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Rule2024-01693

Medications for the Treatment of Opioid Use Disorder

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Published

February 2, 2024

Effective

April 2, 2024

Issuing agencies

Health and Human Services Department

Abstract

This final rule modifies and updates certain provisions of regulations related to Opioid Treatment Program (OTP) accreditation, certification, and standards for the treatment of Opioid Use Disorder (OUD) with Medications for Opioid Use Disorder (MOUD) in OTPs. This includes making flexibilities put forth during the COVID-19 Public Health Emergency (PHE) permanent, as well as expanding access to care and evidence-based treatment for OUD. The final rule also removes all language and rules pertaining to the Drug Addiction and Treatment Act (DATA) Waiver from the regulations pursuant to the "Consolidated Appropriations Act, 2023".

Full Text

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<title>Federal Register, Volume 89 Issue 23 (Friday, February 2, 2024)</title>
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[Federal Register Volume 89, Number 23 (Friday, February 2, 2024)]
[Rules and Regulations]
[Pages 7528-7563]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-01693]

[[Page 7527]]

Vol. 89

Friday,

No. 23

February 2, 2024

Part IV

Department of Health and Human Services

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42 CFR Part 8

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Medications for the Treatment of Opioid Use Disorder; Final Rule

Federal Register / Vol. 89 , No. 23 / Friday, February 2, 2024 /
Rules and Regulations

[[Page 7528]]

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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 (``HHS'' or ``the
Department'').

ACTION: Final rule.

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SUMMARY: This final rule modifies and updates certain provisions of
regulations related to Opioid Treatment Program (OTP) accreditation,
certification, and standards for the treatment of Opioid Use Disorder
(OUD) with Medications for Opioid Use Disorder (MOUD) in OTPs. This
includes making flexibilities put forth during the COVID-19 Public
Health Emergency (PHE) permanent, as well as expanding access to care
and evidence-based treatment for OUD. The final rule also removes all
language and rules pertaining to the Drug Addiction and Treatment Act
(DATA) Waiver from the regulations pursuant to the ``Consolidated
Appropriations Act, 2023''.

DATES: The effective date of this final rule is April 2, 2024, and the
compliance date is October 2, 2024.

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#570538353225237915363e3b3b3e32221724363a3f2436793f3f2479303821">[email&#160;protected]</a>.

SUPPLEMENTARY INFORMATION: The discussion below includes an Executive
Summary and overview describing the rule, responses to public comments,
an impact statement, and other required regulatory analyses.

Executive Summary

A. Overview

This regulation finalizes the Department's proposed rule concerning
Medications for the Treatment of Opioid Use Disorder published in the
Federal Register on December 16, 2022 (87 FR 77330). It also finalizes
proposals found in the Department's supplemental notice of proposed
rulemaking concerning removal of the DATA-2000 Waiver requirements
issued in the Federal Register on February 13, 2023 (88 FR 9221). The
final rule makes changes to the Department's existing regulations
concerning OTPs at 42 CFR part 8.
The Controlled Substances Act (CSA), under 21 U.S.C. 823(h)(1)-(3),
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.'' \1\
The Secretary's standards authorized under section 823(h) have been
published as regulations under part 8 of title 42 of the Code of
Federal Regulations (``42 CFR part 8'' or ``part 8'').\2\ 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.\3\ 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(h)(1)'' is described as an ``Opioid Treatment Program'' (OTP).\4\
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\1\ See 21 U.S.C. 823(h)(1)-(3).
\2\ 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.
\3\ See 42 CFR 8.1
\4\ 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''.
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On December 29, 2022, the `Consolidated Appropriations Act, 2023'
(Pub. L. No: 117-328) was enacted, resulting in the removal of
requirements to obtain a waiver from the registration requirements of
21 U.S.C. 823(h)(1) for qualifying practitioners seeking to dispense or
prescribe schedule III, IV, or V controlled substances that are FDA-
approved for use in ``maintenance and detoxification treatment.''
Practitioners with a waiver under section 823(h)(2) were limited in the
number of patients with OUD they may treat at any one time, and
depending on the practitioner's experience or qualifications, this
statutory limitation was set at either 30, 100, or 275.\5\ The
Secretary was also authorized to change the patient limitations by
regulation, and qualifying practitioners had to satisfy the
requirements of 42 CFR 8.610 through 8.655 ``(or successor
regulations)'' in order to treat up to 275 patients, which was the
maximum number under the law.\6\
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\5\ Formally under 21 U.S.C. 823(h)(2)(B)(iii)
\6\ Formally under 21 U.S.C. 823(h)(2)(B)(iii)(II)(dd). 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 final rule, the Department modifies certain provisions of
part 8 to update OTP accreditation and certification standards, as well
as treatment standards for the provision of medications for opioid use
disorder (MOUD) as dispensed by OTPs. Pursuant to the `Consolidated
Appropriations Act, 2023' (Pub. L. No: 117-328), the final rule also
removes language pertaining to requirements for individual
practitioners to dispense (including by prescribing) certain types of
MOUD with a waiver under 21 U.S.C. 823(h)(2). SAMHSA has developed this
final rule in consultation with the Drug Enforcement Administration.
The final rule 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 physical
distancing and to preserve patient and OTP staff safety. In March 2020,
SAMHSA published guidance regarding flexibilities that could be
leveraged in the provision of unsupervised doses of methadone and the
use of telehealth when initiating buprenorphine.\7\ These flexibilities
represented the first substantial change to OTP treatment and
medication delivery standards in more than 20 years, and their role in
facilitating access to treatment is supported by research.
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\7\ 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 final rule not only makes these COVID-19-related flexibilities
permanent, but also updates standards

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to reflect an accreditation and treatment environment that has evolved
since part 8 went into effect in 2001. Accordingly, the Department is
updating part 8 to promote practitioner autonomy; remove discriminatory
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.8 9 10
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\8\ 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.
\9\ 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.
\10\ 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 practitioner has been modified to
refer to a provider who is appropriately licensed by the State to
prescribe (including dispense) medications. Admission criteria have
been updated, as required by section 1252(b) of the `Consolidated
Appropriations Act, 2023', to remove significant barriers to entry,
such as the one-year requirement for opioid use disorder (OUD),\11\
while also defining the scope and purpose of the `initial' and
`periodic' medical examinations. The final rule also includes new
definitions to expand access to evidence-based practices such as split
dosing, telehealth and harm reduction activities. In addition, outdated
terms such as `detoxification' have been revised to remove stigmatizing
language.
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\11\ See 42 CFR 8.12(e)(1).
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The Department promotes practitioner autonomy and individualized
care by finalizing the provision containing the criteria for
unsupervised doses of methadone. This includes removal from sole
consideration the length of time an individual has been in treatment
and requirements for 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 change recognizes the importance of the
practitioner-patient relationship and is consistent with modern
substance use disorder treatment standards.\12\ It also allows for
greater flexibility in creating plans of care that promote recovery
activities such as employment or education, while also eliminating the
barrier of frequent OTP visits for individuals without access to
reliable transportation.\13\
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\12\ 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.
\13\ 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 updated to
codify the use of online/electronic forms, and to reflect a modern
treatment environment. 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 final rule also clarifies
administrative issues pertaining to accreditation, mobile medication
units and interim treatment.
This final rule makes treatment in OTPs more accessible to
patients, while also supporting evidence-based and patient-centered
care. In creating these changes, SAMHSA has relied on published
evidence, stakeholder feedback, public comments to the proposed rule
and the need to expand access to care in the face of a growing overdose
epidemic, exacerbated by the COVID-19 pandemic.\14\ This is brought
further into focus by the HHS declaration of a public health emergency
for the opioid crisis which has been renewed regularly since 2017.\15\
While the COVID-19 public health emergency expired as of May 11,
2023,\16\ the lessons learned from the COVID-19 pandemic remain
relevant for ensuring access to safe and effective substance use
disorder treatment. The changes created by this final rule are
expansive but are focused on permanently implementing the existing
flexibilities and updating policies and practices that are based on
evidence. In this way, SAMHSA believes that much of what is contained
in the rule will not represent a significant burden for OTPs and, in
fact, will reduce burdens and confer many benefits to providers and
patients. The final rule, therefore, supports OTPs in their on-going
provision of equitable and evidence-based care to often marginalized
patients with OUD. The final rule also is consistent with the HHS
Overdose Prevention Strategy and the National Drug Control Strategy,
both of which call for increasing access to and the uptake of evidence-
based treatments for substance use disorders.\17\
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\14\ 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.
\15\ 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>.
\16\ See <a href="https://www.hhs.gov/about/news/2023/05/09/fact-sheet-end-of-the-covid-19-public-health-emergency.html">https://www.hhs.gov/about/news/2023/05/09/fact-sheet-end-of-the-covid-19-public-health-emergency.html</a>
\17\ See <a href="https://www.hhs.gov/overdose-prevention/">https://www.hhs.gov/overdose-prevention/</a>. See also
<a href="https://www.whitehouse.gov/briefing-room/statements-releases/2022/04/21/fact-sheet-white-house-releases-2022-national-drug-control-strategy-that-outlines-comprehensive-path-forward-to-address-addiction-and-the-overdose-epidemic/">https://www.whitehouse.gov/briefing-room/statements-releases/2022/04/21/fact-sheet-white-house-releases-2022-national-drug-control-strategy-that-outlines-comprehensive-path-forward-to-address-addiction-and-the-overdose-epidemic/</a>
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B. Background

As of June 2023, there are over 2,000 OTPs in the United States,
providing care to over 650,000 patients.\18\ These are the only
settings within which methadone, a schedule II opioid receptor agonist,
can be legally provided to patients with OUD outside the context of
hospital admission or certain other special circumstances.\19\
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\18\ Data from the U.S. Department of Health and Human Services,
Treatment Locator, at <a href="https://findtreatment.gov/">https://findtreatment.gov/</a>
\19\ See 21 CFR 1306.07.
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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. Such medications include methadone, buprenorphine, a
schedule III partial opioid receptor agonist, and naltrexone which is
an opioid receptor antagonist. For purposes of certification, OTPs must
also offer adequate medical, counseling, vocational, educational, as
well as other assessment and treatment services either onsite or by
referral to an outside entity or practitioner.\20\
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\20\ 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.
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Practitioners treating OUD and the OTPs in which they practice must
continuously adapt to evolving patterns of drug misuse. This is
increasingly

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complicated by changes in controlled medication 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.\21\ By 2010, however, the U.S. began to see rapid
increases in overdose deaths involving heroin \22\ and then by 2013,
synthetic opioids other than methadone--primarily illicitly
manufactured fentanyl--contributed to a further rise in overdose-
related deaths.23 24 The introduction of xylazine into the
illicit drug supply and its associated harms further adds to an
evolving, complex, and dangerous situation.\25\
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\21\ 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.
\22\ 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.
\23\ 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.
\24\ 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.
\25\ See <a href="https://www.samhsa.gov/sites/default/files/colleague-letter-xylazine.pdf">https://www.samhsa.gov/sites/default/files/colleague-letter-xylazine.pdf</a>.
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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 109,940 Americans
died from a drug overdose in the 12-month period ending in January
2023.\26\ 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.\27\ 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.\28\ 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
adverse patient and public health outcomes.
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\26\ Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional
drug overdose death counts. National Center for Health Statistics.
2023.
\27\ Wide-ranging online data for epidemiologic research
(WONDER). Atlanta, GA: CDC, National Center for Health Statistics;
2023. Available at <a href="http://wonder.cdc.gov">http://wonder.cdc.gov</a>.
\28\ Ibid.
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C. 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 at that time) in treatment and withdrawal management
(referred to as detoxification at that time) of OUD. The final rule
repealed the treatment regulations enforced by the Food and Drug
Administration (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 1995 study, `Federal Regulation of Methadone
Treatment' \29\ 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. 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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\29\ For full text, see: <a href="https://www.ncbi.nlm.nih.gov/books/NBK232108/">https://www.ncbi.nlm.nih.gov/books/NBK232108/</a>
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To address these recommendations, SAMHSA proposed a
``certification'' system based on accreditation. Under the system, an
applicant organization 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 organization 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 addressed accreditation and includes
steps that Accreditation Bodies must follow to achieve approval to
accredit OTPs. It also set forth the Accreditation Bodies'
responsibilities, including the use of accreditation elements during
accreditation surveys. Subpart C described the sequence and
requirements for obtaining certification and addressed how and when
programs must apply for initial certification and renewal of their
certification. Subpart D elucidated the procedures for review of the
withdrawal of approval of the Accreditation Body or the suspension and
proposed revocation of an OTP certification.
Since publication of the final rule in 2001, it has been updated on
occasion to include new medications, such as buprenorphine, while also
updating or adding new rules governing the provision of such
medications. Subpart F, added in 2016, described criteria for
increasing the patient limit for those practitioners meeting Federal
requirements to prescribe buprenorphine to 275.\30\
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\30\ 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>.
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On December 29, 2022, the `Consolidated Appropriations Act, 2023'
(Pub. L. No: 117-328), was signed into law and immediately eliminated
the requirement for individual practitioners to obtain a waiver to
prescribe certain schedule III--V medications for the treatment of OUD,
commonly known as the ``DATA-Waiver.'' Before the Consolidated
Appropriations Act, 2023 was enacted, ``qualifying practitioners'' were
required to obtain waivers (formerly under 21 U.S.C. 823(h)(2))

[[Page 7531]]

from the separate DEA registration requirement, under 21 U.S.C. 823(h),
that is needed to enable dispensing of certain controlled medications
used in maintenance or withdrawal management (``detoxification'')
treatment of OUD. Section 1252(b) of the `Consolidated Appropriations
Act, 2023' (Pub. L. No: 117-328) also required removal of the one-year
history of opioid misuse prior to admission to an OTP. This was
included in the part 8 NPRM (87 FR 77330), and public comments
supported the change.
In 2001 there were close to 900 OTPs, but that number has grown to
over 2,000 by 2023.\31\ Over this period, the incidence of fentanyl
misuse has increased, escalating with the onset of the COVID-19
pandemic 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 take-home doses of methadone and
initiation of buprenorphine via telehealth, including through audio-
only platforms, that allowed for continued treatment of OUD with
reduced direct patient contact. Each of these flexibilities represented
a significant change to previous treatment standards and are discussed
in detail below. It is important to note that SAMHSA has issued
extensions to both the initiation of buprenorphine via telehealth
flexibility and methadone take-home flexibility, effective upon
expiration of the COVID-19 Public Health Emergency, and in effect for
the period of one year from the end of the COVID-19 Public Health
Emergency, or until such time that the U.S. Department of Health and
Human Services publishes final rules revising 42 C.F.R part 8,
whichever occurs sooner.\32\
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\31\ SAMHSA treatment locator. See <a href="https://dpt2.samhsa.gov/treatment/directory.aspx">https://dpt2.samhsa.gov/treatment/directory.aspx</a>.
\32\ See <a href="https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/methadone-guidance">https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/methadone-guidance</a>; and
<a href="https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/buprenorphine-at-opioid-treatment-programs">https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/buprenorphine-at-opioid-treatment-programs</a>
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Flexibility For Methadone Medication Take-Home Doses 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-home doses 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.\33\ These criteria can pose disruption to employment,
education and other daily activities for patients, and several of the
criteria reflect outdated biases that promote stigma and discourage
people from engaging in care in OTPs.
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\33\ <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>.
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In March 2020, as a result of the pandemic, SAMHSA issued
exemptions that permitted 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.\34\ With this
flexibility, SAMHSA allowed OTPs to dispense up to 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.'' \35\ 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 . . . .'' \36\
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\34\ 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>.
\35\ 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>.
\36\ 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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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 may 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, attend school, 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,\37\ OTPs,\38\ and State authorities.\39\
Patients reported that increased take-home doses of methadone left them
feeling more respected as responsible individuals.37 40 In a
national meeting, State authorities reported that the flexibilities
were appreciated by patients and OTPs alike, with no significant change
in rates of diversion seen since the COVID-19 PHE was declared.\41\
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.\42\
Additionally, a survey found that diversion of methadone is low among
patients receiving take-home doses under the COVID-19 PHE
flexibility.43 44 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.\45\
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\37\ 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.
\38\ 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.
\39\ ``To Save Lives From Opioid Overdose Deaths, Bring
Methadone Into Mainstream Medicine'', Health Affairs Forefront, May
27, 2022.
\40\ Krawczyk, N., Rivera, B. D., Levin, E., & Dooling, B. C. E.
(2023). Synthesizing evidence of the effects of COVID-19 regulatory
changes on methadone treatment for opioid use disorder: implications
for policy. The Lancet. Public health, 8(3), e238-e246. <a href="https://doi.org/10.1016/S2468-2667">https://doi.org/10.1016/S2468-2667</a>(23)00023-3
\41\ The 2022 American Association for the Treatment of Opioid
Dependence (AATOD) Conference, Baltimore, Maryland, October 30--
November 3, 2022.
\42\ 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>.
\43\ 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>.
\44\ 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>.
\45\ 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>.

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[[Page 7532]]

Recognizing the importance of this flexibility, SAMHSA released
guidance on November 18, 2021, (subsequently updated on April 19, 2023)
\46\ that extended the methadone take-home flexibility for one year
past the end of COVID-19 PHE (May 11, 2024), or until such time that
the Department publishes this final rule, whichever occurs sooner.
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\46\ See <a href="https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/methadone-guidance">https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/methadone-guidance</a>
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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.47 48 49 Between 2016 and 2019, use of
telehealth, in general, doubled from 14 to 28 percent \50\ while
substance use disorder (SUD) treatment, offered through telehealth over
the same period, increased from 13.5 to 17.4 percent.\51\ This trend
has rapidly increased between 2019 and 2021, due to the COVID-19
pandemic.\52\
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\47\ 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.
\48\ Lustig, T. (2012). The role of telehealth in an evolving
health care environment: Workshop summary. National Academies Press.
\49\ 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.
\50\ 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>
\51\ 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.
\52\ 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.
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The pandemic spurred use of telehealth for the treatment of OUD
with 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.\53\
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\53\ 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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In response to the COVID-19 PHE, as declared by Secretary Azar on
January 31, 2020, pursuant to the authority under section 319 of the
Public Health Service Act (42 U.S.C. 247), the DEA granted temporary
exceptions to the Ryan Haight Act and DEA's implementing regulations
under 21 U.S.C. 802(54)(D), one of the seven distinct categories of
telemedicine envisioned under the statutory definition of the practice
of telemedicine. In order to prevent lapses in care, these exceptions
allowed for the prescribing of controlled medications via telemedicine
encounters even when the prescribing practitioner had not conducted an
in-person medical evaluation of the patient.
These telemedicine flexibilities authorized practitioners to
prescribe schedule II-V controlled medications via audio-video
telemedicine encounters, including schedule III-V narcotic controlled
medications approved by the Food and Drug Administration (FDA) for
maintenance and withdrawal management treatment of opioid use disorder
via audio-only telemedicine encounters, provided that such
prescriptions otherwise comply with the requirements outlined in DEA
guidance documents, DEA regulations, and applicable Federal and State
law. DEA granted those temporary exceptions to the Ryan Haight Act and
DEA's implementing regulations via two letters published in March 2020:
the March 25, 2020 ``Dear Registrant'' letter signed by William T.
McDermott, DEA's then-Assistant Administrator, Diversion Control
Division,\54\ and the March 31, 2020 ``Dear Registrant'' letter signed
by Thomas W. Prevoznik, DEA's then-Deputy Assistant Administrator,
Diversion Control Division.\55\
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\54\ William T. McDermott, DEA Dear Registrant letter, Drug
Enforcement Administration (March 25, 2020), <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.
\55\ Thomas W. Prevoznik, DEA Dear Registrant letter, Drug
Enforcement Administration (March 31, 2020), <a href="https://www.deadiversion.usdoj.gov/GDP/">https://www.deadiversion.usdoj.gov/GDP/</a>(DEA-DC-
022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Fina
l)%20+Esign.pdf
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Building upon this, SAMHSA implemented OTP regulatory flexibilities
designed to help address the impact of the COVID-19 pandemic on OTPs
and their patients.\56\ 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 was to 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, determined that an adequate evaluation of the patient could
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'',\57\ and the exemption did not
include induction of methadone via telehealth technology.
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\56\ OTPs are authorized to dispense narcotic maintenance and
detoxification medication under 21 U.S.C. 823(h)(1) and regulated
under 42 CFR part 8.
\57\ 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,\58\ and that among those patients requiring treatment with
buprenorphine, there are high levels of satisfaction with the use of
telehealth services.\59\ 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.\58\ \60\ Research also shows that there is no
significant difference in client and provider ratings of therapeutic
alliance when using telehealth technology platforms.\59\ Further to
this, research demonstrates that actions to facilitate access to
buprenorphine-based treatment for OUD during the COVID-19 pandemic were
not associated with an increased proportion of overdose deaths
involving buprenorphine.\61\
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\58\ 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.
\59\ 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.
\60\ 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>.
\61\ Tanz, L. J., Jones, C. M., Davis, N. L., Compton, W. M.,
Baldwin, G. T., Han, B., & Volkow, N. D. (2023). Trends and
Characteristics of Buprenorphine-Involved Overdose Deaths Prior to
and During the COVID-19 Pandemic. JAMA network open, 6(1), e2251856.
<a href="https://doi.org/10.1001/jamanetworkopen.2022.51856">https://doi.org/10.1001/jamanetworkopen.2022.51856</a>

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[[Page 7533]]

On May 9, 2023, SAMHSA issued guidance \62\ that extended the
buprenorphine telehealth flexibility for OTPs for one year past the end
of COVID-19 PHE, or until such time that the Department publishes this
final rule, whichever occurs sooner. 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. This final rule permits initiation of
buprenorphine at the OTP, by the OTP practitioner, if an OTP physician,
primary care physician, or other authorized healthcare professional
under the supervision of a program physician, determines that an
adequate evaluation of the patient can be, or was, accomplished via
audio-only or audio-visual telehealth technology.
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\62\ See: <a href="https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/buprenorphine-at-opioid-treatment-programs">https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/buprenorphine-at-opioid-treatment-programs</a>
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SAMHSA believes that evidence underlying the initiation of
buprenorphine using telehealth also is applicable 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.\63\ However, SAMHSA
also acknowledges that there are differences between these two
medications. Accordingly, this final 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 by the OTP 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 final rule is
not applicable to, and does not authorize, the prescription of
methadone pursuant to a telehealth visit. Instead, this 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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\63\ 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.
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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 audio-visual telehealth platforms
based on their disability has an equal opportunity to benefit from
treatment with MOUD. Similarly, Federal civil rights laws prohibit
discrimination on the basis of national origin (including language
ability) and require recipients to take reasonable steps to provide
meaningful access to LEP individuals. This 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 allowance 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.\64\ On September 21, 2021, SAMHSA released guidance on the
establishment of mobile and non-mobile medication units and allowable
services.\65\ While part 8 currently allows OTPs certified by SAMHSA to
establish medication units (as defined under 42 CFR 8.2), the final
rule further defines mobile units and clarifies potential services,
interventions and accreditation processes.
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\64\ See <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>.
\65\ 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 COVID-19 pandemic highlighted the importance of
providing harm reduction services to OTP patients. On April 7, 2021,
the CDC and SAMHSA jointly announced that Federal funding could be used
to purchase rapid fentanyl test strips (FTS) for drug checking
purposes.\66\ This was proposed in part 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.
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\66\ See <a href="https://www.samhsa.gov/newsroom/press-announcements/202104070200">https://www.samhsa.gov/newsroom/press-announcements/202104070200</a>
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On December 16, 2022, HHS issued a notice of proposed rulemaking
(NPRM) entitled `Medications for the Treatment of Opioid Use Disorder'
(87 FR 77330). In that NPRM, the Department proposed to modify certain
provisions of part 8 to update Opioid Treatment Program (OTP)
accreditation and certification standards, treatment standards for the
provision of medications for opioid use disorder as dispensed by OTPs,
and requirements for individual practitioners eligible to dispense
(including by prescribing) certain types of Medication for Opioid Use
Disorder (MOUD) with a waiver under 21 U.S.C. 823(h)(2). Proposed
changes sought to make flexibilities put forth during the COVID-19 PHE
permanent, and to also update standards to reflect an OTP accreditation
and treatment environment that has evolved since 42 CFR part 8 came
into effect in 2001. To this end, the Department proposed to update
part 8 by: removing outdated language; fostering a more patient-
centered perspective; and reducing barriers to receiving care. These
elements have been identified in the literature and in feedback as
being essential to promoting effective treatment and retention in care
provided by OTPs.
To expand access to care, the Department proposed to update OTP
admission criteria as described in 42 CFR part 8. This included removal
of the one-year requirement for opioid addiction before admission to an
OTP, in favor of consideration of problematic patterns of opioid use.
Indeed, evidence-based standards of care demonstrate that it is more
prudent to admit those individuals who either: meet diagnostic criteria
for active moderate to severe OUD; are in OUD remission; or are at high
risk for recurrence or overdose. In conjunction with updated standards
that include extended take-home doses of methadone and access to
telehealth, this is likely to

[[Page 7534]]

expand access while also improving retention in treatment.
Additionally, the Department proposed to update 42 CFR part 8 to
reflect evidence-based practice, treatment standards, and the workforce
currently providing services in OTPs. Proposed changes included:
expanding the definition of a treatment practitioner to include any
provider who is appropriately licensed to dispense and/or prescribe
approved medications; addition of evidence-based paradigms of care such
as split dosing, telehealth and harm reduction activities; removing
outdated terms such as `detoxification'; review of criteria for
provision of take-home doses of methadone; strengthening the patient-
practitioner relationship through promotion of shared and evidence-
based decision making; allowing for early access to take-home doses of
methadone for all patients to promote flexibility in creation of plans
of care that promote recovery activities such as employment or
education, while also allowing those with unstable access to reliable
transportation the opportunity to also receive treatment; promotion of
mobile medication units to expand an OTP's geographic reach; and review
accreditation standards. The proposed changes sought to organize
existing flexibilities and practice updates in a manner that makes them
permanent and cohesive.
Removal of DATA-Waiver Requirements
Section 1262(a)(1) of the Consolidated Appropriations Act, 2023
(Pub. L. No: 117-328), which was enacted on December 29, 2022, amended
the CSA (21 U.S.C. 823(h)) by eliminating the requirement that
practitioners obtain a waiver to prescribe certain schedule III--V
medications for the treatment of opioid use disorder (OUD). This
immediately removed the requirement for practitioners to submit a
notification of intent and to receive the Drug Addiction Treatment Act
of 2000 (DATA)-Waiver before prescribing buprenorphine.
Before the Consolidated Appropriations Act, 2023 was enacted,
``qualifying practitioners'' were required to obtain waivers (formerly
under 21 U.S.C. 823(h)(2)) from a separate registration requirement,
under 21 U.S.C. 823(h), that is needed to enable dispensing of certain
schedule II--V narcotic medications used in maintenance or
detoxification treatment. Practitioners with a waiver of this kind were
limited in the number of patients they could treat with this type of
medication at any one time.
In July 2016, SAMHSA published a final rule (81 FR 44711) that
added `subpart F' to 42 CFR part 8 under the authority of former 21
U.S.C. 823(h)(2)(B)(iii)(III). Among other things, subpart F authorized
eligible practitioners with a waiver under 21 U.S.C. 823(h)(2) to
request approval to treat up to 275 patients under certain conditions.
The December 16, 2022, NPRM entitled `Medications for the Treatment of
Opioid Use Disorder' (87 FR 77330), proposed three changes to subpart
F: (1) altering section headings to remove the current question-and-
answer style and replacing it with a standard format; (2) updating
Section 8.610 to remove stigmatizing language and to also clarify that
the 275-patient waiver is limited to three years in duration and; (3)
removing Section 8.635 to eliminate annual reporting requirements for
practitioners approved to treat up to 275 patients.
Pursuant to section 1262 of the Consolidated Appropriations Act,
2023, the Department published a supplemental notice of proposed
rulemaking (SNPRM), entitled `Medications for the Treatment of Opioid
Use Disorder: Removal of the DATA-2000 Waiver Requirements' (88 FR
9221), on February 13, 2023. This SNPRM proposed to remove in its
entirety subpart F of 42 CFR part 8 in addition to language throughout
42 CFR part 8 that specifically references or implicates the DATA-2000
waiver process.

D. Analysis and Discussion of Comments

On December 16, 2022, the Department published a notice of proposed
rulemaking entitled `Medications for the Treatment of Opioid Use
Disorder' (87 FR 77330). The public comment period ended on February
14, 2023, and a total of 373 comments were received. On February 13,
2023, the Department also released a supplemental NPRM entitled
`Medications for the Treatment of Opioid Use Disorder: Removal of the
DATA-2000 Waiver Requirements' (88 FR 9221), to bring proposed changes
to 42 CFR part 8 rule into alignment with the `Consolidated
Appropriations Act, 2023' (Pub. L. 116-260). The supplemental NPRM
closed for public comments on March 14, 2023. An additional 27 comments
were received, the majority of which pertained to the December 16,
2022, NPRM.
General Comments
Terminology Changes, and Reducing Stigma
Comments conveyed widespread approval of terminology and language
changes aimed at expanding care while also reducing stigmatization for
patients receiving treatment for OUD. Some commenters noted that
language changes alone will not be sufficient to eliminate, stigma,
injustice, and institutionalized marginalization. Others were concerned
that updated language was not accurate--for example, that it detracts
focus from other forms of treatment. One commenter additionally
suggested that SAMHSA and other authorities consider updating their
organizations' names to maintain consistency with destigmatizing
language changes. Such changes have been proposed by SAMHSA and
HHS,\67\ but not yet enacted by Congress as of this date.
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\67\ See <a href="https://www.samhsa.gov/sites/default/files/samhsa-fy-2024-cj.pdf">https://www.samhsa.gov/sites/default/files/samhsa-fy-2024-cj.pdf</a>.
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Another commenter suggested eliminating or reducing the
requirements for random toxicology testing as an important method to
further reduce stigma and loss of bodily autonomy among a population
that has often faced violent and punitive treatment. They also suggest
reexamining the differential regulation of methadone versus
buprenorphine.
Response: SAMHSA recognizes the role of language in perpetuating
stigma and discrimination, and is committed to taking steps to use
language that is positive, patient-centered, productive and inclusive.
It recognizes that changing language, alone, will not immediately
eliminate harms suffered by those struggling with and in recovery from
substance use disorders. SAMHSA and its Federal, State, local, Tribal
and territorial partners have been working to impact health equities
and promote justice through its programs, services and regulations, as
evidenced in the improvements made in this regulatory language. SAMHSA
has also emphasized support for recovery and recovery services.\68\ It
will take time to assure consistency of language throughout documents;
changing names of Federal agencies requires legislative action.
Toxicology testing is a clinical tool that is used to inform the
treatment process, should never be used punitively, and must be
conducted in a way that is respectful of the individual and in
accordance with clinical and

[[Page 7535]]

