Press Releases

Bipartisan House Bill Promotes Faster Access to Breakthrough Devices

WASHINGTON – Today, AdvaMed, the medtech association, released the following statement from President and CEO Scott Whitaker on the introduction of the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act. The bill, introduced by Representatives Brad Wenstrup (OH-02), Suzan DelBene (WA-01), Gus Bilirakis (FL-12), Tony Cárdenas (CA-29), Blake Moore (UT-01), Terri Sewell (AL-07), Brett Guthrie (KY-02), and Anna Eshoo (CA-16), would streamline Medicare coverage and reimbursement processes for innovative medical technologies.

“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,” said Whitaker. “We are thankful for Reps. Wenstrup and DelBene, and all our champions in Congress, for their leadership and commitment to patients. We look forward to working with Congress, CMS, and other stakeholders to move these policies forward.”

The bipartisan legislation would ensure FDA-designated breakthrough technologies are covered for four years by Medicare, and during this period CMS would be required to make permanent coverage determinations for the devices. This ensures safe and effective care is made available to millions of patients. In addition, the bill addresses temporary coverage for breakthrough devices that did not exist when Medicare was created.

Last year, AdvaMed, the largest trade association representing medical technology companies, urged CMS to issue its proposed Transitional Coverage for Emerging Technologies (TCET) rule, easing the way forward in expanding access to breakthrough technologies and address health disparities by setting a predictable pathway to national Medicare coverage for new devices and diagnostic tools.

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit