CMS proposes new TCET pathway for Medicare coverage of breakthrough devices

The Centers for Medicare & Medicaid Services (CMS) is proposing the new Transitional Coverage for Emerging Technologies (TCET) pathway for breakthrough devices to secure Medicare coverage.

The voluntary program would expedite Medicare coverage for new medtech innovations, offering an estimated three to five years of transitional coverage. CMS repealed a similar program, Medicare Coverage of Innovative Technology (MCIT), in 2021, citing concerns that it may have covered devices without adequate evidence.

The new TCET proposal “supports both improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population,” CMS said in a statement.

CMS will be taking public comment on the notice for 60 days after publication. The notice is scheduled for publication on June 27, 2023.

CMS is currently seeking public comment on new guidance on evidence…

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AdvaMed pushes CMS for proposed TCET pathway rule this year

The Advanced Medical Technology Association (AdvaMed) is asking the Centers for Medicare & Medicaid Services (CMS) to move fast on a new way to guarantee reimbursement for new medtech innovations.

CMS repealed the Medicare Coverage of Innovative Technology (MCIT) program last year but promised to explore other options to improve the coverage process for access to innovative and beneficial medical devices.

Now, a pathway called the Transitional Coverage for Emerging Technologies (TCET) program could take its place. CMS and medtech industry representatives have discussed the need for Medicare coverage reforms in two listening sessions (transcripts with webinar replay information are here and here).

In an Aug. 1 letter to CMS Administrator Chiquita Brooks-LaSure and Principal Deputy Administrator and COO Jon Blum, AdvaMed called on them to issue a proposed rule this year.

“We believe that CMS, in order to advance its health equity and other…

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