Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation, 12875-12890 [2023-04248]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Proposed Rules]
[Pages 12875-12890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04248]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1304, and 1306

[Docket No. DEA-407]
RIN 1117-AB40


Telemedicine Prescribing of Controlled Substances When the 
Practitioner and the Patient Have Not Had a Prior In-Person Medical 
Evaluation

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: Under the Ryan Haight Online Pharmacy Consumer Protection Act 
of 2008 and Drug Enforcement Administration's (DEA) implementing 
regulations, after a patient and a practitioner have had an in-person 
medical evaluation, that practitioner may use telehealth to prescribe 
that patient any prescription for a controlled medication that the 
practitioner deems medically necessary. The Ryan Haight Act and DEA's 
implementing regulations do not apply to other forms of telemedicine, 
telehealth, or telepsychiatry that are not otherwise addressed in the 
Controlled Substances Act. This proposed rule applies only in limited 
circumstances when the prescribing practitioner wishes to prescribe 
controlled medications via the practice of telemedicine and has not 
otherwise conducted an in-person medical evaluation prior to the 
issuance of the prescription.

DATES: Electronic comments must be submitted, and written comments must 
be postmarked, on or before March 31, 2023. 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 on or before March 31, 2023.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-407'' on all correspondence, including any 
attachments.
    Electronic Comments: The Drug Enforcement Administration encourages 
that all comments be submitted through the Federal eRulemaking Portal, 
which provides the ability to type short comments directly into the 
comment field on the web page or to attach a file for lengthier 
comments. Please go to https://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. Please be aware that submitted comments are 
not instantaneously available for public view on 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 an electronic 
submission are not necessary and are discouraged. Should you wish to 
mail a paper comment in lieu of an electronic comment, it should be 
sent via regular or express mail to: Drug Enforcement Administration, 
Attention: DEA Federal Register Representative/DPW, 8701 Morrissette 
Drive, Springfield, Virginia 22152.
    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, Office 
of Management and Budget, 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: Scott A. Brinks, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, VA 22152, Telephone: (571) 776-3882.

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments

    Please note that all comments received, including attachments and 
other supporting materials, are considered part of the public record. 
They will be made available by the Drug Enforcement Administration 
(``DEA'') for public inspection online at https://www.regulations.gov/. 
The Freedom of Information Act applies to all comments received. 
Confidential information or personal identifying information, 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 https://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.

I. Executive Summary

    The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 
(``Ryan Haight Act'') \1\ amended the Controlled Substances Act 
(``CSA'') in part by adding several new provisions to prevent the 
illegal distribution and dispensing of controlled substances by means 
of the internet. While the Ryan Haight Act amended the CSA to generally 
require that the dispensing of controlled substances by means of the 
internet be predicated on a valid prescription involving at least one 
in-person medical evaluation, it also established seven distinct 
categories \2\ of telemedicine pursuant to which a practitioner may 
prescribe controlled medications for a patient despite never having 
evaluated that patient in person, provided that, among other things, 
such practice is in accordance with applicable Federal and State 
laws.\3\ Notably, the Ryan Haight Act does not limit a practitioner's 
ability to prescribe controlled medications for a patient after there 
has been at least one in-person medical evaluation. This

[[Page 12876]]

rulemaking would authorize telemedicine pursuant to 21 U.S.C. 
802(54)(G) in those instances where (1) the prescribing practitioner 
has not conducted an in-person medical evaluation with the patient; (2) 
the prescription was issued pursuant to a telemedicine encounter and 
(3) the telemedicine encounter results in a prescription for controlled 
medications. The regulatory requirements proposed in this rulemaking 
would only apply to practitioners who issue prescriptions pursuant to 
telemedicine encounters authorized under 802(54)(G). These regulatory 
requirements would not apply to telemedicine practiced pursuant to (A)-
(F). Similarly, as described below, the Ryan Haight Act and DEA's 
implementing regulations do not apply to other forms of telemedicine, 
telehealth, or telepsychiatry that are not otherwise defined in the 
CSA.
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    \1\ Public Law 110-425 (2008). Because the Ryan Haight Act 
amended the CSA, references in this document will generally be to 
the CSA, except where additional specificity will improve clarity.
    \2\ The seven categories are: (1) Treatment in a hospital or 
clinic; (2) Treatment in the physical presence of a DEA-registered 
practitioner; (3) Treatment by Indian Health Service or Tribal 
practitioners; (4) Treatment during a public health emergency as 
declared by the Secretary of Health and Human Services; (5) 
Treatment by a practitioner who has obtained a ``special 
registration''; (6) Treatment by Department of Veterans Affairs 
practitioners during a medical emergency; and (7) Other 
circumstances specified by regulation. 21 CFR 1300.04(i)(1)-(7).
    \3\ 21 U.S.C. 802(54)(A)-(G).
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    The Ryan Haight Act intended to address the threat to public health 
and safety caused by physicians who prescribed controlled medications 
via the internet without establishing a valid doctor-patient 
relationship through such fundamental steps as performing an in-person 
medical evaluation of a patient. Prior to the enactment of the Ryan 
Haight Act, the internet was being exploited to facilitate the unlawful 
distribution of controlled substances through rogue websites. These 
rogue websites fueled the misuse of controlled prescription 
medications, such as hydrocodone and oxycodone, thereby contributing to 
increased drug poisonings and other harmful health, social, and 
economic consequences.
    The Ryan Haight Act was named for a California high school student 
who died in 2001 from a drug poisoning resulting from a controlled 
prescription medication he obtained from a rogue online pharmacy. That 
rogue online pharmacy allowed customers, like Ryan and others, to 
obtain controlled medications without an in-person medical evaluation 
by the prescriber. In Ryan's case, and in many others, the ``[e]ase of 
access to the internet, combined with lack of medical supervision, . . 
. led to tragic consequences in the online purchase of prescriptions 
for controlled substances.'' \4\
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    \4\ S. Rep. No. 110-521, at 5 (2008).
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    The Ryan Haight Act also authorizes the Administrator, in 
conjunction with the Secretary of Health and Human Services 
(``Secretary''), to promulgate rules that would allow practitioners to 
treat patients via telemedicine without having had an in-person 
evaluation in certain circumstances, including where such telemedicine 
practice is in accordance with applicable Federal and State laws, uses 
an approved telecommunications system, and is ``conducted under . . . 
circumstances that the Attorney General and the Secretary have jointly, 
by regulation, determined to be consistent with effective controls 
against diversion and otherwise consistent with the public health and 
safety.'' \5\ Pursuant to this authority, and in concert with the 
Department of Health and Human Services (``HHS''), DEA and HHS are 
hereby proposing to amend 21 CFR parts 1300, 1304, and 1306 to specify 
the circumstances under which practitioners may prescribe controlled 
medications, pursuant to 21 U.S.C. 802(54)(G), to patients whom the 
practitioner has never evaluated in person, including that (1) such 
prescriptions be in accordance with applicable Federal and State \6\ 
laws; and (2) such practitioners possess an active DEA dispensing 
registration issued pursuant to 21 CFR 1301.13(e)(1)(iv) in the State 
in which the practitioner is located (unless exempted).
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    \5\ 21 U.S.C. 802(54)(G).
    \6\ Under the CSA, ``State'' means ``a State of the United 
States, the District of Columbia, and any commonwealth, territory, 
or possession of the United States.'' 21 U.S.C. 802(26).
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    DEA proposes to require practitioners to keep detailed records 
regarding prescriptions issued as a result of a telemedicine encounter 
at the registered location of their 21 CFR 1301.13(e)(1)(iv) 
registration, in digital or paper form that is readily accessible.\7\ 
Under the proposed rule, a prescribing practitioner must include a 
notation on the face of the prescription, or within the prescription 
order if prescribed electronically, that the prescription has been 
issued via a telemedicine encounter.\8\
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    \7\ Proposed 21 CFR 1304.04(i).
    \8\ Proposed 21 CFR 1306.05(i).
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    The proposed rule allows for the prescription of non-narcotic \9\ 
schedule III-V controlled medications when certain circumstances are 
met. For example, the proposed rule allows for the prescribing of 
schedule III-V non-narcotic controlled medications when a practitioner, 
prior to issuing a prescription, reviews recent prescription drug 
monitoring program (``PDMP'') data, i.e., data made available by the 
State in which the patient is located, regarding controlled medication 
prescriptions issued to the patient in the last year or, if less than a 
year of data is available, the entire available period.\10\
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    \9\ Under the CSA, narcotic drugs are drugs that contain 
opiates, cocaine, or ecgonine, as well as certain related plant 
material. 21 U.S.C. 802(17). This definition includes buprenorphine, 
a narcotic drug that has been approved by the FDA for maintenance 
and detoxification treatment of opioid use disorder.
    \10\ Proposed 21 CFR 1306.31(e)(1).
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    Though excluded from the provisions of this proposed rule that 
relate to the prescribing of non-narcotic schedule III-V controlled 
medications, the prescribing of certain narcotic medications such as 
buprenorphine via telemedicine for the treatment of opioid use disorder 
is the subject of another notice of proposed rulemaking titled 
``Expansion of induction of buprenorphine via telemedicine encounter'' 
(RIN 1117-AB78), published elsewhere in this issue of the Federal 
Register, that would expand the circumstances under which the induction 
of buprenorphine for ``maintenance treatment'' \11\ and 
``detoxification treatment'' \12\ of opioid use disorder via 
telemedicine can occur.
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    \11\ 21 U.S.C. 802(29).
    \12\ 21 U.S.C. 802(30).
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    Additionally, the proposed rule generally would subject a 
practitioner practicing telemedicine to initially limit prescriptions 
for a controlled medication issued to a patient to a 30-day supply. A 
practitioner would be allowed to issue multiple prescriptions for the 
same patient, but would only be allowed to prescribe an amount less 
than or equal to a total quantity of a 30-day supply of the controlled 
medication.\13\ Thereafter, to continue prescribing to that patient, 
within 30 days, the prescribing practitioner would be required to 
examine the patient in person. Alternatively, if the prescribing 
practitioner receives a qualifying telemedicine referral for the 
patient in the manner described herein, the practitioner may rely on 
the referring practitioner's in-person medical evaluation in order to 
prescribe the controlled substance via telemedicine.\14\
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    \13\ Proposed 21 CFR 1306.31(c)(2).
    \14\ Proposed 21 CFR 1300.04(k), 1306.31(d).
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II. Legal Authority and Background

    DEA implements and enforces the CSA and the Controlled Substances 
Import and Export Act, (21 U.S.C. 801-971), as amended. DEA publishes 
the implementing regulations for these statutes in 21 CFR parts 1300 to 
end. These regulations are designed to ensure a sufficient supply of 
controlled substances for medical, scientific, and other legitimate 
purposes, and to deter the diversion of controlled substances for 
illicit purposes.
    As mandated by the CSA, DEA establishes and maintains a closed

[[Page 12877]]

