Public Comments on Proposed Federal Rules
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AHRA Urges CMS to Reconsider Proposed 60 Percent Cut in Imaging Without Contrast Reimbursements
Carter Struck
WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
August 31, 2026
The Honorable Mehmet C. Oz, MD, MBA
Administrator
Centers for Medicare and Medicaid Services
Attention: CMS-1850-P
P.O. Box 8010
Baltimore, MD 21244-8010
Dear Administrator Oz:
On behalf of AHRA, The Association for Medical Imaging Management, we are pleased to submit the following comments on the 2027 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule (CMS-1850-P). AHRA is ... Show Full Article WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 31, 2026 The Honorable Mehmet C. Oz, MD, MBA Administrator Centers for Medicare and Medicaid Services Attention: CMS-1850-P P.O. Box 8010 Baltimore, MD 21244-8010 Dear Administrator Oz: On behalf of AHRA, The Association for Medical Imaging Management, we are pleased to submit the following comments on the 2027 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule (CMS-1850-P). AHRA isthe professional organization representing management at all levels of hospital imaging departments, freestanding imaging centers, and group practices. Founded in 1973, AHRA's 5000 plus members reach across the country and around the world.
Our comments are focused on CMS's proposal to expand site-neutral payment policies to imaging without contrast, or more formally CMS's "Method to Control Unnecessary Increases in the Volume of Outpatient Services Furnished in Excepted Off-Campus Provider-Based Departments (PBDs)."
Method to Control Unnecessary Increases in the Volume of Outpatient Services Furnished in Excepted Off-Campus Provider-Based Departments (PBDs)
AHRA believes CMS should not finalize their proposal to cut imaging without contrast reimbursements by 60% in 2027. The proposed "method to control unnecessary increases in the volume of outpatient services" is extraordinarily blunt and does not actually align reimbursements for imaging services between the Physician Fee Schedule (PFS) and the Outpatients Prospective Payment System. Furthermore, while AHRA does not endorse this reduction in payment for imaging services, any reimbursement policy change which results in a cut of this magnitude should be implemented over time, not all at once. At a minimum, CMS should implement a payment floor to ensure OPPS reimbursements for imaging without contrast do not fall beneath PFS reimbursements.
When Congress passed the Bipartisan Budget Act of 2015, they grandfathered-in existing off-campus provider-based departments (PBDs) to protect hospital systems from dramatic cuts to their reimbursement. While court decisions have affirmed CMS's authority to expand site-neutral policies into these explicitly grandfathered PBDs, the financial consequences of moving from 100% of OPPS reimbursement to 40% of OPPS reimbursement (the PFS equivalent rate), remain just as relevant as they were when Congress passed Section 603 of the Bipartisan Budget Act of 2015. Specifically, Congress recognized that applying such major cuts overnight to hospital systems whose financial models were built on receiving full OPPS reimbursement, would not only be unfair to those hospitals, but it would also seriously jeopardize the financial viability of hospitals and hospital systems with already thin operating margins.
Additionally, it is critical to preserve reimbursement for excepted off-campus PBDs at the full OPPS rate. As CMS is aware, Medicare reimbursement rates often serve as the reference point for many commercial insurers and Medicaid. As a result, reducing Medicare reimbursement for imaging without contrast to the level proposed will likely lead to similar reductions across other payers, creating an even more significant downstream impact on off campus PBDs. Faced with these reimbursement pressures, many off-campus PBDs may be forced to reevaluate the viability of continuing to offer imaging services without contrast. Such a result, even if partially realized, would reduce the availability essential diagnostic imaging in many community settings and further exacerbate existing patient access challenges, particularly in underserved and rural areas where access to imaging services is already limited.
While AHRA reiterates our opposition to this proposed cut and urges CMS not to move forward with the policy, if CMS ultimately determines that such action is necessary, we encourage the agency to implement the reduction gradually over several years rather than all at once. A phased approach would help mitigate financial disruption for off-campus PBDs and reduce the likelihood of unintended consequences that could further limit patient access to imaging services. When CMS first implemented Section 603 of the Bipartisan Budget Act of 2015, CMS gradually decreased the PFS relativity adjuster to soften the financial impact of the sudden change in reimbursement policy for non-excepted PBD. AHRA suggests that CMS take a similar approach here to give excepted PBDs time to adjust to the new Medicare reimbursement amount.
Furthermore, AHRA believes that CMS should create a payment floor to ensure imaging without contrast services in PBDs is not reimbursement less than it is in freestanding imaging centers. In certain cases, as the following table shows, paying only 40% of the OPPS rate would be significantly less than PFS technical component non-facility rate.
CPT Code
Short Descriptor
2026 PFS Non-Facility Rate (TC)
2026 PFS equivalent rate (40% of OPPS)
70551
Mri brain stem w/o dye
$243
$98
71250
Ct thorax w/o contrast
$106
$42
71550
Mri chest w/o dye
$267
$98
73200
Ct upper extremity w/o dye
$114
$42
76536
US exam of head and neck
$106
$42
AHRA is concerned that the proposed policy =does not equalize payment between OPPS and PFS reimbursement as intended by Congress when they wrote the Bipartisan Budget Act of 2015. In these instances where the HOPPS rate adjusted by the PFS relativity adjuster is significantly less than the actual PFS rate, CMS will be creating a financial incentive to push certain imaging services into independent facilities. CMS should develop a more sophisticated way to align OPPS and PFS services than the current PFS relativity adjuster or at least create a floor which ensures that the new OPPS rate is not significantly less than the PFS rate.
AHRA is concerned that lowering reimbursement for imaging services will not reduce the underlying demand for medically necessary diagnostic imaging. Ordering professionals make imaging decisions based on clinical considerations and patient needs, and therefore are unlikely to change ordering patterns in response to payment reductions affecting hospital-based providers. The practical effect of this policy would be to require imaging departments to absorb significant reimbursement cuts while continuing to provide the same or increased volume of services, placing additional strain on already challenged imaging operations and workforce resources.
As CMS recognizes, hospitals and health systems rely on a balance of both revenue generating and cost intensive services to support their overall mission of patient care. Diagnostic imaging has traditionally served as an important revenue generating service that helps offset the costs of essential, yet often under reimbursed, hospital services. The proposed site-neutral reimbursement reductions would not only reduce resources available to radiology departments, but could also have broader financial implications across the hospital. By diminishing a key source of revenue, the policy could weaken hospitals' ability to sustain other critical clinical services that depend on this support.
For these reasons, AHRA argues that CMS should not apply the method to control imaging without contrast volume (cutting OPPS reimbursement by 60%) as proposed in this rule. If CMS must implement this cut, CMS should do so over time, and in a fashion that truly aligns OPPS and PFS reimbursements.
Conclusion
Your consideration of these comments/questions is appreciated. Should you have any questions or need any additional information, please do not hesitate to contact: Melody Mulaik, MSHS, Chair, AHRA Regulatory Affairs Panel at Melody.Mulaik@rccsinc.com, or Jason Newmark, Executive Director of AHRA at Jnewmark@ahra.org.
Sincerely,
Jason Newmark
Executive Director
______________________________________________________________________________________
490-B Boston Post Road, Suite 200 Sudbury, MA 01776
Toll-Free: (800) 334-2472 Phone: (978) 443-8046 Email: info@ahra.org www.ahra.org
______________________________________________________________________________________
490-B Boston Post Road, Suite 200 Sudbury, MA 01776
Toll-Free: (800) 334-2472 Phone: (978) 443-8046 Email: info@ahra.org www.ahra.org
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2344-1560
August 31, 2026
The Honorable Mehmet C. Oz, MD, MBA
Administrator
Centers for Medicare and Medicaid Services
Attention: CMS-1850-P
P.O. Box 8010
Baltimore, MD 21244-8010
Dear Administrator Oz:
On behalf of AHRA, The Association for Medical Imaging Management, we are pleased to submit the following comments on the 2027 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule (CMS-1850-P). AHRA is ... Show Full Article WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 31, 2026 The Honorable Mehmet C. Oz, MD, MBA Administrator Centers for Medicare and Medicaid Services Attention: CMS-1850-P P.O. Box 8010 Baltimore, MD 21244-8010 Dear Administrator Oz: On behalf of AHRA, The Association for Medical Imaging Management, we are pleased to submit the following comments on the 2027 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule (CMS-1850-P). AHRA isthe professional organization representing management at all levels of hospital imaging departments, freestanding imaging centers, and group practices. Founded in 1973, AHRA's 5000 plus members reach across the country and around the world.
Our comments are focused on CMS's proposal to expand site-neutral payment policies to imaging without contrast, or more formally CMS's "Method to Control Unnecessary Increases in the Volume of Outpatient Services Furnished in Excepted Off-Campus Provider-Based Departments (PBDs)."
Method to Control Unnecessary Increases in the Volume of Outpatient Services Furnished in Excepted Off-Campus Provider-Based Departments (PBDs)
AHRA believes CMS should not finalize their proposal to cut imaging without contrast reimbursements by 60% in 2027. The proposed "method to control unnecessary increases in the volume of outpatient services" is extraordinarily blunt and does not actually align reimbursements for imaging services between the Physician Fee Schedule (PFS) and the Outpatients Prospective Payment System. Furthermore, while AHRA does not endorse this reduction in payment for imaging services, any reimbursement policy change which results in a cut of this magnitude should be implemented over time, not all at once. At a minimum, CMS should implement a payment floor to ensure OPPS reimbursements for imaging without contrast do not fall beneath PFS reimbursements.
When Congress passed the Bipartisan Budget Act of 2015, they grandfathered-in existing off-campus provider-based departments (PBDs) to protect hospital systems from dramatic cuts to their reimbursement. While court decisions have affirmed CMS's authority to expand site-neutral policies into these explicitly grandfathered PBDs, the financial consequences of moving from 100% of OPPS reimbursement to 40% of OPPS reimbursement (the PFS equivalent rate), remain just as relevant as they were when Congress passed Section 603 of the Bipartisan Budget Act of 2015. Specifically, Congress recognized that applying such major cuts overnight to hospital systems whose financial models were built on receiving full OPPS reimbursement, would not only be unfair to those hospitals, but it would also seriously jeopardize the financial viability of hospitals and hospital systems with already thin operating margins.
Additionally, it is critical to preserve reimbursement for excepted off-campus PBDs at the full OPPS rate. As CMS is aware, Medicare reimbursement rates often serve as the reference point for many commercial insurers and Medicaid. As a result, reducing Medicare reimbursement for imaging without contrast to the level proposed will likely lead to similar reductions across other payers, creating an even more significant downstream impact on off campus PBDs. Faced with these reimbursement pressures, many off-campus PBDs may be forced to reevaluate the viability of continuing to offer imaging services without contrast. Such a result, even if partially realized, would reduce the availability essential diagnostic imaging in many community settings and further exacerbate existing patient access challenges, particularly in underserved and rural areas where access to imaging services is already limited.
While AHRA reiterates our opposition to this proposed cut and urges CMS not to move forward with the policy, if CMS ultimately determines that such action is necessary, we encourage the agency to implement the reduction gradually over several years rather than all at once. A phased approach would help mitigate financial disruption for off-campus PBDs and reduce the likelihood of unintended consequences that could further limit patient access to imaging services. When CMS first implemented Section 603 of the Bipartisan Budget Act of 2015, CMS gradually decreased the PFS relativity adjuster to soften the financial impact of the sudden change in reimbursement policy for non-excepted PBD. AHRA suggests that CMS take a similar approach here to give excepted PBDs time to adjust to the new Medicare reimbursement amount.
Furthermore, AHRA believes that CMS should create a payment floor to ensure imaging without contrast services in PBDs is not reimbursement less than it is in freestanding imaging centers. In certain cases, as the following table shows, paying only 40% of the OPPS rate would be significantly less than PFS technical component non-facility rate.
CPT Code
Short Descriptor
2026 PFS Non-Facility Rate (TC)
2026 PFS equivalent rate (40% of OPPS)
70551
Mri brain stem w/o dye
$243
$98
71250
Ct thorax w/o contrast
$106
$42
71550
Mri chest w/o dye
$267
$98
73200
Ct upper extremity w/o dye
$114
$42
76536
US exam of head and neck
$106
$42
AHRA is concerned that the proposed policy =does not equalize payment between OPPS and PFS reimbursement as intended by Congress when they wrote the Bipartisan Budget Act of 2015. In these instances where the HOPPS rate adjusted by the PFS relativity adjuster is significantly less than the actual PFS rate, CMS will be creating a financial incentive to push certain imaging services into independent facilities. CMS should develop a more sophisticated way to align OPPS and PFS services than the current PFS relativity adjuster or at least create a floor which ensures that the new OPPS rate is not significantly less than the PFS rate.
AHRA is concerned that lowering reimbursement for imaging services will not reduce the underlying demand for medically necessary diagnostic imaging. Ordering professionals make imaging decisions based on clinical considerations and patient needs, and therefore are unlikely to change ordering patterns in response to payment reductions affecting hospital-based providers. The practical effect of this policy would be to require imaging departments to absorb significant reimbursement cuts while continuing to provide the same or increased volume of services, placing additional strain on already challenged imaging operations and workforce resources.
As CMS recognizes, hospitals and health systems rely on a balance of both revenue generating and cost intensive services to support their overall mission of patient care. Diagnostic imaging has traditionally served as an important revenue generating service that helps offset the costs of essential, yet often under reimbursed, hospital services. The proposed site-neutral reimbursement reductions would not only reduce resources available to radiology departments, but could also have broader financial implications across the hospital. By diminishing a key source of revenue, the policy could weaken hospitals' ability to sustain other critical clinical services that depend on this support.
For these reasons, AHRA argues that CMS should not apply the method to control imaging without contrast volume (cutting OPPS reimbursement by 60%) as proposed in this rule. If CMS must implement this cut, CMS should do so over time, and in a fashion that truly aligns OPPS and PFS reimbursements.
Conclusion
Your consideration of these comments/questions is appreciated. Should you have any questions or need any additional information, please do not hesitate to contact: Melody Mulaik, MSHS, Chair, AHRA Regulatory Affairs Panel at Melody.Mulaik@rccsinc.com, or Jason Newmark, Executive Director of AHRA at Jnewmark@ahra.org.
Sincerely,
Jason Newmark
Executive Director
______________________________________________________________________________________
490-B Boston Post Road, Suite 200 Sudbury, MA 01776
Toll-Free: (800) 334-2472 Phone: (978) 443-8046 Email: info@ahra.org www.ahra.org
______________________________________________________________________________________
490-B Boston Post Road, Suite 200 Sudbury, MA 01776
Toll-Free: (800) 334-2472 Phone: (978) 443-8046 Email: info@ahra.org www.ahra.org
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2344-1560
American Burn Association Urges CMS to Ensure Fair Payment for Burn Treatments and Advanced Wound Care Technologies
Carter Struck
WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
American Burn Association
141 W. Jackson Blvd., Ste 1920
Chicago, IL 60604
(312) 642-9260 |
info@ameriburn.org
| ameriburn.org
August 31, 2026
The Honorable Mehmet C. Oz, MD, MBA
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1850-P
7500 Security Boulevard
Baltimore, MD 21244-1850
RE: File Code CMS-1850-P; Hospital Outpatient Prospective ... Show Full Article WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. American Burn Association 141 W. Jackson Blvd., Ste 1920 Chicago, IL 60604 (312) 642-9260 | info@ameriburn.org | ameriburn.org August 31, 2026 The Honorable Mehmet C. Oz, MD, MBA Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1850-P 7500 Security Boulevard Baltimore, MD 21244-1850 RE: File Code CMS-1850-P; Hospital Outpatient ProspectivePayment and Ambulatory
Surgical Center Payment Systems; and Quality Reporting Programs; including the
Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality
Program; Request for Information on Strengthening the Standardization and
Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization;
Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act
(EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities To Apply for
Available Slots
Dear Administrator Oz:
On behalf of more than 3,000 burn care professionals and 135 burn centers across the United
States, the American Burn Association (ABA) appreciates the opportunity to comment on the
Centers for Medicare & Medicaid Services' (CMS) proposed rule, Hospital Outpatient
Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting
Programs; including the Hospital Outpatient Quality Reporting Program and Ambulatory
Surgical Center Quality Program; Request for Information on Strengthening the Standardization
and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting
Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and
Notices of Closure of Teaching Hospitals and Opportunities To Apply for Available Slots (CMS-
1850-P)
The ABA supports CMS's proposed valuation of the new Skin Cell Suspension Autograft
(SCSA) codes. However, ABA is concerned with the proposal to continue the CY 2026 skin
substitute product payment methodology, and its impact on acute burn care and reconstruction.
Skin Cell Suspension Autograft
For CY 2027, a new coding structure will be implemented for Skin Cell Suspension Autograft
(SCSA) procedures as CPT codes 15011 through 15018 are replaced. Under the current eight-
code, three-step structure, harvesting, preparation, and application are reported separately. Under
the new structure, these steps are bundled into four CPT codes, 15X19 through 15X22.
The new codes report the complete SCSA procedure based on the anatomic site treated and the
size of the treatment area. Separate primary and add-on codes apply to the first 100 square
centimeters and each additional 100 square centimeters or, for infants and children, the first 1
percent and each additional 1 percent of body area. The new codes are listed below:
CMS proposed to maintain overall payment for the SCSA procedure during the transition
because the change in coding structure does not alter the underlying clinical service or the
resources required to furnish it. In addition, CMS proposed deletion of HCPCS code C8002
because the automated preparation step is incorporated into the new bundled codes.
ABA Comment
The ABA supports CMS's proposed implementation of the new bundled SCSA code family,
CPT codes 15X19 through 15X22, as CPT codes 15011 through 15018 are deleted. The
transition to a simplified four-code structure based on anatomic site and treated surface area
represents a change in how the procedure is reported; it does not alter the underlying clinical
service or the resources required to complete it.
The ABA also supports CMS's proposal to delete HCPCS code C8002 because the automated
preparation step is incorporated into the new bundled SCSA code structure. We urge CMS to
ensure that payment rates for the new CPT codes continue to recognize all resources required to
supply the complete SCSA procedure.
The ABA urges CMS to finalize the proposed APC and status indicator assignments for CPT
codes 15X19 through 15X22 and to maintain overall payment for the procedure. Stable and
accurate payment is essential to preserving access to SCSA treatment for patients with acute
thermal burn injuries, particularly those requiring treatment of large surface areas or
anatomically complex sites.
Skin Substitute Payment Policy
Beginning in CY 2026, CMS established a new methodology under which certain skin substitute
products are paid as incident-to supplies rather than under the ASP methodology. For CY 2027,
CMS proposed replacement of contractor pricing for non-sheet-form skin substitute products
with national payment rates consistent with those established for sheet-form products. For non-
sheet products, CMS would define the reported square centimeters according to the wound
surface area treated rather than the physical dimensions of the product.
The continuation of the CY 2026 skin substitute product payment methodology would continue
treating most skin substitute products as packaged supplies rather than separately payable
biologicals. It would also continue utilizing FDA regulatory classifications to determine product
eligibility. Finally, the current payment methodology would preserve consistent payment policies
across physician offices and hospital outpatient departments.
ABA Comments
Public discussion of skin substitute payment frequently focuses on diabetic foot ulcers and other
chronic wounds. These products also play a distinct and important role in acute burn treatment
and reconstruction. Burn surgeons use advanced skin substitute products for temporary wound
coverage, treatment of partial- and full-thickness burns, reconstruction following excision,
donor-site coverage, salvage of compromised grafts, and complex soft-tissue reconstruction.
Burn patients may require coverage of large and irregular surface areas, multiple applications,
and repeated operative procedures for survival. These circumstances can produce product needs
and acquisition costs that differ significantly from those associated with smaller chronic wounds.
Burn care spans both acute treatment and long-term management of physical and psychological
sequelae. Payment policies developed primarily around chronic wound utilization may not fully
account for the clinical complexity, surface-area requirements, and resource use associated with
burn treatment.
The ABA requests that CMS ensure that payment for sheet and non-sheet products reflects the
reasonable acquisition costs associated with their use in burn care. CMS should also avoid
policies that discourage use of clinically appropriate products solely because the product is not
adequately represented by a broad payment category or regulatory classification.
Assistive Algorithmic Classification of Burn Healing
In 2026, CPT published category III code 0972T - Assistive algorithmic classification of burn
healing (ie, healing or nonhealing) by noninvasive multispectral imaging, including system set-
up and acquisition, selection, and transmission of images, with automated generation of report.
The DeepView AI System (reported with CPT 0972T) provides an objective diagnostic
assessment to predict whether a burn wound will heal without surgical intervention, such as
surgical excision and grafting.
ABA Comments
The ABA commends CMS for its efforts to address the challenges associated with establishing
appropriate payment policies for technologies that utilize AI and software and supports CMS for
proposing to assign AI-based technologies to New Technology APCs with a payment status
indicator O1.
When CPT 0972T was created, it was assigned a payment status indicator of E1 (not covered by
Medicare as a hospital outpatient service), as the technology had not yet received FDA clearance.
In May 2026, the FDA approved DeNovo marketing authorization for the DeepView System.
We anticipate that burn centers will incorporate this device into their practices before the end of
2026. We recommend that CMS assign payment status indicator O1 to CPT 0972 to align with
its proposals for AI and Software as a Medical Service and that CMS assign CPT 0972 to APC
1523 with a payment rate of $2,750.50 to ensure that hospitals are adequately reimbursed for the
per case cost of the software, which is $2,625.
Conclusion
The ABA appreciates CMS's efforts to improve payment accuracy in the OPPS. CMS's
proposed changes to SCSA codes will allow for stronger clinical accuracy when providers report
a service and will allow wider access to burn survivors in need of life altering SCSA procedures.
We ask that CMS ensure that payment for sheet and non-sheet products reflect reasonable
acquisition costs associated with their use in burn care, and for CMS to avoid payment policies
discouraging the use of clinically appropriate products which are not represented by a broad
payment category.
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2344-2051
American Burn Association
141 W. Jackson Blvd., Ste 1920
Chicago, IL 60604
(312) 642-9260 |
info@ameriburn.org
| ameriburn.org
August 31, 2026
The Honorable Mehmet C. Oz, MD, MBA
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1850-P
7500 Security Boulevard
Baltimore, MD 21244-1850
RE: File Code CMS-1850-P; Hospital Outpatient Prospective ... Show Full Article WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. American Burn Association 141 W. Jackson Blvd., Ste 1920 Chicago, IL 60604 (312) 642-9260 | info@ameriburn.org | ameriburn.org August 31, 2026 The Honorable Mehmet C. Oz, MD, MBA Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1850-P 7500 Security Boulevard Baltimore, MD 21244-1850 RE: File Code CMS-1850-P; Hospital Outpatient ProspectivePayment and Ambulatory
Surgical Center Payment Systems; and Quality Reporting Programs; including the
Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality
Program; Request for Information on Strengthening the Standardization and
Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization;
Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act
(EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities To Apply for
Available Slots
Dear Administrator Oz:
On behalf of more than 3,000 burn care professionals and 135 burn centers across the United
States, the American Burn Association (ABA) appreciates the opportunity to comment on the
Centers for Medicare & Medicaid Services' (CMS) proposed rule, Hospital Outpatient
Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting
Programs; including the Hospital Outpatient Quality Reporting Program and Ambulatory
Surgical Center Quality Program; Request for Information on Strengthening the Standardization
and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting
Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and
Notices of Closure of Teaching Hospitals and Opportunities To Apply for Available Slots (CMS-
1850-P)
The ABA supports CMS's proposed valuation of the new Skin Cell Suspension Autograft
(SCSA) codes. However, ABA is concerned with the proposal to continue the CY 2026 skin
substitute product payment methodology, and its impact on acute burn care and reconstruction.
Skin Cell Suspension Autograft
For CY 2027, a new coding structure will be implemented for Skin Cell Suspension Autograft
(SCSA) procedures as CPT codes 15011 through 15018 are replaced. Under the current eight-
code, three-step structure, harvesting, preparation, and application are reported separately. Under
the new structure, these steps are bundled into four CPT codes, 15X19 through 15X22.
The new codes report the complete SCSA procedure based on the anatomic site treated and the
size of the treatment area. Separate primary and add-on codes apply to the first 100 square
centimeters and each additional 100 square centimeters or, for infants and children, the first 1
percent and each additional 1 percent of body area. The new codes are listed below:
CMS proposed to maintain overall payment for the SCSA procedure during the transition
because the change in coding structure does not alter the underlying clinical service or the
resources required to furnish it. In addition, CMS proposed deletion of HCPCS code C8002
because the automated preparation step is incorporated into the new bundled codes.
ABA Comment
The ABA supports CMS's proposed implementation of the new bundled SCSA code family,
CPT codes 15X19 through 15X22, as CPT codes 15011 through 15018 are deleted. The
transition to a simplified four-code structure based on anatomic site and treated surface area
represents a change in how the procedure is reported; it does not alter the underlying clinical
service or the resources required to complete it.
The ABA also supports CMS's proposal to delete HCPCS code C8002 because the automated
preparation step is incorporated into the new bundled SCSA code structure. We urge CMS to
ensure that payment rates for the new CPT codes continue to recognize all resources required to
supply the complete SCSA procedure.
The ABA urges CMS to finalize the proposed APC and status indicator assignments for CPT
codes 15X19 through 15X22 and to maintain overall payment for the procedure. Stable and
accurate payment is essential to preserving access to SCSA treatment for patients with acute
thermal burn injuries, particularly those requiring treatment of large surface areas or
anatomically complex sites.
Skin Substitute Payment Policy
Beginning in CY 2026, CMS established a new methodology under which certain skin substitute
products are paid as incident-to supplies rather than under the ASP methodology. For CY 2027,
CMS proposed replacement of contractor pricing for non-sheet-form skin substitute products
with national payment rates consistent with those established for sheet-form products. For non-
sheet products, CMS would define the reported square centimeters according to the wound
surface area treated rather than the physical dimensions of the product.
The continuation of the CY 2026 skin substitute product payment methodology would continue
treating most skin substitute products as packaged supplies rather than separately payable
biologicals. It would also continue utilizing FDA regulatory classifications to determine product
eligibility. Finally, the current payment methodology would preserve consistent payment policies
across physician offices and hospital outpatient departments.
ABA Comments
Public discussion of skin substitute payment frequently focuses on diabetic foot ulcers and other
chronic wounds. These products also play a distinct and important role in acute burn treatment
and reconstruction. Burn surgeons use advanced skin substitute products for temporary wound
coverage, treatment of partial- and full-thickness burns, reconstruction following excision,
donor-site coverage, salvage of compromised grafts, and complex soft-tissue reconstruction.
Burn patients may require coverage of large and irregular surface areas, multiple applications,
and repeated operative procedures for survival. These circumstances can produce product needs
and acquisition costs that differ significantly from those associated with smaller chronic wounds.
Burn care spans both acute treatment and long-term management of physical and psychological
sequelae. Payment policies developed primarily around chronic wound utilization may not fully
account for the clinical complexity, surface-area requirements, and resource use associated with
burn treatment.
The ABA requests that CMS ensure that payment for sheet and non-sheet products reflects the
reasonable acquisition costs associated with their use in burn care. CMS should also avoid
policies that discourage use of clinically appropriate products solely because the product is not
adequately represented by a broad payment category or regulatory classification.
Assistive Algorithmic Classification of Burn Healing
In 2026, CPT published category III code 0972T - Assistive algorithmic classification of burn
healing (ie, healing or nonhealing) by noninvasive multispectral imaging, including system set-
up and acquisition, selection, and transmission of images, with automated generation of report.
The DeepView AI System (reported with CPT 0972T) provides an objective diagnostic
assessment to predict whether a burn wound will heal without surgical intervention, such as
surgical excision and grafting.
ABA Comments
The ABA commends CMS for its efforts to address the challenges associated with establishing
appropriate payment policies for technologies that utilize AI and software and supports CMS for
proposing to assign AI-based technologies to New Technology APCs with a payment status
indicator O1.
When CPT 0972T was created, it was assigned a payment status indicator of E1 (not covered by
Medicare as a hospital outpatient service), as the technology had not yet received FDA clearance.
In May 2026, the FDA approved DeNovo marketing authorization for the DeepView System.
We anticipate that burn centers will incorporate this device into their practices before the end of
2026. We recommend that CMS assign payment status indicator O1 to CPT 0972 to align with
its proposals for AI and Software as a Medical Service and that CMS assign CPT 0972 to APC
1523 with a payment rate of $2,750.50 to ensure that hospitals are adequately reimbursed for the
per case cost of the software, which is $2,625.
Conclusion
The ABA appreciates CMS's efforts to improve payment accuracy in the OPPS. CMS's
proposed changes to SCSA codes will allow for stronger clinical accuracy when providers report
a service and will allow wider access to burn survivors in need of life altering SCSA procedures.
We ask that CMS ensure that payment for sheet and non-sheet products reflect reasonable
acquisition costs associated with their use in burn care, and for CMS to avoid payment policies
discouraging the use of clinically appropriate products which are not represented by a broad
payment category.
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2344-2051
ACS Urges CMS to Extend Separate Payment for Non-Opioid Pain Treatments and Develop Robust Outpatient Surgical Quality Measures
Carter Struck
WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
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August 31, 2026
Mehmet Oz, MD, MBA
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS-1850-P
P.O. Box 8010
Baltimore, MD 21244-8010
RE:
Hospital Outpatient Prospective Payment and Ambulatory Surgical Center
Payment Systems; and Quality Reporting Programs; including the Hospital
Outpatient Quality Reporting Program and Ambulatory Surgical ... Show Full Article WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. 1 August 31, 2026 Mehmet Oz, MD, MBA Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-1850-P P.O. Box 8010 Baltimore, MD 21244-8010 RE: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; including the Hospital Outpatient Quality Reporting Program and Ambulatory SurgicalCenter Quality
Program; Request for Information on Strengthening the Standardization and
Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization;
Accrediting Organization (AO) Deeming for Emergency Medical Treatment and
Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and
Opportunities To Apply for Available Slots (CMS-1850-P)
Dear Administrator Oz:
On behalf of the over 95,000 members of the American College of Surgeons (ACS), we appreciate the opportunity to submit comments on the calendar year (CY) 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule published in the Federal Register on July 7, 2026.
ACS is a scientific and educational association of surgeons founded in 1913 to improve the quality of care for the surgical patient by setting high standards for surgical education and practice. Since a large portion of surgical care is furnished in hospital outpatient departments (HOPDs) and ASCs, the College has a vested interest in CMS' coverage, reimbursement, and quality reporting requirements applicable to these settings. With our more than 100-year history in developing policy recommendations to optimize the delivery of surgical services, lower costs, improve program integrity, and make the U.S. healthcare system more effective and accessible, we believe that we can offer insight to the Agency's proposed modifications to the hospital outpatient and ASC payment systems for calendar year (CY) 2027. Our comments below are presented in the order in which they appear in the rule.
PAYMENT AND POLICIES RELATED TO HOSPITAL OUTPATIENT DEPARTMENTS
Proposed Changes to Packaged Items and Services
Implementation of Section 4135 of the Consolidated Appropriations Act, 2023
Section 4135 of the Consolidated Appropriations Act, 2023 (CAA, 2023), commonly referred to as the "NOPAIN Act," requires CMS to make temporary separate payments for qualifying non-opioid treatments furnished from January 1, 2025, through December 31, 2027, rather than package those payments into the associated outpatient service. As a result, CMS proposes to continue providing separate payment for qualifying non-opioid treatments for pain relief furnished in HOPDs and ASCs, consistent with policies finalized as part of CY 2025 and CY 2026 OPPS/ASC rulemaking.
ACS supports CMS' proposal to maintain separate payment for CY 2027. ACS also urges CMS to explore a pathway for continuing separate or additional payment for non-opioid pain management treatments beyond 2027 when the NOPAIN Act provisions expire. As part of this evaluation, CMS should also reconsider the methodology and evidence it uses to determine when separate payment for non-opioid alternatives is warranted, as discussed in greater detail below.
The SUPPORT for Patients and Communities Act provides an important basis for such a review. Section 6082 of the SUPPORT Act added sections 1833(t)(22) and 1833(i)(8) to the Social Security Act (SSA), directing CMS to review OPPS and ASC payments for opioids and evidence-based non-opioid alternatives to ensure that Medicare payment does not create financial incentives favoring opioids over non-opioid alternatives. For the OPPS, section 1833(t)(22) expressly permits CMS to conduct subsequent reviews and directs the Agency to consider whether payment revisions would reduce such incentives. Section 1833(i)(8) directs CMS to conduct a similar review and make appropriate revisions under the ASC payment system.
ACS urges CMS to conduct a subsequent review under these authorities before the NOPAIN Act payment policy expires. In doing so, CMS should use the experience gained under the CY 2025-2027 separate payment policy both to evaluate the need for continued separate payment and to reassess the analytical framework it uses to determine whether packaging creates a financial barrier to non-opioid alternatives.
In prior rulemaking, CMS relied in significant part on Medicare claims data for individual drugs before and after expiration of pass-through payment status to determine whether packaging created a barrier to utilization. ACS has previously expressed concern that this approach is too narrow and may exclude other factors that may be stronger indicators of the accessibility and use of opioid-sparing therapies by physicians and facilities. Changes in utilization following expiration of pass-through status may be informative, but they do not fully capture the range of financial and operational factors that may affect access to non-opioid pain management alternatives.
By the end of CY 2027, CMS will have three years of experience with separate payment for qualifying treatments across both HOPDs and ASCs, providing an opportunity for a more comprehensive assessment than was possible under its earlier analyses. ACS encourages CMS to evaluate a broader range of evidence, including changes in utilization under separate payment; the acquisition costs of non-opioid treatments relative to packaged payments; differences across sites of service and surgical procedures; limitations in claims data for packaged services; and other indicators of beneficiary access. CMS should also seek input from surgeons, facilities, beneficiaries, and other stakeholders regarding whether payment policy affects clinical decision-making, access to non-opioid treatments, or the adoption of opioid-sparing therapies. Allowing the current separate payment policy simply to expire without a comprehensive assessment could recreate the same concerns that prompted Congress to pass the NOPAIN Act.
Accordingly, ACS requests that CMS use the period before expiration of the NOPAIN Act payment policy to evaluate the effects of separate payment, conduct a subsequent review under its existing statutory authority, and identify a pathway for maintaining appropriate payment for evidence-based non-opioid pain management alternatives in CY 2028 and future years.
New Technology APCs
CY 2027 Proposals for SaMS Procedures Currently Assigned to New Technology APCs
CMS observes that software-based technologies with novel functionalities, including artificial intelligence (AI) used to support clinical decision-making, are increasingly used and available to providers. However, a consistent,
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tailored payment pathway is still lacking. CMS notes that it has taken steps to assess and evaluate payment pathways but needs additional data to resolve the underlying valuation challenges. For CY 2027, CMS proposes three changes:
1. Change existing terminology for Software as a Service (SaaS) to Software as a Medical Service (SaMS) to distinguish these technologies from the common commercial meaning of software as a service;
2. Designate 36 Healthcare Common Procedure Coding System (HCPCS) codes as SaMS technologies and, of these, reassign 21 HCPCS codes currently paid separately (status indicator "S") under Clinical Ambulatory Payment Classifications (C-APCs) into New Technology APCs at rates aligned with CY 2026. Codes conditionally packaged (status indicator "Q1") retain their existing C-APC and packaging assignments; and
3. Create a new status indicator "O1" (SaMS, Paid under OPPS, separate APC payment) under OPPS for SaMS. Assign all services proposed to designate as SaMS to status indicator "O1." Status indicator "O1" would have the same payment specifications as status indicator "S," to allow for separate payment.
ACS supports CMS's recognition that a tailored payment pathway for SaMS is needed and that clinical APCs built around material resources do not fit software. To strengthen both interim and future methodologies, ACS recommends that CMS: 1) confirm that SaMS payment is independent of physician work valuations; 2) clarify how procedural and intraoperative AI-based technologies are treated relative to SaMS; 3) extend the SaMS pathway to the ASC setting; and 4) define a data plan and transparent exit criteria for New Technology APC placement.
Clinical Ambulatory Payment Classifications (APCs) group services with comparable clinical characteristics and resource costs and determine payments on this basis. However, the value of SaMS technology lies within a validated algorithm, the data and model development, and its clinical performance. These elements have not historically been captured by the resource assumptions that make up clinical APCs. Forcing software into these groupings does not align with what the service actually contributes and drives the rate variation across comparable technologies that CMS identifies. A dedicated pathway is the necessary first step toward valuing SaMS in a way that aligns with its contributions and generates the consistent data a permanent methodology requires.
As CMS evaluates these pathways and takes steps toward a more permanent solution, ACS asks CMS to explicitly state that separate SaMS payment does not imply reduced physician work and is not evidence of efficiency gains. SaMS technologies are designed to augment, not replace, physicians' clinical judgment. The physician remains responsible for reviewing and interpreting software outputs, appropriately applying outputs to clinical decisions, and communicating with patients. Creating a separate payment for SaMS is not an indication of changes in time, intensity, or complexity of professional work. Therefore, ACS asks CMS to make it clear that SaMS payment is in addition to, and independent of, the valuation of physician work, and that the adoption of these tools will not be misinterpreted as an efficiency adjustment to the corresponding professional service.
In addition, since the HCPCS codes designated for the new technology APCs for 2027 are primarily focused on diagnostic and decision-support systems, ACS asks CMS to define how procedural and intraoperative AI-based technologies relate to SaMS and, if they fall outside that definition, which payment pathway applies. AI is increasingly embedded in the procedural and intraoperative environment. Examples of these tools for surgery are real-time image guidance and navigation, computer-vision, and intraoperative analytics that inform operative decisions. It is unclear from the statements in the proposed rule whether procedural and/or intraoperative AI-based technologies fall within the SaMS definition. Without this clarity, there is risk that these technologies would not be recognized as SaMS or accounted for in other payment pathways, which could ultimately discourage development and uptake in surgical care.
ACS also recommends that CMS establish a parallel SaMS payment pathway in the ASC setting. As CMS continues to phase out the Inpatient Only (IPO) List and expand the ASC covered procedures list, the number of surgical procedures, including complex procedures, in this setting will continue to grow. Without a payment pathway for SaMS in ASC settings, ASCs that adopt the same technology will have no path to payment. Ultimately, this could result in a technology gap that could distort where procedures are performed.
Finally, we ask CMS for a data plan, including how hospitals report subscription and enterprise license costs and transparent exit criteria for New Technology APC placement. New technology APCs are intended to be a temporary placement until sufficient data exists to price a service within the broader APC structure. However, SaMS costs are frequently incurred through subscriptions, enterprise license costs, and per-use or per-click arrangements that do not map cleanly into the current OPPS rate setting process. If these costs are reported inconsistently, it will be difficult to support reliable valuations, which could result in a permanent payment pathway built on flawed data.
SERVICES THAT WILL BE PAID ONLY AS INPATIENT SERVICES
Proposed CY 2027 Changes to IPO List
CMS proposes to continue its policy of eliminating the IPO list, the list that identifies services for which Medicare will make payment only when furnished in the inpatient hospital setting due to the invasive nature of the procedures, the underlying physical condition of the Medicare patient, or the need for at least 24 hours of postoperative recovery time or monitoring before the patient can be safely discharged. CY 2027 will be the second year of the transitional period with the list being completely phased out by CY 2029. The Agency proposes to remove 637 services, or approximately half of the remaining IPO services, from the list for CY 2027, making these services eligible for Medicare payment in the hospital outpatient setting in addition to the inpatient setting.
ACS continues to strongly oppose the elimination of the IPO list. While advances in surgical technique, anesthesia, and perioperative care have allowed certain procedures historically performed on an inpatient basis to be safely furnished in the outpatient setting for carefully selected patients, the continued elimination of the IPO list has implications that extend well beyond whether a procedure technically can be performed on an outpatient basis. These concerns are particularly significant because CMS proposes to remove 637 additional services from the IPO list for CY 2027, including a substantial number of major surgical procedures.
Removal of a procedure from the IPO list does not make the procedure less complex, reduce the resources necessary to perform it, or mean that every patient receiving the procedure can appropriately be treated on an outpatient basis. Nor does removal from the IPO list establish that the existing OPPS APC structure can appropriately accommodate the procedure.
As stated in our previous comments to CMS, we agree with the removal of certain services from the IPO list for which there is evidence that they can safely be furnished in the outpatient setting. However, we are extremely concerned by the Agency's proposed removal of various IPO procedures that do not have sufficient data to support the appropriateness of their performance on an outpatient basis.
Patient Safety, Quality, and Access to Surgical Care
We remain concerned that the elimination of the IPO list makes major and complex procedures that typically require extensive inpatient treatment payable in outpatient sites of service. This policy change raises concerns about safety and quality of care. Even with advancements in medical practice and technology, certain care is too complex to be provided safely in the outpatient setting. Cost and feasibility should not be the only considerations when determining which procedures can be done in outpatient settings. Surgical patients may face more risk in the post-operative period or have comorbidities that require the resources and capabilities of an inpatient setting to prevent or manage complications, including the ability to render timely and necessary interventions to prevent patient death. Evaluating risk with clinical outcomes data to examine pre- and post-operative morbidity and mortality outcomes is critical for making site of service determinations. Analysis of procedures on the IPO list using risk-adjusted clinical data, such as those from ACS National Surgical Quality Improvement Program (NSQIP) registry, can provide insights into safety and appropriateness to determine which procedures can be safely and effectively done in outpatient settings.
Additionally, the next generation of quality measures for the outpatient setting should be patient-centered and tied to the condition(s) and surgical procedure(s) under consideration. They must also track patients across the full episode of care and should not only focus on the care managed within an outpatient setting. Currently, quality mechanisms available for the outpatient setting differ greatly from those in inpatient settings. To date, the majority of efforts to measure quality, especially in surgery, have focused on the inpatient setting. To optimally care for patients in inpatient settings, we have developed capabilities to track outcomes, processes, structures, and patient experience delivered by care teams. This multi-faceted approach to quality is lacking in the outpatient setting, making it difficult to truly understand how complications are managed during and after outpatient procedures, how care teams function, and if care met patient goals. As CMS looks to transition more care to outpatient settings, it is important that it works with clinical experts and relevant specialty societies to build out meaningful and effective quality standards that focus on the patient and equip care teams to deliver optimal care and meet patient goals and expectations.
Out-of-Pocket Costs
We continue to be concerned by the implications that the inevitable mass shift of procedures to the outpatient setting will have on the accessibility and affordability of care for Medicare beneficiaries. Per CMS rules, the copayment for a single outpatient hospital service cannot be more than the inpatient hospital deductible; however, a patient's total copayment for the cumulative cost of all outpatient services related to a single procedure may exceed the inpatient hospital deductible.1
ACS does not support any policies, such as the elimination of the IPO list, which will inappropriately shift costs onto patients and therefore discourage beneficiaries from seeking necessary care.
Medicare Advantage and Commercial Insurer Coverage
Other insurers, including Medicare Advantage Organizations (MAOs), may also use the lack of the IPO list to inappropriately force care into the outpatient setting purely to generate cost-savings for their plans. CMS itself noted that stakeholders have indicated that removing a service from the IPO list creates expectations that the service must be furnished in the outpatient setting "regardless of the clinical judgment of the physician or needs of the patient."2 This policy risks creating an inequitable system in which Medicare Advantage beneficiaries are effectively forced into the outpatient setting for surgical procedures with potentially adverse implications for quality and cost of care. In contrast, beneficiaries enrolled in Original Medicare would continue to have coverage for the same procedure in either the inpatient or outpatient setting based on their clinical needs.3 Peer-reviewed studies have demonstrated that MAOs deny up to 17 percent of initial claims, and one in three Medicare Advantage beneficiaries experience at least one claim denial annually.4 While most of these denials are ultimately overturned on appeal, the appeals process itself delays care and imposes administrative burden on surgical practices. Eliminating the IPO list would significantly heighten the likelihood that MAOs will deny coverage for medically necessary inpatient surgical procedures and only approve outpatient coverage, thereby restricting beneficiary access to the most clinically appropriate site of service.
While we understand CMS is committed to eliminating the IPO list, ACS urges CMS to reconsider the pace of that elimination and to revisit its annual IPO list review process for identifying procedures that should be 1 Centers for Medicare & Medicaid Services. Inpatient or outpatient hospital status affects your costs. Accessed August 20, 2026. https://www.medicare.gov/what-medicare-covers/what-part-a-covers/inpatient-or-outpatient-hospital-status 2 85 Fed. Reg. 48772 (August 12, 2020). 3 Gondi S, Kadakia KT, Tsai TC. Coverage Denials in Medicare Advantage - Balancing Access and Efficiency. JAMA Health Forum. 2024;5(3):e240028. 4 Vabson B, Hicks AL, Chernew ME. Medicare Advantage Denies 17 Percent of Initial Claims; Most Denials Are Reversed, But Provider Payouts Dip 7 Percent. Health Aff (Milwood). 2025;44(6):702-706. 6
added to or removed from the list. That process gives stakeholders an opportunity to provide input and has historically been an effective mechanism for gathering reliable and objective clinician data on the safety and efficacy of procedures furnished in the outpatient setting. In the absence of slowing down the elimination, ACS requests that CMS conduct a study to review the effects of the elimination of the IPO list on patient safety, beneficiary cost-sharing, changes in behavior of MA and private insurance, and patient access to surgical care. High-quality surgical care involves much more than providing services at the lowest possible cost. As noted above, complications can occur with any surgical procedure, particularly during the post-operative period. For many services on the IPO list, such complications will be best identified early and treated promptly in the inpatient hospital setting. We believe that CMS would greatly benefit from coordinating with the surgical community to identify which specific procedures on the existing IPO list may be safely provided in an outpatient setting, instead of simply removing all procedures from the list.
APC-Specific Placements
General Assignment Policy for Procedures Removed from IPO List
As CMS proceeds with the elimination of the IPO list, CMS is required to set payment rates for these procedures in the outpatient setting. This includes assignment to Ambulatory Payment Classifications (APCs) intended to reflect clinical and resource homogeneity of the procedures that are included. ACS does not recommend wholesale restructuring of the OPPS based solely on the former inpatient status of a service. However, there are several examples (inventoried below) of the procedures proposed for CY 2027 that do not fit appropriately within the existing APC structure.
ACS is concerned that for procedures that had previously been performed only in the inpatient setting, CMS' approach to assign these cases to existing APCs could inhibit true clinically appropriate site-of-service selection if the procedure in the outpatient setting is under-resourced. OPPS rate setting is dependent on claims data and cost-to-charge ratios, but CMS does not have any access to this information for these cases in the outpatient setting because they have only been performed in the inpatient setting. We are concerned that the approach to move these formerly-inpatient only procedures into existing APCs in the absence of that data could result in inaccurate payments, potentially even exacerbating concerns about financially-driven hospital or health system site-of-service pressure. While theoretically over time, the system could move toward accurate payment due to CMS' policies for variation in APCs and regulations to reconfigure APCs under the "2 Times Rule," we are concerned the correction will not occur because CMS so often declares exceptions for violations of the "2 Times Rule" due to low volume rather than reconfiguring the affected APC.
In order to avoid these unintended consequences and create data driven APC definitions and assignments, ACS encourages CMS to explore APC creation and assignment for procedures coming off the IPO List modeled after CMS' new technology APCs that more directly address the resources required to provide a service.
This would allow CMS to estimate the outpatient resources needed to deliver a service using available inpatient data, without disturbing or skewing the APC parameters or payment rates for existing APC families. We believe that if these procedures truly can be performed in the outpatient setting, physician-directed, clinically appropriate site of service selection is dependent on the appropriate resourcing of those procedures in each setting, thus removing financial incentives to perform in one site of service over another. These placements in new technology-like APCs with descriptors defined by the reimbursement amount will allow CMS to collect claims and costs data on these procedures if they are performed in the outpatient setting for appropriate APC placement. If they are not, then eventually CMS should address assignment of these procedures via its standing low volume policies.
In the alternative, CMS could restructure the three-year phase-out of the IPO list as a timetable for careful review, not a deadline that requires CMS to remove a service before an appropriate outpatient payment methodology exists. Where additional clinical and resource analysis is necessary, CMS should retain the procedure on the IPO list for CY 2027 and reconsider it in the next phase. Where removal is appropriate, but the proposed APC is not, CMS should revise the APC assignment before finalizing the policy.
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ACS also urges CMS to use the CY 2028 rulemaking process to conduct a more deliberate review of the remaining surgical families and to work with the relevant specialty societies before proposing removal of procedures for which appropriate outpatient clinical comparators and resource data are limited.
ACS Recommendations Regarding Specific CY 2027 IPO Removals and APC Assignments
ACS reviewed a number of the procedures proposed for removal from the IPO list and their corresponding proposed APC assignments. That review reinforces our broader concerns regarding the pace of the IPO phase-out. Several of the proposed assignments do not appear to reflect either the clinical characteristics or expected hospital resources associated with these major surgical procedures.
CMS states that the clinical families selected for CY 2027 generally require less adjustment to existing APCs than the services expected to be addressed in CY 2028. CMS also acknowledges that many of the remaining procedures are more complex and may require a lengthier review process and changes to the current APC structure. ACS believes the same approach should apply to CY 2027 procedures for which the proposed APC assignment demonstrates that additional review is necessary.
CMS should not allow the predetermined schedule for eliminating the IPO list to dictate payment policy. Where CMS cannot identify an existing APC that is clinically and resource homogeneous with a procedure proposed for removal, ACS recommends that CMS retain the procedure on the IPO list for CY 2027 and reconsider it during the CY 2028 phase after CMS has had additional time to evaluate the procedure and, where necessary, restructure or create an appropriate APC.
Where ACS provides an alternative APC recommendation below, that recommendation should not be interpreted as agreement that the procedure is appropriate for removal from the IPO list. For several services, ACS believes continued IPO status is the preferable policy. The alternative APC recommendation addresses the payment that should apply if CMS nevertheless proceeds with removal.
Priority Recommendations
Procedure / CPT Codes
CMS Proposed Assignment
ACS Recommendation
Primary Concern
Necrotizing infection debridement 11004-11006
APC 5053 Level 3 Skin Procedures~$851
Retain on IPO list for CY 2027. If removed, assign to a substantially higher surgical APC. Sepsis, extensive operative debridement, anesthesia, and frequent ICU/step-down needs.
Laparoscopic Heller myotomy 43279
APC 5162 Level 2 ENT Procedures~$599
Retain on IPO list until an appropriate APC is identified; if removed, assign to an appropriate laparoscopic GI APC. Clinical homogeneity problem; abdominal laparoscopic procedure assigned to an ENT APC.
Major open gastric procedures selected 43500-43820
APC 5301 Level 1 Upper GI Procedures~$1,054
Defer the highest-resource procedures to the CY 2028 phase while CMS develops appropriate APC treatment. Major open operations, often requiring laparotomy and multi-day postoperative care.
Open small-bowel resection / reconstruction 44120, 44125, 44130
APC 5303 Level 3 Upper GI Procedures~$4,306
If removed, evaluate APC 5342 or another higher abdominal surgical APC. Resection and reconstruction are more resource intensive than exploration/decompression services in the same APC.
Major open colectomy 44140, 44141, 44143-44147, 44150, 44155, 44160
APC 5341 Level 1 Abdominal/Peritoneal/Biliary~$4,146
If removed, assign to APC 5342 at minimum. Payment hierarchy is difficult to reconcile with routine laparoscopic colectomy in higher-paying APC 5361.
Complex laparoscopic colorectal 44210-44212
APC 5361 Level 1 Laparoscopy~$7,109
If removed, reassign to APC 5362 (~$12,300). Total colectomy/proctocolectomy and pouch-type procedures are not homogeneous with routine laparoscopic cases.
Complex pelvic surgery 45119, 45126, 45136, 45397
APC 5342~$7,715
Retain highest-resource procedures on IPO list while CMS evaluates a higher-level Complex Abdominal/Pelvic C-APC. Existing APC does not adequately distinguish the most extensive pelvic operations, including pelvic exenteration.
Presacral / sacrococcygeal tumor excision 49215
APC 5073 Level 3 Excision/Biopsy/I&D~$3,320
Retain on IPO list until an appropriate APC exists; if removed, APC 5342 at minimum or new complex pelvic APC. Deep pelvic operation is not clinically/resource comparable to routine excision, biopsy, or I&D.
Major hepatic resections including 47120, 47122, 47125, 47130
APC 5341~$4,146
Retain highest-resource resections on IPO list for CY 2027; conduct procedure-level APC review. Major liver resections warrant more granular review than placement in a Level 1 abdominal APC.
Major pancreatic resections 48140, 48145, 48146, 48150, 48152-48155
APC 5341~$4,146
Retain on IPO list for CY 2027 and reconsider during CY 2028 after CMS evaluates appropriate APC structure and resource requirements rather than assigning major pancreatic surgery to a Level 1 abdominal APC simply to maintain the IPO elimination timetable.
Necrotizing Soft-Tissue Infection Debridement - CPT Codes 11004-11006
ACS strongly recommends that CMS retain Current Procedural Terminology (CPT) codes 11004-11006 on the IPO list for CY 2027. These procedures describe extensive operative debridement for necrotizing soft-tissue infection involving the perineum, external genitalia, or abdominal wall. Patients appropriately receiving these services may be septic and may require intensive care unit (ICU) or step-down care.
CMS proposes to assign these services to APC 5053, Level 3 Skin Procedures, with a proposed payment of approximately $851. ACS does not believe this assignment reflects the operative intensity, anesthesia requirements, extent of debridement, or postoperative resources associated with treatment of necrotizing infection.
If CMS nevertheless removes these codes from the IPO list, ACS urges CMS to place them in a substantially higher surgical APC based on the expected resources of the service. At a minimum, CMS should evaluate APC 5073 or another appropriate abdominal/perineal surgical APC rather than treating these procedures as Level 3 skin procedures.
Laparoscopic Heller Myotomy - CPT Code 43279
ACS recommends that CMS reconsider both the removal and proposed APC assignment for CPT code 43279. CMS proposes to assign laparoscopic Heller myotomy to APC 5162, Level 2 ENT Procedures, with a proposed payment of approximately $599. The assignment itself raises an obvious question regarding clinical homogeneity. A laparoscopic Heller myotomy is an abdominal minimally invasive surgical procedure and should not be grouped with Level 2 Otolaryngology (ENT) procedures. ACS recommends that CMS retain CPT code 43279 on the IPO list for CY 2027 unless and until an appropriate OPPS APC is identified. If CMS proceeds with removal, the code should be reassigned to an appropriate laparoscopic gastrointestinal (GI) APC based on clinical and resource similarity.
Major Open Gastric Procedures
ACS has substantial concerns regarding the assignment of numerous major open gastric procedures to APC 5301, Level 1 Upper GI Procedures, with a proposed payment of approximately $1,054. The proposed group includes open gastric repair and resection, partial gastrectomy, pyloroplasty, gastroduodenostomy, and other major open operations.
These procedures may require a large laparotomy and substantial postoperative hospital care. ACS does not believe that assigning the highest-resource major open gastric operations to a Level 1 Upper GI APC appropriately reflects their clinical characteristics or expected resource use.
ACS recommends that CMS retain the highest-resource major open gastric procedures on the IPO list for CY 2027 and reconsider them as part of the CY 2028 phase. This additional time would allow CMS to determine whether an existing higher-level abdominal APC is appropriate or whether additional APC restructuring is necessary.
Major Open Small-Bowel Resection and Reconstruction - CPT Codes 44120, 44125, and 44130
CMS proposes to assign CPT codes 44120, 44125, and 44130 to APC 5303, Level 3 Upper GI Procedures, with a proposed payment of approximately $4,306. APC 5303 may be a reasonable category for certain exploration, adhesiolysis, or decompression services, but intestinal resection and reconstruction are more resource intensive. ACS urges CMS to reassess these services individually. If CMS removes these codes from the IPO list, APC 5342 or another higher-level abdominal surgical APC should be considered based on the expected resource requirements of each procedure.
Major Open Colectomy - CPT Codes 44140, 44141, 44143-44147, 44150, 44155, and 44160
The proposed treatment of open colectomy provides a clear example of an internally inconsistent payment hierarchy. CMS proposes to assign major open colectomy procedures to APC 5341, Level 1 Abdominal/Peritoneal/Biliary and Related Procedures, with a proposed payment of approximately $4,146.
At the same time, routine laparoscopic colectomy procedures are assigned to APC 5361, Level 1 Laparoscopy and Related Services, with a proposed payment of approximately $7,109, while more complex laparoscopic procedures in APC 5362 receive approximately $12,300. ACS does not believe the expected hospital resources associated with major open colectomy are appropriately reflected by a payment hierarchy under which the open procedure is assigned substantially fewer resources than a routine laparoscopic colectomy.
ACS recommends that, if these services are removed from the IPO list, the major open colectomy family be assigned to APC 5342 at minimum rather than APC 5341.
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Complex Laparoscopic Colorectal Surgery - CPT Codes 44210-44212
CMS proposes to assign CPT codes 44210, 44211, and 44212 to APC 5361, Level 1 Laparoscopy and Related Services, with a proposed payment of approximately $7,109. These services include total colectomy, proctocolectomy, and restorative procedures that are considerably more complex than routine laparoscopic colectomy and ostomy services within APC 5361. ACS recommends that CPT codes 44210-44212 be reassigned to APC 5362 if CMS finalizes their removal from the IPO list.
Complex Abdominal and Pelvic Surgery
ACS is particularly concerned that the existing APC structure may not provide an appropriate category for some of the most complex abdominal and pelvic procedures proposed for removal. CMS proposes to assign CPT codes 45119, 45126, 45136, and 45397 to APC 5342, with a proposed payment of approximately $7,715. These procedures include highly complex rectal and pelvic operations. Pelvic exenteration, CPT code 45126, is an especially clear example of a procedure that is not clinically or resource homogeneous with substantially less extensive procedures assigned to the same APC.
ACS recommends that CMS retain the highest-resource complex pelvic procedures on the IPO list for CY 2027 while it evaluates development of a higher-level Complex Abdominal/Pelvic C-APC. CMS should use the CY 2028 rulemaking cycle to propose and seek comment on an appropriate payment structure rather than moving these procedures into an APC that does not adequately reflect their complexity.
Presacral/Sacrococcygeal Tumor Excision - CPT Code 49215
CMS proposes to assign CPT code 49215 to APC 5073, Level 3 Excision/Biopsy/Incision and Drainage, with a proposed payment of approximately $3,320. This is a deep pelvic/presacral operation and is not clinically or resource comparable to routine excision, biopsy, or incision-and-drainage procedures. ACS recommends that CMS retain CPT code 49215 on the IPO list until an appropriate APC is available. If CMS proceeds with removal for CY 2027, ACS recommends assignment to APC 5342 at minimum or inclusion in a new complex pelvic APC.
Major Hepatic Procedures
CMS proposes to assign a number of major open hepatic procedures, including CPT codes 47120, 47122, 47125, and 47130, to APC 5341, with a proposed payment of approximately $4,146.
ACS believes the major hepatic resections warrant procedure-level review before removal from the IPO list. Major hepatic resections should not be moved into the OPPS solely because APC 5341 is the nearest existing abdominal category. CMS should retain the highest-resource hepatic procedures on the IPO list for CY 2027 and evaluate whether APC 5342, a newly structured higher-level abdominal APC, or another payment approach is appropriate.
Major Pancreatic Surgery
ACS has even greater concerns regarding major pancreatic procedures. CMS proposes to assign numerous pancreatic operations, including CPT codes 48140, 48145, 48146, 48150, 48152, 48153, 48154, and 48155, to APC 5341, with a proposed payment of approximately $4,146.
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These services include partial pancreatic resections and other major pancreatic operations. ACS does not believe the proposed assignment demonstrates that these procedures are clinically or resource homogeneous with the other services assigned to APC 5341.
ACS recommends that CMS retain major pancreatic resections on the IPO list for CY 2027 and reconsider their removal during the CY 2028 phase. CMS should use that additional time to evaluate appropriate APC structure and resource requirements rather than assigning major pancreatic surgery to a Level 1 abdominal APC simply to maintain the IPO elimination timetable.
HOSPITAL OUTPATIENT QUALITY REPORTING PROGRAM
The phased elimination of the IPO list represents a significant policy shift that will not only drive more procedures into outpatient and ambulatory settings, but also lead to greater complexity in the procedures performed there. As higher-acuity patients and complex orthopedic, cardiac, and other procedures migrate into hospital outpatient departments, the Hospital Outpatient Quality Reporting (OQR) and Ambulatory Surgery Center Quality Reporting (ASCQR) Programs' measure sets that are designed to evaluate lower-acuity populations may not capture the risks and outcomes that matter most to patients. Because of changes in site of service and patient mix, the CMS OQR and ASCQR programs require a re-evaluation of their quality models. ACS advocates for a programmatic quality framework to assess a broader aspect of clinical care, such as surgery in older adults as one extremely relevant example. Programmatic quality metrics are multifaceted performance metrics that align various measurement strategies to better coordinate quality measurement with frontline care teams. Unlike traditional single measures, such as surgical site infection rates, programmatic measures integrate: structural elements (e.g., staffing, resources, infrastructure), processes (e.g., care delivery steps), and outcomes (e.g., patient goal attainment).5 Together, these measures are designed to be comprehensive and patient-centric, and aligned to reduce the burden of excessive metrics while ensuring that quality goals are realistic and supported by adequate resources. Below, we outline how a programmatic quality model that includes structures, key processes, and outcomes could be designed around geriatric surgery patients in the outpatient setting.
1) Structural Components. ACS advocates for the implementation of key structures, based on evidence that orchestrate high-performing care teams to work within a system that has the right structures and processes in place to deliver on the optimal care pathway. For geriatric surgery, as an example, this might include identified staff roles to support geriatric surgery efforts. These types of systems also give care teams the tools to manage patients when rescue strategies are identified and needed, which may become more prevalent in outpatient settings as complexity grows.
2) Key Processes. Implementation of standardized processes is essential to ensure that all members of the care team are working within the same systems to reduce variations in care. Important processes for geriatric surgery include pre-operative risk screening, shared decision-making (SDM) aligned with patient goals, medication management, and proactive multi-disciplinary prevention of post-operative complications like delirium and functional decline.
3) Outcomes, with a focus on Patient Reported Outcome Measures (PROMs). Outcome metrics are necessary to inform the care team, identify gaps, and provide actionable information that can drive quality improvement activities. ACS is a strong advocate for the use of PROMs in the outpatient setting, as described in the following Request for Information (RFI) on Advance Care Planning electronic clinical quality measure (eCQM). Patient reported outcomes (PROs) for Age Friendly Care should focus on patient goals of care, SDM, and function and recovery. Safety and adverse event metrics aligned with procedures are also important elements of quality programs that complement PROs.
5) Peters X, Sage J, Collins C, Opelka F, Ko C. Programmatic quality measures: a new model to promote surgical quality. Health Aff Sch. 2024; 2(1):qxad094.
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Because the quality model in outpatient settings has lagged behind inpatient care, these types of standards and systems still need development. Tracking adverse events and goal attainment aligned with specific procedures and conditions treated in outpatient settings will help inform where there are gaps in the systems of care and where standards and systems must be developed. ACS has years of experience developing and implementing quality programs in our ACS verification and accreditation programs and can be a resource to CMS as they explore ways to advance the quality model for outpatient care.
RFI on the Advance Care Planning eCQM
CMS requests input on the potential inclusion of an Advance Care Planning eCQM and other quality measure concepts related to advance care planning for the Hospital OQR Program. CMS also seeks feedback on whether the Advance Care Planning eCQM is appropriate for use in the hospital outpatient setting, with or without modifications.
ACS supports the use of the Advance Care Planning eCQM in outpatient settings. We also urge CMS to treat the Advance Care Planning measure as the first step in a broader modernization of outpatient quality measurement that is anchored in PROMs and goal-concordance measures equipped to reflect a higher-acuity outpatient population and enable more meaningful quality measurement across settings. From ACS' perspective, advance care planning should be the minimum requirement when striving for patient goal-concordant care.
In this RFI, CMS notes that as more procedures shift from the inpatient to the outpatient setting, there may be repeated opportunities for clinicians to build relationships with patients over time. CMS believes that this could support the initiation or updating of advance care planning documentation. This also presents new opportunities for goals-of-care conversations and SDM. Patient reported measures that incentivize these conversations can capture whether patient goals were discussed and achieved, providing actionable feedback to the care team. This offers an opportunity for CMS to build quality programs for outpatient care around metrics that capture what matters to the patient, in the patient's voice.
ACS sees two potential pathways for CMS to build on the patient-centric goals of the Advance Care Planning measure:
1) SDM and goals of care conversations PROMS, which carry the same patient-centered aim as advance care planning into how decisions are reached with patients. PROMs focused on SDM and goals of care conversations are the on-ramp to more patient-centric care through up-front communication. These conversations between patients and physicians support the development of treatment plans that align with what matters to the patient.
2) PROMs of goal attainment, function, appropriateness, recovery expectations, and adequacy of communication, which capture additional factors of the patient experience during and after care is delivered. These metrics identify outcomes based on the patient's perspective and how well the care team delivered on patient goals.
Both elements are important and necessary to ensure that care teams are assembled around patients and deliver high-quality care based on the patient's needs. Ultimately, these metrics are central to demonstrating the value of outpatient surgical care and offer more comprehensive comparisons of care from the patient's perspective.
Finally, the use of PROMs in outpatient settings is an area of measurement that is currently lacking in patient care and must continue to be prioritized with funding and research. A number of validated instruments already exist on topics of SDM, which carries the aim of advance care planning forward. ACS recommends CMS adopt measures that use tools capture the patient's voice in conversations with their physicians, such as CollaboRATE6 and SDM-9.7 ACS submitted a measure, CollaboRATE Shared Decision-Making Tool for Outpatient or Ambulatory Surgery Patients, for the OQR and ASCQR Programs to assess the quality of patient SDM for surgery in the outpatient and ambulatory setting to improve patient-centricity, patient outcomes, and unnecessary care. However, CMS did not move forward with proposing the measure in this rulemaking cycle. ACS recommends CMS to revisit this measure in the future and invest in the development and testing of additional PROMs that focus on patient goal accordance, patient experience, and functional outcomes suited for surgical patients receiving care in outpatient settings. Because these measures can be applied across all patients and can be agnostic of setting, CMS could implement them in both inpatient and outpatient settings similar to efforts around advance care planning, ultimately creating opportunities for comparative analysis of quality from setting to setting.
