Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6541 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Parts 1300, 1301, 1304, and 

1306 

[Docket No. DEA–407] 

RIN 1117–AB40 

Special Registrations for Telemedicine 

and Limited State Telemedicine 

Registrations 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Ryan Haight Online 

Pharmacy Consumer Protection Act of 

2008 (the ‘‘Ryan Haight Act’’) generally 

requires an in-person medical 

evaluation prior to the issuance of a 

prescription of controlled substances 

but provides an exception to this inperson medical evaluation requirement 

where the practitioner is engaged in the 

‘‘practice of telemedicine’’ within the 

meaning of the Ryan Haight Act. These 

proposed regulatory changes would 

establish a Special Registration 

framework and authorize three types of 

Special Registration. This proposed 

rulemaking also provides for heightened 

prescription, recordkeeping, and 

reporting requirements. DEA believes 

such changes are necessary to 

effectively expand patient access to 

controlled substance medications via 

telemedicine while mitigating the risks 

of diversion associated with such 

expansion. A summary of this rule may 

be found at https://

www.regulations.gov/docket/DEA-2023- 

0029. 

DATES: Electronic comments must be 

submitted, and written comments must 

be postmarked, on or before March 18, 

2025. Commenters should be aware that 

the electronic Federal Docket 

Management System will not accept 

comments after 11:59 p.m. Eastern Time 

on the last day of the comment period. 

All comments concerning collections of 

information under the Paperwork 

Reduction Act must be submitted to the 

Office of Management and Budget 

(OMB) on or before March 18, 2025. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–407’’ on all correspondence, 

including any attachments. 

• Electronic comments: DEA 

encourages that all comments be 

submitted electronically through the 

Federal eRulemaking Portal, which 

provides the ability to type comments 

directly into the comment field on the 

web page or to attach a file containing 

comments. Please go to http://

www.regulations.gov and follow the 

online instructions at that site for 

submitting comments. Upon completion 

of your submission, you will receive a 

Comment Tracking Number for your 

comment generated by http://

www.regulations.gov. Please be aware 

that submitted comments are not 

instantaneously available for public 

view on http://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted, and there is no 

need to resubmit the same comment. 

• Paper comments: Paper comments 

that duplicate the electronic submission 

are discouraged. Should you wish to 

mail a paper comment in lieu of 

submitting a comment electronically, it 

should be sent via regular or express 

mail to: Drug Enforcement 

Administration, Attn: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. Hand-delivered comments will 

not be accepted. 

• Paperwork Reduction Act 

Comments: All comments concerning 

collections of information under the 

Paperwork Reduction Act must be 

submitted to the Office of Information 

and Regulatory Affairs, OMB, Attention: 

Desk Officer for DOJ, Washington, DC 

20503. Please state that your comment 

refers to RIN 1117–AB40/Docket No. 

DEA–407. 

FOR FURTHER INFORMATION CONTACT: 

Heather E. Achbach, Regulatory Drafting 

and Policy Support Section, Diversion 

Control Division, Drug Enforcement 

Administration; Telephone: (571) 776– 

3882. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received, including attachments and 

other supporting materials, in response 

to this docket are considered part of the 

public record. The Drug Enforcement 

Administration (DEA) will make all 

comments available for public 

inspection online at http://

www.regulations.gov. The Freedom of 

Information Act applies to all comments 

received. Confidential information or 

personal identifying information (PII), 

such as account numbers or Social 

Security numbers, or names of other 

individuals, should not be included. 

Submissions will not be edited to 

remove any identifying or contact 

information. 

Comments with confidential 

information, which should not be made 

available for public inspection, should 

be submitted as written/paper 

submissions. Two written/paper copies 

should be submitted. One copy will 

include the confidential information 

with a heading or cover sheet that states 

‘‘CONTAINS CONFIDENTIAL 

INFORMATION.’’ DEA will review this 

copy, including the claimed 

confidential information, in its 

consideration of comments. The second 

copy should have the claimed 

confidential information redacted/ 

blacked out. DEA will make this copy 

available for public inspection online at 

http://www.regulations.gov. Other 

information, such as name and contact 

information, that should not be made 

available, may be included on the cover 

sheet but not in the body of the 

comment, and must be clearly identified 

as ‘‘confidential.’’ Any information 

clearly identified as ‘‘confidential’’ will 

not be disclosed except as required by 

law. 

Overview 

I. Executive Summary 

II. Legal Authority and Background 

III. Need for Further Rulemaking: Special 

Registration 

IV. Section-by-Section Discussion of 

Proposed Rule 

A. Registration Requirements Under 21 

CFR Part 1301 

1. Three Types of Special Registration and 

Eligibility of Clinician Practitioners and 

Platform Practitioners 

a. Telemedicine Prescribing Registration 

Eligibility 

b. Advanced Telemedicine Prescribing 

Registration Eligibility 

c. Telemedicine Platform Registration 

Eligibility 

2. Ancillary Registrations: State 

Telemedicine Registrations 

3. Special Registration Application Process 

a. Special Registration Application, Cycles, 

and Fees 

b. Supplemental Special Registration 

Application Requirements (Form 224S) 

c. Notification of Changes to Application 

Information and Other Modifications 

(Form 224S–M) 

4. Special Registration Actions 

a. Approvals and Denials of Special 

Registration Applications 

b. Suspension and Revocations of Special 

Registrations 

B. Special Registration Prescriptions Issued 

by Clinician Special Registrants under 

21 CFR part 1306 

1. Manner of Issuance of Special 

Registration Prescriptions 

2. Additional Elements on a Special 

Registration Prescription 

C. Recordkeeping and Reporting Under 21 

CFR Part 1304 

1. Patient Verification Photographic 

Records 

2. Special Registration Telemedicine 

Encounter Records 

3. Credentials Verification and ConductRelated Documentation Records 

4. Centralized Recordkeeping at the Special 

Registered Location 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
6542 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

1 Italicized terms indicate that it is a proposed 

term defined by the NPRM or a term currently 

defined in the CSA or DEA’s regulations. 

2 21 U.S.C. 829(e)(1). 

3 21 U.S.C. 829(e)(2)(B)(i). 

4 21 U.S.C. 829(e)(2)(A)(i). 

5 21 U.S.C. 829(e)(3)(A). 

6 21 U.S.C. 802(54). 

7The term ‘‘institutional practitioner’’ is 

currently defined at 21 CFR 1300.01. Proposed 

changes to 21 CFR 1300.01 will explicitly exclude 

5. Pharmacy and Special Registrant 

Reporting of Special Registration 

Prescription Data 

6. Individual Special Registrant Reporting 

of Aggregated Special Registration 

Prescription Data 

D. Regulatory Definitions Under 21 CFR 

Part 1300 

E. Request for Comments 

V. Regulatory Analyses 

I. Executive Summary 

The Ryan Haight Online Pharmacy 

Consumer Protection Act of 2008 (the 

‘‘Ryan Haight Act’’), amended the 

Controlled Substances Act (CSA) by, 

among other things, requiring all 

prescription drugs which are dispensed 

by means of the internet 1 be issued as 

a ‘‘valid prescription.’’ 2 Generally, a 

valid prescription requires, at a 

minimum, at least one ‘‘in-person 

medical evaluation,’’ 3 which is issued 

for a legitimate medical purpose in the 

usual course of professional practice.4

The Ryan Haight Act does, however, 

provide an exception to this in-person 

medical evaluation requirement, when 

the practitioner is ‘‘engaged in the 

practice of telemedicine.’’ 5

The Ryan Haight Act provides seven 

(7) distinct categories of the practice of 

telemedicine in which a prescribing 

practitioner need not satisfy the Ryan 

Haight Act’s in-person medical 

evaluation requirement, yet nonetheless 

may be able to prescribe a controlled 

substance for a legitimate medical 

purpose in the usual course of 

professional practice.6 In these 

circumstances, provided certain 

safeguards are in place to ensure that 

the practitioner who is engaged in the 

practice of telemedicine is able to 

conduct a bona fide medical evaluation 

of the patient at the remote location, and 

is otherwise acting in the usual course 

of professional practice, the Ryan 

Haight Act contemplates that the 

practitioner will be permitted to 

prescribe controlled substances by 

means of the internet despite not having 

conducted an in-person medical 

evaluation. 

Thus far, DEA has permitted, or 

promulgated regulations to permit, the 

practice of telemedicine pursuant to two 

of the seven categories of telemedicine 

authorized under the Ryan Haight Act. 

In March 2020, in response to the 

COVID–19 Public Health Emergency 

(‘‘COVID–19 PHE’’) declared by the 

Secretary (the ‘‘Secretary’’) of the 

Department of Health and Human 

Services (HHS) on January 31, 2020, 

pursuant to the authority under section 

319 of the Public Health Service Act (42 

U.S.C. 247), DEA used its authority 

under 21 U.S.C. 802(54)(D) to grant 

temporary exceptions to the Ryan 

Haight Act and its implementing 

regulations, allowing authorized 

practitioners to generally prescribe 

controlled substances in Schedules II–V 

through telemedicine. 

Three years later, in March 2023, 

DEA, in concert with HHS, promulgated 

two notices of proposed rulemakings 

(NPRMs) (the ‘‘General Telemedicine 

NPRM,’’ and ‘‘Buprenorphine NPRM’’) 

pursuant to 21 U.S.C. 802(54)(G), which 

collectively proposed to expand patient 

access to prescriptions via telemedicine 

relative to the pre-COVID–19 PHE 

landscape. On May 10, 2023, to prevent 

a lapse of care with the expiration of the 

COVID–19 PHE, DEA, jointly with HHS, 

promulgated a rule (the ‘‘First 

Temporary Rule’’) pursuant to 21 

U.S.C.802(54)(G) to extend the 

temporary exceptions originally 

authorized under the COVID–19 PHE 

through November 11, 2023. 

On September 12 and 13, 2023, DEA 

hosted live, in-person Telemedicine 

Listening Sessions to receive additional 

input concerning the practice of 

telemedicine with regards to controlled 

substances and potential safeguards that 

could effectively prevent and detect 

diversion of controlled substances 

prescribed via telemedicine. DEA 

invited the public to express their views 

concerning the advisability of 

permitting telemedicine prescribing of 

certain controlled substances without 

any in-person medical evaluation at all, 

the availability and types of data that 

would be useful in detecting diversion 

of controlled substances via 

telemedicine, and specific additional 

safeguards that could be placed around 

the prescribing of Schedule II controlled 

substances via telemedicine. 

On October 10, 2023, in light of the 

need to further evaluate the best course 

of action given the comments received 

in response to the March 2023 NPRMs 

and the presentations at the September 

2023 Telemedicine Listening Sessions, 

DEA, jointly with HHS, issued a second 

temporary rule (the ‘‘Second Temporary 

Rule’’) to further extend the temporary 

exceptions originally authorized under 

the COVID–19 PHE through December 

31, 2024. On November 19, 2024, DEA 

and HHS issued a third temporary rule 

(the ‘‘Third Temporary Rule’’) to again 

extend the temporary exceptions 

originally authorized under the COVID– 

19 PHE through December 31, 2025, to 

ensure a smooth transition for patients 

and practitioners that have come to rely 

on the availability of telemedicine for 

controlled substance prescriptions. 

The Third Temporary Rule has also 

provided additional time for DEA to 

promulgate the Special Registration 

regulations proposed in this NPRM, and 

additional time for practitioners to come 

into compliance with any new 

standards or safeguards eventually 

found within a final rule establishing a 

Special Registration framework. DEA 

has determined that the best course of 

action to ensure patient access to care, 

while maintaining sufficient safeguards 

to prevent and detect diversion of 

controlled substances, is to establish 

and maintain a regulatory scheme 

including three separate Special 

Registrations pursuant to 21 U.S.C. 

802(54)(E) and 21 U.S.C. 831(h). 

These separate Special Registrations 

would allow more comprehensive 

prescribing, including prescribing of 

Schedule II and narcotic and nonnarcotic controlled substances in 

limited circumstances, by properly 

registered physicians and mid-level 

practitioners (hereinafter collectively 

referred to as clinician practitioners), 

and dispensing by online telemedicine 

platforms that constitute covered online 

telemedicine platforms, in their capacity 

as platform practitioners, who have 

proven to have a legitimate need for 

such Special Registrations and where 

DEA has concluded that such 

registration is consistent with the public 

interest. Once properly registered under 

the Special Registration framework, 

clinician practitioners would be 

considered clinician special registrants 

and covered online telemedicine 

platforms, in their capacity as platform 

practitioners, would be considered 

platform special registrants. 

This NPRM introduces the three types 

of Special Registrations for 

Telemedicine: (1) a Telemedicine 

Prescribing Registration, authorizing 

qualified clinician practitioners to 

prescribe Schedule III–V controlled 

substances via telemedicine, (2) an 

Advanced Telemedicine Prescribing 

Registration, authorizing qualified, 

specialized clinician practitioners (e.g., 

psychiatrists, hospice care physicians) 

to prescribe Schedule II–V controlled 

substances via telemedicine, and (3) a 

Telemedicine Platform Registration, 

authorizing covered online telemedicine 

platforms, in their capacity as platform 

practitioners, to dispense Schedule II–V 

controlled substances.7 To satisfy the 


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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6543 

‘‘covered online telemedicine platform’’ to clarify 

that such an entity is not an ‘‘institutional 

practitioner.’’ 8 21 U.S.C. 802(54)(E). 

9See Appendix A for Chart: Do I Need a Special 

Registration for Telemedicine? 

10 ‘‘Dispense’’ in the context of this rulemaking 

means to deliver a controlled substance to an 

ultimate user, which includes the prescribing of a 

controlled substance. 21 U.S.C 802(10). 

11 21 U.S.C. 871(b), 958(f). 

statutory requirements under 21 U.S.C. 

831(h), DEA would also require the 

special registrant to maintain a State 

Telemedicine Registration for every 

state in which a patient is treated by the 

special registrant, unless otherwise 

exempted. The State Telemedicine 

Registration would be issued by DEA, 

not the states, and operate as an 

ancillary credential, contingent on the 

Special Registration held by the special 

registrant. 

To streamline the Special Registration 

application process, the NPRM would 

introduce a new registration application 

form, known as Form 224S. The three 

types of Special Registrations 

(Telemedicine Prescribing Registration, 

Advanced Telemedicine Prescribing 

Registration, and Telemedicine Platform 

Registration) and the State Telemedicine 

Registration (one type for clinician 

special registrants and one type for 

platform special registrants) would be 

on a three-year cycle. The NPRM also 

proposes heightened prescription 

requirements addressing the manner in 

which special registration prescriptions 

are issued, as well as additional 

elements required to be on a special 

registration prescription issued under a 

Special Registration. 

Special registration prescriptions 

issued under the Special Registration 

would be required to be prescribed 

through electronic prescribing for 

controlled substances (EPCS), and after 

the special registrant has verified the 

identity of the patient and carried out a 

nationwide Prescription Drug 

Monitoring Program (PDMP) check of all 

50 states and any U.S. district or 

territory that maintains its own PDMP 

(referred to as the ‘‘nationwide PDMP 

check’’). The nationwide PDMP check 

requirement, however, would have a 

delayed effective date of three years. In 

the interim, for all Schedule II–V 

controlled substances, clinician special 

registrants would be required to 

conduct a PDMP check of: (1) the state/ 

territory where the patient is located; (2) 

the state/territory where the clinician 

special registrant is located; and (3) any 

state/territory that has a PDMP 

reciprocity agreement with the states/ 

territories where the patient and 

clinician special registrant are located. 

Furthermore, special registration 

prescriptions would require the 

inclusion of the Special Registration 

numbers of the clinician special 

registrant and the platform special 

registrant (if a platform special 

registrant facilitated the prescription), 

and the State Telemedicine Registration 

numbers of the clinician special 

registrant and platform special 

registrant (if a platform special 

registrant facilitated the prescription). 

To ensure clarity and easy identification 

of the type of registration, Special 

Registration numbers and State 

Telemedicine Registration numbers 

would be formatted distinctly. This 

would allow registrants and DEA to 

differentiate them from each other and 

from conventional DEA registration 

numbers issued under 21 U.S.C. 823(g). 

Additionally, pharmacies filling special 

registration prescriptions would be able 

to easily verify these registration 

numbers to confirm that the prescribing 

clinician practitioner is authorized to 

prescribe controlled substances within a 

given Schedule via a Special 

Registration, and that a platform 

practitioner, if one facilitated the 

special registration prescription, is 

authorized to dispense controlled 

substances under the Special 

Registration framework. 

It is also important to note when the 

proposed regulations would not apply. 

The Ryan Haight Act, and the 

telemedicine regulations implementing 

it thereunder, apply only in limited 

circumstances, impacting only a subset 

of practitioner-patient relationships: 

those where the prescribing practitioner 

intends to prescribe controlled 

substances, and has never conducted an 

in-person medical evaluation of the 

patient prior to the issuance of the 

prescription. In other words, the 

regulations implemented under the 

Ryan Haight Act would not be 

applicable to practitioner-patient 

relationships in which there has ever 

been a prior in-person medical 

evaluation of the patient by the 

practitioner. 

Moreover, the regulations proposed in 

this rule are further limited to 

telemedicine practiced under a Special 

Registration,8 but would not apply to 

the other forms of the practice of 

telemedicine authorized under the Ryan 

Haight Act. The proposed regulations 

within this NPRM would not apply to 

the practice of telemedicine authorized 

under 21 U.S.C. 802(54)(A)–(D), (F), and 

(G). Therefore, these proposed 

regulations would not apply to the 

practice of telemedicine authorized 

under the Expansion of Buprenorphine 

Treatment via Telemedicine Encounter 

final rule (RIN 1117–AB78) or the 

Continuity of Care via Telemedicine for 

Veterans Affairs Patients final rule (RIN 

1117–AB88) published elsewhere in this 

issue of the Federal Register. Under the 

authority of 21 U.S.C. 802(54)(G), these 

final rules permit, in limited 

circumstances, certain prescribing 

practitioners to issue prescriptions for 

controlled substances by telemedicine, 

without having personally performed an 

in-person medical evaluation or 

fulfilling the Special Registration 

requirements as proposed within this 

rule. At this stage, DEA remains 

committed to actively soliciting and 

considering feedback from the public 

and revising the Special Registration 

regulations as necessary and 

appropriate.9

II. Legal Authority and Background 

DEA implements and enforces the 

CSA and the Controlled Substances 

Import and Export Act, (21 U.S.C. 801– 

971), as amended. DEA publishes the 

implementing regulations for these 

statutes in 21 CFR parts 1300 to end. 

These regulations are designed to ensure 

a sufficient supply of controlled 

substances for medical, scientific, and 

other legitimate purposes, and to deter 

the diversion of controlled substances 

for illicit purposes. As mandated by the 

CSA, DEA establishes and maintains a 

closed system of control for 

manufacturing, distribution, and 

dispensing of controlled substances, and 

requires any person who manufactures, 

distributes, dispenses, imports, exports, 

or conducts research or chemical 

analysis with controlled substances to 

register with DEA, unless they meet an 

exemption, pursuant to 21 U.S.C. 822.10

The CSA further authorizes the Attorney 

General (and the Administrator by 

delegation through 28 CFR part 0) to 

promulgate regulations necessary and 

appropriate to execute the functions of 

subchapter I (Control and Enforcement) 

and subchapter II (Import and Export) of 

the CSA.11

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 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
6544 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

12 21 U.S.C. 829(e)(1). 

13 Id. at 829(e)(2)(A)(i). Under the Ryan Haight 

Act, the requirement of an in-person medical 

evaluation does not apply to a ‘‘covering 

practitioner,’’ id. 829(e)(2)(A)(ii), as defined by 

829(e)(2)(C). A prescribing practitioner meeting this 

definition need not conduct an in-person medical 

evaluation as a prerequisite to prescribing a 

controlled substance to a given patient, provided 

that the practitioner for whom the practitioner is 

covering has provided an in-person medical 

evaluation of that patient and provided further that 

this covering arrangement is taking place on only 

a temporary basis. In addition, the covering 

practitioner—as with all practitioners who 

prescribe controlled substances—remains subject to 

the requirement that such prescriptions may be 

issued only for a legitimate medical purpose in the 

usual course of professional practice. Id. 

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

15While this statutory definition of the practice 

of telemedicine explicitly excludes pharmacists, 

such exclusion does not apply to situations where 

a pharmacist is acting in their capacity as a midlevel practitioner, authorized to dispense controlled 

substances in accordance with their state licensure. 

16 42 U.S.C. 1395m(m) references, but does not 

define, such telecommunications systems. The 

Center for Medicare and Medicaid Services (CMS) 

promulgated regulations implementing these 

statutory provisions and define the term interactive 

telecommunications system. 42 CFR 410.78(a)(3) 

defines interactive telecommunications system as 

‘‘. . . [the] multimedia communications equipment 

that includes, at a minimum, audio and video 

equipment permitting two-way, real-time 

interactive communication between the patient and 

distant site physician or practitioner. For services 

furnished for purposes of diagnosis, evaluation, or 

treatment of a mental health disorder to a patient 

in their home, interactive telecommunications may 

include two-way, real-time audio-only 

communication technology if the distant site 

physician or practitioner is technically capable to 

use an interactive telecommunications system as 

defined in the previous sentence, but the patient is 

not capable of, or does not consent to, the use of 

video technology’’ (emphases added). Though 

DEA’s proposed regulatory definition for audiovideo telecommunications system largely aligns 

with CMS’s definition of interactive 

telecommunications system, DEA’s proposed 

regulations would not authorize the use of audioonly communication technology for the diagnosis, 

evaluation, or treatment of mental health disorders, 

subject to one exception for opioid use disorder 

discussed in more depth later. These provisions 

reflect the heightened risks associated with 

prescribing controlled substances specifically. 

17Congress enacted legislation in addition to the 

Ryan Haight Act which required DEA to 

‘‘promulgate final regulations specifying . . . the 

limited circumstances in which a special 

registration for telemedicine may be issued.’’ 21 

U.S.C. 831(h)(2). In particular, the SUPPORT for 

Patients and Communities Act (‘‘SUPPORT Act’’), 

signed into law on October 24, 2018, mandated that, 

in consultation with the Secretary [of Health and 

Human Services], the Attorney General shall 

promulgate final regulations specifying—(A) the 

limited circumstances in which a special 

registration for telemedicine . . . may be issued; 

and (B) the procedure for obtaining [a] special 

registration for telemedicine.’’ Substance UseDisorder Prevention that Promotes Opioid Recovery 

and Treatment for Patients and Communities Act 

(SUPPORT Act), Public Law 115–271, 3232, 132 

Stat. 3894, 3950 (2018). The Attorney General has 

delegated this authority to the Administrator of 

DEA. See 28 CFR 0.100. As required by the 

SUPPORT Act, DEA has consulted with 

representatives of the Secretary of Health and 

Human Services regarding the substance of this 

proposed rule. 

18 21 U.S.C. 802(54). 

Cosmetic Act may be . . . dispensed by 

means of the internet without a valid 

prescription,’’ 12 and which defines 

‘‘valid prescription’’ as ‘‘a prescription 

that is issued for a legitimate medical 

purpose in the usual course of 

professional practice by . . . a 

practitioner who has conducted at least 

1 in-person medical evaluation of the 

patient.’’ 13 Section 829(e), however, 

provides an exception to this in-person 

medical evaluation requirement where 

the practitioner is ‘‘engaged in the 

practice of telemedicine.’’ 14

Pursuant to 21 U.S.C. 802(54) the 

practice of telemedicine means ‘‘the 

practice of medicine in accordance with 

applicable Federal and state laws by a 

practitioner (other than a pharmacist) 15

who is at a location remote from the 

patient and is communicating with the 

patient, or health care professional who 

is treating the patient, using a 

telecommunications system 16 referred 

to in section 1395m(m) of Title 42,’’ and 

which also falls within one of seven 

distinct categories that Congress 

determined were appropriate to allow 

for the prescribing of controlled 

substances via telemedicine despite the 

practitioner never having conducted an 

in-person medical evaluation of the 

patient. 

The seven distinct categories 

provided under the statutory definition 

of the practice of telemedicine generally 

involve either circumstances in which 

an in-person medical evaluation has 

been rendered impracticable due to 

temporary emergencies, or 

circumstances in which the prescribing 

practitioner might be unable to satisfy 

the Ryan Haight Act’s in-person medical 

evaluation requirement, yet nonetheless 

has sufficient medical information to 

prescribe a controlled substance for a 

legitimate medical purpose in the usual 

course of professional practice. In these 

circumstances, provided certain 

safeguards are in place to ensure that 

the practitioner who is engaged in the 

practice of telemedicine is able to 

conduct a bona fide medical evaluation 

of the patient at the remote location, and 

is otherwise acting in the usual course 

of professional practice, the Ryan 

Haight Act contemplates that the 

practitioner will be permitted to 

prescribe controlled substances by 

means of the internet despite not having 

conducted an in-person medical 

evaluation. The Ryan Haight Act defines 

these categories through the definition 

of ‘‘practice of telemedicine,’’ which is 

set forth in 21 U.S.C. 802(54). 

As a general matter, those seven 

distinct categories include telemedicine 

encounters where: (1) a patient is 

physically located at a DEA-registered 

hospital or clinics, and the remote 

prescribing practitioner is DEAregistered in the state in which the 

patient is located; (2) a patient is being 

treated by a prescribing practitioner, 

and in the physical presence of a DEAregistered practitioner in the state in 

which the patient is located; (3) the 

prescribing practitioner is an employee 

or contractor of the Indian Health 

Service (IHS), acting within the scope of 

the practitioner’s employment, who has 

been designated an internet Eligible 

Controlled Substances Provider by HHS; 

(4) it takes place during a public health 

emergency declared by HHS under 

section 247d of title 42; (5) the 

practitioner has obtained a Special 

Registration with DEA; 17 (6) there is a 

medical emergency that prevents the 

patient from being in the physical 

presence of an employee or contractor of 

the Veterans Health Administration 

(VHA) and one of its hospitals or 

clinics, and immediate intervention by 

the practitioner using controlled 

substances is required to prevent injury 

or death; and (7) any other 

circumstances that DEA and HHS have 

jointly determined to be consistent with 

effective controls against diversion and 

otherwise consistent with the public 

health and safety.18

As noted above, the Ryan Haight Act, 

and the telemedicine regulations 

implementing it thereunder, apply only 

in limited circumstances, impacting 

only a subset of practitioner-patient 

relationships: where the prescribing 

practitioner wishes to prescribe 

controlled substances and has never 

conducted an in-person medical 

evaluation of the patient prior to the 

issuance of the prescription. In other 

words, the regulations proposed in this 

rule would not be applicable to 

practitioner-patient relationships in 

which there has been a prior in-person 

medical evaluation of the patient by the 

practitioner. 

COVID–19 Public Health Emergency. 

In response to the COVID–19 PHE, as 

declared by the Secretary on January 31, 

2020, pursuant to the authority under 

section 319 of the Public Health Service 

Act (42 U.S.C. 247), DEA granted 

temporary exceptions to the Ryan 

Haight Act and DEA’s implementing 

regulations under 21 U.S.C. 802(54)(D), 

one of the seven distinct categories of 

telemedicine envisioned under the 

statutory definition of the practice of 

telemedicine. In order to prevent lapses 

in care, these exceptions allowed for the 

prescribing of controlled substances via 


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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6545 

19William 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. 

20Thomas 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. 

21 88 FR 12875 (Mar. 1, 2023). 

22 88 FR 12890 (Mar. 1, 2023). 

23Temporary Extension of COVID–19 

Telemedicine Flexibilities for Prescription of 

Controlled Medications, 88 FR 30037 (May 10, 

2023). 

24Second Temporary Extension of COVID–19 

Telemedicine Flexibilities for Prescription of 

Controlled Medications, 88 FR 69879 (October 10, 

2023). 

telemedicine encounters even when the 

prescribing practitioner had not 

conducted an in-person medical 

evaluation of the patient. These 

telemedicine flexibilities authorized 

practitioners to prescribe Schedule II–V 

controlled substances via audio-video 

telemedicine encounters, including 

Schedule III–V opioid controlled 

substances approved by the Food and 

Drug Administration (FDA) for 

maintenance and withdrawal 

management treatment of opioid use 

disorder via audio-only telemedicine 

encounters, provided that such 

prescriptions otherwise comply with the 

recommendations outlined in DEA 

guidance documents, the requirements 

outlined in DEA regulations, and 

applicable Federal and State law. DEA 

granted those temporary exceptions to 

the Ryan Haight Act and DEA’s 

implementing regulations via two letters 

published in March 2020: 

• A March 25, 2020 ‘‘Dear Registrant’’ 

letter signed by William T. McDermott, 

DEA’s then-Assistant Administrator, 

Diversion Control Division (the 

McDermott Letter); 19 and 

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

letter signed by Thomas W. Prevoznik, 

DEA’s then-Deputy Assistant 

Administrator, Diversion Control 

Division (the Prevoznik Letter).20

Prior NPRMs and Temporary Rules; 

Telemedicine Listening Sessions. On 

March 1, 2023, DEA, in concert with 

HHS and pursuant to 21 U.S.C. 

802(54)(G), promulgated two NPRMs in 

the Federal Register, Telemedicine 

Prescribing of Controlled Substances 

When the Practitioner and the Patient 

Have Not Had a Prior In-Person Medical 

Evaluation (the ‘‘General Telemedicine 

NPRM’’) 21 and Expansion of Induction 

of Buprenorphine via Telemedicine 

Encounter (the ‘‘Buprenorphine 

NPRM’’),22 which proposed to expand 

patient access to prescriptions for 

controlled substances via telemedicine 

encounters relative to the pre-COVID–19 

PHE landscape. The purpose of the two 

proposed rules was to make permanent 

some of the telemedicine flexibilities 

established during the COVID–19 PHE 

in order to facilitate patient access to 

controlled substance medications via 

telemedicine when consistent with 

public health and safety, while 

maintaining effective controls against 

diversion. The comment period for 

these two NPRMs closed on March 31, 

2023. Those NPRMs generated a total of 

38,369 public comments—35,454 

comments on the General Telemedicine 

NPRM and 2,915 comments on the 

Buprenorphine NPRM. 

On May 10, 2023 DEA, jointly with 

HHS (with the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) acting on behalf of HHS), 

issued the First Temporary Rule 

pursuant to 21 U.S.C. 802(54)(G), which 

extended the full set of telemedicine 

flexibilities regarding the prescribing of 

controlled substances, as had been in 

place under the COVID–19 PHE, 

through November 11, 2023.23 The First 

Temporary Rule also provided a 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 the live, in-person Telemedicine 

Listening Sessions, to receive additional 

input concerning the practice of 

telemedicine with regards to prescribing 

controlled substances and potential 

safeguards that could effectively prevent 

and detect diversion of controlled 

substances prescribed via telemedicine. 

DEA invited the public to express their 

views concerning the advisability of 

permitting telemedicine prescribing of 

certain controlled substances without 

any in-person medical evaluation at all, 

the availability and types of data that 

would be useful in detecting diversion 

of controlled substances via 

telemedicine that are either already 

reported or could be reported, and 

specific additional safeguards that could 

be placed around the prescribing of 

Schedule II controlled substances via 

telemedicine. Approximately 58 

stakeholders, including institutional 

practitioners and clinician practitioners, 

pharmacists, trade associations, state 

agencies, and other public interest 

groups, presented at the listening 

sessions. 

On October 10, 2023, in light of the 

need to further evaluate the best course 

of action given the comments received 

in response to the March 2023 NPRMs 

and the presentations at the 

Telemedicine Listening Sessions, DEA, 

jointly with HHS, issued the Second 

Temporary Rule, also pursuant to 21 

U.S.C. 802(54)(G), thereby extending the 

full set of telemedicine flexibilities 

regarding prescription of controlled 

substances as were in place during the 

COVID–19 PHE through December 31, 

2024.24 The extension authorized all 

DEA-registered practitioners to 

prescribe Schedule II–V controlled 

substances via telemedicine through 

December 31, 2024, whether or not the 

patient and practitioner established a 

telemedicine relationship on or before 

November 11, 2023. In other words, the 

grace period provided in the First 

Temporary Rule was effectively 

subsumed by this Second Temporary 

Rule, which continued the extension of 

the current flexibilities for all 

practitioner-patient relationships—not 

just those established on or before 

November 11, 2023—until the end of 

2024. The purpose of the Second 

Temporary Rule, like the one before it, 

was to ensure a smooth transition for 

patients and practitioners that have 

come to rely on the availability of 

telemedicine for controlled substance 

prescriptions, as well as to allow 

adequate time for providers to come into 

compliance with any new standards or 

safeguards that are promulgated as part 

of a final set of telemedicine regulations. 

Tribal Consultations. On June 13 and 

27, 2024, the Office of Tribal Justice, 

Department of Justice (OTJ) collaborated 

with DEA to host two virtual DOJ 

Government-to-Government Tribal 

Consultations to seek input from Tribal 

governments on the practice of 

telemedicine within American Indian/ 

Alaskan Native (AI/AN) communities. 

OTJ and DEA invited the Tribal leaders 

of all federally recognized Tribes using 

the Bureau of Indian Affairs Tribal 

Leaders Directory, and provided a 

framing paper detailing the flexibilities, 

public engagement, and regulatory 

actions taken by DEA in recent years 

concerning telemedicine. OTJ and DEA 

invited Tribal input on any question or 

topic of interest related to the use of 

telemedicine by AI/AN communities, 

and specifically requested input on 

potential regulatory requirements and 

suggestions on what would help Tribal 

governments implement and comply 

with a future rule. OTJ and DEA also 

welcomed the submission of any written 

comments as well. 

III. Need for Further Rulemaking: 

Special Registration for Telemedicine 

In the process of reviewing and 

evaluating the comments to the 


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6546 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

25 21 U.S.C. 831(h)(1)(A). 

26 Majority of Physicians Worry Signs of 

Addiction Were Missed During Pandemic, Finds 

New Quest Diagnostics Health Trends Report, Quest 

Diagnostics (Nov. 15, 2021), https://newsroom.quest

diagnostics.com/2021-11-15-Majority-of-PhysiciansWorry-Signs-of-Addiction-Were-Missed-DuringPandemic,-Finds-New-Quest-Diagnostics-HealthTrends-R-Report#assets_30649_137302-130:199. 

While a survey conducted on behalf of a diagnostics 

services company, such as Quest Diagnostics, may 

carry the potential for bias—given the company’s 

potential preference for traditional in-person 

healthcare models—it still offers valuable insights, 

even if interpreted with some caution. When 

considered in context, such information still 

provides a unique data point, that when weighted 

accordingly, can inform this analysis. The results of 

the Harris Poll survey are further reinforced by a 

2024 National Center for Health Statistics (NCHS) 

Data Brief that shows the percentage of physicians 

who feel telemedicine fully provides the same care 

as in-person is 4.0 percent for primary care, 6.3 

percent for surgical specialty, and 6.0 percent for 

medical specialty. Myrick K, Mahar M, DeFrances 

CJ. Telemedicine Use Among Physicians by 

Physician Specialty: United States, 2021. NCHS 

Data Brief, no 493. (Feb. 2024), https://

www.cdc.gov/nchs/data/databriefs/db493.pdf. 

27 In June 2024, the founder and clinical president 

of a telehealth company were arrested for allegedly 

participating in a scheme to distribute Adderall and 

other stimulants online and conspiring to commit 

healthcare fraud. Specifically, they have been 

accused of arranging the prescription of over 40 

million pills of Adderall and other stimulants, often 

with no legitimate medical purpose. The company 

allegedly provided easy access to controlled 

substances in exchange for a monthly subscription 

fee, leading to tragic consequences, including 

overdoses and deaths. These allegations underscore 

DEA’s need to judiciously evaluate when a 

practitioner has a legitimate need for a Special 

Registration, and to ensure that any rule 

permanently authorizing telemedicine contains 

sufficient safeguards. Founder/CEO and Clinical 

President of Digital Health Company Arrested for 

$100M Adderall Distribution and Health Care 

Fraud Scheme, U.S. Department of Justice, Press 

Release Number: 24–752 (June 13, 2024), https://

www.justice.gov/opa/pr/founderceo-and-clinicalpresident-digital-health-company-arrested-100madderall-distribution. 

28 21 U.S.C. 831(h)(1)(B). 

29Proposed 21 CFR 1300.04 defines a special 

registration prescription to mean ‘‘a prescription, 

defined under [21 CFR 1300.01], for controlled 

substances issued under a practitioner’s Special 

Registration for Telemedicine for a legitimate 

medical purpose in the usual course of professional 

practice through the utilization of an audio-video 

telecommunications system defined in § 1300.04 of 

this chapter. 

30Under some circumstances, a special registrant 

may operate under a state reciprocity agreement or 

other form of state permission that would authorize 

the special registrant to comply only with the 

normally applicable law or regulations of either the 

state in which they are registered or the state in 

which they are practicing. In other words, states 

may deem compliance with one state’s normally 

applicable law and regulations as compliance with 

both states’ laws and regulations. In this context, 

DEA would understand the special registrant to be 

complying with both states’ laws and regulations, 

because the special registrant’s prescribing of 

controlled substances would be authorized by both 

states. 

31 Dewey C. MacKay, 75 FR 49956, 49973 (2010), 

aff’d, MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011). 

32 Id. 

proposed 2023 General Telemedicine 

NPRM and Buprenorphine NPRM, as 

well as the presentations made by 

various stakeholders at the 

Telemedicine Listening Sessions, DEA 

has determined that the best course of 

action to ensure patient access to care, 

while maintaining sufficient safeguards 

to detect and protect against the 

diversion of controlled substances, is to 

establish and maintain a separate 

Special Registration for Telemedicine 

(also referred to as simply ‘‘Special 

Registration’’), i.e., the regulatory 

scheme Congress specifically authorized 

in 21 U.S.C. 802(54)(E) and 21 U.S.C. 

831(h). As compared to the pre-COVID– 

19 PHE landscape, the Special 

Registration proposed herein would 

allow more comprehensive prescribing, 

including prescribing of Schedule II 

narcotics and non-narcotic controlled 

substances in limited circumstances, by 

properly registered clinician 

practitioners and dispensing by 

platform practitioners with a legitimate 

need for the Special Registration. 

In determining when a Special 

Registration should be issued under 21 

U.S.C. 802(54)(E), DEA must consider 

the criteria set forth in 21 U.S.C. 831(h). 

First, DEA must evaluate a practitioner’s 

legitimate need for such a Special 

Registration, as well as clearly define 

the limited circumstances under which 

a Special Registration is appropriate.25

These statutory requirements emphasize 

the need for careful consideration when 

extending prescribing privileges through 

telemedicine. This evaluation is crucial 

in determining whether telemedicine 

serves a necessary role, especially given 

the heightened risks of diversion and 

inappropriate prescribing of controlled 

substances posed by remote services 

where a patient has never undergone an 

in-person medical evaluation with the 

prescribing practitioner. 

While the COVID–19 PHE created a 

genuine need for increased use of 

telemedicine, it also highlighted the 

inherent risks associated with remote 

prescribing, particularly in the absence 

of in-person medical evaluations. In a 

2021 Harris Poll online survey 

conducted on behalf of Quest 

Diagnostics, 67 percent of physicians 

expressed concerns about missing signs 

of drug use or use disorders during the 

COVID–19 PHE, and 75 percent of 

physicians felt that telemedicine 

constrained their ability to assess 

whether patients were at risk of, or 

already, misusing prescription drugs.26

Although the telemedicine flexibilities 

during the PHE allowing practitioners to 

prescribe controlled substances without 

prior in-person medical evaluations 

were necessary to prevent lapses of care 

amid a global pandemic, it also 

facilitated the emergence of concerning 

business models engaged in the 

widespread diversion of controlled 

substances, taking advantage of the 

flexibilities established during the 

COVID–19 PHE.27

Second, DEA may only issue a Special 

Registration if the practitioner is 

‘‘registered under 21 U.S.C. 823(g) in the 

state which the patient will be located’’ 

when receiving the telemedicine 

treatment, unless the practitioner is 

excepted from 823(g) registration.28

Such 823(g) registration in the patient’s 

state is a critical validation of the 

practitioner’s qualifications and 

expertise in prescribing controlled 

substances within a given state. 

Moreover, the definition of ‘‘practice of 

telemedicine’’ under the Ryan Haight 

Act requires the practitioner to engage 

in the practice of medicine only ‘‘in 

accordance with applicable Federal and 

state laws.’’ A special registrant under 

this proposed framework would need to 

continue to comply with the laws and 

regulations of the state in which 

registered, and the laws and regulations 

of the state in which they are issuing 

special registration prescriptions 29 via a 

telemedicine encounter. Thus, where 

one state’s law and regulations are more 

restrictive than the other state’s law and 

regulations, the special registrant would 

be required to follow the more 

restrictive state law and regulations.30

Third, in all instances, clinician 

practitioners ‘‘must establish and 

maintain a bonafide doctor-patient 

relationship in order to act ‘in the usual 

course of . . . professional practice’ and 

to issue a prescription for a ‘legitimate 

medical purpose.’ ’’ 31 The ‘‘usual course 

of professional practice’’ is defined by 

the state in which a registrant practices, 

because ‘‘[c]onsistent with the CSA’s 

recognition of the State’s primary role in 

regulating the practice of medicine, the 

[CSA] generally looks to State law and 

standards of medical practice to 

determine whether a doctor and patient 

have established (and are maintaining) a 

bonafide doctor-patient relationship’’ at 

the time of the prescription.32

Direct-to-Consumer Online 

Telemedicine Platforms. In today’s 

rapidly evolving healthcare landscape, 

third-party online telemedicine 

platforms play a large and integral role, 

as intermediaries, in the delivery of 

remote healthcare to patients beyond 

traditional medical settings, with a shift 

towards predominantly virtual 

interactions. Many of these online 

telemedicine platforms employ a directto-consumer (‘‘DTC’’) business model in 

which they introduce or connect 


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33 21 U.S.C. 802(10). 

