Highmark Commercial Medical Policy - Pennsylvania


 
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Medical Policy: S-55-041
Topic: Surgical Treatment of Varicose Veins
Section: Surgery
Effective Date: January 1, 2017
Issue Date: January 2, 2017
Last Reviewed: March 2016

A variety of treatment modalities are available to treat varicose veins/venous insufficiency, including surgical approaches, thermal ablation, and sclerotherapy. The application of each of these treatment options is influenced by the severity of the symptoms, type of vein, source of venous reflux, and the use of other (prior or concurrent) treatments.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

General medical necessity criteria for coverage of symptomatic varicose veins

Varicose vein treatment may be considered medically necessary when ALL of the following general criteria are met for any and all varicose vein treatment.  All criteria need to be documented in the patient's medical record and available upon request.

  • Treatment for symptomatic varicose veins is eligible for reimbursement when the patient presents with evidence of at least ONE (1) of the following:
    • Documented limitations of activities of daily living caused by persistent severe lower extremity symptoms attributable to the varicose vein(s)(including but not limited to ache, pain, tightness, skin irritation, heaviness, muscle cramps) that fail to respond to conventional treatment; or
    • Ulceration secondary to venous stasis; or
    • Hemorrhage or recurrent bleeding episodes from  ruptured superficial varicosity; or
    • Recurrent superficial thrombophlebitis that fails to respond to conservative treatment; and
  • The clinical documentation must indicate at least three (3) months of failed conservative treatment and include ALL three (3) of the following:
    • Gradient compression garments providing a minimum of 20-30 mmHg pressure; and
    • Leg elevation above heart level as often as possible; and
    • Walking/exercising regularly as often as possible; and
  • Any incompetence/reflux in the superficial system veins (great saphenous veins (GSV) and small saphenous veins (SSV) and saphenous tributaries) must be documented by venous studies; and
    • There is demonstrated saphenous reflux and Clinical, Etiology, Anatomy, Pathophysiology (CEAP) class C2 or greater; and
  • Photographs are required on any affected areas of the leg (protruding varicose veins), and must be consistent with the submitted clinical description. A measuring device (ruler) must be included in the picture; as well as visual evidence of varicose vein size of at least 5mm in diameter with bulging above the surface of the skin. Photos are not required to approve endovenous ablation, echosclerotherapy, or subfascial endoscopic perforator surgery (SEPS); and  
  • Treatment sessions
    • Requests for coverage of initial sessions are as follows:
      • A bilateral session, or one (1) initial operative session for each leg; or
    • After the clinical outcome of prior treatment(s) has been established and documented, requests for additional operative sessions one (1) session at a time will be considered. Each additional request must meet ALL coverage criteria. If conservative treatment has already been met for a previous surgery, conservative treatment does not need to be met again. All documentation must be maintained in the patient's medical record and available upon request; or
    • Each treatment session should address as much abnormality as is appropriate and reasonable, and may include more than one (1) modality; or
    • If endovenous ablation is requested, one (1) session per each GSV or SSV is appropriate. A maximum of four (4) sessions may be authorized. Medical necessity of the vein to be treated must be established; and
  • Imaging
    • A Doppler ultrasound or duplex study performed no more than 12 months prior to the procedure may be considered medically necessary prior to the treatment session(s) to map the anatomy of the venous system and evaluate for deep and superficial venous incompetence, when all the other general criteria above outlining when treatment for symptomatic varicose veins is eligible for reimbursement are met; and
    • The four (4) components that should be included in the complete duplex scanning examination for chronic vascular disease are: 
      • Visibility; and
      • Compressibility; and
      • Venous flow, including measurement of the duration of reflux; and
        • The cutoff value for abnormally reversed venous flow (reflux) in the saphenous, tibial, deep femoral and perforating vein incompetence is
          • at least 500 ms (500 milliseconds outward flow); and
        • The cutoff value for femoral and popliteal vein incompetence is:
          • at least 1 second; and
        • Vein size criterion is:
          • at least 5mm; and
      • Augmentation; and
    • The Doppler ultrasound or duplex must confirm incompetence/reflux and must document vein size at least 5mm in diameter in the vein to be treated. These studies must demonstrate BOTH of the following:
      • Absence of deep venous thrombosis (DVT); and
      • GSV and/or SSV valvular incompetence/reflux that correlates with the individual's symptoms.

Intraoperative ultrasound guidance when performed is an integral part of the primary procedure and is not separately reimbursed.

Follow-up venous studies or ultrasound performed within six (6) months following the most recent ipsilateral treatment, in the absence of complications, are considered not medically necessary, including but not limited to routine confirmation studies following endovenous ablation.