RFI ON STRENGTHENING THE STANDARDIZATION AND COMPARABILITY OF HOSPITAL PRICE TRANSPARENCY DATA
ACS supports providing patients and their physicians with clear, accurate, and actionable information on the cost and quality of care to help them make informed decisions about where to seek care. As CMS considers further changes to the Hospital Price Transparency (HPT) requirements, ACS continues to urge the Agency to align these policies with the Transparency in Coverage (TiC) and No Surprises Act (NSA) requirements, avoid duplicative reporting obligations, and focus on information patients can meaningfully use to understand the total cost and value of their care. In addition, cost information should be paired with meaningful quality information reflective of the same care being assessed for cost across an episode of care. ACS offers the following comments on those aspects of the RFI most relevant to surgical patient care.
Machine-Readable Files RFI
CMS seeks information on whether free-text fields, payer and plan names, product and network information, and other machine-readable file (MRF) elements should be further standardized, including additional data elements or unique payer and plan identifiers.
ACS supports greater standardization when it makes information easier to interpret and compare. CMS should, however, first determine whether existing HPT, TiC, and NSA data standards can be aligned or reused before creating new reporting elements. The goal should be a consistent federal approach that reduces complexity and burden rather than adding another parallel set of requirements.
Consumer-Friendly Display Request for Public Comment
ACS supports providing patients with clear and actionable information on the expected cost of care. While individual prices may be useful for relatively simple and predictable services, complex surgical care is better represented through a standardized, clinically informed episode grouper that aggregates the services associated with a procedure and provides patients and their physicians with an expected range of prices based on the procedure, patient characteristics, and insurance coverage. Such a patient- and physician-facing approach should ultimately pair pricing information with meaningful quality information covering the same episode of care.
6 Partnership for Quality Measurement. CollaboRATE Shared Decision-Making Score. Battelle. Accessed August 27, 2026. https://p4qm.org/measures/3227.
7 Harter M, Scholl I. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). University Medical Center Hamburg Eppdendorf. Accessed August 27, 2026. https://www.patient-als-partner.de/media/sdm-q-9_english_version.pdf.
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CMS seeks information on whether it should revise the number or types of CMS-specified shoppable services, including whether services should be added, removed, or updated.
ACS does not recommend expanding the number of required shoppable services. For complex care such as surgery, the usefulness of prices for individual services diminishes because patients often receive multiple related services across clinicians and settings. Rather than expanding a list of individual services, CMS should focus on providing information that reflects the patient's overall course of care through the episode-based approach described above.
CMS seeks information on the advantages and disadvantages of requiring hospitals to submit a shoppable-services file, eliminating deemed compliance for hospitals that use price estimator tools, and the effect those changes could have on consumers' ability to compare hospitals.
ACS does not favor imposing additional requirements for a separate shoppable-services file for hospitals that use price estimator tools. As we have previously stated, TiC and NSA requirements provide patients with more individualized information, and health plans are generally better positioned to calculate a patient's actual cost-sharing liability. CMS should seek greater alignment among these requirements rather than creating additional duplicative hospital reporting obligations.
CMS seeks information on circumstances in which prices shown in a hospital's shoppable-services file or price estimator tool may differ from information for the same items and services in the hospital's MRF, including differences in discounted cash prices.
ACS recognizes that, given the complexity of health insurance contracts, benefit designs, negotiated rates, and patient-specific cost-sharing requirements, some variation across these sources is likely unavoidable. Rather than attempting to eliminate all such variation through additional reporting requirements, CMS should focus on providing patients with information that is meaningful for making care decisions.
For complex care, an episode-based cost-estimation tool could offer a more useful alternative to reliance on a single reported price. Rather than reporting one static rate for a given service, such a tool would bundle the full standardized clinical episode - from preoperative evaluation through the defined post-operative period - and combine a standardized clinical episode with historical utilization and pricing data, as well as patient-specific insurance information. This tool could provide patients and their physicians with a realistic range of expected costs, while accounting for the inherent variability of complex surgical care.
CMS seeks information on which data elements are most important for consumers comparing hospitals, whether a standard shoppable-services template would improve comparability, and how ancillary services included in or excluded from a displayed price should be identified.
ACS supports making reliable, comparable price information available for relatively straightforward services or encounters where the scope of care is predictable and a single service or charge provides patients with meaningful information. For these services, a standardized template that allows patients to readily compare prices across hospitals can be valuable. Health plans should also provide information reflecting patients' specific deductibles, coinsurance, copayments, and other cost-sharing obligations.
For complex procedures and surgical care, however, prices for individual shoppable services provide an incomplete picture of expected costs. CMS should instead use an episode-based approach and clearly identify the professional, facility, ancillary, and other services included or excluded from the expected price range.
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CMS seeks information on how hospitals should present ancillary items, implants, and bundled services so that consumers can better understand total expected costs and distinguish included from excluded services.
For surgical care, ancillary services, implants, and other associated services should be clearly included in estimates, as they make up an important and potentially sizable portion of the total cost experienced by the patient. CMS should move away from presenting complex care as a collection of individual transactions and toward clinically coherent episodes of care. To achieve a more comprehensive view of the cost of surgical care, CMS should instead work with payers, clinical experts, including surgeons, and other stakeholders to establish standardized, clinically informed episode definitions that can support patient- and physician-facing tools.
CMS seeks information on other approaches that could improve the comparability and usefulness of consumer-friendly hospital pricing information.
ACS urges CMS to align HPT requirements with TiC and NSA requirements so that patients receive consistent rather than competing sources of price information. For complex surgical care, CMS should work toward the patient- and physician-facing episode-based approach described above. Using common clinical episode definitions across payers and delivery systems would allow patients and their physicians to make more meaningful comparisons of the expected cost of the full course of care when deciding where to seek treatment.
However, even the best pricing information is incomplete without meaningful information on the quality of the care being purchased. CMS should therefore link episode-based price information with clinically relevant episode-based quality information covering the same care. Presenting price and quality together using a common clinical framework would allow patients and their physicians to best evaluate the value of care options in a way that is not possible using price alone.
Thank you for the opportunity to comment on the CY 2027 OPPS/ASC proposed rule. If you have questions or would like additional information, please contact Vinita Mujumdar, Chief of Regulatory Affairs, at vmujumdar@facs.org or Jill Sage, Chief of Quality Affairs, at jsage@facs.org.
Sincerely,
Patricia L. Turner, MD, MBA, FACS
Executive Director and CEO
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2344-1834
1
August 31, 2026
Mehmet Oz, MD, MBA
Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS-1850-P
P.O. Box 8010
Baltimore, MD 21244-8010
RE:
Hospital Outpatient Prospective Payment and Ambulatory Surgical Center
Payment Systems; and Quality Reporting Programs; including the Hospital
Outpatient Quality Reporting Program and Ambulatory Surgical ... Show Full Article WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. 1 August 31, 2026 Mehmet Oz, MD, MBA Administrator Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-1850-P P.O. Box 8010 Baltimore, MD 21244-8010 RE: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; including the Hospital Outpatient Quality Reporting Program and Ambulatory SurgicalCenter Quality
Program; Request for Information on Strengthening the Standardization and
Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization;
Accrediting Organization (AO) Deeming for Emergency Medical Treatment and
Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and
Opportunities To Apply for Available Slots (CMS-1850-P)
Dear Administrator Oz:
On behalf of the over 95,000 members of the American College of Surgeons (ACS), we appreciate the opportunity to submit comments on the calendar year (CY) 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule published in the Federal Register on July 7, 2026.
ACS is a scientific and educational association of surgeons founded in 1913 to improve the quality of care for the surgical patient by setting high standards for surgical education and practice. Since a large portion of surgical care is furnished in hospital outpatient departments (HOPDs) and ASCs, the College has a vested interest in CMS' coverage, reimbursement, and quality reporting requirements applicable to these settings. With our more than 100-year history in developing policy recommendations to optimize the delivery of surgical services, lower costs, improve program integrity, and make the U.S. healthcare system more effective and accessible, we believe that we can offer insight to the Agency's proposed modifications to the hospital outpatient and ASC payment systems for calendar year (CY) 2027. Our comments below are presented in the order in which they appear in the rule.
PAYMENT AND POLICIES RELATED TO HOSPITAL OUTPATIENT DEPARTMENTS
Proposed Changes to Packaged Items and Services
Implementation of Section 4135 of the Consolidated Appropriations Act, 2023
Section 4135 of the Consolidated Appropriations Act, 2023 (CAA, 2023), commonly referred to as the "NOPAIN Act," requires CMS to make temporary separate payments for qualifying non-opioid treatments furnished from January 1, 2025, through December 31, 2027, rather than package those payments into the associated outpatient service. As a result, CMS proposes to continue providing separate payment for qualifying non-opioid treatments for pain relief furnished in HOPDs and ASCs, consistent with policies finalized as part of CY 2025 and CY 2026 OPPS/ASC rulemaking.
ACS supports CMS' proposal to maintain separate payment for CY 2027. ACS also urges CMS to explore a pathway for continuing separate or additional payment for non-opioid pain management treatments beyond 2027 when the NOPAIN Act provisions expire. As part of this evaluation, CMS should also reconsider the methodology and evidence it uses to determine when separate payment for non-opioid alternatives is warranted, as discussed in greater detail below.
The SUPPORT for Patients and Communities Act provides an important basis for such a review. Section 6082 of the SUPPORT Act added sections 1833(t)(22) and 1833(i)(8) to the Social Security Act (SSA), directing CMS to review OPPS and ASC payments for opioids and evidence-based non-opioid alternatives to ensure that Medicare payment does not create financial incentives favoring opioids over non-opioid alternatives. For the OPPS, section 1833(t)(22) expressly permits CMS to conduct subsequent reviews and directs the Agency to consider whether payment revisions would reduce such incentives. Section 1833(i)(8) directs CMS to conduct a similar review and make appropriate revisions under the ASC payment system.
ACS urges CMS to conduct a subsequent review under these authorities before the NOPAIN Act payment policy expires. In doing so, CMS should use the experience gained under the CY 2025-2027 separate payment policy both to evaluate the need for continued separate payment and to reassess the analytical framework it uses to determine whether packaging creates a financial barrier to non-opioid alternatives.
In prior rulemaking, CMS relied in significant part on Medicare claims data for individual drugs before and after expiration of pass-through payment status to determine whether packaging created a barrier to utilization. ACS has previously expressed concern that this approach is too narrow and may exclude other factors that may be stronger indicators of the accessibility and use of opioid-sparing therapies by physicians and facilities. Changes in utilization following expiration of pass-through status may be informative, but they do not fully capture the range of financial and operational factors that may affect access to non-opioid pain management alternatives.
By the end of CY 2027, CMS will have three years of experience with separate payment for qualifying treatments across both HOPDs and ASCs, providing an opportunity for a more comprehensive assessment than was possible under its earlier analyses. ACS encourages CMS to evaluate a broader range of evidence, including changes in utilization under separate payment; the acquisition costs of non-opioid treatments relative to packaged payments; differences across sites of service and surgical procedures; limitations in claims data for packaged services; and other indicators of beneficiary access. CMS should also seek input from surgeons, facilities, beneficiaries, and other stakeholders regarding whether payment policy affects clinical decision-making, access to non-opioid treatments, or the adoption of opioid-sparing therapies. Allowing the current separate payment policy simply to expire without a comprehensive assessment could recreate the same concerns that prompted Congress to pass the NOPAIN Act.
Accordingly, ACS requests that CMS use the period before expiration of the NOPAIN Act payment policy to evaluate the effects of separate payment, conduct a subsequent review under its existing statutory authority, and identify a pathway for maintaining appropriate payment for evidence-based non-opioid pain management alternatives in CY 2028 and future years.
New Technology APCs
CY 2027 Proposals for SaMS Procedures Currently Assigned to New Technology APCs
CMS observes that software-based technologies with novel functionalities, including artificial intelligence (AI) used to support clinical decision-making, are increasingly used and available to providers. However, a consistent,
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tailored payment pathway is still lacking. CMS notes that it has taken steps to assess and evaluate payment pathways but needs additional data to resolve the underlying valuation challenges. For CY 2027, CMS proposes three changes:
1. Change existing terminology for Software as a Service (SaaS) to Software as a Medical Service (SaMS) to distinguish these technologies from the common commercial meaning of software as a service;
2. Designate 36 Healthcare Common Procedure Coding System (HCPCS) codes as SaMS technologies and, of these, reassign 21 HCPCS codes currently paid separately (status indicator "S") under Clinical Ambulatory Payment Classifications (C-APCs) into New Technology APCs at rates aligned with CY 2026. Codes conditionally packaged (status indicator "Q1") retain their existing C-APC and packaging assignments; and
3. Create a new status indicator "O1" (SaMS, Paid under OPPS, separate APC payment) under OPPS for SaMS. Assign all services proposed to designate as SaMS to status indicator "O1." Status indicator "O1" would have the same payment specifications as status indicator "S," to allow for separate payment.
ACS supports CMS's recognition that a tailored payment pathway for SaMS is needed and that clinical APCs built around material resources do not fit software. To strengthen both interim and future methodologies, ACS recommends that CMS: 1) confirm that SaMS payment is independent of physician work valuations; 2) clarify how procedural and intraoperative AI-based technologies are treated relative to SaMS; 3) extend the SaMS pathway to the ASC setting; and 4) define a data plan and transparent exit criteria for New Technology APC placement.
Clinical Ambulatory Payment Classifications (APCs) group services with comparable clinical characteristics and resource costs and determine payments on this basis. However, the value of SaMS technology lies within a validated algorithm, the data and model development, and its clinical performance. These elements have not historically been captured by the resource assumptions that make up clinical APCs. Forcing software into these groupings does not align with what the service actually contributes and drives the rate variation across comparable technologies that CMS identifies. A dedicated pathway is the necessary first step toward valuing SaMS in a way that aligns with its contributions and generates the consistent data a permanent methodology requires.
As CMS evaluates these pathways and takes steps toward a more permanent solution, ACS asks CMS to explicitly state that separate SaMS payment does not imply reduced physician work and is not evidence of efficiency gains. SaMS technologies are designed to augment, not replace, physicians' clinical judgment. The physician remains responsible for reviewing and interpreting software outputs, appropriately applying outputs to clinical decisions, and communicating with patients. Creating a separate payment for SaMS is not an indication of changes in time, intensity, or complexity of professional work. Therefore, ACS asks CMS to make it clear that SaMS payment is in addition to, and independent of, the valuation of physician work, and that the adoption of these tools will not be misinterpreted as an efficiency adjustment to the corresponding professional service.
In addition, since the HCPCS codes designated for the new technology APCs for 2027 are primarily focused on diagnostic and decision-support systems, ACS asks CMS to define how procedural and intraoperative AI-based technologies relate to SaMS and, if they fall outside that definition, which payment pathway applies. AI is increasingly embedded in the procedural and intraoperative environment. Examples of these tools for surgery are real-time image guidance and navigation, computer-vision, and intraoperative analytics that inform operative decisions. It is unclear from the statements in the proposed rule whether procedural and/or intraoperative AI-based technologies fall within the SaMS definition. Without this clarity, there is risk that these technologies would not be recognized as SaMS or accounted for in other payment pathways, which could ultimately discourage development and uptake in surgical care.
ACS also recommends that CMS establish a parallel SaMS payment pathway in the ASC setting. As CMS continues to phase out the Inpatient Only (IPO) List and expand the ASC covered procedures list, the number of surgical procedures, including complex procedures, in this setting will continue to grow. Without a payment pathway for SaMS in ASC settings, ASCs that adopt the same technology will have no path to payment. Ultimately, this could result in a technology gap that could distort where procedures are performed.
Finally, we ask CMS for a data plan, including how hospitals report subscription and enterprise license costs and transparent exit criteria for New Technology APC placement. New technology APCs are intended to be a temporary placement until sufficient data exists to price a service within the broader APC structure. However, SaMS costs are frequently incurred through subscriptions, enterprise license costs, and per-use or per-click arrangements that do not map cleanly into the current OPPS rate setting process. If these costs are reported inconsistently, it will be difficult to support reliable valuations, which could result in a permanent payment pathway built on flawed data.
SERVICES THAT WILL BE PAID ONLY AS INPATIENT SERVICES
Proposed CY 2027 Changes to IPO List
CMS proposes to continue its policy of eliminating the IPO list, the list that identifies services for which Medicare will make payment only when furnished in the inpatient hospital setting due to the invasive nature of the procedures, the underlying physical condition of the Medicare patient, or the need for at least 24 hours of postoperative recovery time or monitoring before the patient can be safely discharged. CY 2027 will be the second year of the transitional period with the list being completely phased out by CY 2029. The Agency proposes to remove 637 services, or approximately half of the remaining IPO services, from the list for CY 2027, making these services eligible for Medicare payment in the hospital outpatient setting in addition to the inpatient setting.
ACS continues to strongly oppose the elimination of the IPO list. While advances in surgical technique, anesthesia, and perioperative care have allowed certain procedures historically performed on an inpatient basis to be safely furnished in the outpatient setting for carefully selected patients, the continued elimination of the IPO list has implications that extend well beyond whether a procedure technically can be performed on an outpatient basis. These concerns are particularly significant because CMS proposes to remove 637 additional services from the IPO list for CY 2027, including a substantial number of major surgical procedures.
Removal of a procedure from the IPO list does not make the procedure less complex, reduce the resources necessary to perform it, or mean that every patient receiving the procedure can appropriately be treated on an outpatient basis. Nor does removal from the IPO list establish that the existing OPPS APC structure can appropriately accommodate the procedure.
As stated in our previous comments to CMS, we agree with the removal of certain services from the IPO list for which there is evidence that they can safely be furnished in the outpatient setting. However, we are extremely concerned by the Agency's proposed removal of various IPO procedures that do not have sufficient data to support the appropriateness of their performance on an outpatient basis.
Patient Safety, Quality, and Access to Surgical Care
We remain concerned that the elimination of the IPO list makes major and complex procedures that typically require extensive inpatient treatment payable in outpatient sites of service. This policy change raises concerns about safety and quality of care. Even with advancements in medical practice and technology, certain care is too complex to be provided safely in the outpatient setting. Cost and feasibility should not be the only considerations when determining which procedures can be done in outpatient settings. Surgical patients may face more risk in the post-operative period or have comorbidities that require the resources and capabilities of an inpatient setting to prevent or manage complications, including the ability to render timely and necessary interventions to prevent patient death. Evaluating risk with clinical outcomes data to examine pre- and post-operative morbidity and mortality outcomes is critical for making site of service determinations. Analysis of procedures on the IPO list using risk-adjusted clinical data, such as those from ACS National Surgical Quality Improvement Program (NSQIP) registry, can provide insights into safety and appropriateness to determine which procedures can be safely and effectively done in outpatient settings.
Additionally, the next generation of quality measures for the outpatient setting should be patient-centered and tied to the condition(s) and surgical procedure(s) under consideration. They must also track patients across the full episode of care and should not only focus on the care managed within an outpatient setting. Currently, quality mechanisms available for the outpatient setting differ greatly from those in inpatient settings. To date, the majority of efforts to measure quality, especially in surgery, have focused on the inpatient setting. To optimally care for patients in inpatient settings, we have developed capabilities to track outcomes, processes, structures, and patient experience delivered by care teams. This multi-faceted approach to quality is lacking in the outpatient setting, making it difficult to truly understand how complications are managed during and after outpatient procedures, how care teams function, and if care met patient goals. As CMS looks to transition more care to outpatient settings, it is important that it works with clinical experts and relevant specialty societies to build out meaningful and effective quality standards that focus on the patient and equip care teams to deliver optimal care and meet patient goals and expectations.
Out-of-Pocket Costs
We continue to be concerned by the implications that the inevitable mass shift of procedures to the outpatient setting will have on the accessibility and affordability of care for Medicare beneficiaries. Per CMS rules, the copayment for a single outpatient hospital service cannot be more than the inpatient hospital deductible; however, a patient's total copayment for the cumulative cost of all outpatient services related to a single procedure may exceed the inpatient hospital deductible.1
ACS does not support any policies, such as the elimination of the IPO list, which will inappropriately shift costs onto patients and therefore discourage beneficiaries from seeking necessary care.
Medicare Advantage and Commercial Insurer Coverage
Other insurers, including Medicare Advantage Organizations (MAOs), may also use the lack of the IPO list to inappropriately force care into the outpatient setting purely to generate cost-savings for their plans. CMS itself noted that stakeholders have indicated that removing a service from the IPO list creates expectations that the service must be furnished in the outpatient setting "regardless of the clinical judgment of the physician or needs of the patient."2 This policy risks creating an inequitable system in which Medicare Advantage beneficiaries are effectively forced into the outpatient setting for surgical procedures with potentially adverse implications for quality and cost of care. In contrast, beneficiaries enrolled in Original Medicare would continue to have coverage for the same procedure in either the inpatient or outpatient setting based on their clinical needs.3 Peer-reviewed studies have demonstrated that MAOs deny up to 17 percent of initial claims, and one in three Medicare Advantage beneficiaries experience at least one claim denial annually.4 While most of these denials are ultimately overturned on appeal, the appeals process itself delays care and imposes administrative burden on surgical practices. Eliminating the IPO list would significantly heighten the likelihood that MAOs will deny coverage for medically necessary inpatient surgical procedures and only approve outpatient coverage, thereby restricting beneficiary access to the most clinically appropriate site of service.
While we understand CMS is committed to eliminating the IPO list, ACS urges CMS to reconsider the pace of that elimination and to revisit its annual IPO list review process for identifying procedures that should be 1 Centers for Medicare & Medicaid Services. Inpatient or outpatient hospital status affects your costs. Accessed August 20, 2026. https://www.medicare.gov/what-medicare-covers/what-part-a-covers/inpatient-or-outpatient-hospital-status 2 85 Fed. Reg. 48772 (August 12, 2020). 3 Gondi S, Kadakia KT, Tsai TC. Coverage Denials in Medicare Advantage - Balancing Access and Efficiency. JAMA Health Forum. 2024;5(3):e240028. 4 Vabson B, Hicks AL, Chernew ME. Medicare Advantage Denies 17 Percent of Initial Claims; Most Denials Are Reversed, But Provider Payouts Dip 7 Percent. Health Aff (Milwood). 2025;44(6):702-706. 6
added to or removed from the list. That process gives stakeholders an opportunity to provide input and has historically been an effective mechanism for gathering reliable and objective clinician data on the safety and efficacy of procedures furnished in the outpatient setting. In the absence of slowing down the elimination, ACS requests that CMS conduct a study to review the effects of the elimination of the IPO list on patient safety, beneficiary cost-sharing, changes in behavior of MA and private insurance, and patient access to surgical care. High-quality surgical care involves much more than providing services at the lowest possible cost. As noted above, complications can occur with any surgical procedure, particularly during the post-operative period. For many services on the IPO list, such complications will be best identified early and treated promptly in the inpatient hospital setting. We believe that CMS would greatly benefit from coordinating with the surgical community to identify which specific procedures on the existing IPO list may be safely provided in an outpatient setting, instead of simply removing all procedures from the list.
APC-Specific Placements
General Assignment Policy for Procedures Removed from IPO List
As CMS proceeds with the elimination of the IPO list, CMS is required to set payment rates for these procedures in the outpatient setting. This includes assignment to Ambulatory Payment Classifications (APCs) intended to reflect clinical and resource homogeneity of the procedures that are included. ACS does not recommend wholesale restructuring of the OPPS based solely on the former inpatient status of a service. However, there are several examples (inventoried below) of the procedures proposed for CY 2027 that do not fit appropriately within the existing APC structure.
ACS is concerned that for procedures that had previously been performed only in the inpatient setting, CMS' approach to assign these cases to existing APCs could inhibit true clinically appropriate site-of-service selection if the procedure in the outpatient setting is under-resourced. OPPS rate setting is dependent on claims data and cost-to-charge ratios, but CMS does not have any access to this information for these cases in the outpatient setting because they have only been performed in the inpatient setting. We are concerned that the approach to move these formerly-inpatient only procedures into existing APCs in the absence of that data could result in inaccurate payments, potentially even exacerbating concerns about financially-driven hospital or health system site-of-service pressure. While theoretically over time, the system could move toward accurate payment due to CMS' policies for variation in APCs and regulations to reconfigure APCs under the "2 Times Rule," we are concerned the correction will not occur because CMS so often declares exceptions for violations of the "2 Times Rule" due to low volume rather than reconfiguring the affected APC.
In order to avoid these unintended consequences and create data driven APC definitions and assignments, ACS encourages CMS to explore APC creation and assignment for procedures coming off the IPO List modeled after CMS' new technology APCs that more directly address the resources required to provide a service.
This would allow CMS to estimate the outpatient resources needed to deliver a service using available inpatient data, without disturbing or skewing the APC parameters or payment rates for existing APC families. We believe that if these procedures truly can be performed in the outpatient setting, physician-directed, clinically appropriate site of service selection is dependent on the appropriate resourcing of those procedures in each setting, thus removing financial incentives to perform in one site of service over another. These placements in new technology-like APCs with descriptors defined by the reimbursement amount will allow CMS to collect claims and costs data on these procedures if they are performed in the outpatient setting for appropriate APC placement. If they are not, then eventually CMS should address assignment of these procedures via its standing low volume policies.
In the alternative, CMS could restructure the three-year phase-out of the IPO list as a timetable for careful review, not a deadline that requires CMS to remove a service before an appropriate outpatient payment methodology exists. Where additional clinical and resource analysis is necessary, CMS should retain the procedure on the IPO list for CY 2027 and reconsider it in the next phase. Where removal is appropriate, but the proposed APC is not, CMS should revise the APC assignment before finalizing the policy.
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ACS also urges CMS to use the CY 2028 rulemaking process to conduct a more deliberate review of the remaining surgical families and to work with the relevant specialty societies before proposing removal of procedures for which appropriate outpatient clinical comparators and resource data are limited.
ACS Recommendations Regarding Specific CY 2027 IPO Removals and APC Assignments
ACS reviewed a number of the procedures proposed for removal from the IPO list and their corresponding proposed APC assignments. That review reinforces our broader concerns regarding the pace of the IPO phase-out. Several of the proposed assignments do not appear to reflect either the clinical characteristics or expected hospital resources associated with these major surgical procedures.
CMS states that the clinical families selected for CY 2027 generally require less adjustment to existing APCs than the services expected to be addressed in CY 2028. CMS also acknowledges that many of the remaining procedures are more complex and may require a lengthier review process and changes to the current APC structure. ACS believes the same approach should apply to CY 2027 procedures for which the proposed APC assignment demonstrates that additional review is necessary.
CMS should not allow the predetermined schedule for eliminating the IPO list to dictate payment policy. Where CMS cannot identify an existing APC that is clinically and resource homogeneous with a procedure proposed for removal, ACS recommends that CMS retain the procedure on the IPO list for CY 2027 and reconsider it during the CY 2028 phase after CMS has had additional time to evaluate the procedure and, where necessary, restructure or create an appropriate APC.
Where ACS provides an alternative APC recommendation below, that recommendation should not be interpreted as agreement that the procedure is appropriate for removal from the IPO list. For several services, ACS believes continued IPO status is the preferable policy. The alternative APC recommendation addresses the payment that should apply if CMS nevertheless proceeds with removal.
Priority Recommendations
Procedure / CPT Codes
CMS Proposed Assignment
ACS Recommendation
Primary Concern
Necrotizing infection debridement 11004-11006
APC 5053 Level 3 Skin Procedures~$851
Retain on IPO list for CY 2027. If removed, assign to a substantially higher surgical APC. Sepsis, extensive operative debridement, anesthesia, and frequent ICU/step-down needs.
Laparoscopic Heller myotomy 43279
APC 5162 Level 2 ENT Procedures~$599
Retain on IPO list until an appropriate APC is identified; if removed, assign to an appropriate laparoscopic GI APC. Clinical homogeneity problem; abdominal laparoscopic procedure assigned to an ENT APC.
Major open gastric procedures selected 43500-43820
APC 5301 Level 1 Upper GI Procedures~$1,054
Defer the highest-resource procedures to the CY 2028 phase while CMS develops appropriate APC treatment. Major open operations, often requiring laparotomy and multi-day postoperative care.
Open small-bowel resection / reconstruction 44120, 44125, 44130
APC 5303 Level 3 Upper GI Procedures~$4,306
If removed, evaluate APC 5342 or another higher abdominal surgical APC. Resection and reconstruction are more resource intensive than exploration/decompression services in the same APC.
Major open colectomy 44140, 44141, 44143-44147, 44150, 44155, 44160
APC 5341 Level 1 Abdominal/Peritoneal/Biliary~$4,146
If removed, assign to APC 5342 at minimum. Payment hierarchy is difficult to reconcile with routine laparoscopic colectomy in higher-paying APC 5361.
Complex laparoscopic colorectal 44210-44212
APC 5361 Level 1 Laparoscopy~$7,109
If removed, reassign to APC 5362 (~$12,300). Total colectomy/proctocolectomy and pouch-type procedures are not homogeneous with routine laparoscopic cases.
Complex pelvic surgery 45119, 45126, 45136, 45397
APC 5342~$7,715
Retain highest-resource procedures on IPO list while CMS evaluates a higher-level Complex Abdominal/Pelvic C-APC. Existing APC does not adequately distinguish the most extensive pelvic operations, including pelvic exenteration.
Presacral / sacrococcygeal tumor excision 49215
APC 5073 Level 3 Excision/Biopsy/I&D~$3,320
Retain on IPO list until an appropriate APC exists; if removed, APC 5342 at minimum or new complex pelvic APC. Deep pelvic operation is not clinically/resource comparable to routine excision, biopsy, or I&D.
Major hepatic resections including 47120, 47122, 47125, 47130
APC 5341~$4,146
Retain highest-resource resections on IPO list for CY 2027; conduct procedure-level APC review. Major liver resections warrant more granular review than placement in a Level 1 abdominal APC.
Major pancreatic resections 48140, 48145, 48146, 48150, 48152-48155
APC 5341~$4,146
Retain on IPO list for CY 2027 and reconsider during CY 2028 after CMS evaluates appropriate APC structure and resource requirements rather than assigning major pancreatic surgery to a Level 1 abdominal APC simply to maintain the IPO elimination timetable.
Necrotizing Soft-Tissue Infection Debridement - CPT Codes 11004-11006
ACS strongly recommends that CMS retain Current Procedural Terminology (CPT) codes 11004-11006 on the IPO list for CY 2027. These procedures describe extensive operative debridement for necrotizing soft-tissue infection involving the perineum, external genitalia, or abdominal wall. Patients appropriately receiving these services may be septic and may require intensive care unit (ICU) or step-down care.
CMS proposes to assign these services to APC 5053, Level 3 Skin Procedures, with a proposed payment of approximately $851. ACS does not believe this assignment reflects the operative intensity, anesthesia requirements, extent of debridement, or postoperative resources associated with treatment of necrotizing infection.
If CMS nevertheless removes these codes from the IPO list, ACS urges CMS to place them in a substantially higher surgical APC based on the expected resources of the service. At a minimum, CMS should evaluate APC 5073 or another appropriate abdominal/perineal surgical APC rather than treating these procedures as Level 3 skin procedures.
Laparoscopic Heller Myotomy - CPT Code 43279
ACS recommends that CMS reconsider both the removal and proposed APC assignment for CPT code 43279. CMS proposes to assign laparoscopic Heller myotomy to APC 5162, Level 2 ENT Procedures, with a proposed payment of approximately $599. The assignment itself raises an obvious question regarding clinical homogeneity. A laparoscopic Heller myotomy is an abdominal minimally invasive surgical procedure and should not be grouped with Level 2 Otolaryngology (ENT) procedures. ACS recommends that CMS retain CPT code 43279 on the IPO list for CY 2027 unless and until an appropriate OPPS APC is identified. If CMS proceeds with removal, the code should be reassigned to an appropriate laparoscopic gastrointestinal (GI) APC based on clinical and resource similarity.
Major Open Gastric Procedures
ACS has substantial concerns regarding the assignment of numerous major open gastric procedures to APC 5301, Level 1 Upper GI Procedures, with a proposed payment of approximately $1,054. The proposed group includes open gastric repair and resection, partial gastrectomy, pyloroplasty, gastroduodenostomy, and other major open operations.
These procedures may require a large laparotomy and substantial postoperative hospital care. ACS does not believe that assigning the highest-resource major open gastric operations to a Level 1 Upper GI APC appropriately reflects their clinical characteristics or expected resource use.
ACS recommends that CMS retain the highest-resource major open gastric procedures on the IPO list for CY 2027 and reconsider them as part of the CY 2028 phase. This additional time would allow CMS to determine whether an existing higher-level abdominal APC is appropriate or whether additional APC restructuring is necessary.
Major Open Small-Bowel Resection and Reconstruction - CPT Codes 44120, 44125, and 44130
CMS proposes to assign CPT codes 44120, 44125, and 44130 to APC 5303, Level 3 Upper GI Procedures, with a proposed payment of approximately $4,306. APC 5303 may be a reasonable category for certain exploration, adhesiolysis, or decompression services, but intestinal resection and reconstruction are more resource intensive. ACS urges CMS to reassess these services individually. If CMS removes these codes from the IPO list, APC 5342 or another higher-level abdominal surgical APC should be considered based on the expected resource requirements of each procedure.
Major Open Colectomy - CPT Codes 44140, 44141, 44143-44147, 44150, 44155, and 44160
The proposed treatment of open colectomy provides a clear example of an internally inconsistent payment hierarchy. CMS proposes to assign major open colectomy procedures to APC 5341, Level 1 Abdominal/Peritoneal/Biliary and Related Procedures, with a proposed payment of approximately $4,146.
At the same time, routine laparoscopic colectomy procedures are assigned to APC 5361, Level 1 Laparoscopy and Related Services, with a proposed payment of approximately $7,109, while more complex laparoscopic procedures in APC 5362 receive approximately $12,300. ACS does not believe the expected hospital resources associated with major open colectomy are appropriately reflected by a payment hierarchy under which the open procedure is assigned substantially fewer resources than a routine laparoscopic colectomy.
ACS recommends that, if these services are removed from the IPO list, the major open colectomy family be assigned to APC 5342 at minimum rather than APC 5341.
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Complex Laparoscopic Colorectal Surgery - CPT Codes 44210-44212
CMS proposes to assign CPT codes 44210, 44211, and 44212 to APC 5361, Level 1 Laparoscopy and Related Services, with a proposed payment of approximately $7,109. These services include total colectomy, proctocolectomy, and restorative procedures that are considerably more complex than routine laparoscopic colectomy and ostomy services within APC 5361. ACS recommends that CPT codes 44210-44212 be reassigned to APC 5362 if CMS finalizes their removal from the IPO list.
Complex Abdominal and Pelvic Surgery
ACS is particularly concerned that the existing APC structure may not provide an appropriate category for some of the most complex abdominal and pelvic procedures proposed for removal. CMS proposes to assign CPT codes 45119, 45126, 45136, and 45397 to APC 5342, with a proposed payment of approximately $7,715. These procedures include highly complex rectal and pelvic operations. Pelvic exenteration, CPT code 45126, is an especially clear example of a procedure that is not clinically or resource homogeneous with substantially less extensive procedures assigned to the same APC.
ACS recommends that CMS retain the highest-resource complex pelvic procedures on the IPO list for CY 2027 while it evaluates development of a higher-level Complex Abdominal/Pelvic C-APC. CMS should use the CY 2028 rulemaking cycle to propose and seek comment on an appropriate payment structure rather than moving these procedures into an APC that does not adequately reflect their complexity.
Presacral/Sacrococcygeal Tumor Excision - CPT Code 49215
CMS proposes to assign CPT code 49215 to APC 5073, Level 3 Excision/Biopsy/Incision and Drainage, with a proposed payment of approximately $3,320. This is a deep pelvic/presacral operation and is not clinically or resource comparable to routine excision, biopsy, or incision-and-drainage procedures. ACS recommends that CMS retain CPT code 49215 on the IPO list until an appropriate APC is available. If CMS proceeds with removal for CY 2027, ACS recommends assignment to APC 5342 at minimum or inclusion in a new complex pelvic APC.
Major Hepatic Procedures
CMS proposes to assign a number of major open hepatic procedures, including CPT codes 47120, 47122, 47125, and 47130, to APC 5341, with a proposed payment of approximately $4,146.
ACS believes the major hepatic resections warrant procedure-level review before removal from the IPO list. Major hepatic resections should not be moved into the OPPS solely because APC 5341 is the nearest existing abdominal category. CMS should retain the highest-resource hepatic procedures on the IPO list for CY 2027 and evaluate whether APC 5342, a newly structured higher-level abdominal APC, or another payment approach is appropriate.
Major Pancreatic Surgery
ACS has even greater concerns regarding major pancreatic procedures. CMS proposes to assign numerous pancreatic operations, including CPT codes 48140, 48145, 48146, 48150, 48152, 48153, 48154, and 48155, to APC 5341, with a proposed payment of approximately $4,146.
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These services include partial pancreatic resections and other major pancreatic operations. ACS does not believe the proposed assignment demonstrates that these procedures are clinically or resource homogeneous with the other services assigned to APC 5341.
ACS recommends that CMS retain major pancreatic resections on the IPO list for CY 2027 and reconsider their removal during the CY 2028 phase. CMS should use that additional time to evaluate appropriate APC structure and resource requirements rather than assigning major pancreatic surgery to a Level 1 abdominal APC simply to maintain the IPO elimination timetable.
HOSPITAL OUTPATIENT QUALITY REPORTING PROGRAM
The phased elimination of the IPO list represents a significant policy shift that will not only drive more procedures into outpatient and ambulatory settings, but also lead to greater complexity in the procedures performed there. As higher-acuity patients and complex orthopedic, cardiac, and other procedures migrate into hospital outpatient departments, the Hospital Outpatient Quality Reporting (OQR) and Ambulatory Surgery Center Quality Reporting (ASCQR) Programs' measure sets that are designed to evaluate lower-acuity populations may not capture the risks and outcomes that matter most to patients. Because of changes in site of service and patient mix, the CMS OQR and ASCQR programs require a re-evaluation of their quality models. ACS advocates for a programmatic quality framework to assess a broader aspect of clinical care, such as surgery in older adults as one extremely relevant example. Programmatic quality metrics are multifaceted performance metrics that align various measurement strategies to better coordinate quality measurement with frontline care teams. Unlike traditional single measures, such as surgical site infection rates, programmatic measures integrate: structural elements (e.g., staffing, resources, infrastructure), processes (e.g., care delivery steps), and outcomes (e.g., patient goal attainment).5 Together, these measures are designed to be comprehensive and patient-centric, and aligned to reduce the burden of excessive metrics while ensuring that quality goals are realistic and supported by adequate resources. Below, we outline how a programmatic quality model that includes structures, key processes, and outcomes could be designed around geriatric surgery patients in the outpatient setting.
1) Structural Components. ACS advocates for the implementation of key structures, based on evidence that orchestrate high-performing care teams to work within a system that has the right structures and processes in place to deliver on the optimal care pathway. For geriatric surgery, as an example, this might include identified staff roles to support geriatric surgery efforts. These types of systems also give care teams the tools to manage patients when rescue strategies are identified and needed, which may become more prevalent in outpatient settings as complexity grows.
2) Key Processes. Implementation of standardized processes is essential to ensure that all members of the care team are working within the same systems to reduce variations in care. Important processes for geriatric surgery include pre-operative risk screening, shared decision-making (SDM) aligned with patient goals, medication management, and proactive multi-disciplinary prevention of post-operative complications like delirium and functional decline.
3) Outcomes, with a focus on Patient Reported Outcome Measures (PROMs). Outcome metrics are necessary to inform the care team, identify gaps, and provide actionable information that can drive quality improvement activities. ACS is a strong advocate for the use of PROMs in the outpatient setting, as described in the following Request for Information (RFI) on Advance Care Planning electronic clinical quality measure (eCQM). Patient reported outcomes (PROs) for Age Friendly Care should focus on patient goals of care, SDM, and function and recovery. Safety and adverse event metrics aligned with procedures are also important elements of quality programs that complement PROs.
5) Peters X, Sage J, Collins C, Opelka F, Ko C. Programmatic quality measures: a new model to promote surgical quality. Health Aff Sch. 2024; 2(1):qxad094.
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Because the quality model in outpatient settings has lagged behind inpatient care, these types of standards and systems still need development. Tracking adverse events and goal attainment aligned with specific procedures and conditions treated in outpatient settings will help inform where there are gaps in the systems of care and where standards and systems must be developed. ACS has years of experience developing and implementing quality programs in our ACS verification and accreditation programs and can be a resource to CMS as they explore ways to advance the quality model for outpatient care.
RFI on the Advance Care Planning eCQM
CMS requests input on the potential inclusion of an Advance Care Planning eCQM and other quality measure concepts related to advance care planning for the Hospital OQR Program. CMS also seeks feedback on whether the Advance Care Planning eCQM is appropriate for use in the hospital outpatient setting, with or without modifications.
ACS supports the use of the Advance Care Planning eCQM in outpatient settings. We also urge CMS to treat the Advance Care Planning measure as the first step in a broader modernization of outpatient quality measurement that is anchored in PROMs and goal-concordance measures equipped to reflect a higher-acuity outpatient population and enable more meaningful quality measurement across settings. From ACS' perspective, advance care planning should be the minimum requirement when striving for patient goal-concordant care.
In this RFI, CMS notes that as more procedures shift from the inpatient to the outpatient setting, there may be repeated opportunities for clinicians to build relationships with patients over time. CMS believes that this could support the initiation or updating of advance care planning documentation. This also presents new opportunities for goals-of-care conversations and SDM. Patient reported measures that incentivize these conversations can capture whether patient goals were discussed and achieved, providing actionable feedback to the care team. This offers an opportunity for CMS to build quality programs for outpatient care around metrics that capture what matters to the patient, in the patient's voice.
ACS sees two potential pathways for CMS to build on the patient-centric goals of the Advance Care Planning measure:
1) SDM and goals of care conversations PROMS, which carry the same patient-centered aim as advance care planning into how decisions are reached with patients. PROMs focused on SDM and goals of care conversations are the on-ramp to more patient-centric care through up-front communication. These conversations between patients and physicians support the development of treatment plans that align with what matters to the patient.
2) PROMs of goal attainment, function, appropriateness, recovery expectations, and adequacy of communication, which capture additional factors of the patient experience during and after care is delivered. These metrics identify outcomes based on the patient's perspective and how well the care team delivered on patient goals.
Both elements are important and necessary to ensure that care teams are assembled around patients and deliver high-quality care based on the patient's needs. Ultimately, these metrics are central to demonstrating the value of outpatient surgical care and offer more comprehensive comparisons of care from the patient's perspective.
Finally, the use of PROMs in outpatient settings is an area of measurement that is currently lacking in patient care and must continue to be prioritized with funding and research. A number of validated instruments already exist on topics of SDM, which carries the aim of advance care planning forward. ACS recommends CMS adopt measures that use tools capture the patient's voice in conversations with their physicians, such as CollaboRATE6 and SDM-9.7 ACS submitted a measure, CollaboRATE Shared Decision-Making Tool for Outpatient or Ambulatory Surgery Patients, for the OQR and ASCQR Programs to assess the quality of patient SDM for surgery in the outpatient and ambulatory setting to improve patient-centricity, patient outcomes, and unnecessary care. However, CMS did not move forward with proposing the measure in this rulemaking cycle. ACS recommends CMS to revisit this measure in the future and invest in the development and testing of additional PROMs that focus on patient goal accordance, patient experience, and functional outcomes suited for surgical patients receiving care in outpatient settings. Because these measures can be applied across all patients and can be agnostic of setting, CMS could implement them in both inpatient and outpatient settings similar to efforts around advance care planning, ultimately creating opportunities for comparative analysis of quality from setting to setting.
RFI ON STRENGTHENING THE STANDARDIZATION AND COMPARABILITY OF HOSPITAL PRICE TRANSPARENCY DATA
ACS supports providing patients and their physicians with clear, accurate, and actionable information on the cost and quality of care to help them make informed decisions about where to seek care. As CMS considers further changes to the Hospital Price Transparency (HPT) requirements, ACS continues to urge the Agency to align these policies with the Transparency in Coverage (TiC) and No Surprises Act (NSA) requirements, avoid duplicative reporting obligations, and focus on information patients can meaningfully use to understand the total cost and value of their care. In addition, cost information should be paired with meaningful quality information reflective of the same care being assessed for cost across an episode of care. ACS offers the following comments on those aspects of the RFI most relevant to surgical patient care.
Machine-Readable Files RFI
CMS seeks information on whether free-text fields, payer and plan names, product and network information, and other machine-readable file (MRF) elements should be further standardized, including additional data elements or unique payer and plan identifiers.
ACS supports greater standardization when it makes information easier to interpret and compare. CMS should, however, first determine whether existing HPT, TiC, and NSA data standards can be aligned or reused before creating new reporting elements. The goal should be a consistent federal approach that reduces complexity and burden rather than adding another parallel set of requirements.
Consumer-Friendly Display Request for Public Comment
ACS supports providing patients with clear and actionable information on the expected cost of care. While individual prices may be useful for relatively simple and predictable services, complex surgical care is better represented through a standardized, clinically informed episode grouper that aggregates the services associated with a procedure and provides patients and their physicians with an expected range of prices based on the procedure, patient characteristics, and insurance coverage. Such a patient- and physician-facing approach should ultimately pair pricing information with meaningful quality information covering the same episode of care.
6 Partnership for Quality Measurement. CollaboRATE Shared Decision-Making Score. Battelle. Accessed August 27, 2026. https://p4qm.org/measures/3227.
7 Harter M, Scholl I. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). University Medical Center Hamburg Eppdendorf. Accessed August 27, 2026. https://www.patient-als-partner.de/media/sdm-q-9_english_version.pdf.
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CMS seeks information on whether it should revise the number or types of CMS-specified shoppable services, including whether services should be added, removed, or updated.
ACS does not recommend expanding the number of required shoppable services. For complex care such as surgery, the usefulness of prices for individual services diminishes because patients often receive multiple related services across clinicians and settings. Rather than expanding a list of individual services, CMS should focus on providing information that reflects the patient's overall course of care through the episode-based approach described above.
CMS seeks information on the advantages and disadvantages of requiring hospitals to submit a shoppable-services file, eliminating deemed compliance for hospitals that use price estimator tools, and the effect those changes could have on consumers' ability to compare hospitals.
ACS does not favor imposing additional requirements for a separate shoppable-services file for hospitals that use price estimator tools. As we have previously stated, TiC and NSA requirements provide patients with more individualized information, and health plans are generally better positioned to calculate a patient's actual cost-sharing liability. CMS should seek greater alignment among these requirements rather than creating additional duplicative hospital reporting obligations.
CMS seeks information on circumstances in which prices shown in a hospital's shoppable-services file or price estimator tool may differ from information for the same items and services in the hospital's MRF, including differences in discounted cash prices.
ACS recognizes that, given the complexity of health insurance contracts, benefit designs, negotiated rates, and patient-specific cost-sharing requirements, some variation across these sources is likely unavoidable. Rather than attempting to eliminate all such variation through additional reporting requirements, CMS should focus on providing patients with information that is meaningful for making care decisions.
For complex care, an episode-based cost-estimation tool could offer a more useful alternative to reliance on a single reported price. Rather than reporting one static rate for a given service, such a tool would bundle the full standardized clinical episode - from preoperative evaluation through the defined post-operative period - and combine a standardized clinical episode with historical utilization and pricing data, as well as patient-specific insurance information. This tool could provide patients and their physicians with a realistic range of expected costs, while accounting for the inherent variability of complex surgical care.
CMS seeks information on which data elements are most important for consumers comparing hospitals, whether a standard shoppable-services template would improve comparability, and how ancillary services included in or excluded from a displayed price should be identified.
ACS supports making reliable, comparable price information available for relatively straightforward services or encounters where the scope of care is predictable and a single service or charge provides patients with meaningful information. For these services, a standardized template that allows patients to readily compare prices across hospitals can be valuable. Health plans should also provide information reflecting patients' specific deductibles, coinsurance, copayments, and other cost-sharing obligations.
For complex procedures and surgical care, however, prices for individual shoppable services provide an incomplete picture of expected costs. CMS should instead use an episode-based approach and clearly identify the professional, facility, ancillary, and other services included or excluded from the expected price range.
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CMS seeks information on how hospitals should present ancillary items, implants, and bundled services so that consumers can better understand total expected costs and distinguish included from excluded services.
For surgical care, ancillary services, implants, and other associated services should be clearly included in estimates, as they make up an important and potentially sizable portion of the total cost experienced by the patient. CMS should move away from presenting complex care as a collection of individual transactions and toward clinically coherent episodes of care. To achieve a more comprehensive view of the cost of surgical care, CMS should instead work with payers, clinical experts, including surgeons, and other stakeholders to establish standardized, clinically informed episode definitions that can support patient- and physician-facing tools.
CMS seeks information on other approaches that could improve the comparability and usefulness of consumer-friendly hospital pricing information.
ACS urges CMS to align HPT requirements with TiC and NSA requirements so that patients receive consistent rather than competing sources of price information. For complex surgical care, CMS should work toward the patient- and physician-facing episode-based approach described above. Using common clinical episode definitions across payers and delivery systems would allow patients and their physicians to make more meaningful comparisons of the expected cost of the full course of care when deciding where to seek treatment.
However, even the best pricing information is incomplete without meaningful information on the quality of the care being purchased. CMS should therefore link episode-based price information with clinically relevant episode-based quality information covering the same care. Presenting price and quality together using a common clinical framework would allow patients and their physicians to best evaluate the value of care options in a way that is not possible using price alone.
Thank you for the opportunity to comment on the CY 2027 OPPS/ASC proposed rule. If you have questions or would like additional information, please contact Vinita Mujumdar, Chief of Regulatory Affairs, at vmujumdar@facs.org or Jill Sage, Chief of Quality Affairs, at jsage@facs.org.
Sincerely,
Patricia L. Turner, MD, MBA, FACS
Executive Director and CEO
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2344-1834
American Benefits Council Urges CMS to Enact Site-Neutral Payment Cuts for Imaging Without Contrast
Carter Struck
WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
August 31, 2026
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1850-P
P.O. Box 8010
Baltimore, MD 21244-8010
RE: Comments in Response to Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality ... Show Full Article WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 31, 2026 Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1850-P P.O. Box 8010 Baltimore, MD 21244-8010 RE: Comments in Response to Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center QualityProgram; Request for Information on Strengthening the Standardization and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities
To Apply for Available Slots (CMS-1850-P)
Dear Sir or Madam,
I write on behalf of the American Benefits Council ("the Council") to provide comments on the Centers for Medicare & Medicaid Services' (CMS) Calendar Year 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule ("proposed regulations") published in the Federal Register on July 7, 2026 (CMS-1850-P). The Council has long been a leader in supporting high value health care and changes to remove payment incentives that drive medically unnecessary site-of-service decision-making. We take this opportunity to comment specifically on the proposed regulation's site-neutral payment reforms.
The Council is a national non-profit organization dedicated to protecting employer sponsored benefit plans. The Council represents more major employers--over 220 of the world's largest corporations--than any other association that exclusively advocates on the full range of employee benefit issues. Members also include organizations supporting employers of all sizes. Collectively, Council members directly sponsor or support health and retirement plans covering virtually all Americans participating in 2
employer-sponsored programs.
Providing health coverage to more than 181 million Americans,1
employers play a
critical role in the health care system and drive innovations from which the entire health system benefits. With a vested interest in securing the health and well-being of their employees, employers deliver high-value, innovative health coverage to workers and their families. However, employers are deeply concerned about rising health care costs.
Rising health care prices are placing an increasingly large burden on American employers and workers. According to a survey by the Kaiser Family Foundation, annual premiums for employer-sponsored health coverage reached $26,993 in 2025, an increase of almost 6% from the prior year, with workers, on average, paying $6,850 toward that cost.
2
Employers are bracing for even higher costs this year.3
This
trajectory is unsustainable for employers, employees and their families. As we approach 2027, employers are looking at new ways to structure their health plans to help curb some of these increases in costs.4
The only way to make health care truly more affordable for employers and working families is to understand and address the root causes of rising spending, including misaligned incentives that promote hospital and provider consolidation and higher-cost care. While employers continue their efforts to lower health care costs, federal solutions are needed to create a more competitive, transparent health care marketplace and remove payment distortions that drive higher-cost care.
SITE-NEUTRAL PAYMENT REFORM
The Council has long advocated for site-neutral payment reform as a means of lowering health care costs and improving competition. The Council strongly supports CMS' proposal to extend site-neutral payment reform to imaging without contrast services furnished in excepted off-campus provider-based departments (PBDs).
Hospital costs account for 44% of total personal health care spending for the privately insured, and hospital price increases are key drivers of recent growth in per capita spending among these individuals.5
This spending is being fueled by hospital
1 U.S. Census Bureau, Health Insurance Coverage in the United States: 2024 (September 2025).
2 Kaiser Family Foundation, 2025 Employer Health Benefits Survey (October 22, 2025).
3 Mercer, "Employers prepare for the highest health benefit cost increase in 15 years" (September 3, 2025).
4 Mercer, "Employers are shifting health care costs to employees but also leveraging new approaches to minimize impact" (June 11, 2026).
5 Rand Corporation, Nationwide Evaluation of Health Care Prices Paid by Private Health Plans (2020).
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consolidation and vertical integration with physician practices that leads to higher health care costs without an increase in quality.6 After hospitals purchase physician practices, they are able to rename the practices as "hospital facilities" and thereby bill at higher hospital rates (that now include a "facility" fee for the exact same service). This payment distortion encourages provider consolidation without any corresponding increase in quality of care, and in turn, fuels higher costs. Reducing payment disparities across care settings can better align incentives with value, curb consolidation, and lower costs for patients, employers, and taxpayers.
Medicare's site-neutral payment policy aligns rates for certain services that can be safely furnished in hospital outpatient departments (HOPDs), ASCs, or freestanding physician offices. By reducing payment differences across settings, the policy seeks to eliminate incentives that may increase costs, reduce quality, or create inefficiencies. In 2012, the Medicare Payment Advisory Commission (MedPAC) recommended aligning payment rates for certain evaluation and management services furnished in physician offices and HOPDs. In 2015, MedPAC extended its recommendations to comparable care furnished in inpatient rehabilitation facilities and skilled nursing facilities.
For calendar year (CY) 2027, CMS proposes applying the Physician Fee Scheduleequivalent payment rate to imaging without contrast services furnished in excepted offcampus PBDs. Using its authority under section 1833(t)(2)(F) of the Social Security Act, CMS proposes to apply the Physician Fee Schedule-equivalent payment rate to HCPCS codes assigned to the relevant ambulatory payment classifications when services are furnished in off-campus PBDs excepted from section 603 of the Bipartisan Budget Act of 2015. In analyzing the situation, CMS examined the growth in imaging without contrast services furnished in excepted PBDs. CMS considers imaging without contrast services to include diagnostic imaging procedures that do not require the administration of contrast agents and instead rely on standard imaging modalities such as X-ray, ultrasound, computed tomography, magnetic resonance imaging, and dual-energy Xray absorptiometry (DXA) scans to produce clinically meaningful images. These generally low- to moderate-complexity services are routinely used to evaluate musculoskeletal injuries, organ structure, and disease and can be furnished safely and effectively in physician offices and HOPDs without compromising diagnostic quality or patient safety.
The Council strongly supports the proposal and applauds CMS for building on prior site-neutral payment reforms, including its CY 2026 extension of the policy to drug administration services. Applying site-neutral rates to imaging without contrast is a commonsense next step that would reduce beneficiary out-of-pocket costs and overall 6 Cory Capps, David Dranove and Christopher Ody, "The effect of hospital acquisitions of physician practices on prices and spending," Journal of Health Economics (May 2018); The Hamilton Project, A Proposal to Cap Provider Prices and Price Growth in the Commercial Health-Care Market, pp. 7 (March 2020).
4
spending by federal and private payers (who often pay providers based on multiples of the Medicare payment rate). It discourages furnishing services in excepted off-campus PBDs when beneficiaries can safely receive the necessary care in lower-cost settings.
CMS found that the volume of these procedures, which are overwhelmingly
furnished in excepted PBDs, increased by more than 38% from 2016 to 2025. Over the same period, spending rose 33%, resulting in approximately $126 million in additional CY 2025 spending. CMS attributes much of this growth to financial incentives to furnish low-complexity imaging in HOPDs rather than physician offices.7
The Council agrees
that the proposal, if finalized, will help curb unnecessary volume growth in imaging without contrast services at excepted PBDs.
Consistent with its existing volume-control policies for off-campus clinic visits and drug administration services, CMS proposes to exempt rural Sole Community
Hospitals. The Council supports CMS in finding ways to ameliorate the possible negative effect of these changes on rural and underserved communities. Site-neutral policies should preserve access in communities with limited care options and avoid adverse effects on genuinely rural providers, while remaining sufficiently targeted to deter consolidation and unnecessary use of higher-cost settings.
CMS estimates that the provision would reduce first-year Medicare Part B
expenditures by approximately $260 million, consisting of approximately $190 million in Part B savings and $70 million in lower beneficiary premiums. Beneficiary costsharing obligations would also decline by approximately $70 million.8 These savings
would directly improve affordability for Medicare beneficiaries by reducing payment differences based solely on the site of care. Finalizing the proposal could also produce spillover savings in the commercial market because many commercial rates are benchmarked to Medicare payment.
The Council notes that this proposal is important to employer plan sponsors.
Payment policies favoring HOPDs increase costs not only for individuals enrolled in Medicare, but also for participants in employer-sponsored plans because commercial payers often use Medicare reimbursement standards to inform private rates. Narrowing unwarranted payment differences among sites of care can reduce consolidation incentives, promote competition, and lower health care costs. Indeed, a recent study found that the proposed change would save commercial payors and their enrollees and their families $2.5 billion dollars over ten years.9
7 91 FR 41734 https://www.federalregister.gov/d/2026-13656/p-1211.
8 91 FR 41734 https://www.federalregister.gov/d/2026-13656/p-1267.
9 Tony Mader and Scott Allen, Savings Estimates for CMS' Imaging Without Contrast Site-Neutral Payment Proposal (August 24, 2026).
5
The Council continues to encourage CMS to expand and strengthen site-neutral payment policies beyond excepted off-campus PBDs where clinically appropriate. CMS should evaluate services furnished in other ambulatory settings--including on-campus PBDs, ASCs, and emergency departments--and promptly pursue reforms for services that can be safely delivered in lower-cost settings. Any expansion should retain carefully tailored protections for rural access.
Finally, the Council recognizes that broader legislative action is needed to make health care more affordable for employers and working families. The Council has urged Congress and CMS to expand site-neutral payment reform while avoiding unintended cost shifts to plan sponsors. Paying different rates for the same or similar outpatient services furnished in HOPDs, ASCs, and physician offices encourages consolidation and steers care toward higher-cost settings. Eliminating those incentives is essential to increasing competition, improving value, and lowering costs without undermining employers' cost-control efforts. More generally, the Council continues to encourage policymakers to adopt measures that lower health care costs and improve value while balancing the costs and burdens imposed on employer-sponsored health plans and avoiding interference with employers' efforts to lower health care costs.
CODIFICATION OF SECTION 6225 OF THE CONSOLIDATED APPROPRIATIONS ACT, 2026
(CAA, 2026) FOR THE REQUIREMENTS FOR PROVIDER BASED STATUS
Section 6225 of the CAA, 2026 will prohibit Medicare payments under the OPPS beginning January 1, 2028, unless off-campus outpatient departments of a provider bill using a separate National Provider Identifier (NPI) and the main provider (i.e. the oncampus hospital system) has submitted an attestation meeting the requirements for being a provider-based department. The Council strongly supported this provision and seeks to ensure its strong implementation.
As large hospital systems purchase physician practices, they have been able to portray services delivered at these sites as "hospital services" as opposed to "professional services" to receive the higher facility reimbursement fee. Hospitals have leveraged the acquisition of physician practices to bill payers -- including employersponsored group health plans -- higher rates by portraying non-hospital-based professional services as if they were delivered in a hospital. This opaque billing practice has incentivized vertical hospital-physician consolidation and increased costs for employers and patients.
Requiring hospitals to specify where services are provided when they bill will allow payors to distinguish between services performed at the main hospital versus those performed at a physician's office acquired by the hospital and subsequently billed as hospital outpatient care for which higher reimbursement rates apply. The Council believes that strong implementation of the statutory provision will allow payors to 6
distinguish between sites of service to apply the appropriate payment, and the Council urges lawmakers to expand this billing transparency requirement to the commercial market as well.
* * * * *
Thank you for the opportunity to comment on this proposed regulation.
If you have any questions or would like to discuss these recommendations further, please contact us at (202) 289-6700.
Sincerely,
Matt Muma
Senior Counsel, Health Policy
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2344-1581
August 31, 2026
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1850-P
P.O. Box 8010
Baltimore, MD 21244-8010
RE: Comments in Response to Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality ... Show Full Article WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 31, 2026 Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1850-P P.O. Box 8010 Baltimore, MD 21244-8010 RE: Comments in Response to Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center QualityProgram; Request for Information on Strengthening the Standardization and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities
To Apply for Available Slots (CMS-1850-P)
Dear Sir or Madam,
I write on behalf of the American Benefits Council ("the Council") to provide comments on the Centers for Medicare & Medicaid Services' (CMS) Calendar Year 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Proposed Rule ("proposed regulations") published in the Federal Register on July 7, 2026 (CMS-1850-P). The Council has long been a leader in supporting high value health care and changes to remove payment incentives that drive medically unnecessary site-of-service decision-making. We take this opportunity to comment specifically on the proposed regulation's site-neutral payment reforms.
The Council is a national non-profit organization dedicated to protecting employer sponsored benefit plans. The Council represents more major employers--over 220 of the world's largest corporations--than any other association that exclusively advocates on the full range of employee benefit issues. Members also include organizations supporting employers of all sizes. Collectively, Council members directly sponsor or support health and retirement plans covering virtually all Americans participating in 2
employer-sponsored programs.
Providing health coverage to more than 181 million Americans,1
employers play a
critical role in the health care system and drive innovations from which the entire health system benefits. With a vested interest in securing the health and well-being of their employees, employers deliver high-value, innovative health coverage to workers and their families. However, employers are deeply concerned about rising health care costs.
Rising health care prices are placing an increasingly large burden on American employers and workers. According to a survey by the Kaiser Family Foundation, annual premiums for employer-sponsored health coverage reached $26,993 in 2025, an increase of almost 6% from the prior year, with workers, on average, paying $6,850 toward that cost.
2
Employers are bracing for even higher costs this year.3
This
trajectory is unsustainable for employers, employees and their families. As we approach 2027, employers are looking at new ways to structure their health plans to help curb some of these increases in costs.4
The only way to make health care truly more affordable for employers and working families is to understand and address the root causes of rising spending, including misaligned incentives that promote hospital and provider consolidation and higher-cost care. While employers continue their efforts to lower health care costs, federal solutions are needed to create a more competitive, transparent health care marketplace and remove payment distortions that drive higher-cost care.
SITE-NEUTRAL PAYMENT REFORM
The Council has long advocated for site-neutral payment reform as a means of lowering health care costs and improving competition. The Council strongly supports CMS' proposal to extend site-neutral payment reform to imaging without contrast services furnished in excepted off-campus provider-based departments (PBDs).
Hospital costs account for 44% of total personal health care spending for the privately insured, and hospital price increases are key drivers of recent growth in per capita spending among these individuals.5
This spending is being fueled by hospital
1 U.S. Census Bureau, Health Insurance Coverage in the United States: 2024 (September 2025).
2 Kaiser Family Foundation, 2025 Employer Health Benefits Survey (October 22, 2025).
3 Mercer, "Employers prepare for the highest health benefit cost increase in 15 years" (September 3, 2025).
4 Mercer, "Employers are shifting health care costs to employees but also leveraging new approaches to minimize impact" (June 11, 2026).
5 Rand Corporation, Nationwide Evaluation of Health Care Prices Paid by Private Health Plans (2020).
3
consolidation and vertical integration with physician practices that leads to higher health care costs without an increase in quality.6 After hospitals purchase physician practices, they are able to rename the practices as "hospital facilities" and thereby bill at higher hospital rates (that now include a "facility" fee for the exact same service). This payment distortion encourages provider consolidation without any corresponding increase in quality of care, and in turn, fuels higher costs. Reducing payment disparities across care settings can better align incentives with value, curb consolidation, and lower costs for patients, employers, and taxpayers.
Medicare's site-neutral payment policy aligns rates for certain services that can be safely furnished in hospital outpatient departments (HOPDs), ASCs, or freestanding physician offices. By reducing payment differences across settings, the policy seeks to eliminate incentives that may increase costs, reduce quality, or create inefficiencies. In 2012, the Medicare Payment Advisory Commission (MedPAC) recommended aligning payment rates for certain evaluation and management services furnished in physician offices and HOPDs. In 2015, MedPAC extended its recommendations to comparable care furnished in inpatient rehabilitation facilities and skilled nursing facilities.
