[Federal Register Volume 83, Number 6 (Tuesday, January 9, 2018)]
[Notices]
[Pages 1041-1042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00150]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Confidentiality of Substance Use Disorder Patient Records

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Substance Abuse and Mental Health Services Administration 
(SAMHSA) announces that it will hold a public listening session on 
Wednesday, January 31, 2018, to solicit information concerning the 
Confidentiality of Substance Use Disorder Patient Records regulations 
as required by Section 11002 of the 21st Century Cures Act. The 
listening session will provide an opportunity for the public to provide 
input to SAMHSA concerning the effect of part 2 on ``patient care, 
health outcomes, and patient privacy'' as well as potential regulatory 
changes and future subregulatory guidance.

DATES: The listening session will be held on Wednesday, January 31, 
2018, from 8:30 a.m. (Eastern) to 1:00 p.m. (Eastern).

FOR FURTHER INFORMATION CONTACT: For information concerning the 
listening session, please contact Rachel Karton, Senior Legislative and 
Regulatory Analyst, SAMHSA, 5600 Fishers Lane, Rockville, MD 20857, 
(240) 276-0416 or email [email protected].

SUPPLEMENTARY INFORMATION: 
    Participation: The Listening Session proceeding will be recorded, 
and subsequently archived and posted on the SAMHSA website. The public 
may attend the listening session:
     Via Teleconference/Webcast: The entire proceeding will be 
streamed live over the internet (requires prior registration). Audio 
and streaming information will be sent to those who register prior to 
the meeting. Capacity for the Teleconference/Webcast participation is 
limited so early registration is recommended.
     In Person: The address for this meeting is 5600 Fishers 
Lane, 5th (Main) Floor Pavilion rooms, Rockville, Maryland 20852. The 
building is a federal facility; prior registration, a security 
screening and a federally-approved identification (e.g., driver's 
license) are required to attend in-person. Capacity for in-person 
attendance is limited so early registration is recommended.
    Registration: Registration is required for participation in the 
listening session in person or via Teleconference/Webcast. Registration 
is now open. Registration for the in-person session will close on 01/
22/2018 at 12:00 p.m. Eastern Time (ET). Registration for the 
Teleconference/Webcast will close on 01/31/2018 at 8:30 a.m. ET. 
Persons registering should indicate if they wish to make a public 
comment. SAMHSA recommends that when commenters suggest changes or 
revisions to current regulations that they indicate specifically, when 
feasible, how such regulation text should be revised. Only one 
representative of an organization may be allowed to present oral 
comments. Presentations will be limited to three minutes per speaker. 
SAMHSA will try to accommodate all speakers who wish to present based 
on the time allotted for this meeting. Persons making oral 
presentations are encouraged to also submit written comments as 
discussed below.
    To register, go to: https://42-cfr-part2-listening-session.eventbrite.com.
    Special Assistance: Individuals who plan to attend and need special 
assistance, such as sign language interpretation or other reasonable 
accommodations, should notify Rachel Karton (contact information 
provided below) at least 10 days prior to the meeting.
    Public Comments: In addition to attending the session in person or 
joining via Teleconference/Webcast, the Agency offers several ways to 
provide comments. SAMHSA recommends that when commenters suggest 
changes or revisions to current regulations that they indicate 
specifically, when feasible, how such regulation text should be 
revised. You may provide comments through the following means:
     Electronically: [email protected] 
(preferred).
     Regular, Express or Overnight Mail, or Hand Delivery or 
Courier: Written comments must be sent to the following address ONLY: 
Substance Abuse and Mental Health Services Administration (SAMHSA), 
Department of Health and

[[Page 1042]]