Follow-up venous studies or ultrasound performed six (6) months or longer following the most recent ipsilateral treatment may be considered medically necessary when ALL of the other general criteria above outlining when treatment for symptomatic varicose veins is eligible for reimbursement are met.

When conservative treatments fail to provide relief from symptomatic varicosities and ALL the above general criteria requirements are met, the following options may be considered medically necessary when reported for symptomatic varicose veins. However, in addition to the general medically necessary criteria above, specific requirements for each procedure must also be met and documented in the patient’s medical record.

  • Ligation/stripping and Ambulatory Phlebectomy (i.e., stab, hook, transilluminated powered)
  • Endovenous Radiofrequency, Endovenous Laser Ablation/Treatment (EVLA/EVLT) and Endomechanical Ablation 
  • Accessory Saphenous Veins
  • Echosclerotherapy
  • Sclerotherapy (Liquid or Microfoam) 
  • Subfascial Endoscopic Perforator Surgery(SEPS)

When reported for conditions other than symptomatic varicose veins, these surgical options are considered cosmetic, and therefore, non-covered. This includes the diagnosis of non-symptomatic varicose veins.
 
Surgical treatment of varicose veins on the contralateral extremity is eligible only if that leg is also symptomatic.

Procedure Codes
36470, 36471, 36475, 36476, 36478, 36479, 37500, 37700, 37718, 37722, 37761, 37765, 37766, 37780, 37785, 37799, 76942, 76998, S2202



Ligation/stripping and Ambulatory Phlebectomy (i.e., stab, hook, transilluminated powered)

Veins defined
Superficial system veins defined by the clinical practice guidelines of the Society of Vascular Surgery and American Venous Forum:

  • GSV
  • SSV

Veins covered

  • GSV
  • SSV
  • Saphenous tributaries  

Coverage criteria

  • Photographs are required on any affected areas of the leg (protruding varicose veins), and must be consistent with the submitted clinical description. A measuring device (ruler) must be included in the picture; as well as visual evidence of varicose vein size of at least 5mm in diameter with bulging above the surface of the skin; and 
  • Related incompetent  superficial veins proximal to the incompetent vein to be treated either have been or are being treated concurrently; and
  • ALL of the general medically necessary criteria above outlining when treatment for symptomatic varicose veins is eligible for reimbursement are met.

Ambulatory phlebectomy services, procedures codes 37765 and 37766, are reported based on the number of incisions performed on each extremity. When fewer than 10 incisions are required, report code 37799.

Procedure code 37785 includes the ligation, division, and/or excision of one or more varicose vein clusters and should only be reported once per extremity. Report code 37785 with modifier RT, LT, or 50 as appropriate.

Ligation/stripping, ambulatory phlebectomy (i.e., stab, hook, transilluminated powered) for conditions other than symptomatic veins, are considered cosmetic, and therefore, non-covered. This includes the diagnosis of non-symptomatic varicose veins.

Procedure Codes
37718, 37722, 37700, 37761, 37765, 37766, 37780, 37785, 37799



Endovenous Radiofrequency, Endovenous Laser Ablation/Treatment (EVLA/EVLT) and Endomechanical Ablation

Veins covered

  • GSV
  • SSV

Coverage criteria
Treatment of EITHER the GSV or the SSV may be considered medically necessary for the following indications:

  • GSV symptoms including but not limited to leg/ankle swelling, skin changes, medial venous ulcer; or
  • SSV symptoms including but not limited to lateral ankle and foot swelling, lateral venous ulcer.

After establishing medical necessity for the treatment of these veins, a total of four (4) sessions may be authorized to treat these veins as described below:

  • One treatment session each of the GSV; one session for the left GSV or one session for the right GSV, totaling two (2) sessions.
  • One treatment session each of the SSV; one session for the left SSV or one session for the right SSV, totaling two (2) sessions.

Additional procedures including ligation or sclerotherapy performed in the same treatment session on the same ablated saphenous vein are included in the reimbursement of the ablation procedure.

Procedures on other saphenous vein systems are eligible for reimbursement based on multiple surgery guidelines.

Endovenous radiofrequency obliteration of veins (VNUS), laser obliteration, and endomechanical ablation of incompetent veins (EVLT) include imaging guidance and catheter insertion as part of the overall procedure.

Ultrasound performed within six (6) months following the most recent ipsilateral treatment, in the absence of complications, is considered not medically necessary, including but not limited to, routine confirmation studies following endovenous/endomechanical ablation.

Non-covered
Endovenous ablation procedures are considered cosmetic for all other indications and therefore, non-covered. 

