Medical policy: Compression Devices for Treatment of Lymphedema and Peripheral Vascular Disease

Policy number: MP 6.013

Effective date: 2/1/2026

Policy

Single-compartment or multichamber nonprogrammable pneumatic compression pumps applied to the limbs 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 pneumatic compression pumps applied to the limbs 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 (e.g., significant scarring) that prevent satisfactory pneumatic compression with single-compartment or multichamber nonprogrammable compression pumps; or
3. The individual has had an inadequate response to an initial course of treatment with a nonprogrammable pneumatic compression pump applied to the limbs (see Policy Guidelines).

Single-compartment or multichamber nonprogrammable pneumatic compression pumps applied to the chest or trunk in addition to the limbs may be considered medically necessary for the treatment of lymphedema that has failed to adequately respond to both conservative measures and nonprogrammable pneumatic compression to the limbs only.

Single-compartment or multichamber programmable pneumatic compression pumps applied to the chest or trunk in addition to the limbs may be considered medically necessary for the treatment of lymphedema when:

1. The individual is otherwise eligible for nonprogrammable pneumatic compression pumps applied to the chest or trunk in addition to the limbs; and
2. There is documentation that the individual has unique characteristics (e.g., significant scarring, recent surgery) that prevent satisfactory pneumatic compression with single-compartment or multichamber nonprogrammable compression pumps; or
3. The individual has had an inadequate response to an initial course of treatment with nonprogrammable pneumatic compression pump applied to the chest or trunk in addition to the limbs (see Policy Guidelines).

Single-compartment or multichamber compression pumps are considered investigational in all other situations other than those specified above, including when applied to the head or neck.

Programmable, wearable non-pneumatic compression pumps (e.g., Koya Dayspring) applied to the limbs may be considered medically necessary for the treatment of lymphedema when:

1. The individual is otherwise eligible for a programmable pneumatic compression pump; and
2. There is documentation that the individual has lifestyle considerations or mobility requirements where treatment compliance with a traditional programmable pneumatic compression system is expected to be insufficient.

Programmable, wearable non-pneumatic compression pumps are considered investigational in all other situations not specified above.

The use of pneumatic or non-pneumatic compression pumps to treat venous ulcers or peripheral arterial occlusive disease / arterial insufficiency are considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Note: Lymphedema pumps for use following a mastectomy is a mandated benefit according to Pennsylvania Act 51 of 1997.

Policy guidelines

Medically necessary positions for treatment of lymphedema at body sites other than the limbs are based on clinical input. Individuals who fail to respond to an initial trial of a nonprogrammable pump may benefit from programmable pumps with pulsatile features that can be tailored to address individual lymphatic flow dysfunction patterns. Clinical input supports the use of non-pneumatic compression pumps on the basis of the evidence and clinical experience, emphasizing the importance of compliance with treatment. Clinical input was mixed on the use of compression pumps for the treatment of head and neck lymphedema. Ongoing evidence generation in head and neck cancer populations is expected to elucidate clinical benefit.

Cross-references:

• MP 2.190 Bioimpedance Devices for Detection and Management of Lymphedema
• MP 6.053 Postsurgical Home Use of Limb Compression Devices for Venous Thromboembolism Prophylaxis
• MP 8.001 Physical Medicine and Specialized Physical Medicine Treatments (Outpatient)

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to FEP Medical Policy Manual.

Description/Background

Lymphedema

Lymphedema is an accumulation of fluid due to disruption of lymphatic drainage. It is characterized by nonpitting swelling of an extremity or trunk, and is associated with wound healing impairment, recurrent skin infections, pain, and decreased quality of life. Lymphedema can be caused by congenital or inherited abnormalities in the lymphatic system (primary lymphedema) but is most often caused by acquired damage to the lymphatic system (secondary lymphedema). Breast cancer treatment (surgical removal of lymph nodes and radiotherapy) is one of the most common causes of secondary lymphedema. In a systematic review of 72 studies (N=29,612 women), DiSipio et al. reported that nearly 20% of breast cancer survivors will develop lymphedema. The risk factors with robust evidence for the development of lymphedema included extensive surgical procedures (such as axillary lymph node dissection, a higher number of lymph nodes removed, and mastectomy) as well as being overweight or obese.

