A major new white paper has been released by the Tufts CEVR - the Center for the Evaluation of Value and Risk in Health. It's titled "Medicare Coverage of Emerging Technologies: Challenges and Opportunities." Authors are Sean Tunis, Peter Neumann, James Chambers, and Nola Jenkins.
Download the paper from here:
See also a March 2022 paper by Stanford Biodesign, Ruggles et al., on the need for Medicare coverage for innovative technologies, here, here. And CMS is updating its rules and requirements for Coverage with Evidence Developments, here and here. I posted a five minute video update of the CMS events in mid-September, on YouTube, here with some links to sources like an AdvaMed white paper on the topic.
Back to the CEVR 33-page whitepaper released today, they highlight seven recommendations.
- Assess existing programs thoroughly.
- CMS CMS-specific processes for innovative technologies.
- Balance the interest of multiple stakeholders [with conflicting interests].
- Expand the expertise and bandwidth in CMS personnel for this topic.
- Clarify what "evidence for Medicare population" means.
- Expand the use of real world evidence.
- Consider a "CMS opt out option for FDA approved devices that requires limited CMS engagement."