Medications for the Treatment of Opioid Use Disorder, 7528-7563 [2024-01693]
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Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations
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
Substance Abuse and Mental
Health Services Administration
(SAMHSA), Department of Health and
Human Services (‘‘HHS’’ or ‘‘the
Department’’).
ACTION: Final rule.
AGENCY:
This final rule modifies and
updates certain provisions of
regulations related to Opioid Treatment
Program (OTP) accreditation,
certification, and standards for the
treatment of Opioid Use Disorder (OUD)
with Medications for Opioid Use
Disorder (MOUD) in OTPs. This
includes making flexibilities put forth
during the COVID–19 Public Health
Emergency (PHE) permanent, as well as
expanding access to care and evidencebased treatment for OUD. The final rule
also removes all language and rules
pertaining to the Drug Addiction and
Treatment Act (DATA) Waiver from the
regulations pursuant to the
‘‘Consolidated Appropriations Act,
2023’’.
SUMMARY:
The effective date of this final
rule is April 2, 2024, and the
compliance date is October 2, 2024.
FOR FURTHER INFORMATION CONTACT:
Robert Baillieu, MD, MPH, Physician
and Senior Advisor, SAMHSA/CSAT,
5600 Fishers Lane, Room 13–E–30,
Rockville, MD, 20857, Phone: 202–923–
0996, Email: Robert.Baillieu@samhsa.
hhs.gov.
DATES:
The
discussion below includes an Executive
Summary and overview describing the
rule, responses to public comments, an
impact statement, and other required
regulatory analyses.
SUPPLEMENTARY INFORMATION:
Executive Summary
1 See
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21 U.S.C. 823(h)(1)–(3).
readability, the Department refers to specific
sections of 42 CFR part 8 using a shortened citation
with the ‘‘§ ’’ symbol except where necessary to
distinguish title 42 citations from other CFR titles,
such as title 45 CFR, and in footnotes where the full
reference is used.
3 See 42 CFR 8.1
4 The terms ‘‘narcotic drugs’’ and ‘‘detoxification
treatment’’ included in this paragraph are found in
statute. SAMHSA recognizes that these terms can be
stigmatizing for some people, and not aligned with
current terminology. SAMHSA uses ‘‘opioid agonist
medications’’ (see Treatment Improvement Protocol
(TIP) 63) as an alternative to ‘‘narcotic drugs’’ and
‘‘withdrawal management’’ as the alternative to
‘‘detoxification treatment’’.
2 For
A. Overview
This regulation finalizes the
Department’s proposed rule concerning
Medications for the Treatment of Opioid
Use Disorder published in the Federal
Register on December 16, 2022 (87 FR
77330). It also finalizes proposals found
in the Department’s supplemental
notice of proposed rulemaking
concerning removal of the DATA–2000
Waiver requirements issued in the
Federal Register on February 13, 2023
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(88 FR 9221). The final rule makes
changes to the Department’s existing
regulations concerning OTPs at 42 CFR
part 8.
The Controlled Substances Act (CSA),
under 21 U.S.C. 823(h)(1)-(3), provides
that ‘‘[t]he Attorney General shall
register an applicant to dispense
narcotic drugs to individuals for
maintenance treatment or detoxification
treatment (or both)’’ if, among other
things, the applicant ‘‘is determined by
the Secretary to be qualified (under
standards established by the Secretary
[of HHS]) to engage in the treatment
with respect to which registration is
sought[,]’’ and ‘‘if the Secretary
determines that the applicant will
comply with standards established by
the Secretary (after consultation with
the Attorney General) respecting the
quantities of narcotic drugs which may
be provided for unsupervised use by
individuals in such treatment.’’ 1 The
Secretary’s standards authorized under
section 823(h) have been published as
regulations under part 8 of title 42 of the
Code of Federal Regulations (‘‘42 CFR
part 8’’ or ‘‘part 8’’).2 Among other
things, these regulations establish the
procedures by which the Secretary of
HHS determines whether a program is
qualified to dispense opioid agonist
medications in the treatment of opioid
use disorders, and standards regarding
the appropriate quantities of opioid
agonist medications that may be
provided for unsupervised use by
individuals undergoing such treatment.3
In addition, ‘‘a program or practitioner
engaged in opioid treatment of
individuals with an opioid agonist
treatment medication’’ that is also
‘‘registered under 21 U.S.C. 823(h)(1)’’ is
described as an ‘‘Opioid Treatment
Program’’ (OTP).4
On December 29, 2022, the
‘Consolidated Appropriations Act, 2023’
(Pub. L. No: 117–328) was enacted,
resulting in the removal of requirements
to obtain a waiver from the registration
requirements of 21 U.S.C. 823(h)(1) for
qualifying practitioners seeking to
dispense or prescribe schedule III, IV, or
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V controlled substances that are FDAapproved for use in ‘‘maintenance and
detoxification treatment.’’ Practitioners
with a waiver under section 823(h)(2)
were limited in the number of patients
with OUD they may treat at any one
time, and depending on the
practitioner’s experience or
qualifications, this statutory limitation
was set at either 30, 100, or 275.5 The
Secretary was also authorized to change
the patient limitations by regulation,
and qualifying practitioners had to
satisfy the requirements of 42 CFR 8.610
through 8.655 ‘‘(or successor
regulations)’’ in order to treat up to 275
patients, which was the maximum
number under the law.6
In this final rule, the Department
modifies certain provisions of part 8 to
update OTP accreditation and
certification standards, as well as
treatment standards for the provision of
medications for opioid use disorder
(MOUD) as dispensed by OTPs.
Pursuant to the ‘Consolidated
Appropriations Act, 2023’ (Pub. L. No:
117–328), the final rule also removes
language pertaining to requirements for
individual practitioners to dispense
(including by prescribing) certain types
of MOUD with a waiver under 21 U.S.C.
823(h)(2). SAMHSA has developed this
final rule in consultation with the Drug
Enforcement Administration.
The final rule draws on experience
from the COVID–19 Public Health
Emergency (PHE), as well as more than
20 years of practice-based research. The
COVID–19 PHE necessitated changes to
policy guidance and legal exemptions to
protect the public’s health, promote
physical distancing and to preserve
patient and OTP staff safety. In March
2020, SAMHSA published guidance
regarding flexibilities that could be
leveraged in the provision of
unsupervised doses of methadone and
the use of telehealth when initiating
buprenorphine.7 These flexibilities
represented the first substantial change
to OTP treatment and medication
delivery standards in more than 20
years, and their role in facilitating
access to treatment is supported by
research.
This final rule not only makes these
COVID–19-related flexibilities
permanent, but also updates standards
5 Formally
under 21 U.S.C. 823(h)(2)(B)(iii)
under 21 U.S.C.
823(h)(2)(B)(iii)(II)(dd). See https://www.govinfo.
gov/content/pkg/USCODE-2016-title21/html/
USCODE-2016-title21-chap13-subchapI-partCsec823.htm.
7 See https://www.samhsa.gov/sites/default/files/
otp-guidance-20200316.pdf and https://
www.samhsa.gov/sites/default/files/faqs-for-oudprescribing-and-dispensing.pdf.
6 Formally
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to reflect an accreditation and treatment
environment that has evolved since part
8 went into effect in 2001. Accordingly,
the Department is updating part 8 to
promote practitioner autonomy; remove
discriminatory or outdated language;
create a patient-centered perspective;
and reduce barriers to receiving care.
These elements have been identified in
the literature and in feedback as being
essential to promoting effective
treatment in OTPs.8 9 10
To this end, the definition of a
practitioner has been modified to refer
to a provider who is appropriately
licensed by the State to prescribe
(including dispense) medications.
Admission criteria have been updated,
as required by section 1252(b) of the
‘Consolidated Appropriations Act,
2023’, to remove significant barriers to
entry, such as the one-year requirement
for opioid use disorder (OUD),11 while
also defining the scope and purpose of
the ‘initial’ and ‘periodic’ medical
examinations. The final rule also
includes new definitions to expand
access to evidence-based practices such
as split dosing, telehealth and harm
reduction activities. In addition,
outdated terms such as ‘detoxification’
have been revised to remove
stigmatizing language.
The Department promotes practitioner
autonomy and individualized care by
finalizing the provision containing the
criteria for unsupervised doses of
methadone. This includes removal from
sole consideration the length of time an
individual has been in treatment and
requirements for rigid reliance on
toxicology testing results that
demonstrate complete and sustained
abstinence from all substances prone to
misuse. Based on the clinical judgment
of the treating provider, patients may be
8 Suen LW, Coe WH, Wyatt JP, Adams ZM,
Gandhi M, Batchelor HM, Castellanos S, Joshi N,
Satterwhite S, Pe´rez-Rodrı´guez R, Rodrı´guez-Guerra
E, Albizu-Garcia CE, Knight KR, Jordan A.
Structural Adaptations to Methadone Maintenance
Treatment and Take-Home Dosing for Opioid Use
Disorder in the Era of COVID–19. Am J Public
Health. 2022 Apr;112(S2):S112–S116. doi: 10.2105/
AJPH.2021.306654. PMID: 35349324; PMCID:
PMC8965183.
9 Kleinman MB, Felton JW, Johnson A, Magidson
JF. ‘‘I have to be around people that are doing what
I’m doing’’: The importance of expanding the peer
recovery coach role in treatment of opioid use
disorder in the face of COVID–19 health disparities.
J Subst Abuse Treat. 2021 Mar;122:108182. doi:
10.1016/j.jsat.2020.108182. Epub 2020 Oct 21.
PMID: 33160763; PMCID: PMC7577312.
10 Suen LW, Castellanos S, Joshi N, Satterwhite S,
Knight KR. ‘‘The idea is to help people achieve
greater success and liberty’’: A qualitative study of
expanded methadone take-home access in opioid
use disorder treatment. Subst Abus.
2022;43(1):1143–1150. doi: 10.1080/
08897077.2022.2060438. PMID: 35499469.
11 See 42 CFR 8.12(e)(1).
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eligible for unsupervised, take-home
doses of methadone upon entry into
treatment. This change recognizes the
importance of the practitioner-patient
relationship and is consistent with
modern substance use disorder
treatment standards.12 It also allows for
greater flexibility in creating plans of
care that promote recovery activities
such as employment or education, while
also eliminating the barrier of frequent
OTP visits for individuals without
access to reliable transportation.13
Accreditation and certification
standards have been updated to codify
the use of online/electronic forms, and
to reflect a modern treatment
environment. Part 8 has also been
updated to facilitate information sharing
between Accreditation Bodies and
SAMHSA, particularly in those
circumstances where there have been
changes or violations in accreditation.
The final rule also clarifies
administrative issues pertaining to
accreditation, mobile medication units
and interim treatment.
This final rule makes treatment in
OTPs more accessible to patients, while
also supporting evidence-based and
patient-centered care. In creating these
changes, SAMHSA has relied on
published evidence, stakeholder
feedback, public comments to the
proposed rule and the need to expand
access to care in the face of a growing
overdose epidemic, exacerbated by the
COVID–19 pandemic.14 This is brought
further into focus by the HHS
declaration of a public health
emergency for the opioid crisis which
has been renewed regularly since
2017.15 While the COVID–19 public
health emergency expired as of May 11,
2023,16 the lessons learned from the
12 Substance Abuse and Mental Health Services
Administration. Medications for Opioid Use
Disorder. Treatment Improvement Protocol (TIP)
Series 63 Publication No. PEP21–02–01–002.
Rockville, MD: Substance Abuse and Mental Health
Services Administration, 2021.
13 Ware OD, Frey JJ, Cloeren M, Mosby A,
Imboden R, Bazell AT, Huffman M, Hochheimer M,
Greenblatt AD, Sherman SA. Examining
Employment and Employment Barriers Among a
Sample of Patients in Medication-Assisted
Treatment in the United States, Addictive Disorders
& Their Treatment: December 2021—Volume 20—
Issue 4—p 578–586 doi: 10.1097/
ADT.0000000000000295.
14 Tanz LJ, Dinwiddie AT, Snodgrass S,
O’Donnell J, Mattson CL, Davis NL. A qualitative
assessment of circumstances surrounding drug
overdose deaths during the early stages of the
COVID–19 pandemic. SUDORS Data Brief, No 2.
Atlanta, GA: Centers for Disease Control and
Prevention, U.S. Department of Health and Human
Services; 2022.
15 See https://www.phe.gov/emergency/news/
healthactions/phe/Pages/default.aspx.
16 See https://www.hhs.gov/about/news/2023/05/
09/fact-sheet-end-of-the-covid-19-public-healthemergency.html
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COVID–19 pandemic remain relevant
for ensuring access to safe and effective
substance use disorder treatment. The
changes created by this final rule are
expansive but are focused on
permanently implementing the existing
flexibilities and updating policies and
practices that are based on evidence. In
this way, SAMHSA believes that much
of what is contained in the rule will not
represent a significant burden for OTPs
and, in fact, will reduce burdens and
confer many benefits to providers and
patients. The final rule, therefore,
supports OTPs in their on-going
provision of equitable and evidencebased care to often marginalized
patients with OUD. The final rule also
is consistent with the HHS Overdose
Prevention Strategy and the National
Drug Control Strategy, both of which
call for increasing access to and the
uptake of evidence-based treatments for
substance use disorders.17
B. Background
As of June 2023, there are over 2,000
OTPs in the United States, providing
care to over 650,000 patients.18 These
are the only settings within which
methadone, a schedule II opioid
receptor agonist, can be legally provided
to patients with OUD outside the
context of hospital admission or certain
other special circumstances.19
An OTP is an accredited treatment
program with SAMHSA certification
and Drug Enforcement Administration
(DEA) registration to administer and
dispense opioid agonist medications
that are approved by FDA to treat OUD.
Such medications include methadone,
buprenorphine, a schedule III partial
opioid receptor agonist, and naltrexone
which is an opioid receptor antagonist.
For purposes of certification, OTPs must
also offer adequate medical, counseling,
vocational, educational, as well as other
assessment and treatment services either
onsite or by referral to an outside entity
or practitioner.20
Practitioners treating OUD and the
OTPs in which they practice must
continuously adapt to evolving patterns
of drug misuse. This is increasingly
17 See https://www.hhs.gov/overdose-prevention/.
See also https://www.whitehouse.gov/briefingroom/statements-releases/2022/04/21/fact-sheetwhite-house-releases-2022-national-drug-controlstrategy-that-outlines-comprehensive-path-forwardto-address-addiction-and-the-overdose-epidemic/
18 Data from the U.S. Department of Health and
Human Services, Treatment Locator, at https://
findtreatment.gov/
19 See 21 CFR 1306.07.
20 Substance Abuse and Mental Health Services
Administration. (2015). Federal guidelines for
opioid treatment programs. HHS Publication No.
(SMA) PEP15–FEDGUIDEOTP. Rockville, MD:
Substance Abuse and Mental Health Services
Administration.
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complicated by changes in controlled
medication prescribing practices,
supply chains and patterns of drug use.
Indeed, the early opioid epidemic of the
1990s was characterized by an increased
supply of prescription opioids.21 By
2010, however, the U.S. began to see
rapid increases in overdose deaths
involving heroin 22 and then by 2013,
synthetic opioids other than
methadone—primarily illicitly
manufactured fentanyl—contributed to
a further rise in overdose-related
deaths.23 24 The introduction of xylazine
into the illicit drug supply and its
associated harms further adds to an
evolving, complex, and dangerous
situation.25
The isolation, anxiety and reduced
access to resources experienced by
many during the COVID–19 pandemic
has exacerbated substance misuse and
overdose deaths. According to
provisional data from the Centers for
Disease Control and Prevention (CDC), a
predicted 109,940 Americans died from
a drug overdose in the 12-month period
ending in January 2023.26 Synthetic
opioids (primarily illicitly
manufactured fentanyl) appear to be the
principal driver of overdose deaths,
increasing 55 percent from 2019 to 2020
and further increasing 26 percent from
2020 to 2021.27 Overdose deaths
involving cocaine also increased by 22
percent from 2019 to 2020. These deaths
are likely linked to co-use or mixing (by
illicit producers) of cocaine with
illicitly manufactured fentanyl or
heroin.28 The rise in fentanyl use or
exposure, concurrent substance misuse,
as well as overdose deaths, necessitates
21 Centers for Disease Control and Prevention
(CDC). Vital signs: overdoses of prescription opioid
pain relievers—United States, 1999–2008. MMWR
MorbMortal Wkly Rep. 2011 Nov 4; 60(43):1487–
1492.
22 Rudd RA, Paulozzi LJ, Bauer MJ, Burleson RW,
Carlson RE, Dao D, Davis JW, Dudek J, Eichler BA,
Fernandes JC, Fondario A. Increases in heroin
overdose deaths—28 states, 2010 to 2012.MMWR
MorbMortal Wkly Rep. 2014 Oct 3; 63(39):849.
23 Gladden RM, Martinez P, Seth P. Fentanyl law
enforcement submissions and increases in synthetic
opioid-involved overdose deaths—27 states, 2013–
2014. MMWR MorbMortal Wkly Rep. 2016; 65:837–
43.
24 O’Donnell JK, Gladden RM, Seth P. Trends in
deaths involving heroin and synthetic opioids
excluding methadone, and law enforcement drug
product reports, by census region—United States,
2006–2015. MMWR MorbMortal Wkly Rep. 2017;
66:897–903.
25 See https://www.samhsa.gov/sites/default/files/
colleague-letter-xylazine.pdf.
26 Ahmad FB, Cisewski JA, Rossen LM, Sutton P.
Provisional drug overdose death counts. National
Center for Health Statistics. 2023.
27 Wide-ranging online data for epidemiologic
research (WONDER). Atlanta, GA: CDC, National
Center for Health Statistics; 2023. Available at
https://wonder.cdc.gov.
28 Ibid.
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changes to part 8 that expand access to
care, and promote engagement in OTP
services, while also maintaining
oversight and accreditation activities.
Oversight and accreditation standards
are supported as a means of promoting
evidence-based care, while minimizing
diversion and adverse patient and
public health outcomes.
C. Regulatory Background
On January 17, 2001 (66 FR 4075), the
Department issued final regulations for
the use of opioid agonist medications
(referred to as narcotic drugs at that
time) in treatment and withdrawal
management (referred to as
detoxification at that time) of OUD. The
final rule repealed the treatment
regulations enforced by the Food and
Drug Administration (FDA), and created
a new regulatory system based on an
accreditation model. In addition, the
final rule shifted administrative
responsibility and oversight from the
FDA to SAMHSA. This rulemaking
initiative followed a 1995 study,
‘Federal Regulation of Methadone
Treatment’ 29 by the Institute of
Medicine (IOM, now known as the
National Academy of Medicine) and
reflected recommendations by the IOM
and several other entities to improve the
treatment of OUD by allowing for
increased medical judgment in the care
of patients with OUD. The IOM report
recommended that the FDA processoriented 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.
To address these recommendations,
SAMHSA proposed a ‘‘certification’’
system based on accreditation. Under
the system, an applicant organization
who intended to dispense opioid
agonist medications in the treatment of
OUD must first obtain from SAMHSA,
a certification that the applicant is
qualified under the Secretary’s
standards and will comply with such
standards. Eligibility for certification
depended upon the applicant
organization obtaining accreditation
29 For
full text, see: https://
www.ncbi.nlm.nih.gov/books/NBK232108/
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from a private nonprofit entity, or from
a State agency, that had been approved
by SAMHSA to accredit OTPs.
Accreditation Bodies were directed to
base accreditation decisions on a review
of an application for accreditation and
on surveys (onsite inspections)
conducted every three years by OUD
treatment experts. In addition,
Accreditation Bodies must apply
specific opioid treatment accreditation
elements that reflect ‘‘state-of-the-art’’
opioid treatment guidelines. Further to
this, accreditation standards required
that OTPs have quality assurance
systems that consider patient outcomes.
The 2001 final regulations replaced
FDA ‘approval’ of programs, with direct
government inspection in accordance
with more detailed process-oriented
regulations. These process-oriented
regulations continue to prescribe many
aspects of oversight and treatment. To
this end, subpart B of the regulation
addressed accreditation and includes
steps that Accreditation Bodies must
follow to achieve approval to accredit
OTPs. It also set forth the Accreditation
Bodies’ responsibilities, including the
use of accreditation elements during
accreditation surveys. Subpart C
described the sequence and
requirements for obtaining certification
and addressed how and when programs
must apply for initial certification and
renewal of their certification. Subpart D
elucidated the procedures for review of
the withdrawal of approval of the
Accreditation Body or the suspension
and proposed revocation of an OTP
certification.
Since publication of the final rule in
2001, it has been updated on occasion
to include new medications, such as
buprenorphine, while also updating or
adding new rules governing the
provision of such medications. Subpart
F, added in 2016, described criteria for
increasing the patient limit for those
practitioners meeting Federal
requirements to prescribe
buprenorphine to 275.30
On December 29, 2022, the
‘Consolidated Appropriations Act, 2023’
(Pub. L. No: 117–328), was signed into
law and immediately eliminated the
requirement for individual practitioners
to obtain a waiver to prescribe certain
schedule III—V medications for the
treatment of OUD, commonly known as
the ‘‘DATA-Waiver.’’ Before the
Consolidated Appropriations Act, 2023
was enacted, ‘‘qualifying practitioners’’
were required to obtain waivers
(formerly under 21 U.S.C. 823(h)(2))
30 See https://www.federalregister.gov/
documents/2016/07/08/2016-16120/medicationassisted-treatment-for-opioid-use-disorders.
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from the separate DEA registration
requirement, under 21 U.S.C. 823(h),
that is needed to enable dispensing of
certain controlled medications used in
maintenance or withdrawal
management (‘‘detoxification’’)
treatment of OUD. Section 1252(b) of
the ‘Consolidated Appropriations Act,
2023’ (Pub. L. No: 117–328) also
required removal of the one-year history
of opioid misuse prior to admission to
an OTP. This was included in the part
8 NPRM (87 FR 77330), and public
comments supported the change.
In 2001 there were close to 900 OTPs,
but that number has grown to over 2,000
by 2023.31 Over this period, the
incidence of fentanyl misuse has
increased, escalating with the onset of
the COVID–19 pandemic in early 2020.
To protect the public’s health and
reduce the risk of COVID–19 infection
among patients and providers,
SAMHSA issued flexibilities in the
provision of take-home doses of
methadone and initiation of
buprenorphine via telehealth, including
through audio-only platforms, that
allowed for continued treatment of OUD
with reduced direct patient contact.
Each of these flexibilities represented a
significant change to previous treatment
standards and are discussed in detail
below. It is important to note that
SAMHSA has issued extensions to both
the initiation of buprenorphine via
telehealth flexibility and methadone
take-home flexibility, effective upon
expiration of the COVID–19 Public
Health Emergency, and in effect for the
period of one year from the end of the
COVID–19 Public Health Emergency, or
until such time that the U.S. Department
of Health and Human Services
publishes final rules revising 42 C.F.R
part 8, whichever occurs sooner.32
Flexibility For Methadone Medication
Take-Home Doses in Opioid Treatment
Programs
Among the existing standards for
medication administration and
dispensing of methadone are limitations
on unsupervised or ‘‘take-home’’ use.
These prior standards were established
early in the history of methadone as a
medication for OUD, and the criteria for
determining whether a patient may be
allowed take-home doses were
restrictive, requiring daily visits to the
OTP for extended periods of time, and
31 SAMHSA treatment locator. See https://
dpt2.samhsa.gov/treatment/directory.aspx.
32 See https://www.samhsa.gov/medicationssubstance-use-disorders/statutes-regulationsguidelines/methadone-guidance; and https://
www.samhsa.gov/medications-substance-usedisorders/statutes-regulations-guidelines/
buprenorphine-at-opioid-treatment-programs
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adherence to strict measures of
sustained stability as described in 42
CFR part 8.33 These criteria can pose
disruption to employment, education
and other daily activities for patients,
and several of the criteria reflect
outdated biases that promote stigma and
discourage people from engaging in care
in OTPs.
In March 2020, as a result of the
pandemic, SAMHSA issued exemptions
that permitted State regulatory
authorities to request blanket exceptions
to allow patients to take-home more
doses of methadone; 43 States and the
District of Columbia did so.34 With this
flexibility, SAMHSA allowed OTPs to
dispense up to 28 days of ‘‘take-home’’
methadone doses to ‘‘stable’’ patients for
the treatment of OUD, and up to 14
doses of ‘‘take-home’’ methadone for
‘‘less stable’’ patients ‘‘who the OTP
believes can safely handle this level of
take-home medication.’’ 35 Although the
duration of this flexibility was not
initially specified, a SAMHSA FAQ
published in April 2020, indicated that
the flexibility was tied with the duration
of ‘‘the current national health
emergency . . . .’’ 36
The intention of the methadone takehome flexibility was to reduce the risk
of COVID–19 infection among patients
and providers. Beyond this, the
flexibility promotes individualized care
that considers patient characteristics
and program involvement beyond time
in treatment. By reducing the burden on
patients to visit the OTP daily, this
flexibility may reduce stigma for those
seeking treatment, while also providing
more equitable access to care as
telemedicine in OTPs is expanded. It
also allows those who reside far from an
OTP or who lack access to reliable
transportation to receive treatment,
while also being able to gain or maintain
employment, attend school, care for
loved ones and engage in other required
activities of daily living.
The methadone take-home flexibility
has been met with widespread support
33 https://www.ecfr.gov/current/title-42/chapter-I/
subchapter-A/part-8?toc=1.
34 HHS Guidance for Opioid Treatment Programs.
https://www.samhsa.gov/sites/default/files/otpguidance-20200316.pdf.
35 See https://www.samhsa.gov/sites/default/files/
otp-guidance-20200316.pdf.
36 See https://www.samhsa.gov/sites/default/files/
faqs-for-oud-prescribing-and-dispensing.pdf.
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among patients,37 OTPs,38 and State
authorities.39 Patients reported that
increased take-home doses of
methadone left them feeling more
respected as responsible
individuals.37 40 In a national meeting,
State authorities reported that the
flexibilities were appreciated by
patients and OTPs alike, with no
significant change in rates of diversion
seen since the COVID–19 PHE was
declared.41 Indeed, analysis of the
relevant data indicates that the actual
level of misuse, diversion or harm from
methadone is more likely to occur when
it is prescribed for pain as opposed to
OUD, and that the rate of diversion is
lower than that of oxycodone or
hydrocodone.42 Additionally, a survey
found that diversion of methadone is
low among patients receiving take-home
doses under the COVID–19 PHE
flexibility.43 44 Further to this, analysis
of data on fatal overdoses from January
2019 to August 2021 demonstrated that
this flexibility did not lead to more
deaths involving methadone.45
37 Hatch-Maillette MA, Peavy KM, Tsui JI, BantaGreen CJ, Woolworth S, Grekin P. Re-thinking
patient stability for methadone in opioid treatment
programs during a global pandemic: Provider
perspectives. J Subst Abuse Treat. 2021
May;124:108223. doi: 10.1016/j.jsat.2020.108223.
Epub 2020 Dec 5. PMID: 33342667; PMCID:
PMC8005420.
38 Joseph G, Torres-Lockhart K, Stein MR, Mund
PA, Nahvi S. Reimagining patient-centered care in
opioid treatment programs: Lessons from the Bronx
during COVID–19. J Subst Abuse Treat. 2021
Mar;122:108219. doi: 10.1016/j.jsat.2020.108219.
Epub 2020 Dec 3. PMID: 33353790; PMCID:
PMC7833302.
39 ‘‘To Save Lives From Opioid Overdose Deaths,
Bring Methadone Into Mainstream Medicine’’,
Health Affairs Forefront, May 27, 2022.
40 Krawczyk, N., Rivera, B. D., Levin, E., &
Dooling, B. C. E. (2023). Synthesizing evidence of
the effects of COVID–19 regulatory changes on
methadone treatment for opioid use disorder:
implications for policy. The Lancet. Public health,
8(3), e238–e246. https://doi.org/10.1016/S24682667(23)00023-3
41 The 2022 American Association for the
Treatment of Opioid Dependence (AATOD)
Conference, Baltimore, Maryland, October 30—
November 3, 2022.
42 NIDA. 2018, June. Medications to Treat Opioid
Use Disorder. Retrieved from https://
irp.drugabuse.gov/wp-content/uploads/2019/12/
NIDA-Medications-to-treat-opioid-use-disorder_
2018.pdf.
43 Figgatt, MC, Salazar Z, Day E, Vincent L,
Dasgupta N. Take-home dosing experiences among
persons receiving methadone maintenance
treatment during COVID–19, Journal of Substance
Abuse Treatment, Volume 123, 2021, https://
doi.org/10.1016/j.jsat.2021.108276.
44 Dooling, B.C.E. & Stanley, L.E. (2021).
Unsupervised use of opioid treatment medications:
Report II of the extending pandemic flexibilities for
opioid use disorder treatment project. GW
Regulatory Studies Center. https://regulatory
studies.columbian.gwu.edu/unsupervised-useopioid-treatment-medications.
45 Jones, C. M., Compton, W. M., Han, B.,
Baldwin, G., & Volkow, N. D. (2022). Methadone-
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Recognizing the importance of this
flexibility, SAMHSA released guidance
on November 18, 2021, (subsequently
updated on April 19, 2023) 46 that
extended the methadone take-home
flexibility for one year past the end of
COVID–19 PHE (May 11, 2024), or until
such time that the Department publishes
this final rule, whichever occurs sooner.
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The Opioid Treatment Program
Flexibility To Prescribe MOUD via
Telehealth Without an Initial In-Person
Physical Evaluation
Telehealth is a mode of service
delivery that has been used in clinical
settings for over 60 years and
empirically studied for just over 20
years.47 48 49 Between 2016 and 2019, use
of telehealth, in general, doubled from
14 to 28 percent 50 while substance use
disorder (SUD) treatment, offered
through telehealth over the same period,
increased from 13.5 to 17.4 percent.51
This trend has rapidly increased
between 2019 and 2021, due to the
COVID–19 pandemic.52
The pandemic spurred use of
telehealth for the treatment of OUD with
buprenorphine, a schedule III partial
opioid receptor agonist. Prior to
buprenorphine’s development, the only
opioid agonist that could be used to
treat OUD was methadone dispensed
through OTPs. Methadone has a
relatively complicated pharmacological
profile, necessitating closer observation
Involved Overdose Deaths in the US Before and
After Federal Policy Changes Expanding TakeHome Methadone Doses From Opioid Treatment
Programs. JAMA psychiatry, e221776. Advance
online publication. https://doi.org/10.1001/
jamapsychiatry.2022.1776.
46 See https://www.samhsa.gov/medicationssubstance-use-disorders/statutes-regulationsguidelines/methadone-guidance
47 Bashshur, R. L., Shannon, G. W., Bashshur, N.,
& Yellowlees, P. M. (2016). The empirical evidence
for telemedicine interventions in mental disorders.
Telemedicine and e-Health, 22(2), 87–113.
48 Lustig, T. (2012). The role of telehealth in an
evolving health care environment: Workshop
summary. National Academies Press.
49 Mace, S., Boccanelli, A., & Dormond, M. (2018).
The use of telehealth within behavioral health
settings: Utilization, opportunities, and challenges.
University of Michigan School of Public Health,
Behavioral Health Workforce Research Center.
50 American Medical Association (2019).
Telehealth implementation playbook. Digital Health
Implementation Playbook Series. https://www.amaassn.org/system/files/2020-04/ama-telehealth
implementation-playbook.pdf
51 Uscher-Pines, L., Cantor, J., Huskamp, H. A.,
Mehrotra, A., Busch, A., & Barnett, M. (2020).
Adoption of telemedicine services by substance
abuse treatment facilities in the U.S. Journal of
Substance Abuse Treatment, 117, 108060.
52 Melamed OC, deRuiter WK, Buckley L, Selby
P. Coronavirus Disease 2019 and the Impact on
Substance Use Disorder Treatments. Psychiatr Clin
North Am. 2022 Mar;45(1):95–107. doi: 10.1016/
j.psc.2021.11.006. Epub 2021 Nov 12. PMID:
35219445; PMCID: PMC8585604.
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of new patients to ensure that initial
doses do not exceed an individual’s
tolerance for the medication.53
In response to the COVID–19 PHE, as
declared by Secretary Azar on January
31, 2020, pursuant to the authority
under section 319 of the Public Health
Service Act (42 U.S.C. 247), the DEA
granted temporary exceptions to the
Ryan Haight Act and DEA’s
implementing regulations under 21
U.S.C. 802(54)(D), one of the seven
distinct categories of telemedicine
envisioned under the statutory
definition of the practice of
telemedicine. In order to prevent lapses
in care, these exceptions allowed for the
prescribing of controlled medications
via telemedicine encounters even when
the prescribing practitioner had not
conducted an in-person medical
evaluation of the patient.
These telemedicine flexibilities
authorized practitioners to prescribe
schedule II–V controlled medications
via audio-video telemedicine
encounters, including schedule III–V
narcotic controlled medications
approved by the Food and Drug
Administration (FDA) for maintenance
and withdrawal management treatment
of opioid use disorder via audio-only
telemedicine encounters, provided that
such prescriptions otherwise comply
with the requirements outlined in DEA
guidance documents, DEA regulations,
and applicable Federal and State law.
DEA granted those temporary
exceptions to the Ryan Haight Act and
DEA’s implementing regulations via two
letters published in March 2020: the
March 25, 2020 ‘‘Dear Registrant’’ letter
signed by William T. McDermott, DEA’s
then-Assistant Administrator, Diversion
Control Division,54 and the March 31,
2020 ‘‘Dear Registrant’’ letter signed by
Thomas W. Prevoznik, DEA’s thenDeputy Assistant Administrator,
Diversion Control Division.55
Building upon this, SAMHSA
implemented OTP regulatory
flexibilities designed to help address the
impact of the COVID–19 pandemic on
53 Substance Abuse and Mental Health Services
Administration. Medications for Opioid Use
Disorder. Treatment Improvement Protocol (TIP)
Series 63 Publication No. PEP21–02–01–002.
Rockville, MD: Substance Abuse and Mental Health
Services Administration, 2021.
54 William T. McDermott, DEA Dear Registrant
letter, Drug Enforcement Administration (March 25,
2020), https://www.deadiversion.usdoj.gov/GDP/
(DEA-DC-018)(DEA067)%20DEA%20state%20
reciprocity%20(final)(Signed).pdf.
55 Thomas W. Prevoznik, DEA Dear Registrant
letter, Drug Enforcement Administration (March 31,
2020), https://www.deadiversion.usdoj.gov/GDP/
(DEA-DC-022)(DEA068)%20DEA%20SAMHSA%20
buprenorphine%20telemedicine%20
%20(Final)%20+Esign.pdf
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OTPs and their patients.56 In April
2020, SAMHSA exempted OTPs from
the requirement to perform an in-person
physical evaluation (under 42 CFR
8.12(f)(2)) for any patient who was to be
treated by the OTP with buprenorphine
if a program physician, primary care
physician, or an authorized healthcare
professional under the supervision of a
program physician, determined that an
adequate evaluation of the patient could
be accomplished via telehealth. The
duration of this exemption was
specifically tied with the ‘‘period of the
national emergency declared in
response to the COVID–19 pandemic’’,57
and the exemption did not include
induction of methadone via telehealth
technology.
Recent research has demonstrated that
telehealth can be an effective tool in
integrating care and extending the reach
of specialty providers,58 and that among
those patients requiring treatment with
buprenorphine, there are high levels of
satisfaction with the use of telehealth
services.59 Additionally, there are no
significant differences between
telehealth and in-person buprenorphine
induction in the rate of continued
substance use, retention in treatment or
engagement in services.58 60 Research
also shows that there is no significant
difference in client and provider ratings
of therapeutic alliance when using
telehealth technology platforms.59
Further to this, research demonstrates
that actions to facilitate access to
buprenorphine-based treatment for OUD
during the COVID–19 pandemic were
not associated with an increased
proportion of overdose deaths involving
buprenorphine.61
56 OTPs are authorized to dispense narcotic
maintenance and detoxification medication under
21 U.S.C. 823(h)(1) and regulated under 42 CFR part
8.
57 See https://www.samhsa.gov/sites/default/files/
faqs-for-oud-prescribing-and-dispensing.pdf.
58 Guille, C., Simpson, A. N., Douglas, E., Boyars,
L., Cristaldi, K., McElligott, J., Johnson, D., & Brady,
K. (2020). Treatment of opioid use disorder in
pregnant women via telemedicine: A
nonrandomized controlled trial. JAMA Network
Open, 3(1), e1920177-e1920177.
59 King, V. L., Brooner, R. K., Peirce, J. M.,
Kolodner, K., & Kidorf, M. S. (2014). A randomized
trial of web-based videoconferencing for substance
abuse counseling. Journal of Substance Abuse
Treatment, 46(1), 36–42.
60 Vakkalanka, J. P., Lund, B. C., Ward, M. M.,
Arndt, S., Field, R. W., Charlton, M., & Carnahan,
R. M. (2022). Telehealth Utilization Is Associated
with Lower Risk of Discontinuation of
Buprenorphine: a Retrospective Cohort Study of US
Veterans. Journal of general internal medicine,
37(7), 1610–1618. https://doi.org/10.1007/s11606021-06969-1.
61 Tanz, L. J., Jones, C. M., Davis, N. L., Compton,
W. M., Baldwin, G. T., Han, B., & Volkow, N. D.
(2023). Trends and Characteristics of
Buprenorphine-Involved Overdose Deaths Prior to
and During the COVID–19 Pandemic. JAMA
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On May 9, 2023, SAMHSA issued
guidance 62 that extended the
buprenorphine telehealth flexibility for
OTPs for one year past the end of
COVID–19 PHE, or until such time that
the Department publishes this final rule,
whichever occurs sooner. In the face of
an escalating overdose crisis and an
increasing need to reach remote and
underserved communities, making the
buprenorphine telehealth flexibility
permanent is of paramount importance.
This final rule permits initiation of
buprenorphine at the OTP, by the OTP
practitioner, if an OTP physician,
primary care physician, or other
authorized healthcare professional
under the supervision of a program
physician, determines that an adequate
evaluation of the patient can be, or was,
accomplished via audio-only or audiovisual telehealth technology.
SAMHSA believes that evidence
underlying the initiation of
buprenorphine using telehealth also is
applicable to the treatment of OUD with
methadone, and warrants expanding
access to methadone therapy by
applying some of the buprenorphine inperson examination flexibilities to
treatment with methadone in OTPs.63
However, SAMHSA also acknowledges
that there are differences between these
two medications. Accordingly, this final
rule allows for the use of audio-visual
telehealth for any new patient who will
be treated by the OTP with methadone
if a program physician, or an authorized
healthcare professional under the
supervision of a program physician,
determines that an adequate evaluation
of the patient can be accomplished via
an audio-visual telehealth platform.
SAMHSA is not extending this change
to the use of audio-only telehealth
platforms in assessing new patients who
will be treated by the OTP with
methadone because methadone, in
comparison to buprenorphine, holds a
higher risk profile for sedation in
patients presenting with mild
somnolence which may be easier to
identify through an audio-visual
telehealth platform. The final rule is not
applicable to, and does not authorize,
the prescription of methadone pursuant
to a telehealth visit. Instead, this change
applies to the ordering of methadone by
network open, 6(1), e2251856. https://doi.org/
10.1001/jamanetworkopen.2022.51856
62 See: https://www.samhsa.gov/medicationssubstance-use-disorders/statutes-regulationsguidelines/buprenorphine-at-opioid-treatmentprograms
63 Chan B, Bougatsos C, Priest KC, McCarty D,
Grusing S, Chou R. Opioid treatment programs,
telemedicine and COVID–19: A scoping review.
Subst Abus. 2022;43(1):539–546. doi: 10.1080/
08897077.2021.1967836. Epub 2021 Sep 14. PMID:
34520702.
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appropriately licensed OTP
practitioners and dispensed to the
individual patient by the OTP under
existing OTP procedures.
Further to this, health care providers
who receive Federal financial assistance
are reminded of their obligations to
ensure that their audio-only and audiovisual telehealth platforms are
accessible to individuals with
disabilities and afford an opportunity
for meaningful access for limited
English proficient (LEP) individuals.
Federal civil rights laws prohibit
discrimination on the basis of disability
and may require health care providers to
make reasonable modifications to their
policies, practices, or procedures to
ensure that a person who is not able to
use audio-visual telehealth platforms
based on their disability has an equal
opportunity to benefit from treatment
with MOUD. Similarly, Federal civil
rights laws prohibit discrimination on
the basis of national origin (including
language ability) and require recipients
to take reasonable steps to provide
meaningful access to LEP individuals.
This may require the provision of a
qualified interpreter and/or translated
material, such that they have the
opportunity benefit from treatment with
MOUD.
Expanding Access to Services
On June 28, 2021, the DEA introduced
allowance for OTPs to add a ‘‘mobile
component’’ to their existing
registration and waived any obligation
for an OTP mobile medication unit
complying with these requirements to
separately register at the remote
locations where it dispenses.64 On
September 21, 2021, SAMHSA released
guidance on the establishment of mobile
and non-mobile medication units and
allowable services.65 While part 8
currently allows OTPs certified by
SAMHSA to establish medication units
(as defined under 42 CFR 8.2), the final
rule further defines mobile units and
clarifies potential services, interventions
and accreditation processes.
Additionally, the COVID–19
pandemic highlighted the importance of
providing harm reduction services to
OTP patients. On April 7, 2021, the CDC
and SAMHSA jointly announced that
Federal funding could be used to
purchase rapid fentanyl test strips (FTS)
64 See https://www.federalregister.gov/
documents/2021/06/28/2021-13519/registrationrequirements-for-narcotic-treatment-programs-withmobile-components.
65 See https://www.samhsa.gov/medicationassisted-treatment/statutes-regulationsguidelines#mobile.
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7533
for drug checking purposes.66 This was
proposed in part to help curb the
dramatic spike in drug overdose deaths
largely driven by the use (both
intentional and unintentional) of potent
synthetic opioids, primarily illicitly
manufactured fentanyl. FTS can be used
to determine if drugs have been mixed
or cut with fentanyl, providing people
who use drugs and their communities
with important information about
fentanyl in the illicit drug supply so
they can take steps to reduce their risk
of overdose.
On December 16, 2022, HHS issued a
notice of proposed rulemaking (NPRM)
entitled ‘Medications for the Treatment
of Opioid Use Disorder’ (87 FR 77330).
In that NPRM, the Department proposed
to modify certain provisions of part 8 to
update Opioid Treatment Program
(OTP) accreditation and certification
standards, treatment standards for the
provision of medications for opioid use
disorder as dispensed by OTPs, and
requirements for individual
practitioners eligible to dispense
(including by prescribing) certain types
of Medication for Opioid Use Disorder
(MOUD) with a waiver under 21 U.S.C.
823(h)(2). Proposed changes sought to
make flexibilities put forth during the
COVID–19 PHE permanent, and to also
update standards to reflect an OTP
accreditation and treatment
environment that has evolved since 42
CFR part 8 came into effect in 2001. To
this end, the Department proposed to
update part 8 by: removing outdated
language; fostering a more patientcentered perspective; and reducing
barriers to receiving care. These
elements have been identified in the
literature and in feedback as being
essential to promoting effective
treatment and retention in care provided
by OTPs.
To expand access to care, the
Department proposed to update OTP
admission criteria as described in 42
CFR part 8. This included removal of
the one-year requirement for opioid
addiction before admission to an OTP,
in favor of consideration of problematic
patterns of opioid use. Indeed,
evidence-based standards of care
demonstrate that it is more prudent to
admit those individuals who either:
meet diagnostic criteria for active
moderate to severe OUD; are in OUD
remission; or are at high risk for
recurrence or overdose. In conjunction
with updated standards that include
extended take-home doses of methadone
and access to telehealth, this is likely to
66 See https://www.samhsa.gov/newsroom/pressannouncements/202104070200
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Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations
expand access while also improving
retention in treatment.
Additionally, the Department
proposed to update 42 CFR part 8 to
reflect evidence-based practice,
treatment standards, and the workforce
currently providing services in OTPs.
Proposed changes included: expanding
the definition of a treatment practitioner
to include any provider who is
appropriately licensed to dispense and/
or prescribe approved medications;
addition of evidence-based paradigms of
care such as split dosing, telehealth and
harm reduction activities; removing
outdated terms such as ‘detoxification’;
review of criteria for provision of takehome doses of methadone;
strengthening the patient-practitioner
relationship through promotion of
shared and evidence-based decision
making; allowing for early access to
take-home doses of methadone for all
patients to promote flexibility in
creation of plans of care that promote
recovery activities such as employment
or education, while also allowing those
with unstable access to reliable
transportation the opportunity to also
receive treatment; promotion of mobile
medication units to expand an OTP’s
geographic reach; and review
accreditation standards. The proposed
changes sought to organize existing
flexibilities and practice updates in a
manner that makes them permanent and
cohesive.
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Removal of DATA-Waiver Requirements
Section 1262(a)(1) of the Consolidated
Appropriations Act, 2023 (Pub. L. No:
117–328), which was enacted on
December 29, 2022, amended the CSA
(21 U.S.C. 823(h)) by eliminating the
requirement that practitioners obtain a
waiver to prescribe certain schedule
III—V medications for the treatment of
opioid use disorder (OUD). This
immediately removed the requirement
for practitioners to submit a notification
of intent and to receive the Drug
Addiction Treatment Act of 2000
(DATA)-Waiver before prescribing
buprenorphine.
Before the Consolidated
Appropriations Act, 2023 was enacted,
‘‘qualifying practitioners’’ were required
to obtain waivers (formerly under 21
U.S.C. 823(h)(2)) from a separate
registration requirement, under 21
U.S.C. 823(h), that is needed to enable
dispensing of certain schedule II—V
narcotic medications used in
maintenance or detoxification
treatment. Practitioners with a waiver of
this kind were limited in the number of
patients they could treat with this type
of medication at any one time.
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In July 2016, SAMHSA published a
final rule (81 FR 44711) that added
‘subpart F’ to 42 CFR part 8 under the
authority of former 21 U.S.C.
823(h)(2)(B)(iii)(III). Among other
things, subpart F authorized eligible
practitioners with a waiver under 21
U.S.C. 823(h)(2) to request approval to
treat up to 275 patients under certain
conditions. The December 16, 2022,
NPRM entitled ‘Medications for the
Treatment of Opioid Use Disorder’ (87
FR 77330), proposed three changes to
subpart F: (1) altering section headings
to remove the current question-andanswer style and replacing it with a
standard format; (2) updating Section
8.610 to remove stigmatizing language
and to also clarify that the 275-patient
waiver is limited to three years in
duration and; (3) removing Section
8.635 to eliminate annual reporting
requirements for practitioners approved
to treat up to 275 patients.
Pursuant to section 1262 of the
Consolidated Appropriations Act, 2023,
the Department published a
supplemental notice of proposed
rulemaking (SNPRM), entitled
‘Medications for the Treatment of
Opioid Use Disorder: Removal of the
DATA–2000 Waiver Requirements’ (88
FR 9221), on February 13, 2023. This
SNPRM proposed to remove in its
entirety subpart F of 42 CFR part 8 in
addition to language throughout 42 CFR
part 8 that specifically references or
implicates the DATA–2000 waiver
process.
D. Analysis and Discussion of
Comments
On December 16, 2022, the
Department published a notice of
proposed rulemaking entitled
‘Medications for the Treatment of
Opioid Use Disorder’ (87 FR 77330).
The public comment period ended on
February 14, 2023, and a total of 373
comments were received. On February
13, 2023, the Department also released
a supplemental NPRM entitled
‘Medications for the Treatment of
Opioid Use Disorder: Removal of the
DATA–2000 Waiver Requirements’ (88
FR 9221), to bring proposed changes to
42 CFR part 8 rule into alignment with
the ‘Consolidated Appropriations Act,
2023’ (Pub. L. 116–260). The
supplemental NPRM closed for public
comments on March 14, 2023. An
additional 27 comments were received,
the majority of which pertained to the
December 16, 2022, NPRM.
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General Comments
Terminology Changes, and Reducing
Stigma
Comments conveyed widespread
approval of terminology and language
changes aimed at expanding care while
also reducing stigmatization for patients
receiving treatment for OUD. Some
commenters noted that language
changes alone will not be sufficient to
eliminate, stigma, injustice, and
institutionalized marginalization.
Others were concerned that updated
language was not accurate—for
example, that it detracts focus from
other forms of treatment. One
commenter additionally suggested that
SAMHSA and other authorities consider
updating their organizations’ names to
maintain consistency with
destigmatizing language changes. Such
changes have been proposed by
SAMHSA and HHS,67 but not yet
enacted by Congress as of this date.
Another commenter suggested
eliminating or reducing the
requirements for random toxicology
testing as an important method to
further reduce stigma and loss of bodily
autonomy among a population that has
often faced violent and punitive
treatment. They also suggest
reexamining the differential regulation
of methadone versus buprenorphine.
Response: SAMHSA recognizes the
role of language in perpetuating stigma
and discrimination, and is committed to
taking steps to use language that is
positive, patient-centered, productive
and inclusive. It recognizes that
changing language, alone, will not
immediately eliminate harms suffered
by those struggling with and in recovery
from substance use disorders. SAMHSA
and its Federal, State, local, Tribal and
territorial partners have been working to
impact health equities and promote
justice through its programs, services
and regulations, as evidenced in the
improvements made in this regulatory
language. SAMHSA has also
emphasized support for recovery and
recovery services.68 It will take time to
assure consistency of language
throughout documents; changing names
of Federal agencies requires legislative
action. Toxicology testing is a clinical
tool that is used to inform the treatment
process, should never be used
punitively, and must be conducted in a
way that is respectful of the individual
and in accordance with clinical and
67 See https://www.samhsa.gov/sites/default/files/
samhsa-fy-2024-cj.pdf.
68 See https://www.samhsa.gov/find-help/
recovery?
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Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations
professional standards.69 Also, the
different regulation of methadone (in
schedule II) versus buprenorphine (in
schedule III) stems from how these
substances are scheduled and from how
they are regulated under 21 U.S.C.
823(h), which requires ‘‘practitioners
who dispense narcotic drugs (other than
narcotic drugs in schedule III, IV, or V)
to individuals for maintenance
treatment or detoxification treatment’’ to
obtain an annual separate registration
for that purpose.
Error in Citations
One commenter expressed concern
that several cited research studies were
not accurately interpreted as used for
this NPRM. For example, citation 103 is
used as justification for provision of
counseling at OTPs, but the study was
done in a primary care setting. Another
commenter stated that the same
reference, 103, is incorrect and the
citation in the body does not match the
DOI link—one references HIV testing in
Africa while it appears they intend to
reference the HSU study on psychiatric
comorbidity.
Response: SAMHSA made every effort
to ensure that the citations listed were
correct. The error noted with citation
103 has been rectified. Within the body
of the text, the citation is appropriate as
the text explicitly describes this study
and highlights that in combination with
other evidence, a comprehensive
approach to treatment is associated with
improved outcomes. Indeed, the
proposed rule also includes evidence
from other settings such as Emergency
Departments. It is important to note that
economic analysis of OUD treatment
interventions is uncommon and so
assessment of such evidence requires
consideration of all sources.
