Expansion of Induction of Buprenorphine via Telemedicine Encounter, 12890-12906 [2023-04217]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Proposed Rules]
[Pages 12890-12906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04217]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1304, 1306

[Docket No. DEA-948]
RIN 1117-AB78


Expansion of Induction of Buprenorphine via Telemedicine 
Encounter

AGENCY: Drug Enforcement Administration.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Drug Enforcement Administration (DEA) is amending its 
regulations, in concert with the Department of Health and Human 
Services (HHS), to expand the circumstances under which individual 
practitioners are authorized to prescribe schedule III-V narcotic drugs 
or combinations of such drugs that have been approved for use in 
continuous medical treatment (also referred to as maintenance) or 
withdrawal management treatment (also referred to as detoxification)--
via a telemedicine encounter, including an audio-only telemedicine 
encounter.

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-948'' 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-AB78/Docket 
No. DEA-948.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 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 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

[[Page 12891]]

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.

I. Legal Authority and Background

    An estimated 107,477 fatal drug poisonings occurred between 
September 1, 2021 and August 31, 2022, the majority of which involved 
illegal synthetic drugs. DEA is doing everything in its power to safely 
expand access to treatment to prevent further drug poisoning deaths.
    DEA implements and enforces the Comprehensive Drug Abuse Prevention 
and Control Act of 1970, often referred to as the Controlled Substances 
Act (CSA) and the Controlled Substances Import and Export Act, (21 
U.S.C. 801-971), as amended. DEA publishes the implementing regulations 
for these statutes in 21 CFR parts 1300 to end. These regulations are 
designed to ensure a sufficient supply of controlled substances for 
medical, scientific, and other legitimate purposes, and to deter the 
diversion of controlled substances for illicit purposes.
    As mandated by the CSA, DEA establishes and maintains a closed 
system of control for manufacturing, distribution, and dispensing of 
controlled substances, and requires any person who manufactures, 
distributes, dispenses, imports, exports, or conducts research or 
chemical analysis with controlled substances to register with DEA, 
unless they meet an exemption, pursuant to 21 U.S.C. 822. ``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.\1\ 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.\2\
---------------------------------------------------------------------------

    \1\ 21 U.S.C. 802(10).
    \2\ 21 U.S.C. 871(b), 958(f).
---------------------------------------------------------------------------

    The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 
(The Ryan Haight Act) \3\ 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. 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 of 
telemedicine pursuant to which a practitioner may prescribe controlled 
substances 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.\4\ Notably, the Ryan 
Haight Act does not limit a practitioner's ability to prescribe 
controlled substances for a patient after there has been an in-person 
medical evaluation. In other words, the Ryan Haight Act applies only 
when a prescribing practitioner wishes to prescribe controlled 
substances via the practice of telemedicine and has not otherwise 
conducted an in-person medical evaluation prior to the issuance of the 
prescription. Furthermore, 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.
---------------------------------------------------------------------------

    \3\ Public Law 110-425 (2008). Because the Ryan Haight Act 
amended the CSA, references in this document will generally be to 
the CSA.
    \4\ 21 U.S.C. 802(54)(A)-(G).
---------------------------------------------------------------------------

    The Ryan Haight Act is intended to address the grave threat to 
public health and safety caused by practitioners who prescribed 
controlled substances via the internet without establishing a valid 
practitioner-patient relationship through fundamental steps such 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 legally manufactured controlled 
substances through rogue websites.\5\ These rogue websites facilitated 
the misuse of prescribed controlled substances, such as hydrocodone and 
oxycodone by adolescents and others, and thereby increased the number 
of drug poisonings and other harmful consequences caused by the misuse 
of these substances.\6\
---------------------------------------------------------------------------

    \5\ H.R. REP. 110-869(I), 11, 2008 U.S.C.C.A.N. 2130, 2131.
    \6\ Id.
---------------------------------------------------------------------------

    As indicated above, 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'' \7\ within the meaning of 
the Ryan Haight Act (21 U.S.C. 802(54)). Consistent with the Ryan 
Haight Act's purpose of preventing diversion of controlled substances 
by means of the internet, the Act's definition of ``the practice of 
telemedicine'' does not encompass all forms of telemedicine. Rather, 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.
---------------------------------------------------------------------------

    \7\ Id. 829(e)(3)(A).
---------------------------------------------------------------------------

    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 substances that are not 
controlled may be appropriately prescribed via telemedicine or the 
nature of appropriate remote medical treatment more generally. 
Moreover, 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). Rather, it would create additional 
circumstances under which the use of telemedicine to prescribe 
controlled substances is authorized by the CSA. For example, to fall 
under the last category of telemedicine, the practice is ``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.'' \8\
---------------------------------------------------------------------------

    \8\ Id. 802(54)(G).
---------------------------------------------------------------------------

    As described below, in 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, provided 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

[[Page 12892]]

purpose while acting in the usual course of professional practice.
    To fall within this definition of the ``practice of telemedicine,'' 
the practice also must be ``in accordance with applicable Federal and 
State laws'' and use ``a telecommunications system referred to in [42 
U.S.C. 1395m(m)].'' \9\ Title 42 U.S.C. 1395m(m) references, but does 
not define, such telecommunications systems. The Centers for Medicare & 
Medicaid Services (CMS), however, have promulgated regulations 
implementing those provisions, and those regulations do define 
``interactive telecommunications system.'' \10\ In particular, 42 CFR 
410.78(a)(3) defines an interactive telecommunications system as, in 
pertinent part, multimedia communications equipment that includes, at a 
minimum, audio and video equipment permitting two-way, real-time 
interactive communication between the patient and practitioner. The 
same provision also provides that for 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 
practitioner is technically capable to use an interactive 
telecommunications system, but the patient is not capable of, or does 
not consent to, the use of video technology.
---------------------------------------------------------------------------

    \9\ Id. 802(54).
    \10\ 42 CFR 410.78(a)(3).
---------------------------------------------------------------------------

    CMS recently revised 42 CFR 410.78(a)(3), to which the definition 
of ``practice of telemedicine'' refers, in a final rule published on 
November 19, 2021 (HHS CMS Rule).\11\ Previously, 42 CFR 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 42 CFR 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 HHS CMS rule 
revising 42 CFR 410.78(a)(3) stated, ``[T]wo-way, audio/video 
communications technology is the appropriate, general standard for 
telehealth services . . . .'' \12\
---------------------------------------------------------------------------

    \11\ Medicare Program; Calendar Year 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 (HHS CMS Rule), 86 FR 
64996, 65666 (Nov. 19, 2021).
    \12\ Id. at 65060.
---------------------------------------------------------------------------

    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.'' \13\ 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.\14\ 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 . . . .'' \15\
---------------------------------------------------------------------------

    \13\ Id. at 65061.
    \14\ Id.
    \15\ Id.
---------------------------------------------------------------------------

    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.'' \16\ 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 away from the exact home location during a telehealth 
service . . . .'').\17\
---------------------------------------------------------------------------

    \16\ Id. at 65060.
    \17\ Id. at 65059.
---------------------------------------------------------------------------

    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,'' \18\ the distant practitioner 
engaging in telehealth must make the option of audio-video 
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.'' \19\
---------------------------------------------------------------------------

    \18\ Id. at 65062.
    \19\ Id. at 65060.
---------------------------------------------------------------------------

    As stated in proposed 21 CFR 1306.34(a)(2), DEA is proposing to 
promulgate regulations that would require practitioners to otherwise 
comply with relevant State and Federal law.\20\ In those States where 
state law prohibits the prescription of a controlled substance based 
solely on an audio-only evaluation, the proposed regulation would not 
authorize the audio-only prescription of buprenorphine for opioid-use 
disorder (OUD). Thus, this proposed rulemaking's authorization of 
audio-only OUD prescribing would only apply in those States where such 
prescriptions are consistent with State law--it would authorize OUD 
buprenorphine prescribing based on an audio-video interaction in those 
states if doing so was otherwise consistent with State and Federal law.
---------------------------------------------------------------------------

    \20\ The CSA's definition of ``practice of telemedicine'' 
requires that it be ``in accordance with applicable Federal and 
State laws.'' 21 U.S.C. 802(54).
---------------------------------------------------------------------------

    DEA has consulted with representatives of the Secretary of Health 
and Human Services (HHS) regarding the substantive changes to the 
definition of ``interactive telecommunications systems'' in the HHS CMS 
Rule. Subsequent to the promulgation of the HHS CMS Rule, DEA is 
proposing to promulgate these specific conditions under which 
practitioners would be authorized to engage in the practice of 
telemedicine. The proposed changes to DEA's regulations herein, in 
conjunction with the changes already implemented in the

[[Page 12893]]

HHS CMS Rule, 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). 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).

II. Background

Buprenorphine Used in Treating Opioid Use Disorder

    DEA is proposing to promulgate regulations which would expand the 
circumstances under which practitioners are authorized to prescribe any 
schedule III, IV, or V narcotic drug approved by the Food and Drug 
Administration (FDA) specifically for use in the maintenance or 
detoxification treatment of OUD via a telemedicine encounter, including 
an audio-only telemedicine encounter that meets the standard of 42 CFR 
410.78(a)(3), provided certain requirements and conditions are met. The 
only schedule III-V narcotic drug that is currently approved by the FDA 
for such treatment is buprenorphine.\21\ Thus, DEA is proposing to 
expand the situations in which practitioners are authorized to 
prescribe buprenorphine via telemedicine for maintenance or 
detoxification treatment under limited circumstances to expand access 
to treatment for OUD while maintaining effective controls against 
diversion.
---------------------------------------------------------------------------

    \21\ Buprenorphine is a partial mixed opioid agonist that comes 
in tablets, sublingual, as well as injectable formulations. It 
produces effects such as euphoria or respiratory depression at low 
to moderate doses. With buprenorphine, however, these effects are 
weaker than full opioid agonists such as methadone and heroin.
---------------------------------------------------------------------------

    Buprenorphine comes in two formulations, a sole agent or combined 
with naloxone, both of which are very effective medications for the 
treatment of OUD.\22\ Commonly prescribed formulations of buprenorphine 
are indicated by the FDA for the treatment of OUD.\23\ DEA classifies 
buprenorphine as a schedule III narcotic controlled substance as it has 
a currently accepted medical use in treatment, and has less of a 
potential for misuse than the other controlled substances in schedules 
I and II, and its misuse may lead to moderate to low physical 
dependence or high psychological dependence.\24\ Studies have shown 
that buprenorphine helps to lower physical dependency on other opioids 
and reduces withdrawal symptoms, drug cravings, and morbidity and 
mortality for patients with OUD while also providing lower euphoric 
effects compared to other opioids.\25\ Moreover, buprenorphine is a 
partial opioid receptor agonist, it has less of an effect on 
respiratory depression, has a lower risk of overdose, and produces 
lower euphoric effects than full agonist opioids.\26\ Similar to other 
opioids, some patients and individuals who misuse buprenorphine may 
experience withdrawal upon stopping the medication. Thus, buprenorphine 
is an effective medication for treating OUD, especially when used as 
part of a complete treatment plan, but buprenorphine may also be 
dangerous when not used as prescribed.
---------------------------------------------------------------------------

