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



[[Page 77329]]

Vol. 87

Friday,

No. 241

December 16, 2022

Part IV





Department of Health and Human Services





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42 CFR Part 8





Medications for the Treatment of Opioid Use Disorder; Proposed Rule

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

[[Page 77330]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

42 CFR Part 8

RIN 0930-AA39


Medications for the Treatment of Opioid Use Disorder

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

ACTION: Notice of proposed rulemaking.

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

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

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

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

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

FOR FURTHER INFORMATION CONTACT: Robert Baillieu, MD, MPH, Physician 
and Senior Advisor, SAMHSA/CSAT, 5600 Fishers Lane, Room 13-E-30, 
Rockville, MD 20857, Phone: 202-923-0996, Email: 
[email protected].

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

Executive Summary

A. Overview

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

[[Page 77331]]

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

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

C. Summary of Major Proposals

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

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[[Page 77332]]

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

[[Page 77333]]

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

[[Page 77334]]

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

Background and Need for Proposed Rule

    As of June 2022 there are over 1,920 OTPs in the United States, 
providing care to over 650,000 patients. These are the only settings 
within which methadone, a schedule II opioid receptor agonist, can be 
legally provided to people with OUD outside the context of hospital 
admission or certain other special circumstances.\14\
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    \14\ 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. Currently, these include methadone and buprenorphine, a 
schedule III partial opioid receptor agonist. Other pharmacotherapies, 
such as naltrexone, may be provided but are not subject to regulations 
under part 8. For purposes of certification, OTPs must also provide 
adequate medical, counseling, vocational, educational, and other 
assessment and treatment services either onsite or by referral to an 
outside agency or practitioner.\15\ Buprenorphine can also be dispensed 
(including by prescribing) to treat OUD by eligible practitioners with 
a waiver under 21 U.S.C. 823(g)(2) in settings outside of OTPs given 
its different scheduling and treatment under the Controlled Substances 
Act.\16\
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    \15\ Substance Abuse and Mental Health Services Administration. 
(2015). Federal guidelines for opioid treatment programs. HHS 
Publication No. (SMA) PEP15-FEDGUIDEOTP. Rockville, MD: Substance 
Abuse and Mental Health Services Administration.
    \16\ 21 U.S.C. 823(g)(2); Substance Abuse and Mental Health 
Services Administration. Medications for Opioid Use Disorder. 
Treatment Improvement Protocol (TIP) Series 63 Publication No. 
PEP21-02-01-002. Rockville, MD: Substance Abuse and Mental Health 
Services Administration, 2021.
---------------------------------------------------------------------------

    Practitioners treating OUD and the OTPs in which they practice must 
continuously adapt to evolving patterns of drug misuse. Over the past 
40 years, this has been complicated by rapid changes in prescribing 
practices, supply chains and patterns of drug use. Indeed, the early 
opioid epidemic of the 1990s was characterized by an increased supply 
of prescription opioids.\17\ By 2010, however, the U.S. began to see 
rapid increases in overdose deaths involving heroin \18\ and then by 
2013, synthetic opioids other than methadone--primarily illicitly 
manufactured fentanyl--contributed to a further rise in overdose-
related deaths.19 20
---------------------------------------------------------------------------

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

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

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

A. Regulatory Background

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

[[Page 77335]]

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

    \24\ For full text, see: https://www.ncbi.nlm.nih.gov/books/NBK232108/.
---------------------------------------------------------------------------

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

    \25\ See https://www.federalregister.gov/documents/2016/07/08/2016-16120/medication-assisted-treatment-for-opioid-use-disorders.
---------------------------------------------------------------------------

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

    \26\ SAMHSA treatment locator. See https://dpt2.samhsa.gov/treatment/directory.aspx.
---------------------------------------------------------------------------

Flexibility for Methadone Medication Take Homes in Opioid Treatment 
Programs

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

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

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

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

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

[[Page 77336]]

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

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

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

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

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

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

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

    \44\ See https://www.deadiversion.usdoj.gov/coronavirus.html.
---------------------------------------------------------------------------

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

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

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

[[Page 77337]]

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

    \47\ OTPs are authorized to dispense narcotic maintenance and 
detoxification medication under 21 U.S.C. 823(g)(1) and regulated 
under 42 CFR part 8.
    \48\ See https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
---------------------------------------------------------------------------

    Recent research has demonstrated that telehealth can be an 
effective tool in integrating care and extending the reach of specialty 
providers,\49\ and that among those requiring treatment with 
buprenorphine, there are high levels of satisfaction with the use of 
telehealth services.\50\ Additionally, there are no significant 
differences between telehealth and in-person buprenorphine induction in 
the rate of continued substance use, retention in treatment or 
engagement in services.38 51 Research also shows that there 
is no significant difference in client and provider ratings of 
therapeutic alliance when using telehealth technology platforms.\39\
---------------------------------------------------------------------------

