- DEA compliance experts offer the experience and knowledge to prepare hospitals, pharmacies, and physician groups for audits and DEA subpoenas.
- Working with experienced DEA compliance consultants sends a strong signal of compliance to auditors and DEA diversion investigators.
- Consider adding instant credibility to your practice by searching for a “former DEA Supervisory Special Agent” or a “retired DEA Diversion Investigator”.
What do hospitals, pharmacies, pharmaceutical manufacturers, and physicians all have in common? As DEA-registrants, they must make sure that they comply with the rigid requirements of state and federal law compliance. Each year, the DEA conducts thousands of unannounced administrative audits and issues thousands of medical records subpoenas in an effort to monitor and enforce compliance under the Controlled Substances Act (CSA). To be prepared for these audits and to pass them in case your business is targeted, DEA registrants are well-advised to utilize the experience and knowledge of DEA compliance experts.
How Can a DEA Compliance Expert Protect Your Business?
The Drug Enforcement Administration (DEA) is tasked to enforce federal laws and DEA regulations under the Controlled Substances Act and other statutes. In recent years, the DEA in combination with the FBI, the Office of Inspector General (OIG), the U.S. Department of Health and Human Services, U.S. Attorney’s Offices across the nation, and the U.S. Department of Justice have significantly increased civil and criminal prosecutions against prescribing physicians, PICs, pharmacies, distributors, sales representations, wholesalers, veterinarians, hospitals, and other DEA-registrants.
In this climate of heightened enforcement and regulatory scrutiny, every DEA license holder, be it individual or institutional, may want to weigh the risk of being non-compliant—and risking significant penalties or even criminal arrests—or simply investing a small amount of time and resources to get expert assurance that you are truly doing everything right when it comes to DEA compliance.
The role of a DEA compliance expert in this context is simple. While it is fairly ineffective for students to grade their own papers, it is also imprudent for hospitals and pharmacies and doctors to self-audit their regulatory compliance. For one, no doctor and no pharmacy owner is trained to actually know what constitutes compliance and where the line to unlawful conduct begins. For another, in addition to lacking expertise, even if you attempt to conduct an internal analysis of your regulatory compliance, your credibility may be called into question due to a perception of bias.
· Handling of Subpoenas or Pending Audit
· Defense against DEA Diversion Investigation
· Regulatory Compliance Audit
· Employment Security
· Training & Education
· Mock- DEA Inspections
· Report of Findings
The better, the more effective, the proven way to ensure DEA registration compliance and DEA operational compliance is to work with an expert in the field who can, while serving your interests, advise you objectively and reliably how to best meet expected government expectations. Should your business or your practice then ever do become subject to an audit, you will have the confidence of operational and regulatory compliance—as established by an expert well-respected (perhaps even known) by the inspecting DEA agents or PMB auditors.
What Kind of Expertise Can You Expect from a DEA Consultant?
Depending on your concrete needs and whether you are reaching out to a consultant proactively and preventively or prompted by an already ongoing audit, the job of a DEA consultant is to review, analyze, and boost both your regulatory and your operational compliance.
Regulatory Compliance. The healthcare industry is one of the most regulated industries in the United States. Covered by many layers of rules and regulations, state and federal laws, anyone operating in or billing for healthcare services must, as a legal requirement in itself, demonstrate familiarity with all applicable rules. The job of an DEA advisor thus is to cover your basics when it comes to the five major laws: False Claims Act (don’t submit claims to insurance companies or federal payors that are incorrect or false), the Anti-Kickback Stature (don’t engage into a referral relationship with physicians where even one purpose is to send or receive referrals based on anything of value—particularly problematic are medical consulting agreements, medical directorships), Stark Law (physicians are generally speaking not allowed to have a financial interest in an entity to which they refer business), HIPAA (protecting every patient’s privacy and secrecy of information), and the Controlled Substances Act (which contains civil and criminal penalties for violations such as scripts lacking medical necessity).
Operational Compliance. A key element of every self-audit is to see how the more abstract regulatory framework is applied in practice. It is one thing to be familiar with the Controlled Substances Act; but it may be a different thing to tailor your operations in such a way that laws are followed on a day-to-day basis. Experienced pharmacy consultants will thus be instantly familiar with mitigating risks, inventory reviews, PDMA compliance, system validation, SOP reviews, quota calculations, hospital due diligence, pharmacy due diligence, pharmaceutical supply chain issues, diversion prevention, and compliance with state board of pharmacy rules. One starting point typically is to ensure that the existence and accuracy of your opioid handbooks and protocols, which, if missing, can be provided by DEA experts as tailored to your particular needs.
DEA Diversion Prevention
At the end of the day, all efforts whether on a voluntary basis or because prompted by a crisis situation are focused on one goal: diversion prevention. Indeed, diversion of controlled substances has been one of the most dominant topics in healthcare and DOJ enforcement over the past years, with no end in sight. Whether you read about pill mills, take-downs of doctors, search warrants, raids, arrests, or revocations of DEA licenses, all these events were based on the DEA’s position that the DEA registrant in question contributed to a diversion of narcotics.
Sophisticated DEA consultants will know how to assess your risk and how to lead you through crisis management. There are many so-called experts offering their services in the marketplace. Caution is in order. You want to affiliate yourself with someone who not just has the objective background and expertise, but who also imports the credentials needed to convince DEA diversion investigators and federal law enforcement agents that your facility and your practice are indeed compliant. Before you engage anyone, consider asking the following questions to get a feel for the person’s experience. The more specific your questions, the higher your expectation should be to obtain a specific answer.
- What exactly is your experience with the DEA?
- What is your experience with the Controlled Substance Act?
- Do you have expertise advising on DEA compliance questions?
- Have you worked DEA diversion cases before?
- What documents and protocols can you offer?
- Are your policies and protocols templates or tailored to a particular client?
- Can you create DEA compliance checklists?
- Will your services help us long-term?
- Do you have experience with 21 U.S.C. 841?
- We are under a DEA audit: do you know what to do?
- We just received a DEA subpoena: can you help us keep our license?
- We are afraid of an investigation: can you tell us how to best avoid penalties?
One way to capture DEA experience, law enforcement experience, experience with investigation, experience with audits, experience with the Controlled Substances Act, experience with subpoenas, and offering instant credibility to your business is to search for a former DEA official such as a “former DEA Supervisory Special Agent” or a “retired DEA Diversion Investigator”.