Confidentiality of Substance Use Disorder Patient Records, 1041-1042 [2018-00150]

Download as PDF Federal Register / Vol. 83, No. 6 / Tuesday, January 9, 2018 / Notices National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, MD 20892, 301–594–4805, adombroski@nidcr.nih.gov. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: https:// www.nidcr.nih.gov/about, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.121, Oral Diseases and Disorders Research, National Institutes of Health, HHS) Dated: January 2, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–00155 Filed 1–8–18; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting sradovich on DSK3GMQ082PROD with NOTICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the meeting of the National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel; MSM Program Review (2018/05). Date: February 12, 2018. Time: 5:00 p.m. to 12:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Plaza, Suite 920, Bethesda, MD 20892 (Virtual Meeting). 15:58 Jan 08, 2018 Dated: January 2, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–00154 Filed 1–8–18; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Confidentiality of Substance Use Disorder Patient Records Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice of public meeting. AGENCY: 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 PrivacyRegulations@ SAMHSA.hhs.gov. 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 SUMMARY: BILLING CODE 4140–01–P VerDate Sep<11>2014 Contact Person: Manana Sukhareva, Ph.D., Scientific Review Officer, National Institutes of Biomedical Imaging and Bioengineering, National Institutes of Health, 6707 Democracy Boulevard, Suite 959, Bethesda, MD 20892, (301) 451–3397, sukharem@ mail.nih.gov. Jkt 244001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 1041 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 federallyapproved 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-part2listening-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: PrivacyRegulations@ SAMHSA.hhs.gov (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 E:\FR\FM\09JAN1.SGM 09JAN1 sradovich on DSK3GMQ082PROD with NOTICES 1042 Federal Register / Vol. 83, No. 6 / Tuesday, January 9, 2018 / Notices 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 (§ 2.11), Applicability (§ 2.12), Confidentiality restrictions and safeguards (§ 2.13), Security for records (§ 2.16), Disposition of records by discontinued programs (§ 2.19), Consent requirements (§ 2.31), Re-disclosure (§ 2.32), Medical emergencies (§ 2.51), Research (§ 2.52), and Audit and evaluation (§ 2.53). Concurrently with finalizing these changes, SAMHSA issued a supplemental notice of proposed rulemaking (SNPRM) on January 18, 2017, proposing additional changes to VerDate Sep<11>2014 15:58 Jan 08, 2018 Jkt 244001 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 redisclosure 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. * * * * * PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Dated: January 3, 2017. Charles LoDico, Chemist. [FR Doc. 2018–00150 Filed 1–8–18; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Mental Health Services: Notice of Meeting Pursuant to Public Law 92–463, notice is hereby given that the Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services (CMHS) National Advisory Council (NAC) will meet on February 14, 2018, from 8:30 a.m. to 5:00 p.m. E.D.T. The CMHS NAC will convene in both open and closed sessions on February 14, 2018. The closed portion of the meeting will include discussion and evaluation of grant applications reviewed by SAMHSA’s Initial Review Groups, and involve an examination of confidential financial and business information as well as personal information concerning the applicants. Therefore, the meeting will be closed to the public from 8:30 a.m. to 10:00 a.m. as determined by the Assistant Secretary for Mental Health and Substance Use, SAMHSA in accordance with Title 5 U.S.C. 552b(c)(4) and (6) and Title 5 U.S.C. App. 2, 10(d). The remainder of this meeting will be open to the public from 10:00 a.m. to 5:00 p.m., E.D.T., to include discussion of the Center’s policy issues, presentations on SAMHSA’s Policy Lab, Disaster Responses and a conversation with the Assistant Secretary for Mental Health and Substance Use. Attendance by the public will be limited to available space. Interested persons may present data, information, or views, orally or in writing, on issues pending before the council. Written submissions should be forwarded to the contact person (below) on or before January 31, 2018. Oral presentations from the public will be scheduled at the conclusion of the meeting on Wednesday, February 14, 2018. Five minutes will be allotted for each presentation. Meeting information and a roster of Council members may be obtained either by accessing the SAMHSA Council website at https:// www.samhsa.gov/about-us/advisorycouncils/cmhs-national-advisory- E:\FR\FM\09JAN1.SGM 09JAN1

Agencies

[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.

-----------------------------------------------------------------------

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]
 BILLING CODE P