Proposed Rule2025-01099
Special Registrations for Telemedicine and Limited State Telemedicine Registrations
Primary source
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Published
January 17, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the "Ryan Haight Act") generally requires an in-person medical evaluation prior to the issuance of a prescription of controlled substances but provides an exception to this in-person medical evaluation requirement where the practitioner is engaged in the "practice of telemedicine" within the meaning of the Ryan Haight Act. These proposed regulatory changes would establish a Special Registration framework and authorize three types of Special Registration. This proposed rulemaking also provides for heightened prescription, recordkeeping, and reporting requirements. DEA believes such changes are necessary to effectively expand patient access to controlled substance medications via telemedicine while mitigating the risks of diversion associated with such expansion. A summary of this rule may be found at https://www.regulations.gov/docket/DEA-2023-0029.
Full Text
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<title>Federal Register, Volume 90 Issue 11 (Friday, January 17, 2025)</title>
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[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Proposed Rules]
[Pages 6541-6598]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-01099]
Federal Register / Vol. 90 , No. 11 / Friday, January 17, 2025 /
Proposed Rules
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1301, 1304, and 1306
[Docket No. DEA-407]
RIN 1117-AB40
Special Registrations for Telemedicine and Limited State
Telemedicine Registrations
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Ryan Haight Online Pharmacy Consumer Protection Act of
2008 (the ``Ryan Haight Act'') generally requires an in-person medical
evaluation prior to the issuance of a prescription of controlled
substances but provides an exception to this in-person medical
evaluation requirement where the practitioner is engaged in the
``practice of telemedicine'' within the meaning of the Ryan Haight Act.
These proposed regulatory changes would establish a Special
Registration framework and authorize three types of Special
Registration. This proposed rulemaking also provides for heightened
prescription, recordkeeping, and reporting requirements. DEA believes
such changes are necessary to effectively expand patient access to
controlled substance medications via telemedicine while mitigating the
risks of diversion associated with such expansion. A summary of this
rule may be found at <a href="https://www.regulations.gov/docket/DEA-2023-0029">https://www.regulations.gov/docket/DEA-2023-0029</a>.
DATES: Electronic comments must be submitted, and written comments must
be postmarked, on or before March 18, 2025. 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 (OMB) on or before March 18, 2025.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-407'' on all correspondence, including any
attachments.
<bullet> Electronic comments: DEA encourages that all comments be
submitted electronically through the Federal eRulemaking Portal, which
provides the ability to type comments directly into the comment field
on the web page or to attach a file containing comments. Please go to
<a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 generated by
<a href="http://www.regulations.gov">http://www.regulations.gov</a>. Please be aware that submitted comments are
not instantaneously available for public view on <a href="http://www.regulations.gov">http://www.regulations.gov</a>. If you have received a Comment Tracking Number,
your comment has been successfully submitted, and there is no need to
resubmit the same comment.
<bullet> Paper comments: Paper comments that duplicate the
electronic submission are discouraged. Should you wish to mail a paper
comment in lieu of submitting a comment electronically, it should be
sent via regular or express mail to: Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152. Hand-delivered comments will not be
accepted.
<bullet> 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, OMB,
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: Heather E. Achbach, Regulatory
Drafting and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 776-3882.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received, including attachments and
other supporting materials, in response to this docket are considered
part of the public record. The Drug Enforcement Administration (DEA)
will make all comments available for public inspection online at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. The Freedom of Information Act applies to all
comments received. Confidential information or personal identifying
information (PII), 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
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.
Overview
I. Executive Summary
II. Legal Authority and Background
III. Need for Further Rulemaking: Special Registration
IV. Section-by-Section Discussion of Proposed Rule
A. Registration Requirements Under 21 CFR Part 1301
1. Three Types of Special Registration and Eligibility of
Clinician Practitioners and Platform Practitioners
a. Telemedicine Prescribing Registration Eligibility
b. Advanced Telemedicine Prescribing Registration Eligibility
c. Telemedicine Platform Registration Eligibility
2. Ancillary Registrations: State Telemedicine Registrations
3. Special Registration Application Process
a. Special Registration Application, Cycles, and Fees
b. Supplemental Special Registration Application Requirements
(Form 224S)
c. Notification of Changes to Application Information and Other
Modifications (Form 224S-M)
4. Special Registration Actions
a. Approvals and Denials of Special Registration Applications
b. Suspension and Revocations of Special Registrations
B. Special Registration Prescriptions Issued by Clinician
Special Registrants under 21 CFR part 1306
1. Manner of Issuance of Special Registration Prescriptions
2. Additional Elements on a Special Registration Prescription
C. Recordkeeping and Reporting Under 21 CFR Part 1304
1. Patient Verification Photographic Records
2. Special Registration Telemedicine Encounter Records
3. Credentials Verification and Conduct-Related Documentation
Records
4. Centralized Recordkeeping at the Special Registered Location
[[Page 6542]]
5. Pharmacy and Special Registrant Reporting of Special
Registration Prescription Data
6. Individual Special Registrant Reporting of Aggregated Special
Registration Prescription Data
D. Regulatory Definitions Under 21 CFR Part 1300
E. Request for Comments
V. Regulatory Analyses
I. Executive Summary
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008
(the ``Ryan Haight Act''), amended the Controlled Substances Act (CSA)
by, among other things, requiring all prescription drugs which are
dispensed by means of the internet \1\ be issued as a ``valid
prescription.'' \2\ Generally, a valid prescription requires, at a
minimum, at least one ``in-person medical evaluation,'' \3\ which is
issued for a legitimate medical purpose in the usual course of
professional practice.\4\ The Ryan Haight Act does, however, provide an
exception to this in-person medical evaluation requirement, when the
practitioner is ``engaged in the practice of telemedicine.'' \5\
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\1\ Italicized terms indicate that it is a proposed term defined
by the NPRM or a term currently defined in the CSA or DEA's
regulations.
\2\ 21 U.S.C. 829(e)(1).
\3\ 21 U.S.C. 829(e)(2)(B)(i).
\4\ 21 U.S.C. 829(e)(2)(A)(i).
\5\ 21 U.S.C. 829(e)(3)(A).
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The Ryan Haight Act provides seven (7) distinct categories of the
practice of telemedicine in which a prescribing practitioner need not
satisfy the Ryan Haight Act's in-person medical evaluation requirement,
yet nonetheless may be able to prescribe a controlled substance for a
legitimate medical purpose in the usual course of professional
practice.\6\ In these circumstances, provided certain safeguards are in
place to ensure that the practitioner who is engaged in the practice of
telemedicine is able to conduct a bona fide medical evaluation of the
patient at the remote location, and is otherwise acting in the usual
course of professional practice, the Ryan Haight Act contemplates that
the practitioner will be permitted to prescribe controlled substances
by means of the internet despite not having conducted an in-person
medical evaluation.
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\6\ 21 U.S.C. 802(54).
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Thus far, DEA has permitted, or promulgated regulations to permit,
the practice of telemedicine pursuant to two of the seven categories of
telemedicine authorized under the Ryan Haight Act. In March 2020, in
response to the COVID-19 Public Health Emergency (``COVID-19 PHE'')
declared by the Secretary (the ``Secretary'') of the Department of
Health and Human Services (HHS) on January 31, 2020, pursuant to the
authority under section 319 of the Public Health Service Act (42 U.S.C.
247), DEA used its authority under 21 U.S.C. 802(54)(D) to grant
temporary exceptions to the Ryan Haight Act and its implementing
regulations, allowing authorized practitioners to generally prescribe
controlled substances in Schedules II-V through telemedicine.
Three years later, in March 2023, DEA, in concert with HHS,
promulgated two notices of proposed rulemakings (NPRMs) (the ``General
Telemedicine NPRM,'' and ``Buprenorphine NPRM'') pursuant to 21 U.S.C.
802(54)(G), which collectively proposed to expand patient access to
prescriptions via telemedicine relative to the pre-COVID-19 PHE
landscape. On May 10, 2023, to prevent a lapse of care with the
expiration of the COVID-19 PHE, DEA, jointly with HHS, promulgated a
rule (the ``First Temporary Rule'') pursuant to 21 U.S.C.802(54)(G) to
extend the temporary exceptions originally authorized under the COVID-
19 PHE through November 11, 2023.
On September 12 and 13, 2023, DEA hosted live, in-person
Telemedicine Listening Sessions to receive additional input concerning
the practice of telemedicine with regards to controlled substances and
potential safeguards that could effectively prevent and detect
diversion of controlled substances prescribed via telemedicine. DEA
invited the public to express their views concerning the advisability
of permitting telemedicine prescribing of certain controlled substances
without any in-person medical evaluation at all, the availability and
types of data that would be useful in detecting diversion of controlled
substances via telemedicine, and specific additional safeguards that
could be placed around the prescribing of Schedule II controlled
substances via telemedicine.
On October 10, 2023, in light of the need to further evaluate the
best course of action given the comments received in response to the
March 2023 NPRMs and the presentations at the September 2023
Telemedicine Listening Sessions, DEA, jointly with HHS, issued a second
temporary rule (the ``Second Temporary Rule'') to further extend the
temporary exceptions originally authorized under the COVID-19 PHE
through December 31, 2024. On November 19, 2024, DEA and HHS issued a
third temporary rule (the ``Third Temporary Rule'') to again extend the
temporary exceptions originally authorized under the COVID-19 PHE
through December 31, 2025, to ensure a smooth transition for patients
and practitioners that have come to rely on the availability of
telemedicine for controlled substance prescriptions.
The Third Temporary Rule has also provided additional time for DEA
to promulgate the Special Registration regulations proposed in this
NPRM, and additional time for practitioners to come into compliance
with any new standards or safeguards eventually found within a final
rule establishing a Special Registration framework. DEA has determined
that the best course of action to ensure patient access to care, while
maintaining sufficient safeguards to prevent and detect diversion of
controlled substances, is to establish and maintain a regulatory scheme
including three separate Special Registrations pursuant to 21 U.S.C.
802(54)(E) and 21 U.S.C. 831(h).
These separate Special Registrations would allow more comprehensive
prescribing, including prescribing of Schedule II and narcotic and non-
narcotic controlled substances in limited circumstances, by properly
registered physicians and mid-level practitioners (hereinafter
collectively referred to as clinician practitioners), and dispensing by
online telemedicine platforms that constitute covered online
telemedicine platforms, in their capacity as platform practitioners,
who have proven to have a legitimate need for such Special
Registrations and where DEA has concluded that such registration is
consistent with the public interest. Once properly registered under the
Special Registration framework, clinician practitioners would be
considered clinician special registrants and covered online
telemedicine platforms, in their capacity as platform practitioners,
would be considered platform special registrants.
This NPRM introduces the three types of Special Registrations for
Telemedicine: (1) a Telemedicine Prescribing Registration, authorizing
qualified clinician practitioners to prescribe Schedule III-V
controlled substances via telemedicine, (2) an Advanced Telemedicine
Prescribing Registration, authorizing qualified, specialized clinician
practitioners (e.g., psychiatrists, hospice care physicians) to
prescribe Schedule II-V controlled substances via telemedicine, and (3)
a Telemedicine Platform Registration, authorizing covered online
telemedicine platforms, in their capacity as platform practitioners, to
dispense Schedule II-V controlled substances.\7\ To satisfy the
[[Page 6543]]
statutory requirements under 21 U.S.C. 831(h), DEA would also require
the special registrant to maintain a State Telemedicine Registration
for every state in which a patient is treated by the special
registrant, unless otherwise exempted. The State Telemedicine
Registration would be issued by DEA, not the states, and operate as an
ancillary credential, contingent on the Special Registration held by
the special registrant.
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\7\ The term ``institutional practitioner'' is currently defined
at 21 CFR 1300.01. Proposed changes to 21 CFR 1300.01 will
explicitly exclude ``covered online telemedicine platform'' to
clarify that such an entity is not an ``institutional
practitioner.''
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To streamline the Special Registration application process, the
NPRM would introduce a new registration application form, known as Form
224S. The three types of Special Registrations (Telemedicine
Prescribing Registration, Advanced Telemedicine Prescribing
Registration, and Telemedicine Platform Registration) and the State
Telemedicine Registration (one type for clinician special registrants
and one type for platform special registrants) would be on a three-year
cycle. The NPRM also proposes heightened prescription requirements
addressing the manner in which special registration prescriptions are
issued, as well as additional elements required to be on a special
registration prescription issued under a Special Registration.
Special registration prescriptions issued under the Special
Registration would be required to be prescribed through electronic
prescribing for controlled substances (EPCS), and after the special
registrant has verified the identity of the patient and carried out a
nationwide Prescription Drug Monitoring Program (PDMP) check of all 50
states and any U.S. district or territory that maintains its own PDMP
(referred to as the ``nationwide PDMP check''). The nationwide PDMP
check requirement, however, would have a delayed effective date of
three years. In the interim, for all Schedule II-V controlled
substances, clinician special registrants would be required to conduct
a PDMP check of: (1) the state/territory where the patient is located;
(2) the state/territory where the clinician special registrant is
located; and (3) any state/territory that has a PDMP reciprocity
agreement with the states/territories where the patient and clinician
special registrant are located.
Furthermore, special registration prescriptions would require the
inclusion of the Special Registration numbers of the clinician special
registrant and the platform special registrant (if a platform special
registrant facilitated the prescription), and the State Telemedicine
Registration numbers of the clinician special registrant and platform
special registrant (if a platform special registrant facilitated the
prescription). To ensure clarity and easy identification of the type of
registration, Special Registration numbers and State Telemedicine
Registration numbers would be formatted distinctly. This would allow
registrants and DEA to differentiate them from each other and from
conventional DEA registration numbers issued under 21 U.S.C. 823(g).
Additionally, pharmacies filling special registration prescriptions
would be able to easily verify these registration numbers to confirm
that the prescribing clinician practitioner is authorized to prescribe
controlled substances within a given Schedule via a Special
Registration, and that a platform practitioner, if one facilitated the
special registration prescription, is authorized to dispense controlled
substances under the Special Registration framework.
It is also important to note when the proposed regulations would
not apply. The Ryan Haight Act, and the telemedicine regulations
implementing it thereunder, apply only in limited circumstances,
impacting only a subset of practitioner-patient relationships: those
where the prescribing practitioner intends to prescribe controlled
substances, and has never conducted an in-person medical evaluation of
the patient prior to the issuance of the prescription. In other words,
the regulations implemented under the Ryan Haight Act would not be
applicable to practitioner-patient relationships in which there has
ever been a prior in-person medical evaluation of the patient by the
practitioner.
Moreover, the regulations proposed in this rule are further limited
to telemedicine practiced under a Special Registration,\8\ but would
not apply to the other forms of the practice of telemedicine authorized
under the Ryan Haight Act. The proposed regulations within this NPRM
would not apply to the practice of telemedicine authorized under 21
U.S.C. 802(54)(A)-(D), (F), and (G). Therefore, these proposed
regulations would not apply to the practice of telemedicine authorized
under the Expansion of Buprenorphine Treatment via Telemedicine
Encounter final rule (RIN 1117-AB78) or the Continuity of Care via
Telemedicine for Veterans Affairs Patients final rule (RIN 1117-AB88)
published elsewhere in this issue of the Federal Register. Under the
authority of 21 U.S.C. 802(54)(G), these final rules permit, in limited
circumstances, certain prescribing practitioners to issue prescriptions
for controlled substances by telemedicine, without having personally
performed an in-person medical evaluation or fulfilling the Special
Registration requirements as proposed within this rule. At this stage,
DEA remains committed to actively soliciting and considering feedback
from the public and revising the Special Registration regulations as
necessary and appropriate.\9\
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\8\ 21 U.S.C. 802(54)(E).
\9\ See Appendix A for Chart: Do I Need a Special Registration
for Telemedicine?
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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 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.\10\
The CSA further authorizes the Attorney General (and the Administrator
by delegation through 28 CFR part 0) 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.\11\
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\10\ ``Dispense'' in the context of this rulemaking means to
deliver a controlled substance to an ultimate user, which includes
the prescribing of a controlled substance. 21 U.S.C 802(10).
\11\ 21 U.S.C. 871(b), 958(f).
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The Ryan Haight Online Pharmacy Consumer Protection Act of 2008.
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. A central
feature of the Ryan Haight Act is the in-person medical evaluation
requirement. The in-person medical evaluation requirement is set forth
in 21 U.S.C. 829(e), which provides that ``[n]o controlled substance
that is a prescription drug as determined under the Federal Food, Drug,
and
[[Page 6544]]
Cosmetic Act may be . . . dispensed by means of the internet without a
valid prescription,'' \12\ and which defines ``valid prescription'' as
``a prescription that is issued for a legitimate medical purpose in the
usual course of professional practice by . . . a practitioner who has
conducted at least 1 in-person medical evaluation of the patient.''
\13\ Section 829(e), however, provides an exception to this in-person
medical evaluation requirement where the practitioner is ``engaged in
the practice of telemedicine.'' \14\
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\12\ 21 U.S.C. 829(e)(1).
\13\ Id. at 829(e)(2)(A)(i). Under the Ryan Haight Act, the
requirement of an in-person medical evaluation does not apply to a
``covering practitioner,'' id. 829(e)(2)(A)(ii), as defined by
829(e)(2)(C). A prescribing practitioner meeting this definition
need not conduct an in-person medical evaluation as a prerequisite
to prescribing a controlled substance to a given patient, provided
that the practitioner for whom the practitioner is covering has
provided an in-person medical evaluation of that patient and
provided further that this covering arrangement is taking place on
only a temporary basis. In addition, the covering practitioner--as
with all practitioners who prescribe controlled substances--remains
subject to the requirement that such prescriptions may be issued
only for a legitimate medical purpose in the usual course of
professional practice. Id.
\14\ Id. 829(e)(3)(A).
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Pursuant to 21 U.S.C. 802(54) the practice of telemedicine means
``the practice of medicine in accordance with applicable Federal and
state laws by a practitioner (other than a pharmacist) \15\ who is at a
location remote from the patient and is communicating with the patient,
or health care professional who is treating the patient, using a
telecommunications system \16\ referred to in section 1395m(m) of Title
42,'' and which also falls within one of seven distinct categories that
Congress determined were appropriate to allow for the prescribing of
controlled substances via telemedicine despite the practitioner never
having conducted an in-person medical evaluation of the patient.
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\15\ While this statutory definition of the practice of
telemedicine explicitly excludes pharmacists, such exclusion does
not apply to situations where a pharmacist is acting in their
capacity as a mid-level practitioner, authorized to dispense
controlled substances in accordance with their state licensure.
\16\ 42 U.S.C. 1395m(m) references, but does not define, such
telecommunications systems. The Center for Medicare and Medicaid
Services (CMS) promulgated regulations implementing these statutory
provisions and define the term interactive telecommunications
system. 42 CFR 410.78(a)(3) defines interactive telecommunications
system as ``. . . [the] multimedia communications equipment that
includes, at a minimum, audio and video equipment permitting two-
way, real-time interactive communication between the patient and
distant site physician or practitioner. 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'' (emphases added). Though
DEA's proposed regulatory definition for audio-video
telecommunications system largely aligns with CMS's definition of
interactive telecommunications system, DEA's proposed regulations
would not authorize the use of audio-only communication technology
for the diagnosis, evaluation, or treatment of mental health
disorders, subject to one exception for opioid use disorder
discussed in more depth later. These provisions reflect the
heightened risks associated with prescribing controlled substances
specifically.
