Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, 30037-30043 [2023-09936]
Download as PDF
<![CDATA[
Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Rules and Regulations
DEPARTMENT OF JUSTICE
I. Background
Drug Enforcement Administration
Overview
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
Drug Enforcement
Administration, Department of Justice;
Substance Abuse and Mental Health
Services Administration, Department of
Health and Human Services.
ACTION: Temporary rule.
AGENCY:
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 inperson 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:
lotter on DSK11XQN23PROD with RULES1
SUMMARY:
VerDate Sep<11>2014
16:04 May 09, 2023
Jkt 259001
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 inperson 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
• 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
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.
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%
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
30037
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.
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 practitionerpatient 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.
20SAMHSA%20buprenorphine%20telemedicine
%20%20(Final)%20+Esign.pdf.
3 88 FR 12,875 (Mar. 1, 2023).
4 88 FR 12,890 (Mar. 1, 2023).
E:\FR\FM\10MYR1.SGM
10MYR1
30038
Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Rules and Regulations
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.
lotter on DSK11XQN23PROD with RULES1
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.
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 in5 88
FR 12,879, 12888 (Mar. 1, 2023).
88 FR at 12,882.
7 See id.
6 See
VerDate Sep<11>2014
16:04 May 09, 2023
Jkt 259001
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
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
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.
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.
9 21 U.S.C. 802(54)(G).
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
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.
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
10 It is anticipated that the COVID–19 PHE will
expire on May 11, 2023.
E:\FR\FM\10MYR1.SGM
10MYR1
Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Rules and Regulations
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.
lotter on DSK11XQN23PROD with RULES1
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
VerDate Sep<11>2014
16:04 May 09, 2023
Jkt 259001
by a practitioner acting in the usual
course of professional practice.11
• 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, realtime 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 audiovideo telecommunications system, but
the patient is not capable of, or does not
consent to, the use of video
technology.12
• 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
• Fourth, the prescription must be
consistent with all other requirements of
21 CFR part 1306.14
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
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.
12 See 42 CFR 410.78(a)(3); McDermott Letter at
2 (citing 21 U.S.C. 802(54)(D)); Prevoznik Letter at
2.
13 See McDermott Letter at 1.
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.
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
30039
regulatory requirements and would be
consistent with certain other statutory
extensions of healthcare-related
flexibilities beyond the end of the
COVID–19 PHE.15
• 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 sixmonth 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 practitionerpatient 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
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 § 4113, Dec. 29, 2022, 136
Stat. 4459, 5898.
E:\FR\FM\10MYR1.SGM
10MYR1
30040
Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Rules and Regulations
lotter on DSK11XQN23PROD with RULES1
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 shortterm 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, patientcentered 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.
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
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.
VerDate Sep<11>2014
16:04 May 09, 2023
Jkt 259001
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
• 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
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 § 4113, Dec. 29, 2022, 136
Stat. 4459, 5898.
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
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
E:\FR\FM\10MYR1.SGM
10MYR1
Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Rules and Regulations
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
lotter on DSK11XQN23PROD with RULES1
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
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
18 5
19 5
U.S.C. 553(d).
U.S.C. 553(d)(1), (3).
VerDate Sep<11>2014
16:04 May 09, 2023
Jkt 259001
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
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
30041
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
E:\FR\FM\10MYR1.SGM
10MYR1
30042
Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Rules and Regulations
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.
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
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).
2. Add an undesignated center header
after § 1307.31, and add § 1307.41 to
read as follows:
■
Special Exceptions Related to
Telemedicine
lotter on DSK11XQN23PROD with RULES1
§ 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.
20 5
U.S.C. 804(2).
VerDate Sep<11>2014
16:04 May 09, 2023
Jkt 259001
(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 DEAregistered practitioner is authorized to
prescribe schedule II–V controlled
substances via telemedicine, as defined
in § 1300.04(i) of this chapter, to a
patient without having conducted an inperson 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 § 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:
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
(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
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
§ 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
E:\FR\FM\10MYR1.SGM
10MYR1
Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Rules and Regulations
(ii) Pursuant to paragraph (c) of this
section.
(c) During the period May 12, 2023
through November 11, 2023, a DEAregistered 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
§ 12.2
[Reserved]
lotter on DSK11XQN23PROD with RULES1
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
VerDate Sep<11>2014
16:04 May 09, 2023
Jkt 259001
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
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2021–0788; FRL–10880–01–
OCSPP]
Cyflufenamid; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes a
tolerance for residues of cyflufenamid in
or on sugar beet. Nippon Soda Co., Ltd.
requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
SUMMARY:
This regulation is effective May
10, 2023. Objections and requests for
hearings must be received on or before
July 10, 2023 and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2021–0788 is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room and the OPP
Docket is (202) 566–1744. For the latest
status information on EPA/DC services,
docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Charles Smith, Director, Registration
Division (7505T), Office of Pesticide
Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; main
ADDRESSES:
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
30043
telephone number: (202) 566–1030;
email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Office of the Federal Register’s eCFR site at https://www.ecfr.gov/
current/title-40.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2021–0788 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing and must be received
by the Hearing Clerk on or before July
10, 2023. Addresses for mail and hand
delivery of objections and hearing
requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2021–0788, by one of the following
methods:
E:\FR\FM\10MYR1.SGM
10MYR1
]]>Agencies
[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]]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\3\ 88 FR 12,875 (Mar. 1, 2023).
\4\ 88 FR 12,890 (Mar. 1, 2023).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\5\ 88 FR 12,879, 12888 (Mar. 1, 2023).
\6\ See 88 FR at 12,882.
\7\ See id.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\9\ 21 U.S.C. 802(54)(G).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\10\ It is anticipated that the COVID-19 PHE will expire on May
11, 2023.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\12\ See 42 CFR 410.78(a)(3); McDermott Letter at 2 (citing 21
U.S.C. 802(54)(D)); Prevoznik Letter at 2.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\13\ See McDermott Letter at 1.
---------------------------------------------------------------------------
Fourth, the prescription must be consistent with all other
requirements of 21 CFR part 1306.\14\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\18\ 5 U.S.C. 553(d).
\19\ 5 U.S.C. 553(d)(1), (3).
---------------------------------------------------------------------------
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