34Public Law 91–513 and 21 U.S.C. 802(21). The 

definition of practitioner has also remained 

unchanged since the enactment of the original CSA. 

35See Senate Report 110–521, Ryan Haight 

Online Pharmacy Consumer Protection Act of 2007, 

accompanying S.980, November 17, 2008 

(providing ‘‘[c]ertain telemedicine practices are 

exempted from the in-person medical evaluation 

requirement. The Committee recognizes that 

telemedicine is a practice tool that can improve 

health outcomes and reduce costs. It is not the 

intent of the Committee to restrict the legitimate 

practice of telemedicine or the emerging practices 

of telemedicine which are consistent with medical 

practice guidelines of the State in which the 

practitioner is licensed, provided such practices do 

not contravene the goal of effectively controlling the 

diversion of controlled substances’’). 

36 In addition to these two telepresenter 

categories, Congress created two additional 

regulatory categories (the special registration 

category and the joint rule category) to allow DEA 

to carry out its diversion control mission in light 

of future industry developments. See Senate Report 

110–521, Ryan Haight Online Pharmacy Consumer 

Protection Act of 2007, accompanying S.980, 

November 17, 2008 (noting that the statute provides 

that the Attorney General and the Secretary of 

Health and Human Services may promulgate 

regulations that allow for the full practice of 

telemedicine consistent with medical practice 

guidelines, so long as these regulations continue to 

effectively control diversion). 

patients with a remote clinician 

practitioner enabling the patient to be 

‘‘seen’’ anywhere using a computer or 

smart phone, forgoing the need for the 

patient to go to a medical facility to use 

the facility’s telecommunications 

system. 

Today’s DTC online telemedicine 

platforms often engage in marketing to 

attract new patients, whom they then 

introduce or match with clinician 

practitioners under the platforms’ direct 

employment or contract. The payment 

arrangements between the patient and 

the platform vary, but some platforms 

offer subscriptions, where patients pay 

a monthly fee for virtual consultations, 

sometimes up to and including an 

unlimited number of consultations, with 

a clinician practitioner. Often, but not 

always, the online telemedicine 

platform may own and operate the 

virtual environment, including the 

telecommunications system, where the 

patient and practitioner virtually 

‘‘meet,’’ providing the technological 

infrastructure or support. Unlike 

traditional medical settings, the 

clinician practitioner conducts the 

medical evaluation remotely, after 

which they may prescribe medications, 

including controlled substances. While 

the DTC online telemedicine platforms 

are not entirely new, they proliferated in 

recent years, in large part due to the 

COVID–19 pandemic. 

Dispensing by Practitioners under the 

CSA. Although these third-party, DTC 

online telemedicine platforms do not 

directly prescribe to patients or 

physically dispense controlled 

substances to patients, certain 

platforms’ central involvement as 

intermediaries in the remote dispensing 

of controlled substances qualifies them 

as ‘‘practitioners’’ engaged in 

‘‘dispensing’’ under the CSA. Under the 

CSA, to ‘‘dispense’’ means ‘‘to deliver a 

controlled substance to an ultimate user 

or research subject by, or pursuant to 

the lawful order of, a practitioner, 

including the prescribing and 

administering of a controlled 

substance.’’ 33 This statutory definition 

encompasses not only the physical act 

of handing out medications, but the 

broader process of providing them to 

patients under the direction of a 

licensed healthcare provider. 

The online telemedicine platforms 

serving as intermediaries for the 

prescribing of controlled substances fall 

squarely within the CSA’s broad 

definition of ‘‘practitioner.’’ Under the 

CSA a ‘‘practitioner’’ means ‘‘a 

physician, dentist, veterinarian, 

scientific investigator, pharmacy, 

hospital, or other person licensed, 

registered, or otherwise permitted, by 

the United States or the jurisdiction in 

which he practices or does research, to 

distribute, dispense, conduct research 

with respect to, administer, or use in 

teaching or chemical analysis, a 

controlled substance in the course of 

professional practice or research.’’ 34

According to this statutory definition, a 

‘‘practitioner’’ is not limited solely to 

individual healthcare providers, but 

also encompasses entities permitted by 

law to distribute or dispense controlled 

substances. Furthermore, considering 

the evolving nature of healthcare 

delivery, recognizing certain DTC online 

telemedicine platforms as practitioners 

engaged in dispensing under the CSA 

reflects the current landscape of 

telemedicine practice and ensures that 

DEA’s regulations remain relevant and 

responsive to changes in healthcare 

technology.35

DEA Registration of Intermediaries. 

The registration of telemedicine 

intermediaries is not a novel concept. In 

fact, when Congress amended the CSA 

with the Ryan Haight Act, it recognized 

the integral role telepresenters, serving 

as intermediaries, played in certain 

telemedicine models. In 21 U.S.C. 

802(54)(A)–(B), Congress specifically 

authorized two categories of 

telemedicine, both involving an 

intermediary healthcare provider 

facilitating a medical evaluation 

between a patient and a clinician 

practitioner located at a distance. Such 

intermediaries, in this context, are 

referred to as telepresenters. To uphold 

the integrity of the closed system, 

Congress required that such 

telepresenters, as intermediaries, be 

registered with DEA. Registration, the 

cornerstone of the closed system, helps 

to ensure that such intermediaries are 

qualified and accountable to DEA, 

reducing the risk of vulnerabilities or 

loopholes in this closed system that 

could lead to diversion and abuse of 

controlled substances.36

Special Registration of Certain DTC 

Online Telemedicine Platforms. Certain 

modern DTC online telemedicine 

platforms of today, which play a 

substantial and integral role as 

intermediaries in the remote dispensing 

of controlled substances, also require 

registration with DEA. These platforms 

are indispensable for delivering 

telemedicine services directly to 

patients through virtual platforms, in 

contrast to the other telemedicine 

models such as those that utilize 

telepresenters under 21 U.S.C. 

802(54)(A)–(B). The necessity for 

oversight of these newer telemedicine 

intermediaries is heightened by 

concerns arising from business practices 

that have come to light during and after 

the COVID–19 pandemic. These 

practices include platforms that 

incentivize the prescription of 

controlled substances to patients by 

practitioners and the exertion of control 

over the medications prescribed to 

patients. DEA has been informed by 

some clinicians that there have been 

instances when they terminated their 

relationship with an online 

telemedicine platform and, in doing so, 

forfeited access to their patient’s 

medical records stored by the platform. 

This renders such records noncompliant with DEA regulations, which 

mandate that the records be readily 

retrievable by the practitioner, because 

they become entirely inaccessible to the 

clinician practitioner. 

As discussed in further detail below, 

DEA is proposing the Special 

Registration of these DTC online 

telemedicine platforms when they meet 

the proposed regulatory definition of a 

covered online telemedicine platform. 

DEA is proposing a definition for 

covered online telemedicine platform, 

delineating the criteria that indicate 

their substantial and integral role as 

intermediaries in the remote dispensing 

of controlled substances, qualifying 

them as practitioners engaged in 

dispensing under the CSA and subject 

to the requirements imposed upon nonVerDate Sep<11>2014 11:02 Jan 17, 2025 Jkt 265001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 E:\FR\FM\17JAP2.SGM 17JAP2

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37See supra footnote 15. 

38The behaviors listed in these four factors are 

included solely to determine whether a platform is 

serving as an integral intermediary. Federal, state, 

or local laws and/or regulations may impose 

statutory or regulatory requirements related to these 

behaviors. The inclusion of these behaviors in the 

definition of covered online telemedicine platform 

does not indicate that such behaviors are permitted 

under any particular law or regulation. 

39The definition of covered online telemedicine 

platform and the four criteria are discussed in 

further detail below in the NPRM’s discussion of 

proposed regulatory definitions. 

40Ryan Haight Online Pharmacy Consumer 

Protection Act of 2008, Public Law 110–425, 122 

Stat. 4820, § 3(a) (2008) (codified as amended in 21 

U.S.C. 802(54)(E)). 

41This is an important distinction given potential 

conflation between colloquial use of the term 

‘‘telemedicine’’ and the statutory definition of the 

‘‘practice of telemedicine’’ in the CSA and these 

proposed regulations. To illustrate this point, the 

following scenarios are non-exhaustive examples in 

which ‘‘telemedicine’’ may occur in the colloquial 

sense but would not constitute the ‘‘practice of 

telemedicine’’ under the CSA or these proposed 

regulations: (1) a practitioner issues a prescription 

for a non-controlled substance; (2) a practitioner 

treats the patient through audio-visual means and, 

after doing so, determines the patient does not 

require controlled substances; or (3) a practitioner 

is a mental health counselor who treats patients 

using ‘‘talk therapy’’ exclusively, without 

prescribing controlled substances. 

42 21 U.S.C. 802(2) defines ‘‘administer’’ to mean 

the ‘‘direct application of a controlled substance to 

the body of a patient or research subject by a 

practitioner (or, in his presence, by his authorized 

agent), or the patient or research subject at the 

direction and in the presence of the practitioner, 

whether such application be by injection, 

inhalation, ingestion, or any other means.’’ 

pharmacist practitioners 37 under the 

Controlled Substances Act and its 

regulations. 

When any one of the four outlined 

factors are present, it solidifies the 

platform’s role as an integral 

intermediary in the remote dispensing 

of controlled substances.38 The 

proposed definition and criteria are 

intended to provide a practical and clear 

framework for identifying when a DTC 

online telemedicine platform’s conduct 

qualifies them as a covered online 

telemedicine platform, mandating 

registration as a dispenser with DEA.39

As proposed, this definition is intended 

to limit the Special Registration 

requirements only to those DTC online 

telemedicine platforms that play a 

substantial and integral role as 

intermediaries in the remote dispensing 

of controlled substances. 

The definition of covered online 

telemedicine platform also explicitly 

excludes certain types of entities, 

including hospitals, clinics, insurance 

providers, and local in-person medical 

practices. Local in-person medical 

practice is, in turn, defined by this rule 

to be a medical practice where all its 

offices are within 100 miles of each 

other, and where less than 50 percent of 

the total prescriptions for controlled 

substances collectively issued by the 

practice’s physicians and mid-level 

practitioners are issued via telemedicine 

in any given calendar month, but is not 

a hospital, clinic, or insurance provider. 

The type of entities excluded from the 

definition of covered online 

telemedicine platform are entities that 

engage in conduct that could potentially 

fall under the definition’s criteria but 

are not the types of entities whose 

primary business operations rely on, or 

center around, telemedicine services. 

Moreover, it should be noted that the 

proposed definition of local in-person 

medical practice uses the term 

‘‘telemedicine’’ rather than ‘‘practice of 

telemedicine.’’ This distinction is 

significant, as ‘‘telemedicine’’ is used in 

its general, colloquial sense, whereas 

the ‘‘practice of telemedicine’’ carries 

the specific statutory meaning defined 

by the Ryan Haight Act. 

Determining whether an entity 

dispenses controlled substances and 

meets the criteria of a covered online 

telemedicine platform is a fact-specific 

inquiry. If there is any uncertainty 

regarding the entity’s role as a 

dispenser, particularly concerning its 

involvement in the practitioner-patient 

relationship, registering may be 

advisable to avert the risk of 

enforcement action based on potential 

unregistered, and thus illegal, 

dispensing of controlled substances. 

IV. Section-by-Section Discussion of 

Proposed Rule 

The proposed regulations discussed 

below are designed to satisfy the 

statutory mandates of 21 U.S.C. 831(h) 

and 21 U.S.C. 802(54)(E), while 

fulfilling DEA’s core responsibilities of 

regulating controlled substances and 

adapting to the evolving landscape of 

telemedicine, including the rise of new 

types of DTC online telemedicine 

platforms engaged in dispensing of 

controlled substances. Before discussing 

the proposed regulations, it is important 

to once again highlight what they do not 

govern or permit. First, as emphasized 

previously, the proposed regulations do 

not affect practitioner-patient 

relationships in cases where an inperson medical evaluation has occurred 

at any point within the relationship. 

Once an in-person medical evaluation 

has taken place, the practitioner-patient 

relationship falls outside the scope of 

the Ryan Haight Act and the DEA 

regulations implementing the Ryan 

Haight Act. Second, these proposed 

regulations primarily focus on the 

practice of telemedicine under the 

Special Registration framework 

authorized by the Ryan Haight Act.40

Other categories of telemedicine 

established by the Ryan Haight Act, 

such as telemedicine occurring during a 

public health emergency declared by 

HHS as authorized under 21 U.S.C. 

802(54)(D), are not subject to the 

registration, prescription, and 

recordkeeping and reporting regulations 

proposed in this NPRM. 

Third, these proposed regulations 

would not apply in the absence of a 

prescription for controlled substances.41

In other words, practitioners would not 

be required to obtain a Special 

Registration unless they wish to 

prescribe or otherwise dispense 

controlled substances to patients via 

telemedicine encounters. And fourth, 

the proposed regulations would only 

permit the prescribing of controlled 

substances through telemedicine by 

clinician practitioners. Under the 

Special Registration framework, 

clinician practitioners would not be 

authorized to engage in other modes of 

‘‘dispensing,’’ such as ‘‘administering’’ 

controlled substances to patients via 

telemedicine.42

A. Registration Requirements Under 21 

CFR Part 1301 

As discussed earlier, registration is 

the cornerstone of the closed system of 

control for manufacturing, distribution, 

and dispensing of controlled substances, 

and requires any person who 

manufactures, distributes, dispenses, 

imports, exports, or conducts research 

or chemical analysis with controlled 

substances to register with DEA, unless 

otherwise exempted. Establishing a 

Special Registration for telemedicine 

would enhance patient access to care by 

allowing certain practitioners to 

prescribe controlled substances via 

telemedicine without the limitations of 

geographical barriers. At the same time, 

it would establish the appropriate 

circumstances and guardrails for 

telemedicine-based prescribing and 

dispensing of controlled substances 

where an in-person medical evaluation 

has never been performed by the 

prescribing practitioner. The rise of DTC 

online telemedicine platforms in recent 

years has further transformed healthcare 

delivery, but it has also introduced new 

challenges and heightened risks of 

diversion due to the remote nature of 

care delivery. The proposed registration 

requirements for telemedicine-based 

prescribing and dispensing create a new 

business activity within DEA’s 

overarching registration framework, 

distinguishing it from the traditional 

modes of dispensing under a 21 U.S.C. 

823(g) registration. 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6549 

43Proposed 21 CFR 1301.11. 

44 21 U.S.C. 831(h)(1)(A). 

45 Id.; 831(h)(2)(A). 

46Proposed 21 CFR 1301.11(c)(2). 

47Proposed 21 CFR 1301.11(c)(3). 

48See 21 U.S.C. 812(b)(2), (3). 

49Proposed 21 CFR 1301.11(c)(4). 

50 21 CFR 1301.23(a) waives the requirement of 

registration ‘‘for any official of the U.S. Army, Navy, 

Marine Corps, Air Force, Space Force, Coast Guard, 

Public Health Service, or Bureau of Prisons who is 

authorized to prescribe, dispense, or administer, but 

not to procure or purchase, controlled substances in 

the course of his/her official duties.’’ 

51Proposed 21 CFR 1306.45(e) would also require 

that the parent or guardian of patients under the age 

of 18 be present in the room with the patients when 

the patients are being issued prescriptions for a 

Schedule II controlled substance. 

1. Three Types of Special Registration; 

Registrant Eligibility 

The proposed requirements for the 

Special Registration 43 are devised to 

meet the statutory requirements of 21 

U.S.C. 831(h). This provision authorizes 

DEA to issue a Special Registration if 

the practitioner demonstrates a 

legitimate need for a Special 

Registration.44 Moreover, this statutory 

provision requires DEA to promulgate 

regulations specifying the limited 

circumstances under which a Special 

Registration may be issued and establish 

clear eligibility criteria for practitioners 

and the procedure for seeking a Special 

Registration.45 To accommodate the 

varying legitimate needs of 

practitioners, including both clinician 

practitioners and covered online 

telemedicine platforms, in their capacity 

as platform practitioners, the proposed 

framework offers three distinct 

categories of Special Registrations. 

The first category, the Telemedicine 

Prescribing Registration, would 

authorize the prescribing of Schedules 

III through V controlled substances by 

clinician practitioners.46 The second 

category, the Advanced Telemedicine 

Prescribing Registration, would 

authorize certain specialized clinician 

practitioners the privilege to prescribe 

not only Schedule III through V 

controlled substances, but Schedule II 

controlled substances as well,47 even 

though such substances have higher 

potential for abuse and dependence.48

And lastly, the third category, the 

Telemedicine Platform Registration, 

would authorize covered online 

telemedicine platforms to dispense 

Schedules II through V controlled 

substances through a clinician 

practitioner possessing either a 

Telemedicine Prescribing Registration or 

an Advanced Telemedicine Prescribing 

Registration.49

Under proposed § 1301.11(c)(1)(A), an 

applicant for one of the three types of 

Special Registration would be required 

to already have one or more DEA 

registrations under 21 U.S.C. 823(g) to 

prescribe (if an clinician practitioner) or 

dispense (if a platform practitioner) 

controlled substances in a state in 

which they are licensed, registered, or 

otherwise permitted to prescribe or 

dispense controlled substances through 

telemedicine, unless they are otherwise 

exempted. 

This requirement for Special 

Registration streamlines the review and 

approval process for applications for 

Special Registrations by building upon 

the checks and assessments already 

conducted for 21 U.S.C. 823(g) 

registrations. While the proposed 

framework allows for VA practitioners 

to seek and obtain a Special 

Registration, DEA and HHS have also 

jointly promulgated the Continuity of 

Care via Telemedicine for Veterans 

Affairs Patients final rule (RIN 1117– 

AB88), published elsewhere in this 

issue of the Federal Register, which 

specifically addresses the practice of 

telemedicine within the VA health care 

system. As discussed above, a DTC 

online telemedicine platform that 

qualifies as a covered online 

telemedicine platform dispenses 

controlled substances and must register 

with DEA in its capacity as a dispenser. 

It also bears emphasizing that proposed 

§ 1301.11(c)(1) requires that covered 

online telemedicine platforms, like their 

clinician practitioner counterparts, 

already have one or more DEA 

registrations under 21 U.S.C. 823(g) to 

dispense controlled substances; DEA 

registrations under 21 U.S.C. 823(g) in 

turn require licensing of the activity by 

the state in which DEA registration 

under 21 U.S.C. 823(g) is sought. 

Proposed § 1301.11(c)(1)(i) makes it 

clear that those officials for whom the 

requirement of registration to prescribe 

is generally waived under § 1301.23(a) 

of this chapter must still obtain a 

Telemedicine Prescribing Registration or 

Advance Telemedicine Prescribing 

Registration before issuing special 

registration prescriptions.50 Such 

officials are, as described below, exempt 

from obtaining State Telemedicine 

Registrations, though they must identify 

all the states in which patients will be 

treated via telemedicine on their 

registration application. 

a. Telemedicine Prescribing Registration 

(Schedules III–V) Clinician Practitioners 

Eligibility 

To be eligible for the Telemedicine 

Prescribing Registration under proposed 

§ 1301.11(c)(2), clinician practitioners 

would need to demonstrate that they 

have a legitimate need for a Special 

Registration. DEA has determined that 

physicians and board-certified mid-level 

practitioners (defined under 21 CFR 

1300.01) have a legitimate need to 

prescribe Schedules III through V 

controlled substances when they 

anticipate that they will be treating 

patients for whom requiring in-person 

medical evaluations prior to prescribing 

Schedule III–V controlled substances 

could impose significant burdens on 

bona fide practitioner-patient 

relationships. For example, practitioners 

may have a legitimate need for the 

Special Registration when their patients 

face significant challenges in attending 

in-person medical evaluations, such as 

severe weather conditions, living in 

remote or distant areas, or having 

communicable diseases, which make inperson appointments difficult or even 

unadvisable. 

b. Advanced Telemedicine Prescribing 

Registration (Schedules II–V) Clinician 

Practitioner Eligibility 

To be eligible for the Advanced 

Telemedicine Prescribing Registration 

under proposed § 1301.11(c)(3), 

physicians and mid-level practitioners, 

as clinician practitioners, would not 

only need to demonstrate they have a 

legitimate need for the Special 

Registration but that such need warrants 

the authorization of prescribing of 

Schedule II controlled substances in 

addition to Schedules III through V 

controlled substances. DEA has 

determined that certain specialized 

physicians and board-certified mid-level 

practitioners have a legitimate need to 

prescribe Schedule II controlled 

substances via telemedicine when 

treating particularly vulnerable patient 

populations. Such authorization is 

reserved only for the most compelling 

use cases, ensuring that Schedule II 

prescribing via telemedicine is used 

only when necessary. 

Consistent with these concerns 

regarding vulnerable patient 

populations, and cognizant of the high 

potential for abuse that exists for 

Schedule II controlled substances, DEA 

has determined that only certain 

specialized physicians and boardcertified mid-level practitioners have a 

legitimate need for the Advanced 

Telemedicine Prescribing Registration, 

in the following limited circumstances 

or practice specialties: 

(1) psychiatrists; 

(2) hospice care physicians; 

(3) palliative care physicians; 

(4) physicians rendering treatment at 

long term care facilities; 

(5) pediatricians; 51


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
6550 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

52See Telemedicine Listening Sessions, Georgia 

Gaveras (Talkiatry), 21:6–22:4, 25:1–8 (Sept. 12, 

2023); John Heaphy (NY State Dep. of Health, 

Mental Health), 76:10–77:14 (Sept. 13, 2023); and 

Caitlin Gilloley (American Hospital Association), 

63:21–64:14 (Sept. 13, 2023). 

53See Telemedicine Listening Sessions, David 

Hoffman (Columbia University), 44:17–44:23, 

45:16–21, 46:19–21 (Sept. 12, 2023); Robin Plumer, 

M.D., 190:18–191:17 (Sept. 12, 2013); Kevin Duane, 

PharmD, 206:16–207:1 (Sept. 12, 2023); Joseph 

Rotella, M.D. (American Academy of Hospice and 

Palliative Medicine), 289:25–290:12 (Sept. 12, 

2023); Alex Armitage, M.D. (Baylor Scott & White 

Health), 43:8–14, 43:24–44:10 (Sept. 13, 2023); and 

Caitlin Gilloley (American Hospital Association), 

63:21–64:14 (Sept. 13, 2023). 

54See Appendix B for Chart: Which Special 

Registration for Telemedicine Do I Need as a 

Clinician Practitioner? 

55Bollmeier SG, Stevenson E, Finnegan P, Griggs 

SK. Direct to Consumer Telemedicine: Is Healthcare 

from Home Best? Mo Med. 2020 Jul– 

Aug;117(4):303–309. PMID: 32848261; PMCID: 

PMC7431063. See also, Temporary Extension of 

COVID–19 Telemedicine Flexibilities for 

Prescription of Controlled Medications, 88 FR 

30037, 30040 (May 10, 2023). As discussed in the 

First Temporary Rule, while the conduct of certain 

online telemedicine platforms has raised concerns 

and such platforms may be subject to investigation 

for problematic prescribing practices, many others 

have acted in good faith to expand access to care. 

‘‘Doctor shopping is defined as seeing multiple 

treatment providers, either during a single illness 

episode or to procure prescription medications 

illicitly.’’ Sansone RA, Sansone LA. Doctor 

shopping: a phenomenon of many themes. Innov 

Clin Neurosci. 2012 Nov;9(11–12):42–6. PMID: 

23346518; PMCID: PMC3552465. 

(6) neurologists; and 

(7) mid-level practitioners and 

physicians from other specialties who 

are board certified in the treatment of 

psychiatric or psychological disorders, 

hospice care, palliative care, pediatric 

care, or neurological disorders unrelated 

to the treatment and management of 

pain. 

The type of specialized practitioners 

and board-certified mid-level 

practitioners eligible for the Advanced 

Telemedicine Prescribing Registration 

typically treat patients that face 

significant healthcare accessibility 

challenges, and, in some cases, who 

suffer from particularly debilitating or 

terminal illnesses. The hardships faced 

by such patients were discussed at 

length by certain speakers during the 

Telemedicine Listening Sessions. For 

example, some speakers discussed 

accessibility issues created by shortages 

of psychiatrists, and the need for 

qualified, perhaps board-certified, 

psychiatrists to diagnose and treat 

illnesses like ADHD.52 Another group of 

speakers addressed the accessibility 

challenges faced by palliative and 

hospice patients, often homebound, 

who may need urgent pain treatment 

and symptom management.53 The 

heightened specificity of these limited 

circumstances is intended to strike a 

balance between ensuring access to 

necessary medications for vulnerable 

patients while controlling the 

prescribing of Schedule II controlled 

substances that have a higher potential 

risk of abuse and dependence. 

Furthermore, these eligible 

specialized physicians and boardcertified mid-level practitioners are 

uniquely positioned to provide expert 

care for specific, vulnerable patient 

populations. These specialized 

physicians and mid-level practitioners 

have specialized training and in-depth 

knowledge to equip them to make 

informed decisions regarding the use of 

Schedule II controlled substances when 

prescribed remotely to particularly 

vulnerable patient groups. While DEA is 

not proposing regulations that delineate 

specific criteria for practitioners falling 

into the designated practice specialties, 

clinician practitioners are required to 

furnish information on their Special 

Registration applications that would 

demonstrate their specialized training. 

For example, the clinician practitioner 

could cite or provide information on 

board certification in a specialty, 

specialized training, or the percentage of 

the clinician practitioner’s overall 

practice that falls within one of the 

specialized practices. Mid-level 

practitioners are, however, required to 

be board-certified under this proposed 

framework. DEA invites public 

comments on all facets of the proposed 

regulations, including this specific 

provision.54 Particularly, DEA seeks 

input on whether other types of 

practitioners should be included if they 

can demonstrate specific training in 

expertise in managing conditions that 

are traditionally treated with Schedule 

II controlled substances. DEA also seeks 

input on alternative methods to ensure 

that practitioners seeking to prescribe 

Schedule II controlled substances 

pursuant to the Advanced Telemedicine 

Prescribing Registration have the 

appropriate training and expertise to do 

so safely. 

c. Telemedicine Platform Registration 

(Schedules II–V) Platform Practitioner 

Eligibility 

To be eligible for the Telemedicine 

Platform Registration under proposed 

§ 1301.11(c)(4), covered online 

telemedicine platforms would need to 

demonstrate that they have a legitimate 

need for a Special Registration. DEA has 

determined that covered online 

telemedicine platforms (defined under 

21 CFR 1300.04), in their capacity as 

platform practitioners, have a legitimate 

need to dispense Schedules II through V 

controlled substances when they 

anticipate providing necessary services 

to introduce or facilitate connections 

between patients and clinician 

practitioners via telemedicine for the 

diagnosis, treatment, and prescription of 

controlled substances, are compliant 

with federal and state regulations, 

provide oversight over clinician 

practitioners’ prescribing practices, and 

take measures to prioritize patient safety 

and prevent diversion, abuse, or misuse 

of controlled substances. The platform 

practitioner would be required to attest 

to its legitimate need on their special 

registration application. If, however, it 

is later discovered that the practitioner 

provided false information to obtain the 

special registration or used it for 

unlawful or inappropriate purposes, the 

practitioner could be found in violation 

of 21 U.S.C. 824(a), which could lead to 

penalties such as revocation or 

suspension of the registration. 

As discussed previously, the 

registration of covered online 

telemedicine platforms within the 

Special Registration framework is 

necessary given the pivotal role they 

sometimes play in the delivery of 

healthcare through telemedicine. While 

these covered online telemedicine 

platforms may improve healthcare 

accessibility by connecting patients 

with clinician practitioners, their 

emergence also brings more, and 

sometimes easier, avenues to divert or 

abuse controlled substances, 

particularly when such entities have 

financial incentives tied to prescriptions 

and/or do not adequately screen the 

clinician practitioners utilizing their 

system or platform. The lack of proper 

oversight and verification of clinician 

practitioners’ credentials open the door 

to ‘‘doctor shopping’’ 55 on the systems 

or platforms, particularly when bad 

actors are aware of, and exploit, the lack 

of oversight and credential verification 

by covered online telemedicine 

platforms. 

2. Ancillary Registration: State 

Telemedicine Registrations 

Pursuant to 21 U.S.C. 802(54), the 

practice of telemedicine, including such 

practice authorized under a Special 

Registration, must be ‘‘in accordance’’ or 

consistent with Federal and State law. 

Section 831(h)(1)(B) authorizes DEA to 

issue a Special Registration to a 

practitioner if the practitioner is 

registered under 21 U.S.C. 823(g) in the 

state in which the patient is located 

when receiving a prescription for 

controlled substance via telemedicine (a 

‘‘823(g) patient state registration), 

subject to certain exceptions. While the 

proposed Special Registration 

framework must comply with these 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6551 

56Pursuant to 21 U.S.C. 822(d), ‘‘[t]he Attorney 

General may, by regulation, waive the requirement 

for registration of certain manufacturers, 

distributors, or dispensers if he finds it consistent 

with the public health and safety.’’ 

57 21 U.S.C. 802(54)(A)(ii)(III). 

58 21 U.S.C. 802(54)(A)(ii)(III)(bb). 

59 21 U.S.C. 831(h)(1)(B)(i)–(ii). 

60See Appendix C for Chart: Which State 

Telemedicine Registrations Do I Need, If Any? 

61 21 CFR 1301.21 exempts certain clinician 

practitioner applicants from payment of application 

fees for registration, including for Special 

Registrations and State Telemedicine Registrations. 

statutory provisions, DEA is mindful 

that telemedicine is largely designed to 

overcome geographical constraints. 

Therefore, to reduce the administrative 

burden and cost on special registrants, 

DEA is proposing a limited type of 21 

U.S.C. 823(g) registration for a lower 

registration fee, the State Telemedicine 

Registration. 

Pursuant to proposed § 1301.11(d), a 

clinician special registrant would be 

required to obtain a State Telemedicine 

Registration, which is a DEA-issued 

registration and not a registration issued 

by the individual states, for every state 

in which they intend to issue 

prescriptions for controlled substances 

to patients via telemedicine. Likewise, a 

platform special registrant would be 

required to obtain a State Telemedicine 

Registration for every state in which it 

dispenses Schedule II–V controlled 

substances to a patient. The State 

Telemedicine Registration would 

operate as an ancillary credential, 

contingent on the Special Registration 

held by the clinician practitioner or 

platform practitioner. In other words, a 

State Telemedicine Registration for a 

given state would allow the special 

registrant to prescribe only via 

telemedicine encounters as to that state, 

and only for the scheduled controlled 

substances authorized by their Special 

Registration (i.e., Telemedicine 

Prescribing Registration, Advanced 

Telemedicine Prescribing Registration, 

or Telemedicine Platform Registration). 

Proposed 21 CFR 1301.11(d) 

stipulates that a practitioner’s eligibility 

for the State Telemedicine Registration 

for a specific state depends on their 

authorization, such as state licensure or 

state-level registration, to prescribe or 

otherwise dispense controlled 

substances through telemedicine within 

that state. Consistent with the criteria 

for all 823(g) registrations, DEA will 

consider the public interest factors 

outlined in 21 U.S.C. 823(g)(1)(A)–(E) 

before granting a State Telemedicine 

Registration. The requirement of state 

authorization aligns with 21 U.S.C. 

823(g)(1)(D), which assesses compliance 

with state, federal, and local laws 

regarding controlled substances. 

Exemptions to the State Telemedicine 

Registration Requirement. Section 21 

U.S.C. 831(h)(1)(B) does, however, 

provide two categories of exemptions to 

the state registration requirement. 

Generally, a clinician special registrant 

would not be required to obtain a 

section 823(g) registration in each 

patient state to prescribe via 

telemedicine, if the clinician special 

registrant is either: (1) subject to a 

regulatory exemption applicable to all 

states pursuant to 21 U.S.C. 822(d),56 or 

(2) the clinician special registrant is an 

employee or contractor of the VA.57

As to the first category of exemptions, 

there is currently one regulatory 

exemption, promulgated pursuant to 21 

U.S.C. 822(d), applicable to registration 

in all states. Specifically, 21 CFR 

1301.23(a) waives registration ‘‘for any 

official of the U.S. Army, Navy, Marine 

Corps, Air Force, Space Force, Coast 

Guard, Public Health Service, or Bureau 

of Prisons who is authorized to 

prescribe, dispense, or administer, but 

not to procure or purchase, controlled 

substances in the course of his/her 

official duties.’’ The second category of 

exemptions is the one explicitly 

extended to VA employees or 

contractors by statute.58 When an 

employee or contractor of the VA is 

acting in the scope of such employment 

or contract, and is registered under 

section 823(g) in any state or is utilizing 

the registration of a hospital or clinic 

operated by the VA registered under 21 

U.S.C. 823(g), the prescriber would not 

need to possess a State Telemedicine 

Registration in each state in which a 

patient is located.59

While proposed § 1301.11(d) 

incorporates these exemptions, those 

clinician practitioners who are 

exempted from the State Telemedicine 

Registration requirement remain subject 

to other Special Registration eligibility 

requirements and are required to 

identify all the states in which patients 

will be treated via telemedicine on their 

registration application for the 

Telemedicine Prescribing Registration or 

the Advanced Telemedicine Prescribing 

Registration. DEA must have this 

information to coordinate oversight and 

verify that State Telemedicine 

Registration-exempted clinician special 

registrants are operating within the 

boundaries of their exemption while 

upholding regulatory standards. The 

State Telemedicine Registrationexempted clinician special registrants 

would also be exempted from the $50 

fee per state under proposed 21 CFR 

1301.13(e)(1)(xiii), further discussed 

below.60

3. Special Registration Application 

Process 

The Special Registration application 

process for obtaining the proposed 

Telemedicine Prescribing Registration, 

Advanced Telemedicine Prescribing 

Registration, and the Telemedicine 

Platform Registration would differ from 

the standard 21 U.S.C. 823(g) 

registration application process. The 

proposed amendments to 21 CFR 

1301.13 outline the new Special 

Registration application requirements. 

a. Special Registration Application, 

Cycles, Fees, Generally 

Proposed 21 CFR 1301.13(e)(1)(xi)– 

(xv) summarizes the Special 

Registration Application, Cycle, and 

Fees. DEA proposes issuing a new 

registration application, Form 224S 

(Application for Special Registration for 

Telemedicine Under the Controlled 

Substances Act), tailored for Special 

Registrations. Special Registration 

applicants would use the Form 224S to 

apply for one of the three types of the 

Special Registration (i.e., Telemedicine 

Prescribing Registration, Advanced 

Telemedicine Prescribing Registration, 

or Telemedicine Platform Registration), 

as well as the State Telemedicine 

Registrations for each state in which 

telemedicine patients will be located. 

The regulations propose a tiered fee 

structure to address the administrative 

demands specific to the new business 

activities. The regulations propose a 

three-year cycle for the Special 

Registrations (i.e., Telemedicine 

Prescribing Registration, Advanced 

Telemedicine Prescribing Registration, 

and Telemedicine Platform 

Registration), as well as the State 

Telemedicine Registrations (i.e., 

Clinician Practitioner State 

Telemedicine Registration and the 

Platform Practitioner State 

Telemedicine Registration). 

For any one of the three types of 

Special Registration, the registration fee 

would be $888. The fee for the Platform 

Practitioner State Telemedicine 

Registration would be $888 for each 

state in which a State Telemedicine 

Registration is sought; however, the 

Clinician Practitioner State 

Telemedicine Registration would be 

discounted to $50 for each state in 

which the clinician practitioner sought 

a State Telemedicine Registration.61 The 

fee for the State Telemedicine 

Registration for clinician practitioners is 

discounted to account for the expected 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
6552 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

62Pursuant to 21 U.S.C. 821, DEA is authorized 

to charge reasonable fees relating to registration and 

control of the dispensing (including prescribing) of 

controlled substances. Furthermore, 21 U.S.C. 

886a(1)(C) requires those fees to be set at a level that 

ensures the recovery of the full costs of operating 

the various aspects of the Diversion Control. 

Program. For more information on fee scheduling, 

see Registration and Reregistration Fees for 

Controlled Substance and List I Chemical 

Registrants, 85 FR 44710–44734 (July 24, 2020). 

63See Proposed 21 CFR 1304.04(j). 

64See Telemedicine Listening Sessions, Dr. 

Shabana Khan (American Psychiatric Association 

and American Academy of Child and Adolescent 

Psychiatry), 38:16–19 (Sept. 12, 2023) 

(recommending that DEA could require the 

reporting of the prescriber’s employer to hold the 

telemedicine employers accountable). 

lower volume of telemedicine that 

would be conducted by clinician 

practitioners compared to covered 

online telemedicine platforms. The $50 

registration fee for the Clinician 

Practitioner State Telemedicine 

Registration would be waived for those 

exempted from registration pursuant to 

21 U.S.C. 831(h)(1)(B) and proposed 21 

CFR 1301.11(c)(3). In DEA’s preliminary 

assessment, the registration fees are 

reasonable and are expected to account 

for the full operating costs associated 

with the heightened administrative and 

resource demands on the Diversion 

Control Program that will arise from 

regulating a new registration class; 

however, DEA may adjust these fees as 

it acquires additional information about 

the new registration classes to ensure 

appropriate funding for regulatory 

oversight.62

b. Supplemental Requirements on 

Special Registration Application (Form 

224S) 

Special Registered Location. Pursuant 

to proposed § 1301.13(k)(1), all Special 

Registration applicants would be 

required to designate one of their 

existing 21 U.S.C. 823(g) registered 

locations as the registered location/ 

physical address (‘‘special registered 

location’’) of their Special Registration. 

The special registered location would 

serve as the physical point of contact for 

DEA telemedicine inquires and 

compliance actions. As will be further 

discussed below, the proposed rule 

would also mandate that the records 

arising from telemedicine encounters 

under the Special Registration be 

maintained at the special registered 

location.63 Such centralized 

recordkeeping would allow DEA to 

more efficiently review records and 

ensure that prescriptions are being 

issued in accordance with DEA 

regulations. Proposed § 1301.13(k)(1) 

would provide an exemption for 

applicants who are exempted from the 

State Telemedicine Registration 

requirement under proposed 

§ 1301.11(d); however, such exempted 

persons would be required to provide 

another physical address on the 

application to serve as their special 

registered location. 

Form 224S Supplementary 

Disclosures and Attestations. Proposed 

21 CFR 1301.13(k)(2) would require the 

Special Registration applicant to 

provide certain disclosures and 

attestations on the Form 224S. Such 

information would enhance 

transparency, patient safety, and antidiversion efforts. First, proposed 

§ 1301.13(k)(2)(i) would require 

platform practitioners applying for the 

Telemedicine Platform Registration to 

attest to all employment, contractual 

relationships, or professional affiliations 

with any clinician special registrant and 

Online Pharmacy and their respective 

registration numbers on the Form 224S. 

Likewise, proposed § 1301.13(k)(2)(ii) 

would require clinician practitioners 

applying for the Telemedicine 

Prescribing Registration or the 

Advanced Telemedicine Prescribing 

Registration to attest to all employment, 

contractual relationships, and 

professional affiliations, including but 

not limited to those with covered online 

telemedicine platforms (and the 

respective online telemedicine 

platform’s Telemedicine Platform 

Special Registration number, if 

applicable) on the Form 224S. By 

understanding each prescriber’s 

professional associations, DEA can more 

effectively evaluate the prescriber’s 

qualifications, conflicts of interest, and 

compliance with DEA regulations.64

Second, proposed § 1301.13(k)(2)(iii) 

would require that clinician 

practitioners and platform practitioners 

applying for a Special Registration to 

attest that they have devised, and are 

committed to maintaining, antidiversion policies and procedures. 

Third, proposed § 1301.13(k)(2)(iv) 

would require clinician practitioners 

applying for the Advanced 

Telemedicine Prescribing Registration to 

disclose their practice specialties, e.g. 

hospice care or palliative care. DEA 

would use this information in 

conjunction with other investigative 

information to help detect and prevent 

diversion of controlled substances via 

telemedicine. This would include 

circumstances where clinician 

practitioners appear to be prescribing 

medications for conditions unrelated to 

their practice specialties. DEA would 

also use this information as needed to 

check the applicant’s eligibility for the 

Advanced Telemedicine Prescribing 

Registration, which is limited to certain 

specialized physicians and mid-level 

practitioners treating vulnerable patient 

populations who have a legitimate need 

to prescribe Schedule II controlled 

substances. 

As discussed above, under the 

proposed 21 CFR 1301.11(c)(3), only 

psychiatrists, hospice care physicians, 

palliative care physicians, physicians 

rendering treatment at long term care 

facilities, pediatricians, neurologists, 

and mid-level practitioners board 

certified in the treatment of psychiatric 

or psychological disorders, hospice 

care, palliative care, pediatric care, or 

neurological disorders unrelated to the 

treatment and management of pain, 

would be eligible for the Advanced 

Telemedicine Prescribing Registration. 

