
BioReference Health LLC, a prominent clinical laboratory service provider, and its parent company OPKO Health Inc. have agreed to pay $704,349 to resolve allegations of submitting false claims to federal healthcare programs. The settlement comes after the companies were accused of billing for medically unnecessary laboratory tests, specifically complete blood count (CBC) tests with automated white blood cell (WBC) differential counts, between January 2012 and March 2023.
The allegations stem from BioReference’s practice of performing and billing for the more expensive CBC with WBC differential tests when medical providers had only ordered the less costly CBC tests without the WBC differential. This resulted in fraudulent claims submitted to federal healthcare programs, including Medicare, for tests that were not medically necessary.
The settlement was announced by the U.S. Department of Justice, highlighting the government’s ongoing commitment to safeguarding federal healthcare programs and taxpayer funds.
“Healthcare 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. “This settlement demonstrates our commitment to protecting the integrity of federal health care programs.”
The United States alleges that from 2012 until 2023, BioReference, one of the largest clinical laboratories in the country, routinely performed the unnecessary, more expensive tests and billed federal healthcare programs for them. This scheme, the Justice Department said, wasted taxpayer money and inflated healthcare costs for all Americans.
U.S. Attorney David C. Weiss for the District of Delaware emphasized the impact of such fraudulent schemes, saying, “BioReference allegedly profited by fraudulently performing and billing the federal government for unreasonable and unnecessary lab tests. My office will vigorously enforce anti-fraud statutes like the False Claims Act to combat such fraud and abuse of our healthcare system.”
The settlement follows a lawsuit filed by a whistleblower under the False Claims Act’s qui tam provisions, which allow private individuals to file suit on behalf of the government and potentially share in any recovery. The whistleblower, Omni Healthcare Inc., will receive $112,694 of the settlement amount for its role in bringing the allegations to light.
The settlement also highlights the continued role of the Department of Health and Human Services Office of Inspector General (HHS-OIG) in investigating fraud and abuse in the 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 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.”
This resolution marks a significant step in holding healthcare providers accountable for their billing practices. The settlement was reached through a coordinated effort between the Civil Division’s Commercial Litigation Branch, Fraud Section, and the U.S. Attorney’s Office for the District of Delaware, with assistance from HHS-OIG.
As part of the settlement, BioReference Health, a subsidiary of OPKO Health, will pay $704,349 to resolve the claims. The case serves as a reminder of the government’s commitment to protecting healthcare integrity and ensuring that taxpayer funds are used appropriately.
For the whistleblower, this case underscores the importance of holding companies accountable for fraudulent practices. The qui tam provisions of the False Claims Act continue to encourage individuals to come forward with information about fraud in the healthcare industry.