For calendar year (CY) 2027, CMS proposes applying the Physician Fee Scheduleequivalent payment rate to imaging without contrast services furnished in excepted offcampus PBDs. Using its authority under section 1833(t)(2)(F) of the Social Security Act, CMS proposes to apply the Physician Fee Schedule-equivalent payment rate to HCPCS codes assigned to the relevant ambulatory payment classifications when services are furnished in off-campus PBDs excepted from section 603 of the Bipartisan Budget Act of 2015. In analyzing the situation, CMS examined the growth in imaging without contrast services furnished in excepted PBDs. CMS considers imaging without contrast services to include diagnostic imaging procedures that do not require the administration of contrast agents and instead rely on standard imaging modalities such as X-ray, ultrasound, computed tomography, magnetic resonance imaging, and dual-energy Xray absorptiometry (DXA) scans to produce clinically meaningful images. These generally low- to moderate-complexity services are routinely used to evaluate musculoskeletal injuries, organ structure, and disease and can be furnished safely and effectively in physician offices and HOPDs without compromising diagnostic quality or patient safety.
The Council strongly supports the proposal and applauds CMS for building on prior site-neutral payment reforms, including its CY 2026 extension of the policy to drug administration services. Applying site-neutral rates to imaging without contrast is a commonsense next step that would reduce beneficiary out-of-pocket costs and overall 6 Cory Capps, David Dranove and Christopher Ody, "The effect of hospital acquisitions of physician practices on prices and spending," Journal of Health Economics (May 2018); The Hamilton Project, A Proposal to Cap Provider Prices and Price Growth in the Commercial Health-Care Market, pp. 7 (March 2020).
4
spending by federal and private payers (who often pay providers based on multiples of the Medicare payment rate). It discourages furnishing services in excepted off-campus PBDs when beneficiaries can safely receive the necessary care in lower-cost settings.
CMS found that the volume of these procedures, which are overwhelmingly
furnished in excepted PBDs, increased by more than 38% from 2016 to 2025. Over the same period, spending rose 33%, resulting in approximately $126 million in additional CY 2025 spending. CMS attributes much of this growth to financial incentives to furnish low-complexity imaging in HOPDs rather than physician offices.7
The Council agrees
that the proposal, if finalized, will help curb unnecessary volume growth in imaging without contrast services at excepted PBDs.
Consistent with its existing volume-control policies for off-campus clinic visits and drug administration services, CMS proposes to exempt rural Sole Community
Hospitals. The Council supports CMS in finding ways to ameliorate the possible negative effect of these changes on rural and underserved communities. Site-neutral policies should preserve access in communities with limited care options and avoid adverse effects on genuinely rural providers, while remaining sufficiently targeted to deter consolidation and unnecessary use of higher-cost settings.
CMS estimates that the provision would reduce first-year Medicare Part B
expenditures by approximately $260 million, consisting of approximately $190 million in Part B savings and $70 million in lower beneficiary premiums. Beneficiary costsharing obligations would also decline by approximately $70 million.8 These savings
would directly improve affordability for Medicare beneficiaries by reducing payment differences based solely on the site of care. Finalizing the proposal could also produce spillover savings in the commercial market because many commercial rates are benchmarked to Medicare payment.
The Council notes that this proposal is important to employer plan sponsors.
Payment policies favoring HOPDs increase costs not only for individuals enrolled in Medicare, but also for participants in employer-sponsored plans because commercial payers often use Medicare reimbursement standards to inform private rates. Narrowing unwarranted payment differences among sites of care can reduce consolidation incentives, promote competition, and lower health care costs. Indeed, a recent study found that the proposed change would save commercial payors and their enrollees and their families $2.5 billion dollars over ten years.9
7 91 FR 41734 https://www.federalregister.gov/d/2026-13656/p-1211.
8 91 FR 41734 https://www.federalregister.gov/d/2026-13656/p-1267.
9 Tony Mader and Scott Allen, Savings Estimates for CMS' Imaging Without Contrast Site-Neutral Payment Proposal (August 24, 2026).
5
The Council continues to encourage CMS to expand and strengthen site-neutral payment policies beyond excepted off-campus PBDs where clinically appropriate. CMS should evaluate services furnished in other ambulatory settings--including on-campus PBDs, ASCs, and emergency departments--and promptly pursue reforms for services that can be safely delivered in lower-cost settings. Any expansion should retain carefully tailored protections for rural access.
Finally, the Council recognizes that broader legislative action is needed to make health care more affordable for employers and working families. The Council has urged Congress and CMS to expand site-neutral payment reform while avoiding unintended cost shifts to plan sponsors. Paying different rates for the same or similar outpatient services furnished in HOPDs, ASCs, and physician offices encourages consolidation and steers care toward higher-cost settings. Eliminating those incentives is essential to increasing competition, improving value, and lowering costs without undermining employers' cost-control efforts. More generally, the Council continues to encourage policymakers to adopt measures that lower health care costs and improve value while balancing the costs and burdens imposed on employer-sponsored health plans and avoiding interference with employers' efforts to lower health care costs.
CODIFICATION OF SECTION 6225 OF THE CONSOLIDATED APPROPRIATIONS ACT, 2026
(CAA, 2026) FOR THE REQUIREMENTS FOR PROVIDER BASED STATUS
Section 6225 of the CAA, 2026 will prohibit Medicare payments under the OPPS beginning January 1, 2028, unless off-campus outpatient departments of a provider bill using a separate National Provider Identifier (NPI) and the main provider (i.e. the oncampus hospital system) has submitted an attestation meeting the requirements for being a provider-based department. The Council strongly supported this provision and seeks to ensure its strong implementation.
As large hospital systems purchase physician practices, they have been able to portray services delivered at these sites as "hospital services" as opposed to "professional services" to receive the higher facility reimbursement fee. Hospitals have leveraged the acquisition of physician practices to bill payers -- including employersponsored group health plans -- higher rates by portraying non-hospital-based professional services as if they were delivered in a hospital. This opaque billing practice has incentivized vertical hospital-physician consolidation and increased costs for employers and patients.
Requiring hospitals to specify where services are provided when they bill will allow payors to distinguish between services performed at the main hospital versus those performed at a physician's office acquired by the hospital and subsequently billed as hospital outpatient care for which higher reimbursement rates apply. The Council believes that strong implementation of the statutory provision will allow payors to 6
distinguish between sites of service to apply the appropriate payment, and the Council urges lawmakers to expand this billing transparency requirement to the commercial market as well.
* * * * *
Thank you for the opportunity to comment on this proposed regulation.
If you have any questions or would like to discuss these recommendations further, please contact us at (202) 289-6700.
Sincerely,
Matt Muma
Senior Counsel, Health Policy
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2344-1581
3 Energy Industry Groups Oppose Moving to 24/7 Trading and Perpetual Contracts Referencing Physical Energy Commodities
Carter Struck
WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
August 26, 2026
VIA REGULATIONS.GOV
Mr. Christopher J. Kirkpatrick
Secretary of the Commission
U.S. Commodity Futures Trading Commission
Three Lafayette Centre
1155 21st Street NW
Washington, DC 20581
Re: RIN 3038-AF75 - "Request for Comment on the Extension of Standard Futures Contracts to 24/7 Trading and on Perpetual Contracts Referencing Physically Delivered or Storable Energy Commodities"
Dear Mr. Kirkpatrick:
NACS, ... Show Full Article WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 26, 2026 VIA REGULATIONS.GOV Mr. Christopher J. Kirkpatrick Secretary of the Commission U.S. Commodity Futures Trading Commission Three Lafayette Centre 1155 21st Street NW Washington, DC 20581 Re: RIN 3038-AF75 - "Request for Comment on the Extension of Standard Futures Contracts to 24/7 Trading and on Perpetual Contracts Referencing Physically Delivered or Storable Energy Commodities" Dear Mr. Kirkpatrick: NACS,NATSO, and SIGMA (the Associations) appreciate the opportunity to submit these comments to the Commodity Futures Trading Commission (the Commission) in response to its above-referenced request for comment on two related matters: the extension of standard futures contracts to 24/7 trading, and perpetual contracts referencing physically delivered or storable energy commodities (the Request). In its Request and supplemental notice, the Commission raises several fundamental market-integrity questions that implicate price reliability, manipulation risk, speculative position limits, operational readiness, clearing and settlement, customer protection, and the effects of these products on the physical markets and commercial participants who rely on them. These are questions of significant interest to our members and the markets they serve.
The Associations represent convenience retailers, travel centers, truck stops, fuel wholesalers, distributors, terminal operators, and other businesses that help move transportation energy through the downstream fuel supply chain to end-users. Collectively, these industries account for more than 90% of the motor fuels sold in the United States. As such, our members are not primarily financial-market participants. They are commercial users of energy markets who rely, directly or indirectly, on liquid and reliable futures markets to manage the price risk associated with buying, storing, transporting, and selling gasoline, diesel fuel, and other transportation fuels. Our members hedge that exposure through New York Mercantile Exchange (NYMEX) standard futures contracts with fixed monthly expirations and physical settlement-principally the West Texas Intermediate (WTI) crude oil futures, Reformulated Blendstock for Oxygenate Blending (RBOB) gasoline futures, and New York Harbor Ultra-Low Sulfur Diesel (ULSD) futures-and through the options, swaps, and physical supply arrangements priced against those benchmarks.
Informed by that perspective, we urge the Commission not to permit either of the products contemplated by the Request at this time, as neither currently satisfies the conditions on which the commercial usefulness of energy futures depends: reliable price formation, effective surveillance, and workable clearing and settlement. Standard energy futures should not trade continuously through weekends and holidays, and we support the Commission's July 9, 2026 stay of NYMEX's self-certified 10-barrel WTI crude oil futures contract (the NYMEX Oil 24/7 Contract). Likewise, perpetual contracts-instruments for which our members have identified no commercial hedging need-should not reference physically delivered or storable energy commodities, and in no event should such a contract reach the market through ordinary self-certification. But if the Commission does ultimately conclude that either product may proceed in some form, it should do so only on the conditions described below, which would help preserve the reliability of the benchmarks, settlement conventions, and hedging tools that the physical fuel markets-and, by extension, the American motoring public-depend upon.
I. Energy Futures Serve a Critical Commercial Function That Should Guide the Commission's Review
Energy futures markets exist, in large part, to help commercial participants manage real commodity-price risk. Oil futures, for example, serve that function for our members and others with physical exposure to oil and refined products because they are directly involved in the production, consumption, or trade of those commodities. Non-commercial participants can provide important liquidity by taking the other side of commercial transactions, but in some circumstances they can also trade in volumes large enough to move prices away from market fundamentals. The Commission's evaluation of both proposals should turn on that distinction: whether each product would serve commercial risk management or would primarily invite speculative trading. We recognize that continuous trading has some theoretical appeal when significant events occur outside traditional trading hours: a hedger facing a weekend natural disaster or an overnight geopolitical shock might value the ability to adjust positions immediately rather than waiting for markets to reopen. But that need already has outlets. Market participants seeking off-hours risk transfer have long had over-the-counter (OTC) alternatives like bilateral swaps and options that are not confined to exchange trading hours.
The question for the Commission, then, is whether either new product would serve an unmet commercial need while preserving the usefulness of energy futures for the hedgers and the physical markets that depend on them. From our members' perspective, that case has not yet been made. Weekend and holiday trading sessions are likely to be thin, less commercially representative, and more susceptible to market disruption, while a perpetual contract would discard the expiration and delivery mechanics that tie futures prices to physical value. Meanwhile, most fuel retailers, marketers, and distributors do not have access to fully staffed trading, treasury, credit, legal, and risk-management functions around the clock. This is the commercial reality for the businesses that buy and sell the overwhelming majority of the nation's transportation fuel, and it should carry significant weight in the Commission's review.
II. Current Market Conditions Do Not Support Approval of 24/7 Trading of Standard Energy Futures Contracts
While the Associations do not oppose market innovation, the continuous trading of physical energy commodities should not be approved merely because technology permits it. The relevant inquiry is whether additional trading days and hours would improve the quality and usefulness of price discovery for commercial hedgers-or would instead fragment liquidity, create new opportunities for manipulation, increase operational burdens, and introduce prices into contracts and benchmarks that were never designed to absorb them. Today it is the latter, as the recently stayed NYMEX Oil 24/7 Contract illustrates.
A. More Trading Days and Hours Do Not Mean Better Price Discovery
The Commission asks whether extending standard futures contracts to 24/7 trading would materially change the reliability of prices formed during overnight, weekend, and holiday periods. The answer is yes: the prices formed during these periods would, in today's market, be materially less reliable than prices formed during core trading hours.
Liquidity cannot be assumed simply because a market is open; a market can be open and still be too thin to produce prices that commercial users should be expected to rely on. If off-hours trading periods are dominated by a narrower group of participants, with lower volume, wider bid-ask spreads, or less two-sided commercial flow, price formation becomes less reliable, not more. That concern is particularly acute here because the cash markets against which our members buy and sell physical product-spot assessments and rack postings for gasoline and diesel-operate on defined weekday schedules, with price-reporting assessments conducted in set windows. A futures price printed at 3:00 a.m. on a Saturday, when no contemporaneous physical trading occurs and no assessment is being conducted, cannot fully or accurately represent dynamics in the physical underlying. It creates basis risk for hedgers who use futures to lock in physical supply costs and it degrades, rather than improves, the hedging function these contracts exist to serve.
B. Thin Off-Hours Sessions Would Invite Manipulation of Benchmark Prices
Periods of limited liquidity naturally invite abusive trading. In a thin night, weekend, or holiday session, smaller orders move prices further, one-sided flow overwhelms the order book more easily, and tactics such as spoofing, marking prices at key intervals, and engineered squeezes become cheaper to execute and harder to detect in real time.
"Spoofing" refers to bidding or offering with the intent to cancel the bid or offer before execution, creating a false appearance of supply or demand, see 7 U.S.C. Sec. 6c(a)(5)(C); "marking" refers to trading aggressively at or near a price-setting interval in order to influence the resulting settlement or reference price; and an engineered "squeeze" refers to exploiting concentrated positions or constrained deliverable supply to force counterparties to trade at distorted prices. Each tactic turns on a trader's ability to move prices relative to the capital deployed-precisely what thin one-sided sessions make easier.
Here, the Commission has identified the specific mechanism of concern to our members: a participant holding positions in a benchmark futures contract, or in related trade-at-settlement (TAS) positions, could establish a significant position before the benchmark market closes on Friday, trade a smaller 24/7 contract referencing the same underlying crude oil market over the weekend in a manner that moves prices, and thereby influence price formation when the benchmark market reopens. Because the weekend contract would trade while the benchmark contract, the listed options markets, and the physical cash market are all closed, the ordinary correcting force of two-sided commercial participation would be absent. The Commission's notice asks whether such dynamics could drive crude oil prices below zero. They could. On April 20, 2020, the expiring NYMEX WTI contract settled at negative $37.63 per barrel amid constrained storage at Cushing, Oklahoma, the contract's designated physical delivery point-and that episode unfolded during regular trading hours, in a fully surveilled market, with every ordinary safeguard operating.
If one-sided pressure can drive prices to extremes under those conditions, sessions with thinner participation, no contemporaneous cash market to anchor prices, and slower surveillance and escalation are unlikely to perform better. Our concern is not the direction of any particular price move. Distorted benchmark prices harm commercial hedgers in either direction, by impairing hedge effectiveness, triggering margin and contractual obligations, and feeding unrepresentative values into physical pricing formulas.
Oversight would also be stretched thin when it is needed most. If a contract trades 24/7, surveillance must do the same-yet night, weekend, and holiday sessions would predictably operate with leaner staffing, slower escalation paths, and less experienced personnel at exchanges, at futures commission merchants (FCMs), and at commercial firms alike. The pool of experienced physical-energy traders and surveillance professionals is finite; stretching it across every hour of every week means thinner coverage during the sessions most vulnerable to disorder.
C. Off-Hours Prices Could Increase Risks for Physical Contracts and Commercial Hedgers
Motor fuel markets are highly competitive, transparent, and operationally complex. In that environment, our members often price supply, manage inventory, and structure customer arrangements around benchmarks, averages, index references, settlement values, and other market conventions.
The physical fuel contracts to implement these arrangements were drafted against the backdrop of existing market hours and settlement conventions. If weekend or holiday prices are incorporated into official settlements, daily averages, index references, TAS mechanisms, or swap and options valuations, commercial parties could find that prices formed during periods of limited liquidity and little contemporaneous physical market activity-prices they had no practical ability to respond to when formed-influence contracts and pricing formulas throughout the supply chain, creating uncertainty about whether benchmark prices continue to reflect underlying physical market conditions. At minimum, the change could require a broad review of legacy supply, procurement, fleet, dealer, credit, and hedging arrangements.
The Commission should not assume that commercial arrangements developed around existing market conventions can seamlessly accommodate continuous price formation, particularly where benchmark prices are expected to represent periods of robust liquidity and active physical market participation. Before permitting 24/7 trading in benchmark energy contracts, the Commission should carefully evaluate how off-hours price formation would affect physical contract pricing, benchmark calculations, hedging effectiveness, and risk-management practices throughout the fuel supply chain. Changes of this nature may also create uncertainty regarding the operation of existing OTC derivatives, financing agreements, collateral arrangements, and other contracts that reference benchmark prices-including whether off-hours prices could be read to trigger valuation, collateral, or default provisions that were never drafted with such prices in mind.
D. Clearing and Payment Infrastructure Is Not a 24/7 System
The Commission also asks how margin calls and settlement obligations would work during periods when traditional payment systems-such as Fedwire and the Clearing House Interbank Payments System (CHIPS)-do not operate. For our members and other commercial users, that issue is central to whether 24/7 energy futures can operate safely at all. If key payment infrastructure is still evolving toward expanded availability, energy futures markets should not race ahead in a way that disadvantages commercial hedgers. A participant who relies on ordinary cash-management systems should not be treated worse than a participant who can move value through digital assets, tokenized collateral, or other real-time settlement arrangements.
Nor should 24/7 trading create a de facto requirement that commercial fuel businesses pre-fund larger margin buffers, hold unfamiliar payment assets, or staff treasury operations around the clock. Those costs would ultimately fall on businesses using futures markets for ordinary commercial risk management, not speculation. Pre-funded weekend buffers tie up working capital in businesses that operate on thin per-gallon margins, and any temporary liquidity facilities maintained by clearing organizations or FCMs to bridge non-banking periods would carry costs that would be passed through to commercial customers. Traditional collateral-cash, U.S. Treasury securities, and letters of credit-should remain fully eligible with low, volatility-adjusted haircuts consistent with current practice. Whatever role tokenized assets and stablecoins may ultimately play for participants that choose to use them, their use should remain a choice: commercial hedgers should not be required to post them, and the eligibility and haircut treatment of traditional collateral should not be disadvantaged in order to encourage adoption of newer alternatives.
E. The Stayed NYMEX Oil 24/7 Contract Illustrates These Concerns
These concerns were borne out on July 8, 2026, when NYMEX, a designated contract market (DCM), self-certified the NYMEX Oil 24/7 Contract-a ten-barrel contract designed to trade twenty-four hours a day, seven days a week, except for limited maintenance windows, including weekend and holiday periods during which the underlying physical crude oil market is not assessed. The Commission appropriately stayed the listing the next day under Regulation 40.2(c) to examine whether continuous trading of a standard energy future is consistent with the DCM core principles, and its extension notice now invites comment on all aspects of the contract.
The contract's very design confirms whom these products are for. A ten-barrel contract-one one-hundredth the size of the 1,000-barrel benchmark-is built for retail speculation, not commercial hedging. We are not aware of any fuel marketer that manages physical exposure ten barrels at a time. Yet because the contract references the same underlying crude oil market as the benchmark WTI contract, its weekend prices would not remain isolated from the broader market. They would shape price expectations, options values, and opening dynamics in the benchmark market that commercial hedgers actually use, and they would do so during sessions in which the benchmark market, the listed options markets, and the physical cash market cannot respond. The Commission has asked what safeguards should protect commercial users of benchmark contracts from products designed for retail traders. The most reliable safeguard is not to permit a retail-scaled satellite of a core benchmark to conduct price discovery while the benchmark market is closed.
Regulation 40.2 places the burden on the certifying exchange to demonstrate that a product complies with the Commodity Exchange Act and the Commission's regulations, including the core principles. The Commission's stay reflects that, with respect to weekend price reliability, surveillance capacity, and clearing and settlement during non-banking periods, those questions remain open. The contract should not be permitted to list unless and until the required demonstration is made on a public record.
The Commission has also asked about the timeline and sequencing for achieving operational readiness for continuous trading. The principal challenge is not whether commercial fuel businesses can adapt to 24/7 trading, but whether current market conditions can support reliable and commercially meaningful price formation during those additional trading hours. Supporting continuous trading would require around-the-clock treasury, credit, and risk-management staffing; renegotiated credit and FCM arrangements; new monitoring systems; and a review of supply and hedging contracts keyed to existing settlement conventions. These recurring costs would be incurred primarily to manage risks created by the new market structure, rather than to address a demonstrated commercial need. Before asking when industry could be ready, the Commission should first ask whether the benefits of continuous trading justify imposing those costs on commercial market participants.
F. If the Commission Nevertheless Permits 24/7 Trading, It Should First Require Strong Safeguards
Current market conditions do not support permitting standard energy futures to trade on a 24/7 basis. But, if the Commission nevertheless concludes that some form of continuous trading may proceed, it should first require, at minimum, the following safeguards.
First, the exchange seeking to list any 24/7 energy futures contract should be required to make a contract-specific showing that prices formed during each proposed trading window will be reliable and commercially useful, supported by evidence regarding expected volume, open interest, bid-ask spreads, order-book depth, trade-size distribution, participant composition, commercial versus non-commercial activity, concentration, and volatility. General statements about "access" or "innovation" should not be enough. The exchange should also be required to stress-test foreseeable weekend and holiday conditions-geopolitical events, refinery outages, pipeline or terminal disruptions, severe weather, one-sided order flow, and concentrated positions-and to make the results available to the Commission and the public.
Second, off-hours prices should not be incorporated into an exchange's official settlement prices or benchmark calculations unless the exchange demonstrates that the relevant off-hours market is sufficiently liquid, representative, and resistant to manipulation. The Commission should require clear rules and disclosures explaining whether and how off-hours prices will be used in daily and final settlement prices, TAS and related mechanisms, options valuation and exercise, swaps and other derivatives, physical supply contracts, and benchmark and index calculations, along with a transition period long enough for commercial users to review affected contracts, pricing formulas, systems, and risk-management procedures before any change becomes operative.
Third, weekend and holiday sessions should be subject to surveillance, staffing, and escalation procedures equivalent to those in place during ordinary market hours, plus strong market controls-position accountability, price limits, circuit breakers, stop-logic functionality, and trade-cancellation rules-and enhanced monitoring of activity across related contracts, including standard futures, TAS positions, options, and any linked or look-alike product trading during thinner sessions.
Fourth, before any 24/7 energy product is listed, derivatives clearing organizations (DCOs), DCMs, FCMs, and clearing members should be required to explain how margin, collateral, and forced-liquidation procedures would operate during nights, weekends, and holidays: whether margin calls will be issued during non-banking periods; what collateral will be accepted, and at what haircuts; how participants that cannot move funds until banking systems reopen will be treated; whether additional initial margin will be required before weekends or holidays; and how customer-protection rules will apply in practice. Satisfactory answers must be available before market launch, not after a stressed overnight, weekend, or holiday session exposes gaps.
III. Perpetual Contracts Should Not Reference Physically Delivered or Storable Energy Commodities
Perpetual contracts present a different and more fundamental concern. The Commission's order of May 29, 2026 permitting a DCM to list a bitcoin-linked perpetual contract was expressly limited to digital commodities with "deep, active, and continuous spot-market trading," and rested on the continuous, transaction-based observability of the bitcoin spot price. As the Request explains, the accompanying policy statement specified that perpetual contracts referencing asset classes not contemplated by that order-including energy products-"would be evaluated on their own terms." Evaluated on their own terms, physically delivered and storable energy commodities cannot today support a perpetual structure. They are tied to storage, transportation, quality, delivery locations, settlement conventions, and cash-market pricing windows. Those features make expiration, delivery, and convergence mechanisms central to the commercial utility of standard energy futures.
A. No Continuously Observable, Manipulation-Resistant Reference Price Exists for Physical Energy Commodities
Core Principle 3 permits a DCM to list only contracts that are not readily susceptible to manipulation, and the Commission's guidance in Appendix C to Part 38 provides that a cash-settled contract meets that standard only where its settlement price is reliable, publicly available, and timely, and is computed from a cash market that is sufficiently liquid and not itself readily susceptible to manipulation. A perpetual contract raises that requirement to a continuous standard: because the funding-rate mechanism operates at every funding interval rather than at a single expiration, the reference price must be reliable at every interval, around the clock, indefinitely. The contract's mark price-the value used for margining and liquidation-is derived from the same reference, so both mechanisms depend on the integrity of the reference price at each calculation interval.
No such reference exists for crude oil or refined products. There is no continuously traded, transaction-based cash market for these commodities; physical crude and products trade bilaterally and are assessed by price-reporting agencies during defined weekday windows. During nights, weekends, and holidays there is no observable cash price, and the available alternatives are insufficient. Referencing the DCM's own futures price would make the perpetual contract a derivative of a derivative and would create a direct cross-market manipulation channel, in which positions in the perpetual contract could be used to influence the referenced futures price-or vice versa-at or around each funding calculation. Referencing an assessed physical price would import a benchmark that is not published continuously and not directly surveilled by the Commission. And a composite index would inherit the weaknesses of its components. Because the threshold condition of Core Principle 3-that a contract not be readily susceptible to manipulation-cannot presently be satisfied on a continuous basis for these commodities, the inquiry should end there.
B. A Funding Rate Cannot Substitute for Expiration and Delivery in Markets with Real Carrying Costs
Standard energy futures work for commercial participants because they converge with physical value through fixed expirations and delivery. The NYMEX WTI contract is physically delivered in Cushing, Oklahoma; the RBOB gasoline and ULSD contracts that our members use to hedge motor fuels are physically delivered in New York Harbor. Each has a defined monthly expiration, and each month's price embeds the market's assessment of storage costs, transportation, seasonality, and convenience yield-the term structure, in contango or backwardation, that commercial hedgers rely on to match hedges to physical positions. Expiration and delivery are the mechanism by which futures prices remain anchored to physical fundamentals, and a perpetual contract removes that anchor by definition.
A funding rate is not a viable substitute. Funding-rate mechanisms were developed for digital assets without significant cost of carry. Nothing in a periodic funding payment naturally reflects storage economics, transportation constraints, or seasonal demand cycles, and over extended holding periods the accumulation of funding payments could interact with storage cycles and term structure to produce persistent distortions rather than convergence.
The April 2020 episode discussed above illustrates what is at stake here. That dislocation was severe, but it was contained and resolved because of the very features a perpetual contract lacks: the stress was confined to the expiring contract, later-dated months traded at positive prices the same day, and the expiration and delivery process brought the episode to a terminal close. A perpetual contract has no terminal event. A comparable dislocation would propagate through the contract's mark price, funding payments, and automatic liquidation mechanics indefinitely. Nor is it clear those mechanics would function at all under such conditions. Funding rates, margin calculations, and liquidation triggers are conventionally computed as percentages of a positive contract value; at or below zero, those calculations break down, and liquidation engines built on the assumption that prices cannot go negative would confront conditions their design never contemplated. In April 2020, established futures and options markets had to adopt emergency changes to pricing models simply to accommodate negative values-and even then they had an expiration date that ended the episode, which a perpetual contract would not have.
C. There Is No Commercial Hedging Need for an Energy Perpetual Contract
The Commission has asked whether commercial market participants such as producers, refiners, merchants, transporters, and end-users anticipate using a perpetual contract to hedge cash-market exposure. Our members have expressed no interest in doing so, and none has identified a hedging or risk-management need that existing futures, options, swaps, and OTC instruments fail to meet. The one attribute of a perpetual contract sometimes described as a benefit-eliminating the monthly roll-is a matter of convenience, not commercial necessity, and it comes at the cost of the expiration and delivery mechanics that make energy futures reliable hedging instruments in the first place.
Demand for an energy perpetual contract would therefore be, in substance, speculative demand. That matters for customer protection as well: a leveraged, no-expiration contract on a geopolitically sensitive physical commodity, offered to retail participants and subject to continuous mark-to-market, funding, and automatic liquidation mechanics, squarely presents the rapid-loss risks identified in the Commission's customer-protection questions.
D. A Perpetual Contract Cannot Be Reconciled with the Federal Position-Limits Regime
NYMEX WTI crude oil is a core referenced futures contract subject to federal speculative position limits under Part 150, with spot-month limits tied to estimated deliverable supply at Cushing. That framework presumes a contract with an expiration: the spot-month limit applies during a defined window approaching expiry and is calibrated to deliverable supply. A perpetual contract has no expiration, no spot month, and no delivery, and therefore cannot be coherently mapped into that architecture. Nor is it apparent how the bona fide hedging definition, framed around offsetting cash-market risk through positions capable of resolution in the delivery process, would apply to a position with no delivery and no terminal date.
That gap presents more than just a technical concern. Because a perpetual contract's mark and funding would reference a price that converges to physical value only through the standard contract, a large perpetual position would create an economic incentive to influence the referenced contract's price during its spot month without the perpetual contract itself ever touching delivery. That is precisely the conduct spot-month limits exist to prevent, but it would occur in an instrument to which those limits do not apply. And if a perpetual contract gained significant volume, its price signals would feed back into the standard futures contracts our members use, affecting volatility, margin requirements, and hedge reliability in the benchmark contracts themselves.
E. At Minimum, No Energy Perpetual Contract Should Be Listed Without Prior Commission Review on a Public Record
For all of these reasons, the Commission should not permit perpetual contracts to reference physically delivered or storable energy commodities. At minimum, no such product should reach the market through ordinary self-certification. The July 2026 NYMEX episode demonstrates why: a self-certified product can be listed on little more than a day's notice, before any public record exists, and the burden that Regulation 40.2 places on the certifying exchange is not tested in advance absent Commission intervention. For a product class that would need to satisfy Core Principle 3 continuously, reconcile a funding mechanism with physical carrying costs, and fit within the position-limits regime, next-day listing is not an acceptable path to market.
Any proposal to list an energy perpetual contract should instead be subject to prior Commission review on a public record. That review should require the exchange to identify a reference price that is reliable, liquid, transparent, and manipulation-resistant at every funding interval; to demonstrate that the funding mechanism is transparent, predictable, resistant to gaming, and capable of reflecting the carrying costs of the underlying commodity; to explain how the contract would be integrated into the Part 150 position-limits framework; and to address whether the contract would serve a commercial hedging need that existing instruments do not meet.
Finally, any such review should address customer protection directly, including whether access should be limited to eligible contract participants and what disclosure, suitability, and leverage safeguards would apply. Unless and until these showings are made, the answer to the Commission's line-drawing question is straightforward: crude oil and refined petroleum products are not appropriate candidates for a perpetual contract.
* * *
Energy derivatives markets are vital to the physical fuel markets. They help commercial businesses manage risk, support competitive pricing, and provide the signals that guide real-world decisions. The Commission should be open to market evolution and product innovation, as are our members. However, neither of the products addressed in the Request benefits the commercial participants these markets exist to serve. Unless and until that demonstrably changes, the Commission should decline to permit 24/7 trading of standard energy futures, should keep the stay of the NYMEX Oil 24/7 Contract in place, and should not permit perpetual contracts to reference physically delivered or storable energy commodities.
We appreciate the Commission's attention to these issues, and we would welcome the opportunity to provide additional information as its review moves forward.
Respectfully submitted,
The National Association of Convenience Stores (NACS)
NATSO, Representing America's Travel Centers and Truck Stops
SIGMA: America's Leading Fuel Marketers
Nor should these products reach U.S. customers through offshore platforms operating outside the Commission's oversight. The Commission should make clear how its existing authorities apply to such platforms and should coordinate with foreign regulators to close that channel. See 7 U.S.C. Sec. 6(a) (off-exchange futures); id. at Sec. 2(c)(2)(D) (retail commodity transactions); 17 C.F.R. pt. 48 (foreign boards of trade).
*
Original text of letter here: https://www.regulations.gov/comment/CFTC-2026-1388-0135
August 26, 2026
VIA REGULATIONS.GOV
Mr. Christopher J. Kirkpatrick
Secretary of the Commission
U.S. Commodity Futures Trading Commission
Three Lafayette Centre
1155 21st Street NW
Washington, DC 20581
Re: RIN 3038-AF75 - "Request for Comment on the Extension of Standard Futures Contracts to 24/7 Trading and on Perpetual Contracts Referencing Physically Delivered or Storable Energy Commodities"
Dear Mr. Kirkpatrick:
NACS, ... Show Full Article WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 26, 2026 VIA REGULATIONS.GOV Mr. Christopher J. Kirkpatrick Secretary of the Commission U.S. Commodity Futures Trading Commission Three Lafayette Centre 1155 21st Street NW Washington, DC 20581 Re: RIN 3038-AF75 - "Request for Comment on the Extension of Standard Futures Contracts to 24/7 Trading and on Perpetual Contracts Referencing Physically Delivered or Storable Energy Commodities" Dear Mr. Kirkpatrick: NACS,NATSO, and SIGMA (the Associations) appreciate the opportunity to submit these comments to the Commodity Futures Trading Commission (the Commission) in response to its above-referenced request for comment on two related matters: the extension of standard futures contracts to 24/7 trading, and perpetual contracts referencing physically delivered or storable energy commodities (the Request). In its Request and supplemental notice, the Commission raises several fundamental market-integrity questions that implicate price reliability, manipulation risk, speculative position limits, operational readiness, clearing and settlement, customer protection, and the effects of these products on the physical markets and commercial participants who rely on them. These are questions of significant interest to our members and the markets they serve.
The Associations represent convenience retailers, travel centers, truck stops, fuel wholesalers, distributors, terminal operators, and other businesses that help move transportation energy through the downstream fuel supply chain to end-users. Collectively, these industries account for more than 90% of the motor fuels sold in the United States. As such, our members are not primarily financial-market participants. They are commercial users of energy markets who rely, directly or indirectly, on liquid and reliable futures markets to manage the price risk associated with buying, storing, transporting, and selling gasoline, diesel fuel, and other transportation fuels. Our members hedge that exposure through New York Mercantile Exchange (NYMEX) standard futures contracts with fixed monthly expirations and physical settlement-principally the West Texas Intermediate (WTI) crude oil futures, Reformulated Blendstock for Oxygenate Blending (RBOB) gasoline futures, and New York Harbor Ultra-Low Sulfur Diesel (ULSD) futures-and through the options, swaps, and physical supply arrangements priced against those benchmarks.
Informed by that perspective, we urge the Commission not to permit either of the products contemplated by the Request at this time, as neither currently satisfies the conditions on which the commercial usefulness of energy futures depends: reliable price formation, effective surveillance, and workable clearing and settlement. Standard energy futures should not trade continuously through weekends and holidays, and we support the Commission's July 9, 2026 stay of NYMEX's self-certified 10-barrel WTI crude oil futures contract (the NYMEX Oil 24/7 Contract). Likewise, perpetual contracts-instruments for which our members have identified no commercial hedging need-should not reference physically delivered or storable energy commodities, and in no event should such a contract reach the market through ordinary self-certification. But if the Commission does ultimately conclude that either product may proceed in some form, it should do so only on the conditions described below, which would help preserve the reliability of the benchmarks, settlement conventions, and hedging tools that the physical fuel markets-and, by extension, the American motoring public-depend upon.
I. Energy Futures Serve a Critical Commercial Function That Should Guide the Commission's Review
Energy futures markets exist, in large part, to help commercial participants manage real commodity-price risk. Oil futures, for example, serve that function for our members and others with physical exposure to oil and refined products because they are directly involved in the production, consumption, or trade of those commodities. Non-commercial participants can provide important liquidity by taking the other side of commercial transactions, but in some circumstances they can also trade in volumes large enough to move prices away from market fundamentals. The Commission's evaluation of both proposals should turn on that distinction: whether each product would serve commercial risk management or would primarily invite speculative trading. We recognize that continuous trading has some theoretical appeal when significant events occur outside traditional trading hours: a hedger facing a weekend natural disaster or an overnight geopolitical shock might value the ability to adjust positions immediately rather than waiting for markets to reopen. But that need already has outlets. Market participants seeking off-hours risk transfer have long had over-the-counter (OTC) alternatives like bilateral swaps and options that are not confined to exchange trading hours.
The question for the Commission, then, is whether either new product would serve an unmet commercial need while preserving the usefulness of energy futures for the hedgers and the physical markets that depend on them. From our members' perspective, that case has not yet been made. Weekend and holiday trading sessions are likely to be thin, less commercially representative, and more susceptible to market disruption, while a perpetual contract would discard the expiration and delivery mechanics that tie futures prices to physical value. Meanwhile, most fuel retailers, marketers, and distributors do not have access to fully staffed trading, treasury, credit, legal, and risk-management functions around the clock. This is the commercial reality for the businesses that buy and sell the overwhelming majority of the nation's transportation fuel, and it should carry significant weight in the Commission's review.
II. Current Market Conditions Do Not Support Approval of 24/7 Trading of Standard Energy Futures Contracts
While the Associations do not oppose market innovation, the continuous trading of physical energy commodities should not be approved merely because technology permits it. The relevant inquiry is whether additional trading days and hours would improve the quality and usefulness of price discovery for commercial hedgers-or would instead fragment liquidity, create new opportunities for manipulation, increase operational burdens, and introduce prices into contracts and benchmarks that were never designed to absorb them. Today it is the latter, as the recently stayed NYMEX Oil 24/7 Contract illustrates.
A. More Trading Days and Hours Do Not Mean Better Price Discovery
The Commission asks whether extending standard futures contracts to 24/7 trading would materially change the reliability of prices formed during overnight, weekend, and holiday periods. The answer is yes: the prices formed during these periods would, in today's market, be materially less reliable than prices formed during core trading hours.
Liquidity cannot be assumed simply because a market is open; a market can be open and still be too thin to produce prices that commercial users should be expected to rely on. If off-hours trading periods are dominated by a narrower group of participants, with lower volume, wider bid-ask spreads, or less two-sided commercial flow, price formation becomes less reliable, not more. That concern is particularly acute here because the cash markets against which our members buy and sell physical product-spot assessments and rack postings for gasoline and diesel-operate on defined weekday schedules, with price-reporting assessments conducted in set windows. A futures price printed at 3:00 a.m. on a Saturday, when no contemporaneous physical trading occurs and no assessment is being conducted, cannot fully or accurately represent dynamics in the physical underlying. It creates basis risk for hedgers who use futures to lock in physical supply costs and it degrades, rather than improves, the hedging function these contracts exist to serve.
B. Thin Off-Hours Sessions Would Invite Manipulation of Benchmark Prices
Periods of limited liquidity naturally invite abusive trading. In a thin night, weekend, or holiday session, smaller orders move prices further, one-sided flow overwhelms the order book more easily, and tactics such as spoofing, marking prices at key intervals, and engineered squeezes become cheaper to execute and harder to detect in real time.
"Spoofing" refers to bidding or offering with the intent to cancel the bid or offer before execution, creating a false appearance of supply or demand, see 7 U.S.C. Sec. 6c(a)(5)(C); "marking" refers to trading aggressively at or near a price-setting interval in order to influence the resulting settlement or reference price; and an engineered "squeeze" refers to exploiting concentrated positions or constrained deliverable supply to force counterparties to trade at distorted prices. Each tactic turns on a trader's ability to move prices relative to the capital deployed-precisely what thin one-sided sessions make easier.
Here, the Commission has identified the specific mechanism of concern to our members: a participant holding positions in a benchmark futures contract, or in related trade-at-settlement (TAS) positions, could establish a significant position before the benchmark market closes on Friday, trade a smaller 24/7 contract referencing the same underlying crude oil market over the weekend in a manner that moves prices, and thereby influence price formation when the benchmark market reopens. Because the weekend contract would trade while the benchmark contract, the listed options markets, and the physical cash market are all closed, the ordinary correcting force of two-sided commercial participation would be absent. The Commission's notice asks whether such dynamics could drive crude oil prices below zero. They could. On April 20, 2020, the expiring NYMEX WTI contract settled at negative $37.63 per barrel amid constrained storage at Cushing, Oklahoma, the contract's designated physical delivery point-and that episode unfolded during regular trading hours, in a fully surveilled market, with every ordinary safeguard operating.
If one-sided pressure can drive prices to extremes under those conditions, sessions with thinner participation, no contemporaneous cash market to anchor prices, and slower surveillance and escalation are unlikely to perform better. Our concern is not the direction of any particular price move. Distorted benchmark prices harm commercial hedgers in either direction, by impairing hedge effectiveness, triggering margin and contractual obligations, and feeding unrepresentative values into physical pricing formulas.
Oversight would also be stretched thin when it is needed most. If a contract trades 24/7, surveillance must do the same-yet night, weekend, and holiday sessions would predictably operate with leaner staffing, slower escalation paths, and less experienced personnel at exchanges, at futures commission merchants (FCMs), and at commercial firms alike. The pool of experienced physical-energy traders and surveillance professionals is finite; stretching it across every hour of every week means thinner coverage during the sessions most vulnerable to disorder.
C. Off-Hours Prices Could Increase Risks for Physical Contracts and Commercial Hedgers
Motor fuel markets are highly competitive, transparent, and operationally complex. In that environment, our members often price supply, manage inventory, and structure customer arrangements around benchmarks, averages, index references, settlement values, and other market conventions.
The physical fuel contracts to implement these arrangements were drafted against the backdrop of existing market hours and settlement conventions. If weekend or holiday prices are incorporated into official settlements, daily averages, index references, TAS mechanisms, or swap and options valuations, commercial parties could find that prices formed during periods of limited liquidity and little contemporaneous physical market activity-prices they had no practical ability to respond to when formed-influence contracts and pricing formulas throughout the supply chain, creating uncertainty about whether benchmark prices continue to reflect underlying physical market conditions. At minimum, the change could require a broad review of legacy supply, procurement, fleet, dealer, credit, and hedging arrangements.
The Commission should not assume that commercial arrangements developed around existing market conventions can seamlessly accommodate continuous price formation, particularly where benchmark prices are expected to represent periods of robust liquidity and active physical market participation. Before permitting 24/7 trading in benchmark energy contracts, the Commission should carefully evaluate how off-hours price formation would affect physical contract pricing, benchmark calculations, hedging effectiveness, and risk-management practices throughout the fuel supply chain. Changes of this nature may also create uncertainty regarding the operation of existing OTC derivatives, financing agreements, collateral arrangements, and other contracts that reference benchmark prices-including whether off-hours prices could be read to trigger valuation, collateral, or default provisions that were never drafted with such prices in mind.
D. Clearing and Payment Infrastructure Is Not a 24/7 System
The Commission also asks how margin calls and settlement obligations would work during periods when traditional payment systems-such as Fedwire and the Clearing House Interbank Payments System (CHIPS)-do not operate. For our members and other commercial users, that issue is central to whether 24/7 energy futures can operate safely at all. If key payment infrastructure is still evolving toward expanded availability, energy futures markets should not race ahead in a way that disadvantages commercial hedgers. A participant who relies on ordinary cash-management systems should not be treated worse than a participant who can move value through digital assets, tokenized collateral, or other real-time settlement arrangements.
Nor should 24/7 trading create a de facto requirement that commercial fuel businesses pre-fund larger margin buffers, hold unfamiliar payment assets, or staff treasury operations around the clock. Those costs would ultimately fall on businesses using futures markets for ordinary commercial risk management, not speculation. Pre-funded weekend buffers tie up working capital in businesses that operate on thin per-gallon margins, and any temporary liquidity facilities maintained by clearing organizations or FCMs to bridge non-banking periods would carry costs that would be passed through to commercial customers. Traditional collateral-cash, U.S. Treasury securities, and letters of credit-should remain fully eligible with low, volatility-adjusted haircuts consistent with current practice. Whatever role tokenized assets and stablecoins may ultimately play for participants that choose to use them, their use should remain a choice: commercial hedgers should not be required to post them, and the eligibility and haircut treatment of traditional collateral should not be disadvantaged in order to encourage adoption of newer alternatives.
E. The Stayed NYMEX Oil 24/7 Contract Illustrates These Concerns
These concerns were borne out on July 8, 2026, when NYMEX, a designated contract market (DCM), self-certified the NYMEX Oil 24/7 Contract-a ten-barrel contract designed to trade twenty-four hours a day, seven days a week, except for limited maintenance windows, including weekend and holiday periods during which the underlying physical crude oil market is not assessed. The Commission appropriately stayed the listing the next day under Regulation 40.2(c) to examine whether continuous trading of a standard energy future is consistent with the DCM core principles, and its extension notice now invites comment on all aspects of the contract.
The contract's very design confirms whom these products are for. A ten-barrel contract-one one-hundredth the size of the 1,000-barrel benchmark-is built for retail speculation, not commercial hedging. We are not aware of any fuel marketer that manages physical exposure ten barrels at a time. Yet because the contract references the same underlying crude oil market as the benchmark WTI contract, its weekend prices would not remain isolated from the broader market. They would shape price expectations, options values, and opening dynamics in the benchmark market that commercial hedgers actually use, and they would do so during sessions in which the benchmark market, the listed options markets, and the physical cash market cannot respond. The Commission has asked what safeguards should protect commercial users of benchmark contracts from products designed for retail traders. The most reliable safeguard is not to permit a retail-scaled satellite of a core benchmark to conduct price discovery while the benchmark market is closed.
Regulation 40.2 places the burden on the certifying exchange to demonstrate that a product complies with the Commodity Exchange Act and the Commission's regulations, including the core principles. The Commission's stay reflects that, with respect to weekend price reliability, surveillance capacity, and clearing and settlement during non-banking periods, those questions remain open. The contract should not be permitted to list unless and until the required demonstration is made on a public record.
The Commission has also asked about the timeline and sequencing for achieving operational readiness for continuous trading. The principal challenge is not whether commercial fuel businesses can adapt to 24/7 trading, but whether current market conditions can support reliable and commercially meaningful price formation during those additional trading hours. Supporting continuous trading would require around-the-clock treasury, credit, and risk-management staffing; renegotiated credit and FCM arrangements; new monitoring systems; and a review of supply and hedging contracts keyed to existing settlement conventions. These recurring costs would be incurred primarily to manage risks created by the new market structure, rather than to address a demonstrated commercial need. Before asking when industry could be ready, the Commission should first ask whether the benefits of continuous trading justify imposing those costs on commercial market participants.
F. If the Commission Nevertheless Permits 24/7 Trading, It Should First Require Strong Safeguards
Current market conditions do not support permitting standard energy futures to trade on a 24/7 basis. But, if the Commission nevertheless concludes that some form of continuous trading may proceed, it should first require, at minimum, the following safeguards.
First, the exchange seeking to list any 24/7 energy futures contract should be required to make a contract-specific showing that prices formed during each proposed trading window will be reliable and commercially useful, supported by evidence regarding expected volume, open interest, bid-ask spreads, order-book depth, trade-size distribution, participant composition, commercial versus non-commercial activity, concentration, and volatility. General statements about "access" or "innovation" should not be enough. The exchange should also be required to stress-test foreseeable weekend and holiday conditions-geopolitical events, refinery outages, pipeline or terminal disruptions, severe weather, one-sided order flow, and concentrated positions-and to make the results available to the Commission and the public.
Second, off-hours prices should not be incorporated into an exchange's official settlement prices or benchmark calculations unless the exchange demonstrates that the relevant off-hours market is sufficiently liquid, representative, and resistant to manipulation. The Commission should require clear rules and disclosures explaining whether and how off-hours prices will be used in daily and final settlement prices, TAS and related mechanisms, options valuation and exercise, swaps and other derivatives, physical supply contracts, and benchmark and index calculations, along with a transition period long enough for commercial users to review affected contracts, pricing formulas, systems, and risk-management procedures before any change becomes operative.
Third, weekend and holiday sessions should be subject to surveillance, staffing, and escalation procedures equivalent to those in place during ordinary market hours, plus strong market controls-position accountability, price limits, circuit breakers, stop-logic functionality, and trade-cancellation rules-and enhanced monitoring of activity across related contracts, including standard futures, TAS positions, options, and any linked or look-alike product trading during thinner sessions.
Fourth, before any 24/7 energy product is listed, derivatives clearing organizations (DCOs), DCMs, FCMs, and clearing members should be required to explain how margin, collateral, and forced-liquidation procedures would operate during nights, weekends, and holidays: whether margin calls will be issued during non-banking periods; what collateral will be accepted, and at what haircuts; how participants that cannot move funds until banking systems reopen will be treated; whether additional initial margin will be required before weekends or holidays; and how customer-protection rules will apply in practice. Satisfactory answers must be available before market launch, not after a stressed overnight, weekend, or holiday session exposes gaps.
III. Perpetual Contracts Should Not Reference Physically Delivered or Storable Energy Commodities
Perpetual contracts present a different and more fundamental concern. The Commission's order of May 29, 2026 permitting a DCM to list a bitcoin-linked perpetual contract was expressly limited to digital commodities with "deep, active, and continuous spot-market trading," and rested on the continuous, transaction-based observability of the bitcoin spot price. As the Request explains, the accompanying policy statement specified that perpetual contracts referencing asset classes not contemplated by that order-including energy products-"would be evaluated on their own terms." Evaluated on their own terms, physically delivered and storable energy commodities cannot today support a perpetual structure. They are tied to storage, transportation, quality, delivery locations, settlement conventions, and cash-market pricing windows. Those features make expiration, delivery, and convergence mechanisms central to the commercial utility of standard energy futures.
A. No Continuously Observable, Manipulation-Resistant Reference Price Exists for Physical Energy Commodities
Core Principle 3 permits a DCM to list only contracts that are not readily susceptible to manipulation, and the Commission's guidance in Appendix C to Part 38 provides that a cash-settled contract meets that standard only where its settlement price is reliable, publicly available, and timely, and is computed from a cash market that is sufficiently liquid and not itself readily susceptible to manipulation. A perpetual contract raises that requirement to a continuous standard: because the funding-rate mechanism operates at every funding interval rather than at a single expiration, the reference price must be reliable at every interval, around the clock, indefinitely. The contract's mark price-the value used for margining and liquidation-is derived from the same reference, so both mechanisms depend on the integrity of the reference price at each calculation interval.
No such reference exists for crude oil or refined products. There is no continuously traded, transaction-based cash market for these commodities; physical crude and products trade bilaterally and are assessed by price-reporting agencies during defined weekday windows. During nights, weekends, and holidays there is no observable cash price, and the available alternatives are insufficient. Referencing the DCM's own futures price would make the perpetual contract a derivative of a derivative and would create a direct cross-market manipulation channel, in which positions in the perpetual contract could be used to influence the referenced futures price-or vice versa-at or around each funding calculation. Referencing an assessed physical price would import a benchmark that is not published continuously and not directly surveilled by the Commission. And a composite index would inherit the weaknesses of its components. Because the threshold condition of Core Principle 3-that a contract not be readily susceptible to manipulation-cannot presently be satisfied on a continuous basis for these commodities, the inquiry should end there.
B. A Funding Rate Cannot Substitute for Expiration and Delivery in Markets with Real Carrying Costs
Standard energy futures work for commercial participants because they converge with physical value through fixed expirations and delivery. The NYMEX WTI contract is physically delivered in Cushing, Oklahoma; the RBOB gasoline and ULSD contracts that our members use to hedge motor fuels are physically delivered in New York Harbor. Each has a defined monthly expiration, and each month's price embeds the market's assessment of storage costs, transportation, seasonality, and convenience yield-the term structure, in contango or backwardation, that commercial hedgers rely on to match hedges to physical positions. Expiration and delivery are the mechanism by which futures prices remain anchored to physical fundamentals, and a perpetual contract removes that anchor by definition.
A funding rate is not a viable substitute. Funding-rate mechanisms were developed for digital assets without significant cost of carry. Nothing in a periodic funding payment naturally reflects storage economics, transportation constraints, or seasonal demand cycles, and over extended holding periods the accumulation of funding payments could interact with storage cycles and term structure to produce persistent distortions rather than convergence.
The April 2020 episode discussed above illustrates what is at stake here. That dislocation was severe, but it was contained and resolved because of the very features a perpetual contract lacks: the stress was confined to the expiring contract, later-dated months traded at positive prices the same day, and the expiration and delivery process brought the episode to a terminal close. A perpetual contract has no terminal event. A comparable dislocation would propagate through the contract's mark price, funding payments, and automatic liquidation mechanics indefinitely. Nor is it clear those mechanics would function at all under such conditions. Funding rates, margin calculations, and liquidation triggers are conventionally computed as percentages of a positive contract value; at or below zero, those calculations break down, and liquidation engines built on the assumption that prices cannot go negative would confront conditions their design never contemplated. In April 2020, established futures and options markets had to adopt emergency changes to pricing models simply to accommodate negative values-and even then they had an expiration date that ended the episode, which a perpetual contract would not have.
C. There Is No Commercial Hedging Need for an Energy Perpetual Contract
The Commission has asked whether commercial market participants such as producers, refiners, merchants, transporters, and end-users anticipate using a perpetual contract to hedge cash-market exposure. Our members have expressed no interest in doing so, and none has identified a hedging or risk-management need that existing futures, options, swaps, and OTC instruments fail to meet. The one attribute of a perpetual contract sometimes described as a benefit-eliminating the monthly roll-is a matter of convenience, not commercial necessity, and it comes at the cost of the expiration and delivery mechanics that make energy futures reliable hedging instruments in the first place.
Demand for an energy perpetual contract would therefore be, in substance, speculative demand. That matters for customer protection as well: a leveraged, no-expiration contract on a geopolitically sensitive physical commodity, offered to retail participants and subject to continuous mark-to-market, funding, and automatic liquidation mechanics, squarely presents the rapid-loss risks identified in the Commission's customer-protection questions.
D. A Perpetual Contract Cannot Be Reconciled with the Federal Position-Limits Regime
NYMEX WTI crude oil is a core referenced futures contract subject to federal speculative position limits under Part 150, with spot-month limits tied to estimated deliverable supply at Cushing. That framework presumes a contract with an expiration: the spot-month limit applies during a defined window approaching expiry and is calibrated to deliverable supply. A perpetual contract has no expiration, no spot month, and no delivery, and therefore cannot be coherently mapped into that architecture. Nor is it apparent how the bona fide hedging definition, framed around offsetting cash-market risk through positions capable of resolution in the delivery process, would apply to a position with no delivery and no terminal date.
That gap presents more than just a technical concern. Because a perpetual contract's mark and funding would reference a price that converges to physical value only through the standard contract, a large perpetual position would create an economic incentive to influence the referenced contract's price during its spot month without the perpetual contract itself ever touching delivery. That is precisely the conduct spot-month limits exist to prevent, but it would occur in an instrument to which those limits do not apply. And if a perpetual contract gained significant volume, its price signals would feed back into the standard futures contracts our members use, affecting volatility, margin requirements, and hedge reliability in the benchmark contracts themselves.
E. At Minimum, No Energy Perpetual Contract Should Be Listed Without Prior Commission Review on a Public Record
For all of these reasons, the Commission should not permit perpetual contracts to reference physically delivered or storable energy commodities. At minimum, no such product should reach the market through ordinary self-certification. The July 2026 NYMEX episode demonstrates why: a self-certified product can be listed on little more than a day's notice, before any public record exists, and the burden that Regulation 40.2 places on the certifying exchange is not tested in advance absent Commission intervention. For a product class that would need to satisfy Core Principle 3 continuously, reconcile a funding mechanism with physical carrying costs, and fit within the position-limits regime, next-day listing is not an acceptable path to market.
Any proposal to list an energy perpetual contract should instead be subject to prior Commission review on a public record. That review should require the exchange to identify a reference price that is reliable, liquid, transparent, and manipulation-resistant at every funding interval; to demonstrate that the funding mechanism is transparent, predictable, resistant to gaming, and capable of reflecting the carrying costs of the underlying commodity; to explain how the contract would be integrated into the Part 150 position-limits framework; and to address whether the contract would serve a commercial hedging need that existing instruments do not meet.
Finally, any such review should address customer protection directly, including whether access should be limited to eligible contract participants and what disclosure, suitability, and leverage safeguards would apply. Unless and until these showings are made, the answer to the Commission's line-drawing question is straightforward: crude oil and refined petroleum products are not appropriate candidates for a perpetual contract.
* * *
Energy derivatives markets are vital to the physical fuel markets. They help commercial businesses manage risk, support competitive pricing, and provide the signals that guide real-world decisions. The Commission should be open to market evolution and product innovation, as are our members. However, neither of the products addressed in the Request benefits the commercial participants these markets exist to serve. Unless and until that demonstrably changes, the Commission should decline to permit 24/7 trading of standard energy futures, should keep the stay of the NYMEX Oil 24/7 Contract in place, and should not permit perpetual contracts to reference physically delivered or storable energy commodities.
We appreciate the Commission's attention to these issues, and we would welcome the opportunity to provide additional information as its review moves forward.
Respectfully submitted,
The National Association of Convenience Stores (NACS)
NATSO, Representing America's Travel Centers and Truck Stops
SIGMA: America's Leading Fuel Marketers
Nor should these products reach U.S. customers through offshore platforms operating outside the Commission's oversight. The Commission should make clear how its existing authorities apply to such platforms and should coordinate with foreign regulators to close that channel. See 7 U.S.C. Sec. 6(a) (off-exchange futures); id. at Sec. 2(c)(2)(D) (retail commodity transactions); 17 C.F.R. pt. 48 (foreign boards of trade).
*
Original text of letter here: https://www.regulations.gov/comment/CFTC-2026-1388-0135
Airlines for America Urges FAA to Conduct Comprehensive Impact Analysis of Commercial Space Reentry Operations
Carter Struck
WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
August 28, 2026
Leslie Grey
FAA Environmental Protection Specialist
Federal Aviation Administration
To Leslie Grey:
Airlines for America (A4A), the trade association representing the leading U.S. passenger and cargo airlines, appreciates the opportunity to comment on the Draft Environmental Assessment for Reditus Space (Reditus) ENOS Capsule Reentries in the Gulf of America (Draft EA).
A4A supports the continued ... Show Full Article WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 28, 2026 Leslie Grey FAA Environmental Protection Specialist Federal Aviation Administration To Leslie Grey: Airlines for America (A4A), the trade association representing the leading U.S. passenger and cargo airlines, appreciates the opportunity to comment on the Draft Environmental Assessment for Reditus Space (Reditus) ENOS Capsule Reentries in the Gulf of America (Draft EA). A4A supports the continuedadvancement of U.S. commercial space activities and recognizes the important role that commercial launch providers play in supporting national objectives related to space exploration, scientific advancement and national security. At the same time, the Federal Aviation Administration (FAA) has a statutory obligation to ensure both safety and the efficient use of the National Airspace System (NAS). The Draft EA understates the operational, economic and environmental impacts that would result from the proposed airspace restrictions.
Commercial aviation is a critical economic engine for the United States, contributing 5% of U.S. GDP - equivalent to $1.54 trillion in 2025. U.S. airlines alone operate approximately 28,000 flights per day, transporting 2.7 million passengers to and from more than 80 countries and 61,000 tons of cargo to and from more than 220 countries. In 2025, FAA air traffic controllers handled 47,000 daily flights operated by a combination of U.S. and foreign-flag passenger and cargo airlines (67%), business and nonbusiness general aviation (28%) and military and civilian government (5%). The FAA Aerospace Forecast FY 2025-2045 projects total aircraft handled at FAA En Route Centers to grow 1.7% annually over the next 20 years.
Given these high and growing levels of aviation activity, the importance of the aviation industry to the nation and the emergence of new technologies and entrants into the airspace, investment in the NAS is more critical than ever. That is why the Modern Skies Coalition-representing more than 50 leading aviation and aerospace organizations across industry and labor-has identified modernization of our nation's air traffic system as a top national priority. We are grateful to the Administration and Congress for making a historic $12.5 billion investment to address outdated technology and deteriorating infrastructure, marking an important first step toward a more efficient NAS while maintaining the highest safety standards.
Reditus is proposing to conduct the reentry, splashdown and recovery (RSR) operations of its ENOS-Mk1 (ENOS) capsule in the Gulf of America. To do so, Reditus must obtain a license from the FAA, Office of Commercial Space Transportation (AST), and the FAA confirms that issuing a license is considered a major federal action under the National Environmental Policy Act (NEPA). Accordingly, FAA has prepared its Draft EA to evaluate the potential environmental impacts associated with the proposed action. The ENOS spacecraft would be launched as a payload on a Space Exploration Technologies Corporation (SpaceX) Falcon 9 from the Vandenberg Space Force Base (VSFB), California, and the associated environmental impacts for the launch were most recently analyzed by the Department of the Air Force (DAF) and FAA issued a Record of Decision. Therefore, the scope of operations analyzed in this EA is limited to the proposed RSR operations in the Gulf of America.
The FAA manages commercial space operations with the designation of Aviation Hazard Areas (AHA) and other safety measures intended to protect the public and ensure the safe integration of commercial space activities into the NAS. To manage traffic flow around temporary airspace restrictions associated with commercial space operations, the FAA may employ a variety of Traffic Management Initiatives (TMIs) including Miles-in-Trail restrictions, Minutes-in-Trail restrictions, Required Reroutes, Ground Delay Programs, Ground Stops and Airspace Flow Programs.
Under the Proposed Action, Reditus would conduct up to 12 daytime reentries annually within an AHA extending approximately 250 nautical miles north-to-south and between 8 and 22 nautical miles in width in the northeastern Gulf of America. The Draft EA acknowledges that the notional AHA could affect as few as two commercial aircraft per hour during low traffic periods and as many as 104 commercial aircraft per hour during peak daily travel periods. Although the FAA concludes that significant NAS impacts are not anticipated and that strategic flow management measures may not be required, aircraft operating through this region would nonetheless be subject to tactical reroutes and other operational adjustments while the AHA is active.
A4A is not only concerned about delay impacts associated with these operations, but also the resulting effects on airline operating costs, fuel consumption, greenhouse gas emissions, schedule reliability and passenger connectivity. The Draft EA acknowledges that some aircraft may be rerouted around the AHA and therefore expend additional fuel, yet it does not quantify reroute mileage, delay minutes, fuel burn, emissions consequences, passenger impacts or broader network effects. Without such analysis, it is difficult to evaluate the basis for the FAA's conclusion that the operational impacts of the Proposed Action would be negligible.
Given the concentration of traffic in Florida airspace and the importance of Gulf routing structures for both domestic and international operations, A4A strongly encourages the FAA and Reditus to schedule reentries during periods of lower commercial traffic whenever feasible. In addition, advance coordination to facilitate access to adjacent offshore Warning Areas could help mitigate impacts by providing more direct rerouting options and reducing the need to shift traffic toward already congested mainland Florida airspace.
The FAA's analysis also appears to focus largely on the approximately 15-minute period between atmospheric entry and splashdown. However, the operational effects experienced by airlines often extend beyond the period during which the AHA is active. Strategic traffic management actions may need to be implemented before the closure becomes effective, and recovery of normal traffic flows requires additional time after the operation is complete. Consequently, the operational consequences for aircraft operators may be materially greater than the duration of the closure alone would suggest.
The Draft EA likewise does not adequately evaluate the operational safety implications associated with recurring airspace restrictions and the TMIs that may be required to support either nominal or contingency operations. Reroutes, Miles-in-Trail restrictions and other flow management measures can concentrate traffic into constrained corridors, increase controller workload, reduce flexibility to avoid convective weather and other hazards and create additional complexity across multiple facilities and sectors. These challenges may be compounded when reentry activities coincide with thunderstorms, tropical weather, turbulence advisories, military airspace usage or other operational constraints that already limit available routing options. The FAA should evaluate these combined operational conditions to better understand their implications for NAS safety, efficiency and resilience.
Similarly, the Draft EA does not sufficiently assess the operational consequences of contingency events requiring activation of AHAs or Debris Response Areas (DRAs). Although the probability of such events may be low, unexpected vehicle anomalies can require the rapid implementation of airspace restrictions and corresponding traffic management actions. The resulting effects can extend flight and duty periods, create crew scheduling challenges, disrupt passenger itineraries and generate network impacts that persist well beyond the duration of the closure itself. The Final EA should therefore evaluate contingency operations not solely as temporary airspace closures, but as events with broader operational, safety, efficiency and recovery implications across the NAS.
The Final EA should not assume that recurring reentry operations can be absorbed by the NAS without meaningful operational effects. Airspace capacity and traffic management resources are already constrained by facility staffing limitations, periods of high demand, convective weather, military airspace activity and other concurrent restrictions that can sharply reduce routing flexibility. In that environment, even a short-duration AHA can require complex traffic management decisions before, during and after the closure, particularly if a planned operation or contingency event occurs during an already degraded operating period. FAA should therefore assess these operations in the context in which they will actually occur-not as isolated events, but as additional constraints on a dynamic and heavily utilized system. Such an analysis is necessary to determine whether recurring reentries could increase safety risk, reduce NAS resilience, or magnify delay, fuel burn, emissions and recovery impacts beyond those identified in the Draft EA.
Accordingly, A4A respectfully urges the FAA to supplement the Final EA with a more comprehensive analysis of the operational, economic, environmental and NAS recovery impacts associated with the proposed reentry operations. At a minimum, the FAA should assess potential reroute mileage, delay minutes, fuel burn, emissions impacts, controller workload, schedule reliability effects, passenger disruptions and cumulative operational impacts associated with recurring reentry activities and contingency events. Such information would provide stakeholders and decision makers with a more complete understanding of the consequences of the Proposed Action and better support the FAA's conclusions under NEPA.
Sincerely,
Kevin Welsh Vice President, Environmental Affairs and Chief Sustainability Officer
*
Original text of letter here: https://www.regulations.gov/comment/FAA-2013-0259-5387
August 28, 2026
Leslie Grey
FAA Environmental Protection Specialist
Federal Aviation Administration
To Leslie Grey:
Airlines for America (A4A), the trade association representing the leading U.S. passenger and cargo airlines, appreciates the opportunity to comment on the Draft Environmental Assessment for Reditus Space (Reditus) ENOS Capsule Reentries in the Gulf of America (Draft EA).