Procedure Codes
36475, 36476, 36478, 36479, 37799



Mechanochemical Ablation (MCA)/(MOCA)

Mechanochemical ablation of any method, of any vein (i.e., ClariVein® system) is considered experimental/investigational and therefore, non-covered. Scientific evidence does not demonstrate the safety and efficacy of this treatment.

Procedure Codes
36473, 36474



Cyanoacrylate Adhesive

Cyanoacrylate adhesive (i.e. VenaSeal® Closure System) of any vein is considered experimental/investigational and therefore, non-covered.  Scientific evidence is insufficient to determine the effects of the technology on health outcomes.

Procedure Codes
37799



Accessory Saphenous Veins

Veins covered

  • Accessory saphenous veins

Treatment of accessory saphenous veins by surgery (ligation and stripping), endovenous radiofrequency or laser ablation may be considered medically necessary for symptomatic varicose veins/venous insufficiency when ALL of the following criteria have been met. 

Coverage criteria

  • Incompetence of the accessory saphenous vein is isolated or the GSV or SSV had been previously eliminated (at least three (3) months); and
  • There is demonstrated accessory saphenous reflux; and
  • Ultrasound demonstrates vein size at least 5 mm in diameter; and
  • There is documentation of one (1) or more of the following indications:
    • Ulceration secondary to venous stasis; or
    • Recurrent superficial thrombophlebitis that fails to respond to conservative therapy; or
    • Hemorrhage or recurrent bleeding episodes from a ruptured superficial varicosity; or
    • Symptomatic varicose veins:
      • Persistent pain, swelling, itching, burning, or other symptoms are associated with saphenous reflux; and
      • The symptoms significantly interfere with activities of daily living; and
      • Conservative management including compression therapy for at least three (3) months has not improved the symptoms.

Non-covered
Treatment of accessory saphenous veins by surgery or endovenous radiofrequency or laser ablation that do not meet the coverage criteria described above is considered cosmetic, and therefore, non-covered.

Procedure Codes
36475, 36476, 36478, 36479, 37718, 37722, 37700, 37761 , 37765, 37766, 37780, 37785, 37799



Echosclerotherapy

Echosclerotherapy may be considered medically necessary for:

Coverage criteria

  • Perforator vein size at least 3.5 mm in diameter; and
  • CEAP Class C5-C6.

Echosclerotherapy is a technique used for perforator veins. During this technique, duplex ultrasound guidance is used to inject a sclerosing agent into varicose veins. Echosclerotherapy performed for any other indication is considered not medically necessary.

Procedure Codes
S2202



Sclerotherapy (Liquid or Microfoam)

Treatment decisions for the use of sclerotherapy should be based upon the CEAP classification system.

Veins covered

  • Small saphenous vein
  • Saphenous tributaries including accessory saphenous veins 

Coverage criteria (liquid or microfoam)

  • Photographs are required on any affected areas of the leg (protruding varicose veins), and must be consistent with the submitted clinical description. A measuring device (ruler) must be included in the picture; as well as visual evidence of varicose vein size of at least 5mm in diameter with bulging above the surface of the skin; and
  • Related incompetent superficial system veins(reflux) proximal to the incompetent vein to be treated either have been or are being treated concurrently; and
  • ALL of the general criteria above outlining when treatment for symptomatic varicose veins is eligible for reimbursement are met; and
  • CEAP Class C3-C6.

Non-covered
Varithena™ is a sclerosant microfoam made with a proprietary gas mix and is considered experimental/investigational, and therefore, not covered. Scientific evidence does not demonstrate the effectiveness of this treatment.

Sclerotherapy (liquid or microfoam) of the following veins is considered experimental/investigational, and therefore, non-covered:

  • GSV
  • Perforator veins (non-echosclerotherapy)

Sclerotherapy (liquid or microfoam) of the following veins is considered cosmetic, and therefore, non-covered:

  • Small veins less than 5mm in diameter
  • Superficial reticular veins and/or telangiectasia veins (spider veins)

Coverage for sclerotherapy (liquid or microfoam) for these indications is limited to a maximum of three (3) sclerotherapy treatment sessions per leg: three (3) treatment sessions for the right leg and three sessions for the left leg.  A total of six (6) sessions may be authorized to treat these veins without additional clinical documentation, when performed within 12 months of the initial invasive varicose vein procedure.

  • The number of medically necessary sclerotherapy injection sessions varies with the number of anatomical areas that have to be injected, as well as the response to each injection.
  • Usually one to three injections is necessary to obliterate any vessel, and 10 to 40 vessels, or a set of up to a maximum of 20 injections in each leg, may be treated in any one session.
  • Requests for additional sclerotherapy sessions are subject to medical necessity review.