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Comments on Accreditation Standards
One-Year Accreditation Following One
Recommendation
Many commenters opposed the
proposed change under Section 8.4, that
provides, based on their understanding,
only one-year accreditations to OTPs
with recommendations. They believe
this change in accreditation regulations
will essentially end three-year
accreditations. Commenters stated that
with the number of standard ratable
elements it is unreasonable to expect
facilities to meet every accreditation
element. With about 1,400 elements
evaluated during each survey, not
having even one recommendation is an
unobtainable standard for many OTPs.
Commenters stressed that having such a
69 See https://store.samhsa.gov/sites/default/files/
d7/priv/pep15-fedguideotp.pdf.
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high standard would result in a
substantial number, if not all, of OTPs
having to submit to an annual
accreditation inspection.
Response: Section 8.4 addresses the
responsibilities of the Accreditation
Bodies. Since 2001, Section 8.4(b), in
response to noncompliant programs
stated ‘‘(1) If an Accreditation Body
receives or discovers information that
suggests that an OTP is not meeting
Federal opioid use disorder treatment
standards, or if survey of the OTP by the
Accreditation Body otherwise
demonstrates one or more deficiencies
in the OTP, the Accreditation Body
shall as appropriate either require and
monitor corrective action or shall
suspend or revoke accreditation of the
OTP, as appropriate based on the
significance of the deficiencies.’’ The
proposed rule retained language about
noncompliance with one or more
standards as it refined expectations for
Accrediting Bodies’ follow up with
these programs. Based on comments,
this final rule clarifies the intent of this
subpart and survey and accreditation
requirements, while also explicitly
clarifying that non-critical findings
would not result in only a one-year
accreditation.
Implementation Schedule Not To
Exceed 60 Days
One comment drew attention to the
33% reduction in time this proposed
change allows for submitting an
implementation schedule, pursuant to
Section 8.4. The commenter believes
this would introduce significant new
barriers to the delivery of care to
persons with OUD while doing nothing
to improve the standard of care. Other
commenters agreed that 60 days is an
insufficient amount of time to
adequately address recommendations in
a manner that improves patient care.
Response: SAMHSA thanks
commenters for this information. Based
on the comments, the time frames
allotted for noncompliant OTPs to
implement corrections in section 8.4
were extended to 180 days. This
recognizes that some corrective
measures may take more than 60 days
to successfully implement.
Surveyor Subjectivity and Need for
Flexibility
In reference to Section 8.4, several
commenters mentioned that
accreditation surveys are affected by the
subjective interpretations of individual
auditors, and that this subjectivity
contributes to their objection to one
recommendation being a preclusion for
a three-year accreditation. Some OTP
guidelines may no longer be consistent
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with newly proposed rules and are
inconsistent with current evidencebased practices. Further, several
commenters urged flexibility in
accreditation decisions as the unique
situations of many OTPs prevents
constant, exact compliance. In other
words, commenters urged flexibility in
decision making based on center needs
and circumstances as well as the
seriousness of the recommendation(s)
and its effect on patient care and safety.
Response: SAMHSA reviews the
policies and procedures of all
Accreditation Bodies, including those
related to the training and supervision
of surveyors. SAMHSA meets regularly
with the Accrediting Bodies to assure
consistency in the application and
interpretation of 42 CFR part 8. It also
reviews the performance of
Accreditation Bodies by inspecting a
selected sample of the OTPs accredited
by the respective Body each year, and,
under section 8.4 will receive reports of
OTP surveys when deficiencies are
discovered. Together, these help to
ensure consistency across and within
Accreditation Bodies. Following
finalization of this rule, SAMHSA
intends to update the 2015 Federal
Guidelines for OTPs 70 to assure the
OTP guidelines are consistent with
newly proposed rules and with current
evidence-based practices.
Cost Burden
Commenters reported concern that
proposed changes to accreditation, in
Section 8.4, will result in more frequent
inspections, which will require
significant time and financial
expenditures. Commenters expressed
their conviction that the increased
frequency of inspections will take
providers away from patient care and
direct the focus of both providers and
administrators away from patient needs.
Furthermore, inspections have financial
costs for OTPs; some commenters
asserted that the cost to some OTPs of
more frequent surveys might be more
than the OTP can financially bear. Many
commenters fear that the additional
administrative and financial costs will
lead to fewer OTPs and thus reduced
options for patients in dire need of
treatment.
Response: SAMHSA has made
changes to Section 8.4 of this final rule
to respond to commenter concerns
about potentially increased rates of oneyear accreditation results. In the final
rule, Section 8.4(b) has been altered to
not only clarify the criteria for one-year
or three-year accreditation, but to also
70 See https://store.samhsa.gov/sites/default/files/
d7/priv/pep15-fedguideotp.pdf.
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remove potential misunderstanding
around whether a specific number of
recommendations might lead to less
than three-year accreditations. Rather
than implement a specific number of
recommendations that might lead to less
than three-year accreditation, the final
rule determines the length of
accreditation based on the severity of
the non-compliance. With this
clarification in the final rule, rates of
one year accreditation and repeat
surveys are not expected to increase.
proposed rule specifically amended the
duration of interim treatment from 120
days to 180 days so that on a temporary
basis, a patient may receive services
from an OTP, while awaiting access to
more comprehensive treatment services.
Language pertaining to public and notfor-profit OTPs has been removed from
the final rule in order to expand access
to interim treatment among all OTPs.
This is done in recognition of a need to
bring individuals into treatment and in
response to public comment.
Comments on Treatment Standards
Expanding the Definition of Long-Term
Care Facilities
MOUD Treatment Criteria Changes
Commenters overwhelmingly
conveyed support for discontinuing
requirements for a one-year history of
OUD to access treatment as well as
support for those changes that update
admission criteria for minors. Some
commenters also suggested that
SAMHSA should remove the
requirement that individuals cannot
initiate methadone treatment more than
twice a year.
Response: The final rule removes the
requirement, previously at 8.12(e)(2),
that minors are required to have had
two documented unsuccessful attempts
at short-term ‘‘detoxification’’, or
withdrawal management, or drug-free
treatment within a 12-month period to
be eligible for maintenance treatment,
and that those seeking withdrawal
management, previously under
8.12(e)(4), cannot initiate methadone
treatment more than twice per year.
Instead, OTPs shall ensure that patients
are admitted to treatment by qualified
personnel who have determined, using
accepted medical criteria, that: the
person meets diagnostic criteria for a
moderate to severe OUD; the individual
has an active moderate to severe OUD,
or OUD in remission, or is at high risk
for recurrence or overdose. There is
nothing stated within the Federal
regulations or statutes that limits the
number of times a person can initiate
treatment with methadone or any other
medication.
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Interim Treatment
Comments supported extending
interim treatment from 120 days to at
least 180. Commenters request the
availability of interim maintenance
treatment through all OTPs and not just
public and private not-for-profit OTPs,
pursuant to 8.12(j)(1). Some
commentors suggested interim
treatment provision in primary care
providers’ offices.
Response: Interim treatment was
developed to expand access to OTP
services in urgent circumstances. The
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There is widespread support among
commenters for the addition of jails and
prisons under the definition of longterm care facilities at 8.11(h)(3), thus
expanding the waiver of OTP
certification to better allow for equitable
access to treatment and reduce the
potential for civil rights violations.
Group homes and withdrawal
management programs are also
mentioned by some commenters in this
context, as well as any licensed nonhospital residential treatment programs
with medical staffing, a DEA registration
and the ability to administer/store/
dispense prescription medications.
Several commenters also requested the
removal of waiver language that
specifies the OUD diagnosis be
secondary to another condition.
Response: Language has been added
to the final rule, at Section 8.11(h)(3), to
highlight that these flexibilities may
apply to a correctional facility that has
registered with the DEA as a hospital/
clinic. If a correctional facility has
registered as a hospital/clinic, a
physician or authorized staff may
administer or dispense narcotic drugs to
maintain or manage withdrawal for an
inmate as an incidental adjunct to
medical or surgical treatment of
conditions other than addiction. Rules
regarding controlled substance
dispensing that is outside the context of
OTPs, such as waiver language that
specifies the OUD diagnosis be
secondary to another condition, is
beyond the scope of this rulemaking.
SAMHSA notes that the Centers for
Medicare & Medicaid Services released
new guidance encouraging States to
apply for a new Medicaid re-entry
Section 1115 waiver demonstration
project for those persons leaving jails
and prisons that this final rule may help
facilitate.71
71 See
https://www.cms.gov/newsroom/pressreleases/hhs-releases-new-guidance-encouragestates-apply-new-medicaid-reentry-section-1115demonstration.
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Expanding Methods of Access via OTPs
and Their Mobile Units
Commenters support easing
pathways, under section 8.11, for
opening new OTPs by enacting changes
to ease or eliminate barriers, such as
extending certification periods,
providing funding opportunities, or
encouraging existing syringe service
programs to grow into new OTPs.
Commenters also support expanding
geographical access at current OTPs by
easing regulations on their mobile units.
They remarked on transportation
challenges for people with OUD and
that having access to mobile units will
assist those who otherwise might not be
able to attend a clinic in a fixed
location.
Response: Recognizing the many
pathways to expanding access, the final
rule makes permanent flexibilities
implemented during the COVID–19 PHE
and updates the overall regulations to
reflect ways in which the accreditation
and treatment environment has evolved
since part 8 went into effect in 2001.
Proposed changes that facilitate delivery
of comprehensive services in mobile
units, such as the use of telehealth, have
been made permanent as they reduce
barriers to receiving care, among other
goals. Regulations regarding mobile
units were eased by the DEA and
SAMHSA, and use of funds allocated to
States under the Block Grant were
approved for use in the purchase of
mobile units.72 Some commenters
reference State-specific regulations that
limit mobile units, but Federal OTP
regulations do not preempt separate
State requirements. SAMHSA fully
encourages and facilitates additional
OTP applications.73
Expanding Methods of Access via Office
and Community Settings
Many commenters emphasized that
methadone treatment must be allowed
outside of OTPs, such as in office-based
settings or dispensing in community
pharmacies, as many communities do
not have access to OTPs. Commenters
asserted that this approach has been
successfully implemented in other
countries and SAMHSA must work with
the DEA to move in this direction.
Furthermore, this may help to address
stigma associated with and criticism of
some OTPs and will help promote the
cultural view of OUD as a chronic
disease that necessitates respectful
patient-centered care.
72 See https://www.samhsa.gov/sites/default/files/
2021-letter-state-authorities-mobile.pdf.
73 See https://www.samhsa.gov/medicationssubstance-use-disorders/become-accredited-opioidtreatment-program.
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Response: The final 42 CFR part 8
rule only applies to dispensing of
methadone in OTPs. SAMHSA
continues to work with Federal partners
to explore ways through which access to
MOUD might be expanded.
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Expanding the Definition of a
Practitioner
There was strong support from
commenters regarding expanding the
definition of providers, under Section
8.2, who are able to prescribe or order
medications. Commenters expressed
that allowing licensed practitioners,
such as physician assistants, nurse
practitioners, and certified nurse
midwives, will result in improved
access to patients, especially in areas
with a high level of provider shortages.
There was further support to add
pharmacists to the definition of
qualified providers. Commenters felt
that including pharmacists as qualified
providers will further improve
accessibility for people suffering with
OUD.
Response: Pursuant to the
supplemental notice of proposed
rulemaking entitled ‘Medications for the
Treatment of Opioid Use Disorder:
Removal of the DATA–2000 Waiver
Requirements’ (88 FR 9221)
requirements for staff credentials are
finalized to include the definition of a
practitioner as ‘‘a health care
professional who is appropriately
licensed by a State to prescribe and/or
dispense medications for opioid use
disorders and, as a result, is authorized
to practice within an OTP’’. The scope
of 42 CFR part 8 is also limited to
activities within an OTP.
One commenter requested
clarification on the context of certified
nurse-midwives (CNMs) practice with
MOUD. Another commenter requested
clarification on scope of practice for
physician assistants and nurse
practitioners prescribing methadone, as
there appear to be more restrictions
compared to buprenorphine.
Response: As noted above, the
definition of a practitioner was
modified. However, not all States allow
CNMs, nurse practitioners, physician
assistants, or pharmacists to order
methadone unless supervised by a
physician. Notwithstanding additional
flexibilities provided in this final rule,
practitioners must continue to adhere to
State requirements that may apply to the
provision of methadone and scope of
practice. As also noted, this final rule
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does not apply to the prescribing of
methadone for OUD outside of OTPs.
Food and Drug Administration (FDA)
Approval of Testing Supplies
Some commenters requested the
removal of the proposed change
requiring drug testing services be FDA
approved, under Section 8.12(f)(6), as
this would impede their ability to test
for fentanyl with an instant testing
method. Another commenter requested
more clarity, stating that this rule could
preclude what they view as medically
necessary definitive testing at qualified
laboratories, despite the lack of an FDA
review pathway for such testing. As the
drug supply continues to rapidly evolve,
OTP medical directors need the
flexibility to use the best available tests,
regardless of FDA approval, to provide
effective patient care.
Response: SAMHSA has amended
Section 8.12(f)(6) to specifically allow
for distribution of testing strips for drug
checking, to those patients who wish to
test their supply for adulteration, where
not prohibited by law. The final rule
also clarifies that FDA approved tests be
used when conducting random drug
testing with patients, including urine or
saliva samples, at the OTP.
Support for Provision of Resources With
Patient-Centered Care Plans
Commenters were supportive of
Section 8.12(5)(i) that requires OTPs to
work with patients to provide additional
services such as counseling and harm
reduction (including education, testing,
and treatment for HIV, viral hepatitis,
and sexually transmitted infections
(STIs) when helpful), but some
commenters cautioned requiring
provision of these services without
establishing their funding and requested
in the meantime that the language be
amended to include assessment and
referral. Additionally, comments
overwhelmingly conveyed support for
clarifying that attending counseling is
not a condition of MOUD treatment, and
that treatment plans should be patient
centered.
Response: Part 8 defines what is
expected in the provision of methadone
for the treatment of OUD. Although it is
expected that OTPs plan for their fiscal
viability to assure continuity of
medication and other treatment
services, funding and sustainability are
beyond the scope of these regulations.
OTPs are expected to offer adequate
medical, counseling, vocational,
educational, and other assessment, and
treatment services either onsite or by
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referral to an outside agency or
practitioner. The revisions in this final
rule promote a patient-centered
approach to care that does not make
medication continuity contingent upon
involvement in counseling services but
fosters greater shared decision-making.
The revisions also relaxed the
requirement that an OTP have a formal
documented agreement with outside
agencies; under Section 8.12(f)(1) the
final rule calls for a ‘‘documented
agreement’’ to provide such services.74
Further Consideration of Tribal
Communities
Some commenters advocate for
increased Tribal sovereignty by
including Indian Tribes as potential
Accreditation Bodies. Additionally,
while the Indian Health Service is
included in the list of exceptions for
State law compliance, OTPs operated by
Indian Tribes must also be included to
align with Tribal sovereignty.
Accordingly, when States or ‘‘State law’’
is referenced, they urge SAMHSA to
also include Tribes or ‘‘Tribal law’’.
Another commenter communicates
concern about lack of safe transportation
and funding to access treatment on
some Tribal reservations,
institutionalized racism and
marginalization, as well as lack of
positive integration of American Indian/
Alaska Native culture into treatment for
those populations. The commenter
indicates that it is vital that SAMHSA
alter the rule to explicitly include
addressing the needs of marginalized
communities, including Tribes and
Tribal entities.
Response: SAMHSA recognizes the
need for culturally supportive care that
addresses race, ethnicity, Tribal
sovereignty, sexual orientation, religion
and gender identity, and social
determinants of health, such as housing
and transportation, that may pose
barriers to treatment engagement, or
harm reduction and recovery support
service needs. Patient-centered language
in the NPRM was finalized in this rule
to ensure that the care provided is
consistent with the patient’s needs, and
self-identified goals for treatment and
recovery. SAMHSA encourages OTPs
serving American Indians and Alaska
Natives to implement culturally
competent and patient-centered care.
SAMHSA notes that it and other
agencies have developed resources that
74 See https://www.samhsa.gov/sites/default/files/
dear-colleague-letter-fda-samhsa.pdf.
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may be helpful in developing culturally
sensitive approaches for AI/AN
populations.75
The Department has not included
‘Tribal law’ whenever ‘State law’ is
referenced, as Tribal laws vary widely.
Accordingly, understanding what the
reference means, or its scope, in some
situations may be ambiguous. Therefore,
it would be inappropriate to include
Tribal law in this context.
Intake
Commenters requested clarification
on the application of the new intake
rules under Section 8.12(f)(2). Some
commenters requested that clarification
include explicit descriptions of rule
application to clinical scenarios such as
care transitions from hospital or nonOTP settings to OTPs. Commenters were
supportive of allowing non-OTP
clinicians to complete the intake
screening and full examinations to
expedite access during this process,
though some commentors specified that
the OTP provider must later review and
approve the exams completed outside of
an OTP. Some commentors stated that
more frequent regular medical exams
may be helpful during the first year of
treatment to ensure safety and efficacy
of treatment. One commenter requested
clarification as to whether the full
physical exam includes a mental status
exam or an assessment of psychiatric
symptoms, due to the high incidence of
such symptoms among these patients.
Another commenter requested clarity as
to whether methadone may be initiated
during the 14-day grace period for full
OTP intake and screening/full
examination, as some State regulations
interpret this differently.
Response: The final regulations,
under Section 8.12(f)(2)(a), facilitate
initial screening to allow for medication
to commence at time of initial intake;
SAMHSA recommends methadone
medication induction not be delayed
until the full examination is
completed.76 The purpose of the initial
screening is to ensure that there are no
contraindications to prescribing
methadone; this may require a
psychiatric screening or evaluation of
psychiatric symptoms, if clinically
indicated. If mental health is not
assessed at the time of screening, it
should be completed subsequently as
part of the patient’s assessment to
75 See https://www.samhsa.gov/behavioralhealth-equity/ai-an.
76 Substance Abuse and Mental Health Services
Administration. Medications for Opioid Use
Disorder. Treatment Improvement Protocol (TIP)
Series 63 Publication No. PEP21–02–01–002.
Rockville, MD: Substance Abuse and Mental Health
Services Administration, 2021.
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identify any service needs. Proposed
regulations were finalized as written,
since they explicitly address these
comments.
Commenters were concerned about
the requirement to complete a
psychosocial assessment within 14
days, stating that patients often
experience instability at the time of
entry into treatment, which makes this
difficult; some commenters suggest
providing 30 days to complete the
assessment. One commenter also
requested an exception be provided to
ensure patients diagnosed with OUD are
not excluded from MOUD because of
documented failure or that only
documentation of reasonable effort to
complete this assessment is required.
Another commenter adds that this short,
prescriptive timeframe is not always
conducive to developing therapeutic
rapport between patients and providers
and may force programs to be overly
restrictive, disrupting patient
engagement at a critical time.
Response: Patients entering treatment
for OUD are often in crisis and this is
the basis for the requirement that a
complete psychosocial assessment be
conducted within 14 days. This is
especially important because the final
rule allows patients new to treatment to
receive up to 7 take-home doses of
methadone. The psychosocial
assessment informs part of the initial
examination, and as such, it is the basis
of continued assessment and
management as indicated. There is no
requirement for a definitive list of
diagnoses to be created at this time.
Rather, this is an opportunity to create
a detailed plan of care which might
include continued assessment and
monitoring of psychosocial status. To
facilitate timely completion of the
assessment, the final rule includes
flexibilities for the use of telehealth.
Serology Testing
For serology testing, comments
recommend the patient should
explicitly retain the right to refuse or
defer testing unless the medical
provider deems it necessary for patient
safety. Others asked for clarification on
the deadline (14-day or 30-day) stating
that 8.12 (f)(2)(B)(iii) and (iv) as
proposed appeared contradictory.
Response: An individual patient
always has the right to refuse testing,
and this provision therefore has been
clarified in the final rule. Specifically at
8.12(f)(2)(i)(b), now states that a
‘‘patient’s refusal to undergo lab testing
should not preclude them from access to
treatment, provided such refusal does
not have the potential to negatively
impact treatment with medications’’. In
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regard to the suggested 14-day or 30-day
discrepancy, these timeframes refer to
use of serology results: it is permissible
to use serology results drawn no more
than 30 days prior to admission to the
OTP, or up to 14 days after admission
to the OTP to complete the full
examination. Thus, these two provisions
are not inconsistent.
Treatment Discharge Concerns
Several comments expressed concern
over removal of language in the
proposed rule concerning discharge,
asserting that this change removes
important patient protections that have
helped to promote humane discharge
processes. Whether patients are
discharged for nonpayment or other
reasons, commenters emphasize that
tapering schedules must be based on
clinical and safety considerations.
Response: The importance of
discharge planning has been highlighted
in the final rule. Specifically, under
Section 8.11(f)(2)(iv) discharge
decisions have been enumerated to
require a patient-centered approach.
Such decisions must be documented,
and planned in a manner that ensures,
to the greatest extent possible, that
patient treatment is not disrupted.
Proposed language from the NPRM
pertaining to discharge planning
throughout Section 8.12 has been
finalized.
Split Dosing
Numerous commenters support the
expansion of split dosing for all OTP
patients receiving take-home doses,
defined in Section 8.2, based on the
clinical judgement of the OTP
practitioner, and urge SAMHSA to add
language specifying that additional
testing and submission of
documentation for split dosing is
unnecessary if the clinician has clearly
documented in the medical record that
split dosing will benefit the patient.
Commenters also emphasize that takehome doses are essential for split
dosing, especially for pregnant patients
and patients driving long distances to
receive medication.
Response: The final rule does not
specify requirements of any additional
testing or documentation beyond that of
routine clinical practice. There is
nothing in the final rule that precludes
provision of split doses for take-home
doses of methadone.
Dosage During Treatment Induction
At Section 8.12(h)(3)(ii) commenters
emphasize that higher initial and next
day doses are often clinically
appropriate and necessary to prevent
withdrawal and treatment attrition,
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especially for patients exposed to
fentanyl, as well as for patients in the
later stages of pregnancy, and that
clinicians require more clarification on
this. Commenters questioned whether
the additional medication is
administered as one higher dose or
additional, incremental dose(s) at
several hour interval(s). They worry that
lack of clarity will result in
underutilization and thus lower
treatment retention. Some commenters
suggest eliminating induction dosing
guidelines (which they view as a
reflection of longstanding stigma and
discrimination against patients in OTP
treatment). These commenters suggest
entrusting these decisions to
practitioners, noting that other
medication dosage decisions for many
medical conditions are left to judgment
and discretion of medical providers.
Some commenters also caution that
higher induction doses must not be
discouraged when medically necessary
for efficacious treatment.
Response: A primary purpose of the
final rule is to promote use of clinical
judgement as well as patient-centered
care. These comments speak to the need
for ‘‘shared decision-making’’ in the
practitioner-patient relationship, and
the final rule supports this through
empowering practitioners to work with
patients to create individualized plans
of care. Section 8.12(h)(3)(ii) has been
clarified in a manner that does not
prohibit higher induction doses, but
requires the rationale for higher
induction doses to be documented in
the patient’s record.
Audio-Only Telehealth
Commenters emphasize that audioonly telehealth is an important
permanent provision for counseling and
buprenorphine initiation to ensure more
equitable access to OTPs.
Response: SAMHSA agrees with
commenters that telehealth, including
audio-only telehealth, can be an
important tool to enhance access to
treatment. SAMHSA also recognizes
scientific evidence that further supports
integration of telehealth provisions in
the final rule consistent with clinical
guidelines and safety requirements. The
final rule accordingly states that in
evaluating patients for treatment with
schedule III medications (such as
Buprenorphine) or medications not
classified as a controlled medication
(such as Naltrexone), audio-visual or
audio only platforms may be used at the
patient and provider’s preference. For
schedule II medications (such as
Methadone), the rule allows for audiovisual telehealth initiation by the OTP
practitioner. When audio-visual
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technologies are not available or their
use is not feasible for a patient, it is
acceptable to use audio-only devices,
but only when the patient is in the
presence of a licensed practitioner who
is registered to prescribe (including
dispense) controlled medications. This
is because, as noted, in the proposed
rule, schedule II medications such as
methadone pose increased risk
compared to schedule III medications
such as buprenorphine. In all cases,
medications for the treatment of OUD
shall be ordered by the OTP
practitioner.
Audio/Visual Telehealth for Medical
Intake and ‘‘Annual Physical’’
Appointments
Video-based telehealth, under section
8.12(f)(2)(B)(v), is overwhelmingly
supported by commenters for medical
intake, periodic medical assessments,
and methadone or buprenorphine
initiation by OTP practitioners. Onsite
staff can supplement telehealth care by
gathering vital sign and toxicology data,
when necessary. One comment
questioned if any appropriate limits, for
example on the number of patients a
single physician could oversee via
telehealth should be added.
Response: SAMHSA appreciates these
comments and has finalized proposed
changes in the final rule. Requirements
pertaining to telehealth, including the
number of patients that a practitioner
may see, are governed by applicable
State and Federal laws. As noted above,
however, provisions in this final rule
support use of telehealth as part of
patient treatment.
Take-Home or Unsupervised Doses
Provisions expanding take-home or
unsupervised methadone medication
doses, under Section 8.12(i), are mostly
supported, with commenters citing
increased patient autonomy and pride,
improved outcomes and treatment
retention, and reduced barriers to
treatment. The removal of the eight takehome criteria is accordingly supported
by some, though others note that
toxicology testing is important to help
maintain public and patient safety.
Some commenters expressed concern
about potentially increased diversion,
while another commented that
diversion is a sign of unmet community
need and should be addressed as such,
rather than criminalized. Some
commenters worried that the revised
take-home allowances are too flexible
and some proposed different guidelines;
others supported them or even wanted
them eliminated entirely, trusting
providers with that responsibility. Yet,
other commenters worried that leaving
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decisions about take-homes completely
to the discretion of providers could
result in provider abuse and suggested
that some parameters are necessary.
Many commenters expressed
frustration that not all patients receive
equitable access to take-homes, whether
for insurance reasons or lack of clinic/
state implementation. Some
commenters suggest the addition of
take-home metrics during the OTP
survey process to help address this.
Another commenter suggested
SAMHSA provide a method of recourse
for patients dissatisfied with decisions
made about their take-home eligibility.
One commenter requested clarification
on insurance coverage of take-home
doses, specifically with Medicare or
Medicare Part D. One commenter asked
that SAMHSA end the requirement for
requested program exceptions when
closing or dispensing extra take-home
doses for weather emergencies and state
holidays, and that patient suitability
documentation for days the clinic is
closed is only required for patients
denied take-home medication.
Response: SAMHSA recognizes that
its proposed provisions concerning takehomes were significant. Proposed
changes have been finalized without
alteration. While this approach
promotes practitioner discretion,
determining risk factors and preventing
diversion has required team input since
the original regulations were
promulgated over 20 years ago.
A standard for treatment that is
common to all Accreditation Bodies is
that OTPs have policies regarding
patient complaints and procedures that
protect patients from retaliation.
SAMHSA requires that Accreditation
Bodies have policies and procedures in
place to respond to complaints received
from the Secretary, patients, facility
staff, and others. Therefore, patients
who have complaints about take-homes
shall have access to recourse through
required patient complaint and
grievance procedures.
Determinations about insurance
coverage and reimbursement for MOUD,
while important, are outside the scope
of this rulemaking.
Need for More Data
Several commenters expressed an
ongoing need for more data to ensure
treatment changes (such as additional
take-home medication doses, induction
dosing schedules, expansion of the
definition of a qualified provider) are
safe, especially post COVID–19 public
health emergency (PHE) as
circumstances and environments
change. Some had concerns that
changes provided too much flexibility,
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especially with respect to take-home
doses during the first week(s) of
treatment, due to less patient stability/
functionality during this transitional
period. Others mentioned that patients
might handle medications differently
outside of the COVID–19 PHE
environment, due to lack of behaviormodifying factors present during the
PHE, such as isolation and fear for
continued treatment. Other commenters
expressed the need for more data related
to induction dosing and best practices
for rapid induction to effective doses
while minimizing risk.
Response: Data is important to
performance monitoring and
evaluations of health care interventions.
Accreditation standards require that
OTPs have quality assurance systems
that consider patient outcomes. The
data related recommendations noted in
these comments are items that could be
incorporated into the OTPs quality
assurance processes. These
recommendations are better addressed
in the revision of the Federal OTP
guidelines that SAMHSA will complete
following this rulemaking. SAMHSA
and its partners, including the Centers
for Disease Control and Prevention, FDA
and National Institutes of Health (NIH),
support further research on these issues,
and SAMHSA will monitor the impact
of this rule. As one example, FDA,
SAMHSA and the Reagan-Udall
Foundation held a meeting in May 2023
regarding ‘Considerations for
Buprenorphine Initiation and
Maintenance Care’ to ‘‘explore realworld experiences and scientific
evidence for buprenorphine initiation
strategies as well as medication dosing
and management during continued
treatment across different care
settings.’’ 77 SAMHSA and NIH
similarly collaborate to support the
Helping to End Addiction Long-term®
Initiative which focuses on improving
pain treatment and developing
community-level solutions to opioid
addiction.78 SAMHSA will continue on
its own and with other agencies and
stakeholders to explore and support
research on these issues.
patients of child-bearing potential from
seeking treatment.
Response: Pregnancy testing is often
necessary for appropriate clinical care,
and the final rule clarifies that
pregnancy testing should be requested
only when clinically appropriate, and
that refusal of such testing should not
preclude access to treatment.
Safeguarding patient privacy and health
is essential, and in all cases, providers
must adhere to State and Federal laws
and regulations, clinical requirements
and professional guidelines when
considering screening and disclosure of
testing results. For instance, the 2015
‘American College of Obstetricians and
Gynecologists policy on Alcohol Abuse
and Other Substance Use Disorders:
Ethical Issues in Obstetric and
Gynecologic Practice’, emphasizes the
importance of patient informed consent
for testing.79
Ramifications of Dependency Diagnosis
One commenter expressed concern
that under Section 8.12(f)(2), all patients
receiving opioids must be documented
in the medical chart with an opioid
dependence diagnosis, even if the
patient is a pain patient and the doctor
has no dependency concerns. One
commenter is concerned that this could
affect eligibility for future organ
transplants.
Response: These regulations establish
the procedures by which the Secretary
of HHS determines whether a program
is qualified to dispense methadone and
other medications in the treatment of
opioid use disorders and standards
regarding the use of these medications
for treatment purposes, in accordance
with the Controlled Substances Act
(CSA) under 21 U.S.C. 823(h). As a
result, a diagnosis of opioid use disorder
is required. SAMHSA notes that opioid
dependence is an older diagnostic term
that, in the U.S., has been replaced with
the diagnostic term of opioid use
disorder and associated diagnostic
criteria. Proposed changes, as written,
were finalized in the rule.
Pregnancy Testing
Several commenters advised against
requiring pregnancy testing, under
Section 8.12(f)(B)(iii), for pregnant OTP
patients. They reasoned that, in a time
when States are increasingly restricting
and even criminalizing reproductive
options, pregnancy testing may dissuade
Protecting Patient Data
Central registries are often queried to
detect and prevent potential multiple
enrollments in more than one OTP.
Central registries are briefly described in
42 CFR part 2 (Confidentiality of
Substance Use Disorder Patient Records)
regulations, but one commenter is
concerned that there do not appear to be
limits on their collection and sharing of
sensitive patient information and
77 See https://reaganudall.org/news-and-events/
events/considerations-buprenorphine-initiationand-maintenance-care.
78 See https://heal.nih.gov/.
79 See https://www.acog.org/clinical/clinicalguidance/committee-opinion/articles/2015/06/
alcohol-abuse-and-other-substance-use-disordersethical-issues-in-obstetric-and-gynecologic-practice.
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requests regulations better clarify
appropriate practices.
Response: Central registries are Statebased operations. Although the patient
information is protected, procedures for
assuring protection and relevant
regulations such as 42 CFR part 2 and
the Health Insurance Portability and
Accountability Act are outside the scope
of these Part 8 regulations.
Alignment of State and Federal
Guidelines
There were many commenters that
expressed concerns with State
regulations as they intersect with
proposed SAMHSA changes. If States
have more restrictive regulations,
especially related to medication
administration, for instance, then
patients in those States may not benefit
from Federal changes, some commenters
asserted. These commenters urged that
States be required to align with Federal
regulations, even if it means
withholding funds to States who refuse
to adopt new Federal regulations. Some
commentors also requested language be
added mandating State Opioid
Treatment Authorities (SOTAs) are
included in communications such as
when and how an OTP is not meeting
standards, withdrawal of approval of
Accreditation Bodies, and others.
Response: These rules do not mandate
that States promulgate less restrictive
rules to match provisions of Federal law
that may provide more flexibility.
SAMHSA works closely and
collaboratively with the SOTAs and
State mental health and substance use
disorder treatment authorities, the
Accreditation Bodies, as well as other
Federal agencies to encourage State and
Federal alignment and informationsharing.
Other Themes
There were two comments that urged
keeping Levomethadyl acetate (LAAM)
on the list of approved treatment
medications. These comments suggested
that research could indicate it is an
effective treatment for opioid use
disorder and that it may soon be
available for use again. Additionally,
other comments advocated integration
of other FDA-cleared treatment options
like neuromodulation and other medical
technology.
Response: Currently, LAAM is not
available in the United States. For this
reason, it was removed from the list of
currently approved and available
medications for OUD. The list provided
in the rule is current, and there is
nothing that precludes changes to the
list of medications used to treat OUD in
the future. Technology is not currently
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addressed in 42 CFR part 8 as devices
and available applications are an
adjunct to treatment with MOUD.
SAMHSA will monitor the development
and approval of new medical devices by
FDA for the treatment of chronic opioid
use disorder and will consider updates
to part 8 as needed.
E. Summary of the Final Rule
The Department has finalized the
following changes to 42 CFR part 8 that
revise, delete, replace, or add sections.
This section summarizes changes in the
final rule, and discusses changes made
after review of public comments on the
NPRM entitled ‘Medications for the
Treatment of Opioid Use Disorder’ (87
FR 77330), and the SNPRM entitled
‘Medications for the Treatment of
Opioid Use Disorder: Removal of the
DATA–2000 Waiver Requirements’ (88
FR 9221).
1. Title
The Department has finalized the
title, originally proposed in the NPRM,
as being: Medications for the Treatment
of Opioid Use Disorder. As discussed in
the NPRM, this title reflects current
medical terminology and removes
stigmatizing language. The term ‘opioid
use disorder’ more precisely reflects the
diagnosis for which medications are
indicated. Further to this, the terms
‘maintenance’ and ‘detoxification’
reference outdated terminology that has
potentially hindered adoption of
evidence-based treatments for OUD.80
The amended title reflects current
medical terminology and highlights that
OUD is a chronic, treatable condition.
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2. Subpart A
Reorganization of subpart A, as
proposed in the NPRM and SNPRM, has
been finalized and includes the scope
and definitions.
3. Section 8.1—Scope
Pursuant to the NPRM and SNPRM,
§ 8.1 is finalized to reflect modern
medical terminology, to detail updated
acronyms, and for clarity. Of note, the
term medication assisted treatment
(MAT) has been updated to medications
for opioid use disorder (MOUD), and the
term treatment program has been
changed to opioid treatment program
throughout the final rule. Pursuant to
proposed changes set forth in the
SNPRM entitled ‘Medications for the
Treatment of Opioid Use Disorder:
80 NIDA. 2021, November 29. Words Matter—
Terms to Use and Avoid When Talking About
Addiction. Retrieved from https://nida.nih.gov/
nidamed-medical-health-professionals/healthprofessions-education/words-matter-terms-to-useavoid-when-talking-about-addiction.
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Removal of the DATA–2000 Waiver
Requirements’ (88 FR 9221), reference to
subpart F has been removed.
4. Section 8.2—Definitions
Changes proposed by the NPRM and
SNPRM have been finalized in § 8.2 to
add, remove and update definitions.
Added definitions include: care plan;
harm reduction; individualized dose;
long-term care facility; recovery support
services; split dosing; and telehealth.
Existing definitions updated include:
comprehensive treatment; medication
for opioid use disorder; and
practitioner. The term detoxification
treatment is removed and replaced with
withdrawal management. Definitions for
additional credentialing, approval term,
covered medications, and emergency
situation have been removed.
5. Section 8.3—Application for
Approval as an Accreditation Body
Changes proposed by the NPRM are
finalized to include details of policies
and procedures expected of
Accreditation Bodies, particularly that
Accreditation Bodies shall include staff
physician(s) with experience in treating
OUD with MOUD in their survey team.
Furthermore, this regulation is updated,
pursuant to the NPRM, to ensure that
Accreditation Bodies provide training
policies specifically related to training
of survey team members. As described
in the NPRM, the final rule also
provides for Indian Tribes, in addition
to State or territorial governments, to
apply for approval as an Accreditation
Body.
6. Section 8.4—Accreditation Body
Responsibilities
In response to public comments,
language that clarifies SAMHSA’s
oversight of Accreditation Bodies, and
associated expectations, has been
updated and finalized. To this end, the
Department has provided clarification
on the steps to be taken by
Accreditation Bodies in response to
OTPs that are found to not be complying
with accreditation or certification
standards, such as follow up on
corrective measures and confirmation of
timely corrections. In particular, section
8.4(b) of the final rule includes:
provisions requiring categorization of
the types of non-compliance; provisions
that differentiate between accreditation
duration based on the severity of noncompliance; and adds provisions
detailing procedures for severe noncompliance. Time frames for submission
of survey reports are also finalized.
Pursuant to the NPRM, the Department
has finalized the requirement that all
records of accreditation activities be
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made available to SAMHSA upon
request. Current requirements regarding
Accreditation Body follow up on
complaints are maintained but, as per
the NPRM, the final rule adds a
requirement that Accreditation Bodies
notify SAMHSA of all aspects of a
complaint response within 5 days of
receipt. Similarly, the previous rule
requiring surveyors to recuse
themselves from surveys due to conflict
of interest is amended to clarify that
such conflicts must be documented by
the Accreditation Body and made
available to SAMHSA.
7. Section 8.11—Opioid Treatment
Program Certification
This section is finalized, pursuant to
the NPRM, to update categories of
certification, to clarify the requirement
that OTPs maintain certification, and to
establish procedures for OTPs whose
certification has lapsed. Terms for the
extension of certification are finalized,
as are the means of requesting an
extension. The final rule also updates
the certification application process to
reflect the shift from paper applications
to electronic submission, and the email
address for submission of supporting
documents is corrected.
As described in the NPRM, the final
rule removes ‘‘Transitional
certification’’ which expired as a
category of certification in 2003.
Further, the wording of ‘‘Provisional
certification’’ is amended to clarify that
it is a category of certification available
only to new programs that have not
been previously certified, and a new
category of ‘‘Conditional Certification’’
has been added for OTPs that have
received a one-year conditional
accreditation status from an Accrediting
Body—an organization that has been
approved by the Secretary of HHS to
accredit OTPs—in order for operations
to continue or resume as the OTP takes
steps needed to achieve permanent
certification. The criteria for granting
certification extensions outside of
routine certification renewals has been
expanded to address extensions needed
under extraordinary circumstances. The
grammar used in describing procedures
for requesting an extension was revised.
The applicability of Health Insurance
Portability and Accountability Act
(HIPAA) privacy protections have been
explained, along with clarification that
changes in the status of the program
sponsor or medical director must be
submitted to SAMHSA in writing.
Pursuant to the NPRM, the conditions
for approval of interim treatment have
been finalized to increase the duration
of interim treatment from 120 days to
180 days, with the stipulation that
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individuals shall not be discharged
without the approval of an OTP
practitioner while awaiting transfer to a
comprehensive treatment program. In
response to public comments on the
NPRM, availability of interim treatment
is also expanded to all OTPs. For clarity,
reference to section 1923 of the Public
Health Service Act (21 U.S.C. 300x–23)
is removed. The NPRM and final rule
also shifts the need to seek approval
from the ‘chief public health officer’ of
the State in which the OTP operates to
the State Opioid Treatment Authority in
the State in which the OTP operates.
As described in the NPRM, the
services that can be provided in
medication units have been finalized to
explicitly allow the full range of OTP
services, based on space and privacy
available in the medication unit.
8. Section 8.12—Federal Opioid Use
Disorder Treatment Standards
Revisions of treatment standards, as
described in the NPRM, are finalized in
order to improve access to treatment,
improve patient satisfaction and
engagement in services and support use
of clinical judgment in decision-making.
In several instances, stigmatizing
language such as ‘‘legitimate treatment
use’’ of controlled medications, has
been removed and patient-centered
language is added.
The paragraph on staff credentials,
found in the NPRM, is finalized to
expand the definition of a practitioner
to a ‘‘a health care professional who is
appropriately licensed by a State to
prescribe and/or dispense medications
for opioid use disorders and, as a result,
is authorized to practice within an
OTP.’’ The expectation that all licensed
and credentialed staff maintain
licensure and/or certification has been
finalized.
Criteria for admission to treatment, as
discussed in the NPRM, removes
reference to the Diagnostic and
Statistical Manual of Mental Disorders
(DSM) IV and eliminates the
requirement for a one-year history of
OUD. Instead, the final rule specifies
that the individual should either: meet
diagnostic criteria for active moderate to
severe OUD; that the individual may be
in OUD remission; or at high risk for
recurrence or overdose. The section is
finalized to ensure that the basis for the
admission decision is documented in
the patient’s record. In recognition of
the use of telehealth and its limitation
in obtaining physical signatures, the
requirement to obtain written patient
consent to treatment is altered to the
extent that consent may be provided
verbally or electronically, and
documented as such. The requirement
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that individuals under age 18 have two
documented unsuccessful attempts at
short term withdrawal management
(‘‘detoxification’’) or drug free treatment
is also finalized so to allow consent of
a parent, legal guardian, or responsible
adult. Further to this, the rule requiring
a 1-year history of OUD for people
recently released from correctional
settings, pregnant patients or previously
enrolled individuals has been removed.
Throughout the document, as
described in the NPRM,
‘‘detoxification’’ and the corresponding
definition and standards for short-and
long-term detoxification treatment have
been removed. ‘‘Withdrawal
management’’ and terms for tapering
from MOUD are added on behalf of
individuals who seek this approach or
who elect or need to reduce and/or
discontinue MOUD.
The paragraph on ‘‘Required services’’
is finalized to incorporate patientcentered language, establish flexible
terminology, promote use of clinical
judgment, and clarify SAMHSA’s
expectations of OTPs. The final rule
creates the requirement that services be
available that meet patient needs, and
‘‘shared decision making’’ is added as
the method to be used in developing
care plans.
The paragraph describing the initial
medical examination has been finalized,
pursuant to the NPRM, to clarify the
terms ‘‘screening’’ medical exam and
‘‘comprehensive examination’’, while
also expanding the qualifications of
practitioners able to complete such
examinations. These include
practitioners outside of the OTP (with
limitations and specific instructions).
The final rule also creates criteria for lab
testing conducted prior to a screening
medical exam, as well as a permissible
timeframe. The use of telehealth in
undertaking the screening medical exam
and initiation of MOUD at the OTP, by
the OTP practitioner, has also been
finalized in the rule. Additionally, the
paragraph on special services for
pregnant people is finalized to specify
that confirmation of pregnancy should
be requested for priority treatment
admissions. The option to use split
dosing for patients, as described in the
NPRM, is also finalized.
The components of initial and
periodic medical examinations have
been finalized, pursuant to the NPRM,
to incorporate assessment of behavioral
health, risk of self-harm or harm to
others, and to specify time frames for
completion of the care plan. Areas of
psychosocial assessment are finalized so
as to assure information is gathered in
the context of the patient’s whole life
such as their mental health, housing,
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recovery support and harm reduction
resources. Additionally, patientcentered language has been finalized,
such as ‘‘services a patient needs and
wishes to pursue’’.
The final rule expands the provision
of ‘counseling services’ that are
provided by OTPs to include
psychoeducational services, harm
reduction and recovery-oriented
services, and counseling and linkage to
treatment for anyone with positive test
results on human immunodeficiency
virus (HIV), viral hepatitis, and other
sexually transmitted infection (STI)
panels, or from OTP-provided medical
examinations. Language about services
that must be provided directly or
through referral is finalized to promote
a patient-centered approach to care that
does not make medication continuity
contingent upon involvement in
counseling services but fosters shared
decision-making for all care plans.
The requirement that an OTP have a
formal documented agreement with
outside agencies is finalized to remove
the word ‘‘formal’’; the final rule calls
for a ‘‘documented agreement’’ to
provide such services.
Language that addresses drug testing
services has been finalized to remove
stigmatizing phrases, such as ‘‘drug
abuse’’, and to remove content on shortterm withdrawal management
(‘‘detoxification’’). Further to this, the
final rule clarifies that the requirement
to use drug tests that have received the
Food and Drug Administration (FDA)’s
marketing authorization is limited to
random drug testing using samples
obtained from patients, including urine
or saliva. Pursuant to public comments
on the NPRM, the final rule does not
preclude distribution of legally
permissible testing supplies, that check
for adulteration of an individual’s
personal drug supply.
Rules that address recordkeeping and
efforts to avoid simultaneous enrollment
in multiple OTPs are finalized, as per
the NPRM, to be more declarative, such
as changing the word ‘‘review’’ to
‘‘determine’’ whether or not a patient is
enrolled in another OTP, and
documenting review efforts in the
patient’s record to demonstrate the good
faith efforts made. The final rule also
expands the circumstances in which a
patient may obtain treatment at another
OTP to include instances when there is
an inability to access care at the OTP of
record.
As described in the NPRM,
specification of disciplines authorized
to administer or dispense MOUD is
removed from the final rule. LAAM,
also known as Levomethadyl acetate, is
removed from the list of treatment
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medications because it is no longer
available, and other medications
approved since prior revisions to this
rule were added. In response to public
comments, the regulation of an initial
dose of methadone has been increased
to 50mg on the first day, with the
clarification of allowance for higher
doses if clinically indicated, and
documented in the patient’s record. The
rule to ensure documentation of any
significant deviation from FDAapproved labeling has been maintained
in the final rule, while redundant
language was removed.
Rules on the provision of
unsupervised (or take-home) doses of
methadone are finalized, as per the
NPRM, to incorporate flexibilities
issued in response to the COVID–19
pandemic. In general, the final criteria
allow up to 7 days of take-home doses
during the first 14 days of treatment, up
to 14 take-home doses from 15 days of
treatment and up to 28 take-home doses
from 31 days in treatment. The
requirement that OTPs maintain
procedures to protect take-homes from
theft and diversion is finalized, as well
as patient education on safe transport
and storage of take-home doses,
including documentation of the
provision of this education in the
patient’s clinical record.
Consistent with the conditions for
approval of interim treatment, the final
rule extends the potential duration of
interim treatment from 120 days to 180
days. It also clarifies the circumstances
in which interim treatment may apply
and maintains priority access to
comprehensive services for pregnant
individuals. The rule finalizes removal
of the requirement for observation of all
daily doses during interim treatment. It
also finalizes the expectation that crisis
services and information pertaining to
locally available, community-based
resources for ancillary services be made
available to individual patients in
interim treatment. A requirement of a
plan for continuing treatment beyond
180 days of interim services is also
finalized.
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9. Section 8.13—Revocation of
Accreditation and Accreditation Body
Approval
References to an OTP as a ‘‘program’’
instead of a ‘‘facility’’ are finalized.
10. Section 8.14—Suspension or
Revocation of Certification
Pursuant to the NPRM, this section
finalizes the actions that SAMHSA may
take when immediate intervention is
necessary to protect the public’s health
or safety. The final rule specifies the
administrative actions available to
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SAMHSA in the event that a program
sponsor, or any employee of an OTP
has: been found to have engaged in
misrepresentation in obtaining
certification; failed to comply with the
Federal Opioid Use Disorder treatment
standards; failed to comply with
reasonable requests from SAMHSA or
from an Accreditation Body for records;
or refused a reasonable request of a duly
designated SAMHSA inspector, DEA
Inspector, State Inspector, or
Accreditation Body representative for
permission to inspect the program or the
program’s operations or its records.
11. Subpart D—Procedures for Review
of Suspension or Proposed Revocation
of OTP Certification, and of Adverse
Action Regarding Withdrawal of
Approval of an Accreditation Body
References to an OTP as a ‘‘program’’
instead of a ‘‘facility’’ are finalized.
12. Subpart F—Authorization To
Increase Patient Limit to 275 Patients
This subpart and corresponding
sections are removed from the final rule,
as described in the SNPRM.
Severability
The Department asserts that
provisions in this final rule are
severable. If any provision of this rule,
or the application thereof to any person
or circumstance is held invalid, that
invalidity shall not affect other
provisions or applications of this rule
that can be given effect without the
invalid provision or application.
This rule has been organized in a way
that separates out the major provisions
into distinct sections and subparts.
Many of the provisions in this rule are
independent of each other and could
function sensibly even without certain
other provisions being in effect. For
example, the provisions in subparts A,
B and C related to accreditation and
certification are distinct from the
Treatment Standards enumerated in
subpart C section 8.12. Rules related to
take-home dosing of methadone are also
severable from other rules, such as those
regarding telehealth and interim
treatment.
If any specific provision of this rule
is found unconstitutional or invalid, the
Department intends that the remainder
would still operate independently. The
Department believes that each provision
in this rule offers a distinct benefit to
the public, patients, and healthcare
providers. Therefore, if any specific
application or provision is invalidated,
the remainder of the legally valid
provisions should remain in effect.
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7543
Regulatory Impact Analysis
The Department has examined the
impact of the final rule as required by
Executive Order 12866 on Regulatory
Planning and Review, 58 FR 51735
(October 4, 1993); Executive Order
13563 on Improving Regulation and
Regulatory Review, 76 FR 3821 (January
21, 2011); Executive Order 13132 on
Federalism, 64 FR 43255 (August 10,
1999); Executive Order 13175 on
Consultation and Coordination with
Indian Tribal Governments, 65 FR
67249 (November 9, 2000); Executive
Order 13985 Advancing Racial Equity
and Support for Underserved
Communities Through the Federal
Government, 86 FR 7009 (January 25,
2021); the Congressional Review Act,
Public Law 104–121, sec. 251, 110 Stat.
847 (March 29, 1996); the Unfunded
Mandates Reform Act of 1995, Public
Law 104–4, 109 Stat.48 (March 22,
1995); the Regulatory Flexibility Act,
Public Law 96–354, 94 Stat. 1164
(September 19, 1980); Executive Order
13272 on Proper Consideration of Small
Entities in Agency Rulemaking, 67 FR
53461 (August 16, 2002); the
Assessment of Federal Regulations and
Policies on Families, Public Law 105–
277, sec. 654, 112 Stat. 2681 (October
21, 1998); and the Paperwork Reduction
Act of 1995, Public Law 104–13, 109
Stat. 163 (May 22, 1995).
