Access DX Laboratory, located in Houston, Texas, its former CEO Michael Stewart, and Florida businessman Harold Shatz, have each entered into settlements and will pay a combined total of $36.4 million to the United States to resolve allegations that they violated the False Claims Act (FCA) by paying kickbacks and billing Medicare and Medicaid for medically unnecessary genetic testing.

The United States alleged that, from January 2018 through January 2020, Access DX, Stewart, and Shatz paid kickbacks to marketers in return for referrals of patients for genetic testing, unbundled billing codes for genetic testing, paid telemedicine providers for false and fraudulent doctors’ orders, and submitted and 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. “This resolution demonstrates the Department’s commitment to hold accountable both corporations and individuals who profit from improper kickback arrangements and who burden federal healthcare programs with claims for medically unnecessary services.”

“This settlement sends a clear message that we will not tolerate fraudulent schemes that waste taxpayer dollars and undermine trust in our medical system,” said U.S. Attorney Theodore S. Hertzberg for the Northern District of Georgia. “We will aggressively pursue any provider or entity that seeks to exploit federal programs through excessive billing and illegal kickbacks.”

“Kickbacks and medically unnecessary genetic testing schemes not only drain taxpayer-funded federal health care programs, but undermine the integrity of our U.S. health care system and drive up health care costs for all of us,” said Acting Deputy Inspector General for Investigations Miranda L. Bennett of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). “HHS OIG will continue to work with our law enforcement partners to aggressively pursue health care fraud and protect Medicare, Medicaid, and the people who rely on them.”

In connection with its settlement, Access DX entered into a five-year Corporate Integrity Agreement (CIA) with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). The CIA requires Access DX to implement auditing and accountability provisions, including implementation of a robust compliance program, training and education requirements, and a review of arrangements with referral sources.

On June 24, Stewart agreed to plead guilty to conspiracy to defraud the United States and to pay and receive health care kickbacks in violation of 18 U.S.C. § 371. United States v. Stewart, Case No. 4:22-cr-328 (S.D. Tex.). On Oct. 15, 2025, Shatz agreed to plead guilty to conspiracy to defraud the United States and to pay and receive health care kickbacks in violation of 18 U.S.C. § 371. United States v. Shatz, No. 4:24-cr-330 (S.D. Tex.). Both men entered into civil FCA settlements at the time of their pleas.

The civil settlements include the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by Douglas Green, president of a Massachusetts marketing company hired to market genetic testing to Medicare and Medicaid beneficiaries. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery.  The qui tam case is captioned U.S. ex rel. Green v. Access DX Lab LLC, et al., No. 1:19-cv-2845 (N.D. Ga.). The settlements provide for the whistleblower to receive a $7.2 million share of the total settlement amount. 

The resolution obtained in this matter was the result of a coordinated effort between the Justice Department’s Civil Division, Commercial Litigation Branch, Fraud Section, and the United States Attorney’s Office for the Northern District of Georgia, with assistance from HHS-OIG.

The matter was handled by Fraud Section Senior Litigation Counsel Laurie A. Oberembt of the Justice Department’s Civil Division and Assistant U.S. Attorney Neeli Ben-David for the Northern District of Georgia.

The investigation and resolution of this matter illustrate the government’s emphasis on combating healthcare fraud.  One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement, can be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).

This year the Administration launched the Task Force to Eliminate Fraud and the National Fraud Enforcement Division to enhance the Administration’s war on fraud, waste, and abuse in federal programs. When unscrupulous actors exploit these programs for their own financial gain, they defraud the government, harm the people these programs are designed to aid and protect, and undermine American businesses that play by the rules. The Civil Division’s FCA enforcement plays a critical role in combatting such fraudulent schemes, recovering billions of dollars for the American taxpayers, and holding wrongdoers accountable. FCA matters will continue to be on the forefront of the battle against fraud, and the Civil Division’s FCA work will support and advance the mission of the Task Force to Eliminate Fraud and the National Fraud Enforcement Division.

Except to the extent admitted by Stewart and Shatz in their plea agreements, the claims resolved by the settlement are allegations only and there has been no determination of liability.