`[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Rules and Regulations]
[Pages 6504-6523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01049]



[[Page 6503]]

Vol. 90

Friday,

No. 11

January 17, 2025

Part VI





Department of Justice





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 Drug Enforcement Administration





Department of Health and Human Services





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21 CFR Part 1306

42 CFR Part 12

21 CFR Parts 1300, 1301, et al.





Milk in the Northeast and Other Marketing Areas; Uniform Pricing 
Formula Provisions; Continuity of Care via Telemedicine for Veterans 
Affairs Patients; Special Registrations for Telemedicine and Limited 
State Telemedicine Registrations; Final Rule

  Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules 
and Regulations  

[[Page 6504]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1306

[Docket No. DEA-948]
RIN 1117-AB78

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 12


Expansion of Buprenorphine Treatment via Telemedicine Encounter

AGENCY: Drug Enforcement Administration, Department of Justice; 
Substance Abuse and Mental Health Services Administration, Department 
of Health and Human Services.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration and the Department of 
Health and Human Services are amending their regulations to expand the 
circumstances under which practitioners registered by the Drug 
Enforcement Administration are authorized to prescribe schedule III-V 
controlled substances approved by the Food and Drug Administration for 
the treatment of opioid use disorder via a telemedicine encounter, 
including an audio-only telemedicine encounter. Under these new 
regulations, after a practitioner reviews the patient's prescription 
drug monitoring program data for the state in which the patient is 
located during the telemedicine encounter, the practitioner may 
prescribe an initial six-month supply of such medications (split 
amongst several prescriptions totaling six calendar months) through 
audio-only means. Additional prescriptions can be issued under other 
forms of telemedicine as authorized under the Controlled Substances 
Act, or after an in-person medical evaluation is conducted. This 
regulation also requires the pharmacist to verify the identity of the 
patient prior to filling a prescription. The Ryan Haight Online 
Pharmacy Consumer Protection Act of 2008 generally requires an in-
person medical evaluation prior to issuance of a controlled substance 
prescription. However, this regulation falls under one of the 
exceptions found within the Ryan Haight Act. Additionally, this 
regulation does not affect practitioner-patient relationships in cases 
where an in-person medical evaluation has previously occurred. The 
purpose of this regulation is to prevent lapses of care by continuing 
some of the telemedicine flexibilities that currently exist for those 
patients seeking treatment for opioid use disorder.

DATES: This rule is effective February 18, 2025.

FOR FURTHER INFORMATION CONTACT: Heather E. Achbach, Regulatory 
Drafting and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Telephone: (571) 776-3882.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

    This final rule falls under the last category of telemedicine under 
the Ryan Haight Act, Public Law 110-425, 122 Stat. 4820 (2008), which 
authorizes the practice of telemedicine in specified circumstances when 
no in-person medical evaluation has occurred. The Administrator of the 
Drug Enforcement Administration (DEA) (pursuant to delegation by the 
Attorney General) \1\ and the Substance Abuse and Mental Health 
Services Administration (on behalf of the Secretary of Health and Human 
Services (HHS) jointly issue this regulation and have each determined 
that this regulation is consistent with effective controls against 
diversion and with the public health and safety as required under 21 
U.S.C. 802(54)(G).
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    \1\ The Attorney General has delegated this authority to the 
Administrator of DEA under 28 CFR 0.100.
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    In March 2023, DEA published a notice of proposed rulemaking (NPRM) 
titled Expansion of Induction of Buprenorphine via Telemedicine 
Encounter.\2\ DEA and HHS are now finalizing the rule, with several 
modifications to the proposed provisions to address concerns brought 
forth by commenters. Under this final rule, a DEA-registered 
practitioner, prior to issuing a prescription via telemedicine for a 
schedule III-V controlled substance approved by the Food and Drug 
Administration (FDA) for use in the treatment of opioid use disorder 
(OUD),\3\ must review the prescription drug monitoring program (PDMP) 
data of the state in which the patient is located when the telemedicine 
encounter occurs, and the pharmacist must verify the identity of the 
patient \4\ prior to filling the prescription. The practitioner is 
authorized to prescribe up to an initial six-month supply (split 
amongst several prescriptions totaling six calendar months); additional 
prescriptions may be issued under other forms of telemedicine as 
authorized by the Controlled Substances Act (CSA) or after an in-person 
medical evaluation is conducted.
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    \2\ 88 FR 12890 (Mar. 1, 2023).
    \3\ Treatment of OUD means the use of effective FDA-approved 
medications including methadone, buprenorphine, and naltrexone to 
treat opioid use disorder. See NIDA. 2021, December 2. Overview. 
https://nida.nih.gov/publications/research-reports/medications-to-treat-opioid-addiction/overview. Last accessed on January 8, 2025.
    \4\ DEA understands there are situations where the patient (for 
whom the prescription was written) may not be the individual picking 
up the prescription at the pharmacy. In these situations, DEA defers 
to the definition of ``ultimate user'' as found in 21 U.S.C. 
802(27). As such, this regulation authorizes the pharmacist to 
verify the identity of the patient by accepting identification from 
any individual who falls under the definition of ``ultimate user'' 
prior to filling a prescription.
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    This final rule pertains to practitioners prescribing controlled 
substances to patients for the treatment of OUD in circumstances where 
the prescribing practitioner has not conducted an in-person medical 
evaluation of the patient prior to the issuance of the prescription. 
Therefore, it is important to emphasize that the limitations set forth 
in this final rule, and those associated with the ``practice of 
telemedicine'' as defined in 21 U.S.C. 802(54) generally, do not apply 
to practitioner-patient relationships in which there has already been a 
prior in-person medical evaluation of the patient by the prescribing 
practitioner.

II. Legal Authority and Background

    DEA implements and enforces the Comprehensive Drug Abuse Prevention 
and Control Act of 1970, often referred to as the CSA, and the 
Controlled Substances Import and Export Act, (21 U.S.C. 801-971), as 
amended. DEA publishes the implementing regulations for these statutes 
in 21 CFR parts 1300 through 1399. These regulations are designed to 
ensure a sufficient supply of controlled substances for medical, 
scientific, and other legitimate purposes, and to deter the diversion 
of controlled substances for illicit purposes.
    As mandated by the CSA, DEA establishes and maintains a closed 
system of control for manufacturing, distribution, and dispensing of 
controlled substances, and requires any person who manufactures, 
distributes, dispenses, imports, exports, or conducts research or 
chemical analysis with controlled substances to register with DEA, 
unless they meet an exemption, pursuant to 21 U.S.C. 822.\5\ The CSA 
further authorizes the Attorney General (and the Administrator of DEA 
by delegation through 28 CFR part 0) to promulgate regulations 
necessary and appropriate to execute the functions of

[[Page 6505]]

subchapter I (Control and Enforcement) and subchapter II (Import and 
Export) of the CSA.\6\
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    \5\ ``Dispense'' in the context of this rulemaking means to 
deliver a controlled substance to an ultimate user, which includes 
the prescribing of a controlled substance. 21 U.S.C 802(10).
    \6\ 21 U.S.C. 871(b), 958(f).
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The Ryan Haight Act

    The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 
(Ryan Haight Act) amended the CSA, in part, by adding several new 
provisions to prevent the illegal distribution and dispensing of 
controlled substances by means of the internet. The Ryan Haight Act 
generally requires that a practitioner conduct an in-person medical 
evaluation before issuing a prescription to a patient. This requirement 
is set forth in 21 U.S.C. 829(e), which provides that ``[n]o controlled 
substance that is a prescription drug as determined under the Federal 
Food, Drug, and Cosmetic Act may be . . . dispensed by means of the 
internet without a valid prescription.'' \7\ A ``valid prescription'' 
is defined as ``a prescription that is issued for a legitimate medical 
purpose in the usual course of professional practice by . . . a 
practitioner who has conducted at least 1 in-person medical evaluation 
of the patient.'' \8\ Section 829(e) further provides an exception to 
the in-person medical evaluation when a practitioner is ``engaged in 
practice of telemedicine.'' \9\ The practice of telemedicine is defined 
as ``the practice of medicine in accordance with applicable Federal and 
state laws by a practitioner (other than a pharmacist) who is at a 
location remote from the patient and is communicating with the patient, 
or health care professional who is treating the patient, using a 
telecommunications system \10\ referred to in section 1395m(m) of Title 
42.'' \11\
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    \7\ 21 U.S.C. 829(e)(1).
    \8\ Id. 829(e)(2)(A)(i).
    \9\ Id. 829(e)(3)(A).
    \10\ 42 U.S.C. 1395m(m) references, but does not define, such 
telecommunications systems. The Center for Medicare and Medicaid 
Services (CMS) promulgated regulations implementing these statutory 
provisions and define the term interactive telecommunications 
system. 42 CFR 410.78(a)(3) defines interactive telecommunications 
system as the multimedia communications equipment that includes, at 
a minimum, audio and video equipment permitting two-way, real-time 
interactive communication between the patient and distant site 
physician or practitioner. Interactive telecommunications system may 
also include two-way, real-time audio-only communication technology 
for any telehealth service furnished to a patient in their home if 
the distant site physician or practitioner is technically capable of 
using an interactive telecommunications system as defined in the 
previous sentence, but the patient is not capable of, or does not 
consent to, the use of video technology.
    \11\ 21 U.S.C. 802(54).
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    The Ryan Haight Act sets forth seven distinct categories in which a 
prescribing practitioner may engage in the practice of telemedicine 
even though no in-person medical evaluation has been conducted.\12\ In 
these circumstances, provided certain safeguards are in place to ensure 
that the practitioner who is engaged in the practice of telemedicine is 
able to conduct a bona fide medical evaluation of the patient at the 
remote location, and is otherwise acting in the usual course of 
professional practice, the Ryan Haight Act contemplates that the 
practitioner will be permitted to prescribe controlled substances via 
telemedicine encounters despite not having conducted an in-person 
medical evaluation prior to prescribing. Specifically, the last 
category provides that a telemedicine encounter may occur between the 
practitioner and the patient ``under any other circumstances that the 
Attorney General and the Secretary [of Health and Human Services] have 
jointly, by regulation, determined to be consistent with effective 
controls against diversion and otherwise consistent with the public 
health and safety.'' \13\
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    \12\ See 21 U.S.C. 802(54).
    \13\ Id. 802(54)(G).
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    As noted above, when practitioners engage in the practice of 
telemedicine, the practitioner must use ``a telecommunications system 
referred to in section 1395m(m) of Title 42.'' For purposes of section 
1395m(m), the Centers for Medicare and Medicaid Services (CMS) has 
defined ``interactive telecommunications system'' as multimedia 
communications equipment that includes, at a minimum, audio and video 
equipment permitting two-way, real-time interactive communication 
between the patient and distant site physician or practitioner. 
Interactive telecommunications system may also include two-way, real-
time audio-only communication technology for any telehealth service 
furnished to a patient in their home if the distant site physician or 
practitioner is technically capable of using an interactive 
telecommunications system as defined in the previous sentence, but the 
patient is not capable of, or does not consent to, the use of video 
technology.\14\ DEA and HHS are utilizing the aforementioned definition 
of ``interactive telecommunications system'' within this final rule.
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    \14\ 42 CFR 410.78(a)(3).
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COVID-19 Public Health Emergency

    In response to the COVID-19 Public Health Emergency (PHE), as 
declared by the Secretary of HHS on January 31, 2020, pursuant to the 
authority under section 319 of the Public Health Service Act (42 U.S.C. 
247),\15\ DEA granted temporary exceptions to the Ryan Haight Act and 
DEA's implementing regulations under 21 U.S.C. 802(54)(D), one of the 
seven distinct categories of telemedicine envisioned under the 
statutory definition of the practice of telemedicine. In order to 
prevent lapses in care, these exceptions authorized the prescribing of 
controlled-substance medications via telemedicine encounters even when 
the prescribing practitioner had not conducted an in-person medical 
evaluation of the patient. These telemedicine flexibilities authorized 
practitioners to prescribe schedule II-V controlled substances via 
audio-video telemedicine encounters, including schedule III-V 
controlled substances approved by the FDA for the treatment of OUD via 
audio-only telemedicine encounters. DEA granted the temporary 
exceptions to the Ryan Haight Act and DEA's implementing regulations 
via two letters published in March 2020:
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    \15\ Determination That a Public Health Emergency Exists, U.S. 
Department of Health and Human Services. https://aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx. Last accessed May 1, 2024.
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     A March 25, 2020 ``Dear Registrant'' letter signed by 
William T. McDermott, DEA's then-Assistant Administrator, Diversion 
Control Division (the McDermott Letter); \16\ and
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    \16\ William T. McDermott, DEA Dear Registrant letter, Drug 
Enforcement Administration (Mar. 25, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf.
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     A March 31, 2020 ``Dear Registrant'' letter signed by 
Thomas W. Prevoznik, DEA's then-Deputy Assistant Administrator, 
Diversion Control Division (the Prevoznik Letter).\17\
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    \17\ Thomas W. Prevoznik, DEA Dear Registrant letter, Drug 
Enforcement Administration (Mar. 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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Temporary Rules and Telemedicine Listening Sessions

    On May 10, 2023 DEA, jointly with HHS (with the Substance Abuse and 
Mental Health Services Administration (SAMHSA) acting on behalf of 
HHS), issued a temporary extension (First Temporary Rule) pursuant to 
21 U.S.C. 802(54)(G), which extended the full set of telemedicine 
flexibilities regarding the prescribing of controlled substances that 
had been in place under the COVID-19 PHE, through November 11, 
2023.\18\ On September 12 and 13, 2023,

[[Page 6506]]

DEA hosted live, in-person Telemedicine Listening Sessions, to receive 
additional input concerning the practice of telemedicine, namely, the 
advisability of permitting telemedicine prescribing of certain 
controlled substances without any in-person medical evaluation. 
Approximately 58 stakeholders, including DEA-registered institutional 
and individual practitioners, pharmacists, trade associations, state 
agencies, and other public interest groups, presented at the listening 
sessions. On October 10, 2023, DEA, jointly with HHS, issued a second 
temporary extension (Second Temporary Rule), also pursuant to 21 U.S.C. 
802(54)(G), thereby extending the full set of telemedicine 
flexibilities regarding prescription of controlled substances as were 
in place during the COVID-19 PHE through December 31, 2024.\19\ This 
extension authorized all DEA-registered practitioners to prescribe 
schedule II-V controlled substances via telemedicine through December 
31, 2024. On November 19, 2024, DEA, jointly with HHS, issued a third 
temporary extension (Third Temporary Rule) extending the current 
telemedicine flexibilities that have been in place since March 2020 
through December 31, 2025.\20\
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    \18\ Temporary Extension of COVID-19 Telemedicine Flexibilities 
for Prescription of Controlled Medications, 88 FR 30037 (May 10, 
2023).
    \19\ Second Temporary Extension of COVID-19 Telemedicine 
Flexibilities for Prescription of Controlled Medications, 88 FR 
69879 (Oct. 10, 2023).
    \20\ Third Temporary Extension of COVID-19 Telemedicine 
Flexibilities for Prescription of Controlled Medications, 89 FR 
91253 (Nov. 19, 2024).
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III. The Opioid Overdose Epidemic and Buprenorphine Use in Treating 
Opioid Use Disorder

    One way to assist individuals experiencing acute opioid withdrawal 
symptoms and seeking treatment for OUD is with the administration of 
certain narcotic controlled substances. The use of medications approved 
by the FDA for the treatment of OUD can effectively assist an 
individual in successfully recovering from opioid dependence. 
Currently, the only schedule III-V controlled substance narcotic drug 
approved by the FDA for the treatment of OUD is buprenorphine.\21\
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    \21\ 42 CFR 8.12(h)(2)(ii).
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    DEA classifies buprenorphine as a schedule III narcotic controlled 
substance because it has a currently accepted medical use in treatment, 
and has less potential for misuse than controlled substances in 
schedules I and II under the CSA.\22\ Buprenorphine is a long-acting 
partial opioid agonist. Its effects last for a longer period of time 
compared to a short-acting medication.\23\ For people who are not used 
to taking opioids, it can cause effects such as euphoria or respiratory 
depression, but these effects are weaker, and with less risk, including 
lower risk of overdose, than those caused by full opioid agonists such 
as heroin or fentanyl.\24\ When buprenorphine is taken as prescribed 
and at the appropriate dosage, it can significantly diminish cravings, 
lower physical dependence on other opioids, eliminate withdrawal 
symptoms, and reduce morbidity and cases of death from overdose.\25\ 
Buprenorphine is an effective medication for treating OUD, especially 
when used as part of a complete, individualized, treatment plan.
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    \22\ See 21 U.S.C. 812(b)(3)(A)-(C); 21 CFR 1308.13(e)(2)(i).
    \23\ Buprenorphine, Substance Abuse and Mental Health Services 
Administration. https://www.samhsa.gov/medications-substance-use-disorders/medications-counseling-related-conditions/buprenorphine. 
Last accessed Apr. 11, 2024.
    \24\ Id.
    \25\ Id.
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    However, because buprenorphine is itself an opioid, it can be 
misused or abused, and it should be used under the care of a 
practitioner to decrease the likelihood of diversion. As explained 
below, this final rule will expand access to OUD treatments by 
authorizing DEA-registered practitioners with schedule III-V authority 
the ability to prescribe schedule III-V controlled substances approved 
by the FDA for the treatment of OUD via audio-only telemedicine 
encounter, while also mitigating the risks of diversion.

