Medications for the Treatment of Opioid Use Disorder, 77330-77365 [2022-27193]
Download as PDF
<![CDATA[
77330
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
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.
ACTION: Notice of proposed rulemaking.
AGENCY:
The Department of Health and
Human Services (HHS or ‘‘the
Department’’) is issuing this notice of
proposed rulemaking (NPRM) to solicit
public comment on its proposal to
modify its regulations regarding
medications for the treatment of opioid
use disorder.
DATES: Comments due on or before
February 14, 2023.
ADDRESSES: Written comments may be
submitted through any of the methods
specified below. Please do not submit
duplicate comments.
• Federal eRulemaking Portal: You
may submit electronic comments at
https://www.regulations.gov. Follow the
instructions at https://
www.regulations.gov for submitting
electronic comments. Attachments
should be in Microsoft Word or Portable
Document Format (PDF), and please
refer to RIN 0930–AA39 in all
comments.
• Regular, Express, or Overnight Mail:
You may mail written comments (one
original and two copies) to the following
address only: The Substance Abuse and
Mental Health Services Administration,
Center for Substance Abuse Treatment,
5600 Fishers Lane, Room 13–E–30,
Rockville, MD 20857.
SUMMARY:
lotter on DSK11XQN23PROD with PROPOSALS3
Note: Due to the COVID–19 pandemic,
SAMHSA notes receipt of mail may be
delayed and encourages submission of
comments electronically to the docket.
Inspection of Public Comments: All
comments received by the accepted
methods and due date specified above
may be posted without change to
content to https://www.regulations.gov,
which may include personal
information provided about the
commenter, and such posting may occur
after the closing of the comment period.
However, the Department may redact
certain content from comments before
posting, including threatening language,
hate speech, profanity, graphic images,
or individually identifiable information
about a third-party individual other
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
than the commenter. Because of the
large number of public comments
normally received on Federal Register
documents, SAMHSA is not able to
provide individual acknowledgments of
receipt. Please allow sufficient time for
mailed comments to be received timely
in the event of delivery or security
delays. Comments submitted by fax or
email, and those submitted after the
comment period will not be accepted.
FOR FURTHER INFORMATION CONTACT:
Robert Baillieu, MD, MPH, Physician
and Senior Advisor, SAMHSA/CSAT,
5600 Fishers Lane, Room 13–E–30,
Rockville, MD 20857, Phone: 202–923–
0996, Email: Robert.Baillieu@
samhsa.hhs.gov.
The
discussion below includes an Executive
Summary and overview describing the
need for the proposed rule changes, a
section-by-section description of the
proposed modifications, and the impact
statement and other required regulatory
analyses. The Department solicits public
comment on all aspects of the proposed
rule. Persons interested in commenting
on the provisions of the proposed rules
can assist the Department by preceding
discussion of any particular provision or
topic with a citation to the section of the
proposed rule being discussed.
SUPPLEMENTARY INFORMATION:
Executive Summary
A. Overview
The Controlled Substances Act (CSA),
under 21 U.S.C. 823(g)(1), requires
‘‘practitioners who dispense narcotic
drugs to individuals for maintenance
treatment or detoxification treatment’’ to
‘‘obtain annually a separate registration
for that purpose’’ except as provided
under 21 U.S.C. 823(g)(2). Section
823(g)(1) also provides that, ‘‘[t]he
Attorney General shall register an
applicant to dispense narcotic drugs to
individuals for maintenance treatment
or detoxification treatment (or both)’’ if,
among other things, the applicant ‘‘is
determined by the Secretary to be
qualified (under standards established
by the Secretary [of HHS]) to engage in
the treatment with respect to which
registration is sought[,]’’ and ‘‘if the
Secretary determines that the applicant
will comply with standards established
by the Secretary (after consultation with
the Attorney General) respecting the
quantities of narcotic drugs which may
be provided for unsupervised use by
individuals in such treatment.’’ 21
U.S.C. 823(g)(1)(A)–(C). The standards
authorized under section 823(g)(1) have
been published as regulations under
part 8 of title 42 of the Code of Federal
PO 00000
Frm 00002
Fmt 4701
Sfmt 4702
Regulations (42 CFR part 8 or ‘‘part 8’’).1
Among other things, these regulations
establish the procedures by which the
Secretary of HHS determines whether a
program is qualified to dispense opioid
agonist medications in the treatment of
opioid use disorders, and standards
regarding the appropriate quantities of
opioid agonist medications that may be
provided for unsupervised use by
individuals undergoing such treatment.
See 42 CFR 8.1. In addition, ‘‘a program
or practitioner engaged in opioid
treatment of individuals with an opioid
agonist treatment medication’’ that is
also ‘‘registered under 21 U.S.C.
823(g)(1)’’ is described as an ‘‘Opioid
Treatment Program’’ (OTP). See 42 CFR
8.2.2 The statue, at 21 U.S.C. 823(g)(2),
also authorizes a waiver from the
registration requirements of 21 U.S.C.
823(g)(1) for qualifying practitioners
seeking to dispense or prescribe
schedule III, IV, or V controlled
substances that are Food and Drug
Administration (FDA)-approved for use
in ‘‘maintenance and detoxification
treatment.’’ Practitioners with a waiver
under section 823(g)(2) are limited in
the number of patients with opioid use
disorder they may treat at any one time,
and depending on the practitioner’s
experience or qualifications, this
statutory limitation is set at either 30,
100, or 275. See 21 U.S.C.
823(g)(2)(B)(iii). The Secretary is also
authorized to change the patient
limitations by regulation, and qualifying
practitioners must satisfy the
requirements of 42 CFR 8.610 through
8.655 ‘‘(or successor regulations)’’ in
order to treat up to 275 patients, which
is the maximum number under existing
law. See 21 U.S.C.
823(g)(2)(B)(iii)(II)(dd).3
In this NPRM, the Department
proposes to modify certain provisions of
part 8 to update OTP accreditation and
certification standards, treatment
standards for the provision of
medications for opioid use disorder
(MOUD) as dispensed by OTPs, and
requirements for individual
1 For 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.
2 The terms ‘‘narcotic drugs’’ and ‘‘detoxification
treatment’’ included in this paragraph are found in
statute. SAMHSA recognizes that these terms can be
stigmatizing for some people, and not aligned with
current terminology. SAMHSA uses ‘‘opioid agonist
medications’’ (see Treatment Improvement Protocol
(TIP) 63) as an alternative to ‘‘narcotic drugs’’ and
‘‘withdrawal management’’ as the alternative to
‘‘detoxification treatment’’.
3 See https://www.govinfo.gov/content/pkg/
USCODE-2016-title21/html/USCODE-2016-title21chap13-subchapI-partC-sec823.htm.
E:\FR\FM\16DEP3.SGM
16DEP3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS3
practitioners eligible to dispense
(including by prescribing) certain types
of MOUD with a waiver under 21 U.S.C.
823(g)(2).
The proposal draws on experience
from the COVID–19 Public Health
Emergency (PHE), as well as more than
20 years of practice-based research. The
COVID–19 PHE necessitated changes to
policy guidance and legal exemptions to
protect the public’s health, promote
social distancing and to preserve patient
and staff safety among OTPs. In March
2020, SAMHSA published flexibilities
in the provision of unsupervised doses
of methadone and the use of telehealth
in initiating buprenorphine.4 These
flexibilities represented the first
substantial change to OTP treatment and
medication delivery standards in over
20 years. A growing body of research
has demonstrated that these flexibilities
facilitate access to treatment and
eliminate criteria that promote stigma
and discourage people from accessing
care from OTPs.
This proposed rule not only makes
these flexibilities permanent, but also
updates standards to reflect an
accreditation and treatment
environment that has evolved since part
8 went into effect in 2001. Accordingly,
the Department is proposing to update
part 8 to: promote practitioner
autonomy; remove stigmatizing or
outdated language; create a patientcentered perspective; and reduce
barriers to receiving care. These
elements have been identified in the
literature and in feedback as being
essential to promoting effective
treatment in OTPs.5 6 7
To this end, the definition of a
qualifying practitioner has been
4 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.
5 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.
6 Kleinman MB, Felton JW, Johnson A, Magidson
JF. ‘‘I have to be around people that are doing what
I’m doing’’: The importance of expanding the peer
recovery coach role in treatment of opioid use
disorder in the face of COVID–19 health disparities.
J Subst Abuse Treat. 2021 Mar;122:108182. doi:
10.1016/j.jsat.2020.108182. Epub 2020 Oct 21.
PMID: 33160763; PMCID: PMC7577312.
7 Suen LW, Castellanos S, Joshi N, Satterwhite S,
Knight KR. ‘‘The idea is to help people achieve
greater success and liberty’’: A qualitative study of
expanded methadone take-home access in opioid
use disorder treatment. Subst Abus.
2022;43(1):1143–1150. doi: 10.1080/
08897077.2022.2060438. PMID: 35499469.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
expanded to include a provider who is
appropriately licensed by the state to
prescribe (including dispense) covered
medications and who possesses a
waiver under 21 U.S.C. 823(g)(2).
Admission criteria have been updated to
remove significant barriers to entry,
such as the one-year requirement for
opioid use disorder (OUD),8 while also
defining the scope and purpose of the
‘initial’ and ‘periodic’ medical
examinations. The proposed rule also
includes new definitions to expand
access to evidence-based practices such
as split dosing, telehealth and harm
reduction activities. Further to this,
outdated terms such as ‘detoxification’
have been revised to remove
stigmatizing language.
The Department promotes practitioner
autonomy and individualized care by
proposing to revise the provision
containing the criteria for unsupervised
doses of methadone. This includes
removal of consideration of the length of
time an individual has been in
treatment, as well as rigid reliance on
toxicology testing results that
demonstrate complete and sustained
abstinence from all substances prone to
misuse. Based on the clinical judgment
of the treating provider, patients may be
eligible for unsupervised, take home
doses of methadone upon entry into
treatment. This recognizes the
importance of the practitioner-patient
relationship, and is consistent with
modern treatment standards. It also
allows for greater flexibility in creating
plans of care that promote recovery
activities such as employment, while
also eliminating the barrier of frequent
visits for individuals without access to
reliable transportation.9
Accreditation and certification
standards have been reviewed to codify
the use of online/electronic forms, to
eliminate types of certification that are
no longer in use, and to update existing
types of certification in a manner that
reflects established practice. Part 8 has
also been updated to facilitate
information sharing between
Accreditation Bodies and SAMHSA,
particularly in those circumstances
where there have been changes or
violations in accreditation. The
proposed rule also clarifies
administrative issues pertaining to
8 See
42 CFR 8.12(e)(1).
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.
9 Ware
PO 00000
Frm 00003
Fmt 4701
Sfmt 4702
77331
mobile medication units and interim
treatment.
The proposed changes seek to make
treatment in OTPs more accessible to
patients, easier to deliver for providers
and supportive of evidence-based and
patient-centered care. In proposing
these changes, SAMHSA has relied on
published evidence, stakeholder
feedback and the need to expand access
to care in the face of a growing overdose
epidemic, exacerbated by the COVID–19
PHE.10 This is brought further into focus
by the HHS declaration of a public
health emergency for the opioid crisis
which has been regularly renewed since
2017.11 The proposed changes are
expansive but are focused on
permanently implementing existing
flexibilities and updating practices. In
this way, SAMHSA believes that much
of what is proposed in the rule will not
represent a significant burden for OTPs
and, in fact, will offer many benefits to
providers and patients. The proposed
rule, therefore, supports OTPs in their
on-going provision of equitable and
evidence-based care to often
marginalized patients with OUD. The
proposed rule also is consistent with the
HHS Overdose Prevention Strategy
which calls for increasing access to and
the uptake of evidence-based treatments
for substance use disorders.12
B. Effective and Compliance Dates
The proposed effective date of a final
rule would be 60 days after publication
of the final rule and the compliance date
would be 6 months after the effective
date. Entities subject to the final rule
would have until the compliance date to
achieve compliance with this rule.
C. Summary of Major Proposals
The Department proposes the
following changes to 42 CFR part 8 that
revise, delete, replace, or add sections.
This section summarizes major
proposals in this NPRM. Additional
proposed revisions are not listed here
because they are not considered
major.13 All proposed changes are
discussed in detail in section III of this
NPRM:
10 Tanz LJ, Dinwiddie AT, Snodgrass S,
O’Donnell J, Mattson CL, Davis NL. A qualitative
assessment of circumstances surrounding drug
overdose deaths during the early stages of the
COVID–19 pandemic. SUDORS Data Brief, No 2.
Atlanta, GA: Centers for Disease Control and
Prevention, U.S. Department of Health and Human
Services; 2022.
11 See https://www.phe.gov/emergency/news/
healthactions/phe/Pages/default.aspx.
12 See https://www.hhs.gov/overdose-prevention/.
13 Generally, the proposals not listed make
wording changes, not substantive changes. These
proposals are reviewable in the regulatory text.
E:\FR\FM\16DEP3.SGM
16DEP3
77332
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
1. Heading.
The heading of part 8 has been
changed from Medication Assisted
Treatment for Opioid Use Disorders to
Medications for the Treatment of Opioid
Use Disorder to reflect currently
accepted medical terminology and to
remove language that is widely viewed
to be stigmatizing.
2. Subpart A.
Subpart A currently addresses
accreditation and includes steps that
accreditation bodies must follow to
obtain approval to accredit OTPs. It also
sets forth accreditation bodies’
responsibilities, including the use of
accreditation elements, during
accreditation surveys. In the proposed
rule, these specifications are relocated
to subpart B, which still would include
Certification of Opioid Treatment
Programs. The proposed rule limits
subpart A to the preamble and
definitions.
3. Section 8.1—Scope.
Revised § 8.1 to reflect modern
medical terminology, to detail updated
acronyms, and for clarity. Of note, the
term medication assisted treatment
(MAT) has been updated to MOUD, and
the term treatment program has been
changed to opioid treatment program
throughout the proposed rule.
lotter on DSK11XQN23PROD with PROPOSALS3
4. Section 8.2—Definitions.
Revised § 8.2 to add and update
definitions. Added definitions include:
care plan; harm reduction;
individualized dose; long-term care
facility; recovery support services; split
dosing; and telehealth. Existing
definitions updated include:
comprehensive treatment; medication
for opioid use disorder; and
practitioner. The term detoxification
treatment is removed and replaced with
withdrawal management.
5. Section 8.3—Application For
Approval as an Accreditation Body.
Added details of policies and
procedures expected of accreditation
bodies, particularly that accreditation
bodies shall include staff physician(s)
with experience in treating OUD with
MOUD in their survey team. A
correction has been made to the email
address to which the accreditation
application is submitted. The current
rule calls for the accreditation bodies’
training policies to be provided as part
of their application process.
Furthermore, this regulation would be
updated to ensure that accreditation
bodies provide training policies
specifically related to training of survey
team members. In addition to state or
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
territorial governments, the proposed
rule also provides for Indian Tribes to
apply for approval as an accreditation
body.
6. Section 8.4—Accreditation Body
Responsibilities.
Amended to clarify expectations for
cooperation of accreditation bodies with
SAMHSA’s oversight. These include
steps to be taken by accreditation bodies
in response to OTPs that are found to
not be complying with accreditation or
certification standards, such as follow
up on corrective measures and
confirmation of timely corrections. Time
frames are also established for
submission of survey reports. The
proposed rule adds a requirement that
all records of accreditation activities be
made available to SAMHSA upon
request. Current requirements regarding
accreditation body follow up on
complaints are maintained, but the
proposed rule adds a requirement that
accreditation bodies notify SAMHSA of
all aspects of a complaint response
within 5 days of receipt. The current
rule requiring surveyors to recuse
themselves from surveys due to conflict
of interest is amended to clarify that
such conflicts must be documented by
the accreditation body and made
available to SAMHSA.
7. Section 8.11—Opioid Treatment
Program Certification.
This section is amended to update
categories of certification, to clarify
SAMHSA’s expectation that OTPs
maintain certification, and to establish
procedures for OTPs whose certification
has lapsed. Current terms for the
extension of certification are amended
to clarify the circumstances in which an
extension could be requested, and the
means of requesting an extension are
defined in the proposed rule. The
proposed rule also updates the
certification application process to
reflect the shift from paper applications
to electronic submission, and the email
address for submission of supporting
documents is corrected.
The proposed rule removes
‘‘transitional certification’’ which
expired as a category of certification in
2003. The wording of ‘‘provisional
certification’’ is amended to clarify that
it is a category of certification available
only to new programs that have not
been previously certified, and a new
category of ‘‘conditional certification’’
has been added for OTPs that have
received a one-year conditional
accreditation status from an accrediting
body—an organization that has been
approved by the Secretary of HHS to
accredit OTPs—in order for operations
PO 00000
Frm 00004
Fmt 4701
Sfmt 4702
to continue or resume as the OTP takes
steps needed to achieve permanent
certification. The criteria for granting
certification extensions outside of
routine certification renewals has been
expanded to address extensions needed
under extraordinary circumstances. The
grammar used in describing procedures
for requesting an extension was revised.
The applicability of Health Insurance
Portability and Accountability Act
(HIPAA) privacy protections have been
explained, along with clarification that
changes in the status of the program
sponsor or medical director must be
submitted to SAMHSA in writing. The
chapter of the Controlled Substances
Act with which OTPs are expected to
comply has been added; the chapter
number is not included in the current
version of the rule.
The conditions for approval of interim
treatment have been amended to
increase the duration of interim
treatment from 120 days to 180 days,
with the stipulation that individuals
shall not be discharged without the
approval of an OTP practitioner while
awaiting transfer to a comprehensive
treatment program. A reference to
section 1923 of the Public Health
Service Act (21 U.S.C. 300x–23) is
removed. The proposed rule also shifts
the need to seek approval from the
‘chief public health officer’ of the state
in which the OTP operates to the State
Opioid Treatment Authority in the state
in which the OTP operates.
The services that can be provided in
medication units have been clarified to
explicitly allow the full range of OTP
services, based on space and privacy
available in the medication unit.
8. Section 8.12—Federal Opioid Use
Disorder Treatment Standards.
Revisions of treatment standards
incorporated in this section aim to
improve access to treatment, improve
patient satisfaction and engagement in
services and support use of clinical
judgment in decision-making. In several
instances, stigmatizing language such as
‘‘legitimate treatment use’’ of controlled
substances, has been removed and
patient-centered language is added.
The paragraph on staff credentials is
amended to expand the definition of
‘‘qualifying practitioners’’ to a
‘‘physician, physician assistant, nurse
practitioner, clinical nurse specialist,
certified registered nurse anesthetist, or
certified nurse midwife who is
appropriately licensed by a State to
prescribe covered medications and who
possesses a waiver under 21 U.S.C.
823(g)(2).’’ The expectation that all
licensed and credentialed staff maintain
E:\FR\FM\16DEP3.SGM
16DEP3
lotter on DSK11XQN23PROD with PROPOSALS3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
licensure and/or certification has been
added.
Criteria for admission to treatment
removes reference to the Diagnostic and
Statistical Manual of Mental Disorders
(DSM) IV and eliminates the
requirement for a one-year history of
OUD. The proposed rule instead
specifies that the individual should
either: meet diagnostic criteria for active
moderate to severe OUD; that the
individual may be in OUD remission; or
at high risk for recurrence or overdose.
The section is amended to assure that
the basis for the admission decision is
documented in the patient’s record. In
recognition of the use of telehealth and
its limitation in obtaining physical
signatures, the requirement to obtain
written patient consent to treatment is
removed. Consent may be provided
verbally or electronically, and
documented as such. The requirement
that individuals under age 18 have two
documented unsuccessful attempts at
short term withdrawal management
(‘‘detoxification’’) or drug free treatment
is also amended to allow consent of a
parent, legal guardian, or responsible
adult. Further to this, the rule requiring
a 1-year history of OUD for people
recently released from penal
institutions, pregnant patients or
previously enrolled individuals has
been removed.
Throughout the document,
‘‘detoxification’’ and the corresponding
definition and standards for short-and
long-term detoxification treatment have
been removed. ‘‘Withdrawal
management’’ and terms for tapering
from MOUD are added on behalf of
individuals who seek this approach or
who elect or need to reduce and/or
discontinue MOUD.
The ‘‘Required services’’ paragraph is
revised to incorporate patient-centered
language, establish flexible terminology,
promote use of clinical judgment, and
clarify SAMHSA’s expectations of
OTPs. The proposed rule creates the
requirement that services be available
that meet patient needs, and ‘‘shared
decision making’’ is added as the
method to be used in developing care
plans.
The paragraph describing the initial
medical examination has been amended
to clarify the terms ‘‘screening’’ medical
exam and ‘‘comprehensive
examination’’, while also expanding the
qualifications of practitioners able to
complete such examinations. These
include practitioners outside of the OTP
(with limitations and specific
instructions). The proposed rule also
creates criteria for lab testing conducted
prior to a screening medical exam, as
well as a permissible timeframe. The
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
use of telehealth in undertaking the
screening medical exam and initiation
of MOUD has also been addressed in the
proposed rule. Additionally, the
paragraph on special services for
pregnant people is amended to specify
that confirmation of pregnancy is
required for priority treatment
admissions. The option to use split
dosing for patients is also added.
The components of initial and
periodic medical examinations have
been expanded in the proposed rule to
incorporate assessment of behavioral
health, risk of self-harm or harm to
others, and to specify time frames for
completion of the care plan. Areas of
psychosocial assessment are amended
so as to assure information is gathered
on the context of the patient’s whole life
such as their mental health, housing,
recovery support and harm reduction
resources. Additionally, patientcentered language has been added, such
as ‘‘services a patient needs and wishes
to pursue’’.
The proposed rule expands the
definition of ‘counseling services’ to
include psychoeducational services,
harm reduction and recovery-oriented
services, and counseling and linkage to
treatment for anyone with positive test
results on human immunodeficiency
virus (HIV), viral hepatitis, and other
sexually transmitted infection (STI)
panels, or from OTP-provided medical
examinations. Language about services
that must be provided directly or
through referral is revised to promote a
patient-centered approach to care that
does not make medication continuity
contingent upon involvement in
counseling services but fosters shared
decision-making for all care plans.
The requirement that an OTP have a
formal documented agreement with
outside agencies is amended to remove
the word ‘‘formal’’; the proposed rule
calls for a ‘‘documented agreement’’ to
provide such services.
Language that addresses drug testing
services has been amended to remove
stigmatizing phrases, such as ‘‘drug
abuse’’, and to remove content on shortterm withdrawal management
(‘‘detoxification’’). Further to this, the
requirement to use drug tests that have
received the FDA’s marketing
authorization was added.
Rules that address recordkeeping and
efforts to avoid simultaneous enrollment
in multiple OTPs are amended to be
more declarative, such as changing the
word ‘‘review’’ to ‘‘determine’’ whether
or not a patient is enrolled in another
OTP, and documenting review efforts in
the patient’s record to demonstrate the
good faith efforts made. The proposed
rule also expands the circumstances in
PO 00000
Frm 00005
Fmt 4701
Sfmt 4702
77333
which a patient may obtain treatment at
another OTP to include instances when
there is an inability to access care at the
OTP of record.
Specification of disciplines
authorized to administer or dispense
MOUD is removed from the rule.
LAAM, also known as
Levacetylmethadol, is removed from the
list of treatment medications because it
is no longer available, and other
medications approved since prior
revisions to this rule were added. The
regulation of an initial dose of
methadone remains at 30mg, not to
exceed 40mg on the first day, with the
incorporation of a provision for higher
doses if clinically indicated and
documented in the patient’s record. The
rule to ensure documentation of any
significant deviation from FDAapproved labeling has been maintained
in the proposed rule, while redundant
language was removed.
Rules on the provision of
unsupervised (or take home) doses of
methadone are substantially amended to
incorporate flexibilities issued in
response to the COVID–19 pandemic.
Stigmatizing language is removed, and
the criteria for decision-making is
reframed to promote use of clinical
judgement and patient-centered care. In
general, the revised criteria allow up to
7 days of take home doses during the
first 14 days of treatment, up to 14 take
home doses from 15 days of treatment
and up to 28 take home doses from 31
days in treatment. The requirement that
OTPs maintain procedures to protect
take homes from theft and diversion was
continued, and patient education on
safe transport and storage of take home
doses is added, including
documentation of the provision of this
education in the patient’s clinical
record.
Consistent with the conditions for
approval of interim treatment, the
proposed rule extends the potential
duration of interim treatment from 120
days to 180 days. It also clarifies the
circumstances in which interim
treatment may apply and maintains
priority access to comprehensive
services for pregnant individuals. The
proposed rule removes the requirement
for observation of all daily doses during
interim treatment. It clarifies the
expectation that crisis services and
information pertaining to locally
available, community-based resources
for ancillary services be made available
to individual patients in interim
treatment. A requirement of a plan for
continuing treatment beyond 180 days
of interim services was added to the
proposed rule.
E:\FR\FM\16DEP3.SGM
16DEP3
77334
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
9. Section 8.13—Revocation of
Accreditation and Accreditation Body
Approval.
Changes in this section were limited
to referring to an OTP as a ‘‘program’’
instead of a ‘‘facility’’.
10. Section 8.14—Suspension or
Revocation of Certification.
This section refines steps SAMHSA
may take when immediate action is
necessary to protect public health or
safety.
11. Subpart D—Procedures for Review
of Suspension or Proposed Revocation
of OTP Certification, and of Adverse
Action Regarding Withdrawal of
Approval of an Accreditation Body.
Language referencing ‘‘treatment
program’’ in this section was changed to
‘‘OTP’’ for document consistency.
12. Subpart F—Authorization To
Increase Patient Limit to 275 Patients.
This subpart has been amended to
change the format from the prior
Question-and-Answer style to a
standard format.
13. Section 8.610—Practitioner
Eligibility Requirements for a 3-Year
275-Patient Limit.
Modernized language to refer to
MOUD and to remove stigmatizing
language that referred to ‘legitimate
medications’. The proposed rule also
clarified that the 275-patient waiver is
limited to three years in duration,
requiring renewal.
lotter on DSK11XQN23PROD with PROPOSALS3
14. Section 8.635—What are the
reporting requirements for practitioners
whose 275 request for patient limit is
approved?
The proposed rule removes reporting
requirements for practitioners approved
to treat up to 275 patients, eliminating
§ 8.635 in its entirety.
Background and Need for Proposed
Rule
As of June 2022 there are over 1,920
OTPs in the United States, providing
care to over 650,000 patients. These are
the only settings within which
methadone, a schedule II opioid
receptor agonist, can be legally provided
to people with OUD outside the context
of hospital admission or certain other
special circumstances.14
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.
14 See
21 CFR 1306.07.
VerDate Sep<11>2014
22:09 Dec 15, 2022
Jkt 259001
Currently, these include methadone and
buprenorphine, a schedule III partial
opioid receptor agonist. Other
pharmacotherapies, such as naltrexone,
may be provided but are not subject to
regulations under part 8. For purposes
of certification, OTPs must also provide
adequate medical, counseling,
vocational, educational, and other
assessment and treatment services either
onsite or by referral to an outside agency
or practitioner.15 Buprenorphine can
also be dispensed (including by
prescribing) to treat OUD by eligible
practitioners with a waiver under 21
U.S.C. 823(g)(2) in settings outside of
OTPs given its different scheduling and
treatment under the Controlled
Substances Act.16
Practitioners treating OUD and the
OTPs in which they practice must
continuously adapt to evolving patterns
of drug misuse. Over the past 40 years,
this has been complicated by rapid
changes in prescribing practices, supply
chains and patterns of drug use. Indeed,
the early opioid epidemic of the 1990s
was characterized by an increased
supply of prescription opioids.17 By
2010, however, the U.S. began to see
rapid increases in overdose deaths
involving heroin 18 and then by 2013,
synthetic opioids other than
methadone—primarily illicitly
manufactured fentanyl—contributed to
a further rise in overdose-related
deaths.19 20
The isolation, anxiety and reduced
access to resources experienced by
many during the COVID–19 pandemic
15 Substance Abuse and Mental Health Services
Administration. (2015). Federal guidelines for
opioid treatment programs. HHS Publication No.
(SMA) PEP15–FEDGUIDEOTP. Rockville, MD:
Substance Abuse and Mental Health Services
Administration.
16 21 U.S.C. 823(g)(2); Substance Abuse and
Mental Health Services Administration.
Medications for Opioid Use Disorder. Treatment
Improvement Protocol (TIP) Series 63 Publication
No. PEP21–02–01–002. Rockville, MD: Substance
Abuse and Mental Health Services Administration,
2021.
17 Centers for Disease Control and Prevention
(CDC). Vital signs: overdoses of prescription opioid
pain relievers—United States, 1999–2008. MMWR
MorbMortal Wkly Rep. 2011 Nov 4; 60(43):1487–
1492.
18 Rudd RA, Paulozzi LJ, Bauer MJ, Burleson RW,
Carlson RE, Dao D, Davis JW, Dudek J, Eichler BA,
Fernandes JC, Fondario A. Increases in heroin
overdose deaths—28 states, 2010 to 2012.MMWR
MorbMortal Wkly Rep. 2014 Oct 3; 63(39):849.
19 Gladden RM, Martinez P, Seth P. Fentanyl law
enforcement submissions and increases in synthetic
opioid-involved overdose deaths—27 states, 2013–
2014. MMWR MorbMortal Wkly Rep. 2016; 65:837–
43.
20 O’Donnell JK, Gladden RM, Seth P. Trends in
deaths involving heroin and synthetic opioids
excluding methadone, and law enforcement drug
product reports, by census region—United States,
2006–2015. MMWR MorbMortal Wkly Rep. 2017;
66:897–903.
PO 00000
Frm 00006
Fmt 4701
Sfmt 4702
has exacerbated substance misuse and
overdose deaths. According to
provisional data from the Centers for
Disease Control and Prevention (CDC), a
predicted 107,375 Americans died from
a drug overdose in the 12-month period
ending in January 2022.21 Synthetic
opioids (primarily illicitly
manufactured fentanyl) appear to be the
principal driver of overdose deaths,
increasing 55 percent from 2019 to 2020
and further increasing 26 percent from
2020 to 2021.22 Overdose deaths
involving cocaine also increased by 22
percent from 2019 to 2020. These deaths
are likely linked to co-use or mixing (by
illicit producers) of cocaine with
illicitly manufactured fentanyl or
heroin.23 The rise in fentanyl use or
exposure, concurrent substance misuse,
as well as overdose deaths, necessitates
changes to part 8 that expand access to
care, and promote engagement in OTP
services, while also maintaining
oversight and accreditation activities.
Oversight and accreditation standards
are supported as a means of promoting
evidence-based care, while minimizing
diversion and also adverse patient
outcomes.
A. Regulatory Background
On January 17, 2001 (66 FR 4075), the
Department issued final regulations for
the use of opioid agonist medications
(referred to as narcotic drugs) in
treatment and withdrawal management
(referred to as detoxification) of OUD.
The final rule repealed the treatment
regulations enforced by the FDA, and
created a new regulatory system based
on an accreditation model. In addition,
the final rule shifted administrative
responsibility and oversight from the
FDA to SAMHSA. This rulemaking
initiative followed a study by the
Institute of Medicine (IOM) (now known
as the National Academy of Medicine)
and reflected recommendations by the
IOM and several other entities to
improve the treatment of OUD by
allowing for increased medical
judgment in the care of patients with
OUD. Since publication of the final rule
in 2001, it has been updated to include
new medications, such as
buprenorphine, while also updating or
adding new rules governing the
provision of such medications.
Between 1972 and 2001, Federal
regulatory oversight of OTPs was
21 Ahmad, F.B., Rossen, L.M., Sutton, P. (2021).
Provisional drug overdose death counts. National
Center for Health Statistics.
22 Wide-ranging online data for epidemiologic
research (WONDER). Atlanta, GA: CDC, National
Center for Health Statistics; 2022. Available at
https://wonder.cdc.gov.
23 Ibid.
E:\FR\FM\16DEP3.SGM
16DEP3
lotter on DSK11XQN23PROD with PROPOSALS3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
enforced by the FDA before
responsibility for oversight was
transferred to SAMHSA. Periodic
reviews, studies, and reports on the
Federal oversight system culminated
with the 1995 IOM Report entitled
Federal Regulation of Methadone
Treatment.24 The IOM report
recommended that the FDA 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 who intended
to dispense opioid agonist medications
in the treatment of OUD must first
obtain from SAMHSA, a certification
that the applicant is qualified under the
Secretary’s standards and will comply
with such standards. Eligibility for
certification depended upon the
applicant obtaining accreditation from a
private nonprofit entity, or from a State
agency, that had been approved by
SAMHSA to accredit OTPs.
Accreditation bodies were directed to
base accreditation decisions on a review
of an application for accreditation and
on surveys (onsite inspections)
conducted every three years by OUD
treatment experts. In addition,
accreditation bodies must apply specific
opioid treatment accreditation elements
that reflect ‘‘state-of-the-art’’ opioid
treatment guidelines. Further to this,
accreditation standards required that
OTPs have quality assurance systems
that consider patient outcomes.
The 2001 final regulations replaced
FDA ‘approval’ of programs, with direct
government inspection in accordance
with more detailed process-oriented
regulations. These process-oriented
regulations continue to prescribe many
aspects of oversight and treatment. To
this end, subpart B of the regulation
addresses accreditation and includes
steps that accreditation bodies must
follow to achieve approval to accredit
OTPs. It also sets forth the accreditation
bodies’ responsibilities, including the
24 For full text, see: https://
www.ncbi.nlm.nih.gov/books/NBK232108/.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
use of accreditation elements during
accreditation surveys. Subpart C
describes the sequence and
requirements for obtaining certification,
and addresses how and when programs
must apply for initial certification and
renewal of their certification. Subpart D
elucidates the procedures for review of
the withdrawal of approval of the
accreditation body or the suspension
and proposed revocation of an OTP
certification. Subpart F, added in 2016,
describes criteria for increasing the
patient limit for those meeting Federal
requirements to prescribe
buprenorphine to 275.25
In 2001 there were close to 900 OTPs,
but that number has grown to over 1900
by 2022.26 Over this period of time, the
incidence of fentanyl misuse has
increased, escalating with the onset of
the COVID–19 public health emergency
in early 2020. To protect the public’s
health and reduce the risk of COVID–19
infection among patients and providers,
SAMHSA issued flexibilities in the
provision of unsupervised doses of
methadone and also initiation of
buprenorphine via telehealth, that
allowed for continued treatment of OUD
with reduced direct patient contact.
Each of these flexibilities represented a
significant change to treatment
standards, and are discussed in detail
below.
Flexibility for Methadone Medication
Take Homes in Opioid Treatment
Programs
Among the existing standards for
medication administration and
dispensing of methadone are limitations
on unsupervised or ‘‘take home’’ use.
These prior standards were established
early in the history of methadone as a
medication for OUD, and the criteria for
determining whether a patient may be
allowed take homes were restrictive,
requiring daily visits to the OTP for
extended periods of time, and
adherence to strict measures of
sustained stability as described in 42
CFR part 8.27 These criteria can pose
disruption to employment and daily
activities for patients, and several of the
criteria reflect outdated biases that
promote stigma and discourage people
from engaging in care in OTPs.
In March 2020, as a result of the
pandemic, SAMHSA issued exemptions
that allowed state regulatory authorities
to request blanket exceptions to allow
25 See https://www.federalregister.gov/
documents/2016/07/08/2016-16120/medicationassisted-treatment-for-opioid-use-disorders.
26 SAMHSA treatment locator. See https://
dpt2.samhsa.gov/treatment/directory.aspx.
27 https://www.ecfr.gov/current/title-42/chapter-I/
subchapter-A/part-8?toc=1.
PO 00000
Frm 00007
Fmt 4701
Sfmt 4702
77335
patients to take home more doses of
methadone; 43 states and the District of
Columbia did so.28 With this flexibility,
SAMHSA allowed OTPs to dispense 28
days of ‘‘take home’’ methadone doses
to ‘‘stable’’ patients for the treatment of
OUD, and up to 14 doses of ‘‘take
home’’ methadone for ‘‘less stable’’
patients ‘‘who the OTP believes can
safely handle this level of take home
medication.’’ 29 Although the duration
of this flexibility was not initially
specified, a SAMHSA FAQ published in
April 2020, indicated that the flexibility
was tied with the duration of ‘‘the
current national health emergency
. . . .’’ 30
The intention of the methadone take
home flexibility was to reduce the risk
of COVID–19 infection among patients
and providers. Beyond this, the
flexibility promotes individualized care
that considers patient characteristics
and program involvement beyond time
in treatment. By reducing the burden on
patients to visit the OTP daily, this
flexibility could reduce stigma for those
seeking treatment, while also providing
more equitable access to care as
telemedicine in OTPs is expanded. It
also allows those who reside far from an
OTP or who lack access to reliable
transportation to receive treatment,
while also being able to gain or maintain
employment, care for loved ones and
engage in other required activities of
daily living.
The methadone take home flexibility
has been met with widespread support
among patients,31 OTPs,32 and state
authorities.33 Patients reported that
increased take home doses of
methadone left them feeling more
respected as responsible individuals.31
In a recent meeting, state authorities
reported that the flexibilities were
appreciated by patients and OTPs alike,
28 HHS Guidance for Opioid Treatment Programs.
https://www.samhsa.gov/sites/default/files/otpguidance-20200316.pdf.
29 See https://www.samhsa.gov/sites/default/files/
otp-guidance-20200316.pdf.
30 See https://www.samhsa.gov/sites/default/files/
faqs-for-oud-prescribing-and-dispensing.pdf.
31 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.
32 Joseph G, Torres-Lockhart K, Stein MR, Mund
PA, Nahvi S. Reimagining patient-centered care in
opioid treatment programs: Lessons from the Bronx
during COVID–19. J Subst Abuse Treat. 2021
Mar;122:108219. doi: 10.1016/j.jsat.2020.108219.
Epub 2020 Dec 3. PMID: 33353790; PMCID:
PMC7833302.
33 ‘‘To Save Lives From Opioid Overdose Deaths,
Bring Methadone Into Mainstream Medicine’’,
Health Affairs Forefront, May 27, 2022.
E:\FR\FM\16DEP3.SGM
16DEP3
77336
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS3
with no significant change in rates of
diversion seen since the COVID–19 PHE
was declared. Indeed, analysis of the
relevant data indicates that the actual
level of misuse, diversion or harm from
methadone is more likely to occur when
it is prescribed for pain as opposed to
OUD, and that the rate of diversion is
lower than that of oxycodone or
hydrocodone.34 Additionally, a recent
survey found that diversion of
methadone is low among patients
receiving take home doses under the
COVID–19 PHE flexibility.35 36 Further
to this, analysis of data on fatal
overdoses from January 2019 to August
2021 demonstrated that this flexibility
did not lead to more deaths involving
methadone.37
Recognizing the importance of this
flexibility, SAMHSA released guidance
on November 18, 2021, that extended
the methadone take home flexibility for
one year past the end of COVID PHE.
This was to accommodate the rule
making process that proposes to make
this flexibility permanent. In this
proposed rule, SAMHSA has reviewed
and updated criteria used to determine
eligibility for take home doses of
methadone, while also promoting
shared decision making that is
supported by availability of
unsupervised doses of methadone from
entry into treatment. Individuals
receiving take home doses of methadone
are supported through individually
tailored telehealth visits to practitioners,
counselors and other services as
indicated. Further to this, the proposed
changes highlight practitioner autonomy
in determining eligibility for
unsupervised doses of methadone. This
is a significant change to treatment
standards, but it is grounded in
evidence that demonstrates the safety
34 National Institute on Drug Abuse (NIDA). 2018,
June. Medications to Treat Opioid Use Disorder.
Retrieved from https://irp.drugabuse.gov/wpcontent/uploads/2019/12/NIDA-Medications-totreat-opioid-use-disorder_2018.pdf.
35 Figgatt, MC, Salazar Z, Day E, Vincent L,
Dasgupta N. Take-home dosing experiences among
persons receiving methadone maintenance
treatment during COVID–19, Journal of Substance
Abuse Treatment, Volume 123, 2021, https://
doi.org/10.1016/j.jsat.2021.108276.
36 Dooling, B.C.E. & Stanley, L.E. (2021).
Unsupervised use of opioid treatment medications:
Report II of the extending pandemic flexibilities for
opioid use disorder treatment project. GW
Regulatory Studies Center. https://
regulatorystudies.columbian.gwu.edu/
unsupervised-use-opioid-treatment-medications.
37 Jones, C. M., Compton, W. M., Han, B.,
Baldwin, G., & Volkow, N. D. (2022). MethadoneInvolved 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.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
and efficacy of promoting patient and
provider autonomy.
The Opioid Treatment Program
Flexibility To Prescribe MOUD via
Telehealth Without an Initial In-Person
Physical Evaluation
Telehealth is a mode of service
delivery that has been used in clinical
settings for over 60 years and
empirically studied for just over 20
years. 38 39 40 Between 2016 and 2019,
use of telehealth, in general, doubled
from 14 to 28 percent,41 while substance
use disorder (SUD) treatment, offered
through telehealth over the same period,
increased from 13.5 to 17.4 percent.42
This trend has rapidly increased
between 2019 and 2021, due to the
COVID–19 pandemic.43
The pandemic spurred use of
telemedicine for the treatment of OUD
using buprenorphine, a schedule III
partial opioid receptor agonist. Prior to
buprenorphine’s development, the only
opioid agonist that could be used to
treat OUD was methadone dispensed
through OTPs. Methadone has a
relatively complicated pharmacological
profile, necessitating closer observation
of new patients to ensure that initial
doses do not exceed an individual’s
tolerance for the medication. The Drug
Addiction Treatment Act of 2000
(DATA 2000) allowed practitioners to
treat OUD outside of OTPs using
buprenorphine, generally with an initial
in-person medical evaluation before
prescribing.
On March 16, 2020, the Secretary of
HHS, with the concurrence of the
Acting DEA Administrator, designated
that the telemedicine exception under
21 U.S.C. 802(54)(D), applied to all
38 Bashshur, R.L., Shannon, G.W., Bashshur, N., &
Yellowlees, P.M. (2016). The empirical evidence for
telemedicine interventions in mental disorders.
Telemedicine and e-Health, 22(2), 87–113.
39 Lustig, T. (2012). The role of telehealth in an
evolving health care environment: Workshop
summary. National Academies Press.
40 Mace, S., Boccanelli, A., & Dormond, M. (2018).
The use of telehealth within behavioral health
settings: Utilization, opportunities, and challenges.
University of Michigan School of Public Health,
Behavioral Health Workforce Research Center.
41 American Medical Association (2019).
Telehealth implementation playbook. Digital Health
Implementation Playbook Series. https://www.amaassn.org/system/files/2020-04/ama-telehealth
implementation-playbook.pdf.
42 Uscher-Pines, L., Cantor, J., Huskamp, H.A.,
Mehrotra, A., Busch, A., & Barnett, M. (2020).
Adoption of telemedicine services by substance
abuse treatment facilities in the U.S. Journal of
Substance Abuse Treatment, 117, 108060.
43 Melamed OC, deRuiter WK, Buckley L, Selby
P. Coronavirus Disease 2019 and the Impact on
Substance Use Disorder Treatments. Psychiatr Clin
North Am. 2022 Mar;45(1):95–107. doi: 10.1016/
j.psc.2021.11.006. Epub 2021 Nov 12. PMID:
35219445; PMCID: PMC8585604.
PO 00000
Frm 00008
Fmt 4701
Sfmt 4702
schedule II–V controlled substances.44
Accordingly, DEA-registered, DATAWaived practitioners may issue
buprenorphine prescriptions through
telemedicine to new patients for whom
they have not conducted an in-person
medical evaluation, provided certain
conditions are met during the COVID–
19 public health emergency.
On March 25, 2020, the DEA also
granted a ‘‘temporary exception’’ to its
regulations that allows practitioners to
prescribe controlled medications in
states in which they are not registered,
if the practitioner is registered with the
DEA in at least one state and is
authorized by both the state where the
practitioner is registered with DEA and
the state where the dispensing occurs.45
According to the DEA, practitioners may
utilize this temporary exception via inperson prescribing or prescribing via
telemedicine. The DEA also specified
that this exception is granted through
‘‘the duration of the COVID–19 public
health emergency as declared by the
Secretary of Health and Human
Services.’’ 46
Building upon this, SAMHSA
implemented OTP regulatory
flexibilities designed to help address the
impact of the COVID–19 pandemic on
OTPs and their patients.47 In April
2020, SAMHSA exempted OTPs from
the requirement to perform an in-person
physical evaluation (under 42 CFR
8.12(f)(2)) for any patient who will be
treated by the OTP with buprenorphine
if a program physician, primary care
physician, or an authorized healthcare
professional under the supervision of a
program physician, determines that an
adequate evaluation of the patient can
be accomplished via telehealth. The
duration of this exemption was
specifically tied with the ‘‘period of the
national emergency declared in
response to the COVID–19 pandemic’’,48
and the exemption did not include
44 See https://www.deadiversion.usdoj.gov/
coronavirus.html.
45 See Exception to Separate Registration
Requirements Across State Lines (DEA067), https://
www.deadiversion.usdoj.gov/GDP/(DEA-DC018)(DEA067)%20DEA%20
state%20reciprocity%20(final)(Signed).pdf.
46 With respect to methadone delivery, during the
COVID–19 public health emergency, the DEA has
also authorized employees of OTPs to personally
deliver methadone to patients who otherwise
cannot travel to the OTP, and has issued a waiver
to permit law enforcement and National Guard
personnel to deliver methadone directly to patients
of OTPs. See https://www.deadiversion.usdoj.gov/
faq/coronavirus_faq.htm#NTP_FAQ.
47 OTPs are authorized to dispense narcotic
maintenance and detoxification medication under
21 U.S.C. 823(g)(1) and regulated under 42 CFR part
8.
48 See https://www.samhsa.gov/sites/default/files/
faqs-for-oud-prescribing-and-dispensing.pdf.
E:\FR\FM\16DEP3.SGM
16DEP3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS3
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,49 and that among
those requiring treatment with
buprenorphine, there are high levels of
satisfaction with the use of telehealth
services.50 Additionally, there are no
significant differences between
telehealth and in-person buprenorphine
induction in the rate of continued
substance use, retention in treatment or
engagement in services.38 51 Research
also shows that there is no significant
difference in client and provider ratings
of therapeutic alliance when using
telehealth technology platforms.39
In the face of an escalating overdose
crisis and an increasing need to reach
remote and underserved communities,
making the buprenorphine telehealth
flexibility permanent is of paramount
importance. The proposed rule makes
permanent criteria of initiation of
buprenorphine via audio-only or audiovisual telehealth technology if an OTP
physician, primary care physician, or an
authorized healthcare professional
under the supervision of a program
physician, determines that an adequate
evaluation of the patient can be
accomplished via telehealth.
SAMHSA believes that evidence
underlying the initiation of
buprenorphine using telehealth
translates, to some degree, to the
treatment of OUD with methadone, and
warrants expanding access to
methadone therapy by applying some of
the buprenorphine in-person
examination flexibilities to treatment
with methadone in OTPs.52 The
proposed rule allows for the use of
audio-visual telehealth for any new
patient who will be treated by the OTP
49 Guille, C., Simpson, A.N., Douglas, E., Boyars,
L., Cristaldi, K., McElligott, J., Johnson, D., & Brady,
K. (2020). Treatment of opioid use disorder in
pregnant women via telemedicine: A
nonrandomized controlled trial. JAMA Network
Open, 3(1), e1920177–e1920177.
50 King, V.L., Brooner, R. K., Peirce, J.M.,
Kolodner, K., & Kidorf, M.S. (2014). A randomized
trial of web-based videoconferencing for substance
abuse counseling. Journal of Substance Abuse
Treatment, 46(1), 36–42.
51 Vakkalanka, J.P., Lund, B. C., Ward, M.M.,
Arndt, S., Field, R.W., Charlton, M., & Carnahan,
R.M. (2022). Telehealth Utilization Is Associated
with Lower Risk of Discontinuation of
Buprenorphine: a Retrospective Cohort Study of US
Veterans. Journal of general internal medicine,
37(7), 1610–1618. https://doi.org/10.1007/s11606021-06969-1.
52 Chan B, Bougatsos C, Priest KC, McCarty D,
Grusing S, Chou R. Opioid treatment programs,
telemedicine and COVID–19: A scoping review.
Subst Abus. 2022;43(1):539–546. doi: 10.1080/
08897077.2021.1967836. Epub 2021 Sep 14. PMID:
34520702.
VerDate Sep<11>2014
22:49 Dec 15, 2022
Jkt 259001
with methadone if a program physician,
or an authorized healthcare professional
under the supervision of a program
physician, determines that an adequate
evaluation of the patient can be
accomplished via an audio-visual
telehealth platform. SAMHSA is not
extending this change to the use of
audio-only telehealth platforms in
assessing new patients who will be
treated with methadone because
methadone, in comparison to
buprenorphine, holds a higher risk
profile for sedation in patients
presenting with mild somnolence which
may be easier to identify through an
audio-visual telehealth platform. The
proposed rule is not applicable to, and
does not authorize, the prescription of
methadone pursuant to a telehealth
visit. Instead, this proposed change
applies to the ordering of methadone by
appropriately licensed OTP
practitioners and dispensed to the
individual patient by the OTP under
existing OTP procedures.
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 an audio-visual telehealth platforms
on the basis of their disability has an
equal opportunity to benefit from
treatment with MOUD. Similarly,
Federal civil rights laws that prohibit
discrimination on the basis of national
origin (including language ability),
require recipients to take reasonable
steps to provide meaningful access to
LEP individuals, which may require the
provision of a qualified interpreter and/
or translated material, such that they
have the opportunity benefit from
treatment with MOUD.
Expanding Access to Services
On June 28, 2021, the DEA introduced
requirements for OTPs to add a ‘‘mobile
component’’ to their existing
registration and waived any obligation
for an OTP mobile medication unit
complying with these requirements to
separately register at the remote
locations where it dispenses.53 On
53 See 86 FR 33861; https://
www.federalregister.gov/documents/2021/06/28/
PO 00000
Frm 00009
Fmt 4701
Sfmt 4702
77337
September 21, 2021, SAMHSA released
guidance on the establishment of mobile
and non-mobile medication units and
allowable services.54 While part 8
currently allows OTPs certified by
SAMHSA to establish medication units
(as defined under 42 CFR 8.2), the
proposed rule further defines mobile
units and clarifies potential services,
interventions and accreditation
processes.
