Weekly Policy Update: CMS Issues Proposed Rule to Improve Coverage for Breakthrough Technologies

This week the Centers for Medicare & Medicaid Services (CMS) released the long-awaited proposed rule on “Medicare Coverage of Innovative Technologies.” The proposed rule would make significant changes to streamline Medicare coverage for FDA-designated breakthrough technologies that have market authorization.  

Automatic Coverage for Breakthrough Technologies: The proposed rule would create a new, voluntary Medicare Coverage of Innovative Technologies (MCIT) pathway that would provide immediate, national Medicare coverage of any FDA-market authorized breakthrough device if the device meets certain criteria. This automatic coverage would begin on the date of FDA-market authorization and would last for four years, after which time coverage would be determined through existing processes (national or local coverage determinations, or claim-by-claim adjudication).

Read a summary of the key provisions in the rule.

Earlier this year, CBSA met with members of our Congressional delegation in Washington, DC to discuss the hurdles medical technology companies face in navigating the coverage and reimbursement process. We asked for support in establishing a transitional coverage and payment pathway for breakthrough technologies, to incentive innovative medical breakthroughs. We are encouraged by the proposed rule, which aims to address many of the issues we discussed and represents an important step in ensuring patient access to innovative technologies.

CBSA will continue working with our members and industry partners to convey our support for the new pathway and advocate for policies that will improve the coverage of life-changing technologies.

More information about the proposed rule can be found in the CMS Factsheet.

Comments are due October 29th.

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