[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 [www.gpo.gov]
[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  

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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: 
[email protected].

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 
https://www.govinfo.gov/content/pkg/USCODE-2016-title21/html/USCODE-2016-title21-chap13-subchapI-partC-sec823.htm.
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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 https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf and https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
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    This final rule not only makes these COVID-19-related flexibilities 
permanent, but also updates standards

[[Page 7529]]

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 https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
    \16\ See https://www.hhs.gov/about/news/2023/05/09/fact-sheet-end-of-the-covid-19-public-health-emergency.html
    \17\ See https://www.hhs.gov/overdose-prevention/. See also 
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/
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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 https://findtreatment.gov/
    \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

[[Page 7530]]

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 https://www.samhsa.gov/sites/default/files/colleague-letter-xylazine.pdf.
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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 http://wonder.cdc.gov.
    \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: https://www.ncbi.nlm.nih.gov/books/NBK232108/
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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 https://www.federalregister.gov/documents/2016/07/08/2016-16120/medication-assisted-treatment-for-opioid-use-disorders.
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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 https://dpt2.samhsa.gov/treatment/directory.aspx.
    \32\ See https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/methadone-guidance; and 
https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/buprenorphine-at-opioid-treatment-programs
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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\ https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-8?toc=1.
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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. https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf.
    \35\ See https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf.
    \36\ See https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
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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. https://doi.org/10.1016/S2468-2667(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 https://irp.drugabuse.gov/wp-content/uploads/2019/12/NIDA-Medications-to-treat-opioid-use-disorder_2018.pdf.
    \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, https://doi.org/10.1016/j.jsat.2021.108276.
    \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. https://regulatorystudies.columbian.gwu.edu/unsupervised-use-opioid-treatment-medications.
    \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. https://doi.org/10.1001/jamapsychiatry.2022.1776.

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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 https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/methadone-guidance
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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. https://www.ama-assn.org/system/files/2020-04/ama-telehealthimplementation-playbook.pdf
    \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), https://www.deadiversion.usdoj.gov/GDP/(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), https://www.deadiversion.usdoj.gov/GDP/(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 https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
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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. https://doi.org/10.1007/s11606-021-06969-1.
    \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. 
https://doi.org/10.1001/jamanetworkopen.2022.51856

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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: https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/buprenorphine-at-opioid-treatment-programs
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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 https://www.federalregister.gov/documents/2021/06/28/2021-13519/registration-requirements-for-narcotic-treatment-programs-with-mobile-components.
    \65\ See https://www.samhsa.gov/medication-assisted-treatment/statutes-regulations-guidelines#mobile.
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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 https://www.samhsa.gov/newsroom/press-announcements/202104070200
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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 https://www.samhsa.gov/sites/default/files/samhsa-fy-2024-cj.pdf.
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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 https://www.samhsa.gov/find-help/recovery?
    \69\ See https://store.samhsa.gov/sites/default/files/d7/priv/pep15-fedguideotp.pdf.
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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 https://store.samhsa.gov/sites/default/files/d7/priv/pep15-fedguideotp.pdf.
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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 https://www.cms.gov/newsroom/press-releases/hhs-releases-new-guidance-encourage-states-apply-new-medicaid-reentry-section-1115-demonstration.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \72\ See https://www.samhsa.gov/sites/default/files/2021-letter-state-authorities-mobile.pdf.
    \73\ See https://www.samhsa.gov/medications-substance-use-disorders/become-accredited-opioid-treatment-program.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \74\ See https://www.samhsa.gov/sites/default/files/dear-colleague-letter-fda-samhsa.pdf.
---------------------------------------------------------------------------

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 https://www.samhsa.gov/behavioral-health-equity/ai-an.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \77\ See https://reaganudall.org/news-and-events/events/considerations-buprenorphine-initiation-and-maintenance-care.
    \78\ See https://heal.nih.gov/.
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \79\ See 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.
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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 https://nida.nih.gov/nidamed-medical-health-professionals/health-professions-education/words-matter-terms-to-use-avoid-when-talking-about-addiction.
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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.
---------------------------------------------------------------------------

    \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. https://www.samhsa.gov/data/report/2021-nsduh-annual-national-report.
    \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: http://dx.doi.org/10.15585/mmwr.mm7129e2. See also https://www.seattletimes.com/nation-world/nation/addiction-treatment-medicine-is-vastly-underprescribed-especially-by-race-study-finds/.
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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. 
https://store.samhsa.gov/sites/default/files/pep20-05-02-002.pdf.
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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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     Enhanced access to medications for opioid use disorder, 
such as through take-home doses of methadone and extending interim 
treatment to 180 days;
     Reduced stigma and discrimination based on changes to 
ensure updated language and terminology;
     Clarification of standards applying to Accreditation 
Bodies; and
     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.
---------------------------------------------------------------------------

    \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: http://dx.doi.org/10.15585/mmwr.mm7129e2.
    \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. https://doi.org/10.1016/S2468-2667(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\
---------------------------------------------------------------------------

    \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. https://doi.org/10.15585/mmwr.mm7015a1. See also 
https://trumpwhitehouse.archives.gov/briefings-statements/cea-report-underestimated-cost-opioid-crisis/ 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 https://beyer.house.gov/news/documentsingle.aspx.
    \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. https://doi.org/10.1080/02791072.2015.1014948.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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. https://doi.org/10.1089/pop.2018.0163.
    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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

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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.

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    (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: 
https://dpt2.samhsa.gov/sma163/. 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 detailed description of the applicant's decision-making 
process, including:
    (i) Procedures for initiating and performing onsite accreditation 
surveys of OTPs;
    (ii) Procedures for assessing OTP personnel qualifications;
    (iii) Copies of an application for accreditation, guidelines, 
instructions, and other materials the applicant will send to OTPs 
during the accreditation process, including a request for a complete 
history of prior accreditation activities and a statement that all 
information and data submitted in the application for accreditation is 
true and accurate, and that no material fact has been omitted;
    (iv) Policies and procedures for notifying OTPs and the Secretary 
of deficiencies, for monitoring corrections of deficiencies by OTPs and 
for reporting corrections to the Secretary;
    (v) Policies and procedures for determining OTPs level of adherence 
to this part and Accrediting Body standards and level of accreditation;
    (vi) Policies and procedures for suspending or revoking an OTP's 
accreditation;
    (vii) Policies and procedures that will ensure processing of 
applications for accreditation and applications for renewal of 
accreditation within a timeframe approved by the Secretary; and
    (viii) A description of the applicant's appeals process to allow 
OTPs to contest adverse accreditation decisions;
    (5) Policies and procedures established by the Accreditation Body 
to avoid conflicts of interest, or the appearance of conflicts of 
interest, by the applicant's board members, commissioners, professional 
personnel, consultants, administrative personnel, and other 
representatives;
    (6) A description of the education, experience, and training 
requirements for the applicant's professional staff, accreditation 
survey team membership, and the identification of at least one licensed 
physician with experience treating OUD with MOUD on the applicant's 
staff;
    (7) A description of the applicant's survey team training policies;
    (8) Fee schedules, with supporting cost data;
    (9) Satisfactory assurances that the Body will comply with the 
requirements of Sec.  8.4, including a contingency plan for 
investigating complaints under Sec.  8.4(e);
    (10) Policies and procedures established to protect confidential 
information the applicant will collect or receive in its role as an 
Accreditation Body; and
    (11) Any other supporting information the Secretary may require.
    (c) Application for renewal of approval. An Accreditation Body that 
intends to continue to serve as an Accreditation Body beyond its 
current term shall apply to the Secretary for renewal, or notify the 
Secretary of its intention not to apply for renewal, in accordance with 
the following procedures and schedule:
    (1) At least 9 months before the date of expiration of an 
Accreditation Body's term of approval, the Body shall inform the 
Secretary in writing of its intent to seek renewal.
    (2) The Secretary will notify the applicant of the relevant 
information, materials, and supporting documentation required under 
paragraph (b) of this section that the applicant shall submit as part 
of the renewal procedure.
    (3) At least 3 months before the date of expiration of the 
Accreditation

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


Sec.  8.4  Accreditation Body responsibilities.

