Supreme Court Sets Criminal Intent Requirement for Prosecution Under Controlled Substances Act

Ruan Background

The Ruan decision consolidated the cases of two physicians, Dr. Xiulu Ruan and Dr. Shakeel Kahn, who issued prescriptions for controlled substances. Both physicians were U.S. Drug Enforcement Administration (DEA)-registered and authorized prescribers, but were separately charged and convicted of violating 21 U.S.C. §841(a)(1) of the CSA, which prohibits any person “except as authorized” to “knowingly or intentionally….distribute or dispense… a controlled substance.” A CSA regulation permits DEA-registered physicians to prescribe controlled substances only if the prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”

At issue in each of the trials was whether the physician possessed the requisite criminal intent (i.e., mens rea) required to support a conviction for unauthorized distribution. The district courts declined to consider the physicians’ subjective intent in issuing the prescriptions, i.e., whether they were issued in good faith or not. Instead, the district courts instructed the jury that a conviction could be supported if the prescriptions fell outside of recognized standards of medical practice. Dr. Ruan and Dr. Kahn were subsequently convicted of prescribing controlled substances in an unauthorized manner and each sentenced to over 20 years in prison. Both convictions were affirmed by the Eleventh and Tenth Circuit Courts of Appeals, respectively.

On appeal, the primary question before the Supreme Court was whether an otherwise authorized prescriber could be found guilty of unlawful distribution of controlled substances if the prescriber believed that the prescription was for a legitimate medical purpose under the CSA—even if, objectively, the prescription fell outside of accepted medical standards. More specifically, the issue turned on whether the “knowingly or intentionally” intent requirement in §841(a) applied to the “except as authorized” clause.

Based on the plain language of the statute and fundamental principles of criminal law, the Supreme Court held that “once a defendant meets the burden of producing evidence that his or her conduct was ‘authorized,’ the government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.” That is, the “knowingly or intentionally” intent requirement under the CSA did apply to the “as authorized” clause under the CSA. Both convictions were remanded to the appellate courts to determine if the jury instructions complied with this heightened standard.

In its reasoning, the court explained the established principle that a “knowingly or intentionally” intent requirement is presumed in criminal contexts, even in statutes that are silent on intent. In fact, such an intent requirement is applied with “equal or greater force” when it is explicitly set forth in the statute. Section 841(a) contains a “knowingly or intentionally” intent requirement, which is necessary because “a lack of authorization [to prescribe] is often what separates wrongfulness from innocence.” Legal authorization “plays a ‘crucial’ role in separating innocent conduct—and, in the case of doctors, socially beneficial conduct—from wrongful conduct.” In general, a heightened criminal intent requirement diminishes the “risk of ‘overdeterrence’” in criminal proceedings.

Lowered burdens of proof proposed by the U.S. Department of Justice (DOJ) and accepted at the trial level (i.e., no heightened intent/mens rea requirement) were bluntly dismissed by the court. The court noted its reluctance to apply a negligence standard in criminal cases. An objective reasonableness standard “would turn a defendant’s criminal liability on the mental state of a hypothetical ‘reasonable’ doctor, not on the mental state of the defendant himself.” The court reiterated, with few exceptions, “wrongdoing must be conscious to the criminal.” Otherwise put, an authorized prescriber acting in good faith should not be criminalized under the CSA for writing a prescription they believe to be necessary but may not comport with recognized standards of medical practice. Such a prescriber lacks the requisite intent to actually violate the CSA and face years in prison.

Notably, Ruan resolves a circuit split as to the level of criminal intent required to secure prescriber convictions under the CSA. Prior to Ruan, practitioners were held to different standards depending on the jurisdiction in which they practiced medicine. The Ruan decision should work to correct this inherent unfairness by ensuring that a prescriber’s intent is always a required element for CSA convictions. Moving forward, authorized prescribers in every jurisdiction will now be able to assert a “good faith” defense if they are criminally charged with prescribing controlled substances in an unauthorized manner.

America’s Opioid Crisis: A New Approach

The Ruan decision came amidst the nation’s worst opioid epidemic. The United States continues to face record-breaking numbers of annual overdose deaths, even though the American Medical Association’s (AMA) 2022 Overdose Epidemic Report shows that opioid prescriptions have decreased consecutively for ten years in a row, with a 46.4 percent decrease in opioid prescriptions since 2012. Collective efforts from physicians and other healthcare providers to combat the nation’s opioid crisis also led to a significant increase in the use of state prescription drug monitoring programs (PDMPs), with nearly 4 billion queries since 2014. Despite these efforts, drug-related overdose deaths continue to rise. The numbers make one thing clear: Reductions in opioid prescribing have not led to reductions in drug-related deaths.

The reason that measurable progress by healthcare professionals has not corrected the problem is simple—America’s opioid crisis has evolved, but the solutions have not. The country’s opioid epidemic has shifted rapidly from prescription opioids in the mid-1990s to heroin, illicitly manufactured fentanyl, methamphetamine, and other illicit substances. Still, government agencies continue to heavily scrutinize the practices of lawful prescribers and suppliers of opioids. Such efforts fail to adequately address the current opioid epidemic and, in some cases, have devastated effective care treatments for legitimate patients.

