Medications for the Treatment of Opioid Use Disorder: Removal of the DATA-2000 Waiver Requirements, 9221-9224 [2023-03012]
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Federal Register / Vol. 88, No. 29 / Monday, February 13, 2023 / Proposed Rules
9.3
USPS Marketing Mail
9.3.1 Basic Standards
Bundles of flats in an automation
price mailing must be cosacked with
bundles of flats in a Presorted price
mailing under the following conditions:
*
*
*
*
*
[Revise the first sentence of item h to
read as follows:]
h. A complete postage statement(s),
using the correct USPS form, must
accompany each mailing job prepared
under these procedures. * * *
*
*
*
*
*
9.4
Bound Printed Matter
9.4.1 Basic Standards
Bundles of flat-size pieces in a
Presorted price mailing qualifying for
and claiming the barcode discount
under 263.3.0, 263.2.0, and 263.5.0 must
be cosacked with bundles of flat-size
pieces from a Presorted price mailing
(not claiming the barcode discount)
under the following conditions:
*
*
*
*
*
[Revise the first sentence of item h to
read as follows:]
h. A complete postage statement(s),
using the correct USPS form, must
accompany each mailing job prepared
under these procedures. * * *
*
*
*
*
*
10.0 Merging Bundles of Flats Using
the City State Product
10.1
Periodicals
10.1.1 Basic Standards
* * * Carrier route bundles in a
carrier route mailing may be placed in
the same sack or on the same pallet as
5-digit bundles from machinable
(barcoded or nonbarcoded) price
mailings (including pieces cobundled
under 11.0) under the following
conditions:
*
*
*
*
*
[Revise the first sentence of item i to
read as follows:]
i. A complete postage statement(s),
using the correct USPS form, must
accompany each mailing job prepared
under these procedures. * * *
*
*
*
*
*
khammond on DSKJM1Z7X2PROD with PROPOSALS
10.2
USPS Marketing Mail
10.2.1 Basic Standards
Carrier route bundles from a carrier
route price mailing may be placed in the
same sack or on the same pallet as 5digit bundles from an automation price
mailing and 5-digit bundles from a
Presorted price mailing (including
pieces cobundled under 11.0) under the
following conditions:
*
*
*
*
*
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[Revise the text of item k to read as
follows:]
k. A complete postage statement,
using the correct USPS form, must
accompany each mailing job prepared
under these procedures.
*
*
*
*
*
12.0 Merging Bundles of Flats on
Pallets Using a 5% Threshold
12.1
Periodicals
12.1.1 Basic Standards
* * * Five-digit bundles from a
barcoded price mailing and 5-digit
bundles from a nonbarcoded price
mailing (including pieces cobundled
under 11.0) may be placed on the same
pallet as carrier route bundles under the
following conditions:
*
*
*
*
*
[Revise the first sentence in the
introductory text of item f to read as
follows:]
f. A complete postage statement, using
the correct USPS form, must accompany
each mailing job. * * *
*
*
*
*
*
12.2
USPS Marketing Mail
12.2.1 Basic Standards
* * * Five-digit bundles from an
automation price mailing and 5-digit
bundles from a Presorted price mailing
(including pieces cobundled under 11.0)
may be placed on the same pallet as
carrier route bundles under the
following conditions:
*
*
*
*
*
[Revise the text of item j to read as
follows:]
j. A complete postage statement, using
the correct USPS form, must be
submitted for each mailing job prepared
under these procedures.
*
*
*
*
*
13.0 Merging Bundles of Flats on
Pallets Using the City State Product and
a 5% Threshold
13.1
Periodicals
13.1.1 Basic Standards
* * * Five-digit bundles from a
barcoded price mailing and 5-digit
bundles from a nonbarcoded price
mailing (including pieces cobundled
under 11.0) may be placed on the same
pallet as carrier route bundles under the
following conditions:
*
*
*
*
*
[Revise the first sentence in the
introductory text of item g to read as
follows:]
g. A complete postage statement,
using the correct USPS form, must be
submitted for each mailing job. * * *
*
*
*
*
*
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13.2
9221
USPS Marketing Mail
13.2.1 Basic Standards
* * * Five-digit bundles from an
automation price mailing and 5-digit
bundles from a Presorted price mailing
(including pieces cobundled under 11.0)
may be placed on the same pallet as
carrier route bundles under the
following conditions:
*
*
*
*
*
[Revise the text of item k to read as
follows:]
k. A complete postage statement,
using the correct USPS form, must be
submitted for each mailing job prepared
under these procedures.
