COVID-19 SAMHSA Telemedicine (Phone)

us-doj-guidance-DEA-DC-022COVID-19 SAMHSA Telemedicine (Phone)Guidance

U. S. Department of Justice
Drug Enforcement Administration
www.dea.gov
Dear Registrant:
In light of the nationwide public health emergency declared by the Secretary of Health and
Human Services (HHS) on January 31, 2020, as a result of the Coronavirus Disease 2019 (COVID-
19), the Drug Enforcement Administration (DEA) is exercising its authorities to provide flexibility
in the prescribing and dispensing of controlled substances to ensure necessary patient therapies
remain accessible. As part of this effort, DEA has partnered with the Substance Abuse and Mental
Health Services Administration (SAMHSA) to ensure authorized practitioners may admit and treat
new patients with opioid use disorder (OUD) during the public health emergency. DEA has already
announced that practitioners may prescribe controlled substances to patients using telemedicine
without first conducting an in-person evaluation during this public health emergency under 21
U.S.C. 802(54)(D).1 Today, DEA notes that practitioners have further flexibility during the
nationwide public health emergency to prescribe buprenorphine to new and existing patients with
OUD via telephone by otherwise authorized practitioners without requiring such practitioners to first
conduct an examination of the patient in person or via telemedicine.2 This additional flexibility
under which authorized practitioners may prescribe buprenorphine to new patients on the basis of a
telephone evaluation is in effect from March 31, 2020, until the public health emergency declared by
the Secretary ends, unless DEA specifies an earlier date.
The Controlled Substances Act (CSA) allows practitioners to dispense narcotic drugs, including
buprenorphine, to individuals with OUD for maintenance or detoxification treatment if the
practitioners separately register with DEA as an opioid treatment program (OTP). See 21 U.S.C.
823(g)(1). The CSA also permits practitioners to dispense narcotic drugs for OUD by providing for
a waiver of this separate registration requirement for practitioners dispensing schedule III, IV, or V
narcotic controlled substances approved by the Food and Drug Administration specifically for the
use in maintenance or detoxification treatment. Id. at 21 U.S.C. 823(g)(2); 21 CFR 1301.28.
Currently, the only controlled substance meeting these criteria is buprenorphine. To qualify for the
waiver to dispense buprenorphine for maintenance or detoxification treatment, the practitioner must
meet the qualifications set by SAMHSA. Practitioners who have met these SAMHSA qualifications
and obtained authorization from DEA to dispense buprenorphine for maintenance or detoxification
treatment are often referred to as “DATA-waived practitioners” (in reference to the Drug Addiction
Treatment Act of 2000, which added 21 U.S.C. 823(g)(2) to the CSA).
1 See https://www.deadiversion.usdoj.gov/coronavirus.html.
2 This letter only addresses the topic of prescribing buprenorphine for maintenance and detoxification treatment. The
dispensing of methadone for maintenance and detoxification treatment is addressed in a separate letter.
8701 Morrissette Drive
Springfield, Virginia 22152
DEA Qualifying Practitioners
DEA Qualifying Other Practitioners
Complete printed PDF page 1
Under the CSA, all prescriptions for controlled substances, including those issued for
maintenance or detoxification treatment, must be issued for a legitimate medical purpose by a
practitioner acting in the usual course of his/her professional practice. See 21 CFR 1306.04(a). 	As
noted above, despite the CSA’s limitations on issuing prescriptions for controlled substances by
means of the Internet, for the duration of the public health emergency, a practitioner may prescribe a
controlled substance to a new patient via telemedicine—using a real-time, two-way, interactive
audio-visual communication—without first conducting an in-person examination. 3 See 21 U.S.C.
802(54)(D).
Independently, SAMHSA’s regulations also require that an OTP conduct an in-person medical
evaluation of a patient before prescribing or directly dispensing controlled substances, including
buprenorphine, for maintenance treatment or detoxification. See 42 CFR 8.12(f)(2). On March 19,
2020, however, SAMHSA exempted OTPs from the requirement that they perform such an in-
person physical evaluation for any patient who will be treated by the OTP with buprenorphine if a
program physician, primary care physician, or an authorized healthcare professional under the
supervision of a program physician, determines that an adequate evaluation of the patient can be
accomplished via the use of a telephone. SAMHSA also announced that it was allowing DATA-
waived practitioners to prescribe buprenorphine for maintenance or detoxification treatment to do so
via telephone, “while complying with all applicable standards of care.”4
Under normal circumstances, DEA would not consider the initiation of treatment with a
controlled substance based on a mere phone call to be consistent with the framework of the CSA
given that doing so creates a high risk of diversion. However, in light of the extraordinary
circumstances presented by the COVID-19 public health emergency, and being mindful of the
exemption issued by SAMHSA, DEA likewise advises that, only for the duration of the public
health emergency (unless DEA specifies an earlier date), OTPs should feel free to dispense, and
DATA-waived practitioners should feel free to prescribe, buprenorphine to new patients with OUD
for maintenance treatment or detoxification treatment following an evaluation via telephone voice
calls, without first performing an in-person or telemedicine evaluation. This may only be done,
however, if the evaluating practitioner determines that an adequate evaluation of the patient can be
accomplished via the use of a telephone. The prescription also must otherwise be consistent with
the practitioner’s aforementioned obligation under the CSA and DEA regulations to only prescribe
controlled substances for a legitimate medical purpose while acting in the usual course of
professional practice.
3 Where a prescription for a controlled substance is issued by means of the Internet, the CSA (as amended by the Ryan
Haight Act) requires that such prescription involve at least one in-person medical evaluation, with limited exceptions.
After conducting one in-person medical evaluation, a practitioner may thereafter prescribe controlled substances by
means of the Internet or via telephone. Except where an exception applies, however, a new patient must ordinarily be
examined in-person prior to a practitioner prescribing or dispensing a controlled substance to the patient. One such
exception is an examination via telemedicine conducted pursuant to 21 U.S.C. 802(54)(D).
4 https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
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We hope this information is helpful. For more information from SAMHSA please visit
www.samhsa.gov. For information regarding DEA’s Diversion Control Division please visit
www.DEAdiversion.usdoj.gov. Please contact the Diversion Control Division, Policy Section at
(571) 362-3260 if you seek additional assistance regarding this or any other matter.
Guidance documents, like this document, are not binding on the public and lack the force and
effect of law, unless expressly authorized by statute or expressly incorporated into a contract, grant,
or cooperative agreement. Consistent with Executive Order 13891 and the Office of Management
and Budget implementing memoranda, the Department will not cite, use, or rely on any guidance
document that is not accessible through the Department’s guidance portal, or similar guidance
portals for other Executive Branch departments and agencies, except to establish historical facts. To
the extent any guidance document sets out voluntary standards (e.g., recommended practices),
compliance with those standards is voluntary, and noncompliance will not result in enforcement
action. Guidance documents may be rescinded or modified in the Department’s complete discretion,
consistent with applicable laws.
Sincerely,
Thomas W. Prevoznik
Deputy Assistant Administrator
Diversion Control Division
DEA068 – March 31, 2020
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