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DEA is promulgating regulatory changes which would clarify the rights and obligations for DATA-waived registrants when prescribing buprenorphine to patients with Opioid Use Disorder pursuant to a telemedicine encounter which utilizes audio-only telecommunication systems.

Statement of Need:

During the current opioid epidemic, there is a shortage of data-waived health care providers.  This proposed rule will allow for expanded access to opioid addiction treatment.

Summary of the Legal Basis:

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) was enacted to prevent the illegal distribution and dispensing of controlled substances by means of the Internet.  It did so by amending the Controlled Substances Act (CSA) to require, among other things, that the dispensing of controlled substances by means of the Internet be predicated on a valid prescription involving at least one in-person medical evaluation, with limited exceptions.  One of those exceptions is when the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have jointly, by regulation, determined a practice is being conducted under circumstances consistent with effective controls against diversion and otherwise consistent with the public health and safety.  DEA is amending its regulations, in concert with HHS, to expand the circumstances under which individual practitioners are authorized to prescribe schedule III-V controlled substances which are approved for treating opioid use disorder, either as medication maintenance or treatment for withdrawal management, referred to as maintenance or detoxification treatment via a telemedicine encounter, including an audio-only telemedicine encounter.

Alternatives:

There are no feasible alternatives to this proposed rule.

Anticipated Costs and Benefits:

The estimated costs for opioid use disorder and fatal opioid overdose in 2017 were estimated to be $1.02 trillion.  With regards to the opioid epidemic, the majority of the economic burden is due to reduced quality of life from opioid use disorder and the value of life lost due to fatal opioid overdose. Non-fatal costs include costs associated with health care, substance use disorder treatment, criminal justice, lost productivity, and the value of reduced quality of life.  While DEA is unable to quantify how many of the affected patients will be successfully treated for opioid use disorder or how many fatal opioid overdoses will be avoided as a result of this proposed rule, the potential economic benefit is disproportionately large compared to any cost associated with this rule.

Risks:

The proposed rule will reduce the requirements imposed on practitioners who wish to prescribe schedule III-V controlled substances as part of medication treatment for opioid use disorders.  DEA understands that there is a risk of misuse and diversion of drugs approved for the use in maintenance treatment or withdrawal management, which could be increased by expanded prescribing.

While the proposed rule may increase the risk of diversion, with the proposed safeguards, and given the safety profile of buprenorphine, DEA estimates this increased risk will be minimal.  Requirements to check the PDMP prior to issuance of a prescription, 30-day limitations, in-person requirements for follow-up appointments, and more detailed requirements for record-keeping are expected to minimize the diversion of buprenorphine via telemedicine, including audio-only telemedicine.