Additionally, the proposed rule
defines harm reduction and promotes
expansion of harm reduction services to
OTP patients.55 The importance of this
has been highlighted during the COVID–
19 pandemic, principally with the CDC
and SAMHSA’s April 7, 2021, joint
announcement that Federal funding
could be used to purchase rapid
fentanyl test strips (FTS).56 This was
proposed in an effort to help curb the
dramatic spike in drug overdose deaths
largely driven by the use (both
intentional and unintentional) of potent
synthetic opioids, primarily illicitly
manufactured fentanyl. FTS can be used
to determine if drugs have been mixed
or cut with fentanyl, providing people
who use drugs and their communities
with important information about
fentanyl in the illicit drug supply so
they can take steps to reduce their risk
of overdose. Other important harm
reduction activities highlighted in the
proposed rule include: counseling on
preventing exposure to, and the
transmission of, HIV, viral hepatitis, and
STIs; providing access to services and
treatments for those with HIV, viral
hepatitis or an STI; provision of patientcentered harm reduction education; and
distribution of opioid overdose reversal
medications (e.g., naloxone).57
The need to facilitate access to
services has been highlighted during the
COVID–19 pandemic. This is
particularly important in the face of
increased exposure to fentanyl. Section
8.12(e)(1) of the proposed rule
eliminates the requirement that a person
must have had an addiction to opioids
for one year before admission to
treatment and receipt of OTP services,
and permits access to those: who meet
diagnostic criteria for a moderate to
severe OUD; individuals with active
2021-13519/registration-requirements-for-narcotictreatment-programs-with-mobile-components.
54 See https://www.samhsa.gov/medicationassisted-treatment/statutes-regulationsguidelines#mobile.
55 The proposed rule does not permit OTPs to
engage in any activities that would violate Federal,
State, or local law.
56 See https://www.cdc.gov/media/releases/2021/
p0407-Fentanyl-Test-Strips.html.
57 See https://www.samhsa.gov/blog/new-samhsaguide-highlights-hiv-prevention-treatment-peoplesubstance-use-andor-mental.
E:\FR\FM\16DEP3.SGM
16DEP3
77338
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS3
moderate to severe OUD, or OUD in
remission; or those individuals who are
at high risk for overdose or recurrence
of use. Admission to the OTP is
contingent upon appropriate informed
consent and education, as well as
appropriate documentation of consent
in the patient’s clinical record.
These activities are supported, in the
proposed rule, through defining a
practitioner (in § 8.2) as being ‘‘a
physician, physician assistant, nurse
practitioner, clinical nurse specialist,
certified registered nurse anesthetist, or
certified nurse midwife who is
appropriately licensed by a State to
prescribe covered medications and who
possesses a waiver under 21 U.S.C.
823(g)(2).’’ Further to this, the proposed
rule expands decision making capacity
of OTP practitioners to: admission of
patients; the provision of treatment
activities; and service provision. This is
supported by the use of telehealth,
described above, and involvement of
outside practitioners. Indeed, § 8.12(f)(2)
of the proposed rule allows for the
initial medical examination to be
completed by a practitioner external to
the OTP no more than seven days prior
to admission, provided that it is verified
by an OTP practitioner. This expands
access to OTP services and is consistent
with current medical practice.
In this way, the proposed rule draws
on evidence from the COVID–19
pandemic as well as over 20 years of
practice-based research. The proposed
rule makes permanent or expands upon
flexibilities initiated during the COVID–
19 PHE and recognizes the efficacy and
safety of creating a less restrictive and
patient-centered treatment environment.
Further to this, the evidence
demonstrates the positive impact of not
requiring frequent patient visits to the
OTP. This has been shown to promote
recovery behaviors, such as sustained
employment, as well as support those
individuals who live a long distance
from the OTP.58 The integration of
telehealth into the proposed rule further
supports this and allows OTPs
flexibility in initiating MOUD.
Section-by-Section Description of
Proposed Amendments to 42 CFR Part
8
Below, the Department describes the
proposals in this NPRM to amend 42
CFR part 8. The Department believes
that the proposed rule expands access to
evidence-based and patient-centered
58 Treitler, P.C., Bowden, C.F., Lloyd, J., Enich,
M., Nyaku, A.N., & Crystal, S. (2022). Perspectives
of opioid use disorder treatment providers during
COVID–19: Adapting to flexibilities and sustaining
reforms. Journal of substance abuse treatment, 132,
108514. https://doi.org/10.1016/j.jsat.2021.108514.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
care, limits use of stigmatizing language,
and promotes the practitioner-patient
relationship. These changes are in line
with evidence-based practice, and the
Department welcomes feedback on all
aspects of the proposed rule.
In particular, the Department is
interested in feedback on the proposal
to increase the allowable time for
interim treatment from 120 days to 180
days. This is intended to accommodate
OTPs and states as they address
important issues such as staff shortages.
It may also serve as a way of engaging
individuals in care. Such issues
underlie the need for this service
approach, and while SAMHSA is
working with other Federal and State
agencies to build workforce capacity,
the use of interim treatment adds to the
care continuum for people with OUD.
The Department also seeks feedback
on other paradigms of care promoted in
the proposed rule. Split-dosing and
delivery of services via telehealth are,
for example, evidence-based
interventions that promote patientcentered care. The Department proposes
to expand access to evidence-based
treatment through the addition of such
practices, and seeks guidance on the
proposed use of these interventions and
their integration into the practice
environment.
Also proposed are new criteria to
support decision making around take
home doses of methadone. The take
home flexibility issued at the start of the
COVID–19 pandemic demonstrated that
length of time in treatment, as well as
strict negative toxicology test results
were not central to positive outcomes.58
This is reflected in the proposed rule,
and feedback is solicited on the
proposed criteria, as well as the
schedule for providing unsupervised
doses of methadone.
The Department further requests
comment on all proposals described in
the following paragraphs of this NPRM.
In addition, the Department requests
comment on all aspects of the
Regulatory Impact Analysis, including
the assumptions and estimates about the
costs and benefits of the proposed
changes, and the alternatives the
Department considered when
developing the proposals in this NPRM.
The Department proposes the
following amendments to part 8:
A. Heading
The Department proposes to revise
the heading to Medications for the
Treatment of Opioid Use Disorder to
reflect current medical terminology and
to remove stigmatizing language. The
term ‘opioid use disorder’ more
precisely reflects the diagnosis for
PO 00000
Frm 00010
Fmt 4701
Sfmt 4702
which medications are indicated.
Further to this, the terms ‘maintenance’
and ‘detoxification’ reference outdated
terminology that has potentially
hindered adoption of evidence-based
treatments for OUD.59 The amended
heading reflects current medical
terminology and highlights that OUD is
a chronic, treatable condition.
B. Subpart A
Subpart A currently addresses
accreditation and includes steps that
accreditation bodies will follow to
achieve approval to accredit OTPs
under the new rules. It also sets forth
the accreditation bodies’
responsibilities, including the use of
accreditation elements during
accreditation surveys. In the proposed
rule, these specifications are relocated
to subpart B, which still includes
Certification of Opioid Treatment
Programs. In this way, subpart A is now
limited to the overview of part 8 and
definitions. This improves
categorization and provides clear flow
within the proposed rule.
C. Section 8.1—Scope
This section has been revised to
reflect modern medical terminology and
to detail updated acronyms.
Historically, pharmacological treatment
for opioid use disorder was referred to
as ‘‘medication assisted treatment’’
(MAT). There is an increasing
movement towards the more medically
accurate term ‘‘medication for opioid
use disorder’’ (MOUD) since this
precisely describes the medications that
are being provided, carries less stigma,
and aligns with treatment approaches to
all other health conditions. Further to
this, the term ‘MAT’ implies that these
medications are simply adjuncts to a
broader treatment strategy.60 In fact,
these medications are one critical
element of a comprehensive, long-term
treatment and recovery strategy.60 As
such, the acronym MAT has been
removed from the proposed rule and
replaced with MOUD throughout. The
proposed rule identifies other treatment
modalities, such as counseling, by their
individual component names, similar to
59 NIDA. 2021, November 29. Words Matter—
Terms to Use and Avoid When Talking About
Addiction. Retrieved from https://nida.nih.gov/
nidamed-medical-health-professionals/healthprofessions-education/words-matter-terms-to-useavoid-when-talking-about-addiction.
60 Substance Abuse and Mental Health Services
Administration. Medications for Opioid Use
Disorder. Treatment Improvement Protocol (TIP)
Series 63 Publication No. PEP21–02–01–002.
Rockville, MD: Substance Abuse and Mental Health
Services Administration, 2021.
E:\FR\FM\16DEP3.SGM
16DEP3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
the manner by which elements of other
chronic disease care are described.
E. Section 8.3—Application for
Approval as an Accreditation Body
D. Section 8.2—Definitions
This section adds details of policies
and procedures expected of
accreditation bodies for clarity and
completeness. In § 8.3(b) the email
address for submission of accreditation
body applications is updated. Changes
to § 8.3(b)(6) reflect the expectation that
physicians with experience in managing
MOUD are employed by accreditation
bodies to assure appropriate medical
standards of care are established and
included in review of OTPs. Further
amendments are incorporated to
promote communication between the
accreditation bodies and SAMHSA, and
to ensure that accreditation bodies focus
on OTP adherence to 42 CFR part 8.
Expectations about training provided for
survey team members are added to
promote consistency in OTP reviews
with Federal standards and to reduce
the risk of unnecessary and overly
burdensome accreditation activities.
Further to this, the proposed rule also
provides for Indian Tribes to apply for
approval as an accreditation body.
lotter on DSK11XQN23PROD with PROPOSALS3
In the 21 years since part 8 was first
published, definitions and paradigms of
care for OUD have changed. In
particular, treatment for OUD has
evolved from being prescriptive to
multimodal and patient-centered.61 This
reflects an understanding that OUD is a
chronic condition 62 and that to be
successful, treatment interventions
should be individualized and include
harm reduction and recovery support
services. Further to this, flexibilities
expanded under the COVID–19 PHE
demonstrated the safety of telehealth
interventions.63 Accordingly, telehealth
is defined in this section using a
standard definition. The proposed rule
updates other definitions to reflect
current evidence and practice in the
provision of care in OTPs. This is seen
in an expanded definition of
‘practitioner’. Patients have benefitted
for years from the care provided by
nurse practitioners (NPs) and physician
assistants (PAs) in OTPs, and the
proposed rule expands the definition of
practitioner to include a ‘‘physician,
physician assistant, nurse practitioner,
clinical nurse specialist, certified
registered nurse anesthetist, or certified
nurse midwife.’’ Finally, the proposed
rule removes the term ‘‘detoxification
treatment’’ and replaces it with
‘‘withdrawal management.’’ The term
detoxification is customarily called
medically supervised withdrawal
management to destigmatize the process
and more accurately reflect what
patients undergo, and healthcare
practitioners provide, in response to
withdrawal from a variety of substances
or medications to which physiologic
tolerance develops.64
61 Mark TL, Hinde J, Henretty K, Padwa H,
Treiman K. How Patient Centered Are Addiction
Treatment Intake Processes? J Addict Med. 2021
Apr 1;15(2):134–142. doi: 10.1097/
ADM.0000000000000714. PMID: 32826618.
62 Russell HA, Sanders M, Meyer JKV, Loomis E,
Mullaney T, Fiscella K. Increasing Access to
Medications for Opioid Use Disorder in Primary
Care: Removing the Training Requirement May Not
Be Enough. J Am Board Fam Med. 2021 NovDec;34(6):1212–1215. doi: 10.3122/
jabfm.2021.06.210209. PMID: 34772776.
63 Langabeer JR 2nd, Yatsco A, ChampagneLangabeer T. Telehealth sustains patient
engagement in OUD treatment during COVID–19. J
Subst Abuse Treat. 2021 Mar;122:108215. doi:
10.1016/j.jsat.2020.108215. Epub 2020 Nov 24.
PMID: 33248863; PMCID: PMC7685137.
64 Substance Abuse and Mental Health Services
Administration. Medications for Opioid Use
Disorder. Treatment Improvement Protocol (TIP)
Series 63 Publication No. PEP21–02–01–002.
Rockville, MD: Substance Abuse and Mental Health
Services Administration, 2021.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
F. Section 8.4—Accreditation Body
Responsibilities
SAMHSA is responsible for oversight
of the accreditation bodies. A thorough
review of its oversight procedures
resulted in several proposed changes to
improve processes, to assure
documentation of accreditation
decisions, and to establish steps to be
taken to assure OTP adherence to 42
CFR part 8. For example, making
records available to SAMHSA on
request is added to assure that SAMHSA
can review survey processes and
information, and confirm decisions of
survey outcomes. Other amendments,
such as accreditation body policies for
training survey team members, have
been added to address concerns
regarding inconsistent application of
accreditation standards and regulations.
The documentation and sharing of
information regarding conflict or
perceived conflict of interest has been
added to ensure any conflict of interest
and action taken by the accreditation
body is disclosed to SAMHSA.
G. Section 8.11—Opioid Treatment
Program Certification
The requirements for certification and
renewal have been in place since 2001.
Therefore, it is necessary to update
these as some certifications and
processes no longer apply. For example,
‘‘transitional certification’’ expired as a
category in May 2003. Other revisions
have been incorporated based on
PO 00000
Frm 00011
Fmt 4701
Sfmt 4702
77339
SAMHSA’s 20-years of experience in
OTP certification.
The category of ‘‘provisional’’
certification required clarification as to
when provisional certification is
available. Moreover, the current rule
only designates three-year certifications
for OTPs, whether the accreditation
survey resulted in a ‘‘full’’ (3-year) or
‘‘conditional’’ 1-year accreditation
status. The proposed rule establishes the
category of ‘‘conditional certification’’ to
allow an OTP granted a temporary oneyear accreditation to continue treatment
services while the OTP takes steps to
address issues identified during the
accreditation process. The current
regulation limits extension of
certification status to OTPs with
provisional certification only.
Circumstances related to the COVID–19
PHE necessitated expansion of
extensions for renewal of any category
of certification.
The expectation that OTPs comply
with HIPAA regulations when
applicable is added to emphasize rules
that govern practice that have come into
effect since 2001. Documentation of
change of sponsors or medical directors
is added to assure written records are
available, and a reference to the
applicable chapter of the Controlled
Substances Act for OTPs was added to
clarify the DEA regulations to which
OTPs must adhere.
Interim treatment means that on a
temporary basis, a patient may receive
services from an OTP, while awaiting
access to more comprehensive treatment
services. The extension of interim
treatment approval from 120 days to 180
days is intended to better accommodate
OTPs and states in addressing
underlying causes necessitating this
category of treatment, such as staff
shortages. This approach may also serve
to engage individuals with OUD who
otherwise may not seek care. Given the
significant mortality risk of illicit
fentanyl and data demonstrating
reductions in overdose death with
methadone treatment, interim services
add an opportunity for low-threshold
access to life-saving services. The
expectation that individuals enrolled in
interim treatment shall not be
discharged without the approval of an
OTP practitioner is to assure continuity
of and engagement in care for the
individual as an interim step to a
comprehensive treatment program
where additional services are available.
The reference to section 1923 of the
Public Health Service Act (PHSA) (42
U.S.C. 300x–23) is removed because it
does not specifically pertain to time in
interim treatment. The proposed rule
also changes the need to seek approval
E:\FR\FM\16DEP3.SGM
16DEP3
77340
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS3
from the ‘chief public health officer of
the state in which the OTP operates’ to
the State Opioid Treatment Authority
(SOTA) of the state in which the OTP
operates. This change was made to
streamline and centralize the
application process.
An overall goal of these revisions is to
expand access to MOUD, specifically to
OTP services. Accordingly, the range of
services that can be provided in
medication units has been clarified to
improve access to the services OTPs
offer, especially in geographic areas in
which distances are a key barrier to
accessing treatment.
H. Section 8.12—Federal Opioid Use
Disorder Treatment Standards
OTP regulations currently do not
reflect the changes in OUD treatment
standards that have occurred over the
past 20 years. The dual challenges of the
COVID–19 pandemic and the evolving
opioid overdose epidemic necessitated
review and revision of these regulations.
Significant lessons have been learned
from adapting treatment in response to
the need for physical distancing and
quarantine, and from the results of
implementing flexibilities for take home
doses and use of telehealth under the
COVID–19 PHE.
Overcoming the opioid crisis through
the expansion of prevention, treatment,
and recovery support services is a
primary priority for SAMHSA, and
SAMHSA seeks to expand access to
quality treatment services, encourage
the use of MOUD, and improve
engagement and retention in treatment
and recovery support services.
Consistent with that goal, amendments
to treatment standards incorporated in
this section are intended to improve
access to care and improve patient
satisfaction and engagement in services,
while also promoting flexibility and
medical judgment in decision-making to
reduce the burden of patient
participation in OTPs.
Changes to the ‘‘Required services’’
paragraph incorporate patient-centered
language, and promote flexibility in the
use of clinical judgment. For example,
required services are amended to assure
that OTPs meet patient needs, and
‘‘shared decision making’’ is added to
ensure that the patient be included in
the development and implementation of
their care plan. In several instances, the
intent of standards was not changed, but
stigmatizing wording such as
‘‘legitimate treatment use’’ of controlled
substances has been removed. These
amendments are incorporated as a
means of reducing the use of
stigmatizing attitudes, practices and
language within OTPs that may
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
contribute to discrimination and impede
access to treatment.65
Other revisions in this section are
included to ensure alignment with laws
and regulations that have been issued
since 2001 and to emphasize their
importance to OTPs. These include
HIPAA, the Comprehensive Addiction
and Recovery Act (CARA), and the
Substance Use-Disorder Prevention that
Promotes Opioid Recovery and
Treatment for Patients and Communities
(SUPPORT) Act. Section 303 of CARA,
for example, expanded the definition of
‘‘qualifying practitioners’’ from
physicians to include nurse
practitioners and physician assistants
who meet certain criteria; this change
has been included in the section on staff
credentials and is in alignment with the
professionalization of SUD treatment
services that has occurred over the last
20 years. 66 67
A significant change in OTP access is
the removal of the requirement that
patients must have had an addiction to
opioids for at least one year prior to
admission for MOUD; this is a vestige of
prior versions of the DSM and has posed
a barrier to access to treatment. OUD
includes signs and symptoms that are
associated with compulsive, prolonged
use of opioid substances for nonmedical purposes, despite harm and
negative consequences to the individual
with OUD. Therefore, the assessment of
OUD is refocused, in the proposed rule,
to consideration of problematic patterns
of opioid use that are in line with the
current version of the DSM diagnostic
categories.68 The proposed rules also
recognize the potential for recurrence of
OUD in individuals who have sustained
remission and recovery and the high
mortality risk associated with these
situations. The revised definition allows
for clinical judgment and consideration
of severity of use and comorbid
conditions. The new rules also remove
the requirement that individuals under
18 must have two documented
65 See https://www.justice.gov/opa/pr/justicedepartment-issues-guidance-protections-peopleopioid-use-disorder-under-americans.
66 Center for Substance Abuse Treatment.
Competencies for Substance Abuse Treatment
Clinical Supervisors. Technical Assistance
Publication (TAP) Series 21–A. HHS Publication
No. (SMA) 12–4243. Rockville, MD: Substance
Abuse and Mental Health Services Administration,
2007/2013.
67 Center for Substance Abuse Treatment. Clinical
Supervision and Professional Development of the
Substance Abuse Counselor. Treatment
Improvement Protocol (TIP) Series 52. HHS
Publication No. (SMA) 144435. Rockville, MD:
Substance Abuse and Mental Health Services
Administration, 2009/2014.
68 See https://www.aoaam.org/resources/
Documents/Clinical%20Tools/DSM-V%20Criteria
%20for%20opioid%20use%20disorder%20.pdf.
PO 00000
Frm 00012
Fmt 4701
Sfmt 4702
unsuccessful attempts at treatment
within one year to be eligible for
MOUD. Except where not required by
state law, parental consent to treatment
remains a requirement for patients
under age 18. In recognition of the use
of telehealth and the limitation of
obtaining written consent, the
requirement for a written form of
consent to treatment was removed for
adult patients.
Throughout the document,
‘‘detoxification’’ and the corresponding
definition and standards for short- and
long-term detoxification have been
removed as the word ‘‘detoxification’’ is
considered a pejorative term and not
accurately reflective of the process of
managing or experiencing the
withdrawal associated with substances
or medications to which physiologic
tolerance develops. Detoxification is an
outdated term that was used to
distinguish opioid dependence from
OUD based on the Narcotic Addiction
Treatment Act of 1974 (NATA).
Practice-based evidence and extensive
research shows that treatment with
MOUD is more effective than
withdrawal management at reducing
OUD recurrence and associated
mortality and morbidity risk.69
However, it is recognized that some
patients may choose, or need, to taper
off MOUD. Therefore, ‘‘withdrawal
management’’ and terms for tapering
from MOUD are included in the section
of the regulations that currently refer to
‘‘detoxification.’’
Language used in the current rule
about the initial medical examination
required clarification to distinguish
between an initial ‘‘screening’’ exam
and a more comprehensive
‘‘examination.’’ For patients with OUD,
initiating MOUD is of utmost
importance to suppress withdrawal,
engage the individual in additional
services, and improve retention. The
need to improve access to treatment
necessitates expanding the
qualifications of those practitioners able
to complete screening examinations.
The proposed rule allows practitioners
who work outside of the OTP (with
limitations and specific instructions) to
undertake screening. This is likely to
reduce delays in diagnosing OUD,
initiating MOUD, and in beginning
comprehensive treatment. This section
also improves medical services by
setting expectations for lab testing,
establishing time frames for
examinations, and incorporating use of
69 Kleber HD. Pharmacologic treatments for
opioid dependence: detoxification and maintenance
options. Dialogues Clin Neurosci. 2007;9(4):455–70.
doi: 10.31887/DCNS.2007.9.2/hkleber. PMID:
18286804; PMCID: PMC3202507.
E:\FR\FM\16DEP3.SGM
16DEP3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS3
telehealth. Special services for pregnant
people have been revised to specify that
confirmation of pregnancy is required
for priority treatment admissions to
prevent misuse of priority status. The
option to use split dosing for patients
was added to this section, as well.
Changes to the initial and periodic
medical services sections are intended
to promote key issues for OTP medical
practitioners and the OTP multidisciplinary team to address with a
patient as part of treatment. This
includes areas that may increase the risk
of a patient leaving care prematurely,
such as unmet mental health or other
disability, medical and oral health
needs, the need for culturally
supportive care that addresses race,
ethnicity, sexual orientation, religion or
gender identity, and social determinants
of health, such as housing and
transportation, that may pose barriers to
treatment engagement, or harm
reduction and recovery support service
needs. Patient-centered language was
added to ensure that the care provided
is consistent with the patient’s needs,
and self-identified goals for treatment
and recovery. The time frames for
completion of the care plan are included
as a measure of quality. Also included
is the requirement in § 8.12(f)(4)(i) that
individuals starting treatment be
screened for imminent risk of harm to
self or others. This recognizes that risk
for suicide is increased among
individuals who misuse substances 70
and that appropriate screening,
intervention, and referrals for care are
vital to health and engagement in
treatment activities.71
Counseling services have been more
finely described to align OTP services
with the current paradigm for evidencebased SUD treatment. This includes the
delineation of psychoeducational
services, overdose prevention and other
harm reduction counseling, and
recovery-oriented counseling services.
Specific counseling on reducing HIV,
hepatitis C, and other STIs, and linkage
to treatment for anyone with positive
test results from OTP-provided
laboratory testing, was added to
improve quality of care. Language about
services that must be provided directly
or through referral has also been revised
70 Substance Abuse and Mental Health Services
Administration (2015). Substance Use and Suicide:
A Nexus Requiring a Public Health Approach. In
Brief.
71 Lynch Fl., Peterson EL, Lu CY, Hu Y, Rossom
RC, Waitzfelder BE, Owen-Smith AA, Hubley S,
Parbhakar D, Keoki Williams L, Beck A, Simon GE,
Ahmedani BK. Substance use disorders and risk of
suicide in a general US population: a case control
study. Addict Sci Clin Pract. 2020 Feb 21;15(1):14.
doi:10.1186/s13722-020-0181-1. PMID: 32085800;
PMCID: PMC7035727.
VerDate Sep<11>2014
22:09 Dec 15, 2022
Jkt 259001
to infuse a more patient-centered
approach, such as in ‘‘identified and
mutually agreed-upon as beneficial by
the patient and program staff,’’ rather
than the program staff determining that
the patient is ‘‘in need of such services.’’
Drug testing services have been
revised to remove the stigmatizing
language of ‘‘drug abuse,’’ to remove
content on short-term withdrawal
management (‘‘detoxification’’), and to
improve readability. The requirement
for use of drug tests that have received
FDA’s marketing authorization was
added to assure valid assays are used.
The current regulations require OTPs
to review whether a patient is enrolled
in another OTP prior to admission.
Simultaneous enrollment in multiple
OTPs risks patients obtaining more
medication than is needed. Good faith
efforts to prevent this must be
documented. Therefore, the language
regarding verification of non-enrollment
changed from ‘‘review’’ to ‘‘determine’’
in order to ensure that evidence of good
faith efforts is available. This section
also expands the circumstances in
which a patient may obtain treatment at
another OTP to include instances when
there is an inability to access care at the
OTP of record. Experiences of state and
OTP responses to occurrence of natural
disasters gave evidence of the need to
incorporate this allowance on behalf of
patients.
In § 8.12(h) (Medication
administration, dispensing, and use),
the specific disciplines authorized to
administer or dispense MOUD have
been removed to accommodate
variations among states regarding
disciplines allowed to provide this
service. Among medications used by
OTPs, LAAM has been removed as it
has black box warnings and is no longer
commercially available, while other
medications approved since 2001
(naltrexone) were added. Although the
maximum initial dose of methadone
remains at 30 mg, use of clinical
judgment in dose adjustments is
underscored, due to higher opioid
tolerance associated with increasing
rates of fentanyl exposure and opioid
overdose. Should 30 mg be insufficient
to control symptoms of withdrawal, the
program physician or practitioner may
increase the dosage, provided that the
rationale for this change is appropriately
documented. The requirement that the
program physician be familiar with the
most up-to-date product labeling has
been removed as § 8.12(d) requires that
each person engaged in the treatment of
OUD must have sufficient education,
training, and experience, or any
combination thereof, to enable that
person to perform the assigned
PO 00000
Frm 00013
Fmt 4701
Sfmt 4702
77341
functions. This is inclusive of the
expectation that all program medical
practitioners maintain familiarity with
the most up-to-date product labeling for
the medications they administer and
dispense to patients.
The exemption policies promulgated
by SAMHSA in response to COVID–19
allowed OTPs to provide more take
home doses of methadone to patients on
a more rapid schedule than is permitted
in the current regulations. In the two
years since implementation, there have
been few reports of overdose or harm
related to take homes, misuse, or other
negative consequences of this flexibility.
Evidence from multiple studies has
shown that increases in take home doses
following the SAMHSA exemption did
not lead to worse treatment outcomes,
higher overdose rates, or diversion of
medication, but instead resulted in
increased treatment engagement and
improved patient satisfaction with
care.72 73 74 75 There are sufficient studies
to conclude that this exemption has
enhanced and encouraged use of and
retention in OTP services; therefore, the
proposed rule for unsupervised (take
home) doses fully incorporates the
flexibilities for take home medication
issued during the COVID–19 PHE.
The proposed rule removes
stigmatizing language in favor of personcentered approaches and person-first
terminology. Changes focus on the wellbeing of the individual and reframe the
criteria for unsupervised medication
from rule-based to clinical judgmentbased decisions. When determining take
home medication schedules under the
proposed rule, SAMHSA recommends
that the best interest of each patient and
the public’s health be taken into
consideration, and that clinical
judgement, not rigid rules, determine if
the therapeutic benefit of take home
72 Figgatt, M.C., Salazar, Z., Day, E., Vincent, L.,
& Dasgupta, N. (2021). Take-home dosing
experiences among persons receiving methadone
maintenance treatment during COVID–19. Journal
of substance abuse treatment, 123, 108276. https://
doi.org/10.1016/j.jsat.2021.108276.
73 Joseph, G., Torres-Lockhart, K., Stein, M.R.,
Mund, P.A., & Nahvi, S. (2021). Reimagining
patient-centered care in opioid treatment programs:
Lessons from the Bronx during COVID–19. Journal
of substance abuse treatment, 122, 108219. https://
doi.org/10.1016/j.jsat.2020.108219.
74 Amram, O., Amiri, S., Panwala, V., Lutz, R.,
Joudrey, P.J., & Socias, E. (2021). The impact of
relaxation of methadone take-home protocols on
treatment outcomes in the COVID–19 era. The
American journal of drug and alcohol abuse, 47(6),
722–729. https://doi.org/10.1080/00952990.
2021.1979991.
75 Brothers S., Viera A., Heimer R. Changes in
methadone program practices and fatal methadone
overdose rates in Connecticut during COVID–19
Journal of Substance Abuse Treatment. 2021
Dec;131:108449. doi: 10.1016/j.jsat.2021.108449.
Epub 2021 Apr 29. PMID: 34098303.
E:\FR\FM\16DEP3.SGM
16DEP3
77342
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS3
medication outweighs the risks to the
patient and public health. The proposed
rule is meant to address barriers to care
associated with the requirement for
regular clinic attendance while also
improving patient satisfaction and
treatment engagement in a manner that
also balances patient and public health
safety.
The conditions for interim treatment
extend the potential duration of this
approach from 120 days to 180 days.
This is based on SAMHSA’s experience
and reports from states that the
underlying issues which prompted
interim treatment, such as staff
shortages, are not easily resolved in 120
days.76 77 In addition, interim services
may serve as a low-threshold approach
to engaging individuals with OUD in
care, particularly in areas where OTPs
offering more comprehensive services
are not as readily available. Clarification
of language in this section also ensures
that patients in interim treatment have
documented plans for continuation of
treatment beyond 180 days, and are not
discharged based on length of time in
interim care. The circumstances in
which a patient could receive interim
services required clarification from
‘‘cannot be placed in a public or
nonprofit private program’’ to ‘‘if
comprehensive services are not readily
available.’’ Services to be provided in
this category are revised to assure
alignment of quality expectations for
interim care between OTPs and
SAMHSA.
On July 28, 2021, the DEA published
a final rule that permits DEA registrants
who are authorized to dispense
methadone for OUD to add a ‘‘mobile
component’’ to their existing
registration—waiving any requirement
that mobile medication units of OTPs
operating in compliance with the rule
separately register at their remote
dispensing locations (86 FR 33861).
This expanded opportunities for OTPs
to provide needed services in remote or
underserved areas. Through use of
Substance Abuse Prevention and
Treatment Block Grant (SABG) funds,
SAMHSA encouraged OTPs to establish
medication units as a means of making
treatment more readily available,
especially to those people in remote,
rural, or underserved areas. To further
the goal of improving and expanding
76 Sigmon SC. Interim treatment: Bridging delays
to opioid treatment access. Prev Med. 2015;80:32–
36. doi:10.1016/j.ypmed.2015.04.017.
77 Oleskowicz TN, Ochalek TA, Peck KR, Badger
GJ, Sigmon SC. Within-subject evaluation of interim
buprenorphine treatment during waitlist delays.
Drug Alcohol Depend. 2021 Mar 1;220:108532. doi:
10.1016/j.drugalcdep.2021.108532. Epub 2021 Jan
20. PMID: 33508690; PMCID: PMC8148627.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
access, the range of services that can be
provided in medication units are
described in the proposed rule. Such
services must be delivered in
accordance with the nondiscrimination
provision at 42 U.S.C. 300x–57, which
state that: ‘‘No person shall on the
ground of sex (including, in the case of
a woman, on the ground that the woman
is pregnant), or on the ground of
religion, be excluded from participation
in, be denied the benefits of, or be
subjected to discrimination under, any
program or activity funded in whole or
in part with funds made available under
section 300x or 300x–21 of this title.’’
I. Section 8.14—Suspension or
Revocation of Certification
This section clarifies the actions that
SAMHSA may take when immediate
intervention is necessary to protect the
public’s health or safety. The proposed
rule specifies the administrative actions
available to SAMHSA in the event that
a program sponsor, or any employee of
an OTP has: been found guilty of
misrepresentation in obtaining
certification; failed to comply with the
Federal Opioid Use Disorder treatment
standards; failed to comply with
reasonable requests from SAMHSA or
from an accreditation body for records;
or refused a reasonable request of a duly
designated SAMHSA inspector, DEA
Inspector, State Inspector, or
accreditation body representative for
permission to inspect the program or the
program’s operations or its records.
J. Subpart F—Authorization To Increase
Patient Limit to 275 Patients
This subpart is amended to change
the format from a Question-and-Answer
style to a standard narrative text format.
This is for consistency with the format
found throughout the proposed rule.
K. Section 8.610—Practitioner Eligibility
Requirements for a 3-Year 275-Patient
Limit
This section clarifies the 3-year limit
to the 275-patient limit.
L. Section 8.635—What are the reporting
requirements for practitioners whose
275 request for patient limit is
approved?
As of May 2022, there were 8,641
practitioners waivered at the 275-level
and of these, 5,905 were Doctors of
Medicine and Doctors of Osteopathic
Medicine (MD/DOs). The proposed rule
removes reporting requirements for
practitioners at this level. Practitioners
have found the submission of these
reports to be burdensome and a
disincentive to treating a higher number
PO 00000
Frm 00014
Fmt 4701
Sfmt 4702
of patients.78 As increasing numbers of
Americans lose their lives to overdose,
it is essential to support practitioners
and to remove perceived disincentives
or barriers to treating more patients. In
this way, the extent of the overdose
crisis as a result of the COVID–19 PHE
outweighs the potential value of data
obtained from compliant reporters. The
proposed rule removes reporting
requirements for those who are
authorized to treat up to 275 patients
with buprenorphine. Rather than expect
practitioners to submit reports,
SAMHSA will seek to work in
partnership with other Federal agencies
for monitoring purposes.
Further to this, reporting
requirements are known to perpetuate
stigma towards MOUD and to
potentially reduce prescribing of a lifesaving medication.79 Negative attitudes
and beliefs toward use of medications in
treating OUD is common among
healthcare professionals, members of
law enforcement and others in justice
settings, in the wider community, and
even among persons with OUD
themselves.80 Of primary care
physicians in a national survey, just
over three quarters (77.5%) perceived
buprenorphine to be an effective
treatment for OUD.81 Many treatment
programs and support groups
discourage participants from using
medications, including MOUD.82 Young
adults with OUD experience difficulties
obtaining or remaining on
buprenorphine as a result of stigma from
healthcare providers, 12-step programs,
residential treatment programs, and
78 Lanham, H.J., Papac, J., Olmos, D.I.,
Heydemann, E.L., Simonetti, N., Schmidt, S., &
Potter, J.S. (2022). Survey of Barriers and
Facilitators to Prescribing Buprenorphine and
Clinician Perceptions on the Drug Addiction
Treatment Act of 2000 Waiver. JAMA network
open, 5(5), e2212419. https://doi.org/10.1001/
jamanetworkopen.2022.12419.
79 Pew Charitable Trusts (2019). Why Aren’t More
People With Opioid Use Disorder Getting
Buprenorphine? Available at: https://
www.pewtrusts.org/en/research-and-analysis/
articles/2019/07/31/why-arent-more-people-withopioid-use-disorder-getting-buprenorphine.
80 Scorsone, K.L., Haozous, E.A., Hayes, L., & Cox,
K.J. (2020). Overcoming Barriers: Individual
Experiences Obtaining Medication-Assisted
Treatment for Opioid Use Disorder. Qualitative
health research, 30(13), 2103–2117. https://doi.org/
10.1177/1049732320938689.
81 McGinty, E.E., Stone, E.M., KennedyHendricks, A., Bachhuber, M.A., & Barry, C.L.
(2020). Medication for Opioid Use Disorder: A
National Survey of Primary Care Physicians. Annals
of internal medicine, 173(2), 160–162. https://
doi.org/10.7326/M19-3975.
82 Beetham, T., Saloner, B., Gaye, M., Wakeman,
S.E., Frank, R.G., & Barnett, M.L. (2020). Therapies
Offered at Residential Addiction Treatment
Programs in the United States. JAMA, 324(8), 804–
806. https://doi.org/10.1001/jama.2020.8969.
E:\FR\FM\16DEP3.SGM
16DEP3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
parents.83 Prejudice against MOUD even
exists among specialist SUD treatment
providers. One 2020 national survey of
residential OUD treatment programs
found that less than a third (29%)
offered maintenance treatment with
buprenorphine-naloxone; many
programs actively discouraged the use
of medication, which are the standard of
care, revealing that there is a vast
knowledge gap about MOUD among
treatment providers.84
Proposed changes to part 8 seek to
reduce discriminatory attitudes and
beliefs, and to incorporate evidencebased principles on practitioner
autonomy, patient-centered decision
making and individualized care plans.
This is in line with the chronic disease
model of care,85 and represents a
departure from the prescriptive model
of care currently in place. In this way,
The Department seeks to support
practitioners in providing evidencebased and compassionate care to
patients while also engaging them in
recovery. This is an essential means of
reducing stigma among practitioners
and community members, while also
positively addressing a patient’s
internalized stigma.86
Request for Comments
The Department requests public
comment on all aspects of the proposed
amendments to the regulations at 42
CFR part 8, Medications for the
Treatment of Opioid Use Disorder. The
Department welcomes public comment
on any benefits or drawbacks of the
proposed amendments set forth above in
this proposed rule. Of particular interest
are comments pertaining to: interim
treatment; split dosing; telehealth; and
take home doses of methadone.
lotter on DSK11XQN23PROD with PROPOSALS3
Public Participation
The Department seeks comment on all
issues raised by the proposed
regulation, including any potential
83 Hadland, S.E., Park, T.W., & Bagley, S.M.
(2018). Stigma associated with medication
treatment for young adults with opioid use
disorder: a case series. Addiction science & clinical
practice, 13(1), 15. https://doi.org/10.1186/s13722018-0116-2.
84 Beetham, T., Saloner, B., Gaye, M., Wakeman,
S.E., Frank, R.G., & Barnett, M.L. (2020). Therapies
Offered at Residential Addiction Treatment
Programs in the United States. JAMA, 324(8), 804–
806. https://doi.org/10.1001/jama.2020.8969.
85 Grover, A., & Joshi, A. (2014). An overview of
chronic disease models: a systematic literature
review. Global journal of health science, 7(2), 210–
227. https://doi.org/10.5539/gjhs.v7n2p210.
86 Idemudia, E.S., Olasupo, M.O., & Modibo,
M.W. (2018). Stigma and chronic illness: A
comparative study of people living with HIV and/
or AIDS and people living with hypertension in
Limpopo Province, South Africa. Curationis, 41(1),
e1–e5. https://doi.org/10.4102/curationis.
v41i1.1879.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
unintended adverse consequences.
Because of the large number of public
comments normally received on Federal
Register documents, the Department is
not able to acknowledge or respond to
them individually. In developing the
final rule, the Department will consider
all comments that are received by the
date and time specified in the DATES
section of the Preamble.
Because mailed comments may be
subject to delays due to security
procedures, please allow sufficient time
for mailed comments to be received by
the deadline in the event of delivery
delays. Any attachments submitted with
electronic comments on
www.regulations.gov should be in
Microsoft Word or Portable Document
Format (PDF). Please note that
comments submitted by fax or email
and those submitted after the comment
period deadline will not be accepted.
Regulatory Impact Analysis
The Department has examined the
impact of the proposed rule as required
by Executive Order 12866 on Regulatory
Planning and Review, 58 FR 51735
(October 4, 1993); Executive Order
13563 on Improving Regulation and
Regulatory Review, 76 FR 3821 (January
21, 2011); Executive Order 13132 on
Federalism, 64 FR 43255 (August 10,
1999); Executive Order 13175 on
Consultation and Coordination with
Indian Tribal Governments, 65 FR
67249 (November 9, 2000); Executive
Order 13985 Advancing Racial Equity
and Support for Underserved
Communities Through the Federal
Government, 86 FR 7009 (January 25,
2021); the Congressional Review Act,
Public Law 104–121, sec. 251, 110 Stat.
847 (March 29, 1996); the Unfunded
Mandates Reform Act of 1995, Public
Law 104–4, 109 Stat. 48 (March 22,
1995); the Regulatory Flexibility Act,
Public Law 96–354, 94 Stat. 1164
(September 19, 1980); Executive Order
13272 on Proper Consideration of Small
Entities in Agency Rulemaking, 67 FR
53461 (August 16, 2002); the
Assessment of Federal Regulations and
Policies on Families, Public Law 105–
277, sec. 654, 112 Stat. 2681 (October
21, 1998); and the Paperwork Reduction
Act of 1995, Public Law 104–13, 109
Stat. 163 (May 22, 1995).
Statement of Need
This proposed rule is being issued to
update part 8 in response to increasing
opioid overdose deaths, exacerbated by
the COVID–19 pandemic.87 Across the
87 Cartus AR, Li Y, Macmadu A, Goedel WC,
Allen B, Cerda´ M, Marshall BDL. Forecasted and
Observed Drug Overdose Deaths in the US During
PO 00000
Frm 00015
Fmt 4701
Sfmt 4702
77343
United States in 2020, 9.5 million
people aged 12 or older misused heroin
or prescription pain relievers.88 The
percentage was highest among young
adults aged 18 to 25 (4.1 percent or 1.4
million people), followed by adults aged
26 or older (3.4 percent or 7.5 million
people). It was lowest among
adolescents aged 12 to 17 (1.6 percent
or 396,000 people).88 These numbers
likely underestimate the true prevalence
of opioid misuse and OUD, since the
use of illicitly manufactured fentanyl
has not to date been considered in the
National Survey on Drug Use and
Health (NSDUH) survey, and
populations likely to have high
prevalence of opioid misuse and use
disorder, such as individuals in the
criminal justice system, other
institutionalized settings, and
individuals experiencing homelessness
not living in shelters are not included in
the NSDUH.
Further to this, there are important
equity considerations evidenced by the
data. A recent analysis by the Centers
for Disease Control and Prevention
(CDC) demonstrates high levels of
overdose among Black, American Indian
and Alaska Native communities over the
course of the pandemic.89 This study
showed that overdose death rates rose
44 percent in 2020 for Black people and
39 percent for American Indian and
Alaska Native people, compared with 22
percent for white people.89 Black youth
ages 15 to 24 saw an 86 percent increase
in overdose deaths, the largest spike of
any age or race group, while Black men
65 and older were nearly seven times as
likely than white men to die from an
overdose.89 It was also found that Black
people were less than half as likely as
white people to have received substance
use treatment.
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
the COVID–19 Pandemic in 2020. JAMA Netw
Open. 2022 Mar 1;5(3):e223418. doi: 10.1001/
jamanetworkopen.2022.3418. PMID: 35311967;
PMCID: PMC8938716.
88 Substance Abuse and Mental Health Services
Administration. (2021). Key substance use and
mental health indicators in the United States:
Results from the 2020 National Survey on Drug Use
and Health (HHS Publication No. PEP21–07–01–
003, NSDUH Series H–56). Rockville, MD: Center
for Behavioral Health Statistics and Quality,
Substance Abuse and Mental Health Services
Administration. Retrieved from https://
www.samhsa.gov/data/.
89 Kariisa M, Davis NL, Kumar S, et al. Vital
Signs: Drug Overdose Deaths, by Selected
Sociodemographic and Social Determinants of
Health Characteristics—25 States and the District of
Columbia, 2019–2020. MMWR Morb Mortal Wkly
Rep 2022;71:940–947. DOI: https://dx.doi.org/
10.15585/mmwr.mm7129e2.
E:\FR\FM\16DEP3.SGM
16DEP3
77344
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS3
anxiety diagnosis; depression diagnosis;
receipt of methadone, buprenorphine,
opioid, and benzodiazepine
prescriptions in the 12 months before
index nonfatal opioid overdose; and
time-varying receipt of opioid
prescriptions, benzodiazepine
prescriptions, withdrawal management
episode, and short- and long-term
residential treatments 90), yet few people
who may benefit from these medications
have immediate and sustained access to
them.91
The pattern of enrollment in programs
providing methadone was established in
the latter part of the 20th century.92
Research reveals that the rate of
methadone treatment at that time was
highest in low income urban areas.93
These patterns have remained relatively
unchanged since the expansion of
access to buprenorphine in 2002.
Research demonstrates that there are
extensive ‘treatment deserts’ where
there is little to no physical access to
OTPs, especially in rural areas.94
SAMHSA believes that proposed
changes to part 8 will, as described
above, facilitate:
• Enhanced access to medications for
opioid use disorder, such as through
take home doses of methadone and
extending interim treatment to 180 days;
• Changes to ensure updated
language and terminology;
• Clarification of standards applying
to accreditation bodies;
• Revising Federal Opioid Use
Disorder Treatment Standards; and
• Removing reporting requirements
for practitioners approved to treat up to
275 patients.
SAMHSA notes below that these
changes are associated with limited
90 Larochelle MR, Bernson D, Land T, Stopka TJ,
Wang N, Xuan Z, Bagley SM, Liebschutz JM, Walley
AY (2018). Medication for Opioid Use Disorder
After Nonfatal Opioid Overdose and Association
With Mortality: A Cohort Study. Ann Intern Med.
Aug 7;169(3):137–145. doi: 10.7326/M17–3107.
91 Winograd RP, Presnall N, Stringfellow E, Wood
C, Horn P, Duello A, Green L, Rudder T. (2019). The
case for a medication first approach to the treatment
of opioid use disorder. Am J Drug Alcohol Abuse.
2019;45(4):333–340. doi: 10.1080/
00952990.2019.1605372. Epub 2019 May 14. PMID:
31084515.
92 D’Aunno T, Pollack HA. (2002). Changes in
methadone treatment practices: results from a
national panel study, 1988–2000. JAMA.
2002;288(7):850–856. doi:10.1001/jama.288.7.850.
93 Strain EC, Stitzer ML, Liebson IA, Bigelow GE.
(1994). Comparison of buprenorphine and
methadone in the treatment of opioid dependence.
Am J Psychiatry. 1994 Jul;151(7):1025–30. doi:
10.1176/ajp.151.7.1025. PMID: 8010359.
94 Mitchell P, Samsel S, Curtin KM, Price A,
Turner D, Tramp R, Hudnall M, Parton J, Lewis D.
(2022). Geographic disparities in access to
Medication for Opioid Use Disorder across US
census tracts based on treatment utilization
behavior. Soc Sci Med. 2022 Jun;302:114992. doi:
10.1016/j.socscimed.2022.114992. Epub 2022 Apr
28. PMID: 35512612.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
burden as the proposed rule does not
substantially alter reporting or
accreditation activities. The changes
proposed will support SAMHSA in its
role of overseeing accrediting bodies
and OTPs, modernizing language and
expectations in response to current
challenges and anticipated future
trends. SAMHSA invites comments on
the assumptions of costs and benefits
identified below, including citations to
any publicly available studies or reports
that could elucidate and improve this
analysis.
A. Executive Orders 12866 and 13563
and Related Executive Orders on
Regulatory Review
Executive Order 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
if regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety effects; distributive impacts;
and equity). Executive Order 13563 is
supplemental to, and reaffirms the
principles, structures, and definitions
governing regulatory review as
established in, Executive Order 12866.
This proposed rule is partially
regulatory and partially deregulatory.
The Department estimates that because
much of what is being proposed does
not substantially alter current practice
as implemented over the past 2 years
under the COVID PHE, the proposed
rule will not result in significantly
altered costs. Further to this, the
proposed rule creates efficiencies in
service delivery and in administration.
These include strengthening the patientpractitioner relationship in a manner
that promotes efficient, evidence-based
and patient-centered care, updating
accreditation procedures and providing
a stable regulatory environment.
Additionally, the proposed rule makes
permanent some OTP treatment
flexibilities implemented within the
past two years.
B. Executive Order 13985 Advancing
Racial Equity and Support for
Underserved Communities Through the
Federal Government
trends existed long before the COVID–
19 PHE, this study highlights that
overdose death rates rose 44 percent in
2020 for Black people and 39 percent for
American Indian and Alaska Native
people, compared with 22 percent for
white people.95 Black youth ages 15 to
24 saw an 86 percent increase in
overdose deaths, the largest spike of any
age or race group, while Black men 65
and older were nearly seven times as
likely than white men to die from an
overdose.95 It was also found that Black
people were less than half as likely as
white people to have received substance
use treatment.
This disparity amplifies the
importance of promoting personcentered care that is culturally
appropriate and responsive to patient
need, while also fostering a treatment
environment that promotes and sustains
patient engagement. The proposed
changes facilitate the practitionerpatient relationship in a manner that
espouses these principles, while also
expanding the reach of OTPs (through
activities such as mobile medication
units) to physically engage communities
that are in need of intervention. Further
to this, the proposed changes promote
examination of a patient’s cultural
needs as they engage in treatment
services. This is consistent with
evidence-based and culturally
responsive paradigms of care.
The proposed changes also facilitate
patient engagement through removing,
at the practitioner’s discretion, the
requirement to attend an OTP each day.
Indeed, the ability to provide
unsupervised doses of methadone early
in treatment allows those with unstable
access to transportation, for example, to
focus on recovery activities in their own
community. Evidence from the past two
years demonstrates safety, as well as
high patient and practitioner
satisfaction with take-home doses of
methadone. This is principally because
unsupervised doses of methadone allow
individuals the opportunity to engage in
employment or other activities that are
supportive of recovery and longer term
community involvement.
1. Cost-Benefit Analysis
A recent analysis by the Centers for
Disease Control and Prevention (CDC)
demonstrates high levels of overdose
among Black, American Indian and
Alaska Native communities over the
course of the pandemic.95 While these
a. Overview
The U.S. estimated economic cost of
opioid use disorder ($471 billion) and
fatal opioid overdose ($550 billion),
prior to the pandemic, totaled $1,021
billion.96 Among the 39 jurisdictions
95 Kariisa M., Davis N.L., Kumar S., et al. Vital
Signs: Drug Overdose Deaths, by Selected
Sociodemographic and Social Determinants of
Health Characteristics—25 States and the District of
Columbia, 2019–2020. MMWR Morb Mortal Wkly
Rep 2022;71:940–947. DOI: https://dx.doi.org/
10.15585/mmwr.mm7129e2.
