Coverage Policy Manual
Policy #: 2000015
Category: Surgery
Initiated: December 1999
Last Review: July 2023
  Renal Artery, Angioplasty/Stenting, Percutaneous
Description: Renal artery stenosis may be due to atherosclerosis, intimal hyperplasia or arteritis of the renal artery, and may result in renal artery hypertension, progressive renal failure, or to "flash" or recurrent pulmonary edema.  Renal artery stenosis is also a recognized problem for patients who have had kidney transplants. Previous treatment has been restricted to open surgical repair of the stenosis.  Percutaneous transluminal angioplasty, with or without stenting, is now a common approach to  revascularization of the renal artery(s).  Revascularization should be based on clinical symptoms in those patients with hemodynamically significant stenoses.  

Several stents have been FDA-approved for use in renal arteries.

CPT 35471 is the billing code for percutaneous transluminal angioplasty of the renal or visceral artery.  There is no specific code for stenting of a renal artery, but CPT 37205 is transcatheter placement of an intravascular stent(s), (non-coronary vessel), percutaneous, initial; and CPT 37206 is for placement of a stent in each additional vessel.
Policy/
Coverage:
Effective July 2021
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Renal artery angioplasty or stenting meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for:
 
        • patients with rapidly progressive renal insufficiency due to atherosclerotic stenosis of greater than or equal to 75% obstruction; or  
        • patients with recurrent acute pulmonary edema without cardiac cause, who have stenosis of the renal artery(s) of greater than or equal to 60%; or  
        • patients with renal artery stenosis of greater than or equal to 50% in a transplanted kidney; or
        • patients with hypertension related to fibromuscular dysplasia with renal artery stenosis > 60%
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Any other use of renal artery angioplasty or stenting does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, any other use of renal artery angioplasty or stenting is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to July 2021
Renal artery angioplasty or stenting meets member benefit certificate primary coverage criteria for effectiveness and is covered for :
    • patients with rapidly progressive renal insufficiency due to atherosclerotic stenosis of greater than or equal to 75% obstruction; or  
    • patients with recurrent acute pulmonary edema without cardiac cause, who have stenosis of the renal artery(s) of greater than or equal to 60%; or  
    • patients with renal artery stenosis of greater than or equal to 50% in a transplanted kidney; or
    • patients with hypertension related to fibromuscular dysplasia with renal artery stenosis > 60%.
                             
Any other use of renal artery angioplasty or stenting does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, any other use of renal artery angioplasty or stenting is considered investigational and is not covered. Investigational services are exclusions in the member benefit certificate of coverage.
 
Effective, August 2005 to November 2009
Renal artery angioplasty meets primary coverage criteria for effectiveness and is covered for patients with uncontrolled hypertension (diastolic blood pressure greater than 100 mm Hg on two antihypertensive drugs) and who have been found to have unilateral or bilateral renal artery stenosis of  50% or greater by nuclear medicine studies, renal artery duplex Doppler, or renal arteriography, or magnetic resonance angiography.  
 
Renal artery angioplasty meets primary coverage criteria for effectiveness and is covered for patients with rapidly progressive renal insufficiency due to atherosclerotic stenosis of greater than or equal to 75% obstruction.  
 
Renal artery angioplasty meets primary coverage criteria for effectiveness and is covered for patients with recurrent acute pulmonary edema without cardiac cause, who have stenosis of the renal artery(s) of greater than or equal to 60%.  
 
Renal artery angioplasty meets primary coverage criteria for effectiveness and is covered for patients with renal artery stenosis of greater than or equal to 50% in a transplanted kidney.  
 
Renal artery stents meet primary coverage criteria for effectiveness and are covered for:
    • Stenosis of the ostium of a renal artery that has a normal diameter of 5 mm or greater
    • Restenosis of a lesion successfully treated with balloon angioplasty in the past
    • Failure to attain satisfactory result from balloon angioplasty as determined by:
      • greater than 30% stenosis of the luminal diameter after balloon angioplasty
      • failure to eliminate a hemodynamically significant pressure gradient
      • presence of a flow-limiting dissection of the renal artery
 
Any other use of renal artery angioplasty or stenting does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
 
For contracts without Primary Coverage Criteria, Any other use of renal artery angioplasty or stenting is considered investigational and is not covered. Investigational services are an exclusion in the member benefit certificate.
 
 
Effective, December 1999-July 2005
Renal artery angioplasty is covered for patients with uncontrolled hypertension (diastolic blood pressure > 100 mm Hg on two antihypertensive drugs) who have been found to have unilateral or bilateral renal artery stenosis of 50% or greater by nuclear medicine studies, renal artery duplex Doppler, or renal arteriography, or magnetic resonance angiography. Stenting meets coverage criteria for ostial lesions, for angioplasty with sub-optimal results, and for dissection.  For patients with renal artery stenosis of < 50%, and suspected renovascular hypertension, coverage criteria are met if renal vein renin studies indicate the hypertension is due to renal artery disease.
 
Renal artery angioplasty is covered for patients with rapidly progressive renal insufficiency due to atherosclerotic stenosis of =/> 75% obstruction.  Stenting  meets coverage criteria for ostial lesions, for angioplasty with sub-optimal results, and for dissection.  
 
Renal artery angioplasty is covered for patients with recurrent acute pulmonary edema without cardiac cause, who have stenosis of the renal artery(s) of =/> 60%.  Stenting meets coverage criteria for ostial lesions, for angioplasty with suboptimal results, and for dissection.
 
Renal artery angioplasty is covered for patients with renal artery stenosis of =/> 50% in a transplanted kidney.  Stenting meets coverage criteria for ostial lesions, for angioplasty with suboptimal results, and for dissection.
 
Renal artery angioplasty with or without stenting is not covered for patients with renal artery atherosclerosis or stenosis but who do not have any of the conditions mentioned above.
  
 
Rationale:
Which patient should be studied with renal arteriography, and which anatomical lesions should be treated are active questions in the medical community.  At the 1999 American Society of Nephrology meeting, Dr. Stephen Textor, a nephrologist in the division of hypertension at the Mayo Clinic stated:  "We don't know the natural history of truly incidental renal artery stenosis.  A Pandora's box is opened when cardiologists routinely check the renal arteries of a patient undergoing coronary artery catheterization.  While the information is important, this practice may lead many to fix anatomic lesions that don't need fixing…In one recent survey, about 30% of patients who underwent coronary catheterization also had renal artery stenosis, and in half of these patients the stenosis blocked more than 50% of the vessel…Even if renal artery disease is present and treatable by angioplasty, the key issue is whether treatment helps the patient.  A lot of lesions don't progress rapidly, and the rate of progression can be reduced by smoking cessation and the use of statins."  
 
The effectiveness of percutaneous renal artery angioplasty with or without stenting for patients with uncontrolled hypertension has been studied in a multicenter randomized controlled trial and was shown to have little advantage over antihypertensive drug therapy.  Present data suggests a higher benefit in patients with fibromuscular hyperplasia than in patients with atherosclerotic disease.
 
Data on the effectiveness of percutaneous renal artery angioplasty with or without stenting for patients with rapidly progressive renal failure is less available.
 
Data on the effectiveness of percutaneous renal artery angioplasty with or without stenting for patients with atherosclerotic narrowing of the renal artery but without renal insufficiency or uncontrolled hypertension is not reported in peer reviewed medical literature.
 
Data on the effectiveness of percutaneous renal artery angioplasty with or without stenting for patients with "flash" pulmonary edema or recurrent pulmonary edema of unknown cause comes from observational studies with limited patients who received varying therapy.  It does appear to be an increasingly recognized entity in patients without known cardiac disease, and has been described following renal artery stenosis associated with renal transplantation.
 
In the face of ongoing controversy about the appropriate role of intervention for RAS, the dramatic increase in stenting procedures (primarily by cardiologists) has led CMS to initiate a review its payment coverage for atherosclerotic RAS (Textor, 2008).  A major concern is that the degree of severity of vascular occlusion in atherosclerosis bears little relationship to measured blood flow, kidney volume, degree of fibrosis, or glomerular filtration rate (Garovic, 2005),  and it is almost certain that many patients now undergoing endovascular stenting of the renal arteries have only limited benefit (Levin, 2007).  On the other hand, it is important to recognize that some patients with “critical” RAS do stand to have major clinical benefit from opening the renal arteries (Textor, 2006).  A literature review (Balk, 2007) of MEDLINE through September 2005 found no robust studies to support either medical or interventional therapy as superior treatment for atherosclerotic RAS. The ACC/AHA guidelines (Hirsch, 2006) continue to offer reasonable guidance in patient selection for renal artery intervention.
 
2009 Update
Bax and colleagues published results of a 140 patient randomized controlled trial to assess the efficacy and safety of stent placement in patients with atherosclerotic renal artery stenosis (Bax et al, 2009). The study revealed that stent placement showed no benefit in patients with renal impairment.  In addition, there were two procedure related deaths in the stent group.
 
The ASTRAL trial (ASTRAL Investigators, 2009) conducted a randomized trial in patients with atherosclerotic renovascular disease, comparing medical therapy alone vs. medical therapy plus renal artery angioplasty with or without stenting.  The primary outcome was renal function, and secondary outcomes were blood pressure, time to major cardiovascular events, and mortality.  Median follow-up was 34 months, maximum follow-up was 5 years.  95% of the patients randomized to renal artery angioplasty received a stent.  Approximately 60% of patients in each group. had renal artery stenosis >70%.  9% of revascularization patients had a complication with 24 hours of the procedure; 20% had an adverse outcome between 24 hours and 1 month of the procedure.  No evidence of a worthwhile clinical benefit in the initial years after revascularization was found in these patients.  Blood pressure decreased during follow-up in both groups.  There was no significant difference in the change in renal function between the groups over time.  It was concluded that “Since endovascular interventions are associated with substantial morbidity, inconvenience, and cost, with little apparent benefit, the widespread use of such procedures outside of clinical trials can now be questioned.  A related implication is that there seems to be little value in screening asymptomatic patients who have atherosclerosis and chronic renal disease or hypertension for evidence of renovascular disease.  The authors noted that a limitation of their study is that patients were enrolled in the trial only if their own physician was uncertain as to whether revascularization would provide a worthwhile clinical benefit.  Additionally, it is noted that there is an unproven consensus that certain groups  with severe renal-artery stenosis (such as those with acute kidney injury or “flash” pulmonary edema should be treated with revascularization, but that such patients were unlikely to have been included in this trial.  Finally, it was noted hat the rate of progression of renal impairment in the medical-therapy group was lower than anticipated based on historical data.  This may relate to excellent medical management of these patients.  Based on this study, renal artery angioplasty/stenting does not meet primary coverage criteria for effectiveness for patients with renovascular hypertension except in very specific circumstances.
 
2012 Update
A literature search conducted through September 2012 did not identify any new information that would prompt a change in the coverage statement.
 
Two systematic reviews were identified (Kumbhani, 2011; Steichen, 2010) which indicate percutaneous revascularization does not improve health outcomes over medical management as a primary treatment for renal artery stenosis.
 
A systematic review of randomized controlled trials was conducted to assess the benefit of percutaneous revascularization versus medical management of patients with renal artery stenosis (Kumbhani, 2011).  Six trials with over 1000 patients were reviewed.  The authors concluded, although there is an associated decreased requirement for antihypertensive medications with percutaneous revascularization compared to medical management alone; there is not an accompanying decrease in serum creatinine and clinical outcomes.  “Further studies are needed to identify the appropriate patient population…to benefit from its use” (Kumbhani, 2011).
 
Steichen and colleagues reviewed the controlled studies on primary stenting for the treatment of renal artery stenosis (Steichen, 2010). The authors concluded that medical management should be the preferred treatment of asymptomatic, stable patients without a compelling indication for revascularization.
 
Two ongoing randomized controlled trials were identified on the clinicaltrials.gov website comparing revascularization to medical management of patients with renal artery stenosis NCT00640406 and NCT00081731.
 
2013 Update
A literature search was conducted using the MEDLINE database through September 2013. There was no new information identified that would prompt a change in the coverage statement.
  
