A federal district court in Ohio has entered a consent judgment and permanent injunction barring Dr. Gregory Gerber from prescribing controlled substances and ordering him to pay more than $4.76 million to resolve allegations that he had issued illicit prescriptions in violation of the Controlled Substances Act (CSA) (United States v. Gerber, No. 3:21-cr-00260-JRK (N.D. Ohio)).

In an August 2018 complaint filed in the U.S. District Court for the Northern District of Ohio, the Department of Justice (DOJ) alleged that between July 2012 and June 2018 Gerber “issued over 4,800 prescriptions for powerful opioids and other controlled substances highly prone to abuse.”

“Ignoring his oath to do no harm,” the government had told the court, “Dr. Gerber instead fed his patients’ addiction and caused thousands of pills of opioids and other controlled substances to be illegally dispensed.”

The DOJ had alleged that Gerber violated the CSA by issuing prescriptions that had no legitimate medical purpose and that fell outside the usual course of professional medical practice.

One patient died from an overdose of fentanyl patches prescribed by Gerber, the government alleged. Fentanyl had not been indicated by the patient’s diagnoses, it said.

Alleged Kickbacks

It also had alleged that the physician violated the False Claims Act (FCA) by accepting kickbacks from Insys Therapeutics Inc. in the form of speaker fees to promote Subsys, a form of fentanyl — an opioid that is 30 to 50 times more potent than heroin and 50 to 100 times more potent than morphine, the government noted.

Subsys is approved by the FDA only for the treatment of breakthrough pain experienced by adult cancer patients who had found other opioids to be insufficient to treat breakthrough pain.

Insys allegedly paid Gerber more than $175,000 between 2013 and 2016, including more than $140,000 ostensibly as honoraria and compensation for speaker services to promote Subsys. “In fact,” the DOJ said, “the speaker program was simply a pretext for paying Dr. Gerber for the purpose of inducing him to prescribe Subsys.”

Other Alleged FCA Violations

Gerber also violated the FCA, the DOJ said, by issuing prescriptions that had no legitimate medical purpose and fell outside the usual course of professional medical practice and by prescribing Subsys and the cannabinoid Marinol (and its generic equivalent, dronabinol) without a medically accepted indication.

The prescriptions violated the FCA, the government alleged, because Gerber caused pharmacies to submit false or fraudulent reimbursement claims to Medicare Part D plan sponsors, because:

• the prescriptions were not covered by Part D because they were not for medically accepted indications;
• the controlled substances were dispensed without a valid prescription under Ohio law since they were not issued for a legitimate medical purpose by Gerber acting in the usual course of professional practice and therefore were not covered by Part D; and
• the claims for Subsys were submitted in violation of the Anti-Kickback Statute and therefore not payable by Part D.

Terms of Consent Judgment

The consent judgment permanently prohibited Gerber from prescribing opioids or other controlled substances. It also barred him from holding, applying for or seeking renewal of a DEA certificate of registration, managing or owning any legal entity that administers or dispenses controlled substances, working for any entity that administers or dispenses controlled substances (with the exception of a company with more than 50 employees), and owning, managing or having an equity interest in any property where controlled substances are dispensed or distributed.

Also under the consent judgment, Gerber was ordered to pay the United States $4,761,326.62 plus interest under the FCA.

In August 2018, the district court had issued a temporary restraining order (TRO) and preliminary injunction prohibiting Gerber from prescribing any controlled substances. The TROs issued at that time against Gerber and against another Ohio doctor were the first such legal action taken by the DOJ against physicians who were allegedly prescribing opioids illegally.

The DOJ noted that the claims it made in the complaint were allegations that the government would have had to prove by a preponderance of the evidence if the case had gone to trial.

September 2023 Guilty Plea

The civil resolution follows Gerber’s September 2023 guilty plea to charges of illegally distributing controlled substances in violation of the CSA (United States v. Gerber, No. 3:21-cr-00260-JRK (N.D. Ohio)).

On March 12 he was sentenced to serve 42 months in prison followed by three years of supervised release. He was also ordered to pay $861.892.13 in restitution.

Gerber had been accused in an April 2021 indictment of 51 counts of illegally distributing controlled substances and two counts of health care fraud.

The health care fraud counts were based in part on allegations that Gerber:

• performed inadequate patient physical and historical examinations;
• failed to establish evidence-based, objective diagnoses for patients’ pain;
• failed to establish the presence of patients’ intractable pain and the signs, symptoms and causes of the underlying pain mechanisms;
• failed to formulate individualized treatment plans in patient medical records;
• used false diagnoses to prescribe controlled substances;
• prescribed controlled substance without adequately investigating pain complaints, including failing to perform and order appropriate diagnostic tests;
• prescribed controlled substances without considering other treatment modalities;
• increased the dosage of controlled substances, and prescribed controlled substances for prolonged time periods, without evidence of efficacy;
• prescribed excessive doses of controlled substances;
• failed to consult with medical specialists in treating patients;
• ignored signs of patient addiction and drug abuse, and failed to consult with addiction medicine specialists and other substance abuse professionals, to obtain a formal assessment of addiction and drug abuse;
• prescribed opioids and benzodiazepines concurrently without a significant, valid medical diagnosis;
• wrote medically unnecessary prescriptions of Subsys in return for the payment of honoraria and expenses from Insys;
• conducted speaker’s bureau programs for Insys that purported to provide substantive medical information about Subsys to physicians and other health care providers but that in fact contained little to no educational value and were presented to people who could not prescribe controlled substances;
• wrote Subsys prescriptions in return for the payment of honoraria, expenses and other things of value from Insys;
• submitted and cause the submission of billings to Medicare, Medicaid and private insurers for Subsys prescriptions for patients who did not have breakthrough cancer pain; and
• submitted and caused the submission of billings to Medicare, Medicaid and private insurers for medically unnecessary controlled substance prescriptions.

The government also alleged that Gerber failed to adequately document and maintain patient medical files and that he had caused the submission of billings to Medicare, Medicaid and private insurers for patient evaluation and management services using inflated or upcoded Current Procedural Terminology (CPT) codes that reflected services that were more costly than the services that he actually performed.

Gerber pleaded guilty only to the 51 counts of alleged CSA violations. He did not plead guilty to the two health care fraud counts.