The Alliance submitted comments to the director and deputy director of CMS' Hospital and Ambulatory Policy Group to augment oral comments shared at the Agency's January 2023 Skin Substitute Town Hall. "Any efforts by the Agency that will curtail access to CTPs will have a direct impact on infection and amputation rates," wrote the Alliance, noting that CMS "has failed to provide any assessment of this impact or details about its rationale for the change such as: an impact analysis, details on how CMS will implement bundling in the physician office setting, the criteria used for setting the rates, or the reasons for making this seismic change. Moreover, the Agency has not demonstrated that the bundling of these products will not impact access to these products, especially to our greatly underserved Medicare patient populations who suffer disproportionately." The Alliance included a list of detailed questions for the Agency to address and suggested that CMS develop a framework document where such questions could be answered - and vetted with stakeholders -  prior to any new rulemaking taking place.

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