A Houston-based genetic testing laboratory, its former chief executive and a Florida businessman have agreed to pay a combined $36.4 million to resolve allegations that they violated the False Claims Act by paying kickbacks and billing Medicare and Medicaid for medically unnecessary genetic testing, the Justice Department announced.
Access DX Laboratory, former CEO Michael Stewart and businessman Harold Shatz reached the settlements to resolve claims that, from January 2018 through January 2020, they paid kickbacks to marketers in exchange for patient referrals for genetic testing, according to the Justice Department. The government also alleged they unbundled billing codes for the tests, paid telemedicine providers for false and fraudulent doctors’ orders, and submitted or caused the submission of false claims for genetic testing.
“Healthcare referrals must reflect the best decision for patients, not the influence of kickbacks,” said Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division, adding that the resolution reflects the department’s commitment to holding both companies and individuals accountable for improper kickback arrangements and claims for medically unnecessary services.
U.S. Attorney Theodore S. Hertzberg for the Northern District of Georgia said the settlement demonstrates that his office will not tolerate fraudulent schemes that waste taxpayer money and undermine trust in the medical system. Acting Deputy Inspector General for Investigations Miranda L. Bennett of the Department of Health and Human Services Office of Inspector General said kickback and medically unnecessary genetic-testing schemes undermine the integrity of the U.S. health care system and increase costs.
As part of the settlement, Access DX entered into a five-year Corporate Integrity Agreement with HHS-OIG requiring auditing and accountability provisions, a robust compliance program, training and education, and a review of arrangements with referral sources, according to the release.
Stewart agreed on June 24 to plead guilty to conspiracy to defraud the United States and to pay and receive health care kickbacks in a case filed in the Southern District of Texas, the department said. Shatz agreed on Oct. 15, 2025, to plead guilty to the same charge in a separate case in that district. Both men also entered into civil False Claims Act settlements in connection with their plea agreements.
The civil case stemmed from a whistleblower lawsuit filed by Douglas Green, president of a Massachusetts marketing company hired to market genetic testing to Medicare and Medicaid beneficiaries. The lawsuit was filed under the False Claims Act’s qui tam provisions, which allow private parties to sue on the government’s behalf and receive a share of any recovery. Green will receive $7.2 million of the total settlement, according to the Justice Department.
The resolution resulted from a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section, and the U.S. Attorney’s Office for the Northern District of Georgia, with assistance from HHS-OIG. Except to the extent admitted by Stewart and Shatz in their plea agreements, the claims resolved through the settlements are allegations only, and there has been no determination of liability.
This article was constructed with the assistance of artificial intelligence and published by a member of The Washington Times' AI News Desk team. The contents of this report are based solely on The Washington Times' original reporting, wire services, and/or other sources cited within the report. For more information, please read our AI policy or contact Steve Fink, Director of Artificial Intelligence, at sfink@washingtontimes.com
The Washington Times AI Ethics Newsroom Committee can be reached at aispotlight@washingtontimes.com.
Please read our comment policy before commenting.