Dr. James W. Heroman, 43, formerly of Charlotte, appeared before US Magistrate Judge David S. Cayer on Monday, October 4, 2021, and pleaded guilty to receiving and delivering a misbranded medication. Dr. Heroman is an ophthalmologist and the former owner of a now-closed ophthalmology clinic, Carolina Retina and Vitreous Consultants (CRVC). According to plea documents filed with the court, as early as September 2013, Dr. Heroman caused CRVC to order and receive an unapproved, foreign, and cheaper drug which he used to treat patients with macular degeneration, instead of using Lucentis®, the medication approved by the Food and Drug Administration (FDA) for the treatment of the condition in the United States.
As Dr. Heroman admitted in court, he purchased the foreign, unapproved medication because it cost less than the name brand Lucentis®. At the same time, Dr. Heroman caused CRVC to bill Medicare for the non-covered and non-reimbursable unapproved medication as if it were FDA-approved and kept the difference in price as profit. In addition to pleading guilty to the criminal charge, Dr. Heroman and CRVC have also agreed to pay $450,000 to resolve the United States’ allegations that they violated the False Claims Act, when they knowingly submitted or caused to be submitted false claims for payment to Medicare related to the administration of unapproved medications. The claims resolved by the civil settlement are allegations only and there has been no determination of liability.