A4A supports the continued ... Show Full Article WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 28, 2026 Leslie Grey FAA Environmental Protection Specialist Federal Aviation Administration To Leslie Grey: Airlines for America (A4A), the trade association representing the leading U.S. passenger and cargo airlines, appreciates the opportunity to comment on the Draft Environmental Assessment for Reditus Space (Reditus) ENOS Capsule Reentries in the Gulf of America (Draft EA). A4A supports the continuedadvancement of U.S. commercial space activities and recognizes the important role that commercial launch providers play in supporting national objectives related to space exploration, scientific advancement and national security. At the same time, the Federal Aviation Administration (FAA) has a statutory obligation to ensure both safety and the efficient use of the National Airspace System (NAS). The Draft EA understates the operational, economic and environmental impacts that would result from the proposed airspace restrictions.
Commercial aviation is a critical economic engine for the United States, contributing 5% of U.S. GDP - equivalent to $1.54 trillion in 2025. U.S. airlines alone operate approximately 28,000 flights per day, transporting 2.7 million passengers to and from more than 80 countries and 61,000 tons of cargo to and from more than 220 countries. In 2025, FAA air traffic controllers handled 47,000 daily flights operated by a combination of U.S. and foreign-flag passenger and cargo airlines (67%), business and nonbusiness general aviation (28%) and military and civilian government (5%). The FAA Aerospace Forecast FY 2025-2045 projects total aircraft handled at FAA En Route Centers to grow 1.7% annually over the next 20 years.
Given these high and growing levels of aviation activity, the importance of the aviation industry to the nation and the emergence of new technologies and entrants into the airspace, investment in the NAS is more critical than ever. That is why the Modern Skies Coalition-representing more than 50 leading aviation and aerospace organizations across industry and labor-has identified modernization of our nation's air traffic system as a top national priority. We are grateful to the Administration and Congress for making a historic $12.5 billion investment to address outdated technology and deteriorating infrastructure, marking an important first step toward a more efficient NAS while maintaining the highest safety standards.
Reditus is proposing to conduct the reentry, splashdown and recovery (RSR) operations of its ENOS-Mk1 (ENOS) capsule in the Gulf of America. To do so, Reditus must obtain a license from the FAA, Office of Commercial Space Transportation (AST), and the FAA confirms that issuing a license is considered a major federal action under the National Environmental Policy Act (NEPA). Accordingly, FAA has prepared its Draft EA to evaluate the potential environmental impacts associated with the proposed action. The ENOS spacecraft would be launched as a payload on a Space Exploration Technologies Corporation (SpaceX) Falcon 9 from the Vandenberg Space Force Base (VSFB), California, and the associated environmental impacts for the launch were most recently analyzed by the Department of the Air Force (DAF) and FAA issued a Record of Decision. Therefore, the scope of operations analyzed in this EA is limited to the proposed RSR operations in the Gulf of America.
The FAA manages commercial space operations with the designation of Aviation Hazard Areas (AHA) and other safety measures intended to protect the public and ensure the safe integration of commercial space activities into the NAS. To manage traffic flow around temporary airspace restrictions associated with commercial space operations, the FAA may employ a variety of Traffic Management Initiatives (TMIs) including Miles-in-Trail restrictions, Minutes-in-Trail restrictions, Required Reroutes, Ground Delay Programs, Ground Stops and Airspace Flow Programs.
Under the Proposed Action, Reditus would conduct up to 12 daytime reentries annually within an AHA extending approximately 250 nautical miles north-to-south and between 8 and 22 nautical miles in width in the northeastern Gulf of America. The Draft EA acknowledges that the notional AHA could affect as few as two commercial aircraft per hour during low traffic periods and as many as 104 commercial aircraft per hour during peak daily travel periods. Although the FAA concludes that significant NAS impacts are not anticipated and that strategic flow management measures may not be required, aircraft operating through this region would nonetheless be subject to tactical reroutes and other operational adjustments while the AHA is active.
A4A is not only concerned about delay impacts associated with these operations, but also the resulting effects on airline operating costs, fuel consumption, greenhouse gas emissions, schedule reliability and passenger connectivity. The Draft EA acknowledges that some aircraft may be rerouted around the AHA and therefore expend additional fuel, yet it does not quantify reroute mileage, delay minutes, fuel burn, emissions consequences, passenger impacts or broader network effects. Without such analysis, it is difficult to evaluate the basis for the FAA's conclusion that the operational impacts of the Proposed Action would be negligible.
Given the concentration of traffic in Florida airspace and the importance of Gulf routing structures for both domestic and international operations, A4A strongly encourages the FAA and Reditus to schedule reentries during periods of lower commercial traffic whenever feasible. In addition, advance coordination to facilitate access to adjacent offshore Warning Areas could help mitigate impacts by providing more direct rerouting options and reducing the need to shift traffic toward already congested mainland Florida airspace.
The FAA's analysis also appears to focus largely on the approximately 15-minute period between atmospheric entry and splashdown. However, the operational effects experienced by airlines often extend beyond the period during which the AHA is active. Strategic traffic management actions may need to be implemented before the closure becomes effective, and recovery of normal traffic flows requires additional time after the operation is complete. Consequently, the operational consequences for aircraft operators may be materially greater than the duration of the closure alone would suggest.
The Draft EA likewise does not adequately evaluate the operational safety implications associated with recurring airspace restrictions and the TMIs that may be required to support either nominal or contingency operations. Reroutes, Miles-in-Trail restrictions and other flow management measures can concentrate traffic into constrained corridors, increase controller workload, reduce flexibility to avoid convective weather and other hazards and create additional complexity across multiple facilities and sectors. These challenges may be compounded when reentry activities coincide with thunderstorms, tropical weather, turbulence advisories, military airspace usage or other operational constraints that already limit available routing options. The FAA should evaluate these combined operational conditions to better understand their implications for NAS safety, efficiency and resilience.
Similarly, the Draft EA does not sufficiently assess the operational consequences of contingency events requiring activation of AHAs or Debris Response Areas (DRAs). Although the probability of such events may be low, unexpected vehicle anomalies can require the rapid implementation of airspace restrictions and corresponding traffic management actions. The resulting effects can extend flight and duty periods, create crew scheduling challenges, disrupt passenger itineraries and generate network impacts that persist well beyond the duration of the closure itself. The Final EA should therefore evaluate contingency operations not solely as temporary airspace closures, but as events with broader operational, safety, efficiency and recovery implications across the NAS.
The Final EA should not assume that recurring reentry operations can be absorbed by the NAS without meaningful operational effects. Airspace capacity and traffic management resources are already constrained by facility staffing limitations, periods of high demand, convective weather, military airspace activity and other concurrent restrictions that can sharply reduce routing flexibility. In that environment, even a short-duration AHA can require complex traffic management decisions before, during and after the closure, particularly if a planned operation or contingency event occurs during an already degraded operating period. FAA should therefore assess these operations in the context in which they will actually occur-not as isolated events, but as additional constraints on a dynamic and heavily utilized system. Such an analysis is necessary to determine whether recurring reentries could increase safety risk, reduce NAS resilience, or magnify delay, fuel burn, emissions and recovery impacts beyond those identified in the Draft EA.
Accordingly, A4A respectfully urges the FAA to supplement the Final EA with a more comprehensive analysis of the operational, economic, environmental and NAS recovery impacts associated with the proposed reentry operations. At a minimum, the FAA should assess potential reroute mileage, delay minutes, fuel burn, emissions impacts, controller workload, schedule reliability effects, passenger disruptions and cumulative operational impacts associated with recurring reentry activities and contingency events. Such information would provide stakeholders and decision makers with a more complete understanding of the consequences of the Proposed Action and better support the FAA's conclusions under NEPA.
Sincerely,
Kevin Welsh Vice President, Environmental Affairs and Chief Sustainability Officer
*
Original text of letter here: https://www.regulations.gov/comment/FAA-2013-0259-5387
AAPM&R Urges CMS to Reconsider Expanding Prior Authorization for Botulinum Toxin Injections to Avoid Treatment Delays
Carter Struck
WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
August 31, 2026
The Honorable Mehmet Oz, MD, MBA
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attn: CMS-1850-P
7500 Security Boulevard
Baltimore, MD 21244
RE: Medicare Program: Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems; and Quality Reporting
Programs; Including the Hospital Outpatient Quality Reporting Program ... Show Full Article WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 31, 2026 The Honorable Mehmet Oz, MD, MBA Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attn: CMS-1850-P 7500 Security Boulevard Baltimore, MD 21244 RE: Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Programand
Ambulatory Surgical Center Quality Program [CMS-1850-P]
Dear Administrator Oz:
On behalf of the more than 9,000 physiatrists of the American Academy of
Physical Medicine and Rehabilitation (AAPM&R), we appreciate the
opportunity to submit comments to the Centers for Medicare & Medicaid
Services (CMS) in response to the Calendar Year (CY) 2026 Medicare
Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical
Center (ASC) Payment System proposed rule referenced above. AAPM&R is the
national medical specialty organization representing physicians who are
specialists in physical medicine and rehabilitation (PM&R). PM&R physicians,
also known as physiatrists, treat a wide variety of medical conditions affecting
the brain, spinal cord, nerves, bones, joints, ligaments, muscles, and tendons.
PM&R physicians evaluate and treat injuries, illnesses, and disability and are
experts in designing comprehensive, patient-centered treatment plans.
Physiatrists utilize cutting-edge as well as time-tested treatments to maximize
function and quality of life.
Expansion of Botulinum Toxin Injection Codes for Hospital
Outpatient Department (OPD) Prior Authorization Processes
CMS proposes to expand prior authorization requirements under the Hospital
Outpatient Department (OPD) prior authorization process to include eight
additional botulinum toxin injection codes, effective for services provided on
or after July 1, 2027.
AAPM&R has significant concerns with this proposal
and urges CMS not to finalize the addition of the new botulinum toxin
codes.
We commend CMS for its efforts to identify fraud and abuse and preserve the
integrity and sustainability of the Medicare program. At the same time,
program-integrity measures should be carefully targeted to areas in which
evidence demonstrates a meaningful risk of improper utilization, so that
efforts to prevent fraud do not inadvertently create barriers to timely, medically
necessary care.
Although isolated cases of fraud involving botulinum toxin have been reported,
we are unaware of evidence demonstrating meaningful fraud or abuse of
botulinum toxin procedure billing among PM&R physicians. Imposing prior
authorization broadly on these services would place substantial administrative
burden on the specialty that provides much of the nation's spasticity care
while risking treatment delays for particularly vulnerable patients with stroke,
traumatic brain injury, spinal cord injury, multiple sclerosis, cerebral palsy,
ALS, and other neurologic disabilities. Delays in the treatment of abnormal
muscle tone can result in pain, impaired function, and increased caregiver
burden, as well as potentially preventable complications such as joint
contractures and wounds; conditions that are far easier and less costly to
prevent than to treat once they occur.
CMS points to significant increases in utilization of botulinum toxin codes from
2017 through 2024 as a major justification for including these services under
the OPD prior authorization process.
We disagree that increased utilization
alone provides sufficient rationale to support this proposal.
To begin, as
CMS identifies, one factor contributing to this increased utilization is the
expansion of FDA-approved indications for the use of botulinum toxin products
that occurred over this period, which we do not believe should be discounted.
Importantly, we also note that a major contributor to increased botulinum toxin
utilization is a concerted effort in recent years across the rehabilitation
community to increase awareness of and treatment for spasticity, which is
effectively treated with botulinum toxin interventions. This effort is in response
to well-documented evidence of undertreatment for the condition
1,2
and the
associated patient burden.
3
Rather than reflecting fraud or abuse, we believe
1
Patel A, Gellhorn A, Neerukonda K, Kwasnica C. Multidisciplinary collaborative
consensus statement on the barriers and solutions to care access, patient and
caregiver support, and clinical capacity and capability for patients with spasticity. PM
R. 2
024 Mar;16(3):278-286
https://doi.org/10.1002/pmrj.13106
2
Baricich A, Wein T, Cinone N, Bertoni M, Picelli A, Chisari C, Molteni F, Santamato A.
BoNT-A for Post-Stroke Spasticity: Guidance on Unmet Clinical Needs from a Delphi
Panel Approach.
Toxins. 2021; 13(4):236.
https://doi.org/10.3390/toxins13040236
3
Patel A, Wein T, Bahroo L, et al. Burden of spasticity among patients and caregivers:
Results of a multinational survey. Neurology. 2019 Apr; 92(15 supplement) P5.6-019.
https://doi.org/10.1212/WNL.92.15_supplement.P5.6-019
that growth in utilization reflects the fact that more patients have been seeking
- and more physicians have been delivering - appropriate treatment for
spasticity over this time period. This is especially true for post-stroke patients,
for whom spasticity management has been prioritized given the incidence and
impact of spasticity in the population.
It is difficult to determine whether the prevalence of spasticity has increased
and may therefore be contributing to greater utilization of CPT codes 64642
and 64644. This uncertainty is compounded by the absence of a dedicated
ICD-10-CM code for spasticity, which limits our ability to reliably track its
prevalence and utilization of associated treatments. Recognizing this gap,
AAPM&R has proposed creation of a dedicated ICD-10-CM code for spasticity
and will present this proposal to the CDC's ICD-10-CM Coordination and
Maintenance Committee in September. We anticipate a new ICD-10-CM code
for spasticity could better document the medically appropriate nature of
botulinum toxin services.
Nevertheless, there are compelling reasons to expect that the number of
patients requiring treatment for spasticity has increased. Post-stroke spasticity
is a leading indication for botulinum toxin injections, and the population of
Americans living with the consequences of stroke has grown and is projected
to continue increasing, driven in part by an aging population, prevalence of risk
factors, and improved stroke survival
4
. Increased utilization of these services
should therefore not, in itself, be interpreted as evidence of inappropriate
utilization.
AAPM&R members have long expressed deep concerns with the outsized and
unnecessary administrative burden placed on physicians across the spectrum
of care, a burden that has only continued to grow in recent years with the
expansion of overly onerous prior authorization and utilization management
requirements. Far too much of a PM&R physician's time is currently spent
documenting medical necessity and meeting arbitrary timelines that often
bear little clinical relevance to quality medical treatment or outcomes for
patients. Data related to physician burnout clearly demonstrates the toll that
overly burdensome compliance requirements and other administrative
burdens place on physiatrists.
4
Park JH, Chang Y, Park S, Song TJ. Burden of stroke in the United States of America,
1990-2021: a systematic analysis for the US burden of disease study 2021. Front
Neurol. 2025;16:1609508. Published 2025 Aug 14. doi:10.3389/fneur.2025.1609508
(
Frontiers | Burden of stroke in the United States of America, 1990-2021: a systematic
analysis for the US burden of disease study 2021
)
The Regulatory Relief Coalition, a group of national physician specialty
organizations advocating for regulatory burden
reduction in Medicare so that
physicians can spend more time treating patients, conducted a survey
5
of
physicians on the impact that prior authorization has on their practices. The
survey found, among other things, that:
Eighty-two percent of respondents state that prior authorization
always (37%) or often (45%) delays access to necessary care;
Wait times can be lengthy:
For most physicians (74%), it takes
between 2 to 14 days to obtain prior authorization, and for 15%, this
process can take 15 to more than 31 days;
Thirty-two percent (32%) of respondents report that patients often
abandon treatment, and 50% report that patients sometimes
abandon treatment;
Overwhelmingly (87%), physicians report that prior authorization has
a significant (40%) or somewhat (47%) negative impact on patient
clinical outcomes; and
Ultimately, most services are approved, with one-third of physicians
getting approved 90% of the time or more.
To the extent that CMS is concerned about inappropriate utilization,
including potential fraud or abuse, AAPM&R recommends that CMS utilize
less burdensome tools to address potential overutilization rather than new
across-the-board prior authorization requirements as proposed.
This could
include expanded outreach and education, as well as use of targeted post-
claim review procedures for high-risk providers, including comparative billing
reports, Targeted Probe and Educate (TPE) reviews, and reviews by CMS
program integrity contractors. Such an approach would limit burden for
compliant providers and support appropriate access to medically necessary
care for the management of spasticity.
Given the excessive burdens that physicians are already facing from
unnecessary prior authorization practices,
AAPM&R does not believe that it
would be beneficial to patients or providers for CMS to expand prior
authorization requirements for OPD services to include additional
botulinum toxin injections.
5
RRC Prior Authorization Survey,
https://www.regrelief.org/wp-
content/uploads/2019/12/RRC-Prior-Authorization-Survey-Results-FINAL-7-26.pdf
OPPS Payments for Software as a Medical Services (SaMS)
Diagnostic Services
CMS discusses the increasing role of software-based technologies - including
artificial intelligence (AI) - to support clinical decision-making in the outpatient
and physician office settings and considers how to accommodate such
technologies in the Medicare program. As part of this effort, CMS proposes to
change the terminology it has been using from "Software as a Service" (SaaS)
to "Software as a Medical Service" (SaMS) in order to dispel ambiguity and
clarify the distinction between cloud-based computing service models that the
term SaaS often connotes and the software-based technologies that support
clinical decision making through algorithmic analysis that CMS is
contemplating. CMS also proposes to establish a dedicated but interim billing
pathway for algorithm-driven clinical software (e.g., AI and diagnostic tools)
that aid physician work, including assigning a new status indicator, O1, to
ensure separate, distinct APC payments.
AAPM&R supports the proposed
change in terminology and appreciates that CMS is pursuing efforts to
identify appropriate avenues for coverage and payment of SaMS furnished
in outpatient hospital and physician office settings.
We note that cost or affordability continues to be a significant barrier to
implementation of AI and other SaMS, including for physician practices and
hospital outpatient departments. These technologies require significant
investment of both time and financial resources without a guaranteed return
on investment. AAPM&R therefore appreciates thoughtful exploration of
Medicare reimbursement policy with respect to the range of SaMS
technologies, including AI.
As CMS contemplates how best to incorporate SaMS into Medicare payment
policy, we highlight that current reimbursement is limited for AI tools due to a
lack of a straightforward connection between AI and the current fee-for-service
payment structure. We recognize that the American Medical Association's
(AMA's) Current Procedural Terminology (CPT) Editorial Panel is working to
modernize the CPT code set to accommodate the range of rapidly emerging
technologies including AI-enabled care.
AAPM&R recommends that CMS
support this development of new coding pathways for digital healthcare.
* * * * *
Thank you for your consideration of our comments. If you have any questions
or would like more information regarding any of the recommendations offered
above, please contact AAPM&R Senior Director of Practice, Reimbursement,
and Regulatory Affairs, Carolyn Millet, at
cmillett@aapmr.org
or (847) 737-6024.
Sincerely,
Susan L. Hubbell, MD, MS, FAAPMR
Chair, Health Policy, Practice, and Advocacy Committee
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2344-1521
August 31, 2026
The Honorable Mehmet Oz, MD, MBA
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attn: CMS-1850-P
7500 Security Boulevard
Baltimore, MD 21244
RE: Medicare Program: Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems; and Quality Reporting
Programs; Including the Hospital Outpatient Quality Reporting Program ... Show Full Article WASHINGTON, Sept. 2 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 31, 2026 The Honorable Mehmet Oz, MD, MBA Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attn: CMS-1850-P 7500 Security Boulevard Baltimore, MD 21244 RE: Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Programand
Ambulatory Surgical Center Quality Program [CMS-1850-P]
Dear Administrator Oz:
On behalf of the more than 9,000 physiatrists of the American Academy of
Physical Medicine and Rehabilitation (AAPM&R), we appreciate the
opportunity to submit comments to the Centers for Medicare & Medicaid
Services (CMS) in response to the Calendar Year (CY) 2026 Medicare
Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical
Center (ASC) Payment System proposed rule referenced above. AAPM&R is the
national medical specialty organization representing physicians who are
specialists in physical medicine and rehabilitation (PM&R). PM&R physicians,
also known as physiatrists, treat a wide variety of medical conditions affecting
the brain, spinal cord, nerves, bones, joints, ligaments, muscles, and tendons.
PM&R physicians evaluate and treat injuries, illnesses, and disability and are
experts in designing comprehensive, patient-centered treatment plans.
Physiatrists utilize cutting-edge as well as time-tested treatments to maximize
function and quality of life.
Expansion of Botulinum Toxin Injection Codes for Hospital
Outpatient Department (OPD) Prior Authorization Processes
CMS proposes to expand prior authorization requirements under the Hospital
Outpatient Department (OPD) prior authorization process to include eight
additional botulinum toxin injection codes, effective for services provided on
or after July 1, 2027.
AAPM&R has significant concerns with this proposal
and urges CMS not to finalize the addition of the new botulinum toxin
codes.
We commend CMS for its efforts to identify fraud and abuse and preserve the
integrity and sustainability of the Medicare program. At the same time,
program-integrity measures should be carefully targeted to areas in which
evidence demonstrates a meaningful risk of improper utilization, so that
efforts to prevent fraud do not inadvertently create barriers to timely, medically
necessary care.
Although isolated cases of fraud involving botulinum toxin have been reported,
we are unaware of evidence demonstrating meaningful fraud or abuse of
botulinum toxin procedure billing among PM&R physicians. Imposing prior
authorization broadly on these services would place substantial administrative
burden on the specialty that provides much of the nation's spasticity care
while risking treatment delays for particularly vulnerable patients with stroke,
traumatic brain injury, spinal cord injury, multiple sclerosis, cerebral palsy,
ALS, and other neurologic disabilities. Delays in the treatment of abnormal
muscle tone can result in pain, impaired function, and increased caregiver
burden, as well as potentially preventable complications such as joint
contractures and wounds; conditions that are far easier and less costly to
prevent than to treat once they occur.
CMS points to significant increases in utilization of botulinum toxin codes from
2017 through 2024 as a major justification for including these services under
the OPD prior authorization process.
We disagree that increased utilization
alone provides sufficient rationale to support this proposal.
To begin, as
CMS identifies, one factor contributing to this increased utilization is the
expansion of FDA-approved indications for the use of botulinum toxin products
that occurred over this period, which we do not believe should be discounted.
Importantly, we also note that a major contributor to increased botulinum toxin
utilization is a concerted effort in recent years across the rehabilitation
community to increase awareness of and treatment for spasticity, which is
effectively treated with botulinum toxin interventions. This effort is in response
to well-documented evidence of undertreatment for the condition
1,2
and the
associated patient burden.
3
Rather than reflecting fraud or abuse, we believe
1
Patel A, Gellhorn A, Neerukonda K, Kwasnica C. Multidisciplinary collaborative
consensus statement on the barriers and solutions to care access, patient and
caregiver support, and clinical capacity and capability for patients with spasticity. PM
R. 2
024 Mar;16(3):278-286
https://doi.org/10.1002/pmrj.13106
2
Baricich A, Wein T, Cinone N, Bertoni M, Picelli A, Chisari C, Molteni F, Santamato A.
BoNT-A for Post-Stroke Spasticity: Guidance on Unmet Clinical Needs from a Delphi
Panel Approach.
Toxins. 2021; 13(4):236.
https://doi.org/10.3390/toxins13040236
3
Patel A, Wein T, Bahroo L, et al. Burden of spasticity among patients and caregivers:
Results of a multinational survey. Neurology. 2019 Apr; 92(15 supplement) P5.6-019.
https://doi.org/10.1212/WNL.92.15_supplement.P5.6-019
that growth in utilization reflects the fact that more patients have been seeking
- and more physicians have been delivering - appropriate treatment for
spasticity over this time period. This is especially true for post-stroke patients,
for whom spasticity management has been prioritized given the incidence and
impact of spasticity in the population.
It is difficult to determine whether the prevalence of spasticity has increased
and may therefore be contributing to greater utilization of CPT codes 64642
and 64644. This uncertainty is compounded by the absence of a dedicated
ICD-10-CM code for spasticity, which limits our ability to reliably track its
prevalence and utilization of associated treatments. Recognizing this gap,
AAPM&R has proposed creation of a dedicated ICD-10-CM code for spasticity
and will present this proposal to the CDC's ICD-10-CM Coordination and
Maintenance Committee in September. We anticipate a new ICD-10-CM code
for spasticity could better document the medically appropriate nature of
botulinum toxin services.
Nevertheless, there are compelling reasons to expect that the number of
patients requiring treatment for spasticity has increased. Post-stroke spasticity
is a leading indication for botulinum toxin injections, and the population of
Americans living with the consequences of stroke has grown and is projected
to continue increasing, driven in part by an aging population, prevalence of risk
factors, and improved stroke survival
4
. Increased utilization of these services
should therefore not, in itself, be interpreted as evidence of inappropriate
utilization.
AAPM&R members have long expressed deep concerns with the outsized and
unnecessary administrative burden placed on physicians across the spectrum
of care, a burden that has only continued to grow in recent years with the
expansion of overly onerous prior authorization and utilization management
requirements. Far too much of a PM&R physician's time is currently spent
documenting medical necessity and meeting arbitrary timelines that often
bear little clinical relevance to quality medical treatment or outcomes for
patients. Data related to physician burnout clearly demonstrates the toll that
overly burdensome compliance requirements and other administrative
burdens place on physiatrists.
4
Park JH, Chang Y, Park S, Song TJ. Burden of stroke in the United States of America,
1990-2021: a systematic analysis for the US burden of disease study 2021. Front
Neurol. 2025;16:1609508. Published 2025 Aug 14. doi:10.3389/fneur.2025.1609508
(
Frontiers | Burden of stroke in the United States of America, 1990-2021: a systematic
analysis for the US burden of disease study 2021
)
The Regulatory Relief Coalition, a group of national physician specialty
organizations advocating for regulatory burden
reduction in Medicare so that
physicians can spend more time treating patients, conducted a survey
5
of
physicians on the impact that prior authorization has on their practices. The
survey found, among other things, that:
Eighty-two percent of respondents state that prior authorization
always (37%) or often (45%) delays access to necessary care;
Wait times can be lengthy:
For most physicians (74%), it takes
between 2 to 14 days to obtain prior authorization, and for 15%, this
process can take 15 to more than 31 days;
Thirty-two percent (32%) of respondents report that patients often
abandon treatment, and 50% report that patients sometimes
abandon treatment;
Overwhelmingly (87%), physicians report that prior authorization has
a significant (40%) or somewhat (47%) negative impact on patient
clinical outcomes; and
Ultimately, most services are approved, with one-third of physicians
getting approved 90% of the time or more.
To the extent that CMS is concerned about inappropriate utilization,
including potential fraud or abuse, AAPM&R recommends that CMS utilize
less burdensome tools to address potential overutilization rather than new
across-the-board prior authorization requirements as proposed.
This could
include expanded outreach and education, as well as use of targeted post-
claim review procedures for high-risk providers, including comparative billing
reports, Targeted Probe and Educate (TPE) reviews, and reviews by CMS
program integrity contractors. Such an approach would limit burden for
compliant providers and support appropriate access to medically necessary
care for the management of spasticity.
Given the excessive burdens that physicians are already facing from
unnecessary prior authorization practices,
AAPM&R does not believe that it
would be beneficial to patients or providers for CMS to expand prior
authorization requirements for OPD services to include additional
botulinum toxin injections.
5
RRC Prior Authorization Survey,
https://www.regrelief.org/wp-
content/uploads/2019/12/RRC-Prior-Authorization-Survey-Results-FINAL-7-26.pdf
OPPS Payments for Software as a Medical Services (SaMS)
Diagnostic Services
CMS discusses the increasing role of software-based technologies - including
artificial intelligence (AI) - to support clinical decision-making in the outpatient
and physician office settings and considers how to accommodate such
technologies in the Medicare program. As part of this effort, CMS proposes to
change the terminology it has been using from "Software as a Service" (SaaS)
to "Software as a Medical Service" (SaMS) in order to dispel ambiguity and
clarify the distinction between cloud-based computing service models that the
term SaaS often connotes and the software-based technologies that support
clinical decision making through algorithmic analysis that CMS is
contemplating. CMS also proposes to establish a dedicated but interim billing
pathway for algorithm-driven clinical software (e.g., AI and diagnostic tools)
that aid physician work, including assigning a new status indicator, O1, to
ensure separate, distinct APC payments.
AAPM&R supports the proposed
change in terminology and appreciates that CMS is pursuing efforts to
identify appropriate avenues for coverage and payment of SaMS furnished
in outpatient hospital and physician office settings.
We note that cost or affordability continues to be a significant barrier to
implementation of AI and other SaMS, including for physician practices and
hospital outpatient departments. These technologies require significant
investment of both time and financial resources without a guaranteed return
on investment. AAPM&R therefore appreciates thoughtful exploration of
Medicare reimbursement policy with respect to the range of SaMS
technologies, including AI.
As CMS contemplates how best to incorporate SaMS into Medicare payment
policy, we highlight that current reimbursement is limited for AI tools due to a
lack of a straightforward connection between AI and the current fee-for-service
payment structure. We recognize that the American Medical Association's
(AMA's) Current Procedural Terminology (CPT) Editorial Panel is working to
modernize the CPT code set to accommodate the range of rapidly emerging
technologies including AI-enabled care.
AAPM&R recommends that CMS
support this development of new coding pathways for digital healthcare.
* * * * *
Thank you for your consideration of our comments. If you have any questions
or would like more information regarding any of the recommendations offered
above, please contact AAPM&R Senior Director of Practice, Reimbursement,
and Regulatory Affairs, Carolyn Millet, at
cmillett@aapmr.org
or (847) 737-6024.
Sincerely,
Susan L. Hubbell, MD, MS, FAAPMR
Chair, Health Policy, Practice, and Advocacy Committee
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2344-1521
Association for Diagnostics & Laboratory Medicine: Healthcare Industry Voices Concerns Over CMS Proposal to Reimburse Software-Based Medical Analyses
Carter Struck
WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
August 20, 2026
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Baltimore, MD 21244-8010
Attention: CMS-1850-P
Dear Sir/Madam:
The Association for Diagnostics & Laboratory Medicine (ADLM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services' (CMS) July 7, 2026 proposed revisions to the Hospital Outpatient Prospective Payment System (OPPS) and Medicare ... Show Full Article WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 20, 2026 Centers for Medicare & Medicaid Services Department of Health and Human Services Baltimore, MD 21244-8010 Attention: CMS-1850-P Dear Sir/Madam: The Association for Diagnostics & Laboratory Medicine (ADLM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services' (CMS) July 7, 2026 proposed revisions to the Hospital Outpatient Prospective Payment System (OPPS) and MedicareAmbulatory Surgical Center (ASC) Payment System. Within the document the agency recommends the adoption of a new payment policy for software-based medical services used in algorithmic analyses. This provision is the focus of ADLM's comments.
CMS states that existing reimbursement policy for software as a medical service (SaMS) "may create significant vulnerabilities for the Medicare program" because these tests are paid under the Clinical Laboratory Fee Schedule (CLFS) and not "subject to beneficiary cost-sharing or budget neutrality." To address this concern, the agency asserts these services are not clinical diagnostic tests and therefore may be performed by non-CLIA certified entities, allowing CMS to remove them from the CLFS.
ADLM is concerned that this payment-driven approach does not adequately consider the regulatory implications or potential effects of this change on patient care. While we agree that the level of regulatory oversight for these algorithmic services warrants discussion, this payment rule is not the proper venue. ADLM recommends that CMS withdraw the proposal and engage the broader healthcare community in a dialogue on the appropriate regulatory model for these tests.
General Comments
In the proposed rule, CMS suggests that secondary analyses of test results may be performed by non-CLIA laboratories because specimen collection, quality control, testing, result generation, and interpretation have already occurred. CMS views subsequent use of those data to generate patient-care information as distinct from the laboratory testing process and outside CLIA oversight. ADLM believes this characterization is inaccurate as it fails to take into consideration
the laboratory's central role in this process. As CMS assesses this proposal, it should consider the following:
CMS
August 20, 2026
Page Two
All test results, even when measuring the same analyte, are not equivalent - many clinical laboratory results are not harmonized. Depending on the method or device used, laboratories may produce different numeric values and reference intervals for the same analyte. Although these results may be reproducible for a specific method, they may not be comparable across devices or platforms. Algorithms that combine or interpret data generated through different methodologies may increase the risk of misdiagnosis and lead to higher, rather than lower, healthcare costs. Many non-laboratorians are not familiar with this limitation.
Laboratory expertise remains essential to interpreting lab-generated data because laboratory physicians and scientists are best positioned to assess the strengths and limitations of test results - laboratory professionals use their knowledge of test methodologies, clinical context, and related results to identify aberrations or inconsistencies that algorithmic analysis alone may miss. If unrecognized, these issues can produce inaccurate or harmful outputs. Algorithms can support clinical decision-making, but they cannot replace informed laboratory judgment, particularly when preanalytical or analytical factors may affect downstream analysis or when non-harmonized data is employed.
Appropriate oversight of the data is needed to ensure the results are accurate and meaningful wherever they are generated - non-CLIA certified entities do not operate under the same quality standards that clinical laboratories use to ensure the integrity of the testing process, the accuracy of results, and the appropriateness of result interpretation. These safeguards are critical to generating reliable data. Treating all diagnostic data as equivalent, regardless of how it was produced, could lead to unsafe patient care decisions. Laboratorians understand these constraints, while non-laboratorians often are not aware of them or the clinical implications.
Proposed New Technology APC Codes CY 2027
In the proposal, CMS identifies several secondary analyses that it characterizes as non-clinical diagnostic tests, which do not need to be performed by a CLIA-certified laboratory. The agency suggests that once a test result is generated, subsequent computations using those data qualify as "other diagnostic tests" under section 1861(s)(3) of the Social Security Act and are not eligible for CLFS reimbursement.
A review of the data in Table 62 indicates that most analytical methods used for these tests are poorly harmonized, requiring laboratory expertise to align locally generated data with the model's training inputs. For example, digital-pathology morphology and stain intensity have no cross-scanner or cross-stain reference standard and shift measurably with tissue processing, staining, and scanner; most quantitative chemistry and immunoassays yield method-specific
CMS
August 20, 2026
Page Three
numeric values and reference intervals for the same measurand. In these cases, the computation is not separable from the examination; it is part of it, and the service meets the 493.2 definition of a CLIA laboratory. The image-analysis codes (0512U, 0513U, 0414U, 0418U, 0220U, 0376U) and the functional cell-culture assay (0511U) listed in Table 62 rely upon non-harmonized inputs and remain clinical diagnostic laboratory tests; 0510U is the exception.
Regulatory Oversight of Secondary Analyses
Clinical laboratories operate within a quality-focused regulatory framework designed to protect patients by ensuring that test results are accurate, reliable, and clinically meaningful. Separating algorithmic clinical decision-making from the upstream processes that generate the underlying data-without applying comparable quality management expectations-could increase the risk that patient care decisions are based on incomplete, inconsistent, or unreliable information.
If CMS wants to expand testing of secondary analyses to non-CLIA laboratories, it should first specify how these facilities will be regulated to ensure the accuracy, reliability, and appropriate use of these services, including how these data will be validated, meet quality control standards, monitor performance, report results, and provide meaningful interpretation. ADLM urges CMS to withdraw this provision from the proposed rule and address the oversight and patient care questions before moving forward with changes to the payment system.
Thank you for considering ADLM's comments. If you have any questions, please email Vince Stine, PhD, ADLM's Chief Policy Officer, at vstine@myadlm.org, or Evan Fortman, MPA, ADLM's Manager of Government Affairs, at efortman@myadlm.org.
Sincerely,
Stanley F. Lo, PhD, DABCC, FADLM
ADLM President
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2344-0748
August 20, 2026
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Baltimore, MD 21244-8010
Attention: CMS-1850-P
Dear Sir/Madam:
The Association for Diagnostics & Laboratory Medicine (ADLM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services' (CMS) July 7, 2026 proposed revisions to the Hospital Outpatient Prospective Payment System (OPPS) and Medicare ... Show Full Article WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 20, 2026 Centers for Medicare & Medicaid Services Department of Health and Human Services Baltimore, MD 21244-8010 Attention: CMS-1850-P Dear Sir/Madam: The Association for Diagnostics & Laboratory Medicine (ADLM) appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services' (CMS) July 7, 2026 proposed revisions to the Hospital Outpatient Prospective Payment System (OPPS) and MedicareAmbulatory Surgical Center (ASC) Payment System. Within the document the agency recommends the adoption of a new payment policy for software-based medical services used in algorithmic analyses. This provision is the focus of ADLM's comments.
CMS states that existing reimbursement policy for software as a medical service (SaMS) "may create significant vulnerabilities for the Medicare program" because these tests are paid under the Clinical Laboratory Fee Schedule (CLFS) and not "subject to beneficiary cost-sharing or budget neutrality." To address this concern, the agency asserts these services are not clinical diagnostic tests and therefore may be performed by non-CLIA certified entities, allowing CMS to remove them from the CLFS.
ADLM is concerned that this payment-driven approach does not adequately consider the regulatory implications or potential effects of this change on patient care. While we agree that the level of regulatory oversight for these algorithmic services warrants discussion, this payment rule is not the proper venue. ADLM recommends that CMS withdraw the proposal and engage the broader healthcare community in a dialogue on the appropriate regulatory model for these tests.
General Comments
In the proposed rule, CMS suggests that secondary analyses of test results may be performed by non-CLIA laboratories because specimen collection, quality control, testing, result generation, and interpretation have already occurred. CMS views subsequent use of those data to generate patient-care information as distinct from the laboratory testing process and outside CLIA oversight. ADLM believes this characterization is inaccurate as it fails to take into consideration
the laboratory's central role in this process. As CMS assesses this proposal, it should consider the following:
CMS
August 20, 2026
Page Two
All test results, even when measuring the same analyte, are not equivalent - many clinical laboratory results are not harmonized. Depending on the method or device used, laboratories may produce different numeric values and reference intervals for the same analyte. Although these results may be reproducible for a specific method, they may not be comparable across devices or platforms. Algorithms that combine or interpret data generated through different methodologies may increase the risk of misdiagnosis and lead to higher, rather than lower, healthcare costs. Many non-laboratorians are not familiar with this limitation.
Laboratory expertise remains essential to interpreting lab-generated data because laboratory physicians and scientists are best positioned to assess the strengths and limitations of test results - laboratory professionals use their knowledge of test methodologies, clinical context, and related results to identify aberrations or inconsistencies that algorithmic analysis alone may miss. If unrecognized, these issues can produce inaccurate or harmful outputs. Algorithms can support clinical decision-making, but they cannot replace informed laboratory judgment, particularly when preanalytical or analytical factors may affect downstream analysis or when non-harmonized data is employed.
Appropriate oversight of the data is needed to ensure the results are accurate and meaningful wherever they are generated - non-CLIA certified entities do not operate under the same quality standards that clinical laboratories use to ensure the integrity of the testing process, the accuracy of results, and the appropriateness of result interpretation. These safeguards are critical to generating reliable data. Treating all diagnostic data as equivalent, regardless of how it was produced, could lead to unsafe patient care decisions. Laboratorians understand these constraints, while non-laboratorians often are not aware of them or the clinical implications.
Proposed New Technology APC Codes CY 2027
In the proposal, CMS identifies several secondary analyses that it characterizes as non-clinical diagnostic tests, which do not need to be performed by a CLIA-certified laboratory. The agency suggests that once a test result is generated, subsequent computations using those data qualify as "other diagnostic tests" under section 1861(s)(3) of the Social Security Act and are not eligible for CLFS reimbursement.
A review of the data in Table 62 indicates that most analytical methods used for these tests are poorly harmonized, requiring laboratory expertise to align locally generated data with the model's training inputs. For example, digital-pathology morphology and stain intensity have no cross-scanner or cross-stain reference standard and shift measurably with tissue processing, staining, and scanner; most quantitative chemistry and immunoassays yield method-specific
CMS
August 20, 2026
Page Three
numeric values and reference intervals for the same measurand. In these cases, the computation is not separable from the examination; it is part of it, and the service meets the 493.2 definition of a CLIA laboratory. The image-analysis codes (0512U, 0513U, 0414U, 0418U, 0220U, 0376U) and the functional cell-culture assay (0511U) listed in Table 62 rely upon non-harmonized inputs and remain clinical diagnostic laboratory tests; 0510U is the exception.
Regulatory Oversight of Secondary Analyses
Clinical laboratories operate within a quality-focused regulatory framework designed to protect patients by ensuring that test results are accurate, reliable, and clinically meaningful. Separating algorithmic clinical decision-making from the upstream processes that generate the underlying data-without applying comparable quality management expectations-could increase the risk that patient care decisions are based on incomplete, inconsistent, or unreliable information.
If CMS wants to expand testing of secondary analyses to non-CLIA laboratories, it should first specify how these facilities will be regulated to ensure the accuracy, reliability, and appropriate use of these services, including how these data will be validated, meet quality control standards, monitor performance, report results, and provide meaningful interpretation. ADLM urges CMS to withdraw this provision from the proposed rule and address the oversight and patient care questions before moving forward with changes to the payment system.
Thank you for considering ADLM's comments. If you have any questions, please email Vince Stine, PhD, ADLM's Chief Policy Officer, at vstine@myadlm.org, or Evan Fortman, MPA, ADLM's Manager of Government Affairs, at efortman@myadlm.org.
Sincerely,
Stanley F. Lo, PhD, DABCC, FADLM
ADLM President
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2344-0748
American Association of Nurse Anesthesiology: CMS Urged to Remove Physician Supervision Requirements for CRNAs to Address Anesthesia Access Crisis
Carter Struck
WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
August 19, 2026
Dr. Mehmet Oz, M.D.
Administrator
Centers for Medicare and Medicaid Services (CMS)
7500 Security Blvd
Baltimore, MD 21244
Submitted electronically at https://www.regulations.gov/commenton/CMS-2026-2344-0002
Administrator Oz:
On behalf of the more than 69,000 members of the American Association of Nurse Anesthesiology (AANA) I submit these comments in response to the Calendar Year 2027 Medicare and ... Show Full Article WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 19, 2026 Dr. Mehmet Oz, M.D. Administrator Centers for Medicare and Medicaid Services (CMS) 7500 Security Blvd Baltimore, MD 21244 Submitted electronically at https://www.regulations.gov/commenton/CMS-2026-2344-0002 Administrator Oz: On behalf of the more than 69,000 members of the American Association of Nurse Anesthesiology (AANA) I submit these comments in response to the Calendar Year 2027 Medicare andMedicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Proposed Rule (hereafter OPPS).
AANA is the professional association representing Certified Registered Nurse Anesthetists (CRNAs) and Student Registered Nurse Anesthetists (SRNAs) nationwide. CRNAs are Advanced Practice Registered Nurses (APRNs) who are doctorally prepared autonomous anesthesia providers through their training and preparation. CRNAs provide expert anesthesia and pain management care across diverse clinical settings and are trained and licensed to care for all patients, including those with complex medical conditions. In some states, CRNAs are the sole anesthesia providers in nearly 100 percent of rural hospitals, affording these medical facilities obstetrical, surgical, trauma stabilization, and pain management capabilities.
AANA welcomes the opportunity to provide feedback on policies in the OPPS that impact CRNAs and the patients and facilities they serve. In these comments we address:
1.
CMS must remove the physician supervision requirements for CRNAs, address anesthesia reimbursement, and ensure Ambulatory Surgery Centers are properly reimbursed.
2.
CMS' phase out of the IPO list should be led by a specified evidence-based review.
3.
CMS's continued investment in non-opioid treatments for pain relief is vital, but CMS must include direct clinician reimbursement.
4.
AANA applauds CMS's continued support of access to Esketamine treatment.
5.
Software as a Medical Service payment policy must support requirements that include clinician decision-making protections.
6.
CMS must ensure payment policy for domestic Personal Protective Equipment and essential medicines considers the needs of anesthesia care.
7.
If finalized, CMS should modify the Advance Care Planning eCQM for the hospital outpatient setting and provide implementation guidance that reflects the roles of outpatient specialists and procedural providers.
8.
If finalized, CMS should ensure phase-of-care stratification of the All-Cause Transfer/Admission measure improves attribution, incorporates appropriate safeguards, and avoids unintended consequences for anesthesia providers.
1.
CMS must remove the physician supervision requirements for CRNAs, address anesthesia reimbursement, and ensure Ambulatory Surgery Centers are properly reimbursed.
AANA urges CMS to stabilize anesthesia care delivery by eliminating the wasteful physician supervision requirements and ensuring anesthesia and outpatient facility reimbursement responds to the realities of care delivery. AANA is deeply concerned with the mounting anesthesia crisis in the Medicare program. The demand for anesthesia care is rising while the country continues to face provider shortages. The impact of years of a declining anesthesia reimbursement rate, undervaluing of chronic pain management care, and continuation of the burdensome physician supervision requirement for CRNAs as part of the Hospital, Critical Access Hospital, and Rural Emergency Hospital Conditions of Participation (CoPs), and the Ambulatory Surgical Center Conditions for Coverage (CfCs) is contributing to facility closures and growing anesthesia access care gaps.
Additionally, outpatient facilities, especially ambulatory surgery centers (ASCs) and those in rural communities, are vital for care access yet also bear the brunt of the underpayment for anesthesia care. It is predicted that outpatient volumes will grow 20 percent over the next 10 years with a large shift toward more efficient ambulatory settings.
1
Vizient, 2026 Impact of Change Forecast, June 2026, available at: https://vizientinc-delivery.sitecorecontenthub.cloud/api/public/content/d68f76ac86a74bc286889f37eba3d3fb.
2
KNG Health Consulting, Medicare Savings from Use of Ambulatory Surgery Centers, 2019-2024, May 6, 2026, available at: https://www.ascassociation.org/asca/about-ascs/savings/medicare-savings-from-use-of-ambulatory-surgery-centers.
ASCs and CRNAs represent efficient, effective, and safe care delivery. ASCs are proven cost savers for Medicare programs.
2
CRNAs are not only essential care providers for rural areas as 80 percent of rural counties rely on CRNAs as their primary anesthesia care providers, but ASCs overwhelmingly utilize CRNA led care teams due to the efficiency of CRNA-only anesthesia models.
3
However, many ASCs are prevented from using the CRNA only model if they reside in a state that has not yet gone through the onerous process to opt-out of the physician supervision requirements. To date, 27 states have opted out of these policies while the majority of states, 45, do not have any physician supervision requirements of CRNAs in their nursing/medicine laws or rules. Evidence continues to overwhelmingly show that autonomously practicing CRNAs are safe and effective clinicians with no increase in negative patient outcomes.
4
Research also shows that when CRNAs are able to practice to the full extent of their education and training without physician supervision requirements, this expands access to anesthesia care.
5
We therefore strongly recommend CMS remove the wasteful and burdensome physician supervision requirements for CRNAs. They are not based on any evidence and only contribute waste to the Medicare program. Removal of these policies will also boost the capabilities of ASCs which are vital to the future of outpatient care, but CMS must ensure ASC payment policies also support their growth and sustainability. We strongly support the continuation of applying the hospital market basket update to ASC rates for an additional year and urge CMS to make this policy permanent.
2.
CMS' phase out of the IPO list should be led by a specified evidence-based review.
In the proposed rule, CMS continues its second year of the three-year phase out of the inpatient only (IPO) list. AANA remains concerned with CMS' process to eliminate the IPO list as it does not rely on an individualized evidence-based review. While we do support the transfer of appropriate services to outpatient settings and the reliance on clinician decision making for proper site of service, we still caution that the current process could have unintended consequences. This is especially important as CMS notes in this year's proposed rule that the remaining procedures on the IPO list set to be removed in CY 2028 are complex procedures requiring extra review. Appropriate site of service must depend on patient selection criteria that determines risk based on
3
American Association of Nurse Anesthesiology, CRNAs are the Most Versatile and Cost-Effective Anesthesia Providers, Updated January 2025, available at: https://www.aana.com/wp-content/uploads/2023/02/CRNA-Cost-Effective-General-AANA-2025.pdf.
4
NegrusaB., et al., Scope of practice laws and anesthesia complications: No measurable impact of certified registered nurse anesthetist expanded scope of practice on anesthesia-related complications, Medical Care, June 2016, available at: http://journals.lww.com/lww-medicalcare/Abstract/publishahead/Scope_of_Practice_Laws_and_Anesthesia.98905.aspx; Dulisse B., et al., No Harm Found When Nurse Anesthetists Work Without Supervision by Physicians, Health Affairs, August 2010, available at: https://www.healthaffairs.org/doi/10.1377/hlthaff.2008.0966; Lewis SR, et al., Physician anesthetists versus non-physician providers of anesthesia for surgical patients, Cochrane Database of Systematic Reviews, July 2014, available at: https://pubmed.ncbi.nlm.nih.gov/25019298/.
5
Ghosh, PP, et al., Impact of Scope of Practice Laws for Certified Registered Nurse Anesthetists on the Utilization of Anesthesia Services, Health Services Research, October 2025, available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC12857518/.
patient comorbidities as this is the critical factor in determining suitability in the outpatient setting.
While being cognizant of not imposing arduous barriers to care, we urge CMS to establish an approach that ensures the necessary evidence review of patient selection criteria for IPO list procedures before their transition to the outpatient setting.
3.
CMS's continued investment in non-opioid treatments for pain relief is vital, but CMS must include direct clinician reimbursement.
AANA remains committed to opioid-sparing techniques which are critical to the future of anesthesia care. CRNAs are important leaders in this area due to being the primary providers in rural communities that remain at the highest risk of opioid-use disorders, often evolving from chronic use after surgery.
6
CRNAs are highly skilled in chronic pain management utilizing holistic methods such as Enhanced Recovery After Surgery (ERAS) pathways.
7
ERAS is a patient-centered, evidence-based, pain management strategy employed by CRNAs to reduce the need for opioids, improve patient outcomes, and reduce costs.
CMS' continuing additional payments is a critical investment in these life-saving advancements. AANA agrees with the proposal that a more often quarterly review of non-opioid treatments will ensure timely advancements. Importantly, CMS must include separate clinician payments under the Physician Fee Schedule to ensure the continued advancement of these safer and more effective techniques. By limiting additional investments to only facilities and not extending to clinicians directly, it suppresses further innovation by CRNAs who are leading the actual implementation of these techniques in the rural communities that need them the most.
4.
AANA applauds CMS's continued support of access to Esketamine treatment.
AANA supports CMS' proposal to increase Esketamine payments reflecting most recent available utilization data. As stated in our comments on last year's proposed rule, Esketamine treatment is a critical service for treatment resistant major depressive disorder and other mental health conditions. CRNAs provide ketamine therapy for mental health treatments within an interdisciplinary team alongside psychiatric clinicians such as psychiatric-mental health nurses.
8
CRNAs are a growing workforce in this area that provide all methods of ketamine administration, including Esketamine. AANA supports CMS' increase based on analysis of most recent available claims data that led to updating for CY 2027 HCPCS code G2082 being assigned to APC 1513 (New Technology-Level 13) with a payment rate of $1,150.50 and HCPCS code G2083 being assigned to APC 1518 (New Technology-Level 18) with a payment rate of $1,650.50. AANA urges CMS to ensure the continued proper reimbursement for this service as a critical investment in mental health care.
5.
Software as a Medical Service payment policy must support requirements that include clinician decision-making protections.
CMS's approach to standardizing Software as a Medical Service (SaMS) payments by testing them for CY 2027 as New Technology APCs with status indicator "01" will be beneficial to expand access to efficient evolving technologies. Applicable HCPCS codes designated as SaMS for CY 2027 in Table 61 include important clinician review and interpretation requirements, as well as inclusive provider type language, which must remain central factors for clinical and payment policy. Especially as CMS and the entire Department of Health and Human Services (HHS) investigate best pathways to incorporate rapidly evolving Artificial Intelligence (AI) technologies, we urge that there be careful attention to these tools supporting but never replacing CRNA clinical decision-making and expertise.
9
6.
CMS must ensure payment policy for domestic Personal Protective Equipment and essential medicines considers the needs of anesthesia care.
AANA appreciates the request for information on domestic Personal Protective Equipment (PPE) and essential medicines and strongly supports separate payment for these supplies. Supply chain shortages and rising costs of medicines and supplies fall especially on small hospitals, rural hospitals, and ASCs as they all run extremely tight margins. Recent shortages of IV fluids were deeply felt in these facilities and communities. We therefore stress that anesthesia drugs must be included on any lists of essential medicines.
While AANA wholly supports the domestic production and supply of PPE and medicines, anesthesia drugs required across the perioperative continuum require flexibilities for emergencies. In previous circumstances the Food and Drug Administration (FDA) has conducted emergency inspections of foreign facilities to
https://issuu.com/aanapublishing/docs/7-_ketamine_infusion_therapy_for_psychiatric_diso?fr=sNTFhMjU2NDAxMjU.
9
For more on this topic see AANA Comments on HHS Request for Information: Accelerating the Adoption and Use of Artificial Intelligence as Part of Clinical Care [RIN 0955-AA13], February 18, 2026, available at: https://www.aana.com/wp-content/uploads/2026/02/AANA-Comment-Letter-responding-to-the-Department-of-Health-Human-Services-Request-for-Information.pdf.
allow temporary importation of foreign drugs in critical shortages such as Propoven, the European version of Propofol. Additionally, payment structure must match clinical realities such as correct vial sizes of Propofol, which is single use but 100mL vials do not match every case, such as pediatric cases, and therefore creates unnecessary waste. We propose CMS continue to conduct stakeholder input events to gather more specialty specific information and strongly recommend utilizing CRNA expertise to ensure anesthesia care is fully incorporated in PPE and essential medicine supply chain planning.
7.
If finalized, CMS should modify the Advance Care Planning eCQM for the hospital outpatient setting and provide implementation guidance that reflects the roles of outpatient specialists and procedural providers.
AANA applauds CMS' efforts to advance person-centered care by exploring the inclusion of an Advance Care Planning (ACP) eCQM within the Hospital OQR Program. Advance care planning is an important component of high-quality care, particularly for patients with serious illness or those undergoing high-risk procedures. However, we encourage CMS to carefully consider how responsibility for this measure is attributed within the hospital outpatient setting. Advance care planning is typically initiated and maintained by primary care providers or attending physicians who have an ongoing longitudinal relationship with the patient. By contrast, hospital outpatient clinicians such as surgeons, certified registered nurse anesthetists, and other specialists often have limited encounters that are focused on a specific procedure or episode of care. If the measure is attributed to outpatient procedural providers or specialists, we believe the current measure specifications would require modification to reflect their role in the continuum of care.
Specifically, CMS should clarify whether the expectation is for outpatient providers to initiate new advance care planning discussions, verify the presence of existing documentation, update existing documents, or simply document that advance care planning was addressed. Without clearly defining provider responsibilities, implementation may create duplicative documentation requirements and administrative burden without meaningfully improving patient-centered care.
We also note that the proposed measure includes no exclusions and applies to all adults aged 18 years and older. While advance care planning is beneficial for all adults, implementation may present unique challenges among younger populations, particularly patients aged 18 to 35 years, where advance directives and related documentation are less common. We implore CMS to provide additional information on strategies that facilities could use to increase advance care planning engagement among younger adults and whether alternative implementation approaches or risk-adjusted benchmarks should be considered for this population.
We encourage CMS to work closely with stakeholders, including CRNAs, during measure development to ensure that any future outpatient ACP measure is feasible to implement, appropriately attributed, and designed to improve meaningful patient engagement rather than solely increasing documentation.
8.
If finalized, CMS should ensure phase-of-care stratification of the All-Cause Transfer/Admission measure improves attribution, incorporates appropriate safeguards, and avoids unintended consequences for anesthesia providers.
AANA supports CMS' efforts to improve the usefulness and interpretation of the All-Cause Transfer/Admission measure through potential phase-of-care stratification. Stratifying transfers into pre-procedure, intra-procedure, and post-procedure categories has the potential to provide a more accurate understanding of when and why transfers occur and improve attribution of quality outcomes across the ASC setting. A phase-of-care approach could help distinguish transfers identified during pre-procedure evaluation from those related to intraoperative or postoperative events. This distinction is particularly important for recognizing the role of CRNAs, in identifying high-risk patients and facilitating appropriate escalation of care before a procedure begins. Transfers resulting from anesthesia-led preoperative assessments may represent effective patient safety practices rather than adverse outcomes associated with anesthesia care.
However, CMS should ensure that any future stratification methodology includes appropriate definitions, risk adjustment, and safeguards to prevent unintended consequences. Without careful measure design, more granular reporting could lead to misattribution of transfers to anesthesia providers or anesthesia services, particularly for events driven by patient complexity, underlying medical conditions, or appropriate clinical decision-making.
Additionally, phase-specific transfer data may eventually be considered by payers, facilities, or policymakers in quality evaluations, value-based arrangements, or contracting decisions. CMS should ensure that such data are not used to compare anesthesia providers or anesthesia delivery models without accounting for important differences, including:
Patient acuity and complexity.
Case mix and procedure types.
Facility resources and capabilities.
Availability of emergency support and hospital resources.
Differences in populations served, including rural and underserved communities.
We also recommend that CMS carefully consider the data sources used to identify and attribute transfers. If claims-based methodologies are used, CMS should ensure accurate attribution through appropriate diagnosis codes, CPT codes, and modifiers, including those associated with anesthesia services, to avoid inaccurate assignment of outcomes to providers.
Finally, CMS should carefully define the time anchors used for stratification. We recommend using procedure start and stop times, rather than anesthesia start and stop times, as the primary reference point for categorizing transfers. While many ASC procedures involve anesthesia services, not all procedures require anesthesia. Some procedures may be performed under local anesthesia or with sedation administered by other qualified clinical staff. Using anesthesia start and stop times could exclude certain ASC procedures and limit the completeness and comparability of the measure. We further request that CMS clarify that procedure start and stop times are intended solely for measure calculation and should not be used as a basis for determining anesthesia coverage, payment, or reimbursement. This clarification is particularly important given that some insurers have attempted to impose arbitrary time limits on anesthesia coverage and payment based on procedure times, which may not accurately reflect the time or resources required to provide anesthesia services.
Overall, we agree that the All-Cause Transfer/Admission measure is an important quality and patient safety measure, and additional stratification may improve its clinical relevance. However, successful implementation will require clear definitions, appropriate risk adjustment, accurate attribution, and consideration of the diverse clinical settings and anesthesia delivery models represented within ASCs.
Thank you for your time and attention to the critical role of CRNAs in our nation's healthcare workforce and the Medicare program. Should you have any questions or need to request a meeting please contact Romy Gelb-Zimmer, Director of Regulatory Affairs, at rgelb-zimmer@aana.com or Emily Champlin, Associate Director of Regulatory Affairs at echamplin@aana.com.
Sincerely,
Jeffrey E. Molter CRNA, MSN, MBA
AANA President
CC: William Bruce, MBA, AANA Chief Executive Officer
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2344-0734
August 19, 2026
Dr. Mehmet Oz, M.D.
Administrator
Centers for Medicare and Medicaid Services (CMS)
7500 Security Blvd
Baltimore, MD 21244
Submitted electronically at https://www.regulations.gov/commenton/CMS-2026-2344-0002
Administrator Oz:
On behalf of the more than 69,000 members of the American Association of Nurse Anesthesiology (AANA) I submit these comments in response to the Calendar Year 2027 Medicare and ... Show Full Article WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 19, 2026 Dr. Mehmet Oz, M.D. Administrator Centers for Medicare and Medicaid Services (CMS) 7500 Security Blvd Baltimore, MD 21244 Submitted electronically at https://www.regulations.gov/commenton/CMS-2026-2344-0002 Administrator Oz: On behalf of the more than 69,000 members of the American Association of Nurse Anesthesiology (AANA) I submit these comments in response to the Calendar Year 2027 Medicare andMedicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Proposed Rule (hereafter OPPS).
AANA is the professional association representing Certified Registered Nurse Anesthetists (CRNAs) and Student Registered Nurse Anesthetists (SRNAs) nationwide. CRNAs are Advanced Practice Registered Nurses (APRNs) who are doctorally prepared autonomous anesthesia providers through their training and preparation. CRNAs provide expert anesthesia and pain management care across diverse clinical settings and are trained and licensed to care for all patients, including those with complex medical conditions. In some states, CRNAs are the sole anesthesia providers in nearly 100 percent of rural hospitals, affording these medical facilities obstetrical, surgical, trauma stabilization, and pain management capabilities.
AANA welcomes the opportunity to provide feedback on policies in the OPPS that impact CRNAs and the patients and facilities they serve. In these comments we address:
1.
CMS must remove the physician supervision requirements for CRNAs, address anesthesia reimbursement, and ensure Ambulatory Surgery Centers are properly reimbursed.
2.
CMS' phase out of the IPO list should be led by a specified evidence-based review.
3.
CMS's continued investment in non-opioid treatments for pain relief is vital, but CMS must include direct clinician reimbursement.
4.
AANA applauds CMS's continued support of access to Esketamine treatment.
5.
Software as a Medical Service payment policy must support requirements that include clinician decision-making protections.
6.
CMS must ensure payment policy for domestic Personal Protective Equipment and essential medicines considers the needs of anesthesia care.
7.
If finalized, CMS should modify the Advance Care Planning eCQM for the hospital outpatient setting and provide implementation guidance that reflects the roles of outpatient specialists and procedural providers.
8.
If finalized, CMS should ensure phase-of-care stratification of the All-Cause Transfer/Admission measure improves attribution, incorporates appropriate safeguards, and avoids unintended consequences for anesthesia providers.
1.
CMS must remove the physician supervision requirements for CRNAs, address anesthesia reimbursement, and ensure Ambulatory Surgery Centers are properly reimbursed.
AANA urges CMS to stabilize anesthesia care delivery by eliminating the wasteful physician supervision requirements and ensuring anesthesia and outpatient facility reimbursement responds to the realities of care delivery. AANA is deeply concerned with the mounting anesthesia crisis in the Medicare program. The demand for anesthesia care is rising while the country continues to face provider shortages. The impact of years of a declining anesthesia reimbursement rate, undervaluing of chronic pain management care, and continuation of the burdensome physician supervision requirement for CRNAs as part of the Hospital, Critical Access Hospital, and Rural Emergency Hospital Conditions of Participation (CoPs), and the Ambulatory Surgical Center Conditions for Coverage (CfCs) is contributing to facility closures and growing anesthesia access care gaps.
Additionally, outpatient facilities, especially ambulatory surgery centers (ASCs) and those in rural communities, are vital for care access yet also bear the brunt of the underpayment for anesthesia care. It is predicted that outpatient volumes will grow 20 percent over the next 10 years with a large shift toward more efficient ambulatory settings.
1
Vizient, 2026 Impact of Change Forecast, June 2026, available at: https://vizientinc-delivery.sitecorecontenthub.cloud/api/public/content/d68f76ac86a74bc286889f37eba3d3fb.
2
KNG Health Consulting, Medicare Savings from Use of Ambulatory Surgery Centers, 2019-2024, May 6, 2026, available at: https://www.ascassociation.org/asca/about-ascs/savings/medicare-savings-from-use-of-ambulatory-surgery-centers.
ASCs and CRNAs represent efficient, effective, and safe care delivery. ASCs are proven cost savers for Medicare programs.
2
CRNAs are not only essential care providers for rural areas as 80 percent of rural counties rely on CRNAs as their primary anesthesia care providers, but ASCs overwhelmingly utilize CRNA led care teams due to the efficiency of CRNA-only anesthesia models.
3
However, many ASCs are prevented from using the CRNA only model if they reside in a state that has not yet gone through the onerous process to opt-out of the physician supervision requirements. To date, 27 states have opted out of these policies while the majority of states, 45, do not have any physician supervision requirements of CRNAs in their nursing/medicine laws or rules. Evidence continues to overwhelmingly show that autonomously practicing CRNAs are safe and effective clinicians with no increase in negative patient outcomes.
4
Research also shows that when CRNAs are able to practice to the full extent of their education and training without physician supervision requirements, this expands access to anesthesia care.
5
We therefore strongly recommend CMS remove the wasteful and burdensome physician supervision requirements for CRNAs. They are not based on any evidence and only contribute waste to the Medicare program. Removal of these policies will also boost the capabilities of ASCs which are vital to the future of outpatient care, but CMS must ensure ASC payment policies also support their growth and sustainability. We strongly support the continuation of applying the hospital market basket update to ASC rates for an additional year and urge CMS to make this policy permanent.
2.
CMS' phase out of the IPO list should be led by a specified evidence-based review.
In the proposed rule, CMS continues its second year of the three-year phase out of the inpatient only (IPO) list. AANA remains concerned with CMS' process to eliminate the IPO list as it does not rely on an individualized evidence-based review. While we do support the transfer of appropriate services to outpatient settings and the reliance on clinician decision making for proper site of service, we still caution that the current process could have unintended consequences. This is especially important as CMS notes in this year's proposed rule that the remaining procedures on the IPO list set to be removed in CY 2028 are complex procedures requiring extra review. Appropriate site of service must depend on patient selection criteria that determines risk based on
3
American Association of Nurse Anesthesiology, CRNAs are the Most Versatile and Cost-Effective Anesthesia Providers, Updated January 2025, available at: https://www.aana.com/wp-content/uploads/2023/02/CRNA-Cost-Effective-General-AANA-2025.pdf.
4
NegrusaB., et al., Scope of practice laws and anesthesia complications: No measurable impact of certified registered nurse anesthetist expanded scope of practice on anesthesia-related complications, Medical Care, June 2016, available at: http://journals.lww.com/lww-medicalcare/Abstract/publishahead/Scope_of_Practice_Laws_and_Anesthesia.98905.aspx; Dulisse B., et al., No Harm Found When Nurse Anesthetists Work Without Supervision by Physicians, Health Affairs, August 2010, available at: https://www.healthaffairs.org/doi/10.1377/hlthaff.2008.0966; Lewis SR, et al., Physician anesthetists versus non-physician providers of anesthesia for surgical patients, Cochrane Database of Systematic Reviews, July 2014, available at: https://pubmed.ncbi.nlm.nih.gov/25019298/.
