Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy

Forms and Documents

Document Name	Status
Form CMS-10199 Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy Form	New
Form CMS-10199 Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy Instruction	New
CMS-10199.Supporting Statement.doc Supporting Statement A	2006-09-11

IC Document Collections

IC ID	Document Title	Status
45536	Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy Form	New
45535	Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy Instruction	New

ICR Details

OMB Control No: 0938-1011	ICR Reference No: 200610-0938-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy
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: 01/09/2007
	Date Received in OIRA: 10/04/2006
Terms of Clearance: Approved consistent with memo dated 1/5/2007.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2010	36 Months From Approved
Responses	1,000	0	0
Time Burden (Hours)	500	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: To encourage responsible and appropriate use of CAS with embolic protection, CMS issued a Decision Memo for Carotid Artery Stenting on March 17, 2005, indicating that CAS with embolic protection for patients at high risk for carotid endarterectomy and who also have symptomatic carotid artery stenosis > 70% will be covered only if performed in facilities that have been determined to be competent. In accordance with this criteria CMS considers coverage for CAS reasonable and necessary {1862(A)(1)(a) of the Social Security Act}.

---

Authorizing Statute(s): US Code: 42 USC 1395y(a)(1)(a) Name of Law: Exclusions from coverage and Medicare as secondary
  

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:
	71 FR 36099	06/23/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 52079	09/01/2006
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
Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy	CMS-10199, CMS-10199, CMS-10199	CMS-10199.CAS Data Element List ,   CMS-10199.stent data entry ,   CMS-10199.stent data entry
Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy	CMS-10199, CMS-10199, CMS-10199, CMS-10199	CMS-10199.CAS Data Element ,   CMS-10199.CAS Data Element List ,   CMS-10199.stent data entry ,   CMS-10199.stent data entry

---

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	1,000	0	0	1,000	0	0
Annual Time Burden (Hours)	500	0	0	500	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 program.

---

Annual Cost to Federal Government: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 09/12/2006

---