Statement of Need
This final rule is being issued to
update part 8 in response to increasing
opioid overdose deaths, exacerbated by
the COVID–19 pandemic.81 Across the
United States in 2021, 9.2 million
people aged 12 or older misused heroin
or misused prescription pain relievers
in the preceding twelve months.82 The
percentage was highest among young
adults aged 26 or older (3.5 percent or
7.7 million people), followed by adults
aged 18 to 25 (3.1 percent or 1 million
people). It was lowest among
adolescents aged 12 to 17 (1.9 percent
81 Cartus AR, Li Y, Macmadu A, Goedel WC,
Allen B, Cerda´ M, Marshall BDL. Forecasted and
Observed Drug Overdose Deaths in the US During
the COVID–19 Pandemic in 2020. JAMA Netw
Open. 2022 Mar 1;5(3):e223418. doi: 10.1001/
jamanetworkopen.2022.3418. PMID: 35311967;
PMCID: PMC8938716.
82 Substance Abuse and Mental Health Services
Administration. (2022). Key substance use and
mental health indicators in the United States:
Results from the 2021 National Survey on Drug Use
and Health (HHS Publication No. PEP22–07–01–
005, NSDUH Series H–57). Center for Behavioral
Health Statistics and Quality, Substance Abuse and
Mental Health Services Administration. https://
www.samhsa.gov/data/report/2021-nsduh-annualnational-report.
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or 497,000 people).83 These numbers
likely underestimate the true prevalence
of opioid misuse and opioid use
disorder (OUD), since the use of illicitly
manufactured fentanyl has not to date
been considered in the National Survey
on Drug Use and Health (NSDUH), and
populations likely to have high
prevalence of opioid misuse and use
disorder, such as individuals in the
criminal justice system, other
institutionalized settings, and
individuals experiencing homelessness
and not living in shelters, are not
included in the NSDUH.
Further to this, there are important
equity considerations evidenced by the
data. A recent analysis by the Centers
for Disease Control and Prevention
(CDC) demonstrates high levels of
overdose among non-Hispanic Black,
American Indian and Alaska Native
communities over the course of the
pandemic.83 This study showed that
overdose death rates rose 44 percent in
2020 for Black people and 39 percent for
American Indian and Alaska Native
people, compared with 22 percent for
white people.83 Black youth ages 15 to
24 saw an 86 percent increase in
overdose deaths, the largest spike of any
age or race group, while Black men 65
and older were nearly seven times as
likely than white men to die from an
overdose.83 It was also found that Black
people were less than half as likely as
white people to have received substance
use treatment. As SAMHSA has noted,
the Hispanic community also has been
adversely impacted by opioid
overdoses.84
Research demonstrates that MOUD
can reduce mortality from overdose by
up to 59% (based on results of
multivariable Cox proportional hazards
models adjusted for age; sex; baseline
anxiety diagnosis; depression diagnosis;
receipt of methadone, buprenorphine,
opioid, and benzodiazepine
prescriptions in the 12 months before
index nonfatal opioid overdose; and
time-varying receipt of opioid
prescriptions, benzodiazepine
83 Kariisa M, Davis NL, Kumar S, et al. Vital
Signs: Drug Overdose Deaths, by Selected
Sociodemographic and Social Determinants of
Health Characteristics—25 States and the District of
Columbia, 2019–2020. MMWR Morb Mortal Wkly
Rep 2022;71:940–947. DOI: https://dx.doi.org/
10.15585/mmwr.mm7129e2. See also https://
www.seattletimes.com/nation-world/nation/
addiction-treatment-medicine-is-vastlyunderprescribed-especially-by-race-study-finds/.
84 Substance Abuse and Mental Health Services
Administration: The Opioid Crisis and the
Hispanic-Latino 1opulatiorgent Issue. Publication
No. PEP20–05–02–002. Office of Behavioral Health
Equity. Substance Abuse and Mental Health
Services Administration, 2020. https://
store.samhsa.gov/sites/default/files/pep20-05-02002.pdf.
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prescriptions, withdrawal management
episode, and short- and long-term
residential treatments),85 yet few people
who may benefit from these medications
have immediate and sustained access to
them.86
The pattern of enrollment in programs
providing methadone was established in
the latter part of the 20th century.87
Research reveals that the rate of
methadone treatment at that time was
highest in low-income urban areas.88
These patterns have remained relatively
unchanged since the expansion of
access to buprenorphine in 2002.
Research demonstrates that there are
extensive ’treatment deserts’ where
there is little to no physical access to
OTPs, especially in rural areas.89
SAMHSA believes that changes to part
8 will, as described above, facilitate:
• Enhanced access to medications for
opioid use disorder, such as through
take-home doses of methadone and
extending interim treatment to 180 days;
• Reduced stigma and discrimination
based on changes to ensure updated
language and terminology;
• Clarification of standards applying
to Accreditation Bodies; and
• Revising Federal Opioid Use
Disorder Treatment Standards.
SAMHSA notes below that these
changes are associated with limited
burden as the final rule does not
substantially alter reporting or
accreditation activities. The changes
will support SAMHSA in its role of
overseeing Accrediting Bodies and
OTPs, modernizing language and
expectations in response to current
challenges and anticipated future
trends.
85 Larochelle MR, Bernson D, Land T, Stopka TJ,
Wang N, Xuan Z, Bagley SM, Liebschutz JM, Walley
AY (2018). Medication for Opioid Use Disorder
After Nonfatal Opioid Overdose and Association
With Mortality: A Cohort Study. Ann Intern Med.
Aug 7;169(3):137–145. doi: 10.7326/M17–3107.
86 Winograd RP, Presnall N, Stringfellow E, Wood
C, Horn P, Duello A, Green L, Rudder T. (2019). The
case for a medication first approach to the treatment
of opioid use disorder. Am J Drug Alcohol Abuse.
2019;45(4):333–340. doi: 10.1080/
00952990.2019.1605372. Epub 2019 May 14. PMID:
31084515.
87 D’Aunno T, Pollack HA. (2002). Changes in
methadone treatment practices: results from a
national panel study, 1988–2000. JAMA.
2002;288(7):850–856. doi:10.1001/jama.288.7.850.
88 Strain EC, Stitzer ML, Liebson IA, Bigelow GE.
(1994). Comparison of buprenorphine and
methadone in the treatment of opioid dependence.
Am J Psychiatry. 1994 Jul;151(7):1025–30. doi:
10.1176/ajp.151.7.1025. PMID: 8010359.
89 Mitchell P, Samsel S, Curtin KM, Price A,
Turner D, Tramp R, Hudnall M, Parton J, Lewis D.
(2022). Geographic disparities in access to
Medication for Opioid Use Disorder across US
census tracts based on treatment utilization
behavior. Soc Sci Med. 2022 Jun;302:114992. doi:
10.1016/j.socscimed.2022.114992. Epub 2022 Apr
28. PMID: 35512612.
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A. Executive Orders 12866 and 13563
and Related Executive Orders on
Regulatory Review
Executive Order 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
if regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety effects; distributive impacts;
and equity). Executive Order 13563 is
supplemental to, and reaffirms the
principles, structures, and definitions
governing regulatory review as
established in, Executive Order 12866.
This final rule is partially regulatory
and partially deregulatory. The
Department estimates that because
much of what has been finalized does
not substantially alter current practice
as implemented over the past 3 years
under the COVID PHE, the final rule
will not result in significantly altered
costs. Further to this, the final rule
creates efficiencies in service delivery
and in administration. These include
strengthening the patient-practitioner
relationship in a manner that promotes
efficient, evidence-based and patientcentered care, updating accreditation
procedures and providing a stable
regulatory environment. Additionally,
the final rule makes permanent some
OTP treatment flexibilities implemented
within the past three years.
B. Executive Order 13985 Advancing
Racial Equity and Support for
Underserved Communities Through the
Federal Government
A recent analysis by the Centers for
Disease Control and Prevention (CDC)
demonstrates high levels of overdose
among Black, American Indian and
Alaska Native communities over the
course of the pandemic.90 While these
trends existed long before the COVID–
19 PHE, this study highlights that
overdose death rates rose 44 percent in
2020 for Black people and 39 percent for
American Indian and Alaska Native
people, compared with 22 percent for
white people.91 Black youth ages 15 to
24 saw an 86 percent increase in
overdose deaths, the largest spike of any
90 Kariisa M, Davis NL, Kumar S, et al. Vital
Signs: Drug Overdose Deaths, by Selected
Sociodemographic and Social Determinants of
Health Characteristics—25 States and the District of
Columbia, 2019–2020. MMWR Morb Mortal Wkly
Rep 2022;71:940–947. DOI: https://dx.doi.org/
10.15585/mmwr.mm7129e2.
91 Krawczyk, N., Rivera, B.D., Levin, E., &
Dooling, B.C.E. (2023). Synthesizing evidence of the
effects of COVID–19 regulatory changes on
methadone treatment for opioid use disorder:
implications for policy. The Lancet. Public health,
8(3), e238–e246. https://doi.org/10.1016/S24682667(23)00023-3.
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age or race group, while Black men 65
and older were nearly seven times as
likely than white men to die from an
overdose.90 It was also found that Black
people were less than half as likely as
white people to have received substance
use treatment.
This disparity amplifies the
importance of promoting patientcentered care that is culturally
appropriate and responsive to patient
need, while also fostering a treatment
environment that promotes and sustains
patient engagement. The final rule
facilitates the practitioner-patient
relationship in a manner that espouses
these principles, while also expanding
the reach of OTPs (through activities
such as mobile medication units) to
physically engage communities that are
in need of intervention. Further to this,
the final rule promotes examination of
a patient’s cultural needs as they engage
in treatment services. This is consistent
with evidence-based and culturally
responsive paradigms of care.
The final rule also facilitates patient
engagement through removing, at the
practitioner’s discretion, the
requirement to attend an OTP each day.
Indeed, the ability to provide
unsupervised doses of methadone early
in treatment allows those with unstable
access to transportation, for example, to
focus on recovery activities in their own
community. Evidence from the past
three years demonstrates safety, as well
as high patient and practitioner
satisfaction with take-home doses of
methadone.91 This is principally
because take-home doses of methadone
allow individuals the opportunity to
engage in employment, education and
other activities that are supportive of
recovery and longer-term community
involvement.
1. Cost-Benefit Analysis
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a. Overview
The U.S. estimated economic cost of
opioid use disorder ($471 billion) and
fatal opioid overdose ($550 billion),
prior to the pandemic, totaled $1,021
billion.92 Among the 39 jurisdictions
reviewed in this analysis, combined
costs of opioid use disorder and fatal
92 Luo, F., Li, M., & Florence, C. (2021). StateLevel Economic Costs of Opioid Use Disorder and
Fatal Opioid Overdose—United States, 2017.
MMWR. Morbidity and mortality weekly report,
70(15), 541–546. https://doi.org/10.15585/
mmwr.mm7015a1. See also https://
trumpwhitehouse.archives.gov/briefingsstatements/cea-report-underestimated-cost-opioidcrisis/ citing a Council of Economic Advisors study
estimating 2015 costs at $504 billion and a
Congressional study using the CDC methodology
estimating 2020 opioid crisis costs as $1.5 trillion.
See https://beyer.house.gov/news/
documentsingle.aspx.
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opioid overdose varied from $985
million in Wyoming to $72.6 billion in
Ohio. Per capita combined costs varied
from $1,204 in Hawaii to $7,247 in West
Virginia. States with high per capita
combined costs were located mainly in
the Ohio Valley and New England.
Across many studies, reduced quality of
life is the largest component of the cost
of opioid use disorder.93
A recent study showed that in the
absence of treatment, 42,717 overdoses
(4,132 fatal, 38,585 nonfatal) and 12,660
deaths were estimated to occur in a
cohort of 100,000 patients over 5
years.94 An estimated reduction in
overdoses was associated with
methadone treatment (10.7%),
buprenorphine or naltrexone treatment
(22.0%), and medication treatment
combined with psychotherapeutic
interventions (range, 21.0%–31.4%).95
Estimated decreased deaths were
associated with treatment with
methadone (6%), buprenorphine or
naltrexone (13.9%), and the
combination of medications and
psychotherapy (16.9%). When criminal
justice costs were included, all forms of
MOUD (with buprenorphine,
methadone, and naltrexone) were
associated with cost savings compared
with no treatment, yielding savings of
$25,000 to $105,000 in lifetime costs per
person.
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
93 Mitchell, S.G., Gryczynski, J., Schwartz, R.P.,
Myers, C.P., O’Grady, K.E., Olsen, Y.K., & Jaffe, J.H.
(2015). Changes in Quality of Life following
Buprenorphine Treatment: Relationship with
Treatment Retention and Illicit Opioid Use. Journal
of psychoactive drugs, 47(2), 149–157. https://
doi.org/10.1080/02791072.2015.1014948.
94 Fairley M, Humphreys K, Joyce VR, et al.
(2021). Cost-effectiveness of Treatments for Opioid
Use Disorder. JAMA Psychiatry. 2021;78(7):767–
777. doi:10.1001/jamapsychiatry.2021.0247.
95 McAdam-Marx C, Roland CL, Cleveland J,
Oderda GM (2010). Costs of opioid abuse and
misuse determined from a Medicaid database. J
Pain Palliat Care Pharmacother. 2010 Mar;24(1):5–
18. doi: 10.3109/15360280903544877. PMID:
20345194.
96 Murphy SM, Polsky D (2016). Economic
Evaluations of Opioid Use Disorder Interventions.
Pharmacoeconomics. 2016 Sep;34(9):863–87. doi:
10.1007/s40273–016–0400–5. PMID: 27002518;
PMCID: PMC5572804.
97 Baser O, Chalk M, Fiellin DA, Gastfriend DR
(2011). Cost and utilization outcomes of opioiddependence treatments. Am J Manag Care. 2011
Jun;17 Suppl 8:S235–48. PMID: 21761950.
98 Lynch FL, McCarty D, Mertens J, Perrin NA,
Green CA, Parthasarathy S, Dickerson JF, Anderson
BM, Pating D (2014). Costs of care for persons with
opioid dependence in commercial integrated health
systems. Addict Sci Clin Pract. 2014 Aug 14;9(1):16.
doi: 10.1186/1940–0640–9–16. PMID: 25123823;
PMCID: PMC4142137.
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7545
compared to beneficiaries matched by
age, gender, and state with no opioid
misuse diagnosis ($23,556 vs. $8,436; P
<0.001).95 The opioid dependence/
abuse group (using an older version of
the Diagnostic and Statistical Manual of
Mental Disorders) also had higher
prevalence of comorbidities, such as
psychiatric disorders, pain-related
diagnoses, and other substance use
conditions. While this study considered
overall cost, it did not address
medication costs in particular, or any
impact treatment may have had on
overall cost.
OTPs provide comprehensive
interventions including medications,
counseling and services designed to
offer a whole-person approach to care
and ameliorate social determinants of
health that contribute to substance
misuse. Numerous studies have
demonstrated that treatment with
pharmacotherapy and counseling
services can reduce overall healthcare
costs for patients with OUD.96 97 98 For
example, a 2019 analysis demonstrated
that a comprehensive approach to OUD
treatment is associated with improved
health and economic outcomes.99 This
study assessed patients with OUD
treated at a comprehensive primary care
center (CCP) and other Maryland
facilities in a large State Medicaid
program and demonstrated cost savings
with a comprehensive approach to care.
Compared to the non-CCP patient group
(n = 867), the CCP group (n = 131) had
a higher 6-month buprenorphine
treatment retention rate (P <0.001),
fewer hospital stays in the 12-month
follow-up period (P = 0.005), and lower
total cost (US$10,942 vs. $13,097, P
<0.001) and hospital stay cost
(US$1,448 vs. $4,265, P = 0.001).100
Other measures, including emergency
department utilization and cost,
substance use-related cost, and nonbuprenorphine 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
99 Hsu, Y.J., Marsteller, J.A., Kachur, S.G., &
Fingerhood, M.I. (2019). Integration of
Buprenorphine Treatment with Primary Care:
Comparative Effectiveness on Retention,
Utilization, and Cost. Population health
management, 22(4), 292–299. https://doi.org/
10.1089/pop.2018.0163.
100 Mohlman MK, Tanzman B, Finison K, Pinette
M, Jones C. Impact of Medication-Assisted
Treatment for Opioid Addiction on Medicaid
Expenditures and Health Services Utilization Rates
in Vermont. J Subst Abuse Treat. 2016 Aug; 67:9–
14. doi: 10.1016/j.jsat.2016.05.002. Epub 2016 May
9. PMID: 27296656.
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retention, fewer hospital stays, and
lower costs.
These findings are consistent with a
2016 cross sectional study that
evaluated medical claims for Vermont
Medicaid beneficiaries with opioid
dependence or addiction between 2008
and 2013. In their analysis, Mohlman
and colleagues determined that
medication combined with psychosocial
counseling is associated with reduced
general health care expenditures and
utilization, such as inpatient hospital
admissions and outpatient emergency
department visits, for Medicaid
beneficiaries with opioid misuse.100
Two prior studies assessed data from
commercial health insurance claims on
the overall health care costs and
utilization rates for those taking MOUD
compared to those treated without
MOUD.101 102 The first study found that
over a five-year period, members on
MOUD had 50% lower total annual
health plan costs than those who had
two or more visits to an addiction
treatment setting and no treatment, and
62% lower than those with zero or one
visit for addiction treatment and no
intervention.101 The other study found
that after a six-month period, those
taking MOUD had significantly lower
overall annual health plan costs
compared to those with no medication
($10,192 vs. $14,353; p-value <
0.0001).102 The difference was driven
largely by lower inpatient services and
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.
non-opioid-related outpatient services
for the group receiving medication.
The regulatory impact analysis (RIA)
outlined below, relies on data provided
to SAMHSA by OTP Accreditation
Bodies for the year 2020–2021. Pursuant
to 42 CFR part 8, Accreditation Bodies
and OTPs are required to submit
information to SAMHSA’s Center for
Substance Abuse Treatment (CSAT).
The annualized burden of information
collection for OTPs and Accreditation
Bodies under the rule is set forth in the
tables that follow.
This rule does not substantially alter
current reporting burden requirements,
or accreditation activities. The total
number of burden hours reported in
2020–2021 for Accreditation Body
respondents was approximately 394.70
hours. The total number of burden
hours for OTP respondents during the
same period was 1,868.95 hours. The
annual burden associated with this rule
and the associated forms was estimated
to be 2,263.65 hours.
b. Estimated Costs of Reporting Burdens
for OTPs and Accreditation Bodies
In developing its estimates of the
potential costs of the final regulation,
the Department relied substantially on
recent estimates of burden and cost
pertaining to requirements set forth in
42 CFR part 8.
Hourly labor costs involved in
reporting requirements vary greatly
Preparation
time
(hours)
Items
Total cost
Form SMA–163, compliance with the reporting requirements under 42 CFR 8.4 and 8.6 ........
Form SMA–162, compliance with other reporting requirements under 21 CFR 8.11, 8.24,
8.25, 8.26, and 8.28 .................................................................................................................
Form SMA–168, Exception Request and Record of Justification Under 42 CFR 8.11(h) ..........
394.2
$85.42
$33,672.56
188.95
2,135
85.42
85.42
16,140.11
182,371.70
Sub total ...............................................................................................................................
........................
........................
$232,184.37
c. Cost Pertaining to Record Keeping
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Cost/hour
The record-keeping requirements set
forth in 42 CFR 8.4 and 8.12 include
maintenance of the following: a
patient’s medical examination when
admitted to treatment; a patient’s
history; a care plan; any prenatal
support provided to the patient;
justification of unusually large initial
doses; changes in a patient’s dosage
schedule; the rationale for decreasing a
patient’s clinic attendance; services
provided; and documentation of
physiologic tolerance.
101 McCarty D, Perrin NA, Green CA, Polen MR,
Leo MC, Lynch F (2010). Methadone maintenance
and the cost and utilization of health care among
individuals dependent on opioids in a commercial
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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 or a cost
burden for these activities, nor did
commenters provide such information.
Costs Pertaining to Disclosure
The final rule includes requirements
that OTPs and accreditation
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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organizations disclose information. For
example, § 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
§ 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.
102 Baser O, Chalk M, Fiellin DA, Gastfriend DR.
(2011). Cost and utilization outcomes of opioiddependence treatments. Am J Manag Care. 2011
Jun;17 Suppl 8:S235–48. PMID: 21761950.
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e. Estimate of Annualized Non-Hourly
Cost Burden to Respondents
The final rule does not impose new
capital or startup costs beyond the
normal office and laboratory equipment
required for achieving regulatory
compliance. It is estimated that there are
some costs associated with preparation
for the accreditation site visit itself;
assuming that OTP staff spend
approximately 180 hours preparing for
the site visit at an average cost of $85.42
per hour and an average of 1.33 site
visits per facility, the total cost would
be $20,450 or an annualized cost of
$15,376 per facility. For the current
approximately 2,000 affected OTPs
these total annual costs are estimated to
be $30,752,000. The percentage of this
total cost that is associated with record
keeping and reporting-only is difficult
to estimate, but it is considered to be a
small fraction of the total associated
with accreditation.
i. Estimate of Annualized Cost to the
Government
The total annualized cost to SAMHSA
for administering 42 CFR part 8 is
estimated at $450,000. This estimate
includes the cost of an outside
contractor to develop and maintain an
7547
extensive on-line protected website for
day-to-day regulatory activities that can
be used by SAMSHA, opioid treatment
programs, State Opioid Treatment
Authorities, Accreditation Bodies and
other stakeholders. This estimate does
not include funds that SAMHSA/Center
for Substance Abuse Treatment (CSAT)
allocates to its ‘‘look back’’ program that
monitors the adequacy of accreditation
surveys. Of this amount, the total
annualized cost to SAMHSA for
Paperwork Reduction Act activities as a
result of this regulation is estimated as
$221,434, as shown in the following
table.
ANNUALIZED COST TO SAMHSA/CSAT
Item
(purpose)
Responses
Total
hours
Total cost@
$85.42 per
hour
SMA–162 (New Programs) ..............................................................................
SMA–162 (Renewal) ........................................................................................
SMA–162 (Relocation) .....................................................................................
Notification of Provisional Certification ............................................................
Notification of Extension of Provisional Certification .......................................
Notification of Sponsor or Medical Director Change .......................................
Documentation to SAMHSA for Interim Treatment .........................................
Requests to SAMHSA for Exemption from §§ 8.11 and 8.12 (including
SMA–168) ....................................................................................................
Notification to SAMHSA Before Establishing Medication Units ......................
Review of Submissions under Part C ..............................................................
Accreditation Body Initial Application (SMA–163) ...........................................
Accreditation Body Renewal (SMA–163) ........................................................
Relinquishment Notification .............................................................................
Notification for Serious Non-Compliant Programs ...........................................
General Documents to SAMHSA Upon Request ............................................
Accreditation Survey to SAMHSA Upon Request ...........................................
Less Than Full Accreditation Report to SAMHSA ...........................................
Summaries of Inspections ...............................................................................
Notification of Complaints to SAMHSA ...........................................................
Submission of 90-Day Corrective Plan to SAMHSA .......................................
42
386
35
40
15
60
1
1.5
.75
.25
.50
.50
0.33
0.50
63
289.5
8.75
20
7.5
19.8
0.5
$5,381
24,729
747
1,708
641
1,691
43
24,000
20
2
3
3
1
2
10
383
10
12
10
1
0.07
1.00
2.00
40
40
.50
.50
1.00
.50
1.00
1.00
1.00
4.25
1680
20
4
120
120
0.5
1
10
191.5
10
12
10
4.25
143,506
1,708
342
10,250
10,250
43
85
854
16,358
854
1,025
854
363
Sub total ...................................................................................................
25,03625,036
97.15
2592.3
221,434
2. Consideration of Regulatory
Alternatives
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Hours per
response
The Department has completed
rulemaking to make flexibilities issued
during the COVID–19 PHE permanent,
while also updating accreditation and
treatment standards to reflect evidencebased practices and current medical
terminology and approaches to OUD
treatment given the current overdose
crisis. The alternative would be to allow
the current flexibilities to lapse with the
end of the COVID–19 PHE, or to renew
them periodically as may be needed
during future emergencies or changed
circumstances. This is considered to be
suboptimal as it creates uncertainty
among patients and OTPs, while also
constraining access to care. Rulemaking,
on the other hand, allows OTPs and
their patients to operate in a stable and
regulated environment that promotes
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access to evidence-based interventions.
Other changes in the rule impact
Accreditation Body oversight and
procedures. Such changes can only be
effectuated in a regulatory setting.
B. Regulatory Flexibility Act
The Department has examined the
economic implications of this final rule
as required by the Regulatory Flexibility
Act (5 U.S.C. 601–612). If a rule has a
significant economic impact on a
substantial number of small entities, the
Regulatory Flexibility Act (RFA)
requires agencies to analyze regulatory
options that would lessen the economic
effect of the rule on small entities. For
purposes of the RFA, small entities
include small businesses, nonprofit
organizations, and small governmental
jurisdictions. The Act defines ‘‘small
entities’’ as (1) a proprietary firm
meeting the size standards of the Small
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Business Administration (SBA), (2) a
nonprofit organization that is not
dominant in its field, and (3) a small
government jurisdiction of less than
50,000 population. Because 90 percent
or more of all health care providers meet
the SBA size standard for a small
business or are nonprofit organizations,
the Department generally treats all
health care providers as small entities
for purposes of performing a regulatory
flexibility analysis. The SBA size
standard for health care providers
ranges between a maximum of $8
million and $41.5 million in annual
receipts, depending upon the type of
entity.
Pursuant to the RFA (5 U.S.C. 601–
612), the Department asserts a factual
basis for its certification that the rule
will not have a significant economic
impact on a substantial number of small
entities. As discussed in the Regulatory
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Impact Analysis (RIA) the costs
associated with compliance are
minimal. As such, the Department
certifies that the proposed rule will not
impose a significant economic impact.
The RIA contains the factual details
supporting this certification, affirming
the conclusion that the financial impact
of compliance is insubstantial in
relation to the affected entities’ financial
operations.
C. Unfunded Mandates Reform Act
Section 202(a) of The Unfunded
Mandates Reform Act of 1995 (UMRA)
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
that may result in expenditures in any
one year of $100 million in 1995 dollars,
updated annually for inflation. As of
2023, this threshold is $165 million.
The Department does not anticipate that
this final rule would result in the
expenditure by State, local, and Tribal
governments, taken together, or by the
private sector, of $165 million or more
in any one year.
D. Executive Order 13132—Federalism
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a final
rule that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has federalism implications.
The Department does not believe that
this rulemaking would have any
significant federalism implications,
impose significant costs on State or
local governments or preempt State law.
E. Assessment of Federal Regulation
and Policies on Families
Section 654 of the Treasury and
General Government Appropriations
Act of 1999 103 requires Federal
departments and agencies to determine
whether a policy or regulation could
affect family well-being. If the
determination is affirmative, then the
Department or agency must prepare an
impact assessment to address criteria
specified in the law. The Department
believes that the final regulations would
positively impact the ability of patients
and families to access treatment for
OUD. The Department does not
anticipate negative impacts on family
well-being as a result of this rule.
F. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (PRA) (Pub. L. 104–13), agencies
are required to submit to the Office of
Management and Budget (OMB) for
review and approval any reporting or
recordkeeping requirements inherent in
a proposed or final rule, and are
required to publish such requirements
for public comment. The PRA requires
agencies to provide a 60-day notice in
the Federal Register and solicit public
comment on a proposed collection of
information before it is submitted to
OMB for review and approval. To fairly
evaluate whether an information
collection should be approved by OMB,
section 3506(c)(2)(A) of the PRA
requires that the Department solicit
comment on the following issues:
1. Whether the information collection
is necessary and useful to carry out the
proper functions of the agency;
2. The accuracy of the agency’s
estimate of the information collection
burden;
3. The quality, utility, and clarity of
the information to be collected; and
4. Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
The PRA requires consideration of the
time, effort, and financial resources
necessary to meet the information
collection requirements referenced in
this section. The Department explicitly
sought public comment on its
assumptions as they relate to the PRA
requirements summarized in this
section. No applicable comments were
received.
As discussed below, the Department
estimates a total OTP burden associated
with all information collections of
1,868.95 hours, and a total number of
burden hours for Accreditation Body
respondents of approximately 394.70
hours each year. The annual burden
associated with this rule and the
associated forms is therefore estimated
to be 2,263.65 hours.
1. Explanation of Estimated Annualized
Burden Hours for 42 CFR Part 8
The Department presents, in separate
tables below, burden estimates for the
annual reporting requirement for
Accreditation Bodies and OTPs
pursuant to the final rule.
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR ACCREDITATION BODIES
Purpose
8.3(b)(1) through (11) ..
8.3(c) ...........................
8.3(e) ...........................
8.3(f)(2) ........................
Initial approval (SMA–163) ........
Renewal of approval (SMA–163)
Relinquishment notification ........
Non-renewal notification to accredited OTPs.
Notification to SAMHSA for seriously noncompliant OTPs.
Notification to OTP for serious
noncompliance.
General documents and information to SAMHSA upon request.
Accreditation
survey
to
SAMHSA upon request.
List of surveys, surveyors to
SAMHSA upon request.
Report of less than full accreditation to SAMHSA.
Summaries of Inspections .........
Notifications of Complaints ........
8.4(b)(1)(ii) ...................
8.4(b)(1)(iii) ..................
8.4(d)(1) .......................
8.4(d)(2) .......................
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Number of
respondents
42 CFR citation
8.4(d)(3) .......................
8.4(d)(4) .......................
8.4(d)(5) .......................
8.4(e) ...........................
Responses/
respondent
Total
responses
Hours/
response
1
2
1
1
1
1
1
90
1
2
1
90
6.0
1.0
0.5
0.1
6
2
0.5
9
2
2
4
1.0
4
2
10
20
1.0
20
6
5
30
0.5
15
6
75
450
0.02
9
6
6
36
0.2
7.2
6
5
30
0.5
15
6
12
50
6
300
72
0.5
0.5
150
36
103 Public Law 105–277, 112 Stat. 2681 (October
21, 1998).
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ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR ACCREDITATION BODIES—Continued
Number of
respondents
42 CFR citation
Purpose
8.6(a)(2) and (b)(3) ......
Revocation notification to Accredited OTPs.
Submission of 90-day corrective
plan to SAMHSA.
Notification to accredited OTPs
of Probationary Status.
8.6(b) ...........................
8.6(b)(1) .......................
Sub total ...............
....................................................
Responses/
respondent
Total
responses
Hours/
response
Total
hours
1
185
185
0.3
55.5
1
1
1
10
10.0
1
185
185
0.3
55.5
54
........................
1,407
........................
394.70
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR OPIOID TREATMENT PROGRAMS
Purpose
8.11(b) .........................
8.11(b) .........................
Renewal of approval (SMA–162)
Relocation of Program (SMA–
162).
Application for provisional certification.
Application for extension of provisional certification.
Notification of sponsor or medical director change (SMA–
162).
Documentation to SAMHSA for
interim treatment.
Request to SAMHSA for Exemption from §§ 8.11 and
8.12 (including SMA–168).
Notification to SAMHSA Before
Establishing Medication Units
(SMA–162).
Notification to State Opioid
Treatment Authority For Interim Treatment.
Contents of Appellant Request
for Review of Suspension.
Informal Review Request ...........
Appellant’s Review File and
Written Statement.
Appellant’s Request for Expedited Review.
Appellant Review File and Written Statement.
8.11(d) .........................
8.11(f) ..........................
8.11(g)(5) .....................
8.11(h)(2) .....................
8.11(i) ..........................
8.11(j)(1) ......................
8.12(j)(2) ......................
8.24 ..............................
8.25(a) .........................
8.26(a) .........................
8.28(a) .........................
8.28(c) .........................
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Number of
respondents
42 CFR citation
Responses/
respondent
Total
responses
Hours/
response
Total
hours
386
35
1
1
386
35
0.15
1.17
57.9
40.95
42
1
42
1
42.00
30
1
30
0.25
7.50
60
1
60
0.1
6.00
1
1
1
1
1.00
1,200
20
24,000
0.07
1,680
10
1
10
0.25
2.5
1
20
20
0.33
6.6
2
1
2
0.25
.50
2
2
1
1
2
2
1.00
5.00
2.00
10.00
2
1
2
1.00
2.00
2
1
2
5.00
10.00
Sub total ...............
....................................................
1,775
........................
24,594
........................
1,868.95
Total ..............
....................................................
1,829
........................
26,001
........................
2,263.65
The tables above reflect current
estimates of burden, as the final rule
does not effectively add or alter new
reporting requirements. The estimates
are derived from SAMHSA’s data and
are reflective of work from over the
preceding eighteen months. Further to
this, the estimates of burden do not
substantially differ from previously
submitted estimates provided to The
Office of Management and Budget.
Recognizing the importance of
expanding access to care, the
Department has been careful to limit
additional burden.
The final rule does not alter reporting
requirements as these have been shown
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to be effective in the safe administration
of OTPs. The accreditation system
provides effective oversight, while OTP
reporting requirements support
accreditation activities and the
provision of safe treatment. Further to
this, the final rule retains requirements
that OTP’s and accreditation
organizations disclose information
related to patient care and clinic
policies and procedures for the
treatment of OUD with MOUD. For
example, § 8.12(e)(1) requires that a
health care practitioner explain the facts
concerning the use of MOUD to each
patient. This type of disclosure is
considered to be consistent with
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common medical practice and is not
considered an additional burden.
Further, the requirement under
§ 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.
For the reasons stated in the preamble,
the Department of Health and Human
■
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Federal Register / Vol. 89, No. 23 / Friday, February 2, 2024 / Rules and Regulations
Services revises 42 CFR part 8 to read
as set forth below:
PART 8—MEDICATIONS FOR THE
TREATMENT OF OPIOID USE
DISORDER
Subpart A—General Provisions
Sec.
8.1 Scope.
8.2 Definitions.
Subpart B—Accreditation of Opioid
Treatment Programs
8.3 Application for approval as an
Accreditation Body.
8.4 Accreditation Body responsibilities.
8.5 Periodic evaluation of Accreditation
Bodies.
8.6 Withdrawal of approval of
Accreditation Bodies.
Subpart C—Certification and Treatment
Standards for Opioid Treatment Programs
8.11 Opioid Treatment Program
certification.
8.12 Federal Opioid Use Disorder treatment
standards.
8.13 Revocation of accreditation and
Accreditation Body approval.
8.14 Suspension or revocation of
certification.
8.15 Forms.
Subpart D—Procedures for Review of
Suspension or Proposed Revocation of
OTP Certification, and of Adverse Action
Regarding Withdrawal of Approval of an
Accreditation Body
8.21 Applicability.
8.22 Definitions.
8.23 Limitation on issues subject to review.
8.24 Specifying who represents the parties.
8.25 Informal review and the reviewing
official’s response.
8.26 Preparation of the review file and
written arguments.
8.27 Opportunity for oral presentation.
8.28 Expedited procedures for review of
immediate suspension.
8.29 Ex parte communications.
8.30 Transmission of written
communications by reviewing official
and calculation of deadlines.
8.31 Authority and responsibilities of the
reviewing official.
8.32 Administrative record.
8.33 Written decision.
8.34 Court review of final administrative
action; exhaustion of administrative
remedies.
Subpart E [Reserved]
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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
§ 8.1
Scope.
(a) Scope. This subpart and subparts
B through D of this part establish the
procedures by which the Secretary of
Health and Human Services (the
Secretary) will determine whether an
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applicant seeking to become an Opioid
Treatment Program (OTP) is qualified
under section 303(h) of the Controlled
Substances Act (CSA) (21 U.S.C. 823(h))
to dispense Medications for Opioid Use
Disorder (MOUD) in the treatment of
Opioid Use Disorder (OUD), and
establishes the Secretary’s standards
regarding the appropriate quantities of
MOUD that may be provided for
unsupervised use by individuals
undergoing such treatment (21 U.S.C.
823(h)). Under this subpart and subparts
B through D, an applicant seeking to
become an OTP must first obtain from
the Secretary or, by delegation, from the
Assistant Secretary for Mental Health
and Substance Use, a certification that
the applicant is qualified under the
Secretary’s standards and will comply
with such standards. Eligibility for
certification will depend upon the
applicant obtaining accreditation from
an Accreditation Body that has been
approved by the Secretary. This subpart
and subparts B through D also establish
the procedures whereby an entity can
apply to become an approved
Accreditation Body, and the
requirements and general standards for
Accreditation Bodies to ensure that
OTPs are consistently evaluated for
compliance with the Secretary’s
standards for treatment of OUD with
MOUD.
(b) Severability. Any provision of this
part held to be invalid or unenforceable
by its terms, or as applied to any person
or circumstance, or stayed pending
further agency action, shall be construed
so as to give it the maximum effect
permitted by law, unless such holding
shall be one of utter invalidity or
unenforceability, in which event such
provision shall be severable from this
part and shall not affect the remainder
thereof or the application of the
provision to persons not similarly
situated or to dissimilar circumstances.
§thnsp;8.2
Definitions.
The following definitions apply to
this part:
Accreditation Body or ‘‘the Body’’
means an organization that has been
approved by the Secretary in this part to
accredit OTPs dispensing MOUD.
Accreditation Body application means
the application filed with the Secretary
for purposes of obtaining approval as an
Accreditation Body, as described in
§ 8.3(b).
Accreditation elements mean the
elements or standards that are
developed and adopted by an
Accreditation Body and approved by the
Secretary.
Accreditation survey means an onsite
or virtual review and evaluation of an
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OTP by an Accreditation Body for the
purpose of determining compliance
with the Federal opioid use disorder
treatment standards described in § 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
§ 8.3(d).
Behavioral health services means any
intervention carried out in a therapeutic
context at an individual, family, or
group level. Interventions may include
structured, professionally administered
clinical interventions (e.g., cognitive
behavior therapy or insight-oriented
psychotherapy) delivered in-person, or
remotely via telehealth or telemedicine,
which has been shown to facilitate
treatment outcomes, or non-clinical
interventions.
Care plan means an individualized
treatment and/or recovery plan that
outlines attainable treatment goals that
have been identified and agreed upon
between the patient and the OTP
clinical team, and which specifies the
services to be provided, as well as the
proposed frequency and schedule for
their provision.
Certification means the process by
which the Secretary determines that an
OTP is qualified to provide OUD
treatment under the Federal Opioid Use
Disorder treatment standards.
Certification application means the
application filed by an OTP for
purposes of obtaining certification from
the Secretary, as described in § 8.11(b).
Certified opioid treatment program
means an OTP that is the subject of a
current, valid certification under § 8.11.
Comprehensive treatment is treatment
that includes the continued use of
MOUD provided in conjunction with an
individualized range of appropriate
harm reduction, medical, behavioral
health, and recovery support services.
Conditional certification is a type of
temporary certification granted to an
OTP that has requested renewal of its
certification and that has received
temporary accreditation for one year by
an approved Accreditation Body. The
one-year accreditation period is to allow
the OTP to address areas of significant
non-conformance with accreditation
standards that do not involve
immediate, high-risk health and/or
safety concerns.
Continuous medication treatment
means the uninterrupted treatment for
OUD involving the dispensing and
administration of MOUD at stable
dosage levels for a period in excess of
21 days.
Dispense means to deliver a
controlled medication to an ultimate
user by, or pursuant to, the lawful order
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of, a practitioner, including the
prescribing and administering of a
controlled medication.
Diversion control plan means a set of
documented procedures that reduce the
possibility that controlled medications
will be transferred or otherwise shared
with others to whom the medication
was not prescribed or dispensed.
Federal Opioid Use Disorder
treatment standards means the
standards established by the Secretary
in § 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 § 8.12 also include the
standards established by the Secretary
regarding the quantities of MOUD
which may be provided for
unsupervised, take-home use.
For-cause inspection means an
inspection, by the Secretary, an
Accreditation Body, or a State authority,
of an OTP that may be operating in
violation of Federal Opioid Use
Disorder treatment standards, may be
providing substandard treatment, may
be serving as a possible source of
diverted medications, or where patient
well-being is at risk.
Harm reduction refers to practical and
legal evidence-based strategies,
including: overdose education; testing
and intervention for infectious diseases,
including counseling and risk
mitigation activities forming part of a
comprehensive, integrated approach to
address human immunodeficiency virus
(HIV), viral hepatitis, sexually
transmitted infections, and bacterial and
fungal infections; distribution of opioid
overdose reversal medications; linkage
to other public health services; and
connecting those who have expressed
interest in additional support to peer
services.
Individualized dose means the dose of
a medication for opioid use disorder,
ordered by an OTP practitioner and
dispensed to a patient, that sufficiently
suppresses opioid withdrawal
symptoms. Individualized doses may
also include split doses of a medication
for opioid use disorder, where such
dosing regimens are indicated.
Interim treatment means that on a
temporary basis, a patient may receive
some services from an OTP, while
awaiting access to more comprehensive
treatment services. The duration of
interim treatment is limited to 180 days.
Long-term care facilities mean those
facilities that provide rehabilitative,
restorative, and/or ongoing services to
those in need of assistance with
activities of daily living. Long-term care
facilities include: extended acute care
facilities; rehabilitation centers; skilled
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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 nonphysician practitioners with
prescriptive authority functioning under
the medical director’s supervision, or
appropriately licensed and/or
credentialed non-physician healthcare
professionals providing services in the
OTP, in compliance with applicable
Federal and State laws. Such
delegations will not eliminate the
medical director’s responsibility for all
medical and behavioral health services
provided by the OTP.
Medication for Opioid Use Disorder or
MOUD means medications, including
opioid agonist medications, approved
by the Food and Drug Administration
under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355),
for use in the treatment of OUD. As used
in this part, ‘‘continuous medication
treatment’’ is intended to be
synonymous with the term
‘‘maintenance’’ treatment as used in 21
U.S.C. 823(h)(1), and the term
‘‘withdrawal management’’ is intended
to be synonymous with the term
‘‘detoxification’’ as used in 21 U.S.C.
823(h)(1).
Medication unit means an entity that
is established as part of, but
geographically separate from, an OTP
from which appropriately licensed OTP
practitioners, contractors working on
behalf of the OTP, or community
pharmacists may dispense or administer
MOUD, collect samples for drug testing
or analysis, or provide other OTP
services. Medication units can be a
brick-and-mortar location or mobile
unit.
Nationally recognized evidence-based
guidelines mean a document produced
by a national or international medical
professional association, public health
agency, such as the World Health
Organization, or governmental body
with the aim of assuring the appropriate
use of evidence to guide individual
diagnostic and therapeutic clinical
decisions for the management of OUD
and other health conditions that are
widely recognized within the United
States.
Opioid Treatment Program or OTP
means a program engaged in OUD
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treatment of individuals with MOUD
registered under 21 U.S.C. 823(h)(1).
Opioid Treatment Program
certification means the process by
which the Secretary determines that an
OTP applicant is qualified to provide
Opioid Use Disorder treatment under
the Federal Opioid Use Disorder
treatment standards described in § 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 12month period.
Opioid Use Disorder treatment means
the dispensing of MOUD, along with the
provision of a range of medical and
behavioral health services, as clinically
necessary and based on an
individualized assessment and a
mutually agreed-upon care plan, to an
individual to alleviate the combination
of adverse medical, psychological, or
physical effects associated with an
OUD.
Patient, for purposes of this part,
means any individual who receives
continuous treatment or withdrawal
management in an OTP.
Physical and behavioral health
services include services such as
medical and psychiatric screening,
assessments, evaluations, examinations,
and interventions, counseling, health
education, peer support services, and
social services (e.g., vocational and
educational guidance, employment
training), that are intended to help
patients receiving care in OTPs achieve
and sustain remission and recovery.
Practitioner, for purposes of this part,
means a health care professional who is
appropriately licensed by a State to
prescribe and/or dispense medications
for opioid use disorders and, as a result,
is authorized to practice within an OTP.
Program sponsor means the person
named in the application for
certification described in § 8.11(b) as
responsible for the operation of the OTP
and who assumes responsibility for all
its employees, including any
practitioners, agents, or other persons
providing medical, behavioral health, or
social services at the program or any of
its medication units. The program
sponsor need not be a licensed
physician but shall ensure that an
actively licensed physician occupies the
position of medical director within an
OTP.
Recovery support services means:
(1) Recovery is the process of change
through which people improve their
health and wellness, live self-directed
lives, and strive to reach their full
potential.
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(2) Recovery support services can
include, but are not limited to,
community-based recovery housing,
peer recovery support services, social
support, linkage to and coordination
among allied service providers and a
full range of human services that
facilitate recovery and wellness
contributing to an improved quality of
life. The services extend the continuum
of care by strengthening and
complementing substance use disorder
(SUD) treatment interventions in
different settings and stages.
Split dosing means dispensing of a
single dose of MOUD as separate
portions to be taken within a 24-hour
period. Split dosing is indicated among,
but not limited to, those patients who:
possess a genetic variant which
increases methadone metabolism;
concurrently take other medications or
drink alcohol that also induce hepatic
enzymes leading to more rapid
metabolism of methadone; who are
pregnant; or for whom methadone or
buprenorphine are being used to treat a
concurrent pain indication in addition
to the diagnosis of OUD. This leads to
more stable, steady-state medication
levels.
State Opioid Treatment Authority
(SOTA) is the agency designated by the
Governor of a State, or other appropriate
official designated by the Governor, to
exercise the responsibility and authority
within the State or Territory for
governing the treatment of OUD with
MOUD in OTPs.
Telehealth or telemedicine, for
purposes of this part, is the delivery and
facilitation of health and health-related
services including medical care,
counseling, practitioner, provider and
patient education, health information
services, and self-care via
telecommunications and digital
communication technologies. This
includes Health Insurance Portability
and Accountability Act (HIPAA)compliant video and audio-only
communication platforms.
Withdrawal management means the
dispensing of a MOUD in decreasing
doses to an individual to alleviate
adverse physical effects incident to
withdrawal from the continuous or
sustained use of an opioid and as a
method of bringing the individual to an
opioid-free state within such period.
Long-term withdrawal management
refers to the process of medication
tapering that exceeds 30 days.
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Subpart B—Accreditation of Opioid
Treatment Programs
§ 8.3 Application for approval as an
Accreditation Body.
(a) Eligibility. Private nonprofit
organizations, State or territorial
governmental entities, or political
subdivisions thereof, and Indian Tribes
as defined by the Federally Recognized
Indian Tribe List Act of 1994, that are
capable of meeting the requirements of
this part may apply for approval as an
Accreditation Body.
(b) Application for initial approval.
Electronic copies of an Accreditation
Body application form [SMA–167] shall
be submitted to: https://
dpt2.samhsa.gov/sma163/.
Accreditation Body applications shall
include the following information and
supporting documentation:
(1) Name, address, and telephone
number of the applicant and a
responsible official for the Accreditation
Body. The application shall be signed
by the responsible official;
(2) Evidence of the nonprofit status of
the applicant (i.e., of fulfilling Internal
Revenue Service requirements as a
nonprofit organization) if the applicant
is not a State or territorial governmental
entity, Indian Tribe, or political
subdivision;
(3) A set of the accreditation elements
or standards and a detailed discussion
showing how the proposed
accreditation elements or standards will
ensure that each OTP surveyed by the
applicant is qualified to meet or is
meeting each of the Federal opioid use
disorder treatment standards set forth in
§ 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
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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 § 8.4, including a contingency plan
for investigating complaints under
§ 8.4(e);
(10) Policies and procedures
established to protect confidential
information the applicant will collect or
receive in its role as an Accreditation
Body; and
(11) Any other supporting information
the Secretary may require.
(c) Application for renewal of
approval. An Accreditation Body that
intends to continue to serve as an
Accreditation Body beyond its current
term shall apply to the Secretary for
renewal, or notify the Secretary of its
intention not to apply for renewal, in
accordance with the following
procedures and schedule:
(1) At least 9 months before the date
of expiration of an Accreditation Body’s
term of approval, the Body shall inform
the Secretary in writing of its intent to
seek renewal.
(2) The Secretary will notify the
applicant of the relevant information,
materials, and supporting
documentation required under
paragraph (b) of this section that the
applicant shall submit as part of the
renewal procedure.
(3) At least 3 months before the date
of expiration of the Accreditation
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Body’s term of approval, the applicant
shall send to the Secretary electronically
a renewal application containing the
information, materials, and supporting
documentation requested by the
Secretary under paragraph (c)(2) of this
section.
(4) An Accreditation Body that does
not intend to renew its approval shall so
notify the Secretary at least 9 months
before the expiration of the Body’s term
of approval.
(d) Rulings on applications for initial
approval or renewal of approval. (1) The
Secretary will grant an application for
initial approval or an application for
renewal of approval if it determines the
applicant substantially meets the
Accreditation Body requirements of this
subpart.
(2) If the Secretary determines that the
applicant does not substantially meet
the requirements set forth in this
subpart, the Secretary will notify the
applicant of the deficiencies in the
application and request that the
applicant resolve such deficiencies
within 90 days of receipt of the notice.
If the deficiencies are resolved to the
satisfaction of the Secretary within the
90-day time period, the Body will be
approved as an Accreditation Body. If
the deficiencies have not been resolved
to the satisfaction of the Secretary
within the 90-day time period, the
application for approval as an
Accreditation Body will be denied.
(3) If the Secretary does not reach a
final decision on a renewal application
before the expiration of an Accreditation
Body’s term of approval, the approval
will be deemed extended until the
Secretary reaches a final decision,
unless an Accreditation Body does not
rectify deficiencies in the application
within the specified time period, as
required in paragraph (d)(2) of this
section.
(e) Relinquishment of approval. An
Accreditation Body that intends to
relinquish its accreditation approval
before expiration of the Body’s term of
approval shall submit a letter of such
intent to the Secretary, at the address in
paragraph (b) of this section, at least 9
months before relinquishing such
approval.
(f) Notification. An Accreditation
Body that does not apply for renewal of
approval, or is denied such approval by
the Secretary, relinquishes its
accreditation approval before expiration
of its term of approval, or has its
approval withdrawn, shall:
(1) Transfer copies of records and
other related information as required by
the Secretary to a location, including
another Accreditation Body, and
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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.
§ 8.4
Accreditation Body responsibilities.
(a) Accreditation surveys and for
cause inspections. (1) Accreditation
Bodies shall conduct routine
accreditation surveys for initial
accreditation, and then at least every
three years to allow for renewal of
certification.
(2) Accreditation Bodies must agree to
conduct for-cause inspections upon the
request of the Secretary.
(3) Accreditation decisions shall be
fully consistent with the policies and
procedures submitted as part of the
approved Accreditation Body
application.
(b) Response to noncompliant
programs. (1) If an Accreditation Body
receives or discovers information that
suggests that an OTP is not meeting
applicable accreditation or certification
standards established or authorized
under this part, or if a survey of the OTP
by the Accreditation Body demonstrates
that such standards are not being met,
the Accreditation Body shall, within 60
days following discovery of the noncompliant condition(s) or applicable
survey date:
(i) Provide written notice to the OTP
that identifies each area of noncompliance, categorizes each noncompliant condition as either ‘‘minor’’
or ‘‘significant’’ as determined by the
Accrediting Body, and requires the OTP
to take corrective action to address the
area(s) of non-compliance within a
schedule, not to exceed 180 days, that
the Accrediting Body deems appropriate
based on the severity of the noncompliant conditions; and
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(ii) Provide the Secretary with a copy
of the written notice required under
paragraph (b)(1)(i) of this section.
