AdvaMed Urges CMS to Issue Proposed TCET Rule This Year … – AdvaMed

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed), the world’s largest trade association representing medical device manufacturers, urged the U.S. Centers for Medicare & Medicaid Services (CMS) to issue its proposed Transitional Coverage for Emerging Technologies (TCET) rule. The proposal has enormous potential to ease health disparities by setting a predictable pathway to national Medicare coverage for new medical devices and diagnostic tools.
From the letter: “We believe that CMS, in order to advance its health equity and other goals, can and must play a critical role in advancing access to emerging innovations that would improve health outcomes for the array of Medicare beneficiaries it serves. We also believe that we share a common goal – the establishment of a clear and expeditious coverage process, based on scientifically sound clinical evidence with appropriate safeguards, for emerging technologies that will benefit Medicare-eligible patients.”
AdvaMed’s letter outlined practical considerations that CMS easily could incorporate into its proposed rule, reflecting feedback from the medical technology companies that are continuously developing products and methods to diagnose illness, treat disease, and ease discomfort to save lives and improve quality of life.
Issuing the proposed rule quickly is important to ensure the proposal receives efficient yet thorough consideration in a typically long rulemaking process. Medicare beneficiaries deserve timely rulemaking on coverage policies affecting their well-being.
In late 2021, CMS announced it would propose a new rule called TCET after repealing the Medicare Coverage of Innovative Technology (MCIT) rule. The MCIT rule would have provided four years of automatic coverage for FDA-approved breakthrough-designated products. In addition to urging the release of a proposed TCET rule, AdvaMed supports related legislation pending in Congress.
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