Abstract
GenomeDx Biosciences has agreed to pay the U.S. federal government $1.99 million to settle allegations that it submitted false claims to Medicare for the Decipher post-operative genetic test for prostate cancer patients.
The federal government alleged that GenomeDx violated the False Claims Act by knowingly submitting claims for the Decipher test to Medicare between September 2015 and June 2017 that were not medically reasonable and necessary.
Authorities reached that conclusion after determining that the prostate cancer patients did not have risk factors necessitating the test, including pathological stage T2 disease with a positive surgical margin, pathological stage T3 disease, or rising Prostate-Specific Antigen (PSA) levels after an initial PSA nadir, the U.S. Department of Justice said.
The Decipher test is designed to predict the probability of metastasis after surgery, as well as provide an independent assessment of tumor aggressiveness that differs from information provided by Gleason score or PSA.
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