LCD/NCD Portal

L32102

 

VASCULAR STENTING OF LOWER EXTREMITY ARTERIES

 

 

10/16/2011

 

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Medicare administrative contractor (MAC) jurisdiction 9 (J9) will consider vascular stenting of lower extremity arteries performed for clinically significant occlusive vascular disease medically reasonable and necessary for a patient under any of the following circumstances:

 

• Primary therapy for common iliac artery stenosis and occlusions.

• Primary therapy for external iliac artery stenoses and occlusions.

• Primary therapy for femoral/popliteal arterial stenosis and occlusions.

• Salvage therapy for common and external iliac arteries for a suboptimal or failed result from balloon dilation.

o Persistent translesional gradient.

o Residual diameter stenosis greater than 50%.

o Flow-limiting dissection.

• Salvage therapy for femoral/popliteal arteries for a suboptimal or failed result from balloon dilation.

o Persistent translesional gradient.

o Residual diameter stenosis greater than 50%.

o Flow-limiting dissection.

• Salvage therapy for tibial/peroneal arterial lesions for a suboptimal result from balloon dilation.

 

 

Limitations

 

Medicare administrative contractor (MAC) jurisdiction 9 (J9) considers vascular stenting of lower extremity arteries experimental and investigational for a patient under any of the following circumstances as the effectiveness has not been well established and/or is not recommended, and therefore, will not be considered medically reasonable and necessary:

• Primary therapy for tibial/peroneal arterial stenosis and occlusions.

• It is the expectation that for the covered indications of this policy, the utilized stent will have Food and Drug Administration (FDA) approval for that indication.

o ‘Off-label use’ of drug-eluting stents and polytetrafluoroethylene (PTFE)-covered stents are non-covered (given the FDA approved use as well as off-label use of such devices is a subject of on-going clinical trials).

o For the covered indications, a stent approved by the FDA may be covered for off-label use for which efficacy has been supported in peer-reviewed medical literature, given that there are no FDA-contraindications or warnings which have been demonstrated in this regard and given that its use has been a long standing standard of care (this statement is limited to vascular stents for lower extremity arteries as applied to this LCD).

 

 

CPT/HCPCS Codes

 

37221 REVASCULARIZATION, ENDOVASCULAR, OPEN OR PERCUTANEOUS, ILIAC ARTERY, UNILATERAL, INITIAL VESSEL; WITH TRANSLUMINAL STENT PLACEMENT(S), INCLUDES ANGIOPLASTY WITHIN THE SAME VESSEL, WHEN PERFORMED

37223 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 (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

37226 REVASCULARIZATION, ENDOVASCULAR, OPEN OR PERCUTANEOUS, FEMORAL, POPLITEAL ARTERY(S), UNILATERAL; WITH TRANSLUMINAL STENT PLACEMENT(S), INCLUDES ANGIOPLASTY WITHIN THE SAME VESSEL, WHEN PERFORMED

37227 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

37230 REVASCULARIZATION, ENDOVASCULAR, OPEN OR PERCUTANEOUS, TIBIAL, PERONEAL ARTERY, UNILATERAL, INITIAL VESSEL; WITH TRANSLUMINAL STENT PLACEMENT(S), INCLUDES ANGIOPLASTY WITHIN THE SAME VESSEL, WHEN PERFORMED

37231 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

37234 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)

37235 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 (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

 

 

ICD-9 Codes that Support Medical Necessity

 

440.20 ATHEROSCLEROSIS OF NATIVE ARTERIES OF THE EXTREMITIES UNSPECIFIED

440.21 ATHEROSCLEROSIS OF NATIVE ARTERIES OF THE EXTREMITIES WITH INTERMITTENT CLAUDICATION

440.22 ATHEROSCLEROSIS OF NATIVE ARTERIES OF THE EXTREMITIES WITH REST PAIN

440.23 ATHEROSCLEROSIS OF NATIVE ARTERIES OF THE EXTREMITIES WITH ULCERATION

440.24 ATHEROSCLEROSIS OF NATIVE ARTERIES OF THE EXTREMITIES WITH GANGRENE

443.22 DISSECTION OF ILIAC ARTERY

443.9 PERIPHERAL VASCULAR DISEASE UNSPECIFIED

444.22 ARTERIAL EMBOLISM AND THROMBOSIS OF LOWER EXTREMITY

444.81 EMBOLISM AND THROMBOSIS OF ILIAC ARTERY

444.89 EMBOLISM AND THROMBOSIS OF OTHER ARTERY

447.1 STRICTURE OF ARTERY

997.2 PERIPHERAL VASCULAR COMPLICATIONS NOT ELSEWHERE CLASSIFIED

 

 

Documentation Requirements

• Medical record documentation maintained by the performing physician must clearly indicate medical necessity for this service and made available to Medicare upon request.

o This documentation should also include, but is not limited, to the following(as applicable to the patient’s episode of care):

• Relevant medical history (e.g., claudication, critical limb ischemia).

