By Kaytie Ravega, partner at Quarles & Brady LLP, with contributions from partner Ted Sullivan and associates Ashleigh Giovannini, Shamika Mazyck, Jacob Pallotta, and Monica Wright, who thankfully watched the DEA listening sessions referenced below in shifts to capture the threads and important points raised by the many speakers on this critical topic.

Introduction to federal law regulating telemedicine controlled substance prescribing, circa 2009 through 2020

It is well known that the Drug Enforcement Administration (“DEA”) requires a prior in-person visit before a healthcare provider may prescribe a controlled substance to a patient during a telemedicine encounter.  This is a component of the Ryan Haight Act (the “Act”), a federal statute that took effect in 2009. Perhaps less familiar, the Act also includes a mandate to DEA to create a way for telemedicine providers to register or have some path to providing controlled substance prescriptions to their patients without the in-person visit requirement.  Developing a registration for telemedicine providers has apparently not been as easy as creating a separate registration number, such as the recently-retired “X” numbers for suboxone prescribing.  Rather, despite multiple instructions from Congress over the past decade, as well as pleas from industry leaders such as the American Hospital Association, DEA has not implemented an option for telemedicine providers to provide care for patients who require controlled substance prescriptions without the in-person visit.  The most recent Covid-19 public health emergency (“PHE”), however, continued to force the issue.

Attempts at regulating telemedicine controlled substance prescribing, circa 2023

During the PHE the in-person visit requirement for telehealth controlled substance prescribing was generally waived, with an express statement from DEA that the requirement would be restored once the pandemic ended. As the PHE rambled toward closure, on February 24, 2023 the Department of Health and Human Services (“HHS”), the Department of Veterans Affairs (“VA”), and DEA issued a Notice of Proposed Rulemaking (the “Proposed Rule”) proposing to permanently extend the PHE telemedicine prescribing flexibilities and requesting public comments on the proposal.  

In May 2023, the DEA published an alert indicating that it received more than 38,000 comments from industry stakeholders regarding the Proposed Rule. Because of this comment volume, the DEA announced the submission of a draft Temporary Rule to the Office of Management and Budget titled “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” (the “Temporary Rule”) with an effective date of May 11,^,2023. The Temporary Rule authorized providers to continue relying on the PHE telemedicine flexibilities for the prescription of controlled substances through November 11, 2023. Upon that expiration date, the Temporary Rule had stated that the full scope of telemedicine flexibilities will end for new relationships, and only be extended through November 11, 2024 for provider-patient telemedicine relationships established prior to or on November 11, 2023. 

As part of the planning for the Proposed Rule to become effective (once the Temporary Rule ended or at some other time to be determined) and to consider what additional changes may be needed in light of all the comments to the Proposed Rule, DEA hosted a two-day listening session on September 12 and 13, 2023 to empower “healthcare practitioners, experts, advocates, patients, and other members of the public” to voice their support for or objection to the provisions of the Proposed Rule. The stated goal of the listening session was to “receive additional input concerning the practice of telemedicine with regards to controlled substances and potential safeguards that could effectively prevent and detect diversion of controlled substances via telemedicine.”  In other words, DEA and the healthcare community at large face a challenge of competing interests in terms of telemedicine prescribing; specifically, how to support increased access to healthcare through telemedicine while managing the risk of diversion? 

Numerous presenters over the course of the two day event addressed a range of topics related to telemedicine prescribing, discussing:

• the need for more flexibility, away from the rigidity of the pre-PHE prior in-person visit requirement;
• concerns about ensuring prescriptions are valid and that provider-patient relationships exist;
• ensuring that pharmacies are not treated as a gatekeeping substitute for adequate enforcement against rogue prescribers;
• preventing telemedicine from being an avenue of diversion or fraud to the extent possible; 
• the critical role of telemedicine in access to care in multiple scenarios where many parts of the U.S. confront provider shortages, including mental health care, behavioral health, and chronic condition management of many kinds; 
• telemedicine’s effect on patient compliance with care and improved participation in care management, such as showing up for telemedicine visits more reliably and other key examples; 
• a wide range of proposals for recommended changes, including those who requested prohibiting some specific products or provider types, such as nurse practitioners and physician assistants, from controlled substance prescribing via telemedicine altogether; and
• whether DEA has a legitimate role in affecting telemedicine practice to the extent clinical care is affected, among many other points both for and against these examples.

In the face of all of this, to consider options and next steps, DEA again adjusted the compliant path.

The Current Rule, circa 2023-2024

Approximately a month after the listening sessions, on October 10, 2023, DEA, jointly with HHS, published a “Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications,” (the “Current Rule”).  Note that state requirements may vary from and be more stringent than DEA’s requirements.