    (a) Accreditation surveys and for cause inspections. (1) 
Accreditation Bodies shall conduct routine accreditation surveys for 
initial accreditation, and then at least every three years to allow for 
renewal of certification.
    (2) Accreditation Bodies must agree to conduct for-cause 
inspections upon the request of the Secretary.
    (3) Accreditation decisions shall be fully consistent with the 
policies and procedures submitted as part of the approved Accreditation 
Body application.
    (b) Response to noncompliant programs. (1) If an Accreditation Body 
receives or discovers information that suggests that an OTP is not 
meeting applicable accreditation or certification standards established 
or authorized under this part, or if a survey of the OTP by the 
Accreditation Body demonstrates that such standards are not being met, 
the Accreditation Body shall, within 60 days following discovery of the 
non-compliant condition(s) or applicable survey date:
    (i) Provide written notice to the OTP that identifies each area of 
non-compliance, categorizes each non-compliant condition as either 
``minor'' or ``significant'' as determined by the Accrediting Body, and 
requires the OTP to take corrective action to address the area(s) of 
non-compliance within a schedule, not to exceed 180 days, that the 
Accrediting Body deems appropriate based on the severity of the non-
compliant conditions; and
    (ii) Provide the Secretary with a copy of the written notice 
required under paragraph (b)(1)(i) of this section.
    (2) Once an Accreditation Body provides an OTP with the notice 
described in paragraph (b)(1)(i) of this section, it shall verify the 
implementation of the corrective measures by the OTP within the 
specified schedule. Within 30 days following the last day of the 
specified schedule, the Accreditation Body shall provide written notice 
to the Secretary regarding whether the OTP has implemented the 
corrective measures.
    (3) OTPs that are meeting the requirements of Sec.  8.12, but are 
only required to correct minor non-compliant conditions shall be 
granted a three-year accreditation, beginning from the end date of the 
current and expiring accreditation period. Minor non-compliant 
conditions, found at the time of the survey that are not resolved, as 
determined by the Accreditation Body, within the OTP's three-year 
accreditation period and that remain areas of non-compliance during the 
OTP's subsequent three-year accreditation renewal survey, shall 
automatically be categorized as ``significant'' non-compliant 
conditions for purposes of the renewal survey and must be corrected in 
accordance with paragraph (b)(1)(i) of this section.
    (4) OTPs that are required to correct significant non-compliant 
conditions shall be granted a one-year accreditation, beginning from 
the end date of the current and expiring accreditation period. An OTP's 
accreditation must be revoked if it fails to correct significant non-
compliant conditions within the schedule provided under paragraph 
(b)(1)(i) of this section. If an Accrediting Body verifies that an OTP 
has corrected the significant non-compliant conditions identified 
within the specified schedule, it shall extend the OTP's accreditation 
period by an additional two years.
    (5) In cases of severe non-compliance with the requirements of 
Sec.  8.12 that pose immediate risks to patient health and safety, the 
Accreditation Body shall inform the OTP and Secretary within 48 hours 
and provide a detailed written report of the non-compliance within 5 
business days. The Accreditation Body shall give the OTP 30 days from 
the date of the non-compliance report to correct the non-compliance 
issue(s). A follow-up survey shall be conducted by the Accreditation 
Body within 30 days of the expected correction date to ensure 
successful remediation. Should the OTP not rectify the non-compliance 
within the 30-day period, the Accreditation Body shall revoke the OTP's

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accreditation. The Secretary will then make a decision regarding the 
OTP's certification in accordance with the procedures under Sec.  8.13.
    (c) Recordkeeping. (1) Accreditation Bodies shall maintain, and 
make available as requested by the Secretary, records of their 
accreditation activities for at least 5 years from the creation of the 
record. Such records must contain sufficient detail to support each 
accreditation decision made by the Accreditation Body.
    (2) Accreditation Bodies shall establish procedures to protect 
confidential information collected or received in their role as 
Accreditation Bodies that are consistent with, and that are designed to 
ensure compliance with, all Federal and State laws, including 42 CFR 
part 2.
    (i) Information collected or received for the purpose of carrying 
out Accreditation Body responsibilities shall not be used for any other 
purpose or disclosed, other than to the Secretary or its duly 
designated representatives, unless otherwise required by law or with 
the consent of the OTP.
    (ii) Nonpublic information that the Secretary shares with the 
Accreditation Body concerning an OTP shall not be further disclosed 
except with the written permission of the Secretary.
    (d) Reporting. (1) Accreditation Bodies shall provide to the 
Secretary any documents and information requested by the Secretary 
within 5 days of receipt of the request.
    (2) Accreditation Bodies shall submit a summary of the results of 
each accreditation survey to the Secretary within 90 days following the 
survey visit. Such summaries shall contain sufficient detail to justify 
the accreditation action taken.
    (3) Accreditation Bodies shall provide the Secretary a list of each 
OTP surveyed, and the identity of all individuals involved in the 
conducting and reporting of survey results.
    (4) Accreditation Bodies shall submit to the Secretary the name of 
each OTP for which the Accreditation Body accredits conditionally, 
denies, suspends, or revokes accreditation, and the basis for the 
action, within 48 hours of the action.
    (5) Notwithstanding any reports made to the Secretary under 
paragraphs (d)(1) through (4) of this section, each Accreditation Body 
shall submit to the Secretary semiannually, on January 15 and July 15 
of each calendar year, a report consisting of a summary of the results 
of each accreditation survey conducted in the past year. The summary 
shall contain sufficient detail to justify each accreditation action 
taken.
    (6) All reporting requirements listed in this section shall be 
provided to the Secretary at the address specified in Sec.  8.3(b).
    (e) Complaint response. Accreditation Bodies shall have policies 
and procedures in place to respond to complaints received from the 
Secretary, patients, facility staff, and others within 5 business days 
from the receipt of the complaint. Accreditation Bodies shall also 
agree to notify the Secretary within 5 business days of receipt of a 
complaint from a patient, facility, staff or others, and to inform the 
Secretary of their response to the complaint.
    (f) Modifications of accreditation elements. Accreditation Bodies 
shall obtain the Secretary's written authorization prior to making any 
substantive (i.e., noneditorial) change in accreditation elements.
    (g) Conflicts of interest. The Accreditation Body shall maintain 
and apply policies and procedures that the Secretary has approved in 
accordance with Sec.  8.3 to reduce the possibility of actual conflict 
of interest, or the appearance of a conflict of interest, on the part 
of individuals who act on behalf of the Accreditation Body. Individuals 
who participate in accreditation surveys or otherwise participate in 
the accreditation decision or an appeal of the accreditation decision, 
as well as their spouses and minor children, shall not have a financial 
interest in the OTP that is the subject of the accreditation survey or 
decision.
    (h) Accreditation teams. (1) An Accreditation Body survey team 
shall consist of healthcare professionals with expertise in OUD 
treatment. The Accreditation Body shall consider factors such as the 
size of the OTP, the anticipated number of survey non-compliance 
issues, and the OTP's accreditation history in determining the 
composition of the team. At a minimum, survey teams shall consist of at 
least two healthcare professionals whose combined expertise includes:
    (i) The dispensing and administration of medications subject to 
control under the Controlled Substances Act (21 U.S.C. 801 et seq.);
    (ii) Medical issues relating to the dosing and administration of 
MOUD for the treatment of OUD;
    (iii) Psychosocial counseling of individuals receiving OUD 
treatment; and
    (iv) Organizational and administrative issues associated with OTPs.
    (2) Members of the accreditation team must be able to recuse 
themselves at any time from any survey in which either they or the OTP 
believes there is an actual conflict of interest or the appearance of a 
conflict of interest. Conflict or perceived conflict of interest must 
be documented by the Accreditation Body and made available to the 
Secretary.
    (i) Accreditation fees. Fees charged to OTPs for accreditation 
shall be reasonable. the Secretary generally will find fees to be 
reasonable if the fees are limited to recovering costs to the 
Accreditation Body, including overhead incurred. Accreditation Body 
activities that are not related to accreditation functions are not 
recoverable through fees established for accreditation.
    (1) The Accreditation Body shall make public its fee structure, 
including those factors, if any, contributing to variations in fees for 
different OTPs.
    (2) At the Secretary's request, Accreditation Bodies shall provide 
to the Secretary financial records or other materials, in a manner 
specified by the Secretary, to assist in assessing the reasonableness 
of Accreditation Body fees.


Sec.  8.5  Periodic evaluation of Accreditation Bodies.

    The Secretary will periodically evaluate the performance of 
Accreditation Bodies primarily by inspecting a selected sample of the 
OTPs accredited by the Accrediting Body, and by evaluating the 
Accreditation Body's reports of surveys conducted, to determine whether 
the OTPs surveyed and accredited by the Accreditation Body are in 
compliance with applicable standards under this part. The evaluation 
will include a determination of whether there are major deficiencies in 
the Accreditation Body's performance that, if not corrected, would 
warrant withdrawal of the approval of the Accreditation Body under 
Sec.  8.6.


Sec.  8.6  Withdrawal of approval of Accreditation Bodies.

    If the Secretary determines that an Accreditation Body is not in 
substantial compliance with this subpart, the Secretary shall take 
appropriate action as follows:
    (a) Major deficiencies. If the Secretary determines that the 
Accreditation Body has a major deficiency, such as commission of fraud, 
material false statement, failure to perform a major accreditation 
function satisfactorily, or significant noncompliance with the 
requirements of this subpart, the Secretary shall withdraw approval of 
that Accreditation Body.

[[Page 7555]]

    (1) In the event of a major deficiency, the Secretary shall notify 
the Accreditation Body of the agency's action and the grounds on which 
the approval was withdrawn.
    (2) An Accreditation Body that has lost its approval shall notify 
each OTP that has been accredited or is seeking accreditation that the 
Accreditation Body's approval has been withdrawn. Such notification 
shall be made within a time period and in a manner approved by the 
Secretary.
    (b) Minor deficiencies. If the Secretary determines that the 
Accreditation Body has minor deficiencies in the performance of an 
accreditation function, that are less serious or more limited than the 
types of deficiencies described in paragraph (a) of this section, the 
Secretary will notify the Body that it has 90 days to submit to the 
Secretary a plan of corrective action. The plan must include a summary 
of corrective actions and a schedule for their implementation. The 
Secretary may place the Body on probationary status for a period of 
time determined by the Secretary, or may withdraw approval of the Body 
if corrective action is not taken.
    (1) If the Secretary places an Accreditation Body on probationary 
status, the Body shall notify all OTPs that have been accredited, or 
that are seeking accreditation, of the Accreditation Body's 
probationary status within a time period and in a manner approved by 
the Secretary.
    (2) Probationary status will remain in effect until such time as 
the Body can demonstrate to the satisfaction of the Secretary that it 
has successfully implemented or is implementing the corrective action 
plan within the established schedule, and the corrective actions taken 
have substantially eliminated all identified problems.
    (3) If the Secretary determines that an Accreditation Body that has 
been placed on probationary status is not implementing corrective 
actions satisfactorily or within the established schedule, the 
Secretary may withdraw approval of the Accreditation Body. The 
Accreditation Body shall notify all OTPs that have been accredited, or 
are seeking accreditation, of the Accreditation Body's loss of the 
Secretary's approval within a time period and in a manner approved by 
the Secretary.
    (c) Reapplication. (1) An Accreditation Body that has had its 
approval withdrawn may submit a new application for approval if the 
Body can provide information to the Secretary to establish that the 
problems that were grounds for withdrawal of approval have been 
resolved.
    (2) If the Secretary determines that the new application 
demonstrates that the Body satisfactorily has addressed the causes of 
its previous unacceptable performance, the Secretary may reinstate 
approval of the Accreditation Body.
    (3) The Secretary may request additional information or establish 
additional conditions that must be met before the Secretary approves 
the reapplication.
    (4) The Secretary may refuse to accept an application from a former 
Accreditation Body whose approval was withdrawn because of fraud, 
material false statement, or willful disregard of public health.
    (d) Hearings. An opportunity to challenge an adverse action taken 
regarding withdrawal of approval of an Accreditation Body shall be 
addressed through the relevant procedures set forth in subpart C of 
this part, except that the procedures in Sec.  8.28 for expedited 
review of an immediate suspension would not apply to an Accreditation 
Body that has been notified under paragraph (a) or (b) of this section 
of the withdrawal of its approval.

Subpart C--Certification and Treatment Standards for Opioid 
Treatment Programs


Sec.  8.11  Opioid Treatment Program certification.

    (a) General. (1) An OTP must be the subject of a current, valid 
certification from the Secretary to be considered qualified by the 
Secretary under section 303(g)(1) of the Controlled Substances Act (21 
U.S.C. 823(h)(1)) to dispense MOUD in the treatment of OUD. An OTP must 
be determined to be qualified under section 303(g)(1) of the Controlled 
Substances Act, and must be determined to be qualified by the Attorney 
General under section 303(g)(1), to be registered by the Attorney 
General to dispense MOUD to individuals for treatment of OUD.
    (2) To obtain certification from the Secretary, an OTP must meet 
the Federal Opioid Use Disorder treatment standards in Sec.  8.12, must 
be the subject of a current, valid accreditation by an Accreditation 
Body or other entity designated by the Secretary and must comply with 
any other conditions for certification established by the Secretary.
    (3) OTPs are expected to maintain certification with the Secretary 
and to comply with any other conditions for certification established 
by the Secretary. Certification shall be granted for a term not to 
exceed 3 years, except that certification may be renewed during the 
final certification year if the OTP applies for certification renewal 
in accordance with the steps outlined in paragraph (a)(4) of this 
section.
    (4) OTPs which satisfy the criteria for certification under this 
section may apply for renewal of their certification. OTPs are expected 
to apply for certification renewal during the final year of the OTP's 
certification period. OTPs should take steps to ensure that 
administrative tasks associated with renewal are completed before the 
OTP's certification expires. OTPs may apply for certification renewal 
in accordance with the procedures as outlined in paragraph (b) of this 
section. If an OTP anticipates any delays in routine certification 
renewal, an extension may be requested by submitting to the Secretary a 
statement justifying the extension in accordance with paragraph (e) of 
this section.
    (5) OTPs that are certified and are seeking certification renewal, 
and who have been granted accreditation for one year by an 
Accreditation Body as provided under Sec.  8.4(b)(1)(iii), may receive 
a conditional certification for one year unless the Secretary 
determines that such conditional certification would adversely affect 
patient health. An OTP must obtain a standard 3-year certification, as 
described in paragraph (a)(3) of this section, within the 1-year 
conditional certification period. If standard accreditation is not 
obtained by the OTP within the 1-year conditional certification period, 
the OTP's conditional certification will lapse, and the Attorney 
General will be notified that the OTP's registration should be revoked.
    (6) OTPs whose certification has expired, and who seek re-
certification, will be considered ``new'' programs and will be required 
to apply for provisional certification in accordance with paragraph (d) 
of this section.
    (b) Application for initial or renewal certifications and re-
certification. Applications for certification must be submitted by the 
OTP using form SMA-162. The application for initial or renewal of 
certification shall include, as determined by the Secretary:
    (1) A description of the current accreditation status of the OTP;
    (2) A description of the organizational structure of the OTP;
    (3) The names of the persons responsible for the OTP;
    (4) The addresses of the OTP and of each medication unit or other 
facility under the of the OTP;
    (5) The sources of funding for the OTP and the name and address of 
each

[[Page 7556]]

