Parallel Review Here to Stay

Putting to rest some speculation about what the initiative's future will be, a CMS leader confirmed today that the Parallel Review program will be made permanent.

Calling Parallel Review a "really high priority," Kate Goodrich, MD, MHS, director of the Center for Clinical Standards and Quality at CMS, told an audience today at the 2016 Medical Device Manufacturers Association annual meeting that CMS anticipates making Parallel Review permanent soon.

"We anticipate putting out a notice to make [Parallel Review] permanent soon," Goodrich said.

The initiative, which started as a two-year pilot program in 2011, allows medical device companies to work with FDA and CMS simultaneously to reduce the amount of time between FDA approval and CMS reimbursement coverage. Securing reimbursement is a major concern for medical device companies, with many executives calling it the biggest hurdle to commercialization. It can often take several months or even years to secure and can make or break a company. The idea behind Parallel Review is that conducting the regulatory and reimbursement process simultaneously can give a device a better chance of success.

The pilot was extended for another two years, until December 18, 2015. The Cologuard colon cancer screening test from Exact Sciences was famously the first product through the program. The test received FDA approval and a proposed CMS NCD on the same day in August 2014. 

"We've put a call out to private payers to say, 'If you're interested in this, let us know,'" CDRH director Jeffrey Shuren, MD, JD said. He added that there has been a lot of interest and Parallel Review is still gathering names of payers who may participate.Parallel Review is managed by CMS and CDRH's Payer Communication Task Force, and is being expanded to add private payers into the mix. Speaking at the MDMA meeting Wednesday, Shuren explained that the program is gauging interest from private insurers who are interested in participating. Then, companies sponsoring a new medical device will be able to request which private payers they want sitting in on the discussions.

[Image courtesy of SALVATORE VUONO/FREEDIGITALPHOTOS.NET.]