Coverage Policy Manual
Policy #: 2010038
Category: DME
Initiated: August 2010
Last Review: August 2018
  Lymphedema Pumps (Pneumatic Compression Devices) for the Treatment of Lymphedema and Venous Ulcers

Description:
Pneumatic compression pumps are proposed as a treatment option for patients with lymphedema who have failed conservative measures e.g., compression garments, manual massage. They are also proposed to supplement standard care for patients with venous ulcers.  A variety of pumps are available; they can be single- or multi-chamber and have varying design and complexity.
 
Lymphedema is an abnormal accumulation of lymph fluid in subcutaneous tissues or body cavities due to obstruction of lymphatic flow. Lymphedema can be subdivided into primary and secondary categories. Primary lymphedema has no recognizable etiology, while secondary lymphedema is related to a variety of causes including surgical removal of lymph nodes, post-radiation fibrosis, scarring of lymphatic channels, or congenital anomalies. Treatment includes mechanical measures (compression garments, bandaging, manual massage, pneumatic compression devices (i.e., lymphedema pumps), drugs, or rarely surgery. Lymphedema pumps consist of pneumatic cuffs that are connected to a pump. They use compressed air to apply pressure to the affected limb. The intention is to force excess lymph fluid out of the limb and into central body compartments in which lymphatic drainage should be preserved. Many different pneumatic compression pumps for treating lymphedema are available, with varying materials, design, degree of pressure, and complexity. There are three primary types of pumps as follows:
 
Venous ulcers, which occur most commonly on the medial distal leg, can develop in patients with chronic venous insufficiency when leg veins become blocked. Standard treatment for venous ulcers includes compression bandages or hosiery supplemented by conservative measures such as leg elevation. Pneumatic compression pumps are proposed as a treatment for venous ulcers, especially in the case of patients who do not respond to these standard therapies.
 
Single-chamber non-programmable pumps: These are the simplest pumps, consisting of a single chamber that is inflated at one time that applies uniform pressure.
Multi-chamber non-programmable pumps: 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 can 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 above except that it is possible to make manual adjustments in the pressure in the individual compartments and/or the length and frequency of the inflation cycles.
 
Recently, a new type of pump has been introduced, a two-stage multi-chamber pump. One device of this type, the Flexitouch™ system (Tactile Systems Technology, Minneapolis, MN), has 27-32 chambers and includes 13 sequential treatment programs for different regions of the body. Treatment sessions consist of 2 phases, meant to simulate manual lymph drainage. The first phase is preparation of the affected area for drainage which uses a proximal-to-distal gradient, and the second phase is drainage which uses a distal-to-proximal gradient. The Flexitouch system includes a variety of garment types. For treating an upper extremity, chest and trunk garments are used in addition to the arm garment. When treating a lower extremity, a trunk garment is used with a calf-foot garment. This allows treatment of the truncal area in addition to the affected limb.
 
Pneumatic compression pumps may be used in lymphedema clinics or purchased or rented for home use. This policy addresses the home use of lymphedema pumps.
 
Regulatory Status
Several pneumatic compression pumps indicated for primary or adjunctive treatment of primary or secondary (e.g., postmastectomy) lymphedema have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Examples of devices with these indications that are intended for home or clinic/hospital use include the Compression Pump, Model GS-128 (Medmark Technologies, LLC, Perkasie, PA); the Sequential Circulator® (Bio Compression Systems, Inc., Moonarchie, NJ); and the Lympha-Press® and Lympha-Press Optimal (Mego Afek, Israel), the Flexitouch™ system (Tactile Systems Technology, Inc.) and the PowerPress Unit Sequential Circulator (Hanuri Distribution, Inc, Chatsworth, CA).
 
Several pneumatic compression devices are cleared by the FDA for treatment of venous stasis ulcers. Examples include the Model GS-128, Lympha-Press, Flexitouch, and PowerPress Unit listed above as well as Nanotherm(TM) (ThermoTek, Inc.), CTU676(R) (Compression Technologies), and Recovery+(TM) (Pulsar Scientific).
  
 
Coding
Claims for lymphedema pumps are coded for with a pair of HCPCS codes: one to describe the actual pump and one to describe the appliance (i.e., sleeve) that is put on the affected body part. The various types of pumps may be distinguished by HCPCS codes.
 
