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Proposed Rule2022-27193

Medications for the Treatment of Opioid Use Disorder

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Published

December 16, 2022

Issuing agencies

Health and Human Services Department

Abstract

The Department of Health and Human Services (HHS or "the Department") is issuing this notice of proposed rulemaking (NPRM) to solicit public comment on its proposal to modify its regulations regarding medications for the treatment of opioid use disorder.

Full Text

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[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Proposed Rules]
[Pages 77330-77365]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27193]

[[Page 77329]]

Vol. 87

Friday,

No. 241

December 16, 2022

Part IV

Department of Health and Human Services

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42 CFR Part 8

Medications for the Treatment of Opioid Use Disorder; Proposed Rule

Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 /
Proposed Rules

[[Page 77330]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

42 CFR Part 8

RIN 0930-AA39

Medications for the Treatment of Opioid Use Disorder

AGENCY: Substance Abuse and Mental Health Services Administration
(SAMHSA), Department of Health and Human Services.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Department of Health and Human Services (HHS or ``the
Department'') is issuing this notice of proposed rulemaking (NPRM) to
solicit public comment on its proposal to modify its regulations
regarding medications for the treatment of opioid use disorder.

DATES: Comments due on or before February 14, 2023.

ADDRESSES: Written comments may be submitted through any of the methods
specified below. Please do not submit duplicate comments.
<bullet> Federal eRulemaking Portal: You may submit electronic
comments at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the instructions at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> for submitting electronic comments.
Attachments should be in Microsoft Word or Portable Document Format
(PDF), and please refer to RIN 0930-AA39 in all comments.
<bullet> Regular, Express, or Overnight Mail: You may mail written
comments (one original and two copies) to the following address only:
The Substance Abuse and Mental Health Services Administration, Center
for Substance Abuse Treatment, 5600 Fishers Lane, Room 13-E-30,
Rockville, MD 20857.

Note: Due to the COVID-19 pandemic, SAMHSA notes receipt of mail
may be delayed and encourages submission of comments electronically
to the docket.

Inspection of Public Comments: All comments received by the
accepted methods and due date specified above may be posted without
change to content to <a href="https://www.regulations.gov">https://www.regulations.gov</a>, which may include
personal information provided about the commenter, and such posting may
occur after the closing of the comment period. However, the Department
may redact certain content from comments before posting, including
threatening language, hate speech, profanity, graphic images, or
individually identifiable information about a third-party individual
other than the commenter. Because of the large number of public
comments normally received on Federal Register documents, SAMHSA is not
able to provide individual acknowledgments of receipt. Please allow
sufficient time for mailed comments to be received timely in the event
of delivery or security delays. Comments submitted by fax or email, and
those submitted after the comment period will not be accepted.

FOR FURTHER INFORMATION CONTACT: Robert Baillieu, MD, MPH, Physician
and Senior Advisor, SAMHSA/CSAT, 5600 Fishers Lane, Room 13-E-30,
Rockville, MD 20857, Phone: 202-923-0996, Email:
<a href="/cdn-cgi/l/email-protection#cc9ea3aea9beb8e28eada5a0a0a5a9b98cbfada1a4bfade2a4a4bfe2aba3ba">[email&#160;protected]</a>.

SUPPLEMENTARY INFORMATION: The discussion below includes an Executive
Summary and overview describing the need for the proposed rule changes,
a section-by-section description of the proposed modifications, and the
impact statement and other required regulatory analyses. The Department
solicits public comment on all aspects of the proposed rule. Persons
interested in commenting on the provisions of the proposed rules can
assist the Department by preceding discussion of any particular
provision or topic with a citation to the section of the proposed rule
being discussed.

Executive Summary

A. Overview

The Controlled Substances Act (CSA), under 21 U.S.C. 823(g)(1),
requires ``practitioners who dispense narcotic drugs to individuals for
maintenance treatment or detoxification treatment'' to ``obtain
annually a separate registration for that purpose'' except as provided
under 21 U.S.C. 823(g)(2). Section 823(g)(1) also provides that,
``[t]he Attorney General shall register an applicant to dispense
narcotic drugs to individuals for maintenance treatment or
detoxification treatment (or both)'' if, among other things, the
applicant ``is determined by the Secretary to be qualified (under
standards established by the Secretary [of HHS]) to engage in the
treatment with respect to which registration is sought[,]'' and ``if
the Secretary determines that the applicant will comply with standards
established by the Secretary (after consultation with the Attorney
General) respecting the quantities of narcotic drugs which may be
provided for unsupervised use by individuals in such treatment.'' 21
U.S.C. 823(g)(1)(A)-(C). The standards authorized under section
823(g)(1) have been published as regulations under part 8 of title 42
of the Code of Federal Regulations (42 CFR part 8 or ``part 8'').\1\
Among other things, these regulations establish the procedures by which
the Secretary of HHS determines whether a program is qualified to
dispense opioid agonist medications in the treatment of opioid use
disorders, and standards regarding the appropriate quantities of opioid
agonist medications that may be provided for unsupervised use by
individuals undergoing such treatment. See 42 CFR 8.1. In addition, ``a
program or practitioner engaged in opioid treatment of individuals with
an opioid agonist treatment medication'' that is also ``registered
under 21 U.S.C. 823(g)(1)'' is described as an ``Opioid Treatment
Program'' (OTP). See 42 CFR 8.2.\2\ The statue, at 21 U.S.C. 823(g)(2),
also authorizes a waiver from the registration requirements of 21
U.S.C. 823(g)(1) for qualifying practitioners seeking to dispense or
prescribe schedule III, IV, or V controlled substances that are Food
and Drug Administration (FDA)-approved for use in ``maintenance and
detoxification treatment.'' Practitioners with a waiver under section
823(g)(2) are limited in the number of patients with opioid use
disorder they may treat at any one time, and depending on the
practitioner's experience or qualifications, this statutory limitation
is set at either 30, 100, or 275. See 21 U.S.C. 823(g)(2)(B)(iii). The
Secretary is also authorized to change the patient limitations by
regulation, and qualifying practitioners must satisfy the requirements
of 42 CFR 8.610 through 8.655 ``(or successor regulations)'' in order
to treat up to 275 patients, which is the maximum number under existing
law. See 21 U.S.C. 823(g)(2)(B)(iii)(II)(dd).\3\
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\1\ For readability, the Department refers to specific sections
of 42 CFR part 8 using a shortened citation with the ``Sec. ''
symbol except where necessary to distinguish title 42 citations from
other CFR titles, such as title 45 CFR, and in footnotes where the
full reference is used.
\2\ The terms ``narcotic drugs'' and ``detoxification
treatment'' included in this paragraph are found in statute. SAMHSA
recognizes that these terms can be stigmatizing for some people, and
not aligned with current terminology. SAMHSA uses ``opioid agonist
medications'' (see Treatment Improvement Protocol (TIP) 63) as an
alternative to ``narcotic drugs'' and ``withdrawal management'' as
the alternative to ``detoxification treatment''.
\3\ See <a href="https://www.govinfo.gov/content/pkg/USCODE-2016-title21/html/USCODE-2016-title21-chap13-subchapI-partC-sec823.htm">https://www.govinfo.gov/content/pkg/USCODE-2016-title21/html/USCODE-2016-title21-chap13-subchapI-partC-sec823.htm</a>.
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In this NPRM, the Department proposes to modify certain provisions
of part 8 to update OTP accreditation and certification standards,
treatment standards for the provision of medications for opioid use
disorder (MOUD) as dispensed by OTPs, and requirements for individual

[[Page 77331]]

practitioners eligible to dispense (including by prescribing) certain
types of MOUD with a waiver under 21 U.S.C. 823(g)(2).
The proposal draws on experience from the COVID-19 Public Health
Emergency (PHE), as well as more than 20 years of practice-based
research. The COVID-19 PHE necessitated changes to policy guidance and
legal exemptions to protect the public's health, promote social
distancing and to preserve patient and staff safety among OTPs. In
March 2020, SAMHSA published flexibilities in the provision of
unsupervised doses of methadone and the use of telehealth in initiating
buprenorphine.\4\ These flexibilities represented the first substantial
change to OTP treatment and medication delivery standards in over 20
years. A growing body of research has demonstrated that these
flexibilities facilitate access to treatment and eliminate criteria
that promote stigma and discourage people from accessing care from
OTPs.
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\4\ See <a href="https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf">https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf</a> and <a href="https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf">https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf</a>.
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This proposed rule not only makes these flexibilities permanent,
but also updates standards to reflect an accreditation and treatment
environment that has evolved since part 8 went into effect in 2001.
Accordingly, the Department is proposing to update part 8 to: promote
practitioner autonomy; remove stigmatizing or outdated language; create
a patient-centered perspective; and reduce barriers to receiving care.
These elements have been identified in the literature and in feedback
as being essential to promoting effective treatment in
OTPs.5 6 7
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\5\ Suen LW, Coe WH, Wyatt JP, Adams ZM, Gandhi M, Batchelor HM,
Castellanos S, Joshi N, Satterwhite S, P[eacute]rez-Rodr[iacute]guez
R, Rodr[iacute]guez-Guerra E, Albizu-Garcia CE, Knight KR, Jordan A.
Structural Adaptations to Methadone Maintenance Treatment and Take-
Home Dosing for Opioid Use Disorder in the Era of COVID-19. Am J
Public Health. 2022 Apr;112(S2):S112-S116. doi: 10.2105/
AJPH.2021.306654. PMID: 35349324; PMCID: PMC8965183.
\6\ Kleinman MB, Felton JW, Johnson A, Magidson JF. ``I have to
be around people that are doing what I'm doing'': The importance of
expanding the peer recovery coach role in treatment of opioid use
disorder in the face of COVID-19 health disparities. J Subst Abuse
Treat. 2021 Mar;122:108182. doi: 10.1016/j.jsat.2020.108182. Epub
2020 Oct 21. PMID: 33160763; PMCID: PMC7577312.
\7\ Suen LW, Castellanos S, Joshi N, Satterwhite S, Knight KR.
``The idea is to help people achieve greater success and liberty'':
A qualitative study of expanded methadone take-home access in opioid
use disorder treatment. Subst Abus. 2022;43(1):1143-1150. doi:
10.1080/08897077.2022.2060438. PMID: 35499469.
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To this end, the definition of a qualifying practitioner has been
expanded to include a provider who is appropriately licensed by the
state to prescribe (including dispense) covered medications and who
possesses a waiver under 21 U.S.C. 823(g)(2). Admission criteria have
been updated to remove significant barriers to entry, such as the one-
year requirement for opioid use disorder (OUD),\8\ while also defining
the scope and purpose of the `initial' and `periodic' medical
examinations. The proposed rule also includes new definitions to expand
access to evidence-based practices such as split dosing, telehealth and
harm reduction activities. Further to this, outdated terms such as
`detoxification' have been revised to remove stigmatizing language.
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\8\ See 42 CFR 8.12(e)(1).
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The Department promotes practitioner autonomy and individualized
care by proposing to revise the provision containing the criteria for
unsupervised doses of methadone. This includes removal of consideration
of the length of time an individual has been in treatment, as well as
rigid reliance on toxicology testing results that demonstrate complete
and sustained abstinence from all substances prone to misuse. Based on
the clinical judgment of the treating provider, patients may be
eligible for unsupervised, take home doses of methadone upon entry into
treatment. This recognizes the importance of the practitioner-patient
relationship, and is consistent with modern treatment standards. It
also allows for greater flexibility in creating plans of care that
promote recovery activities such as employment, while also eliminating
the barrier of frequent visits for individuals without access to
reliable transportation.\9\
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\9\ Ware OD, Frey JJ, Cloeren M, Mosby A, Imboden R, Bazell AT,
Huffman M, Hochheimer M, Greenblatt AD, Sherman SA. Examining
Employment and Employment Barriers Among a Sample of Patients in
Medication-Assisted Treatment in the United States, Addictive
Disorders & Their Treatment: December 2021--Volume 20--Issue 4--p
578-586 doi: 10.1097/ADT.0000000000000295.
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Accreditation and certification standards have been reviewed to
codify the use of online/electronic forms, to eliminate types of
certification that are no longer in use, and to update existing types
of certification in a manner that reflects established practice. Part 8
has also been updated to facilitate information sharing between
Accreditation Bodies and SAMHSA, particularly in those circumstances
where there have been changes or violations in accreditation. The
proposed rule also clarifies administrative issues pertaining to mobile
medication units and interim treatment.
The proposed changes seek to make treatment in OTPs more accessible
to patients, easier to deliver for providers and supportive of
evidence-based and patient-centered care. In proposing these changes,
SAMHSA has relied on published evidence, stakeholder feedback and the
need to expand access to care in the face of a growing overdose
epidemic, exacerbated by the COVID-19 PHE.\10\ This is brought further
into focus by the HHS declaration of a public health emergency for the
opioid crisis which has been regularly renewed since 2017.\11\ The
proposed changes are expansive but are focused on permanently
implementing existing flexibilities and updating practices. In this
way, SAMHSA believes that much of what is proposed in the rule will not
represent a significant burden for OTPs and, in fact, will offer many
benefits to providers and patients. The proposed rule, therefore,
supports OTPs in their on-going provision of equitable and evidence-
based care to often marginalized patients with OUD. The proposed rule
also is consistent with the HHS Overdose Prevention Strategy which
calls for increasing access to and the uptake of evidence-based
treatments for substance use disorders.\12\
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\10\ Tanz LJ, Dinwiddie AT, Snodgrass S, O'Donnell J, Mattson
CL, Davis NL. A qualitative assessment of circumstances surrounding
drug overdose deaths during the early stages of the COVID-19
pandemic. SUDORS Data Brief, No 2. Atlanta, GA: Centers for Disease
Control and Prevention, U.S. Department of Health and Human
Services; 2022.
\11\ See <a href="https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx">https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx</a>.
\12\ See <a href="https://www.hhs.gov/overdose-prevention/">https://www.hhs.gov/overdose-prevention/</a>.
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B. Effective and Compliance Dates

The proposed effective date of a final rule would be 60 days after
publication of the final rule and the compliance date would be 6 months
after the effective date. Entities subject to the final rule would have
until the compliance date to achieve compliance with this rule.

C. Summary of Major Proposals

The Department proposes the following changes to 42 CFR part 8 that
revise, delete, replace, or add sections. This section summarizes major
proposals in this NPRM. Additional proposed revisions are not listed
here because they are not considered major.\13\ All proposed changes
are discussed in detail in section III of this NPRM:
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\13\ Generally, the proposals not listed make wording changes,
not substantive changes. These proposals are reviewable in the
regulatory text.

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[[Page 77332]]

1. Heading.
The heading of part 8 has been changed from Medication Assisted
Treatment for Opioid Use Disorders to Medications for the Treatment of
Opioid Use Disorder to reflect currently accepted medical terminology
and to remove language that is widely viewed to be stigmatizing.
2. Subpart A.
Subpart A currently addresses accreditation and includes steps that
accreditation bodies must follow to obtain approval to accredit OTPs.
It also sets forth accreditation bodies' responsibilities, including
the use of accreditation elements, during accreditation surveys. In the
proposed rule, these specifications are relocated to subpart B, which
still would include Certification of Opioid Treatment Programs. The
proposed rule limits subpart A to the preamble and definitions.
3. Section 8.1--Scope.
Revised Sec. 8.1 to reflect modern medical terminology, to detail
updated acronyms, and for clarity. Of note, the term medication
assisted treatment (MAT) has been updated to MOUD, and the term
treatment program has been changed to opioid treatment program
throughout the proposed rule.
4. Section 8.2--Definitions.
Revised Sec. 8.2 to add and update definitions. Added definitions
include: care plan; harm reduction; individualized dose; long-term care
facility; recovery support services; split dosing; and telehealth.
Existing definitions updated include: comprehensive treatment;
medication for opioid use disorder; and practitioner. The term
detoxification treatment is removed and replaced with withdrawal
management.
5. Section 8.3--Application For Approval as an Accreditation Body.
Added details of policies and procedures expected of accreditation
bodies, particularly that accreditation bodies shall include staff
physician(s) with experience in treating OUD with MOUD in their survey
team. A correction has been made to the email address to which the
accreditation application is submitted. The current rule calls for the
accreditation bodies' training policies to be provided as part of their
application process. Furthermore, this regulation would be updated to
ensure that accreditation bodies provide training policies specifically
related to training of survey team members. In addition to state or
territorial governments, the proposed rule also provides for Indian
Tribes to apply for approval as an accreditation body.
6. Section 8.4--Accreditation Body Responsibilities.
Amended to clarify expectations for cooperation of accreditation
bodies with SAMHSA's oversight. These include steps to be taken by
accreditation bodies in response to OTPs that are found to not be
complying with accreditation or certification standards, such as follow
up on corrective measures and confirmation of timely corrections. Time
frames are also established for submission of survey reports. The
proposed rule adds a requirement that all records of accreditation
activities be made available to SAMHSA upon request. Current
requirements regarding accreditation body follow up on complaints are
maintained, but the proposed rule adds a requirement that accreditation
bodies notify SAMHSA of all aspects of a complaint response within 5
days of receipt. The current rule requiring surveyors to recuse
themselves from surveys due to conflict of interest is amended to
clarify that such conflicts must be documented by the accreditation
body and made available to SAMHSA.
7. Section 8.11--Opioid Treatment Program Certification.
This section is amended to update categories of certification, to
clarify SAMHSA's expectation that OTPs maintain certification, and to
establish procedures for OTPs whose certification has lapsed. Current
terms for the extension of certification are amended to clarify the
circumstances in which an extension could be requested, and the means
of requesting an extension are defined in the proposed rule. The
proposed rule also updates the certification application process to
reflect the shift from paper applications to electronic submission, and
the email address for submission of supporting documents is corrected.
The proposed rule removes ``transitional certification'' which
expired as a category of certification in 2003. The wording of
``provisional certification'' is amended to clarify that it is a
category of certification available only to new programs that have not
been previously certified, and a new category of ``conditional
certification'' has been added for OTPs that have received a one-year
conditional accreditation status from an accrediting body--an
organization that has been approved by the Secretary of HHS to accredit
OTPs--in order for operations to continue or resume as the OTP takes
steps needed to achieve permanent certification. The criteria for
granting certification extensions outside of routine certification
renewals has been expanded to address extensions needed under
extraordinary circumstances. The grammar used in describing procedures
for requesting an extension was revised.
The applicability of Health Insurance Portability and
Accountability Act (HIPAA) privacy protections have been explained,
along with clarification that changes in the status of the program
sponsor or medical director must be submitted to SAMHSA in writing. The
chapter of the Controlled Substances Act with which OTPs are expected
to comply has been added; the chapter number is not included in the
current version of the rule.
The conditions for approval of interim treatment have been amended
to increase the duration of interim treatment from 120 days to 180
days, with the stipulation that individuals shall not be discharged
without the approval of an OTP practitioner while awaiting transfer to
a comprehensive treatment program. A reference to section 1923 of the
Public Health Service Act (21 U.S.C. 300x-23) is removed. The proposed
rule also shifts the need to seek approval from the `chief public
health officer' of the state in which the OTP operates to the State
Opioid Treatment Authority in the state in which the OTP operates.
The services that can be provided in medication units have been
clarified to explicitly allow the full range of OTP services, based on
space and privacy available in the medication unit.
8. Section 8.12--Federal Opioid Use Disorder Treatment Standards.
Revisions of treatment standards incorporated in this section aim
to improve access to treatment, improve patient satisfaction and
engagement in services and support use of clinical judgment in
decision-making. In several instances, stigmatizing language such as
``legitimate treatment use'' of controlled substances, has been removed
and patient-centered language is added.
The paragraph on staff credentials is amended to expand the
definition of ``qualifying practitioners'' to a ``physician, physician
assistant, nurse practitioner, clinical nurse specialist, certified
registered nurse anesthetist, or certified nurse midwife who is
appropriately licensed by a State to prescribe covered medications and
who possesses a waiver under 21 U.S.C. 823(g)(2).'' The expectation
that all licensed and credentialed staff maintain

