On March 1, the Supreme Court will hear oral arguments on a serious issue facing medical practitioners: When can their care turn criminal in the context of prescribing opioids? The Court’s decision will have broad implications not only for the many physicians and other practitioners who prescribe opioids, but also for the millions of patients who suffer from pain every day. The inconsistent decisions from lower courts on this issue has left good doctors wondering when their judgment may be called into question and their freedom on the line.
Dinsmore attorneys are closely monitoring this issue and will follow the oral arguments before the Supreme Court. We will keep clients apprised of any major developments that may affect their businesses or health care practices.
Medical practitioners derive their prescribing authority from the Controlled Substances Act (CSA), which makes it unlawful “except as authorized … for any person [to] knowingly or intentionally … distribute … a controlled substance.”[i] Drug Enforcement Administration regulations further mandate that prescriptions “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”[ii] Innocent prescribing mistakes, differences of opinion on prescribing, or even negligence, should not amount to criminal liability.
In 1975, the Supreme Court held that doctors could be convicted under the CSA when “their activities fall outside the usual course of professional practice.”[iii] But in the decades since, courts have interpreted that decision differently. Some have adopted a subjective good-faith standard and hold that practitioners cannot be convicted if they sincerely and honestly believe that their prescriptions were within the usual course of professional practice.[iv] Others have adopted an objective good-faith standard and hold that a practitioner cannot be convicted if they “reasonably believed” that their prescription was within the usual course of professional practice.[v] A minority of courts have rejected any consideration of good faith and found it irrelevant to criminal liability.[vi]
Given that the statute requires the “knowingly or intentionally” unauthorized distribution of a controlled substance, the Supreme Court is expected to permit the good-faith defense. The only question remains: To what extent? If a doctor honestly believed the prescription was for a legitimate medical purpose, should that absolve the conduct, or should the belief be judged on an objective standard?
Amicus briefs filed with the Supreme Court by multiple organizations have come out in strong support of physicians, advocating for a subjective good-faith standard given the considerable debate in the medical community about what constitutes “the usual course of professional practice” when prescribing opioids. “[T]here is no unitary standard or broadly applicable protocol for treating pain,” the National Pain Advocacy Center wrote. “Indeed, no consensus medical opinion exists even on an upper limit for opioid prescriptions, in volume or dosage,” the nonprofit organization Compassion & Choices noted.
The concern among advocates is that a standard based on “generally accepted practice” and objective belief will lead to over-deterrence and chill the practice of pain medicine. The fear of harsh criminal penalties has already led many providers to refuse to treat patients with chronic pain and “subject patients to dangerous opioid cessation practices that may actually increase their risk of death,” wrote the National Pain Advocacy Center. Another concern is that in the absence of a robust good-faith defense, “[p]atient abandonment will grow more widespread as practitioners avoid legal scrutiny.”
Advocates argue exposing providers to criminal liability for nothing more than a deviation from accepted medical standards will not solve the opioid crisis. “Incarceration of physicians who treat pain does not eliminate the pain and the need to treat it,” the Association of American Physicians and Surgeons wrote in their brief.
In its briefs, the government argued a provider who makes no objectively reasonable attempt to comply with medical norms violates the law. The CSA “does not permit a physician to simply decide for himself that any manner or volume of drug distribution is ‘medicine,’” the government wrote.
[i] 21 U.S.C. § 841(a)(a)
[ii] 21 C.F.R. § 1306.04(a)
[iii] 423 U.S. 122, 124 (1975).
[iv] See, e.g., United States v. Sabean, 885 F.3d 27, (1st Cir. 2018) (reasoning that “a sincere effort to act in accordance with proper medical practice, even if flawed, could not undergird a guilty verdict so long as the defendant had acted in good faith.”) (internal quotations omitted); (United States v. Feingold, 454 F.3d 1001, 1007-08 (9th Cir. 2006) (quoting United States v. Rosenberg, 515 F.2d 190 (9th Cir. 1975)) (explaining “‘the jury [must] look into [a practitioner’s] mind to determine whether he prescribed the pills for what he thought was a medical purpose or whether he was passing out the pills to anyone who asked for them’” (emphasis added).
[v] See e.g., United States v. Wexler, 522 F.3d 194, 205 (2d Cir. 2008) (explaining that good faith in the context of a §841 prosecution “means that the doctor acted in accord with what he should have reasonably believed to be proper medical practice”); (United States v. Hurwitz, 459 F.3d 463, 479 (4th Cir. 2006) (holding that in a § 841 prosecution against a doctor, “the inquiry into the doctor’s good faith in treating his patients . . . must be an objective one”); United States v. Volkman, 797 F.3d 377, 387-88 (6th Cir. 2015) (explaining a physician cannot be convicted if he “dispenses a drug in good faith,” where good faith “means that the defendant acted in accordance with what he reasonably believed to be proper medical practice”).
[vi] United States v. Enmon, 686 F. App’x 769, 773 (11th Cir. 2017) (per curiam).
© 2022 Dinsmore & Shohl LLP. All rights reserved.National Law Review, Volume XII, Number 60