DEA proposes new rules for prescriptions issued via telemedicine after the public health emergency ends

On February 24, 2023, the US Drug Enforcement Administration (the DEA) announced proposed rules (the Telemedicine Controlled Substance Proposed Rule and the Telemedicine Buprenorphine Proposed Rule – together, the Proposed Rules) regarding the prescribing of controlled substances via telemedicine beyond the scheduled end of the COVID-19 public health emergency (the PHE) on May 11, 2023.

In their simplest form, these Proposed Rules establish pathways for the prescribing of certain controlled substances in limited quantities via telemedicine without an initial in-person medical examination; however, the Proposed Rules are complex and far more restrictive than the COVID-19-era tele-prescribing flexibilities, drawing criticism from many telehealth providers.

Importantly, the Proposed Rules are only open for public comment for 30 days, after which the DEA will issue final regulations. Comments will be accepted through 11:59 pm on March 28, 2023. Hard copy comments may be submitted by mail to:

Drug Enforcement Administration
Attn: DEA Federal Register Representative/DPW
8701 Morrissette Drive
Springfield, VA 22152

Electronic submissions can be submitted here. Be sure to include Docket No. DEA-407 on all submission materials.

Below, we summarize the Proposed Rules and implications for the telemedicine industry.

The Ryan Haight Act

The statutory basis for the Proposed Rules is the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act), named after the California high school student who died as a result of under-regulated internet pharmacies in the early 2000s. The Ryan Haight Act requires healthcare providers to conduct an in-person examination before prescribing or otherwise dispensing controlled substances “by means of the Internet,” except when engaged in the practice of telemedicine.[1]

The Ryan Haight Act contains seven “practice of telemedicine” exceptions to the in-person medical examination requirement to allow for telemedicine prescribing of controlled substances. These exceptions include:

1. treatment in a hospital or clinic
   
   
2. treatment in the physical presence of a DEA-registered practitioner
   
   
3. treatment by Indian Health Service or Tribal practitioners
   
   
4. treatment during a public health emergency as declared by the Secretary of Health and Human Services
   
   
5. treatment by a practitioner who has obtained a “special registration”
   
   
6. treatment by Department of Veterans Affairs practitioners during a medical emergency and
   
   
7. other circumstances specified by regulation.[2]

During the COVID-19 PHE, the in-person examination requirement under the Ryan Haight Act was waived under the public health emergency exception, allowing DEA-registered prescribers to issue prescriptions for controlled substances via telemedicine without a prior in-person evaluation, provided that the prescription was for a legitimate medical purpose and the practitioner was acting in accordance with state law. With the PHE set to expire in May, the telemedicine prescribing flexibilities would go away. The Proposed Rules would create a new exception under exception #7 above (other circumstances specified by regulation).

The Proposed Rules, issued by the DEA but developed in coordination with the Department of Health and Human Services (HHS) and Department of Veterans Affairs, are intended to alleviate an abrupt cut-off of prescription medications issued via telemedicine, while balancing concerns with respect to appropriate prescribing and potentially harmful practices.

The Proposed Rules

Subject to certain circumstances, the Proposed Rules would permit a medical practitioner to conduct an initial visit with a patient via telemedicine that results in the prescribing of a controlled medication within Schedules III, IV or V (a Telemedicine Prescription), but would not permit prescriptions for Schedule II controlled substances without an in-person evaluation.

More specifically, under the Proposed Rules, medical practitioners are permitted to prescribe an initial 30-day supply of Schedule III, IV and V non-narcotic controlled medications (or a 30-day supply of buprenorphine for the treatment of opioid use disorder (OUD) if issued for maintenance or detoxification treatment) without an in-person examination or referral from a medical practitioner that has conducted an in-person evaluation if:

1. The controlled substance being prescribed is issued during a telemedicine encounter for a legitimate medical purpose by practitioners acting in the usual course of professional practice. A “telemedicine encounter” is defined to mean a “communication between a practitioner and a patient using an interactive telecommunications system as defined by 42 CFR §410.78(a)(3), while the practitioner is engaged in the practice of telemedicine.”
   
   
2. The prescribing practitioner is located within the US or a territory of the US.
   
   
3. The prescribing practitioner is authorized to prescribe controlled substances under applicable federal and state laws, including authorizations to prescribe the basic class of controlled substance under DEA registrations in both the state where the practitioner is located and the state where the patient is located. Practitioners would also be required to comply with any other state law requirements of when prescribing pursuant to a telemedicine encounter.
   
   
4. The prescribing practitioner includes a notation on the face of the prescription, or within the prescription order if prescribed electronically, that the prescription was issued via a telemedicine encounter.

Thus, the Proposed Rules would allow a practitioner to prescribe non-narcotic Schedule III-V controlled substances, up to an initial 30-day supply, via telemedicine encounters. However, for the renewals of such prescriptions beyond the initial 30 days, the practitioner would be required to (a) examine the patient in-person, (b) perform a synchronous audio-video telemedicine encounter with the patient while the patient is located in the physical presence of another DEA-registered practitioner or (c) receive a qualifying telemedicine referral from a DEA-registered practitioner who has conducted an in-person examination of the patient.