Requests for additional sclerotherapy (liquid or microfoam) treatment, extending beyond the maximum three (3) treatment sessions per leg, may be considered for coverage when ALL of the following additional criteria have been met. All documentation must be maintained in the patient's medical record and available upon request:

  • Additional documentation confirms persistence of symptoms despite prior invasive treatment; and
  • Doppler or Duplex reports and/or standing photographs confirm persistent veins at least 5 mm in diameter; and
  • Evidence of a clearly defined treatment plan including the procedure codes for the planned intervention.

Requests for treatment sessions extending beyond one year (12 months) from the initial invasive treatment session may be similarly subject to a new medical necessity review. All documentation must be maintained in the patient's medical record and available upon request.

Reimbursement

  • Sclerotherapy performed by the surgeon, his associate or, the assistant surgeon during the postoperative period following vein ligation and stripping procedures is part of the global surgical allowance.
  • Ultrasound or duplex scanning is considered medically necessary when initially performed to determine the extent and configuration of varicose veins. However, ultrasound or radiologically guided or monitoring techniques are not considered medically necessary and are not separately payable when performed solely to guide the needle or introduce the sclerosant into the varicose veins.
  • Surgical treatment of varicose veins on the contralateral extremity is eligible only if that leg is also symptomatic.

Code 36470

  • Sclerotherapy for one (1) vein on the same leg.
  • Report this code only once per leg.
  • Includes the cost of the sclerosing agent.
  • Surgical treatment of varicose veins on the contralateral extremity is eligible only if that leg is also symptomatic.

Code 36471

  • Sclerotherapy for multiple veins on the same leg.
  • Report this code only once per leg.
  • Includes the cost of the sclerosing agent.
  • Surgical treatment of varicose veins on the contralateral extremity is eligible only if that leg is also symptomatic.

Code 36470 reported with J3490, Code 36471 reported with J3490

  • Code 36470, includes the cost of the sclerosing agent, therefore when code J3490 is reported in addition to code 36471, no additional allowance will be made.
  • Code 36471, includes the cost of the sclerosing agent, therefore when code J3490 is reported in addition to code 36471, no additional allowance will be made.
  • When reporting Code J3490, please include the name of the drug in the narrative section of the electronic or paper claim.

Modifier 59 reported with code J3490

  • Modifier 59 may be reported with code J3490 to identify it as a significant, separately identifiable service from the sclerotherapy.
  • When the 59 modifier is reported, the patient's records must clearly document that an injection was provided as a separately identifiable service.
Procedure Codes
36470, 36471, 76942, J3490



Subfascial Endoscopic Perforator Surgery (SEPS)

Perforator Veins
Subfascial endoscopic perforator surgery may be considered medically necessary as a treatment of leg ulcers associated with chronic venous insufficiency when the following criteria have been met.

Coverage criteria

  • There is demonstrated perforator reflux; and
  • The superficial saphenous veins (GSV, SSV, or accessory saphenous and symptomatic varicose tributaries) have been previously eliminated; and
  • Ulcers have not resolved following combined superficial vein treatment and compression therapy for at least three (3) months; and
  • The venous insufficiency is not secondary to deep venous thromboembolism (DVT).

Ligation or ablation of incompetent perforator veins performed concurrently with superficial venous surgery is not considered medically necessary.

Procedure Codes
37500



Other Non-covered Services

Treatment of Spider Veins
Treatment for reticular veins and/or superficial telangiectasia’s, including laser, is considered cosmetic, and therefore, non-covered.

  • The injection of sclerosing solution into telangiectasia’s such as spider veins, hemangiomata and angiomata should be reported with code 36468.
  • Laser destruction of reticular veins and/or telangiectasia’s (e.g., VascuLite) should be reported with code 37799.

Procedure codes 17106-17108 should not be used to report the treatment of reticular veins and/or spider veins.

Procedure Codes
17106, 17107, 17108, 36468, 37799



Non-Invasive Laser Treatment

Non-invasive laser treatment of veins is not covered. This method of treatment, e.g., Vasculite Nd Yag, intense pulsed light (IPL), performed for small superficial, reticular, and telangiectatic veins is considered cosmetic, and therefore, non-covered.

In addition, this method of treatment for larger veins is considered experimental/investigational, and therefore, non-covered. Scientific evidence does not demonstrate the effectiveness of this treatment.

Procedure Codes
37799



Refer to the Table Attachment for the CEAP Classification and additional information.

Refer to the following Medical Policy Bulletins for additional information:

  • E-9 Non-Custom/Custom-Made Gradient Compression Garments/Stockings
  • S-100 Multiple Surgical Procedures
  • S-28 Cosmetic Surgery vs. Reconstructive Surgery


Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Surgical treatment of varicose veins is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

A network provider can bill the member for the cosmetic service.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages
If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.



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