    \22\ Treatment Improvement Protocol 63 for guidance on 
medication for OUD. Medications for Opioid Use Disorder, Treatment 
Improvement Protocol 63, SAMHSA (2021).
    \23\ Id.
    \24\ 21 U.S.C. 812(b)(3)(A)-(C); 21 CFR 1308.13(e)(2)(i).
    \25\ Buprenorphine, Substance Abuse and Mental Health Services 
Administration, (April 19, 2022), https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions/buprenorphine; see Medications for Opioid Use Disorder Save Lives, 
National Academies of Sciences, Engineering, and Medicine. (2019) 
https://nap.nationalacademies.org/catalog/25310/medications-for-opioid-use-disorder-save-lives.
    \26\ A Dahan et al., Buprenorphine induces ceiling in 
respiratory depression but not in analgesia, (March 07, 2006) 
https://pubmed.ncbi.nlm.nih.gov/16547090/.
---------------------------------------------------------------------------

    Combination products containing buprenorphine and naloxone can 
potentially deter misuse for certain individuals. For example, 
Suboxone[supreg] combines buprenorphine with naloxone, an opioid 
antagonist which is largely inactive when the product is administered 
sublingually as indicated, which is intended to discourage use by 
injection or insufflation. Specifically, when Suboxone[supreg], or a 
generic form of buprenorphine/naloxone combination product, is injected 
or insufflated, naloxone may cause uncomfortable side effects, 
including precipitated opioid withdrawal, which may deter certain forms 
of diversion. The issuance of Suboxone[supreg] by practitioners may be 
considered preferable to injectable drugs used to treat OUD, such as 
long-acting naltrexone or long-acting buprenorphine, as such treatment 
for OUD must be administered by a health care professional. Moreover, 
this formulation may be preferred by practitioners as patients must not 
be physically dependent on opioids before beginning oral or injected 
naltrexone, which requires a period of several days of abstinence. 
Inducing buprenorphine requires a shorter period of abstinence before 
induction to avoid precipitated withdrawal.

The Unprecedented Trafficking of Fentanyl and the Drug Poisoning Crisis

    The diversion and misuse of opioids lead to drug poisonings and 
deaths that can be mitigated by increased access to treatment for OUD. 
More than one million people in the United States have died from drug 
poisonings between 1999 and 2021.\27\ The rate of drug poisoning deaths 
involving synthetic opioids (including fentanyl) has substantially 
increased since 2013 to 2021. More recently, as stated above, an 
estimated 107,477 drug poisoning deaths occurred between September 1, 
2021 and August 31, 2022.\28\ Approximately 70% of these drug poisoning 
deaths involved fentanyl and other synthetic opioids.\29\
---------------------------------------------------------------------------

    \27\ Drug Overdose Deaths, Center for Disease Control, National 
Center for Injury Prevention and Control (Accessed on July 08, 
2022), https://www.cdc.gov/drugoverdose/deaths/.
    \28\ Centers for Disease Control and Prevention, National Center 
for Health Statistics, National Vital Statistics, Provisional Drug 
Overdose Death Counts, 12 Month-ending Provisional Number of Drug 
Overdose Deaths by Drug or Drug Class, https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. (Accessed January 17, 2023) (Sum 
of Predicted Value for the Number of Drug Overdose Deaths).
    \29\ Id.
---------------------------------------------------------------------------

    The availability of fentanyl throughout the United States has 
reached unprecedented heights. In 2022, DEA seized more than 50 million 
fake pills and 10,000 pounds of fentanyl powder equating to 
approximately 379 million deadly doses of fentanyl.\30\ These seizures 
have occurred in every State in the country. This is enough fentanyl to 
supply a potentially lethal dose to every member of the U.S. 
population.
---------------------------------------------------------------------------

    \30\ Drug Enforcement Administration Announces the Seizure of 
Over 379 million Deadly Doses of Fentanyl in 2022, (January 04, 
2023) https://www.dea.gov/press-releases/2023/01/04/drug-enforcement-administration-announces-seizure-over-379-million-deadly.
---------------------------------------------------------------------------

    Access to buprenorphine decreases the risk of drug poisoning.\31\ 
Moreover, increasing access to buprenorphine after a drug poisoning has 
also been associated with a reduced risk of death.\32\ Thus, DEA 
believes increasing patient access to MOUD is necessary to both prevent 
and ameliorate the

[[Page 12894]]

catastrophic drug poisonings that are occurring as a result of 
fentanyl. Importantly, a recent study found that the percentage of 
opioid overdose deaths involving buprenorphine did not increase in the 
months after prescribing flexibilities, including the remote induction 
and prescribing of buprenorphine for OUD treatment via telemedicine, 
were put in place during the COVID-19 pandemic.\33\
---------------------------------------------------------------------------

    \31\ Dadiomov, et al., Buprenorphine and naloxone access in 
pharmacies within high overdose areas of Los Angeles during the 
COVID-19 pandemic, Harm Reduction Journal. (June 29, 2022) https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-022-00651-3.
    \32\ Larochelle, et al., Medication for Opioid Use Disorder 
After Nonfatal Opioid Overdose and Association With Mortality, 
Annals of Internal Medicine, (August 07, 2018) https://www.acpjournals.org/doi/10.7326/M17-3107.
    \33\ Tanz, et al. Trends and characteristics of buprenorphine-
involved overdose deaths prior to and during the COVID-19 pandemic, 
JAMA. (January 20, 2023) https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2800689.
---------------------------------------------------------------------------

Diversion Risk of Buprenorphine

    Buprenorphine is a critical tool in efforts to stem the drug 
poisoning crisis that is occurring across the country. Still, 
buprenorphine, when used improperly, may lead to misuse and death.\34\ 
Self-medication for the management of symptoms may also be a motivation 
for non-prescribed misuse of buprenorphine.\35\ Moreover, issues with 
availability, accessibility, and acceptability of formal buprenorphine 
treatment may also contribute to non-prescribed buprenorphine 
misuse.\36\ Diversion of buprenorphine and other prescription opioids 
remains an issue across the country: in the past two years, DEA has 
seen Federal investigations of buprenorphine diversion across the 
country.\37\ Thus safeguards are necessary to mitigate the risk of 
diversion.\38\
---------------------------------------------------------------------------

    \34\ See ex. TDH Finds Some Overdose Deaths Associated With 
Buprenorphine. Tennessee Department of Health, (January 08, 2018) 
https://www.tn.gov/health/news/2018/1/8/tdh-finds-some-overdose-deaths-associated-with-buprenorphine.html; Bishop, S.D., 
Buprenorphine-Related Deaths in North Carolina from 2010 to 2018. 
(September, 2021) pubmed.ncbi.nlm.nih.gov/34145443/. See
    \35\ See Cicero et al. Understanding the use of diverted 
buprenorphine, Drug and Alcohol Dependence, (December 01, 2018) 
https://www.sciencedirect.com/science/article/pii/S0376871618307245; 
McDonald et al., Assessing Motivations for Nonprescribed 
Buprenorphine Use Among Rural Appalachian Substance Users, Journal 
of Addiction Medicine, (August 31, 2022) https://pubmed.ncbi.nlm.nih.gov/36044288/; Silverstein et al., On my own 
terms: Motivations for self-treating opioid-use disorder with non-
prescribed buprenorphine, Drug and Alcohol Dependence, (May 01, 
2020) https://pubmed.ncbi.nlm.nih.gov/32203863/; Butler et al., How 
Motivations for Using Buprenorphine Products Differ From Using 
Opioid Analgesics: Evidence from an Observational Study of internet 
Discussions Among Recreational Users, JMIR public health and 
surveillance, (March 25, 2020) https://pubmed.ncbi.nlm.nih.gov/32209533/.
    \36\ Silverstein et al., On my own terms: Motivations for self-
treating opioid-use disorder with non-prescribed buprenorphine, Drug 
and Alcohol Dependence, (May 01, 2020) https://pubmed.ncbi.nlm.nih.gov/32203863/; McLean et al., The international 
journal on drug policy, (July 20, 2019) https://pubmed.ncbi.nlm.nih.gov/31330267/.
    \37\ See, e.g., United States v. Kesari (S.D. W.Va. 2021) 
(Charleston doctor convicted of selling buprenorphine prescriptions 
for cash); United States v. Summers (E.D. Pa. 2018) (Philadelphia 
doctor operating ``National Association for Substance Abuse 
Prevention & Treatment'' pleaded guilty to selling buprenorphine 
prescriptions to drug dealers); United States v. SelfRefind (E.D. 
Ky. 2014) (largest buprenorphine clinic in the U.S. paid $15 million 
to resolve civil allegations regarding urine-testing scams, around 
the same time Kentucky suspended its director's authorization to 
prescribe buprenorphine drugs due to reckless overprescribing).
    \38\ See Mance E Buttram et al., Increasing rates of 
buprenorphine diversion in the United States, 2002 to 2019 (July, 31 
2021) https://pubmed.ncbi.nlm.nih.gov/34302707/. See Monico, L.B. 
et. al., Exploring nonprescribed use of buprenorphine in the 
criminal justice system through qualitative interviews among 
individuals recently released from incarceration. (April, 2021), 
https://pubmed.ncbi.nlm.gov/33612198 (Inmates and correctional 
officers have diverted buprenorphine, particularly in sublingual 
strip form, among inmates through illicit channels within 
correctional facilities as buprenorphine strips can easily be hidden 
and consumed without detection). See Richert, T. et. al., Illicit 
use of methadone and buprenorphine among adolescents and young 
adults in Sweden. (October 18, 2013), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3853648/. Lofwall MR, Walsh SL. A review of 
buprenorphine diversion and misuse: the current evidence base and 
experiences from around the world. J Addict Med. (September 01, 
2015) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4177012/. 
(showing that individuals may use diverted buprenorphine for the 
purposes of mitigating withdrawal symptoms in between use of illicit 
opioids).
---------------------------------------------------------------------------

Purpose and Need for Rulemaking

    DEA is proposing to promulgate regulations which would increase 
patient access to buprenorphine treatment for OUD with the goal of 
providing effective controls against diversion. Thus, DEA is proposing 
to promulgate regulations that would expand the circumstances under 
which registered practitioners would be authorized to prescribe 
buprenorphine for OUD via telemedicine, including an audio-only 
telemedicine encounter meeting the requirements of 42 CFR 410.78(a)(3), 
and inform these practitioners of their related obligations. DEA is 
also proposing to promulgate regulations that are necessary to mitigate 
the risk of diversion associated with this authorization.

