HCFA to Cover PTA/Stent Deployment in Clinical Trials
Published on Tue May 01, 2001
HCFA has decided to cover balloon angioplasty in the carotid artery performed with 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 carriers that 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 performed in accordance with Food and Drug Administration 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 the carotid artery can lead to stroke, either by decreasing the blood flow to the brain or by having plaque break free and lodge in the brain or other arteries to the head. The PTA is performed to reopen the narrowed portion of the vessel, and the stent is deployed to prevent the artery from closing and also prevent plaque from entering the bloodstream.
Until now, carotid PTA/stents were always noncovered services (although some insurers may have paid for the procedures mistakenly). HCFAs current standard of care for obstructed carotid arteries is carotid endarterectomy (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 are not covered, according to Section 50-32 of the Medicare Coverage Manual, which states, PTA is not covered to treat obstructive lesions of the carotid, vertebral, and cerebral arteries. The safety and efficacy of these procedures have not been established.
Any carotid stent deployment in conjunction with a carotid PTA is also not covered. A statute (42CFR405.207) in 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 noncovered device, services furnished contemporaneously with and necessary to the use of a noncovered device, and services furnished as necessary after-care that are incident to recovery from the use of the device or from receiving related noncovered services.
In the decision, HCFA said that section 50-32 of the Medicare Coverage Manual 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 [...]
