We Assist Practitioners, Hospitals, Pharmacies, and Other Clients with All Aspects of Compliance
DEA Compliance Team Lead – Timothy E. Allen | Former Special Agent (U.S. Secret Service & DOJ-OIG)
While most people know the U.S. Drug Enforcement Administration (DEA) as the agency responsible for fighting the country’s war on drugs, those in the healthcare industry know the DEA for very different reasons. The DEA maintains comprehensive oversight of the healthcare industry, and entities ranging from private physician’s practices to pharmacy groups and hospital systems are subject to comprehensive DEA compliance obligations.
Our firm assists healthcare entities with all aspects of DEA compliance. From securing (and maintaining) DEA registration to managing drug inventory and electronic prescription records, DEA compliance impacts numerous aspects of providers’ and other entities’ operations. As former DEA Special Agents, our consultants understand the burdens of compliance—as well as the risks of noncompliance—and they take a comprehensive approach to helping our clients meet their obligations on an ongoing basis.
Understanding Your DEA Compliance Obligations
Within the healthcare industry, DEA compliance means different things to different entities. While providers, pharmacies, manufacturers, and other businesses share many of the same obligations, entities in each sector face unique compliance obligations as well. To establish compliance, entities must first understand what is required, and then they can develop and implement tailored policies and procedures that address their specific needs.
With this in mind, the umbrella of DEA compliance covers an extremely broad range of statutory and regulatory requirements. Some examples of common DEA compliance obligations include:
- Controlled Substances Act (CSA) compliance
- Drug Supply Chain Security Act (DSCSA) compliance
- Electronic prescription compliance
- DEA registration and renewal compliance
- Drug packaging and labeling compliance
- Drug ordering, inventory, transfer, and disposal compliance
- Drug diversion prevention
- Anti-Kickback Statute (AKS) and Stark Law compliance
- Documentation and recordkeeping
- DEA audits, inspections, and investigations
Even within these areas of DEA compliance, different entities’ obligations will vary. The CSA, for example, is an extraordinarily broad statute that the DEA has implemented through a comprehensive set of detailed and complex regulations. Manufacturers’ and providers’ obligations under the CSA are vastly different, as are the obligations of pharmacies and other entities. Similarly, regarding electronic prescription compliance and drug diversion prevention, pharmacies’ and providers’ compliance programs will look very different—even though they will broadly cover the same subject matter.
These complexities underscore the importance of engaging a DEA compliance consulting firm. The substantial majority of manufacturers, pharmacies, healthcare providers, and other entities do not have the in-house resources needed to establish and maintain an effective DEA compliance program independently. At Corporate Investigation Consulting, we offer the advice and insights our clients need, and we work closely with our clients to foster cultures of compliance and implement policies and procedures capable of withstanding DEA scrutiny.
Our DEA Compliance Consulting Services
We provide comprehensive and custom DEA compliance consulting for drug manufacturers, pharmacies, healthcare providers, and other clients. Our consulting services include:
DEA Registration Consulting
We assist our clients with filing DEA Form 224 (initial registration) or DEA Form 224a (registration renewal). This includes not only preparing the application form itself, but also ensuring that our clients are prepared to meet all requirements for securing DEA approval. We have significant experience consulting with clients regarding “show cause” orders as well, and our consultants have helped many clients secure DEA registration and renewal following preliminary denials.
In addition to securing and maintaining DEA registration, we also consult with clients facing requests for voluntary surrender, suspensions, and revocations. If your business’s or practice’s DEA registration is in jeopardy, our consultants can assess the circumstances at hand and help you pursue an informed and strategic path forward.
DEA Compliance Program Development
As discussed above, developing an effective DEA compliance program requires an intimate understanding of an entity’s specific compliance obligations. We work closely with our clients’ key stakeholders to evaluate their compliance needs and craft custom solutions. We ensure not only that our clients’ DEA compliance programs are comprehensive, but also that they do not address impertinent issues or create internal confusion regarding what is and is not necessary.
DEA Compliance Program Implementation
Effective DEA compliance program implementation is essential. Without implementation, a DEA compliance program is not only useless, but it can even work to the company’s or practice’s detriment. If DEA agents discover that an entity has adopted but failed to implement a compliance program, this will raise red flags and almost certainly lead to further scrutiny.