    \49\ Guille, C., Simpson, A.N., Douglas, E., Boyars, L., 
Cristaldi, K., McElligott, J., Johnson, D., & Brady, K. (2020). 
Treatment of opioid use disorder in pregnant women via telemedicine: 
A nonrandomized controlled trial. JAMA Network Open, 3(1), e1920177-
e1920177.
    \50\ King, V.L., Brooner, R. K., Peirce, J.M., Kolodner, K., & 
Kidorf, M.S. (2014). A randomized trial of web-based 
videoconferencing for substance abuse counseling. Journal of 
Substance Abuse Treatment, 46(1), 36-42.
    \51\ Vakkalanka, J.P., Lund, B. C., Ward, M.M., Arndt, S., 
Field, R.W., Charlton, M., & Carnahan, R.M. (2022). Telehealth 
Utilization Is Associated with Lower Risk of Discontinuation of 
Buprenorphine: a Retrospective Cohort Study of US Veterans. Journal 
of general internal medicine, 37(7), 1610-1618. https://doi.org/10.1007/s11606-021-06969-1.
---------------------------------------------------------------------------

    In the face of an escalating overdose crisis and an increasing need 
to reach remote and underserved communities, making the buprenorphine 
telehealth flexibility permanent is of paramount importance. The 
proposed rule makes permanent criteria of initiation of buprenorphine 
via audio-only or audio-visual telehealth technology if an OTP 
physician, primary care physician, or an authorized healthcare 
professional under the supervision of a program physician, determines 
that an adequate evaluation of the patient can be accomplished via 
telehealth.
    SAMHSA believes that evidence underlying the initiation of 
buprenorphine using telehealth translates, to some degree, to the 
treatment of OUD with methadone, and warrants expanding access to 
methadone therapy by applying some of the buprenorphine in-person 
examination flexibilities to treatment with methadone in OTPs.\52\ The 
proposed rule allows for the use of audio-visual telehealth for any new 
patient who will be treated by the OTP with methadone if a program 
physician, or an authorized healthcare professional under the 
supervision of a program physician, determines that an adequate 
evaluation of the patient can be accomplished via an audio-visual 
telehealth platform. SAMHSA is not extending this change to the use of 
audio-only telehealth platforms in assessing new patients who will be 
treated with methadone because methadone, in comparison to 
buprenorphine, holds a higher risk profile for sedation in patients 
presenting with mild somnolence which may be easier to identify through 
an audio-visual telehealth platform. The proposed rule is not 
applicable to, and does not authorize, the prescription of methadone 
pursuant to a telehealth visit. Instead, this proposed change applies 
to the ordering of methadone by appropriately licensed OTP 
practitioners and dispensed to the individual patient by the OTP under 
existing OTP procedures.
---------------------------------------------------------------------------

    \52\ Chan B, Bougatsos C, Priest KC, McCarty D, Grusing S, Chou 
R. Opioid treatment programs, telemedicine and COVID-19: A scoping 
review. Subst Abus. 2022;43(1):539-546. doi: 10.1080/
08897077.2021.1967836. Epub 2021 Sep 14. PMID: 34520702.
---------------------------------------------------------------------------

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

Expanding Access to Services

    On June 28, 2021, the DEA introduced requirements for OTPs to add a 
``mobile component'' to their existing registration and waived any 
obligation for an OTP mobile medication unit complying with these 
requirements to separately register at the remote locations where it 
dispenses.\53\ On September 21, 2021, SAMHSA released guidance on the 
establishment of mobile and non-mobile medication units and allowable 
services.\54\ While part 8 currently allows OTPs certified by SAMHSA to 
establish medication units (as defined under 42 CFR 8.2), the proposed 
rule further defines mobile units and clarifies potential services, 
interventions and accreditation processes.
---------------------------------------------------------------------------

    \53\ See 86 FR 33861; https://www.federalregister.gov/documents/2021/06/28/2021-13519/registration-requirements-for-narcotic-treatment-programs-with-mobile-components.
    \54\ See https://www.samhsa.gov/medication-assisted-treatment/statutes-regulations-guidelines#mobile.
---------------------------------------------------------------------------

    Additionally, the proposed rule defines harm reduction and promotes 
expansion of harm reduction services to OTP patients.\55\ The 
importance of this has been highlighted during the COVID-19 pandemic, 
principally with the CDC and SAMHSA's April 7, 2021, joint announcement 
that Federal funding could be used to purchase rapid fentanyl test 
strips (FTS).\56\ This was proposed in an effort to help curb the 
dramatic spike in drug overdose deaths largely driven by the use (both 
intentional and unintentional) of potent synthetic opioids, primarily 
illicitly manufactured fentanyl. FTS can be used to determine if drugs 
have been mixed or cut with fentanyl, providing people who use drugs 
and their communities with important information about fentanyl in the 
illicit drug supply so they can take steps to reduce their risk of 
overdose. Other important harm reduction activities highlighted in the 
proposed rule include: counseling on preventing exposure to, and the 
transmission of, HIV, viral hepatitis, and STIs; providing access to 
services and treatments for those with HIV, viral hepatitis or an STI; 
provision of patient-centered harm reduction education; and 
distribution of opioid overdose reversal medications (e.g., 
naloxone).\57\
---------------------------------------------------------------------------

    \55\ The proposed rule does not permit OTPs to engage in any 
activities that would violate Federal, State, or local law.
    \56\ See https://www.cdc.gov/media/releases/2021/p0407-Fentanyl-Test-Strips.html.
    \57\ See https://www.samhsa.gov/blog/new-samhsa-guide-highlights-hiv-prevention-treatment-people-substance-use-andor-mental.
---------------------------------------------------------------------------