Lastly, proposed § 1301.13(k)(2)(v) 

would require that, for each type of 

Special Registration, the applicant 

required to attest to their legitimate 

need on their special registration 

application. If, however, it is later 

discovered that practitioner provided 

false information to obtain the Special 

Registration or used it for unlawful or 

inappropriate purposes, they could be 

found in violation of 21 U.S.C. 824(a), 

which could lead to penalties such as 

revocation or suspension of registration. 

c. Notification of Application Changes; 

Modifications (Form 224S–M) 

Proposed 21 CFR 1301.13(l) would 

require special registrants to promptly 

notify DEA of any changes to the 

information provided in their original 

Special Registration application (Form 

224S) within 14 business days on a 

Form 224S–M (Application for Changes 

and Modifications to Special 

Registration). For example, if a clinician 

special registrant began employment 

with, or otherwise entered an 

arrangement with, a new DTC online 

telemedicine platform not previously 

disclosed on their original Form 224S, 

the clinician special registrant would be 

required to submit a Form 224S–M to 

DEA within 14 business days of any 

such change. The Form 224S–M would 

also be used by clinician special 

registrants and platform special 

registrants to make modifications to 

their Special Registration. For example, 

the special registrant would submit a 

Form 224S–M to apply for additional 

State Telemedicine Registrations to 

engage in telemedicine in states for 

which the special registrant did not 

originally apply on their Form 224S. 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6553 

65 28 CFR Pt. 0, Subpt. R., App., Sec. 7 delegates 

the authority to sign final orders connected with the 

suspension, denial, or revocation of registration to 

the Deputy Assistant Administrator of the DEA 

Office of Diversion Control. 

66The practitioner would also be required to be 

licensed and authorized to practice telemedicine in 

the state where the patient is located pursuant to 

the relevant State Telemedicine Registration. See 

proposed 21 CFR 1301.11(d). 

67Electronic Prescriptions for Controlled 

Substances, 75 FR 16236 (March 31, 2010). 

4. Special Registration for Telemedicine 

Actions 

a. Approval and Denial of Special 

Registration Applications 

Proposed amendments to 21 CFR 

1301.35 address the approval and denial 

criteria that would be considered on an 

application for Special Registration 

under 21 U.S.C. 831(h). The proposed 

amendment to § 1301.35(a) states that 

the Administrator shall issue a 

Certificate of Registration (DEA Form 

223) to a Special Registration applicant 

if: (1) the Special Registration applicant 

satisfies the eligibility requirements 

specified at proposed 21 CFR 

1301.11(c)(2) (Telemedicine Prescribing 

Registration), proposed 21 CFR 

1301.11(c)(3) (Advanced Telemedicine 

Prescribing Registration), proposed 21 

CFR 1301.11(c)(4) (Telemedicine 

Platform Registration) or proposed 21 

CFR 1301.11(d) (State Telemedicine 

Registration); and (2) after considering 

the public interest factors provided at 21 

U.S.C. 823(g)(1)(A)–(E), the 

Administrator has determined that the 

Special Registration will be consistent 

with the public interest. 

By evaluating Special Registration 

applicants on the eligibility 

requirements and considering the public 

interest factors under Section 823(g), 

DEA can ensure that only qualified 

practitioners, whether a clinician 

practitioner or a platform practitioner, 

who prioritize public safety and 

regulatory compliance are granted 

Special Registrations for Telemedicine. 

As is required for applications for other 

registrations (issued under 21 U.S.C. 

823 and 21 U.S.C. 958), proposed 21 

CFR 1301.35(a) requires the 

Administrator—if intending to deny an 

application—to issue an Order to Show 

Cause pursuant to 21 CFR 1301.37,65

and, if requested by the applicant, hold 

a hearing on the application pursuant to 

21 CFR 1301.31 for Special Registration 

Applications. 

Proposed 21 CFR 1301.35(d) would 

specify what information a Certificate of 

Registration (DEA Form 223) issued for 

a Special Registration shall contain: 

name; special registered location; 

Special Registration for Telemedicine 

(Telemedicine Prescribing Registration, 

Advanced Telemedicine Prescribing 

Registration, or Telemedicine Platform 

Registration), and State Telemedicine 

Registration(s); the activity authorized 

by the Special Registration, the 

Schedules and/or Administration 

Controlled Substances Code Number (as 

set forth in part 1308 of this chapter) of 

the controlled substances which the 

registrant is authorized to handle; the 

amount of fee paid (or exemption) for 

each registration, and the expiration 

date of each registration. Proposed 21 

CFR 1301.35(d) would also require a 

special registrant to maintain the 

Certificate of Registration at the special 

registered location in a readily 

retrievable manner and to permit 

inspection of the certificate by any 

official, agent or employee of the DEA 

or of any Federal, State, or local agency 

engaged in enforcement of laws relating 

to controlled substances. 

b. Suspension and Revocation of Special 

Registrations 

The proposed amendments to 21 CFR 

1301.36 outline when Special 

Registrations for Telemedicine 

(Telemedicine Prescribing Registration, 

Advanced Telemedicine Prescribing 

Registration, and Telemedicine Platform 

Registration), and State Telemedicine 

Registrations may be suspended or 

revoked. Proposed 21 CFR 1301.36(c) 

would provide that such Special 

Registrations for Telemedicine can be 

suspended or revoked based on the 

grounds specified in 21 U.S.C. 824(a), 

which are fundamentally designed to 

authorize DEA to intervene when 

registrants jeopardize the responsible 

handling of controlled substances. A 

Special Registration is contingent on the 

good standing of the registrant’s other 

DEA registrations; therefore, proposed 

21 CFR 1301.36(k) stipulates that the 

suspension or revocation of any 

registration under 21 U.S.C. 823 will 

trigger an automatic suspension or 

revocation of any registration issued 

under 21 U.S.C. 831. These automatic 

suspensions and revocations are 

designed to prevent registrants who 

have had one registration suspended or 

revoked due to non-compliance or risk 

to patient safety, from exploiting 

alternate registrations. 

B. Special Registration Prescriptions 

Issued by Clinician Special Registrants 

Under 21 CFR Part 1306 

Proposed 21 CFR 1306.41 through 

1306.47 provide heightened 

requirements for clinician special 

registrants when they issue special 

registration prescriptions. Along with 

these heightened special registration 

prescription requirements, clinician 

special registrants would remain 

obligated to comply with all 

prescription regulations required under 

their 21 U.S.C. 823(g) registration. The 

combination of heightened telemedicine 

standards and continued adherence to 

existing regulations ensures that the 

quality and integrity of medical practice 

are maintained, even in the evolving 

landscape of remote healthcare services. 

Generally, these proposed regulations 

address the manner in which 

prescriptions are issued by clinician 

special registrants, and certain elements 

required to be a part of special 

registration prescriptions. 

1. Manner of Issuance of Special 

Registration Prescriptions 

Prescription Origination within the 

United States. Proposed 21 CFR 1306.41 

would require that the clinician special 

registrant be physically present in the 

United States when conducting a 

telemedicine encounter and issuing a 

special registration prescription. 

Additionally, proposed 21 CFR 1306.41 

would require that the clinician special 

registrant hold the proper licensure and 

authorization within the state and 

territory where the practitioner is 

located when the telemedicine 

encounter takes place.66 For the 

purposes of this proposed rule, the 

‘‘United States’’ means the 50 states of 

the United States of America and the 

District of Columbia, the 

Commonwealth of Puerto Rico, Guam, 

the Commonwealth of the Northern 

Mariana Islands, the U.S. Virgin Islands, 

America Samoa, Wake Island, Midway 

Islands, Kingman Reef, Johnston Atoll, 

and any other trust territory or 

possession of the United States. This 

proposed requirement ensures that DEA 

retains jurisdictional control over 

special registration prescriptions and 

maintains clear boundaries on where 

these prescriptions are issued, ensuring 

compliance with U.S. laws and 

regulations. Restricting clinician special 

registrants from operating outside the 

U.S. also minimizes the risk associated 

with international boundaries, such as 

different regulatory frameworks and 

potential challenges in oversight and 

accountability. 

Electronic Prescribing for Controlled 

Substances (EPCS). Proposed 21 CFR 

1306.42 requires all special registration 

prescriptions be issued through EPCS.67

For the practice of telemedicine, in 

which physical practitioner-patient 

interactions do not exist, EPCS would 

be instrumental in securing the 

prescription process. It would establish 

a traceable and secure platform that 

reduces the risk of unauthorized access 


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6554 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

68EPCS Mandates: Ultimate Guide to 2023 

Deadlines √ RXNT (Available: https://

www.rxnt.com/epcs-mandates/). 

69Abouk R, Powell D. Can Electronic Prescribing 

Mandates Reduce Opioid-Related Overdoses? Econ 

Hum Biol. 2021 Aug;42:101000. doi: 10.1016/ 

j.ehb.2021.101000. Epub 2021 Apr 9. PMID: 

33865194; PMCID: PMC8222172 (Available: https:// 

www.ncbi.nlm.nih.gov/pmc/articles/PMC8222172/). 

70Telemedicine Listening Sessions, Dr. Shabana 

Khan (American Psychiatric Association and 

American Academy of Child and Adolescent 

Psychiatry), 36:21–37:1, 38:6–10, 41:20–42:6 (Sept. 

12, 2023); Dr. Helen Hughes (John Hopkins 

Medicine) 69:3–10 (Sept. 12, 2023); Jodi Sullivan 

(Investigations Medicare Drug Integrity Contractor), 

197:5–13, 197:24–198:21 (Sept. 12, 2023); and Dr. 

Jeffrey Chester, 256:22–257:10 (Sept. 12, 2023); 

Telemedicine Listening Sessions, Dr. Felicia Bailey, 

19:6–13 (Sept. 13, 2023); Dr. Connie Guille (Medical 

University of South Carolina), 52:11–20 (Sept. 13, 

2023); Christa Natoli (CTel), 151:15–152:3 (Sept. 13, 

2023); John Wells (Louisiana State University), 

160:4–8 (Sept. 13, 2023); Dan Golden (East Coast 

Telepsychiatry), 215:6–216:23 (Sept. 13, 2023); Dr. 

Shirley Reddoch, 235:14–18 (Sept. 13, 2023); Dr. 

Stephen Martin (Boulder Care), 128:24–129:10 

(Sept. 13, 2023); and Dr. Ujjal Ramtekkar (Quartet 

Health), 142:10–18 (Sept. 13, 2023). 71See Faustinella F. The Power of Observation in 

Clinical Medicine. Int J Med Educ. 2020 Nov 

30;11:250–251. doi: 10.5116/ijme.5fb9.1c9b. PMID: 

33254147; PMCID: PMC7883801 (Available: https:// 

www.ncbi.nlm.nih.gov/pmc/articles/PMC7883801/); 

and Bramstedt, Katrina, Ph.D., MA. The Use of 

Visual Arts as a Window to Diagnosing Medical 

Pathologies. AMA J Ethics. 2016;18(8):843–854. doi: 

10.1001/journalofethics.2016.18.8.imhl1–1608 

(Available: https://journalofethics.ama-assn.org/ 

article/use-visual-arts-window-diagnosing-medicalpathologies/2016-08). 

and forgeries. Moreover, the majority of 

states have enacted EPCS mandates to 

combat the opioid crisis by focusing on 

opioid access and enhanced oversight of 

possible misuse.68 According to one 

2021 study of New York’s e-prescribing 

mandate, the mandate reduced the rate 

of overdoses involving natural and 

semi-synthetic opioids by 22 percent.69

EPCS offers a robust and accountable 

system that prevents misuse and 

diversion of controlled substances, 

helping to maintain the integrity of 

prescribing among clinician special 

registrants. 

Nationwide Prescription Drug 

Monitoring Program (PDMP) Check. 

Proposed 21 CFR 1306.43 requires that 

clinician special registrants perform a 

check of relevant PDMPs. For a period 

of three (3) years from the date that a 

final rule becomes effective, before 

issuing any special registration 

prescription for controlled substance to 

a patient, the individual special 

registrant would be required to check 

the PDMPs for: (1) the state or territory 

where the patient is located; (2) state or 

territory where the clinician practitioner 

is located; and (3) any state or territory 

with PDMP reciprocity agreements with 

either the state or territory where the 

patient is located or the state or territory 

where the clinician practitioner is 

located. While the proposed regulation 

would require, at a minimum, that 

clinician special registrants check these 

three categories, DEA encourages 

clinician special registrants to check 

any other state PDMP that the registrant 

determines to be clinically appropriate. 

After three years, however, the 

individual special registrant would be 

required, before issuing any special 

registration prescription for controlled 

substances to a patient, to check the 

PDMPs of all 50 states of the United 

States and any other U.S. district or 

territory that maintains its own PDMP. 

This requirement for a broader, 

nationwide PDMP check would not 

begin until three (3) years after the final 

rule’s effective date, to allow registrants 

and industry sufficient time to comply 

with the new requirement. If, however, 

there is no mechanism to perform such 

a nationwide check after these three 

years, then individual special registrants 

would remain required to continue 

performing PDMPs checks of the states 

in the three categories described above, 

and individual special registrants would 

only be able to issue special registration 

prescriptions for Schedule II controlled 

substances to patients located within 

the same state as the individual special 

registrant, i.e., where there is an intrastate practitioner-patient relationship. 

The proposed nationwide PDMP check 

requirement is intended to ensure that 

clinician practitioners and pharmacists 

have full visibility of a patient’s 

controlled substance prescription 

history, not to proactively furnish DEA 

with access to this data. Accordingly, 

this rule does not propose that DEA 

would gain any new avenues, by means 

of this rule, to collect information from 

state PDMPs beyond what is otherwise 

authorized by federal and state laws. 

This delayed nationwide PDMP check 

requirement also reflects that the 

fragmented nature of PDMPs across 

states and territories has created 

challenges for healthcare providers in 

obtaining comprehensive patient data, 

particularly in cases involving 

telemedicine. In the context of 

telemedicine, the extension of medical 

services across state boundaries 

increases the complexity of controlling 

diversion of controlled substances. 

Telemedicine allows patients to consult 

clinician practitioners located in 

different states, creating a scenario 

where patients might seek multiple 

prescriptions from different clinician 

practitioners practicing in different 

regions, i.e. ‘‘doctor shop,’’ by 

exploiting the current fragmented nature 

of PDMPs across the states. Moreover, 

the absence of in-person interaction 

with telemedicine patients may limit 

the practitioner’s ability to gauge 

whether patients are being honest about 

their medical history, potentially 

enabling the concealment of pertinent 

information related to controlled 

substances. During the Telemedicine 

Listening Sessions, various speakers 

highlighted the challenges resulting 

from the fragmented nature of PDMPs 

across states and territories and called 

for enhanced interoperability of PDMPs 

nationwide; some speakers also 

advocated for a unified national or 

federal PDMP to address these concerns 

more effectively.70

To address these risks to public health 

and safety, it is imperative that clinician 

special registrants ultimately be 

required to perform this comprehensive 

PDMP check of all 50 states, and any 

other U.S. district or territory that 

maintains its own PDMP. This 

comprehensive nationwide PDMP check 

would provide the clinician special 

registrants a comprehensive view of the 

patient’s prescription history, helping to 

prevent over-prescribing and mitigating 

the risk of patients engaging in ‘‘doctor 

shopping’’ to obtain multiple controlled 

substance prescriptions across state 

lines. DEA acknowledges that it is 

currently unlikely that any one 

healthcare provider has access to all 

PDMPs nationwide. However, DEA also 

recognizes that current efforts to 

standardize, centralize, and 

interconnect PDMP data are making 

headway. These initiatives, aimed at 

creating a more unified and accessible 

system, offer a feasible future solution to 

bridge the gap and improve the 

accessibility of vital prescription 

information. 

Special Registration Prescriptions and 

Audio-Video Telecommunication 

Systems. Proposed 21 CFR 1306.44(a) 

mandates that a clinician special 

registrant utilize both audio and video 

components of an audio-video 

telecommunications system to prescribe 

under the Special Registration 

framework for every telemedicine 

encounter whether an initial visit or 

subsequent visit or follow-up. This 

requirement underscores the critical 

need to not only audibly, but visually, 

assess patients when prescribing 

controlled substances. Controlled 

substances, which often carry a 

substantial risk of misuse or diversion, 

require a more comprehensive 

evaluation. Visual observation of the 

patient is crucial for providers, because 

it communicates valuable information 

that cannot be obtained through other 

means and allows for more effective 

identity verification.71 By observing a 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6555 

72 Fact Sheet: End of the COVID–19 Public Health 

Emergency, Press Release, U.S. Dept. of Health and 

Human Services (HHS)(May 9, 2023), https://

www.hhs.gov/about/news/2023/05/09/fact-sheetend-of-the-covid-19-public-health-emergency.html. 

73Rethinking the Impact of Audio-Only Visits on 

Health Equity, RAND Corp. (Dec. 17, 2021),), 

https://www.rand.org/blog/2021/12/rethinking-theimpact-of-audio-only-visits-on-health.html. 

74Telemedicine Listening Sessions, Melanie 

Melville (Legacy Community Health), 96:1–16 

(Sept. 12, 2023); Bruce Bassi, M.D., 29:18–30:3 

(Sept. 13, 2023); Connie Guille (Medical University 

of South Carolina), M.D., 53:21–54:1 (Sept. 13, 

2023). 

75Telemedicine Listening Sessions, Dan Golden, 

218:15–219:6 (Sept. 13, 2023). 

76See Telemedicine Listening Sessions, Kevin 

Duane. 202:21–203:9 (Sept. 12, 2023); and Bruce 

Bassi, M.D., 31:12–20 (Sept. 13, 2023). 

77Connolly SL, Miller CJ, Gifford AL, Charness 

ME. Perceptions and Use of Telehealth Among 

Mental Health, Primary, and Specialty Care 

Clinicians During the COVID–19 Pandemic. JAMA 

Netw Open. 2022;5(6):e2216401. doi:10.1001/ 

jamanetworkopen.2022.16401. 

78 42 CFR 8.12(h)(2)(ii). 

79 DeLaCruz et al., Telemental Health for the 

Homeless Population: Lessons Learned when 

Leveraging Care, (Dec. 8, 2022) https://

www.ncbi.nlm.nih.gov/pmc/articles/PMC9734763/. 

80Provisional Drug Overdose Death Counts, 

National Center for Health Statistics, Centers for 

Disease Control and Prevention. https://

www.cdc.gov/nchs/nvss/vsrr/drug-overdosedata.htm. Updated March 3, 2024. Last accessed 

April 12, 2024. 

81 Dadiomov, et al., Buprenorphine and naloxone 

access in pharmacies within high overdose areas of 

Los Angeles during the COVID–19 pandemic, Harm 

Reduction Journal (June 29, 2022), https://

harmreductionjournal.biomedcentral.com/articles/ 

10.1186/s12954-022-00651-3. Last accessed April 

11, 2024. 

82Larochelle, et al., Medication for Opioid Use 

Disorder After Nonfatal Opioid Overdose and 

Association with Mortality, Annals of Internal 

Medicine, (August 07, 2018), https://

www.acpjournals.org/doi/10.7326/M17-3107. Last 

accessed April 11, 2024. 

patient’s physical appearance, 

demeanor, and body language, providers 

can gather important indications of 

misuse or diversion of controlled 

substances. Though DEA has permitted 

audio-only telemedicine on a temporary 

basis for patients during and 

immediately after the COVID–19 PHE, 

the current landscape calls for a 

reevaluation. The Department of Health 

and Human Services (HHS) declared an 

end to the Federal PHE for COVID–19 

under section 319 of the Public Health 

Service Act on May 11, 2023,72 and as 

pointed out by some researchers, the 

‘‘risk benefit calculation of audio-only 

visits has changed, and it is increasingly 

important to protect patients from 

potentially lower-quality audio-only 

visits,’’ especially when visual 

observations are critical.73 At the 

Telemedicine Listening Sessions, 

various speakers advocated for the use 

of audio-video telemedicine 

specifically.74 Expressing their concerns 

about the use of audio-only 

telemedicine, one speaker said, ‘‘we 

require video visits. On rare occasions 

we do the telephone. Just for the fact 

you can lay eyes on the people. They 

may tell you they’re perfectly fine, but 

they may have tears coming down their 

face. They may have physical problems. 

They may have meth marks. You know, 

things that people need to see. So 

video’s important.’’ 75

The utilization of audio-video 

telecommunication systems—as 

opposed to audio-only communication 

technology—not only offers advantages 

in helping prevent diversion, but it also 

allows the clinician special registrant to 

visually confirm the patient’s identity in 

real time. This would be achieved by 

comparing the patient to their existing 

photo identification on file, which will 

exist in the vast majority of cases given 

the requirements under proposed 21 

CFR 1304.04(i). This direct visual 

verification serves as a further safeguard 

against the diversion of controlled 

substances during telemedicine 

encounters.76

Schedule III–V Special Registration 

Prescriptions for Opioid Use Disorder. 

Proposed 21 CFR 1306.44(b) would 

allow clinician special registrants to 

issue special registration prescriptions 

for, and platform special registrants to 

dispense, Schedule III–V controlled 

substances approved by the FDA for the 

treatment of Opioid Use Disorder 

(‘‘OUD’’) through the use of an audioonly telecommunications system as 

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

provided that the treatment was 

initiated through the use of an audiovideo telecommunications system as 

defined in the proposed 1300.04 of this 

chapter. According to one survey of 866 

mental health (MH), primary care (PC), 

and specialty care (SC) clinicians in the 

Department of Veterans Affairs New 

England Healthcare System (VANEHS), 

less than one-third of the clinicians 

surveyed rated phone as equivalent to or 

higher in quality when treating new 

patients. However, the survey indicated 

that support for such audio-only 

telecommunications increased 

significantly when treating established 

patients. These results highlight the 

importance of visual assessments for 

new patients, while showing that audioonly telecommunications may be more 

acceptable or useful once a patient is 

established.77

Currently, the only Schedule III–V 

narcotic drug approved by the FDA for 

the treatment of OUD is 

buprenorphine.78 DEA’s proposed 

authorization for the use of audio-only 

telecommunications systems for the 

treatment of OUD is rooted in the 

unique nature of OUD treatment. The 

complex and long-term management of 

OUD often necessitates a continuum of 

care that might be best accommodated 

through flexibility in 

telecommunication methods. Expanding 

the circumstances under which 

clinician practitioners are authorized to 

prescribe buprenorphine via 

telemedicine encounters, including 

audio-only encounters, would increase 

access to treatment for those individuals 

with OUD who may not want to seek 

treatment, or are unable to seek 

treatment, due to various economic, 

geographical, sociological, and logistical 

reasons. 

Many OUD patients may lack the 

financial means to obtain in-person 

treatment traditionally or through 

audio-video telemedicine encounters. 

OUD patients who are unhoused, 

unemployed, or facing other challenges 

may find it prohibitive to afford devices 

capable of audio-video telemedicine 

encounters or consistent access to 

wireless internet and/or data plans 

adequate to support bandwidth 

demands of telemedicine encounters.79

The estimated number of deaths from 

opioid overdoses for the 12-month 

period ending in October 2023 were 

79,695, with a peak of 83,985 opioid 

overdose deaths for the 12-month period 

ending in May 2023.80 Access to 

buprenorphine decreases the risk of 

overdosing,81 and increasing access to 

buprenorphine after a drug overdose has 

also been associated with a reduced risk 

of death.82 This allowance 

acknowledges the specific challenges 

faced by OUD patients and the 

importance of ensuring consistent 

therapeutic relationships with limited 

interruptions. 

It also important to highlight that the 

Expansion of Buprenorphine Treatment 

via Telemedicine Encounter final rule 

(RIN 1117–AB78), jointly promulgated 

with HHS elsewhere in this issue of the 

Federal Register, allows a DEAregistered practitioner without a Special 

Registration to issue a prescription for a 

Schedule III–V controlled substance 

approved by the FDA for the treatment 

of OUD via audio-only or audio-video 

telemedicine for an initial consecutive 

six-month supply. Following the initial 

six-month supply, practitioners may 

prescribe the controlled substance by 

other forms of the practice of 

telemedicine authorized under the CSA 

(such as pursuant to a Special 


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83Telemedicine Listening Sessions, Daniel Reck 

(Matclinics), 104:3–9. (Sept. 12, 2023). 

84Telemedicine Listening Sessions, Jerome 

Cohan (Catalyst Health Solutions), 268:2–20. (Sept. 

12, 2023). 

85U.S. Dept. of Health and Human Services, 

Office of Inspector General, OEI–02–24–00130, Data 

in Brief: The Risk of Misuse and Diversion of 

Buprenorphine for Opioid Use Disorder in Medicare 

Part D Continues to Appear Low: 2022 (Nov. 2023) 

(Available: https://oig.hhs.gov/oei/reports/OEI-02- 

24-00130.pdf). 

86U.S. Drug Enforcement Administration, 

Prescription for Disaster: How Teens Abuse 

Medicine (Accessed: Dec. 13, 2023) (Available: 

https://www.dea.gov/sites/default/files/resourcecenter/Publications/DEA_Prescription-For-Disaster_

508ver.pdf). 

87 It should be noted, however, that the Special 

Registered Location associated with the Advanced 

Telemedicine Prescribing Registration would not 

have to be in the same state in which the patient 

was issued the Schedule II controlled substance. 

Registration) or after conducting an inperson medical evaluation. 

This proposed Special Registration 

NPRM would not preclude a clinician 

special registrant from utilizing the 

authority under the Expansion of 

Buprenorphine Treatment via 

Telemedicine Encounter final rule (RIN 

1117–AB78) for the prescription of 

buprenorphine for the treatment of 

OUD. However, after the six-month 

supply has been completed, a clinician 

special registrant would need to initiate 

further prescribing of the controlled 

substance through an audio-video 

telecommunications system. After this 

initial audio-video telemedicine 

encounter, the clinician special 

registrant may then use audio-only 

telecommunications systems to 

prescribe buprenorphine for the 

treatment of OUD to the patient for the 

duration of the practitioner-patient 

relationship. 

DEA’s proposed authorization of 

audio-only telemedicine follow-ups 

under the Special Registration 

framework does not or should not be 

taken to imply that buprenorphine 

cannot be or is not diverted. Some 

presenters spoke to these issues during 

the Telemedicine Listening Sessions. 

According to one presentation, there is 

a ‘‘robust illicit market for 

buprenorphine,’’ and anecdotal reports 

of patients are selling buprenorphine to 

fund abuse of other controlled 

substances.83 Another presenter said 

that drugs like suboxone and 

buprenorphine, prescribed to treat OUD, 

are used as a ‘‘currency’’ to purchase 

other drugs like methamphetamines, 

and that in his community, ‘‘if 

methamphetamine is involved, you can 

pretty much be assured the diversion of 

buprenorphine is involved.’’ 84

Such anecdotal information, however, 

must be considered in the context of the 

nation’s opioid crisis, as well as recent 

data showing a lower risk of diversion 

for buprenorphine relative to other 

controlled substances. In November 

2023, a report by the Office of the 

Inspector General of HHS found that 97 

percent of Part D enrollees received the 

recommended amounts or less of 

buprenorphine for OUD in 2022, 

suggesting that the risk of misuse or 

diversion of buprenorphine in Medicare 

Part D may be low.85 Considering this 

data and the additional proposed 

safeguards in this rule for special 

registration prescriptions, including the 

initiation of buprenorphine through 

audio-video telemedicine encounters, 

DEA believes that expanding access to 

buprenorphine through audio-only 

follow-ups outweighs the relatively 

lower risk of misuse and diversion of 

buprenorphine. 

Schedule II Controlled Substance 

Prescriptions. Proposed 21 CFR 1306.45 

requires that every special registration 

prescription for a Schedule II controlled 

substance be issued by a clinician 

special registrant that maintains the 

Advanced Telemedicine Prescribing 

Registration, who is issuing the 

prescription while the clinician special 

registrant is practicing within their 

given medical specialty. Proposed 21 

CFR 1306.45(a) imposes further 

conditions on clinician special 

registrants who are pediatricians or 

board-certified in pediatric care and 

requires the mandatory presence of the 

minor’s parent or guardian when the 

clinician special registrant prescribes a 

Schedule II controlled substance to the 

minor. This proposed provision is 

rooted in DEA’s commitment to 

safeguarding the well-being of minors, 

particularly given the substantial risks 

associated with Schedule II controlled 

substances, including opioids. 

This safeguard aligns with the broader 

intent of the Ryan Haight Act, which 

was enacted following the death of Ryan 

Haight, who tragically died after 

obtaining prescription opioids online 

without a valid prescription and 

without having ever been seen by the 

prescribing physician. Ryan Haight was 

only 17 years old when he purchased 

the opioids, and 18 years old when he 

died.86 The direct parental or guardian 

supervision would help to discourage 

any potential misuse or attempts to 

acquire a Schedule II controlled 

substance for non-medical reasons. 

While DEA acknowledges potential 

concerns of minors who may perceive 

this as an intrusion on their privacy, it 

is crucial to balance this consideration 

against the inherent risks associated 

with Schedule II controlled substances 

in particular. It should also be noted 

that this proposed requirement would 

not extend to cases where a pediatrician 

prescribes a Schedule III through V 

controlled substance under the Special 

Registration framework. 

Given the higher potential for abuse 

and dependence of Schedule II 

controlled substances, 21 CFR 1306.45 

proposes two additional requirements 

when issuing a special registration 

prescription for a Schedule II controlled 

substance; DEA anticipates imposing 

one or both of the proposed 

requirements based on the comments 

received by stakeholders. The first of the 

two proposed requirements, under 

proposed 21 CFR 1306.45(b), would 

require that the clinician special 

registrant be physically located in the 

same state as the patient when issuing 

a special registration prescription for a 

Schedule II controlled substance. Under 

this same-state limitation, when issuing 

a Schedule II special registration 

prescription, a clinician special 

registrant would not only have to have 

the Advanced Telemedicine Prescribing 

Registration, and a State Telemedicine 

Registration in the state in which the 

patient is located, but the clinician 

special registrant would also have to be 

physically located in the same state as 

the patient.87 Requiring the clinician 

special registrant to be in the same state 

as the patient helps mitigate the risks 

associated with the prescribing of 

Schedule II controlled substances across 

state lines. Geographical proximity 

enables more effective oversight by state 

regulatory agencies to ensure 

compliance with state laws governing 

the prescription of these high-risk 

medications and will make it more 

likely that the clinician special 

registrant can see the patient in-person 

should any medical or diversion 

concerns arise. 

The second of the two proposed 

requirements, under proposed 21 CFR 

1306.45(c), would require that the 

average number of special registration 

prescriptions for Schedule II controlled 

substances constitutes less than 50 

percent of the total number of Schedule 

II prescriptions issued by the clinician 

special registrant in their telemedicine 

and non-telemedicine practice in a 

calendar month. Limiting the proportion 

of Schedule II prescriptions issued 

through telemedicine would help to 

manage the risks associated with the 

prescribing of Schedule II controlled 

substances by ensuring that a significant 

portion of these prescriptions are issued 

following in-person medical 

evaluations, which can provide a more 

comprehensive assessment of the 


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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6557 

88https://www.fda.gov/drugs/developmentapproval-process-drugs/national-drug-codedatabase-background-information; https://

www.fda.gov/drugs/drug-approvals-and-databases/ 

national-drug-code-directory. 

89Proposed 21 CFR 1306.47(b) would not require 

that the Special Registrant provide the registration 

number associated with their conventional 

registration under 21 U.S.C. 823(g). 

patient’s medical history and condition 

than can be done remotely. 

State Laws Applicable to Special 

Registration Prescriptions. Proposed 21 

CFR 1306.46 would require special 

registrants, when issuing a special 

registration prescription, to comply with 

the laws and regulations of the state in 

which the special registrant is located 

during the telemedicine encounter 

resulting in the special registration 

prescription; the state in which the 

patient is located during the 

telemedicine encounter resulting in the 

special registration prescription; and 

any state or states in which the special 

registrant maintains a DEA registration 

to dispense controlled substances or a 

medical license, to the extent that the 

law or regulation applies to 

telemedicine encounters between 

practitioners and patients located in the 

states in which the special registrant 

and the patient are each located during 

the telemedicine encounter resulting in 

the special registration prescription. 

This provision would require that the 

practice of telemedicine be conducted 

in accordance with applicable state laws 

set forth in 21 U.S.C. 802(54). 

2. Additional Elements on a Special 

Registration Prescription 

A prescription for controlled 

substances, whether issued via 

telemedicine or not, must contain the 

elements specified in 21 CFR 

1306.05(a), which encompass the 

signature of the prescriber, issue date, 

patient’s full name and address, drug 

details (name, strength, dosage form, 

and quantity), directions for use, and 

the practitioner’s name, address, and 

registration number.88 Proposed 21 CFR 

1306.47 would require two additional 

elements for special registration 

prescriptions: (1) the Special 

Registration numbers of the clinician 

practitioner and, if a platform 

practitioner facilitated the prescription, 

the platform practitioner; and (2) State 

Telemedicine Registration numbers of 

the clinician practitioner and, if a 

platform practitioner facilitated the 

prescription, the platform practitioner 

(unless exempted from obtaining a State 

Telemedicine Registration under 

proposed 21 CFR 1301.11(d)).89

Proposed 21 CFR 1306.47(c) would add 

a corresponding liability provision for 

these new requirements, to track the 

current provision in 21 CFR 1306.05(f) 

that imposes a corresponding liability 

on a pharmacist who fills a prescription 

not prepared in the form prescribed in 

21 CFR 1306.05(a). 

The inclusion of the Special 

Registration numbers of the clinician 

practitioner and the platform 

practitioner (if a platform practitioner 

facilitated the prescription) would 

provide the pharmacist the information 

necessary to determine whether the 

clinician practitioner has the authority 

to prescribe a Schedule II controlled 

substance under the Special 

Registration framework, and that the 

platform practitioner (if a platform 

practitioner facilitated the prescription) 

has the authority to dispense a Schedule 

II controlled substance. The inclusion of 

State Telemedicine Registration 

numbers would provide pharmacists the 

information necessary to verify that 

patients are only being prescribed 

special registration prescriptions by 

special registrants authorized to practice 

in the specific state where the patient is 

located; registered pharmacists would 

be able to verify these registration 

numbers on DEA’s CSA Registration 

Validation Tool. 

Pharmacists occasionally encounter 

what they may perceive as ‘‘red flags’’ 

for certain telemedicine prescriptions, 

which can stem from the nature of 

telemedicine itself, where patients may 

receive prescriptions from prescribers 

located at distances far away (both 

inside and outside the state where the 

patient is located). The geographical 

distance can raise doubts about the 

legitimacy of the prescription and could 

lead pharmacists to question its validity 

and refuse to fill the prescription. By 

verifying the State Telemedicine 

Registration numbers, pharmacists 

would be provided a level of assurance 

that a special registration prescription is 

legitimate when it originates from a 

prescriber located a significant distance 

from the patient. For clinician special 

registrants exempted from obtaining 

State Telemedicine Registrations, 

proposed 21 CFR 1306.47(a) would 

require them to instead provide a 

notation on the prescription identifying 

the state in which the patient is located. 

C. Recordkeeping and Reporting Under 

21 CFR Part 1304 

Clinician special registrants would 

remain subject to their existing 

recordkeeping and reporting obligations 

under their 21 U.S.C. 823(g) 

registrations; however, they would also 

be subject to supplementary 

requirements within the Special 

Registration framework. Clinician 

special registrants would be required to 

establish and maintain photographic 

records for patient verification and 

maintain their special registration 

prescription records at their designated 

special registered location. Platform 

special registrants, on the other hand, 

would be required to maintain and 

update credential verification and 

documentation records. As to data 

reported to DEA, pharmacies dispensing 

special registration prescriptions would 

be required to report monthly 

aggregated special registration 

prescription data on Schedule II 

controlled substances and certain 

Schedule III–V controlled substances, 

and special registrants would be 

required to report annually aggregated 

information about their telemedicine 

practice, including the number of new 

patients they treat through telemedicine, 

and the total number of special 

registration prescriptions for Schedule II 

controlled substances, and certain 

Schedule III–V controlled substances, 

they dispensed for the preceding year. 

1. Patient Verification Photographic 

Record 

Proposed 21 CFR 1304.04(i) would 

generally require that a clinician special 

registrant, or a delegated employee or 

contractor under the direct supervision 

of the clinician special registrant, verify 

the identity of a patient seeking 

treatment via telemedicine by requiring 

that the patient present a state or federal 

government-issued photo identification 

card through the camera of the audiovideo telecommunications system. At 

the first telemedicine encounter, the 

clinician special registrant would also 

be required to capture a photographic 

record of the patient presenting their 

federal or state-issued photo 

identification card or other acceptable 

documents and use the photographic 

records to confirm the patient’s identity 

in subsequent telemedicine encounters. 

If for some reason the patient does not 

consent to their photo being captured, 

proposed 21 CFR 1304.04 would allow 

the clinician special registrant (or their 

delegated employee or contractor under 

their direct supervision) to accept a 

copy of the patient’s federal or state 

government-issued photo identification 

card or other forms of documentation 

provided by the patient. To ensure that 

patient privacy is protected, the patient 

verification photographic records would 

be securely stored in the patient’s 

medical record or chart, separate from 

the special registration prescription 

records/data reported to DEA under 

proposed 21 CFR 1304.40. 

Recognizing that not all persons may 

have a photo identification card, 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
6558 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

90Telemedicine Listening Sessions: Lori UscherPines (RAND Corporation), 131:15–19 (Sept. 12, 

2023); Bruce Bassi, M.D., 29:18–30:3 (Sept. 13, 

2023); Dr. Phillip Moore (Gaudenzia), 85:10–16, 

86:14–87:8 (Sept. 13, 2023); and Dan Golden (East 

Coast Telepsychiatry), 218:9–14 (Sept. 13, 2023). 

91Telemedicine Listening Sessions: Dr. Shabana 

Khan (American Psychiatric Association and 

American Academy of Child and Adolescent 

Psychiatry), 33:20–34:5, 43:9–19 (Sept. 12, 2023); 

Dr. Brian Clear (Bicycle Health), 77:13–22 (Sept. 12, 

2023); Telemedicine Listening Sessions: Lori 

Uscher-Pines (RAND Corporation), 131:15–19 (Sept. 

12, 2023); Bruce Bassi, M.D., 29:18–30:3 (Sept. 13, 

2023); Dr. Phillip Moore (Gaudenzia), 85:10–16, 

86:14–87:8 (Sept. 13, 2023); and Dan Golden (East 

Coast Telepsychiatry), 218:9–14 (Sept. 13, 2023). 

92See Telemedicine Listening Sessions, Bruce 

Bassi, M.D., 31:12–20 (Sept. 13, 2023). 

93Proposed 21 CFR 1300.04 would define a 

covered platform relationship to mean ‘‘the formal 

association between the online telemedicine 

platform, in its capacity as a platform practitioner, 

and the clinician practitioner it directly employs, 

contracts with, or is otherwise professionally 

affiliated with to introduce or facilitate connections 

between patients seeking remote medical 

consultations and the clinician practitioner, via an 

audio-video telecommunications system, for the 

diagnosis, treatment, and prescription of controlled 

substances.’’ 

94 DEA has identified 36 depressants that 

constitute a benzodiazepine Scheduled in 21 CFR 

1308.14(c) at the time of this publication. 

proposed 21 CFR 1304.04(i)(1) would 

allow a clinician special registrant, or a 

delegated employee or contractor under 

the direct supervision of the clinician 

special registrant, to verify the identity 

of the patient with other forms of 

documentation, and would require the 

clinician special registrant to maintain a 

record of how they verified the patient’s 

identity and what documents were used 

to verify the patient’s identity. For 

example, a clinician special registrant 

(or their delegated employee or 

contractor under their direct 

supervision) might verify patient 

identity by observing a patient’s pay 

stub and/or a bill with the patient’s 

home address, a letter provided by a 

shelter employee if the patient is 

unhoused, or a patient’s school 

identification card or report card if the 

patient is a minor. 

This proposed requirement would 

ensure that the patient’s identity is 

verified at each telemedicine encounter, 

reducing the risk of unauthorized 

individuals diverting controlled 

substances. Throughout the 

Telemedicine Listening Sessions, 

various presenters underscored the 

importance of implementing strong 

patient identification measures in the 

context of telemedicine.90 According to 

some physicians who presented during 

the Telemedicine Listening Sessions, 

identity verification of telemedicine 

patients is currently a typical practice 

and constitutes a component of good 

care.91 Furthermore, the photographic 

record provides a clear link between the 

patient’s identity and the telemedicine 

encounter, supporting accurate 

recordkeeping under the Special 

Registration framework.92

2. Special Registration Telemedicine 

Encounter Record 

For every telemedicine encounter 

resulting in a special registration 

prescription, proposed 21 CFR 

1304.04(j) would require that clinician 

special registrants maintain a record of 

the date and time of the telemedicine 

encounter, the address of the patient 

during the telemedicine encounter, and 

the home address of the patient. Like 

patient verification photographic 

records, the clinician special registrant 

would be required to maintain Special 

Registration telemedicine encounter 

records for a minimum of two (2) years 

from the date of the telemedicine 

encounter. The proposed Special 

Registration telemedicine encounter 

record provides an additional layer of 

verification for the telemedicine 

encounter, detailed documentation that 

can be referenced by the clinician 

special registrant in the future and helps 

ensure that the patient is located in a 

state in which the clinician special 

registrant is authorized to prescribe 

controlled substances under the 

proposed Special Registration 

framework. 

3. Credential Verification and ConductRelated Documentation 

Proposed 21 CFR 1304.04(k) would 

require platform special registrants to 

maintain records related to clinician 

special registrants with whom they 

enter and maintain a covered platform 

relationship, including: 93 (1) 

verification of the clinician special 

registrant credentials, including but not 

limited to records on education, 

training, board or specialty 

certifications, and their Special 

Registration number and State 

Telemedicine Registration number(s); 

(2) the employment contract and any 

other contract between the platform 

special registrant and the clinician 

special registrant; and (3) any 

disciplinary actions or sanctions, or 

documentation of complaints, disputes, 

or incidents involving the practice of 

telemedicine. The platform special 

registrant would be required to maintain 

and update the credential verification 

and conduct-related records for a 

minimum of every two (2) years, which 

should be readily available for 

inspection by DEA. 

