The United States has entered into an agreement to settle civil fraud claims with Dr. Mark Fleckner, a Board Certified Ophthalmologist who maintains a practice in Garden City, New York. The agreement resolves allegations that, in contravention of Medicare regulations and in violation of the federal False Claims Act, Dr. Fleckner administered certain pharmaceutical products that he had purchased overseas, which the U.S. Food and Drug Administration (“FDA”) had not evaluated nor approved for use in the United States (“Unapproved Drugs”). These products included aflibercept (“Eylea”) and ranibizumab (“Lucentis”), which Dr. Fleckner used to treat patients who had wet, age-related macular degeneration or other diseases and conditions of the eye. The United States contends that the Unapproved Drugs were not eligible for reimbursement by Medicare. Under the terms of the civil settlement agreement, Dr. Fleckner will pay a total of $6,955,240.80.
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.
“Dr. Fleckner bypassed the FDA’s regulatory authority by purchasing and administering unapproved pharmaceutical products in violation of Medicare regulations,” stated United States Attorney Donoghue. “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.”
“FDA approval provides confidence to millions of patients that drugs are safe when prescribed appropriately,” stated HHS-OIG Special Agent-in-Charge Lampert. “Those administering unapproved medications – as contended in this case – put patients at risk and burden taxpayers.”
The government’s investigation revealed that from at least July 1, 2014 to June 27, 2017, Dr. Fleckner purchased the Unapproved Drugs because they were less expensive than drugs that were approved by the FDA for marketing in the United States. Medicare reimburses physician-administered drugs at a set rate based on the average sales price of the respective FDA approved, physician-administered drug in the United States. Dr. Fleckner was thus able to profit from the “spread” between the reimbursement rates he received based on FDA-approved drugs and the lower amounts he paid for the Unapproved Drugs. The United States contends that the Unapproved Drugs were not eligible for reimbursement by Medicare. The settlement is not an admission of wrongdoing by Dr. Fleckner.
The United States’ investigation was handled by former Assistant U.S. Attorney Kenneth M. Abell of the Office’s Civil Division.
DR. MARK FLECKNER
Garden City, New York