A Garden City ophthalmologist will pay nearly $7 million to settle civil fraud claims that he used unapproved drugs purchased overseas on patients and then sought reimbursement by Medicare, federal prosecutors announced Monday.
The agreement calls for Dr. Mark Fleckner, who has offices on Franklin Avenue in Garden City and in Fresh Meadows, Queens, to pay $6.95 million to settle federal False Claims Act violations, according to Richard Donoghue, U.S. attorney for the Eastern District of New York.
“Dr. Fleckner bypassed the FDA’s regulatory authority by purchasing and administering unapproved pharmaceutical products in violation of Medicare regulations,” Donoghue said. “The settlement holds Dr. Fleckner accountable for his actions and ensures that Medicare funds will only be used for FDA-approved pharmaceuticals.”
Alexander Bateman, Fleckner's Uniondale-based attorney, said his client "inadvertently" distributed drugs that were not approved by the Food and Drug Administration.
"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 government’s investigation found that from July 2014 though June 2017, Fleckner purchased Eylea and Lucentis, which are used to treat patients who had age-related macular degeneration. The drugs, which are less expensive than similar drugs approved by the FDA, had not been evaluated for use in the United States and were not eligible for Medicare reimbursement, prosecutors said.
Medicare reimburses physician-administered pharmaceuticals at a predetermined rate based on the average sales price of FDA-approved drugs. Fleckner, prosecutors said, was able to profit from the difference between the reimbursement rates he received and the lower cost he paid for the unapproved drugs.
“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.”