In a win for health care providers and patients, the Supreme Court unanimously ruled against the government in Ruan v. United States, clarifying the burden of proof for prosecutions of healthcare providers for unlawful distribution of controlled substances under the Controlled Substances Act (CSA).

Section 841 of the CSA makes it a crime “except as authorized…for any person, knowingly or intentionally, … to manufacture, distribute, or dispense … a controlled substance.” The government argued for a mere negligence standard, but the Supreme Court disagreed, holding that the government must prove beyond a reasonable doubt that a provider knowingly or intentionally acted in an unauthorized manner.

The Supreme Court has shown that a provider’s state of mind and intentions, not the DEA’s interpretation of their practice of medicine, will determine whether a prescription was unauthorized and warrants conviction. An unauthorized prescription is one not issued for a legitimate medical purpose or written outside the course of the prescriber’s usual course of professional practice.

This Supreme Court consolidated two cases, United States v. Kahn and Ruan v. United States, on appeal from the Tenth and Eleventh Circuits, respectively. Both circuit courts had sided with the government, upholding their respective district courts’ rulings, and finding two physicians guilty of improperly prescribing opioids. The Supreme Court remanded the cases to the lower courts for review under the clarified standard for criminal intent.

This case is a significant win for health care providers concerned about the overcriminalization of medical decision making associated with treating patients with substance use disorders, pain, anxiety, ADHD, insomnia, and other conditions that may require controlled medications. The government must now prove that a provider knew or intended to prescribe controlled substances for an illegitimate medical purpose or outside the usual course of his or her professional practice to obtain a conviction under the CSA.

Read CUSP’s amicus brief here.

Read CUSP’s full statement in response to the Supreme Court decision here.

Read the full opinion here.