How Can I Demonstrate that I Don’t Have Any Criminal Intent

Criminal intent in an opioid fraud prosecution is demonstrated through the presence or absence of documentation that reflects genuine clinical judgment at the time the prescription was issued. The documentation created contemporaneously is the most reliable evidence of what the practitioner was thinking when they prescribed.

The Supreme Court’s decision in Ruan v. United States in 2022 established that the government must prove beyond a reasonable doubt that the defendant subjectively knew they were acting outside the usual course of professional practice or without a legitimate medical purpose. The good faith defense, the argument that the practitioner genuinely believed the prescriptions were medically appropriate, is the primary vehicle for demonstrating the absence of criminal intent. That defense is built from the documentary record that predates the investigation.

The Documentation of Clinical Judgment

A practitioner who documents their clinical reasoning for each controlled substance prescription, who records the physical examination findings that supported the prescription decision, and who notes the clinical factors that distinguished the specific patient’s need from a patient the practitioner would not have prescribed to has created contemporaneous evidence of their state of mind at the time of prescribing. That documentation is the most powerful evidence of good faith available in the context of a criminal prosecution.

The documentation does not need to be elaborate. It needs to be specific, contemporaneous, and clinically meaningful. A note that records the patient’s pain level and functional impairment, the relevant examination findings, the patient’s current medication list, the PDMP check result, and the clinical rationale for the specific medication and dose prescribed tells a story about a practitioner exercising professional judgment. A note that records only the diagnosis code and the prescription without any supporting clinical content does not.

Use of Clinical Guidelines

Demonstrating compliance with applicable clinical guidelines is evidence of good faith even where the prescribing deviated from those guidelines in specific cases. The practitioner who can show that they were aware of the CDC’s opioid prescribing guidelines, the specialty society’s pain management standards, and the state medical board’s prescribing expectations, and who documented the clinical reasons for departures from those guidelines in specific cases, has demonstrated the engagement with professional standards that characterizes legitimate clinical practice.

Documentation of referrals to pain management specialists, requests for consultation on complex cases, participation in continuing medical education on pain management and opioid prescribing, and the use of evidence-based assessment tools for opioid risk are each forms of evidence that support the good faith defense. They demonstrate that the practitioner was not indifferent to the clinical and regulatory framework governing their prescribing.

Risk Assessment and Patient Monitoring

A practitioner who used validated opioid risk assessment tools before initiating opioid therapy, who implemented urine drug screening to monitor patient compliance with prescribed medications, who conducted pill counts on patients at higher risk of diversion, and who documented these monitoring activities in the patient record has created evidence of the clinical oversight that distinguishes legitimate pain management from prescription distribution.

The patient who diverted their prescriptions despite the practitioner’s monitoring efforts is a patient whose diversion reflects the patient’s conduct, not the practitioner’s indifference to it. The practitioner whose record shows no awareness of and no response to the risk of diversion, and whose patients present as frequent flyers in multiple pharmacy PDMP records, has created a record that supports the inference that the practitioner was not exercising clinical judgment but was processing transactions.

The Treatment Agreement and Its Role

Controlled substance treatment agreements, also called pain contracts, are written documents signed by the patient at the initiation of opioid therapy that establish the conditions of the prescribing relationship. They specify the patient’s obligations, including compliance with the prescribed regimen, prohibition on obtaining controlled substances from other providers, and submission to urine drug screening. They document the patient’s informed consent to the risks of opioid therapy and the consequences of non-compliance.

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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.

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A practitioner who used treatment agreements consistently, who enforced them by discontinuing prescribing for patients who violated their terms, and who documented both the agreement and the monitoring of compliance with it has created evidence of a prescribing practice that operated within a framework of clinical accountability. The presence of treatment agreements in every patient file does not guarantee the prescription’s legitimacy, but it is evidence of professional structure that an illegitimate prescribing operation would not have maintained.

Good faith is demonstrated most powerfully by the records that were created before any investigation was contemplated. The treatment plan written on the day of the patient’s first visit, the PDMP check documented in the encounter note, the risk assessment score recorded in the initial evaluation, and the monitoring note that reflects a conversation about medication compliance are records that no investigator can characterize as manufactured for the defense. They were made when the only audience was the patient and the standard of care. That is when they do their most important work.

The Expert Who Can Explain It

Even the most thorough documentation is only as useful as the expert who can explain its clinical significance to an investigator, a grand jury, or a trial jury. Retaining a medical expert who can review the clinical record and articulate why the documentation reflects legitimate medical judgment, why the prescribing was within the range of acceptable clinical practice given the specific patient population, and why the absence of diversion intent is demonstrated by the clinical approach is the component that translates documentation into a coherent defense narrative. Documentation without expert interpretation is raw material. Documentation with expert explanation is a defense.