Archive for month: August, 2023
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:
- Allowance for referring practitioners to not be DEA-registered.
- Reduction in administrative requirements for referring and prescribing practitioners.
- Reduction in additional state-based registration requirements.
- Removal of clinical decision-making from regulation in these proposed rules.
- 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
By: Emma Smith, Legal Researcher and J.D. Candidate, ASU Sandra Day O’Connor College of Law, and
Erica N. White, J.D., Research Scholar, Center for Public Health Law & Policy, ASU Sandra Day O’Connor College of Law
On July 15, 2021, U.S. Surgeon General Dr. Vivek H. Murth released an advisory on the spread of misinformation during the COVID-19 pandemic, referring to misinformation as a “serious threat” to the public’s health. FDA Commissioner Robert Califf has made similar remarks, stating in April 2023 that misinformation is “contributing to the three- to five-year lower life expectance in the United States compared to similar countries.” While the threat of misinformation to the public’s health is not new, it ascended to unprecedented levels during the pandemic. Consequently, so has the need to address its spread legally — beginning with Section 230 of the federal Communications Decency Act (CDA) of 1996.
COVID-19 and Misinformation
Resulting in the deaths of over 1.1 million Americans, the COVID-19 pandemic represents one of the greatest public health emergencies of all time, as well as a seminal illustration of the negative impacts of misinformation on health outcomes. As reported on NPR on May 16, 2022, one-third of COVID-19 deaths are attributable to unvaccinated individuals, many of whom were concerned about COVID-19 vaccine safety despite little evidence of the same. A 2021 Kaiser Family Foundation study found that 64% of unvaccinated adults reported that they believed or were uncertain as to 4 or more misstatements about COVID-19 which influenced their choice whether to be vaccinated. Online and other sources of vaccine misinformation clearly contributed to hundreds of thousands of preventable COVID-19 deaths.
The Legal Rise of Online Misinformation
In 1995, the New York Supreme Court found in Stratton Oakmont, Inc. v. Prodigy Services Company that an internet service company was liable for defamation. The company did not make libelous statements directly, but rather solely as a “publisher” (and not a “distributor”) of such content. Furthermore, Stratton established that a platform would be considered a publisher by simply policing content. Concerned that Stratton and additional cases would discourage media development and sites from policing their content, Congress passed § 230 of the CDA the following year. Specifically, § 230 of the CDA provides legal protection from defamation claims to social media platforms that merely allow or choose not to remove harmful content posted by platform users.
Twenty-five years later, CDA’s applicability remains largely unchanged—a fact that seems unlikely to change based on recent U.S. Supreme Court assessments under the CDA and other laws. In May 2023, the Court issued its opinion in Twitter, Inc. v. Taamneh determining that internet platforms were not liable under the Anti-Terrorism Act for merely allowing users to post content onsite. Such allowances do not equate to “providing substantial assistance” under the Act. In Gonzalez v. Google, LLC, the Court avoided addressing the scope of CDA § 230, finding that the plaintiff’s complaint alleging Google was liable for an ISIS terrorist attack as ISIS utilized Google for advertisements would likely fail under Twitter. On May 30, 2023, the Court denied certiorari in Jane Does No. 1-6 v. Reddit, Inc., declining to rule on whether Reddit is protected from liability for allowing platform users to post child pornography on their site under § 230.
Collectively, the Court’s reticence to rule allows social media platforms such as Twitter, Facebook, and Reddit to continue to be shielded from liability for harmful content published by users of their sites. In turn, the “legal incentives for platforms to respond to digital misinformation on critical health issues” are minimal. While some platforms have issued internal policies to address the spread of misinformation, content creators continue to post misinformation deleterious to the public’s health openly and innovatively via new technology and the developing capabilities of artificial intelligence.
Time to Act
So much has changed since 1996 when CDA § 230 protections were enacted. The dangers of social media have become clearer as evinced during the riot on Capitol Hill on January 6, 2021 and through impacts over years related to human trafficking, suicide and self-harm, and substance abuse. Social media harms may exceed prior perceptions among legislators and the public. Yet, these harms are real, evolving, and escalating. With public health and safety at risk, the time is now to seriously re-evaluate CDC § 230 protections.
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.