Regulatory Update: Calendar Year 2026 Medicare Physician Fee Schedule Final Rule (CMS-1832-F)
Summary: The Centers for Medicare and Medicaid Services (CMS) finalized the 2026 Physician Fee Schedule (PFS) rule, introducing a standardized payment model for skin substitute products under Medicare Part B. Published on October 31, 2025, the rule sets a flat rate of $127.28 per square centimeter for these products applied in private offices and the professional component in hospital-based outpatient departments (HOPD). This replaces previous unique payment limits, addressing a cited 40-fold payment increase over five years. Separate reimbursement continues for application services. Exceptions apply to products classified as biologicals under section 351 of the Public Health Service Act. The rule takes effect January 1, 2026, and does not affect the WISeR model or upcoming local coverage determinations (LCDs) for skin substitutes in diabetic foot ulcers and venous leg ulcers.
Key Highlights:
- Standardizes skin substitute payment at $127.28 per square centimeter for Medicare Part B.
- Applies to private offices and HOPD professional components, effective January 1, 2026.
- Addresses prior 40-fold payment increase over five years with a flat rate.
- Maintains separate reimbursement for product application services.
- Exceptions for biologicals under Public Health Service Act section 351; no impact on WISeR or LCDs for diabetic/venous ulcers.
Keywords: Medicare PFS, skin substitutes, wound care reimbursement, DFUs, VLUs