[[Page 77333]]

licensure and/or certification has been added.
Criteria for admission to treatment removes reference to the
Diagnostic and Statistical Manual of Mental Disorders (DSM) IV and
eliminates the requirement for a one-year history of OUD. The proposed
rule instead specifies that the individual should either: meet
diagnostic criteria for active moderate to severe OUD; that the
individual may be in OUD remission; or at high risk for recurrence or
overdose. The section is amended to assure that the basis for the
admission decision is documented in the patient's record. In
recognition of the use of telehealth and its limitation in obtaining
physical signatures, the requirement to obtain written patient consent
to treatment is removed. Consent may be provided verbally or
electronically, and documented as such. The requirement that
individuals under age 18 have two documented unsuccessful attempts at
short term withdrawal management (``detoxification'') or drug free
treatment is also amended to allow consent of a parent, legal guardian,
or responsible adult. Further to this, the rule requiring a 1-year
history of OUD for people recently released from penal institutions,
pregnant patients or previously enrolled individuals has been removed.
Throughout the document, ``detoxification'' and the corresponding
definition and standards for short-and long-term detoxification
treatment have been removed. ``Withdrawal management'' and terms for
tapering from MOUD are added on behalf of individuals who seek this
approach or who elect or need to reduce and/or discontinue MOUD.
The ``Required services'' paragraph is revised to incorporate
patient-centered language, establish flexible terminology, promote use
of clinical judgment, and clarify SAMHSA's expectations of OTPs. The
proposed rule creates the requirement that services be available that
meet patient needs, and ``shared decision making'' is added as the
method to be used in developing care plans.
The paragraph describing the initial medical examination has been
amended to clarify the terms ``screening'' medical exam and
``comprehensive examination'', while also expanding the qualifications
of practitioners able to complete such examinations. These include
practitioners outside of the OTP (with limitations and specific
instructions). The proposed rule also creates criteria for lab testing
conducted prior to a screening medical exam, as well as a permissible
timeframe. The use of telehealth in undertaking the screening medical
exam and initiation of MOUD has also been addressed in the proposed
rule. Additionally, the paragraph on special services for pregnant
people is amended to specify that confirmation of pregnancy is required
for priority treatment admissions. The option to use split dosing for
patients is also added.
The components of initial and periodic medical examinations have
been expanded in the proposed rule to incorporate assessment of
behavioral health, risk of self-harm or harm to others, and to specify
time frames for completion of the care plan. Areas of psychosocial
assessment are amended so as to assure information is gathered on the
context of the patient's whole life such as their mental health,
housing, recovery support and harm reduction resources. Additionally,
patient-centered language has been added, such as ``services a patient
needs and wishes to pursue''.
The proposed rule expands the definition of `counseling services'
to include psychoeducational services, harm reduction and recovery-
oriented services, and counseling and linkage to treatment for anyone
with positive test results on human immunodeficiency virus (HIV), viral
hepatitis, and other sexually transmitted infection (STI) panels, or
from OTP-provided medical examinations. Language about services that
must be provided directly or through referral is revised to promote a
patient-centered approach to care that does not make medication
continuity contingent upon involvement in counseling services but
fosters shared decision-making for all care plans.
The requirement that an OTP have a formal documented agreement with
outside agencies is amended to remove the word ``formal''; the proposed
rule calls for a ``documented agreement'' to provide such services.
Language that addresses drug testing services has been amended to
remove stigmatizing phrases, such as ``drug abuse'', and to remove
content on short-term withdrawal management (``detoxification'').
Further to this, the requirement to use drug tests that have received
the FDA's marketing authorization was added.
Rules that address recordkeeping and efforts to avoid simultaneous
enrollment in multiple OTPs are amended to be more declarative, such as
changing the word ``review'' to ``determine'' whether or not a patient
is enrolled in another OTP, and documenting review efforts in the
patient's record to demonstrate the good faith efforts made. The
proposed rule also expands the circumstances in which a patient may
obtain treatment at another OTP to include instances when there is an
inability to access care at the OTP of record.
Specification of disciplines authorized to administer or dispense
MOUD is removed from the rule. LAAM, also known as Levacetylmethadol,
is removed from the list of treatment medications because it is no
longer available, and other medications approved since prior revisions
to this rule were added. The regulation of an initial dose of methadone
remains at 30mg, not to exceed 40mg on the first day, with the
incorporation of a provision for higher doses if clinically indicated
and documented in the patient's record. The rule to ensure
documentation of any significant deviation from FDA-approved labeling
has been maintained in the proposed rule, while redundant language was
removed.
Rules on the provision of unsupervised (or take home) doses of
methadone are substantially amended to incorporate flexibilities issued
in response to the COVID-19 pandemic. Stigmatizing language is removed,
and the criteria for decision-making is reframed to promote use of
clinical judgement and patient-centered care. In general, the revised
criteria allow up to 7 days of take home doses during the first 14 days
of treatment, up to 14 take home doses from 15 days of treatment and up
to 28 take home doses from 31 days in treatment. The requirement that
OTPs maintain procedures to protect take homes from theft and diversion
was continued, and patient education on safe transport and storage of
take home doses is added, including documentation of the provision of
this education in the patient's clinical record.
Consistent with the conditions for approval of interim treatment,
the proposed rule extends the potential duration of interim treatment
from 120 days to 180 days. It also clarifies the circumstances in which
interim treatment may apply and maintains priority access to
comprehensive services for pregnant individuals. The proposed rule
removes the requirement for observation of all daily doses during
interim treatment. It clarifies the expectation that crisis services
and information pertaining to locally available, community-based
resources for ancillary services be made available to individual
patients in interim treatment. A requirement of a plan for continuing
treatment beyond 180 days of interim services was added to the proposed
rule.

[[Page 77334]]

9. Section 8.13--Revocation of Accreditation and Accreditation Body
Approval.
Changes in this section were limited to referring to an OTP as a
``program'' instead of a ``facility''.
10. Section 8.14--Suspension or Revocation of Certification.
This section refines steps SAMHSA may take when immediate action is
necessary to protect public health or safety.
11. Subpart D--Procedures for Review of Suspension or Proposed
Revocation of OTP Certification, and of Adverse Action Regarding
Withdrawal of Approval of an Accreditation Body.
Language referencing ``treatment program'' in this section was
changed to ``OTP'' for document consistency.
12. Subpart F--Authorization To Increase Patient Limit to 275 Patients.
This subpart has been amended to change the format from the prior
Question-and-Answer style to a standard format.
13. Section 8.610--Practitioner Eligibility Requirements for a 3-Year
275-Patient Limit.
Modernized language to refer to MOUD and to remove stigmatizing
language that referred to `legitimate medications'. The proposed rule
also clarified that the 275-patient waiver is limited to three years in
duration, requiring renewal.
14. Section 8.635--What are the reporting requirements for
practitioners whose 275 request for patient limit is approved?
The proposed rule removes reporting requirements for practitioners
approved to treat up to 275 patients, eliminating Sec. 8.635 in its
entirety.

Background and Need for Proposed Rule

As of June 2022 there are over 1,920 OTPs in the United States,
providing care to over 650,000 patients. These are the only settings
within which methadone, a schedule II opioid receptor agonist, can be
legally provided to people with OUD outside the context of hospital
admission or certain other special circumstances.\14\
---------------------------------------------------------------------------

\14\ See 21 CFR 1306.07.
---------------------------------------------------------------------------

An OTP is an accredited treatment program with SAMHSA certification
and Drug Enforcement Administration (DEA) registration to administer
and dispense opioid agonist medications that are approved by FDA to
treat OUD. Currently, these include methadone and buprenorphine, a
schedule III partial opioid receptor agonist. Other pharmacotherapies,
such as naltrexone, may be provided but are not subject to regulations
under part 8. For purposes of certification, OTPs must also provide
adequate medical, counseling, vocational, educational, and other
assessment and treatment services either onsite or by referral to an
outside agency or practitioner.\15\ Buprenorphine can also be dispensed
(including by prescribing) to treat OUD by eligible practitioners with
a waiver under 21 U.S.C. 823(g)(2) in settings outside of OTPs given
its different scheduling and treatment under the Controlled Substances
Act.\16\
---------------------------------------------------------------------------

\15\ Substance Abuse and Mental Health Services Administration.
(2015). Federal guidelines for opioid treatment programs. HHS
Publication No. (SMA) PEP15-FEDGUIDEOTP. Rockville, MD: Substance
Abuse and Mental Health Services Administration.
\16\ 21 U.S.C. 823(g)(2); Substance Abuse and Mental Health
Services Administration. Medications for Opioid Use Disorder.
Treatment Improvement Protocol (TIP) Series 63 Publication No.
PEP21-02-01-002. Rockville, MD: Substance Abuse and Mental Health
Services Administration, 2021.
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Practitioners treating OUD and the OTPs in which they practice must
continuously adapt to evolving patterns of drug misuse. Over the past
40 years, this has been complicated by rapid changes in prescribing
practices, supply chains and patterns of drug use. Indeed, the early
opioid epidemic of the 1990s was characterized by an increased supply
of prescription opioids.\17\ By 2010, however, the U.S. began to see
rapid increases in overdose deaths involving heroin \18\ and then by
2013, synthetic opioids other than methadone--primarily illicitly
manufactured fentanyl--contributed to a further rise in overdose-
related deaths.19 20
---------------------------------------------------------------------------

\17\ Centers for Disease Control and Prevention (CDC). Vital
signs: overdoses of prescription opioid pain relievers--United
States, 1999-2008. MMWR MorbMortal Wkly Rep. 2011 Nov 4;
60(43):1487-1492.
\18\ Rudd RA, Paulozzi LJ, Bauer MJ, Burleson RW, Carlson RE,
Dao D, Davis JW, Dudek J, Eichler BA, Fernandes JC, Fondario A.
Increases in heroin overdose deaths--28 states, 2010 to 2012.MMWR
MorbMortal Wkly Rep. 2014 Oct 3; 63(39):849.
\19\ Gladden RM, Martinez P, Seth P. Fentanyl law enforcement
submissions and increases in synthetic opioid-involved overdose
deaths--27 states, 2013-2014. MMWR MorbMortal Wkly Rep. 2016;
65:837-43.
\20\ O'Donnell JK, Gladden RM, Seth P. Trends in deaths
involving heroin and synthetic opioids excluding methadone, and law
enforcement drug product reports, by census region--United States,
2006-2015. MMWR MorbMortal Wkly Rep. 2017; 66:897-903.
---------------------------------------------------------------------------

The isolation, anxiety and reduced access to resources experienced
by many during the COVID-19 pandemic has exacerbated substance misuse
and overdose deaths. According to provisional data from the Centers for
Disease Control and Prevention (CDC), a predicted 107,375 Americans
died from a drug overdose in the 12-month period ending in January
2022.\21\ Synthetic opioids (primarily illicitly manufactured fentanyl)
appear to be the principal driver of overdose deaths, increasing 55
percent from 2019 to 2020 and further increasing 26 percent from 2020
to 2021.\22\ Overdose deaths involving cocaine also increased by 22
percent from 2019 to 2020. These deaths are likely linked to co-use or
mixing (by illicit producers) of cocaine with illicitly manufactured
fentanyl or heroin.\23\ The rise in fentanyl use or exposure,
concurrent substance misuse, as well as overdose deaths, necessitates
changes to part 8 that expand access to care, and promote engagement in
OTP services, while also maintaining oversight and accreditation
activities. Oversight and accreditation standards are supported as a
means of promoting evidence-based care, while minimizing diversion and
also adverse patient outcomes.
---------------------------------------------------------------------------

\21\ Ahmad, F.B., Rossen, L.M., Sutton, P. (2021). Provisional
drug overdose death counts. National Center for Health Statistics.
\22\ Wide-ranging online data for epidemiologic research
(WONDER). Atlanta, GA: CDC, National Center for Health Statistics;
2022. Available at <a href="https://wonder.cdc.gov">https://wonder.cdc.gov</a>.
\23\ Ibid.
---------------------------------------------------------------------------

A. Regulatory Background

On January 17, 2001 (66 FR 4075), the Department issued final
regulations for the use of opioid agonist medications (referred to as
narcotic drugs) in treatment and withdrawal management (referred to as
detoxification) of OUD. The final rule repealed the treatment
regulations enforced by the FDA, and created a new regulatory system
based on an accreditation model. In addition, the final rule shifted
administrative responsibility and oversight from the FDA to SAMHSA.
This rulemaking initiative followed a study by the Institute of
Medicine (IOM) (now known as the National Academy of Medicine) and
reflected recommendations by the IOM and several other entities to
improve the treatment of OUD by allowing for increased medical judgment
in the care of patients with OUD. Since publication of the final rule
in 2001, it has been updated to include new medications, such as
buprenorphine, while also updating or adding new rules governing the
provision of such medications.
Between 1972 and 2001, Federal regulatory oversight of OTPs was

[[Page 77335]]

enforced by the FDA before responsibility for oversight was transferred
to SAMHSA. Periodic reviews, studies, and reports on the Federal
oversight system culminated with the 1995 IOM Report entitled Federal
Regulation of Methadone Treatment.\24\ The IOM report recommended that
the FDA process-oriented regulations should be reduced in scope to
allow more clinical judgment in treatment and greater reliance on
guidelines. The IOM report also recommended designing a single
inspection format, having multiple elements, that would (1) provide for
consolidated, comprehensive inspections conducted by one agency (under
a delegation of Federal authority, if necessary), which serves all
agencies (Federal, State, local) and (2) improve the efficiency of the
provision of methadone services by reducing the number of inspections
and consolidating their purposes.
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\24\ For full text, see: <a href="https://www.ncbi.nlm.nih.gov/books/NBK232108/">https://www.ncbi.nlm.nih.gov/books/NBK232108/</a>.
---------------------------------------------------------------------------

To address these recommendations, SAMHSA proposed a
``certification'' system based on accreditation. Under the system, an
applicant who intended to dispense opioid agonist medications in the
treatment of OUD must first obtain from SAMHSA, a certification that
the applicant is qualified under the Secretary's standards and will
comply with such standards. Eligibility for certification depended upon
the applicant obtaining accreditation from a private nonprofit entity,
or from a State agency, that had been approved by SAMHSA to accredit
OTPs.
Accreditation bodies were directed to base accreditation decisions
on a review of an application for accreditation and on surveys (onsite
inspections) conducted every three years by OUD treatment experts. In
addition, accreditation bodies must apply specific opioid treatment
accreditation elements that reflect ``state-of-the-art'' opioid
treatment guidelines. Further to this, accreditation standards required
that OTPs have quality assurance systems that consider patient
outcomes.
The 2001 final regulations replaced FDA `approval' of programs,
with direct government inspection in accordance with more detailed
process-oriented regulations. These process-oriented regulations
continue to prescribe many aspects of oversight and treatment. To this
end, subpart B of the regulation addresses accreditation and includes
steps that accreditation bodies must follow to achieve approval to
accredit OTPs. It also sets forth the accreditation bodies'
responsibilities, including the use of accreditation elements during
accreditation surveys. Subpart C describes the sequence and
requirements for obtaining certification, and addresses how and when
programs must apply for initial certification and renewal of their
certification. Subpart D elucidates the procedures for review of the
withdrawal of approval of the accreditation body or the suspension and
proposed revocation of an OTP certification. Subpart F, added in 2016,
describes criteria for increasing the patient limit for those meeting
Federal requirements to prescribe buprenorphine to 275.\25\
---------------------------------------------------------------------------

\25\ See <a href="https://www.federalregister.gov/documents/2016/07/08/2016-16120/medication-assisted-treatment-for-opioid-use-disorders">https://www.federalregister.gov/documents/2016/07/08/2016-16120/medication-assisted-treatment-for-opioid-use-disorders</a>.
---------------------------------------------------------------------------

In 2001 there were close to 900 OTPs, but that number has grown to
over 1900 by 2022.\26\ Over this period of time, the incidence of
fentanyl misuse has increased, escalating with the onset of the COVID-
19 public health emergency in early 2020. To protect the public's
health and reduce the risk of COVID-19 infection among patients and
providers, SAMHSA issued flexibilities in the provision of unsupervised
doses of methadone and also initiation of buprenorphine via telehealth,
that allowed for continued treatment of OUD with reduced direct patient
contact. Each of these flexibilities represented a significant change
to treatment standards, and are discussed in detail below.
---------------------------------------------------------------------------

\26\ SAMHSA treatment locator. See <a href="https://dpt2.samhsa.gov/treatment/directory.aspx">https://dpt2.samhsa.gov/treatment/directory.aspx</a>.
---------------------------------------------------------------------------

Flexibility for Methadone Medication Take Homes in Opioid Treatment
Programs

Among the existing standards for medication administration and
dispensing of methadone are limitations on unsupervised or ``take
home'' use. These prior standards were established early in the history
of methadone as a medication for OUD, and the criteria for determining
whether a patient may be allowed take homes were restrictive, requiring
daily visits to the OTP for extended periods of time, and adherence to
strict measures of sustained stability as described in 42 CFR part
8.\27\ These criteria can pose disruption to employment and daily
activities for patients, and several of the criteria reflect outdated
biases that promote stigma and discourage people from engaging in care
in OTPs.
---------------------------------------------------------------------------

\27\ <a href="https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-8?toc=1">https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-8?toc=1</a>.
---------------------------------------------------------------------------

In March 2020, as a result of the pandemic, SAMHSA issued
exemptions that allowed state regulatory authorities to request blanket
exceptions to allow patients to take home more doses of methadone; 43
states and the District of Columbia did so.\28\ With this flexibility,
SAMHSA allowed OTPs to dispense 28 days of ``take home'' methadone
doses to ``stable'' patients for the treatment of OUD, and up to 14
doses of ``take home'' methadone for ``less stable'' patients ``who the
OTP believes can safely handle this level of take home medication.''
\29\ Although the duration of this flexibility was not initially
specified, a SAMHSA FAQ published in April 2020, indicated that the
flexibility was tied with the duration of ``the current national health
emergency . . . .'' \30\
---------------------------------------------------------------------------

\28\ HHS Guidance for Opioid Treatment Programs. <a href="https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf">https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf</a>.
\29\ See <a href="https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf">https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf</a>.
\30\ See <a href="https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf">https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf</a>.
---------------------------------------------------------------------------

The intention of the methadone take home flexibility was to reduce
the risk of COVID-19 infection among patients and providers. Beyond
this, the flexibility promotes individualized care that considers
patient characteristics and program involvement beyond time in
treatment. By reducing the burden on patients to visit the OTP daily,
this flexibility could reduce stigma for those seeking treatment, while
also providing more equitable access to care as telemedicine in OTPs is
expanded. It also allows those who reside far from an OTP or who lack
access to reliable transportation to receive treatment, while also
being able to gain or maintain employment, care for loved ones and
engage in other required activities of daily living.
The methadone take home flexibility has been met with widespread
support among patients,\31\ OTPs,\32\ and state authorities.\33\
Patients reported that increased take home doses of methadone left them
feeling more respected as responsible individuals.\31\ In a recent
meeting, state authorities reported that the flexibilities were
appreciated by patients and OTPs alike,