governmental entity that provides such funding;
    (6) A statement that the OTP will comply with the conditions of 
certification set forth in paragraph (g) of this section; and
    (7) The application shall be signed by the program sponsor who 
shall certify that the information submitted in the application is 
truthful and accurate.
    (8) Applications for re-certification shall include an explanation 
of why the OTP's most recent certification expired and information 
regarding the schedule for an accreditation survey.
    (c) Action on application. (1) Following the Secretary's receipt of 
an application for certification of an OTP, and after consultation with 
the appropriate State authority regarding the qualifications of the 
applicant, the Secretary may grant the application for certification, 
or renew an existing certification, if the Secretary determines that 
the OTP has satisfied the requirements for certification or renewal of 
certification in this section.
    (2) The Secretary may deny the application if the Secretary 
determines that:
    (i) The application for certification is deficient in any respect;
    (ii) The OTP will not be operated in accordance with the Federal 
Opioid Use Disorder treatment standards established under Sec.  8.12;
    (iii) The OTP will not permit an inspection or a survey to proceed, 
or will not permit in a timely manner access to relevant records or 
information; or
    (iv) The OTP has made misrepresentations in obtaining accreditation 
or in applying for certification.
    (3) Within 5 days after it reaches a final determination that an 
OTP meets the requirements for certification in this section, the 
Secretary will notify the Drug Enforcement Administration (DEA) that 
the OTP has been determined to be qualified to provide OUD treatment 
under section 303(g)(1) of the Controlled Substances Act.
    (d) Provisional certification. New OTPs that have not received the 
Secretary's certification previously, except as provided in paragraph 
(a)(6) of this section, who are applying for certification from the 
Secretary, and who have applied for accreditation with an Accreditation 
Body, are eligible to receive provisional certification for up to 1 
year. To receive provisional certification, an OTP shall submit the 
information required by paragraph (b) of this section to the Secretary 
along with a statement identifying the Accreditation Body to which the 
OTP has applied for accreditation, the date on which the OTP applied 
for accreditation, the dates of any accreditation surveys that have 
taken place or are expected to take place, and the expected schedule 
for completing the accreditation process. Provisional certification for 
up to 1 year will be granted, following receipt of the information 
described in this paragraph (d), unless the Secretary determines that 
patient health would be adversely affected by the granting of 
provisional certification.
    (e) Requirements for certification. (1) OTPs shall comply with all 
pertinent Federal and State laws and regulations. Nothing in this part 
is intended to limit the authority of State and, as appropriate, local 
governmental entities to regulate the use of MOUD in the treatment of 
OUD. The provisions of this section requiring compliance with 
requirements imposed by State law, or the submission of applications or 
reports required by the State authority, do not apply to OTPs operated 
directly by the Department of Veterans Affairs, the Indian Health 
Service, or any other department or agency of the United States.
    (2) OTPs shall allow, in accordance with Federal controlled 
substances laws and Federal confidentiality laws, inspections and 
surveys by duly authorized employees of the Department of Health and 
Human Services (HHS) or Substance Abuse and Mental Health Services 
Administration (SAMHSA), by Accreditation Bodies, by the Drug 
Enforcement Administration (DEA), and by authorized employees of any 
other Federal governmental entity with legal authority to conduct 
inspections or surveys on an OTP's premises.
    (3) Disclosure of patient records maintained by an OTP is governed 
by the provisions of 42 CFR part 2 and 45 CFR parts 160 and 164, and 
every program must comply with these regulations, as applicable. 
Records on the receipt, storage, and distribution of MOUD are also 
subject to inspection under Federal controlled substances laws and 
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.). 
Federally sponsored treatment programs are subject to applicable 
Federal confidentiality statutes.
    (4) An OTP or medication unit or any part thereof, including any 
facility or any individual, shall permit a duly authorized employee of 
the Department of Health and Human Services or SAMHSA to have access to 
and to copy all records on the use of MOUD in accordance with the 
provisions of 42 CFR part 2 and 45 CFR parts 160 and 164.
    (5) OTPs shall notify the Secretary in writing within 3 weeks of 
any replacement or other change in the status of the program sponsor or 
medical director.
    (6) OTPs shall comply with all regulations enforced by the DEA 
under 21 CFR chapter II and must be registered by the DEA before 
administering or dispensing MOUD.
    (7) OTPs must operate in accordance with Federal Opioid Use 
Disorder treatment standards and approved accreditation elements.
    (f) Conditions for interim treatment program approval. (1) Before 
an OTP may provide interim treatment, the OTP must receive the approval 
of both the Secretary and the SOTA of the State in which the OTP 
operates.
    (2) Before the Secretary may grant such approval, the OTP must 
provide the Secretary with documentation from the SOTA of the State in 
which the OTP operates demonstrating that:
    (i) Such officer does not object to the providing of interim 
treatment in the State;
    (ii) The OTP seeking to provide such treatment is unable to provide 
access for patients in a comprehensive treatment program within a 
reasonable geographic area within 14 days of the time patients seek 
treatment for OUD;
    (iii) The authorization of the OTP to provide interim treatment 
will not otherwise reduce the capacity of comprehensive treatment 
programs in the State to admit individuals (relative to the date on 
which such officer so certifies); and
    (iv) OTPs providing interim treatment will arrange for each 
individual's transfer to a comprehensive treatment program no later 
than 180 days from the date on which each individual first requested 
treatment. Individuals enrolled in interim treatment shall not be 
discharged without the approval of an OTP practitioner, who shall 
consider on-going and patient-centered treatment needs, which are to be 
documented in the patient record, while awaiting transfer to a 
comprehensive treatment program.
    (3) The Secretary will provide notice to the OTP denying or 
approving the request to provide interim treatment. The OTP shall not 
provide such treatment until it has received such notice from the 
Secretary.
    (g) Exemptions. An OTP may, at the time of application for 
certification or any time thereafter, request from the Secretary 
exemption from the regulatory requirements set forth under this section 
and Sec.  8.12. An example of a case in which an exemption might be 
granted would be for a private practitioner who

[[Page 7557]]

wishes to treat a limited number of patients in a non-metropolitan area 
with few physicians and no OUD treatment services geographically 
accessible, and requests exemption from some of the staffing and 
service standards. The OTP shall support the rationale for the 
exemption with thorough documentation, to be supplied in an appendix to 
the initial application for certification or in a separate submission. 
The Secretary will approve or deny such exemptions at the time of 
application, or any time thereafter, if appropriate. The Secretary 
shall consult with the appropriate State authority prior to taking 
action on an exemption request.
    (h) Medication units, long-term care facilities and hospitals. (1) 
Certified OTPs may establish medication units that are authorized to 
dispense MOUD. Before establishing a medication unit, a certified OTP 
must notify the Secretary by submitting form SMA-162. The OTP must also 
comply with the provisions of 21 CFR part 1300 before establishing a 
medication unit. Medication units shall comply with all pertinent State 
laws and regulations. Medication units include both mobile and brick 
and mortar facilities.
    (2) Specifically, any services that are provided in an OTP may be 
provided in the medication unit, assuming compliance with all 
applicable Federal, State, and local law, and the use of units that 
provide appropriate privacy and have adequate space.
    (3) Certification as an OTP under this part is not required for the 
initiation or continuity of medication treatment or withdrawal 
management of a patient who is admitted to a hospital, long-term care 
facility, or correctional facility, that is registered with the Drug 
Enforcement Administration as a hospital/clinic, for the treatment of 
medical conditions other than OUD, and who requires treatment of OUD 
with methadone during their stay, when such treatment is permitted 
under applicable Federal law.
    (i) The term ``long-term care facility'' is defined in Sec.  8.2. 
Nothing in this section is intended to relieve hospitals, or long-term 
care facilities and correctional facilities that are registered with 
the Drug Enforcement Administration as a hospital/clinic, from their 
obligations to obtain appropriate registration from the Attorney 
General, under section 303(g) of the Controlled Substances Act. 
Treatment provided under this section should always comply with 
applicable Federal laws.
    (ii) [Reserved]


Sec.  8.12  Federal Opioid Use Disorder treatment standards.

    (a) General. OTPs must provide treatment in accordance with the 
standards in this section and must comply with these standards as a 
condition of certification.
    (b) Administrative and organizational structure. (1) An OTP's 
organizational structure and facilities shall be adequate to ensure 
quality patient care and to meet the requirements of all pertinent 
Federal, State, and local laws and regulations. At a minimum, each OTP 
shall formally designate a program sponsor and medical director. The 
program sponsor shall agree on behalf of the OTP to adhere to all 
requirements set forth in this part.
    (2) The medical director shall assume responsibility for all 
medical and behavioral health services performed by the OTP. In 
addition, the medical director shall be responsible for ensuring that 
the OTP is in compliance with all applicable Federal, State, and local 
laws and regulations.
    (c) Continuous quality improvement. (1) An OTP must maintain 
current quality assurance and quality control plans that include, among 
other things, annual reviews of program policies and procedures and 
ongoing assessment of patient outcomes.
    (2) An OTP must maintain a current ``Diversion Control Plan'' or 
``DCP'' as part of its quality assurance program that contains specific 
measures to reduce the possibility of diversion of dispensed MOUD, and 
that assigns specific responsibility to the OTP providers and 
administrative staff for carrying out the diversion control measures 
and functions described in the DCP.
    (d) Staff credentials. Each person engaged in the treatment of OUD 
must have sufficient education, training, and experience, or any 
combination thereof, to enable that person to perform the assigned 
functions. All practitioners and other licensed/certified health care 
providers, including counselors, must comply with the credentialing and 
maintenance of licensure and/or certification requirements of their 
respective professions.
    (e) Patient admission criteria--(1) Comprehensive treatment. An OTP 
shall maintain current procedures designed to 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. Such decisions must be appropriately documented in the 
patient's clinical record. In addition, a health care practitioner 
shall ensure that each patient voluntarily chooses treatment with MOUD 
and that all relevant facts concerning the use of MOUD are clearly and 
adequately explained to the patient, and that each patient provides 
informed consent to treatment.
    (2) Comprehensive treatment for persons under age 18. Except in 
States where State law grants persons under 18 years of age the ability 
to consent to OTP treatment without the consent of another, no person 
under 18 years of age may be admitted to OTP treatment unless a parent, 
legal guardian, or responsible adult designated by the relevant State 
authority consents in writing to such treatment.
    (3) Withdrawal management. An OTP shall maintain current procedures 
that are designed to ensure that those patients who choose to taper 
from MOUD are provided the opportunity to do so with informed consent 
and at a mutually agreed-upon rate that minimizes taper-related risks. 
Such consent must be documented in the clinical record by the treating 
practitioner.
    (f) Required services--(1) General. OTPs shall provide adequate 
medical, counseling, vocational, educational, and other screening, 
assessment, and treatment services to meet patient needs, with the 
combination and frequency of services tailored to each individual 
patient based on an individualized assessment and the patient's care 
plan that was created after shared decision making between the patient 
and the clinical team. These services must be available at the primary 
facility, except where the program sponsor has entered into a 
documented agreement with a private or public agency, organization, 
practitioner, or institution to provide these services to patients 
enrolled in the OTP. The program sponsor, in any event, must be able to 
document that these services are fully and reasonably available to 
patients.
    (2) Initial medical examination. (i) OTPs shall require each 
patient to undergo an initial medical examination. The initial medical 
examination is comprised of two parts:
    (A) A screening examination to ensure that the patient meets 
criteria for admission and that there are no contraindications to 
treatment with MOUD; and
    (B) A full history and examination, to determine the patient's 
broader health status, with lab testing as determined to be required by 
an appropriately licensed

