Federal Defense Attorneys Assisting with DEA Application Denials
In order to prescribe or dispense controlled substances as a health care provider in the United States, you must first register your practice, business, or facility with the U.S. Drug Enforcement Administration (DEA). DEA registrations also need to be renewed on an ongoing basis (either yearly or every three years). If the DEA identifies potential grounds to deny your initial or renewal registration, you will need to defend your right to prescribe or dispense medications at a “show cause” hearing before the DEA.
For many providers, DEA registration can be relatively straightforward. But, for others, it can be a lengthy, time-consuming, and stressful process. At Oberheiden, P.C., we bring decades of federal government and private practice experience to representing providers in DEA registrations and renewals, and we can use our vast experience to help you secure your registration as efficiently as possible.
DEA Registration Requirements for Drug Companies, Health Care Providers, and Institutions that Prescribe and Dispense Controlled Substances
The requirements to obtain DEA registration vary depending upon the specific purpose for which registration is sought. DEA registrants are divided into ten categories, and your category will determine your form of registration or renewal application, your application fee, your renewal period, and any special limitations that apply:
- Manufacturing – Registration Form 225, Renewal Form 225a, $3,047 application fee, annual renewal, subject to certain Schedule-specific limitations
- Distributing – Registration Form 225, Renewal Form 225a, $1,523 application fee, annual renewal
- Reverse Distributing – Registration Form 225, Renewal Form 225a, $1,523 application fee, annual renewal
- Dispensing or Instructing – Registration Form 224, Renewal Form 224a, $731 application fee, three-year renewal cycle, research and instructional activities permitted subject to conditions
- Research (Schedule I) – Registration Form 225, Renewal Form 225a, $224 application fee, annual renewal, subject to manufacture and import protocols and limits on distribution
- Research (Schedule (II through V) – Registration Form 225, Renewal Form 225a, $224 application fee, annual renewal, chemical analysis and distribution subject to conditions, manufacture and import subject to conditions
- Narcotic Treatment Programs and Compounding – Registration Form 363, Renewal Form 363a, $244 application fee, annual renewal
- Importing – Registration Form 255, Renewal Form 255a, $1,523 application fee, annual renewal
- Exporting – Registration Form 255, Renewal Form 255a, $1,523 application fee, annual renewal
- Chemical Analysis – Registration Form 255, Renewal Form 255a, $244 application fee, annual renewal, manufacture and import permitted for analysis and instruction, distribution permitted for approved purposes subject to conditions
All of the current registration and renewal application forms are currently available through the DEA’s registration website.
DEA Registration Denials
There are five statutory grounds upon which a DEA registration or renewal application can be denied. Before denying an application, the DEA will issue a “show cause” order, and the applicant will have the opportunity to request a hearing in order to provide information in support of its application. The grounds for denial of a DEA registration or renewal application are:
- Falsifying answers on a DEA registration or renewal application
- Having a felony conviction
- Suspension, revocation, or denial of a state license or registration
- Being subject to exclusion from Medicare or Medicaid (e.g., due to a health care fraud conviction)
- Involvement in activities considered to be “inconsistent with the public interest”
In determining whether activities are “inconsistent with the public interest,” the DEA considers a number of different factors, and the list of factors varies depending upon the category of registration sought to be obtained. For example, for distributors of controlled substances on Schedule I and Schedule II, the factors are:
“(1) maintenance of effective control against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels;
“(2) compliance with applicable State and local law;
“(3) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances;
“(4) past experience in the distribution of controlled substances; and
“(5) such other factors as may be relevant to and consistent with the public health and safety.”
Once you receive a denial of your registration or renewal application from the DEA (in the form of an order to show cause), you have 30 days to respond. Your response can include either: (i) a request for a hearing before an administrative law judge (ALJ), or (ii) a written statement in lieu of a request for hearing. If you fail to request a hearing, your right to a hearing will be deemed waived; and, if you fail to respond at all, the denial of your DEA registration or renewal will become final.
Responding to an Order to Show Cause
Upon receiving an order to show cause, you need to begin formulating your response. The order should specify the reason (or reasons) for the DEA’s denial of your application, and the substance of the order will help you formulate your strategy for overcoming the denial. Whether you choose to request a hearing or submit a written response on the advice of counsel, you will need to thoroughly address the DEA’s concerns in order to secure DEA registration.
When you request a hearing, the burden is on the DEA to prove that your application should be denied. In DEA registration show cause hearings, the standard of proof is “a preponderance of the evidence.” In layman’s terms, this means “more likely than not.” If the ALJ is not convinced that the DEA’s denial should be upheld, then you are entitled to receive your DEA registration.
During a show cause hearing, the ALJ’s role is to review the factual evidence regarding the grounds for the proposed denial of registration. Your attorney and the DEA will each present evidence – which may include both documents and testimony – and both sides will have the opportunity to present oral arguments during opening and closing statements. In many ways, a show cause hearing is comparable to a simplified trial, with both parties presenting their respective cases, responding to one another’s evidence with rebuttals, and having the opportunity to cross-examine any witnesses presented. Counsel for both parties may also present proposed findings of fact and conclusions of law, which the ALJ will consider in rendering his or her decision.
If the ALJ upholds the denial of your DEA registration, the process is not over. The next step is to appeal the decision in federal court.
Criminal Penalties for Submitting False Information on a DEA Registration or Renewal Application
In addition to constituting grounds to deny registration or renewal, submitting falsified information on a DEA registration or renewal application is also a criminal offense. Under 21 U.S.C. Section 843(d), “any person who knowingly or intentionally furnishes false or fraudulent information in the application is subject to a term of imprisonment of not more than 4 years,  a fine . . . of not more than $250,000, or both.”
Additional Considerations Regarding DEA Registrations and Renewals
1. Multiple Locations
If you practice, or dispense controlled-substance medications, from multiple locations a separate registration may be required for each location. The DEA’s registration FAQs state, “A separate registration is required for each principal place of business or professional practice where controlled substances are stored, administered, or dispensed by a person. If a practitioner will only be prescribing from another location(s) situated within the same state, then an additional registration is not necessary.”
2. Relocating Your Medical Practice or Storage Facility
If you relocate your medical practice or the facility where you store controlled-substance medications, you will be required to obtain a new DEA registration. While this is technically referred to as a “modification,” modifications are subject to the same standards and requirements as initial registration applications.
3. Processing Time
According to the DEA, the typical processing time for initial registration applications is four to six weeks, and renewal applications are typically processed in four weeks. However, our experience indicates that wait times may be significantly longer.
4. DEA Number vs. NPI Number
DEA registration numbers and National Provider Identifier (NPI) numbers serve different purposes; and, even if you have an NPI number, you still need a DEA number in order to prescribe or dispense medications that appear on Schedules I through V.
5. Geographic Location
While certain cities and regions are known as “hot spots” for prescription drug diversion and other forms of prescription drug fraud, federal case law has established that the DEA cannot deny a registration or renewal application based solely upon a provider’s geographic location. If your show cause order references your geographic location as partial (or full) grounds for the denial of your application, our attorneys can use this case law to help challenge your denial before an ALJ.
Oberheiden, P.C. | Health Care Fraud Law Attorneys Serving Providers Across the Nation
If you would like to speak with an attorney about your DEA registration application or show cause order, you can contact the law offices of Oberheiden, P.C. for a confidential consultation. Our team includes experienced health care fraud defense attorneys and former federal prosecutors who have decades of experience working directly with the DEA. To schedule an appointment, call our law offices at (888) 519-4897, or send us your contact information and we will be in touch as soon as possible.