Justice Department Finalizes $36.4 Million False Claims Act Settlement With Houston's Access DX Laboratory

The U.S. Department of Justice (DOJ) 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:

• Corporate Integrity Agreement (CIA): Access DX has entered into a mandatory five-year compliance agreement with the Department of Health and Human Services Office of Inspector General (HHS-OIG), requiring independent auditing and strict oversight of all referral arrangements.
• Criminal Admissions: 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/receiving healthcare kickbacks.

Why This Matters: The Access DX settlement is one of the larger DOJ Civil Division healthcare fraud recoveries of 2026, and the $7.2 million whistleblower award signals the government's continued reliance on qui tam relators to surface laboratory fraud. The five-year CIA also means Access DX will operate under a microscope until 2031, a strong deterrent signal to other labs still using third-party marketer kickback models.