FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a final rule issued this week by the Centers for Medicare and Medicaid Services (CMS).
The Medicare Coverage of Innovative Technology (MCIT) rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices and certain diagnostic tests. The coverage would last for four years, during which CMS would specify what additional data, if any, would be needed to maintain coverage after the four-year coverage period expires.
Breakthrough devices authorized within two years before the date the final MCIT rule became effective will also be eligible for coverage, but only for four years from FDA authorization. CMS will not pay claims will not be retroactively before the Jan. 12, 2021, effective date of the rule.
An October 2019 executive order by President Trump also focused in part on streamlining coverage, coding and payment for innovative technology, including breakthrough medical devices. The final rule codifies a definition of “reasonable and necessary” for items and services that may be covered under Medicare Part A and Part B and will apply to all Medicare items and services, not just those covered through the MCIT pathway.
CMS officials said in a news release that they believe four years of Medicare coverage will encourage manufacturers to voluntarily develop evidence to show these treatments improve the health of Medicare patients. When MCIT coverage sunsets, manufacturers will have all current coverage options available such as a national coverage determination (NCD), one or more local coverage determinations (LCD), and claim-by-claim decisions.
“We listened to stakeholders who commented on the proposed rule, so in the final rule CMS will gather more information about utilizing commercial insurer coverage policies and then utilize them under specific circumstances,” the CMS news release said. “Under the definition, generally, items and services will have to be safe and effective, not experimental or investigational, and appropriate for Medicare beneficiaries, but if there is insufficient evidence regarding appropriateness for national or local coverage determinations (NCDs or LCDs), we can look to commercial insurer policies to see how they have addressed coverage.”
Medtech trade group AdvaMed praised CMS for extending Medicare coverage for breakthrough devices.
“Too many of our seniors are afflicted by conditions for which no treatment options exist. From heart failure to cancer, from Alzheimer’s to diabetes, too many are suffering with ailments that actually could be treated with next-generation care,” said AdvaMed president & CEO Scott Whitaker in a statement. “It’s good government, and it’s good common sense to recognize that if doctors and scientists at the FDA — the global gold standard for medical technology regulation — determine a device is safe and effective, another federal agency can then move quickly to ensure patients can access that lifechanging and often lifesaving technology. We urge the incoming administration to keep this important step forward for our seniors in place, and we look forward to working closely with them on its implementation.”
