83_FR_61869 83 FR 61638 - Agency Information Collection Activities: Proposed Collection; Comment Request

83 FR 61638 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 83, Issue 231 (November 30, 2018)

Page Range61638-61639
FR Document2018-26052

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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 231 (Friday, November 30, 2018)
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61638-61639]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26052]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10691]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Department of Health 
and Human Services.

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 (the 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 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates 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 must be received by January 29, 2019.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following

[[Page 61639]]

address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    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 website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    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: William Parham at (410) 786-1326.

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-10691 Data Request and Attestation for PDP Sponsors

    Under the 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 requires federal agencies 
to publish a 60-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.

Information Collection

    Type of Information Collection Request: New collection (request for 
a new OMB control number); Title of Information Collection: Data 
Request and Attestation for PDP Sponsors; Use: Section 50354 of the 
Bipartisan Budget Act of 2018 (BBA) provides that the Secretary shall 
establish a process under which the sponsor of a Prescription Drug Plan 
(PDP) that provide prescription drug benefits under Medicare Part D may 
request, beginning in plan year 2020, that the Secretary provide on a 
periodic basis and in an electronic format standardized extracts of 
Medicare claims about its plan enrollees. Section 50354 of the BBA 
further specifies that PDP sponsors receiving such Medicare claims data 
for their corresponding PDP plan enrollees may use the data for: (1) 
Optimizing therapeutic outcomes through improved medication use, (2) 
improving care coordination so as to prevent adverse healthcare 
outcomes, such as preventable emergency department visits and hospital 
readmissions, and (3) for any other purposes determined appropriate by 
the Secretary. Section 50354 also states that the PDP sponsor may not 
use the data: (1) To inform coverage determinations under Part D, (2) 
to conduct retroactive review of medically accepted conditions, (3) to 
facilitate enrollment changes to a different PDP or a MA-PD plan 
offered by the same parent organization, (4) to inform marketing 
benefits; and (5) for any other purpose the Secretary determines is 
necessary to include in order to protect the identity of individuals 
entitled to or enrolled in Medicare, and to protect the security of 
personal health information. This proposed information collection 
request would allow the PDP sponsor to submit a request to CMS for 
claims data for its enrollees and to attest that it will adhere to the 
permitted uses and limitations on the use of the Medicare claims data 
that are listed in 42 CFR 423.153. Form Number: CMS-10691 (OMB control 
number: 0938-TBD); Frequency: Occasionally; Affected Public: Private 
sector; Number of Respondents: 63; Total Annual Responses: 68; Total 
Annual Hours: 1.36. (For policy questions regarding this collection 
contact Kari Gaare at 410-786-8612.)

    Dated: November 27, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-26052 Filed 11-29-18; 8:45 am]
 BILLING CODE 4120-01-P



                                              61638                       Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices

