Game-Changer? CMS Proposes Rule To Cover Breakthrough Devices On Provisional Basis

In a hotly anticipated decision, the US Centers for Medicare and Medicaid Services has proposed a rule that would give four-year conditioned coverage for breakthrough medical devices and diagnostics. The rule could be a game-changer for an industry that has bemoaned the fact that after products are cleared for market, the CMS is unwilling to reimburse health care providers due to lack of supporting data.

Over the past few years the CMS has repeatedly promised it was on the verge of proposing a rule that would provide immediate coverage for products that are cleared by the Food and Drug Administration through its breakthrough devices program. The Medicare agency on 31 August finally published its Medicare Coverage of Innovative Technology (MCIT) proposed rule, which the CMS says will close the “valley of death” – a term coined by the medtech industry