Federal Register, Volume 90 Issue 11 (Friday, January 17, 2025)

[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Rules and Regulations]
[Pages 6523-6540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01044]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1306

[Docket No. DEA-407VA]
RIN 1117-AB40; 1117-AB88

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 12

Continuity of Care via Telemedicine for Veterans Affairs Patients

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

ACTION: Final rule.

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SUMMARY: This final rule authorizes Department of Veterans Affairs (VA)
practitioners acting within the scope of their VA employment to
prescribe controlled substances via telemedicine to a VA patient with
whom they have not conducted an in-person medical evaluation. VA
practitioners are permitted to prescribe controlled substances to VA
patients if another VA practitioner has, at any time, previously
conducted an in-person medical evaluation of the VA patient, subject to
certain conditions.

DATES: This final rule is effective February 18, 2025.

FOR FURTHER INFORMATION CONTACT: Heather Achbach, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 776-3882.

SUPPLEMENTARY INFORMATION: This rule is a final rule that finalizes
portions of the proposed rule titled Telemedicine Prescribing of
Controlled Substances When the Practitioner and the Patient have Not
Had a Prior In-Person Medical Evaluation, specifically those proposed
regulations affecting VA practitioners prescribing controlled
substances.\1\ Under this final rule, a VA practitioner who is acting
within their scope of employment with the VA may prescribe controlled
substances while engaged in the practice of telemedicine with a VA
patient with whom they have not conducted an in-person medical
evaluation, if another VA practitioner has previously conducted an in-
person medical evaluation with the VA patient. Additionally, prior to
issuing a prescription via telemedicine for a

[[Page 6524]]

schedule II-V controlled substance, the prescribing practitioner must
review both the patient's VA electronic health record (EHR) (to include
the internal prescription database) and the prescription drug
monitoring program (PDMP) data for the state in which the VA patient is
located at the time of the telemedicine encounter (if the state has
such a program) for prescriptions of controlled substances issued to
the VA patient. Should either the VA EHR (to include the VA internal
prescription database) or the state PDMP (if the state has a PDMP
program) be unavailable or non-operational, the practitioner must limit
the prescription to a 7-day supply and must later review both the VA
patient's VA EHR (to include the internal prescription database) and
the PDMP data for the state in which the patient is located at the time
of the telemedicine encounter for prescriptions of controlled
substances issued to the patient before continuing to prescribe
controlled substances to the patient via telemedicine. If no PDMP
program exists for the state in which the VA patient is located at the
time of the telemedicine encounter the practitioner must review the VA
EHR, to include the VA internal prescription database, prior to issuing
a prescription for controlled substances for more than a 7-day supply.
For reasons discussed more fully below, this final rule does not apply
to contracted practitioners located outside a VA facility or clinic
providing care via the community care network (CCN) or conducting
disability compensation evaluations.
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\1\ 88 FR 12875 (Mar. 1, 2023).
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I. Legal Authority and Background

In March 2023, the Drug Enforcement Administration (DEA) published
a notice of proposed rulemaking (NPRM) titled Telemedicine Prescribing
of Controlled Substances When the Practitioner and the Patient Have Not
Had a Prior In-Person Medical Evaluation (the General Telemedicine
NPRM).\2\ DEA is now partially finalizing the rule, specifically the
sections of that proposed rule that pertain to Department of Veterans
Affairs (VA) practitioners.\3\ DEA has modified the proposed provisions
to address concerns brought forth by commenters that are specific to VA
practitioners prescribing controlled substances through the practice of
telemedicine under the statutory authority of 21 U.S.C. 802(54)(G).
This final rule pertains only to VA practitioners prescribing
controlled substances to VA patients in circumstances where the
prescribing VA practitioner has not conducted an in-person medical
evaluation of the VA patient prior to the issuance of the
prescription.\4\
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\2\ 88 FR 12875 (Mar. 1, 2023).
\3\ A ``VA practitioner'' refers to an individual authorized to
prescribe, dispense, or administer controlled substances within the
Department of Veterans Affairs, consistent with the definition of
``practitioner'' in 21 U.S.C. 802(21). This includes any licensed
individual permitted by the VA to perform professional medical
duties within the scope of VA healthcare practices.
\4\ Pursuant to 21 CFR 1300.04(f), the term ``in-person-medical
evaluation'' means a medical evaluation that is conducted with the
patient in the physical presence of the practitioner.
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This final rule falls under the last category of the ``practice of
telemedicine'' as defined in the Ryan Haight Online Pharmacy Consumer
Protection Act of 2008 (Ryan Haight Act),\5\ which authorizes the
prescribing of controlled substances in specified circumstances where
the prescribing practitioner has not conducted an in-person medical
evaluation of the patient. The Administrator of the DEA (pursuant to
delegation by the Attorney General) \6\ and the Secretary of Health and
Human Services (HHS) jointly issue this regulation and have both
determined that this regulation is consistent with effective controls
against diversion and with the public health and safety, as required
under 21 U.S.C. 802(54)(G).
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\5\ Public Law 110-425, 122 Stat. 4820 (2008).
\6\ The Attorney General has delegated this authority to the
Administrator of DEA under 28 CFR 0.100(b).
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DEA implements and enforces the Controlled Substances Act (CSA) and
the Controlled Substances Import and Export Act (21 U.S.C. 801-971), as
amended. DEA publishes the implementing regulations for these statutes
in 21 CFR parts 1300 through 1399. These regulations are designed to
ensure a sufficient supply of controlled substances for medical,
scientific, and other legitimate purposes, and to deter the diversion
of controlled substances for illicit purposes. As mandated by the CSA,
DEA establishes and maintains a closed system of control for
manufacturing, distributing, 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.\7\ The CSA further authorizes the
Attorney General (and the Administrator of DEA by delegation through 28
CFR part 0) to promulgate regulations necessary and appropriate to
execute the functions of subchapter I (Control and Enforcement) and
subchapter II (Import and Export) of the CSA.\8\
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\7\ The term ``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).
\8\ 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 Cosmetic Act may be . . . dispensed by means of the internet
without a valid prescription,'' \9\ and which defines ``valid
prescription'' in part 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 . . .'' \10\
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\9\ 21 U.S.C. 829(e)(1).
\10\ Id. 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 of
a covering practitioner 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 DEA-registered 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.
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However, pursuant to 21 U.S.C. 829(e)(3)(A), there is an exception
to this in-person medical evaluation requirement where the practitioner
is ``engaged in the practice of telemedicine.'' \11\ 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) \12\ 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 referred to in section 1395m(m) of Title 42,'' and which also
falls within

[[Page 6525]]

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.\13\
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\11\ Id. 829(e)(3)(A).
\12\ This definition of telemedicine does not exclude a
pharmacist functioning as a mid-level practitioner authorized to
prescribe controlled substances.
\13\ 21 U.S.C. 802(54).
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As a general matter, those seven distinct categories include
telemedicine encounters where: (1) patients are physically located at
DEA-registered hospital or clinic, and the remote prescribing
practitioner is DEA-registered in the state in which the patient is
located at the time of the telemedicine encounter; (2) patients are
being treated by a practitioner, and in the physical presence of a DEA-
registered practitioner in the state in which the patient is located;
(3) the practitioner is an employee or contractor of the Indian Health
Service, acting within the scope of the practitioner's employment, who
has been designated an Internet Eligible Controlled Substances Provider
by HHS; (4) they take place during a public health emergency declared
by HHS; (5) the practitioner has obtained a Special Registration with
DEA; \14\ (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.\15\
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\14\ 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, 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.
\15\ 21 U.S.C. 802(54).
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The seven distinct categories provided under the statutory
definition of the practice of telemedicine involve circumstances in
which the 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. 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.
As noted above, when a practitioner engages in the practice of
telemedicine, the practitioner must use ``a telecommunications system
referred to in section 1395m(m) of Title 42.'' The Centers for Medicare
and Medicaid Services has defined telehealth for the Medicare program,
in part, as ``multimedia communications equipment that includes, at a
minimum, audio and video equipment permitting two-way, real-time
interactive communication between the patient and distant site
physician or practitioner.'' \16\
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\16\ 42 CFR 410.78(a)(3).
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COVID-19 Public Health Emergency

In response to the COVID-19 public health emergency (PHE), as
declared by the Secretary of HHS on January 31, 2020, pursuant to the
authority under section 319 of the Public Health Service Act (42 U.S.C.
247), DEA granted temporary exceptions (listed below) to the Ryan
Haight Act. To prevent lapses in care, these exceptions authorized the
prescribing of controlled substances via telemedicine encounters even
when the prescribing practitioner had not conducted an in-person
medical evaluation of the patient prior to prescribing. These
telemedicine flexibilities authorized DEA-registered practitioners to
prescribe schedule II-V controlled substances via audio-video
telemedicine encounters, including schedule III-V narcotic controlled
substances approved by FDA for maintenance and withdrawal management
treatment of opioid use disorder via audio-only telemedicine
encounters, provided that such controlled substance prescriptions
otherwise comply with the requirements outlined in DEA guidance
documents, DEA regulations, and applicable Federal and State law. DEA
granted those temporary exceptions to the Ryan Haight Act and DEA's
implementing regulations via two letters published in March 2020:
A March 25, 2020 ``Dear Registrant'' letter signed by
William T. McDermott, DEA's then-Assistant Administrator, Diversion
Control Division; \17\ and
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\17\ William T. McDermott, DEA Dear Registrant letter, Drug
Enforcement Administration (March 25, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf.
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A March 31, 2020 ``Dear Registrant'' letter signed by
Thomas W. Prevoznik, DEA's then-Deputy Assistant Administrator,
Diversion Control Division.\18\
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\18\ Thomas W. Prevoznik, DEA Dear Registrant letter, Drug
Enforcement Administration (March 31, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Fina
l)%20+Esign.pdf.
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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), published 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) \19\ and Expansion of Induction of
Buprenorphine via Telemedicine Encounter (the Buprenorphine NPRM).\20\
These NPRMs proposed to expand patient access to prescriptions for
controlled substances via telemedicine encounters relative to the pre-
COVID-19 PHE landscape. The intent 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.
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\19\ 88 FR 12875 (Mar. 1, 2023).
\20\ 88 FR 12890 (Mar. 1, 2023).
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The General Telemedicine NPRM proposed specific requirements for
telemedicine prescribing of controlled substances by both VA and non-VA
practitioners, addressing both the types of drugs permitted and the
procedural safeguards necessary for prescribing via telemedicine
without an in-person medical evaluation. For practitioners, the General
Telemedicine NPRM proposed permitting prescribing schedule III-V non-
narcotic controlled substances via telemedicine for up to a 30-day
supply prior to conducting an in-person medical evaluation. However,
for schedule II substances or narcotics, or any controlled substance
prescription exceeding a 30-day supply, the General Telemedicine NPRM
proposed that a ``qualifying telemedicine referral'' is necessary. As
proposed in the General Telemedicine NPRM, the qualifying

