The Centers for Medicare & Medicaid Services (CMS) has postponed the implementation of its final local coverage determination (LCD) for skin substitute grafts/cellular and tissue-based products until Jan. 1, 2026.
The LCD, for products used to treat diabetic foot ulcers and venous leg ulcers, had previously been scheduled to take effect on April 13, which itself was an extension from the original Feb. 12, 2025, effective date.
“As part of the transition to a new administration, CMS is reviewing its coverage policies for skin substitute products,” the agency said in an April 11 press release. “CMS believes it is important to maintain patient access to skin substitute products with high quality evidence of effectiveness. … The agency requests that any peer-reviewed publications and high-quality findings from other public sources of skin substitute study results be submitted to CMS at [email protected] by Nov. 1, 2025. CMS will ensure all evidence received will be sent to the MACs [Medicare Administrative Contractors] to review to determine if revisions to the LCD are appropriate.”
The Alliance of Wound Care Stakeholders had said the new LCD contained “seismic changes to the number of covered products, allowable applications, and required documentation in the final LCDs published in November 2024.”
The American Professional Wound Care Association (APWCA) issued a call in April for stakeholders to oppose the LCD as it currently stands.
The APWCA referenced a manuscript — The hidden costs of limiting access: clinical and economic risks of Medicare’s future effective cellular, acellular and matrix-like products (CAMPS) Local Coverage Determination — that has been accepted for publication by the peer-reviewed Journal of Wound Care.
“The policy imposes a rigid cap of eight CAMP applications over a 16-week episode of care regardless of clinical response, the APWCA said in an April 7 statement. “As providers on the front lines of wound care, we know this will worsen outcomes by increasing amputations, hospitalizations, and ED [emergency department] visits; restrict access for the most vulnerable Medicare beneficiaries; prevent physicians from exercising clinical judgment and practicing according to training; [and] ignore critical real-world evidence that proves the value of these treatments.”
The association urged members to contact senators and members of Congress to “urge them to oppose this future effective LCD as written. Tell them it puts patients at risk, undermines medical practice, and widens disparities.”
Members were encouraged to share their own professional experiences in treating hard-to-heal wounds; the impact they have seen of CAMPS on patient outcomes; and concerns over a “one-size-fits-all reimbursement cap.”
