[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Rules and Regulations]
[Pages 30037-30043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09936]



[[Page 30037]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1307

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 12


Temporary Extension of COVID-19 Telemedicine Flexibilities for 
Prescription of Controlled Medications

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

ACTION: Temporary rule.

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SUMMARY: On March 1, 2023 the Drug Enforcement Administration (DEA), in 
concert with the Department of Health and Human Services (HHS), 
promulgated two notices of proposed rulemakings (NPRMs) soliciting 
comments on proposals to allow for prescribing of controlled 
medications pursuant to the practice of telemedicine in instances where 
the prescribing practitioner has never conducted an in-person medical 
evaluation of the patient. Those NPRMs resulted in 38,369 public 
comments, which are being closely reviewed. DEA, in concert with HHS, 
is considering revisions to the proposed rules set forth in the NPRMs. 
In the meantime, and following initial review of the comments received, 
DEA, jointly with the Substance Abuse and Mental Health Services 
Administration (SAMHSA), is issuing this temporary rule to extend 
certain exceptions granted to existing DEA regulations in March 2020 as 
a result of the COVID-19 Public Health Emergency (COVID-19 PHE), in 
order to avoid lapses in care for patients. Ultimately, there will be a 
final set of regulations permitting the practice of telemedicine under 
circumstances that are consistent with public health, safety, and 
effective controls against diversion.

DATES: This rule is effective May 11, 2023, through November 11, 2024.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, VA 22152, Telephone: (571) 776-3882.

SUPPLEMENTARY INFORMATION: 

I. Background

Overview

    Under the Ryan Haight Online Pharmacy Consumer Protection Act of 
2008 (the Ryan Haight Act), a prescribing practitioner--subject to 
certain exceptions--may prescribe controlled medications to a patient 
only after conducting an in-person evaluation of that patient. In 
response to the COVID-19 Public Health Emergency (COVID-19 PHE) as 
declared by the Secretary (the Secretary) of the Department of Health 
and Human Services (HHS) on January 31, 2020, pursuant to the authority 
under section 319 of the Public Health Service Act (42 U.S.C. 247), the 
Drug Enforcement Administration (DEA) granted temporary exceptions to 
the Ryan Haight Act and DEA's implementing regulations under 21 U.S.C. 
802(54)(D), thereby allowing the prescribing of controlled medications 
via telemedicine encounters--even when the prescribing practitioner had 
not conducted an in-person medical evaluation of the patient--in order 
to prevent lapses in care. These telemedicine flexibilities authorize 
practitioners to prescribe schedule II-V controlled medications via 
audio-video telemedicine encounters, including schedule III-V narcotic 
controlled medications approved by the Food and Drug Administration 
(FDA) for maintenance and withdrawal management treatment of opioid use 
disorder via audio-only telemedicine encounters, without requiring an 
in-person medical evaluation, provided that such prescriptions 
otherwise comply with the requirements outlined in DEA guidance 
documents, DEA regulations, and applicable Federal and State law. DEA 
granted those temporary exceptions to the Ryan Haight Act and DEA's 
implementing regulations via two letters published in March 2020:
     A March 25, 2020 ``Dear Registrant'' letter signed by 
William T. McDermott, DEA's then-Assistant Administrator, Diversion 
Control Division (the McDermott Letter); \1\ and
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    \1\ William T. McDermott, DEA Dear Registrant letter, Drug 
Enforcement Administration (March 25, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf.
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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).\2\
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    \2\ Thomas W. Prevoznik, DEA Dear Registrant letter, Drug 
Enforcement Administration (March 31, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Fina
l)%20+Esign.pdf.
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    On March 1, 2023, DEA, in concert with HHS, promulgated two NPRMs 
in the Federal Register--``Telemedicine prescribing of controlled 
substances when the practitioner and the patient have not had a prior 
in-person medical evaluation'' \3\ (the General Telemedicine Rule) and 
``Expansion of induction of buprenorphine via telemedicine encounter'' 
\4\ (the Buprenorphine Rule)--which proposed to expand patient access 
to prescriptions for controlled medications via telemedicine encounters 
relative to the pre-COVID-19 PHE landscape. The purpose of the two 
proposed rules was to make permanent some of the telemedicine 
flexibilities established during the COVID-19 PHE in order to 
facilitate patient access to controlled medications via telemedicine 
when consistent with public health and safety, while maintaining 
effective controls against diversion. The comment period for these two 
NPRMs closed on March 31, 2023. Those NPRMs generated a total of 38,369 
public comments--35,454 comments on the General Telemedicine Rule and 
2,915 comments on the Buprenorphine Rule.
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    \3\ 88 FR 12,875 (Mar. 1, 2023).
    \4\ 88 FR 12,890 (Mar. 1, 2023).
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    SAMHSA and DEA strongly support policies that promote access to 
effective and safe treatment for opioid use disorder, including through 
telemedicine platforms, and ensuring continued access to necessary 
controlled medications past the COVID-PHE.
    After reviewing those comments, DEA, jointly with SAMHSA, is 
issuing this temporary rule to effectuate the following:
     The full set of telemedicine flexibilities regarding 
prescription of controlled medications as were in place during the 
COVID-19 PHE will remain in place through November 11, 2023.
     Additionally, for any practitioner-patient telemedicine 
relationships that have been or will be established on or before 
November 11, 2023, the full set of telemedicine flexibilities regarding 
prescription of controlled medications as were in place during the 
COVID-19 PHE will continue to be permitted via a one-year grace period 
through November 11, 2024. In other words, if a patient and a 
practitioner have established a telemedicine relationship on or before 
November 11, 2023, the same telemedicine flexibilities that have 
governed the relationship to that point are permitted until November 
11, 2024.

