[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Proposed Rules]
[Pages 12875-12890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04248]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1304, and 1306
[Docket No. DEA-407]
RIN 1117-AB40
Telemedicine Prescribing of Controlled Substances When the
Practitioner and the Patient Have Not Had a Prior In-Person Medical
Evaluation
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: Under the Ryan Haight Online Pharmacy Consumer Protection Act
of 2008 and Drug Enforcement Administration's (DEA) implementing
regulations, after a patient and a practitioner have had an in-person
medical evaluation, that practitioner may use telehealth to prescribe
that patient any prescription for a controlled medication that the
practitioner deems medically necessary. The Ryan Haight Act and DEA's
implementing regulations do not apply to other forms of telemedicine,
telehealth, or telepsychiatry that are not otherwise addressed in the
Controlled Substances Act. This proposed rule applies only in limited
circumstances when the prescribing practitioner wishes to prescribe
controlled medications via the practice of telemedicine and has not
otherwise conducted an in-person medical evaluation prior to the
issuance of the prescription.
DATES: Electronic comments must be submitted, and written comments must
be postmarked, on or before March 31, 2023. Commenters should be aware
that the electronic Federal Docket Management System will not accept
comments after 11:59 p.m. Eastern Time on the last day of the comment
period.
All comments concerning collections of information under the
Paperwork Reduction Act must be submitted to the Office of Management
and Budget on or before March 31, 2023.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-407'' on all correspondence, including any
attachments.
Electronic Comments: The Drug Enforcement Administration encourages
that all comments be submitted through the Federal eRulemaking Portal,
which provides the ability to type short comments directly into the
comment field on the web page or to attach a file for lengthier
comments. Please go to http://www.regulations.gov/ and follow the
online instructions at that site for submitting comments. Upon
completion of your submission, you will receive a Comment Tracking
Number for your comment. Please be aware that submitted comments are
not instantaneously available for public view on Regulations.gov. If
you have received a Comment Tracking Number, your comment has been
successfully submitted and there is no need to resubmit the same
comment.
Paper Comments: Paper comments that duplicate an electronic
submission are not necessary and are discouraged. Should you wish to
mail a paper comment in lieu of an electronic comment, it should be
sent via regular or express mail to: Drug Enforcement Administration,
Attention: DEA Federal Register Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
Paperwork Reduction Act Comments: All comments concerning
collections of information under the Paperwork Reduction Act must be
submitted to the Office of Information and Regulatory Affairs, Office
of Management and Budget, Attention: Desk Officer for DOJ, Washington,
DC 20503. Please state that your comment refers to RIN 1117-AB40/Docket
No. DEA-407.
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:
Posting of Public Comments
Please note that all comments received, including attachments and
other supporting materials, are considered part of the public record.
They will be made available by the Drug Enforcement Administration
(``DEA'') for public inspection online at https://www.regulations.gov/.
The Freedom of Information Act applies to all comments received.
Confidential information or personal identifying information, such as
account numbers or Social Security numbers, or names of other
individuals, should not be included. Submissions will not be edited to
remove any identifying or contact information.
Comments with confidential information, which should not be made
available for public inspection, should be submitted as written/paper
submissions. Two written/paper copies should be submitted. One copy
will include the confidential information with a heading or cover sheet
that states ``CONTAINS CONFIDENTIAL INFORMATION.'' DEA will review this
copy, including the claimed confidential information, in its
consideration of comments. The second copy should have the claimed
confidential information redacted/blacked out. DEA will make this copy
available for public inspection online at https://www.regulations.gov/.
Other information, such as name and contact information, that should
not be made available, may be included on the cover sheet but not in
the body of the comment, and must be clearly identified as
``confidential.'' Any information clearly identified as
``confidential'' will not be disclosed except as required by law.
I. Executive Summary
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008
(``Ryan Haight Act'') \1\ amended the Controlled Substances Act
(``CSA'') in part by adding several new provisions to prevent the
illegal distribution and dispensing of controlled substances by means
of the internet. While the Ryan Haight Act amended the CSA to generally
require that the dispensing of controlled substances by means of the
internet be predicated on a valid prescription involving at least one
in-person medical evaluation, it also established seven distinct
categories \2\ 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.\3\ Notably, the Ryan Haight Act does not limit a practitioner's
ability to prescribe controlled medications for a patient after there
has been at least one in-person medical evaluation. This
[[Page 12876]]
rulemaking would authorize telemedicine pursuant to 21 U.S.C.
802(54)(G) in those instances where (1) the prescribing practitioner
has not conducted an in-person medical evaluation with the patient; (2)
the prescription was issued pursuant to a telemedicine encounter and
(3) the telemedicine encounter results in a prescription for controlled
medications. The regulatory requirements proposed in this rulemaking
would only apply to practitioners who issue prescriptions pursuant to
telemedicine encounters authorized under 802(54)(G). These regulatory
requirements would not apply to telemedicine practiced pursuant to (A)-
(F). Similarly, as described below, the Ryan Haight Act and DEA's
implementing regulations do not apply to other forms of telemedicine,
telehealth, or telepsychiatry that are not otherwise defined in the
CSA.
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\1\ Public Law 110-425 (2008). Because the Ryan Haight Act
amended the CSA, references in this document will generally be to
the CSA, except where additional specificity will improve clarity.
\2\ The seven categories are: (1) Treatment in a hospital or
clinic; (2) Treatment in the physical presence of a DEA-registered
practitioner; (3) Treatment by Indian Health Service or Tribal
practitioners; (4) Treatment during a public health emergency as
declared by the Secretary of Health and Human Services; (5)
Treatment by a practitioner who has obtained a ``special
registration''; (6) Treatment by Department of Veterans Affairs
practitioners during a medical emergency; and (7) Other
circumstances specified by regulation. 21 CFR 1300.04(i)(1)-(7).
\3\ 21 U.S.C. 802(54)(A)-(G).
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The Ryan Haight Act intended to address the threat to public health
and safety caused by physicians who prescribed controlled medications
via the internet without establishing a valid doctor-patient
relationship through such fundamental steps as performing an in-person
medical evaluation of a patient. Prior to the enactment of the Ryan
Haight Act, the internet was being exploited to facilitate the unlawful
distribution of controlled substances through rogue websites. These
rogue websites fueled the misuse of controlled prescription
medications, such as hydrocodone and oxycodone, thereby contributing to
increased drug poisonings and other harmful health, social, and
economic consequences.
The Ryan Haight Act was named for a California high school student
who died in 2001 from a drug poisoning resulting from a controlled
prescription medication he obtained from a rogue online pharmacy. That
rogue online pharmacy allowed customers, like Ryan and others, to
obtain controlled medications without an in-person medical evaluation
by the prescriber. In Ryan's case, and in many others, the ``[e]ase of
access to the internet, combined with lack of medical supervision, . .
. led to tragic consequences in the online purchase of prescriptions
for controlled substances.'' \4\
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\4\ S. Rep. No. 110-521, at 5 (2008).
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The Ryan Haight Act also authorizes the Administrator, in
conjunction with the Secretary of Health and Human Services
(``Secretary''), to promulgate rules that would allow practitioners to
treat patients via telemedicine without having had an in-person
evaluation in certain circumstances, including where such telemedicine
practice is in accordance with applicable Federal and State laws, uses
an approved telecommunications system, and is ``conducted under . . .
circumstances that the Attorney General and the Secretary have jointly,
by regulation, determined to be consistent with effective controls
against diversion and otherwise consistent with the public health and
safety.'' \5\ Pursuant to this authority, and in concert with the
Department of Health and Human Services (``HHS''), DEA and HHS are
hereby proposing to amend 21 CFR parts 1300, 1304, and 1306 to specify
the circumstances under which practitioners may prescribe controlled
medications, pursuant to 21 U.S.C. 802(54)(G), to patients whom the
practitioner has never evaluated in person, including that (1) such
prescriptions be in accordance with applicable Federal and State \6\
laws; and (2) such practitioners possess an active DEA dispensing
registration issued pursuant to 21 CFR 1301.13(e)(1)(iv) in the State
in which the practitioner is located (unless exempted).
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\5\ 21 U.S.C. 802(54)(G).
\6\ Under the CSA, ``State'' means ``a State of the United
States, the District of Columbia, and any commonwealth, territory,
or possession of the United States.'' 21 U.S.C. 802(26).
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DEA proposes to require practitioners to keep detailed records
regarding prescriptions issued as a result of a telemedicine encounter
at the registered location of their 21 CFR 1301.13(e)(1)(iv)
registration, in digital or paper form that is readily accessible.\7\
Under the proposed rule, a prescribing practitioner must include a
notation on the face of the prescription, or within the prescription
order if prescribed electronically, that the prescription has been
issued via a telemedicine encounter.\8\
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\7\ Proposed 21 CFR 1304.04(i).
\8\ Proposed 21 CFR 1306.05(i).
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The proposed rule allows for the prescription of non-narcotic \9\
schedule III-V controlled medications when certain circumstances are
met. For example, the proposed rule allows for the prescribing of
schedule III-V non-narcotic controlled medications when a practitioner,
prior to issuing a prescription, reviews recent prescription drug
monitoring program (``PDMP'') data, i.e., data made available by the
State in which the patient is located, regarding controlled medication
prescriptions issued to the patient in the last year or, if less than a
year of data is available, the entire available period.\10\
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\9\ Under the CSA, narcotic drugs are drugs that contain
opiates, cocaine, or ecgonine, as well as certain related plant
material. 21 U.S.C. 802(17). This definition includes buprenorphine,
a narcotic drug that has been approved by the FDA for maintenance
and detoxification treatment of opioid use disorder.
\10\ Proposed 21 CFR 1306.31(e)(1).
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Though excluded from the provisions of this proposed rule that
relate to the prescribing of non-narcotic schedule III-V controlled
medications, the prescribing of certain narcotic medications such as
buprenorphine via telemedicine for the treatment of opioid use disorder
is the subject of another notice of proposed rulemaking titled
``Expansion of induction of buprenorphine via telemedicine encounter''
(RIN 1117-AB78), published elsewhere in this issue of the Federal
Register, that would expand the circumstances under which the induction
of buprenorphine for ``maintenance treatment'' \11\ and
``detoxification treatment'' \12\ of opioid use disorder via
telemedicine can occur.
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\11\ 21 U.S.C. 802(29).
\12\ 21 U.S.C. 802(30).
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Additionally, the proposed rule generally would subject a
practitioner practicing telemedicine to initially limit prescriptions
for a controlled medication issued to a patient to a 30-day supply. A
practitioner would be allowed to issue multiple prescriptions for the
same patient, but would only be allowed to prescribe an amount less
than or equal to a total quantity of a 30-day supply of the controlled
medication.\13\ Thereafter, to continue prescribing to that patient,
within 30 days, the prescribing practitioner would be required to
examine the patient in person. Alternatively, if the prescribing
practitioner receives a qualifying telemedicine referral for the
patient in the manner described herein, the practitioner may rely on
the referring practitioner's in-person medical evaluation in order to
prescribe the controlled substance via telemedicine.\14\
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\13\ Proposed 21 CFR 1306.31(c)(2).
\14\ Proposed 21 CFR 1300.04(k), 1306.31(d).
