DEA Compliance Consultants & Specialists
Experienced Consultants for Healthcare Providers in DEA Matters
If your business or practice involves prescribing, dispensing, or administering controlled substance medications, your business or practice also inherently involves at least some level of interaction with the U.S. Drug Enforcement Administration (DEA). The DEA is responsible for monitoring the use and sale of prescription medications in the United States, and it is responsible (along with the U.S. Department of Justice (DOJ) and other agencies) for enforcing the nation’s healthcare and criminal laws insofar as they apply to the use and sale of prescription drugs.
For most healthcare providers, their first interaction with the Drug Enforcement Administration comes during the DEA registration process. All providers that deal in prescription medications, including prescribing medications to patients, dispensing prescribed medications, and administering medications in an inpatient setting, are subject to mandatory registration with the DEA. For some providers, the DEA registration process can be fairly straightforward. But, for others, it can involve denials, “show cause” orders, and hearings – and, in some cases, it can even trigger licensing action or a federal investigation.
DEA Compliance Specialists with Substantial Experience
At Oberheiden, P.C., we represent healthcare providers nationwide in all DEA-related matters. This includes registration denials, renewals, and surrenders, as well as audits, inspections, investigations, and federal prosecutions. Unfortunately, while dealing with the DEA’s efforts to ensure compliance should be fairly routine, in many cases seemingly-innocent questions and simple mistakes can lead to drastic consequences. Our goal as DEA compliance consultants is to make sure our clients do not face unwarranted federal action or penalties as a result of any DEA-related matter, and to provide our clients deeply-knowledgeable and efficient legal representation that protects their right to conduct business or practice medicine.
Our healthcare fraud defense team includes attorneys with experience in private healthcare law practice as well as significant previous experience at high levels in the DOJ. As a result, we are able to approach our clients’ DEA matters from all angles and develop comprehensive strategies focused on addressing the issues that matter most to the federal government.
“It is very clear to me that Nick Oberheiden has a deep understanding of health law issues. Nick has been instrumental in managing and resolving many difficult legal matters. He is always relentlessly focused on the critical issues that matter most. Nick is very dedicated and available and always displays a high degree of professionalism. I would not hesitate in recommending Nick for the most important of legal matters.” – Satisfied Client
“Our companies have worked with firms all over the country within various specialties and now use [Oberheiden, P.C.] almost exclusively. [Dr. Nick Oberheiden] represented our companies in some federal law investigations. His guidance and expertise allowed us to continue to concentrate on our core business as he dealt with the complex legal issues.” – Satisfied Client
Types of DEA Matters We Handle
With a national federal healthcare law practice, our firm is available to represent physicians, pharmacists, dentists, clinics, hospitals, and other healthcare providers in a wide range of DEA matters.
DEA audits and inspections are routine, particularly in certain segments of the healthcare industry, but this does not mean that providers can afford to take them lightly. If you or one of your employees has received a DEA Form 82 (Notice of Inspection of Controlled Premises) or an administrative inspection warrant, it is critical that you speak with an experienced defense lawyer or the best DEA compliance consultant before you grant any access or provide any information to the DEA. In most circumstances (any time a DEA Form 82 is presented), providers have the right to informed consent for DEA audits, and you need to make sure you have the information necessary to decide whether it is in your best interests to consent.
During an audit or inspection DEA agents may request patient and billing records, seek to interview your employees, and use a variety of other methods to solicit information. Once again, due to the potential consequences of disclosing information that could be interpreted as evidence of a federal healthcare law violation or criminal offense, you need to make sure you are making smart decisions from the earliest stages of the audit or inspection process.
DEA audit, inspections, and investigations can lead to criminal charges under a broad array of federal statutes. This includes:
- health-care specific laws (such as the Anti-Kickback Statute);
- general anti-fraud laws (such as the False Claims Act); and
- general criminal statutes (such as those that prohibit mail fraud, wire fraud, and the illegal sale or distribution of controlled substances due to the Controlled Substances Act).
In most cases, a DEA investigation has the potential to be either civil or criminal in nature. If federal prosecutors are not yet pursuing criminal charges, our first priority will be to keep your case civil in nature. However, if criminal charges (and the potential for federal imprisonment) are unavoidable, we will work quickly and strategically to mitigate the consequences of your DEA investigation – and, if possible, obtain a favorable resolution prior to trial.
If your business or practice is facing any type of disciplinary action by the DEA, your defense needs to be your top priority. The consequences of a DEA inquiry into your business or practice can be severe; and, even if you do not face penalties from the DEA you could still be facing the potential for adverse licensing action, federal healthcare benefit program exclusion, and other collateral consequences that could be devastating to your business or practice. As DEA compliance specialists, we are aware of these concerns, and we understand their implications for licensed medical providers and DEA registrants. However, these are the very issues that can be easily overlooked by attorneys who focus their practices in other areas – and lack specific experience in healthcare fraud defense and DEA regulations and regulatory compliance.