Single compartment pumps:
 
E0650: Pneumatic compressor, nonsegmental home model
 
The above code (E0650) is used in conjunction with any of the following appliances:
E0655: Nonsegmental pneumatic appliance for use with pneumatic compressor, half arm
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
 
Multi-chamber pumps:
 
E0651: Pneumatic compressor, segmental home model without calibrated gradient pressure
 
The above code (E0651) may be used with any of the following appliance codes:
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
 
Multi-chamber programmable pumps:
 
E0652: Pneumatic compressor, segmental home model with calibrated gradient pressure
 
The above code (E0652) may be used with any of the following appliance codes:
E0671: Segmental gradient pressure pneumatic appliance, full leg
E0672: Segmental gradient pressure pneumatic appliance, full arm
E0673: Segmental gradient pressure pneumatic appliance, half leg
 
 

Policy/
Coverage:
Effective September 2017
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Single compartment or multi-chamber nonprogrammable lymphedema pumps  applied to the limb meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of lymphedema that has failed to respond to conservative measures, such as elevation of the limb and use of compression garments.
 
Single compartment or multi-chamber programmable lymphedema pumps applied to the limb meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of lymphedema when:
 
    • The individual is otherwise eligible for non-programmable pumps; and  
    • There is documentation that the individual has unique characteristics that prevent satisfactory pneumatic compression with single-compartment or multi-chamber non-programmable lymphedema pumps (e.g., significant scarring).  
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Lymphedema pumps applied to the limb
Single compartment or multichamber lymphedema pumps applied to the limb in all situations other than those specified above in the first two policy statements do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, single compartment or multichamber lymphedema pumps applied to the limb in all situations other than those specified above in the first two policy statements is considered investigational. Investigation services are specific contract exclusions in most member benefit certificates of coverage.
 
Lymphedema pumps applied to the trunk or chest
The use of lymphedema pumps to treat the trunk (E0656, E0670) or chest (E0657) in patients with lymphedema limited to the upper and/or lower limbs does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, the use of lymphedema pumps to treat the trunk or chest in patients with lymphedema limited to the upper and/or lower limbs is considered investigational. Investigation services are specific contract exclusions in most member benefit certificates of coverage.
 
Lymphedema pumps applied to the head and neck
The use of lymphedema pumps to treat head and neck lymphedema for any indication, including, but not limited to lymphedema related to cancer therapy does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, the use of lymphedema pumps to treat head and neck lymphedema for any indication, including, but not limited to lymphedema related to cancer therapy is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Lymphedema pumps to treat venous ulcers
The use of lymphedema pumps to treat venous ulcers does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes. For members with contracts without primary coverage criteria, the use of lymphedema pumps to treat venous ulcers is considered investigational. Investigation services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective October 2013- August 2017
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Single compartment or multi-chamber nonprogrammable lymphedema pumps  applied to the limb meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of lymphedema that has failed to respond to conservative measures, such as elevation of the limb and use of compression garments.
 
Single compartment or multi-chamber programmable lymphedema pumps applied to the limb meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of lymphedema when:
 
    • The individual is otherwise eligible for non-programmable pumps; and  
    • There is documentation that the individual has unique characteristics that prevent satisfactory pneumatic compression with single-compartment or multi-chamber non-programmable lymphedema pumps (e.g., significant scarring).  
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Single compartment or multichamber lymphedema pumps applied to the limb in all situations other than those specified above in the first two policy statements do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, single compartment or multichamber lymphedema pumps applied to the limb in all situations other than those specified above in the first two policy statements is considered investigational. Investigation services are specific contract exclusions in most member benefit certificates of coverage.
 
The use of lymphedema pumps to treat the trunk (E0656, E0670) or chest (E0657) in patients with lymphedema limited to the upper and/or lower limbs does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, the use of lymphedema pumps to treat the trunk or chest in patients with lymphedema limited to the upper and/or lower limbs is considered investigational. Investigation services are specific contract exclusions in most member benefit certificates of coverage.
 
The use of lymphedema pumps to treat venous ulcers does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, the use of lymphedema pumps to treat venous ulcers is considered investigational. Investigation services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to October 2013
Single compartment or multi-chamber nonprogrammable lymphedema pumps meet member benefit primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of lymphedema that has failed to respond to conservative measures, such as elevation of the limb and use of compression garments.
 
Single compartment or multi-chamber programmable lymphedema pumps meet member benefit primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of lymphedema when:
 
    • The individual is otherwise eligible for non-programmable pumps; and
    • There is documentation that the individual has unique characteristics that prevent satisfactory pneumatic compression with single-compartment or multi-chamber non-programmable lymphedema pumps (e.g., significant scarring).
 
