[Federal Register Volume 81, Number 27 (Wednesday, February 10, 2016)]
[Notices]
[Pages 7124-7126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02686]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-276, CMS-1957, CMS-10599 and CMS-10600]


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 April 11, 2016:

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. 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 <a href="/cdn-cgi/l/email-protection#0f5f6e7f6a7d78607d644f6c627c2167677c21686079"><span class="__cf_email__" data-cfemail="2e7e4f5e4b5c59415c456e4d435d0046465d00494158">[email protected]</span></a>.
    3. Call the Reports Clearance Office at (410) 786-1326.

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

SUPPLEMENTARY INFORMATION: 

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-276 Prepaid Health Plan Cost Report
CMS-1957 Social Security Office (SSO) Report of State Buy-in Problem
CMS-10599 Medicare Prior Authorization of Home Health Services 
Demonstration
CMS-10600 Evaluation of the Medicare Patient Intravenous Immunoglobulin 
Demonstration

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain 
approval from the Office of Management

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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.
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Prepaid Health 
Plan Cost Report; Use: Health Maintenance Organizations and Competitive 
Medical Plans (HMO/CMPs) contracting with the Secretary under Section 
1876 of the Social Security Act are required to submit a budget and 
enrollment forecast, semi-annual interim report, 4th Quarter interim 
report, and a final certified cost report in accordance with 42 CFR 
417.572-417.576. Health Care Prepayment Plans (HCPPs) contracting with 
the Secretary under Section 1833 of the Social Security Act are 
required to submit a budget and enrollment forecast, semi-annual 
interim report, and final cost report in accordance with 42 CFR 417.808 
and 42 CFR 417.810. Form Number: CMS-276 (OMB control number 0938-
0165); Frequency: Quarterly; Affected Public: Private Sector (Business 
or other for-profits); Number of Respondents: 91; Total Annual 
Responses: 74; Total Annual Hours: 3728. (For policy questions 
regarding this collection contact Bilal Farrakh at 410-786-4456.)
    2. Type of Information Collection Request: Reinstatement of a 
previously approved collection; Title of Information Collection: Social 
Security Office (SSO) Report of State Buy-in Problem; Use: Under 
Section 1843 of the Social Security Act, States may enter into an 
agreement with the Department of Health and Human Services to enroll 
eligible individuals in Medicare and pay their premiums. The purpose of 
the State Buy-in' program is to assure that Medicaid is the payer of 
last resort by permitting a State to provide Medicare protection to 
certain groups of needy individuals, as part of the State's total 
assistance plan. State Buy-in also has the effect of transferring some 
medical costs for this population from the Medicaid program, which is 
partially State funded to the Medicare program, which is funded by the 
federal government and individual premiums. Generally, the States Buy-
in for individuals who meet the eligibility requirements for Medicare 
and are cash recipients or deemed cash recipients or categorically 
needy under Medicaid. In some cases, States may also include 
individuals who are not cash assistance recipients under the Medical 
Assistance Only group. The day-to-day operations of the State Buy-in 
program is accomplished through an automated data exchange process. The 
automated data exchange process is used to exchange Medicare and Buy-in 
entitlement information between the Social Security District Offices, 
Medicaid State Agencies and the Centers for Medicare & Medicaid 
Services. When problems arise however that cannot be resolved though 
the normal data exchange process, clerical actions are required. The 
CMS-1957, ``SSO Report of State Buy-In Problem'' is used to report Buy-
in problems cases. The CMS-1957 is the only standardized form available 
for communications between the aforementioned agencies for the 
resolution of beneficiary complaints and inquiries regarding State Buy-
in eligibility. Form Number: CMS-1957 (OMB control number: 0938-0035); 
Frequency: Reporting--Annually; Affected Public: Individuals and 
Households; Number of Respondents: 3,936; Total Annual Responses: 
3,936; Total Annual Hours: 1,311. (For policy questions regarding this 
collection contact Keith Robinson at 410-786-1148.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicare Prior 
Authorization of Home Health Services Demonstration; Use: Section 
402(a)(1)(J) of the Social Security Amendments of 1967 (42 U.S.C. 
1395b-1(a)(1)(J)) authorizes the Secretary to ``develop or demonstrate 
improved methods for the investigation and prosecution of fraud in the 
provision of care or services under the health programs established by 
the Social Security Act (the Act).'' In accordance with this authority, 
we seek to develop and implement a Medicare demonstration project, 
which we believe will help assist in developing improved procedures for 
the identification, investigation, and prosecution of Medicare fraud 
occurring among HHAs providing services to Medicare beneficiaries.
    This demonstration would help assure that payments for home health 
services are appropriate before the claims are paid, thereby preventing 
fraud, waste, and abuse. As part of this demonstration, we propose 
performing prior authorization before processing claims for home health 
services in: Florida, Texas, Illinois, Michigan, and Massachusetts. We 
would establish a prior authorization procedure that is similar to the 
Prior Authorization of Power Mobility Device (PMD) Demonstration, which 
was implemented by CMS in 2012. This demonstration would also follow 
and adopt prior authorization processes that currently exist in other 
health care programs such as TRICARE, certain state Medicaid programs, 
and in private insurance.
    The information required under this collection is requested by 
Medicare contractors to determine proper payment or if there is a 
suspicion of fraud. Medicare contractors will request the information 
from HHA providers submitting claims for payment from the Medicare 
program in advance to determine appropriate payment. Form Number: CMS-
10599 (OMB control number: 0938-NEW); Frequency: Occasionally; Affected 
Public: Private sector (Business or other for-profits and Not-for-
profits); Number of Respondents: 908,740; Number of Responses: 908,740; 
Total Annual Hours: 454,370. (For questions regarding this collection 
contact Carla David (410)786-4799.)
    4. 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

[[Page 7126]]

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:
    <bullet> Evaluate the impact of the Medicare IVIG Access 
Demonstration project on Medicare beneficiary access to IVIG at home,
    <bullet> Determine the appropriateness of implementing a new 
payment methodology for IVIG in all settings and determining an 
appropriate payment amount, and
    <bullet> 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 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: February 5, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-02686 Filed 2-9-16; 8:45 am]
BILLING CODE 4120-01-P


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