A. The Opioid Overdose Epidemic and Treatments

    The estimated number of deaths from opioid overdoses for the 12-
month period ending in October 2023 was 79,695, with a peak of 83,985 
opioid overdose deaths in the 12-month period ending in May 2023.\26\ 
Although the opioid overdose epidemic has plagued the United States for 
many decades, overdose deaths have been attributed to ``several 
distinct waves'' beginning in the late 1990s with expanded opioid 
analgesic prescribing for pain; another wave following in 2010 
involving heroin; and a third wave began in 2013 related to illicit 
fentanyl, primarily illicitly made fentanyl \27\ The United States is 
currently experiencing a fourth wave related to rising polysubstance 
use and co-involvement of fentanyl and stimulant drugs such as 
methamphetamine.\28\
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    \26\ Provisional Drug Overdose Death Counts, National Center for 
Health Statistics, Centers for Disease Control and Prevention. 
https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. Updated 
Mar. 3, 2024. Last accessed Apr. 12, 2024.
    \27\ Opioid-Related Outcomes Among Individuals With Co-occurring 
Behavioral Health Conditions, National Quality Forum Final Report. 
https://www.qualityforum.org/Publications/2022/09/2022_Opioid_and_Behavioral_Health_Final_Report.aspx. Published 
September 26, 2022. Last accessed Apr. 12, 2024. See also `Fourth 
wave' of opioid epidemic crashes ashore, propelled by fentanyl and 
meth, Washington State Standard. https://washingtonstatestandard.com/2024/03/18/fourth-wave-of-opioid-epidemic-crashes-ashore-propelled-by-fentanyl-and-meth/. Published 
March 18, 2024. Last accessed Apr. 12, 2024.
    \28\ Ciccarone, D, The Rise of Illicit Fentanyls, Stimulants and 
the Fourth Wave of the Opioid Overdose Crisis, Curr Opin Psychiatry 
(July 1, 2021), The Rise of Illicit Fentanyls, Stimulants and the 
Fourth Wave of the Opioid Overdose Crisis--PMC. Last accessed Oct. 
28, 2024.
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    To combat substance abuse and assist individuals in receiving 
proper treatment, DEA published regulations in October 1974 to 
implement the Narcotic Addict Treatment Act of 1974 (NATA), authorizing 
practitioners to administer and dispense certain narcotic controlled 
substances, like methadone (schedule II) for detoxification treatment 
or maintenance treatment as long as the practitioners were separately 
registered as a narcotic treatment program (NTP or Opioid Treatment 
Program (OTP) as termed by SAMHSA).\29\ The Drug Addiction Treatment 
Act of 2000 (DATA) further expanded treatment options for OUD by 
authorizing physicians who met certain qualifications to treat OUD with 
FDA-approved medications, like buprenorphine, in treatment settings 
other than NTPs/OTPs.\30\ These DEA-registered practitioners became 
known as ``DATA-waived practitioners.'' Most recently, the Consolidated 
Appropriations Act, 2023 (CAA, 23) (Pub. L. 117-328) removed the DATA-
waiver requirement, expanding practitioner ability to prescribe 
buprenorphine.\31\ Under the CAA, DEA-registered practitioners with the 
authority to prescribe schedule III controlled substances can prescribe 
buprenorphine to their patients without needing a DATA waiver or having 
a limit or cap as to the number of patients they can treat.\32\
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    \29\ 37 FR 37986; see also 21 CFR 1306.07(a).
    \30\ Title XXXV of Public Law 106-310. DATA was subsequently 
amended in 2005 (Pub. L. 109-56), 2016 (sec. 303 of Title III of the 
Comprehensive Addiction and Recovery Act of 2016, Pub. L. 114-198) 
and in 2018 (sec. 3202 of the Substance Use-Disorder Prevention That 
Promotes Opioid Recovery and Treatment for Patients and Communities 
Act, Pub. L. 115-271).
    \31\ Section 1262 of Public Law 117-328.
    \32\ Id.

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[[Page 6507]]

B. Barriers To Access and Risk of Diversion of Buprenorphine

    Access to buprenorphine decreases the risk of opioid-related 
overdose.\33\ Increasing access to buprenorphine after a drug overdose 
has also been associated with a reduced risk of death.\34\ However, 
barriers to access remain. One study showed that of those Americans who 
likely would benefit from treatment for OUD, only 28% actually received 
such treatment.\35\ Another impediment occurs at pharmacies where 
pharmacists decline to fill buprenorphine prescriptions. For example, 
during the Telemedicine Listening Sessions, one speaker stated that 
pharmacies have sometimes declined to fill telemedicine prescriptions 
for buprenorphine, which they may perceive as inferior or suspect 
solely because the prescription was issued through telemedicine.\36\
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    \33\ Dadiomov, et al., Buprenorphine and naloxone access in 
pharmacies within high overdose areas of Los Angeles during the 
COVID-19 pandemic, Harm Reduction Journal (June 29, 2022). https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-022-00651-3. Last accessed Apr. 11, 2024.
    \34\ Larochelle, et al., Medication for Opioid Use Disorder 
After Nonfatal Opioid Overdose and Association With Mortality, 
Annals of Internal Medicine (Aug. 7, 2018), https://www.acpjournals.org/doi/10.7326/M17-3107. Last accessed Apr. 11, 
2024.
    \35\ Only one in Four People Needing Treatment for Opioid Use 
Disorder Received Medication, Columbia University School of Public 
Health (Mar. 23, 2022), https://www.publichealth.columbia.edu/public-health-now/news/only-one-four-people-needing-treatment-opioid-use-disorder-received-medication. Last accessed Apr. 11, 
2024.
    \36\ Telemedicine Listening Sessions, Dr. Juan Hincapie-Castillo 
(National Pain Advocacy Center), 173:7-13 (Sept. 13, 2023) 
(available: https://www.deadiversion.usdoj.gov/Telemedicine_listening_session.html).
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    Expanding the circumstances under which practitioners are 
authorized to prescribe buprenorphine via telemedicine encounters, 
including audio-only encounters, would increase access to treatment for 
those individuals with OUD who may not want to seek treatment, or are 
unable to seek treatment, due to various economic, geographical, 
sociological, and logistical reasons. Many patients may lack the 
financial means to obtain in-person treatment traditionally or through 
audio-video telemedicine encounters. Patients who are unhoused, 
unemployed, or facing other challenges may find it prohibitive to 
afford devices capable of audio-video telemedicine encounters or to 
find consistent access to wireless internet and/or data plans adequate 
to support bandwidth demands of audio-video telemedicine 
encounters.\37\
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    \37\ DeLaCruz et al., Telemental Health for the Homeless 
Population: Lessons Learned when Leveraging Care (December 8, 2022), 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9734763/.
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    This final rule authorizing audio-only telemedicine of 
buprenorphine in certain circumstances does not imply that 
buprenorphine cannot be, or is not, diverted. Some presenters spoke to 
these issues during the Telemedicine Listening Sessions. According to 
one presentation, there is a ``robust illicit market for 
buprenorphine,'' and patients may be selling buprenorphine to fund 
abuse of other controlled substances.\38\ Another presenter said that 
drugs that contain Suboxone[supreg], which contains buprenorphine \39\ 
prescribed to treat OUD, can be used as a ``currency'' to purchase 
other drugs like methamphetamine, adding that, in the individual's 
community, ``if [abuse or misuse of] methamphetamine is involved, you 
can pretty much be assured the diversion of buprenorphine is 
involved.'' \40\
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    \38\ Telemedicine Listening Sessions, Daniel Reck (Matclinics), 
104:3-9 (Sept. 12, 2023).
    \39\ Suboxone is a medication containing buprenorphine, and is a 
schedule III controlled substance. Buprenorphine, SAMHSA.gov, 
https://www.samhsa.gov/medications-substance-use-disorders/medications-counseling-related-conditions/buprenorphine. Last 
accessed Apr. 20, 2024.
    \40\ Telemedicine Listening Sessions, Jerome Cohan (Catalyst 
Health Solutions), 268:2-20 (Sept. 12, 2023).
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    Though, as with all transactions involving controlled substances, 
there is an inherent risk of diversion, DEA and HHS believe these 
regulatory provisions have been narrowly tailored to enable DEA and HHS 
to mitigate the risk of diversion associated with buprenorphine 
prescriptions issued pursuant to these new regulations. Moreover, 
considering the efficacy of treating OUD with buprenorphine when taken 
appropriately and subject to the additional safeguards in this rule, 
DEA and HHS believe that expanding access to buprenorphine through 
audio-only telemedicine outweighs the relatively lower risk of misuse 
and diversion of buprenorphine.

IV. Summary of Notice of Proposed Rulemaking

    DEA published an NPRM titled Expansion of Induction of 
Buprenorphine via Telemedicine Encounter, jointly with HHS, on March 1, 
2023.\41\ Within this NPRM, DEA and HHS proposed adding definitions for 
``prescription drug monitoring program'' and ``telemedicine 
encounter.'' This NPRM proposed to authorize practitioners to prescribe 
buprenorphine for maintenance treatment and detoxification treatment 
\42\ of OUD via telemedicine encounter, to include an audio-only 
telemedicine encounter, if all of the following certain conditions were 
met: (1) the practitioner would have needed to be registered under 21 
U.S.C. 823(g), see 21 CFR 1301.13(e)(1)(iv), in the state in which the 
practitioner was located; (2) the practitioner would have needed to be 
authorized by state law to engage in the practice of telemedicine in 
both the state where the practitioner is located and the patient is 
located; (3) the practitioner would have needed to be authorized under 
21 CFR 1301.28; and (4) the practitioner would have needed to be 
technologically capable of conducting a telemedicine encounter by using 
audio and video equipment. Prior to prescribing, the practitioner would 
have been required to review and consider the PDMP data of the state in 
which the patient is located regarding any controlled substance 
prescriptions issued to the patient in the last year, or if less than 
one year's worth of PDMP data was available, the entire available 
period.
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    \41\ 88 FR 12890 (Mar. 1, 2023).
    \42\ For the purposes of this rule, reference to treatment of 
OUD via telemedicine encounters refers to all stages of treatment of 
OUD, including ``maintenance treatment'' and ``detoxification 
treatment'' as defined under 21 U.S.C. 802(29)-(30).
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    The practitioner would have been required to review the PDMP data 
within seven days of the telemedicine encounter and would then have 
been authorized to prescribe an initial 30-day supply of schedule III-V 
buprenorphine-containing medication until a subsequent in-person 
medical evaluation of the patient had been conducted. Specifically, in 
order to prescribe more than a 30-day supply, the practitioner would 
have had three options as to how to conduct that subsequent in-person 
medical evaluation: (1) an in-person medical evaluation in which the 
patient would be in the physical presence of the prescribing 
practitioner; (2) an in-person medical evaluation in which the patient 
would be in the physical presence of a DEA-registered practitioner 
(other than the prescribing practitioner) and the two practitioners and 
patient were participating in a simultaneous real-time audio-video 
conference (``Telepresenter'' Model); or (3) an in-person medical 
evaluation would be conducted by a DEA-registered practitioner who then 
issued a written ``qualifying telemedicine referral'' for the patient 
to a prescribing practitioner before sharing an electronic medical 
record for the patient with the prescribing practitioner. Ultimately,

[[Page 6508]]

under any of these three pathways, the patient would have been required 
to be in the physical presence of a DEA-registered practitioner at some 
point to receive more than a 30-day supply of medication. Furthermore, 
additional recordkeeping requirements would have been mandatory if the 
medical evaluation occurred in the presence of another DEA-registered 
practitioner or through a qualifying telemedicine referral. For 
example, the prescribing practitioner would have been required to 
record whether the encounter was conducted via audio-video or audio-
only means and record the reason a patient chose an audio-only 
telemedicine encounter when applicable. The NPRM also would have 
required practitioners to maintain copies of all qualifying 
telemedicine referrals, if the referral pathway had been used to 
conduct the subsequent in-person medical evaluation. If the 
practitioner was unable to access the required PDMP data, the 
practitioner would have been authorized to issue a seven-day 
buprenorphine prescription and would have been required to record both 
the dates and times of any attempts to access the PDMP data, as well as 
why the practitioner was unable to access the PDMP data.