*
*
*
*
*
17.0
*
17.2
*
Plant-Verified Drop Shipment
*
*
*
*
Program Participation
*
*
*
*
17.2.3 Verification at Origin BMEU
PVDS verification can be performed at
the origin business mail entry unit
(BMEU) under these conditions:
*
*
*
*
*
[Revise the text of item d to read as
follows:]
d. Form 8125 accompanies each PVDS
(or segment, if the PVDS is contained in
more than one vehicle).
*
*
*
*
*
Tram T. Pham,
Attorney, Ethics and Legal Compliance.
[FR Doc. 2023–02824 Filed 2–10–23; 8:45 am]
BILLING CODE P
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: Removal of the
DATA–2000 Waiver Requirements
Substance Abuse and Mental
Health Services Administration
(SAMHSA), Department of Health and
Human Services.
ACTION: Supplemental notice of
proposed rulemaking.
AGENCY:
The Department of Health and
Human Services (HHS or ‘‘the
Department’’) is issuing this
supplemental notice of proposed
rulemaking (SNPRM) to solicit public
comment on its proposal to remove
provisions authorized under the
SUMMARY:
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Federal Register / Vol. 88, No. 29 / Monday, February 13, 2023 / Proposed Rules
Controlled Substances Act (CSA), as
amended by the Drug Addiction
Treatment Act of 2000 (DATA–2000).
These changes are as a result of
amendments made in the Consolidated
Appropriations Act, 2023, which was
enacted on December 29, 2022. Among
other things, section 1262(a)(1) of this
Act amended the CSA by eliminating
the requirement that practitioners obtain
a waiver to prescribe certain schedule
III–V medications for the treatment of
opioid use disorder (OUD).
DATES: Comments due on or before
March 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.
khammond on DSKJM1Z7X2PROD with PROPOSALS
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.
VerDate Sep<11>2014
16:34 Feb 10, 2023
Jkt 259001
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.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
Purpose
The purpose of this supplemental
notice of proposed rulemaking (SNPRM)
is to implement amendments made by
the Consolidated Appropriations Act,
2023 (Pub. L. 117–328), which
immediately eliminated the requirement
to obtain a waiver in order to prescribe
certain schedule III–V medications for
the treatment of OUD, commonly
known as the ‘‘X waiver.’’ Accordingly,
the Department is proposing to formally
remove DATA 2000 related provisions
(formerly under 21 U.S.C. 823(h)(2))
from 42 CFR part 8, which no longer
have practical or legal effect on medical
provider practices under existing law.1
Before the Consolidated
Appropriations Act, 2023 was enacted,
‘‘qualifying practitioners’’ were required
to obtain waivers (formerly under 21
U.S.C. 823(h)(2)) from a separate
registration requirement, formerly under
21 U.S.C. 823(h)(1), that was needed in
order to enable dispensing of certain
schedule III–V narcotic medications
used in maintenance or detoxification
treatment. Practitioners with a waiver of
this kind were limited in the number of
patients they could treat with this type
of medication at any one time.
In July 2016, the Department
published a final rule (81 FR 44711) that
added subpart F to 42 CFR part 8 under
the authority of former 21 U.S.C.
823(h)(2)(B)(iii)(III). Among other
things, subpart F authorized eligible
practitioners with a waiver under 21
U.S.C. 823(h)(2) to request approval to
treat up to 275 patients under certain
conditions. On December 16, 2022, the
Department published an NPRM
proposing three changes to subpart F:
(1) altering section headings to remove
the current question-and-answer style
and replacing it with a standard format;
(2) updating § 8.610 to remove
stigmatizing language and to also clarify
that the 275-patient waiver is limited to
three years in duration and; (3)
removing § 8.635 to eliminate annual
reporting requirements for practitioners
approved to treat up to 275 patients. See
NPRM entitled ‘‘Medications for the
1 It should be noted that Section 103(a)(1) of
Public Law 117–215 redesignated 21 U.S.C. 823(g)
as 21 U.S.C. 823(h).
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Treatment of Opioid Use Disorder’’ (87
FR 77330).
