Medical Policy: 01.01.17 
Original Effective Date: September 2009 
Reviewed: September 2016 
Revised: September 2016 


Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.


Description:

Pneumatic compression pumps are proposed as a treatment option for patients with lymphedema who have failed conservative measures. They are also proposed to supplement standard of care for patients with venous ulcers. A variety of pumps are available; they can be single chamber (non-segmented) or multi-chamber (segmented) and have varying design and complexity. 

 

Pneumatic compression devices consist of an inflatable garment for the arm, leg, trunk, or chest and an electrical pneumatic pump that fills the garment with compressed air.  The garment is intermittently inflated and deflated with cycle times and pressures that vary between devices.  

 

There are 3 primary types of pumps:

  • Single chamber (non-segmented) non-programmable pumps: These are the simplest pumps, consisting of single chamber that is inflated at one time that applies uniform pressure.
  • Multi-chamber (segmented) non-programmable pumps: These pumps have multiple chambers, ranging from 2 to 12 or more. The chambers are inflated sequentially and have a fixed pressure in each compartment. They either have the same pressure in each compartment or a pressure gradient, but they do not include the ability to manually adjust the pressure in individual compartments.
  • Single or multi-chamber programmable pumps: These are similar to the pumps described except it is possible to make manual adjustments in the pressure in the individual compartment and/or the length and frequency of the inflation cycles.

In general, a non-segmented or segmented compression device without manual control is considered sufficient to meet the needs of the individual.  Typically, the only time a segmented, calibrated gradient pressure device would be indicated is when the individual has contractures, significant scarring or another unique characteristic that prevents them from receiving satisfactory treatment from a non-segmented or segmented device without manual control. This policy addresses various conditions for which pneumatic compression devices have been investigated for use.

 

Lymphedema

Lymphedema is caused by an abnormality of the lymphatic system leading to excessive build-up of tissue fluid that forms lymph, known as interstitial fluid. Stagnant lymph fluid contains protein and cell debris that causes swelling of affected tissues. Left untreated, lymphedema leads to chronic inflammation, infection and hardening of the skin that, in turn, results in further lymph vessel damage and distortion of the shape of affected body parts.

 

Interstitial fluid can build up in any area of the body that has inadequate lymph drainage and cause lymphedema. Lymphedema is a condition that develops slowly and once present is usually progressive. 

 

Lymphedema is divided into two broad classes according to etiology:

  • Primary lymphedema is relatively uncommon and typically arises out of congenital anomalies or developmental abnormalities. 
  • Secondary lymphedema results from the destruction of or damage to formerly functioning lymphatic channels such as surgery for malignant tumors, removal of lymph nodes, post radiation fibrosis, and trauma.

Although the impact of arm/extremity lymphedema has been well studied and documented, very little attention has been focused on the impact of trunk (truncal) and chest edema. There is insufficient evidence that treating the truncal/chest area in addition to the limb affected by lymphedema improves the outcomes of pneumatic compression pump therapy more than only treating the limb.  Further research is indicated and clinically meaningful reductions in truncal girth should also be defined. 

 

Conservative measures for the treatment of lymphedema include, but are not limited to elevation of the affected limb, exercise, massage, and use of a compression bandage system or compression garment.  

 

Summary: The evidence on pneumatic compression pumps applied to the limb for patients with lymphedema includes randomized controlled trials (RCTs) and systemic reviews of RCTs. Relevant outcomes are symptoms, change in disease status, functional outcomes and quality of life. The majority of these RCTs were rated as moderate to high quality by an Agency for Healthcare Research and Quality review, and about half reported significant improvement with pumps compared with conservative care. The evidence is sufficient to determine qualitatively that the technology results in meaningful improvement in the net health outcome. 

 

Based on the peer reviewed medical literature the role of trunk or chest pneumatic compression therapy in the treatment of lymphedema is lacking, the clinical effectiveness of these devices cannot be determined and their role in the management of lymphedema has not been established and further research is indicated and therefore, is considered investigational. 

 

Chronic Venous Insufficiency with Venous Stasis Ulcers

Chronic venous insufficiency (CVI) of the lower extremities is a condition caused by abnormalities of the venous wall and valves, leading to obstruction or reflux of blood flow in the veins.  Signs of CVI include hyperpigmentation, stasis dermatitis, chronic edema, and venous ulcers. 

 

Compression therapy remains the cornerstone of management for patients with chronic venous insufficiency, particularly those with venous ulceration. The goals of treatment are ulcer healing, reduction of edema, and improvement of pain. Prior to using compression therapy, it is important to confirm that the ulcer is due to chronic venous insufficiency rather than ischemia, or of mixed origin. Compression therapy is contraindicated in patients with peripheral artery disease. 