[[Page 30038]]

    In the meantime, DEA is continuing to carefully evaluate the 
comments received on the NPRMs and anticipates implementation of a 
final set of regulations permitting the practice of telemedicine under 
circumstances that are consistent with public health, safety, and 
effective controls against diversion; the goal of this temporary rule 
is to ensure a smooth transition for patients and practitioners that 
have come to rely on the availability of telemedicine for controlled 
medication prescriptions, as well as allowing adequate time for 
providers to come into compliance with any new standards or safeguards 
that DEA and/or SAMHSA promulgate in one or more final rules.

History of This Rulemaking

    In the General Telemedicine Rule NPRM, DEA, in concert with HHS, 
proposed to extend the COVID-19 PHE telemedicine flexibilities for 180 
days beyond the end of the COVID-19 PHE for practitioner-patient 
relationships established via telemedicine encounters during the COVID-
19 PHE.\5\ Within the ``Request for Comments'' section, DEA requested 
comments concerning whether any additional regulatory provisions were 
warranted to ensure appropriate access to care, and noted that the 
proposed rule was designed to ensure that patients do not experience 
lapses in care.\6\ The ``Request for Comments'' section also explained 
that the proposed rule was designed to ensure continuity of care under 
the current telehealth flexibilities in place as a result of the COVID-
19 PHE.\7\ In response to the proposed rule and these requests for 
comments, DEA received hundreds of comments in support of further 
extending, beyond the initial period of 180 days, the telemedicine 
flexibilities for registrants who established practitioner-patient 
relationships via telemedicine encounters during the COVID-19 PHE. DEA 
also received thousands of comments supporting a similar extension of 
the COVID-19 PHE telemedicine flexibilities, for at least 180 days, for 
practitioner-patient relationships that will begin after the end of the 
COVID-19 PHE.
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    \5\ 88 FR 12,879, 12888 (Mar. 1, 2023).
    \6\ See 88 FR at 12,882.
    \7\ See id.
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II. Legal Authority

    The Ryan Haight Act amended the Controlled Substances Act (CSA) to 
generally require that the dispensing of controlled medications by 
means of the internet be predicated on a valid prescription involving 
at least one in-person medical evaluation. At the same time, it also 
established excepted categories of telemedicine pursuant to which a 
practitioner may prescribe controlled medications for a patient despite 
never having evaluated that patient in person, provided that, among 
other things, such practice is in accordance with applicable Federal 
and State laws.\8\
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    \8\ 21 U.S.C. 802(54)(A)-(G). The Attorney General has delegated 
his rulemaking authority under this provision to the Administrator 
of DEA via 28 CFR 0.100. The Secretary of HHS delegated his 
rulemaking authority under 21 U.S.C. 802(54)(G) to the Assistant 
Secretary for Mental Health and Substance Use within the Substance 
Abuse and Mental Health Services Administration on May 4, 2023.
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    One of these categories authorizes the Attorney General and the 
Secretary of Health and Human Services to jointly promulgate rules that 
would allow practitioners to prescribe medications for patients via 
telemedicine without having had an in-person evaluation when such 
telemedicine practice is in accordance with applicable Federal and 
State laws, uses an approved telecommunications system, and is 
``conducted under . . . circumstances that the[y have] . . . determined 
to be consistent with effective controls against diversion and 
otherwise consistent with the public health and safety.'' \9\
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    \9\ 21 U.S.C. 802(54)(G).
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    Pursuant to this authority, and in response to comments received on 
the NPRMs, DEA, jointly with SAMHSA, is hereby promulgating a temporary 
rule specifying certain circumstances under which practitioners may 
prescribe controlled medications, for a narrow time period, to patients 
whom the practitioner has never evaluated in person. This temporary 
rule covers the portions of the NPRM related to extensions of the 
telemedicine flexibilities in place during the COVID-19 PHE, and it 
extends, through November 11, 2023, the telemedicine flexibilities that 
have been in place since March 2020 for prescribing controlled 
medications via the practice of telemedicine. This temporary rule also 
extends the COVID-19 PHE telemedicine flexibilities through November 
11, 2024, as applied to any practitioner-patient relationships 
established via telemedicine encounters on or before November 11, 2023. 
In other words, as long as a practitioner and patient have established 
a telemedicine relationship on or before November 11, 2023, the 
pandemic telemedicine flexibilities will be extended through November 
11, 2024, as to that established relationship. These telemedicine 
flexibilities will not be applicable to any practitioner-patient 
relationships established after November 11, 2023. As noted previously, 
DEA and/or SAMHSA anticipate implementing a final set of regulations 
permitting the practice of telemedicine under circumstances that are 
consistent with public health, safety, and effective controls against 
diversion. However, given the impending end of the COVID-19 PHE and in 
recognition of comments received,\10\ DEA, jointly with SAMHSA, has 
elected to extend those flexibilities to avoid lapses in care.
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    \10\ It is anticipated that the COVID-19 PHE will expire on May 
11, 2023.
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    As explained further below, because this is a temporary extension 
of flexibilities that existed during the COVID-19 PHE, DEA and SAMHSA 
have determined that this temporary rule is consistent ``with effective 
controls against diversion and otherwise consistent with the public 
health and safety'' as required under 21 U.S.C. 802(54)(G). DEA, 
jointly with SAMHSA, is promulgating this temporary rule pursuant to 21 
U.S.C. 802(54)(G).
    DEA is issuing these regulatory changes jointly with SAMHSA. SAMHSA 
concurs with this rule. SAMHSA also has advised DEA that no additional 
rulemaking by SAMHSA is necessary as it pertains to the promulgation of 
these provisions pursuant to 21 U.S.C. 802(54)(G).