Two-phase multi-chamber lymphedema pumps (e.g., Flexitouch) do not meet member benefit primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for treatment of lymphedema.
 
For contracts without primary coverage criteria, two-phase multi-chamber lymphedema pumps (e.g., Flexitouch) is considered investigational.  Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.
 

Rationale:
This policy is based on a 1998 TEC Assessment that focused on data that compared the efficacy of the three different types of lymphedema pumps. A comparison of the efficacy of lymphedema pumps to other treatments of lymphedema was not addressed by this assessment. The assessment concluded that the minimal amount of available data were inadequate to validate the superiority of one type of lymphedema pump over another. Only 2 trials including direct comparisons of pump types were identified. Zanolla and colleagues compared a single-chamber device and a multi-chamber device without gradient pressures and found no significant difference in efficacy. However, interpretation of this trial is limited by the small number of patients (n=60) and varying range of severity in lymphedema between the treatment groups. In an unpublished trial, Bergan and colleagues used a multi-chamber device with gradient pressure programmed to simulate the other types of lymphedema pumps. A total of 32 patients were treated with the pump sequentially to simulate the different pump types. While the use of the multi-chamber device with gradient pressure was associated with a significant reduction in lymphedema compared to the other simulated pump types, interpretation of this study is limited by lack of appropriate statistical testing, including confidence intervals, and lack of data validating the degree to which the simulated pumps accurately reflect the performance of the true pumps.
 
Among additional uncontrolled studies, heterogeneity in the patient populations, etiology of lymphedema, location of lymphedema, and severity of illness also make it difficult to compare efficacy across the different trials. For example, efficacy of the pumps may differ in the lower extremities as compared to the upper extremities, or as a function of the etiology of lymphedema, particularly in primary versus secondary forms. Differences in severity of illness may be the most important of these factors affecting outcome. For patients with mild edema, the response to any form of therapy will likely be more favorable. Furthermore, the manner in which the response is calculated, i.e., percent reduction in edema, is a relative measure and is therefore dependent on the initial level of lymphedema. Therefore, when using this outcome measure to compare results, it is crucial that the underlying severity of illness is similar among groups being compared in order to draw meaningful conclusions. Despite these limitations, results across all of the studies were consistent in showing a substantial improvement in lymphedema following treatment with any of the pumps tested. It is possible to conclude, therefore, that pneumatic compression devices are efficacious to some degree; however, it is not possible to estimate precisely the magnitude of this effect.
 
In October 2009, the McMaster University Evidence-based Practice Center, under contract with the Agency for Healthcare Research and Quality (AHRQ), published a technology assessment on diagnosis and treatment of secondary lymphedema that included discussion of pneumatic compression pumps (Mayrovitz, 2009). The authors identified a total of 10 studies; 6 moderate-to-high-quality randomized controlled trials, 2 low-quality randomized controlled trials (RCTs), and 2 observational studies. There was a high degree of heterogeneity between studies: 7 types of lymphedema pumps were used, pumps were compared to 6 different alternative interventions (including compression bandages, laser, and massage), and 5 studies used pumps in combination with other interventions. Due to the relatively small number of studies and high degree of variability in study design, the authors concluded that there was insufficient evidence to determine whether one type of IPC device and sleeve was more effective than another type. The literature search did not identify any studies that examined whether treating the truncal area in addition to the affected limb improves the outcomes of pneumatic compression pump treatment.
 
It has been suggested that a failure to treat the trunk may be harmful to patients e.g., leading to the development of new areas of edema in the genitals, abdomen, hips or chest (Mayrovitz, 2009). The AHRQ evidence review included an evaluation of harms associated with treatments for lymphedema (Oremus, 2009). They found that therapy-specific adverse effects occurred in less than 1% of patients. This includes infection, arm thrombosis and headache with elevated blood pressure; the appearance of new areas of edema was not mentioned as an adverse effect reported in trials.
 
Six trials compared the addition of massage, including manual lymphatic drainage (a specialized type of massage performed by a trained therapist), to more conservative treatments such as bandaging or physical therapy. Five of the 6 studies included women with arm lymphedema after breast cancer treatment. Only 1 of these 5 found that massage led to greater reduction in arm volume than more conservative therapy. The sixth trial, which addressed lymphedema after ankle surgery, found significantly greater reduction in volume when manual lymph drainage massage was added to standard physical therapy versus physical therapy alone.
 
