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MP 1.01.18 Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers

Medical Policy    
Section
Durable Medical Equipment 
Original Policy Date
7/10/98

Last Review Status/Date
Reviewed with literature search/10:2013

Issue
10:2013
  Return to Medical Policy Index


Disclaimer 

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically. 


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 chamber (nonsegmented) or multichamber (segmented) and have varying design and complexity.

Background

Lymphedema is an abnormal accumulation of lymph fluid in subcutaneous tissues or body cavities resulting from 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, postradiation 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.

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.

Pneumatic compression 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:

Single-chamber nonprogrammable pumps: These are the simplest pumps, consisting of a single chamber that is inflated at one time that applies uniform pressure.

Multichamber nonprogrammable 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 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 multichamber 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. In some situations, including in patients with scarring, contractures, or highly sensitive skin, programmable pumps are generally considered to be the preferred option.

Pneumatic compression pumps may be used in lymphedema clinics or purchased or rented for home use; this policy addresses the home use of these 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™ (ThermoTek, Inc.), CTU676(R) (Compression Technologies), and Recovery+™ (Pulsar Scientific)


Policy

Single compartment or multichamber nonprogrammable lymphedema pumps applied to the limb may be considered medically necessary 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 multichamber programmable lymphedema pumps applied to the limb may be considered medically necessary for the treatment of lymphedema when:

  1. The individual is otherwise eligible for nonprogrammable pumps; and
  2. 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).

Single compartment or multichamber lymphedema pumps applied to the limb are considered investigational in all situations other than those specified above in the first two policy statements.

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.

The use of pneumatic compression pumps to treat venous ulcers is considered investigational.


Policy Guidelines

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

Multichamber 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:

E0656: Segmental pneumatic appliance for use with pneumatic compressor, trunk

E0657: Segmental pneumatic appliance for use with pneumatic compressor, chest

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

Multichamber 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 


Benefit Application
BlueCard/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all FDA-approved devices may not be considered investigational and, thus, these devices may be assessed only on the basis of their medical necessity.

Compliance may be an issue with lymphedema pumps, due either to lack of effectiveness or patient dissatisfaction with the pumping process itself. Therefore, plans may consider requiring that a pump be initially rented for a period of 1 to 2 months prior to purchase to confirm compliance.


Rationale

The policy was created in 1998 and was based on a TEC Assessment which concluded that concluded that pneumatic compression devices are efficacious to some degree but that it was not possible to estimate precisely the magnitude of this effect. (1) Beginning in 2010, the policy was updated regularly with searches of the MEDLINE database. The most recent literature search was for the period August 2012 through August 16, 2013. Following is a summary of the key literature to date:

Lymphedema

The literature review addresses two main questions: the efficacy and safety of pneumatic compression pumps compared to alternative treatments for lymphedema and the relative efficacy of different types of pumps. Due to the FDA-approval of lymphedema pumps that treat the truncal area in addition to the affected limb, there has recently been interest in the evidence on truncal clearance as part of lymphedema treatment. The updated literature searches did not identify any comparative studies that examined whether treating the truncal area in addition to the affected limb improves the outcomes of pneumatic compression pump treatment more than only treating the limb.

In 2010, 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. (2) The authors, Oremus and colleagues, identified a total of 10 studies; 6 moderate-to-high-quality randomized controlled trials (RCTs), 2 low-quality 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. 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 studies 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. 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 any type of intermittent pneumatic compression (IPC) device and sleeve was more effective than another type.

In 2012, Oremus and colleagues published an updated systematic review on conservative treatments for secondary lymphedema. (3) 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 (4)) found that a 3-chamber IPC sleeve was superior to a 1-chamber sleeve for reducing edema.

Representative RCTs are described below:

Lymphedema pumps compared to alternative treatment

In 2002, Szuba and colleagues published an article that evaluated the Biocompression Systems Sequential Circulator lymphedema pump, a 4-chamber device, in 2 RCTs conducted in the U.S. among women with breast cancer. (5)

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 nonpump group (26%), p<0.05. The difference in volume reduction between groups was not significantly different at 40 days at the end of Phase II; there was a mean reduction of 30% in the pump group and 27% in the nonpump 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 1 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, the authors reported that only 1 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. (6) 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 patients used only a compression garment. The difference in arm volume was significantly greater after treatment with the Flexitouch™ (mean decrease of 207 mL) than after self-massage (mean increase of 52 mL), p=0.007.

A small RCT from Turkey, published in 2012, studied women with breast cancer-related lymphedema. (7) The authors did not specify the IPC device that was used. The trial measured manual lymphatic drainage in combination with compression bandages (n=15) or in combination with pneumatic compression (n=15). Total arm volume decreased by a mean of 529 mL (14.9%) in the compression bandage group and 439 mL (12.2%) in the IPC group; the difference between groups was not statistically significant. Findings were similar on other outcomes.

