DActors have wide latitude to prescribe drugs, including potentially dangerous drugs, but even they face limitations. The question is what threshold must doctors cross – and what kind of intent must they have – for their prescription to be considered a crime?
This is a problem directed at the Supreme Court next monthin a case involving two doctors convicted of illegally dispensing opioid painkillers.
The case is already causing concern among pain patient advocates and some health policy experts, who fear a ruling could allow for aggressive lawsuits against prescribers. They warn that such a move could discourage doctors from providing opioids even when warranted, at a time when some pain patients are already losing access to drugs or seeing their doses dangerously reduced. Lawyers are asking the court to clarify that criminal penalties should be reserved for prescribers who knowingly write inappropriate prescriptions.
“What worries us is the downstream effect of removing patients from care and physicians viewing patients as liabilities,” said Kate Nicholson, executive director of the National Pain Advocacy Center.
Oral arguments are scheduled for March 1.
Doctors and other practitioners are free to prescribe some of the drugs that the Controlled Substances Act makes it a crime for the rest of us to dispense. After all, many common drugs — not just opioids, but treatments for conditions like ADHD and anxiety — are covered by law. Yet providers can be found guilty of breaking the law if they prescribe in an unsafe way. In a decision from 1975the court found that doctors could be convicted under the CSA when “their activities fall outside the ordinary scope of professional practice” – when they actually act as drug traffickers.
But in the decades since, the courts have come up with different interpretations of what that means. Some have found that the government must prove that the prescriber intentionally or knowingly violated best practice, allowing doctors to make a “good faith” defense – meaning they were trying to help their patients and didn’t want to prescribe. in a risky way. Other courts have upheld the convictions of physicians convicted of prescribing in a manner found to fall short of accepted standards, regardless of intent.
In recent years, courts have been more likely to take the latter view, given increased scrutiny of opioid prescribers, said Kelly Dineen, director of Creighton University’s health law program. In a brief co-authored by Dineen, she and a group of other health law and policy professors say that controlled substance law “has been weaponized against practitioners in response to the overdose crisis.”
Nearly three decades ago, doctors were overwhelmingly prescribing opioid painkillers, contributing to the continued and growing overdose emergency in the country. Over the past 10 years, efforts to reform prescribing practices have succeeded in reduce drug distribution.
At the same time, however, doctors are increasingly concerned about the legal risks of prescribing high-dose or long-term opioids – and some have stopped providing the treatments altogether. Patients who have taken these drugs for years have sometimes had their prescriptions cut short, prompting some to seek out illicit opioid supplies or commit suicide. Experts disagree on the scale of this problem, but universally say that patients should not face sudden dose reductions or discontinuations – positions echoed by federal health officials.
The concern of the hearing’s defenders is that if prosecutors can indict prescribers without proving they knew they were misprescribing, it could further chill doctors’ willingness to treat suffering patients and exacerbate access problems.
“Honest providers fear being taken for bad actors,” the Pain Advocacy Center wrote in a brief. The center cited surveys showing that many primary care providers will not take new patients on opioids for chronic pain, and those who do fear being targeted by authorities. “High prescribers can be bad actors, but they can also be good providers who appropriately care for patients with significant or complex medical needs,” the brief states.
It’s not that doctors who prescribe incorrectly shouldn’t be punished, Dineen told STAT, but that “we should reserve criminal penalties for people who knowingly engage in criminal acts.” That way, a veritable “pill mill” could be prosecuted, but doctors who prescribe negligently could face other ramifications. They could be sued for malpractice, the government could ban them from prescribing controlled substances, or their state medical agencies could crack down.
In its briefs, the government argued that doctors cannot simply claim that prescribing any amount of controlled substances is legitimate medical practice.
“A physician who errs in the interpretation or application of these standards is not criminally liable so long as he made an objectively reasonable good faith effort to learn and conform to the medical standards,” wrote the government. “A physician who does not take even this modest step, however, has completely abandoned the medical profession and cannot seek shelter.”
Proponents also argue that what constitutes “legitimate medical practice” for prescribing these types of drugs is not always clear. Experts continue to debate whether opioids can treat long-term pain and to what extent they should be used. The Centers for Disease Control and Prevention’s 2016 opioid prescribing guidelines for chronic pain have been cited by policymakers for limiting doses, but the guidelines’ authors pointed out that they had been misapplied and proposed Thursday to soften them.
Patient advocates and health law experts say they got involved in the case not to defend the two doctors, but because of the larger issues at play. Among other groups who submitted briefs in the case, quote the libertarian Cato Institute, which wrote that “the federal government cannot and should not criminalize legitimate and bona fide medical practice.”
The two doctors whose cases are being reviewed are Xiulu Ruan of Alabama, who has been condemned to 21 years in prison in 2017 after being convicted of running what the Justice Department called a pill mill, and Shakeel Kahn of Wyoming, who has been condemned to 25 years in prison in 2019 for crimes including drug distribution resulting in death. Their cases were consolidated for the Supreme Court hearing.
Doctors argued they were acting in good faith in trying to provide care for their patients, while the government urged the court to uphold the convictions.
Ruan and Kahn “simply donned medical gear while acting as drug dealers, lining their pockets distributing addictive, dangerous, and deadly drugs, knowing that their pursuit of profit was at the expense of the health of their patients,” the government wrote in a brief.