Our attorneys routinely assist clients with the DEA registration and renewal process, and we have intimate knowledge of the requirements for submitting a successful DEA Form 224 (for initial registration) or DEA Form 224a (for renewal registration). While the registration process is supposed to take no more than four to six weeks, it is not unusual for providers to go months without hearing from the DEA – only to then find out that their registration applications have been denied.
When the DEA denies a registration application, it must issue an order to show cause (or “show cause” order) to the applicant. The show cause order will identify one or more of the following as the grounds for denial:
- False information in the application
- A felony conviction
- A state license or registration suspension, revocation, or denial
- Exclusion from Medicare or Medicaid
- Acts the DEA considers “inconsistent with the public interest”
If you receive a show cause order, you have the right to request a hearing and challenge the denial of your DEA registration. Due to the complexities and potential consequences involved, it is strongly recommended that providers who have been denied DEA registration hire the best federal defense representation.
If the DEA has asked you to voluntarily surrender your registration, you need to make sure you have a clear understanding of your legal rights. Most importantly, you are under no obligation to voluntarily surrender your registration at any stage during a DEA audit or investigation. You need to be aware of the consequences of voluntarily surrendering your DEA registration as well. A voluntary surrender could result in:
- an immediate inability to conduct your practice;
- adverse action by state licensing and regulatory boards; and
- ineligibility for future DEA registration.
For more information about what to do a DEA agent has asked you to surrender your registration, you can contact us for a free and confidential consultation.
DEA registration suspensions and revocations can result from a variety of different factors, and registrants must take informed and strategic action to protect their registrations when facing an inquiry from the DEA. Our attorneys are thoroughly familiar with the issues that are – and aren’t – grounds for suspension or revocation. We can help protect your right to practice or conduct business if the DEA is seeking to suspend or revoke your registration.
Answers to FAQs about DEA Registration, Audits, Inspections, and Enforcement
Q: Why is my business or practice being audited by the DEA?
There are three primary reasons why the DEA will audit a registered healthcare provider. If your business or practice is being audited, it is important to determine the reason for the audit, as certain factors can make it more likely that you will face an investigation that could lead to civil or criminal charges. In most cases, a DEA audit will be the result of:
- a random inspection (most providers are audited once every three years, but providers that deal in certain prescription medications may be audited more often);
- an apparent pattern of abnormal prescription practices, based upon an analysis of comparable healthcare providers; or,
- a tip received from a practitioner, pharmacist, or patient indicating possible prescription drug fraud or violations of federal regulations other federal offenses.
Q: What does it mean if my DEA registration application was denied on the grounds that registration would be “inconsistent with the public interest”?
If you have received a show cause order stating that your registration would be “inconsistent with the public interest,” this can mean any of the following things:
- The DEA is alleging that you have failed to maintain effective controls against prescription drug diversion.
- The DEA believes you have insufficient experience in the distribution of controlled substances.
- You have a prior federal or state conviction for an offense involving a controlled substance.
- The DEA has identified other factors indicating that your registration would be harmful to public health and safety.
Receiving a show cause order based upon registration being “inconsistent with the public interest” is not a death sentence for your application, but you will need to develop and execute a strategy for overcoming the alleged grounds for denial. Our DEA compliance consulting services can help you understand the issues underlying your registration denial and take responsive action accordingly.
Q: What are the potential consequences of a DEA investigation?
The penalties for prescription-related federal offenses vary depending upon: (i) the specific statute(s) at issue, and (ii) whether your case is civil or criminal in nature. Generally speaking, however, prescription drug fraud and other offenses carry severe penalties, including the potential for exorbitant fines, recoupments, treble (triple) damages, federal benefit program exclusion, and federal imprisonment.
Schedule a Free and Confidential Consultation With Qualified Federal Attorneys or DEA Compliance Consultant Today
If you need experienced legal representation for a DEA matter affecting your healthcare business or medical practice, we urge you to contact us promptly to arrange a free consultation. To speak with a member of our healthcare fraud defense team in confidence, please call 888-680-1745 or get in touch online today.
Further Information About DEA Compliance
- Can I Still Prescribe Medications While My DEA Renewal is Pending?
- DEA Administrative Audit at a Physician’s Office
- DEA Applications and Denials
- DEA Compliance and Defense for Labs and Pharmacies: Importing Drugs from China
- DEA Disciplinary Actions
- DEA Diversion Investigations — Red Flags for Pharmacies that Dispense Opioid Medications
- DEA Investigations Against Doctors and Pharmacies
- DEA Letter of Admonition
- DEA Surrenders
- DEA Suspensions and Revocations
- Pharmacy DEA Compliance: Is Your Pharmacy DSCSA Compliant?