What Doctors Need to Know About DEA Administrative Law Procedures
All practicing doctors must register with the Drug Enforcement Administration (DEA) in order to handle and prescribe controlled substances. The DEA, through authority promulgated by the Controlled Substances Act, oversees doctors’ practices with regard to prescribing this medication. If the DEA has cause to believe a doctor has engaged in conduct detrimental to the practice of medicine, then the DEA can take action against a doctor in attempt to revoke his or her prescribing authority. Any action asserted against a doctor by the DEA must be taken seriously as a successful action by the DEA can have serious impact on a doctor’s ability to practice medicine.
If the DEA suspects a doctor is abusing his or her prescribing abilities, the DEA will issue a “show cause order” against the doctor. The show cause order is not a criminal action, but rather an administrative one – meaning the doctor is not being charged with any crime. The show cause order outlines the legal grounds for which the DEA is attempting to revoke or suspend a doctor’s prescribing ability. In this outline, the show cause order must state the reason for the suspected violation on behalf of the doctor. Under the Controlled Substances, there are only certain reasons the DEA may revoke a doctor’s ability to prescribe medication. These reasons are:
- The doctor has been excluded from participation in federally funded heath care program.
- The doctor falsified material information in his or her DEA registration application.
- The doctor has been convicted of either a state or federal violation relating to controlled substances.
- The doctor is engaged in a state action involving controlled substance law and
- The doctor has engaged in any sort of activity that goes against the public interest for prescribing medication.
Once a show cause order is received, the doctor has thirty days to decide whether to fight the accusations or accept them as described. If a doctor disagrees with the reasons for potential registration revocation in the show cause order, the doctor must either request a hearing before an Administrative Law Judge (ALJ) or waive an ALJ hearing and submit a written statement disputing the show cause order instead. Requesting a hearing in front of an ALJ usually proves to be the most beneficial way of discrediting the show cause order. Technically, a doctor also has the right to ignore the show cause order. However, if a doctor does in fact ignore the show cause order, the DEA will issue a final finding based completely on the DEA’s evidence. If a show cause order is ignored, the accusations in the order will usually become final and the doctor must deal with certain revocation of his or her DEA registration.
Sometimes, if the DEA believes a doctor’s conduct is egregious in nature, the DEA can issue an “immediate suspension order” in conjunction with the show cause order. The immediate suspension order, as it sounds, immediately suspends a doctor’s prescribing ability upon receipt. If a doctor just receives a show cause order, the doctor’s prescribing ability is not affected pending the outcome of the hearing. The DEA will issue an immediate suspension order if the DEA feels the doctor’s conduct is an “imminent danger to public health and safety.”
As stated above, most doctors will choose to fight the show cause order by requesting a hearing before an ALJ. If the request for a hearing is timely made within the 30-day deadline, the hearing request will be placed on the docket of an ALJ. Most often, once the hearing is placed on the docket a telephonic conference between the ALJ and counsel for the doctor (should he or she choose to have counsel) will occur. During this pre-hearing conference nothing of substance regarding the merits of the case are discussed, but rather simply scheduling of the hearing is done and scheduling of pre-hearing motion practice is discussed, if needed.
Before the hearing occurs, the doctor must gather evidence to refute the allegations laid out in the show cause order. The evidence needing to be gathered depends on the circumstances and nature of the allegations and experienced defense counsel can guide a doctor as to what evidence is necessary. Also, before the hearing, the doctor and counsel must confer on an appropriate defense strategy to be presented during the hearing. There is usually ample time between requesting a hearing and the actual hearing date. Doctors will not usually be forced to prepare for an ALJ hearing in a condensed amount of time.
On the day of the ALJ hearing, the doctor with his or her counsel along with counsel for the DEA will be present. Although the hearing will resemble a trial, the Administrative Law Judge is the trier of fact. There are no juries for these kinds of hearings. During the hearing, the doctor’s counsel will be able to present his or her defense to the allegations in the show cause order. Evidence, should there be any, may be entered into the record. The counsel for the DEA will also be able to present the DEA’s case as to why the allegations in the show cause order are substantiated and should be made final. Counsel for the DEA may admit evidence as well. Live witnesses (again, should there be any) are allowed and can offer testimony relevant to either side of the case.Once all testimony and evidence has been presented by both sides, the hearing is over and the ALJ takes what has been presented under advisement. A decision on the hearing is not rendered immediately following the end of hearing. Sometimes, though not required, both parties (the doctor and the DEA) submit post hearing written briefs. The purpose of these post-hearing briefs is to highlight and further explain why each side should prevail.
After the ALJ has reviewed all evidence presented at the hearing and post-hearing briefs (if any), the ALJ will render a recommended decision on how the case should be disposed of (whether the doctor or the DEA should prevail). This recommended decision is not final. Once the recommended decision is given, both the doctor and the DEA may file what are called “exceptions” to the decision. These exceptions are filed when one side, or both sides believes the ALJ made a legal or factual error when rendering the recommended decision. No new evidence may be incorporated into the drafted exceptions document. Once the recommended decision has been given and each party has had time to file exceptions to that decision, the decision and exceptions is presented for review to a DEA administrator. The administrator looks at the decision in conjunction with the parties’ exceptions and decides whether to confirm the recommended decision issued by the ALJ or rejecting the ALJ’s decision. At this stage, the decision of the DEA administrator is final. If it is the DEA administrator’s final ruling that the doctor’s DEA registration be revoked, then the registration is in fact, revoked.
Though not advisable, doctors do have the option of waiving an ALJ hearing. If a hearing is waived, then the DEA will present its evidence to the DEA administrator, skipping the step of presenting to the ALJ. No recommended decision is issued by the DEA administrator, only a final decision. If a hearing is waived, the DEA administrator will only hear the DEA’s side regarding the show cause order and most often, the DEA administrator will find in favor of the DEA.
In certain cases, doctors may be able to settle and avoid further show cause ALJ proceedings by engaging in what’s called a “corrective action plan.” Engaging in a corrective action plan is a new addition to DEA administrative proceedings. Only since 2016 have doctors who had this option. A corrective action plan is a detailed plan submitted by the doctor, usually through counsel to the DEA that states how the doctor will address and remediate the issues laid out in the show cause order. The best corrective action plans (the ones most likely to succeed) are the ones that lay out the remedial steps the doctor has already taken to address the show cause issues. The corrective plan, if accepted by the DEA will affirmatory dismiss any further proceedings against the doctor and the case will not proceed to a hearing. If a doctor received an immediate suspension order with his show cause order, he or she is not eligible to submit a corrective action plan and the only way to dispute the allegations is to proceed to a hearing.
Due to the intricacies involved in the ALJ process, any doctor who is served with a show cause order should hire experienced defense counsel to represent his or her interests. A doctor who loses his or her ability to prescribe medication will be severely limited in the practice of medicine. Although the DEA administrative process does allow for doctors to represent themselves (“pro se”), this self-representation is never advisable when your career is on the line.
Get an experienced Corporate Investigation Consulting consultant on your side to advise you on how to proceed regarding the DEA’s administrative law procedures.
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