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. ``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.\15\ The CSA further authorizes the Administrator 
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.\16\
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    \15\ 21 U.S.C 802(10).
    \16\ 21 U.S.C. 871(b), 958(f).
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    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. The Ryan 
Haight Act applies only in limited circumstances where the prescribing 
practitioner wishes to prescribe controlled medications via the 
practice of telemedicine and has not otherwise conducted an in-person 
medical evaluation prior to the issuance of the prescription. As 
described below, the Ryan Haight Act and DEA's implementing regulations 
do not apply to other forms of telemedicine, telehealth, or 
telepsychiatry that are not otherwise defined in the CSA.
    As indicated above, in 21 U.S.C. 829(e), the Ryan Haight Act 
generally requires an in-person medical evaluation prior to the 
prescription of controlled substances. Section 829(e), however, also 
provides an exception to this in-person medical evaluation requirement 
where the practitioner is ``engaged in the practice of telemedicine'' 
\17\ within the meaning of the Ryan Haight Act (21 U.S.C. 802(54)). To 
fall within this definition of the ``practice of telemedicine,'' the 
practice first must be ``in accordance with applicable Federal and 
State laws'' and use ``a telecommunications system referred to in [42 
U.S.C. 1395m(m)].'' \18\ Title 42 U.S.C. 1395m(m) references, but does 
not define, such telecommunications systems. The Centers for Medicare & 
Medicaid Services (``CMS''), however, has promulgated regulations for 
the Medicare program implementing those provisions, and those 
regulations do define ``interactive telecommunications system.'' In 
particular, 42 CFR 410.78(a)(3) states: ``Interactive 
telecommunications system means, except as otherwise provided in this 
paragraph, 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.'' \19\
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    \17\ Id. 829(e)(3)(A).
    \18\ Id. 802(54).
    \19\ See infra for discussion of the use of audio-only 
technology in telemedicine under this proposed rule.
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    The CSA and DEA's regulations only define the ``practice of 
telemedicine'' for the purpose of establishing obligations under the 
CSA and DEA regulations. DEA is not attempting to define what 
constitutes appropriate telemedicine in other contexts. Thus, the 
proposed rule would not determine when medications that are not 
controlled may be appropriately prescribed via telemedicine or the 
nature of appropriate remote medical treatment more generally. 
Moreover, as noted, this proposed rule would not create any additional 
regulatory requirements for other categories of telemedicine authorized 
by the CSA under 21 U.S.C. 802(54)(A)-(F). Rather, it would create 
additional circumstances under which the use of telemedicine to 
prescribe controlled substances is authorized by the CSA.
    Again, in the foregoing and other circumstances encompassed by the 
Ryan Haight Act's definition of the ``practice of telemedicine,'' the 
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 when certain safeguards are 
in place to ensure that the practitioner who is engaged in the practice 
of telemedicine is able to conduct or participate in a bona fide 
medical evaluation of the patient at the remote location, and is 
otherwise prescribing for a legitimate medical purpose while acting in 
the usual course of professional practice.
    Accordingly, as set forth in 21 U.S.C. 802(54), the Ryan Haight 
Act's definition of the ``practice of telemedicine'' includes seven 
distinct categories of telemedicine that Congress determined were 
appropriate to allow for the prescribing of controlled substances 
despite the practitioner never having evaluated the patient in 
person.\20\ For example, to fall under the first category of the 
``practice of telemedicine,'' the patient must be physically located in 
a DEA-registered hospital or clinic, and the remote prescribing 
practitioner generally must be properly registered with DEA in the 
State in which the patient is located.\21\ To fall under the second 
category, the patient generally must be being treated by, and in the 
physical presence of, a practitioner who is registered with DEA in the 
State in which the patient is located.\22\
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    \20\ The fifth such category contemplates the prescription of 
controlled substances via telemedicine encounters conducted by 
practitioners to whom the DEA Administrator has issued ``special 
registration[s].'' See 21 U.S.C. 802(54)(E). In the SUPPORT for 
Patients and Communities Act (SUPPORT Act), signed into law on 
October 24, 2018, Congress required DEA to promulgate regulations 
concerning such special registrations. See id. 831(h)(2). This 
instance of rulemaking, which sets forth circumstances under which 
telemedicine encounters may result in the prescription of controlled 
substances without an in-person evaluation and also provides 
safeguards for such prescriptions, is consistent with, and fulfills, 
DEA's obligations under both the Ryan Haight Act and the SUPPORT 
Act.
    \21\ Id. 802(54)(A). If practitioners are exempted from 
registration in all States under DEA regulations or are employees or 
contractors of the VA and meet certain conditions, they do not have 
to be registered.
    \22\ Id. 802(54)(B). If practitioners are exempted from 
registration in all States under DEA regulations or are employees or 
contractors of the VA and meet certain conditions, they do not have 
to be registered.
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    The definition of the ``practice of telemedicine'' also includes as 
one of its seven categories a practice ``being conducted under any 
other circumstances that the Attorney General and the Secretary have 
jointly, by regulation, determined to be consistent with effective 
controls against diversion and otherwise consistent with the public 
health and safety.'' \23\ Pursuant to this authority, DEA and HHS are 
hereby proposing a rule specifying the circumstances under which 
practitioners may prescribe controlled substances to patients whom the 
practitioner has never evaluated in person. This rulemaking would not 
impose any new requirements on practitioners authorized to practice 
telemedicine under other statutory exceptions in 21 U.S.C. 802(54), 
such as Indian Health Service (``IHS'') and Tribal practitioners, who 
are authorized to engage in the practice of telemedicine under a 
different statutory paragraph,

[[Page 12878]]

802(54)(C). The proposed changes to DEA's regulations herein are 
consistent ``with effective controls against diversion and otherwise 
consistent with the public health and safety'' pursuant to 21 U.S.C. 
802(54)(G).
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    \23\ Id. 802(54)(G).
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    DEA is proposing these regulatory changes in concert with HHS, and 
HHS was consulted in the creation of these regulatory provisions and 
concurs with this proposed rulemaking. HHS also has advised DEA that no 
additional rulemaking by HHS is necessary as it pertains to the 
promulgations of these provisions pursuant to 21 U.S.C. 802(54)(G).

III. Section-by-Section Discussion of Proposed Rule

    This proposed rule describes the circumstances under which, 
pursuant to 21 U.S.C. 802(54)(G), a practitioner may prescribe 
controlled substances to patients whom the practitioner has not 
evaluated in person.

A. Part 1300: Definitions

    In section 21 CFR 1300.04, DEA is proposing to add definitions for 
the following terms: practice of telemedicine; qualifying telemedicine 
referral; telemedicine encounter; telemedicine prescription; and 
telemedicine relationship established during the COVID-19 public health 
emergency. In addition, DEA proposes to amend its regulations to 
clarify one aspect of the definition of the practice of telemedicine, 
and to remove an expired paragraph that provided a temporary definition 
of the practice of telemedicine.
    DEA proposes to amend its regulatory definition of the term 
``practice of telemedicine'' to better explain, but not alter, its 
requirements. The current regulatory definition, 21 CFR 1300.04(i), 
follows the Ryan Haight Act's statutory definition, 21 U.S.C. 802(54), 
by requiring that the practice of telemedicine take place ``using a 
telecommunications system referred to in section 1834(m) of the Social 
Security Act (42 U.S.C. 1395m(m)).'' As noted above, 42 U.S.C. 1395m(m) 
references, but does not define, such telecommunications systems. CMS, 
however, has promulgated regulations for the Medicare program 
implementing those provisions that define ``interactive 
telecommunications system,'' 42 CFR 410.78(a)(3), and it is to this CMS 
definition that the Ryan Haight Act and DEA regulatory definitions of 
the ``practice of telemedicine'' ultimately refer.
    The proposed rule would revise the DEA regulatory definition of 
``practice of telemedicine'' \24\ in accordance with this CMS 
regulation to require that telemedicine take place ``using an 
interactive telecommunications system referred to in 42 CFR 
410.78(a)(3).'' This would not be a substantive change to DEA's 
regulations, but merely a clarification of the existing requirements--
updating the language in 21 CFR 1300.04 to save readers from having to 
cross-reference 42 U.S.C. 1395m(m) (and then ascertain what CMS 
regulations implement it) to determine the nature of the 
telecommunications systems that can be used to engage in the practice 
of telemedicine under DEA regulations.
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    \24\ Proposed 21 CFR 1300.04(j).
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    That said, CMS recently revised 42 CFR 410.78(a)(3),\25\ and some 
explanation of revised Sec.  410.78(a)(3)--and its implications for 
this proposed rule--may be useful. Previously, Sec.  410.78(a)(3) had 
limited an ``interactive telecommunications system'' to ``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.'' 
Revised Sec.  410.78(a)(3) retains this requirement of both audio and 
video real-time communication between the patient and the distant 
practitioner in most circumstances: as the CMS rule revising Sec.  
410.78(a)(3) stated, ``[T]wo-way, audio/video communications technology 
is the appropriate, general standard for telehealth services . . . .'' 
\26\
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    \25\ Medicare Program; CY 2022 Payment Policies Under the 
Physician Fee Schedule and Other Changes to Part B Payment Policies; 
Medicare Shared Savings Program Requirements; Provider Enrollment 
Regulation Updates; and Provider and Supplier Prepayment and Post-
Payment Medical Review Requirements (``CMS Rule''), 86 FR 64996, 
65666 (Nov. 19, 2021).
    \26\ Id. at 65060.
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    CMS's revised definition of ``interactive telecommunications 
systems,'' however, now also includes two-way, real-time audio-only 
communication technology under certain limited circumstances, 
limitations that are designed to maintain audio-video equipment as the 
general standard and only authorize audio-only equipment when both 
necessary and appropriate. First, to allow the use of audio-only 
equipment, the medical services at issue must be ``furnished for 
purposes of diagnosis, evaluation, or treatment of a mental health 
disorder.'' CMS recognized that, for many mental health services, 
visualization between the patient and clinician may be less critical to 
provision of the service: ``[M]ental health services are different from 
other services because they principally involve verbal exchanges 
between patient and practitioner.'' \27\
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    \27\ Id. at 65061.
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    CMS also responded to comments requesting that audio-only 
technology be permitted for a broader scope of Medicare telehealth 
services. CMS distinguished ``services furnished for purposes of 
diagnosis, evaluation, or treatment of a mental health disorder'' from 
other services, and specified that the scope of the audio-only policy 
is limited to mental health disorders.\28\ CMS also acknowledged that 
``[T]here may be particular instances where visual cues may help a 
practitioner's ability to assess and treat patients with mental health 
disorders, especially where opioids or mental health medications are 
involved . . . .'' \29\
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    \28\ Id.
    \29\ Id.
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    Second, to allow the use of audio-only equipment, the mental health 
services must be provided ``to a patient in their home.'' CMS reasoned 
that other sites at which a patient generally receives telehealth 
services are ``medical settings that are far more likely to have access 
to reliable broadband internet service. When a patient is located at 
one of these . . . sites, access to care is far less likely to be 
limited by access to broadband that facilitates a video connection. In 
contrast, access to broadband, devices, and user expertise is less 
likely to be available at a patient's home.'' \30\ CMS, however, 
adopted a flexible understanding of ``home'': ``[O]ur definition of 
home can include temporary lodging such as hotels and homeless shelters 
as well as locations a short distance from the [patient's] home'' (if 
the patient, ``for privacy or other personal reasons, chooses to travel 
a short distance ways from the exact home location during a telehealth 
service . . . .'').\31\
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    \30\ Id. at 65060.
    \31\ Id. at 65059.
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    Third, to allow the use of audio-only equipment, the distant site 
physician or practitioner must be ``technically capable'' of meeting 
the usual two-way, audio-video interactive communication standard. And, 
relatedly, the patient must ``not [be] capable of, or . . . not consent 
to, the use of video technology.'' In other words, ``because it is 
generally appropriate to require the use of two-way, real-time audio/
video communications technology,'' \32\ the distant practitioner 
engaging in telehealth must make the option of

