LCD/NCD Portal
Automated World Health
L32107
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).
Coding Information
Bill Type Codes
• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.
• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.
• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.
12x Hospital Inpatient (Medicare Part B only)
13x Hospital Outpatient
85x Critical Access Hospital
Revenue Codes
• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.
• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.
• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.
0320 Radiology - Diagnostic - General Classification
0320 Radiology - Diagnostic - General Classification
0321 Radiology - Diagnostic - Angiocardiology
0322 Radiology - Diagnostic - Arthrography
0323 Radiology - Diagnostic - Arteriography
0323 Radiology - Diagnostic - Arteriography
0324 Radiology - Diagnostic - Chest X-Ray
0329 Radiology - Diagnostic - Other Radiology - Diagnostic
0329 Radiology - Diagnostic - Other Radiology - Diagnostic
0340 Nuclear Medicine - General Classification
0342 Nuclear Medicine - Therapeutic
0349 Nuclear Medicine - Other Nuclear Medicine
0350 CT Scan - General Classification
0351 CT Scan - CT - Head Scan
0352 CT Scan - CT - Body Scan
0359 CT Scan - CT Other
0402 Other Imaging Services - Ultrasound
0404 Other Imaging Services - Positron Emission Tomography
0409 Other Imaging Services - Other Imaging Services
0610 Magnetic Resonance Technology (MRT) - General Classification
0614 Magnetic Resonance Technology (MRT) - MRI - Other
0615 Magnetic Resonance Technology (MRT) - MRA - Head and Neck
0616 Magnetic Resonance Technology (MRT) - MRA - Lower Extremities
0618 Magnetic Resonance Technology (MRT) - MRA - Other
0619 Magnetic Resonance Technology (MRT) - Other MRT
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