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COVID-19: DEA Confirms Public Health Emergency Exception for Telemedicine Prescribing of Controlled Substances

With the rapid spread of the novel coronavirus (COVID-19) pandemic and the looming possibility of large scale isolations and quarantines, lawmakers continue to demonstrate willingness to expand access to telehealth to combat this public health crisis. This is particularly important in the current environment of a highly contagious infectious disease like COVID-19, where requiring patients to physically visit their practitioner’s office to receive needed medication could result in patient (or health care practitioner) harm. For example, a patient could unknowingly expose other patients and health care practitioners to the coronavirus, or a patient could miss out on life-saving medication if the patient is too sick to leave their home and travel to their physician’s office for assessment and treatment.

On March 16, 2020, the Drug Enforcement Agency (DEA) published a COVID-19 Information Page on the Diversion Control Division website, providing guidance relating to the COVID-19 public health emergency, including the ability to prescribe controlled substances via telemedicine without a prior in-person exam. This public health emergency exemption is one of seven exceptions to the federal Ryan Haight Act’s requirement to conduct an in-person exam before prescribing controlled substances via telemedicine.

What is the Federal Ryan Haight Act?

Enacted over a decade ago, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 amended the federal Controlled Substances Act, and imposed a federal prohibition on form-only online prescribing for controlled substances. Under the Ryan Haight Act, a practitioner cannot issue a “valid prescription” for a controlled substance by means of the Internet (which, for all practical purposes, includes telemedicine technologies) without having first conducted at least one in-person medical evaluation, except in certain specified circumstances.

What Are the Key Aspects of the Public Health Emergency Exception?

The Act offers seven exceptions to the in-person exam requirement for practitioners engaged in the “practice of telemedicine.” One such exception occurs when the Secretary of the U.S. Department of Health and Human Services (HHS) has declared a public health emergency and “involves patients located in such areas, and such controlled substances, as the Secretary of Health and Human Services, with the concurrence of the Administrator, designates.” Secretary Azar declared such public health emergency with regard to COVID-19 on January 31, 2020. Note, as of March 17, we have not seen a formulary or announcement made by the HHS Secretary designating the controlled substances under this exception.

According to the DEA website, for as long as the Secretary’s designation of a public health emergency remains in effect, DEA-registered practitioners may issue prescriptions for controlled substances to patients without first conducting an in-person medical evaluation, provided all of the following conditions are met:

  • 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 audio-visual, real-time, two-way interactive communication system.

  • The practitioner is acting in accordance with applicable Federal and State law.

Provided the practitioner satisfies the above requirements, the practitioner may issue the prescription using any of the methods of prescribing currently available and in the manner set forth in the DEA regulations. Thus, the practitioner may issue a prescription either electronically (for schedules II-V drugs) or by calling in an emergency schedule II prescription to the pharmacy, or by calling in a schedule III-V prescription to the pharmacy.

Note that if the prescribing practitioner has previously conducted an in-person medical evaluation of the patient, the practitioner may issue a prescription for a controlled substance after having communicated with the patient via telemedicine, or any other means, regardless of whether a public health emergency has been declared by the Secretary of HHS, so long as the prescription is issued for a legitimate medical purpose and the practitioner is acting in the usual course of his/her professional practice.

What About State Laws on Telemedicine and Controlled Substances?

Even with the public health emergency exception, practitioners must comply with both federal and state laws. Some states prohibit the prescribing of controlled substances via telemedicine, some allow it with restrictions (e.g., only for treatment of psychiatric disorders, or prohibit the use for treatment of chronic nonmalignant pain, etc.), whereas other states broadly allow it. Additionally, states may announce similar public health emergency exceptions at a state-by-state level. In any event, the federal and state laws must be read in harmony with each other.

Regardless of the language of state law, whether the exam is conducted in-person or via the practice of telemedicine, a prescription for a controlled substance must always be issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice.

© 2020 Foley & Lardner LLP

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About this Author

Thomas B. Ferrante, Foley, Healthcare Regulatory Lawyer, Transactional Matters Attorney
Senior Counsel

Thomas (T.J.) Ferrante is an associate and health care lawyer with Foley & Lardner LLP, where he focuses his practice on a wide range of transactional and related regulatory issues for health industry clients, including for-profit and not-for-profit hospitals and health systems, multi-specialty physician practice groups, and long-term care providers. Mr. Ferrante has experience with a variety of transactions, including mergers and acquisitions, joint ventures, strategic affiliations, obtaining and maintaining tax-exemption, employment contracts and leases, and other...

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Sunny Levine Health Care Lawyer Foley Lardner
Associate

Sunny J. Levine is a health care lawyer with Foley & Lardner LLP, and member of the firm’s Telemedicine & Digital Health and Health Care Industry Teams working with hospitals and health systems, physician practice groups, and technology companies across the country. Sunny’s practice focuses on federal and state regulatory compliance and business issues in the health care industry. She also works with companies offering highly regulated consumer products, such as medical marijuana and alcohol beverages.

Telemedicine & Digital Health Experience

Sunny’s practice includes regulatory compliance issues associated with telemedicine and digital health, and health innovation. She helps companies navigate state and federal laws and regulations governing telemedicine and digital health for multi-state footprints, including state corporate practice of medicine restrictions, forming a valid provider-patient relationship, licensure requirements, telemedicine prescribing, and informed consent.

Selected, representative matters include:

  • Asynch Direct to Consumer: Advised a start-up company providing nationwide telehealth services through a direct-to-consumer, asynchronous (store & forward) telemedicine platform. Drafted suite of operational contracts and documents for company, including professional service agreements, privacy agreements, technology agreements, and patient-facing materials. Provided guidance on state-specific laws and regulations on prescribing weight loss and lifestyle medications via telemedicine
  • Digital Ocular Health: Advised ophthalmology and optometry groups on federal and state vision laws, including co-location requirements and fraud abuse issues
  • Telemedicine Legislative Tracking: Advised an academic medical center on pending or newly enacted telemedicine laws, regulations, and regulating board policies throughout the U.S., and U.S. territories (Guam, Puerto Rico)
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