[[Page 77336]]

with no significant change in rates of diversion seen since the COVID-
19 PHE was declared. Indeed, analysis of the relevant data indicates
that the actual level of misuse, diversion or harm from methadone is
more likely to occur when it is prescribed for pain as opposed to OUD,
and that the rate of diversion is lower than that of oxycodone or
hydrocodone.\34\ Additionally, a recent survey found that diversion of
methadone is low among patients receiving take home doses under the
COVID-19 PHE flexibility.35 36 Further to this, analysis of
data on fatal overdoses from January 2019 to August 2021 demonstrated
that this flexibility did not lead to more deaths involving
methadone.\37\
---------------------------------------------------------------------------

\31\ Hatch-Maillette MA, Peavy KM, Tsui JI, Banta-Green CJ,
Woolworth S, Grekin P. Re-thinking patient stability for methadone
in opioid treatment programs during a global pandemic: Provider
perspectives. J Subst Abuse Treat. 2021 May;124:108223. doi:
10.1016/j.jsat.2020.108223. Epub 2020 Dec 5. PMID: 33342667; PMCID:
PMC8005420.
\32\ Joseph G, Torres-Lockhart K, Stein MR, Mund PA, Nahvi S.
Reimagining patient-centered care in opioid treatment programs:
Lessons from the Bronx during COVID-19. J Subst Abuse Treat. 2021
Mar;122:108219. doi: 10.1016/j.jsat.2020.108219. Epub 2020 Dec 3.
PMID: 33353790; PMCID: PMC7833302.
\33\ ``To Save Lives From Opioid Overdose Deaths, Bring
Methadone Into Mainstream Medicine'', Health Affairs Forefront, May
27, 2022.
\34\ National Institute on Drug Abuse (NIDA). 2018, June.
Medications to Treat Opioid Use Disorder. Retrieved from <a href="https://irp.drugabuse.gov/wp-content/uploads/2019/12/NIDA-Medications-to-treat-opioid-use-disorder_2018.pdf">https://irp.drugabuse.gov/wp-content/uploads/2019/12/NIDA-Medications-to-treat-opioid-use-disorder_2018.pdf</a>.
\35\ Figgatt, MC, Salazar Z, Day E, Vincent L, Dasgupta N. Take-
home dosing experiences among persons receiving methadone
maintenance treatment during COVID-19, Journal of Substance Abuse
Treatment, Volume 123, 2021, <a href="https://doi.org/10.1016/j.jsat.2021.108276">https://doi.org/10.1016/j.jsat.2021.108276</a>.
\36\ Dooling, B.C.E. & Stanley, L.E. (2021). Unsupervised use of
opioid treatment medications: Report II of the extending pandemic
flexibilities for opioid use disorder treatment project. GW
Regulatory Studies Center. <a href="https://regulatorystudies.columbian.gwu.edu/unsupervised-use-opioid-treatment-medications">https://regulatorystudies.columbian.gwu.edu/unsupervised-use-opioid-treatment-medications</a>.
\37\ Jones, C. M., Compton, W. M., Han, B., Baldwin, G., &
Volkow, N. D. (2022). Methadone-Involved Overdose Deaths in the US
Before and After Federal Policy Changes Expanding Take-Home
Methadone Doses From Opioid Treatment Programs. JAMA psychiatry,
e221776. Advance online publication. <a href="https://doi.org/10.1001/jamapsychiatry.2022.1776">https://doi.org/10.1001/jamapsychiatry.2022.1776</a>.
---------------------------------------------------------------------------

Recognizing the importance of this flexibility, SAMHSA released
guidance on November 18, 2021, that extended the methadone take home
flexibility for one year past the end of COVID PHE. This was to
accommodate the rule making process that proposes to make this
flexibility permanent. In this proposed rule, SAMHSA has reviewed and
updated criteria used to determine eligibility for take home doses of
methadone, while also promoting shared decision making that is
supported by availability of unsupervised doses of methadone from entry
into treatment. Individuals receiving take home doses of methadone are
supported through individually tailored telehealth visits to
practitioners, counselors and other services as indicated. Further to
this, the proposed changes highlight practitioner autonomy in
determining eligibility for unsupervised doses of methadone. This is a
significant change to treatment standards, but it is grounded in
evidence that demonstrates the safety and efficacy of promoting patient
and provider autonomy.

The Opioid Treatment Program Flexibility To Prescribe MOUD via
Telehealth Without an Initial In-Person Physical Evaluation

Telehealth is a mode of service delivery that has been used in
clinical settings for over 60 years and empirically studied for just
over 20 years. 38 39 40 Between 2016 and 2019, use of
telehealth, in general, doubled from 14 to 28 percent,\41\ while
substance use disorder (SUD) treatment, offered through telehealth over
the same period, increased from 13.5 to 17.4 percent.\42\ This trend
has rapidly increased between 2019 and 2021, due to the COVID-19
pandemic.\43\
---------------------------------------------------------------------------

\38\ Bashshur, R.L., Shannon, G.W., Bashshur, N., & Yellowlees,
P.M. (2016). The empirical evidence for telemedicine interventions
in mental disorders. Telemedicine and e-Health, 22(2), 87-113.
\39\ Lustig, T. (2012). The role of telehealth in an evolving
health care environment: Workshop summary. National Academies Press.
\40\ Mace, S., Boccanelli, A., & Dormond, M. (2018). The use of
telehealth within behavioral health settings: Utilization,
opportunities, and challenges. University of Michigan School of
Public Health, Behavioral Health Workforce Research Center.
\41\ American Medical Association (2019). Telehealth
implementation playbook. Digital Health Implementation Playbook
Series. <a href="https://www.ama-assn.org/system/files/2020-04/ama-telehealthimplementation-playbook.pdf">https://www.ama-assn.org/system/files/2020-04/ama-telehealthimplementation-playbook.pdf</a>.
\42\ Uscher-Pines, L., Cantor, J., Huskamp, H.A., Mehrotra, A.,
Busch, A., & Barnett, M. (2020). Adoption of telemedicine services
by substance abuse treatment facilities in the U.S. Journal of
Substance Abuse Treatment, 117, 108060.
\43\ Melamed OC, deRuiter WK, Buckley L, Selby P. Coronavirus
Disease 2019 and the Impact on Substance Use Disorder Treatments.
Psychiatr Clin North Am. 2022 Mar;45(1):95-107. doi: 10.1016/
j.psc.2021.11.006. Epub 2021 Nov 12. PMID: 35219445; PMCID:
PMC8585604.
---------------------------------------------------------------------------

The pandemic spurred use of telemedicine for the treatment of OUD
using buprenorphine, a schedule III partial opioid receptor agonist.
Prior to buprenorphine's development, the only opioid agonist that
could be used to treat OUD was methadone dispensed through OTPs.
Methadone has a relatively complicated pharmacological profile,
necessitating closer observation of new patients to ensure that initial
doses do not exceed an individual's tolerance for the medication. The
Drug Addiction Treatment Act of 2000 (DATA 2000) allowed practitioners
to treat OUD outside of OTPs using buprenorphine, generally with an
initial in-person medical evaluation before prescribing.
On March 16, 2020, the Secretary of HHS, with the concurrence of
the Acting DEA Administrator, designated that the telemedicine
exception under 21 U.S.C. 802(54)(D), applied to all schedule II-V
controlled substances.\44\ Accordingly, DEA-registered, DATA-Waived
practitioners may issue buprenorphine prescriptions through
telemedicine to new patients for whom they have not conducted an in-
person medical evaluation, provided certain conditions are met during
the COVID-19 public health emergency.
---------------------------------------------------------------------------

\44\ See <a href="https://www.deadiversion.usdoj.gov/coronavirus.html">https://www.deadiversion.usdoj.gov/coronavirus.html</a>.
---------------------------------------------------------------------------

On March 25, 2020, the DEA also granted a ``temporary exception''
to its regulations that allows practitioners to prescribe controlled
medications in states in which they are not registered, if the
practitioner is registered with the DEA in at least one state and is
authorized by both the state where the practitioner is registered with
DEA and the state where the dispensing occurs.\45\ According to the
DEA, practitioners may utilize this temporary exception via in-person
prescribing or prescribing via telemedicine. The DEA also specified
that this exception is granted through ``the duration of the COVID-19
public health emergency as declared by the Secretary of Health and
Human Services.'' \46\
---------------------------------------------------------------------------

\45\ See Exception to Separate Registration Requirements Across
State Lines (DEA067), <a href="https://www.deadiversion.usdoj.gov/GDP/">https://www.deadiversion.usdoj.gov/GDP/</a>(DEA-
DC-018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf.
\46\ With respect to methadone delivery, during the COVID-19
public health emergency, the DEA has also authorized employees of
OTPs to personally deliver methadone to patients who otherwise
cannot travel to the OTP, and has issued a waiver to permit law
enforcement and National Guard personnel to deliver methadone
directly to patients of OTPs. See <a href="https://www.deadiversion.usdoj.gov/faq/coronavirus_faq.htm#NTP_FAQ">https://www.deadiversion.usdoj.gov/faq/coronavirus_faq.htm#NTP_FAQ</a>.
---------------------------------------------------------------------------

Building upon this, SAMHSA implemented OTP regulatory flexibilities
designed to help address the impact of the COVID-19 pandemic on OTPs
and their patients.\47\ In April 2020, SAMHSA exempted OTPs from the
requirement to perform an in-person physical evaluation (under 42 CFR
8.12(f)(2)) for any patient who will be treated by the OTP with
buprenorphine if a program physician, primary care physician, or an
authorized healthcare professional under the supervision of a program
physician, determines that an adequate evaluation of the patient can be
accomplished via telehealth. The duration of this exemption was
specifically tied with the ``period of the national emergency declared
in response to the COVID-19 pandemic'',\48\ and the exemption did not
include

[[Page 77337]]

induction of methadone via telehealth technology.
---------------------------------------------------------------------------

\47\ OTPs are authorized to dispense narcotic maintenance and
detoxification medication under 21 U.S.C. 823(g)(1) and regulated
under 42 CFR part 8.
\48\ See <a href="https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf">https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf</a>.
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Recent research has demonstrated that telehealth can be an
effective tool in integrating care and extending the reach of specialty
providers,\49\ and that among those requiring treatment with
buprenorphine, there are high levels of satisfaction with the use of
telehealth services.\50\ Additionally, there are no significant
differences between telehealth and in-person buprenorphine induction in
the rate of continued substance use, retention in treatment or
engagement in services.38 51 Research also shows that there
is no significant difference in client and provider ratings of
therapeutic alliance when using telehealth technology platforms.\39\
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\49\ Guille, C., Simpson, A.N., Douglas, E., Boyars, L.,
Cristaldi, K., McElligott, J., Johnson, D., & Brady, K. (2020).
Treatment of opioid use disorder in pregnant women via telemedicine:
A nonrandomized controlled trial. JAMA Network Open, 3(1), e1920177-
e1920177.
\50\ King, V.L., Brooner, R. K., Peirce, J.M., Kolodner, K., &
Kidorf, M.S. (2014). A randomized trial of web-based
videoconferencing for substance abuse counseling. Journal of
Substance Abuse Treatment, 46(1), 36-42.
\51\ Vakkalanka, J.P., Lund, B. C., Ward, M.M., Arndt, S.,
Field, R.W., Charlton, M., & Carnahan, R.M. (2022). Telehealth
Utilization Is Associated with Lower Risk of Discontinuation of
Buprenorphine: a Retrospective Cohort Study of US Veterans. Journal
of general internal medicine, 37(7), 1610-1618. <a href="https://doi.org/10.1007/s11606-021-06969-1">https://doi.org/10.1007/s11606-021-06969-1</a>.
---------------------------------------------------------------------------

In the face of an escalating overdose crisis and an increasing need
to reach remote and underserved communities, making the buprenorphine
telehealth flexibility permanent is of paramount importance. The
proposed rule makes permanent criteria of initiation of buprenorphine
via audio-only or audio-visual telehealth technology if an OTP
physician, primary care physician, or an authorized healthcare
professional under the supervision of a program physician, determines
that an adequate evaluation of the patient can be accomplished via
telehealth.
SAMHSA believes that evidence underlying the initiation of
buprenorphine using telehealth translates, to some degree, to the
treatment of OUD with methadone, and warrants expanding access to
methadone therapy by applying some of the buprenorphine in-person
examination flexibilities to treatment with methadone in OTPs.\52\ The
proposed rule allows for the use of audio-visual telehealth for any new
patient who will be treated by the OTP with methadone if a program
physician, or an authorized healthcare professional under the
supervision of a program physician, determines that an adequate
evaluation of the patient can be accomplished via an audio-visual
telehealth platform. SAMHSA is not extending this change to the use of
audio-only telehealth platforms in assessing new patients who will be
treated with methadone because methadone, in comparison to
buprenorphine, holds a higher risk profile for sedation in patients
presenting with mild somnolence which may be easier to identify through
an audio-visual telehealth platform. The proposed rule is not
applicable to, and does not authorize, the prescription of methadone
pursuant to a telehealth visit. Instead, this proposed change applies
to the ordering of methadone by appropriately licensed OTP
practitioners and dispensed to the individual patient by the OTP under
existing OTP procedures.
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\52\ Chan B, Bougatsos C, Priest KC, McCarty D, Grusing S, Chou
R. Opioid treatment programs, telemedicine and COVID-19: A scoping
review. Subst Abus. 2022;43(1):539-546. doi: 10.1080/
08897077.2021.1967836. Epub 2021 Sep 14. PMID: 34520702.
---------------------------------------------------------------------------

Further to this, health care providers who receive Federal
financial assistance are reminded of their obligations to ensure that
their audio-only and audio-visual telehealth platforms are accessible
to individuals with disabilities and afford an opportunity for
meaningful access for limited English proficient (LEP) individuals.
Federal civil rights laws prohibit discrimination on the basis of
disability and may require health care providers to make reasonable
modifications to their policies, practices, or procedures to ensure
that a person who is not able to use an audio-visual telehealth
platforms on the basis of their disability has an equal opportunity to
benefit from treatment with MOUD. Similarly, Federal civil rights laws
that prohibit discrimination on the basis of national origin (including
language ability), require recipients to take reasonable steps to
provide meaningful access to LEP individuals, which may require the
provision of a qualified interpreter and/or translated material, such
that they have the opportunity benefit from treatment with MOUD.

Expanding Access to Services

On June 28, 2021, the DEA introduced requirements for OTPs to add a
``mobile component'' to their existing registration and waived any
obligation for an OTP mobile medication unit complying with these
requirements to separately register at the remote locations where it
dispenses.\53\ On September 21, 2021, SAMHSA released guidance on the
establishment of mobile and non-mobile medication units and allowable
services.\54\ While part 8 currently allows OTPs certified by SAMHSA to
establish medication units (as defined under 42 CFR 8.2), the proposed
rule further defines mobile units and clarifies potential services,
interventions and accreditation processes.
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\53\ See 86 FR 33861; <a href="https://www.federalregister.gov/documents/2021/06/28/2021-13519/registration-requirements-for-narcotic-treatment-programs-with-mobile-components">https://www.federalregister.gov/documents/2021/06/28/2021-13519/registration-requirements-for-narcotic-treatment-programs-with-mobile-components</a>.
\54\ See <a href="https://www.samhsa.gov/medication-assisted-treatment/statutes-regulations-guidelines#mobile">https://www.samhsa.gov/medication-assisted-treatment/statutes-regulations-guidelines#mobile</a>.
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Additionally, the proposed rule defines harm reduction and promotes
expansion of harm reduction services to OTP patients.\55\ The
importance of this has been highlighted during the COVID-19 pandemic,
principally with the CDC and SAMHSA's April 7, 2021, joint announcement
that Federal funding could be used to purchase rapid fentanyl test
strips (FTS).\56\ This was proposed in an effort to help curb the
dramatic spike in drug overdose deaths largely driven by the use (both
intentional and unintentional) of potent synthetic opioids, primarily
illicitly manufactured fentanyl. FTS can be used to determine if drugs
have been mixed or cut with fentanyl, providing people who use drugs
and their communities with important information about fentanyl in the
illicit drug supply so they can take steps to reduce their risk of
overdose. Other important harm reduction activities highlighted in the
proposed rule include: counseling on preventing exposure to, and the
transmission of, HIV, viral hepatitis, and STIs; providing access to
services and treatments for those with HIV, viral hepatitis or an STI;
provision of patient-centered harm reduction education; and
distribution of opioid overdose reversal medications (e.g.,
naloxone).\57\
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\55\ The proposed rule does not permit OTPs to engage in any
activities that would violate Federal, State, or local law.
\56\ See <a href="https://www.cdc.gov/media/releases/2021/p0407-Fentanyl-Test-Strips.html">https://www.cdc.gov/media/releases/2021/p0407-Fentanyl-Test-Strips.html</a>.
\57\ See <a href="https://www.samhsa.gov/blog/new-samhsa-guide-highlights-hiv-prevention-treatment-people-substance-use-andor-mental">https://www.samhsa.gov/blog/new-samhsa-guide-highlights-hiv-prevention-treatment-people-substance-use-andor-mental</a>.
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The need to facilitate access to services has been highlighted
during the COVID-19 pandemic. This is particularly important in the
face of increased exposure to fentanyl. Section 8.12(e)(1) of the
proposed rule eliminates the requirement that a person must have had an
addiction to opioids for one year before admission to treatment and
receipt of OTP services, and permits access to those: who meet
diagnostic criteria for a moderate to severe OUD; individuals with
active

[[Page 77338]]

moderate to severe OUD, or OUD in remission; or those individuals who
are at high risk for overdose or recurrence of use. Admission to the
OTP is contingent upon appropriate informed consent and education, as
well as appropriate documentation of consent in the patient's clinical
record.
These activities are supported, in the proposed rule, through
defining a practitioner (in Sec. 8.2) as being ``a physician,
physician assistant, nurse practitioner, clinical nurse specialist,
certified registered nurse anesthetist, or certified nurse midwife who
is appropriately licensed by a State to prescribe covered medications
and who possesses a waiver under 21 U.S.C. 823(g)(2).'' Further to
this, the proposed rule expands decision making capacity of OTP
practitioners to: admission of patients; the provision of treatment
activities; and service provision. This is supported by the use of
telehealth, described above, and involvement of outside practitioners.
Indeed, Sec. 8.12(f)(2) of the proposed rule allows for the initial
medical examination to be completed by a practitioner external to the
OTP no more than seven days prior to admission, provided that it is
verified by an OTP practitioner. This expands access to OTP services
and is consistent with current medical practice.
In this way, the proposed rule draws on evidence from the COVID-19
pandemic as well as over 20 years of practice-based research. The
proposed rule makes permanent or expands upon flexibilities initiated
during the COVID-19 PHE and recognizes the efficacy and safety of
creating a less restrictive and patient-centered treatment environment.
Further to this, the evidence demonstrates the positive impact of not
requiring frequent patient visits to the OTP. This has been shown to
promote recovery behaviors, such as sustained employment, as well as
support those individuals who live a long distance from the OTP.\58\
The integration of telehealth into the proposed rule further supports
this and allows OTPs flexibility in initiating MOUD.
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\58\ Treitler, P.C., Bowden, C.F., Lloyd, J., Enich, M., Nyaku,
A.N., & Crystal, S. (2022). Perspectives of opioid use disorder
treatment providers during COVID-19: Adapting to flexibilities and
sustaining reforms. Journal of substance abuse treatment, 132,
108514. <a href="https://doi.org/10.1016/j.jsat.2021.108514">https://doi.org/10.1016/j.jsat.2021.108514</a>.
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Section-by-Section Description of Proposed Amendments to 42 CFR Part 8

Below, the Department describes the proposals in this NPRM to amend
42 CFR part 8. The Department believes that the proposed rule expands
access to evidence-based and patient-centered care, limits use of
stigmatizing language, and promotes the practitioner-patient
relationship. These changes are in line with evidence-based practice,
and the Department welcomes feedback on all aspects of the proposed
rule.
In particular, the Department is interested in feedback on the
proposal to increase the allowable time for interim treatment from 120
days to 180 days. This is intended to accommodate OTPs and states as
they address important issues such as staff shortages. It may also
serve as a way of engaging individuals in care. Such issues underlie
the need for this service approach, and while SAMHSA is working with
other Federal and State agencies to build workforce capacity, the use
of interim treatment adds to the care continuum for people with OUD.
The Department also seeks feedback on other paradigms of care
promoted in the proposed rule. Split-dosing and delivery of services
via telehealth are, for example, evidence-based interventions that
promote patient-centered care. The Department proposes to expand access
to evidence-based treatment through the addition of such practices, and
seeks guidance on the proposed use of these interventions and their
integration into the practice environment.
Also proposed are new criteria to support decision making around
take home doses of methadone. The take home flexibility issued at the
start of the COVID-19 pandemic demonstrated that length of time in
treatment, as well as strict negative toxicology test results were not
central to positive outcomes.\58\ This is reflected in the proposed
rule, and feedback is solicited on the proposed criteria, as well as
the schedule for providing unsupervised doses of methadone.
The Department further requests comment on all proposals described
in the following paragraphs of this NPRM. In addition, the Department
requests comment on all aspects of the Regulatory Impact Analysis,
including the assumptions and estimates about the costs and benefits of
the proposed changes, and the alternatives the Department considered
when developing the proposals in this NPRM.
The Department proposes the following amendments to part 8:

A. Heading

The Department proposes to revise the heading to Medications for
the Treatment of Opioid Use Disorder to reflect current medical
terminology and to remove stigmatizing language. The term `opioid use
disorder' more precisely reflects the diagnosis for which medications
are indicated. Further to this, the terms `maintenance' and
`detoxification' reference outdated terminology that has potentially
hindered adoption of evidence-based treatments for OUD.\59\ The amended
heading reflects current medical terminology and highlights that OUD is
a chronic, treatable condition.
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\59\ NIDA. 2021, November 29. Words Matter--Terms to Use and
Avoid When Talking About Addiction. Retrieved from <a href="https://nida.nih.gov/nidamed-medical-health-professionals/health-professions-education/words-matter-terms-to-use-avoid-when-talking-about-addiction">https://nida.nih.gov/nidamed-medical-health-professionals/health-professions-education/words-matter-terms-to-use-avoid-when-talking-about-addiction</a>.
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B. Subpart A

Subpart A currently addresses accreditation and includes steps that
accreditation bodies will follow to achieve approval to accredit OTPs
under the new rules. It also sets forth the accreditation bodies'
responsibilities, including the use of accreditation elements during
accreditation surveys. In the proposed rule, these specifications are
relocated to subpart B, which still includes Certification of Opioid
Treatment Programs. In this way, subpart A is now limited to the
overview of part 8 and definitions. This improves categorization and
provides clear flow within the proposed rule.