    The need to facilitate access to services has been highlighted 
during the COVID-19 pandemic. This is particularly important in the 
face of increased exposure to fentanyl. Section 8.12(e)(1) of the 
proposed rule eliminates the requirement that a person must have had an 
addiction to opioids for one year before admission to treatment and 
receipt of OTP services, and permits access to those: who meet 
diagnostic criteria for a moderate to severe OUD; individuals with 
active

[[Page 77338]]

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

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

A. Heading

    The Department proposes to revise the heading to Medications for 
the Treatment of Opioid Use Disorder to reflect current medical 
terminology and to remove stigmatizing language. The term `opioid use 
disorder' more precisely reflects the diagnosis for which medications 
are indicated. Further to this, the terms `maintenance' and 
`detoxification' reference outdated terminology that has potentially 
hindered adoption of evidence-based treatments for OUD.\59\ The amended 
heading reflects current medical terminology and highlights that OUD is 
a chronic, treatable condition.
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    \59\ NIDA. 2021, November 29. Words Matter--Terms to Use and 
Avoid When Talking About Addiction. Retrieved from 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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B. Subpart A

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

C. Section 8.1--Scope

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

[[Page 77339]]

the manner by which elements of other chronic disease care are 
described.
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    \60\ Substance Abuse and Mental Health Services Administration. 
Medications for Opioid Use Disorder. Treatment Improvement Protocol 
(TIP) Series 63 Publication No. PEP21-02-01-002. Rockville, MD: 
Substance Abuse and Mental Health Services Administration, 2021.
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D. Section 8.2--Definitions

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

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

F. Section 8.4--Accreditation Body Responsibilities

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

G. Section 8.11--Opioid Treatment Program Certification

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

[[Page 77340]]

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

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

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

[[Page 77341]]

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

[[Page 77342]]

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

I. Section 8.14--Suspension or Revocation of Certification

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

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

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

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

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

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

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

[[Page 77343]]

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

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

Public Participation

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

Regulatory Impact Analysis

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

Statement of Need

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

[[Page 77344]]

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

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

    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects; distributive impacts; and equity). Executive Order 13563 is 
supplemental to, and reaffirms the principles, structures, and 
definitions governing regulatory review as established in, Executive 
Order 12866.
    This proposed rule is partially regulatory and partially 
deregulatory. The Department estimates that because much of what is 
being proposed does not substantially alter current practice as 
implemented over the past 2 years under the COVID PHE, the proposed 
rule will not result in significantly altered costs. Further to this, 
the proposed rule creates efficiencies in service delivery and in 
administration. These include strengthening the patient-practitioner 
relationship in a manner that promotes efficient, evidence-based and 
patient-centered care, updating accreditation procedures and providing 
a stable regulatory environment. Additionally, the proposed rule makes 
permanent some OTP treatment flexibilities implemented within the past 
two years.

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

    A recent analysis by the Centers for Disease Control and Prevention 
(CDC) demonstrates high levels of overdose among Black, American Indian 
and Alaska Native communities over the course of the pandemic.\95\ 
While these trends existed long before the COVID-19 PHE, this study 
highlights that overdose death rates rose 44 percent in 2020 for Black 
people and 39 percent for American Indian and Alaska Native people, 
compared with 22 percent for white people.\95\ Black youth ages 15 to 
24 saw an 86 percent increase in overdose deaths, the largest spike of 
any age or race group, while Black men 65 and older were nearly seven 
times as likely than white men to die from an overdose.\95\ It was also 
found that Black people were less than half as likely as white people 
to have received substance use treatment.
---------------------------------------------------------------------------

    \95\ Kariisa M., Davis N.L., Kumar S., et al. Vital Signs: Drug 
Overdose Deaths, by Selected Sociodemographic and Social 
Determinants of Health Characteristics--25 States and the District 
of Columbia, 2019-2020. MMWR Morb Mortal Wkly Rep 2022;71:940-947. 
DOI: https://dx.doi.org/10.15585/mmwr.mm7129e2.
---------------------------------------------------------------------------

    This disparity amplifies the importance of promoting person-
centered care that is culturally appropriate and responsive to patient 
need, while also fostering a treatment environment that promotes and 
sustains patient engagement. The proposed changes facilitate the 
practitioner-patient relationship in a manner that espouses these 
principles, while also expanding the reach of OTPs (through activities 
such as mobile medication units) to physically engage communities that 
are in need of intervention. Further to this, the proposed changes 
promote examination of a patient's cultural needs as they engage in 
treatment services. This is consistent with evidence-based and 
culturally responsive paradigms of care.
    The proposed changes also facilitate patient engagement through 
removing, at the practitioner's discretion, the requirement to attend 
an OTP each day. Indeed, the ability to provide unsupervised doses of 
methadone early in treatment allows those with unstable access to 
transportation, for example, to focus on recovery activities in their 
own community. Evidence from the past two years demonstrates safety, as 
well as high patient and practitioner satisfaction with take-home doses 
of methadone. This is principally because unsupervised doses of 
methadone allow individuals the opportunity to engage in employment or 
other activities that are supportive of recovery and longer term 
community involvement.
1. Cost-Benefit Analysis
a. Overview
    The U.S. estimated economic cost of opioid use disorder ($471 
billion) and fatal opioid overdose ($550 billion), prior to the 
pandemic, totaled $1,021 billion.\96\ Among the 39 jurisdictions