Representative randomized controlled trials using FDA-cleared devices are described below:
Johansson and colleagues published an RCT in 1998 that was conducted at a single center in Sweden (Johansson, 1998). Twenty-eight women with unilateral postoperative arm lymphedema (at least 10% greater volume in the affected arm) following breast cancer surgery were randomly assigned to receive manual lymph drainage (MLD) or sequential pneumatic compression (SPC). The pump was the Lympha-Press which had 9 compression cells. All patients initially received 2 weeks of treatment with a compression sleeve. A total of 24 women completed the initial treatment and the 2-week course of MLD or SPC, 12 in each group. Patients in each group experienced a decrease in volume of the arm during treatment; there was a 15% reduction in the manual lymph drainage group and 7% in the sequential pneumatic compression group; the difference between groups was not statistically significant. The study was small and may not have had sufficient statistical power.
 
In 2002, Szuba and colleagues published an article that evaluated the Sequential Circulator lymphedema pump, a 4-chamber device, in 2 RCTs conducted in the U.S. among women with breast cancer (Szuba, 2002).
 
Study 1: The study evaluated initial treatment of women with unilateral lymphedema (an increase of at least 20% in the volume of the swollen arm compared to the normal arm) who had completed cancer therapy at least 12 weeks earlier. Twelve women were randomly assigned to 10 days of outpatient treatment with decongestive lymphatic therapy (a multidisciplinary approach consisting of manual lymph drainage, compression bandaging, and massage) plus use of a lymphedema pump 30 minutes a day at 40-50 mm Hg, and 11 were randomly assigned to decongestive lymphatic therapy alone. At the 2-week follow-up, there was a statistically significant greater reduction in volume of the edematous arm in the group assigned to pump use (45%) compared to the non-pump group (26%), p<0.05. The difference in volume reduction between groups was not significantly different at 40 days at the end of PhaseII; there was a mean reduction of 30% in the pump group and 27% in the non-pump group.
 
Study 2: The study included women who had received a course of decongestive lymphatic therapy at least 1 month and less than 1 year prior to enrollment. Twenty-seven women were randomly assigned; the average duration of lymphedema was 60 months, and the average time from surgery was 114 months. Thirty days of self-administered conservative therapy alone (i.e., lymphatic massage and use of a compression garment) was compared to conservative therapy plus 60 minutes per day of lymphedema pump use. Patients assigned to use lymphedema pumps were supplied with a device for home use. After a month of treatment, patients could cross-over to the other intervention. The authors did not report the number of patients in each treatment group but stated that 25 women completed the study and 2 voluntarily withdrew. During the month of treatment that included pump use, there was a mean volume reduction in the affected limb of 86 mL; there was no apparent effect of treatment order. In contrast, during the month of self-administered conservative treatment alone, there was a mean increase in volume of 33 mL. There were no adverse responses to maintenance treatment with the lymphedema pump; in study 1, one of 11 patients experienced headache and a modest increase in blood pressure during pump use.
 
In 2006, Wilburn and colleagues published a pilot randomized crossover study in 10 women with breast-cancer-associated lymphedema of the arm (at least 10% increased volume in the affected limb) after initial treatment with intensive decongestive physical therapy (Wilburn, 2006). Women were assigned, in random order, to self-administered treatment with the Flexitouch or massage, 1 hour daily for 14 days; they then switched to the other treatment. There was a washout phase of 1 week before each treatment period during which time patients used only a compression garment. The difference in arm volume was significantly higher after treatment with the Flexitouch (mean decrease of 207 mL) than after self-massage (mean increase of 52 mL), p=0.007. The authors state that the positive response to the Flexitouch device in this preliminary trial warrants additional testing in larger studies.
 
In addition to the studies described above, a 2009 RCT by Pilch and colleagues, in Poland, compared lymphedema pumps in terms of number of chambers and cycle times (Pilch, 2009). Fifty-seven women with lymphedema of the arm following breast cancer treatment were randomly assigned to 1 of 4 treatments: 1) one-to-one cycle of compression and interval (90s: 90s) with a single chamber sleeve (n=17); 2) one-to-one cycle of compression and interval (90s: 90s) with a three-chamber sleeve (n=9); 3) three-to-one cycle of compression and interval (45s: 15s) with a single chamber sleeve (n=11); or 4) three-to-one cycle of compression and interval (45s: 15s) with a three-chamber sleeve (n=20). Patients in all groups received 25 intermittent pneumatic compression treatments, performed 5 days a week for 5 weeks. Two models of Flowtron pumps (Huntleigh Healthcare, UK) were used. (These pumps appear to be FDA-cleared for prevention of deep vein thrombosis.) The mean percent edema post-treatment was 29% in group 1, 35% in group 2, 34% in group 3, and 28% in group 4. Overall, there was not a significant difference among groups. However, percent edema was significantly lower in group 3 (45s cycle with a 3 compartment sleeve) than group 4 (45s cycle with a single compartment sleeve). In some situations, including in patients with scarring, contractures or highly sensitive skin, programmable pumps are generally considered to be the preferred option.
 