5
Ghosh, PP, et al., Impact of Scope of Practice Laws for Certified Registered Nurse Anesthetists on the Utilization of Anesthesia Services, Health Services Research, October 2025, available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC12857518/.
patient comorbidities as this is the critical factor in determining suitability in the outpatient setting.
While being cognizant of not imposing arduous barriers to care, we urge CMS to establish an approach that ensures the necessary evidence review of patient selection criteria for IPO list procedures before their transition to the outpatient setting.
3.
CMS's continued investment in non-opioid treatments for pain relief is vital, but CMS must include direct clinician reimbursement.
AANA remains committed to opioid-sparing techniques which are critical to the future of anesthesia care. CRNAs are important leaders in this area due to being the primary providers in rural communities that remain at the highest risk of opioid-use disorders, often evolving from chronic use after surgery.
6
CRNAs are highly skilled in chronic pain management utilizing holistic methods such as Enhanced Recovery After Surgery (ERAS) pathways.
7
ERAS is a patient-centered, evidence-based, pain management strategy employed by CRNAs to reduce the need for opioids, improve patient outcomes, and reduce costs.
CMS' continuing additional payments is a critical investment in these life-saving advancements. AANA agrees with the proposal that a more often quarterly review of non-opioid treatments will ensure timely advancements. Importantly, CMS must include separate clinician payments under the Physician Fee Schedule to ensure the continued advancement of these safer and more effective techniques. By limiting additional investments to only facilities and not extending to clinicians directly, it suppresses further innovation by CRNAs who are leading the actual implementation of these techniques in the rural communities that need them the most.
4.
AANA applauds CMS's continued support of access to Esketamine treatment.
AANA supports CMS' proposal to increase Esketamine payments reflecting most recent available utilization data. As stated in our comments on last year's proposed rule, Esketamine treatment is a critical service for treatment resistant major depressive disorder and other mental health conditions. CRNAs provide ketamine therapy for mental health treatments within an interdisciplinary team alongside psychiatric clinicians such as psychiatric-mental health nurses.
8
CRNAs are a growing workforce in this area that provide all methods of ketamine administration, including Esketamine. AANA supports CMS' increase based on analysis of most recent available claims data that led to updating for CY 2027 HCPCS code G2082 being assigned to APC 1513 (New Technology-Level 13) with a payment rate of $1,150.50 and HCPCS code G2083 being assigned to APC 1518 (New Technology-Level 18) with a payment rate of $1,650.50. AANA urges CMS to ensure the continued proper reimbursement for this service as a critical investment in mental health care.
5.
Software as a Medical Service payment policy must support requirements that include clinician decision-making protections.
CMS's approach to standardizing Software as a Medical Service (SaMS) payments by testing them for CY 2027 as New Technology APCs with status indicator "01" will be beneficial to expand access to efficient evolving technologies. Applicable HCPCS codes designated as SaMS for CY 2027 in Table 61 include important clinician review and interpretation requirements, as well as inclusive provider type language, which must remain central factors for clinical and payment policy. Especially as CMS and the entire Department of Health and Human Services (HHS) investigate best pathways to incorporate rapidly evolving Artificial Intelligence (AI) technologies, we urge that there be careful attention to these tools supporting but never replacing CRNA clinical decision-making and expertise.
9
6.
CMS must ensure payment policy for domestic Personal Protective Equipment and essential medicines considers the needs of anesthesia care.
AANA appreciates the request for information on domestic Personal Protective Equipment (PPE) and essential medicines and strongly supports separate payment for these supplies. Supply chain shortages and rising costs of medicines and supplies fall especially on small hospitals, rural hospitals, and ASCs as they all run extremely tight margins. Recent shortages of IV fluids were deeply felt in these facilities and communities. We therefore stress that anesthesia drugs must be included on any lists of essential medicines.
While AANA wholly supports the domestic production and supply of PPE and medicines, anesthesia drugs required across the perioperative continuum require flexibilities for emergencies. In previous circumstances the Food and Drug Administration (FDA) has conducted emergency inspections of foreign facilities to
https://issuu.com/aanapublishing/docs/7-_ketamine_infusion_therapy_for_psychiatric_diso?fr=sNTFhMjU2NDAxMjU.
9
For more on this topic see AANA Comments on HHS Request for Information: Accelerating the Adoption and Use of Artificial Intelligence as Part of Clinical Care [RIN 0955-AA13], February 18, 2026, available at: https://www.aana.com/wp-content/uploads/2026/02/AANA-Comment-Letter-responding-to-the-Department-of-Health-Human-Services-Request-for-Information.pdf.
allow temporary importation of foreign drugs in critical shortages such as Propoven, the European version of Propofol. Additionally, payment structure must match clinical realities such as correct vial sizes of Propofol, which is single use but 100mL vials do not match every case, such as pediatric cases, and therefore creates unnecessary waste. We propose CMS continue to conduct stakeholder input events to gather more specialty specific information and strongly recommend utilizing CRNA expertise to ensure anesthesia care is fully incorporated in PPE and essential medicine supply chain planning.
7.
If finalized, CMS should modify the Advance Care Planning eCQM for the hospital outpatient setting and provide implementation guidance that reflects the roles of outpatient specialists and procedural providers.
AANA applauds CMS' efforts to advance person-centered care by exploring the inclusion of an Advance Care Planning (ACP) eCQM within the Hospital OQR Program. Advance care planning is an important component of high-quality care, particularly for patients with serious illness or those undergoing high-risk procedures. However, we encourage CMS to carefully consider how responsibility for this measure is attributed within the hospital outpatient setting. Advance care planning is typically initiated and maintained by primary care providers or attending physicians who have an ongoing longitudinal relationship with the patient. By contrast, hospital outpatient clinicians such as surgeons, certified registered nurse anesthetists, and other specialists often have limited encounters that are focused on a specific procedure or episode of care. If the measure is attributed to outpatient procedural providers or specialists, we believe the current measure specifications would require modification to reflect their role in the continuum of care.
Specifically, CMS should clarify whether the expectation is for outpatient providers to initiate new advance care planning discussions, verify the presence of existing documentation, update existing documents, or simply document that advance care planning was addressed. Without clearly defining provider responsibilities, implementation may create duplicative documentation requirements and administrative burden without meaningfully improving patient-centered care.
We also note that the proposed measure includes no exclusions and applies to all adults aged 18 years and older. While advance care planning is beneficial for all adults, implementation may present unique challenges among younger populations, particularly patients aged 18 to 35 years, where advance directives and related documentation are less common. We implore CMS to provide additional information on strategies that facilities could use to increase advance care planning engagement among younger adults and whether alternative implementation approaches or risk-adjusted benchmarks should be considered for this population.
We encourage CMS to work closely with stakeholders, including CRNAs, during measure development to ensure that any future outpatient ACP measure is feasible to implement, appropriately attributed, and designed to improve meaningful patient engagement rather than solely increasing documentation.
8.
If finalized, CMS should ensure phase-of-care stratification of the All-Cause Transfer/Admission measure improves attribution, incorporates appropriate safeguards, and avoids unintended consequences for anesthesia providers.
AANA supports CMS' efforts to improve the usefulness and interpretation of the All-Cause Transfer/Admission measure through potential phase-of-care stratification. Stratifying transfers into pre-procedure, intra-procedure, and post-procedure categories has the potential to provide a more accurate understanding of when and why transfers occur and improve attribution of quality outcomes across the ASC setting. A phase-of-care approach could help distinguish transfers identified during pre-procedure evaluation from those related to intraoperative or postoperative events. This distinction is particularly important for recognizing the role of CRNAs, in identifying high-risk patients and facilitating appropriate escalation of care before a procedure begins. Transfers resulting from anesthesia-led preoperative assessments may represent effective patient safety practices rather than adverse outcomes associated with anesthesia care.
However, CMS should ensure that any future stratification methodology includes appropriate definitions, risk adjustment, and safeguards to prevent unintended consequences. Without careful measure design, more granular reporting could lead to misattribution of transfers to anesthesia providers or anesthesia services, particularly for events driven by patient complexity, underlying medical conditions, or appropriate clinical decision-making.
Additionally, phase-specific transfer data may eventually be considered by payers, facilities, or policymakers in quality evaluations, value-based arrangements, or contracting decisions. CMS should ensure that such data are not used to compare anesthesia providers or anesthesia delivery models without accounting for important differences, including:
Patient acuity and complexity.
Case mix and procedure types.
Facility resources and capabilities.
Availability of emergency support and hospital resources.
Differences in populations served, including rural and underserved communities.
We also recommend that CMS carefully consider the data sources used to identify and attribute transfers. If claims-based methodologies are used, CMS should ensure accurate attribution through appropriate diagnosis codes, CPT codes, and modifiers, including those associated with anesthesia services, to avoid inaccurate assignment of outcomes to providers.
Finally, CMS should carefully define the time anchors used for stratification. We recommend using procedure start and stop times, rather than anesthesia start and stop times, as the primary reference point for categorizing transfers. While many ASC procedures involve anesthesia services, not all procedures require anesthesia. Some procedures may be performed under local anesthesia or with sedation administered by other qualified clinical staff. Using anesthesia start and stop times could exclude certain ASC procedures and limit the completeness and comparability of the measure. We further request that CMS clarify that procedure start and stop times are intended solely for measure calculation and should not be used as a basis for determining anesthesia coverage, payment, or reimbursement. This clarification is particularly important given that some insurers have attempted to impose arbitrary time limits on anesthesia coverage and payment based on procedure times, which may not accurately reflect the time or resources required to provide anesthesia services.
Overall, we agree that the All-Cause Transfer/Admission measure is an important quality and patient safety measure, and additional stratification may improve its clinical relevance. However, successful implementation will require clear definitions, appropriate risk adjustment, accurate attribution, and consideration of the diverse clinical settings and anesthesia delivery models represented within ASCs.
Thank you for your time and attention to the critical role of CRNAs in our nation's healthcare workforce and the Medicare program. Should you have any questions or need to request a meeting please contact Romy Gelb-Zimmer, Director of Regulatory Affairs, at rgelb-zimmer@aana.com or Emily Champlin, Associate Director of Regulatory Affairs at echamplin@aana.com.
Sincerely,
Jeffrey E. Molter CRNA, MSN, MBA
AANA President
CC: William Bruce, MBA, AANA Chief Executive Officer
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2344-0734
AAEC Urges CMS to Consider Vendor Certification and Small Practice Exceptions in RPM and RTM Policy
Carter Struck
WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
AAEC Comment on CMS-1848-P: CY 2027 Medicare Physician Fee Schedule Proposed Rule
Re: Remote Patient Monitoring and Remote Therapeutic Monitoring Provisions
Submitted via regulations.gov
Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1848-P P.O. Box 8016 Baltimore, MD 21244-8016
The American Association for Elder Care (AAEC) appreciates the opportunity to comment on the ... Show Full Article WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. AAEC Comment on CMS-1848-P: CY 2027 Medicare Physician Fee Schedule Proposed Rule Re: Remote Patient Monitoring and Remote Therapeutic Monitoring Provisions Submitted via regulations.gov Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1848-P P.O. Box 8016 Baltimore, MD 21244-8016 The American Association for Elder Care (AAEC) appreciates the opportunity to comment on theCalendar Year 2027 Medicare Physician Fee Schedule Proposed Rule (CMS-1848-P), specifically the proposed changes to Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM) services.
About AAEC
AAEC is a 501(c)(3) nonprofit organization dedicated to advancing standards and best practices in elder care. Our leadership includes experts serving on the U.S. Technical Advisory Group for ISO TC 314 (Ageing Societies) and the Partnership for Quality Measurement (PQM) Endorsement and Maintenance Committee for Advanced Illness and Post-Acute Care. We have contributed resources to the WHO Global Database of Age-Friendly Practices and developed Age-Friendly Community (AFC) certification standards aligned with the WHO 8 Domains of Livability.
Summary Position
AAEC supports CMS's goal of strengthening oversight and reducing inappropriate billing in RPM/RTM services. However, we are concerned that the proposed prohibition on third-party vendor services may produce unintended consequences that harm older adults' access to remote monitoring-particularly those served by small and mid-sized practices in community settings.
Concerns
1. Market Consolidation and Reduced Competition
The proposed rule would require RPM/RTM services to be furnished exclusively by clinical staff employed directly by the billing practice. While this addresses legitimate concerns about accountability, it creates significant operational barriers for small and mid-sized practices that lack the resources to hire dedicated monitoring staff.
We anticipate that many smaller practices-including independent primary care physicians, geriatricians, and community health centers serving older populations-will discontinue RPM/RTM services rather than absorb the fixed costs of in-house monitoring programs.
The likely result is market consolidation: large health systems and hospital-affiliated practices, which can spread monitoring costs across larger patient panels, will dominate RPM/RTM delivery. This consolidation risks:
Reduced competition and upward pressure on costs
Loss of localized, relationship-based care that smaller practices provide
Geographic disparities as rural and underserved areas lose RPM access
2. Impact on Aging Populations
Older adults disproportionately benefit from RPM services for chronic condition management, fall prevention, and early intervention. Many seniors prefer to receive care from familiar community providers rather than large institutional systems.
If small practices exit RPM, elderly patients face difficult choices: - Transfer to unfamiliar large health systems for monitoring services - Forgo RPM entirely, increasing risk of preventable hospitalizations - Travel longer distances for in-person visits that RPM could have replaced
This outcome conflicts with CMS's broader goals of supporting aging in place and reducing avoidable acute care utilization.
3. Quality vs. Employment Status
The proposed rule assumes that employment status determines service quality. We respectfully suggest that quality depends on clinical competence, oversight structures, and accountability mechanisms-not solely on whether staff are W-2 employees or contracted through qualified vendors.
Recommendations
AAEC urges CMS to consider alternative approaches that address fraud and quality concerns while preserving access:
1. Establish Vendor Certification Requirements
Rather than prohibiting third-party vendors, CMS could require vendors furnishing RPM/RTM services to meet certification standards, including: - Clinical staff credentialing and training requirements - Quality reporting obligations - Audit and compliance protocols - Contractual accountability to the billing practice
2. Strengthen Billing Practice Oversight Obligations
Require billing practices to maintain documented oversight of contracted RPM/RTM services, including regular quality reviews and patient outcome tracking.
3. Create a Small Practice Exception or Transition Period
If CMS proceeds with employment requirements, consider: - A transition period (e.g., 2-3 years) allowing practices to adjust operations - An exception for practices below a certain size threshold (e.g., fewer than 5 providers) - Technical assistance programs to help small practices develop in-house capacity
4. Monitor for Consolidation Effects
Include provisions for CMS to monitor market concentration in RPM/RTM services post-implementation and revisit the policy if access disparities emerge.
Conclusion
AAEC shares CMS's commitment to program integrity and high-quality remote monitoring services. We urge the Agency to balance these important goals against the risk of unintended market consolidation that could reduce options for older adults and undermine the community-based care model that many seniors depend on.
We welcome the opportunity to discuss these concerns further and to share insights from our work in age-friendly care standards.
Respectfully submitted,
American Association for Elder Care 200 W Sahara Ave Las Vegas, NV 89102 Phone: (510) 366-0281 Email: Info@aaeldercare.org
Comment submitted in response to CMS-1848-P, CY 2027 Medicare Physician Fee Schedule Proposed Rule. Comments due September 14, 2026.
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2377-5113
AAEC Comment on CMS-1848-P: CY 2027 Medicare Physician Fee Schedule Proposed Rule
Re: Remote Patient Monitoring and Remote Therapeutic Monitoring Provisions
Submitted via regulations.gov
Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1848-P P.O. Box 8016 Baltimore, MD 21244-8016
The American Association for Elder Care (AAEC) appreciates the opportunity to comment on the ... Show Full Article WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. AAEC Comment on CMS-1848-P: CY 2027 Medicare Physician Fee Schedule Proposed Rule Re: Remote Patient Monitoring and Remote Therapeutic Monitoring Provisions Submitted via regulations.gov Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1848-P P.O. Box 8016 Baltimore, MD 21244-8016 The American Association for Elder Care (AAEC) appreciates the opportunity to comment on theCalendar Year 2027 Medicare Physician Fee Schedule Proposed Rule (CMS-1848-P), specifically the proposed changes to Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM) services.
About AAEC
AAEC is a 501(c)(3) nonprofit organization dedicated to advancing standards and best practices in elder care. Our leadership includes experts serving on the U.S. Technical Advisory Group for ISO TC 314 (Ageing Societies) and the Partnership for Quality Measurement (PQM) Endorsement and Maintenance Committee for Advanced Illness and Post-Acute Care. We have contributed resources to the WHO Global Database of Age-Friendly Practices and developed Age-Friendly Community (AFC) certification standards aligned with the WHO 8 Domains of Livability.
Summary Position
AAEC supports CMS's goal of strengthening oversight and reducing inappropriate billing in RPM/RTM services. However, we are concerned that the proposed prohibition on third-party vendor services may produce unintended consequences that harm older adults' access to remote monitoring-particularly those served by small and mid-sized practices in community settings.
Concerns
1. Market Consolidation and Reduced Competition
The proposed rule would require RPM/RTM services to be furnished exclusively by clinical staff employed directly by the billing practice. While this addresses legitimate concerns about accountability, it creates significant operational barriers for small and mid-sized practices that lack the resources to hire dedicated monitoring staff.
We anticipate that many smaller practices-including independent primary care physicians, geriatricians, and community health centers serving older populations-will discontinue RPM/RTM services rather than absorb the fixed costs of in-house monitoring programs.
The likely result is market consolidation: large health systems and hospital-affiliated practices, which can spread monitoring costs across larger patient panels, will dominate RPM/RTM delivery. This consolidation risks:
Reduced competition and upward pressure on costs
Loss of localized, relationship-based care that smaller practices provide
Geographic disparities as rural and underserved areas lose RPM access
2. Impact on Aging Populations
Older adults disproportionately benefit from RPM services for chronic condition management, fall prevention, and early intervention. Many seniors prefer to receive care from familiar community providers rather than large institutional systems.
If small practices exit RPM, elderly patients face difficult choices: - Transfer to unfamiliar large health systems for monitoring services - Forgo RPM entirely, increasing risk of preventable hospitalizations - Travel longer distances for in-person visits that RPM could have replaced
This outcome conflicts with CMS's broader goals of supporting aging in place and reducing avoidable acute care utilization.
3. Quality vs. Employment Status
The proposed rule assumes that employment status determines service quality. We respectfully suggest that quality depends on clinical competence, oversight structures, and accountability mechanisms-not solely on whether staff are W-2 employees or contracted through qualified vendors.
Recommendations
AAEC urges CMS to consider alternative approaches that address fraud and quality concerns while preserving access:
1. Establish Vendor Certification Requirements
Rather than prohibiting third-party vendors, CMS could require vendors furnishing RPM/RTM services to meet certification standards, including: - Clinical staff credentialing and training requirements - Quality reporting obligations - Audit and compliance protocols - Contractual accountability to the billing practice
2. Strengthen Billing Practice Oversight Obligations
Require billing practices to maintain documented oversight of contracted RPM/RTM services, including regular quality reviews and patient outcome tracking.
3. Create a Small Practice Exception or Transition Period
If CMS proceeds with employment requirements, consider: - A transition period (e.g., 2-3 years) allowing practices to adjust operations - An exception for practices below a certain size threshold (e.g., fewer than 5 providers) - Technical assistance programs to help small practices develop in-house capacity
4. Monitor for Consolidation Effects
Include provisions for CMS to monitor market concentration in RPM/RTM services post-implementation and revisit the policy if access disparities emerge.
Conclusion
AAEC shares CMS's commitment to program integrity and high-quality remote monitoring services. We urge the Agency to balance these important goals against the risk of unintended market consolidation that could reduce options for older adults and undermine the community-based care model that many seniors depend on.
We welcome the opportunity to discuss these concerns further and to share insights from our work in age-friendly care standards.
Respectfully submitted,
American Association for Elder Care 200 W Sahara Ave Las Vegas, NV 89102 Phone: (510) 366-0281 Email: Info@aaeldercare.org
Comment submitted in response to CMS-1848-P, CY 2027 Medicare Physician Fee Schedule Proposed Rule. Comments due September 14, 2026.
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2377-5113
Allergy Specialist Urges CMS to Update Medicare Dose Definition and MUE Limits for Immunotherapy
Carter Struck
WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
Sebastian Lighvani, MD
Allergy Experts
Founder and Medical Director
1535 Second Avenue
New York, NY 10075
Telephone: 212-517-3300
Fax: 212-517-3303
August 16, 2026
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1848-P
P.O. Box 8016
Baltimore, MD 21244-8016
CMS Online submission link
Re: CMS-1848-P-CY 2027 Medicare Physician Fee Schedule Proposed Rule; CPT Code ... Show Full Article WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. Sebastian Lighvani, MD Allergy Experts Founder and Medical Director 1535 Second Avenue New York, NY 10075 Telephone: 212-517-3300 Fax: 212-517-3303 August 16, 2026 Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1848-P P.O. Box 8016 Baltimore, MD 21244-8016 CMS Online submission link Re: CMS-1848-P-CY 2027 Medicare Physician Fee Schedule Proposed Rule; CPT Code95165
Dear Administrator Oz:
I am a practicing allergist-immunologist writing in response to CMS's request for information concerning the definition of a "dose" for CPT code 95165, which describes the professional services associated with preparing allergenic extracts for allergen immunotherapy.
I am the Founder and Medical Director of Allergy Experts, a boutique allergy and immunology practice on the Upper East Side of Manhattan. Medicare beneficiaries make up approximately 20 percent of the patients receiving allergy immunotherapy in my practice, consistent with the broader shift CMS itself has recognized. Beyond the direct impact on Medicare claims, I am increasingly concerned that commercial insurers are following Medicare's lead and adopting the same 1 cc aliquot-based definition of a dose to justify reduced reimbursement. This trend does not reflect the actual clinical and administrative costs of running a modern immunotherapy practice, and if left unaddressed, an outdated Medicare definition will continue to be exported into the commercial market, compounding the financial strain on practices like mine that are trying to deliver individualized, clinically appropriate immunotherapy.
Background on Allergy Immunotherapy
Allergen immunotherapy is an important, disease-modifying treatment for patients with allergic rhinitis, allergic asthma, and other clinically significant allergic disease. Unlike treatments that address symptoms only while they are being taken, immunotherapy can alter the underlying allergic response and provide sustained clinical benefit. Effective immunotherapy can reduce symptoms, improve quality of life, decrease reliance on costly medications, and help prevent complications associated with poorly controlled allergic disease.
Adopt the CPT Definition of "Dose" for CPT Code 95165
I appreciate CMS's recognition that Medicare's current definition may not reflect contemporary clinical practice and may create confusion for physicians, patients, and payers. CMS currently treats a dose as a 1 cc aliquot, based on assumptions about vial preparation and use that dates back more than two decades. In the proposed rule, CMS acknowledges concerns held by myself and many of my colleagues that this approach may produce reimbursement-driven changes in medical practice rather than policies that reflect how immunotherapy is actually furnished.
The Medicare definition is inconsistent with CPT coding conventions and disconnected from how allergists practice. I strongly urge CMS to adopt the CPT definition and clinical understanding of a dose for CPT code 95165. CMS should specifically replace its existing definition of dose by defining dose as "a single injection from a multidose vial." This definition is consistent with other CPT codes for allergy immunotherapy (e.g., CPT codes 95115 and 95117). Under this approach, a dose will reflect the amount of allergenic extract prepared for administration to a patient as a single injection.
This position is consistent with that held by my professional specialty societies.(1)
Emphasizing the Importance of Adopting CPT's Definition of Dose for 95165
Allergy immunotherapy doses are individualized based on the patient's sensitivities, treatment phase, prescribed concentration, number of allergen mixtures, tolerance, and response to therapy. The volume administered changes throughout the build-up, maintenance, dose adjustments, missed treatments, illness, or periods of increased allergen exposure. Medicare's definition of dose does not accurately represent the number of clinically usable doses prepared for a patient.
CMS acknowledges that Medicare beneficiaries now account for a significant portion of the allergy immunotherapy population. In my practice, Medicare beneficiaries represent approximately 20 percent of patients receiving allergy immunotherapy. This is consistent with the specialty information cited by CMS indicating that Medicare beneficiaries may comprise more than 20 percent of an individual practice's immunotherapy patients, compared with fewer than 5 percent when the existing policy was developed.
As the Medicare population has grown, the consequences of maintaining an outdated and Medicare-specific definition have become substantially more significant.
Adopting the CPT definition would promote consistency, reduce billing confusion, and allow treatment decisions to be driven by patient needs rather than reimbursement rules. It would also reduce the likelihood that Medicare's unique interpretation will be adopted by Medicaid programs and commercial insurers, which compounds the harmful impact of this outdated policy. A uniform definition would make it easier for physicians to document services accurately, for contractors to adjudicate claims consistently, and for patients to receive treatment according to clinically appropriate protocols.
Eliminate or Raise the Medically Unlikely Edits (MUE) Cap
I also urge CMS to eliminate or significantly increase the medically unlikely edit limit for CPT code 95165. The current MUE of 30 units per claim is insufficient for many medically necessary treatment plans. Patients may require multiple separate allergen mixtures because certain extracts are incompatible and cannot safely or effectively be combined in the same vial. A patient receiving injections from two or three separately prepared vials can therefore require substantially more than 30 clinically appropriate doses during a preparation cycle. The current edit does not adequately account for multiple-vial treatment, individualized build-up schedules, or the number of doses that can be prepared from a multidose vial under the CPT definition.
CMS should replace the per-claim limit with a clinically appropriate annual framework or, at minimum, substantially raise the MUE so that it does not routinely interfere with legitimate care. CMS notes that specialty societies have recommended annual limits that recognize higher utilization during the first year of therapy, including up to 160 doses during the build-up year and 130 or fewer doses during subsequent maintenance years. An annual approach would be better aligned with the longitudinal nature of immunotherapy and would allow CMS to identify unusual utilization without denying or delaying routine, medically necessary treatment.
Any utilization safeguard should also permit exceptions based on documented medical necessity. Patients differ in the number of clinically incompatible allergen mixtures they require, the duration and frequency of build-up, their tolerance of dose increases, and the adjustments needed following treatment interruptions or adverse reactions. A rigid per-claim cap cannot appropriately account for these differences.
Conclusion
For these reasons, I respectfully request that CMS:
Replace Medicare's definition of dose for CPT code 95165 by adopting the CPT definition and clinical interpretation of a dose for CPT code 95165, based on each dose prepared for administration as a single injection rather than a fixed 1 cc aliquot.
Eliminate or significantly increase the 30-unit MUE.
Consider replacing the per-claim MUE with clinically appropriate annual utilization parameters that account for build-up and maintenance therapy.
Establish a clear medical-necessity exception process for patients whose individualized treatment requires additional doses or multiple allergen mixtures.
Thank you for seeking input from practicing physicians and for considering changes that would align Medicare policy with current clinical practice. Updating the definition of a dose and addressing the inadequate MUE would improve coding consistency, reduce unnecessary administrative burdens, and protect Medicare beneficiaries' access to safe and effective allergy immunotherapy.
Sincerely,
Sebastian Lighvani, MD
Founder and Medical Director
Allergy Experts
New York, NY
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2377-6550
Sebastian Lighvani, MD
Allergy Experts
Founder and Medical Director
1535 Second Avenue
New York, NY 10075
Telephone: 212-517-3300
Fax: 212-517-3303
August 16, 2026
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1848-P
P.O. Box 8016
Baltimore, MD 21244-8016
CMS Online submission link
Re: CMS-1848-P-CY 2027 Medicare Physician Fee Schedule Proposed Rule; CPT Code ... Show Full Article WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. Sebastian Lighvani, MD Allergy Experts Founder and Medical Director 1535 Second Avenue New York, NY 10075 Telephone: 212-517-3300 Fax: 212-517-3303 August 16, 2026 Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-1848-P P.O. Box 8016 Baltimore, MD 21244-8016 CMS Online submission link Re: CMS-1848-P-CY 2027 Medicare Physician Fee Schedule Proposed Rule; CPT Code95165
Dear Administrator Oz:
I am a practicing allergist-immunologist writing in response to CMS's request for information concerning the definition of a "dose" for CPT code 95165, which describes the professional services associated with preparing allergenic extracts for allergen immunotherapy.
I am the Founder and Medical Director of Allergy Experts, a boutique allergy and immunology practice on the Upper East Side of Manhattan. Medicare beneficiaries make up approximately 20 percent of the patients receiving allergy immunotherapy in my practice, consistent with the broader shift CMS itself has recognized. Beyond the direct impact on Medicare claims, I am increasingly concerned that commercial insurers are following Medicare's lead and adopting the same 1 cc aliquot-based definition of a dose to justify reduced reimbursement. This trend does not reflect the actual clinical and administrative costs of running a modern immunotherapy practice, and if left unaddressed, an outdated Medicare definition will continue to be exported into the commercial market, compounding the financial strain on practices like mine that are trying to deliver individualized, clinically appropriate immunotherapy.
Background on Allergy Immunotherapy
Allergen immunotherapy is an important, disease-modifying treatment for patients with allergic rhinitis, allergic asthma, and other clinically significant allergic disease. Unlike treatments that address symptoms only while they are being taken, immunotherapy can alter the underlying allergic response and provide sustained clinical benefit. Effective immunotherapy can reduce symptoms, improve quality of life, decrease reliance on costly medications, and help prevent complications associated with poorly controlled allergic disease.
Adopt the CPT Definition of "Dose" for CPT Code 95165
I appreciate CMS's recognition that Medicare's current definition may not reflect contemporary clinical practice and may create confusion for physicians, patients, and payers. CMS currently treats a dose as a 1 cc aliquot, based on assumptions about vial preparation and use that dates back more than two decades. In the proposed rule, CMS acknowledges concerns held by myself and many of my colleagues that this approach may produce reimbursement-driven changes in medical practice rather than policies that reflect how immunotherapy is actually furnished.
The Medicare definition is inconsistent with CPT coding conventions and disconnected from how allergists practice. I strongly urge CMS to adopt the CPT definition and clinical understanding of a dose for CPT code 95165. CMS should specifically replace its existing definition of dose by defining dose as "a single injection from a multidose vial." This definition is consistent with other CPT codes for allergy immunotherapy (e.g., CPT codes 95115 and 95117). Under this approach, a dose will reflect the amount of allergenic extract prepared for administration to a patient as a single injection.
This position is consistent with that held by my professional specialty societies.(1)
Emphasizing the Importance of Adopting CPT's Definition of Dose for 95165
Allergy immunotherapy doses are individualized based on the patient's sensitivities, treatment phase, prescribed concentration, number of allergen mixtures, tolerance, and response to therapy. The volume administered changes throughout the build-up, maintenance, dose adjustments, missed treatments, illness, or periods of increased allergen exposure. Medicare's definition of dose does not accurately represent the number of clinically usable doses prepared for a patient.
CMS acknowledges that Medicare beneficiaries now account for a significant portion of the allergy immunotherapy population. In my practice, Medicare beneficiaries represent approximately 20 percent of patients receiving allergy immunotherapy. This is consistent with the specialty information cited by CMS indicating that Medicare beneficiaries may comprise more than 20 percent of an individual practice's immunotherapy patients, compared with fewer than 5 percent when the existing policy was developed.
As the Medicare population has grown, the consequences of maintaining an outdated and Medicare-specific definition have become substantially more significant.
Adopting the CPT definition would promote consistency, reduce billing confusion, and allow treatment decisions to be driven by patient needs rather than reimbursement rules. It would also reduce the likelihood that Medicare's unique interpretation will be adopted by Medicaid programs and commercial insurers, which compounds the harmful impact of this outdated policy. A uniform definition would make it easier for physicians to document services accurately, for contractors to adjudicate claims consistently, and for patients to receive treatment according to clinically appropriate protocols.
Eliminate or Raise the Medically Unlikely Edits (MUE) Cap
I also urge CMS to eliminate or significantly increase the medically unlikely edit limit for CPT code 95165. The current MUE of 30 units per claim is insufficient for many medically necessary treatment plans. Patients may require multiple separate allergen mixtures because certain extracts are incompatible and cannot safely or effectively be combined in the same vial. A patient receiving injections from two or three separately prepared vials can therefore require substantially more than 30 clinically appropriate doses during a preparation cycle. The current edit does not adequately account for multiple-vial treatment, individualized build-up schedules, or the number of doses that can be prepared from a multidose vial under the CPT definition.
CMS should replace the per-claim limit with a clinically appropriate annual framework or, at minimum, substantially raise the MUE so that it does not routinely interfere with legitimate care. CMS notes that specialty societies have recommended annual limits that recognize higher utilization during the first year of therapy, including up to 160 doses during the build-up year and 130 or fewer doses during subsequent maintenance years. An annual approach would be better aligned with the longitudinal nature of immunotherapy and would allow CMS to identify unusual utilization without denying or delaying routine, medically necessary treatment.
Any utilization safeguard should also permit exceptions based on documented medical necessity. Patients differ in the number of clinically incompatible allergen mixtures they require, the duration and frequency of build-up, their tolerance of dose increases, and the adjustments needed following treatment interruptions or adverse reactions. A rigid per-claim cap cannot appropriately account for these differences.
Conclusion
For these reasons, I respectfully request that CMS:
Replace Medicare's definition of dose for CPT code 95165 by adopting the CPT definition and clinical interpretation of a dose for CPT code 95165, based on each dose prepared for administration as a single injection rather than a fixed 1 cc aliquot.
Eliminate or significantly increase the 30-unit MUE.
Consider replacing the per-claim MUE with clinically appropriate annual utilization parameters that account for build-up and maintenance therapy.
Establish a clear medical-necessity exception process for patients whose individualized treatment requires additional doses or multiple allergen mixtures.
Thank you for seeking input from practicing physicians and for considering changes that would align Medicare policy with current clinical practice. Updating the definition of a dose and addressing the inadequate MUE would improve coding consistency, reduce unnecessary administrative burdens, and protect Medicare beneficiaries' access to safe and effective allergy immunotherapy.
Sincerely,
Sebastian Lighvani, MD
Founder and Medical Director
Allergy Experts
New York, NY
*
Original text of letter here: https://www.regulations.gov/comment/CMS-2026-2377-6550
AIAA Praises FAA Certification Modernization Efforts to Enhance Safety and International Harmonization
Carter Struck
WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
July 2, 2026
U.S. Department of Transportation
1200 New Jersey Avenue SE,
West Building, 5th Floor (W58-213)
Washington, DC 20590-0001
To Whom It May Concern:
The American Institute of Aeronautics and Astronautics (AIAA) appreciates the opportunity to provide comments on the Federal Aviation Administration's Notice of Proposed Rulemaking, Transport Airplane and Propulsion Certification Modernization (Docket No.: ... Show Full Article WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. July 2, 2026 U.S. Department of Transportation 1200 New Jersey Avenue SE, West Building, 5th Floor (W58-213) Washington, DC 20590-0001 To Whom It May Concern: The American Institute of Aeronautics and Astronautics (AIAA) appreciates the opportunity to provide comments on the Federal Aviation Administration's Notice of Proposed Rulemaking, Transport Airplane and Propulsion Certification Modernization (Docket No.:FAA-2026-0430; Notice No. 26-09).
AIAA, which is the world's largest technical society dedicated to the global aerospace profession, represents a broad cross-section of the aerospace community, including engineers, researchers, certification specialists, manufacturers, operators, academia, and former government officials. Our members have spent decades navigating the certification process from every angle. Many have developed certification plans, negotiated special conditions, supported equivalent level of safety findings, participated in FAA and international working groups, and helped bring new aircraft and propulsion technologies from concept to certification. That experience shapes our perspective.
Overall, AIAA supports the FAA's effort to modernize 14 CFR Part 25 certification requirements. The proposal recognizes something the aerospace community has understood for years: the regulations themselves are often not the primary obstacle to innovation and advanced technology integration. The challenge is the growing reliance on exemptions, special conditions, and project-specific findings to accommodate the certification of technologies that have become increasingly common. The mechanisms that are in place have served aviation well by preserving safety while allowing innovation to proceed, but they were never intended to become the routine pathway for certification.
Reducing unnecessary reliance on project-specific certification mechanisms, such as exemptions, special conditions, and equivalent level of safety findings, has practical value beyond administrative efficiency. Every exemption or equivalent level of safety finding requires engineering resources from both applicants and the FAA. Those efforts often involve questions that have already been answered repeatedly on previous certification programs. When those answers become sufficiently mature, incorporating them directly into the regulations provides greater predictability for applicants while allowing FAA technical experts to focus their attention on genuinely novel technologies and emerging risks rather than revisiting well-established issues.
AIAA also supports the FAA's continued effort to harmonize certification standards with those of the European Union Aviation Safety Agency (EASA) where doing so does not compromise safety. Aerospace development has become inherently global. Manufacturers, suppliers, and certification authorities routinely operate across international markets, and unnecessary regulatory divergence increases both cost and schedule without producing corresponding safety benefits. Harmonization is most valuable when it preserves technical rigor while reducing duplicative work and conflicting requirements. The longstanding cooperation between the FAA and EASA demonstrates that this objective is both practical and achievable.
At the same time, regulatory modernization should not be viewed simply as an opportunity to accelerate certification timelines. Certification exists to establish confidence that increasingly complex aircraft and propulsion systems can safely operate throughout their intended service lives. As aircraft architectures evolve to incorporate advanced automation, new propulsion concepts, digital engineering tools, and increasingly integrated software, maintaining technical rigor becomes more important rather than less. Regulatory modernization succeeds when it removes unnecessary administrative burden while preserving the engineering and safety rigor that has made the U.S. certification system the global benchmark.
AIAA also encourages the FAA to continue engaging technical experts from industry, academia, standards development organizations, and international partners as implementation proceeds. Modern certification increasingly depends upon consensus technical standards, validated engineering methods, and shared operational experience. Maintaining that collaborative process will help ensure that future regulations remain both technically current and operationally practical.
Finally, successful implementation will depend not only on updated regulations but also on consistent guidance and application across certification programs. Applicants benefit when regulatory expectations are transparent, technically grounded, and consistently applied. Likewise, FAA engineers benefit from modern guidance that reflects current technologies and accepted engineering practice. Continued investment in workforce expertise, technical guidance, and collaboration will be essential to realizing the full benefits of this rulemaking.
AIAA appreciates the FAA's thoughtful approach to this modernization effort. We believe the proposal represents an important opportunity to improve certification efficiency, strengthen regulatory clarity, support international harmonization where appropriate, and position the certification framework to accommodate future aerospace technologies while maintaining the high level of safety that defines U.S. aviation.
Thank you for considering these comments.
Respectfully submitted,
Clay Mowry
CEO, AIAA
*
Original text of letter here: https://www.regulations.gov/comment/FAA-2026-0430-0010
July 2, 2026
U.S. Department of Transportation
1200 New Jersey Avenue SE,
West Building, 5th Floor (W58-213)
Washington, DC 20590-0001
To Whom It May Concern:
The American Institute of Aeronautics and Astronautics (AIAA) appreciates the opportunity to provide comments on the Federal Aviation Administration's Notice of Proposed Rulemaking, Transport Airplane and Propulsion Certification Modernization (Docket No.: ... Show Full Article WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. July 2, 2026 U.S. Department of Transportation 1200 New Jersey Avenue SE, West Building, 5th Floor (W58-213) Washington, DC 20590-0001 To Whom It May Concern: The American Institute of Aeronautics and Astronautics (AIAA) appreciates the opportunity to provide comments on the Federal Aviation Administration's Notice of Proposed Rulemaking, Transport Airplane and Propulsion Certification Modernization (Docket No.:FAA-2026-0430; Notice No. 26-09).
AIAA, which is the world's largest technical society dedicated to the global aerospace profession, represents a broad cross-section of the aerospace community, including engineers, researchers, certification specialists, manufacturers, operators, academia, and former government officials. Our members have spent decades navigating the certification process from every angle. Many have developed certification plans, negotiated special conditions, supported equivalent level of safety findings, participated in FAA and international working groups, and helped bring new aircraft and propulsion technologies from concept to certification. That experience shapes our perspective.
Overall, AIAA supports the FAA's effort to modernize 14 CFR Part 25 certification requirements. The proposal recognizes something the aerospace community has understood for years: the regulations themselves are often not the primary obstacle to innovation and advanced technology integration. The challenge is the growing reliance on exemptions, special conditions, and project-specific findings to accommodate the certification of technologies that have become increasingly common. The mechanisms that are in place have served aviation well by preserving safety while allowing innovation to proceed, but they were never intended to become the routine pathway for certification.
Reducing unnecessary reliance on project-specific certification mechanisms, such as exemptions, special conditions, and equivalent level of safety findings, has practical value beyond administrative efficiency. Every exemption or equivalent level of safety finding requires engineering resources from both applicants and the FAA. Those efforts often involve questions that have already been answered repeatedly on previous certification programs. When those answers become sufficiently mature, incorporating them directly into the regulations provides greater predictability for applicants while allowing FAA technical experts to focus their attention on genuinely novel technologies and emerging risks rather than revisiting well-established issues.
AIAA also supports the FAA's continued effort to harmonize certification standards with those of the European Union Aviation Safety Agency (EASA) where doing so does not compromise safety. Aerospace development has become inherently global. Manufacturers, suppliers, and certification authorities routinely operate across international markets, and unnecessary regulatory divergence increases both cost and schedule without producing corresponding safety benefits. Harmonization is most valuable when it preserves technical rigor while reducing duplicative work and conflicting requirements. The longstanding cooperation between the FAA and EASA demonstrates that this objective is both practical and achievable.
At the same time, regulatory modernization should not be viewed simply as an opportunity to accelerate certification timelines. Certification exists to establish confidence that increasingly complex aircraft and propulsion systems can safely operate throughout their intended service lives. As aircraft architectures evolve to incorporate advanced automation, new propulsion concepts, digital engineering tools, and increasingly integrated software, maintaining technical rigor becomes more important rather than less. Regulatory modernization succeeds when it removes unnecessary administrative burden while preserving the engineering and safety rigor that has made the U.S. certification system the global benchmark.
AIAA also encourages the FAA to continue engaging technical experts from industry, academia, standards development organizations, and international partners as implementation proceeds. Modern certification increasingly depends upon consensus technical standards, validated engineering methods, and shared operational experience. Maintaining that collaborative process will help ensure that future regulations remain both technically current and operationally practical.
Finally, successful implementation will depend not only on updated regulations but also on consistent guidance and application across certification programs. Applicants benefit when regulatory expectations are transparent, technically grounded, and consistently applied. Likewise, FAA engineers benefit from modern guidance that reflects current technologies and accepted engineering practice. Continued investment in workforce expertise, technical guidance, and collaboration will be essential to realizing the full benefits of this rulemaking.
AIAA appreciates the FAA's thoughtful approach to this modernization effort. We believe the proposal represents an important opportunity to improve certification efficiency, strengthen regulatory clarity, support international harmonization where appropriate, and position the certification framework to accommodate future aerospace technologies while maintaining the high level of safety that defines U.S. aviation.
Thank you for considering these comments.
Respectfully submitted,
Clay Mowry
CEO, AIAA
*
Original text of letter here: https://www.regulations.gov/comment/FAA-2026-0430-0010
Adeia Urges Public Disclosure of All Parties Behind Ex Parte Reexamination Requests
Carter Struck
WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
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August 20, 2026
Via Federal eRulemaking Portal (https://www.regulations.gov)
U.S. Department of Commerce
U.S. Patent and Trademark Office
37 CFR Part 1
Docket No. PTO-P-2025-0545
RIN 0651-AD94
Re:
Comments by Adeia Inc. in Support of the Proposed "Requirement to Identify All Real Parties in Interest to a Third Party Request for an Ex Parte ... Show Full Article WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. adeia.com | +1 408-473-2500 | 3025 Orchard Parkway San Jose, CA 95134 1 of 8 August 20, 2026 Via Federal eRulemaking Portal (https://www.regulations.gov) U.S. Department of Commerce U.S. Patent and Trademark Office 37 CFR Part 1 Docket No. PTO-P-2025-0545 RIN 0651-AD94 Re: Comments by Adeia Inc. in Support of the Proposed "Requirement to Identify All Real Parties in Interest to a Third Party Request for an Ex ParteReexamination" (Docket No. PTO-P-2025-0545)
Adeia Inc. ("Adeia") submits these comments in response to the U.S. Patent and Trademark Office ("USPTO" or "Office") Notice of Proposed "Requirement to Identify All Real Parties in Interest to a Third Party Request for an Ex Parte Reexamination" [Docket No. PTO-P-2025-0545] RIN 0651-AD94, 91 Fed. Reg. 46,038-42 (July 22, 2026) ("Proposed Rule").
I.
BACKGROUND
Adeia is a publicly traded, U.S.-based research and development ("R&D") technology company headquartered in Silicon Valley (NASDAQ: ADEA). Adeia invents, develops, and accelerates the adoption of next-generation technologies for the semiconductor and media industries. Adeia is among the most innovative companies in America, ranking in the Top 30 U.S. companies granted the most U.S. patents last year. In 2025, Adeia invested $67 million into R&D, representing more than 15% of its annual revenue. Adeia's advanced semiconductor R&D includes hybrid bonding and thermal management technologies critical to the development of artificial intelligence ("AI") and data center infrastructure. Adeia's media technologies include leading-
See Intellectual Property Owners Ass'n & Harrity Analytics, Top 300 Organizations Granted U.S. Patents in 2025, 43rd Annual Listing (June 15, 2026), available at https://ipo.org/wp-content/uploads/2026/06/2026-IPO-Top-Patent-Owners-List.pdf (ranking Adeia #66 among all organizations worldwide, and among the top 30 U.S.-headquartered companies, to be granted the most U.S. patents in 2025). Adeia was granted more patents last year than HP, AMD, Meta, Broadcom, and many other technology leaders. See, e.g., Yole Group, Hybrid Bonding & Latest Advancements in 2.5D/3D Packaging Industry (Feb. 27, 2025), available at https://www.yolegroup.com/player-interviews/hybrid-bonding-latest-advancements-2-5d-3d-packaging-industry-an-interview-with-adeia/ ("ADEIA is the market leader in providing innovations for hybrid bonding. At the heart of AI, data center, and HPC [high-performance computing], is massively parallel processing of bits, which requires scaling the interconnect to finer pitches for high bandwidth, low power interfaces. Hybrid bonding is the core technology to make this interconnect a reality."); 3DInCites, An Integrated Cooling Solution for Hot Chips (June 4, 2025), available at https://www.3dincites.com/2025/06/an-integrated-cooling-solution-for-hot-chips/ ("Adeia's Integrated Cooling Solution represents a paradigm shift in semiconductor thermal management. By eliminating the TIM layer and leveraging advanced silicon bonding techniques, ICS delivers improved thermal efficiency-reducing chip temperatures, increasing reliability-to enabling higher computational chipsets for AI-centric data centers."); see also Storagenewsletter.com, FMS 2025: Best of Show Award Winners 2025 (Aug. 7, 2025) (Adeia's hybrid bonding technology awarded "Most Innovative Technology" in the 3D Memory Technology edge advancements in video streaming, as well as pioneering AI solutions that enable media and entertainment platforms to deliver more immersive experiences. Adeia holds over 14,000 U.S. and foreign patents and patent applications, and is a major stakeholder in the U.S. patent system.
Adeia applauds USPTO leadership for recognizing the need for the Proposed Rule. Adeia supports the Proposed Rule, with one recommended change noted in Part II.B below.
II.
ADEIA COMMENTS
A.
Adeia Has Experienced a Surge of Anonymous EPR Requests.
The Proposed Rule's observation that "[t]he Office is currently receiving a significant number of ex parte reexamination ['EPR'] requests" is consistent with Adeia's experience. Adeia is not aware of having received a single EPR request against any of its patents for more than a decade prior to October 2025. But in the six months that followed, Adeia received notice of 10 EPR requests-all filed anonymously:
Patent # Application # EPR Filing Date Law Firm Filing EPR Real Party in Interest
9,690,833 90/015,568 Oct. 1, 2025 Holzer Patel Drennan Anonymous
7,890,490 90/015,595 Oct. 10, 2025 Holzer Patel Drennan Anonymous
8,949,231 90/015,617 Oct. 22, 2025 Holzer Patel Drennan Anonymous
8,516,524 90/015,815 Dec. 22, 2025 Holzer Patel Drennan Anonymous
8,825,576 90/015,823 Dec. 23, 2025 Holzer Patel Drennan Anonymous
10,965,726 90/015,822 Dec. 23, 2025 Holzer Patel Drennan Anonymous
8,375,069 90/015,868 Jan. 8, 2026 Holzer Patel Drennan Anonymous
9,355,182 90/015,896 Jan. 20, 2026 Holzer Patel Drennan Anonymous
10,931,992 90/015,979 Feb. 19, 2026 Holzer Patel Drennan Anonymous
9,223,873 90/016,116 Apr. 1, 2026 Holzer Patel Drennan Anonymous
In each instance in which reexamination was ordered, Adeia was forced to defend its duly issued patent without knowing whether the requester is a current or prospective licensee, a competitor, an affiliate of a previously estopped party, a party acting at the direction of another entity, or a foreign-backed entity.
category), available at https://www.storagenewsletter.com/2025/08/07/fms-2025-best-of-show-award-winners-2025/. See Business Intelligence Group, AI Breakthroughs of 2025 - Celebrating the Visionaries, Innovators & Trailblazers of the Artificial Intelligence Excellence Awards (Mar. 25, 2025), available at https://www.bintelligence.com/posts/ai-breakthroughs-of-2025-celebrating-the-visionaries-innovators-and-trailblazers-of-the-artificial-intelligence-excellence-awards (recognizing Adeia for its "remarkable contributions to the AI industry"). Proposed Rule, 91 Fed. Reg. 46,039. See also RPX, Reexams Surge Again in Q1-Prompting USPTO to Take Limiting Measures (May 27, 2026) ("The first quarter saw a particularly large spike in filings, going up by 190% compared to Q1 2025."), available at https://www.rpxcorp.com/data-byte/reexams-surge-again-in-q1-prompting-uspto-to-take-limiting-measures/.
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Adeia agrees with the Proposed Rule's goals of allowing the Office to assess whether an estoppel applies and to identify mistakes or misrepresentations in the certification. But disclosure to the Office alone would solve only part of the problem. As the Proposed Rule recognizes, real party in interest ("RPI") status may be disputed and is highly fact-dependent. A patent owner may have relationship, licensing, litigation, or public-record evidence bearing on whether the requester's disclosure is complete and accurate. The final rule should also permit the patent owner, and to the fullest extent consistent with law, the public, to learn the RPI's identity and bring relevant evidence to the Office's attention.
B.
Adeia Recommendation: The RPI's Identity Should Also Be Disclosed to the Public, or at Minimum, to the Patent Owner.
The Proposed Rule would permit disclosure of the RPI only to the Office, and suggests it is legally required or desirable from a policy standpoint to keep the RPI's identity secret from the public and patent owner. Adeia urges the Office to consider this further.
Adeia believes that greater RPI transparency is both legally permissible and better policy. As discussed further below, the statutory text does not expressly require secrecy for EPR RPIs; the original rationale for keeping the RPI's identity secret has been refuted by well over a decade of empirical evidence; and the Office has recognized the benefits of greater RPI transparency in other contexts.
Adeia's specific recommendation is that in proposed Sec. 1.510(b)(7), the final rule not include the sentence, "Upon the written request of the third party requester, the statement will be excluded from the patent and reexamination files and kept confidential":
Sec. 1.510 Request for ex parte reexamination.
* * * * *
(b) * * *
(7) A separate statement by the third party requester identifying all real parties in interest to the ex parte reexamination request. The statement must be submitted according to the parameters established by the Office. Upon the written request of the third party requester, the statement will be excluded from the patent and reexamination files and kept confidential.
Alternatively, Adeia recommends that the Office make clear that the phrase "kept confidential" permits disclosure not only to the Office, but also to the patent owner, on a confidential basis.
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1.
Sections 301(e) and 302 Do Not Require Confidentiality for EPR RPIs or Prevent Disclosure to the Patent Owner.
The only statute the Proposed Rule cites as requiring public anonymity of the RPI is 35 U.S.C. Sec. 301(e). Section 301 governs third party submissions citing prior art and prior written admissions of the patent owner that the third party wishes to be included in the patent file. It provides: "Upon the written request of the person citing prior art or written statements pursuant to subsection (a), that person's identity shall be excluded from the patent file and kept confidential."
But the Proposed Rule and the statute distinguish such "mere citations of prior art and written statements" under Section 301 from EPR requests, which are governed by Section 302. Section 301 does not refer to Section 302 or state that the identity of an EPR requester proceeding under Section 302 must be kept confidential. To the contrary, the plain text of Section 301 only requires that the identity of someone who files a written submission "pursuant to subsection (a) [of Section 301]" be kept confidential. 35 U.S.C. Sec. 301(e).
Nor does Section 302 itself include any provision requiring confidentiality of an RPI's identity. Section 302 provides that any third party can make an EPR request based on prior art cited under Section 301, but does not state that the confidentiality provisions of Section 301 would govern such a request. It simply says that an EPR requester can cite the prior art that was previously identified in a Section 301 submission. As such, mere citations of prior art and written statements submitted under Section 301 can remain anonymous, but when a third party takes the additional step of requesting reexamination under Section 302, the statutory text does not require that the requester's identity remain confidential. Not only that, Section 302 suggests the opposite, stating "[u]nless the requesting person is the owner of the patent, the Director promptly will send a copy of the request to the owner of record of the patent." 35 U.S.C. Sec. 302. This requirement to send the EPR request to the patent owner does not include any carve-out for the RPI's identity, such as a mandate that the identity be kept confidential or be redacted.
The Proposed Rule further cites Section 301's implementing regulation at 37 CFR Sec. 1.501(d), which provides that, "[i]f the person making the submission wishes his or her identity to be excluded from the patent file and kept confidential, the submission papers must be submitted anonymously without any identification of the person making the submission." But again, this only applies to submissions under Section 301. And the Proposed Rule would make it clear that Section 1.501(d) is limited to such "mere citations of prior art and written statements" under Section 301, and would not apply to EPR requests. The implementing regulations for EPRs are Sections 1.525-1.565, and none of those sections addresses the confidentiality of the requester's identity.
See Proposed Rule, 91 Fed. Reg. 46,040 ("Proposed Sec. 1.501(d) would be revised to clarify that papers submitted 'under this section' (i.e., mere citations of prior art and written statements) can be submitted anonymously without any identification of the person making the submission. The language 'under this section' would be added to distinguish citations of prior art and written statements submitted under Sec. 1.501, which may still be submitted anonymously, from ex parte reexamination requests under Sec. 1.510, which would now require identification of all real parties in interest to the request.").
Ibid.
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If the Office nonetheless concludes that 35 U.S.C. Sec. 301(e) applies to Section 302 and requires an EPR requester's identity to remain outside the public patent file, Adeia alternatively recommends that the final rule at least permit disclosure of the RPI's identity to the patent owner under reasonable confidentiality and use safeguards, and establish a procedure for the patent owner to submit evidence concerning the statement's completeness and any applicable estoppel. This is legally permitted under the same rationale as the Proposed Rule's rationale for disclosing the RPI to the Office. The Proposed Rule states that Section 301(e) "only requires keeping the requester's identity confidential from the public, not from the Office." But Section 301(e) does not actually refer to "the public." It states that the requester's identity "shall be excluded from the patent file and kept confidential." 35 U.S.C. Sec. 301(e). Accordingly, if this language is interpreted to permit disclosure to the Office, the same interpretation would permit disclosure to the patent owner: the RPI's identity could still be excluded from the patent file, but disclosed to the patent owner confidentially.
2.
The Original Rationale for Maintaining RPI Anonymity Has Proven to Be Unfounded.
The Proposed Rule cites legislative history from nearly 50 years ago and public comments from 2012 as evidence of the asserted need to keep an RPI's identity secret from the public. But the original hypothetical worry-that disclosing an RPI's identity would supposedly chill a third party's willingness to file an EPR-has been substantially undermined by nearly fourteen years of experience under the AIA. One only has to look at inter partes reviews ("IPRs") to see that public RPI disclosure has not prevented widespread use by third-party patent challengers. Unlike EPR requesters, an IPR petitioner must disclose all RPIs. Despite that requirement, IPRs rapidly became, and for more than a decade remained, "the most-used type of post-grant proceeding introduced by the AIA by an overwhelming margin" and "the dominant mechanism for challenging issued U.S. patent claims." That would simply not be the case if disclosing the filer's identity had a chilling effect. The sustained level of use is powerful evidence that RPI disclosure does not materially deter legitimate patent challenges.
Id., 91 Fed. Reg. 46,039.
See ibid. (citing 1980 legislative history at H.R. Rep. 96-1307, 6, 1980 U.S.C.C.A.N. 6460, 6465; and citing Comments 20 and 25 to the August 2012 Final Rule, 77 Fed. Reg. at 46621).
Congressional Research Service, R48016, The Patent Trial and Appeal Board and Inter Partes Review, at 11 (2024), available at https://www.congress.gov/crs-product/R48016.
Patently-O, Decimation: Ex Parte Reexamination Eclipses the IPR (May 2, 2026), available at https://patentlyo.com/patent/2026/05/decimation-ex-parte-reexamination-eclipses-the-ipr.html. In IPRs' first five years of operation, filings more than tripled, surging from 514 petitions in the first full fiscal year (FY2013) to 1,812 petitions in FY2017. This elevated level of filings stayed relatively consistent over the following years, with 1,361 IPR petitions filed in FY2025, more than 21/2 times the FY2013 level. See U.S. Patent & Trademark Office, PTAB Trial Statistics: FY25 End of Year Outcome Roundup, at 3 (2025), available at https://www.uspto.gov/sites/default/files/documents/Trial_StatsFY25_Q4.pdf; U.S. Patent & Trademark Office, Trial Statistics: IPR, PGR, CBM, at 5 (Sept. 2017), available at https://www.uspto.gov/sites/default/files/documents/Trial_Stats_2017-09-30.pdf; U.S. Patent & Trademark Office, Patent Trial and Appeal Board Statistics, at 4 (Sept. 30, 2015), available at https://www.uspto.gov/sites/default/files/documents/2015-09-30%20PTAB.pdf.
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3.
Public Policy Favors Disclosing an RPI's Identity to the Patent Owner and Public.
There are many strong public policy reasons for greater RPI transparency, which the Office has recognized in other contexts.
a.
Efficient resolution of licensing and other disputes.
If the patent owner knew the RPIs behind EPRs, it could facilitate the efficient resolution of licensing discussions or other disputes. The Office's Consolidated Trial Practice Guide explains that, at a general level, the RPI in an AIA proceeding is "the party that desires review of the patent," which may include "the party or parties at whose behest the petition has been filed." Identifying the parties who actually desire review of a patent can enable the patent owner to engage directly with the entities having underlying commercial interests in the dispute, including through licensing discussions or other consensual resolution. Early resolution of disputes could avoid additional EPRs or other legal proceedings being filed, conserving resources of the parties, the Office, and potentially courts or other administrative agencies.
This same efficiency rationale has been recognized in the related debate over transparency concerning third-party litigation funding. In a March 2026 submission to the federal Advisory Committee on Civil Rules proposing mandatory disclosure of third-party litigation funding, the U.S. Chamber of Commerce and Lawyers for Civil Justice explained that disclosure enables courts and parties to understand who they are actually negotiating with and who has settlement authority. They identified among the consequences of nondisclosure courts' inability to manage settlement conferences effectively, parties wasting time negotiating with nominal parties who lack authority, litigation continuing at the behest of hidden funders despite the parties' desire to settle, and surreptitious violations of confidentiality orders. The Advisory Committee itself identified "whether a funder should be involved in settlement conferences" and "whether a funder has influence or even a veto power over settlement" as potential purposes of third-party litigation funding transparency.
b.
Adjudicative integrity.
RPI disclosure to patent owners can also improve the Office's ability to identify duplicative proceedings, statutory or collateral estoppel, and other issues implicated by the filing. Recent Director Review decisions demonstrate the important role that patent owners can play in that inquiry. In Yangtze Memory Technologies Co. v. Micron Technology, Inc., the Director vacated institution after the patent owner presented evidence sufficient to place the petitioner's RPI identification in dispute and the petitioner failed to rebut that evidence. Similarly, in the precedential Tianma Microelectronics Co. v. LG Display Co. decision, evidence presented by the patent owner placed in dispute both whether all RPIs had been identified and whether an RPI was a foreign government. In both cases, evidence presented by the patent owner assisted the Office in determining whether the petitioner had satisfied the RPI requirement.
Patent owners are particularly well positioned to provide such information because they know the parties with whom they are engaged in licensing discussions and other patent disputes. For example, a patent owner may know facts indicating that a requester is affiliated with an estopped party; that an RPI disclosure is incomplete or inaccurate; that the request is being funded or directed by another entity; or that confidential information from licensing discussions has been used in preparing the reexamination request. Keeping the disclosed RPIs secret from the patent owner deprives the Office of precisely the type of information that its recent RPI decisions demonstrate patent owners can provide.
c.
National security.
In a memorandum to all PTAB judges dated October 28, 2025, Director Squires reinstated the strict requirement that IPR petitioners identify all RPIs behind their petitions before institution, designating as precedential Corning Optical Communications RF, LLC v. PPC Broadband Inc., IPR2014-00440, Paper 68 (PTAB Aug. 18, 2015). The Director noted that inadequate RPI disclosure presents significant national-security concerns because opaque investment structures can permit foreign adversaries and state-linked entities to finance or direct U.S. patent challenges, including in strategically important technologies such as semiconductors and AI. He concluded that "the RPI requirement functions not merely as a procedural safeguard, but as a national-security measure," and that "[t]he integrity of PTAB proceedings depends on knowing who is behind a petition-who funds it, directs it, and/or benefits from it."
Yangtze Memory Technologies Co., Ltd. v. Micron Technology, Inc., IPR2025-00098, IPR2025-00099, Paper 38 (PTAB Jan. 15, 2026) (Director Review Order vacating decisions granting and denying institution), available at https://www.uspto.gov/sites/default/files/documents/ipr2025-00098_paper38.pdf. Tianma Microelectronics Co., Ltd. v. LG Display Co., Ltd., IPR2025-01579, Paper 12 (PTAB Mar. 18, 2026) (precedential), available at https://www.uspto.gov/sites/default/files/documents/IPR2025-01579Paper12.pdf.
See Oct. 28, 2025 Memorandum from John A. Squires to All PTAB Judges, "Precedential Designation of Corning Optical Communications RF, LLC v. PPC Broadband Inc., IPR2014-00440, Paper 68 (PTAB Aug. 18, 2015)" (except for Sec. II.E.1), available at https://www.uspto.gov/sites/default/files/documents/Precedential_designation_of_Corning_Optical_Communications_RF_LLC_v._PPC_Broadband_Inc_Memo_-_Dated_10_28_25.pdf.
Id. at 2.
Id. at 4.
The same national-security considerations apply to RPI transparency in EPR proceedings. U.S. patent owners should not be required to defend their patents through an administrative proceeding while being denied knowledge of whether the entity behind that proceeding is affiliated with, controlled by, or acting on behalf of a foreign government or other foreign interest. The Director observed in his Memorandum that "parties on the Department of Commerce 'entity list,' i.e., parties 'involved in activities that are contrary to the national security or foreign policy interests of the United States'-have filed a substantial and increasing number of IPRs." Because EPR requesters currently may remain anonymous, neither the Office nor patent owners can determine whether these same actors are also using EPRs to challenge U.S. patents-a problem exacerbated by the recent EPR surge. Indeed, of the 10 EPRs that have been filed anonymously against Adeia patents in the past several months, neither Adeia nor the Office knows whether the filings were made at the behest of a foreign state or an entity backed by a foreign state.
d.
Public confidence in the U.S. patent system.
Greater RPI transparency also promotes public confidence in the U.S. patent system. As Director Squires observed, opacity concerning who funds, directs, or benefits from patent challenges can "undermine public confidence in the integrity of the patent system." That concern is not limited to IPRs. EPRs can result in cancellation or amendment of issued patent rights, and the public has a legitimate interest in knowing the parties whose interests are driving those proceedings. Public RPI disclosure would provide accountability for the use of an important governmental process, while placing EPRs on a more consistent footing with IPRs, where RPI identities are publicly disclosed. There is no apparent policy reason why transparency concerning the identity of the parties behind a patent challenge should depend on which Office proceeding they select.
III.
CONCLUSION
Adeia commends the Office on its leadership in developing the Proposed Rule. Adeia supports the Proposed Rule, but urges the Office also to require public disclosure of the identity of every RPI behind a third-party EPR request. At minimum, the final rule should require disclosure to the patent owner under appropriate confidentiality safeguards and provide a meaningful procedure for the patent owner to submit evidence concerning RPI completeness and estoppel.
Respectfully submitted,
ADEIA INC.
Michael C. Spillner
Head of Government Affairs and Public Policy
michael.spillner@adeia.com
Id. at 2-3.
Id. at 4.
*
Original text of letter here: https://www.regulations.gov/comment/PTO-P-2025-0545-0014
adeia.com | +1 408-473-2500 | 3025 Orchard Parkway San Jose, CA 95134
1 of 8
August 20, 2026
Via Federal eRulemaking Portal (https://www.regulations.gov)
U.S. Department of Commerce
U.S. Patent and Trademark Office
37 CFR Part 1
Docket No. PTO-P-2025-0545
RIN 0651-AD94
Re:
Comments by Adeia Inc. in Support of the Proposed "Requirement to Identify All Real Parties in Interest to a Third Party Request for an Ex Parte ... Show Full Article WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. adeia.com | +1 408-473-2500 | 3025 Orchard Parkway San Jose, CA 95134 1 of 8 August 20, 2026 Via Federal eRulemaking Portal (https://www.regulations.gov) U.S. Department of Commerce U.S. Patent and Trademark Office 37 CFR Part 1 Docket No. PTO-P-2025-0545 RIN 0651-AD94 Re: Comments by Adeia Inc. in Support of the Proposed "Requirement to Identify All Real Parties in Interest to a Third Party Request for an Ex ParteReexamination" (Docket No. PTO-P-2025-0545)
Adeia Inc. ("Adeia") submits these comments in response to the U.S. Patent and Trademark Office ("USPTO" or "Office") Notice of Proposed "Requirement to Identify All Real Parties in Interest to a Third Party Request for an Ex Parte Reexamination" [Docket No. PTO-P-2025-0545] RIN 0651-AD94, 91 Fed. Reg. 46,038-42 (July 22, 2026) ("Proposed Rule").
