Q&A: APA enjoins DEA to maintain telehealth access for controlled medication

Key takeaways:

• The Drug Enforcement Administration has proposed new rules for telehealth access.
• The APA offered a series of recommendations to reduce administrative burdens related to the rules.

In January, the U.S. Drug Enforcement Administration announced new rules to make permanent expanded telehealth access that was established during the COVID-19 pandemic, particularly for individuals on controlled medications.

The rules would allow eligible providers to prescribe a 6-month supply of buprenorphine through a telephone consultation without requiring an in-person visit; establish special registrations that allow eligible providers to prescribe controlled substances without ever conducting an in-person visit with the patient; and exempt Veterans Affairs providers from requiring special registrations.

The DEA recently delayed the dates that the 6-month buprenorphine rule and VA rule go into effect. They were originally set to be finalized on Feb. 18 but now are slated for Dec. 31.

In a statement, the American Psychiatric Association said it is “concerned that this delay in implementation may cause unnecessary confusion and interruptions in care.”

“As the nation continues to grapple with a mental health and substance use crisis, APA encourages the administration to implement regulations that improve access to life saving treatments rather than imposing limitations on the practice of medicine,” the organization added.

Healio spoke to Shabana Khan, MD, chair of the APA’s Telepsychiatry Committee, to discuss the impact of this legislation and the need to provide patients the best possible health care access through telehealth.

Healio: How much of an impact has the COVID-19 telehealth flexibilities had on mental health care?

Khan: While telehealth has been in existence for over 50 years, the COVID-19 pandemic and associated legal, regulatory and reimbursement flexibilities at the federal and state level rapidly expanded the use of telehealth for psychiatric care.

Fifty-five percent of counties across the United States have no psychiatrists and 130 million people live in areas with a shortage of mental health providers.

The APA conducted a member survey in 2023 regarding telepsychiatry practice and potential barriers, in which 94% of respondents noted that they conduct at least some telepsychiatry. Most indicated they operated in a hybrid environment, including a physical practice location, while 16% indicated a lack of physical practice and only see patients remotely. Barriers to telepsychiatry noted by respondents included limited reimbursement, state medical licensure, federal and state regulations regarding controlled substance prescribing via telehealth and technical challenges.

Healio: What is the APA’s stance on the DEA’s proposed rule for special registrations that would allow certain health care providers to prescribe controlled substances via telehealth without having an in-person visit with the patient?

Khan: Current federal flexibilities regarding telemedicine-controlled substance prescribing are set to expire at the end of 2025. We’ve waited 17 years for the DEA to define a special registration process.

There is a great deal of uncertainty for many psychiatric practices as they try to determine which patients they will be able to continue to provide virtual psychiatric care for if or when a special registration is finalized. Many patients could abruptly lose their psychiatric care if the special registration final rule is overly restrictive.

The APA recognizes DEA’s obligation to prevent drug diversion to promote public health. However, key provisions in this proposed rule for special registrations need clarification and adjustment to enhance practicality and effectiveness. There are several aspects of this proposed rule that are overly restrictive, and the administrative burden of this proposed rule is significant:

• The APA appreciates the DEA’s recognition of the current areas of expertise that psychiatrists have and the need to treat patients fully remote.
• We suggest the DEA rescind the proposal of requiring a separate registration for each state in which telemedicine patients will be located.
• A second DEA registration number may complicate and delay the dispensing of legitimate prescriptions for controlled substances.
• The proposed requirement of checking the Prescription Drug Monitoring Programs (PDMP) of all 50 states is not feasible and there is significant variability among state PDMPs. Therefore, we recommend the DEA develop avenues to align PDMP information across states in an expediated way to ensure patients get access to their medication in timely fashion or extend the timeframe for a nationwide PDMP check an additional 5 years.
• Our organization recommends the DEA rescind the proposal of requiring that the special registrant be physically located in the same state as the patient for prescribing of Schedule II controlled substances via telemedicine.
• APA also suggests not moving forward with the DEA proposed requirement that Schedule II controlled substances constitute less than 50 percent of the total number of Schedule II prescriptions, as arbitrary limits on potential life-saving medication will decrease access to quality care.

