[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61638-61639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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