Submitted Comments

Items Related to Medicare Administrative Contractors (MACs)

November 22, 2025

Alliance Statement on Final 2026 Medicare Physician Fee Schedule & Hospital Outpatient PPS

Wound Care Advocacy Wins: Separate, Site Neutral Payments for CTPs/Skin Substitutes Remove Access Barriers in Hospital Outpatient Setting; Combat Waste/Fraud/Abuse that has Led to Unsustainable Medicare Spend in Physicians’ Office Setting.

November 2025 – The Alliance of Wound Care Stakeholders commends CMS on its initiatives in the final CY 2026 Medicare Physician Fee Schedule and Hospital Outpatient Prospective Payment System (HOPPS) to reform the payment system for cellular and tissue-based products for wounds (CTPs, or “skin substitutes”) in its efforts to combat fraud, waste and abuse of these products and address the excessive spending that has made the current payment methodology unsustainable. Following years of persistent advocacy with CMS policymakers, the Alliance believes the establishment of separate, site neutral payment in 2026 enables clinically appropriate site-of-service decisions – with particular impact in the hospital outpatient setting, where the current bundled payment methodology has challenged access and driven care to other sites of service. The Alliance has repeatedly addressed this issue to the Centers for Medicare and Medicaid Services in our comments which had already gained the endorsement of the Agency’s Advisory Panel on Hospital Outpatient Payment on policy fix recommendations. CMS had not acted on those recommendations until now. In an advocacy “win” for patients and providers alike, HOPDs will now be more able to provide CTPs to patients with larger wounds rather than shifting them to alternate sites of care.

Separate, Site Neutral Payment & “Win” for Access in the Hospital Outpatient Setting...

April 11, 2025

Delayed Implementation: "Effective date" for CTP LCDs postponed by CMS to January 2026

(April 11, 2025) The  “future effective date” of the local coverage determinations for use of CTPs (skin substitutes) in diabetic foot ulcer and venous leg ulcer have been delayed until January 1, 2026. (UPDATE: on 12/24/25 CMS announced withdrawal of the LCDs.)
January 25, 2025

Delayed Implementation: "Effective date" for CTP (skin substitutes) LCDs is now 4/13/25

1/25/25 - All of the Medicare Administrative Contractors (MACs) have delayed the effective date of the final local coverage determinations for cellular and tissue-based products for wounds (CTPs, or "skin substitutes") in diabetic foot ulcers and venous leg ulcers by 60 days, moving the implementation date across all MAC jurisdictions from 2/12/25 to 4/13/25. (NOTE: on 12/24/25 CMS announced withdrawal of the LCDs.)

May 16, 2024

Oral Testimony at MAC "Listening Sessions" on LCDs/LCAs for use of CTPs in DFU/VLU

The Alliance provided oral testimony at the open public feedback sessions that each Medicare Administrative Contractor (MAC) held to collect stakeholder input on the proposed LCD "Skin Substitute Grafts/Cellular & Tissue-Based Products for the Treatment of DFU and VLU.”  The Alliance voiced support for the proposed LCD language permitting additional applications beyond the 4 application limit and the extension of the 12-week treatment period based on medical necessity with documentation provided in the patients’ medical record. The Alliance also requested more transparency and consistency regarding the evidentiary bar being applied to determine if coverage will be provided - noting that there are a number published, peer-reviewed studies supporting a range of products that for unknown reasons were not included on the MACs’ list of evidence reviewed. Finally, the Allianced encouraged the MACs to ensure they provide enough time to implement the LCD, once finalized, so not to negatively impact patient care. The comments below were delivered to: CGS Administrators (5/16/2024); First Coast Service Options (5/23/2024); National Government Services (5/16/2024); Noridian Healthcare Solutions (J-E on 5/16/2024; J-F on 5/16/2024); Novitas Solutions (5/24/2024); Palmetto GBA (5/29/2024) and WPS Insurance Corporation (5/22/2024). More detailed written comments will be submitted by the June 8 submission deadline. 
August 25, 2022

Oral Testimony on FCSO/Novitas Public Meetings on Draft LCD/LCA for Skin Substitutes for the Treatment of DFU/VLU

The Alliance made its voice heard to First Coast Service Option and Novitas by providing oral testimony at the Medicare Administrative Contractors' public meetings to collect stakeholder input on their draft LCDsand LCAson Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. One of 15 presenters specifically providing oral comments on these policies, the Alliance reiterated recommendations expressed in its April comments and May comments, and questioned why no inputs had been addressed. "If First Coast and Novitas were interested in further comments, then releasing a draft policy taking into consideration our already provided comments would have been a more useful exercise," the Alliance said, reminding the MACS of the key focus of our previously submitted comments: Many of the statements and limitations in the policy do not have the scientific evidence to support them, arbitrary utilization parameters, and clinically incorrect information in the policies

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