We further recommend the removal of the proposal to require the presence of the minor’s parent or guardian when the advanced clinician special registrant prescribes a Schedule II controlled substance to the minor. As currently drafted, family dynamics — especially for children in foster care, juvenile justice settings, in intensive treatment settings, school-based treatment settings, or those with parents or guardians who work — would prevent the continuity of care by highly trained physicians.

The APA also requests the DEA provide an exception for physician trainees (residents and fellows) who are affiliated with medical centers allowing them to continue to prescribe controlled substances via telemedicine without the need for a special registration.

The requirements around record-keeping and patient verification may have the unintended effect of clinicians not being able to provide care to underserved areas due to the complex nature, as well as the time and financial costs.

Healio: What other actions do you anticipate the DEA will take to ensure patients have access to substance use treatment?

Khan: The DEA and HHS finalized a rule allowing DEA-registered practitioners to prescribe an initial 6-month supply of buprenorphine via an audio-only or audio-video encounter. After this supply is exhausted, additional prescriptions of buprenorphine can be issued though a special registration, other approved telemedicine encounter, or after an in-person medical evaluation has been conducted. This final rule implementation has been delayed until Dec. 31, underscoring the uncertainty facing patients and the continuation of their care.

Healio: How do you view this DEA action in light of the organization’s plan to reschedule marijuana from a Schedule I to Schedule III substance?

Khan: APA supports continued research of marijuana for medical purposes but does not currently support the recommendation to transfer marijuana from a schedule I controlled substance to a schedule III controlled substance. Maintaining marijuana as a Schedule I substance is crucial to safeguarding public safety and well-being.

Healio: Is there anything else regarding the matter you feel should be addressed?

Khan: We hope that the DEA considers APA’s recommendations and finalizes rules that facilitate, rather than prevent, access to high-quality care.

Rather than a mandatory blanket requirement or an overly restricted special registration process, the need for an in-person examination of a patient should be left to the clinical discretion of the treating practitioner who has the knowledge, skills and experience to make that decision.

References:

APA Letter to DEA Re: Schedules of controlled substances: Rescheduling of marijuana (Docket No. DEA-1362. https://www.psychiatry.org/getattachment/c75f618b-c0fd-4447-94f7-a750ad158e5a/APA-Letter-Department-of-Justice-Rescheduling-07162024.pdf. Published July 16, 2024. Accessed March 24, 2025.

APA letter to DEA: Re: Special registration for telemedicine and limited state telemedicine registrations proposed rule (Docket No. DEA-407) https://www.psychiatry.org/getattachment/d7c12b06-96cf-4062-b16a-9eb262d1ff6f/APA-Letter-DEA-Special-Registration-03182025.pdf. Published March 18, 2025. Accessed March 24, 2025.

ATA action applauds inclusion of Medicare telehealth flexibilities in draft continuing resolution, urges Congress to reinstate provisions as soon as possible. https://tinyurl.com/5n6dbsa4. Published March 8, 2025. Accessed March 24, 2025.

DEA Announces three new telemedicine rules that continue to open access to telehealth treatment while protecting patients. https://www.dea.gov/press-releases/2025/01/16/dea-announces-three-new-telemedicine-rules-continue-open-access. Published Jan. 16, 2025. Accessed March 6, 2025.

Department of Justice, Drug Enforcement Administration. Expansion of buprenorphine treatment via telemedicine encounter. https://www.govinfo.gov/content/pkg/FR-2025-01-17/pdf/2025-01049.pdf. Published Jan. 17, 2025. Accessed March 24, 2025.

Federal Register volume 90, number 55. https://www.govinfo.gov/content/pkg/FR-2025-03-24/html/2025-05007.htm. Published March 24, 2025. Accessed March 25, 2025.

Worthen A, et al. Telemed J E Health. 2024; doi:10.1089/tmj.2024.0042.

For more information:

Information on the work of Shabana Khan, MD, can be found within The American Psychiatric Association Telepsychiatry Toolkit: https://www.psychiatry.org/psychiatrists/practice/telepsychiatry/toolkit