[Federal Register Volume 79, Number 45 (Friday, March 7, 2014)]
[Notices]
[Pages 13058-13059]
From the Federal Register Online via the Government Publishing 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 [email protected].
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