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OMB Control No: 0938-1011	ICR Reference No: 202008-0938-012
Status: Historical Active	Previous ICR Reference No: 201704-0938-007
Agency/Subagency: HHS/CMS	Agency Tracking No: 20636
Title: (CMS-10199) Data Collection for Medicare Beneficiaries Receiving Carotid Artery Stenting with Embolic Protection
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/04/2021
	Date Received in OIRA: 08/14/2020
Terms of Clearance: In CMS' next reinstatement, revision, or extension request, CMS shall add the information required by 5 CFR 1320.8(b)((3)(iv) and (v). CMS shall also include a copy of guidance or instructions in effect related to this collection of information, if any. The Business Associate Agreement included in this submission is not covered by the Paperwork Reduction Act (5 CFR 1320.3(h)(1)).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2024	36 Months From Approved	03/31/2021
Responses	4,260	0	4,110
Time Burden (Hours)	30,057	0	28,998
Cost Burden (Dollars)	0	0	0

Abstract: To encourage responsible and appropriate use of Carotid Artery Stenting (CAS) with embolic protection, CMS issued a Decision Memo for Carotid Artery Stenting on March 17, 2005. As a result, Medicare covers PTA of the carotid artery concurrent with the placement of an FDA-approved carotid stent with embolic protection for the following: •Patients who are at high risk for CEA and who also have symptomatic carotid artery stenosis >70 %. Coverage is limited to procedures performed using FDA-approved carotid artery stenting systems and FDA-approved or -cleared (effective December 9, 2009) embolic protection devices. If deployment of the embolic protection device is not technically possible, and not performed, then the procedure is not covered by Medicare (effective December 9, 2009); •Patients who are at high risk for CEA [Carotid Endarterectomy] and have symptomatic carotid artery stenosis between 50 % and 70 %, in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (Medicare NCD Manual 310.1), or in accordance with the NCD on carotid artery stenting (CAS) post-approval studies (Medicare NCD Manual 20.7); •Patients who are at high risk for CEA and have asymptomatic carotid artery stenosis >80 %, in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (Medicare NCD Manual 310.1), or in accordance with the NCD on CAS post- approval studies (Medicare NCD Manual 20.7).

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:
	85 FR 34735	06/08/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 49654	08/14/2020
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	4,260	4,110	150
Annual Time Burden (Hours)	30,057	28,998	1,059
Annual Cost Burden (Dollars)	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: Changes in burden are the result of the increase in the BLS mean hourly wage and an increase in the number of facilities approved by CMS to perform CAS procedures. The burden has increased from 28,998 hours at $1,127,456 to 30,057 hours at $1,271,998.

Annual Cost to Federal Government: $114,507

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? No

Agency Contact: Denise King 410 786-1013 Denise.King@cms.hhs.gov

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