Submitted Comments
September 15, 2025
The Alliance submitted comprehensive comments to CMS’ proposed CY 2026 Hospital Outpatient Prospective Payment System (CMS-1834-P). Alliance feedback and recommendations focused on a range of provisions impacting wound care, including:
- Cellular and/or Tissue based Products for Skin Wounds (CTPs): The Alliance supported CMS’ proposal to pay for CTPs separately, without bundling or packaging, as the unbundling will now enable hospital outpatient departments to be reimbursed for CTP product for larger wounds as well as received equalized payment for the application of CTPs on wounds/ulcers regardless of anatomic location. Comments addressed these issues as well as CMS' related proposals on “incident to supplies” payment methodology and creation of new reimbursement categories for CTPs based on FDA regulatory categories.
- Blood and Blood Derived Products: The Alliance supported continued payment of Blood and Blood Derived Products separately rather than being packaged.
- Point of Care Imaging (POCI): Alliance responded to CMS’ request for feedback on its Software as a Service (SaaS) approach, recommending that POCI solutions for wound care be considered in future SaaS reimbursement frameworks. CMS should develop specific billing codes (e.g., for image capture, interpretation, and care planning) for approved wound care imaging tools, the Alliance recommended.
- Therapeutic Shoes for Patients with Diabetes: Highlighting easily correctable barriers that delay care, the Alliance recommended that CMS update burdensome requirements in Medicare’s Therapeutic Shoe Program for Patients with Diabetes.
- Total Contact Casting (TCC): The Alliance asked CMS to fix current inconsistencies in National Correct Coding Initiative policies that make it difficult for hospital outpatient departments to get paid separately for TCC when provided on the same date of service as a debridement or CTP application.
September 12, 2025
The Alliance submitted comprehensive comments to CMS’ proposed CY 2026 Medicare Physician Fee Schedule (CMS-1832-P). Alliance feedback and recommendations focused on a range of provisions impacting wound care, including:
- Efficiency Adjustment: The Alliance does not support the proposed 2.5% efficiency adjustment and recommended that the Agency withdraw this proposal. "The across-the-board proposed adjustment across thousands of codes overlooks the wide variation among services – which is problematic and negatively impacts those performing them," the Alliance wrote.
- Cellular and/or Tissue based Products for Skin Wounds (CTPs): While the Alliance does not agree that CTPs are “supplies,” it does support CMS’ proposal to pay for CTPs separately, without bundling or packaging, creating site neutral payment under both the PFS and the Hospital Outpatient Prospective Payment System. “Separate payment for these products appropriately recognizes these products’ distinct value in improving wound care outcomes for patients, enhances access to care, and promotes clinically appropriate site-of-service decisions,” the Alliance wrote. The Alliance emphasized that the Agency's proposed 2026 “incident-to supplies” payment rate of approximately $125.38 per sq. cm. is too low, and proposed alternatives. Comments addressed many additional details of the new payment methodology as well as CMS' proposed creation of reimbursement categories for CTPs based on FDA regulatory categories versus a single reimbursement rate.
- Blood and Blood Derived Products: The Alliance voiced ongoing support for the national payment rate blood-derived products set last year, but sought updates to enable full payment for application of these products to multiple wounds.
- Hyperbaric Oxygen Therapy: The Alliance recommended that CMS maintain the use of the current coding methodology (codes 99183 and G0277) in 2026 to ensure continuity of care, proper reimbursement and alignment with the clinical realities of hyperbaric medicine.
- Point of Care Imaging (POCI): Alliance noted the value of POCI platforms in wound care and recommended that POCI solutions be considered in any future Software as a Service (SaaS) reimbursement frameworks. As POCI tools are often underutilized because their use is not explicitly reimbursed, CMS should develop specific billing codes (e.g., for image capture, interpretation, and care planning) for approved wound care imaging tools, the Alliance recommended.
- Therapeutic Shoes for Patients with Diabetes: Highlighting easily correctable barriers that delay care, the Alliance recommended that CMS update burdensome requirements in Medicare’s Therapeutic Shoe Program for Patients with Diabetes.
August 27, 2025
The Alliance submitted comments to CMS's proposed CY 2026 Home Health Prospective Payment System Rate Update, with a focus on provisions related to home health payment reductions, face-to-face supervision changes, lymphedema compression coding and payment, and issues related to the proposed reintroduction of the Competitive Bidding Program.
July 22, 2025
The Alliance submitted a letter of support for Massachusetts State House Bill 2407 / Senate Bill 1542, “An Act Relative to the Definition of Podiatry,” that would update and modernize the podiatric scope of practice law in Massachusetts to allow podiatrists to treat the foot, ankle, and lower leg.