[[Page 6526]]

referral would involve a physical evaluation conducted by another DEA-
registered practitioner, who would then formally refer the patient to
the prescribing practitioner. Additionally, practitioners would be
required to conduct a review of the PDMP for the state where the
patient is located at the time of the telemedicine encounter to monitor
recent controlled substance prescriptions, as a safeguard against
potential misuse. The General Telemedicine NPRM proposed that in
instances where the PDMP is temporarily unavailable, the prescribing
practitioner would be authorized to prescribe up to a 7-day supply
until the prescribing practitioner is able to review the PDMP.
The General Telemedicine NPRM also proposed to mandate detailed
recordkeeping, whereby the telemedicine practitioner would be required
to thoroughly document each controlled substance prescribed via
telemedicine, including the date, patient details, medication
specifics, and locations of both the practitioner and the patient
during the encounter. Moreover, each prescription issued via a
telemedicine encounter would be required to bear a notation on its face
indicating it was issued via a telemedicine encounter. These extra
safeguards were intended to provide an additional layer of transparency
for DEA audits and investigations.
The General Telemedicine NPRM proposed certain provisions for VA
practitioners prescribing controlled substances via telemedicine.
Specifically, VA practitioners prescribing controlled substances during
telemedicine encounters with VA patients utilizing the VA healthcare
system would be exempt from the 30-day supply limitation, allowing VA
practitioners to prescribe controlled substances, including schedule II
drugs, without a qualifying referral. This proposed exemption
recognized the VA's integrated healthcare system, and the reliable,
centralized patient data systems bridging all VA facilities, which
ensures a continuity of patient care provided within its healthcare
system. To mitigate risks related to diversion or misuse, the General
Telemedicine NPRM proposed to require VA practitioners to consult not
only the PDMP for the state the VA patient is located during the
telemedicine encounter, but also the VA's internal prescription
database, ensuring a comprehensive review of the VA patient's
controlled substance prescription history.
These distinctions underscore DEA's intention in the General
Telemedicine NPRM to balance access to care via telemedicine with the
necessary safeguards against diversion or misuse of controlled
substances. Specifically, the General Telemedicine NPRM emphasized the
continuity and security of care for VA patients receiving healthcare
services through the VA system. By structuring the requirements
differently for VA and non-VA practitioners, the General Telemedicine
NPRM sought to leverage the VA's established telemedicine
infrastructure and patient monitoring capabilities to enhance safety
without imposing excessive restrictions on the VA's healthcare delivery
model. Unlike other healthcare providers, VA operates under Federal law
and is a nationally integrated, closed healthcare system with rigorous
internal policies and controls that ensure patient safety, continuity
of care, and thorough monitoring of prescriptions. VA practitioners
have access to shared information systems that enable continuity of
care and veterans' data sharing across VA facilities. This includes
access to VA's internal prescription database, allowing VA
practitioners to monitor and manage controlled substance prescriptions.
This infrastructure ensures the safety of telemedicine prescribing
without necessitating an additional registration layer, as VA
practitioners operate within a highly regulated and cohesive system
tailored specifically to veterans' needs.
The comment period for the General Telemedicine NPRM and
Buprenorphine NPRM closed on March 31, 2023. The General Telemedicine
NPRM generated a total of 35,454 comments.
On May 10, 2023, DEA jointly with HHS (with the Substance Abuse and
Mental Health Services Administration (SAMHSA) acting on behalf of HHS)
issued a Temporary Extension of COVID-19 Telemedicine Flexibilities for
Prescription of Controlled Medications (First Temporary Rule) pursuant
to 21 U.S.C. 802(54)(G), which extended through November 11, 2023, the
full set of telemedicine flexibilities regarding the prescribing of
controlled substances, as had been in place under the COVID-19 PHE.\21\
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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\21\ Temporary Extension of COVID-19 Telemedicine Flexibilities
for Prescription of Controlled Medications, 88 FR 30037 (May 10,
2023).
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On September 12 and 13, 2023, DEA hosted live, in-person
Telemedicine Listening Sessions to receive additional public input
concerning the practice of telemedicine with regard 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 prescribing of certain controlled
substances via telemedicine 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,
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
General Telemedicine and Buprenorphine NPRMs and the presentations at
the Telemedicine Listening Sessions, DEA, jointly with HHS, issued the
Second Temporary Extension of COVID-19 Telemedicine Flexibilities for
Prescription of Controlled Medications (Second Temporary Rule), also
pursuant to 21 U.S.C. 802(54)(G), thereby extending through December
31, 2024, the full set of telemedicine flexibilities regarding
prescription of controlled substances as were in place during the
COVID-19 PHE.\22\ 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
DEA-registered practitioner had 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 the
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 DEA-registered

[[Page 6527]]

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.
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\22\ 88 FR 30037 (May 10, 2023).
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On November 19, 2024, DEA and HHS issued a Third Temporary
Extension of COVID-19 Telemedicine Flexibilities for Prescription of
Controlled Medications (Third Temporary Rule) to again extend the
temporary exceptions originally authorized under the COVID-19 PHE,
through December 31, 2025. This extension allows telemedicine
flexibilities for all practitioners, extending patient access to care
until broader telemedicine rulemaking is complete. Additionally, these
temporary exemptions, now extended through December 31, 2025, ensure
that practitioners can continue to prescribe controlled substances
without an in-person medical evaluation, maintaining continuity of care
while DEA works to establish tailored regulations for both VA and non-
VA practitioners. DEA's NPRM titled Special Registrations for
Telemedicine and Limited State Telemedicine Registrations (RIN 1117-
AB40) (Special Registrations NPRM), published elsewhere in this issue
of the Federal Register, focuses on non-VA practitioners and allows for
further opportunity for public comment and development of a framework
suited to the diverse operational environments outside the VA's
integrated healthcare system.
DEA is specifically tailoring this final rule to practitioners
within the VA healthcare system to accommodate VA's unique healthcare
infrastructure while safeguarding effective prescribing of controlled
substances via telemedicine. This final rule is distinct from the
broader Special Registrations NPRM to acknowledge the VA's unique
structure and patient population, particularly VA patients in rural or
underserved areas who benefit significantly from telemedicine services.
This final rule reflects the VA's robust internal controls and
centralized framework, which ensure continuity and quality of care
across VA facilities and practitioners.
After careful consideration of the public comments and discussions
with the VA, DEA and HHS have decided to promulgate this final rule
only with respect to VA practitioners. Specifically, DEA and HHS have
decided to extend telemedicine prescribing authority to VA
practitioners to accommodate VA's unique healthcare infrastructure
while safeguarding effective prescribing of controlled substances via
telemedicine. Unlike non-VA practitioners, who operate in a variety of
healthcare systems with diverse, non-integrated records management
structures, VA practitioners are governed by a unified, closed-loop
healthcare system, which offers comprehensive patient oversight,
centralized health information and a dedicated internal prescription
database, facilitating safe and effective telemedicine practices
specific to VA patients and veterans' healthcare needs. Thus, DEA and
HHS believe that promulgating this final rule would maintain critical
patient access to necessary medications without creating an
unreasonable risk of diversion. Although DEA and HHS are not extending
this authority to non-VA practitioners at this time, DEA is committed
to working with HHS to periodically evaluate whether extending
telemedicine prescribing authority to non-VA practitioners under 21
U.S.C. 802(54)(G) would be appropriate in the future.
Additionally, DEA notes that the Special Registrations NPRM,
proposes to create a special registration for telemedicine which would
authorize telemedicine prescribing authority for non-VA practitioners.
DEA encourages the public to review and comment on that proposed rule.

II. Need for Rulemaking Specific to the Department of Veteran Affairs

As a result of discussions held between DEA, HHS, and the VA, as
well as the comments received in response to the General Telemedicine
NPRM, DEA and HHS have determined that the best course of action to
ensure continued access to care for patients receiving care from VA
healthcare, while maintaining sufficient safeguards to detect and
protect against the diversion of controlled substances, is to
promulgate regulatory changes that enable a VA practitioner to
prescribe controlled substances, via telemedicine, to a VA patient who
has previously had an in-person medical evaluation with a different VA
practitioner. The proposed expansion of authorized internet prescribing
for VA practitioners responds directly to the evolving landscape of the
healthcare needs of VA patients, advancements in telemedicine, and
DEA's capacity to implement safeguards that protect against potential
misuse. The need for comprehensive, accessible medical care for VA
patients has been a consistent priority; however, recent factors
underscore the necessity for regulatory updates. Notably, the COVID-19
pandemic accelerated the adoption and acceptance of telemedicine,
demonstrating its effectiveness in maintaining continuity of care
without in-person interactions, particularly for vulnerable populations
as discussed below.\23\ This shift has underscored the need for
accessible controlled-substance prescribing via telemedicine, enabling
VA practitioners to respond swiftly and safely to VA patients'
healthcare needs. VA now has improved tools and data systems, including
enhanced monitoring of telemedicine practices and centralized systems
like the VA's internal prescription monitoring database, allowing for
more effective oversight than what was available in the past.\24\ These
advances support a framework that meets current clinical and oversight
needs.
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\23\ Aday, L.A. (2002). At Risk in America: The Health and
Health Care Needs of Vulnerable Populations in the United States, 2
(13).
\24\ Frequently Asked Questions--VA EHR Modernization. https://
digital.va.gov/ehr-modernization/frequently-asked-question/
#:~:text=VA%27s%20Electronic%20Health%20Record%20Modernization%20(EHR
M)%20program%20is%20managing%20the,)%2C%20to%20the%20Federal%20EHR.
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Further, alternative telemedicine provisions, such as those
outlined in 21 U.S.C. 802(54)(A)-(B), (F), are insufficient to address
the unique policy goals of this rulemaking. For instance, the
requirement for an in-person medical evaluation to establish a
prescribing relationship fails to accommodate VA patients with limited
mobility, access issues, or chronic health conditions that make travel
difficult. While theoretically possible for some VA patients to attend
an in-person medical evaluation with every provider, practical barriers
mean that an in-person medical evaluation is often not feasible or
results in delayed access to needed medications. VA's centralized
healthcare model offers a unique opportunity to manage these challenges
responsibly, with systems that allow for comprehensive patient
oversight across facilities, secure data sharing, and a controlled,
consistent telemedicine infrastructure. The rule thus leverages the
VA's specific capabilities to meet VA patients' needs without over-
relying on a one-size-fits-all approach to telemedicine, creating
tailored, effective access to care for VA patients while maintaining
appropriate oversight that ensures the continued protection of patient
health through the mitigation of diversion and prevention of
overprescribing.
This approach is based on several considerations:

A. Specialized Needs of Veterans

Upon separation from the military, many veterans face physical,
mental,

[[Page 6528]]

and social issues that categorize them as a vulnerable population. Due
to the nature of their military service, the veteran population is
comprised of individuals who may be diagnosed with serious medical
conditions which require specialized care.\25\ Some of these medical
conditions include, but are not limited to, traumatic brain injury,
Post-Traumatic Stress Disorder (PTSD), loss of limb(s), and medical
conditions related to exposure to hazardous environments and materials
(e.g., medical conditions associated with the exposure to the herbicide
``Agent Orange'' during the Vietnam War).\26\ To ensure that VA is able
to accomplish its mission to provide comprehensive medical care to all
veterans receiving care through its healthcare system, this final rule
provides that VA practitioners are authorized to prescribe controlled
substances via telemedicine, so long as the VA patient has an
established medical relationship with any VA practitioner who has
conducted at least one in-person medical evaluation of the patient, at
any time, among other requirements. It is important to note, that
within the scope of this final rule, ``VA patient'' refers to a veteran
as defined in 38 CFR 3.1 as ``a person who served in the active
military, naval, or space service and who was discharged or released
under conditions other than dishonorable'' and is receiving medical
care via the VA healthcare system. It also includes persons otherwise
eligible under title 38, United States Code, or any other law
authorizing the Secretary of Veterans Affairs to furnish health care.
---------------------------------------------------------------------------

