DRAFT

Latest Review Date:   February 2025            

Category:  Surgical   

POLICY:

Effective for dates of service on and after April 15, 2025:

Percutaneous endovascular revascularization procedures (e.g. angioplasty, stents, and /or atherectomy) for lower extremity peripheral arterial disease in adults ≥18 years of age is considered medically necessary for the following indications:

• Acute limb ischemia (present for <2 weeks duration) in a marginally or immediately viable limb or threatened limb.
• Chronic limb-threatening ischemia (CLTI) when the following criteria are met:
  • One or more of the following:
    • Ischemic rest pain
    • Nonhealing wound/ulcers (present for at least 2 weeks)
    • Gangrene

AND

• Documentation of occlusive arterial disease as evidenced by abi index ≤ 0.90 (i.e., resting or exercise), monophasic waveform by ultrasound, or stenosis of greater than 50%)

• Claudication when ALL of the following are met:
  • The individual has life-limiting disability caused by claudication such that they cannot perform occupational tasks or activities of daily living
  • Documentation of occlusive arterial disease as evidenced by abi index ≤ 0.90 (i.e., resting or exercise),
  • Documentation of confirmed anatomical location of significant occlusive disease (stenosis of greater than 50%), or monophasic waveform by ultrasound
  • Individual is a non-smoker and has not smoked for at least three months prior to procedure
  • Individual has tried and failed at least 6 months of conservative therapy, consisting of both supervised exercise therapy and pharmacologic therapy.

Percutaneous endovascular revascularization procedures (e.g., stents, angioplasty, and/or atherectomy) for treating lower extremity ischemia are considered investigational in the following circumstances due to insufficient evidence of efficacy:

• Interventions performed for non-limb-threatening infrapopliteal (e.g., anterior tibial, posterior tibial, or peroneal) artery disease
• Individual is asymptomatic
• To prevent the progression of claudication to CLTI
• Transluminal peripheral atherectomy of the iliac artery
• Treatment of a nonviable limb

Endovenous femoropopliteal bypass using a stent graft is considered investigational for treating peripheral artery disease.

Peripheral bioresorbable stents are considered investigational.

Effective for dates of service prior to April 15, 2025:

Endovenous femoropopliteal bypass using a stent graft is considered investigational for treating peripheral artery disease.

Peripheral bioresorbable stents are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Peripheral arterial disease (PAD) is the narrowing or blockage of blood flow in vessels leading to the lower extremities.  The primary cause for PAD is a build-up of plaque in the arteries, known as atherosclerosis.  This can lead to significant leg pain or claudication, ulcerations, ischemia, and possibly limb loss. The ankle-brachial index (ABI) can be used to confirm PAD.  It provides a measure of the severity of disease and may be indicative of coronary heart disease.  An ABI of <0.90 has a high degree of sensitivity and specificity for PAD, and likely indicates arterial stenosis of ≥50%.   

PAD is associated with multiple risk factors such as smoking, diabetes, hypertension, and a sedentary lifestyle. Intermittent claudication is a classic symptom of PAD.  Early identification, risk factor modification, antiplatelet medication and exercise are vital to improve the outcome of individuals with PAD.  When these treatments fail or if the individual has severe disease, surgical or endovascular treatment may be needed.

Either surgical or percutaneous revascularization are treatment options for certain individuals with lower extremity peripheral arterial disease. Percutaneous revascularization procedures include balloon angioplasty, stent procedures, and atherectomy.

KEY POINTS:

The most recent literature search was performed through February 13, 2025.

Summary of Evidence

For individuals with acute limb ischemia or those with chronic limb-threatening ischemia, the evidence includes randomized controlled trials, systematic reviews, prospective studies, retrospective studies and observational studies. Relevant outcomes are functional outcomes, symptoms, and treatment-related mortality and morbidity. For acute limb ischemia, a meta-analysis showed that endovascular and surgical approaches have similar rates of short-term and 12-month mortality, limb amputation and recurrent ischemia. For chronic limb-threatening ischemia, studies have shown for appropriately selected patients that safety and technical success is high, and morbidity and mortality rates are lower compared to open surgery.  Additionally, other studies have demonstrated high 12-month rates of limb salvage.  The evidence is sufficient to determine that the treatment results in a meaningful improvement in the net health outcome.

For individuals with claudication, the evidence includes systematic reviews, randomized trials, and single arm trials.  Relevant outcomes are functional outcomes, symptoms, and treatment-related morbidity. Studies have shown that revascularization should usually be offered only if medical management fails to improve symptoms. Smoking is associated with a significant increase in PAD-related hospitalizations and revascularization procedures. The 5-year mortality rate with active smoking and chronic symptomatic PAD is 40%-50%. Additionally, 80%-90% of patients revascularized for severe limb symptoms are current smokers.  If claudication is not responsive to lifestyle changes or medication, then surgical or endovascular treatment is recommended.  The evidence is sufficient to determine that the treatment results in a meaningful improvement in the net health outcome.