This proposed requirement is 

intended to address DEA’s concerns 

regarding the adequacy of the screening 

of the prescribers utilizing the services 

of the covered online telemedicine 

platforms as discussed above. By 

mandating the verification and 

documentation of clinician registrants’ 

qualifications and credentials, these 

records should serve as evidence of 

thorough screening processes by the 

platform special registrants, helping to 

ensure that only qualified and vetted 

clinician practitioners are practicing 

telemedicine under the Special 

Registration framework and reducing 

the risk of improper remote prescribing 

of controlled substances. Furthermore, 

by requiring that platform special 

registrants maintain such records, they 

are compelled to assume responsibility 

for the conduct and prescribing 

practices of the clinician special 

registrants whose telemedicine 

prescribing is facilitated by their 

platform. 

4. Centralized Recordkeeping at the 

Special Registered Location 

Proposed 21 CFR 1304.04(l) mandates 

that records arising from telemedicine 

encounters under the Special 

Registration framework be kept at the 

special registered location. Given the 

nationwide reach of telemedicine— 

where a special registrant could serve 

patients in any state—it would pose an 

unreasonable administrative burden to 

require the special registrant to 

maintain records in every state where 

telemedicine patients are located. By 

consolidating these records, DEA 

investigations are more efficient, 

enhancing the detection of diversion 

patterns, which is vital for preventing 

the diversion and misuse of controlled 

substances. This approach enhances 

public safety while ensuring a practical 

burden for practitioners. Furthermore, 

this proposed regulation keeps pace 

with modern recordkeeping practices, as 

the majority of healthcare providers 

already maintain electronic records, 

which can be easily centralized and 

accessed when required. 

5. Pharmacy Reporting of Special 

Registration Prescription Data 

Proposed 21 CFR 1304.60 would 

require that a pharmacy report aggregate 

data, within the first seven (7) days of 

the start of every month, for the special 

registration prescriptions filled during 

the preceding month for each Schedule 

II controlled substance and certain 

Schedule III–V controlled substances, 

including Ketamine, Tramadol, and any 

depressants that constitute a 

benzodiazepine (including their salts, 

isomers, and salt of isomers).94 For each 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6559 

95National Drug Code Directory, U.S. Food & 

Drug Administration (FDA) (July 22,2022) (https:// 

www.fda.gov/drugs/drug-approvals-and-databases/ 

national-drug-code-directory). 

96Understanding the Opioid Overdose Epidemic, 

Centers for Disease Control and Prevention (CDC) 

(Aug. 8, 2023), https://www.cdc.gov/opioids/basics/ 

epidemic.html. 

97Telemedicine Listening Sessions, Robert Krayn 

(Talkiatry), 26:4–21 (Sept. 12, 2023); Dr. Shabana 

Khan (American Psychiatric Association and 

American Academy of Child and Adolescent 

Psychiatry), 37:2–11 (Sept. 12, 2023); Dr. Brian 

Clear (Bicycle Health), 79:8–13, 87:3–8 (Sept. 12, 

2023); Chris Adamec (Alliance for Connected Care), 

143–18–144:11, 146:5–8 (Sept. 12, 2023); Kevin 

Duane, PharmD, 207:3–9, 213:13–214:9 (Sept. 12, 

2023); Felicia Baily (Nurse Practitioner, Avaesen 

Healthcare), 17:25–18:21 (Sept. 13, 2023); and John 

Heaphy (New York Dept. of Health), 78:25–79:6 

(Sept. 13, 2023). 

98Telemedicine Listening Sessions, Dr. Brian 

Clear (Bicycle Health), 79:8–13 (Sept. 12, 2023). 

99 Drug Control: Actions Needed to Ensure 

Usefulness of Data on Suspicious Opioid Orders, 

U.S. Gen. Accounting Office, GAO–20–118, (Jan. 29, 

2020),), https://www.gao.gov/products/gao-20- 

118#summary_recommend. 

100Telemedicine Listening Sessions, Dr. Shabana 

Khan (American Psychiatric Association and 

American Academy of Child and Adolescent 

Psychiatry), 37:18–23 (Sept. 12, 2023); Dr. Brian 

Clear (Bicycle Health), 79:8–13 (Sept. 12, 2023); and 

Laura Jantos (Healthcare Technology and Digital 

Healthcare Management Consultant), 14:25–15:21 

(Sept. 13, 2023). 

101 Id. 

102Centers for Disease Control and Prevention 

(CDC). What is Polysubstance Use? (February 23, 

2022) (Available: https://www.cdc.gov/ 

stopoverdose/polysubstance-use/index.html). 

103 Jones JD, Mogali S, Comer SD. Polydrug abuse: 

a review of opioid and benzodiazepine combination 

use. Drug Alcohol Depend. 2012 Sep 1;125(1–2):8– 

18. doi: 10.1016/j.drugalcdep.2012.07.004. Epub 

2012 Aug 2. PMID: 22857878; PMCID: PMC3454351 

(Available: https://www.ncbi.nlm.nih.gov/pmc/ 

articles/PMC3454351/). 

104National Institute on Drug Abuse (NIDA). 

Benzodiazepines and Opioids. (November 7, 2022), 

Available: https://nida.nih.gov/research-topics/ 

opioids/benzodiazepines-opioids. 

105 Dasgupta N, Funk MJ, Proescholdbell S, 

Hirsch A, Ribisl KM, Marshall S. Cohort Study of 

the Impact of High-Dose Opioid Analgesics on 

Overdose Mortality. Pain Med. 2016 Jan;17(1):85– 

98. doi: 10.1111/pme.12907. Erratum in: Pain Med. 

2016 Apr;17(4):797–8. PMID: 26333030, https://

pubmed.ncbi.nlm.nih.gov/26333030/). 

of these controlled substances, the 

pharmacy would provide the following 

information, organized by the different 

State Telemedicine Registration 

numbers of the individual special 

registrants who prescribed the 

controlled substance, and organized by 

the National Drug Code (NDC) for each 

formulation of the controlled substance 

dispensed: the number of prescriptions 

filled, the volume of the controlled 

substance dispensed, and the number of 

patients prescribed the controlled 

substance. A NDC is a unique, 10-digit 

three-segment number that serves as a 

universal product identifier for human 

drugs, including controlled substances. 

It is used by drug establishments, such 

as manufacturers and distributors, to 

report all drugs made, prepared, 

propagated, compounded or processed 

for sale in the U.S. to the Food and Drug 

Administration (FDA).95 At this time, 

Schedule III–V controlled substances 

subject to this proposed requirement 

under 21 CFR 1304.60 are limited to 

those specifically identified. However, 

additional Schedule III–V controlled 

substances may be included in the 

future via regulation based on trends in 

diversion and misuse. 

Requiring timely collection and 

reporting of aggregate patientanonymized prescription data ensures 

that DEA has current information on the 

prescribing of controlled substances via 

telemedicine, vital for protecting public 

health and safety, especially amid the 

national opioid overdose epidemic. 

Following the COVID–19 PHE, the 

opioid overdose epidemic has only 

worsened. According to the Centers for 

Disease Control and Prevention (CDC), 

the ‘‘number of people who died from 

a drug overdose in 2021 was over six 

times the number in 1999. The number 

of drug overdose deaths increased more 

than 16% from 2020 to 2021. Over 75% 

of the nearly 107,000 drug overdose 

deaths in 2021 involved an opioid.’’ 96

While the opioid overdose epidemic 

has, in recent years, been largely fueled 

by illicitly manufactured fentanyl, a 

synthetic opioid, the diversion of 

prescribed opioids exacerbates the 

opioid crisis by increasing the overall 

opioid supply available on the illicit 

market. Proposed 21 CFR 1304.60 

would arm DEA with the data necessary 

to timely intervene in cases of diversion 

or other acts in violation of the law. 

Recognizing the importance of data to 

combat diversion, various stakeholders 

speaking at the Telemedicine Listening 

Sessions—many of whom were 

practitioners—advocated for DEA to 

collect prescription data to help identify 

potential exploitative practices.97 One 

physician said, ‘‘I urge DEA to design 

any new process to improve [its] ability 

to oversee and audit prescribing 

patterns and to intervene when 

exploitative practice is 

identified. . . .’’ 98

The aggregation of prescription data 

would also allow DEA to employ 

advanced data analytics to further 

combat diversion. With such data, for 

example, DEA could detect outliers, 

irregular prescription volumes, and 

abnormal geographic concentrations of 

controlled substances. As identified by 

the Government Accountability Office 

(GAO) in its 2020 recommendations to 

DEA, which encouraged the enhanced 

utilization of data analytics to identify 

problematic patterns and trends to 

combat the opioid epidemic, ‘‘dataanalytics activities can include a variety 

of techniques to prevent and detect 

diversion, including data matching and 

data mining. Data matching is the 

largescale comparison of records and 

files to detect errors or incorrect 

information. It can be used to verify 

information provided by recipients or 

detect unreported changes. Data mining 

is the use of automated computer 

algorithms to detect patterns, including 

those that are otherwise not obvious, 

correlations, or anomalies within large 

data sets indicative of potential 

diversion.’’ 99 At the Telemedicine 

Listening Sessions, similar 

recommendations to those of the GAO 

were echoed.100 Various stakeholders 

advocated for the leveraging of data 

analytics as a tool to be used by DEA to 

address bad actors or exploitative 

practices.101

Data analytics could help recognize 

patterns in how controlled substances 

are combined to provide DEA with 

critical information about emerging 

trends in polysubstance abuse.102

Recent examples highlight the dangers 

of such combinations, underscoring the 

need for proactive measures. 

Benzodiazepines, Schedule IV 

depressants, have been used to amplify 

the effect of opioids, especially when 

injected.103 The combination of opioids 

and benzodiazepines can have dire 

consequences, as their use together 

increases the risk of overdose as both 

drugs cause sedation and suppress 

breathing.104 According to one study, 

overdose death rates among patients 

taking both drugs was 10 times higher 

than among those only receiving 

opioids.105 By staying informed about 

emerging drug use trends, particularly 

polysubstance abuse, DEA can take 

proactive measures to prevent these 

trends from evolving into widespread 

problems. This information not only 

aids in prevention but could also guide 

DEA in strategically directing resources 

and investigative efforts to ensure the 

most effective responses to emerging 

challenges. 

Lastly, DEA could use the aggregated 

data to make more informed, evidencebased policy decisions. For instance, 

DEA could timely monitor controlled 

substance prescription patterns and 

demand indicators to make informed 

quota decisions to prevent or mitigate 

shortages and ensure a steady and 

reliable supply of controlled substances 

for legitimate medical purposes. The 

data could also be used to better 

retrospectively assess the impact of 

DEA’s policy positions and promulgated 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
6560 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

106See Administrative Conference of the United 

States (ACUS), Administrative Conference 

Recommendation 2021–2: Periodic Retrospective 

Review (June 17, 2021) (Available: https://

www.acus.gov/document/periodic-retrospectivereview). 

107Stevens, Morgan. Click Here for Adderall: 

Fixing Telehealth Advertising and Services to 

Prevent Stimulant Misuse, Center for Data 

Innovation (Dec. 5, 2022), https://

www2.datainnovation.org/2022-telehealthstimulant-abuse.pdf. 

regulations.106 For example, DEA could 

use the prescription data to evaluate: 

patient outcomes associated with 

special registration prescriptions; the 

impact of the proposed Special 

Registration regulations on patient 

access to controlled substances 

(especially in remote or rural areas); the 

efficacy of the proposed Special 

Registration regulations on preventing 

and detecting diversion associated with 

remote prescribing; and trends or 

changes to telemedicine prescription 

practices that might necessitate 

regulatory reforms. 

It should be emphasized that the 

prescription data reporting would be 

aggregated and patient-anonymized, and 

will not be shared with persons or 

entities outside of DEA. Like all data 

provided to, and handled by, DEA, the 

security and privacy of such data will be 

handled with the highest standards of 

security and privacy. All data 

transmitted to and stored by DEA is 

encrypted, including data transmitted 

between external systems and internal 

databases. Furthermore, all data 

transmitted from registrants to DEA is 

additionally protected by Department of 

Justice firewalls and network 

monitoring. Access to the data is limited 

to certain authorized persons, employed 

or contracted by DEA. External user 

access to applications receiving and 

providing data require a unique 

username and a strong, complex 

password, internal users of the data are 

vetted by DEA and its Diversion Control 

Division’s security and privacy 

processes, and access is restricted 

according to a need-to-know-basis. 

6. Annual Special Registrant Reporting 

of Special Registration Prescription Data 

Proposed 21 CFR 1304.61 would 

require that individual special 

registrants and platform special 

registrants report annual data on the 

total number of new patients in each 

state for which they issued at least one 

special registration prescription for a 

Schedule II controlled substance or 

certain Schedule III–V controlled 

substances, including Ketamine, 

Tramadol, and any depressant 

constituting a benzodiazepine; the total 

number of special registration 

prescriptions for Schedule II controlled 

substances issued by the special 

registrant, in aggregate and across all 

states; and the total number of special 

registration prescriptions for certain 

Schedule III–V controlled substances, 

including Ketamine, Tramadol, and any 

depressant constituting a 

benzodiazepines (including their salts, 

isomers, and salt of isomers), which 

were issued by the special registrant, in 

aggregate and across all states. 

This proposed reporting requirement 

would provide DEA with necessary data 

to proactively monitor for concerning 

trends that may signal the existence of 

digital pill mills exploiting the proposed 

special registration framework to 

provide patients with medically 

unnecessary controlled substances.107

Data on new patients and distribution of 

Schedule IIs and certain Schedule III–V 

controlled substances on an annual 

basis would allow DEA to assess 

prescribing behaviors of controlled 

substances, identify spikes and 

anomalies in prescription volume, and 

take timely action against suspicious 

activity. At this time, Schedule III–V 

controlled substances subject to this 

proposed requirement under 21 CFR 

1304.61 are limited to those specifically 

identified. However, additional 

Schedule III–V controlled substances 

may be included in the future via 

regulation based on trends in diversion 

and misuse. 

D. Regulatory Definitions Under 21 CFR 

part 1300 

This last section provides an overview 

of proposed regulatory definitions and 

revisions to 21 CFR part 1300. These 

proposed definitions are intended to 

provide clarity as to the authorities and 

obligations of special registrants under 

the registration requirements (21 CFR 

1301), prescription requirements (21 

CFR 1306), and the recordkeeping and 

reporting requirements (21 CFR 1304). 

The proposed amendments offer 

definitions for the different, relevant 

registrations under the Special 

Registration framework, including the: 

Telemedicine Prescribing Registration, 

Advanced Telemedicine Prescribing 

Registration, Telemedicine Platform 

Registration, State Telemedicine 

Registration, and special registered 

location. The core aspects of these 

proposed definitions have largely been 

addressed in the preceding sections, 

requiring minimal discussion of many 

of them here. 

That said, the proposed term and 

definition of a covered online 

telemedicine platform warrants further 

discussion. A covered online 

telemedicine platform means an entity 

that facilitates connections between 

patients and clinician practitioners, via 

an audio-video telecommunications 

system, for the diagnosis and treatment 

of patients that may result in the 

prescription of controlled substances, 

but is not a hospital, clinic, local inperson medical practice, or insurance 

provider, and meets one or more of the 

following criteria: 

(1) the entity explicitly promotes or 

advertises the prescribing of controlled 

substances through the platform; 

(2) the entity has financial interests, 

whether direct incentives or otherwise, 

tied to the volume or types of controlled 

substance prescriptions issued through 

the platform, including but not limited 

to, ownership interest in pharmacies 

used to fill patients’ prescriptions, or 

rebates from those pharmacies; 

(3) the entity exerts control or 

influence on clinical decision-making 

processes or prescribing related to 

controlled substances, including, but 

not limited to: prescribing guidelines or 

protocols for clinician practitioners 

employed or contracted by the platform; 

consideration of clinician practitioner 

prescribing rates in the entity’s hiring, 

retention, or compensation decisions; 

imposing explicit or de facto prescribing 

quotas; directing patients to preferred 

pharmacies; and/or 

(4) the entity has control or custody 

of the prescriptions or medical records 

of patients who are prescribed 

controlled substances through the 

platform. 

When any one of the four factors are 

present, it solidifies the platform’s role 

as an integral intermediary in the 

remote dispensing of controlled 

substances. The proposed definition and 

criteria are intended to provide a 

practical and clear framework for 

identifying when a DTC online 

telemedicine platform’s conduct 

qualifies them as a covered online 

telemedicine platform, mandating 

registration as a dispenser with DEA. As 

proposed, this definition is intended to 

limit the Special Registration 

requirements only to those DTC online 

telemedicine platforms that play a 

substantial and integral role as 

intermediaries in the remote dispensing 

of controlled substances. 

Under the first criterion, when an 

entity explicitly promotes or advertises 

the prescribing of controlled substances 

through the platform, it is directly 

influencing patient behavior and 

decision-making. This targeted 

promotion guides patients to seek 

medical consultations and prescriptions 

for controlled substances through the 

platform, effectively influencing the 


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108See 42 CFR 418.3. 

109Proposed 21 CFR 1300.04. The current 

regulatory definition, 21 CFR 1300.04, initially 

implemented the Ryan Haight Act’s statutory 

definition by repeating the statutory provision and 

requiring the use of a ‘‘telecommunications system 

referred to in section 1834(m) of the Social Security 

Act’’ [codified at 42 U.S.C. 1395m(m)]. 

demand and supply of this service. This 

active role in attracting and managing 

patient flow makes the platform more 

involved as an integral intermediary in 

the remote prescribing of controlled 

substances. Under the second criterion, 

when an entity has financial interests 

tied to the volume or types of controlled 

substances prescriptions issued through 

the platform, the platform’s role extends 

beyond mere facilitation—it becomes a 

key player that directly affects the flow 

and distribution of controlled 

substances. The financial ties ensure 

that the platform’s operations are 

closely linked to the outcome of 

prescription activities, making it an 

integral intermediary in the process of 

remote prescribing of controlled 

substances. 

Under the third criterion, when an 

entity exerts control or influence on 

clinical decision-making processes or 

prescribing related to controlled 

substances, including but not limited to 

prescribing guidelines or protocols for 

clinician practitioners employed or 

contracted by the platform, imposing 

explicit or de facto prescribing quotas, 

or directing patients to preferred 

pharmacies, it plays a direct and active 

role in the decision-making processes 

that affect patient care and the 

distribution of controlled substances. 

The platform becomes an essential link 

in the chain between the clinician 

practitioner and the patient, making it 

an integral intermediary in the process 

of remote prescribing of controlled 

substances. Under the fourth and last 

criterion, when an entity has control or 

custody of the prescriptions or medical 

records of patients who are prescribed 

controlled substances through the 

platform, it has significant control over 

sensitive and regulated information, 

actively involving the platform in the 

handling and processing of controlled 

substances. Moreover, control or 

custody of such information allows a 

platform to influence patient treatment 

plans, underscoring their position as an 

intermediary, and thus dispenser, in the 

process of remote prescribing of 

controlled substances. 

It is important to clarify that 

ownership and operation of the online 

or digital system or platform on which 

the virtual visit takes places are not 

mandatory criteria within the proposed 

definition of a covered online 

telemedicine platform. Similarly, an 

entity solely operating a platform or 

system that merely provides the 

technological service or conduit for a 

telemedicine encounter to occur, 

without the presence of one of the 

additional four factors, would not 

constitute a covered online telemedicine 

platform. As discussed above, the 

definition is also drafted to exclude 

entities that engage in conduct that 

could potentially fall under the 

definition’s criteria but are not the types 

of entities whose primary business 

operations rely on, or center around, 

telemedicine services. 

The definition of covered online 

telemedicine platform also explicitly 

excludes certain types of entities, 

including hospitals, clinics, insurance 

providers, and local in-person medical 

practices. Local in-person medical 

practice is, in turn, defined by this rule 

to be a medical practice where less than 

50 percent of the total prescriptions for 

controlled substances collectively 

issued by the practice’s physicians and 

mid-level practitioners are issued via 

telemedicine in any given calendar 

month, but is not a hospital, clinic, or 

insurance provider. The type of entities 

excluded from the definition of covered 

online telemedicine platform are entities 

that engage in conduct that could 

potentially fall under the definition’s 

criteria but are not the types of entities 

whose primary business operations rely 

on, or center around, telemedicine 

services. 

Determining whether an entity 

dispenses controlled substances and 

meets the criteria of a covered online 

telemedicine platform is a fact-specific 

inquiry. If there is any uncertainty 

regarding the entity’s role as a 

dispenser, particularly concerning its 

involvement in the practitioner-patient 

relationship, registering may be 

advisable to avert the risk of 

enforcement action based on potential 

unregistered, and thus illegal, 

dispensing of controlled substances. 

Turning elsewhere, DEA is 

incorporating CMS’s current definitions 

and standards for the terms hospice care 

and palliative care.108 DEA 

acknowledges that its core expertise and 

mission revolve around combating the 

diversion of controlled substances, and 

therefore is leveraging the medical 

expertise of CMS by adopting its 

healthcare standards as to these terms. 

Lastly, the rulemaking rule proposes to 

revise the DEA regulatory definition of 

‘‘practice of telemedicine’’ to mean 

practice in accordance with applicable 

federal and state laws by a practitioner 

(other than a pharmacist) who is at a 

remote location from the patient and 

communicates with the patient, or 

health care professional who is treating 

the patient, using a telecommunications 

system defined in 42 CFR 410.78(a)(3), 

which practice falls within a category 

specified in the definition.109

E. Request for Comments 

With respect to the proposed rule, 

DEA invites comments regarding the 

need for any clarifications or suggested 

modifications to the proposed 

regulations, which are consistent with 

the public health and safety. The 

public’s input and insights are 

instrumental in achieving the 

appropriate balance between expanding 

access to care and implementing the 

necessary safeguards to prevent 

diversion of controlled substances 

effectively. In particular, DEA seeks the 

public’s input on the newly introduced 

Special Registrations (Telemedicine 

Prescribing Registration, Advanced 

Telemedicine Prescribing Registration, 

and Telemedicine Platform 

Registration), and the State 

Telemedicine Registrations. Again, DEA 

recognizes the broad nature of the 

proposed requirements, and highly 

encourages the public to provide input 

on appropriate implementation 

timelines, or on-ramps for phased or 

gradual adoption, to help ensure a 

smoother transition when the final rule 

takes effect. Practitioners, pharmacies, 

and industry are encouraged to provide 

their input on the time necessary to 

operationalize the proposed 

requirements. 

Furthermore, DEA is considering the 

inclusion of a severability clause in the 

final rule. Under such a clause, if any 

specific provision of the rule is found to 

be invalid or unenforceable by a court, 

the remaining provisions would 

continue to be operative and 

enforceable. We encourage public 

comments on the inclusion of such a 

clause, as well as whether any particular 

provisions of the proposed rule are 

especially integral to its overall 

implementation. All public insight, 

including responsive data, as to the 

effectiveness or appropriateness of the 

proposed safeguards is also encouraged. 

However, the public is asked to refrain 

from commenting on provisions that are 

simply republished existing regulatory 

definitions. These are included to 

provide context to the newly proposed 

definitions and to reduce editorial 

resources required for publishing the 

proposed rule. 


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6562 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

Appendices: 

BILLING CODE 4410–09–P 


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110OMB Circular A–4. 

BILLING CODE 4410–09–C 

V. Regulatory Analyses 

Executive Orders 12866, 13563, and 

14094 (Regulatory Review) 

DEA has determined that this 

rulemaking is a ‘‘significant regulatory 

action’’ under section 3(f) of Executive 

Order (E.O.) 12866, Regulatory Planning 

and Review and is also a section 3(f)(1) 

significant action. Accordingly, this 

proposed rule has been submitted to the 

Office of Management and Budget 

(OMB) for review. This proposed rule 

has been drafted and reviewed in 

accordance with E.O. 12866, 

‘‘Regulatory Planning and Review,’’ 

section 1(b), Principles of Regulation; 

E.O. 13563, ‘‘Improving Regulation and 

Regulatory Review,’’ section 1(b), 

General Principles of Regulation; and 

E.O. 14094, ‘‘Modernizing Regulatory 

Review.’’ 

Due to many uncertainties, DEA made 

a range of estimates: a low estimate, a 

moderate (primary) estimate, and a high 

estimate. Based on the moderate 

(primary) estimate, DEA projects that 

this proposed rule will result in a total 

annualized cost of $16 million, a total 

annualized cost savings of $23 million, 

for a net annualized cost savings of $7 

million. The low estimate results in a 

total annualized cost of $0.60 million, a 

total annualized cost savings of $0.85 

million, for a net annualized cost 

savings of $0.25 million. The high 

estimate results in a total annualized 

cost of $86 million, a total annualized 

cost savings of $122 million, for a net 

annualized cost savings of $36 million. 

Additionally, the proposed rule is 

estimated to increase annualized 

transfers (registration fees) to the federal 

government by $0.90 million, $24 

million, and $128 million per year, for 

the low, moderate (primary), and high 

estimates, respectively. Fees paid to the 

federal government are considered 

transfer payments and not costs.110 The 

full analysis of cost savings, costs, 

transfers, and benefits is provided 

below. 


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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6565 

Overview 

I. Regulatory Alternatives Considered 

II. Patient Costs, Cost Savings, and Benefits 

a. Patient’s Cost of Time per Practitioner 

Visit 

b. Patient’s Cost of Travel per Practitioner 

Visit 

c. Total Number of Telemedicine Visits 

i. Total Number of Telemedicine Visits 

Under the Current Telemedicine Rate 

ii. Forecasted Total Numbers of 

Telemedicine Visits 

d. Total Patient Cost Savings 

e. Patient Benefit: Increased Access to Care 

III. Practitioner and Mid-Level Practitioners 

(‘‘MLP’’) Costs, Cost Savings, and 

Transfers 

A. Number of Conventional Registrations, 

Special Registrations, and State 

Telemedicine Registrations 

B. Practitioner and MLP Cost To Apply for 

Special Registration 

C. Practitioner and MLP Cost To Report to 

DEA 

D. Practitioner and MLP Cost To Check 

PDMP per Visit 

E. Practitioner and MLP Total Costs; Cost 

Savings 

F. Practitioner and MLP Transfers 

G. Summary of Practitioner Costs, Cost 

Savings, Benefits, and Transfers 

IV. Pharmacy Costs 

V. Healthcare System Costs and Cost Savings 

VI. State Costs 

VII. Diversion 

VIII. Summary of Economic Impact 

I. Regulatory Alternatives Considered 

DEA considered three alternatives, 

including the selected alternative: (1) 

finalizing the proposed March 2023 

General Telemedicine NPRM and 

Buprenorphine NPRM; (2) an alternative 

that would allow the prescribing of 

Schedules III–V controlled substances 

under a single Special Registration for 

Telemedicine pursuant to 21 U.S.C. 

802(54)(E) and 831(h); and (3) the 

selected alternative. 

First, DEA considered promulgating 

final rules based on the proposed March 

2023 General Telemedicine NPRM and 

Buprenorphine NPRM pursuant to 21 

U.S.C. 802(54)(G). The proposed 

General Telemedicine NPRM would 

have allowed for an initial prescription 

of non-narcotic Schedules III–V 

controlled substances for no more than 

a 30-day supply in instances where the 

patient has never had an in-person 

medical evaluation, and additional 

prescriptions beyond the initial 30-day 

prescription would require that the 

patient undergo an in-person medical 

evaluation. The proposed General 

Telemedicine NPRM generally would 

have required that a patient undergo an 

initial in-person medical evaluation 

prior to the prescription of Schedule II 

controlled substances, and Schedule III– 

V narcotic controlled substances (with 

the exception of buprenorphine for 

opioid use disorder (‘‘OUD’’) treatment), 

unless there was a qualifying referral. 

Generally, the Buprenorphine NPRM 

would have allowed practitioners to 

prescribe buprenorphine for the 

induction of OUD treatment for no more 

than a 30-day supply through audioonly telemedicine. To obtain an 

additional supply of buprenorphine 

however, the patient would have to 

undergo an in-person medical 

evaluation within 30 days of the 

induction of the OUD treatment. 

Ultimately, DEA determined that final 

rules of the proposed regulations would 

have been potentially too burdensome 

on practitioners and patients, leading to 

reduced access to care. 

The second alternative considered by 

DEA would have allowed 

practitioners—irrespective of their 

medical specialty or the patients they 

treat—to prescribe Schedule III–V 

controlled substances under a single 

Special Registration for Telemedicine 

pursuant to 21 U.S.C. 802(54)(E) and 

831(h). Under this alternative, 

practitioners would not be authorized to 

prescribe Schedule II controlled 

substances. While this alternative could 

have established a more streamlined 

Special Registration framework, it 

would not take into consideration the 

diverse legitimate needs that 

practitioners may have to prescribe 

other controlled substances through 

telemedicine based on their medical 

specialties or the patients they serve. 

Additionally, it does not consider the 

fact that certain practitioners possess 

the necessary qualifications to prescribe 

Schedule II controlled substances 

through telemedicine, despite the 

heightened risk of abuse associated with 

Schedule II controlled substances. 

Consequently, DEA opted against this 

alternative. 

Finally, DEA is proposing the selected 

alternative, which would not require an 

in-person medical evaluation such as 

required under the first alternative and 

would allow certain qualified 

practitioners who demonstrate a 

legitimate need to prescribe Schedule II 

controlled substances through 

telemedicine unlike the second 

alternative. The selected, proposed 

alternative would establish a Special 

Registration framework pursuant to 21 

U.S.C. 802(54)(E) and 21 U.S.C. 831(h), 

and authorize three types of Special 

Registrations: the (1) Telemedicine 

Prescribing Registration allowing 

qualified clinician practitioners to 

prescribe Schedule III–V controlled 

substances via telemedicine; the (2) 

Advanced Telemedicine Prescribing 

Registration, allowing qualified 

specialized clinician practitioners (e.g., 

psychiatrists, hospice care physicians) 

and board-certified mid-level 

practitioners to prescribe Schedule II–V 

controlled substances via telemedicine, 

and (3) the Telemedicine Platform 

Registration for covered online 

telemedicine platforms in their capacity 

as platform practitioners. 

Baseline. For our analysis of the 

economic impact of the selected 

alternative, the baseline for the selected 

alternative is the period before the 

temporary COVID–19 PHE exceptions to 

the Ryan Haight Act. During the 

baseline period, under 21 U.S.C. 829(e), 

the Ryan Haight Act has generally 

required an in-person medical 

evaluation prior to the prescription of 

controlled substances. 

Proposed Requirements. The Ryan 

Haight Act does, however, provide an 

exception to this in-person medical 

evaluation requirement, where the 

practitioner is ‘‘engaged in the practice 

of telemedicine.’’ The Ryan Haight Act 

generally provides seven (7) distinct 

categories of the practice of 

telemedicine in which a prescribing 

practitioner might be unable to satisfy 

the Ryan Haight Act’s in-person medical 

evaluation requirement, yet nonetheless 

may be able to prescribe a controlled 

substance for a legitimate medical 

purpose in the usual course of 

professional practice. The proposed 

requirements would allow a practitioner 

to obtain a Special Registration for 

Telemedicine, which is one of the seven 

categories of the practice of 

telemedicine as defined under the Ryan 

Haight Act. To engage in the practice of 

telemedicine under the proposed 

Special Registration framework, the 

practitioner must possess each of the 

following: 

• An existing conventional DEA 

registration under 21 U.S.C. 823(g); 

• One of the three types of Special 

Registration for Telemedicine 

authorizing the prescribing of controlled 

substances via telemedicine; and 

• A State Telemedicine Registration 

allowing the prescribing of controlled 

substances via telemedicine for each 

state in which a patient is located. 


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111Accordingly, in discussing such studies, DEA 

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

telemedicine. 

112Patel 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. 

113Rhyan 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). 

As Graphic 1 shows, these types of DEA 

registrations are interconnected for the 

purposes of prescribing controlled 

substances under the Special 

Registration framework. To issue a 

special registration prescription to a 

patient located in a particular state, the 

practitioner must first obtain a State 

Telemedicine Registration for that state. 

However, a State Telemedicine 

Registration can only be obtained if the 

practitioner already holds or is 

simultaneously applying for a Special 

Registration for Telemedicine. In turn, 

the Special Registration for 

Telemedicine requires that the 

practitioner have an existing 

conventional DEA registration under 21 

U.S.C. 823(g). The proposed rule has 

certain requirements for: 

1. The application process: such as 

reporting professional affiliations with 

employers (21 CFR 1301.13(k)(2)(i)–(ii)), 

medical specialty (as mentioned above) (21 

CFR 1301.13(k)(2)(iv)), that the practitioner 

will maintain anti-diversion policies (21 CFR 

1301.13(k)(2)(iii)); and the facts and 

circumstances that form the basis for a 

legitimate need for a Special Registration for 

Telemedicine (21 CFR 1301.13(k)(2)(v)). 

2. The prescription process: such as PDMP 

checks for the patient state, special registrant 

state, and any states with reciprocity 

agreement with either state (21 CFR 

1306.43(a), a comprehensive nationwide 

PDMP check for all 50 states and any U.S. 

districts and territories that maintain a 

PDMP, if possible, starting three years from 

the effective date of the final rule (21 CFR 

1306.43(b)), all prescriptions issued through 

EPCS (21 CFR 1306.42), telemedicine 

encounters being audio-visual with limited 

exception (21 CFR 1306.44), the inclusion of 

additional elements on special registration 

prescriptions (21 CFR 1306.47) and, for 

Schedule II controlled substances, 

prescriptions issued for care under an 

appropriate specialty and other safeguards 

(21 CFR 1306.45). 

3. Recordkeeping and reporting 

requirements: such as patient verification 

using photographic records (21 CFR 

1304.04(i)), Special Registration telemedicine 

encounter records (21 CFR 1304.04(j)), 

credential verifications of clinician special 

registrants (21 CFR 1304.04(k)), centralized 

recordkeeping at the special registered 

location (21 CFR 1304.04(l)), pharmacy 

reporting of telemedicine prescription data to 

DEA (21 CFR 1304.60) and special registrant 

reporting of the number of new telemedicine 

patients and prescription aggregated data to 

DEA (21 CFR 1304.61). 

The costs, cost savings, benefits, and 

transfers associated with the proposed 

rule were evaluated from the 

perspective of the following impacted 

parties: patients, practitioners 

(including mid-level practitioners), 

pharmacies, healthcare systems, states, 

and society at large. The high and low 

ranges of economic impact are based on 

two factors: the rate of telemedicine 

visits resulting from this proposed rule 

and the level of participation by 

registrants under the proposed rule. 

II. Patient Costs, Cost Savings, and 

Benefits 

The proposed rule would benefit 

patients by reducing transportation 

costs, travel time costs, and expanding 

access to medical care. The cost savings 

associated with the proposed rule 

predominantly stem from reductions in 

two costs: (1) the cost of time, and (2) 

the cost of transportation. 

A. Patient’s Cost of Time per 

Practitioner Visit 

To derive patients’ cost of time, DEA 

needed to assess two factors: the average 

length of time to travel and wait for a 

practitioner’s appointment, and the 

average opportunity cost (i.e., forgone 

wages) to travel and wait for a 

practitioner’s appointment. Simply put, 

(average length of the time) × 

(opportunity cost) = patient’s cost of 

time. To determine an appropriate 

average length of time, DEA consulted 

relevant medical articles. While the 

practice of telemedicine proposed in 

this rule is a subset of telehealth that 

focuses on clinical services by 

practitioners, broader telehealth 

research can inform our understanding 

of telemedicine and provide a greater 

array of research to use in our analysis. 

It is also common for research to 

indicate it relates to ‘‘telehealth,’’ even 

when it may be more appropriate to call 

it a ‘‘telemedicine’’ study.111

To determine the average length of 

time to be used in this analysis, DEA 

consulted various studies. A 2023 study 

focused on cancer (non-elderly) 

telehealth patients treated between 

April 1, 2020, and June 30, 2021. This 

study found that telehealth patients 

saved about 2.9 hours of round-trip 

driving time and 1.2 hours of in-clinic 

time per visit, including time spent with 

a practitioner.112 However, as this study 

focused on non-elderly cancer patients, 

it did not adequately represent the 

broader scope of telehealth patients 

considered in this analysis. In contrast, 

a 2019 study indicated that the average 

length of time (combining travel and 

waiting time) was 45 minutes (0.75 

hours) per visit.113 Given that 68.2 

percent of all current telehealth claims 

are related to mental health, not nonelderly cancer patients, DEA believes 

that the 45-minute average is more 


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114Fair Health, ‘‘Monthly Telehealth Regional 

Tracker.’’ https://www.fairhealth.org/fh-trackers/ 

telehealth. (accessed 8/4/2023 selecting Jan 2020, 

which had Jan 2019 data, and May 2023 using 

National Statistics data dropdown menu). 

115Bureau 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. 116Bureau of Labor Statistics, Employer Costs for 

Employee Compensation—June 2024, https://

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

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

117Akinlotan, 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). 

118 Internal Revenue Service. Standard Mileage 

Rates, Notice 2024–08, https://www.irs.gov/pub/irsdrop/n-24-08.pdf. (accessed 10/18/2024). 

relevant for this analysis.114 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.115 Additionally, BLS 

reports that average wages and salaries 

for civilians are 68.8 percent of total 

compensation. The 68.8 percent of total 

compensation equates to 45.3 percent 

(100 percent/68.8 percent—1) load on 

wages and salaries.116 The load of 45.3 

percent, or $10.47 (0.453 x $23.11), is 

added to the hourly rate to estimate the 

loaded hourly rates. As can be seen in 

Table 1, the loaded hourly wage for 

patients is $33.58 ($23.11 + $10.47). 

Therefore, the $33.58 loaded hourly 

wage represents the hourly average 

opportunity cost to travel and wait for 

a practitioner’s appointment. 

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 Cost of Travel per 

Practitioner Visit 

To determine the cost of travel to and 

from a practitioner’s appointment, DEA 

used data from the Southwest Rural 

Health Research Center in the Texas 

A&M School of Public Health, and 

mileage reimbursement rates from the 

U.S. Internal Revenue Service (IRS). 

According to a 2017 survey by the 

Southwest Rural Health Research 

Center, the average national round-trip 

travel distance for a doctor’s visit was 

9.9 miles, or 19.8 miles round-trip.117

The IRS travel reimbursement rate for 

businesses is 67 cents per mile.118

Therefore, the patient’s cost of travel to 

and from a practitioner’s appointment— 

and thus the travel cost savings 

achieved by telemedicine patients who 

could forego such a trip—equals $13.27 

(19.8 miles x $0.67 per mile), as can be 

seen in Table 3 below. 

TABLE 3—PATIENT TRAVEL COST SAVINGS PER TRIP

Cost savings 

Travel cost per 

mile 

($) 

Travel 

distance 

(miles) 

Per 

appointment 

cost 

($) 

Travel cost savings ...................................................................................................................... 0.67 19.8 13.27 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
6568 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

119Total Patient Cost Savings = (number of firsttime telemedicine visits resulting in prescriptions 

for controlled substances) * (patient cost savings). 120U.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. 

121 Id. 

122From the survey: ‘‘Due to uncertainty 

regarding the true number of out-of-scope 

physicians in the 2018 NAMCS, the weighted 

frequency estimates for 2018 should be treated with 

caution. However, proportional estimates were not 

found to be significantly different between the 2018 

NAMCS and 2019 NAMCS.’’ 

123The IQVIA Institute. The Use of Medicines in 

the U.S. 2023. May 02, 2023. https://

www.iqvia.com/insights/the-iqvia-institute/reportsand-publications/reports/the-use-of-medicines-inthe-us-2023 (accessed 4/23/2024) reports 4,437 

million for 2019 unadjusted, but 6,218 million 

adjusted. A DEA IQVIA query of chain store 

prescriptions for 2019 was 4,386,834,000 but would 

be higher if food stores and independent were 

included. Ultimately, the 3,476,239,000 number 

from the survey appears low. However, even the 

number DEA used could be considered low, but 

DEA has chosen to be conservative. 

124 Id. 

C. Total Number of Telemedicine Visits 

The proposed rule’s patient cost 

savings result from eliminating the need 

for an initial 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 the proposed rule, DEA needed to 

estimate the total number of first-time 

telemedicine visits resulting in 

prescriptions for controlled 

substances.119 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, DEA established the 

total annual practitioner visits using 

available data. Second, the total was 

further refined to those practitioner 

visits conducted via telemedicine. 

Third, the total was reduced to those 

that constituted first-time telemedicine 

visits. Fourth, DEA determined the 

proportion of the first-time telemedicine 

visits that would result in prescriptions. 

Fifth, it refined the total number of firsttime telemedicine visits resulting in 

prescriptions of controlled substances. 

And lastly, DEA considered the impact 

of proposed requirements and 

determined the total number of firsttime telemedicine visits resulting in 

prescriptions of controlled substances 

under the proposed rule. DEA 

performed this multi-step analysis to 

derive the low, moderate (primary), and 

high estimates of the number of firsttime telemedicine visits resulting in 

prescriptions for controlled substances, 

which resulted in low, moderate 

(primary), and high values for the total 

patient cost savings. 

i. Total Number of Telemedicine Visits 

Under the Current Telemedicine Rate 

Step 1: Total Annual Practitioner 

Visits. As described above, DEA initially 

established the total annual practitioner 

visits using available data. According to 

the Centers’ for Disease Control and 

Prevention (CDC) 2019 National 

Ambulatory Medical Care (NAMC) 

sample survey, it was estimated that 

there were a total of 1,036,484,000 

practitioner visits that year, although 

not all of these visits resulted in 

prescriptions, as can be seen in Table 

4.120 An analysis of this survey revealed 

that a total of 3,476,239,000 

prescriptions were issued during 

medical visits that year, as can be seen 

in Table 4.121 This means that for every 

one practitioner visit, there were 

approximately 3.35 prescriptions, 

calculated as a coefficient of roughly 

0.2982, which can be seen in Table 5. 

