Upcoming Update to the Final Local Coverage Determinations (LCDs) for Certain Skin Substitutes

Upcoming Update to the Final Local Coverage Determinations (LCDs) for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers

All seven of CMS' A/B Medicare Administrative Contractors (MACs) will issue updated Final Local Coverage Determinations (LCDs) for Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers that will be effective January 1, 2026.

The LCDs provide access to multiple evidence-based skin substitute products for Medicare beneficiaries with diabetic foot ulcers and venous leg ulcers. The LCDs only apply to these indications and do not impact payment of these products for other uses. They also describe important frequency and utilization limits that promote patient safety and reasonable use of these products.

Under the Trump Administration's leadership, the effective date of the original LCDs was delayed for CMS to review coverage policies for skin substitute products, and an additional six-month period was granted when stakeholders could submit high quality evidence of effectiveness for these products. CMS received evidence submissions for 66 skin substitute products by the November 1, 2025, deadline. Products were categorized into three groups:

• Coverage: Products meeting the evidence threshold outlined in the LCDs that will be covered by Medicare beginning January 1, 2026.
• Non-Covered: Products for which manufacturers have not to date submitted adequate evidence that their products meet the reasonable and necessary standard or identified any ongoing relevant research.
• 12-Month Status Quo Period: Products that have published interim results, published or submitted protocols, have an assigned clinical trial number, or demonstrated ongoing clinical trial or peer reviewed investigational research published between the posting date of the proposed LCDs and November 1, 2025.

The updated final LCDs do not establish a coverage policy for the products in the 12-month status quo category. As is always the case, a product with neither a positive or a negative LCD coverage determination must nevertheless meet the "reasonable and necessary" standard in section 1862(a)(1)(A) of the Social Security Act and any other applicable requirements in order to be paid. At the MACs' discretion, the products can be paid for (i.e. MACs will make individual claim determinations), while the product sponsors complete their studies. At the conclusion of the 12-month status quo period, the MACs will initiate a reconsideration of the LCDs, reviewing any evidence received by December 31, 2026. The MACs will also reconsider coverage for products non-covered under the LCDs if sponsors submit additional evidence that demonstrates that the product is reasonable and necessary for the Medicare population. The reconsideration of the LCDs is scheduled for release in early 2027.

This approach balances evidence-based coverage standards while recognizing manufacturers' good-faith efforts to meet clinical evidence standards for coverage and minimizes market disruption, while still distinguishing between products based on the quality of evidence submitted. The MACs will provide manufacturers with clear information about what health outcomes and research they expect to see in future submissions.

The MACs have identified 18 covered products including one product that submitted new research in 2025. During the 2025 evidence review period, the MACs determined that eight of the 66 evidence submissions for skin substitute products were reports of interventional randomized controlled trials (RCTs). Of those, Grafix Prime met the evidence threshold and was added to the covered group. Grafix Prime's RCT was published on April 16, 2025, along with corroborating evidence.

Table 1. List of Covered Products (18 Codes)

Table 2. List of MAC Discretion Products (154 Codes)

Table 3. List of Non-Covered Products (158 Codes)

For more information on the LCD process, see https://www.cms.gov/cms-guide-medical-technology-companies-and-other-interested-parties/coverage/local-coverage-determination-process-and-timeline.

For additional information on CMS's efforts to reduce Medicare spending waste for skin substitutes, see the following:

Press release, "CMS Modernizes Payment Accuracy and Significantly Cuts Spending Waste": https://www.cms.gov/newsroom/press-releases/cms-modernizes-payment-accuracy-significantly-cuts-spending-waste.

Fact Sheet, Calendar Year 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F): https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2026-medicare-physician-fee-schedule-final-rule-cms-1832-f.

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