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, based on small tissue samples like those routinely archived or stored by pathology laboratories.

Decipher measures the expression levels of 22 RNA biomarkers involved in multiple biological pathways across the genome that are associated with aggressive prostate cancer. The test then uses the expression of these biomarkers to calculate the probability of clinical metastasis within 5 years of radical prostatectomy surgery.

GenomeDx is a genetic testing laboratory headquartered in Vancouver, BC, Canada, with additional operations in San Diego. 

According to GenomeDx, Decipher has been validated in over 2,000 patients in clinical studies with key US cancer centers and centers of excellence.

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—two GenomeDx employees—will receive $348,316.50, the U.S. Justice Department said.

“We commend the two employees of GenomeDx who had the courage to come forward and work with investigators,” Robert S. Brewer, Jr., United States Attorney for the Southern District of California, said yesterday in a statement. “We are committed to protecting the integrity of the Medicare program and will hold health care providers accountable under the False Claims Act when they engage in improper billing.”

The U.S. Attorney’s Office for the Southern District of California joined the Civil Division of the Department of Justice, the Department of Health and Human Services Office of Inspector General, and the FBI in conducting the investigation that led to the federal charges.

The case is United States ex rel. La Fleur et al. v. GenomeDX Biosciences Corp., No. 17-CV-1959 (S.D. Cal.).  

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