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CMS pushes back new skin-substitute coverage rules to Jan 1, 2026

CMS pushes back new skin-substitute coverage rules to Jan 1, 2026

The Centers for Medicare & Medicaid Services (CMS) has delayed the effective date of its Local Coverage Determinations (LCDs) for skin substitute grafts—impacting placental allografts—until January 1, 2026, citing a broader review to maintain patient access

Policy & Reimbursement Jan 01, 2025
BioStem completes enrollment in DFU trial of amnion-chorion allograft (BioRETAIN)

BioStem completes enrollment in DFU trial of amnion-chorion allograft (BioRETAIN)

BioStem Technologies has finished enrolling 71 patients in a clinical trial evaluating its amnion-chorion placental allograft (BioRETAIN) for diabetic foot ulcers (DFUs); topline data are expected in Q4 2025.

Clinical Research Jan 10, 2025
2026 Physician Fee Schedule proposal would standardize payment for all “skin substitutes”

2026 Physician Fee Schedule proposal would standardize payment for all “skin substitutes”

In the CY 2026 Physician Fee Schedule Proposed Rule, CMS outlines a single national payment rate (~$125.38/cm²) and shifts certain skin-substitute payments to incident-to supplies, changes that could reshape pricing dynamics for placental allografts in physician offices.

Policy & Reimbursement Jan 08, 2025

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