III. Purpose and Need for Regulatory Changes

    The purpose of this rulemaking is to extend for a limited period of 
time the telemedicine flexibilities that existed during the COVID-19 
PHE in order to:
     Facilitate continuity of care for telemedicine 
relationships established via telemedicine during the COVID-19 PHE;
     For relationships established both during the COVID-19 PHE 
and those established shortly after, prevent backlogs with respect to 
in-person medical evaluations in the months shortly before and after 
the expiration of the COVID-19 PHE and ensure the availability of 
telemedicine for practitioners and patients that have come to rely on 
it;
     Address the urgent public health need for continued access 
to the initiation of buprenorphine as medication for opioid use 
disorder in the context of the continuing opioid public health crisis;
     Allow patients, practitioners, pharmacists, service 
providers, and other stakeholders sufficient time to

[[Page 30039]]

prepare for the implementation of any future regulations that apply to 
prescribing of controlled medications via telemedicine;
     Enable DEA, jointly with SAMHSA, to thoroughly review and 
respond to the 38,369 comments they received in response to the two 
NPRMs; and
     Enable DEA, jointly with SAMHSA, to conduct a thorough 
evaluation of regulatory alternatives in order to promulgate 
regulations that most effectively expand access to telemedicine 
encounters in a manner that is consistent with public health and 
safety, while maintaining effective controls against diversion.

IV. Summary of Temporary Rule Changes

    This rule adds new 21 CFR 1307.41 and 42 CFR 12.1, effective from 
the day after the public health emergency ends, which is expected to be 
May 12, 2023, through November 11, 2024. Paragraph (a) states that this 
temporary rule is in effect until November 11, 2024, and will expire at 
the end of that day. It also states that the authorization granted in 
paragraph (c) expires at the end of November 11, 2023.
    Paragraph (b) states that a practitioner and patient have a 
``telemedicine relationship established via COVID-19 telemedicine 
prescribing flexibilities'' if the practitioner issued the patient a 
prescription for controlled medications pursuant to the telemedicine 
flexibilities that were available during the COVID-19 PHE and extended 
through November 11, 2023 by this temporary rule.
    Paragraph (c) extends the COVID-19 telemedicine prescribing 
flexibilities for six months, from May 12, 2023 through November 11, 
2023, provided all of the conditions listed in paragraph (e) are met.
    Paragraph (d) provides for a partial extension of those telehealth 
flexibilities through November 11, 2024, but only with respect to 
patients with whom the prescribing practitioner has a telemedicine 
relationship established via COVID-19 telemedicine prescribing 
flexibilities on or before November 11, 2023, as defined in paragraph 
(b) and provided all the conditions listed in paragraph (e) are met.
    Paragraph (e) describes the conditions which must be met for 
practitioners to issue prescriptions pursuant to paragraphs (c) and 
(d). All such requirements were in place during the COVID-19 PHE:
     First, the prescription must be issued for a legitimate 
medical purpose by a practitioner acting in the usual course of 
professional practice.\11\
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    \11\ See 21 CFR 1306.04(a); Prevoznik letter at 2. Though not 
specifically mentioned in the McDermott letter, the McDermott letter 
did not provide an exemption to the requirement in 21 CFR 1306.04(a) 
that every prescription must be issued for a legitimate medical 
purpose by a practitioner acting in the usual course of professional 
practice.
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     Second, the prescription must be issued pursuant to a 
communication between a practitioner and a patient using an interactive 
telecommunications system referred to in 42 CFR 410.78(a)(3)--that is, 
audio and video equipment permitting two-way, real-time interactive 
communication or, for prescriptions to treat a mental health disorder--
which include, but are not limited to, prescriptions for buprenorphine 
for opioid use disorder--a two-way, real-time audio-only communication 
if the distant site physician or practitioner is technically capable of 
using an interactive audio-video telecommunications system, but the 
patient is not capable of, or does not consent to, the use of video 
technology.\12\
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    \12\ See 42 CFR 410.78(a)(3); McDermott Letter at 2 (citing 21 
U.S.C. 802(54)(D)); Prevoznik Letter at 2.
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     Third, the practitioner must be authorized under their 
registration under 21 CFR 1301.13(e)(1)(iv) to prescribe the basic 
class of controlled medications specified on the prescription or exempt 
from obtaining a registration to dispense controlled medications under 
21 U.S.C. 822(d).\13\
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    \13\ See McDermott Letter at 1.
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     Fourth, the prescription must be consistent with all other 
requirements of 21 CFR part 1306.\14\
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    \14\ Both the McDermott Letter and the Prevoznik Letter 
specified which requirements of Part 1306 from which practitioners 
were exempted. Requirements not exempted in the letters remained in 
effect.
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V. Discussion of Comments

