Online Prescribing of Controlled Substances and the Opioid Epidemic
September 28, 2017
Digital Health Developments
Global Updates Provided by Faegre Baker Daniels
By: Libby Baney and Beena Patel, Faegre Baker Daniels Consulting
Federal Law Intended to Prevent Illegal Online Pharmacies. The Ryan Haight Online Pharmacy Consumer Protection Act was enacted in 2008 in response to the proliferation of rogue internet pharmacies selling controlled substances (CS) online, often, without requiring a prescription. Among other compliance measures, the Ryan Haight Act requires a provider to have conducted at least one in-person medical evaluation of the patient prior to issuing a prescription for a CS. However, the Act provides seven exceptions to the in-person medical evaluation requirement for the “practice of telemedicine.”
Since 2008, there has been substantial growth in telemedicine. As noted in the August 2017 Digital Health column, many states have updated their laws to affirmatively allow online prescribing via telemedicine, even for CS as long as it does not conflict with the Ryan Haight Act.
Technology can increase access to psychiatry services. More than 1 million telemedicine consultations are estimated to have occurred in the United States in 2016 for telepsychiatry alone. This can be attributed to three main drivers:
- growing use of telemedicine generally, including expanded access through private and government payors;
- the shortage of psychiatrists which compels patients to seek care via telemedicine from providers outside of their city or state; and
- the opioid epidemic, where telemedicine can be a tool to increase patient access to anti-addiction care.
On the latter point, earlier this year, University of West Virginia physicians published a study in the Journal of Addiction Medicine that examined if telepsychiatry could take the place of in-person group sessions for this patient population. The results suggest that a videoconferencing strategy could be a plausible option for medication-assisted treatment (MAT) programs.
The Ryan Haight Act and telepsychiatry. MAT for opioid abuse involves the use of CS, and therefore, is subject to the terms of the Ryan Haight Act. One often-used “practice of telemedicine” exception to the Act is that the online prescribing via telemedicine is being conducted while the patient is being treated by a “hospital or clinic” that is registered with Drug Enforcement Administration (DEA). Though the centers provide a broad array of needed clinical treatment and recovery services, many community addiction and behavioral health centers do not meet the qualifications to register with DEA as a “hospital or clinic.” Therefore, under the Act, these centers’ patients may not receive a prescription for a CS, eg, buprenorphine, via telemedicine without having a prior in-person medical evaluation from the prescriber.
The Ryan Haight Act, however, provides DEA with the ability to open a special registration process that would allow psychiatrists and physicians to prescribe CS via telemedicine without a prior in-person medical evaluation. But as telemedicine advocates and behavioral health providers have pointed out, DEA is still working on the development of a proposed rule to create this new pathway.
Recent Developments: In August 2017, the National Council for Behavioral Health, along with more than 30 community mental health clinics, sent a letter to DEA asking them to move forward with creating a regulatory pathway to enable telepsychiatry. Like NABP and .pharmacy registrants, the National Council understands the problem of illegal online drug sellers and the need to safeguard against drug abuse and diversion online. Citing NABP, the National Council explains:
Allowing home-based prescriptions would erode the Ryan Haight Act and invite rogue online pharmacies posing as telemedicine providers into the market. A simple online search returns websites that sell bottles of Percocet shipped directly to the customer’s house for $2 a pill. Currently the National Association of Boards of Pharmacy estimates there are roughly 3,300 active online drug sellers offering controlled substances in violation of existing law. Opening up online prescribing of controlled substances to patients not located in a DEA-registered facility—whether an existing DEA-registered facility or a facility registered under the new special registration process—risks making this problem worse.
Accordingly, the National Council urged DEA to take a measured approach to online prescribing of CS, creating a regulatory pathway that allows patients to receive treatment utilizing CS via telemedicine while balancing the interests of access to care and abuse prevention. The National Council recommends that DEA allows registration of health care centers that are not hospitals or clinics and authorizes remote prescribing of CS without a prior in-person medical evaluation only in such registered health care centers. They also recommend DEA prohibits online prescribing of opioid painkillers.
What Does DEA Say? In 2016, DEA announced plans to issue a new rule to activate the special registration process allowing physicians to use telemedicine to prescribe CS without an in-person exam. The most recent notice of rulemaking stated the proposed rule was expected to be issued in January 2017. At this time, however, the proposed rule has not yet been released.