The settlement agreement will include a denial of any wrongdoing by HDL, the laboratory, based in Richmond, Va., said in a statement.
“We wish to make it clear that HDL Inc. has worked cooperatively with the Department of Justice since the inception of its investigation of various diagnostic laboratory industry practices, many of them common within the industry,” HDL said in the statement. “We look forward to concluding a settlement with the Department in the very near future that will enable our company to avoid potentially expensive and protracted litigation and allow us to move ahead with our important work of helping improve the health of millions of Americans.”
A company spokesman said he was not certain about the dollar amount of the settlement, but the Wall Street Journal reported that HDL will pay the government nearly $50 million, according to unnamed sources familiar with the issue. A spokeswoman for the Justice Department declined to comment on the matter Tuesday.
HDL will continue to be eligible for participation in federal health programs and will further develop and strengthen its compliance program as part of a five-year corporate integrity agreement with HHS' Office of Inspector General, according to HDL.
The "payment of fees to physicians to help cover costs of performing specimen processing and handling services was a long-standing, industry-wide practice," an HDL spokesman said Tuesday.
But HDL stopped making such payments in June 2014 when the HHS Office of Inspector General issued a special fraud alert saying they presented "a substantial risk of fraud and abuse under the anti-kickback statute," according to the company.
HDL blood tests help doctors detect cardiovascular risk by looking at biomarkers.
Lisa Schencker covers legal issues and enforcement agencies. Before joining Modern Healthcare in 2014, she was an education reporter for the Salt Lake Tribune and before that wrote for the Bakersfield Californian and the Scranton (Pa.) Times-Tribune. She has bachelor’s and master’s degrees in journalism from the University of Illinois at Urbana-Champaign.Follow on Twitter