AdvaMed Voices Support for Timely, Streamlined Breakthrough Tech Pathway

AdvaMed, the Medtech Association, is among 67 stakeholder groups urging the Centers for Medicare and Medicaid Services (CMS) to establish a timely and efficient process for Medicare beneficiaries to access U.S. Food and Drug Administration (FDA)-authorized breakthrough medical technologies.”

In a letter to CMS Administrator Dr. Mehmet Oz, the 67 organizations noted that medical technology enables remarkable patient outcomes, yet FDA-designated, authorized breakthrough solutions face years of delays in Medicare coverage. 

“Despite this remarkable impact and the continuous pace of innovation, Medicare patients face a significant and unacceptable barrier to accessing innovative medical technology,” the letter states. “A recent study alarmingly revealed that for technologies requiring a new reimbursement pathway, nearly six years passed between FDA market authorization and Medicare coverage. Patients should not be forced to wait the better part of a decade for access to safe and effective medical technology that holds the potential to meaningfully improve their health and life.”  

A streamlined, predictable Medicare coverage pathway for medtech the FDA has deemed useful, safe, and effective would “demonstrate CMS’ commitment to patient-centered care and ensure that Medicare beneficiaries can benefit from the rapid advancements in medtech without unnecessary delays, helping make for a stronger, healthier country,” the letter continued. 

“FDA is the global gold standard with its rigorous medtech safety and efficacy standards,” AdvaMed President/CEO Scott Whitaker said. “When FDA has identified a medtech solution as a ‘breakthrough’ and cleared it as safe and effective for patients, we believe Medicare should cover it. As this Administration and AdvaMed work toward our mutual goal of making Americans healthy again, I want to thank Dr. Oz and Commissioner Makary for their commitment to improving Medicare beneficiaries’ access to the breakthrough medtech that could improve their health and even save their lives.” 

AdvaMand and other organizations that signed the letter criticized the long waiting period between a product’s breakthrough designation and its authorized Medicare coverage. “Patients should not be forced to wait the better part of a decade for access to safe and effective medical technology that holds the potential to meaningfully improve their health and life,” the letter noted.

The effort to achieve breakthrough coverage is gaining momentum. In a recent interview, FDA Commissioner Marty Makary said he and CMS Administrator Dr. Oz were working on automatic coverage of FDA-authorized breakthrough medtech to avoid a “repeat, duplicative approval process.” 

U.S. senators also have introduced the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act to accelerate Medicare coverage.