83_FR_22360 83 FR 22267 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

83 FR 22267 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 83, Issue 93 (May 14, 2018)

Page Range22267-22268
FR Document2018-10130

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Federal Register, Volume 83 Issue 93 (Monday, May 14, 2018)
[Federal Register Volume 83, Number 93 (Monday, May 14, 2018)]
[Notices]
[Pages 22267-22268]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10130]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10307]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

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

SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate or any other aspect of this 
collection of information, including the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected and the use of automated collection techniques or other forms 
of information technology to minimize the information collection 
burden.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by June 22, 2018.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-5806 OR Email: 
[email protected].
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' website address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. The term ``collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension or reinstatement of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, CMS is publishing this notice that 
summarizes the following proposed collection(s) of information for 
public comment:

[[Page 22268]]

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medical Necessity 
and Claims Denial Disclosures under MHPAEA; Use: The Paul Wellstone and 
Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 
(MHPAEA) (Pub. L. 110-343) generally requires that group health plans 
and group health insurance issuers offering mental health or substance 
use disorder (MH/SUD) benefits in addition to medical and surgical 
(med/surg) benefits ensure that they do not apply any more restrictive 
financial requirements (e.g., co-pays, deductibles) and/or treatment 
limitations (e.g., visit limits) to MH/SUD benefits than those 
requirements and/or limitations applied to substantially all med/surg 
benefits.
    The Patient Protection and Affordable Care Act, Public Law 111-148, 
was enacted on March 23, 2010, and the Health Care and Education 
Reconciliation Act of 2010, Public Law 111-152, was enacted on March 
30, 2010. These statutes are collectively known as the ``Affordable 
Care Act.'' The Affordable Care Act extended MHPAEA to apply to the 
individual health insurance market. Additionally, the Department of 
Health and Human Services (HHS) final regulation regarding essential 
health benefits (EHB) requires health insurance issuers offering non-
grandfathered health insurance coverage in the individual and small 
group markets, through an Exchange or outside of an Exchange, to comply 
with the requirements of the MHPAEA regulations in order to satisfy the 
requirement to cover EHB (45 CFR 147.150 and 156.115).

Medical Necessity Disclosure Under MHPAEA

    MHPAEA section 512(b) specifically amends the Public Health Service 
(PHS) Act to require plan administrators or health insurance issuers to 
provide, upon request, the criteria for medical necessity 
determinations made with respect to MH/SUD benefits to current or 
potential participants, beneficiaries, or contracting providers. The 
Interim Final Rules Under the Paul Wellstone and Pete Domenici Mental 
Health Parity and Addiction Equity Act of 2008 (75 FR 5410, February 2, 
2010) and the Final Rules under the Paul Wellstone and Pete Domenici 
Mental Health Parity and Addiction Equity Act of 2008 set forth rules 
for providing criteria for medical necessity determinations. CMS 
administers MHPAEA with respect to non-Federal governmental plans and 
health insurance issuers.

Claims Denial Disclosure Under MHPAEA

    MHPAEA section 512(b) specifically amends the PHS Act to require 
plan administrators or health insurance issuers to provide, upon 
request, the reason for any denial or reimbursement of payment for MH/
SUD services to the participant or beneficiary involved in the case. 
The Interim Final Rules Under the Paul Wellstone and Pete Domenici 
Mental Health Parity and Addiction Equity Act of 2008 (75 FR 5410, 
February 2, 2010) and the Final Rules under the Paul Wellstone and Pete 
Domenici Mental Health Parity and Addiction Equity Act of 2008 
implement 45 CFR 146.136(d)(2), which sets forth rules for providing 
reasons for claims denial. CMS administers MHPAEA with respect to non-
Federal governmental plans and health insurance issuers, and the 
regulation provides a safe harbor such that non-Federal governmental 
plans (and issuers offering coverage in connection with such plans) are 
deemed to comply with requirements of paragraph (d)(2) of 45 CFR 
146.136 if they provide the reason for claims denial in a form and 
manner consistent with ERISA requirements found in 29 CFR 2560.503-1. 
Section 146.136(d)(3) of the final rule clarifies that PHS Act section 
2719 governing internal claims and appeals and external review as 
implemented by 45 CFR 147.136, covers MHPAEA claims denials and 
requires that, when a non-quantitative treatment limitation (NQTL) is 
the basis for a claims denial, that a non-grandfathered plan or issuer 
must provide the processes, strategies, evidentiary standard, and other 
factors used in developing and applying the NQTL with respect to med/
surg benefits and MH/SUD benefits.

