Knowledge – Experience –Integrity
DEA Regulatory Matters
The attorneys at Nicholson & Eastin, LLP regularly assist physicians, pharmacists and health care facilities with compliance reviews, administrative audits and investigations relating to the federal and state laws regulating the storage, prescribing and dispensing of controlled substances.
According to the DEA, combating the diversion of controlled substances is a top priority of the agency. Consistent with this statement, DEA has significantly stepped up its enforcement efforts against controlled substance distributors, prescribers and pharmacies, bringing administrative, civil and criminal actions against registrants. These actions can include the denial of a registration application, the revocation of a registration, civil penalties and criminal prosecution.
DEA tracks the ordering and dispensing of controlled substances through it ARCOS database, through onsite inspections of pharmacies and offices of dispensing physicians, and through suspicious order reports from distributors. Pursuant to federal regulations, DEA has the authority to conduct onsite inspections of registered locations - distributor warehouses, pharmacies and dispensing physicians' offices. DEA is authorized to inspect ordering records (DEA Forms 222), inventory control records, prescriptions and related documents. DEA can also inspect for proper physical security measures. DEA usually conducts these inspections pursuant to a notice of inspection, but if it suspects that a registrant may be uncooperative, the DEA can obtain an administrative warrant to compel an immediate inspection. In the case of a criminal investigation, DEA can also utilize a criminal search warrant, but DEA often utilizes its administrative inspection authority to gather evidence in support of a criminal investigation.
If DEA concludes that a registrant has violated the Controlled Substances Act, DEA can initiate a suspension or revocation of a practitioner’s registration. Often, however, DEA will seek a “voluntary relinquishment” of a registration from the practitioner before initiating formal administrative suspension or revocation proceedings. This is typically done during an unannounced visit and without the practitioner having the benefit of counsel.
It is rarely in the best interest of the practitioner to voluntarily relinquish their DEA registration, and once executed, it can be extremely difficult to secure a new registration. Agents have been known to advise practitioners that they can apply to renew their DEA registration at a later point in time. However, obtaining a new DEA registration number after it is relinquished is extremely difficult since DEA considers it virtually the same as a revocation.
If DEA initiates formal action against a registration, the practitioner will receive either a notice of emergency suspension or a show cause order directing the practitioner to “show cause” why their registration should not be revoked. DEA show cause hearings are held before administrative law judges who decide if it is in the public’s interest to maintain or revoke a practitioner’s registration. Show cause hearings are essentially non-jury trials.
Voluntary relinquishments, suspensions and revocations of DEA registrations are reported to the National Practitioner Data Base, and are also often reported to state professional practice licensing authorities. As a result, DEA enforcement actions can have serious collateral consequences for practitioners, including professional licensure action, Medicare and Medicaid provider revocation or exclusion, loss of facility credentialing, and loss of private insurance credentialing.
More recently, DEA has formed "tactical diversion squads," consisting of DEA Diversion Investigators and DEA Special Agents, to conduct criminal investigations of registrants. Diversion Investigators are not authorized to carry weapons or to make arrests, whereas Special Agents are authorized to do both. Registrants who are subjected to DEA inspections should request the business cards of all the government personnel who are present during an inspection. The presence of a Special Agent does not necessarily mean the registrant is under criminal investigation, but it may be an indicator.
Similarly, in the last several years Florida state authorities have significantly increased their oversight of the prescribing and dispensing of controlled substances by medical professionals. Often working in conjunction with the DEA, the Department of Health will conduct inspections of dispensing premises to ensure that the dispensing practitioner is complying the state and federal regulations regarding recordkeeping, inventory protection and control and licensing requirements. Additionally, Department of Health inspectors will assess whether the quantity and combination of controlled substances are consistent with proper use and treatment with controlled substances. If the Department of Health believes that the practitioner may have violated a provision of their respective practice act, they will refer the matter for initiation of an investigation of the practitioner and possible licensure action. The licensure sanctions can range from a citation or letter of concern on the low end, to revocation of license and significant fines on the high end.
Recent changes to Florida law have imposed strict new requirements for prescribers of controlled substances, restricting the dispensing of controlled substances by prescribers, and require specific documentation elements and initial and periodic in-person encounters with patients who receive prescriptions for controlled substances, particularly for those that receive controlled substances for chronic non-malignant pain. Prescribers need to become familiar with these requirements, particularly those that can be deemed under the laws to operate a "pain clinic" or prescribe for the treatment of chronic non-malignant pain. The current wording of the statute is ambiguous in some respects regarding who qualifies as a "pain clinic," and prescribers should consult with counsel if there is any question in their mind as to whether they qualify.
Finally, a number of cities have enacted ordinances directed at "pain clinics," and these ordinances do not necessarily utilize the same definitions and criteria as state law, and local authorities are often not familiar with practice of medicine protocols and requirements, and can overstep in their efforts to enact and enforce their local ordinances.
Whether contacted by DEA, local law enforcement authorities, or the Florida Department of Health, health practitioners and facilities need to be aware that Federal and state laws carry significant administrative, civil and criminal penalties for violations of controlled substance laws. Any contact by these agencies, other than the most routine contacts, should be taken very seriously.