 

Conservative measures for the treatment of venous stasis ulcers includes a compression bandage system or compression garment, appropriate dressings for the wounds, exercise, and elevation of the affected limb.

 

Summary: While there is limited evidence in the peer-reviewed medical literature supporting the efficacy of pneumatic compression devices for the treatment of patients with refractory edema from chronic venous insufficiency (CVI) with significant ulceration of the lower extremities who have failed standard therapy (i.e., a compression bandage system or garment, dressings for the wounds, exercise, and elevation of the limb), these devices are considered standard of care for this subset of patients in the home setting and therefore, considered medically necessary.

 

There is insufficient evidence in the published, scientific literature to support the safety and/or effectiveness of pneumatic compression devices in the treatment of other conditions (e.g., peripheral artery disease/arterial insufficiency, diabetic neuropathic ulcers of the lower extremities, fracture and soft-tissue healing, restless leg syndrome, rehabilitation for distal radial fracture, management of edema following femero-popliteal bypass surgery, treatment of sensory impairment in upper limb following a stroke and treatment of upper extremity vascular ulcers) and therefore, considered investigational. 

 

Practice Guideline and Position Statements

International Union of Phlebology (IUP)

A 2013 Consensus statement from the International Union of Phlebology (IUP) stated that primary lymphedema can be managed effectively by a sequenced and targeted management program based on a combination of decongestive lymphatic therapy and compression therapy. Treatment should include: compression garments, self message, skin care, exercises, and, if desired, pneumatic compression therapy applied in the home.

 

Society for Vascular Surgery

In 2014 Society of Vascular Surgery issued a clinical practice guideline for the management of venous leg ulcers that states:

  1. In a patient with a venous leg ulcer, the Committee recommends compression therapy over no compression therapy to increase venous leg ulcer healing rate. [Grade - 1; Level of Evidence - A]
  2. In a patient with a healed venous leg ulcer, the Committee suggests compression therapy to decrease the risk of ulcer recurrence. [Grade - 2; Level of Evidence - B]
  3. The Committee suggests the use of multicomponent compression bandage over single-component bandages for the treatment of venous leg ulcers. [Grade - 2; Level of Evidence - B]
  4. In a patient with a venous leg ulcer and underlying arterial disease, the Committee does not suggest compression bandages or stockings if the ankle-brachial index is 0.5 or less or if absolute ankle pressure is less than 60 mm Hg. [Grade - 2; Level of Evidence - C]
  5. The Committee suggests use of intermittent pneumatic compression when other compression options are not available, cannot be used, or have failed to aid in venous leg ulcer healing after prolonged compression therapy. [Grade - 2; Level of Evidence - C]

Prior Approval:

 

Not applicable


Policy:

Lymphedema:

Single compartment or multi-chamber nonprogrammable pneumatic compression devices/lymphedema pumps for the treatment of lymphedema may be considered medically necessary when all of the following are met:

  • The patient has undergone a four-week trial of conservative therapy which includes:
    • Use of an appropriate compression bandage or compression garment,
    • Exercise,
    • Elevation of the limb: AND 
  • The treating physician determines there has been no significant improvement or significant symptoms remain after the four-week trial.

Single or multichamber programmable pneumatic compression devices/lymphedema pumps may be considered medically necessary for the treatment of lymphedema when:

  • The individual is otherwise eligible for nonprogrammable pumps; AND
  • There is documentation that the individual has unique characteristics that prevent satisfactory pneumatic compression with single-compartment or multichamber nonprogrammable lymphedema pumps (e.g., significant scarring or contracture).

The use of calibrated pumps will be considered not medically necessary in all other clinical situations.

The use of pneumatic compression devices/lymphedema pumps to treat the trunk or chest in patients with lymphedema limited to the upper and/or lower limbs is considered investigational.

 

Based on the peer reviewed medical literature the role of trunk or chest pneumatic compression therapy in the treatment of lymphedema is lacking, the clinical effectiveness of these devices cannot be determined and their role in the management of lymphedema has not been established and further research is indicated.