    Comment: DEA received several thousand comments supporting an 
extension of the COVID-19 PHE telemedicine flexibilities for all 
practitioner-patient telemedicine relationships, not only those 
established during the COVID-19 PHE. Commenters raised the following 
arguments in support of extending the COVID-19 telehealth flexibilities 
for all practitioner-patient telemedicine relationships:
     If DEA, jointly with SAMHSA, were to extend the 
telemedicine flexibilities to the dates suggested by commenters, such 
as until December 31, 2024, it would provide DEA, SAMHSA, and other 
agencies with a longer timeframe to educate patients, practitioners, 
and pharmacies about any changes in regulatory requirements and would 
be consistent with certain other statutory extensions of healthcare-
related flexibilities beyond the end of the COVID-19 PHE.\15\
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    \15\ Some commenters noted that Section 4113 of the Health 
Extenders, Improving Access to Medicare, Medicaid, and CHIP, and 
Strengthening Public Health Act of 2022 (Division FF of the 
Consolidated Appropriations Act, 2023) has extended some 
flexibilities to Medicare beneficiaries through December 31, 2024 
and asked for a similar extension with respect to telemedicine 
prescribing flexibilities for controlled medications. See 
Consolidated Appropriations Act, 2023, Public Law 117-328, Div. FF 
Sec.  4113, Dec. 29, 2022, 136 Stat. 4459, 5898.
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     In the absence of an extension, practitioners could be 
inundated with in-person evaluation requests and backlogs for in-person 
medical evaluations might result. Along similar lines, practitioner 
infrastructure might prove inadequate if practitioners were inundated 
with in-person evaluation requests over a short period of time.
    DEA also received several comments generally opposing an extension 
of the telemedicine flexibilities. Commenters raised the following 
arguments in support of this position:
     The telemedicine flexibilities that existed during the 
COVID-19 PHE increased diversion and overprescribing of some controlled 
medications, particularly as a result of certain telemedicine companies 
that do not conduct or require bona fide medical evaluations of 
patients prior to issuance of controlled medication prescriptions.
    Response: DEA and SAMHSA largely agree with the arguments asserted 
in the comments on this issue for broadening the extension to all 
practitioner-patient relationships for an additional six-month period, 
not only for those relationships established during the COVID-19 PHE. 
Accordingly, at this time, DEA, jointly with SAMHSA, has elected to 
extend the telemedicine flexibilities not only for practitioner-patient 
relationships established via telemedicine encounters during the COVID-
19 PHE, but also for those relationships established via telemedicine 
encounters after the end of the COVID-19 PHE, for a period of six 
months, through November 11, 2023. It is planned that one or more final 
rules will be issued based on the two proposed rules published on March 
1, 2023.
    DEA and SAMHSA agree that immediately ceasing the COVID-19 
telemedicine flexibilities for relationships established both during 
and following the end of the COVID-19 PHE would jeopardize continuity 
of patient care. In particular, without a general extension, patients 
seeking

