81 FR 23704 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

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

Federal Register Volume 81, Issue 78 (April 22, 2016)

Page Range		23704-23705
FR Document		2016-09415

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.

Federal Register, Volume 81 Issue 78 (Friday, April 22, 2016)

[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23704-23705]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-09415]


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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.

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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 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: 
[email protected].
    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: 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

23704 Federal Register / Vol. 81, No. 78 / Friday, April 22, 2016 / Notices

Leroy A. Richardson, proposed collection(s) summarized in most beneficiaries with PIDD receive
Chief, Information Collection Review Office, this notice, you may make your request treatment at hospital outpatient
Office of Scientific Integrity, Office of the using one of following: departments, physicians’ offices, and
Associate Director for Science, Office of the 1. Access CMS’ Web site address at other outpatient settings. A current
Director, Centers for Disease Control and http://www.cms.hhs.gov/Paperwork alternative to IVIG is subcutaneous
Prevention. ReductionActof1995. immunoglobulin (SCIG), a product that
[FR Doc. 2016–09398 Filed 4–21–16; 8:45 am] 2. Email your request, including your permits some beneficiaries to self-
BILLING CODE 4163–18–P address, phone number, OMB number, administer the immunoglobulin (IG)
and CMS document identifier, to safely at home without an attending
Paperwork@cms.hhs.gov. healthcare professional. SCIG at home is
DEPARTMENT OF HEALTH AND 3. Call the Reports Clearance Office at reimbursed by Medicare. However,
HUMAN SERVICES (410) 786–1326. there are limitations to SCIG—e.g., the
FOR FURTHER INFORMATION CONTACT: need for more frequent administration
Centers for Medicare & Medicaid and higher volumes of solution, which
Reports Clearance Office at (410) 786–
Services can reach a maximum absorbable level
1326.
[Document Identifiers: CMS–10600] for some patients that is below their
SUPPLEMENTARY INFORMATION: Under the
optimum IG treatment level—that
Agency Information Collection Paperwork Reduction Act of 1995 (PRA)
inhibit more widespread use of SCIG.
Activities: Submission for OMB (44 U.S.C. 3501–3520), federal agencies Under the Medicare Patient IVIG
Review; Comment Request must obtain approval from the Office of Access Demonstration project, by
Management and Budget (OMB) for each paying for the items and services
ACTION: Notice. collection of information they conduct needed to administer the IVIG drug in-
or sponsor. The term ‘‘collection of home, Medicare will enable
SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C.
Medicaid Services (CMS) is announcing beneficiaries and their physicians to
3502(3) and 5 CFR 1320.3(c) and have greater flexibility in choosing the
an opportunity for the public to includes agency requests or
comment on CMS’ intention to collect option that is most appropriate for the
requirements that members of the public beneficiary. With the exception of
information from the public. Under the submit reports, keep records, or provide
Paperwork Reduction Act of 1995 coverage of these items and services, no
information to a third party. Section other aspects of Medicare coverage for
(PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C.
publish notice in the Federal Register IVIG (e.g., drugs approved for coverage
3506(c)(2)(A)) requires federal agencies or PIDD diagnoses covered) will change
concerning each proposed collection of to publish a 30-day notice in the
information, including each proposed under the demonstration.
Federal Register concerning each The Medicare Patient IVIG Access
extension or reinstatement of an existing proposed collection of information, Demonstration project mandates CMS
collection of information, and to allow including each proposed extension or to:
a second opportunity for public reinstatement of an existing collection • Evaluate the impact of the Medicare
comment on the notice. Interested of information, before submitting the IVIG Access Demonstration project on
persons are invited to send comments collection to OMB for approval. To Medicare beneficiary access to IVIG at
regarding the burden estimate or any comply with this requirement, CMS is home,
other aspect of this collection of publishing this notice that summarizes • Determine the appropriateness of
information, including any of the the following proposed collection(s) of implementing a new payment
following subjects: (1) The necessity and information for public comment: methodology for IVIG in all settings and
utility of the proposed information 1. Type of Information Collection determining an appropriate payment
collection for the proper performance of Request: New collection (Request for a amount, and
the agency’s functions; (2) the accuracy new OMB control number); Title of • Update the existing 2007 Office of
of the estimated burden; (3) ways to Information Collection: Evaluation of the Assistant Secretary for Planning and
enhance the quality, utility, and clarity the Medicare Patient Intravenous Evaluation (ASPE) report Analysis of
of the information to be collected; and Immunoglobulin Demonstration; Use: Supply, Distribution, Demand, and
(4) the use of automated collection Primary Immune Deficiency Diseases Access Issues Associated with Immune
techniques or other forms of information (PIDD) are caused by genetic defects that Globulin Intravenous (IGIV) (2007 ASPE
technology to minimize the information result in a lack of and/or impaired Report).
collection burden. antibody function. Without antibodies, The impact evaluation seeks to
DATES: Comments on the collection(s) of the body’s immune system is not able to understand the experiences of
information must be received by the function effectively. Immunoglobulin demonstration participants and non-
OMB desk officer by May 23, 2016. (IG) therapy is used to temporarily participants, to update the 2007 ASPE
ADDRESSES: When commenting on the replace some of the antibodies report, and to support the payment
proposed information collections, (immunoglobulins) that are missing or methodology through the use of
please reference the document identifier not working properly in people with qualitative and quantitative data
or OMB control number. To be assured PIDD. collection. The qualitative data
consideration, comments and By special statutory provision, collection will consist of a series of
recommendations must be received by Medicare Part B covers intravenous stakeholder interviews. Interviews with
mstockstill on DSK4VPTVN1PROD with NOTICES

the OMB desk officer via one of the immunoglobulin (IVIG) for persons with IVIG/SCIG physicians and nurses will
following transmissions: OMB, Office of PIDD who wish to receive the drug in- provide information on the experiences
Information and Regulatory Affairs, home, but does not allow for Medicare of beneficiaries from the perspective of
Attention: CMS Desk Officer, Fax to cover any of the items and services those who have significant, in-depth
Number: (202) 395–5806 OR Email: needed to administer the drug unless and practical hands-on experience with
OIRA_submission@omb.eop.gov. the person is homebound or otherwise delivering IG to Medicare beneficiaries
To obtain copies of a supporting receiving services under a Medicare with and without access to home
statement and any related forms for the home health episode of care. Therefore, infusions. We will be able to gather their

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Document Created: 2017-08-22 23:37:27
Document Modified: 2017-08-22 23:37:27

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments on the collection(s) of information must be received by the OMB desk officer by May 23, 2016.
Contact		Reports Clearance Office at (410) 786- 1326.
FR Citation		81 FR 23704

81 FR 23704 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 81, Issue 78 (April 22, 2016)

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