[[Page 7558]]

practitioner. A patient's refusal to undergo lab testing for co-
occurring physical health conditions should not preclude them from 
access to treatment, provided such refusal does not have potential to 
negatively impact treatment with medications.
    (ii) Assuming no contraindications, a patient may commence 
treatment with MOUD after the screening examination has been completed. 
Both the screening examination and full examination must be completed 
by an appropriately licensed practitioner. If the licensed practitioner 
is not an OTP practitioner, the screening examination must be completed 
no more than seven days prior to OTP admission. Where the examination 
is performed outside of the OTP, the written results and narrative of 
the examination, as well as available lab testing results, must be 
transmitted, consistent with applicable privacy laws, to the OTP, and 
verified by an OTP practitioner.
    (iii) A full in-person physical examination, including the results 
of serology and other tests that are considered to be clinically 
appropriate, must be completed within 14 calendar days following a 
patient's admission to the OTP. The full exam can be completed by a 
non-OTP practitioner, if the exam is verified by a licensed OTP 
practitioner as being true and accurate and transmitted in accordance 
with applicable privacy laws.
    (iv) Serology testing and other testing as deemed medically 
appropriate by the licensed OTP practitioner based on the screening or 
full history and examination, drawn not more than 30 days prior to 
admission to the OTP, may form part of the full history and 
examination.
    (v) The screening and full examination may be completed via 
telehealth for those patients being admitted for treatment at the OTP 
with either buprenorphine or methadone, if a practitioner or primary 
care provider, determines that an adequate evaluation of the patient 
can be accomplished via telehealth. When using telehealth, the 
following caveats apply:
    (A) In evaluating patients for treatment with schedule II 
medications (such as Methadone), audio-visual telehealth platforms must 
be used, except when not available to the patient. When not available, 
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. The OTP 
practitioner shall review the examination results and order treatment 
medications as indicated.
    (B) 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. The OTP practitioner shall review the 
examination results and order treatment medications as indicated.
    (3) Special services for pregnant patients. OTPs must maintain 
current policies and procedures that reflect the special needs and 
priority for treatment admission of patients with OUD who are pregnant. 
Pregnancy should be confirmed. Evidence-based treatment protocols for 
the pregnant patient, such as split dosing regimens, may be instituted 
after assessment by an OTP practitioner and documentation that confirms 
the clinical appropriateness of such an evidence-based treatment 
protocol. Prenatal care and other sex-specific services, including 
reproductive health services, for pregnant and postpartum patients must 
be provided and documented either by the OTP or by referral to 
appropriate healthcare practitioners. Specific services, including 
reproductive health services, for pregnant and postpartum patients must 
be provided and documented either by the OTP or by referral to 
appropriate healthcare practitioners.
    (4) Initial and periodic physical and behavioral health assessment 
services. (i) Each patient admitted to an OTP shall be given a physical 
and behavioral health assessment, which includes but is not limited to 
screening for imminent risk of harm to self or others, within 14 
calendar days following admission, and periodically by appropriately 
licensed/credentialed personnel. These assessments must address the 
need for and/or response to treatment, adjust treatment interventions, 
including MOUD, as necessary, and provide a patient-centered plan of 
care. The full, initial psychosocial assessment must be completed 
within 14 calendar days of admission and include preparation of a care 
plan that includes the patient's goals and mutually agreed-upon actions 
for the patient to meet those goals, including harm reduction 
interventions; the patient's needs and goals in the areas of education, 
vocational training, and employment; and the medical and psychiatric, 
psychosocial, economic, legal, housing, and other recovery support 
services that a patient needs and wishes to pursue. The care plan also 
must identify the recommended frequency with which services are to be 
provided. The plan must be reviewed and updated to reflect responses to 
treatment and recovery support services, and adjustments made that 
reflect changes in the context of the person's life, their current 
needs for and interests in medical, psychiatric, social, and 
psychological services, and current needs for and interests in 
education, vocational training, and employment services.
    (ii) The periodic physical examination should occur not less than 
one time each year and be conducted by an OTP practitioner. The 
periodic physical examination should include review of MOUD dosing, 
treatment response, other substance use disorder treatment needs, 
responses and patient-identified goals, and other relevant physical and 
psychiatric treatment needs and goals. The periodic physical 
examination should be documented in the patient's clinical record.
    (5) Counseling and psychoeducational services. (i) OTPs must 
provide adequate substance use disorder counseling and psychoeducation 
to each patient as clinically necessary and mutually agreed-upon, 
including harm reduction education and recovery-oriented counseling. 
This counseling shall be provided by a program counselor, qualified by 
education, training, or experience to assess the psychological and 
sociological background of patients, and engage with patients, to 
contribute to the appropriate care plan for the patient and to monitor 
and update patient progress. Patient refusal of counseling shall not 
preclude them from receiving MOUD.
    (ii) OTPs must provide counseling on preventing exposure to, and 
the transmission of, human immunodeficiency virus (HIV), viral 
hepatitis, and sexually transmitted infections (STIs) and either 
directly provide services and treatments or actively link to treatment 
each patient admitted or readmitted to treatment who has received 
positive test results for these conditions from initial and/or periodic 
medical examinations.
    (iii) OTPs must provide directly, or through referral to adequate 
and reasonably accessible community resources, vocational training, 
education, and employment services for patients who request such 
services or for whom these needs have been identified and mutually 
agreed-upon as beneficial by the patient and program staff.
    (6) Drug testing services. When conducting random drug testing, 
OTPs must use drug tests that have received the Food and Drug 
Administration's (FDA) marketing authorization for commonly used and 
misused substances that may impact patient safety, recovery, or 
otherwise complicate substance use disorder treatment, at a frequency 
that is

[[Page 7559]]

