An ophthalmologist in North Carolina pleaded guilty to using a foreign-made, unapproved drug on patients with macular degeneration, .
James Heroman, MD, 43, formerly of Charlotte, admitted to buying and distributing a cheaper, unapproved medication in place of ranibizumab (Lucentis), the FDA-approved blood vessel growth inhibitor used to treat macular degeneration in the U.S.
The ophthalmologist confessed that he directed his clinic to buy the unapproved drug because it was less expensive than the name brand.
Heroman also falsely billed Medicare for the drug (which was not eligible for reimbursement) as if it were approved by the FDA, the DOJ alleged. He then pocketed the difference in price as a profit, they said.
"Dr. Heroman sought to increase his profit margins by using an unauthorized medication, potentially putting the health of his patients at risk," said William T. Stetzer, the acting U.S. attorney for the Western District of North Carolina, in a statement. "Together with our law enforcement counterparts, we will investigate and prosecute physicians who choose to fill up their pockets at the expense of their patients."
Heroman previously owned an ophthalmology clinic called Carolina Retina and Vitreous Consultants, which has since shut down. He began ordering his clinic to purchase the unapproved drug for macular degeneration patients as early as September 2013.
The ophthalmologist pleaded guilty to receiving and delivering a misbranded medication. In addition to the guilty plea, Heroman and his clinic have agreed to pay $450,000 to resolve allegations by the U.S. government that they violated the False Claims Act, in that they knowingly submitted false reimbursement claims to Medicare linked to the administration of an unauthorized drug. The claims resolved by this civil settlement remain allegations -- there has been no determination of liability.
A sentencing date for Heroman has not yet been decided. The DOJ reported that the charge for receiving and delivering a misbranded medication carries a maximum penalty of 1 year in prison and a $1,000 fine. Heroman's medical license is in North Carolina.
Heroman's lawyer did not respond to a request for comment from MedPage Today.