Medical Policy: 01.01.17
Original Effective Date: September 2009
Reviewed: September 2018
Revised: September 2018
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.
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. (E0650)
- 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. (E0651)
- Single or multi-chamber programmable or self-calibrating 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. (E0652)
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 or extensive scarring that prevents them from receiving satisfactory treatment from a non-segmented or segmented device without manual control due to safety concerns. This policy addresses various conditions for which pneumatic compression devices have been investigated for use.
There is insufficient evidence in the peer-reviewed literature that segmental compression pumps with calibrated, gradient pressure two-phase lymph preparation and drainage therapy devices provide outcomes equal or superior to standard pneumatic compression devices. One randomized, single-center, crossover study involving 10 patients that compared the efficacy of the Flexitouch™ device to massage for treatment of lymphedema of the arm was found in the literature. The study was limited by small sample size, short duration of treatment and no comparison to standard pneumatic lymphedema pumps or complex lymphedema therapy. Another similar study compared pressure delivered to parts of the arm between a segmental compression pump and the Flexitouch device. Differences in delivered pressures between the two devices was observed, but no conclusion regarding the optimal pressure needed was made.
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.
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.
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 when standard compression bandaging has not been of benefit.
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.
This technique is also used to stop blood clots developing after surgery in the home setting. The review of trials found conflicting evidence about whether or not pneumatic compression is equivalent to pharmacological prophylaxis in higher risk patients, and there are no studies that show improved health outcomes for low risk individuals over early ambulation.
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 massage, 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:
- 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]
- 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]
- 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]
- 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]
- 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]
Canadian Agency for Drugs and Technologies in Health (CADTH)
Rapid response 2017: The evidence suggested that intermittent pneumatic compression (IPC) may not provide additional benefits when used in combination with routine management of lymphedema. No literature for the comparative clinical effectiveness between single chamber and multi-chamber IPC devices was identified. A 2014 evidence-based guideline recommended the short-term use of IPC in combination with a lymphedema treatment program for reducing breast cancer-related lymphedema. The evidence from the included systematic reviews and randomized controlled trials suggested that IPC may not provide additional benefits when used in combination with the routine management of 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:
- Daily use of an appropriate compression bandage or compression garment providing 30mmHg, AND
- Exercise, AND
- Daily elevation of the affected limb: AND
- The treating physician documents there has been no significant improvement AND significant symptoms remain after a four week trial.
Single or multichamber programmable pneumatic compression devices/lymphedema pumps (E0652) 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 . This would only be considered for patients with:
- Extensive scarring or contracture of the treatment area, AND
- When the scarring or contracture does not allow for standard segmented pneumatic compression therapy, therefore the chamber covering the scarring or contracture can be adjusted to allow for therapy
The lower pressure level of compression frequently used with calibrated pumps (20-30mmHG) has not been shown to be more effective than standard compression therapy. Discomfort alone is not a medically necessary indication for programmable/self-calibrating pneumatic compression therapy.
The use of calibrated pumps will be considered not medically necessary in all other clinical situations including but not limited to groin edema involvement.
There is not sufficient scientific unbiased evidence that calibrated pumps (E0652) are more effective in treating lymphedema. The level of compression when extremely decreased in the calibrated pumps does not provide a level of compression proven to improve lymphedema. A 2-phase lymph preparation and drainage therapy device (e.g., Flexitouch Device, Tactile Systems Technology, Minneapolis, MN; LymphaPress Optimal, Lympha Press USA, Manalapan, NJ) is considered equally effective to standard segmented pneumatic compression devices with calibrated gradient pressure. The ACTitouch Adaptive Compression Therapy System has been shown to be equally effective to standard segmented pneumatic compression devices without calibrated gradient pressure.
The use of pneumatic compression devices/lymphedema pumps to treat the trunk, chest, head or neck 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 and chest or head and neck 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 therapy 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
- Diabetic neuropathic ulcers
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
- 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 2005 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 (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 Position Statement of the National Lymphedema Network for the Diagnosis and Treatment of Lymphedema.