[[Page 77345]]

reviewed in this analysis, combined costs of opioid use disorder and 
fatal opioid overdose varied from $985 million in Wyoming to $72.6 
billion in Ohio. Per capita combined costs varied from $1,204 in Hawaii 
to $7,247 in West Virginia. States with high per capita combined costs 
were located mainly in the Ohio Valley and New England. Across many 
studies, reduced quality of life is the largest component of the cost 
of opioid use disorder.\97\
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    \96\ Luo, F., Li, M., & Florence, C. (2021). State-Level 
Economic Costs of Opioid Use Disorder and Fatal Opioid Overdose--
United States, 2017. MMWR. Morbidity and mortality weekly report, 
70(15), 541-546. https://doi.org/10.15585/mmwr.mm7015a1.
    \97\ Mitchell, S.G., Gryczynski, J., Schwartz, R.P., Myers, 
C.P., O'Grady, K.E., Olsen, Y.K., & Jaffe, J.H. (2015). Changes in 
Quality of Life following Buprenorphine Treatment: Relationship with 
Treatment Retention and Illicit Opioid Use. Journal of psychoactive 
drugs, 47(2), 149-157. https://doi.org/10.1080/02791072.2015.1014948.
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    A recent study showed that in the absence of treatment, 42,717 
overdoses (4,132 fatal, 38,585 nonfatal) and 12,660 deaths were 
estimated to occur in a cohort of 100,000 patients over 5 years.\98\ An 
estimated reduction in overdoses was associated with methadone 
treatment (10.7%), buprenorphine or naltrexone treatment (22.0%), and 
medication treatment combined with psychotherapeutic interventions 
(range, 21.0%-31.4%).\98\ Estimated decreased deaths were associated 
with treatment with methadone (6%), buprenorphine or naltrexone 
(13.9%), and the combination of medications and psychotherapy (16.9%). 
When criminal justice costs were included, all forms of MOUD (with 
buprenorphine, methadone, and naltrexone) were associated with cost 
savings compared with no treatment, yielding savings of $25,000 to 
$105,000 in lifetime costs per person.
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    \98\ Fairley M., Humphreys K., Joyce V.R., et al. (2021). Cost-
effectiveness of Treatments for Opioid Use Disorder. JAMA 
Psychiatry. 2021;78(7):767-777. doi:10.1001/
jamapsychiatry.2021.0247.
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    McAdam-Marx et al. reported in 2010 that Medicaid beneficiaries 
with opioid use disorder, physical dependence on opioids, or poisoning 
had nearly triple the total medical costs adjusted for baseline sample 
characteristics compared to beneficiaries matched by age, gender, and 
state with no opioid misuse diagnosis ($23,556 vs. $8436; P < 
0.001).\99\ The opioid dependence/abuse group (using an older version 
of the Diagnostic and Statistical Manual of Mental Disorders) also had 
higher prevalence of comorbidities, such as psychiatric disorders, 
pain-related diagnoses, and other substance use conditions. While this 
study considered overall cost, it did not address medication costs in 
particular, or any impact treatment may have had on overall cost.
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    \99\ McAdam-Marx C., Roland C.L., Cleveland J., Oderda G.M. 
(2010). Costs of opioid abuse and misuse determined from a Medicaid 
database. J Pain Palliat Care Pharmacother. 2010 Mar;24(1):5-18. 
doi: 10.3109/15360280903544877. PMID: 20345194.
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    OTPs provide comprehensive interventions including medications, 
counseling and services designed to offer a whole-person approach to 
care and ameliorate social determinants of health that contribute to 
substance misuse. Numerous studies have demonstrated that treatment 
with pharmacotherapy and counseling services can reduce overall 
healthcare costs for patients with OUD.100 101 102 For 
example, a 2019 analysis demonstrated that a comprehensive approach to 
OUD treatment is associated with improved health and economic 
outcomes.\103\ This study assessed patients with OUD treated at a 
comprehensive primary care center (CCP) and other Maryland facilities 
in a large state Medicaid program, and demonstrated cost savings with a 
comprehensive approach to care. Compared to the non-CCP patient group 
(n = 867), the CCP group (n = 131) had a higher 6-month buprenorphine 
treatment retention rate (P < 0.001), fewer hospital stays in the 12-
month follow-up period (P = 0.005), and lower total cost (US$10,942 vs. 
$13,097, P < 0.001) and hospital stay cost (US$1448 vs. $4265, P = 
0.001).\103\ Other measures, including emergency department utilization 
and cost, substance use-related cost, and non-buprenorphine pharmacy 
cost, were not statistically different between the 2 groups. Results 
suggested that patients, as well as the health care system, can benefit 
from a comprehensive model of care for OUD with better treatment 
retention, fewer hospital stays, and lower costs.
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    \100\ Murphy S.M., Polsky D. (2016). Economic Evaluations of 
Opioid Use Disorder Interventions. Pharmacoeconomics. 2016 
Sep;34(9):863-87. doi: 10.1007/s40273-016-0400-5. PMID: 27002518; 
PMCID: PMC5572804.
    \101\ Baser O., Chalk M., Fiellin D.A., Gastfriend D.R. (2011). 
Cost and utilization outcomes of opioid-dependence treatments. Am J. 
Manag Care. 2011 Jun;17 Suppl 8:S235-48. PMID: 21761950.
    \102\ Lynch F.L., McCarty D., Mertens J., Perrin N.A., Green 
C.A., Parthasarathy S., Dickerson J.F., Anderson B.M., Pating D. 
(2014). Costs of care for persons with opioid dependence in 
commercial integrated health systems. Addict Sci Clin Pract. 2014 
Aug 14;9(1):16. doi: 10.1186/1940-0640-9-16. PMID: 25123823; PMCID: 
PMC4142137.
    \103\ Hsu Y.J., Marsteller J.A., Kachur S.G., Fingerhood M.I. 
(2019). Integration of Buprenorphine Treatment with Primary Care: 
Comparative Effectiveness on Retention, Utilization, and Cost. 
Idemudia, E.S., Olasupo, M.O., & Modibo, M.W. (2018). Stigma and 
chronic illness: A comparative study of people living with HIV and/
or AIDS and people living with hypertension in Limpopo Province, 
South Africa. Curationis, 41(1), e1-e5. https://doi.org/10.4102/curationis.v41i1.1879.
---------------------------------------------------------------------------

