Marketers and Physicians in Five States Agree to Pay over $1.5 Million to Settle Laboratory Kickback Allegations

NEWARK, N.J. – Two laboratory marketers, their marketing companies, and five doctors have agreed to pay over $1.5 million to resolve allegations of False Claims Act allegations of involvement in laboratory kickback schemes in violation of the Anti-Kickback Statute.

“The kickbacks resulted in the submission of fraudulent laboratory testing claims to Medicare. Clinical laboratories, marketing companies, and health care practitioners are on notice that kickback arrangements in any form are not acceptable. No matter how they are named – as a ‘consulting fee,’ ‘commission,’ or otherwise – or whether they are paid through intermediaries, kickbacks undermine the integrity of medical decision making and have no place in our healthcare system. Today’s agreement is yet another example of my office’s commitment to enforcing the False Claims Act and the Anti-Kickback Statute and protecting Medicare from shelling out taxpayer money for reimbursements tainted by improper kickbacks.”  

“Kickbacks can harm taxpayer-funded healthcare programs, distort the market for healthcare services and improperly influence healthcare providers’ medical decisions,” Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division, said. “We will continue to pursue those involved in illegal kickback schemes, including marketers, doctors, and medical practices.”

“Certain violations of the Anti-Kickback Statute can induce medically unnecessary testing and inappropriately steer medical tests to providers who may not return timely or quality results,” Special Agent in Charge Naomi D. Gruchacz of the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG), said. “We will continue to work with our law enforcement partners to seek resolutions and effect change to preserve the integrity of the federal health care system.”

The Anti-Kickback Statute prohibits offering, paying, soliciting, or receiving remuneration to induce referrals of items or services covered by Medicare and other federally funded healthcare programs. The Anti-Kickback Statute is intended to ensure that medical providers’ judgments are not compromised by improper financial incentives and are instead based on the best interests of their patients.

The Anti-Kickback Statute holds accountable parties on both sides of an impermissible kickback arrangement. The settlements announced today resolve allegations that laboratory marketers and their companies paid or conspired to pay kickbacks to doctors, and that doctors and their companies received kickbacks in return for laboratory referrals. The alleged kickbacks resulted in the submission of false or fraudulent laboratory testing claims to Medicare in violation of the False Claims Act.

The Marketer Settlements

George Carralejo of Yorba Linda, California, and his marketing company, OC Genetic Consultants Inc., agreed to pay $400,000 to resolve allegations that they entered into two illegal schemes to pay kickbacks to doctors for laboratory referrals. From August 2020 to September 2021, Carralejo and his company allegedly conspired with a South Carolina marketer, Ralston Health Group Inc., to pay kickbacks disguised as consulting and medical director fees to a doctor in Houston, Texas. Carralejo and his company paid the kickbacks in order to induce the doctor to order laboratory testing from RDx Bioscience Inc. (RDx), a clinical laboratory in Kenilworth, New Jersey, and NEXT Bio-Research Services LLC, doing business as NEXT Molecular Analytics (Next Molecular), a clinical laboratory in Chester, Virginia. Carralejo’s company and Ralston allegedly profited from the kickback scheme in the form of commissions from RDx and Next Molecular based on the Houston doctor’s referrals.

From October 2021 to October 2022, Carralejo and his company allegedly conspired with a Texas marketer to pay kickbacks disguised as consulting fees to induce a doctor in Little Rock, Arkansas to order RDx laboratory testing. The settlement resolves allegations that Carralejo provided commission numbers to the Arkansas doctor or her staff so that she could prepare false consulting invoices to disguise both the reason for the Texas marketer’s payments (to induce referrals, not for consulting work) and the calculation of such payments (based on reimbursements from her referrals, not hourly pay for consulting work). Carralejo allegedly tried to hide his role in the fraud scheme by deleting related text messages on the day he and the Texas marketer received subpoenas from the Department of Justice.

Michael Jeresaty of Daniel Island, South Carolina, and his company, Ralston, agreed to pay $320,000 for allegedly paying kickbacks to the Houston physician referenced above and to a South Carolina doctor who previously settled related allegations. The Department of Justice previously settled with RDx allegations relating to Carralejo’s and Jeresaty’s kickback schemes.

The Physician Settlements

The settlements announced today also resolve allegations that four physicians and related entities received kickbacks in violation of the Anti-Kickback Statute from purported management service organizations (MSOs) in return for making referrals to laboratories in Florida and Texas.

• Dr. Paul Bierig agreed to pay $120,634 to resolve allegations that from October 2016 to June 2022, he and his medical practice, Paul C. Bierig, M.D., P.A., received thousands of dollars in payments from Avior Group LLC and other purported MSOs, including Infinity One Health Group MSO LLC and Infinity Three Health Group MSO LLC, in return for ordering laboratory tests from RDx and InHealth Diagnostic LLC doing business as RealLab (InHealth), a clinical laboratory in Dallas, Texas.

• Dr. Mohd Azfar Malik of St. Louis, Missouri, agreed to pay $217,430 to resolve allegations that from January 2019 to March 2020, he and his medical practice, Psych Care Consultants LLC (PCC), received thousands of dollars in payments from a purported MSO, Alari Group LLC (Alari), in return for ordering laboratory tests from Genesis Reference Laboratories LLC (Genesis), a clinical laboratory in Orlando, Florida, and InHealth Diagnostic LLC doing business as RealLab (InHealth), a clinical laboratory in Dallas, Texas. Genesis and InHealth allegedly paid commissions to an independent contractor recruiter, Corum Group LLC (Corum), which used Alari to pay kickbacks to Malik and other healthcare providers in return for their referrals. The Department of Justice previously settled related allegations with Genesis and PCC.

• Dr. Robert Ain of Wichita, Kansas, and his pain management practice, Comprehensive Pain Treatment LLC, agreed to pay $100,632 to resolve allegations that from May 2017 to February 2019, they received thousands of dollars in payments from a purported MSO named Ruthenium Management LLC in return for ordering laboratory tests from Landmark Diagnostics LLC (Landmark), a clinical laboratory in Houston, Texas.

• Dr. Barry Feinberg, Dr. Rachel Feinberg, of St. Louis, and BIF Family Trust, a family trust, agreed to pay $342,466 to resolve allegations that from January 2016 to December 2018, they received thousands of dollars in payments from purported MSOs named ESA Toxicology LLC and Beachwood Services LLC in return for ordering laboratory testing from Landmark.

The parties have agreed to cooperate with the Department of Justice’s investigations of, and litigation against, other participants in the alleged schemes.

The settlements were the result of a coordinated effort between the U.S. Attorney’s Office for the District of New Jersey and the Civil Division’s Commercial Litigation Branch, Fraud Section, with assistance from HHS-OIG.

The government is represented by Assistant U.S. Attorney Kruti Dharia of the U.S. Attorney’s Office, District of New Jersey, Opioid Abuse Prevention and Enforcement Unit and Senior Trial Counsel Christopher Terranova in the Civil Division’s Commercial Litigation Branch (Fraud Section).

The government’s pursuit of these matters illustrates 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 1-800-HHS-TIPS (800-447-8477).

The claims resolved by the settlements are allegations only, and there has been no determination of liability.