96 Luo, F., Li, M., & Florence, C. (2021). StateLevel Economic Costs of Opioid Use Disorder and
Fatal Opioid Overdose—United States, 2017.
PO 00000
Frm 00016
Fmt 4701
Sfmt 4702
E:\FR\FM\16DEP3.SGM
16DEP3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS3
reviewed in this analysis, combined
costs of opioid use disorder and fatal
opioid overdose varied from $985
million in Wyoming to $72.6 billion in
Ohio. Per capita combined costs varied
from $1,204 in Hawaii to $7,247 in West
Virginia. States with high per capita
combined costs were located mainly in
the Ohio Valley and New England.
Across many studies, reduced quality of
life is the largest component of the cost
of opioid use disorder.97
A recent study showed that in the
absence of treatment, 42,717 overdoses
(4,132 fatal, 38,585 nonfatal) and 12,660
deaths were estimated to occur in a
cohort of 100,000 patients over 5
years.98 An estimated reduction in
overdoses was associated with
methadone treatment (10.7%),
buprenorphine or naltrexone treatment
(22.0%), and medication treatment
combined with psychotherapeutic
interventions (range, 21.0%–31.4%).98
Estimated decreased deaths were
associated with treatment with
methadone (6%), buprenorphine or
naltrexone (13.9%), and the
combination of medications and
psychotherapy (16.9%). When criminal
justice costs were included, all forms of
MOUD (with buprenorphine,
methadone, and naltrexone) were
associated with cost savings compared
with no treatment, yielding savings of
$25,000 to $105,000 in lifetime costs per
person.
McAdam-Marx et al. reported in 2010
that Medicaid beneficiaries with opioid
use disorder, physical dependence on
opioids, or poisoning had nearly triple
the total medical costs adjusted for
baseline sample characteristics
compared to beneficiaries matched by
age, gender, and state with no opioid
misuse diagnosis ($23,556 vs. $8436; P
< 0.001).99 The opioid dependence/
abuse group (using an older version of
the Diagnostic and Statistical Manual of
Mental Disorders) also had higher
prevalence of comorbidities, such as
MMWR. Morbidity and mortality weekly report,
70(15), 541–546. https://doi.org/10.15585/
mmwr.mm7015a1.
97 Mitchell, S.G., Gryczynski, J., Schwartz, R.P.,
Myers, C.P., O’Grady, K.E., Olsen, Y.K., & Jaffe, J.H.
(2015). Changes in Quality of Life following
Buprenorphine Treatment: Relationship with
Treatment Retention and Illicit Opioid Use. Journal
of psychoactive drugs, 47(2), 149–157. https://
doi.org/10.1080/02791072.2015.1014948.
98 Fairley M., Humphreys K., Joyce V.R., et al.
(2021). Cost-effectiveness of Treatments for Opioid
Use Disorder. JAMA Psychiatry. 2021;78(7):767–
777. doi:10.1001/jamapsychiatry.2021.0247.
99 McAdam-Marx C., Roland C.L., Cleveland J.,
Oderda G.M. (2010). Costs of opioid abuse and
misuse determined from a Medicaid database. J
Pain Palliat Care Pharmacother. 2010 Mar;24(1):5–
18. doi: 10.3109/15360280903544877. PMID:
20345194.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
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.100 101 102 For
example, a 2019 analysis demonstrated
that a comprehensive approach to OUD
treatment is associated with improved
health and economic outcomes.103 This
study assessed patients with OUD
treated at a comprehensive primary care
center (CCP) and other Maryland
facilities in a large state Medicaid
program, and demonstrated cost savings
with a comprehensive approach to care.
Compared to the non-CCP patient group
(n = 867), the CCP group (n = 131) had
a higher 6-month buprenorphine
treatment retention rate (P < 0.001),
fewer hospital stays in the 12-month
follow-up period (P = 0.005), and lower
total cost (US$10,942 vs. $13,097, P <
0.001) and hospital stay cost (US$1448
vs. $4265, P = 0.001).103 Other
measures, including emergency
department utilization and cost,
substance use-related cost, and 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
100 Murphy S.M., Polsky D. (2016). Economic
Evaluations of Opioid Use Disorder Interventions.
Pharmacoeconomics. 2016 Sep;34(9):863–87. doi:
10.1007/s40273–016–0400–5. PMID: 27002518;
PMCID: PMC5572804.
101 Baser O., Chalk M., Fiellin D.A., Gastfriend
D.R. (2011). Cost and utilization outcomes of
opioid-dependence treatments. Am J. Manag Care.
2011 Jun;17 Suppl 8:S235–48. PMID: 21761950.
102 Lynch F.L., McCarty D., Mertens J., Perrin
N.A., Green C.A., Parthasarathy S., Dickerson J.F.,
Anderson B.M., Pating D. (2014). Costs of care for
persons with opioid dependence in commercial
integrated health systems. Addict Sci Clin Pract.
2014 Aug 14;9(1):16. doi: 10.1186/1940–0640–9–16.
PMID: 25123823; PMCID: PMC4142137.
103 Hsu Y.J., Marsteller J.A., Kachur S.G.,
Fingerhood M.I. (2019). Integration of
Buprenorphine Treatment with Primary Care:
Comparative Effectiveness on Retention,
Utilization, and Cost. Idemudia, E.S., Olasupo,
M.O., & Modibo, M.W. (2018). Stigma and chronic
illness: A comparative study of people living with
HIV and/or AIDS and people living with
hypertension in Limpopo Province, South Africa.
Curationis, 41(1), e1–e5. https://doi.org/10.4102/
curationis.v41i1.1879.
PO 00000
Frm 00017
Fmt 4701
Sfmt 4702
77345
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.104
Two prior studies assessed data from
commercial health insurance claims on
the overall health care costs and
utilization rates for those using MOUD
compared to those treated without
MOUD.101 105 The first study found that
over a five-year period, members on
MOUD had 50% lower total annual
health plan costs than those who had
two or more visits to an addiction
treatment setting and no treatment, and
62% lower than those with zero or one
visit for addiction treatment and no
intervention.105 The other study found
that after a six-month period, those on
MOUD had significantly lower overall
annual health plan costs compared to
those with no medication ($10,192 vs.
$14,353; p-value < 0.0001).101 The
difference was driven largely by lower
inpatient services and non-opioidrelated 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 proposed rule does not
substantially alter reporting burden or
accreditation activities. The total
number of burden hours reported in
104 Mohlman M.K., Tanzman B., Finison K.,
Pinette M., Jones C. Impact of Medication-Assisted
Treatment for Opioid Addiction on Medicaid
Expenditures and Health Services Utilization Rates
in Vermont. J Subst Abuse Treat. 2016 Aug; 67:9–
14. doi: 10.1016/j.jsat.2016.05.002. Epub 2016 May
9. PMID: 27296656.
105 McCarty D., Perrin N.A., Green C.A., Polen
M.R., Leo M.C., Lynch F. (2010). Methadone
maintenance and the cost and utilization of health
care among individuals dependent on opioids in a
commercial health plan. Drug Alcohol Depend.
2010 Oct 1;111(3):235–40. doi: 10.1016/
j.drugalcdep.2010.04.018. PMID: 20627427; PMCID:
PMC2950212.
E:\FR\FM\16DEP3.SGM
16DEP3
77346
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
2020–2021 for accreditation body
respondents was approximately 394.70
hours. The total number of burden
hours for OTP respondents during the
same period was 1,868.95 hours. The
annual burden associated with this rule
and the associated forms was estimated
to be 2,263.65 hours.
This analysis quantifies a few limited
categories of paperwork-related costs,
but there are more substantive actions
(with associated costs and benefits) that
would be necessary in the chain of
cause and effect between the rule’s most
direct effects and the health and
mortality consequences that are
implied, above, as being potentially
large if this proposal is finalized. For
instance, relative to the appropriate
analytic baseline (the future in the
absence of the rule), the proposed rule
would facilitate the expansion of mobile
methadone units via their inclusion in
operations, and such expansion would
entail both new use of resources
(costs 106) and then, contingent upon
such costs being incurred, the types of
benefits described above. As a further
example, the accrual of health and
overdose-mortality-avoidance benefits
due to removal of the one-year
requirement for opioid addiction before
patient admission to an OTP would
generally be contingent upon increasing
resource use associated with such
admission.
b. Estimated Costs of Reporting Burdens
for OTPs and Accreditation Bodies
In developing its estimates of the
potential costs of the proposed
regulation, the Department relied
substantially on recent estimates of
burden and cost pertaining to
requirements set forth in 42 CFR part 8.
Hourly labor costs involved in
reporting requirements vary greatly
between programs. Based on wage
estimates obtained from the U.S.
Department of Labor, Bureau of Labor
Statistics, and Occupational
Employment Statistics website, it is
estimated that employees involved in
complying with reporting requirements
range from minimum wage ($7.25)
clerical workers, to counselors averaging
Preparation
time
(hours)
Items
lotter on DSK11XQN23PROD with PROPOSALS3
$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.
Cost/hour
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
Subtotal .........................................................................................................................................
........................
....................
232,184.37
c. Cost Pertaining to Recordkeeping
d. Costs Pertaining to Disclosure
The recordkeeping requirements set
forth in 42 CFR 8.4 and 8.12 include
maintenance of the following: a
patient’s medical examination when
admitted to treatment; a patient’s
history; a care plan; any prenatal
support provided to the patient;
justification of unusually large initial
doses; changes in a patient’s dosage
schedule; the rationale for decreasing a
patient’s clinic attendance; services
provided; and documentation of
physiologic tolerance.
SAMHSA believes that the
recordkeeping requirements are
customary and usual practices within
the medical and behavioral health
treatment communities. Accreditation
bodies also maintain accreditation
records for 5 or more years as a
customary and usual practice. SAMHSA
has neither calculated a response
burden nor a cost burden for these
activities.
The proposed rule includes
requirements that OTPs and
accreditation 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.
106 It would be incorrect to interpret this analytic
discussion as implying that the proposed rule
changes authorization procedures for mobile
methadone units.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
e. Estimate of Annualized Non-Hourly
Cost Burden to Respondents
The proposed rule does not impose
new capital or startup costs beyond the
normal office and laboratory equipment
required for achieving regulatory
compliance. It is estimated that there are
PO 00000
Frm 00018
Fmt 4701
Sfmt 4702
some costs associated with preparation
for the accreditation site visit itself;
assuming that OTP staff spend
approximately 180 hours preparing for
the site visit at an average cost of $85.42
per hour and an average of 1.33 site
visits per facility, the total cost would
be $20,450 or an annualized cost of
$15,376 per facility. For the current
approximately 1,920 affected OTPs
these total annual costs are estimated to
be $29,521,920. The percentage of this
total cost that is associated with
recordkeeping and reporting-only is
difficult to estimate, but it is considered
to be a small fraction of the total
associated with accreditation.
i. Estimate of Annualized Cost to the
Government
The total annualized cost to SAMHSA
for administering 42 CFR part 8 is
estimated at $450,000. This estimate
includes the cost of an outside
contractor to develop and maintain an
extensive on-line system for SAMHSA,
E:\FR\FM\16DEP3.SGM
16DEP3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
opioid treatment programs, State opioid
treatment authorities, accreditation
organizations, and others to have use a
protected website for day-to-day
regulatory activities. This estimate does
not include funds that SAMHSA/CSAT
allocates to its ‘‘look back’’ program that
monitors the adequacy of accreditation
surveys. Of this amount, the total
annualized cost to SAMHSA for
77347
Paperwork Reduction Act activities as a
result of this regulation is estimated as
$221,434, as shown in the following
table.
ANNUALIZED COST TO SAMHSA/CSATT
Item
(purpose)
Hours per
response
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
24,000
20
2
3
3
1
2
10
383
10
12
10
1
1.5
.75
.25
.50
.50
0.33
0.50
0.07
1.00
2.00
40
40
.50
.50
1.00
.50
1.00
1.00
1.00
4.25
63
289.5
8.75
20
7.5
19.8
0.5
1680
20
4
120
120
0.5
1
10
191.5
10
12
10
4.25
$5,381
24,729
747
1,708
641
1,691
43
143,506
1,708
342
10,250
10,250
43
85
854
16,358
854
1,025
854
363
Subtotal .....................................................................................................................
25,036
97.15
2592.3
221,434
2. Consideration of Regulatory
Alternatives
The Department has initiated
rulemaking to make flexibilities issued
during the COVID–19 PHE permanent,
while also updating accreditation and
treatment standards to reflect 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.
lotter on DSK11XQN23PROD with PROPOSALS3
Responses
3. Request for Comments on Costs and
Benefits
The Department requests public
comment on all the estimates,
assumptions, and analyses within the
cost-benefits analysis. As part of this
request, feedback is welcome on the
extent to which cited papers follow
sound scientific practices, such as:
clearly stating null hypotheses and
presenting estimating equations;
ensuring that appendices or other
supplementary materials are available
online, if claimed to be so in the main
body of a paper; using compelling
identification strategies if making causal
claims (for example, establishing
parallel trends pre-intervention if using
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
a difference-in-differences method 107);
and avoiding the types of errors that
Kim et al. (2020 108) and Sanders et al.
(2016 109) indicate are common in
published cost-effectiveness analyses.
The Department also requests comments
on any relevant information or data that
would inform a quantitative analysis of
proposed reforms that the Department
qualitatively addresses in this RIA. The
Department also requests comments on
whether there may be other indirect
costs and benefits resulting from the
proposed changes in the proposed rule
and welcomes additional information
that may help quantify those costs and
benefits.
B. Regulatory Flexibility Act
The Department has examined the
economic implications of this proposed
rule as required by the Regulatory
Flexibility Act (5 U.S.C. 601–612). If a
107 Wing C, Simon K, Bello-Gomez RA (2018).
Designing difference in difference studies: best
practices for public health policy research. Annual
Review of Public Health 39: 453–469.
108 Kim DD, Silver MC, Kunst N, et al. (2020).
Perspective and costing in cost-effectiveness
analysis, 1974–2018. PharmacoEconomics 38:
1135–1145.
109 Sanders GD, Neumann PJ, Basu A, et al.
(2016). Recommendations for conduct,
methodological practices, and reporting of costeffectiveness analyses: second panel on costeffectiveness in health and medicine, JAMA, 1093–
1103.
PO 00000
Frm 00019
Fmt 4701
Sfmt 4702
rule has a significant economic impact
on a substantial number of small
entities, the Regulatory Flexibility Act
(RFA) requires agencies to analyze
regulatory options that would lessen the
economic effect of the rule on small
entities. For purposes of the RFA, small
entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. The Act
defines ‘‘small entities’’ as (1) a
proprietary firm meeting the size
standards of the Small Business
Administration (SBA), (2) a nonprofit
organization that is not dominant in its
field, and (3) a small government
jurisdiction of less than 50,000
population. Because 90 percent or more
of all health care providers meet the
SBA size standard for a small business
or are nonprofit organizations, the
Department generally treats all health
care providers as small entities for
purposes of performing a regulatory
flexibility analysis. The SBA size
standard for health care providers
ranges between a maximum of $8
million and $41.5 million in annual
receipts, depending upon the type of
entity.
For the reasons stated above, it is not
expected that the cost of compliance
would be significant for OTPs or
accreditation bodies. Therefore, this
E:\FR\FM\16DEP3.SGM
16DEP3
77348
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
proposed rule would not result in a
significant negative impact.
C. Unfunded Mandates Reform Act
Section 202(a) of The Unfunded
Mandates Reform Act of 1995 (UMRA)
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
that may result in expenditures in any
one year of $100 million in 1995 dollars,
updated annually for inflation. As of
2022, this threshold is $165 million.
The Department does not anticipate that
this proposed rule would result in the
expenditure by state, local, and tribal
governments, taken together, or by the
private sector, of $165 million or more
in any one year.
D. Executive Order 13132—Federalism
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on state and local
governments, preempts state law, or
otherwise has federalism implications.
The Department does not believe that
this rulemaking would have any
significant federalism implications,
impose significant costs on state or local
governments or preempt state law.
E. Assessment of Federal Regulation
and Policies on Families
Section 654 of the Treasury and
General Government Appropriations
Act of 1999 110 requires Federal
departments and agencies to determine
whether a proposed policy or regulation
could affect family well-being. If the
determination is affirmative, then the
Department or agency must prepare an
impact assessment to address criteria
specified in the law. The Department
believes that the proposed regulations
would positively impact the ability of
patients and families to access treatment
for OUD. The Department does not
anticipate negative impacts on family
well-being as a result of this rulemaking
as described.
F. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (PRA) (Pub. L. 104–13), agencies
are required to submit to the Office of
Management and Budget (OMB) for
review and approval any reporting or
recordkeeping requirements inherent in
a proposed or final rule, and are
required to publish such proposed
requirements for public comment. The
PRA requires agencies to provide a 60day notice in the Federal Register and
solicit public comment on a proposed
collection of information before it is
submitted to OMB for review and
approval. To fairly evaluate whether an
information collection should be
approved by OMB, section 3506(c)(2)(A)
of the PRA requires that the Department
solicit comment on the following issues:
1. Whether the information collection
is necessary and useful to carry out the
proper functions of the agency;
2. The accuracy of the agency’s
estimate of the information collection
burden;
3. The quality, utility, and clarity of
the information to be collected; and
4. Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
The PRA requires consideration of the
time, effort, and financial resources
necessary to meet the information
collection requirements referenced in
this section. The Department explicitly
seeks, and will consider, public
comment on its assumptions as they
relate to the PRA requirements
summarized in this section.
As discussed below, the Department
estimates a total OTP burden associated
with all information collections of
1,868.95 hours, and a total number of
burden hours for accreditation body
respondents of approximately 394.70
hours each year. The annual burden
associated with this rule and the
associated forms is therefore estimated
to be 2,263.65 hours.
1. Explanation of Estimated Annualized
Burden Hours for 42 CFR Part 8
The Department presents, in separate
tables below, burden estimates for the
annual reporting requirement for
accreditation bodies and also OTPs
pursuant to the proposed rule.
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR ACCREDITATION BODIES
Purpose
8.3(b)(1) through (11) ..........
8.3(c) ....................................
8.3(e) ...................................
8.3(f)(2) ................................
8.4(b)(1)(ii) ...........................
8.4(d)(2) ...............................
8.4(d)(3) ...............................
8.4(d)(4) ...............................
8.4(d)(5) ...............................
8.4(e) ...................................
8.6(a)(2) and (b)(3) ..............
8.6(b) ...................................
8.6(b)(1) ...............................
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 ...............................................
Revocation notification to Accredited OTPs .....................
Submission of 90-day corrective plan to SAMHSA ..........
Notification to accredited OTPs of Probationary Status ...
Subtotal ........................
...........................................................................................
8.4(b)(1)(iii) ..........................
8.4(d)(1) ...............................
lotter on DSK11XQN23PROD with PROPOSALS3
Number of
respondents
42 CFR citation
Responses/
respondent
Total
Responses
Hours/
response
Total
hours
1
2
1
1
2
1
1
1
90
2
1
2
1
90
4
6.0
1.0
0.5
0.1
1.0
6
2
0.5
9
4
2
6
10
5
20
30
1.0
0.5
20
15
6
6
6
6
12
1
1
1
75
6
5
50
6
185
1
185
450
36
30
300
72
185
1
185
0.02
0.2
0.5
0.5
0.5
0.3
10
0.3
9
7.2
15
150
36
55.5
10.0
55.5
54
......................
1,407
....................
394.70
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR OPIOID TREATMENT PROGRAMS
Number of
respondents
42 CFR citation
Purpose
8.11(b) .................................
8.11(b) .................................
Renewal of approval (SMA–162) .....................................
Relocation of Program (SMA–162) ..................................
Responses/
respondent
386
35
Total
responses
1
1
110 Public Law 105–277, 112 Stat. 2681 (October
21, 1998).
VerDate Sep<11>2014
22:09 Dec 15, 2022
Jkt 259001
PO 00000
Frm 00020
Fmt 4701
Sfmt 4702
E:\FR\FM\16DEP3.SGM
16DEP3
386
35
Hours/
response
0.15
1.17
Total
hours
57.9
40.95
77349
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR OPIOID TREATMENT PROGRAMS—Continued
Purpose
8.11(d) .................................
8.11(f) ..................................
8.11(g)(5) .............................
8.25(a) .................................
8.26(a) .................................
8.28(a) .................................
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 ......................
8.28(c) ..................................
Subtotal ........................
Total ......................
8.11(h)(2) .............................
8.11(i) ...................................
8.11(j)(1) ..............................
8.12(j)(2) ..............................
8.24 ......................................
lotter on DSK11XQN23PROD with PROPOSALS3
Number of
respondents
42 CFR citation
Total
responses
Hours/
response
Total
hours
42
30
60
1
1
1
42
30
60
1
0.25
0.1
42.00
7.50
6.00
1
1,200
1
20
1
24,000
1
0.07
1.00
1,680
10
1
10
0.25
2.5
1
20
20
0.33
6.6
2
1
2
0.25
.50
2
2
2
1
1
1
2
2
2
1.00
5.00
1.00
2.00
10.00
2.00
Appellant Review File and Written Statement ..................
2
1
2
5.00
10.00
...........................................................................................
...........................................................................................
1,775
1,829
......................
......................
24,594
26,001
....................
....................
1,868.95
2,263.65
The tables above reflect current
estimates of burden, as the proposed
rule does not effectively add or alter
new reporting requirements. The
estimates are derived from SAMHSA’s
data and are reflective of work from over
the preceding twelve months. Further to
this, the estimates of burden do not
substantially differ from previously
submitted estimates provided to The
Office of Management and Budget.
The proposed rule does not alter
reporting requirements as these have
been shown to be effective in the safe
administration of OTPs. The
accreditation system provides effective
oversight, while OTP reporting
requirements support accreditation
activities and the provision of safe
treatment. Further to this, the proposed
rule retains requirements that OTP’s and
accreditation organizations disclose
information related to patient care and
clinic policies and procedures for the
treatment of OUD with MOUD. For
example, § 8.12(e)(1) requires that a
qualifying health care practitioner
explain the facts concerning the use of
MOUD to each patient. This type of
disclosure is considered to be consistent
with common medical practice and is
not considered an additional burden.
Further, the requirement under
§ 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.
VerDate Sep<11>2014
Responses/
respondent
21:35 Dec 15, 2022
Jkt 259001
For the reasons stated in the preamble,
the Department of Health and Human
Services proposes to revise 42 CFR part
8 to read as set forth below:
■
PART 8—MEDICATIONS FOR THE
TREATMENT OF OPIOID USE
DISORDER
Subpart A—General Provisions
Sec.
8.1 Scope.
8.2 Definitions.
Subpart 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.
Frm 00021
Fmt 4701
Sfmt 4702
Expedited procedures for review of
immediate suspension.
8.29 Ex parte communications.
8.30 Transmission of written
communications by reviewing official
and calculation of deadlines.
8.31 Authority and responsibilities of the
reviewing official.
8.32 Administrative record.
8.33 Written decision.
8.34 Court review of final administrative
action; exhaustion of administrative
remedies.
Subpart E [Reserved]
Subpart 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.
PO 00000
8.28
Subpart F—Authorization To Increase
Patient Limit to 275 Patients
8.610 Practitioner eligibility requirements
for a 3-year 275-patient limit.
8.615 Definition of a qualified practice
setting.
8.620 Applying for a 275-patient limit.
8.625 Processing a 275 Request for Patient
Limit Increase.
8.630 Practitioner requirements to maintain
a 275-patient limit.
8.640 Renewal process for a 3-year 275
Request for Patient Limit Increase.
8.645 Practitioner responsibility when no
renewal request for patient limit increase
is submitted, or whose renewal request
is denied.
8.650 Suspension or revocation of the
Secretary’s approval of a practitioner’s
request for patient limit increase.
8.655 Temporary increase to treat up to 275
patients in emergency situations.
Authority: 21 U.S.C. 823; 42 U.S.C. 257a,
290aa(d), 290dd–2, 300x–23, 300x–27(a),
300y–11.
Subpart A—General Provisions
§ 8.1
Scope.
(a) This subpart and subparts B
through D of this part establish the
procedures by which the Secretary of
Health and Human Services (the
Secretary) will determine whether an
E:\FR\FM\16DEP3.SGM
16DEP3
77350
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
applicant seeking to become an Opioid
Treatment Program (OTP) is qualified
under section 303(g) of the Controlled
Substances Act (CSA) (21 U.S.C.
823(g)(1)) to dispense Medications for
Opioid Use Disorder (MOUD) in the
treatment of Opioid Use Disorder
(OUD), and establishes the Secretary’s
standards regarding the appropriate
quantities of MOUD that may be
provided for unsupervised use by
individuals undergoing such treatment
(21 U.S.C. 823(g)(1)). Under this subpart
and subparts B through D, an applicant
seeking to become an OTP must first
obtain from the Secretary or, by
delegation, from the Assistant Secretary
for Mental Health and Substance Use, a
certification that the applicant is
qualified under the Secretary’s
standards and will comply with such
standards. Eligibility for certification
will depend upon the applicant
obtaining accreditation from an
accreditation body that has been
approved by the Secretary. This subpart
and subparts B through D also establish
the procedures whereby an entity can
apply to become an approved
accreditation body, and the
requirements and general standards for
accreditation bodies to ensure that OTPs
are consistently evaluated for
compliance with the Secretary’s
standards for treatment of OUD with
MOUD.
(b) The regulations in subpart F of this
part establish the procedures and
requirements that practitioners who are
authorized to treat up to 100 patients
with OUD pursuant to a waiver obtained
under section 303(g)(2) of the CSA (21
U.S.C. 823(g)(2)), must satisfy in order
to treat up to 275 patients with
medications covered under section
303(g)(2)(C) of the CSA.
lotter on DSK11XQN23PROD with PROPOSALS3
§ 8.2
Definitions.
The following definitions apply to
this part:
Accreditation body means an
organization that has been approved by
the Secretary in this part to accredit
OTPs dispensing MOUD.
Accreditation body application means
the application filed with the Secretary
for purposes of obtaining approval as an
accreditation body, as described in
§ 8.3(b).
Accreditation elements mean the
elements or standards that are
developed and adopted by an
accreditation body and approved by the
Secretary.
Accreditation survey means an onsite
review and evaluation of an OTP by an
accreditation body for the purpose of
determining compliance with the
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
Federal opioid 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).
Additional credentialing means board
certification in Addiction Medicine or
Addiction Psychiatry by the American
Board of Addiction Medicine, the
American Board of Medical Specialties,
or the American Osteopathic
Association or certification by the
American Board of Addiction Medicine,
the American Society of Addiction
Medicine.
Approval term means the 3-year
period in which a practitioner is
approved to treat up to 275 patients
with OUD that commences when a
practitioner’s Request for Patient Limit
Increase is approved in accordance with
§ 8.625.
Behavioral health services means any
intervention carried out in a therapeutic
context at an individual, family, or
group level. Interventions may include
structured, professionally administered
clinical interventions (e.g., cognitive
behavior therapy or insight-oriented
psychotherapy) delivered in-person, or
remotely via telemedicine, which has
been shown to facilitate treatment
outcomes, or non-clinical interventions.
Care plan means an individualized
treatment and/or recovery plan that
outlines attainable treatment goals that
have been identified and agreed upon
between the patient and the OTP
clinical team, and which specifies the
services to be provided, as well as the
proposed frequency and schedule for
their provision.
Certification means the process by
which the Secretary determines that an
OTP is qualified to provide OUD
treatment under the Federal Opioid Use
Disorder treatment standards.
Certification application means the
application filed by an OTP for
purposes of obtaining certification from
the Secretary, as described in § 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
PO 00000
Frm 00022
Fmt 4701
Sfmt 4702
the OTP to address areas of nonconformance with accreditation
standards that do not involve
immediate, high-risk health and/or
safety concerns.
Continuous medication treatment
means the uninterrupted treatment for
OUD involving the dispensing and
administration of MOUD at stable
dosage levels for a period in excess of
21 days.
Covered medications means the
medications or combinations of such
medications that are covered under 21
U.S.C. 823(g)(2)(C).
Dispense means to deliver a
controlled medication to an ultimate
user by, or pursuant to, the lawful order
of, a practitioner, including the
prescribing and administering of a
controlled medication.
Diversion control plan means a set of
documented procedures that reduce the
possibility that controlled medications
will be transferred or otherwise shared
with others to whom the medication
was not prescribed or dispensed.
Emergency situation means that an
existing State, tribal, or local system for
substance use disorder services is
overwhelmed or unable to meet the
existing need for the provision of
MOUD as a direct consequence of a
clear precipitating event. This
precipitating event must have an abrupt
onset, such as: practitioner incapacity;
natural or human-caused disaster; an
outbreak associated with drug use; and
result in significant death, injury,
exposure to life-threatening
circumstances, hardship, suffering, loss
of property, or loss of community
infrastructure.
Federal Opioid Use Disorder
treatment standards means the
standards established by the Secretary
in § 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 use.
For-cause inspection means an
inspection, by the Secretary, an
accreditation body, or a State authority,
of an OTP that may be operating in
violation of Federal Opioid Use
Disorder treatment standards, may be
providing substandard treatment, may
be serving as a possible source of
diverted medications, or where patient
well-being is at risk.
Harm reduction refers to practical,
evidence-based strategies, including:
overdose education; testing and
intervention for infectious diseases,
E:\FR\FM\16DEP3.SGM
16DEP3
lotter on DSK11XQN23PROD with PROPOSALS3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
including counseling and risk
mitigation activities forming part of a
comprehensive, integrated approach to
address human immunodeficiency virus
(HIV), viral hepatitis, sexually
transmitted infections, and bacterial and
fungal infections; distribution of opioid
overdose reversal medications; linkage
to other public health services; and
connecting those who have expressed
interest in additional support to peer
services.
Individualized dose means the dose of
a medication for opioid use disorder,
ordered by an OTP practitioner and
dispensed to a patient, that sufficiently
suppresses opioid withdrawal
symptoms. Individualized doses may
also include split doses of a medication
for opioid use disorder, where such
dosing regimens are indicated.
Interim treatment means that on a
temporary basis, a patient may receive
services from an OTP, while awaiting
access to more comprehensive treatment
services. The duration of interim
treatment is limited to 180 days.
Long-term care facilities mean those
facilities that provide rehabilitative,
restorative, and/or ongoing services to
those in need of assistance with
activities of daily living. Long-term care
facilities include: extended acute care
facilities; rehabilitation centers; skilled
nursing facilities; permanent supportive
housing; assisted living facilities; and
chronic care hospitals.
Medical director means a physician,
licensed to practice medicine in the
jurisdiction in which the OTP is
located, who assumes responsibility for
all medical and behavioral health
services provided by the program,
including their administration. A
medical director may delegate specific
responsibilities to authorized program
physicians, appropriately licensed 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
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
‘‘maintenance’’ treatment as used in 21
U.S.C. 823(g)(1), and the term
‘‘withdrawal management’’ is intended
to be synonymous with the term
‘‘detoxification’’ as used in 21 U.S.C.
823(g)(1).
Medication unit means an entity that
is established as part of, but
geographically separate from, an OTP
from which appropriately licensed OTP
practitioners, contractors working on
behalf of the OTP, or community
pharmacists may dispense or administer
MOUD, collect samples for drug testing
or analysis, or provide other OTP
services. Medication units can be a
brick-and-mortar location or mobile
unit.
Nationally recognized evidence-based
guidelines mean a document produced
by a national or international medical
professional association, public health
agency, such as the World Health
Organization, or governmental body
with the aim of assuring the appropriate
use of evidence to guide individual
diagnostic and therapeutic clinical
decisions for the management of OUD
and other health conditions that are
widely recognized within the United
States.
Opioid Treatment Program or OTP
means a program engaged in OUD
treatment of individuals with MOUD
registered under 21 U.S.C. 823(g)(1).
Opioid Treatment Program
certification means the process by
which the Secretary determines that an
OTP applicant is qualified to provide
Opioid Use Disorder treatment under
the Federal Opioid Use Disorder
treatment standards described in § 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 subparts B
through D of this part, means any
individual who receives continuous
treatment or withdrawal management in
an OTP. The word patient encompasses
client, person in treatment, or any other
definition accepted by the treatment
community or those with lived
experience. For purposes of subpart F of
PO 00000
Frm 00023
Fmt 4701
Sfmt 4702
77351
this part, patient means any individual
who is dispensed or prescribed covered
medications by a practitioner.
Patient limit means the maximum
number of individual patients that a
practitioner may dispense or prescribe
covered medications to at any one time.
Physical and behavioral health
services include services such as
medical and psychiatric screening,
assessments, evaluations, examinations,
and interventions, counseling, health
education, peer support services, and
social services (e.g., vocational and
educational guidance, employment
training), that are intended to help
patients in OTPs achieve and sustain
remission and recovery.
Practitioner, for purposes of this
subpart and subparts B through D of this
part, means a physician, physician
assistant, nurse practitioner, clinical
nurse specialist, certified registered
nurse anesthetist, or certified nurse
midwife who is appropriately licensed
by a State to prescribe and/or dispense
medications for opioid use disorder
within an OTP. The term practitioner,
for purposes of subpart F of this part,
means a physician, physician assistant,
nurse practitioner, clinical nurse
specialist, certified registered nurse
anesthetist, or certified nurse midwife
who is appropriately licensed by a State
to prescribe and/or dispense schedule
III, IV, and V medications for opioid use
disorder, and who possesses a waiver
under 21 U.S.C. 823(g)(2).
Practitioner incapacity means the
inability of a practitioner as a result of
an involuntary event to physically or
mentally perform the tasks and duties
required to provide OUD treatment in
accordance with nationally recognized
evidence-based guidelines.
Program sponsor means the person
named in the application for
certification described in § 8.11(b) as
responsible for the operation of the OTP
and who assumes responsibility for all
its employees, including any
practitioners, agents, or other persons
providing medical, behavioral health, or
social services at the program or any of
its medication units. The program
sponsor need not be a licensed
physician but shall ensure that an
actively licensed physician occupies the
position of medical director within an
OTP.
Recovery support services means:
(1) Recovery is the process of change
through which people improve their
health and wellness, live self-directed
lives, and strive to reach their full
potential.
(2) Recovery support services can
include, but are not limited to,
community-based recovery housing,
E:\FR\FM\16DEP3.SGM
16DEP3
77352
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS3
peer recovery support services, social
support, linkage to and coordination
among allied service providers and a
full range of human services that
facilitate recovery and wellness
contributing to an improved quality of
life. The services extend the continuum
of care by strengthening and
complementing substance use disorder
(SUD) treatment interventions in
different settings and stages.
Split dosing means dispensing of a
single dose of MOUD as separate
portions to be taken within a 24-hour
period. Split dosing is indicated among,
but not limited to, those patients who:
possess a genetic variant which
increases methadone metabolism;
concurrently use other medications or
alcohol that also induce hepatic
enzymes leading to more rapid
metabolism of methadone; who are
pregnant; or for whom methadone or
buprenorphine are being used to treat a
concurrent pain indication in addition
to the diagnosis of OUD. This leads to
more stable, steady-state medication
levels.
State Opioid Treatment Authority
(SOTA) is the agency designated by the
Governor of a State, or other appropriate
official designated by the Governor, to
exercise the responsibility and authority
within the State or Territory for
governing the treatment of OUD with
MOUD in OTPs.
Telehealth or telemedicine is the
delivery and facilitation of health and
health-related services including
medical care, counselling, practitioner,
provider and patient education, health
information services, and self-care via
telecommunications and digital
communication technologies. This
includes Health Insurance Portability
and Accountability Act (HIPAA)compliant video and audio-only
communication platforms.
Withdrawal management means the
dispensing of a MOUD in decreasing
doses to an individual to alleviate
adverse physical effects incident to
withdrawal from the continuous or
sustained use of an opioid and as a
method of bringing the individual to an
opioid-free state within such period.
Long-term withdrawal management
refers to the process of medication
tapering that exceeds 30 days.
Subpart B—Accreditation of Opioid
Treatment Programs
§ 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
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
as defined by the Federally Recognized
Indian Tribe List Act of 1994, that are
capable of meeting the requirements of
this part may apply for approval as an
accreditation body.
(b) Application for initial approval.
Electronic copies of an accreditation
body application form [SMA–167] shall
be submitted to: https://
dpt2.samhsa.gov/sma163/.
Accreditation body applications shall
include the following information and
supporting documentation:
(1) Name, address, and telephone
number of the applicant and a
responsible official for the accreditation
body. The application shall be signed by
the responsible official;
(2) Evidence of the nonprofit status of
the applicant (i.e., of fulfilling Internal
Revenue Service requirements as a
nonprofit organization) if the applicant
is not a State or territorial governmental
entity, Indian Tribe, or political
subdivision;
(3) A set of the accreditation elements
or standards and a detailed discussion
showing how the proposed
accreditation elements or standards will
ensure that each OTP surveyed by the
applicant is qualified to meet or is
meeting each of the Federal opioid
treatment standards set forth in § 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
PO 00000
Frm 00024
Fmt 4701
Sfmt 4702
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 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
E:\FR\FM\16DEP3.SGM
16DEP3
lotter on DSK11XQN23PROD with PROPOSALS3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
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.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
(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 either
require and monitor corrective action or
shall suspend or revoke accreditation of
the OTP, as appropriate based on the
significance of the deficiencies.
(i) Accreditation bodies shall either
not accredit or shall revoke the
accreditation of any OTP that
substantially fails to meet the Federal
Opioid Use Disorder treatment
standards.
(ii) Accreditation bodies shall notify
the Secretary as soon as possible but in
no case longer than 48 hours after
becoming aware of any practice or
condition in an OTP that may pose a
serious risk to public health or safety or
patient care.
(iii) If an accreditation body
determines that an OTP is meeting the
Federal Opioid Use Disorder treatment
standards, as defined in § 8.12, but is
not meeting one or more accreditation
elements within 60 days of survey
completion, the accreditation body shall
determine the necessary corrective
PO 00000
Frm 00025
Fmt 4701
Sfmt 4702
77353
measures to be taken by the OTP,
establish a schedule for implementation
of such measures not to exceed 60 days,
and notify the OTP in writing that it
must implement such measures within
the specified schedule in order to
ensure continued accreditation. The
accreditation body shall verify that the
necessary corrective measures are
implemented by the OTP within the
schedule specified and that all
accreditation elements are met within
the specified schedule. Within 60 days
after the specified schedule for
implementation, the accreditation body
will notify the Secretary, in writing,
whether or not the OTP has completed
the corrective measures.
(2) Nothing in this part shall prevent
accreditation bodies from granting
accreditation, contingent on the
implementation of programmatic or
performance changes, to OTPs with less
substantial violations. Less substantial
violations refers to non-conformance
with accreditation standards that do not
involve immediate, high-risk health and
safety concerns. Such accreditation
shall not exceed 12 months during
which time a resurvey or reinspection
must occur to determine whether the
applicable changes have been
implemented. OTPs that have been
granted such accreditation must have
their accreditation revoked if they fail to
implement the applicable changes upon
resurvey or reinspection.
(c) Recordkeeping. (1) Accreditation
bodies shall maintain, and make
available as requested by the Secretary,
records of their accreditation activities
for at least 5 years from the creation of
the record. Such records must contain
sufficient detail to support each
accreditation decision made by the
accreditation body.
(2) Accreditation bodies shall
establish procedures to protect
confidential information collected or
received in their role as accreditation
bodies that are consistent with, and that
are designed to ensure compliance with,
all Federal and State laws, including 42
CFR part 2.
(i) Information collected or received
for the purpose of carrying out
accreditation body responsibilities shall
not be used for any other purpose or
disclosed, other than to the Secretary or
its duly designated representatives,
unless otherwise required by law or
with the consent of the OTP.
(ii) Nonpublic information that the
Secretary shares with the accreditation
body concerning an OTP shall not be
further disclosed except with the
written permission of the Secretary.
(d) Reporting. (1) Accreditation bodies
shall provide to the Secretary any
E:\FR\FM\16DEP3.SGM
16DEP3
lotter on DSK11XQN23PROD with PROPOSALS3
77354
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
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
§ 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
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
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
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
PO 00000
Frm 00026
Fmt 4701
Sfmt 4702
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.
(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
E:\FR\FM\16DEP3.SGM
16DEP3
lotter on DSK11XQN23PROD with PROPOSALS3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
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 § 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.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
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(g)(1)) to dispense
MOUD in the treatment of OUD. An
OTP must be determined to be qualified
under section 303(g)(1) of the Controlled
Substances Act, and must be
determined to be qualified by the
Attorney General under section
303(g)(1), to be registered by the
Attorney General to dispense MOUD to
individuals for treatment of OUD.
(2) To obtain certification from the
Secretary, an OTP must meet the
Federal Opioid Use Disorder treatment
standards in § 8.12, must be the subject
of a current, valid accreditation by an
accreditation body or other entity
designated by the Secretary, and must
comply with any other conditions for
certification established by the
Secretary.
(3) OTPs are expected to maintain
certification with the Secretary and to
comply with any other conditions for
certification established by the
Secretary. Certification shall be granted
for a term not to exceed 3 years, except
that certification may be renewed
during the final certification year if the
OTP applies for certification renewal in
accordance with the steps outlined in
paragraph (a)(4) of this section.
(4) OTPs who satisfy the criteria for
certification under this section may
apply for renewal of their certification.
OTPs are expected to apply for
certification renewal during the final
year of the OTP’s certification period.
OTPs should take steps to ensure that
administrative tasks associated with
renewal are completed before the OTP’s
certification expires. OTPs may apply
for certification renewal in accordance
with the procedures as outlined in
paragraph (b) of this section. If an OTP
anticipates any delays in routine
certification renewal, an extension may
be requested by submitting to the
Secretary a statement justifying the
extension in accordance with paragraph
(e) of this section.
(5) OTPs that are certified and are
seeking certification renewal, and who
have been granted accreditation for one
year by an accreditation body as
provided under § 8.4(b)(1)(iii), may
receive a conditional certification for 1
year unless the Secretary determines
that such conditional certification
PO 00000
Frm 00027
Fmt 4701
Sfmt 4702
77355
would adversely affect patient health.
An OTP must obtain a standard 3-year
accreditation, as described in paragraph
(a)(3) of this section, within the 1-year
conditional certification period. If
standard accreditation is not obtained
by the OTP within the 1-year
conditional certification period, the
OTP’s conditional certification will
lapse, and the Attorney General will be
notified that the OTP’s registration
should be revoked.
(6) OTPs whose certification has
expired, and who seek re-certification,
will be considered ‘‘new’’ programs and
will be required to apply for provisional
certification in accordance with
paragraph (d) of this section.
(b) Application for initial or renewal
certifications and re-certification.
Applications for certification must be
submitted by the OTP using form SMA–
162. The application for initial or
renewal of certification shall include, as
determined by the Secretary:
(1) A description of the current
accreditation status of the OTP;
(2) A description of the organizational
structure of the OTP;
(3) The names of the persons
responsible for the OTP;
(4) The addresses of the OTP and of
each medication unit or other facility
under the of the OTP;
(5) The sources of funding for the OTP
and the name and address of each
governmental entity that provides such
funding;
(6) A statement that the OTP will
comply with the conditions of
certification set forth in paragraph (g) of
this section; and
(7) The application shall be signed by
the program sponsor who shall certify
that the information submitted in the
application is truthful and accurate.
(8) Applications for re-certification
shall include an explanation of why the
OTP’s most recent certification expired
and information regarding the schedule
for an accreditation survey.
(c) Action on application. (1)
Following the Secretary’s receipt of an
application for certification of an OTP,
and after consultation with the
appropriate State authority regarding
the qualifications of the applicant, the
Secretary may grant the application for
certification, or renew an existing
certification, if the Secretary determines
that the OTP has satisfied the
requirements for certification or renewal
of certification in this section.
(2) The Secretary may deny the
application if the Secretary determines
that:
(i) The application for certification is
deficient in any respect;
E:\FR\FM\16DEP3.SGM
16DEP3
lotter on DSK11XQN23PROD with PROPOSALS3
77356
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
(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 has applied for
accreditation, the date on which the
OTP applied for accreditation, the dates
of any accreditation surveys that have
taken place or are expected to take
place, and the expected schedule for
completing the accreditation process.
Provisional certification for up to 1 year
will be granted, following receipt of the
information described in this paragraph
(d), unless the Secretary determines that
patient health would be adversely
affected by the granting of provisional
certification.
(e) Requirements for certification. (1)
OTPs shall comply with all pertinent
State laws and regulations. Nothing in
this part is intended to limit the
authority of State and, as appropriate,
local governmental entities to regulate
the use of MOUD in the treatment of
OUD. The provisions of this section
requiring compliance with requirements
imposed by State law, or the submission
of applications or reports required by
the State authority, do not apply to
OTPs operated directly by the
Department of Veterans Affairs, the
Indian Health Service, or any other
department or agency of the United
States. Federal agencies operating OTPs
have agreed to cooperate voluntarily
with State agencies by granting
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
permission on an informal basis for
designated State representatives to visit
Federal OTPs and by furnishing a copy
of Federal reports to the State authority,
including the reports required under
this section.
(2) OTPs shall allow, in accordance
with Federal controlled substances laws
and Federal confidentiality laws,
inspections and surveys by duly
authorized employees of the Department
of Health and Human Services or
Substance Abuse and Mental Health
Services Administration (SAMHSA), by
accreditation bodies, by the DEA, and
by authorized employees of any relevant
State or Federal governmental authority.
(3) Disclosure of patient records
maintained by an OTP is governed by
the provisions of 42 CFR part 2 and 45
CFR parts 160 and 164, and every
program must comply with these
regulations, as applicable. Records on
the receipt, storage, and distribution of
MOUD are also subject to inspection
under Federal controlled substances
laws and under the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321 et
seq.). Federally sponsored treatment
programs are subject to applicable
Federal confidentiality statutes.
(4) A treatment program or
medication unit or any part thereof,
including any facility or any individual,
shall permit a duly authorized employee
of the Department of Health and Human
Services or SAMHSA to have access to
and to copy all records on the use of
MOUD in accordance with the
provisions of 42 CFR part 2.
(5) OTPs shall notify the Secretary in
writing within 3 weeks of any
replacement or other change in the
status of the program sponsor or
medical director.
(6) OTPs shall comply with all
regulations enforced by the DEA under
21 CFR chapter II, and must be
registered by the DEA before
administering or dispensing MOUD.
(7) OTPs must operate in accordance
with Federal Opioid Use Disorder
treatment standards and approved
accreditation elements.
(f) Conditions for interim treatment
program approval. (1) Before a public or
nonprofit private OTP may provide
interim treatment, the program must
receive the approval of both the
Secretary and the SOTA of the State in
which the OTP operates.
(2) Before the Secretary may grant
such approval, the OTP must provide
the Secretary with documentation from
the SOTA of the State in which the OTP
operates demonstrating that:
(i) Such officer does not object to the
providing of interim treatment in the
State;
PO 00000
Frm 00028
Fmt 4701
Sfmt 4702
(ii) The OTP seeking to provide such
treatment is unable to provide access for
patients in a public or nonprofit private
comprehensive treatment program
within a reasonable geographic area
within 14 days of the time patients seek
treatment for OUD;
(iii) The authorization of the OTP to
provide interim treatment will not
otherwise reduce the capacity of
comprehensive treatment programs in
the State to admit individuals (relative
to the date on which such officer so
certifies); and
(iv) OTPs providing interim treatment
will arrange for each individual’s
transfer to a comprehensive treatment
program no later than 180 days from the
date on which each individual first
requested treatment. Individuals
enrolled in interim treatment shall not
be discharged without the approval of
an OTP practitioner, which is to be
documented in the patient record, while
awaiting transfer to a comprehensive
treatment program.
(3) The Secretary will provide notice
to the OTP denying or approving the
request to provide interim treatment.
The OTP shall not provide such
treatment until it has received such
notice from the Secretary.
(g) Exemptions. An OTP may, at the
time of application for certification or
any time thereafter, request from the
Secretary exemption from the regulatory
requirements set forth under this section
and § 8.12. An example of a case in
which an exemption might be granted
would be for a private practitioner who
wishes to treat a limited number of
patients in a non-metropolitan area with
few physicians and no OUD treatment
services geographically accessible, and
requests exemption from some of the
staffing and service standards. The OTP
shall support the rationale for the
exemption with thorough
documentation, to be supplied in an
appendix to the initial application for
certification or in a separate submission.
The Secretary will approve or deny such
exemptions at the time of application, or
any time thereafter, if appropriate. The
Secretary shall consult with the
appropriate State authority prior to
taking action on an exemption request.
(h) Medication units, long-term care
facilities and hospitals. (1) Certified
OTPs may establish medication units
that are authorized to dispense MOUD.
Before establishing a medication unit, a
certified OTP must notify the Secretary
by submitting form SMA–162. The OTP
must also comply with the provisions of
21 CFR part 1300 before establishing a
medication unit. Medication units shall
comply with all pertinent State laws
and regulations.
E:\FR\FM\16DEP3.SGM
16DEP3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
(2) Specifically, any services that are
provided in an OTP may be provided in
the medication unit, assuming
compliance with all applicable Federal,
State, and local law, and the use of units
that provide appropriate privacy and
have adequate space.
(3) Certification as an OTP under this
part will not be required for the
continuous medication treatment or
withdrawal management of a patient
who is admitted to a hospital or longterm care facility for the treatment of
medical conditions other than OUD and
who requires medication continuity or
withdrawal management during the
period of their stay in that long-term
care facility when such treatment is
permitted under applicable Federal law.
The term ‘‘long-term care facility’’ is
defined in § 8.2. Nothing in this section
is intended to relieve long-term care
facilities from the obligation to obtain
registration from the Attorney General,
as appropriate, under section 303(g) of
the Controlled Substances Act.
lotter on DSK11XQN23PROD with PROPOSALS3
§ 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
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
carrying out the diversion control
measures and functions described in the
DCP.
(d) Staff credentials. Each person
engaged in the treatment of OUD must
have sufficient education, training, and
experience, or any combination thereof,
to enable that person to perform the
assigned functions. All qualifying
practitioners and other licensed/
certified health care providers,
including counselors, must comply with
the credentialing and maintenance of
licensure and/or certification
requirements of their respective
professions.
(e) Patient admission criteria—(1)
Comprehensive treatment. An OTP shall
maintain current procedures designed to
ensure that patients are admitted to
treatment by qualified personnel who
have determined, using accepted
medical criteria, that: The person meets
diagnostic criteria for a moderate to
severe OUD; the individual has an
active moderate to severe OUD, or OUD
in remission, or is at high risk for
recurrence or overdose. Such decisions
must be appropriately documented in
the patient’s clinical record. In addition,
a qualifying health care practitioner
shall ensure that each patient
voluntarily chooses treatment with
MOUD and that all relevant facts
concerning the use of MOUD are clearly
and adequately explained to the patient,
and that each patient provides informed
consent to treatment.
(2) Comprehensive treatment for
persons under age 18. Except in States
where State law grants persons under 18
years of age the ability to consent to
OTP treatment without the consent of
another, no person under 18 years of age
may be admitted to OTP treatment
unless a parent, legal guardian, or
responsible adult designated by the
relevant State authority consents in
writing to such treatment.
(3) Withdrawal management. An OTP
shall maintain current procedures that
are designed to ensure that those
patients who choose to taper from
MOUD are provided the opportunity to
do so with informed consent and at a
mutually agreed-upon rate that
minimizes taper-related risks. Such
consent must be documented in the
clinical record by the treating
practitioner.
(f) Required services—(1) General.
OTPs shall provide adequate medical,
counseling, vocational, educational, and
other screening, assessment, and
treatment services to meet patient
needs, with the combination and
frequency of services tailored to each
individual patient based on an
individualized assessment and the
PO 00000
Frm 00029
Fmt 4701
Sfmt 4702
77357
patient’s care plan that was created after
shared decision making between the
patient and the clinical team. These
services must be available at the
primary facility, except where the
program sponsor has entered into a
documented agreement with a private or
public agency, organization,
practitioner, or institution to provide
these services to patients enrolled in the
OTP. The program sponsor, in any
event, must be able to document that
these services are fully and reasonably
available to patients.
(2) Initial medical examination. (i)
OTPs shall require each patient to
undergo an initial medical examination.
The initial medical examination is
comprised of two parts:
(A) A screening examination to ensure
that the patient meets criteria for
admission and that there are no
contraindications to treatment with
MOUD; and
(B) A full history and examination, to
determine the patient’s broader health
status, with lab testing.
(ii) Assuming no contraindications, a
patient may commence treatment with
MOUD after the screening examination
has been completed. Both the screening
examination and full examination must
be completed by an appropriately
licensed practitioner. If the licensed
practitioner is not an OTP practitioner,
the screening examination must be
completed no more than seven days
prior to OTP admission. Where the
examination is performed outside of the
OTP, the written results and narrative of
the examination, as well as available lab
testing results, must be transmitted,
consistent with applicable privacy laws,
to the OTP, and verified by an OTP
practitioner.
(iii) A full in person physical
examination, including the results of
serology and other tests, such as a
pregnancy test, must be completed
within 14 calendar days following a
patient’s admission to the OTP. The full
exam can be completed by a non-OTP
practitioner, if the exam is verified by a
licensed OTP practitioner as being true
and accurate and transmitted in
accordance with applicable privacy
laws.
(iv) Serology testing and other testing
as deemed medically appropriate by the
licensed OTP practitioner based on the
screening or full history and
examination, drawn not more than 30
days prior to admission to the OTP, may
form part of the full history and
examination.
(v) The screening and full
examination may be completed via
telehealth for those patients being
admitted for treatment with either
E:\FR\FM\16DEP3.SGM
16DEP3
lotter on DSK11XQN23PROD with PROPOSALS3
77358
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
buprenorphine or methadone, if a
qualified practitioner or primary care
provider, determines that an adequate
evaluation of the patient can be
accomplished via telehealth. When
using telehealth, the following caveats
apply:
(A) In evaluating patients for
treatment with schedule II medications
(such as Methadone), audio-visual
telehealth platforms must be used,
except when not available to the patient.
When not available, it is acceptable to
use audio-only devices, but only when
the patient is in the presence of a
licensed practitioner who is registered
to prescribe (including dispense)
controlled medications.
(B) In evaluating patients for
treatment with schedule III medications
(such as Buprenorphine) or medications
not classified as a controlled medication
(such as Naltrexone), audio-visual or
audio only platforms may be used.
(3) Special services for pregnant
patients. OTPs must maintain current
policies and procedures that reflect the
special needs and priority for treatment
admission of patients with OUD who
are pregnant. Pregnancy should be
confirmed. Evidence-based treatment
protocols for the pregnant patient, such
as split dosing regimens, may be
instituted after assessment by an OTP
practitioner and documentation that
confirms the clinical appropriateness of
such an evidence-based treatment
protocol. Prenatal care and other sex
specific services, including reproductive
health services, for pregnant and
postpartum patients must be provided
and documented either by the OTP or
by referral to appropriate healthcare
practitioners. Specific services,
including reproductive health services,
for pregnant and postpartum patients
must be provided and documented
either by the OTP or by referral to
appropriate healthcare practitioners.
(4) Initial and periodic physical and
behavioral health assessment services.
(i) Each patient admitted to an OTP
shall be given a physical and behavioral
health assessment, which includes but
is not limited to screening for imminent
risk of harm to self or others, within 14
calendar days following admission, and
periodically by appropriately licensed/
credentialed personnel. These
assessments must address the need for
and/or response to treatment, adjust
treatment interventions, including
MOUD, as necessary, and provide a
patient-centered plan of care. The full,
initial psychosocial assessment must be
completed within 14 calendar days of
admission and include preparation of a
care plan that includes the patient’s
goals and mutually agreed-upon actions
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
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 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,
PO 00000
Frm 00030
Fmt 4701
Sfmt 4702
education, and employment services for
patients who request such services or
for whom these needs have been
identified and mutually agreed-upon as
beneficial by the patient and program
staff.
(6) Drug testing services. OTPs must
provide drug tests that have received the
Food and Drug Administration’s (FDA)
marketing authorization for commonly
used and misused substances that may
impact patient safety, recovery, or
otherwise complicate substance use
disorder treatment, at a frequency that is
in accordance with generally accepted
clinical practice and as indicated by a
patient’s response to and stability in
treatment, but no fewer than eight
random drug tests per year patient,
allowing for extenuating circumstances
at the individual patient level.
(g) Recordkeeping and patient
confidentiality. (1) OTPs shall establish
and maintain a recordkeeping system
that is adequate to document and
monitor patient care. This system is
required to comply with all Federal and
State reporting requirements relevant to
MOUD approved for use in treatment of
OUD. All records are required to be kept
confidential in accordance with all
applicable Federal and State
requirements.
(2) OTPs shall include, as an essential
part of the recordkeeping system,
documentation in each patient’s record
that the OTP made a good faith effort to
determine whether the patient is
enrolled in any other OTP. A patient
enrolled in an OTP shall not be
permitted to obtain treatment in any
other OTP except in circumstances
involving an inability to access care at
the patient’s OTP of record. Such
circumstances include, but are not
limited to, travel for work or family
events, temporary relocation, or an
OTP’s temporary closure. If the medical
director or program practitioner of the
OTP in which the patient is enrolled
determines that such circumstances
exist, the patient may seek treatment at
another OTP, provided the justification
for the particular circumstances are
noted in the patient’s record both at the
OTP in which the patient is enrolled
and at the OTP that will provide the
MOUD.
(h) Medication administration,
dispensing, and use. (1) OTPs must
ensure that MOUD are administered or
dispensed only by a practitioner
licensed under the appropriate State law
and registered under the appropriate
State and Federal laws to administer or
dispense MOUD, or by an agent of such
a practitioner, supervised by and under
the order of the licensed practitioner
E:\FR\FM\16DEP3.SGM
16DEP3
lotter on DSK11XQN23PROD with PROPOSALS3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
and if consistent with Federal and State
law.
(2) OTPs shall use only those MOUD
that are approved by the Food and Drug
Administration under section 505 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) for use in the treatment
of OUD. In addition, OTPs who are fully
compliant with the protocol of an
investigational use of a drug and other
conditions set forth in the application
may administer a drug that has been
authorized by the Food and Drug
Administration under an investigational
new drug application under section
505(i) of the Federal Food, Drug, and
Cosmetic Act for investigational use in
the treatment of OUD. Currently the
following MOUD will be considered to
be approved by the Food and Drug
Administration for use in the treatment
of OUD:
(i) Methadone;
(ii) Buprenorphine and
buprenorphine combination products
that have been approved for use in the
treatment of OUD; and
(iii) Naltrexone.
(3) OTPs shall maintain current
procedures that are adequate to ensure
that the following dosage form and
initial dosing requirements are met:
(i) Methadone shall be administered
or dispensed only in oral form and shall
be formulated in such a way as to
reduce its potential for parenteral
misuse.
(ii) For each new patient enrolled in
a program, the initial dose of methadone
shall be individually determined, and is
not to exceed 30 milligrams, and the
total dose for the first day shall not
exceed 40 milligrams. Should this not
be sufficient to suppress symptoms of
withdrawal, the OTP practitioner
licensed under the appropriate State law
and registered under the appropriate
State and Federal laws to administer or
dispense MOUD, must document in the
patient’s record a specific rationale
indicating that 40 milligrams did not
adequately suppress opioid withdrawal
symptoms, and that a higher dose was
clinically indicated and thus provided
to the patient.
(4) OTPs shall maintain current
procedures adequate to ensure that each
MOUD used by the program is
administered and dispensed in
accordance with its FDA approved
product labeling. The program must
ensure that any significant deviations
from the approved labeling, including
deviations with regard to dose,
frequency, or the conditions of use
described in the approved labeling, are
specifically documented in the patient’s
record.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
(i) Unsupervised or ‘‘take home’’
medication doses. Unsupervised or
‘‘take home’’ medication doses may be
provided under the following
circumstances:
(1) Any patient in comprehensive
treatment may receive their
individualized take home doses as
ordered for days that the clinic is closed
for business, including one weekend
day (e.g., Sunday) and State and Federal
holidays, no matter their length of time
in treatment.
(2) Treatment program decisions on
dispensing MOUD to patients for
unsupervised use beyond that set forth
in paragraph (i)(1) of this section shall
be determined by an appropriately
licensed OTP medical practitioner or
the medical director. In determining
which patients may receive
unsupervised medication doses, the
medical director or program medical
practitioner shall consider, among other
pertinent factors that indicate that the
therapeutic benefits of unsupervised
doses outweigh the risks, the following
criteria:
(i) Absence of active substance use
disorders, other physical or behavioral
health conditions that increase the risk
of patient harm as it relates to the
potential for overdose, or the ability to
function safely;
(ii) Regularity of attendance for
supervised medication administration;
(iii) Absence of serious behavioral
problems that endanger the patient, the
public or others;
(iv) Absence of known recent
diversion activity;
(v) Whether take home medication
can be safely transported and stored;
and
(vi) Any other criteria that the
medical director or medical practitioner
considers relevant to the patient’s safety
and the public’s health.
(3) Such determinations and the basis
for such determinations consistent with
the criteria outlined in paragraph (i)(2)
of this section shall be documented in
the patient’s medical record. If it is
determined that a patient is safely able
to manage unsupervised doses of
MOUD, the dispensing restrictions set
forth in paragraphs (i)(3)(i) through (iii)
of this section apply. The dispensing
restrictions set forth in paragraphs
(i)(3)(i) through (iii) of this section do
not apply to buprenorphine and
buprenorphine products listed under
paragraph (h)(2)(ii) of this section.
(i) During the first 14 days of
treatment, the take home supply
(beyond that of paragraph (i)(1) of this
section) is limited to 7 days. It remains
within the OTP practitioner’s discretion
to determine the number of take home
PO 00000
Frm 00031
Fmt 4701
Sfmt 4702
77359
doses up to 7 days, but decisions must
be based on the criteria listed in
paragraph (i)(2) of this section. The
rationale underlying the decision to
provide unsupervised doses of
methadone must be documented in the
patient’s clinical record, consistent with
paragraph (g)(2) of this section.
(ii) From 15 days of treatment, the
take home supply (beyond that of
paragraph (i)(1) of this section) is
limited to 14 days. It remains within the
OTP practitioner’s discretion to
determine the number of take home
doses up to 14 days, but this
determination must be based on the
criteria listed in paragraph (i)(2) of this
section. The rationale underlying the
decision to provide unsupervised doses
of methadone must be documented in
the patient’s clinical record, consistent
with paragraph (g)(2) of this section.
(iii) From 31 days of treatment, the
take home supply (beyond that of
paragraph (i)(1) of this section) provided
to a patient is not to exceed 28 days. It
remains within the OTP practitioner’s
discretion to determine the number of
take home doses up to 28 days, but this
determination must be based on the
criteria listed in paragraph (i)(2) of this
section. The rationale underlying the
decision to provide unsupervised doses
of methadone must be documented in
the patient’s clinical record, consistent
with paragraph (g)(2) of this section.
(4) OTPs must maintain current
procedures adequate to identify the theft
or diversion of take home medications,
including labeling containers with the
OTP’s name, address, and telephone
number. Programs also must ensure that
each individual take home dose is
packaged in a manner that is designed
to reduce the risk of accidental
ingestion, including child-proof
containers (see Poison Prevention
Packaging Act, Pub. L. 91–601 (15
U.S.C. 1471 et seq.)). Programs must
provide education to each patient on:
Safely transporting medication from the
OTP to their place of residence; and the
safe storage of take home doses at the
individual’s place of residence,
including child and household safety
precautions. The provision of this
education should be documented in the
patient’s clinical record.
(j) Interim treatment. (1) The program
sponsor of a public or nonprofit, private
OTP may admit an individual, who is
eligible for admission to comprehensive
treatment, into interim treatment if
comprehensive services are not readily
available within a reasonable geographic
area and within 14 days of the
individual’s seeking treatment. At least
two drug tests shall be obtained from
patients during the maximum of 180
E:\FR\FM\16DEP3.SGM
16DEP3
77360
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
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 § 8.11(h).
(4) All requirements for
comprehensive treatment in this section
apply to interim treatment with the
following exceptions:
(i) A primary counselor is not
required to be assigned to the patient,
but crisis services should be available;
(ii) Interim treatment cannot be
provided for longer than 180 days in
any 12-month period;
(iii) By day 120, a plan for continuing
treatment beyond 180 days must be
created, and documented in the
patient’s clinical record; and
(iv) Formal counseling, vocational
training, employment, and educational
services described in paragraphs (f)(4)
and (f)(5)(i) and (iii) of this section are
not required to be offered to the patient.
However, information pertaining to
locally available, community-based
resources for ancillary services should
be made available to individual patients
in interim treatment.
lotter on DSK11XQN23PROD with PROPOSALS3
§ 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
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
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
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 guilty of
misrepresentation in obtaining the
certification;
(2) Has failed to comply with the
Federal Opioid Use Disorder treatment
standards in any respect;
(3) Has failed to comply with
reasonable requests from the Secretary
or from an accreditation body for
records, information, reports, or
materials that are necessary to
determine the continued eligibility of
the OTP for certification or continued
compliance with the Federal Opioid Use
Disorder treatment standards; or
(4) Has refused a reasonable request of
a duly designated inspector, DEA
PO 00000
Frm 00032
Fmt 4701
Sfmt 4702
Inspector, State Inspector, or
accreditation body representative for
permission to inspect the program or the
program’s operations or its records.
(b) Suspension. Whenever the
Secretary has reason to believe that
revocation may be required and that
immediate action is necessary to protect
public health or safety, the Secretary
may immediately suspend the
certification of an OTP, and notify the
Attorney General that the OTP’s
registration should be suspended, before
holding a hearing under this subpart.
The Secretary may immediately
suspend as well as propose revocation
of the certification of an OTP before
holding a hearing under this subpart if
the Secretary makes a finding described
in paragraph (a) of this section and also
determines that:
(1) The failure to comply with the
Federal Opioid Use Disorder treatment
standards presents an imminent danger
to the public health or safety;
(2) The refusal to permit inspection
makes immediate suspension necessary;
or
(3) There is reason to believe that the
failure to comply with the Federal
Opioid Use Disorder treatment
standards was intentional or was
associated with fraud.
(c) Written notification. In the event
that the Secretary suspends the
certification of an OTP in accordance
with paragraph (b) of this section or
proposes to revoke the certification of
an OTP in accordance with paragraph
(a) of this section, the Secretary shall
promptly provide the sponsor of the
OTP with written notice of the
suspension or proposed revocation by
facsimile transmission, personal service,
commercial overnight delivery service,
or certified mail, return receipt
requested. Such notice shall state the
reasons for the action and shall state
that the OTP may seek review of the
action in accordance with the
procedures in this subpart.
(d) Procedure. (1) If the Secretary
suspends certification in accordance
with paragraph (b) of this section:
(i) The Secretary will immediately
notify DEA that the OTP’s registration
should be suspended under 21 U.S.C.
824(d); and
(ii) The Secretary will provide an
opportunity for a hearing under this
subpart.
(2) Suspension of certification under
paragraph (b) of this section shall
remain in effect until the agency
determines that:
(i) The basis for the suspension
cannot be substantiated;
E:\FR\FM\16DEP3.SGM
16DEP3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
(ii) Violations of required standards
have been corrected to the agency’s
satisfaction; or
(iii) The OTP’s certification shall be
revoked.
the scientific and technical evidence
and other information submitted by the
appellant and respondent on the reasons
for the suspension and proposed
revocation.
§ 8.15
§ 8.23 Limitation on issues subject to
review.
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 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 an
opportunity for a review of the
suspension or proposed revocation.
(c) The Secretary has notified an
accreditation body of an adverse action
taken regarding withdrawal of approval
of the accreditation body under the
regulations in subpart A of this part; and
(d) The accreditation body has, within
30 days of the date of the notification,
requested in writing an opportunity for
a review of the adverse action.
lotter on DSK11XQN23PROD with PROPOSALS3
§ 8.22
Definitions.
The following definitions apply to
this subpart:
Appellant means:
(1) The OTP which has been notified
of its suspension or proposed revocation
of its certification under the regulations
of this part and has requested a review
of the suspension or proposed
revocation; or
(2) The accreditation body which has
been notified of adverse action
regarding withdrawal of approval under
the regulations of this subpart and has
requested a review of the adverse action.
Respondent means SAMHSA.
Reviewing official means the person
or persons designated by the Secretary
who will review the suspension or
proposed revocation. The reviewing
official may be assisted by one or more
Department of Health and Human
Services (HHS) officers or employees or
consultants in assessing and weighing
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
The scope of review shall be limited
to the facts relevant to any suspension,
or proposed revocation, or adverse
action, the necessary interpretations of
the facts, the regulations in this subpart,
and other relevant law.
§ 8.24 Specifying who represents the
parties.
The appellant’s request for review
shall specify the name, address, and
phone number of the appellant’s
representative. In its first written
submission to the reviewing official, the
respondent shall specify the name,
address, and phone number of the
respondent’s representative.
§ 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
PO 00000
Frm 00033
Fmt 4701
Sfmt 4702
77361
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.
§ 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
E:\FR\FM\16DEP3.SGM
16DEP3
lotter on DSK11XQN23PROD with PROPOSALS3
77362
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
initiative or at the request of the
respondent.
(b) Presiding official. The reviewing
official or designee will be the presiding
official responsible for managing the
oral presentations.
(c) Preliminary conference. The
presiding official may hold a prehearing
conference (usually a telephone
conference call) to consider any of the
following: Simplifying and clarifying
issues; stipulations and admissions;
limitations on evidence and witnesses
that will be presented at the hearing;
time allotted for each witness and the
hearing altogether; scheduling the
hearing; and any other matter that will
assist in the review process. Normally,
this conference will be conducted
informally and off the record; however,
the presiding official may, at the
presiding official’s discretion, produce a
written document summarizing the
conference or transcribe the conference,
either of which will be made a part of
the record.
(d) Time and place of oral
presentation. The presiding official will
attempt to schedule the oral
presentation within 45 days of the date
appellant’s request for review is
received or within 15 days of
submission of the last reply brief,
whichever is later. The oral presentation
will be held at a time and place
determined by the presiding official
following consultation with the parties.
(e) Conduct of the oral presentation—
(1) General. The presiding official is
responsible for conducting the oral
presentation. The presiding official may
be assisted by one or more HHS officers
or employees or consultants in
conducting the oral presentation and
reviewing the evidence. While the oral
presentation will be kept as informal as
possible, the presiding official may take
all necessary steps to ensure an orderly
proceeding.
(2) Burden of proof/standard of proof.
In all cases, the respondent bears the
burden of proving by a preponderance
of the evidence that its decision to
suspend, propose revocation, or take
adverse action is appropriate. The
appellant, however, has a responsibility
to respond to the respondent’s
allegations with evidence and argument
to show that the respondent is incorrect.
(3) Admission of evidence. The rules
of evidence do not apply and the
presiding official will generally admit
all testimonial evidence unless it is
clearly irrelevant, immaterial, or unduly
repetitious. Each party may make an
opening and closing statement, may
present witnesses as agreed upon in the
pre-hearing conference or otherwise,
and may question the opposing party’s
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
witnesses. Since the parties have ample
opportunity to prepare the review file,
a party may introduce additional
documentation during the oral
presentation only with the permission
of the presiding official. The presiding
official may question witnesses directly
and take such other steps necessary to
ensure an effective and efficient
consideration of the evidence, including
setting time limitations on direct and
cross-examinations.
(4) Motions. The presiding official
may rule on motions including, for
example, motions to exclude or strike
redundant or immaterial evidence,
motions to dismiss the case for
insufficient evidence, or motions for
summary judgment. Except for those
made during the hearing, all motions
and opposition to motions, including
argument, must be in writing and be no
more than 10 double-spaced pages in
length. The presiding official will set a
reasonable time for the party opposing
the motion to reply.
(5) Transcripts. The presiding official
shall have the oral presentation
transcribed and the transcript shall be
made a part of the record. Either party
may request a copy of the transcript and
the requesting party shall be responsible
for paying for its copy of the transcript.
(f) Obstruction of justice or making of
false statements. Obstruction of justice
or the making of false statements by a
witness or any other person may be the
basis for a criminal prosecution under
18 U.S.C. 1001 or 1505.
(g) Post-hearing procedures. At the
presiding official’s discretion, the
presiding official may require or permit
the parties to submit post-hearing briefs
or proposed findings and conclusions.
Each party may submit comments on
any major prejudicial errors in the
transcript.
§ 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.
PO 00000
Frm 00034
Fmt 4701
Sfmt 4702
(b) Reviewing official’s response. As
soon as practicable after the request for
review is received, the reviewing official
will send an acknowledgment with a
copy to the respondent.
(c) Review file and briefs. Within 10
days of the date the request for review
is received, but no later than 2 days
before an oral presentation, each party
shall submit to the reviewing official the
following:
(1) A review file containing essential
documents relevant to the review,
tabbed, indexed, and organized
chronologically; and
(2) A written statement, not to exceed
20 double-spaced pages, explaining the
party’s position concerning the
suspension and any proposed
revocation. No reply brief is permitted.
(d) Oral presentation. If an oral
presentation is requested by the
appellant or otherwise granted by the
reviewing official in accordance with
§ 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) through (g).
(e) Written decision. The reviewing
official shall issue a written decision
upholding or denying the suspension or
proposed revocation and will attempt to
issue the decision within 7 to 10 days
of the date of the oral presentation or
within 3 days of the date on which the
transcript is received or the date of the
last submission by either party,
whichever is later. All other provisions
set forth in § 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.
§ 8.29
Ex parte communications.
Except for routine administrative and
procedural matters, a party shall not
communicate with the reviewing or
presiding official without notice to the
other party.
§ 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
E:\FR\FM\16DEP3.SGM
16DEP3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
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.
lotter on DSK11XQN23PROD with PROPOSALS3
§ 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.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
(b) Date of decision. The reviewing
official will attempt to issue the
decision within 15 days of the date of
the oral presentation, the date on which
the transcript is received, or the date of
the last submission by either party,
whichever is later. If there is no oral
presentation, the decision will normally
be issued within 15 days of the date of
receipt of the last reply brief. Once
issued, the reviewing official will
immediately communicate the decision
to each party.
(c) Public notice and communications
to the DEA. (1) If the suspension and
proposed revocation of OTP
certification are upheld, the revocation
of certification will become effective
immediately and the public will be
notified by publication of a notice in the
Federal Register. The Secretary will
notify DEA within 5 days that the OTP’s
registration should be revoked.
(2) If the suspension and proposed
revocation of OTP certification are
denied, the revocation will not take
effect and the suspension will be lifted
immediately. Public notice will be given
by publication in the Federal Register.
The Secretary will notify DEA within 5
days that the OTP’s registration should
be restored, if applicable.
77363
303(g)(2)(B) to treat up to 100 patients
was approved;
(b) The practitioner:
(1) Holds additional credentialing as
defined in § 8.2; or
(2) Provides OUD treatment utilizing
covered medications in a qualified
practice setting as defined in § 8.615;
(c) The practitioner has not had his or
her enrollment and billing privileges in
the Medicare program revoked under
§ 424.535 of this title; and
(d) The practitioner has not been
found to have violated the Controlled
Substances Act pursuant to 21 U.S.C.
824(a).
§ 8.615 Definition of a qualified practice
setting.
A qualified practice setting is a
practice setting that:
(a) Provides professional coverage for
patient medical emergencies during
hours when the practitioner’s practice is
closed;
(b) Provides access to casemanagement services for patients
including referral and follow-up
services for programs that provide, or
financially support, the provision of
services such as physical, behavioral,
social, housing, employment,
educational, or other related services;
(c) Uses health information
§ 8.34 Court review of final administrative
technology (health IT) systems such as
action; exhaustion of administrative
electronic health records, if otherwise
remedies.
required to use these systems in the
Before any legal action is filed in
practice setting. Health IT means the
court challenging the suspension,
electronic systems that health care
proposed revocation, or adverse action,
professionals and patients use to store,
respondent shall exhaust administrative share, and analyze health information;
(d) Is registered for their State
remedies provided under this subpart,
prescription drug monitoring program
unless otherwise provided by Federal
(PDMP) where operational and in
law. The reviewing official’s decision,
accordance with Federal and State law.
under § 8.28(e) or § 8.33(a), constitutes
PDMP means a statewide electronic
final agency action as of the date of the
database that collects designated data on
decision.
controlled medications dispensed in the
Subpart E [Reserved]
State. For practitioners providing care in
their capacity as employees or
Subpart F—Authorization To Increase
contractors of a Federal Government
Patient Limit to 275 Patients
agency, participation in a PDMP is
required only when such participation
§ 8.610 Practitioner eligibility requirements
is not restricted based on their State of
for a 3-year 275-patient limit.
licensure and is in accordance with
The total number of patients that a
Federal statutes and regulations; and
practitioner may dispense or prescribe
(e) Accepts third-party payment for
covered medications to at any one time
costs in providing health services,
for purposes of 21 U.S.C.
including written billing, credit, and
823(g)(2)(B)(iii) is 275 if:
collection policies and procedures, or
(a) The practitioner possesses a
Federal health benefits.
current waiver to treat up to 100
§ 8.620 Applying for a 275-patient limit.
patients with OUD under section
303(g)(2) of the Controlled Substances
In order for a practitioner to receive
Act (21 U.S.C. 823(g)(2)) and has
approval for a 3-year patient limit of
maintained the waiver in accordance
275, a practitioner must meet all of the
with applicable statutory requirements
requirements specified in § 8.610 and
without interruption for at least one
submit a Request for Patient Limit
year since the practitioner’s notification Increase to the Secretary that includes
of intent (NOI) under section
all of the following:
PO 00000
Frm 00035
Fmt 4701
Sfmt 4702
E:\FR\FM\16DEP3.SGM
16DEP3
77364
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS3
(a) Completed Request for Patient
Limit Increase form;
(b) Statement certifying that the
practitioner:
(1) Will adhere to nationally
recognized evidence-based guidelines
for the treatment of patients with OUD;
(2) Will provide patients with
necessary behavioral health services as
defined in § 8.2 or through an
established formal agreement with
another entity to provide behavioral
health services;
(3) Will provide appropriate releases
of information, in accordance with
Federal and State laws and regulations,
including the Health Information
Portability and Accountability Act
Privacy Rule (45 CFR part 160 and 45
CFR part 164, subparts A and E) and 42
CFR part 2, if applicable, to permit the
coordination of care with behavioral
health, medical, and other service
practitioners;
(4) Will use patient data to inform the
improvement of outcomes;
(5) Will adhere to a diversion control
plan to manage the covered medications
and reduce the possibility of diversion
of covered medications from prescribed
treatment use;
(6) Has considered how to assure
continuous access to care in the event
of practitioner incapacity or an
emergency-situation that would impact
a patient’s access to care as defined in
§ 8.2; and
(7) Will notify all patients above the
100-patient level, in the event that the
request for the higher patient limit is not
renewed or the renewal request is
denied, that the practitioner will no
longer be able to provide buprenorphine
treatment to them and make every effort
to transfer patients to other treatment
providers; and
(c) Any additional documentation to
demonstrate compliance with § 8.610 as
requested by the Secretary.
medications. A practitioner’s approval
to treat up to 275 patients under this
section will extend for a term not to
exceed 3 years.
(2) The Secretary may deny a
practitioner’s Request for Patient Limit
Increase if the Secretary determines
that:
(i) The Request for Patient Limit
Increase is deficient in any respect; or
(ii) The practitioner has knowingly
submitted false statements or made
misrepresentations of fact in the
practitioner’s Request for Patient Limit
Increase.
(b) If the Secretary denies a
practitioner’s Request for Patient Limit
Increase (or renewal), the Secretary shall
notify the practitioner of the reasons for
the denial.
(c) If the Secretary denies a
practitioner’s Request for Patient Limit
Increase (or renewal) based solely on
deficiencies that can be resolved, and
the deficiencies are resolved to the
satisfaction of the Secretary in a manner
and time period approved by the
Secretary, the practitioner’s Request for
Patient Limit Increase will be approved.
If the deficiencies have not been
resolved to the satisfaction of the
Secretary within the designated time
period, the Request for Patient Limit
Increase may be denied.
§ 8.630 Practitioner requirements to
maintain a 275-patient limit.
A practitioner whose Request for
Patient Limit Increase is approved in
accordance with § 8.625 shall maintain
all eligibility requirements specified in
§ 8.610, and all attestations made in
accordance with § 8.620(b), during the
practitioner’s 3-year approval term.
Failure to do so may result in the
Secretary withdrawing its approval of a
practitioner’s Request for Patient Limit
Increase.
§ 8.625 Processing a 275 Request for
Patient Limit Increase.
§ 8.640 Renewal process for a 3-year 275
Request for Patient Limit Increase.
(a) Not later than 45 days after the
date on which the Secretary receives a
practitioner’s Request for Patient Limit
Increase as described in § 8.620, or
renewal Request for Patient Limit
Increase as described in § 8.640, the
Secretary shall approve or deny the
request.
(1) A practitioner’s Request for Patient
Limit Increase will be approved if the
practitioner satisfies all applicable
requirements under §§ 8.610 and 8.620.
The Secretary will thereafter notify the
practitioner who requested the patient
limit increase, and the DEA, that the
practitioner has been approved to treat
up to 275 patients using covered
(a) Practitioners who intend to
continue to treat up to 275 patients
beyond their current 3-year approval
term must submit a renewal Request for
Patient Limit Increase in accordance
with the procedures outlined under
§ 8.620 no more than 30 days before the
expiration of their current approval
term.
(b) If the Secretary does not reach a
final decision on a renewal Request for
Patient Limit Increase before the
expiration of a practitioner’s approval
term, the practitioner’s existing
approval term will be deemed extended
until the Secretary reaches a final
decision.
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
PO 00000
Frm 00036
Fmt 4701
Sfmt 4702
§ 8.645 Practitioner responsibility when no
renewal request for patient limit increase is
submitted, or whose renewal request is
denied.
Practitioners who are approved to
treat up to 275 patients in accordance
with § 8.625, but who do not renew
their Request for Patient Limit Increase,
or whose renewal request is denied,
shall notify, under § 8.620(b)(7) in a
time period specified by the Secretary,
all patients affected above the 100patient limit, that the practitioner will
no longer be able to provide OUD
treatment services using covered
medications and make every effort to
transfer patients to other treatment
providers.
§ 8.650 Suspension or revocation of the
Secretary’s approval of a practitioner’s
request for patient limit increase.
The Secretary, at any time during a
practitioner’s 3-year approval term, may
suspend or revoke its approval of a
practitioner’s Request for Patient Limit
Increase under § 8.625 if it is
determined that:
(a) Immediate action is necessary to
protect public health or safety;
(b) The practitioner made
misrepresentations in the practitioner’s
Request for Patient Limit Increase;
(c) The practitioner no longer satisfies
the requirements of this subpart; or
(d) The practitioner has been found to
have violated the CSA pursuant to 21
U.S.C. 824(a).
§ 8.655 Temporary increase to treat up to
275 patients in emergency situations.
(a) Practitioners with a current waiver
to prescribe up to 100 patients and who
are not otherwise eligible to treat up to
275 patients under § 8.610 may request
a temporary increase of 6-months to
treat up to 275 patients in order to
address emergency situations as defined
in § 8.2. Practitioners may not be
granted more than 2 consecutive
emergency 275-patient limit requests.
To apply for a 6-month emergency 275patient limit, the practitioner must
provide information and documentation
that:
(1) Describes the emergency situation
in sufficient detail so as to allow a
determination to be made regarding
whether the situation qualifies as an
emergency situation as defined in § 8.2,
and that provides a justification for an
immediate increase in that practitioner’s
patient limit;
(2) Identifies a period of time, not
longer than 6 months, in which the
higher patient limit should apply, and
provides a rationale for the period of
time requested; and
(3) Describes an explicit and feasible
plan to meet the public and individual
E:\FR\FM\16DEP3.SGM
16DEP3
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 / Proposed Rules
lotter on DSK11XQN23PROD with PROPOSALS3
health needs of the impacted persons
once the practitioner’s approval to treat
up to 275 patients expires.
(b) Prior to taking action on a
practitioner’s request under this section,
the Secretary shall consult, to the extent
practicable, with the appropriate
governmental authorities in order to
determine whether the emergency
situation that a practitioner describes
justifies an immediate increase in the
higher patient limit.
(c) If the Secretary determines that a
practitioner’s request under this section
should be granted, the Secretary will
notify the practitioner that his or her
VerDate Sep<11>2014
21:35 Dec 15, 2022
Jkt 259001
request has been approved. The period
of such approval shall not exceed six
months.
(d) If practitioners wish to receive an
extension of the approval period granted
under this section, they must submit a
request to the Secretary at least 30 days
before the expiration of the six-month
period and certify that the emergency
situation as defined in § 8.2
necessitating an increased patient limit
continues. Prior to taking action on a
practitioner’s extension request under
this section, the Secretary shall consult,
to the extent practicable, with the
PO 00000
Frm 00037
Fmt 4701
Sfmt 9990
77365
appropriate governmental authorities in
order to determine whether the
emergency situation that a practitioner
describes justifies an extension of an
increase in the higher patient limit.
(e) Except as provided in this section
and § 8.650, requirements in other
sections under this subpart do not apply
to practitioners receiving waivers in this
section.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2022–27193 Filed 12–13–22; 8:45 am]
BILLING CODE P
E:\FR\FM\16DEP3.SGM
16DEP3
]]>Agencies
[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Proposed Rules]
[Pages 77330-77365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27193]
[[Page 77329]]
Vol. 87
Friday,
No. 241
December 16, 2022
Part IV
Department of Health and Human Services
-----------------------------------------------------------------------
42 CFR Part 8
Medications for the Treatment of Opioid Use Disorder; Proposed Rule
Federal Register / Vol. 87, No. 241 / Friday, December 16, 2022 /
Proposed Rules
[[Page 77330]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
42 CFR Part 8
RIN 0930-AA39
Medications for the Treatment of Opioid Use Disorder
AGENCY: Substance Abuse and Mental Health Services Administration
(SAMHSA), Department of Health and Human Services.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS or ``the
Department'') is issuing this notice of proposed rulemaking (NPRM) to
solicit public comment on its proposal to modify its regulations
regarding medications for the treatment of opioid use disorder.
DATES: Comments due on or before February 14, 2023.
ADDRESSES: Written comments may be submitted through any of the methods
specified below. Please do not submit duplicate comments.
Federal eRulemaking Portal: You may submit electronic
comments at https://www.regulations.gov. Follow the instructions at
https://www.regulations.gov for submitting electronic comments.
Attachments should be in Microsoft Word or Portable Document Format
(PDF), and please refer to RIN 0930-AA39 in all comments.
Regular, Express, or Overnight Mail: You may mail written
comments (one original and two copies) to the following address only:
The Substance Abuse and Mental Health Services Administration, Center
for Substance Abuse Treatment, 5600 Fishers Lane, Room 13-E-30,
Rockville, MD 20857.
Note: Due to the COVID-19 pandemic, SAMHSA notes receipt of mail
may be delayed and encourages submission of comments electronically
to the docket.
Inspection of Public Comments: All comments received by the
accepted methods and due date specified above may be posted without
change to content to https://www.regulations.gov, which may include
personal information provided about the commenter, and such posting may
occur after the closing of the comment period. However, the Department
may redact certain content from comments before posting, including
threatening language, hate speech, profanity, graphic images, or
individually identifiable information about a third-party individual
other than the commenter. Because of the large number of public
comments normally received on Federal Register documents, SAMHSA is not
able to provide individual acknowledgments of receipt. Please allow
sufficient time for mailed comments to be received timely in the event
of delivery or security delays. Comments submitted by fax or email, and
those submitted after the comment period will not be accepted.
FOR FURTHER INFORMATION CONTACT: Robert Baillieu, MD, MPH, Physician
and Senior Advisor, SAMHSA/CSAT, 5600 Fishers Lane, Room 13-E-30,
Rockville, MD 20857, Phone: 202-923-0996, Email:
[email protected].
SUPPLEMENTARY INFORMATION: The discussion below includes an Executive
Summary and overview describing the need for the proposed rule changes,
a section-by-section description of the proposed modifications, and the
impact statement and other required regulatory analyses. The Department
solicits public comment on all aspects of the proposed rule. Persons
interested in commenting on the provisions of the proposed rules can
assist the Department by preceding discussion of any particular
provision or topic with a citation to the section of the proposed rule
being discussed.
Executive Summary
A. Overview
The Controlled Substances Act (CSA), under 21 U.S.C. 823(g)(1),
requires ``practitioners who dispense narcotic drugs to individuals for
maintenance treatment or detoxification treatment'' to ``obtain
annually a separate registration for that purpose'' except as provided
under 21 U.S.C. 823(g)(2). Section 823(g)(1) also provides that,
``[t]he Attorney General shall register an applicant to dispense
narcotic drugs to individuals for maintenance treatment or
detoxification treatment (or both)'' if, among other things, the
applicant ``is determined by the Secretary to be qualified (under
standards established by the Secretary [of HHS]) to engage in the
treatment with respect to which registration is sought[,]'' and ``if
the Secretary determines that the applicant will comply with standards
established by the Secretary (after consultation with the Attorney
General) respecting the quantities of narcotic drugs which may be
provided for unsupervised use by individuals in such treatment.'' 21
U.S.C. 823(g)(1)(A)-(C). The standards authorized under section
823(g)(1) have been published as regulations under part 8 of title 42
of the Code of Federal Regulations (42 CFR part 8 or ``part 8'').\1\
Among other things, these regulations establish the procedures by which
the Secretary of HHS determines whether a program is qualified to
dispense opioid agonist medications in the treatment of opioid use
disorders, and standards regarding the appropriate quantities of opioid
agonist medications that may be provided for unsupervised use by
individuals undergoing such treatment. See 42 CFR 8.1. In addition, ``a
program or practitioner engaged in opioid treatment of individuals with
an opioid agonist treatment medication'' that is also ``registered
under 21 U.S.C. 823(g)(1)'' is described as an ``Opioid Treatment
Program'' (OTP). See 42 CFR 8.2.\2\ The statue, at 21 U.S.C. 823(g)(2),
also authorizes a waiver from the registration requirements of 21
U.S.C. 823(g)(1) for qualifying practitioners seeking to dispense or
prescribe schedule III, IV, or V controlled substances that are Food
and Drug Administration (FDA)-approved for use in ``maintenance and
detoxification treatment.'' Practitioners with a waiver under section
823(g)(2) are limited in the number of patients with opioid use
disorder they may treat at any one time, and depending on the
practitioner's experience or qualifications, this statutory limitation
is set at either 30, 100, or 275. See 21 U.S.C. 823(g)(2)(B)(iii). The
Secretary is also authorized to change the patient limitations by
regulation, and qualifying practitioners must satisfy the requirements
of 42 CFR 8.610 through 8.655 ``(or successor regulations)'' in order
to treat up to 275 patients, which is the maximum number under existing
law. See 21 U.S.C. 823(g)(2)(B)(iii)(II)(dd).\3\
---------------------------------------------------------------------------
\1\ For readability, the Department refers to specific sections
of 42 CFR part 8 using a shortened citation with the ``Sec. ''
symbol except where necessary to distinguish title 42 citations from
other CFR titles, such as title 45 CFR, and in footnotes where the
full reference is used.
\2\ The terms ``narcotic drugs'' and ``detoxification
treatment'' included in this paragraph are found in statute. SAMHSA
recognizes that these terms can be stigmatizing for some people, and
not aligned with current terminology. SAMHSA uses ``opioid agonist
medications'' (see Treatment Improvement Protocol (TIP) 63) as an
alternative to ``narcotic drugs'' and ``withdrawal management'' as
the alternative to ``detoxification treatment''.
\3\ See https://www.govinfo.gov/content/pkg/USCODE-2016-title21/html/USCODE-2016-title21-chap13-subchapI-partC-sec823.htm.
---------------------------------------------------------------------------
In this NPRM, the Department proposes to modify certain provisions
of part 8 to update OTP accreditation and certification standards,
treatment standards for the provision of medications for opioid use
disorder (MOUD) as dispensed by OTPs, and requirements for individual
[[Page 77331]]
practitioners eligible to dispense (including by prescribing) certain
types of MOUD with a waiver under 21 U.S.C. 823(g)(2).
The proposal draws on experience from the COVID-19 Public Health
Emergency (PHE), as well as more than 20 years of practice-based
research. The COVID-19 PHE necessitated changes to policy guidance and
legal exemptions to protect the public's health, promote social
distancing and to preserve patient and staff safety among OTPs. In
March 2020, SAMHSA published flexibilities in the provision of
unsupervised doses of methadone and the use of telehealth in initiating
buprenorphine.\4\ These flexibilities represented the first substantial
change to OTP treatment and medication delivery standards in over 20
years. A growing body of research has demonstrated that these
flexibilities facilitate access to treatment and eliminate criteria
that promote stigma and discourage people from accessing care from
OTPs.
---------------------------------------------------------------------------
\4\ See https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf and https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
---------------------------------------------------------------------------
This proposed rule not only makes these flexibilities permanent,
but also updates standards to reflect an accreditation and treatment
environment that has evolved since part 8 went into effect in 2001.
Accordingly, the Department is proposing to update part 8 to: promote
practitioner autonomy; remove stigmatizing or outdated language; create
a patient-centered perspective; and reduce barriers to receiving care.
These elements have been identified in the literature and in feedback
as being essential to promoting effective treatment in
OTPs.5 6 7
---------------------------------------------------------------------------
\5\ Suen LW, Coe WH, Wyatt JP, Adams ZM, Gandhi M, Batchelor HM,
Castellanos S, Joshi N, Satterwhite S, P[eacute]rez-Rodr[iacute]guez
R, Rodr[iacute]guez-Guerra E, Albizu-Garcia CE, Knight KR, Jordan A.
Structural Adaptations to Methadone Maintenance Treatment and Take-
Home Dosing for Opioid Use Disorder in the Era of COVID-19. Am J
Public Health. 2022 Apr;112(S2):S112-S116. doi: 10.2105/
AJPH.2021.306654. PMID: 35349324; PMCID: PMC8965183.
\6\ Kleinman MB, Felton JW, Johnson A, Magidson JF. ``I have to
be around people that are doing what I'm doing'': The importance of
expanding the peer recovery coach role in treatment of opioid use
disorder in the face of COVID-19 health disparities. J Subst Abuse
Treat. 2021 Mar;122:108182. doi: 10.1016/j.jsat.2020.108182. Epub
2020 Oct 21. PMID: 33160763; PMCID: PMC7577312.
\7\ Suen LW, Castellanos S, Joshi N, Satterwhite S, Knight KR.
``The idea is to help people achieve greater success and liberty'':
A qualitative study of expanded methadone take-home access in opioid
use disorder treatment. Subst Abus. 2022;43(1):1143-1150. doi:
10.1080/08897077.2022.2060438. PMID: 35499469.
---------------------------------------------------------------------------
To this end, the definition of a qualifying practitioner has been
expanded to include a provider who is appropriately licensed by the
state to prescribe (including dispense) covered medications and who
possesses a waiver under 21 U.S.C. 823(g)(2). Admission criteria have
been updated to remove significant barriers to entry, such as the one-
year requirement for opioid use disorder (OUD),\8\ while also defining
the scope and purpose of the `initial' and `periodic' medical
examinations. The proposed rule also includes new definitions to expand
access to evidence-based practices such as split dosing, telehealth and
harm reduction activities. Further to this, outdated terms such as
`detoxification' have been revised to remove stigmatizing language.
---------------------------------------------------------------------------
\8\ See 42 CFR 8.12(e)(1).
---------------------------------------------------------------------------
The Department promotes practitioner autonomy and individualized
care by proposing to revise the provision containing the criteria for
unsupervised doses of methadone. This includes removal of consideration
of the length of time an individual has been in treatment, as well as
rigid reliance on toxicology testing results that demonstrate complete
and sustained abstinence from all substances prone to misuse. Based on
the clinical judgment of the treating provider, patients may be
eligible for unsupervised, take home doses of methadone upon entry into
treatment. This recognizes the importance of the practitioner-patient
relationship, and is consistent with modern treatment standards. It
also allows for greater flexibility in creating plans of care that
promote recovery activities such as employment, while also eliminating
the barrier of frequent visits for individuals without access to
reliable transportation.\9\
---------------------------------------------------------------------------
\9\ Ware OD, Frey JJ, Cloeren M, Mosby A, Imboden R, Bazell AT,
Huffman M, Hochheimer M, Greenblatt AD, Sherman SA. Examining
Employment and Employment Barriers Among a Sample of Patients in
Medication-Assisted Treatment in the United States, Addictive
Disorders & Their Treatment: December 2021--Volume 20--Issue 4--p
578-586 doi: 10.1097/ADT.0000000000000295.
---------------------------------------------------------------------------
Accreditation and certification standards have been reviewed to
codify the use of online/electronic forms, to eliminate types of
certification that are no longer in use, and to update existing types
of certification in a manner that reflects established practice. Part 8
has also been updated to facilitate information sharing between
Accreditation Bodies and SAMHSA, particularly in those circumstances
where there have been changes or violations in accreditation. The
proposed rule also clarifies administrative issues pertaining to mobile
medication units and interim treatment.
The proposed changes seek to make treatment in OTPs more accessible
to patients, easier to deliver for providers and supportive of
evidence-based and patient-centered care. In proposing these changes,
SAMHSA has relied on published evidence, stakeholder feedback and the
need to expand access to care in the face of a growing overdose
epidemic, exacerbated by the COVID-19 PHE.\10\ This is brought further
into focus by the HHS declaration of a public health emergency for the
opioid crisis which has been regularly renewed since 2017.\11\ The
proposed changes are expansive but are focused on permanently
implementing existing flexibilities and updating practices. In this
way, SAMHSA believes that much of what is proposed in the rule will not
represent a significant burden for OTPs and, in fact, will offer many
benefits to providers and patients. The proposed rule, therefore,
supports OTPs in their on-going provision of equitable and evidence-
based care to often marginalized patients with OUD. The proposed rule
also is consistent with the HHS Overdose Prevention Strategy which
calls for increasing access to and the uptake of evidence-based
treatments for substance use disorders.\12\
---------------------------------------------------------------------------
\10\ Tanz LJ, Dinwiddie AT, Snodgrass S, O'Donnell J, Mattson
CL, Davis NL. A qualitative assessment of circumstances surrounding
drug overdose deaths during the early stages of the COVID-19
pandemic. SUDORS Data Brief, No 2. Atlanta, GA: Centers for Disease
Control and Prevention, U.S. Department of Health and Human
Services; 2022.
\11\ See https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
\12\ See https://www.hhs.gov/overdose-prevention/.
---------------------------------------------------------------------------
B. Effective and Compliance Dates
The proposed effective date of a final rule would be 60 days after
publication of the final rule and the compliance date would be 6 months
after the effective date. Entities subject to the final rule would have
until the compliance date to achieve compliance with this rule.
C. Summary of Major Proposals
The Department proposes the following changes to 42 CFR part 8 that
revise, delete, replace, or add sections. This section summarizes major
proposals in this NPRM. Additional proposed revisions are not listed
here because they are not considered major.\13\ All proposed changes
are discussed in detail in section III of this NPRM:
---------------------------------------------------------------------------
\13\ Generally, the proposals not listed make wording changes,
not substantive changes. These proposals are reviewable in the
regulatory text.
---------------------------------------------------------------------------
[[Page 77332]]
1. Heading.
The heading of part 8 has been changed from Medication Assisted
Treatment for Opioid Use Disorders to Medications for the Treatment of
Opioid Use Disorder to reflect currently accepted medical terminology
and to remove language that is widely viewed to be stigmatizing.
2. Subpart A.
Subpart A currently addresses accreditation and includes steps that
accreditation bodies must follow to obtain approval to accredit OTPs.
It also sets forth accreditation bodies' responsibilities, including
the use of accreditation elements, during accreditation surveys. In the
proposed rule, these specifications are relocated to subpart B, which
still would include Certification of Opioid Treatment Programs. The
proposed rule limits subpart A to the preamble and definitions.
3. Section 8.1--Scope.
Revised Sec. 8.1 to reflect modern medical terminology, to detail
updated acronyms, and for clarity. Of note, the term medication
assisted treatment (MAT) has been updated to MOUD, and the term
treatment program has been changed to opioid treatment program
throughout the proposed rule.
4. Section 8.2--Definitions.
Revised Sec. 8.2 to add and update definitions. Added definitions
include: care plan; harm reduction; individualized dose; long-term care
facility; recovery support services; split dosing; and telehealth.
