Carotid Stenting Coverage Policies

• Medicare (CMS) Coverage
• CMS Coverage - Concurrent with Carotid Stent Placement in Food and Drug Administration (FDA) – Approved Category B Investigational Device Exemption (ICE) Clinical Trials
• CMS Coverage – Concurrent with Carotid Stent Placement in FDA-Approved Post-Approval Studies
• 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 determination for additional information. To link to the official CMS coverage determination access the web at www.cms.gov and select the following links: Medicare, Medicare Coverage – General Information, Coverage Center, NCDs, Percutaneous Transluminal Angioplasty (PTA).

Please note: Effective December 9, 2009 Medicare clarified coverage for carotid artery stenting requiring the use of an FDA-approved or cleared embolic protection device. Medicare clarified if deployment of the embolic protection device is not technically possible, and not performed, then the procedure is not covered by Medicare.¹

This section does not include information related to Medicaid coverage. Please check with your local state Medicaid program for coverage information.

CMS Coverage - Concurrent with Carotid Stent Placement in Food and Drug Administration (FDA) – Approved Category B Investigational Device Exemption (IDE) Clinical Trials¹

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.

To link to the official CMS coverage determination access the web at www.cms.gov and select the following links: Medicare, Medicare Coverage – General Information, Coverage Center, NCDs, Percutaneous Transluminal Angioplasty (PTA).

CMS Coverage – Concurrent with Carotid Stent Placement in FDA-Approved Post-Approval Studies¹

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 requires continued data collection on approved indications. All of the coverage criteria must be met in order for patients enrolled in a post-approval study to be eligible for CMS coverage. Treating facilities and physicians require local Medicare approval to submit claims for patients enrolled in post-approval studies.

Detailed coverage requirements can be found in the CMS national coverage policy. To link to the official CMS coverage determination access the web at www.cms.gov and select the following links: Medicare, Medicare Coverage – General Information, Coverage Center, NCDs, Percutaneous Transluminal Angioplasty (PTA).

CAS in Post-Approval Extension Studies

In May 2006, CMS released a transmittal addressing 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 obtain local CMS approval in order to submit claims for CMS patients who meet coverage criteria and are enrolled in a post-approval extension study.

The official Medicare transmittal 951, Payment for Carotid Artery Stenting (CAS) Post-Approval Extension Studies dated May 12, 2006 can be accessed at the following link: http://www.cms.gov/transmittals/downloads/R951CP.pdf

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 carotid endartectomy (CEA) surgery, and have symptomatic carotid artery stenosis of ≥ 70%. This coverage policy contains important additional requirements. To view the official CMS coverage determination access the web at www.cms.gov and select the following links: Medicare, Medicare Coverage – General Information, Coverage Center, NCDs, Percutaneous Transluminal Angioplasty (PTA).

CMS requires that all facilities must be evaluated and listed on the CMS Approved Carotid Stenting Facilities Website http://www.cms.gov/MedicareApprovedFacilitie/CASF/list.asp. For information specific to obtaining certification please access the web at www.cms.gov and select the following links: Medicare, Medicare Coverage – General Information, Coverage Center, NCDs, Percutaneous Transluminal Angioplasty (PTA).

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 performing procedures.

¹ Center for Medicare and Medicaid Services (CMS), Pub 100-3 Medicare National Coverage Determinations, Transmittal 115, March 5, 2010. http://www.cms.gov/transmittals/downloads/R115NCD.pdf

References:

Centers for Medicare and Medicaid Services at www.cms.gov

ICD-9-CM for Hospitals – Volumes 1, 2 & 3; 2010 Professional; 6th edition; edited by Anita C. Hart, RHIA, CCS, CCS-P, Melinda S. Stegman, MBA, CCS, Beth Ford, RHIT, CCS; Ingenix

CPT® is a trademark of the American Medical Association.

Current Procedure Terminology (CPT®) is copyright 2009. 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®) 2010. Professional Edition. Chicago, IL.

Last Updated July 2010

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