Game-Changer? CMS Proposes Rule To Cover Breakthrough Devices On Provisional Basis
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.
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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.
Both insurance group AHIP and the MedPAC group of Medicare advisors are insisting on CMS reimbursement for medical devices only supported by clinical trials. Industry attorneys weigh in.
Podcast: Impulse Dynamics CEO Says CMS Breakthrough Rule Could Boost R&D (And Is Good Use Of Tax Dollars)
Following the US Medicare agency’s recent proposed rule to give immediate national coverage for breakthrough devices, Simos Kedikoglou spoke with Medtech Insight about what it could mean for companies like his.