I.
BACKGROUND
Adeia is a publicly traded, U.S.-based research and development ("R&D") technology company headquartered in Silicon Valley (NASDAQ: ADEA). Adeia invents, develops, and accelerates the adoption of next-generation technologies for the semiconductor and media industries. Adeia is among the most innovative companies in America, ranking in the Top 30 U.S. companies granted the most U.S. patents last year. In 2025, Adeia invested $67 million into R&D, representing more than 15% of its annual revenue. Adeia's advanced semiconductor R&D includes hybrid bonding and thermal management technologies critical to the development of artificial intelligence ("AI") and data center infrastructure. Adeia's media technologies include leading-
See Intellectual Property Owners Ass'n & Harrity Analytics, Top 300 Organizations Granted U.S. Patents in 2025, 43rd Annual Listing (June 15, 2026), available at https://ipo.org/wp-content/uploads/2026/06/2026-IPO-Top-Patent-Owners-List.pdf (ranking Adeia #66 among all organizations worldwide, and among the top 30 U.S.-headquartered companies, to be granted the most U.S. patents in 2025). Adeia was granted more patents last year than HP, AMD, Meta, Broadcom, and many other technology leaders. See, e.g., Yole Group, Hybrid Bonding & Latest Advancements in 2.5D/3D Packaging Industry (Feb. 27, 2025), available at https://www.yolegroup.com/player-interviews/hybrid-bonding-latest-advancements-2-5d-3d-packaging-industry-an-interview-with-adeia/ ("ADEIA is the market leader in providing innovations for hybrid bonding. At the heart of AI, data center, and HPC [high-performance computing], is massively parallel processing of bits, which requires scaling the interconnect to finer pitches for high bandwidth, low power interfaces. Hybrid bonding is the core technology to make this interconnect a reality."); 3DInCites, An Integrated Cooling Solution for Hot Chips (June 4, 2025), available at https://www.3dincites.com/2025/06/an-integrated-cooling-solution-for-hot-chips/ ("Adeia's Integrated Cooling Solution represents a paradigm shift in semiconductor thermal management. By eliminating the TIM layer and leveraging advanced silicon bonding techniques, ICS delivers improved thermal efficiency-reducing chip temperatures, increasing reliability-to enabling higher computational chipsets for AI-centric data centers."); see also Storagenewsletter.com, FMS 2025: Best of Show Award Winners 2025 (Aug. 7, 2025) (Adeia's hybrid bonding technology awarded "Most Innovative Technology" in the 3D Memory Technology edge advancements in video streaming, as well as pioneering AI solutions that enable media and entertainment platforms to deliver more immersive experiences. Adeia holds over 14,000 U.S. and foreign patents and patent applications, and is a major stakeholder in the U.S. patent system.
Adeia applauds USPTO leadership for recognizing the need for the Proposed Rule. Adeia supports the Proposed Rule, with one recommended change noted in Part II.B below.
II.
ADEIA COMMENTS
A.
Adeia Has Experienced a Surge of Anonymous EPR Requests.
The Proposed Rule's observation that "[t]he Office is currently receiving a significant number of ex parte reexamination ['EPR'] requests" is consistent with Adeia's experience. Adeia is not aware of having received a single EPR request against any of its patents for more than a decade prior to October 2025. But in the six months that followed, Adeia received notice of 10 EPR requests-all filed anonymously:
Patent # Application # EPR Filing Date Law Firm Filing EPR Real Party in Interest
9,690,833 90/015,568 Oct. 1, 2025 Holzer Patel Drennan Anonymous
7,890,490 90/015,595 Oct. 10, 2025 Holzer Patel Drennan Anonymous
8,949,231 90/015,617 Oct. 22, 2025 Holzer Patel Drennan Anonymous
8,516,524 90/015,815 Dec. 22, 2025 Holzer Patel Drennan Anonymous
8,825,576 90/015,823 Dec. 23, 2025 Holzer Patel Drennan Anonymous
10,965,726 90/015,822 Dec. 23, 2025 Holzer Patel Drennan Anonymous
8,375,069 90/015,868 Jan. 8, 2026 Holzer Patel Drennan Anonymous
9,355,182 90/015,896 Jan. 20, 2026 Holzer Patel Drennan Anonymous
10,931,992 90/015,979 Feb. 19, 2026 Holzer Patel Drennan Anonymous
9,223,873 90/016,116 Apr. 1, 2026 Holzer Patel Drennan Anonymous
In each instance in which reexamination was ordered, Adeia was forced to defend its duly issued patent without knowing whether the requester is a current or prospective licensee, a competitor, an affiliate of a previously estopped party, a party acting at the direction of another entity, or a foreign-backed entity.
category), available at https://www.storagenewsletter.com/2025/08/07/fms-2025-best-of-show-award-winners-2025/. See Business Intelligence Group, AI Breakthroughs of 2025 - Celebrating the Visionaries, Innovators & Trailblazers of the Artificial Intelligence Excellence Awards (Mar. 25, 2025), available at https://www.bintelligence.com/posts/ai-breakthroughs-of-2025-celebrating-the-visionaries-innovators-and-trailblazers-of-the-artificial-intelligence-excellence-awards (recognizing Adeia for its "remarkable contributions to the AI industry"). Proposed Rule, 91 Fed. Reg. 46,039. See also RPX, Reexams Surge Again in Q1-Prompting USPTO to Take Limiting Measures (May 27, 2026) ("The first quarter saw a particularly large spike in filings, going up by 190% compared to Q1 2025."), available at https://www.rpxcorp.com/data-byte/reexams-surge-again-in-q1-prompting-uspto-to-take-limiting-measures/.
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Adeia agrees with the Proposed Rule's goals of allowing the Office to assess whether an estoppel applies and to identify mistakes or misrepresentations in the certification. But disclosure to the Office alone would solve only part of the problem. As the Proposed Rule recognizes, real party in interest ("RPI") status may be disputed and is highly fact-dependent. A patent owner may have relationship, licensing, litigation, or public-record evidence bearing on whether the requester's disclosure is complete and accurate. The final rule should also permit the patent owner, and to the fullest extent consistent with law, the public, to learn the RPI's identity and bring relevant evidence to the Office's attention.
B.
Adeia Recommendation: The RPI's Identity Should Also Be Disclosed to the Public, or at Minimum, to the Patent Owner.
The Proposed Rule would permit disclosure of the RPI only to the Office, and suggests it is legally required or desirable from a policy standpoint to keep the RPI's identity secret from the public and patent owner. Adeia urges the Office to consider this further.
Adeia believes that greater RPI transparency is both legally permissible and better policy. As discussed further below, the statutory text does not expressly require secrecy for EPR RPIs; the original rationale for keeping the RPI's identity secret has been refuted by well over a decade of empirical evidence; and the Office has recognized the benefits of greater RPI transparency in other contexts.
Adeia's specific recommendation is that in proposed Sec. 1.510(b)(7), the final rule not include the sentence, "Upon the written request of the third party requester, the statement will be excluded from the patent and reexamination files and kept confidential":
Sec. 1.510 Request for ex parte reexamination.
* * * * *
(b) * * *
(7) A separate statement by the third party requester identifying all real parties in interest to the ex parte reexamination request. The statement must be submitted according to the parameters established by the Office. Upon the written request of the third party requester, the statement will be excluded from the patent and reexamination files and kept confidential.
Alternatively, Adeia recommends that the Office make clear that the phrase "kept confidential" permits disclosure not only to the Office, but also to the patent owner, on a confidential basis.
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1.
Sections 301(e) and 302 Do Not Require Confidentiality for EPR RPIs or Prevent Disclosure to the Patent Owner.
The only statute the Proposed Rule cites as requiring public anonymity of the RPI is 35 U.S.C. Sec. 301(e). Section 301 governs third party submissions citing prior art and prior written admissions of the patent owner that the third party wishes to be included in the patent file. It provides: "Upon the written request of the person citing prior art or written statements pursuant to subsection (a), that person's identity shall be excluded from the patent file and kept confidential."
But the Proposed Rule and the statute distinguish such "mere citations of prior art and written statements" under Section 301 from EPR requests, which are governed by Section 302. Section 301 does not refer to Section 302 or state that the identity of an EPR requester proceeding under Section 302 must be kept confidential. To the contrary, the plain text of Section 301 only requires that the identity of someone who files a written submission "pursuant to subsection (a) [of Section 301]" be kept confidential. 35 U.S.C. Sec. 301(e).
Nor does Section 302 itself include any provision requiring confidentiality of an RPI's identity. Section 302 provides that any third party can make an EPR request based on prior art cited under Section 301, but does not state that the confidentiality provisions of Section 301 would govern such a request. It simply says that an EPR requester can cite the prior art that was previously identified in a Section 301 submission. As such, mere citations of prior art and written statements submitted under Section 301 can remain anonymous, but when a third party takes the additional step of requesting reexamination under Section 302, the statutory text does not require that the requester's identity remain confidential. Not only that, Section 302 suggests the opposite, stating "[u]nless the requesting person is the owner of the patent, the Director promptly will send a copy of the request to the owner of record of the patent." 35 U.S.C. Sec. 302. This requirement to send the EPR request to the patent owner does not include any carve-out for the RPI's identity, such as a mandate that the identity be kept confidential or be redacted.
The Proposed Rule further cites Section 301's implementing regulation at 37 CFR Sec. 1.501(d), which provides that, "[i]f the person making the submission wishes his or her identity to be excluded from the patent file and kept confidential, the submission papers must be submitted anonymously without any identification of the person making the submission." But again, this only applies to submissions under Section 301. And the Proposed Rule would make it clear that Section 1.501(d) is limited to such "mere citations of prior art and written statements" under Section 301, and would not apply to EPR requests. The implementing regulations for EPRs are Sections 1.525-1.565, and none of those sections addresses the confidentiality of the requester's identity.
See Proposed Rule, 91 Fed. Reg. 46,040 ("Proposed Sec. 1.501(d) would be revised to clarify that papers submitted 'under this section' (i.e., mere citations of prior art and written statements) can be submitted anonymously without any identification of the person making the submission. The language 'under this section' would be added to distinguish citations of prior art and written statements submitted under Sec. 1.501, which may still be submitted anonymously, from ex parte reexamination requests under Sec. 1.510, which would now require identification of all real parties in interest to the request.").
Ibid.
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If the Office nonetheless concludes that 35 U.S.C. Sec. 301(e) applies to Section 302 and requires an EPR requester's identity to remain outside the public patent file, Adeia alternatively recommends that the final rule at least permit disclosure of the RPI's identity to the patent owner under reasonable confidentiality and use safeguards, and establish a procedure for the patent owner to submit evidence concerning the statement's completeness and any applicable estoppel. This is legally permitted under the same rationale as the Proposed Rule's rationale for disclosing the RPI to the Office. The Proposed Rule states that Section 301(e) "only requires keeping the requester's identity confidential from the public, not from the Office." But Section 301(e) does not actually refer to "the public." It states that the requester's identity "shall be excluded from the patent file and kept confidential." 35 U.S.C. Sec. 301(e). Accordingly, if this language is interpreted to permit disclosure to the Office, the same interpretation would permit disclosure to the patent owner: the RPI's identity could still be excluded from the patent file, but disclosed to the patent owner confidentially.
2.
The Original Rationale for Maintaining RPI Anonymity Has Proven to Be Unfounded.
The Proposed Rule cites legislative history from nearly 50 years ago and public comments from 2012 as evidence of the asserted need to keep an RPI's identity secret from the public. But the original hypothetical worry-that disclosing an RPI's identity would supposedly chill a third party's willingness to file an EPR-has been substantially undermined by nearly fourteen years of experience under the AIA. One only has to look at inter partes reviews ("IPRs") to see that public RPI disclosure has not prevented widespread use by third-party patent challengers. Unlike EPR requesters, an IPR petitioner must disclose all RPIs. Despite that requirement, IPRs rapidly became, and for more than a decade remained, "the most-used type of post-grant proceeding introduced by the AIA by an overwhelming margin" and "the dominant mechanism for challenging issued U.S. patent claims." That would simply not be the case if disclosing the filer's identity had a chilling effect. The sustained level of use is powerful evidence that RPI disclosure does not materially deter legitimate patent challenges.
Id., 91 Fed. Reg. 46,039.
See ibid. (citing 1980 legislative history at H.R. Rep. 96-1307, 6, 1980 U.S.C.C.A.N. 6460, 6465; and citing Comments 20 and 25 to the August 2012 Final Rule, 77 Fed. Reg. at 46621).
Congressional Research Service, R48016, The Patent Trial and Appeal Board and Inter Partes Review, at 11 (2024), available at https://www.congress.gov/crs-product/R48016.
Patently-O, Decimation: Ex Parte Reexamination Eclipses the IPR (May 2, 2026), available at https://patentlyo.com/patent/2026/05/decimation-ex-parte-reexamination-eclipses-the-ipr.html. In IPRs' first five years of operation, filings more than tripled, surging from 514 petitions in the first full fiscal year (FY2013) to 1,812 petitions in FY2017. This elevated level of filings stayed relatively consistent over the following years, with 1,361 IPR petitions filed in FY2025, more than 21/2 times the FY2013 level. See U.S. Patent & Trademark Office, PTAB Trial Statistics: FY25 End of Year Outcome Roundup, at 3 (2025), available at https://www.uspto.gov/sites/default/files/documents/Trial_StatsFY25_Q4.pdf; U.S. Patent & Trademark Office, Trial Statistics: IPR, PGR, CBM, at 5 (Sept. 2017), available at https://www.uspto.gov/sites/default/files/documents/Trial_Stats_2017-09-30.pdf; U.S. Patent & Trademark Office, Patent Trial and Appeal Board Statistics, at 4 (Sept. 30, 2015), available at https://www.uspto.gov/sites/default/files/documents/2015-09-30%20PTAB.pdf.
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3.
Public Policy Favors Disclosing an RPI's Identity to the Patent Owner and Public.
There are many strong public policy reasons for greater RPI transparency, which the Office has recognized in other contexts.
a.
Efficient resolution of licensing and other disputes.
If the patent owner knew the RPIs behind EPRs, it could facilitate the efficient resolution of licensing discussions or other disputes. The Office's Consolidated Trial Practice Guide explains that, at a general level, the RPI in an AIA proceeding is "the party that desires review of the patent," which may include "the party or parties at whose behest the petition has been filed." Identifying the parties who actually desire review of a patent can enable the patent owner to engage directly with the entities having underlying commercial interests in the dispute, including through licensing discussions or other consensual resolution. Early resolution of disputes could avoid additional EPRs or other legal proceedings being filed, conserving resources of the parties, the Office, and potentially courts or other administrative agencies.
This same efficiency rationale has been recognized in the related debate over transparency concerning third-party litigation funding. In a March 2026 submission to the federal Advisory Committee on Civil Rules proposing mandatory disclosure of third-party litigation funding, the U.S. Chamber of Commerce and Lawyers for Civil Justice explained that disclosure enables courts and parties to understand who they are actually negotiating with and who has settlement authority. They identified among the consequences of nondisclosure courts' inability to manage settlement conferences effectively, parties wasting time negotiating with nominal parties who lack authority, litigation continuing at the behest of hidden funders despite the parties' desire to settle, and surreptitious violations of confidentiality orders. The Advisory Committee itself identified "whether a funder should be involved in settlement conferences" and "whether a funder has influence or even a veto power over settlement" as potential purposes of third-party litigation funding transparency.
b.
Adjudicative integrity.
RPI disclosure to patent owners can also improve the Office's ability to identify duplicative proceedings, statutory or collateral estoppel, and other issues implicated by the filing. Recent Director Review decisions demonstrate the important role that patent owners can play in that inquiry. In Yangtze Memory Technologies Co. v. Micron Technology, Inc., the Director vacated institution after the patent owner presented evidence sufficient to place the petitioner's RPI identification in dispute and the petitioner failed to rebut that evidence. Similarly, in the precedential Tianma Microelectronics Co. v. LG Display Co. decision, evidence presented by the patent owner placed in dispute both whether all RPIs had been identified and whether an RPI was a foreign government. In both cases, evidence presented by the patent owner assisted the Office in determining whether the petitioner had satisfied the RPI requirement.
Patent owners are particularly well positioned to provide such information because they know the parties with whom they are engaged in licensing discussions and other patent disputes. For example, a patent owner may know facts indicating that a requester is affiliated with an estopped party; that an RPI disclosure is incomplete or inaccurate; that the request is being funded or directed by another entity; or that confidential information from licensing discussions has been used in preparing the reexamination request. Keeping the disclosed RPIs secret from the patent owner deprives the Office of precisely the type of information that its recent RPI decisions demonstrate patent owners can provide.
c.
National security.
In a memorandum to all PTAB judges dated October 28, 2025, Director Squires reinstated the strict requirement that IPR petitioners identify all RPIs behind their petitions before institution, designating as precedential Corning Optical Communications RF, LLC v. PPC Broadband Inc., IPR2014-00440, Paper 68 (PTAB Aug. 18, 2015). The Director noted that inadequate RPI disclosure presents significant national-security concerns because opaque investment structures can permit foreign adversaries and state-linked entities to finance or direct U.S. patent challenges, including in strategically important technologies such as semiconductors and AI. He concluded that "the RPI requirement functions not merely as a procedural safeguard, but as a national-security measure," and that "[t]he integrity of PTAB proceedings depends on knowing who is behind a petition-who funds it, directs it, and/or benefits from it."
Yangtze Memory Technologies Co., Ltd. v. Micron Technology, Inc., IPR2025-00098, IPR2025-00099, Paper 38 (PTAB Jan. 15, 2026) (Director Review Order vacating decisions granting and denying institution), available at https://www.uspto.gov/sites/default/files/documents/ipr2025-00098_paper38.pdf. Tianma Microelectronics Co., Ltd. v. LG Display Co., Ltd., IPR2025-01579, Paper 12 (PTAB Mar. 18, 2026) (precedential), available at https://www.uspto.gov/sites/default/files/documents/IPR2025-01579Paper12.pdf.
See Oct. 28, 2025 Memorandum from John A. Squires to All PTAB Judges, "Precedential Designation of Corning Optical Communications RF, LLC v. PPC Broadband Inc., IPR2014-00440, Paper 68 (PTAB Aug. 18, 2015)" (except for Sec. II.E.1), available at https://www.uspto.gov/sites/default/files/documents/Precedential_designation_of_Corning_Optical_Communications_RF_LLC_v._PPC_Broadband_Inc_Memo_-_Dated_10_28_25.pdf.
Id. at 2.
Id. at 4.
The same national-security considerations apply to RPI transparency in EPR proceedings. U.S. patent owners should not be required to defend their patents through an administrative proceeding while being denied knowledge of whether the entity behind that proceeding is affiliated with, controlled by, or acting on behalf of a foreign government or other foreign interest. The Director observed in his Memorandum that "parties on the Department of Commerce 'entity list,' i.e., parties 'involved in activities that are contrary to the national security or foreign policy interests of the United States'-have filed a substantial and increasing number of IPRs." Because EPR requesters currently may remain anonymous, neither the Office nor patent owners can determine whether these same actors are also using EPRs to challenge U.S. patents-a problem exacerbated by the recent EPR surge. Indeed, of the 10 EPRs that have been filed anonymously against Adeia patents in the past several months, neither Adeia nor the Office knows whether the filings were made at the behest of a foreign state or an entity backed by a foreign state.
d.
Public confidence in the U.S. patent system.
Greater RPI transparency also promotes public confidence in the U.S. patent system. As Director Squires observed, opacity concerning who funds, directs, or benefits from patent challenges can "undermine public confidence in the integrity of the patent system." That concern is not limited to IPRs. EPRs can result in cancellation or amendment of issued patent rights, and the public has a legitimate interest in knowing the parties whose interests are driving those proceedings. Public RPI disclosure would provide accountability for the use of an important governmental process, while placing EPRs on a more consistent footing with IPRs, where RPI identities are publicly disclosed. There is no apparent policy reason why transparency concerning the identity of the parties behind a patent challenge should depend on which Office proceeding they select.
III.
CONCLUSION
Adeia commends the Office on its leadership in developing the Proposed Rule. Adeia supports the Proposed Rule, but urges the Office also to require public disclosure of the identity of every RPI behind a third-party EPR request. At minimum, the final rule should require disclosure to the patent owner under appropriate confidentiality safeguards and provide a meaningful procedure for the patent owner to submit evidence concerning RPI completeness and estoppel.
Respectfully submitted,
ADEIA INC.
Michael C. Spillner
Head of Government Affairs and Public Policy
michael.spillner@adeia.com
Id. at 2-3.
Id. at 4.
*
Original text of letter here: https://www.regulations.gov/comment/PTO-P-2025-0545-0014
Alaska Center Environmental Group Urges EPA to Maintain Public Participation Protections Against Deregulation of Minor Pollution Sources
Carter Struck
WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
TO:
U.S. Environmental Protection Agency
FROM:
The Alaska Center
DATE:
August 20, 2026
RE:
Docket ID No. EPA-HQ-OAR-2025-1212
The Alaska Center is a nonprofit organization working to engage, empower, and elect Alaskans to stand up for our clean air and water, healthy communities, and a strong democracy. On behalf of our members and supporters, we submit the following comments.
We strongly urge the Environmental ... Show Full Article WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. TO: U.S. Environmental Protection Agency FROM: The Alaska Center DATE: August 20, 2026 RE: Docket ID No. EPA-HQ-OAR-2025-1212 The Alaska Center is a nonprofit organization working to engage, empower, and elect Alaskans to stand up for our clean air and water, healthy communities, and a strong democracy. On behalf of our members and supporters, we submit the following comments. We strongly urge the EnvironmentalProtection Agency (EPA) not to revise public participation regulatory requirements around minor sources of pollution. This proposal comes on the heels of numerous rollbacks to deregulate air quality standards nationwide.
Public participation is a fundamental component of our democracy. It ensures decision-making processes are sound and transparent. Rather than treating process and review as an obstacle, we should encourage local knowledge, expertise, and concerns as an investment in any development project.
According to the proposal, minor forms of pollution can include industrial facilities, rock crushers, and metal recyclers among other projects. The phrase "minor" fails to capture the size of a project, or its impacts on the environment and surrounding area. In the same vein, it fails to recognize the collective impact of multiple minor sources of pollution. For example, multiple large diesel or natural-gas generators, another form of minor pollution under the Clean Air Act, are often used to power data centers. The combined imprint of multiple generators in close proximity does not fall within the scope of inconsequential air pollution. Regulatory definitions in this case fail to contribute any meaningful metrics to base public participation against.
A particularly concerning element of the EPA proposal is the removal of a federal minimum requirement for public notice. Advance notice is fundamental for effective public participation to take place. Communities' first notice of a new pollution source should not be when construction breaks ground. Given that "minor" is a poor indicator of the impacts residents will see to their air quality, all residents should have proper information about health risks associated with pollution in order to make decisions for themselves and their families. This includes community members with pre-existing health conditions, including those living with respiratory issues.
In summary, we value the health and well-being of our people and natural resources in Alaska. The EPA's proposal runs against our values and the agency's mission to protect human health and the environment. On behalf of The Alaska Center, we strongly urge the EPA not to revise public participation regulatory requirements around minor sources of pollution.
Thank you for your attention on these critically important matters.
Jennifer Hyde
Federal Engagement Coordinator
The Alaska Center
jennifer@akcenter.org
*
Original text of letter here: https://www.regulations.gov/comment/EPA-HQ-OAR-2025-1212-0281
TO:
U.S. Environmental Protection Agency
FROM:
The Alaska Center
DATE:
August 20, 2026
RE:
Docket ID No. EPA-HQ-OAR-2025-1212
The Alaska Center is a nonprofit organization working to engage, empower, and elect Alaskans to stand up for our clean air and water, healthy communities, and a strong democracy. On behalf of our members and supporters, we submit the following comments.
We strongly urge the Environmental ... Show Full Article WASHINGTON, Aug. 23 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. TO: U.S. Environmental Protection Agency FROM: The Alaska Center DATE: August 20, 2026 RE: Docket ID No. EPA-HQ-OAR-2025-1212 The Alaska Center is a nonprofit organization working to engage, empower, and elect Alaskans to stand up for our clean air and water, healthy communities, and a strong democracy. On behalf of our members and supporters, we submit the following comments. We strongly urge the EnvironmentalProtection Agency (EPA) not to revise public participation regulatory requirements around minor sources of pollution. This proposal comes on the heels of numerous rollbacks to deregulate air quality standards nationwide.
Public participation is a fundamental component of our democracy. It ensures decision-making processes are sound and transparent. Rather than treating process and review as an obstacle, we should encourage local knowledge, expertise, and concerns as an investment in any development project.
According to the proposal, minor forms of pollution can include industrial facilities, rock crushers, and metal recyclers among other projects. The phrase "minor" fails to capture the size of a project, or its impacts on the environment and surrounding area. In the same vein, it fails to recognize the collective impact of multiple minor sources of pollution. For example, multiple large diesel or natural-gas generators, another form of minor pollution under the Clean Air Act, are often used to power data centers. The combined imprint of multiple generators in close proximity does not fall within the scope of inconsequential air pollution. Regulatory definitions in this case fail to contribute any meaningful metrics to base public participation against.
A particularly concerning element of the EPA proposal is the removal of a federal minimum requirement for public notice. Advance notice is fundamental for effective public participation to take place. Communities' first notice of a new pollution source should not be when construction breaks ground. Given that "minor" is a poor indicator of the impacts residents will see to their air quality, all residents should have proper information about health risks associated with pollution in order to make decisions for themselves and their families. This includes community members with pre-existing health conditions, including those living with respiratory issues.
In summary, we value the health and well-being of our people and natural resources in Alaska. The EPA's proposal runs against our values and the agency's mission to protect human health and the environment. On behalf of The Alaska Center, we strongly urge the EPA not to revise public participation regulatory requirements around minor sources of pollution.
Thank you for your attention on these critically important matters.
Jennifer Hyde
Federal Engagement Coordinator
The Alaska Center
jennifer@akcenter.org
*
Original text of letter here: https://www.regulations.gov/comment/EPA-HQ-OAR-2025-1212-0281
ASDWA Urges EPA to Strengthen Alignment Between Contaminant Lists and Improve Communication for UCMR 6
Carter Struck
WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
ASDWA 1300 Wilson Boulevard Suite 875 Arlington, VA 22209
703-812-9505 info@asdwa.org www.asdwa.org
August 13, 2026
Ms. Jessica Kramer Assistant Administrator, Office of Water U.S. Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, DC 20460
Subject: Revisions to Establish the Sixth Unregulated Contaminant Monitoring Rule (UCMR 6) for Public Water Systems [Docket #EPA-HQ-OW-2023-0469]
Dear Ms. Kramer:
The ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. ASDWA 1300 Wilson Boulevard Suite 875 Arlington, VA 22209 703-812-9505 info@asdwa.org www.asdwa.org August 13, 2026 Ms. Jessica Kramer Assistant Administrator, Office of Water U.S. Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, DC 20460 Subject: Revisions to Establish the Sixth Unregulated Contaminant Monitoring Rule (UCMR 6) for Public Water Systems [Docket #EPA-HQ-OW-2023-0469] Dear Ms. Kramer: TheAssociation of State Drinking Water Administrators (ASDWA) is the professional non-profit association serving the administrators who lead the 57 state, tribal, and territorial drinking water primacy agencies. Primacy agencies are co-regulators with the Environmental Protection Agency (EPA) in the development and implementation of drinking water regulations under the Safe Drinking Water Act (SDWA). The primacy agencies' collective workforce of about 3,600 staff works tirelessly every day to ensure that the nation's 150,000 public water systems (PWS) provide safe drinking water every time consumers turn on the tap. ASDWA appreciates the opportunity to provide the perspective of primacy agencies on the proposed UCMR 6. These comments do not necessarily represent the specific views and concerns of individual primacy agencies, nor consensus from all members. EPA should consider individual comments from state primacy agencies, in addition to ASDWA's, to gain further perspective on this rulemaking.
UCMR Regulatory Process
ASDWA supports EPA's continued investigation of unregulated contaminants in UCMR 6. The UCMR program serves as a critical part of the regulatory development process established under Section 1412(b) of the Safe Drinking Water Act (SDWA) by developing robust national occurrence data. ASDWA has consistently supported the framework established by the 1996 SDWA Amendments, including the CCL, UCMR, Regulatory Determinations, and Six-Year Review. Given the purpose of this framework, ASDWA encourages EPA to maintain the intended connection between the CCL and UCMR so contaminant selection, monitoring, and data collection can appropriately support future decision making. Only eight of the 30 contaminants proposed in UCMR 6 were identified on CCL 5, and 14 of the 30 proposed contaminants have never appeared on a prior CCL. ASDWA recognizes EPA's authority to include non-CCL contaminants through its standard prioritization process. However, we recommend that EPA strengthen the alignment between CCL development and UCMR contaminant selection so that collected national occurrence data can thoroughly inform future Regulatory Determinations.
Selected Contaminants PFAS ASDWA appreciates EPA's inclusion of the seven ultrashort organofluorine compounds in the proposed UCMR 6, four of which are PFAS and three of which are similarly structured compounds. We support EPA's continued commitment to addressing PFAS in drinking water in line with the 2019 PFAS Action Plan and other recent federal actions. Microplastics ASDWA supports EPA's decision to exclude microplastics from the proposed UCMR 6. This decision is consistent with the contaminant prioritization process and the purpose of utilizing UCMRs to collect occurrence data on contaminants with a validated analytical method at the time of publication. ASDWA encourages EPA to continue applying this same level of analytical discipline in future UCMR contaminant selection. ASDWA also recognizes the significant public interest in and concern about microplastics in drinking water. Accordingly, ASDWA supports EPA's commitment to further research microplastics and contaminant characteristics. This research, alongside the development of a well-vetted, validated analytical method and adequate lab capacity, is crucial to complete before microplastics are considered for a future UCMR. We recommend that EPA continue communicating with the public about potential health risks and the UCMR process in order to address public concern and clarify that the absence of microplastics from UCMR 6 does not reflect a lack of Agency attention to this issue. EPA listed microplastics and pharmaceuticals as two of four chemical groups on the proposed CCL 6. Since UCMRs are designed to collect occurrence data for individual contaminants, not broader chemical groups, EPA should expand upon the purpose of these groups and how they may impact UCMR contaminant selection and prioritization. Providing narrower definitions for these chemical groups would be conducive to identifying specific priority contaminants for monitoring and bridging the gap between CCLs, UCMRs, and Regulatory Determinations.
Contaminants from Previous UCMRs and Regulatory Determinations ASDWA appreciates EPA's explanation as to why 1,2,3,-trichloropropane (1,2,3-TCP) and chlorpyrifos oxon were included in the proposed UCMR 6 after being previously monitored in UCMR 3 and UCMR 4, respectively. The transparency around optimized analytical methods and justifications for new occurrence data provides valuable insight into the contaminant selection process. However, ASDWA observed that six other contaminants proposed for UCMR 6 have previously received negative regulatory determinations. Hexachlorobutadiene, naphthalene, and metribuzin each received a negative regulatory determination under Regulatory Determination 1 in 2003, while 1,1,2,2-tetrachloroethane, 2,4-dinitrotoluene, and 2,6-dinitrotoluene received negative regulatory determinations under Regulatory Determination 2 in 2008. ASDWA understands that EPA may have proposed these contaminants for UCMR 6 because a significant amount of time has passed since these regulatory determinations were made and optimized analytical methods are now available. Yet the rationale behind why these contaminants are being revisited is not apparent in the proposed UCMR 6, nor in the Information Compendium for Candidate Contaminants for the Proposed Sixth Unregulated Contaminant Monitoring Rule [Docket #EPA-HQ-OW-2023-0469-0139]. ASDWA recommends that EPA explicitly address why the six contaminants with previous regulatory determinations are being revisited and share what new health effects information, data, or analytical methods call for monitoring under UCMR 6.
Communication and Coordination with States on UCMR 6 ASDWA recommends that EPA prioritize early and consistent communication with state drinking water programs and water systems throughout the implementation of UCMR 6. Some states have noted that, in previous UCMR cycles, system contact information became outdated due to personnel changes by the time quarterly data was received by EPA's contractors. EPA should maintain reliable communication channels and up-to-date points of contact to support implementation. Furthermore, EPA should clearly define the roles and responsibilities of all parties involved in UCMR 6 implementation. Establishing clear expectations at the outset for states that have signed voluntary Partnership Agreements will prevent miscommunications among states, water systems, and EPA. Some states have also expressed interest in working with EPA to develop fact sheets for UCMR 6 contaminants with health reference levels, similar to fact sheets produced on lithium during UCMR 5. These materials would help primacy agencies and water systems interpret results and provide consistent messaging when responding to public inquiries about contaminants. Fact sheets could be especially relevant for contaminants that have generated significant public interest, e.g., the selected PFAS compounds, or, alternatively, discuss how UCMR monitoring fits into the larger SDWA regulatory process and share information about contaminants that were not selected for UCMR 6, like microplastics.
Data Management and Sampling Coordination ASDWA recommends that EPA coordinate with states before UCMR 6 monitoring begins to ensure that sampling information and data are compatible with SDWIS. Some states experienced challenges during UCMR 5 when inconsistent sampling IDs impacted entry into SDWIS and made it difficult to determine where samples had been collected. EPA should improve coordination on sampling data needs prior to implementation to prevent the need for significant staff time reformatting data or even resampling certain locations. In closing, ASDWA appreciates the opportunity to provide input on the proposed UCMR6 and hopes EPA takes this input into consideration when finalizing this proposed rule. We appreciate EPA's consideration of our comments and continued partnership. If you have any questions about these concerns or want to discuss comments further, please contact Lucy Terry (lterry@asdwa.org) or myself at aderosa@asdwa.org.
Sincerely,
Anthony DeRosa Executive Director Association of State Drinking Water Administrators (ASDWA)
CC: Jennifer McClain, OGWDW Eric Burneson, OGWDW
*
Original text of letter here: https://www.regulations.gov/comment/EPA-HQ-OW-2023-0469-0197
ASDWA 1300 Wilson Boulevard Suite 875 Arlington, VA 22209
703-812-9505 info@asdwa.org www.asdwa.org
August 13, 2026
Ms. Jessica Kramer Assistant Administrator, Office of Water U.S. Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, DC 20460
Subject: Revisions to Establish the Sixth Unregulated Contaminant Monitoring Rule (UCMR 6) for Public Water Systems [Docket #EPA-HQ-OW-2023-0469]
Dear Ms. Kramer:
The ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. ASDWA 1300 Wilson Boulevard Suite 875 Arlington, VA 22209 703-812-9505 info@asdwa.org www.asdwa.org August 13, 2026 Ms. Jessica Kramer Assistant Administrator, Office of Water U.S. Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, DC 20460 Subject: Revisions to Establish the Sixth Unregulated Contaminant Monitoring Rule (UCMR 6) for Public Water Systems [Docket #EPA-HQ-OW-2023-0469] Dear Ms. Kramer: TheAssociation of State Drinking Water Administrators (ASDWA) is the professional non-profit association serving the administrators who lead the 57 state, tribal, and territorial drinking water primacy agencies. Primacy agencies are co-regulators with the Environmental Protection Agency (EPA) in the development and implementation of drinking water regulations under the Safe Drinking Water Act (SDWA). The primacy agencies' collective workforce of about 3,600 staff works tirelessly every day to ensure that the nation's 150,000 public water systems (PWS) provide safe drinking water every time consumers turn on the tap. ASDWA appreciates the opportunity to provide the perspective of primacy agencies on the proposed UCMR 6. These comments do not necessarily represent the specific views and concerns of individual primacy agencies, nor consensus from all members. EPA should consider individual comments from state primacy agencies, in addition to ASDWA's, to gain further perspective on this rulemaking.
UCMR Regulatory Process
ASDWA supports EPA's continued investigation of unregulated contaminants in UCMR 6. The UCMR program serves as a critical part of the regulatory development process established under Section 1412(b) of the Safe Drinking Water Act (SDWA) by developing robust national occurrence data. ASDWA has consistently supported the framework established by the 1996 SDWA Amendments, including the CCL, UCMR, Regulatory Determinations, and Six-Year Review. Given the purpose of this framework, ASDWA encourages EPA to maintain the intended connection between the CCL and UCMR so contaminant selection, monitoring, and data collection can appropriately support future decision making. Only eight of the 30 contaminants proposed in UCMR 6 were identified on CCL 5, and 14 of the 30 proposed contaminants have never appeared on a prior CCL. ASDWA recognizes EPA's authority to include non-CCL contaminants through its standard prioritization process. However, we recommend that EPA strengthen the alignment between CCL development and UCMR contaminant selection so that collected national occurrence data can thoroughly inform future Regulatory Determinations.
Selected Contaminants PFAS ASDWA appreciates EPA's inclusion of the seven ultrashort organofluorine compounds in the proposed UCMR 6, four of which are PFAS and three of which are similarly structured compounds. We support EPA's continued commitment to addressing PFAS in drinking water in line with the 2019 PFAS Action Plan and other recent federal actions. Microplastics ASDWA supports EPA's decision to exclude microplastics from the proposed UCMR 6. This decision is consistent with the contaminant prioritization process and the purpose of utilizing UCMRs to collect occurrence data on contaminants with a validated analytical method at the time of publication. ASDWA encourages EPA to continue applying this same level of analytical discipline in future UCMR contaminant selection. ASDWA also recognizes the significant public interest in and concern about microplastics in drinking water. Accordingly, ASDWA supports EPA's commitment to further research microplastics and contaminant characteristics. This research, alongside the development of a well-vetted, validated analytical method and adequate lab capacity, is crucial to complete before microplastics are considered for a future UCMR. We recommend that EPA continue communicating with the public about potential health risks and the UCMR process in order to address public concern and clarify that the absence of microplastics from UCMR 6 does not reflect a lack of Agency attention to this issue. EPA listed microplastics and pharmaceuticals as two of four chemical groups on the proposed CCL 6. Since UCMRs are designed to collect occurrence data for individual contaminants, not broader chemical groups, EPA should expand upon the purpose of these groups and how they may impact UCMR contaminant selection and prioritization. Providing narrower definitions for these chemical groups would be conducive to identifying specific priority contaminants for monitoring and bridging the gap between CCLs, UCMRs, and Regulatory Determinations.
Contaminants from Previous UCMRs and Regulatory Determinations ASDWA appreciates EPA's explanation as to why 1,2,3,-trichloropropane (1,2,3-TCP) and chlorpyrifos oxon were included in the proposed UCMR 6 after being previously monitored in UCMR 3 and UCMR 4, respectively. The transparency around optimized analytical methods and justifications for new occurrence data provides valuable insight into the contaminant selection process. However, ASDWA observed that six other contaminants proposed for UCMR 6 have previously received negative regulatory determinations. Hexachlorobutadiene, naphthalene, and metribuzin each received a negative regulatory determination under Regulatory Determination 1 in 2003, while 1,1,2,2-tetrachloroethane, 2,4-dinitrotoluene, and 2,6-dinitrotoluene received negative regulatory determinations under Regulatory Determination 2 in 2008. ASDWA understands that EPA may have proposed these contaminants for UCMR 6 because a significant amount of time has passed since these regulatory determinations were made and optimized analytical methods are now available. Yet the rationale behind why these contaminants are being revisited is not apparent in the proposed UCMR 6, nor in the Information Compendium for Candidate Contaminants for the Proposed Sixth Unregulated Contaminant Monitoring Rule [Docket #EPA-HQ-OW-2023-0469-0139]. ASDWA recommends that EPA explicitly address why the six contaminants with previous regulatory determinations are being revisited and share what new health effects information, data, or analytical methods call for monitoring under UCMR 6.
Communication and Coordination with States on UCMR 6 ASDWA recommends that EPA prioritize early and consistent communication with state drinking water programs and water systems throughout the implementation of UCMR 6. Some states have noted that, in previous UCMR cycles, system contact information became outdated due to personnel changes by the time quarterly data was received by EPA's contractors. EPA should maintain reliable communication channels and up-to-date points of contact to support implementation. Furthermore, EPA should clearly define the roles and responsibilities of all parties involved in UCMR 6 implementation. Establishing clear expectations at the outset for states that have signed voluntary Partnership Agreements will prevent miscommunications among states, water systems, and EPA. Some states have also expressed interest in working with EPA to develop fact sheets for UCMR 6 contaminants with health reference levels, similar to fact sheets produced on lithium during UCMR 5. These materials would help primacy agencies and water systems interpret results and provide consistent messaging when responding to public inquiries about contaminants. Fact sheets could be especially relevant for contaminants that have generated significant public interest, e.g., the selected PFAS compounds, or, alternatively, discuss how UCMR monitoring fits into the larger SDWA regulatory process and share information about contaminants that were not selected for UCMR 6, like microplastics.
Data Management and Sampling Coordination ASDWA recommends that EPA coordinate with states before UCMR 6 monitoring begins to ensure that sampling information and data are compatible with SDWIS. Some states experienced challenges during UCMR 5 when inconsistent sampling IDs impacted entry into SDWIS and made it difficult to determine where samples had been collected. EPA should improve coordination on sampling data needs prior to implementation to prevent the need for significant staff time reformatting data or even resampling certain locations. In closing, ASDWA appreciates the opportunity to provide input on the proposed UCMR6 and hopes EPA takes this input into consideration when finalizing this proposed rule. We appreciate EPA's consideration of our comments and continued partnership. If you have any questions about these concerns or want to discuss comments further, please contact Lucy Terry (lterry@asdwa.org) or myself at aderosa@asdwa.org.
Sincerely,
Anthony DeRosa Executive Director Association of State Drinking Water Administrators (ASDWA)
CC: Jennifer McClain, OGWDW Eric Burneson, OGWDW
*
Original text of letter here: https://www.regulations.gov/comment/EPA-HQ-OW-2023-0469-0197
American Hospital Association Urges FDA to Clarify Regulations on Digital Health and AI Innovation
Carter Struck
WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
August 13, 2026
Michelle Tarver
Director
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Submitted Electronically
RE: FDA-2018-N-1910 Request for Input: Development of 21st Century Cures Act
Section 3060 Required Report
Dear Director Tarver,
On behalf of our nearly 5,000 member hospitals, health systems and other healthcare organizations, our ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 13, 2026 Michelle Tarver Director Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993 Submitted Electronically RE: FDA-2018-N-1910 Request for Input: Development of 21st Century Cures Act Section 3060 Required Report Dear Director Tarver, On behalf of our nearly 5,000 member hospitals, health systems and other healthcare organizations, ourclinician partners - including more than 270,000 affiliated physicians, 2 million nurses and other caregivers - and the 43,000 healthcare leaders who belong to our professional membership groups, the American Hospital Association (AHA) appreciates the opportunity to provide input on the Food and Drug Administration (FDA) report on the risks and benefits to health and safety that are associated with non-device software as required under Section 3060 of the 21st Century Cures Act.
Advancements in digital health technology, artificial intelligence (AI), wellness applications and wearable devices continue to transform care delivery. These changes pose novel questions on the applicability of medical device regulation. The AHA appreciates that the FDA has been updating its regulations and guidance on what constitutes a medical device and a non-device software function, including updated guidance on Clinical Decision Support (CDS) software and general wellness products released in January 2026.
1,2 However, the FDA can help advance additional innovation by further clarifying its guidance, particularly with respect to appropriate guardrails to ensure patient safety.
1
https://www.fda.gov/media/109618/download
2
https://www.fda.gov/media/90652/download
Director Michelle Tarver
August 13, 2026
Page 2 of 5
Specifically, we recommend that the FDA:
Permanently adopt CDS flexibilities that generate only one clinical recommendation.
Clarify its General Wellness Guidance, removing references to allowing non-device general wellness applications to make recommendations on escalation to a healthcare provider.
Continue to update guidance, education and other materials to account for novel AI applications, including generative AI.
Below are our detailed comments.
Clinical Decision Support Software
Hospitals and health systems have seen the benefits of CDS tools in supporting quality improvement, improving safety and increasing efficiency. Our members deploy CDS algorithms to analyze large amounts of clinical data to generate patient-specific care recommendations. These recommendations support provider decision-making but ultimately are only one of many inputs, including the healthcare professional's (HCP) own clinical judgment. The AHA has long urged that the FDA adopt policies that do not inadvertently impose barriers to CDS adoption.
Section 3060(a) of the Cures Act sought to deter over-regulation by establishing criteria to exempt this type of low-risk decision support software from FDA regulation while appropriately ensuring FDA's continued authority to regulate software that replaces rather than supports the HCP's decision-making. Section 520(o)(1)(E) outlines four criteria that would exempt manufacturers and developers from FDA oversight as medical devices:
Criterion 1: Not intended to acquire, process or analyze a medical image or signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system.
Criterion 2: Displaying, analyzing or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines).
Criterion 3: Supporting or providing recommendations to an HCP about prevention, diagnosis or treatment of a disease or condition.
Criterion 4: Intended for the purpose of enabling an HCP to independently review the basis for the recommendations that such software presents so that it is not the intent that the HCP rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.
The AHA supports the FDA's January 2026 guidance providing enforcement discretion for certain CDS software functions that produce only one clinical recommendation under Criterion 3. Specifically, the new guidance states: "If only one option is clinically appropriate and the software function otherwise meets all criteria under section 520(o)(1)(E), FDA intends to exercise enforcement discretion (meaning that FDA does not intend to enforce requirements under the FD&C Act) for such functions."
We respectfully urge the FDA to make this flexibility permanent in its guidance rather than treating it as enforcement discretion.
General Wellness Applications
Wellness, health and lifestyle technologies have expanded rapidly. These types of devices have the potential to support consumer engagement in healthy activities to prevent the onset of conditions, like chronic disease. Many of the FDA's updates to its general wellness product guidance provide appropriate flexibilities to support innovation. However, the AHA recommends two clarifications to help bolster patient safety.
First, the AHA recommends the FDA consider developing additional guidance and educational resources on labeling wellness products to help mitigate potential confusion for consumers. The latest general wellness product guidance document adds a section on potential exemption applicability for devices that provide physiological data. Specifically, the agency states: "FDA may consider certain products that use non-invasive sensing (e.g., optical sensing) to estimate, infer, or output physiologic parameters (e.g., blood pressure, oxygen saturation, blood glucose, heart rate variability) to be general wellness products when such outputs are intended solely for wellness uses."
Products could be treated as exempt from medical device regulations if they are not intended for the diagnosis, cure, mitigation, prevention or treatment of a disease or condition. However, for consumers, there can be confusion about the distinction between medical device and non-medical device applications that transmit similar types of physiological data, which have different validation processes and uses. We encourage the FDA to consider developing guidance addressing this potential issue in coordination with the Federal Trade Commission (FTC). The FTC has a broad mandate to prevent unfair or deceptive acts or practices, and the FTC and FDA share jurisdiction over marketing of certain health-related products (including devices).
Second, we encourage the FDA to either clarify or remove the guidance regarding allowing non-device general wellness applications to recommend escalation to a healthcare provider. The January 2026 guidance indicates that general wellness products may provide notifications to users on when follow-up with a clinician may be beneficial. Specifically, it states:
"For purposes of this guidance, a product may be considered a general wellness product even if it includes a notification informing a user that evaluation by a healthcare professional may be helpful when outputs fall outside ranges appropriate for general wellness use, provided that such notifications:
do not identify or name a specific disease or medical condition;
do not characterize the output as abnormal, pathological, or diagnostic;
do not include clinical thresholds, diagnoses, or treatment recommendations; and
do not provide ongoing alerts or monitoring intended to manage a disease or condition."
A wellness product that provides feedback on ranges that are "outside ranges appropriate for general wellness use" may inadvertently expand a product's scope beyond its intended use. Additionally, it is unclear how either consumers or healthcare providers can use a recommendation to consult a clinician if the wellness product also cannot state the reading is abnormal, what thresholds for escalation it is using or what potential medical issue is being detected. We recommend the FDA consider addressing these issues in additional guidance or remove the section altogether.
Artificial Intelligence
While the request for information focuses on non-device software applications, we do want to take the opportunity to reiterate comments we made previously on AI-enabled devices.3 AI-enabled devices offer tremendous promise for improved patient outcomes and quality of life. At the same time, they also pose novel challenges - including model bias, hallucinations and model drift - that are not yet fully accounted for in existing medical device frameworks. AI tools are inherently designed to be agile and adaptive, taking in new data points, discerning patterns and continually updating to improve model accuracy. This is especially true for generative AI. As this technology continues to evolve, we anticipate there will continue to be questions about which applications constitute medical device versus non-device function.
In general, the AHA supports AI policy frameworks that balance flexibility to drive market-based innovations with appropriate safeguards to protect privacy and patient safety. As the FDA considers future policy approaches to measuring and evaluating AI-enabled medical device performance, we encourage the agency to:
Continue to develop educational materials, update guidance documents and provide FAQs with examples on medical device versus non-medical device applications.
Pursue risk-based post-deployment measurement and evaluation standards for AI-enabled medical device vendors and developers.
Synchronize measurement and evaluation activities with existing frameworks.
Align incentives and address infrastructure barriers to measurement and evaluation.
3
https://www.aha.org/lettercomment/2025-12-01-aha-letter-fda-ai-enabled-medical-devices
We look forward to working with the FDA to ensure the agency's regulatory approach to implementing Section 3060(a) prioritizes patient safety while allowing hospitals and health systems to continue to implement innovative tools. Please contact me if you have questions, or feel free to have a member of your team contact Jennifer Holloman, AHA director of health IT policy, at jholloman@aha.org.
Sincerely,
/s/
Ashley Thompson
Senior Vice President
Public Policy Analysis and Development
*
Original text of letter here: https://www.regulations.gov/comment/FDA-2018-N-1910-0383
August 13, 2026
Michelle Tarver
Director
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Submitted Electronically
RE: FDA-2018-N-1910 Request for Input: Development of 21st Century Cures Act
Section 3060 Required Report
Dear Director Tarver,
On behalf of our nearly 5,000 member hospitals, health systems and other healthcare organizations, our ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 13, 2026 Michelle Tarver Director Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993 Submitted Electronically RE: FDA-2018-N-1910 Request for Input: Development of 21st Century Cures Act Section 3060 Required Report Dear Director Tarver, On behalf of our nearly 5,000 member hospitals, health systems and other healthcare organizations, ourclinician partners - including more than 270,000 affiliated physicians, 2 million nurses and other caregivers - and the 43,000 healthcare leaders who belong to our professional membership groups, the American Hospital Association (AHA) appreciates the opportunity to provide input on the Food and Drug Administration (FDA) report on the risks and benefits to health and safety that are associated with non-device software as required under Section 3060 of the 21st Century Cures Act.
Advancements in digital health technology, artificial intelligence (AI), wellness applications and wearable devices continue to transform care delivery. These changes pose novel questions on the applicability of medical device regulation. The AHA appreciates that the FDA has been updating its regulations and guidance on what constitutes a medical device and a non-device software function, including updated guidance on Clinical Decision Support (CDS) software and general wellness products released in January 2026.
1,2 However, the FDA can help advance additional innovation by further clarifying its guidance, particularly with respect to appropriate guardrails to ensure patient safety.
1
https://www.fda.gov/media/109618/download
2
https://www.fda.gov/media/90652/download
Director Michelle Tarver
August 13, 2026
Page 2 of 5
Specifically, we recommend that the FDA:
Permanently adopt CDS flexibilities that generate only one clinical recommendation.
Clarify its General Wellness Guidance, removing references to allowing non-device general wellness applications to make recommendations on escalation to a healthcare provider.
Continue to update guidance, education and other materials to account for novel AI applications, including generative AI.
Below are our detailed comments.
Clinical Decision Support Software
Hospitals and health systems have seen the benefits of CDS tools in supporting quality improvement, improving safety and increasing efficiency. Our members deploy CDS algorithms to analyze large amounts of clinical data to generate patient-specific care recommendations. These recommendations support provider decision-making but ultimately are only one of many inputs, including the healthcare professional's (HCP) own clinical judgment. The AHA has long urged that the FDA adopt policies that do not inadvertently impose barriers to CDS adoption.
Section 3060(a) of the Cures Act sought to deter over-regulation by establishing criteria to exempt this type of low-risk decision support software from FDA regulation while appropriately ensuring FDA's continued authority to regulate software that replaces rather than supports the HCP's decision-making. Section 520(o)(1)(E) outlines four criteria that would exempt manufacturers and developers from FDA oversight as medical devices:
Criterion 1: Not intended to acquire, process or analyze a medical image or signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system.
Criterion 2: Displaying, analyzing or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines).
Criterion 3: Supporting or providing recommendations to an HCP about prevention, diagnosis or treatment of a disease or condition.
Criterion 4: Intended for the purpose of enabling an HCP to independently review the basis for the recommendations that such software presents so that it is not the intent that the HCP rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.
The AHA supports the FDA's January 2026 guidance providing enforcement discretion for certain CDS software functions that produce only one clinical recommendation under Criterion 3. Specifically, the new guidance states: "If only one option is clinically appropriate and the software function otherwise meets all criteria under section 520(o)(1)(E), FDA intends to exercise enforcement discretion (meaning that FDA does not intend to enforce requirements under the FD&C Act) for such functions."
We respectfully urge the FDA to make this flexibility permanent in its guidance rather than treating it as enforcement discretion.
General Wellness Applications
Wellness, health and lifestyle technologies have expanded rapidly. These types of devices have the potential to support consumer engagement in healthy activities to prevent the onset of conditions, like chronic disease. Many of the FDA's updates to its general wellness product guidance provide appropriate flexibilities to support innovation. However, the AHA recommends two clarifications to help bolster patient safety.
First, the AHA recommends the FDA consider developing additional guidance and educational resources on labeling wellness products to help mitigate potential confusion for consumers. The latest general wellness product guidance document adds a section on potential exemption applicability for devices that provide physiological data. Specifically, the agency states: "FDA may consider certain products that use non-invasive sensing (e.g., optical sensing) to estimate, infer, or output physiologic parameters (e.g., blood pressure, oxygen saturation, blood glucose, heart rate variability) to be general wellness products when such outputs are intended solely for wellness uses."
Products could be treated as exempt from medical device regulations if they are not intended for the diagnosis, cure, mitigation, prevention or treatment of a disease or condition. However, for consumers, there can be confusion about the distinction between medical device and non-medical device applications that transmit similar types of physiological data, which have different validation processes and uses. We encourage the FDA to consider developing guidance addressing this potential issue in coordination with the Federal Trade Commission (FTC). The FTC has a broad mandate to prevent unfair or deceptive acts or practices, and the FTC and FDA share jurisdiction over marketing of certain health-related products (including devices).
Second, we encourage the FDA to either clarify or remove the guidance regarding allowing non-device general wellness applications to recommend escalation to a healthcare provider. The January 2026 guidance indicates that general wellness products may provide notifications to users on when follow-up with a clinician may be beneficial. Specifically, it states:
"For purposes of this guidance, a product may be considered a general wellness product even if it includes a notification informing a user that evaluation by a healthcare professional may be helpful when outputs fall outside ranges appropriate for general wellness use, provided that such notifications:
do not identify or name a specific disease or medical condition;
do not characterize the output as abnormal, pathological, or diagnostic;
do not include clinical thresholds, diagnoses, or treatment recommendations; and
do not provide ongoing alerts or monitoring intended to manage a disease or condition."
A wellness product that provides feedback on ranges that are "outside ranges appropriate for general wellness use" may inadvertently expand a product's scope beyond its intended use. Additionally, it is unclear how either consumers or healthcare providers can use a recommendation to consult a clinician if the wellness product also cannot state the reading is abnormal, what thresholds for escalation it is using or what potential medical issue is being detected. We recommend the FDA consider addressing these issues in additional guidance or remove the section altogether.
Artificial Intelligence
While the request for information focuses on non-device software applications, we do want to take the opportunity to reiterate comments we made previously on AI-enabled devices.3 AI-enabled devices offer tremendous promise for improved patient outcomes and quality of life. At the same time, they also pose novel challenges - including model bias, hallucinations and model drift - that are not yet fully accounted for in existing medical device frameworks. AI tools are inherently designed to be agile and adaptive, taking in new data points, discerning patterns and continually updating to improve model accuracy. This is especially true for generative AI. As this technology continues to evolve, we anticipate there will continue to be questions about which applications constitute medical device versus non-device function.
In general, the AHA supports AI policy frameworks that balance flexibility to drive market-based innovations with appropriate safeguards to protect privacy and patient safety. As the FDA considers future policy approaches to measuring and evaluating AI-enabled medical device performance, we encourage the agency to:
Continue to develop educational materials, update guidance documents and provide FAQs with examples on medical device versus non-medical device applications.
Pursue risk-based post-deployment measurement and evaluation standards for AI-enabled medical device vendors and developers.
Synchronize measurement and evaluation activities with existing frameworks.
Align incentives and address infrastructure barriers to measurement and evaluation.
3
https://www.aha.org/lettercomment/2025-12-01-aha-letter-fda-ai-enabled-medical-devices
We look forward to working with the FDA to ensure the agency's regulatory approach to implementing Section 3060(a) prioritizes patient safety while allowing hospitals and health systems to continue to implement innovative tools. Please contact me if you have questions, or feel free to have a member of your team contact Jennifer Holloman, AHA director of health IT policy, at jholloman@aha.org.
Sincerely,
/s/
Ashley Thompson
Senior Vice President
Public Policy Analysis and Development
*
Original text of letter here: https://www.regulations.gov/comment/FDA-2018-N-1910-0383
American Association of Airport Executives: FAA Calls for Public Comments on Draft Airport Improvement Program Handbook
Carter Struck
WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
August 17, 2026
William Garrison
Acting Director
Office of Airport Planning and Programming
Federal Aviation Administration
800 Independence Ave., SW
Washington, DC 20591
RE:
Federal Aviation Administration; Request for Public Comment
Notice of Draft FAA Order 5100-38E, Airport Improvement Program Handbook
Docket No. FAA-2026-4006 (May 19, 2026)
Dear Mr. Garrison:
The American Association of Airport Executives ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 17, 2026 William Garrison Acting Director Office of Airport Planning and Programming Federal Aviation Administration 800 Independence Ave., SW Washington, DC 20591 RE: Federal Aviation Administration; Request for Public Comment Notice of Draft FAA Order 5100-38E, Airport Improvement Program Handbook Docket No. FAA-2026-4006 (May 19, 2026) Dear Mr. Garrison: The American Association of Airport Executives(AAAE), which represents over 12,000 members serving nearly 875 airports across the country, appreciates the opportunity to provide feedback in response to the Federal Aviation Administration's (FAA) request for public comment on draft FAA Order 5100.38E, "Airport Improvement Program Handbook" ("Draft AIP Handbook"), which is the primary guide for the FAA's funding of airport development projects under the Airport Improvement Program (AIP).1 The AIP is a critical funding program for airport sponsors to implement their capital programs, especially critical safety-enhancing airfield projects, and we are pleased to share our unique perspective on the proposed AIP Handbook update.
Introduction and Summary of Recommendations
We generally support the FAA's stated objectives with the Draft AIP Handbook, which include clarifying statutory requirements, eliminating redundancies, creating an easily updated structure, increasing opportunities for efficiency, and delegating more decision-making to FAA field offices.2 However, AAAE members expressed several concerns. First, despite countless hours reviewing the draft document, the lack of any change summary from the FAA made it difficult to understand the scope and nature of the changes and whether the document fulfills the FAA's stated objectives. Second, while we support delegating decision-making to FAA field offices, we are concerned that the recent reduction in FAA staffing may lead to slower review times and further delays than what airport sponsors already experience. Third, although we appreciate the FAA adopting several efficiency improvements, AAAE believes additional changes are needed to streamline the grantmaking process.1 Notice of Draft FAA Order 5100-38E, Airport Improvement Program Handbook, 91 Fed. Reg. 29247 (May 19, 2026) (request for public comment).2 Fed. Aviation Admin., Airport Improvement Program Handbook i-i (2026) (hereinafter "Draft AIP Handbook").
From AAAE's understanding of the proposed changes, we believe that the FAA should take the following actions to simplify certain AIP processes, improve the usability of the document, and ensure its stated objectives are accomplished:
The FAA should (a) provide a summary of changes made in the Draft AIP Handbook and an opportunity to comment on the changes and (b) educate airport sponsors on specific changes that the FAA adopts in the final document.
The FAA should eliminate or relax its requirement that airport sponsors demonstrate an "actual need" or justification for each proposed project before an AIP entitlement grant may be awarded. At the very least, the FAA should simplify determinations that certain types of projects have the necessary justification and an actual need.
The FAA should (a) limit the authority of field offices to require a benefit-cost analysis (BCA) for "any" project and (b) increase the threshold that determines when a BCA is required for a project.
The FAA should provide increased flexibility, discretion, and decision-making authority to FAA field offices to accelerate reviews, and airport sponsors must be given an appeal option in case that discretion is abused or applied inconsistently.
The FAA must ensure adequate staffing levels in its field offices commensurate with increased responsibilities so that the handbook's objectives are achieved.
The FAA should adopt the proposal to allow self-certification of eligible costs for terminal projects without limiting this self-certification option to projects that use $10 million or less in passenger facility charge (PFC) revenue.
The FAA should eliminate the new justification requirement that only allows AIP funding for reconstruction or rehabilitation of a primary runway if the runway is within 120 percent of the runway length needed by the airport's "critical aircraft" (unless a specific exception applies).
The FAA should eliminate the new noise exposure map (NEM) annual certification requirement as a condition of receiving a grant for a noise mitigation project and address other questions regarding required documentation to obtain a grant for these projects.
The FAA should (a) set deadlines for its field offices to complete the various reviews associated with AIP grants and (b) provide the expected review duration for each type of approval.
In addition to the recommendations provided in this letter, AAAE developed and provided dozens of other specific comments to the Draft AIP Handbook. Attached is an Excel spreadsheet with those comments, which are more detailed and intended to, among other things, identify ambiguous instructions to FAA field offices; identify conflicts between the draft document and statutes and other FAA guidance documents; improve the clarity and application of specific policies; and ensure airport sponsors understand various FAA requirements associated with securing AIP grants. Aside from our comments, we urge the FAA to continue to engage and communicate with AAAE and the industry as the agency transitions to Order 5100.38E. This will be important as airport sponsors need education on the updated handbook to ensure they understand the processes and requirements for access to critical AIP funding.
AAAE's Recommendations for FAA
Summary of AIP Handbook Changes
1. The FAA should (a) provide a summary of changes made in the Draft AIP Handbook and an opportunity to comment on the changes and (b) educate airport sponsors on specific changes that the FAA adopts in the final document.
One of the major concerns that AAAE heard from its members was the lack of any summary of changes between the current AIP Handbook (Order 5100.38D) and the Draft AIP Handbook (Order 5100.38E). On its website, the FAA has listed a "Draft Order 5100.38E, AIP Handbook: Key Updates (coming soon)" marker since the draft document was released in May.3 To date, the FAA has not posted any comparison of the two handbooks on its website despite the significance of the changes made. There are also no redlines included in the Draft AIP Handbook even though it is a complete rewrite and has 274 fewer pages than the version released in 2019. Overall, it has been very challenging for AAAE and the airport community to understand what changes have been made in the document, especially from a policy perspective. In light of these concerns, AAAE urges the FAA to release a summary of changes to the current AIP Handbook as soon as possible and offer another opportunity to comment on the changes that have been made. This could be in the form of a crosswalk document that details changes between current order and the draft document (similar to the Excel spreadsheet that was provided to industry when Change 1 to Order 5100.38D was released). The summary is necessary to help airport sponsors understand the Draft AIP Handbook, including changes incorporated from program guidance letters (PGLs) and other updated FAA documents. In addition, we highly encourage the FAA to engage with industry, through conferences and other forms of outreach, to answer questions and educate the community on the changes to ensure a successful transition to Order 5100.38E.
3. Fed. Aviation Admin., Draft AIP Handbook, Order 5100.38E (May 22, 2026), https://www.faa.gov/airports/aip/aip_handbook/draft.
Mr. William Garrison
August 17, 2026 | Page 4 of 12
Project Justification and Actual Need Requirements
2. The FAA should eliminate or relax its requirement that airport sponsors demonstrate an "actual need" or justification for each proposed project before an AIP entitlement grant may be awarded.
