The Supreme Court held that a medical provider who prescribes controlled medications can only be found criminally liable for unlawfully prescribing if he or she knowingly or intentionally prescribes in an unauthorized manner.

A Culpable Mental State: The Right Decision for Specialized Care

The Ruan decision comes as a relief to both providers of pain care and to people living with pain, as prescribers have often reported in recent years that they have been deterred from prescribing controlled substances to patients for whom they are indicated, against their best medical judgement, for fear of unwarranted prosecution.²˒³ In part, this fear is exactly what the Court was attempting to mitigate with their ruling, as Justice Stephen Breyer wrote in his opinion that requiring a culpable mental state in regard to CSA cases “helps to diminish the risk of ‘overdeterrence,’ ie. punishing acceptable and beneficial conduct that lies close to, but on the permissible side of, the criminal line.”

Therefore, if a physician is charged with a violation of the CSA, their defense is to show:

  1. they are authorized under the CSA
  2. they were practicing within their profession’s standard medical practice

From a medical and legal perspective, “standard medical practice” or “standard of care” shifts in accordance with each individual practitioner’s specialty, patient make up, resource availability, geographic location, and more.⁴

According to Barnes, this ruling illustrates that the Court has decided that physicians need to feel confident in prescribing to their patients with complex conditions — as providing specialized treatment for complex patients is exactly why specialists exist.⁵

A bit more explanation for the Court’s reasoning was offered by Justice Samuel Alito in his concurring opinion. Discussing the phrase “in the course of professional practice,” he states that to “practice medicine” a practitioner must act for a medical purpose, such as aiming to prevent, cure, or alleviate the symptoms of a disease or injury. They must also believe that the treatment is a medically legitimate means of treatment. However, according to Justice Alito, “…acting ‘as a physician’ does not invariably mean acting as a good physician […] A doctor who makes negligent or even reckless mistakes in prescribing is still ‘acting as a doctor’ — he or she is simply acting as a bad doctor.”

Investigators to Pivot to Professional Discipline, Negligence, and Fraud

To Justice Alito’s point, the United States has optimally designed venues for dealing with the aforementioned “bad doctor” (or any type of licensed healthcare provider) whose actions are questionable but do not reach the level of criminal behavior: licensing boards.

Licensing boards are specifically designed to take into consideration the variable standards of care among the many types of professions and specialists practicing within their own unique geographic settings. Consisting of highly skilled professionals from within each specific discipline and locale, state licensing boards are far more capable than the courts of determining whether or not a healthcare provider has failed to meet their standard of care — and whether they should be able to continue to practice in the future.

What’s more, while prosecutors may be unable to pursue “drug dealing” or “drug trafficking” charges without proving criminal intent beyond a reasonable doubt, they may still be able to prove other criminal charges, such as conspiracy to commit healthcare fraud (though it is not entirely clear how Ruan’s interpretation of “knowingly or intentionally” will impact other healthcare laws, such as the Anti-Kickback Statute, which itself uses a “knowing and willful” standard⁷).

Future Implications

The Impact of Ruan on Past, Current, and Future Prosecutions

For those who have previously been convicted of violating the CSA, it is highly unlikely that a conviction will be overturned (unless an appellate waiver has been signed, in which case one should consult an attorney regarding options).

  1. did not intend to violate the CSA
  2. sought compliance advice after learning of potential infractions
  3. are implementing that compliance advice⁵

According to Mr. Chapman, compliance enhancement has a huge impact on continued prosecution.

Going forward, based on the intent requirement set out by the Court, the government will be aiming to prove beyond a reasonable doubt that the prescriber knowingly or intentionally prescribed for a non-medical purpose when investigating potential CSA violations — and they have already signaled their intention to do just that. Mere days after Ruan was decided, the Department of Justice created a new strike force in New England to focus on illegal opioid prescriptions.⁸ With a mission to investigate the alleged illegal distribution of prescription opioids and to target alleged criminal conduct by all medical professionals, the New England Prescription Opioid (NEPO) Strike Force will bring together resources from the Health Care Fraud Unit in the Criminal Division’s Fraud Section; US Attorneys’ offices for three federal districts; and law enforcement partners from the Office of the Inspector General, DEA, and the FBI.

  1. Xiulu Ruan v United States. No. 20-1410 (Slip Opinion). Supreme Court of the United States. Argued March 1, 2022. Decided June 27, 2022. Available at: Accessed August 1, 2022.
  2. Human Rights Watch. Not allowed to be compassionate: Chronic pain, the overdose crisis, and unintended harms in the US. December 2018. Available at: Accessed August 1, 2022.
  3. Nicholson K. Good news from the National Pain Advocacy Center! June 28, 2022. Available at: Accessed August 1, 2022.
  4. Cooke BK, Worsham E, Reisfield GM. The Elusive Standard of Care. J Am Acad Psychiatry Law. 2017;45(3):358-364. Available at: Accessed August 1, 2022.
  5. The recent ruling and the implications for opioid prescribers: Xiulu Ruan v. United States (webinar). J Opioid Management. July 19, 2022. Slides available at: Accessed August 1, 2022.
  6. Oberheiden N. U.S. Supreme Court Overturns Doctors’ Opioid Convictions in Ruan v. United States, Paving the Way for Additional Appeals. JD Supra. July 5, 2022. Available at: Accessed August 1, 2022.
  7. Sternberg JM, Namkung AI. Supreme Court Ruling Finds “Strong” Mens Rea Requirement for Prosecution Under the CSA. Holland & Knight. July 6, 2022. Available at: Accessed August 1, 2022.
  8. Kingman MK. New Illegal Opioid Prescription Task Force Signals Medical Professionals Will Continue to be Targets of Criminal Investigations. JD Supra. July 8, 2022. Available at: