What Causes DEA Opioid Investigations.

DEA opioid investigations do not begin with suspicion. They begin with data.

The contemporary DEA investigation of a prescriber, pharmacist, or healthcare entity is initiated by information that exists in databases before any investigator develops a theory about any specific practitioner. Prescription drug monitoring programs record every controlled substance prescription dispensed in real time. The DEA's Automation of Reports and Consolidated Orders System tracks every purchase of controlled substances by every DEA registrant in the country. Analytics systems applied to that data identify statistical outliers: practitioners whose prescribing volume, drug combinations, patient geographic distribution, or cash payment rates are anomalous relative to their peers. The investigation that follows the data anomaly is the investigation that results in the practitioner first becoming aware of government attention.

Prescription Drug Monitoring Program Referrals

State PDMPs are the most prolific source of investigative referrals in the current enforcement environment. Every state now operates a PDMP, and most states require prescribers to consult the PDMP before issuing controlled substance prescriptions and pharmacists to consult it before filling them. The PDMP data reveals patterns that individual prescribers and pharmacists cannot see in isolation: the patient who visited seventeen different prescribers in the past ninety days, the prescriber whose patient population has a disproportionate rate of controlled substance prescriptions relative to any comparable practice, and the pharmacy that fills prescriptions from a specific prescriber at rates that dwarf its filling of comparable prescriptions from other practitioners.

PDMP data is shared with the DEA's Diversion Control Division in most states. Referrals from PDMP administrators to the DEA are a routine component of the data-sharing arrangement that state legislatures and regulatory agencies have authorized as part of opioid enforcement programs. A practitioner who appears as a statistical outlier in the PDMP data may have generated a DEA referral without any individual complaint having been filed.

Patient Complaints and Whistleblowers

Individual complaints from patients, former employees, competing practitioners, and pharmacists who declined to fill prescriptions are a significant source of DEA investigative referrals. A former office manager who observed prescriptions being issued without patient examinations, a pharmacist who became uncomfortable filling a particular practitioner's prescriptions and reported their concerns to the DEA, or a patient's family member who believes a prescription contributed to their relative's overdose death may each initiate an investigation that would not otherwise have begun.

Whistleblower complaints in the healthcare context are particularly significant because the False Claims Act's qui tam provisions permit private individuals to file sealed complaints on the government's behalf and to share in any civil recovery. A former employee who files a qui tam complaint alleging that a practitioner's opioid prescribing was billed to Medicare or Medicaid as medically necessary when it was not has initiated both a civil enforcement proceeding and, frequently, a referral to the DEA's criminal enforcement division.

Overdose Death Investigations

When a patient dies of an opioid overdose, the investigation of the death may generate a referral to the DEA if the decedent held one or more controlled substance prescriptions from a specific practitioner. Medical examiners who certify opioid overdose deaths are required in most jurisdictions to report the prescribers whose controlled substances appeared in the toxicology findings to the state medical board and to state law enforcement. Those reports create investigative referrals that the DEA receives through its coordination with state agencies.

The prescriber who loses a patient to overdose is a prescriber who may find themselves the subject of a DEA investigation without any deliberate act of diversion having occurred. The patient who died may have been legitimately prescribed the medication that contributed to their death, and the prescriber's clinical judgment in issuing the prescription may have been defensible. The investigation nonetheless follows the death, and the prescriber who responds to it without counsel is responding without an adequate understanding of where the investigation may lead.

DEA Data Analytics Programs

The DEA operates sophisticated data analytics programs that monitor controlled substance prescribing and dispensing patterns without waiting for a complaint or a referral. The Tactical Diversion Squad program concentrates investigative resources in geographic areas with high rates of controlled substance diversion. The ARCOS system tracks every order of controlled substances placed by every DEA registrant and identifies purchasing patterns inconsistent with legitimate dispensing needs.

An investigation that begins in a database does not feel like an investigation until the diversion investigator appears at the door. By that point, the data analysis has been completed, the patterns have been identified, and the investigation has a theory. The practitioner who prepared for that visit would have done so months earlier, when the prescribing patterns that generated the data flag were still occurring. Preparation after the visit is damage management. Preparation before it is something else.

DEA Coordination With State Agencies

The DEA coordinates with state medical licensing boards, state pharmacy boards, and state law enforcement in a manner that means a single investigation may produce parallel state and federal proceedings. A referral from a state medical board to the DEA, or from the DEA to a state board, can initiate proceedings in each forum that proceed simultaneously. The administrative action by the state board to suspend or revoke a medical license, the administrative action by the DEA to suspend or revoke the DEA registration, and the criminal investigation may all be underway simultaneously, each producing its own demands on the practitioner's time, records, and legal resources.

The practitioner who retains a single attorney experienced in DEA administrative proceedings without also retaining counsel who can address the criminal investigation and the state board proceedings has retained counsel for one front of a multi-front engagement. The full scope of the exposure requires the full scope of the representation.