[[Page 30040]]

prescriptions of controlled medications following expiration of the 
COVID-19 PHE as a result of existing or new practitioner-patient 
telemedicine relationships might be met with backlogs, as practitioners 
might be inundated with requests for in-person medical evaluations. In 
addition, practitioners might find it difficult to manage the period 
shortly after the COVID-19 PHE expires with respect to new patients in 
the absence of a short-term extension of the flexibilities that have 
existed since March 2020.
    DEA and SAMHSA anticipate the issuance of final rules extending 
certain telemedicine flexibilities on a permanent basis. At this time, 
DEA does not believe it would be consistent with effective controls 
against diversion to grant a longer extension--beyond this initial six-
month period--for practitioner-patient relationships that begin after 
the end of the COVID-19 PHE. This is an effort to disincentivize the 
creation of telemedicine companies that may seek to engage in 
problematic prescribing practices. By only extending the flexibilities 
for a short period, the six-month extension would be unlikely to 
incentivize the investment necessary to develop new telemedicine 
companies that might encourage or enable problematic prescribing 
practices. DEA stresses that, while certain telemedicine companies may 
engage in problematic behavior, many telemedicine companies are engaged 
in good faith, patient-centered prescribing practices. DEA looks 
forward to working with them--and future companies in this space--to 
further enhance patient access to needed medications when telemedicine 
prescriptions are appropriate and issued in the usual course of 
professional practice following bona fide medical evaluations.\16\ In 
the meantime, DEA is actively investigating certain telemedicine 
companies that it believes may have engaged in problematic prescribing 
practices.
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    \16\ The Ryan Haight Act makes it unlawful for an entity to 
knowingly or intentionally cause the internet to be used to bring 
together a buyer and seller to engage in the dispensing of a 
controlled substance in a manner not authorized by law. See 21 
U.S.C. 841(h)(2)(C). In spite of this clear statutory prohibition, 
DEA is aware of certain rogue websites that were designed primarily 
to make money by selling prescription drugs containing controlled 
substances without bona fide medical evaluations for patients.
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    In addition, and as noted above, DEA received 38,369 comments on 
the General Telemedicine Rule and the Buprenorphine Rule. DEA is 
currently in the process of closely evaluating those comments, as well 
as all regulatory options available, but anticipates that this review 
will extend beyond the end of the COVID-19 PHE, which is expected to 
expire at the end of the day on May 11, 2023. Ultimately, DEA and 
SAMHSA anticipate implementing a final set of regulations permitting 
the practice of telemedicine under circumstances that are consistent 
with public health and safety, while maintaining effective controls 
against diversion. In the meantime, given the limited duration of this 
extension of the telemedicine flexibilities and legitimate concerns 
regarding patient access to care following the end of the COVID-19 PHE, 
DEA, jointly with SAMHSA, finds that the limited extension of the 
telemedicine flexibilities that existed during the COVID-19 PHE is 
consistent with public health, safety, and effective controls against 
diversion.
    Comment: DEA also received several hundred comments supporting a 
further grace period--beyond 180 days--for requiring an in-person 
evaluation for practitioner-patient telemedicine relationships 
established during the COVID-19 PHE. Commenters raised the following 
arguments in support of this position:
     If DEA, jointly with SAMHSA, were to extend the 
telemedicine flexibilities for a longer period, such as until December 
31, 2024, it would provide DEA, SAMHSA, and other agencies with a 
longer timeframe to educate patients and practitioners that have 
already established relationships and come to rely on the COVID-19 PHE 
flexibilities about any changes in regulatory requirements. Such a date 
would also be consistent with certain other statutory extensions of 
healthcare-related flexibilities beyond the end of the COVID-19 
PHE.\17\
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    \17\ Some commenters noted that Section 4113 of the Consolidated 
Appropriations Act of 2023 has extended some flexibilities to 
Medicare beneficiaries through December 31, 2024 and asked for a 
similar extension with respect to telemedicine prescribing 
flexibilities for controlled medications. See Consolidated 
Appropriations Act, 2023, Public Law 117-328, Div. FF Sec.  4113, 
Dec. 29, 2022, 136 Stat. 4459, 5898.
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     In the absence of a grace period, practitioners could be 
inundated with in-person evaluation requests and backlogs for in-person 
medical evaluations might result.
     It may prove difficult for patients to obtain in-person 
medical evaluations within 180 days with practitioners with whom they 
have established legitimate telemedicine relationships given 
constraints on such patients' ability to travel, including the distance 
between the patient and practitioner, the need to request time off from 
work, or difficulty obtaining childcare.
    DEA also received several comments generally opposing a grace 
period with respect to the telemedicine prescribing flexibilities. 
Commenters raised the following arguments in support of this position:
     The telemedicine flexibilities that existed during the 
COVID-19 PHE may have increased diversion and overprescribing of some 
controlled medications, particularly as a result of for-profit 
telemedicine companies that do not conduct or require bona fide medical 
evaluations of patients prior to issuance of controlled medication 
prescriptions.
    Response: DEA and SAMHSA largely agree with the arguments asserted 
in the comments on this issue for lengthening the grace period for 
relationships that began during the COVID-19 PHE or that will begin 
during the extension granted for the next six months. DEA and SAMHSA 
are concerned that a 180-day period would be too brief an exemption for 
practitioner-patient telemedicine relationships established during the 
COVID-19 pandemic, as both practitioners and patients may have come to 
rely on the ability to meet via telemedicine. In addition, with a grace 
period of only 180 days, practitioners--including those with 
significant numbers of telemedicine patients--might find it difficult 
to meet with all patients with whom they had developed a telehealth 
relationship during the COVID-19 PHE or in the six months after. 
Accordingly, for those practitioner-patient relationships established 
between the start of the COVID-19 PHE and November 11, 2023, DEA, 
jointly with SAMHSA, is permitting a grace period for the COVID-19 PHE 
telehealth flexibilities through November 11, 2024, as they have 
determined that doing so would be consistent with public health and 
safety as required under 21 U.S.C. 802(54)(G).
    With respect to the arguments against the grace period, DEA agrees 
with commenters who noted that there were instances of overprescribing 
and potentially diversion during the COVID-19 PHE, particularly with 
respect to certain for-profit telemedicine companies. However, DEA 
believes that authorizing an initial time-limited grace period for the 
telemedicine flexibilities as they have existed during the COVID-19 PHE 
for practitioner-patient telemedicine relationships established during 
the COVID-19 PHE and for the six months thereafter would be consistent 
with effective controls against diversion. DEA believes this limited 
extension through November 11, 2024, would be unlikely to incentivize 
the investment necessary to further develop telemedicine companies that 
have already encouraged and enabled