Unmet Need To Facilitate Patient Access to Treatment for Opioid Use 
Disorder

    The majority of individuals suffering with OUD unfortunately do not 
receive treatment with FDA-approved medications.\39\ DEA is proposing 
to promulgate regulations that would address the unmet need to increase 
patient access to treatment for OUD. This rulemaking would enable those 
patients who, prior to being able to access treatment under the 
circumstances newly authorized, did not wish to, or did not possess the 
means to, be inducted for the treatment of OUD.
---------------------------------------------------------------------------

    \39\ Only one in Four People Needing Treatment for Opioid Use 
Disorder Received Medication, Columbia University School of Public 
Health, (March 23, 2022), https://www.publichealth.columbia.edu/public-health-now/news/only-one-four-people-needing-treatment-opioid-use-disorder-received-medication.
---------------------------------------------------------------------------

    Until recently, there was a nationwide shortage of practitioners 
authorized to dispense buprenorphine.\40\ Expanding the circumstances 
under which practitioners are authorized to prescribe via telemedicine 
encounters, including audio-only encounters, would increase access to 
treatment for those individuals with OUD who may not want to seek 
treatment, or are unable to seek treatment, due to various economic, 
geographical, sociological, and logistical reasons.
---------------------------------------------------------------------------

    \40\ Conway, Kevin P et al. Rural and urban differences in 
undersupply of buprenorphine provider availability in the United 
States, 2018, Addiction science & clinical practice (January 31, 
2022), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8802270/.
---------------------------------------------------------------------------

    Many patients may lack the financial means to obtain in-person 
treatment traditionally or through audio-video telemedicine encounters. 
Patients who are unhoused, unemployed, or facing other challenges may 
find it prohibitive to afford devices capable of audio-video 
telemedicine encounters or consistent access to wireless internet and/
or data plans adequate to support bandwidth demands of telemedicine 
encounters.\41\ Many individuals have unstable access, or experience 
interruptions in access, to this technology.\42\ Additionally, many 
rural and frontier communities do not have access to reliable broadband 
or wireless networks or an unwillingness to engage in telemedicine 
encounters directly.\43\
---------------------------------------------------------------------------

    \41\ DeLaCruz et al., Telemental Health for the Homeless 
Population: Lessons Learned when Leveraging Care, (December, 08 
2022) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9734763/.
    \42\ Id.
    \43\ Id.
---------------------------------------------------------------------------

    Expanding a registered practitioners' authority to prescribe 
buprenorphine for the treatment for OUD via telemedicine, including an 
audio-only telemedicine encounter meeting the standards of 42 CFR 
410.78(a)(3), would expand access to much needed medical treatment.\44\

[[Page 12895]]

Recent studies have revealed that, in some populations, upward of 94 
percent of the unhoused community had a cell phone, while a limited 
amount owned or had access to computers, tablets, or internet 
access.\45\ Not only would this rulemaking make it easier for patients 
to obtain treatment, many practitioners have shown a willingness to 
treat patients using an audio-only telecommunications system. An online 
survey showed that practitioners who engaged in the practice of 
telemedicine and prescribed buprenorphine considered telephonic means 
to be ``more accessible.'' \46\
---------------------------------------------------------------------------

    \44\ Under the Americans with Disabilities Act (ADA) and section 
504 of the Rehabilitation Act, practitioners are generally obligated 
to ensure effective communication and provide patients with 
disabilities with equal access to services. See, e.g., 28 CFR 
35.130(a); 28 CFR 35.130(b)(1); 28 CFR 35.160; 28 CFR 36.202(b); 28 
CFR 36.303(c); 45 CFR 84.4; 45 CFR 84.52. While audio-only 
telemedicine may be appropriate for some patients, it may not 
satisfy practitioners' ADA and section 504 obligations in all cases, 
particularly when patients are deaf or have hearing loss. See The 
Department of Justice, Civil Rights Division, The Americans With 
Disabilities Act and the Opioid Crisis: Combating Discrimination 
Against People in Treatment or Recovery (April 05, 2022) https://www.ada.gov/opioid_guidance.pdf.
    \45\ Molfenter T, Roget N, Chaple M, et al. Use of Telehealth in 
Substance Use Disorder Services During and After COVID-19: Online 
Survey Study. JMIR Ment Health. (February 08, 2021) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7895293/.
    \46\ Id.
---------------------------------------------------------------------------

Increased Access Must Be Consistent With Effective Controls Against 
Diversion and Public Health and Safety

    In concert with the goal of expanding patient access to MOUD,\47\ 
however, DEA must address diversion risks associated with the expanding 
access to narcotics over the phone. As established above, the diversion 
of buprenorphine is dangerous and may lead to misuse and sometimes 
fatal drug poisonings. Additionally, DEA must draft regulations which 
are consistent with public health and safety. Thus, DEA is proposing to 
promulgate regulations to require a thorough review of Prescription 
Drug Monitoring Program (PDMP) data prior to prescribing, a medical 
evaluation of the patient meeting certain conditions within 30 days, as 
well as comprehensive recordkeeping requirements.
---------------------------------------------------------------------------

    \47\ DEA references ``Medication Assisted Treatment'' (MAT) in 
its regulations in 21 CFR 1301.28. For the purposes of this 
rulemaking, all references to MAT refer to the dispensing or 
prescribing of Schedule III, IV, or V narcotic controlled drugs or 
combinations of narcotic controlled drugs that have been approved by 
FDA specifically for use in maintenance or detoxification treatment.
---------------------------------------------------------------------------

Prescription Drug Monitoring Program Review

    DEA is promulgating regulations that would require a practitioner 
to review and consider PDMP data prior to prescribing buprenorphine 
under the authority the regulations would grant.\48\ This review would 
allow the practitioner to make informed clinical decisions and identify 
and counsel the patient regarding higher risks (such as co-prescribed 
benzodiazepines), identify patients who may have obtained a 
buprenorphine or another recent prescription from another source 
(thereby preventing diversion), monitor for practitioners deliberately 
misprescribing buprenorphine, and prevent the diversion of such drugs 
through practitioners' lack of awareness that the patient on the other 
end of the line does not have an actual medical need or requires a more 
careful examination.\49\
---------------------------------------------------------------------------

    \48\ Proposed 21 CFR 1306.34(b)(2).
    \49\ Id. Under the proposed rule, a practitioner employed by or 
contracting with the Department of Veterans Affairs (VA) also would 
be required to review the VA internal prescription database.
---------------------------------------------------------------------------

    Without requiring practitioners to review and consider PDMP data, 
different practitioners could prescribe multiple 30-day supplies, or 
subsequent 30-day supplies indefinitely, to patients without realizing 
that they are doing so. Some studies have concluded that state rules 
requiring review of the PDMP are among the most effective interventions 
for preventing opioid drug poisonings and are correlated with a 
reduction in the proportion of patients that engage in drug seeking 
behavior.\50\ Thus, DEA believes it is necessary to require the review 
and consideration of PDMP data prior to prescribing buprenorphine so as 
to require due diligence on the part of the practitioner in order to 
effectively identify patients who have received prior prescriptions for 
buprenorphine or other prescriptions that might negatively interact 
with buprenorphine.
---------------------------------------------------------------------------

    \50\ See Tamara M Haegerich et al., Evidence for state, 
community and systems-level prevention strategies to address the 
opioid crisis, (Sep 19, 2019), https://pubmed.ncbi.nlm.nih.gov/31585357/.
---------------------------------------------------------------------------

    DEA believes a PDMP review requirement for prescribers, prior to 
writing a prescription, would balance the states' interest in 
regulating the practice of medicine with the overarching interest in 
mitigating the high risk of diversion for prescriptions which do not 
require face-to-face interaction with the prescribing physician--a 
balance in line with the text of 21 U.S.C. 802(54).

Requirement of Medical Evaluation in Person or in Presence of Another 
DEA Registrant Within 30 Days

    DEA is proposing to promulgate regulations which would require the 
patient receiving buprenorphine under the expanded authority of these 
regulations to receive a medical evaluation meeting certain 
requirements within 30 days of being prescribed buprenorphine for the 
induction of OUD treatment in order to obtain an additional supply of 
buprenorphine.\51\ In particular, under the proposed regulations, 
within 30 days, the patient would have to either be examined in person 
by the prescribing practitioner or practice, or the prescribing 
practitioner would have to examine the patient remotely while the 
patient is in the physical presence of another DEA-registered 
practitioner participating in an audio-video telemedicine encounter 
with the prescribing practitioner. Alternatively, the requirement of a 
medical evaluation is satisfied when the prescribing practitioner 
receives a qualifying telemedicine referral for medically-assisted 
treatment for opioid use disorder from a DEA-registered practitioner 
prior to issuing a prescription for controlled substances. Under this 
scenario, the patient has already received an in-person medical 
evaluation from the referring practitioner, and thus the prescribing 
practitioner is authorized to prescribe beyond the 30 day limit.
---------------------------------------------------------------------------

    \51\ Proposed 21 CFR 1306.34(b)(4).
---------------------------------------------------------------------------

    This requirement is necessary because the CSA generally requires 
each prescription for a schedule II through V controlled substance to 
be predicated upon at least one in-person medical evaluation. Although 
the proposed regulations would create an exception to this requirement, 
they must still maintain the CSA standard that prescriptions be tied to 
a medical evaluation in the physical presence of a DEA-registered 
practitioner. Without this provision, practitioners could theoretically 
prescribe buprenorphine without ever conducting a thorough medical 
evaluation of the patient.
    Moreover, requiring these medical evaluations subsequent to 
telemedicine encounters facilitates common practices by which some 
practitioners treat OUD. The required medical evaluation can enhance 
treatment by enabling the practitioner to conduct tests which make sure 
that buprenorphine is safe and appropriate for the patient.\52\ These 
include, but are not limited to, drug and toxicology screenings, liver 
enzyme tests, screenings for infectious diseases such as hepatitis, 
etc.\53\ Additionally, practitioners are able to assess conditions 
which may or may not be available in audio-only or even audio-video 
telemedicine encounters, such as signs of opioid intoxication or 
withdrawal, physical signs of opioid use, as well as the medical

[[Page 12896]]

consequences of opioid use.\54\ Thus, this required medical evaluation 
can result in enhanced treatment in some circumstances.
---------------------------------------------------------------------------

    \52\ Buprenorphine Quick Start Guide, SAMHSA https://www.samhsa.gov/sites/default/files/quick-start-guide.pdf.
    \53\ Id.
    \54\ Medications for Opioid Use Disorder, Treatment Improvement 
Protocol 63, SAMHSA (2021) https://store.samhsa.gov/sites/default/files/SAMHSA_Digital_Download/PEP21-02-01-002.pdf.
---------------------------------------------------------------------------

    For these reasons, and to comply with congressional directives in 
the Ryan Haight Act, DEA is proposing to require a medical evaluation 
meeting these standards in order to prescribe a supply in excess of 30 
days to assist DEA in the investigation and prosecution of malicious 
practitioners to ensure the public health and safety of patients and to 
help maintain effective controls against diversion.