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II. Legal Authority and Background
DEA implements and enforces the CSA and the Controlled Substances
Import and Export Act, (21 U.S.C. 801-971), as amended. DEA publishes
the implementing regulations for these statutes in 21 CFR parts 1300 to
end. These regulations are designed to ensure a sufficient supply of
controlled substances for medical, scientific, and other legitimate
purposes, and to deter the diversion of controlled substances for
illicit purposes.
As mandated by the CSA, DEA establishes and maintains a closed
[[Page 12877]]
system of control for manufacturing, distribution, and dispensing of
controlled substances, and requires any person who manufactures,
distributes, dispenses, imports, exports, or conducts research or
chemical analysis with controlled substances to register with DEA,
unless they meet an exemption, pursuant to 21 U.S.C. 822. ``Dispense''
in the context of this rulemaking means to deliver a controlled
substance to an ultimate user, which includes the prescribing of a
controlled substance.\15\ The CSA further authorizes the Administrator
to promulgate regulations necessary and appropriate to execute the
functions of subchapter I (Control and Enforcement) and subchapter II
(Import and Export) of the CSA.\16\
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\15\ 21 U.S.C 802(10).
\16\ 21 U.S.C. 871(b), 958(f).
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The Ryan Haight Act amended the CSA by, among other things, adding
several new provisions to prevent the illegal distribution and
dispensing of controlled substances by means of the internet. The Ryan
Haight Act applies only in limited circumstances where the prescribing
practitioner wishes to prescribe controlled medications via the
practice of telemedicine and has not otherwise conducted an in-person
medical evaluation prior to the issuance of the prescription. As
described below, the Ryan Haight Act and DEA's implementing regulations
do not apply to other forms of telemedicine, telehealth, or
telepsychiatry that are not otherwise defined in the CSA.
As indicated above, in 21 U.S.C. 829(e), the Ryan Haight Act
generally requires an in-person medical evaluation prior to the
prescription of controlled substances. Section 829(e), however, also
provides an exception to this in-person medical evaluation requirement
where the practitioner is ``engaged in the practice of telemedicine''
\17\ within the meaning of the Ryan Haight Act (21 U.S.C. 802(54)). To
fall within this definition of the ``practice of telemedicine,'' the
practice first must be ``in accordance with applicable Federal and
State laws'' and use ``a telecommunications system referred to in [42
U.S.C. 1395m(m)].'' \18\ Title 42 U.S.C. 1395m(m) references, but does
not define, such telecommunications systems. The Centers for Medicare &
Medicaid Services (``CMS''), however, has promulgated regulations for
the Medicare program implementing those provisions, and those
regulations do define ``interactive telecommunications system.'' In
particular, 42 CFR 410.78(a)(3) states: ``Interactive
telecommunications system means, except as otherwise provided in this
paragraph, multimedia communications equipment that includes, at a
minimum, audio and video equipment permitting two-way, real-time
interactive communication between the patient and distant site
physician or practitioner. For services furnished for purposes of
diagnosis, evaluation, or treatment of a mental health disorder to a
patient in their home, interactive telecommunications may include two-
way, real-time audio-only communication technology if the distant site
physician or practitioner is technically capable to use an interactive
telecommunications system as defined in the previous sentence, but the
patient is not capable of, or does not consent to, the use of video
technology.'' \19\
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\17\ Id. 829(e)(3)(A).
\18\ Id. 802(54).
\19\ See infra for discussion of the use of audio-only
technology in telemedicine under this proposed rule.
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The CSA and DEA's regulations only define the ``practice of
telemedicine'' for the purpose of establishing obligations under the
CSA and DEA regulations. DEA is not attempting to define what
constitutes appropriate telemedicine in other contexts. Thus, the
proposed rule would not determine when medications that are not
controlled may be appropriately prescribed via telemedicine or the
nature of appropriate remote medical treatment more generally.
Moreover, as noted, this proposed rule would not create any additional
regulatory requirements for other categories of telemedicine authorized
by the CSA under 21 U.S.C. 802(54)(A)-(F). Rather, it would create
additional circumstances under which the use of telemedicine to
prescribe controlled substances is authorized by the CSA.
Again, in the foregoing and other circumstances encompassed by the
Ryan Haight Act's definition of the ``practice of telemedicine,'' the
Act contemplates that the practitioner will be permitted to prescribe
controlled substances by means of the internet despite not having
conducted an in-person medical evaluation when certain safeguards are
in place to ensure that the practitioner who is engaged in the practice
of telemedicine is able to conduct or participate in a bona fide
medical evaluation of the patient at the remote location, and is
otherwise prescribing for a legitimate medical purpose while acting in
the usual course of professional practice.
Accordingly, as set forth in 21 U.S.C. 802(54), the Ryan Haight
Act's definition of the ``practice of telemedicine'' includes seven
distinct categories of telemedicine that Congress determined were
appropriate to allow for the prescribing of controlled substances
despite the practitioner never having evaluated the patient in
person.\20\ For example, to fall under the first category of the
``practice of telemedicine,'' the patient must be physically located in
a DEA-registered hospital or clinic, and the remote prescribing
practitioner generally must be properly registered with DEA in the
State in which the patient is located.\21\ To fall under the second
category, the patient generally must be being treated by, and in the
physical presence of, a practitioner who is registered with DEA in the
State in which the patient is located.\22\
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\20\ The fifth such category contemplates the prescription of
controlled substances via telemedicine encounters conducted by
practitioners to whom the DEA Administrator has issued ``special
registration[s].'' See 21 U.S.C. 802(54)(E). In the SUPPORT for
Patients and Communities Act (SUPPORT Act), signed into law on
October 24, 2018, Congress required DEA to promulgate regulations
concerning such special registrations. See id. 831(h)(2). This
instance of rulemaking, which sets forth circumstances under which
telemedicine encounters may result in the prescription of controlled
substances without an in-person evaluation and also provides
safeguards for such prescriptions, is consistent with, and fulfills,
DEA's obligations under both the Ryan Haight Act and the SUPPORT
Act.
\21\ Id. 802(54)(A). If practitioners are exempted from
registration in all States under DEA regulations or are employees or
contractors of the VA and meet certain conditions, they do not have
to be registered.
\22\ Id. 802(54)(B). If practitioners are exempted from
registration in all States under DEA regulations or are employees or
contractors of the VA and meet certain conditions, they do not have
to be registered.
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The definition of the ``practice of telemedicine'' also includes as
one of its seven categories a practice ``being conducted under any
other circumstances that the Attorney General and the Secretary have
jointly, by regulation, determined to be consistent with effective
controls against diversion and otherwise consistent with the public
health and safety.'' \23\ Pursuant to this authority, DEA and HHS are
hereby proposing a rule specifying the circumstances under which
practitioners may prescribe controlled substances to patients whom the
practitioner has never evaluated in person. This rulemaking would not
impose any new requirements on practitioners authorized to practice
telemedicine under other statutory exceptions in 21 U.S.C. 802(54),
such as Indian Health Service (``IHS'') and Tribal practitioners, who
are authorized to engage in the practice of telemedicine under a
different statutory paragraph,
[[Page 12878]]
802(54)(C). The proposed changes to DEA's regulations herein are
consistent ``with effective controls against diversion and otherwise
consistent with the public health and safety'' pursuant to 21 U.S.C.
802(54)(G).
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\23\ Id. 802(54)(G).
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DEA is proposing these regulatory changes in concert with HHS, and
HHS was consulted in the creation of these regulatory provisions and
concurs with this proposed rulemaking. HHS also has advised DEA that no
additional rulemaking by HHS is necessary as it pertains to the
promulgations of these provisions pursuant to 21 U.S.C. 802(54)(G).
III. Section-by-Section Discussion of Proposed Rule
This proposed rule describes the circumstances under which,
pursuant to 21 U.S.C. 802(54)(G), a practitioner may prescribe
controlled substances to patients whom the practitioner has not
evaluated in person.
A. Part 1300: Definitions
In section 21 CFR 1300.04, DEA is proposing to add definitions for
the following terms: practice of telemedicine; qualifying telemedicine
referral; telemedicine encounter; telemedicine prescription; and
telemedicine relationship established during the COVID-19 public health
emergency. In addition, DEA proposes to amend its regulations to
clarify one aspect of the definition of the practice of telemedicine,
and to remove an expired paragraph that provided a temporary definition
of the practice of telemedicine.
DEA proposes to amend its regulatory definition of the term
``practice of telemedicine'' to better explain, but not alter, its
requirements. The current regulatory definition, 21 CFR 1300.04(i),
follows the Ryan Haight Act's statutory definition, 21 U.S.C. 802(54),
by requiring that the practice of telemedicine take place ``using a
telecommunications system referred to in section 1834(m) of the Social
Security Act (42 U.S.C. 1395m(m)).'' As noted above, 42 U.S.C. 1395m(m)
references, but does not define, such telecommunications systems. CMS,
however, has promulgated regulations for the Medicare program
implementing those provisions that define ``interactive
telecommunications system,'' 42 CFR 410.78(a)(3), and it is to this CMS
definition that the Ryan Haight Act and DEA regulatory definitions of
the ``practice of telemedicine'' ultimately refer.
The proposed rule would revise the DEA regulatory definition of
``practice of telemedicine'' \24\ in accordance with this CMS
regulation to require that telemedicine take place ``using an
interactive telecommunications system referred to in 42 CFR
410.78(a)(3).'' This would not be a substantive change to DEA's
regulations, but merely a clarification of the existing requirements--
updating the language in 21 CFR 1300.04 to save readers from having to
cross-reference 42 U.S.C. 1395m(m) (and then ascertain what CMS
regulations implement it) to determine the nature of the
telecommunications systems that can be used to engage in the practice
of telemedicine under DEA regulations.
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\24\ Proposed 21 CFR 1300.04(j).
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That said, CMS recently revised 42 CFR 410.78(a)(3),\25\ and some
explanation of revised Sec. 410.78(a)(3)--and its implications for
this proposed rule--may be useful. Previously, Sec. 410.78(a)(3) had
limited an ``interactive telecommunications system'' to ``multimedia
communications equipment that includes, at a minimum, audio and video
equipment permitting two-way, real-time interactive communication
between the patient and distant site physician or practitioner.''
Revised Sec. 410.78(a)(3) retains this requirement of both audio and
video real-time communication between the patient and the distant
practitioner in most circumstances: as the CMS rule revising Sec.
410.78(a)(3) stated, ``[T]wo-way, audio/video communications technology
is the appropriate, general standard for telehealth services . . . .''
\26\
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\25\ Medicare Program; CY 2022 Payment Policies Under the
Physician Fee Schedule and Other Changes to Part B Payment Policies;
Medicare Shared Savings Program Requirements; Provider Enrollment
Regulation Updates; and Provider and Supplier Prepayment and Post-
Payment Medical Review Requirements (``CMS Rule''), 86 FR 64996,
65666 (Nov. 19, 2021).
\26\ Id. at 65060.
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CMS's revised definition of ``interactive telecommunications
systems,'' however, now also includes two-way, real-time audio-only
communication technology under certain limited circumstances,
limitations that are designed to maintain audio-video equipment as the
general standard and only authorize audio-only equipment when both
necessary and appropriate. First, to allow the use of audio-only
equipment, the medical services at issue must be ``furnished for
purposes of diagnosis, evaluation, or treatment of a mental health
disorder.'' CMS recognized that, for many mental health services,
visualization between the patient and clinician may be less critical to
provision of the service: ``[M]ental health services are different from
other services because they principally involve verbal exchanges
between patient and practitioner.'' \27\
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\27\ Id. at 65061.