• Vascular physical examination (including measurement of the ankle-brachial index).

• Previous noninvasive diagnostic evaluation(s).

• Detailed summary of the angiography report.

• Detailed summary of the procedure/operative report.

• Any procedure has benefit and risk that the treating physician discusses with the patient.

o To meet Medicare’s R&N threshold for coverage of a procedure, the physician’s documentation for the case should clearly support both the diagnostic criteria for the indication (standard test results and/or clinical findings as applicable) and the medical need (the procedure does not exceed the medical need and is at least as beneficial as existing alternatives and the procedure is furnished with accepted standards of medical practice in a setting appropriate for the patient’s medical needs and condition).

Treatment Logic

N/A

 

 

Sources of Information and Basis for Decision

 

ACR Appropriateness Criteria® Claudication – Suspected Vascular Etiology. (2009). Retrieved from http://www.guideline.gov/content.aspx?id=15775&search=claudication

 

ACR Appropriateness Criteria® Iliac Artery Occlusive Disease. (2009). Retrieved from http://www.guideline.gov/content.aspx?id=15729&search=iliac

 

Balk, E., Cepeda, M., Ip, S., Trikalinos, T., & O’Donnell, T. (2008). Horizon scan of invasive interventions for lower extremity peripheral artery disease and systematic review of studies comparing stent placement to other interventions. Technology assessment report prepared by the Tufts Evidence-based Practice Center for the Agency for Healthcare Research and Quality (AHRQ). Project ID: ARTS0407. Contract No. HHSA-290-2007-10055-1-EPC3. Retrieved from http://www.cms.hhs.gov/determinationprocess/downloads/id63TA.pdf.

 

FCSO LCD 32102, Vascular Stenting of Lower Extremity Arteries, 11/21/2011. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Gray, B., Conte, M., Dake, M., Jaff, M., Kandarpa, K., Ramee, S., Rundback, J., & Waksman, R., American Heart Association Writing Group 7. (2008). Atherosclerotic peripheral vascular disease symposium II: Lower-extremity revascularization: State of the art. Circulation, 118(25):2864-2872. doi:10.1161/CIRCULATIONAHA.108.191177. Retrieved from http://circ.ahajournals.org/cgi/reprint/118/25/2864

 

Hirsch, A., Haskal, Z., Hertzer, N., Bakal, C., Creager, M., Halperin, J., Hiratzka, L., Murphy, W., Olin, J., Puschett, J., Rosenfield, K., Sacks, D., Stanley, J., Taylor Jr., L. White, C., White, J., & White, R. (2006). ACC/AHA Guidelines for the Management of Patients with Peripheral Arterial Disease (Lower Extremity, Renal, Mesenteric, and Abdominal Aortic): A Collaborative Report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine and Biology, and the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease). Journal of the American College of Cardiology, 47, e1-e192. doi:10.1016/j.jacc.2006.02.024. Retrieved from http://circ.ahajournals.org/cgi/reprint/113/11/e463.

 

Laird, J., Katzen, B., Scheinert, D., Lammer, J., Carpenter, J., Buchbinder, M., Dave, R., Ansel, G., Lansky, A., Cristea, E., Collins, T., Goldstein, J., Jaff, M. (2010). Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: Twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv, 3, 267-276. doi:10.1161/CIRCINTERVENTIONS.109.903468

 

Olin, J., Allie, D., Belkin, M., Bonow, R., Casey Jr., D., Creager, M., Gerber, T., Hirsch, A., Jaff, M., Kaufman, J., Lewis, C., Martin, E., Martin, L., Sheehan, P., Stewart, K., Treat-Jacobson, D., White, C., & Zheng, Z. (2010).ACCF/AHA/ACR/SCAI/SIR/SVM/SVN/SVS 2010 Performance Measures for Adults with Peripheral Artery Disease: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures, the American College of Radiology, the Society for Cardiac Angiography and Interventions, the Society for Interventional Radiology, the Society for Vascular Medicine, the Society for Vascular Nursing, and the Society for Vascular Surgery (Writing Committee to Develop Clinical Performance Measures for Peripheral Artery Disease). Circulation, 122, 2583-2618. doi:10.1161/CIR.0b013e3182031a3c. Retrieved from http://circ.ahajournals.org/cgi/reprint/122/24/2583?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=ACR+Guidelines+peripheral+arterial+disease&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT

 

Schillinger, M., Sabeti, S., Dick, P., Amighi, J., Mlekusch, W., Schlager, O., Loewe, C., Cejna, M., Lammer, J., & Minar, E. (2007). Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation, 115, 2745-2749. doi:10.1161/CIRCULATIONAHA.107.688341

 

Schillinger, M., Sabeti,, S., Loewe, C., Dick, P., Amighi, J., Mlekusch, W., Schlager, O., Cejna, M., Lammer, J., & Minar, E. (2006). Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med, 354,(18) 1879-1888.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

 

 CMS LCD VASCULAR STENTING OF LOWER EXTREMITY ARTERIES