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AdvaMed Statement on CMS’s Proposed Rule for Breakthrough Technology Coverage


 AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker on the recently issued proposed Transitional Coverage for Emerging Technologies (TCET) rule:

“We’re pleased that CMS has finally issued the TCET notice.  While the draft rule requires further review, we are pleased that CMS recognizes the need to improve the coverage process for seniors. We continue to believe that immediate coverage of FDA approved technologies represents the best path forward to ensure seniors receive the benefits they need and America’s Medtech companies continue to lead the world in medical innovation.  We look forward to reviewing draft rule and working work with CMS and Congress to bring the certainty and transparency to medical innovation that American seniors deserve.”

During the rulemaking process, AdvaMed wrote to CMS, outlining practical considerations the agency could easily incorporate into its proposed rule, reflecting feedback from the medical technology companies that are developing products and methods to diagnose and treat diseases, improve patient quality of life, and save lives.

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.”

In March, the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act was introduced in the House of Representatives by Reps. Brad Wenstrup (OH-02) and Suzan DelBene (WA-01). In response to the introduction of the bill, Whitaker said, “Access to innovative, FDA-approved breakthrough technologies is vital for Medicare beneficiaries who are working with their doctors to treat illnesses and live healthy lives. This legislation is an important part of the ongoing reforms that are taking place within CMS to make this a reality for patients.” 

Improving patient access to breakthrough medical technologies is a top priority this year for AdvaMed, highlighted in the organization’s Medical Innovation Agenda for the 118th Congress earlier this year. 

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