II. Summary of Major Provisions
Pursuant to section 1262 of the
Consolidated Appropriations Act, 2023,
the Department proposes to remove in
its entirety subpart F of 42 CFR part 8
in addition to language throughout 42
CFR part 8 that specifically references or
implicates the DATA–2000 waiver
process. The terms DATA–2000 waiver
and DATA-waiver used throughout this
document refer to the waiver provisions
under 21 U.S.C. 823(h)(2) in effect prior
to amendment by the Consolidated
Appropriations Act, 2023 (Pub. L. 117–
328). Although not used in this
document, the DATA-waiver has also
colloquially been referred to as the ‘‘Xwaiver’’.
III. Summary of Impacts
As the specific changes proposed in
this SNPRM are in conformity with
amendments made by section 1262(a)(1)
of the Consolidated Appropriations Act,
2023 (Pub. L. 117–328), these changes
will have no practical or legal effect on
medical provider practices under
existing law.
Public Participation
Request for Comments
In addition to seeking public
comments on the full NPRM published
December 16, 2022, the Department
requests public comment on this
Supplemental proposed amendment to
the regulations under 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.
The Department seeks comment on all
issues raised by the proposed changes
consistent with the law, including any
potential unintended adverse
consequences, and benefits to people
with opioid use disorders. 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
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Federal Register / Vol. 88, No. 29 / Monday, February 13, 2023 / Proposed Rules
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.
khammond on DSKJM1Z7X2PROD with PROPOSALS
V. Background
On December 16, 2022, HHS issued a
notice of proposed rulemaking entitled
‘‘Medications for the Treatment of
Opioid Use Disorder’’ (87 FR 77330). In
that NPRM, the Department proposed to
modify certain provisions of part 8 to
update Opioid Treatment Program
(OTP) accreditation and certification
standards, treatment standards for the
provision of medications for opioid use
disorder as dispensed by OTPs, and
requirements for individual
practitioners eligible to dispense
(including by prescribing) certain types
of Medication for Opioid Use Disorder
(MOUD) with a waiver under 21 U.S.C.
823(h)(2). Subparts A through D of 42
CFR part 8 pertain to OTP accreditation,
certification and treatment standards.
Within these sections, there are no
specific rules that pertain to the DATAWaiver. Subpart F of this rulemaking
provides criteria to expand access to
buprenorphine by allowing eligible
practitioners to request approval to treat
up to 275 patients.
On December 29, 2022, the President
signed the ‘‘Consolidated
Appropriations Act, 2023’’ (Pub. L. 117–
328). Section 1262 of the Act amends
the Controlled Substances Act (21
U.S.C. 823(h)) and provisions in the
Public Health Service Act 2 to remove
the requirement that practitioners obtain
a special waiver to prescribe certain
medications, including buprenorphine,
for the treatment of OUD.
The proposed changes in this SNPRM
remove all language pertaining to the
DATA-Waiver from 42 CFR part 8,
pursuant to the ‘‘Consolidated
Appropriations Act, 2023’’ and the
changes proposed in this SNPRM that
pertain to 42 CFR part 8, subpart F
replace and supersede any subpart F
changes proposed in the Department’s
December 16, 2022, NPRM (87 FR
77330). Any other proposed changes in
this SNPRM are a supplement to the
NPRM published on December 16, 2022
(87 FR 77330).
VI. Summary of the SNPRM
In compliance with section 1262 of
the Consolidated Appropriations Act,
2023, this supplemental NPRM
2 Specifically, section 1262 of the Act amends
provisions in the Public Health Service Act (42
U.S.C. 290bb–36d(c); and 42 U.S.C. 290dd–3) that
reference practitioners dispensing MOUD pursuant
to 21 U.S.C. 823(h).
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Jkt 259001
proposes changes to 42 CFR part 8, and
revises some of the Department’s
proposals published on December 16,
2022 (87 FR 77330). These changes
include removing 42 CFR part 8, subpart
F, eliminating references to the DATAwaiver from 42 CFR part 8, subpart A,
§ 8.1, and modifying definitions in
subpart A accordingly.
Impact Analysis
The Department has examined the
impact of these proposed changes 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), and included it in the NPRM
published on December 16, 2022. Please
refer to the NPRM for this analysis (87
FR 77330). The Department requests
comment on how the previouslyconducted analysis should be revised to
encompass the effects of the CFR
changes set forth in this SNPRM.