    These findings are consistent with a 2016 cross sectional study 
that evaluated medical claims for Vermont Medicaid beneficiaries with 
opioid dependence or addiction between 2008 and 2013. In their 
analysis, Mohlman and colleagues determined that medication combined 
with psychosocial counseling is associated with reduced general health 
care expenditures and utilization, such as inpatient hospital 
admissions and outpatient emergency department visits, for Medicaid 
beneficiaries with opioid misuse.\104\ Two prior studies assessed data 
from commercial health insurance claims on the overall health care 
costs and utilization rates for those using MOUD compared to those 
treated without MOUD.101 105 The first study found that over 
a five-year period, members on MOUD had 50% lower total annual health 
plan costs than those who had two or more visits to an addiction 
treatment setting and no treatment, and 62% lower than those with zero 
or one visit for addiction treatment and no intervention.\105\ The 
other study found that after a six-month period, those on MOUD had 
significantly lower overall annual health plan costs compared to those 
with no medication ($10,192 vs. $14,353; p-value < 0.0001).\101\ The 
difference was driven largely by lower inpatient services and non-
opioid-related outpatient services for the group receiving medication.
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    \104\ Mohlman M.K., Tanzman B., Finison K., Pinette M., Jones C. 
Impact of Medication-Assisted Treatment for Opioid Addiction on 
Medicaid Expenditures and Health Services Utilization Rates in 
Vermont. J Subst Abuse Treat. 2016 Aug; 67:9-14. doi: 10.1016/
j.jsat.2016.05.002. Epub 2016 May 9. PMID: 27296656.
    \105\ McCarty D., Perrin N.A., Green C.A., Polen M.R., Leo M.C., 
Lynch F. (2010). Methadone maintenance and the cost and utilization 
of health care among individuals dependent on opioids in a 
commercial health plan. Drug Alcohol Depend. 2010 Oct 1;111(3):235-
40. doi: 10.1016/j.drugalcdep.2010.04.018. PMID: 20627427; PMCID: 
PMC2950212.
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    The regulatory impact analysis (RIA) outlined below, relies on data 
provided to SAMHSA by OTP accreditation bodies for the year 2020-2021. 
Pursuant to 42 CFR part 8, accreditation bodies and OTPs are required 
to submit information to SAMHSA's Center for Substance Abuse Treatment 
(CSAT). The annualized burden of information collection for OTPs and 
accreditation bodies under the rule is set forth in the tables that 
follow.
    This proposed rule does not substantially alter reporting burden or 
accreditation activities. The total number of burden hours reported in

[[Page 77346]]