professional standards.\69\ Also, the different regulation of methadone
(in schedule II) versus buprenorphine (in schedule III) stems from how
these substances are scheduled and from how they are regulated under 21
U.S.C. 823(h), which requires ``practitioners who dispense narcotic
drugs (other than narcotic drugs in schedule III, IV, or V) to
individuals for maintenance treatment or detoxification treatment'' to
obtain an annual separate registration for that purpose.
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\68\ See <a href="https://www.samhsa.gov/find-help/recovery">https://www.samhsa.gov/find-help/recovery</a>?
\69\ See <a href="https://store.samhsa.gov/sites/default/files/d7/priv/pep15-fedguideotp.pdf">https://store.samhsa.gov/sites/default/files/d7/priv/pep15-fedguideotp.pdf</a>.
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Error in Citations
One commenter expressed concern that several cited research studies
were not accurately interpreted as used for this NPRM. For example,
citation 103 is used as justification for provision of counseling at
OTPs, but the study was done in a primary care setting. Another
commenter stated that the same reference, 103, is incorrect and the
citation in the body does not match the DOI link--one references HIV
testing in Africa while it appears they intend to reference the HSU
study on psychiatric comorbidity.
Response: SAMHSA made every effort to ensure that the citations
listed were correct. The error noted with citation 103 has been
rectified. Within the body of the text, the citation is appropriate as
the text explicitly describes this study and highlights that in
combination with other evidence, a comprehensive approach to treatment
is associated with improved outcomes. Indeed, the proposed rule also
includes evidence from other settings such as Emergency Departments. It
is important to note that economic analysis of OUD treatment
interventions is uncommon and so assessment of such evidence requires
consideration of all sources.
Comments on Accreditation Standards
One-Year Accreditation Following One Recommendation
Many commenters opposed the proposed change under Section 8.4, that
provides, based on their understanding, only one-year accreditations to
OTPs with recommendations. They believe this change in accreditation
regulations will essentially end three-year accreditations. Commenters
stated that with the number of standard ratable elements it is
unreasonable to expect facilities to meet every accreditation element.
With about 1,400 elements evaluated during each survey, not having even
one recommendation is an unobtainable standard for many OTPs.
Commenters stressed that having such a high standard would result in a
substantial number, if not all, of OTPs having to submit to an annual
accreditation inspection.
Response: Section 8.4 addresses the responsibilities of the
Accreditation Bodies. Since 2001, Section 8.4(b), in response to
noncompliant programs stated ``(1) If an Accreditation Body receives or
discovers information that suggests that an OTP is not meeting Federal
opioid use disorder treatment standards, or if survey of the OTP by the
Accreditation Body otherwise demonstrates one or more deficiencies in
the OTP, the Accreditation Body shall as appropriate either require and
monitor corrective action or shall suspend or revoke accreditation of
the OTP, as appropriate based on the significance of the
deficiencies.'' The proposed rule retained language about noncompliance
with one or more standards as it refined expectations for Accrediting
Bodies' follow up with these programs. Based on comments, this final
rule clarifies the intent of this subpart and survey and accreditation
requirements, while also explicitly clarifying that non-critical
findings would not result in only a one-year accreditation.
Implementation Schedule Not To Exceed 60 Days
One comment drew attention to the 33% reduction in time this
proposed change allows for submitting an implementation schedule,
pursuant to Section 8.4. The commenter believes this would introduce
significant new barriers to the delivery of care to persons with OUD
while doing nothing to improve the standard of care. Other commenters
agreed that 60 days is an insufficient amount of time to adequately
address recommendations in a manner that improves patient care.
Response: SAMHSA thanks commenters for this information. Based on
the comments, the time frames allotted for noncompliant OTPs to
implement corrections in section 8.4 were extended to 180 days. This
recognizes that some corrective measures may take more than 60 days to
successfully implement.
Surveyor Subjectivity and Need for Flexibility
In reference to Section 8.4, several commenters mentioned that
accreditation surveys are affected by the subjective interpretations of
individual auditors, and that this subjectivity contributes to their
objection to one recommendation being a preclusion for a three-year
accreditation. Some OTP guidelines may no longer be consistent with
newly proposed rules and are inconsistent with current evidence-based
practices. Further, several commenters urged flexibility in
accreditation decisions as the unique situations of many OTPs prevents
constant, exact compliance. In other words, commenters urged
flexibility in decision making based on center needs and circumstances
as well as the seriousness of the recommendation(s) and its effect on
patient care and safety.
Response: SAMHSA reviews the policies and procedures of all
Accreditation Bodies, including those related to the training and
supervision of surveyors. SAMHSA meets regularly with the Accrediting
Bodies to assure consistency in the application and interpretation of
42 CFR part 8. It also reviews the performance of Accreditation Bodies
by inspecting a selected sample of the OTPs accredited by the
respective Body each year, and, under section 8.4 will receive reports
of OTP surveys when deficiencies are discovered. Together, these help
to ensure consistency across and within Accreditation Bodies. Following
finalization of this rule, SAMHSA intends to update the 2015 Federal
Guidelines for OTPs \70\ to assure the OTP guidelines are consistent
with newly proposed rules and with current evidence-based practices.
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\70\ See <a href="https://store.samhsa.gov/sites/default/files/d7/priv/pep15-fedguideotp.pdf">https://store.samhsa.gov/sites/default/files/d7/priv/pep15-fedguideotp.pdf</a>.
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Cost Burden
Commenters reported concern that proposed changes to accreditation,
in Section 8.4, will result in more frequent inspections, which will
require significant time and financial expenditures. Commenters
expressed their conviction that the increased frequency of inspections
will take providers away from patient care and direct the focus of both
providers and administrators away from patient needs. Furthermore,
inspections have financial costs for OTPs; some commenters asserted
that the cost to some OTPs of more frequent surveys might be more than
the OTP can financially bear. Many commenters fear that the additional
administrative and financial costs will lead to fewer OTPs and thus
reduced options for patients in dire need of treatment.
Response: SAMHSA has made changes to Section 8.4 of this final rule
to respond to commenter concerns about potentially increased rates of
one-year accreditation results. In the final rule, Section 8.4(b) has
been altered to not only clarify the criteria for one-year or three-
year accreditation, but to also

[[Page 7536]]

remove potential misunderstanding around whether a specific number of
recommendations might lead to less than three-year accreditations.
Rather than implement a specific number of recommendations that might
lead to less than three-year accreditation, the final rule determines
the length of accreditation based on the severity of the non-
compliance. With this clarification in the final rule, rates of one
year accreditation and repeat surveys are not expected to increase.
Comments on Treatment Standards
MOUD Treatment Criteria Changes
Commenters overwhelmingly conveyed support for discontinuing
requirements for a one-year history of OUD to access treatment as well
as support for those changes that update admission criteria for minors.
Some commenters also suggested that SAMHSA should remove the
requirement that individuals cannot initiate methadone treatment more
than twice a year.
Response: The final rule removes the requirement, previously at
8.12(e)(2), that minors are required to have had two documented
unsuccessful attempts at short-term ``detoxification'', or withdrawal
management, or drug-free treatment within a 12-month period to be
eligible for maintenance treatment, and that those seeking withdrawal
management, previously under 8.12(e)(4), cannot initiate methadone
treatment more than twice per year. Instead, OTPs shall ensure that
patients are admitted to treatment by qualified personnel who have
determined, using accepted medical criteria, that: the person meets
diagnostic criteria for a moderate to severe OUD; the individual has an
active moderate to severe OUD, or OUD in remission, or is at high risk
for recurrence or overdose. There is nothing stated within the Federal
regulations or statutes that limits the number of times a person can
initiate treatment with methadone or any other medication.
Interim Treatment
Comments supported extending interim treatment from 120 days to at
least 180. Commenters request the availability of interim maintenance
treatment through all OTPs and not just public and private not-for-
profit OTPs, pursuant to 8.12(j)(1). Some commentors suggested interim
treatment provision in primary care providers' offices.
Response: Interim treatment was developed to expand access to OTP
services in urgent circumstances. The proposed rule specifically
amended the duration of interim treatment from 120 days to 180 days so
that on a temporary basis, a patient may receive services from an OTP,
while awaiting access to more comprehensive treatment services.
Language pertaining to public and not-for-profit OTPs has been removed
from the final rule in order to expand access to interim treatment
among all OTPs. This is done in recognition of a need to bring
individuals into treatment and in response to public comment.
Expanding the Definition of Long-Term Care Facilities
There is widespread support among commenters for the addition of
jails and prisons under the definition of long-term care facilities at
8.11(h)(3), thus expanding the waiver of OTP certification to better
allow for equitable access to treatment and reduce the potential for
civil rights violations. Group homes and withdrawal management programs
are also mentioned by some commenters in this context, as well as any
licensed non-hospital residential treatment programs with medical
staffing, a DEA registration and the ability to administer/store/
dispense prescription medications. Several commenters also requested
the removal of waiver language that specifies the OUD diagnosis be
secondary to another condition.
Response: Language has been added to the final rule, at Section
8.11(h)(3), to highlight that these flexibilities may apply to a
correctional facility that has registered with the DEA as a hospital/
clinic. If a correctional facility has registered as a hospital/clinic,
a physician or authorized staff may administer or dispense narcotic
drugs to maintain or manage withdrawal for an inmate as an incidental
adjunct to medical or surgical treatment of conditions other than
addiction. Rules regarding controlled substance dispensing that is
outside the context of OTPs, such as waiver language that specifies the
OUD diagnosis be secondary to another condition, is beyond the scope of
this rulemaking. SAMHSA notes that the Centers for Medicare & Medicaid
Services released new guidance encouraging States to apply for a new
Medicaid re-entry Section 1115 waiver demonstration project for those
persons leaving jails and prisons that this final rule may help
facilitate.\71\
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\71\ See <a href="https://www.cms.gov/newsroom/press-releases/hhs-releases-new-guidance-encourage-states-apply-new-medicaid-reentry-section-1115-demonstration">https://www.cms.gov/newsroom/press-releases/hhs-releases-new-guidance-encourage-states-apply-new-medicaid-reentry-section-1115-demonstration</a>.
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Expanding Methods of Access via OTPs and Their Mobile Units
Commenters support easing pathways, under section 8.11, for opening
new OTPs by enacting changes to ease or eliminate barriers, such as
extending certification periods, providing funding opportunities, or
encouraging existing syringe service programs to grow into new OTPs.
Commenters also support expanding geographical access at current OTPs
by easing regulations on their mobile units. They remarked on
transportation challenges for people with OUD and that having access to
mobile units will assist those who otherwise might not be able to
attend a clinic in a fixed location.
Response: Recognizing the many pathways to expanding access, the
final rule makes permanent flexibilities implemented during the COVID-
19 PHE and updates the overall regulations to reflect ways in which the
accreditation and treatment environment has evolved since part 8 went
into effect in 2001. Proposed changes that facilitate delivery of
comprehensive services in mobile units, such as the use of telehealth,
have been made permanent as they reduce barriers to receiving care,
among other goals. Regulations regarding mobile units were eased by the
DEA and SAMHSA, and use of funds allocated to States under the Block
Grant were approved for use in the purchase of mobile units.\72\ Some
commenters reference State-specific regulations that limit mobile
units, but Federal OTP regulations do not preempt separate State
requirements. SAMHSA fully encourages and facilitates additional OTP
applications.\73\
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\72\ See <a href="https://www.samhsa.gov/sites/default/files/2021-letter-state-authorities-mobile.pdf">https://www.samhsa.gov/sites/default/files/2021-letter-state-authorities-mobile.pdf</a>.
\73\ See <a href="https://www.samhsa.gov/medications-substance-use-disorders/become-accredited-opioid-treatment-program">https://www.samhsa.gov/medications-substance-use-disorders/become-accredited-opioid-treatment-program</a>.
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Expanding Methods of Access via Office and Community Settings
Many commenters emphasized that methadone treatment must be allowed
outside of OTPs, such as in office-based settings or dispensing in
community pharmacies, as many communities do not have access to OTPs.
Commenters asserted that this approach has been successfully
implemented in other countries and SAMHSA must work with the DEA to
move in this direction. Furthermore, this may help to address stigma
associated with and criticism of some OTPs and will help promote the
cultural view of OUD as a chronic disease that necessitates respectful
patient-centered care.

[[Page 7537]]

