Dive Brief:
- AdvaMed and 66 other groups have asked the Centers for Medicare and Medicaid Services to create a streamlined pathway for covering breakthrough medical devices.
- A letter to CMS Administrator Dr. Mehmet Oz, which AdvaMed shared Wednesday, quotes a study that found nearly six years passed between Food and Drug Administration authorization and Medicare coverage of technologies that required new reimbursement pathways.
- AdvaMed wants Oz to accelerate access by adopting a program that mirrors parts of the withdrawn Medicare Coverage of Innovative Technology framework, known as MCIT.
Dive Insight:
AdvaMed joined with patient advocacy groups and state medtech and life sciences associations to write the letter. The groups said they are encouraged by Oz’s “early focus on exploring options for a better pathway for recently approved medical devices.” Oz said at his confirmation hearing in March that Medicare should cover newly approved medical devices more quickly.
Now, AdvaMed and the other groups want the CMS to take “bold action.” The groups named the MCIT as an inspiration for their proposals, arguing that a program that mirrors core aspects of the framework would be better than existing pathways. The MCIT would have provided immediate national coverage for four years for any new breakthrough medical device or diagnostic approved by the FDA.
AdvaMed pitched its preferred approach as a way to ensure Medicare patients get more timely access to devices authorized by the FDA and to provide “a clear, predictable roadmap for CMS to collect additional necessary evidence for making a permanent coverage decision.”
The MCIT was contentious, though, leading the CMS to rescind the program in 2021. While the medtech industry opposed the withdrawal of the MCIT, groups including the Association of American Medical Colleges pushed for the program to be rescinded. AAMC warned that the safety and effectiveness of breakthrough devices in the MCIT population may be unknown.
Legislators have sought to enshrine aspects of the framework in U.S. law, starting with a draft version of the 21st Century Cures Act in 2021 and continuing to a bill that a senator introduced in May. However, the lack of legislative progress has left companies reliant on existing initiatives that AdvaMed and the other groups argue are inadequate.
“Existing programs, including the Transitional Coverage of Emerging Technologies program, fall short of providing the consistent, timely and predictable access that breakthrough technologies demand,” the groups wrote. “Its voluntary nature and limited scope – among other issues – fall short of delivering the life-changing innovations to patients who need them most.”
