CMS Proposes Sweeping Changes to Skin Substitute Medicare Payment Policies for 2026: Uniform Rates, FDA Grouping, and Unpackaging in the HOPD/ASC
Skin Substitutes
The Centers for Medicare & Medicaid Services (CMS) has proposed significant changes to the payment methodology for skin substitute products under Medicare Part B.
In short:
CMS aims to create uniformity across physician offices, ambulatory surgical centers (ASCs), and hospital outpatient departments by treating these products as incident-to supplies and grouping them into three payment categories based on FDA regulatory pathways (PMA approvals, 510(k) clearances/De Novo authorizations, and 361 HCT/Ps).
Additional proposals include:
Unpackaging payments in hospital outpatient/ASC facility settings
Establishing an initial uniform rate of $125.38 per square centimeter across the physician office, ASC, and hospital outpatient sites of care
Introducing new unlisted codes to facilitate timely payments for emerging products
Proposed effective date: January 1, 2026
Comment deadlines: CMS encourages stakeholders to submit comments by September 12, 2025 when commenting regarding proposals related to the Medicare Physician Fee Schedule and by September 15, 2025 when commenting regarding proposals related to the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems.
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