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Telemedicine Prescribing and Controlled Substances Laws

Nathaniel Lacktman, Esq.
Healthcare Partner, Foley & Lardner, LLP, Tampa, FL

As providers become more comfortable with delivering care via telemedicine, telehealth and digital health technologies, some are exploring services beyond low acuity consults. One area of opportunity and notable confusion is prescribing controlled substances via telemedicine. This particularly affects specialties that couple chronic disease management with pharmacotherapy, for example, adolescent and adult telepsychiatry, substance abuse/recovery, endocrinology, hormone replacement therapy and medical weight loss.

Providers are increasingly inquiring about telemedicine prescribing laws and rules, as well as strategies and approaches for business models and service lines that not only satisfy patient needs, but comply with the layers of intersecting state and federal laws on telemedicine, medical practice, fraud and abuse and controlled substances. Indeed, telemedicine prescribing of controlled substances was one of the Telehealth Top 10 for 2015 and has only continued to generate interest since that time.

What is the Federal Ryan Haight Act?

The Ryan Haight Online Pharmacy Consumer Protection Act was designed to combat the rogue internet pharmacies that proliferated in the late 1990s, selling controlled substances online. The Act took effect April 13, 2009 and the Drug Enforcement Agency (DEA) issued regulations effective that same date. The Act essentially imposed a federal prohibition on form-only online prescribing for controlled substances. Although the Act was intended to target “rogue” internet pharmacies, legitimate healthcare providers who prescribe controlled substances via telemedicine must carefully review the regulations to ensure compliance.

Exceptions for the Practice of Telemedicine Under the Ryan Haight Act

The Act contains the following “practice of telemedicine” exceptions:

  1. Treatment in a hospital or clinic. The practice of telemedicine is being conducted while the patient is being treated by, and physically located in, a hospital or clinic registered under section 303(f) of the Act (21 U.S.C. 823(f)) by a practitioner acting in the usual course of professional practice, who is acting in accordance with applicable state law, and who is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in the state in which the patient is located, unless the practitioner:
    • Is exempted from such registration in all states under section 302(d) of the Act (21 U.S.C. 822(d); or
    • Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract, and registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any state or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f);
  2. Treatment in the physical presence of a practitioner. The practice of telemedicine is being conducted while the patient is being treated by, and in the physical presence of, a practitioner acting in the usual course of professional practice, who is acting in accordance with applicable state law, and who is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in the state in which the patient is located, unless the practitioner:
    • Is exempted from such registration in all states under section 302(d) of the Act (21 U.S.C. 822(d)); or
    • Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract, and registered under section 303(f) of the Act (21U.S.C. 823(f)) in any state or is using the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f);
  3. Indian Health Service or tribal organization. The practice of telemedicine is being conducted by a practitioner who is an employee or contractor of the Indian Health Service, or is working for an Indian tribe or tribal organization under its contract or compact with the Indian Health Service under the Indian Self-Determination and Education Assistance Act; who is acting within the scope of the employment, contract, or compact; and who is designated as an Internet Eligible Controlled Substances Provider by the Secretary of Health and Human Services under section 311(g)(2) of the Act (21 U.S.C. 831(g)(2));
  4. Public health emergency declared by the Secretary of Health and Human Services. The practice of telemedicine is being conducted during a public health emergency declared by the Secretary of Health and Human Services under Section 319 of the Public Health Service Act (42 U.S.C. 247d), 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, provided that such designation shall not be subject to the procedures prescribed by the Administrative Procedure Act (5 U.S.C. 551–559 and 701–706);
  5. Special registration. The practice of telemedicine is being conducted by a practitioner who has obtained from the Administrator, a special registration under Section 311(h) of the Act (21 U.S.C. 831(h));
  6. Department of Veterans Affairs medical emergency. The practice of telemedicine is being conducted:
    • In a medical emergency situation:
      • That prevents the patient from being in the physical presence of a practitioner registered under Section 303(f) of the Act (21 U.S.C. 823(f)) who is an employee or contractor of the Veterans Health Administration acting in the usual course of business and employment and within the scope of the official duties or contract of that employee or contractor;
      • That prevents the patient from being physically present at a hospital or clinic operated by the Department of Veterans Affairs registered under Section 303(f) of the Act (21 U.S.C. 823(f));
      • During which the primary care practitioner of the patient or a practitioner otherwise practicing telemedicine within the meaning of this paragraph is unable to provide care or consultation; and
      • That requires immediate intervention by a healthcare practitioner using controlled substances to prevent what the practitioner reasonably believes in good faith will be imminent and serious clinical consequences, such as further injury or death; and
    • By a practitioner that:
      • Is an employee or contractor of the Veterans Health Administration acting within the scope of that employment or contract;
      • Is registered under Section 303(f) of the Act (21 U.S.C. 823(f)) in any state, or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under Section 303(f); and
      • Issues a controlled substance prescription in this emergency context that is limited to a maximum of a five-day supply which may not be extended or refilled; or
  7. Other circumstances specified by regulation. The practice of telemedicine is being conducted under any other circumstances that the Administrator and the Secretary of Health and Human Services have jointly, by regulation, determined to be consistent with effective controls against diversion and otherwise consistent with the public health and safety.

