U.S. Drug Enforcement Administration

The telehealth industry has experienced constant developments in the regulatory landscape at both the federal and state level over the past several years, and we are confident these changes will continue into 2019 as the utilization of telehealth services continues to evolve and mature. A notable area of activity is how regulators are approaching the telehealth industry, in particular remote prescribing applications of this platform.

On the federal level, we should expect to see promulgation of regulations by the U.S. Drug Enforcement Administration outlining the special registration exception as mandated by the SUPPORT Act passed in 2018, allowing a pathway for health care providers to prescribe controlled substances through telemedicine, as detailed in our prior post.

On the state level, as telehealth becomes a mainstream mode of health care delivery, we are seeing states attempt to legislate telehealth services in more targeted, and potentially contentious, areas of health care.  For example, the ability to remotely prescribe abortion drugs or medical marijuana are some of these areas:

  • Kansas legislators passed the “Kansas Telemedicine Act (House Bill No. 2028), which includes a provision explicitly prohibiting the delivery of any abortion procedure ordered via telemedicine. The prescription of certain drugs would be involved in such a procedure. The Kansas legislature had attempted in prior bills to ban abortions conducted through telemedicine. However, in a recent legal challenge to the prohibition, on December 31, 2018 a state judge issued a ruling which struck down the prohibition of telemedicine abortions within HB 2028.
  • Michigan legislators passed Senate Bill 1198 (which was vetoed by the Governor) to extend a law passed in 2012 prohibiting abortion procedures ordered via telemedicine. The original 2012 law, which was set to expire after December 31, 2018, prohibited physicians from diagnosing and prescribing drugs for abortion unless the physician performed a physical examination on the patient. The 2018 law would have made this prohibition a permanent law.
  • In New Mexico, Senate Bill 406, revises the state’s Lynn and Erin Compassionate Use Act, expanding access to medical marijuana. This bill increases the number of “debilitating medical conditions” qualifying access to medical marijuana. The bill also incorporates a definition of telemedicine into the proposed statute and allows the issuance of medical marijuana identification cards pursuant to diagnoses of “debilitating medical conditions” made in person or via telemedicine. This in effect would expressly allow remote prescribing of medical marijuana based upon telemedicine encounters.
  • In Washington, Senate Bill 5498 revises the medical marijuana laws to expressly accommodate telemedicine examinations in the remote prescribing of medical marijuana. However, this bill only allows for the renewal of medical marijuana prescriptions based upon telemedicine examinations. This bill keeps in place the state’s requirement of an in-person physical examination for initial access to medical marijuana. Furthermore, this bill makes available this telemedicine encounter option only to patients that would likely result in severe hardship due to the patient’s physical or emotional condition.

Whether or not these move forward this year, these instances are nonetheless an indicator that telehealth is maturing and becoming more ingrained in the discussion of modes of health care delivery.

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.