[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Pages 68785-68787]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27841]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10028, CMS-10180, CMS-R-199 and CMS-10443]


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

AGENCY: Centers for Medicare & Medicaid Services, HHS.

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid 
Services (CMS), Department of Health and Human Services, is publishing 
the following summary of proposed collections for public comment. 
Interested persons are invited to send comments regarding this 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 function; (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.
    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Children's Health 
Insurance Program (CHIP) Report on Payables and Receivables; Use: 
Collection of CHIP data and the calculation of the CHIP Incurred But 
Not Reported (IBNR) estimate are pertinent to CMS' financial audit. The 
CFO auditors have reported the lack of an estimate for CHIP IBNR 
payables and receivables as a reportable condition in the FY 2005 audit 
of CMS's financial statements. It is essential that CMS collect the 
necessary data from State agencies in FY 2006, so that CMS continues to 
receive an unqualified audit opinion on its financial statements. 
Program expenditures for the CHIP have increased since its inception; 
as such, CHIP receivables and payables may materially impact the 
financial statements. The CHIP Report on Payables and Receivables will 
provide the information needed to calculate the CHIP IBNR.; Form 
Number: CMS-10180 (OMB: 0938-0988); Frequency: Reporting--
Annually; Affected Public: State, Local or Tribal governments; Number 
of Respondents: 56; Total Annual Responses: 56; Total Annual Hours: 
392. (For policy questions regarding this collection contact Michele 
Myers at 410-786-7911. For all other issues call 410-786-1326.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Medicaid Report 
on Payables and Receivables; Use: The Chief Financial Officers (CFO) 
Act of 1990, as amended by the Government Management Reform Act (GMRA) 
of 1994, requires government agencies to produce auditable financial 
statements. Because the Centers for Medicare & Medicaid Services (CMS) 
fulfills its

[[Page 68786]]