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CMS also responded to comments requesting that audio-only
technology be permitted for a broader scope of Medicare telehealth
services. CMS distinguished ``services furnished for purposes of
diagnosis, evaluation, or treatment of a mental health disorder'' from
other services, and specified that the scope of the audio-only policy
is limited to mental health disorders.\28\ CMS also acknowledged that
``[T]here may be particular instances where visual cues may help a
practitioner's ability to assess and treat patients with mental health
disorders, especially where opioids or mental health medications are
involved . . . .'' \29\
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\28\ Id.
\29\ Id.
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Second, to allow the use of audio-only equipment, the mental health
services must be provided ``to a patient in their home.'' CMS reasoned
that other sites at which a patient generally receives telehealth
services are ``medical settings that are far more likely to have access
to reliable broadband internet service. When a patient is located at
one of these . . . sites, access to care is far less likely to be
limited by access to broadband that facilitates a video connection. In
contrast, access to broadband, devices, and user expertise is less
likely to be available at a patient's home.'' \30\ CMS, however,
adopted a flexible understanding of ``home'': ``[O]ur definition of
home can include temporary lodging such as hotels and homeless shelters
as well as locations a short distance from the [patient's] home'' (if
the patient, ``for privacy or other personal reasons, chooses to travel
a short distance ways from the exact home location during a telehealth
service . . . .'').\31\
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\30\ Id. at 65060.
\31\ Id. at 65059.
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Third, to allow the use of audio-only equipment, the distant site
physician or practitioner must be ``technically capable'' of meeting
the usual two-way, audio-video interactive communication standard. And,
relatedly, the patient must ``not [be] capable of, or . . . not consent
to, the use of video technology.'' In other words, ``because it is
generally appropriate to require the use of two-way, real-time audio/
video communications technology,'' \32\ the distant practitioner
engaging in telehealth must make the option of
[[Page 12879]]
audio-visual communication available to the patient. The audio-only
option may only be used if the patient ``is unable to use, does not
wish to use, or does not have access to two-way, audio/video
technology.'' \33\
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\32\ Id. at 65062.
\33\ Id. at 65060.
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Because the proposed rule's definitions of ``practice of
telemedicine'' and ``telemedicine encounter'' \34\ are linked to 42 CFR
410.78(a)(3)'s definition of ``interactive telecommunications system,''
they would also incorporate that definition's requirements.
Accordingly, under most circumstances, a remote practitioner would have
to be using both audio and video equipment permitting two-way, real-
time interactive communication with a patient to be part of a
``telemedicine encounter'' in the course of the ``practice of
telemedicine.'' If that practitioner, however, met all of Sec.
410.78(a)(3)'s various requirements for using audio-only equipment
(mental health services, etc.), then that practitioner could engage in
the ``practice of telemedicine'' and conduct ``telemedicine
encounters'' as defined in the proposed rule using audio-only
equipment--so long as that practitioner also complied with the proposed
rule's other requirements and doing so was medically appropriate and
also complied with relevant State and Federal law.
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\34\ Proposed 21 CFR 1300.04().
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The current regulatory definition of the ``practice of
telemedicine'' requires that it be conducted ``in accordance with
applicable Federal and State laws.'' \35\
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\35\ 21 CFR 1300.04(i). The CSA and DEA's regulations only
define the ``practice of telemedicine'' for their own purposes. DEA
is not attempting to define what constitutes appropriate
telemedicine in other contexts. Thus, the proposed rule would not
determine when substances that are not controlled may be
appropriately prescribed via telemedicine or the nature of
appropriate remote medical treatment more generally. Moreover, the
proposed rule would not create any additional regulatory
requirements for the other categories of telemedicine authorized by
the CSA under 21 U.S.C. 802(54).
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Proposed paragraph (k) would define what constitutes a ``qualifying
telemedicine referral'' for the purposes of this rulemaking. This
definition would clarify the nature of the medical evaluation
relationship that is required for the referral to enable the
prescribing practitioner to issue prescriptions in excess of the 30-day
limit as described in proposed Sec. 1306.31(c)(2). This definition
would require the referring practitioner to have conducted at least one
medical evaluation of the patient in the physical presence of the
referring practitioner, without regard to whether portions of the
evaluation are conducted by other practitioners. This means that if
multiple practitioners were physically present during the medical
evaluation, they would all have the ability to issue a qualifying
telemedicine referral under this section as long as they otherwise
complied with DEA regulations. Any other referrals, such as those
predicated on a telemedicine visit exclusively, would not constitute a
qualifying telemedicine referral. Both the referring practitioner and
the prescribing practitioner would be required to maintain records of
the referral.
DEA proposes to add paragraph (n) to define the term ``telemedicine
prescription'' as a prescription issued pursuant to Sec. 1306.31 by a
physician, or a ``mid-level practitioner'' as defined in 21 CFR
1300.01(b), engaging in the practice of telemedicine as defined in 21
CFR 1300.04(j).
DEA proposes to add paragraph (o) to add a definition of the term
``telemedicine relationship established during the COVID-19 public
health emergency.'' Such a relationship exists if the practitioner has
not conducted an in-person medical evaluation of the patient and has
prescribed one or more controlled medications based on telemedicine
encounters during 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 and pursuant to the designation
pursuant to that public health emergency on March 16, 2020, by the
Secretary of Health and Human Services, with concurrence of the Acting
DEA Administrator, that the telemedicine allowance under section
802(54)(D) applies to all schedule II-V controlled substances in all
areas of the United States.\36\ Other proposed provisions, discussed in
detail below, would use this defined term to facilitate a six-month
transition of doctor-patient relationships from the use of telehealth
prescribing flexibilities established during the COVID-19 public health
emergency to the use of the prescribing authority set forth in this
proposed rule.
---------------------------------------------------------------------------
\36\ See Xavier Becerra, Renewal of Determination That a Public
Health Emergency Exists; 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; see
also Thomas W. Prevoznik, DEA Dear Registrant letter, Drug
Enforcement Administration (March 31, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Fina
l)%20+Esign.pdf.
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Finally, DEA proposes a technical amendment to remove from its
regulations the ``[t]emporary definition of the practice of
telemedicine'' found at 21 CFR 1300.04(j).
B. Part 1304: Records of Registrants
As the Ryan Haight Act recognized, the remote prescribing of
controlled medications through the internet to patients who have not
been seen in person by the prescriber presents a heightened risk of
diversion. Thus, DEA is proposing to amend 21 CFR part 1304 to impose
certain additional recordkeeping requirements for controlled substance
prescriptions issued pursuant to telemedicine encounters.\37\ These
proposed requirements would significantly enhance DEA's ability to both
detect and investigate the potential misuse of telemedicine to
prescribe controlled substances for other than legitimate medical
purposes.
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\37\ DEA notes that practitioners who are authorized to engage
in the practice of telemedicine under other statutory authority in
21 U.S.C. 802(54), such as IHS practitioners authorized under 21
U.S.C. 802(54)(C), would not be subject to these proposed additional
recordkeeping requirements.
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In particular, proposed Sec. 1304.03(i) would require a
practitioner to maintain a written or electronic log for each
prescription issued pursuant to a telemedicine encounter indicating the
date the prescription was issued; the full name and address of the
patient; the drug name, strength, dosage form, quantity prescribed, and
directions for use; the address at which the practitioner, and the city
and State in which the patient, is located during the telemedicine
encounter; if issued through a qualifying telemedicine referral, the
name and National Provider Identifier (``NPI'') of the referring
practitioner, a copy of the referral and any communications shared
pursuant to Sec. 1306.31(d)(3)(i)-(iii); and all efforts to comply to
access the PDMP system (and, if employed by the Department of Veterans
Affairs, Department of Veterans Affairs internal prescription
database). Proposed Sec. 1304.03(j) would require practitioners to
maintain copies of all qualifying telemedicine referrals they issue.
Proposed Sec. 1304.03(k) would set requirements for maintaining
records related to medical evaluations conducted by a prescribing
practitioner with the patient and another DEA practitioner physically
together at the other end of an audio-video link pursuant to Sec.
1306.31(d)(2). Paragraph (1) would require an individual practitioner
who participates in such a medical evaluation as the prescribing
practitioner to maintain, for each such medical evaluation, the data
and time of
[[Page 12880]]
the evaluation; the NPI of the DEA-registered healthcare worker
physically present with the patient; the address at which the
prescribing practitioner is located during the telemedicine encounter;
and the address at which the DEA-registered healthcare worker is
physically present with the patient during the medical evaluation.
Likewise, paragraph (2) requires an individual practitioner who
participates in such a medical evaluation as the DEA-registered
healthcare worker physically present with the patient to maintain, for
each such medical evaluation, the data and time of the evaluation; the
address at which the prescribing practitioner is located during the
telemedicine encounter; the NPI of the prescribing practitioner; and
the address at which the DEA-registered healthcare worker is physically
present with the patient during the medical evaluation.
Proposed 1304.04(i) would require all such records to be maintained
at the registered location of the practitioner's 21 CFR
1301.13(e)(1)(iv) dispensing registration. Put differently, a
practitioner using telemedicine to prescribe controlled medications may
operate out of multiple locations. Thus, to avoid any confusion and
ensure that DEA investigators are able to locate the records when
necessary, proposed Sec. 1304.04(i) would specify that the required
records must be maintained at the registered location of the
practitioner's registration under 21 CFR 1301.13(e)(1)(iv) in digital
or paper form that is readily accessible.
If DEA instead were to require records to be maintained in the
State(s) where telemedicine patients are located, practitioners could
theoretically have to maintain telemedicine records in over 50
different locations (if they had a nationwide practice), including
states in which they may not retain a physical office location. This
would be burdensome for both the practitioner and DEA investigators. In
particular, the consolidation of the records under this provision is
necessary for DEA investigators because the detection of patterns of
diversion is often contingent upon looking comprehensively at a
practitioner's prescribing habits and recordkeeping. This process would
become impracticable if investigators had to obtain records from 50
different locations across the country, resulting in significant
administrative waste. Ensuring ready access to this information in a
consolidated manner in a central location during investigations would
facilitate DEA's ability to detect patterns of potential illegitimate
prescribing and thus enhance its ability to prevent further diversion
of controlled medications. Practically, DEA does not anticipate that
the consolidation of the records would be overly burdensome for
practitioners as the majority of practitioners now maintain electronic
records.
Requiring this recordkeeping would also serve to reinforce the
obligation of practitioners who practice telemedicine to prescribe
within the limited circumstances set forth in the proposed rule.
Moreover, medical records that include the name of any DEA-registered
healthcare worker in the physical presence of the patient during a
telemedicine encounter would be an important tool in subsequent
investigations as that information is often not otherwise recorded by
the prescribing practitioner. Requiring the NPI would ensure physically
present DEA-registered healthcare workers are properly identified, as
many States may have several practitioners with the same name.
Investigations can often occur years after the telemedicine encounter,
and these recordkeeping provisions would reduce the risk of
investigators missing crucial information because of fading memories or
faulty/incomplete records.
C. Part 1306: Prescriptions
DEA proposes to amend part 1306 by adding Sec. 1306.05(i), which
would require all telemedicine prescriptions issued pursuant to Sec.
1306.31 to include on the face of the prescription, or within the
prescription order if prescribed electronically, that the prescription
was issued via a telemedicine encounter.
