[Federal Register Volume 88, Number 150 (Monday, August 7, 2023)]
[Notices]
[Pages 52210-52213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16889]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-407]
RIN 1117-AB40 and 1117-AB78


Practice of Telemedicine: Listening Sessions

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of meeting.

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SUMMARY: The Drug Enforcement Administration (DEA) is conducting public 
listening sessions to receive additional input concerning the practice 
of telemedicine with regards to controlled substances and potential 
safeguards that could effectively prevent and detect diversion of 
controlled substances prescribed via telemedicine. Specifically, DEA is 
inviting all interested persons, including medical practitioners, 
patients, pharmacy professionals, industry members, law enforcement, 
and other third parties to express their views at the listening 
sessions concerning the advisability of permitting telemedicine 
prescribing of certain controlled substances without any in-person 
medical evaluation at all, the availability and types of data that 
would be useful in detecting diversion of controlled substances via 
telemedicine that are either already reported or could be reported, and 
specific additional safeguards that could be placed around the 
prescribing of

[[Page 52211]]

schedule II controlled substances via telemedicine.

DATES: The listening sessions will be held on Tuesday, September 12, 
2023, and Wednesday, September 13, 2023, from 9 a.m. to 5:30 p.m. at 
DEA Headquarters, 700 Army Navy Drive, Arlington, VA 22202; (202) 307-
1000. Check-in will begin at 8 a.m.
    Meeting Attendance: Persons wishing to attend the listening 
sessions in person, space permitting, must complete and submit the 
attendance form available at DEA's Diversion Control Division website, 
https://apps.deadiversion.usdoj.gov/ListeningSession, no later than 
August 21, 2023. There is no fee to submit the attendance form or to 
attend the listening sessions. In-person attendance requests will be 
granted via random lottery among those who have submitted timely 
attendance forms. The listening sessions will also be livestreamed 
online.
    Meeting Presentations: DEA is accepting requests to make limited 
oral presentations during the listening sessions, as discussed further 
in this document. Oral presentations may be given in-person or by video 
teleconference. Persons wishing to give an oral presentation at the 
listening sessions, space and time permitting, must complete and submit 
the attendance form available at DEA's Diversion Control Division 
website https://apps.deadiversion.usdoj.gov/ListeningSession, check the 
box indicating the desire to present at the listening sessions, and 
provide a summary of the presentation in the appropriate form field. 
This form must be submitted no later than August 21, 2023. Persons and 
groups having similar interests may wish to consider consolidating 
their information for an oral presentation through a single 
representative. After reviewing the requests to present, DEA will 
respond to all persons who request to provide an oral presentation to 
notify them of the status of their request. DEA will exercise its 
discretion to select a cross-section of persons and organizations to 
present at the listening sessions based on: (1) the person or 
organization's ability to respond to the specific questions presented 
below with new information, including the capacity to provide data 
responsive to the questions; and (2) the person or organization's 
ability to represent stakeholders on a given issue, position, or 
interest as raised by the requests. If selected to give an oral 
presentation, DEA will notify the presenting person or organization of 
the amount of time available to present and the approximate time the 
participant's presentation is scheduled to begin.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 776-3882.

SUPPLEMENTARY INFORMATION:

Background

    Under the Ryan Haight Online Pharmacy Consumer Protection Act of 
2008 (the Ryan Haight Act), a prescribing practitioner--subject to 
certain exceptions--may prescribe controlled substances to a patient 
only if the practitioner has, at some point previously, conducted an 
in-person evaluation of that patient.
    The Ryan Haight Act and DEA's implementing regulations do not limit 
a practitioner's ability to prescribe controlled substances for a 
patient after the practitioner has conducted at least one in-person 
medical evaluation of the patient. The Ryan Haight Act applies only 
where the prescribing practitioner wishes to prescribe controlled 
substances and has not conducted an in-person medical evaluation prior 
to the issuance of the prescription. In addition, the Ryan Haight Act 
and DEA's implementing regulations do not apply to telemedicine, 
telehealth, or telepsychiatry not involving the issuing of 
prescriptions for controlled substances or to other aspects of 
telemedicine, telehealth, or telepsychiatry that are not otherwise 
specified in the Controlled Substances Act (CSA).
    In response to the COVID-19 Public Health Emergency (COVID-19 PHE) 
as declared by the Secretary of the Department of Health and Human 
Services (HHS) on January 31, 2020, pursuant to the authority under 
section 319 of the Public Health Service Act (42 U.S.C. 247), DEA 
granted temporary exceptions to the Ryan Haight Act and DEA's 
implementing regulations under 21 U.S.C. 802(54)(D),\1\ thereby 
allowing the prescribing of controlled substances via telemedicine 
encounters--even when the prescribing practitioner had not conducted an 
in-person medical evaluation of the patient--in order to prevent lapses 
in care.
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    \1\ William T. McDermott, DEA Dear Registrant letter, Drug 
Enforcement Administration (March 25, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf; 
Thomas W. Prevoznik, DEA Dear Registrant letter, Drug Enforcement 
Administration (March 31, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Fina
l)%20+Esign.pdf.
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    DEA recognizes the importance of telemedicine in providing 
Americans with access to needed medications, and DEA has been, and 
remains, committed to expanding access to telemedicine in a way that 
puts patients--and their safety--first, is simple to understand and 
apply, reflects technological advancements, and is consistent with 
lessons learned during the COVID-19 PHE and the ongoing opioid 
epidemic.
    Accordingly, on March 1, 2023, prior to the expiration of the 
COVID-19 PHE and with the intent to make permanent some of the 
telemedicine flexibilities established during the COVID-19 PHE, DEA, in 
concert with HHS, promulgated two notices of proposed rulemaking 
(NPRMs) in the Federal Register--Telemedicine Prescribing of Controlled 
Substances When the Practitioner and the Patient Have Not Had a Prior 
In-Person Medical Evaluation \2\ (the ``General Telemedicine NPRM'') 
and Expansion of Induction of Buprenorphine via Telemedicine Encounter 
\3\ (the ``Buprenorphine NPRM'').\4\ These proposed rules sought to 
expand patient access to prescriptions for controlled substances via 
telemedicine encounters relative to the pre-COVID-19 PHE landscape, 
when consistent with public health and safety, while maintaining 
effective controls against diversion. More specifically, the General 
Telemedicine NPRM would allow for the telemedicine prescription of non-
narcotic \5\ schedule III-V controlled substances when certain 
circumstances are met, and impose an initial limit on telemedicine 
prescriptions for a controlled substance to a 30-day supply.\6\ To 
prescribe an additional supply to that patient (either within that 
initial 30 days or after the

[[Page 52212]]