Once any of these requirements is satisfied, the Proposed Rules would allow the practitioner to continue prescribing controlled medications to a patient without additional evaluations, unless otherwise required by state or federal law. If the patient requires a Schedule II medication or a Schedule III-V narcotic medication (with the sole exception of buprenorphine for OUD treatment), an initial in-person exam is required prior to a prescription being issued.

Patients who had received a prescription for a controlled substance during the PHE via a telemedicine encounter and without a prior in-person examination would also be subject to the in-person examination requirements under the Proposed Rules; however, DEA has allowed an extension of 180 days for that in-person examination to be performed. This 180-day extension is only available for those patients who had previously received a prescription for a controlled substance via telemedicine during the PHE; it does not apply to patients seeking controlled substance prescriptions after the PHE has ended. Failure to ensure that the prior in-person examination is completed in accordance with the regulations would result in a violation of the Controlled Substances Act, which carries both civil and criminal penalties.

Notably, the Proposed Rules contain many other requirements, including those obliging practitioners to review for the past year, the Prescription Drug Monitoring Program (PDMP) in the state in which the patient is located and to keep detailed records regarding prescriptions issued via a telemedicine encounter at the registered location identified in the practitioner’s DEA registration.

Buprenorphine for opioid use disorder

The Telemedicine Buprenorphine Proposed Rule largely mirrored the Telemedicine Controlled Substances Proposed Rule. However, it is worth emphasizing that, while the DEA expanded the circumstances under which the induction of buprenorphine can occur for maintenance treatment and detoxification treatment OUD via telemedicine, it only allows for up to an initial 30-day supply before an in-person examination would be required.

During the continued opioid crisis, many worry that subjecting buprenorphine prescriptions to the in-person examination requirement would limit access to potentially life-saving medication when it is most needed. This requirement under the Proposed Rules is also in stark contrast with the recent regulatory updates made by SAMHSA in December 2022 and supplemented in February 2023, to remove barriers to the prescribing of medications for OUD, including exempting outpatient treatment programs (OTP) from the requirement to perform an in-person physical evaluation for any patient who will be treated by the OTP with buprenorphine if a program physician, primary care physician or an authorized healthcare professional under the supervision of a program physician, determines that an adequate evaluation of the patient can be accomplished via telehealth. See our previous alert on the SAMHSA Updates to Opioid Treatment Program Standards.

Telemedicine prescription label

As noted above, the Proposed Rules require that prescribers notate on the face of the prescription if the prescription was issued via a telemedicine encounter. Pharmacies receiving such prescriptions are encouraged to take note, particularly as pharmacies have been subject to enforcement, litigation and substantial penalties relating to their opioid dispensing practices and have further been subject to intense scrutiny with respect to the dispensing of Mifepristone, a medication abortion drug.  As a result, pharmacies could decide not to fill prescriptions issued via telemedicine, either for certain drugs or for all drugs.

Further implications for the future of telemedicine practice

Compared to the original Ryan Haight Act, these new options offer expanded flexibilities to allow for more telemedicine-based care. However, these Proposed Rules are noticeably more restrictive than the tele-prescribing permitted during the PHE. Thus, these Proposed Rules are likely to result in regulatory hurdles that place a burden on patients and providers alike.

Although the Proposed Rules were designed to “continue greater access to care for patients across the country,” the effect of the Proposed Rules will likely be the opposite for telemedicine practices that have been operating under expanded flexibilities in the past three years.[3] Given the restraints imposed under the Proposed Rules, patients who were unable to obtain in-person medical care and receive controlled medications prior to the PHE will face similar challenges to access as the PHE ends.

Furthermore, providers will face continued regulatory obstacles and uncertainties in the provision of telemedicine services. For example, the Proposed Rules do not contain the long-awaited telemedicine special registration regulations (exception #5 above), which would allow certain clinicians the ability to prescribe controlled substances via telemedicine without conducting an in-person examination of a patient.

The DEA’s decision to omit the telemedicine special registration from the Proposed Rules presents lasting uncertainty for telemedicine providers who have been expecting the promulgation of these regulations for years. Similarly, neither the Ryan Haight Act nor the Proposed Rules preempt more restrictive state laws. As state laws vary widely both in form and in the specific requirements applicable to telemedicine providers, and without clear directives in the Proposed Rules, providers, especially those spread across the US, will need to continue to analyze their service offerings in conjunction with applicable state laws and the Proposed Rules to derive a compliant approach to prescribing controlled substances.

Given the complex nature of the Proposed Rules and the regulatory landscape, we encourage healthcare entities and providers to begin working with healthcare counsel to carefully evaluate their practices and the shifting regulatory landscape. Where needed, providers should re-evaluate their business strategies and conform current treatment models to comply with the Proposed Rules’ requirements.

If you have any questions about the Proposed Rules or related matters, please contact your DLA Piper relationship partner, the authors of this alert or any member of our healthcare industry group.