Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 6523 

1 88 FR 12875 (Mar. 1, 2023). 

Services amends 42 CFR part 12 as 

follows: 

PART 12—TELEMEDICINE 

FLEXIBILITIES 

■ 4. The authority citation for part 12 

continues to read as follows: 

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

■ 5. Add subpart B to read as follows: 

Subpart B—Telemedicine Prescribing 

§ 12.3 Telemedicine prescribing of 

schedule III–V medications for the treatment 

of Opioid Use Disorder. 

(a) For purposes of this section, terms 

defined in 21 CFR part 1300, elsewhere 

in 21 CFR chapter II, or in 21 U.S.C. 802 

and 829 shall have the definitions set 

forth therein. 

(b) A practitioner may issue a 

prescription for schedule III–V 

controlled substances listed in 42 CFR 

8.12(h)(2) as approved by the Food and 

Drug Administration (FDA) for use in 

the treatment of Opioid Use Disorder 

(OUD), defined as the use of an effective 

medication such as buprenorphine to 

treat OUD, pursuant to a 

communication between the prescribing 

practitioner and the patient using an 

interactive telecommunications system, 

including an audio-only 

telecommunications system, as 

described in 42 CFR 410.78(a)(3), if the 

following conditions are met: 

(1) Prescription drug monitoring 

program review. The prescribing 

practitioner must be authorized to 

access the applicable prescription drug 

monitoring program (PDMP) data of the 

state in which the patient is located at 

the time of the telemedicine encounter. 

The prescribing practitioner shall 

review such data regarding any 

controlled medication prescriptions 

issued to the patient in the last year, or, 

if less than one year of data is available, 

in the entire available period. The 

prescribing practitioner shall ensure the 

date and time of such a review is 

annotated in the patient’s electronic 

health record (EHR) or paper record. 

This review, or attempted review, must 

be conducted prior to issuing a 

prescription in a manner authorized 

under this section. 

(2) Time limit. The practitioner may 

issue prescriptions to the patient 

pursuant to this section for a period not 

to exceed six calendar months 

beginning on the date the first 

prescription is issued. The practitioner 

may issue additional prescriptions to 

the patient for schedule III–V controlled 

substances approved by the FDA for use 

in the treatment of OUD either: 

(i) As authorized by 21 U.S.C. 829(e), 

including pursuant to any other form of 

telemedicine as defined in 21 U.S.C. 

802(54) or pursuant to practices as 

determined by regulation issued 

pursuant to 21 U.S.C. 829(e)(3)(B); or 

(ii) After the prescribing practitioner 

has conducted at least one in-person 

medical evaluation of the patient, as 

defined in 21 U.S.C. 829(e)(2)(B). 

(3) PDMP inaccessible or unavailable. 

If the PDMP data is inaccessible or 

unavailable for any reason, the 

prescribing practitioner shall annotate 

in the patient’s EHR or paper record the 

date and time that an attempt to view 

the PDMP data was made and the reason 

the data could not be reviewed. A 

practitioner may prescribe a seven-day 

supply of medication and must perform 

another PDMP review before prescribing 

another seven-day supply. Each time the 

PDMP is reviewed or attempted to be 

reviewed, the date and time must be 

annotated in the patient’s EHR. A sevenday supply prescribed pursuant to this 

paragraph (b)(3) counts toward the time 

limit described in paragraph (b)(2) of 

this section. 

(4) Pharmacy identification 

requirement. The pharmacist shall 

verify the identity of the patient prior to 

filling a controlled medication 

prescription issued under the authority 

of this section. The pharmacist shall 

verify the identity of the patient with a 

state or Federal Government-issued 

photographic identification card or 

other form of identification. For the 

purposes of verifying the identity of the 

patient, the pharmacist may accept 

identification in the manner described 

herein from any qualifying ‘‘ultimate 

user’’ as defined in 21 U.S.C. 802(27) 

prior to filling the prescription. 

(5) Prescription only for treatment of 

OUD. Controlled medication 

prescriptions issued pursuant to this 

section may only be issued for the 

treatment of OUD. 

(6) Authorization to prescribe. The 

practitioner must be: 

(i) Authorized under 21 CFR 

1301.13(e)(1)(iv) to prescribe the basic 

class of controlled medication specified 

on the prescription; or 

(ii) Exempt from obtaining a 

registration to dispense controlled 

substances under 21 U.S.C. 822(d). 

