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Your Carotid Stent Coverage Dreams Are Coming True

Published on Sun Sep 19, 2004

Guidant gets approval, and you'll get new CPT codes
 
You can expect new CPT codes for carotid stents to be released in November and put into effect Jan. 1.
   
The U.S. Food and Drug Administration (FDA) approved Guidant Corporation's RX ACCULINK Carotid Stent System and cleared RX ACCUNET Embolic Protection System on Aug. 31. Both devices provide minimally invasive treatment alternatives to high-risk surgical patients.
  
Since 2001, CMS has only covered carotid artery stenting in clinical trials of investigational products the FDA has not yet approved. Recognizing that the FDA-required postapproval trial would not be covered under Investigational Device Exemption (IDE) regulations, the agencies worked together for a quick solution.
 
"Coverage for our carotid postapproval study is a huge result of a joint effort by the FDA and CMS," says Linda Dickes, the reimbursement and economics manager of Guidant Corporation in Santa Clara, Calif.
 
You should recognize the following key points, Dickes says:

 
  • Until CMS' national policy changes, CMS will not cover carotid stents except in IDE trials. CMS has stated that the expanded coverage will be implemented as quickly as possible following the mandatory 30-day comment period (ends Oct. 1, 2004). 
     
  • CMS doesn't know exactly how the implementation will occur. The implementation rules will be at the local contractors' discretion. However, CMS indicates that quick implementation could be accomplished. How? By following IDE trial regulations and only substituting another type of number to identify the trial.
     
  • You may find that other insurers will cover carotid artery stents when the cardiologist uses an FDA-approved device. For example, Aetna already has a national coverage policy.
     
  • Hospitals will receive new ICD-9 procedure codes Oct.1, but you'll have your new CPT codes in November.
               
    Keep in mind: Every company obtaining an FDA-approved carotid stent and embolic protection device must conduct a postmarket study to "assess real-world physician experience with this important new therapy," says Bev Huss, endovascular solutions president of Guidant in Indianapolis.

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