Bluewater Toxicology, LLC, a clinical laboratory in Mount Washington, Ky., has agreed to pay $1,252,403.40 to resolve civil allegations that it violated the False Claims Act. According to the settlement agreement, the Unites States alleged three issues relating to claims for urine drug testing services that Bluewater submitted to Medicare, Kentucky Medicaid, Indiana Medicaid, TRICARE, and CHAMPVA.
First, the United States alleged that Bluewater submitted claims that mispresented the number of drug classes tested. Specifically, the United States contended that from January 2016, through September 2018, Bluewater submitted claims for definitive urine drug tests of 22 or more drug classes. The United States alleged that these claims were false because Bluewater tested for fewer than 22 drug classes. By billing as if they tested for a greater number of classes, Bluewater secured higher reimbursements to which it was not entitled.
Second, the United States alleged that from January 2016, through December 2017, Bluewater submitted certain claims without sufficient documentation to support the treating medical physician’s intent to order the test that was billed. By billing for these tests, Bluewater again secured reimbursements to which it was not entitled.
Finally, the United States alleged that Bluewater billed Medicare for specimen validity testing, a quality control process used to analyze a urine specimen to ensure that it has not been diluted or adulterated. Since January 2014, Medicare’s guidance has stated that specimen validity testing should not be separately billed to Medicare. The United States alleged that Bluewater nonetheless submitted claims to Medicare for specimen validity testing during the period October 2014 to May 2016.