(7) Consistent with general 

prescription requirements. The issuance 

of the controlled substance prescription 

otherwise complies with the 

requirements set forth in 21 CFR part 

1306. 

[FR Doc. 2025–01049 Filed 1–15–25; 8:45 am] 

BILLING CODE 4410–09–P 

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. 

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 


KHAMMOND on DSK9W7S144PROD with RULES6
6524 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

2 88 FR 12875 (Mar. 1, 2023). 

3A ‘‘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. 

4Pursuant to 21 CFR 1300.04(f), the term ‘‘inperson-medical evaluation’’ means a medical 

evaluation that is conducted with the patient in the 

physical presence of the practitioner. 

5Public Law 110–425, 122 Stat. 4820 (2008). 

6The Attorney General has delegated this 

authority to the Administrator of DEA under 28 

CFR 0.100(b). 

7The 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). 

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. 

11 Id. 829(e)(3)(A). 

12This definition of telemedicine does not 

exclude a pharmacist functioning as a mid-level 

practitioner authorized to prescribe controlled 

substances. 

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. 

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

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 inperson 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). 

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

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

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 


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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 6525 

13 21 U.S.C. 802(54). 14Congress 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). 16 42 CFR 410.78(a)(3). 

17William 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. 

18Thomas 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(Final)%20+Esign.pdf. 

19 88 FR 12875 (Mar. 1, 2023). 

20 88 FR 12890 (Mar. 1, 2023). 

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

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 DEAregistered 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 DEAregistered 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

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 inperson 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

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 

• A March 31, 2020 ‘‘Dear Registrant’’ 

letter signed by Thomas W. Prevoznik, 

DEA’s then-Deputy Assistant 

Administrator, Diversion Control 

Division.18

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. 

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 inperson 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 


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6526 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

21Temporary Extension of COVID–19 

Telemedicine Flexibilities for Prescription of 

Controlled Medications, 88 FR 30037 (May 10, 

2023). 22 88 FR 30037 (May 10, 2023). 

referral would involve a physical 

evaluation conducted by another DEAregistered 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 oneyear 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. 

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 


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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 6527 

23Aday, L.A. (2002). At Risk in America: The 

Health and Health Care Needs of Vulnerable 

Populations in the United States, 2 (13). 24Frequently Asked Questions—VA EHR 

Modernization. https://digital.va.gov/ehrmodernization/frequently-asked-question/ 

#:∼:text=VA%27s%20Electronic%20Health

%20Record%20Modernization

%20(EHRM)%20program%20is%20managing

%20the,)%2C%20to%20the%20Federal%20EHR. 

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. 

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 inperson 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 inperson 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. 

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 inperson 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, 


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6528 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

25Moore 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/. 

26The Department of Veterans Affairs, Annual 

Benefits Report 2023 (2023), https://

www.benefits.va.gov/REPORTS/abr/docs/2023- 

abr.pdf. 

27Ernstmeyer K, Christman E. (2022). Nursing: 

Mental Health and Community Concepts, 

Vulnerable Populations. https://

www.ncbi.nlm.nih.gov/books/NBK590046/#. 

28Aday, L.A. (2002). At Risk in America: The 

Health and Health Care Needs of Vulnerable 

Populations in the United States, 2 (13). 

29Waisel, D.B. (2013). Vulnerable populations in 

healthcare, Current Opinion in Anesthesiology 

26(2), 186–192. 

30The 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. 

31The Department of Veterans Affairs, Care of 

Complex Chronic Conditions (2024), https://

www.hsrd.research.va.gov/research/portfolio_

description.cfm?Sulu=9. 

32The 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. 

33Musich, 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/. 

35Ernstmeyer K, Christman E. (2022). Nursing: 

Mental Health and Community Concepts, 

Vulnerable Populations. https://

www.ncbi.nlm.nih.gov/books/NBK590046/#. 

36 Id. 

37The Department of Veterans Affairs, Annual 

Benefits Report 2023 (2023), 103, https://

www.benefits.va.gov/REPORTS/abr/docs/2023- 

abr.pdf. 

38McGuffin, J.J., Riggs, S.A., Raiche, E.M., & 

Romero, D.H. (2021). Military and Veteran helpseeking behaviors: Role of mental health stigma and 

leadership. Military Psychology, 33(5), 332–340. 

https://doi.org/10.1080/08995605.2021.1962181. 

