[Federal Register Volume 86, Number 28 (Friday, February 12, 2021)]
[Notices]
[Pages 9348-9349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02944]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers CMS-10518 and CMS-10340]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

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 April 13, 2021.

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 
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 https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

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-10518 Application for Participation in the Intravenous Immune 
Globulin (IVIG) Demonstration
CMS-10340 Collection of Encounter Data from MA Organizations

    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

    1. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Application for Participation in the Intravenous Immune Globulin (IVIG) 
Demonstration; Use: Traditional fee-for-service (FFS) Medicare covers 
some or all components of home infusion services depending on the 
circumstances. By special statutory provision, Medicare Part B covers 
intravenous immune globulin (IVIG) for persons with primary immune 
deficiency disease (PIDD) who wish to receive the drug at home. 
However, Medicare does not separately pay for any services or supplies 
to administer it if the person is not homebound and otherwise receiving 
services under a Medicare Home Health episode of care. As a result, 
many beneficiaries have chosen to receive the drug at their doctor's 
office or in an outpatient hospital setting.
    The Medicare IVIG Demonstration application requests basic 
demographic information necessary to determine eligibility for 
participation in the demonstration. This information is used by CMS' 
implementation support contractor to determine eligibility for the 
demonstration and to set up a demonstration eligibility record that is 
used by the Medicare claims system when processing claims for 
demonstration services.
    The application also includes some questions about how and where 
the beneficiary is currently receiving immunoglobulin and related 
services. This data is being used by the evaluation contractor to 
conduct its evaluation and to better understand

[[Page 9349]]

which beneficiaries are electing to enroll in the demonstration. Form 
Number: CMS-10518 (OMB control number: 0938-1246); Frequency: Annually; 
Affected Public: Individuals and Households; Number of Respondents: 
6,500; Total Annual Responses: 6,500; Total Annual Hours: 1,625. (For 
policy questions regarding this collection contact Debra K. Gillespie 
at 410-786-4631.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Collection of 
Encounter Data from MA Organizations; Use: Section 1853(a)(3)(B) of the 
Act directs CMS to require MA organizations and eligible organizations 
with risk-sharing contracts under 1876 to ``submit data regarding 
inpatient hospital services . . . and data regarding other services and 
other information as the Secretary deems necessary'' in order to 
implement a methodology for ``risk adjusting'' payments made to MA 
organizations and other entities. Risk adjustments to enrollee monthly 
payments are made in order to take into account ``variations in per 
capita costs based on [the] health status'' of the Medicare 
beneficiaries enrolled in an MA plan.
    CMS collects encounter data for beneficiaries enrolled in MA 
organizations, section 1876 Cost Health Maintenance Organizations 
(HMOs)/Competitive Medical Plans (CMPs), Programs of All-inclusive Care 
for the Elderly (PACE) organizations, and MMPs. For PACE organizations 
and MMPs, encounter data serves essentially the same purposes as it 
does for the MA program (for Part C and Part D risk adjustment). To 
1876 Cost Plans that offer Part D coverage, CMS makes risk adjusted, 
capitated monthly payments for Part D.
    MA organizations, Part D organizations, 1876 Cost Plans, MMPs and 
PACE organizations must use a CMS approved Network Service Vendor to 
establish connectivity with the CMS secure network for operational 
purposes. Once connectivity is established, these entities must submit 
required documents to CMS's front-end contractor to obtain security 
access credentials. Form Number: CMS-10340 (OMB control number: 0938-
1152); Frequency: Annually; Affected Public: Private Sector, Business 
or other for-profits, Not-for-profits institutions; Number of 
Respondents: 733; Total Annual Responses: 1,068,204,429; Total Annual 
Hours: 35,618,366. (For policy questions regarding this collection 
contact Michael P. Massimini at 410-786-1560.)

    Dated: February 9, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-02944 Filed 2-11-21; 8:45 am]
BILLING CODE 4120-01-P