in accordance with generally accepted clinical practice and as 
indicated by a patient's response to and stability in treatment, but no 
fewer than eight random drug tests per year patient, allowing for 
extenuating circumstances at the individual patient level. This 
requirement does not preclude distribution of legal harm reduction 
supplies that allow an individual to test their personal drug supply 
for adulteration with substances that increase the risk of overdose.
    (g) Recordkeeping and patient confidentiality. (1) OTPs shall 
establish and maintain a recordkeeping system that is adequate to 
document and monitor patient care. This system is required to comply 
with all Federal and State reporting requirements relevant to MOUD 
approved for use in treatment of OUD. All records are required to be 
kept confidential in accordance with all applicable Federal and State 
requirements.
    (2) OTPs shall include, as an essential part of the recordkeeping 
system, documentation in each patient's record that the OTP made a good 
faith effort to determine whether the patient is enrolled in any other 
OTP. A patient enrolled in an OTP shall not be permitted to obtain 
treatment in any other OTP except in circumstances involving an 
inability to access care at the patient's OTP of record. Such 
circumstances include, but are not limited to, travel for work or 
family events, temporary relocation, or an OTP's temporary closure. If 
the medical director or program practitioner of the OTP in which the 
patient is enrolled determines that such circumstances exist, the 
patient may seek treatment at another OTP, provided the justification 
for the particular circumstances are noted in the patient's record both 
at the OTP in which the patient is enrolled and at the OTP that will 
provide the MOUD.
    (h) Medication administration, dispensing, and use. (1) OTPs must 
ensure that MOUD are administered or dispensed only by a practitioner 
licensed under the appropriate State law and registered under the 
appropriate State and Federal laws to administer or dispense MOUD, or 
by an agent of such a practitioner, supervised by and under the order 
of the licensed practitioner and if consistent with Federal and State 
law.
    (2) OTPs shall use only those MOUD that are 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. In 
addition, OTPs who are fully compliant with the protocol of an 
investigational use of a drug and other conditions set forth in the 
application may administer a drug that has been authorized by the Food 
and Drug Administration under an investigational new drug application 
under section 505(i) of the Federal Food, Drug, and Cosmetic Act for 
investigational use in the treatment of OUD. Currently the following 
MOUD will be considered to be approved by the Food and Drug 
Administration for use in the treatment of OUD:
    (i) Methadone;
    (ii) Buprenorphine and buprenorphine combination products that have 
been approved for use in the treatment of OUD; and
    (iii) Naltrexone.
    (3) OTPs shall maintain current procedures that are adequate to 
ensure that the following dosage form and initial dosing requirements 
are met:
    (i) Methadone shall be administered or dispensed only in oral form 
and shall be formulated in such a way as to reduce its potential for 
parenteral misuse.
    (ii) For each new patient enrolled in an OTP, the initial dose of 
methadone shall be individually determined and shall include 
consideration of the type(s) of opioid(s) involved in the patient's 
opioid use disorder, other medications or substances being taken, 
medical history, and severity of opioid withdrawal. The total dose for 
the first day should not exceed 50 milligrams unless the OTP 
practitioner, licensed under the appropriate State law and registered 
under the appropriate State and Federal laws to administer or dispense 
MOUD, finds sufficient medical rationale, including but not limited to 
if the patient is transferring from another OTP on a higher dose that 
has been verified, and documents in the patient's record that a higher 
dose was clinically indicated.
    (4) OTPs shall maintain current procedures adequate to ensure that 
each MOUD used by the program is administered and dispensed in 
accordance with its FDA approved product labeling. The program must 
ensure that any significant deviations from the approved labeling, 
including deviations with regard to dose, frequency, or the conditions 
of use described in the approved labeling, are specifically documented 
in the patient's record.
    (i) Unsupervised or ``take-home'' medication doses. Unsupervised or 
``take-home'' medication doses may be provided under the following 
circumstances:
    (1) Any patient in comprehensive treatment may receive their 
individualized take-home doses as ordered for days that the clinic is 
closed for business, including one weekend day (e.g., Sunday) and State 
and Federal holidays, no matter their length of time in treatment.
    (2) OTP decisions on dispensing MOUD to patients for unsupervised 
use beyond that set forth in paragraph (i)(1) of this section shall be 
determined by an appropriately licensed OTP medical practitioner or the 
medical director. In determining which patients may receive 
unsupervised medication doses, the medical director or program medical 
practitioner shall consider, among other pertinent factors that 
indicate that the therapeutic benefits of unsupervised doses outweigh 
the risks, the following criteria:
    (i) Absence of active substance use disorders, other physical or 
behavioral health conditions that increase the risk of patient harm as 
it relates to the potential for overdose, or the ability to function 
safely;
    (ii) Regularity of attendance for supervised medication 
administration;
    (iii) Absence of serious behavioral problems that endanger the 
patient, the public or others;
    (iv) Absence of known recent diversion activity;
    (v) Whether take-home medication can be safely transported and 
stored; and
    (vi) Any other criteria that the medical director or medical 
practitioner considers relevant to the patient's safety and the 
public's health.
    (3) Such determinations and the basis for such determinations 
consistent with the criteria outlined in paragraph (i)(2) of this 
section shall be documented in the patient's medical record. If it is 
determined that a patient is safely able to manage unsupervised doses 
of MOUD, the dispensing restrictions set forth in paragraphs (i)(3)(i) 
through (iii) of this section apply. The dispensing restrictions set 
forth in paragraphs (i)(3)(i) through (iii) of this section do not 
apply to buprenorphine and buprenorphine products listed under 
paragraph (h)(2)(ii) of this section.
    (i) During the first 14 days of treatment, the take-home supply 
(beyond that of paragraph (i)(1) of this section) is limited to 7 days. 
It remains within the OTP practitioner's discretion to determine the 
number of take-home doses up to 7 days, but decisions must be based on 
the criteria listed in paragraph (i)(2) of this section. The rationale 
underlying the decision to provide unsupervised doses of methadone must 
be documented in the patient's clinical record, consistent with 
paragraph (g)(2) of this section.

[[Page 7560]]

    (ii) From 15 days of treatment, the take-home supply (beyond that 
of paragraph (i)(1) of this section) is limited to 14 days. It remains 
within the OTP practitioner's discretion to determine the number of 
take-home doses up to 14 days, but this determination must be based on 
the criteria listed in paragraph (i)(2) of this section. The rationale 
underlying the decision to provide unsupervised doses of methadone must 
be documented in the patient's clinical record, consistent with 
paragraph (g)(2) of this section.
    (iii) From 31 days of treatment, the take-home supply (beyond that 
of paragraph (i)(1) of this section) provided to a patient is not to 
exceed 28 days. It remains within the OTP practitioner's discretion to 
determine the number of take-home doses up to 28 days, but this 
determination must be based on the criteria listed in paragraph (i)(2) 
of this section. The rationale underlying the decision to provide 
unsupervised doses of methadone must be documented in the patient's 
clinical record, consistent with paragraph (g)(2) of this section.
    (4) OTPs must maintain current procedures adequate to identify the 
theft or diversion of take-home medications, including labeling 
containers with the OTP's name, address, and telephone number. Programs 
also must ensure that each individual take-home dose is packaged in a 
manner that is designed to reduce the risk of accidental ingestion, 
including child-proof containers (see Poison Prevention Packaging Act, 
Pub. L. 91-601 (15 U.S.C. 1471 et seq.)). Programs must provide 
education to each patient on: Safely transporting medication from the 
OTP to their place of residence; and the safe storage of take-home 
doses at the individual's place of residence, including child and 
household safety precautions. The provision of this education should be 
documented in the patient's clinical record.
    (j) Interim treatment. (1) The program sponsor of an OTP may admit 
an individual, who is eligible for admission to comprehensive 
treatment, into interim treatment if comprehensive services are not 
readily available within a reasonable geographic area and within 14 
days of the individual's seeking treatment. At least two drug tests 
shall be obtained from patients during the maximum of 180 days 
permitted for interim treatment. A program shall establish and follow 
reasonable criteria for establishing priorities for moving patients 
from interim to comprehensive treatment. These transition criteria 
shall be in writing and shall include, at a minimum, prioritization of 
pregnant patients in admitting patients to interim treatment and from 
interim to comprehensive treatment. Interim treatment shall be provided 
in a manner consistent with all applicable Federal and State laws, 
including sections 1923, 1927(a), and 1976 of the Public Health Service 
Act (21 U.S.C. 300x-23, 300x-27(a), and 300y-11).
    (2) The program shall notify the SOTA when a patient begins interim 
treatment, when a patient leaves interim treatment, and before the date 
of transfer to comprehensive services, and shall document such 
notifications.
    (3) The Secretary may revoke the interim authorization for programs 
that fail to comply with the provisions of this paragraph (j). 
Likewise, the Secretary will consider revoking the interim 
authorization of a program if the State in which the program operates 
is not in compliance with the provisions of Sec.  8.11(h).
    (4) All requirements for comprehensive treatment apply to interim 
treatment with the following exceptions:
    (i) A primary counselor is not required to be assigned to the 
patient, but crisis services, including shelter support, should be 
available;
    (ii) Interim treatment cannot be provided for longer than 180 days 
in any 12-month period;
    (iii) By day 120, a plan for continuing treatment beyond 180 days 
must be created, and documented in the patient's clinical record; and
    (iv) Formal counseling, vocational training, employment, economic, 
legal, educational, and other recovery support services described in 
paragraphs (f)(4) and (f)(5)(i) and (iii) of this section are not 
required to be offered to the patient. However, information pertaining 
to locally available, community-based resources for ancillary services 
should be made available to individual patients in interim treatment.


Sec.  8.13  Revocation of accreditation and Accreditation Body 
approval.

    (a) The Secretary's action following revocation of accreditation. 
If an Accreditation Body revokes an OTP's accreditation, the Secretary 
may conduct an investigation into the reasons for the revocation. 
Following such investigation, the Secretary may determine that the 
OTP's certification should no longer be in effect, at which time the 
Secretary will initiate procedures to revoke the program's 
certification in accordance with Sec.  8.14. Alternatively, the 
Secretary may determine that another action or combination of actions 
would better serve the public health, including the establishment and 
implementation of a corrective plan of action that will permit the 
certification to continue in effect while the OTP seeks 
reaccreditation.
    (b) Accreditation Body approval. (1) If the Secretary withdraws the 
approval of an Accreditation Body under Sec.  8.6, the certifications 
of OTPs accredited by such Body shall remain in effect for a period of 
1 year after the date of withdrawal of approval of the Accreditation 
Body, unless the Secretary determines that to protect public health or 
safety, or because the Accreditation Body fraudulently accredited 
treatment programs, the certifications of some or all of the programs 
should be revoked or suspended or that a shorter time period should be 
established for the certifications to remain in effect. The Secretary 
may extend the time in which a certification remains in effect under 
this paragraph (b)(1) on a case-by-case basis.
    (2) Within 1 year from the date of withdrawal of approval of an 
Accreditation Body, or within any shorter period of time established by 
the Secretary, OTPs currently accredited by the Accreditation Body must 
obtain accreditation from another Accreditation Body. The Secretary may 
extend the time period for obtaining reaccreditation on a case-by-case 
basis.


Sec.  8.14  Suspension or revocation of certification.

