Submitted Comments

Items Related to LCDs

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.
November 19, 2024

Final CTP/Skin Substitute LCDs Reflect Stakeholder Input, Provide Treatment Flexibility, but Lack Clarity on Timely Process for Future Evidence Submissions for Coverage

Statement from the Alliance of Wound Care Stakeholders

Nov. 19, 2024 – The Alliance of Wound Care Stakeholders is pleased that CMS’ Medicare Administrative Contractors (MACs) carefully considered stakeholder recommendations and made substantive changes following input from the wound care community in the recently released final Local Coverage Determinations (LCDs) and accompanying Coding and Billing Articles, “Skin Substitute Grafts/Cellular and Tissue-Based Products (CTPs) for the Treatment of Diabetic Foot Ulcers & Venous Leg Ulcers.” With publication of the final policy by each MAC, the wound care community now has clearer understanding of Medicare coverage for the application of CTP/skin substitute products in treating diabetic foot ulcers (DFU) and venous leg ulcers (VLU). The Alliance and the larger wound care clinical community mobilized together, illustrating the power of tenacious advocacy and a unified voice to positively influence policies so that they reflect quality wound care practice. In a noted change that was in direct alignment with Alliance recommendations, the MACs increased the covered application limit from 4 to 8 in the final policy, now consistent with the supportive clinical evidence, treatment guidelines and current standard of care to promote wound healing. Similarly the "episode of care" treatment duration increased from 12 to 16 weeks.

The Alliance believes these are considerable improvements to the concerning limitations that had been included in the proposed policies issued for comment this past April. Under the finalized LCDs, providers have the application flexibility (supported by sufficient documentation) needed for wound healing and, importantly, Medicare beneficiaries with hard-to-heal DFUs/VLUs can benefit from improved outcomes. Still, additional clarity is needed...

September 28, 2023

Medicare Administrative Contractors Withdraw LCDs/LCAs that Disrupted Care, Dramatically Restricted Access to CTPs (Skin Substitutes)

Following tenacious collaborative advocacy from the Alliance of Wound Care Stakeholders and across the wound care community, three Medicare Administrative Contractors – Novitas, First Coast Service Options, and CGS Administrators – today withdrew their local coverage determinations (LCDs) and local coverage articles (LCAs) that that would have dramatically restricted Medicare patients’ access to cellular and tissue-based products for wounds (CTPs, or "skin substitutes”), advanced wound care treatments that are instrumental to wound healing. The policies were scheduled to go into effect on Oct. 1st but have now been pulled. “This was a collaborative effort across the wound care community and, with the withdrawal of the policies, our advocacy clearly had impact. The real winners here are Medicare beneficiaries with chronic wounds who now won’t face disruptions to care or unnecessary restrictions to treatments that can support wound healing,” said Marcia Nusgart, R.Ph., CEO of the Alliance. 

SEE NEWS RELEASE
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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