Healthcare Law Blog

DEA Proposes New Tele-Prescribing Rules for End of COVID-19 State of Emergency

At the end of January, the Biden Administration announced that May 11, 2023, would mark the end of the federal public health emergency (PHE) declarations that have been in place for the last three years. For healthcare providers, this means change is on the horizon, especially where telemedicine is concerned. In response to the impending end of emergency telehealth provisions, the Drug Enforcement Agency (DEA) has proposed a permanent rule regarding the prescription of controlled medications via telemedicine in order to extend COVID-era accommodations. The public will be able to comment for 30 days on the proposed rules. A summary of the rules can be found here: Proposed Telemedicine Rules Summary.

During the state of emergency, rules were temporarily adjusted to allow healthcare practitioners to prescribe certain controlled medications via telehealth appointments—without the preceding in-person visit previously required. Many providers and patients came to rely on this new rule when providing and receiving care. When the emergency provisions expire in May, this one will go with it, if not for the DEA’s proposed Tele-Prescribing Rules. One proposed rule will no longer permit telehealth providers to prescribe controlled substances through telehealth if the patient never had an in-person examination, subject to limited exceptions. Another proposed rule would expand the situations where doctors may prescribe buprenorphine, used in pain and withdrawal management.

Pursuant to the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Act), which serves as the basis for the proposed rules, unless an exception applies,[1] controlled substances may not be distributed online without a valid prescription. Additionally, a provider must conduct at least one in-person patient visit before prescribing a controlled substance over the internet. The failure to conduct an in-person examination constitutes a violation of the Controlled Substances Act and carries potential civil and criminal penalties. When the PHE went into effect in 2020, the DEA suspended the in-person exam requirement and allowed providers to prescribe controlled substances via telehealth as long as the prescription was for legitimate medical purposes and the prescribing practitioner was acting in accordance with applicable laws.

Under the proposed rule, Schedule II controlled substances such as Ritalin, Adderall and Vicodin and Schedule III-V narcotics other than buprenorphine may not be prescribed to patients without an in-person evaluation. Providers would 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.[2]

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 180 days.

Other key provisions in the proposed rules include the following:

• This rule does not affect prescriptions of drugs that are not controlled substances.
• This rule does not affect telemedicine consultations by a medical practitioner that has previously conducted an in-person medical examination of a patient.
• The prescriptions are required to be consistent with state law.
• This rule does not affect 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 proposed rules would provide safeguards for a narrow subset of telemedicine consultations—those telemedicine consultations by a medical practitioner that has: never conducted an in-person evaluation of a patient; AND that result in the prescribing of a controlled medication. For these types of consultations, the proposed telemedicine rules would allow medical practitioners to prescribe without an in-person evaluation or referral from a medical practitioner that has conducted an in-person evaluation, as long as the prescription is otherwise consistent with any applicable Federal and State laws, the following:

• a 30-day supply of Schedule III-V non-narcotic controlled medications;
• a 30-day supply of buprenorphine for the treatment of opioid use disorder

Although the proposed rules offer a reprieve to the potential abrupt end to telehealth prescribing of controlled substances, many industry stakeholders, including the American Telemedicine Association, have expressed concern that they are more restrictive than necessary to address the DEA's concerns regarding potentially harmful and abusive prescribing practices while dealing with an opioid epidemic. There is not much time for public input. Comments on both of these proposals are due on or before March 31, 2023. If the proposed rules are not changed, only time will tell whether they have a positive or negative impact on patient care, including patients struggling with OUD. Importantly, however, state law largely governs remote prescribing and should not be overlooked when evaluating telemedicine requirements.

The end of the state of emergency for COVID-19 promises to be yet another period of change and adaptation for the healthcare industry. If you need help making sense of it all, contact McBrayer’s experienced healthcare attorneys today.

Lisa English Hinkle is a Member of McBrayer law. Ms. Hinkle chairs the healthcare law practice and is located in the firm’s Lexington office. Contact Ms. Hinkle at lhinkle@mcbrayerfirm.com or (859) 231-8780, ext. 1256.

Jonas Bastien is an Associate of McBrayer Law. He practices with the healthcare and litigation groups in the firm's Lexington office. Mr. Bastien can be reached at jbastien@mcbrayerfirm.com or (859) 231-8780, ext. 1029.

[1] The Act contains seven exceptions to the in-person exam requirement for telehealth prescribing of controlled substances: 1) the patient is being treated in a hospital or clinic; 2) the patient is being treated in the physical presence of a DEA-registered practitioner; 3) the telemedicine consult is conducted by a DEA-registered practitioner for the Indian Health Service; 4) the telemedicine consult is conducted during a DHHS-declared PHE; 5) the provider has obtained a DEA special registration for telemedicine; 6) the consult is conducted by a Veterans Health Administration practitioner during a VHA-recognized medical emergency; and 7) other circumstances specified by DEA regulations.

[2] The other options for prescription renewals are to either perform a synchronous audio-video encounter with the patient while the patient is in the physical presence of another DEA-registered practitioner or receive a qualifying telemedicine referral from a DEA-registered practitioner who has conducted an in-person exam of the patient.