DEA Announces Proposed Telemedicine Rule Change for Controlled Substances
On 2/24/23 the U.S. Drug Enforcement Agency (DEA) announced a proposal for permanent rule changes to the Ryan Haight Act that will allow for the prescription of controlled substances through telemedicine, under certain circumstances, after the federal COVID-19 Public Health Emergency (PHE) expires on May 11, 2023.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires prescribers conduct an in-person examination to evaluate each patient at least once before prescribing a controlled substance, even if a patient has already been taking the medication in question. During the PHE, the in-person requirement was changed to allow prescribers to perform the initial evaluation through videoconferencing. Thus, prescribers were able to form treatment relationships and prescribe controlled substances to patients whom they have never examined in person; however, this exception will end with the PHE in May.
The proposed rules would apply only to situations in which the provider is prescribing controlled substances to a patient whom he/she has never examined in person. The new rules would allow for the following prescriptions based solely on a telemedicine evaluation, without the need for an in-person examination:
- 30-day maximum supply of Schedule III-V non-narcotic controlled substance medications
- 30-day maximum supply of buprenorphine for the treatment of opioid use disorder
Importantly, the new rule does not allow telemedicine prescribing of Schedule II controlled substances or opioids (narcotics), other than buprenorphine for the treatment of addiction (subject to separate proposed rules). Those medications will still require an initial in-person evaluation before prescribing.
The new DEA rules do not address the “special registration” process referenced in the Ryan Haight Act but never implemented by the DEA; this would have allowed providers to register with the DEA for telemedicine prescribing. Instead, the new rules create an additional category of telemedicine prescribing for circumstances that fall under the rules.
The new rules create two new options for prescribing controlled substances via telemedicine:
- A “telemedicine prescription” based on a telemedicine-only evaluation; prescriptions are limited to Schedule III-V non-narcotic medications (except buprenorphine) and limited to a maximum 30-day supply.
- A “qualified telemedicine referral” in which a practitioner examines a patient in person and refers the patient to the prescriber who evaluates the patient through telemedicine; prescriber can prescribe Schedule II-V controlled substances including narcotics.
In most situations, telemedicine evaluations must consist of interactive audio-video communication (i.e. videoconferencing). However, there are limited situations in which audio-only telemedicine can be used for patients being evaluated and/or treated for a mental health disorder. The evaluation must be conducted while the patient is located at their “home,” including temporary lodging or locations near the patient’s home. Additionally, the treating provider must have the capability to provide videoconferencing and offer that to the patient, and the patient must either decline or not have access to those services.
There are additional requirements for telemedicine prescriptions under the new rules; these include specific documentation that must be included in patient charts, and specific notation on prescriptions indicating that they are based on a telemedicine evaluation.
Under the new rules, prescribers are also required to check state prescription drug monitoring program (PDMP) information for each patient prior to issuing a telemedicine prescription. If PDMP information is unavailable, the controlled substance prescription must be limited to 7 days.
Of note, prescribers issuing “telemedicine prescriptions” across state lines must be registered with the DEA both in their home state and in the state in which the patient is physically located (this is in addition to state medical licensure requirements).
After the initial 30-day prescription based on a telemedicine evaluation, further prescriptions must be based on one of the following:
- An in-person examination by the prescriber.
- A three-party evaluation involving examination by an in-person treating provider who is registered with the DEA, the patient, and the prescriber participating remotely via interactive audio-visual connection.
- A “qualifying telemedicine referral” to the prescriber by another DEA-registered practitioner who had conducted an in-person exam of the patient.
Importantly, the DEA is implementing a 180-day extension of the PHE waiver to allow for transitions in care to occur for physician-patient relationships that were established through telemedicine while the COVID-19 PHE was in effect. For providers who prescribed a controlled substance between the dates of March 16, 2020 and May 11, 2023 to any patient whom they have never evaluated in person, they are permitted to continue prescribing any Schedule II-V controlled substance, including narcotics, to those patients for 180 days after the PHE expires (until approximately mid-November 2023). After that, prescribers will be required to comply with the new rules as explained above. Additionally, any new physician-patient relationships created after May 11th will be subject to the new rules, and not subject to the 180-day extension.
Physicians should note that the in-person evaluation requirements of the Ryan Haight Act are not the only rules and regulations to consider when prescribing controlled substances. First, the Ryan Haight Act contains the requirement that controlled substances may only be prescribed for a “legitimate medical purpose issued within the usual course of professional practice.” This means that compliance with the requirements for in-person or telemedicine evaluation does not necessarily demonstrate compliance with the law, if the medication was otherwise not appropriately indicated based on a patient’s condition or the physician’s scope of practice.
Also, prescribers are bound not only by federal laws, but also by state laws that regulate the practice of medicine (i.e. state licensure) and which may impose additional requirements for controlled substance prescribing. This is particularly relevant in telemedicine, in which the patient’s physical location at the time of an encounter determines which state laws would apply. Physicians must ensure that they are properly licensed in those states, aware of any state-specific prescribing laws, and compliant with those laws as well as with the federal Ryan Haight Act.
Importantly, physicians must not only practice within the bounds of federal and state law, but they must also treat patients in accordance with the applicable standard of care to avoid exposure to malpractice liability. Applicable standards of care may necessitate in-person visits, either initially or in follow-up, for certain patients or clinical scenarios even if telemedicine-only care is allowable under federal and state law. Physicians should consider these situations in their own practices and determine the best approaches to ensure patient safety and efficacy of care, even if those approaches are not expressly required under the law.
The DEA has not finalized the new rules, and it is soliciting comments and feedback from the public until March 28th before finalizing the rules in May. However, physicians and other healthcare providers who prescribe controlled substances should familiarize themselves with the new rules as described above, and plan to comply with the new prescribing requirements after May 11th.
Physicians should also identify the patients to whom they are prescribed controlled substances without having undergone an in-person examination. Those patients can continue to receive controlled substances without an in-person examination under the extended PHE waiver until November 2023, but physicians should take advantage of the extended time and begin to adjust their care plans well ahead of November. As explained above, new patients who initiate treatment after 5/11/23 are not eligible for the extended waiver and are subject to the new rules.
MIEC will keep our members updated on this developing issue. In the meantime, for more information please refer to MIEC’s Telehealth page and our Knowledge Library article Telehealth and Prescribing Controlled Substances.