Proposed Rule Aims to Hasten Access to Breakthrough Medical Devices

Carrying out another directive from President Trump’s Medicare-focused executive order issued last fall, CMS on Aug. 31 released a proposed rule that aims to fast-track Medicare coverage of certain innovative FDA therapies once they are approved. Although the rule applies to Medicare fee for service, it has implications for Medicare Advantage organizations that are required to cover Medicare Parts A and B approved services.

According to a CMS fact sheet on the rule, CMS is proposing a new Medicare coverage pathway, Medicare Coverage of Innovative Technology (MCIT), for medical devices that are granted breakthrough designation by the FDA. The MCIT proposal would allow for national Medicare coverage on the same day as a breakthrough device receives FDA approval. CMS proposes a coverage duration of four years, which it suggests will “encourage manufacturers to voluntarily develop evidence to show these treatments improve the health of Medicare patients.”

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