Recordkeeping

    Comprehensive recordkeeping is necessary to provide sufficient 
documentation of the details of the audio-only telemedicine encounter 
and ensure practitioners' compliance with the provisions listed herein. 
Thus, DEA is requiring practitioners to keep comprehensive records 
establishing the nature of the encounter, the patient's proffered 
reason for the audio-only encounter (if the patient requests the 
telemedicine encounter be audio-only rather than audio-video), and all 
efforts to comply with PDMP checks.\55\
---------------------------------------------------------------------------

    \55\ Proposed 21 CFR 1306.34(7)(i)-(iv).
---------------------------------------------------------------------------

Prescribing Buprenorphine for the Induction of Medication for the 
Treatment of Opioid Use Disorder

    DEA recognizes that the induction of buprenorphine via a 
telemedicine encounter should not constitute the entirety of a 
treatment protocol for OUD for many patients. As explained by SAMHSA, 
the use of buprenorphine should be part of a ``comprehensive management 
program that includes other treatment plans such as psychosocial 
support.'' \56\ Thus, this rulemaking would be limited to the 
prescribing of buprenorphine simply for the treatment for OUD for 
patients via telemedicine encounters described in this rulemaking, and 
does not seek to circumvent or replace the individualized treatment 
protocols present in the usual course of treating an individual with 
OUD.\57\
---------------------------------------------------------------------------

    \56\ Buprenorphine Quick Start Guide, SAMHSA https://www.samhsa.gov/sites/default/files/quick-start-guide.pdf.
    \57\ Registrants may refer to Treatment Improvement Protocol 63 
for guidance on medication for OUD. Medications for Opioid Use 
Disorder, Treatment Improvement Protocol 63, SAMHSA (2021) https://store.samhsa.gov/sites/default/files/SAMHSA_Digital_Download/PEP21-02-01-002.pdf. See also SAMHSA, Telehealth for the Treatment of 
Serious Mental Illness and Substance Use Disorders, (2021). https://store.samhsa.gov/sites/default/files/SAMHSA_Digital_Download/PEP21-06-02-001.pdf.
---------------------------------------------------------------------------

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. DEA invites comments on the proposed practitioner 
recordkeeping obligations. 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 ``Telemedicine prescribing of controlled 
substances when the practitioner and the patient have not had a prior 
in-person medical evaluation'' (RIN 1117-AB40), 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 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.

III. Section-by-Section Discussion of Proposed Rule

Sec.  1300.04 Definitions Relating to the Dispensing of Controlled 
Substances by Means of the Internet

    DEA is proposing to amend 21 CFR 1300.04 to add definitions of 
``prescription drug monitoring program'' and ``telemedicine 
encounter.'' These terms play significant roles in the proposed 
regulations. Thus, to avoid any ambiguity about the meaning of those 
regulations, the proposed rule would specifically define those terms. 
Under the proposed rule, the term PDMP would mean a state controlled 
substance monitoring program, including a program supported by the 
Secretary of HHS under section 399O of the Public Health Service Act, 
as amended (42 U.S.C. 280g-3). The term ``telemedicine encounter'' 
would mean 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 in accordance with applicable Federal and State laws.

Sec.  1304.03 Persons Required To Keep Records and File Reports

    DEA is proposing to amend 21 CFR 1304.03 by adding new paragraph 
(k) requiring a practitioner to maintain copies of all qualifying 
telemedicine referrals that he or she issues.

Sec.  1304.04 Maintenance of Records and Inventories

    DEA is proposing to amend 21 CFR 1304.04 by adding new paragraphs 
(i)(1)-(2) that would require registrants to maintain all records 
required by 21 CFR 1306.34 at the registered location that is listed on 
their certificate of registration. In most cases, this will be the 
practitioner's primary registration in the state where the practitioner 
is located.
    These recordkeeping requirements will help ensure that all records 
associated with the prescribing practitioner, as well as any DEA-
registered practitioners who are present with the patient pursuant to 
proposed 21 CFR 1306.34(b)(5)(ii), will be stored in a consolidated 
location, which will expedite the investigatory process for DEA.

Sec.  1306.04 Purpose of Issue of Prescription

    DEA is proposing to amend 21 CFR 1306.04 by adding a new paragraph 
(e) to clarify when, and for what purpose, a practitioner may issue 
prescriptions pursuant to a telemedicine encounter under the expanded 
authority of these regulations. DEA proposes to authorize practitioners 
to issue prescriptions pursuant to 21 CFR 1306.34 if and only if the 
prescription is ``issued for maintenance or detoxification treatment 
and . . . not . . . for any other purpose.'' As stated above, 
buprenorphine is, at present, the only schedule III-V narcotic 
controlled substance that is approved by FDA for maintenance and 
detoxification treatment. Therefore, absent FDA approval of another 
schedule III-V narcotic controlled substance for the treatment of OUD, 
this provision only authorizes prescriptions for buprenorphine pursuant 
to telemedicine encounters for maintenance or detoxification treatment. 
This section would not authorize practitioners to issue prescriptions 
for other purposes, such as for the treatment of pain, as the 
overarching purpose of this rulemaking

[[Page 12897]]

is to facilitate the treatment of OUD in a safe manner.

Sec.  1306.34 Requirements for Individual Practitioners Who Conduct the 
Induction of Maintenance or Detoxification Treatment Via Telemedicine 
Encounter

    DEA is proposing to amend section 1306 by adding new section 
1306.34. This new section would describe the circumstances under which 
registrants are authorized to use the expanded authority of the 
proposed rule to prescribe buprenorphine pursuant to telemedicine 
encounters and the obligations of practitioners when doing so.
    DEA is proposing to add paragraph (a), which would list the 
conditions upon which a practitioner is authorized to prescribe 
buprenorphine via a telemedicine encounter under the proposed rule. 
First, unless otherwise excepted,\58\ registrants would be required 
under paragraph (a)(1) to obtain a DEA dispensing registration under 21 
U.S.C. 823(g), 21 CFR 1301.13(e)(1)(iv) in the state where the 
practitioner is located. Next, in order to issue prescriptions, 
paragraph (a)(2) would require the practitioner to be authorized by 
state law, or not otherwise prohibited by state law, to engage in the 
practice of telemedicine in both the state where the practitioner is 
located, as well as the state where the patient is located. This 
requirement is statutory, as the CSA requires that the ``practice of 
telemedicine'' involving controlled substances be conducted ``in 
accordance with applicable Federal and State laws'' pursuant to 21 
U.S.C. 802(54). In those states where state law prohibits the 
prescription of a controlled substance based solely on an audio-only 
evaluation,\59\ the proposed regulation would not authorize the audio-
only prescription of buprenorphine for OUD. Proposed paragraph (a)(3) 
would clarify that the prescription must comply with the provisions of 
the relevant CSA and DEA regulations that govern dispensing for 
maintenance and detoxification treatment (namely, 21 CFR 
1301.13(e)(1)(iv), and 21 CFR 1306.05(b)). In other words, the 
practitioner would have to possess a 21 CFR 1301.13(e)(1)(iv) 
registration in order to prescribe a schedule III, IV, or V narcotic 
drug approved by the FDA specifically for use in the maintenance or 
detoxification treatment. Proposed paragraph (a)(4) would codify the 
requirement that a practitioner be technically capable of using audio 
and video equipment permitting two-way, real-time interactive 
communication with the patient and the time of the telemedicine 
encounter. Proposed paragraph (a)(5) would state generally that the 
practitioner must comply with all other relevant requirements listed in 
this section.
---------------------------------------------------------------------------

    \58\ The proposed rule would except from this requirement VA 
practitioners, those practitioners contracting with the VA when 
treating a patient of the VA healthcare system, and those 
practitioners exempt from registration under section 303(f) in all 
States pursuant to Sec.  1301.23 when acting with the scope of the 
employment or contract that exempted them from the requirement of 
registration under section 303(f). It would be unduly burdensome to 
require registrants otherwise exempt from the requirement of DEA 
registration to become registered with DEA solely to make use of 
this proposed rule's telemedicine flexibility. The unique needs and 
expertise of the VA practitioners similarly weigh in favor of 
exempting them from this requirement. Moreover, in a related 
context, Congress indicated a desire, reflected in the Ryan Haight 
Act, that VA practitioners and those practitioners exempt from 
registration be uniquely allowed to engage in telemedicine without 
being registered in their patients' states. See 21 U.S.C. 
831(h)(1)(B).
    \59\ Based on DEA's review of state law, 25 states prohibit 
controlled substance prescriptions based on audio-only encounters.
---------------------------------------------------------------------------

    Next, paragraph (b) would list all the requirements for 
practitioners when issuing prescriptions. Proposed paragraph (b)(1) 
would require that all prescriptions issued based on a telemedicine 
encounter under the authority of the rule must be issued for a 
``Schedule III, IV, or V narcotic drug approved by the Food and Drug 
Administration specifically for use in maintenance or detoxification 
treatment'' and must be issued pursuant to 21 CFR 1306.04. This 
paragraph is designed to reduce the risk that buprenorphine will be 
prescribed for reasons other than a legitimate medical purpose. This 
paragraph further specifies that such prescriptions may only be issued 
pursuant to Sec.  1306.04 for the purpose of maintenance or 
detoxification treatment--i.e., the practitioner cannot prescribe 
buprenorphine for pain or any other purpose besides treatment of OUD.
    Proposed paragraph (b)(2) would require that practitioners review 
and consider relevant PDMP data in the state where the patient is 
located prior to prescribing.\60\ As stated above, this provision is an 
essential safeguard to ensure practitioners are conducting appropriate 
due diligence to mitigate risks of diversion and ensure the public 
health and safety of patients. Practitioners are encouraged to review 
all PDMP data accessible to them as a predicate to prescribing 
buprenorphine, but reviewing a period of at least one year prior to 
issuing a prescription would be required under the proposed rule. If 
less than one year of data is available, practitioners must review and 
consider the entire available period.
---------------------------------------------------------------------------

    \60\ A practitioner employed by or contracting with the VA 
additionally would have review the VA internal prescription 
database, subject to the same standards that would apply to a review 
of PDMP data.
---------------------------------------------------------------------------

    Proposed paragraph (b)(3) would specify the procedures for 
practitioners if they are unable to access PDMP data due to the PDMP 
system being ``non-operational or otherwise inaccessible as a result of 
a temporary technological or electrical failure.'' This paragraph 
includes circumstances involving temporary technological or electrical 
failures involved with the practitioner's attempts to access the PDMP 
data. This would include, but is not limited to, circumstances where 
practitioners are unable to access PDMP data because of public 
infrastructure failures such as loss of electricity and/or loss of 
internet as a result of inclement weather or natural disasters. For 
example, a practitioner could be experiencing state-wide outages in 
their internet service but otherwise be able to conduct a telemedicine 
encounter by using a different device such as a mobile phone or tablet 
that is connected to a satellite internet provider. In such 
circumstances, DEA notes that the practitioner must otherwise be 
capable of using audio and video equipment permitting two-way, real-
time interactive communication with the patient at the time of the 
telemedicine encounter prior to prescribing but is unable to access the 
PDMP system through the device at the time. In those exceptionally rare 
circumstances, DEA would encourage practitioners to use any means 
available to access PDMP data prior to prescribing, and practitioners 
must record their attempts to access the system as described below.
    Proposed paragraph (b)(3)(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 (3)(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 
(3)(iii) would require recordation of the practitioner's attempts to 
access the system (described in more detail below). The 7-day 
prescription can be refilled upon successful review of the PDMP by the