Human Services, Attn: Mitchell Berger, SAMHSA, 5600 Fishers Lane, Room 
18E89C, Rockville, Maryland 20852. Due to the anticipated high volume 
of comments, please note that receipt of comments will not be 
acknowledged. Comments must be received by 5:00 p.m. ET on Wednesday 
February 28, 2018.
    Background: Title 42, section 290dd-2, of the United States Code, 
pertaining to Confidentiality of Records, provides that ``[r]ecords of 
the identity, diagnosis, prognosis, or treatment of any patient which 
are maintained in connection with the performance of any program or 
activity relating to substance abuse education, prevention, training, 
treatment, rehabilitation, or research, which is conducted, regulated, 
or directly or indirectly assisted by any department or agency of the 
United States shall [. . .] be confidential and be disclosed only for 
the purposes and under the circumstances expressly authorized'' by the 
statute or as otherwise provided. The statute further provides that 
such records may not be ``used to initiate or substantiate any criminal 
charges against a patient or to conduct any investigation of a 
patient'' without an appropriate court order.
    The implementing regulations, 42 CFR part 2, were first promulgated 
as a final rule on July 1, 1975 (40 FR 27802), and substantively 
updated in 1987 (52 FR 21796). On February 9, 2016, SAMHSA issued a 
notice of proposed rulemaking (NPRM) regarding substantive changes to 
part 2 (81 FR 6987) and on January 18, 2017, SAMHSA finalized changes 
to these regulations (82 FR 6052). The January 2017 final rule became 
effective on March 21, 2017 (see 82 FR 10863, Feb. 16, 2017). This 
final rule was intended to ``ensure that patients with substance use 
disorders have the ability to participate in and benefit from health 
system delivery improvements, including from new integrated health care 
models while providing appropriate privacy safeguards.'' The final rule 
made substantive changes to regulatory provisions regarding Definitions 
(Sec.  2.11), Applicability (Sec.  2.12), Confidentiality restrictions 
and safeguards (Sec.  2.13), Security for records (Sec.  2.16), 
Disposition of records by discontinued programs (Sec.  2.19), Consent 
requirements (Sec.  2.31), Re-disclosure (Sec.  2.32), Medical 
emergencies (Sec.  2.51), Research (Sec.  2.52), and Audit and 
evaluation (Sec.  2.53).
    Concurrently with finalizing these changes, SAMHSA issued a 
supplemental notice of proposed rulemaking (SNPRM) on January 18, 2017, 
proposing additional changes to facilitate disclosures by lawful 
holders to their contractors, subcontractors, and legal representative 
for the purposes of payment and health care operations and for carrying 
out an audit or evaluation and to permit disclosures by lawful holders 
to those conducting audits and evaluations on behalf of a governmental 
agency providing financial assistance to or regulatory oversight over 
the lawful holder. SAMHSA also sought comments on other topics, 
including an option for an abbreviated prohibition on re-disclosure 
notice. In January 2018, SAMHSA published a final rule implementing 
these changes.
    In response to the 2016 NPRM and since publication of the January 
2017 final rule and the SNPRM, SAMHSA has already heard from numerous 
stakeholders on a range of issues pertaining to part 2. For instance, 
some commenters asserted that part 2 has become a barrier to 
integration of care and research. Many commenters also have suggested 
that part 2 does not adequately align with the Health Insurance 
Portability and Accountability Act (HIPAA). SAMHSA also has received 
many comments emphasizing the continuing importance of part 2 in 
protecting patients who seek substance use disorder treatment from 
discrimination in housing, employment, education, and other settings as 
well as from criminal investigation and penalties. Some commenters also 
have urged SAMHSA to update part 2 penalty provisions and prevent what 
they believe to be misuse of patient identifying information.
    On December 13, 2016, the 21st Century Cures Act was signed into 
law (Pub. L. 114-255). Section 11002 of this law requires that, within 
one year of the effective date of the final rule, ``the Secretary [HHS] 
shall convene relevant stakeholders to determine the effect of such 
regulations on patient care, health outcomes, and patient privacy.'' 
The listening session on January 31, 2018, will solicit input focused 
on how part 2 impacts patient care, health outcomes and patient privacy 
as well as potential regulatory changes and future subregulatory 
guidance. It is important to note that any recommendations of further 
changes to part 2 received during this meeting could, even if legally 
permissible and feasible, only be implemented after notice-and-comment 
as required by the Administrative Procedures Act.
* * * * *

    Dated: January 3, 2017.
Charles LoDico,
Chemist.
[FR Doc. 2018-00150 Filed 1-8-18; 8:45 am]
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