By Shannon Britton Hartsfield
and Nili Yolin
The COVID-19 public health emergency (PHE) is set to expire on May 11, 2023, and there seems to be a scramble to extend some of the pandemic-related flexibilities involving telehealth. The U.S. Drug Enforcement Administration (DEA) recently released two notices of proposed rulemaking to allow some of those flexibilities to continue, but the proposed rules are nevertheless more restrictive than what has been permitted since the PHE went into effect. One proposed rule will no longer permit telehealth providers to prescribe controlled substances 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.
Telehealth Prescribing of Controlled Substances
Pursuant to the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Act), which serves as the basis for the proposed rules, unless one of seven exceptions applies, 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 federal and state 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.
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.
Prescribing Buprenorphine for Opioid Use Disorder
Balancing the safety measures imposed by the Act with the need to expand access to certain narcotics, the DEA wants to expand access to buprenorphine due to the substantial increase in fatal drug poisonings involving illegal synthetic drugs. The proposed rule would allow authorized providers to prescribe buprenorphine for use in the treatment of opioid use disorder (OUD) via telemedicine, including through an encounter that is audio-only. According to the DEA, the amount of fentanyl seized in 2022 is enough “to supply a potentially lethal dose to every member of the U.S. population.” The proposed rule would increase access to buprenorphine and lower the risk of death.
Misuse of buprenorphine can also lead to death, however. The Act allows prescribing of controlled substances through the internet for legitimate medical conditions even without an in-person evaluation as long as the drugs have been approved for maintenance or withdrawal management treatment of OUD and the telemedicine practitioner can conduct a bona fide patient evaluation. Buprenorphine is currently the only Schedule III-V narcotic that is FDA-approved for use in continuous medical treatment or detoxification for patients with OUD. The rule would allow prescribing through audio-only encounters if the patient is unable to or does not wish to use audio/video technology. The proposed rules contain guardrails against diversion, however, including a requirement that practitioners review and consider Prescription Drug Monitoring Program (PDMP) data prior to prescribing buprenorphine so that a patient engaging in drug-seeking behavior does not receive multiple prescriptions. Additionally, patients would either have to be examined in person by the prescriber within 30 days, or the prescriber would have to examine the patient remotely while the patient is in the physical presence of another DEA-registered practitioner participating in a synchronous audio-video telemedicine encounter with the prescriber.
Other key provisions in the proposed rules include the following:
• This rule would not affect prescriptions of drugs that are not controlled substances.
• The prescriptions would also have to be consistent with state law.
• 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.
• Prescriptions stemming from telemedicine encounters could be only for the purpose of maintenance or detoxification.
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. 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.
Shannon Britton Hartsfield and Nili Yolin, who practice in Florida and New York, respectively, are partners at Holland & Knight LLP, where they advise healthcare providers on compliance issues involving federal and state healthcare laws and regulations.