News Briefs: October 1, 2018

◆ Ophthalmologist Mark Fleckner, M.D., who practices in Garden City, New York, agreed to pay $6.9 million to settle false claims allegations that he administered certain drugs that he bought overseas and that hadn’t been evaluated or approved by the Food and Drug Administration, the U.S. Attorney’s Office for the Eastern District of New York said September 24. They include aflibercept (Eylea) and ranibizumab (Lucentis), which Fleckner used to treat patients with wet, age-related macular degeneration or other eye diseases and conditions. “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,” the U.S. attorney’s office said. Medicare pays physician-administered drugs based on the average sales price of the FDA approved, physician-administered drug in the United States. As a result, Fleckner allegedly profited from the spread between the reimbursement rates he got based on FDA-approved drugs and the lower amounts he shelled out for the unapproved drugs. DOJ contends the unapproved drugs don’t qualify for Medicare reimbursement. Fleckner didn’t admit wrongdoing in the settlement. Visit

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