2020-2021 for accreditation body respondents was approximately 394.70 
hours. The total number of burden hours for OTP respondents during the 
same period was 1,868.95 hours. The annual burden associated with this 
rule and the associated forms was estimated to be 2,263.65 hours.
    This analysis quantifies a few limited categories of paperwork-
related costs, but there are more substantive actions (with associated 
costs and benefits) that would be necessary in the chain of cause and 
effect between the rule's most direct effects and the health and 
mortality consequences that are implied, above, as being potentially 
large if this proposal is finalized. For instance, relative to the 
appropriate analytic baseline (the future in the absence of the rule), 
the proposed rule would facilitate the expansion of mobile methadone 
units via their inclusion in operations, and such expansion would 
entail both new use of resources (costs \106\) and then, contingent 
upon such costs being incurred, the types of benefits described above. 
As a further example, the accrual of health and overdose-mortality-
avoidance benefits due to removal of the one-year requirement for 
opioid addiction before patient admission to an OTP would generally be 
contingent upon increasing resource use associated with such admission.
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    \106\ It would be incorrect to interpret this analytic 
discussion as implying that the proposed rule changes authorization 
procedures for mobile methadone units.
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b. Estimated Costs of Reporting Burdens for OTPs and Accreditation 
Bodies
    In developing its estimates of the potential costs of the proposed 
regulation, the Department relied substantially on recent estimates of 
burden and cost pertaining to requirements set forth in 42 CFR part 8.
    Hourly labor costs involved in reporting requirements vary greatly 
between programs. Based on wage estimates obtained from the U.S. 
Department of Labor, Bureau of Labor Statistics, and Occupational 
Employment Statistics website, it is estimated that employees involved 
in complying with reporting requirements range from minimum wage 
($7.25) clerical workers, to counselors averaging $22.14 an hour, 
managers, licensed practical nurses and registered nurses averaging 
$35.36 per hour, administrators averaging $52.58 per hour, and 
physicians averaging $96.26 per hour. The estimated average hourly wage 
for program personnel involved in reporting requirements, calculated as 
a simple mean, is $42.71. Multiplying the estimated average hourly wage 
by 2.0 to account for fringe benefits and overhead costs, an estimated 
hourly labor cost of $85.42 is obtained. The cost to accreditation 
bodies for applying for initial and ongoing approval with Form SMA-163, 
as well as for complying with the reporting requirements under 42 CFR 
8.4 and 8.6 may be estimated at $33,672.56, using the $85.42 hourly 
cost figure. The estimated total annualized cost to the treatment 
program respondents for preparing the Form SMA-162 and for complying 
with other reporting requirements pursuant to 42 CFR 8.11, 8.24, 8.25, 
8.26, and 8.28, using $85.42 as the hourly cost figure, is $16,140.11.

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

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

[[Page 77347]]

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

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

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

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

B. Regulatory Flexibility Act

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

[[Page 77348]]

proposed rule would not result in a significant negative impact.

C. Unfunded Mandates Reform Act

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

D. Executive Order 13132--Federalism

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

E. Assessment of Federal Regulation and Policies on Families

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

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

F. Paperwork Reduction Act of 1995

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

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


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

[[Page 77349]]

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

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

List of Subjects in 42 CFR Part 8

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


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

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

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

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

Subpart A--General Provisions


Sec.  8.1  Scope.

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

[[Page 77350]]

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


Sec.  8.2  Definitions.

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

[[Page 77351]]

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

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

Subpart B--Accreditation of Opioid Treatment Programs


Sec.  8.3  Application for approval as an accreditation body.

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

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


Sec.  8.4  Accreditation body responsibilities.

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

[[Page 77354]]

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.
    (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

[[Page 77355]]

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(g)(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 who 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 1 year unless the Secretary determines 
that such conditional certification would adversely affect patient 
health. An OTP must obtain a standard 3-year accreditation, 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 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;

[[Page 77356]]

    (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 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. Federal agencies 
operating OTPs have agreed to cooperate voluntarily with State agencies 
by granting permission on an informal basis for designated State 
representatives to visit Federal OTPs and by furnishing a copy of 
Federal reports to the State authority, including the reports required 
under this section.
    (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 or Substance Abuse and Mental Health Services 
Administration (SAMHSA), by accreditation bodies, by the DEA, and by 
authorized employees of any relevant State or Federal governmental 
authority.
    (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) A treatment program 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.
    (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 a 
public or nonprofit private OTP may provide interim treatment, the 
program 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 public or nonprofit private 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, which is 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 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.

[[Page 77357]]

    (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 will not be required 
for the continuous medication treatment or withdrawal management of a 
patient who is admitted to a hospital or long-term care facility for 
the treatment of medical conditions other than OUD and who requires 
medication continuity or withdrawal management during the period of 
their stay in that long-term care facility when such treatment is 
permitted under applicable Federal law. The term ``long-term care 
facility'' is defined in Sec.  8.2. Nothing in this section is intended 
to relieve long-term care facilities from the obligation to obtain 
registration from the Attorney General, as appropriate, under section 
303(g) of the Controlled Substances Act.


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 qualifying 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 qualifying 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.
    (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, such as a pregnancy test, 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 with either

[[Page 77358]]

buprenorphine or methadone, if a qualified 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.
    (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.
    (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. OTPs must provide 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 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.
    (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

[[Page 77359]]

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 a program, the initial dose 
of methadone shall be individually determined, and is not to exceed 30 
milligrams, and the total dose for the first day shall not exceed 40 
milligrams. Should this not be sufficient to suppress symptoms of 
withdrawal, the OTP practitioner licensed under the appropriate State 
law and registered under the appropriate State and Federal laws to 
administer or dispense MOUD, must document in the patient's record a 
specific rationale indicating that 40 milligrams did not adequately 
suppress opioid withdrawal symptoms, and that a higher dose was 
clinically indicated and thus provided to the patient.
    (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) Treatment program 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.
    (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 a public or 
nonprofit, private 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

[[Page 77360]]

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 in this section 
apply to interim treatment with the following exceptions:
    (i) A primary counselor is not required to be assigned to the 
patient, but crisis services 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, and 
educational 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 guilty of 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, DEA Inspector, State Inspector, or accreditation body 
representative for permission to inspect the program or the program's 
operations or its records.
    (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 
and shall state that the OTP may seek review of the action in 
accordance with the procedures in this subpart.
    (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;

[[Page 77361]]

    (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 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 an opportunity for a 
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 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 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 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 
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

[[Page 77362]]

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, 
either of which will be made a part of the record.
    (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 and the transcript shall be made a part of the 
record. 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 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) through (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.

