What Type of Doctor-Patient Relationship Is Expected When a Patient Receives Controlled Substances Prescriptions
The doctor-patient relationship required for legitimate controlled substance prescribing is the same relationship required for any other medical prescription: a relationship established through a personal consultation, an examination appropriate to the presenting complaint, a clinical assessment that produces a diagnosis, and a treatment plan of which the prescription is one component.
The Controlled Substances Act and its implementing regulations require that a prescription for a controlled substance be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Federal courts and the DEA have interpreted this requirement to mean that the prescription must emerge from a genuine doctor-patient relationship in which the practitioner has personally examined the patient, assessed their condition, and exercised independent clinical judgment about whether a controlled substance prescription serves a legitimate therapeutic purpose for that specific patient.
The In-Person Examination Requirement
The traditional requirement for an in-person examination before prescribing controlled substances has been modified in specific circumstances by telemedicine regulations, particularly those enacted or expanded during the COVID-19 public health emergency, but the fundamental requirement that the prescribing be based on a genuine clinical assessment of the patient’s condition remains operative in all circumstances.
A practitioner who issues a controlled substance prescription based solely on a patient’s self-report of symptoms, without any independent clinical assessment of those symptoms, without any examination of the patient, and without any objective basis for the diagnosis that the prescription is supposed to treat, has not conducted the clinical assessment required for legitimate prescribing. This is true whether the prescription is issued in person, over the phone, or through a telemedicine platform.
The Elements of the Required Relationship
The doctor-patient relationship required for legitimate controlled substance prescribing includes several elements that the clinical record should reflect. The practitioner must have established the relationship through an encounter in which the patient’s medical history was reviewed, their present complaint was assessed, and their examination was conducted with sufficient thoroughness to provide a clinical basis for the diagnosis and treatment plan. The practitioner must have reviewed the patient’s existing controlled substance prescription history through the PDMP. The practitioner must have exercised independent clinical judgment in determining that a controlled substance prescription was clinically appropriate rather than simply accepting the patient’s request or a prior practitioner’s prescription as the basis for refilling.
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(212) 300-5196Ongoing controlled substance prescribing requires ongoing maintenance of the doctor-patient relationship through regular follow-up visits, reassessment of the treatment’s effectiveness and the patient’s continued need for controlled substances, and monitoring for signs of dependence, misuse, or diversion. The doctor-patient relationship is not established once and maintained indefinitely without reassessment; it requires the continuing exercise of clinical judgment that the initial relationship initiated.
Telemedicine and Its Current Limits
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 prohibits the prescription of controlled substances based on a telemedicine consultation that did not involve the patient and prescriber in the same physical location at some point, with specific exceptions for DEA-registered telemedicine facilities and certain emergency circumstances. The pandemic-era flexibilities that permitted controlled substance prescribing through audio-visual telemedicine without a prior in-person visit have been subject to ongoing regulatory proceedings that affect their current applicability.
The practitioner who prescribes controlled substances through telemedicine must be aware of the current regulatory status of those prescribing authorizations and must ensure that their telemedicine prescribing complies with both the Ryan Haight Act and any state-specific telemedicine prescribing requirements. Prescribing controlled substances through telemedicine in a manner that does not comply with applicable regulations is prescribing outside the usual course of professional practice regardless of whether the clinical assessment was otherwise thorough.
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 doctor-patient relationship that supports legitimate controlled substance prescribing is not a formality. It is not a signature on a form or a documented encounter in the electronic health record. It is an actual professional relationship in which a practitioner has taken personal responsibility for understanding a patient’s medical condition and has exercised clinical judgment about that patient’s treatment. The records that reflect that relationship are the records that defend the prescribing. The records that reflect only the transaction are the records that prosecute it.
The Practitioner’s Personal Responsibility
Controlled substance prescriptions must reflect the clinical judgment of the prescribing practitioner, not the judgment of a colleague, a staff member, or a corporate protocol that generates prescriptions without the practitioner’s independent assessment of each patient. A practitioner who signs controlled substance prescriptions generated by staff review of patient files without personally examining the patients has not exercised the clinical judgment the law requires. The prescription carries the practitioner’s DEA registration number. The legal obligation for the prescription is personal.