Status: Revised Effective Date: 06/18/2023
Doc ID: CAR07-0623.2 Last Review Date: 01/24/2023
Approval and implementation dates for specific health plans may vary. Please consult the applicable health plan for more details.
Clinical Appropriateness Guidelines
Appropriate Use Criteria: Endovascular Revascularization for Management of Arterial Disease of the Lower Extremities
© 2023 Carelon Medical Benefits Management, Inc. All rights reserved.
Table of Contents
Description and Application of the Guidelines
Endovascular Revascularization for Management of Arterial Disease of the Lower Extremities
Description and Application of the Guidelines
The Carelon Clinical Appropriateness Guidelines (hereinafter “the Carelon Clinical Appropriateness Guidelines” or the “Guidelines”) are designed to assist providers in making the most appropriate treatment decision for a specific clinical condition for an individual. As used by Carelon, the Guidelines establish objective and evidence-based criteria for medical necessity determinations where possible. In the process, multiple functions are accomplished:
- To establish criteria for when services are medically necessary (i.e., in general, shown to be effective in improving health outcomes and considered the most appropriate level of service)
- To assist the practitioner as an educational tool
- To encourage standardization of medical practice patterns
- To curtail the performance of inappropriate and/or duplicate services
- To advocate for patient safety concerns
- To enhance the quality of health care
- To promote the most efficient and cost-effective use of services
The Carelon guideline development process complies with applicable accreditation standards, including the requirement that the Guidelines be developed with involvement from appropriate providers with current clinical expertise relevant to the Guidelines under review and be based on the most up-to-date clinical principles and best practices. Relevant citations are included in the References section attached to each Guideline. Carelon reviews all of its Guidelines at least annually.
Carelon makes its Guidelines publicly available on its website twenty-four hours a day, seven days a week. Copies of the Carelon Clinical Appropriateness Guidelines are also available upon oral or written request. Although the Guidelines are publicly-available, Carelon considers the Guidelines to be important, proprietary information of Carelon, which cannot be sold, assigned, leased, licensed, reproduced or distributed without the written consent of Carelon.
Carelon applies objective and evidence-based criteria, and takes individual circumstances and the local delivery system into account when determining the medical appropriateness of health care services. The Carelon Guidelines are just guidelines for the provision of specialty health services. These criteria are designed to guide both providers and reviewers to the most appropriate services based on a patient’s unique circumstances. In all cases, clinical judgment consistent with the standards of good medical practice should be used when applying the Guidelines. Guideline determinations are made based on the information provided at the time of the request. It is expected that medical necessity decisions may change as new information is provided or based on unique aspects of the patient’s condition. The treating clinician has final authority and responsibility for treatment decisions regarding the care of the patient and for justifying and demonstrating the existence of medical necessity for the requested service. The Guidelines are not a substitute for the experience and judgment of a physician or other health care professionals. Any clinician seeking to apply or consult the Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment.
The Guidelines do not address coverage, benefit or other plan specific issues. Applicable federal and state coverage mandates take precedence over these clinical guidelines. If requested by a health plan, Carelon will review requests based on health plan medical policy/guidelines in lieu of the Carelon Guidelines. Pharmaceuticals, radiotracers, or medical devices used in any of the diagnostic or therapeutic interventions listed in the Guidelines must be FDA approved or conditionally approved for the intended use. However, use of an FDA approved or conditionally approved product does not constitute medical necessity or guarantee reimbursement by the respective health plan.
The Guidelines may also be used by the health plan or by Carelon for purposes of provider education, or to review the medical necessity of services by any provider who has been notified of the need for medical necessity review, due to billing practices or claims that are not consistent with other providers in terms of frequency or some other manner.
General Clinical Guideline
Clinical Appropriateness Framework
Critical to any finding of clinical appropriateness under the guidelines for a specific diagnostic or therapeutic intervention are the following elements:
- Prior to any intervention, it is essential that the clinician confirm the diagnosis or establish its pretest likelihood based on a complete evaluation of the patient. This includes a history and physical examination and, where applicable, a review of relevant laboratory studies, diagnostic testing, and response to prior therapeutic intervention.