\25\ Moore MJ, Shawler E, Jordan CH, et al. Veteran and Military
Mental Health Issues. Updated 2023 Aug 17. In: StatPearls
[Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.
Available from: https://www.ncbi.nlm.nih.gov/books/NBK572092/.
\26\ The Department of Veterans Affairs, Annual Benefits Report
2023 (2023), https://www.benefits.va.gov/REPORTS/abr/docs/2023-abr.pdf.
---------------------------------------------------------------------------

1. Vulnerable Population. The veteran population is comprised of
individuals from a cross-section of the American people, including the
elderly, disabled, chronically ill, racial and ethnic minorities,
individuals who identify as lesbian, gay, bisexual, transgender, or
queer (LGBTQ), and those who are economically disadvantaged.\27\ These
vulnerable groups face an increased risk of health-related problems,
and due to a lack of access to health care, their mortality rates are
higher, and their quality of life may be lower than that of the
American population at-large.\28\ \29\
---------------------------------------------------------------------------

\27\ Ernstmeyer K, Christman E. (2022). Nursing: Mental Health
and Community Concepts, Vulnerable Populations. https://www.ncbi.nlm.nih.gov/books/NBK590046/#.
\28\ Aday, L.A. (2002). At Risk in America: The Health and
Health Care Needs of Vulnerable Populations in the United States, 2
(13).
\29\ Waisel, D.B. (2013). Vulnerable populations in healthcare,
Current Opinion in Anesthesiology 26(2), 186-192.
---------------------------------------------------------------------------

2. Geographic and Physical Barriers to Care. Approximately 2.7
million veterans receive VA healthcare and live in rural or underserved
areas where access to healthcare facilities is limited, particularly
for the complex care needed by many veterans.\30\ \31\ Of these
veterans, 54 percent are aged 65 or older, and 44 percent earn less
than $35,000 per year.\32\ Requiring frequent in-person medical
evaluation for veterans who have already established a relationship
with the VA healthcare system would create a significant barrier to
care, potentially leading to undiagnosed or untreated conditions and
worsening health outcomes.
---------------------------------------------------------------------------

\30\ The Department of Veterans Affairs, Office of Rural Health
Annual Report (2023), https://www.va.gov/HEALTH/docs/annual-reports/ORH2842_2023_Thrive_051524_508c.pdf.
\31\ The Department of Veterans Affairs, Care of Complex Chronic
Conditions (2024), https://www.hsrd.research.va.gov/research/portfolio_description.cfm?Sulu=9.
\32\ The Department of Veterans Affairs, Office of Rural Health
Annual Report (2023), https://www.va.gov/HEALTH/docs/annual-reports/ORH2842_2023_Thrive_051524_508c.pdf.
---------------------------------------------------------------------------

Additionally, for veterans with significant mobility issues or
chronic pain, traveling to in-person appointments can be daunting and
may discourage them from seeking necessary medical attention.\33\ One
of the top five cited reasons that veterans cancel medical appointments
is transportation issues.\34\ Authorizing VA practitioners to prescribe
controlled substance medications via telemedicine would facilitate
access to medications that are crucial for managing patients' overall
health and wellbeing.
---------------------------------------------------------------------------

\33\ Musich, S., et al. (2018). The impact of mobility
limitations on health outcomes among older adults. Geriatric
Nursing, 39(2), 162-169. https://www.sciencedirect.com/science/article/pii/S0197457217302057?via%3Dihub.
\34\ VA's Veterans Engineering Research Council. https://www.research.va.gov/.
---------------------------------------------------------------------------

3. Mental Health Considerations. Veterans have a higher risk for
mental health disorders, traumatic brain injuries, and suicide when
compared to their civilian counterparts.\35\ One in three veterans
experience some type of mental health issue, including but not limited
to PTSD, depression, or anxiety.\36\ In the 2023 VA Annual Benefits
Report, 2,564,653 veterans were receiving disability compensation
benefits for a mental health condition. Of these, 1.4 million were for
PTSD and an additional 322,158 veterans were receiving benefits for
major depressive disorder.\37\ The stigma associated with seeking
mental health help can deter veterans from attending in-person
appointments, making telehealth an essential alternative path to
receiving care.\38\ By allowing VA practitioners to prescribe
controlled substances without requiring more than one in-person medical
evaluation with a VA practitioner, this final rule will support the
mental health needs of the veteran community, making it easier for them
to access treatments and controlled substance medications that can
significantly improve their quality of life.
---------------------------------------------------------------------------

\35\ Ernstmeyer K, Christman E. (2022). Nursing: Mental Health
and Community Concepts, Vulnerable Populations. https://www.ncbi.nlm.nih.gov/books/NBK590046/#.
\36\ Id.
\37\ The Department of Veterans Affairs, Annual Benefits Report
2023 (2023), 103, https://www.benefits.va.gov/REPORTS/abr/docs/2023-abr.pdf.
\38\ McGuffin, J.J., Riggs, S.A., Raiche, E.M., & Romero, D.H.
(2021). Military and Veteran help-seeking behaviors: Role of mental
health stigma and leadership. Military Psychology, 33(5), 332-340.
https://doi.org/10.1080/08995605.2021.1962181.
---------------------------------------------------------------------------

B. Unique Structure of VA Health Care

The VHA is one of the largest Federal health care systems in the
United States, providing care at more than 1,300 facilities, including
more than 150 VA Medical Centers and 1,100 VHA outpatient clinics to
over 9 million veterans in the integrated VA health care program.\39\
\40\ As a Federal healthcare system, the VA establishes, maintains, and
ensures compliance with standardized internal policies and procedures,
including those to prevent and detect diversion of controlled
substances, and engages in quality improvement and inspection
activities.\41\
---------------------------------------------------------------------------

\39\ It is important to note that the VA is comprised of three
entities that serve unique missions: (1) the Veteran Benefits
Administration, which provides benefits and services, such as
disability compensation and needs-based pension benefits; (2) the
VHA, which provides healthcare to veterans; and (3) the National
Cemetery Administration, which provides veterans with burial
services and memorials. The scope of this final rule focuses solely
on the VHA, as it is responsible for the administration of
healthcare to the veteran population.
\40\ About VHA--Veterans Health Administration (va.gov). As a
general matter, integrated healthcare refers to ``coordinated care
that addresses all aspects of patient health, focuses on a patient's
individual needs, and involves a multidisciplinary team of health
care professionals.'' https://www.va.gov/health/
aboutvha.asp#:~:text=The%20Veterans%20Health%20Administration%20(VHA,
Veterans%20enrolled%20in%20the%20VA.
\41\ Readiness for the Patient-Centered Medical Home: Structural
Capabilities of Massachusetts Primary Care Practices--PMC (nih.gov)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2629002/Id.; and
Concerns of Primary Care Clinicians Practicing in an Integrated
Health System: a Qualitative Study--PMC (nih.gov). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7661604/.

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[[Page 6529]]

1. VA Oversight and Control. The VA's continued commitment to
patient safety is evidenced by its ongoing efforts to combat
prescription drug misuse through education, monitoring, and
intervention programs. These rigorous internal controls include regular
audits, prescription monitoring programs, and adherence to established
clinical guidelines, ensuring that controlled substances are prescribed
ethically and as appropriate for the patient.\42\ Additionally, the VA
continues to collaborate closely with DEA and other regulatory bodies
to ensure compliance with applicable Federal and state regulations
related to prescribing controlled substances, including to ensure that
VA practitioners acting in the usual course of their professional
practice issue controlled substance prescriptions for legitimate
medical purposes. This continued partnership enhances the VA's ability
to maintain high standards of care while ensuring the safety of
veterans receiving controlled substances.
---------------------------------------------------------------------------

\42\ VA healthcare regulations establish a range of protections
and safeguards for veterans and VA patients. See 38 U.S.C. 1701 et
seq; 38 CFR parts 17 through 80.
---------------------------------------------------------------------------

2. Movement Towards an Integrated EHR. As a Federal health care
system, VA delivers standardized medical care through multidisciplinary
team(s) of health care professionals who share information regarding
veteran patients through data systems that cross VA facilities.\43\
VA's national, integrated health care system allows VA practitioners to
access information on a VA patient's encounter history, prior
prescriptions, and any relevant treatment plans. VA is transitioning
from its current medical records system to a more robust Federal EHR
which will share information among the VA, the Department of Defense,
the U.S. Coast Guard, the National Oceanic and Atmospheric
Administration, and participating community care providers.\44\
---------------------------------------------------------------------------

\43\ Ten Key Principles for Successful Health Systems
Integration--PMC (nih.gov). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3004930/.
\44\ Frequently Asked Questions--VA EHR Modernization. https://
digital.va.gov/ehr-modernization/frequently-asked-question/
#:~:text=VA%27s%20Electronic%20Health%20Record%20Modernization%20(EHR
M)%20program%20is%20managing%20the,)%2C%20to%20the%20Federal%20EHR.
---------------------------------------------------------------------------

