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Local Coverage Determination (LCD)

Treatment of Varicose Veins of the Lower Extremities

L34536

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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.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L34536
Original ICD-9 LCD ID
Not Applicable
LCD Title
Treatment of Varicose Veins of the Lower Extremities
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 08/31/2023
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A

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Issue

Issue Description

Biannual review completed with no change in coverage.
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act §1862(a)(1)(a). This section excludes coverage and payment for items and services that are not considered reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the function of a malformed body member.

Title XVIII of the Social Security Act §1862(a)(10). Cosmetic surgery is excluded from coverage.

Title XVIII of the Social Security Act §1862(a)(7). This section excludes routine physical examinations and services.

Title XVIII of the Social Security Act §1833(e). This section prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Change Request 10901, Local Coverage Determinations (LCDs)

CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 - Reasonable and Necessary Provisions in an LCD.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Historically, varicose veins have been treated by conservative measures such as exercise, periodic leg elevation, weight loss, compressive therapy, and avoidance of prolonged immobility. When conservative measures are unsuccessful, and symptoms persist, the next step has been sclerotherapy or surgical ligation with or without stripping. Sclerotherapy involves the injection of a sclerosing solution into the varicose vein(s).

More recently, endoluminal radiofrequency ablation (ERFA) and endoluminal laser ablation have been developed as alternatives to sclerotherapy and surgical intervention. These procedures are designed to damage the intimal wall of the vein resulting in fibrosis and subsequent ablation of the lumen of a segment of the vessel. Both procedures utilize specially designed catheters inserted through a small incision in the distal thigh and advanced, often under ultrasound guidance, nearly to the saphenofemoral junction. The catheter is then slowly withdrawn while controlled radiofrequency or laser energy is applied. This is followed by external compression of the treated segment.

Doppler ultrasound or duplex studies are often used to map the anatomy of the venous system prior to the procedure. There is adequate evidence that pre-procedural ultrasound is helpful, and Medicare will cover 1 ultrasound or duplex scan prior to the procedure to determine the extent and configuration of the varicosities when it is medically necessary.

Evidence and clinical experience support the use of ultrasound guidance during the procedure, and show that the outcomes may be improved and complication rates may be minimized when ultrasound guidance is used. The CPT codes for radiofrequency and laser include the intra-operative ultrasound service in the evaluation, and ultrasound may not be billed separately with these procedures.

A duplex ultrasound examination is considered medically necessary and will be allowed when performed within 1 week (preferably within 72 hours) of EFRA to check for any evidence of thrombus extension from the saphenofemoral junction into the deep system.

  1. Indications for surgical treatment and sclerotherapy:
    1. A 3-month trial of conservative therapy such as exercise, periodic leg elevation, weight loss, compressive therapy, and avoidance of prolonged immobility where appropriate, has failed, AND
    2. The patient is symptomatic and has 1, or more, of the following:
      1. Pain, aching, cramping, burning, itching and/or swelling during activity or after prolonged standing severe enough to impair mobility
      2. Recurrent episodes of superficial phlebitis
      3. Non-healing skin ulceration
      4. Bleeding from a varicosity
      5. Stasis dermatitis
      6. Refractory dependent edema
    3. The treatment of spider veins/telangiectasis will be considered medically necessary only if there is associated hemorrhage.
  2. Indications for ERFA or laser ablation:

    In addition to the above (see A), the patient's anatomy and clinical condition are amenable to the proposed treatment including ALL of the following:
    1. Absence of aneurysm in the target segment.
    2. Maximum vein diameter of 20 mm for ERFA or 30 mm for laser ablation.
    3. Absence of thrombosis or vein tortuosity, which would impair catheter advancement.
    4. The absence of significant peripheral arterial diseases.
  3. Limitations for ERFA and laser ablation:
    1. ERFA and laser ablation are covered only for the treatment of symptomatic varicosities of the lesser or greater saphenous veins and their tributaries which have failed 3 months of conservative therapy.
    2. Intra-operative ultrasound guidance is not separately payable with ERFA, laser ablation.
    3. The treatment of asymptomatic varicose veins, or symptomatic varicose veins without a 3-month trial of conservative measures, by any technique, will be considered cosmetic and therefore not covered.
    4. The treatment of spider veins or superficial telangiectasis by any technique is also considered cosmetic, and therefore not covered unless there is associated bleeding.
    5. Coverage is only for devices specifically FDA-approved for these procedures.
    6. One pre-operative Doppler ultrasound study or duplex scan will be covered.
    7. Post –procedure Doppler ultrasound studies will be allowed if medically necessary.

The stab phlebectomy of the same vein performed on the same day as endovenous radiofrequency or laser ablation may be covered if the criteria for reasonable and necessary as described in this LCD are met.

If sclerotherapy is used with endovenous ablation, it may be covered if the criteria for reasonable and necessary as described in this LCD are met.

The treatment of asymptomatic veins with endoluminal ablation or sclerotherapy is not considered medically reasonable and necessary. If it is determined on review that the varicose veins were asymptomatic, the claim will be denied as a noncovered (cosmetic) procedure.
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
View Letter
N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

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Revenue Codes

Code Description

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

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Group 1

Group 1 Paragraph:

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 Group 1 Codes:

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

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

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Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

1. Each claim must be submitted with a diagnosis code(s) that reflects the condition of the patient and indicates the reason(s) for which the service was performed.