List of Subjects in 42 CFR Part 8
Administrative practice and
procedure, Health professions,
Methadone, Reporting and
recordkeeping requirements, Substance
misuse.
For the reasons stated in the
preamble, the Department of Health and
Human Services proposes to
supplement its December 16, 2022
NPRM (87 FR 77330) by further
amending 42 CFR part 8 as follows:
■ 1. The authority citation for part 8
continues to read as follows:
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9223
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
■
2. Revise § 8.1 to read as follows:
§ 8.1
Scope.
This subpart and subparts B through
D of this part establish the procedures
by which the Secretary of Health and
Human Services (the Secretary) will
determine whether an applicant seeking
to become an Opioid Treatment Program
(OTP) is qualified under section 303(h)
of the Controlled Substances Act (CSA)
(21 U.S.C. 823(h)) to dispense
Medications for Opioid Use Disorder
(MOUD) in the treatment of Opioid Use
Disorder (OUD), and establishes the
Secretary’s standards regarding the
appropriate quantities of MOUD that
may be provided for unsupervised use
by individuals undergoing such
treatment (21 U.S.C. 823(h)). Under this
subpart and subparts B through D, an
applicant seeking to become an OTP
must first obtain from the Secretary or,
by delegation, from the Assistant
Secretary for Mental Health and
Substance Use, a certification that the
applicant is qualified under the
Secretary’s standards and will comply
with such standards. Eligibility for
certification will depend upon the
applicant obtaining accreditation from
an accreditation body that has been
approved by the Secretary. This subpart
and subparts B through D also establish
the procedures whereby an entity can
apply to become an approved
accreditation body, and the
requirements and general standards for
accreditation bodies to ensure that OTPs
are consistently evaluated for
compliance with the Secretary’s
standards for treatment of OUD with
MOUD.
■ 2. Amend § 8.2 by:
■ a. Removing the definitions for
Additional credentialing, Approval
term, Covered medications, and
Emergency situation.
■ b. Revising the definition for Patient.
■ c. Removing the definition for Patient
limit.
■ d. Revising the definition for
Practitioner.
■ e. Removing the definition for
Practitioner incapacity.
The revisions read as follows:
§ 8.2
Definitions.
*
*
*
*
*
Patient, for purposes of this part,
means any individual who receives
continuous treatment or withdrawal
management in an OTP.
*
*
*
*
*
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Practitioner, for purposes of this part,
means a health care professional who is
appropriately licensed by a state to
prescribe and/or dispense medications
for opioid use disorders and is
authorized to practice within an OTP.
*
*
*
*
*
Subpart F—[Removed]
4. Remove subpart F, consisting of
§§ 8.610 through 8.655.
■
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2023–03012 Filed 2–10–23; 8:45 am]
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]]>Agencies
[Federal Register Volume 88, Number 29 (Monday, February 13, 2023)]
[Proposed Rules]
[Pages 9221-9224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03012]
=======================================================================
-----------------------------------------------------------------------
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: Removal of
the DATA-2000 Waiver Requirements
AGENCY: Substance Abuse and Mental Health Services Administration
(SAMHSA), Department of Health and Human Services.
ACTION: Supplemental notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS or ``the
Department'') is issuing this supplemental notice of proposed
rulemaking (SNPRM) to solicit public comment on its proposal to remove
provisions authorized under the
[[Page 9222]]
Controlled Substances Act (CSA), as amended by the Drug Addiction
Treatment Act of 2000 (DATA-2000). These changes are as a result of
amendments made in the Consolidated Appropriations Act, 2023, which was
enacted on December 29, 2022. Among other things, section 1262(a)(1) of
this Act amended the CSA by eliminating the requirement that
practitioners obtain a waiver to prescribe certain schedule III-V
medications for the treatment of opioid use disorder (OUD).
DATES: Comments due on or before March 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:
I. Executive Summary
Purpose
The purpose of this supplemental notice of proposed rulemaking
(SNPRM) is to implement amendments made by the Consolidated
Appropriations Act, 2023 (Pub. L. 117-328), which immediately
eliminated the requirement to obtain a waiver in order to prescribe
certain schedule III-V medications for the treatment of OUD, commonly
known as the ``X waiver.'' Accordingly, the Department is proposing to
formally remove DATA 2000 related provisions (formerly under 21 U.S.C.
