The government does not make clinical determinations. It makes statistical ones, and then it retains a physician expert to translate those statistics into clinical conclusions.
This distinction is important and is consistently misunderstood by practitioners who assume that the DEA’s investigative process involves a physician reviewing their patients’ cases and reaching clinical judgments about each prescription. It does not, at least not in the investigation’s early stages. The investigation begins with data, and the data produces a theory of the case that the government’s medical expert is then retained to support.
The PDMP Statistical Analysis
The primary tool through which the government assesses medical necessity in opioid prescribing cases is the prescription drug monitoring program data. The PDMP records every controlled substance prescription dispensed in the state, including the drug, the dose, the quantity, the prescriber, the patient, and the pharmacy. The DEA’s analytical systems apply statistical analysis to this data to identify prescribers whose patterns deviate from the norms of their specialty, their geography, and their patient population.
The statistical outlier analysis identifies prescribers who prescribed opioids at higher volumes, in higher doses, to more patients, or in combinations more frequently associated with diversion than the comparison population. The analysis is peer-based: it compares the target prescriber against practitioners in the same specialty, the same geographic region, and the same billing category. A pain management specialist who prescribes at the ninety-ninth percentile of their specialty peers in opioid prescribing volume is an outlier relative to those peers, and that outlier status is the threshold finding that the investigation uses to support the theory of prescribing outside the usual course of professional practice.
The Government’s Medical Expert
After the statistical analysis has identified the target prescriber as an outlier, the government retains a physician expert, typically a board-certified pain management specialist or addiction medicine physician, to review a sample of the prescribing records and render an opinion about whether the prescriptions were issued within the usual course of professional practice and for a legitimate medical purpose.
The government’s expert review typically selects a sample of patient files, often those whose prescribing patterns are most anomalous, and assesses whether the medical records adequately document the clinical basis for the prescriptions. Where the records are sparse, where examination findings are absent or inadequate, where the same diagnosis appears in identical language across multiple patients, or where the prescribed doses and combinations are inconsistent with any recognized treatment protocol, the expert opines that the prescriptions were not medically necessary and were issued outside the usual course of professional practice.
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(212) 300-5196This expert opinion is the pivot point in the government’s case. The statistical analysis establishes the anomaly. The expert opinion translates the anomaly into a clinical conclusion. The defense must challenge both: the statistical methodology that produced the comparison and the clinical judgments that the government’s expert rendered about specific prescriptions.
Challenging the Medical Necessity Determination
The defense challenges the government’s medical necessity determination at two levels. First, the statistical methodology: the peer comparison that identified the practitioner as an outlier may have used an inappropriate peer group, failed to account for the specific characteristics of the patient population, or applied a comparison metric that does not reflect the clinical reality of the practice. A rural primary care physician who is the sole provider for a population with high rates of occupational injury and chronic pain conditions should not be compared against urban primary care physicians serving demographically different populations.
Second, the clinical expert opinion: the government’s expert reviewed a selected sample of cases, often the most anomalous ones, and reached conclusions based on the documentation present in those files. The defense expert reviews the same files, may review additional files not selected by the government, and provides an alternative clinical opinion that explains why the prescriptions were medically appropriate given the patient’s specific condition, history, and circumstances. The competing expert opinions are the core of the medical necessity contest at trial.
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.
The government’s determination that a prescription was not medically necessary is an opinion, not a fact. It is an opinion formed by a physician retained by the government, reviewing records selected by the government, applying standards the government’s theory requires. It is an opinion that can be challenged, rebutted, and in many cases discredited by a defense expert who has reviewed the same records and reached a different clinical conclusion. The medical necessity determination is not the end of the analysis. It is the beginning of the contest.
You learn that federal investigators want to interview you about a business transaction you were involved in.
Should you agree to speak with them?
Never agree to a federal interview without an attorney present. Under 18 U.S.C. 1001, any false statement to a federal agent is a felony. An experienced defense attorney can advise you on your rights and ensure you do not inadvertently incriminate yourself.
This is general information only. Contact us for advice specific to your situation.
The Role of Clinical Guidelines
The government’s expert will typically reference applicable clinical guidelines, including the CDC’s opioid prescribing guidelines, specialty society guidelines for pain management, and state medical board guidelines, as the framework against which the prescribing is measured. The defense must address those guidelines directly: whether the practitioner was aware of them, whether the prescribing reflected them, and whether the specific patient circumstances justified a departure from the guidelines’ general recommendations.
Clinical guidelines are not the legal standard for medical necessity. They are evidence of the standard of care that both parties use to support their respective expert opinions. The defense that demonstrates familiarity with the applicable guidelines, documents the clinical reasons for departures from them in specific cases, and presents a medical expert who can explain those reasons to a jury is the defense that most credibly contests the government’s medical necessity determination.
