MACs withdraw new coverage policies for skin substitutes
By HME News Staff
Updated 9:55 AM CST, Mon December 29, 2025
WASHINGTON – The A/B Medicare Administrative Contractors (MACs) are withdrawing the 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 were scheduled to go into effect Jan. 1, 2026.
The Centers for Medicare & Medicaid Services (CMS) made the announcement on Dec. 24, only days after announcing that the MACs would release updated LCDs that would go into effect Jan. 1, 2026.
The only other information provided by CMS:
- 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.
In calendar year 2026, CMS plans to finalize payment for skin substitute products as incident-to supplies when they are used as part of a covered application procedure paid under the physician fee schedule in the non-facility setting or under the Medicare Hospital Outpatient Prospective Payment System in the hospital outpatient department setting,
The agency also plans to finalize the alignment of skin substitute categorization consistent with their U.S. Food and Drug Administration (FDA) regulatory status, such as 361 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) and the device types: pre-market approvals (PMAs) and 510(k)s.
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