2014 Update
 
A literature search conducted through June 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
 
A RTC was identified by Cooper and colleagues on stenting and medical therapy for atherosclerotic renal-artery stenosis (Cooper, 2014). 947 randomly assigned participants who had atherosclerotic renal-artery stenosis and either systolic hypertension while taking two or more antihypertensive drugs or chronic kidney disease to medical therapy plus renal-artery stenting or medical therapy alone. Participants were followed for the occurrence of adverse cardiovascular and renal events (a composite end point of death from cardiovascular or renal causes, myocardial infarction, stroke, hospitalization for congestive heart failure, progressive renal insufficiency, or the need for renal-replacement therapy).  Over a median follow-up period of 43 months (interquartile range, 31 to 55), the rate of the primary composite end point did not differ significantly between participants who underwent stenting in addition to receiving medical therapy and those who received medical therapy alone (35.1% and 35.8%, respectively; hazard ratio with stenting, 0.94; 95% confidence interval [CI], 0.76 to 1.17; P=0.58). There were also no significant differences between the treatment groups in the rates of the individual components of the primary end point or in all-cause mortality. During follow-up, there was a consistent modest difference in systolic blood pressure favoring the stent group (-2.3 mm Hg; 95% CI, -4.4 to -0.2; P=0.03). Renal-artery stenting did not confer a significant benefit with respect to the prevention of clinical events when added to comprehensive, multifactorial medical therapy in people with atherosclerotic renal-artery stenosis and hypertension or chronic kidney disease. (Funded by the National Heart, Lung and Blood Institute and others; ClinicalTrials.gov number, NCT00081731.).
   
2016 Update
A literature search conducted through June 2016 did not reveal any new information that would prompt a change in the coverage statement.
 
2017 Update
A literature search conducted through June 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
ONGOING AND UNPUBLISHED CLINICAL TRIALS
A search of ClinicalTrials.gov in May 2017 did not identify any ongoing or unpublished trials that would likely influence this review. A previously mentioned clinical trial has completed and has no published results.
 
(NCT00640406) Comparison of Best Medical Treatment Versus Best Medical Treatment Plus Renal Artery Stenting (RADAR), completed July 2015 with no results posted.
 
2018 Update
A literature search was conducted through June 2018.  There was no new information identified that would prompt a change in the coverage statement.  
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
A literature search was conducted through June 2020.  There was no new information identified that would prompt a change in the coverage statement.  
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2021. No new literature was identified that would prompt a change in the coverage statement.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2023. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
37236Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; initial artery
37237Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; each additional artery (List separately in addition to code for primary procedure)
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ASTRAL Investigators.(2009) Revascularization versus medical therapy for renal-artery stenosis. NEJM 209;361:1853-1962.

Balk E, Raman G, et al.(2006) Effectiveness of management strategies for renal artery stenosis: a systematic review. Ann Intern Med, 2006; 145:901.

Bax L, Willem P, et al.(2002) Repeated intervention for in-stent restenosis of the renal arteries. J Vasc Interv Radiol 2002; 13:1219-24.

Bax L, Woittiez AJ, Kouwenberg HJ et al.(2009) Stent placement in patients with atherosclerotic renal artery stenosis and impaired renal function. Ann Intern Med. 2009;150:840-848.

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Buller CE, Nogareda JG, et al.(2004) The profile of cardiac patients with renal artery stenosis. J Am Coll Cardiol 2004; 43:1606-13.

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Mackrell PJ, Langan EM 3rd, et al.(2003) Management of renal artery stenosis: effects of a shift from surgical to percutaneous therapy on indications and outcomes. Ann Vasc Surg 2003; 17:54-9.

Martin LG, Rundback JH, et al.(2003) Quality improvement guidelines for angiography, angioplasty, and stent placement in the diagnosis and treatment of renal artery stenosis in adults. J Vasc Interv Radiol 2003; 14:S297-310.

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Shammas NW, Kapalis MJ.(2004) Clinical and angiographic predictors of restenosis following renal artery stenting. J Invasive Cardiol 2004; 16:10-3.

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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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