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GenomeDx to pay $1.99 million to resolve allegations of False Claims

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GenomeDx Biosciences
America   GenomeDx Biosciences

The Justice Department announced that GenomeDx Biosciences Corp. (GenomeDx) has agreed to pay $1.99 million to resolve allegations that it violated the False Claims Act by submitting claims to Medicare for the Decipher post-operative genetic test for prostate cancer patients.

GenomeDx is a genetic testing laboratory headquartered in Vancouver, British Columbia, with operations based in San Diego.

The United States alleged that GenomeDx knowingly submitted claims for the Decipher test to Medicare between September 2015 and June 2017 that were not medically reasonable and necessary because 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 settlement resolves allegations originally brought in a lawsuit filed under the /qui tam /or whistleblower provisions of the False Claims Act, which allow private parties to bring suit on behalf of the government and to share in any recovery. The whistleblowers will receive $348,316.50 from the False Claims Act recovery.

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