Stenting for Renal Artery Stenosis and CMS Reimbursement: An Interview with Matthew Edwards, MD and Steven Textor, MD

One of the challenges facing medicine today is how to best allocate resources. As medical costs continue to rise, agencies such as the Centers for Medicare & Medicaid Services (CMS) must ensure that money is spent in a responsible manner. This requirement has resulted in the development of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). MEDCAC was established to provide “independent guidance and expert advice” to the CMS on various topics. MEDCAC evaluates strength of evidence and makes recommendations to the CMS based upon the evidence. One area of interest for the CMS has been the management of renal artery stenosis (RAS) as it relates to revascularization via stenting. Vascular Disease Management is pleased to interview Matthew Edwards and Stephen Textor on the topic of renal artery stenting and reimbursement. Both Dr. Edwards and Dr. Textor participated in the (MEDCAC) meeting regarding stenting for RAS in 2007. Matthew Edwards, MD, is Associate Professor of Vascular and Endovascular Surgery at Wake Forest University Baptist Medical Center in Winston-Salem, North Carolina. He is actively involved in RAS research and performs both percutaneous and open surgical revascularization procedures for RAS. Stephen Textor, MD, is Professor of Medicine in Nephrology and Hypertension at the Mayo Clinic in Rochester, Minnesota. He has been a leading researcher in the area of renovascular hypertension for many years.

What impact should clinical trials in general have on CMS decisions regarding payment for renal stenting?

Edwards: The clinical trials should have a strong impact on these reimbursement decisions. When MEDCAC looked at this issue the panel actually voted to limit reimbursement based upon the available evidence. Textor: The results of the trials need to be considered; excess weight should not be placed upon these results. Often, a negative trial says more about the study design than about the therapy. It would be a mistake to deny patients a potentially beneficial therapy due to the failure of a flawed trial to show benefit.

Given the results of the recently published STAR and ASTRAL trials, should CMS continue to pay for renal stenting outside of a clinical trial?

Textor: As Matt noted, in 2007 the MEDCAC panel voted to limit reimbursement, but to date, RAS stenting has not been limited. There should be efforts made to enroll patients into clinical trials and registries. At The Mayo Clinic I would estimate that during the time CORAL was enrolling patients, ten-fold more were treated than enrolled in CORAL, so we need to do a better job at getting patients into trials and registries. However, there still needs to be some mechanism to allow patients who may benefit from revascularization for RAS to receive the therapy. Edwards: No, reimbursement should be limited to patients in clinical trials such as CORAL. Additionally, for patients not enrolled in randomized clinical trials, large CMS-approved registries need to be established to allow for reimbursement, but with the caveat that extensive prospective data collection take place, allowing for critical analysis of efficacy and outcomes for ongoing practice patterns. It is unacceptable that we are unable to get the answers regarding revascularization for RAS when 50,000 procedures are being performed annually.

When the results of CORAL are available, would a negative trial mean the end of reimbursement for renal artery stenting?

Textor: Not necessarily. Often, the investigators have clear ideas about who should be considered for enrollment in a trial and who should receive the therapy being studied. This is what contributed to such a large discrepancy between patients receiving renal artery stents, versus those enrolled in CORAL. Edwards: I support limiting reimbursement to patients enrolled in studies so that the questions can be answered. Clearly, some patients benefit from these procedures, but we are not able to readily identify who they are. If CORAL is negative, then reimbursement should be limited to other studies or the aforementioned registries. If CORAL were to demonstrate widespread benefit, then reimbursement for stenting would certainly be reasonable. Although STAR and ASTRAL were negative, within the past year Philip Kalra and colleagues published prospective cohort data suggesting a benefit of stenting among patients with RAS and chronic kidney disease (CKD). To what degree should such studies impact CMS decisions regarding reimbursement? Edwards: There are similar data in the surgical literature suggesting that patients with more advanced renal dysfunction may be more likely to derive benefit from revascularization. These types of data should be used to help define the population of patients to be studied in future trials. Textor: It is interesting to look at these data. Some of the patients included in the U.K. cohort in this study had been enrolled in ASTRAL, which included a statement that to be eligible for enrollment a patient’s physician had to be uncertain that revascularization was beneficial. This again speaks to the fact that a negative trial says more about the study than the treatment. Given the current state of evidence, there should be uncertainty about the benefit for all patients.