Existing definitions updated include: comprehensive treatment;
medication for opioid use disorder; and practitioner. The term
detoxification treatment is removed and replaced with withdrawal
management.
5. Section 8.3--Application For Approval as an Accreditation Body.
Added details of policies and procedures expected of accreditation
bodies, particularly that accreditation bodies shall include staff
physician(s) with experience in treating OUD with MOUD in their survey
team. A correction has been made to the email address to which the
accreditation application is submitted. The current rule calls for the
accreditation bodies' training policies to be provided as part of their
application process. Furthermore, this regulation would be updated to
ensure that accreditation bodies provide training policies specifically
related to training of survey team members. In addition to state or
territorial governments, the proposed rule also provides for Indian
Tribes to apply for approval as an accreditation body.
6. Section 8.4--Accreditation Body Responsibilities.
Amended to clarify expectations for cooperation of accreditation
bodies with SAMHSA's oversight. These include steps to be taken by
accreditation bodies in response to OTPs that are found to not be
complying with accreditation or certification standards, such as follow
up on corrective measures and confirmation of timely corrections. Time
frames are also established for submission of survey reports. The
proposed rule adds a requirement that all records of accreditation
activities be made available to SAMHSA upon request. Current
requirements regarding accreditation body follow up on complaints are
maintained, but the proposed rule adds a requirement that accreditation
bodies notify SAMHSA of all aspects of a complaint response within 5
days of receipt. The current rule requiring surveyors to recuse
themselves from surveys due to conflict of interest is amended to
clarify that such conflicts must be documented by the accreditation
body and made available to SAMHSA.
7. Section 8.11--Opioid Treatment Program Certification.
This section is amended to update categories of certification, to
clarify SAMHSA's expectation that OTPs maintain certification, and to
establish procedures for OTPs whose certification has lapsed. Current
terms for the extension of certification are amended to clarify the
circumstances in which an extension could be requested, and the means
of requesting an extension are defined in the proposed rule. The
proposed rule also updates the certification application process to
reflect the shift from paper applications to electronic submission, and
the email address for submission of supporting documents is corrected.
The proposed rule removes ``transitional certification'' which
expired as a category of certification in 2003. The wording of
``provisional certification'' is amended to clarify that it is a
category of certification available only to new programs that have not
been previously certified, and a new category of ``conditional
certification'' has been added for OTPs that have received a one-year
conditional accreditation status from an accrediting body--an
organization that has been approved by the Secretary of HHS to accredit
OTPs--in order for operations to continue or resume as the OTP takes
steps needed to achieve permanent certification. The criteria for
granting certification extensions outside of routine certification
renewals has been expanded to address extensions needed under
extraordinary circumstances. The grammar used in describing procedures
for requesting an extension was revised.
The applicability of Health Insurance Portability and
Accountability Act (HIPAA) privacy protections have been explained,
along with clarification that changes in the status of the program
sponsor or medical director must be submitted to SAMHSA in writing. The
chapter of the Controlled Substances Act with which OTPs are expected
to comply has been added; the chapter number is not included in the
current version of the rule.
The conditions for approval of interim treatment have been amended
to increase the duration of interim treatment from 120 days to 180
days, with the stipulation that individuals shall not be discharged
without the approval of an OTP practitioner while awaiting transfer to
a comprehensive treatment program. A reference to section 1923 of the
Public Health Service Act (21 U.S.C. 300x-23) is removed. The proposed
rule also shifts the need to seek approval from the `chief public
health officer' of the state in which the OTP operates to the State
Opioid Treatment Authority in the state in which the OTP operates.
The services that can be provided in medication units have been
clarified to explicitly allow the full range of OTP services, based on
space and privacy available in the medication unit.
8. Section 8.12--Federal Opioid Use Disorder Treatment Standards.
Revisions of treatment standards incorporated in this section aim
to improve access to treatment, improve patient satisfaction and
engagement in services and support use of clinical judgment in
decision-making. In several instances, stigmatizing language such as
``legitimate treatment use'' of controlled substances, has been removed
and patient-centered language is added.
The paragraph on staff credentials is amended to expand the
definition of ``qualifying practitioners'' to a ``physician, physician
assistant, nurse practitioner, clinical nurse specialist, certified
registered nurse anesthetist, or certified nurse midwife who is
appropriately licensed by a State to prescribe covered medications and
who possesses a waiver under 21 U.S.C. 823(g)(2).'' The expectation
that all licensed and credentialed staff maintain
[[Page 77333]]
licensure and/or certification has been added.
Criteria for admission to treatment removes reference to the
Diagnostic and Statistical Manual of Mental Disorders (DSM) IV and
eliminates the requirement for a one-year history of OUD. The proposed
rule instead specifies that the individual should either: meet
diagnostic criteria for active moderate to severe OUD; that the
individual may be in OUD remission; or at high risk for recurrence or
overdose. The section is amended to assure that the basis for the
admission decision is documented in the patient's record. In
recognition of the use of telehealth and its limitation in obtaining
physical signatures, the requirement to obtain written patient consent
to treatment is removed. Consent may be provided verbally or
electronically, and documented as such. The requirement that
individuals under age 18 have two documented unsuccessful attempts at
short term withdrawal management (``detoxification'') or drug free
treatment is also amended to allow consent of a parent, legal guardian,
or responsible adult. Further to this, the rule requiring a 1-year
history of OUD for people recently released from penal institutions,
pregnant patients or previously enrolled individuals has been removed.
Throughout the document, ``detoxification'' and the corresponding
definition and standards for short-and long-term detoxification
treatment have been removed. ``Withdrawal management'' and terms for
tapering from MOUD are added on behalf of individuals who seek this
approach or who elect or need to reduce and/or discontinue MOUD.
The ``Required services'' paragraph is revised to incorporate
patient-centered language, establish flexible terminology, promote use
of clinical judgment, and clarify SAMHSA's expectations of OTPs. The
proposed rule creates the requirement that services be available that
meet patient needs, and ``shared decision making'' is added as the
method to be used in developing care plans.
The paragraph describing the initial medical examination has been
amended to clarify the terms ``screening'' medical exam and
``comprehensive examination'', while also expanding the qualifications
of practitioners able to complete such examinations. These include
practitioners outside of the OTP (with limitations and specific
instructions). The proposed rule also creates criteria for lab testing
conducted prior to a screening medical exam, as well as a permissible
timeframe. The use of telehealth in undertaking the screening medical
exam and initiation of MOUD has also been addressed in the proposed
rule. Additionally, the paragraph on special services for pregnant
people is amended to specify that confirmation of pregnancy is required
for priority treatment admissions. The option to use split dosing for
patients is also added.
The components of initial and periodic medical examinations have
been expanded in the proposed rule to incorporate assessment of
behavioral health, risk of self-harm or harm to others, and to specify
time frames for completion of the care plan. Areas of psychosocial
assessment are amended so as to assure information is gathered on the
context of the patient's whole life such as their mental health,
housing, recovery support and harm reduction resources. Additionally,
patient-centered language has been added, such as ``services a patient
needs and wishes to pursue''.
The proposed rule expands the definition of `counseling services'
to include psychoeducational services, harm reduction and recovery-
oriented services, and counseling and linkage to treatment for anyone
with positive test results on human immunodeficiency virus (HIV), viral
hepatitis, and other sexually transmitted infection (STI) panels, or
from OTP-provided medical examinations. Language about services that
must be provided directly or through referral is revised to promote a
patient-centered approach to care that does not make medication
continuity contingent upon involvement in counseling services but
fosters shared decision-making for all care plans.
The requirement that an OTP have a formal documented agreement with
outside agencies is amended to remove the word ``formal''; the proposed
rule calls for a ``documented agreement'' to provide such services.
Language that addresses drug testing services has been amended to
remove stigmatizing phrases, such as ``drug abuse'', and to remove
content on short-term withdrawal management (``detoxification'').
Further to this, the requirement to use drug tests that have received
the FDA's marketing authorization was added.
Rules that address recordkeeping and efforts to avoid simultaneous
enrollment in multiple OTPs are amended to be more declarative, such as
changing the word ``review'' to ``determine'' whether or not a patient
is enrolled in another OTP, and documenting review efforts in the
patient's record to demonstrate the good faith efforts made. The
proposed rule also expands the circumstances in which a patient may
obtain treatment at another OTP to include instances when there is an
inability to access care at the OTP of record.
Specification of disciplines authorized to administer or dispense
MOUD is removed from the rule. LAAM, also known as Levacetylmethadol,
is removed from the list of treatment medications because it is no
longer available, and other medications approved since prior revisions
to this rule were added. The regulation of an initial dose of methadone
remains at 30mg, not to exceed 40mg on the first day, with the
incorporation of a provision for higher doses if clinically indicated
and documented in the patient's record. The rule to ensure
documentation of any significant deviation from FDA-approved labeling
has been maintained in the proposed rule, while redundant language was
removed.
Rules on the provision of unsupervised (or take home) doses of
methadone are substantially amended to incorporate flexibilities issued
in response to the COVID-19 pandemic. Stigmatizing language is removed,
and the criteria for decision-making is reframed to promote use of
clinical judgement and patient-centered care. In general, the revised
criteria allow up to 7 days of take home doses during the first 14 days
of treatment, up to 14 take home doses from 15 days of treatment and up
to 28 take home doses from 31 days in treatment. The requirement that
OTPs maintain procedures to protect take homes from theft and diversion
was continued, and patient education on safe transport and storage of
take home doses is added, including documentation of the provision of
this education in the patient's clinical record.
Consistent with the conditions for approval of interim treatment,
the proposed rule extends the potential duration of interim treatment
from 120 days to 180 days. It also clarifies the circumstances in which
interim treatment may apply and maintains priority access to
comprehensive services for pregnant individuals. The proposed rule
removes the requirement for observation of all daily doses during
interim treatment. It clarifies the expectation that crisis services
and information pertaining to locally available, community-based
resources for ancillary services be made available to individual
patients in interim treatment. A requirement of a plan for continuing
treatment beyond 180 days of interim services was added to the proposed
rule.
[[Page 77334]]
9. Section 8.13--Revocation of Accreditation and Accreditation Body
Approval.
Changes in this section were limited to referring to an OTP as a
``program'' instead of a ``facility''.
10. Section 8.14--Suspension or Revocation of Certification.
This section refines steps SAMHSA may take when immediate action is
necessary to protect public health or safety.
11. Subpart D--Procedures for Review of Suspension or Proposed
Revocation of OTP Certification, and of Adverse Action Regarding
Withdrawal of Approval of an Accreditation Body.
Language referencing ``treatment program'' in this section was
changed to ``OTP'' for document consistency.
12. Subpart F--Authorization To Increase Patient Limit to 275 Patients.
This subpart has been amended to change the format from the prior
Question-and-Answer style to a standard format.
13. Section 8.610--Practitioner Eligibility Requirements for a 3-Year
275-Patient Limit.
Modernized language to refer to MOUD and to remove stigmatizing
language that referred to `legitimate medications'. The proposed rule
also clarified that the 275-patient waiver is limited to three years in
duration, requiring renewal.
14. Section 8.635--What are the reporting requirements for
practitioners whose 275 request for patient limit is approved?
The proposed rule removes reporting requirements for practitioners
approved to treat up to 275 patients, eliminating Sec. 8.635 in its
entirety.
Background and Need for Proposed Rule
As of June 2022 there are over 1,920 OTPs in the United States,
providing care to over 650,000 patients. These are the only settings
within which methadone, a schedule II opioid receptor agonist, can be
legally provided to people with OUD outside the context of hospital
admission or certain other special circumstances.\14\
---------------------------------------------------------------------------
\14\ See 21 CFR 1306.07.
---------------------------------------------------------------------------
An OTP is an accredited treatment program with SAMHSA certification
and Drug Enforcement Administration (DEA) registration to administer
and dispense opioid agonist medications that are approved by FDA to
treat OUD. Currently, these include methadone and buprenorphine, a
schedule III partial opioid receptor agonist. Other pharmacotherapies,
such as naltrexone, may be provided but are not subject to regulations
under part 8. For purposes of certification, OTPs must also provide
adequate medical, counseling, vocational, educational, and other
assessment and treatment services either onsite or by referral to an
outside agency or practitioner.\15\ Buprenorphine can also be dispensed
(including by prescribing) to treat OUD by eligible practitioners with
a waiver under 21 U.S.C. 823(g)(2) in settings outside of OTPs given
its different scheduling and treatment under the Controlled Substances
Act.\16\
---------------------------------------------------------------------------
\15\ Substance Abuse and Mental Health Services Administration.
(2015). Federal guidelines for opioid treatment programs. HHS
Publication No. (SMA) PEP15-FEDGUIDEOTP. Rockville, MD: Substance
Abuse and Mental Health Services Administration.
\16\ 21 U.S.C. 823(g)(2); Substance Abuse and Mental Health
Services Administration. Medications for Opioid Use Disorder.
Treatment Improvement Protocol (TIP) Series 63 Publication No.
PEP21-02-01-002. Rockville, MD: Substance Abuse and Mental Health
Services Administration, 2021.
---------------------------------------------------------------------------
Practitioners treating OUD and the OTPs in which they practice must
continuously adapt to evolving patterns of drug misuse. Over the past
40 years, this has been complicated by rapid changes in prescribing
practices, supply chains and patterns of drug use. Indeed, the early
opioid epidemic of the 1990s was characterized by an increased supply
of prescription opioids.\17\ By 2010, however, the U.S. began to see
rapid increases in overdose deaths involving heroin \18\ and then by
2013, synthetic opioids other than methadone--primarily illicitly
manufactured fentanyl--contributed to a further rise in overdose-
related deaths.19 20
---------------------------------------------------------------------------
\17\ Centers for Disease Control and Prevention (CDC). Vital
signs: overdoses of prescription opioid pain relievers--United
States, 1999-2008. MMWR MorbMortal Wkly Rep. 2011 Nov 4;
60(43):1487-1492.
\18\ Rudd RA, Paulozzi LJ, Bauer MJ, Burleson RW, Carlson RE,
Dao D, Davis JW, Dudek J, Eichler BA, Fernandes JC, Fondario A.
Increases in heroin overdose deaths--28 states, 2010 to 2012.MMWR
MorbMortal Wkly Rep. 2014 Oct 3; 63(39):849.
\19\ Gladden RM, Martinez P, Seth P. Fentanyl law enforcement
submissions and increases in synthetic opioid-involved overdose
deaths--27 states, 2013-2014. MMWR MorbMortal Wkly Rep. 2016;
65:837-43.
\20\ O'Donnell JK, Gladden RM, Seth P. Trends in deaths
involving heroin and synthetic opioids excluding methadone, and law
enforcement drug product reports, by census region--United States,
2006-2015. MMWR MorbMortal Wkly Rep. 2017; 66:897-903.
---------------------------------------------------------------------------
The isolation, anxiety and reduced access to resources experienced
by many during the COVID-19 pandemic has exacerbated substance misuse
and overdose deaths. According to provisional data from the Centers for
Disease Control and Prevention (CDC), a predicted 107,375 Americans
died from a drug overdose in the 12-month period ending in January
2022.\21\ Synthetic opioids (primarily illicitly manufactured fentanyl)
appear to be the principal driver of overdose deaths, increasing 55
percent from 2019 to 2020 and further increasing 26 percent from 2020
to 2021.\22\ Overdose deaths involving cocaine also increased by 22
percent from 2019 to 2020. These deaths are likely linked to co-use or
mixing (by illicit producers) of cocaine with illicitly manufactured
fentanyl or heroin.\23\ The rise in fentanyl use or exposure,
concurrent substance misuse, as well as overdose deaths, necessitates
changes to part 8 that expand access to care, and promote engagement in
OTP services, while also maintaining oversight and accreditation
activities. Oversight and accreditation standards are supported as a
means of promoting evidence-based care, while minimizing diversion and
also adverse patient outcomes.
---------------------------------------------------------------------------
\21\ Ahmad, F.B., Rossen, L.M., Sutton, P. (2021). Provisional
drug overdose death counts. National Center for Health Statistics.
\22\ Wide-ranging online data for epidemiologic research
(WONDER). Atlanta, GA: CDC, National Center for Health Statistics;
2022. Available at https://wonder.cdc.gov.
\23\ Ibid.
---------------------------------------------------------------------------
A. Regulatory Background
On January 17, 2001 (66 FR 4075), the Department issued final
regulations for the use of opioid agonist medications (referred to as
narcotic drugs) in treatment and withdrawal management (referred to as
detoxification) of OUD. The final rule repealed the treatment
regulations enforced by the FDA, and created a new regulatory system
based on an accreditation model. In addition, the final rule shifted
administrative responsibility and oversight from the FDA to SAMHSA.
This rulemaking initiative followed a study by the Institute of
Medicine (IOM) (now known as the National Academy of Medicine) and
reflected recommendations by the IOM and several other entities to
improve the treatment of OUD by allowing for increased medical judgment
in the care of patients with OUD. Since publication of the final rule
in 2001, it has been updated to include new medications, such as
buprenorphine, while also updating or adding new rules governing the
provision of such medications.
Between 1972 and 2001, Federal regulatory oversight of OTPs was
[[Page 77335]]
enforced by the FDA before responsibility for oversight was transferred
to SAMHSA. Periodic reviews, studies, and reports on the Federal
oversight system culminated with the 1995 IOM Report entitled Federal
Regulation of Methadone Treatment.\24\ The IOM report recommended that
the FDA process-oriented regulations should be reduced in scope to
allow more clinical judgment in treatment and greater reliance on
guidelines. The IOM report also recommended designing a single
inspection format, having multiple elements, that would (1) provide for
consolidated, comprehensive inspections conducted by one agency (under
a delegation of Federal authority, if necessary), which serves all
agencies (Federal, State, local) and (2) improve the efficiency of the
provision of methadone services by reducing the number of inspections
and consolidating their purposes.
---------------------------------------------------------------------------
\24\ For full text, see: https://www.ncbi.nlm.nih.gov/books/NBK232108/.
---------------------------------------------------------------------------
To address these recommendations, SAMHSA proposed a
``certification'' system based on accreditation. Under the system, an
applicant who intended to dispense opioid agonist medications in the
treatment of OUD must first obtain from SAMHSA, a certification that
the applicant is qualified under the Secretary's standards and will
comply with such standards. Eligibility for certification depended upon
the applicant obtaining accreditation from a private nonprofit entity,
or from a State agency, that had been approved by SAMHSA to accredit
OTPs.
Accreditation bodies were directed to base accreditation decisions
on a review of an application for accreditation and on surveys (onsite
inspections) conducted every three years by OUD treatment experts. In
addition, accreditation bodies must apply specific opioid treatment
accreditation elements that reflect ``state-of-the-art'' opioid
treatment guidelines. Further to this, accreditation standards required
that OTPs have quality assurance systems that consider patient
outcomes.
The 2001 final regulations replaced FDA `approval' of programs,
with direct government inspection in accordance with more detailed
process-oriented regulations. These process-oriented regulations
continue to prescribe many aspects of oversight and treatment. To this
end, subpart B of the regulation addresses accreditation and includes
steps that accreditation bodies must follow to achieve approval to
accredit OTPs. It also sets forth the accreditation bodies'
responsibilities, including the use of accreditation elements during
accreditation surveys. Subpart C describes the sequence and
requirements for obtaining certification, and addresses how and when
programs must apply for initial certification and renewal of their
certification. Subpart D elucidates the procedures for review of the
withdrawal of approval of the accreditation body or the suspension and
proposed revocation of an OTP certification. Subpart F, added in 2016,
describes criteria for increasing the patient limit for those meeting
Federal requirements to prescribe buprenorphine to 275.\25\
---------------------------------------------------------------------------
\25\ See https://www.federalregister.gov/documents/2016/07/08/2016-16120/medication-assisted-treatment-for-opioid-use-disorders.
---------------------------------------------------------------------------
In 2001 there were close to 900 OTPs, but that number has grown to
over 1900 by 2022.\26\ Over this period of time, the incidence of
fentanyl misuse has increased, escalating with the onset of the COVID-
19 public health emergency in early 2020. To protect the public's
health and reduce the risk of COVID-19 infection among patients and
providers, SAMHSA issued flexibilities in the provision of unsupervised
doses of methadone and also initiation of buprenorphine via telehealth,
that allowed for continued treatment of OUD with reduced direct patient
contact. Each of these flexibilities represented a significant change
to treatment standards, and are discussed in detail below.
---------------------------------------------------------------------------
\26\ SAMHSA treatment locator. See https://dpt2.samhsa.gov/treatment/directory.aspx.
---------------------------------------------------------------------------
Flexibility for Methadone Medication Take Homes in Opioid Treatment
Programs
Among the existing standards for medication administration and
dispensing of methadone are limitations on unsupervised or ``take
home'' use. These prior standards were established early in the history
of methadone as a medication for OUD, and the criteria for determining
whether a patient may be allowed take homes were restrictive, requiring
daily visits to the OTP for extended periods of time, and adherence to
strict measures of sustained stability as described in 42 CFR part
8.\27\ These criteria can pose disruption to employment and daily
activities for patients, and several of the criteria reflect outdated
biases that promote stigma and discourage people from engaging in care
in OTPs.
---------------------------------------------------------------------------
\27\ https://www.ecfr.gov/current/title-42/chapter-I/subchapter-A/part-8?toc=1.
---------------------------------------------------------------------------
In March 2020, as a result of the pandemic, SAMHSA issued
exemptions that allowed state regulatory authorities to request blanket
exceptions to allow patients to take home more doses of methadone; 43
states and the District of Columbia did so.\28\ With this flexibility,
SAMHSA allowed OTPs to dispense 28 days of ``take home'' methadone
doses to ``stable'' patients for the treatment of OUD, and up to 14
doses of ``take home'' methadone for ``less stable'' patients ``who the
OTP believes can safely handle this level of take home medication.''
\29\ Although the duration of this flexibility was not initially
specified, a SAMHSA FAQ published in April 2020, indicated that the
flexibility was tied with the duration of ``the current national health
emergency . . . .'' \30\
---------------------------------------------------------------------------
\28\ HHS Guidance for Opioid Treatment Programs. https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf.
\29\ See https://www.samhsa.gov/sites/default/files/otp-guidance-20200316.pdf.
\30\ See https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
---------------------------------------------------------------------------
The intention of the methadone take home flexibility was to reduce
the risk of COVID-19 infection among patients and providers. Beyond
this, the flexibility promotes individualized care that considers
patient characteristics and program involvement beyond time in
treatment. By reducing the burden on patients to visit the OTP daily,
this flexibility could reduce stigma for those seeking treatment, while
also providing more equitable access to care as telemedicine in OTPs is
expanded. It also allows those who reside far from an OTP or who lack
access to reliable transportation to receive treatment, while also
being able to gain or maintain employment, care for loved ones and
engage in other required activities of daily living.
The methadone take home flexibility has been met with widespread
support among patients,\31\ OTPs,\32\ and state authorities.\33\
Patients reported that increased take home doses of methadone left them
feeling more respected as responsible individuals.\31\ In a recent
meeting, state authorities reported that the flexibilities were
appreciated by patients and OTPs alike,
[[Page 77336]]
with no significant change in rates of diversion seen since the COVID-
19 PHE was declared. Indeed, analysis of the relevant data indicates
that the actual level of misuse, diversion or harm from methadone is
more likely to occur when it is prescribed for pain as opposed to OUD,
and that the rate of diversion is lower than that of oxycodone or
hydrocodone.\34\ Additionally, a recent survey found that diversion of
methadone is low among patients receiving take home doses under the
COVID-19 PHE flexibility.35 36 Further to this, analysis of
data on fatal overdoses from January 2019 to August 2021 demonstrated
that this flexibility did not lead to more deaths involving
methadone.\37\
---------------------------------------------------------------------------
\31\ Hatch-Maillette MA, Peavy KM, Tsui JI, Banta-Green CJ,
Woolworth S, Grekin P. Re-thinking patient stability for methadone
in opioid treatment programs during a global pandemic: Provider
perspectives. J Subst Abuse Treat. 2021 May;124:108223. doi:
10.1016/j.jsat.2020.108223. Epub 2020 Dec 5. PMID: 33342667; PMCID:
PMC8005420.
\32\ Joseph G, Torres-Lockhart K, Stein MR, Mund PA, Nahvi S.
Reimagining patient-centered care in opioid treatment programs:
Lessons from the Bronx during COVID-19. J Subst Abuse Treat. 2021
Mar;122:108219. doi: 10.1016/j.jsat.2020.108219. Epub 2020 Dec 3.
PMID: 33353790; PMCID: PMC7833302.
\33\ ``To Save Lives From Opioid Overdose Deaths, Bring
Methadone Into Mainstream Medicine'', Health Affairs Forefront, May
27, 2022.
\34\ National Institute on Drug Abuse (NIDA). 2018, June.
Medications to Treat Opioid Use Disorder. Retrieved from https://irp.drugabuse.gov/wp-content/uploads/2019/12/NIDA-Medications-to-treat-opioid-use-disorder_2018.pdf.
\35\ Figgatt, MC, Salazar Z, Day E, Vincent L, Dasgupta N. Take-
home dosing experiences among persons receiving methadone
maintenance treatment during COVID-19, Journal of Substance Abuse
Treatment, Volume 123, 2021, https://doi.org/10.1016/j.jsat.2021.108276.
\36\ Dooling, B.C.E. & Stanley, L.E. (2021). Unsupervised use of
opioid treatment medications: Report II of the extending pandemic
flexibilities for opioid use disorder treatment project. GW
Regulatory Studies Center. https://regulatorystudies.columbian.gwu.edu/unsupervised-use-opioid-treatment-medications.
\37\ Jones, C. M., Compton, W. M., Han, B., Baldwin, G., &
Volkow, N. D. (2022). Methadone-Involved Overdose Deaths in the US
Before and After Federal Policy Changes Expanding Take-Home
Methadone Doses From Opioid Treatment Programs. JAMA psychiatry,
e221776. Advance online publication. https://doi.org/10.1001/jamapsychiatry.2022.1776.
---------------------------------------------------------------------------
Recognizing the importance of this flexibility, SAMHSA released
guidance on November 18, 2021, that extended the methadone take home
flexibility for one year past the end of COVID PHE. This was to
accommodate the rule making process that proposes to make this
flexibility permanent. In this proposed rule, SAMHSA has reviewed and
updated criteria used to determine eligibility for take home doses of
methadone, while also promoting shared decision making that is
supported by availability of unsupervised doses of methadone from entry
into treatment. Individuals receiving take home doses of methadone are
supported through individually tailored telehealth visits to
practitioners, counselors and other services as indicated. Further to
this, the proposed changes highlight practitioner autonomy in
determining eligibility for unsupervised doses of methadone. This is a
significant change to treatment standards, but it is grounded in
evidence that demonstrates the safety and efficacy of promoting patient
and provider autonomy.
The Opioid Treatment Program Flexibility To Prescribe MOUD via
Telehealth Without an Initial In-Person Physical Evaluation
Telehealth is a mode of service delivery that has been used in
clinical settings for over 60 years and empirically studied for just
over 20 years. 38 39 40 Between 2016 and 2019, use of
telehealth, in general, doubled from 14 to 28 percent,\41\ while
substance use disorder (SUD) treatment, offered through telehealth over
the same period, increased from 13.5 to 17.4 percent.\42\ This trend
has rapidly increased between 2019 and 2021, due to the COVID-19
pandemic.\43\
---------------------------------------------------------------------------
\38\ Bashshur, R.L., Shannon, G.W., Bashshur, N., & Yellowlees,
P.M. (2016). The empirical evidence for telemedicine interventions
in mental disorders. Telemedicine and e-Health, 22(2), 87-113.
\39\ Lustig, T. (2012). The role of telehealth in an evolving
health care environment: Workshop summary. National Academies Press.
\40\ Mace, S., Boccanelli, A., & Dormond, M. (2018). The use of
telehealth within behavioral health settings: Utilization,
opportunities, and challenges. University of Michigan School of
Public Health, Behavioral Health Workforce Research Center.
\41\ American Medical Association (2019). Telehealth
implementation playbook. Digital Health Implementation Playbook
Series. https://www.ama-assn.org/system/files/2020-04/ama-telehealthimplementation-playbook.pdf.
\42\ Uscher-Pines, L., Cantor, J., Huskamp, H.A., Mehrotra, A.,
Busch, A., & Barnett, M. (2020). Adoption of telemedicine services
by substance abuse treatment facilities in the U.S. Journal of
Substance Abuse Treatment, 117, 108060.
\43\ Melamed OC, deRuiter WK, Buckley L, Selby P. Coronavirus
Disease 2019 and the Impact on Substance Use Disorder Treatments.
Psychiatr Clin North Am. 2022 Mar;45(1):95-107. doi: 10.1016/
j.psc.2021.11.006. Epub 2021 Nov 12. PMID: 35219445; PMCID:
PMC8585604.
---------------------------------------------------------------------------
The pandemic spurred use of telemedicine for the treatment of OUD
using buprenorphine, a schedule III partial opioid receptor agonist.
Prior to buprenorphine's development, the only opioid agonist that
could be used to treat OUD was methadone dispensed through OTPs.
Methadone has a relatively complicated pharmacological profile,
necessitating closer observation of new patients to ensure that initial
doses do not exceed an individual's tolerance for the medication. The
Drug Addiction Treatment Act of 2000 (DATA 2000) allowed practitioners
to treat OUD outside of OTPs using buprenorphine, generally with an
initial in-person medical evaluation before prescribing.
On March 16, 2020, the Secretary of HHS, with the concurrence of
the Acting DEA Administrator, designated that the telemedicine
exception under 21 U.S.C. 802(54)(D), applied to all schedule II-V
controlled substances.\44\ Accordingly, DEA-registered, DATA-Waived
practitioners may issue buprenorphine prescriptions through
telemedicine to new patients for whom they have not conducted an in-
person medical evaluation, provided certain conditions are met during
the COVID-19 public health emergency.
---------------------------------------------------------------------------
\44\ See https://www.deadiversion.usdoj.gov/coronavirus.html.
---------------------------------------------------------------------------
On March 25, 2020, the DEA also granted a ``temporary exception''
to its regulations that allows practitioners to prescribe controlled
medications in states in which they are not registered, if the
practitioner is registered with the DEA in at least one state and is
authorized by both the state where the practitioner is registered with
DEA and the state where the dispensing occurs.\45\ According to the
DEA, practitioners may utilize this temporary exception via in-person
prescribing or prescribing via telemedicine. The DEA also specified
that this exception is granted through ``the duration of the COVID-19
public health emergency as declared by the Secretary of Health and
Human Services.'' \46\
---------------------------------------------------------------------------
\45\ See Exception to Separate Registration Requirements Across
State Lines (DEA067), https://www.deadiversion.usdoj.gov/GDP/(DEA-
DC-018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf.
\46\ With respect to methadone delivery, during the COVID-19
public health emergency, the DEA has also authorized employees of
OTPs to personally deliver methadone to patients who otherwise
cannot travel to the OTP, and has issued a waiver to permit law
enforcement and National Guard personnel to deliver methadone
directly to patients of OTPs. See https://www.deadiversion.usdoj.gov/faq/coronavirus_faq.htm#NTP_FAQ.
---------------------------------------------------------------------------
Building upon this, SAMHSA implemented OTP regulatory flexibilities
designed to help address the impact of the COVID-19 pandemic on OTPs
and their patients.\47\ In April 2020, SAMHSA exempted OTPs from the
requirement to perform an in-person physical evaluation (under 42 CFR
8.12(f)(2)) for any patient who will be treated by the OTP with
buprenorphine if a program physician, primary care physician, or an
authorized healthcare professional under the supervision of a program
physician, determines that an adequate evaluation of the patient can be
accomplished via telehealth. The duration of this exemption was
specifically tied with the ``period of the national emergency declared
in response to the COVID-19 pandemic'',\48\ and the exemption did not
include
[[Page 77337]]
induction of methadone via telehealth technology.
---------------------------------------------------------------------------
\47\ OTPs are authorized to dispense narcotic maintenance and
detoxification medication under 21 U.S.C. 823(g)(1) and regulated
under 42 CFR part 8.
\48\ See https://www.samhsa.gov/sites/default/files/faqs-for-oud-prescribing-and-dispensing.pdf.
---------------------------------------------------------------------------
Recent research has demonstrated that telehealth can be an
effective tool in integrating care and extending the reach of specialty
providers,\49\ and that among those requiring treatment with
buprenorphine, there are high levels of satisfaction with the use of
telehealth services.\50\ Additionally, there are no significant
differences between telehealth and in-person buprenorphine induction in
the rate of continued substance use, retention in treatment or
engagement in services.38 51 Research also shows that there
is no significant difference in client and provider ratings of
therapeutic alliance when using telehealth technology platforms.\39\
---------------------------------------------------------------------------
\49\ Guille, C., Simpson, A.N., Douglas, E., Boyars, L.,
Cristaldi, K., McElligott, J., Johnson, D., & Brady, K. (2020).
Treatment of opioid use disorder in pregnant women via telemedicine:
A nonrandomized controlled trial. JAMA Network Open, 3(1), e1920177-
e1920177.
\50\ King, V.L., Brooner, R. K., Peirce, J.M., Kolodner, K., &
Kidorf, M.S. (2014). A randomized trial of web-based
videoconferencing for substance abuse counseling. Journal of
Substance Abuse Treatment, 46(1), 36-42.
\51\ Vakkalanka, J.P., Lund, B. C., Ward, M.M., Arndt, S.,
Field, R.W., Charlton, M., & Carnahan, R.M. (2022). Telehealth
Utilization Is Associated with Lower Risk of Discontinuation of
Buprenorphine: a Retrospective Cohort Study of US Veterans. Journal
of general internal medicine, 37(7), 1610-1618. https://doi.org/10.1007/s11606-021-06969-1.
---------------------------------------------------------------------------
In the face of an escalating overdose crisis and an increasing need
to reach remote and underserved communities, making the buprenorphine
telehealth flexibility permanent is of paramount importance. The
proposed rule makes permanent criteria of initiation of buprenorphine
via audio-only or audio-visual telehealth technology if an OTP
physician, primary care physician, or an authorized healthcare
professional under the supervision of a program physician, determines
that an adequate evaluation of the patient can be accomplished via
telehealth.
SAMHSA believes that evidence underlying the initiation of
buprenorphine using telehealth translates, to some degree, to the
treatment of OUD with methadone, and warrants expanding access to
methadone therapy by applying some of the buprenorphine in-person
examination flexibilities to treatment with methadone in OTPs.\52\ The
proposed rule allows for the use of audio-visual telehealth for any new
patient who will be treated by the OTP with methadone if a program
physician, or an authorized healthcare professional under the
supervision of a program physician, determines that an adequate
evaluation of the patient can be accomplished via an audio-visual
telehealth platform. SAMHSA is not extending this change to the use of
audio-only telehealth platforms in assessing new patients who will be
treated with methadone because methadone, in comparison to
buprenorphine, holds a higher risk profile for sedation in patients
presenting with mild somnolence which may be easier to identify through
an audio-visual telehealth platform. The proposed rule is not
applicable to, and does not authorize, the prescription of methadone
pursuant to a telehealth visit. Instead, this proposed change applies
to the ordering of methadone by appropriately licensed OTP
practitioners and dispensed to the individual patient by the OTP under
existing OTP procedures.
---------------------------------------------------------------------------
\52\ Chan B, Bougatsos C, Priest KC, McCarty D, Grusing S, Chou
R. Opioid treatment programs, telemedicine and COVID-19: A scoping
review. Subst Abus. 2022;43(1):539-546. doi: 10.1080/
08897077.2021.1967836. Epub 2021 Sep 14. PMID: 34520702.
---------------------------------------------------------------------------
Further to this, health care providers who receive Federal
financial assistance are reminded of their obligations to ensure that
their audio-only and audio-visual telehealth platforms are accessible
to individuals with disabilities and afford an opportunity for
meaningful access for limited English proficient (LEP) individuals.
Federal civil rights laws prohibit discrimination on the basis of
disability and may require health care providers to make reasonable
modifications to their policies, practices, or procedures to ensure
that a person who is not able to use an audio-visual telehealth
platforms on the basis of their disability has an equal opportunity to
benefit from treatment with MOUD. Similarly, Federal civil rights laws
that prohibit discrimination on the basis of national origin (including
language ability), require recipients to take reasonable steps to
provide meaningful access to LEP individuals, which may require the
provision of a qualified interpreter and/or translated material, such
that they have the opportunity benefit from treatment with MOUD.
Expanding Access to Services
On June 28, 2021, the DEA introduced requirements for OTPs to add a
``mobile component'' to their existing registration and waived any
obligation for an OTP mobile medication unit complying with these
requirements to separately register at the remote locations where it
dispenses.\53\ On September 21, 2021, SAMHSA released guidance on the
establishment of mobile and non-mobile medication units and allowable
services.\54\ While part 8 currently allows OTPs certified by SAMHSA to
establish medication units (as defined under 42 CFR 8.2), the proposed
rule further defines mobile units and clarifies potential services,
interventions and accreditation processes.
---------------------------------------------------------------------------
\53\ See 86 FR 33861; https://www.federalregister.gov/documents/2021/06/28/2021-13519/registration-requirements-for-narcotic-treatment-programs-with-mobile-components.
\54\ See https://www.samhsa.gov/medication-assisted-treatment/statutes-regulations-guidelines#mobile.
---------------------------------------------------------------------------
Additionally, the proposed rule defines harm reduction and promotes
expansion of harm reduction services to OTP patients.\55\ The
importance of this has been highlighted during the COVID-19 pandemic,
principally with the CDC and SAMHSA's April 7, 2021, joint announcement
that Federal funding could be used to purchase rapid fentanyl test
strips (FTS).\56\ This was proposed in an effort to help curb the
dramatic spike in drug overdose deaths largely driven by the use (both
intentional and unintentional) of potent synthetic opioids, primarily
illicitly manufactured fentanyl. FTS can be used to determine if drugs
have been mixed or cut with fentanyl, providing people who use drugs
and their communities with important information about fentanyl in the
illicit drug supply so they can take steps to reduce their risk of
overdose. Other important harm reduction activities highlighted in the
proposed rule include: counseling on preventing exposure to, and the
transmission of, HIV, viral hepatitis, and STIs; providing access to
services and treatments for those with HIV, viral hepatitis or an STI;
provision of patient-centered harm reduction education; and
distribution of opioid overdose reversal medications (e.g.,
naloxone).\57\
---------------------------------------------------------------------------
\55\ The proposed rule does not permit OTPs to engage in any
activities that would violate Federal, State, or local law.
\56\ See https://www.cdc.gov/media/releases/2021/p0407-Fentanyl-Test-Strips.html.
\57\ See https://www.samhsa.gov/blog/new-samhsa-guide-highlights-hiv-prevention-treatment-people-substance-use-andor-mental.
---------------------------------------------------------------------------
The need to facilitate access to services has been highlighted
during the COVID-19 pandemic. This is particularly important in the
face of increased exposure to fentanyl. Section 8.12(e)(1) of the
proposed rule eliminates the requirement that a person must have had an
addiction to opioids for one year before admission to treatment and
receipt of OTP services, and permits access to those: who meet
diagnostic criteria for a moderate to severe OUD; individuals with
active
[[Page 77338]]
moderate to severe OUD, or OUD in remission; or those individuals who
are at high risk for overdose or recurrence of use. Admission to the
OTP is contingent upon appropriate informed consent and education, as
well as appropriate documentation of consent in the patient's clinical
record.
These activities are supported, in the proposed rule, through
defining a practitioner (in Sec. 8.2) as being ``a physician,
physician assistant, nurse practitioner, clinical nurse specialist,
certified registered nurse anesthetist, or certified nurse midwife who
is appropriately licensed by a State to prescribe covered medications
and who possesses a waiver under 21 U.S.C. 823(g)(2).'' Further to
this, the proposed rule expands decision making capacity of OTP
practitioners to: admission of patients; the provision of treatment
activities; and service provision. This is supported by the use of
telehealth, described above, and involvement of outside practitioners.
Indeed, Sec. 8.12(f)(2) of the proposed rule allows for the initial
medical examination to be completed by a practitioner external to the
OTP no more than seven days prior to admission, provided that it is
verified by an OTP practitioner. This expands access to OTP services
and is consistent with current medical practice.
In this way, the proposed rule draws on evidence from the COVID-19
pandemic as well as over 20 years of practice-based research. The
proposed rule makes permanent or expands upon flexibilities initiated
during the COVID-19 PHE and recognizes the efficacy and safety of
creating a less restrictive and patient-centered treatment environment.
Further to this, the evidence demonstrates the positive impact of not
requiring frequent patient visits to the OTP. This has been shown to
promote recovery behaviors, such as sustained employment, as well as
support those individuals who live a long distance from the OTP.\58\
The integration of telehealth into the proposed rule further supports
this and allows OTPs flexibility in initiating MOUD.
---------------------------------------------------------------------------
\58\ Treitler, P.C., Bowden, C.F., Lloyd, J., Enich, M., Nyaku,
A.N., & Crystal, S. (2022). Perspectives of opioid use disorder
treatment providers during COVID-19: Adapting to flexibilities and
sustaining reforms. Journal of substance abuse treatment, 132,
108514. https://doi.org/10.1016/j.jsat.2021.108514.
---------------------------------------------------------------------------
Section-by-Section Description of Proposed Amendments to 42 CFR Part 8
Below, the Department describes the proposals in this NPRM to amend
42 CFR part 8. The Department believes that the proposed rule expands
access to evidence-based and patient-centered care, limits use of
stigmatizing language, and promotes the practitioner-patient
relationship. These changes are in line with evidence-based practice,
and the Department welcomes feedback on all aspects of the proposed
rule.
In particular, the Department is interested in feedback on the
proposal to increase the allowable time for interim treatment from 120
days to 180 days. This is intended to accommodate OTPs and states as
they address important issues such as staff shortages. It may also
serve as a way of engaging individuals in care. Such issues underlie
the need for this service approach, and while SAMHSA is working with
other Federal and State agencies to build workforce capacity, the use
of interim treatment adds to the care continuum for people with OUD.
The Department also seeks feedback on other paradigms of care
promoted in the proposed rule. Split-dosing and delivery of services
via telehealth are, for example, evidence-based interventions that
promote patient-centered care. The Department proposes to expand access
to evidence-based treatment through the addition of such practices, and
seeks guidance on the proposed use of these interventions and their
integration into the practice environment.
Also proposed are new criteria to support decision making around
take home doses of methadone. The take home flexibility issued at the
start of the COVID-19 pandemic demonstrated that length of time in
treatment, as well as strict negative toxicology test results were not
central to positive outcomes.\58\ This is reflected in the proposed
rule, and feedback is solicited on the proposed criteria, as well as
the schedule for providing unsupervised doses of methadone.
The Department further requests comment on all proposals described
in the following paragraphs of this NPRM. In addition, the Department
requests comment on all aspects of the Regulatory Impact Analysis,
including the assumptions and estimates about the costs and benefits of
the proposed changes, and the alternatives the Department considered
when developing the proposals in this NPRM.
The Department proposes the following amendments to part 8:
A. Heading
The Department proposes to revise the heading to Medications for
the Treatment of Opioid Use Disorder to reflect current medical
terminology and to remove stigmatizing language. The term `opioid use
disorder' more precisely reflects the diagnosis for which medications
are indicated. Further to this, the terms `maintenance' and
`detoxification' reference outdated terminology that has potentially
hindered adoption of evidence-based treatments for OUD.\59\ The amended
heading reflects current medical terminology and highlights that OUD is
a chronic, treatable condition.
---------------------------------------------------------------------------
\59\ NIDA. 2021, November 29. Words Matter--Terms to Use and
Avoid When Talking About Addiction. Retrieved from https://nida.nih.gov/nidamed-medical-health-professionals/health-professions-education/words-matter-terms-to-use-avoid-when-talking-about-addiction.
---------------------------------------------------------------------------
B. Subpart A
Subpart A currently addresses accreditation and includes steps that
accreditation bodies will follow to achieve approval to accredit OTPs
under the new rules. It also sets forth the accreditation bodies'
responsibilities, including the use of accreditation elements during
accreditation surveys. In the proposed rule, these specifications are
relocated to subpart B, which still includes Certification of Opioid
Treatment Programs. In this way, subpart A is now limited to the
overview of part 8 and definitions. This improves categorization and
provides clear flow within the proposed rule.
C. Section 8.1--Scope
This section has been revised to reflect modern medical terminology
and to detail updated acronyms. Historically, pharmacological treatment
for opioid use disorder was referred to as ``medication assisted
treatment'' (MAT). There is an increasing movement towards the more
medically accurate term ``medication for opioid use disorder'' (MOUD)
since this precisely describes the medications that are being provided,
carries less stigma, and aligns with treatment approaches to all other
health conditions. Further to this, the term `MAT' implies that these
medications are simply adjuncts to a broader treatment strategy.\60\ In
fact, these medications are one critical element of a comprehensive,
long-term treatment and recovery strategy.\60\ As such, the acronym MAT
has been removed from the proposed rule and replaced with MOUD
throughout. The proposed rule identifies other treatment modalities,
such as counseling, by their individual component names, similar to
[[Page 77339]]
the manner by which elements of other chronic disease care are
described.
---------------------------------------------------------------------------
\60\ Substance Abuse and Mental Health Services Administration.
Medications for Opioid Use Disorder. Treatment Improvement Protocol
(TIP) Series 63 Publication No. PEP21-02-01-002. Rockville, MD:
Substance Abuse and Mental Health Services Administration, 2021.
---------------------------------------------------------------------------
D. Section 8.2--Definitions
In the 21 years since part 8 was first published, definitions and
paradigms of care for OUD have changed. In particular, treatment for
OUD has evolved from being prescriptive to multimodal and patient-
centered.\61\ This reflects an understanding that OUD is a chronic
condition \62\ and that to be successful, treatment interventions
should be individualized and include harm reduction and recovery
support services. Further to this, flexibilities expanded under the
COVID-19 PHE demonstrated the safety of telehealth interventions.\63\
Accordingly, telehealth is defined in this section using a standard
definition. The proposed rule updates other definitions to reflect
current evidence and practice in the provision of care in OTPs. This is
seen in an expanded definition of `practitioner'. Patients have
benefitted for years from the care provided by nurse practitioners
(NPs) and physician assistants (PAs) in OTPs, and the proposed rule
expands the definition of practitioner to include a ``physician,
physician assistant, nurse practitioner, clinical nurse specialist,
certified registered nurse anesthetist, or certified nurse midwife.''
Finally, the proposed rule removes the term ``detoxification
treatment'' and replaces it with ``withdrawal management.'' The term
detoxification is customarily called medically supervised withdrawal
management to destigmatize the process and more accurately reflect what
patients undergo, and healthcare practitioners provide, in response to
withdrawal from a variety of substances or medications to which
physiologic tolerance develops.\64\
---------------------------------------------------------------------------
\61\ Mark TL, Hinde J, Henretty K, Padwa H, Treiman K. How
Patient Centered Are Addiction Treatment Intake Processes? J Addict
Med. 2021 Apr 1;15(2):134-142. doi: 10.1097/ADM.0000000000000714.
PMID: 32826618.
\62\ Russell HA, Sanders M, Meyer JKV, Loomis E, Mullaney T,
Fiscella K. Increasing Access to Medications for Opioid Use Disorder
in Primary Care: Removing the Training Requirement May Not Be
Enough. J Am Board Fam Med. 2021 Nov-Dec;34(6):1212-1215. doi:
10.3122/jabfm.2021.06.210209. PMID: 34772776.
\63\ Langabeer JR 2nd, Yatsco A, Champagne-Langabeer T.
Telehealth sustains patient engagement in OUD treatment during
COVID-19. J Subst Abuse Treat. 2021 Mar;122:108215. doi: 10.1016/
j.jsat.2020.108215. Epub 2020 Nov 24. PMID: 33248863; PMCID:
PMC7685137.
\64\ Substance Abuse and Mental Health Services Administration.
Medications for Opioid Use Disorder. Treatment Improvement Protocol
(TIP) Series 63 Publication No. PEP21-02-01-002. Rockville, MD:
Substance Abuse and Mental Health Services Administration, 2021.
---------------------------------------------------------------------------
E. Section 8.3--Application for Approval as an Accreditation Body
This section adds details of policies and procedures expected of
accreditation bodies for clarity and completeness. In Sec. 8.3(b) the
email address for submission of accreditation body applications is
updated. Changes to Sec. 8.3(b)(6) reflect the expectation that
physicians with experience in managing MOUD are employed by
accreditation bodies to assure appropriate medical standards of care
are established and included in review of OTPs. Further amendments are
incorporated to promote communication between the accreditation bodies
and SAMHSA, and to ensure that accreditation bodies focus on OTP
adherence to 42 CFR part 8. Expectations about training provided for
survey team members are added to promote consistency in OTP reviews
with Federal standards and to reduce the risk of unnecessary and overly
burdensome accreditation activities. Further to this, the proposed rule
also provides for Indian Tribes to apply for approval as an
accreditation body.
F. Section 8.4--Accreditation Body Responsibilities
SAMHSA is responsible for oversight of the accreditation bodies. A
thorough review of its oversight procedures resulted in several
proposed changes to improve processes, to assure documentation of
accreditation decisions, and to establish steps to be taken to assure
OTP adherence to 42 CFR part 8. For example, making records available
to SAMHSA on request is added to assure that SAMHSA can review survey
processes and information, and confirm decisions of survey outcomes.
Other amendments, such as accreditation body policies for training
survey team members, have been added to address concerns regarding
inconsistent application of accreditation standards and regulations.
The documentation and sharing of information regarding conflict or
perceived conflict of interest has been added to ensure any conflict of
interest and action taken by the accreditation body is disclosed to
SAMHSA.
G. Section 8.11--Opioid Treatment Program Certification
The requirements for certification and renewal have been in place
since 2001. Therefore, it is necessary to update these as some
certifications and processes no longer apply. For example,
``transitional certification'' expired as a category in May 2003. Other
revisions have been incorporated based on SAMHSA's 20-years of
experience in OTP certification.
The category of ``provisional'' certification required
clarification as to when provisional certification is available.
Moreover, the current rule only designates three-year certifications
for OTPs, whether the accreditation survey resulted in a ``full'' (3-
year) or ``conditional'' 1-year accreditation status. The proposed rule
establishes the category of ``conditional certification'' to allow an
OTP granted a temporary one-year accreditation to continue treatment
services while the OTP takes steps to address issues identified during
the accreditation process. The current regulation limits extension of
certification status to OTPs with provisional certification only.
