Stephen Ziegler, PhD, JD: Implications of the Ruan v United States Decision in Prescribing Opioids

As a part of our Congress of Clinical Rheumatology West coverage, Stephen Ziegler, PhD, JD, discusses his presentation, “Pain Management, Prescribing, and Prosecution: The U.S. Supreme Court Decision in Ruan v United States (2022).” Ziegler is professor emeritus from Purdue University in Fort Wayne, Indiana.

The ruling of Ruan v United States, decided in 2022, had significant implications for healthcare prescribers.

“I served as the lead author and filed an amicus brief before the United States Supreme Court,” Ziegler explained. “The primary issue in this case revolved around whether the government needed to prove that the prescriber had knowledge that the prescription they were writing was not authorized by law.”

Prior to this ruling, the government's stance was they only needed to demonstrate that the prescription itself fell outside the standard of care. Ziegler noted if the prescription violated the Controlled Substances Act (CSA), the prescriber could be subject to penalties. Ultimately, the government believed the prescriber's intent to prescribe was the critical factor, rather than whether they knew it breached the standard of care.

However, the United States Supreme Court ruled knowledge was a requirement under the statute. The government now had to prove beyond a reasonable doubt the prescriber knew it was not authorized by the CSA.

“My advice for prescribers would be to continue documenting in the patient's chart the reasons behind their decisions and prescriptions,” Ziegler stated. “Prescribers are still facing challenges, and some are even hesitant to prescribe for pain management, which ultimately harms their patients. While it's a step in the right direction, the situation is not entirely resolved."

Regarding compliance with state rules, he encourages prescribers to adhere to their state's regulations.

“Prescribers must comply with the prescribing guidelines set forth by the Drug Enforcement Administration (DEA),” Ziegler emphasized. “They should prioritize thorough documentation in their medical charts to explain their decision-making processes, as inadequate documentation often leads to problems."

This transcript was edited for clarity.