                                              and purchase of services to provide                     have strong and effective corporate                     Board of Governors of the Federal Reserve
                                              information.                                            governance to help ensure sound                       System, November 27, 2018.
                                                At the end of the comment period, the                 compensation practices. The Guidance                  Michele Taylor Fennell,
                                              comments and recommendations                            states that a banking organization’s                  Assistant Secretary of the Board.
                                              received will be analyzed to determine                  board of directors should approve and                 [FR Doc. 2018–26088 Filed 11–29–18; 8:45 am]
                                              the extent to which the Board should                    document any material exceptions or                   BILLING CODE 6210–01–P
                                              modify the proposal.                                    adjustments to the organization’s
                                              Proposal Under OMB Delegated                            incentive compensation arrangements
                                              Authority To Extend for Three Years,                    established for senior executives.                    DEPARTMENT OF HEALTH AND
                                              Without Revision, the Following                                                                               HUMAN SERVICES
                                                                                                         Legal authorization and
                                              Information Collection                                  confidentiality: The recordkeeping                    Centers for Medicare & Medicaid
                                                Report title: Recordkeeping Provisions                provisions of the Guidance are                        Services
                                              Associated with the Guidance on Sound                   authorized pursuant to sections 9, 11(a),
                                              Incentive Compensation Policies.                                                                              [Document Identifier CMS–10691]
                                                                                                      25, and 25A of the Federal Reserve Act
                                                Agency form number: FR 4027.                          (12 U.S.C. 248(a), 325, 602, and 625);
                                                OMB control number: 7100–0327.                                                                              Agency Information Collection
                                                                                                      section 5 of the Bank Holding Company                 Activities: Proposed Collection;
                                                Frequency: Annual.
                                                Respondents: Banking organizations.                   Act (12 U.S.C. 1844); section 10(b)(2) of             Comment Request
                                                Estimated number of respondents:                      the Home Owners’ Loan Act (12 U.S.C.
                                                                                                      1467a(b)(2)); section 7(c) of the                     AGENCY: Centers for Medicare &
                                              One-time implementation for large
                                                                                                      International Banking Act (12 U.S.C.                  Medicaid Services, Department of
                                              institutions: 1; one-time implementation
                                                                                                      3105(c)); and section 39 of the Federal               Health and Human Services.
                                              for small institutions: 1; ongoing
                                                                                                      Deposit Insurance Act (12 U.S.C.                      ACTION: Notice.
                                              maintenance: 5,503.
                                                Estimated average hours per response:                 1831p–1(c)).                                          SUMMARY:    The Centers for Medicare &
                                              One-time implementation for large                          Because the recordkeeping provisions               Medicaid Services (CMS) is announcing
                                              institutions: 480; one-time                             are contained within guidance, which is               an opportunity for the public to
                                              implementation for small institutions:                                                                        comment on CMS’ intention to collect
                                                                                                      nonbinding, they are voluntary. There
                                              80; ongoing maintenance: 40.                                                                                  information from the public. Under the
                                                Estimated annual burden hours:                        are no reporting forms associated with
                                                                                                      this information collection.                          Paperwork Reduction Act of 1995 (the
                                              228,960.                                                                                                      PRA), federal agencies are required to
                                                General description of report:                           Because the incentive compensation                 publish notice in the Federal Register
                                              Compatibility With Effective Controls                   records would be maintained at each                   concerning each proposed collection of
                                              and Risk Management                                     banking organization, the Freedom of                  information (including each proposed
                                                                                                      Information Act (‘‘FOIA’’) would only                 extension or reinstatement of an existing
                                                Pursuant to Principle 2 of the
                                                                                                      be implicated if the Board obtained such              collection of information) and to allow
                                              Guidance, a banking organization’s risk-
                                                                                                      records as part of the examination or                 60 days for public comment on the
                                              management processes and internal
                                              controls should reinforce and support                   supervision of a banking organization.                proposed action. Interested persons are
                                              the development and maintenance of                      In the event the records are obtained by              invited to send comments regarding our
                                              balanced incentive compensation                         the Board as part of an examination or                burden estimates or any other aspect of
                                              arrangements. Principle 2 states that                   supervision of a financial institution,               this collection of information, including
                                              banking organizations should create and                 this information is considered                        the necessity and utility of the proposed
                                              maintain sufficient documentation to                    confidential pursuant to exemption 8 of               information collection for the proper
                                              permit an audit of the organization’s                   the FOIA, which protects information                  performance of the agency’s functions,
                                              processes for establishing, modifying,                  contained in ‘‘examination, operating,                the accuracy of the estimated burden,
                                              and monitoring incentive compensation                   or condition reports’’ obtained in the                ways to enhance the quality, utility, and
                                              arrangements. Additionally, large                       bank supervisory process (5 U.S.C.                    clarity of the information to be
                                              banking organizations should maintain                   552(b)(8)). In addition, the information              collected, and the use of automated
                                              policies and procedures that (i) identify                                                                     collection techniques or other forms of
                                                                                                      may also be kept confidential under
                                              and describe the role(s) of the                                                                               information technology to minimize the
                                                                                                      exemption 4 for the FOIA, which                       information collection burden.
                                              personnel, business units, and control                  protects commercial or financial
                                              units authorized to be involved in the                                                                        DATES: Comments must be received by
                                                                                                      information obtained from a person that
                                              design, implementation, and monitoring                                                                        January 29, 2019.
                                                                                                      is privileged or confidential (5 U.S.C.
                                              of incentive compensation                                                                                     ADDRESSES: When commenting, please
                                                                                                      552(b)(4)).
                                              arrangements; (ii) identify the source of                                                                     reference the document identifier or
                                              significant risk-related inputs into these                 Consultation outside the agency: The               OMB control number. To be assured
                                              processes and establish appropriate                     Board has consulted with the OCC and                  consideration, comments and
                                              controls governing the development and                  FDIC to confirm that there will be no                 recommendations must be submitted in
                                              approval of these inputs to help ensure                 revisions to the Guidance, and that the               any one of the following ways:
                                              their integrity; and (iii) identify the                 one-time implementation burden should                   1. Electronically. You may send your
                                              individual(s) and control unit(s) whose                 be reduced, as these agencies do not                  comments electronically to http://
                                              approval is necessary for the                           expect any banking organizations to                   www.regulations.gov. Follow the
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                                              establishment of new incentive                          newly implement the recordkeeping                     instructions for ‘‘Comment or
                                              compensation arrangements or                            requirements associated with the                      Submission’’ or ‘‘More Search Options’’
                                              modification of existing arrangements.                  Guidance. Each agency may update                      to find the information collection
                                                                                                      their respective respondent count if                  document(s) that are accepting
                                              Strong Corporate Governance                                                                                   comments.
                                                                                                      needed.
                                                Pursuant to Principle 3 of the                                                                                2. By regular mail. You may mail
                                              Guidance, banking organizations should                                                                        written comments to the following


