DEA registration defense is a highly complex area of law, fraught with pitfalls for the inexperienced attorney. Bad advice can cost you your practice, your freedom, your financial resources — and your registration.
It is important to choose counsel highly experienced in DEA registration defense. If you are a healthcare provider and you dispense or prescribe controlled substances, you must comply with the stringent Federal and State requirements that regulate the prescribing and dispensing of such substances.
Failure to comply with these rules may trigger an investigation or audit that will not only carry monetary fines but threaten the health care providers’ DEA registration and state license.
According to the DEA, it regularly audits pharmacies and physician practices for compliance with the Controlled Substances Act (“CSA”). When it finds non-compliance with the CSA, it takes action through a system of judicial actions, including criminal prosecution, civil action, or administrative action seeking revocation or denial of a registration — or any combination of the three.
While this is true, it is a bit of an understatement such action is the result of random inspections. Generally, investigations and audits are targeted, so physicians or pharmacists must treat an encounter with the DEA as more than just mere chance, but a well-planned out encounter done for investigative purposes.
If you are being audited by the DEA, you should assume that the DEA already has a suspicion that you have violated at least one aspect of the controlled substances act. If you are facing action by the DEA it is likely because you were the target of a DEA investigation. If DEA diversion investigators are at your practice or pharmacy performing an audit, they already at least have some knowledge about you and your practice.
Generally, the DEA collects information about a physician or pharmacist prior to conducting an audit by reviewing prescription drug monitoring system software. The DEA looks for signals in the data that could suggest the need for a DEA audit. When those signals are present, they will attempt to do an administrative inspection.
You may also be a target because your patients exhibit “red flags.”
The DEA may tell you that it has the power to revoke your registration, or that if you don’t sign a DEA 104 (voluntary surrender), it has the power to revoke.
This is false. DEA agents and diversion investigators do not have the power to revoke a registration.
Only the DEA administrator has the power to revoke your registration, and the administrator can only do so if he/she complies with the requirements of due process.
To start the process, the DEA will file an “order to show cause” against your registration. This is a notice that is provided to you, stating that the DEA intends to revoke your registration unless you “show cause” as to why it should not be revoked. Before this happens, your attorney should have engaged in extensive correspondence/negotiation with the DEA to attempt to show compliance or resolve the allegations.
If you request a hearing, you will have the opportunity to “show cause” in front of a DEA administrative law judge that your registration should not be revoked. You should retain counsel to file the response and defend you at the hearing. This hearing can take place in Arlington, Virginia, or near your pharmacy/practice depending on the judge’s ruling.
After the hearing, the judge will issue a proposal for decision which provides a recommendation to the DEA administrator. The administrator generally upholds the recommendation of the judge, and you have the opportunity to appeal that decision to a federal court.
If you are facing a DEA investigation or believe the DEA has initiated criminal, civil, or administrative action against you, there are a few simple steps you can take now to greatly improve your chances of a successful outcome:
You must obtain an attorney knowledgeable with the nuance of DEA law. DEA regulations are complex and violation of a single regulation (depending on the severity) can cost tens of thousands in civil penalties, result in license revocation, and lead to a criminal investigation. Bad advice may cost you your practice.
Make sure you choose an experienced firm that has practiced in this arena frequently. Chapman Law Group’s national DEA defense attorneys have taught hundreds of hours of CME credits on DEA compliance. Our attorneys have represented hundreds of physicians, pharmacies, and other prescribers across the U.S. in DEA proceedings and during DEA investigations.
Many pharmacists, physicians or other prescribers think that obtaining an attorney to deal with the DEA will make them look guilty. This is not the case.
Every large and mid-size pharmacy, distributor or physician practice group speaks to the DEA only through their DEA attorney or compliance personnel. This is common among businesses that appreciate the fact that only a knowledgeable DEA attorney is equipped to understand the legal and regulatory framework sufficiently to correspond with the DEA.
In addition, every time a pharmacist or physician speaks with the DEA, that information is filed in a report and can be used later in court proceedings. It is vital that every statement made to the DEA is submitted through counsel to avoid costly misunderstandings.
