Percutaneous Renal Revascularization and Medicare Coverage
The Society of Interventional Radiology's position on the current CMS coverage of renal interventions.
The Centers for Medicare & Medicaid Services (CMS) has recently solicited input to revise the National Coverage Decision (NCD) for treating atherosclerotic renal artery stenosis (RAS) with percutaneous revascularization (balloon angioplasty and/or stenting, [PTA/S]). Through an NCD, CMS provides a list of appropriate indications for treatment. This list is then used to determine if CMS will reimburse for a procedure. It is possible that some physicians may not realize that CMS limits reimbursement according to approved indication. Certainly, this is the case for carotid stenting, for which CMS currently will reimburse only if the procedure is performed on a symptomatic patient at high surgical risk with at least an 80% diameter stenosis. All other patients insured by CMS are not covered for reimbursement unless they are part of an approved trial. It was recently announced that the carotid stent NCD will not be expanded.
PRESENT CMS POLICY
As of April 2007, renal artery interventions are covered under the NCD for percutaneous transluminal angioplasty (Medicare NCD Manual, 20.7). The indications in that policy for renal interventions are limited to "patients in whom there is an inadequate response to a thorough medical management of symptoms and for whom surgery is the likely alternative. The PTA for this group of patients is an alternative to surgery, not simply an addition to medical management."
Medicare coverage of renal artery stenting is at the discretion of local Medicare contractors. To our knowledge, only one carrier—Blue Cross and Blue Shield of Arkansas—has a detailed Local Carrier Decisions specifically for renal artery angioplasty and stent placement (LCD L8678). Because most regions are covered by the generic NCD, the standard for reimbursement seems to have been covered by Title XVIII of the Social Security Act, section 1862(a)(1)(A), which allows coverage and payment only for services that are considered "medically reasonable and necessary."
Most commonly, the range of indications for reimbursement would include severe hypertension refractory to multiple medications, renal salvage in an azotemic patient, and "prophylaxis" in a currently asymptomatic patient with normal renal function. The Society of Interventional Radiology (SIR) is not aware of the benchmark of consideration for surgery having been used as a litmus test for reimbursement; in fact, such a prerequisite would be difficult to implement without individual filing of paper claims and chart reviews. Such a standard is also difficult to rationalize. Because surgery is known to be more invasive than angioplasty or stent placement, it is not reasonable to consider them as alternatives; the risk-benefit analysis that routinely determines medical decision making would favor angioplasty or stent placement for many more patients than the inherently risky alternative—surgery.1 The use of renal PTA/S has grown tremendously in a short period of time.2 Among interventional radiologists, the annual growth in use of renal PTA/S was 10% between 1996 and 2000.2 Among interventional cardiologists over the same time period, annual growth was 31%.2
Unfortunately, it is unclear if the growth in percutaneous renal interventions represents overuse or appropriate use of medical care. Surgical revascularization of RAS is associated with a tenfold greater risk of 30-day mortality compared with stent placement3 and a much higher risk of systemic complications, such as myocardial infarction, heart failure, respiratory failure, and kidney failure.1 But the lower risk from renal PTA/S does not guarantee clinical benefit, and patients can be harmed from the revascularization by contrast nephrotoxicity, arterial injury, or cholesterol embolizaton. There have been several randomized trials, which have evaluated the outcomes from renal PTA/S, with variable results. These trials have been criticized.4 Many of the recommendations for renal revascularization in a recent multispecialty guideline5 are based heavily on expert consensus rather than trial evidence. The Agency for Health Care Research and Quality commissioned a review (effectivehealthcare.ahrq.gov/synthesize/reports/execSummary.cfm?Topic=42) that concluded that there is no good evidence to support renal artery interventional therapy for any indication. There is currently a large-scale randomized clinical trial designed to assess the value of renal artery stent placement for atherosclerotic obstruction and hypertension or chronic kidney disease funded primarily by the National Heart, Lung, and Blood Institute of the National Institutes of Health—the Cardiovascular Outcomes with Renal Atherosclerotic Lesions (CORAL) trial (www.coralclinicaltrial.org). Until the results of well-designed randomized clinical trials, such as the CORAL trial, are available, there will remain uncertainty as to who needs and benefits from renal PTA/S. It is in this context that CMS has opened the NCD for renal revascularization. The comments in the sidebar indicate the opinion of SIR on this issue and have been submitted to CMS for review.
Some readers may be surprised that SIR is not advocating unrestricted reimbursement for renal PTA/S. The mission of SIR is improving public health through disease management and minimally invasive, image-guided therapeutic interventions. We take this mission seriously. We do not improve public health by providing medical care that does not make people better. In the situation where we do not know, we support and help create trials to determine what is the best care. We do not always have Class 1 evidence (large, randomized, controlled trials) to rely upon, in which case we make our recommendations as listed based on the best available evidence, weighing the risk of immediate harm from intervention versus the potential benefit from revascularization. At the same time, we are creating trials to produce Class 1 evidence.
One of the authors of this article, Dr. Tim Murphy, is a principal investigator in the CORAL trial, which is a multicenter, NIH-funded trial of renal stents plus best medical therapy versus medical therapy alone to treat hypertension due to RAS. Eligibility requirements are listed in Table 1. Study endpoints are listed in Table 2. At this time, 183 patients have been randomized, with a goal of enrolling a total of 1,080 patients. The expected date of completion of the study is 2011. However, changes in reimbursement that make it easier or harder to be reimbursed for renal PTA/S for routine clinical care may affect the ability to enroll patients.
The future of medicine will be more data driven both for clinical care and reimbursement. The revision of the renal NCD by CMS is part of a process that is likely to be repeated for many high-volume and high-growth procedures that lack Class 1 evidence for all indications. We believe that interventionists are better off being part of the process, offering our expertise in a credible and constructive way, and helping to create and perform the research that will provide the necessary evidence to justify the effectiveness and cost effectiveness of our care.
David Sacks, MD, is President of the Society of Interventional Radiology. He is with Advanced Interventional Radiology at the Reading Hospital and Medical Center in West Reading, Pennsylvania. He has disclosed that he holds no financial interest in any product or manufacturer mentioned herein. Dr. Sacks may be reached at (610) 988-8927; firstname.lastname@example.org.
Timothy P. Murphy, MD, is on the Executive Council of the Society of Interventional Radiology, and is the Medical Director of the Vascular Disease Research Center at Rhode Island Hospital and Professor of Diagnostic Imaging at the Warren Alpert Medical School at Brown University, in Providence, Rhode Island. He is also a national coprincipal investigator in the CORAL Study. He has disclosed that he holds no financial interest in any product or manufacturer mentioned herein. Dr. Murphy may be reached at email@example.com.