Response: The final 42 CFR part 8 rule only applies to dispensing
of methadone in OTPs. SAMHSA continues to work with Federal partners to
explore ways through which access to MOUD might be expanded.
Expanding the Definition of a Practitioner
There was strong support from commenters regarding expanding the
definition of providers, under Section 8.2, who are able to prescribe
or order medications. Commenters expressed that allowing licensed
practitioners, such as physician assistants, nurse practitioners, and
certified nurse midwives, will result in improved access to patients,
especially in areas with a high level of provider shortages. There was
further support to add pharmacists to the definition of qualified
providers. Commenters felt that including pharmacists as qualified
providers will further improve accessibility for people suffering with
OUD.
Response: Pursuant to the supplemental notice of proposed
rulemaking entitled `Medications for the Treatment of Opioid Use
Disorder: Removal of the DATA-2000 Waiver Requirements' (88 FR 9221)
requirements for staff credentials are finalized to include the
definition of a practitioner as ``a health care professional who is
appropriately licensed by a State to prescribe and/or dispense
medications for opioid use disorders and, as a result, is authorized to
practice within an OTP''. The scope of 42 CFR part 8 is also limited to
activities within an OTP.
One commenter requested clarification on the context of certified
nurse-midwives (CNMs) practice with MOUD. Another commenter requested
clarification on scope of practice for physician assistants and nurse
practitioners prescribing methadone, as there appear to be more
restrictions compared to buprenorphine.
Response: As noted above, the definition of a practitioner was
modified. However, not all States allow CNMs, nurse practitioners,
physician assistants, or pharmacists to order methadone unless
supervised by a physician. Notwithstanding additional flexibilities
provided in this final rule, practitioners must continue to adhere to
State requirements that may apply to the provision of methadone and
scope of practice. As also noted, this final rule does not apply to the
prescribing of methadone for OUD outside of OTPs.
Food and Drug Administration (FDA) Approval of Testing Supplies
Some commenters requested the removal of the proposed change
requiring drug testing services be FDA approved, under Section
8.12(f)(6), as this would impede their ability to test for fentanyl
with an instant testing method. Another commenter requested more
clarity, stating that this rule could preclude what they view as
medically necessary definitive testing at qualified laboratories,
despite the lack of an FDA review pathway for such testing. As the drug
supply continues to rapidly evolve, OTP medical directors need the
flexibility to use the best available tests, regardless of FDA
approval, to provide effective patient care.
Response: SAMHSA has amended Section 8.12(f)(6) to specifically
allow for distribution of testing strips for drug checking, to those
patients who wish to test their supply for adulteration, where not
prohibited by law. The final rule also clarifies that FDA approved
tests be used when conducting random drug testing with patients,
including urine or saliva samples, at the OTP.
Support for Provision of Resources With Patient-Centered Care Plans
Commenters were supportive of Section 8.12(5)(i) that requires OTPs
to work with patients to provide additional services such as counseling
and harm reduction (including education, testing, and treatment for
HIV, viral hepatitis, and sexually transmitted infections (STIs) when
helpful), but some commenters cautioned requiring provision of these
services without establishing their funding and requested in the
meantime that the language be amended to include assessment and
referral. Additionally, comments overwhelmingly conveyed support for
clarifying that attending counseling is not a condition of MOUD
treatment, and that treatment plans should be patient centered.
Response: Part 8 defines what is expected in the provision of
methadone for the treatment of OUD. Although it is expected that OTPs
plan for their fiscal viability to assure continuity of medication and
other treatment services, funding and sustainability are beyond the
scope of these regulations.
OTPs are expected to offer adequate medical, counseling,
vocational, educational, and other assessment, and treatment services
either onsite or by referral to an outside agency or practitioner. The
revisions in this final rule promote a patient-centered approach to
care that does not make medication continuity contingent upon
involvement in counseling services but fosters greater shared decision-
making. The revisions also relaxed the requirement that an OTP have a
formal documented agreement with outside agencies; under Section
8.12(f)(1) the final rule calls for a ``documented agreement'' to
provide such services.\74\
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\74\ See <a href="https://www.samhsa.gov/sites/default/files/dear-colleague-letter-fda-samhsa.pdf">https://www.samhsa.gov/sites/default/files/dear-colleague-letter-fda-samhsa.pdf</a>.
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Further Consideration of Tribal Communities
Some commenters advocate for increased Tribal sovereignty by
including Indian Tribes as potential Accreditation Bodies.
Additionally, while the Indian Health Service is included in the list
of exceptions for State law compliance, OTPs operated by Indian Tribes
must also be included to align with Tribal sovereignty. Accordingly,
when States or ``State law'' is referenced, they urge SAMHSA to also
include Tribes or ``Tribal law''.
Another commenter communicates concern about lack of safe
transportation and funding to access treatment on some Tribal
reservations, institutionalized racism and marginalization, as well as
lack of positive integration of American Indian/Alaska Native culture
into treatment for those populations. The commenter indicates that it
is vital that SAMHSA alter the rule to explicitly include addressing
the needs of marginalized communities, including Tribes and Tribal
entities.
Response: SAMHSA recognizes the need for culturally supportive care
that addresses race, ethnicity, Tribal sovereignty, sexual orientation,
religion and 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 in the NPRM was finalized in this rule to
ensure that the care provided is consistent with the patient's needs,
and self-identified goals for treatment and recovery. SAMHSA encourages
OTPs serving American Indians and Alaska Natives to implement
culturally competent and patient-centered care. SAMHSA notes that it
and other agencies have developed resources that

[[Page 7538]]

may be helpful in developing culturally sensitive approaches for AI/AN
populations.\75\
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\75\ See <a href="https://www.samhsa.gov/behavioral-health-equity/ai-an">https://www.samhsa.gov/behavioral-health-equity/ai-an</a>.
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The Department has not included `Tribal law' whenever `State law'
is referenced, as Tribal laws vary widely. Accordingly, understanding
what the reference means, or its scope, in some situations may be
ambiguous. Therefore, it would be inappropriate to include Tribal law
in this context.
Intake
Commenters requested clarification on the application of the new
intake rules under Section 8.12(f)(2). Some commenters requested that
clarification include explicit descriptions of rule application to
clinical scenarios such as care transitions from hospital or non-OTP
settings to OTPs. Commenters were supportive of allowing non-OTP
clinicians to complete the intake screening and full examinations to
expedite access during this process, though some commentors specified
that the OTP provider must later review and approve the exams completed
outside of an OTP. Some commentors stated that more frequent regular
medical exams may be helpful during the first year of treatment to
ensure safety and efficacy of treatment. One commenter requested
clarification as to whether the full physical exam includes a mental
status exam or an assessment of psychiatric symptoms, due to the high
incidence of such symptoms among these patients. Another commenter
requested clarity as to whether methadone may be initiated during the
14-day grace period for full OTP intake and screening/full examination,
as some State regulations interpret this differently.
Response: The final regulations, under Section 8.12(f)(2)(a),
facilitate initial screening to allow for medication to commence at
time of initial intake; SAMHSA recommends methadone medication
induction not be delayed until the full examination is completed.\76\
The purpose of the initial screening is to ensure that there are no
contraindications to prescribing methadone; this may require a
psychiatric screening or evaluation of psychiatric symptoms, if
clinically indicated. If mental health is not assessed at the time of
screening, it should be completed subsequently as part of the patient's
assessment to identify any service needs. Proposed regulations were
finalized as written, since they explicitly address these comments.
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\76\ 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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Commenters were concerned about the requirement to complete a
psychosocial assessment within 14 days, stating that patients often
experience instability at the time of entry into treatment, which makes
this difficult; some commenters suggest providing 30 days to complete
the assessment. One commenter also requested an exception be provided
to ensure patients diagnosed with OUD are not excluded from MOUD
because of documented failure or that only documentation of reasonable
effort to complete this assessment is required. Another commenter adds
that this short, prescriptive timeframe is not always conducive to
developing therapeutic rapport between patients and providers and may
force programs to be overly restrictive, disrupting patient engagement
at a critical time.
Response: Patients entering treatment for OUD are often in crisis
and this is the basis for the requirement that a complete psychosocial
assessment be conducted within 14 days. This is especially important
because the final rule allows patients new to treatment to receive up
to 7 take-home doses of methadone. The psychosocial assessment informs
part of the initial examination, and as such, it is the basis of
continued assessment and management as indicated. There is no
requirement for a definitive list of diagnoses to be created at this
time. Rather, this is an opportunity to create a detailed plan of care
which might include continued assessment and monitoring of psychosocial
status. To facilitate timely completion of the assessment, the final
rule includes flexibilities for the use of telehealth.
Serology Testing
For serology testing, comments recommend the patient should
explicitly retain the right to refuse or defer testing unless the
medical provider deems it necessary for patient safety. Others asked
for clarification on the deadline (14-day or 30-day) stating that 8.12
(f)(2)(B)(iii) and (iv) as proposed appeared contradictory.
Response: An individual patient always has the right to refuse
testing, and this provision therefore has been clarified in the final
rule. Specifically at 8.12(f)(2)(i)(b), now states that a ``patient's
refusal to undergo lab testing should not preclude them from access to
treatment, provided such refusal does not have the potential to
negatively impact treatment with medications''. In regard to the
suggested 14-day or 30-day discrepancy, these timeframes refer to use
of serology results: it is permissible to use serology results drawn no
more than 30 days prior to admission to the OTP, or up to 14 days after
admission to the OTP to complete the full examination. Thus, these two
provisions are not inconsistent.
Treatment Discharge Concerns
Several comments expressed concern over removal of language in the
proposed rule concerning discharge, asserting that this change removes
important patient protections that have helped to promote humane
discharge processes. Whether patients are discharged for nonpayment or
other reasons, commenters emphasize that tapering schedules must be
based on clinical and safety considerations.
Response: The importance of discharge planning has been highlighted
in the final rule. Specifically, under Section 8.11(f)(2)(iv) discharge
decisions have been enumerated to require a patient-centered approach.
Such decisions must be documented, and planned in a manner that
ensures, to the greatest extent possible, that patient treatment is not
disrupted. Proposed language from the NPRM pertaining to discharge
planning throughout Section 8.12 has been finalized.
Split Dosing
Numerous commenters support the expansion of split dosing for all
OTP patients receiving take-home doses, defined in Section 8.2, based
on the clinical judgement of the OTP practitioner, and urge SAMHSA to
add language specifying that additional testing and submission of
documentation for split dosing is unnecessary if the clinician has
clearly documented in the medical record that split dosing will benefit
the patient. Commenters also emphasize that take-home doses are
essential for split dosing, especially for pregnant patients and
patients driving long distances to receive medication.
Response: The final rule does not specify requirements of any
additional testing or documentation beyond that of routine clinical
practice. There is nothing in the final rule that precludes provision
of split doses for take-home doses of methadone.
Dosage During Treatment Induction
At Section 8.12(h)(3)(ii) commenters emphasize that higher initial
and next day doses are often clinically appropriate and necessary to
prevent withdrawal and treatment attrition,

[[Page 7539]]