C. Section 8.1--Scope

This section has been revised to reflect modern medical terminology
and to detail updated acronyms. Historically, pharmacological treatment
for opioid use disorder was referred to as ``medication assisted
treatment'' (MAT). There is an increasing movement towards the more
medically accurate term ``medication for opioid use disorder'' (MOUD)
since this precisely describes the medications that are being provided,
carries less stigma, and aligns with treatment approaches to all other
health conditions. Further to this, the term `MAT' implies that these
medications are simply adjuncts to a broader treatment strategy.\60\ In
fact, these medications are one critical element of a comprehensive,
long-term treatment and recovery strategy.\60\ As such, the acronym MAT
has been removed from the proposed rule and replaced with MOUD
throughout. The proposed rule identifies other treatment modalities,
such as counseling, by their individual component names, similar to

[[Page 77339]]

the manner by which elements of other chronic disease care are
described.
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\60\ Substance Abuse and Mental Health Services Administration.
Medications for Opioid Use Disorder. Treatment Improvement Protocol
(TIP) Series 63 Publication No. PEP21-02-01-002. Rockville, MD:
Substance Abuse and Mental Health Services Administration, 2021.
---------------------------------------------------------------------------

D. Section 8.2--Definitions

In the 21 years since part 8 was first published, definitions and
paradigms of care for OUD have changed. In particular, treatment for
OUD has evolved from being prescriptive to multimodal and patient-
centered.\61\ This reflects an understanding that OUD is a chronic
condition \62\ and that to be successful, treatment interventions
should be individualized and include harm reduction and recovery
support services. Further to this, flexibilities expanded under the
COVID-19 PHE demonstrated the safety of telehealth interventions.\63\
Accordingly, telehealth is defined in this section using a standard
definition. The proposed rule updates other definitions to reflect
current evidence and practice in the provision of care in OTPs. This is
seen in an expanded definition of `practitioner'. Patients have
benefitted for years from the care provided by nurse practitioners
(NPs) and physician assistants (PAs) in OTPs, and the proposed rule
expands the definition of practitioner to include a ``physician,
physician assistant, nurse practitioner, clinical nurse specialist,
certified registered nurse anesthetist, or certified nurse midwife.''
Finally, the proposed rule removes the term ``detoxification
treatment'' and replaces it with ``withdrawal management.'' The term
detoxification is customarily called medically supervised withdrawal
management to destigmatize the process and more accurately reflect what
patients undergo, and healthcare practitioners provide, in response to
withdrawal from a variety of substances or medications to which
physiologic tolerance develops.\64\
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\61\ Mark TL, Hinde J, Henretty K, Padwa H, Treiman K. How
Patient Centered Are Addiction Treatment Intake Processes? J Addict
Med. 2021 Apr 1;15(2):134-142. doi: 10.1097/ADM.0000000000000714.
PMID: 32826618.
\62\ Russell HA, Sanders M, Meyer JKV, Loomis E, Mullaney T,
Fiscella K. Increasing Access to Medications for Opioid Use Disorder
in Primary Care: Removing the Training Requirement May Not Be
Enough. J Am Board Fam Med. 2021 Nov-Dec;34(6):1212-1215. doi:
10.3122/jabfm.2021.06.210209. PMID: 34772776.
\63\ Langabeer JR 2nd, Yatsco A, Champagne-Langabeer T.
Telehealth sustains patient engagement in OUD treatment during
COVID-19. J Subst Abuse Treat. 2021 Mar;122:108215. doi: 10.1016/
j.jsat.2020.108215. Epub 2020 Nov 24. PMID: 33248863; PMCID:
PMC7685137.
\64\ Substance Abuse and Mental Health Services Administration.
Medications for Opioid Use Disorder. Treatment Improvement Protocol
(TIP) Series 63 Publication No. PEP21-02-01-002. Rockville, MD:
Substance Abuse and Mental Health Services Administration, 2021.
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E. Section 8.3--Application for Approval as an Accreditation Body

This section adds details of policies and procedures expected of
accreditation bodies for clarity and completeness. In Sec. 8.3(b) the
email address for submission of accreditation body applications is
updated. Changes to Sec. 8.3(b)(6) reflect the expectation that
physicians with experience in managing MOUD are employed by
accreditation bodies to assure appropriate medical standards of care
are established and included in review of OTPs. Further amendments are
incorporated to promote communication between the accreditation bodies
and SAMHSA, and to ensure that accreditation bodies focus on OTP
adherence to 42 CFR part 8. Expectations about training provided for
survey team members are added to promote consistency in OTP reviews
with Federal standards and to reduce the risk of unnecessary and overly
burdensome accreditation activities. Further to this, the proposed rule
also provides for Indian Tribes to apply for approval as an
accreditation body.

F. Section 8.4--Accreditation Body Responsibilities

SAMHSA is responsible for oversight of the accreditation bodies. A
thorough review of its oversight procedures resulted in several
proposed changes to improve processes, to assure documentation of
accreditation decisions, and to establish steps to be taken to assure
OTP adherence to 42 CFR part 8. For example, making records available
to SAMHSA on request is added to assure that SAMHSA can review survey
processes and information, and confirm decisions of survey outcomes.
Other amendments, such as accreditation body policies for training
survey team members, have been added to address concerns regarding
inconsistent application of accreditation standards and regulations.
The documentation and sharing of information regarding conflict or
perceived conflict of interest has been added to ensure any conflict of
interest and action taken by the accreditation body is disclosed to
SAMHSA.

G. Section 8.11--Opioid Treatment Program Certification

The requirements for certification and renewal have been in place
since 2001. Therefore, it is necessary to update these as some
certifications and processes no longer apply. For example,
``transitional certification'' expired as a category in May 2003. Other
revisions have been incorporated based on SAMHSA's 20-years of
experience in OTP certification.
The category of ``provisional'' certification required
clarification as to when provisional certification is available.
Moreover, the current rule only designates three-year certifications
for OTPs, whether the accreditation survey resulted in a ``full'' (3-
year) or ``conditional'' 1-year accreditation status. The proposed rule
establishes the category of ``conditional certification'' to allow an
OTP granted a temporary one-year accreditation to continue treatment
services while the OTP takes steps to address issues identified during
the accreditation process. The current regulation limits extension of
certification status to OTPs with provisional certification only.
Circumstances related to the COVID-19 PHE necessitated expansion of
extensions for renewal of any category of certification.
The expectation that OTPs comply with HIPAA regulations when
applicable is added to emphasize rules that govern practice that have
come into effect since 2001. Documentation of change of sponsors or
medical directors is added to assure written records are available, and
a reference to the applicable chapter of the Controlled Substances Act
for OTPs was added to clarify the DEA regulations to which OTPs must
adhere.
Interim treatment means that on a temporary basis, a patient may
receive services from an OTP, while awaiting access to more
comprehensive treatment services. The extension of interim treatment
approval from 120 days to 180 days is intended to better accommodate
OTPs and states in addressing underlying causes necessitating this
category of treatment, such as staff shortages. This approach may also
serve to engage individuals with OUD who otherwise may not seek care.
Given the significant mortality risk of illicit fentanyl and data
demonstrating reductions in overdose death with methadone treatment,
interim services add an opportunity for low-threshold access to life-
saving services. The expectation that individuals enrolled in interim
treatment shall not be discharged without the approval of an OTP
practitioner is to assure continuity of and engagement in care for the
individual as an interim step to a comprehensive treatment program
where additional services are available. The reference to section 1923
of the Public Health Service Act (PHSA) (42 U.S.C. 300x-23) is removed
because it does not specifically pertain to time in interim treatment.
The proposed rule also changes the need to seek approval

[[Page 77340]]

from the `chief public health officer of the state in which the OTP
operates' to the State Opioid Treatment Authority (SOTA) of the state
in which the OTP operates. This change was made to streamline and
centralize the application process.
An overall goal of these revisions is to expand access to MOUD,
specifically to OTP services. Accordingly, the range of services that
can be provided in medication units has been clarified to improve
access to the services OTPs offer, especially in geographic areas in
which distances are a key barrier to accessing treatment.

H. Section 8.12--Federal Opioid Use Disorder Treatment Standards

OTP regulations currently do not reflect the changes in OUD
treatment standards that have occurred over the past 20 years. The dual
challenges of the COVID-19 pandemic and the evolving opioid overdose
epidemic necessitated review and revision of these regulations.
Significant lessons have been learned from adapting treatment in
response to the need for physical distancing and quarantine, and from
the results of implementing flexibilities for take home doses and use
of telehealth under the COVID-19 PHE.
Overcoming the opioid crisis through the expansion of prevention,
treatment, and recovery support services is a primary priority for
SAMHSA, and SAMHSA seeks to expand access to quality treatment
services, encourage the use of MOUD, and improve engagement and
retention in treatment and recovery support services. Consistent with
that goal, amendments to treatment standards incorporated in this
section are intended to improve access to care and improve patient
satisfaction and engagement in services, while also promoting
flexibility and medical judgment in decision-making to reduce the
burden of patient participation in OTPs.
Changes to the ``Required services'' paragraph incorporate patient-
centered language, and promote flexibility in the use of clinical
judgment. For example, required services are amended to assure that
OTPs meet patient needs, and ``shared decision making'' is added to
ensure that the patient be included in the development and
implementation of their care plan. In several instances, the intent of
standards was not changed, but stigmatizing wording such as
``legitimate treatment use'' of controlled substances has been removed.
These amendments are incorporated as a means of reducing the use of
stigmatizing attitudes, practices and language within OTPs that may
contribute to discrimination and impede access to treatment.\65\
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\65\ See <a href="https://www.justice.gov/opa/pr/justice-department-issues-guidance-protections-people-opioid-use-disorder-under-americans">https://www.justice.gov/opa/pr/justice-department-issues-guidance-protections-people-opioid-use-disorder-under-americans</a>.
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Other revisions in this section are included to ensure alignment
with laws and regulations that have been issued since 2001 and to
emphasize their importance to OTPs. These include HIPAA, the
Comprehensive Addiction and Recovery Act (CARA), and the Substance Use-
Disorder Prevention that Promotes Opioid Recovery and Treatment for
Patients and Communities (SUPPORT) Act. Section 303 of CARA, for
example, expanded the definition of ``qualifying practitioners'' from
physicians to include nurse practitioners and physician assistants who
meet certain criteria; this change has been included in the section on
staff credentials and is in alignment with the professionalization of
SUD treatment services that has occurred over the last 20
years. 66 67
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\66\ Center for Substance Abuse Treatment. Competencies for
Substance Abuse Treatment Clinical Supervisors. Technical Assistance
Publication (TAP) Series 21-A. HHS Publication No. (SMA) 12-4243.
Rockville, MD: Substance Abuse and Mental Health Services
Administration, 2007/2013.
\67\ Center for Substance Abuse Treatment. Clinical Supervision
and Professional Development of the Substance Abuse Counselor.
Treatment Improvement Protocol (TIP) Series 52. HHS Publication No.
(SMA) 144435. Rockville, MD: Substance Abuse and Mental Health
Services Administration, 2009/2014.
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A significant change in OTP access is the removal of the
requirement that patients must have had an addiction to opioids for at
least one year prior to admission for MOUD; this is a vestige of prior
versions of the DSM and has posed a barrier to access to treatment. OUD
includes signs and symptoms that are associated with compulsive,
prolonged use of opioid substances for non-medical purposes, despite
harm and negative consequences to the individual with OUD. Therefore,
the assessment of OUD is refocused, in the proposed rule, to
consideration of problematic patterns of opioid use that are in line
with the current version of the DSM diagnostic categories.\68\ The
proposed rules also recognize the potential for recurrence of OUD in
individuals who have sustained remission and recovery and the high
mortality risk associated with these situations. The revised definition
allows for clinical judgment and consideration of severity of use and
comorbid conditions. The new rules also remove the requirement that
individuals under 18 must have two documented unsuccessful attempts at
treatment within one year to be eligible for MOUD. Except where not
required by state law, parental consent to treatment remains a
requirement for patients under age 18. In recognition of the use of
telehealth and the limitation of obtaining written consent, the
requirement for a written form of consent to treatment was removed for
adult patients.
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\68\ See <a href="https://www.aoaam.org/resources/Documents/Clinical%20Tools/DSM-V%20Criteria%20for%20opioid%20use%20disorder%20.pdf">https://www.aoaam.org/resources/Documents/Clinical%20Tools/DSM-V%20Criteria%20for%20opioid%20use%20disorder%20.pdf</a>.
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Throughout the document, ``detoxification'' and the corresponding
definition and standards for short- and long-term detoxification have
been removed as the word ``detoxification'' is considered a pejorative
term and not accurately reflective of the process of managing or
experiencing the withdrawal associated with substances or medications
to which physiologic tolerance develops. Detoxification is an outdated
term that was used to distinguish opioid dependence from OUD based on
the Narcotic Addiction Treatment Act of 1974 (NATA). Practice-based
evidence and extensive research shows that treatment with MOUD is more
effective than withdrawal management at reducing OUD recurrence and
associated mortality and morbidity risk.\69\ However, it is recognized
that some patients may choose, or need, to taper off MOUD. Therefore,
``withdrawal management'' and terms for tapering from MOUD are included
in the section of the regulations that currently refer to
``detoxification.''
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\69\ Kleber HD. Pharmacologic treatments for opioid dependence:
detoxification and maintenance options. Dialogues Clin Neurosci.
2007;9(4):455-70. doi: 10.31887/DCNS.2007.9.2/hkleber. PMID:
18286804; PMCID: PMC3202507.
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Language used in the current rule about the initial medical
examination required clarification to distinguish between an initial
``screening'' exam and a more comprehensive ``examination.'' For
patients with OUD, initiating MOUD is of utmost importance to suppress
withdrawal, engage the individual in additional services, and improve
retention. The need to improve access to treatment necessitates
expanding the qualifications of those practitioners able to complete
screening examinations. The proposed rule allows practitioners who work
outside of the OTP (with limitations and specific instructions) to
undertake screening. This is likely to reduce delays in diagnosing OUD,
initiating MOUD, and in beginning comprehensive treatment. This section
also improves medical services by setting expectations for lab testing,
establishing time frames for examinations, and incorporating use of

