CAS Reimbursement: Anatomy of a Retraction

On April 30, 2007, the Centers for Medicare and Medicaid Services (CMS) Coverage and Analysis Group (CAG) posted their Final Decision for 2007 regarding Medicare coverage for carotid stenting (CAS). In brief, they decided to:

• retract their proposed expansion of coverage to include asymptomatic high-risk surgical patients (HR);

• retract the proposed coverage exclusion of octogenarians;

• retract the proposed requirement for a surgical consultation to determine high-risk status for CEA;

• refine the requirements for facility recertification for CAS;

• reaffirm their previous decision to cover CAS only when using embolic protection.

In other words, CMS completely retracted their recent proposal to change and expand CAS coverage (CAG-00085R3) and essentially left things alone. No doubt, some physician groups (cardiologists, in particular) and industry will feel disappointed as they expected exactly the opposite outcome and one that, in the minds of many, was a “done deal.” Why were they so “wrong”, and why would CMS issue such a “game-changing” proposal only to retract it all in the end? I offer the following possible rationale:

• Let us consider first the asymptomatic HR surgical patients. While a great deal of data have been generated through multiple registries and a few large post-market surveillance (PMS) studies, the level of existing scientific information is just insufficient to support expanding the reach of CAS to asymptomatic patients, almost regardless of risk status. But perhaps the most persuasive argument is that the expansion of payment coverage to include these patients might seriously impair the ability to complete the all-important randomized trials that might, one day soon, provide the kind of evidence that will determine just where CAS belongs in our armamentarium to treat carotid artery disease. The agency received a large amount of input in this regard, much of it offering strong opposition to the proposal, and apparently agreed with the view that the timely completion of such trials would have been seriously compromised, as investigators may lose interest in enrolling patients with the availability of much wider reimbursement coverage outside clinical research.

• The decision to continue coverage for CAS when performed on patients over the age of 80 likely reflected the lack of consensus on the matter. In truth, it seems a bit precipitous and “radical” to exclude octogenarians from CAS altogether. The evidence against it is rather limited and, at best, influenced strongly by learning-curve and case-selection issues.

• Maintaining the current policy of non-payment when an embolic protection (EP) device cannot be used is difficult to rationalize or even justify. It would be appropriate and perfectly reasonable to allow this in well-documented instances where the operator has attempted delivery and deployment of an EP device, or when in his/her opinion, the risk of using EP exceeds its potential benefits on patients presenting with a compelling indication for intervention and where CAS is the only reasonable option

• Lastly, mandating a surgical consultation to determine HR status for CEA makes a lot of sense to me, and it would receive strong backing from the vascular surgery community.

However, I can also see that it would carry significant potential for political friction and ethical dilemmas in many hospitals across the country. CAS represents, undoubtedly, a very important new tool for treatment of severe carotid artery stenosis. It has gained its rightful place in the management of HR patients where it may well replace CEA as the standard of care in the near future — particularly for those patients presenting with anatomic (not physiologic) HR factors. However, when compared with CEA, carotid stenting has not yet been proven an equal to surgery when applied to non-HR patients. Surgical treatment will continue to be the intervention of choice for most of these in the foreseeable future. Having said that, I would not “discount” CAS just yet! Its core components and technologies (access and EP) will continue to improve — perhaps dramatically — while CEA is not likely to evolve much further from its current status. And the day may come indeed when carotid stenting evolves to a fully competitive status with CEA.

Until then, the current regulatory and reimbursement environment in the United States dictates and limits utilization rather severely. And those institutions and investigators involved in clinical research may continue to enjoy the ability to do stenting for many more patients but within the context of well-controlled Category B trials or PMS studies. For the rest, and beyond approvals and reimbursement, the direction seems clear: CAS technologies are here to stay, but they should be applied wisely and for the right reasons. More importantly yet, it is incumbent upon us all to learn to identify, with clarity, situations where carotid stenting should not be performed because it may not be in the patient’s best interest.