III. Summary of the General Telemedicine NPRM's Veteran Affairs-
Specific Provisions and Changes in This Final Rule

As noted above, safeguards within the regulations proposed in the
General Telemedicine NPRM generally would have limited initial
prescriptions of non-narcotic schedules III-V controlled substances to
no more than a 30-day supply in instances where the patient had never
had an in-person medical evaluation with the prescribing practitioner,
and additional prescriptions beyond the initial 30-day prescription
would have required that the patient undergo an in-person medical
evaluation. The proposed General Telemedicine NPRM also would have
generally prohibited the telemedicine prescribing of schedule II and
narcotic controlled substances in schedules III through V, unless there
had been a qualifying referral.
As also noted above, in the General Telemedicine NPRM, the
provisions governing VA practitioners largely took the form of
exemptions from these safeguards applicable to non-VA practitioners.
Specifically, the General Telemedicine NPRM proposed that, subject to
safeguards discussed below, a VA practitioner would be authorized to
issue a prescription for controlled substances via telemedicine to a VA
patient without a qualifying referral if that VA patient had previously
been evaluated in-person by a VA practitioner. It additionally proposed
that the VA practitioner would be authorized to prescribe a supply in
addition to the 30-day supply if the in-person medical evaluation had
been conducted by a VA practitioner. The NPRM proposed this would
include controlled substances in schedules II-V.
In addition to these proposed exemptions from some of the
safeguards in the General Telemedicine NPRM, VA practitioners would
also be subject to certain additional safeguards relative to other
telemedicine practitioners. Specifically, before prescribing controlled
substances pursuant to the regulations proposed in the General
Telemedicine NPRM, VA practitioners would be required to review not
only the PDMP of the state in which the patient was located at the time
of the telemedicine visit, but also the VA's internal prescription
database when prescribing controlled substances via telemedicine.
After reviewing comments received in response to the General
Telemedicine NPRM, as will be discussed in more detail below, DEA and
HHS are adopting this final rule to treat VA practitioners as was
proposed in the General Telemedicine NPRM. However, while the General
Telemedicine NPRM proposed a generally applicable telemedicine scheme,
and then created exemptions or additional requirements for VA
practitioners relative to that generally applicable scheme, DEA and HHS
are now finalizing only the proposed treatment of VA practitioners from
the General Telemedicine NPRM, without finalizing the broader scheme.
Most notably, when VA patients have had an in-person medical evaluation
with a VA practitioner previously, this final rule authorizes a
different VA practitioner, via the practice of telemedicine, to issue
prescriptions for that patient for schedule II-V controlled substances,
without being limited to a 30-day supply.
In this final rule, DEA and HHS are also finalizing, among other
things, the General Telemedicine NPRM's proposed requirement for a VA
practitioner to review the VA's internal prescription database and the
PDMP data of the state in which the patient is located during the
telemedicine encounter prior to issuing a prescription via
telemedicine. It also finalizes the proposed requirement that a
prescription for controlled substances be limited to a 7-day supply in
situations when either the VA's internal prescription database or the
PDMP data of the state in which the patient is located during the
telemedicine encounter is unavailable or non-operational. It also
requires that under circumstances where the VA patient is located in a
state which does not have a PDMP program, the VA practitioner review
the VA EHR prior to issuing a prescription for controlled substances in
excess of a 7-day supply. DEA and HHS believe these changes will
provide VA practitioners with necessary and appropriate flexibilities
to provide care for our Nation's veterans, while still ensuring
effective controls are in place to safeguard against diversion or
misuse of controlled substances.

IV. Discussion of Veteran-Related Public Comments Received in Response
to the March 1, 2023, General Telemedicine NPRM

DEA received a total of 233 veteran-related comments in response to
the General Telemedicine NPRM.\45\ Of those comments, 87 focused on
non-VA healthcare or unrelated issues and therefore are outside the
scope of this final rule, as this rulemaking focuses solely on the
practice of telemedicine by VA practitioners within the VA

[[Page 6530]]

healthcare system. As such, those comments will not be discussed
further within this rulemaking. DEA and HHS thank all commenters for
their input during the telemedicine rulemaking process.
---------------------------------------------------------------------------

\45\ 88 FR 12875 (Mar. 1, 2023).
---------------------------------------------------------------------------

In this final rule, DEA and HHS are only finalizing the proposals
specific to the VA from the General Telemedicine NPRM. Therefore, in
this final rule DEA will not be responding to comments deemed outside
the scope of VA telemedicine. Moreover, the Special Registrations NPRM,
focuses on non-VA practitioners and allows for further opportunity for
public comment and additional development of a framework suited to the
diverse operational environments outside the VA's integrated healthcare
system. DEA has grouped the comments into several distinct categories
below in order to effectively summarize and respond to the VA-related
comments received in response to the General Telemedicine NPRM. Of the
comments received, some comments pertained to only one issue while
others encompassed several issues.

In-Person Medical Evaluation Requirement

Comment: DEA received the largest number of comments with concerns
pertaining to the General Telemedicine NPRM's proposed requirement
that, as a general matter, would require an in-person medical
evaluation as a predicate to receiving a telemedicine prescription for
either (1) a schedule II substance or a narcotic controlled substance
in schedules III-V or (2) more than a 30-day supply of a non-narcotic
controlled substance in schedules III-V. Specifically, commenters
stated that requiring an in-person medical evaluation to receive such
prescriptions would create an undue barrier for veterans seeking care
within the VA healthcare system.
Response: DEA and HHS recognize the hardships an in-person medical
evaluation requirement could cause to receive such prescriptions and
why this requirement could be burdensome to VA patients.\46\
Consequently, this final rule expands the telemedicine prescribing
authority of VA practitioners so long as another VA practitioner has
conducted an in-person medical evaluation with the VA patient. This
expansion eliminates the need for a VA patient to undergo an in-person
medical evaluation with the prescribing practitioner prior to receiving
telemedicine services. For the reasons discussed above, DEA and HHS
believe that this expansion reduces the burdens placed on VA patients
receiving medical care from the VA and addresses these commenters'
concerns, while at the same time providing sufficient safeguards
against diversion.
---------------------------------------------------------------------------

\46\ DEA is proposing to address this issue more generally for
individuals outside of the VA healthcare system under the Special
Registrations NPRM.
---------------------------------------------------------------------------

Access to Care

Comment: DEA received 45 comments raising concerns about the
challenges VA patients face, including disabilities that cause mobility
issues and residency in rural areas, emphasizing that telemedicine is
often their only viable option for accessing healthcare (particularly
specialized care). Commenters asserted that the General Telemedicine
NPRM posed practical barriers to care due to the burdens associated
with conducting an in-person medical evaluation, such as long travel
times and lack of available providers.
Response: DEA and HHS acknowledge that in-person medical evaluation
requirements may be burdensome for patients with limited ability,
either geographically or physically, to receive an in-person medical
evaluation in order to be prescribed controlled substances either in
the first instance or for additional duration. As noted above, this
final rule authorizes indefinite prescribing via telemedicine so long
as the VA patient has previously had at least one prior in-person
medical evaluation with another VA practitioner. DEA and HHS believe
that this will reduce the overall burden placed on VA patients living
in rural areas and those with mobility issues, while still providing
sufficient safeguards against diversion.

Negative Impact on VA Patients and VA Healthcare

Comment: DEA received 39 comments specifically highlighting
potential adverse effects the General Telemedicine NPRM's in-person
medical evaluation requirements would have on VA patients, including
veterans, who rely on VA telemedicine services. Commenters stated that
the VA's national telemedicine system, which is considered efficient
and widely utilized, could be impacted by an in-person medical
evaluation requirement. Many of these commenters urged for an exemption
for VA practitioners due to the unique needs of the VA's patient
population, which includes veterans.
Response: DEA and HHS agree that VA's use of telemedicine services
has been effective and has taken under advisement the potential impact
that any restrictions would impose on the VA healthcare system.
Accordingly, this final rule authorizes indefinite prescribing via
telemedicine so long as the VA patient has previously had at least one
prior in-person medical evaluation with another VA practitioner, as
noted above.

Mental Health Care

Comment: DEA received 28 comments from mental health professionals
or patients within the VA healthcare system who emphasized the
importance of telemedicine in providing continuous care for VA patients
with mental health conditions. These commentors raised concerns that
limiting telemedicine would have severe consequences for VA patient
populations, including veterans.
Response: DEA and HHS recognize the unique challenges that mental
health patients and providers face, particularly as it relates to
veterans. DEA and HHS note that 1 in 3 veterans experience some type of
mental health issue, including, but not limited to, PTSD, depression,
and anxiety.\47\ DEA and HHS believe that the changes incorporated
within this final rule provide an environment where continuity of care
can be maintained, while still helping to ensure VA patient safety and
safeguard against diversion.
---------------------------------------------------------------------------

\47\ McGuffin, J. J., Riggs, S.A., Raiche, E.M., & Romero, D.H.
(2021). Military and Veteran help-seeking behaviors: Role of mental
health stigma and leadership. Military Psychology, 33(5), 332-340.
https://doi.org/10.1080/08995605.2021.1962181.
---------------------------------------------------------------------------

V. Scope of Final Rule

Once an in-person medical evaluation of a VA patient has been
conducted by a VA practitioner, this practitioner-patient relationship
is extended to all VA practitioners engaging in the practice of
telemedicine (which is defined as ``telehealth'' in 38 CFR 17.417).\48\
Under such circumstances, this rulemaking essentially avoids the need
for VA practitioners to obtain a DEA Special Registration for
telemedicine before issuing prescriptions for controlled substances;
such Special Registrations are the subject of the Special Registrations
NPRM. The VA-specific regulations discussed below align with DEA's core
responsibilities of regulating controlled substances, while enabling
the VA to leverage its existing integrated and standardized model of
care to allow VA practitioners to prescribe controlled substances to VA
patients when they have not conducted an in-person medical evaluation.
It is important to

[[Page 6531]]

emphasize that this final rule will only be applicable in situations
where the VA patient has previously undergone an in-person medical
evaluation with a VA practitioner, thus establishing a preexisting
relationship of care with the VA healthcare system. A preexisting
relationship of care between a VA patient and the VA healthcare system
will be deemed to exist if, even prior to promulgation of this rule,
the VA patient has undergone an in-person medical evaluation with a VA
practitioner. The changes to DEA's regulations are consistent ``with
effective controls against diversion and otherwise consistent with the
public health and safety'' pursuant to 21 U.S.C. 802(54)(G). DEA is
promulgating these regulatory changes in concert with HHS, and HHS was
consulted in the creation of these regulatory provisions and concurs
with this rulemaking. HHS also has advised DEA that no further
rulemaking by HHS is necessary for the promulgation of this joint final
rule. Moreover, these regulations, and DEA regulations generally, do
not apply to telehealth encounters that do not result in a prescription
for controlled substances.\49\ Simply put, the regulations promulgated
in this final rule do not apply unless a VA practitioner deems it
necessary to prescribe controlled substances to a VA patient via
telemedicine and that VA patient has previously had an in-person
medical evaluation performed by a VA practitioner.
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\48\ 38 CFR 17.417(a)(4) and (b) define a healthcare
professional's scope while practicing telemedicine within the VA
healthcare system.
\49\ 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 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 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.
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The following provides the criteria that must be met to allow a VA
practitioner to engage in the practice of telemedicine under this final
rule:
A. Criteria for Practitioners. To be eligible for the provisions
within these regulations, the VA practitioner must meet each of the
following criteria:
i. Be either employed by, or in contract with, the VA, and be
operating within the scope of their employment as defined in 38 CFR
17.419.\50\
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\50\ 38 CFR 17.419 provides the requirements for an individual
to be considered a health care professional within the scope of the
VA healthcare system.
---------------------------------------------------------------------------

