[Federal Register Volume 77, Number 170 (Friday, August 31, 2012)]
[Notices]
[Pages 53202-53203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-21594]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10443 and CMS-10149]


Agency Information Collection Activities: Proposed Collection; 
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) 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 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.
    1. 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

[[Page 53203]]

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.)
    2. Type of Information Collection Request: Reinstatement without 
change of a previously approved collection; Title of Information 
Collection: Health Insurance Reform: Electronic Security Standards; 
Use: This information collection corresponds to existing regulations 
establishing standards for the security of electronic protected health 
information to be implemented by health plans, health care 
clearinghouses and certain health care providers, as required under 
title II, subtitle F, sections 261 through 264 of the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191. 
The use of the security standards improves Federal health programs, 
private health programs, and the effectiveness and efficiency of the 
health care industry in general by establishing a level of protection 
for certain electronic health information. This information collection 
request does not propose any changes to this information collection 
related to future modifications of the underlying HIPAA security 
standards. Form Number: CMS-10149 (OCN: 0938-0949); Frequency: 
Occasionally; Affected Public: Business or other for-profit, Not-for-
profit institutions, Federal Government, and State, Local or Tribal 
Government; Number of Respondents: 135,560; Total Annual Responses: 
285,560; Total Annual Hours: 536,743. (For policy questions regarding 
this collection contact William Parham at 410-786-4669. 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 address at http://www.cms.hhs.gov/PaperworkReductionActof1995, 
or Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected], or call 
the Reports Clearance Office on (410) 786-1326.
    In commenting on the proposed information collections please 
reference the document identifier or OMB control number. To be assured 
consideration, comments and recommendations must be submitted in one of 
the following ways by October 30, 2012:
    1. Electronically. You may submit 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) 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: CMS-R-284 (OCN 0938-
0345), Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 
21244-1850.

    Dated: August 28, 2012.
Martique Jones,
Director, Regulations Development Group, Division B, Office of 
Strategic Operations and Regulatory Affairs.
[FR Doc. 2012-21594 Filed 8-30-12; 8:45 am]
BILLING CODE 4120-01-P