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.
Event / Regulatory Affairs
January 26, 2023
12:00 PM – 1:00 PM
Blog / Coverage & Payment / Global & Trade / Government & Legislative Affairs / Health Equity / Investor Relations / Regulatory Affairs / Small Business
December 22, 2022
From MDUFA V and the major investments in semiconductor chip manufacturing in the CHIPS Act, to addressing global supply chain issues and supporting our AdvaMed Accel companies, 2022 was a year like no other.
News / Government & Legislative Affairs
December 21, 2022
The year-end spending package making its way through Congress includes key provisions championed by the Advanced Medical Technology Association (AdvaMed) that will benefit the patients served by the medical technology companies AdvaMed represents.
News / Government & Legislative Affairs / VALID Act
December 13, 2022
AdvaMed, joined by American Cancer Society Cancer Action Network, The Pew Charitable Trust, Friends of Cancer Research, and other, sent a letter urging the leaders of the Senate Committee on Health, Education, Labor and Pensions (HELP) and the House Committee on Energy and Commerce to support the bipartisan Verifying Accurate, Leading-edge IVCT Development (VALID) Act.
News / Government & Legislative Affairs
December 12, 2022
Today, the Advanced Medical Technology Association (AdvaMed) announced that Susan Askew has joined the association as PAC Director.
News / Government & Legislative Affairs
December 12, 2022
Today, the Advanced Medical Technology Association (AdvaMed) announced that Darbi Gottlieb has joined the Association’s state affairs team as director of state government and regional affairs.
News / Coverage & Payment / COVID-19 / Regulatory Affairs
December 6, 2022
Cary Vance, President and CEO of Titan Medical, joined AdvaMed’s Scott Whitaker on the MedTech POV podcast to share his experience leading a small medical device company through the regulatory process as they transition from design to manufacturing.
Resource / Ethylene Oxide / Government & Legislative Affairs / Regulatory Affairs
November 1, 2022
A false emerging narrative suggests ethylene oxide (EtO) sterilization is cheaper, easier, and faster than alternatives and thus preferred. Get the facts on the cost of EtO.

Copyright 2023 AdvaMed

source

Leave a Comment