CMS Confirms 2026 Medicare Coverage for MTF Biologics’ AmnioBand and AlloPatch
MTF Biologics has secured a critical market-access win as the Centers for Medicare & Medicaid Services (CMS) finalized updated Local Coverage Determinations (LCDs) confirming that AmnioBand® Membrane and AlloPatch® Pliable will remain covered for the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). The coverage becomes effective January 1, 2026, positioning both products firmly within Medicare’s reimbursable wound-care toolkit.
Under the updated LCDs, CMS evaluated skin substitute grafts and cellular and tissue-based products (CTPs) against newly defined evidence thresholds. Of the products reviewed, only 18 tissues were designated as fully “covered,” reflecting a tighter evidentiary bar aimed at curbing utilization of lower-value wound products. AmnioBand Membrane and AlloPatch Pliable were among those meeting CMS’s clinical and economic criteria.
What You Need To Know
- AmnioBand and AlloPatch were among just 18 tissues granted full LCD coverage
- Coverage applies to both DFUs and VLUs, effective January 1, 2026
- CMS tightened evidence thresholds for skin substitute reimbursement
- Alignment with commercial payer policies supports broader adoption
The decision follows CMS’s December 15 announcement outlining a new three-tier framework classifying products as covered, non-covered, or subject to a 12-month status quo period. Products granted full coverage were determined to meet the LCDs’ requirements for published clinical evidence and therapeutic value, criteria that have become increasingly consequential for manufacturers operating in the crowded wound-care market.
The outcome reinforces the durability of its evidence-backed portfolio. Both AmnioBand Membrane, an allograft placental matrix, and AlloPatch Pliable, an allograft dermal matrix, are aseptically processed without terminal irradiation and supported by peer-reviewed randomized controlled trials. According to published data, the products demonstrate significantly higher wound-closure rates compared with standard of care, often achieving closure with fewer applications.
Notably, AmnioBand Membrane stands out as one of only five tissues covered for both DFUs and VLUs, expanding its clinical utility across two of the most prevalent and costly chronic wound indications in Medicare populations. That distinction is likely to resonate with providers seeking flexibility amid tightening coverage rules.
The updated LCDs also align closely with coverage policies adopted by many commercial health plans. This harmonization reduces payer friction for providers and distributors while supporting broader national uptake across both public and private markets.
MTF Biologics’ nonprofit status further differentiates the organization in a segment increasingly scrutinized for pricing and utilization practices. Company leadership emphasized its ongoing investment in clinical evidence generation, patient safety, and health-economic validation, factors that are becoming decisive as CMS sharpens its oversight of tissue-based wound therapies.