The proposed rule would also amend part 1306 by adding Sec.
1306.31, which would provide a number of requirements that a
practitioner would have to satisfy to issue a prescription for a
controlled substance as a result of a telemedicine encounter.
Consistent with the text of the Ryan Haight Act and other parts of the
CSA, controlled substances only may be prescribed for legitimate
medical purposes by practitioners acting in the usual course of
professional practice. Proposed Sec. 1306.31(a)(1) is one way the
proposed rule fulfills that mandate.
First, proposed Sec. 1306.31(a)(1) would make clear that
telemedicine may only be used to issue a prescription if that
prescription is issued pursuant to a telemedicine encounter and is
issued for a legitimate medical purpose by a practitioner acting in the
usual course of professional practice. As discussed above, the proposed
rule would define ``telemedicine encounter'' as a communication between
a practitioner and a patient using an interactive telecommunications
system referred to in 42 CFR 410.78(a)(3), while the practitioner is
engaged in the practice of medicine as defined in proposed Sec.
1300.04(j).\38\ Thus, under proposed Sec. 1306.31(a)(1), for a
prescription to be issued to a patient using telemedicine, among other
things, the prescription would need to arise out of a telemedicine
communication directly between the prescribing practitioner and that
patient.\39\
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\38\ Proposed 1300.04(o).
\39\ Proposed 1306.31(a)(6) also broadly requires that a
practitioner comply with the requirements of State law when
prescribing pursuant to a telemedicine encounter.
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Proposed Sec. 1306.31(a)(2) would require all practitioners who
wish to engage in the practice of telemedicine to be located in a
State, Territory, or possession of the United States; the District of
Columbia; or the Commonwealth of Puerto Rico at the time the relevant
telemedicine encounter occurs. In other words, a practitioner cannot
use telemedicine to prescribe controlled medications while that
practitioner is located outside the United States.
Proposed Sec. 1306.31(a)(3)(i) would require that a practitioner
using telemedicine to prescribe a controlled substance be authorized to
prescribe that basic class of controlled substance under registrations
in the State where the practitioner is located, as well as the State
where the patient is located.
Proposed Sec. 1306.31(a)(4), like proposed Sec. 1306.05(i)
described above, would require the practitioner to include on a
prescription issued pursuant to a telemedicine encounter that the
prescription has been issued based on a telemedicine encounter. Thus,
when reviewing pharmacy prescription records, DEA investigators could
readily distinguish prescriptions issued pursuant to telemedicine
encounters from those issued using their dispensing registrations for
non-telemedicine prescriptions--giving investigators greater ability to
detect abusive patterns in the use of telemedicine.
As discussed above, and as stated in proposed Sec.
1306.31(c)(1)(i), the proposed rule would only authorize practitioners
to use telemedicine to prescribe non-narcotic controlled substances in
schedules III-V. Excluding schedule II controlled substances and all
narcotic controlled substances \40\ is consistent with the limitations
Congress placed on the use
[[Page 12881]]
of telemedicine. Congress directed DEA and HHS to authorize the use of
telemedicine only when doing so is ``consistent with effective controls
against diversion and otherwise consistent with the public health and
safety'' 21 U.S.C. 802(54)(G), but permitted DEA and HHS to determine
the precise circumstances that were most appropriate. Given the ongoing
opioid epidemic at the time of publishing, DEA believes that allowing
for the prescription of any schedule II substances or the general
prescription of narcotic controlled substances \41\ as a result of
telemedicine encounters would pose too great a risk to the public
health and safety. However, if the prescribing practitioner has
received a qualifying telemedicine referral under proposed Sec.
1300.04(k) for that patient from a referring practitioner who has
conducted a medical evaluation as described in paragraph proposed Sec.
1306.31(d)(3), the prescription may be issued for any controlled
substance that they are otherwise authorized to prescribe under
applicable laws and regulations.
---------------------------------------------------------------------------
\40\ As noted above, DEA is addressing the prescribing of
certain narcotic substances via telemedicine for the treatment of
opioid use disorder in a separate rulemaking.
\41\ As noted above, DEA is addressing the prescribing of
certain narcotic substances via telemedicine for the treatment of
opioid use disorder in a separate rulemaking.
---------------------------------------------------------------------------
Proposed Sec. 1306.31(c)(2) would also combat diversion by
requiring that the prescribing of controlled substances as a result of
a telemedicine encounter be initially time-limited for each patient
(unless conducted by VA practitioners). Practitioners could prescribe
controlled medications to a patient using telemedicine only for a
period of 30 days before a medical evaluation of the nature described
below would be required, starting from the date of issuance of the
first prescription pursuant to a telemedicine encounter. The
prescribing practitioner would be permitted to issue multiple
prescriptions for the patient, provided, however, that the
prescriptions do not authorize the dispensing of more than a total
quantity of a 30-day supply of the controlled medication. Once that
prescribing period ends, if the patient does not receive a medical
evaluation as described below, the practitioner would no longer be able
to prescribe any controlled medication to that patient as a result of a
telemedicine encounter until the medical evaluation has taken place.
To continue prescribing beyond the 30-day window, the prescribing
practitioner would have to either see the patient for an in-person
medical evaluation provided in Sec. 1306.31(d)(1)--removing the
prescription from the bounds of the Ryan Haight Act's telemedicine
restrictions--or receive a medical evaluation under one of the schemes
provided in Sec. 1306.31(d)(2) and (d)(3). Under the scheme provided
in (d)(2), the patient would not be in the physical presence of the
prescribing practitioner, but the patient would have to be being
treated by, and in the physical presence of, another DEA-registered
practitioner. This other non-prescribing practitioner would have to be
acting in the usual course of professional practice. Also, the
prescribing practitioner, the DEA-registered practitioner on site with
the patient, and the patient would have to participate in an audio-
video conference simultaneously (i.e., these individuals must
participate in a two-way, simultaneous interactive communication with
both audio and video for this medical evaluation even if audio-only
communication had been authorized under the standard of 42 CFR
410.78(a)(3) for prior communications between the prescribing
practitioner and the patient). Thus, even though the prescribing
practitioner would not be conducting an in-person evaluation
themselves, they could rely on the in-person evaluation of the on-site
practitioner--and remotely observe this evaluation via video and
audio--when determining whether to continue prescribing to the patient.
Alternatively, the requirement of a medical evaluation is satisfied
when the prescribing practitioner receives a qualifying telemedicine
referral from a DEA registered practitioner under Sec. 1306.31(d)(3).
Under this scheme, the patient must have received a face-to-face
evaluation from a DEA registered practitioner, referred to as the
referring practitioner. The referring practitioner may then issue a
written qualifying telemedicine referral to the prescribing
practitioner based on the diagnosis, evaluation, or treatment that was
provided for the medical issue upon which the medical evaluation was
predicated pursuant to paragraphs (i) and (iii). Moreover, under
paragraph (ii), the referring practitioner must communicate the results
of the medical evaluation which include any diagnosis, evaluation, or
treatment to the prescribing practitioner, prior to the prescribing
practitioner issuing a prescription. If the prescribing practitioner
issues the prescription to the patient prior to receiving the
information provided in (ii), this does not qualify as a medical
evaluation for the purposes of Sec. 1306.31(d) and the patient must
receive a medical evaluation in the manner described in paragraph
(d)(1) or (d)(2).
For example, the following scenarios illustrate procedurally how
this qualifying telemedicine referral would operate:
Example 1
A patient travels to receive a medical evaluation in the presence
of their family physician. The physically present practitioner conducts
a medical evaluation and provides a diagnosis, an evaluation, or
treatment to the patient. The physically present practitioner
determines that the patient would benefit from specialized care
provided by a practitioner across the country (prescribing
practitioner). The physically present practitioner issues a written
referral to the prescribing practitioner via an appropriately secured
electronic communication, and includes in the communication the reason
for the referral, a copy of the medical record, as well as a
description of the diagnosis, evaluation, and treatment of the patient
prior to the prescribing practitioner. The prescribing practitioner
reviews this information, engages in a telemedicine encounter with the
patient, and issues a prescription for a controlled medication to the
patient.
Example 2
A patient who is insured with, and receives treatment from, a
medical group (such as Kaiser Permanente) travels to a local medical
office to receive a medical evaluation in the physical presence of a
practitioner. The physically present practitioner conducts a medical
evaluation and provides a diagnosis, an evaluation, or treatment to the
patient. The physically present practitioner determines that the
patient would benefit from specialized care provided by a practitioner
in the same medical group (prescribing practitioner). The physically
present practitioner issues a written referral to the prescribing
practitioner via an appropriately secured electronic communication, and
includes in the communication the reason for the referral, a copy of or
link to the medical record, as well as a description of the diagnosis,
evaluation, and treatment of the patient prior to the prescribing
practitioner. The prescribing practitioner reviews this information,
engages in a telemedicine encounter with the patient, and issues a
prescription for a controlled medication to the patient.
In both examples, the physically present practitioner issued a
qualifying telemedicine referral to the prescribing
[[Page 12882]]
practitioner. The physically present practitioners issued a written
referral, based on the medical evaluation that was conducted by the
physically present practitioner, and shared all pertinent medical
information as required under proposed Sec. 1306.31(d)(3) with the
prescribing practitioner. The prescription issued by the prescribing
practitioner may be for any controlled medication that they are
otherwise authorized to prescribe under applicable laws and regulations
under proposed Sec. 1306.31(c)(1). These examples are not intended to
be exhaustive, and represent only some of the possible scenarios upon
which a qualifying telemedicine referral may be issued.
Once a medical evaluation meeting the specified criteria is
performed, the proposed rule would allow a practitioner to continue
prescribing a controlled medication to a patient without additional
evaluations, so long as doing so was consistent with legitimate medical
purposes and a subsequent evaluation was not required by law.
Proposed paragraph (e) would require practitioners to review
available information about past prescriptions to a particular patient.
Proposed paragraph (e)(1) would require the practitioner, if employed
by the Department of Veterans Affairs, to review the Department of
Veterans Affairs' internal prescription database for data regarding any
controlled medication prescriptions issued to the patient in the last
year, or, if less than a year of data is available, in the entire
available period. Proposed paragraph (e)(1) would require all
practitioners prescribing pursuant to Sec. 1306.31 to review the PDMP
data for the State in which the patient is located, where available,
for the last year. PDMPs have proven to be an invaluable tool in
preventing diversion, allowing practitioners to identity patients whose
prescription history suggests that they are seeking controlled
medications for other than legitimate medical needs--either because
they misuse controlled medications or may be selling them to others.
Given the heightened risk of diversion in the telemedicine context, DEA
believes it is appropriate to require practitioners to review PDMP data
and, for VA practitioners, the VA's own centralized health information
system, before issuing a telemedicine prescription.
Proposed paragraph (e)(2)(i) would require, in those circumstances
where the PDMP system is non-operational, practitioners to limit their
prescriptions to patients to no more than a 7-day supply until they are
able to access the PDMP system again. This limit applies until the
practitioners are able to access the PDMP system, complete their review
of the patient's prior prescription history, and verify the nature of
prescriptions when applicable. Paragraph (e)(2)(ii) would require the
practitioner to gain access to the PDMP system and conduct appropriate
reviews within 7 days of the telemedicine encounter, and paragraph
(e)(2)(iii) would require the practitioner to record the attempts to
access the PDMP and (if applicable) the Department of Veterans Affairs
internal prescription database pursuant to Sec. 1304.03(i). If the
practitioner failed to obtain the PDMP (or, if employed by the
Department of Veterans Affairs, Department of Veterans Affairs internal
prescription database) data, the dates and times that the practitioner
attempted to gain access, the reason why the practitioner was unable to
gain access, and any follow-up attempts made to gain access to the
system. The 7-day prescription can be refilled upon successful review
of the PDMP by the practitioner, as long as the prescriptions together
do not exceed a 30-day supply.