    Except for routine administrative and procedural matters, 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

[[Page 77363]]

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 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]

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


Sec.  8.610  Practitioner eligibility requirements for a 3-year 275-
patient limit.

    The total number of patients that a practitioner may dispense or 
prescribe covered medications to at any one time for purposes of 21 
U.S.C. 823(g)(2)(B)(iii) is 275 if:
    (a) The practitioner possesses a current waiver to treat up to 100 
patients with OUD under section 303(g)(2) of the Controlled Substances 
Act (21 U.S.C. 823(g)(2)) and has maintained the waiver in accordance 
with applicable statutory requirements without interruption for at 
least one year since the practitioner's notification of intent (NOI) 
under section 303(g)(2)(B) to treat up to 100 patients was approved;
    (b) The practitioner:
    (1) Holds additional credentialing as defined in Sec.  8.2; or
    (2) Provides OUD treatment utilizing covered medications in a 
qualified practice setting as defined in Sec.  8.615;
    (c) The practitioner has not had his or her enrollment and billing 
privileges in the Medicare program revoked under Sec.  424.535 of this 
title; and
    (d) The practitioner has not been found to have violated the 
Controlled Substances Act pursuant to 21 U.S.C. 824(a).


Sec.  8.615  Definition of a qualified practice setting.

    A qualified practice setting is a practice setting that:
    (a) Provides professional coverage for patient medical emergencies 
during hours when the practitioner's practice is closed;
    (b) Provides access to case-management services for patients 
including referral and follow-up services for programs that provide, or 
financially support, the provision of services such as physical, 
behavioral, social, housing, employment, educational, or other related 
services;
    (c) Uses health information technology (health IT) systems such as 
electronic health records, if otherwise required to use these systems 
in the practice setting. Health IT means the electronic systems that 
health care professionals and patients use to store, share, and analyze 
health information;
    (d) Is registered for their State prescription drug monitoring 
program (PDMP) where operational and in accordance with Federal and 
State law. PDMP means a statewide electronic database that collects 
designated data on controlled medications dispensed in the State. For 
practitioners providing care in their capacity as employees or 
contractors of a Federal Government agency, participation in a PDMP is 
required only when such participation is not restricted based on their 
State of licensure and is in accordance with Federal statutes and 
regulations; and
    (e) Accepts third-party payment for costs in providing health 
services, including written billing, credit, and collection policies 
and procedures, or Federal health benefits.


Sec.  8.620  Applying for a 275-patient limit.

    In order for a practitioner to receive approval for a 3-year 
patient limit of 275, a practitioner must meet all of the requirements 
specified in Sec.  8.610 and submit a Request for Patient Limit 
Increase to the Secretary that includes all of the following:

[[Page 77364]]

    (a) Completed Request for Patient Limit Increase form;
    (b) Statement certifying that the practitioner:
    (1) Will adhere to nationally recognized evidence-based guidelines 
for the treatment of patients with OUD;
    (2) Will provide patients with necessary behavioral health services 
as defined in Sec.  8.2 or through an established formal agreement with 
another entity to provide behavioral health services;
    (3) Will provide appropriate releases of information, in accordance 
with Federal and State laws and regulations, including the Health 
Information Portability and Accountability Act Privacy Rule (45 CFR 
part 160 and 45 CFR part 164, subparts A and E) and 42 CFR part 2, if 
applicable, to permit the coordination of care with behavioral health, 
medical, and other service practitioners;
    (4) Will use patient data to inform the improvement of outcomes;
    (5) Will adhere to a diversion control plan to manage the covered 
medications and reduce the possibility of diversion of covered 
medications from prescribed treatment use;
    (6) Has considered how to assure continuous access to care in the 
event of practitioner incapacity or an emergency-situation that would 
impact a patient's access to care as defined in Sec.  8.2; and
    (7) Will notify all patients above the 100-patient level, in the 
event that the request for the higher patient limit is not renewed or 
the renewal request is denied, that the practitioner will no longer be 
able to provide buprenorphine treatment to them and make every effort 
to transfer patients to other treatment providers; and
    (c) Any additional documentation to demonstrate compliance with 
Sec.  8.610 as requested by the Secretary.


Sec.  8.625  Processing a 275 Request for Patient Limit Increase.

    (a) Not later than 45 days after the date on which the Secretary 
receives a practitioner's Request for Patient Limit Increase as 
described in Sec.  8.620, or renewal Request for Patient Limit Increase 
as described in Sec.  8.640, the Secretary shall approve or deny the 
request.
    (1) A practitioner's Request for Patient Limit Increase will be 
approved if the practitioner satisfies all applicable requirements 
under Sec. Sec.  8.610 and 8.620. The Secretary will thereafter notify 
the practitioner who requested the patient limit increase, and the DEA, 
that the practitioner has been approved to treat up to 275 patients 
using covered medications. A practitioner's approval to treat up to 275 
patients under this section will extend for a term not to exceed 3 
years.
    (2) The Secretary may deny a practitioner's Request for Patient 
Limit Increase if the Secretary determines that:
    (i) The Request for Patient Limit Increase is deficient in any 
respect; or
    (ii) The practitioner has knowingly submitted false statements or 
made misrepresentations of fact in the practitioner's Request for 
Patient Limit Increase.
    (b) If the Secretary denies a practitioner's Request for Patient 
Limit Increase (or renewal), the Secretary shall notify the 
practitioner of the reasons for the denial.
    (c) If the Secretary denies a practitioner's Request for Patient 
Limit Increase (or renewal) based solely on deficiencies that can be 
resolved, and the deficiencies are resolved to the satisfaction of the 
Secretary in a manner and time period approved by the Secretary, the 
practitioner's Request for Patient Limit Increase will be approved. If 
the deficiencies have not been resolved to the satisfaction of the 
Secretary within the designated time period, the Request for Patient 
Limit Increase may be denied.