completion of the initial 30-day supply), the prescribing practitioner 
would generally be required to evaluate the patient in person. The 
Buprenorphine NPRM would impose the same initial 30-day supply limit 
and in-person medical evaluation requirements. The comment period for 
the two NPRMs closed on March 31, 2023.
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    \2\ 88 FR 12,875 (Mar. 1, 2023).
    \3\ 88 FR 12,890 (Mar. 1, 2023).
    \4\ The NPRMs were promulgated under authority granted to DEA 
and HHS pursuant to 21 U.S.C. 802(54)(G).
    \5\ Under the CSA, narcotic drugs are drugs that contain 
opiates, cocaine, or ecgonine, as well as certain related plant 
material. 21 U.S.C. 802(17). This definition includes buprenorphine, 
a narcotic drug that has been approved by the Food and Drug 
Administration for maintenance and detoxification treatment of 
opioid use disorder.
    \6\ The regulations proposed in the General Telemedicine NPRM 
would also allow a practitioner employed by the Veterans Health 
Administration or who has received a qualifying telemedicine 
referral from a practitioner who has conducted an in-person medical 
exam of the patient to prescribe via telemedicine any controlled 
substance (including schedule II controlled substances and 
narcotics) that the practitioner is otherwise authorized to 
prescribe, subject to the same circumstances and initial 30-day 
limit as telemedicine prescriptions for schedules III-V non-narcotic 
controlled substances.
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    DEA received a total of 38,369 public comments in response to the 
NPRMs--35,454 comments on the General Telemedicine NPRM and 2,915 
comments on the Buprenorphine NPRM. When combined, these were among the 
highest number of public comments received on an NPRM in DEA's history. 
DEA thanks all commenters for their input and has been considering the 
comments carefully. On May 10, 2023, DEA and HHS temporarily extended 
the telemedicine flexibilities in place during the COVID-19 PHE to 
permit further consideration of the comments and avoid lapses in 
care.\7\
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    \7\ On May 10, 2023, DEA and HHS jointly promulgated a temporary 
final rule (Temporary Rule) that extended the telemedicine 
flexibilities in place during the COVID-19 PHE to avoid lapses in 
care given the then-pending May 11, 2023 expiration of the COVID-
PHE. The Temporary Rule extends the full set of telemedicine 
flexibilities regarding prescription of controlled substances that 
were in place during the COVID-19 PHE through November 11, 2023. In 
addition, for any practitioner-patient relationships that have been 
or will be established on or before November 11, 2023, the full set 
of telemedicine flexibilities regarding prescription of controlled 
substances in place during the COVID-19 PHE will continue to be 
permitted via a one-year grace period through November 11, 2024. In 
other words, if a patient and a practitioner have established a 
telemedicine relationship on or before November 11, 2023, the same 
telemedicine flexibilities that have governed the relationship to 
that point are permitted until November 11, 2024. Temporary 
Extension of COVID-19 Telemedicine Flexibilities for Prescription of 
Controlled Medications, 88 FR 30037 (May 10, 2023) (to be codified 
at 21 CFR 1307 and 42 CFR 12).
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    Among the 38,369 comments submitted in response to the NPRMs, a 
significant majority expressed concern, with respect to at least some 
controlled substances, that the proposed regulations placed limitations 
on the supply of controlled substances that could be prescribed via 
telemedicine prior to an in-person medical evaluation. In addition, 
several hundred comments specifically raised the possibility of a 
separate Special Registration for those practitioners who seek to 
prescribe controlled substances without conducting an in-person medical 
evaluation of patients at all.
    DEA is open to considering--for some controlled substances--
implementation of a separate Special Registration for telemedicine 
prescribing for patients without requiring the patient to ever have had 
an in-person medical evaluation at all. DEA also observes that making 
permanent some telemedicine flexibilities on a routine and large-scale 
basis would potentially create a new framework for medicine that 
fundamentally expands access to controlled substances in a way that 
warrants a new framework for accountability based, in part, on 
increased data collection and visibility into prescription practices in 
order to ensure patient safety and prevent diversion in near-real-
time.\8\
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    \8\ Under the Ryan Haight Act, as a general matter, 
prescriptions for controlled substances may not be issued without a 
prior in-person medical evaluation of a patient. See 21 U.S.C. 
829(e)(1), 2(A)(i). This reflects a background presumption that, 
when an in-person touchpoint has not occurred, it may be more likely 
that there has not been ``adequate medical oversight'' underlying 
the issuance of a prescription for a controlled substance. See H.R. 
Rep. No. 110-869, pt. 1, at 12 (describing the general performance 
goals and objectives of the Ryan Haight Act as ``counter[ing] the 
growing sale of controlled substances over the internet without 
adequate medical oversight''). Notwithstanding the Ryan Haight Act's 
general prohibition, the law's provisions also created an exception 
to the prior in-person medical evaluation requirement for 
practitioners who engage in the practice of telemedicine under a 
special registration framework. See 21 U.S.C. 829(e)(3)(A), 831(h).
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    Accordingly, DEA has decided to hold the aforementioned public 
listening sessions to gather new information from interested persons. 
While DEA welcomes all relevant information or opinions regarding 
telemedicine, DEA is particularly interested in the following 
questions:
     If telemedicine prescribing of schedule III-V medications 
were permitted in the absence of an in-person medical evaluation, what 
framework, including safeguards and data, with respect to telemedicine 
prescribing of schedule III-V medications do you recommend to help DEA 
ensure patient safety and prevent diversion of controlled substances?
     Should telemedicine prescribing of schedule II medications 
never be permitted in the absence of an in-person medical evaluation? 
Are there any circumstances in which telemedicine prescribing of 
schedule II medications should be permitted in the absence of an in-
person medical evaluation? If it were permitted, what safeguards with 
respect to telemedicine prescribing of schedule II medications 
specifically would you recommend to help DEA ensure patient safety and 
prevent diversion of controlled substances?
     If practitioners are required to collect, maintain, and/or 
report telemedicine prescription data to DEA, what pieces of data 
should be included or excluded? What data is already reported to 
federal and state authorities, insurance companies, and other third 
parties?
     If pharmacies are required to collect, maintain, and/or 
report telemedicine prescription data to DEA, what pieces of data 
should be included or excluded? What data is already reported to 
federal and state authorities, insurance companies, and other third 
parties?

Meeting Participation

    These listening sessions are open to the public. DEA registrants 
(i.e., practitioners, pharmacies, manufacturers, distributors, and 
reverse distributors), ultimate users of controlled substances (i.e., 
patients and members of their households), persons and organizations 
representing state and local governments, law enforcement agencies, 
long term care facilities (i.e., hospices, nursing homes, and in-home 
care groups), and other concerned organizations may be particularly 
interested in these listening sessions.
    Persons wishing to attend in person or provide a limited oral 
presentation must register on the Diversion Control Division website at 
https://apps.deadiversion.usdoj.gov/ListeningSession, as outlined 
above. These listening sessions will also be livestreamed. DEA will 
publicize instructions for accessing the livestream at a later date. A 
copy of the transcript from the listening sessions will be made 
available at the DEA Diversion Control Program website, https://www.deadiversion.usdoj.gov. That transcript will be considered part of 
the rulemaking record.
    Persons needing any accommodations for a disability (e.g., sign 
language interpreter) are asked to notify DEA with their accommodation 
request no later than August 21, 2023. Such notification should be made 
to Scott A. Brinks, Regulatory Drafting and Policy Support Section, 
Diversion Control Division, Drug Enforcement Administration; Mailing 
Address: 8701 Morrissette Drive, Springfield, Virginia 22152; 
Telephone: (571) 776-3882.
    As these listening sessions are open to the public, confidential 
business information or other proprietary information should NOT be 
shared.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
August 2, 2023, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal

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Register Liaison Officer has been authorized to sign and submit the 
document in electronic format for publication, as an official document 
of DEA. This administrative process in no way alters the legal effect 
of this document upon publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-16889 Filed 8-4-23; 8:45 am]
BILLING CODE 4410-09-P