The Drug Enforcement Agency (“DEA”) has recently issued notices of proposed rule makings regarding the prescribing of certain controlled substances via telemedicine. The two proposed rules, in a nutshell, are as follows:
- The DEA’s proposed Expansion of Induction of Buprenorphine via Telemedicine Encounter rule (the “Buprenorphine Rule”) would expand the circumstances under which individual practitioners are authorized to prescribe schedule III-V narcotic drugs (in particular, buprenorphine) or combinations of such drugs that have been approved for use in continuous medical treatment or withdrawal management treatment via telemedicine.
- The DEA’s proposed Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation (the “No In-Person Examination Rule”) rule would specify the circumstances under which practitioners can prescribe controlled substances via telemedicine without the mandatory in-person medical evaluation prior to the issuance of the prescription.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“Haight Act”) governs the distribution and dispensing of controlled substances by means of the internet. The Haight Act generally requires the dispensing of controlled substances by means of the internet be predicated on a valid prescription involving at least one in-person evaluation. In other words, the Haight Act is applicable only when a prescribing practitioner wishes to prescribe controlled substances via telemedicine and has not otherwise conducted an in-person evaluation prior to the issuance of the prescription. However, seven distinct exceptions apply:
- The patient is being treated in a DEA-registered hospital or clinic.
- The patient is being treated in the physical presence of a DEA-registered practitioner.
- The telemedicine consult is conducted by a DEA registered practitioner for the Indian Health Service, who is designated as an Internet Eligible Controlled Substances Provider by the DEA.
- The telemedicine consult is conducted during a public health emergency declared by the Secretary of the U.S. Department of Health and Human Services.
- The telemedicine consult is conducted by a practitioner who has obtained a DEA special registration for telemedicine.
- The telemedicine consult is conducted by a Veterans Health Administration practitioner during a medical emergency recognized by the VHA.
- The telemedicine consult is conducted under other circumstances specified by future DEA regulations.
Pursuant to exception #4 above, the COVID-19 public health emergency gave rise to more lenient (but temporary) rules under the Haight Act, several of which the DEA now proposes to adopt permanently.
The Buprenorphine Rule
The proposed Buprenorphine Rule would expand the circumstances under which practitioners are authorized to prescribe any schedule III, IV, or V narcotic drug approved by the Food and Drug Administration (“FDA”) specifically for use in the maintenance or detoxification treatment of an opioid-use disorder (“OUD”) via a telemedicine encounter, including audio-only encounters. The only schedule III-V narcotic drug that is currently approved by the FDA for such treatment is buprenorphine. Under the Buprenorphine Rule, the DEA is proposing to allow buprenorphine to be prescribed via telemedicine when:
- The practitioner must possess the appropriate DEA dispensing registration in the state whether the practitioner is located;
- The practitioner must be authorized (or not otherwise prohibited) by state law to engage in the practice of telemedicine in the both the state where the practitioner is located and where the patient is located and be technically capable of using audio and video equipment permitting two-way, real-time interactive communication with the patient at the time of the telemedicine encounter;
- Buprenorphine cannot be prescribed for pain or any other purpose besides the treatment of OUD;
- Practitioners would be required to review and consider relevant prescription drug monitoring program (“PDMP”) data in the state the patient is located prior to prescribing;
- Practitioners may prescribe no more than a 30-day supply until the required medical evaluation has been conducted. The medical evaluation must (1) be an in-person evaluation with the prescribing practitioner, or (2) in the presence of another DEA-registered practitioner; and
- Practitioners would be required to keep sufficient records regarding the nature of the tele-visit and issued prescriptions.
The proposed Buprenorphine Rule is a part of the DEA’s efforts to combat the ongoing drug poisoning crisis by increasing the access to potentially lifesaving substances that would otherwise be unutilized, while also providing controls against diversion. The DEA estimates this proposed rule would affect 37,373 providers and 67,458 patients, annually. There would be a slight increase in labor costs per practitioner, due to increased time spent reviewing PDMP databases. The estimated total cost to the 37,373 providers is $709,970, annually. DEA estimates recordkeeping requirements are likely to have a minimal impact because current recordkeeping practices are likely to meet the requirements imposed by the proposed rule, and any additional time is expected to be minimal. The increase in the availability and flexibility of treatment with schedule III-V controlled substances may increase the risk of diversion, however DEA believes that any increase would be small, and outweighed by the benefit to patients and reduction in the societal cost of opioid use disorder.
The No In-Person Examination Rule
Notwithstanding the proposed Buprenorphine Rule, the DEA has also issued the proposed No In-Person Examination rule, which would allow practitioners to prescribe non-narcotic schedule III-V controlled medications via telemedicine without a prior in-person medical evaluation.
The conditions to be met to utilize this proposed rule include:
- Telemedicine may only be used to issue a prescription if that prescription is issued pursuant to a telemedicine encounter and is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice;
- The practitioner may not prescribe while located outside the United States and must be authorized to prescribe the particular class of controlled substance under the State in which the practitioner is located, and in which the patient resides;
- The prescription must include language which clearly states the prescription is issued pursuant to a telemedicine encounter; and
- Similar to the proposed Buprenorphine Rule, practitioners may only prescribe non-narcotic schedule III-V controlled medications for a period of 30 days if no in-person medical evaluation has taken place. The medical evaluation must be completed by the prescribing practitioner, or a practitioner registered by the DEA who subsequently issues a referral to the prescribing practitioner.
The DEA estimates any cost associated with this rule to be minimal. Also, the DEA believes that annual cost savings of the proposed No In-Person Examination rule and the benefits of increased availability for treatment outweigh the dangers of a potential increase in diversion of the controlled substances.