[[Page 77341]]

telehealth. Special services for pregnant people have been revised to
specify that confirmation of pregnancy is required for priority
treatment admissions to prevent misuse of priority status. The option
to use split dosing for patients was added to this section, as well.
Changes to the initial and periodic medical services sections are
intended to promote key issues for OTP medical practitioners and the
OTP multi-disciplinary team to address with a patient as part of
treatment. This includes areas that may increase the risk of a patient
leaving care prematurely, such as unmet mental health or other
disability, medical and oral health needs, the need for culturally
supportive care that addresses race, ethnicity, sexual orientation,
religion or gender identity, and social determinants of health, such as
housing and transportation, that may pose barriers to treatment
engagement, or harm reduction and recovery support service needs.
Patient-centered language was added to ensure that the care provided is
consistent with the patient's needs, and self-identified goals for
treatment and recovery. The time frames for completion of the care plan
are included as a measure of quality. Also included is the requirement
in Sec. 8.12(f)(4)(i) that individuals starting treatment be screened
for imminent risk of harm to self or others. This recognizes that risk
for suicide is increased among individuals who misuse substances \70\
and that appropriate screening, intervention, and referrals for care
are vital to health and engagement in treatment activities.\71\
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\70\ Substance Abuse and Mental Health Services Administration
(2015). Substance Use and Suicide: A Nexus Requiring a Public Health
Approach. In Brief.
\71\ Lynch Fl., Peterson EL, Lu CY, Hu Y, Rossom RC, Waitzfelder
BE, Owen-Smith AA, Hubley S, Parbhakar D, Keoki Williams L, Beck A,
Simon GE, Ahmedani BK. Substance use disorders and risk of suicide
in a general US population: a case control study. Addict Sci Clin
Pract. 2020 Feb 21;15(1):14. doi:10.1186/s13722-020-0181-1. PMID:
32085800; PMCID: PMC7035727.
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Counseling services have been more finely described to align OTP
services with the current paradigm for evidence-based SUD treatment.
This includes the delineation of psychoeducational services, overdose
prevention and other harm reduction counseling, and recovery-oriented
counseling services. Specific counseling on reducing HIV, hepatitis C,
and other STIs, and linkage to treatment for anyone with positive test
results from OTP-provided laboratory testing, was added to improve
quality of care. Language about services that must be provided directly
or through referral has also been revised to infuse a more patient-
centered approach, such as in ``identified and mutually agreed-upon as
beneficial by the patient and program staff,'' rather than the program
staff determining that the patient is ``in need of such services.''
Drug testing services have been revised to remove the stigmatizing
language of ``drug abuse,'' to remove content on short-term withdrawal
management (``detoxification''), and to improve readability. The
requirement for use of drug tests that have received FDA's marketing
authorization was added to assure valid assays are used.
The current regulations require OTPs to review whether a patient is
enrolled in another OTP prior to admission. Simultaneous enrollment in
multiple OTPs risks patients obtaining more medication than is needed.
Good faith efforts to prevent this must be documented. Therefore, the
language regarding verification of non-enrollment changed from
``review'' to ``determine'' in order to ensure that evidence of good
faith efforts is available. This section also expands the circumstances
in which a patient may obtain treatment at another OTP to include
instances when there is an inability to access care at the OTP of
record. Experiences of state and OTP responses to occurrence of natural
disasters gave evidence of the need to incorporate this allowance on
behalf of patients.
In Sec. 8.12(h) (Medication administration, dispensing, and use),
the specific disciplines authorized to administer or dispense MOUD have
been removed to accommodate variations among states regarding
disciplines allowed to provide this service. Among medications used by
OTPs, LAAM has been removed as it has black box warnings and is no
longer commercially available, while other medications approved since
2001 (naltrexone) were added. Although the maximum initial dose of
methadone remains at 30 mg, use of clinical judgment in dose
adjustments is underscored, due to higher opioid tolerance associated
with increasing rates of fentanyl exposure and opioid overdose. Should
30 mg be insufficient to control symptoms of withdrawal, the program
physician or practitioner may increase the dosage, provided that the
rationale for this change is appropriately documented. The requirement
that the program physician be familiar with the most up-to-date product
labeling has been removed as Sec. 8.12(d) requires that each person
engaged in the treatment of OUD must have sufficient education,
training, and experience, or any combination thereof, to enable that
person to perform the assigned functions. This is inclusive of the
expectation that all program medical practitioners maintain familiarity
with the most up-to-date product labeling for the medications they
administer and dispense to patients.
The exemption policies promulgated by SAMHSA in response to COVID-
19 allowed OTPs to provide more take home doses of methadone to
patients on a more rapid schedule than is permitted in the current
regulations. In the two years since implementation, there have been few
reports of overdose or harm related to take homes, misuse, or other
negative consequences of this flexibility. Evidence from multiple
studies has shown that increases in take home doses following the
SAMHSA exemption did not lead to worse treatment outcomes, higher
overdose rates, or diversion of medication, but instead resulted in
increased treatment engagement and improved patient satisfaction with
care.72 73 74 75 There are sufficient studies to conclude
that this exemption has enhanced and encouraged use of and retention in
OTP services; therefore, the proposed rule for unsupervised (take home)
doses fully incorporates the flexibilities for take home medication
issued during the COVID-19 PHE.
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\72\ Figgatt, M.C., Salazar, Z., Day, E., Vincent, L., &
Dasgupta, N. (2021). Take-home dosing experiences among persons
receiving methadone maintenance treatment during COVID-19. Journal
of substance abuse treatment, 123, 108276. <a href="https://doi.org/10.1016/j.jsat.2021.108276">https://doi.org/10.1016/j.jsat.2021.108276</a>.
\73\ Joseph, G., Torres-Lockhart, K., Stein, M.R., Mund, P.A., &
Nahvi, S. (2021). Reimagining patient-centered care in opioid
treatment programs: Lessons from the Bronx during COVID-19. Journal
of substance abuse treatment, 122, 108219. <a href="https://doi.org/10.1016/j.jsat.2020.108219">https://doi.org/10.1016/j.jsat.2020.108219</a>.
\74\ Amram, O., Amiri, S., Panwala, V., Lutz, R., Joudrey, P.J.,
& Socias, E. (2021). The impact of relaxation of methadone take-home
protocols on treatment outcomes in the COVID-19 era. The American
journal of drug and alcohol abuse, 47(6), 722-729. <a href="https://doi.org/10.1080/00952990.2021.1979991">https://doi.org/10.1080/00952990.2021.1979991</a>.
\75\ Brothers S., Viera A., Heimer R. Changes in methadone
program practices and fatal methadone overdose rates in Connecticut
during COVID-19 Journal of Substance Abuse Treatment. 2021
Dec;131:108449. doi: 10.1016/j.jsat.2021.108449. Epub 2021 Apr 29.
PMID: 34098303.
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The proposed rule removes stigmatizing language in favor of person-
centered approaches and person-first terminology. Changes focus on the
well-being of the individual and reframe the criteria for unsupervised
medication from rule-based to clinical judgment-based decisions. When
determining take home medication schedules under the proposed rule,
SAMHSA recommends that the best interest of each patient and the
public's health be taken into consideration, and that clinical
judgement, not rigid rules, determine if the therapeutic benefit of
take home

[[Page 77342]]

medication outweighs the risks to the patient and public health. The
proposed rule is meant to address barriers to care associated with the
requirement for regular clinic attendance while also improving patient
satisfaction and treatment engagement in a manner that also balances
patient and public health safety.
The conditions for interim treatment extend the potential duration
of this approach from 120 days to 180 days. This is based on SAMHSA's
experience and reports from states that the underlying issues which
prompted interim treatment, such as staff shortages, are not easily
resolved in 120 days.76 77 In addition, interim services may
serve as a low-threshold approach to engaging individuals with OUD in
care, particularly in areas where OTPs offering more comprehensive
services are not as readily available. Clarification of language in
this section also ensures that patients in interim treatment have
documented plans for continuation of treatment beyond 180 days, and are
not discharged based on length of time in interim care. The
circumstances in which a patient could receive interim services
required clarification from ``cannot be placed in a public or nonprofit
private program'' to ``if comprehensive services are not readily
available.'' Services to be provided in this category are revised to
assure alignment of quality expectations for interim care between OTPs
and SAMHSA.
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\76\ Sigmon SC. Interim treatment: Bridging delays to opioid
treatment access. Prev Med. 2015;80:32-36. doi:10.1016/
j.ypmed.2015.04.017.
\77\ Oleskowicz TN, Ochalek TA, Peck KR, Badger GJ, Sigmon SC.
Within-subject evaluation of interim buprenorphine treatment during
waitlist delays. Drug Alcohol Depend. 2021 Mar 1;220:108532. doi:
10.1016/j.drugalcdep.2021.108532. Epub 2021 Jan 20. PMID: 33508690;
PMCID: PMC8148627.
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On July 28, 2021, the DEA published a final rule that permits DEA
registrants who are authorized to dispense methadone for OUD to add a
``mobile component'' to their existing registration--waiving any
requirement that mobile medication units of OTPs operating in
compliance with the rule separately register at their remote dispensing
locations (86 FR 33861). This expanded opportunities for OTPs to
provide needed services in remote or underserved areas. Through use of
Substance Abuse Prevention and Treatment Block Grant (SABG) funds,
SAMHSA encouraged OTPs to establish medication units as a means of
making treatment more readily available, especially to those people in
remote, rural, or underserved areas. To further the goal of improving
and expanding access, the range of services that can be provided in
medication units are described in the proposed rule. Such services must
be delivered in accordance with the nondiscrimination provision at 42
U.S.C. 300x-57, which state that: ``No person shall on the ground of
sex (including, in the case of a woman, on the ground that the woman is
pregnant), or on the ground of religion, be excluded from participation
in, be denied the benefits of, or be subjected to discrimination under,
any program or activity funded in whole or in part with funds made
available under section 300x or 300x-21 of this title.''

I. Section 8.14--Suspension or Revocation of Certification

This section clarifies the actions that SAMHSA may take when
immediate intervention is necessary to protect the public's health or
safety. The proposed rule specifies the administrative actions
available to SAMHSA in the event that a program sponsor, or any
employee of an OTP has: been found guilty of misrepresentation in
obtaining certification; failed to comply with the Federal Opioid Use
Disorder treatment standards; failed to comply with reasonable requests
from SAMHSA or from an accreditation body for records; or refused a
reasonable request of a duly designated SAMHSA inspector, DEA
Inspector, State Inspector, or accreditation body representative for
permission to inspect the program or the program's operations or its
records.

J. Subpart F--Authorization To Increase Patient Limit to 275 Patients

This subpart is amended to change the format from a Question-and-
Answer style to a standard narrative text format. This is for
consistency with the format found throughout the proposed rule.

K. Section 8.610--Practitioner Eligibility Requirements for a 3-Year
275-Patient Limit

This section clarifies the 3-year limit to the 275-patient limit.

L. Section 8.635--What are the reporting requirements for practitioners
whose 275 request for patient limit is approved?

As of May 2022, there were 8,641 practitioners waivered at the 275-
level and of these, 5,905 were Doctors of Medicine and Doctors of
Osteopathic Medicine (MD/DOs). The proposed rule removes reporting
requirements for practitioners at this level. Practitioners have found
the submission of these reports to be burdensome and a disincentive to
treating a higher number of patients.\78\ As increasing numbers of
Americans lose their lives to overdose, it is essential to support
practitioners and to remove perceived disincentives or barriers to
treating more patients. In this way, the extent of the overdose crisis
as a result of the COVID-19 PHE outweighs the potential value of data
obtained from compliant reporters. The proposed rule removes reporting
requirements for those who are authorized to treat up to 275 patients
with buprenorphine. Rather than expect practitioners to submit reports,
SAMHSA will seek to work in partnership with other Federal agencies for
monitoring purposes.
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\78\ Lanham, H.J., Papac, J., Olmos, D.I., Heydemann, E.L.,
Simonetti, N., Schmidt, S., & Potter, J.S. (2022). Survey of
Barriers and Facilitators to Prescribing Buprenorphine and Clinician
Perceptions on the Drug Addiction Treatment Act of 2000 Waiver. JAMA
network open, 5(5), e2212419. <a href="https://doi.org/10.1001/jamanetworkopen.2022.12419">https://doi.org/10.1001/jamanetworkopen.2022.12419</a>.
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Further to this, reporting requirements are known to perpetuate
stigma towards MOUD and to potentially reduce prescribing of a life-
saving medication.\79\ Negative attitudes and beliefs toward use of
medications in treating OUD is common among healthcare professionals,
members of law enforcement and others in justice settings, in the wider
community, and even among persons with OUD themselves.\80\ Of primary
care physicians in a national survey, just over three quarters (77.5%)
perceived buprenorphine to be an effective treatment for OUD.\81\ Many
treatment programs and support groups discourage participants from
using medications, including MOUD.\82\ Young adults with OUD experience
difficulties obtaining or remaining on buprenorphine as a result of
stigma from healthcare providers, 12-step programs, residential
treatment programs, and

[[Page 77343]]

parents.\83\ Prejudice against MOUD even exists among specialist SUD
treatment providers. One 2020 national survey of residential OUD
treatment programs found that less than a third (29%) offered
maintenance treatment with buprenorphine-naloxone; many programs
actively discouraged the use of medication, which are the standard of
care, revealing that there is a vast knowledge gap about MOUD among
treatment providers.\84\
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\79\ Pew Charitable Trusts (2019). Why Aren't More People With
Opioid Use Disorder Getting Buprenorphine? Available at: <a href="https://www.pewtrusts.org/en/research-and-analysis/articles/2019/07/31/why-arent-more-people-with-opioid-use-disorder-getting-buprenorphine">https://www.pewtrusts.org/en/research-and-analysis/articles/2019/07/31/why-arent-more-people-with-opioid-use-disorder-getting-buprenorphine</a>.
\80\ Scorsone, K.L., Haozous, E.A., Hayes, L., & Cox, K.J.
(2020). Overcoming Barriers: Individual Experiences Obtaining
Medication-Assisted Treatment for Opioid Use Disorder. Qualitative
health research, 30(13), 2103-2117. <a href="https://doi.org/10.1177/1049732320938689">https://doi.org/10.1177/1049732320938689</a>.
\81\ McGinty, E.E., Stone, E.M., Kennedy-Hendricks, A.,
Bachhuber, M.A., & Barry, C.L. (2020). Medication for Opioid Use
Disorder: A National Survey of Primary Care Physicians. Annals of
internal medicine, 173(2), 160-162. <a href="https://doi.org/10.7326/M19-3975">https://doi.org/10.7326/M19-3975</a>.
\82\ Beetham, T., Saloner, B., Gaye, M., Wakeman, S.E., Frank,
R.G., & Barnett, M.L. (2020). Therapies Offered at Residential
Addiction Treatment Programs in the United States. JAMA, 324(8),
804-806. <a href="https://doi.org/10.1001/jama.2020.8969">https://doi.org/10.1001/jama.2020.8969</a>.
\83\ Hadland, S.E., Park, T.W., & Bagley, S.M. (2018). Stigma
associated with medication treatment for young adults with opioid
use disorder: a case series. Addiction science & clinical practice,
13(1), 15. <a href="https://doi.org/10.1186/s13722-018-0116-2">https://doi.org/10.1186/s13722-018-0116-2</a>.
\84\ Beetham, T., Saloner, B., Gaye, M., Wakeman, S.E., Frank,
R.G., & Barnett, M.L. (2020). Therapies Offered at Residential
Addiction Treatment Programs in the United States. JAMA, 324(8),
804-806. <a href="https://doi.org/10.1001/jama.2020.8969">https://doi.org/10.1001/jama.2020.8969</a>.
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Proposed changes to part 8 seek to reduce discriminatory attitudes
and beliefs, and to incorporate evidence-based principles on
practitioner autonomy, patient-centered decision making and
individualized care plans. This is in line with the chronic disease
model of care,\85\ and represents a departure from the prescriptive
model of care currently in place. In this way, The Department seeks to
support practitioners in providing evidence-based and compassionate
care to patients while also engaging them in recovery. This is an
essential means of reducing stigma among practitioners and community
members, while also positively addressing a patient's internalized
stigma.\86\
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\85\ Grover, A., & Joshi, A. (2014). An overview of chronic
disease models: a systematic literature review. Global journal of
health science, 7(2), 210-227. <a href="https://doi.org/10.5539/gjhs.v7n2p210">https://doi.org/10.5539/gjhs.v7n2p210</a>.
\86\ Idemudia, E.S., Olasupo, M.O., & Modibo, M.W. (2018).
Stigma and chronic illness: A comparative study of people living
with HIV and/or AIDS and people living with hypertension in Limpopo
Province, South Africa. Curationis, 41(1), e1-e5. <a href="https://doi.org/10.4102/curationis.v41i1.1879">https://doi.org/10.4102/curationis.v41i1.1879</a>.
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Request for Comments

The Department requests public comment on all aspects of the
proposed amendments to the regulations at 42 CFR part 8, Medications
for the Treatment of Opioid Use Disorder. The Department welcomes
public comment on any benefits or drawbacks of the proposed amendments
set forth above in this proposed rule. Of particular interest are
comments pertaining to: interim treatment; split dosing; telehealth;
and take home doses of methadone.

Public Participation

The Department seeks comment on all issues raised by the proposed
regulation, including any potential unintended adverse consequences.
Because of the large number of public comments normally received on
Federal Register documents, the Department is not able to acknowledge
or respond to them individually. In developing the final rule, the
Department will consider all comments that are received by the date and
time specified in the DATES section of the Preamble.
Because mailed comments may be subject to delays due to security
procedures, please allow sufficient time for mailed comments to be
received by the deadline in the event of delivery delays. Any
attachments submitted with electronic comments on <a href="http://www.regulations.gov">www.regulations.gov</a>
should be in Microsoft Word or Portable Document Format (PDF). Please
note that comments submitted by fax or email and those submitted after
the comment period deadline will not be accepted.

Regulatory Impact Analysis

The Department has examined the impact of the proposed rule as
required by Executive Order 12866 on Regulatory Planning and Review, 58
FR 51735 (October 4, 1993); Executive Order 13563 on Improving
Regulation and Regulatory Review, 76 FR 3821 (January 21, 2011);
Executive Order 13132 on Federalism, 64 FR 43255 (August 10, 1999);
Executive Order 13175 on Consultation and Coordination with Indian
Tribal Governments, 65 FR 67249 (November 9, 2000); Executive Order
13985 Advancing Racial Equity and Support for Underserved Communities
Through the Federal Government, 86 FR 7009 (January 25, 2021); the
Congressional Review Act, Public Law 104-121, sec. 251, 110 Stat. 847
(March 29, 1996); the Unfunded Mandates Reform Act of 1995, Public Law
104-4, 109 Stat. 48 (March 22, 1995); the Regulatory Flexibility Act,
Public Law 96-354, 94 Stat. 1164 (September 19, 1980); Executive Order
13272 on Proper Consideration of Small Entities in Agency Rulemaking,
67 FR 53461 (August 16, 2002); the Assessment of Federal Regulations
and Policies on Families, Public Law 105-277, sec. 654, 112 Stat. 2681
(October 21, 1998); and the Paperwork Reduction Act of 1995, Public Law
104-13, 109 Stat. 163 (May 22, 1995).

Statement of Need

This proposed rule is being issued to update part 8 in response to
increasing opioid overdose deaths, exacerbated by the COVID-19
pandemic.\87\ Across the United States in 2020, 9.5 million people aged
12 or older misused heroin or prescription pain relievers.\88\ The
percentage was highest among young adults aged 18 to 25 (4.1 percent or
1.4 million people), followed by adults aged 26 or older (3.4 percent
or 7.5 million people). It was lowest among adolescents aged 12 to 17
(1.6 percent or 396,000 people).\88\ These numbers likely underestimate
the true prevalence of opioid misuse and OUD, since the use of
illicitly manufactured fentanyl has not to date been considered in the
National Survey on Drug Use and Health (NSDUH) survey, and populations
likely to have high prevalence of opioid misuse and use disorder, such
as individuals in the criminal justice system, other institutionalized
settings, and individuals experiencing homelessness not living in
shelters are not included in the NSDUH.
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\87\ Cartus AR, Li Y, Macmadu A, Goedel WC, Allen B,
Cerd[aacute] M, Marshall BDL. Forecasted and Observed Drug Overdose
Deaths in the US During the COVID-19 Pandemic in 2020. JAMA Netw
Open. 2022 Mar 1;5(3):e223418. doi: 10.1001/
jamanetworkopen.2022.3418. PMID: 35311967; PMCID: PMC8938716.
\88\ Substance Abuse and Mental Health Services Administration.
(2021). Key substance use and mental health indicators in the United
States: Results from the 2020 National Survey on Drug Use and Health
(HHS Publication No. PEP21-07-01-003, NSDUH Series H-56). Rockville,
MD: Center for Behavioral Health Statistics and Quality, Substance
Abuse and Mental Health Services Administration. Retrieved from
<a href="https://www.samhsa.gov/data/">https://www.samhsa.gov/data/</a>.
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Further to this, there are important equity considerations
evidenced by the data. A recent analysis by the Centers for Disease
Control and Prevention (CDC) demonstrates high levels of overdose among
Black, American Indian and Alaska Native communities over the course of
the pandemic.\89\ This study showed that overdose death rates rose 44
percent in 2020 for Black people and 39 percent for American Indian and
Alaska Native people, compared with 22 percent for white people.\89\
Black youth ages 15 to 24 saw an 86 percent increase in overdose
deaths, the largest spike of any age or race group, while Black men 65
and older were nearly seven times as likely than white men to die from
an overdose.\89\ It was also found that Black people were less than
half as likely as white people to have received substance use
treatment.
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\89\ Kariisa M, Davis NL, Kumar S, et al. Vital Signs: Drug
Overdose Deaths, by Selected Sociodemographic and Social
Determinants of Health Characteristics--25 States and the District
of Columbia, 2019-2020. MMWR Morb Mortal Wkly Rep 2022;71:940-947.
DOI: <a href="https://dx.doi.org/10.15585/mmwr.mm7129e2">https://dx.doi.org/10.15585/mmwr.mm7129e2</a>.
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Research demonstrates that MOUD can reduce mortality from overdose
by up to 59% (based on results of multivariable Cox proportional
hazards models adjusted for age; sex; baseline