Summary
The available evidence from randomized controlled trials suggests that use of lymphedema pumps may be effective at reducing limb volume in patients who fail to respond to conservative therapy. There is insufficient evidence from comparative trials that one type of pump is more effective than another. There are limited data available on two-phase multi-chamber pumps and no trials comparing them to other types of pumps.
 
Technology Assessments, Guidelines, and Position Statements
A 2009 Technology Assessment Report by the McMaster University Evidence-based Practice Center for AHRQ had the following conclusions regarding treatment of secondary lymphedema: (Oremus, 2009) “…there was no evidence concerning the optimal criteria to initiate or stop treatment. While the studies suggested that most treatments did reduce the size of the lymphatic limb, there was too much heterogeneity in terms of treatments, inclusion and exclusion criteria, and treatment protocols to suggest the optimality of one type of treatment over another. Despite the multiplicity of inclusion and exclusion criteria, the studies did not contain reports of treatment benefits in any subgroup of patients.” The report did not have specific recommendations on use of lymphedema pumps.
 
In 2001, Health Canada issued breast cancer treatment guidelines that included information on management of lymphedema related to breast cancer (Harris, 2001). Recommendations include encouraging long-term consistent use of compression garments and offers practical advice on skin care, exercise, and body weight. The guideline states that one trial demonstrated a trend in favor of pneumatic compression pumps and that further randomized trials are needed to determine whether pneumatic compression provides additional benefit beyond that offered by compression garments.
 
2012 Update
Pneumatic compression pumps have been proposed as a treatment for venous ulcers.  This policy update addresses this indication.
 
A 2011 Cochrane review addressed intermittent pneumatic compression pumps for treating venous leg ulcers (Nelson, 2011). The review identified a total of 7 RCTs. Four trials compared pneumatic compression pumps plus compression bandages or stockings to compression bandages or stockings only, 1 trial compared compression pumps to wound dressings only and 1 trial compared two intermittent pneumatic compression regimens. The trial comparing pumps to wound dressings, which was not blinded, found a significantly greater rate of wound healing with compression treatment. However, the more relevant comparison intervention is continuous compression provided by bandages or stockings. The 4 trials with this comparison had sample sizes ranging from 22 to 53. Blinding was unclear in 3 of the studies and the fourth was not blinded. In a pooled analysis of 3 of the 4 trials, there was not a statistically significant difference in the number of healed ulcers in the group receiving intermittent pneumatic compression or compression bandaging or stockings only, risk ratio (RR): 1.09 (95% confidence interval [CI]: 0.91-1.30). The fourth trial found a significantly higher healing rate in the pump group than the compression bandage/stocking group; in this trial, the rate of healing with compression bandages/stockings was particularly low.
 
This evidence is insufficient to conclude whether lymphedema pumps improve healing of venous ulcers. Overall, there are few trials that reported on the most relevant clinical comparisons i.e., pneumatic compression as an adjunct to optimal wound care compared to optimal wound care alone. In many studies, it is difficult to ascertain whether optimal wound care was provided in the control group and whether enrolled patients had failed optimal wound care prior to enrollment in the study. The available studies do not consistently show that intermittent pneumatic compression improves ulcer healing. Moreover, many of the studies have methodological limitations such as a lack of blinding or a failure to report on complete ulcer healing. The literature is characterized by a high degree of heterogeneity among studies in the types of pumps used, the protocols for pneumatic compression, the comparison groups, and control interventions. The pumps used in the trials varied and some were older devices used in the the 1980s and 1990s. This creates challenges in classifying the types of devices used. Moreover, it is difficult to compare the pumps in the trials to currently available lymphedema pumps since all but 1 of the studies were published at least 10 years ago and some were from the late 1980s/early 1990s. The policy statement has been changed to address the use of compression pumps for the treatment of venous ulcers.
 
2013 Update
A literature search was conducted using the MEDLINE database through September 2013.  As a result of the search and policy review, the coverage statement has been revised to address treatment of venous ulcers and treatment of the trunk or chest. The following is a summary of the key identified literature.
 