[[Page 12879]]

audio-visual communication available to the patient. The audio-only 
option may only be used if the patient ``is unable to use, does not 
wish to use, or does not have access to two-way, audio/video 
technology.'' \33\
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    \32\ Id. at 65062.
    \33\ Id. at 65060.
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    Because the proposed rule's definitions of ``practice of 
telemedicine'' and ``telemedicine encounter'' \34\ are linked to 42 CFR 
410.78(a)(3)'s definition of ``interactive telecommunications system,'' 
they would also incorporate that definition's requirements. 
Accordingly, under most circumstances, a remote practitioner would have 
to be using both audio and video equipment permitting two-way, real-
time interactive communication with a patient to be part of a 
``telemedicine encounter'' in the course of the ``practice of 
telemedicine.'' If that practitioner, however, met all of Sec.  
410.78(a)(3)'s various requirements for using audio-only equipment 
(mental health services, etc.), then that practitioner could engage in 
the ``practice of telemedicine'' and conduct ``telemedicine 
encounters'' as defined in the proposed rule using audio-only 
equipment--so long as that practitioner also complied with the proposed 
rule's other requirements and doing so was medically appropriate and 
also complied with relevant State and Federal law.
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    \34\ Proposed 21 CFR 1300.04().
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    The current regulatory definition of the ``practice of 
telemedicine'' requires that it be conducted ``in accordance with 
applicable Federal and State laws.'' \35\
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    \35\ 21 CFR 1300.04(i). The CSA and DEA's regulations only 
define the ``practice of telemedicine'' for their own purposes. DEA 
is not attempting to define what constitutes appropriate 
telemedicine in other contexts. Thus, the proposed rule would not 
determine when substances that are not controlled may be 
appropriately prescribed via telemedicine or the nature of 
appropriate remote medical treatment more generally. Moreover, the 
proposed rule would not create any additional regulatory 
requirements for the other categories of telemedicine authorized by 
the CSA under 21 U.S.C. 802(54).
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    Proposed paragraph (k) would define what constitutes a ``qualifying 
telemedicine referral'' for the purposes of this rulemaking. This 
definition would clarify the nature of the medical evaluation 
relationship that is required for the referral to enable the 
prescribing practitioner to issue prescriptions in excess of the 30-day 
limit as described in proposed Sec.  1306.31(c)(2). This definition 
would require the referring practitioner to have conducted at least one 
medical evaluation of the patient in the physical presence of the 
referring practitioner, without regard to whether portions of the 
evaluation are conducted by other practitioners. This means that if 
multiple practitioners were physically present during the medical 
evaluation, they would all have the ability to issue a qualifying 
telemedicine referral under this section as long as they otherwise 
complied with DEA regulations. Any other referrals, such as those 
predicated on a telemedicine visit exclusively, would not constitute a 
qualifying telemedicine referral. Both the referring practitioner and 
the prescribing practitioner would be required to maintain records of 
the referral.
    DEA proposes to add paragraph (n) to define the term ``telemedicine 
prescription'' as a prescription issued pursuant to Sec.  1306.31 by a 
physician, or a ``mid-level practitioner'' as defined in 21 CFR 
1300.01(b), engaging in the practice of telemedicine as defined in 21 
CFR 1300.04(j).
    DEA proposes to add paragraph (o) to add a definition of the term 
``telemedicine relationship established during the COVID-19 public 
health emergency.'' Such a relationship exists if the practitioner has 
not conducted an in-person medical evaluation of the patient and has 
prescribed one or more controlled medications based on telemedicine 
encounters during the nationwide public health emergency declared by 
the Secretary of Health and Human Services on January 31, 2020, as a 
result of the Coronavirus Disease 2019 and pursuant to the designation 
pursuant to that public health emergency on March 16, 2020, by the 
Secretary of Health and Human Services, with concurrence of the Acting 
DEA Administrator, that the telemedicine allowance under section 
802(54)(D) applies to all schedule II-V controlled substances in all 
areas of the United States.\36\ Other proposed provisions, discussed in 
detail below, would use this defined term to facilitate a six-month 
transition of doctor-patient relationships from the use of telehealth 
prescribing flexibilities established during the COVID-19 public health 
emergency to the use of the prescribing authority set forth in this 
proposed rule.
---------------------------------------------------------------------------

    \36\ See Xavier Becerra, Renewal of Determination That a Public 
Health Emergency Exists; William T. McDermott, DEA Dear Registrant 
letter, Drug Enforcement Administration (March 25, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf; see 
also Thomas W. Prevoznik, DEA Dear Registrant letter, Drug 
Enforcement Administration (March 31, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Fina
l)%20+Esign.pdf.
---------------------------------------------------------------------------

    Finally, DEA proposes a technical amendment to remove from its 
regulations the ``[t]emporary definition of the practice of 
telemedicine'' found at 21 CFR 1300.04(j).

B. Part 1304: Records of Registrants

    As the Ryan Haight Act recognized, the remote prescribing of 
controlled medications through the internet to patients who have not 
been seen in person by the prescriber presents a heightened risk of 
diversion. Thus, DEA is proposing to amend 21 CFR part 1304 to impose 
certain additional recordkeeping requirements for controlled substance 
prescriptions issued pursuant to telemedicine encounters.\37\ These 
proposed requirements would significantly enhance DEA's ability to both 
detect and investigate the potential misuse of telemedicine to 
prescribe controlled substances for other than legitimate medical 
purposes.
---------------------------------------------------------------------------

    \37\ DEA notes that practitioners who are authorized to engage 
in the practice of telemedicine under other statutory authority in 
21 U.S.C. 802(54), such as IHS practitioners authorized under 21 
U.S.C. 802(54)(C), would not be subject to these proposed additional 
recordkeeping requirements.
---------------------------------------------------------------------------

    In particular, proposed Sec.  1304.03(i) would require a 
practitioner to maintain a written or electronic log for each 
prescription issued pursuant to a telemedicine encounter indicating the 
date the prescription was issued; the full name and address of the 
patient; the drug name, strength, dosage form, quantity prescribed, and 
directions for use; the address at which the practitioner, and the city 
and State in which the patient, is located during the telemedicine 
encounter; if issued through a qualifying telemedicine referral, the 
name and National Provider Identifier (``NPI'') of the referring 
practitioner, a copy of the referral and any communications shared 
pursuant to Sec.  1306.31(d)(3)(i)-(iii); and all efforts to comply to 
access the PDMP system (and, if employed by the Department of Veterans 
Affairs, Department of Veterans Affairs internal prescription 
database). Proposed Sec.  1304.03(j) would require practitioners to 
maintain copies of all qualifying telemedicine referrals they issue.
    Proposed Sec.  1304.03(k) would set requirements for maintaining 
records related to medical evaluations conducted by a prescribing 
practitioner with the patient and another DEA practitioner physically 
together at the other end of an audio-video link pursuant to Sec.  
1306.31(d)(2). Paragraph (1) would require an individual practitioner 
who participates in such a medical evaluation as the prescribing 
practitioner to maintain, for each such medical evaluation, the data 
and time of

[[Page 12880]]

the evaluation; the NPI of the DEA-registered healthcare worker 
physically present with the patient; the address at which the 
prescribing practitioner is located during the telemedicine encounter; 
and the address at which the DEA-registered healthcare worker is 
physically present with the patient during the medical evaluation. 
Likewise, paragraph (2) requires an individual practitioner who 
participates in such a medical evaluation as the DEA-registered 
healthcare worker physically present with the patient to maintain, for 
each such medical evaluation, the data and time of the evaluation; the 
address at which the prescribing practitioner is located during the 
telemedicine encounter; the NPI of the prescribing practitioner; and 
the address at which the DEA-registered healthcare worker is physically 
present with the patient during the medical evaluation.
    Proposed 1304.04(i) would require all such records to be maintained 
at the registered location of the practitioner's 21 CFR 
1301.13(e)(1)(iv) dispensing registration. Put differently, a 
practitioner using telemedicine to prescribe controlled medications may 
operate out of multiple locations. Thus, to avoid any confusion and 
ensure that DEA investigators are able to locate the records when 
necessary, proposed Sec.  1304.04(i) would specify that the required 
records must be maintained at the registered location of the 
practitioner's registration under 21 CFR 1301.13(e)(1)(iv) in digital 
or paper form that is readily accessible.
    If DEA instead were to require records to be maintained in the 
State(s) where telemedicine patients are located, practitioners could 
theoretically have to maintain telemedicine records in over 50 
different locations (if they had a nationwide practice), including 
states in which they may not retain a physical office location. This 
would be burdensome for both the practitioner and DEA investigators. In 
particular, the consolidation of the records under this provision is 
necessary for DEA investigators because the detection of patterns of 
diversion is often contingent upon looking comprehensively at a 
practitioner's prescribing habits and recordkeeping. This process would 
become impracticable if investigators had to obtain records from 50 
different locations across the country, resulting in significant 
administrative waste. Ensuring ready access to this information in a 
consolidated manner in a central location during investigations would 
facilitate DEA's ability to detect patterns of potential illegitimate 
prescribing and thus enhance its ability to prevent further diversion 
of controlled medications. Practically, DEA does not anticipate that 
the consolidation of the records would be overly burdensome for 
practitioners as the majority of practitioners now maintain electronic 
records.
    Requiring this recordkeeping would also serve to reinforce the 
obligation of practitioners who practice telemedicine to prescribe 
within the limited circumstances set forth in the proposed rule. 
Moreover, medical records that include the name of any DEA-registered 
healthcare worker in the physical presence of the patient during a 
telemedicine encounter would be an important tool in subsequent 
investigations as that information is often not otherwise recorded by 
the prescribing practitioner. Requiring the NPI would ensure physically 
present DEA-registered healthcare workers are properly identified, as 
many States may have several practitioners with the same name. 
Investigations can often occur years after the telemedicine encounter, 
and these recordkeeping provisions would reduce the risk of 
investigators missing crucial information because of fading memories or 
faulty/incomplete records.

C. Part 1306: Prescriptions

    DEA proposes to amend part 1306 by adding Sec.  1306.05(i), which 
would require all telemedicine prescriptions issued pursuant to Sec.  
1306.31 to include on the face of the prescription, or within the 
prescription order if prescribed electronically, that the prescription 
was issued via a telemedicine encounter.
    The proposed rule would also amend part 1306 by adding Sec.  
1306.31, which would provide a number of requirements that a 
practitioner would have to satisfy to issue a prescription for a 
controlled substance as a result of a telemedicine encounter. 
Consistent with the text of the Ryan Haight Act and other parts of the 
CSA, controlled substances only may be prescribed for legitimate 
medical purposes by practitioners acting in the usual course of 
professional practice. Proposed Sec.  1306.31(a)(1) is one way the 
proposed rule fulfills that mandate.
    First, proposed Sec.  1306.31(a)(1) would make clear that 
telemedicine may only be used to issue a prescription if that 
prescription is issued pursuant to a telemedicine encounter and is 
issued for a legitimate medical purpose by a practitioner acting in the 
usual course of professional practice. As discussed above, the proposed 
rule would define ``telemedicine encounter'' as a communication between 
a practitioner and a patient using an interactive telecommunications 
system referred to in 42 CFR 410.78(a)(3), while the practitioner is 
engaged in the practice of medicine as defined in proposed Sec.  
1300.04(j).\38\ Thus, under proposed Sec.  1306.31(a)(1), for a 
prescription to be issued to a patient using telemedicine, among other 
things, the prescription would need to arise out of a telemedicine 
communication directly between the prescribing practitioner and that 
patient.\39\
---------------------------------------------------------------------------

    \38\ Proposed 1300.04(o).
    \39\ Proposed 1306.31(a)(6) also broadly requires that a 
practitioner comply with the requirements of State law when 
prescribing pursuant to a telemedicine encounter.
---------------------------------------------------------------------------

    Proposed Sec.  1306.31(a)(2) would require all practitioners who 
wish to engage in the practice of telemedicine to be located in a 
State, Territory, or possession of the United States; the District of 
Columbia; or the Commonwealth of Puerto Rico at the time the relevant 
telemedicine encounter occurs. In other words, a practitioner cannot 
use telemedicine to prescribe controlled medications while that 
practitioner is located outside the United States.
    Proposed Sec.  1306.31(a)(3)(i) would require that a practitioner 
using telemedicine to prescribe a controlled substance be authorized to 
prescribe that basic class of controlled substance under registrations 
in the State where the practitioner is located, as well as the State 
where the patient is located.
    Proposed Sec.  1306.31(a)(4), like proposed Sec.  1306.05(i) 
described above, would require the practitioner to include on a 
prescription issued pursuant to a telemedicine encounter that the 
prescription has been issued based on a telemedicine encounter. Thus, 
when reviewing pharmacy prescription records, DEA investigators could 
readily distinguish prescriptions issued pursuant to telemedicine 
encounters from those issued using their dispensing registrations for 
non-telemedicine prescriptions--giving investigators greater ability to 
detect abusive patterns in the use of telemedicine.
    As discussed above, and as stated in proposed Sec.  
1306.31(c)(1)(i), the proposed rule would only authorize practitioners 
to use telemedicine to prescribe non-narcotic controlled substances in 
schedules III-V. Excluding schedule II controlled substances and all 
narcotic controlled substances \40\ is consistent with the limitations 
Congress placed on the use

[[Page 12881]]

of telemedicine. Congress directed DEA and HHS to authorize the use of 
telemedicine only when doing so is ``consistent with effective controls 
against diversion and otherwise consistent with the public health and 
safety'' 21 U.S.C. 802(54)(G), but permitted DEA and HHS to determine 
the precise circumstances that were most appropriate. Given the ongoing 
opioid epidemic at the time of publishing, DEA believes that allowing 
for the prescription of any schedule II substances or the general 
prescription of narcotic controlled substances \41\ as a result of 
telemedicine encounters would pose too great a risk to the public 
health and safety. However, if the prescribing practitioner has 
received a qualifying telemedicine referral under proposed Sec.  
1300.04(k) for that patient from a referring practitioner who has 
conducted a medical evaluation as described in paragraph proposed Sec.  
1306.31(d)(3), the prescription may be issued for any controlled 
substance that they are otherwise authorized to prescribe under 
applicable laws and regulations.
---------------------------------------------------------------------------

    \40\ As noted above, DEA is addressing the prescribing of 
certain narcotic substances via telemedicine for the treatment of 
opioid use disorder in a separate rulemaking.
    \41\ As noted above, DEA is addressing the prescribing of 
certain narcotic substances via telemedicine for the treatment of 
opioid use disorder in a separate rulemaking.
---------------------------------------------------------------------------

    Proposed Sec.  1306.31(c)(2) would also combat diversion by 
requiring that the prescribing of controlled substances as a result of 
a telemedicine encounter be initially time-limited for each patient 
(unless conducted by VA practitioners). Practitioners could prescribe 
controlled medications to a patient using telemedicine only for a 
period of 30 days before a medical evaluation of the nature described 
below would be required, starting from the date of issuance of the 
first prescription pursuant to a telemedicine encounter. The 
prescribing practitioner would be permitted to issue multiple 
prescriptions for the patient, provided, however, that the 
prescriptions do not authorize the dispensing of more than a total 
quantity of a 30-day supply of the controlled medication. Once that 
prescribing period ends, if the patient does not receive a medical 
evaluation as described below, the practitioner would no longer be able 
to prescribe any controlled medication to that patient as a result of a 
telemedicine encounter until the medical evaluation has taken place.
    To continue prescribing beyond the 30-day window, the prescribing 
practitioner would have to either see the patient for an in-person 
medical evaluation provided in Sec.  1306.31(d)(1)--removing the 
prescription from the bounds of the Ryan Haight Act's telemedicine 
restrictions--or receive a medical evaluation under one of the schemes 
provided in Sec.  1306.31(d)(2) and (d)(3). Under the scheme provided 
in (d)(2), the patient would not be in the physical presence of the 
prescribing practitioner, but the patient would have to be being 
treated by, and in the physical presence of, another DEA-registered 
practitioner. This other non-prescribing practitioner would have to be 
acting in the usual course of professional practice. Also, the 
prescribing practitioner, the DEA-registered practitioner on site with 
the patient, and the patient would have to participate in an audio-
video conference simultaneously (i.e., these individuals must 
participate in a two-way, simultaneous interactive communication with 
both audio and video for this medical evaluation even if audio-only 
communication had been authorized under the standard of 42 CFR 
410.78(a)(3) for prior communications between the prescribing 
practitioner and the patient). Thus, even though the prescribing 
practitioner would not be conducting an in-person evaluation 
themselves, they could rely on the in-person evaluation of the on-site 
practitioner--and remotely observe this evaluation via video and 
audio--when determining whether to continue prescribing to the patient.
    Alternatively, the requirement of a medical evaluation is satisfied 
when the prescribing practitioner receives a qualifying telemedicine 
referral from a DEA registered practitioner under Sec.  1306.31(d)(3). 
Under this scheme, the patient must have received a face-to-face 
evaluation from a DEA registered practitioner, referred to as the 
referring practitioner. The referring practitioner may then issue a 
written qualifying telemedicine referral to the prescribing 
practitioner based on the diagnosis, evaluation, or treatment that was 
provided for the medical issue upon which the medical evaluation was 
predicated pursuant to paragraphs (i) and (iii). Moreover, under 
paragraph (ii), the referring practitioner must communicate the results 
of the medical evaluation which include any diagnosis, evaluation, or 
treatment to the prescribing practitioner, prior to the prescribing 
practitioner issuing a prescription. If the prescribing practitioner 
issues the prescription to the patient prior to receiving the 
information provided in (ii), this does not qualify as a medical 
evaluation for the purposes of Sec.  1306.31(d) and the patient must 
receive a medical evaluation in the manner described in paragraph 
(d)(1) or (d)(2).
    For example, the following scenarios illustrate procedurally how 
this qualifying telemedicine referral would operate:
Example 1
    A patient travels to receive a medical evaluation in the presence 
of their family physician. The physically present practitioner conducts 
a medical evaluation and provides a diagnosis, an evaluation, or 
treatment to the patient. The physically present practitioner 
determines that the patient would benefit from specialized care 
provided by a practitioner across the country (prescribing 
practitioner). The physically present practitioner issues a written 
referral to the prescribing practitioner via an appropriately secured 
electronic communication, and includes in the communication the reason 
for the referral, a copy of the medical record, as well as a 
description of the diagnosis, evaluation, and treatment of the patient 
prior to the prescribing practitioner. The prescribing practitioner 
reviews this information, engages in a telemedicine encounter with the 
patient, and issues a prescription for a controlled medication to the 
patient.
Example 2
    A patient who is insured with, and receives treatment from, a 
medical group (such as Kaiser Permanente) travels to a local medical 
office to receive a medical evaluation in the physical presence of a 
practitioner. The physically present practitioner conducts a medical 
evaluation and provides a diagnosis, an evaluation, or treatment to the 
patient. The physically present practitioner determines that the 
patient would benefit from specialized care provided by a practitioner 
in the same medical group (prescribing practitioner). The physically 
present practitioner issues a written referral to the prescribing 
practitioner via an appropriately secured electronic communication, and 
includes in the communication the reason for the referral, a copy of or 
link to the medical record, as well as a description of the diagnosis, 
evaluation, and treatment of the patient prior to the prescribing 
practitioner. The prescribing practitioner reviews this information, 
engages in a telemedicine encounter with the patient, and issues a 
prescription for a controlled medication to the patient.
    In both examples, the physically present practitioner issued a 
qualifying telemedicine referral to the prescribing

[[Page 12882]]