especially for patients exposed to fentanyl, as well as for patients in
the later stages of pregnancy, and that clinicians require more
clarification on this. Commenters questioned whether the additional
medication is administered as one higher dose or additional,
incremental dose(s) at several hour interval(s). They worry that lack
of clarity will result in underutilization and thus lower treatment
retention. Some commenters suggest eliminating induction dosing
guidelines (which they view as a reflection of longstanding stigma and
discrimination against patients in OTP treatment). These commenters
suggest entrusting these decisions to practitioners, noting that other
medication dosage decisions for many medical conditions are left to
judgment and discretion of medical providers. Some commenters also
caution that higher induction doses must not be discouraged when
medically necessary for efficacious treatment.
Response: A primary purpose of the final rule is to promote use of
clinical judgement as well as patient-centered care. These comments
speak to the need for ``shared decision-making'' in the practitioner-
patient relationship, and the final rule supports this through
empowering practitioners to work with patients to create individualized
plans of care. Section 8.12(h)(3)(ii) has been clarified in a manner
that does not prohibit higher induction doses, but requires the
rationale for higher induction doses to be documented in the patient's
record.
Audio-Only Telehealth
Commenters emphasize that audio-only telehealth is an important
permanent provision for counseling and buprenorphine initiation to
ensure more equitable access to OTPs.
Response: SAMHSA agrees with commenters that telehealth, including
audio-only telehealth, can be an important tool to enhance access to
treatment. SAMHSA also recognizes scientific evidence that further
supports integration of telehealth provisions in the final rule
consistent with clinical guidelines and safety requirements. The final
rule accordingly states that in evaluating patients for treatment with
schedule III medications (such as Buprenorphine) or medications not
classified as a controlled medication (such as Naltrexone), audio-
visual or audio only platforms may be used at the patient and
provider's preference. For schedule II medications (such as Methadone),
the rule allows for audio-visual telehealth initiation by the OTP
practitioner. When audio-visual technologies are not available or their
use is not feasible for a patient, it is acceptable to use audio-only
devices, but only when the patient is in the presence of a licensed
practitioner who is registered to prescribe (including dispense)
controlled medications. This is because, as noted, in the proposed
rule, schedule II medications such as methadone pose increased risk
compared to schedule III medications such as buprenorphine. In all
cases, medications for the treatment of OUD shall be ordered by the OTP
practitioner.
Audio/Visual Telehealth for Medical Intake and ``Annual Physical''
Appointments
Video-based telehealth, under section 8.12(f)(2)(B)(v), is
overwhelmingly supported by commenters for medical intake, periodic
medical assessments, and methadone or buprenorphine initiation by OTP
practitioners. Onsite staff can supplement telehealth care by gathering
vital sign and toxicology data, when necessary. One comment questioned
if any appropriate limits, for example on the number of patients a
single physician could oversee via telehealth should be added.
Response: SAMHSA appreciates these comments and has finalized
proposed changes in the final rule. Requirements pertaining to
telehealth, including the number of patients that a practitioner may
see, are governed by applicable State and Federal laws. As noted above,
however, provisions in this final rule support use of telehealth as
part of patient treatment.
Take-Home or Unsupervised Doses
Provisions expanding take-home or unsupervised methadone medication
doses, under Section 8.12(i), are mostly supported, with commenters
citing increased patient autonomy and pride, improved outcomes and
treatment retention, and reduced barriers to treatment. The removal of
the eight take-home criteria is accordingly supported by some, though
others note that toxicology testing is important to help maintain
public and patient safety. Some commenters expressed concern about
potentially increased diversion, while another commented that diversion
is a sign of unmet community need and should be addressed as such,
rather than criminalized. Some commenters worried that the revised
take-home allowances are too flexible and some proposed different
guidelines; others supported them or even wanted them eliminated
entirely, trusting providers with that responsibility. Yet, other
commenters worried that leaving decisions about take-homes completely
to the discretion of providers could result in provider abuse and
suggested that some parameters are necessary.
Many commenters expressed frustration that not all patients receive
equitable access to take-homes, whether for insurance reasons or lack
of clinic/state implementation. Some commenters suggest the addition of
take-home metrics during the OTP survey process to help address this.
Another commenter suggested SAMHSA provide a method of recourse for
patients dissatisfied with decisions made about their take-home
eligibility. One commenter requested clarification on insurance
coverage of take-home doses, specifically with Medicare or Medicare
Part D. One commenter asked that SAMHSA end the requirement for
requested program exceptions when closing or dispensing extra take-home
doses for weather emergencies and state holidays, and that patient
suitability documentation for days the clinic is closed is only
required for patients denied take-home medication.
Response: SAMHSA recognizes that its proposed provisions concerning
take-homes were significant. Proposed changes have been finalized
without alteration. While this approach promotes practitioner
discretion, determining risk factors and preventing diversion has
required team input since the original regulations were promulgated
over 20 years ago.
A standard for treatment that is common to all Accreditation Bodies
is that OTPs have policies regarding patient complaints and procedures
that protect patients from retaliation. SAMHSA requires that
Accreditation Bodies have policies and procedures in place to respond
to complaints received from the Secretary, patients, facility staff,
and others. Therefore, patients who have complaints about take-homes
shall have access to recourse through required patient complaint and
grievance procedures.
Determinations about insurance coverage and reimbursement for MOUD,
while important, are outside the scope of this rulemaking.
Need for More Data
Several commenters expressed an ongoing need for more data to
ensure treatment changes (such as additional take-home medication
doses, induction dosing schedules, expansion of the definition of a
qualified provider) are safe, especially post COVID-19 public health
emergency (PHE) as circumstances and environments change. Some had
concerns that changes provided too much flexibility,

[[Page 7540]]

especially with respect to take-home doses during the first week(s) of
treatment, due to less patient stability/functionality during this
transitional period. Others mentioned that patients might handle
medications differently outside of the COVID-19 PHE environment, due to
lack of behavior-modifying factors present during the PHE, such as
isolation and fear for continued treatment. Other commenters expressed
the need for more data related to induction dosing and best practices
for rapid induction to effective doses while minimizing risk.
Response: Data is important to performance monitoring and
evaluations of health care interventions. Accreditation standards
require that OTPs have quality assurance systems that consider patient
outcomes. The data related recommendations noted in these comments are
items that could be incorporated into the OTPs quality assurance
processes. These recommendations are better addressed in the revision
of the Federal OTP guidelines that SAMHSA will complete following this
rulemaking. SAMHSA and its partners, including the Centers for Disease
Control and Prevention, FDA and National Institutes of Health (NIH),
support further research on these issues, and SAMHSA will monitor the
impact of this rule. As one example, FDA, SAMHSA and the Reagan-Udall
Foundation held a meeting in May 2023 regarding `Considerations for
Buprenorphine Initiation and Maintenance Care' to ``explore real-world
experiences and scientific evidence for buprenorphine initiation
strategies as well as medication dosing and management during continued
treatment across different care settings.'' \77\ SAMHSA and NIH
similarly collaborate to support the Helping to End Addiction Long-
term[supreg] Initiative which focuses on improving pain treatment and
developing community-level solutions to opioid addiction.\78\ SAMHSA
will continue on its own and with other agencies and stakeholders to
explore and support research on these issues.
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\77\ See <a href="https://reaganudall.org/news-and-events/events/considerations-buprenorphine-initiation-and-maintenance-care">https://reaganudall.org/news-and-events/events/considerations-buprenorphine-initiation-and-maintenance-care</a>.
\78\ See <a href="https://heal.nih.gov/">https://heal.nih.gov/</a>.
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Pregnancy Testing
Several commenters advised against requiring pregnancy testing,
under Section 8.12(f)(B)(iii), for pregnant OTP patients. They reasoned
that, in a time when States are increasingly restricting and even
criminalizing reproductive options, pregnancy testing may dissuade
patients of child-bearing potential from seeking treatment.
Response: Pregnancy testing is often necessary for appropriate
clinical care, and the final rule clarifies that pregnancy testing
should be requested only when clinically appropriate, and that refusal
of such testing should not preclude access to treatment. Safeguarding
patient privacy and health is essential, and in all cases, providers
must adhere to State and Federal laws and regulations, clinical
requirements and professional guidelines when considering screening and
disclosure of testing results. For instance, the 2015 `American College
of Obstetricians and Gynecologists policy on Alcohol Abuse and Other
Substance Use Disorders: Ethical Issues in Obstetric and Gynecologic
Practice', emphasizes the importance of patient informed consent for
testing.\79\
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\79\ See <a href="https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2015/06/alcohol-abuse-and-other-substance-use-disorders-ethical-issues-in-obstetric-and-gynecologic-practice">https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2015/06/alcohol-abuse-and-other-substance-use-disorders-ethical-issues-in-obstetric-and-gynecologic-practice</a>.
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Ramifications of Dependency Diagnosis
One commenter expressed concern that under Section 8.12(f)(2), all
patients receiving opioids must be documented in the medical chart with
an opioid dependence diagnosis, even if the patient is a pain patient
and the doctor has no dependency concerns. One commenter is concerned
that this could affect eligibility for future organ transplants.
Response: These regulations establish the procedures by which the
Secretary of HHS determines whether a program is qualified to dispense
methadone and other medications in the treatment of opioid use
disorders and standards regarding the use of these medications for
treatment purposes, in accordance with the Controlled Substances Act
(CSA) under 21 U.S.C. 823(h). As a result, a diagnosis of opioid use
disorder is required. SAMHSA notes that opioid dependence is an older
diagnostic term that, in the U.S., has been replaced with the
diagnostic term of opioid use disorder and associated diagnostic
criteria. Proposed changes, as written, were finalized in the rule.
Protecting Patient Data
Central registries are often queried to detect and prevent
potential multiple enrollments in more than one OTP. Central registries
are briefly described in 42 CFR part 2 (Confidentiality of Substance
Use Disorder Patient Records) regulations, but one commenter is
concerned that there do not appear to be limits on their collection and
sharing of sensitive patient information and requests regulations
better clarify appropriate practices.
Response: Central registries are State-based operations. Although
the patient information is protected, procedures for assuring
protection and relevant regulations such as 42 CFR part 2 and the
Health Insurance Portability and Accountability Act are outside the
scope of these Part 8 regulations.
Alignment of State and Federal Guidelines
There were many commenters that expressed concerns with State
regulations as they intersect with proposed SAMHSA changes. If States
have more restrictive regulations, especially related to medication
administration, for instance, then patients in those States may not
benefit from Federal changes, some commenters asserted. These
commenters urged that States be required to align with Federal
regulations, even if it means withholding funds to States who refuse to
adopt new Federal regulations. Some commentors also requested language
be added mandating State Opioid Treatment Authorities (SOTAs) are
included in communications such as when and how an OTP is not meeting
standards, withdrawal of approval of Accreditation Bodies, and others.
Response: These rules do not mandate that States promulgate less
restrictive rules to match provisions of Federal law that may provide
more flexibility. SAMHSA works closely and collaboratively with the
SOTAs and State mental health and substance use disorder treatment
authorities, the Accreditation Bodies, as well as other Federal
agencies to encourage State and Federal alignment and information-
sharing.
Other Themes
There were two comments that urged keeping Levomethadyl acetate
(LAAM) on the list of approved treatment medications. These comments
suggested that research could indicate it is an effective treatment for
opioid use disorder and that it may soon be available for use again.
Additionally, other comments advocated integration of other FDA-cleared
treatment options like neuromodulation and other medical technology.
Response: Currently, LAAM is not available in the United States.
For this reason, it was removed from the list of currently approved and
available medications for OUD. The list provided in the rule is
current, and there is nothing that precludes changes to the list of
medications used to treat OUD in the future. Technology is not
currently

[[Page 7541]]

addressed in 42 CFR part 8 as devices and available applications are an
adjunct to treatment with MOUD. SAMHSA will monitor the development and
approval of new medical devices by FDA for the treatment of chronic
opioid use disorder and will consider updates to part 8 as needed.

E. Summary of the Final Rule

The Department has finalized the following changes to 42 CFR part 8
that revise, delete, replace, or add sections. This section summarizes
changes in the final rule, and discusses changes made after review of
public comments on the NPRM entitled `Medications for the Treatment of
Opioid Use Disorder' (87 FR 77330), and the SNPRM entitled `Medications
for the Treatment of Opioid Use Disorder: Removal of the DATA-2000
Waiver Requirements' (88 FR 9221).
1. Title
The Department has finalized the title, originally proposed in the
NPRM, as being: Medications for the Treatment of Opioid Use Disorder.
As discussed in the NPRM, this title reflects current medical
terminology and removes 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.\80\ The amended
title reflects current medical terminology and highlights that OUD is a
chronic, treatable condition.
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\80\ 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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2. Subpart A
Reorganization of subpart A, as proposed in the NPRM and SNPRM, has
been finalized and includes the scope and definitions.
3. Section 8.1--Scope
Pursuant to the NPRM and SNPRM, Sec. 8.1 is finalized to reflect
modern medical terminology, to detail updated acronyms, and for
clarity. Of note, the term medication assisted treatment (MAT) has been
updated to medications for opioid use disorder (MOUD), and the term
treatment program has been changed to opioid treatment program
throughout the final rule. Pursuant to proposed changes set forth in
the SNPRM entitled `Medications for the Treatment of Opioid Use
Disorder: Removal of the DATA-2000 Waiver Requirements' (88 FR 9221),
reference to subpart F has been removed.
4. Section 8.2--Definitions
Changes proposed by the NPRM and SNPRM have been finalized in Sec.
8.2 to add, remove 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. Definitions for additional credentialing, approval term,
covered medications, and emergency situation have been removed.
5. Section 8.3--Application for Approval as an Accreditation Body
Changes proposed by the NPRM are finalized to include 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. Furthermore,
this regulation is updated, pursuant to the NPRM, to ensure that
Accreditation Bodies provide training policies specifically related to
training of survey team members. As described in the NPRM, the final
rule also provides for Indian Tribes, in addition to State or
territorial governments, to apply for approval as an Accreditation
Body.
6. Section 8.4--Accreditation Body Responsibilities
In response to public comments, language that clarifies SAMHSA's
oversight of Accreditation Bodies, and associated expectations, has
been updated and finalized. To this end, the Department has provided
clarification on the 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. In particular, section 8.4(b)
of the final rule includes: provisions requiring categorization of the
types of non-compliance; provisions that differentiate between
accreditation duration based on the severity of non-compliance; and
adds provisions detailing procedures for severe non-compliance. Time
frames for submission of survey reports are also finalized. Pursuant to
the NPRM, the Department has finalized the 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, as per the NPRM, the final rule adds a
requirement that Accreditation Bodies notify SAMHSA of all aspects of a
complaint response within 5 days of receipt. Similarly, the previous
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 finalized, pursuant to the NPRM, to update
categories of certification, to clarify the requirement that OTPs
maintain certification, and to establish procedures for OTPs whose
certification has lapsed. Terms for the extension of certification are
finalized, as are the means of requesting an extension. The final 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.
As described in the NPRM, the final rule removes ``Transitional
certification'' which expired as a category of certification in 2003.
Further, 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.
Pursuant to the NPRM, the conditions for approval of interim
treatment have been finalized to increase the duration of interim
treatment from 120 days to 180 days, with the stipulation that