2. The patient's medical record must contain a history and physical examination supporting the diagnosis of symptomatic varicose veins, and the failure of an adequate (at least 3 months) trial of conservative management.

3. The medical record must document the performance of appropriate tests, if medically necessary, to confirm the pathology of the vascular anatomy.

4. This documentation must be made available to Medicare upon request.

5. The HCPCS/CPT code(s) may be subject to Correct Coding Initiative (CCI) edits. This policy does not take precedence over CCI edits. Please refer to the CCI for correct coding guidelines and specific applicable code combinations prior to billing Medicare.

6. When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary under Section 1862(a)(1) of the Social Security Act.

7. When requesting a written redetermination (formerly appeal), providers must include all relevant documentation with the request.
Sources of Information

Other Contractor policies
Bibliography

Chandler JG, Pichot O, Sessa C, et al. Defining the role of extended saphenofemoral junction ligation: a prospective comparative study. Vasc Surg. 2000;32:941-953.

Lurie F, Creton D, Eklof B, et al. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population. J Vasc Surg. 2003;38:207-14.

Merchant RF, DePalma RG, Kabnick LS. Endovascular obliteration of saphenous reflux: a multicenter study. J Vasc Surg. 2002;35(6):1190-6.

Min RJ, Khilnani N, Zimmet SE. Endovenous laser treatment of saphenous vein reflux. Long term results. J Vasc Interv Radiol. 2003;14:991-96.

Raju S, Neglen P. Chronic venous insufficiency and varicose veins. N Engl Med. 2009;360:2319-27.

Rautio T, Ohinmaa A, Perala J, et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs. J Vasc Surg. 2002;35(5):958-965.

Sybrandy JE, Wittens CH. Initial experiences in endovenous treatment of saphenous vein reflux. J Vasc Surg. 2002;36(6):1207-1210.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
08/31/2023 R14

Posted 08/31/2023: Review completed with no change in coverage. Grammar and punctuation corrections made throughout the LCD. Moved references listed under Sources of Information to Bibliography and updated to reflect correct AMA formatting guidelines.
  • Other (Review)
09/30/2021 R13

09/30/2021 Review completed 08/09/2021. Grammar and punctuation corrections made throughout the LCD with no change in coverage.
  • Other (Review)
11/01/2019 R12

Content has been moved to the new template.
  • Revisions Due To Code Removal
08/29/2019 R11

08/29/2019 Change Request 10901 Local Coverage Determinations (LCDs): it will no longer be appropriate to include Current Procedure Terminology (CPT)/Health Care Procedure Coding System (HCPCS) codes or International Classification of Diseases Tenth Revision-Clinical Modification (ICD-10-CM) codes in the LCDs. All CPT/HCPCS, ICD-10 codes, and Billing and Coding Guidelines have been removed from this LCD and placed in Billing and Coding: Treatment of Varicose Veins of the Lower Extremities linked to this LCD. The applicable manual/regulation has been referenced in CMS National Coverage Policy Section. Review completed 08/08/2019. There will not be a lapse in coverage and there has been no change to the coverage content of this LCD.
  • Other (Changes in response to CMS Change Request 10901, Review completed.)
10/01/2018 R10

10/01/2018 Annual review completed 09/04/2018 with no change in coverage. Format change completed.
  • Other (Annual Review)
07/01/2018 R9

 

07/01/2018 Added ICD-10 I83.215 to Group 1 effective 10/01/2015.
  • Revisions Due To ICD-10-CM Code Changes
01/01/2018 R8

 

01/01/2018 CPT/HCPCS code updates: Added codes 36465, 36466, 36482, and 36483 to Group 1 codes. Description changes for Group 1 codes 36468, 36470, and 36471. Added codes 36465, 36466, 36482, and 36483 to Group 1 Paragraph. Typographical error corrected.

 
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2017 R7

10/01/2017 ICD-10 code updates, description changes for Group 1 codes I83.811, I83.812, I83.891, and I83.892 effective 10/01/2017. Annual review completed 09/05/2017. 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 policy.
  • Revisions Due To ICD-10-CM Code Changes
  • Other (annual review)
01/01/2017 R6 01/01/2017 CPT code updates added codes 36473 and 36474, description changes for codes 36476 and 36479 deleted code 93965. Annual review 11/02/2016.

  • Revisions Due To CPT/HCPCS Code Changes
  • Other (CPT code changes, annual review)
12/01/2015 R5 12/01/2015 Annual review, removed CAC information, removed CPT codes from the body of the LCD, no change to coverage.
  • Other (Maintenance annual review)
10/01/2015 R4 10/06/2015 - Due to CMS guidance, we have removed the Jurisdiction 8 Notice and corresponding table from the CMS National Coverage Policy section. No other changes to policy or coverage.
  • Other
10/01/2015 R3 05/29/2015 – Annual updates to the Bill Type Codes and Revenue Codes have been reviewed by the Policy Department and are being Approved for public display. No other changes to policy or coverage.
  • Other (Annual Bill Type Code and Revenue Code updates.)
10/01/2015 R2 02/01/2015 Code 36468 description change, punctuation or spacing.
  • Other
10/01/2015 R1 12/01/2014 annual review updated sources of information and added CAC information, no change in coverage
  • Other (Other annual review)
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Associated Documents

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Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
08/23/2023 08/31/2023 - N/A Currently in Effect You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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