CMS Approved Facilities Website

Carotid Artery Stenting

Effective March 2005, CMS expanded coverage of Carotid artery stenting 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 planed to develop a carotid stenting program and treat patients outside of studies would have to meet additional requirements.

Those requirements are listed below, and summarized as the following:

• 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

Click here to view the list of CMS Approved Carotid Stenting Facilities

The excerpt below is taken from the CMS national coverage policy for PTA which includes carotid artery stenting.

CMS determined that CAS with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. Standards to determine competency will include specific physician training standards, facility support requirements, and data collection to evaluate outcomes during a required reevaluation

The CMS created a list of minimum standards modeled in part on professional society statements on competency. All facilities must at least meet CMS’s standards in order to receive coverage for CAS for high risk patients. An affidavit must be submitted to CMS indicating that the following minimum standards have been met, or that the facility has been a participant in an FDA-approved carotid stenting trial such as: SAPPHIRE or ARCHER.

A new affidavit will be required every two years to ensure that facilities maintain high standards.

• Facilities must have necessary imaging equipment, device inventory, staffing, and infrastructure to support a dedicated carotid stent program. Specifically, high-quality X-ray imaging equipment is a critical component of any carotid interventional suite, such as high resolution digital imaging systems with the capability of subtraction, magnification, road mapping, and orthogonal angulation.
• Advanced physiologic monitoring must be available in the interventional suite. This includes real time and archived physiologic, hemodynamic, and cardiac rhythm monitoring equipment, as well as support staff who are capable of interpreting the findings and responding appropriately.
• Emergency management equipment and systems must be readily available in the interventional suite such as resuscitation equipment, a defibrillator, vasoactive and antiarrhythmic drugs, endotracheal intubation capability, and anesthesia support.
• Each institution should have a clearly delineated program for granting carotid stent privileges and for monitoring the quality of the individual interventionalists and the program as a whole. The oversight committee for this program should be empowered to identify the minimum case volume for an operator to maintain privileges, as well as the (risk-adjusted) threshold for complications that the institution will allow before suspending privileges or instituting measures for remediation. Committees are encouraged to apply published standards from national specialty societies recognized by the American Board of Medical Specialties to determine appropriate physician qualifications. Examples of standards and clinical competence guidelines include those published in the December 2004 edition of the American Journal of Neuroradiology, and those published in the August 18, 2004, Journal of the American College of Cardiology.
• To continue to receive Medicare payment for CAS under this decision, the facility or a contractor to the facility must collect data on all CAS procedures done at that particular facility. This data must be analyzed routinely to ensure patient safety, and will also be used in the process of re-credentialing the facility. This data must be made available to CMS upon request. The interval for data analysis will be determined by the facility but should not be less frequent than every 6 months.

Since there currently is no recognized entity that evaluates CAS facilities, CMS established a mechanism for evaluating facilities. Facilities must provide written documentation to CMS that the facility meets one of the following:

• The facility was an FDA-approved site that enrolled patients in prior CAS IDE trials, such as SAPPHIRE, and ARCHER;
• The facility is an FDA-approved site that is participating and enrolling patients in ongoing CAS IDE trials, such as CREST;
• The facility is an FDA-approved site for one or more FDA post-approval studies; or,
• The facility has provided a written affidavit to CMS attesting that the facility has met the minimum facility standards. This should be sent to:

  Director, Coverage and Analysis Group
  7500 Security Boulevard, Mailstop C1-09-06
  Baltimore, MD 21244.

  The letter must include the following information:

  • Facility's name and complete address;
  • Facility's Medicare provider number;
  • Point-of-contact for questions with telephone number;
  • Mechanism of data collection of CAS procedures; and,
  • Signature of a senior facility administrative official.

A list of approved facilities will be made available and viewable at http://www.cms.hhs.gov/MedicareApprovedFacilitie/CASF/list.asp. In addition, CMS will publish a list of approved facilities in the Federal Register. A new affidavit is required every two years to ensure that facilities maintain high standards

• Template for Facilities that have participated in carotid stent studies
• Template for Facilities that have NOT participated in carotid stent studies

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