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The seven distinct categories provided under the statutory
definition of the practice of telemedicine generally involve either
circumstances in which an in-person medical evaluation has been
rendered impracticable due to temporary emergencies, or circumstances
in which the prescribing practitioner might be unable to satisfy the
Ryan Haight Act's in-person medical evaluation requirement, yet
nonetheless has sufficient medical information to prescribe a
controlled substance for a legitimate medical purpose in the usual
course of professional practice. In these circumstances, provided
certain safeguards are in place to ensure that the practitioner who is
engaged in the practice of telemedicine is able to conduct a bona fide
medical evaluation of the patient at the remote location, and is
otherwise acting in the usual course of professional practice, the Ryan
Haight Act contemplates that the practitioner will be permitted to
prescribe controlled substances by means of the internet despite not
having conducted an in-person medical evaluation. The Ryan Haight Act
defines these categories through the definition of ``practice of
telemedicine,'' which is set forth in 21 U.S.C. 802(54).
As a general matter, those seven distinct categories include
telemedicine encounters where: (1) a patient is physically located at a
DEA-registered hospital or clinics, and the remote prescribing
practitioner is DEA-registered in the state in which the patient is
located; (2) a patient is being treated by a prescribing practitioner,
and in the physical presence of a DEA-registered practitioner in the
state in which the patient is located; (3) the prescribing practitioner
is an employee or contractor of the Indian Health Service (IHS), acting
within the scope of the practitioner's employment, who has been
designated an internet Eligible Controlled Substances Provider by HHS;
(4) it takes place during a public health emergency declared by HHS
under section 247d of title 42; (5) the practitioner has obtained a
Special Registration with DEA; \17\ (6) there is a medical emergency
that prevents the patient from being in the physical presence of an
employee or contractor of the Veterans Health Administration (VHA) and
one of its hospitals or clinics, and immediate intervention by the
practitioner using controlled substances is required to prevent injury
or death; and (7) any other circumstances that DEA and HHS have jointly
determined to be consistent with effective controls against diversion
and otherwise consistent with the public health and safety.\18\
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\17\ Congress enacted legislation in addition to the Ryan Haight
Act which required DEA to ``promulgate final regulations specifying
. . . the limited circumstances in which a special registration for
telemedicine may be issued.'' 21 U.S.C. 831(h)(2). In particular,
the SUPPORT for Patients and Communities Act (``SUPPORT Act''),
signed into law on October 24, 2018, mandated that, in consultation
with the Secretary [of Health and Human Services], the Attorney
General shall promulgate final regulations specifying--(A) the
limited circumstances in which a special registration for
telemedicine . . . may be issued; and (B) the procedure for
obtaining [a] special registration for telemedicine.'' Substance
Use-Disorder Prevention that Promotes Opioid Recovery and Treatment
for Patients and Communities Act (SUPPORT Act), Public Law 115-271,
3232, 132 Stat. 3894, 3950 (2018). The Attorney General has
delegated this authority to the Administrator of DEA. See 28 CFR
0.100. As required by the SUPPORT Act, DEA has consulted with
representatives of the Secretary of Health and Human Services
regarding the substance of this proposed rule.
\18\ 21 U.S.C. 802(54).
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As noted above, the Ryan Haight Act, and the telemedicine
regulations implementing it thereunder, apply only in limited
circumstances, impacting only a subset of practitioner-patient
relationships: where the prescribing practitioner wishes to prescribe
controlled substances and has never conducted an in-person medical
evaluation of the patient prior to the issuance of the prescription. In
other words, the regulations proposed in this rule would not be
applicable to practitioner-patient relationships in which there has
been a prior in-person medical evaluation of the patient by the
practitioner.
COVID-19 Public Health Emergency. In response to the COVID-19 PHE,
as declared by the Secretary on January 31, 2020, pursuant to the
authority under section 319 of the Public Health Service Act (42 U.S.C.
247), DEA granted temporary exceptions to the Ryan Haight Act and DEA's
implementing regulations under 21 U.S.C. 802(54)(D), one of the seven
distinct categories of telemedicine envisioned under the statutory
definition of the practice of telemedicine. In order to prevent lapses
in care, these exceptions allowed for the prescribing of controlled
substances via
[[Page 6545]]
telemedicine encounters even when the prescribing practitioner had not
conducted an in-person medical evaluation of the patient. These
telemedicine flexibilities authorized practitioners to prescribe
Schedule II-V controlled substances via audio-video telemedicine
encounters, including Schedule III-V opioid controlled substances
approved by the Food and Drug Administration (FDA) for maintenance and
withdrawal management treatment of opioid use disorder via audio-only
telemedicine encounters, provided that such prescriptions otherwise
comply with the recommendations outlined in DEA guidance documents, the
requirements outlined in DEA regulations, and applicable Federal and
State law. DEA granted those temporary exceptions to the Ryan Haight
Act and DEA's implementing regulations via two letters published in
March 2020:
<bullet> A March 25, 2020 ``Dear Registrant'' letter signed by
William T. McDermott, DEA's then-Assistant Administrator, Diversion
Control Division (the McDermott Letter); \19\ and
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\19\ William T. McDermott, DEA Dear Registrant letter, Drug
Enforcement Administration (March 25, 2020), <a href="https://www.deadiversion.usdoj.gov/GDP/">https://www.deadiversion.usdoj.gov/GDP/</a>(DEA-DC-
018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf.
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<bullet> A March 31, 2020 ``Dear Registrant'' letter signed by
Thomas W. Prevoznik, DEA's then-Deputy Assistant Administrator,
Diversion Control Division (the Prevoznik Letter).\20\
---------------------------------------------------------------------------
\20\ Thomas W. Prevoznik, DEA Dear Registrant letter, Drug
Enforcement Administration (March 31, 2020), <a href="https://www.deadiversion.usdoj.gov/GDP/">https://www.deadiversion.usdoj.gov/GDP/</a>(DEA-DC-
022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Fina
l)%20+Esign.pdf.
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Prior NPRMs and Temporary Rules; Telemedicine Listening Sessions.
On March 1, 2023, DEA, in concert with HHS and pursuant to 21 U.S.C.
802(54)(G), promulgated two NPRMs in the Federal Register, Telemedicine
Prescribing of Controlled Substances When the Practitioner and the
Patient Have Not Had a Prior In-Person Medical Evaluation (the
``General Telemedicine NPRM'') \21\ and Expansion of Induction of
Buprenorphine via Telemedicine Encounter (the ``Buprenorphine
NPRM''),\22\ which proposed to expand patient access to prescriptions
for controlled substances via telemedicine encounters relative to the
pre-COVID-19 PHE landscape. The purpose of the two proposed rules was
to make permanent some of the telemedicine flexibilities established
during the COVID-19 PHE in order to facilitate patient access to
controlled substance medications via telemedicine when consistent with
public health and safety, while maintaining effective controls against
diversion. The comment period for these two NPRMs closed on March 31,
2023. Those NPRMs generated a total of 38,369 public comments--35,454
comments on the General Telemedicine NPRM and 2,915 comments on the
Buprenorphine NPRM.
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\21\ 88 FR 12875 (Mar. 1, 2023).
\22\ 88 FR 12890 (Mar. 1, 2023).
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On May 10, 2023 DEA, jointly with HHS (with the Substance Abuse and
Mental Health Services Administration (SAMHSA) acting on behalf of
HHS), issued the First Temporary Rule pursuant to 21 U.S.C. 802(54)(G),
which extended the full set of telemedicine flexibilities regarding the
prescribing of controlled substances, as had been in place under the
COVID-19 PHE, through November 11, 2023.\23\ The First Temporary Rule
also provided a one-year grace period, through November 11, 2024, to
any practitioner-patient telemedicine relationships that had been or
would be established on or before November 11, 2023.
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\23\ Temporary Extension of COVID-19 Telemedicine Flexibilities
for Prescription of Controlled Medications, 88 FR 30037 (May 10,
2023).
---------------------------------------------------------------------------
On September 12 and 13, 2023, DEA hosted the live, in-person
Telemedicine Listening Sessions, to receive additional input concerning
the practice of telemedicine with regards to prescribing controlled
substances and potential safeguards that could effectively prevent and
detect diversion of controlled substances prescribed via telemedicine.
DEA invited the public to express their views concerning the
advisability of permitting telemedicine prescribing of certain
controlled substances without any in-person medical evaluation at all,
the availability and types of data that would be useful in detecting
diversion of controlled substances via telemedicine that are either
already reported or could be reported, and specific additional
safeguards that could be placed around the prescribing of Schedule II
controlled substances via telemedicine. Approximately 58 stakeholders,
including institutional practitioners and clinician practitioners,
pharmacists, trade associations, state agencies, and other public
interest groups, presented at the listening sessions.
On October 10, 2023, in light of the need to further evaluate the
best course of action given the comments received in response to the
March 2023 NPRMs and the presentations at the Telemedicine Listening
Sessions, DEA, jointly with HHS, issued the Second Temporary Rule, also
pursuant to 21 U.S.C. 802(54)(G), thereby extending the full set of
telemedicine flexibilities regarding prescription of controlled
substances as were in place during the COVID-19 PHE through December
31, 2024.\24\ The extension authorized all DEA-registered practitioners
to prescribe Schedule II-V controlled substances via telemedicine
through December 31, 2024, whether or not the patient and practitioner
established a telemedicine relationship on or before November 11, 2023.
In other words, the grace period provided in the First Temporary Rule
was effectively subsumed by this Second Temporary Rule, which continued
the extension of the current flexibilities for all practitioner-patient
relationships--not just those established on or before November 11,
2023--until the end of 2024. The purpose of the Second Temporary Rule,
like the one before it, was to ensure a smooth transition for patients
and practitioners that have come to rely on the availability of
telemedicine for controlled substance prescriptions, as well as to
allow adequate time for providers to come into compliance with any new
standards or safeguards that are promulgated as part of a final set of
telemedicine regulations.
---------------------------------------------------------------------------
\24\ Second Temporary Extension of COVID-19 Telemedicine
Flexibilities for Prescription of Controlled Medications, 88 FR
69879 (October 10, 2023).
---------------------------------------------------------------------------
Tribal Consultations. On June 13 and 27, 2024, the Office of Tribal
Justice, Department of Justice (OTJ) collaborated with DEA to host two
virtual DOJ Government-to-Government Tribal Consultations to seek input
from Tribal governments on the practice of telemedicine within American
Indian/Alaskan Native (AI/AN) communities. OTJ and DEA invited the
Tribal leaders of all federally recognized Tribes using the Bureau of
Indian Affairs Tribal Leaders Directory, and provided a framing paper
detailing the flexibilities, public engagement, and regulatory actions
taken by DEA in recent years concerning telemedicine. OTJ and DEA
invited Tribal input on any question or topic of interest related to
the use of telemedicine by AI/AN communities, and specifically
requested input on potential regulatory requirements and suggestions on
what would help Tribal governments implement and comply with a future
rule. OTJ and DEA also welcomed the submission of any written comments
as well.
III. Need for Further Rulemaking: Special Registration for Telemedicine
In the process of reviewing and evaluating the comments to the
[[Page 6546]]
proposed 2023 General Telemedicine NPRM and Buprenorphine NPRM, as well
as the presentations made by various stakeholders at the Telemedicine
Listening Sessions, DEA has determined that the best course of action
to ensure patient access to care, while maintaining sufficient
safeguards to detect and protect against the diversion of controlled
substances, is to establish and maintain a separate Special
Registration for Telemedicine (also referred to as simply ``Special
Registration''), i.e., the regulatory scheme Congress specifically
authorized in 21 U.S.C. 802(54)(E) and 21 U.S.C. 831(h). As compared to
the pre-COVID-19 PHE landscape, the Special Registration proposed
herein would allow more comprehensive prescribing, including
prescribing of Schedule II narcotics and non-narcotic controlled
substances in limited circumstances, by properly registered clinician
practitioners and dispensing by platform practitioners with a
legitimate need for the Special Registration.
In determining when a Special Registration should be issued under
21 U.S.C. 802(54)(E), DEA must consider the criteria set forth in 21
U.S.C. 831(h). First, DEA must evaluate a practitioner's legitimate
need for such a Special Registration, as well as clearly define the
limited circumstances under which a Special Registration is
appropriate.\25\ These statutory requirements emphasize the need for
careful consideration when extending prescribing privileges through
telemedicine. This evaluation is crucial in determining whether
telemedicine serves a necessary role, especially given the heightened
risks of diversion and inappropriate prescribing of controlled
substances posed by remote services where a patient has never undergone
an in-person medical evaluation with the prescribing practitioner.
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\25\ 21 U.S.C. 831(h)(1)(A).
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While the COVID-19 PHE created a genuine need for increased use of
telemedicine, it also highlighted the inherent risks associated with
remote prescribing, particularly in the absence of in-person medical
evaluations. In a 2021 Harris Poll online survey conducted on behalf of
Quest Diagnostics, 67 percent of physicians expressed concerns about
missing signs of drug use or use disorders during the COVID-19 PHE, and
75 percent of physicians felt that telemedicine constrained their
ability to assess whether patients were at risk of, or already,
misusing prescription drugs.\26\ Although the telemedicine
flexibilities during the PHE allowing practitioners to prescribe
controlled substances without prior in-person medical evaluations were
necessary to prevent lapses of care amid a global pandemic, it also
facilitated the emergence of concerning business models engaged in the
widespread diversion of controlled substances, taking advantage of the
flexibilities established during the COVID-19 PHE.\27\
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\26\ Majority of Physicians Worry Signs of Addiction Were Missed
During Pandemic, Finds New Quest Diagnostics Health Trends Report,
Quest Diagnostics (Nov. 15, 2021), <a href="https://newsroom.questdiagnostics.com/2021-11-15-Majority-of-Physicians-Worry-Signs-of-Addiction-Were-Missed-During-Pandemic,-Finds-New-Quest-Diagnostics-Health-Trends-R-Report#assets_30649_137302-130:199">https://newsroom.questdiagnostics.com/2021-11-15-Majority-of-Physicians-Worry-Signs-of-Addiction-Were-Missed-During-Pandemic,-Finds-New-Quest-Diagnostics-Health-Trends-R-Report#assets_30649_137302-130:199</a>. While a survey conducted on behalf of a diagnostics
services company, such as Quest Diagnostics, may carry the potential
for bias--given the company's potential preference for traditional
in-person healthcare models--it still offers valuable insights, even
if interpreted with some caution. When considered in context, such
information still provides a unique data point, that when weighted
accordingly, can inform this analysis. The results of the Harris
Poll survey are further reinforced by a 2024 National Center for
Health Statistics (NCHS) Data Brief that shows the percentage of
physicians who feel telemedicine fully provides the same care as in-
person is 4.0 percent for primary care, 6.3 percent for surgical
specialty, and 6.0 percent for medical specialty. Myrick K, Mahar M,
DeFrances CJ. Telemedicine Use Among Physicians by Physician
Specialty: United States, 2021. NCHS Data Brief, no 493. (Feb.
2024), <a href="https://www.cdc.gov/nchs/data/databriefs/db493.pdf">https://www.cdc.gov/nchs/data/databriefs/db493.pdf</a>.
\27\ In June 2024, the founder and clinical president of a
telehealth company were arrested for allegedly participating in a
scheme to distribute Adderall and other stimulants online and
conspiring to commit healthcare fraud. Specifically, they have been
accused of arranging the prescription of over 40 million pills of
Adderall and other stimulants, often with no legitimate medical
purpose. The company allegedly provided easy access to controlled
substances in exchange for a monthly subscription fee, leading to
tragic consequences, including overdoses and deaths. These
allegations underscore DEA's need to judiciously evaluate when a
practitioner has a legitimate need for a Special Registration, and
to ensure that any rule permanently authorizing telemedicine
contains sufficient safeguards. Founder/CEO and Clinical President
of Digital Health Company Arrested for $100M Adderall Distribution
and Health Care Fraud Scheme, U.S. Department of Justice, Press
Release Number: 24-752 (June 13, 2024), <a href="https://www.justice.gov/opa/pr/founderceo-and-clinical-president-digital-health-company-arrested-100m-adderall-distribution">https://www.justice.gov/opa/pr/founderceo-and-clinical-president-digital-health-company-arrested-100m-adderall-distribution</a>.
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Second, DEA may only issue a Special Registration if the
practitioner is ``registered under 21 U.S.C. 823(g) in the state which
the patient will be located'' when receiving the telemedicine
treatment, unless the practitioner is excepted from 823(g)
registration.\28\ Such 823(g) registration in the patient's state is a
critical validation of the practitioner's qualifications and expertise
in prescribing controlled substances within a given state. Moreover,
the definition of ``practice of telemedicine'' under the Ryan Haight
Act requires the practitioner to engage in the practice of medicine
only ``in accordance with applicable Federal and state laws.'' A
special registrant under this proposed framework would need to continue
to comply with the laws and regulations of the state in which
registered, and the laws and regulations of the state in which they are
issuing special registration prescriptions \29\ via a telemedicine
encounter. Thus, where one state's law and regulations are more
restrictive than the other state's law and regulations, the special
registrant would be required to follow the more restrictive state law
and regulations.\30\
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\28\ 21 U.S.C. 831(h)(1)(B).
\29\ Proposed 21 CFR 1300.04 defines a special registration
prescription to mean ``a prescription, defined under [21 CFR
1300.01], for controlled substances issued under a practitioner's
Special Registration for Telemedicine for a legitimate medical
purpose in the usual course of professional practice through the
utilization of an audio-video telecommunications system defined in
Sec. 1300.04 of this chapter.
\30\ Under some circumstances, a special registrant may operate
under a state reciprocity agreement or other form of state
permission that would authorize the special registrant to comply
only with the normally applicable law or regulations of either the
state in which they are registered or the state in which they are
practicing. In other words, states may deem compliance with one
state's normally applicable law and regulations as compliance with
both states' laws and regulations. In this context, DEA would
understand the special registrant to be complying with both states'
laws and regulations, because the special registrant's prescribing
of controlled substances would be authorized by both states.
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Third, in all instances, clinician practitioners ``must establish
and maintain a bonafide doctor-patient relationship in order to act `in
the usual course of . . . professional practice' and to issue a
prescription for a `legitimate medical purpose.' '' \31\ The ``usual
course of professional practice'' is defined by the state in which a
registrant practices, because ``[c]onsistent with the CSA's recognition
of the State's primary role in regulating the practice of medicine, the
[CSA] generally looks to State law and standards of medical practice to
determine whether a doctor and patient have established (and are
maintaining) a bonafide doctor-patient relationship'' at the time of
the prescription.\32\
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\31\ Dewey C. MacKay, 75 FR 49956, 49973 (2010), aff'd, MacKay
v. DEA, 664 F.3d 808 (10th Cir. 2011).
\32\ Id.
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Direct-to-Consumer Online Telemedicine Platforms. In today's
rapidly evolving healthcare landscape, third-party online telemedicine
platforms play a large and integral role, as intermediaries, in the
delivery of remote healthcare to patients beyond traditional medical
settings, with a shift towards predominantly virtual interactions. Many
of these online telemedicine platforms employ a direct-to-consumer
(``DTC'') business model in which they introduce or connect
[[Page 6547]]
patients with a remote clinician practitioner enabling the patient to
be ``seen'' anywhere using a computer or smart phone, forgoing the need
for the patient to go to a medical facility to use the facility's
telecommunications system.