- The anticipated benefit of the recommended intervention should outweigh any potential harms that may result (net benefit).
- Current literature and/or standards of medical practice should support that the recommended intervention offers the greatest net benefit among competing alternatives.
- Based on the clinical evaluation, current literature, and standards of medical practice, there exists a reasonable likelihood that the intervention will change management and/or lead to an improved outcome for the patient.
If these elements are not established with respect to a given request, the determination of appropriateness will most likely require a peer-to-peer conversation to understand the individual and unique facts that would supersede the requirements set forth above. During the peer-to-peer conversation, factors such as patient acuity and setting of service may also be taken into account.
Simultaneous Ordering of Multiple Diagnostic or Therapeutic Interventions
Requests for multiple diagnostic or therapeutic interventions at the same time will often require a peer-to-peer conversation to understand the individual circumstances that support the medical necessity of performing all interventions simultaneously. This is based on the fact that appropriateness of additional intervention is often dependent on the outcome of the initial intervention.
Additionally, either of the following may apply:
- Current literature and/or standards of medical practice support that one of the requested diagnostic or therapeutic interventions is more appropriate in the clinical situation presented; or
- One of the diagnostic or therapeutic interventions requested is more likely to improve patient outcomes based on current literature and/or standards of medical practice.
Repeat Diagnostic Intervention
In general, repeated testing of the same anatomic location for the same indication should be limited to evaluation following an intervention, or when there is a change in clinical status such that additional testing is required to determine next steps in management. At times, it may be necessary to repeat a test using different techniques or protocols to clarify a finding or result of the original study.
Repeated testing for the same indication using the same or similar technology may be subject to additional review or require peer-to-peer conversation in the following scenarios:
- Repeated diagnostic testing at the same facility due to technical issues
- Repeated diagnostic testing requested at a different facility due to provider preference or quality concerns
- Repeated diagnostic testing of the same anatomic area based on persistent symptoms with no clinical change, treatment, or intervention since the previous study
- Repeated diagnostic testing of the same anatomic area by different providers for the same member over a short period of time
Repeat Therapeutic Intervention
In general, repeated therapeutic intervention in the same anatomic area is considered appropriate when the prior intervention proved effective or beneficial and the expected duration of relief has lapsed. A repeat intervention requested prior to the expected duration of relief is not appropriate unless it can be confirmed that the prior intervention was never administered.
Endovascular Revascularization for Management of Arterial Disease of the Lower Extremities
The following code list is not meant to be all-inclusive. Authorization requirements will vary by health plan. Please consult the applicable health plan for guidance on specific procedure codes.
Specific CPT codes for services should be used when available. Nonspecific or not otherwise classified codes may be subject to additional documentation requirements and review.
CPT® (Current Procedural Terminology) is a registered trademark of the American Medical Association (AMA). CPT® five-digit codes, nomenclature and other data are copyright by the American Medical Association. All Rights Reserved. AMA does not directly or indirectly practice medicine or dispense medical services. AMA assumes no liability for the data contained herein or not contained herein.