mission through its contractors and the States; these entities are the 
primary source of information for the financial statements. There are 
three basic categories of data: expenses, payables, and receivables. 
The CMS-64 is used to collect data on Medicaid expenses. The CMS-R-199 
collects Medicaid payable and receivable accounting data from the 
States. Form Number: CMS-R-199 (OMB: 0938-0697); Frequency: 
Reporting--Annually; Affected Public: State, Local or Tribal 
governments; Number of Respondents: 56; Total Annual Responses: 56; 
Total Annual Hours: 336. (For policy questions regarding this 
collection contact Michele Myers at 410-786-7911. For all other issues 
call 410-786-1326.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: State Health 
Insurance Assistance Program (SHIP) Client Contact Form, Public and 
Media Activity Report Form, and Resource Report Form. Use: Section 
4360(f) of the Omnibus Budget Reconciliation Act (OBRA) 1990 requires 
the Secretary to provide a series of reports to the U.S. Congress on 
the performance of the program and its impact on beneficiaries and to 
obtain important informational feedback from beneficiaries. Further, in 
response to requirements of the Balanced Budget Act of 1997, CMS 
launched a comprehensive five-year campaign, the National Medicare 
Education Program (NMEP), to raise awareness among beneficiaries about 
their Medicare health plan options and help them assess the advantages 
and disadvantages each choice holds for them. The Medicare 
Modernization Act (MMA) of 2003 required State Health Insurance 
Assistance Programs (SHIPs) to be actively engaged in the 
implementation of the Medicare Prescription Drug Program (Part D). 
MIPPA legislation and Affordable Care Act legislation required SHIPs to 
provide enrollment assistance for the Limited Income Subsidy (LIS) and 
Medicare Savings Program (MSP). The goal is to ensure that 
beneficiaries are making an informed choice, regardless of whether they 
stay in Original Medicare or choose new options. CMS is responsible to 
Congress for demonstrating improvement over time in the level of 
awareness and understanding beneficiaries have about health plan 
options. The SHIPs are an integral component of this initiative. The 
information collected is used to fulfill the reporting requirements 
described in Section 4360(f) of OBRA 1990. CMS will utilize this data. 
The data will be accumulated and analyzed to measure SHIP performance 
in order to determine whether and to what extent the SHIPs have met the 
goals of improved CMS customer service to beneficiaries and better 
understanding by beneficiaries of their health insurance options. 
Further, the information will be used in the administration of the 
grants, to measure performance and appropriate use of the funds by the 
state grantees, to identify gaps in services and technical support 
needed by SHIPs, and to identify and share best practices.
    The overall burden of hours and expected number of respondents 
increase is based on projected future service growth and projected 
future increases in staffing to accommodate the increased demand to 
utilize the SHIP network to raise awareness about new CMS policies, 
outreach initiatives, or both. However, the instruments themselves have 
not changed. Form Number: CMS-10028 (OCN: 0938-0850); Frequency: 
Occasionally; Affected Public: State, Local, or Tribal Governments; 
Number of Respondents: 17,838; Total Annual Responses: 2,346,465. Total 
Annual Hours: 195,642. (For policy questions regarding this collection 
contact Gregory Price at 410-786-4041. For all other issues call 410-
786-1326.)
    4. Type of Information Collection Request: New collection. Title of 
Information Collection: Transcatheter Valve Therapy Registry and KCCQ-
10. Use: The data collection is required by the Centers for Medicare 
and Medicaid Services (CMS) National Coverage Determination (NCD) 
entitled, ``Transcatheter Aortic Valve Replacement (TAVR)''. The TAVR 
device is only covered when specific conditions are met including that 
the heart team and hospital are submitting data in a prospective, 
national, audited registry. The data includes patient, practitioner and 
facility level variables that predict outcomes such as all cause 
mortality and quality of life. CMS finds that the Society of Thoracic 
Surgery/American College of Cardiology Transcatheter Valve Therapy 
(STS/ACC TVT) Registry, one registry overseen by the National 
Cardiovascular Data Registry, meets the requirements specified in the 
NCD on TAVR. The TVT Registry will support a national surveillance 
system to monitor the safety and efficacy of the TAVR technologies for 
the treatment of aortic stenosis.
    The data will also include the variables on the eight item Kansas 
City Cardiomyopathy Questionnaire (KCCQ-10) to assess heath status, 
functioning and quality of life. In the KCCQ, an overall summary score 
can be derived from the physical function, symptoms (frequency and 
severity), social function and quality of life domains. For each 
domain, the validity, reproducibility, responsiveness and 
interpretability have been independently established. Scores are 
transformed to a range of 0-100, in which higher scores reflect better 
health status.
    The conduct of the STS/ACC TVT Registry and the KCCQ-10 is in 
accordance with Section 1142 of the Social Security Act (the Act) that 
describes the authority of the Agency for Healthcare Research and 
Quality (AHRQ). Under section 1142, research may be conducted and 
supported on the outcomes, effectiveness, and appropriateness of health 
care services and procedures to identify the manner in which disease, 
disorders, and other health conditions can be prevented, diagnosed, 
treated, and managed clinically. Section 1862(a)(1)(E) of the Act 
allows Medicare to cover under coverage with evidence development (CED) 
certain items or services for which the evidence is not adequate to 
support coverage under section 1862(a)(1)(A) and where additional data 
gathered in the context of a clinical setting would further clarify the 
impact of these items and services on the health of beneficiaries.
    The data collected and analyzed in the TVT Registry will be used by 
CMS to determine if the TAVR is reasonable and necessary (e.g., 
improves health outcomes) for Medicare beneficiaries under Section 
1862(a)(1)(A) of the Act. Furthermore, data from the Registry will 
assist the medical device industry and the Food and Drug Administration 
(FDA) in surveillance of the quality, safety and efficacy of new 
medical devices to treat aortic stenosis. For purposes of the TAVR NCD, 
The TVT Registry has contracted with the Data Analytic Centers to 
conduct the analyses. In addition, data will be made available for 
research purposes under the terms of a data use agreement that only 
provides de-identified datasets. Form Number: CMS-10443 (OCN: 0938-
New); Frequency: Annual; Affected Public: Individuals, Households and 
Private Sector; Number of Respondents: 12,000; Total Annual Responses: 
24,000; Total Annual Hours: 7,000. (For policy questions regarding this 
collection contact JoAnna Baldwin at 410-786-7205. For all other issues 
call 410-786-1326.)
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS Web 
site

[[Page 68787]]

address at http://www.cms.hhs.gov/PaperworkReductionActof1995, or email 
your request, including your address, phone number, OMB number, and CMS 
document identifier, to Paperwork@cms.hhs.gov, or call the Reports 
Clearance Office on (410) 786-1326.
    To be assured consideration, comments and recommendations for the 
proposed information collections must be received by the OMB desk 
officer at the address below, no later than 5 p.m. on December 17, 
2012. OMB, Office of Information and Regulatory Affairs, Attention: CMS 
Desk Officer, Fax Number: (202) 395-6974, Email: OIRA_submission@omb.eop.gov.

    Dated: November 9, 2012.
Martique Jones,
Director, Regulations Development Group, Division B, Office of 
Strategic Operations and Regulatory Affairs.
[FR Doc. 2012-27841 Filed 11-15-12; 8:45 am]
BILLING CODE 4120-01-P