V. Summary of Changes From the NPRM

    After reviewing comments received in response to the NPRM, as will 
be discussed in more detail below, DEA and HHS have amended the 
requirements for this rulemaking. Most significantly, DEA and HHS have 
expanded the initial 30-day prescription supply limitation via audio-
only telemedicine to a six calendar month supply limitation. In 
addition, DEA is no longer amending 21 CFR part 1300 relating to 
definitions and part 1304 relating to records and reports of 
registrants. Specifically, DEA and HHS are no longer defining the terms 
``prescription drug monitoring program'' or ``telemedicine encounter'' 
that were found in the NPRM. DEA and HHS have also removed the 
requirement that in order to prescribe more than the initial supply of 
buprenorphine, an in-person medical evaluation of some sort must be 
conducted. In other words, DEA and HHS have removed the three options 
through which a subsequent in-person medical evaluation may be 
conducted and specified instead that continued prescribing may occur 
pursuant to other forms of the practice of telemedicine as defined in 
21 U.S.C. 802(54).
    In drafting the NPRM, DEA and HHS sought to ensure that patient 
access to buprenorphine via telemedicine encounters, including audio-
only telemedicine encounters, would still be authorized to continue 
once the COVID flexibilities ended, but also included additional 
requirements, not found within the flexibilities, to ensure that 
effective controls are in place to combat diversion. To this end, DEA 
and HHS created a framework under which specific types of in-person 
medical evaluations would have been required to be conducted after the 
initial 30-day prescription. However, a review of the comments 
persuaded DEA and HHS that the requirements found within the NPRM would 
be overly burdensome for the majority of patients, contradicting an 
important goal of this rulemaking. Therefore, in its place, DEA and HHS 
have expanded the 30-day supply limitation to an initial six-month 
prescription supply limitation, after which two options can be used by 
the practitioner in order to continue prescribing to the patient: (1) 
conduct an in-person medical evaluation as defined in 21 U.S.C. 
829(e)(2)(B); or (2) continue treating the patient via another form of 
telemedicine as defined in 21 U.S.C. 802(54). Since the supply 
limitation has been increased and a patient will not necessarily need 
to be seen in-person by the prescribing practitioner at any point, DEA 
and HHS have included an identification verification requirement, 
wherein the pharmacist must verify a patient's identity prior to 
filling a prescription issued under these regulations.
    Additionally, pursuant to this final rule, the practitioner will be 
required to review the PDMP data of the state in which the patient is 
located when the telemedicine evaluation occurred, prior to issuing a 
prescription. The practitioner will also be required to annotate the 
date and time that the PDMP was reviewed. If the PDMP is unavailable or 
inaccessible for any reason, the practitioner will be required to 
notate the date and time that such review was attempted and will be 
authorized to prescribe renewable seven-day prescriptions until the 
six-month limitation is reached; attempts must be made to review the 
PDMP every seven days in this situation. The remaining recordkeeping 
requirements from the NPRM, including maintaining a record of whether 
the encounter was conducted via audio-visual or audio-only means, why 
the patient chose an audio-only telemedicine encounter, and maintaining 
copies of all qualifying telemedicine referrals, have not been 
promulgated within the final rule.
    Lastly, DEA and HHS invited comments for any additional safeguards 
or flexibilities that should be considered with respect to the proposed 
regulatory changes. Based on comments received in response, and as 
noted above and discussed in more detail below, DEA and HHS are 
promulgating an additional provision which would require pharmacists to 
verify the identification of the patient receiving the prescription 
under this framework prior to dispensing the controlled substance 
medication.\43\
---------------------------------------------------------------------------

    \43\ 21 CFR 1306.51(b)(4).
---------------------------------------------------------------------------

VI. Discussion of Public Comments Received

    DEA and HHS received a total of 2,915 comments in response to the 
NPRM. Of those comments, 68 were intended for the separately published 
NPRM titled Telemedicine Prescribing of Controlled Substances When the 
Practitioner and the Patient Have Not Had a Prior In-Person Medical 
Evaluation \44\ and 178 were deemed outside the scope of the proposed 
rulemaking. As such, those comments will not be discussed further 
within this rulemaking. DEA and HHS received comments from 
practitioners, pharmacists, lawyers, professional associations, 
government entities, Tribal nations and associations, law firms and law 
school clinics, private companies, medical organizations, hospitals and 
medical practices, pharmacies, educational institutions, health 
insurance companies, and other members of the general public. DEA and 
HHS thank all commenters for their input during the rulemaking process.
---------------------------------------------------------------------------

    \44\ 88 FR 12875 (Mar. 1, 2023).
---------------------------------------------------------------------------

    All comments have been reviewed. DEA and HHS have grouped the 
comments into several distinct categories below in order to more easily 
summarize and respond to the large number of comments received in 
response to the NPRM. Of the comments received, some comments pertained 
to only one issue while others involved several issues.
In-Person Medical Examination Requirement
    Comment: DEA and HHS received the largest number of comments 
pertaining to the NPRM's proposed in-person medical evaluation 
requirement following the initial 30-day supply. Commenters raised 
several issues and concerns with this requirement. The following is a 
summary of the comments received. One thousand two hundred and eighty 
(1,280) commenters expressed concern that the proposed in-person 
medical evaluation requirement would be costly and/or time-prohibitive 
to patients. Commenters stated that the

[[Page 6509]]

in-person medical evaluation requirement created obstacles, such as: 
living in a rural area, work responsibilities or an inability to take 
leave from work, family and childcare obligations, and transportation 
issues. Three hundred and fifty-nine (359) commenters stated that the 
in-person medical evaluation requirement would result in a lack of care 
or reduced access to care because the in-person medical evaluation 
requirement would be a barrier to treatment. These commenters stated 
that patients may drop out of their treatment program and potentially 
relapse due to the in-person medical evaluation requirement potentially 
limiting access to buprenorphine via remote care. Two hundred and 
thirty (230) commenters stated that there still remains stigma within 
their community regarding OUD treatment and requiring patients to be 
seen in-person could expose them to harm, ``out them'' to the general 
public, and/or reduce their ability to keep their treatment private. 
Two hundred and seventeen (217) commenters expressed concern about a 
physical or mental hardship or risk potentially limiting their ability 
to fulfill an in-person medical evaluation requirement; these included 
mental health conditions such as agoraphobia, physical conditions, 
other conditions such as autism, and/or wanting to avoid interactions 
with other patients receiving OUD treatment out of concern that such 
interactions could increase the likelihood of a relapse. One hundred 
and twenty one (121) commenters stated that an evaluation conducted in-
person is generally the same as one conducted via a virtual appointment 
and there is no separate benefit in receiving a medical evaluation in-
person for purposes of OUD treatment. Sixty nine (69) commenters stated 
that an in-person medical evaluation requirement would have a disparate 
impact on or discriminate against certain persons, including those with 
disabilities, persons of color, American Indians/Alaska Natives, the 
elderly, and those recently incarcerated.
    Sixty seven (67) commenters stated that an in-person medical 
evaluation would be nearly impossible for them to schedule because of a 
general practitioner shortage and 44 commenters expressed the same 
concern because of a buprenorphine practitioner shortage within their 
geographic area. Fifty three (53) commenters, many of whom identified 
themselves as practitioners, stated that the decision to conduct or not 
conduct an in-person examination constitutes a clinical decision that 
should be left to the practitioner's discretion and therefore, there 
should be no in-person medical evaluation requirement imposed by 
regulation. Twenty two (22) commenters stated that in-person medical 
evaluations are rarely utilized for those receiving OUD treatment. One 
commenter stated that the Ryan Haight Act does not require an in-person 
medical evaluation, and if an in-person medical evaluation is required 
under the Ryan Haight Act, the in-person medical evaluation can be 
conducted by the prescribing practitioner or a practice group. Nine 
hundred and eleven (911) commenters expressed general disapproval of 
the in-person medical evaluation requirement.
    Response: DEA and HHS understand the many hardships an in-person 
medical evaluation requirement could cause patients and notes the 
multitude of reasons provided by commenters as to why this requirement 
would be burdensome to many patients. Therefore, DEA and HHS have 
expanded the initial prescription supply that may occur pursuant to 
audio-only telemedicine encounters from 30 days to six months. In 
addition, DEA and HHS have promulgated this final rule offering two 
options pursuant to which the prescribing practitioner is authorized to 
issue additional prescriptions for the treatment of OUD via 
telemedicine encounters subsequent to this initial six-month supply: 
(1) the practitioner can conduct an in-person medical evaluation; or 
(2) the practitioner can engage in other forms of the practice of 
telemedicine as defined in 21 U.S.C. 802(54). DEA and HHS believe this 
solution, which will allow subsequent prescribing pursuant to 
additional telemedicine pathways as DEA (and for rules that must be 
issued jointly, HHS) promulgate regulations permitting them, likely 
will further alleviate the various concerns raised by commenters as to 
the options for continued treatment.
    Comment: DEA and HHS received 11 comments agreeing with the 
inclusion of the in-person medical evaluation requirement. These 
commenters stated that the requirement is important because in-person 
medical evaluations prior to buprenorphine induction allow a 
practitioner to better determine the state of the patient and ensure 
the patient is not under the influence of any other substances.
    Response: DEA and HHS agree that an in-person medical evaluation 
provides a prescribing practitioner with valuable information about the 
patient that might not be fully discerned via a telemedicine encounter. 
The in-person medical evaluation allows a prescribing practitioner to 
conduct a thorough physical assessment of the patient, more accurately 
assess the patient's physical and mental health, and provides more 
accurate treatment options.\45\ Additionally, DEA and HHS believe an 
in-person medical evaluation can serve as an effective control against 
diversion by allowing the practitioner to better discern whether the 
medications the patient has been prescribed are working effectively and 
are being taken appropriately by the patient.\46\ However, DEA and HHS 
understand that not all patients are able to schedule and attend an in-
person medical evaluation. As mentioned above, given the unique 
circumstances of increasing access to potentially life-saving 
medications for the treatment of OUD during the overdose epidemic, DEA 
and HHS believe that removing the in-person medical evaluation 
requirement is appropriate in this situation. Therefore, within this 
final rule, DEA and HHS have provided the option for the practitioner 
to conduct an in-person medical evaluation; otherwise, practitioners 
are able to continue prescribing via other forms of telemedicine 
authorized under the CSA after the initial six-month prescription.
---------------------------------------------------------------------------

    \45\ K. Moulaei et al., Patients' perspectives and preferences 
toward telemedicine versus in-person visits: a mixed-methods study 
on 1226 patients (Nov. 15, 2023). https://www.ncbi.nlm.nih.gov/pmc/
articles/PMC10647122/
#:~:text=The%20primary%20reasons%20for%20selecting,better%20treatment
%20of%20the%20disease. Last accessed Aug. 5, 2024.
    \46\ Id.
---------------------------------------------------------------------------

In-Person Medical Evaluation Requirement Alternatives
    Comment: DEA and HHS received 144 total comments regarding the non-
traditional methods of fulfilling the in-person medical evaluation 
requirement,'' i.e., the Telepresenter Model or the qualifying 
telemedicine referral, listed within the NPRM. Seven comments addressed 
the Telepresenter Model, i.e., a scenario in which the patient attends 
an in-person medical evaluation in the physical presence of a DEA-
registered practitioner (other than the prescribing practitioner) and 
the two practitioners and patient participate in a simultaneous real-
time audio-video conference; 137 comments addressed the qualifying 
telemedicine referral model. For the Telepresenter Model, commenters 
expressed concern that this model also requires a substantial amount of 
travel (especially if the patient resides in a rural area); that it 
would be extremely difficult for the patient to try to coordinate the 
schedules of two practitioners; that these consults would be cumbersome

[[Page 6510]]

and unmanageable; that this model is not common practice in this type 
of medical care; and that getting an in-person appointment would be 
difficult especially for those who face stigma within their community 
for receiving OUD treatment. With regards to the qualifying 
telemedicine referral, the commenters stated that the referral process 
would be overly cumbersome and unnecessary; some practitioners may 
refuse to conduct an in-person medical evaluation for the purpose of 
issuing a referral; it takes too long to get a referral; some patients 
don't have medical insurance and requiring an in-person medical 
evaluation and a referral would not be possible; it is hard to make an 
in-person appointment with a primary care physician (PCP) as many 
people don't have PCPs; if a patient needs care from an addiction 
specialist the patient would need to wait for the referral before 
beginning treatment; and the referral process would be a barrier and 
diminish success of the treatment program.
    Response: DEA and HHS acknowledge that these non-traditional 
methods for fulfilling the in-person medical evaluation requirement may 
not represent feasible options for many patients. As noted above, DEA 
and HHS have removed both the Telepresenter Model and the qualifying 
telemedicine referral process from the final rule. DEA and HHS agree 
that, for many patients, these proposed provisions were not practicable 
and would create an undue burden on both patients and practitioners. 
After the initial six-month period, the option to conduct a traditional 
in-person medical evaluation remains should the practitioner and 
patient wish to continue treatment in such a manner.
30-Day Prescription Supply Limitation
    Comment: DEA and HHS received many comments related to the 30-day 
time period limitation. The comments asserting that 30 days was too 
short a time period in which to obtain an in-person medical evaluation 
are summarized in the above sections relating to in-person medical 
evaluations. DEA and HHS received a total of 68 comments related 
specifically to the 30-day prescription supply limitation. Some 
commenters stated that 30 days was too short a duration for 
buprenorphine dispensing before an in-person medical evaluation could 
be obtained, while other commenters generally supported the 30-day 
supply limitation. The commenters who believed 30 days was not enough 
time cited to various reasons: 10 commenters believed that the 30-day 
supply limitation was arbitrary and that it is not the typical length 
of prescription provided for OUD treatment; three commenters stated 
that 30 days represents insufficient supply and will interrupt a 
treatment regimen that has already been established; and one commenter 
stated the limit should be removed if the patient is clinically 
indicated for a buprenorphine prescription. 41 commenters stated there 
should be a prescription limitation but requested that the time period 
be increased from 30 days. Five commenters stated the supply limitation 
should be removed and prescriptions should be issued indefinitely; 
while two commenters stated that the prescribing practitioner should 
decide how long a prescription should be issued for.
    Four commenters expressed support for the 30-day supply limitation 
and indicated that 30 days was an appropriate time period. One of these 
commenters (a patient) stated they currently receive a 30-day supply of 
buprenorphine at a time and had no concerns with that limit. Two 
commenters indicated a 30-day supply prior to an in-person medical 
evaluation was too permissive: one commenter stated that after the 
initial 30-day supply, refills should only occur seven days at a time 
until an in-person medical evaluation could be obtained; and the other 
commenter stated that prescriptions should be restricted to three-to-
seven days for new patients with documentation that an in-person 
medical evaluation was not practical with one three-to-seven-day refill 
prescribed by a fully trained addiction physician. Additionally, some 
of these commenters asked clarifying questions about whether the 30-day 
supply limitation was only for a buprenorphine initiation period and 
not for every 30-day period of buprenorphine treatment, and also 
requested clarification about how the proposed regulations would have 
addressed a patient who started with a 30-day supply and then was 
``lost to follow-up'' but later re-engaged with treatment.
    Response: DEA and HHS acknowledge the commenters' concerns and 
agree that 30 days is too short of a timeframe to receive an initial 
buprenorphine prescription before being required to obtain an in-person 
medical evaluation to receive additional prescriptions. After reviewing 
the comments and feedback from the various listening sessions, DEA and 
HHS agree that many patients would have difficulty in scheduling an in-
person medical evaluation with a practitioner and/or specialist within 
a 30-day time period. At the same time however, DEA and HHS believe 
that prescriptions issued pursuant to audio-only telemedicine should 
not be issued indefinitely or solely at the discretion of the 
practitioner, given the increased risks of abuse, misuse, or other 
forms of diversion posed by audio-only telemedicine without a visual or 
in-person component. Several commenters suggested 180 days (six months) 
as a supply limitation before an in-person medical evaluation should be 
conducted. DEA and HHS agree and believe a six-month supply provides 
adequate time for a patient to be stabilized on medication via audio-
only medical encounter(s) without unduly increasing the risk of 
diversion. Therefore, the final rule allows for an initial prescription 
limitation of six calendar months after which time either an in-person 
medical evaluation must be conducted or the practitioner can continue 
prescribing via another form of telemedicine. DEA is also clarifying 
that the six-month (previously 30-day) supply limitation applies when 
the patient is treated by the same practitioner, regardless of when the 
six-month prescriptions are issued. For example, if a patient receives 
a prescription for a one-month supply three times by a practitioner, 
then stops treatment with that practitioner, the patient can only 
receive prescriptions for another three months of supply upon resuming 
treatment with that same practitioner, regardless of the reason 
treatment was stopped and time period that treatment was paused. Once 
an in-person medical evaluation has been conducted, the practitioner 
and patient are no longer engaged in the practice of telemedicine under 
21 U.S.C. 802(54) and are thus no longer bound to the requirements 
found within this rule.
Mandatory PDMP Review
    Comment: DEA received 30 comments opposing the mandatory PDMP 
review prior to issuing a buprenorphine prescription under this 
framework. These commenters, many of whom identified themselves as 
practitioners or as part of professional medical associations, stated 
that PDMP checks do not provide valuable information because they only 
show prescribed medications, not substances bought on the street 
illegally; state PDMPs do not all require practitioners to report the 
same medications (as which medications must be reported is based on 
state law); telehealth appointments are already limited in duration and 
valuable time would be spent by the practitioner reviewing the PDMP; 
DEA should defer to state law as to whether a PDMP check is required; 
patients