practitioner. The physically present practitioners issued a written 
referral, based on the medical evaluation that was conducted by the 
physically present practitioner, and shared all pertinent medical 
information as required under proposed Sec.  1306.31(d)(3) with the 
prescribing practitioner. The prescription issued by the prescribing 
practitioner may be for any controlled medication that they are 
otherwise authorized to prescribe under applicable laws and regulations 
under proposed Sec.  1306.31(c)(1). These examples are not intended to 
be exhaustive, and represent only some of the possible scenarios upon 
which a qualifying telemedicine referral may be issued.
    Once a medical evaluation meeting the specified criteria is 
performed, the proposed rule would allow a practitioner to continue 
prescribing a controlled medication to a patient without additional 
evaluations, so long as doing so was consistent with legitimate medical 
purposes and a subsequent evaluation was not required by law.
    Proposed paragraph (e) would require practitioners to review 
available information about past prescriptions to a particular patient. 
Proposed paragraph (e)(1) would require the practitioner, if employed 
by the Department of Veterans Affairs, to review the Department of 
Veterans Affairs' internal prescription database for data regarding any 
controlled medication prescriptions issued to the patient in the last 
year, or, if less than a year of data is available, in the entire 
available period. Proposed paragraph (e)(1) would require all 
practitioners prescribing pursuant to Sec.  1306.31 to review the PDMP 
data for the State in which the patient is located, where available, 
for the last year. PDMPs have proven to be an invaluable tool in 
preventing diversion, allowing practitioners to identity patients whose 
prescription history suggests that they are seeking controlled 
medications for other than legitimate medical needs--either because 
they misuse controlled medications or may be selling them to others. 
Given the heightened risk of diversion in the telemedicine context, DEA 
believes it is appropriate to require practitioners to review PDMP data 
and, for VA practitioners, the VA's own centralized health information 
system, before issuing a telemedicine prescription.
    Proposed paragraph (e)(2)(i) would require, in those circumstances 
where the PDMP system is non-operational, practitioners to limit their 
prescriptions to patients to no more than a 7-day supply until they are 
able to access the PDMP system again. This limit applies until the 
practitioners are able to access the PDMP system, complete their review 
of the patient's prior prescription history, and verify the nature of 
prescriptions when applicable. Paragraph (e)(2)(ii) would require the 
practitioner to gain access to the PDMP system and conduct appropriate 
reviews within 7 days of the telemedicine encounter, and paragraph 
(e)(2)(iii) would require the practitioner to record the attempts to 
access the PDMP and (if applicable) the Department of Veterans Affairs 
internal prescription database pursuant to Sec.  1304.03(i). If the 
practitioner failed to obtain the PDMP (or, if employed by the 
Department of Veterans Affairs, Department of Veterans Affairs internal 
prescription database) data, the dates and times that the practitioner 
attempted to gain access, the reason why the practitioner was unable to 
gain access, and any follow-up attempts made to gain access to the 
system. The 7-day prescription can be refilled upon successful review 
of the PDMP by the practitioner, as long as the prescriptions together 
do not exceed a 30-day supply.
    If the practitioner otherwise completes their review of the PDMP 
system pursuant to paragraph (e)(2)(ii), or is otherwise able to comply 
with all relevant requirements in paragraph (e)(1), proposed paragraph 
(e)(3) would authorize practitioners to prescribe ``no more than a 30-
day supply across all such prescriptions'' until the practitioner has 
conducted the required medical evaluation. Put another way, this 
provision would allow the doctor to provide up to a thirty-day supply 
in any combination of prescriptions and prohibits the doctor from going 
beyond that until the medical evaluation is conducted. This supply may 
include dosages that are titrated up or down depending on the patient's 
response to the medication and the practitioner's medical judgment, 
however, it may not exceed a supply sufficient to treat the patient for 
more than 30 days.
    If the prescribing practitioner does not conduct a medical 
evaluation as described in proposed paragraphs (d)(1) or (d)(2) within 
a period of 30 calendar days, the practitioner would not be authorized 
to issue any subsequent prescriptions to that patient under proposed 
paragraph (f). This requirement would not apply to a practitioner who 
has a telemedicine relationship established during the COVID-19 public 
health emergency with the patient, as defined in Sec.  1300.04(g), or 
to a practitioner employed by the Department of Veterans Affairs when 
prescribing to a patient of the Department of Veterans Affairs health 
system.
    Proposed Sec.  1306.31(g) would require all prescriptions issued as 
a result of telemedicine encounters to be consistent with all other 
requirements of this part. This provision would clarify that unless 
otherwise specified, practitioners authorized to prescribe controlled 
substances in the manner described in this rulemaking would 
nevertheless be subject to the regulatory requirements imposed by Sec.  
1306.31 and DEA registrations generally.

D. Request for Comments

    With respect to the proposed rule, DEA invites comments concerning 
whether any clarifications or other regulatory provisions are warranted 
to ensure appropriate access to care, consistent with effective 
controls against diversion and otherwise consistent with the public 
health and safety. To that end, DEA is requesting comments on whether 
the rule should limit the issuance of prescriptions for controlled 
medications to the FDA-approved indications contained in the FDA-
approved labeling for those medications. DEA invites comments on the 
proposed practitioner recordkeeping obligations. Additionally, based on 
the available information, in order to balance benefits and risks to 
individual and public safety, DEA is proposing a 30-day maximum supply 
under proposed Sec.  1306.31(c)(2) for the controlled substance being 
prescribed via telemedicine prior to an in-person evaluation being 
conducted. DEA seeks comment, including data from research and clinical 
practice, that provides evidence that an alternate maximum day supply 
would be more appropriate than the one proposed in this rulemaking. DEA 
also seeks comments about additional safeguards or flexibilities that 
should be considered with respect to this rule.
    Moreover, DEA invites comments on whether the Notice of Proposed 
Rulemaking, entitled ``Expansion of Induction of Buprenorphine via 
Telemedicine Encounters'' (RIN 1117-AB78), published elsewhere in this 
issue of the Federal Register, should be combined with this rulemaking 
when publishing the Final Rule as both documents refer to prescribing 
via telemedicine pursuant to 21 U.S.C. 802(54)(G).
    This rule is designed to ensure that patients do not experience 
lapses in care. It is also deigned to ensure continuity of care under 
the current telehealth flexibilities in place as a result of the COVID-
19 public health emergency. The COVID-19 public

[[Page 12883]]

health emergency is set to expire on May 11, 2023. DEA and HHS have 
provided for a notice-and-comment period of 30 days so that they have 
an opportunity to fully review and respond to any submissions.

IV. Regulatory Analyses

Executive Orders 12866 (Regulatory Planning and Review), 13563 
(Improving Regulation and Regulatory Review)

    This proposed rule was developed in accordance with the principles 
of Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies 
to assess all costs and benefits of available regulatory alternatives 
and, if regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health, and safety effects; distributive impacts; and equity). 
E.O. 13563 is supplemental to and reaffirms the principles, structures, 
and definitions governing regulatory review established in E.O. 12866. 
E.O. 12866 classifies a ``significant regulatory action,'' requiring 
review by the Office of Management and Budget (``OMB''), as any 
regulatory action that is likely to result in a rule that may: (1) have 
an annual effect on the economy of $100 million or more or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities; (2) 
create a serious inconsistency or otherwise interfere with an action 
taken or planned by another agency; (3) materially alter the budgetary 
impact of entitlements, grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the E.O.
    The economic, interagency, budgetary, legal, and policy 
implications of this proposed rule have been examined, and it has been 
determined that it is a significant regulatory action, but not an 
economically significant regulatory action having an annual effect on 
the economy of $100 million or more, under E.O. 12866. Accordingly, 
this rule has been submitted to the OMB for review.
    DEA expects that this proposed rule would result in a cost savings 
of $3,762,089 per year. Additionally, the proposed rule is estimated to 
decrease transfers to the federal government by $11,628 per year. Fees 
paid to the federal government are considered transfer payments and not 
costs.\42\ The analysis of cost savings, costs, transfers, and benefits 
is provided below.
---------------------------------------------------------------------------

    \42\ OMB Circular A-4.
---------------------------------------------------------------------------

Regulatory Alternatives Considered

    DEA considered four alternatives, including the selected 
alternative: (1) an alternative only allowing the practice of 
telemedicine pursuant to an application and issuance of a ``special 
registration'' allowing such practice; (2) an alternative only allowing 
the practice of telemedicine pursuant to a special registration 
allowing such practice and limiting special registration to the 
prescribing of non-narcotic controlled substances to patients located 
in rural areas, (3) an alternative only allowing the practice of 
telemedicine pursuant to a special registration allowing such practice 
but requiring patients to be located at a qualified originating site, 
and (4) the selected alternative.
    First, DEA considered allowing the practice of telemedicine 
pursuant to an application and issuance of a ``special registration'' 
allowing such practice. Upon further consideration, this alternative 
was deemed potentially burdensome for both prospective telemedicine 
providers and patients. Therefore, DEA decided against this 
alternative.
    Second, DEA considered placing an additional geographic limitation 
on the circumstances under which controlled substances can be 
prescribed pursuant to a special registration for telemedicine. Under 
this alternative, a telemedicine encounter that gives rise to the 
issuance of a prescription under a special registration for 
telemedicine would have to be with a patient in a rural location based 
on the CMS definition of ``rural area'' \43\ (unless the patient is 
being treated by the Department of Veterans Affairs (``VA'')). More 
specifically, under this alternative, prescriptions would have to be 
issued to patients who reside in such ``rural areas.'' Patients 
residing in rural areas were believed to face higher burdens when 
obtaining in-person medical evaluations and thus have a legitimate need 
for increased access to controlled medication prescriptions issued via 
telemedicine. If this alternative were implemented, the patients served 
would be limited to those residing in rural areas. However, upon 
further evaluation of the need for telemedicine and the risk of 
diversion, DEA decided not to propose this ``rural area'' requirement. 
DEA understands patients in non-rural areas can also be underserved and 
have a legitimate need for increased access to prescriptions issued via 
telemedicine. Therefore, DEA decided to include patients in non-rural 
areas in the proposed rulemaking.
---------------------------------------------------------------------------

    \43\ In its regulations, CMS defines a rural area as an area 
located outside an urban area, or a rural census tract within a 
Metropolitan Statistical Area as determined under the most recent 
version of the Goldsmith modification as determined by the Office of 
Rural Health Policy of the Health Resources and Services 
Administration. See 42 CFR 414.605.
---------------------------------------------------------------------------

    Third, DEA considered requiring patients be located at a qualifying 
``originating site'' during the relevant telemedicine encounter. Under 
this alternative, patients (except patients being treated by VA 
practitioners) would be required to be located at one of a defined set 
of ``originating sites'' when receiving treatment leading to a 
controlled substance prescription as a result of a telemedicine 
encounter. CMS regulations at 42 CFR 410.78(b)(3) list twelve types of 
locations described as ``originating sites'' for purposes of Medicare 
Part B payment. DEA considered including a subset of those locations as 
qualifying originating sites for the special registration for 
telemedicine. Specifically, this alternative would include the 
locations listed in section 410.78(b)(3)(i)-(ix): offices of physicians 
or practitioners,\44\ critical access hospitals, rural health clinics, 
federally qualified health centers, hospitals, hospital-based or 
critical access hospital-based renal dialysis centers (including 
satellites), skilled nursing facilities, community mental health 
centers, and renal dialysis facilities.\45\ The intent of this 
alternative was to expand the range of telemedicine treatment that 
practitioners may engage in under the CSA, while also mitigating,

[[Page 12884]]

to the extent practicable, the risk of diversion posed by this 
expansion in controlled substance prescribing. With this in mind, this 
alternative would stipulate that the originating site at which patients 
must be located during treatment must be a clinical setting, be capable 
of handling standard intake processing of patients, and have 
appropriate medical personnel available to provide support to the 
distant prescribing practitioner, as necessary. However, upon further 
consideration, this alternative was deemed too restrictive, with the 
potential of creating a substantial burden on prospective patients. 
Therefore, DEA decided against this alternative.
---------------------------------------------------------------------------

    \44\ The term ``practitioner,'' as used in this section of CMS 
regulations, differs from the definition of that term given in the 
CSA, and includes the following: physicians, physician assistants, 
nurse practitioners, clinical nurse specialists, nurse-midwives, 
clinical psychologists, clinical social workers, registered 
dietitians or nutrition professionals, and certified registered 
nurse anesthetists. 42 CFR 410.78(b)(2). To be clear, under this 
alternative, these are persons whose offices would qualify as 
originating sites for a special registration for telemedicine, but 
not all of these persons would be eligible to obtain and treat 
patients under a special registration for telemedicine.
    \45\ Section 410.78 requires that in addition to qualifying as 
one of these types of facilities, the originating site must meet 
certain geographic requirements over and above the geographic 
restrictions that are part of the definition of some types of 
facilities. This alternative would not require that a facility meet 
these additional geographic requirements in order to qualify as an 
originating site under a special registration for telemedicine, but 
would require that it meet the restrictions imposed in the 
underlying definition of the facility. So, for example, to qualify 
as a rural health clinic and be an originating site for patients 
treated under a special registration for telemedicine, a facility 
would have to meet the requirements of 42 U.S.C. 1395x(aa)(2), but 
not the requirements of 21 CFR 410.78(b)(4).
---------------------------------------------------------------------------

    Finally, DEA is proposing the selected alternative, which would not 
limit prescriptions issued as a result of a telemedicine encounter to 
prescriptions issued pursuant to a special registration regime, to 
patients who reside in ``rural areas,'' or to patients located at a 
qualifying originating site. The selected (proposed) alternative is 
less restrictive and likely to benefit more patients. Below is a 
detailed analysis of the selected alternative.

