Notable Success for Parallel Review Program, but Uncertainty about Program’s Future

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On Aug. 11, Cologuard became the first technology to receive a simultaneous FDA approval and proposed Medicare national coverage determination (NCD) through the FDA-CMS Parallel Review program.
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In the draft NCD, CMS proposes covering Cologuard once every three years for asymptomatic, average-risk beneficiaries between the ages of 50-80.

Cologuard is the first noninvasive, stool-based DNA test approved for detecting colorectal cancer (CRC). A positive Cologuard test indicates a need for colonoscopy to identify, or to rule out, CRC. Cologuard is the inaugural participant of the Parallel Review pilot program, initiated in October 2011. The program allows for concurrent review of a medical technology for pre-market approval and Medicare coverage, which reduces the NCD timeline by about six months. Currently, Medicare does not cover stool-based DNA tests. If finalized, this decision would represent a significant coverage expansion.

Cologuard’s positive experience with Parallel Review demonstrates that the pathway could offer a productive commercialization approach for technologies that must overturn a negative NCD to obtain Medicare coverage. However, CMS’ limited bandwidth has and will continue to be an obstacle for the Agency’s ability to accept other technologies into the program. Since Parallel Review’s launch in 2011, there have been only two participants, so while FDA/CMS issued a notice extending the pilot program to December 2015, it is unclear if the Agencies will be able to conduct parallel reviews for other technologies by the end of 2015.

In the proposed NCD, while CMS notes that there is insufficient evidence regarding the appropriate screening interval for stool-based DNA tests, it did not implement coverage with evidence development (CED) requirements. Rather, CMS states that FDA will address this evidence gap in their post-approval study for Cologuard, and that CMS will reevaluate the screening interval after completion of the study and modify the NCD as needed. CMS’ decision not to employ CED for Cologuard is surprising given that three of the last ten NCDs have ended in CED.

Finally, the U.S. Preventive Task Force Service (USPSTF) is currently updating its 2008 recommendation for CRC screening, which predates Cologuard, and does not recommend stool-based DNA testing as a method to screen for CRC. The USPSTF’s update will be another critical market access milestone for Cologuard, because USPSTF recommended services (Grade A or B) must be covered with zero cost sharing by commercial payers.

CMS is currently accepting public comments on the draft NCD until Sept. 10. The Agency expects to release a final decision by November 9, 2014.

View FDA’s ruling.

View CMS’ proposed coverage.

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