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[Federal Register Volume 79, Number 45 (Friday, March 7, 2014)]
[Notices]
[Pages 13058-13059]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04998]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10518]

Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid 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 any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.

DATES: Comments must be received by May 6, 2014.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number (OCN). 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' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
    3. Call the Reports Clearance Office at (410) 786-1326.

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

SUPPLEMENTARY INFORMATION:

[[Page 13059]]

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

    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: New collection (Request 
for a new OMB control number); 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. On Tuesday, January 3, 
2012, the President signed into law the ``Medicare IVIG Access and 
Strengthening Medicare and Repaying Taxpayers Act of 2012''. The act 
authorizes a 3-year demonstration under Part B of Title XVIII of the 
Social Security Act to evaluate the benefits of providing payment for 
items and services needed for the in-home administration of IVIG for 
the treatment of PIDD.
    The statute limited the demonstration to 4,000 beneficiaries and 
$45 million, including administrative expenses for implementation and 
evaluation as well as benefit costs. The statute also required that an 
evaluation of the demonstration be conducted. Under this demonstration, 
Medicare will issue under Part B a bundled payment for all medically 
necessary supplies and services to administer IVIG in the home to 
enrolled beneficiaries who are not otherwise homebound and receiving 
home health care benefits. In order to implement the demonstration and 
ensure that statutory limits are not exceeded, it is necessary to 
positively enroll beneficiaries in the demonstration.
    This collection of information is for the application to 
participate in the demonstration. Participation is voluntary and may be 
terminated by the beneficiary at any time. Beneficiaries who do not 
participate will continue to be eligible to receive all of the regular 
Medicare Part B benefits that they would be eligible for in the absence 
of the demonstration. Form Number: CMS-10518 (OCN: 0938-NEW); 
Frequency: Annually; Affected Public: Individuals and households; 
Number of Respondents: 4,000; Total Annual Responses: 4,000 Total 
Annual Hours: 1,000. (For policy questions regarding this collection 
contact Jody Blatt at 410-786-6921.)

    Dated: March 4, 2014.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2014-04998 Filed 3-6-14; 8:45 am]
BILLING CODE 4120-01-P
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