[[Page 30041]]

these problematic prescribing practices during the COVID-19 PHE. 
Accordingly, at this time, DEA, jointly with SAMHSA, finds that the 
one-year grace period granted herein with respect to relationships 
established between the start of the COVID-19 PHE and November 11, 
2023, is consistent with effective controls against diversion as 
required under 21 U.S.C. 802(54)(G).

VI. Regulatory Analyses

Administrative Procedure Act

    DEA has considered the public comments it received on the two 
proposed rules, regarding the continuation of the flexibilities that 
will be implemented by this temporary rule. An agency may find good 
cause to exempt a rule from certain provisions of the Administrative 
Procedure Act (APA). Under the APA, agencies must generally provide a 
30-day delayed effective date for final rules.\18\ An agency may 
dispense with the 30-day delayed effective date requirement ``for good 
cause found and published with the rule'' or for ``a substantive rule 
which grants or recognizes an exemption or relieves a restriction.'' 
\19\
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    \18\ 5 U.S.C. 553(d).
    \19\ 5 U.S.C. 553(d)(1), (3).
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    As discussed earlier, DEA, jointly with SAMHSA, is publishing this 
temporary rule to extend certain exceptions granted to existing DEA 
regulations in March 2020 as a result of the COVID-19 PHE in order to 
avoid lapses in care for patients. In particular, if this 30-day delay 
applied, patients might experience a lapse in care because the existing 
telemedicine flexibilities would end on May 11, 2023. For these 
reasons, DEA, jointly with SAMHSA, concludes that such good cause 
exists to justify an immediate effective date for this temporary rule.

Executive Orders 12866 (Regulatory Planning and Review), 13563 
(Improving Regulation and Regulatory Review).

    This temporary rule was developed in accordance with the principles 
of Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies 
to assess all costs and benefits of available regulatory alternatives 
and, if regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health, and safety effects; distributive impacts; and equity). 
E.O. 13563 is supplemental to and reaffirms the principles, structures, 
and definitions governing regulatory review established in E.O. 12866. 
E.O. 12866 classifies a ``significant regulatory action,'' requiring 
review by the Office of Management and Budget (OMB), as any regulatory 
action that is likely to result in a rule that may: (1) have an annual 
effect on the economy of $200 million or more (adjusted every 3 years 
by the Administrator of OIRA for changes in gross domestic product); or 
adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, territorial, or tribal governments 
or communities; (2) create a serious inconsistency or otherwise 
interfere with an action taken or planned by another agency; (3) 
materially alter the budgetary impact of entitlements, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) raise legal or policy issues for which centralized 
review would meaningfully further the President's priorities or the 
principles set forth in this E.O., as specifically authorized in a 
timely manner by the Administrator of OIRA in each case.
    The economic, interagency, budgetary, legal, and policy 
implications of this proposed rule have been examined, and DEA has 
determined that it is a significant regulatory action under E.O. 12866, 
but not a Section 3(f)(1) significant regulatory action. Accordingly, 
this rule has been submitted to the OMB for review.
    DEA, jointly with SAMHSA, is publishing this temporary rule to 
extend certain exceptions DEA granted to its existing regulations in 
March 2020 as a result of the COVID-19 PHE in order to avoid lapses in 
coverage for patients. DEA and/or SAMHSA anticipate publishing at least 
one final rule as part of these rulemakings.
    Without this temporary rule, COVID-19 PHE telemedicine 
flexibilities are scheduled to expire on May 11, 2023. This rule 
extends the expiration of those flexibilities through November 11, 2023 
for all telemedicine relationships, and through November 11, 2024, for 
such telemedicine relationships that were established on or before 
November 11, 2023. Because this rule does not create or remove any 
regulatory requirements, DEA and SAMHSA estimate that there is no cost 
associated with this temporary rule. However, DEA and SAMHSA believe 
this extension and grace period create a benefit in form of cost 
savings to prescribers and patients and reduced transfer payments to 
the federal government, similar to those described in the General 
Telemedicine Rule.
    However, due to the nature of this rule, differing policies between 
the flexibilities being extended with this temporary rule and the 
flexibilities still proposed in the General Telemedicine Rule, and the 
expectation that additional policy will be addressed in a final rule 
prior to the expiration date of November 11, 2023, DEA is unable to 
quantify the cost savings and reduction in transfer payments.