Diagnosis and staging

A diagnosis of secondary lymphedema is based on history (e.g., cancer treatment, trauma) and physical examination (localized, progressive edema and asymmetric limb measurements) when other causes of edema can be excluded. Imaging, such as MRI, computed tomography, ultrasound, or lymphoscintigraphy, may be used to differentiate lymphedema from other causes of edema in diagnostically challenging cases.

Table 1 lists International Society of Lymphology guidance for staging lymphedema (2023) based on “softness” or “firmness” of the limb and the changes with an elevation of the limb.

Table 1. Recommendations for staging lymphedema

Management and treatment

Lymphedema is treated using elevation, compression, and exercise. Conservative therapy may consist of several features depending on the severity of the lymphedema. Individuals are educated on the importance of self-care including hygiene practices to prevent infection, maintaining ideal body weight through diet and exercise, and limb elevation. Compression therapy consists of repeatedly applying padding and bandages or compression garments. Manual lymphatic drainage is a light pressure massage performed by trained physical therapists or by affected individuals designed to move fluid from obstructed areas into functioning lymph vessels and lymph nodes. Complete decongestive therapy is a multiphase treatment program involving all of the previously mentioned conservative treatment components at different intensities. Pneumatic compression pumps may also be considered as an adjunct to conservative therapy or as an alternative to self-manual lymphatic drainage in individuals who have difficulty performing self-manual lymphatic drainage. In individuals with more advanced lymphedema after fat deposition and tissue fibrosis has occurred, palliative surgery using reductive techniques such as liposuction may be performed.

Venous ulcers

Manual lymphatic drainage is a light pressure massage performed by trained physical therapists or by affected individuals designed to move fluid from obstructed areas into functioning lymph vessels and lymph nodes. Complete decongestive therapy is a multiphasic treatment program involving all of the previously mentioned conservative treatment components at different intensities.

Compression Pumps

Pneumatic compression pumps (PCPs) may be used in lymphedema or wound care clinics, purchased, or rented for home use; home use is addressed herein. PCPs consist of pneumatic cuffs connected to a pump. These pumps 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 PCPs are available, with varying materials, designs, degrees of pressure, and complexity. There are 3 primary types of pumps. Single chamber nonprogrammable pumps are the simplest pumps, consisting of a single chamber that is inflated at 1 time to apply uniform pressure. Multichamber nonprogrammable 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 adjust the pressure manually in individual compartments. Single- or multi-chamber programmable pumps are similar to the pumps described above except that it is possible to adjust the pressure manually in the individual compartments and/or the length and frequency of the inflation cycles. In some situations, including patients with scarring, contractures, or highly sensitive skin, programmable pumps are generally considered the preferred option. PCPs are also proposed to supplement standard care for patients with venous ulcers. Recently, non-pneumatic, wearable compression pumps have become available. These garments can be programmed to provide graduated sequential compression therapy while providing patients with a functional range of motion and mobility.

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 intended for home or clinic/hospital use include the Compression Pump, Model GS-128 (MedMark Technologies); the Sequential Circulator® (Bio Compression Systems); the Lympha Press® and Lympha-Press Optimal (Mego Afek); the Flexitouch® and Flexitouch Plus systems (Tactile Medical, formerly Tactile Systems Technology); the Powerpress Unit Sequential Circulator (Neomedic); and the EzLymph and EzLymph M (EEZCare Medical).

Several pneumatic compression devices have been cleared by FDA for treatment of venous stasis ulcers. Examples include the Model GS-128, Lympha-Press, Flexitouch®, Flexitouch Plus, and Powerpress Unit (listed above) as well as NanoTherm™ (ThermoTek), CTU676 devices (Compression Technologies), and Recovery+™ (Pulsar Scientific).

