Access DX Laboratory, its former CEO Michael Stewart, and Florida businessman Harold Shatz will 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, according to a July 30 announcement from the U.S. Attorney’s Office for the Northern District of Georgia.
U.S. Attorney Theodore S. Hertzberg said, “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.”
Assistant Attorney General Brett A. Shumate of the Justice Department’s Civil Division said, “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.” Acting Deputy Inspector General for Investigations Miranda L. Bennett of HHS-OIG added, “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… 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.”
The government’s investigation began after a whistleblower filed a complaint alleging that between January 2018 through January 2020 Access DX paid kickbacks to marketers in return for referrals of patients for genetic testing; unbundled billing codes; paid telemedicine providers for false doctors’ orders; and submitted false claims related to genetic tests. Stewart and Shatz pleaded guilty in United States District Court for conspiracy charges related to defrauding the United States through these actions.
The civil settlement resolves a lawsuit filed under whistleblower provisions in U.S. ex rel. Green v. Access DX Lab LLC et al., No. 1:19-cv-2845 (N.D.Ga.). As part of its settlement agreement, Access DX entered into a five-year Corporate Integrity Agreement with HHS-OIG requiring compliance measures such as auditing arrangements with referral sources.
Except where admitted by Stewart or Shatz in their plea agreements, all claims resolved are allegations only without determination of liability.
Under False Claims Act provisions allowing private citizens to bring suit on behalf of the government—and share recovery—whistleblower Douglas Green will receive $7.2 million from this settlement.
The case was handled by Assistant U.S. Attorney Neeli Ben-David along with Senior Litigation Counsel Laurie A Oberembt from DOJ Civil Division with support from HHS-OIG staff.
This year saw creation of an Administration Task Force to Eliminate Fraud alongside establishment of National Fraud Enforcement Division focused on fighting abuse within federal programs—a mission supported by continued enforcement under FCA statutes recovering billions annually while holding violators accountable, according to the official website. The U.S. Attorney’s Office serves as principal federal law enforcement agency across north Georgia—including Atlanta suburbs—covering cases ranging from terrorism threats through human trafficking while collaborating nationally or internationally as needed.