The Current Rule extended and renewed the Temporary Rule, meaning that instead of ending on November 11, 2023, the flexibilities for controlled substance prescribing in place during the PHE are now extended through December 31, 2024. Further, the Current Rule authorizes all DEA-registered practitioners to prescribe Schedule II-V controlled substances via telemedicine until December 31, 2024, regardless of whether the practitioner established a telemedicine relationship with the patient prior to or on November 11, 2023. The DEA signaled that the agency chose to extend these flexibilities as it continues to evaluate the information gathered during the two-day listening session and develop new standards and/or safeguards for telemedicine prescribing of controlled medications. Drafters of the Current Rule indicated that DEA anticipates promulgating new rules in the Fall of 2024. 

Specifically, under the Current Rule, and if allowed by applicable state laws, controlled substance prescriptions may be issued during a telemedicine encounter, without a prior in-person visit, only if all of the following conditions are met: 

(1) The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice; 

(2) The prescription is issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system referred to in 42 CFR § 410.78(a)(3) [a two way, audio video real time encounter];

(3) The practitioner is (i) authorized to prescribe the class of controlled substance specified on the prescription, or (ii) exempt from obtaining a registration to dispense controlled substances; and

(4) The prescription is consistent with all other applicable legal requirements.

See 21 CFR § 1307.41; 42 CFR § 12.1.

By: Samantha Hollinshead, J.D. Candidate, Sandra Day O’Connor College of Law, Arizona State University, and

Jennifer L. Piatt, J.D., Co-Director, Center for Public Health Law and Policy, Sandra Day O’Connor College of Law, Arizona State University

Sexual education has historically focused on disease and pregnancy prevention. In 2009, the United Nations (UN) moved towards a more holistic approach, defining “comprehensive sexual education” (CSE) as (1) “scientifically accurate,” (2) “incremental,” (3) “age-and developmentally appropriate,” (4) “curriculum based,” (5) “comprehensive,”[i] (6) “based on a human rights approach,” (7) “based on gender equality,” (8) “culturally relevant and context appropriate,” (9) “transformative,”[ii] and (10) focused towards development of life skills needed to “support healthy choices.”

Extensive research has indicated that CSE is generally effective in producing positive public health outcomes such as reducing teen pregnancy and HIV rates. CSE is most effective when educators provide accurate information on a range of topics, empowering students to take ownership of their physical and emotional development. Deliberately excluding critical aspects of sexual education, including menstruation, gender identity, and sexual orientation, reduces its overall efficacy, contributes to misinformation, and leads to greater risk-taking, precipitating broader public health implications.

CSE has not been uniformly adopted in the U.S. despite the U.S. having the highest rates of teen pregnancy among industrialized countries, per various studies conducted over the past several decades.[iii] Current law and policy approaches to sexual education in the U.S. resemble a checkerboard of state requirements that do not reflect the UN’s CSE guidance. As described below, the health of American populations may benefit extensively from domestic implementation of CSE programs as compared to other nations. Yet, profound political, social, and legal complications toward this realization exist across multiple U.S. jurisdictions on three key CSE determinants: (1) age limitations; (2) abstinence-only education; and (3) LGBTQ+ inclusivity.

Age and Informational Limitations

Even though providing broad and accurate information makes CSE more effective, some U.S. states are continuing to pass legislation or operate programs that directly limit access to sexual education. Florida’s House Bill 1069, signed by Governor Ron DeSantis in May 2023, expressly restricts health education, including discussions on puberty, to students in 6^th – 12^th grades. The average age individuals assigned female at birth start their periods is just over 12 years, but some start as early as 8 years. By limiting the age at which health education is taught, individuals assigned female at birth may lack vital information until after they have already begun menstruating. Poor period hygiene can result in the spreading of diseases (e.g., bacterial vaginosis, urinary tract infections, hepatitis B) and long-term reproductive issues, including complications during birth and infertility.

Comparatively, in the Netherlands, CSE starts as young as 4 years of age. Students receive education about their physical development, ways to prevent adverse health outcomes, body image, and healthy relationships, among other topics. Consequently, Dutch teen pregnancy and HIV  infection rates in 2021 were among the lowest in the world among industrialized countries, due partly to incorporating CSE principles into the curriculum at a young age.

