Carotid Stenting Coverage Policies
CAS in Post-Approval Extension Studies
CAS Coverage Outside of Studies
Commercial Coverage Policies / Other Third-Party Payers
Medicare (CMS) Coverage
CMS coverage of carotid artery stenting (CAS) began in July 2001 when coverage of CAS was limited to patients enrolled in an IDE trial. Since that time, CMS has published multiple related coverage policies for carotid artery stenting. Policies cover CAS in an IDE investigational trial setting, in a post-approval trial setting, in a post-approval extension trial setting, and for a subset of FDA-approved indications, there is coverage outside of trials. Please view the CMS national coverage decision for additional information.
Please note: Carotid artery stenting without embolic protection is considered a non-covered service by Medicare. CMS issued a transmittal on August 25, 2006 clarifying coverage and billing information for carotid artery stenting. In this update, CMS indicated that carotid stenting without embolic protection was a non-covered service, effective March 17, 2005. For additional information, please refer to MLN Matters article 5022.
This section does not include information related to Medicaid coverage. Please check with your local state Medicaid program for coverage information.
CMS Coverage in IDE trials
Effective July 1, 2001, Medicare will cover PTA of the carotid artery concurrent with carotid stent placement when furnished in accordance with the Food and Drug Administration (FDA) approved protocols governing Category B Investigational Device Exemption (IDE) clinical trials. PTA of the carotid artery, when provided solely for the purpose of carotid artery dilation concurrent with carotid stent placement, is considered to be a reasonable and necessary service when provided in the context of such a clinical trial, and therefore is considered a covered service for the purposes of these trials.
Click here to view the full decision memo for this policy
Post-Approval Trials
The FDA approved the Rx Acculink Carotid Stent System and cleared the Rx Accunet Embolic Protection System in August, 2004. FDA approval and clearance of the Xact Carotid Stent System and Emboshield Embolic Protection System came in September 2005. Carotid artery stenting provides a less invasive treatment alternative to conventional open carotid artery surgery for patients who are considered to be at high surgical risk. The device systems are no longer "investigational." However, the FDA required continued data collection on approved indications. All of the criteria below must be met in order for patients enrolled in a post-approval study to be eligible for CMS coverage. More information can be found in the CMS national coverage policy.
Patients enrolled in post-approval trials such as CAPTURE and EXACT are covered when the following criteria are met:
- Patients must be considered high-risk for surgery. This determination is made by the treating physician. More information on high-risk can be found in the CMS national coverage policy.
- Patients must be treated with an FDA-approved device and within the FDA-approved indications.
- Patients must be present with symptomatic stenosis of ≥ 50%, or asymptomatic stenosis of ≥ 80% (as verified by angiography).
Note: Treating facilities and physicians require local Medicare approval to submit claims for patients enrolled in post-approval studies.
Additional Policy Information can be viewed at the following links:
- Decision Memo for Post-Approval CAS Trials (Administrative File: CAG#000259N)
- FDA Subpart E — Post-Approval Requirements for Medical Devices
CMS Policy instructions are included in:
CAS in Post-Approval Extension Studies
In May 2006, CMS released transmittal 951 which discusses coverage of post-approval extension studies. CMS coverage of post approval extension studies follows a similar process to that for post-approval studies. Patient eligibility for coverage is the same: patients must meet specific criteria, must be treated with an FDA-approved device and treated within FDA-approved indications. Study sites must gain local CMS approval in order to submit claims for CMS patients who meet coverage criteria and are enrolled in a post-approval extension study.
See the section above on post-approval study coverage for additional information on coverage criteria. Click here to view CMS Transmittal 951. You may also view MLN Matters article 5088 – Post-Approval Extension Studies.
CAS Coverage Outside of Studies
In March, 2005, CMS expanded coverage to allow patients to be treated without the requirement of enrollment in a clinical trial. Medicare identified a subset of patients (within the FDA-approved indications for carotid stenting) that were eligible to be covered for carotid stenting outside of trials. Specifically, this patient group must meet the following criteria: patients must be high-risk for surgery, and have symptomatic stenosis of ≥ 70%, verified by angiography. This coverage policy came with additional requirements. CMS stated that all facilities must be listed on the CMS Approved Carotid Stenting Facilities Website, all facilities must collect data on carotid stenting cases performed at the site, and the facility must have a clear program for physician credentialing. For a additional information, view the links below:
Commercial Coverage Policies / Other Third-Party Payers
Commercial coverage varies regionally and significantly; from non-coverage of carotid stenting, to coverage of all FDA-approved indications, to coverage only with prior approval.
For commercial coverage, payment and reimbursement information, Abbott Vascular recommends that providers verify insurance coverage prior to procedures.
Listed below are links to several positive coverage policies for carotid artery stenting.
Note: Coverage may be subject to change frequently and without prior notification.
References:
Centers for Medicare and Medicaid Services at www.cms.hhs.gov
ICD-9-CM for Hospitals – Volumes 1,2 & 3; 2006 Professional; 6th edition; edited by Anita C. Hart, RHIA, CCS, CCS-P, Catherine A. Hopkins, Beth Ford, RHIT, CCS; Ingenix
CPT® is a trademark of the American Medical Association.
Current Procedure Terminology (CPT®) is copyright 2005. American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use.
American Medical Association. Current Procedural Terminology (CPT®) 2005. Professional Edition. Chicago, IL: 2005.
Last Updated August 2006
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