Agency Information Collection Activities: Submission for OMB Review; Comment Request, 23704-23705 [2016-09415]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23704-23705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09415]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10600]


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

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 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 May 23, 2016.

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 https://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: 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: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Evaluation of the Medicare Patient Intravenous Immunoglobulin 
Demonstration; Use: Primary Immune Deficiency Diseases (PIDD) are 
caused by genetic defects that result in a lack of and/or impaired 
antibody function. Without antibodies, the body's immune system is not 
able to function effectively. Immunoglobulin (IG) therapy is used to 
temporarily replace some of the antibodies (immunoglobulins) that are 
missing or not working properly in people with PIDD.
    By special statutory provision, Medicare Part B covers intravenous 
immunoglobulin (IVIG) for persons with PIDD who wish to receive the 
drug in-home, but does not allow for Medicare to cover any of the items 
and services needed to administer the drug unless the person is 
homebound or otherwise receiving services under a Medicare home health 
episode of care. Therefore, most beneficiaries with PIDD receive 
treatment at hospital outpatient departments, physicians' offices, and 
other outpatient settings. A current alternative to IVIG is 
subcutaneous immunoglobulin (SCIG), a product that permits some 
beneficiaries to self-administer the immunoglobulin (IG) safely at home 
without an attending healthcare professional. SCIG at home is 
reimbursed by Medicare. However, there are limitations to SCIG--e.g., 
the need for more frequent administration and higher volumes of 
solution, which can reach a maximum absorbable level for some patients 
that is below their optimum IG treatment level--that inhibit more 
widespread use of SCIG.
    Under the Medicare Patient IVIG Access Demonstration project, by 
paying for the items and services needed to administer the IVIG drug 
in-home, Medicare will enable beneficiaries and their physicians to 
have greater flexibility in choosing the option that is most 
appropriate for the beneficiary. With the exception of coverage of 
these items and services, no other aspects of Medicare coverage for 
IVIG (e.g., drugs approved for coverage or PIDD diagnoses covered) will 
change under the demonstration.
    The Medicare Patient IVIG Access Demonstration project mandates CMS 
to:
     Evaluate the impact of the Medicare IVIG Access 
Demonstration project on Medicare beneficiary access to IVIG at home,
     Determine the appropriateness of implementing a new 
payment methodology for IVIG in all settings and determining an 
appropriate payment amount, and
     Update the existing 2007 Office of the Assistant Secretary 
for Planning and Evaluation (ASPE) report Analysis of Supply, 
Distribution, Demand, and Access Issues Associated with Immune Globulin 
Intravenous (IGIV) (2007 ASPE Report).
    The impact evaluation seeks to understand the experiences of 
demonstration participants and non-participants, to update the 2007 
ASPE report, and to support the payment methodology through the use of 
qualitative and quantitative data collection. The qualitative data 
collection will consist of a series of stakeholder interviews. 
Interviews with IVIG/SCIG physicians and nurses will provide 
information on the experiences of beneficiaries from the perspective of 
those who have significant, in-depth and practical hands-on experience 
with delivering IG to Medicare beneficiaries with and without access to 
home infusions. We will be able to gather their

[[Page 23705]]

knowledge of beneficiaries' experiences with the care, as well as 
information on any potential health consequences due to changes in IG 
medication or participation in the Demonstration. Lastly, we will 
gather the physicians and nurses' views of the degree to which 
beneficiaries believe the program is effective, including the cost 
effectiveness for beneficiaries who use the services provided under the 
Demonstration. Form Number: CMS-10600 (OMB control number: 0938-NEW); 
Frequency: Annually; Affected Public: Individuals and Households; 
State, Local or Tribal Governments; Private Sector (Business or other 
for-profit); Number of Respondents: 2,488; Total Annual Responses: 
2,488; Total Annual Hours: 483. (For policy questions regarding this 
collection contact Pauline Karikari-Martin at 410-786-1040).

     Dated: April 19, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-09415 Filed 4-21-16; 8:45 am]
 BILLING CODE 4120-01-P