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CMS proposes new rule for faster Medicare coverage of FDA-approved breakthrough devices

John R. Fischer, Senior Reporter | September 04, 2020
Emergency Medicine Insurance

“For new technologies, CMS coverage approval has been a chicken and egg issue,” said CMS Administrator Seema Verma in a statement. “Innovators had to prove their technologies were appropriate for seniors, but that was almost impossible since the technology was not yet covered by Medicare and thus, not widely used enough to demonstrate their suitability for Medicare beneficiaries. These efforts will ensure seniors get access to the latest technologies while lowering costs for innovators.

While ECRI acknowledges that the new pathway will enable quicker access to certain medical devices, it is concerned about the pathway's affect on safety. "This new approach offers no advantage for patient safety because it enables public access earlier to medical devices that have will likely have fewer safety data than one would expect from a full PMA pathway," said its director of health technology services, Diane Robertson.

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Devices participating in the FDA’s Breakthrough Device Program would also be eligible for MCIT. Any MCIT-participating device would need to fit within a statutory Medicare benefit category. Following notification, CMS would coordinate with the FDA and manufacturer to work out details prior to the start of coverage.

In providing national Medicare coverage for four years, the MCIT rule is expected to streamline LCDs and promote equal access for seniors, while helping manufacturers focus on delivering their devices to patients and clinicians, according to Policy and Medicine.

CMS will post a list of breakthrough devices covered through MCIT and the duration of coverage on its website.

It is specifically asking for comments on whether MCIT should be extended to other categories, such as diagnostics, drugs, and biologics reviewed under expedited approaches, including Breakthrough Therapy or Priority Review. It also is seeking comments as to whether all diagnostics, drugs, and biologics should be MCIT-eligible. The proposed rule, however, addresses only devices, due to CMS believing there to be more uncertainty for devices than other items and services.

All comments must be submitted by November 2, 2020.

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