CHARLOTTE, North Carolina – Dr. James W. Heroman, 43, formerly of Charlotte, appeared before U.S. Magistrate Judge David S. Cayer on Monday, October 4, 2021 and pleaded guilty to receiving and delivering medication mislabeled, said William T. Stetzer, acting US attorney for the Western District of North Carolina.
Derrick L. Jackson, Special Agent in Charge, United States Department of Health and Human Services, Office of the Inspector General for the Region, including North Carolina, and Judge C. Fielder, Special Agent in Charge of Food and Drug Administration, Bureau of Criminal Investigations (FDA-OCI), Miami Field Office join Acting U.S. Attorney Stetzer in making today’s announcement.
Dr Heroman is an ophthalmologist and former owner of a now closed ophthalmology clinic, Carolina Retina and Vitreous Consultants (CRVC). According to advocacy documents filed with the court, as early as September 2013, Dr. Heroman had CRVC order and receive an unapproved, foreign, and cheaper drug that he was using to treat patients with macular degeneration, instead to use Lucentis®, the approved medicine. by the Food and Drug Administration (FDA) for the treatment of the disease in the United States. As Dr Heroman admitted in court yesterday, he bought the unapproved foreign drug because it was cheaper than the brand name Lucentis®. At the same time, Dr Heroman made CRVC bill Medicare for unapproved uncovered and non-reimbursable drugs as if they were FDA approved and kept the price difference as profit.
In addition to pleading guilty to the criminal charge, Dr Heroman and CRVC also agreed to pay $ 450,000 to resolve US allegations that they violated the False Claims Act, when they knowingly submitted or made submitting false claims to Medicare related to the administration of unapproved drugs. The claims resolved by the Civil Settlement are only allegations and there has been no determination of liability.
Making today’s announcement, Acting US Attorney Stetzer said, “Dr. Heroman has sought to increase his profit margins by using an unauthorized drug, potentially putting the health of his patients at risk. Together with our law enforcement counterparts, we will investigate and prosecute physicians who choose to line their pockets at the expense of their patients. “
“Doctors who provide drugs not approved by the FDA to their patients put those in their care unnecessarily,” said Special Agent in Charge Jackson. “Together with our law enforcement partners, our watchdog will investigate these fraud schemes that threaten the health of patients and the integrity of federal health care programs. “
“American patients rely on FDA oversight to make sure the drugs and medical devices they use are safe and effective. Dishonest medical professionals who procure unapproved foreign medical products, and distribute and administer these products to their patients, are putting the health of those patients at risk, ”said Special Agent in Charge Fielder. “We will continue to prosecute and bring to justice those who choose to endanger public health. “
A sentencing date for Dr Heroman has not been set. The charge of receiving and delivering a mislabelled drug carries a maximum sentence of one year in prison and a fine of $ 1,000.
In making today’s announcement, Acting US Attorney Stetzer commended the HHS-OIG and FDA-OCI for their investigation into the case.
Assistant US Attorney Michael Savage is continuing the criminal case. US Assistant Prosecutor Katherine Armstrong is in charge of civil proceedings.