(CMS-10199) Data Collection for Medicare Beneficiaries Receiving Carotid Artery Stenting with Embolic Protection

Forms and Documents

Document Name	Status
Form CMS-10199 Business Associate Privacy Agreement Form and Instruction	New
CMS-10199 Supporting Statement Part A Carotid Artery Stenting Data Collection 090117.docx Supporting Statement A	2017-09-05

IC Document Collections

IC ID	Document Title	Status
45535	Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy Instruction	Modified
226553	Business Associate Privacy Agreement Form and Instruction	New

ICR Details

OMB Control No: 0938-1011	ICR Reference No: 201704-0938-007
Status: Active	Previous ICR Reference No: 201309-0938-033
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/25/2017
	Date Received in OIRA: 04/28/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	36 Months From Approved	09/30/2017
Responses	4,110	0	1,000
Time Burden (Hours)	28,998	0	500
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:
	82 FR 11040	02/17/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 19734	04/28/2017
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
Business Associate Privacy Agreement	CMS-10199	BUSINESS ASSOCIATE AGREEMENT
Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy	CMS-10199	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	4,110	1,000	0	1,370	1,740	0
Annual Time Burden (Hours)	28,998	500	0	228	28,270	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: Due to adjustments in these estimates, which were inaccurate due to an error, and the addition of the Business Associate Privacy Agreement requirement to satisfy HIPAA requirements and compliance, the burden has increased from 500 hours at $0 to 28,998 hours at $1,127,456.

---

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? 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: 04/28/2017

---