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                                                                          Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices                                          61639

                                              address: CMS, Office of Strategic                       Secretary shall establish a process under             DEPARTMENT OF HEALTH AND
                                              Operations and Regulatory Affairs,                      which the sponsor of a Prescription                   HUMAN SERVICES
                                              Division of Regulations Development,                    Drug Plan (PDP) that provide
                                              Attention: Document Identifier/OMB                      prescription drug benefits under                      Centers for Medicare & Medicaid
                                              Control Number ll, Room C4–26–05,                       Medicare Part D may request, beginning                Services
                                              7500 Security Boulevard, Baltimore,                     in plan year 2020, that the Secretary                 [CMS–3374–N]
                                              Maryland 21244–1850.                                    provide on a periodic basis and in an
                                                To obtain copies of a supporting                      electronic format standardized extracts               Medicare Program; Request for
                                              statement and any related forms for the                                                                       Nominations for Members for the
                                                                                                      of Medicare claims about its plan
                                              proposed collection(s) summarized in                                                                          Medicare Evidence Development &
                                                                                                      enrollees. Section 50354 of the BBA
                                              this notice, you may make your request                                                                        Coverage Advisory Committee
                                              using one of following:                                 further specifies that PDP sponsors
                                                1. Access CMS’ website address at                     receiving such Medicare claims data for               AGENCY: Centers for Medicare &
                                              website address at https://www.cms.gov/                 their corresponding PDP plan enrollees                Medicaid Services, HHS.
                                              Regulations-and-Guidance/Legislation/                   may use the data for: (1) Optimizing                  ACTION: Notice.
                                              PaperworkReductionActof1995/PRA-                        therapeutic outcomes through improved
                                              Listing.html.                                           medication use, (2) improving care                    SUMMARY:   This notice announces the
                                                2. Email your request, including your                 coordination so as to prevent adverse                 request for nominations for membership
                                              address, phone number, OMB number,                      healthcare outcomes, such as                          on the Medicare Evidence Development
                                              and CMS document identifier, to                         preventable emergency department                      & Coverage Advisory Committee
                                              Paperwork@cms.hhs.gov.                                  visits and hospital readmissions, and (3)             (MEDCAC). Among other duties, the
                                                3. Call the Reports Clearance Office at               for any other purposes determined                     MEDCAC provides advice and guidance
                                              (410) 786–1326.                                         appropriate by the Secretary. Section                 to the Secretary of the Department of
                                              FOR FURTHER INFORMATION CONTACT:                        50354 also states that the PDP sponsor                Health and Human Services (the
                                              William Parham at (410) 786–1326.                       may not use the data: (1) To inform                   Secretary) and the Administrator of the
                                              SUPPLEMENTARY INFORMATION:                              coverage determinations under Part D,                 Centers for Medicare & Medicaid
                                                                                                      (2) to conduct retroactive review of                  Services (CMS) concerning the
                                              Contents                                                                                                      adequacy of scientific evidence
                                                                                                      medically accepted conditions, (3) to
                                                This notice sets out a summary of the                                                                       available to CMS in making coverage
                                                                                                      facilitate enrollment changes to a
                                              use and burden associated with the                                                                            determinations under the Medicare
                                                                                                      different PDP or a MA–PD plan offered
                                              following information collections. More                                                                       program.
                                              detailed information can be found in                    by the same parent organization, (4) to                  The MEDCACs fundamental purpose
                                              each collection’s supporting statement                  inform marketing benefits; and (5) for                is to support the principles of an
                                              and associated materials (see                           any other purpose the Secretary                       evidence-based determination process
                                              ADDRESSES).                                             determines is necessary to include in                 for Medicare’s coverage policies.
                                                                                                      order to protect the identity of                      MEDCAC panels provide advice to CMS
                                              CMS–10691 Data Request and                              individuals entitled to or enrolled in                on the strength of the evidence available