Endovenous femoral-popliteal arterial revascularization, with transcatheter placement of intravascular stent graft(s) and closure by any method, including percutaneous or open vascular access, ultrasound guidance for vascular access when performed, all catheterization(s) and intraprocedural road mapping and imaging guidance necessary to complete the intervention, all associated radiological supervision and interpretation, when performed, with crossing of the occlusive lesion in an extraluminal fashion
Revascularization, endovascular, open or percutaneous, iliac artery, unilateral, initial vessel; with transluminal angioplasty
Revascularization, endovascular, open or percutaneous, iliac artery, unilateral, initial vessel; with transluminal stent placement(s), includes angioplasty within the same vessel, when performed
Revascularization, endovascular, open or percutaneous, iliac artery, each additional ipsilateral iliac vessel; with transluminal angioplasty
Revascularization, endovascular, open or percutaneous, iliac artery, each additional ipsilateral iliac vessel; with transluminal stent placement(s), includes angioplasty within the same vessel, when performed
Revascularization, endovascular, open or percutaneous, femoral, popliteal artery(s), unilateral; with transluminal angioplasty
Revascularization, endovascular, open or percutaneous, femoral, popliteal artery(s), unilateral; with atherectomy, includes angioplasty within the same vessel, when performed
Revascularization, endovascular, open or percutaneous, femoral, popliteal artery(s), unilateral; with transluminal stent placement(s), includes angioplasty within the same vessel, when performed
Revascularization, endovascular, open or percutaneous, femoral, popliteal artery(s), unilateral; with transluminal stent placement(s) and atherectomy, includes angioplasty within the same vessel, when performed
Revascularization, endovascular, open or percutaneous, tibial, peroneal artery, unilateral, initial vessel; with transluminal angioplasty
Revascularization, endovascular, open or percutaneous, tibial, peroneal artery, unilateral, initial vessel; with atherectomy, includes angioplasty within the same vessel, when performed
Revascularization, endovascular, open or percutaneous, tibial, peroneal artery, unilateral, initial vessel; with transluminal stent placement(s), includes angioplasty within the same vessel, when performed
Revascularization, endovascular, open or percutaneous, tibial, peroneal artery, unilateral, initial vessel; with transluminal stent placement(s) and atherectomy, includes angioplasty within the same vessel, when performed
Revascularization, endovascular, open or percutaneous, tibial/peroneal artery, unilateral, each additional vessel; with transluminal angioplasty
Revascularization, endovascular, open or percutaneous, tibial/peroneal artery, unilateral, each additional vessel; with atherectomy, includes angioplasty within the same vessel, when performed (List separately in addition to code for primary procedure)
Revascularization, endovascular, open or percutaneous, tibial/peroneal artery, unilateral, each additional vessel; with transluminal stent placement(s), includes angioplasty within the same vessel, when performed (List separately in addition to code for primary procedure)
Revascularization, endovascular, open or percutaneous, tibial/peroneal artery, unilateral, each additional vessel; with transluminal stent placement(s) and atherectomy, includes angioplasty within the same vessel, when performed
Endovascular procedures for the management of peripheral arterial disease of the lower extremities include standalone balloon angioplasty, stent placement, or atherectomy. The vessel may be accessed through a small incision (open) or a vascular sheath (percutaneous). The management of patients with peripheral arterial disease of the lower extremities is dictated largely by the patient’s symptom status. In general, patients can be classified as follows: asymptomatic, those with claudication, and those with critical limb ischemia. Endovascular procedures may be used in primary (lesion has not previously been treated) or secondary (lesion has previously been treated) management of peripheral arterial disease.
Asymptomatic patients and those with atypical symptoms: Risk factor modification (healthy diet, smoking cessation, management of hypertension, hyperlipidemia and diabetes) is the cornerstone of management of asymptomatic patients who are at risk for, or are known to have, peripheral arterial disease.
Patients with claudication: Risk factor modification (healthy diet, smoking cessation, management of hypertension, hyperlipidemia and diabetes) should be undertaken in all patients with claudication. In addition, patients with claudication should participate in a supervised (preferably) or home-based structured exercise program. Pharmacologic agents such as cilostazol and antiplatelet agents should be used per current recommendations. Revascularization (whether surgical or endovascular) should be reserved for patients who despite an adequate trial of conservative therapy have persistent claudication which significantly limits lifestyle.
Critical limb ischemia as evidenced by ischemic rest pain, ischemic skin ulceration, gangrene, etc., requires urgent management with the optimal approach determined on a case-by-case basis. Patients with critical limb ischemia are at increased risk of both limb loss and cardiovascular death.