[[Page 6511]]

should not be penalized and limited to a seven-day supply if the PDMP 
is inaccessible or inoperable; practitioners may not have access to a 
state's PDMP; and the recordkeeping requirement associated with the 
PDMP review is too burdensome. Conversely, 15 commenters agreed with 
the PDMP requirement.
    Response: DEA and HHS believe it is essential for a practitioner to 
review the PDMP data for possible drug interactions and to discern 
whether there is any potential misuse or abuse of prescribed 
medications within a patient's history. PDMP reviews have been shown to 
combat the fraudulent prescribing of medications, reduce incidences of 
multiple overlapping prescriptions for the same controlled medications, 
known as doctor shopping, aid in the monitoring of controlled substance 
abuse and misuse, and help reduce drug-poisoning deaths.\47\ For these 
reasons, this final rule requires practitioners to review PDMP data 
prior to prescribing buprenorphine and restricts prescriptions to seven 
days at a time when the PDMP cannot be accessed. A review of PDMP laws 
and regulations of the 50 states, along with the District of Columbia, 
Guam, Puerto Rico, and the Northern Mariana Islands, shows that at 
least four states require a review of PDMP data prior to issuing any 
prescriptions and at least three states require the PDMP to be reviewed 
prior to issuing any telemedicine prescriptions. Further, 54 states/
territories require that buprenorphine prescriptions be reported to a 
PDMP and 48 states/territories require review of a patient's PDMP data 
prior to issuing a buprenorphine prescription. Since most states/
territories already have PDMP requirements, DEA and HHS believe this 
requirement poses a minimal administrative burden on practitioners, 
which are significantly outweighed by the benefits of reviewing this 
data.
---------------------------------------------------------------------------

    \47\ F. Alogaili et al., Prescription drug monitoring programs 
in the US: A systematic literature review on its strengths and 
weakness, Journal of Infection and Public Health (Sept. 30, 2020). 
https://www.sciencedirect.com/science/article/pii/S1876034120305657?via%3Dihub. Last accessed Aug. 5, 2024.
---------------------------------------------------------------------------

    As for recordkeeping requirements, this final rule will require 
practitioners to review the PDMP data and notate the date and time that 
such a review took place within the patient's electronic health record 
(EHR) or paper record. This notation will ensure that the prescribing 
practitioner has reviewed, or attempted to review, the PDMP prior to a 
prescription being issued. DEA and HHS understand that many EHR systems 
already contain this capability as this information is automatically 
integrated into the patient's record as soon as the data has been 
reviewed by the prescribing practitioner. If the PDMP data is 
inaccessible for any reason, the prescribing practitioner will be 
required to notate the date and time that such review was attempted, 
indicate why the PDMP was inaccessible, and will be limited to 
prescribing a seven-day supply. This seven-day supply can be renewed 
(up to six calendar months) if, every time the prescribing practitioner 
tries to review the PDMP data, the PDMP system is inoperable. While 
this is not meant to penalize either the practitioner or the patient, 
it should be a rare occurrence for a PDMP to be inaccessible for a full 
six-month time period. DEA and HHS believe the benefits of requiring a 
practitioner to review the patient's data for signs of abuse or misuse 
of controlled substances as soon as it becomes available outweigh any 
potential ``harms'' to the patient should the patient only receive an 
initial seven-day supply, especially since this seven-day supply can be 
renewed for up to six months.
Recordkeeping Requirements
    Comment: DEA and HHS received 105 comments voicing disapproval and 
eight comments supporting the recordkeeping requirements found within 
the NPRM. Specifically, 75 commenters stated the requirements were 
administratively burdensome, time consuming, and confusing; would cause 
delays in workflow and patient care; practitioners should not need to 
record why audio-only telemedicine was chosen; the NPI and registration 
number of practitioners should not be required to be recorded; and 
practitioners were uncomfortable recording their home or physical 
address.
    Twenty four (24) comments pertained to the requirement that the 
practitioner maintain a record that the encounter was conducted via 
audio-visual or audio-only means. Commenters indicated that this 
requirement would exacerbate the already common occurrence of 
pharmacies refusing to fill telemedicine prescriptions; there would be 
no clinical value; and it would create confusion. Six commenters asked 
for a 12-month grace period in order to update EHR systems to comply 
with the requirements.
    Response: DEA and HHS agree with the commenters who raised concern 
with the stated recordkeeping requirements and does not believe the 
requirements would fulfill their intended purpose. The majority of the 
recordkeeping requirements detailed within the NPRM therefore have been 
removed and the final rule contains only one recordkeeping requirement 
that pertains to the PDMP review (explained in the previous comment 
response). DEA and HHS believe the other safeguards found within this 
final rule will help to prevent diversion without being overly 
burdensome for either patients or practitioners. The prescribing 
practitioner will need to notate the date and time the PDMP review was 
conducted or, if such review could not be completed, the date and time 
the PDMP review was attempted and why the review could not be 
completed. As many EHR systems already have this functionality 
integrated within their systems, DEA and HHS do not believe additional 
time needs to be allocated in order to update systems or bring them 
into compliance with this requirement.
Diversion of Buprenorphine
    Comment: DEA and HHS received 791 comments regarding diversion of 
buprenorphine. Five hundred and twenty (520) commenters stated that the 
proposed rule would result in an increase of drug poisonings or 
overdoses due to patients having limited access to or losing access to 
their current buprenorphine treatment. One hundred and thirty five 
(135) commenters stated that there is no evidence to show that 
telemedicine care leads to higher diversion of buprenorphine than in-
person care and cited to studies concluding that the COVID-19 PHE 
flexibilities did not lead to higher diversion or misuse of 
buprenorphine. The remainder of the comments stated that if legitimate 
prescriptions were easier to obtain there would be less diversion; if 
buprenorphine is diverted, then it is diverted for therapeutic purposes 
or to mitigate withdrawal; the buprenorphine combination product with 
naloxone (Suboxone[supreg]) actually deters diversion and is harder to 
overdose on when misused because of its chemical makeup; and increasing 
access to buprenorphine should outweigh any potential harm from 
diversion. Twelve (12) commenters voiced approval for the rule and 
stated that diversion and overdoses of buprenorphine are of real 
concern and there is further cause for concern because for-profit 
telehealth companies or ``virtual pill mills'' have been expanding 
their buprenorphine business, which could lead to more diversion of the 
medication.
    Response: DEA and HHS understand that the COVID-19 PHE 
flexibilities have allowed for greater access to buprenorphine and it 
is DEA and HHS's

[[Page 6512]]

intention to continue expanding access to buprenorphine via 
telemedicine for patients who have a legitimate need for treatment as 
the flexibilities come to an end. DEA and HHS have relaxed many of the 
requirements found within the NPRM, in response to concerns raised by 
commenters that patients may have limited access or lose access to 
treatment otherwise.
    However, DEA has a mandate and commitment to detect and prevent the 
diversion of controlled substances, regardless of the reason for 
diversion, so DEA and HHS must nevertheless place certain safeguards on 
the telemedicine prescribing of buprenorphine. DEA and HHS note that 
several commenters expressed concern over buprenorphine diversion and 
the growth of ``virtual pill mill'' companies during the time the 
COVID-19 PHE flexibilities have been in place. Determining the reasons 
for diversion of buprenorphine in any particular case may prove 
difficult to discern, and a patient may divert buprenorphine for both 
claimed therapeutic and non-therapeutic purposes. Specifically, and as 
noted above, buprenorphine constitutes an effective treatment for OUD, 
but it can also create euphoric feelings similar in kind--even if not 
in intensity--to other opioid agonists. For these reasons, it is 
possible that some diverted buprenorphine might be used for reasons 
other than therapeutic purposes or mitigation of withdrawal. As the 
practice of telemedicine facilitates wider access to buprenorphine, DEA 
must ensure certain safeguards remain in place to deter potential 
diversion--whether for claimed therapeutic or non-therapeutic uses.
    DEA and HHS have promulgated this final rule taking into 
consideration the many concerns raised by the thousands of comments 
received in response to the NPRM. DEA and HHS have amended the 
requirements from the NPRM to the final rule in large part in response 
to the comments and concerns expressed by the public, and the data they 
have provided. The safeguards that are found within the final rule will 
continue to expand access to OUD treatment by allowing for 
buprenorphine treatment via audio-only encounters and will allow 
patients and practitioners to continue using telemedicine as a means of 
receiving treatment. The telemedicine flexibilities established during 
the COVID-19 PHE were intended to be temporary flexibilities during a 
time when in-person care was not universally routinely and safely 
available. The COVID-19 PHE flexibilities should not continue 
indefinitely at a time when receiving in-person care no longer poses a 
significant risk to public health and safety. This final rule 
acknowledges that telemedicine encounters are more flexible and 
convenient to many patients but also acknowledges that safeguards need 
to be in place to prevent misuse and abuse of controlled substances, 
especially during a time when an increasing number of for-profit 
telehealth companies continue to grow their practices without any 
permanent regulatory requirements or safeguards.
Additional Safeguards Requested by Commenters
    Comment: DEA and HHS received 41 comments requesting additional 
regulatory safeguards be put in place on top of the requirements 
already laid out in the NPRM. Commenters suggested requiring urine drug 
screens or blood tests, monthly pill counts, testing for alcohol use, 
psychological and physical monitoring, psychosocial support, and/or 
follow-up in-person medical evaluations every three months for the 
first year of treatment. Some commenters were in favor of buprenorphine 
prescribing via telehealth only if an in-person medical evaluation and 
drug screen were required while others believed that even with an in-
person medical evaluation and drug screen, buprenorphine should not be 
prescribed via telehealth encounter.
    Response: DEA and HHS acknowledge these concerns. As noted above 
the detection and prevention of diversion of buprenorphine is a 
significant priority of this rulemaking. At the same time, DEA and HHS 
understand that the addition of too many regulatory requirements may 
cause some patients to abandon their current OUD treatment or to 
decline to enter treatment in the first place. Within this rulemaking, 
DEA and HHS are attempting to continue to expand treatment options for 
OUD and make permanent some of the flexibilities permitted during the 
COVID-19 PHE. DEA and HHS are confident that the safeguards in place 
within this final rule will help alleviate diversion concerns while 
also allowing for patients to seek and obtain safe treatment for OUD.
    Additionally, as noted above, practitioners who have conducted an 
in-person medical evaluation of a patient are not required to adhere to 
the telemedicine requirements established by the Ryan-Haight Act when 
prescribing a controlled substance to that patient. More generally, 
those practitioner-patient relationships no longer constitute 
telemedicine as defined by the Ryan Haight Act and are outside the 
scope of this rulemaking.
DEA 823(g) Registration of Practitioners
    Comment: DEA and HHS received 18 comments regarding DEA 
registrations under 21 U.S.C. 823(g). Three commenters stated that a 
practitioner should only need one DEA registration and be legally 
authorized to practice telemedicine in the state in which the patient 
is located. Six commenters stated that the practitioner should only 
need to be DEA-registered and fully licensed in the state in which the 
patient is located. Two commenters stated that a practitioner should be 
able to prescribe controlled substances via telemedicine as long as 
they are licensed to practice medicine in the state the patient is 
located and that, furthermore, the practitioner should not also need a 
DEA registration for the state the patient is located in. Four 
commenters stated it was unclear if the NPRM was requiring that a 
practitioner needs a DEA registration in both the state in which the 
practitioner is located and state in which the patient is located. One 
commenter agreed generally with the NPRM and stated that telemedicine 
companies should be required to have a DEA registration in every state 
they want to prescribe. Two commenters requested an exception for 
separate DEA registrations for practitioners that have medical 
licensing reciprocity requirements.
    Response: DEA and HHS understand some confusion may have arisen 
from the NPRM regarding registration. As DEA has made clear elsewhere, 
under current statutes and regulations, practitioners are required, 
unless subject to an exception, to obtain a DEA registration both in 
the state in which the practitioner dispenses controlled substances and 
in the state in which the patient is located.\48\
---------------------------------------------------------------------------

    \48\ The CSA requires all practitioners to be registered in the 
state in which the patients to which they are prescribing controlled 
substances are located, regardless of whether the prescribing is 
taking place via telemedicine. The CSA provides that every person 
who dispenses, or who proposes to dispense, any controlled substance 
shall obtain from DEA a registration issued in accordance with DEA 
rules and regulations. See 21 U.S.C. 822(a)(2). Under the CSA, such 
dispensing includes prescribing and administering controlled 
substances. Id. 802(10). DEA may only register a person to dispense 
a controlled substance if that person is permitted to do so by the 
jurisdiction in which his or her patients are located. See id. 
802(21), 823(f). Thus, unless an applicable exception applies, DEA 
regulations require a practitioner to obtain a separate DEA 
registration in each state in which a patient to whom he or she 
prescribes a controlled substance is located when the prescription 
is made, regardless of whether the prescription is made via 
telemedicine. The CSA also contains provisions (added by the Ryan 
Haight Act) expressly requiring a practitioner to be registered in 
the state in which the patient to whom he is prescribing is located 
when he or she is engaged in certain forms of telemedicine. Under 
the CSA, a prescription for a controlled substance issued by means 
of the internet must generally be predicated on an in-person medical 
evaluation. See id. 829(e)(1). This requirement does not apply, 
however, when a practitioner is practicing telemedicine as defined 
by the CSA.

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[[Page 6513]]

Definitions
    Comment: DEA and HHS received 14 comments relating to definitions 
found within the NPRM. Seven commenters requested a definition of 
``mental health disorders'' be included in the rule; two commenters 
requested removal of the ``prognosis'' of OUD requirement as it relates 
to the qualifying telemedicine referral; two commenters requested a 
definition for ``telemedicine prescription''; two commenters requested 
amending the definition of ``patient's location''; and one commenter 
stated that DEA should not rely on the CMS definition of ``interactive 
telecommunications system.''
    Response: DEA and HHS have greatly simplified the final rule, which 
includes omitting any changes to current definitions within the Code of 
Federal Regulations. Additionally, as certain requirements from the 
NPRM have been removed, such as the qualifying telemedicine referral 
and the need for a notation on the telemedicine prescription, there is 
no need to provide definitions for those terms. DEA and HHS do not 
believe a definition for ``mental health disorders'' is needed as that 
question falls outside the scope of this rule. Furthermore, HHS 
regulations define the terms ``drug abuse'' and ``drug addiction'' in 
42 CFR 34.2(h) and (i) as ``current substance use disorder or 
substance-induced disorder, mild'' and ``current substance use disorder 
or substance-induced disorder, moderate to severe'', respectively, 
using the most recent edition of the Diagnostic and Statistical Manual 
for Mental Disorders. This rule authorizes the treatment of OUD through 
audio-only means solely to treat substance use disorders under this 
definition. The final rule also does not enact any regulations that 
explicitly require the ``patient's location'' to be disclosed, so no 
definition is needed. While DEA and HHS anticipate that many of these 
audio-only encounters will occur in a private setting, such as a 
patient's home, this rule is not placing any additional regulations or 
requirements upon the practitioner or the patient to verify the 
patient's location. DEA and HHS will continue to rely on the CMS 
definition of ``interactive telecommunications system'' within this 
rule, as the current definition of the term ``practice of 
telemedicine'' uses the CMS definition.\49\
---------------------------------------------------------------------------

    \49\ See 21 U.S.C. 802(54).
---------------------------------------------------------------------------

