Healthy Women has published a final report on the organization’s July 2019 event, the Science, Innovation, and Technology Summit: Chronic Pain in Women— Focus on Treatment, Management and Barriers. Clinical professionals, researchers and policymakers, and representatives from federal agencies, industry, nonprofit organizations, and advocacy groups came together at the event to advance the dialogue on effective treatment and management of chronic pain in women. DCBA attorney, Shruti Kulkarni, presented at the summit and discussed how gender differences play a role in disease progression, effects of medications, and barriers to treatment. Specifically, she discussed the unique legal and societal barriers women face in obtaining medically necessary treatment, including lack of childcare and punitive attitudes towards pregnant and parenting women.
The Drug Enforcement Administration (DEA) has temporarily relaxed the federal requirements for prescribing buprenorphine for opioid use disorder (OUD) via telemedicine during the COVID-19 public health emergency.
As a general rule, the federal Controlled Substances Act (CSA) requires a valid prescription before a controlled prescription medication may be delivered, distributed, or dispensed by means of the “Internet.” A “valid prescription” includes a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by a practitioner who has conducted at least 1 in-person medical evaluation of the patient.
However, the CSA contains several exceptions to the in-person exam requirement when a practitioner is engaged in the delivery, distribution, or dispensing of a controlled substance through the practice of telemedicine. Most notably, an in-person exam is not required if the practice of telemedicine is being conducted during a public health emergency declared by the Secretary of the U.S. Department of Health and Human Services (HHS), and involves patients located in such areas, and such controlled substances, as the Secretary, with the concurrence of the Attorney General (i.e., the DEA), designates.
The DEA has published an information page setting forth the CSA’s requirements for prescribing controlled medications via telemedicine during the public health emergency related to the COVID-19 outbreak. Specifically, prescriptions for controlled medications must be issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice; the telemedicine communication must be conducted using an audio-visual, real-time, two-way interactive communication system; and the practitioner must act in accordance with all applicable federal laws (e.g., HIPAA) and state laws (e.g., state controlled substances acts, laws governing nurse practitioner and physician assistant prescriptive authority).
Recognizing that DATA-waived practitioners often may not be able to reach patients with OUD using audio-visual technology during the COVID-19 outbreak, the DEA posted guidance on March 31 that temporarily relaxes the audio-visual requirement when prescribing buprenorphine for OUD. Specifically, DEA stated that for the duration of the public health emergency (unless DEA specifies an earlier date), DATA-waived “practitioners have flexibility . . . to prescribe buprenorphine to new and existing patients with OUD via telephone . . . without first conducting an examination of the patient in person or via [audio-visual] telemedicine.” At the same time, qualified practitioners must continue to meet their obligation to prescribe only where there is a legitimate medical purpose while acting in the usual course of professional practice.
 The term “Internet” means “collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected worldwide network of networks that employ the Transmission Control Protocol/Internet Protocol, or any predecessor or successor protocol to such protocol, to communicate information of all kinds by wire or radio.” 21 U.S.C. § 802(50) (2018); 21 U.S.C. § 829(e)(1) (2018).
 21 U.S.C. § 829(e)(2)(A).
 21 U.S.C. § 802(54).
 21 U.S.C. § 802(54)(D).
The COVID-19 outbreak has presented extraordinary challenges in prescribing buprenorphine to new and existing patients with opioid use disorder (OUD). Telemedicine presents an opportunity to reach these patients and promote continuity of care; however, rapidly evolving circumstances have caused confusion among many practitioners as to their rights and obligations under federal law when prescribing controlled substances using telemedicine technologies.
For instance, the Drug Enforcement Administration (DEA) published an information page describing what is required under the federal Controlled Substance Act to prescribe controlled medications through telemedicine, including the requirement to use audio-visual technology to conduct new patient exams. Shortly thereafter, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued an FAQ document for opioid treatment programs (OTPs) stating that DATA-waived practitioners may prescribe buprenorphine to new patients after conducting telephone-based exams. Nearly two weeks later, the DEA then posted guidance stating that, under normal circumstances, such telephone-base exams are “not consistent with the framework of the CSA” but are temporarily permissible during the public health emergency.
To help practitioners navigate the quickly changing legal landscape during the public health emergency, the Foundation for Opioid Response Efforts (FORE) has issued a legal opinion letter, prepared by DCBA associate Daniel McClughen, analyzing four hypothetical clinical scenarios for prescribing buprenorphine for OUD. The letter is published on the foundation’s Resources page, where stakeholders can access timely information related to practicing medicine during the COVID-19 outbreak.