In 2024, the FDA cleared the Dayspring (Koya Medical, Inc.) non-pneumatic, wearable limb compression system. The device is intended for use in a clinic or home setting by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of various conditions, including lymphedema and venous insufficiency.

FDA product code: JOW.

Rationale

Summary of evidence

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to limb only, the evidence includes randomized controlled trials (RCTs) and systematic reviews primarily focusing on upper-limb lymphedema secondary to breast cancer. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Most of these RCTs were deemed moderate-to-high quality by the Agency for Healthcare Research and Quality, and about half reported significant improvements with the use of pumps compared to conservative care. Recent meta-analyses indicate that incorporating intermittent pneumatic compression (IPC) with complete decongestive therapy can further enhance lymphedema management within four weeks post-treatment. Similar findings are observed when IPC is combined with decongestive lymphatic therapy compared to decongestive lymphatic therapy alone in managing upper limb lymphedema after breast cancer surgery, with the former combined regimen showing improved external rotation joint mobility. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to limb and chest and/or trunk, the evidence includes two RCTs of the Flexitouch system (Tactile Medical), published in 2012, comparing treatment with and without truncal involvement. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. In one RCT, two (of 4) key outcomes were significantly better with truncal involvement than without. This trial was limited by small sample size, failure to adjust statistically for multiple primary outcomes, and use of intermediate outcomes (e.g., amount of fluid removed) rather than health outcomes (e.g., functional status, quality of life). The second RCT did not find statistically significant differences between groups for any of the efficacy outcomes. The available evidence does not demonstrate that pumps treating the trunk or chest provide incremental improvement beyond that provided by pumps treating the affected limb only. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have lymphedema who failed to respond to conservative therapy who receive pneumatic compression pumps applied to the head and neck, the evidence includes one RCT and a systematic review to assess the use of pneumatic compression treatment for head and neck lymphedema. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. The RCT, comparing treatment with a pneumatic compression pump along with lymphedema self-management compared to self-management alone, examined the feasibility, adherence, and safety of the Flexitouch advanced pneumatic compression device (APCD) by Tactile Medical. The findings showed some improvements in patient-reported outcomes and swelling, although adherence was low, with only one patient using the device twice daily as prescribed. The systematic review also suggested benefits from using the APCD, and it was considered safe and feasible according to the observational studies that reported adverse events. Most studies included participants who had completed or were concurrently undergoing complete decongestive therapy. Out of the 5 observational studies included in the systematic review, four (80%) had potential conflicts of interest related to the funding source. The only study not sponsored by the industry highlighted difficulties in obtaining the APCD, with fewer than half of the patients receiving the device as prescribed. Further research with larger sample sizes and comparisons against the criterion standard of complete decongestive therapy is necessary to establish the efficacy of this treatment approach. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have lymphedema who failed to respond to conservative therapy who receive non-pneumatic compression pumps applied to limb only, the evidence includes randomized crossover trials. Relevant outcomes are symptoms, change in disease status, functional outcomes, and quality of life. Randomized crossover trials have compared use of non-pneumatic, wearable, compression devices to traditional, pneumatic compression devices in both upper and lower extremity lymphedema. These studies have consistently supported noninferior reductions in limb edema volume, higher rates of patient compliance, and improvements on quality of life assessments with use in the short-term (28 to 90 days). Additionally, clinical input supports the use of non-pneumatic, wearable compression devices on the basis of this research and clinical experience. These devices may be particularly suitable for individuals who have an active lifestyle or mobility requirements where traditional pneumatic compression devices are expected to impede sufficient compliance with treatment. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have venous ulcers who receive pneumatic or non-pneumatic compression pumps, the evidence includes RCTs and one systematic review. Relevant outcomes are symptoms, change in disease status, morbid events, and quality of life. A meta-analysis of 3 trials found significantly higher healing rates with lymphedema pumps plus continuous compression than with continuous compression alone; however, 2 of the 3 trials were judged to be at high risk of bias. A 2020 RCT compared lymphedema pumps with continuous compression did not find significant between-group differences in healing rates or durability of pain relief. No prospective, comparative studies assessing the use of non-pneumatic compression devices for the treatment of venous ulcers were identified. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional information