July 14, 2025
HHS issued a Request for Information in May soliciting recommendations on specific regulations that should be eliminated "to lower healthcare costs, reduce burdens on physicians, and address the prevalence of chronic disease." The Alliance engaged its multiple workgroups to identify specific areas for inclusion and submitted to HHS a detailed chart of regulations with corresponding recommendations across specific guidance. These included recommendations to:
- Correct several problematic NCCI edits including Total Contact Cast (TCC)
- Revise Coverage w Evidence Development (CED) processes and the Transitional Coverage for Emerging Technologies (TCET) pathways – as they are cumbersome and do not achieve the desired results of bringing product to market faster.
- Remove burdens to the Medicare process for obtaining therapeutic shoes for patients with diabetes that currently creates unnecessary delays in care.
- Issue clear, enforceable guidance to Medicare Advantage Programs requiring that their coverage and documentation requirements align with, and are no more restrictive than, those established under Medicare Fee-for-Service (FFS) as is required in regulation.
- Update provisions for lymphedema compression treatment coverage to enable payment for clinicians to measure and fit lymphedema compression garments, and more...
July 1, 2025
The Alliance submitted comments to the National Quality Forum (NQF) request for stakeholder input on its proposed updates to its Serious Reportable Events (SRE) List. The Alliance focused on a problematic update to SRE 15: "Patient Harm Associated With a Stage 3 Pressure Injury, Stage 4 Pressure Injury, or Deep Tissue Injury Acquired After Admission." The 2025 update identifies 27 areas as serious reportable events and expands all SREs to all healthcare settings. The Alliance recommended not only that SRE 15 “not be expanded to other healthcare settings since it is totally different and unique from others that are currently on the list” but also that it be removed from the list entirely. “Pressure ulcers/pressure injuries can be a normal physiologic response to the underlying co-morbid illnesses and acute hemodynamic factors and are not in the same category as operating on the wrong patient or wrong site, an overdose of radiotherapy, or insemination with the wrong sperm -- events that are clearly identifiable to a provider.” If NQF is not willing to delete SRE 15 from the 2025 list, the Alliance recommended that it limit the healthcare settings to only hospital/acute care and eliminate ambulatory/outpatient, post-hospital/subacute and home care. “Given the delay from event to presentation of a pressure ulcer/pressure injury, it will be impossible to reliably link them to an outpatient healthcare encounter,” the Alliance wrote.
June 16, 2025
The Alliance submitted comments in response to CMS' request for information (RFI) seeking input regarding the market of digital health products for Medicare beneficiaries as well as the state of data interoperability and broader health technology infrastructure. "The demand and dependencies on timely and high-quality electronic health information across the health care and technology innovation ecosystems have grown, and actors are not being held accountable for blocking or inhibiting the flow of patient data," the Alliance wrote in comments that highlighted the necessity to address specific gaps and challenges and submitted a number of detailed recommendations and suggestions for the Agency to consider.
May 12, 2025
.The Alliance submitted comments to the Office of Management and Budget responding to its request for feedback on opportunities for deregulation. The Alliance provided suggestions for deregulation as well as recommendations to streamline or correct current regulatory and sub-regulatory provisions. These suggestions included:
- Withdrawal of FDA Proposed Rule re: Reclassification of Certain Antimicrobial Wound Dressings
- Changes to Prior Authorization processes
- Lessening of burdens within Medicare’s Therapeutic Shoe Program for Patients with Diabetes
- Fixes to problematic payment provisions for CTPs in the Hospital Outpatient Prospective Payment System
- Expanded adoption of real-world evidence (RWE) and updates to Coverage with Evidence Development
- National Correct Coding Initiative; Audit Reform; Data & Reporting Processes that are Duplicative or Overly Complex; plus additional opportunities for deregulation and reform...
April 18, 2025
When the FDA last year released a proposed rule and companion amendments on classification of certain antimicrobial wound dressings, the Alliance flagged to the Agency the many gaps and ambiguities in the policy, the reduced availability of wound dressing products that could result if it is implemented, and the harm this could cause to patient care. Our submitted comments at that time urged FDA to withdraw the policy for further vetting. Following the late-March 2025 confirmation of a new FDA Commissioner, the Alliance opted to send a letter to the FDA Commissioner and to the Office of Management & Budget Director reiterating our concerns with the proposed reclassification and elevating our request for withdrawal.
March 17, 2025
The Alliance submitted comments to CMS' Proposed Guidance Document: Study Protocols That Use Real-world Data (RWD) urging that use of RWD for real-world evidence (RWE) be extended to all coverage determinations, not just to the national coverage determination (NCD) coverage with evidence development (CED) process as proposed. "Using RWE only for NCDs with CED is rather limiting as there are very few NCDs based on CED. If the Agency is permitting RWE to be used for coverage purposes, the use should be extended to all coverage determinations," the Alliance advocated to CMS, submitting the recommendation that "any coverage policy should consider RWE as an adjunct to Level 1/Level 2 evidence when determining product coverage since it aligns with the Congressional intent of the 21st Century Cures Act in 2016 encouraging the use and acceptance of RWE. Therefore any guidance offered in terms of appropriate evidentiary standards including the use of RWE should apply not only to NCDs based on CED or NCDs in general but also to Local Coverage Determinations (LCDs)."
