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On June 27, 2022, the United States Supreme Court sided with prescribers in holding the Government to a higher burden of proof regarding the subjective intent of medical practitioners. The case of Ruan v. United States interpreted the Controlled Substances Act, (21 U.S.C. §841), to require that a Federal prosecutor, in order to obtain a conviction, must demonstrate that a prescriber knowingly or intentionally acted in a manner not “as authorized” under the Act.

The Ruan decision represents a major victory for prescribers caught in the crosshairs of a Federal probe. While the Ruan decision is worth reading (available here), its applicability to licensees outside the context of criminal inquiries, including reviews by the State Medical Board of Ohio, will likely be much more limited.

Several facts must be noted when evaluating the applicability of Ruan to any specific case. Preliminarily, Ruan dealt with Federal statutes, while the jurisdiction of the Ohio Medical Board is limited to the Ohio Medical Practice Act.  Another important distinction was the constitutionally protected interests at issue and the standard of proof for each. In a criminal case, a physician faces the possibility of incarceration (i.e., their liberty). Therefore, courts impose the highest standard of proof, beyond reasonable doubt. During a Medical Board case, a physician faces the loss of a license and a fine, both of which are considered “property” interests only. Therefore, in administrative proceedings, courts require a lower (“preponderance of the evidence”) burden of proof.

Ruan’s rational could be analogous to Ohio Board actions in that each prescription must be issued for a legitimate medical purpose.  Ohio Administrative Code 4731-11-02. Prescribers who authorize prescriptions for non-legitimate purposes, or more commonly, who fail to adequately document the legitimate medical purpose (including the prescriber’s rational), face discipline by the Board.

In the wake of Ruan, licensed practitioners should not assume that pure intentions will absolve them of administrative liability before the Ohio Medical Board. While one could argue that the rational of Ruan should apply to physicians facing potential sanctions before the Ohio Medical Board, the Board has no obligation to hold itself to the higher standard of proof. Moreover, during an Ohio Medical Board hearing, evidence of intent often depend upon what is documented in the medical records. Failing to adequately documents the prescriber’s rational for prescribing, regardless of the prescriber’s intent, often is enough to support a violation of Ohio’s prescribing laws.   

If you have questions regarding the Medical Board Rules or the Board’s administrative hearing process, please contact an attorney a Graff & McGovern, LPA representative. Levi Tkach is available to take your call at 614-228-5800, extension 4 and at levi@grafflaw.com