Circumstances related to the COVID-19 PHE necessitated expansion of
extensions for renewal of any category of certification.
The expectation that OTPs comply with HIPAA regulations when
applicable is added to emphasize rules that govern practice that have
come into effect since 2001. Documentation of change of sponsors or
medical directors is added to assure written records are available, and
a reference to the applicable chapter of the Controlled Substances Act
for OTPs was added to clarify the DEA regulations to which OTPs must
adhere.
Interim treatment means that on a temporary basis, a patient may
receive services from an OTP, while awaiting access to more
comprehensive treatment services. The extension of interim treatment
approval from 120 days to 180 days is intended to better accommodate
OTPs and states in addressing underlying causes necessitating this
category of treatment, such as staff shortages. This approach may also
serve to engage individuals with OUD who otherwise may not seek care.
Given the significant mortality risk of illicit fentanyl and data
demonstrating reductions in overdose death with methadone treatment,
interim services add an opportunity for low-threshold access to life-
saving services. The expectation that individuals enrolled in interim
treatment shall not be discharged without the approval of an OTP
practitioner is to assure continuity of and engagement in care for the
individual as an interim step to a comprehensive treatment program
where additional services are available. The reference to section 1923
of the Public Health Service Act (PHSA) (42 U.S.C. 300x-23) is removed
because it does not specifically pertain to time in interim treatment.
The proposed rule also changes the need to seek approval
[[Page 77340]]
from the `chief public health officer of the state in which the OTP
operates' to the State Opioid Treatment Authority (SOTA) of the state
in which the OTP operates. This change was made to streamline and
centralize the application process.
An overall goal of these revisions is to expand access to MOUD,
specifically to OTP services. Accordingly, the range of services that
can be provided in medication units has been clarified to improve
access to the services OTPs offer, especially in geographic areas in
which distances are a key barrier to accessing treatment.
H. Section 8.12--Federal Opioid Use Disorder Treatment Standards
OTP regulations currently do not reflect the changes in OUD
treatment standards that have occurred over the past 20 years. The dual
challenges of the COVID-19 pandemic and the evolving opioid overdose
epidemic necessitated review and revision of these regulations.
Significant lessons have been learned from adapting treatment in
response to the need for physical distancing and quarantine, and from
the results of implementing flexibilities for take home doses and use
of telehealth under the COVID-19 PHE.
Overcoming the opioid crisis through the expansion of prevention,
treatment, and recovery support services is a primary priority for
SAMHSA, and SAMHSA seeks to expand access to quality treatment
services, encourage the use of MOUD, and improve engagement and
retention in treatment and recovery support services. Consistent with
that goal, amendments to treatment standards incorporated in this
section are intended to improve access to care and improve patient
satisfaction and engagement in services, while also promoting
flexibility and medical judgment in decision-making to reduce the
burden of patient participation in OTPs.
Changes to the ``Required services'' paragraph incorporate patient-
centered language, and promote flexibility in the use of clinical
judgment. For example, required services are amended to assure that
OTPs meet patient needs, and ``shared decision making'' is added to
ensure that the patient be included in the development and
implementation of their care plan. In several instances, the intent of
standards was not changed, but stigmatizing wording such as
``legitimate treatment use'' of controlled substances has been removed.
These amendments are incorporated as a means of reducing the use of
stigmatizing attitudes, practices and language within OTPs that may
contribute to discrimination and impede access to treatment.\65\
---------------------------------------------------------------------------
\65\ See https://www.justice.gov/opa/pr/justice-department-issues-guidance-protections-people-opioid-use-disorder-under-americans.
---------------------------------------------------------------------------
Other revisions in this section are included to ensure alignment
with laws and regulations that have been issued since 2001 and to
emphasize their importance to OTPs. These include HIPAA, the
Comprehensive Addiction and Recovery Act (CARA), and the Substance Use-
Disorder Prevention that Promotes Opioid Recovery and Treatment for
Patients and Communities (SUPPORT) Act. Section 303 of CARA, for
example, expanded the definition of ``qualifying practitioners'' from
physicians to include nurse practitioners and physician assistants who
meet certain criteria; this change has been included in the section on
staff credentials and is in alignment with the professionalization of
SUD treatment services that has occurred over the last 20
years. 66 67
---------------------------------------------------------------------------
\66\ Center for Substance Abuse Treatment. Competencies for
Substance Abuse Treatment Clinical Supervisors. Technical Assistance
Publication (TAP) Series 21-A. HHS Publication No. (SMA) 12-4243.
Rockville, MD: Substance Abuse and Mental Health Services
Administration, 2007/2013.
\67\ Center for Substance Abuse Treatment. Clinical Supervision
and Professional Development of the Substance Abuse Counselor.
Treatment Improvement Protocol (TIP) Series 52. HHS Publication No.
(SMA) 144435. Rockville, MD: Substance Abuse and Mental Health
Services Administration, 2009/2014.
---------------------------------------------------------------------------
A significant change in OTP access is the removal of the
requirement that patients must have had an addiction to opioids for at
least one year prior to admission for MOUD; this is a vestige of prior
versions of the DSM and has posed a barrier to access to treatment. OUD
includes signs and symptoms that are associated with compulsive,
prolonged use of opioid substances for non-medical purposes, despite
harm and negative consequences to the individual with OUD. Therefore,
the assessment of OUD is refocused, in the proposed rule, to
consideration of problematic patterns of opioid use that are in line
with the current version of the DSM diagnostic categories.\68\ The
proposed rules also recognize the potential for recurrence of OUD in
individuals who have sustained remission and recovery and the high
mortality risk associated with these situations. The revised definition
allows for clinical judgment and consideration of severity of use and
comorbid conditions. The new rules also remove the requirement that
individuals under 18 must have two documented unsuccessful attempts at
treatment within one year to be eligible for MOUD. Except where not
required by state law, parental consent to treatment remains a
requirement for patients under age 18. In recognition of the use of
telehealth and the limitation of obtaining written consent, the
requirement for a written form of consent to treatment was removed for
adult patients.
---------------------------------------------------------------------------
\68\ See https://www.aoaam.org/resources/Documents/Clinical%20Tools/DSM-V%20Criteria%20for%20opioid%20use%20disorder%20.pdf.
---------------------------------------------------------------------------
Throughout the document, ``detoxification'' and the corresponding
definition and standards for short- and long-term detoxification have
been removed as the word ``detoxification'' is considered a pejorative
term and not accurately reflective of the process of managing or
experiencing the withdrawal associated with substances or medications
to which physiologic tolerance develops. Detoxification is an outdated
term that was used to distinguish opioid dependence from OUD based on
the Narcotic Addiction Treatment Act of 1974 (NATA). Practice-based
evidence and extensive research shows that treatment with MOUD is more
effective than withdrawal management at reducing OUD recurrence and
associated mortality and morbidity risk.\69\ However, it is recognized
that some patients may choose, or need, to taper off MOUD. Therefore,
``withdrawal management'' and terms for tapering from MOUD are included
in the section of the regulations that currently refer to
``detoxification.''
---------------------------------------------------------------------------
\69\ Kleber HD. Pharmacologic treatments for opioid dependence:
detoxification and maintenance options. Dialogues Clin Neurosci.
2007;9(4):455-70. doi: 10.31887/DCNS.2007.9.2/hkleber. PMID:
18286804; PMCID: PMC3202507.
---------------------------------------------------------------------------
Language used in the current rule about the initial medical
examination required clarification to distinguish between an initial
``screening'' exam and a more comprehensive ``examination.'' For
patients with OUD, initiating MOUD is of utmost importance to suppress
withdrawal, engage the individual in additional services, and improve
retention. The need to improve access to treatment necessitates
expanding the qualifications of those practitioners able to complete
screening examinations. The proposed rule allows practitioners who work
outside of the OTP (with limitations and specific instructions) to
undertake screening. This is likely to reduce delays in diagnosing OUD,
initiating MOUD, and in beginning comprehensive treatment. This section
also improves medical services by setting expectations for lab testing,
establishing time frames for examinations, and incorporating use of
[[Page 77341]]
telehealth. Special services for pregnant people have been revised to
specify that confirmation of pregnancy is required for priority
treatment admissions to prevent misuse of priority status. The option
to use split dosing for patients was added to this section, as well.
Changes to the initial and periodic medical services sections are
intended to promote key issues for OTP medical practitioners and the
OTP multi-disciplinary team to address with a patient as part of
treatment. This includes areas that may increase the risk of a patient
leaving care prematurely, such as unmet mental health or other
disability, medical and oral health needs, the need for culturally
supportive care that addresses race, ethnicity, sexual orientation,
religion or gender identity, and social determinants of health, such as
housing and transportation, that may pose barriers to treatment
engagement, or harm reduction and recovery support service needs.
Patient-centered language was added to ensure that the care provided is
consistent with the patient's needs, and self-identified goals for
treatment and recovery. The time frames for completion of the care plan
are included as a measure of quality. Also included is the requirement
in Sec. 8.12(f)(4)(i) that individuals starting treatment be screened
for imminent risk of harm to self or others. This recognizes that risk
for suicide is increased among individuals who misuse substances \70\
and that appropriate screening, intervention, and referrals for care
are vital to health and engagement in treatment activities.\71\
---------------------------------------------------------------------------
\70\ Substance Abuse and Mental Health Services Administration
(2015). Substance Use and Suicide: A Nexus Requiring a Public Health
Approach. In Brief.
\71\ Lynch Fl., Peterson EL, Lu CY, Hu Y, Rossom RC, Waitzfelder
BE, Owen-Smith AA, Hubley S, Parbhakar D, Keoki Williams L, Beck A,
Simon GE, Ahmedani BK. Substance use disorders and risk of suicide
in a general US population: a case control study. Addict Sci Clin
Pract. 2020 Feb 21;15(1):14. doi:10.1186/s13722-020-0181-1. PMID:
32085800; PMCID: PMC7035727.
---------------------------------------------------------------------------
Counseling services have been more finely described to align OTP
services with the current paradigm for evidence-based SUD treatment.
This includes the delineation of psychoeducational services, overdose
prevention and other harm reduction counseling, and recovery-oriented
counseling services. Specific counseling on reducing HIV, hepatitis C,
and other STIs, and linkage to treatment for anyone with positive test
results from OTP-provided laboratory testing, was added to improve
quality of care. Language about services that must be provided directly
or through referral has also been revised to infuse a more patient-
centered approach, such as in ``identified and mutually agreed-upon as
beneficial by the patient and program staff,'' rather than the program
staff determining that the patient is ``in need of such services.''
Drug testing services have been revised to remove the stigmatizing
language of ``drug abuse,'' to remove content on short-term withdrawal
management (``detoxification''), and to improve readability. The
requirement for use of drug tests that have received FDA's marketing
authorization was added to assure valid assays are used.
The current regulations require OTPs to review whether a patient is
enrolled in another OTP prior to admission. Simultaneous enrollment in
multiple OTPs risks patients obtaining more medication than is needed.
Good faith efforts to prevent this must be documented. Therefore, the
language regarding verification of non-enrollment changed from
``review'' to ``determine'' in order to ensure that evidence of good
faith efforts is available. This section also expands the circumstances
in which a patient may obtain treatment at another OTP to include
instances when there is an inability to access care at the OTP of
record. Experiences of state and OTP responses to occurrence of natural
disasters gave evidence of the need to incorporate this allowance on
behalf of patients.
In Sec. 8.12(h) (Medication administration, dispensing, and use),
the specific disciplines authorized to administer or dispense MOUD have
been removed to accommodate variations among states regarding
disciplines allowed to provide this service. Among medications used by
OTPs, LAAM has been removed as it has black box warnings and is no
longer commercially available, while other medications approved since
2001 (naltrexone) were added. Although the maximum initial dose of
methadone remains at 30 mg, use of clinical judgment in dose
adjustments is underscored, due to higher opioid tolerance associated
with increasing rates of fentanyl exposure and opioid overdose. Should
30 mg be insufficient to control symptoms of withdrawal, the program
physician or practitioner may increase the dosage, provided that the
rationale for this change is appropriately documented. The requirement
that the program physician be familiar with the most up-to-date product
labeling has been removed as Sec. 8.12(d) requires that each person
engaged in the treatment of OUD must have sufficient education,
training, and experience, or any combination thereof, to enable that
person to perform the assigned functions. This is inclusive of the
expectation that all program medical practitioners maintain familiarity
with the most up-to-date product labeling for the medications they
administer and dispense to patients.
The exemption policies promulgated by SAMHSA in response to COVID-
19 allowed OTPs to provide more take home doses of methadone to
patients on a more rapid schedule than is permitted in the current
regulations. In the two years since implementation, there have been few
reports of overdose or harm related to take homes, misuse, or other
negative consequences of this flexibility. Evidence from multiple
studies has shown that increases in take home doses following the
SAMHSA exemption did not lead to worse treatment outcomes, higher
overdose rates, or diversion of medication, but instead resulted in
increased treatment engagement and improved patient satisfaction with
care.72 73 74 75 There are sufficient studies to conclude
that this exemption has enhanced and encouraged use of and retention in
OTP services; therefore, the proposed rule for unsupervised (take home)
doses fully incorporates the flexibilities for take home medication
issued during the COVID-19 PHE.
---------------------------------------------------------------------------
\72\ Figgatt, M.C., Salazar, Z., Day, E., Vincent, L., &
Dasgupta, N. (2021). Take-home dosing experiences among persons
receiving methadone maintenance treatment during COVID-19. Journal
of substance abuse treatment, 123, 108276. https://doi.org/10.1016/j.jsat.2021.108276.
\73\ Joseph, G., Torres-Lockhart, K., Stein, M.R., Mund, P.A., &
Nahvi, S. (2021). Reimagining patient-centered care in opioid
treatment programs: Lessons from the Bronx during COVID-19. Journal
of substance abuse treatment, 122, 108219. https://doi.org/10.1016/j.jsat.2020.108219.
\74\ Amram, O., Amiri, S., Panwala, V., Lutz, R., Joudrey, P.J.,
& Socias, E. (2021). The impact of relaxation of methadone take-home
protocols on treatment outcomes in the COVID-19 era. The American
journal of drug and alcohol abuse, 47(6), 722-729. https://doi.org/10.1080/00952990.2021.1979991.
\75\ Brothers S., Viera A., Heimer R. Changes in methadone
program practices and fatal methadone overdose rates in Connecticut
during COVID-19 Journal of Substance Abuse Treatment. 2021
Dec;131:108449. doi: 10.1016/j.jsat.2021.108449. Epub 2021 Apr 29.
PMID: 34098303.
---------------------------------------------------------------------------
The proposed rule removes stigmatizing language in favor of person-
centered approaches and person-first terminology. Changes focus on the
well-being of the individual and reframe the criteria for unsupervised
medication from rule-based to clinical judgment-based decisions. When
determining take home medication schedules under the proposed rule,
SAMHSA recommends that the best interest of each patient and the
public's health be taken into consideration, and that clinical
judgement, not rigid rules, determine if the therapeutic benefit of
take home
[[Page 77342]]
medication outweighs the risks to the patient and public health. The
proposed rule is meant to address barriers to care associated with the
requirement for regular clinic attendance while also improving patient
satisfaction and treatment engagement in a manner that also balances
patient and public health safety.
The conditions for interim treatment extend the potential duration
of this approach from 120 days to 180 days. This is based on SAMHSA's
experience and reports from states that the underlying issues which
prompted interim treatment, such as staff shortages, are not easily
resolved in 120 days.76 77 In addition, interim services may
serve as a low-threshold approach to engaging individuals with OUD in
care, particularly in areas where OTPs offering more comprehensive
services are not as readily available. Clarification of language in
this section also ensures that patients in interim treatment have
documented plans for continuation of treatment beyond 180 days, and are
not discharged based on length of time in interim care. The
circumstances in which a patient could receive interim services
required clarification from ``cannot be placed in a public or nonprofit
private program'' to ``if comprehensive services are not readily
available.'' Services to be provided in this category are revised to
assure alignment of quality expectations for interim care between OTPs
and SAMHSA.
---------------------------------------------------------------------------
\76\ Sigmon SC. Interim treatment: Bridging delays to opioid
treatment access. Prev Med. 2015;80:32-36. doi:10.1016/
j.ypmed.2015.04.017.
\77\ Oleskowicz TN, Ochalek TA, Peck KR, Badger GJ, Sigmon SC.
Within-subject evaluation of interim buprenorphine treatment during
waitlist delays. Drug Alcohol Depend. 2021 Mar 1;220:108532. doi:
10.1016/j.drugalcdep.2021.108532. Epub 2021 Jan 20. PMID: 33508690;
PMCID: PMC8148627.
---------------------------------------------------------------------------
On July 28, 2021, the DEA published a final rule that permits DEA
registrants who are authorized to dispense methadone for OUD to add a
``mobile component'' to their existing registration--waiving any
requirement that mobile medication units of OTPs operating in
compliance with the rule separately register at their remote dispensing
locations (86 FR 33861). This expanded opportunities for OTPs to
provide needed services in remote or underserved areas. Through use of
Substance Abuse Prevention and Treatment Block Grant (SABG) funds,
SAMHSA encouraged OTPs to establish medication units as a means of
making treatment more readily available, especially to those people in
remote, rural, or underserved areas. To further the goal of improving
and expanding access, the range of services that can be provided in
medication units are described in the proposed rule. Such services must
be delivered in accordance with the nondiscrimination provision at 42
U.S.C. 300x-57, which state that: ``No person shall on the ground of
sex (including, in the case of a woman, on the ground that the woman is
pregnant), or on the ground of religion, be excluded from participation
in, be denied the benefits of, or be subjected to discrimination under,
any program or activity funded in whole or in part with funds made
available under section 300x or 300x-21 of this title.''
I. Section 8.14--Suspension or Revocation of Certification
This section clarifies the actions that SAMHSA may take when
immediate intervention is necessary to protect the public's health or
safety. The proposed rule specifies the administrative actions
available to SAMHSA in the event that a program sponsor, or any
employee of an OTP has: been found guilty of misrepresentation in
obtaining certification; failed to comply with the Federal Opioid Use
Disorder treatment standards; failed to comply with reasonable requests
from SAMHSA or from an accreditation body for records; or refused a
reasonable request of a duly designated SAMHSA inspector, DEA
Inspector, State Inspector, or accreditation body representative for
permission to inspect the program or the program's operations or its
records.
J. Subpart F--Authorization To Increase Patient Limit to 275 Patients
This subpart is amended to change the format from a Question-and-
Answer style to a standard narrative text format. This is for
consistency with the format found throughout the proposed rule.
K. Section 8.610--Practitioner Eligibility Requirements for a 3-Year
275-Patient Limit
This section clarifies the 3-year limit to the 275-patient limit.
L. Section 8.635--What are the reporting requirements for practitioners
whose 275 request for patient limit is approved?
As of May 2022, there were 8,641 practitioners waivered at the 275-
level and of these, 5,905 were Doctors of Medicine and Doctors of
Osteopathic Medicine (MD/DOs). The proposed rule removes reporting
requirements for practitioners at this level. Practitioners have found
the submission of these reports to be burdensome and a disincentive to
treating a higher number of patients.\78\ As increasing numbers of
Americans lose their lives to overdose, it is essential to support
practitioners and to remove perceived disincentives or barriers to
treating more patients. In this way, the extent of the overdose crisis
as a result of the COVID-19 PHE outweighs the potential value of data
obtained from compliant reporters. The proposed rule removes reporting
requirements for those who are authorized to treat up to 275 patients
with buprenorphine. Rather than expect practitioners to submit reports,
SAMHSA will seek to work in partnership with other Federal agencies for
monitoring purposes.
---------------------------------------------------------------------------
\78\ Lanham, H.J., Papac, J., Olmos, D.I., Heydemann, E.L.,
Simonetti, N., Schmidt, S., & Potter, J.S. (2022). Survey of
Barriers and Facilitators to Prescribing Buprenorphine and Clinician
Perceptions on the Drug Addiction Treatment Act of 2000 Waiver. JAMA
network open, 5(5), e2212419. https://doi.org/10.1001/jamanetworkopen.2022.12419.
---------------------------------------------------------------------------
Further to this, reporting requirements are known to perpetuate
stigma towards MOUD and to potentially reduce prescribing of a life-
saving medication.\79\ Negative attitudes and beliefs toward use of
medications in treating OUD is common among healthcare professionals,
members of law enforcement and others in justice settings, in the wider
community, and even among persons with OUD themselves.\80\ Of primary
care physicians in a national survey, just over three quarters (77.5%)
perceived buprenorphine to be an effective treatment for OUD.\81\ Many
treatment programs and support groups discourage participants from
using medications, including MOUD.\82\ Young adults with OUD experience
difficulties obtaining or remaining on buprenorphine as a result of
stigma from healthcare providers, 12-step programs, residential
treatment programs, and
[[Page 77343]]
parents.\83\ Prejudice against MOUD even exists among specialist SUD
treatment providers. One 2020 national survey of residential OUD
treatment programs found that less than a third (29%) offered
maintenance treatment with buprenorphine-naloxone; many programs
actively discouraged the use of medication, which are the standard of
care, revealing that there is a vast knowledge gap about MOUD among
treatment providers.\84\
---------------------------------------------------------------------------
\79\ Pew Charitable Trusts (2019). Why Aren't More People With
Opioid Use Disorder Getting Buprenorphine? Available at: https://www.pewtrusts.org/en/research-and-analysis/articles/2019/07/31/why-arent-more-people-with-opioid-use-disorder-getting-buprenorphine.
\80\ Scorsone, K.L., Haozous, E.A., Hayes, L., & Cox, K.J.
(2020). Overcoming Barriers: Individual Experiences Obtaining
Medication-Assisted Treatment for Opioid Use Disorder. Qualitative
health research, 30(13), 2103-2117. https://doi.org/10.1177/1049732320938689.
\81\ McGinty, E.E., Stone, E.M., Kennedy-Hendricks, A.,
Bachhuber, M.A., & Barry, C.L. (2020). Medication for Opioid Use
Disorder: A National Survey of Primary Care Physicians. Annals of
internal medicine, 173(2), 160-162. https://doi.org/10.7326/M19-3975.
\82\ Beetham, T., Saloner, B., Gaye, M., Wakeman, S.E., Frank,
R.G., & Barnett, M.L. (2020). Therapies Offered at Residential
Addiction Treatment Programs in the United States. JAMA, 324(8),
804-806. https://doi.org/10.1001/jama.2020.8969.
\83\ Hadland, S.E., Park, T.W., & Bagley, S.M. (2018). Stigma
associated with medication treatment for young adults with opioid
use disorder: a case series. Addiction science & clinical practice,
13(1), 15. https://doi.org/10.1186/s13722-018-0116-2.
\84\ Beetham, T., Saloner, B., Gaye, M., Wakeman, S.E., Frank,
R.G., & Barnett, M.L. (2020). Therapies Offered at Residential
Addiction Treatment Programs in the United States. JAMA, 324(8),
804-806. https://doi.org/10.1001/jama.2020.8969.
---------------------------------------------------------------------------
Proposed changes to part 8 seek to reduce discriminatory attitudes
and beliefs, and to incorporate evidence-based principles on
practitioner autonomy, patient-centered decision making and
individualized care plans. This is in line with the chronic disease
model of care,\85\ and represents a departure from the prescriptive
model of care currently in place. In this way, The Department seeks to
support practitioners in providing evidence-based and compassionate
care to patients while also engaging them in recovery. This is an
essential means of reducing stigma among practitioners and community
members, while also positively addressing a patient's internalized
stigma.\86\
---------------------------------------------------------------------------
\85\ Grover, A., & Joshi, A. (2014). An overview of chronic
disease models: a systematic literature review. Global journal of
health science, 7(2), 210-227. https://doi.org/10.5539/gjhs.v7n2p210.
\86\ Idemudia, E.S., Olasupo, M.O., & Modibo, M.W. (2018).
Stigma and chronic illness: A comparative study of people living
with HIV and/or AIDS and people living with hypertension in Limpopo
Province, South Africa. Curationis, 41(1), e1-e5. https://doi.org/10.4102/curationis.v41i1.1879.
---------------------------------------------------------------------------
Request for Comments
The Department requests public comment on all aspects of the
proposed amendments to the regulations at 42 CFR part 8, Medications
for the Treatment of Opioid Use Disorder. The Department welcomes
public comment on any benefits or drawbacks of the proposed amendments
set forth above in this proposed rule. Of particular interest are
comments pertaining to: interim treatment; split dosing; telehealth;
and take home doses of methadone.
Public Participation
The Department seeks comment on all issues raised by the proposed
regulation, including any potential unintended adverse consequences.
Because of the large number of public comments normally received on
Federal Register documents, the Department is not able to acknowledge
or respond to them individually. In developing the final rule, the
Department will consider all comments that are received by the date and
time specified in the DATES section of the Preamble.
Because mailed comments may be subject to delays due to security
procedures, please allow sufficient time for mailed comments to be
received by the deadline in the event of delivery delays. Any
attachments submitted with electronic comments on www.regulations.gov
should be in Microsoft Word or Portable Document Format (PDF). Please
note that comments submitted by fax or email and those submitted after
the comment period deadline will not be accepted.
Regulatory Impact Analysis
The Department has examined the impact of the proposed rule as
required by Executive Order 12866 on Regulatory Planning and Review, 58
FR 51735 (October 4, 1993); Executive Order 13563 on Improving
Regulation and Regulatory Review, 76 FR 3821 (January 21, 2011);
Executive Order 13132 on Federalism, 64 FR 43255 (August 10, 1999);
Executive Order 13175 on Consultation and Coordination with Indian
Tribal Governments, 65 FR 67249 (November 9, 2000); Executive Order
13985 Advancing Racial Equity and Support for Underserved Communities
Through the Federal Government, 86 FR 7009 (January 25, 2021); the
Congressional Review Act, Public Law 104-121, sec. 251, 110 Stat. 847
(March 29, 1996); the Unfunded Mandates Reform Act of 1995, Public Law
104-4, 109 Stat. 48 (March 22, 1995); the Regulatory Flexibility Act,
Public Law 96-354, 94 Stat. 1164 (September 19, 1980); Executive Order
13272 on Proper Consideration of Small Entities in Agency Rulemaking,
67 FR 53461 (August 16, 2002); the Assessment of Federal Regulations
and Policies on Families, Public Law 105-277, sec. 654, 112 Stat. 2681
(October 21, 1998); and the Paperwork Reduction Act of 1995, Public Law
104-13, 109 Stat. 163 (May 22, 1995).
Statement of Need
This proposed rule is being issued to update part 8 in response to
increasing opioid overdose deaths, exacerbated by the COVID-19
pandemic.\87\ Across the United States in 2020, 9.5 million people aged
12 or older misused heroin or prescription pain relievers.\88\ The
percentage was highest among young adults aged 18 to 25 (4.1 percent or
1.4 million people), followed by adults aged 26 or older (3.4 percent
or 7.5 million people). It was lowest among adolescents aged 12 to 17
(1.6 percent or 396,000 people).\88\ These numbers likely underestimate
the true prevalence of opioid misuse and OUD, since the use of
illicitly manufactured fentanyl has not to date been considered in the
National Survey on Drug Use and Health (NSDUH) survey, and populations
likely to have high prevalence of opioid misuse and use disorder, such
as individuals in the criminal justice system, other institutionalized
settings, and individuals experiencing homelessness not living in
shelters are not included in the NSDUH.
---------------------------------------------------------------------------
\87\ Cartus AR, Li Y, Macmadu A, Goedel WC, Allen B,
Cerd[aacute] M, Marshall BDL. Forecasted and Observed Drug Overdose
Deaths in the US During the COVID-19 Pandemic in 2020. JAMA Netw
Open. 2022 Mar 1;5(3):e223418. doi: 10.1001/
jamanetworkopen.2022.3418. PMID: 35311967; PMCID: PMC8938716.
\88\ Substance Abuse and Mental Health Services Administration.
(2021). Key substance use and mental health indicators in the United
States: Results from the 2020 National Survey on Drug Use and Health
(HHS Publication No. PEP21-07-01-003, NSDUH Series H-56). Rockville,
MD: Center for Behavioral Health Statistics and Quality, Substance
Abuse and Mental Health Services Administration. Retrieved from
https://www.samhsa.gov/data/.
---------------------------------------------------------------------------
Further to this, there are important equity considerations
evidenced by the data. A recent analysis by the Centers for Disease
Control and Prevention (CDC) demonstrates high levels of overdose among
Black, American Indian and Alaska Native communities over the course of
the pandemic.\89\ This study showed that overdose death rates rose 44
percent in 2020 for Black people and 39 percent for American Indian and
Alaska Native people, compared with 22 percent for white people.\89\
Black youth ages 15 to 24 saw an 86 percent increase in overdose
deaths, the largest spike of any age or race group, while Black men 65
and older were nearly seven times as likely than white men to die from
an overdose.\89\ It was also found that Black people were less than
half as likely as white people to have received substance use
treatment.
---------------------------------------------------------------------------
\89\ Kariisa M, Davis NL, Kumar S, et al. Vital Signs: Drug
Overdose Deaths, by Selected Sociodemographic and Social
Determinants of Health Characteristics--25 States and the District
of Columbia, 2019-2020. MMWR Morb Mortal Wkly Rep 2022;71:940-947.
DOI: https://dx.doi.org/10.15585/mmwr.mm7129e2.
---------------------------------------------------------------------------
Research demonstrates that MOUD can reduce mortality from overdose
by up to 59% (based on results of multivariable Cox proportional
hazards models adjusted for age; sex; baseline
[[Page 77344]]
anxiety diagnosis; depression diagnosis; receipt of methadone,
buprenorphine, opioid, and benzodiazepine prescriptions in the 12
months before index nonfatal opioid overdose; and time-varying receipt
of opioid prescriptions, benzodiazepine prescriptions, withdrawal
management episode, and short- and long-term residential treatments
\90\), yet few people who may benefit from these medications have
immediate and sustained access to them.\91\
---------------------------------------------------------------------------
\90\ Larochelle MR, Bernson D, Land T, Stopka TJ, Wang N, Xuan
Z, Bagley SM, Liebschutz JM, Walley AY (2018). Medication for Opioid
Use Disorder After Nonfatal Opioid Overdose and Association With
Mortality: A Cohort Study. Ann Intern Med. Aug 7;169(3):137-145.
doi: 10.7326/M17-3107.
\91\ Winograd RP, Presnall N, Stringfellow E, Wood C, Horn P,
Duello A, Green L, Rudder T. (2019). The case for a medication first
approach to the treatment of opioid use disorder. Am J Drug Alcohol
Abuse. 2019;45(4):333-340. doi: 10.1080/00952990.2019.1605372. Epub
2019 May 14. PMID: 31084515.
---------------------------------------------------------------------------
The pattern of enrollment in programs providing methadone was
established in the latter part of the 20th century.\92\ Research
reveals that the rate of methadone treatment at that time was highest
in low income urban areas.\93\ These patterns have remained relatively
unchanged since the expansion of access to buprenorphine in 2002.
Research demonstrates that there are extensive `treatment deserts'
where there is little to no physical access to OTPs, especially in
rural areas.\94\ SAMHSA believes that proposed changes to part 8 will,
as described above, facilitate:
---------------------------------------------------------------------------
\92\ D'Aunno T, Pollack HA. (2002). Changes in methadone
treatment practices: results from a national panel study, 1988-2000.
JAMA. 2002;288(7):850-856. doi:10.1001/jama.288.7.850.
\93\ Strain EC, Stitzer ML, Liebson IA, Bigelow GE. (1994).
Comparison of buprenorphine and methadone in the treatment of opioid
dependence. Am J Psychiatry. 1994 Jul;151(7):1025-30. doi: 10.1176/
ajp.151.7.1025. PMID: 8010359.
\94\ Mitchell P, Samsel S, Curtin KM, Price A, Turner D, Tramp
R, Hudnall M, Parton J, Lewis D. (2022). Geographic disparities in
access to Medication for Opioid Use Disorder across US census tracts
based on treatment utilization behavior. Soc Sci Med. 2022
Jun;302:114992. doi: 10.1016/j.socscimed.2022.114992. Epub 2022 Apr
28. PMID: 35512612.
---------------------------------------------------------------------------
Enhanced access to medications for opioid use disorder,
such as through take home doses of methadone and extending interim
treatment to 180 days;
Changes to ensure updated language and terminology;
Clarification of standards applying to accreditation
bodies;
Revising Federal Opioid Use Disorder Treatment Standards;
and
Removing reporting requirements for practitioners approved
to treat up to 275 patients.
SAMHSA notes below that these changes are associated with limited
burden as the proposed rule does not substantially alter reporting or
accreditation activities. The changes proposed will support SAMHSA in
its role of overseeing accrediting bodies and OTPs, modernizing
language and expectations in response to current challenges and
anticipated future trends. SAMHSA invites comments on the assumptions
of costs and benefits identified below, including citations to any
publicly available studies or reports that could elucidate and improve
this analysis.
A. Executive Orders 12866 and 13563 and Related Executive Orders on
Regulatory Review
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects; distributive impacts; and equity). Executive Order 13563 is
supplemental to, and reaffirms the principles, structures, and
definitions governing regulatory review as established in, Executive
Order 12866.
This proposed rule is partially regulatory and partially
deregulatory. The Department estimates that because much of what is
being proposed does not substantially alter current practice as
implemented over the past 2 years under the COVID PHE, the proposed
rule will not result in significantly altered costs. Further to this,
the proposed rule creates efficiencies in service delivery and in
administration. These include strengthening the patient-practitioner
relationship in a manner that promotes efficient, evidence-based and
patient-centered care, updating accreditation procedures and providing
a stable regulatory environment. Additionally, the proposed rule makes
permanent some OTP treatment flexibilities implemented within the past
two years.
B. Executive Order 13985 Advancing Racial Equity and Support for
Underserved Communities Through the Federal Government
A recent analysis by the Centers for Disease Control and Prevention
(CDC) demonstrates high levels of overdose among Black, American Indian
and Alaska Native communities over the course of the pandemic.\95\
While these trends existed long before the COVID-19 PHE, this study
highlights that overdose death rates rose 44 percent in 2020 for Black
people and 39 percent for American Indian and Alaska Native people,
compared with 22 percent for white people.\95\ Black youth ages 15 to
24 saw an 86 percent increase in overdose deaths, the largest spike of
any age or race group, while Black men 65 and older were nearly seven
times as likely than white men to die from an overdose.\95\ It was also
found that Black people were less than half as likely as white people
to have received substance use treatment.
---------------------------------------------------------------------------
\95\ Kariisa M., Davis N.L., Kumar S., et al. Vital Signs: Drug
Overdose Deaths, by Selected Sociodemographic and Social
Determinants of Health Characteristics--25 States and the District
of Columbia, 2019-2020. MMWR Morb Mortal Wkly Rep 2022;71:940-947.
DOI: https://dx.doi.org/10.15585/mmwr.mm7129e2.
---------------------------------------------------------------------------
This disparity amplifies the importance of promoting person-
centered care that is culturally appropriate and responsive to patient
need, while also fostering a treatment environment that promotes and
sustains patient engagement. The proposed changes facilitate the
practitioner-patient relationship in a manner that espouses these
principles, while also expanding the reach of OTPs (through activities
such as mobile medication units) to physically engage communities that
are in need of intervention. Further to this, the proposed changes
promote examination of a patient's cultural needs as they engage in
treatment services. This is consistent with evidence-based and
culturally responsive paradigms of care.
The proposed changes also facilitate patient engagement through
removing, at the practitioner's discretion, the requirement to attend
an OTP each day. Indeed, the ability to provide unsupervised doses of
methadone early in treatment allows those with unstable access to
transportation, for example, to focus on recovery activities in their
own community. Evidence from the past two years demonstrates safety, as
well as high patient and practitioner satisfaction with take-home doses
of methadone. This is principally because unsupervised doses of
methadone allow individuals the opportunity to engage in employment or
other activities that are supportive of recovery and longer term
community involvement.
1. Cost-Benefit Analysis
a. Overview
The U.S. estimated economic cost of opioid use disorder ($471
billion) and fatal opioid overdose ($550 billion), prior to the
pandemic, totaled $1,021 billion.\96\ Among the 39 jurisdictions
[[Page 77345]]
reviewed in this analysis, combined costs of opioid use disorder and
fatal opioid overdose varied from $985 million in Wyoming to $72.6
billion in Ohio. Per capita combined costs varied from $1,204 in Hawaii
to $7,247 in West Virginia. States with high per capita combined costs
were located mainly in the Ohio Valley and New England. Across many
studies, reduced quality of life is the largest component of the cost
of opioid use disorder.\97\
---------------------------------------------------------------------------
\96\ Luo, F., Li, M., & Florence, C. (2021). State-Level
Economic Costs of Opioid Use Disorder and Fatal Opioid Overdose--
United States, 2017. MMWR. Morbidity and mortality weekly report,
70(15), 541-546. https://doi.org/10.15585/mmwr.mm7015a1.
\97\ Mitchell, S.G., Gryczynski, J., Schwartz, R.P., Myers,
C.P., O'Grady, K.E., Olsen, Y.K., & Jaffe, J.H. (2015). Changes in
Quality of Life following Buprenorphine Treatment: Relationship with
Treatment Retention and Illicit Opioid Use. Journal of psychoactive
drugs, 47(2), 149-157. https://doi.org/10.1080/02791072.2015.1014948.
---------------------------------------------------------------------------
A recent study showed that in the absence of treatment, 42,717
overdoses (4,132 fatal, 38,585 nonfatal) and 12,660 deaths were
estimated to occur in a cohort of 100,000 patients over 5 years.\98\ An
estimated reduction in overdoses was associated with methadone
treatment (10.7%), buprenorphine or naltrexone treatment (22.0%), and
medication treatment combined with psychotherapeutic interventions
(range, 21.0%-31.4%).\98\ Estimated decreased deaths were associated
with treatment with methadone (6%), buprenorphine or naltrexone
(13.9%), and the combination of medications and psychotherapy (16.9%).
When criminal justice costs were included, all forms of MOUD (with
buprenorphine, methadone, and naltrexone) were associated with cost
savings compared with no treatment, yielding savings of $25,000 to
$105,000 in lifetime costs per person.
---------------------------------------------------------------------------
\98\ Fairley M., Humphreys K., Joyce V.R., et al. (2021). Cost-
effectiveness of Treatments for Opioid Use Disorder. JAMA
Psychiatry. 2021;78(7):767-777. doi:10.1001/
jamapsychiatry.2021.0247.
---------------------------------------------------------------------------
McAdam-Marx et al. reported in 2010 that Medicaid beneficiaries
with opioid use disorder, physical dependence on opioids, or poisoning
had nearly triple the total medical costs adjusted for baseline sample
characteristics compared to beneficiaries matched by age, gender, and
state with no opioid misuse diagnosis ($23,556 vs. $8436; P <
0.001).\99\ The opioid dependence/abuse group (using an older version
of the Diagnostic and Statistical Manual of Mental Disorders) also had
higher prevalence of comorbidities, such as psychiatric disorders,
pain-related diagnoses, and other substance use conditions. While this
study considered overall cost, it did not address medication costs in
particular, or any impact treatment may have had on overall cost.
---------------------------------------------------------------------------
\99\ McAdam-Marx C., Roland C.L., Cleveland J., Oderda G.M.
(2010). Costs of opioid abuse and misuse determined from a Medicaid
database. J Pain Palliat Care Pharmacother. 2010 Mar;24(1):5-18.
doi: 10.3109/15360280903544877. PMID: 20345194.
---------------------------------------------------------------------------
OTPs provide comprehensive interventions including medications,
counseling and services designed to offer a whole-person approach to
care and ameliorate social determinants of health that contribute to
substance misuse. Numerous studies have demonstrated that treatment
with pharmacotherapy and counseling services can reduce overall
healthcare costs for patients with OUD.100 101 102 For
example, a 2019 analysis demonstrated that a comprehensive approach to
OUD treatment is associated with improved health and economic
outcomes.\103\ This study assessed patients with OUD treated at a
comprehensive primary care center (CCP) and other Maryland facilities
in a large state Medicaid program, and demonstrated cost savings with a
comprehensive approach to care. Compared to the non-CCP patient group
(n = 867), the CCP group (n = 131) had a higher 6-month buprenorphine
treatment retention rate (P < 0.001), fewer hospital stays in the 12-
month follow-up period (P = 0.005), and lower total cost (US$10,942 vs.
$13,097, P < 0.001) and hospital stay cost (US$1448 vs. $4265, P =
0.001).\103\ Other measures, including emergency department utilization
and cost, substance use-related cost, and non-buprenorphine pharmacy
cost, were not statistically different between the 2 groups. Results
suggested that patients, as well as the health care system, can benefit
from a comprehensive model of care for OUD with better treatment
retention, fewer hospital stays, and lower costs.
---------------------------------------------------------------------------
\100\ Murphy S.M., Polsky D. (2016). Economic Evaluations of
Opioid Use Disorder Interventions. Pharmacoeconomics. 2016
Sep;34(9):863-87. doi: 10.1007/s40273-016-0400-5. PMID: 27002518;
PMCID: PMC5572804.
\101\ Baser O., Chalk M., Fiellin D.A., Gastfriend D.R. (2011).
Cost and utilization outcomes of opioid-dependence treatments. Am J.
Manag Care. 2011 Jun;17 Suppl 8:S235-48. PMID: 21761950.
\102\ Lynch F.L., McCarty D., Mertens J., Perrin N.A., Green
C.A., Parthasarathy S., Dickerson J.F., Anderson B.M., Pating D.
(2014). Costs of care for persons with opioid dependence in
commercial integrated health systems. Addict Sci Clin Pract. 2014
Aug 14;9(1):16. doi: 10.1186/1940-0640-9-16. PMID: 25123823; PMCID:
PMC4142137.
\103\ Hsu Y.J., Marsteller J.A., Kachur S.G., Fingerhood M.I.
(2019). Integration of Buprenorphine Treatment with Primary Care:
Comparative Effectiveness on Retention, Utilization, and Cost.
Idemudia, E.S., Olasupo, M.O., & Modibo, M.W. (2018). Stigma and
chronic illness: A comparative study of people living with HIV and/
or AIDS and people living with hypertension in Limpopo Province,
South Africa. Curationis, 41(1), e1-e5. https://doi.org/10.4102/curationis.v41i1.1879.
---------------------------------------------------------------------------
These findings are consistent with a 2016 cross sectional study
that evaluated medical claims for Vermont Medicaid beneficiaries with
opioid dependence or addiction between 2008 and 2013. In their
analysis, Mohlman and colleagues determined that medication combined
with psychosocial counseling is associated with reduced general health
care expenditures and utilization, such as inpatient hospital
admissions and outpatient emergency department visits, for Medicaid
beneficiaries with opioid misuse.\104\ Two prior studies assessed data
from commercial health insurance claims on the overall health care
costs and utilization rates for those using MOUD compared to those
treated without MOUD.101 105 The first study found that over
a five-year period, members on MOUD had 50% lower total annual health
plan costs than those who had two or more visits to an addiction
treatment setting and no treatment, and 62% lower than those with zero
or one visit for addiction treatment and no intervention.\105\ The
other study found that after a six-month period, those on MOUD had
significantly lower overall annual health plan costs compared to those
with no medication ($10,192 vs. $14,353; p-value < 0.0001).\101\ The
difference was driven largely by lower inpatient services and non-
opioid-related outpatient services for the group receiving medication.
---------------------------------------------------------------------------
\104\ Mohlman M.K., Tanzman B., Finison K., Pinette M., Jones C.
Impact of Medication-Assisted Treatment for Opioid Addiction on
Medicaid Expenditures and Health Services Utilization Rates in
Vermont. J Subst Abuse Treat. 2016 Aug; 67:9-14. doi: 10.1016/
j.jsat.2016.05.002. Epub 2016 May 9. PMID: 27296656.
\105\ McCarty D., Perrin N.A., Green C.A., Polen M.R., Leo M.C.,
Lynch F. (2010). Methadone maintenance and the cost and utilization
of health care among individuals dependent on opioids in a
commercial health plan. Drug Alcohol Depend. 2010 Oct 1;111(3):235-
40. doi: 10.1016/j.drugalcdep.2010.04.018. PMID: 20627427; PMCID:
PMC2950212.
---------------------------------------------------------------------------
The regulatory impact analysis (RIA) outlined below, relies on data
provided to SAMHSA by OTP accreditation bodies for the year 2020-2021.
Pursuant to 42 CFR part 8, accreditation bodies and OTPs are required
to submit information to SAMHSA's Center for Substance Abuse Treatment
(CSAT). The annualized burden of information collection for OTPs and
accreditation bodies under the rule is set forth in the tables that
follow.
This proposed rule does not substantially alter reporting burden or
accreditation activities. The total number of burden hours reported in
[[Page 77346]]
2020-2021 for accreditation body respondents was approximately 394.70
hours. The total number of burden hours for OTP respondents during the
same period was 1,868.95 hours. The annual burden associated with this
rule and the associated forms was estimated to be 2,263.65 hours.
This analysis quantifies a few limited categories of paperwork-
related costs, but there are more substantive actions (with associated
costs and benefits) that would be necessary in the chain of cause and
effect between the rule's most direct effects and the health and
mortality consequences that are implied, above, as being potentially
large if this proposal is finalized. For instance, relative to the
appropriate analytic baseline (the future in the absence of the rule),
the proposed rule would facilitate the expansion of mobile methadone
units via their inclusion in operations, and such expansion would
entail both new use of resources (costs \106\) and then, contingent
upon such costs being incurred, the types of benefits described above.
As a further example, the accrual of health and overdose-mortality-
avoidance benefits due to removal of the one-year requirement for
opioid addiction before patient admission to an OTP would generally be
contingent upon increasing resource use associated with such admission.
---------------------------------------------------------------------------
\106\ It would be incorrect to interpret this analytic
discussion as implying that the proposed rule changes authorization
procedures for mobile methadone units.
---------------------------------------------------------------------------
b. Estimated Costs of Reporting Burdens for OTPs and Accreditation
Bodies
In developing its estimates of the potential costs of the proposed
regulation, the Department relied substantially on recent estimates of
burden and cost pertaining to requirements set forth in 42 CFR part 8.
Hourly labor costs involved in reporting requirements vary greatly
between programs. Based on wage estimates obtained from the U.S.
Department of Labor, Bureau of Labor Statistics, and Occupational
Employment Statistics website, it is estimated that employees involved
in complying with reporting requirements range from minimum wage
($7.25) clerical workers, to counselors averaging $22.14 an hour,
managers, licensed practical nurses and registered nurses averaging
$35.36 per hour, administrators averaging $52.58 per hour, and
physicians averaging $96.26 per hour. The estimated average hourly wage
for program personnel involved in reporting requirements, calculated as
a simple mean, is $42.71. Multiplying the estimated average hourly wage
by 2.0 to account for fringe benefits and overhead costs, an estimated
hourly labor cost of $85.42 is obtained. The cost to accreditation
bodies for applying for initial and ongoing approval with Form SMA-163,
as well as for complying with the reporting requirements under 42 CFR
8.4 and 8.6 may be estimated at $33,672.56, using the $85.42 hourly
cost figure. The estimated total annualized cost to the treatment
program respondents for preparing the Form SMA-162 and for complying
with other reporting requirements pursuant to 42 CFR 8.11, 8.24, 8.25,
8.26, and 8.28, using $85.42 as the hourly cost figure, is $16,140.11.
----------------------------------------------------------------------------------------------------------------
Preparation
Items time (hours) Cost/hour Total cost
----------------------------------------------------------------------------------------------------------------
Form SMA-163, compliance with the reporting requirements under 42 CFR 394.2 $85.42 $33,672.56
8.4 and 8.6..........................................................
Form SMA-162, compliance with other reporting requirements under 21 188.95 85.42 16,140.11
CFR 8.11, 8.24, 8.25, 8.26, and 8.28.................................
Form SMA-168, Exception Request and Record of Justification Under 42 2,135 85.42 182,371.70
CFR 8.11(h)..........................................................
-----------------------------------------
Subtotal.......................................................... .............. ........... 232,184.37
----------------------------------------------------------------------------------------------------------------
c. Cost Pertaining to Recordkeeping
The recordkeeping requirements set forth in 42 CFR 8.4 and 8.12
include maintenance of the following: a patient's medical examination
when admitted to treatment; a patient's history; a care plan; any
prenatal support provided to the patient; justification of unusually
large initial doses; changes in a patient's dosage schedule; the
rationale for decreasing a patient's clinic attendance; services
provided; and documentation of physiologic tolerance.
SAMHSA believes that the recordkeeping requirements are customary
and usual practices within the medical and behavioral health treatment
communities. Accreditation bodies also maintain accreditation records
for 5 or more years as a customary and usual practice. SAMHSA has
neither calculated a response burden nor a cost burden for these
activities.
d. Costs Pertaining to Disclosure
The proposed rule includes requirements that OTPs and accreditation
organizations disclose information. For example, Sec. 8.12(e)(1)
requires that a practitioner explain the facts concerning the use of
MOUD to each patient. This type of disclosure is consistent with common
medical practice and is not considered an additional burden. Further,
the rule requires, under Sec. 8.4(i)(1), that accreditation
organizations shall make public their fee structure. This type of
disclosure is standard business practice and is not considered a burden
in this analysis.
e. Estimate of Annualized Non-Hourly Cost Burden to Respondents
The proposed rule does not impose new capital or startup costs
beyond the normal office and laboratory equipment required for
achieving regulatory compliance. It is estimated that there are some
costs associated with preparation for the accreditation site visit
itself; assuming that OTP staff spend approximately 180 hours preparing
for the site visit at an average cost of $85.42 per hour and an average
of 1.33 site visits per facility, the total cost would be $20,450 or an
annualized cost of $15,376 per facility. For the current approximately
1,920 affected OTPs these total annual costs are estimated to be
$29,521,920. The percentage of this total cost that is associated with
recordkeeping and reporting-only is difficult to estimate, but it is
considered to be a small fraction of the total associated with
accreditation.
i. Estimate of Annualized Cost to the Government
The total annualized cost to SAMHSA for administering 42 CFR part 8
is estimated at $450,000. This estimate includes the cost of an outside
contractor to develop and maintain an extensive on-line system for
SAMHSA,
[[Page 77347]]
opioid treatment programs, State opioid treatment authorities,
accreditation organizations, and others to have use a protected website
for day-to-day regulatory activities. This estimate does not include
funds that SAMHSA/CSAT allocates to its ``look back'' program that
monitors the adequacy of accreditation surveys. Of this amount, the
total annualized cost to SAMHSA for Paperwork Reduction Act activities
as a result of this regulation is estimated as $221,434, as shown in
the following table.
