February 10, 2023
Following oral remarks made at CMS' January 2023 Skin Substitutes Town Hall meeting, the Coalition submitted written comments to expand upon its remarks and reiterate to the Agency that the proposed seismic changes to the payment methodology for CTPs ("skin substitutes") will lead to significant limitations on the access to care for numerous patient populations including but not limited to: minorities, patients in rural areas and patients with diabetes. "The bundling of skin substitutes is not in the best interest of Medicare beneficiaries who are likely going to be subjected to unnecessary anesthesia and longer waits to get their wounds treated as operating room time is difficult to come by. Most importantly, as a result of the potential to limit access to care, there could be increases in infections, amputations, and sadly, loss of life," wrote the Coalition. The Coalition urged CMS to NOT move forward with any proposed rulemaking for CY 2024, but instead to issue a "framework document" – as it did for 505 (2)(b) drugs – to allow for substantive information to be provided by the Agency for stakeholders to react to in a more informed fashion.  
Read Coalition comments
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