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

OMB 0938-1011

OMB 0938-1011

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).

The latest form for (CMS-10199) Data Collection for Medicare Beneficiaries Receiving Carotid Artery Stenting with Embolic Protection expires 2021-01-31 and can be found here.

OMB Details

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

Federal Enterprise Architecture: Health - Health Care Services

Form CMS-10199CMS-10199.stent data entryFillable FileableForm

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.


© 2024 OMB.report | Privacy Policy