Today's DTC online telemedicine platforms often engage in marketing
to attract new patients, whom they then introduce or match with
clinician practitioners under the platforms' direct employment or
contract. The payment arrangements between the patient and the platform
vary, but some platforms offer subscriptions, where patients pay a
monthly fee for virtual consultations, sometimes up to and including an
unlimited number of consultations, with a clinician practitioner.
Often, but not always, the online telemedicine platform may own and
operate the virtual environment, including the telecommunications
system, where the patient and practitioner virtually ``meet,''
providing the technological infrastructure or support. Unlike
traditional medical settings, the clinician practitioner conducts the
medical evaluation remotely, after which they may prescribe
medications, including controlled substances. While the DTC online
telemedicine platforms are not entirely new, they proliferated in
recent years, in large part due to the COVID-19 pandemic.
Dispensing by Practitioners under the CSA. Although these third-
party, DTC online telemedicine platforms do not directly prescribe to
patients or physically dispense controlled substances to patients,
certain platforms' central involvement as intermediaries in the remote
dispensing of controlled substances qualifies them as ``practitioners''
engaged in ``dispensing'' under the CSA. Under the CSA, to ``dispense''
means ``to deliver a controlled substance to an ultimate user or
research subject by, or pursuant to the lawful order of, a
practitioner, including the prescribing and administering of a
controlled substance.'' \33\ This statutory definition encompasses not
only the physical act of handing out medications, but the broader
process of providing them to patients under the direction of a licensed
healthcare provider.
---------------------------------------------------------------------------
\33\ 21 U.S.C. 802(10).
---------------------------------------------------------------------------
The online telemedicine platforms serving as intermediaries for the
prescribing of controlled substances fall squarely within the CSA's
broad definition of ``practitioner.'' Under the CSA a ``practitioner''
means ``a physician, dentist, veterinarian, scientific investigator,
pharmacy, hospital, or other person licensed, registered, or otherwise
permitted, by the United States or the jurisdiction in which he
practices or does research, to distribute, dispense, conduct research
with respect to, administer, or use in teaching or chemical analysis, a
controlled substance in the course of professional practice or
research.'' \34\ According to this statutory definition, a
``practitioner'' is not limited solely to individual healthcare
providers, but also encompasses entities permitted by law to distribute
or dispense controlled substances. Furthermore, considering the
evolving nature of healthcare delivery, recognizing certain DTC online
telemedicine platforms as practitioners engaged in dispensing under the
CSA reflects the current landscape of telemedicine practice and ensures
that DEA's regulations remain relevant and responsive to changes in
healthcare technology.\35\
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\34\ Public Law 91-513 and 21 U.S.C. 802(21). The definition of
practitioner has also remained unchanged since the enactment of the
original CSA.
\35\ See Senate Report 110-521, Ryan Haight Online Pharmacy
Consumer Protection Act of 2007, accompanying S.980, November 17,
2008 (providing ``[c]ertain telemedicine practices are exempted from
the in-person medical evaluation requirement. The Committee
recognizes that telemedicine is a practice tool that can improve
health outcomes and reduce costs. It is not the intent of the
Committee to restrict the legitimate practice of telemedicine or the
emerging practices of telemedicine which are consistent with medical
practice guidelines of the State in which the practitioner is
licensed, provided such practices do not contravene the goal of
effectively controlling the diversion of controlled substances'').
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DEA Registration of Intermediaries. The registration of
telemedicine intermediaries is not a novel concept. In fact, when
Congress amended the CSA with the Ryan Haight Act, it recognized the
integral role telepresenters, serving as intermediaries, played in
certain telemedicine models. In 21 U.S.C. 802(54)(A)-(B), Congress
specifically authorized two categories of telemedicine, both involving
an intermediary healthcare provider facilitating a medical evaluation
between a patient and a clinician practitioner located at a distance.
Such intermediaries, in this context, are referred to as
telepresenters. To uphold the integrity of the closed system, Congress
required that such telepresenters, as intermediaries, be registered
with DEA. Registration, the cornerstone of the closed system, helps to
ensure that such intermediaries are qualified and accountable to DEA,
reducing the risk of vulnerabilities or loopholes in this closed system
that could lead to diversion and abuse of controlled substances.\36\
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\36\ In addition to these two telepresenter categories, Congress
created two additional regulatory categories (the special
registration category and the joint rule category) to allow DEA to
carry out its diversion control mission in light of future industry
developments. See Senate Report 110-521, Ryan Haight Online Pharmacy
Consumer Protection Act of 2007, accompanying S.980, November 17,
2008 (noting that the statute provides that the Attorney General and
the Secretary of Health and Human Services may promulgate
regulations that allow for the full practice of telemedicine
consistent with medical practice guidelines, so long as these
regulations continue to effectively control diversion).
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Special Registration of Certain DTC Online Telemedicine Platforms.
Certain modern DTC online telemedicine platforms of today, which play a
substantial and integral role as intermediaries in the remote
dispensing of controlled substances, also require registration with
DEA. These platforms are indispensable for delivering telemedicine
services directly to patients through virtual platforms, in contrast to
the other telemedicine models such as those that utilize telepresenters
under 21 U.S.C. 802(54)(A)-(B). The necessity for oversight of these
newer telemedicine intermediaries is heightened by concerns arising
from business practices that have come to light during and after the
COVID-19 pandemic. These practices include platforms that incentivize
the prescription of controlled substances to patients by practitioners
and the exertion of control over the medications prescribed to
patients. DEA has been informed by some clinicians that there have been
instances when they terminated their relationship with an online
telemedicine platform and, in doing so, forfeited access to their
patient's medical records stored by the platform. This renders such
records non-compliant with DEA regulations, which mandate that the
records be readily retrievable by the practitioner, because they become
entirely inaccessible to the clinician practitioner.
As discussed in further detail below, DEA is proposing the Special
Registration of these DTC online telemedicine platforms when they meet
the proposed regulatory definition of a covered online telemedicine
platform. DEA is proposing a definition for covered online telemedicine
platform, delineating the criteria that indicate their substantial and
integral role as intermediaries in the remote dispensing of controlled
substances, qualifying them as practitioners engaged in dispensing
under the CSA and subject to the requirements imposed upon non-
[[Page 6548]]
pharmacist practitioners \37\ under the Controlled Substances Act and
its regulations.
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\37\ See supra footnote 15.
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When any one of the four outlined factors are present, it
solidifies the platform's role as an integral intermediary in the
remote dispensing of controlled substances.\38\ The proposed definition
and criteria are intended to provide a practical and clear framework
for identifying when a DTC online telemedicine platform's conduct
qualifies them as a covered online telemedicine platform, mandating
registration as a dispenser with DEA.\39\ As proposed, this definition
is intended to limit the Special Registration requirements only to
those DTC online telemedicine platforms that play a substantial and
integral role as intermediaries in the remote dispensing of controlled
substances.
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\38\ The behaviors listed in these four factors are included
solely to determine whether a platform is serving as an integral
intermediary. Federal, state, or local laws and/or regulations may
impose statutory or regulatory requirements related to these
behaviors. The inclusion of these behaviors in the definition of
covered online telemedicine platform does not indicate that such
behaviors are permitted under any particular law or regulation.
\39\ The definition of covered online telemedicine platform and
the four criteria are discussed in further detail below in the
NPRM's discussion of proposed regulatory definitions.
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The definition of covered online telemedicine platform also
explicitly excludes certain types of entities, including hospitals,
clinics, insurance providers, and local in-person medical practices.
Local in-person medical practice is, in turn, defined by this rule to
be a medical practice where all its offices are within 100 miles of
each other, and where less than 50 percent of the total prescriptions
for controlled substances collectively issued by the practice's
physicians and mid-level practitioners are issued via telemedicine in
any given calendar month, but is not a hospital, clinic, or insurance
provider. The type of entities excluded from the definition of covered
online telemedicine platform are entities that engage in conduct that
could potentially fall under the definition's criteria but are not the
types of entities whose primary business operations rely on, or center
around, telemedicine services. Moreover, it should be noted that the
proposed definition of local in-person medical practice uses the term
``telemedicine'' rather than ``practice of telemedicine.'' This
distinction is significant, as ``telemedicine'' is used in its general,
colloquial sense, whereas the ``practice of telemedicine'' carries the
specific statutory meaning defined by the Ryan Haight Act.
Determining whether an entity dispenses controlled substances and
meets the criteria of a covered online telemedicine platform is a fact-
specific inquiry. If there is any uncertainty regarding the entity's
role as a dispenser, particularly concerning its involvement in the
practitioner-patient relationship, registering may be advisable to
avert the risk of enforcement action based on potential unregistered,
and thus illegal, dispensing of controlled substances.
IV. Section-by-Section Discussion of Proposed Rule
The proposed regulations discussed below are designed to satisfy
the statutory mandates of 21 U.S.C. 831(h) and 21 U.S.C. 802(54)(E),
while fulfilling DEA's core responsibilities of regulating controlled
substances and adapting to the evolving landscape of telemedicine,
including the rise of new types of DTC online telemedicine platforms
engaged in dispensing of controlled substances. Before discussing the
proposed regulations, it is important to once again highlight what they
do not govern or permit. First, as emphasized previously, the proposed
regulations do not affect practitioner-patient relationships in cases
where an in-person medical evaluation has occurred at any point within
the relationship. Once an in-person medical evaluation has taken place,
the practitioner-patient relationship falls outside the scope of the
Ryan Haight Act and the DEA regulations implementing the Ryan Haight
Act. Second, these proposed regulations primarily focus on the practice
of telemedicine under the Special Registration framework authorized by
the Ryan Haight Act.\40\ Other categories of telemedicine established
by the Ryan Haight Act, such as telemedicine occurring during a public
health emergency declared by HHS as authorized under 21 U.S.C.
802(54)(D), are not subject to the registration, prescription, and
recordkeeping and reporting regulations proposed in this NPRM.
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\40\ Ryan Haight Online Pharmacy Consumer Protection Act of
2008, Public Law 110-425, 122 Stat. 4820, Sec. 3(a) (2008)
(codified as amended in 21 U.S.C. 802(54)(E)).
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Third, these proposed regulations would not apply in the absence of
a prescription for controlled substances.\41\ In other words,
practitioners would not be required to obtain a Special Registration
unless they wish to prescribe or otherwise dispense controlled
substances to patients via telemedicine encounters. And fourth, the
proposed regulations would only permit the prescribing of controlled
substances through telemedicine by clinician practitioners. Under the
Special Registration framework, clinician practitioners would not be
authorized to engage in other modes of ``dispensing,'' such as
``administering'' controlled substances to patients via
telemedicine.\42\
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\41\ This is an important distinction given potential conflation
between colloquial use of the term ``telemedicine'' and the
statutory definition of the ``practice of telemedicine'' in the CSA
and these proposed regulations. To illustrate this point, the
following scenarios are non-exhaustive examples in which
``telemedicine'' may occur in the colloquial sense but would not
constitute the ``practice of telemedicine'' under the CSA or these
proposed regulations: (1) a practitioner issues a prescription for a
non-controlled substance; (2) a practitioner treats the patient
through audio-visual means and, after doing so, determines the
patient does not require controlled substances; or (3) a
practitioner is a mental health counselor who treats patients using
``talk therapy'' exclusively, without prescribing controlled
substances.
\42\ 21 U.S.C. 802(2) defines ``administer'' to mean the
``direct application of a controlled substance to the body of a
patient or research subject by a practitioner (or, in his presence,
by his authorized agent), or the patient or research subject at the
direction and in the presence of the practitioner, whether such
application be by injection, inhalation, ingestion, or any other
means.''
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A. Registration Requirements Under 21 CFR Part 1301
As discussed earlier, registration is the cornerstone of the closed
system of control for manufacturing, distribution, and dispensing of
controlled substances, and requires any person who manufactures,
distributes, dispenses, imports, exports, or conducts research or
chemical analysis with controlled substances to register with DEA,
unless otherwise exempted. Establishing a Special Registration for
telemedicine would enhance patient access to care by allowing certain
practitioners to prescribe controlled substances via telemedicine
without the limitations of geographical barriers. At the same time, it
would establish the appropriate circumstances and guardrails for
telemedicine-based prescribing and dispensing of controlled substances
where an in-person medical evaluation has never been performed by the
prescribing practitioner. The rise of DTC online telemedicine platforms
in recent years has further transformed healthcare delivery, but it has
also introduced new challenges and heightened risks of diversion due to
the remote nature of care delivery. The proposed registration
requirements for telemedicine-based prescribing and dispensing create a
new business activity within DEA's overarching registration framework,
distinguishing it from the traditional modes of dispensing under a 21
U.S.C. 823(g) registration.
[[Page 6549]]
1. Three Types of Special Registration; Registrant Eligibility
The proposed requirements for the Special Registration \43\ are
devised to meet the statutory requirements of 21 U.S.C. 831(h). This
provision authorizes DEA to issue a Special Registration if the
practitioner demonstrates a legitimate need for a Special
Registration.\44\ Moreover, this statutory provision requires DEA to
promulgate regulations specifying the limited circumstances under which
a Special Registration may be issued and establish clear eligibility
criteria for practitioners and the procedure for seeking a Special
Registration.\45\ To accommodate the varying legitimate needs of
practitioners, including both clinician practitioners and covered
online telemedicine platforms, in their capacity as platform
practitioners, the proposed framework offers three distinct categories
of Special Registrations.
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\43\ Proposed 21 CFR 1301.11.
\44\ 21 U.S.C. 831(h)(1)(A).
\45\ Id.; 831(h)(2)(A).
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The first category, the Telemedicine Prescribing Registration,
would authorize the prescribing of Schedules III through V controlled
substances by clinician practitioners.\46\ The second category, the
Advanced Telemedicine Prescribing Registration, would authorize certain
specialized clinician practitioners the privilege to prescribe not only
Schedule III through V controlled substances, but Schedule II
controlled substances as well,\47\ even though such substances have
higher potential for abuse and dependence.\48\ And lastly, the third
category, the Telemedicine Platform Registration, would authorize
covered online telemedicine platforms to dispense Schedules II through
V controlled substances through a clinician practitioner possessing
either a Telemedicine Prescribing Registration or an Advanced
Telemedicine Prescribing Registration.\49\
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\46\ Proposed 21 CFR 1301.11(c)(2).
\47\ Proposed 21 CFR 1301.11(c)(3).
\48\ See 21 U.S.C. 812(b)(2), (3).
\49\ Proposed 21 CFR 1301.11(c)(4).
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Under proposed Sec. 1301.11(c)(1)(A), an applicant for one of the
three types of Special Registration would be required to already have
one or more DEA registrations under 21 U.S.C. 823(g) to prescribe (if
an clinician practitioner) or dispense (if a platform practitioner)
controlled substances in a state in which they are licensed,
registered, or otherwise permitted to prescribe or dispense controlled
substances through telemedicine, unless they are otherwise exempted.
This requirement for Special Registration streamlines the review
and approval process for applications for Special Registrations by
building upon the checks and assessments already conducted for 21
U.S.C. 823(g) registrations. While the proposed framework allows for VA
practitioners to seek and obtain a Special Registration, DEA and HHS
have also jointly promulgated the Continuity of Care via Telemedicine
for Veterans Affairs Patients final rule (RIN 1117-AB88), published
elsewhere in this issue of the Federal Register, which specifically
addresses the practice of telemedicine within the VA health care
system. As discussed above, a DTC online telemedicine platform that
qualifies as a covered online telemedicine platform dispenses
controlled substances and must register with DEA in its capacity as a
dispenser. It also bears emphasizing that proposed Sec. 1301.11(c)(1)
requires that covered online telemedicine platforms, like their
clinician practitioner counterparts, already have one or more DEA
registrations under 21 U.S.C. 823(g) to dispense controlled substances;
DEA registrations under 21 U.S.C. 823(g) in turn require licensing of
the activity by the state in which DEA registration under 21 U.S.C.
823(g) is sought.
Proposed Sec. 1301.11(c)(1)(i) makes it clear that those officials
for whom the requirement of registration to prescribe is generally
waived under Sec. 1301.23(a) of this chapter must still obtain a
Telemedicine Prescribing Registration or Advance Telemedicine
Prescribing Registration before issuing special registration
prescriptions.\50\ Such officials are, as described below, exempt from
obtaining State Telemedicine Registrations, though they must identify
all the states in which patients will be treated via telemedicine on
their registration application.
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\50\ 21 CFR 1301.23(a) waives the requirement of registration
``for any official of the U.S. Army, Navy, Marine Corps, Air Force,
Space Force, Coast Guard, Public Health Service, or Bureau of
Prisons who is authorized to prescribe, dispense, or administer, but
not to procure or purchase, controlled substances in the course of
his/her official duties.''
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a. Telemedicine Prescribing Registration (Schedules III-V) Clinician
Practitioners Eligibility
To be eligible for the Telemedicine Prescribing Registration under
proposed Sec. 1301.11(c)(2), clinician practitioners would need to
demonstrate that they have a legitimate need for a Special
Registration. DEA has determined that physicians and board-certified
mid-level practitioners (defined under 21 CFR 1300.01) have a
legitimate need to prescribe Schedules III through V controlled
substances when they anticipate that they will be treating patients for
whom requiring in-person medical evaluations prior to prescribing
Schedule III-V controlled substances could impose significant burdens
on bona fide practitioner-patient relationships. For example,
practitioners may have a legitimate need for the Special Registration
when their patients face significant challenges in attending in-person
medical evaluations, such as severe weather conditions, living in
remote or distant areas, or having communicable diseases, which make
in-person appointments difficult or even unadvisable.
b. Advanced Telemedicine Prescribing Registration (Schedules II-V)
Clinician Practitioner Eligibility
To be eligible for the Advanced Telemedicine Prescribing
Registration under proposed Sec. 1301.11(c)(3), physicians and mid-
level practitioners, as clinician practitioners, would not only need to
demonstrate they have a legitimate need for the Special Registration
but that such need warrants the authorization of prescribing of
Schedule II controlled substances in addition to Schedules III through
V controlled substances. DEA has determined that certain specialized
physicians and board-certified mid-level practitioners have a
legitimate need to prescribe Schedule II controlled substances via
telemedicine when treating particularly vulnerable patient populations.
Such authorization is reserved only for the most compelling use cases,
ensuring that Schedule II prescribing via telemedicine is used only
when necessary.
Consistent with these concerns regarding vulnerable patient
populations, and cognizant of the high potential for abuse that exists
for Schedule II controlled substances, DEA has determined that only
certain specialized physicians and board-certified mid-level
practitioners have a legitimate need for the Advanced Telemedicine
Prescribing Registration, in the following limited circumstances or
practice specialties:
(1) psychiatrists;
(2) hospice care physicians;
(3) palliative care physicians;
(4) physicians rendering treatment at long term care facilities;
(5) pediatricians; \51\
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\51\ Proposed 21 CFR 1306.45(e) would also require that the
parent or guardian of patients under the age of 18 be present in the
room with the patients when the patients are being issued
prescriptions for a Schedule II controlled substance.
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[[Page 6550]]
(6) neurologists; and
(7) mid-level practitioners and physicians from other specialties
who are board certified in the treatment of psychiatric or
psychological disorders, hospice care, palliative care, pediatric care,
or neurological disorders unrelated to the treatment and management of
pain.
