A recent U.S. Supreme Court decision in the case of Ruan v. United States clarified the “intent element” in prosecutions of physicians for violations of the federal Controlled Substances Act (“CSA”) that are based on allegations of excessive prescribing of controlled substances, namely opioids. The Ruan opinion should also be of benefit to pharmacists subject to like prosecutions.
The potential for the prosecution of pharmacists for violations of the CSA has increased exponentially since the pharmacist’s benchmark in dispensing controlled substances evolved from the “clerical accuracy standard” to the “corresponding responsibility standard” of today. Under federal law, specifically 21 U.S.C. § 1306.04(a),
A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.
The U.S. Drug Enforcement Administration (“DEA”) and some courts have interpreted the “corresponding responsibility” of a pharmacist as due diligence, even vigilance, to be exercised in preventing the dispensing of prescriptions issued for nonmedical purposes. That means recognizing and resolving “red flags” before filling controlled substance prescriptions. When a pharmacist acts outside of his or her “corresponding responsibility” of dispensing controlled substances for a legitimate purpose, criminal prosecution may ensue.
Although neither the DEA nor the U.S. Department of Justice (“DOJ”) has issued an exhaustive list of red flags that pharmacies must be aware of, in an order issued by DEA in December 2021, the DEA stated that red flags “are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm.” 86 Fed. Reg. 72694, 72703 (Dec. 22, 2021). The December 2021 Order provides a detailed overview of some of the most common red flags, which include cocktail medications, improper dosing for pain management, patients traveling long distances, cash payments, and price gauging. For example, the DEA considers cocktail medications that combine controlled substances, such as opioids with orders for other central nervous system depressants or muscle relaxants, to not only significantly increase a patient’s risk of death or overdose, but also to be highly subject to abuse and/or diversion. Likewise, large doses of short-acting opioids (as opposed to short-acting opioids on an “as needed” basis for breakthrough pain), patients traveling an inordinate distance to fill prescriptions for controlled substances (routine travel of 40 miles or more), and patients who routinely opt to pay in cash when there is insurance coverage, are considered “red flags” by the DEA that should be identified and addressed by pharmacists. Finally, the DEA has made it clear that a significant red flag – and evidence of a pharmacist’s intent to ignore the red flag – occurs when a patient pays for opioids or other controlled substances for which the pharmacy has charged higher than market value.
The Supreme Court’s decision in Ruan, although pertaining to the convictions of two doctors for unlawful distribution (prescribing) of opioids, should be illustrative in future investigations and prosecutions involving pharmacists. The doctors in Ruan argued that even if the prescriptions were unauthorized (not written in compliance with CSA), they were acting in “good faith” in prescribing medications to patients for medically necessary reasons. As framed in the majority opinion authored by Justice Stephen Breyer, the issue before the Court was whether, in proving that a doctor’s dispensation of drugs via prescription falls within the CSA’s prohibition, it is “sufficient for the Government to prove that a prescription was in fact not authorized, or must the Government prove that the doctor knew or intended that the prescription was unauthorized?” DOJ’s position has historically been that the CSA’s prohibition merely requires it to prove knowing or intentional distribution or prescribing. The Court disagreed, holding that prosecutors must prove beyond a reasonable doubt, after the defendant produces evidence that (s)he was authorized to prescribe controlled substances in relation to his/her professional role, that the defendant prescriber knowingly or intentionally acted in an unauthorized manner.
Justice Breyer cited several reasons for concluding that proof of intentional wrongdoing is required, including the severity of the CSA’s penalties, which in some cases can include life imprisonment and fines up to $1 million. The majority opinion was joined by Chief Justine John Roberts and Justices Sonia Sotomayor, Elena Kagan, Neil Gorsuch and Brett Kavanaugh. Justice Samuel Alito filed a concurring opinion that was joined fully by Justice Clarence Thomas and partly by Justice Amy Coney Barrett.
The Court’s decision is celebrated by advocates for pain patients and health policy experts who have voiced concern that aggressive prosecution in this area will deter practitioners from prescribing legitimate painkillers to patients in need. It should also be of benefit to pharmacists who are dispensing pursuant to those prescriptions. Nonetheless, the enforcement environment around controlled substances remains intense and the “red flag” theory of liability remains problematic, making it all the more important that industry participants be guided by competent counsel in response to regulatory inquiries or government investigations.
How Frier Levitt Can Help
Frier Levitt has a long history of defending pharmacies and prescribers in criminal, civil and administrative actions relating to opioids and controlled substances, as well as counseling them on proper practices under federal and state laws and regulations. Contact Frier Levitt to speak to an experienced attorney regarding proper compliance or defense in investigations and prosecutions.
