Carotid Stenting Activities Update from Government Relations Committee

Over the last several months SVS has developed a multi-faceted strategy to address the emerging issues related to carotid stenting.  Among these activities are the following:

SVS participated in FDA panel hearings regarding appropriate indications for use of percutaneous carotid intervention with distal embolic protection;

SVS led CPT and RUC deliberations regarding coding and relative values for transcatheter placement of intravascular stents, with and without embolic protection;

SVS participated in hearings regarding CMS coverage decisions for percutaneous transluminal angioplasty of the carotid artery; 

SVS met with CMS and FDA to promote a vascular-led post-market outcomes data collection initiative; 

The SVS Endovascular Committee has developed draft guidelines for credentialing in percutaneous carotid intervention, which served as the basis for SVS participation in two multi-specialty credentialing documents; 

SVS is conducting a member survey to determine the current levels of training and competence among vascular surgeons for catheter-based interventions; 

SVS has initiated a series of CME-approved courses in cerebral angiography, with the first course scheduled in early December 2004;

SVS has begun an endovascular training opportunities clearinghouse.

SVS participated in the April 2004 meeting of the FDA Circulatory System Devices Panel.  Dr. Green’s comments focused on articulating which patients are best served by carotid stenting and urged FDA to support additional trials with expanded indications.

In his written comments, the following criteria were offered regarding the characteristics of patients who would benefit from carotid stenting: 

 …contralateral laryngeal nerve palsy, a history of radiation therapy to the neck, previous carotid endarterectomy  with recurrent stenosis, and those with medical co-morbidities that might adversely affect the outcome in the opinion of the surgeons, interventionalists and anesthesiologists responsible for the patient. We believe however that this cohort and the patients in the SAPPHIRE represent a small percentage of those in the general population currently undergoing carotid endarterectomy and that this study is not reflective of current national practice.  SVS supports judicious use of CAS in bona fide “high-risk” patients.

Dr. Green also advocated multi-specialty coordination and cooperation and suggested that carotid stenting:

should be performed by those operators with expertise not just on technical aspects of delivering a stent to a target, but in all the pre- and post-procedure components that carotid endarterectomy required. 

On August 31, the FDA approved the Guidant stent and protection device for use in treating carotid artery blockages.  The device is approved for use in patients who are at “high risk” for carotid endarterectomy, and who have had lateralizing cerebrovascular symptoms and a stenosis of at least 50% by angiography or duplex ultrasound.  The FDA also approved this device for asymptomatic patients whose carotid artery is at least 80 percent stenotic by angiogram or duplex ultrasound, and who are also “high-risk” candidates for carotid endarterectomy.

Other companies are also in line for approval:  Cordis received conditional approval by the FDA for a carotid stent / embolic protection device system, but Cordis cannot begin selling this system until the company’s factories are inspected and approved.  Boston Scientific expects approval for its device next year.  Bard and Abbot also have devices in the works.

Earlier this year SVS helped lead a multi-specialty application to the AMA CPT Editorial panel to convert the current Category III carotid stent CPT codes to Category I status.  Two Category I codes were approved, one for transcatheter placement of intravascular stent with embolic protection, another for carotid stent without embolic protection.  These codes have received tentative approval for entry into the 2005 CPT manual.

SVS led the effort to create and analyze the RUC survey data submitted by SVS, ACC, SIR, AANS and AAN.  The RUC reviewed the summary recommendations in late April, and after intense discussion approved the recommendation made by the coalition of societies.  The RUC recommendation for physician work RVUs turned out to be very close to carotid endarterectomy.  The RUC sent its RVU recommendations to CMS this past summer.  Final physician work, practice expense, and malpractice RVUs are determined by CMS and will be published in the Federal Register during the first week of November.

SVS, ACC, ACR, AANS and SIR sent a letter to CMS in February regarding coverage for carotid stenting.  The letter supports coverage only for symptomatic patients who are at high risk for CEA, and divides high risk into two categories: 

The first category includes the anatomic criteria as described in SAPPHIRE data.

For other high risk patients, the letter suggested a collaborative decision-making process that includes multiple physicians and surgeons who performs CEA to establish the risk level for CEA prior to offering carotid stenting. 

SVS individually sent a subsequent letter in mid-July reinforcing support for expanded covered to Medicare beneficiaries in certain high-risk categories for patients:

“whom carotid stenting is proven equivalent to CEA, and where we believe both hold superiority over medical therapy, based on data collected under the auspices of the SAPPHIRE, CREST and CARESS trials.  For normal-risk patients, we believe it is absolutely crucial to withhold coverage until prospective randomized studies such as CREST have tested the equivalence of carotid stenting to CEA.”

The July letter specifically cited categories of patients wherein SVS felt inadequate data had been collected to justify carotid stenting (letter attached).

Several representatives from SVS participated in an August 17 CMS Open Forum.  Included in the SVS comments were the following suggested training and credentialing elements:

physician demonstrates primary clinical responsibility for the management of carotid occlusive disease in 50 patients;

physician has expertise in endovascular management and is qualified to perform endovascular surgery using public guidelines;

physician obtains additional training by performing carotid stenting cases as demonstrated by 30 carotid arteriograms (15 as primary operator); carotid arteriograms performed at the time of carotid stent placement may be counted toward arteriogram requirement; 25 carotid stents (13 as primary operator);

physician completes any FDA mandated training for any specific stent/cerebral protection device combination.

On September 1 CMS announced its intention to cover carotid stenting in FDA required post-approval studies.  CMS will pay for the procedures done during the Guidant FDA-mandated post-market study, which includes high risk patients with symptoms and a 50% or worse stenosis identified by angiogram or ultrasound, and for high risk patients without symptoms, but with a 80% or worse stenosis identified by angiogram or ultrasound.

CMS is also developing their carotid stent coverage policy for patients at high risk for CEA to be implemented outside the auspices of the post-approval studies.  In essence, this will be the policy CMS impose for general use of carotid stenting.  This final CMS review, which will involve public comment on a draft coverage decision, is scheduled to be completed in early 2005.