The type of specialized practitioners and board-certified mid-level
practitioners eligible for the Advanced Telemedicine Prescribing
Registration typically treat patients that face significant healthcare
accessibility challenges, and, in some cases, who suffer from
particularly debilitating or terminal illnesses. The hardships faced by
such patients were discussed at length by certain speakers during the
Telemedicine Listening Sessions. For example, some speakers discussed
accessibility issues created by shortages of psychiatrists, and the
need for qualified, perhaps board-certified, psychiatrists to diagnose
and treat illnesses like ADHD.\52\ Another group of speakers addressed
the accessibility challenges faced by palliative and hospice patients,
often homebound, who may need urgent pain treatment and symptom
management.\53\ The heightened specificity of these limited
circumstances is intended to strike a balance between ensuring access
to necessary medications for vulnerable patients while controlling the
prescribing of Schedule II controlled substances that have a higher
potential risk of abuse and dependence.
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\52\ See Telemedicine Listening Sessions, Georgia Gaveras
(Talkiatry), 21:6-22:4, 25:1-8 (Sept. 12, 2023); John Heaphy (NY
State Dep. of Health, Mental Health), 76:10-77:14 (Sept. 13, 2023);
and Caitlin Gilloley (American Hospital Association), 63:21-64:14
(Sept. 13, 2023).
\53\ See Telemedicine Listening Sessions, David Hoffman
(Columbia University), 44:17-44:23, 45:16-21, 46:19-21 (Sept. 12,
2023); Robin Plumer, M.D., 190:18-191:17 (Sept. 12, 2013); Kevin
Duane, PharmD, 206:16-207:1 (Sept. 12, 2023); Joseph Rotella, M.D.
(American Academy of Hospice and Palliative Medicine), 289:25-290:12
(Sept. 12, 2023); Alex Armitage, M.D. (Baylor Scott & White Health),
43:8-14, 43:24-44:10 (Sept. 13, 2023); and Caitlin Gilloley
(American Hospital Association), 63:21-64:14 (Sept. 13, 2023).
---------------------------------------------------------------------------
Furthermore, these eligible specialized physicians and board-
certified mid-level practitioners are uniquely positioned to provide
expert care for specific, vulnerable patient populations. These
specialized physicians and mid-level practitioners have specialized
training and in-depth knowledge to equip them to make informed
decisions regarding the use of Schedule II controlled substances when
prescribed remotely to particularly vulnerable patient groups. While
DEA is not proposing regulations that delineate specific criteria for
practitioners falling into the designated practice specialties,
clinician practitioners are required to furnish information on their
Special Registration applications that would demonstrate their
specialized training. For example, the clinician practitioner could
cite or provide information on board certification in a specialty,
specialized training, or the percentage of the clinician practitioner's
overall practice that falls within one of the specialized practices.
Mid-level practitioners are, however, required to be board-certified
under this proposed framework. DEA invites public comments on all
facets of the proposed regulations, including this specific
provision.\54\ Particularly, DEA seeks input on whether other types of
practitioners should be included if they can demonstrate specific
training in expertise in managing conditions that are traditionally
treated with Schedule II controlled substances. DEA also seeks input on
alternative methods to ensure that practitioners seeking to prescribe
Schedule II controlled substances pursuant to the Advanced Telemedicine
Prescribing Registration have the appropriate training and expertise to
do so safely.
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\54\ See Appendix B for Chart: Which Special Registration for
Telemedicine Do I Need as a Clinician Practitioner?
---------------------------------------------------------------------------
c. Telemedicine Platform Registration (Schedules II-V) Platform
Practitioner Eligibility
To be eligible for the Telemedicine Platform Registration under
proposed Sec. 1301.11(c)(4), covered online telemedicine platforms
would need to demonstrate that they have a legitimate need for a
Special Registration. DEA has determined that covered online
telemedicine platforms (defined under 21 CFR 1300.04), in their
capacity as platform practitioners, have a legitimate need to dispense
Schedules II through V controlled substances when they anticipate
providing necessary services to introduce or facilitate connections
between patients and clinician practitioners via telemedicine for the
diagnosis, treatment, and prescription of controlled substances, are
compliant with federal and state regulations, provide oversight over
clinician practitioners' prescribing practices, and take measures to
prioritize patient safety and prevent diversion, abuse, or misuse of
controlled substances. The platform practitioner would be required to
attest to its legitimate need on their special registration
application. If, however, it is later discovered that the practitioner
provided false information to obtain the special registration or used
it for unlawful or inappropriate purposes, the practitioner could be
found in violation of 21 U.S.C. 824(a), which could lead to penalties
such as revocation or suspension of the registration.
As discussed previously, the registration of covered online
telemedicine platforms within the Special Registration framework is
necessary given the pivotal role they sometimes play in the delivery of
healthcare through telemedicine. While these covered online
telemedicine platforms may improve healthcare accessibility by
connecting patients with clinician practitioners, their emergence also
brings more, and sometimes easier, avenues to divert or abuse
controlled substances, particularly when such entities have financial
incentives tied to prescriptions and/or do not adequately screen the
clinician practitioners utilizing their system or platform. The lack of
proper oversight and verification of clinician practitioners'
credentials open the door to ``doctor shopping'' \55\ on the systems or
platforms, particularly when bad actors are aware of, and exploit, the
lack of oversight and credential verification by covered online
telemedicine platforms.
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\55\ Bollmeier SG, Stevenson E, Finnegan P, Griggs SK. Direct to
Consumer Telemedicine: Is Healthcare from Home Best? Mo Med. 2020
Jul-Aug;117(4):303-309. PMID: 32848261; PMCID: PMC7431063. See also,
Temporary Extension of COVID-19 Telemedicine Flexibilities for
Prescription of Controlled Medications, 88 FR 30037, 30040 (May 10,
2023). As discussed in the First Temporary Rule, while the conduct
of certain online telemedicine platforms has raised concerns and
such platforms may be subject to investigation for problematic
prescribing practices, many others have acted in good faith to
expand access to care. ``Doctor shopping is defined as seeing
multiple treatment providers, either during a single illness episode
or to procure prescription medications illicitly.'' Sansone RA,
Sansone LA. Doctor shopping: a phenomenon of many themes. Innov Clin
Neurosci. 2012 Nov;9(11-12):42-6. PMID: 23346518; PMCID: PMC3552465.
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2. Ancillary Registration: State Telemedicine Registrations
Pursuant to 21 U.S.C. 802(54), the practice of telemedicine,
including such practice authorized under a Special Registration, must
be ``in accordance'' or consistent with Federal and State law. Section
831(h)(1)(B) authorizes DEA to issue a Special Registration to a
practitioner if the practitioner is registered under 21 U.S.C. 823(g)
in the state in which the patient is located when receiving a
prescription for controlled substance via telemedicine (a ``823(g)
patient state registration), subject to certain exceptions. While the
proposed Special Registration framework must comply with these
[[Page 6551]]
statutory provisions, DEA is mindful that telemedicine is largely
designed to overcome geographical constraints. Therefore, to reduce the
administrative burden and cost on special registrants, DEA is proposing
a limited type of 21 U.S.C. 823(g) registration for a lower
registration fee, the State Telemedicine Registration.
Pursuant to proposed Sec. 1301.11(d), a clinician special
registrant would be required to obtain a State Telemedicine
Registration, which is a DEA-issued registration and not a registration
issued by the individual states, for every state in which they intend
to issue prescriptions for controlled substances to patients via
telemedicine. Likewise, a platform special registrant would be required
to obtain a State Telemedicine Registration for every state in which it
dispenses Schedule II-V controlled substances to a patient. The State
Telemedicine Registration would operate as an ancillary credential,
contingent on the Special Registration held by the clinician
practitioner or platform practitioner. In other words, a State
Telemedicine Registration for a given state would allow the special
registrant to prescribe only via telemedicine encounters as to that
state, and only for the scheduled controlled substances authorized by
their Special Registration (i.e., Telemedicine Prescribing
Registration, Advanced Telemedicine Prescribing Registration, or
Telemedicine Platform Registration).
Proposed 21 CFR 1301.11(d) stipulates that a practitioner's
eligibility for the State Telemedicine Registration for a specific
state depends on their authorization, such as state licensure or state-
level registration, to prescribe or otherwise dispense controlled
substances through telemedicine within that state. Consistent with the
criteria for all 823(g) registrations, DEA will consider the public
interest factors outlined in 21 U.S.C. 823(g)(1)(A)-(E) before granting
a State Telemedicine Registration. The requirement of state
authorization aligns with 21 U.S.C. 823(g)(1)(D), which assesses
compliance with state, federal, and local laws regarding controlled
substances.
Exemptions to the State Telemedicine Registration Requirement.
Section 21 U.S.C. 831(h)(1)(B) does, however, provide two categories of
exemptions to the state registration requirement. Generally, a
clinician special registrant would not be required to obtain a section
823(g) registration in each patient state to prescribe via
telemedicine, if the clinician special registrant is either: (1)
subject to a regulatory exemption applicable to all states pursuant to
21 U.S.C. 822(d),\56\ or (2) the clinician special registrant is an
employee or contractor of the VA.\57\
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\56\ Pursuant to 21 U.S.C. 822(d), ``[t]he Attorney General may,
by regulation, waive the requirement for registration of certain
manufacturers, distributors, or dispensers if he finds it consistent
with the public health and safety.''
\57\ 21 U.S.C. 802(54)(A)(ii)(III).
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As to the first category of exemptions, there is currently one
regulatory exemption, promulgated pursuant to 21 U.S.C. 822(d),
applicable to registration in all states. Specifically, 21 CFR
1301.23(a) waives registration ``for any official of the U.S. Army,
Navy, Marine Corps, Air Force, Space Force, Coast Guard, Public Health
Service, or Bureau of Prisons who is authorized to prescribe, dispense,
or administer, but not to procure or purchase, controlled substances in
the course of his/her official duties.'' The second category of
exemptions is the one explicitly extended to VA employees or
contractors by statute.\58\ When an employee or contractor of the VA is
acting in the scope of such employment or contract, and is registered
under section 823(g) in any state or is utilizing the registration of a
hospital or clinic operated by the VA registered under 21 U.S.C.
823(g), the prescriber would not need to possess a State Telemedicine
Registration in each state in which a patient is located.\59\
---------------------------------------------------------------------------
\58\ 21 U.S.C. 802(54)(A)(ii)(III)(bb).
\59\ 21 U.S.C. 831(h)(1)(B)(i)-(ii).
---------------------------------------------------------------------------
While proposed Sec. 1301.11(d) incorporates these exemptions,
those clinician practitioners who are exempted from the State
Telemedicine Registration requirement remain subject to other Special
Registration eligibility requirements and are required to identify all
the states in which patients will be treated via telemedicine on their
registration application for the Telemedicine Prescribing Registration
or the Advanced Telemedicine Prescribing Registration. DEA must have
this information to coordinate oversight and verify that State
Telemedicine Registration-exempted clinician special registrants are
operating within the boundaries of their exemption while upholding
regulatory standards. The State Telemedicine Registration-exempted
clinician special registrants would also be exempted from the $50 fee
per state under proposed 21 CFR 1301.13(e)(1)(xiii), further discussed
below.\60\
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\60\ See Appendix C for Chart: Which State Telemedicine
Registrations Do I Need, If Any?
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3. Special Registration Application Process
The Special Registration application process for obtaining the
proposed Telemedicine Prescribing Registration, Advanced Telemedicine
Prescribing Registration, and the Telemedicine Platform Registration
would differ from the standard 21 U.S.C. 823(g) registration
application process. The proposed amendments to 21 CFR 1301.13 outline
the new Special Registration application requirements.
a. Special Registration Application, Cycles, Fees, Generally
Proposed 21 CFR 1301.13(e)(1)(xi)-(xv) summarizes the Special
Registration Application, Cycle, and Fees. DEA proposes issuing a new
registration application, Form 224S (Application for Special
Registration for Telemedicine Under the Controlled Substances Act),
tailored for Special Registrations. Special Registration applicants
would use the Form 224S to apply for one of the three types of the
Special Registration (i.e., Telemedicine Prescribing Registration,
Advanced Telemedicine Prescribing Registration, or Telemedicine
Platform Registration), as well as the State Telemedicine Registrations
for each state in which telemedicine patients will be located. The
regulations propose a tiered fee structure to address the
administrative demands specific to the new business activities. The
regulations propose a three-year cycle for the Special Registrations
(i.e., Telemedicine Prescribing Registration, Advanced Telemedicine
Prescribing Registration, and Telemedicine Platform Registration), as
well as the State Telemedicine Registrations (i.e., Clinician
Practitioner State Telemedicine Registration and the Platform
Practitioner State Telemedicine Registration).
For any one of the three types of Special Registration, the
registration fee would be $888. The fee for the Platform Practitioner
State Telemedicine Registration would be $888 for each state in which a
State Telemedicine Registration is sought; however, the Clinician
Practitioner State Telemedicine Registration would be discounted to $50
for each state in which the clinician practitioner sought a State
Telemedicine Registration.\61\ The fee for the State Telemedicine
Registration for clinician practitioners is discounted to account for
the expected
[[Page 6552]]
lower volume of telemedicine that would be conducted by clinician
practitioners compared to covered online telemedicine platforms. The
$50 registration fee for the Clinician Practitioner State Telemedicine
Registration would be waived for those exempted from registration
pursuant to 21 U.S.C. 831(h)(1)(B) and proposed 21 CFR 1301.11(c)(3).
In DEA's preliminary assessment, the registration fees are reasonable
and are expected to account for the full operating costs associated
with the heightened administrative and resource demands on the
Diversion Control Program that will arise from regulating a new
registration class; however, DEA may adjust these fees as it acquires
additional information about the new registration classes to ensure
appropriate funding for regulatory oversight.\62\
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\61\ 21 CFR 1301.21 exempts certain clinician practitioner
applicants from payment of application fees for registration,
including for Special Registrations and State Telemedicine
Registrations.
\62\ Pursuant to 21 U.S.C. 821, DEA is authorized to charge
reasonable fees relating to registration and control of the
dispensing (including prescribing) of controlled substances.
Furthermore, 21 U.S.C. 886a(1)(C) requires those fees to be set at a
level that ensures the recovery of the full costs of operating the
various aspects of the Diversion Control. Program. For more
information on fee scheduling, see Registration and Reregistration
Fees for Controlled Substance and List I Chemical Registrants, 85 FR
44710-44734 (July 24, 2020).
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b. Supplemental Requirements on Special Registration Application (Form
224S)
Special Registered Location. Pursuant to proposed Sec.
1301.13(k)(1), all Special Registration applicants would be required to
designate one of their existing 21 U.S.C. 823(g) registered locations
as the registered location/physical address (``special registered
location'') of their Special Registration. The special registered
location would serve as the physical point of contact for DEA
telemedicine inquires and compliance actions. As will be further
discussed below, the proposed rule would also mandate that the records
arising from telemedicine encounters under the Special Registration be
maintained at the special registered location.\63\ Such centralized
recordkeeping would allow DEA to more efficiently review records and
ensure that prescriptions are being issued in accordance with DEA
regulations. Proposed Sec. 1301.13(k)(1) would provide an exemption
for applicants who are exempted from the State Telemedicine
Registration requirement under proposed Sec. 1301.11(d); however, such
exempted persons would be required to provide another physical address
on the application to serve as their special registered location.
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\63\ See Proposed 21 CFR 1304.04(j).
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Form 224S Supplementary Disclosures and Attestations. Proposed 21
CFR 1301.13(k)(2) would require the Special Registration applicant to
provide certain disclosures and attestations on the Form 224S. Such
information would enhance transparency, patient safety, and anti-
diversion efforts. First, proposed Sec. 1301.13(k)(2)(i) would require
platform practitioners applying for the Telemedicine Platform
Registration to attest to all employment, contractual relationships, or
professional affiliations with any clinician special registrant and
Online Pharmacy and their respective registration numbers on the Form
224S. Likewise, proposed Sec. 1301.13(k)(2)(ii) would require
clinician practitioners applying for the Telemedicine Prescribing
Registration or the Advanced Telemedicine Prescribing Registration to
attest to all employment, contractual relationships, and professional
affiliations, including but not limited to those with covered online
telemedicine platforms (and the respective online telemedicine
platform's Telemedicine Platform Special Registration number, if
applicable) on the Form 224S. By understanding each prescriber's
professional associations, DEA can more effectively evaluate the
prescriber's qualifications, conflicts of interest, and compliance with
DEA regulations.\64\ Second, proposed Sec. 1301.13(k)(2)(iii) would
require that clinician practitioners and platform practitioners
applying for a Special Registration to attest that they have devised,
and are committed to maintaining, anti-diversion policies and
procedures.
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\64\ See Telemedicine Listening Sessions, Dr. Shabana Khan
(American Psychiatric Association and American Academy of Child and
Adolescent Psychiatry), 38:16-19 (Sept. 12, 2023) (recommending that
DEA could require the reporting of the prescriber's employer to hold
the telemedicine employers accountable).
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Third, proposed Sec. 1301.13(k)(2)(iv) would require clinician
practitioners applying for the Advanced Telemedicine Prescribing
Registration to disclose their practice specialties, e.g. hospice care
or palliative care. DEA would use this information in conjunction with
other investigative information to help detect and prevent diversion of
controlled substances via telemedicine. This would include
circumstances where clinician practitioners appear to be prescribing
medications for conditions unrelated to their practice specialties. DEA
would also use this information as needed to check the applicant's
eligibility for the Advanced Telemedicine Prescribing Registration,
which is limited to certain specialized physicians and mid-level
practitioners treating vulnerable patient populations who have a
legitimate need to prescribe Schedule II controlled substances.
As discussed above, under the proposed 21 CFR 1301.11(c)(3), only
psychiatrists, hospice care physicians, palliative care physicians,
physicians rendering treatment at long term care facilities,
pediatricians, neurologists, and mid-level practitioners board
certified in the treatment of psychiatric or psychological disorders,
hospice care, palliative care, pediatric care, or neurological
disorders unrelated to the treatment and management of pain, would be
eligible for the Advanced Telemedicine Prescribing Registration.
Lastly, proposed Sec. 1301.13(k)(2)(v) would require that, for each
type of Special Registration, the applicant required to attest to their
legitimate need on their special registration application. If, however,
it is later discovered that practitioner provided false information to
obtain the Special Registration or used it for unlawful or
inappropriate purposes, they could be found in violation of 21 U.S.C.
824(a), which could lead to penalties such as revocation or suspension
of registration.
c. Notification of Application Changes; Modifications (Form 224S-M)
Proposed 21 CFR 1301.13(l) would require special registrants to
promptly notify DEA of any changes to the information provided in their
original Special Registration application (Form 224S) within 14
business days on a Form 224S-M (Application for Changes and
Modifications to Special Registration). For example, if a clinician
special registrant began employment with, or otherwise entered an
arrangement with, a new DTC online telemedicine platform not previously
disclosed on their original Form 224S, the clinician special registrant
would be required to submit a Form 224S-M to DEA within 14 business
days of any such change. The Form 224S-M would also be used by
clinician special registrants and platform special registrants to make
modifications to their Special Registration. For example, the special
registrant would submit a Form 224S-M to apply for additional State
Telemedicine Registrations to engage in telemedicine in states for
which the special registrant did not originally apply on their Form
224S.
