“A bill to amend title XVIII of the Social Security Act to reform the payment rules regarding skin substitute products.”
No CRS summary available for this bill.
This section sets forth congressional findings regarding skin substitute products used to treat chronic, non-healing wounds (e.g., diabetic foot ulcers and venous leg ulcers) in Medicare beneficiaries, including that more than 10.5 million beneficiaries require wound treatment annually; that such products vary in makeup (e.g., human tissue-derived, animal-derived, or synthetic) but are similarly safe and effective; that Medicare payment systems incentivize more expensive products and price increases despite similar clinical effects; and that Medicare expenditures for these products rose significantly in 2024 and 2025, necessitating payment and coverage reforms to contain costs.
This section establishes a new Medicare Part B payment methodology for skin substitute products (i.e., cellular, biological, or synthetic wound coverings intended to remain in the wound bed, including those cleared or approved under specified FDA pathways but excluding temporary dressings, liquids/gels/powders, or products approved as new drugs or biologics) beginning January 1, 2026, by amending SSA 1847A(b)(1) and (c)(6). The payment amount is the volume-weighted average of published Q4 2023 ASP pricing file limits, weighted by Part B units billed October-December 2023, with annual updates by the CPI-U for all urban consumers beginning in 2027; requires a new consolidated billing code by January 1, 2026; deems all such products reasonable and necessary under SSA 1862(a)(1)(A) absent evidence of contamination, infection, or serious adverse events; prohibits coverage denials based solely on clinical evidence analyses; and exempts manufacturers from ASP reporting. (Thus, this replaces ASP-based payments with a fixed, utilization-weighted 2023 baseline adjusted only by inflation.)