The court held that the government must prove beyond a reasonable doubt that the doctor knew or intended to prescribe the drugs in an unauthorized manner.
“We normally would not view such dispensations as inherently illegitimate; we expect, and indeed usually want, doctors to prescribe the medications that their patients need,” Justice Stephen G. Breyer wrote for the court.
In such prosecutions, he continued, “it is the fact that the doctor issued an unauthorized prescription that renders his or her conduct wrongful, not the fact of the dispensation itself.”
The combined cases involve two doctors — Xiulu Ruan and Shakeel Kahn — who were convicted at trial of unlawfully dispensing and distributing drugs and sentenced to more than 20 years in prison. Ruan operated a medical clinic in Alabama and a pharmacy, which made more than $4 million during a four-year period and dispensed nearly 300,000 prescriptions, including many for opioids.
Kahn practiced in Arizona and Wyoming, operating mostly on a cash-only basis and accepting property as payment, including firearms.
The court rejected the government’s request to affirm the convictions and its argument that requiring prosecutors to prove that a doctor knowingly or intentionally acted not as authorized would allow bad actors to escape liability. The justices unanimously returned the physicians’ convictions to the lower courts for further review.
Justice Samuel A. Alito Jr. agreed with his colleagues to return the cases to the lower courts but would have applied a different standard and held that a doctor is acting professionally when the physician writes prescriptions “in good faith.” Alito wrote a concurring opinion to say that the court’s “radical new course” may cause “confusion and disruption.”
The court’s alternate approach, Alito wrote, does not answer the question of whether there is a “good-faith defense” in the prosecutions of physicians.
“How many other affirmative defenses might warrant similar treatment, the Court does not say. It leaves prosecutors, defense attorneys, and the lower courts in the dark. I cannot accept this cavalier treatment of an important question,” wrote Alito, who was joined by Justices Clarence Thomas and Amy Coney Barrett.
The Justice Department declined to comment on the ruling. Former prosecutors said the decision would change the way the government assesses health-care fraud cases by requiring the Justice Department to prove beyond a reasonable doubt that a doctor knew what he or she was doing was wrong at the time the prescription was issued.
“This will have a chilling effect on how the DOJ assesses what cases to prosecute,” Sean B. O’Connell, a former federal prosecutor with health-care fraud experience said in a statement. “The DOJ has aggressively pursued health care fraud in a post-pandemic world and each of these investigations will have to be re-evaluated to determine if the DOJ has enough evidence to meet” the court’s new standard.
The cases are Ruan v. United States and Kahn v. United States