2025 Input

Clinical input was sought to help determine whether the use of pneumatic compression pumps for individuals with lymphedema would provide a clinically meaningful improvement in net health outcome and represents generally accepted medical practice in selected patients. In response to requests, clinical input was received from 3 respondents identified by the National Commission on Lymphatic Diseases (NCLD) or an academic medical center. In addition to this request, a plastic surgeon specializing in lymphedema research and reconstruction at a major academic medical center was interviewed.

For individuals with lymphedema who failed to respond to conservative therapy, clinical input supports that use of pneumatic compression pumps applied to the chest and/or trunk in addition to the limbs is consistent with generally accepted medical practice and its use is expected to provide a clinically meaningful improvement in the net health outcome in individuals who do not respond to limb compression alone. For individuals with lymphedema who failed to respond to conservative therapy, use of pneumatic compression pumps applied to the head or neck was mixed, with respondents citing limited direct experience. Ongoing evidence generation in patients treated for head and neck cancers is expected to elucidate clinical benefit. Respondents also supported the use of novel non-pneumatic compression pumps, noting that the evidence supports their noninferiority compared to traditional, pneumatic devices - and helps to support patient compliance with treatment.

Definitions

Lymphedema refers to the abnormal accumulation of lymph fluid in subcutaneous tissues or body cavities as a result of obstruction of lymphatic flow causing swelling of the extremities. Lymphedema may be subdivided into two types:

• Primary lymphedema, which has no recognizable etiology; and
• Secondary lymphedema, which has a variety of causes including surgical removal of lymph nodes, post-radiation fibrosis, scarring of lymphatic channels, or congenital anomalies.

Treatment of lymphedema may include the use of pharmaceuticals, mechanical appliances, such as compression garments, bandaging, manual massage, lymphedema pumps, or in rare incidences, surgery.

Peripheral vascular disease (PVD) refers to a slow and progressive circulation disorder. Narrowing, blockage, or spasms in a blood vessel can cause PVD and may affect any blood vessel outside of the heart including the arteries, veins, or lymphatic vessels.

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as required by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These polices are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any timeThe identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Investigational; therefore, not covered:

*This code can be used for the Syncardon Device, the Circulator Boot, and other devices used to treat arterial insufficiency.