    (a) Revocation. Except as provided in paragraph (b) of this 
section, the Secretary may revoke the certification of an OTP if the 
Secretary finds, after providing the program sponsor with notice and an 
opportunity for a hearing in accordance with this subpart, that the 
program sponsor, or any employee of the OTP:
    (1) Has been found to have engaged in misrepresentation in 
obtaining the certification;
    (2) Has failed to comply with the Federal Opioid Use Disorder 
treatment standards in any respect;
    (3) Has failed to comply with reasonable requests from the 
Secretary or from an Accreditation Body for records, information, 
reports, or materials that are necessary to determine the continued 
eligibility of the OTP for certification or continued compliance with 
the Federal Opioid Use Disorder treatment standards; or
    (4) Has refused a reasonable request of a duly designated 
inspector, Drug Enforcement Administration (DEA) Inspector, State 
Inspector, or Accreditation Body representative for permission to 
inspect the program or the program's operations or its records.

[[Page 7561]]

    (b) Suspension. Whenever the Secretary has reason to believe that 
revocation may be required and that immediate action is necessary to 
protect public health or safety, the Secretary may immediately suspend 
the certification of an OTP, and notify the Attorney General that the 
OTP's registration should be suspended, before holding a hearing under 
this subpart. The Secretary may immediately suspend as well as propose 
revocation of the certification of an OTP before holding a hearing 
under this subpart if the Secretary makes a finding described in 
paragraph (a) of this section and also determines that:
    (1) The failure to comply with the Federal Opioid Use Disorder 
treatment standards presents an imminent danger to the public health or 
safety;
    (2) The refusal to permit inspection makes immediate suspension 
necessary; or
    (3) There is reason to believe that the failure to comply with the 
Federal Opioid Use Disorder treatment standards was intentional or was 
associated with fraud.
    (c) Written notification. In the event that the Secretary suspends 
the certification of an OTP in accordance with paragraph (b) of this 
section or proposes to revoke the certification of an OTP in accordance 
with paragraph (a) of this section, the Secretary shall promptly 
provide the sponsor of the OTP with written notice of the suspension or 
proposed revocation by facsimile transmission, personal service, 
commercial overnight delivery service, or certified mail, return 
receipt requested. Such notice shall state the reasons for the action, 
state that the OTP may seek review of the action in accordance with the 
procedures in this subpart, and identify the reviewing official to whom 
a written request for review may be submitted.
    (d) Procedure. (1) If the Secretary suspends certification in 
accordance with paragraph (b) of this section:
    (i) The Secretary will immediately notify DEA that the OTP's 
registration should be suspended under 21 U.S.C. 824(d); and
    (ii) the Secretary will provide an opportunity for a hearing under 
this subpart.
    (2) Suspension of certification under paragraph (b) of this section 
shall remain in effect until the agency determines that:
    (i) The basis for the suspension cannot be substantiated;
    (ii) Violations of required standards have been corrected to the 
agency's satisfaction; or
    (iii) The OTP's certification shall be revoked.


Sec.  8.15  Forms.

    (a) SMA-162--Application for Certification to Use Medications for 
Opioid Use Disorder.
    (b) SMA-163--Application for Becoming an Accreditation Body under 
Sec.  8.3.

Subpart D--Procedures for Informal Review of Suspension or Proposed 
Revocation of OTP Certification, and of Adverse Action Regarding 
Withdrawal of Approval of an Accreditation Body


Sec.  8.21  Applicability.

    The procedures in this subpart apply when:
    (a) The Secretary has notified an OTP in writing that its 
certification under the regulations in subpart B of this part has been 
suspended or that the Secretary proposes to revoke the certification; 
and
    (b) The OTP has, within 30 days of the date of the notification or 
within 3 days of the date of the notification when seeking an expedited 
review of a suspension, requested in writing to the reviewing official, 
an opportunity for an informal review of the suspension or proposed 
revocation.
    (c) The Secretary has notified an Accreditation Body of an adverse 
action taken regarding withdrawal of approval of the Accreditation Body 
under the regulations in subpart A of this part; and
    (d) The Accreditation Body has, within 30 days of the date of the 
notification, requested in writing an opportunity for a review of the 
adverse action.


Sec.  8.22  Definitions.

    The following definitions apply to this subpart:
    Appellant means:
    (1) The OTP which has been notified of its suspension or proposed 
revocation of its certification under the regulations of this part and 
has requested a review of the suspension or proposed revocation; or
    (2) The Accreditation Body which has been notified of adverse 
action regarding withdrawal of approval under the regulations of this 
subpart and has requested a review of the adverse action.
    Respondent means SAMHSA.
    Reviewing official means the person or persons designated by the 
Secretary who will informally review the suspension or proposed 
revocation. The reviewing official may be assisted by one or more 
Department of Health and Human Services (HHS) officers or employees or 
consultants in assessing and weighing the scientific and technical 
evidence and other information submitted by the appellant and 
respondent on the reasons for the suspension and proposed revocation.


Sec.  8.23  Limitation on issues subject to review.

    The scope of this informal review shall be limited to the facts 
relevant to any suspension, or proposed revocation, or adverse action, 
the necessary interpretations of the facts, the regulations in this 
subpart, and other relevant law.


Sec.  8.24  Specifying who represents the parties.

    The appellant's request for an informal review shall specify the 
name, address, and phone number of the appellant's representative. In 
its first written submission to the reviewing official, the respondent 
shall specify the name, address, and phone number of the respondent's 
representative.


Sec.  8.25  Informal review and the reviewing official's response.

    (a) Request for review. Within 30 days of the date of the notice of 
the suspension or proposed revocation, the appellant must submit a 
written request to the reviewing official seeking review, unless some 
other time period is agreed to by the parties. A copy must also be sent 
to the respondent. The request for review must include a copy of the 
notice of suspension, proposed revocation, or adverse action, a brief 
statement of why the decision to suspend, propose revocation, or take 
an adverse action is incorrect, and the appellant's request for an oral 
presentation, if desired.
    (b) Acknowledgment. Within 5 days after receiving the request for 
review, the reviewing official will send an acknowledgment and advise 
the appellant of the next steps. The reviewing official will also send 
a copy of the acknowledgment to the respondent.


Sec.  8.26  Preparation of the review file and written arguments.

    The appellant and the respondent each participate in developing the 
file for the reviewing official and in submitting written arguments. 
The procedures for development of the review file and submission of 
written argument are:
    (a) Appellant's documents and brief. Within 30 days after receiving 
the acknowledgment of the request for review, the appellant shall 
submit to the reviewing official the following (with a copy to the 
respondent):
    (1) A review file containing the documents supporting appellant's

[[Page 7562]]

argument, tabbed and organized chronologically, and accompanied by an 
index identifying each document. Only essential documents should be 
submitted to the reviewing official.
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining why respondent's decision to suspend or propose revocation 
of appellant's certification or to take adverse action regarding 
withdrawal of approval of the Accreditation Body is incorrect 
(appellant's brief).
    (b) Respondent's documents and brief. Within 30 days after 
receiving a copy of the acknowledgment of the request for review, the 
respondent shall submit to the reviewing official the following (with a 
copy to the appellant):
    (1) A review file containing documents supporting respondent's 
decision to suspend or revoke appellant's certification, or approval as 
an Accreditation Body, tabbed and organized chronologically, and 
accompanied by an index identifying each document. Only essential 
documents should be submitted to the reviewing official.
    (2) A written statement, not exceeding 20 double-spaced pages in 
length, explaining the basis for suspension, proposed revocation, or 
adverse action (respondent's brief).
    (c) Reply briefs. Within 10 days after receiving the opposing 
party's submission, or 20 days after receiving acknowledgment of the 
request for review, whichever is later, each party may submit a short 
reply not to exceed 10 double-spaced pages.
    (d) Cooperative efforts. Whenever feasible, the parties should 
attempt to develop a joint review file.
    (e) Excessive documentation. The reviewing official may take any 
appropriate steps to reduce excessive documentation, including the 
return of or refusal to consider documentation found to be irrelevant, 
redundant, or unnecessary.
    (f) Discovery. The use of interrogatories, depositions, and other 
forms of discovery shall not be allowed.


Sec.  8.27  Opportunity for oral presentation.