What role should guidelines published by the ACC/AHA/ SCAI/SVS, etc. have in the CMS decisions?

Edwards: I am not a big fan of these guidelines. Guidelines and experts’ statements are not a substitute for data. Given the prevalence of RAS and the number of procedures performed each year, there is no reason why high-quality data should not be available to replace expert opinion. Textor: I am distinctly ambivalent on this issue. In the absence of high-quality trial data, the statements can be overreaching. Additionally, the members of these societies have a stake in this, so despite best efforts and intentions, some degree of objectivity may be lost.

If renal stenting were a new procedure like carotid stenting, would it face the same reimbursement challenges?

Textor: Historically, surgical revascularization for RAS has been an established treatment with benefit for some patients; however, compared to the days when surgery was the only option, medical therapy has improved. Furthermore, due to decreased procedural morbidity, endovascular stenting has expanded the number of candidates for revascularization. This creates confusion. If renal artery stenting were just now starting, it is likely that more data would be needed before allowing for widespread reimbursement of these procedures. Edwards: The CMS approach to carotid stenting is appropriate and a similar approach to renal artery revascularization would also be appropriate. Under these conditions, more patients would be placed into studies and then the questions regarding revascularization for RAS would finally be answered.

Should surgical revascularization of RAS be covered?

Textor: Reimbursement for surgical revascularization should be covered in some cases. Edwards: Reimbursement for surgical management of RAS should be subject to the same rules as stenting. There needs to be clear evidence of benefit, otherwise it should be restricted to patients involved in an approved study or registry. There is a clear role for surgical revascularization in patients with factors such as significant disease involving the aorta. In my practice, among patients with atherosclerotic renal artery stenosis, approximately 20% are treated with open procedures.

Should coverage for renal stenting be limited to certain clinical scenarios and if so, which ones? Who would decide if a patient meets the criteria?

Textor: One approach would be to have a local committee, similar to tumor boards that meet to discuss patients with cancer. Such a committee would be multidisciplinary and would help to make sure patients have been thoroughly evaluated before undergoing a procedure. Also, these committees could help try to direct patients into clinical trials, just as tumor boards help direct oncology patients into clinical trials. Edwards: A committee approach would be best; however, it is possible that such a committee could wind up causing gridlock if adequate agreement could not be reached regarding a patient who may benefit from revascularization.

Everyone involved in renal stenting can identify several patients who have demonstrated a clear benefit. Even within randomized trials, some patients clearly benefit from the procedure, yet within large randomized, controlled trials, there is not a generalized benefit. In an era where the CMS needs to control costs and provide maximum value for healthcare dollars, how is it possible to reconcile the discrepancy between the individual and the group?

Edwards: This is a tough question and if anyone has a good answer, he or she should be in Washington, D.C. The fact that some patients benefit from revascularization speaks to the need to get more patients in studies so the target population for benefit can be identified. Textor: I think that to some degree, physicians are less likely to stent as soon as a stenosis is found. More patients are being placed on good medical therapy for RAS, and stenting is being deferred until there is evidence of failure of such therapy. This approach may help to strike such a balance, but currently it is dependent upon physicians making reasonable decisions.

In the future it may be that reimbursement will no longer be linked to specific procedures, but rather will be shifted to an outcomes-based approach. In this model a given healthcare system may receive a lump payment for a particular patient with a given condition. How that money is spent would then be up to the hospitals/physicians to decide. What impact might such a change have on renal artery stenting? Given the controversy surrounding renal stenting, would allowing decisions regarding its use to be made by multiple local decision-makers be hazardous to patient outcomes?

Edwards: This type of approach would greatly limit the use of revascularization for RAS. Due to many challenges, I think the implementation of such a system is unlikely. Many patients receive their care in multiple locations. This creates logistical challenges, such as to how assign the reimbursement. Textor: The goal of this system would be to utilize resources by removing the incentive for simply performing a procedure. The consequence could be to create an incentive to not perform procedures, thus potentially denying some patients benefit. Thanks to both of you for taking the time to share your thoughts on this subject.

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VASCULAR DISEASE MANAGEMENT 2011;8:3E38–E39