What Type of Doctor-Patient Relationship Is Expected When a Patient Receives Controlled Substances Prescriptions?
The Relationship the Statute Requires but Does Not Define
The federal standard for prescribing controlled substances rests upon a relationship the regulation assumes and the enforcement apparatus interrogates. 21 C.F.R. 1306.04(a) provides that a prescription for a controlled substance is valid only if issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. The regulation does not define the term “legitimate medical purpose.” It does not specify what constitutes the “usual course of professional practice.” It does not describe the relationship between prescriber and patient that must exist before a prescription becomes, in the government’s estimation, something other than a piece of paper with a DEA number on it.
The absence of a statutory definition has not prevented the government from constructing one. The definition emerges in prosecution, in administrative revocation proceedings, in the testimony of government experts who review patient charts and determine, after the clinical encounter has concluded, whether what occurred in the examination room satisfied a standard the prescriber was never provided in writing. The definition is, if one traces its contours through the case law, an amalgamation of state medical board regulations, CDC prescribing guidelines the CDC itself has characterized as voluntary, and the professional judgment of retained experts whose opinions carry the authority of credentials applied in the absence of clinical context.
The Examination as Predicate
Thirty-six states and the District of Columbia impose physical examination requirements upon prescribers of controlled substances. The requirements vary. Virginia mandates that the prescriber obtain a medical history, perform an appropriate examination, provide information concerning risks, and initiate follow-up care. Alabama permits exceptions for telemedicine, for on-call prescribing, and for short-term continuation of existing medications before an initial appointment. Florida imposes supply limitations that are duration-specific. Tennessee requires documentation thresholds calibrated to prescription length. The practitioner operating across state lines inhabits a regulatory architecture in which the obligations shift with geography, and the federal standard, which supplies no examination requirement of its own, sits above these state mandates with the silence of a framework that has delegated its specificity to fifty-three jurisdictions.
What the DEA searches for, when it reviews patient charts in the course of an investigation, is evidence that a clinical relationship preceded the prescription. The agency does not publish a checklist. We have addressed the agency’s investigative methodology in prior articles concerning chart review and the role of the government’s expert witness. The relevant point here is narrower: the agency evaluates the relationship by examining the documentary residue the relationship produced, and the documentary residue the agency considers sufficient is a record that reflects, at minimum, a physical or telehealth examination, a diagnosis, a treatment plan, evidence that the Prescription Drug Monitoring Program was consulted, and notation that the prescriber assessed the patient’s risk for substance misuse before placing the DEA number on the prescription pad.
The physician who performed all of these acts but recorded only some of them has created a record the government’s expert can characterize as deficient. The physician who recorded all of them has created a record the government’s expert will examine for internal consistency.
The Ryan Haight Act and the Question of Physical Presence
Congress enacted the Ryan Haight Online Pharmacy Consumer Protection Act in 2008 following the death of a teenager who obtained hydrocodone through an internet pharmacy without ever seeing a physician. The statute amended the Controlled Substances Act to require that, where a controlled substance is prescribed by means of the internet, the prescribing practitioner must have conducted at least one in-person medical evaluation of the patient. The requirement was categorical. The exceptions were narrow: a patient located in a hospital or clinic registered with the DEA, a patient in the physical presence of a practitioner registered with the DEA, and several other circumstances that did not contemplate the model of telehealth in which both patient and provider participate from separate locations.
The COVID-19 public health emergency suspended the in-person requirement. The DEA extended that suspension, then extended it again, then again, and on December 30, 2025, published a fourth temporary extension through December 31, 2026, permitting practitioners to continue prescribing Schedule II through V controlled substances via telemedicine without a prior in-person evaluation. In January 2025, the DEA proposed a Special Registration for Telemedicine that would, if finalized, establish a permanent framework under which practitioners could prescribe Schedule III through V substances without an in-person visit, and Schedule II substances under more restricted conditions requiring board certification in specified specialties. The proposed rule would also, for the first time, require online platforms that connect patients with prescribers to register with the DEA.
The rule has not been finalized.
The practitioner prescribing controlled substances via telemedicine in 2026 operates under a temporary extension of emergency flexibilities that the agency has declined to make permanent, which means the regulatory foundation beneath the prescriber’s practice is, at this writing, a series of provisional authorizations whose continuation depends upon administrative decisions the prescriber cannot predict and the agency has not committed to in any document that would survive notice-and-comment scrutiny, a condition that produces in the conscientious prescriber a particular species of uncertainty that no compliance program, however thorough, can eliminate because the rules themselves have not yet been determined.
What the Agency Considers a Relationship and What It Does Not
The DEA’s enforcement posture toward the doctor-patient relationship is visible in the cases it has brought. In a 2025 Federal Register proceeding, a physician acknowledged issuing nine prescriptions for oxycodone and other controlled substances to patients, including one individual confined in a correctional facility, without conducting a medical examination, without establishing what the agency termed a “bona fide physician-patient relationship,” and without maintaining records. In December 2025, a Spokane physician paid $120,000 to resolve allegations that he prescribed controlled substances without legitimate medical purpose, having issued over 1,400 prescriptions in combinations of opioids, benzodiazepines, sedatives, and carisoprodol to thirteen patients over an eight-year period while failing to address what the government characterized as numerous red flags of substance abuse.
These are the cases the agency selects to announce. They represent the outer boundary of conduct the agency considers prosecutable. The interior of that boundary, where the prescriber maintained records and performed examinations but the government’s expert questions the adequacy of both, is where most investigations reside and where the definition of a sufficient doctor-patient relationship acquires its operational meaning.