[[Page 6553]]
4. Special Registration for Telemedicine Actions
a. Approval and Denial of Special Registration Applications
Proposed amendments to 21 CFR 1301.35 address the approval and
denial criteria that would be considered on an application for Special
Registration under 21 U.S.C. 831(h). The proposed amendment to Sec.
1301.35(a) states that the Administrator shall issue a Certificate of
Registration (DEA Form 223) to a Special Registration applicant if: (1)
the Special Registration applicant satisfies the eligibility
requirements specified at proposed 21 CFR 1301.11(c)(2) (Telemedicine
Prescribing Registration), proposed 21 CFR 1301.11(c)(3) (Advanced
Telemedicine Prescribing Registration), proposed 21 CFR 1301.11(c)(4)
(Telemedicine Platform Registration) or proposed 21 CFR 1301.11(d)
(State Telemedicine Registration); and (2) after considering the public
interest factors provided at 21 U.S.C. 823(g)(1)(A)-(E), the
Administrator has determined that the Special Registration will be
consistent with the public interest.
By evaluating Special Registration applicants on the eligibility
requirements and considering the public interest factors under Section
823(g), DEA can ensure that only qualified practitioners, whether a
clinician practitioner or a platform practitioner, who prioritize
public safety and regulatory compliance are granted Special
Registrations for Telemedicine. As is required for applications for
other registrations (issued under 21 U.S.C. 823 and 21 U.S.C. 958),
proposed 21 CFR 1301.35(a) requires the Administrator--if intending to
deny an application--to issue an Order to Show Cause pursuant to 21 CFR
1301.37,\65\ and, if requested by the applicant, hold a hearing on the
application pursuant to 21 CFR 1301.31 for Special Registration
Applications.
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\65\ 28 CFR Pt. 0, Subpt. R., App., Sec. 7 delegates the
authority to sign final orders connected with the suspension,
denial, or revocation of registration to the Deputy Assistant
Administrator of the DEA Office of Diversion Control.
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Proposed 21 CFR 1301.35(d) would specify what information a
Certificate of Registration (DEA Form 223) issued for a Special
Registration shall contain: name; special registered location; Special
Registration for Telemedicine (Telemedicine Prescribing Registration,
Advanced Telemedicine Prescribing Registration, or Telemedicine
Platform Registration), and State Telemedicine Registration(s); the
activity authorized by the Special Registration, the Schedules and/or
Administration Controlled Substances Code Number (as set forth in part
1308 of this chapter) of the controlled substances which the registrant
is authorized to handle; the amount of fee paid (or exemption) for each
registration, and the expiration date of each registration. Proposed 21
CFR 1301.35(d) would also require a special registrant to maintain the
Certificate of Registration at the special registered location in a
readily retrievable manner and to permit inspection of the certificate
by any official, agent or employee of the DEA or of any Federal, State,
or local agency engaged in enforcement of laws relating to controlled
substances.
b. Suspension and Revocation of Special Registrations
The proposed amendments to 21 CFR 1301.36 outline when Special
Registrations for Telemedicine (Telemedicine Prescribing Registration,
Advanced Telemedicine Prescribing Registration, and Telemedicine
Platform Registration), and State Telemedicine Registrations may be
suspended or revoked. Proposed 21 CFR 1301.36(c) would provide that
such Special Registrations for Telemedicine can be suspended or revoked
based on the grounds specified in 21 U.S.C. 824(a), which are
fundamentally designed to authorize DEA to intervene when registrants
jeopardize the responsible handling of controlled substances. A Special
Registration is contingent on the good standing of the registrant's
other DEA registrations; therefore, proposed 21 CFR 1301.36(k)
stipulates that the suspension or revocation of any registration under
21 U.S.C. 823 will trigger an automatic suspension or revocation of any
registration issued under 21 U.S.C. 831. These automatic suspensions
and revocations are designed to prevent registrants who have had one
registration suspended or revoked due to non-compliance or risk to
patient safety, from exploiting alternate registrations.
B. Special Registration Prescriptions Issued by Clinician Special
Registrants Under 21 CFR Part 1306
Proposed 21 CFR 1306.41 through 1306.47 provide heightened
requirements for clinician special registrants when they issue special
registration prescriptions. Along with these heightened special
registration prescription requirements, clinician special registrants
would remain obligated to comply with all prescription regulations
required under their 21 U.S.C. 823(g) registration. The combination of
heightened telemedicine standards and continued adherence to existing
regulations ensures that the quality and integrity of medical practice
are maintained, even in the evolving landscape of remote healthcare
services. Generally, these proposed regulations address the manner in
which prescriptions are issued by clinician special registrants, and
certain elements required to be a part of special registration
prescriptions.
1. Manner of Issuance of Special Registration Prescriptions
Prescription Origination within the United States. Proposed 21 CFR
1306.41 would require that the clinician special registrant be
physically present in the United States when conducting a telemedicine
encounter and issuing a special registration prescription.
Additionally, proposed 21 CFR 1306.41 would require that the clinician
special registrant hold the proper licensure and authorization within
the state and territory where the practitioner is located when the
telemedicine encounter takes place.\66\ For the purposes of this
proposed rule, the ``United States'' means the 50 states of the United
States of America and the District of Columbia, the Commonwealth of
Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands,
the U.S. Virgin Islands, America Samoa, Wake Island, Midway Islands,
Kingman Reef, Johnston Atoll, and any other trust territory or
possession of the United States. This proposed requirement ensures that
DEA retains jurisdictional control over special registration
prescriptions and maintains clear boundaries on where these
prescriptions are issued, ensuring compliance with U.S. laws and
regulations. Restricting clinician special registrants from operating
outside the U.S. also minimizes the risk associated with international
boundaries, such as different regulatory frameworks and potential
challenges in oversight and accountability.
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\66\ The practitioner would also be required to be licensed and
authorized to practice telemedicine in the state where the patient
is located pursuant to the relevant State Telemedicine Registration.
See proposed 21 CFR 1301.11(d).
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Electronic Prescribing for Controlled Substances (EPCS). Proposed
21 CFR 1306.42 requires all special registration prescriptions be
issued through EPCS.\67\ For the practice of telemedicine, in which
physical practitioner-patient interactions do not exist, EPCS would be
instrumental in securing the prescription process. It would establish a
traceable and secure platform that reduces the risk of unauthorized
access
[[Page 6554]]
and forgeries. Moreover, the majority of states have enacted EPCS
mandates to combat the opioid crisis by focusing on opioid access and
enhanced oversight of possible misuse.\68\ According to one 2021 study
of New York's e-prescribing mandate, the mandate reduced the rate of
overdoses involving natural and semi-synthetic opioids by 22
percent.\69\ EPCS offers a robust and accountable system that prevents
misuse and diversion of controlled substances, helping to maintain the
integrity of prescribing among clinician special registrants.
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\67\ Electronic Prescriptions for Controlled Substances, 75 FR
16236 (March 31, 2010).
\68\ EPCS Mandates: Ultimate Guide to 2023 Deadlines <radical>
RXNT (Available: <a href="https://www.rxnt.com/epcs-mandates/">https://www.rxnt.com/epcs-mandates/</a>).
\69\ Abouk R, Powell D. Can Electronic Prescribing Mandates
Reduce Opioid-Related Overdoses? Econ Hum Biol. 2021 Aug;42:101000.
doi: 10.1016/j.ehb.2021.101000. Epub 2021 Apr 9. PMID: 33865194;
PMCID: PMC8222172 (Available: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8222172/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8222172/</a>).
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Nationwide Prescription Drug Monitoring Program (PDMP) Check.
Proposed 21 CFR 1306.43 requires that clinician special registrants
perform a check of relevant PDMPs. For a period of three (3) years from
the date that a final rule becomes effective, before issuing any
special registration prescription for controlled substance to a
patient, the individual special registrant would be required to check
the PDMPs for: (1) the state or territory where the patient is located;
(2) state or territory where the clinician practitioner is located; and
(3) any state or territory with PDMP reciprocity agreements with either
the state or territory where the patient is located or the state or
territory where the clinician practitioner is located. While the
proposed regulation would require, at a minimum, that clinician special
registrants check these three categories, DEA encourages clinician
special registrants to check any other state PDMP that the registrant
determines to be clinically appropriate.
After three years, however, the individual special registrant would
be required, before issuing any special registration prescription for
controlled substances to a patient, to check the PDMPs of all 50 states
of the United States and any other U.S. district or territory that
maintains its own PDMP. This requirement for a broader, nationwide PDMP
check would not begin until three (3) years after the final rule's
effective date, to allow registrants and industry sufficient time to
comply with the new requirement. If, however, there is no mechanism to
perform such a nationwide check after these three years, then
individual special registrants would remain required to continue
performing PDMPs checks of the states in the three categories described
above, and individual special registrants would only be able to issue
special registration prescriptions for Schedule II controlled
substances to patients located within the same state as the individual
special registrant, i.e., where there is an intra-state practitioner-
patient relationship. The proposed nationwide PDMP check requirement is
intended to ensure that clinician practitioners and pharmacists have
full visibility of a patient's controlled substance prescription
history, not to proactively furnish DEA with access to this data.
Accordingly, this rule does not propose that DEA would gain any new
avenues, by means of this rule, to collect information from state PDMPs
beyond what is otherwise authorized by federal and state laws.
This delayed nationwide PDMP check requirement also reflects that
the fragmented nature of PDMPs across states and territories has
created challenges for healthcare providers in obtaining comprehensive
patient data, particularly in cases involving telemedicine. In the
context of telemedicine, the extension of medical services across state
boundaries increases the complexity of controlling diversion of
controlled substances. Telemedicine allows patients to consult
clinician practitioners located in different states, creating a
scenario where patients might seek multiple prescriptions from
different clinician practitioners practicing in different regions, i.e.
``doctor shop,'' by exploiting the current fragmented nature of PDMPs
across the states. Moreover, the absence of in-person interaction with
telemedicine patients may limit the practitioner's ability to gauge
whether patients are being honest about their medical history,
potentially enabling the concealment of pertinent information related
to controlled substances. During the Telemedicine Listening Sessions,
various speakers highlighted the challenges resulting from the
fragmented nature of PDMPs across states and territories and called for
enhanced interoperability of PDMPs nationwide; some speakers also
advocated for a unified national or federal PDMP to address these
concerns more effectively.\70\
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\70\ Telemedicine Listening Sessions, Dr. Shabana Khan (American
Psychiatric Association and American Academy of Child and Adolescent
Psychiatry), 36:21-37:1, 38:6-10, 41:20-42:6 (Sept. 12, 2023); Dr.
Helen Hughes (John Hopkins Medicine) 69:3-10 (Sept. 12, 2023); Jodi
Sullivan (Investigations Medicare Drug Integrity Contractor), 197:5-
13, 197:24-198:21 (Sept. 12, 2023); and Dr. Jeffrey Chester, 256:22-
257:10 (Sept. 12, 2023); Telemedicine Listening Sessions, Dr.
Felicia Bailey, 19:6-13 (Sept. 13, 2023); Dr. Connie Guille (Medical
University of South Carolina), 52:11-20 (Sept. 13, 2023); Christa
Natoli (CTel), 151:15-152:3 (Sept. 13, 2023); John Wells (Louisiana
State University), 160:4-8 (Sept. 13, 2023); Dan Golden (East Coast
Telepsychiatry), 215:6-216:23 (Sept. 13, 2023); Dr. Shirley Reddoch,
235:14-18 (Sept. 13, 2023); Dr. Stephen Martin (Boulder Care),
128:24-129:10 (Sept. 13, 2023); and Dr. Ujjal Ramtekkar (Quartet
Health), 142:10-18 (Sept. 13, 2023).
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To address these risks to public health and safety, it is
imperative that clinician special registrants ultimately be required to
perform this comprehensive PDMP check of all 50 states, and any other
U.S. district or territory that maintains its own PDMP. This
comprehensive nationwide PDMP check would provide the clinician special
registrants a comprehensive view of the patient's prescription history,
helping to prevent over-prescribing and mitigating the risk of patients
engaging in ``doctor shopping'' to obtain multiple controlled substance
prescriptions across state lines. DEA acknowledges that it is currently
unlikely that any one healthcare provider has access to all PDMPs
nationwide. However, DEA also recognizes that current efforts to
standardize, centralize, and interconnect PDMP data are making headway.
These initiatives, aimed at creating a more unified and accessible
system, offer a feasible future solution to bridge the gap and improve
the accessibility of vital prescription information.
Special Registration Prescriptions and Audio-Video
Telecommunication Systems. Proposed 21 CFR 1306.44(a) mandates that a
clinician special registrant utilize both audio and video components of
an audio-video telecommunications system to prescribe under the Special
Registration framework for every telemedicine encounter whether an
initial visit or subsequent visit or follow-up. This requirement
underscores the critical need to not only audibly, but visually, assess
patients when prescribing controlled substances. Controlled substances,
which often carry a substantial risk of misuse or diversion, require a
more comprehensive evaluation. Visual observation of the patient is
crucial for providers, because it communicates valuable information
that cannot be obtained through other means and allows for more
effective identity verification.\71\ By observing a
[[Page 6555]]
patient's physical appearance, demeanor, and body language, providers
can gather important indications of misuse or diversion of controlled
substances. Though DEA has permitted audio-only telemedicine on a
temporary basis for patients during and immediately after the COVID-19
PHE, the current landscape calls for a reevaluation. The Department of
Health and Human Services (HHS) declared an end to the Federal PHE for
COVID-19 under section 319 of the Public Health Service Act on May 11,
2023,\72\ and as pointed out by some researchers, the ``risk benefit
calculation of audio-only visits has changed, and it is increasingly
important to protect patients from potentially lower-quality audio-only
visits,'' especially when visual observations are critical.\73\ At the
Telemedicine Listening Sessions, various speakers advocated for the use
of audio-video telemedicine specifically.\74\ Expressing their concerns
about the use of audio-only telemedicine, one speaker said, ``we
require video visits. On rare occasions we do the telephone. Just for
the fact you can lay eyes on the people. They may tell you they're
perfectly fine, but they may have tears coming down their face. They
may have physical problems. They may have meth marks. You know, things
that people need to see. So video's important.'' \75\
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\71\ See Faustinella F. The Power of Observation in Clinical
Medicine. Int J Med Educ. 2020 Nov 30;11:250-251. doi: 10.5116/
ijme.5fb9.1c9b. PMID: 33254147; PMCID: PMC7883801 (Available:
<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7883801/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7883801/</a>); and
Bramstedt, Katrina, Ph.D., MA. The Use of Visual Arts as a Window to
Diagnosing Medical Pathologies. AMA J Ethics. 2016;18(8):843-854.
doi: 10.1001/journalofethics.2016.18.8.imhl1-1608 (Available:
<a href="https://journalofethics.ama-assn.org/article/use-visual-arts-window-diagnosing-medical-pathologies/2016-08">https://journalofethics.ama-assn.org/article/use-visual-arts-window-diagnosing-medical-pathologies/2016-08</a>).
\72\ Fact Sheet: End of the COVID-19 Public Health Emergency,
Press Release, U.S. Dept. of Health and Human Services (HHS)(May 9,
2023), <a href="https://www.hhs.gov/about/news/2023/05/09/fact-sheet-end-of-the-covid-19-public-health-emergency.html">https://www.hhs.gov/about/news/2023/05/09/fact-sheet-end-of-the-covid-19-public-health-emergency.html</a>.
\73\ Rethinking the Impact of Audio-Only Visits on Health
Equity, RAND Corp. (Dec. 17, 2021),), <a href="https://www.rand.org/blog/2021/12/rethinking-the-impact-of-audio-only-visits-on-health.html">https://www.rand.org/blog/2021/12/rethinking-the-impact-of-audio-only-visits-on-health.html</a>.
\74\ Telemedicine Listening Sessions, Melanie Melville (Legacy
Community Health), 96:1-16 (Sept. 12, 2023); Bruce Bassi, M.D.,
29:18-30:3 (Sept. 13, 2023); Connie Guille (Medical University of
South Carolina), M.D., 53:21-54:1 (Sept. 13, 2023).
\75\ Telemedicine Listening Sessions, Dan Golden, 218:15-219:6
(Sept. 13, 2023).
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The utilization of audio-video telecommunication systems--as
opposed to audio-only communication technology--not only offers
advantages in helping prevent diversion, but it also allows the
clinician special registrant to visually confirm the patient's identity
in real time. This would be achieved by comparing the patient to their
existing photo identification on file, which will exist in the vast
majority of cases given the requirements under proposed 21 CFR
1304.04(i). This direct visual verification serves as a further
safeguard against the diversion of controlled substances during
telemedicine encounters.\76\
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\76\ See Telemedicine Listening Sessions, Kevin Duane. 202:21-
203:9 (Sept. 12, 2023); and Bruce Bassi, M.D., 31:12-20 (Sept. 13,
2023).
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Schedule III-V Special Registration Prescriptions for Opioid Use
Disorder. Proposed 21 CFR 1306.44(b) would allow clinician special
registrants to issue special registration prescriptions for, and
platform special registrants to dispense, Schedule III-V controlled
substances approved by the FDA for the treatment of Opioid Use Disorder
(``OUD'') through the use of an audio-only telecommunications system as
described in 42 CFR 410.78(a)(3), provided that the treatment was
initiated through the use of an audio-video telecommunications system
as defined in the proposed 1300.04 of this chapter. According to one
survey of 866 mental health (MH), primary care (PC), and specialty care
(SC) clinicians in the Department of Veterans Affairs New England
Healthcare System (VANEHS), less than one-third of the clinicians
surveyed rated phone as equivalent to or higher in quality when
treating new patients. However, the survey indicated that support for
such audio-only telecommunications increased significantly when
treating established patients. These results highlight the importance
of visual assessments for new patients, while showing that audio-only
telecommunications may be more acceptable or useful once a patient is
established.\77\
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\77\ Connolly SL, Miller CJ, Gifford AL, Charness ME.
Perceptions and Use of Telehealth Among Mental Health, Primary, and
Specialty Care Clinicians During the COVID-19 Pandemic. JAMA Netw
Open. 2022;5(6):e2216401. doi:10.1001/jamanetworkopen.2022.16401.
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Currently, the only Schedule III-V narcotic drug approved by the
FDA for the treatment of OUD is buprenorphine.\78\ DEA's proposed
authorization for the use of audio-only telecommunications systems for
the treatment of OUD is rooted in the unique nature of OUD treatment.
The complex and long-term management of OUD often necessitates a
continuum of care that might be best accommodated through flexibility
in telecommunication methods. Expanding the circumstances under which
clinician practitioners are authorized to prescribe buprenorphine via
telemedicine encounters, including audio-only encounters, would
increase access to treatment for those individuals with OUD who may not
want to seek treatment, or are unable to seek treatment, due to various
economic, geographical, sociological, and logistical reasons.
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\78\ 42 CFR 8.12(h)(2)(ii).
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Many OUD patients may lack the financial means to obtain in-person
treatment traditionally or through audio-video telemedicine encounters.
OUD patients who are unhoused, unemployed, or facing other challenges
may find it prohibitive to afford devices capable of audio-video
telemedicine encounters or consistent access to wireless internet and/
or data plans adequate to support bandwidth demands of telemedicine
encounters.\79\ The estimated number of deaths from opioid overdoses
for the 12-month period ending in October 2023 were 79,695, with a peak
of 83,985 opioid overdose deaths for the 12-month period ending in May
2023.\80\ Access to buprenorphine decreases the risk of overdosing,\81\
and increasing access to buprenorphine after a drug overdose has also
been associated with a reduced risk of death.\82\ This allowance
acknowledges the specific challenges faced by OUD patients and the
importance of ensuring consistent therapeutic relationships with
limited interruptions.
