Source: United States Attorneys General 3
BioReference Health LLC, formerly known as BioReference Laboratories Inc. (BioReference) and OPKO Health Inc. (OPKO), have agreed to pay $704,349 to resolve alleged violations of the False Claims Act arising from BioReference’s submission of claims for laboratory tests that had not been ordered by a patient’s provider. OPKO is a Delaware Corporation. BioReference, a subsidiary of OPKO, is headquartered in New Jersey and is one of the largest clinical laboratories in the United States.
The United States alleged that BioReference and OPKO knowingly submitted false claims to federal healthcare programs for complete blood count (CBC) with automated white blood cell (WBC) differential laboratory tests that were not medically necessary. Specifically, the United States alleged that, from Jan. 1, 2012, until March 1, 2023, BioReference and OPKO routinely performed more expensive CBC with WBC differential tests when, in fact, medical providers had ordered less expensive CBC with no WBC differential tests, and then billed federal healthcare programs for the more expensive and medically unnecessary tests.
“Health care providers are expected to provide and bill only for services that are medically necessary,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “Today’s settlement demonstrates our commitment to protecting the integrity of federal health care programs and the taxpayer funds that support them.”
“BioReference allegedly profited by fraudulently performing and billing the federal government for unreasonable and unnecessary lab tests,” said U.S. Attorney David C. Weiss for the District of Delaware. “Schemes like these waste taxpayer money and raise healthcare costs for all Americans. My office will vigorously enforce anti-fraud statutes like the False Claims Act to combat such fraud and abuse of our healthcare system.”
“Laboratory companies have a responsibility to perform the specific testing requested by physicians’ orders,” said Special Agent in Charge Maureen R. Dixon of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “HHS-OIG is committed to working with the Justice Department to investigate allegations of inappropriate insurance claims and to safeguard the integrity of our federal health care programs.”
The settlement stems from allegations originally brought in a lawsuit filed in the District of Delaware by a whistleblower under the qui tam provisions of the False Claims Act, which allow private parties, known as relators, to bring suit on behalf of the government and to share in any recovery. In connection with today’s announced settlement, the relator will receive $112,694 of the recovery. The qui tam case is captioned United States ex rel. Omni Healthcare Inc. v. OPKO Health, Inc. and BioReference Laboratories Inc., Civil Action No. 19-1670 (DDE).
This settlement was the result of a coordinated effort between the Civil Division’s Commercial Litigation Branch, Fraud Section and U.S. Attorney’s Office for the District of Delaware with assistance from HHS-OIG. Trial Attorney Claire L. Norsetter of the Justice Department’s Civil Division and Assistant U.S. Attorney Shamoor Anis for the District of Delaware handled the matter.
The claims resolved by the settlement are allegations only. There has been no determination of liability.