[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21740-21741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08515]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10518]


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

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
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 May 24, 2021.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain . Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    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.

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

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

[[Page 21741]]

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:
    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 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.)

    Dated: April 20, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-08515 Filed 4-22-21; 8:45 am]
BILLING CODE 4120-01-P