`[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.
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    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.
---------------------------------------------------------------------------

    \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

[[Page 6538]]

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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`