The unprecedented public health emergency created by the novel coronavirus disease (COVID-19) has sparked action by state and federal regulators to ensure greater access to care, while simultaneously limiting the spread of COVID-19.
Federal agencies have made four key announcements as part of a national effort to increase access to controlled substances and treatment, in response to the current pandemic and in preparation for future national healthcare needs.
- Exceptions to the Ryan Haight Online Pharmacy Consumer Protection. Generally, under the U.S. Controlled Substances Act (21 U.S.C. 829(e)) (“Controlled Substances Act”), a practitioner could only prescribe controlled substances (including e-prescriptions issued via telemedicine) to an individual after the practitioner conducted an in-person evaluation of such individual. Therefore, if a practitioner only had a telehealth relationship with an individual, the practitioner could not prescribe a controlled substance to such individual. However, one exception to the Controlled Substances Act occurs when the Secretary of the U.S. Department of Health and Human Services (“HHS”) declares a public health emergency.
The Secretary of HHS declared the COVID-19 outbreak a public health emergency on Jan. 31, 2020, which triggered the DEA Administrator to declare that practitioners may issue prescriptions for controlled substances to patients via telemedicine, even for patients for whom they have not conducted an in-person medical evaluation, provided:
- The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice;
- The telemedicine communication is conducted using an audiovisual, real-time, two-way interactive communication system; and
- The practitioner is acting in accordance with applicable federal and state laws.
- The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice;
- Waivers for In-Person Testing Requirements for High-Risk Medications. In light of the COVID-19 emergency, the FDA issued guidance indicating that it will temporarily allow healthcare practitioners who dispense certain high-risk, controlled medications, subject to risk evaluation and mitigation strategies (REMS) requirements, to dispense such drugs without requiring patients to come in for laboratory testing or imaging studies, such as an MRI, which are usually prerequisites for treatment. The FDA’s guidance provides that the agency does not intend to take enforcement action against doctors or pharmacists who do so, provided that the decision to waive laboratory testing requirements was based on the judgment of the healthcare provider.
- Early Fills of Controlled Substances. On March 20, in a letter to DEA registrants, the DEA reiterated the permissibility of writing controlled substance prescriptions to cover a 90-day supply, either by issuing a single 90-day supply prescription, or by issuing three 30-day prescriptions to be filled consecutively, provided it is permissible under state law. The practitioner can sign and date each script under a single date issued and write on each prescription the earliest date it may be filled.
The ability of a pharmacy to provide early dispensation of a controlled substance is dictated by state law, to the extent the state requirement is more stringent than the federal requirement. State laws may have changed in light of the COVID-19 pandemic, and it is important for each pharmacy, pharmacist and registered healthcare practitioner to be familiar with state laws.
- Out-of-State Prescribers of Controlled Substances. On March 25, the DEA sent a letter to all registrants informing them that, for the duration of the COVID-19 public health emergency, only one DEA registration would be required under federal law to dispense controlled substances in multiple states. Under normal circumstances, the DEA permitted a practitioner to prescribe controlled substances only in the state in which he or she is licensed to practice, requiring a practitioner to obtain a separate DEA registration in each state in which he or she dispenses controlled substances. The DEA will now grant an exception to practitioners who practice in multiple states for the duration of the public health emergency.
Multiple states have also declared states of emergency and have granted some level of reciprocity to prescribers in other states. Practitioners in these states must still be registered in their home state, and must have permission under state law in each state where they practice to dispense controlled substances, despite the new allowance under federal law. Again, it remains incumbent upon practitioners to review the state laws of any state into which they intend to prescribe.
McGuireWoods has a dedicated team of specialists that will continue to monitor state and federal responses to COVID-19. Please contact the authors of this alert with any questions and for additional guidance on how other COVID-19 considerations may impact prescriptions and drugs. McGuireWoods has published additional thought leadership related to how companies across various industries can address crucial COVID-19-related business and legal issues.