Consistent with the Biden Administration's timeline to end the COVID-19 national and public health emergencies on May 11, 2023, the U.S. Department of Health and Human Services (HHS) informed states to expect the Public Health Emergency (PHE) and certain associated flexibilities to end on the same date. The announcement prompted the need to address temporary policy changes that were put in place during the PHE and that are set to expire with it.
One major policy change impacts the flexibility to prescribe certain controlled substances via telehealth.
Previously, if a public health emergency was declared, federal law would allow for an exception to the requirement that a patient be seen in person before prescribing a controlled substance via telehealth. With the PHE coming to an end, many are concerned that patients will lose access to needed medications.
On February 24, 2023, the U.S. Drug Enforcement Administration (DEA) released two proposed rules to reinstate the requirements that:
- A patient sees a doctor in person before being prescribed certain Schedule II controlled substances like Adderall and OxyContin.
- Providers be able to prescribe a 30-day supply for buprenorphine and non-narcotic Schedule III-V drugs, such as Xanax and Ambien, without an in-person visit if the telemedicine encounter is for a legitimate medical purpose. Anything beyond a 30-day supply will require an in-person visit.
If a patient had already been receiving prescriptions by telemedicine during the PHE, the DEA will defer the in-person exam requirement for an additional grace period of 180 days. Notably, the grace period does not appear to be applicable to buprenorphine.
Since the DEA only provided a 30-day public comment period starting from March 1, 2023, a final rule is expected in time for the new regulation to go into effect when the PHE ends.
What Physicians Need to Know to Prepare for New Telehealth Rules:
Medical practices are well accustomed to responding and adapting to regulatory changes. Physicians should be aware of the DEA’s long-awaited proposed rules related to telehealth.
Anne Milgram, DEA Administrator, stated “…DEA is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm.”¹
The proposed rules do not affect:
- Telemedicine consultations that do not involve the prescribing of controlled medications.
- Telemedicine consultations by a medical practitioner who has previously conducted an in-person medical examination of a patient.
- Telemedicine consultations and prescriptions by a medical practitioner to whom a patient has been referred, as long as the referring medical practitioner has previously conducted an in-person medical examination of the patient.
The following are other key provisions in the proposed rules
- Practitioners would have to keep records of all qualifying telemedicine referrals, and such records would need to be kept at the registered location that is listed on the prescriber's certificate of registration.
- All subsequent prescriptions via telehealth (which includes audio-only in some circumstances) would have to follow at least one in-person visit between the patient and a DEA registered practitioner.
- Prescriptions stemming from telemedicine encounters could be only for the purpose of maintenance or detoxification.
Xavier Becerra, Secretary of HHS, has made it known that “[i]mproved access to mental health and substance use disorder services through expanded telemedicine flexibilities will save lives. We still have millions of Americans, particularly those living in rural communities who face difficulties accessing a doctor or health care provider in-person…”¹
Although the federal proposed rules are intended to mitigate the potential abrupt end to telehealth prescribing of controlled substances, state law also governs remote prescribing and should not be overlooked when evaluating telemedicine requirements. State law could potentially provide an opening for less restrictive prescribing during an ongoing opioid crisis.
To learn more about how the proposed rules may affect you and your patients, please visit:
www.CAPphysicians.com/DEA1
To learn how the proposed rules may affect certain prescriptions, please visit:
www.CAPphysicians.com/DEA2
Additional information can be found here.
Gabriela Villanueva is CAP’s Government and External Affairs Analyst.
Dona Constantine is a CAP Senior Risk Management & Patient Safety Specialist.
Questions or comments related to this article should be directed to GVillanueva@CAPphysicians.com or DConstantine@CAPphysicians.com.
¹Drug Enforcement Administration (2023, February 24) DEA Announces Proposed Rules for Permanent Telemedicine Flexibilities [Press release]. https://www.dea.gov/press-releases/2023/02/24/dea-announces-proposed-ru…