Rule's Applicability to Pharmacists
    Comment: DEA and HHS received seven comments related to the rule's 
applicability to pharmacists. Four commenters requested clarification 
as to whether DEA-registered pharmacists who are granted controlled 
substance prescriptive authority within their state would be allowed to 
prescribe and dispense medications under this rule, and whether they 
could conduct the in-person medical evaluation (or serve as the 
referring provider) under the framework proposed in the NPRM. 
Additionally, three commenters were concerned that the rulemaking would 
require pharmacists to ``police'' the practice of telemedicine, placing 
an undue burden on pharmacists and overwhelming pharmacy operations. 
These commenters expressed concern and sought clarity as to if, and 
how, a pharmacist would be required to verify that the in-person 
medical evaluation requirement had been fulfilled; how a pharmacist 
would discern which prescriptions are telemedicine prescriptions absent 
an indicator on the face of the prescription denoting it as such; and 
how a pharmacist would access or receive this information without 
violating the Health Insurance Portability and Accountability Act 
(HIPAA) and other patient privacy laws.
    Response: DEA and HHS understand the important role pharmacists 
play when they fill controlled substance prescriptions and appreciates 
the legitimate concerns raised by these comments. DEA and HHS are aware 
there still remains stigma associated with OUD treatment and has 
decided not to require a notation on the face of the prescription 
denoting that the prescription is one issued via telemedicine. DEA and 
HHS understand this may place more responsibility on a pharmacist and 
urges pharmacists to treat all buprenorphine prescriptions equally, 
while continuing to fulfill their longstanding corresponding 
responsibilities, without attempting to discern whether the 
prescription was issued via a telemedicine encounter. Pharmacists will 
not be required to access a patient's record to figure out whether the 
in-person medical evaluation has been conducted or whether an 
evaluation was completed via telemedicine. This rule is not intended to 
place pharmacists in the role of ``policing'' the practice of 
telemedicine, but rather reflects that pharmacists play an integral 
role in helping to prevent drug misuse. As set forth in 21 CFR 
1306.04(a), ``The responsibility for the proper prescribing and 
dispensing of controlled substances is upon the prescribing 
practitioner, but a corresponding responsibility rests with the 
pharmacist who fills the prescription.'' Therefore, the pharmacist will 
be required to verify the identity of the patient prior to filling a 
prescription. As explained in further detail below, many states already 
have placed on pharmacists an identification verification requirement 
for many controlled substances, including buprenorphine, as a matter of 
state law, and DEA and HHS believe placing an identity verification 
responsibility on pharmacists as a matter of Federal law generally 
should not represent an additional burden in the vast majority of 
cases.
Effective Date
    Comment: DEA and HHS received 43 comments solely concerned with the 
potential effective date of the final rule. Twenty (20) comments 
requested that the COVID-19 PHE flexibilities continue indefinitely for 
the duration of the ongoing opioid epidemic PHE; 19 commenters 
requested that the COVID flexibilities continue for six months after 
publication of the final rule, until the end of calendar year 2023, or 
until the end of calendar year 2024; and five commenters requested that 
the COVID flexibilities continue until the final rule is published.
    Response: The NPRM for this final rule was published on March 1, 
2023, and at the time the NPRM was published, the COVID-19 PHE 
flexibilities were set to expire on May 11, 2023. The COVID-19 PHE 
flexibilities have since been temporarily extended until December 31, 
2025, while DEA and, for rules that must be issued jointly, HHS have 
worked on other rulemakings. Once published, this final rule will be 
effective February 18, 2025. DEA and HHS believe this effective date, 
in concert with the latest extension of the telemedicine flexibilities, 
satisfies the concerns of those who commented on this issue.
Executive Order 12866--60 Day Comment Period
    Comment: DEA and HHS received nine comments stating that the 30-day 
comment period found within the NPRM violated Executive Order (E.O.) 
12866, which allegedly requires a 60-day comment period.
    Response: The language contained within E.O. 12866 states ``each 
agency should afford the public a meaningful opportunity to comment on 
any

[[Page 6514]]

proposed regulation, which in most cases should include a comment 
period of not less than 60 days.'' \50\ Since the 60-day comment period 
is not a requirement and because, at the time of publication of the 
NPRM, the COVID-19 PHE telemedicine flexibilities were set to expire on 
May 11, 2023, DEA chose to use a 30-day comment period to ensure all 
comments were received and to allow adequate time to publish a final 
rule.
---------------------------------------------------------------------------

    \50\ Executive Order 12866, Regulatory Planning and Review, 58 
FR 51735 (Oct. 4, 1993) (emphasis added).
---------------------------------------------------------------------------

Indian Tribes and Tribal Organizations
    Comment: DEA and HHS received two comments regarding the effect of 
this rulemaking on American Indian and Alaska Native (AI/AN) Tribes and 
Tribal organizations. One commenter requested an exemption from 
registration for all Indian Health Service (IHS) and Tribal health 
system and Indian Health Care providers.
    Both commenters indicated that consultation and coordination with 
Indian Tribes and Tribal organizations is required under Executive 
Order 13175 and requested that DEA meaningfully consult with Tribal 
officials prior to promulgating the final rule.
    Response: DEA and HHS thank these commenters for voicing their 
concerns. DEA held Telemedicine Listening Sessions on September 12 and 
13, 2023, and held Tribal Consultations with various Tribal governments 
and organizations on June 13 and 27, 2024. DEA and HHS have taken the 
opinions and concerns raised during both the listening sessions and 
consultations into account when promulgating this final rule. As such, 
DEA and HHS believe the requirements of Executive Order 13175 have been 
satisfied.
Other Comments
    Comment: One commenter asked for clarification on how patients in 
various stages of buprenorphine treatment would be impacted by the 
rule, given the rule's focus on ``induction'' of buprenorphine. The 
commenter stated that there are various stages of buprenorphine 
treatment, including: (1) patients being prescribed buprenorphine to 
initiate therapy (general understanding of ``induction''); (2) patients 
being re-established on buprenorphine treatment when previously 
prescribed the controlled substance medication; and (3) patients being 
moved from the ``induction'' phase to maintenance phase. The commenter 
sought clarification as to whether DEA intended to include all these 
stages under the proposed rule, and if not, the commenter asked that 
the rule allow buprenorphine at all stages of treatment.
    Response: Both the NPRM and this final rule are published with the 
intent of authorizing buprenorphine treatment via telemedicine. This 
final rule allows for any patient, beginning on February 18, 2025, to 
either begin treatment for OUD or continue treatment for OUD (i.e., all 
``stages'' of treatment) via audio-only telemedicine encounter if the 
requirements of 42 CFR 410.78(a)(3) are met. Beginning on this date, 
when a practitioner provides the patient with a prescription or 
prescription refill for buprenorphine as medication for OUD via 
telemedicine, the practitioner must review the PDMP prior to issuing 
the prescription. And the pharmacist, prior to filling the 
prescription, must verify the identity of the patient.
    Once the initial six-month supply has been prescribed, the 
practitioner and patient can choose to continue treatment either once 
an in-person medical evaluation has been conducted or through other 
forms of telemedicine pursuant to 21 U.S.C. 802(54). In other words, a 
patient has six months from the date a prescription (or prescription 
refill) has been issued pursuant to this final rule to either obtain an 
in-person medical evaluation or continue with another form of 
telemedicine.
    Comment: DEA and HHS received one comment stating DEA lacks the 
legal authority to limit telemedicine prescriptions to the FDA-approved 
indications contained in a medication's FDA-approved labeling. This 
commenter argued that DEA would effectively be attempting to define 
general standards of accepted medical practice, a power which is 
usually reserved for states.
    Response: DEA and HHS, jointly, have the legal authority to 
promulgate regulations regarding the practice of telemedicine that are 
consistent with the public health and safety.\51\ DEA reiterates that 
practitioners who are otherwise authorized under state and Federal law 
(including under the Ryan Haight Act) might prescribe buprenorphine for 
indications other than for treatment of OUD. This final rule only 
applies to circumstances where the prescribing practitioner has not 
conducted an in-person medical evaluation of the patient and is 
otherwise unable to prescribe buprenorphine while engaged in the 
practice of telemedicine under 21 U.S.C. 802(54) but for the authority 
provided in this final rule.
---------------------------------------------------------------------------

    \51\ See 21 U.S.C. 821, 21 U.S.C. 871, and 21 U.S.C. 802(54)(G).
---------------------------------------------------------------------------

    Comment: One commenter stated that DEA should hold an annual review 
of the efficacy and burden of the in-person medical evaluation 
requirement and this review should be published in the Federal 
Register.
    Response: DEA appreciates this comment and will take this 
recommendation under consideration and advisement; however, no 
definitive response can be provided on this issue at this time.

VII. Provisions of the Final Rule

    Under this final rule, a DEA-registered practitioner may prescribe 
buprenorphine via audio-only or audio-video telemedicine encounter as 
defined by 42 CFR 410.78(a)(3). After a practitioner reviews the PDMP 
data for the state in which the patient is located and annotates in the 
patient's EHR that such a review was conducted, the practitioner may 
prescribe an initial six-month supply of buprenorphine. DEA and HHS 
expect that the practitioner will not issue the six-month prescription 
at one time but will rather issue prescriptions as medically 
appropriate. Following the initial six-month supply, practitioners may 
prescribe buprenorphine only by other forms of telemedicine or 
practices authorized by the CSA, or after conducting an in-person 
medical examination. Additionally, prior to dispensing under this 
framework, the pharmacist will need to verify the identity of the 
patient \52\ with either a state or Federal Government-issued 
photographic identification card or other form of identification.
---------------------------------------------------------------------------

    \52\ As noted previously, DEA understands there are situations 
where the patient (for whom the prescription was written) may not be 
the individual picking up the prescription at the pharmacy. In these 
situations, DEA defers to the definition of ``ultimate user'' as 
found in 21 U.S.C. 802(27). As such, this regulation authorizes the 
pharmacist to verify the identity of the patient by accepting 
identification from any individual who falls under the definition of 
``ultimate user'' prior to filling a prescription.
---------------------------------------------------------------------------

A. Prescription Drug Monitoring Program Check by Prescribing 
Practitioner

    The regulation at 21 CFR 1306.51(b)(1), found within this final 
rule, provides that the prescribing practitioner must review the PDMP 
data of the state in which the patient is located. The prescribing 
practitioner will then need to ensure that the date and time of the 
PDMP review is annotated in the patient's EHR or paper record. If, for 
any reason, the PDMP is unavailable or inaccessible and the

[[Page 6515]]

practitioner is unable to review the PDMP data for the patient, the 
prescribing practitioner should annotate in the patient's EHR the 
reason such a review was unable to be completed.
1. If PDMP Data Can Be Reviewed
    Prior to prescribing buprenorphine to the patient, the practitioner 
will be required to review the PDMP data of the state in which the 
patient is located and ensure that the date and time of such review is 
annotated in the patient's EHR or paper record. The prescribing 
practitioner will be required to review the PDMP data for the last 
year, or if less than one year's worth of data is available, for the 
entire period. The inclusion of this requirement prior to prescribing 
is to ensure that the practitioner has the information needed in order 
to make the clinical decision of whether or not to prescribe 
buprenorphine to a patient under this framework. Inherent in the 
telemedicine context, and especially through audio-only means, there 
may be situations where it is difficult for a practitioner to ascertain 
if a patient is being truthful about their medical history and prior 
usage of controlled substances. The requirement of a mandatory PDMP 
review can furnish the prescribing practitioner with valuable 
information regarding a patient's controlled substance prescription 
history, and by using their own clinical judgment, the practitioner can 
make an informed decision.
    Regarding the date and time requirement, DEA and HHS understand 
that many EHR systems already integrate state PDMP data into their 
systems. For these systems, a date and time stamp recording when a 
prescribing practitioner reviews PDMP data should be automatically 
integrated into the patient's EHR. For other EHR systems where only the 
date of PDMP access is integrated into the patient's EHR or no 
integrations exist at all, the prescribing practitioner will be 
required to manually input the date and time the PDMP review was 
conducted prior to closing or signing off on a patient's chart. DEA and 
HHS understand this may be burdensome to practitioners but DEA and HHS 
are confident that as technology changes, many EHR systems will likely 
update their platforms to enable automatic integration.
2. If PDMP Data Cannot Be Reviewed
    The regulation at 21 CFR 1306.51(b)(3) provides that if, for any 
reason, the PDMP data cannot be reviewed for a patient, the prescribing 
practitioner should ensure that the reason for this is noted in the 
patient's EHR or paper record. For example, if a state PDMP is 
inaccessible or unavailable due to technological issues, the 
prescribing practitioner should note the date and time that an attempt 
to view such data was made. In these situations, when PDMP data cannot 
be reviewed, a practitioner would only be permitted to prescribe an 
initial seven-day supply of buprenorphine. The practitioner may not 
prescribe an additional supply without again checking the PDMP data for 
that patient. However, the practitioner would be authorized to issue 
additional limited seven-day supply prescriptions (up until the six-
calendar month limitation is reached) if the PDMP remained unavailable 
or inaccessible, as long as each time a review is attempted, the date 
and time of each attempt is annotated in the patient's EHR or paper 
record.

B. Time Limitation of Buprenorphine Prescriptions

    The regulation at 21 CFR 1306.51(b)(2) provides that buprenorphine 
prescriptions issued pursuant to audio-visual or audio-only 
telemedicine encounters are limited to a period ending no later than 
six calendar months after the date of the first prescription. This six-
month supply must be split across multiple prescriptions or refills as 
the practitioner deems medically appropriate. Subsequent prescriptions 
may be issued once the practitioner has met with the patient for a 
follow-up evaluation either through any other form of telemedicine as 
defined in 21 U.S.C. 802(54) or through an in-person examination of the 
patient by the prescribing practitioner. Additionally, this requirement 
would comport with the current regulations found in 21 CFR 1306.22(a) 
regarding refilling of prescriptions for controlled substances listed 
in schedule III or IV.
1. Other Authorized Forms of Telemedicine or Practices Established by 
Regulation
    After an initial six-month prescription of buprenorphine via audio-
visual or audio-only means, additional prescriptions may be written 
pursuant to any other form of telemedicine as defined in 21 U.S.C. 
802(54). This includes the regulations found within any final rule that 
may be issued setting forth a special registration framework. In the 
event DEA issues future regulations setting forth practices DEA 
determines to be consistent with effective controls against diversion, 
pursuant to 21 U.S.C. 829(e)(3)(B), additional prescriptions would also 
be permitted to be issued pursuant to those practices.\53\
---------------------------------------------------------------------------

    \53\ No such practices have yet been determined by future DEA 
regulation to be consistent with effective controls against 
diversion.
---------------------------------------------------------------------------

2. In-Person Medical Evaluation
    Practitioners who conduct an in-person medical evaluation of a 
patient subsequent to the initial six-month supply restriction would, 
from that point on, no longer be required to adhere to the telemedicine 
requirements established by the Ryan-Haight Act for that patient. As 
explained above, this rulemaking contemplates situations only wherein 
the prescribing practitioner has never conducted an in-person 
examination. Once an in-person examination has been conducted by the 
prescribing practitioner, the duties and obligations found within this 
final rule no longer apply.