[[Page 7542]]

individuals shall not be discharged without the approval of an OTP
practitioner while awaiting transfer to a comprehensive treatment
program. In response to public comments on the NPRM, availability of
interim treatment is also expanded to all OTPs. For clarity, reference
to section 1923 of the Public Health Service Act (21 U.S.C. 300x-23) is
removed. The NPRM and final 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.
As described in the NPRM, the services that can be provided in
medication units have been finalized 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, as described in the NPRM, are
finalized in order 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
medications, has been removed and patient-centered language is added.
The paragraph on staff credentials, found in the NPRM, is finalized
to expand the definition of a practitioner to a ``a health care
professional who is appropriately licensed by a State to prescribe and/
or dispense medications for opioid use disorders and, as a result, is
authorized to practice within an OTP.'' The expectation that all
licensed and credentialed staff maintain licensure and/or certification
has been finalized.
Criteria for admission to treatment, as discussed in the NPRM,
removes reference to the Diagnostic and Statistical Manual of Mental
Disorders (DSM) IV and eliminates the requirement for a one-year
history of OUD. Instead, the final rule 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 finalized to ensure 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 altered to the extent that 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 finalized so 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 correctional
settings, pregnant patients or previously enrolled individuals has been
removed.
Throughout the document, as described in the NPRM,
``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 paragraph on ``Required services'' is finalized to incorporate
patient-centered language, establish flexible terminology, promote use
of clinical judgment, and clarify SAMHSA's expectations of OTPs. The
final 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
finalized, pursuant to the NPRM, 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 final 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 at the OTP, by the OTP
practitioner, has also been finalized in the rule. Additionally, the
paragraph on special services for pregnant people is finalized to
specify that confirmation of pregnancy should be requested for priority
treatment admissions. The option to use split dosing for patients, as
described in the NPRM, is also finalized.
The components of initial and periodic medical examinations have
been finalized, pursuant to the NPRM, 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 finalized so as to assure information is gathered in 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 finalized, such as ``services a
patient needs and wishes to pursue''.
The final rule expands the provision of `counseling services' that
are provided by OTPs 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 finalized 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 finalized to remove the word ``formal''; the final
rule calls for a ``documented agreement'' to provide such services.
Language that addresses drug testing services has been finalized to
remove stigmatizing phrases, such as ``drug abuse'', and to remove
content on short-term withdrawal management (``detoxification'').
Further to this, the final rule clarifies that the requirement to use
drug tests that have received the Food and Drug Administration (FDA)'s
marketing authorization is limited to random drug testing using samples
obtained from patients, including urine or saliva. Pursuant to public
comments on the NPRM, the final rule does not preclude distribution of
legally permissible testing supplies, that check for adulteration of an
individual's personal drug supply.
Rules that address recordkeeping and efforts to avoid simultaneous
enrollment in multiple OTPs are finalized, as per the NPRM, 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 final 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.
As described in the NPRM, specification of disciplines authorized
to administer or dispense MOUD is removed from the final rule. LAAM,
also known as Levomethadyl acetate, is removed from the list of
treatment

[[Page 7543]]

medications because it is no longer available, and other medications
approved since prior revisions to this rule were added. In response to
public comments, the regulation of an initial dose of methadone has
been increased to 50mg on the first day, with the clarification of
allowance 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 final rule, while redundant language was removed.
Rules on the provision of unsupervised (or take-home) doses of
methadone are finalized, as per the NPRM, to incorporate flexibilities
issued in response to the COVID-19 pandemic. In general, the final
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
is finalized, as well as patient education on safe transport and
storage of take-home doses, including documentation of the provision of
this education in the patient's clinical record.
Consistent with the conditions for approval of interim treatment,
the final 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 rule finalizes
removal of the requirement for observation of all daily doses during
interim treatment. It also finalizes 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 is also finalized.
9. Section 8.13--Revocation of Accreditation and Accreditation Body
Approval
References to an OTP as a ``program'' instead of a ``facility'' are
finalized.
10. Section 8.14--Suspension or Revocation of Certification
Pursuant to the NPRM, this section finalizes the actions that
SAMHSA may take when immediate intervention is necessary to protect the
public's health or safety. The final rule specifies the administrative
actions available to SAMHSA in the event that a program sponsor, or any
employee of an OTP has: been found to have engaged in 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.
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
References to an OTP as a ``program'' instead of a ``facility'' are
finalized.
12. Subpart F--Authorization To Increase Patient Limit to 275 Patients
This subpart and corresponding sections are removed from the final
rule, as described in the SNPRM.

Severability

The Department asserts that provisions in this final rule are
severable. If any provision of this rule, or the application thereof to
any person or circumstance is held invalid, that invalidity shall not
affect other provisions or applications of this rule that can be given
effect without the invalid provision or application.
This rule has been organized in a way that separates out the major
provisions into distinct sections and subparts. Many of the provisions
in this rule are independent of each other and could function sensibly
even without certain other provisions being in effect. For example, the
provisions in subparts A, B and C related to accreditation and
certification are distinct from the Treatment Standards enumerated in
subpart C section 8.12. Rules related to take-home dosing of methadone
are also severable from other rules, such as those regarding telehealth
and interim treatment.
If any specific provision of this rule is found unconstitutional or
invalid, the Department intends that the remainder would still operate
independently. The Department believes that each provision in this rule
offers a distinct benefit to the public, patients, and healthcare
providers. Therefore, if any specific application or provision is
invalidated, the remainder of the legally valid provisions should
remain in effect.

Regulatory Impact Analysis

The Department has examined the impact of the final 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 final rule is being issued to update part 8 in response to
increasing opioid overdose deaths, exacerbated by the COVID-19
pandemic.\81\ Across the United States in 2021, 9.2 million people aged
12 or older misused heroin or misused prescription pain relievers in
the preceding twelve months.\82\ The percentage was highest among young
adults aged 26 or older (3.5 percent or 7.7 million people), followed
by adults aged 18 to 25 (3.1 percent or 1 million people). It was
lowest among adolescents aged 12 to 17 (1.9 percent

[[Page 7544]]

or 497,000 people).\83\ These numbers likely underestimate the true
prevalence of opioid misuse and opioid use disorder (OUD), since the
use of illicitly manufactured fentanyl has not to date been considered
in the National Survey on Drug Use and Health (NSDUH), 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 and not living in
shelters, are not included in the NSDUH.
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\81\ 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.
\82\ Substance Abuse and Mental Health Services Administration.
(2022). Key substance use and mental health indicators in the United
States: Results from the 2021 National Survey on Drug Use and Health
(HHS Publication No. PEP22-07-01-005, NSDUH Series H-57). Center for
Behavioral Health Statistics and Quality, Substance Abuse and Mental
Health Services Administration. <a href="https://www.samhsa.gov/data/report/2021-nsduh-annual-national-report">https://www.samhsa.gov/data/report/2021-nsduh-annual-national-report</a>.
\83\ 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="http://dx.doi.org/10.15585/mmwr.mm7129e2">http://dx.doi.org/10.15585/mmwr.mm7129e2</a>. See also <a href="https://www.seattletimes.com/nation-world/nation/addiction-treatment-medicine-is-vastly-underprescribed-especially-by-race-study-finds/">https://www.seattletimes.com/nation-world/nation/addiction-treatment-medicine-is-vastly-underprescribed-especially-by-race-study-finds/</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
non-Hispanic Black, American Indian and Alaska Native communities over
the course of the pandemic.\83\ 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.\83\ 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.\83\ It was also found that Black people were
less than half as likely as white people to have received substance use
treatment. As SAMHSA has noted, the Hispanic community also has been
adversely impacted by opioid overdoses.\84\
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\84\ Substance Abuse and Mental Health Services Administration:
The Opioid Crisis and the Hispanic-Latino 1opulatiorgent Issue.
Publication No. PEP20-05-02-002. Office of Behavioral Health Equity.
Substance Abuse and Mental Health Services Administration, 2020.
<a href="https://store.samhsa.gov/sites/default/files/pep20-05-02-002.pdf">https://store.samhsa.gov/sites/default/files/pep20-05-02-002.pdf</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 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),\85\ yet few people who may
benefit from these medications have immediate and sustained access to
them.\86\
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\85\ 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.
\86\ 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.\87\ Research
reveals that the rate of methadone treatment at that time was highest
in low-income urban areas.\88\ 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.\89\ SAMHSA believes that changes to part 8 will, as
described above, facilitate:
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\87\ 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.
\88\ 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.
\89\ 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> Reduced stigma and discrimination based on changes to
ensure updated language and terminology;
<bullet> Clarification of standards applying to Accreditation
Bodies; and
<bullet> Revising Federal Opioid Use Disorder Treatment Standards.
SAMHSA notes below that these changes are associated with limited
burden as the final rule does not substantially alter reporting or
accreditation activities. The changes 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.

