View Information Collection Request (ICR) Package
Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-1274
ICR Reference No:
201807-0938-003
Status:
Historical Active
Previous ICR Reference No:
201503-0938-008
Agency/Subagency:
HHS/CMS
Agency Tracking No:
Title:
(CMS–10531) Transcatheter Mitral Valve Repair (TMVR) National Coverage Decision (NCD)
Type of Information Collection:
Reinstatement with change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
12/03/2018
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/18/2018
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2021
36 Months From Approved
Responses
15,588
0
0
Time Burden (Hours)
5,456
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
Decision Memorandum CAG#-00438N entitled Transcatheter Mitral Valve Repair (TMVR) for Degenerative Mitral Regurgitation was published August 7, 2014. In this decision, CMS determined that it the evidence is sufficient to cover TMVR under Coverage with Evidence Development for Medicare beneficiaries under certain conditions only when the provider is participating in and patients are enrolled in a qualifying clinical studies meeting certain requirements. Consistent with section 1142 of the Social Security Act, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies that the CMS determines meet specified standards and address the specified research questions.
Authorizing Statute(s):
None
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
83 FR 15389
04/10/2018
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 32667
07/13/2018
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
KCCQ-10 Form
CMS-10531
KCCQ-10
TVT Registry form for TMVR
CMS-10531
TVT Registry
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
15,588
0
0
0
10,388
5,200
Annual Time Burden (Hours)
5,456
0
0
0
-144
5,600
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
The changes to burden are due to calculations based on averages of the actual number of TMVR procedures performed since the original PRA package was created. The original numbers were estimates that were not based on experience as these were new processes at the time and they also did not account for overhead and benefits. The number of respondents decreased from 4,000 to 3,987. The burden hours decreased from 5,600 to 5,456.
Annual Cost to Federal Government:
$3,295
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Denise King 410 786-1013 Denise.King@cms.hhs.gov
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
07/18/2018
An official website of the United States government
The .gov means it's official.
The site is secure.