Lymphedema
In 2012, Oremus and colleagues published an updated systematic review on conservative treatments for secondary lymphedema (Oremus, 2012). The authors identified a total of 36 English-language studies, 30 of which were RCTs and 6 were observational studies. Six RCTs evaluated intermittent pneumatic compression. Study findings were not pooled. The authors reported that 2 RCTs showed that IPC was superior to decongestive therapy or self-massage but 3 other RCTs failed to show that IPC was superior to a different type of conservative treatment of lymphedema. In addition, the authors identified 1 RCT comparing types of IPC devices. This study, Pilch et al. 2009 [see description below (Pilch, 2009)] found that a 3-chamber IPC sleeve was superior to a 1-chamber sleeve for reducing edema.
 
Comparison between lymphedema pumps and/or protocols
A 2009 RCT by Pilch and colleagues, in Poland, compared lymphedema pumps in terms of number of chambers and cycle times (Pilch, 2009). Fifty-seven women with lymphedema of the arm following breast cancer treatment were randomly assigned to 1 of 4 treatments: 1) one-to-one cycle of compression and interval (90s: 90s) with a single chamber sleeve (n=17); 2) one-to-one cycle of compression and interval (90s: 90s) with a 3-chamber sleeve (n=9); 3) three-to-one cycle of compression and interval (45s: 15s) with a single chamber sleeve (n=11); or 4) three-to-one cycle of compression and interval (45s: 15s) with a 3-chamber sleeve (n=20). Patients in all groups received 25 intermittent pneumatic compression treatments, performed 5 days a week for 5 weeks. Two models of Flowtron pumps (Huntleigh Healthcare, UK) were used. (These pumps appear to be FDA-cleared for prevention of deep vein thrombosis.) The mean percent edema post-treatment was 29% in group 1, 35% in group 2, 34% in group 3, and 28% in group 4. Overall, there was not a significant difference among groups. However, percent edema was significantly lower in group 3 (45s cycle with a 3-compartment sleeve) than group 4 (45s cycle with a single compartment sleeve) (p=0.040).
 
Two industry-sponsored RCTs were published in 2012 that included women with breast cancer who had documented post-surgical upper-extremity lymphedema. Fife and colleagues compared treatment with the Flexitouch™ system to the Biocompression Systems Sequential Circulator (Fife, 2012).  Participants needed to have at least 5% edema volume in the upper extremity at the time of study enrollment. A total of 36 women from 3 centers were included, 18 in each group. Participants used the devices for home treatment for 1 hour per day for 12 weeks in addition to standard care e.g. wearing compression garments. The Biocompression Systems device utilized an arm garment only whereas the Flexitouch device utilized three garments and treated the full upper extremity (arm, chest and truncal quadrant). Outcome assessment was conducted by experienced lymphedema therapists; blinding was not reported. Edema outcomes were available for all participants and local tissue water analysis for 28 of 36 (78%) of participants.
 
At the p<0.05 level, there was a statistically significant difference in edema volume and tissue water at 12 weeks between groups, favoring treatment with the Flexitouch system. If the p-value was adjusted for the 2 primary outcome variables (edema volume and local tissue water) or the 4 reported outcome variables, differences would not be statistically different. The study was limited by its small sample size, missing data on the local tissue water outcome and unclear blinding of outcome assessment. Also, the outcomes reported were primarily volume of fluid removed, which is an intermediate outcome. It is unclear whether the difference in volume of fluid removed would translate to clinically meaningful differences in symptoms, functional status, and/or quality of life.
 
Ridner and colleagues conducted an RCT comparing treatment with the Flexitouch™ system of the arm-only versus the arm, chest and trunk in women with breast cancer who had arm lymphedema (Ridner, 2012). To be eligible for participation, there needed to have a 2 cm difference in girth on the affected arm compared to the unaffected arm. A total of 47 patients were enrolled; 5 patients were withdrawn in the course of the study, leaving n=21 in each treatment group. Participants completed training in using the device and were observed in the laboratory to insure they used proper technique; the remainder of the sessions were conducted at home. Patients in the experimental group (arm, chest and trunk treatment) were told to perform 30 daily sessions of 1-hour each; patients in the control group (arm-only) were told to perform 30 daily treatments of 36 minutes each. Final outcome assessment took place at the end of the 30-day treatment period. The authors did not report whether the staff members that assessed objective outcomes were blinded to the patient’s treatment group. There were no statistically significant differences between groups in efficacy outcomes. For example, change in the volume of the affected arm was -2.66 ml in the experimental group and -0.38 ml in the control group, p=0.609. In addition, the mean number of symptoms reported at the end of the study was 10.0 in the experimental group and 6.0 in the control group (p=0.145).
 