The Ruan decision is indicative of a recent shift from the blanket vilification of opioid use in favor of improving access to evidence-based care and harm-reduction methods. Medical advocacy groups have taken note of a need to change course. By way of example, the AMA partnered with the American Academy of Family Physicians (AAFP) in 2021 by uniting two task forces to create the AMA Substance Use and Pain Care Task Force. The Task Force was formed to study the current state of the epidemic and develop recommendations to address the epidemic’s driving factors. The Task Force, joined by dozens of state, national, and other specialty medical organizations, has released recommendations to improve outcomes and reduce mortality. Among other things, the actions recommended include:

• Decriminalization of drug-checking supplies, such as life-saving fentanyl test strips
• Urging states to adopt federal telehealth flexibilities to allow certain anti-overdose drugs to be induced at home
• Removing the prescription status of anti-overdose drug naloxone to make it available over the counter
• Holding insurers accountable for repeated, intentional violations of state and federal mental health and SUD parity laws

The Centers for Disease Control and Prevention (CDC) recently followed suit. In February 2022, the CDC updated its crisis-driven 2016 opioid prescribing guidelines to support an individualized approach to prescribing. The original 2016 guidelines contained rigid limitations on the number of allowable days and dosages for opioid prescriptions. These limitations led to negative patient outcomes due to ineffective pain management, the sudden discontinuation of long-term opioids, and/or the discontinuation of prescribing opioids altogether. Further, studies showed that reduced access to prescription opioids led to an increase in illicit drug use. Evidence of the ineffectiveness of the 2016 guidelines and the continued rise in the annual overdose rate drove the CDC to reconsider and update its opioid prescribing guidelines by removing arbitrary limitations and supporting a patient-centered approach to prescribing.

While the Ruan decision, CDC prescribing guidance, and AMA/AAFP Task Force recommended actions indicate a change in course related to the treatment of lawful opioid prescriptions, prescribers should continue to take precautions and implement safeguards. State and federal agencies will likely continue to scrutinize prescriber habits and be on the lookout for what they consider to be “red flag” behaviors. The DOJ takes the staunch stance that healthcare providers have a duty to detect suspicious activity when making decisions about prescribing controlled substances. Common “red flags” cited in enforcement actions that may invite attention include:

• Patients did not receive proper education or warnings before receiving opioid prescriptions
• Medical documentation and records were incomplete or otherwise contained errors
• Patient tests and examinations were listed in medical records, but did not occur
• Patient failed drug screenings
• Patient opioid dosages increased rapidly
• Patients received opioid prescriptions despite displaying warning signs for abuse or substance addiction

These behaviors often have innocent explanations, and Ruan protects well-intentioned providers by requiring a showing of criminal intent to support CSA convictions—even where “red flag” behaviors are present. Still, prescribers should take care to stay updated on both state and federal laws and regulations pertaining to opioid prescribing, review enforcement actions for insight on “red flag” behaviors, read professional society guidance documents, and review the CDC’s 2022 Opioid Prescribing Guidelines for best prescribing practices. It is essential to maintain thorough, precise documentation for all patients prescribed opioids; records should establish a detailed basis for each prescription and decision related to the patient’s opioid use.

By implementing safeguards into practice, prescribers will demonstrate a clear intention to comply with the law and minimize risk of enforcement action.

Implications of the Ruan Ruling

The Ruan ruling is noteworthy for numerous reasons. Significantly, Ruan affirms the core principle that criminal law is intended to punish conscious wrongdoing. This is particularly important in the context of opioid prescribing—a practice heavily scrutinized at all levels of government, and generally disfavored in the court of public opinion. The Ruan decision should not only ensure criminal laws are enforced fairly (i.e., against those with the requisite intent to commit a crime), but also limit the discretion of prosecutors and government influence over the practice of medicine. Moving forward, prescribers acting in good faith, prescribing opioids in an appropriate manner, will have a key precedent to cite should they find themselves subject to a government investigation.

Stakeholders should monitor how lower courts apply the Ruan decision. Ruan is directly applicable to opioid prescribers but also applies to suppliers and pharmaceutical companies authorized to dispense or manufacture controlled substances under the same CSA provision. Governmental enforcement actions under other major criminal healthcare statutes may also be impacted by the decision. Several criminal healthcare laws, such as the Anti-Kickback Statute (AKS), and criminal provisions of the False Claims Act (FCA) contain the same intent standard as the CSA. The ruling may also affect the civil enforcement of healthcare laws, particularly where criminal statutes are enforced through civil means.

It is important to note that given the government’s vigorous efforts to address the opioid crisis, scrutiny into prescribing and dispensing practices is unlikely to stall. The DOJ and DEA will continue to use their systems of red flags to launch investigations into opioid prescribers and suppliers. However, the increased burden of proof created by Ruan will require agencies to focus resources on more blatant and/or egregious cases—alleviating stresses of good faith physicians and patients alike.

Conclusion

The Ruan decision sets an important protection for providers, and limitation on prosecutions, as it creates a distinction between good faith medical errors and/or decisions and criminal behavior. Healthcare professionals and other stakeholders should continue to monitor how the legal landscape develops as we experience a paradigm shift in addressing the current opioid epidemic—and continue education on best practice for opioid prescribing as the nation’s response evolves.