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FDA and CMS Permanently Establish Parallel Review

On October 24, 2016, the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register announcing the indefinite extension of the Parallel Review Program. The agencies’ decision was based on “positive experience” from the Parallel Review Pilot Program, which has allowed manufacturers to conduct a single pivotal study to meet both agencies’ requirements and shorten the time to obtaining both FDA approval and a CMS national coverage determination (NCD).  As with the pilot program, the permanent program will accept no more than five candidates a year.

FDA and CMS established Parallel Review as a pilot program in 2011.  Under the program, FDA and CMS concurrently review FDA premarket review submissions and CMS NCDs for certain medical devices.  To qualify for Parallel Review, a medical device must:

  • Require an original or supplemental application for premarket approval (PMA) or an FDA de novo request; and

  • Fall within the scope of Medicare Part A or Part B.

Several device manufacturers have already utilized the Parallel Review process.  In August 2014, Exact Sciences won PMA approval from FDA and a draft NCD from CMS for its colorectal screening test, Cologuard.  Kevin Conroy, the CEO of Exact Sciences, was quoted as saying, “I would go so far as to say that I don’t know how from an investment standpoint we could have done this without parallel FDA approval and Medicare coverage and payment.”

Though the parallel review program has potential advantages, it may not be appropriate for all devices. Experts have noted that parallel review might not be advantageous if the new product would be covered under an existing code or likely would receive coverage under a Local Coverage Determination (LCD).  Further, the data often required to obtain a favorable NCD may come from post-approval studies that may not be available during FDA approval.  FDA and CMS also use different criteria to conduct different types of review, so there is a chance that Parallel Review could blur standards to result in an unfavorable decision.

Since 2011, only two manufacturers, other than Exact Sciences, have been known participants in Parallel Review.

  • Medtronic (SymplicityTM Renal Denervation System): In 2013, Medtronic announced that FDA and CMS had accepted SymplicityTM into their parallel review program.

  • Foundation Medicine (FoundationOne®): In August 2016, FDA and CMS accepted FoundationOne® for Parallel Review.

Despite the program’s relatively low participation to date, it may be expanding.  FDA was recently quoted as stating that the program had received 60 inquiries and 26 applications.

For manufacturers planning to develop new or complex devices that could benefit from both FDA approval and a NCD, they should consider the risks and benefits of the Parallel Review Program.

Elizabeth Guo is co-author of this article. 

© 2022 Covington & Burling LLPNational Law Review, Volume VI, Number 305
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About this Author

Scott Danzis, Food and drug attorney, Covington Burling
Partner

Scott Danzis is a partner in the firm’s Food & Drug and Health Care practice groups. His practice focuses on the regulation of medical devices and diagnostics. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements...

202-662-5209
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