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.
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A CMS official announced that the agency is working on a proposal to replace breakthrough device coverage scheme MCIT that will balance ensuring product safety with narrowing the “valley of death.”
The rule was set to go into effect 15 March, but the government is delaying it for at least two months to discuss the resources needed for the payments – and whether they’re the right policy to start with.
The long-awaited proposed rule from the US Medicare agency would allow breakthrough products approved by the FDA to get reimbursed, while manufacturers continue to collect clinical and real-world data.