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