[[Page 12898]]

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 (2), or is otherwise able to comply with 
all relevant requirements in paragraph (3), proposed paragraph (4) 
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 requirement 
would limit the supply of buprenorphine prescribed pursuant to an 
audio-only telemedicine encounter to a maximum of a 30-day supply. 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.
    Proposed paragraph (b)(5) would clarify what satisfies the medical 
evaluation requirement for the purposes of (b)(4). Such a medical 
evaluation would include the prescribing practitioner conducting a 
medical evaluation while the patient is in the physical presence of the 
prescribing practitioner in (b)(5)(i), or by the alternative schemes 
listed in (b)(5)(ii) and (iii). Under the alternative proposed in 
(b)(5)(ii), the patient would not be in the physical presence of the 
prescribing practitioner, but the patient would have to be in the 
physical presence of another DEA-registered practitioner pursuant to 
proposed (b)(5)(ii)(A)-(D). This other non-prescribing, physically 
present practitioner would have to be acting in the usual course of 
professional practice and in accordance with applicable State law. 
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 him or 
herself, he or she 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.
    Additionally, the requirement of a medical evaluation is satisfied 
when the prescribing practitioner receives a qualifying telemedicine 
referral from a DEA registered practitioner under (b)(5)(iii). Under 
this scheme, the patient must have received a face-to-face evaluation 
from a DEA registered practitioner, referred to simply as the referring 
practitioner. The referring practitioner may then issue a written 
qualifying telemedicine referral \61\ to the prescribing practitioner 
based on the diagnosis, prognosis, or treatment that was provided for 
the medical issue upon which the medical evaluation was predicated 
pursuant to paragraphs (A) and (C). Moreover, under paragraph (B), the 
referral practitioner must communicate the results of the medical 
evaluation which include any diagnosis, prognosis, or treatment to the 
prescribing practitioner prior to the prescribing practitioner issuing 
the prescription. If the prescribing practitioner issues the 
prescription to the patient prior to receiving the information provided 
in (B), this does not qualify as a medical evaluation for the purposes 
of Sec.  1306.34(b)(5) and the patient must receive a medical 
evaluation in the manner described in paragraph (b)(5)(i) or 
(b)(5)(ii). Once a medical evaluation meeting the specified criteria is 
performed, the proposed rule would allow a practitioner to continue 
prescribing to the patient, so long as doing so was consistent with 
legitimate medical purposes and a subsequent evaluation was not 
required by law or other provisions of this chapter.
---------------------------------------------------------------------------

    \61\ Proposed 21 CFR 1300.04(k). Note that this definition was 
proposed by DEA in a distinct Notice of Proposed Rulemaking that 
also addresses telemedicine. See RIN 1117-AB40, published elsewhere 
in this issue of the Federal Register. The public is encouraged to 
respond to the proposed definition in any/both documents.
---------------------------------------------------------------------------

    Last, proposed paragraph (b)(6) would create recordkeeping 
requirements for practitioners who issue prescriptions in the manner 
described by this section. Paragraph (6)(i) would require records 
indicating whether the telemedicine encounter was conducted using 
audio-video or audio-only technology. This recordkeeping requirement is 
essential for investigation purposes, as DEA would have no other means 
of verifying the nature of the telemedicine encounter. Proposed 
paragraph (6)(ii) would also require the practitioner to record the 
patient's reason for requesting an audio-only encounter, if the 
encounter was audio-only. This provision would also assist DEA, as it 
may be used as evidence to establish whether the practitioner issued 
the prescription in the usual course of professional practice. Proposed 
paragraph (6)(iii) would require practitioners to record all attempts 
to comply with paragraph (b)(2) when the practitioner is able to access 
the PDMP system. This provision is necessary as it enables DEA to 
verify whether the registrant knew or should have known of the 
patient's prior prescription history. Proposed paragraph (6)(iv) would 
require practitioners who were unable to access their state PDMP system 
to record ``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.'' This 
provision is necessary as it enables DEA to verify the practitioner's 
attempts to access the PDMP system, the reasons for being unable to 
access, and any subsequent attempts to access the system. Proposed 
paragraph (6)(v) would require, if the patient seeks a medical 
evaluation pursuant to 1306.34(b)(5)(ii), the prescribing practitioner 
to record the full name, DEA registration number, National Provider 
Identifier (NPI) number of the DEA-registered practitioner in the 
physical presence of the patient, and if issued 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). This provision is necessary as this information 
is essential to future investigations and these details of the medical 
evaluation, such as the physically present practitioner's name, may not 
otherwise be recorded by the prescribing practitioner.

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,

[[Page 12899]]

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. While this proposed 
rule is not economically significant, OMB has determined that this 
proposed rule is a ``significant regulatory action'' under E.O. 12866, 
section 3(f). Accordingly, this proposed rule has been submitted to OMB 
for review.
    Due to COVID-19 public health emergency, DEA issued guidance which 
authorized the prescribing of buprenorphine to new and existing 
patients with OUD via telemedicine, including audio-only telemedicine 
(e.g., telephone) by otherwise authorized practitioners without 
requiring such practitioners to first conduct an examination of the 
patient in person.\62\ To continue the flexibilities of telemedicine, 
including audio-only telemedicine, for prescribing schedule III-V 
controlled substances which are approved for maintenance treatment or 
withdrawal management beyond the public health emergency, DEA proposes 
to promulgate regulations which would balance the need to increase 
patient access to legitimate medical treatment with the goal of 
providing effective controls against diversion. Thus, DEA is proposing 
to expand the conditions under which a practitioner is authorized to 
prescribe buprenorphine via telemedicine, including an audio-only 
telemedicine encounter, and to describe obligations which arise once a 
practitioner prescribes to patients.
---------------------------------------------------------------------------

    \62\ ``Dear Registrant'' letter to DEA Qualifying Practitioners 
and DEA Qualifying Other Practitioners, Thomas W. Prevoznik, Deputy 
Assistant Administrator, Diversion Control Division, March 31, 2020.
---------------------------------------------------------------------------

Number of Telemedicine Encounters, Providers, and Patients
    The number of telemedicine encounters, including audio-only 
telemedicine, leading to buprenorphine prescriptions under the 
temporary guidance during the public health emergency forms the basis 
for estimating the number of telemedicine encounters pursuant to this 
proposed rule.
    DEA estimated the number of telemedicine encounters associated with 
an initial buprenorphine prescription by applying the data provided by 
the Centers for Medicare & Medicaid (CMS) data on Medicare Part D 
telemedicine services that led to buprenorphine prescriptions to the 
number of all buprenorphine prescriptions. Based on CMS claims data 
provided by the Department of Health and Human Services Office of 
Inspector General (HHS OIG), from March 2020, the start of the COVID-19 
health emergency shutdowns, to December 2021, 24,285 Medicare fee-for-
service and managed care telemedicine services, including audio-only 
telemedicine, were identified as being linked to buprenorphine Part D 
prescriptions fills.\63\ These telemedicine services were provided by 
7,733 providers to 15,521 beneficiaries.\64\
---------------------------------------------------------------------------

    \63\ HHS OIB, March 2022. HHS OIG analyzed telemedicine billing 
codes and patient information to identify telemedicine visits within 
a 48-hour period prior to a buprenorphine prescription fill 
associated with the same patient, and where the prescribing provider 
is the same or related to the billing or rendering provider of the 
telemedicine visit.
    \64\ Id.
---------------------------------------------------------------------------

    Based on the CMS data, the telemedicine services and associated 
buprenorphine prescriptions identified spiked at the beginning of the 
public health emergency and stayed relatively steady in 2021. 
Therefore, 2021 data is used to estimate the number of telemedicine, 
including audio-only telemedicine, encounters for this analysis. In 
2021, there were a total of 1,929,151 Part D buprenorphine 
prescriptions associated with 1,332,353 beneficiaries.\65\ Over the 
same period, there were 11,956 telemedicine Medicare fee-for-service 
and managed care telemedicine services, including audio-only 
telemedicine, identified as being linked to buprenorphine Part D 
prescriptions fills.\66\ These telemedicine services were provided by 
4,533 providers to 8,182 patients.\67\ The 1,929,151 Part D 
buprenorphine claims associated with 1,332,353 beneficiaries equates to 
a ratio of 1.45 claims per beneficiary. Therefore, the 11,956 services 
represent an estimated 8,257 (11,956/1.45) initial prescriptions, which 
equates to 0.43 percent (8,257/1,929,151) of total Part D claims for 
buprenorphine (1,929,151 total claims). Based on IQVIA data, the total 
number of new prescriptions for buprenorphine in the U.S. in 2021 was 
15,782,652.\68\ Applying the telemedicine share of total Part D 
buprenorphine prescriptions to the estimated number of total services 
associated with a buprenorphine prescription yields an estimated 67,458 
(0.43 percent x 15,782,652) initial prescriptions. DEA believes this is 
a high estimate, as the telemedicine share of total Part D 
buprenorphine prescriptions may include telemedicine services allowed 
by regulation prior to the PHE.
---------------------------------------------------------------------------

    \65\ Id.
    \66\ Id.
    \67\ HHS OIB, May 2022.
    \68\ IQVIA, National Prescription Audit, September, 2022.
---------------------------------------------------------------------------

Affected Persons
    This proposed rule would affect practitioners prescribing schedule 
III-V controlled substances for the induction of a maintenance 
treatment or withdrawal management via telemedicine using audio-video 
or audio-only technology and the patients they treat using this 
technology. Based on the analysis above, DEA expects the proposed rule 
to affect 67,458 patients, annually. As previously discussed, in 2021, 
8,182 patients received a prescription for buprenorphine under the 
Medicare Part D program, from 4,533 providers, equating to a ratio of 
approximately 1.80 patients per provider. Applying this ratio to the 
number of affected patients, DEA estimates 37,373 providers are 
affected by this proposed rule.