This guideline addresses the appropriateness of endovascular revascularization procedures (open or percutaneous) in patients with peripheral arterial disease of the lower extremities including disease of the aortoiliac, femoral, popliteal, tibial, and peroneal arteries. Acute arterial occlusion is a medical emergency managed in the emergency room or inpatient setting and is not addressed in this guideline.
Optimal medical therapy for patients with peripheral arterial disease includes all of the following, unless contraindicated:
- Aspirin or clopidogrel
- High-intensity statin
- ACE inhibitor or angiotensin receptor blocker
- Treatment of diabetes and hypertension, if present
- Tobacco cessation which includes a trial of at least TWO (2) of the following agents:
- Nicotine supplements
Structured exercise programs, which may be directly supervised or home based, are designed to have the patient “walk through” his/her claudication and increase exercise tolerance and walking distance over time. Exercise sessions lasting at least 30 minutes should be performed 3 times a week for an initial period of 12 weeks.
Secondary stenting describes stent deployment when results of balloon angioplasty are suboptimal. Suboptimal results include residual diameter stenosis greater than 50%, persistent translesional pressure gradient, or flow-limiting dissection.
No history of revascularization
Standalone balloon angioplasty, primary stenting, or secondary stenting is considered medically necessary in EITHER of the following scenarios:
- Critical limb ischemia
- Claudication and ALL of the following:
- Significant lifestyle impairment or vocational limitation due to claudication
- Lack of improvement following at least three (3) months of conservative therapy* that includes BOTH of the following:
- A structured exercise program (supervised or home based)
- Optimal medical therapy as defined above
- Absence of another condition limiting exercise capacity (e.g., cardiac, pulmonary, or musculoskeletal disease) such that revascularization is expected to result in significant functional improvement
- The target lesion is located in the aortoiliac or above-knee femoropopliteal vessels
*Note: When improvement is evident at 3 months, an additional 3 months of conservative therapy should be undertaken before a decision is made regarding revascularization.
History of revascularization
Standalone balloon angioplasty, primary stenting, or secondary stenting is considered medically necessary in ANY of the following scenarios:
- Symptomatic patients with restenosis at the site of previous endovascular revascularization
- Symptomatic patients with focal stenosis in a venous or prosthetic bypass graft
- Asymptomatic patients with hemodynamically significant stenosis in a venous bypass graft
Treatment of peripheral arterial disease prior to a vascular access procedure
Standalone balloon angioplasty, primary stenting, or secondary stenting is considered medically necessary in patients with a known stenotic lesion in order to facilitate vascular access for percutaneous coronary intervention, large vascular intervention (e.g., endovascular repair of abdominal aortic aneurysm), or percutaneous valvular replacement/repair.
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- Abramson BL, Al-Omran M, Anand SS, et al. Canadian Cardiovascular Society 2022 Guidelines for Peripheral Arterial Disease. The Canadian journal of cardiology. 2022;38(5):560-87.
- Bailey SR, Beckman JA, Dao TD, et al. ACC/AHA/SCAI/SIR/SVM 2018 Appropriate Use Criteria for Peripheral Artery Intervention: A Report of the American College of Cardiology Appropriate Use Criteria Task Force, American Heart Association, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, and Society for Vascular Medicine. Journal of the American College of Cardiology. 2019;73(2):214-37.
- Barua RS, Rigotti NA, Benowitz NL, Cummings KM, et al. 2018 ACC expert consensus decision pathway on tobacco cessation treatment. J Am Coll Cardiol 2018;72:3332–65.
- Conte MS, Bradbury AW, Kolh P, et al. Global vascular guidelines on the management of chronic limb-threatening ischemia. Journal of vascular surgery. 2019;69(6s):3S-125S.e40
- Conte MS, Pomposelli FB, Clair DG, et al. Society for Vascular Surgery practice guidelines for atherosclerotic occlusive disease of the lower extremities: management of asymptomatic disease and claudication. Journal of vascular surgery. 2015;61(3 Suppl):2s-41s.