Executive Order 12988, Civil Justice Reform

    The temporary rule meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to 
eliminate ambiguity, minimize litigation, establish clear legal 
standards, and reduce burden.

Executive Order 13132, Federalism

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

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This temporary rule does not have substantial direct effects on the 
Tribes, on the relationship between the national government and the 
Tribes, or the distribution of power and responsibilities between the 
Federal Government and Indian Tribes.

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act (5 U.S.C. 601-612) (RFA), has reviewed this Temporary Rule and by 
approving it certifies that it will not have a significant economic 
impact on a substantial number of small entities. This Temporary Rule, 
as discussed above, merely extends for a limited time the status quo 
with respect to the current flexibilities allowed during the COVID-19 
PHE, in order to avoid lapses in coverage for patients.
    Without this temporary rule, COVID-19 PHE telemedicine 
flexibilities would expire on May 11, 2023. While this temporary rule 
does not create or remove any regulatory requirements, this temporary 
rule extends the expiration of those flexibilities through November 11, 
2023 and provides a grace period for certain telemedicine relationships 
through November 11, 2024. DEA and SAMHSA believe this extension and 
grace period create a benefit in form of cost savings to

[[Page 30042]]

prescribers and patients and reduced transfer payments to the federal 
government. However, the benefits have a sunset provision; 
additionally, this rule is expected to be supplemented by another rule 
prior to the expiration date of November 11, 2023.
    In accordance with the RFA, DEA will be evaluating the impact on 
small entities at the time the final rule or rules are issued as part 
of these rulemakings.

Paperwork Reduction Act of 1995

    This temporary rule will not impose a new collection or modify an 
existing collection of information under the Paperwork Reduction Act of 
1995 (44 U.S.C. 3501-3521). Also, this temporary rule does not impose 
recordkeeping or reporting requirements on State or local governments, 
individuals, businesses, or other organizations. 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.

Congressional Review Act

    This temporary rule is not a major rule as defined by Subtitle E of 
the Small Business Regulatory Enforcement Fairness Act of 1996 (known 
as the Congressional Review Act or CRA).\20\ However, pursuant to the 
CRA, DEA is submitting a copy of this temporary rule to both Houses of 
Congress and to the Comptroller General.
---------------------------------------------------------------------------

    \20\ 5 U.S.C. 804(2).
---------------------------------------------------------------------------

List of Subjects in 21 CFR Part 1307

    Administrative practice and procedure, Drug traffic control, 
Prescription drugs.

    For the reasons set out above, the Drug Enforcement Administration 
is amending 21 CFR part 1307 as follows:

PART 1307--MISCELLANEOUS

0
1. The authority citation for part 1307 continues to read as follows:

    Authority:  21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).


0
2. Add an undesignated center header after Sec.  1307.31, and add Sec.  
1307.41 to read as follows:

Special Exceptions Related to Telemedicine


Sec.  1307.41   Temporary Extension of Certain COVID-19 Telemedicine 
Flexibilities for Prescription of Controlled Medications.

    (a) This section is in effect until the end of the day November 11, 
2024. The authorization granted in paragraph (c) of this section 
expires at the end of November 11, 2023.
    (b) For purposes of this section, a practitioner and a patient have 
a telemedicine relationship established via COVID-19 telemedicine 
prescribing flexibilities if:
    (1) The practitioner has not conducted an in-person medical 
evaluation of the patient; and
    (2) The practitioner has prescribed one or more controlled 
substances to the patient
    (i) Pursuant to the designation on March 16, 2020, by the Secretary 
of Health and Human Services, with concurrence of the Acting DEA 
Administrator, that the telemedicine allowance under 21 U.S.C. 
802(54)(D) applies to all schedule II-V controlled substances in all 
areas of the United States for the duration of the nationwide public 
health emergency declared by the Secretary of Health and Human Services 
on January 31, 2020, as a result of the Coronavirus Disease 2019 
pursuant to the authority under section 319 of the Public Health 
Service Act (42 U.S.C. 247); or
    (ii) Pursuant to paragraph (c) of this section.
    (c) During the period May 12, 2023 through November 11, 2023, a 
DEA-registered practitioner is authorized to prescribe schedule II-V 
controlled substances via telemedicine, as defined in Sec.  1300.04(i) 
of this chapter, to a patient without having conducted an in-person 
medical evaluation of the patient if all of the conditions listed in 
paragraph (e) of this section are met.
    (d) During the period November 12, 2023 through November 11, 2024, 
a DEA-registered practitioner is authorized to prescribe schedule II-V 
controlled substances via telemedicine, as defined in Sec.  1300.04(i) 
of this chapter, to a patient with whom the practitioner has a 
telemedicine relationship established via COVID-19 telemedicine 
prescribing flexibilities without having conducted an in-person medical 
evaluation of a patient if all of the conditions listed in paragraph 
(e) of this section are met.
    (e) A practitioner is only authorized to issue prescriptions for 
controlled substances pursuant to paragraphs (c) or (d) of this section 
if all of the following conditions are met:
    (1) The prescription is issued for a legitimate medical purpose by 
a practitioner acting in the usual course of professional practice;
    (2) The prescription is issued pursuant to a communication between 
a practitioner and a patient using an interactive telecommunications 
system referred to in 42 CFR 410.78(a)(3);
    (3) The practitioner is:
    (i) Authorized under their registration under 21 CFR 
1301.13(e)(1)(iv) 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); and
    (4) The prescription is consistent with all other requirements of 
21 CFR part 1306.