Impact on Physicians or Practitioners

    The proposed rule would permit the use of audio-video or audio-only 
telemedicine provided that the practitioner (1) meets all requisite 
State and Federal registration requirements for both prescribing of 
controlled substances and engaging in the practice of telemedicine, (2) 
reviews PDMP data regarding any controlled substance prescriptions 
issued to the patient in the previous year, (3) is limited to a 30-day 
supply, across all such prescriptions, until the practitioner conducts 
an in-person medical evaluation, and (4) maintains records of all 
prescriptions issued pursuant to a telemedicine encounter, including 
whether the encounter was audio-only or audio-video, and if by audio-
only, the patient's reason for requesting an audio-only

[[Page 12900]]

encounter. Below is the analysis of the four requirements stated above.
    1. Meet all requisite State and Federal registration requirements: 
Practitioners who would participate in audio-video or audio-only 
telemedicine pursuant to this proposed rule are assumed to already be 
conducting telemedicine and already have the necessary equipment to 
conduct audio-video or audio-only telemedicine at no or minimal 
additional cost. Additionally, DEA assumes all practitioners who would 
participate in telemedicine pursuant to this proposed rule to already 
meet all requisite registration requirements, i.e., holding a DEA 
registration in the State where the practitioner is located, holding a 
DEA registration, etc. Additionally, DEA assumes all practitioners who 
would issue prescriptions via telemedicine encounters pursuant to this 
proposed rule are authorized under DEA regulations under 21 CFR 
1301.13(e)(1)(iv) as well as the states where the practitioner is 
located (unless otherwise excepted). Therefore, the impact of this 
requirement is minimal.
    2. Review of PDMP data: DEA estimates each review of the PDMP will 
take 4 minutes, or 0.067 hours, by a practitioner. Based on an 
estimated loaded hourly rate of $157.87,\69\ the cost of a review of 
the PDMP is $10.52 ($157.87 x 0.067). Applying this cost to 67,458 
services, the total cost of PDMP review is $709,970 ($10.52 x 67,458), 
annually. While many practitioners already check PDMP prior to issuing 
a prescription for a controlled substance for a variety of reasons, DEA 
will consider the full cost of checking PDMP, $709,970, a cost of this 
proposed rule to be conservative.
---------------------------------------------------------------------------

    \69\ For the purpose of this analysis, the cost per registrant 
is estimated by multiplying the loaded labor rate by the estimated 
time to complete the review. The loaded labor rate is based on the 
estimated loaded hourly wage for 29-1229, Physicians, all other. 
Bureau of Labor Statistics, Occupational Employment and Wages, May 
2021, https://www.bls.gov/oes/current/oes291229.htm. The average 
hourly wage is $111.30, with benefits estimated at an additional 
41.84 percent of the base wage. The load factor is calculated by 
comparing the benefits for private workers as a share of wages, 
29.5%/70.5% = 41.84%. Bureau of Labor Statistics, Employer Costs for 
Employee Compensation--December 2021, https://www.bls.gov/news.release/pdf/ecec.pdf. The loaded wage was therefore $111.30 x 
1.4184 = $157.87 per hour for private physicians, all other.
---------------------------------------------------------------------------

    3. Limited to a 30-day supply: Currently, inducting MOUD with 
schedule III-V controlled substances requires an in-person visit or a 
telemedicine encounter as defined in Sec.  1300.04(i). This proposed 
rule would expand the circumstances under which individual 
practitioners are authorized to prescribe schedule III-V controlled 
substances which are approved for maintenance treatment or withdrawal 
management via a telemedicine encounter, including an audio-only 
telemedicine encounter. Therefore, this proposed rule would enable a 
treatment option that would otherwise be unavailable. While DEA does 
not have a basis to quantify the economic impact of the 30-day supply 
limit, 30 days of medication for inducting treatment is a benefit over 
not receiving any medication. Additionally, as stated earlier, 
requiring an in-person visit with the prescribing practitioner within 
30 days is consistent with the usual course of MOUD and purpose of the 
Ryan Haight Act, and necessary to enforce the CSA and its implementing 
regulations.
    4. Maintains records of all prescriptions issued pursuant to a 
telemedicine encounter, including the supervising physician name where 
applicable under state law and DEA number when the prescription is 
issued by a physician assistant or nurse practitioner, whether the 
encounter was audio-only or audio-video and, if audio-only, the 
patient's reason for requesting an audio-only encounter: While DEA 
estimates two minutes for a prescriber to make such recording, DEA 
believes prescribers are already performing many of these tasks as 
usual and ordinary practice and any additional recordkeeping as a 
result of this proposed rule is minimal. Therefore, there is minimal 
additional cost associated with this requirement.
    In summary, the total cost to practitioners is $709,970 annually, 
which is the cost associated with checking PDMP for all patients.

Impact on Patients

    As discussed earlier, DEA estimates this proposed rule will affect 
67,458 patients per year. DEA anticipates that patients will fall into 
one of two categories:
    (1) Patients who would otherwise not receive treatment or 
prescription for OUD absent the proposed rule change. These patients 
have no other means to receive treatment. They are unable to visit a 
physician in-person or otherwise visit a practitioner engaged in the 
practice of telemedicine as defined in Sec.  1300.04(i), but able to 
have an audio-video or audio-only telemedicine visit pursuant to this 
proposed rule.
    (2) Patients who would eventually receive treatment and 
prescription even absent the proposed rule change. These patients are 
able to either visit a physician in-person or have telemedicine visit 
with a practitioner engaged in the practice of telemedicine as defined 
in Sec.  1300.04(i); however, such visit might have been delayed for 
any variety of reason, i.e., lack of reliable transportation, work or 
caretaking commitments, long wait times for an appointment with the 
physician, etc. This proposed rule, if implemented, would create 
additional flexibilities, potentially allowing patients to access 
treatment more quickly than would be possible absent this proposed 
rule.
    DEA does not have a basis to estimate how many of the estimated 
67,458 patients fall into the two groups. However, DEA anticipates a 
larger impact for the first group. The impact on the first group of 
patients is a result of receiving treatment for OUD. There would be a 
cost of treatment and the benefit generated from the treatment, which 
would not have been possible without this proposed rule. The impact on 
the second group would be the result of receiving treatment sooner than 
they would have without this proposed rule. For both groups, the impact 
could potentially be lifesaving. However, DEA does not have access to 
data that would permit it to estimate the number of lives the improved 
access could save. There would be a cost of treatment and the benefit 
of earlier treatment, including potential cost-offsets associated with 
reduced healthcare and public safety expenditures. According to a 
December 2021 research report, treatment with buprenorphine for a 
stable patient provided in a certified Opioid Treatment Program, 
including medication and twice-weekly visits were $115 per week or 
$5,980 per year.\70\ This is likely higher than the cost of treating a 
stable patient in a primary care setting, where patients are more 
likely to see providers once per week and where there are no associated 
specialized costs. However, using the $5,980 per year estimate serves 
to establish an upper boundary for potential costs in any cost-benefit 
comparison. Estimates of the impact of buprenorphine use in the 
treatment of OUD suggest a 23.7% decrease in total deaths, and 31.2% 
reduction in drug poisonings (both fatal and nonfatal). In total, the 
combined cost-savings of buprenorphine (including both health-care 
costs as well as criminal justice costs) was estimated by one study at 
$60,000 per person.\71\ At the costs listed above, the savings from the 
treatment of

[[Page 12901]]

one person would cover the cost of buprenorphine-assisted treatment for 
ten others.
---------------------------------------------------------------------------

    \70\ How much does opioid treatment cost?, NIDA. (April 13, 
2021), https://nida.nih.gov/publications/research-reports/medications-to-treat-opioid-addiction/how-much-does-opioid-treatment-cost.
    \71\ Fairley et al., Cost-effectiveness of Treatments for Opioid 
Use Disorder. JAMA Psychiatry, (July 01, 2021).
---------------------------------------------------------------------------

    A study published in 2021 of the societal costs for OUD found that 
the ``[C]osts for opioid use disorder and fatal opioid drug poisoning 
in 2017 were estimated to be $1.02 trillion. The majority of the 
economic burden is due to reduced quality of life from opioid use 
disorder and the value of life lost due to fatal opioid drug 
poisoning.'' \72\ According to the report, in 2017 total non-fatal 
costs are $471 billion and total fatal costs are $550 billion and there 
were 2.1 million persons ages 12 years and older with an OUD, and 
47,000 fatal opioid drug poisonings.\73\ Non-fatal costs include costs 
associated with health care, substance use disorder treatment, criminal 
justice, lost productivity, and the value of reduced quality of life. 
Dividing the total non-fatal cost of $471 billion by the number of 
persons ages 12 and older with an OUD (2.1 million), the societal cost 
(cost burden on society) of non-fatal OUD is approximately $224,000 
($471 billion/2.1 million) per person with OUD per year. While DEA is 
unable to quantify how many of the affected patients will be 
successfully treated for OUD or how many fatal opioid drug poisonings 
will be avoided as a result of this proposed rule, the potential 
economic benefit is disproportionally large compared to any cost 
associated with this rule. A small reduction in OUD has the potential 
to save money in excess of the total costs of the proposed rule.
---------------------------------------------------------------------------

    \72\ Florence et al., The economic burden of opioid use disorder 
and fatal opioid overdose in the United States, (2017).
    \73\ Id.
---------------------------------------------------------------------------

Risk of Diversion

    The proposed rule will reduce the requirements imposed on 
practitioners who wish to prescribe schedule III-V controlled 
substances as part of medication treatment for OUD. DEA understands 
that there is a risk of misuse and diversion of drugs approved for the 
use in maintenance treatment or withdrawal management, which could be 
increased by expanded prescribing.
    While the proposed rule may increase the risk of diversion, with 
the proposed safeguards, and given the safety profile of buprenorphine, 
DEA estimates this increased risk will be minimal. Requirements to 
check the PDMP prior to issuance of a prescription, 30-day limitations, 
in-person requirements for follow-up appointments, and more detailed 
requirements for recordkeeping are expected to minimize the diversion 
of buprenorphine via telemedicine, including audio-only telemedicine. 
Practitioners already have the authority to prescribe MOUD. Studies 
have found that, in 2019, the percentage of buprenorphine misuse among 
adults with past-year use was 29.2%. Of those adults who misused 
buprenorphine in a previous year, 71.8%-74.7% did not have their own 
prescription.\74\ Given the misuse of buprenorphine is often for self-
treatment of OUD symptoms, these numbers underscore the need for 
expanded access to buprenorphine treatment for OUD.
---------------------------------------------------------------------------

    \74\ Han, Beth et al. ``Trends in and Characteristics of 
Buprenorphine Misuse Among Adults in the US.'' JAMA Netw Open. 2021 
Oct 1; 4(10):e2129409. Accessed 9/15/2022.
---------------------------------------------------------------------------

    The growth of waivers to prescribe buprenorphine was smallest among 
prescribers working in small nonmetropolitan counties. Prescribers in 
rural counties were associated with low buprenorphine dispensing.\75\ 
DEA believes that by providing increased access for rural areas, the 
benefits of increasing access to MOUD outweigh any added risk of 
diversion as the result of this proposed rule.
---------------------------------------------------------------------------

    \75\ Id.
---------------------------------------------------------------------------

Other Potential Costs

    DEA also examined the cost of technology, both capital investment 
and operation expenses, in order to provide telemedicine in compliance 
with the proposed rule. DEA believes that the use of telemedicine will 
not require any additional capital expenditures on the part of 
practitioners or patients. Recordkeeping requirements are likely to 
have a minimal impact because current recordkeeping practices are 
likely to meet the requirements imposed by the proposed rule, and any 
additional time is expected to be minimal. Electronic medical records 
may be updated in the future to reflect the proposed rule change, such 
as the inclusion of a flag for a telemedicine visit, including an 
audio-only visit, but such changes are likely to be minor and included 
as part of any normal software update.

