Submitted Comments

Items Related to Medicare Administrative Contractors (MACs)

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. Today's announcement from CMS states: "As part of the transition to a new Administration, CMS is reviewing its coverage policies for skin substitute products. CMS believes it is important to maintain patient access to skin substitute products with high quality evidence of effectiveness. Because of this review, the Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers Final Local Coverage Determinations effective date will be delayed until January 1, 2026. The Agency requests that any peer-reviewed publications and high-quality findings from other public sources of skin substitute study results be submitted to CMS at This email address is being protected from spambots. You need JavaScript enabled to view it. by November 1, 2025. CMS will ensure all evidence received will be sent to the MACs to review to determine if revisions to the LCD are appropriate."

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.

As there were seismic changes to the number of covered products, allowable applications, and required documentation in the final LCDs published in November 2024, wound care providers across the country who treat DFU/VLU in Medicare beneficiaries have been preparing for the original February 12, 2025 implementation date. This 60 day postponement to April 13th has the upside of providing additional preparation time. See the "Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers & Venous Leg Ulcers" LCDs from each MAC below.

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