ARTICLE SUMMARY:
Medtech groups formally respond to CMS’ RAPID proposal for regulatory-reimbursement alignment. Excerpted from Pathways Picks October 14: RAPID Response, Notified Body Needs, CDRH Retirement, and More.
CMS heard from more than 100 device firms, innovators, and other stakeholders in recent days about its plan for a Regulatory Alignment for Predictable and Immediate Device (RAPID) Coverage Pathway. Written feedback was due October 13 for the August 11 proposal, and many are pressing the agency to expand the scope of program. The RAPID pathway would task FDA and CMS to engage with manufacturers prior to the company’s investigational device exemption (IDE) trial, initiating a process promising FDA authorization and a national Medicare coverage proposal on the same day.
Multiple individual companies currently conducting pivotal trials for Breakthrough Devices weighed in, urging CMS to add a transitional path allowing devices like theirs to participate in RAPID even if they have already launched a pivotal study. CSA Medical, for instance, argued in October 7 comments that the fact it has already launched a pivotal trial for the firm’s RejuvenAir Metered CryoSpray for chronic obstructive pulmonary disease “should not, by itself, preclude CMS from evaluating whether the existing evidence is sufficient to support Medicare coverage or identifying any remaining evidence needs that could be addressed in a practical and least burdensome manner.”
There was also a broader push for program expansion. In October 8 comments, AdvaMed pressed CMS to reverse its proposals to exclude all IVDs, Class II devices not enrolled in the TPLC Advisory Program (TAP), and products that don’t require an IDE submission to start a study. They also argue that CMS will need more resources to implement the program. “To ensure the long-term sustainability of the RAPID pathway, additional and adequate resources for the CMS Coverage and Analysis Group (CAG) are essential to ensure that all parties – manufacturers, FDA, and CMS – can fully engage in meaningful coordination through the RAPID process,” the trade group argues.
The Medical Device Manufacturers Association (MDMA) made similar calls for more flexible eligibility in its October 12 letter. MDMA also urged CMS to provide greater assurances that participation in RAPID won’t substantially add to the length and burden of the FDA development and review processes.