Biocom MCIT Pathway Comment Letter Final – April 16, 2021

The 21st Century Cures Act of 2016 led to the creation of the Breakthrough Devices Program to expedite the review and approval process for innovative devices and diagnostics. [...] Biocom California notes that commentors previously raised this issue during the draft period of the document, and CMS addressed it in the final rule, noting “a detailed description of coding and payment is beyond the scope of the MCIT rule and resides in other payment rules.” (86 FR 3002). [...] New Information: Breakthrough Device Volume CMS notes the regulatory impact analysis (RIA) published as part of the MCIT final rule was based on the expectation that the Food and Drug Administration (FDA) breakthrough device program would initially apply to a relatively small number of devices based on the low number of breakthrough devices that had become market authorized. [...] Regardless, it is also important for CMS to recognize the significant benefits to both patients and long-term savings to the health care system if the number of devices eligible for the program increases in the future. [...] Further, contrary to the article CMS cites in the IFR by Neumann and Chambers, many products have long lifespans and even if the next generation of products are available, manufacturers have significant incentives to continue to assess products and provide strong clinical evidence for long-term CMS coverage after the MCIT period, as well as to obtain commercial insurer coverage.