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CMS Issues Final Payment Decision for Exact Sciences' Cologuard Test

NEW YORK (GenomeWeb) – The Centers for Medicare & Medicaid Services has issued its final payment decision for Exact Sciences' Cologuard test and will reimburse providers $502 per test, the firm announced today.

It is the exact reimbursement price the Madison, Wis.-based molecular diagnostics firm had proposed to CMS, discounted from the list price of $600.

The noninvasive colorectal cancer test is the first and only US Food and Drug Administration-approved test screening DNA from stool samples, the firm said in a statement.

In August, the Mayo Clinic became the first healthcare system to offer the test, and on Nov. 6, the American Cancer Society updated its national guidelines on colorectal cancer prevention and early detection to reflect the commercial availability of the test. 

The final payment decision follows an evaluation by the agency as part of a joint FDA and CMS parallel review program. Cologuard is the first technology to gain approval through this program.

In Tuesday afternoon trade on the Nasdaq, shares of Exact Sciences were up around 3 percent at $25.08.