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 final rule is partially regulatory and partially deregulatory.
The Department estimates that because much of what has been finalized
does not substantially alter current practice as implemented over the
past 3 years under the COVID PHE, the final rule will not result in
significantly altered costs. Further to this, the final 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 final rule makes permanent some OTP treatment
flexibilities implemented within the past three 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.\90\
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.\91\ Black youth ages 15 to
24 saw an 86 percent increase in overdose deaths, the largest spike of
any

[[Page 7545]]

age or race group, while Black men 65 and older were nearly seven times
as likely than white men to die from an overdose.\90\ 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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\90\ 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="http://dx.doi.org/10.15585/mmwr.mm7129e2">http://dx.doi.org/10.15585/mmwr.mm7129e2</a>.
\91\ Krawczyk, N., Rivera, B.D., Levin, E., & Dooling, B.C.E.
(2023). Synthesizing evidence of the effects of COVID-19 regulatory
changes on methadone treatment for opioid use disorder: implications
for policy. The Lancet. Public health, 8(3), e238-e246. <a href="https://doi.org/10.1016/S2468-2667">https://doi.org/10.1016/S2468-2667</a>(23)00023-3.
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This disparity amplifies the importance of promoting patient-
centered care that is culturally appropriate and responsive to patient
need, while also fostering a treatment environment that promotes and
sustains patient engagement. The final rule facilitates 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 final rule promotes
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 final rule also facilitates 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 three years demonstrates safety,
as well as high patient and practitioner satisfaction with take-home
doses of methadone.\91\ This is principally because take-home doses of
methadone allow individuals the opportunity to engage in employment,
education and 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.\92\ Among the 39 jurisdictions
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.\93\
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\92\ 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>. See also
<a href="https://trumpwhitehouse.archives.gov/briefings-statements/cea-report-underestimated-cost-opioid-crisis/">https://trumpwhitehouse.archives.gov/briefings-statements/cea-report-underestimated-cost-opioid-crisis/</a> citing a Council of
Economic Advisors study estimating 2015 costs at $504 billion and a
Congressional study using the CDC methodology estimating 2020 opioid
crisis costs as $1.5 trillion. See <a href="https://beyer.house.gov/news/documentsingle.aspx">https://beyer.house.gov/news/documentsingle.aspx</a>.
\93\ 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.\94\ 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%).\95\ 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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\94\ Fairley M, Humphreys K, Joyce VR, et al. (2021). Cost-
effectiveness of Treatments for Opioid Use Disorder. JAMA
Psychiatry. 2021;78(7):767-777. doi:10.1001/
jamapsychiatry.2021.0247.
\95\ McAdam-Marx C, Roland CL, Cleveland J, Oderda GM (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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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. $8,436; P
<0.001).\95\ 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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\96\ Murphy SM, 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.
\97\ Baser O, Chalk M, Fiellin DA, Gastfriend DR (2011). Cost
and utilization outcomes of opioid-dependence treatments. Am J Manag
Care. 2011 Jun;17 Suppl 8:S235-48. PMID: 21761950.
\98\ Lynch FL, McCarty D, Mertens J, Perrin NA, Green CA,
Parthasarathy S, Dickerson JF, Anderson BM, 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.
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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.96 97 98 For example,
a 2019 analysis demonstrated that a comprehensive approach to OUD
treatment is associated with improved health and economic outcomes.\99\
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$1,448 vs. $4,265, P =
0.001).\100\ 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

[[Page 7546]]

retention, fewer hospital stays, and lower costs.
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\99\ 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.
Population health management, 22(4), 292-299. <a href="https://doi.org/10.1089/pop.2018.0163">https://doi.org/10.1089/pop.2018.0163</a>.
\100\ Mohlman MK, 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.
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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.\100\ Two prior studies assessed data
from commercial health insurance claims on the overall health care
costs and utilization rates for those taking MOUD compared to those
treated without MOUD.101 102 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.\101\ The
other study found that after a six-month period, those taking MOUD had
significantly lower overall annual health plan costs compared to those
with no medication ($10,192 vs. $14,353; p-value < 0.0001).\102\ The
difference was driven largely by lower inpatient services and non-
opioid-related outpatient services for the group receiving medication.
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\101\ McCarty D, Perrin NA, Green CA, Polen MR, Leo MC, 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.
\102\ Baser O, Chalk M, Fiellin DA, Gastfriend DR. (2011). Cost
and utilization outcomes of opioid-dependence treatments. Am J Manag
Care. 2011 Jun;17 Suppl 8:S235-48. PMID: 21761950.
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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 rule does not substantially alter current reporting burden
requirements, or accreditation activities. The total number of burden
hours reported in 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.
b. Estimated Costs of Reporting Burdens for OTPs and Accreditation
Bodies
In developing its estimates of the potential costs of the final
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 394.2 $85.42 $33,672.56
42 CFR 8.4 and 8.6.............................................
Form SMA-162, compliance with other reporting requirements under 188.95 85.42 16,140.11
21 CFR 8.11, 8.24, 8.25, 8.26, and 8.28........................
Form SMA-168, Exception Request and Record of Justification 2,135 85.42 182,371.70
Under 42 CFR 8.11(h)...........................................
-----------------------------------------------
Sub total................................................... .............. .............. $232,184.37
----------------------------------------------------------------------------------------------------------------

c. Cost Pertaining to Record Keeping
The record-keeping 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 record-keeping 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 or a cost burden for these
activities, nor did commenters provide such information.

Costs Pertaining to Disclosure

The final 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.

[[Page 7547]]

e. Estimate of Annualized Non-Hourly Cost Burden to Respondents
The final 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
2,000 affected OTPs these total annual costs are estimated to be
$30,752,000. The percentage of this total cost that is associated with
record keeping 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 protected
website for day-to-day regulatory activities that can be used by
SAMSHA, opioid treatment programs, State Opioid Treatment Authorities,
Accreditation Bodies and other stakeholders. This estimate does not
include funds that SAMHSA/Center for Substance Abuse Treatment (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/CSAT
----------------------------------------------------------------------------------------------------------------
Total cost@
Item (purpose) Responses Hours per Total hours $85.42 per
response 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 15 .50 7.5 641
Certification..................................
Notification of Sponsor or Medical Director 60 0.33 19.8 1,691
Change.........................................
Documentation to SAMHSA for Interim Treatment... 1 0.50 0.5 43
Requests to SAMHSA for Exemption from Sec. Sec. 24,000 0.07 1680 143,506
8.11 and 8.12 (including SMA-168)............
Notification to SAMHSA Before Establishing 20 1.00 20 1,708
Medication Units...............................
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
---------------------------------------------------------------
Sub total................................... 25,03625,036 97.15 2592.3 221,434
----------------------------------------------------------------------------------------------------------------

2. Consideration of Regulatory Alternatives
The Department has completed 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. This is considered to be
suboptimal as it creates uncertainty among patients and OTPs, while
also constraining access to care. Rulemaking, on the other hand, allows
OTPs and their patients to operate in a stable and regulated
environment that promotes access to evidence-based interventions. Other
changes in the rule impact Accreditation Body oversight and procedures.
Such changes can only be effectuated in a regulatory setting.

B. Regulatory Flexibility Act

The Department has examined the economic implications of this final
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.
Pursuant to the RFA (5 U.S.C. 601-612), the Department asserts a
factual basis for its certification that the rule will not have a
significant economic impact on a substantial number of small entities.
As discussed in the Regulatory

[[Page 7548]]

Impact Analysis (RIA) the costs associated with compliance are minimal.
As such, the Department certifies that the proposed rule will not
impose a significant economic impact. The RIA contains the factual
details supporting this certification, affirming the conclusion that
the financial impact of compliance is insubstantial in relation to the
affected entities' financial operations.

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 2023, this threshold is $165 million. The
Department does not anticipate that this final 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 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 \103\ requires Federal departments and agencies to
determine whether a 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 final 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 rule.
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\103\ 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 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 sought public
comment on its assumptions as they relate to the PRA requirements
summarized in this section. No applicable comments were received.
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 OTPs
pursuant to the final rule.

Estimated Annual Reporting Requirement Burden for Accreditation Bodies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Total Hours/
42 CFR citation Purpose respondents respondent responses response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3(b)(1) through (11).................... Initial approval (SMA-163).. 1 1 1 6.0 6
8.3(c).................................... Renewal of approval (SMA- 2 1 2 1.0 2
163).
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 2 2 4 1.0 4
seriously noncompliant OTPs.
8.4(b)(1)(iii)............................ Notification to OTP for 2 10 20 1.0 20
serious noncompliance.
8.4(d)(1)................................. General documents and 6 5 30 0.5 15
information to SAMHSA upon
request.
8.4(d)(2)................................. Accreditation survey to 6 75 450 0.02 9
SAMHSA upon request.
8.4(d)(3)................................. List of surveys, surveyors 6 6 36 0.2 7.2
to SAMHSA 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

[[Page 7549]]

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 1 1 1 10 10.0
corrective plan to SAMHSA.
8.6(b)(1)................................. Notification to accredited 1 185 185 0.3 55.5
OTPs of Probationary Status.
-------------------------------------------------------------------------------------------------------------
Sub total............................. ............................ 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- 386 1 386 0.15 57.9
162).
8.11(b)................................... Relocation of Program (SMA- 35 1 35 1.17 40.95
162).
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 60 1 60 0.1 6.00
medical director change
(SMA-162).
8.11(h)(2)................................ Documentation to SAMHSA for 1 1 1 1 1.00
interim treatment.
8.11(i)................................... Request to SAMHSA for 1,200 20 24,000 0.07 1,680
Exemption from Sec. Sec.
8.11 and 8.12 (including
SMA-168).
8.11(j)(1)................................ Notification to SAMHSA 10 1 10 0.25 2.5
Before 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 2 1 2 0.25 .50
Request for Review of
Suspension.
8.25(a)................................... Informal Review Request..... 2 1 2 1.00 2.00
8.26(a)................................... Appellant's Review File and 2 1 2 5.00 10.00
Written Statement.
8.28(a)................................... Appellant's Request for 2 1 2 1.00 2.00
Expedited Review.
8.28(c)................................... Appellant Review File and 2 1 2 5.00 10.00
Written Statement.
-------------------------------------------------------------------------------
Sub total............................. ............................ 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 final
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 eighteen months. Further to this, the estimates
of burden do not substantially differ from previously submitted
estimates provided to The Office of Management and Budget. Recognizing
the importance of expanding access to care, the Department has been
careful to limit additional burden.
The final 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 final 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 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

[[Page 7550]]

Services revises 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]

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) Scope. 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 applicant seeking to
become an Opioid Treatment Program (OTP) is qualified under section
303(h) of the Controlled Substances Act (CSA) (21 U.S.C. 823(h)) 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(h)). 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) Severability. Any provision of this part held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, or stayed pending further agency action, shall be
construed so as to give it the maximum effect permitted by law, unless
such holding shall be one of utter invalidity or unenforceability, in
which event such provision shall be severable from this part and shall
not affect the remainder thereof or the application of the provision to
persons not similarly situated or to dissimilar circumstances.

Sec. thnsp;8.2 Definitions.

The following definitions apply to this part:
Accreditation Body or ``the 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 or virtual review and
evaluation of an OTP by an Accreditation Body for the purpose of
determining compliance with the Federal opioid use disorder 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).
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 telehealth
or 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 significant 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.
Dispense means to deliver a controlled medication to an ultimate
user by, or pursuant to, the lawful order

[[Page 7551]]

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.
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, take-home
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 and legal evidence-based
strategies, including: overdose education; testing and intervention for
infectious diseases, 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 some 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(h)(1), and the term ``withdrawal management'' is intended to be
synonymous with the term ``detoxification'' as used in 21 U.S.C.
823(h)(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(h)(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 this part, means any individual who
receives continuous treatment or withdrawal management in an OTP.
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
receiving care in OTPs achieve and sustain remission and recovery.
Practitioner, for purposes of this part, means a health care
professional who is appropriately licensed by a State to prescribe and/
or dispense medications for opioid use disorders and, as a result, is
authorized to practice within an OTP.
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.

[[Page 7552]]

(2) Recovery support services can include, but are not limited to,
community-based recovery housing, 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 take other
medications or drink 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, for purposes of this part, is the
delivery and facilitation of health and health-related services
including medical care, counseling, 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 use disorder treatment
standards set forth in Sec. 8.12;
(4) A detaile

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