(2) Once an Accreditation Body
provides an OTP with the notice
described in paragraph (b)(1)(i) of this
section, it shall verify the
implementation of the corrective
measures by the OTP within the
specified schedule. Within 30 days
following the last day of the specified
schedule, the Accreditation Body shall
provide written notice to the Secretary
regarding whether the OTP has
implemented the corrective measures.
(3) OTPs that are meeting the
requirements of § 8.12, but are only
required to correct minor non-compliant
conditions shall be granted a three-year
accreditation, beginning from the end
date of the current and expiring
accreditation period. Minor noncompliant conditions, found at the time
of the survey that are not resolved, as
determined by the Accreditation Body,
within the OTP’s three-year
accreditation period and that remain
areas of non-compliance during the
OTP’s subsequent three-year
accreditation renewal survey, shall
automatically be categorized as
‘‘significant’’ non-compliant conditions
for purposes of the renewal survey and
must be corrected in accordance with
paragraph (b)(1)(i) of this section.
(4) OTPs that are required to correct
significant non-compliant conditions
shall be granted a one-year
accreditation, beginning from the end
date of the current and expiring
accreditation period. An OTP’s
accreditation must be revoked if it fails
to correct significant non-compliant
conditions within the schedule
provided under paragraph (b)(1)(i) of
this section. If an Accrediting Body
verifies that an OTP has corrected the
significant non-compliant conditions
identified within the specified schedule,
it shall extend the OTP’s accreditation
period by an additional two years.
(5) In cases of severe non-compliance
with the requirements of § 8.12 that
pose immediate risks to patient health
and safety, the Accreditation Body shall
inform the OTP and Secretary within 48
hours and provide a detailed written
report of the non-compliance within 5
business days. The Accreditation Body
shall give the OTP 30 days from the date
of the non-compliance report to correct
the non-compliance issue(s). A followup survey shall be conducted by the
Accreditation Body within 30 days of
the expected correction date to ensure
successful remediation. Should the OTP
not rectify the non-compliance within
the 30-day period, the Accreditation
Body shall revoke the OTP’s
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accreditation. The Secretary will then
make a decision regarding the OTP’s
certification in accordance with the
procedures under § 8.13.
(c) Recordkeeping. (1) Accreditation
Bodies shall maintain, and make
available as requested by the Secretary,
records of their accreditation activities
for at least 5 years from the creation of
the record. Such records must contain
sufficient detail to support each
accreditation decision made by the
Accreditation Body.
(2) Accreditation Bodies shall
establish procedures to protect
confidential information collected or
received in their role as Accreditation
Bodies that are consistent with, and that
are designed to ensure compliance with,
all Federal and State laws, including 42
CFR part 2.
(i) Information collected or received
for the purpose of carrying out
Accreditation Body responsibilities
shall not be used for any other purpose
or disclosed, other than to the Secretary
or its duly designated representatives,
unless otherwise required by law or
with the consent of the OTP.
(ii) Nonpublic information that the
Secretary shares with the Accreditation
Body concerning an OTP shall not be
further disclosed except with the
written permission of the Secretary.
(d) Reporting. (1) Accreditation
Bodies shall provide to the Secretary
any documents and information
requested by the Secretary within 5 days
of receipt of the request.
(2) Accreditation Bodies shall submit
a summary of the results of each
accreditation survey to the Secretary
within 90 days following the survey
visit. Such summaries shall contain
sufficient detail to justify the
accreditation action taken.
(3) Accreditation Bodies shall provide
the Secretary a list of each OTP
surveyed, and the identity of all
individuals involved in the conducting
and reporting of survey results.
(4) Accreditation Bodies shall submit
to the Secretary the name of each OTP
for which the Accreditation Body
accredits conditionally, denies,
suspends, or revokes accreditation, and
the basis for the action, within 48 hours
of the action.
(5) Notwithstanding any reports made
to the Secretary under paragraphs (d)(1)
through (4) of this section, each
Accreditation Body shall submit to the
Secretary semiannually, on January 15
and July 15 of each calendar year, a
report consisting of a summary of the
results of each accreditation survey
conducted in the past year. The
summary shall contain sufficient detail
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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
§ 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 § 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 noncompliance 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
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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.
§ 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 § 8.6.
§ 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.
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(1) In the event of a major deficiency,
the Secretary shall notify the
Accreditation Body of the agency’s
action and the grounds on which the
approval was withdrawn.
(2) An Accreditation Body that has
lost its approval shall notify each OTP
that has been accredited or is seeking
accreditation that the Accreditation
Body’s approval has been withdrawn.
Such notification shall be made within
a time period and in a manner approved
by the Secretary.
(b) Minor deficiencies. If the Secretary
determines that the Accreditation Body
has minor deficiencies in the
performance of an accreditation
function, that are less serious or more
limited than the types of deficiencies
described in paragraph (a) of this
section, the Secretary will notify the
Body that it has 90 days to submit to the
Secretary a plan of corrective action.
The plan must include a summary of
corrective actions and a schedule for
their implementation. The Secretary
may place the Body on probationary
status for a period of time determined
by the Secretary, or may withdraw
approval of the Body if corrective action
is not taken.
(1) If the Secretary places an
Accreditation Body on probationary
status, the Body shall notify all OTPs
that have been accredited, or that are
seeking accreditation, of the
Accreditation Body’s probationary
status within a time period and in a
manner approved by the Secretary.
(2) Probationary status will remain in
effect until such time as the Body can
demonstrate to the satisfaction of the
Secretary that it has successfully
implemented or is implementing the
corrective action plan within the
established schedule, and the corrective
actions taken have substantially
eliminated all identified problems.
(3) If the Secretary determines that an
Accreditation Body that has been placed
on probationary status is not
implementing corrective actions
satisfactorily or within the established
schedule, the Secretary may withdraw
approval of the Accreditation Body. The
Accreditation Body shall notify all OTPs
that have been accredited, or are seeking
accreditation, of the Accreditation
Body’s loss of the Secretary’s approval
within a time period and in a manner
approved by the Secretary.
(c) Reapplication. (1) An
Accreditation Body that has had its
approval withdrawn may submit a new
application for approval if the Body can
provide information to the Secretary to
establish that the problems that were
grounds for withdrawal of approval
have been resolved.
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(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 § 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
§ 8.11 Opioid Treatment Program
certification.
(a) General. (1) An OTP must be the
subject of a current, valid certification
from the Secretary to be considered
qualified by the Secretary under section
303(g)(1) of the Controlled Substances
Act (21 U.S.C. 823(h)(1)) to dispense
MOUD in the treatment of OUD. An
OTP must be determined to be qualified
under section 303(g)(1) of the Controlled
Substances Act, and must be
determined to be qualified by the
Attorney General under section
303(g)(1), to be registered by the
Attorney General to dispense MOUD to
individuals for treatment of OUD.
(2) To obtain certification from the
Secretary, an OTP must meet the
Federal Opioid Use Disorder treatment
standards in § 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
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7555
that certification may be renewed
during the final certification year if the
OTP applies for certification renewal in
accordance with the steps outlined in
paragraph (a)(4) of this section.
(4) OTPs which satisfy the criteria for
certification under this section may
apply for renewal of their certification.
OTPs are expected to apply for
certification renewal during the final
year of the OTP’s certification period.
OTPs should take steps to ensure that
administrative tasks associated with
renewal are completed before the OTP’s
certification expires. OTPs may apply
for certification renewal in accordance
with the procedures as outlined in
paragraph (b) of this section. If an OTP
anticipates any delays in routine
certification renewal, an extension may
be requested by submitting to the
Secretary a statement justifying the
extension in accordance with paragraph
(e) of this section.
(5) OTPs that are certified and are
seeking certification renewal, and who
have been granted accreditation for one
year by an Accreditation Body as
provided under § 8.4(b)(1)(iii), may
receive a conditional certification for
one year unless the Secretary
determines that such conditional
certification would adversely affect
patient health. An OTP must obtain a
standard 3-year certification, as
described in paragraph (a)(3) of this
section, within the 1-year conditional
certification period. If standard
accreditation is not obtained by the OTP
within the 1-year conditional
certification period, the OTP’s
conditional certification will lapse, and
the Attorney General will be notified
that the OTP’s registration should be
revoked.
(6) OTPs whose certification has
expired, and who seek re-certification,
will be considered ‘‘new’’ programs and
will be required to apply for provisional
certification in accordance with
paragraph (d) of this section.
(b) Application for initial or renewal
certifications and re-certification.
Applications for certification must be
submitted by the OTP using form SMA–
162. The application for initial or
renewal of certification shall include, as
determined by the Secretary:
(1) A description of the current
accreditation status of the OTP;
(2) A description of the organizational
structure of the OTP;
(3) The names of the persons
responsible for the OTP;
(4) The addresses of the OTP and of
each medication unit or other facility
under the of the OTP;
(5) The sources of funding for the OTP
and the name and address of each
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governmental entity that provides such
funding;
(6) A statement that the OTP will
comply with the conditions of
certification set forth in paragraph (g) of
this section; and
(7) The application shall be signed by
the program sponsor who shall certify
that the information submitted in the
application is truthful and accurate.
(8) Applications for re-certification
shall include an explanation of why the
OTP’s most recent certification expired
and information regarding the schedule
for an accreditation survey.
(c) Action on application. (1)
Following the Secretary’s receipt of an
application for certification of an OTP,
and after consultation with the
appropriate State authority regarding
the qualifications of the applicant, the
Secretary may grant the application for
certification, or renew an existing
certification, if the Secretary determines
that the OTP has satisfied the
requirements for certification or renewal
of certification in this section.
(2) The Secretary may deny the
application if the Secretary determines
that:
(i) The application for certification is
deficient in any respect;
(ii) The OTP will not be operated in
accordance with the Federal Opioid Use
Disorder treatment standards
established under § 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
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has applied for accreditation, the date
on which the OTP applied for
accreditation, the dates of any
accreditation surveys that have taken
place or are expected to take place, and
the expected schedule for completing
the accreditation process. Provisional
certification for up to 1 year will be
granted, following receipt of the
information described in this paragraph
(d), unless the Secretary determines that
patient health would be adversely
affected by the granting of provisional
certification.
(e) Requirements for certification. (1)
OTPs shall comply with all pertinent
Federal and State laws and regulations.
Nothing in this part is intended to limit
the authority of State and, as
appropriate, local governmental entities
to regulate the use of MOUD in the
treatment of OUD. The provisions of
this section requiring compliance with
requirements imposed by State law, or
the submission of applications or
reports required by the State authority,
do not apply to OTPs operated directly
by the Department of Veterans Affairs,
the Indian Health Service, or any other
department or agency of the United
States.
(2) OTPs shall allow, in accordance
with Federal controlled substances laws
and Federal confidentiality laws,
inspections and surveys by duly
authorized employees of the Department
of Health and Human Services (HHS) or
Substance Abuse and Mental Health
Services Administration (SAMHSA), by
Accreditation Bodies, by the Drug
Enforcement Administration (DEA), and
by authorized employees of any other
Federal governmental entity with legal
authority to conduct inspections or
surveys on an OTP’s premises.
(3) Disclosure of patient records
maintained by an OTP is governed by
the provisions of 42 CFR part 2 and 45
CFR parts 160 and 164, and every
program must comply with these
regulations, as applicable. Records on
the receipt, storage, and distribution of
MOUD are also subject to inspection
under Federal controlled substances
laws and under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321 et
seq.). Federally sponsored treatment
programs are subject to applicable
Federal confidentiality statutes.
(4) An OTP or medication unit or any
part thereof, including any facility or
any individual, shall permit a duly
authorized employee of the Department
of Health and Human Services or
SAMHSA to have access to and to copy
all records on the use of MOUD in
accordance with the provisions of 42
CFR part 2 and 45 CFR parts 160 and
164.
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(5) OTPs shall notify the Secretary in
writing within 3 weeks of any
replacement or other change in the
status of the program sponsor or
medical director.
(6) OTPs shall comply with all
regulations enforced by the DEA under
21 CFR chapter II and must be registered
by the DEA before administering or
dispensing MOUD.
(7) OTPs must operate in accordance
with Federal Opioid Use Disorder
treatment standards and approved
accreditation elements.
(f) Conditions for interim treatment
program approval. (1) Before an OTP
may provide interim treatment, the OTP
must receive the approval of both the
Secretary and the SOTA of the State in
which the OTP operates.
(2) Before the Secretary may grant
such approval, the OTP must provide
the Secretary with documentation from
the SOTA of the State in which the OTP
operates demonstrating that:
(i) Such officer does not object to the
providing of interim treatment in the
State;
(ii) The OTP seeking to provide such
treatment is unable to provide access for
patients in a comprehensive treatment
program within a reasonable geographic
area within 14 days of the time patients
seek treatment for OUD;
(iii) The authorization of the OTP to
provide interim treatment will not
otherwise reduce the capacity of
comprehensive treatment programs in
the State to admit individuals (relative
to the date on which such officer so
certifies); and
(iv) OTPs providing interim treatment
will arrange for each individual’s
transfer to a comprehensive treatment
program no later than 180 days from the
date on which each individual first
requested treatment. Individuals
enrolled in interim treatment shall not
be discharged without the approval of
an OTP practitioner, who shall consider
on-going and patient-centered treatment
needs, which are to be documented in
the patient record, while awaiting
transfer to a comprehensive treatment
program.
(3) The Secretary will provide notice
to the OTP denying or approving the
request to provide interim treatment.
The OTP shall not provide such
treatment until it has received such
notice from the Secretary.
(g) Exemptions. An OTP may, at the
time of application for certification or
any time thereafter, request from the
Secretary exemption from the regulatory
requirements set forth under this section
and § 8.12. An example of a case in
which an exemption might be granted
would be for a private practitioner who
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wishes to treat a limited number of
patients in a non-metropolitan area with
few physicians and no OUD treatment
services geographically accessible, and
requests exemption from some of the
staffing and service standards. The OTP
shall support the rationale for the
exemption with thorough
documentation, to be supplied in an
appendix to the initial application for
certification or in a separate submission.
The Secretary will approve or deny such
exemptions at the time of application, or
any time thereafter, if appropriate. The
Secretary shall consult with the
appropriate State authority prior to
taking action on an exemption request.
(h) Medication units, long-term care
facilities and hospitals. (1) Certified
OTPs may establish medication units
that are authorized to dispense MOUD.
Before establishing a medication unit, a
certified OTP must notify the Secretary
by submitting form SMA–162. The OTP
must also comply with the provisions of
21 CFR part 1300 before establishing a
medication unit. Medication units shall
comply with all pertinent State laws
and regulations. Medication units
include both mobile and brick and
mortar facilities.
(2) Specifically, any services that are
provided in an OTP may be provided in
the medication unit, assuming
compliance with all applicable Federal,
State, and local law, and the use of units
that provide appropriate privacy and
have adequate space.
(3) Certification as an OTP under this
part is not required for the initiation or
continuity of medication treatment or
withdrawal management of a patient
who is admitted to a hospital, long-term
care facility, or correctional facility, that
is registered with the Drug Enforcement
Administration as a hospital/clinic, for
the treatment of medical conditions
other than OUD, and who requires
treatment of OUD with methadone
during their stay, when such treatment
is permitted under applicable Federal
law.
(i) The term ‘‘long-term care facility’’
is defined in § 8.2. Nothing in this
section is intended to relieve hospitals,
or long-term care facilities and
correctional facilities that are registered
with the Drug Enforcement
Administration as a hospital/clinic,
from their obligations to obtain
appropriate registration from the
Attorney General, under section 303(g)
of the Controlled Substances Act.
Treatment provided under this section
should always comply with applicable
Federal laws.
(ii) [Reserved]
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§ 8.12 Federal Opioid Use Disorder
treatment standards.
(a) General. OTPs must provide
treatment in accordance with the
standards in this section and must
comply with these standards as a
condition of certification.
(b) Administrative and organizational
structure. (1) An OTP’s organizational
structure and facilities shall be adequate
to ensure quality patient care and to
meet the requirements of all pertinent
Federal, State, and local laws and
regulations. At a minimum, each OTP
shall formally designate a program
sponsor and medical director. The
program sponsor shall agree on behalf of
the OTP to adhere to all requirements
set forth in this part.
(2) The medical director shall assume
responsibility for all medical and
behavioral health services performed by
the OTP. In addition, the medical
director shall be responsible for
ensuring that the OTP is in compliance
with all applicable Federal, State, and
local laws and regulations.
(c) Continuous quality improvement.
(1) An OTP must maintain current
quality assurance and quality control
plans that include, among other things,
annual reviews of program policies and
procedures and ongoing assessment of
patient outcomes.
(2) An OTP must maintain a current
‘‘Diversion Control Plan’’ or ‘‘DCP’’ as
part of its quality assurance program
that contains specific measures to
reduce the possibility of diversion of
dispensed MOUD, and that assigns
specific responsibility to the OTP
providers and administrative staff for
carrying out the diversion control
measures and functions described in the
DCP.
(d) Staff credentials. Each person
engaged in the treatment of OUD must
have sufficient education, training, and
experience, or any combination thereof,
to enable that person to perform the
assigned functions. All practitioners and
other licensed/certified health care
providers, including counselors, must
comply with the credentialing and
maintenance of licensure and/or
certification requirements of their
respective professions.
(e) Patient admission criteria—(1)
Comprehensive treatment. An OTP shall
maintain current procedures designed to
ensure that patients are admitted to
treatment by qualified personnel who
have determined, using accepted
medical criteria, that: The person meets
diagnostic criteria for a moderate to
severe OUD; the individual has an
active moderate to severe OUD, or OUD
in remission, or is at high risk for
recurrence or overdose. Such decisions
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7557
must be appropriately documented in
the patient’s clinical record. In addition,
a health care practitioner shall ensure
that each patient voluntarily chooses
treatment with MOUD and that all
relevant facts concerning the use of
MOUD are clearly and adequately
explained to the patient, and that each
patient provides informed consent to
treatment.
(2) Comprehensive treatment for
persons under age 18. Except in States
where State law grants persons under 18
years of age the ability to consent to
OTP treatment without the consent of
another, no person under 18 years of age
may be admitted to OTP treatment
unless a parent, legal guardian, or
responsible adult designated by the
relevant State authority consents in
writing to such treatment.
(3) Withdrawal management. An OTP
shall maintain current procedures that
are designed to ensure that those
patients who choose to taper from
MOUD are provided the opportunity to
do so with informed consent and at a
mutually agreed-upon rate that
minimizes taper-related risks. Such
consent must be documented in the
clinical record by the treating
practitioner.
(f) Required services—(1) General.
OTPs shall provide adequate medical,
counseling, vocational, educational, and
other screening, assessment, and
treatment services to meet patient
needs, with the combination and
frequency of services tailored to each
individual patient based on an
individualized assessment and the
patient’s care plan that was created after
shared decision making between the
patient and the clinical team. These
services must be available at the
primary facility, except where the
program sponsor has entered into a
documented agreement with a private or
public agency, organization,
practitioner, or institution to provide
these services to patients enrolled in the
OTP. The program sponsor, in any
event, must be able to document that
these services are fully and reasonably
available to patients.
(2) Initial medical examination. (i)
OTPs shall require each patient to
undergo an initial medical examination.
The initial medical examination is
comprised of two parts:
(A) A screening examination to ensure
that the patient meets criteria for
admission and that there are no
contraindications to treatment with
MOUD; and
(B) A full history and examination, to
determine the patient’s broader health
status, with lab testing as determined to
be required by an appropriately licensed
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practitioner. A patient’s refusal to
undergo lab testing for co-occurring
physical health conditions should not
preclude them from access to treatment,
provided such refusal does not have
potential to negatively impact treatment
with medications.
(ii) Assuming no contraindications, a
patient may commence treatment with
MOUD after the screening examination
has been completed. Both the screening
examination and full examination must
be completed by an appropriately
licensed practitioner. If the licensed
practitioner is not an OTP practitioner,
the screening examination must be
completed no more than seven days
prior to OTP admission. Where the
examination is performed outside of the
OTP, the written results and narrative of
the examination, as well as available lab
testing results, must be transmitted,
consistent with applicable privacy laws,
to the OTP, and verified by an OTP
practitioner.
(iii) A full in-person physical
examination, including the results of
serology and other tests that are
considered to be clinically appropriate,
must be completed within 14 calendar
days following a patient’s admission to
the OTP. The full exam can be
completed by a non-OTP practitioner, if
the exam is verified by a licensed OTP
practitioner as being true and accurate
and transmitted in accordance with
applicable privacy laws.
(iv) Serology testing and other testing
as deemed medically appropriate by the
licensed OTP practitioner based on the
screening or full history and
examination, drawn not more than 30
days prior to admission to the OTP, may
form part of the full history and
examination.
(v) The screening and full
examination may be completed via
telehealth for those patients being
admitted for treatment at the OTP with
either buprenorphine or methadone, if a
practitioner or primary care provider,
determines that an adequate evaluation
of the patient can be accomplished via
telehealth. When using telehealth, the
following caveats apply:
(A) In evaluating patients for
treatment with schedule II medications
(such as Methadone), audio-visual
telehealth platforms must be used,
except when not available to the patient.
When not available, it is acceptable to
use audio-only devices, but only when
the patient is in the presence of a
licensed practitioner who is registered
to prescribe (including dispense)
controlled medications. The OTP
practitioner shall review the
examination results and order treatment
medications as indicated.
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(B) In evaluating patients for
treatment with schedule III medications
(such as Buprenorphine) or medications
not classified as a controlled medication
(such as Naltrexone), audio-visual or
audio only platforms may be used. The
OTP practitioner shall review the
examination results and order treatment
medications as indicated.
(3) Special services for pregnant
patients. OTPs must maintain current
policies and procedures that reflect the
special needs and priority for treatment
admission of patients with OUD who
are pregnant. Pregnancy should be
confirmed. Evidence-based treatment
protocols for the pregnant patient, such
as split dosing regimens, may be
instituted after assessment by an OTP
practitioner and documentation that
confirms the clinical appropriateness of
such an evidence-based treatment
protocol. Prenatal care and other sexspecific 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
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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 recoveryoriented counseling. This counseling
shall be provided by a program
counselor, qualified by education,
training, or experience to assess the
psychological and sociological
background of patients, and engage with
patients, to contribute to the appropriate
care plan for the patient and to monitor
and update patient progress. Patient
refusal of counseling shall not preclude
them from receiving MOUD.
(ii) OTPs must provide counseling on
preventing exposure to, and the
transmission of, human
immunodeficiency virus (HIV), viral
hepatitis, and sexually transmitted
infections (STIs) and either directly
provide services and treatments or
actively link to treatment each patient
admitted or readmitted to treatment
who has received positive test results
for these conditions from initial and/or
periodic medical examinations.
(iii) OTPs must provide directly, or
through referral to adequate and
reasonably accessible community
resources, vocational training,
education, and employment services for
patients who request such services or
for whom these needs have been
identified and mutually agreed-upon as
beneficial by the patient and program
staff.
(6) Drug testing services. When
conducting random drug testing, OTPs
must use drug tests that have received
the Food and Drug Administration’s
(FDA) marketing authorization for
commonly used and misused substances
that may impact patient safety, recovery,
or otherwise complicate substance use
disorder treatment, at a frequency that is
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in accordance with generally accepted
clinical practice and as indicated by a
patient’s response to and stability in
treatment, but no fewer than eight
random drug tests per year patient,
allowing for extenuating circumstances
at the individual patient level. This
requirement does not preclude
distribution of legal harm reduction
supplies that allow an individual to test
their personal drug supply for
adulteration with substances that
increase the risk of overdose.
(g) Recordkeeping and patient
confidentiality. (1) OTPs shall establish
and maintain a recordkeeping system
that is adequate to document and
monitor patient care. This system is
required to comply with all Federal and
State reporting requirements relevant to
MOUD approved for use in treatment of
OUD. All records are required to be kept
confidential in accordance with all
applicable Federal and State
requirements.
(2) OTPs shall include, as an essential
part of the recordkeeping system,
documentation in each patient’s record
that the OTP made a good faith effort to
determine whether the patient is
enrolled in any other OTP. A patient
enrolled in an OTP shall not be
permitted to obtain treatment in any
other OTP except in circumstances
involving an inability to access care at
the patient’s OTP of record. Such
circumstances include, but are not
limited to, travel for work or family
events, temporary relocation, or an
OTP’s temporary closure. If the medical
director or program practitioner of the
OTP in which the patient is enrolled
determines that such circumstances
exist, the patient may seek treatment at
another OTP, provided the justification
for the particular circumstances are
noted in the patient’s record both at the
OTP in which the patient is enrolled
and at the OTP that will provide the
MOUD.
(h) Medication administration,
dispensing, and use. (1) OTPs must
ensure that MOUD are administered or
dispensed only by a practitioner
licensed under the appropriate State law
and registered under the appropriate
State and Federal laws to administer or
dispense MOUD, or by an agent of such
a practitioner, supervised by and under
the order of the licensed practitioner
and if consistent with Federal and State
law.
(2) OTPs shall use only those MOUD
that are approved by the Food and Drug
Administration under section 505 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) for use in the treatment
of OUD. In addition, OTPs who are fully
compliant with the protocol of an
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investigational use of a drug and other
conditions set forth in the application
may administer a drug that has been
authorized by the Food and Drug
Administration under an investigational
new drug application under section
505(i) of the Federal Food, Drug, and
Cosmetic Act for investigational use in
the treatment of OUD. Currently the
following MOUD will be considered to
be approved by the Food and Drug
Administration for use in the treatment
of OUD:
(i) Methadone;
(ii) Buprenorphine and
buprenorphine combination products
that have been approved for use in the
treatment of OUD; and
(iii) Naltrexone.
(3) OTPs shall maintain current
procedures that are adequate to ensure
that the following dosage form and
initial dosing requirements are met:
(i) Methadone shall be administered
or dispensed only in oral form and shall
be formulated in such a way as to
reduce its potential for parenteral
misuse.
(ii) For each new patient enrolled in
an OTP, the initial dose of methadone
shall be individually determined and
shall include consideration of the
type(s) of opioid(s) involved in the
patient’s opioid use disorder, other
medications or substances being taken,
medical history, and severity of opioid
withdrawal. The total dose for the first
day should not exceed 50 milligrams
unless the OTP practitioner, licensed
under the appropriate State law and
registered under the appropriate State
and Federal laws to administer or
dispense MOUD, finds sufficient
medical rationale, including but not
limited to if the patient is transferring
from another OTP on a higher dose that
has been verified, and documents in the
patient’s record that a higher dose was
clinically indicated.
(4) OTPs shall maintain current
procedures adequate to ensure that each
MOUD used by the program is
administered and dispensed in
accordance with its FDA approved
product labeling. The program must
ensure that any significant deviations
from the approved labeling, including
deviations with regard to dose,
frequency, or the conditions of use
described in the approved labeling, are
specifically documented in the patient’s
record.
(i) Unsupervised or ‘‘take-home’’
medication doses. Unsupervised or
‘‘take-home’’ medication doses may be
provided under the following
circumstances:
(1) Any patient in comprehensive
treatment may receive their
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individualized take-home doses as
ordered for days that the clinic is closed
for business, including one weekend
day (e.g., Sunday) and State and Federal
holidays, no matter their length of time
in treatment.
(2) OTP decisions on dispensing
MOUD to patients for unsupervised use
beyond that set forth in paragraph (i)(1)
of this section shall be determined by an
appropriately licensed OTP medical
practitioner or the medical director. In
determining which patients may receive
unsupervised medication doses, the
medical director or program medical
practitioner shall consider, among other
pertinent factors that indicate that the
therapeutic benefits of unsupervised
doses outweigh the risks, the following
criteria:
(i) Absence of active substance use
disorders, other physical or behavioral
health conditions that increase the risk
of patient harm as it relates to the
potential for overdose, or the ability to
function safely;
(ii) Regularity of attendance for
supervised medication administration;
(iii) Absence of serious behavioral
problems that endanger the patient, the
public or others;
(iv) Absence of known recent
diversion activity;
(v) Whether take-home medication
can be safely transported and stored;
and
(vi) Any other criteria that the
medical director or medical practitioner
considers relevant to the patient’s safety
and the public’s health.
(3) Such determinations and the basis
for such determinations consistent with
the criteria outlined in paragraph (i)(2)
of this section shall be documented in
the patient’s medical record. If it is
determined that a patient is safely able
to manage unsupervised doses of
MOUD, the dispensing restrictions set
forth in paragraphs (i)(3)(i) through (iii)
of this section apply. The dispensing
restrictions set forth in paragraphs
(i)(3)(i) through (iii) of this section do
not apply to buprenorphine and
buprenorphine products listed under
paragraph (h)(2)(ii) of this section.
(i) During the first 14 days of
treatment, the take-home supply
(beyond that of paragraph (i)(1) of this
section) is limited to 7 days. It remains
within the OTP practitioner’s discretion
to determine the number of take-home
doses up to 7 days, but decisions must
be based on the criteria listed in
paragraph (i)(2) of this section. The
rationale underlying the decision to
provide unsupervised doses of
methadone must be documented in the
patient’s clinical record, consistent with
paragraph (g)(2) of this section.
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(ii) From 15 days of treatment, the
take-home supply (beyond that of
paragraph (i)(1) of this section) is
limited to 14 days. It remains within the
OTP practitioner’s discretion to
determine the number of take-home
doses up to 14 days, but this
determination must be based on the
criteria listed in paragraph (i)(2) of this
section. The rationale underlying the
decision to provide unsupervised doses
of methadone must be documented in
the patient’s clinical record, consistent
with paragraph (g)(2) of this section.
(iii) From 31 days of treatment, the
take-home supply (beyond that of
paragraph (i)(1) of this section) provided
to a patient is not to exceed 28 days. It
remains within the OTP practitioner’s
discretion to determine the number of
take-home doses up to 28 days, but this
determination must be based on the
criteria listed in paragraph (i)(2) of this
section. The rationale underlying the
decision to provide unsupervised doses
of methadone must be documented in
the patient’s clinical record, consistent
with paragraph (g)(2) of this section.
(4) OTPs must maintain current
procedures adequate to identify the theft
or diversion of take-home medications,
including labeling containers with the
OTP’s name, address, and telephone
number. Programs also must ensure that
each individual take-home dose is
packaged in a manner that is designed
to reduce the risk of accidental
ingestion, including child-proof
containers (see Poison Prevention
Packaging Act, Pub. L. 91–601 (15
U.S.C. 1471 et seq.)). Programs must
provide education to each patient on:
Safely transporting medication from the
OTP to their place of residence; and the
safe storage of take-home doses at the
individual’s place of residence,
including child and household safety
precautions. The provision of this
education should be documented in the
patient’s clinical record.
(j) Interim treatment. (1) The program
sponsor of an OTP may admit an
individual, who is eligible for admission
to comprehensive treatment, into
interim treatment if comprehensive
services are not readily available within
a reasonable geographic area and within
14 days of the individual’s seeking
treatment. At least two drug tests shall
be obtained from patients during the
maximum of 180 days permitted for
interim treatment. A program shall
establish and follow reasonable criteria
for establishing priorities for moving
patients from interim to comprehensive
treatment. These transition criteria shall
be in writing and shall include, at a
minimum, prioritization of pregnant
patients in admitting patients to interim
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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 § 8.11(h).
(4) All requirements for
comprehensive treatment apply to
interim treatment with the following
exceptions:
(i) A primary counselor is not
required to be assigned to the patient,
but crisis services, including shelter
support, should be available;
(ii) Interim treatment cannot be
provided for longer than 180 days in
any 12-month period;
(iii) By day 120, a plan for continuing
treatment beyond 180 days must be
created, and documented in the
patient’s clinical record; and
(iv) Formal counseling, vocational
training, employment, economic, legal,
educational, and other recovery support
services described in paragraphs (f)(4)
and (f)(5)(i) and (iii) of this section are
not required to be offered to the patient.
However, information pertaining to
locally available, community-based
resources for ancillary services should
be made available to individual patients
in interim treatment.
§ 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 § 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
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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 § 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.
§ 8.14 Suspension or revocation of
certification.
(a) Revocation. Except as provided in
paragraph (b) of this section, the
Secretary may revoke the certification of
an OTP if the Secretary finds, after
providing the program sponsor with
notice and an opportunity for a hearing
in accordance with this subpart, that the
program sponsor, or any employee of
the OTP:
(1) Has been found to have engaged in
misrepresentation in obtaining the
certification;
(2) Has failed to comply with the
Federal Opioid Use Disorder treatment
standards in any respect;
(3) Has failed to comply with
reasonable requests from the Secretary
or from an Accreditation Body for
records, information, reports, or
materials that are necessary to
determine the continued eligibility of
the OTP for certification or continued
compliance with the Federal Opioid Use
Disorder treatment standards; or
(4) Has refused a reasonable request of
a duly designated inspector, Drug
Enforcement Administration (DEA)
Inspector, State Inspector, or
Accreditation Body representative for
permission to inspect the program or the
program’s operations or its records.
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(b) Suspension. Whenever the
Secretary has reason to believe that
revocation may be required and that
immediate action is necessary to protect
public health or safety, the Secretary
may immediately suspend the
certification of an OTP, and notify the
Attorney General that the OTP’s
registration should be suspended, before
holding a hearing under this subpart.
The Secretary may immediately
suspend as well as propose revocation
of the certification of an OTP before
holding a hearing under this subpart if
the Secretary makes a finding described
in paragraph (a) of this section and also
determines that:
(1) The failure to comply with the
Federal Opioid Use Disorder treatment
standards presents an imminent danger
to the public health or safety;
(2) The refusal to permit inspection
makes immediate suspension necessary;
or
(3) There is reason to believe that the
failure to comply with the Federal
Opioid Use Disorder treatment
standards was intentional or was
associated with fraud.
(c) Written notification. In the event
that the Secretary suspends the
certification of an OTP in accordance
with paragraph (b) of this section or
proposes to revoke the certification of
an OTP in accordance with paragraph
(a) of this section, the Secretary shall
promptly provide the sponsor of the
OTP with written notice of the
suspension or proposed revocation by
facsimile transmission, personal service,
commercial overnight delivery service,
or certified mail, return receipt
requested. Such notice shall state the
reasons for the action, state that the OTP
may seek review of the action in
accordance with the procedures in this
subpart, and identify the reviewing
official to whom a written request for
review may be submitted.
(d) Procedure. (1) If the Secretary
suspends certification in accordance
with paragraph (b) of this section:
(i) The Secretary will immediately
notify DEA that the OTP’s registration
should be suspended under 21 U.S.C.
824(d); and
(ii) the Secretary will provide an
opportunity for a hearing under this
subpart.
(2) Suspension of certification under
paragraph (b) of this section shall
remain in effect until the agency
determines that:
(i) The basis for the suspension
cannot be substantiated;
(ii) Violations of required standards
have been corrected to the agency’s
satisfaction; or
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(iii) The OTP’s certification shall be
revoked.
§ 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
§ 8.3.
Subpart D—Procedures for Informal
Review of Suspension or Proposed
Revocation of OTP Certification, and of
Adverse Action Regarding Withdrawal
of Approval of an Accreditation Body
§ 8.21
Applicability.
The procedures in this subpart apply
when:
(a) The Secretary has notified an OTP
in writing that its certification under the
regulations in subpart B of this part has
been suspended or that the Secretary
proposes to revoke the certification; and
(b) The OTP has, within 30 days of
the date of the notification or within 3
days of the date of the notification when
seeking an expedited review of a
suspension, requested in writing to the
reviewing official, an opportunity for an
informal review of the suspension or
proposed revocation.
(c) The Secretary has notified an
Accreditation Body of an adverse action
taken regarding withdrawal of approval
of the Accreditation Body under the
regulations in subpart A of this part; and
(d) The Accreditation Body has,
within 30 days of the date of the
notification, requested in writing an
opportunity for a review of the adverse
action.
§ 8.22
Definitions.
The following definitions apply to
this subpart:
Appellant means:
(1) The OTP which has been notified
of its suspension or proposed revocation
of its certification under the regulations
of this part and has requested a review
of the suspension or proposed
revocation; or
(2) The Accreditation Body which has
been notified of adverse action
regarding withdrawal of approval under
the regulations of this subpart and has
requested a review of the adverse action.
Respondent means SAMHSA.
Reviewing official means the person
or persons designated by the Secretary
who will informally review the
suspension or proposed revocation. The
reviewing official may be assisted by
one or more Department of Health and
Human Services (HHS) officers or
employees or consultants in assessing
and weighing the scientific and
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7561
technical evidence and other
information submitted by the appellant
and respondent on the reasons for the
suspension and proposed revocation.
§ 8.23 Limitation on issues subject to
review.
The scope of this informal review
shall be limited to the facts relevant to
any suspension, or proposed revocation,
or adverse action, the necessary
interpretations of the facts, the
regulations in this subpart, and other
relevant law.
§ 8.24 Specifying who represents the
parties.
The appellant’s request for an
informal review shall specify the name,
address, and phone number of the
appellant’s representative. In its first
written submission to the reviewing
official, the respondent shall specify the
name, address, and phone number of
the respondent’s representative.
§ 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.
§ 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
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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.
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§ 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
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initiative or at the request of the
respondent.
(b) Presiding official. The reviewing
official or designee will be the presiding
official responsible for managing the
oral presentations.
(c) Preliminary conference. The
presiding official may hold a prehearing
conference (usually a telephone
conference call) to consider any of the
following: Simplifying and clarifying
issues; stipulations and admissions;
limitations on evidence and witnesses
that will be presented at the hearing;
time allotted for each witness and the
hearing altogether; scheduling the
hearing; and any other matter that will
assist in the review process. Normally,
this conference will be conducted
informally and off the record; however,
the presiding official may, at the
presiding official’s discretion, produce a
written document summarizing the
conference or transcribe the conference.
(d) Time and place of oral
presentation. The presiding official will
attempt to schedule the oral
presentation within 45 days of the date
appellant’s request for review is
received or within 15 days of
submission of the last reply brief,
whichever is later. The oral presentation
will be held at a time and place
determined by the presiding official
following consultation with the parties.
(e) Conduct of the oral presentation—
(1) General. The presiding official is
responsible for conducting the oral
presentation. The presiding official may
be assisted by one or more HHS officers
or employees or consultants in
conducting the oral presentation and
reviewing the evidence. While the oral
presentation will be kept as informal as
possible, the presiding official may take
all necessary steps to ensure an orderly
proceeding.
(2) Burden of proof/standard of proof.
In all cases, the respondent bears the
burden of proving by a preponderance
of the evidence that its decision to
suspend, propose revocation, or take
adverse action is appropriate. The
appellant, however, has a responsibility
to respond to the respondent’s
allegations with evidence and argument
to show that the respondent is incorrect.
(3) Admission of evidence. The rules
of evidence do not apply, and the
presiding official will generally admit
all testimonial evidence unless it is
clearly irrelevant, immaterial, or unduly
repetitious. Each party may make an
opening and closing statement, may
present witnesses as agreed upon in the
pre-hearing conference or otherwise,
and may question the opposing party’s
witnesses. Since the parties have ample
opportunity to prepare the review file,
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a party may introduce additional
documentation during the oral
presentation only with the permission
of the presiding official. The presiding
official may question witnesses directly
and take such other steps necessary to
ensure an effective and efficient
consideration of the evidence, including
setting time limitations on direct and
cross-examinations.
(4) Motions. The presiding official
may rule on motions including, for
example, motions to exclude or strike
redundant or immaterial evidence,
motions to dismiss the case for
insufficient evidence, or motions for
summary judgment. Except for those
made during the hearing, all motions
and opposition to motions, including
argument, must be in writing and be no
more than 10 double-spaced pages in
length. The presiding official will set a
reasonable time for the party opposing
the motion to reply.
(5) Transcripts. The presiding official
shall have the oral presentation
transcribed. Either party may request a
copy of the transcript and the requesting
party shall be responsible for paying for
its copy of the transcript.
(f) Obstruction of justice or making of
false statements. Obstruction of justice
or the making of false statements by a
witness or any other person may be the
basis for a criminal prosecution under
18 U.S.C. 1001 or 1505.
(g) Post-hearing procedures. At the
presiding official’s discretion, the
presiding official may require or permit
the parties to submit post-hearing briefs
or proposed findings and conclusions.
Each party may submit comments on
any major prejudicial errors in the
transcript.
§ 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
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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
§ 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 § 8.27(c) and will
conduct the oral presentation in
accordance with the procedures of
§ 8.27(e), (f), and (g).
(e) Written decision. The reviewing
official shall issue a written decision
upholding or denying the suspension or
proposed revocation and will attempt to
issue the decision within 7 to 10 days
of the date of the oral presentation or
within 3 days of the date on which the
transcript is received or the date of the
last submission by either party,
whichever is later. All other provisions
set forth in § 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.
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§ 8.29
Ex parte communications.
For the purposes of maintaining the
equity of informal review proceedings,
except for routine administrative and
procedural matters or as described in
§§ 8.22(2) and 8.27(e), a party shall not
communicate with the reviewing or
presiding official without notice to the
other party.
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§ 8.30 Transmission of written
communications by reviewing official and
calculation of deadlines.
(a) Timely review. Because of the
importance of a timely review, the
reviewing official should normally
transmit written communications to
either party by facsimile transmission,
personal service, or commercial
overnight delivery service, or certified
mail, return receipt requested, in which
case the date of transmission or day
following mailing will be considered the
date of receipt. In the case of
communications sent by regular mail,
the date of receipt will be considered 3
days after the date of mailing.
(b) Due date. In counting days,
include Saturdays, Sundays, and
holidays. However, if a due date falls on
a Saturday, Sunday, or Federal holiday,
then the due date is the next Federal
working day.
§ 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.
§ 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.
§ 8.33
Written decision.
(a) Issuance of decision. The
reviewing official shall issue a written
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decision upholding or denying the
suspension, proposed revocation, or
adverse action. The decision will set
forth the reasons for the decision and
describe the basis for that decision in
the record. Furthermore, the reviewing
official may remand the matter to the
respondent for such further action as the
reviewing official deems appropriate.
(b) Date of decision. The reviewing
official will attempt to issue the
decision within 15 days of the date of
the oral presentation, the date on which
the transcript is received, or the date of
the last submission by either party,
whichever is later. If there is no oral
presentation, the decision will normally
be issued within 15 days of the date of
receipt of the last reply brief. Once
issued, the reviewing official will
immediately communicate the decision
to each party.
(c) Public notice and communications
to the Drug Enforcement Administration
(DEA). (1) If the suspension and
proposed revocation of OTP
certification are upheld, the revocation
of certification will become effective
immediately and the public will be
notified by publication of a notice in the
Federal Register. The Secretary will
notify DEA within 5 days that the OTP’s
registration should be revoked.
(2) If the suspension and proposed
revocation of OTP certification are
denied, the revocation will not take
effect and the suspension will be lifted
immediately. Public notice will be given
by publication in the Federal Register.
The Secretary will notify DEA within 5
days that the OTP’s registration should
be restored, if applicable.
§ 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 § 8.28(e) or § 8.33(a), constitutes
final agency action as of the date of the
decision.
Subpart E [Reserved]
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2024–01693 Filed 1–31–24; 4:15 pm]
BILLING CODE 4162–20–P
E:\FR\FM\02FER4.SGM
02FER4
Agencies
[Federal Register Volume 89, Number 23 (Friday, February 2, 2024)]
[Rules and Regulations]
[Pages 7528-7563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01693]
[[Page 7527]]
Vol. 89
Friday,
No. 23
February 2, 2024
Part IV
Department of Health and Human Services
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42 CFR Part 8
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Medications for the Treatment of Opioid Use Disorder; Final Rule
Federal Register / Vol. 89 , No. 23 / Friday, February 2, 2024 /
Rules and Regulations
[[Page 7528]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
42 CFR Part 8
RIN 0930-AA39
Medications for the Treatment of Opioid Use Disorder
AGENCY: Substance Abuse and Mental Health Services Administration
(SAMHSA), Department of Health and Human Services (``HHS'' or ``the
Department'').
ACTION: Final rule.
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SUMMARY: This final rule modifies and updates certain provisions of
regulations related to Opioid Treatment Program (OTP) accreditation,
certification, and standards for the treatment of Opioid Use Disorder
(OUD) with Medications for Opioid Use Disorder (MOUD) in OTPs. This
includes making flexibilities put forth during the COVID-19 Public
Health Emergency (PHE) permanent, as well as expanding access to care
and evidence-based treatment for OUD. The final rule also removes all
language and rules pertaining to the Drug Addiction and Treatment Act
(DATA) Waiver from the regulations pursuant to the ``Consolidated
Appropriations Act, 2023''.
DATES: The effective date of this final rule is April 2, 2024, and the
compliance date is October 2, 2024.
FOR FURTHER INFORMATION CONTACT: Robert Baillieu, MD, MPH, Physician
and Senior Advisor, SAMHSA/CSAT, 5600 Fishers Lane, Room 13-E-30,
Rockville, MD, 20857, Phone: 202-923-0996, Email:
[email protected].
SUPPLEMENTARY INFORMATION: The discussion below includes an Executive
Summary and overview describing the rule, responses to public comments,
an impact statement, and other required regulatory analyses.
Executive Summary
A. Overview
This regulation finalizes the Department's proposed rule concerning
Medications for the Treatment of Opioid Use Disorder published in the
Federal Register on December 16, 2022 (87 FR 77330). It also finalizes
proposals found in the Department's supplemental notice of proposed
rulemaking concerning removal of the DATA-2000 Waiver requirements
issued in the Federal Register on February 13, 2023 (88 FR 9221). The
final rule makes changes to the Department's existing regulations
concerning OTPs at 42 CFR part 8.
The Controlled Substances Act (CSA), under 21 U.S.C. 823(h)(1)-(3),
provides that ``[t]he Attorney General shall register an applicant to
dispense narcotic drugs to individuals for maintenance treatment or
detoxification treatment (or both)'' if, among other things, the
applicant ``is determined by the Secretary to be qualified (under
standards established by the Secretary [of HHS]) to engage in the
treatment with respect to which registration is sought[,]'' and ``if
the Secretary determines that the applicant will comply with standards
established by the Secretary (after consultation with the Attorney
General) respecting the quantities of narcotic drugs which may be
provided for unsupervised use by individuals in such treatment.'' \1\
The Secretary's standards authorized under section 823(h) have been
published as regulations under part 8 of title 42 of the Code of
Federal Regulations (``42 CFR part 8'' or ``part 8'').\2\ Among other
things, these regulations establish the procedures by which the
Secretary of HHS determines whether a program is qualified to dispense
opioid agonist medications in the treatment of opioid use disorders,
and standards regarding the appropriate quantities of opioid agonist
medications that may be provided for unsupervised use by individuals
undergoing such treatment.\3\ In addition, ``a program or practitioner
engaged in opioid treatment of individuals with an opioid agonist
treatment medication'' that is also ``registered under 21 U.S.C.
823(h)(1)'' is described as an ``Opioid Treatment Program'' (OTP).\4\
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\1\ See 21 U.S.C. 823(h)(1)-(3).
\2\ For readability, the Department refers to specific sections
of 42 CFR part 8 using a shortened citation with the ``Sec. ''
symbol except where necessary to distinguish title 42 citations from
other CFR titles, such as title 45 CFR, and in footnotes where the
full reference is used.
\3\ See 42 CFR 8.1
\4\ The terms ``narcotic drugs'' and ``detoxification
treatment'' included in this paragraph are found in statute. SAMHSA
recognizes that these terms can be stigmatizing for some people, and
not aligned with current terminology. SAMHSA uses ``opioid agonist
medications'' (see Treatment Improvement Protocol (TIP) 63) as an
alternative to ``narcotic drugs'' and ``withdrawal management'' as
the alternative to ``detoxification treatment''.
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On December 29, 2022, the `Consolidated Appropriations Act, 2023'
(Pub. L. No: 117-328) was enacted, resulting in the removal of
requirements to obtain a waiver from the registration requirements of
21 U.S.C. 823(h)(1) for qualifying practitioners seeking to dispense or
prescribe schedule III, IV, or V controlled substances that are FDA-
approved for use in ``maintenance and detoxification treatment.''
Practitioners with a waiver under section 823(h)(2) were limited in the
number of patients with OUD they may treat at any one time, and
depending on the practitioner's experience or qualifications, this
statutory limitation was set at either 30, 100, or 275.\5\ The
Secretary was also authorized to change the patient limitations by
regulation, and qualifying practitioners had to satisfy the
requirements of 42 CFR 8.610 through 8.655 ``(or successor
regulations)'' in order to treat up to 275 patients, which was the
maximum number under the law.\6\
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\5\ Formally under 21 U.S.C. 823(h)(2)(B)(iii)
\6\ Formally under 21 U.S.C. 823(h)(2)(B)(iii)(II)(dd). See
https://www.govinfo.gov/content/pkg/USCODE-2016-title21/html/USCODE-2016-title21-chap13-subchapI-partC-sec823.htm.
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In this final rule, the Department modifies certain provisions of
part 8 to update OTP accreditation and certification standards, as well
as treatment standards for the provision of medications for opioid use
disorder (MOUD) as dispensed by OTPs. Pursuant to the `Consolidated
Appropriations Act, 2023' (Pub. L. No: 117-328), the final rule also
removes language pertaining to requirements for individual
practitioners to dispense (including by prescribing) certain types of
MOUD with a waiver under 21 U.S.C. 823(h)(2). SAMHSA has developed this
final rule in consultation with the Drug Enforcement Administration.
The final rule draws on experience from the COVID-19 Public Health
Emergency (PHE), as well as more than 20 years of practice-based
research. The COVID-19 PHE necessitated changes to policy guidance and
legal exemptions to protect the public's health, promote physical
distancing and to preserve patient and OTP staff safety. In March 2020,
SAMHSA published guidance regarding flexibilities that could be
leveraged in the provision of unsupervised doses of methadone and the
use of telehealth when initiating buprenorphine.\7\ These flexibilities
represented the first substantial change to OTP treatment and
medication delivery standards in more than 20 years, and their role in
facilitating access to treatment is supported by research.
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\7\ See https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf and https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
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This final rule not only makes these COVID-19-related flexibilities
permanent, but also updates standards
[[Page 7529]]
to reflect an accreditation and treatment environment that has evolved
since part 8 went into effect in 2001. Accordingly, the Department is
updating part 8 to promote practitioner autonomy; remove discriminatory
or outdated language; create a patient-centered perspective; and reduce
barriers to receiving care. These elements have been identified in the
literature and in feedback as being essential to promoting effective
treatment in OTPs.8 9 10
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\8\ Suen LW, Coe WH, Wyatt JP, Adams ZM, Gandhi M, Batchelor HM,
Castellanos S, Joshi N, Satterwhite S, P[eacute]rez-Rodr[iacute]guez
R, Rodr[iacute]guez-Guerra E, Albizu-Garcia CE, Knight KR, Jordan A.
Structural Adaptations to Methadone Maintenance Treatment and Take-
Home Dosing for Opioid Use Disorder in the Era of COVID-19. Am J
Public Health. 2022 Apr;112(S2):S112-S116. doi: 10.2105/
AJPH.2021.306654. PMID: 35349324; PMCID: PMC8965183.
