HCFA to Cover Carotid PTA/Stent Deployment in Clinical Trials
Published on Sun Apr 01, 2001
HCFA has decided to cover balloon angioplasty in the carotid artery performed with the deployment of a carotid stent during approved clinical trials. Although payment decisions for these procedures remain carrier-driven, the March 20 HCFA decision (Medicare Coverage Policy Decision #CAG 00085A) is a signal to Medicare carriers that payment of carotid percutaneous transluminal angioplasty (PTA)/stents, until now explicitly not covered, should be reconsidered in light of growing medical evidence.
Deployment of a carotid PTA/stent will be covered when this procedure is performed in accordance with a Food and Drug Administration (FDA) approved category B Investigational Device Exemption (IDE) trials.
The carotid artery is the principal vessel supplying the head and neck with blood. Accumulation of plaque in this vessel can lead to stroke either by decreasing the blood flow to the brain or by plaque breaking free and lodging in the brain or in other arteries to the head. The PTA is performed to open the narrowed portion of the vessel. The stent is then deployed to provide structural support, says Marko Yakovlevitch, MD, FACP FACC, a cardiologist in private practice in Seattle.
Until now, carotid PTA/stents were always noncovered services, although some local Medicare carriers may have erroneously or inadvertently paid for the procedures. HCFAs current standard of care for obstructed carotid arteries is carotid endarectomy (35301, thromboendarterectomy, with or without patch graft; carotid, vertebral, subclavian, by neck incision), a surgical procedure that involves opening the artery and manually removing the plaque.
Carotid PTAs specifically were not covered, according to Section 50-32 of the Medicare Coverage Manual (MCM), which currently states, The safety and efficacy of these procedures have not been established.
Any carotid stent deployment in conjunction with a carotid PTA also was not covered. Statute 42CFR405.207 of the Code of Federal Regulations states, Medicare payment is not made for medical and hospital services that are related to the use of a device that is not covered because HCFA determines the device is not reasonable and necessary ... or because it is excluded from coverage for other reasons. These services include all services furnished in preparation for the use of a non-covered device, services furnished contemporaneously with and necessary to the use of a non-covered device, and services furnished as necessary after-care that are incident to recovery from the use of the device or from receiving related non-covered services.
In the decision, HCFA specified section 50-32 of the MCM would be amended to read as follows:
PTA is not covered to treat obstructive lesions of the carotid artery except in the following circumstance;
Medicare will cover PTA of the carotid artery concurrent with stent placement in clinical trials that receive a category B IDE designation [...]
