MACs to issue final LCDs for skin substitute products effective Jan. 1, 2026
By HME News Staff
Updated 8:27 AM CST, Wed December 17, 2025
WASHINGTON – The seven A/B Medicare Administrative Contractors (MACs) will release updated final Local Coverage Determinations (LCDs) for skin substitute grafts and cellular/tissue-based products used to treat diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) that will be effective Jan. 1, 2026, according to a Dec. 15 Fact Sheet from the Centers for Medicare & Medicaid Services (CMS).
Key highlights of the LCDs
- Expanded access: Medicare beneficiaries with DFUs and VLUs will have access to multiple evidence-based skin substitute products.
- Scope: LCDs apply only to DFU and VLU indications; they do not affect payment for other uses.
- Utilization controls: Frequency and usage limits are included to promote patient safety and ensure reasonable use.
Background and process
- CMS delayed the original LCD effective date under the Trump Administration to allow for a comprehensive review and stakeholder input.
- A six-month evidence submission period ended Nov. 1, 2025, with CMS receiving data for 66 products.
- Products were categorized into three groups:
- Covered: Products meeting evidence standards; covered starting Jan. 1, 2026.
- Non-covered: Products lacking sufficient evidence or ongoing research.
- 12-month status quo: Products with interim results or active clinical trials; MACs may pay claims at their discretion during this period.
At the end of the 12-month status quo period (Dec. 31, 2026), MACs will reconsider coverage based on new evidence. A revised LCD is expected in early 2027.
Current coverage snapshot
- 18 products identified as covered (including one with new 2025 research).
- 154 products fall under MAC discretion during the status quo period.
Additional resources
- https://www.cms.gov/cms-guide-medical-technology-companies-and-other-interested-parties/coverage/local-coverage-determination-process-and-timeline
- https://www.cms.gov/newsroom/press-releases/cms-modernizes-payment-accuracy-significantly-cuts-spending-waste
- https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2026-medicare-physician-fee-schedule-final-rule-cms-1832-f
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