C. ID Requirement for Pharmacists

    Under new 21 CFR 1306.51(b)(4), prior to filling a prescription 
that was issued pursuant to the authorities created by this final rule, 
the pharmacist will be required to verify that, as a general matter, 
the identity of the individual picking up the prescription at the 
pharmacy matches the name of the patient listed on the prescription 
itself.\54\ Before the pharmacist can fill a prescription issued 
pursuant to the regulations found in this final rule, they must inspect 
the patient's state or Federal Government-issued photographic 
identification card, or in the absence of such identification, any 
other form of documentation showing that the patient is the same person 
as the patient listed on the prescription. The form of identification 
presented need not contain the patient's address. Such forms of 
identification include, but are not limited to: state issued driver's 
licenses and identification cards; U.S. passport; U.S. military card or 
military dependent's identification card; Native American tribal 
documents; paycheck; bank or credit card statement; utility bill; tax 
bill; or voter registration card. For minors under the age of 18, 
unhoused persons, and those without photographic identification, 
examples of other permissible forms of identification include: school 
transcripts; school

[[Page 6516]]

report cards; or a letter from a homeless shelter employee or a letter 
from a Tribal government official or other Tribal leader verifying the 
identity of the patient. As indicated, the acceptable forms of 
identification provided as examples within this final rule are not 
intended to be an exhaustive list.
---------------------------------------------------------------------------

    \54\ As noted previously, DEA understands there are situations 
where the patient (for whom the prescription was written) may not be 
the individual picking up the prescription at the pharmacy. In these 
situations, DEA defers to the definition of ``ultimate user'' as 
found in 21 U.S.C. 802(27). As such, this regulation authorizes the 
pharmacist to verify the identity of the patient by accepting 
identification from any individual who falls under the definition of 
an ``ultimate user'' prior to filling a prescription.
---------------------------------------------------------------------------

    As mentioned above, even absent the ID provision, DEA and HHS 
believe that the requirements as proposed in the NPRM and modified as a 
result of public comment and promulgated herein would be sufficient to 
mitigate and provide effective controls against diversion under this 
framework. As a result of the Telemedicine Listening Sessions, DEA's 
survey of state law, input received from public comments, and DEA's 
collaboration with HHS, DEA and HHS are promulgating 21 CFR 
1306.51(b)(4) as an additional layer of protection against diversion. 
In sum, verifying the identity of the patient prior to dispensing is 
intended to ensure that the individual who is receiving the controlled 
substance medication from the pharmacist is the same individual for 
whom the prescription was issued.
    During the Telemedicine Listening Sessions, seven presenters spoke 
on the importance of verifying a patient's identification prior to 
dispensing a controlled substance. Many of these presenters, who are 
practitioners themselves, indicated they already require a valid form 
of identification during a telemedicine encounter and require patients 
to provide proof of identification prior to prescribing. The 
practitioners subsequently keep a record of that identification. These 
presenters emphasized this policy helps to prevent illegal access to 
and misuse of medication. Since DEA and HHS believe that many 
prescribers already require proof of identification during the 
telemedicine encounter itself and since practitioners will be required 
to review PDMP data, DEA and HHS have promulgated this identification 
verification requirement for the pharmacist to provide an extra layer 
of protection against diversion by ensuring the prescription is being 
dispensed to the patient for whom the prescription was issued.
    DEA and HHS further believe this requirement is a codification of 
widely employed current practice, as many state laws currently require 
pharmacists to verify the identity of the patient prior to dispensing. 
DEA conducted a review of the laws and regulations of all 50 states 
along with the District of Columbia and found that there are currently 
43 states that have an identification requirement placed on pharmacists 
prior to filling a prescription. The situations in which identification 
verification is required varies: some states require verification 
outright, some states indicate that the pharmacist ``may'' verify 
identification, and some states only require verification if the 
patient is ``unknown'' to the pharmacist. Additionally, states vary as 
to what medications require verification: some states only require it 
for schedule II controlled substances, some for controlled substances 
found within schedules II-V, and some for ephedrine or pseudoephedrine 
products or precursors. Since several states already impose 
identification verification requirements on pharmacists, DEA and HHS do 
not believe imposing this requirement on buprenorphine prescriptions 
will create an undue burden on pharmacists. Additionally, as DEA and 
HHS are not requiring government-issued photo identification, DEA and 
HHS believe providing the pharmacist with any documentation that 
sufficiently verifies identity will not be a burden on patients. Even 
though some states do not have statutes which mirror this new 
provision, DEA and HHS believe this provision largely codifies existing 
practice and assists in mitigating the risk of diversion.
    DEA and HHS have thus chosen to include this requirement in the 
context of schedule III-V prescriptions for the treatment of OUD issued 
pursuant to this final rule, which permits prescriptions based on 
audio-only telemedicine encounters, in order to assist in reducing the 
risk of unauthorized individuals diverting buprenorphine for illicit 
purposes. DEA and HHS believe this additional layer of protection will 
help curtail any potential diversion. This identification requirement 
will help ensure that the patient using the buprenorphine prescription 
picked up at the pharmacy is the same patient that received the 
buprenorphine prescription from the audio-only telemedicine 
encounter.\55\
---------------------------------------------------------------------------

    \55\ As noted previously, DEA understands there are situations 
where the patient (for whom the prescription was written) may not be 
the individual picking up the prescription at the pharmacy. In these 
situations, DEA defers to the definition of ``ultimate user'' as 
found in 21 U.S.C. 802(27). As such, this regulation authorizes the 
pharmacist to verify the identity of the patient by accepting 
identification from any individual who falls under the definition of 
an ``ultimate user'' prior to filling a prescription.
---------------------------------------------------------------------------

    Should the identification requirements described in 21 CFR 
1306.51(b)(4), or 42 CFR 12.3(b)(4), be held to be invalid or 
unenforceable as applied to any person or circumstance, or stayed 
pending agency action, it shall be construed so as to continue to give 
the maximum effect to the provision permitted by law, including as 
applied to persons not similarly situated or to dissimilar 
circumstances, unless such holding is that the identification 
requirements described in 21 CFR 1306.51(b)(4), or 42 CFR 12.3(b)(4), 
are invalid and unenforceable in all circumstances, in which event 21 
CFR 1306.51(b)(4) and 42 CFR 12.3(b)(4), shall be severable from the 
remainder of 21 CFR 1306.51(b) and 42 CFR 12.3(b).

D. Scope-Clarifying Provisions

    The three remaining provisions of 21 CFR 1306.51 serve to clarify 
the scope of the final rule. The regulation at 21 CFR 1306.51(b)(5) 
provides that this final rule only applies to prescriptions issued for 
the treatment of OUD, even if the schedule III-V controlled substance 
approved by the FDA for use in the treatment of OUD also has other 
medical uses; for example, there are drugs containing buprenorphine 
that have been approved by the FDA to treat acute moderate-to-severe 
pain.\56\ Though buprenorphine-containing drugs have other FDA-approved 
uses, the intention of this paragraph, and this final rule writ large, 
is to increase patient access to buprenorphine for the treatment of 
OUD. The regulation at 21 CFR 1306.51(b)(6) makes explicit that this 
final rule only applies to practitioners who are already registered, or 
otherwise exempt from registration, to dispense buprenorphine.
---------------------------------------------------------------------------

    \56\ Poliwoda, et al. Buprenorphine and its formulations: a 
comprehensive review. Health Psychology Research. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9392838/. Published Aug. 20, 
2022. Last accessed Ap. 20, 2024.
---------------------------------------------------------------------------

    Finally, 21 CFR 1306.51(b)(7) provides that prescriptions issued 
pursuant to this final rule must otherwise comply with relevant DEA 
regulations. For example, a prescription issued under this final rule 
must be dated and signed and must include the patient's name and 
address, the name, strength, dosage, form and quantity of the drug, 
directions for use, and the practitioner's name, address, and DEA 
registration number of the practitioner.\57\
---------------------------------------------------------------------------

    \57\ 21 CFR. 1306.05(a).
---------------------------------------------------------------------------

VIII. Regulatory Analyses

Executive Orders 12866, 13563, and 14094 (Regulatory Review)

    DEA and HHS have determined that this rulemaking is a ``significant 
regulatory action'' under section 3(f) of Executive Order 12866, 
Regulatory Planning and Review, but it is not a section 3(f)(1) 
significant action. Accordingly, this final rule has been

[[Page 6517]]

submitted to the Office of Management and Budget (OMB) for review. This 
final rule has been drafted and reviewed in accordance with Executive 
Order 12866, ``Regulatory Planning and Review,'' section 1(b), 
Principles of Regulation; Executive Order 13563, ``Improving Regulation 
and Regulatory Review,'' section 1(b), General Principles of 
Regulation; and Executive Order 14094, ``Modernizing Regulatory 
Review.''
    DEA and HHS are amending their regulations to expand the 
circumstances under which DEA-registered practitioners are authorized 
to prescribe schedule III-V controlled substances approved by the FDA 
for the treatment of OUD via a telemedicine encounter, including an 
audio-only telemedicine encounter. Under these new regulations, after a 
prescribing practitioner reviews the patient's state PDMP data, the 
practitioner can prescribe an initial six-month prescription (split 
amongst several prescriptions totaling six calendar months) of such 
medications through audio-only means. This final rule does not affect 
practitioner-patient relationships in cases where an in-person medical 
evaluation has previously occurred.
Number of Telemedicine Encounters, Providers, and Patients
    The number of telemedicine encounters, including audio-only 
telemedicine, leading to buprenorphine prescriptions under the 
temporary guidance during the COVID-19 PHE forms the basis for 
estimating the number of audio-only telemedicine encounters pursuant to 
this final rule.
    Based on CMS claims data provided by the Department of Health & 
Human Services Office of Inspector General (HHS OIG), from March 2020, 
the start of the COVID-19 health emergency shutdowns, to December 2021, 
24,285 Medicare fee-for-service and managed care telemedicine services 
were identified as being linked to buprenorphine Part D prescription 
fills.\58\ These telemedicine services were rendered by 7,733 providers 
to 15,521 patients.\59\ Of the 24,285 matching telemedicine services, 
3,083 were billed with audio-only procedure codes, rendered by 1,806 
providers to 2,548 patients.\60\
---------------------------------------------------------------------------

    \58\ ``Monthly summary of telemedicine visits matched to a 
subsequent buprenorphine prescription between March 2020 and 
December 2021'', HHS OIG, Mar. 2022.
    \59\ Ibid.
    \60\ HHS OIG analyzed telemedicine billing codes and patient 
information to identify telemedicine visits within a 48-hour period 
prior to a buprenorphine prescription fill associated with the same 
patient, and where the prescribing provider is the same as or 
related to the billing or rendering provider of the telemedicine 
visit.
---------------------------------------------------------------------------

    Based on the CMS data, the telemedicine services and associated 
buprenorphine prescriptions identified spiked at the beginning of the 
COVID-19 PHE and stayed relatively steady in 2021. Therefore, 2021 data 
is used to estimate the number of telemedicine encounters for this 
analysis.
    In 2021, there were a total of 1,929,151 Part D buprenorphine 
prescriptions associated with 1,332,353 beneficiaries.\61\ Over the 
same period, there were 11,956 telemedicine Medicare fee-for-service 
and managed care telemedicine services, including audio-only 
telemedicine, identified as being linked to buprenorphine Part D 
prescriptions fills.\62\ These telemedicine services were provided by 
4,533 providers to 8,182 patients.\63\ The 1,929,151 Part D 
buprenorphine claims associated with 1,332,353 beneficiaries equates to 
a ratio of 1.45 \64\ claims per beneficiary. Therefore, the 11,956 
services represent an estimated 8,257 (11,956/1.45) initial 
prescriptions, which equates to 0.428 percent (8,257/1,929,151) of 
total Part D claims for buprenorphine (1,929,151 total claims). Based 
on IQVIA data, the total number of new prescriptions for buprenorphine 
in the U.S. in 2021 was 15,782,652.\65\ Applying the telemedicine share 
of total Part D buprenorphine prescriptions to the estimated number of 
total services associated with a buprenorphine prescription yields an 
estimated 67,552 (0.428 percent x 15,782,652) initial prescriptions. 
DEA and HHS believe this is a high estimate, as the telemedicine share 
of total Part D buprenorphine prescriptions may include telemedicine 
services allowed by regulation prior to the PHE.
---------------------------------------------------------------------------

    \61\ Id.
    \62\ Id.
    \63\ HHS OIG, May 2022.
    \64\ Numbers shown are rounded for presentation and clarity. 
Calculations using the provided numbers may not yield the same 
results due to this rounding.
    \65\ IQVIA, National Prescription Audit, September 2022.
---------------------------------------------------------------------------

Affected Persons
    This final rule would affect practitioners prescribing schedule 
III-V controlled substances for the treatment of OUD using audio-video 
or audio-only technology and the patients being treated using this 
technology. Based on the analysis above, DEA and HHS expect the final 
rule to affect 67,552 patients annually. As previously discussed, in 
2021, 8,182 patients received a prescription for buprenorphine under 
the Medicare Part D program, from 4,533 providers, equating to a ratio 
of approximately 1.80 patients per provider. Applying this ratio to the 
number of affected patients, DEA and HHS estimate 37,425 providers are 
affected by this final rule.
Impact on Physicians or Practitioners
    The final rule would permit the use of audio-video or audio-only 
telemedicine provided that (1) the DEA-registered practitioner meets 
all requisite state and Federal registration requirements for both 
prescribing of controlled substances and engaging in the practice of 
telemedicine, (2) reviews state PDMP data regarding any controlled 
substance prescriptions issued to the patient and annotates this within 
the patient's EHR, (3) is limited to prescribing a six-month supply, 
across all such prescriptions, until the practitioner conducts an in-
person medical evaluation or engages in other forms of authorized 
telemedicine, and (4) the pharmacist filling the prescription confirms 
the patient identity using a valid government-issued ID or other 
acceptable form of identification. Below is the analysis of the four 
requirements stated above:

1. DEA Registration Requirement: DEA and HHS assume all practitioners 
who would issue prescriptions via telemedicine encounters pursuant to 
this final rule are authorized under DEA regulations under 21 CFR 
1301.13(e)(1)(iv) as well as the states where the practitioner is 
located (unless otherwise excepted). Therefore, the impact of this 
requirement is minimal.

    2. Review PDMP data and annotate within the EHR: Based on a 2018 
study, it takes a practitioner 27 seconds to log in and 37 seconds to 
retrieve a report once logged in. The total time it takes to retrieve a 
PDMP report is roughly a minute (27 + 37 = 64 seconds) or 0.0167 of an 
hour (1/60).\66\ Based on an estimated loaded hourly rate of 
$169.80,\67\ the cost of a review of the

[[Page 6518]]

PDMP is $2.83 ($169.80 x 0.0167). Applying this cost to 67,552 
services, the total cost of PDMP review is $191,171 ($2.83 x 67,552), 
annually.\68\ While many practitioners already check PDMP data prior to 
issuing a prescription for controlled substances for a variety of 
reasons, DEA and HHS will consider the full cost of checking the PDMP, 
$191,171, as a cost of this final rule to be conservative.
---------------------------------------------------------------------------

    \66\ Bachhuber MA, Saloner B, LaRochelle M, Merlin JS, Maughan 
BC, Polsky D, Shaparin N, Murphy SM. Physician Time Burden 
Associated with Querying Prescription Drug Monitoring Programs. Pain 
Med. 2018 Oct.
    \67\ For the purpose of this analysis, the cost per registrant 
is estimated by multiplying the loaded labor rate by the estimated 
time to complete the review. The loaded labor rate is based on the 
estimated loaded hourly wage for 29-1229, Physicians, all other. 
Bureau of Labor Statistics, Occupational Employment and Wages, May 
2023, https://www.bls.gov/oes/current/oes291229.htm. The average 
hourly wage is $119.54, with benefits estimated at an additional 
42.05% of the base wage. The load factor is calculated by comparing 
the benefits for private workers as a share of wages, 29.6%/70.4% = 
42.05%. Bureau of Labor Statistics, Employer Costs for Employee 
Compensation--December 2023, https://www.bls.gov/news.release/archives/ecec_03132024.pdf. The loaded wage was therefore $119.54 x 
1.4205 = $169.80 per hour for private physicians, all other.
    \68\ Numbers shown are rounded for presentation and clarity. 
Calculations using the provided numbers may not yield exactly the 
same results due to this rounding
---------------------------------------------------------------------------

