And Yet Another Whistleblower-Originated False Claims Act Kickback Settlement
By the Constantine Cannon Whistleblower Team
Last Thursday (July 30), the Department of Justice (DOJ) announced that Houston-based Access DX Laboratory — and its former CEO Michael Stewart along with Florida businessman Harold Shatz — agreed to collectively pay $36.4 million to settle allegations they violated the False Claims Act and Anti-Kickback Statute by paying kickbacks and billing Medicare/Medicaid for medically unnecessary genetic testing.[1]
What Was the Nature of the Alleged Kickback Violations By Access DX?
The settlement is just the latest reminder that going after healthcare kickbacks and medically unnecessary testing remains a top DOJ enforcement priority. Indeed, it was just over a month ago when we reported on another DOJ False Claims Act settlement against a laboratory testing company and its owners for allegedly engaging in the very same conduct. In that settlement, Arkansas-based Advanced Pathology Solutions and its owners agreed to pay $30 million to resolve the matter.
The Anti‑Kickback Statute prohibits any kind of financial inducement to induce healthcare referrals for goods or services covered by Medicare/Medicaid. It is designed to ensure medical decisions are in the patient’s best interest and in no way influenced by improper financial incentives. The statute is broad in its application, covering virtually any form of remuneration including cash, meals and entertainment, travel, gifts, free (or below market value) office space — essentially anything of value.
According to the Government, for the two-year period from January 2018 through January 2020, Access DX, Stewart, and Shatz paid kickbacks to marketers in return for referrals of patients for genetic testing and paid telemedicine providers for fake doctors’ orders. They then billed Medicare and Medicaid for genetic testing services resulting from this fraud, much of which was not even medically necessary.
The settlement follows the June 2026 and October 2025 guilty pleas by Stewart and Shatz to conspiracy to defraud the United States and to pay and receive health care kickbacks. In addition to the monetary payout, the settlement also requires Access DX to enter into a five-year Corporate Integrity Agreement where the company will implement a robust compliance program involving employee training and education and a strict review of all arrangements with referral sources.
Does Going After Healthcare Kickbacks Remain A Government Enforcement Priority?
The Access DX settlement follows on the heels of a steady flow of similar settlements where DOJ used the False Claims Act to go after improper healthcare kickbacks. In addition to the recent Advanced Pathology Solutions settlement, a month before that Japan-based Takeda Pharmaceuticals agreed to pay roughly $13.7 million to settle allegations of paying kickbacks to induce prescriptions of Takeda’s Trintellix antidepressant medication.
And as we reported in our listing of the Top 10 False Claims Act Recoveries in 2025, two of the largest False Claims Act settlements last year involved kickbacks. In April 2025, California-based Gilead Sciences agreed to pay $202 million to settle False Claims Act charges of providing financial inducements to physicians to speak at or attend sham medical conferences to induce Gilead prescriptions. And in January 2025, Pfizer subsidiary Biohaven Pharmaceutical agreed to pay roughly $60 million to settle similar charges of providing paid speaking opportunities and expensive meals to induce Biohaven prescriptions.
Strictly enforcing the Anti-Kickback Statute has been a DOJ enforcement priority for years. DOJ Civil Chief Brett Shumate highlighted this priority in announcing the recent settlement:
“Healthcare referrals must reflect the best decision for patients, not the influence of kickbacks. 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.”
U.S. Attorney Theodore Hertzberg (Northern District of Georgia) followed up with his own admonition to future fraudsters thinking about using kickbacks to influence medical decision making: “This settlement sends a clear message that we will not tolerate fraudulent schemes that waste taxpayer dollars and undermine trust in our medical system. We will aggressively pursue any provider or entity that seeks to exploit federal programs through excessive billing and illegal kickbacks.”
What Role Can Whistleblowers Play in Reporting Illegal Kickbacks?
The vast majority of False Claims Act cases are originated by whistleblowers under the qui tam provisions of the statute. These provisions authorize whistleblowers to bring lawsuits on behalf of the Government against those that defraud the government. Successful whistleblowers can receive up to 30% of the Government’s recovery. Over the past thirty years, whistleblowers have received close to $10 billion in awards under the statute and helped the Government secure tens of billions more in recoveries.
Unsurprisingly, a whistleblower originated the Access DX matter. He is Douglas Green, president of a Massachusetts marketing company hired to market genetic testing to Medicare and Medicaid beneficiaries. He will receive a whistleblower award of $7.2 million from the proceeds of the Government’s recovery.
Whistleblowers have been responsible for originating most kickback FCA cases. The explanation is simple. Without someone on the inside who witnesses the misconduct firsthand, it can be very difficult for the Government to uncover the fraud. As Constantine Cannon partner Dan Vitelli notes, “many kickback cases involve sophisticated schemes designed to disguise the financial arrangements used to induce referrals or services.”
He points to the many kickback cases the firm has brought. “The kickback schemes are often carefully constructed and hidden from outside view.” “Without the work of whistleblowers on the inside who expose the misconduct,” Vitelli added, “the Government may never have learned of the kickbacks and taken action to stop them.”
Constantine Cannon Has Substantial Experience Representing False Claims Act Whistleblowers Reporting Kickback Violations
Constantine Cannon has substantial experience representing kickback whistleblowers under the False Claims Act. Most recently, we represented the whistleblower who helped DOJ secure a $34 million settlement against dialysis giant DaVita for allegedly paying physicians for referring patients to DaVita’s dialysis centers. He received an award of roughly 18.5% of the Government’s recovery.
If you would like to learn more about this matter, Constantine Cannon’s long list of False Claims Act successes, or what it means to be a whistleblower more broadly, please do not hesitate to contact us. We will connect you with an experienced member of the Constantine Cannon whistleblower team for a free and confidential consultation.
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[1] See https://www.justice.gov/opa/pr/texas-laboratory-former-ceo-and-florida-businessman-pay-total-364m-settle-allegations.
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