Dr. Mark Fleckner, Medicare Fraud, New York 2023

Grimy Times has learned that Dr. Mark Fleckner, a Board Certified Ophthalmologist from Garden City, New York, has agreed to settle civil fraud claims with the United States for $6,955,240.80. The settlement stems from allegations that 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.

The Unapproved Drugs, including aflibercept (“Eylea”) and ranibizumab (“Lucentis”), were 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. 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.

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.”

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.

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