(CMS–10531) Transcatheter Mitral Valve Repair (TMVR) National Coverage Decision (NCD)

Forms and Documents

Document Name	Status
Form CMS-10531 KCCQ-10 Form Form and Instruction	Modified
Form CMS-10531 TVT Registry form for TMVR Form and Instruction	Modified
CMS-10531 Supporting Statement - Part A 04-19-18.docx Supporting Statement A	2018-07-16

IC Document Collections

IC ID	Document Title	Status
215705	KCCQ-10 Form Form and Instruction	Modified
215704	TVT Registry form for TMVR Form and Instruction	Modified

ICR Details

OMB Control No: 0938-1274	ICR Reference No: 201807-0938-003
Status: 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
	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

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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.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
TVT Registry form for TMVR	CMS-10531	TVT Registry
KCCQ-10 Form	CMS-10531	KCCQ-10

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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.

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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

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Common Form ICR:  No

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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

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