AAAE strongly disagrees with the FAA's position that an airport sponsor must demonstrate a justification and "actual need" to use AIP entitlement funds for an eligible project. In explaining its grant authority in the Draft AIP Handbook, FAA states that "if the FAA determines that a project is eligible and justified at that airport, then the FAA may fund the proposed project in whole or in part."4 For each proposed project, the justification test requires an FAA field office to ensure (a) the project advances an AIP policy; (b) an actual need for the project exists; and (c) the project scope is appropriate.5 FAA explains the test is a needs-based determination delegated to the agency by 49 U.S.C. Sec. 47103, which requires the development of the biennial National Plan of Integrated Airport Systems (NPIAS), and Sec. 47104, which grants the FAA the general authority to issue AIP grants "[t]o maintain a safe and efficient nationwide system of public-use airports that meets the present and future needs of civil aeronautics." Both the statutory framework and its legislative history confirm that Congress never intended to require airport sponsors to demonstrate project justification before receiving AIP entitlement funds. First, Congress did not require an airport sponsor to demonstrate an actual need in the statutes governing the issuance of grants. Under Sec. 47105, Congress allows a sponsor to apply for a grant if the sponsor (a) proposes a project for an airport identified in the NPIAS; (b) submits a proposed project description; (c) proposes an eligible "airport development" project, as defined in 49 U.S.C. Sec. 47102(3); (d) proposes a project that complies with any applicable FAA technical standards, such as airport lighting guidance; and (e) provides other information requested by the FAA.6 Section 47106 outlines the factors the FAA must consider when evaluating the application. While one of the criteria is for the FAA to ensure the project "contribute[s] to carrying out this subchapter," Congress has outlined its policies and priorities for AIP, which are extremely broad, such as improving airport safety, security, and capacity; protecting the environment; and minimizing noise impacts; among other things.7 Second, under the statute, there are only two extremely nuanced cases where FAA must apply a "justification" or "airside needs test" requirement for a proposed project.8 The omission of these requirements-from the specific grant application requirements in Sec. 47105, grant approval conditions in Sec. 47106, and other provisions in Title 49 of the U.S. Code-demonstrates that Congress's intent is to not require the FAA to determine whether an airport sponsor has an actual need or justification for a proposed project more generally. Third, while we recognize the FAA's need to understand the justification for a project before awarding a discretionary grant, this same rationale does not apply to entitlement grants. Under Sec. 47114, which governs apportionments (also known as entitlements), Congress provided that the Secretary of Transportation "shall" apportion funds to specific airports on an annual basis. If the project is eligible, and the airport sponsor has the statutory right to the funds, we do not believe it is appropriate for the FAA to impose a justification requirement that is not in the statute and that Congress never intended to apply. Moreover, Congress directed the FAA to "discourage" a sponsor from using entitlement funds for "lower priority projects by giving lower priority to discretionary projects" submitted by the sponsor (which has used its entitlement funds for such a low-priority project).9 This provision presupposes that airport sponsors were given the discretion to decide the most appropriate use for their entitlement funds, albeit with potential impacts on its discretionary fund requests. Fourth, the FAA's reliance on the NPIAS report requirement as the basis for the justification test and needs-based determination is misguided. Section 47103(a) provides that the NPIAS must "include the kind and estimated cost of eligible airport development the [FAA] considers necessary to provide a safe, efficient, and integrated system of public-use airports adequate to anticipate and meet the needs of civil aeronautics." The purpose of the NPIAS is not to limit the projects for which an airport sponsor may use AIP funding. A plain reading of Title 49 of the U.S. Code indicates that the NPIAS is used to help Congress budget and evaluate the full scope of infrastructure needs across the system, by FAA for planning purposes to promote the development of an integrated airport system,10 to determine the airports that are eligible to receive a grant,11 to limit the projects that may be funded by airports designated in the unclassified status,12 and to determine the annual apportionment amount for each non-commercial service airport.13 Moreover, nothing in the legislative history of the NPIAS requirement suggests it was designed to impose additional hurdles for an airport sponsor to obtain a grant for eligible projects. In 1982, Congress began requiring the FAA to develop the NPIAS, replacing the former National Airport System Plan (NASP).14 The major shift from the NASP to the NPIAS was for FAA to focus on "integrated airport systems." This was a major congressional policy priority at the time because of the need to develop and improve reliever airports to alleviate traffic congestion at major airport hubs and increase capacity in metropolitan areas.15 Indeed, Congress also directed FAA to fund grants for, and prioritize projects that are consistent with, "integrated airport system planning," which the law defined to mean "developing for planning purposes information and guidance to decide the extent, kind, location, and timing of airport development needed in a specific area to establish a viable, balanced, and integrated system of public-use airports."16 In short, the NPIAS was created to establish the scope of airports (existing and new) that are needed for an "integrated airport system" and eligible for grants and to provide information and guidance to a range of stakeholders for planning purposes. Separate from the statutory framework, we believe, as a matter of policy, that FAA staff should give substantial deference to the judgment of airport sponsors on the appropriateness of a proposed project. Airport sponsors are public in nature with a public mission and unique knowledge of the needs and requirements of the facilities for which they are responsible. They have decades of experience in successfully utilizing federal grant dollars for worthy projects that enhance safety and meet the other objectives specified by Congress and the agency. Sponsors report to AAAE incurring significant costs to justify and explain to the FAA why the project is needed and why the sponsor should be allowed to use funds that it is entitled to under the law. We do not believe this is an efficient use of limited resources, and sponsors need more flexibility in order to maintain and grow their facilities safely and efficiently. In addition, with the FAA experiencing a significant decrease in its staffing, we believe the agency has a unique opportunity to adapt and adjust its procedures to make the existing workload on staff more manageable. Thus, we urge the FAA to eliminate or relax its requirement that sponsors demonstrate an actual need or justification for each proposed project before an AIP entitlement grant may be awarded.
3. At the very least, the FAA should simplify determinations that certain types of projects have the necessary justification and an actual need.
AAAE disagrees with the FAA's position that an airport sponsor must demonstrate an actual need for a proposed project in order to use AIP entitlement funds, including any argument that Sec. 47103 requires such a determination. Notwithstanding, the FAA has discretion to instruct and simplify the process for FAA field offices to determine what constitutes an actual need for a proposed project to meet the criteria. Indeed, nothing in Title 49 of the U.S. Code defines how the FAA is expected to determine, for purposes of the NPIAS, what types of airport development projects are "necessary to provide a safe, efficient, and integrated system of public-use airports adequate to anticipate and meet the needs of civil aeronautics . . . ."17
17. 49 U.S.C. Sec. 47103(a).
Mr. William Garrison
August 17, 2026 | Page 7 of 12
AAAE urges the FAA to exercise its discretion and simplify the process for an FAA field office to make a determination that certain types of proposed projects have an actual need, including projects (a) that would be funded through an AIP entitlement grant or (b) where the federal share would be less than a specified threshold (e.g., 50 percent). If an airport sponsor is funding the majority of costs for a specific project, the FAA should presume there is an "actual need" for that project and the federal funds are not being used on a frivolous project. In such a case, a need-based determination is unnecessary, and the agency could simply presume projects falling into a certain category are necessary for meeting the needs of civil aeronautics.
4. The FAA should (a) limit the authority of field offices to require a BCA for "any" project and (b) increase the threshold that determines when a BCA is required for a project.
Under Sec. 47115(d), Congress only requires that the FAA consider a BCA before issuing a grant if (a) the project to be funded is for preserving and improving capacity and (b) the FAA is planning to use funds from its discretionary fund. No other types of projects receiving discretionary funds are required to undergo a BCA review.18 In the Draft AIP Handbook, the FAA provides that sponsors must prepare a BCA for capacity projects if it is requesting an amount of discretionary funding that exceeds a certain threshold. However, the FAA does not disclose the current threshold above which a sponsor must prepare a BCA for a project seeking discretionary funding.19 Separately, the FAA states that the agency "may" require a BCA for any other AIP project.20
We have two major concerns regarding the provisions on BCAs. First, if FAA field offices were given the authority to require a BCA for any project, regardless of funding amount, it would introduce new risks for an airport sponsor to execute a project in a reasonable timeframe. Any office could arbitrarily decide at any time that a project requires a BCA, even if the project has been in development for years and despite representations from staff that a BCA would not be required. This type of scenario could greatly extend a project's timeline. Second, ironically, many AAAE members expressed frustration with the high costs associated with preparing a BCA relative to its overall benefits in the case of most projects.
AAAE urges the FAA to make two changes to the directives on BCAs. First, the FAA should only require a BCA for projects for which Congress has directed the agency to evaluate the benefits and costs. This would only include capacity-enhancing projects receiving AIP discretionary funds. For all other projects, a BCA should remain optional supplemental information that an airport sponsor may provide if the sponsor believes it would help make the case to the FAA for a discretionary funding request. At the very least, the FAA should establish strict parameters for field offices when they may require a BCA to limit the overly broad discretion given to FAA field offices in the Draft AIP Handbook. Second, the FAA should increase the funding threshold that determines whether a BCA is required and index it for inflation.
18. See id. Sec. 47115(d)(2).19. Draft AIP Handbook, supra, at 2-10.20. Id. at 2-11.
Mr. William Garrison
August 17, 2026 | Page 8 of 12
FAA Field Office Authority
5. The FAA should provide increased flexibility, discretion, and decision-making authority to FAA field offices to accelerate reviews, and airport sponsors must be given an appeal option in case that discretion is abused or applied inconsistently.
As explained by the FAA in the preamble, one of the agency's stated objectives with the Draft AIP Handbook was to shift more decision-making and approvals to FAA field offices. AAAE is generally supportive of delegating increased authority to these offices, which would help accelerate reviews and approvals for airport sponsors. However, many AAAE members are concerned about the potential for abuse of that discretion or inconsistent application of the AIP across regions. An example is a case where one office approves a project grant while another office does not, despite factual circumstances being similar. Moreover, sponsors routinely report to AAAE that they are hesitant to elevate issues or concerns with decisions made by FAA field offices because of fear of retribution. Thus, we urge the FAA to establish and outline a procedure in the final handbook that allows sponsors to request further review from headquarters staff, without retribution or penalty, to ensure AIP policies and rules are consistently applied and in accordance with the intent of the agency.
6. The FAA must ensure adequate staffing levels in its field offices commensurate with increased responsibilities so that the handbook's objectives are achieved.
In 2025, the FAA experienced a significant reduction in staffing through deferred resignations, early retirements, and other initiatives. While safety-critical staff were exempt from the reductions, the agency reportedly lost a significant number of program managers, environmental protection specialists, and airport planners, among others, in the Office of Airports. These personnel are essential to facilitating the approvals required for sponsors to secure AIP grants, which provide vital funding for critical airport safety projects. Indeed, AAAE has received reports from its members that staffing issues at FAA have already led to delays with obtaining grant-related approvals. AAAE is concerned that the staffing reductions in FAA field offices, along with the increased decision-making authority, may lead to further delays in obtaining the necessary approvals. Therefore, we strongly urge the FAA to ensure that the agency has adequate local staff that is commensurate with their increased responsibilities.
Project-Specific Comments
7. The FAA should adopt the proposal to allow self-certification of eligible costs for terminal projects without limiting this self-certification option to projects that use $10 million or less in PFC revenue.
Under the Draft AIP Handbook, Appendix N outlines the eligibility and justification requirements for terminal development projects. These generally include projects within the terminal building and associated with the airside and landside areas that are directly related to the movement of passengers and baggage. Terminal projects typically have a mix of eligible and ineligible areas that require prorating the total project cost to properly allocate funding. (Costs are generally prorated using the ratio of eligible area to total area.) One notable change in the draft handbook is to streamline the process for determining allowable costs for terminal projects with both eligible and ineligible areas. Under the proposal, the FAA would allow airport sponsors (rather than FAA staff) to calculate and self-certify eligible costs if the sponsor is requesting that the FAA cover no more than 70 percent of the project's eligible costs.21
AAAE strongly supports the proposal to allow airport sponsors to self-certify eligible costs but urges the FAA to make one change. In Section N-2.2.1 of Appendix N, the FAA states that the self-certification option "may not be available" for airports that anticipate using more than $10 million in PFC funds for the project because they "are required to provide detailed basis of cost information."22 We believe this exception to the self-certification option should be eliminated. The $10 million cap would severely limit the availability of this option and would effectively prevent many larger airports from taking advantage of the expedited process. We do not believe the exception is necessary, and it is also unclear why the FAA established an arbitrary cap at $10 million. At the very least, the cap should be raised to $100 million (or $25 million to be consistent with the FAA's streamlined procedures for PFC authorizations).23
8. The FAA should eliminate the new justification requirement regarding primary runway reconstruction and rehabilitation projects (i.e., the 120-percent threshold).
Under the Draft AIP Handbook, Appendix B outlines the eligibility and justification requirements for projects associated with aircraft operational surfaces (AOS), including runways, taxiways, aprons, and taxilanes, among others. The draft document introduces a new justification requirement for runway reconstruction and rehabilitation projects that is not in the current AIP Handbook. Specifically, the FAA provides that full reconstruction or rehabilitation of a primary runway may only be conducted at its existing length if the runway is within 120 percent of the runway length needed by the airport's "critical aircraft," unless an exception applies.24 It is unclear why FAA added this 120-percent threshold, the rationale behind the policy change, and the intended application (including how it would apply to runways with existing dimensions that exceed current design needs). The provision also appears to focus only on runway length and does not address runway width. The consensus from AAAE members is that this new limitation is unnecessary and arbitrary and should be removed from the final handbook.
21. Draft AIP Handbook, supra, at N-10.22. Id.23. See Fed. Aviation Admin., PFC Update, PFC 73-20 (Jan. 22, 2020).24. Draft AIP Handbook, supra, at B-14.
Mr. William Garrison
August 17, 2026 | Page 10 of 12
9. The FAA should eliminate the new NEM annual certification requirement as a condition of receiving a grant for a noise mitigation project and address other questions regarding required documentation to obtain a grant for these projects.
Under the Draft AIP Handbook, Appendix I outlines the eligibility and justification requirements for airport noise compatibility programs under 14 C.F.R. pt. 150 and mitigation measures in an FAA environmental decision document for certain development projects. Table I-2.2 outlines "other considerations" for the FAA to fund a noise mitigation-related project. AAAE received many comments, concerns, and questions regarding the item, "Documentation is Current at Time of Each Funding Request," which discusses documentation from the airport sponsor that must be current to receive a noise mitigation project grant under AIP. The table states, in part:
"All documents for the implementation of remedial noise mitigation and noise abatement measures must be current at the time of each grant request. This includes [noise exposure maps (NEMs)]. In each year following the date of the FAA-accepted future NEM, sponsors must certify that the NEMs on file with the FAA accurately reflect current and projected operational conditions at the airport, sound insulation program implementation plans and acoustic test plans, and noise land inventory and reuse plans.
All maps that are five or more years old require written validation, which means the sponsor needs to explain why the accepted NEMs reflect the current or projected operational conditions at the airport for the associated noncompatible land uses. . . ." We have several concerns and questions regarding the item in Table I-2.2 on current documentation at the time of a funding request.
First, AAAE opposes the annual certification requirement regarding NEMs. The provision is not included in the current AIP Handbook, and the FAA has offered no explanation as to why an annual NEM certification is necessary or how this requirement differs from existing obligations. Indeed, Part 150 already requires airport sponsors to promptly prepare and submit a revised NEM to the FAA under certain conditions, including if a change in the operation of the airport creates a significant reduction in noise over existing noncompatible uses.25 We do not believe the certification requirement is necessary or appropriate and urge the FAA to remove it from the final handbook.
Second, we urge the FAA to clarify what specific documents must be current at the time of each grant request. Table I-2.2 states, "All documents for the implementation of remedial noise mitigation and noise abatement measures must be current at the time of each grant request. This includes NEMs." However, the FAA does not identify or discuss any other documents (besides NEMs) that need to be current. To prevent confusion, we recommend the FAA limit the applicability of the discussion to NEMs, unless the agency intended to discuss other documents that need to be current.
Third, we believe the FAA should update Table I-2.2 to provide a more comprehensive description of documentation that is required for an airport sponsor to receive a noise mitigation project grant under AIP. Sponsors should be provided with a reasonable understanding of the types of information that may be required during the grant application process. Sponsors have increasingly been asked to provide supplemental documentation that is not clearly identified in the current AIP Handbook or other existing guidance, such as information regarding specific neighborhoods proposed for testing or treatment within a noise contour. Clear handbook guidance would improve transparency, reduce uncertainty during project development, and promote more efficient grant processing.
Fourth, we believe the FAA should clarify the requirement that any NEM that is five or more years old requires "written validation" from the airport sponsor. Part 150 requires that NEMs be based "on forecast aircraft operations at the airport for a forecast period that is at least 5 years in the future."26 For a sponsor that developed an NEM with a forecast period greater than five years, it is unclear whether the validation requirement applies. We believe validation should only be required when a sponsor intends to use the NEM beyond the initial forecast period rather than an arbitrary fixed time (i.e., NEMs that are "five or more years old"). In addition, we believe the FAA should provide an estimated review timeline for this validation.
Deadlines and Expected FAA Review Timeframe
10. The FAA should (a) set deadlines for its field offices to complete the various reviews associated with AIP grants and (b) provide the expected review duration for each type of approval.
The FAA should implement deadlines for its staff to complete the various reviews associated with AIP grants and provide industry with an expected timeframe for field offices to complete those reviews. Before airport sponsors may receive an AIP grant, they must receive numerous approvals (or, in some cases, an FAA acceptance) associated with certain documents, including, but not limited to, airport layout plan (ALP) updates, aeronautical studies, aviation activity forecasts, airspace analyses, environmental analyses, modifications of standards, reimbursable agreements, construction safety and phasing plans (CSPPs), civil rights requirements, procurement processes, alternative project delivery contracts (if applicable), and grant applications. Unfortunately, FAA has never established deadlines for its staff or communicated expected review times to airport sponsors.
Under the current framework, the unpredictability of review timelines creates a bottleneck that stalls infrastructure projects, leaving airport sponsors unable to efficiently plan budgets, secure matching local funds, or begin projects during optimal construction seasons. Introducing deadlines and expected review times in the Draft AIP Handbook for each type of approval would lead to more accountability within FAA field offices, improve consistency of decision-making nationwide, enable sponsors to better plan and budget for their capital projects, and ensure that federal funds are deployed rapidly. Indeed, more transparent and predictable review process would allow airport sponsors to accelerate the delivery of critical-safety projects, expand capacity, and improve operational efficiency by reducing administrative delays.
* * *
AAAE appreciates the opportunity to provide comments on the Draft AIP Handbook. Please do not hesitate to reach out if you have any questions or require any additional information. I can be reached at justin.barkowski@aaae.org or at (703) 824-0504.
Sincerely,
Justin T. Barkowski
Legislative and Regulatory Counsel
Enclosure
Ensure Web Tools Remain Current
FAA discusses moving broadly applicable information about the AIP to the FAA's website. In addition, the FAA mentions an AIP funding tool that will also be on the website at the time of final publication. While AAAE is supportive of this approach and tool, we want to make sure the information online stays current and consistent with official orders, program guidance letters, and other information released by the FAA. Ensure any guidance added online includes clear publication dates, effective dates, or version information. This would help sponsors determine whether online guidance, tools, and related materials reflect the most recent changes in guidance. Comment ensures an airport sponsor can understand where a requirement comes from and whether the existing version of a specific document is current. Preamble Page i-vi-i-vii Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Include Additional Eligible Project Formulation Costs
Section 2-3.6.6.8.1 discusses the scope of project formulation costs (incurred before the grant agreement is executed) that are eligible for reimbursement. Some AAAE members urged the FAA to include additional costs as eligible. Consider including certain procurement actions as eligible project formulation costs, such as EMAS systems where only one FAA-approved vendor exists. Comment improves clarity or the application of a policy in the document. Chapter 2 Page 2-28 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Reference NPIAS and ACIP Formulation Order
Section 3-2.2.2 includes useful information regarding project phasing and overall development objectives. This topic ties closely to FAA Order 5090.5, Formulation of the NPIAS and ACIP, although there is no mention of the order in the section. Include a reference or explanation of the relationship between Section 3-2.2.2 and FAA Order 5090.5, which would help connect planning requirements with grant application guidance. Comment improves internal consistency and/or cross-references with other FAA guidance. Chapter 3 Page 3-4 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Address Outdated PERADA Checklist References
Section 3-2.3 discusses pre-grant application processes and states that an FAA field office may use FAA Form 5100-109, AIP Project Evaluation Review and Development Analysis (PERADA). This form currently contains references to FAA Order 5100.38D and will be outdated if not updated when the final Order 5100.38E is published. Ensure that FAA Form 5100-109 is updated at the time of publishing FAA Order 5100.38E. Comment ensures an airport sponsor can understand where a requirement comes from and whether the existing version of a specific document is current. Chapter 3 Page 3-5 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Clarify Acquisition of Good Title Language
Section 3-3.1.1 states that for the FAA "[t]o issue a grant where good title to the airport operating areas (AOA) is not yet in place, but is being acquired, FAA policy requires that the acquisition of good title must be in process." Several AAAE members wanted more clarification about what "in process" means and how an airport sponsor would manage the Exhibit A requirement in these circumstances. Provide more guidance on when the acquisition of good title is considered to be "in process" and how an airport sponsor would fulfill the Exhibit A requirement in these circumstances. Comment identifies an ambiguous or incomplete instruction or directive to FAA field offices. Chapter 3 Page 3-5 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Correct Cross-Reference to Appendix K
Section 3-3.1.3.1 directs users to Appendix K for additional information on consultation with airport users as part of a planning effort. However, Appendix K does not appear to mention consultations. Confirm or correct that the cross-reference to Appendix K is accurate. Comment improves internal consistency and/or cross-references with other FAA guidance. Chapter 3 Page 3-6-3-7 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Discuss EO 12372 in Intergovernmental Review Section
Section 3-3.1.3.2 discusses an airport sponsor's intergovernmental review requirements for federally funded projects. However, there is no discussion on Executive Order 12372 despite multiple references to the order and requirement in the intergovernmental/state review section of FAA's grant application (SF-424). Provide an overview and discussion of Executive Order 12372 to ensure airport sponsors submitting an FAA grant application better understand those requirements. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Page 3-7 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Consider More Precise Topic Header
The header for Section 3-3.2, "Compliance Prerequisites," may be broader than the content indicates. Consider changing the header to "Grant Assurance Compliance Prerequisites," which seems to more accurately describe the section focused on grant assurance compliance. Comment improves a name, definition, or term to ensure clarity for airport sponsors. Chapter 3 Page 3-7 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Address BABA with Buy America Requirements
Section 3-3.2.2 discusses Buy America requirements under 49 U.S.C. Sec. 50101 but does not reference Build America, Buy America (BABA) requirements. FAA guidance indicates BABA applies to AIP-funded projects and expands domestic preference requirements beyond traditional Buy America, particularly for construction materials. Clarify how airport sponsors should understand both requirements (BABA and Buy America) together. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Page 3-7-3-8 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Discuss DOT Waiver of Buy America Requirements for De Minimis Costs and Small Grants
Neither Section 3-3.2.2, which covers Buy America requirements, nor the FAA's website (which is linked to in the Draft AIP Handbook) discusses DOT's August 16, 2023 "Waiver of Buy America Requirements for De Minimis Costs and Small Grants" (88 Fed. Reg. 55817). Clarify how airport sponsors and their contractors may utilize the DOT waiver of BABA requirements for de minimis costs and small grants, which the department issued in August 2023. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Page 3-7-3-8 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Align Wording in Section on Exceeding FAA Standards
Section 3-3.2.4.3 discusses when an FAA field office may fund a project that exceeds FAA standards. The second paragraph states: "Proactive improvements to sustain operations and permit resumption of operations following natural disasters per 49 U.S.C. Sec. 47102 are also deemed justified by ARP Headquarters . . . ." This is an incorrect restatement of 49 U.S.C. Sec. 47102(3)(T). Correct the language to use "or" instead of "and" in order for the sentence to be consistent with 49 U.S.C. Sec. 47102(3)(T). Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Page 3-9 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Consider Allowing Local Building Standards for Terminal Projects
Sections 3-3.2.4.4 and 3-3.2.4.5 discuss when state standards may be used in lieu of FAA standards and notes that some eligible projects do not have FAA standards, procedures, policy, plans, or specifications. Some AAAE members urged FAA to allow and/or accept the use of local building standards for terminal projects where FAA has no standards. Consider allowing airport sponsors to use local building standards for terminal projects where FAA has no standards. Comment identifies an ambiguous or incomplete instruction or directive to FAA field offices. Chapter 3 Page 3-9-3-10 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Align DBE Threshold Requirement with Regulation
Table 3-3.1 states that an airport sponsor must have a DBE program "if it will award $250,000 in AIP funding during a Federal fiscal year." The DBE regulation uses different phrasing regarding when a sponsor must have a DBE program. Correct the language to align with 49 C.F.R. Sec. 26.21(a)(3), which states that FAA recipients must have a DBE program if they are "receiving grants for airport planning or development that will award prime contractors the cumulative total value of which exceeds $250,000 in FAA funds in a Federal fiscal year." The final Order 5100.38E should align more closely with the regulation. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Page 3-11, Table 3-3.1 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Confirm New Sponsor Review Process Applies
In the current AIP Handbook, Table 3-12(a) requires the FAA field office to inform new airport sponsors of the required intergovernmental project review process in accordance with FAA Order 1200.21. However, this requirement is not stated in the Draft AIP Handbook, and it is unclear whether it remains in effect. Clarify whether the appropriate FAA regional office or ADO must continue to notify sponsors of this process. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Not applicable Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Clarify Timing of Economic Price Adjustments Provision
Section 3-4.1.2 discusses FAA's authority in 49 U.S.C. Sec. 47108 that allows the agency to include a provision in a grant agreement under which the FAA agrees to pay more than the maximum amount otherwise specified in the agreement if commodity or labor prices have increased since the grant agreement was executed. It is unclear, however, whether this provision must be included in the original grant agreement or may be added later through an amendment. Clarify whether the economic price adjustments provision may be added to a grant agreement after it has been executed. Comment identifies an ambiguous or incomplete instruction or directive to FAA field offices. Chapter 3 Page 3-13-3-14 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
AIP Comment Import Template to AIP Handbook 5100.38E
Address Inconsistencies on Alternative Project Delivery Contracts Section
Section 3-4.2.7 discusses the circumstances under which FAA may authorize an airport sponsor to use an alternative project delivery contract method in accordance with 49 U.S.C. Sec. 47142. Section 47142 was recently amended by the FAA Reauthorization Act of 2024 and after FAA AC 150/5100-14 was last update. This has created inconsistencies between the draft AIP Handbook and FAA AC 150/5100-14. Ensure Section 3-4.2.7 explains that FAA AC 150/5100-14 does not represent the latest guidance from FAA on the use of alternative project delivery contract methods. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Page 3-17 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Clarify Language on Consultant Contract Extensions
Section 3-4.2.13.2 appears incomplete or potentially inconsistent with Section 2.7.2.4 of FAA AC 150/5100-14E. The Draft AIP Handbook seems to impose a strict prohibition on extending consultant services contracts beyond five years. However, the AC states that a project initiated in the first five years may continue beyond the initial contract duration, but no new projects should be initiated without a new procurement action. Clarify and/or address the inconsistencies between Section 3-4.2.13.2 of the Draft AIP Handbook and Section 2.7.2.4 of FAA AC 150/5100-14E. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Page 3-21 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Set Threshold When Construction Management Programs Are Required
In the current AIP Handbook, FAA only requires a construction management program (CMP) to be submitted to a field office if the project has a total pavement construction contract value over $500,000. A CMP ensures quality control and compliance with applicable construction standards. Unfortunately, the Draft AIP Handbook does not specify any threshold (above which a CMP is required), implying that all projects require a CMP. Specify that an airport sponsor must only submit a CMP if the project has a total pavement construction contract value over $1,000,000 (if not higher). We believe an adjustment for rising construction costs is appropriate because the $500,000 threshold was last established in 2014. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 4 Page 4-21 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Include DCL in Appendix A as Acronym
DCL, discretionary candidate list, is a common FAA phrase used in the Draft AIP Handbook but is not included in Appendix A. DCL should be included in Appendix A to allow readers to understand the abbreviation without relying on external knowledge. Comment improves a name, definition, or term to ensure clarity for airport sponsors. Appendix A Pages A-1-A-5 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Adjust Justification Requirement for Apron Reconstruction and Rehabilitation Projects
Table B-5.2 classifies apron projects as either rehabilitation or reconstruction based on a 30 percent area or panel replacement threshold. Projects addressing less than 30 percent of an apron are categorized as rehabilitation, whereas projects affecting 30 percent or more are classified as reconstruction. Some AAAE members expressed concern that this threshold was arbitrary and would reset the useful life for a large portion of apron pavement that may only last 10 years and not the full 20 years. Consider replacing the current 30 percent threshold with a two-thirds (66.7 percent) threshold before reclassifying a concrete panel project from rehabilitation to reconstruction. This would allow airport sponsors to replace up to 66 percent of failing apron panels under a simpler rehabilitation process, reducing bureaucratic hurdles and engineering costs. Comment improves clarity or the application of a policy in the document. Appendix B Page B-22 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Expand Eligibility of EMAS-Related Projects
Table C-3.1 outlines the justification requirements for projects to construct, reconstruct, and rehabilitate Engineered Materials Arresting Systems (EMAS). EMAS installations are critical safety infrastructure that provide a proven means of reducing the consequences of runway overruns. Some AAAE members support the current language that recognizes the eligibility of EMAS replacement when panels are destroyed by an aircraft and no other funding source, such as insurance, is available. However, like other airfield safety systems, EMAS requires periodic inspection, testing, evaluation, and rehabilitation to ensure it will perform as designed when needed. The Draft AIP Handbook does not clearly identify these activities as eligible for AIP funding. Some AAAE members urged the FAA to consider strengthening the language regarding EMAS to explicitly recognize testing, rehabilitation, and restoration activities as AIP-eligible projects. This should allow AIP funding for: (a) the testing and evaluation necessary to verify the continued operational effectiveness of an EMAS installation; (b) the rehabilitation, restoration, or repair of EMAS components that have deteriorated due to age, weather exposure, settlement, or other operational factors; (c) the restoration of EMAS systems following aircraft engagements when insurance proceeds or other funding sources are unavailable or insufficient to return the system to its original design standard; and (d) the periodic assessments necessary to determine remaining service life and identify corrective actions required to maintain operational readiness. Providing this clarification would promote consistency among FAA regions, help airport sponsors maintain critical runway safety infrastructure, and ensure EMAS systems remain fully functional throughout their service life. Comment improves clarity or the application of a policy in the document. Appendix C Pages C-7-C-8 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Relax Justification Requirements for Certain Service Road Projects
Table C-4.1 outlines justification requirements for air operations projects. For the construction, improvement, rehabilitation, and reconstruction of service roads, the FAA states that "[e]ligibility for new construction is tied to the overall development objective and should be constructed with the project requiring the need for the service road." Non-public airside service roads directly enhance capacity by keeping service vehicles off active taxiways. Tying a new service road to an eligible facility is more restrictive than operational needs. Consider new language that allows more flexibility at airports that could benefit from new service roads to eliminate service vehicles on active AOA surfaces. Comment improves clarity or the application of a policy in the document. Appendix C Pages C-16-C-17 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Clarify Stand-Alone Marking Projects
Appendix F outlines the eligibility and justification requirements for lighting, signage, and marking projects needed to support eligible aircraft operational surfaces. Table F-3.3 provides that stand-alone marking projects are not eligible at large hub airports. However, Section F-2.2.1 states that there is a general exception for stand-alone lighting, signage, and marking projects to correct a documented safety requirement, deficiency, violation, or recommendation. Clarify that the general exception explained in Section F-2.2.1 applies to large hub airports notwithstanding the exclusion identified in Table F-3.3. Comment improves clarity or the application of a policy in the document. Appendix F Page F-3 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Allow Stand-Alone Airfield Lighting Control and Monitoring System Projects in Some Cases
Table F-3.1 provides that stand-alone projects involving airfield lighting control and monitoring systems (ALCMSs) are excluded work and not eligible. This exclusion would limit the ability for airports with a robust airfield electrical replacement program from replacing these systems if their airfield electrical is in good condition. It may also prompt some airport sponsors to replace otherwise good lighting altogether with the ALMCS. Consider allowing a stand-alone ALCMS project if greater than 40 percent of the airport's lighting has been replaced in the past 10 years. Comment improves clarity or the application of a policy in the document. Appendix F Page F-7 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Define or Clarify "Level of Service"
Appendix N, which discusses eligibility and justification requirements for airport terminal projects, uses the term "level or service" (or "levels of service") in a number of occasions, but the term is ambiguous and undefined. Clarify or explain the FAA's intent with regards to "level of service" to help airport sponsors understand how it is applied in the context of eligibility and justification requirements for terminal projects. Comment improves a name, definition, or term to ensure clarity for airport sponsors. Appendix N Pages N-9, N-11, N-12 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Provide Sponsors with the FAA's Project Work Codes
In the current AIP Handbook, the FAA identified the various agency work codes associated with each type of project. Some AAAE members expressed concern that removal of the work codes from eligible project descriptions may introduce ambiguity or confusion between airport sponsors and the FAA regarding the exact scope or eligibility of projects. Provide sponsors with the overall development objective work codes associated with each project, either in the existing appendices or in a separate FAA document. Comment improves a name, definition, or term to ensure clarity for airport sponsors. Appendix B-Appendix O Not applicable Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Provide Examples for Standardized Justification Requirements
Justification requirements appear to be standardized across multiple project appendices using generic language. Some AAAE members expressed concern that the generic language and standardization makes it harder to understand the FAA's expectations regarding eligibility and justification requirements. Consider including examples to help airport sponsors understand how common projects satisfy these requirements. For example, the FAA could explain how a typical Part 150 noise mitigation project in Table I-2.1 satisfies one of the three congressionally directed priorities. Comment improves clarity of a specific policy in the document. Appendix B-Appendix O Not applicable Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Enumerate Contents in Each Table with Letter or Number
In the current AIP Handbook, each table has letters (e.g., a, b, c) for each line of the table to help with citations and references. Some AAAE members indicated that the text inside each table in the Draft AIP Handbook is often difficult to cite or reference because there are no letters or numbers. Consider enumerating lines within each table with letters to make citations more specific and improve usability during coordination between airport sponsors and FAA field offices. Comment improves internal consistency and/or cross-references with other FAA guidance. General Comment Not applicable Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Identify Sources of FAA Policy References
Several requirements throughout the Draft AIP Handbook are attributed to FAA policy ("By FAA policy" or "Per FAA policy") without identifying the underlying source of the policy. Ensure that if the Draft AIP Handbook is the source of the policy, that should be stated directly. If the policy originates in another FAA order, memorandum, or guidance document, the source should be cited. Comment ensures an airport sponsor can understand where a requirement comes from and whether the existing version of a specific document is current. General Comment Not applicable Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Clarify Definitions of Certain Types of Projects
In the current AIP Handbook, Table I-2 explains the distinction between construct, extend, widen, strengthen, and rehabilitate, and Table 3-2 explains the differences between maintenance, rehabilitation, reconstruction, and replacement projects. Table 2-2.1 in the Draft AIP Handbook provides clarity between construction, routine work, rehabilitation, and reconstruction. The draft document also uses many of these terms as project categories and unit-of-work labels but does not appear to define them. This has led to questions from AAAE members and may lead to confusion about how the FAA defines them. Definitions are important because these terms have major implications for project eligibility and the applicable amount of useful life that applies. Clarify how the FAA defines and evaluates the terms in Table 3-2 and Table I-2 from the current AIP Handbook. Comment improves a name, definition, or term to ensure clarity for airport sponsors. General Comment Not applicable Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
*
Original text of letter here: https://www.regulations.gov/comment/FAA-2026-4006-0028
August 17, 2026
William Garrison
Acting Director
Office of Airport Planning and Programming
Federal Aviation Administration
800 Independence Ave., SW
Washington, DC 20591
RE:
Federal Aviation Administration; Request for Public Comment
Notice of Draft FAA Order 5100-38E, Airport Improvement Program Handbook
Docket No. FAA-2026-4006 (May 19, 2026)
Dear Mr. Garrison:
The American Association of Airport Executives ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 17, 2026 William Garrison Acting Director Office of Airport Planning and Programming Federal Aviation Administration 800 Independence Ave., SW Washington, DC 20591 RE: Federal Aviation Administration; Request for Public Comment Notice of Draft FAA Order 5100-38E, Airport Improvement Program Handbook Docket No. FAA-2026-4006 (May 19, 2026) Dear Mr. Garrison: The American Association of Airport Executives(AAAE), which represents over 12,000 members serving nearly 875 airports across the country, appreciates the opportunity to provide feedback in response to the Federal Aviation Administration's (FAA) request for public comment on draft FAA Order 5100.38E, "Airport Improvement Program Handbook" ("Draft AIP Handbook"), which is the primary guide for the FAA's funding of airport development projects under the Airport Improvement Program (AIP).1 The AIP is a critical funding program for airport sponsors to implement their capital programs, especially critical safety-enhancing airfield projects, and we are pleased to share our unique perspective on the proposed AIP Handbook update.
Introduction and Summary of Recommendations
We generally support the FAA's stated objectives with the Draft AIP Handbook, which include clarifying statutory requirements, eliminating redundancies, creating an easily updated structure, increasing opportunities for efficiency, and delegating more decision-making to FAA field offices.2 However, AAAE members expressed several concerns. First, despite countless hours reviewing the draft document, the lack of any change summary from the FAA made it difficult to understand the scope and nature of the changes and whether the document fulfills the FAA's stated objectives. Second, while we support delegating decision-making to FAA field offices, we are concerned that the recent reduction in FAA staffing may lead to slower review times and further delays than what airport sponsors already experience. Third, although we appreciate the FAA adopting several efficiency improvements, AAAE believes additional changes are needed to streamline the grantmaking process.1 Notice of Draft FAA Order 5100-38E, Airport Improvement Program Handbook, 91 Fed. Reg. 29247 (May 19, 2026) (request for public comment).2 Fed. Aviation Admin., Airport Improvement Program Handbook i-i (2026) (hereinafter "Draft AIP Handbook").
From AAAE's understanding of the proposed changes, we believe that the FAA should take the following actions to simplify certain AIP processes, improve the usability of the document, and ensure its stated objectives are accomplished:
The FAA should (a) provide a summary of changes made in the Draft AIP Handbook and an opportunity to comment on the changes and (b) educate airport sponsors on specific changes that the FAA adopts in the final document.
The FAA should eliminate or relax its requirement that airport sponsors demonstrate an "actual need" or justification for each proposed project before an AIP entitlement grant may be awarded. At the very least, the FAA should simplify determinations that certain types of projects have the necessary justification and an actual need.
The FAA should (a) limit the authority of field offices to require a benefit-cost analysis (BCA) for "any" project and (b) increase the threshold that determines when a BCA is required for a project.
The FAA should provide increased flexibility, discretion, and decision-making authority to FAA field offices to accelerate reviews, and airport sponsors must be given an appeal option in case that discretion is abused or applied inconsistently.
The FAA must ensure adequate staffing levels in its field offices commensurate with increased responsibilities so that the handbook's objectives are achieved.
The FAA should adopt the proposal to allow self-certification of eligible costs for terminal projects without limiting this self-certification option to projects that use $10 million or less in passenger facility charge (PFC) revenue.
The FAA should eliminate the new justification requirement that only allows AIP funding for reconstruction or rehabilitation of a primary runway if the runway is within 120 percent of the runway length needed by the airport's "critical aircraft" (unless a specific exception applies).
The FAA should eliminate the new noise exposure map (NEM) annual certification requirement as a condition of receiving a grant for a noise mitigation project and address other questions regarding required documentation to obtain a grant for these projects.
The FAA should (a) set deadlines for its field offices to complete the various reviews associated with AIP grants and (b) provide the expected review duration for each type of approval.
In addition to the recommendations provided in this letter, AAAE developed and provided dozens of other specific comments to the Draft AIP Handbook. Attached is an Excel spreadsheet with those comments, which are more detailed and intended to, among other things, identify ambiguous instructions to FAA field offices; identify conflicts between the draft document and statutes and other FAA guidance documents; improve the clarity and application of specific policies; and ensure airport sponsors understand various FAA requirements associated with securing AIP grants. Aside from our comments, we urge the FAA to continue to engage and communicate with AAAE and the industry as the agency transitions to Order 5100.38E. This will be important as airport sponsors need education on the updated handbook to ensure they understand the processes and requirements for access to critical AIP funding.
AAAE's Recommendations for FAA
Summary of AIP Handbook Changes
1. The FAA should (a) provide a summary of changes made in the Draft AIP Handbook and an opportunity to comment on the changes and (b) educate airport sponsors on specific changes that the FAA adopts in the final document.
One of the major concerns that AAAE heard from its members was the lack of any summary of changes between the current AIP Handbook (Order 5100.38D) and the Draft AIP Handbook (Order 5100.38E). On its website, the FAA has listed a "Draft Order 5100.38E, AIP Handbook: Key Updates (coming soon)" marker since the draft document was released in May.3 To date, the FAA has not posted any comparison of the two handbooks on its website despite the significance of the changes made. There are also no redlines included in the Draft AIP Handbook even though it is a complete rewrite and has 274 fewer pages than the version released in 2019. Overall, it has been very challenging for AAAE and the airport community to understand what changes have been made in the document, especially from a policy perspective. In light of these concerns, AAAE urges the FAA to release a summary of changes to the current AIP Handbook as soon as possible and offer another opportunity to comment on the changes that have been made. This could be in the form of a crosswalk document that details changes between current order and the draft document (similar to the Excel spreadsheet that was provided to industry when Change 1 to Order 5100.38D was released). The summary is necessary to help airport sponsors understand the Draft AIP Handbook, including changes incorporated from program guidance letters (PGLs) and other updated FAA documents. In addition, we highly encourage the FAA to engage with industry, through conferences and other forms of outreach, to answer questions and educate the community on the changes to ensure a successful transition to Order 5100.38E.
3. Fed. Aviation Admin., Draft AIP Handbook, Order 5100.38E (May 22, 2026), https://www.faa.gov/airports/aip/aip_handbook/draft.
Mr. William Garrison
August 17, 2026 | Page 4 of 12
Project Justification and Actual Need Requirements
2. The FAA should eliminate or relax its requirement that airport sponsors demonstrate an "actual need" or justification for each proposed project before an AIP entitlement grant may be awarded.
AAAE strongly disagrees with the FAA's position that an airport sponsor must demonstrate a justification and "actual need" to use AIP entitlement funds for an eligible project. In explaining its grant authority in the Draft AIP Handbook, FAA states that "if the FAA determines that a project is eligible and justified at that airport, then the FAA may fund the proposed project in whole or in part."4 For each proposed project, the justification test requires an FAA field office to ensure (a) the project advances an AIP policy; (b) an actual need for the project exists; and (c) the project scope is appropriate.5 FAA explains the test is a needs-based determination delegated to the agency by 49 U.S.C. Sec. 47103, which requires the development of the biennial National Plan of Integrated Airport Systems (NPIAS), and Sec. 47104, which grants the FAA the general authority to issue AIP grants "[t]o maintain a safe and efficient nationwide system of public-use airports that meets the present and future needs of civil aeronautics." Both the statutory framework and its legislative history confirm that Congress never intended to require airport sponsors to demonstrate project justification before receiving AIP entitlement funds. First, Congress did not require an airport sponsor to demonstrate an actual need in the statutes governing the issuance of grants. Under Sec. 47105, Congress allows a sponsor to apply for a grant if the sponsor (a) proposes a project for an airport identified in the NPIAS; (b) submits a proposed project description; (c) proposes an eligible "airport development" project, as defined in 49 U.S.C. Sec. 47102(3); (d) proposes a project that complies with any applicable FAA technical standards, such as airport lighting guidance; and (e) provides other information requested by the FAA.6 Section 47106 outlines the factors the FAA must consider when evaluating the application. While one of the criteria is for the FAA to ensure the project "contribute[s] to carrying out this subchapter," Congress has outlined its policies and priorities for AIP, which are extremely broad, such as improving airport safety, security, and capacity; protecting the environment; and minimizing noise impacts; among other things.7 Second, under the statute, there are only two extremely nuanced cases where FAA must apply a "justification" or "airside needs test" requirement for a proposed project.8 The omission of these requirements-from the specific grant application requirements in Sec. 47105, grant approval conditions in Sec. 47106, and other provisions in Title 49 of the U.S. Code-demonstrates that Congress's intent is to not require the FAA to determine whether an airport sponsor has an actual need or justification for a proposed project more generally. Third, while we recognize the FAA's need to understand the justification for a project before awarding a discretionary grant, this same rationale does not apply to entitlement grants. Under Sec. 47114, which governs apportionments (also known as entitlements), Congress provided that the Secretary of Transportation "shall" apportion funds to specific airports on an annual basis. If the project is eligible, and the airport sponsor has the statutory right to the funds, we do not believe it is appropriate for the FAA to impose a justification requirement that is not in the statute and that Congress never intended to apply. Moreover, Congress directed the FAA to "discourage" a sponsor from using entitlement funds for "lower priority projects by giving lower priority to discretionary projects" submitted by the sponsor (which has used its entitlement funds for such a low-priority project).9 This provision presupposes that airport sponsors were given the discretion to decide the most appropriate use for their entitlement funds, albeit with potential impacts on its discretionary fund requests. Fourth, the FAA's reliance on the NPIAS report requirement as the basis for the justification test and needs-based determination is misguided. Section 47103(a) provides that the NPIAS must "include the kind and estimated cost of eligible airport development the [FAA] considers necessary to provide a safe, efficient, and integrated system of public-use airports adequate to anticipate and meet the needs of civil aeronautics." The purpose of the NPIAS is not to limit the projects for which an airport sponsor may use AIP funding. A plain reading of Title 49 of the U.S. Code indicates that the NPIAS is used to help Congress budget and evaluate the full scope of infrastructure needs across the system, by FAA for planning purposes to promote the development of an integrated airport system,10 to determine the airports that are eligible to receive a grant,11 to limit the projects that may be funded by airports designated in the unclassified status,12 and to determine the annual apportionment amount for each non-commercial service airport.13 Moreover, nothing in the legislative history of the NPIAS requirement suggests it was designed to impose additional hurdles for an airport sponsor to obtain a grant for eligible projects. In 1982, Congress began requiring the FAA to develop the NPIAS, replacing the former National Airport System Plan (NASP).14 The major shift from the NASP to the NPIAS was for FAA to focus on "integrated airport systems." This was a major congressional policy priority at the time because of the need to develop and improve reliever airports to alleviate traffic congestion at major airport hubs and increase capacity in metropolitan areas.15 Indeed, Congress also directed FAA to fund grants for, and prioritize projects that are consistent with, "integrated airport system planning," which the law defined to mean "developing for planning purposes information and guidance to decide the extent, kind, location, and timing of airport development needed in a specific area to establish a viable, balanced, and integrated system of public-use airports."16 In short, the NPIAS was created to establish the scope of airports (existing and new) that are needed for an "integrated airport system" and eligible for grants and to provide information and guidance to a range of stakeholders for planning purposes. Separate from the statutory framework, we believe, as a matter of policy, that FAA staff should give substantial deference to the judgment of airport sponsors on the appropriateness of a proposed project. Airport sponsors are public in nature with a public mission and unique knowledge of the needs and requirements of the facilities for which they are responsible. They have decades of experience in successfully utilizing federal grant dollars for worthy projects that enhance safety and meet the other objectives specified by Congress and the agency. Sponsors report to AAAE incurring significant costs to justify and explain to the FAA why the project is needed and why the sponsor should be allowed to use funds that it is entitled to under the law. We do not believe this is an efficient use of limited resources, and sponsors need more flexibility in order to maintain and grow their facilities safely and efficiently. In addition, with the FAA experiencing a significant decrease in its staffing, we believe the agency has a unique opportunity to adapt and adjust its procedures to make the existing workload on staff more manageable. Thus, we urge the FAA to eliminate or relax its requirement that sponsors demonstrate an actual need or justification for each proposed project before an AIP entitlement grant may be awarded.
3. At the very least, the FAA should simplify determinations that certain types of projects have the necessary justification and an actual need.
AAAE disagrees with the FAA's position that an airport sponsor must demonstrate an actual need for a proposed project in order to use AIP entitlement funds, including any argument that Sec. 47103 requires such a determination. Notwithstanding, the FAA has discretion to instruct and simplify the process for FAA field offices to determine what constitutes an actual need for a proposed project to meet the criteria. Indeed, nothing in Title 49 of the U.S. Code defines how the FAA is expected to determine, for purposes of the NPIAS, what types of airport development projects are "necessary to provide a safe, efficient, and integrated system of public-use airports adequate to anticipate and meet the needs of civil aeronautics . . . ."17
17. 49 U.S.C. Sec. 47103(a).
Mr. William Garrison
August 17, 2026 | Page 7 of 12
AAAE urges the FAA to exercise its discretion and simplify the process for an FAA field office to make a determination that certain types of proposed projects have an actual need, including projects (a) that would be funded through an AIP entitlement grant or (b) where the federal share would be less than a specified threshold (e.g., 50 percent). If an airport sponsor is funding the majority of costs for a specific project, the FAA should presume there is an "actual need" for that project and the federal funds are not being used on a frivolous project. In such a case, a need-based determination is unnecessary, and the agency could simply presume projects falling into a certain category are necessary for meeting the needs of civil aeronautics.
4. The FAA should (a) limit the authority of field offices to require a BCA for "any" project and (b) increase the threshold that determines when a BCA is required for a project.
Under Sec. 47115(d), Congress only requires that the FAA consider a BCA before issuing a grant if (a) the project to be funded is for preserving and improving capacity and (b) the FAA is planning to use funds from its discretionary fund. No other types of projects receiving discretionary funds are required to undergo a BCA review.18 In the Draft AIP Handbook, the FAA provides that sponsors must prepare a BCA for capacity projects if it is requesting an amount of discretionary funding that exceeds a certain threshold. However, the FAA does not disclose the current threshold above which a sponsor must prepare a BCA for a project seeking discretionary funding.19 Separately, the FAA states that the agency "may" require a BCA for any other AIP project.20
We have two major concerns regarding the provisions on BCAs. First, if FAA field offices were given the authority to require a BCA for any project, regardless of funding amount, it would introduce new risks for an airport sponsor to execute a project in a reasonable timeframe. Any office could arbitrarily decide at any time that a project requires a BCA, even if the project has been in development for years and despite representations from staff that a BCA would not be required. This type of scenario could greatly extend a project's timeline. Second, ironically, many AAAE members expressed frustration with the high costs associated with preparing a BCA relative to its overall benefits in the case of most projects.
AAAE urges the FAA to make two changes to the directives on BCAs. First, the FAA should only require a BCA for projects for which Congress has directed the agency to evaluate the benefits and costs. This would only include capacity-enhancing projects receiving AIP discretionary funds. For all other projects, a BCA should remain optional supplemental information that an airport sponsor may provide if the sponsor believes it would help make the case to the FAA for a discretionary funding request. At the very least, the FAA should establish strict parameters for field offices when they may require a BCA to limit the overly broad discretion given to FAA field offices in the Draft AIP Handbook. Second, the FAA should increase the funding threshold that determines whether a BCA is required and index it for inflation.
18. See id. Sec. 47115(d)(2).19. Draft AIP Handbook, supra, at 2-10.20. Id. at 2-11.
Mr. William Garrison
August 17, 2026 | Page 8 of 12
FAA Field Office Authority
5. The FAA should provide increased flexibility, discretion, and decision-making authority to FAA field offices to accelerate reviews, and airport sponsors must be given an appeal option in case that discretion is abused or applied inconsistently.
As explained by the FAA in the preamble, one of the agency's stated objectives with the Draft AIP Handbook was to shift more decision-making and approvals to FAA field offices. AAAE is generally supportive of delegating increased authority to these offices, which would help accelerate reviews and approvals for airport sponsors. However, many AAAE members are concerned about the potential for abuse of that discretion or inconsistent application of the AIP across regions. An example is a case where one office approves a project grant while another office does not, despite factual circumstances being similar. Moreover, sponsors routinely report to AAAE that they are hesitant to elevate issues or concerns with decisions made by FAA field offices because of fear of retribution. Thus, we urge the FAA to establish and outline a procedure in the final handbook that allows sponsors to request further review from headquarters staff, without retribution or penalty, to ensure AIP policies and rules are consistently applied and in accordance with the intent of the agency.
6. The FAA must ensure adequate staffing levels in its field offices commensurate with increased responsibilities so that the handbook's objectives are achieved.
In 2025, the FAA experienced a significant reduction in staffing through deferred resignations, early retirements, and other initiatives. While safety-critical staff were exempt from the reductions, the agency reportedly lost a significant number of program managers, environmental protection specialists, and airport planners, among others, in the Office of Airports. These personnel are essential to facilitating the approvals required for sponsors to secure AIP grants, which provide vital funding for critical airport safety projects. Indeed, AAAE has received reports from its members that staffing issues at FAA have already led to delays with obtaining grant-related approvals. AAAE is concerned that the staffing reductions in FAA field offices, along with the increased decision-making authority, may lead to further delays in obtaining the necessary approvals. Therefore, we strongly urge the FAA to ensure that the agency has adequate local staff that is commensurate with their increased responsibilities.
Project-Specific Comments
7. The FAA should adopt the proposal to allow self-certification of eligible costs for terminal projects without limiting this self-certification option to projects that use $10 million or less in PFC revenue.
Under the Draft AIP Handbook, Appendix N outlines the eligibility and justification requirements for terminal development projects. These generally include projects within the terminal building and associated with the airside and landside areas that are directly related to the movement of passengers and baggage. Terminal projects typically have a mix of eligible and ineligible areas that require prorating the total project cost to properly allocate funding. (Costs are generally prorated using the ratio of eligible area to total area.) One notable change in the draft handbook is to streamline the process for determining allowable costs for terminal projects with both eligible and ineligible areas. Under the proposal, the FAA would allow airport sponsors (rather than FAA staff) to calculate and self-certify eligible costs if the sponsor is requesting that the FAA cover no more than 70 percent of the project's eligible costs.21
AAAE strongly supports the proposal to allow airport sponsors to self-certify eligible costs but urges the FAA to make one change. In Section N-2.2.1 of Appendix N, the FAA states that the self-certification option "may not be available" for airports that anticipate using more than $10 million in PFC funds for the project because they "are required to provide detailed basis of cost information."22 We believe this exception to the self-certification option should be eliminated. The $10 million cap would severely limit the availability of this option and would effectively prevent many larger airports from taking advantage of the expedited process. We do not believe the exception is necessary, and it is also unclear why the FAA established an arbitrary cap at $10 million. At the very least, the cap should be raised to $100 million (or $25 million to be consistent with the FAA's streamlined procedures for PFC authorizations).23
8. The FAA should eliminate the new justification requirement regarding primary runway reconstruction and rehabilitation projects (i.e., the 120-percent threshold).
Under the Draft AIP Handbook, Appendix B outlines the eligibility and justification requirements for projects associated with aircraft operational surfaces (AOS), including runways, taxiways, aprons, and taxilanes, among others. The draft document introduces a new justification requirement for runway reconstruction and rehabilitation projects that is not in the current AIP Handbook. Specifically, the FAA provides that full reconstruction or rehabilitation of a primary runway may only be conducted at its existing length if the runway is within 120 percent of the runway length needed by the airport's "critical aircraft," unless an exception applies.24 It is unclear why FAA added this 120-percent threshold, the rationale behind the policy change, and the intended application (including how it would apply to runways with existing dimensions that exceed current design needs). The provision also appears to focus only on runway length and does not address runway width. The consensus from AAAE members is that this new limitation is unnecessary and arbitrary and should be removed from the final handbook.
21. Draft AIP Handbook, supra, at N-10.22. Id.23. See Fed. Aviation Admin., PFC Update, PFC 73-20 (Jan. 22, 2020).24. Draft AIP Handbook, supra, at B-14.
Mr. William Garrison
August 17, 2026 | Page 10 of 12
9. The FAA should eliminate the new NEM annual certification requirement as a condition of receiving a grant for a noise mitigation project and address other questions regarding required documentation to obtain a grant for these projects.
Under the Draft AIP Handbook, Appendix I outlines the eligibility and justification requirements for airport noise compatibility programs under 14 C.F.R. pt. 150 and mitigation measures in an FAA environmental decision document for certain development projects. Table I-2.2 outlines "other considerations" for the FAA to fund a noise mitigation-related project. AAAE received many comments, concerns, and questions regarding the item, "Documentation is Current at Time of Each Funding Request," which discusses documentation from the airport sponsor that must be current to receive a noise mitigation project grant under AIP. The table states, in part:
"All documents for the implementation of remedial noise mitigation and noise abatement measures must be current at the time of each grant request. This includes [noise exposure maps (NEMs)]. In each year following the date of the FAA-accepted future NEM, sponsors must certify that the NEMs on file with the FAA accurately reflect current and projected operational conditions at the airport, sound insulation program implementation plans and acoustic test plans, and noise land inventory and reuse plans.
All maps that are five or more years old require written validation, which means the sponsor needs to explain why the accepted NEMs reflect the current or projected operational conditions at the airport for the associated noncompatible land uses. . . ." We have several concerns and questions regarding the item in Table I-2.2 on current documentation at the time of a funding request.
First, AAAE opposes the annual certification requirement regarding NEMs. The provision is not included in the current AIP Handbook, and the FAA has offered no explanation as to why an annual NEM certification is necessary or how this requirement differs from existing obligations. Indeed, Part 150 already requires airport sponsors to promptly prepare and submit a revised NEM to the FAA under certain conditions, including if a change in the operation of the airport creates a significant reduction in noise over existing noncompatible uses.25 We do not believe the certification requirement is necessary or appropriate and urge the FAA to remove it from the final handbook.
Second, we urge the FAA to clarify what specific documents must be current at the time of each grant request. Table I-2.2 states, "All documents for the implementation of remedial noise mitigation and noise abatement measures must be current at the time of each grant request. This includes NEMs." However, the FAA does not identify or discuss any other documents (besides NEMs) that need to be current. To prevent confusion, we recommend the FAA limit the applicability of the discussion to NEMs, unless the agency intended to discuss other documents that need to be current.
Third, we believe the FAA should update Table I-2.2 to provide a more comprehensive description of documentation that is required for an airport sponsor to receive a noise mitigation project grant under AIP. Sponsors should be provided with a reasonable understanding of the types of information that may be required during the grant application process. Sponsors have increasingly been asked to provide supplemental documentation that is not clearly identified in the current AIP Handbook or other existing guidance, such as information regarding specific neighborhoods proposed for testing or treatment within a noise contour. Clear handbook guidance would improve transparency, reduce uncertainty during project development, and promote more efficient grant processing.
Fourth, we believe the FAA should clarify the requirement that any NEM that is five or more years old requires "written validation" from the airport sponsor. Part 150 requires that NEMs be based "on forecast aircraft operations at the airport for a forecast period that is at least 5 years in the future."26 For a sponsor that developed an NEM with a forecast period greater than five years, it is unclear whether the validation requirement applies. We believe validation should only be required when a sponsor intends to use the NEM beyond the initial forecast period rather than an arbitrary fixed time (i.e., NEMs that are "five or more years old"). In addition, we believe the FAA should provide an estimated review timeline for this validation.
Deadlines and Expected FAA Review Timeframe
10. The FAA should (a) set deadlines for its field offices to complete the various reviews associated with AIP grants and (b) provide the expected review duration for each type of approval.
The FAA should implement deadlines for its staff to complete the various reviews associated with AIP grants and provide industry with an expected timeframe for field offices to complete those reviews. Before airport sponsors may receive an AIP grant, they must receive numerous approvals (or, in some cases, an FAA acceptance) associated with certain documents, including, but not limited to, airport layout plan (ALP) updates, aeronautical studies, aviation activity forecasts, airspace analyses, environmental analyses, modifications of standards, reimbursable agreements, construction safety and phasing plans (CSPPs), civil rights requirements, procurement processes, alternative project delivery contracts (if applicable), and grant applications. Unfortunately, FAA has never established deadlines for its staff or communicated expected review times to airport sponsors.
Under the current framework, the unpredictability of review timelines creates a bottleneck that stalls infrastructure projects, leaving airport sponsors unable to efficiently plan budgets, secure matching local funds, or begin projects during optimal construction seasons. Introducing deadlines and expected review times in the Draft AIP Handbook for each type of approval would lead to more accountability within FAA field offices, improve consistency of decision-making nationwide, enable sponsors to better plan and budget for their capital projects, and ensure that federal funds are deployed rapidly. Indeed, more transparent and predictable review process would allow airport sponsors to accelerate the delivery of critical-safety projects, expand capacity, and improve operational efficiency by reducing administrative delays.
* * *
AAAE appreciates the opportunity to provide comments on the Draft AIP Handbook. Please do not hesitate to reach out if you have any questions or require any additional information. I can be reached at justin.barkowski@aaae.org or at (703) 824-0504.
