October 22, 2019

October 22, 2019

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October 21, 2019

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Letter from U.S. Senators Applies Additional Pressure to DEA to Promulgate “Special Registration” Rules Under the Ryan Haight Act

The calls for utilizing telemedicine in battling the opioid crises in the U.S. are growing louder. On January 30, 2018, Senators Claire McCaskill (D-Mo.), Lisa Murkowski (R-Alaska), and Dan Sullivan (R-Alaska), sent a letter to Robert W. Patterson, the Acting Administrator of the U.S. Drug Enforcement Administration (DEA), urging the agency to promulgate regulations that would allow healthcare providers to prescribe medication-assisted treatments via telemedicine for persons with opioid dependence disorder.

The letter specifically addresses the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (21 U.S.C. 802(54)) (the “Act”) as the primary stumbling block preventing physicians from prescribing medication-assisted treatments via telemedicine to patients seeking treatment for opioid dependence disorder. The Act essentially prohibits physicians from remotely prescribing any controlled substances through telemedicine unless they first conduct an in-person examination with the patient, or the patient is being treated by and is physically located at a DEA registered hospital or clinic.  However, through the Act, Congress delegated authority to the DEA to create a “special registration” under 21 U.S.C. 802(54)(E), which would allow providers to practice telemedicine without being “subject to the mandatory in-person medical evaluation requirement” under the Act.  Yet, as we discussed in a recent blog, to date the DEA has taken virtually no actions to promulgate any rules that would allow DEA to issue such a special registration.

In October 2017, President Trump declared the opioid epidemic as a public health emergency. As we stated in a November 2017 blog, this declaration technically permits the DEA to authorize a separate method to permit prescription of controlled substances under the Act under 21 U.S.C. 802(54)(D), which would likely not be subject to rulemaking or notice and comment given that such authorization would terminate with the conclusion of the public health emergency.  In conjunction with President Trump’s statement, The President’s Commission on Combating Drug Addiction and the Opioid Crisis recommended the use of telemedicine to assist in expanding access to treatments for patients with opioid dependence disorder.  The Commission explicitly recommended that “federal agencies revise regulations . . . to allow for [substance use disorders] treatment via telemedicine.”  But even with the recent January 2018 extension of the public health emergency declaration until April 23, 2018, the agency has remained silent regarding the exemption.

The letter provides examples of how restricting telemedicine providers from prescribing anti-addiction medication continues to disadvantage rural Americans who do not readily have access to dedicated treatment centers and mental health professionals. For example, the letter states that in Missouri, “98 out of 101 rural counties lack a licensed psychiatrists—“a dangerous scenario that has contributed to higher rates of hospitalizations, emergency room visits, drug addiction and suicide in rural areas.[1]””  The letter directly calls on Acting Administrator Patterson and the agency to “immediately move to expedite the rulemaking process to create a special registration class of providers permitted to prescribe opioid-based medication-assisted addiction therapies via telemedicine.”  The letter emphasizes that the Senators are asking for the agency to take discrete action to treat patients with opioid dependence disorders in rural regions of the country, and not to promulgate a rule that would allow general prescribing of controlled substances for pain management, pain treatment, or any other pain-related purposes.

With the shortage of mental and behavioral health providers in the U.S., it is unsurprising that members of Congress in states with few providers or geographic challenges for patients seeking treatment have become vocal supporters of utilizing telemedicine as a means to combat growing opioid addiction problems in their states. Several state legislatures, including Indiana, Hawaii, and Florida,have or are in the midst of passing legislation to make it easier for providers to prescribe controlled substances to treat opioid dependence disorder via telemedicine.  As the letter stresses, “[t]he severity of the U.S. opioid crises demands nothing less than immediate action on this issue.”


[1] The quote was first written in Telepsychiatry helps with mental health burdens in rural Missouri, St. Louis Post-Dispatch, by Michele Munz (May 20, 2017) available at http://www.stltoday.com/lifestyles/health-med-fit/health/telepsychiatry-helps-with-mental-health-burdens-in-rural-missouri/article_495462ea-0ccb-58ee-9aa1-ce32930398ba.html.

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About this Author

Bradley Davidsen, Epstein Becker Law Firm, Health Care Attorney
Associate

Mr. Davidsen is an Associate in the Health Care and Life Sciences practice, in the Chicago office of Epstein Becker Green.

Mr. Davidsen:

  • Advises clients on the research, development, and approval of pharmaceuticals, biologics, and medical devices

  • Develops clinical trial agreements, vendor agreements, informed consent documents, and related materials for clinical research sponsors, and negotiates agreements with clinical research institutions and...

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Daniel Kim, Epsten Becker Law Firm, Washington DC, Healthcare law
Associate

DANIEL KIM is an Associate in the Health Care and Life Sciences practice, in the Washington, DC, office of Epstein Becker Green. He will be focusing his practice on FDA marketing approval of medical devices and pharmaceutical, reimbursement and compliance matters affecting health care medical device manufacturers, telehealth and telemedicine, HIPAA privacy and security, regulatory health care due diligence, and compliance issues.

Mr. Kim received his J.D., cum laude, from American University Washington College of Law. He obtained an M.A. in Anatomy and Neurobiology from Boston University School of Medicine, where he served as a surgical technician. He also received a B.A. in Biology, with a concentration in Neuroscience, from Boston University.

While attending law school, Mr. Kim clerked at the U.S. Attorney’s Office for the District of Columbia and at the Medicare Operations Division of the U.S. Department of Health and Human Services’ Departmental Appeals Board. Later, he interned at the Commissioner’s Office of the U.S. Food and Drug Administration and at the Office of General Counsel for Doctor on Demand, Inc., where he assisted in researching state telehealth laws and regulations, and developing and implementing HIPAA privacy and security and company compliance policies.

Before going to law school, Mr. Kim worked for six years as a research assistant at Boston Children’s Hospital, studying potential therapeutic treatments for spinal cord injuries.

 

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