On February 24, 2023, the Drug Enforcement Administration (DEA) proposed permanent rules that would extend certain telehealth flexibilities introduced during the COVID-19 Public Health Emergency, which is set to end on May 11, 2023.
The proposed rules would allow the prescribing of certain controlled medications via telemedicine without needing an in-person evaluation, expanding patient access to critical therapies beyond the scheduled end of the Public Health Emergency.
DEA and HHS Extend Telemedicine Flexibilities through 2024
On May 3, 2023, the DEA announced that it submitted, in concert with the Department of Health and Human Services, a draft temporary rule to the Office of Management and Budget. The temporary rule will extend pandemic-era flexibilities past the scheduled end of the Public Health Emergency while the DEA considers “a record 38,000 comments” it received on its proposed permanent telemedicine rules.
On August 7, 2023, the DEA announced it will host public listening sessions to receive additional input from healthcare practitioners, experts, advocates, patients, and other members of the public. These listening sessions will help inform DEA’s regulations on prescribing controlled substances via telemedicine and potential safeguards that could effectively prevent and detect the diversion of controlled substances prescribed via telemedicine.
On October 6, 2023, the DEA, jointly with the Department of Health and Human Services (HHS), extended current telemedicine flexibilities through December 31, 2024.
DEA is working to promulgate new standards or safeguards by the fall of 2024.
DEA Considering Conditions for the Prescribing of Controlled Medications Via Telemedicine
The DEA is open to considering – for some controlled substances – the implementation of a separate Special Registration for telemedicine prescribing for patients without requiring the patient to ever have had an in-person medical evaluation at all.
DEA also observes that “making permanent some telemedicine flexibilities on a routine and large-scale basis would potentially create a new framework for medicine that fundamentally expands access to controlled substances in a way that warrants a new framework for accountability based, in part, on increased data collection and visibility into prescription practices in order to ensure patient safety and prevent diversion in near-real-time.”
While DEA welcomes all relevant information or opinions regarding telemedicine at its special listening sessions, DEA is particularly interested in the following questions:
- If telemedicine prescribing of schedule III–V medications were permitted in the absence of an in-person medical evaluation, what framework, including safeguards and data, with respect to telemedicine prescribing of schedule III–V medications do you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?
- Should telemedicine prescribing of schedule II medications never be permitted in the absence of an in-person medical evaluation? Are there any circumstances in which telemedicine prescribing of schedule II medications should be permitted in the absence of an in-person medical evaluation? If it were permitted, what safeguards with respect to telemedicine prescribing of schedule II medications specifically would you recommend to help DEA ensure patient safety and prevent the diversion of controlled substances?
The healthcare attorneys at Hendershot Cowart will continue to monitor the progress of this proposed rule.
Which Telemedicine Flexibilities Could Be Impacted?
Not all the pandemic-era flexibilities will be protected under the proposed rules. Instead, the DEA is focusing on protecting access to mental health and substance use disorder services through expanded telemedicine flexibilities.
The proposed rules would provide safeguards for telemedicine consultations that meet these limited criteria:
- Those in which a medical practitioner has never conducted an in-person evaluation of a patient; AND
- which results in the prescribing of a controlled medication.
The proposed rules DO NOT affect:
- Telemedicine consultations that do not involve the prescribing of controlled medications.
- Telemedicine consultations by a medical practitioner that has previously conducted at least one in-person medical examination of a patient.
The proposed rules also will not affect telemedicine consultations with a patient who was referred by another medical practitioner who previously had conducted an in-person evaluation of that patient. However, prescriptions written by medical practitioners via telemedicine based on a referral will require additional recordkeeping obligations.
Please review our website for more information on telemedicine laws in Texas.
DEA’s Proposed Telemedicine Rules
The proposed rules would allow DEA-registered practitioners to prescribe Schedule III-V non-narcotic controlled medication via telemedicine consultation to a patient:
- Not previously evaluated in person; and
- Not referred by a medical practitioner who evaluated the patient in person.
For these types of consultations, medical practitioners will be able to prescribe up to a 30-day supply of Schedule III-V non-narcotic controlled medications or a 30-day supply of buprenorphine for the treatment of opioid use disorder.
An in-person visit would be required for refills of these prescriptions.
The full text of the proposals may be found at the links below. The rules will be open for public comment for 30 days, which the DEA will then consider before drafting final regulations.
- Expansion of Induction of Buprenorphine via Telemedicine Encounter
- Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation
Prescribing Controlled Substances Via Telemedicine – Before, During & After COVID-19
Under the U.S. Controlled Substances Act of 2008 (21 U.S.C. 829(e)), a practitioner can only prescribe controlled substances after conducting an in-person examination of the patient. The Act was passed to curb online pharmacies offering controlled substances – including opioids – without a valid doctor-patient relationship.
The U.S. Controlled Substances Act does include some exceptions to the in-person medical evaluation requirement, including treatment during a Public Health Emergency, such as the one declared by the Secretary of Health and Human Services on January 31, 2020.
While the Public Health Emergency (PHE) remains in effect, DEA-registered practitioners may issue prescriptions for all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation via telemedicine consultation.
Requirements for a PHE exception to controlled substance prescriptions include:
- Acting in the usual course of their professional duties, the physician or prescribing practitioner issues the prescription to treat a valid medical purpose.
- In issuing the prescription, a two-way, interactive telemedicine appointment is conducted via a real-time, audio-visual system.
- The physician or prescribing practitioner complies with all relevant State and Federal laws.
With the Public Health Emergency set to expire on May 11, 2023, the DEA proposed its rules to ensure that patients do not experience lapses in care.
Although the new rules would expand the use of telemedicine for prescribing controlled substances beyond what was allowed before the Public Health Emergency, they would re-establish some limitations by requiring at least one in-person visit.
Which Medications Can be Prescribed Through Telemedicine?
DEA’s proposed rules impact controlled medicines. Because controlled medicines have the potential to cause physical or psychological dependence, they are subject to strict DEA regulation and are classified into different schedules based on their potential for abuse with Schedule I substances being considered the most dangerous and Schedule V substances being considered the least dangerous.
The DEA rules would impact Schedule III, IV, and V medications. Examples of these include anabolic steroids, buprenorphine, Ambien, Tramadol, Valium, Xanax, Lomotil, and Lyrica. The DEA published guidance to patients to help determine if their prescription will be impacted by the proposed telehealth rules. Here is a complete list of controlled substances (I-V).
Texas Laws on Prescribing Controlled Substances
Texas providers must follow all federal telemedicine and prescribing regulations. In addition, telehealth prescribers in Texas are required to adhere to the same standard of care as an in-person setting. This means that the validity of a prescription issued as a result of a telemedicine service is determined by the standards that would apply to the issuance of the prescription in an in-person setting. As always, the prescription must be issued for a legitimate medical purpose.
Are Your Practice’s Telemedicine Services Compliant?
The proposed changes to federal regulations surrounding the prescribing of controlled substances via telemedicine are important for healthcare providers to consider, as they can have a significant impact on their telemedicine prescribing flexibilities.
Consult with a healthcare attorney to ensure that your practice, clinic, or facility is compliant with all legal requirements and that any new rules are adhered to as the nation, and state and federal governments, transition out of the COVID-19 Public Health Emergency.
Our attorneys have extensive experience working with healthcare providers of all sizes, including single-physician practices, clinics, and large healthcare systems. We are actively monitoring the proposed changes so that our clients remain well-informed and up-to-date with respect to their rights and responsibilities under the law.
Do you have questions about the DEA’s proposed changes to telehealth and telemedicine laws? Contact our Houston-based law firmfor answers and professional legal guidance.
