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December 6, 2019

House Bill Would Improve Medicare Patient Access to Breakthrough Technologies

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker on the introduction of legislation in the U.S. House by Reps. Suzan DelBene (D-Wash.), Jackie Walorski (R-Ind.), Tony Cardenas (D-Calif.), Gus Bilirakis (R-Fla.), Roger Marshall (R-Kan.), and Terri Sewell (D-Ala.) to streamline Medicare coverage and reimbursement processes for innovative medical technologies:  

“CMS has made great strides in recent months to ensure Medicare beneficiaries have access to the most innovative medical care, and this important legislation would build on these critical reforms,” said AdvaMed president and CEO Scott Whitaker. “We thank Reps. DelBene, Walorski, Cardenas, Bilirakis, Marshall, and Sewell for their leadership and their commitment to ensuring patients and physicians benefit from breakthrough medical technologies in a timely manner. We look forward to working with Congress, CMS, and other key stakeholders to move the bill forward.” 

While FDA has an established process to identify and give priority review to new breakthrough technologies for serious illnesses, there is no equivalent process at CMS to facilitate coding, coverage and payment. This means Medicare patients must often wait years to benefit from these innovations due to frequent coverage and reimbursement delays. The legislation introduced today by will help bridge this gap and ensure American patients the access to new treatments and therapies they deserve. 

Under the legislation, for any new device or diagnostic designated as a breakthrough technology and deemed safe and effective by FDA, CMS would provide immediate transitional coverage for three years and ensure payment and coding are available. During the three-year coverage period, CMS would specify what additional data, if any, would be needed to continue coverage after the transition.  

This legislation also recognizes that many FDA-approved or cleared breakthrough devices are not covered by Medicare because they do not fit within a benefit category. It also ensures that these innovative technologies are covered by Medicare and accessible to its beneficiaries.