823(h)(2)) from 42 CFR part 8, which no longer have practical or legal
effect on medical provider practices under existing law.\1\
---------------------------------------------------------------------------
\1\ It should be noted that Section 103(a)(1) of Public Law 117-
215 redesignated 21 U.S.C. 823(g) as 21 U.S.C. 823(h).
---------------------------------------------------------------------------
Before the Consolidated Appropriations Act, 2023 was enacted,
``qualifying practitioners'' were required to obtain waivers (formerly
under 21 U.S.C. 823(h)(2)) from a separate registration requirement,
formerly under 21 U.S.C. 823(h)(1), that was needed in order to enable
dispensing of certain schedule III-V narcotic medications used in
maintenance or detoxification treatment. Practitioners with a waiver of
this kind were limited in the number of patients they could treat with
this type of medication at any one time.
In July 2016, the Department published a final rule (81 FR 44711)
that added subpart F to 42 CFR part 8 under the authority of former 21
U.S.C. 823(h)(2)(B)(iii)(III). Among other things, subpart F authorized
eligible practitioners with a waiver under 21 U.S.C. 823(h)(2) to
request approval to treat up to 275 patients under certain conditions.
On December 16, 2022, the Department published an NPRM proposing three
changes to subpart F: (1) altering section headings to remove the
current question-and-answer style and replacing it with a standard
format; (2) updating Sec. 8.610 to remove stigmatizing language and to
also clarify that the 275-patient waiver is limited to three years in
duration and; (3) removing Sec. 8.635 to eliminate annual reporting
requirements for practitioners approved to treat up to 275 patients.
See NPRM entitled ``Medications for the Treatment of Opioid Use
Disorder'' (87 FR 77330).
II. Summary of Major Provisions
Pursuant to section 1262 of the Consolidated Appropriations Act,
2023, the Department proposes to remove in its entirety subpart F of 42
CFR part 8 in addition to language throughout 42 CFR part 8 that
specifically references or implicates the DATA-2000 waiver process. The
terms DATA-2000 waiver and DATA-waiver used throughout this document
refer to the waiver provisions under 21 U.S.C. 823(h)(2) in effect
prior to amendment by the Consolidated Appropriations Act, 2023 (Pub.
L. 117-328). Although not used in this document, the DATA-waiver has
also colloquially been referred to as the ``X-waiver''.
III. Summary of Impacts
As the specific changes proposed in this SNPRM are in conformity
with amendments made by section 1262(a)(1) of the Consolidated
Appropriations Act, 2023 (Pub. L. 117-328), these changes will have no
practical or legal effect on medical provider practices under existing
law.
Public Participation
Request for Comments
In addition to seeking public comments on the full NPRM published
December 16, 2022, the Department requests public comment on this
Supplemental proposed amendment to the regulations under 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.
The Department seeks comment on all issues raised by the proposed
changes consistent with the law, including any potential unintended
adverse consequences, and benefits to people with opioid use disorders.
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
[[Page 9223]]
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.
V. Background
On December 16, 2022, HHS issued a notice of proposed rulemaking
entitled ``Medications for the Treatment of Opioid Use Disorder'' (87
FR 77330). In that NPRM, the Department proposed to modify certain
provisions of part 8 to update Opioid Treatment Program (OTP)
accreditation and certification standards, treatment standards for the
provision of medications for opioid use disorder as dispensed by OTPs,
and requirements for individual practitioners eligible to dispense
(including by prescribing) certain types of Medication for Opioid Use
Disorder (MOUD) with a waiver under 21 U.S.C. 823(h)(2). Subparts A
through D of 42 CFR part 8 pertain to OTP accreditation, certification
and treatment standards. Within these sections, there are no specific
rules that pertain to the DATA-Waiver. Subpart F of this rulemaking
provides criteria to expand access to buprenorphine by allowing
eligible practitioners to request approval to treat up to 275 patients.
On December 29, 2022, the President signed the ``Consolidated
Appropriations Act, 2023'' (Pub. L. 117-328). Section 1262 of the Act
amends the Controlled Substances Act (21 U.S.C. 823(h)) and provisions
in the Public Health Service Act \2\ to remove the requirement that
practitioners obtain a special waiver to prescribe certain medications,
including buprenorphine, for the treatment of OUD.
