The U.S. Department of Justice recently charged multiple physicians and health care professionals for opioid-related crimes in a crackdown with a clear message to individuals in the industry: If you are involved with prescribing opioids, you should expect enhanced scrutiny. Additionally, an upcoming court case will determine whether medical professionals acting in good faith can still be convicted of criminal conduct. If the government can show that someone unlawfully distributed and/or dispensed controlled substances, or even assisted someone else in doing so, they could face serious time behind bars, regardless of their intentions.

Distributing and Dispensing Controlled Substances

The Controlled Substances Act (CSA) regulates certain drugs that pose a risk of abuse and dependence. The CSA makes it a crime to distribute, dispense and possess with the intent to distribute, certain controlled substances, including opioids, outside the usual course of a professional practice and without a legitimate medical purpose. The government regularly refers to these matters as “pill mill” cases.

The DEA and Strike Forces

The Drug Enforcement Administration (DEA) is the federal agency primarily responsible for implementing and enforcing the CSA. The government has demonstrated its willingness to spend significant resources to combat the distribution of unlawful opioid prescriptions. In 2018, the government created the Appalachian Regional Prescription Opioid (ARPO) Strike Force. The ARPO Strike Force is a joint law enforcement effort that brings together the resources and expertise of the Health Care Fraud Unit in the Criminal Division’s Fraud Section, the U.S. Attorneys’ Offices for numerous federal districts in various states, and law enforcement partners at the FBI, HHS Office of the Inspector General and U.S. Drug Enforcement Administration. The ARPO Strike Force focuses on the Appalachian region and surrounding states. Similarly, the Newark/Philadelphia Medicare Fraud Strike Force focuses on health care fraud and illegal opioid prescriptions in the Newark/Philadelphia region. By creating additional task forces specifically focused on combatting the unlawful distribution of opioids, the government has sent a clear signal to medical professionals that government scrutiny will continue to increase.

Recent Examples of Prosecutions

In the past few months, prosecutions of medical professionals and alleged illegal conduct related to opioids have intensified. Some examples include:

• A Texas physician assistant was convicted of distributing more than 1.2 million opioid pills during his employment at two Houston-area clinics that operated as pill mills. He is scheduled to be sentenced on October 3 and faces up to 20 years in prison for each count on which he is convicted.
• A Tennessee nurse and clinic director were recently charged with unlawfully obtaining opioid pain pills for personal use and further distribution by filling fraudulent prescriptions in the names of current and former hospice patients. According to the indictment, the parties then used the patients’ hospice benefits to cover the costs of the unlawfully obtained prescriptions opioids.
• A Kentucky doctor was charged with unlawfully prescribing opioids to patients whose health care treatments were paid for by taxpayer-funded programs such as Medicare and Medicaid. The doctor allegedly preyed on these patients for continued access to bill these programs for medically unnecessary procedures.

What’s Next for Medical Professionals

This year, the U.S. Supreme Court is expected to decide whether a physician alleged to have prescribed controlled substances outside the usual course of professional practice may be convicted of unlawful distribution under the CSA without regard to whether, in good faith, he “reasonably believed” or “subjectively intended” that the prescriptions fell within that course of professional practice. This would mean that the doctor could still be convicted, even if he reasonably believed he was prescribing opioids for a legitimate medical purpose. The case, Ruan v. United States, was argued before the Supreme Court on March 1, 2022. If the court decides that physicians can be convicted of such criminal conduct, regardless of whether they acted in good faith, medical professionals would be in a very precarious position.

To ensure that physicians are not convicted for merely negligent, rather than intentional conduct, federal courts have permitted doctors to advance a good faith defense. The Supreme Court will soon decide if the physician’s subjective good faith belief that the prescription was being used for a legitimate purpose will stand as a legitimate defense. Otherwise, even if the physician believed he or she was acting properly, the doctor could still be convicted of a federal crime and face time in prison.

Even as we await the decision in Ruan, physicians and health care professionals should expect a continued uptick in investigations related to opioid prescriptions. To avoid ending up as the focus of a criminal investigation, medical professionals should work with counsel to ensure that their conduct cannot not be construed as criminal, even if their intentions are to comply with the law.

A physician otherwise authorized to prescribe opioids can be convicted of unlawful distribution if his or her prescriptions “fall outside the usual course of professional practice.” Facts that the government may use to demonstrate that the physician’s actions fell outside the “usual course of professional practice” include:

• Patients received no warnings before receiving prescriptions for opioids
• Medical records contained errors, such as not listing all prescriptions written or not explaining why a prescription was changed
• Exams and tests listed in medical records did not actually occur
• Rapidly increasing patients’ opioid dosages
• Prescribing opioids to people displaying warning signs for abuse

Additionally, if any government agency approaches medical professionals or employees of a medical practice, counsel should be contacted immediately, before responding to the government official.

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