iBIO has joined AdvaMed and 65 other organizations in urging the Centers for Medicare and Medicaid Services (CMS) to create a streamlined pathway for Medicare patients to access FDA-authorized breakthrough medical technology. The coalition’s letter to CMS Administrator Dr. Mehmet Oz addresses a critical problem: nearly six years pass between FDA authorization and Medicare coverage for technologies requiring new reimbursement pathways.
“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 states. The coalition includes patient advocacy groups and state medtech and life sciences associations.
“FDA is the global gold standard with its rigorous medtech safety and efficacy standards,” said Scott Whitaker, AdvaMed president and CEO. “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.”
The coalition’s proposal draws from the withdrawn Medicare Coverage of Innovative Technology (MCIT) framework, which would have provided immediate national coverage for four years for breakthrough medical devices. The effort is gaining momentum as FDA Commissioner Marty Makary said he and Dr. Oz are working on automatic coverage of FDA-authorized breakthrough medtech to avoid a “repeat, duplicative approval process.”
U.S. senators have also introduced the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act to accelerate Medicare coverage. The groups argue that existing programs “fall short of providing the consistent, timely and predictable access that breakthrough technologies demand.”
iBIO’s participation reflects the company’s commitment to advancing biotechnology innovation and patient access, recognizing that reimbursement challenges can significantly impact breakthrough technology adoption.
Read the letter. Read AdvaMed’s press release.