If the practitioner otherwise completes their review of the PDMP
system pursuant to paragraph (e)(2)(ii), or is otherwise able to comply
with all relevant requirements in paragraph (e)(1), proposed paragraph
(e)(3) would authorize practitioners to prescribe ``no more than a 30-
day supply across all such prescriptions'' until the practitioner has
conducted the required medical evaluation. Put another way, this
provision would allow the doctor to provide up to a thirty-day supply
in any combination of prescriptions and prohibits the doctor from going
beyond that until the medical evaluation is conducted. This supply may
include dosages that are titrated up or down depending on the patient's
response to the medication and the practitioner's medical judgment,
however, it may not exceed a supply sufficient to treat the patient for
more than 30 days.
If the prescribing practitioner does not conduct a medical
evaluation as described in proposed paragraphs (d)(1) or (d)(2) within
a period of 30 calendar days, the practitioner would not be authorized
to issue any subsequent prescriptions to that patient under proposed
paragraph (f). This requirement would not apply to a practitioner who
has a telemedicine relationship established during the COVID-19 public
health emergency with the patient, as defined in Sec. 1300.04(g), or
to a practitioner employed by the Department of Veterans Affairs when
prescribing to a patient of the Department of Veterans Affairs health
system.
Proposed Sec. 1306.31(g) would require all prescriptions issued as
a result of telemedicine encounters to be consistent with all other
requirements of this part. This provision would clarify that unless
otherwise specified, practitioners authorized to prescribe controlled
substances in the manner described in this rulemaking would
nevertheless be subject to the regulatory requirements imposed by Sec.
1306.31 and DEA registrations generally.
D. Request for Comments
With respect to the proposed rule, DEA invites comments concerning
whether any clarifications or other regulatory provisions are warranted
to ensure appropriate access to care, consistent with effective
controls against diversion and otherwise consistent with the public
health and safety. To that end, DEA is requesting comments on whether
the rule should limit the issuance of prescriptions for controlled
medications to the FDA-approved indications contained in the FDA-
approved labeling for those medications. DEA invites comments on the
proposed practitioner recordkeeping obligations. Additionally, based on
the available information, in order to balance benefits and risks to
individual and public safety, DEA is proposing a 30-day maximum supply
under proposed Sec. 1306.31(c)(2) for the controlled substance being
prescribed via telemedicine prior to an in-person evaluation being
conducted. DEA seeks comment, including data from research and clinical
practice, that provides evidence that an alternate maximum day supply
would be more appropriate than the one proposed in this rulemaking. DEA
also seeks comments about additional safeguards or flexibilities that
should be considered with respect to this rule.
Moreover, DEA invites comments on whether the Notice of Proposed
Rulemaking, entitled ``Expansion of Induction of Buprenorphine via
Telemedicine Encounters'' (RIN 1117-AB78), published elsewhere in this
issue of the Federal Register, should be combined with this rulemaking
when publishing the Final Rule as both documents refer to prescribing
via telemedicine pursuant to 21 U.S.C. 802(54)(G).
This rule is designed to ensure that patients do not experience
lapses in care. It is also deigned to ensure continuity of care under
the current telehealth flexibilities in place as a result of the COVID-
19 public health emergency. The COVID-19 public
[[Page 12883]]
health emergency is set to expire on May 11, 2023. DEA and HHS have
provided for a notice-and-comment period of 30 days so that they have
an opportunity to fully review and respond to any submissions.
IV. Regulatory Analyses
Executive Orders 12866 (Regulatory Planning and Review), 13563
(Improving Regulation and Regulatory Review)
This proposed 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 $100 million or more 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, 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 novel legal
or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the E.O.
The economic, interagency, budgetary, legal, and policy
implications of this proposed rule have been examined, and it has been
determined that it is a significant regulatory action, but not an
economically significant regulatory action having an annual effect on
the economy of $100 million or more, under E.O. 12866. Accordingly,
this rule has been submitted to the OMB for review.
DEA expects that this proposed rule would result in a cost savings
of $3,762,089 per year. Additionally, the proposed rule is estimated to
decrease transfers to the federal government by $11,628 per year. Fees
paid to the federal government are considered transfer payments and not
costs.\42\ The analysis of cost savings, costs, transfers, and benefits
is provided below.
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\42\ OMB Circular A-4.
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Regulatory Alternatives Considered
DEA considered four alternatives, including the selected
alternative: (1) an alternative only allowing the practice of
telemedicine pursuant to an application and issuance of a ``special
registration'' allowing such practice; (2) an alternative only allowing
the practice of telemedicine pursuant to a special registration
allowing such practice and limiting special registration to the
prescribing of non-narcotic controlled substances to patients located
in rural areas, (3) an alternative only allowing the practice of
telemedicine pursuant to a special registration allowing such practice
but requiring patients to be located at a qualified originating site,
and (4) the selected alternative.
First, DEA considered allowing the practice of telemedicine
pursuant to an application and issuance of a ``special registration''
allowing such practice. Upon further consideration, this alternative
was deemed potentially burdensome for both prospective telemedicine
providers and patients. Therefore, DEA decided against this
alternative.
Second, DEA considered placing an additional geographic limitation
on the circumstances under which controlled substances can be
prescribed pursuant to a special registration for telemedicine. Under
this alternative, a telemedicine encounter that gives rise to the
issuance of a prescription under a special registration for
telemedicine would have to be with a patient in a rural location based
on the CMS definition of ``rural area'' \43\ (unless the patient is
being treated by the Department of Veterans Affairs (``VA'')). More
specifically, under this alternative, prescriptions would have to be
issued to patients who reside in such ``rural areas.'' Patients
residing in rural areas were believed to face higher burdens when
obtaining in-person medical evaluations and thus have a legitimate need
for increased access to controlled medication prescriptions issued via
telemedicine. If this alternative were implemented, the patients served
would be limited to those residing in rural areas. However, upon
further evaluation of the need for telemedicine and the risk of
diversion, DEA decided not to propose this ``rural area'' requirement.
DEA understands patients in non-rural areas can also be underserved and
have a legitimate need for increased access to prescriptions issued via
telemedicine. Therefore, DEA decided to include patients in non-rural
areas in the proposed rulemaking.
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\43\ In its regulations, CMS defines a rural area as an area
located outside an urban area, or a rural census tract within a
Metropolitan Statistical Area as determined under the most recent
version of the Goldsmith modification as determined by the Office of
Rural Health Policy of the Health Resources and Services
Administration. See 42 CFR 414.605.
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Third, DEA considered requiring patients be located at a qualifying
``originating site'' during the relevant telemedicine encounter. Under
this alternative, patients (except patients being treated by VA
practitioners) would be required to be located at one of a defined set
of ``originating sites'' when receiving treatment leading to a
controlled substance prescription as a result of a telemedicine
encounter. CMS regulations at 42 CFR 410.78(b)(3) list twelve types of
locations described as ``originating sites'' for purposes of Medicare
Part B payment. DEA considered including a subset of those locations as
qualifying originating sites for the special registration for
telemedicine. Specifically, this alternative would include the
locations listed in section 410.78(b)(3)(i)-(ix): offices of physicians
or practitioners,\44\ critical access hospitals, rural health clinics,
federally qualified health centers, hospitals, hospital-based or
critical access hospital-based renal dialysis centers (including
satellites), skilled nursing facilities, community mental health
centers, and renal dialysis facilities.\45\ The intent of this
alternative was to expand the range of telemedicine treatment that
practitioners may engage in under the CSA, while also mitigating,
[[Page 12884]]
to the extent practicable, the risk of diversion posed by this
expansion in controlled substance prescribing. With this in mind, this
alternative would stipulate that the originating site at which patients
must be located during treatment must be a clinical setting, be capable
of handling standard intake processing of patients, and have
appropriate medical personnel available to provide support to the
distant prescribing practitioner, as necessary. However, upon further
consideration, this alternative was deemed too restrictive, with the
potential of creating a substantial burden on prospective patients.
Therefore, DEA decided against this alternative.
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\44\ The term ``practitioner,'' as used in this section of CMS
regulations, differs from the definition of that term given in the
CSA, and includes the following: physicians, physician assistants,
nurse practitioners, clinical nurse specialists, nurse-midwives,
clinical psychologists, clinical social workers, registered
dietitians or nutrition professionals, and certified registered
nurse anesthetists. 42 CFR 410.78(b)(2). To be clear, under this
alternative, these are persons whose offices would qualify as
originating sites for a special registration for telemedicine, but
not all of these persons would be eligible to obtain and treat
patients under a special registration for telemedicine.
\45\ Section 410.78 requires that in addition to qualifying as
one of these types of facilities, the originating site must meet
certain geographic requirements over and above the geographic
restrictions that are part of the definition of some types of
facilities. This alternative would not require that a facility meet
these additional geographic requirements in order to qualify as an
originating site under a special registration for telemedicine, but
would require that it meet the restrictions imposed in the
underlying definition of the facility. So, for example, to qualify
as a rural health clinic and be an originating site for patients
treated under a special registration for telemedicine, a facility
would have to meet the requirements of 42 U.S.C. 1395x(aa)(2), but
not the requirements of 21 CFR 410.78(b)(4).
---------------------------------------------------------------------------
Finally, DEA is proposing the selected alternative, which would not
limit prescriptions issued as a result of a telemedicine encounter to
prescriptions issued pursuant to a special registration regime, to
patients who reside in ``rural areas,'' or to patients located at a
qualifying originating site. The selected (proposed) alternative is
less restrictive and likely to benefit more patients. Below is a
detailed analysis of the selected alternative.
Analysis of Costs, Cost Savings, Benefits, and Transfers
There are minimal costs and substantial cost savings, other
benefits, and transfers associated with this proposed rulemaking. As
discussed above, this proposed rule describes the circumstances under
which, pursuant to 21 U.S.C. 802(54)(G), a practitioner may prescribe
controlled substances to patients whom the practitioner has not
evaluated in person. This rulemaking would not impose any new
requirements on practitioners authorized to practice telemedicine under
other statutory exceptions in 21 U.S.C. 802(54), such as IHS, who are
authorized to engage in the practice of telemedicine under a different
statutory paragraph, 802(54)(C).
Under this proposed rule, practitioners would be allowed to issue
prescriptions via telemedicine for schedule III-V non-narcotic
controlled medications to the extent otherwise authorized by their DEA
registration(s).\46\
---------------------------------------------------------------------------
\46\ As noted above, DEA is addressing the prescribing of
certain narcotic substances via telemedicine for the treatment of
opioid use disorder in a separate rulemaking.
---------------------------------------------------------------------------
As also discussed earlier, the proposed rule specifies the
circumstances under which practitioners may prescribe controlled
substances, pursuant to 21 U.S.C. 802(54)(G), to patients whom the
practitioner has never evaluated in person, including that:
Such prescriptions be in accordance with applicable
Federal and State laws; and
Such practitioners possess an active DEA dispensing
registration issued pursuant to 21 CFR 1301.13(e)(1)(iv) in the State
in which the practitioner is located (unless exempted).
