On the heels of the U.S. Supreme Court's June decision in Ruan v. U.S., which held that to demonstrate the necessary criminal intent, the government must prove beyond a reasonable doubt that a medical provider knowingly or intentionally acted in an unauthorized manner when prescribing opioids, the U.S. Department of Justice created a new strike force in New England to focus on illegal opioid prescriptions.

The DOJ's decision to create this task force, especially after the Ruan decision, signals that the government intends to intensify investigations into medical professionals prescribing opioids.

The New Opioid Strike Force

DOJ Criminal Division Assistant Attorney General Kenneth Polite announced the formation of the New England Prescription Opioid, or NEPO, Strike Force in late June.

He explained that the strike force will entail a joint law enforcement effort using resources from the Health Care Fraud Unit in the Criminal Division's Fraud Section, U.S. attorneys' offices for three federal districts, law enforcement partners at the U.S. Department of Health and Human Services Office of the Inspector General, U.S. Drug Enforcement Administration and the FBI.

Its mission is to investigate the alleged illegal distribution of prescription opioids and to target alleged criminal conduct by all medical professionals.

Nikolas Kerest, U.S. attorney for the District of Vermont, stated that the NEPO Strike Force

demonstrates the Department of Justice's commitment to working with our law enforcement partners in Vermont and elsewhere to hold accountable health care providers who exploit the opioid epidemic for personal gain … Health care providers who issue illegal opioid prescriptions undermine important efforts to address the epidemic while putting patients at risk of overdose and physical harm.

Xiulu Ruan v. U.S.

The DOJ's announcement of the NEPO Strike Force just days after the Supreme Court's decision in Xiulu Ruan v. U.S. demonstrates the government's unwavering dedication to combating illegal opioid prescriptions.

In Ruan, the court overturned two physicians' convictions for prescribing opioids outside the usual course of medical treatment.

The court held that the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner, meaning that it would be relevant whether the medical professional acted in good faith.

Thus, if a medical professional reasonably believed they were prescribing opioids for a legitimate medical purpose, they did not knowingly or intentionally act in an unauthorized manner.

What Medical Professionals Can Expect

Despite the favorable ruling in Ruan, physicians and health care professionals should expect enhanced scrutiny and a continued increase in investigations.

While Ruan may have made it more difficult for the government to prove that a medical professional acted in an unauthorized manner, the creation of the NEPO Strike Force and similar government strike forces, such as the Appalachian Regional Prescription Opioid Strike Force and Newark/Philadelphia Medicare Fraud Strike Force,[1] will continue to lead to more investigations.

The NEPO Strike Force promises to target conduct by physicians, pharmacists and any other medical professional. Because the government is committed to combating the opioid crisis, medical professionals can expect that federal agencies will use considerable resources in their investigations.

Many investigations originate with a tip. Current employees, former employees, patients, patients' family members or any concerned or disgruntled person can contact the DOJ's Health Care Fraud Unit and report what they believe to be illegal opioid prescribing.

The government makes reporting suspected health care fraud easy by providing not only a mailing address, but numerous email addresses[2] and tip line phone numbers.[3]

Once a tip is reported, the government will begin an investigation, which can entail reviewing medical records and talking to medical practice personnel or prior patients.

Undercover agents may disguise themselves as patients to learn about a particular medical practice or a physician's process for prescribing opioids.

Tips and Best Practices

To prevent their clients from ending up as the target of a criminal investigation involving opioids, medical professionals' attorneys should ensure that their practices and documentation support a conclusion of appropriate prescribing and do not raise suspicion of potential criminal conduct.

Facts that the government may use to prove that the physician's actions were criminal and thus 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;
• Rapid increases in patients' opioid dosages; and
• Opioids prescribed to people displaying warning signs for abuse.

Detailed record-keeping is key. Medical professionals' attorneys should conduct an objective review to:

• Strengthen their clients' policies and procedures and determine facts that warrant further clinician scrutiny and evaluation of patient prescription requests;
• Identify warning signs of patient illicit drug seeking behavior;
• Provide for assessment of prescription changes; and
• Ensure thorough patient exams and tests, and monitoring of patient response and conduct, with associated documentation consistent with appropriate diagnosis, treatment and prescribing that will help the clinician avoid investigation or quickly persuade law enforcement that the clinician acted reasonably based upon known information and circumstances.

Health care professionals' attorneys should be proactive and should ensure that medical professionals and employees of a medical practice are trained to contact them before responding to any inquiry from a government official.

[1] For example, the Appalachian Regional Prescription Opioid (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.

[2] The mailing address and e-mail addresses and mailing address are available: https://www.justice.gov/criminal-fraud/health-care-fraud-unit.

[3] The tip line phone numbers are available: https://www.justice.gov/criminal-fraud/report-fraud.

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