- Creasy TS, McMillan PJ, Fletcher EW, et al. Is percutaneous transluminal angioplasty better than exercise for claudication? Preliminary results from a prospective randomised trial. European journal of vascular surgery. 1990;4(2):135-40.
- Criqui MH, Matsushita K, Aboyans V, et al. Lower Extremity Peripheral Artery Disease: Contemporary Epidemiology, Management Gaps, and Future Directions: A Scientific Statement From the American Heart Association. Circulation. 2021;144(9):e171-e91.
- Djerf H, Millinger J, Falkenberg M, et al. Absence of Long-Term Benefit of Revascularization in Patients With Intermittent Claudication: Five-Year Results From the IRONIC Randomized Controlled Trial. Circ. 2020;13(1):e008450.
- Fakhry F, Rouwet EV, den Hoed PT, et al. Long-term clinical effectiveness of supervised exercise therapy versus endovascular revascularization for intermittent claudication from a randomized clinical trial. The British journal of surgery. 2013;100(9):1164-71.
- Fakhry F, Spronk S, van der Laan L, et al. Endovascular Revascularization and Supervised Exercise for Peripheral Artery Disease and Intermittent Claudication: A Randomized Clinical Trial. Jama. 2015;314(18):1936-44.
- Farkas K, Kolossvary E, Jarai Z. Simple assessment of quality of life and lower limb functional capacity during cilostazol treatment – results of the SHort-tERm cIlostazol eFFicacy and quality of life (SHERIFF) study. Vasa. 2020;49(3):235-42.
- Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: Executive Summary. Vasc Med. 2017;22(3):Np1-np43.
- Hischke S, Ries HC, Bublitz MK, et al. Quality Indicators in Peripheral Arterial Occlusive Disease Treatment: A Systematic Review. Eur J Vasc Endovasc Surg. 2019;58(5):738-45.
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- Lane R, Harwood A, Watson L, et al. Exercise for intermittent claudication. The Cochrane database of systematic reviews. 2017;12:Cd000990.
- Mazari FA, Gulati S, Rahman MN, et al. Early outcomes from a randomized, controlled trial of supervised exercise, angioplasty, and combined therapy in intermittent claudication. Ann Vasc Surg. 2010;24(1):69-79.
- Mazari FA, Khan JA, Carradice D, et al. Randomized clinical trial of percutaneous transluminal angioplasty, supervised exercise and combined treatment for intermittent claudication due to femoropopliteal arterial disease. The British journal of surgery. 2012;99(1):39-48.
- Murphy TP, Cutlip DE, Regensteiner JG, et al. Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the claudication: exercise versus endoluminal revascularization (CLEVER) study. Circulation. 2012;125(1):130-9.
- Murphy TP, Cutlip DE, Regensteiner JG, et al. Supervised exercise, stent revascularization, or medical therapy for claudication due to aortoiliac peripheral artery disease: the CLEVER study. Journal of the American College of Cardiology. 2015;65(10):999-1009.
- Rooke TW, Hirsch AT, Misra S, et al. Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA Guideline Recommendations): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology. 2013;61(14):1555-70.
- Saratzis A, Paraskevopoulos I, Patel S, et al. Supervised Exercise Therapy and Revascularization for Intermittent Claudication: Network Meta-Analysis of Randomized Controlled Trials. JACC Cardiovasc Interv. 2019;12(12):1125-36.
- Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. The New England journal of medicine. 2006;354(18):1879-88.
- Treat-Jacobson D, McDermott MM, Bronas UG, et al. Optimal Exercise Programs for Patients With Peripheral Artery Disease: A Scientific Statement From the American Heart Association. Circulation. 2019;139(4):e10-e33.
Independent Multispecialty Physician Panel (IMPP) review. Removed use of cilostazol as a required component of conservative therapy and optimal medical therapy. Added clarification for symptomatic patients with restenosis at the site of previous endovascular revascularization.
IMPP review. Restructured for clarity. Added references. Guideline reaffirmed. Original effective date.
IMPP review. Updated references. Guideline reaffirmed.
Literature Review. Added reference.