Last week, the United States Congress passed a 250-page bill addressing the opioid crisis entitled SUPPORT for Patients and Communities Act (the “Opioid Act”). However, at page 56 of the Opioid Act, there is a short section requiring the United States Drug Enforcement Agency (the “DEA”) to pass the long-awaited rules to permit physicians to prescribe controlled substances via telemedicine.
By way of background, this section of the Opioid Act revises a prior law passed by Congress a decade ago, entitled the “Ryan Haight Online Pharmacy Consumer Protection Act of 2008” (the “Ryan Haight Act”). Congress passed the Ryan Haight Act to address the increase in rogue Internet providers who were selling controlled substance prescriptions via the Internet without a proper examination of the patient.
To curtail these rogue Internet prescribing practices, the Ryan Haight Act defined a few narrow exceptions that would allow a physician to prescribe controlled substances via technology when the physician had not personally examined the patient in a traditional in-person encounter. The Ryan Haight Act also mandated the DEA to create a permit application process for physicians to request permission to prescribe controlled substances via telemedicine when it was clinically appropriate to do so.
However, after 10 years, the DEA has still not created the Congressionally-mandated telemedicine permit prescribing pathway from the Ryan Haight Act, and the new Opioid Act addresses this oversight. Specifically, the Opioid Act includes the following language at sections 3231 and 3232 of the Act:
“SEC. 3231. SHORT TITLE.
This chapter may be cited as the “Special Registration for Telemedicine Clarification Act of 2018”.
SEC. 3232. REGULATIONS RELATING TO A SPECIAL REGISTRATION FOR TELEMEDICINE.
Section 311(h)(2) of the Controlled Substances Act (21 U.S.C. 831(h)(2)) is amended to read as follows:
Not later than 1 year after the date of enactment of the SUPPORT for Patients and Communities Act, in consultation with the Secretary, the Attorney General shall promulgate final regulations specifying: (A) the limited circumstances in which a special registration under this subsection may be issued; and (B) the procedure for obtaining a special registration under this subsection.”
Thus, the key issue that the required regulations will address over the next year is the specific definition for the “limited circumstances” under which someone may receive one of these permits. Because of this missing definition, it could benefit companies and providers who have an interest in receiving one of these telemedicine permits to participate in this rulemaking process and submit comments on the specific definition of the “limited circumstances” that they believe the DEA should consider for granting, or denying, a permit request.
This new telemedicine prescribing permit would be particularly beneficial to healthcare providers who practice in a specialty for which there is a shortage of licensed providers. For example, there is currently a shortage of child and adult psychiatrists to meet the mental health needs of all patients in the United States through a traditional in-person examination of the patient. Thus, if mental healthcare providers obtained this permit, it could potentially improve access to mental health care in the United States in underserved communities for those circumstances when it is clinically appropriate to provide those services via telemedicine, in lieu of a traditional in-office visit.
We will be monitoring this telemedicine permit regulatory process, and you may contact our one of our healthcare attorneys with any questions you may have about this law. You may also contact one of our healthcare attorneys for guidance on submitting comments on the DEA’s proposed permit rules that address the needs of your specific business model.