Venous ulcers
A 2011 Cochrane review addressed intermittent pneumatic compression pumps for treating venous leg ulcers (Nelson, 2011). The review identified a total of 7 RCTs. Four trials compared pneumatic compression pumps plus compression bandages or stockings to compression bandages or stockings only, 1 trial compared compression pumps to wound dressings only and 1 trial compared two intermittent pneumatic compression regimens. The trial comparing pumps to wound dressings, which was not blinded, found a significantly greater rate of wound healing with compression treatment. However, the more relevant comparison intervention is continuous compression provided by bandages or stockings. The 4 trials with this comparison had sample sizes ranging from 22 to 53. Blinding was unclear in 3 of the studies and the fourth was not blinded. In a pooled analysis of 3 of the 4 trials, there was not a statistically significant difference in the number of healed ulcers in the group receiving intermittent pneumatic compression or compression bandaging or stockings only, risk ratio (RR): 1.09 (95% confidence interval [CI]: 0.91-1.30). The fourth trial found a significantly higher healing rate in the pump group than the compression bandage/stocking group; in this trial, the rate of healing with compression bandages/stockings was particularly low.
 
In 2013, an additional RCT including 70 patients was published by Dolibog and colleagues in Poland (Dolibog, 2013). The study was single-blind; outcome assessment was blinded. All patients had received standard medical treatment (drug therapy and gauze dressings changed once a day) for 2 months prior to study participation. There were a total of 6 treatment groups. Patients were stratified by wound type, superficial venous reflux alone versus superficial plus segmental deep venous reflux. Within each of these groups, patients were randomized to 1 of 3 compression treatments: intermittent pneumatic compression (using a Flowtron device), stockings or compression short-stretch bandages. The primary study outcome, proportion of wounds healed at 15 days, was significantly higher in the intermittent pneumatic compression and stockings groups than in the bandage groups. The proportion of wounds healed did not differ significantly with pneumatic compression versus stockings. For example, among patients with isolated superficial vein insufficiency, the proportion of ulcers healed was 25% in the intermittent compression group, 27% in the stockings group and 10% in the bandages group. Similar results were found for the outcome of percentage reduction in wound area.
 
This evidence is insufficient to conclude whether lymphedema pumps improve healing of venous ulcers. Overall, there are few trials that reported on the most relevant clinical comparisons i.e., pneumatic compression as an adjunct to optimal wound care compared to optimal wound care alone. In many studies, it is difficult to ascertain whether optimal wound care was provided in the control group and whether enrolled patients had failed optimal wound care prior to enrollment in the study. The available studies do not consistently show that intermittent pneumatic compression improves ulcer healing. Moreover, many of the studies have methodological limitations such as a lack of blinding or a failure to report on complete ulcer healing. The literature is characterized by a high degree of heterogeneity among studies in the types of pumps used, the protocols for pneumatic compression, the comparison groups, and control interventions. The pumps used in the trials varied and some were older devices used in the 1980s and 1990s. This creates challenges in classifying the types of devices used. Moreover, it is difficult to compare the pumps in the trials to currently available lymphedema pumps since all but 1 of the studies were published at least 10 years ago and some were from the late 1980s/early 1990s.
 
2016 Update
A literature search conducted through May 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A 2015 RCT from Japan, included 31 women with unilateral upper-extremity lymphedema after mastectomy (Uzkeser, 2015). To be eligible for participation, there needed to be at least 10% increased volume in the affected limb or more than 2 cm difference in circumference between limbs. Patients were randomly assigned to receive decongestive physical therapy alone (n=15) or decongestive physical therapy plus intermittent pneumatic compression (n=16). Pneumatic compression was delivered using a pump marketed in Japan (Mark II Plus) and was applied for 45 minutes after manual lymphatic drainage. Both groups underwent 5 weekly sessions for 3 weeks (a total of 15 sessions). At the immediate posttreatment and 1 month follow-up points, there were no statistically significant differences in groups in any outcomes including arm circumference and dermal thickness of the arm and forearm.   
 
2017 Update
This policy was reviewed. A literature search was conducted using the MEDLINE database to identify any published studies on the use of lymphedema pumps in the treatment of head and neck lymphedema. There was no published literature identified to support the clinical utility of this treatment. The evidence is insufficient to conclude whether lymphedema pumps improve head and neck lymphedema resulting from cancer treatment or any other indications. The coverage statement has been updated to address this indication.
 
