The U.S. Department of Justice Civil Division has officially finalized a $36.4 million civil settlement resolving allegations of illegal kickbacks and fraudulent billing against Houston-based Access DX Laboratory, its former CEO Michael Stewart, and Florida businessman Harold Shatz.
The announcement formalizes the conclusion of a major federal healthcare fraud investigation into medically unnecessary genetic testing billed to Medicare and Medicaid.
Terms of the Finalized Agreement
Under the final terms released by federal prosecutors, the defendants have agreed to pay $36.4 million to resolve civil False Claims Act liability stemming from operations conducted between January 2018 and January 2020.
- Kickbacks for patient referrals: The government alleged that Access DX and its leadership paid financial kickbacks to third-party marketers to recruit Medicare and Medicaid beneficiaries for genetic testing panels.
- Fraudulent telemedicine orders: The defendants paid telemedicine providers to issue false or medically unnecessary physician orders without proper patient evaluation.
- Unbundled billing codes: Access DX systematically unbundled testing codes to bypass federal reimbursement caps and maximize payouts from federal healthcare benefit programs.
Whistleblower Award and Corporate Mandates
The settlement resolves a qui tam whistleblower lawsuit filed by Douglas Green, the president of a Massachusetts marketing firm. As part of the final resolution, Green will receive approximately $7.2 million as his statutory share of the recovery under the False Claims Act.
In addition to the monetary payout, Access DX has entered into a mandatory five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG), requiring independent auditing and strict oversight of all referral arrangements.
While the civil settlement resolves the monetary claims without a formal determination of civil liability, former CEO Michael Stewart and Florida businessman Harold Shatz previously entered guilty pleas to criminal charges of conspiracy to defraud the United States and paying and receiving healthcare kickbacks.
Sources
- DOJ | Texas Laboratory, Former CEO, and Florida Businessman Pay $36.4M to Settle Allegations
- USAO Northern District of Georgia | Access DX Settlement Announcement
- HHS-OIG | Access DX Settlement Details
- Becker ASC Review | Texas Lab, CEO to Pay $36.2M to Settle Allegations
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