Medicare’s Breakthrough Coverage Proposal: Innovation, Evidence, and the Valley of Death

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CMS’ proposal for setting out an automatic coverage pathway for FDA-designated Breakthrough Devices seeks to address the period when medtech firms say innovative new devices are most vulnerable to failure. It also raises questions about the best approach to ensuring robust, long-term evidence collection for these new products that still have something to prove.

CMS made big news in the device industry last month with the release of its long-awaited proposal to award automatic Medicare coverage to FDA-approved Breakthrough Devices. Now industry and other stakeholders are pouring over the 45-page plan —which also for the first time codifies a definition for the “reasonable and necessary” coverage standard—to understand its impact and identify gaps that should be addressed in a final rule. Some observers suggest the year-to-year tangible effects of the plan might actually be quite small, but industry advocates, who have been pressing versions of the policy on CMS for years, argue it could significantly stimulate new medtech innovation efforts.

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