2018 Update
A literature search was conducted through July 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
E0650Pneumatic compressor, nonsegmental home model
E0651Pneumatic compressor, segmental home model without calibrated gradient pressure
E0652Pneumatic compressor, segmental home model with calibrated gradient pressure
E0655Nonsegmental pneumatic appliance for use with pneumatic compressor, half arm
E0660Nonsegmental pneumatic appliance for use with pneumatic compressor, full leg
E0665Nonsegmental pneumatic appliance for use with pneumatic compressor, full arm
E0666Nonsegmental pneumatic appliance for use with pneumatic compressor, half leg
E0667Segmental pneumatic appliance for use with pneumatic compressor, full leg
E0668Segmental pneumatic appliance for use with pneumatic compressor, full arm
E0669Segmental pneumatic appliance for use with pneumatic compressor, half leg
E0671Segmental gradient pressure pneumatic appliance, full leg
E0672Segmental gradient pressure pneumatic appliance, full arm
E0673Segmental gradient pressure pneumatic appliance, half leg
E0675Pneumatic compression device, high pressure, rapid inflation/deflation cycle, for arterial insufficiency (unilateral or bilateral system)
E0676Intermittent limb compression device (includes all accessories), not otherwise specified

References: Dolibog P, Franek A, Taradaj J et al.(2013) 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.

Gurdal SO, Kostanoglu A, Cavdar I et al.(2012) Comparison of intermittent pneumatic compression with manual lymphatic drainage for treatment of breast cancer-related lymphedema. Lymphat Res Biol 2012; 10(3):129-35.

Harris SR, Hugi MR, Olivotto IA et al.(2001) Clinical practice guidelines for the care and treatment of breast cancer: 11. . Lymphedema. CMAJ 2001; 164(2):191-9.

Johansson K, Lie E, Ekdahl C et al.(1998) A randomized study comparing manual lymph drainage with sequential pneumatic compression for treatment of postoperative arm lymphedema. Lymphology 1998; 31(2):56-64.

Lee B, Andrade M, Antignani PL, et al.(2013) Daignosis and Treatment of Primary Lymphedema. Consensus Document of the Iinternational Union of Phlebology (IUP)-2013. Int Angiol. 2013 December; 32(6): 541-74. 2013.

Mayrovitz HN, Brown-Cross D, Mayrovitz BL et al.(2009) Role of truncal clearance as a therapy component. Home Health Care Manag Pract 2009; 21(5):325-37.

Nelson EA, Mani R, Thomas K et al.(2011) Intermittent pneumatic compression for treating venous leg ulcers. Cochrane Database Syst Rev 2011; (2):CD001899.

O'Donnell TF, Jr., Passman MA, Marston WA, et al.(2014) Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery (R) and the American Venous Forum. J Vasc Surg. Aug 2014;60(2 Suppl):3s-59s. PMID 24974070

Oremus M, Dayes I, Walker K et al.(2012) Systematic review: conservative treatments for secondary lymphedema. BMC Cancer 2012; 12:6.

Oremus M, Walker K, Dayes I et al.(2009) Diagnosis and treatment of secondary lymphedema. Technology Assessment Report. Project ID: LYMT0908. October 19, 2009. McMaster University Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality.

Oremus M, Walker K, Dayes I.(2010) 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). Available online at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id66aTA.pdf. Last accessed July, 2012.

Pilch U, Wozniewski M, Szuba A.(2009) Influence of compression cycle time and number of sleeve chambers on upper extremity lymphdema volume reduction during intermittent pneumatic compression. Lymphology 2009; 42(1):26-35.

Pilch U, Wozniewski M, Szuba A.(2009) Influence of compression cycle time and number of sleeve chambers on upper extremity lymphedema volume reduction during intermittent pneumatic compression. Lymphology 2009; 42(1):26-35.

Szuba A, Achalu R, Rockson SG.(2002) Decongestive lymphatic therapy for patients with breast carcinoma-associated lymphedema. Cancer 2002; 95(11):2260-7.

Uzkeser H, Karatay S, Erdemci B, et al.(2015) 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. PMID 23925581

Wilburn O, Wilburn P, Rockson SG.(2006) A pilot, prospective evaluation of a novel alternative for maintenance therapy of breast cancer-associated lymphedema. BMC Cancer 2006; 6:84.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2019 American Medical Association.