What Does the Ryan Haight Act Mean for Healthcare Professionals?

Under the Ryan Haight Act, no controlled substance may be delivered, distributed or dispensed by means of the internet (which, for all practical purposes, includes telemedicine technologies) without a valid prescription. A valid prescription is one that is issued for a legitimate medical purpose in the usual course of professional practice by: 1) a practitioner who has conducted at least one in-person medical evaluation of the patient; or 2) a covering practitioner. An “in-person medical evaluation” means a medical evaluation that is conducted with the patient in the physical presence of the prescribing practitioner, without regard to whether portions of the evaluation are conducted by other health professionals.

While the DEA has historically viewed the lack of an in-person medical evaluation as a red flag of potential drug diversion, the Ryan Haight Act makes it unambiguous that it is a per se violation of the Federal Controlled Substances Act for a practitioner to issue a prescription for a controlled substance by means of the internet without having conducted at least one in-person medical evaluation, except in certain specified circumstances. Once the prescribing practitioner has conducted an in-person medical evaluation, the Ryan Haight Act does not set an expiration period or a mandatory requirement of subsequent annual re-examinations (although specific controlled substances, such as Suboxone, may have their own rules). Of course, this does not mean that conducting one in-person medical evaluation is sufficient in every clinical situation. Even where the practitioner has conducted an in person exam, a prescription for a controlled substance must still be issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice.

Can a Healthcare Provider Prescribe Controlled Substances via Telemedicine?

The Ryan Haight Act does not prohibit the use of telemedicine to prescribe controlled substances, and a provider may do so if federal and state requirements are met. However, the challenge for many providers is understanding these laws and applying them to the processes of their specific service line or business. There are solutions and approaches that can work for primary care practices, hospitals, telepsychiatry groups and the like. Moreover, the Ryan Haight Act has seven exceptions to the in-person medical evaluation requirement for when a prescriber is engaged in the practice of telemedicine. For DEA purposes, keep in mind that “practice of telemedicine” is a defined term of art, and the exceptions are technical and specific. Providers should not assume their approach to telemedicine or virtual care does, in fact, meet a “practice of telemedicine” exception under the Ryan Haight Act.

What’s Next for the Ryan Haight Act?

In 2015, the American Telemedicine Association (ATA) sent a letter to the DEA, advocating for provider-friendly changes to federal controlled substance prescribing rules. Disclosure: attorneys in Foley’s telemedicine practice were contributing authors to the letter. The letter urged DEA to open a special registration process allowing psychiatrists and physicians to prescribe controlled substances via telemedicine without the need for an in-person exam. The ATA letter noted that “the interpretation of the Ryan Haight Act ’s general prohibition of prescribing controlled substances by means of the internet has become overly restrictive.”

In 2016, DEA announced plans to issue a new rule to activate the special registration process allowing physicians to use telemedicine to prescribe controlled substances without an in-person exam. The most recent notice of rulemaking stated the proposed rule was expected to be published in January 2017. As of this article, the proposed rule has not yet been released, but is anticipated to be published this year.


Nathaniel Lacktman, Esq., is a healthcare lawyer and partner with Foley & Lardner, LLP. His primary practice area is telemedicine and telehealth, advising a range of clients, including hospitals, clinics, physicians and entrepreneurs, on the opportunities, business models and regulatory issues presented by innovative healthcare delivery approaches and disruptive technologies. A true believer in healthcare innovation, he advises clients on telehealth issues nationwide and internationally with a particular focus on U.S. to China telemedicine arrangements. He earned his law degree from the University of Southern California School of Law. He may be reached at This email address is being protected from spambots. You need JavaScript enabled to view it. or www.foley.com/telemedicine.


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