SUPERSEDED Local Coverage Determination (LCD)

Vascular Stenting of Lower Extremity Arteries

L33763

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.
Superseded
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Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33763
Original ICD-9 LCD ID
Not Applicable
LCD Title
Vascular Stenting of Lower Extremity Arteries
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 10/01/2019
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

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.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2023, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Vascular Stenting of Lower Extremity Arteries. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Vascular Stenting of Lower Extremity Arteries and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

Internet Only Manual (IOM) Citations:

  • CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,
    • Chapter 1, Part 1, Section 20.7 Percutaneous Transluminal Angioplasty (PTA) (Various Effective Dates Below)
  • CMS IOM Publication 100-08, Medicare Program Integrity Manual,
    • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

  • Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. 
  • Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations. 
  • Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Covered Indications

Vascular stenting of lower extremity arteries performed for clinically significant occlusive vascular disease will be considered 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

Vascular stenting of lower extremity arteries is considered 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).

Any procedure has benefit and risk that the treating physician discusses with the patient. To meet the reasonable and necessary 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).

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description
N/A

Revenue Codes

Code Description
N/A

CPT/HCPCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

N/A

Group 1 Codes:

N/A

N/A

Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

Please refer to the Local Coverage Article: Billing and Coding: Vascular Stenting of Lower Extremity Arteries (A57180) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.

Utilization Guidelines

Please refer to the Local Coverage Article: Billing and Coding: Vascular Stenting of Lower Extremity Arteries (A57180) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Sources of Information

FCSO reference LCD number(s) – L32102

ACR Appropriateness Criteria® Claudication – Suspected Vascular Etiology. (2009).

ACR Appropriateness Criteria® Iliac Artery Occlusive Disease. (2009).

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.

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.

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.

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.

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.

Bibliography

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Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
10/01/2019 R3

Revision Number: 2
Publication: September 2019 Connection
LCR A/B2019-058

Explanation of Revision: Based on Change Request (CR) 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes”, “Revenue Codes”, “CPT/HCPCS Codes”, “ICD-10 Codes that Support Medical Necessity”, “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. During the process of moving the ICD-10-CM diagnosis codes to the billing and coding article, the ICD-10-CM diagnosis code ranges were broken out and listed individually. In addition, the Social Security Act and IOM reference sections were updated. The effective date of this revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018.

Based on CR 11322/CR 11333 (Annual 2020 ICD-10-CM Update) the newly created Billing and Coding Article was revised. Descriptor revised for ICD-10-CM diagnosis codes I70.238 and I70.248. The effective date of this revision is for dates of service on or after 10/01/19.

10/01/2019: At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination and therefore not all the fields included on the LCD are applicable as noted in this LCD.

  • Revisions Due To ICD-10-CM Code Changes
  • Other (Revisions based on CRs 10901, 11322, 11333)
10/01/2015 R2

Revision 1

The LCD was revised to remove Revenue Codes 0320, 0323, and 0329 as they are included in Revenue Code 032X. Also, resolved a technical error for a link in the "Sources of Information" section of the LCD for a listed source.

  • Other
10/01/2015 R1 The language and/or ICD-10-CM diagnoses were updated to be consistent with the current ICD-9-CM LCD’s language and coding.
  • Provider Education/Guidance
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Associated Documents

Attachments
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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
05/05/2023 10/01/2019 - 05/01/2023 Retired View
10/02/2019 10/01/2019 - N/A Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

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