Press Releases

AdvaMed Commends CMS Breakthrough Device Proposal


Mark Brager
[email protected]

WASHINGTON, D.C. – Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on the Trump Administration’s budget proposal to improve Medicare beneficiary access to breakthrough devices: 

“Currently, the latest innovations that FDA designates as ‘breakthrough’ devices – those that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions – have an expedited path to market. But there is no equivalent path at CMS so these important technologies can efficiently obtain coverage and get to the patients who need them.  

“The Administration’s FY 2020 budget plan to provide Medicare coverage for up to four years to beneficiaries participating in clinical trials of FDA-designated breakthrough devices is an important step toward providing patients expedited access to these life-saving devices. In addition, the plan will incentivize companies to continue to develop these breakthrough devices. 

“HHS Secretary Azar and CMS Administrator Verma are strong proponents of medical innovation and the solutions it can provide for our most pressing health care challenges. We thank the Secretary and Administrator for their leadership on this issue. We look forward to learning more details of the Administration’s proposal and working with them to explore additional ways to improve patient access to medical technologies.   

“We are also encouraged by the Administration’s proposal to strengthen and increase transparency of the current FDA-CMS parallel review program and to encourage adoption of innovative technologies through bundled payment demonstrations.”