ii. For VA contracted practitioners, the prescribing practitioner
conducting the telemedicine encounter must be practicing at either a VA
facility or a VA community clinic. For the scope of this rule,
practitioners providing medical care to VA patients as part of the
Community Care Network (CCN) are not considered to be practicing within
a VA facility or a VA community clinic.
iii. Be registered with DEA under 21 U.S.C 823(g) in any State or
be utilizing the DEA registration of a hospital or clinic operated by
the VA registered under section 823(g).
iv. Be prescribing within the usual course of their practice and
ensure all prescribing practices are in accordance with applicable
State and Federal law(s).
The above criteria are designed to ensure that a practitioner
engaging in the practice of telemedicine is operating within their
capacity as a VA practitioner and is acting in accordance with both
applicable Federal and state law(s) and regulation(s).
B. Requirements for Previous In-Person Medical Evaluation. To be
eligible for the provisions within these regulations, an in-person
medical evaluation must have been conducted by a VA practitioner, who
at the time of the evaluation:
i. Conducted the evaluation within their official capacity as an
employee of the VA (as defined above), and
ii. The nature of the in-person medical evaluation falls within the
scope of their practice of medicine as defined in 38 CFR 17.419.
The criteria in this section establish the circumstances when a
previous in-person medical evaluation conducted by another VA
practitioner would establish the necessary relationship of care between
patient and the VA healthcare system so as to allow for use of the
telemedicine flexibilities finalized in this final rule.
C. Requirements for the Review of the VA's Internal Prescription
Database and Prescription Drug Monitoring Program. Before issuing a
telemedicine-controlled substance prescription otherwise authorized by
this final rule, the prescribing practitioner must:
i. Review both the VA patient's EHR (to include the VA's internal
prescription database) and the PDMP data of the state in which the
patient is located at the time of the telemedicine encounter for any
prescriptions of controlled substances issued to the patient and
annotate the date and time that such a review was conducted in the
patient's EHR. If either the VA's internal prescription database or the
PDMP for the state where the patient is located at the time of the
telemedicine encounter is unavailable or inaccessible for any reason,
the prescribing practitioner must annotate the date and time that such
a review was attempted in the patient's EHR and provide a reason as to
why a review was unable to be completed.
ii. The review of the VA patient's EHR (to include the VA's
internal prescription database) and state PDMP must encompass the
previous 12 calendar months, proceeding the controlled substance
prescription, of the patient's record, or if less than a year of data
is available, for the entire period of data availability.
iii. In instances where the VA patient's EHR (to include the VA's
internal prescription database) or the state PDMP for the state the
patient is located at the time of the telemedicine encounter (if the
state has such a program) are either unavailable or non-operational,
prescribing VA practitioners must limit the supply of the controlled
substance prescription to 7-days. Once access is restored to the VA
patient's EHR (to include the VA's internal prescription database) and
the PDMP, if one exists for the state where the VA patient is located
at the time of the telemedicine encounter, the prescribing practitioner
must review the relevant data prior to prescribing an additional supply
of the controlled substance, in accordance with the otherwise
applicable requirements discussed above. Additionally, the prescribing
VA practitioner must annotate the date and time that such a review was
attempted in the patient's EHR and provide a reason as to why a review
was unable to be completed. The VA practitioner may then issue a
controlled substance prescription in excess of a 7-day supply limit.
iv. If the VA patient is located in a state which does not use a
PDMP, the VA practitioner must review the patient's EHR before issuing
a prescription for controlled substances for more than a 7-day supply.
The above criteria are designed to safeguard against the risk of
diversion of controlled substances. The review of the patient's VA
medical record (to include the internal prescription database) and the
PDMP data for the state in which the patient is located gives the
prescribing VA practitioner additional insight into the patient's
prescription history of controlled substances, allowing for additional
clarity on the medical appropriateness of an additional controlled
substance prescription issued via telemedicine. Moreover, limiting the
quantity of controlled substances that can be prescribed during periods
when the either the VA patient's EHR (to

[[Page 6532]]

include the VA's internal prescription database) or the PDMP for the
state where the VA patient is located at the time of the telemedicine
encounter is unavailable provides an additional safeguard to ensure
that controlled substances are prescribed appropriately, while
preventing a lapse in care.

VI. Regulatory Analyses

Executive Orders 12866, 13563, and 14094 (Regulatory Review)

DEA and HHS have determined that this rulemaking is a ``significant
regulatory action'' under section 3(f) of Executive Order (E.O.) 12866,
Regulatory Planning and Review, but it is not a section 3(f)(1)
significant action. Accordingly, this final rule has not been submitted
to the Office of Management and Budget for review. This 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.
This final rule authorizes Department of Veterans Affairs
practitioners acting within the scope of their VA employment to
prescribe controlled substances via telemedicine to a VA patient with
whom they have not conducted an in-person medical evaluation. VA
practitioners are permitted to prescribe controlled substance
medications to VA patients if, among other things, another VA
practitioner has previously conducted an in-person medical evaluation
of the VA patient. DEA and HHS estimate the total annual cost savings
of this rule is $2.54 million due to patient travel time and cost
savings. Two million three hundred ninety thousand dollars ($2.39
million) of the cost savings is realized by the patient and $0.15
million of the cost savings is realized by the VA in form of reduced
transfers (travel reimbursements). Government benefit payments are
considered as ``transfers.'' \51\ Additionally, DEA and HHS estimate an
additional annual cost to the VA of $1.76 million due to the required
EHR and PDMP reviews. The full analysis of costs, cost savings, and
transfer savings is provided below.
---------------------------------------------------------------------------

\51\ Office of Management and Budget (OMB) Circular A-4.
---------------------------------------------------------------------------

1. Baseline
For DEA and HHS's analysis of the economic impact of this final
rule, the baseline 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.
This final rule provides:
(1) In-Person medical evaluation exemption: exempts VA
practitioners from the requirement of an in-person medical evaluation
if the patient has had a prior in-person medical evaluation from any VA
practitioner (21 CFR 1306.52(a)(3)).
(2) PDMP review: requires a PDMP review of the state in which the
patient is located, if the state has such a program (21 CFR
1306.52(b)(1)).
The costs, cost savings, and benefits associated with exempting VA
practitioners from the requirement of conducting an in-person medical
evaluation under the circumstances permitted by this rule were
evaluated from the perspective of the following impacted parties in the
following areas: patients, the VA, and the risk of diversion. Those
costs, cost savings, and benefits are discussed below.
2. Patient Costs, Cost Savings, and Benefits
This rule benefits VA patients by reducing transportation costs and
travel time costs, and by expanding access to medical care. The cost
savings associated with this rule predominantly stem from reductions in
two categories of 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 in this final 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.\52\
---------------------------------------------------------------------------

\52\ 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.\53\
---------------------------------------------------------------------------

\53\ 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.
---------------------------------------------------------------------------

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.\54\ 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
relevant for this analysis.\55\ DEA, however, acknowledges that there
may be significant variability in the average lengths of time across
different patient populations.
---------------------------------------------------------------------------

\54\ 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), https://altarum.org/travel-and-wait
(accessed 9/5/2023).
\55\ Fair Health, ``Monthly Telehealth Regional Tracker.''
https://www.fairhealth.org/fh-trackers/telehealth (accessed 8/4/2023
selecting May 2023 using National Statistics data dropdown menu).
---------------------------------------------------------------------------

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.\56\ 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.\57\ 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).

[[Page 6533]]

Therefore, the $33.58 loaded hourly wage represents the hourly average
opportunity cost to travel and wait for a practitioner's appointment.
---------------------------------------------------------------------------

\56\ Bureau of Labor Statistics, Occupational Employment and
Wages, May 2023 National Occupational Employment and Wage Estimates,
Occupation code: 00-0000 All Occupations, https://www.bls.gov/oes/2023/may/oes_nat.htm.
\57\ Bureau of Labor Statistics, Employer Costs for Employee
Compensation--June 2024, https://www.bls.gov/news.release/archives/ecec_09102024.pdf (accessed 11/13/2024).

Table 1--Patients Loaded Hourly Wage
----------------------------------------------------------------------------------------------------------------
Load for Loaded hourly
Occupation Hourly wage ($) benefits ($) 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 savings opportunity Travel and wait Cost per
cost ($) time (hours) appointment ($)
----------------------------------------------------------------------------------------------------------------
Time cost savings............................................ 33.58 0.75 25.19
----------------------------------------------------------------------------------------------------------------

b. Patient's Net Cost of Travel per Practitioner Visit
DEA estimates there will be cost savings to VA patients as a result
of not having to travel to a VA practitioner for a visit. The patient's
net cost of travel is the cost of travel net of reimbursements received
from the VA. 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.\58\ Using the
IRS travel reimbursement rate for businesses of 67 cents per mile as an
estimate of travel cost,\59\ the estimated patient's cost of travel to
and from a practitioner's appointment is $13.27 ($0.67 x 19.8), as can
be seen in table 3 below.
---------------------------------------------------------------------------

\58\ 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. https://srhrc.tamu.edu/publications/travel-burdens-07.2021.pdf. https://ofm.wa.gov/sites/default/files/public/legacy/researchbriefs/2013/brief070.pdf (accessed 9/24/2024)
\59\ Internal Revenue Service. Standard Mileage Rates, Notice
2024-08, https://www.irs.gov/pub/irs-drop/n-24-08.pdf (accessed 10/
18/2024).

Table 3--Patient Travel Cost per Trip
----------------------------------------------------------------------------------------------------------------
Travel cost per Travel distance Per appointment
Cost savings mile ($) (miles) cost ($)
----------------------------------------------------------------------------------------------------------------
Patient travel cost.......................................... 0.67 19.8 13.27
----------------------------------------------------------------------------------------------------------------

The VA reimbursement rate is $0.415 per mile for approved, health-
related travel, with a current deductible of $6 round-trip for each
appointment, up to $18 total each month.\60\ Assuming VA patients
generally do not reach the $18 monthly deductible limit, the estimated
VA mileage reimbursement is $8.22 ($0.415 x 19.8) per visit. After a $6
deductible, the net VA reimbursement after deductible is $2.22 ($8.22 -
$6) and the patient's net cost of travel is $11.05 ($13.27 - $2.22).
Table 4 summarizes the VA reimbursement and patient's net cost of
travel.
---------------------------------------------------------------------------

\60\ U.S. Department of Veterans Affairs, Reimbursed VA travel
expenses and mileage rate, https://www.va.gov/resources/reimbursed-va-travel-expenses-and-mileage-rate/ (accessed 11/12/2024).