Annualized Cost to SAMHSA/CSATT
----------------------------------------------------------------------------------------------------------------
Total cost
Item (purpose) Responses Hours per Total @$85.42 per
response hours hour
----------------------------------------------------------------------------------------------------------------
SMA-162 (New Programs)..................................... 42 1.5 63 $5,381
SMA-162 (Renewal).......................................... 386 .75 289.5 24,729
SMA-162 (Relocation)....................................... 35 .25 8.75 747
Notification of Provisional Certification.................. 40 .50 20 1,708
Notification of Extension of Provisional Certification..... 15 .50 7.5 641
Notification of Sponsor or Medical Director Change......... 60 0.33 19.8 1,691
Documentation to SAMHSA for Interim Treatment.............. 1 0.50 0.5 43
Requests to SAMHSA for Exemption from Sec. Sec. 8.11 and 24,000 0.07 1680 143,506
8.12 (including SMA-168)..................................
Notification to SAMHSA Before Establishing Medication Units 20 1.00 20 1,708
Review of Submissions under Part C......................... 2 2.00 4 342
Accreditation Body Initial Application (SMA-163)........... 3 40 120 10,250
Accreditation Body Renewal (SMA-163)....................... 3 40 120 10,250
Relinquishment Notification................................ 1 .50 0.5 43
Notification for Serious Non-Compliant Programs............ 2 .50 1 85
General Documents to SAMHSA Upon Request................... 10 1.00 10 854
Accreditation Survey to SAMHSA Upon Request................ 383 .50 191.5 16,358
Less Than Full Accreditation Report to SAMHSA.............. 10 1.00 10 854
Summaries of Inspections................................... 12 1.00 12 1,025
Notification of Complaints to SAMHSA....................... 10 1.00 10 854
Submission of 90-Day Corrective Plan to SAMHSA............. 1 4.25 4.25 363
----------------------------------------------------
Subtotal............................................... 25,036 97.15 2592.3 221,434
----------------------------------------------------------------------------------------------------------------
2. Consideration of Regulatory Alternatives
The Department has initiated rulemaking to make flexibilities
issued during the COVID-19 PHE permanent, while also updating
accreditation and treatment standards to reflect evidence-based
practices and current medical terminology and approaches to OUD
treatment given the current overdose crisis. The alternative would be
to allow the current flexibilities to lapse with the end of the COVID-
19 PHE, or to renew them periodically as may be needed during future
emergencies or changed circumstances.
3. Request for Comments on Costs and Benefits
The Department requests public comment on all the estimates,
assumptions, and analyses within the cost-benefits analysis. As part of
this request, feedback is welcome on the extent to which cited papers
follow sound scientific practices, such as: clearly stating null
hypotheses and presenting estimating equations; ensuring that
appendices or other supplementary materials are available online, if
claimed to be so in the main body of a paper; using compelling
identification strategies if making causal claims (for example,
establishing parallel trends pre-intervention if using a difference-in-
differences method \107\); and avoiding the types of errors that Kim et
al. (2020 \108\) and Sanders et al. (2016 \109\) indicate are common in
published cost-effectiveness analyses. The Department also requests
comments on any relevant information or data that would inform a
quantitative analysis of proposed reforms that the Department
qualitatively addresses in this RIA. The Department also requests
comments on whether there may be other indirect costs and benefits
resulting from the proposed changes in the proposed rule and welcomes
additional information that may help quantify those costs and benefits.
---------------------------------------------------------------------------
\107\ Wing C, Simon K, Bello-Gomez RA (2018). Designing
difference in difference studies: best practices for public health
policy research. Annual Review of Public Health 39: 453-469.
\108\ Kim DD, Silver MC, Kunst N, et al. (2020). Perspective and
costing in cost-effectiveness analysis, 1974-2018. PharmacoEconomics
38: 1135-1145.
\109\ Sanders GD, Neumann PJ, Basu A, et al. (2016).
Recommendations for conduct, methodological practices, and reporting
of cost-effectiveness analyses: second panel on cost-effectiveness
in health and medicine, JAMA, 1093-1103.
---------------------------------------------------------------------------
B. Regulatory Flexibility Act
The Department has examined the economic implications of this
proposed rule as required by the Regulatory Flexibility Act (5 U.S.C.
601-612). If a rule has a significant economic impact on a substantial
number of small entities, the Regulatory Flexibility Act (RFA) requires
agencies to analyze regulatory options that would lessen the economic
effect of the rule on small entities. For purposes of the RFA, small
entities include small businesses, nonprofit organizations, and small
governmental jurisdictions. The Act defines ``small entities'' as (1) a
proprietary firm meeting the size standards of the Small Business
Administration (SBA), (2) a nonprofit organization that is not dominant
in its field, and (3) a small government jurisdiction of less than
50,000 population. Because 90 percent or more of all health care
providers meet the SBA size standard for a small business or are
nonprofit organizations, the Department generally treats all health
care providers as small entities for purposes of performing a
regulatory flexibility analysis. The SBA size standard for health care
providers ranges between a maximum of $8 million and $41.5 million in
annual receipts, depending upon the type of entity.
For the reasons stated above, it is not expected that the cost of
compliance would be significant for OTPs or accreditation bodies.
Therefore, this
[[Page 77348]]
proposed rule would not result in a significant negative impact.
C. Unfunded Mandates Reform Act
Section 202(a) of The Unfunded Mandates Reform Act of 1995 (UMRA)
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending that may result in
expenditures in any one year of $100 million in 1995 dollars, updated
annually for inflation. As of 2022, this threshold is $165 million. The
Department does not anticipate that this proposed rule would result in
the expenditure by state, local, and tribal governments, taken
together, or by the private sector, of $165 million or more in any one
year.
D. Executive Order 13132--Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on state
and local governments, preempts state law, or otherwise has federalism
implications. The Department does not believe that this rulemaking
would have any significant federalism implications, impose significant
costs on state or local governments or preempt state law.
E. Assessment of Federal Regulation and Policies on Families
Section 654 of the Treasury and General Government Appropriations
Act of 1999 \110\ requires Federal departments and agencies to
determine whether a proposed policy or regulation could affect family
well-being. If the determination is affirmative, then the Department or
agency must prepare an impact assessment to address criteria specified
in the law. The Department believes that the proposed regulations would
positively impact the ability of patients and families to access
treatment for OUD. The Department does not anticipate negative impacts
on family well-being as a result of this rulemaking as described.
---------------------------------------------------------------------------
\110\ Public Law 105-277, 112 Stat. 2681 (October 21, 1998).
---------------------------------------------------------------------------
F. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (Pub. L. 104-13),
agencies are required to submit to the Office of Management and Budget
(OMB) for review and approval any reporting or recordkeeping
requirements inherent in a proposed or final rule, and are required to
publish such proposed requirements for public comment. The PRA requires
agencies to provide a 60-day notice in the Federal Register and solicit
public comment on a proposed collection of information before it is
submitted to OMB for review and approval. To fairly evaluate whether an
information collection should be approved by OMB, section 3506(c)(2)(A)
of the PRA requires that the Department solicit comment on the
following issues:
1. Whether the information collection is necessary and useful to
carry out the proper functions of the agency;
2. The accuracy of the agency's estimate of the information
collection burden;
3. The quality, utility, and clarity of the information to be
collected; and
4. Recommendations to minimize the information collection burden on
the affected public, including automated collection techniques.
The PRA requires consideration of the time, effort, and financial
resources necessary to meet the information collection requirements
referenced in this section. The Department explicitly seeks, and will
consider, public comment on its assumptions as they relate to the PRA
requirements summarized in this section.
As discussed below, the Department estimates a total OTP burden
associated with all information collections of 1,868.95 hours, and a
total number of burden hours for accreditation body respondents of
approximately 394.70 hours each year. The annual burden associated with
this rule and the associated forms is therefore estimated to be
2,263.65 hours.
1. Explanation of Estimated Annualized Burden Hours for 42 CFR Part 8
The Department presents, in separate tables below, burden estimates
for the annual reporting requirement for accreditation bodies and also
OTPs pursuant to the proposed rule.
Estimated Annual Reporting Requirement Burden for Accreditation Bodies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Total Hours/ Total
42 CFR citation Purpose respondents respondent Responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3(b)(1) through (11)....................... Initial approval (SMA-163).......... 1 1 1 6.0 6
8.3(c)....................................... Renewal of approval (SMA-163)....... 2 1 2 1.0 2
8.3(e)....................................... Relinquishment notification......... 1 1 1 0.5 0.5
8.3(f)(2).................................... Non-renewal notification to 1 90 90 0.1 9
accredited OTPs.
8.4(b)(1)(ii)................................ Notification to SAMHSA for seriously 2 2 4 1.0 4
noncompliant OTPs.
8.4(b)(1)(iii)............................... Notification to OTP for serious 2 10 20 1.0 20
noncompliance.
8.4(d)(1).................................... General documents and information to 6 5 30 0.5 15
SAMHSA upon request.
8.4(d)(2).................................... Accreditation survey to SAMHSA upon 6 75 450 0.02 9
request.
8.4(d)(3).................................... List of surveys, surveyors to SAMHSA 6 6 36 0.2 7.2
upon request.
8.4(d)(4).................................... Report of less than full 6 5 30 0.5 15
accreditation to SAMHSA.
8.4(d)(5).................................... Summaries of Inspections............ 6 50 300 0.5 150
8.4(e)....................................... Notifications of Complaints......... 12 6 72 0.5 36
8.6(a)(2) and (b)(3)......................... Revocation notification to 1 185 185 0.3 55.5
Accredited OTPs.
8.6(b)....................................... Submission of 90-day corrective plan 1 1 1 10 10.0
to SAMHSA.
8.6(b)(1).................................... Notification to accredited OTPs of 1 185 185 0.3 55.5
Probationary Status.
--------------------------------------------------------------------
Subtotal................................. .................................... 54 ............ 1,407 ........... 394.70
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Total Hours/
42 CFR citation Purpose respondents respondent responses response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.11(b)...................................... Renewal of approval (SMA-162)....... 386 1 386 0.15 57.9
8.11(b)...................................... Relocation of Program (SMA-162)..... 35 1 35 1.17 40.95
[[Page 77349]]
8.11(d)...................................... Application for provisional 42 1 42 1 42.00
certification.
8.11(f)...................................... Application for extension of 30 1 30 0.25 7.50
provisional certification.
8.11(g)(5)................................... Notification of sponsor or medical 60 1 60 0.1 6.00
director change (SMA-162).
8.11(h)(2)................................... Documentation to SAMHSA for interim 1 1 1 1 1.00
treatment.
8.11(i)...................................... Request to SAMHSA for Exemption from 1,200 20 24,000 0.07 1,680
Sec. Sec. 8.11 and 8.12
(including SMA-168).
8.11(j)(1)................................... Notification to SAMHSA Before 10 1 10 0.25 2.5
Establishing Medication Units (SMA-
162).
8.12(j)(2)................................... Notification to State Opioid 1 20 20 0.33 6.6
Treatment Authority for Interim
Treatment.
8.24......................................... Contents of Appellant Request for 2 1 2 0.25 .50
Review of Suspension.
8.25(a)...................................... Informal Review Request............. 2 1 2 1.00 2.00
8.26(a)...................................... Appellant's Review File and Written 2 1 2 5.00 10.00
Statement.
8.28(a)...................................... Appellant's Request for Expedited 2 1 2 1.00 2.00
Review.
--------------------------------------------------------------------
8.28(c)...................................... Appellant Review File and Written 2 1 2 5.00 10.00
Statement.
--------------------------------------------------------------------
Subtotal................................. .................................... 1,775 ............ 24,594 ........... 1,868.95
Total................................ .................................... 1,829 ............ 26,001 ........... 2,263.65
--------------------------------------------------------------------------------------------------------------------------------------------------------
The tables above reflect current estimates of burden, as the
proposed rule does not effectively add or alter new reporting
requirements. The estimates are derived from SAMHSA's data and are
reflective of work from over the preceding twelve months. Further to
this, the estimates of burden do not substantially differ from
previously submitted estimates provided to The Office of Management and
Budget.
The proposed rule does not alter reporting requirements as these
have been shown to be effective in the safe administration of OTPs. The
accreditation system provides effective oversight, while OTP reporting
requirements support accreditation activities and the provision of safe
treatment. Further to this, the proposed rule retains requirements that
OTP's and accreditation organizations disclose information related to
patient care and clinic policies and procedures for the treatment of
OUD with MOUD. For example, Sec. 8.12(e)(1) requires that a qualifying
health care practitioner explain the facts concerning the use of MOUD
to each patient. This type of disclosure is considered to be consistent
with common medical practice and is not considered an additional
burden. Further, the requirement under Sec. 8.4(i)(1) that each
accreditation organization shall make public its fee structure is
considered standard business practice and is not considered a burden in
this analysis.
List of Subjects in 42 CFR Part 8
Administrative practice and procedure, Health professions,
Methadone, Reporting and recordkeeping requirements, Substance misuse.
0
For the reasons stated in the preamble, the Department of Health and
Human Services proposes to revise 42 CFR part 8 to read as set forth
below:
PART 8--MEDICATIONS FOR THE TREATMENT OF OPIOID USE DISORDER
Subpart A--General Provisions
Sec.
8.1 Scope.
8.2 Definitions.
Subpart B--Accreditation of Opioid Treatment Programs
8.3 Application for approval as an accreditation body.
8.4 Accreditation body responsibilities.
8.5 Periodic evaluation of accreditation bodies.
8.6 Withdrawal of approval of accreditation bodies.
Subpart C--Certification and Treatment Standards for Opioid Treatment
Programs
8.11 Opioid Treatment Program certification.
8.12 Federal Opioid Use Disorder treatment standards.
8.13 Revocation of accreditation and accreditation body approval.
8.14 Suspension or revocation of certification.
8.15 Forms.
Subpart D--Procedures for Review of Suspension or Proposed Revocation
of OTP Certification, and of Adverse Action Regarding Withdrawal of
Approval of an Accreditation Body
8.21 Applicability.
8.22 Definitions.
8.23 Limitation on issues subject to review.
8.24 Specifying who represents the parties.
8.25 Informal review and the reviewing official's response.
8.26 Preparation of the review file and written arguments.
8.27 Opportunity for oral presentation.
8.28 Expedited procedures for review of immediate suspension.
8.29 Ex parte communications.
8.30 Transmission of written communications by reviewing official
and calculation of deadlines.
8.31 Authority and responsibilities of the reviewing official.
8.32 Administrative record.
8.33 Written decision.
8.34 Court review of final administrative action; exhaustion of
administrative remedies.
Subpart E [Reserved]
Subpart F--Authorization To Increase Patient Limit to 275 Patients
8.610 Practitioner eligibility requirements for a 3-year 275-patient
limit.
8.615 Definition of a qualified practice setting.
8.620 Applying for a 275-patient limit.
8.625 Processing a 275 Request for Patient Limit Increase.
8.630 Practitioner requirements to maintain a 275-patient limit.
8.640 Renewal process for a 3-year 275 Request for Patient Limit
Increase.
8.645 Practitioner responsibility when no renewal request for
patient limit increase is submitted, or whose renewal request is
denied.
8.650 Suspension or revocation of the Secretary's approval of a
practitioner's request for patient limit increase.
8.655 Temporary increase to treat up to 275 patients in emergency
situations.
Authority: 21 U.S.C. 823; 42 U.S.C. 257a, 290aa(d), 290dd-2,
300x-23, 300x-27(a), 300y-11.
Subpart A--General Provisions
Sec. 8.1 Scope.
(a) This subpart and subparts B through D of this part establish
the procedures by which the Secretary of Health and Human Services (the
Secretary) will determine whether an
[[Page 77350]]
applicant seeking to become an Opioid Treatment Program (OTP) is
qualified under section 303(g) of the Controlled Substances Act (CSA)
(21 U.S.C. 823(g)(1)) to dispense Medications for Opioid Use Disorder
(MOUD) in the treatment of Opioid Use Disorder (OUD), and establishes
the Secretary's standards regarding the appropriate quantities of MOUD
that may be provided for unsupervised use by individuals undergoing
such treatment (21 U.S.C. 823(g)(1)). Under this subpart and subparts B
through D, an applicant seeking to become an OTP must first obtain from
the Secretary or, by delegation, from the Assistant Secretary for
Mental Health and Substance Use, a certification that the applicant is
qualified under the Secretary's standards and will comply with such
standards. Eligibility for certification will depend upon the applicant
obtaining accreditation from an accreditation body that has been
approved by the Secretary. This subpart and subparts B through D also
establish the procedures whereby an entity can apply to become an
approved accreditation body, and the requirements and general standards
for accreditation bodies to ensure that OTPs are consistently evaluated
for compliance with the Secretary's standards for treatment of OUD with
MOUD.
(b) The regulations in subpart F of this part establish the
procedures and requirements that practitioners who are authorized to
treat up to 100 patients with OUD pursuant to a waiver obtained under
section 303(g)(2) of the CSA (21 U.S.C. 823(g)(2)), must satisfy in
order to treat up to 275 patients with medications covered under
section 303(g)(2)(C) of the CSA.
Sec. 8.2 Definitions.
The following definitions apply to this part:
Accreditation body means an organization that has been approved by
the Secretary in this part to accredit OTPs dispensing MOUD.
Accreditation body application means the application filed with the
Secretary for purposes of obtaining approval as an accreditation body,
as described in Sec. 8.3(b).
Accreditation elements mean the elements or standards that are
developed and adopted by an accreditation body and approved by the
Secretary.
Accreditation survey means an onsite review and evaluation of an
OTP by an accreditation body for the purpose of determining compliance
with the Federal opioid treatment standards described in Sec. 8.12.
Accredited OTP means an OTP that is the subject of a current, valid
accreditation from an accreditation body approved by the Secretary
under Sec. 8.3(d).
Additional credentialing means board certification in Addiction
Medicine or Addiction Psychiatry by the American Board of Addiction
Medicine, the American Board of Medical Specialties, or the American
Osteopathic Association or certification by the American Board of
Addiction Medicine, the American Society of Addiction Medicine.
Approval term means the 3-year period in which a practitioner is
approved to treat up to 275 patients with OUD that commences when a
practitioner's Request for Patient Limit Increase is approved in
accordance with Sec. 8.625.
Behavioral health services means any intervention carried out in a
therapeutic context at an individual, family, or group level.
Interventions may include structured, professionally administered
clinical interventions (e.g., cognitive behavior therapy or insight-
oriented psychotherapy) delivered in-person, or remotely via
telemedicine, which has been shown to facilitate treatment outcomes, or
non-clinical interventions.
Care plan means an individualized treatment and/or recovery plan
that outlines attainable treatment goals that have been identified and
agreed upon between the patient and the OTP clinical team, and which
specifies the services to be provided, as well as the proposed
frequency and schedule for their provision.
Certification means the process by which the Secretary determines
that an OTP is qualified to provide OUD treatment under the Federal
Opioid Use Disorder treatment standards.
Certification application means the application filed by an OTP for
purposes of obtaining certification from the Secretary, as described in
Sec. 8.11(b).
Certified opioid treatment program means an OTP that is the subject
of a current, valid certification under Sec. 8.11.
Comprehensive treatment is treatment that includes the continued
use of MOUD provided in conjunction with an individualized range of
appropriate harm reduction, medical, behavioral health, and recovery
support services.
Conditional certification is a type of temporary certification
granted to an OTP that has requested renewal of its certification and
that has received temporary accreditation for one year by an approved
accreditation body. The one-year accreditation period is to allow the
OTP to address areas of non-conformance with accreditation standards
that do not involve immediate, high-risk health and/or safety concerns.
Continuous medication treatment means the uninterrupted treatment
for OUD involving the dispensing and administration of MOUD at stable
dosage levels for a period in excess of 21 days.
Covered medications means the medications or combinations of such
medications that are covered under 21 U.S.C. 823(g)(2)(C).
Dispense means to deliver a controlled medication to an ultimate
user by, or pursuant to, the lawful order of, a practitioner, including
the prescribing and administering of a controlled medication.
Diversion control plan means a set of documented procedures that
reduce the possibility that controlled medications will be transferred
or otherwise shared with others to whom the medication was not
prescribed or dispensed.
Emergency situation means that an existing State, tribal, or local
system for substance use disorder services is overwhelmed or unable to
meet the existing need for the provision of MOUD as a direct
consequence of a clear precipitating event. This precipitating event
must have an abrupt onset, such as: practitioner incapacity; natural or
human-caused disaster; an outbreak associated with drug use; and result
in significant death, injury, exposure to life-threatening
circumstances, hardship, suffering, loss of property, or loss of
community infrastructure.
Federal Opioid Use Disorder treatment standards means the standards
established by the Secretary in Sec. 8.12 that are used to determine
whether an OTP is qualified to engage in OUD treatment. The Federal
Opioid Use Disorder treatment standards established in Sec. 8.12 also
include the standards established by the Secretary regarding the
quantities of MOUD which may be provided for unsupervised use.
For-cause inspection means an inspection, by the Secretary, an
accreditation body, or a State authority, of an OTP that may be
operating in violation of Federal Opioid Use Disorder treatment
standards, may be providing substandard treatment, may be serving as a
possible source of diverted medications, or where patient well-being is
at risk.
Harm reduction refers to practical, evidence-based strategies,
including: overdose education; testing and intervention for infectious
diseases,
[[Page 77351]]
including counseling and risk mitigation activities forming part of a
comprehensive, integrated approach to address human immunodeficiency
virus (HIV), viral hepatitis, sexually transmitted infections, and
bacterial and fungal infections; distribution of opioid overdose
reversal medications; linkage to other public health services; and
connecting those who have expressed interest in additional support to
peer services.
Individualized dose means the dose of a medication for opioid use
disorder, ordered by an OTP practitioner and dispensed to a patient,
that sufficiently suppresses opioid withdrawal symptoms. Individualized
doses may also include split doses of a medication for opioid use
disorder, where such dosing regimens are indicated.
Interim treatment means that on a temporary basis, a patient may
receive services from an OTP, while awaiting access to more
comprehensive treatment services. The duration of interim treatment is
limited to 180 days.
Long-term care facilities mean those facilities that provide
rehabilitative, restorative, and/or ongoing services to those in need
of assistance with activities of daily living. Long-term care
facilities include: extended acute care facilities; rehabilitation
centers; skilled nursing facilities; permanent supportive housing;
assisted living facilities; and chronic care hospitals.
Medical director means a physician, licensed to practice medicine
in the jurisdiction in which the OTP is located, who assumes
responsibility for all medical and behavioral health services provided
by the program, including their administration. A medical director may
delegate specific responsibilities to authorized program physicians,
appropriately licensed non-physician practitioners with prescriptive
authority functioning under the medical director's supervision, or
appropriately licensed and/or credentialed non-physician healthcare
professionals providing services in the OTP, in compliance with
applicable Federal and State laws. Such delegations will not eliminate
the medical director's responsibility for all medical and behavioral
health services provided by the OTP.
Medication for Opioid Use Disorder or MOUD means medications,
including opioid agonist medications, approved by the Food and Drug
Administration under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355), for use in the treatment of OUD. As used
in this part, ``continuous medication treatment'' is intended to be
synonymous with the term ``maintenance'' treatment as used in 21 U.S.C.
823(g)(1), and the term ``withdrawal management'' is intended to be
synonymous with the term ``detoxification'' as used in 21 U.S.C.
823(g)(1).
Medication unit means an entity that is established as part of, but
geographically separate from, an OTP from which appropriately licensed
OTP practitioners, contractors working on behalf of the OTP, or
community pharmacists may dispense or administer MOUD, collect samples
for drug testing or analysis, or provide other OTP services. Medication
units can be a brick-and-mortar location or mobile unit.
Nationally recognized evidence-based guidelines mean a document
produced by a national or international medical professional
association, public health agency, such as the World Health
Organization, or governmental body with the aim of assuring the
appropriate use of evidence to guide individual diagnostic and
therapeutic clinical decisions for the management of OUD and other
health conditions that are widely recognized within the United States.
Opioid Treatment Program or OTP means a program engaged in OUD
treatment of individuals with MOUD registered under 21 U.S.C.
823(g)(1).
Opioid Treatment Program certification means the process by which
the Secretary determines that an OTP applicant is qualified to provide
Opioid Use Disorder treatment under the Federal Opioid Use Disorder
treatment standards described in Sec. 8.12.
Opioid Use Disorder means a cluster of cognitive, behavioral, and
physiological symptoms associated with a problematic pattern of opioid
use that continues despite clinically significant impairment or
distress within a 12-month period.
Opioid Use Disorder treatment means the dispensing of MOUD, along
with the provision of a range of medical and behavioral health
services, as clinically necessary and based on an individualized
assessment and a mutually agreed-upon care plan, to an individual to
alleviate the combination of adverse medical, psychological, or
physical effects associated with an OUD.
Patient, for purposes of subparts B through D of this part, means
any individual who receives continuous treatment or withdrawal
management in an OTP. The word patient encompasses client, person in
treatment, or any other definition accepted by the treatment community
or those with lived experience. For purposes of subpart F of this part,
patient means any individual who is dispensed or prescribed covered
medications by a practitioner.
Patient limit means the maximum number of individual patients that
a practitioner may dispense or prescribe covered medications to at any
one time.
Physical and behavioral health services include services such as
medical and psychiatric screening, assessments, evaluations,
examinations, and interventions, counseling, health education, peer
support services, and social services (e.g., vocational and educational
guidance, employment training), that are intended to help patients in
OTPs achieve and sustain remission and recovery.
Practitioner, for purposes of this subpart and subparts B through D
of this part, means a physician, physician assistant, nurse
practitioner, clinical nurse specialist, certified registered nurse
anesthetist, or certified nurse midwife who is appropriately licensed
by a State to prescribe and/or dispense medications for opioid use
disorder within an OTP. The term practitioner, for purposes of subpart
F of this part, means a physician, physician assistant, nurse
practitioner, clinical nurse specialist, certified registered nurse
anesthetist, or certified nurse midwife who is appropriately licensed
by a State to prescribe and/or dispense schedule III, IV, and V
medications for opioid use disorder, and who possesses a waiver under
21 U.S.C. 823(g)(2).
Practitioner incapacity means the inability of a practitioner as a
result of an involuntary event to physically or mentally perform the
tasks and duties required to provide OUD treatment in accordance with
nationally recognized evidence-based guidelines.
Program sponsor means the person named in the application for
certification described in Sec. 8.11(b) as responsible for the
operation of the OTP and who assumes responsibility for all its
employees, including any practitioners, agents, or other persons
providing medical, behavioral health, or social services at the program
or any of its medication units. The program sponsor need not be a
licensed physician but shall ensure that an actively licensed physician
occupies the position of medical director within an OTP.
Recovery support services means:
(1) Recovery is the process of change through which people improve
their health and wellness, live self-directed lives, and strive to
reach their full potential.
(2) Recovery support services can include, but are not limited to,
community-based recovery housing,
[[Page 77352]]
peer recovery support services, social support, linkage to and
coordination among allied service providers and a full range of human
services that facilitate recovery and wellness contributing to an
improved quality of life. The services extend the continuum of care by
strengthening and complementing substance use disorder (SUD) treatment
interventions in different settings and stages.
Split dosing means dispensing of a single dose of MOUD as separate
portions to be taken within a 24-hour period. Split dosing is indicated
among, but not limited to, those patients who: possess a genetic
variant which increases methadone metabolism; concurrently use other
medications or alcohol that also induce hepatic enzymes leading to more
rapid metabolism of methadone; who are pregnant; or for whom methadone
or buprenorphine are being used to treat a concurrent pain indication
in addition to the diagnosis of OUD. This leads to more stable, steady-
state medication levels.
State Opioid Treatment Authority (SOTA) is the agency designated by
the Governor of a State, or other appropriate official designated by
the Governor, to exercise the responsibility and authority within the
State or Territory for governing the treatment of OUD with MOUD in
OTPs.
Telehealth or telemedicine is the delivery and facilitation of
health and health-related services including medical care, counselling,
practitioner, provider and patient education, health information
services, and self-care via telecommunications and digital
communication technologies. This includes Health Insurance Portability
and Accountability Act (HIPAA)-compliant video and audio-only
communication platforms.
Withdrawal management means the dispensing of a MOUD in decreasing
doses to an individual to alleviate adverse physical effects incident
to withdrawal from the continuous or sustained use of an opioid and as
a method of bringing the individual to an opioid-free state within such
period. Long-term withdrawal management refers to the process of
medication tapering that exceeds 30 days.
Subpart B--Accreditation of Opioid Treatment Programs
Sec. 8.3 Application for approval as an accreditation body.
(a) Eligibility. Private nonprofit organizations, State or
territorial governmental entities, or political subdivisions thereof,
and Indian Tribes as defined by the Federally Recognized Indian Tribe
List Act of 1994, that are capable of meeting the requirements of this
part may apply for approval as an accreditation body.
(b) Application for initial approval. Electronic copies of an
accreditation body application form [SMA-167] shall be submitted to:
https://dpt2.samhsa.gov/sma163/. Accreditation body applications shall
include the following information and supporting documentation:
(1) Name, address, and telephone number of the applicant and a
responsible official for the accreditation body. The application shall
be signed by the responsible official;
(2) Evidence of the nonprofit status of the applicant (i.e., of
fulfilling Internal Revenue Service requirements as a nonprofit
organization) if the applicant is not a State or territorial
governmental entity, Indian Tribe, or political subdivision;
(3) A set of the accreditation elements or standards and a detailed
discussion showing how the proposed accreditation elements or standards
will ensure that each OTP surveyed by the applicant is qualified to
meet or is meeting each of the Federal opioid treatment standards set
forth in Sec. 8.12;
(4) A detailed description of the applicant's decision-making
process, including:
(i) Procedures for initiating and performing onsite accreditation
surveys of OTPs;
(ii) Procedures for assessing OTP personnel qualifications;
(iii) Copies of an application for accreditation, guidelines,
instructions, and other materials the applicant will send to OTPs
during the accreditation process, including a request for a complete
history of prior accreditation activities and a statement that all
information and data submitted in the application for accreditation is
true and accurate, and that no material fact has been omitted;
(iv) Policies and procedures for notifying OTPs and the Secretary
of deficiencies, for monitoring corrections of deficiencies by OTPs and
for reporting corrections to the Secretary;
(v) Policies and procedures for determining OTPs level of adherence
to this part and accrediting body standards and level of accreditation;
(vi) Policies and procedures for suspending or revoking an OTP's
accreditation;
(vii) Policies and procedures that will ensure processing of
applications for accreditation and applications for renewal of
accreditation within a timeframe approved by the Secretary; and
(viii) A description of the applicant's appeals process to allow
OTPs to contest adverse accreditation decisions;
(5) Policies and procedures established by the accreditation body
to avoid conflicts of interest, or the appearance of conflicts of
interest, by the applicant's board members, commissioners, professional
personnel, consultants, administrative personnel, and other
representatives;
(6) A description of the education, experience, and training
requirements for the applicant's professional staff, accreditation
survey team membership, and the identification of at least one licensed
physician with experience treating OUD with MOUD on the applicant's
staff;
(7) A description of the applicant's survey team training policies;
(8) Fee schedules, with supporting cost data;
(9) Satisfactory assurances that the body will comply with the
requirements of Sec. 8.4, including a contingency plan for
investigating complaints under Sec. 8.4(e);
(10) Policies and procedures established to protect confidential
information the applicant will collect or receive in its role as an
accreditation body; and
(11) Any other supporting information the Secretary may require.
(c) Application for renewal of approval. An accreditation body that
intends to continue to serve as an accreditation body beyond its
current term shall apply to the Secretary for renewal, or notify the
Secretary of its intention not to apply for renewal, in accordance with
the following procedures and schedule:
(1) At least 9 months before the date of expiration of an
accreditation body's term of approval, the body shall inform the
Secretary in writing of its intent to seek renewal.
(2) The Secretary will notify the applicant of the relevant
information, materials, and supporting documentation required under
paragraph (b) of this section that the applicant shall submit as part
of the renewal procedure.
(3) At least 3 months before the date of expiration of the
accreditation body's term of approval, the applicant shall send to the
Secretary electronically a renewal application containing the
information, materials, and supporting documentation requested by the
Secretary under paragraph (c)(2) of this section.
(4) An accreditation body that does not intend to renew its
approval shall so
[[Page 77353]]
notify the Secretary at least 9 months before the expiration of the
body's term of approval.
(d) Rulings on applications for initial approval or renewal of
approval. (1) the Secretary will grant an application for initial
approval or an application for renewal of approval if it determines the
applicant substantially meets the accreditation body requirements of
this subpart.
(2) If the Secretary determines that the applicant does not
substantially meet the requirements set forth in this subpart, the
Secretary will notify the applicant of the deficiencies in the
application and request that the applicant resolve such deficiencies
within 90 days of receipt of the notice. If the deficiencies are
resolved to the satisfaction of the Secretary within the 90-day time
period, the body will be approved as an accreditation body. If the
deficiencies have not been resolved to the satisfaction of the
Secretary within the 90-day time period, the application for approval
as an accreditation body will be denied.
(3) If the Secretary does not reach a final decision on a renewal
application before the expiration of an accreditation body's term of
approval, the approval will be deemed extended until the Secretary
reaches a final decision, unless an accreditation body does not rectify
deficiencies in the application within the specified time period, as
required in paragraph (d)(2) of this section.
(e) Relinquishment of approval. An accreditation body that intends
to relinquish its accreditation approval before expiration of the
body's term of approval shall submit a letter of such intent to the
Secretary, at the address in paragraph (b) of this section, at least 9
months before relinquishing such approval.
(f) Notification. An accreditation body that does not apply for
renewal of approval, or is denied such approval by the Secretary,
relinquishes its accreditation approval before expiration of its term
of approval, or has its approval withdrawn, shall:
(1) Transfer copies of records and other related information as
required by the Secretary to a location, including another
accreditation body, and according to a schedule approved by the
Secretary; and
(2) Notify, in a manner and time period approved by the Secretary,
all OTPs accredited or seeking accreditation by the body that the body
will no longer have approval to provide accreditation services.
(g) Term of approval. An accreditation body's term of approval is
for a period not to exceed 5 years.
(h) State, territorial, or Indian Tribe accreditation bodies.
State, territorial, and Indian Tribe entities, including political
subdivisions thereof, may establish organizational units that may act
as accreditation bodies, provided such units meet the requirements of
this section, are approved by the Secretary under this section, and
have taken appropriate measures to prevent actual or apparent conflicts
of interest, including cases in which State or Federal funds are used
to support MOUD.
Sec. 8.4 Accreditation body responsibilities.
(a) Accreditation surveys and for cause inspections. (1)
Accreditation bodies shall conduct routine accreditation surveys for
initial accreditation, and then at least every three years to allow for
renewal of certification.
(2) Accreditation bodies must agree to conduct for-cause
inspections upon the request of the Secretary.
(3) Accreditation decisions shall be fully consistent with the
policies and procedures submitted as part of the approved accreditation
body application.
(b) Response to noncompliant programs. (1) If an accreditation body
receives or discovers information that suggests that an OTP is not
meeting applicable accreditation or certification standards established
or authorized under this part, or if a survey of the OTP by the
accreditation body demonstrates that such standards are not being met,
the accreditation body shall either require and monitor corrective
action or shall suspend or revoke accreditation of the OTP, as
appropriate based on the significance of the deficiencies.
(i) Accreditation bodies shall either not accredit or shall revoke
the accreditation of any OTP that substantially fails to meet the
Federal Opioid Use Disorder treatment standards.
(ii) Accreditation bodies shall notify the Secretary as soon as
possible but in no case longer than 48 hours after becoming aware of
any practice or condition in an OTP that may pose a serious risk to
public health or safety or patient care.
(iii) If an accreditation body determines that an OTP is meeting
the Federal Opioid Use Disorder treatment standards, as defined in
Sec. 8.12, but is not meeting one or more accreditation elements
within 60 days of survey completion, the accreditation body shall
determine the necessary corrective measures to be taken by the OTP,
establish a schedule for implementation of such measures not to exceed
60 days, and notify the OTP in writing that it must implement such
measures within the specified schedule in order to ensure continued
accreditation. The accreditation body shall verify that the necessary
corrective measures are implemented by the OTP within the schedule
specified and that all accreditation elements are met within the
specified schedule. Within 60 days after the specified schedule for
implementation, the accreditation body will notify the Secretary, in
writing, whether or not the OTP has completed the corrective measures.
(2) Nothing in this part shall prevent accreditation bodies from
granting accreditation, contingent on the implementation of
programmatic or performance changes, to OTPs with less substantial
violations. Less substantial violations refers to non-conformance with
accreditation standards that do not involve immediate, high-risk health
and safety concerns. Such accreditation shall not exceed 12 months
during which time a resurvey or reinspection must occur to determine
whether the applicable changes have been implemented. OTPs that have
been granted such accreditation must have their accreditation revoked
if they fail to implement the applicable changes upon resurvey or
reinspection.
(c) Recordkeeping. (1) Accreditation bodies shall maintain, and
make available as requested by the Secretary, records of their
accreditation activities for at least 5 years from the creation of the
record. Such records must contain sufficient detail to support each
accreditation decision made by the accreditation body.
(2) Accreditation bodies shall establish procedures to protect
confidential information collected or received in their role as
accreditation bodies that are consistent with, and that are designed to
ensure compliance with, all Federal and State laws, including 42 CFR
part 2.
(i) Information collected or received for the purpose of carrying
out accreditation body responsibilities shall not be used for any other
purpose or disclosed, other than to the Secretary or its duly
designated representatives, unless otherwise required by law or with
the consent of the OTP.
(ii) Nonpublic information that the Secretary shares with the
accreditation body concerning an OTP shall not be further disclosed
except with the written permission of the Secretary.
(d) Reporting. (1) Accreditation bodies shall provide to the
Secretary any
[[Page 77354]]
documents and information requested by the Secretary within 5 days of
receipt of the request.
(2) Accreditation bodies shall submit a summary of the results of
each accreditation survey to the Secretary within 90 days following the
survey visit. Such summaries shall contain sufficient detail to justify
the accreditation action taken.
(3) Accreditation bodies shall provide the Secretary a list of each
OTP surveyed, and the identity of all individuals involved in the
conducting and reporting of survey results.
(4) Accreditation bodies shall submit to the Secretary the name of
each OTP for which the accreditation body accredits conditionally,
denies, suspends, or revokes accreditation, and the basis for the
action, within 48 hours of the action.
(5) Notwithstanding any reports made to the Secretary under
paragraphs (d)(1) through (4) of this section, each accreditation body
shall submit to the Secretary semiannually, on January 15 and July 15
of each calendar year, a report consisting of a summary of the results
of each accreditation survey conducted in the past year. The summary
shall contain sufficient detail to justify each accreditation action
taken.
(6) All reporting requirements listed in this section shall be
provided to the Secretary at the address specified in Sec. 8.3(b).
(e) Complaint response. Accreditation bodies shall have policies
and procedures in place to respond to complaints received from the
Secretary, patients, facility staff, and others within 5 business days
from the receipt of the complaint. Accreditation bodies shall also
agree to notify the Secretary within 5 business days of receipt of a
complaint from a patient, facility, staff or others, and to inform the
Secretary of their response to the complaint.
(f) Modifications of accreditation elements. Accreditation bodies
shall obtain the Secretary's written authorization prior to making any
substantive (i.e., noneditorial) change in accreditation elements.
(g) Conflicts of interest. The accreditation body shall maintain
and apply policies and procedures that the Secretary has approved in
accordance with Sec. 8.3 to reduce the possibility of actual conflict
of interest, or the appearance of a conflict of interest, on the part
of individuals who act on behalf of the accreditation body. Individuals
who participate in accreditation surveys or otherwise participate in
the accreditation decision or an appeal of the accreditation decision,
as well as their spouses and minor children, shall not have a financial
interest in the OTP that is the subject of the accreditation survey or
decision.
(h) Accreditation teams. (1) An accreditation body survey team
shall consist of healthcare professionals with expertise in OUD
treatment. The accreditation body shall consider factors such as the
size of the OTP, the anticipated number of survey non-compliance
issues, and the OTP's accreditation history in determining the
composition of the team. At a minimum, survey teams shall consist of at
least two healthcare professionals whose combined expertise includes:
(i) The dispensing and administration of medications subject to
control under the Controlled Substances Act (21 U.S.C. 801 et seq.);
(ii) Medical issues relating to the dosing and administration of
MOUD for the treatment of OUD;
(iii) Psychosocial counseling of individuals receiving OUD
treatment; and
(iv) Organizational and administrative issues associated with OTPs.
(2) Members of the accreditation team must be able to recuse
themselves at any time from any survey in which either they or the OTP
believes there is an actual conflict of interest or the appearance of a
conflict of interest. Conflict or perceived conflict of interest must
be documented by the accreditation body and made available to the
Secretary.
(i) Accreditation fees. Fees charged to OTPs for accreditation
shall be reasonable. the Secretary generally will find fees to be
reasonable if the fees are limited to recovering costs to the
accreditation body, including overhead incurred. Accreditation body
activities that are not related to accreditation functions are not
recoverable through fees established for accreditation.
(1) The accreditation body shall make public its fee structure,
including those factors, if any, contributing to variations in fees for
different OTPs.
(2) At the Secretary's request, accreditation bodies shall provide
to the Secretary financial records or other materials, in a manner
specified by the Secretary, to assist in assessing the reasonableness
of accreditation body fees.
Sec. 8.5 Periodic evaluation of accreditation bodies.
The Secretary will periodically evaluate the performance of
accreditation bodies primarily by inspecting a selected sample of the
OTPs accredited by the accrediting body, and by evaluating the
accreditation body's reports of surveys conducted, to determine whether
the OTPs surveyed and accredited by the accreditation body are in
compliance with applicable standards under this part. The evaluation
will include a determination of whether there are major deficiencies in
the accreditation body's performance that, if not corrected, would
warrant withdrawal of the approval of the accreditation body under
Sec. 8.6.
Sec. 8.6 Withdrawal of approval of accreditation bodies.
If the Secretary determines that an accreditation body is not in
substantial compliance with this subpart, the Secretary shall take
appropriate action as follows:
(a) Major deficiencies. If the Secretary determines that the
accreditation body has a major deficiency, such as commission of fraud,
material false statement, failure to perform a major accreditation
function satisfactorily, or significant noncompliance with the
requirements of this subpart, the Secretary shall withdraw approval of
that accreditation body.
(1) In the event of a major deficiency, the Secretary shall notify
the accreditation body of the agency's action and the grounds on which
the approval was withdrawn.
(2) An accreditation body that has lost its approval shall notify
each OTP that has been accredited or is seeking accreditation that the
accreditation body's approval has been withdrawn. Such notification
shall be made within a time period and in a manner approved by the
Secretary.
(b) Minor deficiencies. If the Secretary determines that the
accreditation body has minor deficiencies in the performance of an
accreditation function, that are less serious or more limited than the
types of deficiencies described in paragraph (a) of this section, the
Secretary will notify the body that it has 90 days to submit to the
Secretary a plan of corrective action. The plan must include a summary
of corrective actions and a schedule for their implementation. The
Secretary may place the body on probationary status for a period of
time determined by the Secretary, or may withdraw approval of the body
if corrective action is not taken.
(1) If the Secretary places an accreditation body on probationary
status, the body shall notify all OTPs that have been accredited, or
that are seeking accreditation, of the accreditation body's
probationary status
[[Page 77355]]
within a time period and in a manner approved by the Secretary.
(2) Probationary status will remain in effect until such time as
the body can demonstrate to the satisfaction of the Secretary that it
has successfully implemented or is implementing the corrective action
plan within the established schedule, and the corrective actions taken
have substantially eliminated all identified problems.
(3) If the Secretary determines that an accreditation body that has
been placed on probationary status is not implementing corrective
actions satisfactorily or within the established schedule, the
Secretary may withdraw approval of the accreditation body. The
accreditation body shall notify all OTPs that have been accredited, or
are seeking accreditation, of the accreditation body's loss of the
Secretary's approval within a time period and in a manner approved by
the Secretary.
(c) Reapplication. (1) An accreditation body that has had its
approval withdrawn may submit a new application for approval if the
body can provide information to the Secretary to establish that the
problems that were grounds for withdrawal of approval have been
resolved.
(2) If the Secretary determines that the new application
demonstrates that the body satisfactorily has addressed the causes of
its previous unacceptable performance, the Secretary may reinstate
approval of the accreditation body.
(3) The Secretary may request additional information or establish
additional conditions that must be met before the Secretary approves
the reapplication.
(4) The Secretary may refuse to accept an application from a former
accreditation body whose approval was withdrawn because of fraud,
material false statement, or willful disregard of public health.
(d) Hearings. An opportunity to challenge an adverse action taken
regarding withdrawal of approval of an accreditation body shall be
addressed through the relevant procedures set forth in subpart C of
this part, except that the procedures in Sec. 8.28 for expedited
review of an immediate suspension would not apply to an accreditation
body that has been notified under paragraph (a) or (b) of this section
of the withdrawal of its approval.
Subpart C--Certification and Treatment Standards for Opioid
Treatment Programs
Sec. 8.11 Opioid Treatment Program certification.
(a) General. (1) An OTP must be the subject of a current, valid
certification from the Secretary to be considered qualified by the
Secretary under section 303(g)(1) of the Controlled Substances Act (21
U.S.C. 823(g)(1)) to dispense MOUD in the treatment of OUD. An OTP must
be determined to be qualified under section 303(g)(1) of the Controlled
Substances Act, and must be determined to be qualified by the Attorney
General under section 303(g)(1), to be registered by the Attorney
General to dispense MOUD to individuals for treatment of OUD.
(2) To obtain certification from the Secretary, an OTP must meet
the Federal Opioid Use Disorder treatment standards in Sec. 8.12, must
be the subject of a current, valid accreditation by an accreditation
body or other entity designated by the Secretary, and must comply with
any other conditions for certification established by the Secretary.
(3) OTPs are expected to maintain certification with the Secretary
and to comply with any other conditions for certification established
by the Secretary. Certification shall be granted for a term not to
exceed 3 years, except that certification may be renewed during the
final certification year if the OTP applies for certification renewal
in accordance with the steps outlined in paragraph (a)(4) of this
section.
(4) OTPs who satisfy the criteria for certification under this
section may apply for renewal of their certification. OTPs are expected
to apply for certification renewal during the final year of the OTP's
certification period. OTPs should take steps to ensure that
administrative tasks associated with renewal are completed before the
OTP's certification expires. OTPs may apply for certification renewal
in accordance with the procedures as outlined in paragraph (b) of this
section. If an OTP anticipates any delays in routine certification
renewal, an extension may be requested by submitting to the Secretary a
statement justifying the extension in accordance with paragraph (e) of
this section.
(5) OTPs that are certified and are seeking certification renewal,
and who have been granted accreditation for one year by an
accreditation body as provided under Sec. 8.4(b)(1)(iii), may receive
a conditional certification for 1 year unless the Secretary determines
that such conditional certification would adversely affect patient
health. An OTP must obtain a standard 3-year accreditation, as
described in paragraph (a)(3) of this section, within the 1-year
conditional certification period. If standard accreditation is not
obtained by the OTP within the 1-year conditional certification period,
the OTP's conditional certification will lapse, and the Attorney
General will be notified that the OTP's registration should be revoked.
(6) OTPs whose certification has expired, and who seek re-
certification, will be considered ``new'' programs and will be required
to apply for provisional certification in accordance with paragraph (d)
of this section.
(b) Application for initial or renewal certifications and re-
certification. Applications for certification must be submitted by the
OTP using form SMA-162. The application for initial or renewal of
certification shall include, as determined by the Secretary:
(1) A description of the current accreditation status of the OTP;
(2) A description of the organizational structure of the OTP;
(3) The names of the persons responsible for the OTP;
(4) The addresses of the OTP and of each medication unit or other
facility under the of the OTP;
(5) The sources of funding for the OTP and the name and address of
each governmental entity that provides such funding;
(6) A statement that the OTP will comply with the conditions of
certification set forth in paragraph (g) of this section; and
(7) The application shall be signed by the program sponsor who
shall certify that the information submitted in the application is
truthful and accurate.
(8) Applications for re-certification shall include an explanation
of why the OTP's most recent certification expired and information
regarding the schedule for an accreditation survey.
(c) Action on application. (1) Following the Secretary's receipt of
an application for certification of an OTP, and after consultation with
the appropriate State authority regarding the qualifications of the
applicant, the Secretary may grant the application for certification,
or renew an existing certification, if the Secretary determines that
the OTP has satisfied the requirements for certification or renewal of
certification in this section.
(2) The Secretary may deny the application if the Secretary
determines that:
(i) The application for certification is deficient in any respect;
[[Page 77356]]
(ii) The OTP will not be operated in accordance with the Federal
Opioid Use Disorder treatment standards established under Sec. 8.12;
(iii) The OTP will not permit an inspection or a survey to proceed,
or will not permit in a timely manner access to relevant records or
information; or
(iv) The OTP has made misrepresentations in obtaining accreditation
or in applying for certification.
(3) Within 5 days after it reaches a final determination that an
OTP meets the requirements for certification in this section, the
Secretary will notify the Drug Enforcement Administration (DEA) that
the OTP has been determined to be qualified to provide OUD treatment
under section 303(g)(1) of the Controlled Substances Act.
(d) Provisional certification. New OTPs that have not received the
Secretary's certification previously, except as provided in paragraph
(a)(6) of this section, who are applying for certification from the
Secretary, and who have applied for accreditation with an accreditation
body, are eligible to receive provisional certification for up to 1
year. To receive provisional certification, an OTP shall submit the
information required by paragraph (b) of this section to the Secretary
along with a statement identifying the accreditation body to which the
OTP has applied for accreditation, the date on which the OTP applied
for accreditation, the dates of any accreditation surveys that have
taken place or are expected to take place, and the expected schedule
for completing the accreditation process. Provisional certification for
up to 1 year will be granted, following receipt of the information
described in this paragraph (d), unless the Secretary determines that
patient health would be adversely affected by the granting of
provisional certification.