\9\ Kleinman MB, Felton JW, Johnson A, Magidson JF. ``I have to
be around people that are doing what I'm doing'': The importance of
expanding the peer recovery coach role in treatment of opioid use
disorder in the face of COVID-19 health disparities. J Subst Abuse
Treat. 2021 Mar;122:108182. doi: 10.1016/j.jsat.2020.108182. Epub
2020 Oct 21. PMID: 33160763; PMCID: PMC7577312.
\10\ Suen LW, Castellanos S, Joshi N, Satterwhite S, Knight KR.
``The idea is to help people achieve greater success and liberty'':
A qualitative study of expanded methadone take-home access in opioid
use disorder treatment. Subst Abus. 2022;43(1):1143-1150. doi:
10.1080/08897077.2022.2060438. PMID: 35499469.
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To this end, the definition of a practitioner has been modified to
refer to a provider who is appropriately licensed by the State to
prescribe (including dispense) medications. Admission criteria have
been updated, as required by section 1252(b) of the `Consolidated
Appropriations Act, 2023', to remove significant barriers to entry,
such as the one-year requirement for opioid use disorder (OUD),\11\
while also defining the scope and purpose of the `initial' and
`periodic' medical examinations. The final rule also includes new
definitions to expand access to evidence-based practices such as split
dosing, telehealth and harm reduction activities. In addition, outdated
terms such as `detoxification' have been revised to remove stigmatizing
language.
---------------------------------------------------------------------------
\11\ See 42 CFR 8.12(e)(1).
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The Department promotes practitioner autonomy and individualized
care by finalizing the provision containing the criteria for
unsupervised doses of methadone. This includes removal from sole
consideration the length of time an individual has been in treatment
and requirements for rigid reliance on toxicology testing results that
demonstrate complete and sustained abstinence from all substances prone
to misuse. Based on the clinical judgment of the treating provider,
patients may be eligible for unsupervised, take-home doses of methadone
upon entry into treatment. This change recognizes the importance of the
practitioner-patient relationship and is consistent with modern
substance use disorder treatment standards.\12\ It also allows for
greater flexibility in creating plans of care that promote recovery
activities such as employment or education, while also eliminating the
barrier of frequent OTP visits for individuals without access to
reliable transportation.\13\
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\12\ Substance Abuse and Mental Health Services Administration.
Medications for Opioid Use Disorder. Treatment Improvement Protocol
(TIP) Series 63 Publication No. PEP21-02-01-002. Rockville, MD:
Substance Abuse and Mental Health Services Administration, 2021.
\13\ Ware OD, Frey JJ, Cloeren M, Mosby A, Imboden R, Bazell AT,
Huffman M, Hochheimer M, Greenblatt AD, Sherman SA. Examining
Employment and Employment Barriers Among a Sample of Patients in
Medication-Assisted Treatment in the United States, Addictive
Disorders & Their Treatment: December 2021--Volume 20--Issue 4--p
578-586 doi: 10.1097/ADT.0000000000000295.
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Accreditation and certification standards have been updated to
codify the use of online/electronic forms, and to reflect a modern
treatment environment. Part 8 has also been updated to facilitate
information sharing between Accreditation Bodies and SAMHSA,
particularly in those circumstances where there have been changes or
violations in accreditation. The final rule also clarifies
administrative issues pertaining to accreditation, mobile medication
units and interim treatment.
This final rule makes treatment in OTPs more accessible to
patients, while also supporting evidence-based and patient-centered
care. In creating these changes, SAMHSA has relied on published
evidence, stakeholder feedback, public comments to the proposed rule
and the need to expand access to care in the face of a growing overdose
epidemic, exacerbated by the COVID-19 pandemic.\14\ This is brought
further into focus by the HHS declaration of a public health emergency
for the opioid crisis which has been renewed regularly since 2017.\15\
While the COVID-19 public health emergency expired as of May 11,
2023,\16\ the lessons learned from the COVID-19 pandemic remain
relevant for ensuring access to safe and effective substance use
disorder treatment. The changes created by this final rule are
expansive but are focused on permanently implementing the existing
flexibilities and updating policies and practices that are based on
evidence. In this way, SAMHSA believes that much of what is contained
in the rule will not represent a significant burden for OTPs and, in
fact, will reduce burdens and confer many benefits to providers and
patients. The final rule, therefore, supports OTPs in their on-going
provision of equitable and evidence-based care to often marginalized
patients with OUD. The final rule also is consistent with the HHS
Overdose Prevention Strategy and the National Drug Control Strategy,
both of which call for increasing access to and the uptake of evidence-
based treatments for substance use disorders.\17\
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\14\ Tanz LJ, Dinwiddie AT, Snodgrass S, O'Donnell J, Mattson
CL, Davis NL. A qualitative assessment of circumstances surrounding
drug overdose deaths during the early stages of the COVID-19
pandemic. SUDORS Data Brief, No 2. Atlanta, GA: Centers for Disease
Control and Prevention, U.S. Department of Health and Human
Services; 2022.
\15\ See https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
\16\ See https://www.hhs.gov/about/news/2023/05/09/fact-sheet-end-of-the-covid-19-public-health-emergency.html
\17\ See https://www.hhs.gov/overdose-prevention/. See also
https://www.whitehouse.gov/briefing-room/statements-releases/2022/04/21/fact-sheet-white-house-releases-2022-national-drug-control-strategy-that-outlines-comprehensive-path-forward-to-address-addiction-and-the-overdose-epidemic/
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B. Background
As of June 2023, there are over 2,000 OTPs in the United States,
providing care to over 650,000 patients.\18\ These are the only
settings within which methadone, a schedule II opioid receptor agonist,
can be legally provided to patients with OUD outside the context of
hospital admission or certain other special circumstances.\19\
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\18\ Data from the U.S. Department of Health and Human Services,
Treatment Locator, at https://findtreatment.gov/
\19\ See 21 CFR 1306.07.
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An OTP is an accredited treatment program with SAMHSA certification
and Drug Enforcement Administration (DEA) registration to administer
and dispense opioid agonist medications that are approved by FDA to
treat OUD. Such medications include methadone, buprenorphine, a
schedule III partial opioid receptor agonist, and naltrexone which is
an opioid receptor antagonist. For purposes of certification, OTPs must
also offer adequate medical, counseling, vocational, educational, as
well as other assessment and treatment services either onsite or by
referral to an outside entity or practitioner.\20\
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\20\ Substance Abuse and Mental Health Services Administration.
(2015). Federal guidelines for opioid treatment programs. HHS
Publication No. (SMA) PEP15-FEDGUIDEOTP. Rockville, MD: Substance
Abuse and Mental Health Services Administration.
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Practitioners treating OUD and the OTPs in which they practice must
continuously adapt to evolving patterns of drug misuse. This is
increasingly
[[Page 7530]]
complicated by changes in controlled medication prescribing practices,
supply chains and patterns of drug use. Indeed, the early opioid
epidemic of the 1990s was characterized by an increased supply of
prescription opioids.\21\ By 2010, however, the U.S. began to see rapid
increases in overdose deaths involving heroin \22\ and then by 2013,
synthetic opioids other than methadone--primarily illicitly
manufactured fentanyl--contributed to a further rise in overdose-
related deaths.23 24 The introduction of xylazine into the
illicit drug supply and its associated harms further adds to an
evolving, complex, and dangerous situation.\25\
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\21\ Centers for Disease Control and Prevention (CDC). Vital
signs: overdoses of prescription opioid pain relievers--United
States, 1999-2008. MMWR MorbMortal Wkly Rep. 2011 Nov 4;
60(43):1487-1492.
\22\ Rudd RA, Paulozzi LJ, Bauer MJ, Burleson RW, Carlson RE,
Dao D, Davis JW, Dudek J, Eichler BA, Fernandes JC, Fondario A.
Increases in heroin overdose deaths--28 states, 2010 to 2012.MMWR
MorbMortal Wkly Rep. 2014 Oct 3; 63(39):849.
\23\ Gladden RM, Martinez P, Seth P. Fentanyl law enforcement
submissions and increases in synthetic opioid-involved overdose
deaths--27 states, 2013-2014. MMWR MorbMortal Wkly Rep. 2016;
65:837-43.
\24\ O'Donnell JK, Gladden RM, Seth P. Trends in deaths
involving heroin and synthetic opioids excluding methadone, and law
enforcement drug product reports, by census region--United States,
2006-2015. MMWR MorbMortal Wkly Rep. 2017; 66:897-903.
\25\ See https://www.samhsa.gov/sites/default/files/colleague-letter-xylazine.pdf.
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The isolation, anxiety and reduced access to resources experienced
by many during the COVID-19 pandemic has exacerbated substance misuse
and overdose deaths. According to provisional data from the Centers for
Disease Control and Prevention (CDC), a predicted 109,940 Americans
died from a drug overdose in the 12-month period ending in January
2023.\26\ Synthetic opioids (primarily illicitly manufactured fentanyl)
appear to be the principal driver of overdose deaths, increasing 55
percent from 2019 to 2020 and further increasing 26 percent from 2020
to 2021.\27\ Overdose deaths involving cocaine also increased by 22
percent from 2019 to 2020. These deaths are likely linked to co-use or
mixing (by illicit producers) of cocaine with illicitly manufactured
fentanyl or heroin.\28\ The rise in fentanyl use or exposure,
concurrent substance misuse, as well as overdose deaths, necessitates
changes to part 8 that expand access to care, and promote engagement in
OTP services, while also maintaining oversight and accreditation
activities. Oversight and accreditation standards are supported as a
means of promoting evidence-based care, while minimizing diversion and
adverse patient and public health outcomes.
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\26\ Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional
drug overdose death counts. National Center for Health Statistics.
2023.
\27\ Wide-ranging online data for epidemiologic research
(WONDER). Atlanta, GA: CDC, National Center for Health Statistics;
2023. Available at https://wonder.cdc.gov.
\28\ Ibid.
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C. Regulatory Background
On January 17, 2001 (66 FR 4075), the Department issued final
regulations for the use of opioid agonist medications (referred to as
narcotic drugs at that time) in treatment and withdrawal management
(referred to as detoxification at that time) of OUD. The final rule
repealed the treatment regulations enforced by the Food and Drug
Administration (FDA), and created a new regulatory system based on an
accreditation model. In addition, the final rule shifted administrative
responsibility and oversight from the FDA to SAMHSA. This rulemaking
initiative followed a 1995 study, `Federal Regulation of Methadone
Treatment' \29\ by the Institute of Medicine (IOM, now known as the
National Academy of Medicine) and reflected recommendations by the IOM
and several other entities to improve the treatment of OUD by allowing
for increased medical judgment in the care of patients with OUD. The
IOM report recommended that the FDA process-oriented regulations should
be reduced in scope to allow more clinical judgment in treatment and
greater reliance on guidelines. The IOM report also recommended
designing a single inspection format, having multiple elements, that
would (1) provide for consolidated, comprehensive inspections conducted
by one agency (under a delegation of Federal authority, if necessary),
which serves all agencies (Federal, State, local) and (2) improve the
efficiency of the provision of methadone services by reducing the
number of inspections and consolidating their purposes.
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\29\ For full text, see: https://www.ncbi.nlm.nih.gov/books/NBK232108/
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To address these recommendations, SAMHSA proposed a
``certification'' system based on accreditation. Under the system, an
applicant organization who intended to dispense opioid agonist
medications in the treatment of OUD must first obtain from SAMHSA, a
certification that the applicant is qualified under the Secretary's
standards and will comply with such standards. Eligibility for
certification depended upon the applicant organization obtaining
accreditation from a private nonprofit entity, or from a State agency,
that had been approved by SAMHSA to accredit OTPs.
Accreditation Bodies were directed to base accreditation decisions
on a review of an application for accreditation and on surveys (onsite
inspections) conducted every three years by OUD treatment experts. In
addition, Accreditation Bodies must apply specific opioid treatment
accreditation elements that reflect ``state-of-the-art'' opioid
treatment guidelines. Further to this, accreditation standards required
that OTPs have quality assurance systems that consider patient
outcomes.
The 2001 final regulations replaced FDA `approval' of programs,
with direct government inspection in accordance with more detailed
process-oriented regulations. These process-oriented regulations
continue to prescribe many aspects of oversight and treatment. To this
end, subpart B of the regulation addressed accreditation and includes
steps that Accreditation Bodies must follow to achieve approval to
accredit OTPs. It also set forth the Accreditation Bodies'
responsibilities, including the use of accreditation elements during
accreditation surveys. Subpart C described the sequence and
requirements for obtaining certification and addressed how and when
programs must apply for initial certification and renewal of their
certification. Subpart D elucidated the procedures for review of the
withdrawal of approval of the Accreditation Body or the suspension and
proposed revocation of an OTP certification.
Since publication of the final rule in 2001, it has been updated on
occasion to include new medications, such as buprenorphine, while also
updating or adding new rules governing the provision of such
medications. Subpart F, added in 2016, described criteria for
increasing the patient limit for those practitioners meeting Federal
requirements to prescribe buprenorphine to 275.\30\
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\30\ See https://www.federalregister.gov/documents/2016/07/08/2016-16120/medication-assisted-treatment-for-opioid-use-disorders.
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On December 29, 2022, the `Consolidated Appropriations Act, 2023'
(Pub. L. No: 117-328), was signed into law and immediately eliminated
the requirement for individual practitioners to obtain a waiver to
prescribe certain schedule III--V medications for the treatment of OUD,
commonly known as the ``DATA-Waiver.'' Before the Consolidated
Appropriations Act, 2023 was enacted, ``qualifying practitioners'' were
required to obtain waivers (formerly under 21 U.S.C. 823(h)(2))
[[Page 7531]]
from the separate DEA registration requirement, under 21 U.S.C. 823(h),
that is needed to enable dispensing of certain controlled medications
used in maintenance or withdrawal management (``detoxification'')
treatment of OUD. Section 1252(b) of the `Consolidated Appropriations
Act, 2023' (Pub. L. No: 117-328) also required removal of the one-year
history of opioid misuse prior to admission to an OTP. This was
included in the part 8 NPRM (87 FR 77330), and public comments
supported the change.
In 2001 there were close to 900 OTPs, but that number has grown to
over 2,000 by 2023.\31\ Over this period, the incidence of fentanyl
misuse has increased, escalating with the onset of the COVID-19
pandemic in early 2020. To protect the public's health and reduce the
risk of COVID-19 infection among patients and providers, SAMHSA issued
flexibilities in the provision of take-home doses of methadone and
initiation of buprenorphine via telehealth, including through audio-
only platforms, that allowed for continued treatment of OUD with
reduced direct patient contact. Each of these flexibilities represented
a significant change to previous treatment standards and are discussed
in detail below. It is important to note that SAMHSA has issued
extensions to both the initiation of buprenorphine via telehealth
flexibility and methadone take-home flexibility, effective upon
expiration of the COVID-19 Public Health Emergency, and in effect for
the period of one year from the end of the COVID-19 Public Health
Emergency, or until such time that the U.S. Department of Health and
Human Services publishes final rules revising 42 C.F.R part 8,
whichever occurs sooner.\32\
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\31\ SAMHSA treatment locator. See https://dpt2.samhsa.gov/treatment/directory.aspx.
\32\ See https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/methadone-guidance; and
https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/buprenorphine-at-opioid-treatment-programs
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Flexibility For Methadone Medication Take-Home Doses in Opioid
Treatment Programs
Among the existing standards for medication administration and
dispensing of methadone are limitations on unsupervised or ``take-
home'' use. These prior standards were established early in the history
of methadone as a medication for OUD, and the criteria for determining
whether a patient may be allowed take-home doses were restrictive,
requiring daily visits to the OTP for extended periods of time, and
adherence to strict measures of sustained stability as described in 42
CFR part 8.\33\ These criteria can pose disruption to employment,
education and other daily activities for patients, and several of the
criteria reflect outdated biases that promote stigma and discourage
people from engaging in care in OTPs.
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\33\ https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-8?toc=1.
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In March 2020, as a result of the pandemic, SAMHSA issued
exemptions that permitted State regulatory authorities to request
blanket exceptions to allow patients to take-home more doses of
methadone; 43 States and the District of Columbia did so.\34\ With this
flexibility, SAMHSA allowed OTPs to dispense up to 28 days of ``take-
home'' methadone doses to ``stable'' patients for the treatment of OUD,
and up to 14 doses of ``take-home'' methadone for ``less stable''
patients ``who the OTP believes can safely handle this level of take-
home medication.'' \35\ Although the duration of this flexibility was
not initially specified, a SAMHSA FAQ published in April 2020,
indicated that the flexibility was tied with the duration of ``the
current national health emergency . . . .'' \36\
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\34\ HHS Guidance for Opioid Treatment Programs. https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf.
\35\ See https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf.
\36\ See https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
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The intention of the methadone take-home flexibility was to reduce
the risk of COVID-19 infection among patients and providers. Beyond
this, the flexibility promotes individualized care that considers
patient characteristics and program involvement beyond time in
treatment. By reducing the burden on patients to visit the OTP daily,
this flexibility may reduce stigma for those seeking treatment, while
also providing more equitable access to care as telemedicine in OTPs is
expanded. It also allows those who reside far from an OTP or who lack
access to reliable transportation to receive treatment, while also
being able to gain or maintain employment, attend school, care for
loved ones and engage in other required activities of daily living.
The methadone take-home flexibility has been met with widespread
support among patients,\37\ OTPs,\38\ and State authorities.\39\
Patients reported that increased take-home doses of methadone left them
feeling more respected as responsible individuals.37 40 In a
national meeting, State authorities reported that the flexibilities
were appreciated by patients and OTPs alike, with no significant change
in rates of diversion seen since the COVID-19 PHE was declared.\41\
Indeed, analysis of the relevant data indicates that the actual level
of misuse, diversion or harm from methadone is more likely to occur
when it is prescribed for pain as opposed to OUD, and that the rate of
diversion is lower than that of oxycodone or hydrocodone.\42\
Additionally, a survey found that diversion of methadone is low among
patients receiving take-home doses under the COVID-19 PHE
flexibility.43 44 Further to this, analysis of data on fatal
overdoses from January 2019 to August 2021 demonstrated that this
flexibility did not lead to more deaths involving methadone.\45\
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\37\ Hatch-Maillette MA, Peavy KM, Tsui JI, Banta-Green CJ,
Woolworth S, Grekin P. Re-thinking patient stability for methadone
in opioid treatment programs during a global pandemic: Provider
perspectives. J Subst Abuse Treat. 2021 May;124:108223. doi:
10.1016/j.jsat.2020.108223. Epub 2020 Dec 5. PMID: 33342667; PMCID:
PMC8005420.
\38\ Joseph G, Torres-Lockhart K, Stein MR, Mund PA, Nahvi S.
Reimagining patient-centered care in opioid treatment programs:
Lessons from the Bronx during COVID-19. J Subst Abuse Treat. 2021
Mar;122:108219. doi: 10.1016/j.jsat.2020.108219. Epub 2020 Dec 3.
PMID: 33353790; PMCID: PMC7833302.
\39\ ``To Save Lives From Opioid Overdose Deaths, Bring
Methadone Into Mainstream Medicine'', Health Affairs Forefront, May
27, 2022.
\40\ Krawczyk, N., Rivera, B. D., Levin, E., & Dooling, B. C. E.
(2023). Synthesizing evidence of the effects of COVID-19 regulatory
changes on methadone treatment for opioid use disorder: implications
for policy. The Lancet. Public health, 8(3), e238-e246. https://doi.org/10.1016/S2468-2667(23)00023-3
\41\ The 2022 American Association for the Treatment of Opioid
Dependence (AATOD) Conference, Baltimore, Maryland, October 30--
November 3, 2022.
\42\ NIDA. 2018, June. Medications to Treat Opioid Use Disorder.
Retrieved from https://irp.drugabuse.gov/wp-content/uploads/2019/12/NIDA-Medications-to-treat-opioid-use-disorder_2018.pdf.
\43\ Figgatt, MC, Salazar Z, Day E, Vincent L, Dasgupta N. Take-
home dosing experiences among persons receiving methadone
maintenance treatment during COVID-19, Journal of Substance Abuse
Treatment, Volume 123, 2021, https://doi.org/10.1016/j.jsat.2021.108276.
\44\ Dooling, B.C.E. & Stanley, L.E. (2021). Unsupervised use of
opioid treatment medications: Report II of the extending pandemic
flexibilities for opioid use disorder treatment project. GW
Regulatory Studies Center. https://regulatorystudies.columbian.gwu.edu/unsupervised-use-opioid-treatment-medications.
\45\ Jones, C. M., Compton, W. M., Han, B., Baldwin, G., &
Volkow, N. D. (2022). Methadone-Involved Overdose Deaths in the US
Before and After Federal Policy Changes Expanding Take-Home
Methadone Doses From Opioid Treatment Programs. JAMA psychiatry,
e221776. Advance online publication. https://doi.org/10.1001/jamapsychiatry.2022.1776.
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[[Page 7532]]
Recognizing the importance of this flexibility, SAMHSA released
guidance on November 18, 2021, (subsequently updated on April 19, 2023)
\46\ that extended the methadone take-home flexibility for one year
past the end of COVID-19 PHE (May 11, 2024), or until such time that
the Department publishes this final rule, whichever occurs sooner.
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\46\ See https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/methadone-guidance
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The Opioid Treatment Program Flexibility To Prescribe MOUD via
Telehealth Without an Initial In-Person Physical Evaluation
Telehealth is a mode of service delivery that has been used in
clinical settings for over 60 years and empirically studied for just
over 20 years.47 48 49 Between 2016 and 2019, use of
telehealth, in general, doubled from 14 to 28 percent \50\ while
substance use disorder (SUD) treatment, offered through telehealth over
the same period, increased from 13.5 to 17.4 percent.\51\ This trend
has rapidly increased between 2019 and 2021, due to the COVID-19
pandemic.\52\
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\47\ Bashshur, R. L., Shannon, G. W., Bashshur, N., &
Yellowlees, P. M. (2016). The empirical evidence for telemedicine
interventions in mental disorders. Telemedicine and e-Health, 22(2),
87-113.
\48\ Lustig, T. (2012). The role of telehealth in an evolving
health care environment: Workshop summary. National Academies Press.
\49\ Mace, S., Boccanelli, A., & Dormond, M. (2018). The use of
telehealth within behavioral health settings: Utilization,
opportunities, and challenges. University of Michigan School of
Public Health, Behavioral Health Workforce Research Center.
\50\ American Medical Association (2019). Telehealth
implementation playbook. Digital Health Implementation Playbook
Series. https://www.ama-assn.org/system/files/2020-04/ama-telehealthimplementation-playbook.pdf
\51\ Uscher-Pines, L., Cantor, J., Huskamp, H. A., Mehrotra, A.,
Busch, A., & Barnett, M. (2020). Adoption of telemedicine services
by substance abuse treatment facilities in the U.S. Journal of
Substance Abuse Treatment, 117, 108060.
\52\ Melamed OC, deRuiter WK, Buckley L, Selby P. Coronavirus
Disease 2019 and the Impact on Substance Use Disorder Treatments.
Psychiatr Clin North Am. 2022 Mar;45(1):95-107. doi: 10.1016/
j.psc.2021.11.006. Epub 2021 Nov 12. PMID: 35219445; PMCID:
PMC8585604.
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The pandemic spurred use of telehealth for the treatment of OUD
with buprenorphine, a schedule III partial opioid receptor agonist.
Prior to buprenorphine's development, the only opioid agonist that
could be used to treat OUD was methadone dispensed through OTPs.
Methadone has a relatively complicated pharmacological profile,
necessitating closer observation of new patients to ensure that initial
doses do not exceed an individual's tolerance for the medication.\53\
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\53\ Substance Abuse and Mental Health Services Administration.
Medications for Opioid Use Disorder. Treatment Improvement Protocol
(TIP) Series 63 Publication No. PEP21-02-01-002. Rockville, MD:
Substance Abuse and Mental Health Services Administration, 2021.
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In response to the COVID-19 PHE, as declared by Secretary Azar on
January 31, 2020, pursuant to the authority under section 319 of the
Public Health Service Act (42 U.S.C. 247), the DEA granted temporary
exceptions to the Ryan Haight Act and DEA's implementing regulations
under 21 U.S.C. 802(54)(D), one of the seven distinct categories of
telemedicine envisioned under the statutory definition of the practice
of telemedicine. In order to prevent lapses in care, these exceptions
allowed for the prescribing of controlled medications via telemedicine
encounters even when the prescribing practitioner had not conducted an
in-person medical evaluation of the patient.
These telemedicine flexibilities authorized practitioners to
prescribe schedule II-V controlled medications via audio-video
telemedicine encounters, including schedule III-V narcotic controlled
medications approved by the Food and Drug Administration (FDA) for
maintenance and withdrawal management treatment of opioid use disorder
via audio-only telemedicine encounters, provided that such
prescriptions otherwise comply with the requirements outlined in DEA
guidance documents, DEA regulations, and applicable Federal and State
law. DEA granted those temporary exceptions to the Ryan Haight Act and
DEA's implementing regulations via two letters published in March 2020:
the March 25, 2020 ``Dear Registrant'' letter signed by William T.
McDermott, DEA's then-Assistant Administrator, Diversion Control
Division,\54\ and the March 31, 2020 ``Dear Registrant'' letter signed
by Thomas W. Prevoznik, DEA's then-Deputy Assistant Administrator,
Diversion Control Division.\55\
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\54\ William T. McDermott, DEA Dear Registrant letter, Drug
Enforcement Administration (March 25, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf.
\55\ Thomas W. Prevoznik, DEA Dear Registrant letter, Drug
Enforcement Administration (March 31, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-
022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Fina
l)%20+Esign.pdf
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Building upon this, SAMHSA implemented OTP regulatory flexibilities
designed to help address the impact of the COVID-19 pandemic on OTPs
and their patients.\56\ In April 2020, SAMHSA exempted OTPs from the
requirement to perform an in-person physical evaluation (under 42 CFR
8.12(f)(2)) for any patient who was to be treated by the OTP with
buprenorphine if a program physician, primary care physician, or an
authorized healthcare professional under the supervision of a program
physician, determined that an adequate evaluation of the patient could
be accomplished via telehealth. The duration of this exemption was
specifically tied with the ``period of the national emergency declared
in response to the COVID-19 pandemic'',\57\ and the exemption did not
include induction of methadone via telehealth technology.
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\56\ OTPs are authorized to dispense narcotic maintenance and
detoxification medication under 21 U.S.C. 823(h)(1) and regulated
under 42 CFR part 8.
\57\ See https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
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Recent research has demonstrated that telehealth can be an
effective tool in integrating care and extending the reach of specialty
providers,\58\ and that among those patients requiring treatment with
buprenorphine, there are high levels of satisfaction with the use of
telehealth services.\59\ Additionally, there are no significant
differences between telehealth and in-person buprenorphine induction in
the rate of continued substance use, retention in treatment or
engagement in services.\58\ \60\ Research also shows that there is no
significant difference in client and provider ratings of therapeutic
alliance when using telehealth technology platforms.\59\ Further to
this, research demonstrates that actions to facilitate access to
buprenorphine-based treatment for OUD during the COVID-19 pandemic were
not associated with an increased proportion of overdose deaths
involving buprenorphine.\61\
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\58\ Guille, C., Simpson, A. N., Douglas, E., Boyars, L.,
Cristaldi, K., McElligott, J., Johnson, D., & Brady, K. (2020).
Treatment of opioid use disorder in pregnant women via telemedicine:
A nonrandomized controlled trial. JAMA Network Open, 3(1), e1920177-
e1920177.
\59\ King, V. L., Brooner, R. K., Peirce, J. M., Kolodner, K., &
Kidorf, M. S. (2014). A randomized trial of web-based
videoconferencing for substance abuse counseling. Journal of
Substance Abuse Treatment, 46(1), 36-42.
\60\ Vakkalanka, J. P., Lund, B. C., Ward, M. M., Arndt, S.,
Field, R. W., Charlton, M., & Carnahan, R. M. (2022). Telehealth
Utilization Is Associated with Lower Risk of Discontinuation of
Buprenorphine: a Retrospective Cohort Study of US Veterans. Journal
of general internal medicine, 37(7), 1610-1618. https://doi.org/10.1007/s11606-021-06969-1.
\61\ Tanz, L. J., Jones, C. M., Davis, N. L., Compton, W. M.,
Baldwin, G. T., Han, B., & Volkow, N. D. (2023). Trends and
Characteristics of Buprenorphine-Involved Overdose Deaths Prior to
and During the COVID-19 Pandemic. JAMA network open, 6(1), e2251856.
https://doi.org/10.1001/jamanetworkopen.2022.51856
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[[Page 7533]]
On May 9, 2023, SAMHSA issued guidance \62\ that extended the
buprenorphine telehealth flexibility for OTPs for one year past the end
of COVID-19 PHE, or until such time that the Department publishes this
final rule, whichever occurs sooner. In the face of an escalating
overdose crisis and an increasing need to reach remote and underserved
communities, making the buprenorphine telehealth flexibility permanent
is of paramount importance. This final rule permits initiation of
buprenorphine at the OTP, by the OTP practitioner, if an OTP physician,
primary care physician, or other authorized healthcare professional
under the supervision of a program physician, determines that an
adequate evaluation of the patient can be, or was, accomplished via
audio-only or audio-visual telehealth technology.
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\62\ See: https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/buprenorphine-at-opioid-treatment-programs
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SAMHSA believes that evidence underlying the initiation of
buprenorphine using telehealth also is applicable to the treatment of
OUD with methadone, and warrants expanding access to methadone therapy
by applying some of the buprenorphine in-person examination
flexibilities to treatment with methadone in OTPs.\63\ However, SAMHSA
also acknowledges that there are differences between these two
medications. Accordingly, this final rule allows for the use of audio-
visual telehealth for any new patient who will be treated by the OTP
with methadone if a program physician, or an authorized healthcare
professional under the supervision of a program physician, determines
that an adequate evaluation of the patient can be accomplished via an
audio-visual telehealth platform. SAMHSA is not extending this change
to the use of audio-only telehealth platforms in assessing new patients
who will be treated by the OTP with methadone because methadone, in
comparison to buprenorphine, holds a higher risk profile for sedation
in patients presenting with mild somnolence which may be easier to
identify through an audio-visual telehealth platform. The final rule is
not applicable to, and does not authorize, the prescription of
methadone pursuant to a telehealth visit. Instead, this change applies
to the ordering of methadone by appropriately licensed OTP
practitioners and dispensed to the individual patient by the OTP under
existing OTP procedures.
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\63\ Chan B, Bougatsos C, Priest KC, McCarty D, Grusing S, Chou
R. Opioid treatment programs, telemedicine and COVID-19: A scoping
review. Subst Abus. 2022;43(1):539-546. doi: 10.1080/
08897077.2021.1967836. Epub 2021 Sep 14. PMID: 34520702.
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Further to this, health care providers who receive Federal
financial assistance are reminded of their obligations to ensure that
their audio-only and audio-visual telehealth platforms are accessible
to individuals with disabilities and afford an opportunity for
meaningful access for limited English proficient (LEP) individuals.
Federal civil rights laws prohibit discrimination on the basis of
disability and may require health care providers to make reasonable
modifications to their policies, practices, or procedures to ensure
that a person who is not able to use audio-visual telehealth platforms
based on their disability has an equal opportunity to benefit from
treatment with MOUD. Similarly, Federal civil rights laws prohibit
discrimination on the basis of national origin (including language
ability) and require recipients to take reasonable steps to provide
meaningful access to LEP individuals. This may require the provision of
a qualified interpreter and/or translated material, such that they have
the opportunity benefit from treatment with MOUD.
Expanding Access to Services
On June 28, 2021, the DEA introduced allowance for OTPs to add a
``mobile component'' to their existing registration and waived any
obligation for an OTP mobile medication unit complying with these
requirements to separately register at the remote locations where it
dispenses.\64\ On September 21, 2021, SAMHSA released guidance on the
establishment of mobile and non-mobile medication units and allowable
services.\65\ While part 8 currently allows OTPs certified by SAMHSA to
establish medication units (as defined under 42 CFR 8.2), the final
rule further defines mobile units and clarifies potential services,
interventions and accreditation processes.
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\64\ See https://www.federalregister.gov/documents/2021/06/28/2021-13519/registration-requirements-for-narcotic-treatment-programs-with-mobile-components.
\65\ See https://www.samhsa.gov/medication-assisted-treatment/statutes-regulations-guidelines#mobile.
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Additionally, the COVID-19 pandemic highlighted the importance of
providing harm reduction services to OTP patients. On April 7, 2021,
the CDC and SAMHSA jointly announced that Federal funding could be used
to purchase rapid fentanyl test strips (FTS) for drug checking
purposes.\66\ This was proposed in part to help curb the dramatic spike
in drug overdose deaths largely driven by the use (both intentional and
unintentional) of potent synthetic opioids, primarily illicitly
manufactured fentanyl. FTS can be used to determine if drugs have been
mixed or cut with fentanyl, providing people who use drugs and their
communities with important information about fentanyl in the illicit
drug supply so they can take steps to reduce their risk of overdose.
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\66\ See https://www.samhsa.gov/newsroom/press-announcements/202104070200
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On December 16, 2022, HHS issued a notice of proposed rulemaking
(NPRM) entitled `Medications for the Treatment of Opioid Use Disorder'
(87 FR 77330). In that NPRM, the Department proposed to modify certain
provisions of part 8 to update Opioid Treatment Program (OTP)
accreditation and certification standards, treatment standards for the
provision of medications for opioid use disorder as dispensed by OTPs,
and requirements for individual practitioners eligible to dispense
(including by prescribing) certain types of Medication for Opioid Use
Disorder (MOUD) with a waiver under 21 U.S.C. 823(h)(2). Proposed
changes sought to make flexibilities put forth during the COVID-19 PHE
permanent, and to also update standards to reflect an OTP accreditation
and treatment environment that has evolved since 42 CFR part 8 came
into effect in 2001. To this end, the Department proposed to update
part 8 by: removing outdated language; fostering a more patient-
centered perspective; and reducing barriers to receiving care. These
elements have been identified in the literature and in feedback as
being essential to promoting effective treatment and retention in care
provided by OTPs.
To expand access to care, the Department proposed to update OTP
admission criteria as described in 42 CFR part 8. This included removal
of the one-year requirement for opioid addiction before admission to an
OTP, in favor of consideration of problematic patterns of opioid use.
Indeed, evidence-based standards of care demonstrate that it is more
prudent to admit those individuals who either: meet diagnostic criteria
for active moderate to severe OUD; are in OUD remission; or are at high
risk for recurrence or overdose. In conjunction with updated standards
that include extended take-home doses of methadone and access to
telehealth, this is likely to
[[Page 7534]]
expand access while also improving retention in treatment.
Additionally, the Department proposed to update 42 CFR part 8 to
reflect evidence-based practice, treatment standards, and the workforce
currently providing services in OTPs. Proposed changes included:
expanding the definition of a treatment practitioner to include any
provider who is appropriately licensed to dispense and/or prescribe
approved medications; addition of evidence-based paradigms of care such
as split dosing, telehealth and harm reduction activities; removing
outdated terms such as `detoxification'; review of criteria for
provision of take-home doses of methadone; strengthening the patient-
practitioner relationship through promotion of shared and evidence-
based decision making; allowing for early access to take-home doses of
methadone for all patients to promote flexibility in creation of plans
of care that promote recovery activities such as employment or
education, while also allowing those with unstable access to reliable
transportation the opportunity to also receive treatment; promotion of
mobile medication units to expand an OTP's geographic reach; and review
accreditation standards. The proposed changes sought to organize
existing flexibilities and practice updates in a manner that makes them
permanent and cohesive.
Removal of DATA-Waiver Requirements
Section 1262(a)(1) of the Consolidated Appropriations Act, 2023
(Pub. L. No: 117-328), which was enacted on December 29, 2022, amended
the CSA (21 U.S.C. 823(h)) by eliminating the requirement that
practitioners obtain a waiver to prescribe certain schedule III--V
medications for the treatment of opioid use disorder (OUD). This
immediately removed the requirement for practitioners to submit a
notification of intent and to receive the Drug Addiction Treatment Act
of 2000 (DATA)-Waiver before prescribing buprenorphine.
Before the Consolidated Appropriations Act, 2023 was enacted,
``qualifying practitioners'' were required to obtain waivers (formerly
under 21 U.S.C. 823(h)(2)) from a separate registration requirement,
under 21 U.S.C. 823(h), that is needed to enable dispensing of certain
schedule II--V narcotic medications used in maintenance or
detoxification treatment. Practitioners with a waiver of this kind were
limited in the number of patients they could treat with this type of
medication at any one time.
In July 2016, SAMHSA published a final rule (81 FR 44711) that
added `subpart F' to 42 CFR part 8 under the authority of former 21
U.S.C. 823(h)(2)(B)(iii)(III). Among other things, subpart F authorized
eligible practitioners with a waiver under 21 U.S.C. 823(h)(2) to
request approval to treat up to 275 patients under certain conditions.
The December 16, 2022, NPRM entitled `Medications for the Treatment of
Opioid Use Disorder' (87 FR 77330), proposed three changes to subpart
F: (1) altering section headings to remove the current question-and-
answer style and replacing it with a standard format; (2) updating
Section 8.610 to remove stigmatizing language and to also clarify that
the 275-patient waiver is limited to three years in duration and; (3)
removing Section 8.635 to eliminate annual reporting requirements for
practitioners approved to treat up to 275 patients.
Pursuant to section 1262 of the Consolidated Appropriations Act,
2023, the Department published a supplemental notice of proposed
rulemaking (SNPRM), entitled `Medications for the Treatment of Opioid
Use Disorder: Removal of the DATA-2000 Waiver Requirements' (88 FR
9221), on February 13, 2023. This SNPRM proposed to remove in its
entirety subpart F of 42 CFR part 8 in addition to language throughout
42 CFR part 8 that specifically references or implicates the DATA-2000
waiver process.
D. Analysis and Discussion of Comments
On December 16, 2022, the Department published a notice of proposed
rulemaking entitled `Medications for the Treatment of Opioid Use
Disorder' (87 FR 77330). The public comment period ended on February
14, 2023, and a total of 373 comments were received. On February 13,
2023, the Department also released a supplemental NPRM entitled
`Medications for the Treatment of Opioid Use Disorder: Removal of the
DATA-2000 Waiver Requirements' (88 FR 9221), to bring proposed changes
to 42 CFR part 8 rule into alignment with the `Consolidated
Appropriations Act, 2023' (Pub. L. 116-260). The supplemental NPRM
closed for public comments on March 14, 2023. An additional 27 comments
were received, the majority of which pertained to the December 16,
2022, NPRM.
General Comments
Terminology Changes, and Reducing Stigma
Comments conveyed widespread approval of terminology and language
changes aimed at expanding care while also reducing stigmatization for
patients receiving treatment for OUD. Some commenters noted that
language changes alone will not be sufficient to eliminate, stigma,
injustice, and institutionalized marginalization. Others were concerned
that updated language was not accurate--for example, that it detracts
focus from other forms of treatment. One commenter additionally
suggested that SAMHSA and other authorities consider updating their
organizations' names to maintain consistency with destigmatizing
language changes. Such changes have been proposed by SAMHSA and
HHS,\67\ but not yet enacted by Congress as of this date.
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\67\ See https://www.samhsa.gov/sites/default/files/samhsa-fy-2024-cj.pdf.
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Another commenter suggested eliminating or reducing the
requirements for random toxicology testing as an important method to
further reduce stigma and loss of bodily autonomy among a population
that has often faced violent and punitive treatment. They also suggest
reexamining the differential regulation of methadone versus
buprenorphine.
Response: SAMHSA recognizes the role of language in perpetuating
stigma and discrimination, and is committed to taking steps to use
language that is positive, patient-centered, productive and inclusive.
It recognizes that changing language, alone, will not immediately
eliminate harms suffered by those struggling with and in recovery from
substance use disorders. SAMHSA and its Federal, State, local, Tribal
and territorial partners have been working to impact health equities
and promote justice through its programs, services and regulations, as
evidenced in the improvements made in this regulatory language. SAMHSA
has also emphasized support for recovery and recovery services.\68\ It
will take time to assure consistency of language throughout documents;
changing names of Federal agencies requires legislative action.
Toxicology testing is a clinical tool that is used to inform the
treatment process, should never be used punitively, and must be
conducted in a way that is respectful of the individual and in
accordance with clinical and
[[Page 7535]]
professional standards.\69\ Also, the different regulation of methadone
(in schedule II) versus buprenorphine (in schedule III) stems from how
these substances are scheduled and from how they are regulated under 21
U.S.C. 823(h), which requires ``practitioners who dispense narcotic
drugs (other than narcotic drugs in schedule III, IV, or V) to
individuals for maintenance treatment or detoxification treatment'' to
obtain an annual separate registration for that purpose.
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\68\ See https://www.samhsa.gov/find-help/recovery?
\69\ See https://store.samhsa.gov/sites/default/files/d7/priv/pep15-fedguideotp.pdf.
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Error in Citations
One commenter expressed concern that several cited research studies
were not accurately interpreted as used for this NPRM. For example,
citation 103 is used as justification for provision of counseling at
OTPs, but the study was done in a primary care setting. Another
commenter stated that the same reference, 103, is incorrect and the
citation in the body does not match the DOI link--one references HIV
testing in Africa while it appears they intend to reference the HSU
study on psychiatric comorbidity.
Response: SAMHSA made every effort to ensure that the citations
listed were correct. The error noted with citation 103 has been
rectified. Within the body of the text, the citation is appropriate as
the text explicitly describes this study and highlights that in
combination with other evidence, a comprehensive approach to treatment
is associated with improved outcomes. Indeed, the proposed rule also
includes evidence from other settings such as Emergency Departments. It
is important to note that economic analysis of OUD treatment
interventions is uncommon and so assessment of such evidence requires
consideration of all sources.
Comments on Accreditation Standards
One-Year Accreditation Following One Recommendation
Many commenters opposed the proposed change under Section 8.4, that
provides, based on their understanding, only one-year accreditations to
OTPs with recommendations. They believe this change in accreditation
regulations will essentially end three-year accreditations. Commenters
stated that with the number of standard ratable elements it is
unreasonable to expect facilities to meet every accreditation element.
With about 1,400 elements evaluated during each survey, not having even
one recommendation is an unobtainable standard for many OTPs.
Commenters stressed that having such a high standard would result in a
substantial number, if not all, of OTPs having to submit to an annual
accreditation inspection.
Response: Section 8.4 addresses the responsibilities of the
Accreditation Bodies. Since 2001, Section 8.4(b), in response to
noncompliant programs stated ``(1) If an Accreditation Body receives or
discovers information that suggests that an OTP is not meeting Federal
opioid use disorder treatment standards, or if survey of the OTP by the
Accreditation Body otherwise demonstrates one or more deficiencies in
the OTP, the Accreditation Body shall as appropriate either require and
monitor corrective action or shall suspend or revoke accreditation of
the OTP, as appropriate based on the significance of the
deficiencies.'' The proposed rule retained language about noncompliance
with one or more standards as it refined expectations for Accrediting
Bodies' follow up with these programs. Based on comments, this final
rule clarifies the intent of this subpart and survey and accreditation
requirements, while also explicitly clarifying that non-critical
findings would not result in only a one-year accreditation.
Implementation Schedule Not To Exceed 60 Days
One comment drew attention to the 33% reduction in time this
proposed change allows for submitting an implementation schedule,
pursuant to Section 8.4. The commenter believes this would introduce
significant new barriers to the delivery of care to persons with OUD
while doing nothing to improve the standard of care. Other commenters
agreed that 60 days is an insufficient amount of time to adequately
address recommendations in a manner that improves patient care.
Response: SAMHSA thanks commenters for this information. Based on
the comments, the time frames allotted for noncompliant OTPs to
implement corrections in section 8.4 were extended to 180 days. This
recognizes that some corrective measures may take more than 60 days to
successfully implement.
Surveyor Subjectivity and Need for Flexibility
In reference to Section 8.4, several commenters mentioned that
accreditation surveys are affected by the subjective interpretations of
individual auditors, and that this subjectivity contributes to their
objection to one recommendation being a preclusion for a three-year
accreditation. Some OTP guidelines may no longer be consistent with
newly proposed rules and are inconsistent with current evidence-based
practices. Further, several commenters urged flexibility in
accreditation decisions as the unique situations of many OTPs prevents
constant, exact compliance. In other words, commenters urged
flexibility in decision making based on center needs and circumstances
as well as the seriousness of the recommendation(s) and its effect on
patient care and safety.
Response: SAMHSA reviews the policies and procedures of all
Accreditation Bodies, including those related to the training and
supervision of surveyors. SAMHSA meets regularly with the Accrediting
Bodies to assure consistency in the application and interpretation of
42 CFR part 8. It also reviews the performance of Accreditation Bodies
by inspecting a selected sample of the OTPs accredited by the
respective Body each year, and, under section 8.4 will receive reports
of OTP surveys when deficiencies are discovered. Together, these help
to ensure consistency across and within Accreditation Bodies. Following
finalization of this rule, SAMHSA intends to update the 2015 Federal
Guidelines for OTPs \70\ to assure the OTP guidelines are consistent
with newly proposed rules and with current evidence-based practices.
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\70\ See https://store.samhsa.gov/sites/default/files/d7/priv/pep15-fedguideotp.pdf.
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Cost Burden
Commenters reported concern that proposed changes to accreditation,
in Section 8.4, will result in more frequent inspections, which will
require significant time and financial expenditures. Commenters
expressed their conviction that the increased frequency of inspections
will take providers away from patient care and direct the focus of both
providers and administrators away from patient needs. Furthermore,
inspections have financial costs for OTPs; some commenters asserted
that the cost to some OTPs of more frequent surveys might be more than
the OTP can financially bear. Many commenters fear that the additional
administrative and financial costs will lead to fewer OTPs and thus
reduced options for patients in dire need of treatment.
Response: SAMHSA has made changes to Section 8.4 of this final rule
to respond to commenter concerns about potentially increased rates of
one-year accreditation results. In the final rule, Section 8.4(b) has
been altered to not only clarify the criteria for one-year or three-
year accreditation, but to also
[[Page 7536]]
remove potential misunderstanding around whether a specific number of
recommendations might lead to less than three-year accreditations.
Rather than implement a specific number of recommendations that might
lead to less than three-year accreditation, the final rule determines
the length of accreditation based on the severity of the non-
compliance. With this clarification in the final rule, rates of one
year accreditation and repeat surveys are not expected to increase.
Comments on Treatment Standards
MOUD Treatment Criteria Changes
Commenters overwhelmingly conveyed support for discontinuing
requirements for a one-year history of OUD to access treatment as well
as support for those changes that update admission criteria for minors.
Some commenters also suggested that SAMHSA should remove the
requirement that individuals cannot initiate methadone treatment more
than twice a year.
Response: The final rule removes the requirement, previously at
8.12(e)(2), that minors are required to have had two documented
unsuccessful attempts at short-term ``detoxification'', or withdrawal
management, or drug-free treatment within a 12-month period to be
eligible for maintenance treatment, and that those seeking withdrawal
management, previously under 8.12(e)(4), cannot initiate methadone
treatment more than twice per year. Instead, OTPs shall ensure that
patients are admitted to treatment by qualified personnel who have
determined, using accepted medical criteria, that: the person meets
diagnostic criteria for a moderate to severe OUD; the individual has an
active moderate to severe OUD, or OUD in remission, or is at high risk
for recurrence or overdose. There is nothing stated within the Federal
regulations or statutes that limits the number of times a person can
initiate treatment with methadone or any other medication.
Interim Treatment
Comments supported extending interim treatment from 120 days to at
least 180. Commenters request the availability of interim maintenance
treatment through all OTPs and not just public and private not-for-
profit OTPs, pursuant to 8.12(j)(1). Some commentors suggested interim
treatment provision in primary care providers' offices.
Response: Interim treatment was developed to expand access to OTP
services in urgent circumstances. The proposed rule specifically
amended the duration of interim treatment from 120 days to 180 days so
that on a temporary basis, a patient may receive services from an OTP,
while awaiting access to more comprehensive treatment services.
Language pertaining to public and not-for-profit OTPs has been removed
from the final rule in order to expand access to interim treatment
among all OTPs. This is done in recognition of a need to bring
individuals into treatment and in response to public comment.
Expanding the Definition of Long-Term Care Facilities
There is widespread support among commenters for the addition of
jails and prisons under the definition of long-term care facilities at
8.11(h)(3), thus expanding the waiver of OTP certification to better
allow for equitable access to treatment and reduce the potential for
civil rights violations. Group homes and withdrawal management programs
are also mentioned by some commenters in this context, as well as any
licensed non-hospital residential treatment programs with medical
staffing, a DEA registration and the ability to administer/store/
dispense prescription medications. Several commenters also requested
the removal of waiver language that specifies the OUD diagnosis be
secondary to another condition.
Response: Language has been added to the final rule, at Section
8.11(h)(3), to highlight that these flexibilities may apply to a
correctional facility that has registered with the DEA as a hospital/
clinic. If a correctional facility has registered as a hospital/clinic,
a physician or authorized staff may administer or dispense narcotic
drugs to maintain or manage withdrawal for an inmate as an incidental
adjunct to medical or surgical treatment of conditions other than
addiction. Rules regarding controlled substance dispensing that is
outside the context of OTPs, such as waiver language that specifies the
OUD diagnosis be secondary to another condition, is beyond the scope of
this rulemaking. SAMHSA notes that the Centers for Medicare & Medicaid
Services released new guidance encouraging States to apply for a new
Medicaid re-entry Section 1115 waiver demonstration project for those
persons leaving jails and prisons that this final rule may help
facilitate.\71\
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\71\ See https://www.cms.gov/newsroom/press-releases/hhs-releases-new-guidance-encourage-states-apply-new-medicaid-reentry-section-1115-demonstration.
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Expanding Methods of Access via OTPs and Their Mobile Units
Commenters support easing pathways, under section 8.11, for opening
new OTPs by enacting changes to ease or eliminate barriers, such as
extending certification periods, providing funding opportunities, or
encouraging existing syringe service programs to grow into new OTPs.
Commenters also support expanding geographical access at current OTPs
by easing regulations on their mobile units. They remarked on
transportation challenges for people with OUD and that having access to
mobile units will assist those who otherwise might not be able to
attend a clinic in a fixed location.
Response: Recognizing the many pathways to expanding access, the
final rule makes permanent flexibilities implemented during the COVID-
19 PHE and updates the overall regulations to reflect ways in which the
accreditation and treatment environment has evolved since part 8 went
into effect in 2001. Proposed changes that facilitate delivery of
comprehensive services in mobile units, such as the use of telehealth,
have been made permanent as they reduce barriers to receiving care,
among other goals. Regulations regarding mobile units were eased by the
DEA and SAMHSA, and use of funds allocated to States under the Block
Grant were approved for use in the purchase of mobile units.\72\ Some
commenters reference State-specific regulations that limit mobile
units, but Federal OTP regulations do not preempt separate State
requirements. SAMHSA fully encourages and facilitates additional OTP
applications.\73\
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\72\ See https://www.samhsa.gov/sites/default/files/2021-letter-state-authorities-mobile.pdf.