Table 4--VA Reimbursement and Patient Net Travel Cost per Trip
----------------------------------------------------------------------------------------------------------------
Travel Per
Travel cost distance appointment
per mile ($) (miles) cost ($)
----------------------------------------------------------------------------------------------------------------
VA mileage reimbursement per trip............................... 0.415 19.8 8.22
Deductible (paid by patient).................................... N/A N/A 6.00
Net VA mileage reimbursement per trip........................... N/A N/A 2.22
Patient net travel cost per trip................................ N/A N/A 11.05
----------------------------------------------------------------------------------------------------------------

[[Page 6534]]

c. Total Number of Telemedicine Visits
This final rule's patient cost savings results from eliminating the
need for an in-person medical evaluation or visit. Subsequent
telemedicine visits are allowed after that initial in-person medical
evaluation or visit, even without the COVID-19 PHE telemedicine
flexibilities. So, to calculate the total patient cost savings under
this rule, DEA needed to estimate the total number of first-time
telemedicine visits resulting in prescriptions for controlled
substances.\61\ Given the absence of direct information on this point,
however, it was necessary for DEA to perform a multi-step analysis or
derivation using different available data sources at each step to
derive an estimate. First, the number of practitioner visits conducted
via telemedicine was reduced to those that constituted first-time
telemedicine visits. Second, DEA determined the proportion of the
first-time telemedicine visits that would result in prescriptions.
Third, it refined the total number of first-time telemedicine visits
resulting in prescriptions of controlled substances. And lastly, DEA
considered the impact of the rule's requirements and determined the
total number of first-time telemedicine visits resulting in
prescriptions of controlled substances under this rule. DEA performed
this multi-step analysis to derive an estimate of the number of first-
time telemedicine visits resulting in prescriptions for controlled
substances, which resulted in an estimate of the current value for the
total patient cost savings.
---------------------------------------------------------------------------

\61\ Total Patient Cost Savings = (number of first-time
telemedicine visits resulting in prescriptions for controlled
substances) * (patient cost savings).
---------------------------------------------------------------------------

Step 1: First-Time Visits. Based on a VHA 2023 annual report there
were over 9.4 million telehealth encounters to veterans in the home or
other offsite locations.\62\ DEA needed to further refine the total
number of telemedicine practitioner visits to those that constituted
first-time telemedicine visits. DEA's focus on first-time telemedicine
practitioner visits, rather than all telemedicine visits, was to
prevent an overestimation of the total patient cost savings. Under the
status quo, after one bona fide in-person medical evaluation, patients
are typically permitted to be seen via telehealth thereafter when
receiving prescriptions for controlled substances. A potential
overestimate of total patient cost savings arises from the fact that
patient cost savings under this rule primarily hinge on the bypassing
of a first-time, in-person medical evaluation, but not subsequent
telemedicine visits.
---------------------------------------------------------------------------

\62\ VHA. VHA 2023 Annual Report. https://department.va.gov/vha-annual-report/ (accessed 10/12/2024).
---------------------------------------------------------------------------

A 2022 study analyzing trends between 2017-2020 in interstate
telehealth use by Medicare beneficiaries, a subset of the population
impacted by this rule, shows that the vast majority of practitioner
visits are for returning patients, and approximately 10 percent of
those practitioner visits are new visits.\63\ This is in line with the
Center for Disease Control and Prevention's (CDC) 2019 National
Ambulatory Medical Care (NAMC) non-Federal survey where 16.8 percent of
office visits were for new patients. The CDC's 2019 NAMC survey,
however, was not limited to telehealth visits, so DEA decided that the
10 percent estimate from the 2022 interstate telehealth study was more
applicable to this analysis.\64\ Taking 10 percent of 9,400,000
practitioner visits conducted via telemedicine would provide a total of
approximately 940,000 first-time, telemedicine practitioner visits, as
can be seen in table 5.
---------------------------------------------------------------------------

\63\ Andino, J.J., Zhu, Z., Surapaneni, M., Dunn, R. L., &
Ellimoottil, C. (2022). Interstate Telehealth Use by Medicare
Beneficiaries Before and After COVID-19 Licensure Waivers, 2017-20.
Health Affairs, 41(6). Appendix Exhibit 1 show that in person level
3 and level 4 new visits are 6.8% (3.5% + 3.3%) and out-of-state new
visits are 10.7% (5.6% + 5.1%).
\64\ U.S. Department of Health and Human Services, Centers for
Disease Control and Prevention, National Center for Health
Statistics (2019). National Ambulatory Medical Care Survey: 2019
National Summary Tables. Retrieved from https://www.cdc.gov/nchs/data/ahcd/namcs_summary/2019-namcs-web-tables-508.pdf.

Table 5--Number of First-Time Telemedicine Visits
------------------------------------------------------------------------

------------------------------------------------------------------------
Telemedicine visits......................................... 9,400,000
First-time telemedicine visit rate.......................... 0.1
First-time telemedicine visits.............................. 940,000
------------------------------------------------------------------------

Step 2: Visits Resulting in Prescriptions. DEA needed to determine
the fraction of first-time telemedicine visits that would result in
prescriptions. Looking again at CDC's 2019 NAMC survey, DEA determined,
as reflected in table 6, that 291,394,000 visits did not include any
prescribing, which means 745,090,000 of the 1,036,484,000 visits, or
approximately 72 percent of the visits, did in fact result in the
issuance of prescriptions. Because only 72 percent of visits resulted
in a prescription, DEA applied the 72 percent to the calculated 940,000
first-time, telemedicine visits resulting in approximately a total of
676,800 first-time telemedicine visits resulting in the issuance of
prescriptions, as can be seen in table 7.

Table 6--Estimate of Number of Prescriptions Using Visit Data
------------------------------------------------------------------------
Number of Total number of
Number of prescriptions visits prescriptions
(thousands) (thousands)
------------------------------------------------------------------------
0................................... 291,394 ..................
1................................... 192,488 192,488
2................................... 129,561 259,122
3................................... 84,898 254,694
4................................... 60,766 243,064
5................................... 52,613 263,065
6................................... 34,041 204,246
7................................... 28,900 202,300
8................................... 29,043 232,344
9................................... 23,393 210,537
10.................................. 15,320 153,200
11.................................. 17,034 187,374
12.................................. 14,744 176,928
13.................................. 13,419 174,447
14.................................. 10,635 148,890

[[Page 6535]]

15+................................. 38,236 * 573,540
-----------------------------------
Total........................... ** 1,036,485 3,476,239
------------------------------------------------------------------------
* Used 15 as an approximation for 15+.
** The published total shows 1,036,484, so there is a rounding error of
1.

Table 7--Estimate of Number of First-Time Telemedicine Visits With
Prescriptions
------------------------------------------------------------------------

------------------------------------------------------------------------
First-time telemedicine visits........ ............... 940,000
NAMC survey visits--total............. 1,036,484,000 ...............
NAMC survey visits--0 prescriptions... 291,394,000 ...............
NAMC survey rate--0 prescriptions..... 0.28 ...............
NAMC survey rate--with prescriptions.. 0.72 0.72
First-time telemedicine visits with ............... 676,800
prescriptions........................
------------------------------------------------------------------------

Step 3: Prescriptions for Controlled Substances. DEA then refined
the total number of first-time telemedicine visits resulting in
prescriptions for controlled substances. According to the Federal Trade
Commission (FTC), Surescripts has 95% market share in e-prescribing
services as of 2023.\65\ DEA was able to use 2021 data from the
Surescripts National Progress Report to determine that approximately 16
percent of all prescriptions (paper and electronic) are for controlled
substances.\66\ Applying this 16 percent to the total number of 676,800
telemedicine visits resulting in the issuance of prescriptions,
provides a value of approximately 108,288 first-time telemedicine
visits resulting in prescriptions for controlled substances, as can be
seen in table 8.
---------------------------------------------------------------------------

\65\ FTC Reaches Proposed Settlement with Surescripts in Illegal
Monopolization Case Federal Trade Commission (July 27, 2023),
https://www.ftc.gov/news-events/news/press-releases/2023/07/ftc-reaches-proposed-settlement-surescripts-illegal-monopolization-case
(accessed 9/24/2024).
\66\ According to the Surescripts National Progress Report,
there were 256.9 million prescriptions of controlled substances
prescribed through EPCS, accounting for 73 percent of the total
number of prescriptions of controlled substances. Using these
figures, DEA derived the total number of prescriptions of controlled
substances to be 351.9 million ((256.9 million) * (100)/(73) = 351.9
million). There were 2.12 billion prescriptions of controlled
substances and non-controlled substances prescribed electronically,
accounting for 94 percent of the total number of all prescriptions
paper or electronic for controlled substances or non-controlled
substances. DEA derived the total number of all prescriptions paper
or electronic for controlled substances or non-controlled substances
to be 2.26 billion ((2.12 billion) * (100)/(94) = 2.26 billion).
Using the total of all controlled substances prescriptions (351.9
million) and the total of all prescriptions (2.26 billion), DEA
determined that 16% of all prescriptions are for controlled
substances ((256.9 million) * (100)/2.26 billion = 16 percent).

Table 8--Current Estimate of Number of First-Time Telemedicine Visits
Resulting in Prescriptions of Controlled Substances
------------------------------------------------------------------------

------------------------------------------------------------------------
First-time telemedicine visits with prescriptions....... 676,800
Controlled substance (CS) rate.......................... 0.16
First-time telemedicine visits with CS prescriptions.... 108,288
------------------------------------------------------------------------

Step 4: Effect of this Rule. Lastly, DEA determined the total
number of first-time telemedicine visits resulting in prescriptions of
controlled substances under this rule. Under this final rule, patients
would not have an in-person follow-up visit after the first-time
telemedicine visit; they would never have to see the prescribing
practitioner in person. Based on a study by Epic Research of primary
care visits between March 1, 2020 and October 15, 2022, 61 percent of
telehealth visits did not require an in-person follow-up.\67\ A similar
study by Epic Research on specialty visits provided that 85 percent of
mental health and psychiatry telehealth visits did not have an in-
person follow-up visit.\68\ Because this rule is not limited to mental
health, DEA applied the broader and lower 61 percent to the 108,288
first-time telemedicine visits resulting in prescriptions of controlled
substances. The multi-step analysis ultimately derived a current
estimate of 66,056 first-time telemedicine visits resulting in
prescriptions of controlled substances under this rule, as can be seen
in table 9.
---------------------------------------------------------------------------

\67\ Gerhart J, Piff A, Bartelt K, Barkley E. Most Primary Care
Telehealth Visits Unlikely to Need In-Person Follow-Up. Epic
Research. https://www.epicresearch.org/articles/most-primary-care-telehealth-visits-unlikely-to-need-in-person-follow-up (accessed 10/
20/2024).
\68\ Gerhart J, Piff A, Bartelt K, Barkley E. Telehealth Visits
Unlikely to Require In-Person Follow-Up Within 90 Days. Epic
Research. https://epicresearch.org/articles/telehealth-visits-unlikely-to-require-in-person-follow-up-within-90-days (accessed 10/
20/2024).

[[Page 6536]]

Table 9--Current Estimate of Number of First-Time Telemedicine Visits Resulting in Prescriptions of Controlled
Substances Under This Rule
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
Telemedicine visits..................................... 9,400,000 ............... ........... ...........
First time telemedicine visit rate...................... 0.1 ............... ........... ...........
First-time telemedicine visits.......................... 940,000 ............... 940,000 ...........
NAMC survey visits--total............................... ........... 1,036,484,000 ........... ...........
NAMC survey visits--0 prescriptions..................... ........... 291,394,000 ........... ...........
NAMC survey rate--0 prescriptions....................... ........... 0.28 ........... ...........
NAMC survey rate--with prescriptions.................... ........... 0.72 0.72 ...........
First-time telemedicine visits with prescriptions....... ........... ............... 676,800 676,800
Controlled substance (CS) rate.......................... ........... ............... ........... 0.16
First-time telemedicine visits with CS prescriptions.... ........... ............... ........... 108,288
First-time telemedicine visits that do not have an in- ........... ............... ........... 0.61
person follow up visit.................................
First-time telemedicine visits under this rule with CS ........... ............... ........... 66,056
prescriptions..........................................
----------------------------------------------------------------------------------------------------------------

d. Total Patient Cost Savings
Each telemedicine visit saves patients time and travel costs of
$25.19 and $13.27, respectively, for a total savings of $38.46.
Applying the cost savings of $38.46 to the estimated number of first-
time telemedicine visits under the proposed rule with controlled
substance prescriptions results in a total patient cost savings of
$2,540,514 ($38.46 x 66,056) per year.
Additionally, from table 4, DEA estimates VA will reimburse the
patient $2.22 per trip. Applying this reimbursement amount to the
number of trips, the VA reimbursement amount (transfers to the patient)
is $146,644 ($2.22 x 66,056). Subtracting the VA reimbursement amount
from the total cost savings, DEA estimates a total patient net cost
savings of $2,393,870 ($2,540,514 - $146,644) per year. Table 10
summarizes this calculation.