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. 

40About 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. 

41Readiness 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/ 

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. 

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

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. 

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. 

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. 

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


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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/. 

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. 

43Ten Key Principles for Successful Health 

Systems Integration—PMC (nih.gov). https://

www.ncbi.nlm.nih.gov/pmc/articles/PMC3004930/. 

44Frequently Asked Questions—VA EHR 

Modernization. https://digital.va.gov/ehrmodernization/frequently-asked-question/ 

#:∼:text=VA%27s%20Electronic%20Health

%20Record%20Modernization

%20(EHRM)%20program%20is%20managing

%20the,)%2C%20to%20the%20Federal%20EHR. 45 88 FR 12875 (Mar. 1, 2023). 

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. 

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

III. Summary of the General 

Telemedicine NPRM’s Veteran AffairsSpecific 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 inperson 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 veteranrelated 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 


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46 DEA is proposing to address this issue more 

generally for individuals outside of the VA 

healthcare system under the Special Registrations 

NPRM. 

47McGuffin, J. J., Riggs, S.A., Raiche, E.M., & 

Romero, D.H. (2021). Military and Veteran helpseeking behaviors: Role of mental health stigma and 

leadership. Military Psychology, 33(5), 332–340. 

https://doi.org/10.1080/08995605.2021.1962181. 

48 38 CFR 17.417(a)(4) and (b) define a healthcare 

professional’s scope while practicing telemedicine 

within the VA healthcare system. 

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. 

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 inperson 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. 

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 inperson 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. 

V. Scope of Final Rule 

Once an in-person medical evaluation 

of a VA patient has been conducted by 

a VA practitioner, this practitionerpatient 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 


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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 6531 

49This 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 noncontrolled 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. 

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. 

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. 

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

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 InPerson 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 inperson 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 nonoperational, 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 


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6532 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

51Office of Management and Budget (OMB) 

Circular A–4. 

52Accordingly, in discussing such studies, DEA 

will use the word the word ‘‘telehealth’’ instead of 

telemedicine. 

53Patel 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. 54Rhyan 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). 55Fair 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). 

56Bureau 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. 

57Bureau of Labor Statistics, Employer Costs for 

Employee Compensation—June 2024, https://

www.bls.gov/news.release/archives/ecec_

09102024.pdf (accessed 11/13/2024). 

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. 

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) × 

(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

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

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. 

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 × $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). 


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58Akinlotan, 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/irsdrop/n-24-08.pdf (accessed 10/18/2024). 

60U.S. Department of Veterans Affairs, 

Reimbursed VA travel expenses and mileage rate, 

https://www.va.gov/resources/reimbursed-va-travelexpenses-and-mileage-rate/ (accessed 11/12/2024). 

Therefore, the $33.58 loaded hourly 

wage represents the hourly average 

opportunity cost to travel and wait for 

a practitioner’s appointment. 

TABLE 1—PATIENTS LOADED HOURLY WAGE

Occupation Hourly wage 

($) 

Load for 

benefits 

($) 

Loaded 

hourly 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 × $33.58), as can be seen in table 

2 below. 

TABLE 2—PATIENT COST OF TIME

[per Practitioner’s Appointment] 

Cost savings 

Hourly 

opportunity 

cost 

($) 

Travel and 

wait time 

(hours) 

Cost per 

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 × 19.8), as can be seen in table 

3 below. 

TABLE 3—PATIENT TRAVEL COST PER TRIP

Cost savings 

Travel cost 

per mile 

($) 

Travel 

distance 

(miles) 

Per 

appointment 

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 × 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. 

TABLE 4—VA REIMBURSEMENT AND PATIENT NET TRAVEL COST PER TRIP

Travel cost 

per mile 

($) 

Travel 

distance 

(miles) 

Per 

appointment 

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 


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6534 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

61Total Patient Cost Savings = (number of firsttime telemedicine visits resulting in prescriptions 

for controlled substances) * (patient cost savings). 

62 VHA. VHA 2023 Annual Report. https://

department.va.gov/vha-annual-report/ (accessed 

10/12/2024). 

63Andino, 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%). 

64U.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. 

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. 

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. 

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. 