Analysis of Costs, Cost Savings, Benefits, and Transfers

    There are minimal costs and substantial cost savings, other 
benefits, and transfers associated with this proposed rulemaking. As 
discussed above, this proposed rule describes the circumstances under 
which, pursuant to 21 U.S.C. 802(54)(G), a practitioner may prescribe 
controlled substances to patients whom the practitioner has not 
evaluated in person. This rulemaking would not impose any new 
requirements on practitioners authorized to practice telemedicine under 
other statutory exceptions in 21 U.S.C. 802(54), such as IHS, who are 
authorized to engage in the practice of telemedicine under a different 
statutory paragraph, 802(54)(C).
    Under this proposed rule, practitioners would be allowed to issue 
prescriptions via telemedicine for schedule III-V non-narcotic 
controlled medications to the extent otherwise authorized by their DEA 
registration(s).\46\
---------------------------------------------------------------------------

    \46\ As noted above, DEA is addressing the prescribing of 
certain narcotic substances via telemedicine for the treatment of 
opioid use disorder in a separate rulemaking.
---------------------------------------------------------------------------

    As also discussed earlier, the proposed rule specifies the 
circumstances under which practitioners may prescribe controlled 
substances, pursuant to 21 U.S.C. 802(54)(G), to patients whom the 
practitioner has never evaluated in person, including that:
     Such prescriptions be in accordance with applicable 
Federal and State laws; and
     Such practitioners possess an active DEA dispensing 
registration issued pursuant to 21 CFR 1301.13(e)(1)(iv) in the State 
in which the practitioner is located (unless exempted).
    Consistent with effective controls against diversion and otherwise 
consistent with the public health and safety, the proposed rule also 
specifies requirements related to recordkeeping and prescriptions. DEA 
estimates that there would be no additional infrastructure cost for 
patients or providers associated with this proposed rule, as DEA has 
concluded that most patients and providers already possess or have 
ready access to a telecommunications system meeting the requirements of 
the proposed rule. In addition, there is potential for an added risk of 
diversion from more practitioners having the authority to prescribe 
schedule III-V non-narcotic controlled substances. An analysis of all 
costs is detailed below.
1. Recordkeeping
    This proposed rule would require a practitioner to maintain a 
written or electronic log for each prescription issued pursuant to a 
telemedicine encounter indicating the date the prescription was issued; 
the full name and address of the patient; the drug name, strength, 
dosage form, quantity prescribed, and directions for use; the address 
at which the practitioner, and the city and State in which the patient, 
are located during the telemedicine encounter; if issued through a 
qualifying telemedicine referral, the name and NPI of the referring 
practitioner, a copy of the referral and any communications shared 
pursuant to Sec.  1306.31(d)(3)(i)-(iii); and all efforts to comply to 
access the PDMP system (and, if employed by the Department of Veterans 
Affairs, Department of Veterans Affairs internal prescription 
database).
    DEA believes that these recordkeeping requirements may result in 
additional recordkeeping costs; but, given that the recordkeeping 
required by proposed 21 CFR 1304.03(i) is not extensive and this 
information is expected to be readily available, DEA does not 
anticipate it imposes a major burden on registrants.
2. Prescriptions
    First, this proposed rule would require all prescriptions issued 
pursuant to a telemedicine encounter to note on the face of any 
prescription, or within the prescription order if prescribed 
electronically, issued pursuant to Sec.  1306.31 that the prescription 
was issued via a telemedicine encounter. DEA anticipates any added cost 
associated with this requirement would be minimal, as minimal 
additional time would be required to make this notation.
    Second, as discussed above, this proposed rule would generally 
limit practitioners to use telemedicine to prescribe non-narcotic 
controlled substances in schedules III-V only for a period of 30 days, 
unless such a medical evaluation for the purposes of this section is 
conducted pursuant to Sec.  1306.31 paragraph (d)(1), (d)(2), or 
(d)(3). As DEA is proposing to amend its regulations to specify 
circumstances under which practitioners may prescribe controlled 
substances, pursuant to 21 U.S.C. 802(54)(G), where there is no 
existing regulation, there is no cost associated with this provision.
    Finally, this proposed rule would require all practitioners 
prescribing pursuant to Sec.  1306.31 to review the PDMP data for the 
State in which the patient is located, where available, for the last 
year. DEA estimates many practitioners already check PDMP prior to 
issuing a prescription for a controlled substance for a variety of 
reasons, and therefore, any additional cost is minimal. However, DEA 
welcomes any comment on this estimate, including specific burden 
estimates, if any.
3. Risk of Diversion
    This proposed rulemaking allows practitioners to issue 
prescriptions for schedule III-V non-narcotic controlled substances to 
the extent otherwise authorized by their DEA registration(s).\47\
---------------------------------------------------------------------------

    \47\ As noted above, DEA is addressing the prescribing of 
certain narcotic substances via telemedicine for the treatment of 
opioid use disorder in a separate rulemaking.
---------------------------------------------------------------------------

    Such substances are subject to diversion and misuse, and allowing 
practitioners an increased ability to prescribe these substances via 
telemedicine presents the potential for the increased diversion and 
misuse of these substances. DEA believes that the benefits of increased 
availability for treatment outweigh the dangers of a potential increase 
in diversion--so long as prescribers using telemedicine adhere to the 
safeguards inherent in the requirements of the proposed rule.
4. Other Potential Costs
    DEA also examined the cost of technology for telemedicine, both 
capital investment and operational expenses, in order to use the 
proposed telemedicine authority. DEA believes

[[Page 12885]]

that these initial investments have already been made by the 
practitioners most likely to engage in telemedicine pursuant to 21 
U.S.C. 802(54)(G), and that there would be no additional technology or 
infrastructure cost to these practitioners. For example, VA 
practitioners already make significant use of telehealth services under 
existing authorities. Thus, VA practitioners are already expected to 
have the necessary technology and broadband access in order to 
prescribe controlled medications utilizing telehealth services in a 
manner consistent with the proposed rule. Therefore, DEA believes that 
there are no additional technology or infrastructure costs associated 
with this proposed rulemaking because all stakeholders would be 
leveraging current resources.
5. Summary of Costs
    In summary, DEA estimates any cost associated with this rule is 
minimal.
B. Cost Savings, Transfers, and Benefits
    The following sections summarize the expected cost savings and 
change in transfers related to telemedicine, pursuant to 21 U.S.C. 
802(54)(G), that are realized by both VA and non-VA practitioners.
1. Cost Savings for VA Practitioners
    To quantify the expected cost savings, DEA used data provided by 
the VA regarding the number of VA health care professionals in FY2018 
who have seen a patient via telehealth under existing telemedicine 
authorities, prescribed a controlled medication, and had not completed 
an in-person appointment with that patient. There were 21,046 
encounters identified in FY2018 where a provider prescribed a schedule 
III-V controlled medication via telemedicine without having previously 
completed an in-person appointment under existing CSA telemedicine 
authorities.\48\ These encounters were completed by 1,222 VA health 
care professionals. Because this proposed rule would authorize VA 
providers to prescribe schedule III-V non-narcotic controlled 
substances without requiring the veteran to be physically located in a 
VA clinic, these 21,046 appointments have the potential to be conducted 
in the veteran's home after promulgation of this rule. The VA provided 
DEA with further data on the various cost savings associated with 
conducting these 21,046 appointments via telehealth rather than in a VA 
clinic, including beneficiary travel reimbursement ($143,357); clinic 
staff, space, and equipment cost savings ($6,888,345).\49\ The 
beneficiary travel reimbursement cost saving does not include the 
opportunity cost of the time required to travel to and from 
appointments at a clinic. DEA estimates this cost savings to be 
$492,476 annually.\50\ DEA used these cost savings estimates to 
calculate the impact if 0-100% of those visits were conducted in the 
veteran's home, resulting in a cost savings of between $0 and 
$7,524,178 ($143,357 + $6,888,345 + $492,476) per year. DEA also 
considered whether or not there would be an increase in the number of 
patients that would be treated by VA practitioners pursuant to this 
proposed rule. As mentioned in the economic analysis accompanying the 
VA's 2018 telemedicine preemption rule,\51\ when providers can use more 
of their appointment slots for telehealth care, it expands the 
accessibility of the provider's services without requiring additional 
clinical resources.\52\ Telehealth visits are used in place of in-
person visits but do not, in general, change the number of overall 
visits, supply, or demand. Because DEA does not have a basis to 
determine how many annual clinic appointments would transition to 
telehealth appointments after promulgation of this proposed rule, DEA 
chose to take the mid-point (the scenario in which 50% of the 21,046 
clinic appointments become telehealth visits) of the cost savings 
estimated previously. Therefore, the total annual estimated cost 
savings is $3,762,089.
---------------------------------------------------------------------------

    \48\ There is not a breakdown of whether the prescribed 
scheduled III-V controlled substance was a narcotic or non-narcotic. 
For the purposes of this analysis DEA assumes all 21,046 encounters 
forms the basis for cost savings.
    \49\ VA's Allocation Resource Center and Revenue Operations 
Business Information Office calculated these figures on behalf of 
DEA.
    \50\ DEA used hourly median wage data for All Occupations 
($22.00) to represent the hourly opportunity cost of travel time for 
all patients. Bureau of Labor Statistics, May 2021 National 
Occupational Employment and Wage Estimates, https://www.bls.gov/oes/current/oes_nat.htm (last accessed January 7, 2023). Loaded for 
benefits, the hourly opportunity cost is $31.20 ($22.00 x 1.418). 
Bureau of Labor Statistics, Employer Costs for Employee 
Compensation--September 2022, https://www.bls.gov/news.release/pdf/ecec.pdf (last accessed January 7, 2023). Next, DEA estimated the 
miles travelled per appointment by first dividing the VA-provided 
travel reimbursement cost of $143,357 by the number of appointments 
(21,046), which results in a per-appointment travel reimbursement 
rate of $6.81. To convert the VA's per-appointment reimbursement 
rate into miles driven per appointment, $6.81 is then divided by the 
IRS medical mileage rate of $0.18 (https://www.irs.gov/newsroom/standard-mileage-rates-for-2018-up-from-rates-for-2017), resulting 
in 37.84 miles. DEA conservatively assumes that it would take the 
average patient 45 minutes (0.75 hours) to travel 37.84 miles, 
round-trip. Multiplying the per-hour opportunity cost of $31.20 by 
0.75 results in an opportunity cost of $23.40 per appointment. This 
results in a total opportunity cost savings of $492,476 ($23.40 x 
21,046) for patients.
    \51\ 83 FR 21897 (May 11, 2018).
    \52\ Department of Veterans Affairs, Impact Analysis for RIN 
2900-AQ06 (2018), https://www.regulations.gov/document?D=VA-2017-VHA-0021-0083.
---------------------------------------------------------------------------