Disclosure Request Form

    Group health plan participants, beneficiaries, covered individuals 
in the individual market, or persons acting on their behalf, may use 
this optional model form to request information from plans regarding 
NQTLs that may affect patients' MH/SUD benefits or that may have 
resulted in their coverage being denied. Form Number: CMS-10307 (OMB 
control number: 0938-1080); Frequency: On Occasion; Affected Public: 
State, Local, or Tribal Governments, Private Sector, Individuals; 
Number of Respondents: 267,538; Total Annual Responses: 1,081,929; 
Total Annual Hours: 43,327. (For policy questions regarding this 
collection contact Usree Bandyopadhyay at 410-786-6650.)

    Dated: May 8, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-10130 Filed 5-11-18; 8:45 am]
 BILLING CODE 4120-01-P



                                                                             Federal Register / Vol. 83, No. 93 / Monday, May 14, 2018 / Notices                                            22267

                                             information to be collected, and the use                approved collection; Title of                         collection for the proper performance of
                                             of automated collection techniques or                   Information Collection: Survey Report                 the agency’s functions, the accuracy of
                                             other forms of information technology to                Form for Clinical Laboratory                          the estimated burden, ways to enhance
                                             minimize the information collection                     Improvement Amendments (CLIA) and                     the quality, utility, and clarity of the
                                             burden.                                                 Supporting Regulations; Use: The form                 information to be collected and the use
                                                                                                     is used to report surveyor findings                   of automated collection techniques or
                                             DATES:  Comments on the collection(s) of
                                                                                                     during a CLIA survey. For each type of                other forms of information technology to
                                             information must be received by the
                                                                                                     survey conducted (i.e., initial                       minimize the information collection
                                             OMB desk officer by June 13, 2018.
                                                                                                     certification, recertification, validation,           burden.
                                             ADDRESSES: When commenting on the                       complaint, addition/deletion of
                                             proposed information collections,                                                                             DATES: Comments on the collection(s) of
                                                                                                     specialty/subspecialty, transfusion
                                             please reference the document identifier                                                                      information must be received by the
                                                                                                     fatality investigation, or revisit
                                             or OMB control number. To be assured                                                                          OMB desk officer by June 22, 2018.
                                                                                                     inspections) the Survey Report Form
                                             consideration, comments and                             incorporates the requirements specified               ADDRESSES: When commenting on the
                                             recommendations must be received by                     in the CLIA regulations. Form Number:                 proposed information collections,
                                             the OMB desk officer via one of the                     CMS–1557 (OMB control number:                         please reference the document identifier
                                             following transmissions: OMB, Office of                 0938–0544); Frequency: Biennially;                    or OMB control number. To be assured
                                             Information and Regulatory Affairs;                     Affected Public: Private sector (Business             consideration, comments and
                                             Attention: CMS Desk Officer; Fax                        or other for-profit and Not-for-profit                recommendations must be received by
                                             Number: (202) 395–5806 OR Email:                        institutions, State, Local or Tribal                  the OMB desk officer via one of the
                                             OIRA_submission@omb.eop.gov.                            Governments and Federal Government);                  following transmissions: OMB, Office of
                                               To obtain copies of a supporting                      Number of Respondents: 19,183; Total                  Information and Regulatory Affairs,
                                             statement and any related forms for the                 Annual Responses: 9,592; Total Annual                 Attention: CMS Desk Officer, Fax
                                             proposed collection(s) summarized in                    Hours: 4,796. (For policy questions                   Number: (202) 395–5806 OR Email:
                                             this notice, you may make your request                  regarding this collection contact                     OIRA_submission@omb.eop.gov.
                                             using one of following:                                 Kathleen Todd at 410–786–3385).                         To obtain copies of a supporting
                                               1. Access CMS’ website address at                        Dated: May 8, 2018.
                                                                                                                                                           statement and any related forms for the
                                             website address at https://www.cms.gov/                                                                       proposed collection(s) summarized in
                                                                                                     William N. Parham, III,
                                             Regulations-and-Guidance/Legislation/                                                                         this notice, you may make your request
                                                                                                     Director, Paperwork Reduction Staff, Office
                                             PaperworkReductionActof1995/PRA-                                                                              using one of following:
                                                                                                     of Strategic Operations and Regulatory
                                             Listing.html.                                           Affairs.                                                1. Access CMS’ website address at
                                               1. Email your request, including your                                                                       http://www.cms.hhs.gov/
                                                                                                     [FR Doc. 2018–10135 Filed 5–11–18; 8:45 am]
                                             address, phone number, OMB number,                                                                            PaperworkReductionActof1995.
                                                                                                     BILLING CODE 4120–01–P
                                             and CMS document identifier, to                                                                                 2. Email your request, including your
                                             Paperwork@cms.hhs.gov.                                                                                        address, phone number, OMB number,
                                               2. Call the Reports Clearance Office at               DEPARTMENT OF HEALTH AND                              and CMS document identifier, to
                                             (410) 786–1326.                                         HUMAN SERVICES                                        Paperwork@cms.hhs.gov.
                                             FOR FURTHER INFORMATION CONTACT:                                                                                3. Call the Reports Clearance Office at
                                             Reports Clearance Office at (410) 786–                  Centers for Medicare & Medicaid                       (410) 786–1326.
                                             1326.                                                   Services                                              FOR FURTHER INFORMATION CONTACT:
                                             SUPPLEMENTARY INFORMATION:     Under the                [Document Identifier: CMS–10307]                      Reports Clearance Office at (410) 786–
                                             Paperwork Reduction Act of 1995 (PRA)                                                                         1326.
                                             (44 U.S.C. 3501–3520), federal agencies                 Agency Information Collection                         SUPPLEMENTARY INFORMATION:     Under the
                                             must obtain approval from the Office of                 Activities: Submission for OMB                        Paperwork Reduction Act of 1995 (PRA)
                                             Management and Budget (OMB) for each                    Review; Comment Request                               (44 U.S.C. 3501–3520), federal agencies
                                             collection of information they conduct                  AGENCY: Centers for Medicare &                        must obtain approval from the Office of
                                             or sponsor. The term ‘‘collection of                    Medicaid Services, HHS.                               Management and Budget (OMB) for each
                                             information’’ is defined in 44 U.S.C.                   ACTION: Notice.                                       collection of information they conduct
                                             3502(3) and 5 CFR 1320.3(c) and                                                                               or sponsor. The term ‘‘collection of
                                             includes agency requests or                             SUMMARY:    The Centers for Medicare &                information’’ is defined in 44 U.S.C.
                                             requirements that members of the public                 Medicaid Services (CMS) is announcing                 3502(3) and 5 CFR 1320.3(c) and
                                             submit reports, keep records, or provide                an opportunity for the public to                      includes agency requests or
                                             information to a third party. Section                   comment on CMS’ intention to collect                  requirements that members of the public
                                             3506(c)(2)(A) of the PRA (44 U.S.C.                     information from the public. Under the                submit reports, keep records, or provide
                                             3506(c)(2)(A)) requires federal agencies                Paperwork Reduction Act of 1995                       information to a third party. Section
                                             to publish a 30-day notice in the                       (PRA), federal agencies are required to               3506(c)(2)(A) of the PRA (44 U.S.C.
                                             Federal Register concerning each                        publish notice in the Federal Register                3506(c)(2)(A)) requires federal agencies
                                             proposed collection of information,                     concerning each proposed collection of                to publish a 30-day notice in the
                                             including each proposed extension or                    information, including each proposed                  Federal Register concerning each
                                             reinstatement of an existing collection                 extension or reinstatement of an existing             proposed collection of information,
                                             of information, before submitting the                   collection of information, and to allow               including each proposed extension or
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                                             collection to OMB for approval. To                      a second opportunity for public                       reinstatement of an existing collection
                                             comply with this requirement, CMS is                    comment on the notice. Interested                     of information, before submitting the
                                             publishing this notice that summarizes                  persons are invited to send comments                  collection to OMB for approval. To
                                             the following proposed collection(s) of                 regarding the burden estimate or any                  comply with this requirement, CMS is
                                             information for public comment:                         other aspect of this collection of                    publishing this notice that summarizes
                                               1. Type of Information Collection                     information, including the necessity and              the following proposed collection(s) of
                                             Request: Revision of a currently                        utility of the proposed information                   information for public comment:


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                                             22268                           Federal Register / Vol. 83, No. 93 / Monday, May 14, 2018 / Notices

                                                1. Type of Information Collection                    Claims Denial Disclosure Under                           Dated: May 8, 2018.
                                             Request: Revision of a currently                        MHPAEA                                                William N. Parham, III,
                                             approved collection; Title of                                                                                 Director, Paperwork Reduction Staff, Office
                                             Information Collection: Medical                            MHPAEA section 512(b) specifically                 of Strategic Operations and Regulatory
                                             Necessity and Claims Denial Disclosures                 amends the PHS Act to require plan                    Affairs.
                                             under MHPAEA; Use: The Paul                             administrators or health insurance                    [FR Doc. 2018–10130 Filed 5–11–18; 8:45 am]
                                             Wellstone and Pete Domenici Mental                      issuers to provide, upon request, the                 BILLING CODE 4120–01–P
                                             Health Parity and Addiction Equity Act                  reason for any denial or reimbursement
                                             of 2008 (MHPAEA) (Pub. L. 110–343)                      of payment for MH/SUD services to the
                                             generally requires that group health                    participant or beneficiary involved in                DEPARTMENT OF HEALTH AND
                                             plans and group health insurance                        the case. The Interim Final Rules Under               HUMAN SERVICES
                                             issuers offering mental health or                       the Paul Wellstone and Pete Domenici
                                             substance use disorder (MH/SUD)                         Mental Health Parity and Addiction                    Administration for Children and
                                             benefits in addition to medical and                     Equity Act of 2008 (75 FR 5410,                       Families
                                             surgical (med/surg) benefits ensure that                February 2, 2010) and the Final Rules
                                                                                                                                                           Submission for OMB Review;
                                             they do not apply any more restrictive                  under the Paul Wellstone and Pete
                                                                                                                                                           Comment Request
                                             financial requirements (e.g., co-pays,                  Domenici Mental Health Parity and
                                             deductibles) and/or treatment                           Addiction Equity Act of 2008                             Title: Implementation Grants to
                                             limitations (e.g., visit limits) to MH/SUD              implement 45 CFR 146.136(d)(2), which                 Develop a Model Intervention for
                                             benefits than those requirements and/or                 sets forth rules for providing reasons for            Youth/Young Adults with Child Welfare
                                             limitations applied to substantially all                claims denial. CMS administers                        Involvement at Risk of Homelessness:
                                             med/surg benefits.                                      MHPAEA with respect to non-Federal                    Phase II—Extension.
                                                The Patient Protection and Affordable                governmental plans and health                            OMB NO.: 0970–0445.
                                             Care Act, Public Law 111–148, was                       insurance issuers, and the regulation                    Description: The Administration for
                                             enacted on March 23, 2010, and the                      provides a safe harbor such that non-                 Children and Families (ACF) at the U.S.
                                             Health Care and Education                               Federal governmental plans (and issuers               Department of Health and Human
                                             Reconciliation Act of 2010, Public Law                  offering coverage in connection with                  Services (HHS) intends to collect data
                                             111–152, was enacted on March 30,                       such plans) are deemed to comply with                 for an evaluation of the initiative,
                                             2010. These statutes are collectively                   requirements of paragraph (d)(2) of 45                Implementation Grants to Develop a
                                             known as the ‘‘Affordable Care Act.’’                   CFR 146.136 if they provide the reason                Model Intervention for Youth/Young
                                             The Affordable Care Act extended                        for claims denial in a form and manner                Adults with Child Welfare Involvement
                                             MHPAEA to apply to the individual                       consistent with ERISA requirements                    at Risk of Homelessness: Phase II. This
                                             health insurance market. Additionally,                  found in 29 CFR 2560.503–1. Section                   builds on the previously approved
                                             the Department of Health and Human                      146.136(d)(3) of the final rule clarifies             ‘‘Planning Grants to Develop a Model
                                             Services (HHS) final regulation                         that PHS Act section 2719 governing                   Intervention for Youth/Young Adults
                                             regarding essential health benefits (EHB)               internal claims and appeals and external              with Child Welfare Involvement at Risk
