(CMS-10199) Data Collection for Medicare Beneficiaries Receiving Carotid Artery Stenting with Embolic Protection
Extension without change of a currently approved collection
No
Regular
08/14/2020
Requested
Previously Approved
36 Months From Approved
01/31/2021
4,260
4,110
30,057
28,998
0
0
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).
US Code:
42 USC 1395y(a)(1)(a)
Name of Law: Exclusions from coverage and Medicare as secondary
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.
$114,507
No
No
No
No
No
No
No
Denise King 410 786-1013 Denise.King@cms.hhs.gov
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:
(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;
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.
Form CMS-10199 Business Associate Privacy Agreement
CMS-10199 response to comments.docx
Data Collection for Medicare Facilities Performing Carotid Artery Stenting with Embolic Protection in Patients at High Risk for Carotid Endarterectomy