Approaches to Combat Misinformation

Abstinence-only sexual education has been proven ineffective in diminishing risky behaviors and contributes to misinformation rooted in stigma and fear-based tactics. Still, according to the Guttmacher Institute, educators in 29 U.S. states, including Arizona, are required to stress the importance of abstinence in sexual education. In 2011, Zambia introduced components of CSE to address the spread of misinformation extending from students receiving inaccurate and outdated guidance online or from family members. Consequently, Zambian health authorities measured a roughly 7% decrease in unintended pregnancies from 2010 and 2019 and a 50% drop in new HIV  infections between 2011 and 2021. Zambia’s program, though, lacks inclusivity of LGBTQ+ individuals, so still does not fully meet the UN’s definition of CSE.

LGBTQ+ Inclusivity

Currently, only eleven U.S. states require sexual education curricula to address sexual orientation inclusively. In fact, Florida, Kentucky, and Louisiana, among other states, have legislatively banned discussions on gender identity or sexual orientation in schools. While some states have not outright banned inclusive sex education, states such as North Carolina require educators to emphasize monogamous heterosexual marriages. Limiting LGBTQ+ students’ access to relevant sexual education further entrenches social stigma and discrimination lending to significant health related repercussions, including sexual violence and unintended pregnancies. Importantly, some states have recently moved in more inclusive directions. In 2019, Arizona eliminated an educational requirement to “promote honor and respect for monogamous heterosexual marriage.”

Estonia was the first post-Soviet Union country to introduce comprehensive sexual education in schools and currently implements a highly regarded CSE program. Estonia’s CSE curriculum, introduced in 1996, was updated in 2011 to include LGBTQ+ individuals. Estonia has experienced a marked  improvement in sexual health indicators since its adoption of CSE, with abortions falling by 37%, sexually-transmitted infections by 55%, and HIV-specific infections by a whopping 89% from 2001 to 2009. 

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International comparisons illustrate the significant public health benefits of CSE among school-age children. Timely, adaptive, accurate, and meaningful sexual education reinforces their physical and mental well-being and helps ensure students can make informed and responsible decisions. While there are myriad legal and political reasons why CSE is not adopted more broadly across the U.S., its uniform implementation could provide similar benefits for American school students burdened with the negative public health consequences of inadequate sexual education.  

The legal information and assistance provided in this document do not constitute legal advice or legal representation. Views expressed in this piece are those of the authors alone.

[i] UNESCO, International Technical Guidance on Sexuality Education (2018), https://unesdoc.unesco.org/ark:/48223/pf0000260770 (finding an educational program comprehensive if it addresses a wide range of sexual and reproductive issues including anatomy, physiology, reproduction, puberty, contraception, menstruation, childbirth, and STIs).

[ii] Id. (defining educational programs as transformative if they encourage development of critical thinking skills and healthy attitudes towards sexual and reproductive health in an effort to foster compassionate citizens).

[iii]Gilda Sedgh et al., Adolescent Pregnancy, Birth, and Abortion Rates Across Countries: Levels and Recent Trends, 56 J. Adolescent Health 223 (2015), https://www.sciencedirect.com/science/article/pii/S1054139X14003875?via%3Dihub;Susheela Singh and  Jacqueline E. Darroch, Adolescent Pregnancy and Childbearing: Levels and Trends in Developed Countries, 32 Fam. Plan. Persp. 14 (2000), https://www-jstor-org.ezproxy1.lib.asu.edu/stable/2648144?origin=crossref.

By: Nikki Hazelett, 2025 J.D. Candidate, Sandra Day O’Connor College of Law at Arizona State University

In early spring, the Drug Enforcement Agency (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) issued a temporary regulation that extended specific telemedicine flexibilities that were initially implemented during the federal COVID-19 Public Health Emergency (PHE).

Per this extension, the DEA’s full set of COVID-19 waivers for prescribing controlled substances via telemedicine will remain viable until November 11, 2023. Provided such prescriptions comply with DEA regulations, physicians may continue to prescribe schedule II-V controlled medications through telemedicine without first conducting an in-person medical examination of the patient.

Additionally, the extension grants individuals who formed a practitioner-patient relationship via telemedicine on or before November 11, 2023, a one-year grace period through November 11, 2024, to continue utilizing PHE flexibilities for prescribing controlled medications through telemedicine.

The intended goal of the temporary extension is to prevent lapses in patient care, ensure the accessibility of telemedicine, and allow sufficient time for healthcare practitioners and patients to prepare for future regulations regarding prescribing controlled medications via telemedicine.

Ultimately, the DEA and SAMHSA anticipate enacting a final set of regulations concerning the practice of telemedicine. Until then, the federal government has determined this temporary regulation is “otherwise consistent with public health and safety,” allowing the DEA and Department of Health and Human Services (HHS) time to address the 38,396 public comments received on two previous notices of proposed rulemakings concerning telemedicine.