Consistent with effective controls against diversion and otherwise
consistent with the public health and safety, the proposed rule also
specifies requirements related to recordkeeping and prescriptions. DEA
estimates that there would be no additional infrastructure cost for
patients or providers associated with this proposed rule, as DEA has
concluded that most patients and providers already possess or have
ready access to a telecommunications system meeting the requirements of
the proposed rule. In addition, there is potential for an added risk of
diversion from more practitioners having the authority to prescribe
schedule III-V non-narcotic controlled substances. An analysis of all
costs is detailed below.
1. Recordkeeping
This proposed rule would require a practitioner to maintain a
written or electronic log for each prescription issued pursuant to a
telemedicine encounter indicating the date the prescription was issued;
the full name and address of the patient; the drug name, strength,
dosage form, quantity prescribed, and directions for use; the address
at which the practitioner, and the city and State in which the patient,
are located during the telemedicine encounter; if issued through a
qualifying telemedicine referral, the name and NPI of the referring
practitioner, a copy of the referral and any communications shared
pursuant to Sec. 1306.31(d)(3)(i)-(iii); and all efforts to comply to
access the PDMP system (and, if employed by the Department of Veterans
Affairs, Department of Veterans Affairs internal prescription
database).
DEA believes that these recordkeeping requirements may result in
additional recordkeeping costs; but, given that the recordkeeping
required by proposed 21 CFR 1304.03(i) is not extensive and this
information is expected to be readily available, DEA does not
anticipate it imposes a major burden on registrants.
2. Prescriptions
First, this proposed rule would require all prescriptions issued
pursuant to a telemedicine encounter to note on the face of any
prescription, or within the prescription order if prescribed
electronically, issued pursuant to Sec. 1306.31 that the prescription
was issued via a telemedicine encounter. DEA anticipates any added cost
associated with this requirement would be minimal, as minimal
additional time would be required to make this notation.
Second, as discussed above, this proposed rule would generally
limit practitioners to use telemedicine to prescribe non-narcotic
controlled substances in schedules III-V only for a period of 30 days,
unless such a medical evaluation for the purposes of this section is
conducted pursuant to Sec. 1306.31 paragraph (d)(1), (d)(2), or
(d)(3). As DEA is proposing to amend its regulations to specify
circumstances under which practitioners may prescribe controlled
substances, pursuant to 21 U.S.C. 802(54)(G), where there is no
existing regulation, there is no cost associated with this provision.
Finally, this proposed rule would require all practitioners
prescribing pursuant to Sec. 1306.31 to review the PDMP data for the
State in which the patient is located, where available, for the last
year. DEA estimates many practitioners already check PDMP prior to
issuing a prescription for a controlled substance for a variety of
reasons, and therefore, any additional cost is minimal. However, DEA
welcomes any comment on this estimate, including specific burden
estimates, if any.
3. Risk of Diversion
This proposed rulemaking allows practitioners to issue
prescriptions for schedule III-V non-narcotic controlled substances to
the extent otherwise authorized by their DEA registration(s).\47\
---------------------------------------------------------------------------
\47\ As noted above, DEA is addressing the prescribing of
certain narcotic substances via telemedicine for the treatment of
opioid use disorder in a separate rulemaking.
---------------------------------------------------------------------------
Such substances are subject to diversion and misuse, and allowing
practitioners an increased ability to prescribe these substances via
telemedicine presents the potential for the increased diversion and
misuse of these substances. DEA believes that the benefits of increased
availability for treatment outweigh the dangers of a potential increase
in diversion--so long as prescribers using telemedicine adhere to the
safeguards inherent in the requirements of the proposed rule.
4. Other Potential Costs
DEA also examined the cost of technology for telemedicine, both
capital investment and operational expenses, in order to use the
proposed telemedicine authority. DEA believes
[[Page 12885]]
that these initial investments have already been made by the
practitioners most likely to engage in telemedicine pursuant to 21
U.S.C. 802(54)(G), and that there would be no additional technology or
infrastructure cost to these practitioners. For example, VA
practitioners already make significant use of telehealth services under
existing authorities. Thus, VA practitioners are already expected to
have the necessary technology and broadband access in order to
prescribe controlled medications utilizing telehealth services in a
manner consistent with the proposed rule. Therefore, DEA believes that
there are no additional technology or infrastructure costs associated
with this proposed rulemaking because all stakeholders would be
leveraging current resources.
5. Summary of Costs
In summary, DEA estimates any cost associated with this rule is
minimal.
B. Cost Savings, Transfers, and Benefits
The following sections summarize the expected cost savings and
change in transfers related to telemedicine, pursuant to 21 U.S.C.
802(54)(G), that are realized by both VA and non-VA practitioners.
1. Cost Savings for VA Practitioners
To quantify the expected cost savings, DEA used data provided by
the VA regarding the number of VA health care professionals in FY2018
who have seen a patient via telehealth under existing telemedicine
authorities, prescribed a controlled medication, and had not completed
an in-person appointment with that patient. There were 21,046
encounters identified in FY2018 where a provider prescribed a schedule
III-V controlled medication via telemedicine without having previously
completed an in-person appointment under existing CSA telemedicine
authorities.\48\ These encounters were completed by 1,222 VA health
care professionals. Because this proposed rule would authorize VA
providers to prescribe schedule III-V non-narcotic controlled
substances without requiring the veteran to be physically located in a
VA clinic, these 21,046 appointments have the potential to be conducted
in the veteran's home after promulgation of this rule. The VA provided
DEA with further data on the various cost savings associated with
conducting these 21,046 appointments via telehealth rather than in a VA
clinic, including beneficiary travel reimbursement ($143,357); clinic
staff, space, and equipment cost savings ($6,888,345).\49\ The
beneficiary travel reimbursement cost saving does not include the
opportunity cost of the time required to travel to and from
appointments at a clinic. DEA estimates this cost savings to be
$492,476 annually.\50\ DEA used these cost savings estimates to
calculate the impact if 0-100% of those visits were conducted in the
veteran's home, resulting in a cost savings of between $0 and
$7,524,178 ($143,357 + $6,888,345 + $492,476) per year. DEA also
considered whether or not there would be an increase in the number of
patients that would be treated by VA practitioners pursuant to this
proposed rule. As mentioned in the economic analysis accompanying the
VA's 2018 telemedicine preemption rule,\51\ when providers can use more
of their appointment slots for telehealth care, it expands the
accessibility of the provider's services without requiring additional
clinical resources.\52\ Telehealth visits are used in place of in-
person visits but do not, in general, change the number of overall
visits, supply, or demand. Because DEA does not have a basis to
determine how many annual clinic appointments would transition to
telehealth appointments after promulgation of this proposed rule, DEA
chose to take the mid-point (the scenario in which 50% of the 21,046
clinic appointments become telehealth visits) of the cost savings
estimated previously. Therefore, the total annual estimated cost
savings is $3,762,089.
---------------------------------------------------------------------------
\48\ There is not a breakdown of whether the prescribed
scheduled III-V controlled substance was a narcotic or non-narcotic.
For the purposes of this analysis DEA assumes all 21,046 encounters
forms the basis for cost savings.
\49\ VA's Allocation Resource Center and Revenue Operations
Business Information Office calculated these figures on behalf of
DEA.
\50\ DEA used hourly median wage data for All Occupations
($22.00) to represent the hourly opportunity cost of travel time for
all patients. Bureau of Labor Statistics, May 2021 National
Occupational Employment and Wage Estimates, https://www.bls.gov/oes/current/oes_nat.htm (last accessed January 7, 2023). Loaded for
benefits, the hourly opportunity cost is $31.20 ($22.00 x 1.418).
Bureau of Labor Statistics, Employer Costs for Employee
Compensation--September 2022, https://www.bls.gov/news.release/pdf/ecec.pdf (last accessed January 7, 2023). Next, DEA estimated the
miles travelled per appointment by first dividing the VA-provided
travel reimbursement cost of $143,357 by the number of appointments
(21,046), which results in a per-appointment travel reimbursement
rate of $6.81. To convert the VA's per-appointment reimbursement
rate into miles driven per appointment, $6.81 is then divided by the
IRS medical mileage rate of $0.18 (https://www.irs.gov/newsroom/standard-mileage-rates-for-2018-up-from-rates-for-2017), resulting
in 37.84 miles. DEA conservatively assumes that it would take the
average patient 45 minutes (0.75 hours) to travel 37.84 miles,
round-trip. Multiplying the per-hour opportunity cost of $31.20 by
0.75 results in an opportunity cost of $23.40 per appointment. This
results in a total opportunity cost savings of $492,476 ($23.40 x
21,046) for patients.
\51\ 83 FR 21897 (May 11, 2018).
\52\ Department of Veterans Affairs, Impact Analysis for RIN
2900-AQ06 (2018), https://www.regulations.gov/document?D=VA-2017-VHA-0021-0083.
---------------------------------------------------------------------------
2. Transfers for VA Patients
Transfers borne by VA patients in the form of treatment co-pays are
expected to be reduced. VA stated that patient co-pays would be reduced
by $23,255 if the 21,046 appointments were conducted via telehealth
rather than in VA clinics. Because DEA does not have a basis to
determine how many annual clinic appointments would transition to
telehealth appointments after promulgation of this proposed rule, DEA
chose to take the mid-point (the scenario in which 50% of the 21,046
clinic appointments become telehealth visits), which results in a
reduction of transfers from VA patients of $11,628.
3. Benefits of Increased Access to Telemedicine
Telemedicine has the potential to help address accessibility issues
and improve access to care, including specialty care, for patients in
remote and other underserved areas. More than 75 percent of all
counties in the U.S. are classified as mental health shortage areas,
and 50 percent do not have any mental health professionals.\53\ The
need to travel long distances to receive treatment is a common barrier
to accessibility facing individuals in rural areas without reliable
transportation options.\54\ As of December 2018, there were 5,124
designated Mental Health--Health Professional Shortage Areas covering a
total population of 115,383,074 people.\55\ The greater range of
telemedicine practice that would be possible under this proposed rule
would allow practitioners to reach a greater number of patients,
improving health care outcomes and reducing costs for patients
throughout the country.
---------------------------------------------------------------------------
\53\ Substance Abuse and Mental Health Services Administration,
Rural Behavioral Health: Telehealth Challenges and Opportunities, at
4 (2016), https://store.samhsa.gov/system/files/sma16-4989.pdf.
\54\ Id.
\55\ Health Resources and Services Administration, Designated
Health Professional Shortage Area Statistics, First Quarter of FY
2019 Designated HPSA Quarterly Summary (2019), https://ersrs.hrsa.gov/ReportServer?/HGDW_Reports/BCD_HPSA/BCD_HPSA_SCR50_Qtr_Smry_HTML&rc:Toolbar=false.
---------------------------------------------------------------------------
In addition to the benefits mentioned above, there are many
benefits specifically for VA patients. A 2018 survey conducted by the
VA indicated that about 14 percent of veterans with a need for mental
health services self-reported living more than an hour from
[[Page 12886]]
the nearest VA facility.\56\ Among all the VA users with a need for
services, 10 percent reported they live more than one hour away from
the nearest VA facility offering mental health services.\57\ According
to the survey, living a long distance from a VA facility with mental
health services significantly decreased the odds of using VA mental
health care over non-VA mental health care, suggesting that further
expanding telemedicine options to rural veterans may improve access for
those who see the distance to the nearest VA mental health facility as
a barrier to choosing the VA for their care.\58\ Moreover, rural
veterans with mental health conditions are known to use VA services at
a lower rate and to have a higher rate of unmet mental health needs
than veterans living in urban communities.\59\ Increasing access to
care through telemedicine has the potential to address these issues.
