Submitted Comments

Items Related to LCDs

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

November 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,

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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