Sincerely,
Justin T. Barkowski
Legislative and Regulatory Counsel
Enclosure
Ensure Web Tools Remain Current
FAA discusses moving broadly applicable information about the AIP to the FAA's website. In addition, the FAA mentions an AIP funding tool that will also be on the website at the time of final publication. While AAAE is supportive of this approach and tool, we want to make sure the information online stays current and consistent with official orders, program guidance letters, and other information released by the FAA. Ensure any guidance added online includes clear publication dates, effective dates, or version information. This would help sponsors determine whether online guidance, tools, and related materials reflect the most recent changes in guidance. Comment ensures an airport sponsor can understand where a requirement comes from and whether the existing version of a specific document is current. Preamble Page i-vi-i-vii Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Include Additional Eligible Project Formulation Costs
Section 2-3.6.6.8.1 discusses the scope of project formulation costs (incurred before the grant agreement is executed) that are eligible for reimbursement. Some AAAE members urged the FAA to include additional costs as eligible. Consider including certain procurement actions as eligible project formulation costs, such as EMAS systems where only one FAA-approved vendor exists. Comment improves clarity or the application of a policy in the document. Chapter 2 Page 2-28 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Reference NPIAS and ACIP Formulation Order
Section 3-2.2.2 includes useful information regarding project phasing and overall development objectives. This topic ties closely to FAA Order 5090.5, Formulation of the NPIAS and ACIP, although there is no mention of the order in the section. Include a reference or explanation of the relationship between Section 3-2.2.2 and FAA Order 5090.5, which would help connect planning requirements with grant application guidance. Comment improves internal consistency and/or cross-references with other FAA guidance. Chapter 3 Page 3-4 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Address Outdated PERADA Checklist References
Section 3-2.3 discusses pre-grant application processes and states that an FAA field office may use FAA Form 5100-109, AIP Project Evaluation Review and Development Analysis (PERADA). This form currently contains references to FAA Order 5100.38D and will be outdated if not updated when the final Order 5100.38E is published. Ensure that FAA Form 5100-109 is updated at the time of publishing FAA Order 5100.38E. Comment ensures an airport sponsor can understand where a requirement comes from and whether the existing version of a specific document is current. Chapter 3 Page 3-5 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Clarify Acquisition of Good Title Language
Section 3-3.1.1 states that for the FAA "[t]o issue a grant where good title to the airport operating areas (AOA) is not yet in place, but is being acquired, FAA policy requires that the acquisition of good title must be in process." Several AAAE members wanted more clarification about what "in process" means and how an airport sponsor would manage the Exhibit A requirement in these circumstances. Provide more guidance on when the acquisition of good title is considered to be "in process" and how an airport sponsor would fulfill the Exhibit A requirement in these circumstances. Comment identifies an ambiguous or incomplete instruction or directive to FAA field offices. Chapter 3 Page 3-5 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Correct Cross-Reference to Appendix K
Section 3-3.1.3.1 directs users to Appendix K for additional information on consultation with airport users as part of a planning effort. However, Appendix K does not appear to mention consultations. Confirm or correct that the cross-reference to Appendix K is accurate. Comment improves internal consistency and/or cross-references with other FAA guidance. Chapter 3 Page 3-6-3-7 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Discuss EO 12372 in Intergovernmental Review Section
Section 3-3.1.3.2 discusses an airport sponsor's intergovernmental review requirements for federally funded projects. However, there is no discussion on Executive Order 12372 despite multiple references to the order and requirement in the intergovernmental/state review section of FAA's grant application (SF-424). Provide an overview and discussion of Executive Order 12372 to ensure airport sponsors submitting an FAA grant application better understand those requirements. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Page 3-7 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Consider More Precise Topic Header
The header for Section 3-3.2, "Compliance Prerequisites," may be broader than the content indicates. Consider changing the header to "Grant Assurance Compliance Prerequisites," which seems to more accurately describe the section focused on grant assurance compliance. Comment improves a name, definition, or term to ensure clarity for airport sponsors. Chapter 3 Page 3-7 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Address BABA with Buy America Requirements
Section 3-3.2.2 discusses Buy America requirements under 49 U.S.C. Sec. 50101 but does not reference Build America, Buy America (BABA) requirements. FAA guidance indicates BABA applies to AIP-funded projects and expands domestic preference requirements beyond traditional Buy America, particularly for construction materials. Clarify how airport sponsors should understand both requirements (BABA and Buy America) together. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Page 3-7-3-8 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Discuss DOT Waiver of Buy America Requirements for De Minimis Costs and Small Grants
Neither Section 3-3.2.2, which covers Buy America requirements, nor the FAA's website (which is linked to in the Draft AIP Handbook) discusses DOT's August 16, 2023 "Waiver of Buy America Requirements for De Minimis Costs and Small Grants" (88 Fed. Reg. 55817). Clarify how airport sponsors and their contractors may utilize the DOT waiver of BABA requirements for de minimis costs and small grants, which the department issued in August 2023. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Page 3-7-3-8 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Align Wording in Section on Exceeding FAA Standards
Section 3-3.2.4.3 discusses when an FAA field office may fund a project that exceeds FAA standards. The second paragraph states: "Proactive improvements to sustain operations and permit resumption of operations following natural disasters per 49 U.S.C. Sec. 47102 are also deemed justified by ARP Headquarters . . . ." This is an incorrect restatement of 49 U.S.C. Sec. 47102(3)(T). Correct the language to use "or" instead of "and" in order for the sentence to be consistent with 49 U.S.C. Sec. 47102(3)(T). Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Page 3-9 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Consider Allowing Local Building Standards for Terminal Projects
Sections 3-3.2.4.4 and 3-3.2.4.5 discuss when state standards may be used in lieu of FAA standards and notes that some eligible projects do not have FAA standards, procedures, policy, plans, or specifications. Some AAAE members urged FAA to allow and/or accept the use of local building standards for terminal projects where FAA has no standards. Consider allowing airport sponsors to use local building standards for terminal projects where FAA has no standards. Comment identifies an ambiguous or incomplete instruction or directive to FAA field offices. Chapter 3 Page 3-9-3-10 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Align DBE Threshold Requirement with Regulation
Table 3-3.1 states that an airport sponsor must have a DBE program "if it will award $250,000 in AIP funding during a Federal fiscal year." The DBE regulation uses different phrasing regarding when a sponsor must have a DBE program. Correct the language to align with 49 C.F.R. Sec. 26.21(a)(3), which states that FAA recipients must have a DBE program if they are "receiving grants for airport planning or development that will award prime contractors the cumulative total value of which exceeds $250,000 in FAA funds in a Federal fiscal year." The final Order 5100.38E should align more closely with the regulation. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Page 3-11, Table 3-3.1 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Confirm New Sponsor Review Process Applies
In the current AIP Handbook, Table 3-12(a) requires the FAA field office to inform new airport sponsors of the required intergovernmental project review process in accordance with FAA Order 1200.21. However, this requirement is not stated in the Draft AIP Handbook, and it is unclear whether it remains in effect. Clarify whether the appropriate FAA regional office or ADO must continue to notify sponsors of this process. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Not applicable Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Clarify Timing of Economic Price Adjustments Provision
Section 3-4.1.2 discusses FAA's authority in 49 U.S.C. Sec. 47108 that allows the agency to include a provision in a grant agreement under which the FAA agrees to pay more than the maximum amount otherwise specified in the agreement if commodity or labor prices have increased since the grant agreement was executed. It is unclear, however, whether this provision must be included in the original grant agreement or may be added later through an amendment. Clarify whether the economic price adjustments provision may be added to a grant agreement after it has been executed. Comment identifies an ambiguous or incomplete instruction or directive to FAA field offices. Chapter 3 Page 3-13-3-14 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
AIP Comment Import Template to AIP Handbook 5100.38E
Address Inconsistencies on Alternative Project Delivery Contracts Section
Section 3-4.2.7 discusses the circumstances under which FAA may authorize an airport sponsor to use an alternative project delivery contract method in accordance with 49 U.S.C. Sec. 47142. Section 47142 was recently amended by the FAA Reauthorization Act of 2024 and after FAA AC 150/5100-14 was last update. This has created inconsistencies between the draft AIP Handbook and FAA AC 150/5100-14. Ensure Section 3-4.2.7 explains that FAA AC 150/5100-14 does not represent the latest guidance from FAA on the use of alternative project delivery contract methods. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Page 3-17 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Clarify Language on Consultant Contract Extensions
Section 3-4.2.13.2 appears incomplete or potentially inconsistent with Section 2.7.2.4 of FAA AC 150/5100-14E. The Draft AIP Handbook seems to impose a strict prohibition on extending consultant services contracts beyond five years. However, the AC states that a project initiated in the first five years may continue beyond the initial contract duration, but no new projects should be initiated without a new procurement action. Clarify and/or address the inconsistencies between Section 3-4.2.13.2 of the Draft AIP Handbook and Section 2.7.2.4 of FAA AC 150/5100-14E. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 3 Page 3-21 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Set Threshold When Construction Management Programs Are Required
In the current AIP Handbook, FAA only requires a construction management program (CMP) to be submitted to a field office if the project has a total pavement construction contract value over $500,000. A CMP ensures quality control and compliance with applicable construction standards. Unfortunately, the Draft AIP Handbook does not specify any threshold (above which a CMP is required), implying that all projects require a CMP. Specify that an airport sponsor must only submit a CMP if the project has a total pavement construction contract value over $1,000,000 (if not higher). We believe an adjustment for rising construction costs is appropriate because the $500,000 threshold was last established in 2014. Comment identifies a gap or conflict between text in the Draft AIP Handbook and a controlling external authority (statute, regulation, or other order or guidance document). Chapter 4 Page 4-21 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Include DCL in Appendix A as Acronym
DCL, discretionary candidate list, is a common FAA phrase used in the Draft AIP Handbook but is not included in Appendix A. DCL should be included in Appendix A to allow readers to understand the abbreviation without relying on external knowledge. Comment improves a name, definition, or term to ensure clarity for airport sponsors. Appendix A Pages A-1-A-5 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Adjust Justification Requirement for Apron Reconstruction and Rehabilitation Projects
Table B-5.2 classifies apron projects as either rehabilitation or reconstruction based on a 30 percent area or panel replacement threshold. Projects addressing less than 30 percent of an apron are categorized as rehabilitation, whereas projects affecting 30 percent or more are classified as reconstruction. Some AAAE members expressed concern that this threshold was arbitrary and would reset the useful life for a large portion of apron pavement that may only last 10 years and not the full 20 years. Consider replacing the current 30 percent threshold with a two-thirds (66.7 percent) threshold before reclassifying a concrete panel project from rehabilitation to reconstruction. This would allow airport sponsors to replace up to 66 percent of failing apron panels under a simpler rehabilitation process, reducing bureaucratic hurdles and engineering costs. Comment improves clarity or the application of a policy in the document. Appendix B Page B-22 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Expand Eligibility of EMAS-Related Projects
Table C-3.1 outlines the justification requirements for projects to construct, reconstruct, and rehabilitate Engineered Materials Arresting Systems (EMAS). EMAS installations are critical safety infrastructure that provide a proven means of reducing the consequences of runway overruns. Some AAAE members support the current language that recognizes the eligibility of EMAS replacement when panels are destroyed by an aircraft and no other funding source, such as insurance, is available. However, like other airfield safety systems, EMAS requires periodic inspection, testing, evaluation, and rehabilitation to ensure it will perform as designed when needed. The Draft AIP Handbook does not clearly identify these activities as eligible for AIP funding. Some AAAE members urged the FAA to consider strengthening the language regarding EMAS to explicitly recognize testing, rehabilitation, and restoration activities as AIP-eligible projects. This should allow AIP funding for: (a) the testing and evaluation necessary to verify the continued operational effectiveness of an EMAS installation; (b) the rehabilitation, restoration, or repair of EMAS components that have deteriorated due to age, weather exposure, settlement, or other operational factors; (c) the restoration of EMAS systems following aircraft engagements when insurance proceeds or other funding sources are unavailable or insufficient to return the system to its original design standard; and (d) the periodic assessments necessary to determine remaining service life and identify corrective actions required to maintain operational readiness. Providing this clarification would promote consistency among FAA regions, help airport sponsors maintain critical runway safety infrastructure, and ensure EMAS systems remain fully functional throughout their service life. Comment improves clarity or the application of a policy in the document. Appendix C Pages C-7-C-8 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Relax Justification Requirements for Certain Service Road Projects
Table C-4.1 outlines justification requirements for air operations projects. For the construction, improvement, rehabilitation, and reconstruction of service roads, the FAA states that "[e]ligibility for new construction is tied to the overall development objective and should be constructed with the project requiring the need for the service road." Non-public airside service roads directly enhance capacity by keeping service vehicles off active taxiways. Tying a new service road to an eligible facility is more restrictive than operational needs. Consider new language that allows more flexibility at airports that could benefit from new service roads to eliminate service vehicles on active AOA surfaces. Comment improves clarity or the application of a policy in the document. Appendix C Pages C-16-C-17 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Clarify Stand-Alone Marking Projects
Appendix F outlines the eligibility and justification requirements for lighting, signage, and marking projects needed to support eligible aircraft operational surfaces. Table F-3.3 provides that stand-alone marking projects are not eligible at large hub airports. However, Section F-2.2.1 states that there is a general exception for stand-alone lighting, signage, and marking projects to correct a documented safety requirement, deficiency, violation, or recommendation. Clarify that the general exception explained in Section F-2.2.1 applies to large hub airports notwithstanding the exclusion identified in Table F-3.3. Comment improves clarity or the application of a policy in the document. Appendix F Page F-3 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Allow Stand-Alone Airfield Lighting Control and Monitoring System Projects in Some Cases
Table F-3.1 provides that stand-alone projects involving airfield lighting control and monitoring systems (ALCMSs) are excluded work and not eligible. This exclusion would limit the ability for airports with a robust airfield electrical replacement program from replacing these systems if their airfield electrical is in good condition. It may also prompt some airport sponsors to replace otherwise good lighting altogether with the ALMCS. Consider allowing a stand-alone ALCMS project if greater than 40 percent of the airport's lighting has been replaced in the past 10 years. Comment improves clarity or the application of a policy in the document. Appendix F Page F-7 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Define or Clarify "Level of Service"
Appendix N, which discusses eligibility and justification requirements for airport terminal projects, uses the term "level or service" (or "levels of service") in a number of occasions, but the term is ambiguous and undefined. Clarify or explain the FAA's intent with regards to "level of service" to help airport sponsors understand how it is applied in the context of eligibility and justification requirements for terminal projects. Comment improves a name, definition, or term to ensure clarity for airport sponsors. Appendix N Pages N-9, N-11, N-12 Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Provide Sponsors with the FAA's Project Work Codes
In the current AIP Handbook, the FAA identified the various agency work codes associated with each type of project. Some AAAE members expressed concern that removal of the work codes from eligible project descriptions may introduce ambiguity or confusion between airport sponsors and the FAA regarding the exact scope or eligibility of projects. Provide sponsors with the overall development objective work codes associated with each project, either in the existing appendices or in a separate FAA document. Comment improves a name, definition, or term to ensure clarity for airport sponsors. Appendix B-Appendix O Not applicable Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Provide Examples for Standardized Justification Requirements
Justification requirements appear to be standardized across multiple project appendices using generic language. Some AAAE members expressed concern that the generic language and standardization makes it harder to understand the FAA's expectations regarding eligibility and justification requirements. Consider including examples to help airport sponsors understand how common projects satisfy these requirements. For example, the FAA could explain how a typical Part 150 noise mitigation project in Table I-2.1 satisfies one of the three congressionally directed priorities. Comment improves clarity of a specific policy in the document. Appendix B-Appendix O Not applicable Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Enumerate Contents in Each Table with Letter or Number
In the current AIP Handbook, each table has letters (e.g., a, b, c) for each line of the table to help with citations and references. Some AAAE members indicated that the text inside each table in the Draft AIP Handbook is often difficult to cite or reference because there are no letters or numbers. Consider enumerating lines within each table with letters to make citations more specific and improve usability during coordination between airport sponsors and FAA field offices. Comment improves internal consistency and/or cross-references with other FAA guidance. General Comment Not applicable Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Identify Sources of FAA Policy References
Several requirements throughout the Draft AIP Handbook are attributed to FAA policy ("By FAA policy" or "Per FAA policy") without identifying the underlying source of the policy. Ensure that if the Draft AIP Handbook is the source of the policy, that should be stated directly. If the policy originates in another FAA order, memorandum, or guidance document, the source should be cited. Comment ensures an airport sponsor can understand where a requirement comes from and whether the existing version of a specific document is current. General Comment Not applicable Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
Clarify Definitions of Certain Types of Projects
In the current AIP Handbook, Table I-2 explains the distinction between construct, extend, widen, strengthen, and rehabilitate, and Table 3-2 explains the differences between maintenance, rehabilitation, reconstruction, and replacement projects. Table 2-2.1 in the Draft AIP Handbook provides clarity between construction, routine work, rehabilitation, and reconstruction. The draft document also uses many of these terms as project categories and unit-of-work labels but does not appear to define them. This has led to questions from AAAE members and may lead to confusion about how the FAA defines them. Definitions are important because these terms have major implications for project eligibility and the applicable amount of useful life that applies. Clarify how the FAA defines and evaluates the terms in Table 3-2 and Table I-2 from the current AIP Handbook. Comment improves a name, definition, or term to ensure clarity for airport sponsors. General Comment Not applicable Justin Barkowski American Association of Airport Executives Trade association Alexandria Virginia justin.barkowski@aaae.org
*
Original text of letter here: https://www.regulations.gov/comment/FAA-2026-4006-0028
Alzheimer's Policy Working Group Urges Modernization of Medicare Coverage to Improve Alzheimer's Treatment Access
Carter Struck
WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
August 10, 2026
VIA ELECTRONIC SUBMISSION
The Hon. Robert F. Kennedy, Jr.
Secretary
Department of Health and Human Services
RE: Request for Information on the Update to the National Plan to Address Alzheimer's Disease
Dear Secretary Kennedy,
I appreciate the opportunity to comment on the Department of Health and Human Services' Request for Information regarding the update to the National Plan to Address Alzheimer's ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 10, 2026 VIA ELECTRONIC SUBMISSION The Hon. Robert F. Kennedy, Jr. Secretary Department of Health and Human Services RE: Request for Information on the Update to the National Plan to Address Alzheimer's Disease Dear Secretary Kennedy, I appreciate the opportunity to comment on the Department of Health and Human Services' Request for Information regarding the update to the National Plan to Address Alzheimer'sDisease.
As a neurologist in rural Michigan, I have seen firsthand how barriers to timely diagnosis and treatment can prevent patients from benefiting from recent advances in Alzheimer's care. We now have blood-based biomarkers that can facilitate earlier and more accurate diagnosis, growing evidence supporting lifestyle interventions that may help slow cognitive decline, and disease-modifying therapies for appropriate patients. In my clinical practice, I am using blood biomarker testing to reduce time to diagnosis, reduce the need for more expensive diagnosis tests (amyloid PET scans), and improve outcomes as more patients are accessing disease modifying medications. The availability of blood biomarker testing for Alzheimer's disease is the key to equal access to diagnosis and treatments. However, these advances cannot improve outcomes if patients are unable to access them.
Today, one of the most significant barriers to timely Alzheimer's care is Medicare and insurance coverage policies that have not kept pace with scientific progress.
Medicare's Coverage with Evidence Development (CED) policy continues to require additional government-approved registry participation and data collection as a condition of coverage for FDA-approved Alzheimer's treatments. When Medicare - the nation's largest healthcare payer - treats FDA approval as insufficient for routine coverage, private insurers often follow its lead. Many private insurers have adopted similarly restrictive coverage policies, subjecting patients to repeated prior authorizations, coverage denials, and treatment interruptions even after physicians have determined that treatment is medically appropriate. (Blue Cross Blue Shield of Michigan. Medical Drug Policy: Leqembi (lecanemab-irmb). Policy No. 2171624. Updated April 1, 2026. https://www.bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/2171624.pdf)
The experience of one of my patients, Lori Baetz, illustrates the real-world consequences of these policies. An FDA-approved anti-amyloid therapy helped her retain independence and continue many of her daily activities. After she retired and lost her employer-sponsored insurance, Blue Cross Blue Shield of Michigan denied coverage for her treatment. Although she ultimately prevailed in a state appeal establishing that the treatment was medically necessary and consistent with the standard of care, the insurer repeatedly failed to reimburse the health system for treatment. Her experience demonstrates that scientific breakthroughs cannot improve patients' lives if coverage policies prevent them from receiving or continuing medically appropriate care.
For a progressive disease like Alzheimer's, every delay matters. While waiting for insurance approval or enduring denials, patients may progress beyond the stage at which available therapies are indicated, losing valuable time to preserve their independence and quality of life.
As HHS updates the National Plan, I encourage the Department to prioritize policies that ensure timely access to evidence-based Alzheimer's diagnostics and treatments. This includes modernizing Medicare coverage policies to keep pace with FDA-authorized innovations, reducing unnecessary administrative barriers that delay care, and promoting continuity-of-care protections so that patients who have begun treatment are not subjected to avoidable coverage disruptions.
Thank you for considering these comments and for your continued commitment to improving the lives of people living with Alzheimer's disease and their families.
Sincerely,
Cara Leahy, DO
Director of Cognitive Disorders
Memorial Healthcare Institute for Neuroscience
Alzheimer's Policy Working Group
*
Original text of letter here: https://www.regulations.gov/comment/HHS-ASPE-2026-0298-0145
August 10, 2026
VIA ELECTRONIC SUBMISSION
The Hon. Robert F. Kennedy, Jr.
Secretary
Department of Health and Human Services
RE: Request for Information on the Update to the National Plan to Address Alzheimer's Disease
Dear Secretary Kennedy,
I appreciate the opportunity to comment on the Department of Health and Human Services' Request for Information regarding the update to the National Plan to Address Alzheimer's ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 10, 2026 VIA ELECTRONIC SUBMISSION The Hon. Robert F. Kennedy, Jr. Secretary Department of Health and Human Services RE: Request for Information on the Update to the National Plan to Address Alzheimer's Disease Dear Secretary Kennedy, I appreciate the opportunity to comment on the Department of Health and Human Services' Request for Information regarding the update to the National Plan to Address Alzheimer'sDisease.
As a neurologist in rural Michigan, I have seen firsthand how barriers to timely diagnosis and treatment can prevent patients from benefiting from recent advances in Alzheimer's care. We now have blood-based biomarkers that can facilitate earlier and more accurate diagnosis, growing evidence supporting lifestyle interventions that may help slow cognitive decline, and disease-modifying therapies for appropriate patients. In my clinical practice, I am using blood biomarker testing to reduce time to diagnosis, reduce the need for more expensive diagnosis tests (amyloid PET scans), and improve outcomes as more patients are accessing disease modifying medications. The availability of blood biomarker testing for Alzheimer's disease is the key to equal access to diagnosis and treatments. However, these advances cannot improve outcomes if patients are unable to access them.
Today, one of the most significant barriers to timely Alzheimer's care is Medicare and insurance coverage policies that have not kept pace with scientific progress.
Medicare's Coverage with Evidence Development (CED) policy continues to require additional government-approved registry participation and data collection as a condition of coverage for FDA-approved Alzheimer's treatments. When Medicare - the nation's largest healthcare payer - treats FDA approval as insufficient for routine coverage, private insurers often follow its lead. Many private insurers have adopted similarly restrictive coverage policies, subjecting patients to repeated prior authorizations, coverage denials, and treatment interruptions even after physicians have determined that treatment is medically appropriate. (Blue Cross Blue Shield of Michigan. Medical Drug Policy: Leqembi (lecanemab-irmb). Policy No. 2171624. Updated April 1, 2026. https://www.bcbsm.com/amslibs/content/dam/public/mpr/mprsearch/pdf/2171624.pdf)
The experience of one of my patients, Lori Baetz, illustrates the real-world consequences of these policies. An FDA-approved anti-amyloid therapy helped her retain independence and continue many of her daily activities. After she retired and lost her employer-sponsored insurance, Blue Cross Blue Shield of Michigan denied coverage for her treatment. Although she ultimately prevailed in a state appeal establishing that the treatment was medically necessary and consistent with the standard of care, the insurer repeatedly failed to reimburse the health system for treatment. Her experience demonstrates that scientific breakthroughs cannot improve patients' lives if coverage policies prevent them from receiving or continuing medically appropriate care.
For a progressive disease like Alzheimer's, every delay matters. While waiting for insurance approval or enduring denials, patients may progress beyond the stage at which available therapies are indicated, losing valuable time to preserve their independence and quality of life.
As HHS updates the National Plan, I encourage the Department to prioritize policies that ensure timely access to evidence-based Alzheimer's diagnostics and treatments. This includes modernizing Medicare coverage policies to keep pace with FDA-authorized innovations, reducing unnecessary administrative barriers that delay care, and promoting continuity-of-care protections so that patients who have begun treatment are not subjected to avoidable coverage disruptions.
Thank you for considering these comments and for your continued commitment to improving the lives of people living with Alzheimer's disease and their families.
Sincerely,
Cara Leahy, DO
Director of Cognitive Disorders
Memorial Healthcare Institute for Neuroscience
Alzheimer's Policy Working Group
*
Original text of letter here: https://www.regulations.gov/comment/HHS-ASPE-2026-0298-0145
Air Line Pilots Association: FAA Moves Toward Allowing Supersonic Overland Flight Under New Noise Standards
Carter Struck
WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
August 17, 2026
U.S. Department of Transportation
Docket Operations, M-30
West Building Ground Floor
Room W12-140
1200 New Jersey Avenue, SE
Washington, DC 20590
Subject:
Docket No.: FAA-2026-6935; Notice No.26-07 RIN 2120-AM15
Enabling Supersonic Overland Flight
IN SUPPORT WITH COMMENT
Dear Sir or Madam:
The Air Line Pilots Association (ALPA), representing the safety interests of more than 80,000 professional ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 17, 2026 U.S. Department of Transportation Docket Operations, M-30 West Building Ground Floor Room W12-140 1200 New Jersey Avenue, SE Washington, DC 20590 Subject: Docket No.: FAA-2026-6935; Notice No.26-07 RIN 2120-AM15 Enabling Supersonic Overland Flight IN SUPPORT WITH COMMENT Dear Sir or Madam: The Air Line Pilots Association (ALPA), representing the safety interests of more than 80,000 professionalairline pilots flying for 42 airlines in the United States and Canada, has reviewed the subject document.
On July 2, 2026, the FAA published a notice of proposed rulemaking (NPRM) that would repeal the 53-year-old ban on civil supersonic flight over U.S. land and replace it with a performance-based noise standard: aircraft may exceed Mach 1 overland if sonic boom overpressure at the surface stays at or below 0.11 pounds per square foot (psf). The rule implements Executive Order 14304, "Leading the World in Supersonic Flight" (June 6, 2025), and is framed as the first of several rulemakings - it covers only en route noise, leaving landing-and-takeoff (LTO) noise standards to a later, separate rulemaking activity.
The NPRM revises 14 CFR Sec. 91.817 (retitled "Civil Supersonic Flight") and makes conforming changes to Sec. 91.818. Its core elements:
Repealing the speed-based prohibition
Since 1973, Sec. 91.817 has barred any civil aircraft from exceeding Mach 1 over the U.S. except under an individually issued Special Flight Authorization (SFA) - only four have ever been granted. FAA proposes to repeal this blanket ban and replace it with a noise-based standard that does not depend on speed at all.
Instituting the 0.11 psf noise threshold
Proposing to allow supersonic overland flight only if sonic boom overpressure at the surface, covering primary booms, secondary "direct" booms, and secondary "indirect" booms, does not exceed 0.11 psf.
Replacing the SFA with a three-part authorization pathway
Allowing authorization of supersonic overland without a per-flight SFA if the operator:
o operates within the 0.11 psf limit,
o demonstrates to FAA- by measurement, modeling, or another FAA-approved method- and receives an Administrator "finding", and
o complies with any FAA-issued conditions and limitations. Once granted, the finding is durable rather than per-flight or per-area, a significant procedural loosening relative to today's SFA process.
Limiting scope to en-route noise only
This rule addresses only the en route (cruise) sonic boom. Landing-and-takeoff (LTO) noise standards are explicitly reserved for a future rulemaking, and FAA does not expect to receive supersonic type-certificate applications until that rule exists. The SFA process remains available, unchanged, for research and testing where booms may reach the surface in controlled areas.
Potential Gaps
While ALPA supports the NPRM, there are potential gaps as it pertains to compliance and verification of the proposed noise threshold:
o Should an operator demonstrate initial compliance during flight test, how will an operator be able to ensure this limit is continuously met during actual operations, and how does the FAA intend to verify this continued compliance?
Different combinations of aircraft speed, maneuvers, aerodynamics, and atmospheric conditions could result in different pressure waves. Avoiding exceedances, given variances in atmospheric conditions throughout the entire airplane's flight envelope, presently seems implausible.
o The 0.11 psf limit is the only substantive limit described in the NPRM. The cumulative effects of multiple pressure waves over time should be evaluated and taken into consideration.
A singular pressure wave at 0.11 psf perhaps may not be a nuisance, however, multiple supersonic operations over a concentrated area, would set off a repetitive sequence of pressure waves, which may be a nuisance to the public.
The NPRM states operators would be required to operate under any conditions and limitations issued by the Administrator. It is imperative that affected stakeholders are consulted prior to the FAA publishing any special conditions or exemptions, particularly due to supersonic flight being nascent.
Additionally, emergent manufacturing designs resulting from, or in response to, these regulatory changes should be meticulously evaluated, maintaining the current standard of safety assessment. Any relaxation, such as OEMs and operators developing their own means of compliance, must not result in a transfer of authority or a reduction in the regulator-imposed safety margins previously in place.
ALPA is a proponet for technological advancement for the enhancement of safety. With respect to long-standing regulations however, change should be gradual, sufficiently demonstrating achievement of the same or higher level of safety.
Sincerely,
Captain Christopher W. Sidor
Aircraft Design and Operations Group (ADO), Chair
Air Line Pilots Association, International
Air Safety Organization (ASO)
*
Original text of letter here: https://www.regulations.gov/comment/FAA-2026-6935-0468
August 17, 2026
U.S. Department of Transportation
Docket Operations, M-30
West Building Ground Floor
Room W12-140
1200 New Jersey Avenue, SE
Washington, DC 20590
Subject:
Docket No.: FAA-2026-6935; Notice No.26-07 RIN 2120-AM15
Enabling Supersonic Overland Flight
IN SUPPORT WITH COMMENT
Dear Sir or Madam:
The Air Line Pilots Association (ALPA), representing the safety interests of more than 80,000 professional ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 17, 2026 U.S. Department of Transportation Docket Operations, M-30 West Building Ground Floor Room W12-140 1200 New Jersey Avenue, SE Washington, DC 20590 Subject: Docket No.: FAA-2026-6935; Notice No.26-07 RIN 2120-AM15 Enabling Supersonic Overland Flight IN SUPPORT WITH COMMENT Dear Sir or Madam: The Air Line Pilots Association (ALPA), representing the safety interests of more than 80,000 professionalairline pilots flying for 42 airlines in the United States and Canada, has reviewed the subject document.
On July 2, 2026, the FAA published a notice of proposed rulemaking (NPRM) that would repeal the 53-year-old ban on civil supersonic flight over U.S. land and replace it with a performance-based noise standard: aircraft may exceed Mach 1 overland if sonic boom overpressure at the surface stays at or below 0.11 pounds per square foot (psf). The rule implements Executive Order 14304, "Leading the World in Supersonic Flight" (June 6, 2025), and is framed as the first of several rulemakings - it covers only en route noise, leaving landing-and-takeoff (LTO) noise standards to a later, separate rulemaking activity.
The NPRM revises 14 CFR Sec. 91.817 (retitled "Civil Supersonic Flight") and makes conforming changes to Sec. 91.818. Its core elements:
Repealing the speed-based prohibition
Since 1973, Sec. 91.817 has barred any civil aircraft from exceeding Mach 1 over the U.S. except under an individually issued Special Flight Authorization (SFA) - only four have ever been granted. FAA proposes to repeal this blanket ban and replace it with a noise-based standard that does not depend on speed at all.
Instituting the 0.11 psf noise threshold
Proposing to allow supersonic overland flight only if sonic boom overpressure at the surface, covering primary booms, secondary "direct" booms, and secondary "indirect" booms, does not exceed 0.11 psf.
Replacing the SFA with a three-part authorization pathway
Allowing authorization of supersonic overland without a per-flight SFA if the operator:
o operates within the 0.11 psf limit,
o demonstrates to FAA- by measurement, modeling, or another FAA-approved method- and receives an Administrator "finding", and
o complies with any FAA-issued conditions and limitations. Once granted, the finding is durable rather than per-flight or per-area, a significant procedural loosening relative to today's SFA process.
Limiting scope to en-route noise only
This rule addresses only the en route (cruise) sonic boom. Landing-and-takeoff (LTO) noise standards are explicitly reserved for a future rulemaking, and FAA does not expect to receive supersonic type-certificate applications until that rule exists. The SFA process remains available, unchanged, for research and testing where booms may reach the surface in controlled areas.
Potential Gaps
While ALPA supports the NPRM, there are potential gaps as it pertains to compliance and verification of the proposed noise threshold:
o Should an operator demonstrate initial compliance during flight test, how will an operator be able to ensure this limit is continuously met during actual operations, and how does the FAA intend to verify this continued compliance?
Different combinations of aircraft speed, maneuvers, aerodynamics, and atmospheric conditions could result in different pressure waves. Avoiding exceedances, given variances in atmospheric conditions throughout the entire airplane's flight envelope, presently seems implausible.
o The 0.11 psf limit is the only substantive limit described in the NPRM. The cumulative effects of multiple pressure waves over time should be evaluated and taken into consideration.
A singular pressure wave at 0.11 psf perhaps may not be a nuisance, however, multiple supersonic operations over a concentrated area, would set off a repetitive sequence of pressure waves, which may be a nuisance to the public.
The NPRM states operators would be required to operate under any conditions and limitations issued by the Administrator. It is imperative that affected stakeholders are consulted prior to the FAA publishing any special conditions or exemptions, particularly due to supersonic flight being nascent.
Additionally, emergent manufacturing designs resulting from, or in response to, these regulatory changes should be meticulously evaluated, maintaining the current standard of safety assessment. Any relaxation, such as OEMs and operators developing their own means of compliance, must not result in a transfer of authority or a reduction in the regulator-imposed safety margins previously in place.
ALPA is a proponet for technological advancement for the enhancement of safety. With respect to long-standing regulations however, change should be gradual, sufficiently demonstrating achievement of the same or higher level of safety.
Sincerely,
Captain Christopher W. Sidor
Aircraft Design and Operations Group (ADO), Chair
Air Line Pilots Association, International
Air Safety Organization (ASO)
*
Original text of letter here: https://www.regulations.gov/comment/FAA-2026-6935-0468
4 Environmental Groups Applaud Tiered Approach to Grizzly Bear Protections and Call for Clarification
Carter Struck
WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
Comment on the Proposed Revisions to the Protective Regulations for Grizzly Bears, RIN 1018-BI14 Property and Environment Research Center, Rocky Mountain Elk Foundation, Boone and Crockett Club, and Wyoming Wildlife Federation August 17, 2026 Dir. Nesvik,
The Property and Environment Research Center, Rocky Mountain Elk Foundation, Boone and Crockett Club, and Wyoming Wildlife Federation applaud the Fish and Wildlife Service ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. Comment on the Proposed Revisions to the Protective Regulations for Grizzly Bears, RIN 1018-BI14 Property and Environment Research Center, Rocky Mountain Elk Foundation, Boone and Crockett Club, and Wyoming Wildlife Federation August 17, 2026 Dir. Nesvik, The Property and Environment Research Center, Rocky Mountain Elk Foundation, Boone and Crockett Club, and Wyoming Wildlife Federation applaud the Fish and Wildlife Servicefor its proposal to separate the revision to the grizzly bear listing from the revision of the 4(d) rule-and to embrace an innovative tiered approach to the 4(d) rule that encourages and extends recovery progress.1
This new approach is a fitting next step for one of the Endangered Species Act's signature conservation success stories: Increasing the Greater Yellowstone Ecosystem population from a mere 136 bears in 1975 to more than 1,055 bears today. Abandoning the previously proposed "distinct population segment" (DPS) ensures the 4(d) revision can carry that progress forward to eventual de-listing.
The controversial DPS proposal-based on a strained interpretation of "distinct population segment" that disregards connectivity between bears in the lower 48 and Canada while penalizing connectivity between populations in the lower 48-contradicts Congressional intent on when this provision should be applied. It should be discarded. The Service has never adequately explained the ecological significance of international boundaries nor why the significance of the southern portion of the grizzly's range in North America requires anything more than the successful recovery program we have. The 1996 policy on which the needless DPS proposal was based needs reform, but that reconsideration should not delay a much needed revision to the 4(d) rule.2
See Prop. & Envt. Res. Center et al., Comment on the Proposed Grizzly Bear Listing with a Revised 4(d) Rule (May 16, 2025).1 Fish & Wildlife Serv., Proposed Revision of the Grizzly Bear Protective Regulations Under Section 4(d), 91 Fed. Reg. 44,780 (July 17, 2026).
We are especially pleased that the Service has proposed a "tiered" approach to authorizing state management because this adapts recovery policy to the new issues raised by the returning abundance of bears. Addressing those issues will improve social tolerance of bears and increase support for continued conservation progress-and it will also facilitate the eventual transition to full state management upon eventual delisting. We proposed such a tiered approach for these reasons in our comment on the Service's 2025 proposal.3 Rather than repeat everything we said in that comment, we incorporate it by reference and summarize its main points below. This is a truly innovative approach that promises to improve conservation not only of grizzly bears but many other species.
To date, 4(d) rules have been written statically, taking no account for whether species are improving or declining. The tiered approach, by contrast, makes progress a core structural feature of the rule. It sets demographic objectives for each area and provides enhanced regulatory flexibility for meeting them. This approach provides stronger incentives for progress, allows for a more gradual transition to state management, ties flexibility to areas of abundance, and allows states to build trust in their management prior to delisting. The tiered approach also respects the expertise and role of state wildlife agencies. While the proposed rule refers to states as in "a unique position to assist" in implementing the Endangered Species Act, the reality is that states have been leaders in carrying out grizzly conservation. Under the tiered approach, state agencies will be able to act on their own expertise in areas that have met benchmarks.
They are also provided a path to state management as other areas achieve goals. The proposed rule additionally lowers the stakes of future delisting decisions by breaking the rigid connection between delisting and state management. A tiered approach acts as a sort of insurance policy against future delisting litigation, by locking in a degree of flexibility and state management that would not be disturbed if a future delisting is overturned. And it would allow that delisting decision to be informed by real-world evidence about "existing regulatory mechanisms" rather than speculation. So we commend the Service for embracing this innovative tiered approach. And we offer these additional thoughts to further strengthen the proposed rule to improve clarity and avoid future conflict: 1)
Incorporate goals and flexibility into the rule itself, rather than relying on an uncertain and discretionary MOU process Under the proposed rule, demographic objectives and the transfer of management authority to states is deferred to a subsequent conservation strategy and MOU rather than resolved in the rule. That reliance on a new, uncertain, and apparently discretionary agency process is not necessary because local area objectives already exist in the recovery plan. An uncertain replacement also needlessly raises concerns from both supporters and critics of the general concept of the tiered approach. States and conservation groups like ours have expressed concern that the Service may fail to fully honor the promises of this 3
Id. A copy of this comment has been included as an attachment.
rule by setting unreasonable demographic objectives or withholding flexibility even if they are met.4 Some other environmental groups have expressed the opposite concern, fearing that objectives will be set unreasonably low or will not be enforced.5 Since this aspect of the proposed rule maximizes the Fish and Wildlife Service's ongoing discretion, rather than providing clear, enforceable standards, both concerns are plausible. We recommend the Service provide the demographic objectives in the rule itself and make the additional flexibility triggered by them automatically. This would avoid imposing additional, needless paperwork burdens on state wildlife agencies. And the Service has taken this approach before, in the only other 4(d) rule that adopts something like this tiered model.
The 4(d) rule for the Mexican wolf uses the size of the breeding age population as a trigger for additional state flexibility to manage wolves to address impacts to native ungulates, among other flexibilities.6 Because the Service has already developed a recovery plan for the grizzly bear and has decades of information about population growth and habitat, it is a good candidate to include clear, objective criteria in the rule itself to be used as the trigger for increased flexibility-and to provide (or withdraw) that flexibility-rather than relying on a separate, discretionary MOU process. This would provide clarity to everyone about expectations and how the rule would work. Incorporating these details into the regulation rather than relying on a later MOU would also reduce litigation risk.
Under the proposed rule, the future conservation strategies and MOUs are potentially vulnerable to litigation. Because they change the operation of the proposed 4(d) rule, opponents of flexibility may argue that the MOUs are themselves rules that must be formally adopted through notice and comment procedures. Incorporating everything into the rule itself, on the other hand, eliminates this concern and needs only to satisfy Section 4(d)'s flexible "necessary and advisable for the conservation of the species" standard. The use of explicit biological triggers for increased flexibility has been specifically upheld under that standard.7
2)
Clarify the scope of the Tier 2 exception for incidental take for landowners The previous proposal contained several explicit exemptions for ranchers and other private landowners. The current proposal replaces them with an incidental take exemption for areas in Tier 2 status. However, the proposed rule contains a new definition of incidental take that is inconsistent 7
See Center for Biological Diversity v. Haaland, 22-cv-00303, 2025 WL 981686 (D. Ariz. 2025) 6 50 C.F.R. Sec. 17.84(k). 5 The proposed rule provides that the Service "may" revoke Tier 2 status if the objectives are not met but does not require the status to be revoked and federal regulation restored in any circumstances. 4 As written, the proposed rule makes an area meeting the demographic objectives a necessary condition of Tier 2 status, but not necessarily a sufficient condition. States must demonstrate objectives are met to qualify for Tier 2.
But the rule doesn't require the Service to grant a state Tier 2 status whenever the objectives are met. with the established understanding of this phrase, narrows the effect of this exemption substantially, and creates unnecessary confusion.8 No explanation is offered for this narrowing of "incidental take." We encourage you to use the ordinary definition of incidental take for this rule or provide greater clarity about how this bespoke definition affects Tier 2 status. If the new definition is retained, the Service should offer some justification for it. It should also provide a nonexhaustive list of circumstances in which state and landowner activity will be covered by the incidental take exemption under Tier 2. And it should identify actions that would be incidental take under the ordinary definition but would be excluded under this proposed definition. Providing this clarity now will avoid future confusion and conflict later, benefiting states, landowners, and bears. Conclusion Thank you again for your leadership in conservation and embrace of this innovative tiered 4(d) rule approach. We applaud the proposal and offer these suggestions to improve clarity, reduce conflict, and streamline administration of the rule. We look forward to the final rule's release and the conservation it unleashes.8
Compare 50 C.F.R. Sec. 17.3 (defining "incidental take" generally as take "incidental to, and not the purpose of, the carrying out of an otherwise lawful activity") with 91 Fed. Reg. 44,780, 44,794 (adding to the general definition that take must also be "unintentional and not due to negligent conduct" and further excluding take that results from misidentification of a species during a lawful activity).
*
Original text of letter here: https://www.regulations.gov/comment/FWS-R6-ES-2024-0186-106462
Comment on the Proposed Revisions to the Protective Regulations for Grizzly Bears, RIN 1018-BI14 Property and Environment Research Center, Rocky Mountain Elk Foundation, Boone and Crockett Club, and Wyoming Wildlife Federation August 17, 2026 Dir. Nesvik,
The Property and Environment Research Center, Rocky Mountain Elk Foundation, Boone and Crockett Club, and Wyoming Wildlife Federation applaud the Fish and Wildlife Service ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. Comment on the Proposed Revisions to the Protective Regulations for Grizzly Bears, RIN 1018-BI14 Property and Environment Research Center, Rocky Mountain Elk Foundation, Boone and Crockett Club, and Wyoming Wildlife Federation August 17, 2026 Dir. Nesvik, The Property and Environment Research Center, Rocky Mountain Elk Foundation, Boone and Crockett Club, and Wyoming Wildlife Federation applaud the Fish and Wildlife Servicefor its proposal to separate the revision to the grizzly bear listing from the revision of the 4(d) rule-and to embrace an innovative tiered approach to the 4(d) rule that encourages and extends recovery progress.1
This new approach is a fitting next step for one of the Endangered Species Act's signature conservation success stories: Increasing the Greater Yellowstone Ecosystem population from a mere 136 bears in 1975 to more than 1,055 bears today. Abandoning the previously proposed "distinct population segment" (DPS) ensures the 4(d) revision can carry that progress forward to eventual de-listing.
The controversial DPS proposal-based on a strained interpretation of "distinct population segment" that disregards connectivity between bears in the lower 48 and Canada while penalizing connectivity between populations in the lower 48-contradicts Congressional intent on when this provision should be applied. It should be discarded. The Service has never adequately explained the ecological significance of international boundaries nor why the significance of the southern portion of the grizzly's range in North America requires anything more than the successful recovery program we have. The 1996 policy on which the needless DPS proposal was based needs reform, but that reconsideration should not delay a much needed revision to the 4(d) rule.2
See Prop. & Envt. Res. Center et al., Comment on the Proposed Grizzly Bear Listing with a Revised 4(d) Rule (May 16, 2025).1 Fish & Wildlife Serv., Proposed Revision of the Grizzly Bear Protective Regulations Under Section 4(d), 91 Fed. Reg. 44,780 (July 17, 2026).
We are especially pleased that the Service has proposed a "tiered" approach to authorizing state management because this adapts recovery policy to the new issues raised by the returning abundance of bears. Addressing those issues will improve social tolerance of bears and increase support for continued conservation progress-and it will also facilitate the eventual transition to full state management upon eventual delisting. We proposed such a tiered approach for these reasons in our comment on the Service's 2025 proposal.3 Rather than repeat everything we said in that comment, we incorporate it by reference and summarize its main points below. This is a truly innovative approach that promises to improve conservation not only of grizzly bears but many other species.
To date, 4(d) rules have been written statically, taking no account for whether species are improving or declining. The tiered approach, by contrast, makes progress a core structural feature of the rule. It sets demographic objectives for each area and provides enhanced regulatory flexibility for meeting them. This approach provides stronger incentives for progress, allows for a more gradual transition to state management, ties flexibility to areas of abundance, and allows states to build trust in their management prior to delisting. The tiered approach also respects the expertise and role of state wildlife agencies. While the proposed rule refers to states as in "a unique position to assist" in implementing the Endangered Species Act, the reality is that states have been leaders in carrying out grizzly conservation. Under the tiered approach, state agencies will be able to act on their own expertise in areas that have met benchmarks.
They are also provided a path to state management as other areas achieve goals. The proposed rule additionally lowers the stakes of future delisting decisions by breaking the rigid connection between delisting and state management. A tiered approach acts as a sort of insurance policy against future delisting litigation, by locking in a degree of flexibility and state management that would not be disturbed if a future delisting is overturned. And it would allow that delisting decision to be informed by real-world evidence about "existing regulatory mechanisms" rather than speculation. So we commend the Service for embracing this innovative tiered approach. And we offer these additional thoughts to further strengthen the proposed rule to improve clarity and avoid future conflict: 1)
Incorporate goals and flexibility into the rule itself, rather than relying on an uncertain and discretionary MOU process Under the proposed rule, demographic objectives and the transfer of management authority to states is deferred to a subsequent conservation strategy and MOU rather than resolved in the rule. That reliance on a new, uncertain, and apparently discretionary agency process is not necessary because local area objectives already exist in the recovery plan. An uncertain replacement also needlessly raises concerns from both supporters and critics of the general concept of the tiered approach. States and conservation groups like ours have expressed concern that the Service may fail to fully honor the promises of this 3
Id. A copy of this comment has been included as an attachment.
rule by setting unreasonable demographic objectives or withholding flexibility even if they are met.4 Some other environmental groups have expressed the opposite concern, fearing that objectives will be set unreasonably low or will not be enforced.5 Since this aspect of the proposed rule maximizes the Fish and Wildlife Service's ongoing discretion, rather than providing clear, enforceable standards, both concerns are plausible. We recommend the Service provide the demographic objectives in the rule itself and make the additional flexibility triggered by them automatically. This would avoid imposing additional, needless paperwork burdens on state wildlife agencies. And the Service has taken this approach before, in the only other 4(d) rule that adopts something like this tiered model.
The 4(d) rule for the Mexican wolf uses the size of the breeding age population as a trigger for additional state flexibility to manage wolves to address impacts to native ungulates, among other flexibilities.6 Because the Service has already developed a recovery plan for the grizzly bear and has decades of information about population growth and habitat, it is a good candidate to include clear, objective criteria in the rule itself to be used as the trigger for increased flexibility-and to provide (or withdraw) that flexibility-rather than relying on a separate, discretionary MOU process. This would provide clarity to everyone about expectations and how the rule would work. Incorporating these details into the regulation rather than relying on a later MOU would also reduce litigation risk.
Under the proposed rule, the future conservation strategies and MOUs are potentially vulnerable to litigation. Because they change the operation of the proposed 4(d) rule, opponents of flexibility may argue that the MOUs are themselves rules that must be formally adopted through notice and comment procedures. Incorporating everything into the rule itself, on the other hand, eliminates this concern and needs only to satisfy Section 4(d)'s flexible "necessary and advisable for the conservation of the species" standard. The use of explicit biological triggers for increased flexibility has been specifically upheld under that standard.7
2)
Clarify the scope of the Tier 2 exception for incidental take for landowners The previous proposal contained several explicit exemptions for ranchers and other private landowners. The current proposal replaces them with an incidental take exemption for areas in Tier 2 status. However, the proposed rule contains a new definition of incidental take that is inconsistent 7
See Center for Biological Diversity v. Haaland, 22-cv-00303, 2025 WL 981686 (D. Ariz. 2025) 6 50 C.F.R. Sec. 17.84(k). 5 The proposed rule provides that the Service "may" revoke Tier 2 status if the objectives are not met but does not require the status to be revoked and federal regulation restored in any circumstances. 4 As written, the proposed rule makes an area meeting the demographic objectives a necessary condition of Tier 2 status, but not necessarily a sufficient condition. States must demonstrate objectives are met to qualify for Tier 2.
But the rule doesn't require the Service to grant a state Tier 2 status whenever the objectives are met. with the established understanding of this phrase, narrows the effect of this exemption substantially, and creates unnecessary confusion.8 No explanation is offered for this narrowing of "incidental take." We encourage you to use the ordinary definition of incidental take for this rule or provide greater clarity about how this bespoke definition affects Tier 2 status. If the new definition is retained, the Service should offer some justification for it. It should also provide a nonexhaustive list of circumstances in which state and landowner activity will be covered by the incidental take exemption under Tier 2. And it should identify actions that would be incidental take under the ordinary definition but would be excluded under this proposed definition. Providing this clarity now will avoid future confusion and conflict later, benefiting states, landowners, and bears. Conclusion Thank you again for your leadership in conservation and embrace of this innovative tiered 4(d) rule approach. We applaud the proposal and offer these suggestions to improve clarity, reduce conflict, and streamline administration of the rule. We look forward to the final rule's release and the conservation it unleashes.8
Compare 50 C.F.R. Sec. 17.3 (defining "incidental take" generally as take "incidental to, and not the purpose of, the carrying out of an otherwise lawful activity") with 91 Fed. Reg. 44,780, 44,794 (adding to the general definition that take must also be "unintentional and not due to negligent conduct" and further excluding take that results from misidentification of a species during a lawful activity).
*
Original text of letter here: https://www.regulations.gov/comment/FWS-R6-ES-2024-0186-106462
2GenPen LLC Supports Modernization of CAMELS Framework With AI and Data Analytics
Carter Struck
WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
2GenPen LLC | FFIEC Docket ID OCC-2026-0562
COMMENT OF 2GENPEN LLC
Uniform Financial Institutions Rating System (CAMELS)
FFIEC | Docket ID OCC-2026-0562 | August 17, 2026
Submitted by
2GenPen LLC
Re
Proposed Revisions to the Uniform Financial Institutions Rating System (CAMELS)
Federal Register
91 Fed. Reg. 29128 (May 19, 2026)
2GenPen LLC respectfully submits these comments in strong support of the FFIEC's proposed ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. 2GenPen LLC | FFIEC Docket ID OCC-2026-0562 COMMENT OF 2GENPEN LLC Uniform Financial Institutions Rating System (CAMELS) FFIEC | Docket ID OCC-2026-0562 | August 17, 2026 Submitted by 2GenPen LLC Re Proposed Revisions to the Uniform Financial Institutions Rating System (CAMELS) Federal Register 91 Fed. Reg. 29128 (May 19, 2026) 2GenPen LLC respectfully submits these comments in strong support of the FFIEC's proposedmodernization of the Uniform Financial Institutions Rating System. The proposal's central objective-strengthening the link between supervisory ratings and safety and soundness by focusing on material financial risks, while improving transparency and predictability-is both timely and important.
The proposed revisions also arrive at a consequential technological moment. The availability of large financial datasets, inexpensive computation, and increasingly sophisticated artificial intelligence and machine-learning tools now makes it possible to evaluate financial risk more continuously, consistently, and empirically than when the CAMELS framework was last comprehensively revised. The final framework should preserve room for supervisory practice to benefit from these capabilities as they are independently validated and responsibly governed.
1. The proposed focus on material financial risk should be retained and strengthened.
2GenPen agrees with the FFIEC's decision to reduce reliance on process-oriented deficiencies that do not materially affect an institution's financial condition and to focus component and composite ratings on risks that can impair capital, asset quality, earnings, liquidity, or sensitivity to market conditions. This approach should improve the informational content of CAMELS ratings and reduce the risk that immaterial procedural concerns obscure more consequential financial vulnerabilities.
In response to Questions 1 and 2, we recommend that the final framework state as clearly as practicable that supervisory ratings should be anchored to observable financial consequences and credible pathways through which identified risks could impair an institution's ability to remain safe and sound. Where judgment is required, the framework should encourage examiners to distinguish between the existence of a weakness and the magnitude, transmission mechanism, and financial materiality of that weakness.
2. "Evolving business practices" should expressly include validated AI/ML-based risk intelligence.
Question 3 appropriately asks how the agencies should consider evolving business practices. We believe the answer should include the rapidly expanding use of explainable artificial intelligence, machine learning, high-dimensional data analysis, scenario testing, and continuous risk monitoring. These technologies can supplement-not replace-examiner judgment by identifying relationships among financial, structural, legal, market, and behavioral variables that may be difficult to observe through static ratios or categorical assessments alone.
The final framework need not endorse any particular vendor, model, or technology. It should instead remain technology-neutral while recognizing that independently validated quantitative tools may provide useful evidence regarding material financial risk. A model should earn supervisory relevance through empirical performance, transparency, reproducibility, data provenance, sensitivity analysis, bias testing, model-risk governance, and clear disclosure of limitations.
2GenPen LLC | FFIEC Docket ID OCC-2026-0562
3. The FFIEC should encourage independent, explainable analytical layers rather than new black boxes.
The modernization objective will be best served if increased quantification does not simply substitute one opaque judgment for another. Modern analytical systems can preserve the factors underlying a conclusion, express risk on continuous rather than solely categorical scales, and show how an institution's risk state changes as assumptions and economic conditions change. That capability is particularly relevant where different portfolios, asset classes, or business models can appear similar under broad supervisory categories while possessing materially different pathways to impairment.
2GenPen has developed patented AI/ML-based credit-intelligence technologies that are designed around this principle: heterogeneous quantitative and qualitative information can be organized into a common, explainable analytical architecture and tested against empirical outcomes. We do not ask the FFIEC in this proceeding to adopt or recognize any proprietary model. We cite our work only to demonstrate that the technological capability contemplated above is no longer theoretical and that the final CAMELS framework should be sufficiently flexible to accommodate validated advances in risk measurement.
4. Recommended addition to the final framework.
We respectfully recommend that the FFIEC incorporate language, either in the final UFIRS text or accompanying supervisory guidance, substantially reflecting the following principle:
In evaluating material financial risk, examiners may consider relevant, independently validated quantitative and technology-enabled analytical tools where such tools are empirically grounded, explainable, reproducible, appropriately governed, and suitable to the institution's size, complexity, activities, and risk profile.
We further encourage the agencies, following adoption of the revised framework, to consider controlled supervisory pilots or technical consultations through which emerging analytical methods can be evaluated against historical and prospective outcomes. Such a process would allow innovation to inform supervision without lowering validation standards or compromising examiner independence.
Conclusion
The proposed revisions appropriately move CAMELS toward a more transparent, measurable, and financially consequential assessment of safety and soundness. The opportunity is not merely to modernize the wording of a framework created in an earlier era, but to ensure that the framework remains capable of incorporating better evidence as the tools available to identify, measure, monitor, and control material financial risk continue to evolve.
2GenPen respectfully supports the direction of the proposal and encourages the FFIEC to preserve a clear pathway for independently validated, explainable AI/ML-based risk intelligence to supplement supervisory judgment and advance the shared objective of more informed, consistent, and risk-sensitive supervision.
Respectfully submitted,
Laurence H. Wadler
Co-Founder and Chief Executive Officer
2GenPen LLC
*
Original text of letter here: https://www.regulations.gov/comment/OCC-2026-0562-0063
2GenPen LLC | FFIEC Docket ID OCC-2026-0562
COMMENT OF 2GENPEN LLC
Uniform Financial Institutions Rating System (CAMELS)
FFIEC | Docket ID OCC-2026-0562 | August 17, 2026
Submitted by
2GenPen LLC
Re
Proposed Revisions to the Uniform Financial Institutions Rating System (CAMELS)
Federal Register
91 Fed. Reg. 29128 (May 19, 2026)
2GenPen LLC respectfully submits these comments in strong support of the FFIEC's proposed ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. 2GenPen LLC | FFIEC Docket ID OCC-2026-0562 COMMENT OF 2GENPEN LLC Uniform Financial Institutions Rating System (CAMELS) FFIEC | Docket ID OCC-2026-0562 | August 17, 2026 Submitted by 2GenPen LLC Re Proposed Revisions to the Uniform Financial Institutions Rating System (CAMELS) Federal Register 91 Fed. Reg. 29128 (May 19, 2026) 2GenPen LLC respectfully submits these comments in strong support of the FFIEC's proposedmodernization of the Uniform Financial Institutions Rating System. The proposal's central objective-strengthening the link between supervisory ratings and safety and soundness by focusing on material financial risks, while improving transparency and predictability-is both timely and important.
The proposed revisions also arrive at a consequential technological moment. The availability of large financial datasets, inexpensive computation, and increasingly sophisticated artificial intelligence and machine-learning tools now makes it possible to evaluate financial risk more continuously, consistently, and empirically than when the CAMELS framework was last comprehensively revised. The final framework should preserve room for supervisory practice to benefit from these capabilities as they are independently validated and responsibly governed.
1. The proposed focus on material financial risk should be retained and strengthened.
2GenPen agrees with the FFIEC's decision to reduce reliance on process-oriented deficiencies that do not materially affect an institution's financial condition and to focus component and composite ratings on risks that can impair capital, asset quality, earnings, liquidity, or sensitivity to market conditions. This approach should improve the informational content of CAMELS ratings and reduce the risk that immaterial procedural concerns obscure more consequential financial vulnerabilities.
In response to Questions 1 and 2, we recommend that the final framework state as clearly as practicable that supervisory ratings should be anchored to observable financial consequences and credible pathways through which identified risks could impair an institution's ability to remain safe and sound. Where judgment is required, the framework should encourage examiners to distinguish between the existence of a weakness and the magnitude, transmission mechanism, and financial materiality of that weakness.
2. "Evolving business practices" should expressly include validated AI/ML-based risk intelligence.
Question 3 appropriately asks how the agencies should consider evolving business practices. We believe the answer should include the rapidly expanding use of explainable artificial intelligence, machine learning, high-dimensional data analysis, scenario testing, and continuous risk monitoring. These technologies can supplement-not replace-examiner judgment by identifying relationships among financial, structural, legal, market, and behavioral variables that may be difficult to observe through static ratios or categorical assessments alone.
The final framework need not endorse any particular vendor, model, or technology. It should instead remain technology-neutral while recognizing that independently validated quantitative tools may provide useful evidence regarding material financial risk. A model should earn supervisory relevance through empirical performance, transparency, reproducibility, data provenance, sensitivity analysis, bias testing, model-risk governance, and clear disclosure of limitations.
2GenPen LLC | FFIEC Docket ID OCC-2026-0562
3. The FFIEC should encourage independent, explainable analytical layers rather than new black boxes.
The modernization objective will be best served if increased quantification does not simply substitute one opaque judgment for another. Modern analytical systems can preserve the factors underlying a conclusion, express risk on continuous rather than solely categorical scales, and show how an institution's risk state changes as assumptions and economic conditions change. That capability is particularly relevant where different portfolios, asset classes, or business models can appear similar under broad supervisory categories while possessing materially different pathways to impairment.
2GenPen has developed patented AI/ML-based credit-intelligence technologies that are designed around this principle: heterogeneous quantitative and qualitative information can be organized into a common, explainable analytical architecture and tested against empirical outcomes. We do not ask the FFIEC in this proceeding to adopt or recognize any proprietary model. We cite our work only to demonstrate that the technological capability contemplated above is no longer theoretical and that the final CAMELS framework should be sufficiently flexible to accommodate validated advances in risk measurement.
4. Recommended addition to the final framework.
We respectfully recommend that the FFIEC incorporate language, either in the final UFIRS text or accompanying supervisory guidance, substantially reflecting the following principle:
In evaluating material financial risk, examiners may consider relevant, independently validated quantitative and technology-enabled analytical tools where such tools are empirically grounded, explainable, reproducible, appropriately governed, and suitable to the institution's size, complexity, activities, and risk profile.
We further encourage the agencies, following adoption of the revised framework, to consider controlled supervisory pilots or technical consultations through which emerging analytical methods can be evaluated against historical and prospective outcomes. Such a process would allow innovation to inform supervision without lowering validation standards or compromising examiner independence.
Conclusion
The proposed revisions appropriately move CAMELS toward a more transparent, measurable, and financially consequential assessment of safety and soundness. The opportunity is not merely to modernize the wording of a framework created in an earlier era, but to ensure that the framework remains capable of incorporating better evidence as the tools available to identify, measure, monitor, and control material financial risk continue to evolve.
2GenPen respectfully supports the direction of the proposal and encourages the FFIEC to preserve a clear pathway for independently validated, explainable AI/ML-based risk intelligence to supplement supervisory judgment and advance the shared objective of more informed, consistent, and risk-sensitive supervision.
Respectfully submitted,
Laurence H. Wadler
Co-Founder and Chief Executive Officer
2GenPen LLC
*
Original text of letter here: https://www.regulations.gov/comment/OCC-2026-0562-0063
11 U.S. Congress Members Urge NMFS Approval of Expanded Recreational Red Snapper Fishing Pilot Programs
Carter Struck
WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site.
August 17, 2026
Mr. Andy Strelcheck
Southeast Regional Office
National Marine Fisheries Service
263 13th Avenue South
St. Petersburg, FL 33701.
Re: Exempted Fishing Permit Applications in the South Atlantic
Position: Support
Dear Mr. Strelcheck,
As leaders of the state legislative sportsmen's caucuses in Florida, Georgia, and South Carolina, we write to express our strong support for the new Exempted Fishing Permit ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 17, 2026 Mr. Andy Strelcheck Southeast Regional Office National Marine Fisheries Service 263 13th Avenue South St. Petersburg, FL 33701. Re: Exempted Fishing Permit Applications in the South Atlantic Position: Support Dear Mr. Strelcheck, As leaders of the state legislative sportsmen's caucuses in Florida, Georgia, and South Carolina, we write to express our strong support for the new Exempted Fishing Permit(EFP) applications submitted by our respective state fish and wildlife agencies concerning the recreational red snapper fishery in the South Atlantic. We appreciate the National Marine Fisheries Service's continued consideration of innovative, state-driven approaches that can improve recreational fisheries data collection, strengthen conservation, and provide anglers with meaningful fishing opportunities. The EFP applications submitted by the Florida Fish and Wildlife Conservation Commission, Georgia Department of Natural Resources, and South Carolina Department of Natural Resources represent a constructive partnership between state and federal fishery managers. The proposals would allow our states to pilot extended recreational red snapper fishing opportunities while implementing enhanced state-based data collection and reporting programs. Florida would build upon its State Reef Fish Survey while testing voluntary electronic reporting, while Georgia and South Carolina would utilize mandatory electronic reporting to collect timely, trip-level information on fishing effort, harvest, and releases. Importantly, these proposals are designed to test management approaches that can produce better information for future management decisions. By coupling expanded access with more comprehensive and timely reporting, the EFPs provide an opportunity to evaluate whether state-based data collection can reduce uncertainty in recreational catch and effort estimates and provide managers with more reliable information than is currently available.
The proposed EFPs also provide an opportunity to demonstrate how cooperative federalism can improve both conservation and access. The states would operate within specified harvest limits and monitoring requirements, with provisions to close the fishery when those limits are projected to be reached. This approach recognizes that sustainable fisheries management and increased recreational fishing opportunity are not mutually exclusive when management decisions are supported by credible, timely data. As demonstrated by the progress made through enhanced state-level data collection in the Gulf, giving states a greater role in collecting and applying fishery data can reduce uncertainty while strengthening confidence in management decisions affecting anglers and coastal communities. The proposed EFPs represent a responsible opportunity to supplement existing federal data systems with state-based approaches that can be tested, evaluated, and improved. Recreational fishing is a cornerstone of our coastal economies and outdoor heritage. We believe these EFPs provide an important opportunity to test innovative management strategies grounded in sound science, accountability, and cooperative federalism. We respectfully encourage NMFS to approve the Florida, Georgia, and South Carolina EFP applications and allow these states to demonstrate how improved recreational data can lead to better fisheries management and greater confidence in the decisions that affect our anglers and coastal communities. Thank you for your consideration and for your continued work to ensure sustainable fisheries and meaningful recreational fishing opportunities for current and future generations.
Sincerely,
Senator Jim Boyd
Florida Legislative Sportsmen's Caucus Co-Chair
Senator Jason Brodeur
Florida Legislative Sportsmen's Caucus Co-Chair
Representative Danny Alvarez
Florida Legislative Sportsmen's Caucus Co-Chair
Senator Lee Anderson
Georgia Legislative Sportsmen's Caucus Co-Chair
Senator Sheikh Rahman
Georgia Legislative Sportsmen's Caucus Co-Chair
Representative Chas Cannon
Georgia Legislative Sportsmen's Caucus Co-Chair
National Assembly of Sportsmen's Caucuses Executive Council Member
Representative Matt Dubnik
Georgia Legislative Sportsmen's Caucus Co-Chair
Senator Stephen Goldfinch
South Carolina Legislative Sportsmen's Caucus Co-Chair
Senator Russell Ott
South Carolina Legislative Sportsmen's Caucus Co-Chair
National Assembly of Sportsmen's Caucuses Executive Council Member
Representative Heather Bauer
South Carolina Legislative Sportsmen's Caucus Co-Chair
Representative Gary Brewer
South Carolina Legislative Sportsmen's Caucus Co-Chair
*
Original text of letter here: https://www.regulations.gov/comment/NOAA-NMFS-2026-2245-3578
August 17, 2026
Mr. Andy Strelcheck
Southeast Regional Office
National Marine Fisheries Service
263 13th Avenue South
St. Petersburg, FL 33701.
Re: Exempted Fishing Permit Applications in the South Atlantic
Position: Support
Dear Mr. Strelcheck,
As leaders of the state legislative sportsmen's caucuses in Florida, Georgia, and South Carolina, we write to express our strong support for the new Exempted Fishing Permit ... Show Full Article WASHINGTON, Aug. 19 -- In response to a federal agency request for information, the following public comment letter was submitted electronically to the regulations.gov site. August 17, 2026 Mr. Andy Strelcheck Southeast Regional Office National Marine Fisheries Service 263 13th Avenue South St. Petersburg, FL 33701. Re: Exempted Fishing Permit Applications in the South Atlantic Position: Support Dear Mr. Strelcheck, As leaders of the state legislative sportsmen's caucuses in Florida, Georgia, and South Carolina, we write to express our strong support for the new Exempted Fishing Permit(EFP) applications submitted by our respective state fish and wildlife agencies concerning the recreational red snapper fishery in the South Atlantic. We appreciate the National Marine Fisheries Service's continued consideration of innovative, state-driven approaches that can improve recreational fisheries data collection, strengthen conservation, and provide anglers with meaningful fishing opportunities. The EFP applications submitted by the Florida Fish and Wildlife Conservation Commission, Georgia Department of Natural Resources, and South Carolina Department of Natural Resources represent a constructive partnership between state and federal fishery managers. The proposals would allow our states to pilot extended recreational red snapper fishing opportunities while implementing enhanced state-based data collection and reporting programs. Florida would build upon its State Reef Fish Survey while testing voluntary electronic reporting, while Georgia and South Carolina would utilize mandatory electronic reporting to collect timely, trip-level information on fishing effort, harvest, and releases. Importantly, these proposals are designed to test management approaches that can produce better information for future management decisions. By coupling expanded access with more comprehensive and timely reporting, the EFPs provide an opportunity to evaluate whether state-based data collection can reduce uncertainty in recreational catch and effort estimates and provide managers with more reliable information than is currently available.
The proposed EFPs also provide an opportunity to demonstrate how cooperative federalism can improve both conservation and access. The states would operate within specified harvest limits and monitoring requirements, with provisions to close the fishery when those limits are projected to be reached. This approach recognizes that sustainable fisheries management and increased recreational fishing opportunity are not mutually exclusive when management decisions are supported by credible, timely data. As demonstrated by the progress made through enhanced state-level data collection in the Gulf, giving states a greater role in collecting and applying fishery data can reduce uncertainty while strengthening confidence in management decisions affecting anglers and coastal communities. The proposed EFPs represent a responsible opportunity to supplement existing federal data systems with state-based approaches that can be tested, evaluated, and improved. Recreational fishing is a cornerstone of our coastal economies and outdoor heritage. We believe these EFPs provide an important opportunity to test innovative management strategies grounded in sound science, accountability, and cooperative federalism. We respectfully encourage NMFS to approve the Florida, Georgia, and South Carolina EFP applications and allow these states to demonstrate how improved recreational data can lead to better fisheries management and greater confidence in the decisions that affect our anglers and coastal communities. Thank you for your consideration and for your continued work to ensure sustainable fisheries and meaningful recreational fishing opportunities for current and future generations.
Sincerely,
Senator Jim Boyd
Florida Legislative Sportsmen's Caucus Co-Chair
Senator Jason Brodeur
Florida Legislative Sportsmen's Caucus Co-Chair
Representative Danny Alvarez
Florida Legislative Sportsmen's Caucus Co-Chair
Senator Lee Anderson
Georgia Legislative Sportsmen's Caucus Co-Chair
Senator Sheikh Rahman
Georgia Legislative Sportsmen's Caucus Co-Chair
Representative Chas Cannon
Georgia Legislative Sportsmen's Caucus Co-Chair
National Assembly of Sportsmen's Caucuses Executive Council Member
Representative Matt Dubnik
Georgia Legislative Sportsmen's Caucus Co-Chair
Senator Stephen Goldfinch
South Carolina Legislative Sportsmen's Caucus Co-Chair
Senator Russell Ott
South Carolina Legislative Sportsmen's Caucus Co-Chair
National Assembly of Sportsmen's Caucuses Executive Council Member
Representative Heather Bauer
South Carolina Legislative Sportsmen's Caucus Co-Chair
Representative Gary Brewer
South Carolina Legislative Sportsmen's Caucus Co-Chair
*
Original text of letter here: https://www.regulations.gov/comment/NOAA-NMFS-2026-2245-3578