The Special Registration for Telemedicine: In Brief

Summary

Suppress:

In response to the concerns about the opioid epidemic, the Trump Administration proposed expanding access to telemedicine services such as for the prescribing of medicine used for substance abuse or mental health treatment. Telemedicine is the electronic delivery of a clinical health care service via a technological method. Section 311(h)(1) of the Controlled Substance Act (CSA), which was added by Section 3 of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act; P.L. 110-425), authorized the special registration for telemedicine with the goal of increasing patients’ access to practitioners that can prescribe controlled substances via telemedicine in limited circumstances. Section 802(21) of Title 21, U.S.C. defines a practitioner as

a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.

The registration would enable a practitioner to deliver, distribute, dispense, or prescribe via telemedicine a controlled substance to a patient who has not been medically examined in-person by the prescribing practitioner. For example in the event of an opioid overdose, a patient might need a prescription for an opioid antagonist such as naloxone from a practitioner who has never examined the patient in-person prior to the telemedicine encounter.

While the CSA authorized the special registration for telemedicine, practitioners have not been able to apply for this special registration. The Drug Enforcement Administration (DEA) has yet to finalize a rule on the registration’s application process and procedures and the limited circumstances that warrant it. As a result, Congress is considering the Special Registration for Telemedicine Clarification Act of 2018 (H.R. 5483). H.R. 5483 would require the DEA, in a joint effort with the Secretary of the Department of Health and Human Services (HHS), to issue a rule on the special registration for telemedicine within one year of the enactment of the bill (as amended). On June 12, 2018, the House passed H.R. 5483 under suspension of the rules. On June 13, 2018, the Senate referred the bill to the Senate Health, Education, Labor, and Pensions Committee.