                                              Attestation for PDP Sponsors                            Medicare, and to protect the security of              for specific medical treatments and
                                                Under the PRA (44 U.S.C. 3501–                        personal health information. This                     technologies through a public,
                                              3520), federal agencies must obtain                     proposed information collection request               participatory, and accountable process.
                                              approval from the Office of Management                  would allow the PDP sponsor to submit                 DATES: Nominations must be received
                                              and Budget (OMB) for each collection of                 a request to CMS for claims data for its              by Monday, January 7, 2019.
                                              information they conduct or sponsor.                    enrollees and to attest that it will adhere           ADDRESSES: You may mail nominations
                                              The term ‘‘collection of information’’ is               to the permitted uses and limitations on
                                              defined in 44 U.S.C. 3502(3) and 5 CFR                                                                        for membership to the following
                                                                                                      the use of the Medicare claims data that              address: Centers for Medicare &
                                              1320.3(c) and includes agency requests                  are listed in 42 CFR 423.153. Form
                                              or requirements that members of the                                                                           Medicaid Services, Center for Clinical
                                                                                                      Number: CMS–10691 (OMB control                        Standards and Quality, Attention: Leah
                                              public submit reports, keep records, or                 number: 0938–TBD); Frequency:
                                              provide information to a third party.                                                                         Cromwell or Maria Ellis, 7500 Security
                                                                                                      Occasionally; Affected Public: Private                Boulevard, Mail Stop: S3–02–01,
                                              Section 3506(c)(2)(A) of the PRA
                                                                                                      sector; Number of Respondents: 63;                    Baltimore, MD 21244 or send via email
                                              requires federal agencies to publish a
                                                                                                      Total Annual Responses: 68; Total                     to MEDCACnomination@cms.hhs.gov.
                                              60-day notice in the Federal Register
                                              concerning each proposed collection of                  Annual Hours: 1.36. (For policy                       FOR FURTHER INFORMATION CONTACT:
                                              information, including each proposed                    questions regarding this collection                   Maria Ellis, Executive Secretary for the
                                              extension or reinstatement of an existing               contact Kari Gaare at 410–786–8612.)                  MEDCAC, Centers for Medicare &
                                              collection of information, before                          Dated: November 27, 2018.                          Medicaid Services, Center for Clinical
                                              submitting the collection to OMB for                                                                          Standards and Quality, Coverage and
                                                                                                      William N. Parham, III,
                                              approval. To comply with this                                                                                 Analysis Group, S3–02–01, 7500
                                                                                                      Director, Paperwork Reduction Staff, Office           Security Boulevard, Baltimore, MD
                                              requirement, CMS is publishing this                     of Strategic Operations and Regulatory
                                              notice.                                                                                                       21244 or contact Ms. Ellis by phone
                                                                                                      Affairs.
                                                                                                                                                            (410–786–0309) or via email at
                                              Information Collection                                  [FR Doc. 2018–26052 Filed 11–29–18; 8:45 am]
                                                                                                                                                            Maria.Ellis@cms.hhs.gov.
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                                                Type of Information Collection                        BILLING CODE 4120–01–P
                                                                                                                                                            SUPPLEMENTARY INFORMATION:
                                              Request: New collection (request for a
                                              new OMB control number); Title of                                                                             I. Background
                                              Information Collection: Data Request                                                                            The Secretary signed the initial
                                              and Attestation for PDP Sponsors; Use:                                                                        charter for the Medicare Coverage
                                              Section 50354 of the Bipartisan Budget                                                                        Advisory Committee (MCAC) on
                                              Act of 2018 (BBA) provides that the                                                                           November 24, 1998. A notice in the


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Document Created: 2018-11-30 04:35:34
Document Modified: 2018-11-30 04:35:34
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 must be received by January 29, 2019.
ContactWilliam Parham at (410) 786-1326.
FR Citation83 FR 61638 

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