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Breakthrough Devices To Get Special US Medicare Reimbursement Under CMS Proposal

 
• By Sue Darcey

The US Centers for Medicare and Medicaid Services plans to automatically allow reimbursement and up to 65% new technology add-on payments for US FDA-approved, -cleared or de novo devices in the agency's Breakthrough Devices Program. Industry groups, including the Medical Device Manufacturers Association and AdvaMed, have been pushing CMS for such coverage for several years.

CMS is proposing to provide coverage of FDA breakthrough devices

For the first time, US FDA breakthrough devices would be granted Medicare reimbursement by the Centers for Medicare and Medicaid Services without first meeting CMS' “substantial clinical improvement” requirements when compared to existing devices it already reimburses.

Industry groups have long called for CMS to permit such reimbursements. (Also see "CMS Actively Looking For New Reimbursement Pathway For Innovative Devices" - Medtech Insight, 28 September, 2018.)

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