2. Transfers for VA Patients
    Transfers borne by VA patients in the form of treatment co-pays are 
expected to be reduced. VA stated that patient co-pays would be reduced 
by $23,255 if the 21,046 appointments were conducted via telehealth 
rather than in VA clinics. Because DEA does not have a basis to 
determine how many annual clinic appointments would transition to 
telehealth appointments after promulgation of this proposed rule, DEA 
chose to take the mid-point (the scenario in which 50% of the 21,046 
clinic appointments become telehealth visits), which results in a 
reduction of transfers from VA patients of $11,628.
3. Benefits of Increased Access to Telemedicine
    Telemedicine has the potential to help address accessibility issues 
and improve access to care, including specialty care, for patients in 
remote and other underserved areas. More than 75 percent of all 
counties in the U.S. are classified as mental health shortage areas, 
and 50 percent do not have any mental health professionals.\53\ The 
need to travel long distances to receive treatment is a common barrier 
to accessibility facing individuals in rural areas without reliable 
transportation options.\54\ As of December 2018, there were 5,124 
designated Mental Health--Health Professional Shortage Areas covering a 
total population of 115,383,074 people.\55\ The greater range of 
telemedicine practice that would be possible under this proposed rule 
would allow practitioners to reach a greater number of patients, 
improving health care outcomes and reducing costs for patients 
throughout the country.
---------------------------------------------------------------------------

    \53\ Substance Abuse and Mental Health Services Administration, 
Rural Behavioral Health: Telehealth Challenges and Opportunities, at 
4 (2016), https://store.samhsa.gov/system/files/sma16-4989.pdf.
    \54\ Id.
    \55\ Health Resources and Services Administration, Designated 
Health Professional Shortage Area Statistics, First Quarter of FY 
2019 Designated HPSA Quarterly Summary (2019), https://ersrs.hrsa.gov/ReportServer?/HGDW_Reports/BCD_HPSA/BCD_HPSA_SCR50_Qtr_Smry_HTML&rc:Toolbar=false.
---------------------------------------------------------------------------

    In addition to the benefits mentioned above, there are many 
benefits specifically for VA patients. A 2018 survey conducted by the 
VA indicated that about 14 percent of veterans with a need for mental 
health services self-reported living more than an hour from

[[Page 12886]]

the nearest VA facility.\56\ Among all the VA users with a need for 
services, 10 percent reported they live more than one hour away from 
the nearest VA facility offering mental health services.\57\ According 
to the survey, living a long distance from a VA facility with mental 
health services significantly decreased the odds of using VA mental 
health care over non-VA mental health care, suggesting that further 
expanding telemedicine options to rural veterans may improve access for 
those who see the distance to the nearest VA mental health facility as 
a barrier to choosing the VA for their care.\58\ Moreover, rural 
veterans with mental health conditions are known to use VA services at 
a lower rate and to have a higher rate of unmet mental health needs 
than veterans living in urban communities.\59\ Increasing access to 
care through telemedicine has the potential to address these issues.
---------------------------------------------------------------------------

    \56\ Department of Veterans Affairs, Z. Joan Wang et al., 2018 
Survey of Veteran Enrollees' Health and Use of Health Care (2019), 
https://www.va.gov/healthpolicyplanning/soe2018/2018enrolleedatafindingsreport_9january2019final508compliant.pdf.
    \57\ Id.
    \58\ Id.
    \59\ Id.
---------------------------------------------------------------------------

4. Summary of Cost Savings and Transfers
    In conclusion, DEA estimates that the annual cost savings of this 
proposed rule is $3,762,089, while annual transfer payments to the 
federal government are decreased by $11,628. It should be noted that 
this estimate of cost savings assumes that the practitioners who engage 
in telemedicine pursuant to 21 U.S.C. 802(54)(G) would adhere to the 
requirements of the proposed rule designed to reduce the risk of 
diversion. If such requirements were not followed, the risk of 
diversion would increase, and any resulting increase in diversion would 
drive up the societal costs associated with the misuse of controlled 
substances.
C. Summary of Economic Impact
    As described above, DEA estimates the total annual cost savings of 
this proposed rule is $3,762,089. Additionally, transfers are estimated 
to decrease by $11,628 annually.

Executive Order 12988, Civil Justice Reform

    The proposed regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice 
Reform, to eliminate ambiguity, minimize litigation, establish clear 
legal standards, and reduce burden.

Executive Order 13132, Federalism

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

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

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

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 would 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 describes the 
circumstances under which, pursuant to 21 U.S.C. 802(54)(G), a 
practitioner may prescribe controlled substances to patients whom the 
practitioner has not evaluated in person.
    A significant number of practitioners, 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 
practitioners that may engage in telemedicine pursuant to this 
regulation. 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'').\60\ The 
following business NAICS codes are estimated to represent businesses 
that employ the affected practitioners:
---------------------------------------------------------------------------

    \60\ SUSB'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 of size standards, effective December 19, 2022. 
https://www.sba.gov/document/support-table-size-standards (last 
visited January 7, 2023). SUSB, 2017 SUSB Annual Data Tables by 
Establishment Industry, Data by Enterprise Receipts Size. https://www.census.gov/data/tables/2017/econ/susb/2017-susb-annual.html. The 
data table is available at https://www2.census.gov/programs-surveys/susb/tables/2017/us_6digitnaics_rcptsize_2017.xlsx (last visited 
January 7, 2023).

 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 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 621112, 621420, and 622210 are annual 
receipts of $13.5 million, $19 million, and $47 million, respectively.
    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 17,480 entities are affected by this proposed 
rule, of which 16,453 (94.1 percent) are small entities. The analysis 
is summarized in table 1 below.

[[Page 12887]]



                             Table 1--Number of Affected Entities and Small Entities
----------------------------------------------------------------------------------------------------------------
                                                                     Number of       SBA size        Number of
                           NAICS Code                                  firms       standard ($)     small firms
----------------------------------------------------------------------------------------------------------------
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             204
                                                                 -----------------------------------------------
    Total.......................................................          17,480  ..............          16,453
    Percent of Total............................................  ..............  ..............            94.1
----------------------------------------------------------------------------------------------------------------

    While this proposed rule may affect a substantial number of small 
entities in the affected industries, as discussed in the E.O. 12866 
section above, DEA estimates that the cost of this rule is minimal for 
all affected entities, including small entities. Therefore, DEA 
concludes the proposed rule would not have a significant economic 
impact on a substantial number of small entities.

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.

Paperwork Reduction Act of 1995

    This proposed rule would impose a new collection 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. The collections of information contained in the 
proposed rule, and identified as such, have been submitted to OMB for 
review under section 3507(d). 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 https://www.reginfo.gov/public/do/PRAMain.

A. Collections of Information Associated With the Proposed Rule

    1. Title: Reporting Requirements for Practitioners Conducting 
Telemedicine.
    OMB control number: 1117-NEW.
    Form numbers: N/A.
    DEA is proposing this rule to describe the circumstances under 
which, pursuant to 21 U.S.C. 802(54)(G), a practitioner may prescribe 
controlled substances to patients whom the practitioner has not 
evaluated in person.
    DEA estimates the following number of respondents and burden 
associated with this collection of information:
     Number of respondents: 31,451.
     Frequency of response: 12 per respondent per year.
     Number of responses: 377,412.
     Burden per response: 0.25 hours (rounded).
     Total annual hour burden: 94,353.

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. 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 shall 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 31, 2023. 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) 362-3261.

List of Subjects

21 CFR Part 1300

    Chemicals, Drug traffic control.

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, 1304, and 1306 as follows:

PART 1300--DEFINITIONS

0
1. The authority citation for part 1300 continues to read as follows:

    Authority: 21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).

0
2. Amend Sec.  1300.04 by:
0
a. Revising the introductory text of paragraph (i).
0
b. Removing and reserving paragraph (j).
0
c. Redesignating paragraphs (k) and (l), as paragraphs (l) and (p).
0
d. Adding paragraphs (k), (m), (n), and (o).
    The revisions and additions read as follows:


Sec.  1300.04  Definitions relating to the dispensing of controlled 
substances by means of the internet.

* * * * *
    (i) The term 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

[[Page 12888]]

communicating with the patient, or health care professional who is 
treating the patient, using an interactive telecommunications system 
referred to in 42 CFR 410.78(a)(3), which practice falls within a 
category listed in paragraphs (i)(1) through (7) of this section:
* * * * *
    (j) [Reserved]
    (k) A qualifying telemedicine referral means a referral to a 
practitioner that is predicated on a medical relationship that exists 
between a referring practitioner and a patient where the referring 
practitioner has conducted at least one medical evaluation in the 
physical presence of the patient, without regard to whether portions of 
the evaluation are conducted by other practitioners, and has made the 
referral for a legitimate medical purpose in the ordinary course of 
their professional practice. A qualifying telemedicine referral must 
note the name and National Provider Identifier of the practitioner to 
whom the patient is being referred.
* * * * *
    (m) The term telemedicine encounter means a communication between a 
practitioner and a patient using an interactive telecommunications 
system referred to in 42 CFR 410.78(a)(3).
    (n) The term telemedicine prescription means a prescription issued 
pursuant to Sec.  1306.31 by a physician, or a ``mid-level 
practitioner'' as defined in Sec.  1300.01(b), engaging in the practice 
of telemedicine as defined in Sec.  1300.04(j).
    (o) An individual practitioner and a patient have a telemedicine 
relationship established during the COVID-19 public health emergency 
if:
    (1) The practitioner has not conducted an in-person medical 
evaluation of the patient;
    (2) The practitioner has prescribed one or more controlled 
substances based on telemedicine encounters during the nationwide 
public health emergency declared by the Secretary of Health and Human 
Services on January 31, 2020, as a result of the Coronavirus Disease 
2019 and pursuant to the designation pursuant to that public health 
emergency on March 16, 2020, by the Secretary of Health and Human 
Services, with concurrence of the Acting DEA Administrator, that the 
telemedicine allowance under section 802(54)(D) applies to all schedule 
II-V controlled substances in all areas of the United States; and
    (3) No more than 180 days have elapsed since [EFFECTIVE DATE OF 
RULE] or the end of the nationwide public health emergency declared by 
the Secretary of Health and Human Services on January 31, 2020, as a 
result of the Coronavirus Disease 2019, whichever is later.
* * * * *

PART 1304--RECORDS AND REPORTS OF REGISTRANTS

0
9. The authority citation for part 1304 continues to read as follows:

    Authority: 21 U.S.C. 821, 827, 871(b), 958(e)-(g), and 965, 
unless otherwise noted.

0
10. In Sec.  1304.03, revise paragraph (c) and add new paragraphs (i), 
(j), and (k), to read as follows:


Sec.  1304.03  Persons required to keep records and file reports.

