AdvaMed asks CMS to widen RAPID eligibility as comments close October 13

Comments on the RAPID coverage pathway close October 13. CMS published the proposed notice at 91 Fed. Reg. 51710 on August 11, and paused TCET for new candidates the same day.

RAPID would post a proposed national coverage determination on the day FDA authorizes an eligible device, then take comments for 30 days. A final NCD could follow 60 days later for Class II devices and 90 days later for Class III. Eligibility is narrow. A Class II breakthrough device has to be in FDA's TAP program and heading for a De Novo request. A Class III breakthrough device has to be heading for a PMA, in or out of TAP. Both have to be at the IDE pre-submission stage, with a study that enrolls Medicare beneficiaries and measures outcomes FDA and CMS agree on.

In vitro diagnostics are excluded, and CMS says they generally stay with the Medicare administrative contractors. AdvaMed filed on October 9 and called the pathway a positive step. It asked CMS to make more breakthrough devices eligible and to let diagnostics participate. It also asked for firm NCD timelines and for transition protection for technologies planned under the earlier pathways.

The eligibility gate sits at IDE pre-submission, so the coverage conversation now starts before the IDE study is designed. With TCET closed to new candidates, a company that misses that gate has nothing to fall back on.