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DEA: In-Person Visit Not Required For Controlled Substances Prescription During Public Health Emergency

The US Drug Enforcement Administration (DEA) stated in an FAQ on its website that prescribers may issue prescriptions for controlled substances based on a telemedicine encounter in the absence of an in-person medical evaluation for the duration of the COVID-19 public health emergency. This alert reviews the FAQ and the state level barriers that remain for the exception.

IN DEPTH


The US Drug Enforcement Administration (DEA) stated in an FAQ on its website that for the duration of the public health emergency declared by US Department of Health and Human Services (HHS) Secretary Alex M. Azar with regard to COVID-19, prescribers may issue prescriptions for controlled substances based on a telemedicine encounter in the absence of an in-person medical evaluation. This development could remove a significant barrier to the use of telemedicine in the treatment of patients affected by the COVID-19 outbreak and other vulnerable populations. State barriers to such practice may still exist, however, and the full effect of the exception may require certain state governments to follow suit.

Background

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires a telemedicine provider to perform an in-person medical evaluation of a patient prior to prescribing a controlled substance to that patient, unless an exception applies. As noted in the DEA FAQ, one such exception occurs when the secretary of HHS has declared a public health emergency (Public Health Emergency Exception), such as the declaration by Secretary Azar with regard to COVID-19 on January 31, 2020, with retroactive effect to January 27, 2020.

The DEA FAQ states that as a result of the declaration, DEA-registered practitioners may issue prescriptions for controlled substances to 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 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.

The DEA FAQ generally aligns with the requirements of the Ryan Haight Act. However, the text of the Public Health Emergency Exception includes a second prong that limits the application of the exception to “patients located in such areas, and such controlled substances, as the Secretary, with the concurrence of the Attorney General, designates.” This prong implies that some sort of designation by Secretary Azar with the concurrence of the attorney general would be required for the exception to have effect. While the exception likely will not be limited in geographic scope, given that a public health emergency has been declared nationwide, we have not seen any communications from HHS or the attorney general addressing the use of the exception or the scope of acceptable controlled substances.

Don’t Forget State Law

While the Ryan Haight Act is often the focus of telemedicine remote prescribing compliance, in reality remote prescribing regulation is largely left to the states. Remote prescribing restrictions can be commonly found in telemedicine-specific statutes or regulations, pharmacy practice acts, medical practice acts, and in controlled substances acts themselves. Some states still require a face-to-face encounter prior to prescribing controlled substances to treat a patient. As a result, the scope of the exception could be limited within a particular state by the application of state laws that are more stringent than the exception with respect to the prescription of controlled substances based on a telemedicine encounter.

While some states have relaxed prohibitions against prescribing controlled substances based on a telemedicine encounter, others have limited the practice to patients in certain treatment facilities or with certain conditions, such as substance abuse disorders. States may also continue to enforce additional restrictions on prescribers, particularly with respect to cross-border practices, including limitations with respect to the licensure or registration of prescribers qualified to prescribe controlled substances.

Certain recent COVID-19 state emergency declarations may loosen state remote prescribing requirements. For example, the Mississippi State Board of Medical Licensure issued a proclamation on March 14, 2020, stating that the board will not enforce any statute, rule or regulation that requires physicians to personally examine patients before issuing a prescription, including controlled substances.

Before changing current telemedicine prescribing practices based on the DEA FAQ, prescribers should review any state law restrictions on prescribing controlled substances to patients seen via telemedicine without a prior physical examination.

© 2020 McDermott Will & Emery

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About this Author

Amanda Enyeart Healthcare and Life Sciences Attorney Mcdermott WIll Emery Law Firm
Partner

Amanda Enyeart is an associate in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office.  Amanda focuses her practice on general regulatory health law matters. 

Previously, Amanda was an associate at a national law firm in its Chicago office where she provided guidance on regulatory issues, such as practitioner licensure; telehealth; Medicare and Medicaid reimbursement; and compliance with Stark Law and the Anti-Kickback Statute and state fraud and abuse laws.

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Marshall E. Jackson, Jr. Partner  Washington, DC Regulatory, Government & Lobbying Strategies  Healthcare  Digital Health
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Marshall E. Jackson, Jr. focuses his practice on transactional and regulatory counseling for clients in the healthcare industry, as well as advises clients on the legal, regulatory and compliance aspects of digital health.

 

Health Transactions and Regulatory Compliance

Marshall provides counseling and advice to hospitals and health systems, private equity firms and their portfolio companies, post/sub-acute providers, physician practices, and other public and private healthcare companies in a variety of complex transactions and health regulatory compliance matters. Marshall assists clients in all aspects of healthcare transactions, including mergers, acquisitions, joint ventures and strategic affiliations. Marshall focuses his regulatory practice on advising clients with respect to federal and state healthcare fraud and abuse compliance, reimbursement issues, behavioral and mental health regulatory compliance, licensure, and operational matters.

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Marshall advises healthcare providers, private equity firms and their portfolio companies, and technology companies involved in “digital health” – the intersection of health software applications, analytical tools, medical technology and electronic data assets enabled by the Internet and mobile devices –on a variety of legal, regulatory and compliance matters with a particular focus on digital health topics, including telehealth, telemedicine, mobile health and consumer wellness. Such engagements include assisting clients in developing and implementing telehealth programs by advising on issues related to professional licensure, scope of practice, informed consent, prescribing and reimbursement.

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Lisa Schmitz Mazur, Health Law Attorney, McDermott Will Law Firm
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Lisa Schmitz Mazur is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office.  Lisa maintains a general health industry practice, focusing on the representation of hospitals and health systems and other health industry providers.

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