- UpToDate. Prevention and Treatment of Lymphedema. Emile R. Mohler III, M.D., Tammy E. Mondry, DPT, MSRS, CLT-LANA. Topic last updated May12, 2015.
- UpToDate. Compression 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 Product Brief: Flexitouch System (Tactile Systems Technology, Inc.) for Treating Lymphedema. March 2014.
- Medscape. Lymphedema 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. A Randomized Clinical Trial Comparing Advanced Penumatic Truncal, Chest, and Arm Treatment to Arm Treatment Only in Self-Care of Arm Lymphedema. January 2012.
- PubMed. Intermittent Pneumatic Compression Fracture and Soft Tissue Injuries Healing.
- PubMed. The Effect of Intermittent Pneumatic Compression on Fracture Healing.
- PubMed. Cyclic Pneumatic Soft Tissue Compression Enhances Recovery Following Fracture of the Distal Radius: A Randomized Controlled trial.
- PubMed. Use of Intermittent Pneumatic Compression for Treatment of Upper Extremity Vascular Ulcers.
- PubMed. Treating Sensory Impariments in the Post Stroke Upper Limb with Intermittent Pneumatic Compression. Results of Preliminary Trial.
- American Heart Association/American Stroke Association Interventions 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 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. Custom Product Brief. Flexitouch System (Tactile Systems Technology, Inc.) for treating lymphedema. January 2016.
- ECRI Institute. Custom Hotline Response. Thigh-length versus calf-length versus foot-only pneumatic compression devices for preventing deep vein thrombosis. May 5, 2015.
- Feist WR, et al. Problems with measuring compression device performance in preventing deep vein thrombosis. Throm Res 2011 Sep;128(3):207-9.
- Morris RJ, Woodcock JP. Evidence-Based Compression: Prevention of Stasis and Deep Vein Thrombosis. Annals of Surgery. 2004;239(2):162-171. doi:10.1097/01.sla.0000109149.77194.6c.
- American Academy of Orthopaedic Surgeons. (2011). Preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. Evidence-based guideline and evidence report.
- Nelson EA, Hillman A, Thomas K. Intermittent pneumatic compression for treating venous leg ulcers. Cochrane Database Syst Rev. 2014;5:CD001899. PMID 24820100
- Dolibog P, Franek A, Taradaj J, et al. A comparative clinical study on five types of compression therapy in patients with venous leg ulcers. Int J Med Sci. 2014;11(1):34-43. PMID 24396284
- Queensland Health. Lymphoedema clinical practice guideline 2014: the use of compression in the management of adults with lymphoedema [Internet]. Brisbane (AU): Queensland Health; 2014 [cited 2017 Apr 21].
- Gurdal SO, Kostanoglu A, Cavdar I, Ozbas A, Cabioglu N, Ozcinar B, et al. Comparison of intermittent pneumatic compression with manual lymphatic drainage for treatment of breast cancer-related lymphedema. Lymphat Res Biol. 2012 Sep;10(3):129-35.
- Taradaj J, Rosinczuk J, Dymarek R, Halski T, Schneider W. Comparison of efficacy of the intermittent pneumatic compression with a high- and low-pressure application in reducing the lower limbs phlebolymphedema. Ther Clin Risk Manag [Internet]. 2015 [cited 2017 Apr 20];11:1545-54.
- Rogan S, Taeymans J, Luginbuehl H, Aebi M, Mahnig S, Gebruers N. Therapy modalities to reduce lymphoedema in female breast cancer patients: a systematic review and metaanalysis. Breast Cancer Res Treat. 2016 Aug;159(1):1-14.
- Canadian Agency for Drugs and Technologies in Health: CADTH Rapid Response Intermittent Pneumatic Compression Devices for the Management of Lymphedema, May 2017.
- September 2018- Annual Review, Policy Revised
- September 2017- Annual Review, Policy Revised
- 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
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