GRAFIX PRIME, GRAFIX PL PRIME and OASIS WOUND MATRIX are covered.
All Seven (7) Medicare Administrative Contractors (MACs) Release Final Local Coverage Determinations (LCDs) for Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
On November 14, 2024, these seven Medicare Administrative Contractors (MACs) -- CGS (Cigna Government Services), FCSO (First Coast Service Options), NGS (National Government Services), Noridian, Novitas, Palmetto, and WPS (Wisconsin Physicians Government Health Administrators) -- released their FINAL LCDs titled “Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers.”
The effective date of the final LCDs is February 12, 2025. All 50 states and the District of Columbia are impacted by the final LCDs.
The seven MAC’s final LCDs limit coverage to 8 applications of skin substitute graft/CTP product in a 12 to 16 week episode of treatment. For applications 5-8 of a skin substitute, the claim must be appended with a KX modifier. KX modifier serves as an attestation from the provider showing that the medical necessity requirements specified in the applicable LCD have been met. According to the LCDs, greater than 8 applications of a skin substitute graft/CTP within an episode of care (up to 16 weeks) is considered not reasonable and necessary.
Criteria cited by the MACs to determine skin substitute coverage includes:
The skin substitute must be “supported by high-certainty supporting evidence to demonstrate the product’s safety, effectiveness, and positive clinical outcomes in the function as a graft for DFU and/or VLU. Substantial equivalence to predicate products does not allow sufficient evidence to support similar cleared products.”
GRAFIX PRIME AND GRAFIXPL PRIME (Q4133), and OASIS WOUND MATRIX (Q4102) are included in the list of Covered Skin Substitutes (Groups 2 and 3 codes). The MACs list only eighteen (18) covered skin substitutes. For a full list of covered products please refer to the LCDS at the links provided below. 204 products are listed on the non-covered list (Group 4 Codes).
You may access the Final LCDs and Billing and Coding Articles at the following links: