[Federal Register Volume 83, Number 69 (Tuesday, April 10, 2018)]
[Notices]
[Pages 15389-15390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07247]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10531 and CMS-R-43]


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 the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected, and the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

DATES: Comments must be received by June 11, 2018.

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' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    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: William Parham at (410) 786-4669.

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

[[Page 15390]]

and associated materials (see ADDRESSES).

CMS-10531 Transcatheter Mitral Valve Repair (TMVR) National Coverage 
Decision (NCD)
CMS-R-43 Conditions of Coverage for Portable X-ray Suppliers and 
Supporting Regulations

    Under the 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: Revision of a currently 
approved collection; 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. In order to remove the data collection requirement under this 
coverage with evidence development (CED) NCD or make any other changes 
to the existing policy, we must formally reopen and reconsider the 
policy. We are continuing to review and analyze the data collected 
since this NCD was effective in 2014.
    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 collected and analyzed in the TVT Registry will be used by 
CMS to determine if the TMVR is reasonable and necessary (e.g., 
improves health outcomes) for Medicare beneficiaries under section 
1862(a)(1)(A) of the Act. 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. Form Number: CMS-
10531 (OMB control number: 0938-1274); Frequency: Annually; Affected 
Public: Private sector (Business or other for-profits); Number of 
Respondents: 3,897; Total Annual Responses: 15,588; Total Annual Hours: 
5,456. (For policy questions regarding this collection contact Sarah 
Fulton at 410-786-2749.)
    2. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Conditions of Coverage for Portable X-ray Suppliers and 
Supporting Regulations; Use: The requirements contained in this 
information collection request are classified as conditions of 
participation or conditions for coverage. Portable X-rays are basic 
radiology studies (predominately chest and extremity X-rays) performed 
on patients in skilled nursing facilities, residents of long-term care 
facilities and homebound patients. The CoPs are based on criteria 
described in the law, and are designed to ensure that each portable X-
ray supplier has properly trained staff and provides the appropriate 
type and level of care for patients. We use these conditions to certify 
suppliers of portable X-ray services wishing to participate in the 
Medicare program. This is standard medical practice and is necessary in 
order to help to ensure the well-being, safety and quality professional 
medical treatment accountability for each patient. There is a 
significant increase in the burden due to burden that was not accounted 
for in the previous information collection request. Form Number: CMS-R-
43 (OMB Control number: 0938-0338); Frequency: Yearly; Affected Public: 
Business or other for-profit and Not-for-profit institutions; Number of 
Respondents: 5,986,509; Total Annual Responses: 5,987,018; Total Annual 
Hours: 532,959. (For policy questions regarding this collections 
contact Sonia Swancy at 410-786-8445.)

    Dated: April 4, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2018-07247 Filed 4-9-18; 8:45 am]
 BILLING CODE 4120-01-P