[[Page 77344]]

anxiety diagnosis; depression diagnosis; receipt of methadone,
buprenorphine, opioid, and benzodiazepine prescriptions in the 12
months before index nonfatal opioid overdose; and time-varying receipt
of opioid prescriptions, benzodiazepine prescriptions, withdrawal
management episode, and short- and long-term residential treatments
\90\), yet few people who may benefit from these medications have
immediate and sustained access to them.\91\
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\90\ Larochelle MR, Bernson D, Land T, Stopka TJ, Wang N, Xuan
Z, Bagley SM, Liebschutz JM, Walley AY (2018). Medication for Opioid
Use Disorder After Nonfatal Opioid Overdose and Association With
Mortality: A Cohort Study. Ann Intern Med. Aug 7;169(3):137-145.
doi: 10.7326/M17-3107.
\91\ Winograd RP, Presnall N, Stringfellow E, Wood C, Horn P,
Duello A, Green L, Rudder T. (2019). The case for a medication first
approach to the treatment of opioid use disorder. Am J Drug Alcohol
Abuse. 2019;45(4):333-340. doi: 10.1080/00952990.2019.1605372. Epub
2019 May 14. PMID: 31084515.
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The pattern of enrollment in programs providing methadone was
established in the latter part of the 20th century.\92\ Research
reveals that the rate of methadone treatment at that time was highest
in low income urban areas.\93\ These patterns have remained relatively
unchanged since the expansion of access to buprenorphine in 2002.
Research demonstrates that there are extensive `treatment deserts'
where there is little to no physical access to OTPs, especially in
rural areas.\94\ SAMHSA believes that proposed changes to part 8 will,
as described above, facilitate:
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\92\ D'Aunno T, Pollack HA. (2002). Changes in methadone
treatment practices: results from a national panel study, 1988-2000.
JAMA. 2002;288(7):850-856. doi:10.1001/jama.288.7.850.
\93\ Strain EC, Stitzer ML, Liebson IA, Bigelow GE. (1994).
Comparison of buprenorphine and methadone in the treatment of opioid
dependence. Am J Psychiatry. 1994 Jul;151(7):1025-30. doi: 10.1176/
ajp.151.7.1025. PMID: 8010359.
\94\ Mitchell P, Samsel S, Curtin KM, Price A, Turner D, Tramp
R, Hudnall M, Parton J, Lewis D. (2022). Geographic disparities in
access to Medication for Opioid Use Disorder across US census tracts
based on treatment utilization behavior. Soc Sci Med. 2022
Jun;302:114992. doi: 10.1016/j.socscimed.2022.114992. Epub 2022 Apr
28. PMID: 35512612.
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<bullet> Enhanced access to medications for opioid use disorder,
such as through take home doses of methadone and extending interim
treatment to 180 days;
<bullet> Changes to ensure updated language and terminology;
<bullet> Clarification of standards applying to accreditation
bodies;
<bullet> Revising Federal Opioid Use Disorder Treatment Standards;
and
<bullet> Removing reporting requirements for practitioners approved
to treat up to 275 patients.
SAMHSA notes below that these changes are associated with limited
burden as the proposed rule does not substantially alter reporting or
accreditation activities. The changes proposed will support SAMHSA in
its role of overseeing accrediting bodies and OTPs, modernizing
language and expectations in response to current challenges and
anticipated future trends. SAMHSA invites comments on the assumptions
of costs and benefits identified below, including citations to any
publicly available studies or reports that could elucidate and improve
this analysis.

A. Executive Orders 12866 and 13563 and Related Executive Orders on
Regulatory Review

Executive Order 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). Executive Order 13563 is
supplemental to, and reaffirms the principles, structures, and
definitions governing regulatory review as established in, Executive
Order 12866.
This proposed rule is partially regulatory and partially
deregulatory. The Department estimates that because much of what is
being proposed does not substantially alter current practice as
implemented over the past 2 years under the COVID PHE, the proposed
rule will not result in significantly altered costs. Further to this,
the proposed rule creates efficiencies in service delivery and in
administration. These include strengthening the patient-practitioner
relationship in a manner that promotes efficient, evidence-based and
patient-centered care, updating accreditation procedures and providing
a stable regulatory environment. Additionally, the proposed rule makes
permanent some OTP treatment flexibilities implemented within the past
two years.

B. Executive Order 13985 Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government

A recent analysis by the Centers for Disease Control and Prevention
(CDC) demonstrates high levels of overdose among Black, American Indian
and Alaska Native communities over the course of the pandemic.\95\
While these trends existed long before the COVID-19 PHE, this study
highlights that overdose death rates rose 44 percent in 2020 for Black
people and 39 percent for American Indian and Alaska Native people,
compared with 22 percent for white people.\95\ Black youth ages 15 to
24 saw an 86 percent increase in overdose deaths, the largest spike of
any age or race group, while Black men 65 and older were nearly seven
times as likely than white men to die from an overdose.\95\ It was also
found that Black people were less than half as likely as white people
to have received substance use treatment.
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\95\ Kariisa M., Davis N.L., Kumar S., et al. Vital Signs: Drug
Overdose Deaths, by Selected Sociodemographic and Social
Determinants of Health Characteristics--25 States and the District
of Columbia, 2019-2020. MMWR Morb Mortal Wkly Rep 2022;71:940-947.
DOI: <a href="https://dx.doi.org/10.15585/mmwr.mm7129e2">https://dx.doi.org/10.15585/mmwr.mm7129e2</a>.
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This disparity amplifies the importance of promoting person-
centered care that is culturally appropriate and responsive to patient
need, while also fostering a treatment environment that promotes and
sustains patient engagement. The proposed changes facilitate the
practitioner-patient relationship in a manner that espouses these
principles, while also expanding the reach of OTPs (through activities
such as mobile medication units) to physically engage communities that
are in need of intervention. Further to this, the proposed changes
promote examination of a patient's cultural needs as they engage in
treatment services. This is consistent with evidence-based and
culturally responsive paradigms of care.
The proposed changes also facilitate patient engagement through
removing, at the practitioner's discretion, the requirement to attend
an OTP each day. Indeed, the ability to provide unsupervised doses of
methadone early in treatment allows those with unstable access to
transportation, for example, to focus on recovery activities in their
own community. Evidence from the past two years demonstrates safety, as
well as high patient and practitioner satisfaction with take-home doses
of methadone. This is principally because unsupervised doses of
methadone allow individuals the opportunity to engage in employment or
other activities that are supportive of recovery and longer term
community involvement.
1. Cost-Benefit Analysis
a. Overview
The U.S. estimated economic cost of opioid use disorder ($471
billion) and fatal opioid overdose ($550 billion), prior to the
pandemic, totaled $1,021 billion.\96\ Among the 39 jurisdictions

[[Page 77345]]

reviewed in this analysis, combined costs of opioid use disorder and
fatal opioid overdose varied from $985 million in Wyoming to $72.6
billion in Ohio. Per capita combined costs varied from $1,204 in Hawaii
to $7,247 in West Virginia. States with high per capita combined costs
were located mainly in the Ohio Valley and New England. Across many
studies, reduced quality of life is the largest component of the cost
of opioid use disorder.\97\
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\96\ Luo, F., Li, M., & Florence, C. (2021). State-Level
Economic Costs of Opioid Use Disorder and Fatal Opioid Overdose--
United States, 2017. MMWR. Morbidity and mortality weekly report,
70(15), 541-546. <a href="https://doi.org/10.15585/mmwr.mm7015a1">https://doi.org/10.15585/mmwr.mm7015a1</a>.
\97\ Mitchell, S.G., Gryczynski, J., Schwartz, R.P., Myers,
C.P., O'Grady, K.E., Olsen, Y.K., & Jaffe, J.H. (2015). Changes in
Quality of Life following Buprenorphine Treatment: Relationship with
Treatment Retention and Illicit Opioid Use. Journal of psychoactive
drugs, 47(2), 149-157. <a href="https://doi.org/10.1080/02791072.2015.1014948">https://doi.org/10.1080/02791072.2015.1014948</a>.
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A recent study showed that in the absence of treatment, 42,717
overdoses (4,132 fatal, 38,585 nonfatal) and 12,660 deaths were
estimated to occur in a cohort of 100,000 patients over 5 years.\98\ An
estimated reduction in overdoses was associated with methadone
treatment (10.7%), buprenorphine or naltrexone treatment (22.0%), and
medication treatment combined with psychotherapeutic interventions
(range, 21.0%-31.4%).\98\ Estimated decreased deaths were associated
with treatment with methadone (6%), buprenorphine or naltrexone
(13.9%), and the combination of medications and psychotherapy (16.9%).
When criminal justice costs were included, all forms of MOUD (with
buprenorphine, methadone, and naltrexone) were associated with cost
savings compared with no treatment, yielding savings of $25,000 to
$105,000 in lifetime costs per person.
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\98\ Fairley M., Humphreys K., Joyce V.R., et al. (2021). Cost-
effectiveness of Treatments for Opioid Use Disorder. JAMA
Psychiatry. 2021;78(7):767-777. doi:10.1001/
jamapsychiatry.2021.0247.
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McAdam-Marx et al. reported in 2010 that Medicaid beneficiaries
with opioid use disorder, physical dependence on opioids, or poisoning
had nearly triple the total medical costs adjusted for baseline sample
characteristics compared to beneficiaries matched by age, gender, and
state with no opioid misuse diagnosis ($23,556 vs. $8436; P <
0.001).\99\ The opioid dependence/abuse group (using an older version
of the Diagnostic and Statistical Manual of Mental Disorders) also had
higher prevalence of comorbidities, such as psychiatric disorders,
pain-related diagnoses, and other substance use conditions. While this
study considered overall cost, it did not address medication costs in
particular, or any impact treatment may have had on overall cost.
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\99\ McAdam-Marx C., Roland C.L., Cleveland J., Oderda G.M.
(2010). Costs of opioid abuse and misuse determined from a Medicaid
database. J Pain Palliat Care Pharmacother. 2010 Mar;24(1):5-18.
doi: 10.3109/15360280903544877. PMID: 20345194.
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OTPs provide comprehensive interventions including medications,
counseling and services designed to offer a whole-person approach to
care and ameliorate social determinants of health that contribute to
substance misuse. Numerous studies have demonstrated that treatment
with pharmacotherapy and counseling services can reduce overall
healthcare costs for patients with OUD.100 101 102 For
example, a 2019 analysis demonstrated that a comprehensive approach to
OUD treatment is associated with improved health and economic
outcomes.\103\ This study assessed patients with OUD treated at a
comprehensive primary care center (CCP) and other Maryland facilities
in a large state Medicaid program, and demonstrated cost savings with a
comprehensive approach to care. Compared to the non-CCP patient group
(n = 867), the CCP group (n = 131) had a higher 6-month buprenorphine
treatment retention rate (P < 0.001), fewer hospital stays in the 12-
month follow-up period (P = 0.005), and lower total cost (US$10,942 vs.
$13,097, P < 0.001) and hospital stay cost (US$1448 vs. $4265, P =
0.001).\103\ Other measures, including emergency department utilization
and cost, substance use-related cost, and non-buprenorphine pharmacy
cost, were not statistically different between the 2 groups. Results
suggested that patients, as well as the health care system, can benefit
from a comprehensive model of care for OUD with better treatment
retention, fewer hospital stays, and lower costs.
---------------------------------------------------------------------------

\100\ Murphy S.M., Polsky D. (2016). Economic Evaluations of
Opioid Use Disorder Interventions. Pharmacoeconomics. 2016
Sep;34(9):863-87. doi: 10.1007/s40273-016-0400-5. PMID: 27002518;
PMCID: PMC5572804.
\101\ Baser O., Chalk M., Fiellin D.A., Gastfriend D.R. (2011).
Cost and utilization outcomes of opioid-dependence treatments. Am J.
Manag Care. 2011 Jun;17 Suppl 8:S235-48. PMID: 21761950.
\102\ Lynch F.L., McCarty D., Mertens J., Perrin N.A., Green
C.A., Parthasarathy S., Dickerson J.F., Anderson B.M., Pating D.
(2014). Costs of care for persons with opioid dependence in
commercial integrated health systems. Addict Sci Clin Pract. 2014
Aug 14;9(1):16. doi: 10.1186/1940-0640-9-16. PMID: 25123823; PMCID:
PMC4142137.
\103\ Hsu Y.J., Marsteller J.A., Kachur S.G., Fingerhood M.I.
(2019). Integration of Buprenorphine Treatment with Primary Care:
Comparative Effectiveness on Retention, Utilization, and Cost.
Idemudia, E.S., Olasupo, M.O., & Modibo, M.W. (2018). Stigma and
chronic illness: A comparative study of people living with HIV and/
or AIDS and people living with hypertension in Limpopo Province,
South Africa. Curationis, 41(1), e1-e5. <a href="https://doi.org/10.4102/curationis.v41i1.1879">https://doi.org/10.4102/curationis.v41i1.1879</a>.
---------------------------------------------------------------------------

These findings are consistent with a 2016 cross sectional study
that evaluated medical claims for Vermont Medicaid beneficiaries with
opioid dependence or addiction between 2008 and 2013. In their
analysis, Mohlman and colleagues determined that medication combined
with psychosocial counseling is associated with reduced general health
care expenditures and utilization, such as inpatient hospital
admissions and outpatient emergency department visits, for Medicaid
beneficiaries with opioid misuse.\104\ Two prior studies assessed data
from commercial health insurance claims on the overall health care
costs and utilization rates for those using MOUD compared to those
treated without MOUD.101 105 The first study found that over
a five-year period, members on MOUD had 50% lower total annual health
plan costs than those who had two or more visits to an addiction
treatment setting and no treatment, and 62% lower than those with zero
or one visit for addiction treatment and no intervention.\105\ The
other study found that after a six-month period, those on MOUD had
significantly lower overall annual health plan costs compared to those
with no medication ($10,192 vs. $14,353; p-value < 0.0001).\101\ The
difference was driven largely by lower inpatient services and non-
opioid-related outpatient services for the group receiving medication.
---------------------------------------------------------------------------

\104\ Mohlman M.K., Tanzman B., Finison K., Pinette M., Jones C.
Impact of Medication-Assisted Treatment for Opioid Addiction on
Medicaid Expenditures and Health Services Utilization Rates in
Vermont. J Subst Abuse Treat. 2016 Aug; 67:9-14. doi: 10.1016/
j.jsat.2016.05.002. Epub 2016 May 9. PMID: 27296656.
\105\ McCarty D., Perrin N.A., Green C.A., Polen M.R., Leo M.C.,
Lynch F. (2010). Methadone maintenance and the cost and utilization
of health care among individuals dependent on opioids in a
commercial health plan. Drug Alcohol Depend. 2010 Oct 1;111(3):235-
40. doi: 10.1016/j.drugalcdep.2010.04.018. PMID: 20627427; PMCID:
PMC2950212.
---------------------------------------------------------------------------

The regulatory impact analysis (RIA) outlined below, relies on data
provided to SAMHSA by OTP accreditation bodies for the year 2020-2021.
Pursuant to 42 CFR part 8, accreditation bodies and OTPs are required
to submit information to SAMHSA's Center for Substance Abuse Treatment
(CSAT). The annualized burden of information collection for OTPs and
accreditation bodies under the rule is set forth in the tables that
follow.
This proposed rule does not substantially alter reporting burden or
accreditation activities. The total number of burden hours reported in

[[Page 77346]]

2020-2021 for accreditation body respondents was approximately 394.70
hours. The total number of burden hours for OTP respondents during the
same period was 1,868.95 hours. The annual burden associated with this
rule and the associated forms was estimated to be 2,263.65 hours.
This analysis quantifies a few limited categories of paperwork-
related costs, but there are more substantive actions (with associated
costs and benefits) that would be necessary in the chain of cause and
effect between the rule's most direct effects and the health and
mortality consequences that are implied, above, as being potentially
large if this proposal is finalized. For instance, relative to the
appropriate analytic baseline (the future in the absence of the rule),
the proposed rule would facilitate the expansion of mobile methadone
units via their inclusion in operations, and such expansion would
entail both new use of resources (costs \106\) and then, contingent
upon such costs being incurred, the types of benefits described above.
As a further example, the accrual of health and overdose-mortality-
avoidance benefits due to removal of the one-year requirement for
opioid addiction before patient admission to an OTP would generally be
contingent upon increasing resource use associated with such admission.
---------------------------------------------------------------------------

\106\ It would be incorrect to interpret this analytic
discussion as implying that the proposed rule changes authorization
procedures for mobile methadone units.
---------------------------------------------------------------------------

b. Estimated Costs of Reporting Burdens for OTPs and Accreditation
Bodies
In developing its estimates of the potential costs of the proposed
regulation, the Department relied substantially on recent estimates of
burden and cost pertaining to requirements set forth in 42 CFR part 8.
Hourly labor costs involved in reporting requirements vary greatly
between programs. Based on wage estimates obtained from the U.S.
Department of Labor, Bureau of Labor Statistics, and Occupational
Employment Statistics website, it is estimated that employees involved
in complying with reporting requirements range from minimum wage
($7.25) clerical workers, to counselors averaging $22.14 an hour,
managers, licensed practical nurses and registered nurses averaging
$35.36 per hour, administrators averaging $52.58 per hour, and
physicians averaging $96.26 per hour. The estimated average hourly wage
for program personnel involved in reporting requirements, calculated as
a simple mean, is $42.71. Multiplying the estimated average hourly wage
by 2.0 to account for fringe benefits and overhead costs, an estimated
hourly labor cost of $85.42 is obtained. The cost to accreditation
bodies for applying for initial and ongoing approval with Form SMA-163,
as well as for complying with the reporting requirements under 42 CFR
8.4 and 8.6 may be estimated at $33,672.56, using the $85.42 hourly
cost figure. The estimated total annualized cost to the treatment
program respondents for preparing the Form SMA-162 and for complying
with other reporting requirements pursuant to 42 CFR 8.11, 8.24, 8.25,
8.26, and 8.28, using $85.42 as the hourly cost figure, is $16,140.11.

----------------------------------------------------------------------------------------------------------------
Preparation
Items time (hours) Cost/hour Total cost
----------------------------------------------------------------------------------------------------------------
Form SMA-163, compliance with the reporting requirements under 42 CFR 394.2 $85.42 $33,672.56
8.4 and 8.6..........................................................
Form SMA-162, compliance with other reporting requirements under 21 188.95 85.42 16,140.11
CFR 8.11, 8.24, 8.25, 8.26, and 8.28.................................
Form SMA-168, Exception Request and Record of Justification Under 42 2,135 85.42 182,371.70
CFR 8.11(h)..........................................................
-----------------------------------------
Subtotal.......................................................... .............. ........... 232,184.37
----------------------------------------------------------------------------------------------------------------

c. Cost Pertaining to Recordkeeping
The recordkeeping requirements set forth in 42 CFR 8.4 and 8.12
include maintenance of the following: a patient's medical examination
when admitted to treatment; a patient's history; a care plan; any
prenatal support provided to the patient; justification of unusually
large initial doses; changes in a patient's dosage schedule; the
rationale for decreasing a patient's clinic attendance; services
provided; and documentation of physiologic tolerance.
SAMHSA believes that the recordkeeping requirements are customary
and usual practices within the medical and behavioral health treatment
communities. Accreditation bodies also maintain accreditation records
for 5 or more years as a customary and usual practice. SAMHSA has
neither calculated a response burden nor a cost burden for these
activities.
d. Costs Pertaining to Disclosure
The proposed rule includes requirements that OTPs and accreditation
organizations disclose information. For example, Sec. 8.12(e)(1)
requires that a practitioner explain the facts concerning the use of
MOUD to each patient. This type of disclosure is consistent with common
medical practice and is not considered an additional burden. Further,
the rule requires, under Sec. 8.4(i)(1), that accreditation
organizations shall make public their fee structure. This type of
disclosure is standard business practice and is not considered a burden
in this analysis.
e. Estimate of Annualized Non-Hourly Cost Burden to Respondents
The proposed rule does not impose new capital or startup costs
beyond the normal office and laboratory equipment required for
achieving regulatory compliance. It is estimated that there are some
costs associated with preparation for the accreditation site visit
itself; assuming that OTP staff spend approximately 180 hours preparing
for the site visit at an average cost of $85.42 per hour and an average
of 1.33 site visits per facility, the total cost would be $20,450 or an
annualized cost of $15,376 per facility. For the current approximately
1,920 affected OTPs these total annual costs are estimated to be
$29,521,920. The percentage of this total cost that is associated with
recordkeeping and reporting-only is difficult to estimate, but it is
considered to be a small fraction of the total associated with
accreditation.
i. Estimate of Annualized Cost to the Government
The total annualized cost to SAMHSA for administering 42 CFR part 8
is estimated at $450,000. This estimate includes the cost of an outside
contractor to develop and maintain an extensive on-line system for
SAMHSA,

[[Page 77347]]

opioid treatment programs, State opioid treatment authorities,
accreditation organizations, and others to have use a protected website
for day-to-day regulatory activities. This estimate does not include
funds that SAMHSA/CSAT allocates to its ``look back'' program that
monitors the adequacy of accreditation surveys. Of this amount, the
total annualized cost to SAMHSA for Paperwork Reduction Act activities
as a result of this regulation is estimated as $221,434, as shown in
the following table.

