On October 24, 2018, the President signed the sweeping, opioid-focused SUPPORT for Patients and Communities Act (Pub. L. 115-271, the “Act”) into law. Title III, Chapter 4 of the Act, titled the Special Registration for Telemedicine Clarification Act of 2018, establishes a deadline for the Drug Enforcement Administration (DEA) to promulgate regulations for the special registration of practitioners to practice telemedicine, which would expand the ability of registered providers to prescribe controlled substances via telemedicine.
Law Prior to the Act
The Ryan Haight Online Pharmacy Consumer Protection Act (see 21 USC § 829(e)) generally prohibits the prescription of controlled substances via the internet—which effectively covers telemedicine as well—without a prior in-person visit with the patient unless one of a few narrow exceptions applies. One such exception is the “special registration” for telemedicine under the Controlled Substances Act (21 USC § 831(h)), which authorized the Attorney General to “issue to a practitioner a special registration to engage in the practice of telemedicine.” (21 USC § 831(h)(1).) However, activation of this telemedicine exception required the promulgation of “regulations specifying the limited circumstances in which a special registration . . . may be issued and the procedures for obtaining such a special registration.” (21 USC § 831(h)(2).) To date, no such regulations have been issued, rendering this dormant exception dormant and, thus, unavailable.
Summary of the New Law
The Special Registration for Telemedicine Clarification Act of 2018 amends Section 831(h)(2) of the Controlled Substances Act (21 U.S.C. § 831(h)(2)) to read as follows:
(2) REGULATIONS. — 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—
- the limited circumstances in which a special registration under this subsection may be issued; and
- the procedure for obtaining a special registration under this subsection.
Establishing a timeframe for the DEA to issue final regulations regarding the special registration means that there is a date in sight at which time providers will have greater clarity on how to pursue this special registration.
However, providers should not consider this development in a vacuum. Many states have enacted laws on prescribing via telemedicine, and some state requirements may be more restrictive.
Providers should monitor for notices regarding proposed regulations and consider preparing comments to the draft. Providers should also mark their calendars to watch for final regulations in fall 2019. Finally, providers should familiarize themselves with applicable state laws, especially to the extent they impose greater restrictions on the prescription of controlled substances via telemedicine.