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[Federal Register Volume 79, Number 105 (Monday, June 2, 2014)]
[Notices]
[Pages 31335-31336]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12665]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10277 and CMS-10518]

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

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 (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 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 on the collection(s) of information must be received by 
the OMB desk officer by June 30, 2014.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax Number: (202) 395-5806 OR, Email: OIRA_submission@omb.eop.gov.
    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,

[[Page 31336]]

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: 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 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: Revision of a currently 
approved collection; Title of Information Collection: Hospice 
Conditions of Participation and Supporting Regulations; Use: The 
Conditions of Participation and accompanying requirements are used by 
federal or state surveyors as a basis for determining whether a hospice 
qualifies for approval or re-approval under Medicare. The healthcare 
industry and CMS believe that the availability to the hospice of the 
type of records and general content of records, which the final rule 
(72 FR 32088) specifies, is standard medical practice, and is necessary 
in order to ensure the well-being and safety of patients and 
professional treatment accountability. Subsequent to the publication of 
the 60-day Federal Register notice (November 29, 2013; 78 FR 71617), 
the burden hours previously accounted for in OMB control number 0938-
0302 have been updated and moved under this package to consolidate all 
hospice-related burden into a single package. Form Number: CMS-10277 
(OCN: 0938-1067); Frequency: Yearly; Affected Public: Private sector 
(business or other for-profit and not-for-profit institutions); Number 
of Respondents: 3,897; Total Annual Responses: 19,654,387; Total Annual 
Hours: 3,300,735. (For policy questions regarding this collection 
contact Danielle Shearer at 410-786-6617.)
    2. 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. 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 are would be eligible for in the 
absence of the demonstration. Subsequent to the publication of the 60-
day Federal Register notice (March 7, 2014; 79 FR 13058), the 
application has been revised by changing the order of the questions, 
rewording questions, and allowing more response options. 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: May 28, 2014.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2014-12665 Filed 5-30-14; 8:45 am]
BILLING CODE 4120-01-P
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