|MP 1.01.18||Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers|
Durable Medical Equipment
|Original Policy Date
Last Review Status/Date
|Return to Medical Policy Index|
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.
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 compression garments, drugs, bandaging, manual lymphatic drainage and pneumatic compression devices (ie, lymphedema pumps). Comprehensive decongestive therapy combines manual drainage, bandaging, exercises and skin care, and may also include compression garments, dietary recommendations and/or breathing exercises. Rarely, surgery is used as a treatment option.
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.
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) FDA product code: JOW
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:
- The individual is otherwise eligible for nonprogrammable pumps; and
- There is documentation that the individual has unique characteristics that prevent satisfactory pneumatic compression with single-compartment or multichamber nonprogrammable lymphedema pumps (e.g., significant scarring).
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.
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.
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
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
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.
The policy was created in 1998 and was based on a TEC Assessment which 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. Most recently, the literature was reviewed through July 25, 2014. Following is a summary of the key literature to date.
In 2010, the McMaster University Evidence-based Practice Center, under contract with the Agency for Healthcare Research and Quality, published a technology assessment on diagnosis and treatment of secondary lymphedema that included discussion of intermittent pneumatic compression (IPC) pumps.(2) The authors, Oremus et al, 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 with 6 different alternative interventions (including compression bandages, laser, 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) with 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.
In 2012, Oremus et al 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. According to the review article, 2 RCTs found 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. The sixth RCT compared 2 types of pumps and is discussed in a later section.
A 2014 systematic review by Shao et al addressed pneumatic compression pumps for treatment of breast cancer-related lymphedema.(4) The authors identified 7 RCTs; most compared decongestive lymphatic therapy alone with decongestive lymphatic therapy plus lymphedema pump therapy. A pooled analysis of data from the 3 RCTs suitable for meta-analysis did not find a statistically significant difference in the percent of volume reduction with and without use of lymphedema pumps (mean difference, 4.51; 95% confidence interval [CI], -7.01 to 16.03). Data from the other 4 trials were not included in the meta-analysis.
Representative RCTs are described next.
In 2002, Szuba et al published an article that evaluated the Biocompression Systems Sequential Circulator lymphedema pump, a 4-chamber device, in 2 RCTs conducted in the United States among women with breast cancer.(5) In their first RCT, the investigators evaluated initial treatment of women with unilateral lymphedema (an increase of at least 20% in the volume of the swollen arm compared with 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 to 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 with the nonpump group (26%) (p<0.05). The difference in volume reduction between groups was not significantly different at 40 days; there was a mean reduction of 30% in the pump group and 27% in the nonpump group.
The second Szuba study included women who had received a course of decongestive lymphatic therapy at least 1 month and less than 1 year before 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 (ie, lymphatic massage and use of a compression garment) was compared with 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 thesnumber 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,sduring the month of self-administered conservative treatment alone, there was a mean increase in volumesof 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 insblood pressure during pump use.
In 2006, Wilburn et al 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, 207 mL) than after self-massage (mean increase, 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.
Relative Efficacy of Different Lymphedema Pump Types and/or Protocols
Due to 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.
A 2009 RCT by Pilch et al, in Poland, compared lymphedema pumps in terms of number of chambers and cycle times.(8) Fifty-seven women with lymphedema of the arm following breast cancer treatment were randomly assigned to 1 of 4 treatments: (1) 1-to-1 cycle of compression and interval (90s: 90s) with a single chamber sleeve (n=17); (2) 1-to-1 cycle of compression and interval (90s: 90s) with a 3-chamber sleeve (n=9); (3) 3-to-1 cycle of compression and interval (45s: 15s) with a single chamber sleeve (n=11); or (4) 3-to-1 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 postsurgical upper-extremity lymphedema. Fife et al compared treatment with the Flexitouch™ system with the Biocompression Systems Sequential Circulator.9 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, eg, wearing compression garments. The Biocompression Systems device used an arm garment only, whereas the Flexitouch device used 3 garments and treated the full upper extremity (arm, chest, 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.
The authors reported 4 key outcomes at 12 weeks. There were statistically significant between-group differences in 2 of these, edema volume reported as a percent (p=0.047) and tissue water (p=0.49); both favoring treatment with the Flexitouch system. Groups did not differ significantly on the other 2 outcomes, affected arm volume at 12 weeks (p=0.141) or for edema volume reported in milliliters (p=0.50). Moreover, if the p value had been adjusted for multiple comparisons (ie, the 4 reported outcome variables), none of the variables would have been 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 et al 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.10 To be eligible for participation, there needed to be a 2-cm difference in girth on the affected arm compared with the unaffected arm. A total of 47 patients were enrolled; 5 patients were withdrawn in the course of the study, leaving 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 was conducted at home. Patients in the experimental group (arm, chest 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).