Four DCBA Law & Policy attorneys have been selected to speak or moderate at the Rx Drug Abuse & Heroin Summit in Nashville next month. DCBA will also exhibit at the conference.
Partner Stacey Worthy will join two nationally renowned addiction physicians in presenting, “Duking It Out Over Electronic Data-Sharing: Law, Ethics, and Best Practices in Addiction Medicine” on Monday, April 13:
Privacy regulations under 42 CFR Part 2 are intended to mitigate stigma, reduce discrimination, and encourage individuals to seek treatment for substance use disorders (SUDs). There is current debate over whether, in the era of electronic health records, Part 2’s protections are overly-broad, prevent care coordination, and result in inappropriate prescribing of controlled substances. In response, federal policymakers have begun taking action to loosen Part 2 protections and clarify ambiguities.
Ms. Worthy will provide an overview of health privacy laws, regulations, and recently proposed rules and legislation. H. Westley Clark, M.D., M.P.H., J.D. will provide arguments in support of the current regime and describe best practices involving privacy protections. Andrea Grubb Barthwell, M.D., DFASAM will provide arguments in support of a new regime that allows for greater data sharing among providers.
Senior Associate Shruti Kulkarni will speak during the session entitled, “Innovative Treatments in Jails: What Correctional Administrators, Health Care Providers, and Advocates Need to Know” on Monday, April 13:
Two-thirds of individuals in jail meet the criteria for substance dependence or use. Nevertheless, correctional facilities have traditionally not been resourced adequately to provide SUD treatment, including medication when appropriate. Since 2018, numerous court cases have been filed that have helped draw attention to SUD treatment for incarcerated individuals at the national, state, and local levels.
Ms. Kulkarni will join John W. Thompson, M.D., Chair and Professor of Psychiatry and Behavioral Sciences at Tulane University School of Medicine, and Sheriff Craig Apple of Albany County, New York in discussing timely medical, legal, and operational developments for SUD treatment in correctional settings.
Associate Daniel McClughen will co-present the session entitled, “Driving Change: Use of Mobile Medical Services and Technology to Improve Addiction Treatment Capacity” on Tuesday, April 14:
The use of mobile treatment resources and technology, such as telehealth, treatment vans, mobile apps, and screening kiosks, has the potential to positively impact the nation’s drug overdose crisis. Yet, there are many medical, legal, and practical issues that must be considered when implementing such resources in addiction treatment settings.
Mr. McClughen will explain how health care programs and clinicians can deploy mobile resources and technology in an evolving legal environment. He will co-present with Eric Weintraub, M.D., who will discuss his experience implementing a telemedicine program and mobile treatment unit (MTU) to deliver medication-based treatments to patients with opioid use disorder (OUD). Dr. Weintraub will also share outcomes data and provide recommendations for implementing successful telemedicine and MTU programs. Managing Partner Michael Barnes, a member of the Rx Summit advisory board since the conference’s inception, will moderate this session.
Mr. Barnes will also moderate two additional Rx Summit sessions:
– Stigma as a Barrier to Treatment and Recovery: Developing a Targeted Response, Wednesday, April 15
– OUD and the Americans with Disabilities Act: Eliminating Discriminatory Barriers to Treatment and Recovery, Wednesday, April 15
On February 26, 2020, DEA issued a proposed rule titled Registration Requirements for Narcotic Treatment Programs with Mobile Components. The proposed rule would waive the requirement of a separate registration for opioid treatment programs (OTPs) that utilize a mobile component.
The Controlled Substances Act (CSA) generally requires, with certain exceptions, all persons who dispense controlled substances to obtain a separate registration at each “principle place of business or professional practice” where they dispense a controlled substance. The CSA also, however, authorizes the Administrator of the Drug Enforcement Administration (DEA), by delegation of the Attorney General, to issue regulations that would waive the registration requirement in certain instances if he finds it consistent with the public health and safety.
If finalized, the proposed rule would waive the requirement of a separate registration for OTPs that provide medication for opioid use disorder out of mobile vehicles. It would allow registrants to dispense controlled medications from schedules II-V for the purpose of maintenance or detoxification services at a location remote from, but within the same state as, the OTP’s registered location. A registrant that intends to operate a mobile OTP must notify the local DEA office in writing and obtain explicit written approval from the local DEA office prior to operating the mobile OTP.
DEA stated that the proposed rule is consistent with the public health and safety because it will expand access to OUD treatment in rural and other underserved areas with minimal risk of diversion.