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\79\ DeLaCruz et al., Telemental Health for the Homeless
Population: Lessons Learned when Leveraging Care, (Dec. 8, 2022)
<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9734763/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9734763/</a>.
\80\ Provisional Drug Overdose Death Counts, National Center for
Health Statistics, Centers for Disease Control and Prevention.
<a href="https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm">https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm</a>. Updated
March 3, 2024. Last accessed April 12, 2024.
\81\ Dadiomov, et al., Buprenorphine and naloxone access in
pharmacies within high overdose areas of Los Angeles during the
COVID-19 pandemic, Harm Reduction Journal (June 29, 2022), <a href="https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-022-00651-3">https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-022-00651-3</a>. Last accessed April 11, 2024.
\82\ Larochelle, et al., Medication for Opioid Use Disorder
After Nonfatal Opioid Overdose and Association with Mortality,
Annals of Internal Medicine, (August 07, 2018), <a href="https://www.acpjournals.org/doi/10.7326/M17-3107">https://www.acpjournals.org/doi/10.7326/M17-3107</a>. Last accessed April 11,
2024.
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It also important to highlight that the Expansion of Buprenorphine
Treatment via Telemedicine Encounter final rule (RIN 1117-AB78),
jointly promulgated with HHS elsewhere in this issue of the Federal
Register, allows a DEA-registered practitioner without a Special
Registration to issue a prescription for a Schedule III-V controlled
substance approved by the FDA for the treatment of OUD via audio-only
or audio-video telemedicine for an initial consecutive six-month
supply. Following the initial six-month supply, practitioners may
prescribe the controlled substance by other forms of the practice of
telemedicine authorized under the CSA (such as pursuant to a Special
[[Page 6556]]
Registration) or after conducting an in-person medical evaluation.
This proposed Special Registration NPRM would not preclude a
clinician special registrant from utilizing the authority under the
Expansion of Buprenorphine Treatment via Telemedicine Encounter final
rule (RIN 1117-AB78) for the prescription of buprenorphine for the
treatment of OUD. However, after the six-month supply has been
completed, a clinician special registrant would need to initiate
further prescribing of the controlled substance through an audio-video
telecommunications system. After this initial audio-video telemedicine
encounter, the clinician special registrant may then use audio-only
telecommunications systems to prescribe buprenorphine for the treatment
of OUD to the patient for the duration of the practitioner-patient
relationship.
DEA's proposed authorization of audio-only telemedicine follow-ups
under the Special Registration framework does not or should not be
taken to imply that buprenorphine cannot be or is not diverted. Some
presenters spoke to these issues during the Telemedicine Listening
Sessions. According to one presentation, there is a ``robust illicit
market for buprenorphine,'' and anecdotal reports of patients are
selling buprenorphine to fund abuse of other controlled substances.\83\
Another presenter said that drugs like suboxone and buprenorphine,
prescribed to treat OUD, are used as a ``currency'' to purchase other
drugs like methamphetamines, and that in his community, ``if
methamphetamine is involved, you can pretty much be assured the
diversion of buprenorphine is involved.'' \84\
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\83\ Telemedicine Listening Sessions, Daniel Reck (Matclinics),
104:3-9. (Sept. 12, 2023).
\84\ Telemedicine Listening Sessions, Jerome Cohan (Catalyst
Health Solutions), 268:2-20. (Sept. 12, 2023).
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Such anecdotal information, however, must be considered in the
context of the nation's opioid crisis, as well as recent data showing a
lower risk of diversion for buprenorphine relative to other controlled
substances. In November 2023, a report by the Office of the Inspector
General of HHS found that 97 percent of Part D enrollees received the
recommended amounts or less of buprenorphine for OUD in 2022,
suggesting that the risk of misuse or diversion of buprenorphine in
Medicare Part D may be low.\85\ Considering this data and the
additional proposed safeguards in this rule for special registration
prescriptions, including the initiation of buprenorphine through audio-
video telemedicine encounters, DEA believes that expanding access to
buprenorphine through audio-only follow-ups outweighs the relatively
lower risk of misuse and diversion of buprenorphine.
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\85\ U.S. Dept. of Health and Human Services, Office of
Inspector General, OEI-02-24-00130, Data in Brief: The Risk of
Misuse and Diversion of Buprenorphine for Opioid Use Disorder in
Medicare Part D Continues to Appear Low: 2022 (Nov. 2023)
(Available: <a href="https://oig.hhs.gov/oei/reports/OEI-02-24-00130.pdf">https://oig.hhs.gov/oei/reports/OEI-02-24-00130.pdf</a>).
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Schedule II Controlled Substance Prescriptions. Proposed 21 CFR
1306.45 requires that every special registration prescription for a
Schedule II controlled substance be issued by a clinician special
registrant that maintains the Advanced Telemedicine Prescribing
Registration, who is issuing the prescription while the clinician
special registrant is practicing within their given medical specialty.
Proposed 21 CFR 1306.45(a) imposes further conditions on clinician
special registrants who are pediatricians or board-certified in
pediatric care and requires the mandatory presence of the minor's
parent or guardian when the clinician special registrant prescribes a
Schedule II controlled substance to the minor. This proposed provision
is rooted in DEA's commitment to safeguarding the well-being of minors,
particularly given the substantial risks associated with Schedule II
controlled substances, including opioids.
This safeguard aligns with the broader intent of the Ryan Haight
Act, which was enacted following the death of Ryan Haight, who
tragically died after obtaining prescription opioids online without a
valid prescription and without having ever been seen by the prescribing
physician. Ryan Haight was only 17 years old when he purchased the
opioids, and 18 years old when he died.\86\ The direct parental or
guardian supervision would help to discourage any potential misuse or
attempts to acquire a Schedule II controlled substance for non-medical
reasons. While DEA acknowledges potential concerns of minors who may
perceive this as an intrusion on their privacy, it is crucial to
balance this consideration against the inherent risks associated with
Schedule II controlled substances in particular. It should also be
noted that this proposed requirement would not extend to cases where a
pediatrician prescribes a Schedule III through V controlled substance
under the Special Registration framework.
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\86\ U.S. Drug Enforcement Administration, Prescription for
Disaster: How Teens Abuse Medicine (Accessed: Dec. 13, 2023)
(Available: <a href="https://www.dea.gov/sites/default/files/resource-center/Publications/DEA_Prescription-For-Disaster_508ver.pdf">https://www.dea.gov/sites/default/files/resource-center/Publications/DEA_Prescription-For-Disaster_508ver.pdf</a>).
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Given the higher potential for abuse and dependence of Schedule II
controlled substances, 21 CFR 1306.45 proposes two additional
requirements when issuing a special registration prescription for a
Schedule II controlled substance; DEA anticipates imposing one or both
of the proposed requirements based on the comments received by
stakeholders. The first of the two proposed requirements, under
proposed 21 CFR 1306.45(b), would require that the clinician special
registrant be physically located in the same state as the patient when
issuing a special registration prescription for a Schedule II
controlled substance. Under this same-state limitation, when issuing a
Schedule II special registration prescription, a clinician special
registrant would not only have to have the Advanced Telemedicine
Prescribing Registration, and a State Telemedicine Registration in the
state in which the patient is located, but the clinician special
registrant would also have to be physically located in the same state
as the patient.\87\ Requiring the clinician special registrant to be in
the same state as the patient helps mitigate the risks associated with
the prescribing of Schedule II controlled substances across state
lines. Geographical proximity enables more effective oversight by state
regulatory agencies to ensure compliance with state laws governing the
prescription of these high-risk medications and will make it more
likely that the clinician special registrant can see the patient in-
person should any medical or diversion concerns arise.
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\87\ It should be noted, however, that the Special Registered
Location associated with the Advanced Telemedicine Prescribing
Registration would not have to be in the same state in which the
patient was issued the Schedule II controlled substance.
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The second of the two proposed requirements, under proposed 21 CFR
1306.45(c), would require that the average number of special
registration prescriptions for Schedule II controlled substances
constitutes less than 50 percent of the total number of Schedule II
prescriptions issued by the clinician special registrant in their
telemedicine and non-telemedicine practice in a calendar month.
Limiting the proportion of Schedule II prescriptions issued through
telemedicine would help to manage the risks associated with the
prescribing of Schedule II controlled substances by ensuring that a
significant portion of these prescriptions are issued following in-
person medical evaluations, which can provide a more comprehensive
assessment of the
[[Page 6557]]
patient's medical history and condition than can be done remotely.
State Laws Applicable to Special Registration Prescriptions.
Proposed 21 CFR 1306.46 would require special registrants, when issuing
a special registration prescription, to comply with the laws and
regulations of the state in which the special registrant is located
during the telemedicine encounter resulting in the special registration
prescription; the state in which the patient is located during the
telemedicine encounter resulting in the special registration
prescription; and any state or states in which the special registrant
maintains a DEA registration to dispense controlled substances or a
medical license, to the extent that the law or regulation applies to
telemedicine encounters between practitioners and patients located in
the states in which the special registrant and the patient are each
located during the telemedicine encounter resulting in the special
registration prescription. This provision would require that the
practice of telemedicine be conducted in accordance with applicable
state laws set forth in 21 U.S.C. 802(54).
2. Additional Elements on a Special Registration Prescription
A prescription for controlled substances, whether issued via
telemedicine or not, must contain the elements specified in 21 CFR
1306.05(a), which encompass the signature of the prescriber, issue
date, patient's full name and address, drug details (name, strength,
dosage form, and quantity), directions for use, and the practitioner's
name, address, and registration number.\88\ Proposed 21 CFR 1306.47
would require two additional elements for special registration
prescriptions: (1) the Special Registration numbers of the clinician
practitioner and, if a platform practitioner facilitated the
prescription, the platform practitioner; and (2) State Telemedicine
Registration numbers of the clinician practitioner and, if a platform
practitioner facilitated the prescription, the platform practitioner
(unless exempted from obtaining a State Telemedicine Registration under
proposed 21 CFR 1301.11(d)).\89\ Proposed 21 CFR 1306.47(c) would add a
corresponding liability provision for these new requirements, to track
the current provision in 21 CFR 1306.05(f) that imposes a corresponding
liability on a pharmacist who fills a prescription not prepared in the
form prescribed in 21 CFR 1306.05(a).
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\88\ <a href="https://www.fda.gov/drugs/development-approval-process-drugs/national-drug-code-database-background-information">https://www.fda.gov/drugs/development-approval-process-drugs/national-drug-code-database-background-information</a>; <a href="https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory">https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory</a>.
\89\ Proposed 21 CFR 1306.47(b) would not require that the
Special Registrant provide the registration number associated with
their conventional registration under 21 U.S.C. 823(g).
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The inclusion of the Special Registration numbers of the clinician
practitioner and the platform practitioner (if a platform practitioner
facilitated the prescription) would provide the pharmacist the
information necessary to determine whether the clinician practitioner
has the authority to prescribe a Schedule II controlled substance under
the Special Registration framework, and that the platform practitioner
(if a platform practitioner facilitated the prescription) has the
authority to dispense a Schedule II controlled substance. The inclusion
of State Telemedicine Registration numbers would provide pharmacists
the information necessary to verify that patients are only being
prescribed special registration prescriptions by special registrants
authorized to practice in the specific state where the patient is
located; registered pharmacists would be able to verify these
registration numbers on DEA's CSA Registration Validation Tool.
Pharmacists occasionally encounter what they may perceive as ``red
flags'' for certain telemedicine prescriptions, which can stem from the
nature of telemedicine itself, where patients may receive prescriptions
from prescribers located at distances far away (both inside and outside
the state where the patient is located). The geographical distance can
raise doubts about the legitimacy of the prescription and could lead
pharmacists to question its validity and refuse to fill the
prescription. By verifying the State Telemedicine Registration numbers,
pharmacists would be provided a level of assurance that a special
registration prescription is legitimate when it originates from a
prescriber located a significant distance from the patient. For
clinician special registrants exempted from obtaining State
Telemedicine Registrations, proposed 21 CFR 1306.47(a) would require
them to instead provide a notation on the prescription identifying the
state in which the patient is located.
C. Recordkeeping and Reporting Under 21 CFR Part 1304
Clinician special registrants would remain subject to their
existing recordkeeping and reporting obligations under their 21 U.S.C.
823(g) registrations; however, they would also be subject to
supplementary requirements within the Special Registration framework.
Clinician special registrants would be required to establish and
maintain photographic records for patient verification and maintain
their special registration prescription records at their designated
special registered location. Platform special registrants, on the other
hand, would be required to maintain and update credential verification
and documentation records. As to data reported to DEA, pharmacies
dispensing special registration prescriptions would be required to
report monthly aggregated special registration prescription data on
Schedule II controlled substances and certain Schedule III-V controlled
substances, and special registrants would be required to report
annually aggregated information about their telemedicine practice,
including the number of new patients they treat through telemedicine,
and the total number of special registration prescriptions for Schedule
II controlled substances, and certain Schedule III-V controlled
substances, they dispensed for the preceding year.
1. Patient Verification Photographic Record
Proposed 21 CFR 1304.04(i) would generally require that a clinician
special registrant, or a delegated employee or contractor under the
direct supervision of the clinician special registrant, verify the
identity of a patient seeking treatment via telemedicine by requiring
that the patient present a state or federal government-issued photo
identification card through the camera of the audio-video
telecommunications system. At the first telemedicine encounter, the
clinician special registrant would also be required to capture a
photographic record of the patient presenting their federal or state-
issued photo identification card or other acceptable documents and use
the photographic records to confirm the patient's identity in
subsequent telemedicine encounters.
If for some reason the patient does not consent to their photo
being captured, proposed 21 CFR 1304.04 would allow the clinician
special registrant (or their delegated employee or contractor under
their direct supervision) to accept a copy of the patient's federal or
state government-issued photo identification card or other forms of
documentation provided by the patient. To ensure that patient privacy
is protected, the patient verification photographic records would be
securely stored in the patient's medical record or chart, separate from
the special registration prescription records/data reported to DEA
under proposed 21 CFR 1304.40.
Recognizing that not all persons may have a photo identification
card,
[[Page 6558]]
proposed 21 CFR 1304.04(i)(1) would allow a clinician special
registrant, or a delegated employee or contractor under the direct
supervision of the clinician special registrant, to verify the identity
of the patient with other forms of documentation, and would require the
clinician special registrant to maintain a record of how they verified
the patient's identity and what documents were used to verify the
patient's identity. For example, a clinician special registrant (or
their delegated employee or contractor under their direct supervision)
might verify patient identity by observing a patient's pay stub and/or
a bill with the patient's home address, a letter provided by a shelter
employee if the patient is unhoused, or a patient's school
identification card or report card if the patient is a minor.
This proposed requirement would ensure that the patient's identity
is verified at each telemedicine encounter, reducing the risk of
unauthorized individuals diverting controlled substances. Throughout
the Telemedicine Listening Sessions, various presenters underscored the
importance of implementing strong patient identification measures in
the context of telemedicine.\90\ According to some physicians who
presented during the Telemedicine Listening Sessions, identity
verification of telemedicine patients is currently a typical practice
and constitutes a component of good care.\91\ Furthermore, the
photographic record provides a clear link between the patient's
identity and the telemedicine encounter, supporting accurate
recordkeeping under the Special Registration framework.\92\
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\90\ Telemedicine Listening Sessions: Lori Uscher-Pines (RAND
Corporation), 131:15-19 (Sept. 12, 2023); Bruce Bassi, M.D., 29:18-
30:3 (Sept. 13, 2023); Dr. Phillip Moore (Gaudenzia), 85:10-16,
86:14-87:8 (Sept. 13, 2023); and Dan Golden (East Coast
Telepsychiatry), 218:9-14 (Sept. 13, 2023).
\91\ Telemedicine Listening Sessions: Dr. Shabana Khan (American
Psychiatric Association and American Academy of Child and Adolescent
Psychiatry), 33:20-34:5, 43:9-19 (Sept. 12, 2023); Dr. Brian Clear
(Bicycle Health), 77:13-22 (Sept. 12, 2023); Telemedicine Listening
Sessions: Lori Uscher-Pines (RAND Corporation), 131:15-19 (Sept. 12,
2023); Bruce Bassi, M.D., 29:18-30:3 (Sept. 13, 2023); Dr. Phillip
Moore (Gaudenzia), 85:10-16, 86:14-87:8 (Sept. 13, 2023); and Dan
Golden (East Coast Telepsychiatry), 218:9-14 (Sept. 13, 2023).
\92\ See Telemedicine Listening Sessions, Bruce Bassi, M.D.,
31:12-20 (Sept. 13, 2023).
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2. Special Registration Telemedicine Encounter Record
For every telemedicine encounter resulting in a special
registration prescription, proposed 21 CFR 1304.04(j) would require
that clinician special registrants maintain a record of the date and
time of the telemedicine encounter, the address of the patient during
the telemedicine encounter, and the home address of the patient. Like
patient verification photographic records, the clinician special
registrant would be required to maintain Special Registration
telemedicine encounter records for a minimum of two (2) years from the
date of the telemedicine encounter. The proposed Special Registration
telemedicine encounter record provides an additional layer of
verification for the telemedicine encounter, detailed documentation
that can be referenced by the clinician special registrant in the
future and helps ensure that the patient is located in a state in which
the clinician special registrant is authorized to prescribe controlled
substances under the proposed Special Registration framework.
3. Credential Verification and Conduct-Related Documentation
Proposed 21 CFR 1304.04(k) would require platform special
registrants to maintain records related to clinician special
registrants with whom they enter and maintain a covered platform
relationship, including: \93\ (1) verification of the clinician special
registrant credentials, including but not limited to records on
education, training, board or specialty certifications, and their
Special Registration number and State Telemedicine Registration
number(s); (2) the employment contract and any other contract between
the platform special registrant and the clinician special registrant;
and (3) any disciplinary actions or sanctions, or documentation of
complaints, disputes, or incidents involving the practice of
telemedicine. The platform special registrant would be required to
maintain and update the credential verification and conduct-related
records for a minimum of every two (2) years, which should be readily
available for inspection by DEA.
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\93\ Proposed 21 CFR 1300.04 would define a covered platform
relationship to mean ``the formal association between the online
telemedicine platform, in its capacity as a platform practitioner,
and the clinician practitioner it directly employs, contracts with,
or is otherwise professionally affiliated with to introduce or
facilitate connections between patients seeking remote medical
consultations and the clinician practitioner, via an audio-video
telecommunications system, for the diagnosis, treatment, and
prescription of controlled substances.''
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This proposed requirement is intended to address DEA's concerns
regarding the adequacy of the screening of the prescribers utilizing
the services of the covered online telemedicine platforms as discussed
above. By mandating the verification and documentation of clinician
registrants' qualifications and credentials, these records should serve
as evidence of thorough screening processes by the platform special
registrants, helping to ensure that only qualified and vetted clinician
practitioners are practicing telemedicine under the Special
Registration framework and reducing the risk of improper remote
prescribing of controlled substances. Furthermore, by requiring that
platform special registrants maintain such records, they are compelled
to assume responsibility for the conduct and prescribing practices of
the clinician special registrants whose telemedicine prescribing is
facilitated by their platform.
4. Centralized Recordkeeping at the Special Registered Location
Proposed 21 CFR 1304.04(l) mandates that records arising from
telemedicine encounters under the Special Registration framework be
kept at the special registered location. Given the nationwide reach of
telemedicine--where a special registrant could serve patients in any
state--it would pose an unreasonable administrative burden to require
the special registrant to maintain records in every state where
telemedicine patients are located. By consolidating these records, DEA
investigations are more efficient, enhancing the detection of diversion
patterns, which is vital for preventing the diversion and misuse of
controlled substances. This approach enhances public safety while
ensuring a practical burden for practitioners. Furthermore, this
proposed regulation keeps pace with modern recordkeeping practices, as
the majority of healthcare providers already maintain electronic
records, which can be easily centralized and accessed when required.
5. Pharmacy Reporting of Special Registration Prescription Data
Proposed 21 CFR 1304.60 would require that a pharmacy report
aggregate data, within the first seven (7) days of the start of every
month, for the special registration prescriptions filled during the
preceding month for each Schedule II controlled substance and certain
Schedule III-V controlled substances, including Ketamine, Tramadol, and
any depressants that constitute a benzodiazepine (including their
salts, isomers, and salt of isomers).\94\ For each
[[Page 6559]]
of these controlled substances, the pharmacy would provide the
following information, organized by the different State Telemedicine
Registration numbers of the individual special registrants who
prescribed the controlled substance, and organized by the National Drug
Code (NDC) for each formulation of the controlled substance dispensed:
the number of prescriptions filled, the volume of the controlled
substance dispensed, and the number of patients prescribed the
controlled substance. A NDC is a unique, 10-digit three-segment number
that serves as a universal product identifier for human drugs,
including controlled substances. It is used by drug establishments,
such as manufacturers and distributors, to report all drugs made,
prepared, propagated, compounded or processed for sale in the U.S. to
the Food and Drug Administration (FDA).\95\ At this time, Schedule III-
V controlled substances subject to this proposed requirement under 21
CFR 1304.60 are limited to those specifically identified. However,
additional Schedule III-V controlled substances may be included in the
future via regulation based on trends in diversion and misuse.
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\94\ DEA has identified 36 depressants that constitute a
benzodiazepine Scheduled in 21 CFR 1308.14(c) at the time of this
publication.
\95\ National Drug Code Directory, U.S. Food & Drug
Administration (FDA) (July 22,2022) (<a href="https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory">https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory</a>).
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Requiring timely collection and reporting of aggregate patient-
anonymized prescription data ensures that DEA has current information
on the prescribing of controlled substances via telemedicine, vital for
protecting public health and safety, especially amid the national
opioid overdose epidemic. Following the COVID-19 PHE, the opioid
overdose epidemic has only worsened. According to the Centers for
Disease Control and Prevention (CDC), the ``number of people who died
from a drug overdose in 2021 was over six times the number in 1999. The
number of drug overdose deaths increased more than 16% from 2020 to
2021. Over 75% of the nearly 107,000 drug overdose deaths in 2021
involved an opioid.'' \96\
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\96\ Understanding the Opioid Overdose Epidemic, Centers for
Disease Control and Prevention (CDC) (Aug. 8, 2023), <a href="https://www.cdc.gov/opioids/basics/epidemic.html">https://www.cdc.gov/opioids/basics/epidemic.html</a>.
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While the opioid overdose epidemic has, in recent years, been
largely fueled by illicitly manufactured fentanyl, a synthetic opioid,
the diversion of prescribed opioids exacerbates the opioid crisis by
increasing the overall opioid supply available on the illicit market.
Proposed 21 CFR 1304.60 would arm DEA with the data necessary to timely
intervene in cases of diversion or other acts in violation of the law.
Recognizing the importance of data to combat diversion, various
stakeholders speaking at the Telemedicine Listening Sessions--many of
whom were practitioners--advocated for DEA to collect prescription data
to help identify potential exploitative practices.\97\ One physician
said, ``I urge DEA to design any new process to improve [its] ability
to oversee and audit prescribing patterns and to intervene when
exploitative practice is identified. . . .'' \98\
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\97\ Telemedicine Listening Sessions, Robert Krayn (Talkiatry),
26:4-21 (Sept. 12, 2023); Dr. Shabana Khan (American Psychiatric
Association and American Academy of Child and Adolescent
Psychiatry), 37:2-11 (Sept. 12, 2023); Dr. Brian Clear (Bicycle
Health), 79:8-13, 87:3-8 (Sept. 12, 2023); Chris Adamec (Alliance
for Connected Care), 143-18-144:11, 146:5-8 (Sept. 12, 2023); Kevin
Duane, PharmD, 207:3-9, 213:13-214:9 (Sept. 12, 2023); Felicia Baily
(Nurse Practitioner, Avaesen Healthcare), 17:25-18:21 (Sept. 13,
2023); and John Heaphy (New York Dept. of Health), 78:25-79:6 (Sept.
13, 2023).
\98\ Telemedicine Listening Sessions, Dr. Brian Clear (Bicycle
Health), 79:8-13 (Sept. 12, 2023).
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The aggregation of prescription data would also allow DEA to employ
advanced data analytics to further combat diversion. With such data,
for example, DEA could detect outliers, irregular prescription volumes,
and abnormal geographic concentrations of controlled substances. As
identified by the Government Accountability Office (GAO) in its 2020
recommendations to DEA, which encouraged the enhanced utilization of
data analytics to identify problematic patterns and trends to combat
the opioid epidemic, ``data-analytics activities can include a variety
of techniques to prevent and detect diversion, including data matching
and data mining. Data matching is the largescale comparison of records
and files to detect errors or incorrect information. It can be used to
verify information provided by recipients or detect unreported changes.
Data mining is the use of automated computer algorithms to detect
patterns, including those that are otherwise not obvious, correlations,
or anomalies within large data sets indicative of potential
diversion.'' \99\ At the Telemedicine Listening Sessions, similar
recommendations to those of the GAO were echoed.\100\ Various
stakeholders advocated for the leveraging of data analytics as a tool
to be used by DEA to address bad actors or exploitative practices.\101\
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\99\ Drug Control: Actions Needed to Ensure Usefulness of Data
on Suspicious Opioid Orders, U.S. Gen. Accounting Office, GAO-20-
118, (Jan. 29, 2020),), <a href="https://www.gao.gov/products/gao-20-118#summary_recommend">https://www.gao.gov/products/gao-20-118#summary_recommend</a>.
\100\ Telemedicine Listening Sessions, Dr. Shabana Khan
(American Psychiatric Association and American Academy of Child and
Adolescent Psychiatry), 37:18-23 (Sept. 12, 2023); Dr. Brian Clear
(Bicycle Health), 79:8-13 (Sept. 12, 2023); and Laura Jantos
(Healthcare Technology and Digital Healthcare Management
Consultant), 14:25-15:21 (Sept. 13, 2023).
\101\ Id.
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Data analytics could help recognize patterns in how controlled
substances are combined to provide DEA with critical information about
emerging trends in polysubstance abuse.\102\ Recent examples highlight
the dangers of such combinations, underscoring the need for proactive
measures. Benzodiazepines, Schedule IV depressants, have been used to
amplify the effect of opioids, especially when injected.\103\ The
combination of opioids and benzodiazepines can have dire consequences,
as their use together increases the risk of overdose as both drugs
cause sedation and suppress breathing.\104\ According to one study,
overdose death rates among patients taking both drugs was 10 times
higher than among those only receiving opioids.\105\ By staying
informed about emerging drug use trends, particularly polysubstance
abuse, DEA can take proactive measures to prevent these trends from
evolving into widespread problems. This information not only aids in
prevention but could also guide DEA in strategically directing
resources and investigative efforts to ensure the most effective
responses to emerging challenges.
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\102\ Centers for Disease Control and Prevention (CDC). What is
Polysubstance Use? (February 23, 2022) (Available: <a href="https://www.cdc.gov/stopoverdose/polysubstance-use/index.html">https://www.cdc.gov/stopoverdose/polysubstance-use/index.html</a>).
\103\ Jones JD, Mogali S, Comer SD. Polydrug abuse: a review of
opioid and benzodiazepine combination use. Drug Alcohol Depend. 2012
Sep 1;125(1-2):8-18. doi: 10.1016/j.drugalcdep.2012.07.004. Epub
2012 Aug 2. PMID: 22857878; PMCID: PMC3454351 (Available: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3454351/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3454351/</a>).
\104\ National Institute on Drug Abuse (NIDA). Benzodiazepines
and Opioids. (November 7, 2022), Available: <a href="https://nida.nih.gov/research-topics/opioids/benzodiazepines-opioids">https://nida.nih.gov/research-topics/opioids/benzodiazepines-opioids</a>.
\105\ Dasgupta N, Funk MJ, Proescholdbell S, Hirsch A, Ribisl
KM, Marshall S. Cohort Study of the Impact of High-Dose Opioid
Analgesics on Overdose Mortality. Pain Med. 2016 Jan;17(1):85-98.
doi: 10.1111/pme.12907. Erratum in: Pain Med. 2016 Apr;17(4):797-8.
PMID: 26333030, <a href="https://pubmed.ncbi.nlm.nih.gov/26333030/">https://pubmed.ncbi.nlm.nih.gov/26333030/</a>).
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Lastly, DEA could use the aggregated data to make more informed,
evidence-based policy decisions. For instance, DEA could timely monitor
controlled substance prescription patterns and demand indicators to
make informed quota decisions to prevent or mitigate shortages and
ensure a steady and reliable supply of controlled substances for
legitimate medical purposes. The data could also be used to better
retrospectively assess the impact of DEA's policy positions and
promulgated
[[Page 6560]]
regulations.\106\ For example, DEA could use the prescription data to
evaluate: patient outcomes associated with special registration
prescriptions; the impact of the proposed Special Registration
regulations on patient access to controlled substances (especially in
remote or rural areas); the efficacy of the proposed Special
Registration regulations on preventing and detecting diversion
associated with remote prescribing; and trends or changes to
telemedicine prescription practices that might necessitate regulatory
reforms.
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\106\ See Administrative Conference of the United States (ACUS),
Administrative Conference Recommendation 2021-2: Periodic
Retrospective Review (June 17, 2021) (Available: <a href="https://www.acus.gov/document/periodic-retrospective-review">https://www.acus.gov/document/periodic-retrospective-review</a>).
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It should be emphasized that the prescription data reporting would
be aggregated and patient-anonymized, and will not be shared with
persons or entities outside of DEA. Like all data provided to, and
handled by, DEA, the security and privacy of such data will be handled
with the highest standards of security and privacy. All data
transmitted to and stored by DEA is encrypted, including data
transmitted between external systems and internal databases.
Furthermore, all data transmitted from registrants to DEA is
additionally protected by Department of Justice firewalls and network
monitoring. Access to the data is limited to certain authorized
persons, employed or contracted by DEA. External user access to
applications receiving and providing data require a unique username and
a strong, complex password, internal users of the data are vetted by
DEA and its Diversion Control Division's security and privacy
processes, and access is restricted according to a need-to-know-basis.
6. Annual Special Registrant Reporting of Special Registration
Prescription Data
Proposed 21 CFR 1304.61 would require that individual special
registrants and platform special registrants report annual data on the
total number of new patients in each state for which they issued at
least one special registration prescription for a Schedule II
controlled substance or certain Schedule III-V controlled substances,
including Ketamine, Tramadol, and any depressant constituting a
benzodiazepine; the total number of special registration prescriptions
for Schedule II controlled substances issued by the special registrant,
in aggregate and across all states; and the total number of special
registration prescriptions for certain Schedule III-V controlled
substances, including Ketamine, Tramadol, and any depressant
constituting a benzodiazepines (including their salts, isomers, and
salt of isomers), which were issued by the special registrant, in
aggregate and across all states.
This proposed reporting requirement would provide DEA with
necessary data to proactively monitor for concerning trends that may
signal the existence of digital pill mills exploiting the proposed
special registration framework to provide patients with medically
unnecessary controlled substances.\107\ Data on new patients and
distribution of Schedule IIs and certain Schedule III-V controlled
substances on an annual basis would allow DEA to assess prescribing
behaviors of controlled substances, identify spikes and anomalies in
prescription volume, and take timely action against suspicious
activity. At this time, Schedule III-V controlled substances subject to
this proposed requirement under 21 CFR 1304.61 are limited to those
specifically identified. However, additional Schedule III-V controlled
substances may be included in the future via regulation based on trends
in diversion and misuse.
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\107\ Stevens, Morgan. Click Here for Adderall: Fixing
Telehealth Advertising and Services to Prevent Stimulant Misuse,
Center for Data Innovation (Dec. 5, 2022), <a href="https://www2.datainnovation.org/2022-telehealth-stimulant-abuse.pdf">https://www2.datainnovation.org/2022-telehealth-stimulant-abuse.pdf</a>.
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D. Regulatory Definitions Under 21 CFR part 1300
This last section provides an overview of proposed regulatory
definitions and revisions to 21 CFR part 1300. These proposed
definitions are intended to provide clarity as to the authorities and
obligations of special registrants under the registration requirements
(21 CFR 1301), prescription requirements (21 CFR 1306), and the
recordkeeping and reporting requirements (21 CFR 1304). The proposed
amendments offer definitions for the different, relevant registrations
under the Special Registration framework, including the: Telemedicine
Prescribing Registration, Advanced Telemedicine Prescribing
Registration, Telemedicine Platform Registration, State Telemedicine
Registration, and special registered location. The core aspects of
these proposed definitions have largely been addressed in the preceding
sections, requiring minimal discussion of many of them here.
That said, the proposed term and definition of a covered online
telemedicine platform warrants further discussion. A covered online
telemedicine platform means an entity that facilitates connections
between patients and clinician practitioners, via an audio-video
telecommunications system, for the diagnosis and treatment of patients
that may result in the prescription of controlled substances, but is
not a hospital, clinic, local in-person medical practice, or insurance
provider, and meets one or more of the following criteria:
(1) the entity explicitly promotes or advertises the prescribing of
controlled substances through the platform;
(2) the entity has financial interests, whether direct incentives
or otherwise, tied to the volume or types of controlled substance
prescriptions issued through the platform, including but not limited
to, ownership interest in pharmacies used to fill patients'
prescriptions, or rebates from those pharmacies;
(3) the entity exerts control or influence on clinical decision-
making processes or prescribing related to controlled substances,
including, but not limited to: prescribing guidelines or protocols for
clinician practitioners employed or contracted by the platform;
consideration of clinician practitioner prescribing rates in the
entity's hiring, retention, or compensation decisions; imposing
explicit or de facto prescribing quotas; directing patients to
preferred pharmacies; and/or
(4) the entity has control or custody of the prescriptions or
medical records of patients who are prescribed controlled substances
through the platform.
When any one of the four factors are present, it solidifies the
platform's role as an integral intermediary in the remote dispensing of
controlled substances. The proposed definition and criteria are
intended to provide a practical and clear framework for identifying
when a DTC online telemedicine platform's conduct qualifies them as a
covered online telemedicine platform, mandating registration as a
dispenser with DEA. As proposed, this definition is intended to limit
the Special Registration requirements only to those DTC online
telemedicine platforms that play a substantial and integral role as
intermediaries in the remote dispensing of controlled substances.
Under the first criterion, when an entity explicitly promotes or
advertises the prescribing of controlled substances through the
platform, it is directly influencing patient behavior and decision-
making. This targeted promotion guides patients to seek medical
consultations and prescriptions for controlled substances through the
platform, effectively influencing the
[[Page 6561]]
demand and supply of this service. This active role in attracting and
managing patient flow makes the platform more involved as an integral
intermediary in the remote prescribing of controlled substances. Under
the second criterion, when an entity has financial interests tied to
the volume or types of controlled substances prescriptions issued
through the platform, the platform's role extends beyond mere
facilitation--it becomes a key player that directly affects the flow
and distribution of controlled substances. The financial ties ensure
that the platform's operations are closely linked to the outcome of
prescription activities, making it an integral intermediary in the
process of remote prescribing of controlled substances.
Under the third criterion, when an entity exerts control or
influence on clinical decision-making processes or prescribing related
to controlled substances, including but not limited to prescribing
guidelines or protocols for clinician practitioners employed or
contracted by the platform, imposing explicit or de facto prescribing
quotas, or directing patients to preferred pharmacies, it plays a
direct and active role in the decision-making processes that affect
patient care and the distribution of controlled substances. The
platform becomes an essential link in the chain between the clinician
practitioner and the patient, making it an integral intermediary in the
process of remote prescribing of controlled substances. Under the
fourth and last criterion, when an entity has control or custody of the
prescriptions or medical records of patients who are prescribed
controlled substances through the platform, it has significant control
over sensitive and regulated information, actively involving the
platform in the handling and processing of controlled substances.
Moreover, control or custody of such information allows a platform to
influence patient treatment plans, underscoring their position as an
intermediary, and thus dispenser, in the process of remote prescribing
of controlled substances.
It is important to clarify that ownership and operation of the
online or digital system or platform on which the virtual visit takes
places are not mandatory criteria within the proposed definition of a
covered online telemedicine platform. Similarly, an entity solely
operating a platform or system that merely provides the technological
service or conduit for a telemedicine encounter to occur, without the
presence of one of the additional four factors, would not constitute a
covered online telemedicine platform. As discussed above, the
definition is also drafted to exclude entities that engage in conduct
that could potentially fall under the definition's criteria but are not
the types of entities whose primary business operations rely on, or
center around, telemedicine services.
The definition of covered online telemedicine platform also
explicitly excludes certain types of entities, including hospitals,
clinics, insurance providers, and local in-person medical practices.
Local in-person medical practice is, in turn, defined by this rule to
be a medical practice where less than 50 percent of the total
prescriptions for controlled substances collectively issued by the
practice's physicians and mid-level practitioners are issued via
telemedicine in any given calendar month, but is not a hospital,
clinic, or insurance provider. The type of entities excluded from the
definition of covered online telemedicine platform are entities that
engage in conduct that could potentially fall under the definition's
criteria but are not the types of entities whose primary business
operations rely on, or center around, telemedicine services.
Determining whether an entity dispenses controlled substances and
meets the criteria of a covered online telemedicine platform is a fact-
specific inquiry. If there is any uncertainty regarding the entity's
role as a dispenser, particularly concerning its involvement in the
practitioner-patient relationship, registering may be advisable to
avert the risk of enforcement action based on potential unregistered,
and thus illegal, dispensing of controlled substances.
Turning elsewhere, DEA is incorporating CMS's current definitions
and standards for the terms hospice care and palliative care.\108\ DEA
acknowledges that its core expertise and mission revolve around
combating the diversion of controlled substances, and therefore is
leveraging the medical expertise of CMS by adopting its healthcare
standards as to these terms. Lastly, the rulemaking rule proposes to
revise the DEA regulatory definition of ``practice of telemedicine'' to
mean practice in accordance with applicable federal and state laws by a
practitioner (other than a pharmacist) who is at a remote location from
the patient and communicates with the patient, or health care
professional who is treating the patient, using a telecommunications
system defined in 42 CFR 410.78(a)(3), which practice falls within a
category specified in the definition.\109\
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\108\ See 42 CFR 418.3.
\109\ Proposed 21 CFR 1300.04. The current regulatory
definition, 21 CFR 1300.04, initially implemented the Ryan Haight
Act's statutory definition by repeating the statutory provision and
requiring the use of a ``telecommunications system referred to in
section 1834(m) of the Social Security Act'' [codified at 42 U.S.C.
