Enacted in 1970, the main objective of the CSA was to combat drug abuse and controlling legitimate and illegitimate traffic in controlled substances.
Only licensed medical practitioners who are registered with the DEA are authorized to prescribe controlled substances listed in Schedules II-V to patients; such prescriptions may only be issued by a practitioner who is “acting in the usual course of his professional practice,” and for a “legitimate medical purpose” (C.F.R. 1306.04).
The CSA authorizes the DEA administrator to suspend or revoke a physician’s prescription privileges upon a finding that he/she has “committed such acts as would render his/her registration. … inconsistent with the public interest” (Gonzales v. Oregon, 546 U.S. 243 (2006)).
This is a much lower standard than the standard applicable to criminal cases. Thus, a practitioner could face losing their DEA privileges even though he/she is acquitted in a criminal court.
When deciding whether a practitioner’s registration is in the public interest, the Attorney General shall consider:
- The recommendation of the appropriate state licensing board or professional disciplinary authority;
- The applicant’s experience in dispensing, or conducting research with respect to controlled substances;
- The applicant’s conviction record under federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances;
- Compliance with the applicable state, federal, or local laws relating to controlled substances; and
- Such other conduct which may threaten public health and safety (21 U.S.C.S. 832(f)).
The CSA also provides criminal prosecution for illicit possession, manufacture, or distribution of controlled substances.
In order to avoid criminal prosecution for a violation of the CSA, a physician must always “[act] in the usual course of his professional practice,” and for a “legitimate medical purpose” (21 U.S.C. 801 et seq.).
Federal regulations offer very little interpretation regarding the definition of “legitimate medical purpose,” and certainly do not narrow the standard as we see in Michigan. In 2005, the Attorney General issued guidance on the term, “legitimate medical purpose,” which simply mirrored the definition used in the CSA.
The U.S. Supreme Court has taken a similar approach stating that “registered physicians can be prosecuted under [the CSA] when their activities fall outside the usual course of professional practice” without offering any additional guidance. (United States v. Moore, 423 U.S. 122, 96 S. Ct. 335 (1975)).
Fifth Amendment challenges have been made to the vague wording of the CSA but have been unsuccessful in other Circuits (United States v. Smith, F.3d 639, 653 (8th Cir. 2009)).
In absence of clear guidance, the 6th U.S. Circuit Court of Appeals has wisely endorsed a broad approach to determining what conduct falls outside the accepted bounds of professional practice so as to constitute a CSA violation, eschewing a pre-established list of prohibited acts in favor of a case-by-case approach (United States v. Kirk, 584 F.2d 773, 784 (6th Cir. 1978)).
Recent 6th Circuit opinions have applied the subjective “good faith” standard; “good faith in this context means good intentions and an honest exercise of professional judgment as to a patient’s medical needs,” “it means the defendant acted in accordance with what he reasonably believed to be proper medical practice” (United States v. Volkman, 736 F.3d 1013, 1026 (6th Cir. 2013)).
While this is problematic for practitioners, seeking clear guidance on what constitutes a criminal departure under the CSA, the 6th Circuit considers:
- Whether adequate physical exams were conducted;
- Whether tests were conducted;
- Regulation of the dosage of narcotics;
- Terms and method of payment;
- If a complete medical history was taken;
- Whether informed consent was given;
- Prescriptions issued for use by one patient but used for another;
- Admissions by patients that drugs would be used for a nonmedical purpose;
- Falsification of patient records; and
- The number of prescriptions written in a short amount of time.
(See United States v. Binder, 2014 U.S. Dist. LEXIS 84719, 2014 WL 2757393 (E.D. Mich. June 5, 2014), quoting United States v. Varma, 691 F.2d 460, 464 n.2 (10th Cir. 1982).)
The items above only constitute a short list of what the factors the 6th Circuit has used to determine that a physician acted in “good faith” and is not an exhaustive list. Physicians, dentists, pharmacists, veterinarians, and other prescribers face significant penalties for stepping outside what has increasingly become a very blurry line.
Physicians must always monitor their prescription habits and seek the counsel of an attorney knowledgeable in professional licensing, the criminal defense of health care providers, and the standard of care to ensure that their actions and procedures are in compliance with current statutes and regulations.