US Justice Department Secures $42.9M in Healthcare Fraud Settlements with Access DX and Orchard Laboratories

The U.S. Department of Justice announced two major False Claims Act settlements targeting healthcare fraud. Access DX Laboratory agreed to pay $36.4 million to resolve allegations that its former CEO Michael Stewart and businessman Harold Shatz paid kickbacks for patient referrals, used unbundled genetic‑testing billing codes, and submitted claims for medically unnecessary testing to Medicare and Medicaid between 2018 and 2020. The settlement also includes a five‑year Corporate Integrity Agreement with the HHS Office of Inspector General.

Separately, Orchard Laboratories Corporation settled for $6.5 million over false billing for over‑the‑counter COVID‑19 tests that were never requested or delivered to Medicare beneficiaries. The case was investigated by the FBI, the U.S. Attorney’s Office for the Eastern District of Michigan, and the HHS Office of Inspector General. Both settlements aim to reinforce compliance and protect taxpayer‑funded health programs.