AdvaMed Commends Positive Step Toward Greater Medicare Coverage of Breakthrough Medtech

AdvaMed, the Medtech Association, the largest trade association representing medtech innovators, has long pressed for faster Medicare consideration of covering treatments using FDA-authorized breakthrough medtech. President and CEO Scott Whitaker made the following comment on a new initiative from FDA Commissioner Makary and CMS Administrator Oz on greater collaboration between the agencies to close the long gap - a median of nearly six years - between FDA authorization of breakthrough medtech and Medicare coverage. The new Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway would "expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare," according to FDA.

"Today's announcement is a positive step toward expanding Medicare beneficiaries' access to the FDA-authorized, safe, and effective breakthrough medtech they desperately need. As Dr. Oz and Dr. Makary have said publicly, more can and must be done for these patients who lack options and are suffering.

"While we appreciate this first step toward improving coverage, it is critical that the implementation of such a proposal is effective. Without meaningful timelines, accountability, and effective management of this program, patients are unlikely to see the full benefits of new technologies. We look forward to continuing our work with CMS to ensure Medicare beneficiaries have full, timely access to all the lifesaving, life-changing benefits breakthrough medtech offers-as soon as possible after FDA clearance.

"We also remain concerned about CMS's recent proposal to repeal the New Technology Add-on Payments (NTAP) to hospitals that cannot afford to offer patients procedures involving FDA-authorized breakthrough medtech without these already-modest, temporary payments. We will continue to work closely with CMS to shore up the NTAP program and its critical role in serving Medicare beneficiaries.

"It is important to remember who is on the receiving end of these statutorily defined 'breakthrough' medical technologies that have gone through the rigorous FDA review process: patients in need who currently lack medical options for the conditions from which they are suffering-and their expert doctors and care teams seeking the best medicine has to offer in order to alleviate that suffering