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 firsttime, telemedicine visits resulting in 

approximately a total of 676,800 firsttime 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 prescriptions 

Number of 

visits 

(thousands) 

Total number of 

prescriptions 

(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 


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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-surescriptsillegal-monopolization-case (accessed 9/24/2024). 

66According 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). 

67 Gerhart J, Piff A, Bartelt K, Barkley E. Most 

Primary Care Telehealth Visits Unlikely to Need InPerson Follow-Up. Epic Research. https://

www.epicresearch.org/articles/most-primary-caretelehealth-visits-unlikely-to-need-in-person-followup (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-unlikelyto-require-in-person-follow-up-within-90-days 

(accessed 10/20/2024). 

TABLE 6—ESTIMATE OF NUMBER OF PRESCRIPTIONS USING VISIT DATA—Continued 

Number of prescriptions 

Number of 

visits 

(thousands) 

Total number of 

prescriptions 

(thousands) 

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 prescriptions .................................................................................................. .......................... 676,800 

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 firsttime telemedicine visits resulting in 

prescriptions for controlled substances, 

as can be seen in table 8. 

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 firsttime 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 inperson 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. 


KHAMMOND on DSK9W7S144PROD with RULES6
6536 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

69Bureau 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. 

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.) 

71Bureau of Labor Statistics, Employer Costs for 

Employee Compensation—March 2023, https://

www.bls.gov/news.release/archives/ecec_

06162023.pdf (accessed 9/24/2024). 

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-person follow up visit. ............. .................... .......................... .................... 0.61 

First-time telemedicine visits under this rule with CS prescriptions .......................... .................... .......................... .................... 66,056 

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 firsttime telemedicine visits under the 

proposed rule with controlled substance 

prescriptions results in a total patient 

cost savings of $2,540,514 ($38.46 × 

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 × 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

Total cost 

savings 

($) 

VA 

reimbursement 

($) 

Patient net 

cost 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

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 

× 1.453), $90.83 ($62.51 × 1.453), and 

$88.20 ($60.70 × 1.453), for physicians, 

PAs, and NPs, respectively. 

Based on a 2018 study, it takes a 

practitioner 27 seconds to log in and 37 

seconds to retrieve a report once logged 


KHAMMOND on DSK9W7S144PROD with RULES6
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 6537 

72Bachhuber 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. 73 DEA estimate based on registrations. 74Snoswell CL, Taylor ML, et al. Determining if 

Telehealth Can Reduce Health System Costs: 

Scoping Review. J Med Internet Res. October 2020. 

75 Id. 

76Amin K, Rae M, et al. Early in the pandemic, 

private insurer payments for telehealth and inperson claims were similar. Peterson-KFF Health 

System Tracker. January 18, 2023. https://

www.healthsystemtracker.org/brief/telehealthpayments-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). 

77See, 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-clinicalpresident-digital-health-company-arrested-100madderall-distribution. 

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 × 0.017), 

for physician assistants is $1.54 ($90.83 

× 0.017), and for nurse practitioners is 

$1.50 ($88.20 × 0.017). Table 11 

summarizes the results. 

TABLE 11—EHR AND PDMP CHECK TIME COST

Occupation Hourly wage 

($) 

Load for 

benefits 

($) 

Loaded 

hourly wage 

($) 

PDMP 

check time 

(hours) 

Cost per 

PDMP 

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. 

TABLE 12—EHR PDMP CHECK TIME COST

Occupation VA 

registrants 

VA 

registrant 

weights 

Cost per 

PDMP 

check 

($) 

Weighted cost 

per PDMP 

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 × 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

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

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. 

Admittedly, there is little quantified 

data on diversion since the onset of the 

COVID–19 pandemic. However, Dea is 


KHAMMOND on DSK9W7S144PROD with RULES6
6538 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

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. 

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. 

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 


KHAMMOND on DSK9W7S144PROD with RULES6
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 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 

■ 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. 

■ 2. Add § 1306.52 to read as follows: 

§ 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 

§ 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)) (§ 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 inperson 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 nonoperational, 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 followup 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 

■ 3. The authority citation for part 12 

continues to read as follows: 

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

■ 4. Add § 12.4 to read as follows: 

§ 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 inperson medical evaluation by any VA 

practitioner who at the time of the inperson 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 


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6540 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Rules and Regulations 

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 nonoperational, 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 


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