\73\ See https://www.samhsa.gov/medications-substance-use-disorders/become-accredited-opioid-treatment-program.
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Expanding Methods of Access via Office and Community Settings
Many commenters emphasized that methadone treatment must be allowed
outside of OTPs, such as in office-based settings or dispensing in
community pharmacies, as many communities do not have access to OTPs.
Commenters asserted that this approach has been successfully
implemented in other countries and SAMHSA must work with the DEA to
move in this direction. Furthermore, this may help to address stigma
associated with and criticism of some OTPs and will help promote the
cultural view of OUD as a chronic disease that necessitates respectful
patient-centered care.
[[Page 7537]]
Response: The final 42 CFR part 8 rule only applies to dispensing
of methadone in OTPs. SAMHSA continues to work with Federal partners to
explore ways through which access to MOUD might be expanded.
Expanding the Definition of a Practitioner
There was strong support from commenters regarding expanding the
definition of providers, under Section 8.2, who are able to prescribe
or order medications. Commenters expressed that allowing licensed
practitioners, such as physician assistants, nurse practitioners, and
certified nurse midwives, will result in improved access to patients,
especially in areas with a high level of provider shortages. There was
further support to add pharmacists to the definition of qualified
providers. Commenters felt that including pharmacists as qualified
providers will further improve accessibility for people suffering with
OUD.
Response: Pursuant to the supplemental notice of proposed
rulemaking entitled `Medications for the Treatment of Opioid Use
Disorder: Removal of the DATA-2000 Waiver Requirements' (88 FR 9221)
requirements for staff credentials are finalized to include the
definition of a practitioner as ``a health care professional who is
appropriately licensed by a State to prescribe and/or dispense
medications for opioid use disorders and, as a result, is authorized to
practice within an OTP''. The scope of 42 CFR part 8 is also limited to
activities within an OTP.
One commenter requested clarification on the context of certified
nurse-midwives (CNMs) practice with MOUD. Another commenter requested
clarification on scope of practice for physician assistants and nurse
practitioners prescribing methadone, as there appear to be more
restrictions compared to buprenorphine.
Response: As noted above, the definition of a practitioner was
modified. However, not all States allow CNMs, nurse practitioners,
physician assistants, or pharmacists to order methadone unless
supervised by a physician. Notwithstanding additional flexibilities
provided in this final rule, practitioners must continue to adhere to
State requirements that may apply to the provision of methadone and
scope of practice. As also noted, this final rule does not apply to the
prescribing of methadone for OUD outside of OTPs.
Food and Drug Administration (FDA) Approval of Testing Supplies
Some commenters requested the removal of the proposed change
requiring drug testing services be FDA approved, under Section
8.12(f)(6), as this would impede their ability to test for fentanyl
with an instant testing method. Another commenter requested more
clarity, stating that this rule could preclude what they view as
medically necessary definitive testing at qualified laboratories,
despite the lack of an FDA review pathway for such testing. As the drug
supply continues to rapidly evolve, OTP medical directors need the
flexibility to use the best available tests, regardless of FDA
approval, to provide effective patient care.
Response: SAMHSA has amended Section 8.12(f)(6) to specifically
allow for distribution of testing strips for drug checking, to those
patients who wish to test their supply for adulteration, where not
prohibited by law. The final rule also clarifies that FDA approved
tests be used when conducting random drug testing with patients,
including urine or saliva samples, at the OTP.
Support for Provision of Resources With Patient-Centered Care Plans
Commenters were supportive of Section 8.12(5)(i) that requires OTPs
to work with patients to provide additional services such as counseling
and harm reduction (including education, testing, and treatment for
HIV, viral hepatitis, and sexually transmitted infections (STIs) when
helpful), but some commenters cautioned requiring provision of these
services without establishing their funding and requested in the
meantime that the language be amended to include assessment and
referral. Additionally, comments overwhelmingly conveyed support for
clarifying that attending counseling is not a condition of MOUD
treatment, and that treatment plans should be patient centered.
Response: Part 8 defines what is expected in the provision of
methadone for the treatment of OUD. Although it is expected that OTPs
plan for their fiscal viability to assure continuity of medication and
other treatment services, funding and sustainability are beyond the
scope of these regulations.
OTPs are expected to offer adequate medical, counseling,
vocational, educational, and other assessment, and treatment services
either onsite or by referral to an outside agency or practitioner. The
revisions in this final rule promote a patient-centered approach to
care that does not make medication continuity contingent upon
involvement in counseling services but fosters greater shared decision-
making. The revisions also relaxed the requirement that an OTP have a
formal documented agreement with outside agencies; under Section
8.12(f)(1) the final rule calls for a ``documented agreement'' to
provide such services.\74\
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\74\ See https://www.samhsa.gov/sites/default/files/dear-colleague-letter-fda-samhsa.pdf.
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Further Consideration of Tribal Communities
Some commenters advocate for increased Tribal sovereignty by
including Indian Tribes as potential Accreditation Bodies.
Additionally, while the Indian Health Service is included in the list
of exceptions for State law compliance, OTPs operated by Indian Tribes
must also be included to align with Tribal sovereignty. Accordingly,
when States or ``State law'' is referenced, they urge SAMHSA to also
include Tribes or ``Tribal law''.
Another commenter communicates concern about lack of safe
transportation and funding to access treatment on some Tribal
reservations, institutionalized racism and marginalization, as well as
lack of positive integration of American Indian/Alaska Native culture
into treatment for those populations. The commenter indicates that it
is vital that SAMHSA alter the rule to explicitly include addressing
the needs of marginalized communities, including Tribes and Tribal
entities.
Response: SAMHSA recognizes the need for culturally supportive care
that addresses race, ethnicity, Tribal sovereignty, sexual orientation,
religion and gender identity, and social determinants of health, such
as housing and transportation, that may pose barriers to treatment
engagement, or harm reduction and recovery support service needs.
Patient-centered language in the NPRM was finalized in this rule to
ensure that the care provided is consistent with the patient's needs,
and self-identified goals for treatment and recovery. SAMHSA encourages
OTPs serving American Indians and Alaska Natives to implement
culturally competent and patient-centered care. SAMHSA notes that it
and other agencies have developed resources that
[[Page 7538]]
may be helpful in developing culturally sensitive approaches for AI/AN
populations.\75\
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\75\ See https://www.samhsa.gov/behavioral-health-equity/ai-an.
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The Department has not included `Tribal law' whenever `State law'
is referenced, as Tribal laws vary widely. Accordingly, understanding
what the reference means, or its scope, in some situations may be
ambiguous. Therefore, it would be inappropriate to include Tribal law
in this context.
Intake
Commenters requested clarification on the application of the new
intake rules under Section 8.12(f)(2). Some commenters requested that
clarification include explicit descriptions of rule application to
clinical scenarios such as care transitions from hospital or non-OTP
settings to OTPs. Commenters were supportive of allowing non-OTP
clinicians to complete the intake screening and full examinations to
expedite access during this process, though some commentors specified
that the OTP provider must later review and approve the exams completed
outside of an OTP. Some commentors stated that more frequent regular
medical exams may be helpful during the first year of treatment to
ensure safety and efficacy of treatment. One commenter requested
clarification as to whether the full physical exam includes a mental
status exam or an assessment of psychiatric symptoms, due to the high
incidence of such symptoms among these patients. Another commenter
requested clarity as to whether methadone may be initiated during the
14-day grace period for full OTP intake and screening/full examination,
as some State regulations interpret this differently.
Response: The final regulations, under Section 8.12(f)(2)(a),
facilitate initial screening to allow for medication to commence at
time of initial intake; SAMHSA recommends methadone medication
induction not be delayed until the full examination is completed.\76\
The purpose of the initial screening is to ensure that there are no
contraindications to prescribing methadone; this may require a
psychiatric screening or evaluation of psychiatric symptoms, if
clinically indicated. If mental health is not assessed at the time of
screening, it should be completed subsequently as part of the patient's
assessment to identify any service needs. Proposed regulations were
finalized as written, since they explicitly address these comments.
---------------------------------------------------------------------------
\76\ Substance Abuse and Mental Health Services Administration.
Medications for Opioid Use Disorder. Treatment Improvement Protocol
(TIP) Series 63 Publication No. PEP21-02-01-002. Rockville, MD:
Substance Abuse and Mental Health Services Administration, 2021.
---------------------------------------------------------------------------
Commenters were concerned about the requirement to complete a
psychosocial assessment within 14 days, stating that patients often
experience instability at the time of entry into treatment, which makes
this difficult; some commenters suggest providing 30 days to complete
the assessment. One commenter also requested an exception be provided
to ensure patients diagnosed with OUD are not excluded from MOUD
because of documented failure or that only documentation of reasonable
effort to complete this assessment is required. Another commenter adds
that this short, prescriptive timeframe is not always conducive to
developing therapeutic rapport between patients and providers and may
force programs to be overly restrictive, disrupting patient engagement
at a critical time.
Response: Patients entering treatment for OUD are often in crisis
and this is the basis for the requirement that a complete psychosocial
assessment be conducted within 14 days. This is especially important
because the final rule allows patients new to treatment to receive up
to 7 take-home doses of methadone. The psychosocial assessment informs
part of the initial examination, and as such, it is the basis of
continued assessment and management as indicated. There is no
requirement for a definitive list of diagnoses to be created at this
time. Rather, this is an opportunity to create a detailed plan of care
which might include continued assessment and monitoring of psychosocial
status. To facilitate timely completion of the assessment, the final
rule includes flexibilities for the use of telehealth.
Serology Testing
For serology testing, comments recommend the patient should
explicitly retain the right to refuse or defer testing unless the
medical provider deems it necessary for patient safety. Others asked
for clarification on the deadline (14-day or 30-day) stating that 8.12
(f)(2)(B)(iii) and (iv) as proposed appeared contradictory.
Response: An individual patient always has the right to refuse
testing, and this provision therefore has been clarified in the final
rule. Specifically at 8.12(f)(2)(i)(b), now states that a ``patient's
refusal to undergo lab testing should not preclude them from access to
treatment, provided such refusal does not have the potential to
negatively impact treatment with medications''. In regard to the
suggested 14-day or 30-day discrepancy, these timeframes refer to use
of serology results: it is permissible to use serology results drawn no
more than 30 days prior to admission to the OTP, or up to 14 days after
admission to the OTP to complete the full examination. Thus, these two
provisions are not inconsistent.
Treatment Discharge Concerns
Several comments expressed concern over removal of language in the
proposed rule concerning discharge, asserting that this change removes
important patient protections that have helped to promote humane
discharge processes. Whether patients are discharged for nonpayment or
other reasons, commenters emphasize that tapering schedules must be
based on clinical and safety considerations.
Response: The importance of discharge planning has been highlighted
in the final rule. Specifically, under Section 8.11(f)(2)(iv) discharge
decisions have been enumerated to require a patient-centered approach.
Such decisions must be documented, and planned in a manner that
ensures, to the greatest extent possible, that patient treatment is not
disrupted. Proposed language from the NPRM pertaining to discharge
planning throughout Section 8.12 has been finalized.
Split Dosing
Numerous commenters support the expansion of split dosing for all
OTP patients receiving take-home doses, defined in Section 8.2, based
on the clinical judgement of the OTP practitioner, and urge SAMHSA to
add language specifying that additional testing and submission of
documentation for split dosing is unnecessary if the clinician has
clearly documented in the medical record that split dosing will benefit
the patient. Commenters also emphasize that take-home doses are
essential for split dosing, especially for pregnant patients and
patients driving long distances to receive medication.
Response: The final rule does not specify requirements of any
additional testing or documentation beyond that of routine clinical
practice. There is nothing in the final rule that precludes provision
of split doses for take-home doses of methadone.
Dosage During Treatment Induction
At Section 8.12(h)(3)(ii) commenters emphasize that higher initial
and next day doses are often clinically appropriate and necessary to
prevent withdrawal and treatment attrition,
[[Page 7539]]
especially for patients exposed to fentanyl, as well as for patients in
the later stages of pregnancy, and that clinicians require more
clarification on this. Commenters questioned whether the additional
medication is administered as one higher dose or additional,
incremental dose(s) at several hour interval(s). They worry that lack
of clarity will result in underutilization and thus lower treatment
retention. Some commenters suggest eliminating induction dosing
guidelines (which they view as a reflection of longstanding stigma and
discrimination against patients in OTP treatment). These commenters
suggest entrusting these decisions to practitioners, noting that other
medication dosage decisions for many medical conditions are left to
judgment and discretion of medical providers. Some commenters also
caution that higher induction doses must not be discouraged when
medically necessary for efficacious treatment.
Response: A primary purpose of the final rule is to promote use of
clinical judgement as well as patient-centered care. These comments
speak to the need for ``shared decision-making'' in the practitioner-
patient relationship, and the final rule supports this through
empowering practitioners to work with patients to create individualized
plans of care. Section 8.12(h)(3)(ii) has been clarified in a manner
that does not prohibit higher induction doses, but requires the
rationale for higher induction doses to be documented in the patient's
record.
Audio-Only Telehealth
Commenters emphasize that audio-only telehealth is an important
permanent provision for counseling and buprenorphine initiation to
ensure more equitable access to OTPs.
Response: SAMHSA agrees with commenters that telehealth, including
audio-only telehealth, can be an important tool to enhance access to
treatment. SAMHSA also recognizes scientific evidence that further
supports integration of telehealth provisions in the final rule
consistent with clinical guidelines and safety requirements. The final
rule accordingly states that in evaluating patients for treatment with
schedule III medications (such as Buprenorphine) or medications not
classified as a controlled medication (such as Naltrexone), audio-
visual or audio only platforms may be used at the patient and
provider's preference. For schedule II medications (such as Methadone),
the rule allows for audio-visual telehealth initiation by the OTP
practitioner. When audio-visual technologies are not available or their
use is not feasible for a patient, it is acceptable to use audio-only
devices, but only when the patient is in the presence of a licensed
practitioner who is registered to prescribe (including dispense)
controlled medications. This is because, as noted, in the proposed
rule, schedule II medications such as methadone pose increased risk
compared to schedule III medications such as buprenorphine. In all
cases, medications for the treatment of OUD shall be ordered by the OTP
practitioner.
Audio/Visual Telehealth for Medical Intake and ``Annual Physical''
Appointments
Video-based telehealth, under section 8.12(f)(2)(B)(v), is
overwhelmingly supported by commenters for medical intake, periodic
medical assessments, and methadone or buprenorphine initiation by OTP
practitioners. Onsite staff can supplement telehealth care by gathering
vital sign and toxicology data, when necessary. One comment questioned
if any appropriate limits, for example on the number of patients a
single physician could oversee via telehealth should be added.
Response: SAMHSA appreciates these comments and has finalized
proposed changes in the final rule. Requirements pertaining to
telehealth, including the number of patients that a practitioner may
see, are governed by applicable State and Federal laws. As noted above,
however, provisions in this final rule support use of telehealth as
part of patient treatment.
Take-Home or Unsupervised Doses
Provisions expanding take-home or unsupervised methadone medication
doses, under Section 8.12(i), are mostly supported, with commenters
citing increased patient autonomy and pride, improved outcomes and
treatment retention, and reduced barriers to treatment. The removal of
the eight take-home criteria is accordingly supported by some, though
others note that toxicology testing is important to help maintain
public and patient safety. Some commenters expressed concern about
potentially increased diversion, while another commented that diversion
is a sign of unmet community need and should be addressed as such,
rather than criminalized. Some commenters worried that the revised
take-home allowances are too flexible and some proposed different
guidelines; others supported them or even wanted them eliminated
entirely, trusting providers with that responsibility. Yet, other
commenters worried that leaving decisions about take-homes completely
to the discretion of providers could result in provider abuse and
suggested that some parameters are necessary.
Many commenters expressed frustration that not all patients receive
equitable access to take-homes, whether for insurance reasons or lack
of clinic/state implementation. Some commenters suggest the addition of
take-home metrics during the OTP survey process to help address this.
Another commenter suggested SAMHSA provide a method of recourse for
patients dissatisfied with decisions made about their take-home
eligibility. One commenter requested clarification on insurance
coverage of take-home doses, specifically with Medicare or Medicare
Part D. One commenter asked that SAMHSA end the requirement for
requested program exceptions when closing or dispensing extra take-home
doses for weather emergencies and state holidays, and that patient
suitability documentation for days the clinic is closed is only
required for patients denied take-home medication.
Response: SAMHSA recognizes that its proposed provisions concerning
take-homes were significant. Proposed changes have been finalized
without alteration. While this approach promotes practitioner
discretion, determining risk factors and preventing diversion has
required team input since the original regulations were promulgated
over 20 years ago.
A standard for treatment that is common to all Accreditation Bodies
is that OTPs have policies regarding patient complaints and procedures
that protect patients from retaliation. SAMHSA requires that
Accreditation Bodies have policies and procedures in place to respond
to complaints received from the Secretary, patients, facility staff,
and others. Therefore, patients who have complaints about take-homes
shall have access to recourse through required patient complaint and
grievance procedures.
Determinations about insurance coverage and reimbursement for MOUD,
while important, are outside the scope of this rulemaking.
Need for More Data
Several commenters expressed an ongoing need for more data to
ensure treatment changes (such as additional take-home medication
doses, induction dosing schedules, expansion of the definition of a
qualified provider) are safe, especially post COVID-19 public health
emergency (PHE) as circumstances and environments change. Some had
concerns that changes provided too much flexibility,
[[Page 7540]]
especially with respect to take-home doses during the first week(s) of
treatment, due to less patient stability/functionality during this
transitional period. Others mentioned that patients might handle
medications differently outside of the COVID-19 PHE environment, due to
lack of behavior-modifying factors present during the PHE, such as
isolation and fear for continued treatment. Other commenters expressed
the need for more data related to induction dosing and best practices
for rapid induction to effective doses while minimizing risk.
Response: Data is important to performance monitoring and
evaluations of health care interventions. Accreditation standards
require that OTPs have quality assurance systems that consider patient
outcomes. The data related recommendations noted in these comments are
items that could be incorporated into the OTPs quality assurance
processes. These recommendations are better addressed in the revision
of the Federal OTP guidelines that SAMHSA will complete following this
rulemaking. SAMHSA and its partners, including the Centers for Disease
Control and Prevention, FDA and National Institutes of Health (NIH),
support further research on these issues, and SAMHSA will monitor the
impact of this rule. As one example, FDA, SAMHSA and the Reagan-Udall
Foundation held a meeting in May 2023 regarding `Considerations for
Buprenorphine Initiation and Maintenance Care' to ``explore real-world
experiences and scientific evidence for buprenorphine initiation
strategies as well as medication dosing and management during continued
treatment across different care settings.'' \77\ SAMHSA and NIH
similarly collaborate to support the Helping to End Addiction Long-
term[supreg] Initiative which focuses on improving pain treatment and
developing community-level solutions to opioid addiction.\78\ SAMHSA
will continue on its own and with other agencies and stakeholders to
explore and support research on these issues.
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\77\ See https://reaganudall.org/news-and-events/events/considerations-buprenorphine-initiation-and-maintenance-care.
\78\ See https://heal.nih.gov/.
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Pregnancy Testing
Several commenters advised against requiring pregnancy testing,
under Section 8.12(f)(B)(iii), for pregnant OTP patients. They reasoned
that, in a time when States are increasingly restricting and even
criminalizing reproductive options, pregnancy testing may dissuade
patients of child-bearing potential from seeking treatment.
Response: Pregnancy testing is often necessary for appropriate
clinical care, and the final rule clarifies that pregnancy testing
should be requested only when clinically appropriate, and that refusal
of such testing should not preclude access to treatment. Safeguarding
patient privacy and health is essential, and in all cases, providers
must adhere to State and Federal laws and regulations, clinical
requirements and professional guidelines when considering screening and
disclosure of testing results. For instance, the 2015 `American College
of Obstetricians and Gynecologists policy on Alcohol Abuse and Other
Substance Use Disorders: Ethical Issues in Obstetric and Gynecologic
Practice', emphasizes the importance of patient informed consent for
testing.\79\
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\79\ See https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2015/06/alcohol-abuse-and-other-substance-use-disorders-ethical-issues-in-obstetric-and-gynecologic-practice.
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Ramifications of Dependency Diagnosis
One commenter expressed concern that under Section 8.12(f)(2), all
patients receiving opioids must be documented in the medical chart with
an opioid dependence diagnosis, even if the patient is a pain patient
and the doctor has no dependency concerns. One commenter is concerned
that this could affect eligibility for future organ transplants.
Response: These regulations establish the procedures by which the
Secretary of HHS determines whether a program is qualified to dispense
methadone and other medications in the treatment of opioid use
disorders and standards regarding the use of these medications for
treatment purposes, in accordance with the Controlled Substances Act
(CSA) under 21 U.S.C. 823(h). As a result, a diagnosis of opioid use
disorder is required. SAMHSA notes that opioid dependence is an older
diagnostic term that, in the U.S., has been replaced with the
diagnostic term of opioid use disorder and associated diagnostic
criteria. Proposed changes, as written, were finalized in the rule.
Protecting Patient Data
Central registries are often queried to detect and prevent
potential multiple enrollments in more than one OTP. Central registries
are briefly described in 42 CFR part 2 (Confidentiality of Substance
Use Disorder Patient Records) regulations, but one commenter is
concerned that there do not appear to be limits on their collection and
sharing of sensitive patient information and requests regulations
better clarify appropriate practices.
Response: Central registries are State-based operations. Although
the patient information is protected, procedures for assuring
protection and relevant regulations such as 42 CFR part 2 and the
Health Insurance Portability and Accountability Act are outside the
scope of these Part 8 regulations.
Alignment of State and Federal Guidelines
There were many commenters that expressed concerns with State
regulations as they intersect with proposed SAMHSA changes. If States
have more restrictive regulations, especially related to medication
administration, for instance, then patients in those States may not
benefit from Federal changes, some commenters asserted. These
commenters urged that States be required to align with Federal
regulations, even if it means withholding funds to States who refuse to
adopt new Federal regulations. Some commentors also requested language
be added mandating State Opioid Treatment Authorities (SOTAs) are
included in communications such as when and how an OTP is not meeting
standards, withdrawal of approval of Accreditation Bodies, and others.
Response: These rules do not mandate that States promulgate less
restrictive rules to match provisions of Federal law that may provide
more flexibility. SAMHSA works closely and collaboratively with the
SOTAs and State mental health and substance use disorder treatment
authorities, the Accreditation Bodies, as well as other Federal
agencies to encourage State and Federal alignment and information-
sharing.
Other Themes
There were two comments that urged keeping Levomethadyl acetate
(LAAM) on the list of approved treatment medications. These comments
suggested that research could indicate it is an effective treatment for
opioid use disorder and that it may soon be available for use again.
Additionally, other comments advocated integration of other FDA-cleared
treatment options like neuromodulation and other medical technology.
Response: Currently, LAAM is not available in the United States.
For this reason, it was removed from the list of currently approved and
available medications for OUD. The list provided in the rule is
current, and there is nothing that precludes changes to the list of
medications used to treat OUD in the future. Technology is not
currently
[[Page 7541]]
addressed in 42 CFR part 8 as devices and available applications are an
adjunct to treatment with MOUD. SAMHSA will monitor the development and
approval of new medical devices by FDA for the treatment of chronic
opioid use disorder and will consider updates to part 8 as needed.
E. Summary of the Final Rule
The Department has finalized the following changes to 42 CFR part 8
that revise, delete, replace, or add sections. This section summarizes
changes in the final rule, and discusses changes made after review of
public comments on the NPRM entitled `Medications for the Treatment of
Opioid Use Disorder' (87 FR 77330), and the SNPRM entitled `Medications
for the Treatment of Opioid Use Disorder: Removal of the DATA-2000
Waiver Requirements' (88 FR 9221).
1. Title
The Department has finalized the title, originally proposed in the
NPRM, as being: Medications for the Treatment of Opioid Use Disorder.
As discussed in the NPRM, this title reflects current medical
terminology and removes stigmatizing language. The term `opioid use
disorder' more precisely reflects the diagnosis for which medications
are indicated. Further to this, the terms `maintenance' and
`detoxification' reference outdated terminology that has potentially
hindered adoption of evidence-based treatments for OUD.\80\ The amended
title reflects current medical terminology and highlights that OUD is a
chronic, treatable condition.
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\80\ NIDA. 2021, November 29. Words Matter--Terms to Use and
Avoid When Talking About Addiction. Retrieved from https://nida.nih.gov/nidamed-medical-health-professionals/health-professions-education/words-matter-terms-to-use-avoid-when-talking-about-addiction.
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2. Subpart A
Reorganization of subpart A, as proposed in the NPRM and SNPRM, has
been finalized and includes the scope and definitions.
3. Section 8.1--Scope
Pursuant to the NPRM and SNPRM, Sec. 8.1 is finalized to reflect
modern medical terminology, to detail updated acronyms, and for
clarity. Of note, the term medication assisted treatment (MAT) has been
updated to medications for opioid use disorder (MOUD), and the term
treatment program has been changed to opioid treatment program
throughout the final rule. Pursuant to proposed changes set forth in
the SNPRM entitled `Medications for the Treatment of Opioid Use
Disorder: Removal of the DATA-2000 Waiver Requirements' (88 FR 9221),
reference to subpart F has been removed.
4. Section 8.2--Definitions
Changes proposed by the NPRM and SNPRM have been finalized in Sec.
8.2 to add, remove and update definitions. Added definitions include:
care plan; harm reduction; individualized dose; long-term care
facility; recovery support services; split dosing; and telehealth.
Existing definitions updated include: comprehensive treatment;
medication for opioid use disorder; and practitioner. The term
detoxification treatment is removed and replaced with withdrawal
management. Definitions for additional credentialing, approval term,
covered medications, and emergency situation have been removed.
5. Section 8.3--Application for Approval as an Accreditation Body
Changes proposed by the NPRM are finalized to include details of
policies and procedures expected of Accreditation Bodies, particularly
that Accreditation Bodies shall include staff physician(s) with
experience in treating OUD with MOUD in their survey team. Furthermore,
this regulation is updated, pursuant to the NPRM, to ensure that
Accreditation Bodies provide training policies specifically related to
training of survey team members. As described in the NPRM, the final
rule also provides for Indian Tribes, in addition to State or
territorial governments, to apply for approval as an Accreditation
Body.
6. Section 8.4--Accreditation Body Responsibilities
In response to public comments, language that clarifies SAMHSA's
oversight of Accreditation Bodies, and associated expectations, has
been updated and finalized. To this end, the Department has provided
clarification on the steps to be taken by Accreditation Bodies in
response to OTPs that are found to not be complying with accreditation
or certification standards, such as follow up on corrective measures
and confirmation of timely corrections. In particular, section 8.4(b)
of the final rule includes: provisions requiring categorization of the
types of non-compliance; provisions that differentiate between
accreditation duration based on the severity of non-compliance; and
adds provisions detailing procedures for severe non-compliance. Time
frames for submission of survey reports are also finalized. Pursuant to
the NPRM, the Department has finalized the requirement that all records
of accreditation activities be made available to SAMHSA upon request.
Current requirements regarding Accreditation Body follow up on
complaints are maintained but, as per the NPRM, the final rule adds a
requirement that Accreditation Bodies notify SAMHSA of all aspects of a
complaint response within 5 days of receipt. Similarly, the previous
rule requiring surveyors to recuse themselves from surveys due to
conflict of interest is amended to clarify that such conflicts must be
documented by the Accreditation Body and made available to SAMHSA.
7. Section 8.11--Opioid Treatment Program Certification
This section is finalized, pursuant to the NPRM, to update
categories of certification, to clarify the requirement that OTPs
maintain certification, and to establish procedures for OTPs whose
certification has lapsed. Terms for the extension of certification are
finalized, as are the means of requesting an extension. The final rule
also updates the certification application process to reflect the shift
from paper applications to electronic submission, and the email address
for submission of supporting documents is corrected.
As described in the NPRM, the final rule removes ``Transitional
certification'' which expired as a category of certification in 2003.
Further, the wording of ``Provisional certification'' is amended to
clarify that it is a category of certification available only to new
programs that have not been previously certified, and a new category of
``Conditional Certification'' has been added for OTPs that have
received a one-year conditional accreditation status from an
Accrediting Body--an organization that has been approved by the
Secretary of HHS to accredit OTPs--in order for operations to continue
or resume as the OTP takes steps needed to achieve permanent
certification. The criteria for granting certification extensions
outside of routine certification renewals has been expanded to address
extensions needed under extraordinary circumstances. The grammar used
in describing procedures for requesting an extension was revised.
The applicability of Health Insurance Portability and
Accountability Act (HIPAA) privacy protections have been explained,
along with clarification that changes in the status of the program
sponsor or medical director must be submitted to SAMHSA in writing.
Pursuant to the NPRM, the conditions for approval of interim
treatment have been finalized to increase the duration of interim
treatment from 120 days to 180 days, with the stipulation that
[[Page 7542]]
individuals shall not be discharged without the approval of an OTP
practitioner while awaiting transfer to a comprehensive treatment
program. In response to public comments on the NPRM, availability of
interim treatment is also expanded to all OTPs. For clarity, reference
to section 1923 of the Public Health Service Act (21 U.S.C. 300x-23) is
removed. The NPRM and final rule also shifts the need to seek approval
from the `chief public health officer' of the State in which the OTP
operates to the State Opioid Treatment Authority in the State in which
the OTP operates.
As described in the NPRM, the services that can be provided in
medication units have been finalized to explicitly allow the full range
of OTP services, based on space and privacy available in the medication
unit.
8. Section 8.12--Federal Opioid Use Disorder Treatment Standards
Revisions of treatment standards, as described in the NPRM, are
finalized in order to improve access to treatment, improve patient
satisfaction and engagement in services and support use of clinical
judgment in decision-making. In several instances, stigmatizing
language such as ``legitimate treatment use'' of controlled
medications, has been removed and patient-centered language is added.
The paragraph on staff credentials, found in the NPRM, is finalized
to expand the definition of a practitioner to a ``a health care
professional who is appropriately licensed by a State to prescribe and/
or dispense medications for opioid use disorders and, as a result, is
authorized to practice within an OTP.'' The expectation that all
licensed and credentialed staff maintain licensure and/or certification
has been finalized.
Criteria for admission to treatment, as discussed in the NPRM,
removes reference to the Diagnostic and Statistical Manual of Mental
Disorders (DSM) IV and eliminates the requirement for a one-year
history of OUD. Instead, the final rule specifies that the individual
should either: meet diagnostic criteria for active moderate to severe
OUD; that the individual may be in OUD remission; or at high risk for
recurrence or overdose. The section is finalized to ensure that the
basis for the admission decision is documented in the patient's record.
In recognition of the use of telehealth and its limitation in obtaining
physical signatures, the requirement to obtain written patient consent
to treatment is altered to the extent that consent may be provided
verbally or electronically, and documented as such. The requirement
that individuals under age 18 have two documented unsuccessful attempts
at short term withdrawal management (``detoxification'') or drug free
treatment is also finalized so to allow consent of a parent, legal
guardian, or responsible adult. Further to this, the rule requiring a
1-year history of OUD for people recently released from correctional
settings, pregnant patients or previously enrolled individuals has been
removed.
Throughout the document, as described in the NPRM,
``detoxification'' and the corresponding definition and standards for
short-and long-term detoxification treatment have been removed.
``Withdrawal management'' and terms for tapering from MOUD are added on
behalf of individuals who seek this approach or who elect or need to
reduce and/or discontinue MOUD.
The paragraph on ``Required services'' is finalized to incorporate
patient-centered language, establish flexible terminology, promote use
of clinical judgment, and clarify SAMHSA's expectations of OTPs. The
final rule creates the requirement that services be available that meet
patient needs, and ``shared decision making'' is added as the method to
be used in developing care plans.
The paragraph describing the initial medical examination has been
finalized, pursuant to the NPRM, to clarify the terms ``screening''
medical exam and ``comprehensive examination'', while also expanding
the qualifications of practitioners able to complete such examinations.
These include practitioners outside of the OTP (with limitations and
specific instructions). The final rule also creates criteria for lab
testing conducted prior to a screening medical exam, as well as a
permissible timeframe. The use of telehealth in undertaking the
screening medical exam and initiation of MOUD at the OTP, by the OTP
practitioner, has also been finalized in the rule. Additionally, the
paragraph on special services for pregnant people is finalized to
specify that confirmation of pregnancy should be requested for priority
treatment admissions. The option to use split dosing for patients, as
described in the NPRM, is also finalized.
The components of initial and periodic medical examinations have
been finalized, pursuant to the NPRM, to incorporate assessment of
behavioral health, risk of self-harm or harm to others, and to specify
time frames for completion of the care plan. Areas of psychosocial
assessment are finalized so as to assure information is gathered in the
context of the patient's whole life such as their mental health,
housing, recovery support and harm reduction resources. Additionally,
patient-centered language has been finalized, such as ``services a
patient needs and wishes to pursue''.
The final rule expands the provision of `counseling services' that
are provided by OTPs to include psychoeducational services, harm
reduction and recovery-oriented services, and counseling and linkage to
treatment for anyone with positive test results on human
immunodeficiency virus (HIV), viral hepatitis, and other sexually
transmitted infection (STI) panels, or from OTP-provided medical
examinations. Language about services that must be provided directly or
through referral is finalized to promote a patient-centered approach to
care that does not make medication continuity contingent upon
involvement in counseling services but fosters shared decision-making
for all care plans.
The requirement that an OTP have a formal documented agreement with
outside agencies is finalized to remove the word ``formal''; the final
rule calls for a ``documented agreement'' to provide such services.
Language that addresses drug testing services has been finalized to
remove stigmatizing phrases, such as ``drug abuse'', and to remove
content on short-term withdrawal management (``detoxification'').
Further to this, the final rule clarifies that the requirement to use
drug tests that have received the Food and Drug Administration (FDA)'s
marketing authorization is limited to random drug testing using samples
obtained from patients, including urine or saliva. Pursuant to public
comments on the NPRM, the final rule does not preclude distribution of
legally permissible testing supplies, that check for adulteration of an
individual's personal drug supply.
Rules that address recordkeeping and efforts to avoid simultaneous
enrollment in multiple OTPs are finalized, as per the NPRM, to be more
declarative, such as changing the word ``review'' to ``determine''
whether or not a patient is enrolled in another OTP, and documenting
review efforts in the patient's record to demonstrate the good faith
efforts made. The final rule also expands the circumstances in which a
patient may obtain treatment at another OTP to include instances when
there is an inability to access care at the OTP of record.
As described in the NPRM, specification of disciplines authorized
to administer or dispense MOUD is removed from the final rule. LAAM,
also known as Levomethadyl acetate, is removed from the list of
treatment
[[Page 7543]]
medications because it is no longer available, and other medications
approved since prior revisions to this rule were added. In response to
public comments, the regulation of an initial dose of methadone has
been increased to 50mg on the first day, with the clarification of
allowance for higher doses if clinically indicated, and documented in
the patient's record. The rule to ensure documentation of any
significant deviation from FDA-approved labeling has been maintained in
the final rule, while redundant language was removed.
Rules on the provision of unsupervised (or take-home) doses of
methadone are finalized, as per the NPRM, to incorporate flexibilities
issued in response to the COVID-19 pandemic. In general, the final
criteria allow up to 7 days of take-home doses during the first 14 days
of treatment, up to 14 take-home doses from 15 days of treatment and up
to 28 take-home doses from 31 days in treatment. The requirement that
OTPs maintain procedures to protect take-homes from theft and diversion
is finalized, as well as patient education on safe transport and
storage of take-home doses, including documentation of the provision of
this education in the patient's clinical record.
Consistent with the conditions for approval of interim treatment,
the final rule extends the potential duration of interim treatment from
120 days to 180 days. It also clarifies the circumstances in which
interim treatment may apply and maintains priority access to
comprehensive services for pregnant individuals. The rule finalizes
removal of the requirement for observation of all daily doses during
interim treatment. It also finalizes the expectation that crisis
services and information pertaining to locally available, community-
based resources for ancillary services be made available to individual
patients in interim treatment. A requirement of a plan for continuing
treatment beyond 180 days of interim services is also finalized.
9. Section 8.13--Revocation of Accreditation and Accreditation Body
Approval
References to an OTP as a ``program'' instead of a ``facility'' are
finalized.
10. Section 8.14--Suspension or Revocation of Certification
Pursuant to the NPRM, this section finalizes the actions that
SAMHSA may take when immediate intervention is necessary to protect the
public's health or safety. The final rule specifies the administrative
actions available to SAMHSA in the event that a program sponsor, or any
employee of an OTP has: been found to have engaged in misrepresentation
in obtaining certification; failed to comply with the Federal Opioid
Use Disorder treatment standards; failed to comply with reasonable
requests from SAMHSA or from an Accreditation Body for records; or
refused a reasonable request of a duly designated SAMHSA inspector, DEA
Inspector, State Inspector, or Accreditation Body representative for
permission to inspect the program or the program's operations or its
records.
11. Subpart D--Procedures for Review of Suspension or Proposed
Revocation of OTP Certification, and of Adverse Action Regarding
Withdrawal of Approval of an Accreditation Body
References to an OTP as a ``program'' instead of a ``facility'' are
finalized.
12. Subpart F--Authorization To Increase Patient Limit to 275 Patients
This subpart and corresponding sections are removed from the final
rule, as described in the SNPRM.
Severability
The Department asserts that provisions in this final rule are
severable. If any provision of this rule, or the application thereof to
any person or circumstance is held invalid, that invalidity shall not
affect other provisions or applications of this rule that can be given
effect without the invalid provision or application.
This rule has been organized in a way that separates out the major
provisions into distinct sections and subparts. Many of the provisions
in this rule are independent of each other and could function sensibly
even without certain other provisions being in effect. For example, the
provisions in subparts A, B and C related to accreditation and
certification are distinct from the Treatment Standards enumerated in
subpart C section 8.12. Rules related to take-home dosing of methadone
are also severable from other rules, such as those regarding telehealth
and interim treatment.
If any specific provision of this rule is found unconstitutional or
invalid, the Department intends that the remainder would still operate
independently. The Department believes that each provision in this rule
offers a distinct benefit to the public, patients, and healthcare
providers. Therefore, if any specific application or provision is
invalidated, the remainder of the legally valid provisions should
remain in effect.
Regulatory Impact Analysis
The Department has examined the impact of the final rule as
required by Executive Order 12866 on Regulatory Planning and Review, 58
FR 51735 (October 4, 1993); Executive Order 13563 on Improving
Regulation and Regulatory Review, 76 FR 3821 (January 21, 2011);
Executive Order 13132 on Federalism, 64 FR 43255 (August 10, 1999);
Executive Order 13175 on Consultation and Coordination with Indian
Tribal Governments, 65 FR 67249 (November 9, 2000); Executive Order
13985 Advancing Racial Equity and Support for Underserved Communities
Through the Federal Government, 86 FR 7009 (January 25, 2021); the
Congressional Review Act, Public Law 104-121, sec. 251, 110 Stat. 847
(March 29, 1996); the Unfunded Mandates Reform Act of 1995, Public Law
104-4, 109 Stat.48 (March 22, 1995); the Regulatory Flexibility Act,
Public Law 96-354, 94 Stat. 1164 (September 19, 1980); Executive Order
13272 on Proper Consideration of Small Entities in Agency Rulemaking,
67 FR 53461 (August 16, 2002); the Assessment of Federal Regulations
and Policies on Families, Public Law 105-277, sec. 654, 112 Stat. 2681
(October 21, 1998); and the Paperwork Reduction Act of 1995, Public Law
104-13, 109 Stat. 163 (May 22, 1995).
Statement of Need
This final rule is being issued to update part 8 in response to
increasing opioid overdose deaths, exacerbated by the COVID-19
pandemic.\81\ Across the United States in 2021, 9.2 million people aged
12 or older misused heroin or misused prescription pain relievers in
the preceding twelve months.\82\ The percentage was highest among young
adults aged 26 or older (3.5 percent or 7.7 million people), followed
by adults aged 18 to 25 (3.1 percent or 1 million people). It was
lowest among adolescents aged 12 to 17 (1.9 percent
[[Page 7544]]
or 497,000 people).\83\ These numbers likely underestimate the true
prevalence of opioid misuse and opioid use disorder (OUD), since the
use of illicitly manufactured fentanyl has not to date been considered
in the National Survey on Drug Use and Health (NSDUH), and populations
likely to have high prevalence of opioid misuse and use disorder, such
as individuals in the criminal justice system, other institutionalized
settings, and individuals experiencing homelessness and not living in
shelters, are not included in the NSDUH.
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\81\ Cartus AR, Li Y, Macmadu A, Goedel WC, Allen B,
Cerd[aacute] M, Marshall BDL. Forecasted and Observed Drug Overdose
Deaths in the US During the COVID-19 Pandemic in 2020. JAMA Netw
Open. 2022 Mar 1;5(3):e223418. doi: 10.1001/
jamanetworkopen.2022.3418. PMID: 35311967; PMCID: PMC8938716.
\82\ Substance Abuse and Mental Health Services Administration.
(2022). Key substance use and mental health indicators in the United
States: Results from the 2021 National Survey on Drug Use and Health
(HHS Publication No. PEP22-07-01-005, NSDUH Series H-57). Center for
Behavioral Health Statistics and Quality, Substance Abuse and Mental
Health Services Administration. https://www.samhsa.gov/data/report/2021-nsduh-annual-national-report.
\83\ Kariisa M, Davis NL, Kumar S, et al. Vital Signs: Drug
Overdose Deaths, by Selected Sociodemographic and Social
Determinants of Health Characteristics--25 States and the District
of Columbia, 2019-2020. MMWR Morb Mortal Wkly Rep 2022;71:940-947.
DOI: https://dx.doi.org/10.15585/mmwr.mm7129e2. See also https://www.seattletimes.com/nation-world/nation/addiction-treatment-medicine-is-vastly-underprescribed-especially-by-race-study-finds/.
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Further to this, there are important equity considerations
evidenced by the data. A recent analysis by the Centers for Disease
Control and Prevention (CDC) demonstrates high levels of overdose among
non-Hispanic Black, American Indian and Alaska Native communities over
the course of the pandemic.\83\ This study showed that overdose death
rates rose 44 percent in 2020 for Black people and 39 percent for
American Indian and Alaska Native people, compared with 22 percent for
white people.\83\ Black youth ages 15 to 24 saw an 86 percent increase
in overdose deaths, the largest spike of any age or race group, while
Black men 65 and older were nearly seven times as likely than white men
to die from an overdose.\83\ It was also found that Black people were
less than half as likely as white people to have received substance use
treatment. As SAMHSA has noted, the Hispanic community also has been
adversely impacted by opioid overdoses.\84\
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\84\ Substance Abuse and Mental Health Services Administration:
The Opioid Crisis and the Hispanic-Latino 1opulatiorgent Issue.
Publication No. PEP20-05-02-002. Office of Behavioral Health Equity.
Substance Abuse and Mental Health Services Administration, 2020.
https://store.samhsa.gov/sites/default/files/pep20-05-02-002.pdf.
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Research demonstrates that MOUD can reduce mortality from overdose
by up to 59% (based on results of multivariable Cox proportional
hazards models adjusted for age; sex; baseline anxiety diagnosis;
depression diagnosis; receipt of methadone, buprenorphine, opioid, and
benzodiazepine prescriptions in the 12 months before index nonfatal
opioid overdose; and time-varying receipt of opioid prescriptions,
benzodiazepine prescriptions, withdrawal management episode, and short-
and long-term residential treatments),\85\ yet few people who may
benefit from these medications have immediate and sustained access to
them.\86\
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\85\ Larochelle MR, Bernson D, Land T, Stopka TJ, Wang N, Xuan
Z, Bagley SM, Liebschutz JM, Walley AY (2018). Medication for Opioid
Use Disorder After Nonfatal Opioid Overdose and Association With
Mortality: A Cohort Study. Ann Intern Med. Aug 7;169(3):137-145.
doi: 10.7326/M17-3107.
\86\ Winograd RP, Presnall N, Stringfellow E, Wood C, Horn P,
Duello A, Green L, Rudder T. (2019). The case for a medication first
approach to the treatment of opioid use disorder. Am J Drug Alcohol
Abuse. 2019;45(4):333-340. doi: 10.1080/00952990.2019.1605372. Epub
2019 May 14. PMID: 31084515.
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The pattern of enrollment in programs providing methadone was
established in the latter part of the 20th century.\87\ Research
reveals that the rate of methadone treatment at that time was highest
in low-income urban areas.\88\ These patterns have remained relatively
unchanged since the expansion of access to buprenorphine in 2002.
Research demonstrates that there are extensive 'treatment deserts'
where there is little to no physical access to OTPs, especially in
rural areas.\89\ SAMHSA believes that changes to part 8 will, as
described above, facilitate:
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\87\ D'Aunno T, Pollack HA. (2002). Changes in methadone
treatment practices: results from a national panel study, 1988-2000.
JAMA. 2002;288(7):850-856. doi:10.1001/jama.288.7.850.
\88\ Strain EC, Stitzer ML, Liebson IA, Bigelow GE. (1994).
Comparison of buprenorphine and methadone in the treatment of opioid
dependence. Am J Psychiatry. 1994 Jul;151(7):1025-30. doi: 10.1176/
ajp.151.7.1025. PMID: 8010359.
\89\ Mitchell P, Samsel S, Curtin KM, Price A, Turner D, Tramp
R, Hudnall M, Parton J, Lewis D. (2022). Geographic disparities in
access to Medication for Opioid Use Disorder across US census tracts
based on treatment utilization behavior. Soc Sci Med. 2022
Jun;302:114992. doi: 10.1016/j.socscimed.2022.114992. Epub 2022 Apr
28. PMID: 35512612.
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Enhanced access to medications for opioid use disorder,
such as through take-home doses of methadone and extending interim
treatment to 180 days;
Reduced stigma and discrimination based on changes to
ensure updated language and terminology;
Clarification of standards applying to Accreditation
Bodies; and
Revising Federal Opioid Use Disorder Treatment Standards.
SAMHSA notes below that these changes are associated with limited
burden as the final rule does not substantially alter reporting or
accreditation activities. The changes will support SAMHSA in its role
of overseeing Accrediting Bodies and OTPs, modernizing language and
expectations in response to current challenges and anticipated future
trends.
A. Executive Orders 12866 and 13563 and Related Executive Orders on
Regulatory Review
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects; distributive impacts; and equity). Executive Order 13563 is
supplemental to, and reaffirms the principles, structures, and
definitions governing regulatory review as established in, Executive
Order 12866.
This final rule is partially regulatory and partially deregulatory.
The Department estimates that because much of what has been finalized
does not substantially alter current practice as implemented over the
past 3 years under the COVID PHE, the final rule will not result in
significantly altered costs. Further to this, the final rule creates
efficiencies in service delivery and in administration. These include
strengthening the patient-practitioner relationship in a manner that
promotes efficient, evidence-based and patient-centered care, updating
accreditation procedures and providing a stable regulatory environment.
Additionally, the final rule makes permanent some OTP treatment
flexibilities implemented within the past three years.
B. Executive Order 13985 Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government
A recent analysis by the Centers for Disease Control and Prevention
(CDC) demonstrates high levels of overdose among Black, American Indian
and Alaska Native communities over the course of the pandemic.\90\
While these trends existed long before the COVID-19 PHE, this study
highlights that overdose death rates rose 44 percent in 2020 for Black
people and 39 percent for American Indian and Alaska Native people,
compared with 22 percent for white people.\91\ Black youth ages 15 to
24 saw an 86 percent increase in overdose deaths, the largest spike of
any
[[Page 7545]]
age or race group, while Black men 65 and older were nearly seven times
as likely than white men to die from an overdose.\90\ It was also found
that Black people were less than half as likely as white people to have
received substance use treatment.
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\90\ Kariisa M, Davis NL, Kumar S, et al. Vital Signs: Drug
Overdose Deaths, by Selected Sociodemographic and Social
Determinants of Health Characteristics--25 States and the District
of Columbia, 2019-2020. MMWR Morb Mortal Wkly Rep 2022;71:940-947.
DOI: https://dx.doi.org/10.15585/mmwr.mm7129e2.
\91\ Krawczyk, N., Rivera, B.D., Levin, E., & Dooling, B.C.E.
(2023). Synthesizing evidence of the effects of COVID-19 regulatory
changes on methadone treatment for opioid use disorder: implications
for policy. The Lancet. Public health, 8(3), e238-e246. https://doi.org/10.1016/S2468-2667(23)00023-3.
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This disparity amplifies the importance of promoting patient-
centered care that is culturally appropriate and responsive to patient
need, while also fostering a treatment environment that promotes and
sustains patient engagement. The final rule facilitates the
practitioner-patient relationship in a manner that espouses these
principles, while also expanding the reach of OTPs (through activities
such as mobile medication units) to physically engage communities that
are in need of intervention. Further to this, the final rule promotes
examination of a patient's cultural needs as they engage in treatment
services. This is consistent with evidence-based and culturally
responsive paradigms of care.
The final rule also facilitates patient engagement through
removing, at the practitioner's discretion, the requirement to attend
an OTP each day. Indeed, the ability to provide unsupervised doses of
methadone early in treatment allows those with unstable access to
transportation, for example, to focus on recovery activities in their
own community. Evidence from the past three years demonstrates safety,
as well as high patient and practitioner satisfaction with take-home
doses of methadone.\91\ This is principally because take-home doses of
methadone allow individuals the opportunity to engage in employment,
education and other activities that are supportive of recovery and
longer-term community involvement.
1. Cost-Benefit Analysis
a. Overview
The U.S. estimated economic cost of opioid use disorder ($471
billion) and fatal opioid overdose ($550 billion), prior to the
pandemic, totaled $1,021 billion.\92\ Among the 39 jurisdictions
reviewed in this analysis, combined costs of opioid use disorder and
fatal opioid overdose varied from $985 million in Wyoming to $72.6
billion in Ohio. Per capita combined costs varied from $1,204 in Hawaii
to $7,247 in West Virginia. States with high per capita combined costs
were located mainly in the Ohio Valley and New England. Across many
studies, reduced quality of life is the largest component of the cost
of opioid use disorder.\93\
---------------------------------------------------------------------------
\92\ Luo, F., Li, M., & Florence, C. (2021). State-Level
Economic Costs of Opioid Use Disorder and Fatal Opioid Overdose--
United States, 2017. MMWR. Morbidity and mortality weekly report,
70(15), 541-546. https://doi.org/10.15585/mmwr.mm7015a1. See also
https://trumpwhitehouse.archives.gov/briefings-statements/cea-report-underestimated-cost-opioid-crisis/ citing a Council of
Economic Advisors study estimating 2015 costs at $504 billion and a
Congressional study using the CDC methodology estimating 2020 opioid
crisis costs as $1.5 trillion. See https://beyer.house.gov/news/documentsingle.aspx.
