What Are Potential Outcomes if My Practice Is Under Investigation for Opioid Fraud
The range of outcomes in a DEA opioid investigation extends from full exoneration with no adverse consequence to lengthy federal imprisonment. Where a specific matter falls within that range depends on the evidence, the conduct, the investigative stage at which counsel engages the matter, and the specific legal strategy pursued.
The practitioner who understands the full range of possible outcomes at the beginning of a DEA investigation is better positioned to make informed decisions about how to respond than the practitioner who assumes either that the investigation will produce no adverse result or that adverse results are inevitable. Both assumptions lead to strategic errors. The full range of outcomes, and the factors that influence which outcome a specific matter produces, is the starting point for the strategy.
No Action or Declination
The government declines to take action in a portion of the cases it investigates. A declination may occur because the investigation developed insufficient evidence to support a charge or an administrative proceeding, because the conduct identified did not meet the legal standard for the applicable offense, or because the prosecutorial office determined that the case did not warrant the resources required for prosecution relative to other priorities.
Pre-indictment intervention by experienced counsel can increase the probability of a declination by presenting the government with information that challenges its theory, demonstrating that the prescribing was based on legitimate clinical judgment supported by adequate documentation, and persuading the prosecuting office that the case is weaker than the investigation’s data-driven beginning suggested. The declination that results from effective pre-indictment advocacy is an outcome that is available only to practitioners who retained counsel early enough to engage the government before its charging decision was made.
Administrative Consequences
The DEA may pursue administrative action against a practitioner’s DEA registration independent of any criminal prosecution. An administrative proceeding before a DEA administrative law judge may result in the revocation of the practitioner’s DEA registration, a suspension of the registration for a specified period, or a consent agreement under which the practitioner agrees to specific conditions on their prescribing practice in exchange for the resolution of the administrative proceeding without revocation.
The state medical licensing board may initiate separate proceedings to impose conditions on, suspend, or revoke the practitioner’s medical license. State board proceedings and DEA administrative proceedings can occur simultaneously, and an adverse outcome in one proceeding may affect the practitioner’s position in the other. The practitioner who loses their DEA registration while retaining their medical license can practice medicine in areas not requiring controlled substance prescribing. The practitioner who loses their medical license loses the authorization to practice medicine regardless of the status of their DEA registration.
Exclusion from participation in Medicare and Medicaid, imposed by the OIG, is a third administrative consequence that may arise from the same conduct that generated the DEA investigation. Exclusion is a civil administrative sanction that eliminates the practitioner’s ability to bill federal healthcare programs and effectively ends any practice that depends on Medicare and Medicaid reimbursement. Exclusion proceedings may accompany or follow criminal proceedings and are not barred by a criminal acquittal.
Civil Monetary Penalties and False Claims Act Liability
The OIG may impose civil monetary penalties on practitioners whose claims to Medicare or Medicaid were false or fraudulent. The penalties are assessed per false claim and are imposed in addition to any repayment of the falsely billed amounts. False Claims Act liability adds treble damages on top of the civil penalty structure, and the combined exposure in a high-volume prescribing practice with significant Medicare or Medicaid billing can reach amounts that are financially devastating independent of any criminal consequence.
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(212) 300-5196Civil monetary penalties and False Claims Act liability may be resolved through negotiated settlements with the OIG and the DOJ before litigation is initiated. The settlement process involves the production of evidence, negotiations over the amount of liability, and in some cases the negotiation of a corporate integrity agreement that imposes ongoing compliance obligations on the practitioner as a condition of continued Medicare and Medicaid participation.
Criminal Prosecution
The most severe outcome of a DEA opioid investigation is criminal prosecution under 21 U.S.C. 841 for distribution of controlled substances outside the usual course of professional practice, or under the wire fraud, mail fraud, or healthcare fraud statutes for billing-related conduct. The mandatory minimum sentences applicable to drug distribution charges can produce incarceration terms that are measured in decades, particularly where the quantity of controlled substances attributed to the defendant through the relevant conduct calculation is substantial.
Criminal prosecution may be preceded by civil settlement, may proceed simultaneously with civil proceedings, or may follow the resolution of administrative proceedings. The government’s decision about the sequence of proceedings in a given case reflects its assessment of the most effective enforcement strategy. The practitioner who resolves civil proceedings before criminal charges are filed has not foreclosed criminal prosecution, and the statements and records produced in civil proceedings may be used in the criminal case.
The outcome of a DEA opioid investigation is not determined solely by what the practitioner did in the past. It is also determined by what happens from the moment the investigation becomes known. The practitioner who retains experienced counsel, who engages the investigation strategically, who cooperates with legitimate government requests while protecting their legal rights, and who addresses compliance issues proactively occupies a different position in the range of outcomes than the practitioner who does not. That difference is not guaranteed, and the facts of the underlying conduct constrain the range significantly. But within the range that the facts permit, the quality of the legal response is the variable that most reliably affects the outcome.
Todd Spodek
Lead Attorney & Founder
Featured on Netflix's "Inventing Anna," Todd Spodek brings decades of high-stakes criminal defense experience. His aggressive approach has secured dismissals and acquittals in cases others deemed unwinnable.
Managing Multiple Simultaneous Proceedings
The practitioner who is the subject of a DEA criminal investigation, an OIG civil investigation, a state medical board proceeding, and a carrier audit simultaneously is managing four proceedings that share a factual foundation but that are governed by different legal standards, administered by different agencies, and subject to different procedural rules. The decisions made in one proceeding affect the practitioner’s position in the others, and the coordination of the response to all four requires counsel who understands each proceeding and who can develop a strategy that addresses all of them in an integrated manner.
The integrated defense of multiple simultaneous proceedings is among the most demanding challenges in healthcare law. It requires counsel who is experienced in criminal defense, administrative law, civil healthcare fraud, and state licensing proceedings, either through a single practitioner or through a team of specialists who communicate and coordinate their work.
The consultation that maps the full scope of exposure across all pending and potential proceedings, that identifies the legal standards applicable to each, and that develops a coordinated strategy for addressing all of them is the consultation that gives the practitioner the most complete understanding of their situation and the most comprehensive framework for managing it. That consultation is available before the investigation has matured into formal proceedings in every forum, and the earlier it occurs, the more of the range of favorable outcomes remains accessible.
