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Crossing The 'Valley Of Death': Breakthrough Devices Rule Could Lead To Slew Of New Products

A new proposed rule would give automatic new technology add-on payments to breakthrough devices. While it may affect only a very small sector of the industry, the lobby group AdvaMed says it is a good first step to getting broader coverage for all devices and will incentivize companies to invest in breakthrough device research.

CMS
Sree Chaguturu (left), chief population health officer at Partners HealthCare System, talked to CMS Administrator Seema Verma (right) at the 2019 World Medical Innovation Forum in Boston about government's role in health care. • Source: Ferdous Al-Faruque

Breakthrough medical devices could temporarily be covered by Medicare under a new proposed rule from the Centers for Medicare and Medicaid Services that would allow data to be collected so the agency can figure out how much it should reimburse for the products. If finalized, the move could be a game-changer for industry, which has long complained of a so-called “valley of death” between the time their product is approved and when it finally qualifies for reimbursement.

CMS proposed a long-awaited rule on April 23 that would allow products deemed Breakthrough Medical Devices by the US FDA to be reimbursed for two years while the agency collects additional data to show they have substantial clinical improvement that qualifies the products for its new technology add-on payment policy

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