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Find reimbursement resources, including coding guides, links to Medicare Coverage Determinations, on-demand webinars, and frequently asked questions for products used for carotid artery stenting.

 

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Carotid Artery Stenting

Providers should consult with their payers regarding appropriate documentation, medical necessity and coding information consistent with individual payer requirements and policies.

Medicare and Commercial Payer Coverage

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.

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

In September 2014, CMS granted approval for Percutaneous Transluminal Angioplasty (PTA) to cover carotid artery stenting through the CREST-2 trial and the CREST-2 Registry. Please view the CMS national coverage determination for additional information.

 

CREST-2

(Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial)

CREST-2, sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH), is intended to evaluate the best approach for managing asymptomatic patients with high-grade carotid atherosclerotic stenosis. This prospective multi-center randomized controlled trial started enrollment in 2014 and is expected to complete final data collection for primary outcome measure in 2020. CREST-2 site selection and credentialing is managed by a multi-disciplinary committee. Please visit the NIH StrokeNet web site or the CREST-2 Trial web site for additional information.

 

CREST-2 Registry (C2R)

The objective of CREST-2 Registry is to promote the rapid initiation and completion of patient enrollment in the CREST-2 trial. Accreditation for Cardiovascular Excellence (ACE) was selected by CMS to accredit C2R clinical sites.

National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry and Society for Vascular Surgery’s Vascular Quality Initiative (VQI) are the selected registries to administer C2R data collection. Each C2R participating operator/site is required to have membership for either the NCDR-PVI Registry or the SVS-VQI Registry.

Commercial Coverage Policies / Other Third-Party Payers

Because commercial coverage varies regionally, Abbott 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. https://www.cms.gov

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

CMS-Approved Facilities

Effective March 2005, the Centers for Medicare and Medicaid Services (CMS) expanded coverage of carotid artery stenting (CAS) to patients who were not enrolled in medical device trials (IDE or FDA-required post-approval). With the coverage decision, CMS stated that all facilities who planned to develop a carotid stenting program and treat patients outside of studies would have to meet additional requirements. For detailed information about CMS' coverage policy of carotid stenting procedures, please visit:

https://www.cms.gov

These requirements are summarized below:

  • All facilities shall submit an affidavit attesting to meeting specific minimum standards or attesting that they have participated in an FDA-approved carotid stenting trial (IDE or FDA required post-approval study)
  • Facilities will collect data on all carotid stenting procedures
  • Facilities will have a clear credentialing program for interventionalists performing carotid stenting

View the list of CMS Approved Carotid Stenting Facilities at the CMS website.

Carotid Stenting Prior Authorization Toolkit

Abbott offers this Carotid Stenting Prior Authorization Tool Kit for use by physicians and their offices when seeking prior authorization or submitting claims to plans requiring such pre-procedure approvals. This comprehensive tool kit includes information to assist your office in submitting prior authorization requests to private payers to confirm coverage for patients who may benefit from a carotid artery stent (CAS) procedure. Download the guide and the accompanying forms using the links below.

Abbott recommends seeking prior authorization for all cases except those covered by traditional (fee for service) Medicare. Please note, prior authorization is not required for fee for service Medicare patients.

Tool Kit Instructions

Download this guide for submitting prior authorization requests for your patients to private payers. It includes instructions on how to use this tool kit and the associated forms and provides a checklist of the key steps necessary to request authorization.

FDA CAS Approval Letter

Download a copy of the FDA approval letter for the RX Acculink Carotid Stent System. This letter may be required as part of the submission for CAS authorization.

Sample Standard Risk Letter of Medical Necessity

Download a sample letter template that provides suggestions to assist in writing a Letter of Medical Necessity or prior authorization request for the Acculink Carotid Artery Stent System with Accunet Embolic Protection for patients with carotid artery disease at standard surgical risk. Physicians should customize the letter based on the patient’s actual medical history and diagnosis, and to be consistent with any specific payer requirements.

Sample High Risk Letter of Medical Necessity

Download a sample letter template that provides suggestions to assist in writing a Letter of Medical Necessity or prior authorization request for the Acculink Carotid Artery Stent System with Accunet Embolic Protection for patients with carotid artery disease at high surgical risk. Physicians should customize the letter based on the patient’s actual medical history and diagnosis, and to be consistent with any specific payer requirements.

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HE&R Disclaimer

This document and the information contained herein is for general information purposes only and is not intended, and does not constitute, legal, reimbursement, business, clinical, or other advice. Furthermore, it is not intended to and does not constitute a representation or guarantee of reimbursement, payment, or charge, or that reimbursement or other payment will be received. It is not intended to increase or maximize payment by any payer. Similarly, nothing in this document should be viewed as instructions for selecting any particular code, and Abbott does not advocate or warrant the appropriateness of the use of any particular code. The ultimate responsibility for coding and obtaining payment/reimbursement remains with the customer. This includes the responsibility for accuracy and veracity of all coding and claims submitted to third-party payers. In addition, the customer should note that laws, regulations, and coverage policies are complex and are updated frequently, and, therefore, the customer should check with its local carriers or intermediaries often and should consult with legal counsel or a financial, coding, or reimbursement specialist for any questions related to coding, billing, reimbursement or any related issues. This material reproduces information for reference purposes only. It is not provided or authorized for marketing use.

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