Licensing, Regulations, and Hearings Before the DEA
Alex Fisher was contacted by the Albany Law Review to provide a review of the article published in their 78th volume, “Drug Diversion, Administrative Revocation, and Application hearing for Medical and Pharmacy Practitioners: A Primer for Navigating Murky, Drug-Infested Waters.” This article, written by Drug Enforcement Administration (“DEA”) Chief Administrative Law Judge John Mulrooney and DEA law clerk, Andrew Hull, which can be found here, and provides an excellent summary of the administrative process surrounding DEA licenses.
Basis for DEA Discipline
After receiving discipline at the state level on their medical, nurse practitioner, or physician assistant license, many of my clients are often contacted by the DEA regarding agreed-to restrictions on their DEA license, or even the agreed surrender of that license.
The DEA has the authority to suspend, revoke, or otherwise sanction a healthcare provider’s DEA license on the following five bases:
- material falsification in registration application
- conviction relating to a violation of state or federal controlled substance law
- state action against state controlled substance privilege
- exclusion from participation in a federal health care program, and
- the commission of an action that would “render enjoyment of the registration inconsistent with public interest.”
Id. at p. 104-105.
The fifth basis on which the DEA may discipline a healthcare provider’s DEA license, the commission of an action that would “render enjoyment of the registration inconsistent with public interest,” is substantially similar to a common state catchall provision found within the regulations for each profession.
For instance, here in Tennessee, discipline of a licensee by the Board of Medical Examiners is permitted on the grounds of “unprofessional, dishonorable, or unethical conduct.” The DEA’s “inconsistent with public interest” provision also encompasses the discipline of a healthcare provider by their state licensing board, such as the Board of Medical Examiners or Board of Nursing as a legal basis for discipline of a provider’s DEA license. Id. at 111.
In addition to a healthcare provider’s discipline by their professional board, the DEA also considers a criminal conviction relating to manufacturing, distributing, or dispensing of controlled substances as an appropriate basis for the discipline of a provider’s DEA license. Id. at 120.
The DEA also considers “self-abuse of controlled substances and alcohol” and “failure to take steps to prevent against diversion of controlled substances” as potential “public interest” concerns that could lead to the limitation or revocation of a health care provider’s DEA license. Id. at 131. Specifically, the DEA considers “self-abuse of controlled substances and alcohol” and “failure to take steps to prevent against diversion of controlled substances” as potential “public interest” concerns that could lead to the limitation or revocation of a health care provider’s DEA license. Id. at 131.
DEA Administrative Hearing
Within the article, Judge Mulrooney explains in detail the process of an administrative hearing before the DEA. As in most administrative hearings, the burden is on the government to prove that an applicant or licencee has violated a provision of the DEA and that their license should be revoked, disciplined, refused. Id. at 135. Additionally DEA hearings usually take place at one central location—the DEA Hearing Facility in Arlington, Virginia. Id. at 141-42.
As with administrative hearing at the state level, a party appearing before a DEA administrative proceeding may retain an attorney or represent him or herself. Id. at 153. Uniquely, the DEA administrative proceeding also allows a party to be represented by an employee of the party, which contemplates that pharmacies and manufacturers, as the entities themselves, are often the respondent before a DEA administrative proceeding. Id.
At the actual hearing, similar also to state administrative proceedings under the Uniform Administrative Procedures Act in Tennessee, hearsay evidence may be admissible if relevant. Id. at 156.
In concluding, Judge Mulrooney makes an excellent point:
“An unprepared or unschooled counsel can unwittingly choose a tactic or make a concession that can result in the loss of a medical or pharmaceutical practitioner’s livelihood” Id. at 162.
As in any specialized field, but even more so when a practitioner’s ability to prescribe is on the line, it is important for a provider who is facing discipline by the DEA to be represented by counsel who is familiar with and has an intimate knowledge of the process and proceeding before the DEA.
Just as a patient wouldn’t choose a cardiology to perform brain surgery, a healthcare provider should not retain counsel to represent them before the DEA or in any administrative proceeding who is not experienced and specialized in this unique area.