    (a) Electing oral presentation. If an opportunity for an oral 
presentation is desired, the appellant shall request it at the time it 
submits its written request for review to the reviewing official. The 
reviewing official will grant the request if the official determines 
that the decision-making process will be substantially aided by oral 
presentations and arguments. The reviewing official may also provide 
for an oral presentation at the official's own initiative or at the 
request of the respondent.
    (b) Presiding official. The reviewing official or designee will be 
the presiding official responsible for managing the oral presentations.
    (c) Preliminary conference. The presiding official may hold a 
prehearing conference (usually a telephone conference call) to consider 
any of the following: Simplifying and clarifying issues; stipulations 
and admissions; limitations on evidence and witnesses that will be 
presented at the hearing; time allotted for each witness and the 
hearing altogether; scheduling the hearing; and any other matter that 
will assist in the review process. Normally, this conference will be 
conducted informally and off the record; however, the presiding 
official may, at the presiding official's discretion, produce a written 
document summarizing the conference or transcribe the conference.
    (d) Time and place of oral presentation. The presiding official 
will attempt to schedule the oral presentation within 45 days of the 
date appellant's request for review is received or within 15 days of 
submission of the last reply brief, whichever is later. The oral 
presentation will be held at a time and place determined by the 
presiding official following consultation with the parties.
    (e) Conduct of the oral presentation--(1) General. The presiding 
official is responsible for conducting the oral presentation. The 
presiding official may be assisted by one or more HHS officers or 
employees or consultants in conducting the oral presentation and 
reviewing the evidence. While the oral presentation will be kept as 
informal as possible, the presiding official may take all necessary 
steps to ensure an orderly proceeding.
    (2) Burden of proof/standard of proof. In all cases, the respondent 
bears the burden of proving by a preponderance of the evidence that its 
decision to suspend, propose revocation, or take adverse action is 
appropriate. The appellant, however, has a responsibility to respond to 
the respondent's allegations with evidence and argument to show that 
the respondent is incorrect.
    (3) Admission of evidence. The rules of evidence do not apply, and 
the presiding official will generally admit all testimonial evidence 
unless it is clearly irrelevant, immaterial, or unduly repetitious. 
Each party may make an opening and closing statement, may present 
witnesses as agreed upon in the pre-hearing conference or otherwise, 
and may question the opposing party's witnesses. Since the parties have 
ample opportunity to prepare the review file, a party may introduce 
additional documentation during the oral presentation only with the 
permission of the presiding official. The presiding official may 
question witnesses directly and take such other steps necessary to 
ensure an effective and efficient consideration of the evidence, 
including setting time limitations on direct and cross-examinations.
    (4) Motions. The presiding official may rule on motions including, 
for example, motions to exclude or strike redundant or immaterial 
evidence, motions to dismiss the case for insufficient evidence, or 
motions for summary judgment. Except for those made during the hearing, 
all motions and opposition to motions, including argument, must be in 
writing and be no more than 10 double-spaced pages in length. The 
presiding official will set a reasonable time for the party opposing 
the motion to reply.
    (5) Transcripts. The presiding official shall have the oral 
presentation transcribed. Either party may request a copy of the 
transcript and the requesting party shall be responsible for paying for 
its copy of the transcript.
    (f) Obstruction of justice or making of false statements. 
Obstruction of justice or the making of false statements by a witness 
or any other person may be the basis for a criminal prosecution under 
18 U.S.C. 1001 or 1505.
    (g) Post-hearing procedures. At the presiding official's 
discretion, the presiding official may require or permit the parties to 
submit post-hearing briefs or proposed findings and conclusions. Each 
party may submit comments on any major prejudicial errors in the 
transcript.


Sec.  8.28  Expedited procedures for review of immediate suspension.

    (a) Applicability. When the Secretary notifies an OTP in writing 
that its certification has been immediately suspended, the appellant 
may request an expedited review of the suspension and any proposed 
revocation. The appellant must submit this request in writing to the 
reviewing official within 10 days of the date the OTP received notice 
of the suspension. The request for review must include a copy of the 
suspension and any proposed revocation, a brief statement of why the 
decision to suspend and propose revocation is incorrect, and the 
appellant's request for an oral presentation, if desired. A copy of the 
request for review must also be sent to the respondent.
    (b) Reviewing official's response. As soon as practicable after the 
request for review is received, the reviewing official

[[Page 7563]]

will send an acknowledgment with a copy to the respondent.
    (c) Review file and briefs. Within 10 days of the date the request 
for review is received, but no later than 2 days before an oral 
presentation, each party shall submit to the reviewing official the 
following:
    (1) A review file containing essential documents relevant to the 
review, tabbed, indexed, and organized chronologically; and
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining the party's position concerning the suspension and any 
proposed revocation. No reply brief is permitted.
    (d) Oral presentation. If an oral presentation is requested by the 
appellant or otherwise granted by the reviewing official in accordance 
with Sec.  8.27(a), the presiding official will attempt to schedule the 
oral presentation within 20 to 30 days of the date of appellant's 
request for review at a time and place determined by the presiding 
official following consultation with the parties. The presiding 
official may hold a pre-hearing conference in accordance with Sec.  
8.27(c) and will conduct the oral presentation in accordance with the 
procedures of Sec.  8.27(e), (f), and (g).
    (e) Written decision. The reviewing official shall issue a written 
decision upholding or denying the suspension or proposed revocation and 
will attempt to issue the decision within 7 to 10 days of the date of 
the oral presentation or within 3 days of the date on which the 
transcript is received or the date of the last submission by either 
party, whichever is later. All other provisions set forth in Sec.  8.33 
apply.
    (f) Transmission of written communications. Because of the 
importance of timeliness for the expedited procedures in this section, 
all written communications between the parties and between either party 
and the reviewing official shall be sent by facsimile transmission, 
personal service, or commercial overnight delivery service.


Sec.  8.29  Ex parte communications.

    For the purposes of maintaining the equity of informal review 
proceedings, except for routine administrative and procedural matters 
or as described in Sec. Sec.  8.22(2) and 8.27(e), a party shall not 
communicate with the reviewing or presiding official without notice to 
the other party.


Sec.  8.30  Transmission of written communications by reviewing 
official and calculation of deadlines.

    (a) Timely review. Because of the importance of a timely review, 
the reviewing official should normally transmit written communications 
to either party by facsimile transmission, personal service, or 
commercial overnight delivery service, or certified mail, return 
receipt requested, in which case the date of transmission or day 
following mailing will be considered the date of receipt. In the case 
of communications sent by regular mail, the date of receipt will be 
considered 3 days after the date of mailing.
    (b) Due date. In counting days, include Saturdays, Sundays, and 
holidays. However, if a due date falls on a Saturday, Sunday, or 
Federal holiday, then the due date is the next Federal working day.


Sec.  8.31  Authority and responsibilities of the reviewing official.

    In addition to any other authority specified in this subpart, the 
reviewing official and the presiding official, with respect to those 
authorities involving the oral presentation, shall have the authority 
to issue orders; examine witnesses; take all steps necessary for the 
conduct of an orderly hearing; rule on requests and motions; grant 
extensions of time for good reasons; dismiss for failure to meet 
deadlines or other requirements; order the parties to submit relevant 
information or witnesses; remand a case for further action by the 
respondent; waive or modify the procedures in this subpart in a 
specific case, usually with notice to the parties; reconsider a 
decision of the reviewing official where a party promptly alleges a 
clear error of fact or law; and to take any other action necessary to 
resolve disputes in accordance with the objectives of the procedures in 
this subpart.


Sec.  8.32  Administrative record.

    The administrative record of review consists of the review file; 
other submissions by the parties; transcripts or other records of any 
meetings, conference calls, or oral presentation; evidence submitted at 
the oral presentation; and orders and other documents issued by the 
reviewing and presiding officials.


Sec.  8.33  Written decision.

    (a) Issuance of decision. The reviewing official shall issue a 
written decision upholding or denying the suspension, proposed 
revocation, or adverse action. The decision will set forth the reasons 
for the decision and describe the basis for that decision in the 
record. Furthermore, the reviewing official may remand the matter to 
the respondent for such further action as the reviewing official deems 
appropriate.
    (b) Date of decision. The reviewing official will attempt to issue 
the decision within 15 days of the date of the oral presentation, the 
date on which the transcript is received, or the date of the last 
submission by either party, whichever is later. If there is no oral 
presentation, the decision will normally be issued within 15 days of 
the date of receipt of the last reply brief. Once issued, the reviewing 
official will immediately communicate the decision to each party.
    (c) Public notice and communications to the Drug Enforcement 
Administration (DEA). (1) If the suspension and proposed revocation of 
OTP certification are upheld, the revocation of certification will 
become effective immediately and the public will be notified by 
publication of a notice in the Federal Register. The Secretary will 
notify DEA within 5 days that the OTP's registration should be revoked.
    (2) If the suspension and proposed revocation of OTP certification 
are denied, the revocation will not take effect and the suspension will 
be lifted immediately. Public notice will be given by publication in 
the Federal Register. The Secretary will notify DEA within 5 days that 
the OTP's registration should be restored, if applicable.


Sec.  8.34  Court review of final administrative action; exhaustion of 
administrative remedies.

    Before any legal action is filed in court challenging the 
suspension, proposed revocation, or adverse action, respondent shall 
exhaust administrative remedies provided under this subpart, unless 
otherwise provided by Federal law. The reviewing official's decision, 
under Sec.  8.28(e) or Sec.  8.33(a), constitutes final agency action 
as of the date of the decision.

Subpart E [Reserved]

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-01693 Filed 1-31-24; 4:15 pm]
BILLING CODE 4162-20-P