L32102-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Vascular Stenting of Lower Extremity Arteries (L32102)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L32102

LCD Title Vascular Stenting of Lower Extremity Arteries

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

Contractor's Determination Number 37221

Original Determination Effective Date

For services performed on or after 10/16/2011

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Ending Date

Revision Effective Date

For services performed on or after 10/16/2011

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources: CMS Manual System, Pub 100-02, Medicare Benefit Policy Manual, Chapter 11, Section 20.1

CMS Manual System, Pub 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Sections 20.7

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 (e.g., persistent translesional gradient, residual diameter stenosis greater than 50%, or flow-limiting dissection).

• Salvage therapy for femoral/popliteal arteries for a suboptimal or failed result from balloon dilation (e.g., persistent translesional gradient, residual diameter stenosis greater than 50%, or flow-limiting dissection).

• Salvage therapy for tibial/peroneal arterial lesions for a suboptimal result from ballon 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. ‘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). 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.

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.

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

440.20-440.24opensinnewwindow ATHEROSCLEROSIS OF NATIVE ARTERIES OF THE EXTREMITIES UNSPECIFIED - 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

444.81-444.89opensinnewwindow EMBOLISM AND THROMBOSIS OF ILIAC ARTERY - EMBOLISM AND THROMBOSIS OF OTHER ARTERY

447.1 STRICTURE OF ARTERY

997.2 PERIPHERAL VASCULAR COMPLICATIONS NOT ELSEWHERE CLASSIFIED

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

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

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

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.

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.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies.

Florida Contractor Advisory Committee Meeting held on June 18, 2011.

Puerto Rico/U.S. Virgin Islands Contractor Advisory Committee Meeting held on June 23, 2011.

Start Date of Comment Period 06/03/2011

End Date of Comment Period 07/18/2011

Start Date of Notice Period 09/02/2011

Revision History Number Original

Revision History Explanation Revision Number: Original Start Date of Comment Period:06/03/2011

Start Date of Notice Period:09/02/2011 Effective Date 10/16/2011

LCR B2011-094

September 2011 Connection

11/21/2011 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

37221 descriptor was changed in Group 1 37226 descriptor was changed in Group 1 37227 descriptor was changed in Group 1 37230 descriptor was changed in Group 1 37231 descriptor was changed in Group 1 37234 descriptor was changed in Group 1 37235 descriptor was changed in Group 1

Reason for Change