Original from: 360dx

The US Attorney's Office for the Northern District of California said earlier this week that cancer testing company Guardant Health has agreed to settle allegations that it knowingly violated the False Claims Act and regulations of the Defense Health Agency.

Under the settlement, Guardant, which specializes in liquid biopsy genomic tests, will pay $913,932.93 to settle the FCA allegations and $31,082.00 in an administrative settlement with DHA.

The alleged violation stems from Guardant's arrangements with a Texas physician to hire friends and family members after which the doctor's test orders increased significantly.

The US argued that Guardant has submitted claims to and received payments from Medicare for clinical laboratory services that had been referred to Guardant by the physician in violation of the Physician Self-Referral Law, or Stark Law. The US further alleged that Guardant knowingly submitted or caused the submission of false claims to Medicare Part B and to TRICARE for tests ordered by the physician during the relevant time period.

According to the US attorney's office, Guardant took a number of significant steps entitling it to credit for cooperating with the government, including voluntarily disclosing the conduct to the US Department of Health and Human Services Office of the Inspector General (HHS-OIG). 

The company "took prompt and substantial remedial measures," the office said in a press release. These include stopping its billing to federal healthcare programs for tests ordered by the physician in question and terminating the physician’s family member’s employment.

“Illegal referrals and incentives undermine the integrity of our federal healthcare programs,” Acting Special Agent in Charge Jeffrey McIntosh of the HHS-OIG said in a statement.

The US attorney's office added that the claims resolved by the settlement are allegations only, and there has been no determination of liability on Guardant's part.

Source: Guardant Health Agrees to Pay Over $900K to Resolve Allegations of False Claims for Lab Tests