[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]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

42 CFR Part 8

RIN 0930-AA39


Medications for the Treatment of Opioid Use Disorder: 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.

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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\
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    \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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    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

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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.
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2. Amend Sec.  8.2 by:
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a. Removing the definitions for Additional credentialing, Approval 
term, Covered medications, and Emergency situation.
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b. Revising the definition for Patient.
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c. Removing the definition for Patient limit.
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d. Revising the definition for Practitioner.
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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.
* * * * *

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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]

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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