                                             requires health insurance issuers                       review as implemented by 45 CFR                       of Homelessness’’ (Phase I). The Phase
                                             offering non-grandfathered health                       147.136, covers MHPAEA claims                         II data collection described in this
                                             insurance coverage in the individual                    denials and requires that, when a non-                Notice was approved by the Office of
                                             and small group markets, through an                     quantitative treatment limitation                     Management and Budget in July 2017.
                                             Exchange or outside of an Exchange, to                  (NQTL) is the basis for a claims denial,              This request is for a time extension for
                                             comply with the requirements of the                     that a non-grandfathered plan or issuer               data collection under OMB# 0970–0445.
                                             MHPAEA regulations in order to satisfy                  must provide the processes, strategies,               There are no changes to the previously
                                             the requirement to cover EHB (45 CFR                    evidentiary standard, and other factors               approved information collection. Due to
                                             147.150 and 156.115).                                   used in developing and applying the                   delays, data collection has not begun
                                                                                                     NQTL with respect to med/surg benefits                and will need to extend beyond the
                                             Medical Necessity Disclosure Under
                                                                                                     and MH/SUD benefits.                                  current expiration date of July 2018.
                                             MHPAEA
                                                                                                                                                           Grantees are receiving an additional
                                               MHPAEA section 512(b) specifically                    Disclosure Request Form                               year to conduct their work. To capture
                                             amends the Public Health Service (PHS)                                                                        data at a similar point in the
                                             Act to require plan administrators or                     Group health plan participants,                     development of their efforts, data
                                             health insurance issuers to provide,                    beneficiaries, covered individuals in the             collection will be delayed.
                                             upon request, the criteria for medical                  individual market, or persons acting on                  Phase II is an initiative, funded by the
                                             necessity determinations made with                      their behalf, may use this optional                   Children’s Bureau (CB) within ACF, that
                                             respect to MH/SUD benefits to current                   model form to request information from                will support implementation grants for
                                             or potential participants, beneficiaries,               plans regarding NQTLs that may affect                 interventions designed to intervene with
                                             or contracting providers. The Interim                   patients’ MH/SUD benefits or that may                 youth who have experienced time in
                                             Final Rules Under the Paul Wellstone                    have resulted in their coverage being                 foster care and are most likely to have
                                             and Pete Domenici Mental Health Parity                  denied. Form Number: CMS–10307                        a challenging transition into adulthood,
                                             and Addiction Equity Act of 2008 (75                    (OMB control number: 0938–1080);                      including homelessness and unstable
                                             FR 5410, February 2, 2010) and the                      Frequency: On Occasion; Affected                      housing experiences. CB awarded six
                                             Final Rules under the Paul Wellstone                    Public: State, Local, or Tribal                       implementation grants (Phase II) in
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                                             and Pete Domenici Mental Health Parity                  Governments, Private Sector,                          September 2015. During the
                                             and Addiction Equity Act of 2008 set                    Individuals; Number of Respondents:                   implementation phase, organizations
                                             forth rules for providing criteria for                  267,538; Total Annual Responses:                      will conduct a range of activities to fine-
                                             medical necessity determinations. CMS                   1,081,929; Total Annual Hours: 43,327.                tune their comprehensive service
                                             administers MHPAEA with respect to                      (For policy questions regarding this                  model, determine whether their model
                                             non-Federal governmental plans and                      collection contact Usree                              is being implemented as intended, and
                                             health insurance issuers.                               Bandyopadhyay at 410–786–6650.)                       develop plans to evaluate the model


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Document Created: 2018-05-12 01:11:13
Document Modified: 2018-05-12 01:11:13
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on the collection(s) of information must be received by the OMB desk officer by June 22, 2018.
ContactReports Clearance Office at (410) 786- 1326.
FR Citation83 FR 22267 

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