BioStem Secures Patient Access After CMS Reverses Ulcer Treatment Restrictions

BioStem Technologies has welcomed a key decision by the Centers for Medicare & Medicaid Services (CMS). The agency withdrew seven Local Coverage Determinations (LCDs) for skin substitute grafts and cellular products used in treating diabetic foot ulcers (DFU) and venous leg ulcers (VLU). These changes were originally set to take effect in January 2026 but will no longer proceed as planned.

The withdrawal ensures that patients can continue accessing BioStem's VENDAJE and VENDAJE AC products without interruption.

CMS had proposed new LCDs that would have affected coverage for advanced wound care treatments. The now-withdrawn policies targeted skin substitutes and tissue-based products, including those used for DFU and VLU. BioStem, a leader in perinatal tissue-based regenerative therapies, had raised concerns about potential restrictions on patient access.

The company's portfolio includes AmnioWrap2, VENDAJE, VENDAJE AC, VENDAJE OPTIC, American Amnion, and American Amnion AC. All products are processed at BioStem's FDA-registered and AATB-accredited facility in Pompano Beach, Florida. The withdrawal of the LCDs does not alter the company's ability to serve patients or clinicians.

BioStem's CEO, Jason Matuszewski, acknowledged the role of clinical partners, policymakers, and advocacy groups in shaping the reimbursement landscape. He emphasised the importance of collaboration in ensuring fair access to innovative treatments. The company remains focused on an evidence-based approach to drive long-term adoption and value for its products.

With the LCDs no longer moving forward, BioStem's wound care solutions remain available to those in need. The decision removes a potential barrier for patients relying on advanced therapies for chronic ulcers. The company continues to prioritise research and partnerships to support broader acceptance of its regenerative treatments.