General Surgery Coding Alert

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 from the FDA. PTA of the carotid artery, when provided solely for the purpose of dilation concurrent with carotid stent placement, is considered to be a reasonable and necessary service only when provided in the context of such a clinical trial, and therefore is considered a covered service for the purposes of these trials. Although the carotid stent used in this procedure is presently under evaluation as a Category B investigational device, the PTA used to place the stent (and all services related to this procedure) are considered covered services.

Performance of PTA in the carotid artery when used to treat obstructive lesions outside of an approved Category B IDE clinical trial remains a noncovered service.

No Guarantee of Coverage

Despite this decision, carriers still have the authority not to cover carotid PTA/stent procedures, even when performed as a part of an approved IDE trial. Federal regulation 42CFR405.207 (the same law that did not permit payment of the stent as long as the PTA was noncovered) specifies, all services furnished in preparation for the use of a noncovered device also are not covered.

This statute overrides the HCFA policy mandate. Because the carotid stent remains a Category B investigational device, coverage of carotid stent deployment remains at the discretion of the carrier. Should a carrier decide not to cover the stent at this time, the PTA also remains noncovered (even when performed during an approved clinical trial).

However, most carriers routinely cover many B-Category investigational devices, and therefore the PTA/stent will likely be payable if performed during an approved trial.

HCFAs stated purpose for permitting coverage for carotid PTA/stents is to support clinical trials for a promising technique. But, says Jeffrey Kang, MD, director of HCFAs Office of Clinical Standards and Quality and the agencys chief clinical officer, What we learn from this coverage decision also will help us consider this therapy as an alternative for other patients at risk for stroke.

The decision also sends a clear signal to carriers that HCFA is taking another look at its policy on carotid PTA/stents, which could influence more carriers to cover the stent and therefore pay for the combined procedure.

Coding the PTA/Stent

Ironically, although HCFAs decision provides coverage for the carotid PTA, it will likely be bundled with the stent deployment and not be separately payable. Although PTAs and stents performed in the same (noncoronary) vessel are separately payable when a PTA is performed and a decision is then made to deploy a stent, a PTA should not be billed separately when a stent is already planned and the PTA is used to improve access for the stent deployment, says Gay Boughton-Barnes, CPC, MPC, CCS-P, senior medical compliance officer with the University of Oklahoma in Tulsa.

The carotid PTA/stent, by definition, is performed to deploy the stent; therefore, only 37205 (transcatheter placement of an intravascular stent[s], [non-coronary vessel], percutaneous; initial vessel) should be billed: 35475 (transluminal balloon angioplasty, percutaneous; brachiocephalic trunk or branches, each vessel) should not be billed.

HCFAs coverage decision memorandum does not address billing and reimbursement. A program memo that elaborates on payment is expected; however, carriers may differ in their interpretation of payment instructions, even if they are included in the memo. Further, some local carriers may determine the stent (and therefore, the entire service) is not covered.

Physicians with patients in clinical trials should contact their local Medicare carrier to determine if the PTA/stent is now covered and, if so, how the carrier wants the service billed.