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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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.
After an eleventh-hour win last year that saw Congress repeal the medical device excise tax, AdvaMed is going more global. CEO Scott Whitaker sat down with Medtech Insight for a lengthy chat about what the lobby group will focus on in 2020, including reimbursement challenges, the upcoming medical device user-fee negotiations, and negotiations with governments that are key to the industry ecosystem.