\93\ Mitchell, S.G., Gryczynski, J., Schwartz, R.P., Myers,
C.P., O'Grady, K.E., Olsen, Y.K., & Jaffe, J.H. (2015). Changes in
Quality of Life following Buprenorphine Treatment: Relationship with
Treatment Retention and Illicit Opioid Use. Journal of psychoactive
drugs, 47(2), 149-157. https://doi.org/10.1080/02791072.2015.1014948.
---------------------------------------------------------------------------
A recent study showed that in the absence of treatment, 42,717
overdoses (4,132 fatal, 38,585 nonfatal) and 12,660 deaths were
estimated to occur in a cohort of 100,000 patients over 5 years.\94\ An
estimated reduction in overdoses was associated with methadone
treatment (10.7%), buprenorphine or naltrexone treatment (22.0%), and
medication treatment combined with psychotherapeutic interventions
(range, 21.0%-31.4%).\95\ Estimated decreased deaths were associated
with treatment with methadone (6%), buprenorphine or naltrexone
(13.9%), and the combination of medications and psychotherapy (16.9%).
When criminal justice costs were included, all forms of MOUD (with
buprenorphine, methadone, and naltrexone) were associated with cost
savings compared with no treatment, yielding savings of $25,000 to
$105,000 in lifetime costs per person.
---------------------------------------------------------------------------
\94\ Fairley M, Humphreys K, Joyce VR, et al. (2021). Cost-
effectiveness of Treatments for Opioid Use Disorder. JAMA
Psychiatry. 2021;78(7):767-777. doi:10.1001/
jamapsychiatry.2021.0247.
\95\ McAdam-Marx C, Roland CL, Cleveland J, Oderda GM (2010).
Costs of opioid abuse and misuse determined from a Medicaid
database. J Pain Palliat Care Pharmacother. 2010 Mar;24(1):5-18.
doi: 10.3109/15360280903544877. PMID: 20345194.
---------------------------------------------------------------------------
McAdam-Marx et al. reported in 2010 that Medicaid beneficiaries
with opioid use disorder, physical dependence on opioids, or poisoning
had nearly triple the total medical costs adjusted for baseline sample
characteristics compared to beneficiaries matched by age, gender, and
state with no opioid misuse diagnosis ($23,556 vs. $8,436; P
<0.001).\95\ The opioid dependence/abuse group (using an older version
of the Diagnostic and Statistical Manual of Mental Disorders) also had
higher prevalence of comorbidities, such as psychiatric disorders,
pain-related diagnoses, and other substance use conditions. While this
study considered overall cost, it did not address medication costs in
particular, or any impact treatment may have had on overall cost.
---------------------------------------------------------------------------
\96\ Murphy SM, Polsky D (2016). Economic Evaluations of Opioid
Use Disorder Interventions. Pharmacoeconomics. 2016 Sep;34(9):863-
87. doi: 10.1007/s40273-016-0400-5. PMID: 27002518; PMCID:
PMC5572804.
\97\ Baser O, Chalk M, Fiellin DA, Gastfriend DR (2011). Cost
and utilization outcomes of opioid-dependence treatments. Am J Manag
Care. 2011 Jun;17 Suppl 8:S235-48. PMID: 21761950.
\98\ Lynch FL, McCarty D, Mertens J, Perrin NA, Green CA,
Parthasarathy S, Dickerson JF, Anderson BM, Pating D (2014). Costs
of care for persons with opioid dependence in commercial integrated
health systems. Addict Sci Clin Pract. 2014 Aug 14;9(1):16. doi:
10.1186/1940-0640-9-16. PMID: 25123823; PMCID: PMC4142137.
---------------------------------------------------------------------------
OTPs provide comprehensive interventions including medications,
counseling and services designed to offer a whole-person approach to
care and ameliorate social determinants of health that contribute to
substance misuse. Numerous studies have demonstrated that treatment
with pharmacotherapy and counseling services can reduce overall
healthcare costs for patients with OUD.96 97 98 For example,
a 2019 analysis demonstrated that a comprehensive approach to OUD
treatment is associated with improved health and economic outcomes.\99\
This study assessed patients with OUD treated at a comprehensive
primary care center (CCP) and other Maryland facilities in a large
State Medicaid program and demonstrated cost savings with a
comprehensive approach to care. Compared to the non-CCP patient group
(n = 867), the CCP group (n = 131) had a higher 6-month buprenorphine
treatment retention rate (P <0.001), fewer hospital stays in the 12-
month follow-up period (P = 0.005), and lower total cost (US$10,942 vs.
$13,097, P <0.001) and hospital stay cost (US$1,448 vs. $4,265, P =
0.001).\100\ Other measures, including emergency department utilization
and cost, substance use-related cost, and non-buprenorphine pharmacy
cost, were not statistically different between the 2 groups. Results
suggested that patients, as well as the health care system, can benefit
from a comprehensive model of care for OUD with better treatment
[[Page 7546]]
retention, fewer hospital stays, and lower costs.
---------------------------------------------------------------------------
\99\ Hsu, Y.J., Marsteller, J.A., Kachur, S.G., & Fingerhood,
M.I. (2019). Integration of Buprenorphine Treatment with Primary
Care: Comparative Effectiveness on Retention, Utilization, and Cost.
Population health management, 22(4), 292-299. https://doi.org/10.1089/pop.2018.0163.
\100\ Mohlman MK, Tanzman B, Finison K, Pinette M, Jones C.
Impact of Medication-Assisted Treatment for Opioid Addiction on
Medicaid Expenditures and Health Services Utilization Rates in
Vermont. J Subst Abuse Treat. 2016 Aug; 67:9-14. doi: 10.1016/
j.jsat.2016.05.002. Epub 2016 May 9. PMID: 27296656.
---------------------------------------------------------------------------
These findings are consistent with a 2016 cross sectional study
that evaluated medical claims for Vermont Medicaid beneficiaries with
opioid dependence or addiction between 2008 and 2013. In their
analysis, Mohlman and colleagues determined that medication combined
with psychosocial counseling is associated with reduced general health
care expenditures and utilization, such as inpatient hospital
admissions and outpatient emergency department visits, for Medicaid
beneficiaries with opioid misuse.\100\ Two prior studies assessed data
from commercial health insurance claims on the overall health care
costs and utilization rates for those taking MOUD compared to those
treated without MOUD.101 102 The first study found that over
a five-year period, members on MOUD had 50% lower total annual health
plan costs than those who had two or more visits to an addiction
treatment setting and no treatment, and 62% lower than those with zero
or one visit for addiction treatment and no intervention.\101\ The
other study found that after a six-month period, those taking MOUD had
significantly lower overall annual health plan costs compared to those
with no medication ($10,192 vs. $14,353; p-value < 0.0001).\102\ The
difference was driven largely by lower inpatient services and non-
opioid-related outpatient services for the group receiving medication.
---------------------------------------------------------------------------
\101\ McCarty D, Perrin NA, Green CA, Polen MR, Leo MC, Lynch F
(2010). Methadone maintenance and the cost and utilization of health
care among individuals dependent on opioids in a commercial health
plan. Drug Alcohol Depend. 2010 Oct 1;111(3):235-40. doi: 10.1016/
j.drugalcdep.2010.04.018. PMID: 20627427; PMCID: PMC2950212.
\102\ Baser O, Chalk M, Fiellin DA, Gastfriend DR. (2011). Cost
and utilization outcomes of opioid-dependence treatments. Am J Manag
Care. 2011 Jun;17 Suppl 8:S235-48. PMID: 21761950.
---------------------------------------------------------------------------
The regulatory impact analysis (RIA) outlined below, relies on data
provided to SAMHSA by OTP Accreditation Bodies for the year 2020-2021.
Pursuant to 42 CFR part 8, Accreditation Bodies and OTPs are required
to submit information to SAMHSA's Center for Substance Abuse Treatment
(CSAT). The annualized burden of information collection for OTPs and
Accreditation Bodies under the rule is set forth in the tables that
follow.
This rule does not substantially alter current reporting burden
requirements, or accreditation activities. The total number of burden
hours reported in 2020-2021 for Accreditation Body respondents was
approximately 394.70 hours. The total number of burden hours for OTP
respondents during the same period was 1,868.95 hours. The annual
burden associated with this rule and the associated forms was estimated
to be 2,263.65 hours.
b. Estimated Costs of Reporting Burdens for OTPs and Accreditation
Bodies
In developing its estimates of the potential costs of the final
regulation, the Department relied substantially on recent estimates of
burden and cost pertaining to requirements set forth in 42 CFR part 8.
Hourly labor costs involved in reporting requirements vary greatly
between programs. Based on wage estimates obtained from the U.S.
Department of Labor, Bureau of Labor Statistics, and Occupational
Employment Statistics website, it is estimated that employees involved
in complying with reporting requirements range from minimum wage
($7.25) clerical workers, to counselors averaging $22.14 an hour,
managers, licensed practical nurses and registered nurses averaging
$35.36 per hour, administrators averaging $52.58 per hour, and
physicians averaging $96.26 per hour. The estimated average hourly wage
for program personnel involved in reporting requirements, calculated as
a simple mean, is $42.71. Multiplying the estimated average hourly wage
by 2.0 to account for fringe benefits and overhead costs, an estimated
hourly labor cost of $85.42 is obtained. The cost to Accreditation
Bodies for applying for initial and ongoing approval with Form SMA-163,
as well as for complying with the reporting requirements under 42 CFR
8.4 and 8.6 may be estimated at $33,672.56, using the $85.42 hourly
cost figure. The estimated total annualized cost to the treatment
program respondents for preparing the Form SMA-162 and for complying
with other reporting requirements pursuant to 42 CFR 8.11, 8.24, 8.25,
8.26, and 8.28, using $85.42 as the hourly cost figure, is $16,140.11.
----------------------------------------------------------------------------------------------------------------
Preparation
Items time (hours) Cost/hour Total cost
----------------------------------------------------------------------------------------------------------------
Form SMA-163, compliance with the reporting requirements under 394.2 $85.42 $33,672.56
42 CFR 8.4 and 8.6.............................................
Form SMA-162, compliance with other reporting requirements under 188.95 85.42 16,140.11
21 CFR 8.11, 8.24, 8.25, 8.26, and 8.28........................
Form SMA-168, Exception Request and Record of Justification 2,135 85.42 182,371.70
Under 42 CFR 8.11(h)...........................................
-----------------------------------------------
Sub total................................................... .............. .............. $232,184.37
----------------------------------------------------------------------------------------------------------------
c. Cost Pertaining to Record Keeping
The record-keeping requirements set forth in 42 CFR 8.4 and 8.12
include maintenance of the following: a patient's medical examination
when admitted to treatment; a patient's history; a care plan; any
prenatal support provided to the patient; justification of unusually
large initial doses; changes in a patient's dosage schedule; the
rationale for decreasing a patient's clinic attendance; services
provided; and documentation of physiologic tolerance.
SAMHSA believes that the record-keeping requirements are customary
and usual practices within the medical and behavioral health treatment
communities. Accreditation Bodies also maintain accreditation records
for 5 or more years as a customary and usual practice. SAMHSA has
neither calculated a response burden or a cost burden for these
activities, nor did commenters provide such information.
Costs Pertaining to Disclosure
The final rule includes requirements that OTPs and accreditation
organizations disclose information. For example, Sec. 8.12(e)(1)
requires that a practitioner explain the facts concerning the use of
MOUD to each patient. This type of disclosure is consistent with common
medical practice and is not considered an additional burden. Further,
the rule requires, under Sec. 8.4(i)(1), that accreditation
organizations shall make public their fee structure. This type of
disclosure is standard business practice and is not considered a burden
in this analysis.
[[Page 7547]]
e. Estimate of Annualized Non-Hourly Cost Burden to Respondents
The final rule does not impose new capital or startup costs beyond
the normal office and laboratory equipment required for achieving
regulatory compliance. It is estimated that there are some costs
associated with preparation for the accreditation site visit itself;
assuming that OTP staff spend approximately 180 hours preparing for the
site visit at an average cost of $85.42 per hour and an average of 1.33
site visits per facility, the total cost would be $20,450 or an
annualized cost of $15,376 per facility. For the current approximately
2,000 affected OTPs these total annual costs are estimated to be
$30,752,000. The percentage of this total cost that is associated with
record keeping and reporting-only is difficult to estimate, but it is
considered to be a small fraction of the total associated with
accreditation.
i. Estimate of Annualized Cost to the Government
The total annualized cost to SAMHSA for administering 42 CFR part 8
is estimated at $450,000. This estimate includes the cost of an outside
contractor to develop and maintain an extensive on-line protected
website for day-to-day regulatory activities that can be used by
SAMSHA, opioid treatment programs, State Opioid Treatment Authorities,
Accreditation Bodies and other stakeholders. This estimate does not
include funds that SAMHSA/Center for Substance Abuse Treatment (CSAT)
allocates to its ``look back'' program that monitors the adequacy of
accreditation surveys. Of this amount, the total annualized cost to
SAMHSA for Paperwork Reduction Act activities as a result of this
regulation is estimated as $221,434, as shown in the following table.
Annualized Cost to SAMHSA/CSAT
----------------------------------------------------------------------------------------------------------------
Total cost@
Item (purpose) Responses Hours per Total hours $85.42 per
response hour
----------------------------------------------------------------------------------------------------------------
SMA-162 (New Programs).......................... 42 1.5 63 $5,381
SMA-162 (Renewal)............................... 386 .75 289.5 24,729
SMA-162 (Relocation)............................ 35 .25 8.75 747
Notification of Provisional Certification....... 40 .50 20 1,708
Notification of Extension of Provisional 15 .50 7.5 641
Certification..................................
Notification of Sponsor or Medical Director 60 0.33 19.8 1,691
Change.........................................
Documentation to SAMHSA for Interim Treatment... 1 0.50 0.5 43
Requests to SAMHSA for Exemption from Sec. Sec. 24,000 0.07 1680 143,506
8.11 and 8.12 (including SMA-168)............
Notification to SAMHSA Before Establishing 20 1.00 20 1,708
Medication Units...............................
Review of Submissions under Part C.............. 2 2.00 4 342
Accreditation Body Initial Application (SMA-163) 3 40 120 10,250
Accreditation Body Renewal (SMA-163)............ 3 40 120 10,250
Relinquishment Notification..................... 1 .50 0.5 43
Notification for Serious Non-Compliant Programs. 2 .50 1 85
General Documents to SAMHSA Upon Request........ 10 1.00 10 854
Accreditation Survey to SAMHSA Upon Request..... 383 .50 191.5 16,358
Less Than Full Accreditation Report to SAMHSA... 10 1.00 10 854
Summaries of Inspections........................ 12 1.00 12 1,025
Notification of Complaints to SAMHSA............ 10 1.00 10 854
Submission of 90-Day Corrective Plan to SAMHSA.. 1 4.25 4.25 363
---------------------------------------------------------------
Sub total................................... 25,03625,036 97.15 2592.3 221,434
----------------------------------------------------------------------------------------------------------------
2. Consideration of Regulatory Alternatives
The Department has completed rulemaking to make flexibilities
issued during the COVID-19 PHE permanent, while also updating
accreditation and treatment standards to reflect evidence-based
practices and current medical terminology and approaches to OUD
treatment given the current overdose crisis. The alternative would be
to allow the current flexibilities to lapse with the end of the COVID-
19 PHE, or to renew them periodically as may be needed during future
emergencies or changed circumstances. This is considered to be
suboptimal as it creates uncertainty among patients and OTPs, while
also constraining access to care. Rulemaking, on the other hand, allows
OTPs and their patients to operate in a stable and regulated
environment that promotes access to evidence-based interventions. Other
changes in the rule impact Accreditation Body oversight and procedures.
Such changes can only be effectuated in a regulatory setting.
B. Regulatory Flexibility Act
The Department has examined the economic implications of this final
rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612).
If a rule has a significant economic impact on a substantial number of
small entities, the Regulatory Flexibility Act (RFA) requires agencies
to analyze regulatory options that would lessen the economic effect of
the rule on small entities. For purposes of the RFA, small entities
include small businesses, nonprofit organizations, and small
governmental jurisdictions. The Act defines ``small entities'' as (1) a
proprietary firm meeting the size standards of the Small Business
Administration (SBA), (2) a nonprofit organization that is not dominant
in its field, and (3) a small government jurisdiction of less than
50,000 population. Because 90 percent or more of all health care
providers meet the SBA size standard for a small business or are
nonprofit organizations, the Department generally treats all health
care providers as small entities for purposes of performing a
regulatory flexibility analysis. The SBA size standard for health care
providers ranges between a maximum of $8 million and $41.5 million in
annual receipts, depending upon the type of entity.
Pursuant to the RFA (5 U.S.C. 601-612), the Department asserts a
factual basis for its certification that the rule will not have a
significant economic impact on a substantial number of small entities.
As discussed in the Regulatory
[[Page 7548]]
Impact Analysis (RIA) the costs associated with compliance are minimal.
As such, the Department certifies that the proposed rule will not
impose a significant economic impact. The RIA contains the factual
details supporting this certification, affirming the conclusion that
the financial impact of compliance is insubstantial in relation to the
affected entities' financial operations.
C. Unfunded Mandates Reform Act
Section 202(a) of The Unfunded Mandates Reform Act of 1995 (UMRA)
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending that may result in
expenditures in any one year of $100 million in 1995 dollars, updated
annually for inflation. As of 2023, this threshold is $165 million. The
Department does not anticipate that this final rule would result in the
expenditure by State, local, and Tribal governments, taken together, or
by the private sector, of $165 million or more in any one year.
D. Executive Order 13132--Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a final rule that imposes
substantial direct requirement costs on State and local governments,
preempts State law, or otherwise has federalism implications. The
Department does not believe that this rulemaking would have any
significant federalism implications, impose significant costs on State
or local governments or preempt State law.
E. Assessment of Federal Regulation and Policies on Families
Section 654 of the Treasury and General Government Appropriations
Act of 1999 \103\ requires Federal departments and agencies to
determine whether a policy or regulation could affect family well-
being. If the determination is affirmative, then the Department or
agency must prepare an impact assessment to address criteria specified
in the law. The Department believes that the final regulations would
positively impact the ability of patients and families to access
treatment for OUD. The Department does not anticipate negative impacts
on family well-being as a result of this rule.
---------------------------------------------------------------------------
\103\ Public Law 105-277, 112 Stat. 2681 (October 21, 1998).
---------------------------------------------------------------------------
F. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (Pub. L. 104-13),
agencies are required to submit to the Office of Management and Budget
(OMB) for review and approval any reporting or recordkeeping
requirements inherent in a proposed or final rule, and are required to
publish such requirements for public comment. The PRA requires agencies
to provide a 60-day notice in the Federal Register and solicit public
comment on a proposed collection of information before it is submitted
to OMB for review and approval. To fairly evaluate whether an
information collection should be approved by OMB, section 3506(c)(2)(A)
of the PRA requires that the Department solicit comment on the
following issues:
1. Whether the information collection is necessary and useful to
carry out the proper functions of the agency;
2. The accuracy of the agency's estimate of the information
collection burden;
3. The quality, utility, and clarity of the information to be
collected; and
4. Recommendations to minimize the information collection burden on
the affected public, including automated collection techniques.
The PRA requires consideration of the time, effort, and financial
resources necessary to meet the information collection requirements
referenced in this section. The Department explicitly sought public
comment on its assumptions as they relate to the PRA requirements
summarized in this section. No applicable comments were received.
As discussed below, the Department estimates a total OTP burden
associated with all information collections of 1,868.95 hours, and a
total number of burden hours for Accreditation Body respondents of
approximately 394.70 hours each year. The annual burden associated with
this rule and the associated forms is therefore estimated to be
2,263.65 hours.
1. Explanation of Estimated Annualized Burden Hours for 42 CFR Part 8
The Department presents, in separate tables below, burden estimates
for the annual reporting requirement for Accreditation Bodies and OTPs
pursuant to the final rule.
Estimated Annual Reporting Requirement Burden for Accreditation Bodies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Total Hours/
42 CFR citation Purpose respondents respondent responses response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3(b)(1) through (11).................... Initial approval (SMA-163).. 1 1 1 6.0 6
8.3(c).................................... Renewal of approval (SMA- 2 1 2 1.0 2
163).
8.3(e).................................... Relinquishment notification. 1 1 1 0.5 0.5
8.3(f)(2)................................. Non-renewal notification to 1 90 90 0.1 9
accredited OTPs.
8.4(b)(1)(ii)............................. Notification to SAMHSA for 2 2 4 1.0 4
seriously noncompliant OTPs.
8.4(b)(1)(iii)............................ Notification to OTP for 2 10 20 1.0 20
serious noncompliance.
8.4(d)(1)................................. General documents and 6 5 30 0.5 15
information to SAMHSA upon
request.
8.4(d)(2)................................. Accreditation survey to 6 75 450 0.02 9
SAMHSA upon request.
8.4(d)(3)................................. List of surveys, surveyors 6 6 36 0.2 7.2
to SAMHSA upon request.
8.4(d)(4)................................. Report of less than full 6 5 30 0.5 15
accreditation to SAMHSA.
8.4(d)(5)................................. Summaries of Inspections.... 6 50 300 0.5 150
8.4(e).................................... Notifications of Complaints. 12 6 72 0.5 36
[[Page 7549]]
8.6(a)(2) and (b)(3)...................... Revocation notification to 1 185 185 0.3 55.5
Accredited OTPs.
8.6(b).................................... Submission of 90-day 1 1 1 10 10.0
corrective plan to SAMHSA.
8.6(b)(1)................................. Notification to accredited 1 185 185 0.3 55.5
OTPs of Probationary Status.
-------------------------------------------------------------------------------------------------------------
Sub total............................. ............................ 54 .............. 1,407 .............. 394.70
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Total Hours/
42 CFR citation Purpose respondents respondent responses response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.11(b)................................... Renewal of approval (SMA- 386 1 386 0.15 57.9
162).
8.11(b)................................... Relocation of Program (SMA- 35 1 35 1.17 40.95
162).
8.11(d)................................... Application for provisional 42 1 42 1 42.00
certification.
8.11(f)................................... Application for extension of 30 1 30 0.25 7.50
provisional certification.
8.11(g)(5)................................ Notification of sponsor or 60 1 60 0.1 6.00
medical director change
(SMA-162).
8.11(h)(2)................................ Documentation to SAMHSA for 1 1 1 1 1.00
interim treatment.
8.11(i)................................... Request to SAMHSA for 1,200 20 24,000 0.07 1,680
Exemption from Sec. Sec.
8.11 and 8.12 (including
SMA-168).
8.11(j)(1)................................ Notification to SAMHSA 10 1 10 0.25 2.5
Before Establishing
Medication Units (SMA-162).
8.12(j)(2)................................ Notification to State Opioid 1 20 20 0.33 6.6
Treatment Authority For
Interim Treatment.
8.24...................................... Contents of Appellant 2 1 2 0.25 .50
Request for Review of
Suspension.
8.25(a)................................... Informal Review Request..... 2 1 2 1.00 2.00
8.26(a)................................... Appellant's Review File and 2 1 2 5.00 10.00
Written Statement.
8.28(a)................................... Appellant's Request for 2 1 2 1.00 2.00
Expedited Review.
8.28(c)................................... Appellant Review File and 2 1 2 5.00 10.00
Written Statement.
-------------------------------------------------------------------------------
Sub total............................. ............................ 1,775 .............. 24,594 .............. 1,868.95
-------------------------------------------------------------------------------
Total............................. ............................ 1,829 .............. 26,001 .............. 2,263.65
--------------------------------------------------------------------------------------------------------------------------------------------------------
The tables above reflect current estimates of burden, as the final
rule does not effectively add or alter new reporting requirements. The
estimates are derived from SAMHSA's data and are reflective of work
from over the preceding eighteen months. Further to this, the estimates
of burden do not substantially differ from previously submitted
estimates provided to The Office of Management and Budget. Recognizing
the importance of expanding access to care, the Department has been
careful to limit additional burden.
The final rule does not alter reporting requirements as these have
been shown to be effective in the safe administration of OTPs. The
accreditation system provides effective oversight, while OTP reporting
requirements support accreditation activities and the provision of safe
treatment. Further to this, the final rule retains requirements that
OTP's and accreditation organizations disclose information related to
patient care and clinic policies and procedures for the treatment of
OUD with MOUD. For example, Sec. 8.12(e)(1) requires that a health
care practitioner explain the facts concerning the use of MOUD to each
patient. This type of disclosure is considered to be consistent with
common medical practice and is not considered an additional burden.
Further, the requirement under Sec. 8.4(i)(1) that each accreditation
organization shall make public its fee structure is considered standard
business practice and is not considered a burden in this analysis.
List of Subjects in 42 CFR Part 8
Administrative practice and procedure, Health professions,
Methadone, Reporting and recordkeeping requirements, Substance misuse.
0
For the reasons stated in the preamble, the Department of Health and
Human
[[Page 7550]]
Services revises 42 CFR part 8 to read as set forth below:
PART 8--MEDICATIONS FOR THE TREATMENT OF OPIOID USE DISORDER
Subpart A--General Provisions
Sec.
8.1 Scope.
8.2 Definitions.
Subpart B--Accreditation of Opioid Treatment Programs
8.3 Application for approval as an Accreditation Body.
8.4 Accreditation Body responsibilities.
8.5 Periodic evaluation of Accreditation Bodies.
8.6 Withdrawal of approval of Accreditation Bodies.
Subpart C--Certification and Treatment Standards for Opioid Treatment
Programs
8.11 Opioid Treatment Program certification.
8.12 Federal Opioid Use Disorder treatment standards.
8.13 Revocation of accreditation and Accreditation Body approval.
8.14 Suspension or revocation of certification.
8.15 Forms.
Subpart D--Procedures for Review of Suspension or Proposed Revocation
of OTP Certification, and of Adverse Action Regarding Withdrawal of
Approval of an Accreditation Body
8.21 Applicability.
8.22 Definitions.
8.23 Limitation on issues subject to review.
8.24 Specifying who represents the parties.
8.25 Informal review and the reviewing official's response.
8.26 Preparation of the review file and written arguments.
8.27 Opportunity for oral presentation.
8.28 Expedited procedures for review of immediate suspension.
8.29 Ex parte communications.
8.30 Transmission of written communications by reviewing official
and calculation of deadlines.
8.31 Authority and responsibilities of the reviewing official.
8.32 Administrative record.
8.33 Written decision.
8.34 Court review of final administrative action; exhaustion of
administrative remedies.
Subpart E [Reserved]
Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2,
300x-23, 300x-27(a), 300y-11.
Subpart A--General Provisions
Sec. 8.1 Scope.
(a) Scope. This subpart and subparts B through D of this part
establish the procedures by which the Secretary of Health and Human
Services (the Secretary) will determine whether an applicant seeking to
become an Opioid Treatment Program (OTP) is qualified under section
303(h) of the Controlled Substances Act (CSA) (21 U.S.C. 823(h)) to
dispense Medications for Opioid Use Disorder (MOUD) in the treatment of
Opioid Use Disorder (OUD), and establishes the Secretary's standards
regarding the appropriate quantities of MOUD that may be provided for
unsupervised use by individuals undergoing such treatment (21 U.S.C.
823(h)). Under this subpart and subparts B through D, an applicant
seeking to become an OTP must first obtain from the Secretary or, by
delegation, from the Assistant Secretary for Mental Health and
Substance Use, a certification that the applicant is qualified under
the Secretary's standards and will comply with such standards.
Eligibility for certification will depend upon the applicant obtaining
accreditation from an Accreditation Body that has been approved by the
Secretary. This subpart and subparts B through D also establish the
procedures whereby an entity can apply to become an approved
Accreditation Body, and the requirements and general standards for
Accreditation Bodies to ensure that OTPs are consistently evaluated for
compliance with the Secretary's standards for treatment of OUD with
MOUD.
(b) Severability. Any provision of this part held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, or stayed pending further agency action, shall be
construed so as to give it the maximum effect permitted by law, unless
such holding shall be one of utter invalidity or unenforceability, in
which event such provision shall be severable from this part and shall
not affect the remainder thereof or the application of the provision to
persons not similarly situated or to dissimilar circumstances.
Sec. thnsp;8.2 Definitions.
The following definitions apply to this part:
Accreditation Body or ``the Body'' means an organization that has
been approved by the Secretary in this part to accredit OTPs dispensing
MOUD.
Accreditation Body application means the application filed with the
Secretary for purposes of obtaining approval as an Accreditation Body,
as described in Sec. 8.3(b).
Accreditation elements mean the elements or standards that are
developed and adopted by an Accreditation Body and approved by the
Secretary.
Accreditation survey means an onsite or virtual review and
evaluation of an OTP by an Accreditation Body for the purpose of
determining compliance with the Federal opioid use disorder treatment
standards described in Sec. 8.12.
Accredited OTP means an OTP that is the subject of a current, valid
accreditation from an Accreditation Body approved by the Secretary
under Sec. 8.3(d).
Behavioral health services means any intervention carried out in a
therapeutic context at an individual, family, or group level.
Interventions may include structured, professionally administered
clinical interventions (e.g., cognitive behavior therapy or insight-
oriented psychotherapy) delivered in-person, or remotely via telehealth
or telemedicine, which has been shown to facilitate treatment outcomes,
or non-clinical interventions.
Care plan means an individualized treatment and/or recovery plan
that outlines attainable treatment goals that have been identified and
agreed upon between the patient and the OTP clinical team, and which
specifies the services to be provided, as well as the proposed
frequency and schedule for their provision.
Certification means the process by which the Secretary determines
that an OTP is qualified to provide OUD treatment under the Federal
Opioid Use Disorder treatment standards.
Certification application means the application filed by an OTP for
purposes of obtaining certification from the Secretary, as described in
Sec. 8.11(b).
Certified opioid treatment program means an OTP that is the subject
of a current, valid certification under Sec. 8.11.
Comprehensive treatment is treatment that includes the continued
use of MOUD provided in conjunction with an individualized range of
appropriate harm reduction, medical, behavioral health, and recovery
support services.
Conditional certification is a type of temporary certification
granted to an OTP that has requested renewal of its certification and
that has received temporary accreditation for one year by an approved
Accreditation Body. The one-year accreditation period is to allow the
OTP to address areas of significant non-conformance with accreditation
standards that do not involve immediate, high-risk health and/or safety
concerns.
Continuous medication treatment means the uninterrupted treatment
for OUD involving the dispensing and administration of MOUD at stable
dosage levels for a period in excess of 21 days.
Dispense means to deliver a controlled medication to an ultimate
user by, or pursuant to, the lawful order
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of, a practitioner, including the prescribing and administering of a
controlled medication.
Diversion control plan means a set of documented procedures that
reduce the possibility that controlled medications will be transferred
or otherwise shared with others to whom the medication was not
prescribed or dispensed.
Federal Opioid Use Disorder treatment standards means the standards
established by the Secretary in Sec. 8.12 that are used to determine
whether an OTP is qualified to engage in OUD treatment. The Federal
Opioid Use Disorder treatment standards established in Sec. 8.12 also
include the standards established by the Secretary regarding the
quantities of MOUD which may be provided for unsupervised, take-home
use.
For-cause inspection means an inspection, by the Secretary, an
Accreditation Body, or a State authority, of an OTP that may be
operating in violation of Federal Opioid Use Disorder treatment
standards, may be providing substandard treatment, may be serving as a
possible source of diverted medications, or where patient well-being is
at risk.
Harm reduction refers to practical and legal evidence-based
strategies, including: overdose education; testing and intervention for
infectious diseases, including counseling and risk mitigation
activities forming part of a comprehensive, integrated approach to
address human immunodeficiency virus (HIV), viral hepatitis, sexually
transmitted infections, and bacterial and fungal infections;
distribution of opioid overdose reversal medications; linkage to other
public health services; and connecting those who have expressed
interest in additional support to peer services.
Individualized dose means the dose of a medication for opioid use
disorder, ordered by an OTP practitioner and dispensed to a patient,
that sufficiently suppresses opioid withdrawal symptoms. Individualized
doses may also include split doses of a medication for opioid use
disorder, where such dosing regimens are indicated.
Interim treatment means that on a temporary basis, a patient may
receive some services from an OTP, while awaiting access to more
comprehensive treatment services. The duration of interim treatment is
limited to 180 days.
Long-term care facilities mean those facilities that provide
rehabilitative, restorative, and/or ongoing services to those in need
of assistance with activities of daily living. Long-term care
facilities include: extended acute care facilities; rehabilitation
centers; skilled nursing facilities; permanent supportive housing;
assisted living facilities; and chronic care hospitals.
Medical director means a physician, licensed to practice medicine
in the jurisdiction in which the OTP is located, who assumes
responsibility for all medical and behavioral health services provided
by the program, including their administration. A medical director may
delegate specific responsibilities to authorized program physicians,
appropriately licensed non-physician practitioners with prescriptive
authority functioning under the medical director's supervision, or
appropriately licensed and/or credentialed non-physician healthcare
professionals providing services in the OTP, in compliance with
applicable Federal and State laws. Such delegations will not eliminate
the medical director's responsibility for all medical and behavioral
health services provided by the OTP.
Medication for Opioid Use Disorder or MOUD means medications,
including opioid agonist medications, approved by the Food and Drug
Administration under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355), for use in the treatment of OUD. As used
in this part, ``continuous medication treatment'' is intended to be
synonymous with the term ``maintenance'' treatment as used in 21 U.S.C.
823(h)(1), and the term ``withdrawal management'' is intended to be
synonymous with the term ``detoxification'' as used in 21 U.S.C.
823(h)(1).
Medication unit means an entity that is established as part of, but
geographically separate from, an OTP from which appropriately licensed
OTP practitioners, contractors working on behalf of the OTP, or
community pharmacists may dispense or administer MOUD, collect samples
for drug testing or analysis, or provide other OTP services. Medication
units can be a brick-and-mortar location or mobile unit.
Nationally recognized evidence-based guidelines mean a document
produced by a national or international medical professional
association, public health agency, such as the World Health
Organization, or governmental body with the aim of assuring the
appropriate use of evidence to guide individual diagnostic and
therapeutic clinical decisions for the management of OUD and other
health conditions that are widely recognized within the United States.
Opioid Treatment Program or OTP means a program engaged in OUD
treatment of individuals with MOUD registered under 21 U.S.C.
823(h)(1).
Opioid Treatment Program certification means the process by which
the Secretary determines that an OTP applicant is qualified to provide
Opioid Use Disorder treatment under the Federal Opioid Use Disorder
treatment standards described in Sec. 8.12.
Opioid Use Disorder means a cluster of cognitive, behavioral, and
physiological symptoms associated with a problematic pattern of opioid
use that continues despite clinically significant impairment or
distress within a 12-month period.
Opioid Use Disorder treatment means the dispensing of MOUD, along
with the provision of a range of medical and behavioral health
services, as clinically necessary and based on an individualized
assessment and a mutually agreed-upon care plan, to an individual to
alleviate the combination of adverse medical, psychological, or
physical effects associated with an OUD.
Patient, for purposes of this part, means any individual who
receives continuous treatment or withdrawal management in an OTP.
Physical and behavioral health services include services such as
medical and psychiatric screening, assessments, evaluations,
examinations, and interventions, counseling, health education, peer
support services, and social services (e.g., vocational and educational
guidance, employment training), that are intended to help patients
receiving care in OTPs achieve and sustain remission and recovery.
Practitioner, for purposes of this part, means a health care
professional who is appropriately licensed by a State to prescribe and/
or dispense medications for opioid use disorders and, as a result, is
authorized to practice within an OTP.
Program sponsor means the person named in the application for
certification described in Sec. 8.11(b) as responsible for the
operation of the OTP and who assumes responsibility for all its
employees, including any practitioners, agents, or other persons
providing medical, behavioral health, or social services at the program
or any of its medication units. The program sponsor need not be a
licensed physician but shall ensure that an actively licensed physician
occupies the position of medical director within an OTP.
Recovery support services means:
(1) Recovery is the process of change through which people improve
their health and wellness, live self-directed lives, and strive to
reach their full potential.
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(2) Recovery support services can include, but are not limited to,
community-based recovery housing, peer recovery support services,
social support, linkage to and coordination among allied service
providers and a full range of human services that facilitate recovery
and wellness contributing to an improved quality of life. The services
extend the continuum of care by strengthening and complementing
substance use disorder (SUD) treatment interventions in different
settings and stages.
Split dosing means dispensing of a single dose of MOUD as separate
portions to be taken within a 24-hour period. Split dosing is indicated
among, but not limited to, those patients who: possess a genetic
variant which increases methadone metabolism; concurrently take other
medications or drink alcohol that also induce hepatic enzymes leading
to more rapid metabolism of methadone; who are pregnant; or for whom
methadone or buprenorphine are being used to treat a concurrent pain
indication in addition to the diagnosis of OUD. This leads to more
stable, steady-state medication levels.
State Opioid Treatment Authority (SOTA) is the agency designated by
the Governor of a State, or other appropriate official designated by
the Governor, to exercise the responsibility and authority within the
State or Territory for governing the treatment of OUD with MOUD in
OTPs.
Telehealth or telemedicine, for purposes of this part, is the
delivery and facilitation of health and health-related services
including medical care, counseling, practitioner, provider and patient
education, health information services, and self-care via
telecommunications and digital communication technologies. This
includes Health Insurance Portability and Accountability Act (HIPAA)-
compliant video and audio-only communication platforms.
Withdrawal management means the dispensing of a MOUD in decreasing
doses to an individual to alleviate adverse physical effects incident
to withdrawal from the continuous or sustained use of an opioid and as
a method of bringing the individual to an opioid-free state within such
period. Long-term withdrawal management refers to the process of
medication tapering that exceeds 30 days.
Subpart B--Accreditation of Opioid Treatment Programs
Sec. 8.3 Application for approval as an Accreditation Body.
(a) Eligibility. Private nonprofit organizations, State or
territorial governmental entities, or political subdivisions thereof,
and Indian Tribes as defined by the Federally Recognized Indian Tribe
List Act of 1994, that are capable of meeting the requirements of this
part may apply for approval as an Accreditation Body.
(b) Application for initial approval. Electronic copies of an
Accreditation Body application form [SMA-167] shall be submitted to:
https://dpt2.samhsa.gov/sma163/. Accreditation Body applications shall
include the following information and supporting documentation:
(1) Name, address, and telephone number of the applicant and a
responsible official for the Accreditation Body. The application shall
be signed by the responsible official;
(2) Evidence of the nonprofit status of the applicant (i.e., of
fulfilling Internal Revenue Service requirements as a nonprofit
organization) if the applicant is not a State or territorial
governmental entity, Indian Tribe, or political subdivision;
(3) A set of the accreditation elements or standards and a detailed
discussion showing how the proposed accreditation elements or standards
will ensure that each OTP surveyed by the applicant is qualified to
meet or is meeting each of the Federal opioid use disorder treatment
standards set forth in Sec. 8.12;
(4) A detailed description of the applicant's decision-making
process, including:
(i) Procedures for initiating and performing onsite accreditation
surveys of OTPs;
(ii) Procedures for assessing OTP personnel qualifications;
(iii) Copies of an application for accreditation, guidelines,
instructions, and other materials the applicant will send to OTPs
during the accreditation process, including a request for a complete
history of prior accreditation activities and a statement that all
information and data submitted in the application for accreditation is
true and accurate, and that no material fact has been omitted;
(iv) Policies and procedures for notifying OTPs and the Secretary
of deficiencies, for monitoring corrections of deficiencies by OTPs and
for reporting corrections to the Secretary;
(v) Policies and procedures for determining OTPs level of adherence
to this part and Accrediting Body standards and level of accreditation;
(vi) Policies and procedures for suspending or revoking an OTP's
accreditation;
(vii) Policies and procedures that will ensure processing of
applications for accreditation and applications for renewal of
accreditation within a timeframe approved by the Secretary; and
(viii) A description of the applicant's appeals process to allow
OTPs to contest adverse accreditation decisions;
(5) Policies and procedures established by the Accreditation Body
to avoid conflicts of interest, or the appearance of conflicts of
interest, by the applicant's board members, commissioners, professional
personnel, consultants, administrative personnel, and other
representatives;
(6) A description of the education, experience, and training
requirements for the applicant's professional staff, accreditation
survey team membership, and the identification of at least one licensed
physician with experience treating OUD with MOUD on the applicant's
staff;
(7) A description of the applicant's survey team training policies;
(8) Fee schedules, with supporting cost data;
(9) Satisfactory assurances that the Body will comply with the
requirements of Sec. 8.4, including a contingency plan for
investigating complaints under Sec. 8.4(e);
(10) Policies and procedures established to protect confidential
information the applicant will collect or receive in its role as an
Accreditation Body; and
(11) Any other supporting information the Secretary may require.
(c) Application for renewal of approval. An Accreditation Body that
intends to continue to serve as an Accreditation Body beyond its
current term shall apply to the Secretary for renewal, or notify the
Secretary of its intention not to apply for renewal, in accordance with
the following procedures and schedule:
(1) At least 9 months before the date of expiration of an
Accreditation Body's term of approval, the Body shall inform the
Secretary in writing of its intent to seek renewal.
(2) The Secretary will notify the applicant of the relevant
information, materials, and supporting documentation required under
paragraph (b) of this section that the applicant shall submit as part
of the renewal procedure.
(3) At least 3 months before the date of expiration of the
Accreditation
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Body's term of approval, the applicant shall send to the Secretary
electronically a renewal application containing the information,
materials, and supporting documentation requested by the Secretary
under paragraph (c)(2) of this section.
(4) An Accreditation Body that does not intend to renew its
approval shall so notify the Secretary at least 9 months before the
expiration of the Body's term of approval.
(d) Rulings on applications for initial approval or renewal of
approval. (1) The Secretary will grant an application for initial
approval or an application for renewal of approval if it determines the
applicant substantially meets the Accreditation Body requirements of
this subpart.
(2) If the Secretary determines that the applicant does not
substantially meet the requirements set forth in this subpart, the
Secretary will notify the applicant of the deficiencies in the
application and request that the applicant resolve such deficiencies
within 90 days of receipt of the notice. If the deficiencies are
resolved to the satisfaction of the Secretary within the 90-day time
period, the Body will be approved as an Accreditation Body. If the
deficiencies have not been resolved to the satisfaction of the
Secretary within the 90-day time period, the application for approval
as an Accreditation Body will be denied.
(3) If the Secretary does not reach a final decision on a renewal
application before the expiration of an Accreditation Body's term of
approval, the approval will be deemed extended until the Secretary
reaches a final decision, unless an Accreditation Body does not rectify
deficiencies in the application within the specified time period, as
required in paragraph (d)(2) of this section.
(e) Relinquishment of approval. An Accreditation Body that intends
to relinquish its accreditation approval before expiration of the
Body's term of approval shall submit a letter of such intent to the
Secretary, at the address in paragraph (b) of this section, at least 9
months before relinquishing such approval.
(f) Notification. An Accreditation Body that does not apply for
renewal of approval, or is denied such approval by the Secretary,
relinquishes its accreditation approval before expiration of its term
of approval, or has its approval withdrawn, shall:
(1) Transfer copies of records and other related information as
required by the Secretary to a location, including another
Accreditation Body, and according to a schedule approved by the
Secretary; and
(2) Notify, in a manner and time period approved by the Secretary,
all OTPs accredited or seeking accreditation by the Body that the Body
will no longer have approval to provide accreditation services.
(g) Term of approval. An Accreditation Body's term of approval is
for a period not to exceed 5 years.
(h) State, territorial, or Indian Tribe Accreditation Bodies.
State, territorial, and Indian Tribe entities, including political
subdivisions thereof, may establish organizational units that may act
as Accreditation Bodies, provided such units meet the requirements of
this section, are approved by the Secretary under this section, and
have taken appropriate measures to prevent actual or apparent conflicts
of interest, including cases in which State or Federal funds are used
to support MOUD.
Sec. 8.4 Accreditation Body responsibilities.
(a) Accreditation surveys and for cause inspections. (1)
Accreditation Bodies shall conduct routine accreditation surveys for
initial accreditation, and then at least every three years to allow for
renewal of certification.
(2) Accreditation Bodies must agree to conduct for-cause
inspections upon the request of the Secretary.
(3) Accreditation decisions shall be fully consistent with the
policies and procedures submitted as part of the approved Accreditation
Body application.
(b) Response to noncompliant programs. (1) If an Accreditation Body
receives or discovers information that suggests that an OTP is not
meeting applicable accreditation or certification standards established
or authorized under this part, or if a survey of the OTP by the
Accreditation Body demonstrates that such standards are not being met,
the Accreditation Body shall, within 60 days following discovery of the
non-compliant condition(s) or applicable survey date:
(i) Provide written notice to the OTP that identifies each area of
non-compliance, categorizes each non-compliant condition as either
``minor'' or ``significant'' as determined by the Accrediting Body, and
requires the OTP to take corrective action to address the area(s) of
non-compliance within a schedule, not to exceed 180 days, that the
Accrediting Body deems appropriate based on the severity of the non-
compliant conditions; and
(ii) Provide the Secretary with a copy of the written notice
required under paragraph (b)(1)(i) of this section.
(2) Once an Accreditation Body provides an OTP with the notice
described in paragraph (b)(1)(i) of this section, it shall verify the
implementation of the corrective measures by the OTP within the
specified schedule. Within 30 days following the last day of the
specified schedule, the Accreditation Body shall provide written notice
to the Secretary regarding whether the OTP has implemented the
corrective measures.
(3) OTPs that are meeting the requirements of Sec. 8.12, but are
only required to correct minor non-compliant conditions shall be
granted a three-year accreditation, beginning from the end date of the
current and expiring accreditation period. Minor non-compliant
conditions, found at the time of the survey that are not resolved, as
determined by the Accreditation Body, within the OTP's three-year
accreditation period and that remain areas of non-compliance during the
OTP's subsequent three-year accreditation renewal survey, shall
automatically be categorized as ``significant'' non-compliant
conditions for purposes of the renewal survey and must be corrected in
accordance with paragraph (b)(1)(i) of this section.
(4) OTPs that are required to correct significant non-compliant
conditions shall be granted a one-year accreditation, beginning from
the end date of the current and expiring accreditation period. An OTP's
accreditation must be revoked if it fails to correct significant non-
compliant conditions within the schedule provided under paragraph
(b)(1)(i) of this section. If an Accrediting Body verifies that an OTP
has corrected the significant non-compliant conditions identified
within the specified schedule, it shall extend the OTP's accreditation
period by an additional two years.
(5) In cases of severe non-compliance with the requirements of
Sec. 8.12 that pose immediate risks to patient health and safety, the
Accreditation Body shall inform the OTP and Secretary within 48 hours
and provide a detailed written report of the non-compliance within 5
business days. The Accreditation Body shall give the OTP 30 days from
the date of the non-compliance report to correct the non-compliance
issue(s). A follow-up survey shall be conducted by the Accreditation
Body within 30 days of the expected correction date to ensure
successful remediation. Should the OTP not rectify the non-compliance
within the 30-day period, the Accreditation Body shall revoke the OTP's
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accreditation. The Secretary will then make a decision regarding the
OTP's certification in accordance with the procedures under Sec. 8.13.
(c) Recordkeeping. (1) Accreditation Bodies shall maintain, and
make available as requested by the Secretary, records of their
accreditation activities for at least 5 years from the creation of the
record. Such records must contain sufficient detail to support each
accreditation decision made by the Accreditation Body.
(2) Accreditation Bodies shall establish procedures to protect
confidential information collected or received in their role as
Accreditation Bodies that are consistent with, and that are designed to
ensure compliance with, all Federal and State laws, including 42 CFR
part 2.
(i) Information collected or received for the purpose of carrying
out Accreditation Body responsibilities shall not be used for any other
purpose or disclosed, other than to the Secretary or its duly
designated representatives, unless otherwise required by law or with
the consent of the OTP.
(ii) Nonpublic information that the Secretary shares with the
Accreditation Body concerning an OTP shall not be further disclosed
except with the written permission of the Secretary.
(d) Reporting. (1) Accreditation Bodies shall provide to the
Secretary any documents and information requested by the Secretary
within 5 days of receipt of the request.
(2) Accreditation Bodies shall submit a summary of the results of
each accreditation survey to the Secretary within 90 days following the
survey visit. Such summaries shall contain sufficient detail to justify
the accreditation action taken.
(3) Accreditation Bodies shall provide the Secretary a list of each
OTP surveyed, and the identity of all individuals involved in the
conducting and reporting of survey results.
(4) Accreditation Bodies shall submit to the Secretary the name of
each OTP for which the Accreditation Body accredits conditionally,
denies, suspends, or revokes accreditation, and the basis for the
action, within 48 hours of the action.
(5) Notwithstanding any reports made to the Secretary under
paragraphs (d)(1) through (4) of this section, each Accreditation Body
shall submit to the Secretary semiannually, on January 15 and July 15
of each calendar year, a report consisting of a summary of the results
of each accreditation survey conducted in the past year. The summary
shall contain sufficient detail to justify each accreditation action
taken.
(6) All reporting requirements listed in this section shall be
provided to the Secretary at the address specified in Sec. 8.3(b).
(e) Complaint response. Accreditation Bodies shall have policies
and procedures in place to respond to complaints received from the
Secretary, patients, facility staff, and others within 5 business days
from the receipt of the complaint. Accreditation Bodies shall also
agree to notify the Secretary within 5 business days of receipt of a
complaint from a patient, facility, staff or others, and to inform the
Secretary of their response to the complaint.
(f) Modifications of accreditation elements. Accreditation Bodies
shall obtain the Secretary's written authorization prior to making any
substantive (i.e., noneditorial) change in accreditation elements.
(g) Conflicts of interest. The Accreditation Body shall maintain
and apply policies and procedures that the Secretary has approved in
accordance with Sec. 8.3 to reduce the possibility of actual conflict
of interest, or the appearance of a conflict of interest, on the part
of individuals who act on behalf of the Accreditation Body. Individuals
who participate in accreditation surveys or otherwise participate in
the accreditation decision or an appeal of the accreditation decision,
as well as their spouses and minor children, shall not have a financial
interest in the OTP that is the subject of the accreditation survey or
decision.
(h) Accreditation teams. (1) An Accreditation Body survey team
shall consist of healthcare professionals with expertise in OUD
treatment. The Accreditation Body shall consider factors such as the
size of the OTP, the anticipated number of survey non-compliance
issues, and the OTP's accreditation history in determining the
composition of the team. At a minimum, survey teams shall consist of at
least two healthcare professionals whose combined expertise includes:
(i) The dispensing and administration of medications subject to
control under the Controlled Substances Act (21 U.S.C. 801 et seq.);
(ii) Medical issues relating to the dosing and administration of
MOUD for the treatment of OUD;
(iii) Psychosocial counseling of individuals receiving OUD
treatment; and
(iv) Organizational and administrative issues associated with OTPs.
(2) Members of the accreditation team must be able to recuse
themselves at any time from any survey in which either they or the OTP
believes there is an actual conflict of interest or the appearance of a
conflict of interest. Conflict or perceived conflict of interest must
be documented by the Accreditation Body and made available to the
Secretary.
(i) Accreditation fees. Fees charged to OTPs for accreditation
shall be reasonable. the Secretary generally will find fees to be
reasonable if the fees are limited to recovering costs to the
Accreditation Body, including overhead incurred. Accreditation Body
activities that are not related to accreditation functions are not
recoverable through fees established for accreditation.