---------------------------------------------------------------------------
\56\ Department of Veterans Affairs, Z. Joan Wang et al., 2018
Survey of Veteran Enrollees' Health and Use of Health Care (2019),
https://www.va.gov/healthpolicyplanning/soe2018/2018enrolleedatafindingsreport_9january2019final508compliant.pdf.
\57\ Id.
\58\ Id.
\59\ Id.
---------------------------------------------------------------------------
4. Summary of Cost Savings and Transfers
In conclusion, DEA estimates that the annual cost savings of this
proposed rule is $3,762,089, while annual transfer payments to the
federal government are decreased by $11,628. It should be noted that
this estimate of cost savings assumes that the practitioners who engage
in telemedicine pursuant to 21 U.S.C. 802(54)(G) would adhere to the
requirements of the proposed rule designed to reduce the risk of
diversion. If such requirements were not followed, the risk of
diversion would increase, and any resulting increase in diversion would
drive up the societal costs associated with the misuse of controlled
substances.
C. Summary of Economic Impact
As described above, DEA estimates the total annual cost savings of
this proposed rule is $3,762,089. Additionally, transfers are estimated
to decrease by $11,628 annually.
Executive Order 12988, Civil Justice Reform
The proposed regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice
Reform, to eliminate ambiguity, minimize litigation, establish clear
legal standards, and reduce burden.
Executive Order 13132, Federalism
This proposed rulemaking does not have federalism implications
warranting the application of E.O. 13132. The proposed 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 proposed 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 proposed rule and
by approving it certifies that it would not have a significant economic
impact on a substantial number of small entities.
In accordance with the RFA, DEA evaluated the impact of this
proposed rule on small entities. The proposed rule describes the
circumstances under which, pursuant to 21 U.S.C. 802(54)(G), a
practitioner may prescribe controlled substances to patients whom the
practitioner has not evaluated in person.
A significant number of practitioners, physicians and MLPs, work in
offices and institutions that meet the RFA's definition of small
entities. To estimate the number of affected entities, DEA first
determined the North American Industry Classification System
(``NAICS'') codes that most closely represent businesses that employ
practitioners that may engage in telemedicine pursuant to this
regulation. Then, DEA researched economic data for those codes. The
source of the economic data is the Small Business Administration
(``SBA''), Office of Advocacy, and is based on data provided by the
U.S. Census Bureau, Statistics of U.S. Businesses (``SUSB'').\60\ The
following business NAICS codes are estimated to represent businesses
that employ the affected practitioners:
---------------------------------------------------------------------------
\60\ SUSB's employer data contain the number of firms, number of
establishments, employment, and annual payroll for employment size
of firm categories by location and industry. A ``firm'' is defined
as an aggregation of all establishments owned by a parent company
(within a geographic location and/or industry) with some annual
payroll. Table of size standards, effective December 19, 2022.
https://www.sba.gov/document/support-table-size-standards (last
visited January 7, 2023). SUSB, 2017 SUSB Annual Data Tables by
Establishment Industry, Data by Enterprise Receipts Size. https://www.census.gov/data/tables/2017/econ/susb/2017-susb-annual.html. The
data table is available at https://www2.census.gov/programs-surveys/susb/tables/2017/us_6digitnaics_rcptsize_2017.xlsx (last visited
January 7, 2023).
621112--Offices of Physicians, Mental Health Specialists
621420--Outpatient Mental Health and Substance Abuse Centers
622210--Psychiatric and Substance Abuse Hospitals
SUSB data contains the number of firms by size ranges for each of
the NAICS codes. For the purposes of this analysis, the term ``firm''
as defined in the SUSB is used interchangeably with ``entity'' as
defined in the RFA.
To estimate the number of affected entities that are small
entities, DEA compared the SUSB data for the number of firms in various
firm size ranges with SBA size standards for each of the representative
NAICS codes. The SBA size standard is the firm size based on the number
of employees or annual receipts depending on industry. The SBA size
standards for NAICS codes 621112, 621420, and 622210 are annual
receipts of $13.5 million, $19 million, and $47 million, respectively.
The firms in each size range below the SBA size standard are small
firms. The number of firms below the SBA size standard was added to
determine the total number of small firms in each NAICS code. DEA
estimates that a total of 17,480 entities are affected by this proposed
rule, of which 16,453 (94.1 percent) are small entities. The analysis
is summarized in table 1 below.
[[Page 12887]]
Table 1--Number of Affected Entities and Small Entities
----------------------------------------------------------------------------------------------------------------
Number of SBA size Number of
NAICS Code firms standard ($) small firms
----------------------------------------------------------------------------------------------------------------
621112--Offices of Physicians, Mental Health Specialists........ 10,561 13,500,000 10,400
621420--Outpatient Mental Health and Substance Abuse Centers.... 6,523 19,000,000 5,849
622210--Psychiatric and Substance Abuse Hospitals............... 396 47,000,000 204
-----------------------------------------------
Total....................................................... 17,480 .............. 16,453
Percent of Total............................................ .............. .............. 94.1
----------------------------------------------------------------------------------------------------------------
While this proposed rule may affect a substantial number of small
entities in the affected industries, as discussed in the E.O. 12866
section above, DEA estimates that the cost of this rule is minimal for
all affected entities, including small entities. Therefore, DEA
concludes the proposed rule would not have a significant economic
impact on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
The estimated annual impact of this proposed rule is minimal. Thus,
DEA has determined in accordance with the Unfunded Mandates Reform Act
of 1995 (``UMRA'') (2 U.S.C. 1501 et seq.) that this action would not
result in any federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted for inflation) in any
one year. Therefore, neither a Small Government Agency Plan nor any
other action is required under provisions of UMRA.
Paperwork Reduction Act of 1995
This proposed rule would impose a new collection of information
under the Paperwork Reduction Act (``PRA''), 44 U.S.C 3501-3521. DEA
has identified the following collection(s) of information related to
this proposed rule. The collections of information contained in the
proposed rule, and identified as such, have been submitted to OMB for
review under section 3507(d). An agency may not conduct or sponsor, and
a person is not required to respond to a collection of information,
unless it displays a valid OMB control number. Copies of existing
information collections approved by OMB may be obtained at https://www.reginfo.gov/public/do/PRAMain.
A. Collections of Information Associated With the Proposed Rule
1. Title: Reporting Requirements for Practitioners Conducting
Telemedicine.
OMB control number: 1117-NEW.
Form numbers: N/A.
DEA is proposing this rule to describe the circumstances under
which, pursuant to 21 U.S.C. 802(54)(G), a practitioner may prescribe
controlled substances to patients whom the practitioner has not
evaluated in person.
DEA estimates the following number of respondents and burden
associated with this collection of information:
Number of respondents: 31,451.
Frequency of response: 12 per respondent per year.
Number of responses: 377,412.
Burden per response: 0.25 hours (rounded).
Total annual hour burden: 94,353.
B. Request for Comments Regarding the Proposed Collections of
Information
Written comments and suggestions from the public and affected
entities concerning the proposed collections of information are
encouraged. DEA solicits comment on the following issues:
Whether the proposed collection of information is
necessary for the proper performance of the functions of DEA, including
whether the information shall have practical utility.
The accuracy of DEA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used.
Recommendations to enhance the quality, utility, and
clarity of the information to be collected.
Recommendations to minimize the burden of the collection
of information on those who are to respond, including through the use
of automated collection techniques or other forms of information
technology.
All comments concerning collections of information under the
Paperwork Reduction Act must be submitted to the Office of Information
and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ,
Washington, DC 20503. Please state that your comments refer to RIN
1117-AB40/Docket No. DEA-407. All comments must be submitted to OMB on
or before March 31, 2023. The final rule will respond to any OMB or
public comments on the information collection requirements contained in
this proposed rule.
If you need a copy of the proposed information collection
instrument(s) with instructions or additional information, please
contact the Regulatory Drafting and Policy Support Section (DPW),
Diversion Control Division, Drug Enforcement Administration; Mailing
Address: 8701 Morrissette Drive, Springfield, Virginia 22152;
Telephone: (571) 362-3261.
List of Subjects
21 CFR Part 1300
Chemicals, Drug traffic control.
21 CFR Part 1304
Drug traffic control, Reporting and recordkeeping requirements.
21 CFR Part 1306
Administrative practice and procedure, Drug traffic control,
Prescription drugs, Reporting and recordkeeping requirements.
For the reasons set out above, the Drug Enforcement Administration
proposes to amend 21 CFR parts 1300, 1304, and 1306 as follows:
PART 1300--DEFINITIONS
0
1. The authority citation for part 1300 continues to read as follows:
Authority: 21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).
0
2. Amend Sec. 1300.04 by:
0
a. Revising the introductory text of paragraph (i).
0
b. Removing and reserving paragraph (j).
0
c. Redesignating paragraphs (k) and (l), as paragraphs (l) and (p).
0
d. Adding paragraphs (k), (m), (n), and (o).
The revisions and additions read as follows:
Sec. 1300.04 Definitions relating to the dispensing of controlled
substances by means of the internet.
* * * * *
(i) The term practice of telemedicine means the practice of
medicine in accordance with applicable Federal and State laws by a
practitioner (other than a pharmacist) who is at a location remote from
the patient and is
[[Page 12888]]
communicating with the patient, or health care professional who is
treating the patient, using an interactive telecommunications system
referred to in 42 CFR 410.78(a)(3), which practice falls within a
category listed in paragraphs (i)(1) through (7) of this section:
* * * * *
(j) [Reserved]
(k) A qualifying telemedicine referral means a referral to a
practitioner that is predicated on a medical relationship that exists
between a referring practitioner and a patient where the referring
practitioner has conducted at least one medical evaluation in the
physical presence of the patient, without regard to whether portions of
the evaluation are conducted by other practitioners, and has made the
referral for a legitimate medical purpose in the ordinary course of
their professional practice. A qualifying telemedicine referral must
note the name and National Provider Identifier of the practitioner to
whom the patient is being referred.
* * * * *
(m) The term telemedicine encounter means a communication between a
practitioner and a patient using an interactive telecommunications
system referred to in 42 CFR 410.78(a)(3).
(n) The term telemedicine prescription means a prescription issued
pursuant to Sec. 1306.31 by a physician, or a ``mid-level
practitioner'' as defined in Sec. 1300.01(b), engaging in the practice
of telemedicine as defined in Sec. 1300.04(j).
(o) An individual practitioner and a patient have a telemedicine
relationship established during the COVID-19 public health emergency
if:
(1) The practitioner has not conducted an in-person medical
evaluation of the patient;
(2) The practitioner has prescribed one or more controlled
substances based on telemedicine encounters during 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 and pursuant to the designation pursuant to that public health
emergency on March 16, 2020, by the Secretary of Health and Human
Services, with concurrence of the Acting DEA Administrator, that the
telemedicine allowance under section 802(54)(D) applies to all schedule
II-V controlled substances in all areas of the United States; and
(3) No more than 180 days have elapsed since [EFFECTIVE DATE OF
RULE] or the end 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, whichever is later.
