(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	New
Form CMS-10531 TVT Registry form for TMVR Form and Instruction	New
TMVR PRA Final Support- Part A Final 1014.docx Supporting Statement A	2015-03-17

IC Document Collections

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

ICR Details

OMB Control No: 0938-1274	ICR Reference No: 201503-0938-008
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: (CMS–10531) Transcatheter Mitral Valve Repair (TMVR) National Coverage Decision (NCD)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/08/2015
	Date Received in OIRA: 03/18/2015
Terms of Clearance: The approved forms must contain the following: 1) expiration date, 2) OMB control number, and 3) PRA burden statement.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved
Responses	5,200	0	0
Time Burden (Hours)	5,600	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:
	79 FR 73891	12/12/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 12180	03/06/2015
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
TVT Registry form for TMVR	CMS-10531	TVT Registry
KCCQ-10 Form	CMS-10531	KCCQ-10

---

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	5,200	0	0	5,200	0	0
Annual Time Burden (Hours)	5,600	0	0	5,600	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

---

Annual Cost to Federal Government: $3,055

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

---

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: 03/18/2015

---