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. (4) 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 posttreatment 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 postsurgical upper-extremity lymphedema. Fife and colleagues compared treatment with the Flexitouch™ system to the Biocompression Systems Sequential Circulator. (8) 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 3 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.

Key outcomes at the end of the 12-week treatment period are as follows:

 

Flexitouch

Sequential Circulator

p-value

Affected arm volume (ml)

2,952 ± 724

3,013 ± 773

0.141

Edema volume (ml)

438 ± 344

537 ± 293

0.050

Edema volume (%)

18.2 ± 14.0

21.0 ± 10.7

0.047

Local tissue water (TDC*)

33.8 ± 7.6

33.5 ± 6.6

0.049

*TDC: arm tissue dielectric constant

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. (8) 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. (10) 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 2 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. (11) 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.

The 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. 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 2 of the studies were published at least 10 years ago and some were from the late 1980s/early 1990s. The most recent study, published in 2013, did not find a significant difference in the wound healing rate with intermittent pneumatic compression compared to compression stockings, although outcomes were better with both of these interventions than with compression bandages.

Ongoing Clinical Trials

Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema (ACE) (NCT01239160) (12): This multicenter single-blind randomized trial will compare the efficacy of two types of lymphedema pumps in 262 patients with lower limb lymphedema. Patients are randomized to use a pump without calibrated compression (Hydroven PFR) or a pump with calibrated compression (Flexitouch System). The primary endpoint is limb volume reduction after 12 weeks of treatment, with the outcome at 24 weeks included as a secondary endpoint. The trial is sponsored by the Centre for Research and Implementation of Clinical Practice in the U.K. and Tactile Technologies. The expected date of completion is December 2013.

Summary

The available evidence from randomized controlled trials suggests that use of pneumatic compression pumps may be effective at reducing limb volume in patients with lymphedema who fail to respond to conservative therapy. There is insufficient evidence from comparative trials that one type of pump is more effective than another for lymphedema patients. Therefore, nonprogrammable lymphedema pumps are considered medically necessary, and programmable pumps are considered medically necessary only for patients unable to use the standard pumps. There is insufficient evidence that treating the truncal area in addition to the limb affected by lymphedema improves the outcomes of pneumatic compression pump treatment more than only treating the limb. Therefore, 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.

There is insufficient evidence that pneumatic compression pumps enhance healing of venous ulcers compared to standard compression techniques e.g., bandaging. There are few RCTs on this topic and a meta-analysis of RCTs did not find a significant benefit of pneumatic compression pumps for ulcer healing. Thus, use of lymphedema pumps for the treatment of venous ulcers is considered investigational.

Practice Guidelines and Position Statements

A 2009 consensus statement from the International Union of Phlebology stated that sequential pneumatic compression is an effective treatment for primary lymphedema and is particularly useful in situations in which lymphedema is best treated by physical passive therapy e.g., elderly and disabled patients. (13)

A 2009 technology assessment report by the McMaster University Evidence-based Practice Center for AHRQ had the following conclusions regarding treatment of secondary lymphedema (3): “…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.

Medicare National Coverage

A 2002 National Coverage Determination for Pneumatic Compression Devices (280.6) states the following (14):

A - Lymphedema

…Pneumatic compression devices are covered in the home setting for the treatment of lymphedema if the patient has undergone a four-week trial of conservative therapy and the treating physician determines that there has been no significant improvement or if significant symptoms remain after the trial. The trial of conservative therapy must include use of an appropriate compression bandage system or compression garment, exercise, and elevation of the limb. The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression.

B - 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.

Pneumatic compression devices are covered in the home setting for the treatment of CVI of the lower extremities only if the patient has one or more venous stasis ulcer(s) which have failed to heal after a 6 month trial of conservative therapy directed by the treating physician. The trial of conservative therapy must include a compression bandage system or compression garment, appropriate dressings for the wound, exercise, and elevation of the limb.

References:
 