    3. Limited to a six-month supply: Increasing the limit to a six-
month supply under this final rule will give patients and prescribing 
practitioners more time to schedule follow-up appointments and reduce 
the likelihood of a relapse by a patient due to lack of medication, and 
will allow prescribing practitioners greater flexibility in managing 
their patient populations. While DEA and HHS do not have a basis to 
quantify the economic impact of the six-month supply limit, six months 
of medication for treatment is believed to be a net benefit compared to 
a baseline of zero to seven days of medication for treatment.
    4. Pharmacist ID verification: Pharmacists must verify the 
patient's identity with either a state or Federal Government-issued 
photographic identification card, or another acceptable form of 
identification as listed above. The practice of checking identification 
when providing prescriptions is already well-established and 
widespread, and DEA expects any additional labor costs for pharmacists 
to be minimal.
    In summary, the total cost to practitioners is $191,171 annually, 
which is the cost associated with checking PDMPs.
Impact on Patients
    As discussed earlier, DEA and HHS estimate this final rule will 
affect 67,552 patients per year. DEA and HHS anticipate that patients 
will fall into one of two categories:
    (1) Patients who would otherwise not receive treatment or 
prescriptions for OUD absent this final rule. These patients have no 
other means to receive treatment. They are unable to visit a 
practitioner in-person or otherwise visit a practitioner engaged in the 
practice of telemedicine as defined in 21 CFR 1300.04(i), but are able 
to have an audio-video or audio-only telemedicine visit pursuant to 
this final rule.
    (2) Patients who would eventually receive treatment and 
prescriptions even absent the final rule. These patients are able to 
either visit a practitioner in-person or have a telemedicine visit with 
a practitioner engaged in the practice of telemedicine as defined in 21 
CFR 1300.04(i); however, such visit is delayed for any variety of 
reasons, e.g., long wait times for an appointment with the 
practitioner, personal hardship, etc. This final rule, if implemented, 
would create additional flexibilities, potentially allowing the patient 
to more quickly start treatment, absent this final rule.
    DEA and HHS do not have a basis to estimate how many of the 
estimated 67,552 patients fall into the two groups. However, DEA and 
HHS anticipate a larger impact for the first group. The impact on the 
first group of patients is a result of receiving treatment for OUD. 
There would be a cost of treatment and the benefit generated from the 
treatment, which would not have been possible without this final rule. 
The impact on the second group would be the result of receiving 
treatment sooner than they would have without this final rule. For both 
groups, the impact could potentially be lifesaving. However, DEA and 
HHS do not have access to data that would permit them to estimate the 
number of lives the improved access could save. There would be a cost 
of treatment and the benefit of earlier treatment, including potential 
cost-offsets associated with reduced healthcare and public safety 
expenditures. According to a December 2021 research report, treatment 
costs with buprenorphine for a stable patient provided in a certified 
Opioid Treatment Program, including medication and twice-weekly visits, 
were $115 per week or $5,980 per year.\69\ This is likely higher than 
the cost of treating a stable patient in a primary care setting, where 
patients are more likely to see providers once per week and where there 
are no associated specialized costs. However, using the $5,980 per year 
estimate serves to establish an upper boundary for potential costs in 
any cost-benefit comparison. Estimates of the impact of buprenorphine 
use in the treatment of OUD suggests a 23.7% decrease in total deaths, 
and 31.2% reduction in drug poisonings (both fatal and nonfatal). In 
total, the combined cost-savings of buprenorphine (including both 
health-care costs as well as criminal justice costs) was estimated by 
one study at $60,000 per person.\70\ At the costs listed above, the 
savings from the treatment of one person would cover the cost of 
buprenorphine treatment for ten others.
---------------------------------------------------------------------------

    \69\ How much does opioid treatment cost?, NIDA. (Apr. 13, 
2021), https://nida.nih.gov/publications/research-reports/medications-to-treat-opioid-addiction/how-much-does-opioid-treatment-cost.
    \70\ Fairley et al.. Cost-effectiveness of Treatments for Opioid 
Use Disorder. JAMA Psychiatry (July 1, 2021).
---------------------------------------------------------------------------

    A study published in 2021 of the societal costs for OUD found that 
the ``costs for opioid use disorder and fatal opioid overdose in 2017 
were estimated to be $1.02 trillion. 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.'' \71\ According 
to the report, in 2017 total non-fatal costs were $471 billion and 
total fatal costs were $550 billion and there were 2.1 million persons 
ages 12 years and older with OUD, and 47,000 fatal opioid 
overdoses.\72\ 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. Dividing the 
total non-fatal cost of $471 billion by the number of persons ages 12 
and older with OUD of 2.1 million, the societal cost of non-fatal OUD 
is approximately $224,000 ($471 billion/2.1 million) per person per 
year. While DEA and HHS are unable to quantify how many of the affected 
patients will be successfully treated for OUD or how many fatal opioid 
overdoses will be avoided as a result of this final rule, the potential 
economic benefit is disproportionally large compared to any cost 
associated with this rule.
---------------------------------------------------------------------------

    \71\ Florence C, Luo F, Rice K. The economic burden of opioid 
use disorder and fatal opioid overdose in the United States, 2017. 
Drug Alcohol Depend. 2021;218:108350. doi:10.1016/
j.drugalcdep.2020.108350.
    \72\ Id.
---------------------------------------------------------------------------

Risk of Diversion
    This final rule will reduce the requirements imposed on 
practitioners who wish to prescribe schedule III-V controlled 
substances as part of treatment for OUD. DEA and HHS understand that 
there is potential for the misuse of controlled substances approved for 
OUD treatment, which could be worsened by an increase in prescribing.
    While this final rule may increase the risk of diversion, with the 
safeguards, DEA and HHS estimate this increased risk will be minimal. 
Requirements to check the state PDMP prior to issuance of a 
prescription, in-person requirements for follow-up

[[Page 6519]]

appointments under current law, and the requirement that pharmacists 
verify identification prior to filling a prescription are expected to 
minimize the diversion of buprenorphine via telemedicine, including 
audio-only telemedicine. Practitioners already have the authority to 
prescribe buprenorphine. Studies have found that, in 2019, the 
percentage of buprenorphine misuse among adults with past-year use was 
29.2%. Of those adults who misused buprenorphine in a previous year, 
71.8%-74.7% did not have their own prescription.\73\ Given the misuse 
of buprenorphine is often for self-treatment of OUD symptoms, these 
numbers underscore the need for expanded access to buprenorphine 
treatment for OUD.
---------------------------------------------------------------------------

    \73\ Han, Beth et al. ``Trends in and Characteristics of 
Buprenorphine Misuse Among Adults in the US.'' JAMA Netw Open. 2021 
Oct 1; 4(10):e2129409. Accessed 9/15/2022.
---------------------------------------------------------------------------

    The growth of waivers to prescribe buprenorphine was slower among 
prescribers working in small nonmetropolitan counties than urban 
counties. Prescribers in rural counties were associated with low 
buprenorphine dispensing.\74\ DEA and HHS believe that by providing 
increased access for rural areas, the benefits of increasing access to 
buprenorphine outweigh any added risk of diversion as the result of 
this rule.
---------------------------------------------------------------------------

    \74\ Id.
---------------------------------------------------------------------------

Other Potential Costs
    DEA and HHS also examined the cost of technology, both capital 
investment and operation expenses, in order to provide audio-only 
telemedicine in compliance with the final rule. DEA and HHS believe 
that the use of telemedicine will not require any additional capital 
expenditures on the part of practitioners or patients. Recordkeeping 
requirements are likely to have a minimal impact because current 
recordkeeping practices are likely to meet the requirements imposed by 
the final rule, and any additional time is expected to be minimal. EHRs 
may be updated in the future to reflect the final rule change, such as 
the integration of state PDMP data into a patient's EHR, but such 
changes are likely to be minor and included as part of any normal 
software update.
Summary
    In summary, DEA and HHS estimate this rule would affect 37,425 
providers and 67,552 patients, annually. DEA and HHS believe that this 
rule would increase patient access to buprenorphine for two types of 
patients: those who otherwise would be unable or unwilling to seek 
treatment, as well as those who would seek treatment but with some form 
of delay. Increased access to buprenorphine is expected to reduce the 
number of opioid drug poisonings annually, however, DEA and HHS cannot 
quantify the size or total benefits of such a reduction. There would be 
a slight increase in labor costs per practitioner, due to increased 
time spent reviewing PDMP databases. The estimated total cost to the 
37,425 providers is $191,171 annually. DEA and HHS estimate 
recordkeeping requirements are likely to have a minimal impact because 
current recordkeeping practices are likely to meet the requirements 
imposed by this final rule, and any additional time is expected to be 
minimal. The increase in the availability and flexibility of treatment 
with schedule III-V controlled substances may increase the risk of 
diversion, however DEA and HHS believe that any increase would be small 
and outweighed by the benefit to patients and reduction in the societal 
cost of OUD.

Executive Order 12988, Civil Justice Reform

    This final rule meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors 
and ambiguity, minimize litigation, provide a clear legal standard for 
affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

    This final rule does not have federalism implications warranting 
the application of E.O. 13132. The final rule does not have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    DEA and HHS are committed to the principles of collaboration and 
consultation with Tribal governments, as demonstrated through its plans 
to conduct the appropriate Executive Order 13175 Tribal consultations 
and recognizes the significance of these consultations and their role 
in shaping regulations that impact Tribal communities. DEA and HHS have 
determined that there is a reasonable basis to believe that this rule 
may have Tribal implications, consistent with the definition in 
Executive Order 13175.
    On June 13 and 27, 2024, DEA held virtual consultations with 
numerous Tribal governments and organizations. DEA and HHS considered 
the valuable insights from Tribal persons and organizations received 
during the comment period of the Buprenorphine NPRM from March 2023 (88 
FR 12890), the Telemedicine Listening Sessions held in September 2023, 
and the most recent virtual consultations from June 2024. DEA's 
intentions have been to engage in consultations as appropriate 
throughout the rulemaking process, fostering a collaborative 
environment that respects the sovereignty and interests of Tribal 
governments, while enhancing the overall quality and effectiveness of 
DEA's regulatory efforts. As such, DEA and HHS have incorporated these 
concerns, as necessary, within this final rule to ensure DEA and HHS's 
regulations align with the diverse needs and considerations of various 
stakeholders impacted by DEA oversight.

Regulatory Flexibility Act

    The Administrator and the Secretary, in accordance with the 
Regulatory Flexibility Act (5 U.S.C. 601-612) (RFA), have reviewed this 
proposed rule and by approving it certifies that it will not have a 
significant economic impact on a substantial number of small entities.
    Due to the COVID-19 PHE, DEA issued guidance which authorized 
prescribing of 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.\75\ To continue the flexibilities of audio-only telemedicine 
prescribing of schedule III-V controlled substances approved by the FDA 
for the treatment of OUD beyond the COVID-19 PHE, DEA and HHS have 
promulgated regulations which would balance the need to increase 
patient access to legitimate medical treatment with the goal of 
providing effective controls against diversion. Thus, within this final 
rule, DEA and HHS are explaining the conditions in which a practitioner 
is authorized to prescribe buprenorphine via an audio-only telemedicine 
encounter, and the obligations which arise once a practitioner 
prescribes to patients.
---------------------------------------------------------------------------

    \75\ Prevoznik Letter.
---------------------------------------------------------------------------

Affected Persons
    This final rule affects DEA-registered practitioners prescribing 
schedule III-V controlled substances for the treatment of OUD via 
telemedicine, including audio-only telemedicine. As stated

[[Page 6520]]

above, DEA and HHS estimate this final rule will affect 37,425 DEA-
registered practitioners and 67,552 patients annually. Because patients 
are individuals and not small entities, this analysis examines the 
impact of the final rule on affected practitioners and small entities 
that employ the affected practitioners.
    With respect to practitioners, this final rule would permit the use 
of audio-only telemedicine provided that the practitioner (1) meets all 
requisite state and Federal registration requirements for both 
prescribing of controlled substances and engaging in the practice of 
telemedicine, (2) reviews PDMP data regarding any controlled substance 
prescriptions issued to the patient in the previous year, and (3) is 
limited to prescribing a six-month supply, across all such 
prescriptions, until the practitioner conducts an in-person medical 
evaluation or engages in other forms of telemedicine.
    A significant number of practitioners work in offices and 
institutions that meet the RFA's definition of small entities. To 
estimate the number of affected entities, DEA and HHS first determined 
the North American Industry Classification System (NAICS) codes that 
most closely represent businesses that would employ the practitioners 
who would prescribe buprenorphine via an audio-only telemedicine 
encounter. Then, DEA and HHS researched economic data for those codes. 
The source of the economic data is the Small Business Administration 
(SBA) Office of Advocacy, and is based on data provided by the U.S. 
Census Bureau Statistics of U.S. Businesses (SUSB).\76\ The following 
business NAICS codes are estimated to represent businesses that employ 
the affected persons:
---------------------------------------------------------------------------

    \76\ SUSB's employer data contain the number of firms, number of 
establishments, employment, and annual payroll for employment size 
of firm categories by location and industry. A ``firm'' is defined 
as an aggregation of all establishments owned by a parent company 
(within a geographic location and/or industry) with some annual 
payroll. Small Business Administration, Firm Size Data, https://www.sba.gov/advocacy/firm-size-data (last visited Apr 25, 2024). The 
data table is available at https://www.sba.gov/sites/default/files/files/static_us_11.xls (last visited April 25, 2024).

 621111--Offices of Physicians, Except Mental Health 
Specialists
 621112--Offices of Physicians, Mental Health Specialists
 621420--Outpatient Mental Health and Substance Abuse Centers
 622110--General Medical and Surgical Hospitals
 622210--Psychiatric and Substance Abuse Hospitals

    SUSB data contains the number of firms by size ranges for each of 
the NAICS codes. For the purposes of this analysis, the term ``firm'' 
as defined in the SUSB is used interchangeably with ``entity'' as 
defined in the RFA.
    To estimate the number of affected entities that are small 
entities, DEA and HHS compared the SUSB data for the number of firms in 
various firm size ranges with SBA size standards for each of the 
representative NAICS codes. The SBA size standard is the firm size 
based on the number of employees or annual receipts depending on 
industry. The SBA size standards for NAICS codes 621111, 621112, 
621420, 622110, and 622210 are annual receipts of $14 million, $12 
million, $16.5 million, $41.5 million, and $41.5 million, respectively.
    The firms in each size range below the SBA size standard are small 
firms. The number of firms below the SBA size standard was added to 
determine the total number of small firms in each NAICS code. DEA and 
HHS estimate there are 161,286, 10,561, 6,523, 2,560, and 396 entities 
in the 621111, 621112, 621420, 622110, and 622210 industries. Based on 
the SUSB data on the firm sizes, DEA and HHS estimate there are 
157,060, 10,392, 5,849, 1,047, and 204 small entities in the 621111, 
621112, 621420, 622110, and 622210 industries. In total, DEA and HHS 
estimate there are 181,326 entities in the three potentially affected 
industries, of which 174,552 (96.3 percent) are small entities. The 
analysis is summarized in table 1 below.

                             Table 1--Number of Affected Entities and Small Entities
----------------------------------------------------------------------------------------------------------------
                                                                     Number of       SBA size        Number of
                           NAICS code                                  firms       standard  ($)   small firms *
----------------------------------------------------------------------------------------------------------------
621111--Offices of Physicians, Excepting Mental Health                   161,286      14,000,000         157,060
 Specialists....................................................
621112--Offices of Physicians, Mental Health Specialists........          10,561      12,000,000          10,392
621420--Outpatient Mental Health and Substance Abuse Centers....           6,523      16,500,000           5,849
622110--General Medical and Surgical Hospitals..................           2,560      41,500,000           1,047
622210--Psychiatric and Substance Abuse Hospitals...............             396      41,500,000             204
                                                                 -----------------------------------------------
    Total.......................................................         181,326  ..............         174,552
    Percent of Total............................................  ..............  ..............           96.3%
----------------------------------------------------------------------------------------------------------------
* Not all decimal places shown.

