Pain Care Legislation & Policy Update

On June 17, 2020, DCBA Law & Policy Managing Partner Michael Barnes presented alongside Wade Delk, Government Affairs Director of the American Society for Pain Management Nursing (ASPMN), for the Providers Clinical Support System (PCSS) 2020 Pain Care Legislation and Public Policy Webinar. Mr. Barnes and Mr. Delk provided an update on state and federal legislative and regulatory actions and proposals that may affect people with pain or opioid use disorder.

Topics included:

– The Pain Management Best Practices Interagency Task Force recommendation implementation plan and the April 2020 request from the Centers for Disease Control and Prevention (CDC) for comments on pain management options;

– The U.S. Department of Health and Human Services Office of Inspector General Toolkit for Calculating Opioid Levels and Identifying Patients at Risk of Misuse or Overdose, released in May 2020;

– CDC conclusions that, from 2017 to 2018, prescription opioid-involved death rates decreased by 13.5 percent, yet synthetic opioid-related death rates (involving illicit fentanyl, for example) increased by 10 percent;

– Federal cannabis and cannabidiol (CBD) policy and enforcement activity; and

– Research into new pain medications.

The PCSS webinar also covered issues associated with the COVID-19 public health emergency (PHE), including the need for practitioner and public awareness around COVID-19 serology testing reliability; the mental health impacts of COVID-19 on health care providers, first responders, and the public at large; and reports of changes in illicit substance supplies, drug abuse trends, and treatment initiation rates.

Mr. Barnes and Mr. Delk discussed numerous ways the federal government has provided regulatory flexibility during the PHE, such as:

– Allowing the prescribing of opioid pain medications after evaluating patients via non-public-facing audiovisual chat app, such as FaceTime, Facebook Messenger, Google Hangouts, or Skype;

– Permitting the prescribing of buprenorphine for opioid use disorder after evaluating patients over the telephone; and

– Increasing controlled substance supply quotas in response to medication shortages.

Mr. Barnes explained that some health care leaders are urging the federal government to make these COVID-19 regulatory flexibility measures permanent and to further deregulate the treatment of opioid use disorder by eliminating the federal X-waiver requirement.

The hour-long webinar concluded with a 10-minute question-and-answer session.

Find the replay of the webinar on the PCSS website.

Healthy Women Publishes Final Report on Women-Focused Chronic Pain Summit Where DCBA Attorney Presented on Treatment Barriers

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.

DEA Temporarily Relaxes Telemedicine Standards for Prescribing Buprenorphine During COVID-19 Outbreak

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.”[1] 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.[2]

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.[3] 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.[4]

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.

 

[1] 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).

[2] 21 U.S.C. § 829(e)(2)(A).

[3] 21 U.S.C. § 802(54).

[4] 21 U.S.C. § 802(54)(D).

FORE Issues Opinion Letter on Prescribing Buprenorphine with Telemedicine During COVID-19 Outbreak

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.

DCBA Attorneys to Present and Moderate at 2020 Rx Summit

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

Marketing and Communications Manager Meredith Shelton will represent DCBA at the firm’s Rx Summit booth during exhibit hours.