Summary

    In summary, DEA estimates this proposed rule would affect 37,373 
providers and 67,458 patients, annually. DEA believes that the proposed 
rule would increase patient access to MOUD for two types of patients: 
those who otherwise would be unable or unwilling to seek treatment, as 
well as those who would seek treatment but with some form of delay. 
Increased access to MOUD is expected to reduce the number of opioid 
drug poisonings annually, however DEA cannot quantify the size or total 
benefits of such a reduction. There would be a slight increase in labor 
costs per practitioner, due to increased time spent reviewing PDMP 
databases. The estimated total cost to the 37,373 providers is 
$709,970, annually. DEA estimates recordkeeping requirements are likely 
to have a minimal impact because current recordkeeping practices are 
likely to meet the requirements imposed by the proposed rule, and any 
additional time is expected to be minimal. The increase in the 
availability and flexibility of treatment with schedule III-V 
controlled substances may increase the risk of diversion, however DEA 
believes that any increase would be small, and outweighed by the 
benefit to patients and reduction in the societal cost of opioid use 
disorder.

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 
States, on the relationship between the national government and the 
States, 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 will not have a significant economic 
impact on a substantial number of small entities.
    Due to the COVID-19 public health emergency, DEA issued guidance 
which authorized prescribing of buprenorphine to new and existing 
patients with OUD via telephone by otherwise authorized practitioners

[[Page 12902]]

without requiring such practitioners to first conduct an examination of 
the patient in person.\76\ To continue the flexibilities of 
telemedicine, including audio-only telemedicine, for prescribing 
Schedule III-V controlled substances which are approved for maintenance 
treatment or withdrawal management beyond the public health emergency, 
DEA proposed to promulgate regulations which would balance the need to 
increase patient access to legitimate medical treatment with the 
overarching goal of providing effective controls against diversion. 
Thus, DEA is proposing to expand the conditions under which a 
registered practitioner is authorized to prescribe buprenorphine via 
telemedicine, including through an audio-only telemedicine encounter, 
and describe the obligations which arise once a practitioner prescribes 
to patients.
---------------------------------------------------------------------------

    \76\ ``Dear Registrant'' letter to DEA Qualifying Practitioners 
and DEA Qualifying Other Practitioners, Thomas W. Prevoznik, Deputy 
Assistant Administrator, Diversion Control Division, March 31, 2020.
---------------------------------------------------------------------------

Affected Persons
    This proposed rule would affect practitioners prescribing schedule 
III-V controlled substances for the induction of maintenance treatment 
or withdrawal management of patients with OUD using telemedicine and 
the same patients being treating using telemedicine. As stated above, 
DEA estimates this proposed rule would affected 37,373 practitioners 
and 67,458 patients, annually. Because practitioners are individuals 
and not small entities, this analysis examines the impact of the 
proposed rule on affected physicians and small entities that employ the 
affected physicians.
    The proposed rule would permit the use of audio-video or audio-only 
telemedicine provided that the practitioner (1) meets all requisite 
State and Federal registration requirements for both prescribing of 
controlled substances and engaging in the practice of telemedicine, (2) 
reviews PDMP data regarding any controlled substance prescriptions 
issued to the patient in the previous year, (3) is limited to a 30-day 
supply, across all such prescriptions, until the practitioner conducts 
an in-person medical evaluation, and (4) maintains records of all 
prescriptions issued pursuant to a telemedicine encounter, including 
the supervising physician name and DEA registration number, in cases 
where the prescription is issued by a nurse practitioner or physician 
assistant, whether the encounter was audio-only or audio-video and, if 
audio-only, the patient's reason for requesting an audio-only 
encounter.
    A significant number of physicians and Mid-Level Practitioners 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 would 
employ the physicians and MLP's who would deliver MOUD service via 
telemedicine, including an audio-only telemedicine encounter. 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'').\77\ The following business 
NAICS codes are estimated to represent businesses that employ the 
affected persons, potential applicants:
---------------------------------------------------------------------------

    \77\ 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. The data table is available at https://www.sba.gov/sites/default/files/files/static_us_11.xls (last visited April 25, 2022).

 621111--Offices of Physicians, Except Mental Health 
Specialists
 621112--Offices of Physicians, Mental Health Specialists
 621420--Outpatient Mental Health and Substance Abuse Centers
 622110--General Medical and Surgical Hospitals
 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 621111, 621112, 621420, 622110, and 622210 
are annual receipts of $14 million, $12 million, $16.5 million, $41.5 
million, and $41.5 million, respectively.\78\
---------------------------------------------------------------------------

    \78\ SBA. Table of Size Standards, Effective July 14, 2022. 
https://www.sba.gov/document/support-table-size-standards (last 
visited September 28, 2022.)
---------------------------------------------------------------------------

    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 there are 161,286, 10,561, 6,523, 2,560, and 396 entities in 
the 621111, 621112, 621420, 622110, and 622210 industries, 
respectively. Based on the SUSB data on the firm sizes, DEA estimates 
there are 157,060, 10,392, 5,773, 1,047, and 188 small entities in the 
621111, 621112, 621420, 622110, and 622210 industries, respectively. In 
total, DEA estimates there are 181,326 entities in the five potentially 
affected industries, of which 174,460 (96.2 percent) are small 
entities. The analysis is summarized in table 1 below.

                             Table 1--Number of Affected Entities and Small Entities
----------------------------------------------------------------------------------------------------------------
                                                                     Number of       SBA size        Number of
                           NAICS code                                  firms       standard ($)    small firms *
----------------------------------------------------------------------------------------------------------------
621111--Offices of Physicians, excepting Mental Health                   161,286      14,000,000         157,060
 Specialists....................................................
621112--Offices of Physicians, Mental Health Specialists........          10,561      12,000,000          10,392
621420--Outpatient Mental Health and Substance Abuse Centers....           6,523      16,500,000           5,773
622110--General Medical and Surgical Hospitals..................           2,560      41,500,000           1,047
622210--Psychiatric and Substance Abuse Hospitals...............             396      41,500,000             188
                                                                 -----------------------------------------------
    Total.......................................................         181,326                         174,460
                                                                 -----------------------------------------------

[[Page 12903]]

 
        Percent of Total........................................                                           95.8%
----------------------------------------------------------------------------------------------------------------
* Not all decimal places shown.

    From above, E.O. 12866 section, DEA estimates there will be 67,458 
telemedicine services pursuant to this proposed rule, including audio-
only telemedicine services, rendered by 37,373 providers to 67,458 
patients, annually. Therefore, this proposed rule is estimated to 
affect 37,373 individual practitioners employed in industries with 
173,730 small businesses potentially affected by this proposed rule. 
Since some small entities will employ more than one practitioner, the 
number of affected small entities is expected to be less than 174,460 
and are expected to be proportionally across the five industries. DEA 
considers a substantial number of small entities are affected if more 
than 30 percent of small entities in the affected industries is 
affected. Therefore, at 21.4 percent of the total small entities 
(37,373 providers/173,730 small entities), the number of small entities 
affected by this proposed rule is estimated to be not a substantial 
number for any of the representative industries.
    The cost of the proposed rule impacts the affected entities and 
small entities on a ``per person'' basis. Rather than estimating the 
number of physicians and MLPs per firm, then the cost per firm, then 
whether the cost is significant, DEA employed a more direct approach 
based on the following logic:
     In order to continue as going concerns, the affected firms 
must generate enough revenue to pay the wages of physicians and MLPs, 
and other operating expenses.
     Therefore, revenue for firms must be greater than the 
wages paid to practitioners and MLPs.
     Therefore, if the cost of the proposed rule is not 
economically significant when compared to individual wages for 
practitioners and MLPs, the cost of the proposed rule is not 
economically significant when compared to the annual revenue of the 
firms.
    From 2021 data provided by HHS OIG, DEA estimates that 8,182 
patients received telemedicine services prior to receiving a 
prescription for buprenorphine. These services were provided by 4,533 
separate providers, for approximately 1.8 patients per provider. DEA 
assumed that this ratio is the same for the general populations of 
practitioners and patients, at 37,373 providers and 67,458 patients.
    DEA estimates a non-loaded median hourly wage of $111.30 \79\ and 
$56.99 \80\ for potentially affected physicians and MLPs, respectively. 
Applying the hourly wage rates to the estimated time to apply, DEA 
estimates the labor cost per PDMP review is $7.42 ($111.30 x 4/60) and 
$3.80 ($56.99 x 4/60) per physician and MLP, respectively. The non-
loaded wage rates are calculated to represent the cost to the 
individual, whereas previously the loaded wage rates were calculated to 
represent the total cost of employment to the entity and to the 
economy. These rates are multiplied by 1.8 patients, for total labor 
costs of $13.39 and $6.86, respectively.
---------------------------------------------------------------------------

    \79\ Bureau of Labor Statistics, Occupational and Employment and 
Wages, May 2021, 29-1229 Physicians, All Others, https://www.bls.gov/oes/current/oes291229.htm.
    \80\ Bureau of Labor Statistics, Occupational and Employment and 
Wages, May 2021, 29-1071 Physician Assistants, https://www.bls.gov/oes/current/oes291071.htm.
    Bureau of Labor Statistics, Occupational and Employment and 
Wages, May 2021, 29-1171 Nurse Practitioners, https://www.bls.gov/oes/current/oes291171.htm.
    DEA calculated the weighted average hourly wage based on the 
distribution of physician assistants (36.2%) and nurse practitioners 
(63.8%).
---------------------------------------------------------------------------

    The non-loaded unit cost of conducting a PDMP review is compared to 
the non-loaded annual wage rate for physicians and MLPs. Based on the 
Bureau of Labor Statistics' (``BLS'') Occupational and Employment and 
Wages data, DEA estimates an average annual wage of $231,500 for 
physicians, $118,553 for MLPs.\81\ Unit costs of $13.39 and $6.86 
represent 0.01 percent of those wages. Table 3 presents the details of 
the calculation.
---------------------------------------------------------------------------

    \81\ Notes 80 and 81.

                                                       Table 3--Costs and Fees as Percent of Wages
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                            Additional
                                                            Mean hourly   Time to review     Cost per      Cost per 1.8     Mean annual      costs as
                                                             wage ($)         (hours)       patient ($)    patients ($)      wage ($)       percent of
                                                                                                                                               wage
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physicians..............................................          111.30            0.06            7.42           13.39         231,500            0.01
MLP.....................................................           56.99            0.06            3.80            6.86         118,553            0.01
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The economic impact of additional time spent conducting PDMP 
reviews represents a small fraction (0.01 percent) of annual wages. DEA 
estimates the proposed rule will not have a significant economic impact 
on individual physicians and MLPs. The small entities that employ the 
potentially affected physicians and MLPs are expected to generate 
enough revenue to pay their wages. Therefore, DEA concludes the 
proposed rule will not have a significant economic impact on a 
substantial number of small entities.