DEA compliance program implementation is itself a multistep process. Implementation involves compliance program dissemination, training, and adaptation of internal protocols—among other measures. We guide our clients through the entire implementation process, and our consultants work alongside our clients to ensure that they maintain effective implementation on an ongoing basis.
DEA Compliance Documentation
In addition to their DEA compliance programs, registrants must maintain other forms of compliance documentation as well. To survive DEA scrutiny, registrants must document their compliance efforts on an ongoing basis—from their employee training programs to their targeted efforts to meet their obligations under the CSA, DSCSA, and other applicable sources of authority. We provide our clients with the systems they need to generate this documentation as a matter of course, store it securely, and make it available to the DEA when warranted.
DEA Compliance Monitoring, Auditing, and Enforcement
How can you be sure that your company’s personnel are maintaining DEA compliance on an ongoing basis? How can you uncover compliance failures before they lead to DEA scrutiny? How should your company or practice handle employees who make mistakes that have the potential to trigger DEA enforcement action? The answers to these questions lie in effective DEA compliance monitoring, auditing, and enforcement.
While establishing and implementing a DEA compliance program is essential, it is ultimately just the start of an ongoing process. Registrants must take proactive steps to ensure that they remain compliant, and they must address any compliance failures promptly. By giving our clients the tools they need to monitor their compliance efforts, conducting compliance audits, and consulting with our clients regarding employee discipline and related matters, we help them manage their DEA compliance obligations with confidence.
DEA Audits and Inspections
DEA audits and inspections can present risks for the unwary. We help our clients prepare for DEA audits and inspections during the registration and renewal processes and in other scenarios. As former DEA Special Agents, our consultants are intimately familiar with the DEA’s audit and inspection procedures, and we rely on this expertise to help our clients avoid unnecessary issues.
DEA Investigations
Our consultants are also well versed in all aspects of DEA investigations—having played a significant role in these investigations from both sides. While we help our clients mitigate their risk of facing DEA investigations, we also know that the DEA agents will not hesitate to launch an investigation if they have reason (or believe they have) reason to do so. With this in mind, our DEA compliance consulting services also include helping our clients set up DEA investigation response protocols, and we consult with our clients during DEA investigations as well.
FAQs: Establishing and Maintaining DEA Compliance
What does it take to establish DEA compliance?
Drug manufacturers, pharmacies, healthcare providers, and other entities have differing obligations regarding DEA compliance. Broadly speaking, establishing DEA compliance requires the development and implementation of a custom compliance program, as well as ongoing compliance monitoring, auditing, and enforcement.
Do I need to engage a DEA compliance consulting firm?
Most companies and practices will need to engage a DEA compliance consulting firm to help them meet their obligations. There are numerous aspects to DEA compliance, and overlooking even a single aspect can lead to undesired scrutiny (and penalties). A team of experienced DEA compliance consultants will be able to help your company or practice comprehensively meet its obligations on an ongoing basis.
What are the risks of DEA noncompliance?
Failure to comply with the CSA, DSCSA, and the other laws and regulations falling under the DEA’s enforcement jurisdiction can result in administrative, civil, or criminal penalties. These penalties can range from suspension or revocation of DEA registration to fines and federal imprisonment.
How do I prepare for a DEA registration audit or inspection?
Preparing for a DEA registration audit or inspection requires a comprehensive understanding of the issues that can lead to a denial, suspension, or revocation. With this understanding, registrants and applicants can then assess their compliance efforts and determine what preparatory measures are necessary.
What should I do if the DEA is investigating my company or practice?
If the DEA is investigating your company or practice, you should engage a DEA compliance consulting firm immediately. DEA investigations can have substantial negative repercussions, and targeted entities must do everything they can to protect their interests to the fullest extent possible.
Speak with a Former DEA Special Agent about Compliance Today
To speak with one of our former DEA Special Agents about your company’s or practice’s compliance needs, please contact us to arrange a complimentary consultation. Call 866-352-9324 or send us a message online to schedule an appointment today.