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Carotid Artery Stenting Facility Recertification Process

As of October 1, 2015, each facility must sign a Business Associate Privacy Agreement as part of the Carotid Artery Stenting (CAS) recertification process.  The agreement is between your facility and Fu Associates, Ltd., the company that maintains CAS data for the Centers for Medicare & Medicaid Services (CMS) for recertification purposes.   Once signed, the agreement will remain in effect through September 13, 2018.  Each facility will receive an e-mail from Fu Associates (via EchoSign); the e-mail will contain a link to the agreement form, which must be signed electronically.   A sample of the form is available below in the DOWNLOADS section, but this is for information purposes only. 

Overview and Background

The Centers for Medicare & Medicaid Services (CMS) has developed this plan to serve as the facility recertification process for facilities that have been approved by CMS to perform carotid artery stenting (CAS). The national coverage determination (NCD) for carotid artery stenting requires, as a condition of coverage, that all facilities be certified by CMS to perform CAS procedures.  To become initially certified, facilities submit a written affidavit attesting that they meet the minimum standards outlined in the NCD.  These standards include physician training, facility device inventory and support, and data collection to evaluate outcomes during a required reevaluation period.  The NCD also states that facilities will be expected to submit data to CMS upon request, and internal analysis of these data should occur no less than every six months.  Recertification is required every two years and must be achieved by following this two-step process — Affidavit and Data Submission.  Upon review of submitted data elements, each facility will either maintain certification or no longer be certified by CMS to perform CAS procedures.  Facilities that do not maintain certification will no longer be eligible for Medicare reimbursement for these services.

Step One — Affidavit

To become initially certified, facilities must submit a written affidavit attesting that they meet the minimum standards outlined in the NCD (Pub. 100-3, 20.7).  The following link provides information relevant to the NCD and the affidavit process:

Facilities must submit a written affidavit to be recertified describing how the facility continues to meet each of the standards specified in the NCD.  CMS must receive the first affidavit for recertification no later than 24 months after each facility's initial effective date.  Subsequent affidavits must be submitted to CMS every two years thereafter.  Failure to submit an affidavit will result in nonpayment for future CAS procedures.

For questions concerning the affidavit process or CMS-related policy issues, please contact:

Step Two — Data Submission

Data from all procedures performed within 24 months of each facility's effective date must be submitted to CMS no later than 27 months after the effective date.  Following each facility's initial data submission, data must be submitted twice a year, on April 1 and October 1.  The April 1, 2015 submission is for data from procedures performed beginning the day after a facility's two-year initial certification period through December 31, 2014. For example, a facility with an initial effective date of July 15, 2012 that has submitted its initial two years of data is required to submit data from procedures performed on July 16, 2014 through December 31, 2014, and to submit it no later than April 1, 2015. The next submission deadline would be October 1, 2015 and must include data from procedures performed on January 1, 2015 through June 30, 2015.  The next submission, on April 1, 2016, must include data from July 1, 2015 through December 31, 2015.  This schedule provides facilities with three months — from the last procedure date until the submission due date — to assemble and format data for submission.  See the CAS Submission Timeline below.

CAS Data Submission Timeline

Facilities that do not perform any CAS procedures during a six-month reporting period (January 1 through June 30, or July 1 through December 31) should not submit any information.  Please do not submit a blank CD or any type of notification if no CAS procedures were performed.  Facilities should only submit data when CAS procedures are performed during the six-month reporting period.  Submissions will continue to follow this schedule unless new instructions are posted to this website.

The updated "CAS Data Entry and Submission Instructions" and "CAS Submission Spreadsheet" can be downloaded via the link under Downloads below.

For questions concerning data submission, please contact the CAS Helpdesk: