Medicare Proposes Covering Newly Approved Cologuard Test for CRC Detection

The final decision on the proposal will be made only after a 30-day comment period.

Medicare beneficiaries may get speedier coverage for a newly approved screening test for colorectal cancer under a pilot project in which two federal agencies reviewed the product at the same time instead of one after the other.

The Cologuard test, which detects the presence of DNA mutations that may be cancers in the stool, was approved by the Food and Drug Administration this week. The same day, the Centers for Medicare& Medicaid Services issued a proposal to cover the test once every three years in asymptomatic people over age 50 who are at average risk for the disease.

It’s the first time the agencies have undertaken a parallel review, and it could trim up to six months off the time it takes to offer Medicare coverage for a medical device, according to Nancy Stade, deputy director for policy at the FDA’s Center for Devices and Radiological Health in the FDA news release.

Although CMS has proposed covering the test, a final decision won’t be made until after a 30-day comment period.

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Source: Kaiser Health News