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

Executive Summary

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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News We’re Watching: TCET Pathway Announced, QSMR Final Rule Date Announced, Vitang Dental Aligner Post-Approval Changes

CMS publishes a long-awaited proposal for coverage of breakthrough devices, the Office of Information and Regulatory Affairs confirmed a December 2023 release date for the final QMSR rule, and dental technology company Vitang Technology LLC is accused of violating QSR standards.

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.

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

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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