(e) Requirements for certification. (1) OTPs shall comply with all
pertinent State laws and regulations. Nothing in this part is intended
to limit the authority of State and, as appropriate, local governmental
entities to regulate the use of MOUD in the treatment of OUD. The
provisions of this section requiring compliance with requirements
imposed by State law, or the submission of applications or reports
required by the State authority, do not apply to OTPs operated directly
by the Department of Veterans Affairs, the Indian Health Service, or
any other department or agency of the United States. Federal agencies
operating OTPs have agreed to cooperate voluntarily with State agencies
by granting permission on an informal basis for designated State
representatives to visit Federal OTPs and by furnishing a copy of
Federal reports to the State authority, including the reports required
under this section.
(2) OTPs shall allow, in accordance with Federal controlled
substances laws and Federal confidentiality laws, inspections and
surveys by duly authorized employees of the Department of Health and
Human Services or Substance Abuse and Mental Health Services
Administration (SAMHSA), by accreditation bodies, by the DEA, and by
authorized employees of any relevant State or Federal governmental
authority.
(3) Disclosure of patient records maintained by an OTP is governed
by the provisions of 42 CFR part 2 and 45 CFR parts 160 and 164, and
every program must comply with these regulations, as applicable.
Records on the receipt, storage, and distribution of MOUD are also
subject to inspection under Federal controlled substances laws and
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.).
Federally sponsored treatment programs are subject to applicable
Federal confidentiality statutes.
(4) A treatment program or medication unit or any part thereof,
including any facility or any individual, shall permit a duly
authorized employee of the Department of Health and Human Services or
SAMHSA to have access to and to copy all records on the use of MOUD in
accordance with the provisions of 42 CFR part 2.
(5) OTPs shall notify the Secretary in writing within 3 weeks of
any replacement or other change in the status of the program sponsor or
medical director.
(6) OTPs shall comply with all regulations enforced by the DEA
under 21 CFR chapter II, and must be registered by the DEA before
administering or dispensing MOUD.
(7) OTPs must operate in accordance with Federal Opioid Use
Disorder treatment standards and approved accreditation elements.
(f) Conditions for interim treatment program approval. (1) Before a
public or nonprofit private OTP may provide interim treatment, the
program must receive the approval of both the Secretary and the SOTA of
the State in which the OTP operates.
(2) Before the Secretary may grant such approval, the OTP must
provide the Secretary with documentation from the SOTA of the State in
which the OTP operates demonstrating that:
(i) Such officer does not object to the providing of interim
treatment in the State;
(ii) The OTP seeking to provide such treatment is unable to provide
access for patients in a public or nonprofit private comprehensive
treatment program within a reasonable geographic area within 14 days of
the time patients seek treatment for OUD;
(iii) The authorization of the OTP to provide interim treatment
will not otherwise reduce the capacity of comprehensive treatment
programs in the State to admit individuals (relative to the date on
which such officer so certifies); and
(iv) OTPs providing interim treatment will arrange for each
individual's transfer to a comprehensive treatment program no later
than 180 days from the date on which each individual first requested
treatment. Individuals enrolled in interim treatment shall not be
discharged without the approval of an OTP practitioner, which is to be
documented in the patient record, while awaiting transfer to a
comprehensive treatment program.
(3) The Secretary will provide notice to the OTP denying or
approving the request to provide interim treatment. The OTP shall not
provide such treatment until it has received such notice from the
Secretary.
(g) Exemptions. An OTP may, at the time of application for
certification or any time thereafter, request from the Secretary
exemption from the regulatory requirements set forth under this section
and Sec. 8.12. An example of a case in which an exemption might be
granted would be for a private practitioner who wishes to treat a
limited number of patients in a non-metropolitan area with few
physicians and no OUD treatment services geographically accessible, and
requests exemption from some of the staffing and service standards. The
OTP shall support the rationale for the exemption with thorough
documentation, to be supplied in an appendix to the initial application
for certification or in a separate submission. The Secretary will
approve or deny such exemptions at the time of application, or any time
thereafter, if appropriate. The Secretary shall consult with the
appropriate State authority prior to taking action on an exemption
request.
(h) Medication units, long-term care facilities and hospitals. (1)
Certified OTPs may establish medication units that are authorized to
dispense MOUD. Before establishing a medication unit, a certified OTP
must notify the Secretary by submitting form SMA-162. The OTP must also
comply with the provisions of 21 CFR part 1300 before establishing a
medication unit. Medication units shall comply with all pertinent State
laws and regulations.
[[Page 77357]]
(2) Specifically, any services that are provided in an OTP may be
provided in the medication unit, assuming compliance with all
applicable Federal, State, and local law, and the use of units that
provide appropriate privacy and have adequate space.
(3) Certification as an OTP under this part will not be required
for the continuous medication treatment or withdrawal management of a
patient who is admitted to a hospital or long-term care facility for
the treatment of medical conditions other than OUD and who requires
medication continuity or withdrawal management during the period of
their stay in that long-term care facility when such treatment is
permitted under applicable Federal law. The term ``long-term care
facility'' is defined in Sec. 8.2. Nothing in this section is intended
to relieve long-term care facilities from the obligation to obtain
registration from the Attorney General, as appropriate, under section
303(g) of the Controlled Substances Act.
Sec. 8.12 Federal Opioid Use Disorder treatment standards.
(a) General. OTPs must provide treatment in accordance with the
standards in this section and must comply with these standards as a
condition of certification.
(b) Administrative and organizational structure. (1) An OTP's
organizational structure and facilities shall be adequate to ensure
quality patient care and to meet the requirements of all pertinent
Federal, State, and local laws and regulations. At a minimum, each OTP
shall formally designate a program sponsor and medical director. The
program sponsor shall agree on behalf of the OTP to adhere to all
requirements set forth in this part.
(2) The medical director shall assume responsibility for all
medical and behavioral health services performed by the OTP. In
addition, the medical director shall be responsible for ensuring that
the OTP is in compliance with all applicable Federal, State, and local
laws and regulations.
(c) Continuous quality improvement. (1) An OTP must maintain
current quality assurance and quality control plans that include, among
other things, annual reviews of program policies and procedures and
ongoing assessment of patient outcomes.
(2) An OTP must maintain a current ``Diversion Control Plan'' or
``DCP'' as part of its quality assurance program that contains specific
measures to reduce the possibility of diversion of dispensed MOUD, and
that assigns specific responsibility to the OTP providers and
administrative staff for carrying out the diversion control measures
and functions described in the DCP.
(d) Staff credentials. Each person engaged in the treatment of OUD
must have sufficient education, training, and experience, or any
combination thereof, to enable that person to perform the assigned
functions. All qualifying practitioners and other licensed/certified
health care providers, including counselors, must comply with the
credentialing and maintenance of licensure and/or certification
requirements of their respective professions.
(e) Patient admission criteria--(1) Comprehensive treatment. An OTP
shall maintain current procedures designed to ensure that patients are
admitted to treatment by qualified personnel who have determined, using
accepted medical criteria, that: The person meets diagnostic criteria
for a moderate to severe OUD; the individual has an active moderate to
severe OUD, or OUD in remission, or is at high risk for recurrence or
overdose. Such decisions must be appropriately documented in the
patient's clinical record. In addition, a qualifying health care
practitioner shall ensure that each patient voluntarily chooses
treatment with MOUD and that all relevant facts concerning the use of
MOUD are clearly and adequately explained to the patient, and that each
patient provides informed consent to treatment.
(2) Comprehensive treatment for persons under age 18. Except in
States where State law grants persons under 18 years of age the ability
to consent to OTP treatment without the consent of another, no person
under 18 years of age may be admitted to OTP treatment unless a parent,
legal guardian, or responsible adult designated by the relevant State
authority consents in writing to such treatment.
(3) Withdrawal management. An OTP shall maintain current procedures
that are designed to ensure that those patients who choose to taper
from MOUD are provided the opportunity to do so with informed consent
and at a mutually agreed-upon rate that minimizes taper-related risks.
Such consent must be documented in the clinical record by the treating
practitioner.
(f) Required services--(1) General. OTPs shall provide adequate
medical, counseling, vocational, educational, and other screening,
assessment, and treatment services to meet patient needs, with the
combination and frequency of services tailored to each individual
patient based on an individualized assessment and the patient's care
plan that was created after shared decision making between the patient
and the clinical team. These services must be available at the primary
facility, except where the program sponsor has entered into a
documented agreement with a private or public agency, organization,
practitioner, or institution to provide these services to patients
enrolled in the OTP. The program sponsor, in any event, must be able to
document that these services are fully and reasonably available to
patients.
(2) Initial medical examination. (i) OTPs shall require each
patient to undergo an initial medical examination. The initial medical
examination is comprised of two parts:
(A) A screening examination to ensure that the patient meets
criteria for admission and that there are no contraindications to
treatment with MOUD; and
(B) A full history and examination, to determine the patient's
broader health status, with lab testing.
(ii) Assuming no contraindications, a patient may commence
treatment with MOUD after the screening examination has been completed.
Both the screening examination and full examination must be completed
by an appropriately licensed practitioner. If the licensed practitioner
is not an OTP practitioner, the screening examination must be completed
no more than seven days prior to OTP admission. Where the examination
is performed outside of the OTP, the written results and narrative of
the examination, as well as available lab testing results, must be
transmitted, consistent with applicable privacy laws, to the OTP, and
verified by an OTP practitioner.
(iii) A full in person physical examination, including the results
of serology and other tests, such as a pregnancy test, must be
completed within 14 calendar days following a patient's admission to
the OTP. The full exam can be completed by a non-OTP practitioner, if
the exam is verified by a licensed OTP practitioner as being true and
accurate and transmitted in accordance with applicable privacy laws.
(iv) Serology testing and other testing as deemed medically
appropriate by the licensed OTP practitioner based on the screening or
full history and examination, drawn not more than 30 days prior to
admission to the OTP, may form part of the full history and
examination.
(v) The screening and full examination may be completed via
telehealth for those patients being admitted for treatment with either
[[Page 77358]]
buprenorphine or methadone, if a qualified practitioner or primary care
provider, determines that an adequate evaluation of the patient can be
accomplished via telehealth. When using telehealth, the following
caveats apply:
(A) In evaluating patients for treatment with schedule II
medications (such as Methadone), audio-visual telehealth platforms must
be used, except when not available to the patient. When not available,
it is acceptable to use audio-only devices, but only when the patient
is in the presence of a licensed practitioner who is registered to
prescribe (including dispense) controlled medications.
(B) In evaluating patients for treatment with schedule III
medications (such as Buprenorphine) or medications not classified as a
controlled medication (such as Naltrexone), audio-visual or audio only
platforms may be used.
(3) Special services for pregnant patients. OTPs must maintain
current policies and procedures that reflect the special needs and
priority for treatment admission of patients with OUD who are pregnant.
Pregnancy should be confirmed. Evidence-based treatment protocols for
the pregnant patient, such as split dosing regimens, may be instituted
after assessment by an OTP practitioner and documentation that confirms
the clinical appropriateness of such an evidence-based treatment
protocol. Prenatal care and other sex specific services, including
reproductive health services, for pregnant and postpartum patients must
be provided and documented either by the OTP or by referral to
appropriate healthcare practitioners. Specific services, including
reproductive health services, for pregnant and postpartum patients must
be provided and documented either by the OTP or by referral to
appropriate healthcare practitioners.
(4) Initial and periodic physical and behavioral health assessment
services. (i) Each patient admitted to an OTP shall be given a physical
and behavioral health assessment, which includes but is not limited to
screening for imminent risk of harm to self or others, within 14
calendar days following admission, and periodically by appropriately
licensed/credentialed personnel. These assessments must address the
need for and/or response to treatment, adjust treatment interventions,
including MOUD, as necessary, and provide a patient-centered plan of
care. The full, initial psychosocial assessment must be completed
within 14 calendar days of admission and include preparation of a care
plan that includes the patient's goals and mutually agreed-upon actions
for the patient to meet those goals, including harm reduction
interventions; the patient's needs and goals in the areas of education,
vocational training, and employment; and the medical and psychiatric,
psychosocial, economic, legal, housing, and other recovery support
services that a patient needs and wishes to pursue. The care plan also
must identify the recommended frequency with which services are to be
provided. The plan must be reviewed and updated to reflect responses to
treatment and recovery support services, and adjustments made that
reflect changes in the context of the person's life, their current
needs for and interests in medical, psychiatric, social, and
psychological services, and current needs for and interests in
education, vocational training, and employment services.
(ii) The periodic physical examination should occur not less than
one time each year and be conducted by an OTP practitioner. The
periodic physical examination should include review of MOUD dosing,
treatment response, other substance use disorder treatment needs,
responses and patient-identified goals, and other relevant physical and
psychiatric treatment needs and goals. The periodic physical
examination should be documented in the patient's clinical record.
(5) Counseling and psychoeducational services. (i) OTPs must
provide adequate substance use disorder counseling and psychoeducation
to each patient as clinically necessary and mutually agreed-upon,
including harm reduction education and recovery-oriented counseling.
This counseling shall be provided by a program counselor, qualified by
education, training, or experience to assess the psychological and
sociological background of patients, and engage with patients, to
contribute to the appropriate care plan for the patient and to monitor
and update patient progress. Patient refusal of counseling shall not
preclude them from receiving MOUD.
(ii) OTPs must provide counseling on preventing exposure to, and
the transmission of, human immunodeficiency virus (HIV), viral
hepatitis, and sexually transmitted infections (STIs) and either
directly provide services and treatments or actively link to treatment
each patient admitted or readmitted to treatment who has received
positive test results for these conditions from initial and/or periodic
medical examinations.
(iii) OTPs must provide directly, or through referral to adequate
and reasonably accessible community resources, vocational training,
education, and employment services for patients who request such
services or for whom these needs have been identified and mutually
agreed-upon as beneficial by the patient and program staff.
(6) Drug testing services. OTPs must provide drug tests that have
received the Food and Drug Administration's (FDA) marketing
authorization for commonly used and misused substances that may impact
patient safety, recovery, or otherwise complicate substance use
disorder treatment, at a frequency that is in accordance with generally
accepted clinical practice and as indicated by a patient's response to
and stability in treatment, but no fewer than eight random drug tests
per year patient, allowing for extenuating circumstances at the
individual patient level.
(g) Recordkeeping and patient confidentiality. (1) OTPs shall
establish and maintain a recordkeeping system that is adequate to
document and monitor patient care. This system is required to comply
with all Federal and State reporting requirements relevant to MOUD
approved for use in treatment of OUD. All records are required to be
kept confidential in accordance with all applicable Federal and State
requirements.
(2) OTPs shall include, as an essential part of the recordkeeping
system, documentation in each patient's record that the OTP made a good
faith effort to determine whether the patient is enrolled in any other
OTP. A patient enrolled in an OTP shall not be permitted to obtain
treatment in any other OTP except in circumstances involving an
inability to access care at the patient's OTP of record. Such
circumstances include, but are not limited to, travel for work or
family events, temporary relocation, or an OTP's temporary closure. If
the medical director or program practitioner of the OTP in which the
patient is enrolled determines that such circumstances exist, the
patient may seek treatment at another OTP, provided the justification
for the particular circumstances are noted in the patient's record both
at the OTP in which the patient is enrolled and at the OTP that will
provide the MOUD.
(h) Medication administration, dispensing, and use. (1) OTPs must
ensure that MOUD are administered or dispensed only by a practitioner
licensed under the appropriate State law and registered under the
appropriate State and Federal laws to administer or dispense MOUD, or
by an agent of such a practitioner, supervised by and under the order
of the licensed practitioner
[[Page 77359]]
and if consistent with Federal and State law.
(2) OTPs shall use only those MOUD that are approved by the Food
and Drug Administration under section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) for use in the treatment of OUD. In
addition, OTPs who are fully compliant with the protocol of an
investigational use of a drug and other conditions set forth in the
application may administer a drug that has been authorized by the Food
and Drug Administration under an investigational new drug application
under section 505(i) of the Federal Food, Drug, and Cosmetic Act for
investigational use in the treatment of OUD. Currently the following
MOUD will be considered to be approved by the Food and Drug
Administration for use in the treatment of OUD:
(i) Methadone;
(ii) Buprenorphine and buprenorphine combination products that have
been approved for use in the treatment of OUD; and
(iii) Naltrexone.
(3) OTPs shall maintain current procedures that are adequate to
ensure that the following dosage form and initial dosing requirements
are met:
(i) Methadone shall be administered or dispensed only in oral form
and shall be formulated in such a way as to reduce its potential for
parenteral misuse.
(ii) For each new patient enrolled in a program, the initial dose
of methadone shall be individually determined, and is not to exceed 30
milligrams, and the total dose for the first day shall not exceed 40
milligrams. Should this not be sufficient to suppress symptoms of
withdrawal, the OTP practitioner licensed under the appropriate State
law and registered under the appropriate State and Federal laws to
administer or dispense MOUD, must document in the patient's record a
specific rationale indicating that 40 milligrams did not adequately
suppress opioid withdrawal symptoms, and that a higher dose was
clinically indicated and thus provided to the patient.
(4) OTPs shall maintain current procedures adequate to ensure that
each MOUD used by the program is administered and dispensed in
accordance with its FDA approved product labeling. The program must
ensure that any significant deviations from the approved labeling,
including deviations with regard to dose, frequency, or the conditions
of use described in the approved labeling, are specifically documented
in the patient's record.
(i) Unsupervised or ``take home'' medication doses. Unsupervised or
``take home'' medication doses may be provided under the following
circumstances:
(1) Any patient in comprehensive treatment may receive their
individualized take home doses as ordered for days that the clinic is
closed for business, including one weekend day (e.g., Sunday) and State
and Federal holidays, no matter their length of time in treatment.
(2) Treatment program decisions on dispensing MOUD to patients for
unsupervised use beyond that set forth in paragraph (i)(1) of this
section shall be determined by an appropriately licensed OTP medical
practitioner or the medical director. In determining which patients may
receive unsupervised medication doses, the medical director or program
medical practitioner shall consider, among other pertinent factors that
indicate that the therapeutic benefits of unsupervised doses outweigh
the risks, the following criteria:
(i) Absence of active substance use disorders, other physical or
behavioral health conditions that increase the risk of patient harm as
it relates to the potential for overdose, or the ability to function
safely;
(ii) Regularity of attendance for supervised medication
administration;
(iii) Absence of serious behavioral problems that endanger the
patient, the public or others;
(iv) Absence of known recent diversion activity;
(v) Whether take home medication can be safely transported and
stored; and
(vi) Any other criteria that the medical director or medical
practitioner considers relevant to the patient's safety and the
public's health.
(3) Such determinations and the basis for such determinations
consistent with the criteria outlined in paragraph (i)(2) of this
section shall be documented in the patient's medical record. If it is
determined that a patient is safely able to manage unsupervised doses
of MOUD, the dispensing restrictions set forth in paragraphs (i)(3)(i)
through (iii) of this section apply. The dispensing restrictions set
forth in paragraphs (i)(3)(i) through (iii) of this section do not
apply to buprenorphine and buprenorphine products listed under
paragraph (h)(2)(ii) of this section.
(i) During the first 14 days of treatment, the take home supply
(beyond that of paragraph (i)(1) of this section) is limited to 7 days.
It remains within the OTP practitioner's discretion to determine the
number of take home doses up to 7 days, but decisions must be based on
the criteria listed in paragraph (i)(2) of this section. The rationale
underlying the decision to provide unsupervised doses of methadone must
be documented in the patient's clinical record, consistent with
paragraph (g)(2) of this section.
(ii) From 15 days of treatment, the take home supply (beyond that
of paragraph (i)(1) of this section) is limited to 14 days. It remains
within the OTP practitioner's discretion to determine the number of
take home doses up to 14 days, but this determination must be based on
the criteria listed in paragraph (i)(2) of this section. The rationale
underlying the decision to provide unsupervised doses of methadone must
be documented in the patient's clinical record, consistent with
paragraph (g)(2) of this section.
(iii) From 31 days of treatment, the take home supply (beyond that
of paragraph (i)(1) of this section) provided to a patient is not to
exceed 28 days. It remains within the OTP practitioner's discretion to
determine the number of take home doses up to 28 days, but this
determination must be based on the criteria listed in paragraph (i)(2)
of this section. The rationale underlying the decision to provide
unsupervised doses of methadone must be documented in the patient's
clinical record, consistent with paragraph (g)(2) of this section.
(4) OTPs must maintain current procedures adequate to identify the
theft or diversion of take home medications, including labeling
containers with the OTP's name, address, and telephone number. Programs
also must ensure that each individual take home dose is packaged in a
manner that is designed to reduce the risk of accidental ingestion,
including child-proof containers (see Poison Prevention Packaging Act,
Pub. L. 91-601 (15 U.S.C. 1471 et seq.)). Programs must provide
education to each patient on: Safely transporting medication from the
OTP to their place of residence; and the safe storage of take home
doses at the individual's place of residence, including child and
household safety precautions. The provision of this education should be
documented in the patient's clinical record.
(j) Interim treatment. (1) The program sponsor of a public or
nonprofit, private OTP may admit an individual, who is eligible for
admission to comprehensive treatment, into interim treatment if
comprehensive services are not readily available within a reasonable
geographic area and within 14 days of the individual's seeking
treatment. At least two drug tests shall be obtained from patients
during the maximum of 180
[[Page 77360]]
days permitted for interim treatment. A program shall establish and
follow reasonable criteria for establishing priorities for moving
patients from interim to comprehensive treatment. These transition
criteria shall be in writing and shall include, at a minimum,
prioritization of pregnant patients in admitting patients to interim
treatment and from interim to comprehensive treatment. Interim
treatment shall be provided in a manner consistent with all applicable
Federal and State laws, including sections 1923, 1927(a), and 1976 of
the Public Health Service Act (21 U.S.C. 300x-23, 300x-27(a), and 300y-
11).
(2) The program shall notify the SOTA when a patient begins interim
treatment, when a patient leaves interim treatment, and before the date
of transfer to comprehensive services, and shall document such
notifications.
(3) The Secretary may revoke the interim authorization for programs
that fail to comply with the provisions of this paragraph (j).
Likewise, the Secretary will consider revoking the interim
authorization of a program if the State in which the program operates
is not in compliance with the provisions of Sec. 8.11(h).
(4) All requirements for comprehensive treatment in this section
apply to interim treatment with the following exceptions:
(i) A primary counselor is not required to be assigned to the
patient, but crisis services should be available;
(ii) Interim treatment cannot be provided for longer than 180 days
in any 12-month period;
(iii) By day 120, a plan for continuing treatment beyond 180 days
must be created, and documented in the patient's clinical record; and
(iv) Formal counseling, vocational training, employment, and
educational services described in paragraphs (f)(4) and (f)(5)(i) and
(iii) of this section are not required to be offered to the patient.
However, information pertaining to locally available, community-based
resources for ancillary services should be made available to individual
patients in interim treatment.
Sec. 8.13 Revocation of accreditation and accreditation body
approval.
(a) The Secretary's action following revocation of accreditation.
If an accreditation body revokes an OTP's accreditation, the Secretary
may conduct an investigation into the reasons for the revocation.
Following such investigation, the Secretary may determine that the
OTP's certification should no longer be in effect, at which time the
Secretary will initiate procedures to revoke the program's
certification in accordance with Sec. 8.14. Alternatively, the
Secretary may determine that another action or combination of actions
would better serve the public health, including the establishment and
implementation of a corrective plan of action that will permit the
certification to continue in effect while the OTP seeks
reaccreditation.
(b) Accreditation body approval. (1) If the Secretary withdraws the
approval of an accreditation body under Sec. 8.6, the certifications
of OTPs accredited by such body shall remain in effect for a period of
1 year after the date of withdrawal of approval of the accreditation
body, unless the Secretary determines that to protect public health or
safety, or because the accreditation body fraudulently accredited
treatment programs, the certifications of some or all of the programs
should be revoked or suspended or that a shorter time period should be
established for the certifications to remain in effect. The Secretary
may extend the time in which a certification remains in effect under
this paragraph (b)(1) on a case-by-case basis.
(2) Within 1 year from the date of withdrawal of approval of an
accreditation body, or within any shorter period of time established by
the Secretary, OTPs currently accredited by the accreditation body must
obtain accreditation from another accreditation body. The Secretary may
extend the time period for obtaining reaccreditation on a case-by-case
basis.
Sec. 8.14 Suspension or revocation of certification.
(a) Revocation. Except as provided in paragraph (b) of this
section, the Secretary may revoke the certification of an OTP if the
Secretary finds, after providing the program sponsor with notice and an
opportunity for a hearing in accordance with this subpart, that the
program sponsor, or any employee of the OTP:
(1) Has been found guilty of misrepresentation in obtaining the
certification;
(2) Has failed to comply with the Federal Opioid Use Disorder
treatment standards in any respect;
(3) Has failed to comply with reasonable requests from the
Secretary or from an accreditation body for records, information,
reports, or materials that are necessary to determine the continued
eligibility of the OTP for certification or continued compliance with
the Federal Opioid Use Disorder treatment standards; or
(4) Has refused a reasonable request of a duly designated
inspector, DEA Inspector, State Inspector, or accreditation body
representative for permission to inspect the program or the program's
operations or its records.
(b) Suspension. Whenever the Secretary has reason to believe that
revocation may be required and that immediate action is necessary to
protect public health or safety, the Secretary may immediately suspend
the certification of an OTP, and notify the Attorney General that the
OTP's registration should be suspended, before holding a hearing under
this subpart. The Secretary may immediately suspend as well as propose
revocation of the certification of an OTP before holding a hearing
under this subpart if the Secretary makes a finding described in
paragraph (a) of this section and also determines that:
(1) The failure to comply with the Federal Opioid Use Disorder
treatment standards presents an imminent danger to the public health or
safety;
(2) The refusal to permit inspection makes immediate suspension
necessary; or
(3) There is reason to believe that the failure to comply with the
Federal Opioid Use Disorder treatment standards was intentional or was
associated with fraud.
(c) Written notification. In the event that the Secretary suspends
the certification of an OTP in accordance with paragraph (b) of this
section or proposes to revoke the certification of an OTP in accordance
with paragraph (a) of this section, the Secretary shall promptly
provide the sponsor of the OTP with written notice of the suspension or
proposed revocation by facsimile transmission, personal service,
commercial overnight delivery service, or certified mail, return
receipt requested. Such notice shall state the reasons for the action
and shall state that the OTP may seek review of the action in
accordance with the procedures in this subpart.
(d) Procedure. (1) If the Secretary suspends certification in
accordance with paragraph (b) of this section:
(i) The Secretary will immediately notify DEA that the OTP's
registration should be suspended under 21 U.S.C. 824(d); and
(ii) The Secretary will provide an opportunity for a hearing under
this subpart.
(2) Suspension of certification under paragraph (b) of this section
shall remain in effect until the agency determines that:
(i) The basis for the suspension cannot be substantiated;
[[Page 77361]]
(ii) Violations of required standards have been corrected to the
agency's satisfaction; or
(iii) The OTP's certification shall be revoked.
Sec. 8.15 Forms.
(a) SMA-162--Application for Certification to Use Medications for
Opioid Use Disorder.
(b) SMA-163--Application for Becoming an Accreditation Body under
Sec. 8.3.
Subpart D--Procedures for Review of Suspension or Proposed
Revocation of OTP Certification, and of Adverse Action Regarding
Withdrawal of Approval of an Accreditation Body
Sec. 8.21 Applicability.
The procedures in this subpart apply when:
(a) The Secretary has notified an OTP in writing that its
certification under the regulations in subpart B of this part has been
suspended or that the Secretary proposes to revoke the certification;
and
(b) The OTP has, within 30 days of the date of the notification or
within 3 days of the date of the notification when seeking an expedited
review of a suspension, requested in writing an opportunity for a
review of the suspension or proposed revocation.
(c) The Secretary has notified an accreditation body of an adverse
action taken regarding withdrawal of approval of the accreditation body
under the regulations in subpart A of this part; and
(d) The accreditation body has, within 30 days of the date of the
notification, requested in writing an opportunity for a review of the
adverse action.
Sec. 8.22 Definitions.
The following definitions apply to this subpart:
Appellant means:
(1) The OTP which has been notified of its suspension or proposed
revocation of its certification under the regulations of this part and
has requested a review of the suspension or proposed revocation; or
(2) The accreditation body which has been notified of adverse
action regarding withdrawal of approval under the regulations of this
subpart and has requested a review of the adverse action.
Respondent means SAMHSA.
Reviewing official means the person or persons designated by the
Secretary who will review the suspension or proposed revocation. The
reviewing official may be assisted by one or more Department of Health
and Human Services (HHS) officers or employees or consultants in
assessing and weighing the scientific and technical evidence and other
information submitted by the appellant and respondent on the reasons
for the suspension and proposed revocation.
Sec. 8.23 Limitation on issues subject to review.
The scope of review shall be limited to the facts relevant to any
suspension, or proposed revocation, or adverse action, the necessary
interpretations of the facts, the regulations in this subpart, and
other relevant law.
Sec. 8.24 Specifying who represents the parties.
The appellant's request for review shall specify the name, address,
and phone number of the appellant's representative. In its first
written submission to the reviewing official, the respondent shall
specify the name, address, and phone number of the respondent's
representative.
Sec. 8.25 Informal review and the reviewing official's response.
(a) Request for review. Within 30 days of the date of the notice of
the suspension or proposed revocation, the appellant must submit a
written request to the reviewing official seeking review, unless some
other time period is agreed to by the parties. A copy must also be sent
to the respondent. The request for review must include a copy of the
notice of suspension, proposed revocation, or adverse action, a brief
statement of why the decision to suspend, propose revocation, or take
an adverse action is incorrect, and the appellant's request for an oral
presentation, if desired.
(b) Acknowledgment. Within 5 days after receiving the request for
review, the reviewing official will send an acknowledgment and advise
the appellant of the next steps. The reviewing official will also send
a copy of the acknowledgment to the respondent.
Sec. 8.26 Preparation of the review file and written arguments.
The appellant and the respondent each participate in developing the
file for the reviewing official and in submitting written arguments.
The procedures for development of the review file and submission of
written argument are:
(a) Appellant's documents and brief. Within 30 days after receiving
the acknowledgment of the request for review, the appellant shall
submit to the reviewing official the following (with a copy to the
respondent):
(1) A review file containing the documents supporting appellant's
argument, tabbed and organized chronologically, and accompanied by an
index identifying each document. Only essential documents should be
submitted to the reviewing official.
(2) A written statement, not to exceed 20 double-spaced pages,
explaining why respondent's decision to suspend or propose revocation
of appellant's certification or to take adverse action regarding
withdrawal of approval of the accreditation body is incorrect
(appellant's brief).
(b) Respondent's documents and brief. Within 30 days after
receiving a copy of the acknowledgment of the request for review, the
respondent shall submit to the reviewing official the following (with a
copy to the appellant):
(1) A review file containing documents supporting respondent's
decision to suspend or revoke appellant's certification, or approval as
an accreditation body, tabbed and organized chronologically, and
accompanied by an index identifying each document. Only essential
documents should be submitted to the reviewing official.
(2) A written statement, not exceeding 20 double-spaced pages in
length, explaining the basis for suspension, proposed revocation, or
adverse action (respondent's brief).
(c) Reply briefs. Within 10 days after receiving the opposing
party's submission, or 20 days after receiving acknowledgment of the
request for review, whichever is later, each party may submit a short
reply not to exceed 10 double-spaced pages.
(d) Cooperative efforts. Whenever feasible, the parties should
attempt to develop a joint review file.
(e) Excessive documentation. The reviewing official may take any
appropriate steps to reduce excessive documentation, including the
return of or refusal to consider documentation found to be irrelevant,
redundant, or unnecessary.
(f) Discovery. The use of interrogatories, depositions, and other
forms of discovery shall not be allowed.
Sec. 8.27 Opportunity for oral presentation.
(a) Electing oral presentation. If an opportunity for an oral
presentation is desired, the appellant shall request it at the time it
submits its written request for review to the reviewing official. The
reviewing official will grant the request if the official determines
that the decision-making process will be substantially aided by oral
presentations and arguments. The reviewing official may also provide
for an oral presentation at the official's own
[[Page 77362]]
initiative or at the request of the respondent.
(b) Presiding official. The reviewing official or designee will be
the presiding official responsible for managing the oral presentations.
(c) Preliminary conference. The presiding official may hold a
prehearing conference (usually a telephone conference call) to consider
any of the following: Simplifying and clarifying issues; stipulations
and admissions; limitations on evidence and witnesses that will be
presented at the hearing; time allotted for each witness and the
hearing altogether; scheduling the hearing; and any other matter that
will assist in the review process. Normally, this conference will be
conducted informally and off the record; however, the presiding
official may, at the presiding official's discretion, produce a written
document summarizing the conference or transcribe the conference,
either of which will be made a part of the record.
(d) Time and place of oral presentation. The presiding official
will attempt to schedule the oral presentation within 45 days of the
date appellant's request for review is received or within 15 days of
submission of the last reply brief, whichever is later. The oral
presentation will be held at a time and place determined by the
presiding official following consultation with the parties.
(e) Conduct of the oral presentation--(1) General. The presiding
official is responsible for conducting the oral presentation. The
presiding official may be assisted by one or more HHS officers or
employees or consultants in conducting the oral presentation and
reviewing the evidence. While the oral presentation will be kept as
informal as possible, the presiding official may take all necessary
steps to ensure an orderly proceeding.
(2) Burden of proof/standard of proof. In all cases, the respondent
bears the burden of proving by a preponderance of the evidence that its
decision to suspend, propose revocation, or take adverse action is
appropriate. The appellant, however, has a responsibility to respond to
the respondent's allegations with evidence and argument to show that
the respondent is incorrect.
(3) Admission of evidence. The rules of evidence do not apply and
the presiding official will generally admit all testimonial evidence
unless it is clearly irrelevant, immaterial, or unduly repetitious.
Each party may make an opening and closing statement, may present
witnesses as agreed upon in the pre-hearing conference or otherwise,
and may question the opposing party's witnesses. Since the parties have
ample opportunity to prepare the review file, a party may introduce
additional documentation during the oral presentation only with the
permission of the presiding official. The presiding official may
question witnesses directly and take such other steps necessary to
ensure an effective and efficient consideration of the evidence,
including setting time limitations on direct and cross-examinations.
(4) Motions. The presiding official may rule on motions including,
for example, motions to exclude or strike redundant or immaterial
evidence, motions to dismiss the case for insufficient evidence, or
motions for summary judgment. Except for those made during the hearing,
all motions and opposition to motions, including argument, must be in
writing and be no more than 10 double-spaced pages in length. The
presiding official will set a reasonable time for the party opposing
the motion to reply.
(5) Transcripts. The presiding official shall have the oral
presentation transcribed and the transcript shall be made a part of the
record. Either party may request a copy of the transcript and the
requesting party shall be responsible for paying for its copy of the
transcript.
(f) Obstruction of justice or making of false statements.
Obstruction of justice or the making of false statements by a witness
or any other person may be the basis for a criminal prosecution under
18 U.S.C. 1001 or 1505.
(g) Post-hearing procedures. At the presiding official's
discretion, the presiding official may require or permit the parties to
submit post-hearing briefs or proposed findings and conclusions. Each
party may submit comments on any major prejudicial errors in the
transcript.
Sec. 8.28 Expedited procedures for review of immediate suspension.
(a) Applicability. When the Secretary notifies an OTP in writing
that its certification has been immediately suspended, the appellant
may request an expedited review of the suspension and any proposed
revocation. The appellant must submit this request in writing to the
reviewing official within 10 days of the date the OTP received notice
of the suspension. The request for review must include a copy of the
suspension and any proposed revocation, a brief statement of why the
decision to suspend and propose revocation is incorrect, and the
appellant's request for an oral presentation, if desired. A copy of the
request for review must also be sent to the respondent.
(b) Reviewing official's response. As soon as practicable after the
request for review is received, the reviewing official will send an
acknowledgment with a copy to the respondent.
(c) Review file and briefs. Within 10 days of the date the request
for review is received, but no later than 2 days before an oral
presentation, each party shall submit to the reviewing official the
following:
(1) A review file containing essential documents relevant to the
review, tabbed, indexed, and organized chronologically; and
(2) A written statement, not to exceed 20 double-spaced pages,
explaining the party's position concerning the suspension and any
proposed revocation. No reply brief is permitted.
(d) Oral presentation. If an oral presentation is requested by the
appellant or otherwise granted by the reviewing official in accordance
with Sec. 8.27(a), the presiding official will attempt to schedule the
oral presentation within 20 to 30 days of the date of appellant's
request for review at a time and place determined by the presiding
official following consultation with the parties. The presiding
official may hold a pre-hearing conference in accordance with Sec.
8.27(c) and will conduct the oral presentation in accordance with the
procedures of Sec. 8.27(e) through (g).
(e) Written decision. The reviewing official shall issue a written
decision upholding or denying the suspension or proposed revocation and
will attempt to issue the decision within 7 to 10 days of the date of
the oral presentation or within 3 days of the date on which the
transcript is received or the date of the last submission by either
party, whichever is later. All other provisions set forth in Sec. 8.33
apply.
(f) Transmission of written communications. Because of the
importance of timeliness for the expedited procedures in this section,
all written communications between the parties and between either party
and the reviewing official shall be sent by facsimile transmission,
personal service, or commercial overnight delivery service.
Sec. 8.29 Ex parte communications.
Except for routine administrative and procedural matters, a party
shall not communicate with the reviewing or presiding official without
notice to the other party.
Sec. 8.30 Transmission of written communications by reviewing
official and calculation of deadlines.
(a) Timely review. Because of the importance of a timely review,
the
[[Page 77363]]
reviewing official should normally transmit written communications to
either party by facsimile transmission, personal service, or commercial
overnight delivery service, or certified mail, return receipt
requested, in which case the date of transmission or day following
mailing will be considered the date of receipt. In the case of
communications sent by regular mail, the date of receipt will be
considered 3 days after the date of mailing.
(b) Due date. In counting days, include Saturdays, Sundays, and
holidays. However, if a due date falls on a Saturday, Sunday, or
Federal holiday, then the due date is the next Federal working day.
Sec. 8.31 Authority and responsibilities of the reviewing official.
In addition to any other authority specified in this subpart, the
reviewing official and the presiding official, with respect to those
authorities involving the oral presentation, shall have the authority
to issue orders; examine witnesses; take all steps necessary for the
conduct of an orderly hearing; rule on requests and motions; grant
extensions of time for good reasons; dismiss for failure to meet
deadlines or other requirements; order the parties to submit relevant
information or witnesses; remand a case for further action by the
respondent; waive or modify the procedures in this subpart in a
specific case, usually with notice to the parties; reconsider a
decision of the reviewing official where a party promptly alleges a
clear error of fact or law; and to take any other action necessary to
resolve disputes in accordance with the objectives of the procedures in
this subpart.
Sec. 8.32 Administrative record.
The administrative record of review consists of the review file;
other submissions by the parties; transcripts or other records of any
meetings, conference calls, or oral presentation; evidence submitted at
the oral presentation; and orders and other documents issued by the
reviewing and presiding officials.
Sec. 8.33 Written decision.
(a) Issuance of decision. The reviewing official shall issue a
written decision upholding or denying the suspension, proposed
revocation, or adverse action. The decision will set forth the reasons
for the decision and describe the basis for that decision in the
record. Furthermore, the reviewing official may remand the matter to
the respondent for such further action as the reviewing official deems
appropriate.
(b) Date of decision. The reviewing official will attempt to issue
the decision within 15 days of the date of the oral presentation, the
date on which the transcript is received, or the date of the last
submission by either party, whichever is later. If there is no oral
presentation, the decision will normally be issued within 15 days of
the date of receipt of the last reply brief. Once issued, the reviewing
official will immediately communicate the decision to each party.
(c) Public notice and communications to the DEA. (1) If the
suspension and proposed revocation of OTP certification are upheld, the
revocation of certification will become effective immediately and the
public will be notified by publication of a notice in the Federal
Register. The Secretary will notify DEA within 5 days that the OTP's
registration should be revoked.
(2) If the suspension and proposed revocation of OTP certification
are denied, the revocation will not take effect and the suspension will
be lifted immediately. Public notice will be given by publication in
the Federal Register. The Secretary will notify DEA within 5 days that
the OTP's registration should be restored, if applicable.
Sec. 8.34 Court review of final administrative action; exhaustion of
administrative remedies.
Before any legal action is filed in court challenging the
suspension, proposed revocation, or adverse action, respondent shall
exhaust administrative remedies provided under this subpart, unless
otherwise provided by Federal law. The reviewing official's decision,
under Sec. 8.28(e) or Sec. 8.33(a), constitutes final agency action
as of the date of the decision.
Subpart E [Reserved]
Subpart F--Authorization To Increase Patient Limit to 275 Patients
Sec. 8.610 Practitioner eligibility requirements for a 3-year 275-
patient limit.
The total number of patients that a practitioner may dispense or
prescribe covered medications to at any one time for purposes of 21
U.S.C. 823(g)(2)(B)(iii) is 275 if:
(a) The practitioner possesses a current waiver to treat up to 100
patients with OUD under section 303(g)(2) of the Controlled Substances
Act (21 U.S.C. 823(g)(2)) and has maintained the waiver in accordance
with applicable statutory requirements without interruption for at
least one year since the practitioner's notification of intent (NOI)
under section 303(g)(2)(B) to treat up to 100 patients was approved;
(b) The practitioner:
(1) Holds additional credentialing as defined in Sec. 8.2; or
(2) Provides OUD treatment utilizing covered medications in a
qualified practice setting as defined in Sec. 8.615;
(c) The practitioner has not had his or her enrollment and billing
privileges in the Medicare program revoked under Sec. 424.535 of this
title; and
(d) The practitioner has not been found to have violated the
Controlled Substances Act pursuant to 21 U.S.C. 824(a).
Sec. 8.615 Definition of a qualified practice setting.
A qualified practice setting is a practice setting that:
(a) Provides professional coverage for patient medical emergencies
during hours when the practitioner's practice is closed;
(b) Provides access to case-management services for patients
including referral and follow-up services for programs that provide, or
financially support, the provision of services such as physical,
behavioral, social, housing, employment, educational, or other related
services;
(c) Uses health information technology (health IT) systems such as
electronic health records, if otherwise required to use these systems
in the practice setting. Health IT means the electronic systems that
health care professionals and patients use to store, share, and analyze
health information;
(d) Is registered for their State prescription drug monitoring
program (PDMP) where operational and in accordance with Federal and
State law. PDMP means a statewide electronic database that collects
designated data on controlled medications dispensed in the State. For
practitioners providing care in their capacity as employees or
contractors of a Federal Government agency, participation in a PDMP is
required only when such participation is not restricted based on their
State of licensure and is in accordance with Federal statutes and
regulations; and
(e) Accepts third-party payment for costs in providing health
services, including written billing, credit, and collection policies
and procedures, or Federal health benefits.
Sec. 8.620 Applying for a 275-patient limit.
In order for a practitioner to receive approval for a 3-year
patient limit of 275, a practitioner must meet all of the requirements
specified in Sec. 8.610 and submit a Request for Patient Limit
Increase to the Secretary that includes all of the following:
[[Page 77364]]
(a) Completed Request for Patient Limit Increase form;
(b) Statement certifying that the practitioner:
(1) Will adhere to nationally recognized evidence-based guidelines
for the treatment of patients with OUD;
(2) Will provide patients with necessary behavioral health services
as defined in Sec. 8.2 or through an established formal agreement with
another entity to provide behavioral health services;
(3) Will provide appropriate releases of information, in accordance
with Federal and State laws and regulations, including the Health
Information Portability and Accountability Act Privacy Rule (45 CFR
part 160 and 45 CFR part 164, subparts A and E) and 42 CFR part 2, if
applicable, to permit the coordination of care with behavioral health,
medical, and other service practitioners;
(4) Will use patient data to inform the improvement of outcomes;
(5) Will adhere to a diversion control plan to manage the covered
medications and reduce the possibility of diversion of covered
medications from prescribed treatment use;
(6) Has considered how to assure continuous access to care in the
event of practitioner incapacity or an emergency-situation that would
impact a patient's access to care as defined in Sec. 8.2; and
(7) Will notify all patients above the 100-patient level, in the
event that the request for the higher patient limit is not renewed or
the renewal request is denied, that the practitioner will no longer be
able to provide buprenorphine treatment to them and make every effort
to transfer patients to other treatment providers; and
(c) Any additional documentation to demonstrate compliance with
Sec. 8.610 as requested by the Secretary.
Sec. 8.625 Processing a 275 Request for Patient Limit Increase.
(a) Not later than 45 days after the date on which the Secretary
receives a practitioner's Request for Patient Limit Increase as
described in Sec. 8.620, or renewal Request for Patient Limit Increase
as described in Sec. 8.640, the Secretary shall approve or deny the
request.
(1) A practitioner's Request for Patient Limit Increase will be
approved if the practitioner satisfies all applicable requirements
under Sec. Sec. 8.610 and 8.620. The Secretary will thereafter notify
the practitioner who requested the patient limit increase, and the DEA,
that the practitioner has been approved to treat up to 275 patients
using covered medications. A practitioner's approval to treat up to 275
patients under this section will extend for a term not to exceed 3
years.
(2) The Secretary may deny a practitioner's Request for Patient
Limit Increase if the Secretary determines that:
(i) The Request for Patient Limit Increase is deficient in any
respect; or
(ii) The practitioner has knowingly submitted false statements or
made misrepresentations of fact in the practitioner's Request for
Patient Limit Increase.
(b) If the Secretary denies a practitioner's Request for Patient
Limit Increase (or renewal), the Secretary shall notify the
practitioner of the reasons for the denial.
(c) If the Secretary denies a practitioner's Request for Patient
Limit Increase (or renewal) based solely on deficiencies that can be
resolved, and the deficiencies are resolved to the satisfaction of the
Secretary in a manner and time period approved by the Secretary, the
practitioner's Request for Patient Limit Increase will be approved. If
the deficiencies have not been resolved to the satisfaction of the
Secretary within the designated time period, the Request for Patient
Limit Increase may be denied.
Sec. 8.630 Practitioner requirements to maintain a 275-patient limit.
A practitioner whose Request for Patient Limit Increase is approved
in accordance with Sec. 8.625 shall maintain all eligibility
requirements specified in Sec. 8.610, and all attestations made in
accordance with Sec. 8.620(b), during the practitioner's 3-year
approval term. Failure to do so may result in the Secretary withdrawing
its approval of a practitioner's Request for Patient Limit Increase.
Sec. 8.640 Renewal process for a 3-year 275 Request for Patient Limit
Increase.
(a) Practitioners who intend to continue to treat up to 275
patients beyond their current 3-year approval term must submit a
renewal Request for Patient Limit Increase in accordance with the
procedures outlined under Sec. 8.620 no more than 30 days before the
expiration of their current approval term.
(b) If the Secretary does not reach a final decision on a renewal
Request for Patient Limit Increase before the expiration of a
practitioner's approval term, the practitioner's existing approval term
will be deemed extended until the Secretary reaches a final decision.
Sec. 8.645 Practitioner responsibility when no renewal request for
patient limit increase is submitted, or whose renewal request is
denied.
Practitioners who are approved to treat up to 275 patients in
accordance with Sec. 8.625, but who do not renew their Request for
Patient Limit Increase, or whose renewal request is denied, shall
notify, under Sec. 8.620(b)(7) in a time period specified by the
Secretary, all patients affected above the 100-patient limit, that the
practitioner will no longer be able to provide OUD treatment services
using covered medications and make every effort to transfer patients to
other treatment providers.
Sec. 8.650 Suspension or revocation of the Secretary's approval of a
practitioner's request for patient limit increase.
The Secretary, at any time during a practitioner's 3-year approval
term, may suspend or revoke its approval of a practitioner's Request
for Patient Limit Increase under Sec. 8.625 if it is determined that:
(a) Immediate action is necessary to protect public health or
safety;
(b) The practitioner made misrepresentations in the practitioner's
Request for Patient Limit Increase;
(c) The practitioner no longer satisfies the requirements of this
subpart; or
(d) The practitioner has been found to have violated the CSA
pursuant to 21 U.S.C. 824(a).
Sec. 8.655 Temporary increase to treat up to 275 patients in
emergency situations.
(a) Practitioners with a current waiver to prescribe up to 100
patients and who are not otherwise eligible to treat up to 275 patients
under Sec. 8.610 may request a temporary increase of 6-months to treat
up to 275 patients in order to address emergency situations as defined
in Sec. 8.2. Practitioners may not be granted more than 2 consecutive
emergency 275-patient limit requests. To apply for a 6-month emergency
275-patient limit, the practitioner must provide information and
documentation that:
(1) Describes the emergency situation in sufficient detail so as to
allow a determination to be made regarding whether the situation
qualifies as an emergency situation as defined in Sec. 8.2, and that
provides a justification for an immediate increase in that
practitioner's patient limit;
(2) Identifies a period of time, not longer than 6 months, in which
the higher patient limit should apply, and provides a rationale for the
period of time requested; and
(3) Describes an explicit and feasible plan to meet the public and
individual
[[Page 77365]]
health needs of the impacted persons once the practitioner's approval
to treat up to 275 patients expires.
(b) Prior to taking action on a practitioner's request under this
section, the Secretary shall consult, to the extent practicable, with
the appropriate governmental authorities in order to determine whether
the emergency situation that a practitioner describes justifies an
immediate increase in the higher patient limit.
(c) If the Secretary determines that a practitioner's request under
this section should be granted, the Secretary will notify the
practitioner that his or her request has been approved. The period of
such approval shall not exceed six months.
(d) If practitioners wish to receive an extension of the approval
period granted under this section, they must submit a request to the
Secretary at least 30 days before the expiration of the six-month
period and certify that the emergency situation as defined in Sec. 8.2
necessitating an increased patient limit continues. Prior to taking
action on a practitioner's extension request under this section, the
Secretary shall consult, to the extent practicable, with the
appropriate governmental authorities in order to determine whether the
emergency situation that a practitioner describes justifies an
extension of an increase in the higher patient limit.
(e) Except as provided in this section and Sec. 8.650,
requirements in other sections under this subpart do not apply to
practitioners receiving waivers in this section.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2022-27193 Filed 12-13-22; 8:45 am]
BILLING CODE P
