MACs to Update Final LCDs for Skin Substitutes in the US
The Centers for Medicare and Medicaid Services released information today on updates to the final LCDs for Skin Substitutes due to take effect on January 1, 2026.
Key Summary
- Medicare LCDs for skin substitute grafts/CTPs will take effect January 1, 2026, governing coverage for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). All local MACs are set to issue updates to the LCDs in advance of that date.
- Products are categorized by evidence levels into covered, non-covered, and a 12-month “status quo” group.
- Review of submitted clinical evidence will inform early-2027 LCD reconsideration; discretion remains for MACs to adjudicate claims.
Main News
December 12, 2025 - The Centers for Medicare & Medicaid Services (CMS) today released an updated fact sheet detailing upcoming changes to Final Local Coverage Determinations (LCDs) for skin substitute grafts and cellular and tissue-based products used in treating DFUs and VLUs. The nationwide policies, soon to be finalized by all seven Medicare Administrative Contractors (MACs), will be effective January 1, 2026.1
The updated LCDs will specify coverage frameworks for multiple evidence-based skin substitute products for Medicare beneficiaries with chronic wounds. Covered products meet the LCD’s evidence thresholds demonstrating reasonable and necessary clinical benefit, while non-covered products lack sufficient supporting data as of the Nov 1, 2025 submission deadline.1
A third category — the 12-month status quo period — applies to products with interim or ongoing research; these products do not yet have definitive coverage determinations but may be paid at MAC discretion, provided claims meet the usual “reasonable and necessary” criteria under the Social Security Act.1
CMS has scheduled a reconsideration of the LCDs in early 2027, during which additional evidence submitted through Dec 31, 2026 will be reviewed for possible updates to product coverage lists.1
Details and information on this new development are ongoing. Visit the CTP News Desk for more analysis and viewpoints as they develop.
Reference
- Centers for Medicare & Medicaid Services. Upcoming update to the final Local Coverage Determinations (LCDs) for certain skin substitutes. CMS.gov. Published December 15, 2025. Accessed December 15, 2025. https://www.cms.gov/newsroom/fact-sheets/upcoming-update-final-local-coverage-determinations-lcds-certain-skin-substitutes
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