    From above, E.O. 12866 section, DEA and HHS estimate that audio-
only telemedicine services will be provided by 37,425 providers to 
67,552 patients, annually. Therefore, this final rule is estimated to 
affect 37,425 individual practitioners employed by some of the 174,552 
small businesses in industries potentially affected by this final rule. 
Since some small entities will employ more than one practitioner, the 
number of affected small entities is expected to be less than 37,425 
and is expected to be concentrated in the 621111, 621112, and 621420 
industries, with a combined total of 173,301 small entities. Therefore, 
the number of small entities affected by this final rule is estimated 
to be approximately 21.6%, which is a substantial number of the 
representative industries.
    The cost of the final rule will impact the affected entities and 
small entities on a ``per person'' basis. Rather than estimating the 
number of practitioners per firm, then the cost per firm, then whether 
the cost is significant, DEA and HHS employed a more direct approach 
based on the following logic:
     In order to continue, the affected firms must generate 
enough revenue to pay the wages of practitioners, and other operating 
expenses.
     Therefore, revenue for firms must be greater than the 
wages paid to practitioners.
     Therefore, if the cost of the final rule is not 
economically significant when compared to individual wages for 
practitioners, the cost of the final rule is not economically 
significant when

[[Page 6521]]

compared to the annual revenue of the firms.
    From 2021 data provided by CMS, DEA and HHS estimate that 67,552 
patients received telemedicine services prior to receiving a 
prescription for buprenorphine. These services were provided by 37,425 
separate providers, for approximately 1.8 \77\ patients per provider.
---------------------------------------------------------------------------

    \77\ Numbers shown are rounded for presentation and clarity. 
Calculations using the provided numbers may not yield exactly the 
same results due to this rounding
---------------------------------------------------------------------------

    DEA and HHS estimate a non-loaded median hourly wage of $119.54 
\78\ and $62.11 \79\ for potentially affected physicians and MLPs, 
respectively. Applying the hourly wage rates to the estimated time to 
apply, DEA and HHS estimate the labor cost per PDMP review is $1.99 
($119.54 x 1/60) and $1.04 ($62.11 x 1/60) per physician and MLP, 
respectively. The non-loaded wage rates are calculated to represent the 
cost to the individual, whereas previously the loaded wage rates were 
calculated to represent the total cost of employment to the entity and 
to the economy. These rates are multiplied by 1.8 patients, for total 
labor costs of $3.59 and $1.88, respectively.
---------------------------------------------------------------------------

    \78\ Bureau of Labor Statistics, Occupational and Employment and 
Wages, May 2023, 29-1229 Physicians, All Others, http://www.bls.gov/oes/current/oes291229.htm.
    \79\ Bureau of Labor Statistics, Occupational and Employment and 
Wages, May 2023, 29-1071 Physician Assistants, http://www.bls.gov/oes/current/oes291071.htm. Bureau of Labor Statistics, Occupational 
and Employment and Wages, May 2023, 29-1171 Nurse Practitioners, 
http://www.bls.gov/oes/current/oes291171.htm. DEA calculated the 
weighted average hourly wage based on the distribution of physician 
assistants (36.2%) and nurse practitioners (63.8%).
---------------------------------------------------------------------------

    The loaded unit cost of conducting a PDMP review is compared to the 
non-loaded annual wage rate for practitioners. Based on the Bureau of 
Labor Statistics' (``BLS'') Occupational and Employment and Wages data, 
DEA and HHS estimate an average annual wage of $248,640 for physicians 
and $118,553 for MLPs. Unit costs of $3.59 and $1.88 represent 0.001 
0.002 percent of those wages. Table 2 presents the details of the 
calculation.

                                                       Table 2--Costs and Fees as Percent of Wages
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                            Additional
                                                            Mean hourly   Time to review     Cost per      Cost per 1.8     Mean annual      costs as
                                                             wage ($)         (hours)       patient ($)    patients ($)      wage ($)       percent of
                                                                                                                                             wage (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physicians..............................................          119.54          0.0167            1.99            3.59         248,640           0.001
MLP.....................................................           62.11          0.0167            1.04            1.88         118,553           0.002
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The economic impact of additional time spent conducting PDMP 
reviews represents a small fraction (0.001 and 0.002 percent) of annual 
wages. DEA and HHS estimate this final rule will not have a significant 
economic impact on individual practitioners. The entities and small 
entities that employ the potentially affected practitioners are 
expected to generate enough revenue to pay their wages.
    In addition to DEA-registered prescribers detailed above, the 
proposed rule would require pharmacists to verify the identification of 
any person receiving a prescription for Buprenorphine via an audio-only 
telemedicine visit. Identity verification is already a common practice 
and DEA believes that this would not impose any significant additional 
time or labor costs to the actions of pharmacist registrants. 
Therefore, DEA and HHS conclude this final rule will not have a 
significant economic impact on a substantial number of small entities.

Unfunded Mandates Reform Act of 1995

    The estimated annual impact of this rule is minimal. Thus, DEA and 
HHS have determined in accordance with the Unfunded Mandates Reform Act 
of 1995 (UMRA) (2 U.S.C. 1501 et seq.) that this action would not 
result in any Federal mandate that may result in the expenditure by 
State, local, and Tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted for inflation) in any 
one year. Therefore, neither a Small Government Agency Plan nor any 
other action is required under provisions of UMRA.

Congressional Review Act

    Pursuant to subtitle E of the Small Business Regulatory Enforcement 
Fairness Act of 1996 (also known as the Congressional Review Act), the 
Office of Information and Regulatory Affairs has determined that this 
rule does not meet the criteria set forth in 5 U.S.C. 804(2).

Paperwork Reduction Act of 1995

    This final rule is finalizing a new collection of information under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501-3521. As required 
under PRA, DEA proposed the creation of a new collection of information 
in the NPRM, which OMB assigned the following control number: 1117-NEW. 
An agency may not conduct or sponsor, and a person is not required to 
respond to a collection of information unless it displays a valid OMB 
control number. Copies of existing information collections approved by 
OMB may be obtained at http://www.reginfo.gov/public/do/PRAMain.
A. Collections of Information Associated With the Final Rule
    1. Title: Recordkeeping Related to PDMP.
    OMB Control Number: 1117-NEW.
    Form Number: N/A.
    DEA and HHS are amending their regulations by authorizing 
initiation of schedule III-V controlled medications approved for use in 
the treatment of OUD via telemedicine encounter, to include audio-only 
means. Prior to prescribing, the practitioner must review the PDMP data 
of the state in which the patient is located and annotate the date and 
time that such a review was conducted in the patient's EHR. If the PDMP 
is unavailable or inaccessible for any reason, the prescribing 
practitioner must annotate the date and time that such a review was 
attempted in the patient's EHR and provide a reason as to why a review 
was unable to be completed.
    DEA and HHS estimate the following number of respondents and burden 
associated with this collection of information:
     Number of respondents: 37,425.
     Frequency of response: 1.804996.
     Number of responses: 67,552.
     Burden per response: 1 minute (0.01666667 hours).
     Total annual hour burden: 1,126 Hours.
    If you need a copy of the information collection instrument(s) with

[[Page 6522]]

instructions or additional information, please contact the Regulatory 
Drafting and Policy Support Section (DPW), Diversion Control Division, 
Drug Enforcement Administration; Mailing Address: 8701 Morrissette 
Drive, Springfield, Virginia 22152; Telephone: (571) 362-3261.
    Any additional comments on this collection of information may be 
sent in writing to the Office of Information and Regulatory Affairs, 
OMB, Attention: Desk Officer for DOJ, Washington, DC 20503. Please 
state that your comment refers to OMB Control Number 1117-NEW.

List of Subjects

21 CFR Part 1306

    Administrative practice and procedure, Drug traffic control, 
Prescription drugs, Reporting and recordkeeping requirements.

42 CFR Part 12

    Administrative practice and procedure.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
January 13, 2025, 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 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.
Miriam E. Delphin-Rittmon,
Assistant Secretary for Mental Health and Substance Use, Department of 
Health and Human Services.

DRUG ENFORCEMENT ADMINISTRATION

    For the reasons set out above, the Drug Enforcement Administration 
amends 21 CFR part 1306 as follows:

PART 1306--PRESCRIPTIONS

0
1. The authority citation for part 1306 continues to read as follows:

    Authority:  21 U.S.C. 821, 823, 829, 829a, 831, 871(b) unless 
otherwise noted.


Sec. Sec.  1306.28 through 1306.49  [Added and Reserved]

0
2. Add reserved Sec. Sec.  1306.28 through 1306.49.

0
3. Add an undesigned center heading and Sec.  1306.51 to read as 
follows:

Special Circumstances for Telemedicine Prescribing


Sec.  1306.51  Telemedicine prescribing of schedule III-V medications 
for the treatment of Opioid Use Disorder.

    (a) For purposes of this section, terms defined in part 1300 of 
this chapter, elsewhere in this chapter, or in 21 U.S.C. 802 and 829 
shall have the definitions set forth therein.
    (b) A practitioner may issue a prescription for schedule III-V 
controlled substances listed in 42 CFR 8.12(h)(2) as approved by the 
Food and Drug Administration (FDA) for use in the treatment of Opioid 
Use Disorder (OUD), defined as the use of an effective medication such 
as buprenorphine to treat OUD, pursuant to a communication between the 
prescribing practitioner and the patient using an interactive 
telecommunications system, including an audio-only telecommunications 
system, as described in 42 CFR 410.78(a)(3), if the following 
conditions are met:
    (1) Prescription drug monitoring program review. The prescribing 
practitioner must be authorized to access the applicable prescription 
drug monitoring program (PDMP) data of the state in which the patient 
is located at the time of the telemedicine encounter. The prescribing 
practitioner shall review such data regarding any controlled substance 
prescriptions issued to the patient in the last year, or, if less than 
one year of data is available, in the entire available period. The 
prescribing practitioner shall ensure the date and time of such a 
review is annotated in the patient's electronic health record (EHR) or 
paper record. This review, or attempted review, must be conducted prior 
to issuing a prescription in a manner authorized under this section.
    (2) Time limit. The practitioner may issue prescriptions to the 
patient pursuant to this section for a period not to exceed six 
calendar months beginning on the date the first prescription is issued. 
The practitioner may issue additional prescriptions to the patient for 
schedule III-V controlled substances approved by the FDA for use in the 
treatment of OUD either:
    (i) After the prescribing practitioner has conducted at least one 
in-person medical evaluation of the patient, as defined in 21 U.S.C. 
829(e)(2)(B); or
    (ii) As otherwise authorized by 21 U.S.C. 829(e), including 
pursuant to any other form of telemedicine as defined in 21 U.S.C. 
802(54) or pursuant to practices as determined by regulation issued 
pursuant to 21 U.S.C. 829(e)(3)(B).
    (3) PDMP inaccessible or unavailable. If the PDMP data is 
inaccessible or unavailable for any reason, the prescribing 
practitioner shall annotate in the patient's EHR or paper record the 
date and time that an attempt to view the PDMP data was made and the 
reason the data could not be reviewed. A practitioner may prescribe a 
seven-day supply of medication and must perform another PDMP review 
before prescribing another seven-day supply. Each time the PDMP is 
reviewed or attempted to be reviewed, the date and time must be 
annotated in the patient's EHR. A seven-day supply prescribed pursuant 
to this paragraph (b)(3) counts toward the time limit described in 
paragraph (b)(2) of this section.
    (4) Pharmacy identification requirement. The pharmacist shall 
verify the identity of the patient prior to filling a controlled 
substance prescription issued under the authority of this section. The 
pharmacist shall verify the identity of the patient with a state or 
Federal Government-issued photographic identification card or other 
form of identification. For the purposes of verifying the identity of 
the patient, the pharmacist may accept identification in the manner 
described herein from any qualifying ``ultimate user'' as defined in 21 
U.S.C. 802(27) prior to filling the prescription.
    (5) Prescription only for treatment of OUD. Controlled substance 
prescriptions issued pursuant to this section may only be issued for 
the treatment of OUD, and subject to the requirements of this section.
    (6) Authorization to prescribe. The practitioner must be:
    (i) Authorized under Sec. Sec.  1301.11, 1301.12(a), and 
1301.13(e)(1)(iv) of this chapter to prescribe the basic class of 
controlled substance specified on the prescription; or
    (ii) Exempt from obtaining a registration to dispense controlled 
substances under 21 U.S.C. 822(d).
    (7) Consistent with general prescription requirements. The issuance 
of the controlled substance prescription otherwise complies with the 
requirements set forth in this part.

Department of Health and Human Services

    For the reasons set out above, the Department of Health and Human

[[Page 6523]]

Services amends 42 CFR part 12 as follows:

PART 12--TELEMEDICINE FLEXIBILITIES

0
4. The authority citation for part 12 continues to read as follows:

    Authority:  21 U.S.C. 802(54)(G).


0
5. Add subpart B to read as follows:

Subpart B--Telemedicine Prescribing


Sec.  12.3  Telemedicine prescribing of schedule III-V medications for 
the treatment of Opioid Use Disorder.

    (a) For purposes of this section, terms defined in 21 CFR part 
1300, elsewhere in 21 CFR chapter II, or in 21 U.S.C. 802 and 829 shall 
have the definitions set forth therein.
    (b) A practitioner may issue a prescription for schedule III-V 
controlled substances listed in 42 CFR 8.12(h)(2) as approved by the 
Food and Drug Administration (FDA) for use in the treatment of Opioid 
Use Disorder (OUD), defined as the use of an effective medication such 
as buprenorphine to treat OUD, pursuant to a communication between the 
prescribing practitioner and the patient using an interactive 
telecommunications system, including an audio-only telecommunications 
system, as described in 42 CFR 410.78(a)(3), if the following 
conditions are met:
    (1) Prescription drug monitoring program review. The prescribing 
practitioner must be authorized to access the applicable prescription 
drug monitoring program (PDMP) data of the state in which the patient 
is located at the time of the telemedicine encounter. The prescribing 
practitioner shall review such data regarding any controlled medication 
prescriptions issued to the patient in the last year, or, if less than 
one year of data is available, in the entire available period. The 
prescribing practitioner shall ensure the date and time of such a 
review is annotated in the patient's electronic health record (EHR) or 
paper record. This review, or attempted review, must be conducted prior 
to issuing a prescription in a manner authorized under this section.
    (2) Time limit. The practitioner may issue prescriptions to the 
patient pursuant to this section for a period not to exceed six 
calendar months beginning on the date the first prescription is issued. 
The practitioner may issue additional prescriptions to the patient for 
schedule III-V controlled substances approved by the FDA for use in the 
treatment of OUD either:
    (i) As authorized by 21 U.S.C. 829(e), including pursuant to any 
other form of telemedicine as defined in 21 U.S.C. 802(54) or pursuant 
to practices as determined by regulation issued pursuant to 21 U.S.C. 
829(e)(3)(B); or
    (ii) After the prescribing practitioner has conducted at least one 
in-person medical evaluation of the patient, as defined in 21 U.S.C. 
829(e)(2)(B).
    (3) PDMP inaccessible or unavailable. If the PDMP data is 
inaccessible or unavailable for any reason, the prescribing 
practitioner shall annotate in the patient's EHR or paper record the 
date and time that an attempt to view the PDMP data was made and the 
reason the data could not be reviewed. A practitioner may prescribe a 
seven-day supply of medication and must perform another PDMP review 
before prescribing another seven-day supply. Each time the PDMP is 
reviewed or attempted to be reviewed, the date and time must be 
annotated in the patient's EHR. A seven-day supply prescribed pursuant 
to this paragraph (b)(3) counts toward the time limit described in 
paragraph (b)(2) of this section.
    (4) Pharmacy identification requirement. The pharmacist shall 
verify the identity of the patient prior to filling a controlled 
medication prescription issued under the authority of this section. The 
pharmacist shall verify the identity of the patient with a state or 
Federal Government-issued photographic identification card or other 
form of identification. For the purposes of verifying the identity of 
the patient, the pharmacist may accept identification in the manner 
described herein from any qualifying ``ultimate user'' as defined in 21 
U.S.C. 802(27) prior to filling the prescription.
    (5) Prescription only for treatment of OUD. Controlled medication 
prescriptions issued pursuant to this section may only be issued for 
the treatment of OUD.
    (6) Authorization to prescribe. The practitioner must be:
    (i) Authorized under 21 CFR 1301.13(e)(1)(iv) to prescribe the 
basic class of controlled medication specified on the prescription; or
    (ii) Exempt from obtaining a registration to dispense controlled 
substances under 21 U.S.C. 822(d).
    (7) Consistent with general prescription requirements. The issuance 
of the controlled substance prescription otherwise complies with the 
requirements set forth in 21 CFR part 1306.

[FR Doc. 2025-01049 Filed 1-15-25; 8:45 am]
BILLING CODE 4410-09-P`