A pilot program that allows devicemakers to simultaneously gain U.S. FDA approval and Medicare coverage may expand to evaluate device classes, rather than individual products, when it becomes permanent at the end of the year.

The parallel review pilot program operates on a device-by-device basis. However, the Centers for Medicare & Medicaid Services’ national coverage decisions traditionally apply to device classes, rather than specific products. The most likely way to fix the mismatch would be to expand the program so that coverage decisions reached through parallel review would stand for all similar products, says Murray Sheldon, associate director for technology and innovation in the FDA’s Center for Devices and Radiological Health.

Early Meetings Encouraged

Manufacturers interested in pursuing a parallel review path should meet with the FDA and CMS during the pre-IDE stage. While candidates conducting early feasibility studies may be considered, the “sweet spot” is right before a pivotal trial launches, FDA-CMS liaison Rochelle Fink says. Devices subject to parallel review must be PMA or de novo eligible; 510(k) products cannot participate.

The goal of the early meetings is to ensure that the trial design incorporates a representative sample of CMS beneficiaries, Fink explains. “The worst that can happen is that a manufacturer gets through the FDA review process, but then CMS says, ‘great, this works on 40-year-olds, but what about our 65-year-olds?’ and asks for more trial data,” she says. A manufacturer that works with CMS from the beginning can avoid these setbacks by knowing what endpoints would be needed for CMS to consider coverage.

CMS’ staffers may not always be available for presubmission meetings due to resource constraints, Fink admits. When that happens, the FDA will give the devicemaker materials on CMS’ NCD requirements and stress the importance of testing products on Medicare recipients.

CMS will devote whatever resources it has to ensure that devices can complete parallel review, says Tamara Syrek Jensen, director of the agency’s coverage and analysis group. She adds that CMS is trying to be flexible regarding information requirements on parallel review products.

Sheldon and Fink, who spoke during a Tuesday session at the FDLI annual conference, stressed that the review will remain voluntary after the pilot phase ends on Dec. 18 — meaning CMS won’t get involved in the presubmission process without a manufacturer’s explicit request. Fink acknowledged that some devicemakers may not think a national coverage determination is appropriate for their product.

The agencies plan to launch a parallel review website soon. Questions may be directed to parallel-review@fda.hhs.gov. — Elizabeth Orr