[Federal Register Volume 79, Number 239 (Friday, December 12, 2014)]
[Notices]
[Pages 73891-73892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29172]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers CMS-10341, CMS-R-246 and CMS-10531]


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 a 
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 February 10, 2015.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number (OCN). 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 [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:

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-10341 Affordable Care Act Information and Collection Requirements 
for Section 1115 Demonstration Projects
CMS-R-246 Medicare Advantage, Medicare Part D, and Medicare Fee-For-
Service Consumer Assessment of Healthcare Providers and Systems (CAHPS) 
Survey
CMS-10531 Transcatheter Mitral Valve Repair (TMVR) National Coverage 
Decision (NCD)

    Under the Paperwork Reduction Act (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 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.

Information Collection

    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Affordable Care 
Act Information and Collection Requirements for Section 1115 
Demonstration Projects; Use: This collection is necessary to ensure 
that states comply with regulatory and statutory requirements related 
to the development, implementation and evaluation of demonstration 
projects. States seeking waiver authority under Section 1115 are 
required to meet certain requirements for public notice, the evaluation 
of demonstration projects, and reports to the Secretary on the 
implementation of approved demonstrations. Form Number: CMS-10341 (OMB 
control number 0938-1162); Frequency: Yearly; Affected Public: State, 
Local, or Tribal Governments; Number of Respondents: 37; Total Annual 
Responses: 130; Total Annual Hours: 13,910. (For policy questions 
regarding this collection contact Lane Terwilliger at 410-786-2059).
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicare 
Advantage, Medicare Part D, and Medicare Fee-For-Service Consumer 
Assessment of Healthcare Providers and Systems (CAHPS) Survey; Use: The 
primary purpose of the Medicare consumer assessment of healthcare 
providers and systems (CAHPS) surveys is to provide information to 
Medicare beneficiaries to help them make more informed choices among 
health and prescription drug plans available to them. The surveys also 
provides data to help CMS and others monitor the quality and 
performance of Medicare health and prescription drug plans and identify 
areas to improve the quality of care and services provided to enrollees 
of these plans. Form Number: CMS-R-246 (OMB control number: 0938-0732; 
Frequency: Yearly; Affected Public: Individuals and households; Number 
of Respondents: 799,650; Total Annual Responses: 799,650; Total Annual 
Hours: 277,740 (For policy questions regarding this collection contact 
Sarah Gaillot at 410-786-4637).
    3. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Transcatheter Mitral Valve Repair (TMVR) National Coverage Decision 
(NCD); Use: The data collection is required by the Centers for Medicare 
and Medicaid Services (CMS) National Coverage Determination (NCD) 
entitled, ``Transcatheter Mitral Valve Repair (TMVR)''. The TMVR device 
is only covered when specific conditions are met including that the 
heart team

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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.
    We find 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 TMVR. The TVT Registry will 
support a national surveillance system to monitor the safety and 
efficacy of the TMVR technologies for the treatment of mitral 
regurgitation (MR). 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 pursuant 
to 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 to 
determine if TMVR 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 mitral 
regurgitation. For purposes of the TMVR 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-10531(OMB Control Number: 0938-NEW); 
Frequency: Annually; Affected Public: Business or other for-profits; 
Number of Respondents: 4,000; Total Annual Responses: 16,000 Total 
Annual Hours: 5,600. (For policy questions regarding this collection 
contact Roya Lotfi at 410-786-4072.)

    Dated: December 9, 2014.
Martique Jones,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 2014-29172 Filed 12-11-14; 8:45 am]
BILLING CODE 4120-01-P