Table 10--Total Cost/Transfer Savings
----------------------------------------------------------------------------------------------------------------
Patient net
Total cost VA reimbursement cost savings
savings ($) ($) ($)
----------------------------------------------------------------------------------------------------------------
Patient cost savings (per visit)............................. 38.46 2.22 N/A
Patient cost savings......................................... 2,540,514 146,644 2,393,870
----------------------------------------------------------------------------------------------------------------

e. Patient Benefit: Increased Access to Care
While DEA estimated the patient cost savings for the estimated
66,056 patient visits that would fall under this final rule, DEA is
unable to quantify the number of patients that will be treated that
would not have been treated absent this regulation. In recent years,
telemedicine has emerged as a vital solution for enhancing healthcare
accessibility for VA patients, especially in the face of healthcare
shortages. Notably, telemedicine extends its benefits to patients in
remote and other underserved areas, including by offering access to
specialized care. While DEA is unable to quantify the number of
patients that will be treated that would not have been treated absent
this regulation, it is reasonable to assume there will be VA patients
that will fall in this category and the benefits of increased access to
care are not negligible.
3. VA Costs and Transfer Savings
Impact on the VA is primarily due to two primary factors,
additional burden for VA patient EHR and PDMP reviews prior to
prescribing and reduced travel reimbursements to VA patients.
Prior to prescribing, the practitioner must conduct a review of
both the patient's VA medical record, to include in the VA's internal
prescription database, and the PDMP of the state in which the patient
is located at the time of the telemedicine encounter (if the State has
such a program) for controlled substance prescription(s) for the
patient's previous twelve (12) months preceding the controlled
substance prescription(s), or if less than a year of data is available,
for the entire prescription period. Additionally, the VA practitioner
must annotate in the VA patient's EHR their attempts to obtain the PDMP
of the state in which the patient is located and VA internal
prescription database data. DEA estimated the cost of this requirement
by estimating the cost per review and applying the cost to the number
of patient visits.
Based on the BLS wage data, DEA estimated the cost per review for
physicians, nurse practitioners (NPs), and physician's assistants
(PAs), then calculated a weighted average cost per review based on the
number of physicians, NPs, and PAs.\69\
---------------------------------------------------------------------------

\69\ Bureau of Labor Statistics, Occupational Employment and
Wages, May 2023 National Occupational Employment and Wage Estimates,
https://www.bls.gov/oes/2023/may/oes_nat.htm (accessed 10/18/2024).
The following occupation codes were used: 29-1210 Physicians and 29-
1240 Surgeons (for ``physician''), 29-1171 Nurse Practitioners, and
29-1071 Physician Assistants.
---------------------------------------------------------------------------

The mean wage data for physicians is $129.71 and the median wage
for PAs and NPs are $62.51 and $60.70, respectively.\70\ 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.\71\ The load of 45.3 percent is added to wages and salaries
by multiplying the wages and salaries by 1.453 (1 + 0.453). The
resulting loaded hourly rates are $188.47 ($129.71 x 1.453), $90.83
($62.51 x 1.453), and $88.20 ($60.70 x 1.453), for physicians, PAs, and
NPs, respectively.
---------------------------------------------------------------------------

\70\ Id. (Weighted average of mean hourly wages for 29-1210
Physicians and 29-1240 Surgeons. Used ``mean'' hourly wages because
``median'' was not available.)
\71\ Bureau of Labor Statistics, Employer Costs for Employee
Compensation--March 2023, https://www.bls.gov/news.release/archives/ecec_06162023.pdf (accessed 9/24/2024).
---------------------------------------------------------------------------

Based on a 2018 study, it takes a practitioner 27 seconds to log in
and 37 seconds to retrieve a report once logged

[[Page 6537]]

in.\72\ The total time it takes to retrieve a PDMP report is roughly a
minute (27 + 37 = 64 seconds) or 0.017 (1/60) hours. Applying 0.017
hours to the loaded hourly rates, the estimated labor cost to complete
the review for physicians is $3.20 ($188.47 x 0.017), for physician
assistants is $1.54 ($90.83 x 0.017), and for nurse practitioners is
$1.50 ($88.20 x 0.017). Table 11 summarizes the results.
---------------------------------------------------------------------------

\72\ Bachhuber MA, Saloner B, LaRochelle M, Merlin JS, Maughan
BC, Polsky D, Shaparin N, Murphy SM. Physician Time Burden
Associated with Querying Prescription Drug Monitoring Programs. Pain
Med. 2018 Oct.

Table 11--EHR and PDMP Check Time Cost
----------------------------------------------------------------------------------------------------------------
Hourly wage Load for Loaded hourly PDMP check Cost per PDMP
Occupation ($) benefits ($) wage ($) time (hours) check ($)
----------------------------------------------------------------------------------------------------------------
Physicians...................... 129.71 58.76 188.47 0.017 3.20
Physician Assistant............. 62.51 28.32 90.83 0.017 1.54
Nurse Practitioners............. 60.70 27.50 88.20 0.017 1.50
----------------------------------------------------------------------------------------------------------------

As of October 19, 2024, DEA estimates there were 15,148 physicians,
5,351 NPs, and 1,513 PAs registered with DEA that meet the VA
employment requirements of this final rule.\73\ For simplicity, DEA
calculated a single cost of a review based on the weighted average of
the three occupations. The weighted average of the cost of review is
$2.67. Table 12 details the calculation.
---------------------------------------------------------------------------

\73\ DEA estimate based on registrations.

Table 12--EHR PDMP Check Time Cost
----------------------------------------------------------------------------------------------------------------
Weighted cost
Occupation VA registrants VA registrant Cost per PDMP per PDMP check
weights check ($) ($)
----------------------------------------------------------------------------------------------------------------
Physicians..................................... 15,148 0.6882 3.20 2.20
Physician Assistant............................ 1,513 0.0687 1.54 0.11
Nurse Practitioners............................ 5,351 0.2431 1.50 0.36
----------------------------------------------------------------
Total...................................... 22,012 N/A N/A 2.67
----------------------------------------------------------------------------------------------------------------

As discussed earlier in table 9, DEA estimates that annually, there
will be 66,056 first time telemedicine patient visits, which are
patients visiting a specific practitioner for the first time, that
result in a prescription for a controlled substances that fall under
this final rule. However, unlike patient travel time and cost savings,
since the EHR and PDMP reviews are required for all visits and not just
first-time visits, there will not be a first-time visit adjustment.
While EHR and PDMP reviews will be required for all prescriptions under
this rule, DEA believes PDMP checks are already conducted in most
cases, lowering the additional burden imposed by this rule. However, to
be conservative, DEA applied the full cost of $2.67 to all telemedicine
visits leading to a prescription by backing out the 0.1 factor applied
for first-time visits (table 9), in other words, by multiplying the
number of first-time telemedicine visits (66,056) by 10 for 660,560
total visits. Applying the cost of $2.67 to the total number of visits
results in a total cost of $1,763,695 ($2.67 x 660,560) per year.
As discussed earlier in table 10, DEA estimates the VA will save
$146,644 annually from reduced travel reimbursements to patients.
While there may be reduced costs to the VA as a result of fewer
patient visits to its facilities, for the purposes of this analysis,
DEA and HHS anticipate that there will be no significant net economic
impact on the VA's healthcare systems due to the rule. According to one
peer-reviewed medical journal article from 2020, telehealth is expected
to reduce costs in health systems between 32 percent to 53 percent of
the time.\74\
---------------------------------------------------------------------------

\74\ Snoswell CL, Taylor ML, et al. Determining if Telehealth
Can Reduce Health System Costs: Scoping Review. J Med Internet Res.
October 2020.
---------------------------------------------------------------------------

However, evidence suggests that it does not routinely reduce the
cost of care delivery for the health system as a whole.\75\ A more
recent 2023 study, focused on payment analysis for telehealth and in-
person care, comes to a similar conclusion, noting the lack of cost
differential and concluding that the primary benefit of telehealth is
increased access and convenience, not cost savings.\76\
---------------------------------------------------------------------------

\75\ Id.
\76\ Amin K, Rae M, et al. Early in the pandemic, private
insurer payments for telehealth and in-person claims were similar.
Peterson-KFF Health System Tracker. January 18, 2023. https://www.healthsystemtracker.org/brief/telehealth-payments-similar-early-in-the-pandemic/#Average%20payment%20for%20evaluation%20and%20management%20professional%20claims%20by%20telehealth%20and%20in-person,%20among%20privately%20insured,%202020 (accessed 9/5/2023).
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4. Risk of Diversion
Requiring an in-person medical evaluation serves as a safeguard
against diversion, consistent with the Ryan Haight Act. Since the
advancement of telemedicine technology, new diversion paradigms have
emerged in telemedicine.\77\ Therefore, to address new ways of
delivering care, DEA believes that other anti-diversion safeguards--
such as those in this final rule--are necessary, beyond the measures
that have been in place since March 2020, to address the ongoing risks
of diversion.
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\77\ See, e.g., 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), https://www.justice.gov/opa/pr/founderceo-and-clinical-president-digital-health-company-arrested-100m-adderall-distribution.
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Admittedly, there is little quantified data on diversion since the
onset of the COVID-19 pandemic. However, Dea is

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concerned that the intentionally concealed and frequently underreported
nature of drug diversion makes these illicit activities inherently
difficult to track.\78\ By design, illegal activities like diversion
are meant to evade detection, which complicates the collection of
comprehensive and reliable quantitative data. Furthermore, diversion of
controlled substances can take on many forms, from theft and fraud to
improper prescribing making it difficult to quantify in a standardized
method.
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\78\ In some comments to the March 2023 NPRMs and during some of
the presentations during the Telemedicine Listening Sessions,
individuals cited studies demonstrating a lack of increased
proportion of overdose deaths involving buprenorphine during the
initial months of the pandemic, when the telemedicine flexibilities
were first put in place, as evidence of a lack of diversion of
controlled substances more generally. However, it is important to
note that these studies focused solely on buprenorphine, and it
would be inappropriate to extrapolate their findings to all
controlled substances given the unique characteristics of
buprenorphine, particularly the combination buprenorphine product
(Suboxone), which adds naloxone designed to deter diversion and
misuse. Consistent with this data, buprenorphine has been provided
unique treatment under this rule and under the separate Expansion of
Buprenorphine Treatment via Telemedicine Encounter final rule (RIN
1117-AB78), published elsewhere in this issue of the Federal
Register. See, e.g., Tanz LJ, Jones CM, Davis NL, Compton WM,
Baldwin GT, Han B, Volkow ND. Trends and Characteristics of
Buprenorphine-Involved Overdose Deaths Prior to and During the
COVID-19 Pandemic. JAMA Netw Open. 2023 Jan 3;6(1): e2251856. doi:
10.1001/jamanetworkopen.2022.51856. PMID: 36662523; PMCID:
PMC9860517; and Sade E. Johns, Mary Bowman, F. Gerard Moeller,
Utilizing Buprenorphine in the Emergency Department after Overdose,
Trends in Pharmacological Sciences, Volume 39, Issue 12, (2018),
https://doi.org/10.1016/j.tips.2018.10.002, available: https://www.sciencedirect.com/science/article/pii/S0165614718301809.
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Given the dearth of comprehensive standardized data on diversion,
DEA has had to rely on qualitative information and insights, such as
anecdotal information, expert testimony from industry, and the
specialized experience and knowledge of DEA's diversion investigators
to identify emerging trends and inform enforcement strategies. Under
this rule, DEA is requiring prescribers to review patient records and
check PDMPs prior to prescribing controlled substances. DEA believes
the requirements of this rule and the VA's internal safeguards will
adequately manage the risk of diversion. DEA and HHS would like to
protect and advance access to care for Veterans. Accordingly, this
final rule will help to advance access to care while protecting against
potential diversion risk.
5. Summary of Economic Impact
DEA and HHS estimate the total annual cost savings of this final
rule is $2.54 million due to patient travel time and cost savings.
$2.39 million of the cost savings is realized by the patient and $0.15
million of the cost savings is realized by the VA in form of reduced
transfers (travel reimbursements). Additionally, DEA and HHS estimates
an additional annual cost to the VA of $1.76 million due to the
required EHR and PDMP reviews.
DEA believes that the benefits of increased availability for
treatment outweigh the dangers of a potential increase in diversion, so
long as VA practitioners adhere to the anticipated safeguards VA and/or
DEA will implement or have already implemented with respect to the
practice of telemedicine.