Sec.  8.630  Practitioner requirements to maintain a 275-patient limit.

    A practitioner whose Request for Patient Limit Increase is approved 
in accordance with Sec.  8.625 shall maintain all eligibility 
requirements specified in Sec.  8.610, and all attestations made in 
accordance with Sec.  8.620(b), during the practitioner's 3-year 
approval term. Failure to do so may result in the Secretary withdrawing 
its approval of a practitioner's Request for Patient Limit Increase.


Sec.  8.640  Renewal process for a 3-year 275 Request for Patient Limit 
Increase.

    (a) Practitioners who intend to continue to treat up to 275 
patients beyond their current 3-year approval term must submit a 
renewal Request for Patient Limit Increase in accordance with the 
procedures outlined under Sec.  8.620 no more than 30 days before the 
expiration of their current approval term.
    (b) If the Secretary does not reach a final decision on a renewal 
Request for Patient Limit Increase before the expiration of a 
practitioner's approval term, the practitioner's existing approval term 
will be deemed extended until the Secretary reaches a final decision.


Sec.  8.645  Practitioner responsibility when no renewal request for 
patient limit increase is submitted, or whose renewal request is 
denied.

    Practitioners who are approved to treat up to 275 patients in 
accordance with Sec.  8.625, but who do not renew their Request for 
Patient Limit Increase, or whose renewal request is denied, shall 
notify, under Sec.  8.620(b)(7) in a time period specified by the 
Secretary, all patients affected above the 100-patient limit, that the 
practitioner will no longer be able to provide OUD treatment services 
using covered medications and make every effort to transfer patients to 
other treatment providers.


Sec.  8.650  Suspension or revocation of the Secretary's approval of a 
practitioner's request for patient limit increase.

    The Secretary, at any time during a practitioner's 3-year approval 
term, may suspend or revoke its approval of a practitioner's Request 
for Patient Limit Increase under Sec.  8.625 if it is determined that:
    (a) Immediate action is necessary to protect public health or 
safety;
    (b) The practitioner made misrepresentations in the practitioner's 
Request for Patient Limit Increase;
    (c) The practitioner no longer satisfies the requirements of this 
subpart; or
    (d) The practitioner has been found to have violated the CSA 
pursuant to 21 U.S.C. 824(a).


Sec.  8.655  Temporary increase to treat up to 275 patients in 
emergency situations.

    (a) Practitioners with a current waiver to prescribe up to 100 
patients and who are not otherwise eligible to treat up to 275 patients 
under Sec.  8.610 may request a temporary increase of 6-months to treat 
up to 275 patients in order to address emergency situations as defined 
in Sec.  8.2. Practitioners may not be granted more than 2 consecutive 
emergency 275-patient limit requests. To apply for a 6-month emergency 
275-patient limit, the practitioner must provide information and 
documentation that:
    (1) Describes the emergency situation in sufficient detail so as to 
allow a determination to be made regarding whether the situation 
qualifies as an emergency situation as defined in Sec.  8.2, and that 
provides a justification for an immediate increase in that 
practitioner's patient limit;
    (2) Identifies a period of time, not longer than 6 months, in which 
the higher patient limit should apply, and provides a rationale for the 
period of time requested; and
    (3) Describes an explicit and feasible plan to meet the public and 
individual

[[Page 77365]]

health needs of the impacted persons once the practitioner's approval 
to treat up to 275 patients expires.
    (b) Prior to taking action on a practitioner's request under this 
section, the Secretary shall consult, to the extent practicable, with 
the appropriate governmental authorities in order to determine whether 
the emergency situation that a practitioner describes justifies an 
immediate increase in the higher patient limit.
    (c) If the Secretary determines that a practitioner's request under 
this section should be granted, the Secretary will notify the 
practitioner that his or her request has been approved. The period of 
such approval shall not exceed six months.
    (d) If practitioners wish to receive an extension of the approval 
period granted under this section, they must submit a request to the 
Secretary at least 30 days before the expiration of the six-month 
period and certify that the emergency situation as defined in Sec.  8.2 
necessitating an increased patient limit continues. Prior to taking 
action on a practitioner's extension request under this section, the 
Secretary shall consult, to the extent practicable, with the 
appropriate governmental authorities in order to determine whether the 
emergency situation that a practitioner describes justifies an 
extension of an increase in the higher patient limit.
    (e) Except as provided in this section and Sec.  8.650, 
requirements in other sections under this subpart do not apply to 
practitioners receiving waivers in this section.

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-27193 Filed 12-13-22; 8:45 am]
BILLING CODE P