Last fall, CMS proposed a special coverage rule that would provide automatic, four-year coverage for Breakthrough Devices after FDA approval or clearance. On January 12, 2021, after market close, CMS released a fact sheet and the final rule, largely as proposed. It's called Medicare Coverage for Innovative Technologies - MCIT. The rule also includes a section where they codify in regulation some generic, longstanding Medicare policies about defining "reasonable and necessary," e.g. "meets the patient's need" and "provided by appropriate personnel."
- See CMS Fact Sheet here.
- See CMS final rule press release, here.
- See the final rule text here. (76pp)
- The full Federal Register typeset publication appeared on January 14, 2021 (86FR2987, 24pp).
- Coverage at MedCity News here. At MedTech Dive here.
- Within a week, January 18, a company with a breakthrough device review underway raised $100M (Paige.AI), here. Coverage of MCIT at Forbes, here.
MCIT & Opposition