The DEA also appreciates correspondence through counsel because, if you retain a DEA attorney who is knowledgeable with DEA matters, rapport is easily established between diversion investigators, agents and DEA attorneys. This can can streamline the process of responding to requests.
If the DEA asks you to sign a voluntary surrender (DEA Form 104), it is imperative that you seek the advice of counsel before doing so. There are almost never circumstances where this is beneficial for the physician or pharmacy, and reobtaining your registration may take years and thousands of dollars.
Because the pharmaceutical industry is a heavily regulated field, it is always best to self-assess and determine how we can convince the DEA that 1) we did not violate regulations, and 2) we will not violate regulations in the future. This is the primary concern of the DEA.
Whether it’s a pharmacy or physician’s practice, the lawyers at Chapman Law Group typically conduct a DEA compliance inspection initially to determine the extent of any potential problems. If your documentation is insufficient, we help you correct it. If audits of dispensing records reveal inaccurate data, we can help you find the root cause of the result.
As a full-service healthcare law firm, we will focus on fixing any systemic issues while simultaneously aggressively defending any false allegations against your practice or pharmacy.
Let’s be honest: we live in a world where investigations are driven by data. DEA investigators review data prior to inspecting your practice or pharmacy. The DEA makes decisions about what to target based on the number of controlled substances dispensed.
Pharmacy wholesalers make decisions about which clients to cut off based on data, and pharmacies make decisions on which physicians’ prescriptions they will not fill based on data.
Therefore, it’s imperative that you …
After you have assessed your pharmacy or practice, you will need to implement policies and procedures to ensure you and your staff maintain compliance and continue to improve.
21 U.S.C. 824(c)(2)(c) requires the DEA to consider a corrective action plan prior to taking administrative action. This means that if the DEA is considering administrative action and you submit a corrective action plan to the DEA administrator, the administrator must consider the corrective action plan before taking administrative action.
If the DEA does take administrative action, the corrective action plan can be submitted as evidence to show that you should retain your DEA registration. If you are facing a criminal investigation or were the subject of a DEA administrative inspection or search warrant, you may be concerned that submitting a corrective action plan is an admission of wrongdoing. If this is not the case, your attorney can submit it in such a way that it cannot be used as evidence against you in a later proceeding. This is why having an attorney knowledgeable in DEA matters is vitally important.
After you have taken every step to ensure compliance, it is necessary to aggressively defend any allegations of unlawful conduct against you or your pharmacy/practice.
Whether the allegations are civil, criminal, or administrative in nature, you must develop an investigation plan that produces solid evidence to present at trial or the DEA hearing.
If the case involves prescribing of controlled substances, your counsel will need to interview patients, obtain medical records, obtain experts, and produce data to show that you prescribed “for a legitimate medical purpose” and “in the usual course of professional practice.”
If the case involves dispensing, you will need to review dispensing data that you have resolved and documented any potential “DEA red flags” associated with the prescriptions filled. This process is not easy and requires review of thousands of pages of data (depending on the size of the pharmacy or practice).
If your conduct is supported in the data and by an expert, you should not be concerned about aggressively defending your actions in order to obtain a dismissal or positive verdict during a DEA hearing or trial.
If you are not knowledgeable about DEA requirements, the DEA regulations that you should be familiar with are:
At Chapman Law Group, our DEA and federal criminal defense attorneys are dedicated to defending prescribers and dispensers nationwide against actions such as DEA investigations and audits, DEA raids, DEA registration applications and denials, and DEA registration suspension and revocation issues nationwide.
We also work with prescribers and dispensers to advise them on state and federal regulations surrounding controlled substances to ensure compliance and prevent DEA investigations, enforcement action, and criminal charges.
Our national DEA attorneys are experienced in defending DEA registrants both during DEA investigations and in subsequent DEA action if noncompliance with the CSA is found. When an investigation or DEA audit is initiated, we work with clients to respond to DEA complaints, demonstrate compliance and negotiate agreements between the DEA and client to ensure minimal impact to their DEA Certification and license and reduce penalties.
We serve healthcare providers nationwide, with four national law offices: Detroit, Michigan; Miami and Sarasota, Florida; and Los Angeles/Southern California. Contact us today.
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