(1) The Accreditation Body shall make public its fee structure,
including those factors, if any, contributing to variations in fees for
different OTPs.
(2) At the Secretary's request, Accreditation Bodies shall provide
to the Secretary financial records or other materials, in a manner
specified by the Secretary, to assist in assessing the reasonableness
of Accreditation Body fees.
Sec. 8.5 Periodic evaluation of Accreditation Bodies.
The Secretary will periodically evaluate the performance of
Accreditation Bodies primarily by inspecting a selected sample of the
OTPs accredited by the Accrediting Body, and by evaluating the
Accreditation Body's reports of surveys conducted, to determine whether
the OTPs surveyed and accredited by the Accreditation Body are in
compliance with applicable standards under this part. The evaluation
will include a determination of whether there are major deficiencies in
the Accreditation Body's performance that, if not corrected, would
warrant withdrawal of the approval of the Accreditation Body under
Sec. 8.6.
Sec. 8.6 Withdrawal of approval of Accreditation Bodies.
If the Secretary determines that an Accreditation Body is not in
substantial compliance with this subpart, the Secretary shall take
appropriate action as follows:
(a) Major deficiencies. If the Secretary determines that the
Accreditation Body has a major deficiency, such as commission of fraud,
material false statement, failure to perform a major accreditation
function satisfactorily, or significant noncompliance with the
requirements of this subpart, the Secretary shall withdraw approval of
that Accreditation Body.
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(1) In the event of a major deficiency, the Secretary shall notify
the Accreditation Body of the agency's action and the grounds on which
the approval was withdrawn.
(2) An Accreditation Body that has lost its approval shall notify
each OTP that has been accredited or is seeking accreditation that the
Accreditation Body's approval has been withdrawn. Such notification
shall be made within a time period and in a manner approved by the
Secretary.
(b) Minor deficiencies. If the Secretary determines that the
Accreditation Body has minor deficiencies in the performance of an
accreditation function, that are less serious or more limited than the
types of deficiencies described in paragraph (a) of this section, the
Secretary will notify the Body that it has 90 days to submit to the
Secretary a plan of corrective action. The plan must include a summary
of corrective actions and a schedule for their implementation. The
Secretary may place the Body on probationary status for a period of
time determined by the Secretary, or may withdraw approval of the Body
if corrective action is not taken.
(1) If the Secretary places an Accreditation Body on probationary
status, the Body shall notify all OTPs that have been accredited, or
that are seeking accreditation, of the Accreditation Body's
probationary status within a time period and in a manner approved by
the Secretary.
(2) Probationary status will remain in effect until such time as
the Body can demonstrate to the satisfaction of the Secretary that it
has successfully implemented or is implementing the corrective action
plan within the established schedule, and the corrective actions taken
have substantially eliminated all identified problems.
(3) If the Secretary determines that an Accreditation Body that has
been placed on probationary status is not implementing corrective
actions satisfactorily or within the established schedule, the
Secretary may withdraw approval of the Accreditation Body. The
Accreditation Body shall notify all OTPs that have been accredited, or
are seeking accreditation, of the Accreditation Body's loss of the
Secretary's approval within a time period and in a manner approved by
the Secretary.
(c) Reapplication. (1) An Accreditation Body that has had its
approval withdrawn may submit a new application for approval if the
Body can provide information to the Secretary to establish that the
problems that were grounds for withdrawal of approval have been
resolved.
(2) If the Secretary determines that the new application
demonstrates that the Body satisfactorily has addressed the causes of
its previous unacceptable performance, the Secretary may reinstate
approval of the Accreditation Body.
(3) The Secretary may request additional information or establish
additional conditions that must be met before the Secretary approves
the reapplication.
(4) The Secretary may refuse to accept an application from a former
Accreditation Body whose approval was withdrawn because of fraud,
material false statement, or willful disregard of public health.
(d) Hearings. An opportunity to challenge an adverse action taken
regarding withdrawal of approval of an Accreditation Body shall be
addressed through the relevant procedures set forth in subpart C of
this part, except that the procedures in Sec. 8.28 for expedited
review of an immediate suspension would not apply to an Accreditation
Body that has been notified under paragraph (a) or (b) of this section
of the withdrawal of its approval.
Subpart C--Certification and Treatment Standards for Opioid
Treatment Programs
Sec. 8.11 Opioid Treatment Program certification.
(a) General. (1) An OTP must be the subject of a current, valid
certification from the Secretary to be considered qualified by the
Secretary under section 303(g)(1) of the Controlled Substances Act (21
U.S.C. 823(h)(1)) to dispense MOUD in the treatment of OUD. An OTP must
be determined to be qualified under section 303(g)(1) of the Controlled
Substances Act, and must be determined to be qualified by the Attorney
General under section 303(g)(1), to be registered by the Attorney
General to dispense MOUD to individuals for treatment of OUD.
(2) To obtain certification from the Secretary, an OTP must meet
the Federal Opioid Use Disorder treatment standards in Sec. 8.12, must
be the subject of a current, valid accreditation by an Accreditation
Body or other entity designated by the Secretary and must comply with
any other conditions for certification established by the Secretary.
(3) OTPs are expected to maintain certification with the Secretary
and to comply with any other conditions for certification established
by the Secretary. Certification shall be granted for a term not to
exceed 3 years, except that certification may be renewed during the
final certification year if the OTP applies for certification renewal
in accordance with the steps outlined in paragraph (a)(4) of this
section.
(4) OTPs which satisfy the criteria for certification under this
section may apply for renewal of their certification. OTPs are expected
to apply for certification renewal during the final year of the OTP's
certification period. OTPs should take steps to ensure that
administrative tasks associated with renewal are completed before the
OTP's certification expires. OTPs may apply for certification renewal
in accordance with the procedures as outlined in paragraph (b) of this
section. If an OTP anticipates any delays in routine certification
renewal, an extension may be requested by submitting to the Secretary a
statement justifying the extension in accordance with paragraph (e) of
this section.
(5) OTPs that are certified and are seeking certification renewal,
and who have been granted accreditation for one year by an
Accreditation Body as provided under Sec. 8.4(b)(1)(iii), may receive
a conditional certification for one year unless the Secretary
determines that such conditional certification would adversely affect
patient health. An OTP must obtain a standard 3-year certification, as
described in paragraph (a)(3) of this section, within the 1-year
conditional certification period. If standard accreditation is not
obtained by the OTP within the 1-year conditional certification period,
the OTP's conditional certification will lapse, and the Attorney
General will be notified that the OTP's registration should be revoked.
(6) OTPs whose certification has expired, and who seek re-
certification, will be considered ``new'' programs and will be required
to apply for provisional certification in accordance with paragraph (d)
of this section.
(b) Application for initial or renewal certifications and re-
certification. Applications for certification must be submitted by the
OTP using form SMA-162. The application for initial or renewal of
certification shall include, as determined by the Secretary:
(1) A description of the current accreditation status of the OTP;
(2) A description of the organizational structure of the OTP;
(3) The names of the persons responsible for the OTP;
(4) The addresses of the OTP and of each medication unit or other
facility under the of the OTP;
(5) The sources of funding for the OTP and the name and address of
each
[[Page 7556]]
governmental entity that provides such funding;
(6) A statement that the OTP will comply with the conditions of
certification set forth in paragraph (g) of this section; and
(7) The application shall be signed by the program sponsor who
shall certify that the information submitted in the application is
truthful and accurate.
(8) Applications for re-certification shall include an explanation
of why the OTP's most recent certification expired and information
regarding the schedule for an accreditation survey.
(c) Action on application. (1) Following the Secretary's receipt of
an application for certification of an OTP, and after consultation with
the appropriate State authority regarding the qualifications of the
applicant, the Secretary may grant the application for certification,
or renew an existing certification, if the Secretary determines that
the OTP has satisfied the requirements for certification or renewal of
certification in this section.
(2) The Secretary may deny the application if the Secretary
determines that:
(i) The application for certification is deficient in any respect;
(ii) The OTP will not be operated in accordance with the Federal
Opioid Use Disorder treatment standards established under Sec. 8.12;
(iii) The OTP will not permit an inspection or a survey to proceed,
or will not permit in a timely manner access to relevant records or
information; or
(iv) The OTP has made misrepresentations in obtaining accreditation
or in applying for certification.
(3) Within 5 days after it reaches a final determination that an
OTP meets the requirements for certification in this section, the
Secretary will notify the Drug Enforcement Administration (DEA) that
the OTP has been determined to be qualified to provide OUD treatment
under section 303(g)(1) of the Controlled Substances Act.
(d) Provisional certification. New OTPs that have not received the
Secretary's certification previously, except as provided in paragraph
(a)(6) of this section, who are applying for certification from the
Secretary, and who have applied for accreditation with an Accreditation
Body, are eligible to receive provisional certification for up to 1
year. To receive provisional certification, an OTP shall submit the
information required by paragraph (b) of this section to the Secretary
along with a statement identifying the Accreditation Body to which the
OTP has applied for accreditation, the date on which the OTP applied
for accreditation, the dates of any accreditation surveys that have
taken place or are expected to take place, and the expected schedule
for completing the accreditation process. Provisional certification for
up to 1 year will be granted, following receipt of the information
described in this paragraph (d), unless the Secretary determines that
patient health would be adversely affected by the granting of
provisional certification.
(e) Requirements for certification. (1) OTPs shall comply with all
pertinent Federal and State laws and regulations. Nothing in this part
is intended to limit the authority of State and, as appropriate, local
governmental entities to regulate the use of MOUD in the treatment of
OUD. The provisions of this section requiring compliance with
requirements imposed by State law, or the submission of applications or
reports required by the State authority, do not apply to OTPs operated
directly by the Department of Veterans Affairs, the Indian Health
Service, or any other department or agency of the United States.
(2) OTPs shall allow, in accordance with Federal controlled
substances laws and Federal confidentiality laws, inspections and
surveys by duly authorized employees of the Department of Health and
Human Services (HHS) or Substance Abuse and Mental Health Services
Administration (SAMHSA), by Accreditation Bodies, by the Drug
Enforcement Administration (DEA), and by authorized employees of any
other Federal governmental entity with legal authority to conduct
inspections or surveys on an OTP's premises.
(3) Disclosure of patient records maintained by an OTP is governed
by the provisions of 42 CFR part 2 and 45 CFR parts 160 and 164, and
every program must comply with these regulations, as applicable.
Records on the receipt, storage, and distribution of MOUD are also
subject to inspection under Federal controlled substances laws and
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.).
Federally sponsored treatment programs are subject to applicable
Federal confidentiality statutes.
(4) An OTP or medication unit or any part thereof, including any
facility or any individual, shall permit a duly authorized employee of
the Department of Health and Human Services or SAMHSA to have access to
and to copy all records on the use of MOUD in accordance with the
provisions of 42 CFR part 2 and 45 CFR parts 160 and 164.
(5) OTPs shall notify the Secretary in writing within 3 weeks of
any replacement or other change in the status of the program sponsor or
medical director.
(6) OTPs shall comply with all regulations enforced by the DEA
under 21 CFR chapter II and must be registered by the DEA before
administering or dispensing MOUD.
(7) OTPs must operate in accordance with Federal Opioid Use
Disorder treatment standards and approved accreditation elements.
(f) Conditions for interim treatment program approval. (1) Before
an OTP may provide interim treatment, the OTP must receive the approval
of both the Secretary and the SOTA of the State in which the OTP
operates.
(2) Before the Secretary may grant such approval, the OTP must
provide the Secretary with documentation from the SOTA of the State in
which the OTP operates demonstrating that:
(i) Such officer does not object to the providing of interim
treatment in the State;
(ii) The OTP seeking to provide such treatment is unable to provide
access for patients in a comprehensive treatment program within a
reasonable geographic area within 14 days of the time patients seek
treatment for OUD;
(iii) The authorization of the OTP to provide interim treatment
will not otherwise reduce the capacity of comprehensive treatment
programs in the State to admit individuals (relative to the date on
which such officer so certifies); and
(iv) OTPs providing interim treatment will arrange for each
individual's transfer to a comprehensive treatment program no later
than 180 days from the date on which each individual first requested
treatment. Individuals enrolled in interim treatment shall not be
discharged without the approval of an OTP practitioner, who shall
consider on-going and patient-centered treatment needs, which are to be
documented in the patient record, while awaiting transfer to a
comprehensive treatment program.
(3) The Secretary will provide notice to the OTP denying or
approving the request to provide interim treatment. The OTP shall not
provide such treatment until it has received such notice from the
Secretary.
(g) Exemptions. An OTP may, at the time of application for
certification or any time thereafter, request from the Secretary
exemption from the regulatory requirements set forth under this section
and Sec. 8.12. An example of a case in which an exemption might be
granted would be for a private practitioner who
[[Page 7557]]
wishes to treat a limited number of patients in a non-metropolitan area
with few physicians and no OUD treatment services geographically
accessible, and requests exemption from some of the staffing and
service standards. The OTP shall support the rationale for the
exemption with thorough documentation, to be supplied in an appendix to
the initial application for certification or in a separate submission.
The Secretary will approve or deny such exemptions at the time of
application, or any time thereafter, if appropriate. The Secretary
shall consult with the appropriate State authority prior to taking
action on an exemption request.
(h) Medication units, long-term care facilities and hospitals. (1)
Certified OTPs may establish medication units that are authorized to
dispense MOUD. Before establishing a medication unit, a certified OTP
must notify the Secretary by submitting form SMA-162. The OTP must also
comply with the provisions of 21 CFR part 1300 before establishing a
medication unit. Medication units shall comply with all pertinent State
laws and regulations. Medication units include both mobile and brick
and mortar facilities.
(2) Specifically, any services that are provided in an OTP may be
provided in the medication unit, assuming compliance with all
applicable Federal, State, and local law, and the use of units that
provide appropriate privacy and have adequate space.
(3) Certification as an OTP under this part is not required for the
initiation or continuity of medication treatment or withdrawal
management of a patient who is admitted to a hospital, long-term care
facility, or correctional facility, that is registered with the Drug
Enforcement Administration as a hospital/clinic, for the treatment of
medical conditions other than OUD, and who requires treatment of OUD
with methadone during their stay, when such treatment is permitted
under applicable Federal law.
(i) The term ``long-term care facility'' is defined in Sec. 8.2.
Nothing in this section is intended to relieve hospitals, or long-term
care facilities and correctional facilities that are registered with
the Drug Enforcement Administration as a hospital/clinic, from their
obligations to obtain appropriate registration from the Attorney
General, under section 303(g) of the Controlled Substances Act.
Treatment provided under this section should always comply with
applicable Federal laws.
(ii) [Reserved]
Sec. 8.12 Federal Opioid Use Disorder treatment standards.
(a) General. OTPs must provide treatment in accordance with the
standards in this section and must comply with these standards as a
condition of certification.
(b) Administrative and organizational structure. (1) An OTP's
organizational structure and facilities shall be adequate to ensure
quality patient care and to meet the requirements of all pertinent
Federal, State, and local laws and regulations. At a minimum, each OTP
shall formally designate a program sponsor and medical director. The
program sponsor shall agree on behalf of the OTP to adhere to all
requirements set forth in this part.
(2) The medical director shall assume responsibility for all
medical and behavioral health services performed by the OTP. In
addition, the medical director shall be responsible for ensuring that
the OTP is in compliance with all applicable Federal, State, and local
laws and regulations.
(c) Continuous quality improvement. (1) An OTP must maintain
current quality assurance and quality control plans that include, among
other things, annual reviews of program policies and procedures and
ongoing assessment of patient outcomes.
(2) An OTP must maintain a current ``Diversion Control Plan'' or
``DCP'' as part of its quality assurance program that contains specific
measures to reduce the possibility of diversion of dispensed MOUD, and
that assigns specific responsibility to the OTP providers and
administrative staff for carrying out the diversion control measures
and functions described in the DCP.
(d) Staff credentials. Each person engaged in the treatment of OUD
must have sufficient education, training, and experience, or any
combination thereof, to enable that person to perform the assigned
functions. All practitioners and other licensed/certified health care
providers, including counselors, must comply with the credentialing and
maintenance of licensure and/or certification requirements of their
respective professions.
(e) Patient admission criteria--(1) Comprehensive treatment. An OTP
shall maintain current procedures designed to ensure that patients are
admitted to treatment by qualified personnel who have determined, using
accepted medical criteria, that: The person meets diagnostic criteria
for a moderate to severe OUD; the individual has an active moderate to
severe OUD, or OUD in remission, or is at high risk for recurrence or
overdose. Such decisions must be appropriately documented in the
patient's clinical record. In addition, a health care practitioner
shall ensure that each patient voluntarily chooses treatment with MOUD
and that all relevant facts concerning the use of MOUD are clearly and
adequately explained to the patient, and that each patient provides
informed consent to treatment.
(2) Comprehensive treatment for persons under age 18. Except in
States where State law grants persons under 18 years of age the ability
to consent to OTP treatment without the consent of another, no person
under 18 years of age may be admitted to OTP treatment unless a parent,
legal guardian, or responsible adult designated by the relevant State
authority consents in writing to such treatment.
(3) Withdrawal management. An OTP shall maintain current procedures
that are designed to ensure that those patients who choose to taper
from MOUD are provided the opportunity to do so with informed consent
and at a mutually agreed-upon rate that minimizes taper-related risks.
Such consent must be documented in the clinical record by the treating
practitioner.
(f) Required services--(1) General. OTPs shall provide adequate
medical, counseling, vocational, educational, and other screening,
assessment, and treatment services to meet patient needs, with the
combination and frequency of services tailored to each individual
patient based on an individualized assessment and the patient's care
plan that was created after shared decision making between the patient
and the clinical team. These services must be available at the primary
facility, except where the program sponsor has entered into a
documented agreement with a private or public agency, organization,
practitioner, or institution to provide these services to patients
enrolled in the OTP. The program sponsor, in any event, must be able to
document that these services are fully and reasonably available to
patients.
(2) Initial medical examination. (i) OTPs shall require each
patient to undergo an initial medical examination. The initial medical
examination is comprised of two parts:
(A) A screening examination to ensure that the patient meets
criteria for admission and that there are no contraindications to
treatment with MOUD; and
(B) A full history and examination, to determine the patient's
broader health status, with lab testing as determined to be required by
an appropriately licensed
[[Page 7558]]
practitioner. A patient's refusal to undergo lab testing for co-
occurring physical health conditions should not preclude them from
access to treatment, provided such refusal does not have potential to
negatively impact treatment with medications.
(ii) Assuming no contraindications, a patient may commence
treatment with MOUD after the screening examination has been completed.
Both the screening examination and full examination must be completed
by an appropriately licensed practitioner. If the licensed practitioner
is not an OTP practitioner, the screening examination must be completed
no more than seven days prior to OTP admission. Where the examination
is performed outside of the OTP, the written results and narrative of
the examination, as well as available lab testing results, must be
transmitted, consistent with applicable privacy laws, to the OTP, and
verified by an OTP practitioner.
(iii) A full in-person physical examination, including the results
of serology and other tests that are considered to be clinically
appropriate, must be completed within 14 calendar days following a
patient's admission to the OTP. The full exam can be completed by a
non-OTP practitioner, if the exam is verified by a licensed OTP
practitioner as being true and accurate and transmitted in accordance
with applicable privacy laws.
(iv) Serology testing and other testing as deemed medically
appropriate by the licensed OTP practitioner based on the screening or
full history and examination, drawn not more than 30 days prior to
admission to the OTP, may form part of the full history and
examination.
(v) The screening and full examination may be completed via
telehealth for those patients being admitted for treatment at the OTP
with either buprenorphine or methadone, if a practitioner or primary
care provider, determines that an adequate evaluation of the patient
can be accomplished via telehealth. When using telehealth, the
following caveats apply:
(A) In evaluating patients for treatment with schedule II
medications (such as Methadone), audio-visual telehealth platforms must
be used, except when not available to the patient. When not available,
it is acceptable to use audio-only devices, but only when the patient
is in the presence of a licensed practitioner who is registered to
prescribe (including dispense) controlled medications. The OTP
practitioner shall review the examination results and order treatment
medications as indicated.
(B) In evaluating patients for treatment with schedule III
medications (such as Buprenorphine) or medications not classified as a
controlled medication (such as Naltrexone), audio-visual or audio only
platforms may be used. The OTP practitioner shall review the
examination results and order treatment medications as indicated.
(3) Special services for pregnant patients. OTPs must maintain
current policies and procedures that reflect the special needs and
priority for treatment admission of patients with OUD who are pregnant.
Pregnancy should be confirmed. Evidence-based treatment protocols for
the pregnant patient, such as split dosing regimens, may be instituted
after assessment by an OTP practitioner and documentation that confirms
the clinical appropriateness of such an evidence-based treatment
protocol. Prenatal care and other sex-specific services, including
reproductive health services, for pregnant and postpartum patients must
be provided and documented either by the OTP or by referral to
appropriate healthcare practitioners. Specific services, including
reproductive health services, for pregnant and postpartum patients must
be provided and documented either by the OTP or by referral to
appropriate healthcare practitioners.
(4) Initial and periodic physical and behavioral health assessment
services. (i) Each patient admitted to an OTP shall be given a physical
and behavioral health assessment, which includes but is not limited to
screening for imminent risk of harm to self or others, within 14
calendar days following admission, and periodically by appropriately
licensed/credentialed personnel. These assessments must address the
need for and/or response to treatment, adjust treatment interventions,
including MOUD, as necessary, and provide a patient-centered plan of
care. The full, initial psychosocial assessment must be completed
within 14 calendar days of admission and include preparation of a care
plan that includes the patient's goals and mutually agreed-upon actions
for the patient to meet those goals, including harm reduction
interventions; the patient's needs and goals in the areas of education,
vocational training, and employment; and the medical and psychiatric,
psychosocial, economic, legal, housing, and other recovery support
services that a patient needs and wishes to pursue. The care plan also
must identify the recommended frequency with which services are to be
provided. The plan must be reviewed and updated to reflect responses to
treatment and recovery support services, and adjustments made that
reflect changes in the context of the person's life, their current
needs for and interests in medical, psychiatric, social, and
psychological services, and current needs for and interests in
education, vocational training, and employment services.
(ii) The periodic physical examination should occur not less than
one time each year and be conducted by an OTP practitioner. The
periodic physical examination should include review of MOUD dosing,
treatment response, other substance use disorder treatment needs,
responses and patient-identified goals, and other relevant physical and
psychiatric treatment needs and goals. The periodic physical
examination should be documented in the patient's clinical record.
(5) Counseling and psychoeducational services. (i) OTPs must
provide adequate substance use disorder counseling and psychoeducation
to each patient as clinically necessary and mutually agreed-upon,
including harm reduction education and recovery-oriented counseling.
This counseling shall be provided by a program counselor, qualified by
education, training, or experience to assess the psychological and
sociological background of patients, and engage with patients, to
contribute to the appropriate care plan for the patient and to monitor
and update patient progress. Patient refusal of counseling shall not
preclude them from receiving MOUD.
(ii) OTPs must provide counseling on preventing exposure to, and
the transmission of, human immunodeficiency virus (HIV), viral
hepatitis, and sexually transmitted infections (STIs) and either
directly provide services and treatments or actively link to treatment
each patient admitted or readmitted to treatment who has received
positive test results for these conditions from initial and/or periodic
medical examinations.
(iii) OTPs must provide directly, or through referral to adequate
and reasonably accessible community resources, vocational training,
education, and employment services for patients who request such
services or for whom these needs have been identified and mutually
agreed-upon as beneficial by the patient and program staff.
(6) Drug testing services. When conducting random drug testing,
OTPs must use drug tests that have received the Food and Drug
Administration's (FDA) marketing authorization for commonly used and
misused substances that may impact patient safety, recovery, or
otherwise complicate substance use disorder treatment, at a frequency
that is
[[Page 7559]]
in accordance with generally accepted clinical practice and as
indicated by a patient's response to and stability in treatment, but no
fewer than eight random drug tests per year patient, allowing for
extenuating circumstances at the individual patient level. This
requirement does not preclude distribution of legal harm reduction
supplies that allow an individual to test their personal drug supply
for adulteration with substances that increase the risk of overdose.
(g) Recordkeeping and patient confidentiality. (1) OTPs shall
establish and maintain a recordkeeping system that is adequate to
document and monitor patient care. This system is required to comply
with all Federal and State reporting requirements relevant to MOUD
approved for use in treatment of OUD. All records are required to be
kept confidential in accordance with all applicable Federal and State
requirements.
(2) OTPs shall include, as an essential part of the recordkeeping
system, documentation in each patient's record that the OTP made a good
faith effort to determine whether the patient is enrolled in any other
OTP. A patient enrolled in an OTP shall not be permitted to obtain
treatment in any other OTP except in circumstances involving an
inability to access care at the patient's OTP of record. Such
circumstances include, but are not limited to, travel for work or
family events, temporary relocation, or an OTP's temporary closure. If
the medical director or program practitioner of the OTP in which the
patient is enrolled determines that such circumstances exist, the
patient may seek treatment at another OTP, provided the justification
for the particular circumstances are noted in the patient's record both
at the OTP in which the patient is enrolled and at the OTP that will
provide the MOUD.
(h) Medication administration, dispensing, and use. (1) OTPs must
ensure that MOUD are administered or dispensed only by a practitioner
licensed under the appropriate State law and registered under the
appropriate State and Federal laws to administer or dispense MOUD, or
by an agent of such a practitioner, supervised by and under the order
of the licensed practitioner and if consistent with Federal and State
law.
(2) OTPs shall use only those MOUD that are approved by the Food
and Drug Administration under section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) for use in the treatment of OUD. In
addition, OTPs who are fully compliant with the protocol of an
investigational use of a drug and other conditions set forth in the
application may administer a drug that has been authorized by the Food
and Drug Administration under an investigational new drug application
under section 505(i) of the Federal Food, Drug, and Cosmetic Act for
investigational use in the treatment of OUD. Currently the following
MOUD will be considered to be approved by the Food and Drug
Administration for use in the treatment of OUD:
(i) Methadone;
(ii) Buprenorphine and buprenorphine combination products that have
been approved for use in the treatment of OUD; and
(iii) Naltrexone.
(3) OTPs shall maintain current procedures that are adequate to
ensure that the following dosage form and initial dosing requirements
are met:
(i) Methadone shall be administered or dispensed only in oral form
and shall be formulated in such a way as to reduce its potential for
parenteral misuse.
(ii) For each new patient enrolled in an OTP, the initial dose of
methadone shall be individually determined and shall include
consideration of the type(s) of opioid(s) involved in the patient's
opioid use disorder, other medications or substances being taken,
medical history, and severity of opioid withdrawal. The total dose for
the first day should not exceed 50 milligrams unless the OTP
practitioner, licensed under the appropriate State law and registered
under the appropriate State and Federal laws to administer or dispense
MOUD, finds sufficient medical rationale, including but not limited to
if the patient is transferring from another OTP on a higher dose that
has been verified, and documents in the patient's record that a higher
dose was clinically indicated.
(4) OTPs shall maintain current procedures adequate to ensure that
each MOUD used by the program is administered and dispensed in
accordance with its FDA approved product labeling. The program must
ensure that any significant deviations from the approved labeling,
including deviations with regard to dose, frequency, or the conditions
of use described in the approved labeling, are specifically documented
in the patient's record.
(i) Unsupervised or ``take-home'' medication doses. Unsupervised or
``take-home'' medication doses may be provided under the following
circumstances:
(1) Any patient in comprehensive treatment may receive their
individualized take-home doses as ordered for days that the clinic is
closed for business, including one weekend day (e.g., Sunday) and State
and Federal holidays, no matter their length of time in treatment.
(2) OTP decisions on dispensing MOUD to patients for unsupervised
use beyond that set forth in paragraph (i)(1) of this section shall be
determined by an appropriately licensed OTP medical practitioner or the
medical director. In determining which patients may receive
unsupervised medication doses, the medical director or program medical
practitioner shall consider, among other pertinent factors that
indicate that the therapeutic benefits of unsupervised doses outweigh
the risks, the following criteria:
(i) Absence of active substance use disorders, other physical or
behavioral health conditions that increase the risk of patient harm as
it relates to the potential for overdose, or the ability to function
safely;
(ii) Regularity of attendance for supervised medication
administration;
(iii) Absence of serious behavioral problems that endanger the
patient, the public or others;
(iv) Absence of known recent diversion activity;
(v) Whether take-home medication can be safely transported and
stored; and
(vi) Any other criteria that the medical director or medical
practitioner considers relevant to the patient's safety and the
public's health.
(3) Such determinations and the basis for such determinations
consistent with the criteria outlined in paragraph (i)(2) of this
section shall be documented in the patient's medical record. If it is
determined that a patient is safely able to manage unsupervised doses
of MOUD, the dispensing restrictions set forth in paragraphs (i)(3)(i)
through (iii) of this section apply. The dispensing restrictions set
forth in paragraphs (i)(3)(i) through (iii) of this section do not
apply to buprenorphine and buprenorphine products listed under
paragraph (h)(2)(ii) of this section.
(i) During the first 14 days of treatment, the take-home supply
(beyond that of paragraph (i)(1) of this section) is limited to 7 days.
It remains within the OTP practitioner's discretion to determine the
number of take-home doses up to 7 days, but decisions must be based on
the criteria listed in paragraph (i)(2) of this section. The rationale
underlying the decision to provide unsupervised doses of methadone must
be documented in the patient's clinical record, consistent with
paragraph (g)(2) of this section.
[[Page 7560]]
(ii) From 15 days of treatment, the take-home supply (beyond that
of paragraph (i)(1) of this section) is limited to 14 days. It remains
within the OTP practitioner's discretion to determine the number of
take-home doses up to 14 days, but this determination must be based on
the criteria listed in paragraph (i)(2) of this section. The rationale
underlying the decision to provide unsupervised doses of methadone must
be documented in the patient's clinical record, consistent with
paragraph (g)(2) of this section.
(iii) From 31 days of treatment, the take-home supply (beyond that
of paragraph (i)(1) of this section) provided to a patient is not to
exceed 28 days. It remains within the OTP practitioner's discretion to
determine the number of take-home doses up to 28 days, but this
determination must be based on the criteria listed in paragraph (i)(2)
of this section. The rationale underlying the decision to provide
unsupervised doses of methadone must be documented in the patient's
clinical record, consistent with paragraph (g)(2) of this section.
(4) OTPs must maintain current procedures adequate to identify the
theft or diversion of take-home medications, including labeling
containers with the OTP's name, address, and telephone number. Programs
also must ensure that each individual take-home dose is packaged in a
manner that is designed to reduce the risk of accidental ingestion,
including child-proof containers (see Poison Prevention Packaging Act,
Pub. L. 91-601 (15 U.S.C. 1471 et seq.)). Programs must provide
education to each patient on: Safely transporting medication from the
OTP to their place of residence; and the safe storage of take-home
doses at the individual's place of residence, including child and
household safety precautions. The provision of this education should be
documented in the patient's clinical record.
(j) Interim treatment. (1) The program sponsor of an OTP may admit
an individual, who is eligible for admission to comprehensive
treatment, into interim treatment if comprehensive services are not
readily available within a reasonable geographic area and within 14
days of the individual's seeking treatment. At least two drug tests
shall be obtained from patients during the maximum of 180 days
permitted for interim treatment. A program shall establish and follow
reasonable criteria for establishing priorities for moving patients
from interim to comprehensive treatment. These transition criteria
shall be in writing and shall include, at a minimum, prioritization of
pregnant patients in admitting patients to interim treatment and from
interim to comprehensive treatment. Interim treatment shall be provided
in a manner consistent with all applicable Federal and State laws,
including sections 1923, 1927(a), and 1976 of the Public Health Service
Act (21 U.S.C. 300x-23, 300x-27(a), and 300y-11).
(2) The program shall notify the SOTA when a patient begins interim
treatment, when a patient leaves interim treatment, and before the date
of transfer to comprehensive services, and shall document such
notifications.
(3) The Secretary may revoke the interim authorization for programs
that fail to comply with the provisions of this paragraph (j).
Likewise, the Secretary will consider revoking the interim
authorization of a program if the State in which the program operates
is not in compliance with the provisions of Sec. 8.11(h).
(4) All requirements for comprehensive treatment apply to interim
treatment with the following exceptions:
(i) A primary counselor is not required to be assigned to the
patient, but crisis services, including shelter support, should be
available;
(ii) Interim treatment cannot be provided for longer than 180 days
in any 12-month period;
(iii) By day 120, a plan for continuing treatment beyond 180 days
must be created, and documented in the patient's clinical record; and
(iv) Formal counseling, vocational training, employment, economic,
legal, educational, and other recovery support services described in
paragraphs (f)(4) and (f)(5)(i) and (iii) of this section are not
required to be offered to the patient. However, information pertaining
to locally available, community-based resources for ancillary services
should be made available to individual patients in interim treatment.
Sec. 8.13 Revocation of accreditation and Accreditation Body
approval.
(a) The Secretary's action following revocation of accreditation.
If an Accreditation Body revokes an OTP's accreditation, the Secretary
may conduct an investigation into the reasons for the revocation.
Following such investigation, the Secretary may determine that the
OTP's certification should no longer be in effect, at which time the
Secretary will initiate procedures to revoke the program's
certification in accordance with Sec. 8.14. Alternatively, the
Secretary may determine that another action or combination of actions
would better serve the public health, including the establishment and
implementation of a corrective plan of action that will permit the
certification to continue in effect while the OTP seeks
reaccreditation.
(b) Accreditation Body approval. (1) If the Secretary withdraws the
approval of an Accreditation Body under Sec. 8.6, the certifications
of OTPs accredited by such Body shall remain in effect for a period of
1 year after the date of withdrawal of approval of the Accreditation
Body, unless the Secretary determines that to protect public health or
safety, or because the Accreditation Body fraudulently accredited
treatment programs, the certifications of some or all of the programs
should be revoked or suspended or that a shorter time period should be
established for the certifications to remain in effect. The Secretary
may extend the time in which a certification remains in effect under
this paragraph (b)(1) on a case-by-case basis.
(2) Within 1 year from the date of withdrawal of approval of an
Accreditation Body, or within any shorter period of time established by
the Secretary, OTPs currently accredited by the Accreditation Body must
obtain accreditation from another Accreditation Body. The Secretary may
extend the time period for obtaining reaccreditation on a case-by-case
basis.
Sec. 8.14 Suspension or revocation of certification.
(a) Revocation. Except as provided in paragraph (b) of this
section, the Secretary may revoke the certification of an OTP if the
Secretary finds, after providing the program sponsor with notice and an
opportunity for a hearing in accordance with this subpart, that the
program sponsor, or any employee of the OTP:
(1) Has been found to have engaged in misrepresentation in
obtaining the certification;
(2) Has failed to comply with the Federal Opioid Use Disorder
treatment standards in any respect;
(3) Has failed to comply with reasonable requests from the
Secretary or from an Accreditation Body for records, information,
reports, or materials that are necessary to determine the continued
eligibility of the OTP for certification or continued compliance with
the Federal Opioid Use Disorder treatment standards; or
(4) Has refused a reasonable request of a duly designated
inspector, Drug Enforcement Administration (DEA) Inspector, State
Inspector, or Accreditation Body representative for permission to
inspect the program or the program's operations or its records.
[[Page 7561]]
(b) Suspension. Whenever the Secretary has reason to believe that
revocation may be required and that immediate action is necessary to
protect public health or safety, the Secretary may immediately suspend
the certification of an OTP, and notify the Attorney General that the
OTP's registration should be suspended, before holding a hearing under
this subpart. The Secretary may immediately suspend as well as propose
revocation of the certification of an OTP before holding a hearing
under this subpart if the Secretary makes a finding described in
paragraph (a) of this section and also determines that:
(1) The failure to comply with the Federal Opioid Use Disorder
treatment standards presents an imminent danger to the public health or
safety;
(2) The refusal to permit inspection makes immediate suspension
necessary; or
(3) There is reason to believe that the failure to comply with the
Federal Opioid Use Disorder treatment standards was intentional or was
associated with fraud.
(c) Written notification. In the event that the Secretary suspends
the certification of an OTP in accordance with paragraph (b) of this
section or proposes to revoke the certification of an OTP in accordance
with paragraph (a) of this section, the Secretary shall promptly
provide the sponsor of the OTP with written notice of the suspension or
proposed revocation by facsimile transmission, personal service,
commercial overnight delivery service, or certified mail, return
receipt requested. Such notice shall state the reasons for the action,
state that the OTP may seek review of the action in accordance with the
procedures in this subpart, and identify the reviewing official to whom
a written request for review may be submitted.
(d) Procedure. (1) If the Secretary suspends certification in
accordance with paragraph (b) of this section:
(i) The Secretary will immediately notify DEA that the OTP's
registration should be suspended under 21 U.S.C. 824(d); and
(ii) the Secretary will provide an opportunity for a hearing under
this subpart.
(2) Suspension of certification under paragraph (b) of this section
shall remain in effect until the agency determines that:
(i) The basis for the suspension cannot be substantiated;
(ii) Violations of required standards have been corrected to the
agency's satisfaction; or
(iii) The OTP's certification shall be revoked.
Sec. 8.15 Forms.
(a) SMA-162--Application for Certification to Use Medications for
Opioid Use Disorder.
(b) SMA-163--Application for Becoming an Accreditation Body under
Sec. 8.3.
Subpart D--Procedures for Informal Review of Suspension or Proposed
Revocation of OTP Certification, and of Adverse Action Regarding
Withdrawal of Approval of an Accreditation Body
Sec. 8.21 Applicability.
The procedures in this subpart apply when:
(a) The Secretary has notified an OTP in writing that its
certification under the regulations in subpart B of this part has been
suspended or that the Secretary proposes to revoke the certification;
and
(b) The OTP has, within 30 days of the date of the notification or
within 3 days of the date of the notification when seeking an expedited
review of a suspension, requested in writing to the reviewing official,
an opportunity for an informal review of the suspension or proposed
revocation.
(c) The Secretary has notified an Accreditation Body of an adverse
action taken regarding withdrawal of approval of the Accreditation Body
under the regulations in subpart A of this part; and
(d) The Accreditation Body has, within 30 days of the date of the
notification, requested in writing an opportunity for a review of the
adverse action.
Sec. 8.22 Definitions.
The following definitions apply to this subpart:
Appellant means:
(1) The OTP which has been notified of its suspension or proposed
revocation of its certification under the regulations of this part and
has requested a review of the suspension or proposed revocation; or
(2) The Accreditation Body which has been notified of adverse
action regarding withdrawal of approval under the regulations of this
subpart and has requested a review of the adverse action.
Respondent means SAMHSA.
Reviewing official means the person or persons designated by the
Secretary who will informally review the suspension or proposed
revocation. The reviewing official may be assisted by one or more
Department of Health and Human Services (HHS) officers or employees or
consultants in assessing and weighing the scientific and technical
evidence and other information submitted by the appellant and
respondent on the reasons for the suspension and proposed revocation.
Sec. 8.23 Limitation on issues subject to review.
The scope of this informal review shall be limited to the facts
relevant to any suspension, or proposed revocation, or adverse action,
the necessary interpretations of the facts, the regulations in this
subpart, and other relevant law.
Sec. 8.24 Specifying who represents the parties.
The appellant's request for an informal review shall specify the
name, address, and phone number of the appellant's representative. In
its first written submission to the reviewing official, the respondent
shall specify the name, address, and phone number of the respondent's
representative.
Sec. 8.25 Informal review and the reviewing official's response.
(a) Request for review. Within 30 days of the date of the notice of
the suspension or proposed revocation, the appellant must submit a
written request to the reviewing official seeking review, unless some
other time period is agreed to by the parties. A copy must also be sent
to the respondent. The request for review must include a copy of the
notice of suspension, proposed revocation, or adverse action, a brief
statement of why the decision to suspend, propose revocation, or take
an adverse action is incorrect, and the appellant's request for an oral
presentation, if desired.
(b) Acknowledgment. Within 5 days after receiving the request for
review, the reviewing official will send an acknowledgment and advise
the appellant of the next steps. The reviewing official will also send
a copy of the acknowledgment to the respondent.
Sec. 8.26 Preparation of the review file and written arguments.
The appellant and the respondent each participate in developing the
file for the reviewing official and in submitting written arguments.
The procedures for development of the review file and submission of
written argument are:
(a) Appellant's documents and brief. Within 30 days after receiving
the acknowledgment of the request for review, the appellant shall
submit to the reviewing official the following (with a copy to the
respondent):
(1) A review file containing the documents supporting appellant's
[[Page 7562]]
argument, tabbed and organized chronologically, and accompanied by an
index identifying each document. Only essential documents should be
submitted to the reviewing official.
(2) A written statement, not to exceed 20 double-spaced pages,
explaining why respondent's decision to suspend or propose revocation
of appellant's certification or to take adverse action regarding
withdrawal of approval of the Accreditation Body is incorrect
(appellant's brief).
(b) Respondent's documents and brief. Within 30 days after
receiving a copy of the acknowledgment of the request for review, the
respondent shall submit to the reviewing official the following (with a
copy to the appellant):
(1) A review file containing documents supporting respondent's
decision to suspend or revoke appellant's certification, or approval as
an Accreditation Body, tabbed and organized chronologically, and
accompanied by an index identifying each document. Only essential
documents should be submitted to the reviewing official.
(2) A written statement, not exceeding 20 double-spaced pages in
length, explaining the basis for suspension, proposed revocation, or
adverse action (respondent's brief).
(c) Reply briefs. Within 10 days after receiving the opposing
party's submission, or 20 days after receiving acknowledgment of the
request for review, whichever is later, each party may submit a short
reply not to exceed 10 double-spaced pages.
(d) Cooperative efforts. Whenever feasible, the parties should
attempt to develop a joint review file.
(e) Excessive documentation. The reviewing official may take any
appropriate steps to reduce excessive documentation, including the
return of or refusal to consider documentation found to be irrelevant,
redundant, or unnecessary.
(f) Discovery. The use of interrogatories, depositions, and other
forms of discovery shall not be allowed.
Sec. 8.27 Opportunity for oral presentation.
(a) Electing oral presentation. If an opportunity for an oral
presentation is desired, the appellant shall request it at the time it
submits its written request for review to the reviewing official. The
reviewing official will grant the request if the official determines
that the decision-making process will be substantially aided by oral
presentations and arguments. The reviewing official may also provide
for an oral presentation at the official's own initiative or at the
request of the respondent.
(b) Presiding official. The reviewing official or designee will be
the presiding official responsible for managing the oral presentations.
(c) Preliminary conference. The presiding official may hold a
prehearing conference (usually a telephone conference call) to consider
any of the following: Simplifying and clarifying issues; stipulations
and admissions; limitations on evidence and witnesses that will be
presented at the hearing; time allotted for each witness and the
hearing altogether; scheduling the hearing; and any other matter that
will assist in the review process. Normally, this conference will be
conducted informally and off the record; however, the presiding
official may, at the presiding official's discretion, produce a written
document summarizing the conference or transcribe the conference.
(d) Time and place of oral presentation. The presiding official
will attempt to schedule the oral presentation within 45 days of the
date appellant's request for review is received or within 15 days of
submission of the last reply brief, whichever is later. The oral
presentation will be held at a time and place determined by the
presiding official following consultation with the parties.
(e) Conduct of the oral presentation--(1) General. The presiding
official is responsible for conducting the oral presentation. The
presiding official may be assisted by one or more HHS officers or
employees or consultants in conducting the oral presentation and
reviewing the evidence. While the oral presentation will be kept as
informal as possible, the presiding official may take all necessary
steps to ensure an orderly proceeding.
(2) Burden of proof/standard of proof. In all cases, the respondent
bears the burden of proving by a preponderance of the evidence that its
decision to suspend, propose revocation, or take adverse action is
appropriate. The appellant, however, has a responsibility to respond to
the respondent's allegations with evidence and argument to show that
the respondent is incorrect.
(3) Admission of evidence. The rules of evidence do not apply, and
the presiding official will generally admit all testimonial evidence
unless it is clearly irrelevant, immaterial, or unduly repetitious.
Each party may make an opening and closing statement, may present
witnesses as agreed upon in the pre-hearing conference or otherwise,
and may question the opposing party's witnesses. Since the parties have
ample opportunity to prepare the review file, a party may introduce
additional documentation during the oral presentation only with the
permission of the presiding official. The presiding official may
question witnesses directly and take such other steps necessary to
ensure an effective and efficient consideration of the evidence,
including setting time limitations on direct and cross-examinations.
(4) Motions. The presiding official may rule on motions including,
for example, motions to exclude or strike redundant or immaterial
evidence, motions to dismiss the case for insufficient evidence, or
motions for summary judgment. Except for those made during the hearing,
all motions and opposition to motions, including argument, must be in
writing and be no more than 10 double-spaced pages in length. The
presiding official will set a reasonable time for the party opposing
the motion to reply.
(5) Transcripts. The presiding official shall have the oral
presentation transcribed. Either party may request a copy of the
transcript and the requesting party shall be responsible for paying for
its copy of the transcript.
(f) Obstruction of justice or making of false statements.
Obstruction of justice or the making of false statements by a witness
or any other person may be the basis for a criminal prosecution under
18 U.S.C. 1001 or 1505.
(g) Post-hearing procedures. At the presiding official's
discretion, the presiding official may require or permit the parties to
submit post-hearing briefs or proposed findings and conclusions. Each
party may submit comments on any major prejudicial errors in the
transcript.
Sec. 8.28 Expedited procedures for review of immediate suspension.
(a) Applicability. When the Secretary notifies an OTP in writing
that its certification has been immediately suspended, the appellant
may request an expedited review of the suspension and any proposed
revocation. The appellant must submit this request in writing to the
reviewing official within 10 days of the date the OTP received notice
of the suspension. The request for review must include a copy of the
suspension and any proposed revocation, a brief statement of why the
decision to suspend and propose revocation is incorrect, and the
appellant's request for an oral presentation, if desired. A copy of the
request for review must also be sent to the respondent.
(b) Reviewing official's response. As soon as practicable after the
request for review is received, the reviewing official
[[Page 7563]]
will send an acknowledgment with a copy to the respondent.
(c) Review file and briefs. Within 10 days of the date the request
for review is received, but no later than 2 days before an oral
presentation, each party shall submit to the reviewing official the
following:
(1) A review file containing essential documents relevant to the
review, tabbed, indexed, and organized chronologically; and
(2) A written statement, not to exceed 20 double-spaced pages,
explaining the party's position concerning the suspension and any
proposed revocation. No reply brief is permitted.
(d) Oral presentation. If an oral presentation is requested by the
appellant or otherwise granted by the reviewing official in accordance
with Sec. 8.27(a), the presiding official will attempt to schedule the
oral presentation within 20 to 30 days of the date of appellant's
request for review at a time and place determined by the presiding
official following consultation with the parties. The presiding
official may hold a pre-hearing conference in accordance with Sec.
8.27(c) and will conduct the oral presentation in accordance with the
procedures of Sec. 8.27(e), (f), and (g).
(e) Written decision. The reviewing official shall issue a written
decision upholding or denying the suspension or proposed revocation and
will attempt to issue the decision within 7 to 10 days of the date of
the oral presentation or within 3 days of the date on which the
transcript is received or the date of the last submission by either
party, whichever is later. All other provisions set forth in Sec. 8.33
apply.
(f) Transmission of written communications. Because of the
importance of timeliness for the expedited procedures in this section,
all written communications between the parties and between either party
and the reviewing official shall be sent by facsimile transmission,
personal service, or commercial overnight delivery service.
Sec. 8.29 Ex parte communications.
For the purposes of maintaining the equity of informal review
proceedings, except for routine administrative and procedural matters
or as described in Sec. Sec. 8.22(2) and 8.27(e), a party shall not
communicate with the reviewing or presiding official without notice to
the other party.
Sec. 8.30 Transmission of written communications by reviewing
official and calculation of deadlines.
(a) Timely review. Because of the importance of a timely review,
the reviewing official should normally transmit written communications
to either party by facsimile transmission, personal service, or
commercial overnight delivery service, or certified mail, return
receipt requested, in which case the date of transmission or day
following mailing will be considered the date of receipt. In the case
of communications sent by regular mail, the date of receipt will be
considered 3 days after the date of mailing.
(b) Due date. In counting days, include Saturdays, Sundays, and
holidays. However, if a due date falls on a Saturday, Sunday, or
Federal holiday, then the due date is the next Federal working day.
Sec. 8.31 Authority and responsibilities of the reviewing official.
In addition to any other authority specified in this subpart, the
reviewing official and the presiding official, with respect to those
authorities involving the oral presentation, shall have the authority
to issue orders; examine witnesses; take all steps necessary for the
conduct of an orderly hearing; rule on requests and motions; grant
extensions of time for good reasons; dismiss for failure to meet
deadlines or other requirements; order the parties to submit relevant
information or witnesses; remand a case for further action by the
respondent; waive or modify the procedures in this subpart in a
specific case, usually with notice to the parties; reconsider a
decision of the reviewing official where a party promptly alleges a
clear error of fact or law; and to take any other action necessary to
resolve disputes in accordance with the objectives of the procedures in
this subpart.
Sec. 8.32 Administrative record.
The administrative record of review consists of the review file;
other submissions by the parties; transcripts or other records of any
meetings, conference calls, or oral presentation; evidence submitted at
the oral presentation; and orders and other documents issued by the
reviewing and presiding officials.
Sec. 8.33 Written decision.
(a) Issuance of decision. The reviewing official shall issue a
written decision upholding or denying the suspension, proposed
revocation, or adverse action. The decision will set forth the reasons
for the decision and describe the basis for that decision in the
record. Furthermore, the reviewing official may remand the matter to
the respondent for such further action as the reviewing official deems
appropriate.
(b) Date of decision. The reviewing official will attempt to issue
the decision within 15 days of the date of the oral presentation, the
date on which the transcript is received, or the date of the last
submission by either party, whichever is later. If there is no oral
presentation, the decision will normally be issued within 15 days of
the date of receipt of the last reply brief. Once issued, the reviewing
official will immediately communicate the decision to each party.
(c) Public notice and communications to the Drug Enforcement
Administration (DEA). (1) If the suspension and proposed revocation of
OTP certification are upheld, the revocation of certification will
become effective immediately and the public will be notified by
publication of a notice in the Federal Register. The Secretary will
notify DEA within 5 days that the OTP's registration should be revoked.
(2) If the suspension and proposed revocation of OTP certification
are denied, the revocation will not take effect and the suspension will
be lifted immediately. Public notice will be given by publication in
the Federal Register. The Secretary will notify DEA within 5 days that
the OTP's registration should be restored, if applicable.
Sec. 8.34 Court review of final administrative action; exhaustion of
administrative remedies.
Before any legal action is filed in court challenging the
suspension, proposed revocation, or adverse action, respondent shall
exhaust administrative remedies provided under this subpart, unless
otherwise provided by Federal law. The reviewing official's decision,
under Sec. 8.28(e) or Sec. 8.33(a), constitutes final agency action
as of the date of the decision.
Subpart E [Reserved]
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-01693 Filed 1-31-24; 4:15 pm]
BILLING CODE 4162-20-P