Proposed Rule2023-03012
Medications for the Treatment of Opioid Use Disorder: Removal of the DATA-2000 Waiver Requirements
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 13, 2023
Issuing agencies
Health and Human Services Department
Abstract
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 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).
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 29 (Monday, February 13, 2023)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
<bullet> Federal eRulemaking Portal: You may submit electronic
comments at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the instructions at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>, 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:
<a href="/cdn-cgi/l/email-protection#da88b5b8bfa8aef498bbb3b6b6b3bfaf9aa9bbb7b2a9bbf4b2b2a9f4bdb5ac"><span class="__cf_email__" data-cfemail="42102d202730366c00232b2e2e2b27370231232f2a31236c2a2a316c252d34">[email protected]</span></a>.
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]]
<a href="http://www.regulations.gov">www.regulations.gov</a> 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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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]
BILLING CODE P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on February 13, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.