TABLE 4—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 

And 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 

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 5—ESTIMATE OF VISIT PER

PRESCRIPTION COEFFICIENT

NAMC prescriptions ........ 3,476,239,000 

Prescriptions per visits 

ratio ............................. 3.35 

Visit per prescription coefficient ........................ 0.2982 

To estimate the total number of 

practitioner’s visits, DEA did not use the 

NAMC survey because the survey 

results have been volatile year-to-year, 

and it only includes ‘‘nonfederal officebased patient care physicians, excluding 

anesthesiologists, radiologists, and 

pathologists.’’ 122 Instead, DEA used the 

derived coefficient in conjunction with 

IQVIA’s more comprehensive 2019 

prescription data to derive a more 

representative figure.123 In 2019, IQVIA 

reported 4,386,834,000 prescriptions.124

By multiplying this number by the 

coefficient 0.2982, DEA estimated that 

there were approximately 1,308,153,900 

practitioner visits, as can be seen in 

Table 6. 


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125Fair Health, ‘‘Monthly Telehealth Regional 

Tracker.’’ https://www.fairhealth.org/fh-trackers/ 

telehealth. (accessed 10/19/2024 selecting July 2024 

using National Statistics data dropdown menu). 

126Andino, 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%). 

127U.S. Department of Health and Human 

Services, Centers for Disease Control and 

Prevention, National Center for Health Statistics. 

(2019). National Ambulatory Medical Care Survey: 

2019 National Summary Tables. Retrieved from 

https://www.cdc.gov/nchs/data/ahcd/namcs_

summary/2019-namcs-web-tables-508.pdf. 

TABLE 6—ESTIMATE OF NUMBER OF

PRACTITIONER VISITS

Coefficient ....................... 0.2982 

IQVIA prescriptions ......... 4,386,834,000 

Visits—IQVIA prescriptions ............................. 1,308,153,900 

Step 2: Rate of Telemedicine. DEA 

then further refined the total number of 

practitioner visits to those conducted 

through telemedicine. According to the 

Fair Health Monthly Telehealth 

Regional Tracker, as of July 2024, 4.7 

percent of medical claims were 

conducted through telehealth.125 As can 

be seen in Table 7, DEA then used this 

percentage to refine the total 

1,308,153,900 practitioner visits to those 

likely to be conducted through 

telemedicine once a final rule is 

promulgated. Applying 4.7 percent, or 

the current telemedicine rate, to the 

1,308,153,900 total practitioner’s visits 

gives a total of 68,024,003 practitioner 

visits conducted via telemedicine, as 

can be seen in Table 7. 

TABLE 7—NUMBER OF TELEMEDICINE

VISITS

Total practitioner visits .... 1,308,153,900 

Telemedicine rate ........... 0.047 

Telemedicine visits ......... 68,024,003 

Step 3: First-Time Visits. 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 the proposed 

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 the proposed rule, shows 

that the vast majority of practitioner 

visits are for returning patients, and 

approximately 10 percent of those 

practitioner visits are new visits.126 This 

is in line with the CDC’s 2019 NAMC 

nonfederal 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.127 Taking 10 percent of 

68,024,003 practitioner visits conducted 

via telemedicine would provide a total 

of approximately 6,802,400 first-time, 

telemedicine practitioner visits, as can 

be seen in Table 8. 

TABLE 8—NUMBER OF FIRST-TIME

TELEMEDICINE VISITS

Telemedicine visits ......... 68,024,003 

First-time telemedicine 

visit rate ....................... 0.1 

First-time telemedicine 

visits ............................ 6,802,400 

Step 4: 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 (Table 4 above), DEA 

determined, as reflected in Table 4, 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 

6,802,400 first-time, telemedicine visits 

resulting in approximately a total of 

4,889,996 first-time telemedicine visits 

resulting in the issuance of 

prescriptions, as can be seen in Table 9. 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
6570 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

128 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). 

129According 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). 

130 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). 

131 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 9—ESTIMATE OF NUMBER OF FIRST-TIME TELEMEDICINE VISITS WITH PRESCRIPTIONS

First-time telemedicine visits ............................................................................................................................. .............................. 6,802,400 

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 ................................................................................................ .............................. 4,889,996 

* Rounded. 

Step 5: 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 2023.128 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.129 Applying 

this 16 percent to the total number of 

4,889,996 telemedicine visits resulting 

in the issuance of prescriptions, 

provides a value of approximately 

782,399 first-time telemedicine visits 

resulting in prescriptions for controlled 

substances, as can be seen in Table 10. 

TABLE 10—CURRENT ESTIMATE OF

NUMBER OF FIRST-TIME TELEMEDICINE VISITS RESULTING IN PRESCRIPTIONS OF CONTROLLED SUBSTANCES

First-time telemedicine visits 

with prescriptions .............. 4,889,995.73 

Controlled substance (CS) 

rate .................................... 0.16 

First-time telemedicine visits 

with CS prescriptions ........ 782,399 

Step 6: Effect of the Proposed Rule. 

Lastly, DEA determined the total 

number of first-time telemedicine visits 

resulting in prescriptions of controlled 

substances under the proposed rule. 

Under the proposed 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 inperson follow-up.130 A similar study by 

Epic Research on specialty visits 

provided that 85 percent of mental 

health and psychiatry telehealth visits 

did not have an in-person follow-up 

visit.131 Because this proposed rule is 

not limited to mental health, DEA 

applied the broader and lower 61 

percent to the 782,399 first-time 

telemedicine visits resulting in 

prescriptions of controlled substances. 

The multi-step analysis ultimately 

derived a current estimate of 477,264 

first-time telemedicine visits resulting in 

prescriptions of controlled substances 

under the proposed rule, as can be seen 

in Table 11. 

TABLE 11—CURRENT ESTIMATE OF NUMBER OF FIRST-TIME TELEMEDICINE VISITS RESULTING IN PRESCRIPTIONS OF

CONTROLLED SUBSTANCES UNDER THE PROPOSED RULE

NAMC visits ......................................................................... 1,036,484,000 ........................ ........................ ........................ ........................

NAMC prescriptions ............................................................ 3,476,239,000 ........................ ........................ ........................ ........................

Prescriptions per visits ratio ................................................ 3.35 ........................ ........................ ........................ ........................

Visit per prescription coefficient .......................................... 0.2982 0.2982 ........................ ........................ ........................

IQVIA prescriptions ............................................................. ........................ 4,386,834,000 ........................ ........................ ........................

Visits—IQVIA prescriptions ................................................. ........................ 1,308,153,900 1,308,153,900 ........................ ........................

Telemedicine rate ................................................................ ........................ ........................ 0.047 ........................ ........................

Telemedicine visits .............................................................. ........................ ........................ 68,024,003 68,024,003 ........................

First time telemedicine visit rate ......................................... ........................ ........................ ........................ 0.1 ........................

First-time telemedicine visits ............................................... ........................ ........................ ........................ 6,802,400 ........................

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 .................. ........................ ........................ ........................ 4,889,996 4,889,996 

Controlled substance (CS) rate ........................................... ........................ ........................ ........................ ........................ 0.16 

First-time telemedicine visits with CS prescriptions ............ ........................ ........................ ........................ ........................ 782,399 

First-time telemedicine visits that do not have an in-person follow up visit. ........................................................... ........................ ........................ ........................ ........................ 0.61 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6571 

132The usage rate of telemedicine is the percent 

of medical visits conducted via telemedicine. 133For instance, for those who want to 

understand the potential of an economy, recessions 

may distort Gross Domestic Product (GDP) data. To 

counter that distortion interested parties may think 

in terms of the GDP at full employment and think 

how that full employment GDP grows every year. 

For some background see Universities-National 

Bureau Committee for Economic Research. The 

Measurement and Behavior of Unemployment. 

1957. https://www.nber.org/system/files/chapters/ 

c2638/c2638.pdf (accessed 10/20/2024). 

134 Monthly Telehealth Regional Tracker, Fair 

Health, https://www.fairhealth.org/fh-trackers/ 

telehealth. (accessed 8/4/2023 selecting April 2020, 

which had April 2019 data, using National 

Statistics data dropdown menu); Bartelt K, Piff A, 

Allen S, Barkley E. Telehealth Utilization Higher 

Than Pre-Pandemic Levels, but Down from 

Pandemic Highs. Epic Research. https://

www.epicresearch.org/articles/telehealthutilization-higher-than-pre-pandemic-levels-butdown-from-pandemic-highs (accessed 10/19/2024), 

S&P Global. Telehealth finds mental health, 

provider niche as usage drops from pandemic peak. 

September 9, 2021. https://www.spglobal.com/ 

marketintelligence/en/news-insights/latest-newsheadlines/telehealth-finds-mental-health-providerniche-as-usage-drops-from-pandemic-peak66229670 (accessed 10/1/2024); The difference in 

the peak levels of demand could be due to Fair 

Health looking at claims that include filling 

prescription drugs and other non-visit related 

claims. However, Fair Health does look at a much 

larger volume of claims, possibly over 3 billion each 

year (https://www.fairhealth.org/data), than the 

Epic Research study, which only studied 475 

million claims throughout the entire study period. 

135 Monthly Telehealth Regional Tracker, Fair 

Health, https://www.fairhealth.org/fh-trackers/ 

telehealth. (accessed 10/19/2024 selecting July 2024 

using National Statistics data dropdown menu). 

136SteelFisher GK, McMurtry CL, Caporello H, 

Lubell KM, Koonin LM, Neri AJ, Ben-Porath EN, 

Mehrotra A, McGowan E, Espino LC, Barnett ML. 

Video Telemedicine Experiences In COVID–19 Were 

Positive, But Physicians and Patients Prefer InPerson Care for The Future. Health Aff (Millwood). 

April 2023. 

137The Associated Press. Walmart says it will 

close its 51 health centers and virtual care service. 

NPR. May 1, 2024. https://www.npr.org/2024/05/ 

01/1248397756/walmart-close-health-centersvirtual-care#:∼:text=the%20asset%27s%20value.- 

,Sponsor%20Message,vision%20centers%20in%20t

he%20U.S. (accessed 10/31/2024). 

138Ellimoottil C. Understanding the Case for 

Telehealth Payment Parity. Health Affairs. May 10, 

2021. https://www.healthaffairs.org/content/ 

forefront/understanding-case-telehealth-paymentparity (accessed 10/31/2024). 

139Trotter C. In 30 states, you cannot use 

telehealth with out-of-state doctors. Pacific Legal 

Foundation. December 13, 2023. https://

pacificlegal.org/30-states-telehealth-rules/ (accessed 

10/24/2024). 

TABLE 11—CURRENT ESTIMATE OF NUMBER OF FIRST-TIME TELEMEDICINE VISITS RESULTING IN PRESCRIPTIONS OF

CONTROLLED SUBSTANCES UNDER THE PROPOSED RULE—Continued 

First-time telemedicine visits under the proposed rule with 

CS prescriptions .............................................................. ........................ ........................ ........................ ........................ 477,264 

ii. Forecasted Total Number of 

Telemedicine Visits 

To project the future level of 

telemedicine visits, a forecast is 

required, utilizing the usage rate of 

telemedicine.132 A forecast has two 

critical elements: 

1. Baseline (or starting) value, and the 

2. Growth rate from that baseline 

value. 

A typical forecast relies on the 

existing value and the historic data to 

extrapolate an expected growth rate. 

However, this process becomes more 

complex with volatile historical data, as 

fluctuations make it challenging to 

determine a stable baseline and reliable 

growth trend.133 In the case of 

telemedicine, the past five years have 

seen significant volatility in usage rates, 

resulting in baseline level and growth 

rates that have been significantly 

distorted, with the rate both increasing 

and decreasing depending on the time 

interval, as can be seen in Table 12. 

Specifically, the rate of telemedicine 

usage surged from 0.2 percent in 2019 

to 13 percent in the April 2020 peak 

according to Fair Health’s analysis of 

medical claims and to 31.2 percent in 

the second quarter of 2020 based on an 

analysis of doctor visits by Epic 

Research. 134 However, this trend 

reversed in subsequent years, with rates 

gradually declining. By the third quarter 

of 2023, the telemedicine usage rate had 

dropped to 5.8%, and as of July 2024, 

it stood at 4.7 percent, based on data 

from Epic Research.135

TABLE 12—HISTORICAL TELEMEDICINE RATE

Year Month 

Fair health 

(claims) 

(%) 

YOY change 

(%) Quarter 

Epic research 

(doctor visits) 

(%) 

YOY change 

(%) 

2019 .................................... April .................................... 0.15 ........................ 2Q 0.2 ........................

2020 .................................... April .................................... 13.0 8566.7 2Q 31.2 15500.0 

2021 .................................... ............................................. ........................ ........................ 2Q 9.1 ¥70.8 

2022 .................................... ............................................. ........................ ........................ 2Q 7.1 ¥22.0 

2023 .................................... May ..................................... 5.4 ........................ 2Q 6.0 ¥15.5 

2024 .................................... May ..................................... 4.8 ¥11.1 ........................ ........................ ........................

2024 .................................... July ..................................... 4.7 ........................ ........................ ........................ ........................

Uncertainty and Factors that May 

Affect Future Telemedicine Usage. The 

future of telemedicine is difficult to 

predict. Patients may start to embrace 

telemedicine again, or they may 

continue to return to in-person visits as 

pandemic habits recede, especially 

given the lack of in-person exams and 

vital sign measurements in 

telehealth.136 This uncertainty is 

reflected in corporate behavior. In 

March 2023, Walmart announced plans 

to further expand its telehealth services 

by opening 28 additional health 

centers.137 However, less than a year 

later, in May 2024, the company 

reversed course, announcing the closure 

of all 51 of their health centers and its 

telehealth service as it no longer 

believed it a sustainable business 

model. 

Even if the rule proposed in this 

NPRM were finalized, it remains 

unclear how state-level regulations will 

evolve and impact the telemedicine 

market. While 43 states and the District 

of Columbia (DC) may require 

commercial insurers to cover telehealth 

services (coverage parity), only a 

handful of states mandate equal 

reimbursement rates for telehealth and 

in-person care (payment parity).138

Further, some states have rolled back 

telemedicine flexibilities introduced 

during the pandemic and reverted to 

pre-pandemic restrictions. As of 

December 2023, 30 states have banned 

or heavily restricted telehealth 

appointments with out-of-state 

doctors.139

Technology could also play a critical 

role in shaping the telemedicine market. 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
6572 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

140Serrano LP, Maita KC, Avila FR, TorresGuzman RA, Garcia JP, Eldaly AS, Haider CR, 

Felton CL, Paulson MR, Maniaci MJ, Forte AJ. 

Benefits and Challenges of Remote Patient 

Monitoring as Perceived by Health Care 

Practitioners: A Systematic Review. Perm J. Dec 

2023. 

141U.S. Government Accountability Office. 

Closing the Digital Divide for the Millions of 

Americans without Broadband. WatchBlog. 

February 01, 2023. https://www.gao.gov/blog/ 

closing-digital-divide-millions-americans-withoutbroadband#:∼:text=Closing%20the%

20digital%20divide%20is,and%20Information

%20Administration%20(NTIA)(accessed 10/31/ 

2024). 

142 Jain S. Projected Growth in Demand for 

Healthcare Services is Tepid. Trilliant Health: The 

Compass. 11/6/2022, https://www.trilliant

health.com/market-research/studies/projectedgrowth-in-demand-for-healthcare-services-is-tepid 

(accessed 10/24/2024). 

143Adjusting the recent decline in the rate of 

telemedicine of 11.1 percent by the 2.0 percent 

growth of overall doctor visits means telemedicine 

visits may have fallen 9.1%. The 19 percent was 

taken from Fortune Business Insight. Telemedicine 

Market Size, Share & Industry Analysis, By Type 

(Products and Services), By Modality (Store-andforward (Asynchronous), Real-time (Synchronous), 

and Others), By Application (Teleradiology, 

Telepathology, Teledermatology, Telecardiology, 

Telepsychiatry, and Others), By End-User 

(Healthcare Facilities, Homecare, and Others), and 

Regional Forecast, 2024–2032 https://www.fortune

businessinsights.com/industry-reports/ 

telemedicine-market-101067 (Accessed 10/20/24); 

For simplicity a single growth rate was assumed. 

However, an alternative measure could project the 

gradual slowing of the annual decline of ¥22 

percent, ¥15.5 percent, and ¥11.1 percent from 

Table 12. Just using the change in decline in latest 

data of 4.4 percent (15.5¥11.1) would give ¥6.7 

percent in year 1, ¥2.3 percent in year 2, 2.1 

percent in year 3, 6.5 percent in year 4, 10.9 percent 

in year 5, 15.3 percent in year 6, and 19.7 percent 

in year 7. This is probably more in line with the 

expected course of telemedicine but is still 

uncertain. 

144Fortune Business Insight. Telemedicine 

Market Size, Share & Industry Analysis, By Type 

(Products and Services), By Modality (Store-andforward (Asynchronous), Real-time (Synchronous), 

and Others), By Application (Teleradiology, 

Telepathology, Teledermatology, Telecardiology, 

Telepsychiatry, and Others), By End-User 

(Healthcare Facilities, Homecare, and Others), and 

Regional Forecast, 2024–2032 https://www.fortune

businessinsights.com/industry-reports/ 

telemedicine-market-101067 (Accessed 10/20/24). 

For example, technological advances 

could reduce the cost of remote patient 

monitoring devices, further driving the 

demand of telemedicine.140 On the 

other hand, some communities may still 

not be able to utilize telemedicine in 

their homes, because they continue to 

lack the broadband internet to support 

the technology either because such 

broadband service is unavailable or 

unaffordable.141 Ultimately, the 

telemedicine market has been shaped by 

a shifting landscape of factors, making 

it difficult to pinpoint any one baseline 

value or rate of growth with any 

certainty. 

Low, Moderate (Primary), and High 

Estimates. Given these uncertainties, 

DEA analyzed a range of possible 

baseline values and growth rates for 

telemedicine usage (i.e., rates of 

telemedicine) to demonstrate a range of 

possible outcomes. This approach 

allows for the derivation of a low, 

moderate, and high estimate of the total 

number of telemedicine visits over the 

next 10 years. 

• For the low estimate, DEA selected 

a baseline telemedicine usage rate of 0.2 

percent, reflecting the lower levels of 

use observed in 2019, prior to the 

COVID–19 pandemic. A growth rate of 

2 percent was chosen, corresponding to 

the projected growth rate of primary 

care between 2022 and 2026.142

• For the moderate (primary) 

estimate, DEA used a baseline 

telemedicine usage rate of 4.7 percent, 

mirroring the current rate of 

telemedicine. A growth rate of 4.95% 

was derived by taking the average of two 

different projections: a robust growth 

rate of 19 percent and a negative rate of 

–9.1 percent.143

• For the high estimate, DEA selected 

a baseline telemedicine usage rate of 13 

percent, reflecting the usage observed at 

the April 2020 peak by Fair Health’s 

more comprehensive claims data during 

the pandemic. A growth rate of 19 

percent was chosen based on estimates 

from one source, Fortune Business 

Insights, which projected that growth 

rate per year between 2024 and 2032.144

The scenarios provided are informed 

projections, based on factors that could 

influence telemedicine usage and 

growth. While these projections draw on 

available data and insights from 

healthcare, they are ultimately 

speculative. The scenarios are 

summarized in Table 13 below. 

TABLE 13—SUMMARY OF THE THREE SCENARIOS

Scenario 

Telemedicine 

Rate 

(%) 

Growth 

(%) Demand 

Low .................................................. 0.20 2 Telemedicine usage returns to pre-pandemic level with low growth, corresponding to demand for healthcare services. 

Moderate (Primary) .......................... 4.70 4.95 Telemedicine usage remains at current level with moderate growth. 

High .................................................. * 13 19 Telemedicine usage surges to the pandemic peak level and grows at 

high growth rate. 

As seen in Table 11, ‘‘telemedicine 

rate’’ of ‘‘0.047’’ (4.7 percent) is a key 

factor in estimating ‘‘first-time 

telemedicine visits under the proposed 

rule with [controlled substance] 

prescriptions’’ of 477,264. Varying the 

‘‘telemedicine rate’’ to 0.2 percent and 

13 percent would result in ‘‘first-time 

telemedicine visits under the proposed 

rule with [controlled substance] 

prescriptions’’ to 20,309 (477,264 × (0.2/ 

4.7)) and 1,320,092 (477,264 × (13/4.7)), 

respectively. DEA estimates the number 

of first-time telemedicine visits under 

the proposed rule with controlled 

substance prescriptions would reach 

these levels in the first year of 

implementation of this proposed rule. 

Table 14 below summarizes the firstyear numbers and growth rates of firsttime telemedicine visits under the 

proposed rule with controlled substance 

prescriptions for the low, moderate 

(primary), and high estimates. 

TABLE 14—‘‘YEAR 1’’ VISITS AND GROWTH RATES

Low Moderate 

(primary) High 

(Year 1) First-time telemedicine visits under the proposed rule with CS prescriptions .............. 20,309 477,264 1,320,092 

Annual Growth Rate .................................................................................................................... 2.00% 4.95% 19.00% 


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145Myrick K, Mahar M, DeFrances CJ. 

Telemedicine Use Among Physicians by Physician 

Specialty: United States, 2021. NCHS Data Brief, no 

493. February 2024. https://www.cdc.gov/nchs/ 

data/databriefs/db493.pdf. 

146 Monthly Telehealth Regional Tracker, Fair 

Health, https://www.fairhealth.org/fh-trackers/ 

telehealth. (accessed 8/4/2023 selecting Jan 2020, 

which had Jan 2019 data, and May 2023 using 

National Statistics data dropdown menu). 

147 Id. 

148Substance Abuse and Mental Health Services 

Administration, Rural Behavioral Health: 

Telehealth Challenges and Opportunities, at 4 

(2016), https://store.samhsa.gov/sites/default/files/ 

sma16-4989.pdf. 

Applying the growth rates to the ‘Year 

1’ patient visit figures, DEA generated a 

10-year forecast as shown in Table 15 

below. 

TABLE 15—NUMBER OF VISITS FORECAST

Year 

Low Moderate 

(primary) 

High 

Growth rate 

(%) Patient visits Growth rate 

(%) Patient visits 

Growth rate 

(%) Patient visits 

1 ............................................................... ........................ 20,309 ........................ 477,264 ........................ 1,320,092 

2 ............................................................... 2 20,715 4.95 500,889 19 1,570,909 

3 ............................................................... 2 21,129 4.95 525,683 19 1,869,382 

4 ............................................................... 2 21,552 4.95 551,704 19 2,224,565 

5 ............................................................... 2 21,983 4.95 579,013 19 2,647,232 

6 ............................................................... 2 22,423 4.95 607,674 19 3,150,206 

7 ............................................................... 2 22,871 4.95 637,754 19 3,748,745 

8 ............................................................... 2 23,328 4.95 669,323 19 4,461,007 

9 ............................................................... 2 23,795 4.95 702,454 19 5,308,598 

10 ............................................................. 2 24,271 4.95 737,225 19 6,317,232 

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 10-year 

forecast of patient cost savings for low, 

moderate (primary), and high scenarios 

as shown in Table 16 below. 

TABLE 16—PATIENT ANNUAL TOTAL COST SAVINGS

Year Low 

($) 

Moderate 

(primary) 

($) 

High 

($) 

1 ................................................................................................................................................... 781,084 18,355,573 50,770,738 

2 ................................................................................................................................................... 796,699 19,264,191 60,417,160 

3 ................................................................................................................................................... 812,621 20,217,768 71,896,432 

4 ................................................................................................................................................... 828,890 21,218,536 85,556,770 

5 ................................................................................................................................................... 845,466 22,268,840 101,812,543 

6 ................................................................................................................................................... 862,389 23,371,142 121,156,923 

7 ................................................................................................................................................... 879,619 24,528,019 144,176,733 

8 ................................................................................................................................................... 897,195 25,742,163 171,570,329 

9 ................................................................................................................................................... 915,156 27,016,381 204,168,679 

10 ................................................................................................................................................. 933,463 28,353,674 242,960,743 

Present Value * ............................................................................................................................ 7,657,624 205,278,372 1,096,535,599 

Annualized Cost * ......................................................................................................................... 852,497 22,852,928 122,073,501 

* Present value and annualized values are based on a two percent (2%) discount rate. 

E. Patient Benefit: Increased Access to 

Care 

DEA believes this proposed rule may 

improve patient access to care. 

However, DEA maintains that 

telemedicine is not as effective as inperson visits. According to a NCHS Data 

Brief from February 2024, only 4.0 

percent of primary care physicians, 6.3 

percent of surgical specialty physicians, 

and 6.0 percent of medical special 

physicians believe telemedicine is as 

effective as in-person visits.145

Telemedicine has emerged as a vital 

solution for enhancing healthcare 

accessibility, especially in the face of 

healthcare shortages. Notably, it extends 

its benefits to patients in remote and 

other underserved areas, including by 

providing access to specialized care. As 

of July 2024, telehealth utilization is 4.7 

percent of medical claims (Table 12), a 

significant leap from the 0.17 percent 

recorded in January 2019, before the 

COVID–19 pandemic, demonstrating its 

growing importance.146 Most notably, 

mental health claims using telehealth 

had risen from 39.6 percent to 68.2 

percent during this period, 

demonstrating that the utilization of 

telemedicine for mental healthcare 

experienced a significant surge during 

the pandemic.147

The importance of telemedicine 

becomes even more apparent when 

considering the acute shortage of mental 

health professionals. Over 75 percent of 

all U.S. counties are classified as having 

mental health shortage areas, with 50 

percent lacking any mental health 

professionals. Long-distance travel for 

treatment remains a major accessibility 

barrier for individuals in rural areas 

with limited transportation options.148

As of June 2023, there were 6,546 

designated ‘‘Mental Health—Health 

Professional Shortage Areas’’ covering a 

total population of 163,355,252 


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6574 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

148Substance Abuse and Mental Health Services 

Administration, Rural Behavioral Health: 

Telehealth Challenges and Opportunities, at 4 

(2016), https://store.samhsa.gov/sites/default/files/ 

sma16-4989.pdf. 

149Health Resources and Services 

Administration, Designated Health Professional 

Shortage Area Statistics, Third Quarter of Fiscal 

Year 2023 Designated HRSA Quarterly Summary 

(2023). 

150 KFF, ‘‘Primary Care Health Professional 

Shortage Areas (HPSAs),’’ September 30, 2022, 

https://www.kff.org/other/state-indicator/primarycare-health-professional-shortage-areas-hpsas/ 

?currentTimeframe=0&sortModel=

%7B%22colId%22:%22Location%22,%22sort%22:

%22asc%22%7D. (accessed 8/4/2023). 

151Fair Health ‘‘A Multilayered Analysis of 

Telehealth,’’ July 2019. 152 Id. 

154 DEA estimate based on registrations. 

155 Id. 

156Bureau 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. 

157 IBISWorld. Telehealth Services in the US— 

Number of Businesses. February 15, 2024. https:// 

www.ibisworld.com/industry-statistics/number-ofbusinesses/telehealth-services-united-states/ 

(accessed 4/20/2024). 

people.149 However, it is crucial to note 

that the healthcare shortage issue 

extends beyond mental health 

professionals. A September 2022 report 

revealed that 97.6 million Americans 

live in areas with a primary health 

professional shortage, highlighting a 

broad need for enhanced access to a 

range of specialties.150

The utilization of telehealth is more 

prevalent among urban Americans and 

Americans between the ages of 31 to 50 

with respect to non-hospital-based 

provider-to-patient telehealth claims, 

which is the largest category of 

telehealth.151 However, when 

examining discharge-related providerto-patient telehealth claims, rural 

Americans and those over age 50 are the 

most prevalent.152 DEA is not certain as 

to why these disparities exist, but they 

could suggest that limited access to 

routine and preventative care in rural 

areas and for older patients result in 

higher rates of hospitalizations, leading 

to more discharge-related provider-topatient telehealth claims. With greater 

access, rural Americans and older 

patients may increase their nonhospital-based provider-to-patient 

telemedicine. With the potential for a 

broader range of telemedicine practices 

enabled by the proposed Special 

Registration framework, qualified 

practitioners and MLPs could effectively 

reach a larger patient population, 

ultimately resulting in improved 

healthcare outcomes and reduced costs 

for patients across the nation. 

As discussed further below, 

healthcare systems may, instead of 

lowering costs, be able to provide 

increased care at a similar cost based on 

an evaluation of health care systems.153

While practitioners may be able to 

reduce travel to and from the office, this 

time saving is likely much less than 

patients’ since practitioners may still go 

to the office and may see many patients. 

However, this travel time savings may 

allow practitioners to become more 

available to patients, increasing access 

to care. While DEA is unable to quantify 

all the benefits to increased patient 

access to care, DEA believes it is not 

negligible. 

III. Practitioner and MLP Costs, Cost 

Savings, and Transfers 

The proposed rule would impact 

qualified practitioners (limited to 

physicians, mid-level practitioners, and 

covered online telemedicine platforms) 

by imposing registration costs, imposing 

recordkeeping costs, creating transfer 

payments, allowing for travel cost 

savings, and allowing for greater 

demand for their services. Costs of the 

proposed rule are specific to the cost of 

applying for the conventional 

registration (for covered online 

telemedicine platforms), Special 

Registration for Telemedicine, State 

Telemedicine Registration, and for 

PDMP checks due to the increased risk 

of diversion from more practitioners 

having the authority to prescribe 

Schedule II–V controlled substances. 

DEA estimates that there will be no 

additional infrastructure cost for 

patients or providers with the Special 

Registration for Telemedicine, as DEA 

has concluded that most patients and 

providers will already possess or have 

ready access to a telecommunications 

system meeting the requirements of the 

proposed rule. An analysis of all costs 

is detailed below. 

A. Number of Conventional 

Registrations, Special Registrations, and 

State Telemedicine Registrations 

When it comes to analyzing the costs, 

cost savings, benefits, and transfers of 

practitioners, DEA has to consider that 

qualified practitioners will need to 

apply for two new types of registrations, 

with covered online telemedicine 

platforms needing to first ensure that 

they have a conventional registration 

with DEA pursuant to 21 U.S.C. 823(g) 

in their capacity as a platform 

practitioner. As discussed above, 

practitioners will have to apply for a 

Special Registration (either the 

Telemedicine Prescribing Registration, 

the Advanced Telemedicine Prescribing 

Registration, or the Telemedicine 

Platform Registration), as well as State 

Telemedicine Registrations (either State 

Telemedicine Registration for Clinician 

Special Registrants or State 

Telemedicine Registration for Platform 

Special Registrants), an ancillary type of 

registration required for each state in 

which patients are located that will be 

treated by the practitioner. 

The number of conventional 

registrations under 21 U.S.C. 823(g) will 

be equal to the number of Telemedicine 

Platform Registrations, because one 

conventional registration is required to 

obtain a Telemedicine Platform 

Registration; currently, no online 

telemedicine platforms have a 

conventional registration. As a starting 

point to determine the number of 

conventional registrations, Special 

Registrations and State Telemedicine 

Registrations to be expected under the 

proposed rule, DEA first looked at 

current registrations held by 

practitioners. For the number of covered 

online telemedicine platforms, DEA 

used the number of telemedicine 

companies as a proxy. 

As of October 19, 2024, there were 

2,153,900 DEA registrants.154 Among 

them, 1,122,940 were physicians who 

fall under this proposed rule (medical 

doctors and doctors of osteopathy), 

403,748 were nurse practitioners 

(‘‘NPs’’), and 168,201 were physician 

assistants (‘‘PAs’’), as shown in Table 17 

below.155 These numbers exceed the 

actual employment figures in these 

fields. Specifically, there are 770,850 

physicians, 280,140 nurse practitioners, 

and 145,740 physician assistants 

according to BLS.156 This variation can 

be attributed to the fact that some 

registrants maintain registrations in 

multiple states or locations.157 The 

number of employed can serve as a 

proxy for primary registrations, i.e. the 

823(g) registration predominantly used 

by a practitioner, while the difference 

between these two sets of numbers 

(number of registrants and employment 

numbers) provides an estimate of nonprimary registrations. 


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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6575 

158 IBISWorld. Telehealth Services in the US— 

Number of Businesses. February 15, 2024. https:// 

www.ibisworld.com/industry-statistics/number-ofbusinesses/telehealth-services-united-states/ 

(accessed 4/20/2024). 

159Fair Health, ‘‘Monthly Telehealth Regional 

Tracker.’’ https://www.fairhealth.org/fh-trackers/ 

telehealth. (accessed 10/19/2024 selecting July 2024 

using National Statistics data dropdown menu). 

160Cipher DJ, Hooker RS, Guerra P. Prescribing 

trends by nurse practitioners and physician 

assistants in the United States. J Am Acad Nurse 

Pract. 2006 June. https://pubmed.ncbi.nlm.nih.gov/ 

16719848/. 161Wabe N, Thomas J, Sezgin G, Sheikh MK, 

Gault E, Georgiou A. Medication prescribing in faceto-face versus telehealth consultations during the 

COVID–19 pandemic in Australian general practice: 

a retrospective observational study. BJGP Open. 

2022 March, https://www.ncbi.nlm.nih.gov/pmc/ 

articles/PMC8958736/pdf/bjgpopen-6-0132.pdf. 162Employment was used because practitioner 

commonly have multiple conventional registrations 

to cover each practice location, but only need one 

special registration. 

163 IBISWorld. Telehealth Services in the US— 

Number of Businesses. Feb. 15, 2024. https://

www.ibisworld.com/industry-statistics/number-ofbusinesses/telehealth-services-united-states/ 

(accessed 4/20/2024). 

164 DEA manufacturers and distributors with the 

most registrations have ten, with the median being 

one. Assuming platforms have a similar 

distribution, but have a max of 50, it would imply 

a median of five. This is approximately 10 times the 

clinician practitioner rate of 0.42. 

TABLE 17—REGISTRATIONS BY OCCUPATION

Occupation Number of 

employed 

Number of 

registrants 

Registrations 

per employed 

Primary 

registrations 

Non-primary 

registrations 

Physicians ............................................................................ 770,850 1,122,940 1.46 770,850 352,090 

Nurse Practitioner ................................................................ 280,140 403,748 1.44 280,140 123,608 

Physician Assistant .............................................................. 145,740 168,201 1.15 145,740 22,461 

Total .............................................................................. 1,196,730 1,694,889 1.42 1,196,730 498,159 

* Non-Primary Registrations figures are the differences between the Number of Registrants and Number of Employed. 

DEA believes covered online 

telemedicine platforms are best 

represented by telemedicine companies. 

IBISWorld estimates that as of 2023 

there were 1,306 such companies in the 

United States.158

Current Telemedicine Rate Estimate 

of Number of Registrations. According 

to the Fair Health Monthly Telehealth 

Regional Tracker, as of July 2024, 4.7 

percent of medical claims were 

conducted through telehealth.159 There 

may be some variation in how 

Physicians, Nurse Practitioners, and 

Physician Assistants prescribe.160

Telemedicine prescribing also may not 

be at the exact same rate as in-person.161

However, given the uncertainty in the 

exact difference and for simplicity, DEA 

has assumed that each practitioner type 

prescribes at the same rate and uses 

telemedicine to prescribe at the same 

rate as in-person. DEA applied the 

‘telemedicine rates’ in Table 13 to the 

total number of employed physicians, 

nurse practitioners, and physician 

assistants to estimate the number of 

individual practitioner Special 

Registrations there will be under the 

proposed rule. Applying the 

‘telemedicine rates’ of 0.2 percent, 4.7 

percent, and 13 percent to the total 

number of physicians, nurse 

practitioners, and physician assistants 

of 1,196,730, the estimated number of 

individual telemedicine prescribing 

registrations are 2,393, 56,246, and 

155,575 for low, moderate (primary), 

and high estimates, respectively.162

Using the 2023 IBISWorld estimate of 

telemedicine companies of 1,306 

provides an estimate of 1,306 

Telemedicine Platform Registrations.163

The number of conventional 

registrations would then also be 1,306, 

in line with Telemedicine Platform 

Registrations. Applying the relationship 

between the low (0.2 percent), moderate 

(primary) (4.7 percent), and high (13 

percent) ‘‘telemedicine rates’’ to the 

moderate (primary) estimate of 1,306 

Telemedicine Platform Registrations 

from IBISWorld, results in a low 

estimate of 56 (1,306 × (0.2/4.7)) and a 

high estimate of 3,612 (1,306 × (13/4.7)). 

Assuming the rate of registrants 

obtaining DEA registrations are in line 

with the rate of those that will obtain 

clinician State Telemedicine 

Registrations, DEA used 0.2 percent, 4.7 

percent, and 13 percent of the total 

number of registrations to provide the 

low, moderate (primary), and high 

estimates of how many clinician State 

Telemedicine Registrations there will be 

under the proposed rule. Multiplying 

the total number of registrations of 

1,694,889 (from Table 17) by 0.2 

percent, 4.7 percent, and 13 percent, 

results in 3,390, 79,660, and 220,336 

clinician State Telemedicine 

Registrations for low, moderate 

(primary), and high estimates, 

respectively. Assuming a similar 

relationship holds for platforms, the 

number of platform State Telemedicine 

Registrations are estimated to be 42 

percent (from Table 17, 1.42 

registrations per employed minus 1) 

higher than the level of Telemedicine 

Platform Registrations. However, 

platforms are expected to be registered 

in more states than clinician 

practitioners. Based on a DEA analysis 

of the distributions of other national 

registrant types, a rate of 10 times the 

clinician practitioner rate was 

chosen.164 The number of platform State 

Telemedicine Registrations is then 

estimated to be 420% (42% × 10) higher 

than the level of Telemedicine Platform 

Registrations, or 291 (56 × 5.20), 6,791 

(1,306 × 5.20), and 18,782 (3,612 × 5.20) 

for low, moderate (primary), and high 

estimates respectively. DEA estimates 

the number of special registrations 

would reach these levels in the first year 

of implementation of this proposed rule. 

Table 18 below summarizes the firstyear numbers and growth rates of 

special registrations for the low, 

moderate (primary), and high estimates. 

TABLE 18—‘‘YEAR 1’’ SPECIAL REGISTRATIONS AND GROWTH RATES

Low Moderate 

(primary) High 

‘‘Telemedicine rate’’ ..................................................................................................................... 0.20% 4.70% 13.00% 

Year 1 Patient Visits .................................................................................................................... 20,309 477,264 1,320,092 

Year 1 Telemedicine Prescribing-Individual ................................................................................ 2,393 56,246 155,575 

Year 1 State Telemedicine-Individual .......................................................................................... 3,390 79,660 220,336 

Year 1 Conventional-Platform ..................................................................................................... 56 1,306 3,612 


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6576 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

TABLE 18—‘‘YEAR 1’’ SPECIAL REGISTRATIONS AND GROWTH RATES—Continued 

Low Moderate 

(primary) High 

Year 1 Telemedicine Platform ..................................................................................................... 56 1,306 3,612 

Year 1 State Telemedicine-Platform ........................................................................................... 291 6,791 18,782 

Year 1 Total Registrations ........................................................................................................... 6,186 145,309 401,917 

Annual Growth Rate .................................................................................................................... 2.00% 4.95% 19.00% 

Applying the growth rates to the ‘Year 

1’ registration figures, DEA generated 

10-year forecasts for the low, moderate 

(primary), and high estimates as shown 

in Tables 19, 20, and 21 below. 

TABLE 19—REGISTRATIONS FORECAST (LOW, 0.2 PERCENT ‘‘TELEMEDICINE RATE’’) 

Year Growth rate 

(%) 

Telemedicine 

prescribingindividual 

State 

telemedicineindividual 

Conventionalplatform Telemedicine 

platform 

State 

telemedicineplatform 

1 ............................................................... ........................ 2,393 3,390 56 56 291 

2 ............................................................... 2 2,441 3,458 57 57 297 

3 ............................................................... 2 2,490 3,527 58 58 303 

4 ............................................................... 2 2,540 3,598 59 59 309 

5 ............................................................... 2 2,591 3,670 60 60 315 

6 ............................................................... 2 2,643 3,743 61 61 321 

7 ............................................................... 2 2,696 3,818 62 62 327 

8 ............................................................... 2 2,750 3,894 63 63 334 

9 ............................................................... 2 2,805 3,972 64 64 341 

10 ............................................................. 2 2,861 4,051 65 65 348 

TABLE 20—REGISTRATIONS FORECAST (MODERATE (PRIMARY), 4.7 PERCENT ‘‘TELEMEDICINE RATE’’) 

Year 

Growth 

rate 

(%) 

Telemedicine 

prescribingindividual 

State 

telemedicineindividual 

Conventionalplatform Telemedicine 

platform 

State telemedicineplatform 

1 ............. ................................ 56,246 .................... 79,660 .................... 1,306 ...................... 1,306 ...................... 6,791 

2 ............. 4.95 ........................ 59,030 .................... 83,603 .................... 1,371 ...................... 1,371 ...................... 7,127 

3 ............. 4.95 ........................ 61,952 .................... 87,741 .................... 1,439 ...................... 1,439 ...................... 7,480 

4 ............. 4.95 ........................ 65,019 .................... 92,084 .................... 1,510 ...................... 1,510 ...................... 7,850 

5 ............. 4.95 ........................ 68,237 .................... 96,642 .................... 1,585 ...................... 1,585 ...................... 8,239 

6 ............. 4.95 ........................ 71,615 .................... 101,426 .................. 1,663 ...................... 1,663 ...................... 8,647 

7 ............. 4.95 ........................ 75,160 .................... 106,447 .................. 1,745 ...................... 1,745 ...................... 9,075 

8 ............. 4.95 ........................ 78,880 .................... 111,716 .................. 1,831 ...................... 1,831 ...................... 9,524 

9 ............. 4.95 ........................ 82,785 .................... 117,246 .................. 1,922 ...................... 1,922 ...................... 9,995 

10 ........... 4.95 ........................ 86,883 .................... 123,050 .................. 2,017 ...................... 2,017 ...................... 10,490 


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165Andino, 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). 166 Id. 167This estimate is based on the time required to 

complete the new DEA Form 224S and DEA Form 

224S–M, which will be used as the application for 

a Special Registration for Telemedicine and State 

Telemedicine Registration. 168Bureau 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). 169Bureau of Labor Statistics, Employer Costs for 

Employee Compensation –June 2024, https://

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

09102024.pdf. (accessed 10/18/2024). 