* * * * *
PART 1304--RECORDS AND REPORTS OF REGISTRANTS
0
9. The authority citation for part 1304 continues to read as follows:
Authority: 21 U.S.C. 821, 827, 871(b), 958(e)-(g), and 965,
unless otherwise noted.
0
10. In Sec. 1304.03, revise paragraph (c) and add new paragraphs (i),
(j), and (k), to read as follows:
Sec. 1304.03 Persons required to keep records and file reports.
* * * * *
(c) Except as provided in paragraph (i) of this section and Sec.
1304.06, a registered individual practitioner is not required to keep
records of controlled substances in Schedules II, III, IV, and V that
are prescribed in the lawful course of professional practice, unless
such substances are prescribed in the course of maintenance or
detoxification treatment of an individual.
* * * * *
(i) An individual practitioner shall maintain, for each
telemedicine prescription they issue, records indicating the date the
prescription was issued; the full name and address of the patient; and
the drug name, strength, dosage form, quantity prescribed, and
directions for use; the address at which the practitioner, and the city
and State in which the patient, are located during the telemedicine
encounter; if issued a qualifying telemedicine referral, the name, and
National Provider Identifier of the referring practitioner, a copy of
the referral and any communications shared pursuant to Sec.
1306.31(d)(3); and all efforts to comply to access the PDMP system
(and, if employed by the Department of Veterans Affairs, Department of
Veterans Affairs internal prescription database).
(j) An individual practitioner shall maintain copies of all
qualifying telemedicine referrals, as defined in Sec. 1300.04(k), that
they issue.
(k)(1) An individual practitioner who participates in a medical
evaluation conducted pursuant to Sec. 1306.31(d)(2) as the prescribing
practitioner shall maintain, for each such medical evaluation, the data
and time of the evaluation; the National Provider Identifier (NPI) of
the DEA-registered healthcare worker physically present with the
patient; the address at which the prescribing practitioner is located
during the telemedicine encounter; and the address at which the DEA-
registered healthcare worker is physically present with the patient
during the medical evaluation.
(2) An individual practitioner who participates in a medical
evaluation conducted pursuant to Sec. 1306.31(d)(2) as the DEA-
registered healthcare worker physically present with the patient shall
maintain, for each such medical evaluation, the data and time of the
evaluation; the address at which the prescribing practitioner is
located during the telemedicine encounter; the National Provider
Identifier (NPI) of the prescribing practitioner; and the address at
which the DEA-registered healthcare worker is physically present with
the patient during the medical evaluation.
* * * * *
0
11. In Sec. 1304.04, add paragraph (i) to read as follows:
Sec. 1304.04 Maintenance of records and inventories.
* * * * *
(i)(1) An individual practitioner shall maintain all records
related to telemedicine prescriptions and qualifying telemedicine
referrals required by this part at the registered location on the
certificate of registration issued pursuant to section 303(f) of the
Act (21 U.S.C. 823(g)). If the practitioner holds more than one
registration issued pursuant to section 303(f) of the Act (21 U.S.C.
823(g)), the practitioner shall designate the location on one such
certificate of registration at which to maintain all such records. If
the individual practitioner is exempt from registration to dispense
controlled substances pursuant to 21 U.S.C. 822(d), the practitioner
shall maintain all records related to telemedicine prescriptions and
qualifying telemedicine referrals required by this part at the location
where they maintain other records related to controlled substances.
(2) If a prescribing practitioner conducts an evaluation during
which the patient is treated by, and in the physical presence of, a
DEA-registered practitioner (other than the prescribing practitioner)
pursuant to section 1306.31(d)(2), both the prescribing practitioner
and the DEA-registered practitioner shall maintain records required by
this part at the registered location on the practitioners' respective
certificates of registration issued pursuant to section 303(f) of the
Act (21 U.S.C. 823(g)).
* * * * *
PART 1306--PRESCRIPTIONS
0
12. The authority citation for part 1306 continues to read as follows:
[[Page 12889]]
Authority: 21 U.S.C. 821, 829, 871(b), unless otherwise noted.
0
13. Amend Sec. 1306.05 by adding paragraph (i), to read as follows.
Sec. 1306.05 Manner of issuance of prescriptions.
* * * * *
(i) In addition to the requirements of this section, the
practitioner shall note on the face of any telemedicine prescription,
or within the prescription order if prescribed electronically, that the
prescription has been issued based on a telemedicine encounter.
0
14. After Sec. 1306.27, add an undesignated center header and Sec.
1306.31 to read as follows:
* * * * *
Other Provisions
Sec. 1306.31 Circumstances under which the practice of telemedicine
may be conducted pursuant to 21 U.S.C. 802(54)(G).
(a) An individual practitioner may issue telemedicine prescriptions
if all of the following conditions are met:
(1) The telemedicine prescription is pursuant to a telemedicine
encounter and is issued for a legitimate medical purpose by a
practitioner acting in the usual course of professional practice.
(2) At the time of the telemedicine encounter that gives rise to
the issuance of the telemedicine prescription, the practitioner is
located in a State, Territory, or possession of the United States; the
District of Columbia; or the Commonwealth of Puerto Rico.
(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).
(4) The prescription includes the information required by Sec.
1306.05.
(b) In addition to the conditions outlined in paragraph (a),
practitioners are also subject to the limitations in paragraphs (c),
(d), (e), and (f) of this section when prescribing controlled
substances pursuant to this section.
(c) Characteristics of telemedicine prescriptions:
(1) A telemedicine prescription may only be for a:
(i) A schedule III, IV, or V non-narcotic controlled substance; or
(ii) Any controlled substance that the practitioner is otherwise
authorized to prescribe, provided that one or more of the following
criteria are met:
(A) The prescribing practitioner has received a qualifying
telemedicine referral as defined in Sec. 1300.04(k) for that patient
from a referring practitioner who has conducted a medical evaluation as
described in paragraph (d)(3) of this section;
(B) The prescribing practitioner is employed by the Department of
Veterans Affairs and the prescription is issued for a patient of the
Department of Veterans Affairs health system who has received an in-
person medical evaluation from a practitioner who, at the time of the
examination was employed by the Department of Veterans Affairs; or
(C) The prescribing practitioner has a telemedicine relationship
established during the COVID-19 public health emergency with the
patient, as defined in Sec. 1300.04(o).
(2) The prescribing practitioner may issue multiple prescriptions
for the patient, provided, however, that the prescriptions do not
authorize the dispensing of more than a total quantity of a 30 day
supply of the controlled substance. This 30-day limitation shall not
apply to prescriptions issued by a practitioner who has a telemedicine
relationship established during the COVID-19 public health emergency
with the patient, as defined in Sec. 1300.04(o), or to a practitioner
employed by the Department of Veterans Affairs when prescribing to a
patient of the Department of Veterans Affairs health system who has
received an in-person medical evaluation from a practitioner who, at
the time of the examination, was employed by the Department of Veterans
Affairs. The prescribing practitioner may prescribe a supply in
addition to the 30 day supply if a medical evaluation is conducted
pursuant to paragraph (d)(1), (2), or (3) of this section.
(d) Such a medical evaluation for the purposes of this section may
be one of the following:
(1) An evaluation during which the patient is treated by, and in
the physical presence of, the prescribing practitioner;
(2) An evaluation during which:
(i) The patient is treated by, and in the physical presence of, a
DEA-registered practitioner (other than the prescribing practitioner);
(ii) This practitioner in the physical presence of the patient is
acting in the usual course of professional practice;
(iii) The evaluation is conducted in accordance with applicable
State law; and
(iv) The remote prescribing practitioner, the patient, and the DEA-
registered practitioner on site with the patient participate in a real-
time, audio-video conference in which both the practitioners and the
patient communicate simultaneously.
(3) An evaluation during which the patient is treated by, and in
the physical presence of, an individual DEA registered practitioner, or
individual practitioner exempt from registration under 21 U.S.C.
822(d), who:
(i) Issued a written qualifying telemedicine referral as defined in
Sec. 1300.04(k) for the patient to the prescribing practitioner;
(ii) Communicated the results of the evaluation by sharing the
relevant information in the medical record which includes, at a
minimum, the diagnosis, evaluation, and treatment of the patient prior
to the prescribing practitioner issuing the prescription; and
(iii) Has issued the written referral based on the diagnosis,
evaluation, or treatment that occurred as a result of the medical
evaluation.
(e)(1) Prior to issuing the prescription, the practitioner,
including a practitioner employed by the Department of Veterans
Affairs, must review and consider the prescription drug monitoring
program in the State where the patient is located (if the State has
such a program) for data regarding any controlled substance
prescriptions issued to the patient in the last year, or, if less than
one year of data is available, in the entire available period. The
practitioner, if employed by the Department of Veterans Affairs, must
also review the Department of Veterans Affairs internal prescription
database for data regarding any controlled substance prescriptions
issued to the patient in the last year, or, if less than a year of data
is available, in the entire available period.
(2) If the practitioner is unable to obtain the PDMP (or, if
employed by the Department of Veterans Affairs, the Department of
Veterans Affairs internal prescription database) data due to the PDMP
(or Department of Veterans Affairs internal prescription database)
system being non-operational or otherwise inaccessible as a result of a
temporary technological or electrical failure, then:
(i) The practitioner may issue the prescription for no more than a
7-day supply;
(ii) The practitioner must obtain the PDMP (and, if employed by the
Department of Veterans Affairs, Department of Veterans Affairs internal
prescription database) data and conduct the review described in
paragraph (e)(1) of this section within 7 days of the telemedicine
encounter; and
(iii) The practitioner must record the attempts to obtain the PDMP
and (if
[[Page 12890]]
applicable) the Department of Veterans Affairs internal prescription
database data. If the practitioner fails to obtain the PDMP (or, if
employed by the Department of Veterans Affairs, Department of Veterans
Affairs internal prescription database) data as described in paragraph
(e)(1) of this section, the dates and times that the practitioner
attempted to gain access, the reason why the practitioner was unable to
gain access, and any follow-up attempts made to gain access to the
system.
(3) Upon completing the review described in paragraph (e)(1) of
this section, the practitioner may issue prescriptions authorizing the
dispensing of no more than a 30-day supply across all such
prescriptions, unless otherwise exempted from the 30-day supply
limitation.
(f) If the prescribing practitioner does not conduct a medical
evaluation meeting the requirements of clause (d)(1), (2), or (3) of
this section within a period of 30 calendar days of first issuing the
prescription, the practitioner may not issue any subsequent
telemedicine prescriptions to that patient until such a medical
evaluation has been conducted. This restriction shall not apply to a
practitioner who has a telemedicine relationship established during the
COVID-19 public health emergency with the patient, as defined in Sec.
1300.04(o), or to a practitioner employed by the Department of Veterans
Affairs when prescribing to a patient of the Department of Veterans
Affairs health system who has received an in-person medical evaluation
from a practitioner who, at the time of the examination, was employed
by the Department of Veterans Affairs.
(g) Except as provided in this section, telemedicine prescriptions
must be consistent with all other requirements of this part.
Signing Authority
This document of the Drug Enforcement Administration was signed on
February 24, 2023, by Administrator Anne Milgram. That document with
the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
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.
[FR Doc. 2023-04248 Filed 2-27-23; 2:30 pm]
BILLING CODE 4410-09-P