Paving the Pathway

by James Cavuoto, editor

In the time that has transpired since the medical device industry mourned the loss of the Medicare Coverage of Innovative Technology program, more than a handful of neurotech companies, including many startup firms, have felt the pain. After being promised they would qualify for at least four years of CMS coverage once they got FDA approval, recipients of breakthrough device designation found out that was just a cruel ruse when CMS pulled the plug on the MCIT program. While this might not have been a major issue for larger medtech firms, it presented a life-or-death situation for some neurotech startups.

Fortunately, there may soon be relief for breakthrough device designates, coming from two different fronts. First, a bill working its way through the U.S. Congress would mandate that CMS cover breakthrough products within three months of regulatory approval. The bill, called “Ensuring Patient Access to Critical Breakthrough Products Act of 2023,” has bipartisan support, and is sponsored by Rep. Brad Wenstrup of Ohio.

The second lifeline is being thrown by none other than CMS itself. The federal agency recently drafted proposed rulemaking for its Transitional Coverage of Emerging Technologies program, which incorporates many of the same concepts from MCIT. One difference is that the new program would mandate post-market surveillance, requiring vendors to collect data to support their products safety and efficacy even after it receives market approval.

Both solutions have received enthusiastic support from AdvaMed, the largest medical device industry trade group. But the organization has also proposed some modifications to CMS’ vision of the TCET program. One of its biggest pushbacks is its objection to the annual limit of five technologies per year. “Resource constraints should not dictate policy making or beneficiary access to innovative technologies.” AdvaMed wrote in a letter to CMS Administrator Chiquita Brooks La-Sure earlier this month. Short of that, AdvaMed wants CMS to allow multiple vendors to piggyback on a single technology.

The trade organization also expressed concern with CMS’ intention to use a third-party contractor to oversee the evidence review process. “AdvaMed recommends establishing points of contact to facilitate dialogue between the manufacturer and the contractor responsible for conducting the Evidence Preview,” they wrote. “To increase transparency, AdvaMed recommends that CMS publish on its website a list of contractors used for this process.”

Strong support for AdvaMed’s positions came from a recently published article in the Journal of the American Medical Association. The study was authored by Josh Makower and colleagues from the Stanford Byers Center for Biodesign. “Among 281 technologies authorized by the FDA from 2016 to 2019 required new Medicare coverage, the median time to at least nominal coverage was 5.7 years. The time required to establish at least nominal coverage results in uneven beneficiary availability and stretches longer than the time to average FDA approval,” the authors wrote.

We wholeheartedly support AdvaMed’s positions and recommendations for improving the proposed TCET program, and we hope that Congressional action on this helps to expedite the solution.