Submitted Comments

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 FDA leadership reiterating our concerns with the proposed reclassification and elevating our request for withdrawal. 

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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)."

• real-world evidence
• real-world data

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The Alliance signed on to a letter with the American Diabetes Association, American College of Cardiology, Society for Cardiovascular Angiography & Interventions and others, requesting that CMS create a national coverage determination (NCD) for peripheral artery disease (PAD) screening and recommended follow-up testing for at-risk Medicare beneficiaries as part of efforts to identify, prevent, and mitigate diabetes-related complications and amputations. 

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The Alliance joined with 100+ healthcare provider organizations urging Congress to take immediate action to reverse the current 2.8% Medicare Physician Fee Schedule Conversion Factor (CF) reduction now in effect and provide clinicians with a positive payment update in the upcoming March 2025 appropriations bill. "The ongoing downward reimbursement spiral is contributing to consolidation in the health care system as more clinicians are no longer able to sustain their practices," the coalition of provider groups told Congress, advocating for inclusion of the bipartisan Medicare Patient Access and Practice Stabilization Act (H.R. 879) in the March package. H.R. 879 is designed to safeguard the financial stability of physician practices with provisions that protect clinicians from the 2.8% Medicare payment cut and a 2% inflation update to help offset rising costs and strengthen the sustainability of practices across the country.

**Action opportunity: Clinicians - send your own letter of support for H.R. 879 via several Alliance members' "Voter Voice" Action Centers where you can adapt from their letter template and send to your state Congressional delegation at the touch of a button. See Action Centers from the American Physical Therapy Association, Academy of Nutrition and Dietetics and Society for Vascular Surgery. 

Read Co-Signed Letter to Congress

The Alliance submitted comments to CMS' Medicare Managed Care proposed rule supporting the Agency's provisions to improve Prior Authorization processes, while encouraging additional provisions to ensure MCO accountability are still needed. Only when payers are held accountable will the proposed changes to PA be a success for health care providers and the beneficiaries they are treating.

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The Alliance submitted comments to CMS and the Partnership for Quality Measurement’s Pre-Rulemaking Measure Review Committee reiterating that we do not support the Non-Pressure Ulcers Episode-Based Cost Measure as currently proposed. The letter again articulated our many concerns – which were previously raised in prior comment letters, in meetings with Acumen staff, and most recently as part of our oral statement at the December Pre-Rulemaking Measure Review (PRMR) Listening Session. The Alliance recommended that the measure be withdrawn until further refinements are made and additional testing can be conducted with results provided to the Clinical Expert Workgroup for further discussion.

• nonpressure ulcer cost measure

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The Alliance, in collaboration with Epstein Becker Green, submitted a letter to CMS seeking important clarification on the 2025 Medicare Physician Fee Schedule Final Rule provisions setting a national reimbursement rate for autologous blood-derived products. The letter posed questions regarding billing for autologous blood-derived products (HCPCS code G0465) when multiple wounds are being treated, or when a wound with a large surface area requires more than one application of an autologous blood-derived product to treat the wound. The Alliance offered suggestions for N Medicare Learning Network (“MLN”) Matters article AND updates to the Medicare billing guidance for G0465 to better clarify for providers how multiple applications of an autologous blood-derived product should be appropriately identified on the CMS-1500 claim form and how Medicare payment will be made for such multiple applications.

• blood-derived products

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The Alliance submitted a letter to the DMEMAC medical directors elevating procedural concerns, potential improper voting processes, and technical delays that resulted in inadequate time for meaningful discussion of new evidence at the December Carrier Advisory Committee (CAC) meeting convened to discuss requests to revise the Oxygen and Oxygen Equipment Local Coverage Determination (LCD) to include language that Topical Oxygen is reasonable and necessary for wound healing therapy for treating Diabetic Foot Ulcers.

• topical oxygen

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The Alliance presented at the Pre-Rulemaking Measure Review (PRMR) 2024 Measures Under Consideration Clinician Measures Listening Session, reiterating to Acumen and its expert panel that the Alliance does not support the Non-Pressure Ulcers Episode-Based Cost Measure as it is currently written. Similar to our prior letter to Acumen, our statement at the December 17th meeting flagged specific concerns with Acumen’s field testing of the current measure, including: an attribution methodology that incorrectly attributes costs; errors in diagnosis codes and ulcer categories that resulted in the cost for each ulcer category to be incorrectly calculated; and dramatic variations and discrepancies in calculations with no explanations provided. The methodology is so fatally flawed, we emphasized to Acumen in our statement, that the cost measure should not be utilized as it will not only be unsuccessful - it will be detrimental to clinicians.

• nonpressure ulcer cost measure

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The Alliance delivered oral testimony at the Dec. 10 Multi-MAC Town Hall Meeting and listening session on the final local coverage policies on CTPs for the treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. The Alliance posed several specific questions regarding scenarios for multiple wounds as well as number of applications, as well as pursued clarification of reconsideration timelines and processes for manufacturers to submit new evidence for coverage.

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