Annualized Cost to SAMHSA/CSATT
----------------------------------------------------------------------------------------------------------------
Total cost
Item (purpose) Responses Hours per Total @$85.42 per
response hours hour
----------------------------------------------------------------------------------------------------------------
SMA-162 (New Programs)..................................... 42 1.5 63 $5,381
SMA-162 (Renewal).......................................... 386 .75 289.5 24,729
SMA-162 (Relocation)....................................... 35 .25 8.75 747
Notification of Provisional Certification.................. 40 .50 20 1,708
Notification of Extension of Provisional Certification..... 15 .50 7.5 641
Notification of Sponsor or Medical Director Change......... 60 0.33 19.8 1,691
Documentation to SAMHSA for Interim Treatment.............. 1 0.50 0.5 43
Requests to SAMHSA for Exemption from Sec. Sec. 8.11 and 24,000 0.07 1680 143,506
8.12 (including SMA-168)..................................
Notification to SAMHSA Before Establishing Medication Units 20 1.00 20 1,708
Review of Submissions under Part C......................... 2 2.00 4 342
Accreditation Body Initial Application (SMA-163)........... 3 40 120 10,250
Accreditation Body Renewal (SMA-163)....................... 3 40 120 10,250
Relinquishment Notification................................ 1 .50 0.5 43
Notification for Serious Non-Compliant Programs............ 2 .50 1 85
General Documents to SAMHSA Upon Request................... 10 1.00 10 854
Accreditation Survey to SAMHSA Upon Request................ 383 .50 191.5 16,358
Less Than Full Accreditation Report to SAMHSA.............. 10 1.00 10 854
Summaries of Inspections................................... 12 1.00 12 1,025
Notification of Complaints to SAMHSA....................... 10 1.00 10 854
Submission of 90-Day Corrective Plan to SAMHSA............. 1 4.25 4.25 363
----------------------------------------------------
Subtotal............................................... 25,036 97.15 2592.3 221,434
----------------------------------------------------------------------------------------------------------------

2. Consideration of Regulatory Alternatives
The Department has initiated rulemaking to make flexibilities
issued during the COVID-19 PHE permanent, while also updating
accreditation and treatment standards to reflect evidence-based
practices and current medical terminology and approaches to OUD
treatment given the current overdose crisis. The alternative would be
to allow the current flexibilities to lapse with the end of the COVID-
19 PHE, or to renew them periodically as may be needed during future
emergencies or changed circumstances.
3. Request for Comments on Costs and Benefits
The Department requests public comment on all the estimates,
assumptions, and analyses within the cost-benefits analysis. As part of
this request, feedback is welcome on the extent to which cited papers
follow sound scientific practices, such as: clearly stating null
hypotheses and presenting estimating equations; ensuring that
appendices or other supplementary materials are available online, if
claimed to be so in the main body of a paper; using compelling
identification strategies if making causal claims (for example,
establishing parallel trends pre-intervention if using a difference-in-
differences method \107\); and avoiding the types of errors that Kim et
al. (2020 \108\) and Sanders et al. (2016 \109\) indicate are common in
published cost-effectiveness analyses. The Department also requests
comments on any relevant information or data that would inform a
quantitative analysis of proposed reforms that the Department
qualitatively addresses in this RIA. The Department also requests
comments on whether there may be other indirect costs and benefits
resulting from the proposed changes in the proposed rule and welcomes
additional information that may help quantify those costs and benefits.
---------------------------------------------------------------------------

\107\ Wing C, Simon K, Bello-Gomez RA (2018). Designing
difference in difference studies: best practices for public health
policy research. Annual Review of Public Health 39: 453-469.
\108\ Kim DD, Silver MC, Kunst N, et al. (2020). Perspective and
costing in cost-effectiveness analysis, 1974-2018. PharmacoEconomics
38: 1135-1145.
\109\ Sanders GD, Neumann PJ, Basu A, et al. (2016).
Recommendations for conduct, methodological practices, and reporting
of cost-effectiveness analyses: second panel on cost-effectiveness
in health and medicine, JAMA, 1093-1103.
---------------------------------------------------------------------------

B. Regulatory Flexibility Act

The Department has examined the economic implications of this
proposed rule as required by the Regulatory Flexibility Act (5 U.S.C.
601-612). If a rule has a significant economic impact on a substantial
number of small entities, the Regulatory Flexibility Act (RFA) requires
agencies to analyze regulatory options that would lessen the economic
effect of the rule on small entities. For purposes of the RFA, small
entities include small businesses, nonprofit organizations, and small
governmental jurisdictions. The Act defines ``small entities'' as (1) a
proprietary firm meeting the size standards of the Small Business
Administration (SBA), (2) a nonprofit organization that is not dominant
in its field, and (3) a small government jurisdiction of less than
50,000 population. Because 90 percent or more of all health care
providers meet the SBA size standard for a small business or are
nonprofit organizations, the Department generally treats all health
care providers as small entities for purposes of performing a
regulatory flexibility analysis. The SBA size standard for health care
providers ranges between a maximum of $8 million and $41.5 million in
annual receipts, depending upon the type of entity.
For the reasons stated above, it is not expected that the cost of
compliance would be significant for OTPs or accreditation bodies.
Therefore, this

[[Page 77348]]

proposed rule would not result in a significant negative impact.

C. Unfunded Mandates Reform Act

Section 202(a) of The Unfunded Mandates Reform Act of 1995 (UMRA)
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending that may result in
expenditures in any one year of $100 million in 1995 dollars, updated
annually for inflation. As of 2022, this threshold is $165 million. The
Department does not anticipate that this proposed rule would result in
the expenditure by state, local, and tribal governments, taken
together, or by the private sector, of $165 million or more in any one
year.

D. Executive Order 13132--Federalism

Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on state
and local governments, preempts state law, or otherwise has federalism
implications. The Department does not believe that this rulemaking
would have any significant federalism implications, impose significant
costs on state or local governments or preempt state law.

E. Assessment of Federal Regulation and Policies on Families

Section 654 of the Treasury and General Government Appropriations
Act of 1999 \110\ requires Federal departments and agencies to
determine whether a proposed policy or regulation could affect family
well-being. If the determination is affirmative, then the Department or
agency must prepare an impact assessment to address criteria specified
in the law. The Department believes that the proposed regulations would
positively impact the ability of patients and families to access
treatment for OUD. The Department does not anticipate negative impacts
on family well-being as a result of this rulemaking as described.
---------------------------------------------------------------------------

\110\ Public Law 105-277, 112 Stat. 2681 (October 21, 1998).
---------------------------------------------------------------------------

F. Paperwork Reduction Act of 1995

Under the Paperwork Reduction Act of 1995 (PRA) (Pub. L. 104-13),
agencies are required to submit to the Office of Management and Budget
(OMB) for review and approval any reporting or recordkeeping
requirements inherent in a proposed or final rule, and are required to
publish such proposed requirements for public comment. The PRA requires
agencies to provide a 60-day notice in the Federal Register and solicit
public comment on a proposed collection of information before it is
submitted to OMB for review and approval. To fairly evaluate whether an
information collection should be approved by OMB, section 3506(c)(2)(A)
of the PRA requires that the Department solicit comment on the
following issues:
1. Whether the information collection is necessary and useful to
carry out the proper functions of the agency;
2. The accuracy of the agency's estimate of the information
collection burden;
3. The quality, utility, and clarity of the information to be
collected; and
4. Recommendations to minimize the information collection burden on
the affected public, including automated collection techniques.
The PRA requires consideration of the time, effort, and financial
resources necessary to meet the information collection requirements
referenced in this section. The Department explicitly seeks, and will
consider, public comment on its assumptions as they relate to the PRA
requirements summarized in this section.
As discussed below, the Department estimates a total OTP burden
associated with all information collections of 1,868.95 hours, and a
total number of burden hours for accreditation body respondents of
approximately 394.70 hours each year. The annual burden associated with
this rule and the associated forms is therefore estimated to be
2,263.65 hours.
1. Explanation of Estimated Annualized Burden Hours for 42 CFR Part 8
The Department presents, in separate tables below, burden estimates
for the annual reporting requirement for accreditation bodies and also
OTPs pursuant to the proposed rule.

Estimated Annual Reporting Requirement Burden for Accreditation Bodies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Total Hours/ Total
42 CFR citation Purpose respondents respondent Responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3(b)(1) through (11)....................... Initial approval (SMA-163).......... 1 1 1 6.0 6
8.3(c)....................................... Renewal of approval (SMA-163)....... 2 1 2 1.0 2
8.3(e)....................................... Relinquishment notification......... 1 1 1 0.5 0.5
8.3(f)(2).................................... Non-renewal notification to 1 90 90 0.1 9
accredited OTPs.
8.4(b)(1)(ii)................................ Notification to SAMHSA for seriously 2 2 4 1.0 4
noncompliant OTPs.
8.4(b)(1)(iii)............................... Notification to OTP for serious 2 10 20 1.0 20
noncompliance.
8.4(d)(1).................................... General documents and information to 6 5 30 0.5 15
SAMHSA upon request.
8.4(d)(2).................................... Accreditation survey to SAMHSA upon 6 75 450 0.02 9
request.
8.4(d)(3).................................... List of surveys, surveyors to SAMHSA 6 6 36 0.2 7.2
upon request.
8.4(d)(4).................................... Report of less than full 6 5 30 0.5 15
accreditation to SAMHSA.
8.4(d)(5).................................... Summaries of Inspections............ 6 50 300 0.5 150
8.4(e)....................................... Notifications of Complaints......... 12 6 72 0.5 36
8.6(a)(2) and (b)(3)......................... Revocation notification to 1 185 185 0.3 55.5
Accredited OTPs.
8.6(b)....................................... Submission of 90-day corrective plan 1 1 1 10 10.0
to SAMHSA.
8.6(b)(1).................................... Notification to accredited OTPs of 1 185 185 0.3 55.5
Probationary Status.
--------------------------------------------------------------------
Subtotal................................. .................................... 54 ............ 1,407 ........... 394.70
--------------------------------------------------------------------------------------------------------------------------------------------------------

Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Total Hours/
42 CFR citation Purpose respondents respondent responses response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.11(b)...................................... Renewal of approval (SMA-162)....... 386 1 386 0.15 57.9
8.11(b)...................................... Relocation of Program (SMA-162)..... 35 1 35 1.17 40.95

[[Page 77349]]

8.11(d)...................................... Application for provisional 42 1 42 1 42.00
certification.
8.11(f)...................................... Application for extension of 30 1 30 0.25 7.50
provisional certification.
8.11(g)(5)................................... Notification of sponsor or medical 60 1 60 0.1 6.00
director change (SMA-162).
8.11(h)(2)................................... Documentation to SAMHSA for interim 1 1 1 1 1.00
treatment.
8.11(i)...................................... Request to SAMHSA for Exemption from 1,200 20 24,000 0.07 1,680
Sec. Sec. 8.11 and 8.12
(including SMA-168).
8.11(j)(1)................................... Notification to SAMHSA Before 10 1 10 0.25 2.5
Establishing Medication Units (SMA-
162).
8.12(j)(2)................................... Notification to State Opioid 1 20 20 0.33 6.6
Treatment Authority for Interim
Treatment.
8.24......................................... Contents of Appellant Request for 2 1 2 0.25 .50
Review of Suspension.
8.25(a)...................................... Informal Review Request............. 2 1 2 1.00 2.00
8.26(a)...................................... Appellant's Review File and Written 2 1 2 5.00 10.00
Statement.
8.28(a)...................................... Appellant's Request for Expedited 2 1 2 1.00 2.00
Review.
--------------------------------------------------------------------
8.28(c)...................................... Appellant Review File and Written 2 1 2 5.00 10.00
Statement.
--------------------------------------------------------------------
Subtotal................................. .................................... 1,775 ............ 24,594 ........... 1,868.95
Total................................ .................................... 1,829 ............ 26,001 ........... 2,263.65
--------------------------------------------------------------------------------------------------------------------------------------------------------

The tables above reflect current estimates of burden, as the
proposed rule does not effectively add or alter new reporting
requirements. The estimates are derived from SAMHSA's data and are
reflective of work from over the preceding twelve months. Further to
this, the estimates of burden do not substantially differ from
previously submitted estimates provided to The Office of Management and
Budget.
The proposed rule does not alter reporting requirements as these
have been shown to be effective in the safe administration of OTPs. The
accreditation system provides effective oversight, while OTP reporting
requirements support accreditation activities and the provision of safe
treatment. Further to this, the proposed rule retains requirements that
OTP's and accreditation organizations disclose information related to
patient care and clinic policies and procedures for the treatment of
OUD with MOUD. For example, Sec. 8.12(e)(1) requires that a qualifying
health care practitioner explain the facts concerning the use of MOUD
to each patient. This type of disclosure is considered to be consistent
with common medical practice and is not considered an additional
burden. Further, the requirement under Sec. 8.4(i)(1) that each
accreditation organization shall make public its fee structure is
considered standard business practice and is not considered a burden in
this analysis.

List of Subjects in 42 CFR Part 8

Administrative practice and procedure, Health professions,
Methadone, Reporting and recordkeeping requirements, Substance misuse.

0
For the reasons stated in the preamble, the Department of Health and
Human Services proposes to revise 42 CFR part 8 to read as set forth
below:

PART 8--MEDICATIONS FOR THE TREATMENT OF OPIOID USE DISORDER

Subpart A--General Provisions
Sec.
8.1 Scope.
8.2 Definitions.
Subpart B--Accreditation of Opioid Treatment Programs
8.3 Application for approval as an accreditation body.
8.4 Accreditation body responsibilities.
8.5 Periodic evaluation of accreditation bodies.
8.6 Withdrawal of approval of accreditation bodies.
Subpart C--Certification and Treatment Standards for Opioid Treatment
Programs
8.11 Opioid Treatment Program certification.
8.12 Federal Opioid Use Disorder treatment standards.
8.13 Revocation of accreditation and accreditation body approval.
8.14 Suspension or revocation of certification.
8.15 Forms.
Subpart D--Procedures for Review of Suspension or Proposed Revocation
of OTP Certification, and of Adverse Action Regarding Withdrawal of
Approval of an Accreditation Body
8.21 Applicability.
8.22 Definitions.
8.23 Limitation on issues subject to review.
8.24 Specifying who represents the parties.
8.25 Informal review and the reviewing official's response.
8.26 Preparation of the review file and written arguments.
8.27 Opportunity for oral presentation.
8.28 Expedited procedures for review of immediate suspension.
8.29 Ex parte communications.
8.30 Transmission of written communications by reviewing official
and calculation of deadlines.
8.31 Authority and responsibilities of the reviewing official.
8.32 Administrative record.
8.33 Written decision.
8.34 Court review of final administrative action; exhaustion of
administrative remedies.
Subpart E [Reserved]
Subpart F--Authorization To Increase Patient Limit to 275 Patients
8.610 Practitioner eligibility requirements for a 3-year 275-patient
limit.
8.615 Definition of a qualified practice setting.
8.620 Applying for a 275-patient limit.
8.625 Processing a 275 Request for Patient Limit Increase.
8.630 Practitioner requirements to maintain a 275-patient limit.
8.640 Renewal process for a 3-year 275 Request for Patient Limit
Increase.
8.645 Practitioner responsibility when no renewal request for
patient limit increase is submitted, or whose renewal request is
denied.
8.650 Suspension or revocation of the Secretary's approval of a
practitioner's request for patient limit increase.
8.655 Temporary increase to treat up to 275 patients in emergency
situations.

Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2,
300x-23, 300x-27(a), 300y-11.

Subpart A--General Provisions

Sec. 8.1 Scope.

(a) This subpart and subparts B through D of this part establish
the procedures by which the Secretary of Health and Human Services (the
Secretary) will determine whether an

[[Page 77350]]

applicant seeking to become an Opioid Treatment Program (OTP) is
qualified under section 303(g) of the Controlled Substances Act (CSA)
(21 U.S.C. 823(g)(1)) to dispense Medications for Opioid Use Disorder
(MOUD) in the treatment of Opioid Use Disorder (OUD), and establishes
the Secretary's standards regarding the appropriate quantities of MOUD
that may be provided for unsupervised use by individuals undergoing
such treatment (21 U.S.C. 823(g)(1)). Under this subpart and subparts B
through D, an applicant seeking to become an OTP must first obtain from
the Secretary or, by delegation, from the Assistant Secretary for
Mental Health and Substance Use, a certification that the applicant is
qualified under the Secretary's standards and will comply with such
standards. Eligibility for certification will depend upon the applicant
obtaining accreditation from an accreditation body that has been
approved by the Secretary. This subpart and subparts B through D also
establish the procedures whereby an entity can apply to become an
approved accreditation body, and the requirements and general standards
for accreditation bodies to ensure that OTPs are consistently evaluated
for compliance with the Secretary's standards for treatment of OUD with
MOUD.
(b) The regulations in subpart F of this part establish the
procedures and requirements that practitioners who are authorized to
treat up to 100 patients with OUD pursuant to a waiver obtained under
section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)), must satisfy in
order to treat up to 275 patients with medications covered under
section 303(g)(2)(C) of the CSA.

Sec. 8.2 Definitions.