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\2\ Specifically, section 1262 of the Act amends provisions in
the Public Health Service Act (42 U.S.C. 290bb-36d(c); and 42 U.S.C.
290dd-3) that reference practitioners dispensing MOUD pursuant to 21
U.S.C. 823(h).
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The proposed changes in this SNPRM remove all language pertaining
to the DATA-Waiver from 42 CFR part 8, pursuant to the ``Consolidated
Appropriations Act, 2023'' and the changes proposed in this SNPRM that
pertain to 42 CFR part 8, subpart F replace and supersede any subpart F
changes proposed in the Department's December 16, 2022, NPRM (87 FR
77330). Any other proposed changes in this SNPRM are a supplement to
the NPRM published on December 16, 2022 (87 FR 77330).
VI. Summary of the SNPRM
In compliance with section 1262 of the Consolidated Appropriations
Act, 2023, this supplemental NPRM proposes changes to 42 CFR part 8,
and revises some of the Department's proposals published on December
16, 2022 (87 FR 77330). These changes include removing 42 CFR part 8,
subpart F, eliminating references to the DATA-waiver from 42 CFR part
8, subpart A, Sec. 8.1, and modifying definitions in subpart A
accordingly.
Impact Analysis
The Department has examined the impact of these proposed changes 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), and included it in the NPRM
published on December 16, 2022. Please refer to the NPRM for this
analysis (87 FR 77330). The Department requests comment on how the
previously-conducted analysis should be revised to encompass the
effects of the CFR changes set forth in this SNPRM.
List of Subjects in 42 CFR Part 8
Administrative practice and procedure, Health professions,
Methadone, Reporting and recordkeeping requirements, Substance misuse.
For the reasons stated in the preamble, the Department of Health
and Human Services proposes to supplement its December 16, 2022 NPRM
(87 FR 77330) by further amending 42 CFR part 8 as follows:
0
1. The authority citation for part 8 continues to read as follows:
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
0
2. Revise Sec. 8.1 to read as follows:
Sec. 8.1 Scope.
This subpart and subparts B through D of this part establish the
procedures by which the Secretary of Health and Human Services (the
Secretary) will determine whether an applicant seeking to become an
Opioid Treatment Program (OTP) is qualified under section 303(h) of the
Controlled Substances Act (CSA) (21 U.S.C. 823(h)) to dispense
Medications for Opioid Use Disorder (MOUD) in the treatment of Opioid
Use Disorder (OUD), and establishes the Secretary's standards regarding
the appropriate quantities of MOUD that may be provided for
unsupervised use by individuals undergoing such treatment (21 U.S.C.
823(h)). Under this subpart and subparts B through D, an applicant
seeking to become an OTP must first obtain from the Secretary or, by
delegation, from the Assistant Secretary for Mental Health and
Substance Use, a certification that the applicant is qualified under
the Secretary's standards and will comply with such standards.
Eligibility for certification will depend upon the applicant obtaining
accreditation from an accreditation body that has been approved by the
Secretary. This subpart and subparts B through D also establish the
procedures whereby an entity can apply to become an approved
accreditation body, and the requirements and general standards for
accreditation bodies to ensure that OTPs are consistently evaluated for
compliance with the Secretary's standards for treatment of OUD with
MOUD.
0
2. Amend Sec. 8.2 by:
0
a. Removing the definitions for Additional credentialing, Approval
term, Covered medications, and Emergency situation.
0
b. Revising the definition for Patient.
0
c. Removing the definition for Patient limit.
0
d. Revising the definition for Practitioner.
0
e. Removing the definition for Practitioner incapacity.
The revisions read as follows:
Sec. 8.2 Definitions.
* * * * *
Patient, for purposes of this part, means any individual who
receives continuous treatment or withdrawal management in an OTP.
* * * * *
[[Page 9224]]
Practitioner, for purposes of this part, means a health care
professional who is appropriately licensed by a state to prescribe and/
or dispense medications for opioid use disorders and is authorized to
practice within an OTP.
* * * * *
Subpart F--[Removed]
0
4. Remove subpart F, consisting of Sec. Sec. 8.610 through 8.655.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-03012 Filed 2-10-23; 8:45 am]
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