170This estimate is based on the time required to 

complete DEA Form 224A, which would be 

modified to also be used as the application for the 

Special Registration for Telemedicine and State 

Telemedicine Registration. 

TABLE 21—REGISTRATIONS FORECAST (HIGH, 13.0 PERCENT ‘‘TELEMEDICINE RATE’’) 

Year 

Growth 

rate 

(%) 

Telemedicine 

prescribingindividual 

State 

telemedicineindividual 

Conventionalplatform Telemedicine 

platform 

State telemedicineplatform 

1 ............. ................................ 155,575 .................. 220,336 .................. 3,612 ...................... 3,612 ...................... 18,782 

2 ............. 19 ........................... 185,134 .................. 262,200 .................. 4,298 ...................... 4,298 ...................... 22,351 

3 ............. 19 ........................... 220,309 .................. 312,018 .................. 5,115 ...................... 5,115 ...................... 26,598 

4 ............. 19 ........................... 262,168 .................. 371,301 .................. 6,087 ...................... 6,087 ...................... 31,652 

5 ............. 19 ........................... 311,980 .................. 441,848 .................. 7,244 ...................... 7,244 ...................... 37,666 

6 ............. 19 ........................... 371,256 .................. 525,799 .................. 8,620 ...................... 8,620 ...................... 44,823 

7 ............. 19 ........................... 441,795 .................. 625,701 .................. 10,258 .................... 10,258 .................... 53,339 

8 ............. 19 ........................... 525,736 .................. 744,584 .................. 12,207 .................... 12,207 .................... 63,473 

9 ............. 19 ........................... 625,626 .................. 886,055 .................. 14,526 .................... 14,526 .................... 75,533 

10 ........... 19 ........................... 744,495 .................. 1,054,405 ............... 17,286 .................... 17,286 .................... 89,884 

DEA also expects that State 

Telemedicine Registrations could 

potentially be much greater than this 

estimate given the fact that State 

Telemedicine Registrations will not 

require a physical location. However, 

based on an analysis done on Medicare 

beneficiaries using 2020 data, only 5 

percent of telemedicine takes place 

across state lines and most of this outof-state care was for established patient 

care.165 To the extent established 

patient care was a practitioner-patient 

relationship established following an inperson medical evaluation it would also 

not be considered telemedicine per the 

proposed rule. Further, out of state 

telehealth represented only 0.8 percent 

of all visits.166 It is unclear how willing 

practitioners will be to register in 

multiple states to handle a very limited 

number of their patients who need 

telemedicine across state lines, and 

which represents such a small share of 

their total patient load. However, DEA 

believes these numbers could grow 

substantially based on having 

permanent telemedicine flexibilities in 

place around which practitioners can 

restructure their practices without 

comparable worry of future removal or 

expiration. This would be in line with 

an increasing number of practitioners 

working for platforms that serve a much 

broader geographical region compared 

to a typical physician office. 

B. Practitioner and MLP Cost to Apply 

for Special Registration 

In order to estimate the time cost for 

applying for the conventional 

registration, Special Registration 

(Telemedicine Prescribing Registration 

and the Advanced Telemedicine 

Prescribing Registration, or the 

Telemedicine Platform Registration) and 

the State Telemedicine Registration 

(State Telemedicine for Individual 

Special Registrants or State 

Telemedicine for Platform Special 

Registrants), DEA used an estimate of 

the amount of time and the value of that 

time for a practitioner to apply for the 

registration. To calculate the labor cost 

of applying for either the conventional 

registration, Special Registration or the 

State Telemedicine Registration, DEA 

estimates that on average it will take ten 

minutes (0.17 hours) to complete the 

registration application.167 Should the 

application for a Special Registration or 

the State Telemedicine Registration be 

completed at the same time, the extra 

cost would be minimal. However, erring 

on the side of caution, DEA has 

assumed applications will be done 

separately and therefore has not made 

such a reduction. 

Typically, practitioners delegate the 

task of completing DEA registration 

applications to their medical office 

administration or secretarial staff, or 

they may opt to use a credentialing 

company. For this reason, DEA has used 

the BLS median hourly wages for 

Medical Secretaries and Administrative 

Assistants, occupational code 43–6013, 

of $19.54.168 Additionally, BLS reports 

that average wages and salaries for 

civilians are 69 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.169 The load of 45.3 

percent, or $8.85 (0.453 × $19.54), is 

added to the hourly rate to estimate the 

loaded hourly rates. As can be seen in 

Table 22, the loaded hourly wage for 

completing DEA registration 

applications is $28.39 ($19.54 + $8.85). 

To calculate the labor cost of applying 

for either the Special Registration or the 

State Telemedicine Registration, DEA 

estimates that on average it will take ten 

minutes (0.17 hours) for an applicant to 

apply for any of them.170 The estimated 

labor cost to complete the application is 

$4.83 ($28.39 × 0.17). These 

registrations are for three years, so the 

annualized labor cost of registration is 

$1.61 ($4.83/3). This calculation is 

shown in Table 22 below. 

TABLE 22—PER APPLICATION COST

Occupation 

Hourly 

wage 

($) 

Load for 

benefits 

($) 

Loaded 

hourly 

wage 

($) 

Application 

time 

(hours) 

Cost per 

application 

($) 

Annualized 

cost per 

application 

($) 

Medical Secretaries and Administrative Assistants .................. 19.54 8.85 28.39 0.17 4.83 1.61 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
6578 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

171Bachhuber 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. 

172Bureau 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). Employment figures for 

Physicians and Surgeons are 716,950 and 53,900, 

respectively, for a total of 770,850. Weighted 

average = $126.85 × (716,950/770,850) + $167.74 × 

(53,900/770,850) = $129.71. 

173The number of physician, physician assistant, 

and nurse practitioner registrants are 1,122,940, 

168,201, and 403,748, respectively, for a total of 

1,694,889. The weighted average is $3.20 × 

(1,122,940/1,694,889) + $1.54 × (168,201/1,694,889) 

+ $1.50 × (403,748/1,694,889) = $2.63. 

C. Practitioner and MLP Cost to Report 

to DEA 

The proposed rule requires special 

registrants to report to DEA, on an 

annual basis, the total number of new 

patients in each state treated under their 

Special Registration for Telemedicine, 

the total number of prescriptions for 

Schedule II controlled substances issued 

by the special registrant, and the total 

number of prescriptions for qualified 

Schedule III–V controlled substances 

issued by the special registrant for the 

preceding year. The special registrant 

would be required to electronically 

report this data through the DEA Office 

of Diversion Control’s secure network 

application. 

DEA believes the creation of this 

report by the registrant’s electronic 

prescription controlled substance 

(EPCS) system will be a minimal onetime expense. EPCS systems already are 

required by CFR 1311.120(b)(27)(i) to 

track controlled substance transactions. 

The new piece of data that will be 

needed for this to be fully automated is 

tracking which patients fall under the 

proposed rule’s telemedicine 

requirements. DEA believes this can be 

added to these existing systems during 

routine operation and maintenance and 

tracked with minimal cost and effort. 

DEA believes the annual running of 

this report and submitting electronically 

to DEA can be done in six minutes (0.10 

hours). Using the previously calculated 

loaded hourly wage for Medical 

Secretaries and Administrative 

Assistants of $28.39, the cost per report 

is $2.84 ($28.39 × 0.1), as can be seen 

in Table 23 below. 

TABLE 23—PER REPORT COST

Occupation Hourly wage 

($) 

Load for 

benefits 

($) 

Loaded 

hourly 

wage 

($) 

Reporting 

time 

(hours) 

Cost per 

report 

($) 

Medical Secretaries and Administrative Assistants ............. 19.54 8.85 28.39 0.10 2.84 

D. Practitioner and MLP Cost to Check 

PDMP per Visit 

The proposed rule immediately 

requires practitioners to complete a 

PDMP check of (1) the state/territory 

where the patient is located; (2) the 

state/territory where the practitioner is 

located; and (3) any state/territory with 

PDMP reciprocity agreements with 

either the state/territory where the 

patient is located or the state/territory 

where the practitioner is located. With 

a delayed effective date of three years, 

it requires a PDMP review of all 50 

states and any U.S. districts and 

territories that maintain a PDMP prior to 

issuing a telemedicine prescription 

under the Special Registration. While a 

single comprehensive system that can 

check all 50 states and any U.S. districts 

and territories that maintain a PDMP is 

not currently available, once that system 

is in place, DEA believes it will perform 

similarly to existing PDMP checks. 

Based on a 2018 study, it takes a 

practitioner 27 seconds to log in and 37 

seconds to retrieve a report once logged 

in.171 The total time it takes to retrieve 

a PDMP report is roughly a minute (27 

+ 37 = 64 seconds) or 0.017 of an hour 

(1/60). 

From BLS data, DEA used the 

weighted average of the mean hourly 

wages for Physicians (occupation code 

29–1210) and Surgeons (occupation 

code 29–1240) to represent the wages 

for all practitioners. For Physicians, the 

mean hourly wage and employment are 

$126.85 and 716,950, and for Surgeons, 

the mean hourly wage and employment 

are $167.74 and 53,900; the weighted 

average of the median hourly wages is 

$129.71.172 DEA also used the average 

of the median hourly wages for 

Physician Assistants (occupation code 

29–1071) of $62.51 and Nurse 

Practitioners (occupation code 29–1171) 

of $60.70 to represent the hourly wages 

of MLPs. As calculated earlier, a load of 

45.3 for benefits is added to these wages 

to calculate loaded wages. The loaded 

wages for physicians, PAs, and NPs are 

$188.47 ($129.71 × 1.453), $90.83 

($62.51 × 1.453), and $88.20 ($60.70 × 

1.453), respectively. 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 24—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 Assistants ............................................................ 62.51 28.32 90.83 0.017 1.54 

Nurse Practitioners .............................................................. 60.70 27.50 88.20 0.017 1.50 

For simplicity, DEA calculated a 

single cost of a PDMP check based on 

the weighted average of the three 

occupations. Using the ‘Number of 

Registrants’ from Table 17 to calculate 

weights, the weighted average of the 

PDMP check is $2.63.173

Recordkeeping and Infrastructure 

Costs. This proposed rule requires 

practitioners to maintain records 

relating to the Special Registration for 

Telemedicine. DEA believes that the 

recordkeeping requirements related to 

the Special Registration for 

Telemedicine will not impose major 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6579 

174 DrFirst. State Mandates Driving EPCS and 

PDMP Utilization. https://drfirst.com/resources/ 

regulatory-mandates/ (Accessed 11/2/2023). 

175New York State Department of Health. 

Frequently Asked Questions for the NYS PMP. June 

2017. https://www.health.ny.gov/professionals/ 

narcotic/prescription_monitoring/docs/pmp_

registry_faq.pdf (Accessed 11/2/2023), and Health 

Services Advisory Group. California’s Prescription 

Drug Monitoring Program (PDMP). https://

hsag.com/contentassets/d1483fc74ad34b

60b14cc1116e8cb14c/surscapdmpwork

flow2020508.pdf (Accessed 11/2/2023). 

176 Id. 

177 Delcher C, Pauly N, Moyo P. Advances in 

prescription drug monitoring program research: a 

literature synthesis (June 2018 to December 2019). 

Curr Opin Psychiatry. 2020 Jul. 

178 Data from Pdmpassist.org (Accessed 

September 2023). 

additional costs on registrants. 

Practitioners who prescribe using a 

Special Registration would face 

additional recordkeeping requirements; 

but, given that the photographic record, 

Special Registration telemedicine 

encounter record, credential verification 

and conduct-related recordkeeping, and 

centralized recordkeeping required by 

proposed 21 CFR 1304.04(i)–(l) is not 

extensive, DEA does not anticipate it 

imposes a major burden on registrants. 

DEA also examined the cost of 

technology for telemedicine, both 

capital investment and operational 

expenses, in order to operate under the 

proposed Special Registration for 

Telemedicine framework. DEA believes 

that these initial investments have 

already been made by the practitioners 

most likely to apply for the Special 

Registration for Telemedicine and that 

there will be no additional technology 

or infrastructure cost to these 

practitioners to use the Special 

Registration for Telemedicine. 

E. Practitioner and MLP Total Costs; 

Cost Savings 

Total Cost. As mentioned previously, 

the three types of costs to practitioners 

are: (1) registration time costs, (2) 

reporting time costs, and (3) PDMP 

check costs. In summary, these costs are 

listed in Table 25 below. 

TABLE 25—UNIT COST SUMMARY

Unit costs 

Registration application labor 

cost, annualized (applies 

to all registrations) ............ 1.61 

TABLE 25—UNIT COST SUMMARY— 

Continued 

Unit costs 

Reporting cost (applies to 

the number of primary 

special registration) ........... 2.84 

PDMP check cost (applies to 

all visit) .............................. 2.63 

Unlike patient travel time and cost 

savings, since the PDMP check is 

required for all visits and not just firsttime visits, there will not be a first-time 

visit adjustment. While PDMP checks 

will be required for all special 

registration prescriptions under this 

proposed rule, many practitioners 

already conduct PDMP checks. Due to a 

combination of the following factors, 

this would lower the additional burden 

imposed by this proposed rule: 

(1) 45 out of 50 states require PDMP 

checks in some form,174

(2) Some states, such as California and 

New York, require PDMP checks for 

Schedule II–IV drugs (excluding 

Schedule V),175

(3) Other states have requirements 

that focus on the initial visit and do not 

always require checks for all follow-up 

visits.176

(4) Compliance with existing state 

laws is not 100 percent and the 

proposed rule may have an impact, but 

there will also be instances of noncompliance.177

However, to be conservative, DEA 

applied the full cost of $2.63 to all 

telemedicine visits leading to a special 

registration prescription by backing out 

the 0.1 factor applied for first-time visits 

in Table 8, in other words by 

multiplying the number of first-time 

telemedicine visits (Table 11) under the 

proposed rule with controlled substance 

prescriptions by 10. The proposed rule 

intends for there to be a nationwide 

PDMP that would allow for one PDMP 

check per visit. However, until such a 

system is put in place, for the first three 

years practitioners will only be required 

under the proposed rule to check the 

state location of the patient, the state 

location of the practitioner, and all 

states with reciprocity agreements with 

either of those two states. This could 

increase the number of checks per visit 

to two for some practitioners. 

However, patients and practitioners 

may be in the same state. Also, based on 

a September 2023 analysis done by DEA 

of state PDMP participation, the average 

state, including the District of Columbia, 

only shares PDMP data with 30 other 

states.178 Both factors could 

substantially reduce the number of 

PDMP checks from two to something 

much closer to one. For simplicity, DEA 

will assume there will be only one 

PDMP check required, in line with its 

long-term expectation. 

Applying the annualized registration 

application labor cost of $1.61 to the 

number of registrations in Table 19, 20, 

and 21, the reporting cost of $2.84 to the 

number of primary (non-state) special 

registrations in Table 19, 20, and 21, 

and the PDMP check cost of $2.63 to all 

telemedicine visits that result in a 

controlled substances prescription (10 

times the number of first-time visits 

from Table 15), the 10-year cost forecast 

is shown in Tables 26, 27, and 28 below 

for the low, moderate (primary), and 

high estimates. 

TABLE 26—TOTAL PRACTITIONER AND MLP COST (LOW) 

Year 

Registration 

application 

labor cost 

($) 

Reporting 

cost 

($) 

PDMP 

check 

cost 

($) 

1 ................................................................................................................................................... 9,959 6,955 534,127 

2 ................................................................................................................................................... 10,159 7,094 544,805 

3 ................................................................................................................................................... 10,362 7,236 555,693 

4 ................................................................................................................................................... 10,570 7,381 566,818 

5 ................................................................................................................................................... 10,781 7,529 578,153 

6 ................................................................................................................................................... 10,995 7,679 589,725 

7 ................................................................................................................................................... 11,214 7,833 601,507 

8 ................................................................................................................................................... 11,437 7,989 613,526 

9 ................................................................................................................................................... 11,666 8,148 625,809 

10 ................................................................................................................................................. 11,898 8,310 638,327 

Present Value * ............................................................................................................................ 97,631 68,185 5,236,494 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
6580 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

179Snoswell CL, Taylor ML, Comans TA, Smith 

AC, Gray LC, Caffery LJ. Determining if Telehealth 

Can Reduce Health System Costs: Scoping Review. 

J Med internet Res. Oct 19, 2020. 

TABLE 26—TOTAL PRACTITIONER AND MLP COST (LOW)—Continued 

Year 

Registration 

application 

labor cost 

($) 

Reporting 

cost 

($) 

PDMP 

check 

cost 

($) 

Annualized Cost * ......................................................................................................................... 10,869 7,591 582,961 

* Present value and annualized values are based on a two percent (2%) discount rate. 

TABLE 27—TOTAL PRACTITIONER AND MLP COST (MODERATE—PRIMARY) 

Year 

Registration 

application 

labor cost 

($) 

Reporting 

cost 

($) 

PDMP 

check 

cost 

($) 

1 ................................................................................................................................................... 233,947 163,448 12,552,043 

2 ................................................................................................................................................... 245,528 171,539 13,173,381 

3 ................................................................................................................................................... 257,682 180,030 13,825,463 

4 ................................................................................................................................................... 270,437 188,942 14,509,815 

5 ................................................................................................................................................... 283,824 198,294 15,228,042 

6 ................................................................................................................................................... 297,873 208,110 15,981,826 

7 ................................................................................................................................................... 312,617 218,410 16,772,930 

8 ................................................................................................................................................... 328,089 229,219 17,603,195 

9 ................................................................................................................................................... 344,331 240,568 18,474,540 

10 ................................................................................................................................................. 361,376 252,476 19,389,018 

Present Value * ............................................................................................................................ 2,616,334 1,827,907 140,374,966 

Annualized Cost * ......................................................................................................................... 291,267 203,495 15,627,458 

* Present value and annualized values are based on a two percent (2%) discount rate. 

TABLE 28—TOTAL PRACTITIONER AND MLP COST (HIGH) 

Year 

Registration 

application 

labor cost 

($) 

Reporting 

cost 

($) 

PDMP 

check 

cost 

($) 

1 .................. 647,086 ..................................................... 452,091 ..................................................... 34,718,420 

2 .................. 770,032 ..................................................... 537,987 ..................................................... 41,314,907 

3 .................. 916,340 ..................................................... 640,204 ..................................................... 49,164,747 

4 .................. 1,090,445 .................................................. 761,844 ..................................................... 58,506,060 

5 .................. 1,297,631 .................................................. 906,596 ..................................................... 69,622,202 

6 .................. 1,544,180 .................................................. 1,078,848 .................................................. 82,850,418 

7 .................. 1,837,575 .................................................. 1,283,831 .................................................. 98,591,994 

8 .................. 2,186,713 .................................................. 1,527,758 .................................................. 117,324,484 

9 .................. 2,602,188 .................................................. 1,818,032 .................................................. 139,616,127 

10 ................ 3,096,603 .................................................. 2,163,458 .................................................. 166,143,202 

Present 

Value *.

13,975,657 ................................................ 9,764,161 .................................................. 749,841,038 

Annualized 

Cost *.

1,555,861 .................................................. 1,087,010 .................................................. 83,477,199 

* Present value and annualized values are based on a two percent (2%) discount rate. 

Cost Savings. The following sections 

summarize the expected cost savings 

related to the Special Registration for 

Telemedicine and State Telemedicine 

Registration that are realized by 

practitioners. As discussed in the 

healthcare system section, there may not 

be a cost savings on the healthcare 

system side based on an evaluation of 

health care systems.179 While 

practitioners may be able to reduce 

travel to and from the office, this time 

savings is likely much less than patients 

since practitioners may still go to the 

office and may see many patients, each 

of whom would be saving travel time. 

Practitioners may also become more 

available to patients which may offset 

any travel time and cost savings. In line 

with this, DEA believes the net cost 

savings for practitioners will be $0. 

F. Practitioner and MLP Transfers 

The following sections summarize the 

changes in transfers related to the 

expected new conventional 

registrations, the Special Registration 

for Telemedicine (Telemedicine 

Prescribing Registration, the Advanced 

Telemedicine Prescribing Registration 

and Telemedicine Platform Registration) 

and the State Telemedicine Registration 

(State Telemedicine for Individual 

Special Registrants and State 

Telemedicine for Platform Special 

Registrants) realized by practitioners. As 

discussed earlier, registrations fees paid 

to DEA are considered to be ‘‘transfers.’’ 

DEA proposes to set Special 

Registration fees to recover the cost of 

administering the registrations and 

operating the diversion control aspect of 

the proposed new business activities. 

Due to a myriad of unknowns, DEA is 

unable to calculate a cost that would 

need to be recovered. Therefore, DEA 

proposed to set the State Telemedicine 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6581 

180A non-VA practitioner would not be required 

to have a 21 U.S.C. 823(g)registration in his or her 

own State or a State Telemedicine Registration in 

the patient’s state if exempt from registration in all 

States under DEA regulations. See 21 U.S.C. 

831(h)(1)(B)(i), proposed 21 CFR 1301.61(b)(4). 

181This includes the annual cost of labor to 

process registrations ($17,107,968), the annual cost 

of labor to conduct liability pre-registration 

investigations ($2,955,422), and the annual cost to 

maintain the registration IT system ($8,866,672). 

Figures are rounded as shown. 182 Dividing the total annual cost of $28,930,063 

by the average number of new registrations and 

registration renewals processed annually from 

FY2018 to FY2020 of 645,734 yields a per 

registration cost of $45 (rounded). Practitioners pay 

this registration fee on a triennial basis. 

183Office of Management and Budget, Historical 

Tables, Table 10.1-Gross Domestic Product and 

Deflators Used in the Historical Tables: 1940–2029. 

https://www.whitehouse.gov/omb/budget/historicaltables. (https://www.whitehouse.gov/wp-content/ 

uploads/2024/03/hist10z1_fy2025.xlsx). (Accessed 

November 1, 2024). Using the ‘‘GDP (Chained) Price 

Index’’ of 1.05547 for 2020 and 1.2207 for 2023, $45 

in 2020 is adjusted for inflation to $52 ($45 × 

1.2207/1.0547) in 2023. $52 is rounded down to 

$50. 

for Individual Special Registration fee at 

$50 per three years and other Special 

Registration fees at the same rate as the 

‘‘dispensing or instructing’’ business 

activity (currently $888 per three years) 

as discussed further below. 21 CFR 

1301.13(e)(1)(iv). Other than the State 

Telemedicine for Individual Special 

Registration, the Special Registration 

provides authority to dispense 

controlled substances similar to the 

various registrants in the ‘‘dispensing or 

instructing’’ business activity. DEA’s 

cost of administering the registrations 

and operating the diversion control 

aspect of the Special Registrations are 

expected to be similar to that of 

registrations in the ‘‘dispensing or 

instructing’’ business activity. 

Conventional Registration Transfers. 

In order to prescribe controlled 

substances using a Special Registration 

for Telemedicine, practitioners generally 

must have three registrations. First, a 

practitioner must be registered under 21 

U.S.C. 823(g), i.e. a conventional 

registration, unless exempt from 

requirement of registration pursuant to 

21 CFR 1301.23(a). The fee for such 

823(g) registrations, ‘‘dispensing or 

instructing’’ business activity, is 

currently $888 for a three-year cycle 

($296/year) pursuant to 21 CFR 

1301.13(e)(1)(iv), unless exempt from 

fees pursuant to 21 CFR 1301.21(a). 

Unless subject to an exemption, all 

clinician practitioners that prescribe or 

dispense controlled substances must 

have this registration; therefore, the 

proposed rule does not impact this 

registration category or fee for clinician 

practitioners. 

Covered online telemedicine 

platforms must also be registered as 

practitioners. DEA applied the 

annualized registration fee calculated 

previously of $296 to the number of 

conventional registrations from Tables 

19, 20, and 21 to estimate the 

conventional registration transfers for 

low, moderate (primary), and high 

estimates. 

Special Registration Transfers. The 

proposed rule adds two new DEA 

registrations (and fees) that practitioners 

must obtain: a Special Registration for 

Telemedicine (either the Telemedicine 

Prescribing Registration, the Advanced 

Telemedicine Prescribing Registration 

and Telemedicine Platform 

Registration), and State Telemedicine 

Registrations (State Telemedicine for 

Individual Special Registrants and State 

Telemedicine for Platform Special 

Registrants).180

As discussed earlier, DEA proposes to 

set the fee for the individual Special 

Registration for Telemedicine 

(Telemedicine Prescribing Registration 

and Advanced Telemedicine Prescribing 

Registration) at the same fee as the 

‘‘dispensing or instructing’’ business 

activity, currently $888 per three years 

pursuant to 21 CFR 1301.13(e)(1)(iv). 

For now, DEA proposes to set the 

registration fee for Platform Special 

Registrants at the same fee as the 

Individual Special Registrants and 

registrants under the conventional 

registration of institutions, such as 

hospitals and clinics. As DEA gathers 

more data (such as pharmacy and 

practitioner reports included in this 

proposed rule) on the burden DEA 

incurs from Platform Special 

Registrants, this fee will be reevaluated. 

DEA applied the annualized registration 

fee of $296 to the number of Special 

Registrations, labeled ‘‘Telemedicine 

Prescribing-Individual’’ (which includes 

‘‘Telemedicine Prescribing’’ and 

‘‘Advanced Telemedicine Prescribing’’ 

registrations) and ‘‘Telemedicine 

Platform’’ in Tables 19, 20, and 21, to 

estimate the primary special registration 

transfers for low, moderate (primary), 

and high estimates. 

State Telemedicine Registration 

Transfers. It is also statutorily required 

that a practitioner ‘‘is registered under 

section 823(g) of this title in the State in 

which the patient will be located when 

receiving the telemedicine 

treatment. . . .’’ 21 U.S.C. 831(h)(B). 

Therefore, the proposed rule would 

create the State Telemedicine 

Registration (State Telemedicine for 

Individual Special Registrants and State 

Telemedicine for Platform Special 

Registrants) to satisfy this requirement. 

Registration fees generally cover two 

primary costs: (1) costs associated with 

processing and administering 

registrations, and (2) costs associated 

with general oversight and enforcement 

of controlled substance laws and 

regulations. The State Telemedicine for 

Individual Special Registration is an 

ancillary registration to the Special 

Registration and DEA proposes to set 

the fee at a level to recover DEA’s cost 

of processing and administering the 

registration only. Based on an internal 

DEA 2021 study, as can be seen in Table 

29 below, the total annual registration 

cost to DEA was $28,930,063.181 This 

equates to a registration cost per 

registration of $45.182

TABLE 29—HISTORICAL REGISTRATION COST OF CONVENTIONAL DEA REGISTRATION

Annual cost categories Annual cost 

($) 

Registrations 

per year 

Cost per 

registration 

($) 

Labor cost of processing registrations ........................................................................................ 17,107,968 645,734 26.49 

Labor cost of pre-registration investigations ............................................................................... 2,955,422 645,734 4.58 

Cost to maintain the registration IT system ................................................................................ 8,866,672 645,734 13.73 

Total ............................................................................................................................................. 28,930,062 ........................ 45 

Adjusting the $45 cost for inflation, 

from 2020 to current (end of 2023) 

dollars, the current estimated cost to 

process and administer a registration is 

$50.183 Since the registration is a threeyear registration, the annualized 

registration fee is $17 ($50/3). 

The cost to DEA of administering the 

platform State Telemedicine 

Registration (State Telemedicine for 

Platform Special Registrants) is not 


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6582 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

limited to the marginal registration cost. 

An individual doctor’s time is finite, 

whether they are serving patients in one 

state or multiple states. However, for a 

platform there can be a much greater 

number of patients, number of doctors, 

and risk of diversion given the broader 

scope of practice as compared to an 

individual practitioner. Each additional 

state creates access to a new pool of 

patients and a diversion risk that cannot 

be fully covered from the fees from the 

Telemedicine Platform Registration and 

other State Telemedicine for Platform 

Special Registrations. DEA is proposing 

a $888 platform State Telemedicine 

Registration (State Telemedicine for 

Platform Special Registrants) fee with 

an annual rate over three years of $296 

(888/3). Three-year registration fees and 

annualized fees are summarized in 

Table 30 below. 

TABLE 30—REGISTRATION FEES AND ANNUALIZED REGISTRATION FEES

Registration 

fee/transfer 

($) 

Annualized 

registration 

fee/transfer 

($) 

Telemedicine Prescribing-Individual ........................................................................................................................ 888 296 

State Telemedicine-Individual .................................................................................................................................. 50 17 

Conventional-Platform ............................................................................................................................................. 888 296 

Telemedicine Platform ............................................................................................................................................. 888 296 

State Telemedicine-Platform ................................................................................................................................... 888 296 

As with the Telemedicine Platform 

Registration fee, as DEA gathers more 

data (such as from pharmacy and 

practitioner reporting included in this 

proposed rule) on the burden from these 

registrants this fee may be adjusted in 

the future. DEA applied the annualized 

registration fee of $17 to the number of 

individual state registrations and the 

annualized registration fee of $296 to 

the number of platform state 

registrations from Tables 19, 20, and 21 

to estimate the state registration 

transfers for low, moderate (primary), 

and high estimates. 

Furthermore, based on review of 

DEA’s registration data, approximately 

8.2 percent of physicians, nurse 

practitioners, and physician assistants 

are exempt from paying registration 

fees. Therefore, a factor of 91.8 percent 

(100 ¥ 8.2) was applied to the number 

of individual primary and state 

registrations to estimate the number of 

fee-paying registrations. The annualized 

fees and fee-paying percentages for the 

various registrations are summarized in 

Table 31 below. 

TABLE 31—ANNUALIZED REGISTRATION FEES AND FEE-PAYING PERCENTAGES

Annualized 

registration 

fee/transfer 

($) 

Fee paying 

Telemedicine Prescribing-Individual ........................................................................................................................ 296 91.8% 

State Telemedicine-Individual .................................................................................................................................. 17 91.8% 

Conventional-Platform ............................................................................................................................................. 296 100% 

Telemedicine Platform ............................................................................................................................................. 296 100% 

State Telemedicine-Platform ................................................................................................................................... 296 100% 

Summary of Practitioner Transfers. 

Applying the annualized registration 

fees and fee-paying percentages (Table 

31) to the number of registrations from 

Table 19, 20, and 21, results in 

registration fee transfers as shown in 

Tables 32, 33, and 34 for low, moderate 

(primary), and high estimates 

respectively. 

TABLE 32—TOTAL TRANSFER PAYMENTS BY REGISTRATION

[Low] 

Year 

Telemedicine 

prescribingindividual 

($) 

State 

telemedicineindividual 

($) 

Conventionalplatform 

($) 

Telemedicine 

platform 

($) 

State 

telemedicineplatform 

($) 

1 ........................................................................................... 650,245 51,867 16,576 16,576 86,136

2 ........................................................................................... 663,288 52,907 16,872 16,872 87,912

3 ........................................................................................... 676,603 53,963 17,168 17,168 89,688

4 ........................................................................................... 690,189 55,049 17,464 17,464 91,464

5 ........................................................................................... 704,047 56,151 17,760 17,760 93,240

6 ........................................................................................... 718,177 57,268 18,056 18,056 95,016

7 ........................................................................................... 732,579 58,415 18,352 18,352 96,792

8 ........................................................................................... 747,252 59,578 18,648 18,648 98,864

9 ........................................................................................... 762,197 60,772 18,944 18,944 100,936 

10 ......................................................................................... 777,414 61,980 19,240 19,240 103,008

Present Value * .................................................................... 6,376,680 508,519 160,426 160,426 844,385 


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TABLE 32—TOTAL TRANSFER PAYMENTS BY REGISTRATION—Continued 

[Low] 

Year 

Telemedicine 

prescribingindividual 

($) 

State 

telemedicineindividual 

($) 

Conventionalplatform 

($) 

Telemedicine 

platform 

($) 

State 

telemedicineplatform 

($) 

Annualized Cost * ................................................................. 709,894 56,612 17,860 17,860 94,002 

* Present value and annualized values are based on a two percent (2%) discount rate. 

TABLE 33—TOTAL TRANSFER PAYMENTS BY REGISTRATION

[Moderate—Primary] 

Year 

Telemedicine 

prescribingindividual 

($) 

State 

TelemedicineIndividual 

($) 

Conventionalplatform 

($) 

Telemedicine 

platform 

($) 

State 

telemedicineplatform 

($) 

1 ........................................................................................... 15,283,613 1,218,798 386,576 386,576 2,010,136 

2 ........................................................................................... 16,040,104 1,279,126 405,816 405,816 2,109,592 

3 ........................................................................................... 16,834,093 1,342,437 425,944 425,944 2,214,080 

4 ........................................................................................... 17,667,483 1,408,885 446,960 446,960 2,323,600 

5 ........................................................................................... 18,541,904 1,478,623 469,160 469,160 2,438,744 

6 ........................................................................................... 19,459,801 1,551,818 492,248 492,248 2,559,512 

7 ........................................................................................... 20,423,076 1,628,639 516,520 516,520 2,686,200 

8 ........................................................................................... 21,433,905 1,709,255 541,976 541,976 2,819,104 

9 ........................................................................................... 22,495,002 1,793,864 568,912 568,912 2,958,520 

10 ......................................................................................... 23,608,544 1,882,665 597,032 597,032 3,105,040 

Present Value * .................................................................... 170,923,255 13,630,288 4,323,434 4,323,434 22,480,387 

Annualized Cost * ................................................................. 19,028,293 1,517,413 481,313 481,313 2,502,663

* Present value and annualized values are based on a two percent (2%) discount rate. 

TABLE 34—TOTAL TRANSFER PAYMENTS BY REGISTRATION

[High] 

Year 

Telemedicine 

prescribingindividual 

($) 

State 

telemedicineindividual 

($) 

Conventionalplatform 

($) 

Telemedicine 

platform 

($) 

State 

telemedicineplatform 

($) 

1 ........................................................................................... 42,274,084 3,371,141 1,069,152 1,069,152 5,559,472 

2 ........................................................................................... 50,306,092 4,011,660 1,272,208 1,272,208 6,615,896 

3 ........................................................................................... 59,864,124 4,773,875 1,514,040 1,514,040 7,873,008 

4 ........................................................................................... 71,238,386 5,680,905 1,801,752 1,801,752 9,368,992 

5 ........................................................................................... 84,773,701 6,760,274 2,144,224 2,144,224 11,149,136 

6 ........................................................................................... 100,880,650 8,044,725 2,551,520 2,551,520 13,267,608 

7 ........................................................................................... 120,048,072 9,573,225 3,036,368 3,036,368 15,788,344 

8 ........................................................................................... 142,857,192 11,392,135 3,613,272 3,613,272 18,788,008 

9 ........................................................................................... 170,000,102 13,556,642 4,299,696 4,299,696 22,357,768 

10 ......................................................................................... 202,300,137 16,132,397 5,116,656 5,116,656 26,605,664 

Present Value * .................................................................... 913,025,030 72,809,126 23,092,483 23,092,483 120,077,218 

Annualized Cost * ................................................................. 101,643,906 8,105,587 2,570,806 2,570,806 13,367,780 

* Present value and annualized values are based on a two percent (2%) discount rate. 

G. Summary of Practitioner Costs, Cost 

Savings, Benefits, and Transfers 

The costs to practitioners and MLPs 

and registration fees (transfers) are 

summarized in Table 35 below. 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
6584 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

184Snoswell CL, Taylor ML, et al. Determining if 

Telehealth Can Reduce Health System Costs: 

Scoping Review. J Med internet Res. October 2020. 

185Amin 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; and https://

www.healthsystemtracker.org/brief/telehealthpayments-similar-early-in-the-pandemic/ 

#Average%20payment%20for%20evaluation%20

and%20management%20professional

%20claims%20by%20telehealth%20and%20inperson,%20among%20privately%

20insured,%202020 (Accessed 9/5/2023). 

186 Data from Pdmpassist.org (Accessed 

September 2023). 

187 Interstate PDMP Access and Data Sharing 

Alignment, Prescription Drug Monitoring Program 

Training and Technical Assistance Center (Jan. 

2021), https://www.pdmpassist.org/pdf/resources/ 

Interstate_PDMP_Access_and_Data_Sharing_

Alignment_20210125.pdf (Accessed October 23, 

2023). 

188 Data from Pdmpassist.org (Accessed October 

2023). 

189 Interstate PDMP Access and Data Sharing 

Alignment, Prescription Drug Monitoring Program 

Training and Technical Assistance Center (Jan. 

2021), https://www.pdmpassist.org/pdf/resources/ 

TABLE 35—SUMMARY OF PRACTITIONER AND MLP COSTS AND TRANSFERS

Year 

Low Moderate 

(primary) 

High 

Cost to 

practitioners 

and MLPS 

($ million) 

Transfers 

($ million) 

Cost to 

practitioners 

and MLPs 

($ million) 

Transfers 

($ million) 

Cost to 

practitioners 

and MLPs 

($ million) 

Transfers 

($ million) 

1 ............................................................... 0.55 0.82 13 19 36 53 

2 ............................................................... 0.56 0.84 14 20 43 63 

3 ............................................................... 0.57 0.85 14 21 51 76 

4 ............................................................... 0.58 0.87 15 22 60 90 

5 ............................................................... 0.60 0.89 16 23 72 107 

6 ............................................................... 0.61 0.91 16 25 85 127 

7 ............................................................... 0.62 0.92 17 26 102 151 

8 ............................................................... 0.63 0.94 18 27 121 180 

9 ............................................................... 0.65 0.96 19 28 144 215 

10 ............................................................. 0.66 0.98 20 30 171 255 

Present Value * ........................................ 5.40 8.05 145 216 774 1,152 

Annualized Cost ** ................................... 0.60 0.90 16 24 86 128 

* Present value and annualized values are based on a two percent (2%) discount rate. 

** Figures are rounded as shown. 

IV. Pharmacy Costs 

Under the proposed rule, pharmacies 

would be required to submit monthly 

reports in accordance with proposed 

§ 1304.60. DEA assumes similar reports 

are already being submitted to state 

PDMPs electronically and pharmacies 

would be able to submit reports as 

required by § 1304.60 with minimal 

additional costs. 

V. Healthcare System Costs and Cost 

Savings 

Based on the available research, DEA 

anticipates that there will be no 

significant net economic impact on 

healthcare systems due to the proposed 

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. However, evidence 

suggests that it does not routinely 

reduce the cost of care delivery for the 

health system as a whole.184 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.185

VI. State Costs 

The proposed rule immediately 

requires practitioners to complete a 

PDMP check of: (1) the state/territory 

where the patient is located; (2) the 

state/territory where the practitioner is 

located; and (3) any state/territory with 

PDMP reciprocity agreements with 

either the state/territory where the 

patient is located or the state/territory 

where the practitioner is located. 

However, three years after the proposed 

rule’s effective date, in order for 

Schedule II prescribing to continue 

across state lines, DEA is requiring that 

practitioners conduct PDMP checks for 

patients in all 50 states and any U.S. 

districts and territories that maintain a 

PDMP. Based on a September 2023 

analysis conducted by DEA of State 

PDMP participation, the average state, 

including the District of Columbia, only 

shares PDMP data with 30 other states, 

as can be seen in Table 36.186 Based on 

that study, California was the only state 

that does not share data with any other 

state or a U.S. district and territory. 

However, California now does share 

PDMP data with Oregon. Guam and 

Northern Mariana Islands both share 

with Nebraska and each other. Puerto 

Rico shares with 30 states plus the 

District of Columbia. 

TABLE 36—PDMP SHARING AMONG

50 STATES AND THE DISTRICT OF

COLUMBIA

Number of 

states sharing 

with 

Minimum ............................... 1 

Minimum* .............................. 10 

Average ................................ 30 

Median .................................. 32 

Maximum .............................. 45 

* Excluding California. 

This is a significant improvement 

since practitioners first gained access to 

PDMPs in 1990 and electronic sharing 

of PDMP data was started in 2010.187

Further, most states use the same PDMP 

interconnectivity hub, with the two 

primary ones being PMP InterConnect 

and RxCheck.188 However, even with 

these improvements and similarities, 

‘‘there are some variances when it 

comes to data sharing and integration 

(i.e., assigned user roles, patient 

matching methods, percentage of 

provider population integrated, 

retention of PDMP data or reports) that 

pose challenges’’ according to a report 

by the Prescription Drug Monitoring 

Program Training and Technical 

Assistance Center.189


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6585 

Interstate_PDMP_Access_and_Data_Sharing_

Alignment_20210125.pdf (Accessed October 23, 

2023). 