 

Chronic Venous Insufficiency with Venous Stasis Ulcers

Pneumatic compression devices (single chamber/nonsegmental) may be considered medically necessary for the treatment of chronic venous insufficiency of the lower extremities with non-healing venous stasis ulcer(s) after a six month trial of conservative therap which includes all of the following:

  • A compression bandage system or compression garment; and
  • Appropriate dressings for the wound; and
  • Exercise; and
  • Elevation of the limb

All other uses of pneumatic compression devices including but not limited to the following are considered investigational because the safety and/or effectiveness of these devices cannot be established by review of the available peer reviewed literature:

  • Peripheral artery disease/arterial insufficiency
  • Restless leg syndrome
  • Management of edema following femoro-popliteal bypass surgery
  • Rehabilitation for distal radial fracture
  • Fracture and soft tissue healing
  • Treatment of sensory impairment in the upper limb following a stroke
  • Treatment of upper extremity vascular ulcers
  • Edema related to obesity


Procedure Codes and Billing Guidelines:

  • To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
  • E0650 Pneumatic compressor, nonsegmental home model
  • E0651 Pneumatic compressor, segmental home model without calibrated gradient pressure
  • E0652 Pneumatic compressor, segmental home model with calibrated gradient pressure
  • E0655 Nonsegmental pneumatic appliance for use with pneumatic compressor, half arm
  • E0656 Segmental pneumatic appliance for use with pneumatic compressor, trunk
  • E0657 Segmental pneumatic appliance for use with pneumatic compressor, chest
  • E0660 Nonsegmental pneumatic appliance for use with pneumatic compressor, full leg
  • E0665 Nonsegmental pneumatic appliance for use with pneumatic compressor, full arm
  • E0666 Nonsegmental pneumatic appliance for use with pneumatic compressor, half leg
  • E0667 Segmental pneumatic appliance for use with pneumatic compressor, full leg
  • E0668 Segmental pneumatic appliance for use with pneumatic compressor, full arm
  • E0669 Segmental pneumatic appliance for use with pneumatic compressor, half leg
  • E0670 Segmental pneumatic appliance for use with pneumatic compressor, integrated, 2 full legs and trunk
  • E0671 Segmental gradient pressure pneumatic appliance, full leg
  • E0672 Segmental gradient pressure pneumatic appliance, full arm
  • E0673 Segmental gradient pressure pneumatic appliance, half leg
  • E0675 Pneumatic compression device, high pressure, rapid inflation/deflation cycle, for arterial insufficiency (unilateral or bilateral system)
  • E0676 Intermittent limb compression device (includes all accessories), not otherwise specified

Selected References:

  • Delis KT, Husmann MJ, Cheshire NJ, Nicolaides AN. Effects of intermittent pneumatic compression of the calf and thigh on arterial calf inflow: a study of normals, claudicants, and grafted arteriopaths. Surgery. 2001 Feb;129(2):188-95.
  • Labropoulos N, Wierks C, Suffoletto B. Intermittent pneumatic compression for the treatment of lower extremity arterial disease: a systematic review. Vasc Med. 2002 May;7(2):141-8.
  • Louridas G, Saadia R, Speay J, Abdoh A, et al. The ArtAssist Device in chronic lower limb ischemia. A pilot study. Int Angiol. 2002 Mar;21(1):28-35.
  • Delis KT, Nicolaides AN. Effect of intermittent pneumatic compression of foot and calf on walking distance, hemodynamics, and quality of life in patients with arterial claudication: a prospective randomized controlled study with 1-year follow-up. Ann Surg. 2005 Mar;241(3):431-41.
  • ECRI Institute. ArtAssist Intermittent Pneumatic Compression Device for the Treatment of Lower Extremity Arterial Disease. Plymouth Meeting (PA): ECRI Institute External Site2005 Feb 23. 7 p. [ECRI hotline response].
  • Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, et al.; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC; AHA Task Force on Practice Guidelines; Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): executive summary a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease) endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. J Am Coll Cardiol. 2006 Mar 21;47(6):1239-312.
  • Centers for Medicare & Medicaid Services (CMS). NCD for Pneumatic Compression Devices External Site(280.6). Effective Date April 14, 2002. Accessed March 7, 2011. Rockson SG. Diagnosis and management of lymphatic vascular disease. J.Am.Coll.Cardiol. 2008;52:799-806.
  • Dolibog P, Franek A, Taradaj J et al. A randomized, controlled clinical pilot study comparing three types of compression therapy to treat venous leg ulcers in patients with superficial and/or segmental deep venous reflux. Ostomy Wound Manage 2013; 59(8):22-30.
  • National Lymphedema Network External SitePosition Statement of the National Lymphedema Network for the Diagnosis and Treatment of Lymphedema.
  • UpToDate External SitePrevention and Treatment of Lymphedema. Emile R. Mohler III, M.D., Tammy E. Mondry, DPT, MSRS, CLT-LANA. Topic last updated May12, 2015.
  • UpToDate External SiteCompression Therapy for the Treatment of Chronic Venous Insufficiency. David G. Armstrong, DPM, M.D., PhD, Andrew J. Meyr, DPM. Topic last updated October 5, 2015.
  • ECRI Institute External SiteProduct Brief: Flexitouch System (Tactile Systems Technology, Inc.) for Treating Lymphedema. March 2014.
  • Medscape External SiteLymphedema Treatment and Management. Updated April 22, 2014.
  • Sheila H. Ridner, PhD, R.N., Barbara Murphy, M.D. et. al. Advanced Pneumatic Therapy in Self-Care of Chronic Lymphedema of the Trunk. Lymphatic Research and Biology, Volume 8, Number 4, 2010.
  • PubMed External SiteA Randomized Clinical Trial Comparing Advanced Penumatic Truncal, Chest, and Arm Treatment to Arm Treatment Only in Self-Care of Arm Lymphedema. January 2012.
  • PubMed External SiteIntermittent Pneumatic Compression Fracture and Soft Tissue Injuries Healing.
  • PubMed External SiteThe Effect of Intermittent Pneumatic Compression on Fracture Healing.
  • PubMed External SiteCyclic Pneumatic Soft Tissue Compression Enhances Recovery Following Fracture of the Distal Radius: A Randomized Controlled trial.
  • PubMed External SiteUse of Intermittent Pneumatic Compression for Treatment of Upper Extremity Vascular Ulcers.
  • PubMed External SiteTreating Sensory Impariments in the Post Stroke Upper Limb with Intermittent Pneumatic Compression. Results of Preliminary Trial.
  • American Heart Association/American Stroke Association External SiteInterventions for Sensory Impairment in the Upper Limb after Stroke. November 2010.
  • Alexander te Slaa, et. al.  Prospective Randomized Controlled Trial to Analyze the Effects of Intermittent Pneumatic Compression on Edema Following Autologous Femoropopliteal Bypass Surgery. World Journal of Surgery (2011) 35:446-454 
  • International Union of Phlebology (IUP), Consensus Document of the International Union of Phlebology (IUP) 2013, Diagnosis and Treatment of Primary Lymphedema. Int Angiol 2013 December; 32(6): 541-74.2013
  • O’Donnell Thomas, Passman Marc, Marston William, et. al. Management of Venous Leg Ulcers: Clinical Practice Guidelines of the Society for Vascular Surgery and the American Venous Forum, J Vasc Surg 2014;60:3S-59S
  • Association for the Advancement of Wound Care External Site (AAWC), Venous Ulcer Guide, March 1, 2012.
  • Oremus M, Walker K, Dayes I. Diagnosis and Treatment of Secondary Lymphedema: Technology Assessment report External Site by McMaster University Evidence Based Practice Center Under Contract with the Agency for Healthcare Research and Quality (AHRQ) (Project ID: LYMT0908. 2010.
  • Shao Y, Qi K, Zhou Qh, et. al. Intermittent Pneumatic Compression Pump for Breast Cancer Related Lymphedema a Systemic Review and Meta-Analysis of Randomized Controlled Trials. Oncol Res Treat. 2014;37(4):170-174
  • Uzkeser H, Karatay S, Erdemci B, et. al. Efficacy of Manual Lymphatic Drainage and Intermittent Pneumatic Compression Pump Use in the Treatment of Lymphedema after Mastectomy: A Randomized controlled Trial. Breast Cancer. May 2015;22(3):300-307
  • Nelson EA, Hillman A, Thomas K. Intermittent Pneumatic Compression for Treating Venous Leg Ulcers. Cochrane Database Syst Rev. 2014;5CD001899 
  • Pilch, U, M Wozniewski, A Szuba: Influence of compression cycle time and number of sleeve chambers on upper extremity lymphedema volume reduction during intermittent pneumatic compression. Lymphology 42 (2009), 26-35.
  • ECRI Institute External SiteCustom Product Brief. Flexitouch System (Tactile Systems Technology, Inc.) for treating lymphedema. January 2016.
  • ECRI Institute External SiteCustom Hotline Response. Thigh-length versus calf-length versus foot-only pneumatic compression devices for preventing deep vein thrombosis. May 5, 2015.

Policy History:

  • September 2016 - Annual Review, Policy Revised
  • October 2015 - Annual Review, Policy Revised
  • November 2014 - Annual Review, Policy Revised
  • January 2014 - Annual Review, Policy Revised
  • February 2013 - Annual Review, Policy Renewed
  • February 2012 - Annual Review, Policy Renewed
  • March 2011 - Interim Review, Policy Revised
  • December 2010 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.