The relationship the regulation requires is not a relationship the regulation describes. It is a relationship the government reconstructs from records, measures against a standard it has assembled from sources the prescriber may not have consulted, and evaluates under conditions the clinical encounter did not share.
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The question of whether a doctor-patient relationship existed is, in the enforcement context, a question of whether the documentary evidence permits the government to argue that one did not.
The Subjective Standard and the Relationship It Protects
In June 2022, the Supreme Court held in Ruan v. United States that the government must prove the defendant knew or intended that the prescribing conduct was unauthorized. The decision was unanimous. Justice Breyer, writing for the Court, rejected a standard that would have permitted conviction of a physician whose prescribing was objectively unreasonable even if the physician believed in genuine good faith that the prescriptions served a legitimate medical purpose. The Court required subjective mens rea. The government must demonstrate not that the prescribing departed from the usual course of professional practice, but that the prescriber knew it did.
The holding altered the relationship between the doctor-patient encounter and the criminal prosecution that may follow it (which defenders of the prior objective standard will insist was already adequate, though the conviction rate suggested otherwise). Before Ruan, a physician who maintained a clinical relationship with a patient, who examined the patient, who documented a diagnosis and a treatment rationale, could be convicted if the government’s expert testified that the prescribing fell outside accepted practice. After Ruan, the government must prove the physician understood the prescribing was outside accepted practice and prescribed regardless. The doctor-patient relationship, under this standard, is not merely evidence of clinical appropriateness. It is evidence of subjective intent. A physician who can demonstrate the existence of a genuine clinical relationship, with examinations, follow-up appointments, adjustments to treatment, and documented responses to clinical developments, has constructed a record that makes the government’s burden of proving subjective knowledge of unauthorized conduct measurably more difficult to satisfy.
You treat the patient, you document the treatment, and then you discover whether the documentation was sufficient only when someone in a federal building opens the file.
The Relationship the Enforcement Apparatus Has Contracted
There is a structural observation that belongs here, though it concerns the system rather than the individual practitioner. The number of physicians willing to prescribe opioids for chronic pain has contracted. The contraction is a product of enforcement. Physicians have observed colleagues investigated, sanctioned, prosecuted. The rational response to the observation that prescribing controlled substances in volume generates federal attention is to prescribe fewer controlled substances, or to cease prescribing them, or to exit pain management. The patient population that requires opioid therapy has not contracted in proportion. The patients remain. The prescribers diminish.
In seven of the nine administrative proceedings we reviewed from the past eighteen months in which the DEA sought revocation of a practitioner’s registration, the agency cited the absence of a sufficient doctor-patient relationship as a ground for revocation. The relationship the agency required, described through the lens of what was absent rather than what would have been sufficient, included elements the practitioner may have understood as aspirational rather than obligatory: PDMP consultation at every visit, documented risk stratification using a validated instrument, a treatment agreement signed by the patient, and evidence that the prescriber considered non-opioid alternatives at each clinical encounter. These elements are features of an idealized practice. They are also features the government treats, when absent, as evidence that the relationship between prescriber and patient was not the kind of relationship the Controlled Substances Act contemplates.
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 patient who travels ninety miles to see a pain management physician because the three physicians closer to home no longer prescribe opioids will, in the government’s analysis, appear as a patient whose travel distance constitutes a red flag. The physician who accepts that patient has undertaken a clinical obligation that the enforcement apparatus will examine with a scrutiny the physician’s more cautious former colleagues avoided by declining to prescribe. The relationship between physician and patient, in this configuration, is not formed in isolation from the regulatory environment. It is formed in response to it, shaped by the scarcity the environment has produced, and then evaluated by the same apparatus that produced the scarcity.
The Record That Constitutes the Relationship
The distinction between a doctor-patient relationship that satisfies the federal standard and one the government will characterize as insufficient is, in nearly every case we have defended or reviewed, a distinction located in the medical record. The clinical encounter may have been thorough. The examination may have been competent. The prescribing decision may have reflected sound medical judgment exercised under the constraints of clinical practice. If the record does not reflect these acts with the specificity the government’s expert will demand, the relationship the prescriber believed existed is not the relationship the government will concede existed.
The record must contain evidence of a history and physical examination. It must contain a diagnosis. It must contain a treatment plan that reflects progression or, where the patient’s condition warrants continuation, a documented rationale for maintaining the current regimen. It must contain evidence that the PDMP was reviewed, that the patient’s risk was assessed, that the prescriber considered the information available and exercised clinical judgment rather than issuing prescriptions as a ministerial act detached from the evaluative process the Controlled Substances Act assumes every controlled substance prescription embodies.
The physician who consults counsel before the agency consults the chart occupies a position from which the record can still be constructed with the precision the standard, as the government applies it, requires. This consultation is where the question of relationship, of documentation, of the distance between clinical practice and regulatory expectation, receives the attention it warrants and seldom receives in the ordinary course of a clinical afternoon. The call concerns what the chart says when no investigation is pending, because the chart is what the investigation will read.
The standard the government applies to the doctor-patient relationship in controlled substance prescribing is a standard that emerges from enforcement rather than from regulation, that acquires its definition in courtrooms and administrative proceedings rather than in the text of the statute that authorizes it, and that operates within a system whose own structural pressures have reshaped the relationships it now evaluates. The prescriber who understands this occupies a different position than the prescriber who prescribes and hopes. The difference is not a matter of clinical competence. It is a matter of institutional awareness, of recognizing that the relationship the law requires is the relationship the record reflects, and that the record, in the end, is what remains when the patient has left the room and the government has entered it.
