Submitted Comments

The work relative value units (“RVUs”) assigned for HCPCS code G0465 do not accurately reflect the time, intensity, mental effort and judgment, technical skill and physical effort associated with the delivery of autologous platelet rich plasma (“PRP”) or other blood-derived products for the treatment of chronic, non-healing diabetic wounds, the Alliance told CMS in a letter requesting that the code be considered - and the work RVUs updated - under the "Potentially Misvalued Code" process. The Alliance also asked CMS to clarify its billing and reimbursement policies for multiple applications of an autologous blood-derived product when used to treat a large surface area wound and/or to treat multiple wounds on the same date of service. "Multiple product kits may be needed... [and] requiring that an additional application of autologous blood-derived product be subject to a 50 percent reduction in reimbursement for the code means that the cost of the product is not covered. Accordingly, clinicians are not able to furnish multiple applications of autologous blood-derived product on the same date of service in the physician office setting, even when it is medically necessary and appropriate to do so." The end result: "Patients with multiple wounds or wounds with large surface areas either need to be treated on separate days or in the hospital outpatient setting, which creates a disparity in access and leads to increased Medicare costs for patients who could have otherwise been treated safely and effectively in the physician office setting on the same day," the Alliance wrote.

• blood-derived products

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The Alliance submitted its wound care perspective to CMS' Proposed Policy and Technical Changes to the Medicare Advantage Program  for Contract Year 2027. The Alliance raised concerns regarding how modifications to the Hierarchical Condition Category risk adjustment model could impact for beneficiaries requiring wound care services. Comments also flagged that Medicare Advantage (MA) enrollees with lymphedema are not consistently receiving the coverage to which they are entitled, despite statutory requirements mandating that MA plans provide benefits that are at minimum equivalent to those available under traditional Fee-for-Service Medicare. "Analysis of coverage policies, beneficiary reports, and plan documents across multiple MA plans demonstrates that coverage for lymphedema compression treatment items varies dramatically from plan to plan...Some MA plans have implemented coverage policies that closely mirror FFS Medicare standards, while others have erected substantial barriers that effectively limit beneficiary access to appropriate lymphedema management supplies," the Alliance reported, urging updates.

• lymphedema

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The Alliance provided its wound care perspective in response to the FDA's Request For Public Comment: Measuring and Evaluating Artificial Intelligence-enabled Medical Device Performance in the Real-World. The Alliance addressed both the transformative benefits of AI in wound care like automating wound image segmentation, measuring wound area and depth, and predicting healing trajectories, but emphasized that AI technologies should support and aid clinical decision-making, not replace it. Clinicians provide contextual interpretation, ensure outputs are clinically meaningful, and manage ambiguous scenarios that fall outside an algorithm’s learned patterns. Clinician review also serves as a critical safeguard for ethical decision-making and patient safety, the Alliance wrote, noting that the most effective real-world workflows should integrate both modalities. Read the Alliance's specific responses to questions posed by FDA in the comments below (accessible with member login). 

• FDA

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Together with the Academy of Nutrition and Dietetics, the American Diabetes Association and 14 other organizations, the Alliance co-signed a letter to Congress urging legislators to work quickly and collaboratively to resolve the current funding impasse and restore access to vital health programs - such as WIC, SNAP, telehealth services and more - that protect the health and well-being of communities and safeguard health outcomes nationwide.

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The Alliance urged the U.S. Department of Commerce to "carefully weigh the real-world consequences" of its recently published Section 232 National Security Investigation into the importation of medical devices and equipment, medical consumables and personal protective equipment. "Section 232 is designed to protect national security interests. In the context of medical imports, however, this approach can have the unintended consequence of compromising public health...Wound care is time sensitive and resource intensive. The successful treatment of complex wounds often relies on advanced dressings, biologics, and other specialized products, many of which are sourced globally. Limiting access to these materials through tariffs or import restrictions would directly jeopardize patient outcomes and strain already overburdened clinical system," the Alliance wrote, recommending exclusion of medical equipment, supplies and devices from any Section 232 actions. 

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The Alliance submitted comprehensive comments to CMS’ proposed CY 2026 Hospital Outpatient Prospective Payment System (CMS-1834-P) focused on a range of provisions impacting wound care, including:

• CTPs: The Alliance commended CMS efforts to improve program integrity in the reimbursement of CTPs. The Alliance has advocated over the years for CMS to fix flaws and inadequacies in the OPPS bundled payment methodology and applauds the Agency’s current efforts to do so. The Alliance supports CMS’ proposal to pay for CTPs separately, as unbundling will finally enable hospital outpatient departments to be reimbursed for CTP products for larger wounds as well as receive equalized payment for the application of CTPs regardless of a wound’s anatomic location – fixes that the Alliance has elevated to CMS for years. Comments addressed details of CMS’s proposed “incident to supplies” payment methodology and the creation of new reimbursement categories for CTPs based on FDA regulatory categories versus a single payment approach.
• Blood and Blood Derived Products payment
• Point of Care Imaging (POCI) reimbursement under  Software as a Service (SaaS) frameworks
• Total Contact Casting (TCC) coding and payment policy clarification/correction
• Therapeutic Shoes for Patients with Diabetes access barriers
• Price Transparency

• CMS
• CTPs/(skin substitutes)
• Physician Fee Schedules
• HOPPS
• blood-derived products

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The Alliance submitted comprehensive comments to CMS’ proposed CY 2026 Medicare Physician Fee Schedule (CMS-1832-P) focused on a range of provisions impacting wound care. The Alliance agreed with CMS that the current utilization and reimbursement for CTPs (skin substitutes) in the physician office setting has led to a significant and unsustainable growth in spending and there is a need to “limit some of the current profiteering practices occurring.” The Alliance applauded CMS for addressing this issue that has been plaguing the industry for several years. The current methodology has created perverse incentives that resulted in explosive growth in spending, with little to no correlation to improved outcomes. While the Alliance does not agree that CTPs are “supplies,” we do support CMS’ proposal to pay for CTPs separately as "incident-to-supplies" without bundling or packaging, creating site neutral payment under both the PFS and OPPS. “Separate payment appropriately recognizes these products’ distinct value in improving outcomes for patients, enhances access, and promotes clinically appropriate site-of-service decisions,” the Alliance wrote. Comments requested an increase to the proposed 2026 payment rate and provided inputs on the new payment methodology and proposed creation of reimbursement levels for CTPs based on FDA regulatory categories.

Alliance comments to the Physician Fee Schedule also recommended:

• Efficiency Adjustment withdrawal
• Blood and Blood Derived Products payment adjustment
• Hyperbaric Oxygen Therapy coding methodology
• Point of Care Imaging (POCI) reimbursement under Software as a Service (SaaS) frameworks
• Therapeutic Shoes for Diabetic Patients access improvements

• CMS
• CTPs/(skin substitutes)
• Physician Fee Schedules

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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.

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