USA – MCIT: Not a better way to pay for breakthrough devices

The Medicare Coverage of Innovative Technology (MCIT) pathway should be rescinded because it does not require thorough evidence of the safety and efficacy of the medical device for which it aims to provide coverage, Vinay K. Rathi, MD, of Harvard Medical School and colleagues wrote in a perspective published in the New England Journal of Medicine.

MCIT would provide up to four years of Medicare coverage for medical devices authorized under the US Food and Drug Administration (FDA) Breakthrough Devices Program. The rule authorizing MCIT was finalized in the last fortnight of the Trump administration. The pathway was set to become effective on 15 March but has been held up by the regulatory freeze instituted at the start of the Biden administration. 
While most Medicare coverage decisions are made at the local level by Medicare administrative contractors, MCIT would create National Coverage Decisions (NCD) for qualifying devices authorized under the Breakthrough Devices Program…