Access DX Laboratory, located in Houston, Texas, its former CEO Michael Stewart, and Florida businessman Harold Shatz have agreed to pay a combined $36.4 million to resolve allegations that they violated the False Claims Act.
Federal prosecutors alleged that the laboratory and both men participated in illegal kickback schemes and submitted claims for medically unnecessary genetic testing to Medicare and Medicaid.
According to federal officials, the conduct took place between January 2018 and January 2020. During that timeframe, Access DX, Stewart, and Shatz allegedly paid kickbacks to marketers to secure patient referrals for genetic testing. The government also alleged that they unbundled billing codes, paid telemedicine providers for false doctor orders, and submitted fraudulent claims to federal healthcare programs.
“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.”
As part of the settlement, Access DX agreed to a five-year Corporate Integrity Agreement with the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). Under the agreement, the company must establish an updated compliance program, conduct employee training, and undergo regular reviews of its referral arrangements.
Both individuals involved face criminal charges alongside the civil settlements. Stewart agreed on June 24 to plead guilty to conspiracy to defraud the United States and to pay and receive healthcare kickbacks. Shatz agreed to plead guilty to the same charge on Oct. 15, 2025. Both criminal cases were filed in the U.S. District Court for the Southern District of Texas.
“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.”
The allegations originally came to light through a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by Douglas Green, the president of a Massachusetts marketing company that had been hired to market genetic testing to beneficiaries. Under federal law, private citizens may file lawsuits on behalf of the government and share in any financial recovery. Green will receive $7.2 million from the overall settlement.
“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 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 a statement to the Tampa Free Press Friday, Access DX said, “Access DX welcomes today’s announcements by the DOJ as part of their ongoing commitment to identifying and remediating all forms of waste, fraud, and abuse that harm taxpayers and clinical quality. Today’s release notes that Access DX has been fully cooperating with an ongoing investigation under seal, for a period dating back more than five years. As noted in the release, there is no finding by DOJ against Access DX, nor has Access DX admitted to any wrongdoing as a part of the resolution. For the last three years, Access DX has fully complied with all its obligations under its agreement. Access DX is now entering its fourth year of its compliance program under its agreement, and reiterates its continued commitment to clinical and operational excellence.”
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