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National Coverage Analysis (NCA) Tracking Sheet

Carotid Artery Stenting

CAG-00085R

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Issue

CMS has received a coverage request to revise our current policy on carotid stents, in order to extend coverage beyond clinical trials to include the population studied in the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial. Currently, Medicare only covers PTA of carotid artery concurrent with stent placement in clinical trials that receive a Category B IDE designation from the FDA. The scope of the coverage request was for carotid stenting with embolic protection in patients at high risk for surgery (carotid endarterectomy).

As part of any National Coverage Analysis, we will undertake a complete review of the available literature concerning carotid stents for this and similar patient populations. This may include a detailed review of other relevant clinical trials including Archer, Beach, Cabernet, CREST, MAVErIC II. Detailed data from completed trials will allow a more timely completion of this NCD.

Completion of this NCD depends both upon publication in a peer-reviewed journal of original clinical trial data pertinent to this request and FDA approval of the technology. Lack of either would likely result in a decision to maintain current coverage.

National Coverage Determinations

Benefit Category

Inpatient Hospital Services
Physicians' Services

Requestor Information

Requestor Name Requestor Letter
Cordis Corporation (Johnson & Johnson) View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
06/18/2004
Expected NCA Completion Date
03/18/2005
Public Comment Period
06/18/2004 - 07/18/2004
Proposed Decision Memo Due Date
Proposed Decision Memo Released
12/17/2004
Proposed Decision Memo Public Comment Period
12/17/2004 - 01/17/2005
Decision Memo Released
03/17/2005
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Rana Hogarth, M.H.S.
Lead Medical Officers
Joe Chin, M.D.

Medicare Benefit Category Determination Date

Actions Taken

June 18, 2004

Reviewed and accepted reconsideration request.

We are interested in comments on each of the trials mentioned above as well as evidence to support the appropriate selection of carotid stents for differing patient populations. Specifically, we request comments on several topics including but are not limited to the definition of patients at "high risk" for carotid endarterectomy, provider qualification and training, the efficacy of embolic protection devices, results from other carotid stenting trials with a high risk population, and evidence of the efficacy and appropriateness of carotid stenting for this target population.

In addition, we are interested in comments on the degree of facility experience required, types of provider training programs to be developed, the rigor of these programs, supporting staff and specialty requirements, and specific stipulations that should be in place to ensure the appropriate use of this procedure in the indicated patient population.

July 2, 2004

On August 17th 2004, CMS is holding a town hall meeting on Potential Facility Qualifications for Carotid Stenting Procedures. Please see meeting notice in Federal Register: June 25, 2004 (Volume 69, Number 122)

August 5, 2004

Comments [PDF, 1.30MB] from the first 30-day public comment period are now available for viewing.

December 17, 2004

CMS is posting a Proposed Decision Memorandum for a 30-day public comment period. CMS is particularly interested in comments on the following

  • Appropriate criteria, comorbid or chronic conditions for defining patients at high risk for CEA
  • Criteria for appropriately defining symptomatic patients
  • Professional and facility standards for performing PTA of the carotid artery with carotid stent placement
  • Evaluation process for providers and facilities
  • CMS decision
Instructions for submitting public comments are available at http://www.cms.hhs.gov/coverage/8h.asp

February 4, 2005

The 30 day public comment period for the Proposed Decision Memorandum has closed. In that memo, CMS proposed to link payment for carotid stenting procedures to facility certification based on criteria developed by nationally recognized accrediting organizations. Facilities that are not certified to perform carotid stenting on high risk patients would not receive payment. CMS is still interested in comments on the implementation and sustainability of a national evaluation process to ensure quality care and patient safety.

March 17, 2005

Final Decision Memorandum posted.
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