1395m(m)].
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E. Request for Comments
With respect to the proposed rule, DEA invites comments regarding
the need for any clarifications or suggested modifications to the
proposed regulations, which are consistent with the public health and
safety. The public's input and insights are instrumental in achieving
the appropriate balance between expanding access to care and
implementing the necessary safeguards to prevent diversion of
controlled substances effectively. In particular, DEA seeks the
public's input on the newly introduced Special Registrations
(Telemedicine Prescribing Registration, Advanced Telemedicine
Prescribing Registration, and Telemedicine Platform Registration), and
the State Telemedicine Registrations. Again, DEA recognizes the broad
nature of the proposed requirements, and highly encourages the public
to provide input on appropriate implementation timelines, or on-ramps
for phased or gradual adoption, to help ensure a smoother transition
when the final rule takes effect. Practitioners, pharmacies, and
industry are encouraged to provide their input on the time necessary to
operationalize the proposed requirements.
Furthermore, DEA is considering the inclusion of a severability
clause in the final rule. Under such a clause, if any specific
provision of the rule is found to be invalid or unenforceable by a
court, the remaining provisions would continue to be operative and
enforceable. We encourage public comments on the inclusion of such a
clause, as well as whether any particular provisions of the proposed
rule are especially integral to its overall implementation. All public
insight, including responsive data, as to the effectiveness or
appropriateness of the proposed safeguards is also encouraged. However,
the public is asked to refrain from commenting on provisions that are
simply republished existing regulatory definitions. These are included
to provide context to the newly proposed definitions and to reduce
editorial resources required for publishing the proposed rule.
[[Page 6562]]
Appendices:
BILLING CODE 4410-09-P
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BILLING CODE 4410-09-C
V. Regulatory Analyses
Executive Orders 12866, 13563, and 14094 (Regulatory Review)
DEA has determined that this rulemaking is a ``significant
regulatory action'' under section 3(f) of Executive Order (E.O.) 12866,
Regulatory Planning and Review and is also a section 3(f)(1)
significant action. Accordingly, this proposed rule has been submitted
to the Office of Management and Budget (OMB) for review. This proposed
rule has been drafted and reviewed in accordance with E.O. 12866,
``Regulatory Planning and Review,'' section 1(b), Principles of
Regulation; E.O. 13563, ``Improving Regulation and Regulatory Review,''
section 1(b), General Principles of Regulation; and E.O. 14094,
``Modernizing Regulatory Review.''
Due to many uncertainties, DEA made a range of estimates: a low
estimate, a moderate (primary) estimate, and a high estimate. Based on
the moderate (primary) estimate, DEA projects that this proposed rule
will result in a total annualized cost of $16 million, a total
annualized cost savings of $23 million, for a net annualized cost
savings of $7 million. The low estimate results in a total annualized
cost of $0.60 million, a total annualized cost savings of $0.85
million, for a net annualized cost savings of $0.25 million. The high
estimate results in a total annualized cost of $86 million, a total
annualized cost savings of $122 million, for a net annualized cost
savings of $36 million. Additionally, the proposed rule is estimated to
increase annualized transfers (registration fees) to the federal
government by $0.90 million, $24 million, and $128 million per year,
for the low, moderate (primary), and high estimates, respectively. Fees
paid to the federal government are considered transfer payments and not
costs.\110\ The full analysis of cost savings, costs, transfers, and
benefits is provided below.
---------------------------------------------------------------------------
\110\ OMB Circular A-4.
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[[Page 6565]]
Overview
I. Regulatory Alternatives Considered
II. Patient Costs, Cost Savings, and Benefits
a. Patient's Cost of Time per Practitioner Visit
b. Patient's Cost of Travel per Practitioner Visit
c. Total Number of Telemedicine Visits
i. Total Number of Telemedicine Visits Under the Current
Telemedicine Rate
ii. Forecasted Total Numbers of Telemedicine Visits
d. Total Patient Cost Savings
e. Patient Benefit: Increased Access to Care
III. Practitioner and Mid-Level Practitioners (``MLP'') Costs, Cost
Savings, and Transfers
A. Number of Conventional Registrations, Special Registrations,
and State Telemedicine Registrations
B. Practitioner and MLP Cost To Apply for Special Registration
C. Practitioner and MLP Cost To Report to DEA
D. Practitioner and MLP Cost To Check PDMP per Visit
E. Practitioner and MLP Total Costs; Cost Savings
F. Practitioner and MLP Transfers
G. Summary of Practitioner Costs, Cost Savings, Benefits, and
Transfers
IV. Pharmacy Costs
V. Healthcare System Costs and Cost Savings
VI. State Costs
VII. Diversion
VIII. Summary of Economic Impact
I. Regulatory Alternatives Considered
DEA considered three alternatives, including the selected
alternative: (1) finalizing the proposed March 2023 General
Telemedicine NPRM and Buprenorphine NPRM; (2) an alternative that would
allow the prescribing of Schedules III-V controlled substances under a
single Special Registration for Telemedicine pursuant to 21 U.S.C.
802(54)(E) and 831(h); and (3) the selected alternative.
First, DEA considered promulgating final rules based on the
proposed March 2023 General Telemedicine NPRM and Buprenorphine NPRM
pursuant to 21 U.S.C. 802(54)(G). The proposed General Telemedicine
NPRM would have allowed for an initial prescription of non-narcotic
Schedules III-V controlled substances for no more than a 30-day supply
in instances where the patient has never had an in-person medical
evaluation, and additional prescriptions beyond the initial 30-day
prescription would require that the patient undergo an in-person
medical evaluation. The proposed General Telemedicine NPRM generally
would have required that a patient undergo an initial in-person medical
evaluation prior to the prescription of Schedule II controlled
substances, and Schedule III-V narcotic controlled substances (with the
exception of buprenorphine for opioid use disorder (``OUD'')
treatment), unless there was a qualifying referral.
Generally, the Buprenorphine NPRM would have allowed practitioners
to prescribe buprenorphine for the induction of OUD treatment for no
more than a 30-day supply through audio-only telemedicine. To obtain an
additional supply of buprenorphine however, the patient would have to
undergo an in-person medical evaluation within 30 days of the induction
of the OUD treatment. Ultimately, DEA determined that final rules of
the proposed regulations would have been potentially too burdensome on
practitioners and patients, leading to reduced access to care.
The second alternative considered by DEA would have allowed
practitioners--irrespective of their medical specialty or the patients
they treat--to prescribe Schedule III-V controlled substances under a
single Special Registration for Telemedicine pursuant to 21 U.S.C.
802(54)(E) and 831(h). Under this alternative, practitioners would not
be authorized to prescribe Schedule II controlled substances. While
this alternative could have established a more streamlined Special
Registration framework, it would not take into consideration the
diverse legitimate needs that practitioners may have to prescribe other
controlled substances through telemedicine based on their medical
specialties or the patients they serve. Additionally, it does not
consider the fact that certain practitioners possess the necessary
qualifications to prescribe Schedule II controlled substances through
telemedicine, despite the heightened risk of abuse associated with
Schedule II controlled substances. Consequently, DEA opted against this
alternative.
Finally, DEA is proposing the selected alternative, which would not
require an in-person medical evaluation such as required under the
first alternative and would allow certain qualified practitioners who
demonstrate a legitimate need to prescribe Schedule II controlled
substances through telemedicine unlike the second alternative. The
selected, proposed alternative would establish a Special Registration
framework pursuant to 21 U.S.C. 802(54)(E) and 21 U.S.C. 831(h), and
authorize three types of Special Registrations: the (1) Telemedicine
Prescribing Registration allowing qualified clinician practitioners to
prescribe Schedule III-V controlled substances via telemedicine; the
(2) Advanced Telemedicine Prescribing Registration, allowing qualified
specialized clinician practitioners (e.g., psychiatrists, hospice care
physicians) and board-certified mid-level practitioners to prescribe
Schedule II-V controlled substances via telemedicine, and (3) the
Telemedicine Platform Registration for covered online telemedicine
platforms in their capacity as platform practitioners.
Baseline. For our analysis of the economic impact of the selected
alternative, the baseline for the selected alternative is the period
before the temporary COVID-19 PHE exceptions to the Ryan Haight Act.
During the baseline period, under 21 U.S.C. 829(e), the Ryan Haight Act
has generally required an in-person medical evaluation prior to the
prescription of controlled substances.
Proposed Requirements. The Ryan Haight Act does, however, provide
an exception to this in-person medical evaluation requirement, where
the practitioner is ``engaged in the practice of telemedicine.'' The
Ryan Haight Act generally provides seven (7) distinct categories of the
practice of telemedicine in which a prescribing practitioner might be
unable to satisfy the Ryan Haight Act's in-person medical evaluation
requirement, yet nonetheless may be able to prescribe a controlled
substance for a legitimate medical purpose in the usual course of
professional practice. The proposed requirements would allow a
practitioner to obtain a Special Registration for Telemedicine, which
is one of the seven categories of the practice of telemedicine as
defined under the Ryan Haight Act. To engage in the practice of
telemedicine under the proposed Special Registration framework, the
practitioner must possess each of the following:
<bullet> An existing conventional DEA registration under 21 U.S.C.
823(g);
<bullet> One of the three types of Special Registration for
Telemedicine authorizing the prescribing of controlled substances via
telemedicine; and
<bullet> A State Telemedicine Registration allowing the prescribing
of controlled substances via telemedicine for each state in which a
patient is located.
[[Page 6566]]
[GRAPHIC] [TIFF OMITTED] TP17JA25.089
As Graphic 1 shows, these types of DEA registrations are interconnected
for the purposes of prescribing controlled substances under the Special
Registration framework. To issue a special registration prescription to
a patient located in a particular state, the practitioner must first
obtain a State Telemedicine Registration for that state. However, a
State Telemedicine Registration can only be obtained if the
practitioner already holds or is simultaneously applying for a Special
Registration for Telemedicine. In turn, the Special Registration for
Telemedicine requires that the practitioner have an existing
conventional DEA registration under 21 U.S.C. 823(g). The proposed rule
has certain requirements for:
1. The application process: such as reporting professional
affiliations with employers (21 CFR 1301.13(k)(2)(i)-(ii)), medical
specialty (as mentioned above) (21 CFR 1301.13(k)(2)(iv)), that the
practitioner will maintain anti-diversion policies (21 CFR
1301.13(k)(2)(iii)); and the facts and circumstances that form the
basis for a legitimate need for a Special Registration for
Telemedicine (21 CFR 1301.13(k)(2)(v)).
2. The prescription process: such as PDMP checks for the patient
state, special registrant state, and any states with reciprocity
agreement with either state (21 CFR 1306.43(a), a comprehensive
nationwide PDMP check for all 50 states and any U.S. districts and
territories that maintain a PDMP, if possible, starting three years
from the effective date of the final rule (21 CFR 1306.43(b)), all
prescriptions issued through EPCS (21 CFR 1306.42), telemedicine
encounters being audio-visual with limited exception (21 CFR
1306.44), the inclusion of additional elements on special
registration prescriptions (21 CFR 1306.47) and, for Schedule II
controlled substances, prescriptions issued for care under an
appropriate specialty and other safeguards (21 CFR 1306.45).
3. Recordkeeping and reporting requirements: such as patient
verification using photographic records (21 CFR 1304.04(i)), Special
Registration telemedicine encounter records (21 CFR 1304.04(j)),
credential verifications of clinician special registrants (21 CFR
1304.04(k)), centralized recordkeeping at the special registered
location (21 CFR 1304.04(l)), pharmacy reporting of telemedicine
prescription data to DEA (21 CFR 1304.60) and special registrant
reporting of the number of new telemedicine patients and
prescription aggregated data to DEA (21 CFR 1304.61).
The costs, cost savings, benefits, and transfers associated with
the proposed rule were evaluated from the perspective of the following
impacted parties: patients, practitioners (including mid-level
practitioners), pharmacies, healthcare systems, states, and society at
large. The high and low ranges of economic impact are based on two
factors: the rate of telemedicine visits resulting from this proposed
rule and the level of participation by registrants under the proposed
rule.
II. Patient Costs, Cost Savings, and Benefits
The proposed rule would benefit patients by reducing transportation
costs, travel time costs, and expanding access to medical care. The
cost savings associated with the proposed rule predominantly stem from
reductions in two costs: (1) the cost of time, and (2) the cost of
transportation.
A. Patient's Cost of Time per Practitioner Visit
To derive patients' cost of time, DEA needed to assess two factors:
the average length of time to travel and wait for a practitioner's
appointment, and the average opportunity cost (i.e., forgone wages) to
travel and wait for a practitioner's appointment. Simply put, (average
length of the time) x (opportunity cost) = patient's cost of time. To
determine an appropriate average length of time, DEA consulted relevant
medical articles. While the practice of telemedicine proposed in this
rule is a subset of telehealth that focuses on clinical services by
practitioners, broader telehealth research can inform our understanding
of telemedicine and provide a greater array of research to use in our
analysis. It is also common for research to indicate it relates to
``telehealth,'' even when it may be more appropriate to call it a
``telemedicine'' study.\111\
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\111\ Accordingly, in discussing such studies, DEA will use the
word the word ``telehealth'' instead of telemedicine.
---------------------------------------------------------------------------
To determine the average length of time to be used in this
analysis, DEA consulted various studies. A 2023 study focused on cancer
(non-elderly) telehealth patients treated between April 1, 2020, and
June 30, 2021. This study found that telehealth patients saved about
2.9 hours of round-trip driving time and 1.2 hours of in-clinic time
per visit, including time spent with a practitioner.\112\ However, as
this study focused on non-elderly cancer patients, it did not
adequately represent the broader scope of telehealth patients
considered in this analysis. In contrast, a 2019 study indicated that
the average length of time (combining travel and waiting time) was 45
minutes (0.75 hours) per visit.\113\ Given that 68.2 percent of all
current telehealth claims are related to mental health, not non-elderly
cancer patients, DEA believes that the 45-minute average is more
[[Page 6567]]
relevant for this analysis.\114\ DEA, however, acknowledges that there
may be significant variability in the average lengths of time across
different patient populations.
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\112\ Patel KB, Turner K, Alishahi Tabriz A, et al. Estimated
Indirect Cost Savings of Using Telehealth Among Nonelderly Patients
with Cancer. JAMA Netw Open. 2023;6(1):e2250211.
\113\ Rhyan C. Travel and Wait Times are Longest for Health Care
Services and Result in an Annual Opportunity Cost of $89 Billion.
Altarum. (Feb. 22, 2019), <a href="https://altarum.org/travel-and-wait">https://altarum.org/travel-and-wait</a>
(accessed 9/5/2023).
\114\ Fair Health, ``Monthly Telehealth Regional Tracker.''
<a href="https://www.fairhealth.org/fh-trackers/telehealth">https://www.fairhealth.org/fh-trackers/telehealth</a>. (accessed 8/4/
2023 selecting Jan 2020, which had Jan 2019 data, and May 2023 using
National Statistics data dropdown menu).
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To determine an appropriate average opportunity cost (i.e., forgone
wages) to travel and wait for a practitioner's appointment, DEA
consulted relevant data from the U.S. Bureau of Labor Statistics (BLS).
DEA used median hourly wage data for all occupations ($23.11) as a
proxy for the hourly average opportunity cost of travel and wait time
for all patients, as can be seen in Table 1 below.\115\ Additionally,
BLS reports that average wages and salaries for civilians are 68.8
percent of total compensation. The 68.8 percent of total compensation
equates to 45.3 percent (100 percent/68.8 percent--1) load on wages and
salaries.\116\ The load of 45.3 percent, or $10.47 (0.453 x $23.11), is
added to the hourly rate to estimate the loaded hourly rates. As can be
seen in Table 1, the loaded hourly wage for patients is $33.58 ($23.11
+ $10.47). Therefore, the $33.58 loaded hourly wage represents the
hourly average opportunity cost to travel and wait for a practitioner's
appointment.
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\115\ Bureau of Labor Statistics, Occupational Employment and
Wages, May 2023 National Occupational Employment and Wage Estimates,
Occupation code: 00-0000 All Occupations, <a href="https://www.bls.gov/oes/2023/may/oes_nat.htm">https://www.bls.gov/oes/2023/may/oes_nat.htm</a>.
\116\ Bureau of Labor Statistics, Employer Costs for Employee
Compensation--June 2024, <a href="https://www.bls.gov/news.release/archives/ecec_09102024.pdf">https://www.bls.gov/news.release/archives/ecec_09102024.pdf</a>. (accessed 11/13/2024).
Table 1--Patients Loaded Hourly Wage
----------------------------------------------------------------------------------------------------------------
Hourly wage Load for Loaded hourly
Occupation ($) benefits ($) wage ($)
----------------------------------------------------------------------------------------------------------------
All Occupations.............................................. 23.11 10.47 33.58
----------------------------------------------------------------------------------------------------------------
Therefore, the patient's cost of time to travel and wait for a
practitioner's visit--and thus the time cost savings achieved by
telemedicine patients who could forego such a trip--equals $25.19 (0.75
x $33.58), as can be seen in Table 2 below.
Table 2--Patient Cost of Time
[per Practitioner's Appointment]
----------------------------------------------------------------------------------------------------------------
Hourly Cost per
Cost savings opportunity Travel and wait appointment
cost ($) time (hours) ($)
----------------------------------------------------------------------------------------------------------------
Time cost savings............................................ 33.58 0.75 25.19
----------------------------------------------------------------------------------------------------------------
B. Patient's Cost of Travel per Practitioner Visit
To determine the cost of travel to and from a practitioner's
appointment, DEA used data from the Southwest Rural Health Research
Center in the Texas A&M School of Public Health, and mileage
reimbursement rates from the U.S. Internal Revenue Service (IRS).
According to a 2017 survey by the Southwest Rural Health Research
Center, the average national round-trip travel distance for a doctor's
visit was 9.9 miles, or 19.8 miles round-trip.\117\ The IRS travel
reimbursement rate for businesses is 67 cents per mile.\118\ Therefore,
the patient's cost of travel to and from a practitioner's appointment--
and thus the travel cost savings achieved by telemedicine patients who
could forego such a trip--equals $13.27 (19.8 miles x $0.67 per mile),
as can be seen in Table 3 below.
---------------------------------------------------------------------------
\117\ Akinlotan, M., Khodakarami, N., Primm, K., Bolin, J., and
Ferdinand, A.O. (Yen W. Rhyan C. Rural-Urban Variations in Travel
Burdens for Care: Findings from the 2017 National Household Travel
July 2021. <a href="https://srhrc.tamu.edu/publications/travel-burdens-07.2021.pdf">https://srhrc.tamu.edu/publications/travel-burdens-07.2021.pdf</a>. <a href="https://ofm.wa.gov/sites/default/files/public/legacy/researchbriefs/2013/brief070.pdf">https://ofm.wa.gov/sites/default/files/public/legacy/researchbriefs/2013/brief070.pdf</a> (accessed 9/24/2024).
\118\ Internal Revenue Service. Standard Mileage Rates, Notice
2024-08, <a href="https://www.irs.gov/pub/irs-drop/n-24-08.pdf">https://www.irs.gov/pub/irs-drop/n-24-08.pdf</a>. (accessed 10/
18/2024).
[…truncated; see source link]Indexed from Federal Register on January 17, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.