Title 42--Public Health

0
For the reasons set out above, the Department of Health and Human 
Services adds part 12 to title 42 of the Code of Federal Regulations to 
read as follows:

PART 12--TELEMEDICINE FLEXIBILITIES

Subpart A--Special Exceptions Related to Telemedicine
Sec.
12.1 Temporary Extension of Certain COVID-19 Telemedicine 
Flexibilities for Prescription of Controlled Medications.
12.2 [Reserved]

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

Subpart A--Special Exceptions Related to Telemedicine


Sec.  12.1  Temporary Extension of Certain COVID-19 Telemedicine 
Flexibilities for Prescription of Controlled Medications.

    (a) This section is in effect until the end of the day November 11, 
2024. The authorization granted in paragraph (c) of this section 
expires at the end of November 11, 2023.
    (b) For purposes of this section, a practitioner and a patient have 
a telemedicine relationship established via COVID-19 telemedicine 
prescribing flexibilities if:
    (1) The practitioner has not conducted an in-person medical 
evaluation of the patient; and
    (2) The practitioner has prescribed one or more controlled 
substances to the patient
    (i) Pursuant to the designation on March 16, 2020, by the Secretary 
of Health and Human Services, with concurrence of the Acting DEA 
Administrator, that the telemedicine allowance under 21 U.S.C. 
802(54)(D) applies to all schedule II-V controlled substances in all 
areas of the United States for the duration of the nationwide public 
health emergency declared by the Secretary of Health and Human Services 
on January 31, 2020, as a result of the Coronavirus Disease 2019 
pursuant to the authority under section 319 of the Public Health 
Service Act (42 U.S.C. 247); or

[[Page 30043]]

    (ii) Pursuant to paragraph (c) of this section.
    (c) During the period May 12, 2023 through November 11, 2023, a 
DEA-registered practitioner is authorized to prescribe schedule II-V 
controlled substances via telemedicine, as defined in 21 CFR 
1300.04(i), to a patient without having conducted an in-person medical 
evaluation of the patient if all of the conditions listed in paragraph 
(e) of this section are met.
    (d) During the period November 12, 2023 through November 11, 2024, 
a DEA-registered practitioner is authorized to prescribe schedule II-V 
controlled substances via telemedicine, as defined in 21 CFR 
1300.04(i), to a patient with whom the practitioner has a telemedicine 
relationship established via COVID-19 telemedicine prescribing 
flexibilities without having conducted an in-person medical evaluation 
of a patient if all of the conditions listed in paragraph (e) of this 
section are met.
    (e) A practitioner is only authorized to issue prescriptions for 
controlled substances pursuant to paragraphs (c) or (d) of this section 
if all of the following conditions are met:
    (1) The prescription is issued for a legitimate medical purpose by 
a practitioner acting in the usual course of professional practice;
    (2) The prescription is issued pursuant to a communication between 
a practitioner and a patient using an interactive telecommunications 
system referred to in 42 CFR 410.78(a)(3);
    (3) The practitioner is:
    (i) Authorized under their registration under 21 CFR 
1301.13(e)(1)(iv) 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); and
    (4) The prescription is consistent with all other requirements of 
21 CFR part 1306


Sec.  12.2   [Reserved]

Signing Authority

    This document of the Drug Enforcement Administration and the 
Department of Health and Human Services was signed on May 4, 2023, by 
Administrator Anne Milgram. Those documents with the original 
signatures and dates 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.

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
Miriam E. Delphin-Rittmon,
Assistant Secretary for Mental Health and Substance Use, Substance 
Abuse and Mental Health Services Administration.
[FR Doc. 2023-09936 Filed 5-9-23; 8:45 am]
BILLING CODE 4410-09-P; 4162-20-P