Legal Authority & Background:

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act) amended the Controlled Substances Act by adding several new provisions regarding the illegal distribution of controlled substances over the internet. The Ryan Haight Act prohibits distributing and delivering controlled substances online without a valid prescription.[1] The Ryan Haight Act aimed to deter the exploitation of controlled substances through “rouge websites” and “online pharmacies” offering medications without a valid physician-patient relationship.

Implemented by the DEA, the Ryan Haight Act requires practitioners to perform in-person medical evaluations before prescribing controlled medications to patients via telemedicine. It also established seven “practice of telemedicine” exceptions, one of which authorizes the Attorney General and Secretary of Health and Human Services to promulgate rules allowing practitioners to prescribe controlled medications without conducting an in-person examination, provided the practice is in accordance with Federal and State law.

DEA & HHS Proposals:

In response to the COVID-19 PHE, the DEA granted temporary exceptions to both the Ryan Haight Act and the DEA’s power to implement regulations, which permitted physicians to prescribe controlled medications through telemedicine without a prior in-person medical examination. 

The DEA put forth these regulations via two published letters in 2020:

• A March 25, 2020 “Dear Registrant” letter signed by William T. McDermott, DEA’s then-Assistant Administrator, Diversion Control Division; and
• A March 31, 2020 “Dear Registrant” letter signed by Thomas W. Prevoznik, DEA’s then-Deputy Assistant Administrator, Diversion Control Division. 

Three years later, faced with the impending expiration of the COVID-19 PHE, the DEA and HHS promulgated two notices of proposed rulemakings (NPRMs) on March 1, 2023:

• “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation” (the General Telemedicine Rule); and
• “Expansion of Induction of Buprenorphine via Telemedicine Encounter” (the Buprenorphine Rule). 

The proposed rules would establish limited circumstances where a practitioner may prescribe specific controlled medications to patients through telemedicine post-PHE. The agencies expressed a desire to transition seamlessly into post-PHE regulations and ensure patients have reliable access to controlled prescriptions via telemedicine consistent with “public health and safety, while maintaining effective controls against [drug] diversion.”

For example, the General Telemedicine Rule proposed a grace period of 180 days after the expiration of the COVID-19 PHE to extend telemedicine flexibilities to practitioner-patient relationships formed during COVID-19. 

The comment period for the proposed rules ran through March 31, 2023, and generated an astonishing 38,369 public comments. To effectively review these comments, the DEA and SAMHSA issued a temporary extension of PHE telemedicine flexibilities, as discussed above.

Public Response to the NPRMs:

The American Psychiatric Association (APA) was one among many organizations to submit a comment on the NPRMs. Notably, the APA cautioned the DEA from taking “too many steps backwards” and imposing futile restrictions on the practice of telemedicine during an “opioid public health emergency and nationwide mental health and access to care crisis.”

The APA produced five key recommendations that better balanced the DEA’s obligation to prevent drug diversion without restricting individuals’ access to life-saving technology. The recommendations include:

1. Allowance for referring practitioners to not be DEA-registered.
2. Reduction in administrative requirements for referring and prescribing practitioners.
3. Reduction in additional state-based registration requirements.
4. Removal of clinical decision-making from regulation in these proposed rules.
5. Clarification of key inconsistencies in the proposed rules.

The American Hospital Association (AHA) also submitted a comment letter to the DEA regarding the NPRMs. The AHA wrote that the exceptions for in-person medical evaluations under the Ryan Haight Act —specifically under the “other circumstances” catch-all— were opportunities for the DEA to build upon policies for the safe administration of prescriptions via telemedicine. However, the AHA felt that the DEA failed to expand upon prior policies and instead created “unnecessarily burdensome” limits to telemedicine that would adversely impact individuals’ access to healthcare.  

Conclusion:

The purpose of this rulemaking is to extend, for a limited period, the telemedicine flexibilities that existed during the federal COVID-19 PHE. Without this temporary regulation, the COVID-19 PHE telemedicine flexibilities for prescribing controlled substances would have expired at the conclusion of the PHE on May 11, 2023. Despite the uncertainty that lies ahead, the DEA and HHS now have time to address the 38,369 comments received in response to the two NPRMs. This extension will hopefully encourage the DEA to explore regulatory alternatives to expand access to telemedicine.

[1]  The term “valid prescription” means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by-

(i) a practitioner who has conducted at least 1 in-person medical evaluation of the patient; or

(ii) a covering practitioner. 21 USC § 829(e)(2).