**This code can be used to bill for a head and neck lymphedema garment.

References

1. DiSipio T, Rye S, Newman B, et al. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. May 2013; 14(6): 500-515. PMID 23540561
2. International Society of Lymphology Executive Committee. The Diagnosis and Treatment of Peripheral Lymphedema: 2023 Consensus Document of the International Society of Lymphology. 2023. https://journals.librarypublishing.arizona.edu/lymph/article/id/6372/ . Accessed November 25, 2024.
3. Oremus M, Walker K, Dayes I, et al. Technology Assessment: Diagnosis and Treatment of Secondary Lymphedema (Project ID: LYMT0908). Rockville, MD: Agency for Healthcare Research and Quality; 2010.
4. Oremus M, Dayes I, Walker K, et al. Systematic review: conservative treatments for secondary lymphedema. BMC Cancer. Jan 04 2012; 12: 6. PMID 22216837
5. 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
6. Hou S, Li Y, Lu W, et al. Efficacy of intermittent pneumatic compression on breast cancer-related upper limb lymphedema: a systematic review and meta-analysis in clinical studies. Gland Surg. Aug 31 2024; 13(8): 1358-1369. PMID 39282029
7. Yao M, Peng P, Ding X, et al. Comparison of Intermittent Pneumatic Compression Pump as Adjunct to Decongestive Lymphatic Therapy against Decongestive Therapy Alone for Upper Limb Lymphedema after Breast Cancer Surgery: A Systematic Review and Meta-analysis. Breast Care (Basel). Jun 2024; 19(3): 155-164. PMID 38894955
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. Dec 2012; 20(12): 3279-3286. PMID 22549506
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. Jan 2012; 131(1): 147-158. PMID 21960113
10. Cheng JT, Leite VF, Tennison JM, et al. Rehabilitation Interventions for Head and Neck Cancer-Associated Lymphedema: A Systematic Review. JAMA Otolaryngol Head Neck Surg. Aug 01 2023; 149(8): 743-753. PMID 37382963
11. Shires CB, Harris P, Dewan K. Feasibility of machine-delivered sequential massage for the management of lymphedema in the head and neck cancer survivor. Laryngoscope Investig Otolaryngol. Jun 2022; 7(3): 774-778. PMID 35734055
12. Gutiérrez C, Mayrovitz HN, Naqvi SHS, et al. Longitudinal effects of a novel advanced pneumatic compression device on patient-reported outcomes in the management of cancer-related head and neck lymphedema: A preliminary report. Head Neck. Aug 2020; 42(8): 1791-1799. PMID 32187788
13. Ridner SH, Dietrich MS, Deng J, et al. Advanced pneumatic compression for treatment of lymphedema of the head and neck: a randomized wait-list controlled trial. Support Care Cancer. Feb 2021; 29(2): 795-803. PMID 32488435
14. Rockson SG, Whitworth PW, Cooper A, et al. Safety and effectiveness of a novel nonpneumatic active compression device for treating breast cancer-related lymphedema: A multicenter randomized, crossover trial (NILE). J Vasc Surg Venous Lymphat Disord. Nov 2022; 10(6): 1359-1366.e1. PMID 35952956
15. Barfield M, Winokur R, Berland T, et al. Results from a comparative study to evaluate the treatment effectiveness of a nonpneumatic compression device vs an advanced pneumatic compression device for lower extremity lymphedema swelling (TEAYS study). J Vasc Surg Venous Lymphat Disord. Jan 2025; 13(1): 101965. PMID 39222789
16. Nelson EA, Hillman A, Thomas K. Intermittent pneumatic compression for treating venous leg ulcers. Cochrane Database Syst Rev. May 12 2014; 2014(5): CD001899. PMID 24820100
17. 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
18. 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
19. Alvarez OM, Markowitz L, Parker R, et al. Faster Healing and a Lower Rate of Recurrence of Venous Ulcers Treated With Intermittent Pneumatic Compression: Results of a Randomized Controlled Trial. Eplasty. 2020; 20: e6. PMID 32636985
20. Bonkemeyer Millan S, Gan R, Townsend PE. Venous Ulcers: Diagnosis and Treatment. Am Fam Physician. Sep 01 2019; 100(5): 298-305. PMID 31478635
21. Lurie F, Malgor RD, Carman T, et al. The American Venous Forum, American Vein and Lymphatic Society and the Society for Vascular Medicine expert opinion consensus on lymphedema diagnosis and treatment. Phlebology. May 2022; 37(4): 252-266. PMID 35258350
22. Lee BB, Andrade M, Antignani PL, et al. Diagnosis and treatment of primary lymphedema. Consensus document of the International Union of Phlebology (IUP)-2013. Int Angiol. Dec 2013; 32(6): 541-574. PMID 24212289
23. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Survivorship. Version 2.2025. May 23, 2025; https://www.nccn.org/professionals/physician_gls/pdf/survivorship.pdf . Accessed June 16, 2025.
24. O'Donnell TF, Passman MA, Marston WA, et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery® and the American Venous Forum. J Vasc Surg. Aug 2014; 60(2 Suppl): 3S-59S. PMID 24974070
25. Marston W, Tang J, Kirsner RS, et al. Wound Healing Society 2015 update on guidelines for venous ulcers. Wound Repair Regen. 2016; 24(1): 136-144. PMID 26663616
26. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for Pneumatic Compression Devices (280.6). 2002; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=225 . Accessed January 30, 2024.