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
[PDF, 1.30MB] from the first 30-day public comment period are now available for viewing.
December 17, 2004
Instructions for submitting public comments are available at http://www.cms.hhs.gov/coverage/8h.asp
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