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US Representatives Urge CMS To Insure Coverage Of Breakthrough Technology By Year’s End

Executive Summary

Four US representatives sent a letter to CMS urging them to pass a the TCET proposed rule by the end of 2022. 

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Industry Leaders Urge Congress, CMS To Expand Coverage Of Breakthrough Devices

Medtech leaders urged Congress to ensure coverage of breakthrough devices during a hearing by the House Ways and Means Subcommittee on Health.

News We’re Watching: Medicare Prepares To Release TCET, Regulatory Clearances For Medasense and Methinks AI

A new regulatory agenda from the US Department of Health and Human Services shows that a proposed rule coverage for breakthrough devices is expected in the near future. Additionally, new technology to monitor patent pain during surgery and triage stroke patients got regulatory approvals, and the US FDA added to its webpage on device misconnections. 

Industry Advocates Cautiously Optimistic About CMS Proposal For Coverage Of New Devices

Trade groups like Medical Device Manufacturers Association and AdvaMed are optimistic for a reimbursement pathway for new medical devices but are awaiting further details. 

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