 
  1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Special Report: Comparative Efficacy of Different Types of Pneumatic Compression Pumps for the Treatment of Lymphedema. TEC Assessments 1998; Volume 13, Tab 2.
  2. 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. Available online at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id66aTA.pdf. Last accessed September, 2013.
  3. Oremus M, Dayes I, Walker K et al. Systematic review: conservative treatments for secondary lymphedema. BMC Cancer 2012; 12:6.
  4. Pilch U, Wozniewski M, Szuba A. 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.
  5. Szuba A, Achalu R, Rockson SG. Decongestive lymphatic therapy for patients with breast carcinoma-associated lymphedema. A randomized, prospective study of a role for adjunctive intermittent pneumatic compression. Cancer 2002; 95(11):2260-7.
  6. Wilburn O, Wilburn P, Rockson SG. A pilot, prospective evaluation of a novel alternative for maintenance therapy of breast cancer-associated lymphedema [ISRCTN76522412]. BMC Cancer 2006; 6:84.
  7. Gurdal SO, Kostanoglu A, Cavdar I et al. Comparison of intermittent pneumatic compression with manual lymphatic drainage for treatment of breast cancer-related lymphedema. Lymphat Res Biol 2012; 10(3):129-35.
  8. Fife CE, Davey S, Maus EA et al. A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home. Support Care Cancer 2012; 20(12):3279-86.
  9. Ridner SH, Murphy B, Deng J et al. A randomized clinical trial comparing advanced pneumatic truncal, chest, and arm treatment to arm treatment only in self-care of arm lymphedema. Breast Cancer Res Treat 2012; 131(1):147-58.
  10. Nelson EA, Mani R, Thomas K et al. Intermittent pneumatic compression for treating venous leg ulcers. Cochrane Database Syst Rev 2011; (2):CD001899.
  11. 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.
  12. Sponsored by the Centre for Research & Implementation of Clinical Practice (U.K.). Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema (ACE) (NCT01239160). Available online at: www.clinicaltrials.gov. Last accessed September, 2013.
  13. Lee B, Andrade M, Bergan J et al. Diagnosis and treatment of primary lymphedema. Consensus document of the International Union of Phlebology (IUP)-2009. Int Angiol 2010; 29(5):454-70.
  14. Centers for Medicare and Medicaid Services. National Coverage Determination (NCD) for Pneumatic Compression Devices (280.6) Available online at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=225&ncdver=1&NCAId=50&NcaName=Lymphedema+Pumps&CoverageSelection=National&KeyWord=lymphedema+pumps&KeyWordLookUp=Title&KeyWordSearchType=And&clickon=search&bc=gAAAABAAEAAA&. Last accessed September, 2013. 
  
  

Codes

Number

Description

CPT  No code 
ICD-9 Procedure  No code 
ICD-9 Diagnosis  457.0  Postmastectomy lymphedema syndrome 
  457.1  Other lymphedema (includes acquired and secondary lymphedema) 
  757.00  Hereditary edema of legs (includes congenital lymphedema) 
  997.99  Other complications affecting specified body systems, not elsewhere classified (includes lymphedema resulting from surgical or medical care) 
HCPCS  E0650, E0651, E0652, E0655, E0656, E0657, E0660, E0665, E0666, E0667, E0668, E0669, E0671, E0672, E0673, E0675, E0676 Pneumatic compressor code range (See policy guidelines, above)
ICD-10-CM (effective 10/1/14) I89.0 Lymphedema, not elsewhere classified
I97.2 Postmastectomy lymphedema syndrome
   Q82.0 Hereditary lymphedema
ICD-10-PCS (effective 10/1/14)    Not applicable. This policy applies to equipment only. There are no applicable procedure codes.
Type of Service  Durable Medical Equipment 
Place of Service  Home 

Index

Lymphedema pumps
Pneumatic compression pumps


Policy History  

Date Action Reason
7/10/98 Add to Durable Medicine section New Policy
7/12/02 Replace Policy Policy reviewed without literature review; new review date only.
04/29/03 Replace Policy Policy reviewed without literature review; new review date only.
07/08/10 Replace policy -local policy (excepting for truncal edema added to investigational statement) Policy returned to active review. Policy updated with literature search through May 2010; references 2-8 added. Title changed to Pneumatic Compression Pumps for Lymphedema. “Non-programmable” added to first policy statement and “elastic garments” changed to “compression garments”. Programmable pumps changed to medically necessary if criteria met; new policy statement added that two-phase multi-chamber pumps are investigational.
08/12/10 Replace policy - no longer local policy Policy reviewed with literature review on pneumatic compression pumps for treating truncal areas. No change to policy statements. Reference 2 added.
8/11/11 Replace policy Policy reviewed with literature search. Brand name removed from policy statement on 2-phase pumps. Statement added that pumps investigational in all situations other than those specified in medically necessary statements. References 3 and 7 added; other references renumbered or removed.
10/11/12 Replace policy Policy reviewed with literature search through August 2012. Title changed to Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers. Statement on two-phase pumps deleted. Statement added that 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. The use of lymphedema pumps to treat venous ulcers is considered investigational. References 1, 4, 8-10 and 13 added; other references renumbered or removed.
10/10/13 Replace policy Policy reviewed with literature search through August 16, 2013. “Applied to the limb” added to the first 3 policy statements for clarification. In the statement on venous ulcers, “lymphedema pumps” changed to “pneumatic compression pumps”. References 7 and 11 added; other references renumbered or removed