Regulatory Flexibility Act

The Administrator of DEA, in accordance with the Regulatory
Flexibility Act (5 U.S.C. 601-612) (RFA), has reviewed this rule and by
approving it certifies that it will not have a significant economic
impact on a substantial number of small entities.
This final rule affects the VA and its individual patients. The VA
is not a small entity. Therefore, this rule will not have significant
economic impact on a substantial number of small entities.

Paperwork Reduction Act of 1995

This action would not create or modify a collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.)
(PRA). An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. PRA is not applicable when the
information is being collected from Federal employees or contractors as
a part of their job. In this final rule, all recordkeeping actions are
taken by Federal employees as a part of their work-related duties with
the VA.

Executive Order 12988, Civil Justice Reform

This final rule meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of E.O. 12988 to eliminate drafting errors
and ambiguity, minimize litigation, provide a clear legal standard for
affected conduct, and promote simplification and burden reduction.

Executive Order 13132, Federalism

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

Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments

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

Unfunded Mandates Reform Act of 1995

The estimated annual impact of this final rule is minimal. Thus,
DEA has determined in accordance with the Unfunded Mandates Reform Act
of 1995 (UMRA) (2 U.S.C. 1501 et seq.) that this action would not
result in any Federal mandate that may result in the expenditure by
State, local, and Tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted for inflation) in any
one year. Therefore, neither a Small Government Agency Plan nor any
other action is required under provisions of UMRA.

Congressional Review Act

Pursuant to Subtitle E of the Small Business Regulatory Enforcement
Fairness Act of 1996 (also known as the Congressional Review Act), the
Office of Information and Regulatory Affairs has determined that this
rule does not meet the criteria set forth in 5 U.S.C. 804(2). DEA will
submit a copy of this final rule to both Houses of Congress and to the
Comptroller General.

List of Subjects

21 CFR Part 1306

Administrative practice and procedure, Drug traffic control,
Prescription drugs, Reporting and recordkeeping requirements.

42 CFR Part 12

Administrative practice and procedure.

Signing Authority

This document of the Drug Enforcement Administration was signed on
January 13, 2025, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for

[[Page 6539]]

publication, as an official document of DEA. This administrative
process in no way alters the legal effect of this document upon
publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
Miriam E. Delphin-Rittmon,
Assistant Secretary for Mental Health and Substance Use, Department of
Health and Human Services.

Drug Enforcement Administration

For the reasons set out above, the Drug Enforcement Administration
amends 21 CFR part 1306 as follows:

PART 1306--PRESCRIPTIONS

0
1. The authority citation for part 1306 continues to read as follows:

Authority: 21 U.S.C. 821, 823, 829, 829a, 831, 871(b) unless
otherwise noted.

0
2. Add Sec. 1306.52 to read as follows:

Sec. 1306.52 Other circumstances where Department of Veterans Affairs
practitioners may prescribe controlled substances via the practice of
telemedicine.

A practitioner may prescribe controlled substance(s) to a patient
via the practice of telemedicine under Sec. 1300.04(i)(7) of this
chapter if all the following conditions are met:
(a) The practitioner is:
(1) An employee or contractor of the Department of Veterans Affairs
(VA) who is acting in the scope of such employment or contract, and
registered under section 303(g) of the Act (21 U.S.C. 823(g)) (Sec.
1301.13 of this chapter) in any state or is utilizing the registration
of a hospital or clinic operated by the VA registered under section
303(f);
(2) Prescribing to a VA patient who has previously received, at any
time, an in-person medical evaluation by any VA practitioner who at the
time of the in-person medical evaluation was acting within the scope of
their VA employment or contract and had prescribing authority, or would
reasonably be expected to have prescribing authority based on their
credentials (e.g., medical doctor) or organizational role (e.g.,
primary care provider), as described in paragraph (a)(1) of this
section;
(3) Not a contracted practitioner located outside a VA facility or
clinic providing care via the community care network or conducting
disability compensation evaluations; and
(4) Prescribing a controlled substance(s) for a legitimate medical
purpose in the usual course of professional practice, and in accordance
with applicable Federal and State law(s).
(b) Prior to prescribing, the practitioner must conduct a review of
both the VA EHR, to include the VA's internal prescription database,
and the PDMP data of the state in which the patient is located at the
time of the telemedicine encounter (if the state has such a program)
for controlled substance prescription(s) for the patient's previous
twelve (12) months preceding the controlled substance prescription(s),
or if less than a year of data is available, for the entire
prescription period.
(1) Should either the patient's VA electronic health record, to
include the VA's internal prescription database, or the PDMP of the
state in which the patient is located at the time of the telemedicine
encounter (if the state has such a program) be unavailable or non-
operational, for any reason, the VA practitioner must limit the
prescription to a 7-day supply. Once the VA's internal prescription
database and the PDMP are available or operational, a review of the
databases as outlined in this paragraph (b) must be completed to
continue prescribing the controlled substance(s) to the VA patient.
(2) If no PDMP exists in the state in which the patient is located
at the time of the telemedicine encounter, the VA practitioner must
review the VA internal prescription database prior to issuing a
controlled substance prescription. A prescription may extend beyond 7
days under this circumstance.
(3) The VA practitioner must annotate in the VA patient's EHR their
attempts to access the PDMP data of the state in which the patient is
located, and VA internal prescription database data. If no PDMP exists
in the state in which the patient is located at the time of the
telemedicine encounter, the prescribing practitioner must annotate that
in the VA patient's EHR. If the prescribing VA practitioner fails to
access the PDMP data of the state in which the patient is located or VA
internal prescription database data as described in paragraph (b)(1) of
this section, the VA practitioner must annotate in the VA patient's EHR
the dates and times that the VA practitioner attempted to gain access,
the reason why the VA practitioner was unable to gain access, and any
follow-up attempts made to gain access to the system. The attempts must
be recorded in accordance with the VA's internal policies and
recordkeeping requirements.
(c) The controlled substance prescription(s) must be otherwise in
conformity with the requirements of the Controlled Substances Act and
this chapter.

Department of Health and Human Services

For the reasons set out above, the Department of Health and Human
Services amends 42 CFR part 12 as follows:

PART 12--TELEMEDICINE FLEXIBILITIES

0
3. The authority citation for part 12 continues to read as follows:

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

0
4. Add Sec. 12.4 to read as follows:

Sec. 12.4 Telemedicine prescribing of schedule II-V medications by
the Department of Veterans Affairs practitioners.

A practitioner may prescribe controlled substance(s) to a patient
via the practice of telemedicine under 21 CFR 1300.04(i)(7) if all the
following conditions are met:
(a) The practitioner is:
(1) An employee or contractor of the Department of Veterans Affairs
(VA) who is acting in the scope of such employment or contract, and
registered under section 303(g) of the Controlled Substances Act (Act)
(21 U.S.C. 823(g)) (21 CFR 1301.13) in any state or is utilizing the
registration of a hospital or clinic operated by the VA registered
under section 303(f);
(2) Prescribing to a patient who has previously received, at any
time, an in-person medical evaluation by any VA practitioner who at the
time of the in-person medical evaluation was acting within the scope of
their VA employment or contract and had prescribing authority, or would
reasonably be expected to have prescribing authority based on their
credentials (e.g., medical doctor) or organizational role (e.g.,
primary care provider), as described in paragraph (a)(1) of this
section;
(3) Not a contracted practitioner located outside a VA facility or
clinic providing care via the community care network or conducting
disability compensation evaluations; and
(4) Prescribing a controlled substance(s) for a legitimate medical
purpose in the usual course of professional practice, and in accordance
with applicable Federal and State law(s).
(b) Prior to prescribing, the practitioner must conduct a review of
both the VA EHR, to include the VA's internal prescription database,
and the PDMP data of the state in which the patient is located at the
time of the

[[Page 6540]]

telemedicine encounter (if the state has such a program) for controlled
substance prescription(s) for the patient's previous twelve (12) months
preceding the controlled substance prescription(s), or if less than a
year of data is available, for the entire prescription period.
(1) Should either the patient's VA electronic health record, to
include the VA's internal prescription database, or the PDMP data of
the state in which the patient is located at the time of the
telemedicine encounter (if the state has such a program) be unavailable
or non-operational, for any reason, the VA practitioner must limit the
prescription to a 7-day supply. Once the VA's internal prescription
database and the PDMP are available or operational, a review of the
databases as outlined in this paragraph (b) must be completed to
continue prescribing the controlled substance(s) to the VA patient.
(2) If no PDMP exists in the state in which the patient is located
at the time of the telemedicine encounter, the VA practitioner must
review the VA internal prescription database prior to issuing a
controlled substance prescription. A prescription may extend beyond 7
days under this circumstance.
(3) The VA practitioner must annotate in the VA patient's EHR their
attempts to access the PDMP data of the state in which the patient is
located, and VA internal prescription database data. If the prescribing
VA practitioner fails to access the PDMP data of the state in which the
patient is located or VA internal prescription database data as
described in paragraph (b)(1) of this section, the VA practitioner must
annotate in the VA patient's EHR the dates and times that the VA
practitioner attempted to gain access, the reason why the VA
practitioner was unable to gain access, and any follow-up attempts made
to gain access to the system. The attempts must be recorded in
accordance with the VA's internal policies and recordkeeping
requirements.
(c) The controlled substance prescription(s) is otherwise in
conformity with the requirements of the Act and 21 CFR chapter II.

[FR Doc. 2025-01044 Filed 1-15-25; 8:45 am]
BILLING CODE 4410-09-P