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

[[Page 12904]]

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. The 
collections of information contained in the proposed rule, and 
identified as such, have been submitted to OMB for review under section 
3507(d). DEA has identified the following collection(s) of information 
related to this proposed rule. An agency may not conduct or sponsor, 
and a person is not required to respond to a collection of information 
unless it displays a valid OMB control number. Copies of existing 
information collections approved by OMB may be obtained at https://www.reginfo.gov/public/do/PRAMain.

A. Collections of Information Associated With the Notice of Proposed 
Rulemaking

    Title: Dispensing Records of DEA Registered Practitioners.
    OMB Control Number: 1117-NEW.
    Form Number: N/A.
    DEA is proposing to require practitioners to record additional 
information than what is currently required in 21 CFR 1304.03(c). 
Proposed 21 CFR 1306.34(7)(i) would require records indicating whether 
the telemedicine encounter was conducted using audio-video or audio-
only technology. Proposed paragraph (7)(ii) would also require the 
practitioner to record the patient's reason for requesting an audio-
only encounter, if the encounter was audio-only. Proposed paragraph 
(7)(iii) would require practitioners to record all attempts to comply 
with paragraph (b)(2) when the practitioner is able to access the PDMP 
system. Last, proposed paragraph (7)(iv) would require practitioners 
who were unable to access their state PDMP system to record ``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 proposed rule would 
also require practitioners to record the name and DEA registration 
number of a supervising physician, in cases where the prescription was 
issued by a nurse practitioner or physicians assistant.
    DEA estimates the following number of respondents and burden 
associated with this collection of information:
     Number of respondents: 37,373.
     Frequency of response: 1.804986 (as needed, calculated).
     Number of responses: 67,458.
     Burden per response: 0.06666667 hours.
     Total annual hour burden: 4497 hours.

B. Request for Comments Regarding the Proposed Collections of 
Information

    Written comments and suggestions from the public and affected 
entities concerning the proposed collections of information are 
encouraged. DEA solicits comment on the following issues:
     Whether the proposed collection of information is 
necessary for the proper performance of the functions of the DEA, 
including whether the information will have practical utility.
     The accuracy of the 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- AB78/Docket No. DEA-948. 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) 776-3882.

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 revising paragraph (j) and adding paragraph 
(m) to read as follows:


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

* * * * *
    (j) The term prescription drug monitoring program (or PDMP) means a 
State controlled substance monitoring program, including a program 
supported by the Secretary of Health and Human Services under section 
399O of the Public Health Service Act, as amended (42 U.S.C. 280g-3).
* * * * *
    (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).
* * * * *

PART 1304--RECORDS AND REPORTS OF REGISTRANTS

0
3. 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
4. Amend Sec.  1304.03 by adding paragraphs (i) and (j) to read as 
follows:


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

* * * * *
    (i) [Reserved]
    (j) A practitioner shall maintain copies of all qualifying 
telemedicine referrals, as defined in Sec.  1300.04(k) of this chapter, 
that they issue.
0
5. Amend Sec.  1304.04 by adding paragraph (i), to read as follows.


Sec.  1304.04  Maintenance of records and inventories.

* * * * *
    (i)(1) A practitioner who prescribes controlled substances in the 
course of maintenance or detoxification treatment pursuant to a 
telemedicine encounter as authorized by Sec.  1306.34 shall maintain 
records required by this part at the registered location on the 
practitioner's certificate of registration issued pursuant to section 
303(f) of the Act (21 U.S.C. 823(g)).

[[Page 12905]]

    (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 Sec.  1306.34(b)(5)(ii) of this chapter, 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 AND DISPENSING

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

    Authority:  21 U.S.C. 802, 821, 829, 871(b), unless otherwise 
noted.

0
7. Amend Sec.  1306.04 by adding paragraph (e), to read as follows.


Sec.  1306.04  Purpose of issue of prescription.

* * * * *
    (e) In addition to the requirements of this section, all narcotic 
prescriptions issued pursuant to Sec.  1306.34 may only be issued for 
maintenance or detoxification treatment and may not be issued for any 
other purpose.
0
8. Add Sec.  1306.34 to read as follows.


Sec.  1306.34  Requirements for individual practitioners who conduct 
the induction of maintenance or detoxification treatment via 
telemedicine encounter.

    (a) An individual practitioner not otherwise authorized to engage 
in the practice of telemedicine as defined in Sec.  1300.04(i) of this 
chapter is authorized to prescribe any Schedule III, IV, or V narcotic 
drug approved by the Food and Drug Administration specifically for use 
in the maintenance or detoxification treatment via a telemedicine 
encounter as defined in Sec.  1300.04(m) of this chapter if all of the 
following conditions are met:
    (1) The practitioner is registered under section 303(f) of the Act 
(21 U.S.C. 823(g)), 21 CFR 1301.13(e)(1)(iv) in the State in which the 
practitioner is located. This requirement does not apply to Department 
of Veterans Affairs practitioners, those practitioners employed by and 
treating a patient enrolled in the Department of Veterans Affairs 
health system, or those practitioners exempt from registration under 
section 303(f) in all States pursuant to Sec.  1301.23 of this chapter 
when acting with the scope of the employment or contract that exempted 
them from the requirement of registration under section 303(f);
    (2) The practitioner is authorized by State law to engage in the 
practice of telemedicine, or not otherwise prohibited by State law from 
practicing telemedicine, in the State where the practitioner is located 
and in the State where the patient is located;
    (3) The practitioner is authorized under Sec.  1301.28 of this 
chapter;
    (4) The practitioner must be technically capable of conducting a 
telemedicine encounter by using audio and video equipment permitting 
two-way, real-time interactive communication with the patient pursuant 
to 42 CFR 410.78(a)(3); and
    (5) The practitioner complies in all other respects to the 
requirements of this section.
    (b) An individual practitioner who is authorized to engage in the 
practice of telemedicine as described in paragraph (a) must comply with 
the following requirements prior to issuing a prescription.
    (1) The prescription must only be issued for a Schedule III, IV, or 
V narcotic drug approved by the Food and Drug Administration 
specifically for use in in maintenance or detoxification treatment and 
must be issued for that purpose pursuant to Sec.  1306.04.
    (2) Prior to issuing the prescription, the practitioner, including 
a practitioner employed by the Department of Veterans Affairs, must 
review and consider the data regarding any controlled substance 
prescriptions issued to the patient in the last year that is contained 
in the prescription drug monitoring program (PDMP) described in Sec.  
1300.04(o) of this chapter in the State where the patient is located, 
or, if less than one year of data is available, in the entire available 
period. If less than one year of data is available, practitioners must 
review and consider the entire available period. A practitioner 
employed by the Department of Veterans Affairs also must 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 one year of data is available, in 
the entire available period.
    (3) If the practitioner is unable to obtain the PDMP data (or, if 
employed by the Department of Veterans Affairs, the Department of 
Veterans Affairs internal prescription database) 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 a prescription authorizing the 
dispensing of no more than a 7-day supply across all such prescriptions 
for Schedule III, IV, or V narcotic drugs approved by the Food and Drug 
Administration specifically for maintenance or detoxification treatment 
until completing the review described in paragraph (b)(2) of this 
section, and verifying that any previous prescriptions were not issued 
pursuant to a telemedicine encounter;
    (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 (b)(2) of this section within 7 days of the telemedicine 
encounter; and
    (iii) The practitioner must record the attempts to access the 
system pursuant to paragraph (b)(6) of this section.
    (4) Upon completing the review described in paragraph (b)(2) of 
this section, the practitioner may issue prescriptions authorizing the 
dispensing of no more than a 30-day supply across all such 
prescriptions, including any prescriptions issued pursuant to paragraph 
(b)(3)(i) of this section, for Schedule III, IV, or V narcotic drugs 
approved by the Food and Drug Administration specifically for 
maintenance or detoxification treatment until the practitioner has 
conducted a medical evaluation as described in paragraph (b)(5) of this 
section.
    (5) For the purposes of this section, the required medical 
evaluation may either be:
    (i) An evaluation during which the patient is treated by, and in 
the physical presence of, the prescribing practitioner; or
    (ii)(A) An evaluation during which the patient is treated by, and 
in the physical presence of, a DEA-registered practitioner (other than 
the prescribing practitioner);
    (B) This practitioner in the physical presence of the patient is 
acting in the usual course of professional practice;
    (C) The evaluation is conducted in accordance with applicable State 
law; and
    (D) 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; or
    (iii) An evaluation that was conducted by a DEA registered 
practitioner who:
    (A) Issued a written qualifying telemedicine referral under 21 CFR 
1300.04(k) for the patient to the prescribing practitioner;
    (B) Communicated the results of the evaluation by sharing the 
electronic

[[Page 12906]]

medical record which includes, at a minimum, the diagnosis, prognosis, 
and treatment of the patient prior to the prescribing practitioner 
issuing the prescription; and
    (C) Has issued the written referral based on the diagnosis, 
prognosis or treatment that occurred as a result of the medical 
evaluation.
    (6) Practitioners who issue prescriptions for controlled substances 
in the course of maintenance or detoxification treatment via a 
telemedicine encounter under this section must maintain records of all 
prescriptions issued pursuant to Sec. Sec.  1304.03 and 1304.04 of this 
chapter indicating the following:
    (i) Whether the telemedicine encounter was conducted using audio-
video or audio-only technology;
    (ii) If the telemedicine encounter was conducted using audio-only 
technology, the patient's reason for requesting the audio-only 
encounter;
    (iii) All efforts to comply with paragraph (b)(2) of this section 
when the practitioner is able to obtain the PDMP data (and, if employed 
by the Department of Veterans Affairs, the data from the Department of 
Veterans Affairs internal prescription database);
    (iv) If the practitioner failed to access the PDMP (or, if employed 
by the Department of Veterans Affairs, Department of Veterans Affairs 
internal prescription database) system as described in paragraph (b)(2) 
of this section, the dates and times that the practitioner attempted to 
obtain the data, the reason why the practitioner was unable to gain 
access, and any follow-up attempts made to obtain the data;
    (v) 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 paragraph (b)(5)(ii) of this section, the full name, DEA 
registration number, and National Provider Identifier (NPI) number for 
the DEA-registered practitioner in the physical presence of the 
patient; and
    (vi) If issued a qualifying telemedicine referral, the name, and 
NPI of the referring practitioner and a copy of the referral and any 
communications shared pursuant to Sec.  1306.34(b)(5)(iii).

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. 2023-04217 Filed 2-27-23; 2:30 pm]
BILLING CODE 4410-09-P