The Coalition submitted comments to CMS' CY 2022 Hospital Outpatient Prospective Payment System (HOPPS), flagging issues with the synthetic skin substitute section of the proposed rule. Comments focused on:
• the definition and coding of synthetic resorbable skin substitutes.
• payment inequities in provider based departments impacting Medicare beneficiary access to skin substitutes (also known as CTPs).
• the requirement to consult with the FDA Tissue Reference Group (TRG) or obtain a Request for Designation (RFD) regarding being appropriately regulated solely under section 361 of the PHS Act and the regulation in 21 CFR part 1271.
See Coalition Comments
September 17, 2021