Doctor Reaches Settlement for Administering Unapproved Drugs, Seeking Medicare Reimbursement
Dr. Mark Fleckner, a Garden City, New York, ophthalmologist, will pay close to $7 million to settle civil fraud claims that allege he used unapproved drugs purchased overseas, which were not approved by the Food and Drug Administration (FDA), on his patients, then sought reimbursement by Medicare. Fleckner, who has offices on Franklin Avenue in Garden City and in Fresh Meadows, Queens, will pay $6.95 million to settle federal False Claims Act violations. The settlement is not an admission of wrongdoing.
“Dr. Fleckner bypassed the FDA’s regulatory authority by purchasing and administering unapproved pharmaceutical products in violation of Medicare regulations,” said Richard P. Donoghue, United States Attorney for the Eastern District of New York. “The settlement holds Dr. Fleckner accountable for his actions and ensures that Medicare funds will only be used for FDA-approved pharmaceuticals.”
“FDA’s oversight of prescription drugs protects consumers from illicit medicines obtained from unauthorized foreign sources,” stated FDA-OCI Special Agent-in-Charge Ebersole. “We will continue to pursue and bring to justice those who place profits over their patients’ safety.”
Alexander Bateman, the doctor’s attorney, said his client “inadvertently” distributed drugs that were not approved by the Food and Drug Administration, and in no way was focused on optimizing profit over patient safety.
“No patients were harmed in the administration of these drugs, which had the same efficacy of FDA-approved drugs,” Bateman said. “Dr. Fleckner has put in processes in his office to make sure this does not happen again.”
The federal investigation discovered that in the three-year period from July 2014 through June 2017, Fleckner purchased Eylea and Lucentis, used to treat patients with age-related macular degeneration. The drugs are less expensive than those approved for use by the FDA and had not been evaluated for use in the United States. Thus, it was illegal to administer them to patients and seek compensation for doing so. The drugs were not eligible for Medicare reimbursement.
Medicare reimburses physician-administered pharmaceuticals at a predetermined rate based on the average sales price of FDA-approved drugs. According to federal prosecutors, Fleckner was able to profit from the difference between the reimbursement rates he received and the lower cost he paid. It was in his best interest to purchase and use drugs that would less expensive in order to reap the benefit of a higher profit margin.
“FDA approval provides confidence to millions of patients that drugs are safe when prescribed appropriately,” said Scott Lampert, FBI special agent-in-charge of the Department of Health and Human Services. “Those administering unapproved medications, as contended in this case, put patients at risk and burden taxpayers.”
The United States’ investigation was taken up by former Assistant U.S. Attorney Kenneth M. Abell of the Office’s Civil Division. Richard P. Donoghue, United States Attorney for the Eastern District of New York; Jeffrey J. Ebersole, Special Agent-in-Charge, Food and Drug Administration, Office of Criminal Investigations (FDA-OCI), New York Field Office; and Scott J. Lampert, Special Agent-in-Charge, U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG), New York Region, announced the settlement.