* * * * *
    (c) Except as provided in paragraph (i) of this section and Sec.  
1304.06, a registered individual practitioner is not required to keep 
records of controlled substances in Schedules II, III, IV, and V that 
are prescribed in the lawful course of professional practice, unless 
such substances are prescribed in the course of maintenance or 
detoxification treatment of an individual.
* * * * *
    (i) An individual practitioner shall maintain, for each 
telemedicine prescription they issue, records indicating the date the 
prescription was issued; the full name and address of the patient; and 
the drug name, strength, dosage form, quantity prescribed, and 
directions for use; the address at which the practitioner, and the city 
and State in which the patient, are located during the telemedicine 
encounter; if issued a qualifying telemedicine referral, the name, and 
National Provider Identifier of the referring practitioner, a copy of 
the referral and any communications shared pursuant to Sec.  
1306.31(d)(3); and all efforts to comply to access the PDMP system 
(and, if employed by the Department of Veterans Affairs, Department of 
Veterans Affairs internal prescription database).
    (j) An individual practitioner shall maintain copies of all 
qualifying telemedicine referrals, as defined in Sec.  1300.04(k), that 
they issue.
    (k)(1) An individual practitioner who participates in a medical 
evaluation conducted pursuant to Sec.  1306.31(d)(2) as the prescribing 
practitioner shall maintain, for each such medical evaluation, the data 
and time of the evaluation; the National Provider Identifier (NPI) of 
the DEA-registered healthcare worker physically present with the 
patient; the address at which the prescribing practitioner is located 
during the telemedicine encounter; and the address at which the DEA-
registered healthcare worker is physically present with the patient 
during the medical evaluation.
    (2) An individual practitioner who participates in a medical 
evaluation conducted pursuant to Sec.  1306.31(d)(2) as the DEA-
registered healthcare worker physically present with the patient shall 
maintain, for each such medical evaluation, the data and time of the 
evaluation; the address at which the prescribing practitioner is 
located during the telemedicine encounter; the National Provider 
Identifier (NPI) of the prescribing practitioner; and the address at 
which the DEA-registered healthcare worker is physically present with 
the patient during the medical evaluation.
* * * * *
0
11. In Sec.  1304.04, add paragraph (i) to read as follows:


Sec.  1304.04  Maintenance of records and inventories.

* * * * *
    (i)(1) An individual practitioner shall maintain all records 
related to telemedicine prescriptions and qualifying telemedicine 
referrals required by this part at the registered location on the 
certificate of registration issued pursuant to section 303(f) of the 
Act (21 U.S.C. 823(g)). If the practitioner holds more than one 
registration issued pursuant to section 303(f) of the Act (21 U.S.C. 
823(g)), the practitioner shall designate the location on one such 
certificate of registration at which to maintain all such records. If 
the individual practitioner is exempt from registration to dispense 
controlled substances pursuant to 21 U.S.C. 822(d), the practitioner 
shall maintain all records related to telemedicine prescriptions and 
qualifying telemedicine referrals required by this part at the location 
where they maintain other records related to controlled substances.
    (2) If a prescribing practitioner conducts an evaluation during 
which the patient is treated by, and in the physical presence of, a 
DEA-registered practitioner (other than the prescribing practitioner) 
pursuant to section 1306.31(d)(2), both the prescribing practitioner 
and the DEA-registered practitioner shall maintain records required by 
this part at the registered location on the practitioners' respective 
certificates of registration issued pursuant to section 303(f) of the 
Act (21 U.S.C. 823(g)).
* * * * *

PART 1306--PRESCRIPTIONS

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


[[Page 12889]]


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

0
13. Amend Sec.  1306.05 by adding paragraph (i), to read as follows.


Sec.  1306.05  Manner of issuance of prescriptions.

* * * * *
    (i) In addition to the requirements of this section, the 
practitioner shall note on the face of any telemedicine prescription, 
or within the prescription order if prescribed electronically, that the 
prescription has been issued based on a telemedicine encounter.
0
14. After Sec.  1306.27, add an undesignated center header and Sec.  
1306.31 to read as follows:
* * * * *

Other Provisions


Sec.  1306.31  Circumstances under which the practice of telemedicine 
may be conducted pursuant to 21 U.S.C. 802(54)(G).

    (a) An individual practitioner may issue telemedicine prescriptions 
if all of the following conditions are met:
    (1) The telemedicine prescription is pursuant to a telemedicine 
encounter and is issued for a legitimate medical purpose by a 
practitioner acting in the usual course of professional practice.
    (2) At the time of the telemedicine encounter that gives rise to 
the issuance of the telemedicine prescription, the practitioner is 
located in a State, Territory, or possession of the United States; the 
District of Columbia; or the Commonwealth of Puerto Rico.
    (3) The practitioner is:
    (i) Authorized under their registration under 21 CFR 
1301.13(e)(1)(iv) to prescribe the basic class of controlled substance 
specified on the prescription; or
    (ii) Exempt from obtaining a registration to dispense controlled 
substances under 21 U.S.C. 822(d).
    (4) The prescription includes the information required by Sec.  
1306.05.
    (b) In addition to the conditions outlined in paragraph (a), 
practitioners are also subject to the limitations in paragraphs (c), 
(d), (e), and (f) of this section when prescribing controlled 
substances pursuant to this section.
    (c) Characteristics of telemedicine prescriptions:
    (1) A telemedicine prescription may only be for a:
    (i) A schedule III, IV, or V non-narcotic controlled substance; or
    (ii) Any controlled substance that the practitioner is otherwise 
authorized to prescribe, provided that one or more of the following 
criteria are met:
    (A) The prescribing practitioner has received a qualifying 
telemedicine referral as defined in Sec.  1300.04(k) for that patient 
from a referring practitioner who has conducted a medical evaluation as 
described in paragraph (d)(3) of this section;
    (B) The prescribing practitioner is employed by the Department of 
Veterans Affairs and the prescription is issued for a patient of the 
Department of Veterans Affairs health system who has received an in-
person medical evaluation from a practitioner who, at the time of the 
examination was employed by the Department of Veterans Affairs; or
    (C) The prescribing practitioner has a telemedicine relationship 
established during the COVID-19 public health emergency with the 
patient, as defined in Sec.  1300.04(o).
    (2) The prescribing practitioner may issue multiple prescriptions 
for the patient, provided, however, that the prescriptions do not 
authorize the dispensing of more than a total quantity of a 30 day 
supply of the controlled substance. This 30-day limitation shall not 
apply to prescriptions issued by a practitioner who has a telemedicine 
relationship established during the COVID-19 public health emergency 
with the patient, as defined in Sec.  1300.04(o), or to a practitioner 
employed by the Department of Veterans Affairs when prescribing to a 
patient of the Department of Veterans Affairs health system who has 
received an in-person medical evaluation from a practitioner who, at 
the time of the examination, was employed by the Department of Veterans 
Affairs. The prescribing practitioner may prescribe a supply in 
addition to the 30 day supply if a medical evaluation is conducted 
pursuant to paragraph (d)(1), (2), or (3) of this section.
    (d) Such a medical evaluation for the purposes of this section may 
be one of the following:
    (1) An evaluation during which the patient is treated by, and in 
the physical presence of, the prescribing practitioner;
    (2) An evaluation during which:
    (i) The patient is treated by, and in the physical presence of, a 
DEA-registered practitioner (other than the prescribing practitioner);
    (ii) This practitioner in the physical presence of the patient is 
acting in the usual course of professional practice;
    (iii) The evaluation is conducted in accordance with applicable 
State law; and
    (iv) The remote prescribing practitioner, the patient, and the DEA-
registered practitioner on site with the patient participate in a real-
time, audio-video conference in which both the practitioners and the 
patient communicate simultaneously.
    (3) An evaluation during which the patient is treated by, and in 
the physical presence of, an individual DEA registered practitioner, or 
individual practitioner exempt from registration under 21 U.S.C. 
822(d), who:
    (i) Issued a written qualifying telemedicine referral as defined in 
Sec.  1300.04(k) for the patient to the prescribing practitioner;
    (ii) Communicated the results of the evaluation by sharing the 
relevant information in the medical record which includes, at a 
minimum, the diagnosis, evaluation, and treatment of the patient prior 
to the prescribing practitioner issuing the prescription; and
    (iii) Has issued the written referral based on the diagnosis, 
evaluation, or treatment that occurred as a result of the medical 
evaluation.
    (e)(1) Prior to issuing the prescription, the practitioner, 
including a practitioner employed by the Department of Veterans 
Affairs, must review and consider the prescription drug monitoring 
program in the State where the patient is located (if the State has 
such a program) 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. The 
practitioner, if employed by the Department of Veterans Affairs, must 
also review the Department of Veterans Affairs internal prescription 
database for data regarding any controlled substance prescriptions 
issued to the patient in the last year, or, if less than a year of data 
is available, in the entire available period.
    (2) If the practitioner is unable to obtain the PDMP (or, if 
employed by the Department of Veterans Affairs, the Department of 
Veterans Affairs internal prescription database) data due to the PDMP 
(or Department of Veterans Affairs internal prescription database) 
system being non-operational or otherwise inaccessible as a result of a 
temporary technological or electrical failure, then:
    (i) The practitioner may issue the prescription for no more than a 
7-day supply;
    (ii) The practitioner must obtain the PDMP (and, if employed by the 
Department of Veterans Affairs, Department of Veterans Affairs internal 
prescription database) data and conduct the review described in 
paragraph (e)(1) of this section within 7 days of the telemedicine 
encounter; and
    (iii) The practitioner must record the attempts to obtain the PDMP 
and (if

[[Page 12890]]

applicable) the Department of Veterans Affairs internal prescription 
database data. If the practitioner fails to obtain the PDMP (or, if 
employed by the Department of Veterans Affairs, Department of Veterans 
Affairs internal prescription database) data as described in paragraph 
(e)(1) of this section, the dates and times that the practitioner 
attempted to gain access, the reason why the practitioner was unable to 
gain access, and any follow-up attempts made to gain access to the 
system.
    (3) Upon completing the review described in paragraph (e)(1) of 
this section, the practitioner may issue prescriptions authorizing the 
dispensing of no more than a 30-day supply across all such 
prescriptions, unless otherwise exempted from the 30-day supply 
limitation.
    (f) If the prescribing practitioner does not conduct a medical 
evaluation meeting the requirements of clause (d)(1), (2), or (3) of 
this section within a period of 30 calendar days of first issuing the 
prescription, the practitioner may not issue any subsequent 
telemedicine prescriptions to that patient until such a medical 
evaluation has been conducted. This restriction shall not apply to a 
practitioner who has a telemedicine relationship established during the 
COVID-19 public health emergency with the patient, as defined in Sec.  
1300.04(o), or to a practitioner employed by the Department of Veterans 
Affairs when prescribing to a patient of the Department of Veterans 
Affairs health system who has received an in-person medical evaluation 
from a practitioner who, at the time of the examination, was employed 
by the Department of Veterans Affairs.
    (g) Except as provided in this section, telemedicine prescriptions 
must be consistent with all other requirements of this part.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
February 24, 2023, 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.

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-04248 Filed 2-27-23; 2:30 pm]
BILLING CODE 4410-09-P