The following definitions apply to this part:
Accreditation body means an organization that has been approved by
the Secretary in this part to accredit OTPs dispensing MOUD.
Accreditation body application means the application filed with the
Secretary for purposes of obtaining approval as an accreditation body,
as described in Sec. 8.3(b).
Accreditation elements mean the elements or standards that are
developed and adopted by an accreditation body and approved by the
Secretary.
Accreditation survey means an onsite review and evaluation of an
OTP by an accreditation body for the purpose of determining compliance
with the Federal opioid treatment standards described in Sec. 8.12.
Accredited OTP means an OTP that is the subject of a current, valid
accreditation from an accreditation body approved by the Secretary
under Sec. 8.3(d).
Additional credentialing means board certification in Addiction
Medicine or Addiction Psychiatry by the American Board of Addiction
Medicine, the American Board of Medical Specialties, or the American
Osteopathic Association or certification by the American Board of
Addiction Medicine, the American Society of Addiction Medicine.
Approval term means the 3-year period in which a practitioner is
approved to treat up to 275 patients with OUD that commences when a
practitioner's Request for Patient Limit Increase is approved in
accordance with Sec. 8.625.
Behavioral health services means any intervention carried out in a
therapeutic context at an individual, family, or group level.
Interventions may include structured, professionally administered
clinical interventions (e.g., cognitive behavior therapy or insight-
oriented psychotherapy) delivered in-person, or remotely via
telemedicine, which has been shown to facilitate treatment outcomes, or
non-clinical interventions.
Care plan means an individualized treatment and/or recovery plan
that outlines attainable treatment goals that have been identified and
agreed upon between the patient and the OTP clinical team, and which
specifies the services to be provided, as well as the proposed
frequency and schedule for their provision.
Certification means the process by which the Secretary determines
that an OTP is qualified to provide OUD treatment under the Federal
Opioid Use Disorder treatment standards.
Certification application means the application filed by an OTP for
purposes of obtaining certification from the Secretary, as described in
Sec. 8.11(b).
Certified opioid treatment program means an OTP that is the subject
of a current, valid certification under Sec. 8.11.
Comprehensive treatment is treatment that includes the continued
use of MOUD provided in conjunction with an individualized range of
appropriate harm reduction, medical, behavioral health, and recovery
support services.
Conditional certification is a type of temporary certification
granted to an OTP that has requested renewal of its certification and
that has received temporary accreditation for one year by an approved
accreditation body. The one-year accreditation period is to allow the
OTP to address areas of non-conformance with accreditation standards
that do not involve immediate, high-risk health and/or safety concerns.
Continuous medication treatment means the uninterrupted treatment
for OUD involving the dispensing and administration of MOUD at stable
dosage levels for a period in excess of 21 days.
Covered medications means the medications or combinations of such
medications that are covered under 21 U.S.C. 823(g)(2)(C).
Dispense means to deliver a controlled medication to an ultimate
user by, or pursuant to, the lawful order of, a practitioner, including
the prescribing and administering of a controlled medication.
Diversion control plan means a set of documented procedures that
reduce the possibility that controlled medications will be transferred
or otherwise shared with others to whom the medication was not
prescribed or dispensed.
Emergency situation means that an existing State, tribal, or local
system for substance use disorder services is overwhelmed or unable to
meet the existing need for the provision of MOUD as a direct
consequence of a clear precipitating event. This precipitating event
must have an abrupt onset, such as: practitioner incapacity; natural or
human-caused disaster; an outbreak associated with drug use; and result
in significant death, injury, exposure to life-threatening
circumstances, hardship, suffering, loss of property, or loss of
community infrastructure.
Federal Opioid Use Disorder treatment standards means the standards
established by the Secretary in Sec. 8.12 that are used to determine
whether an OTP is qualified to engage in OUD treatment. The Federal
Opioid Use Disorder treatment standards established in Sec. 8.12 also
include the standards established by the Secretary regarding the
quantities of MOUD which may be provided for unsupervised use.
For-cause inspection means an inspection, by the Secretary, an
accreditation body, or a State authority, of an OTP that may be
operating in violation of Federal Opioid Use Disorder treatment
standards, may be providing substandard treatment, may be serving as a
possible source of diverted medications, or where patient well-being is
at risk.
Harm reduction refers to practical, evidence-based strategies,
including: overdose education; testing and intervention for infectious
diseases,

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including counseling and risk mitigation activities forming part of a
comprehensive, integrated approach to address human immunodeficiency
virus (HIV), viral hepatitis, sexually transmitted infections, and
bacterial and fungal infections; distribution of opioid overdose
reversal medications; linkage to other public health services; and
connecting those who have expressed interest in additional support to
peer services.
Individualized dose means the dose of a medication for opioid use
disorder, ordered by an OTP practitioner and dispensed to a patient,
that sufficiently suppresses opioid withdrawal symptoms. Individualized
doses may also include split doses of a medication for opioid use
disorder, where such dosing regimens are indicated.
Interim treatment means that on a temporary basis, a patient may
receive services from an OTP, while awaiting access to more
comprehensive treatment services. The duration of interim treatment is
limited to 180 days.
Long-term care facilities mean those facilities that provide
rehabilitative, restorative, and/or ongoing services to those in need
of assistance with activities of daily living. Long-term care
facilities include: extended acute care facilities; rehabilitation
centers; skilled nursing facilities; permanent supportive housing;
assisted living facilities; and chronic care hospitals.
Medical director means a physician, licensed to practice medicine
in the jurisdiction in which the OTP is located, who assumes
responsibility for all medical and behavioral health services provided
by the program, including their administration. A medical director may
delegate specific responsibilities to authorized program physicians,
appropriately licensed non-physician practitioners with prescriptive
authority functioning under the medical director's supervision, or
appropriately licensed and/or credentialed non-physician healthcare
professionals providing services in the OTP, in compliance with
applicable Federal and State laws. Such delegations will not eliminate
the medical director's responsibility for all medical and behavioral
health services provided by the OTP.
Medication for Opioid Use Disorder or MOUD means medications,
including opioid agonist medications, approved by the Food and Drug
Administration under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355), for use in the treatment of OUD. As used
in this part, ``continuous medication treatment'' is intended to be
synonymous with the term ``maintenance'' treatment as used in 21 U.S.C.
823(g)(1), and the term ``withdrawal management'' is intended to be
synonymous with the term ``detoxification'' as used in 21 U.S.C.
823(g)(1).
Medication unit means an entity that is established as part of, but
geographically separate from, an OTP from which appropriately licensed
OTP practitioners, contractors working on behalf of the OTP, or
community pharmacists may dispense or administer MOUD, collect samples
for drug testing or analysis, or provide other OTP services. Medication
units can be a brick-and-mortar location or mobile unit.
Nationally recognized evidence-based guidelines mean a document
produced by a national or international medical professional
association, public health agency, such as the World Health
Organization, or governmental body with the aim of assuring the
appropriate use of evidence to guide individual diagnostic and
therapeutic clinical decisions for the management of OUD and other
health conditions that are widely recognized within the United States.
Opioid Treatment Program or OTP means a program engaged in OUD
treatment of individuals with MOUD registered under 21 U.S.C.
823(g)(1).
Opioid Treatment Program certification means the process by which
the Secretary determines that an OTP applicant is qualified to provide
Opioid Use Disorder treatment under the Federal Opioid Use Disorder
treatment standards described in Sec. 8.12.
Opioid Use Disorder means a cluster of cognitive, behavioral, and
physiological symptoms associated with a problematic pattern of opioid
use that continues despite clinically significant impairment or
distress within a 12-month period.
Opioid Use Disorder treatment means the dispensing of MOUD, along
with the provision of a range of medical and behavioral health
services, as clinically necessary and based on an individualized
assessment and a mutually agreed-upon care plan, to an individual to
alleviate the combination of adverse medical, psychological, or
physical effects associated with an OUD.
Patient, for purposes of subparts B through D of this part, means
any individual who receives continuous treatment or withdrawal
management in an OTP. The word patient encompasses client, person in
treatment, or any other definition accepted by the treatment community
or those with lived experience. For purposes of subpart F of this part,
patient means any individual who is dispensed or prescribed covered
medications by a practitioner.
Patient limit means the maximum number of individual patients that
a practitioner may dispense or prescribe covered medications to at any
one time.
Physical and behavioral health services include services such as
medical and psychiatric screening, assessments, evaluations,
examinations, and interventions, counseling, health education, peer
support services, and social services (e.g., vocational and educational
guidance, employment training), that are intended to help patients in
OTPs achieve and sustain remission and recovery.
Practitioner, for purposes of this subpart and subparts B through D
of this part, means a physician, physician assistant, nurse
practitioner, clinical nurse specialist, certified registered nurse
anesthetist, or certified nurse midwife who is appropriately licensed
by a State to prescribe and/or dispense medications for opioid use
disorder within an OTP. The term practitioner, for purposes of subpart
F of this part, means a physician, physician assistant, nurse
practitioner, clinical nurse specialist, certified registered nurse
anesthetist, or certified nurse midwife who is appropriately licensed
by a State to prescribe and/or dispense schedule III, IV, and V
medications for opioid use disorder, and who possesses a waiver under
21 U.S.C. 823(g)(2).
Practitioner incapacity means the inability of a practitioner as a
result of an involuntary event to physically or mentally perform the
tasks and duties required to provide OUD treatment in accordance with
nationally recognized evidence-based guidelines.
Program sponsor means the person named in the application for
certification described in Sec. 8.11(b) as responsible for the
operation of the OTP and who assumes responsibility for all its
employees, including any practitioners, agents, or other persons
providing medical, behavioral health, or social services at the program
or any of its medication units. The program sponsor need not be a
licensed physician but shall ensure that an actively licensed physician
occupies the position of medical director within an OTP.
Recovery support services means:
(1) Recovery is the process of change through which people improve
their health and wellness, live self-directed lives, and strive to
reach their full potential.
(2) Recovery support services can include, but are not limited to,
community-based recovery housing,

[[Page 77352]]

peer recovery support services, social support, linkage to and
coordination among allied service providers and a full range of human
services that facilitate recovery and wellness contributing to an
improved quality of life. The services extend the continuum of care by
strengthening and complementing substance use disorder (SUD) treatment
interventions in different settings and stages.
Split dosing means dispensing of a single dose of MOUD as separate
portions to be taken within a 24-hour period. Split dosing is indicated
among, but not limited to, those patients who: possess a genetic
variant which increases methadone metabolism; concurrently use other
medications or alcohol that also induce hepatic enzymes leading to more
rapid metabolism of methadone; who are pregnant; or for whom methadone
or buprenorphine are being used to treat a concurrent pain indication
in addition to the diagnosis of OUD. This leads to more stable, steady-
state medication levels.
State Opioid Treatment Authority (SOTA) is the agency designated by
the Governor of a State, or other appropriate official designated by
the Governor, to exercise the responsibility and authority within the
State or Territory for governing the treatment of OUD with MOUD in
OTPs.
Telehealth or telemedicine is the delivery and facilitation of
health and health-related services including medical care, counselling,
practitioner, provider and patient education, health information
services, and self-care via telecommunications and digital
communication technologies. This includes Health Insurance Portability
and Accountability Act (HIPAA)-compliant video and audio-only
communication platforms.
Withdrawal management means the dispensing of a MOUD in decreasing
doses to an individual to alleviate adverse physical effects incident
to withdrawal from the continuous or sustained use of an opioid and as
a method of bringing the individual to an opioid-free state within such
period. Long-term withdrawal management refers to the process of
medication tapering that exceeds 30 days.

Subpart B--Accreditation of Opioid Treatment Programs

Sec. 8.3 Application for approval as an accreditation body.

(a) Eligibility. Private nonprofit organizations, State or
territorial governmental entities, or political subdivisions thereof,
and Indian Tribes as defined by the Federally Recognized Indian Tribe
List Act of 1994, that are capable of meeting the requirements of this
part may apply for approval as an accreditation body.
(b) Application for initial approval. Electronic copies of an
accreditation body application form [SMA-167] shall be submitted to:
<a href="https://dpt2.samhsa.gov/sma163/">https://dpt2.samhsa.gov/sma163/</a>. Accreditation body applications shall
include the following information and supporting documentation:
(1) Name, address, and telephone number of the applicant and a
responsible official for the accreditation body. The application shall
be signed by the responsible official;
(2) Evidence of the nonprofit status of the applicant (i.e., of
fulfilling Internal Revenue Service requirements as a nonprofit
organization) if the applicant is not a State or territorial
governmental entity, Indian Tribe, or political subdivision;
(3) A set of the accreditation elements or standards and a detailed
discussion showing how the proposed accreditation elements or standards
will ensure that each OTP surveyed by the applicant is qualified to
meet or is meeting each of the Federal opioid treatment standards set
forth in Sec. 8.12;
(4) A detailed description of the applicant's decision-making
process, including:
(i) Procedures for initiating and performing onsite accreditation
surveys of OTPs;
(ii) Procedures for assessing OTP personnel qualifications;
(iii) Copies of an application for accreditation, guidelines,
instructions, and other materials the applicant will send to OTPs
during the accreditation process, including a request for a complete
history of prior accreditation activities and a statement that all
information and data submitted in the application for accreditation is
true and accurate, and that no material fact has been omitted;
(iv) Policies and procedures for notifying OTPs and the Secretary
of deficiencies, for monitoring corrections of deficiencies by OTPs and
for reporting corrections to the Secretary;
(v) Policies and procedures for determining OTPs level of adherence
to this part and accrediting body standards and level of accreditation;
(vi) Policies and procedures for suspending or revoking an OTP's
accreditation;
(vii) Policies and procedures that will ensure processing of
applications for accreditation and applications for renewal of
accreditation within a timeframe approved by the Secretary; and
(viii) A description of the applicant's appeals process to allow
OTPs to contest adverse accreditation decisions;
(5) Policies and procedures established by the accreditation body
to avoid conflicts of interest, or the appearance of conflicts of
interest, by the applicant's board members, commissioners, professional
personnel, consultants, administrative personnel, and other
representatives;
(6) A description of the education, experience, and training
requirements for the applicant's professional staff, accreditation
survey team membership, and the identification of at least one licensed
physician with experience treating OUD with MOUD on the applicant's
staff;
(7) A description of the applicant's survey team training policies;
(8) Fee schedules, with supporting cost data;
(9) Satisfactory assurances that the body will comply with the
requirements of Sec. 8.4, including a contingency plan for
investigating complaints under Sec. 8.4(e);
(10) Policies and procedures established to protect confidential
information the applicant will collect or receive in its role as an
accreditation body; and
(11) Any other supporting information the Secretary may require.
(c) Application for renewal of approval. An accreditation body that
intends to continue to serve as an accreditation body beyond its
current term shall apply to the Secretary for renewal, or notify the
Secretary of its intention not to apply for renewal, in accordance with
the following procedures and schedule:
(1) At least 9 months before the date of expiration of an
accreditation body's term of approval, the body shall inform the
Secretary in writing of its intent to seek renewal.
(2) The Secretary will notify the applicant of the relevant
information, materials, and supporting documentation required under
paragraph (b) of this section that the applicant shall submit as part
of the renewal procedure.
(3) At least 3 months before the date of expiration of the
accreditation body's term of approval, the applicant shall send to the
Secretary electronically a renewal application containing the
information, materials, and supporting documentation requested by the
Secretary under paragraph (c)(2) of this section.
(4) An accreditation body that does not intend to renew its
approval shall so

[[Page 77353]]

notify the Secretary at least 9 months before the expiration of the
body's term of approval.
(d) Rulings on applications for initial approval or renewal of
approval. (1) the Secretary will grant an application for initial
approval or an application for renewal of approval if it determines the
applicant substantially meets the accreditation body requirements of
this subpart.
(2) If the Secretary determines that the applicant does not
substantially meet the requirements set forth in this subpart, the
Secretary will notify the applicant of the deficiencies in the
application and request that the applicant resolve such deficiencies
within 90 days of receipt of the notice. If the deficiencies are
resolved to the satisfaction of the Secretary within the 90-day time
period, the body will be approved as an accreditation body. If the
deficiencies have not been resolved to the satisfaction of the
Secretary within the 90-day time period, the application for approval
as an accreditation body will be denied.
(3) If the Secretary does not reach a final decision on a renewal
application before the expiration of an accreditation body's term of
approval, the approval will be deemed extended until the Secretary
reaches a final decision, unless an accreditation body does not rectify
deficiencies in the application within the specified time period, as
required in paragraph (d)(2) of this section.
(e) Relinquishment of approval. An accreditation body that intends
to relinquish its accreditation approval before expiration of the
body's term of approval shall submit a letter of such intent to the
Secretary, at the address in paragraph (b) of this section, at least 9
months before relinquishing such approval.
(f) Notification. An accreditation body that does not apply for
renewal of approval, or is denied such approval by the Secretary,
relinquishes its accreditation approval before expiration of its term
of approval, or has its approval withdrawn, shall:
(1) Transfer copies of records and other related information as
required by the Secretary to a location, including another
accreditation body, and according to a schedule approved by the
Secretary; and
(2) Notify, in a manner and time period approved by the Secretary,
all OTPs accredited or seeking accreditation by the body that the body
will no longer have approval to provide accreditation services.
(g) Term of approval. An accreditation body's term of approval is
for a period not to exceed 5 years.
(h) State, territorial, or Indian Tribe accreditation bodies.
State, territorial, and Indian Tribe entities, including political
subdivisions thereof, may establish organizational units that may act
as accreditation bodies, provided such units meet the requirements of
this section, are approved by the Secretary under this section, and
have taken appropriate measures to prevent actual or apparent conflicts
of interest, including cases in which State or Federal funds are used
to support MOUD.

Sec. 8.4 Accreditation body responsibilities.

(a) Accreditation surveys and for cause inspections. (1)
Accreditation bodies shall conduct routine accreditation surveys for
initial accreditation, and then at least every three years to allow for
renewal of certification.
(2) Accreditation bodies must agree to conduct for-cause
inspections upon the request of the Secretary.
(3) Accreditation decisions shall be fully consistent with the
policies and procedures submitted as part of the approved accreditation
body application.
(b) Response to noncompliant programs. (1) If an accreditation body
receives or discovers information that suggests that an OTP is not
meeting applicable accreditation or certification standards established
or authorized under this part, or if a survey of the OTP by the
accreditation body demonstrates that such standards are not being met,
the accreditation body shall either require and monitor corrective
action or shall suspend or revoke accreditation of the OTP, as
appropriate based on the significance of the deficiencies.
(i) Accreditation bodies shall either not accredit or shall revoke
the accreditation of any OTP that substantially fails to meet the
Federal Opioid Use Disorder treatment standards.
(ii) Accreditation bodies shall notify the Secretary as soon as
possible but in no case longer than 48 hours after becoming aware of
any practice or condition in an OTP that may pose a serious risk to
public health or safety or patient care.
(iii) If an accreditation body determines that an OTP is meeting
the Federal Opioid Use Disorder treatment standards, as defined in
Sec. 8.12, but is not meeting one or more accreditation elements
within 60 days of survey completion, the accreditation body shall
determine the necessary corrective measures to be taken by the OTP,
establish a schedule for implementation of such measures not to exceed
60 days, and notify the OTP in writing that it must implement such
measures within the specified schedule in order to ensure continued
accreditation. The accreditation body shall verify that the necessary
corrective measures are implemented by the OTP within the schedule
specified and that all accreditation elements are met within the
specified schedule. Within 60 days after the specified schedule for
implementation, the accreditation body will notify the Secretary, in
writing, whether or not the OTP has completed the corrective measures.
(2) Nothing in this part shall prevent accreditation bodies from
granting accreditation, contingent on the implementation of
programmatic or performance changes, to OTPs with less substantial
violations. Less substantial violations refers to non-conformance with
accreditation standards that do not involve immediate, high-risk health
and safety concerns. Such accreditation shall not exceed 12 months
during which time a resurvey or reinspection must occur to determine
whether the applicable changes have been implemented. OTPs that have
been granted such accreditation must have their accreditation revoked
if they fail to implement the applicable changes upon resurvey or
reinspection.
(c) Recordkeeping. (1) Accreditation bodies shall maintain, and
make available as requested by the Secretary, records of their
accreditation activities for at least 5 years from the creation of the
record. Such records must contain sufficient detail to support each
accreditation decision made by the accreditation body.
(2) Accreditation bodies shall establish procedures to protect
confidential information collected or received in their role as
accreditation bodies that are consistent with, and that are designed to
ensure compliance with, all Federal and State laws, including 42 CFR
part 2.
(i) Information collected or received for the purpose of carrying
out accreditation body responsibilities shall not be used for any other
purpose or disclosed, ot

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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.