```

[Federal Register Volume 80, Number 44 (Friday, March 6, 2015)]
[Notices]
[Pages 12180-12181]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05165]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-1557, CMS-10531 and CMS-10535]

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

ACTION: Notice.

-----------------------------------------------------------------------

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 April 6, 2015.

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: 
OIRA_submission@omb.eop.gov.
    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 Paperwork@cms.hhs.gov.
    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: Extension of a currently 
approved collection; Title of Information Collection: Survey Report 
Form for Clinical Laboratory Improvement Amendments (CLIA) and 
Supporting Regulations; Use: The form is used to report surveyor 
findings during a CLIA survey. For each type of survey conducted (i.e., 
initial certification, recertification, validation, complaint, 
addition/deletion of specialty/subspecialty, transfusion fatality 
investigation, or revisit inspections) the Survey Report Form 
incorporates the requirements specified in the CLIA regulations. Form 
Number: CMS-1557 (OMB control number: 0938-0544); Frequency: 
Biennially; Affected Public: Private sector (Business or other for-
profit and Not-for-profit institutions, State, Local or Tribal 
Governments and Federal Government); Number of Respondents: 19,051; 
Total Annual Responses: 9,526; Total Annual Hours: 4,763. (For policy 
questions regarding this collection contact Kathleen Todd at 410-786-
3385).
    2. 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 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

[[Page 12181]]

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: Private sector (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).
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Employer 
Notification to HHS of its Objection to Providing Coverage for 
Contraceptive Services; Use: The proposed rules titled ``Coverage of 
Certain Preventive Services Under the Affordable Care Act'' (79 FR 
51118), if finalized as proposed, would require each qualifying 
closely-held, for-profit entity seeking to be treated as an eligible 
organization to provide notification of its religious objection to 
coverage of all or a subset of contraceptive services. Issuers and 
third party administrators providing or arranging payments for 
contraceptive services for participants and beneficiaries in plans of 
eligible organizations would be required to meet the notice 
requirements as set forth in the 2013 final regulations, requiring them 
to provide notice of the availability of separate payments for 
contraceptive services to participants and beneficiaries in the 
eligible organizations' plans (78 FR 39870, 39880 (July 2, 2013)).
    The interim final regulations titled ``Coverage of Certain 
Preventive Services Under the Affordable Care Act'' (79 FR 51092) 
continue to allow eligible organizations that have religious objections 
to providing contraceptive coverage to notify an issuer or third party 
administrator using EBSA Form 700, as set forth in the 2013 final 
regulations. In addition, these interim final regulations permit an 
alternative process under which an eligible organization may notify HHS 
of its religious objection to coverage of all or a subset of 
contraceptive services.
    Form Number: CMS-10535 (OMB control number: 0938-1248); Frequency: 
Once; Affected Public: Private sector (Business or other for-profits 
and not-for-profit institutions); Number of Respondents: 61; Number of 
Responses: 61; Total Annual Hours: 51. (For policy questions regarding 
this collection, contact Usree Bandyopadhyay at 410-786-6650.)

    Dated: March 2, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2015-05165 Filed 3-5-15; 8:45 am]
 BILLING CODE 4120-01-P
```