A Cochrane review by Nelson et al, updated in 2014, addressed intermittent pneumatic compression pumps for treating venous leg ulcers.(11) The review identified a total of 9 RCTs. Five trials compared pneumatic compression pumps plus continuous compression with continuous compression alone, 2 trials compared compression pumps with continuous compression (stockings or bandages), 1 trial compared compression pumps with wound dressings only, and 1 trial compared 2 intermittent pneumatic compression regimens. In a meta-analysis of 3 of the 5 trials evaluating the incremental benefit of pneumatic compression pumps over continuous compression alone, there was a significantly higher rate of healing with combined treatment (risk ratio, 1.31; 95% CI, 1.06 to 1.63). Two of these 3 trials were considered to have a high risk of bias, eg, not blinded and had unclear allocation concealment. There was a high degree of heterogeneity among trials, and findings from other RCTs were not pooled. Neither of the 2 trials comparing intermittent pneumatic compression with continuous compression with stockings or bandages found statistically significant between-group differences in healing rates.
A 2014 RCT by Dolibog et al was published after the Cochrane review literature search.(12) The study included 147 patients with venous ulcers. It compared 5 types of compression therapy: intermittent pneumatic compression using a 12-chamber Flowtron device, stockings, multilayer bandages, 2-layer bandages, and Unna boots. All patients received standard drug therapy and the compression interventions lasted 2 months. The rate of complete healing at the end of treatment was similar in 3 of the treatment groups: 16 of 28 patients (57%) in the pneumatic compression group, 17 of 30 (57%) in the stockings group, and 17 of 29 (59%) in the multilayer bandage group. On the other hand, rates of healing were much lower in the other 2 groups; 5 of 30 (17%) in the two-layer bandage group and 6 of 30 (20%) in the Unna boot group. A 2013 pilot study by Dolibog et al, included in the Cochrane review, had similar findings.(13)
Ongoing and Unpublished Clinical Trials
Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema (ACE) (NCT01239160)14: This multicenter, single-blind, randomized trial will compare the efficacy of 2 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 end point is limb volume reduction after 12 weeks of treatment, with the outcome at 24 weeks included as a secondary end point. 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 2014.
Summary of Evidence
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 1 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 on whether intermittent pneumatic compression pumps improve healing of venous ulcers. The available studies have methodologic limitations such as lack of blinding and inadequate randomization. Moreover, 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. 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, eg, elderly and disabled patients.(15)
A 2009 technology assessment report by the McMaster University Evidence-based Practice Center for the Agency for Healthcare Research and Quality had the following conclusions regarding treatment of secondary lymphedema3: “…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.
U.S. Preventive Services Task Force Recommendations
The use of pneumatic compression pumps is not a preventive service.
Medicare National Coverage
A 2002 National Coverage Determination for Pneumatic Compression Devices (280.6) stated the following(16):
…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:
- 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.
- 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.
- Oremus M, Dayes I, Walker K et al. Systematic review: conservative treatments for secondary lymphedema. BMC Cancer 2012; 12:6.
Shao Y, Qi K, Zhou QH, et al. Intermittent pneumatic compression pump for breast cancer-related lymphedema: a systematic review and meta-analysis of randomized controlled trials. Oncol Res Treat. 2014;37(4):170-174. PMID 24732640
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. Dec 1 2002;95(11):2260-2267. PMID 12436430
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. PMID 16571129
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. Sep 2012;10(3):129- 135. PMID 22984910
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. Mar 2009;42(1):26-35. PMID 19499765
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. May 2 2012;20(12):3279-3286. PMID 22549506
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. Jan 2012;131(1):147-158. PMID 21960113
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
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. Aug 2013;59(8):22-30. PMID 23934375
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): www.clinicaltrials.gov. Accessed July, 2014.
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. Oct 2010;29(5):454-470. PMID 20924350
Centers for Medicare and Medicaid Services. National Coverage Determination (NCD) for Pneumatic Compression Devices (280.6) http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=225&ncdver=1&NCAId=50&NcaName=Lymphedema+Pumps&CoverageSelection=Nationa l&KeyWord=lymphedema+pumps&KeyWordLookUp=Title&KeyWordSearchType=And&clickon=search&bc=gAA AABAAEAAA. Accessed July, 2014.
|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 10/1/15)||I89.0||Lymphedema, not elsewhere classified|
|I97.2||Postmastectomy lymphedema syndrome|
|ICD-10-PCS (effective 10/1/15)||Not applicable. This policy applies to equipment only. There are no applicable procedure codes.|
|Type of Service||Durable Medical Equipment|
|Place of Service||Home|
Pneumatic compression pumps
|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|
|9/11/14||Replace policy||Policy reviewed with literature review through July 25, 2014. No change to policy statements. References 4 and 11-13 added.|