Michael C. Barnes, JD, Principal Attorney at Sequel Legal and Chairman of the Center for U.S. Policy, will speak at the American Pharmacists Association (APhA) 2021 Annual Meeting on Monday, March 15. Mr. Barnes will co-present the session, entitled “Don’t ‘Just Say No’: Preventing Diversion and Addressing Medical Needs,” with Jake Nichols, PharmD, CEO of Professional Recovery Resources. Mr. Barnes will provide an overview of federal and state laws relevant to a pharmacist’s decision on whether to dispense a controlled medication, including the federal Controlled Substances Act, state mandatory consultation or refusal laws, and professional licensing board rules. The APhA Annual Meeting will take place online March 12-15.
Pain News Network (PNN) recently quoted Michael Barnes, JD in an article about Drug Enforcement Administration (DEA) impersonators. PNN Editor Pan Anson reported that the DEA has issued a warning to health care providers, pharmacists, and the public about criminals posing as DEA agents and attempting to extort money from them.
According to Barnes, “The scammers are well enough informed of the tactics DEA is employing against controlled-medication prescribers to be able to replicate them.”
On June 17, 2020, Michael Barnes, JD 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.
– 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 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. Shruti Kulkarni, JD 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).