Loyola University Chicago School of Law, JD 2024
On January 31, 2020, the Secretary of the Department of Health and Human Services issued a public health emergency as a result of COVID-19. The emergency declaration requires public health professionals, first responders, and public officials to work together to minimize death while preventing illnesses. The declarations provided the government with the flexibility to waive or modify standard requirements as it relates to both public and private insurance, service providers, and authorizations including telehealth. Telehealth provided access to healthcare to those who face barriers as well as flexibility in being able to manage care while reducing the spread of COVID-19 along with other infectious diseases. There remained uncertainty regarding the freedom to prescribe controlled substances via telemedicine with the Biden administration set to end the public health emergency on May 11, 2023. However, on February 24, 2023, the Drug Enforcement Administration (DEA) released a proposed rule that aims to permanently extend controlled substance prescribing flexibilities.
Proposed rule flexibilities and safeguards
The proposed rule intends to add flexibility to the Ryan Haight Online Consumer Protection Act of 2008, which restricts prescribing controlled substances via telemedicine to practitioners that conduct an in-person medical evaluation of the patient. The proposed rule would permit controlled substance prescribing for a narrow set of telemedicine consultations. This would allow practitioners to prescribe non-narcotic Schedule III-V controlled substances via telemedicine without a prior in-person medical evaluation. Safeguards would limit the prescription to a 30-day supply, thereby requiring the practitioner to conduct an in-person medical evaluation to continue the prescription. Additionally, the proposed rule revises the DEA regulatory definition of the “practice of telemedicine” to require that telemedicine take place using an interactive telecommunication system. As a result, this would allow the prescribing of controlled substances via telemedicine using audio-only equipment in limited circumstances. Moreover, the proposed rule provides for a “qualifying telemedicine referral,” which would provide for those patients that are unable to have an in-person evaluation following the initial 30-day controlled substance supply. A qualified practitioner that receives a qualifying telemedicine referral may prescribe any controlled substance if the referral is from a DEA-registered practitioner who has previously conducted a medical evaluation of the patient.
As a safeguard, the proposed rule requires prescribing practitioners to review relevant prescription drug monitoring program data. However, if it is unavailable, the prescribing practitioner must limit controlled substance prescriptions to a 7-day supply until the data can be reviewed. Unless the patient is a qualifying telemedicine referral, prescribing schedule II-controlled substances and all narcotic-controlled substances are excluded from the rule’s scope. Nevertheless, the DEA issued a separate proposed rule, ‘The Expansion of Induction of Buprenorphine via Telemedicine Encounter.’ This creates an exception to the non-narcotic prescribing requirement and proposes to allow prescribing of certain narcotic-controlled substances, such as buprenorphine via telemedicine for the treatment of opioid use disorder.
Proposed rule concerns and consequences
The DEA’s proposed rule is intended to prevent patients from experiencing lapses in care while providing continuity of care. Subsequently, the DEA and HHS have provided a 30-day notice and comment period. While telehealth has its benefits in lessening barriers for some it creates a barrier for others. Due to the limited availability of qualified physicians to treat certain behavioral conditions with controlled substances, telemedicine can allow a broader range of patients to be reached. Specifically, the proposed rule would benefit those who face a lack of transportation, care for elderly family members, or struggle to find childcare.
On the other hand, not everyone has access to the technology that telehealth requires – whether it be a computer or even a phone, considering those that face housing insecurity. While there is no “one size fits all” solution, the proposed rule would allow providers to get one step closer to meeting patients where they are. The flexibility allowed in the proposed rule would provide qualifying practitioners with the flexibility to provide patient care with safeguards to protect both themselves and their patients. However, even with safeguards the concern of physicians overprescribing could be a potential drawback that could lead open the door to a flood of litigation or substance abuse.