190Patrick, S.W., Fry, C.E., Jones, T.F., & Buntin, 

M.B. (2016). Implementation of prescription drug 

monitoring programs associated with reductions in 

opioid-related death rates. Health Affairs, 35(7), 

1324–1332. 

191 Integration & Expanding Prescription Drug 

Monitoring Program Data: Lessons from Nine 

States, CDC (Feb. 2017), https://www.cdc.gov/ 

drugoverdose/pdf/pehriie_report-a.pdf (Accessed 

10/23/2023). 

192See, 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. 

193 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 proposed NPRM and under the separate 

Expansion of Buprenorphine Treatment via 

Telemedicine Encounter final rule (RIN 1117– 

AB78). See, e.g., Tanz LJ, Jones CM, Davis NL, 

Compton WM, Baldwin GT, Han B, Volkow ND. 

Trends and Characteristics of BuprenorphineInvolved 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. 

DEA does not have a basis to 

determine what the cost and 

coordination hurdles are in trying to 

implement 50-state sharing of PDMP 

data or how much more PDMP data 

sharing would have happened without 

this rule. Based on a 2016 study, there 

is evidence that states who have 

implemented PDMPs had a decline in 

the rate of opioid-related deaths in the 

year after their inauguration and that 

those declines were strongest in states 

whose PDMPs had the most 

comprehensive and efficient features, 

such as more frequently updated 

data.190 DEA believes increased state 

sharing will produce similar results and 

that any costs associated with 

implementation will be surpassed by 

the benefit of lower opioid-related 

deaths. 

From 2012 to 2016, SAMHSA funded 

projects across nine states to, among 

other things, increase PDMP access 

across states.191 Based on a report from 

the CDC, these projects were successful 

in increasing interstate PDMP data 

sharing, and this sharing brought about 

a decrease in prescription opioid abuse. 

Accordingly, there is reason for 

optimism that states can implement 

sharing and that outside groups can 

have a positive impact as well. This 

proposed rule would not create any 

mandate for states. Any costs incurred 

in PDMP data sharing among states are 

incurred outside of this rule. Therefore, 

any cost to states as a result of this rule 

would be minimal. 

VII. Diversion 

Requiring an in-person medical 

evaluation serves as a safeguard against 

diversion, consistent with the Ryan 

Haight Act. Certain signs of diversion or 

misuse of controlled substances may go 

undetected without an in-person 

assessment, as some indicators are 

either essential to observe personally or 

are more reliably detected when face-toface. Without this safeguard, new 

diversion paradigms have emerged in 

telemedicine.192 Therefore, in the 

absence of an in-person medical 

evaluation requirement, DEA believes 

that other anti-diversion safeguards— 

such as those proposed in this NPRM— 

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, the 

intentionally concealed and frequently 

underreported nature of drug diversion 

makes these illicit activities inherently 

difficult to track.193 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. Arguably, data shedding more 

light on diversion rates could be pulled 

from state PDMPs; however, as 

discussed above, the fragmented nature 

of PDMPs across the states fails to 

provide a comprehensive set of 

standardized data. 

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 the 

proposed NPRM, DEA would be 

implementing a system requiring 

pharmacies to inform DEA monthly 

about practitioner special registration 

prescriptions in accordance with 

proposed § 1304.60, which will allow 

DEA to collect more uniform and 

comprehensive data in order to carry 

out more quantitative analyses to 

evaluate the diversion of controlled 

substances via telemedicine. 

VIII. Summary of Economic Impact 

DEA estimates a cost savings to 

patients of $38.46 per first-time 

telemedicine visit that results in a 

controlled substance prescription. DEA 

estimates an annualized cost to 

practitioners, MLPs, and platforms of 

$1.61 for the labor cost of a registration 

application. DEA estimates a cost to 

practitioners and MLPs of $2.84 for 

annual reporting. DEA estimates a cost 

to practitioners and MLPs of $2.63 for 

PDMP checks. These unit costs were 

applied to the 10-year forecast of visits 

and registrations to develop a 10-year 

forecast of the cost savings, costs, and 

transfers. Furthermore, the annualized 

registration fees (transfers) were applied 

to the 10-year forecast of registrations to 

develop a 10-year forecast of transfers. 

The resulting cost savings, costs, and 

transfers for low, moderate (primary), 

and high estimates are shown in Table 

37 below. 

TABLE 37—SUMMARY OF ECONOMIC IMPACT ($ MILLIONS) 

Year 1 2 3 4 5 6 7 8 9 10 

Low Estimate 

Patient cost savings .................................. 0.78 0.80 0.81 0.83 0.85 0.86 0.88 0.90 0.92 0.93 

Costs ......................................................... 0.55 0.56 0.57 0.58 0.60 0.61 0.62 0.63 0.65 0.66 

Net Cost Savings ...................................... 0.23 0.23 0.24 0.24 0.25 0.25 0.26 0.26 0.27 0.27 


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194SUSB’s employer data contain the number of 

firms, number of establishments, employment, and 

annual payroll for employment size of firm 

categories by location and industry. A ‘‘firm’’ is 

defined as an aggregation of all establishments 

owned by a parent company (within a geographic 

location and/or industry) with some annual payroll. 

TABLE 37—SUMMARY OF ECONOMIC IMPACT ($ MILLIONS)—Continued 

Year 1 2 3 4 5 6 7 8 9 10 

Transfers ................................................... 0.82 0.84 0.85 0.87 0.89 0.91 0.92 0.94 0.96 0.98 

Moderate (Primary) Estimate 

Patient cost savings .................................. 18 19 20 21 22 23 25 26 27 28 

Costs ......................................................... 13 14 14 15 16 16 17 18 19 20 

Net Cost Savings ...................................... 5 6 6 6 7 7 7 8 8 8 

Transfers ................................................... 19 20 21 22 23 25 26 27 28 30 

High Estimate 

Patient cost savings .................................. 51 60 72 86 102 121 144 172 204 243 

Costs ......................................................... 36 43 51 60 72 85 102 121 144 171 

Net Cost Savings ...................................... 15 18 21 25 30 36 42 51 60 72 

Transfers ................................................... 53 63 76 90 107 127 151 180 215 255 

* Figures are rounded as shown, Net Cost Savings may not add exactly in the table. 

DEA calculated the present value and 

annualized figures for the cost savings, 

costs and transfers shown in Table 37. 

The resulting present value and 

annualized figures are shown in Table 

38 below. 

TABLE 38—NET PRESENT VALUE AND ANNUALIZED COST SAVINGS/COSTS ($ MILLIONS) 

Low Moderate 

(Primary) 

High 

h PV* A* PV* 

Patient—Cost Savings ............................. 7.7 0.85 205 23 1,097 122 

Practitioner cost ....................................... 5.4 0.60 145 16 774 86 

NPV (Cost Savings) ................................. 2.3 0.25 60 7 323 36 

Registration fee (Transfers) ..................... 8.1 0.90 216 24 1,152 128 

* Present value (PV) and annualized (A) values are based on a two percent (2%) discount rate. 

While DEA believes that the benefits 

of increased availability for treatment 

outweigh the dangers of a potential 

increase in diversion—so long as 

prescribers using the Special 

Registration for Telemedicine adhere to 

the safeguards inherent in the 

requirements of the proposed rule—the 

data system DEA is implementing will 

allow DEA to monitor the actual impact 

of the rule and be able to proactively 

make any necessary changes, either on 

the enforcement side or the regulatory 

side. 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act (5 

U.S.C. 601–612) (‘‘RFA’’), has reviewed 

this proposed rule and by approving it 

certifies that it will not have a 

significant economic impact on a 

substantial number of small entities. 

In accordance with the RFA, DEA 

evaluated the impact of this proposed 

rule on small entities. The proposed 

rule allows for DEA-registered 

physicians and MLPs, or practitioners, 

to apply for three types of Special 

Registrations: the (1) Telemedicine 

Prescribing Registration authorizing 

qualified practitioners to prescribe 

Schedule III–V controlled substances 

via telemedicine; (2) the Advanced 

Telemedicine Prescribing Registration, 

authorizing qualified specialized 

practitioners (e.g., psychiatrists, hospice 

care physicians) to prescribe Schedule 

II–V controlled substances via 

telemedicine, and (3) a Telemedicine 

Platform Registration, authorizing 

covered online telemedicine platforms, 

in their capacity as platform 

practitioners, to dispense Schedule II–V 

controlled substances. 

The proposed rule immediately 

requires practitioners to complete a 

PDMP check of (1) the state/territory 

where the patient is located; (2) the 

state/territory where the practitioner is 

located; and (3) any state/territory with 

PDMP reciprocity agreements with 

either the state/territory where the 

patient is located or the state/territory 

where the practitioner is located. With 

a delayed effective date of three years, 

it requires a PDMP review of all 50 

states and any U.S. districts and 

territories that maintain a PDMP prior to 

issuing a telemedicine prescription 

under the Special Registration. 

A significant number of physicians 

and MLPs work in offices and 

institutions that meet the RFA’s 

definition of small entities. To estimate 

the number of affected entities, DEA 

first determined the North American 

Industry Classification System 

(‘‘NAICS’’) codes that most closely 

represent businesses that employ the 

potential applicants for the Special 

Registrations for Telemedicine. Then, 

DEA researched economic data for those 

codes. The source of the economic data 

is the Small Business Administration 

(‘‘SBA’’), Office of Advocacy, and is 

based on data provided by the U.S. 

Census Bureau, Statistics of U.S. 

Businesses (‘‘SUSB’’).194 The following 

business NAICS codes are estimated to 

represent businesses that employ the 

affected persons (potential applicants): 

• 621111—Offices of Physicians, 

Except Mental Health Specialists 

• 621112—Offices of Physicians, 

Mental Health Specialists 

• 621420—Outpatient Mental Health 

and Substance Abuse Centers 

• 622210—Psychiatric and Substance 

Abuse Hospitals 

SUSB data contains the number of 

firms by size ranges for each of the 

NAICS codes. For the purposes of this 

analysis, the term ‘‘firm’’ as defined in 

the SUSB is used interchangeably with 

‘‘entity’’ as defined in the RFA. 

To estimate the number of affected 

entities that are small entities, DEA 

compared the SUSB data for the number 


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195U.S. Small Business Administration, Table of 

size standards, Effective March 17, 2023, https://

www.sba.gov/document/support-table-sizestandards (https://www.sba.gov/sites/default/files/ 

2023-06/Table%20of%20Size%20Standards_

Effective%20March%2017%2C%202023_.xlsx) 

(Accessed October 18, 2024). 

196SUSB, 2017 SUSB Annual Data Tables by 

Establishment Industry, U.S., Data by Enterprise 

Receipts Size, 6-digit NAICS, https://

www.census.gov/data/tables/2017/econ/susb/2017- 

susb-annual.html (https://www2.census.gov/ 

programs-surveys/susb/tables/2017/us_6digitnaics_

rcptsize_2017.xlsx) (Accessed October 20, 2024). 

197Bureau of Labor Statistics, Occupational 

Employment and Wages, May 2023 (29–1210 

Physicians), annual mean wage, https://

www.bls.gov/oes/2023/may/oes_nat.htm (Accessed 

10/18/2024). While the weighted average of the 29– 

1210 Physicians and 29–1240 Surgeons is used to 

calculate costs earlier in the document, here, the 

total costs and fees is compared to the loaded 

median annual wages for 29–1210 Physicians only. 

29–1210 is the large majority and this analysis 

examines the impact on this occupation with the 

lower wage. 

198Bureau of Labor Statistics, Occupational 

Employment and Wages, May 2023, 29–1071 

Physician Assistants, median hourly wage https:// 

www.bls.gov/oes/2023/may/oes_nat.htm. (Accessed 

10/18/2024). 

199Bureau of Labor Statistics, Occupational 

Employment and Wages, May 2023, 29–1171 Nurse 

Practitioners, annual mean wage, https://

www.bls.gov/oes/2023/may/oes_nat.htm. (Accessed 

10/18/2024). 

of firms in various firm size ranges with 

SBA size standards for each of the 

representative NAICS codes. The SBA 

size standard is the firm size based on 

the number of employees or annual 

receipts depending on industry. The 

SBA size standards for NAICS codes 

621111, 621112, 621420, and 622210 are 

annual receipts of $16.0 million, $13.5 

million, $19.0 million, and $47.0 

million, respectively.195

The firms in each size range below the 

SBA size standard are small firms. The 

number of firms below the SBA size 

standard was added to determine the 

total number of small firms in each 

NAICS code. DEA estimates that a total 

of 175,503 entities are affected by this 

proposed rule, of which 172,436 (98.25 

percent) are small entities. The analysis 

is summarized in Table 39 below.196

TABLE 39—NUMBER OF AFFECTED ENTITIES AND SMALL ENTITIES

NAICS Code Number of 

firms 

SBA size 

standard 

($) 

Number of 

small firms 

621111—Offices of Physicians, Except Mental Health Specialists ............................................ 161,286 16,000,000 157,563 

621112—Offices of Physicians, Mental Health Specialists ......................................................... 10,561 13,500,000 10,400 

621420—Outpatient Mental Health and Substance Abuse Centers ........................................... 6,523 19,000,000 5,849 

622210—Psychiatric and Substance Abuse Hospitals ............................................................... 396 47,000,000 200 

Total ...................................................................................................................................... 178,766 ........................ 174,012 

Percent of Total .................................................................................................................... ........................ ........................ 97.3 percent 

The cost of the proposed rule impacts 

the affected entities and small entities 

on a ‘‘per person’’ basis. Rather than 

estimating the number of physicians 

and MLPs per firm, then the cost per 

firm, then whether the cost is 

significant, DEA employed a more direct 

approach based on the following logic: 

• In order to continue as a financially 

stable entity, the affected firms must 

generate enough revenue to pay the 

wages of physicians and MLPs, and 

other operating expenses. 

• Therefore, revenue for firms must 

be greater than the wages paid to 

practitioners. 

• Therefore, if the cost of the 

proposed rule is not economically 

significant when compared to 

individual wages for practitioners, the 

cost of the proposed rule is not 

economically significant when 

compared to the annual revenue of the 

firms. 

In this analysis DEA has assumed a 

practitioner falls under the platform 

registration even though that 

registration is designed for telemedicine 

companies who are serving as 

intermediaries between patients and 

clinician practitioners, which is 

expected to exclude physician offices 

that have only one physician. If the cost 

is not burdensome for a single physician 

office, then it would not, presumably, be 

a burden for larger offices as well. 

As covered above, DEA estimates the 

cost to apply at $4.83 per application 

and that each registrant would apply for 

2.5 individual Special Registrations (1 

initial and 1.5 state) and 3.5 platform 

registrations (1 conventional, 1 initial 

telemedicine, and 1.5 state) for a total of 

6 (2.5 + 3.5), at an annual rate of 2 

Special Registrations per year (6⁄3), 

giving a total cost of $9.66 ($4.83 × 2). 

This would also mean there would be 

fees of $888 for the platform 

conventional registration, $1,776 (888 × 

2) for both the individual and platform 

initial Special Registration and $150 

($50 × 3) for 3 special state registrations, 

for a total of $2,814 ($888 + $1,776 + 

$150), or $938 per year ($2,814/3). 

DEA estimates the cost for reporting 

to DEA would be $2.84 per report. With 

one report per year, that would be an 

annual cost of $2.84. DEA estimates the 

cost per PDMP check for physicians, 

physician assistants, and nurse 

practitioners is $3.20, $1.54, and $1.50, 

respectively. DEA estimates the number 

of new PDMP checks per year by taking 

the total number of new PDMP checks 

and dividing by the number of Special 

Registrations. For the high estimate, the 

number of new PDMP checks per year 

is 83 (63,172,320/761,781). Being 

conservative, DEA used the year 10 

figures. The total annual cost of the new 

PDMP checks per year is $266 (84 × 

$3.20), $128 (83 × $1.54), and $125 (83 

× 1.50), respectively for physicians, 

physician assistants, and nurse 

practitioners. 

The average annual total economic 

impact for each registrant who 

prescribes under this proposed rule is 

then the combination of the PDMP 

check cost, registration time cost, 

reporting cost, and annualized 

registration fee. For physicians, 

physician assistants, and nurse 

practitioners, this is $1,210 ($266 + 

$3.22 + $2.84 + $938), $1,072 ($128 + 

$3.22 + $2.84 + $938), and $1,069 ($125 

+ $3.22 + $2.84 + $938), respectively. 

The average annual total economic 

impacts are compared to the loaded 

annual mean wages for physicians and 

MLPs (physician assistants and nurse 

practitioners). Based on the Bureau of 

Labor Statistics’ (BLS) Occupational 

Employment and Wages data, DEA 

estimates an annual mean wage of 

$263,840 for physicians (occupation 

code 29–1210),197 $130,490 for 

physician assistants (occupation code 

29–1071),198 and $128,490 for nurse 

practitioners (occupation code 29– 

1171).199 Based on the previously 

calculated load of 45.3 percent, the 

loaded annual mean wages are then 

$383,360 ($263,840 × 1.453), $189,602 

($130,490 × 1.453), and $186,696 

($128,490 × 1.453), respectively. 

The total annual fees and costs are 

then 0.32 percent ($1,210/$383,360), 


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6588 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

0.57 percent ($1,072/$189,602), and 

0.57 percent ($1,069/$186,696) of 

loaded annual wages for physicians, 

physician assistants, and nurse 

practitioners, respectively. Table 40 

presents the details of the calculation. 

TABLE 40—COSTS AND FEES AS PERCENT OF WAGES

Registration cost 

($) 

Reporting 

cost 

($) 

PDMP 

check 

cost 

($) 

Annualized 

registration 

fee cost 

($) 

Total cost 

and fees 

($) 

Loaded annual mean 

wage 

($) 

Costs and 

fees as percent of 

wage 

(percent) 

Physicians .................................................................. 3.22 2.84 266 938 1,210 383,360 0.32 

Physician Assistants .................................................. 3.22 2.84 128 938 1,072 189,602 0.57 

Nurse Practitioners ..................................................... 3.22 2.84 125 938 1,069 186,696 0.57 

The economic impact of applying for 

the Special Registration for 

Telemedicine represents a small fraction 

(0.32 percent, 0.57 percent, and 0.57 

percent) of annual wages. DEA estimates 

the proposed rule will not have a 

significant economic impact on 

individual physicians and MLPs. The 

small entities that employ the 

potentially affected physicians and 

MLPs are expected to generate enough 

revenue to pay their wages. Therefore, 

DEA concludes the proposed rule will 

not have a significant economic impact 

on a substantial number of small 

entities. 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

DEA has determined that this 

proposed rule may have Tribal 

implications, as defined by Executive 

Order 13175. The determination that 

this proposed rule will have Tribal 

implications is, in part, based off the 

several public comments made by Tribal 

organizations on the 2023 General 

Telemedicine NPRM and the 

Buprenorphine NPRM, stating that the 

requirements in those two proposed 

rules would have a substantial impact 

on Tribal communities. The most 

prominent concerns of the Tribal 

organizations involved the extreme 

remoteness and practitioner shortages 

faced by some Tribal communities. 

Specifically, as a result of these 

obstacles to care, the Tribal 

communities noted the challenges 

posed by, as proposed in the 2023 

NPRMs, necessitating an in-person 

medical examination to obtain 

prescriptions for certain substances, as 

well as the 30-day telemedicine 

prescription supply limit. On June 13 

and 27, 2024, OTJ and DEA hosted two 

Tribal consultations to have broad 

discussions regarding the practice of 

telemedicine with Tribal communities. 

Many of the Tribal organizations that 

participated in the two Tribal 

consultations reiterated their concerns 

about any telemedicine rule that would 

require an in-person medical 

examination to obtain prescriptions for 

certain substances and a 30-day 

telemedicine prescription supply limit. 

After carefully considering the 

information and insights shared in the 

public comments to the two 2023 

NPRMs, during the Telemedicine 

Listening Sessions, and during the June 

2024 Tribal Consultations, DEA 

reevaluated its approach and 

determined that the best course of 

action was to proceed with the 

promulgation of a Special Registration 

rule. Notably, this proposed Special 

Registration rule no longer contains an 

in-person medical examination 

requirement for certain substances and 

no longer contains a 30-day 

telemedicine prescription supply limit 

requirement; DEA believes these 

changes have largely addressed the 

prominent concerns raised by Tribes. 

DEA encourages Tribal members and 

entities to submit public comments on 

this Special Registration NPRM. 

Furthermore, it intends to continue 

Tribal consultations on Telemedicine, 

including the proposed requirements of 

the Special Registration NPRM, to 

ensure meaningful collaboration with 

Tribal governments impacted by DEA’s 

telemedicine policies. 

Paperwork Reduction Act of 1995 

This proposed rule would impose 

new collections and modify existing 

collections of information under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501–3521. DEA has identified 

the following collection(s) of 

information related to this proposed 

rule. An agency may not conduct or 

sponsor, and a person is not required to 

respond to a collection of information 

unless it displays a valid OMB control 

number. Copies of existing information 

collections approved by OMB may be 

obtained at http://www.reginfo.gov/ 

public/do/PRAMain. 

A. Collections of Information Associated 

With the Proposed Rule 

1. Title: Application for Registration, 

Registration Renewal, Special 

Registration for Telemedicine, and 

Changes and Modifications to Special 

Registration for Telemedicine, Forms 

DEA–224/224A/224S/224S–M 

OMB Control Number: 1117–0014 

Form Number: DEA–224/DEA–224A/ 

DEA–224S/224S–M 

DEA is proposing to amend its 

regulations by creating two new forms 

for all Special Registration applicants to 

use when applying for or modifying a 

Special Registration for Telemedicine 

and a State Telemedicine Registration. 

DEA Form 224S (Application for 

Special Registration for Telemedicine 

Under the Controlled Substances Act) 

will allow Special Registration 

applicants to use one form to apply for 

the Telemedicine Prescribing 

Registration (CS III–V), the Advanced 

Telemedicine Prescribing Registration 

(CS II–V), the Telemedicine Platform 

Registration (CS II–V), and the State 

Telemedicine Registration for each state 

in which a patient will be located. 

Special Registration applicants will be 

required to provide one Special 

Registered Location. Platform 

practitioners will be required to disclose 

all employment, contractual 

relationships, or professional affiliations 

with any clinician special registrant and 

Online Pharmacy and their respective 

registration numbers. Clinician 

practitioners will be required to disclose 

all employment, contractual 

relationships, and professional 

affiliations, including with any covered 

online telemedicine platforms and the 

respective covered online telemedicine 

platform’s Telemedicine Platform 

Special Registration number; their 

practice specialties; and attest to their 

ability and intention to check relevant 

state PDMPs prior to issuing a special 

registration prescription. All Special 

Registration applicants will also be 

required to attest to having devised, and 

committing to maintain, anti-diversion 


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policies and procedures and to the facts 

and circumstances that form the basis 

for their legitimate need for a Special 

Registration for Telemedicine. 

Additionally, those practitioners that 

are exempt from obtaining State 

Telemedicine Registrations will be 

required to identify all states in which 

patients will be located when being 

treated via telemedicine. 

DEA Form 224S–M (Application for 

Changes and Modifications to Special 

Registration) provides special 

registrants with a means to comply with 

the proposed requirement of notifying 

DEA, within 14 business days, of any 

changes to the information provided in 

the Special Registration application 

(Form 224S); such changes include if a 

clinician special registrant becomes 

employed by, contracts with, or 

otherwise becomes professionally 

affiliated with a new DTC online 

telemedicine platform not previously 

disclosed on the original Form 224S or 

if any clinician special registrant or 

platform special registrant needs to 

make modifications to their Special 

Registration. The information submitted 

on these two forms will enhance 

transparency, patient safety, and antidiversion efforts. 

The below estimates are based on the 

‘‘moderate (primary)’’ estimates made in 

the E.O. 12866 section above. DEA 

estimates the following number of 

respondents and burden associated with 

this collection of information: 

• Number of respondents: 670,916 

• Frequency of response: 1 per year 

• Number of responses: 718,917 

• Burden per response: 0.20 hours 

(calculated) 

• Total annual hour burden: 144,200 

hours 

2. Title: Special Registration 

Recordkeeping and Prescribing 

Requirements 

OMB Control Number: 1117–New 

Form Number: N/A 

Clinician special registrants will 

remain subject to existing recordkeeping 

and prescribing requirements. However, 

under this rule, DEA is proposing 

additional requirements under the 

Special Registration framework. 

Clinician special registrants would be 

required to maintain all records arising 

from telemedicine encounters under the 

Special Registration framework at the 

special registered location for a 

minimum of two (2) years. The clinician 

special registrant will be required to 

maintain a record of the date and time 

of the telemedicine encounter, the 

address of the patient during the 

telemedicine encounter, and the home 

address of the patient. This proposed 

requirement enhances public safety by 

making detection of diversion patterns 

and illegitimate prescribing practices 

easier to spot during DEA 

investigations. It will also alleviate the 

practical burden for special registrants 

by centralizing recordkeeping at the 

special registered location rather than 

requiring special registrants to maintain 

records in every state where 

telemedicine patients are located. 

Additionally, this proposed rule will 

require, in addition to the requirements 

of a prescription found in 21 CFR 

1306.05(a), two additional elements for 

special registration prescriptions to 

include: (1) the Special Registration 

numbers of the clinician practitioner 

and, if a platform practitioner facilitated 

the prescription, the platform 

practitioner; and (2) State Telemedicine 

Registration number of the clinician 

practitioner and, if a platform 

practitioner facilitated the prescription, 

the platform practitioner. If a clinician 

special registrant is exempt from 

obtaining a State Telemedicine 

Registration, the clinician special 

registrant will be required to instead 

provide a notation on the prescription 

identifying the state in which the 

patient is located. This information will 

provide the pharmacist with the 

necessary information to determine 

whether the clinician practitioner has 

the authority to prescribe, and the 

platform practitioner has the authority 

to dispense, Schedule II controlled 

substances, and provide the pharmacist 

with the information necessary to verify 

that special registration prescriptions 

are prescribed and dispensed by special 

registrants authorized within the 

appropriate state. 

This proposed rule requires that 

clinician special registrants, or a 

delegated employee or contractor under 

the direct supervision of the clinician 

special registrant, verify the identity of 

patients seeking treatment via 

telemedicine by requiring that the 

patient present a state or federal 

government-issued photo identification 

card or acceptable alternative forms of 

identification through the camera of the 

audio-video telecommunications 

system. The clinician special registrant 

will be required to photograph the 

patient presenting their photo 

identification card or other acceptable 

documents during an initial 

telemedicine encounter or accept a copy 

of such identification card or document 

and will be required to maintain this 

photographic record for a minimum of 

two (2) years. The photographic records, 

or copies of such, will be securely 

stored in the patient’s medical record or 

chart to ensure patient privacy. This 

requirement ensures that patients’ 

identities are verified, and the 

photographic record establishes a clear 

link between the patient’s identity and 

the special registration prescription. 

Platform special registrants will be 

required to maintain certain clinician 

special registrant records insomuch as 

that platform special registrant has a 

covered platform relationship with the 

clinician special registrant. Such 

records include documents related to 

verification of the clinical special 

registrant’s credentials; employment 

contracts and any other contract 

between the platform special registrant 

and clinician special registrant; and any 

disciplinary actions or sanctions, or 

documentation of complaints, disputes, 

or incidents involving the practice of 

telemedicine. The platform special 

registrant will be required to maintain 

and update the credential verification 

and conduct-related records for a 

minimum of two (2) years. This 

requirement will help to address any 

potential issues of diversion, 

misconduct, or inadequate screening 

procedures and provides additional 

regulatory oversight over remote 

prescribing. 

This proposed rule will require, in 

addition to the requirements of a 

prescription found in 21 CFR 

1306.05(a), two additional elements for 

special registration prescriptions to 

include: (1) the Special Registration 

numbers of the clinician practitioner 

and, if a platform practitioner facilitated 

the prescription, the platform 

practitioner; and (2) State Telemedicine 

Registration number of the clinician 

practitioner and, if a platform 

practitioner facilitated the prescription, 

the platform practitioner. If a clinician 

special registrant is exempt from 

obtaining a State Telemedicine 

Registration, the clinician special 

registrant will be required to instead 

provide a notation on the prescription 

identifying the state in which the 

patient is located. This information will 

provide the pharmacist with the 

necessary information to determine 

whether the clinician practitioner has 

the authority to prescribe, and the 

platform practitioner has the authority 

to dispense, Schedule II controlled 

substances, and provide the pharmacist 

with the information necessary to verify 

that special registration prescriptions 

are prescribed and dispensed by special 

registrants authorized within the 

appropriate state. 

The below estimates are based on the 

‘‘moderate (primary)’’ estimates made in 

the E.O. 12866 section above. DEA 

estimates the following number of 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
6590 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

respondents and burden associated with 

this collection of information: 

• Number of respondents: 57,552 

• Frequency of response: 174.26562 (as 

needed, calculated) 

• Number of responses: 10,029,335 

• Burden per response: 0.0008602 

(calculated) 

• Total annual hour burden: 8,627 

hours 

3. Title: Special Registration Reporting 

Requirements 

OMB Control Number: 1117-New 

Form Number: N/A 

This proposed rule will require both 

individual special registrants and 

platform special registrants to 

electronically report to DEA under 21 

CFR 1304.61, on an annual basis, the 

total number of new patients in each 

state where at least one special 

registration prescription for a Schedule 

II controlled substance and certain 

Schedule III–V controlled substances, 

including Ketamine, Tramadol, and any 

depressant constituting a 

benzodiazepine, has been issued; the 

total number of special registration 

prescriptions for Schedule II controlled 

substances issued by the special 

registrant in aggregate and across all 

states; and the total number of special 

registration prescriptions for certain 

Schedule III–V controlled substances, 

including Ketamine, Tramadol, and any 

depressants constituting a 

benzodiazepines, which were issued by 

the special registrant, in aggregate and 

across all states. Amid the ongoing 

opioid epidemic, this vital information 

will provide DEA with accurate and up 

to date data on the prescribing of 

controlled substances via telemedicine. 

This proposed rule will also require 

pharmacies to electronically report, 

within the first seven (7) days of the 

start of every month, aggregate data for 

the special registration prescriptions 

filled during the preceding month for 

each Schedule II controlled substance 

and certain Schedule III–V controlled 

substances, including Ketamine, 

Tramadol, and any depressant 

constituting a benzodiazepine. For each 

of these controlled substances, the 

pharmacy will be required to report the 

number of prescriptions filled, the 

volume of the controlled substance 

dispensed, and the number of patients 

prescribed the controlled substance. 

These requirements provide valuable 

oversight of telemedicine prescriptions 

under the Special Registration, enable 

the detection of irregularities or 

suspicious prescribing and dispensing 

practices, and will help DEA 

understand any shifts in demand for 

medications via telemedicine. 

The below estimates are based on the 

‘‘moderate (primary)’’ estimates made in 

the E.O. 12866 section above. DEA 

estimates the following number of 

respondents and burden associated with 

this collection of information: 

• Number of respondents: 69,134 

• Frequency of response: 6.950774 

(calculated) 

• Number of responses: 871,488 

• Burden per response: 0.006863 

hours (calculated) 

• Total annual hour burden: 5,981 

hours 

B. Request for Comments Regarding the 

Proposed Collections of Information 

Written comments and suggestions 

from the public and affected entities 

concerning the proposed collections of 

information are encouraged. Under the 

PRA, DEA is required to provide a 

notice regarding the proposed 

collections of information in the Federal 

Register with the notice of proposed 

rulemaking and solicit public comment. 

Pursuant to section 3506(c)(2) of the 

PRA (44 U.S.C. 3506(c)(2)), DEA solicits 

comment on the following issues: 

• Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of DEA, 

including whether the information will 

have practical utility. 

• The accuracy of DEA’s estimate of 

the burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used. 

• Recommendations to enhance the 

quality, utility, and clarity of the 

information to be collected. 

• Recommendations to minimize the 

burden of the collection of information 

on those who are to respond, including 

through the use of automated collection 

techniques or other forms of information 

technology. 

All comments concerning collections 

of information under the Paperwork 

Reduction Act must be submitted to the 

Office of Information and Regulatory 

Affairs, OMB, Attention: Desk Officer 

for DOJ, Washington, DC 20503. Please 

state that your comments refer to RIN 

1117–AB40/Docket No. DEA–407. All 

comments must be submitted to OMB 

on or before March 18, 2025. [‘‘The final 

rule will respond to any OMB or public 

comments on the information collection 

requirements contained in this proposed 

rule.’’] 

If you need a copy of the proposed 

information collection instrument(s) 

with instructions or additional 

information, please contact the 

Regulatory Drafting and Policy Support 

Section (DPW), Diversion Control 

Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (571) 776–3882. 

Unfunded Mandates Reform Act of 

1995 

The estimated annual impact of this 

proposed rule is minimal. Thus, DEA 

has determined in accordance with the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.) that this 

action would not result in any federal 

mandate that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted for inflation) in any one year. 

Therefore, neither a Small Government 

Agency Plan nor any other action is 

required under provisions of UMRA. 

List of Subjects 

21 CFR Part 1300 

Chemicals, Drug traffic control. 

21 CFR Part 1301 

Administrative practice and 

procedure, Drug traffic control, Exports, 

Imports, Prescription 

drugs, Security measures. 

21 CFR Part 1304 

Drug traffic control, Reporting and 

recordkeeping requirements. 

21 CFR Part 1306 

Administrative practice and 

procedure, Drug traffic control, 

Prescription drugs, Reporting and 

recordkeeping requirements. 

For the reasons set out above, the 

Drug Enforcement Administration 

proposes to amend 21 CFR parts 1300, 

1301, 1304, and 1306 as follows: 

PART 1300—DEFINITIONS 

■ 1. Revise the authority citation for part 

1300 to read as follows: 

Authority: 21 U.S.C. 802, 821, 822, 829, 

831(h), 871(b), 951, 958(f). 

■ 2. In § 1300.01(b) the add the term 

‘‘Clinician practitioner’’ and revise the 

term ‘‘Institutional practitioner’’ shall be 

revised, as follows: 

§ 1300.01 Definitions related to controlled 

substances 

* * * * * 

Clinician practitioner is an individual 

practitioner who provides direct patient 

care or assesses, diagnoses, or treats 

medical conditions. 

* * * * * 

Institutional practitioner means a 

hospital or other person (other than an 

individual) licensed, registered, or 

otherwise permitted, by the United 

States or the jurisdiction in which it 


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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6591 

practices, to dispense a controlled 

substance in the course of professional 

practice, but does not include a 

pharmacy or covered online 

telemedicine platform. 

* * * * * 

■ 3. Revise and republish § 1300.04 to 

read as follows: 

§ 1300.04 Definitions relating to the 

dispensing of controlled substances by 

means of the internet. 

Any term not defined in this part or 

elsewhere in this chapter shall have the 

definition set forth in sections 102 and 

309 of the Act (21 U.S.C. 802, 829). 

Advanced Telemedicine Prescribing 

Registration means a type of Special 

Registration for Telemedicine in which 

the registered practitioner is authorized 

to prescribe Schedules II through V 

controlled substances through the 

practice of telemedicine under 21 U.S.C. 

802(54)(E). 

Audio-video telecommunications 

system means the multimedia 

communications equipment that 

includes, at a minimum, audio and 

video equipment permitting two-way, 

real-time interactive communication 

between the patient and practitioner, 

mid-level practitioner, or pharmacist. 

Clinician special registrant means a 

special registrant issued either the 

Telemedicine Prescribing Registration 

or the Advanced Telemedicine 

Prescribing Registration under 

1301.11(c)(2) and (3) of this chapter, 

respectively. 

Covered online telemedicine platform 

means an entity that facilitates 

connections between patients and 

clinician practitioners, via an audiovideo telecommunications system, for 

the diagnosis and treatment of patients 

that may result in the prescription of 

controlled substances, but is not a 

hospital, clinic, local in-person medical 

practice, or insurance provider, and 

meets one or more of the following 

criteria: 

(1) The entity explicitly promotes or 

advertises the prescribing of controlled 

substances through the platform; 

(2) The entity has financial interests, 

whether direct incentives or otherwise, 

tied to the volume or types of controlled 

substance prescriptions issued through 

the platform, including but not limited 

to, ownership interest in pharmacies 

used to fill patients’ prescriptions, or 

rebates from those pharmacies; 

(3) The entity exerts control or 

influence on clinical decision-making 

processes or prescribing related to 

controlled substances, including, but 

not limited to: prescribing guidelines or 

protocols for clinician practitioners 

employed or contracted by the platform; 

consideration of clinician practitioner 

prescribing rates in the entity’s hiring, 

retention, or compensation decisions; 

imposing explicit or de facto prescribing 

quotas; directing patients to preferred 

pharmacies; and/or 

(4) The entity has control or custody 

of the prescriptions or medical records 

of patients who are prescribed 

controlled substances through the 

platform. 

Covered platform relationship means 

the formal association between a 

covered online telemedicine platform 

and a clinician practitioner it directly 

employs, contracts with, or is otherwise 

professionally affiliated with to 

introduce or facilitate connections 

between patients seeking remote 

medical consultations and the 

individual practitioner, via an audiovideo telecommunications system, for 

the diagnosis of patients and the 

treatment of those patients via 

prescription of controlled substances. 

Covering practitioner means, with 

respect to a patient, a practitioner who 

conducts a medical evaluation (other 

than an in-person medical evaluation) at 

the request of a practitioner who: 

(1) Has conducted at least one inperson medical evaluation of the patient 

or an evaluation of the patient through 

the practice of telemedicine, within the 

previous 24 months; and 

(2) Is temporarily unavailable to 

conduct the evaluation of the patient. 

Deliver, distribute, or dispense by 

means of the internet refers, 

respectively, to any delivery, 

distribution, or dispensing of a 

controlled substance that is caused or 

facilitated by means of the internet. 

Filling new prescriptions for 

controlled substances in Schedule III, 

IV, or V means filling a prescription for 

an individual for a controlled substance 

in Schedule III, IV, or V, if: 

(1) The pharmacy dispensing that 

prescription has previously dispensed 

to the patient a controlled substance 

other than by means of the internet and 

pursuant to the valid prescription of a 

practitioner that meets the applicable 

requirements of subsections (b) and (c) 

of section 309 of the Act (21 U.S.C. 829) 

and §§ 1306.21 and 1306.22 of this 

chapter (for purposes of this definition, 

such a prescription shall be referred to 

as the ‘‘original prescription’’); 

(2) The pharmacy contacts the 

practitioner who issued the original 

prescription at the request of that 

individual to determine whether the 

practitioner will authorize the issuance 

of a new prescription for that individual 

for the controlled substance described 

in paragraph (d)(1) of this section (i.e., 

the same controlled substance as 

described in paragraph (d)(1)); and 

(3) The practitioner, acting in the 

usual course of professional practice, 

determines there is a legitimate medical 

purpose for the issuance of the new 

prescription. 

Homepage means the opening or main 

page or screen of the website of an 

online pharmacy that is viewable on the 

internet. 

Hospice care means a set of special 

services that are provided to individuals 

who are terminally ill. The focus is on 

comfort, not on curing an illness. 

Hospice programs can be delivered in a 

person’s home or in a hospice center. 

In-person medical evaluation means a 

medical evaluation that is conducted 

with the patient in the physical 

presence of the practitioner, without 

regard to whether portions of the 

evaluation are conducted by other 

health professionals. Nothing in this 

paragraph shall be construed to imply 

that one in-person medical evaluation 

demonstrates that a prescription has 

been issued for a legitimate medical 

purpose within the usual course of 

professional practice. 

Internet means collectively the 

myriad of computer and 

telecommunications facilities, including 

equipment and operating software, 

which comprise the interconnected 

worldwide network of networks that 

employ the Transmission Control 

Protocol/internet Protocol, or any 

predecessor or successor protocol to 

such protocol, to communicate 

information of all kinds by wire or 

radio. 

Local in-person medical practice 

means a medical practice where all its 

offices are within 100 miles of each 

other, and where less than 50 percent of 

the total prescriptions for controlled 

substances collectively issued by the 

practice’s physicians and mid-level 

practitioners are issued via 

telemedicine, in any given calendar 

month, but is not a hospital, clinic, or 

insurance provider. 

Online pharmacy means a person, 

entity, or internet site, whether in the 

United States or abroad, that knowingly 

or intentionally delivers, distributes, or 

dispenses, or offers or attempts to 

deliver, distribute, or dispense, a 

controlled substance by means of the 

internet. The term includes, but is not 

limited to, a pharmacy that has obtained 

a modification of its registration 

pursuant to §§ 1301.13 and 1301.19 of 

this chapter that currently authorizes it 

to dispense controlled substances by 

means of the internet, regardless of 

whether the pharmacy is currently 

dispensing controlled substances by 


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6592 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

means of the internet. The term does not 

include: 

(1) Manufacturers or distributors 

registered under subsection (a), (b), (d), 

or (e) of section 303 of the Act (21 

U.S.C. 823(a), (b), (d), or (e)) (§ 1301.13 

of this chapter) who do not dispense 

controlled substances to an unregistered 

individual or entity; 

(2) Nonpharmacy practitioners who 

are registered under section 303(f) of the 

Act (21 U.S.C. 823(f)) (§ 1301.13 of this 

chapter) and whose activities are 

authorized by that registration; 

(3) Any hospital or other medical 

facility that is operated by an agency of 

the United States (including the Armed 

Forces), provided such hospital or other 

facility is registered under section 303(f) 

of the Act (21 U.S.C. 823(f)) (§ 1301.13 

of this chapter); 

(4) A health care facility owned or 

operated by an Indian tribe or tribal 

organization, only to the extent such 

facility is carrying out a contract or 

compact under the Indian Self– 

Determination and Education 

Assistance Act; 

(5) Any agent or employee of any 

hospital or facility referred to in 

paragraph (h)(3) or (h)(4) of this section, 

provided such agent or employee is 

lawfully acting in the usual course of 

business or employment, and within the 

scope of the official duties of such agent 

or employee, with such hospital or 

facility, and, with respect to agents or 

employees of health care facilities 

specified in paragraph (h)(4) of this 

section, only to the extent such 

individuals are furnishing services 

pursuant to the contracts or compacts 

described in such paragraph; 

(6) Mere advertisements that do not 

attempt to facilitate an actual 

transaction involving a controlled 

substance; 

(7) A person, entity, or internet site 

that is not in the United States and does 

not facilitate the delivery, distribution, 

or dispensing of a controlled substance 

by means of the internet to any person 

in the United States; 

(8) A pharmacy registered under 

section 303(f) of the Act (21 U.S.C. 