For individuals with non-limb threatening ischemia, asymptomatic PAD, or treatment to prevent the progression of claudication to CLTI , the evidence includes systematic reviews, prospective reviews, and retrospective reviews. Relevant outcomes are functional outcomes, symptoms, and treatment-related morbidity. Evidence has shown that lifestyle modifications like smoking cessation, exercise, and medication should be the first approach for this population of individuals. Some individuals with asymptomatic PAD may progress to symptomatic disease. However, there is no data to support that early revascularization procedures will inhibit progression to symptomatic PAD. Lifestyle changes and medication are the primary treatment approach. The evidence is insufficient to determine that the treatment results in a meaningful improvement in the net health outcome.

For individuals receiving transluminal peripheral atherectomy of the iliac artery, the evidence includes a retrospective study and a case series.  Relevant outcomes include functional outcomes, symptoms, and treatment-related morbidity. The available studies only assessed safety and feasibility or small with no long-term results. The evidence is insufficient to determine that the treatment results in a meaningful improvement in the net health outcome. 

For individuals with a confirmed nonviable limb, there is no evidence supporting endovascular procedures over an amputation. The evidence is insufficient to determine that the treatment results in a meaningful improvement in the net health outcome.

For individuals receiving an endovenous femoropopliteal bypass procedure, the evidence includes a single-arm, non-randomized, prospective study.  Relevant outcomes are safety, effectiveness, and treatment-related mortality and morbidity. The DETOUR system is a novel device that is currently in clinical trials.  It uses a stent routed through the femoral vein to restore blood flow to the leg. Long term, larger, high-quality studies evaluating the safety and efficacy of the procedure comparing the DETOUR system with open surgical bypass are needed. The evidence is insufficient to determine that the treatment results in a meaningful improvement in the net health outcome.

For individuals receiving a peripheral bioresorbable stent, the evidence includes prospective studies, observational studies, and a systematic review. Experience with the use of bioresorbable stents in PAD is still limited and has been investigated only in small studies. One study with a 5- year outcome stated that the 12-month patency rate did not meet the prespecified protocol.  At 5 years, only 2 patients had been discontinued from anticoagulation therapy.  Well-designed, long-term studies comparing bioresorbable stents to metal stents are needed. The evidence is insufficient to determine that the treatment results in a meaningful improvement in the net health outcome.

Practice Guidelines and Position Statements

American College of Cardiology (ACC), American Heart Association (AHA), American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR), et al

In 2024, a guideline for the management of lower extremity PAD was published by a joint committee of 11 societies.  Below are their recommendations:

COR-Class of Recommendation, LOE-Level of Evidence, Class 1- strong, benefit >>> risk, Class 2a-moderate, benefit >> risk, Class 2b-weak, benefit >/= risk, Class 3 – No Benefit (moderate), benefit = risk, Class 3- harm (strong), risk > benefit, COR indicates COR; EO- expert opinion, LD – limited data, NR- nonrandomized, R – randomized

U.S. Preventative Services Task Force Recommendations

No recommendation

KEY WORDS:

Peripheral artery disease, PAD, endovascular, atherosclerosis, DETOUR, ESPRIT, Remedy, peripheral stent, lower extremity, lower extremity stent

APPROVED BY GOVERNING BODIES:

The FDA has approved several stent, stent systems, and catheter systems for the treatment of endovenous PAD.

In June 2020, the DETOUR system (Endologix) received FDA designation as a Breakthrough Device. On June 7, 2023, the FDA granted full premarket approval of the DETOUR System.

In April 2024, the Esprit BTK Everolimus Eluting Resorbable Scaffold System was approved as a breakthrough innovation.

BENEFIT APLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING: 

CPT Codes:

REFERENCES:

1. Abbott. Press release for the Esprit resorbable scaffold.  Available at: https://abbott.mediaroom.com/2024-04-29-Abbotts-Breakthrough-Dissolving-Stent-Receives-FDA-Approval-for-Arteries-Below-the-Knee.
2. Abouzid MR, Vyas A, Kamel I, et al. Comparing the efficacy and safety of endovascular therapy versus surgical revascularization for critical limb-threatening ischemia: A systematic review and Meta-analysis. Prog Cardiovasc Dis. Jul 07 2024.
3. American Association of Cardiovascular and Pulmonary Rehabilitation, American Podiatric Medical Association, Association of Black Cardiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine, Society for Vascular Nursing, Society for Vascular Surgery, Society of Interventional Radiology, and Vascular & Endovascular Surgery Society. 2024 ACC/AHA/AACVPR/APMA/ ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease. Circulation. 2024 Jun 11;149(24):e1313-e1410. doi: 10.1161/CIR.0000000000001251.
4. Bradbury AW, Moakes CA, Popplewell M, et al. A vein bypass first versus a best endovascular treatment first revascularisation strategy for patients with chronic limb threatening ischaemia who required an infra-popliteal, with or without an additional more proximal infrainguinal revascularisation procedure to restore limb perfusion (BASIL-2): an open-label, randomised, multicentre, phase 3 trial. Lancet. May 27 2023; 401(10390): 1798-1809.
5. Centers for Disease Control. Heart Disease. About Peripheral Arterial Disease (PAD). Available at: www.cdc.gov/heart-disease/about/peripheral-arterial-disease.html.
6. Dattilo R, Himmelstein SI, Cuff RF. The COMPLIANCE 360° Trial: a randomized, prospective, multicenter, pilot study comparing acute and long-term results of orbital atherectomy to balloon angioplasty for calcified femoropopliteal disease. J Invasive Cardiol. Aug 2014; 26(8): 355-60.
7. Firnhaber JM, Powell CS. Lower extremity peripheral artery disease: Diagnosis and treatment. Am Fam Physician. 2019;99(6):362-369.
8. Galyfos G, Liakopoulos D, Chamzin A, et al. A systematic review and meta-analysis of early and late outcomes after endovascular angioplasty among patients with thromboangitis obliterans and chronic limb ischemia. J Vasc Surg. 2023 May;77(5):1534-1541.
9. Gul F, Janzer SF.  Peripheral Vascular Disease. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan. 2023 Jun 6.
10. Hirsch AT, Treat-Jacobson D, Lando HA, et al. The role of tobacco cessation, antiplatelet and lipid-lowering therapies in the treatment of peripheral arterial disease. Vasc Med. 1997; 2:243–251.
11. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
12. Kinlay S. Management of critical limb ischemia. Circ Cardiovasc Interv. 2016 Feb;9(2):e001946.
13. Lammer J, Bosiers M, Deloose K, et al. Bioresorbable everolimus-eluting vascular scaffold for patients with peripheral artery disease (ESPIT I): 2-year clinical and imaging results.  JACC Cadiovasc Interv. 2016 Jun132;9(11):1178-87.
14. Lee MS, Martinsen BJ, Hollowed J, et al. Acute procedural outcomes of orbital atherectomy for the treatment of iliac artery disease: sub-analysis of the CONFIRM registries. Cardiovasc Revasc Med. 2018 Jul;19(5 Pt A):503-505.
15. Neschis DG, Golden MA.  Lower extremity peripheral artery disease: clinical features and diagnosis.  Up To Date.  Available at: https://www.uptodate.com/contents/lower-extremity-peripheral-artery-disease-clinical-features-and-diagnosis?search=peripheral%20artery%20disease%20%20&source=search_result&selectedTitle=1%7E150&usage_type=default&display_rank=1#H497999997.
16. Obara H, Matsubara K, Fujimura N, et al. Five-Year outcomes of the bioresorbable peripheral remedy stent in the treatment of iliac artery disease. J Vasc Interv Radiol. 2023 Jun;34(6):1024-1035.
17. Olinic DM, Stanek A, Tataru DA, et al.  Acute limb ischemia; An update on diagnosis and management.  J Clin Med. 2019 Aug14;8(8):1215.
18. Perlander A, Jivegard L, Nordanstig, et al. Amputation-free survival, limb symptom alleviation, and reintervention rates after open and endovascular revascularization of femoropopliteal lesions in patients with chronic limb-threatening ischemia.  J Vasc Surg. 2020 Dec;72(6):1987-1995.
19. Rao S, Martinsen BJ, Higgins J, et al.  Orbital atherectomy for treating calcified iliac artery disease to enable large bore device delivery: A case series report. SAGE Open Med Case Rep. 2020 Jul 22:8:2050313X20943068.
20. Siracuse JJ, Farber A, Menard MT, et al.  Perioperative complications following open or endovascular revascularization for chronic limb-threatening ischemia in the BEST-CLI Trial.  J Vasc Surg. 2023 Oct;78(4):1012-1020.
21. Van Haelst ST, Peeters Weem SM, Moll FL, deBorst GJ.  Current status and future perspectives of bioresorbable stents in peripheral arterial disease. J Vasc Surg. 2016 Oct;64(4):1151-1159.
22. Veenstra EB, van der Laan MJ, Zeebregts CJ, et al. A systematic review and meta-analysis of endovascular and surgical revascularization techniques in acute limb ischemia. J Vasc Surg. Feb 2020; 71(2): 654-668.
23. Wardle BG, Ambler GK, Radwan RW, et al. Atherectomy for peripheral arterial disease. Cochrane Database Syst Rev. Sep 29 2020; 9(9): CD006680.

POLICY HISTORY:

Medical Policy Group, March 2025 (4): Created new policy for endovascular procedures for peripheral artery disease.  Bioresorbable stents and endovenous femoropopliteal bypass previously included on investigational listings.

Medical Policy Administration Committee, February 2025Available for comment March 1, 2025 through April 15, 2025

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and    
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.