823(f)) (§ 1301.13 of this chapter) whose 

dispensing of controlled substances via 

the internet consists solely of: 

(i) Refilling prescriptions for 

controlled substances in Schedule III, 

IV, or V, as defined in paragraph (k) of 

this section; or 

(ii) Filling new prescriptions for 

controlled substances in Schedule III, 

IV, or V, as defined in paragraph (d) of 

this section; 

(9)(i) Any registered pharmacy whose 

delivery, distribution, or dispensing of 

controlled substances by means of the 

internet consists solely of filling 

prescriptions that were electronically 

prescribed in a manner authorized by 

this chapter and otherwise in 

compliance with the Act. 

(ii) A registered pharmacy will be 

deemed to meet this exception if, in 

view of all of its activities other than 

those referred to in paragraph (h)(9)(i) of 

this section, it would fall outside the 

definition of an online pharmacy; 

(10)(i) Any registered pharmacy 

whose delivery, distribution, or 

dispensing of controlled substances by 

means of the internet consists solely of 

the transmission of prescription 

information between a pharmacy and an 

automated dispensing system located in 

a long term care facility when the 

registration of the automated dispensing 

system is held by that pharmacy as 

described in §§ 1301.17 and 1301.27 

and the pharmacy is otherwise 

complying with this chapter. 

(ii) A registered pharmacy will be 

deemed to meet this exception if, in 

view of all of its activities other than 

those referred to in paragraph (h)(10)(i) 

of this section, it would fall outside the 

definition of an online pharmacy; or 

(11) A covered online telemedicine 

platform as defined in this section. 

Palliative care means patient and 

family-centered care that optimizes 

quality of life by anticipating, 

preventing, and treating suffering. 

Palliative care throughout the 

continuum of illness involves 

addressing physical, intellectual, 

emotional, social, and spiritual needs 

and to facilitate patient autonomy, 

access to information, and choice. 

Platform practitioner means a covered 

online telemedicine platform that 

dispenses controlled substances by 

virtue of its central involvement as an 

intermediary in the remote prescribing 

of controlled substances by an 

individual practitioner. Platform 

practitioners are subject to the 

requirements imposed upon nonpharmacist practitioners under the 

Controlled Substances Act, 21 U.S.C. 

801–904, and its regulations. 

Platform special registrant means a 

special registrant issued the 

Telemedicine Platform Registration 

under 1301.11(c)(4) of this chapter. 

Practice of telemedicine means the 

practice of medicine in accordance with 

applicable federal and state laws by a 

practitioner (other than a pharmacist) 

who is at a location remote from the 

patient and is communicating with the 

patient, or health care professional who 

is treating the patient, using a 

telecommunications system defined in 

42 CFR 410.78(a)(3), which practice falls 

within a category listed in paragraphs 

(1) through (7) of this definition: 

(1) Treatment in a hospital or clinic. 

The practice of telemedicine is being 

conducted while the patient is being 

treated by, and physically located in, a 

hospital or clinic registered under 

section 303(f) of the Act (21 U.S.C. 

823(f)) by a practitioner acting in the 

usual course of professional practice, 

who is acting in accordance with 

applicable State law, and who is 

registered under section 303(f) of the 

Act (21 U.S.C. 823(f)) in the State in 

which the patient is located, unless the 

practitioner: 

(i) Is exempted from such registration 

in all States under section 302(d) of the 

Act (21 U.S.C. 822(d); or 

(ii) Is an employee or contractor of the 

Department of Veterans Affairs who is 

acting in the scope of such employment 

or contract, and registered under section 

303(f) of the Act (21 U.S.C. 823(f)) in 

any State or is utilizing the registration 

of a hospital or clinic operated by the 

Department of Veterans Affairs 

registered under section 303(f); 

(2) Treatment in the physical presence 

of a practitioner. The practice of 

telemedicine is being conducted while 

the patient is being treated by, and in 

the physical presence of, a practitioner 

acting in the usual course of 

professional practice, who is acting in 

accordance with applicable State law, 

and who is registered under section 

303(f) of the Act (21 U.S.C. 823(f)) in the 

State in which the patient is located, 

unless the practitioner: 

(i) Is exempted from such registration 

in all States under section 302(d) of the 

Act (21 U.S.C. 822(d)); or 

(ii) Is an employee or contractor of the 

Department of Veterans Affairs who is 

acting in the scope of such employment 

or contract, and registered under section 

303(f) of the Act (21 U.S.C. 823(f)) in 

any State or is using the registration of 

a hospital or clinic operated by the 

Department of Veterans Affairs 

registered under section 303(f); 

(3) Indian Health Service or Tribal 

organization. The practice of 

telemedicine is being conducted by a 

practitioner who is an employee or 

contractor of the Indian Health Service, 

or is working for an Indian Tribe or 

Tribal organization under its contract or 

compact with the Indian Health Service 

under the Indian Self-Determination 

and Education Assistance Act; who is 

acting within the scope of the 

employment, contract, or compact; and 

who is designated as an internet Eligible 

Controlled Substances Provider by the 

Secretary of Health and Human Services 

under section 311(g)(2) of the Act (21 

U.S.C. 831(g)(2)); 


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(4) Public health emergency declared 

by the Secretary of Health and Human 

Services. The practice of telemedicine is 

being conducted during a public health 

emergency declared by the Secretary of 

Health and Human Services under 

section 319 of the Public Health Service 

Act (42 U.S.C. 247d), and involves 

patients located in such areas, and such 

controlled substances, as the Secretary 

of Health and Human Services, with the 

concurrence of the Administrator, 

designates, provided that such 

designation shall not be subject to the 

procedures prescribed by the 

Administrative Procedure Act (5 U.S.C. 

551–559 and 701–706); 

(5) Special registration. The practice 

of telemedicine is being conducted by a 

practitioner who has obtained from the 

Administrator a special registration 

under section 311(h) of the Act (21 

U.S.C. 831(h)); 

(6) Department of Veterans Affairs 

medical emergency. The practice of 

telemedicine is being conducted: 

(i) In a medical emergency situation: 

(A) That prevents the patient from 

being in the physical presence of a 

practitioner registered under section 

303(f) of the Act (21 U.S.C. 823(f)) who 

is an employee or contractor of the 

Veterans Health Administration acting 

in the usual course of business and 

employment and within the scope of the 

official duties or contract of that 

employee or contractor; 

(B) That prevents the patient from 

being physically present at a hospital or 

clinic operated by the Department of 

Veterans Affairs registered under 

section 303(f) of the Act (21 U.S.C. 

823(f)); 

(C) During which the primary care 

practitioner of the patient or a 

practitioner otherwise practicing 

telemedicine within the meaning of this 

paragraph is unable to provide care or 

consultation; and 

(D) That requires immediate 

intervention by a health care 

practitioner using controlled substances 

to prevent what the practitioner 

reasonably believes in good faith will be 

imminent and serious clinical 

consequences, such as further injury or 

death; and 

(ii) By a practitioner that: 

(A) Is an employee or contractor of the 

Veterans Health Administration acting 

within the scope of that employment or 

contract; 

(B) Is registered under section 303(f) 

of the Act (21 U.S.C. 823(f)) in any State 

or is utilizing the registration of a 

hospital or clinic operated by the 

Department of Veterans Affairs 

registered under section 303(f); and 

(C) Issues a controlled substance 

prescription in this emergency context 

that is limited to a maximum of a fiveday supply which may not be extended 

or refilled; or 

(7) Other circumstances specified by 

regulation. The practice of telemedicine 

is being conducted under any other 

circumstances that the Administrator 

and the Secretary of Health and Human 

Services have jointly, by regulation, 

determined to be consistent with 

effective controls against diversion and 

otherwise consistent with the public 

health and safety. 

Refilling prescriptions for controlled 

substances in Schedule III, IV, or V: (1) 

Means the dispensing of a controlled 

substance in Schedule III, IV, or V in 

accordance with refill instructions 

issued by a practitioner as part of a valid 

prescription that meets the requirements 

of subsections (b) and (c) of section 309 

of the Act (21 U.S.C. 829) and 

§§ 1306.21 and 1306.22 of this chapter, 

as appropriate; and 

(2) Does not include the issuance of 

a new prescription to an individual for 

a controlled substance that individual 

was previously prescribed. 

Special registered location means the 

physical address of record for a Special 

Registration for Telemedicine. The 

special registered location shall be the 

same address as one of the special 

registrant’s 1301.13(e)(1)(iv) registered 

locations, unless exempted by 

§ 1301.13(k)(1) of this chapter, in which 

case the special registered location shall 

be the physical address provided on the 

special registrant’s Form 224S. 

Special registrant means a 

practitioner who has been issued a 

Special Registration for Telemedicine 

(either a Telemedicine Prescribing 

Registration, an Advanced Telemedicine 

Prescribing Registration, or a 

Telemedicine Platform Registration). 

Special Registration for Telemedicine 

means a registration issued by the 

Administrator pursuant to section 

311(h) of the Act (21 U.S.C. 831(h)) to 

a practitioner who seeks to engage in the 

practice of telemedicine pursuant to 

section 102(54)(E) of the Act (21 U.S.C. 

802(54)(E)) and 1300.04 of this chapter, 

which may be used to prescribe 

controlled substances by means of the 

internet (within the meaning of section 

102(51) of the Act (21 U.S.C. 802(51)) 

without having first conducted an inperson medical evaluation with patients 

to whom such prescriptions are being 

issued. The three types of Special 

Registration for Telemedicine are the 

Telemedicine Prescribing Registration, 

the Advanced Telemedicine Prescribing 

Registration, and the Telemedicine 

Platform Registration. 

Special registration prescription 

means a prescription, defined under 

§ 1300.01 of this chapter, for controlled 

substances issued under a practitioner’s 

Special Registration for Telemedicine 

for a legitimate medical purpose in the 

usual course of professional practice 

through the utilization of an audiovideo telecommunications system 

defined in this section. A special 

registration prescription is facilitated if: 

(1) The prescription is issued to a 

patient who was introduced to the 

prescribing practitioner through a 

covered platform relationship; or 

(2) A covered online telemedicine 

platform facilitated the telemedicine 

encounter that resulted in the 

prescription, including by providing 

audio-visual communication services. 

State Telemedicine Registration 

means a limited type of 21 U.S.C. 823(g) 

registration authorizing an individual 

special registrant to prescribe special 

registration prescriptions to patients 

located within the state or a platform 

special registrant to dispense Schedule 

II–V controlled substances to patients 

located within the state, as required by 

section 311(h)(1)(B) of the Act (21 

U.S.C. 831(h)(1)(B)). 

Telemedicine Platform Registration 

means a type of Special Registration for 

Telemedicine in which the registered 

covered online telemedicine platform is 

authorized to dispense Schedules II 

through V controlled substances 

through the practice of telemedicine 

under 21 U.S.C. 802(54)(E). 

Telemedicine Prescribing Registration 

means a type of Special Registration for 

Telemedicine in which the registered 

practitioner is authorized to prescribe 

Schedules III through V controlled 

substances through the practice of 

telemedicine under 21 U.S.C. 

802(54)(E). 

Valid prescription means a 

prescription that is issued for a 

legitimate medical purpose in the usual 

course of professional practice by: 

(1) A practitioner who has conducted 

at least one in-person medical 

evaluation of the patient; or 

(2) A covering practitioner. 

(3) The definition of valid 

prescription shall not be construed to 

imply that one in-person medical 

evaluation demonstrates that a 

prescription has been issued for a 

legitimate medical purpose within the 

usual course of professional practice. 

PART 1301—REGISTRATION OF 

MANUFACTURERS, DISTRIBUTORS, 

AND DISPENSERS OF CONTROLLED 

SUBSTANCES 

■ 4. The authority citation for part 1301 

continues to read as follows: 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
6594 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

Authority: 21 U.S.C. 821, 822, 823, 824, 

831, 871(b), 875, 877, 886a, 951, 952, 956, 

957, 958, 965 unless otherwise noted. 

■ 5. In § 1301.11, revise the section 

heading and add paragraphs (c) and (d) 

to read as follows: 

§ 1301.11 Persons required to register; 

requirement of modification of registration 

authorizing activity as an online pharmacy; 

Eligibility Requirements for Special 

Registration for Telemedicine; State 

Telemedicine Registrations. 

* * * * * 

(c) Eligibility for Special Registration 

for Telemedicine. Clinician practitioners 

and covered online telemedicine 

platforms are eligible for the Special 

Registration for Telemedicine under 

§ 1300.04 of this chapter. Clinician 

practitioners are eligible for either the 

Telemedicine Prescribing Registration 

or Advanced Telemedicine Prescribing 

Registration, and platform practitioners 

are eligible for the Telemedicine 

Platform Registration pursuant to 21 

U.S.C. 802(54)(E) and 21 U.S.C. 831(h) 

subject to the following: 

(1) In general. (i) A clinician 

practitioner applicant or a covered 

online telemedicine platform applicant 

shall be required to hold one or more 

registrations under § 1301.13(e)(1)(iv) of 

this chapter in a state in which they are 

licensed, registered, or otherwise 

permitted to prescribe or dispense 

controlled substances through 

telemedicine. Clinician practitioners 

exempted from obtaining a State 

Telemedicine Registration for every 

state in which patients to whom they 

will issue special registration 

prescriptions are located under 

§ 1301.11(d) of this chapter are 

exempted from this requirement. 

(ii) Notwithstanding § 1301.23(a) of 

this chapter, all clinician practitioners 

must apply for and obtain a 

Telemedicine Prescribing Registration 

or Advanced Telemedicine Prescribing 

Registration before issuing special 

registration prescriptions. 

(2) Telemedicine Prescribing 

Registration (Schedules III–V). If the 

condition required in paragraph (c)(1) of 

this section is satisfied, a Practitioner or 

Mid-Level Practitioner, as defined under 

§ 1300.01(b) of this chapter, may have a 

legitimate need under 21 U.S.C. 831(h) 

for the Telemedicine Prescribing 

Registration and may apply for the 

registration to prescribe Schedules III–V 

controlled substances when they 

anticipate that they will be treating 

patients for whom requiring in-person 

medical evaluations could impose 

significant burdens on the patients to 

maintain a bona fide practitioner-patient 

relationships. 

(3) Advanced Telemedicine 

Prescribing Registration (Schedules II– 

V). If the condition required in 

paragraph (c)(1) of this section is 

satisfied, a Practitioner or Mid-Level 

Practitioner may have a legitimate need 

under 21 U.S.C. 831(h) for the 

Advanced Telemedicine Prescribing 

Registration, and may apply for the 

registration to prescribe Schedules II–V 

controlled substances, when they 

anticipate that they will be treating 

patients for whom requiring in-person 

medical evaluations could impose 

significant burdens on the patient to 

maintain bona fide practitioner-patient 

relationships, and the practitioner or 

Mid-Level Practitioner is one or more of 

the following: 

(i) The practitioner is a psychiatrist or 

is board certified in the treatment of 

psychiatric or psychological disorders; 

(ii) The practitioner is a hospice care 

physician or is board certified in 

hospice care; 

(iii) The practitioner is a palliative 

care physician or is board certified in 

palliative care; 

(iv) The practitioner renders treatment 

at one or more long term care facilities; 

(v) The practitioner is a pediatrician 

or is board certified in pediatric care; 

and/or 

(vi) The practitioner is a neurologist 

or is board certified in the treatment of 

neurological disorders unrelated to the 

treatment and management of pain. 

(4) Telemedicine Platform 

Registration (Schedules II–V). A covered 

online telemedicine platform, as defined 

under § 1300.04 of this chapter, may 

have a legitimate need under 21 U.S.C. 

831(h) for the Telemedicine Platform 

Registration, and shall apply for the 

registration to dispense Schedules II–V 

controlled substances, when the covered 

online telemedicine platform: 

(i) Anticipates being compensated for 

introducing or facilitating connections 

between patients seeking remote 

medical consultations and practitioners, 

via an audio-video telecommunications 

system, for the diagnosis of patients and 

the treatment of those patients via 

prescription of controlled substances; 

(ii) Is compliant with federal and state 

regulations; 

(iii) Provides oversight over clinician 

practitioners’ prescribing practices; and 

(iv) Takes measures to prioritize 

patient safety and prevent diversion, 

abuse, or misuse of controlled 

substances. 

(d) State Telemedicine Registrations. 

Practitioners issued any of the three 

types of Special Registration for 

Telemedicine shall obtain a State 

Telemedicine Registration defined 

under § 1300.04 of this chapter, for 

every state in which patients to whom 

special registration prescriptions will be 

issued are located. As a limited type of 

21 U.S.C. 823(g) registration, the 

Administrator shall issue the State 

Telemedicine Registration when it is 

consistent with the public interest 

pursuant 21 U.S.C. 823(g)(1). The 

following clinician practitioners are 

exempted from obtaining a State 

Telemedicine Registration for every 

state: 

(1) Officials of the U.S. Army, Navy, 

Marine Corps, Air Force, Space Force, 

Coast Guard, Public Health Service, or 

Bureau of Prisons who are authorized to 

prescribe via telemedicine in the course 

of their official duties; 

(2) Veterans Health Administration 

(VHA) covered health care professionals 

under 38 U.S.C. 1730C(b), acting within 

the scope of their employment who are 

utilizing the registration of a hospital or 

clinic operated by the VHA registered 

under 21 U.S.C. 823(g) after having 

obtained the approval of the Secretary of 

the Veterans Affairs (VA) to utilize the 

823(g) registration of a VHA-operated 

hospital or clinic; and 

(3) Health care professionals acting 

within the scope of their contract with 

VHA and who have access to, and chart 

patient records within, the VHA’s 

electronic health records, are subject to 

all policies of the VHA, and are utilizing 

the registration of a hospital or clinic 

operated by the VHA registered under 

21 U.S.C. 823(g) after having obtained 

the approval of the Secretary of the 

Veterans Affairs (VA) to utilize the 

823(g) registration of a VA-operated 

hospital or clinic; and 

(4) Any practitioner otherwise 

exempted from registration under 21 

U.S.C. 822(d). 

■ 6. In § 1301.13, add paragraphs 

(e)(1)(xi), (xii), (xiii), (xiv), and (xv), (k), 

(l) to read as follows: 

§ 1301.13 Application for registration; time 

for application; expiration date; registration 

for independent activities; application 

forms, fees, contents and signature; 

coincident activities. 

* * * * * 

(e) * * * 

(1) 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6595 

Business activity Controlled substances DEA application forms 

Application 

fees 

($) 

Registration 

period 

(years) 

Coincident activities 

allowed 

*******

(xi) Telemedicine Prescribing (Special Registration).Schedules III–V .............. New—224S Renewal— 

224S Modification— 

224S(M).

888 3 

(xii) Advanced Telemedicine Prescribing (Special Registration).Schedules II–V ............... New—224S Renewal— 

224S Modification— 

224S(M).

888 3 

(xiii) Telemedicine Platform (Special Registration).Schedules II–V ............... New—224S Renewal— 

224S Modification— 

224S(M).

888 3 

(xiv) State Telemedicine 

for Individual Special 

Registrants (Ancillary 

Registration to a Special Registration).

(Determined by the Special Registration held).New—224S Renewal— 

224S Modification— 

224S(M).

50 3 

(xv) State Telemedicine 

for Platform Special 

Registrants (Ancillary 

Registration to a Special Registration).

(Determined by the Special Registration held).New—224S Renewal— 

224S Modification— 

224S(M).

888 3 

* * * * * 

(k) Special Registration application 

(Form 224S) requirements. Form 224S 

will require the following: 

(1) Special registered location. Special 

Registration applicants shall designate 

one of their existing registered locations 

under paragraph (e)(1)(iv) of this section 

as the registered location/physical 

address of their Special Registration. 

Special Registration applicants that 

would be exempted under § 1301.11(d) 

are exempted from this requirement 

however, such exempted persons shall 

be required to provide another physical 

address. 

(2) Required disclosures and 

attestations. Special Registration 

applicants shall provide the following 

specific disclosures and attestations on 

the Form 224S: 

(i) If the applicant is a platform 

practitioner applying for the 

Telemedicine Platform Registration, it 

shall disclose all employment, 

contractual relationships, or 

professional affiliations with any 

clinician special registrant and Online 

Pharmacy and their respective 

registration numbers. 

(ii) If the applicant is a clinician 

practitioner applying for the 

Telemedicine Prescribing Registration 

or the Advanced Telemedicine 

Prescribing Registration, the applicant 

shall disclose all employment, 

contractual relationships, or 

professional affiliations, including with 

any covered online telemedicine 

platform and the respective covered 

online telemedicine platform’s 

Telemedicine Platform Special 

Registration number, if applicable; and 

the applicant’s practice specialties (e.g., 

hospice care or palliative care); 

(iii) The applicant for a Special 

Registration for Telemedicine, whether 

a clinician practitioner or a covered 

online telemedicine platform, shall 

attest that they have devised and are 

committed to maintaining anti-diversion 

policies and procedures; 

(iv) The applicant for an Advanced 

Telemedicine Prescribing Registration 

shall disclose their practice specialties; 

and 

(v) The applicant for any type of 

Special Registration for Telemedicine 

shall attest that they have a legitimate 

need for a Special Registration for 

Telemedicine and to the facts and 

circumstances that form the basis for 

their legitimate need. 

(3) State Telemedicine Registrationexempted practitioner disclosures. 

Practitioners exempted from State 

Telemedicine Registration under 

§ 1301.11(d) are required to identify all 

the states in which patients will be 

located when being treated via 

telemedicine on the practitioners’ 

registration applications for the 

Telemedicine Prescribing Registration, 

the Advanced Telemedicine Prescribing 

Registration, and the Telemedicine 

Platform Registration. 

(l) Notification of application 

changes; Modifications (Form 224S–M). 

The special registrant shall use Form 

224S–M for the following purposes: 

(1) To promptly notify DEA of any 

changes to the information provided on 

their Special Registration Application 

(Form 224S) within 14 business days on 

the Form 224S–M (e.g., the special 

registrant becomes employed by, 

contracts with, or otherwise 

professionally affiliated with a new 

entity); and 

(2) To make any modifications to their 

Special Registration (e.g., applying for 

additional State Telemedicine 

Registrations to practice telemedicine in 

additional states). 

■ 7. In § 1301.35, revise paragraph (a) 

and add paragraph (d) to read as 

follows: 

§ 1301.35 Certificate of registration; denial 

of registration. 

(a) The Administrator shall issue a 

Certificate of Registration (DEA Form 

223) to an applicant under the 

applicable provisions of sections 

102(54)(E) or 311(h) of the Act (21 

U.S.C. 802(54)(E) and 831(h)) when: 

(1) The applicant for the Special 

Registration for Telemedicine meets the 

eligibility requirements outlined in 

§ 1301.11(c) of this subpart; and 

(2) The Administrator has determined 

that the Special Registration is 

consistent with the public interest 

pursuant to the factors stipulated in 21 

U.S.C. 823(g)(1). 

* * * * * 

(d) The Certificate of Registration 

(DEA Form 223) issued for a Special 

Registration shall contain the following 

information: name; Special Registered 

Location; Special Registration for 

Telemedicine (either a Telemedicine 

Prescribing Registration, Advanced 

Telemedicine Prescribing Registration, 

or Telemedicine Platform Registration), 

and State Telemedicine Registration(s); 


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6596 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

the activity authorized by the Special 

Registration, the Schedules and/or 

Administration Controlled Substances 

Code Number (as set forth in part 1308 

of this chapter) of the controlled 

substances which the registrant is 

authorized to handle; the amount of fee 

paid (or exemption) for each 

registration, and the expiration date of 

each registration. The special registrant 

shall maintain the Certificate of 

Registration at the Special Registered 

Location in a readily retrievable manner 

and shall permit inspection of the 

certificate by any official, agent or 

employee of the Administration or of 

any Federal, State, or local agency 

engaged in enforcement of laws relating 

to controlled substances. 

■ 8. In § 1301.36: 

■ a. Redesignate paragraphs (c) through 

(i) as paragraphs (d) through (j), 

respectively; and 

■ b. Add paragraphs (c) and (k). 

The additions read as follows: 

§ 1301.36 Suspension or revocation of 

registration; suspension of registration 

pending final order; extension of 

registration pending final order. 

* * * * * 

(c) For any registration issued under 

sections 102(54)(E) or 311(h) of the Act 

(21 U.S.C. 802(54)(E) and 831(h)), the 

Administrator may: 

(1) Suspend the registration under the 

grounds stipulated in section 304(a) of 

the Act (21 U.S.C. 824(a)) for any period 

of time; and 

(2) Revoke the registration under the 

grounds stipulated in section 304(a) of 

the Act (21 U.S.C. 824(a)). 

* * * * * 

(k) The suspension or revocation of 

any registration issued under 21 U.S.C. 

823(g) shall result in the automatic 

suspension or revocation of all 

registrations issued under 21 U.S.C. 

831(h), including all Special 

Registrations for Telemedicine and State 

Telemedicine Registrations. 

PART 1304—RECORDS AND 

REPORTS OF REGISTRANTS 

■ 9. The authority citation for part 1304 

continues to read as follows: 

Authority: 21 U.S.C. 821, 827, 831, 871(b), 

958(e)–(g), and 965, unless otherwise noted. 

■ 10. In § 1304.04, add paragraphs (i), 

(j), (k), and (l) to read as follows: 

§ 1304.04 Maintenance of records and 

inventories. 

* * * * * 

(i) For patient verification 

photographic records, an individual 

special registrant, with a Special 

Registration for Telemedicine pursuant 

to 1301.11(c)(2) or (3) of this chapter, or 

a delegated employee or contractor 

under the direct supervision of the 

individual special registrant, shall verify 

the identity of patients prior to issuing 

a special registration prescription via an 

audio-video telecommunications 

system, as defined under § 1300.04 of 

this chapter. At the first telemedicine 

encounter, the individual special 

registrant, or a delegated employee or 

contractor under the direct supervision 

of the individual special registrant, shall 

confirm the identity of the patient, and 

capture a photographic record of the 

patient presenting their federal or stateissued photo identification card or other 

acceptable documents as described in 

paragraph (i)(1) of this section; or verify, 

accept and maintain a copy of the 

patient’s federal or state governmentissued photo identification card or a 

document described in paragraph (i)(1) 

of this section provided by the patient. 

The photographic record shall be 

maintained by the individual special 

registrant and renewed a minimum of 

every two (2) years. After the first 

telemedicine encounter, the individual 

special registrant, or the individual 

special registrant’s delegee, shall 

confirm the patient’s identity against the 

initial or renewed photographic record 

at every telemedicine encounter that 

results in a special telemedicine 

prescription. 

(1) If the individual special registrant 

or a delegated employee or contractor 

under the direct supervision of the 

individual special registrant reasonably 

determines that a patient lacks a federal 

or state-issued photo identification card, 

the individual special registrant or their 

delegee must verify the identity of the 

patients in the manner described in this 

paragraph (i) using other forms of 

documentation to verify the identity of 

the patient, and maintain a 

photographic record of what documents 

were used to verify the patient’s 

identity. 

(2) The photographic records must be 

securely stored within the patient’s 

medical record or chart, separate from 

the special registration prescription data 

reported to DEA under § 1304.60 of this 

subpart to ensure that patient privacy is 

protected. 

(j) For the purpose of maintaining 

special registration telemedicine 

encounter record, every telemedicine 

encounter that results in a special 

registration prescription, the prescribing 

individual special registrant shall 

maintain a record of the date and time 

of the telemedicine encounter, the 

address of the patient during the 

telemedicine encounter, and the home 

address of the patient. The individual 

special registrant must maintain the 

special registration telemedicine 

encounter record for a minimum of two 

(2) years from the date of the 

telemedicine encounter. 

(k) For credential verification and 

conduct-related records, a platform 

special registrant, with a Special 

Registration for Telemedicine pursuant 

to 1301.11(c)(4) of this chapter, shall 

maintain the following records related 

to individual special registrants with 

whom they enter and maintain a 

covered platform relationship: 

(1) Verification of the individual 

practitioner’s credentials, including but 

not limited to records on education, 

training, board or specialty 

certifications; 

(2) The employment contract and any 

other contract between the platform 

practitioner and the individual 

practitioner; and 

(3) Any disciplinary actions or 

sanctions, or documentation of 

complaints, disputes, or incidents 

involving the practice of telemedicine 

engaged in by the individual 

practitioner. The platform practitioner 

must maintain and update the 

credential verification and conductrelated records for a minimum of two (2) 

years. 

(l) For the purpose of maintaining 

centralized recordkeeping at the special 

registered location, a special registrant, 

with a Special Registration for 

Telemedicine pursuant to 1301.11(c)(2)– 

(4) shall maintain all records arising 

from telemedicine encounters at the 

special registrant’s Special Registered 

Location. 

■ 10. Add § 1304.60 under the 

undesignated center heading 

‘‘Prescription Reporting’’ to read as 

follows: 

§ 1304.60 Pharmacy reporting of special 

registration prescription data. 

(a) A pharmacy shall, within seven (7) 

days of the start of every month, report 

aggregate data for the special 

registration prescriptions filled during 

the preceding month for each Schedule 

II controlled substance and each 

Schedule III–V controlled substance 

identified in paragraph (b). For each of 

these controlled substances, the 

pharmacy shall provide the following 

information, organized by the different 

State Telemedicine Registration 

numbers of the individual special 

registrants who prescribed the 

controlled substance, and organized by 

the National Drug Code (NDC) for each 

formulation of the controlled substance 

dispensed: the number of prescriptions 

filled, the volume of the controlled 

substance dispensed, and the number of 


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Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 6597 

patients prescribed the controlled 

substance. If the individual special 

registrant is exempted from State 

Telemedicine Registration under 

§ 1301.11(d) of this chapter, the 

pharmacy shall instead provide the 

Special Registration number for either 

the Telemedicine Prescribing 

Registration or Advanced Telemedicine 

Prescribing Registration of the 

individual special registrant in lieu of a 

State Telemedicine Registration 

number. The pharmacy shall 

electronically report this data through 

DEA Office of Diversion Control’s 

secure network application. 

(b) The Schedule III–V controlled 

substances subject to the reporting 

requirement in paragraph (a) of this 

section are: 

(1) Ketamine, its salts, isomers, and 

salts of isomers (DEA Controlled 

Substances Code Number (CSCN) 7285); 

(2) 2-[(dimethylamino)methyl]-1-(3- 

methoxyphenyl)cyclohexanol, its salts, 

optical and geometric isomers and salts 

of these isomers (including tramadol) 

(CSCN 9752); and 

(3) The following depressants as 

described in 1308.14(c) of this chapter, 

and their salts, isomers, and salt of 

isomers: Alprazolam (CSCN 2882); 

Bromazepam (CSCN 2748); Camazepam 

(CSCN 2749; Chlordiazepxide (CSCN 

2744); Clobazam (CSCN 2751); 

Clonazepam (CSCN 2737); Clorazepate 

(CSCN 2768); Clotiazepam (CSCN 2752); 

Cloxazolam (CSCN 2753); Delorazepam 

(CSCN 2754); Diazepam (CSCN 2765); 

Estazolam (CSCN 2756); Ethyl 

loflazepate (CSCN 2758); Fludiazepam 

(CSCN 2759); Flunitrazepam (CSCN 

2763); Flurazepam (CSCN 2767); 

Halazepam (CSCN 2762); Haloxazolam 

(CSCN 2771); Ketazolam (CSCN 2772); 

Loprazolam (CSCN 2773); Lorazepam 

(CSCN 2885); Lormetazepam (CSCN 

2774); Medazepam (CSCN 2836); 

Midazolam (CSCN 2884); Nimetazepam 

(CSCN 2837); Nitrazepam (CSCN 2834); 

Nordiazepam (CSCN 2838); Oxazepam 

(CSCN 2835); Oxazolam (CSCN 2839); 

Pinazepam (CSCN 2883); Prazepam 

(CSCN 2764); Quazepam (CSCN 2881); 

Remimazolam (CSCN 2846); 

Temazepam (CSCN 2925); Tetrazepam 

(CSCN 2886); and Triazolam (CSCN 

2887). 

■ 12. Add § 1304.61 to read as follows: 

§ 1304.61 Special registrant reporting of 

special registration prescription data. 

A special registrant, either an 

individual special registrant or a 

platform special registrant, shall report 

to DEA on an annual basis within the 

seven (7) days of the start of every year 

the following information for the 

preceding year: the total number of new 

patients in each state where at least one 

special registration prescription for a 

Schedule II controlled substance, or a 

Schedule III–V controlled substance 

identified in § 1304.60(b) has been 

issued; the total number of special 

registration prescriptions for Schedule II 

controlled substances issued by the 

special registrant, in aggregate and 

across all states; and the total number of 

special registration prescriptions for 

Schedule III–V controlled substances 

identified in § 1304.60(b) issued by the 

special registrant, in aggregate and 

across all states. The individual special 

registrant shall electronically report this 

data through DEA Office of Diversion 

Control’s secure network application. 

PART 1306—PRESCRIPTIONS AND 

DISPENSING 

■ 14. The authority citation for part 

1306 continues to read as follows: 

Authority: 21 U.S.C. 821, 829, 831, 871(b), 

unless otherwise noted. 

■ 15. Add an undesignated center 

heading ‘‘Special Registration 

Prescriptions Prescribed by Individual 

Special Registrants’’ and §§ 1306.41 

through 1306.47 to read as follows: 

Special Registration Prescriptions 

Prescribed by Individual Special 

Registrants 

§ 1306.41 Prescription origination within 

the United States. 

The individual special registrant shall 

be physically located within the United 

States when conducting a telemedicine 

encounter and issuing a special 

registration prescription; and have any 

necessary licensure and authorization 

within the U.S. state or territory where 

the practitioner is located when the 

telemedicine encounter takes place. For 

the purposes of this chapter, the United 

States shall mean the 50 states of the 

United States of America, the District of 

Columbia, the Commonwealth of Puerto 

Rico, Guam, the U.S. Virgin Islands, 

America Samoa, Wake Island, Midway 

Islands, Kingman Reef, Johnston Atoll, 

the Northern Mariana Islands, and any 

other trust territory or possession of the 

United States. 

§ 1306.42 Electronic Prescribing for 

Controlled Substances (EPCS) of Special 

Registration Prescriptions. 

The individual special registrant shall 

issue special registration prescriptions 

for controlled substances through 

Electronic Prescribing for Controlled 

Substances (EPCS). 

§ 1306.43 Nationwide Prescription Drug 

Monitoring Program (PDMP) Check 

(a) Effective immediately, on 

[EFFECTIVE DATE OF FINAL RULE], 

prior to issuing a special registration 

prescription for controlled substances, 

including Schedules II through V 

controlled substances, the individual 

special registrant shall perform a check 

of the state Prescription Drug 

Monitoring Program(s) (PDMPS) in: 

(1) The state or territory where the 

patient is located; 

(2) The state or territory where the 

individual special registrant is located; 

and 

(3) Any state or territory with PDMP 

reciprocity agreements with either the 

state or territory where the patient is 

located or the state or territory where 

the individual special registrant is 

located, for data regarding any 

controlled substance prescriptions 

issued to the patient in the last year, or, 

if less than one year of data is available, 

in the entire available period, prior to 

issuing a special registration 

prescription for controlled substances. 

(b) Effective three (3) years from 

[EFFECTIVE DATE OF FINAL RULE], 

the individual special registrant shall 

perform a comprehensive nationwide 

check of all 50 state Prescription Drug 

Monitoring Programs (PDMPs) and 

PDMPs in any U.S. district and territory 

that maintains its own PDMP for data 

regarding any controlled substance 

prescriptions issued to the patient in the 

last year, or, if less than one year of data 

is available, in the entire available 

period, prior to issuing a special 

registration prescription for controlled 

substances. If there is no means to 

perform this comprehensive nationwide 

check three (3) years from [the date of 

the promulgation of the final rule], then 

the individual special registrant shall 

continue to perform the PDMPs checks 

as described in paragraph (a) if this 

section, and special registration 

prescriptions for Schedule II controlled 

substances shall only be issued to 

patients located within the same state as 

the individual special registrant, i.e., 

where there is an intra-state 

practitioner-patient relationship. 

§ 1306.44 Required Use of Audio-Video 

Telecommunication System 

(a) Every special registration 

prescription, as defined in § 1300.04 of 

this chapter, shall be issued through the 

use of an audio-video 

telecommunication system defined in 

§ 1300.04 of this chapter. 

(b) Notwithstanding paragraph (a) of 

this section and § 1300.04 of this 

chapter, special registrants may issue 

special registration prescriptions for 


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6598 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Proposed Rules 

Schedule III–V narcotic controlled 

substances approved by the Food and 

Drug Administration for the treatment of 

Opioid Use Disorder through the use of 

an audio-only telecommunications 

system as described in 42 CFR 

410.78(a)(3), provided that the treatment 

was initiated through the use of an 

audio-video telecommunications system 

as defined in § 1300.04 of this chapter, 

the practitioner has conducted at least 

one medical evaluation of the patient 

through the use of an audio-video 

telecommunication system defined in 

§ 1300.04 of this chapter, and the 

prescription is being issued for the 

treatment of Opioid Use Disorder. 

§ 1306.45 Requirements for Issuing a 

Special Registration Prescription for 

Schedule II Controlled Substances 

(a) A special registration prescription 

may not be issued for a controlled 

substance listed in Schedule II unless 

the individual special registrant has an 

Advanced Telemedicine Prescribing 

Registration and the individual special 

registrant is: a psychiatrist or board 

certified in the treatment of psychiatric 

and psychological disorders, and 

issuing the prescription for the 

treatment of mental health; a hospice 

care physician or board certified in 

hospice care, and issuing the 

prescription for hospice care; a 

palliative care physician or board 

certified in palliative care, and issuing 

the prescription for palliative care; a 

physician rendering treatment to a 

patient who resides and is present in a 

long term care facility at the time the 

prescription is issued; a pediatrician or 

board certified in pediatric care, and is 

issuing the prescription to a patient 

under the age of 18 while the parent or 

guardian of the patient is present in the 

room with the patient at the time the 

prescription is issued; or a neurologist 

or board certified in the treatment of 

neurological disorders unrelated to the 

treatment and management of pain 

(b) A special registration prescription 

may not be issued for a controlled 

substance listed in Schedule II unless 

the individual special registrant is 

physically located in the same state in 

which the patient was located at the 

time of the telemedicine encounter that 

resulted in the issuance of the 

prescription when issuing the 

prescription for the Schedule II 

controlled substance. 

(c) The number of special registration 

prescriptions issued by the individual 

special registrant in a calendar month 

for Schedule II controlled substances 

shall constitute less than 50 percent of 

the total number of Schedule II 

prescriptions issued in that calendar 

month by the individual special 

registrant in their telemedicine and nontelemedicine practice. The average 

number of special registration 

prescriptions shall be calculated from 

the first day of the month through the 

last day of the month. 

§ 1306.46 State Laws Applicable to Special 

Registration Prescriptions 

When issuing a special registration 

prescription, a special registrant must 

comply with the laws and regulations 

of: 

(a) The state in which the special 

registrant is located during the 

telemedicine encounter resulting in the 

special registration prescription; 

(b) The state in which the patient is 

located during the telemedicine 

encounter resulting in the special 

registration prescription; and 

(c) Any state or states in which the 

special registrant maintains a DEA 

registration to dispense controlled 

substances or a medical license, to the 

extent that the law or regulation applies 

to telemedicine encounters between 

practitioners and patients located in the 

states described in paragraphs (a) and 

(b) of this section. 

§ 1306.47 Additional Elements on a 

Special Registration Prescription 

(a) A special registration prescription 

shall contain: the individual special 

registrant’s Special Registration for 

Telemedicine number and State 

Telemedicine Registration number, 

unless exempted from State 

Telemedicine Registration under 

§ 1301.11(d) of this chapter; and, if the 

prescription is facilitated by a platform 

registrant, the covered online 

telemedicine platform’s Special 

Registration for Telemedicine number 

and State Telemedicine Registration 

number. If exempted from State 

Telemedicine Registration, the special 

registrant shall notate on the 

prescription the state in which the 

patient was located at the time of the 

telemedicine encounter that resulted in 

the issuance of the prescription. 

(b) A special registration prescription 

shall contain all the information 

required on a prescription under 

§ 1306.05(a) of this chapter, with the 

exception that the number associated 

with a registration under 

1301.13(e)(1)(iv) of this chapter shall 

not be required. 

(c) A corresponding liability rests 

upon the pharmacist who fills a special 

registration prescription that is not 

prepared in the form required by this 

regulation. 

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 

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. 

[FR Doc. 2025–01099 Filed 1–15–25; 8:45 am] 

BILLING CODE 4410–09–P 


KHAMMOND on DSK9W7S144PROD with PROPOSALS2