Pneumatic compression devices consist of an inflatable garment for the arm or leg and an electrical pneumatic pump. The garment is intermittently inflated and deflated with cycle times and pressures that vary between devices. Pneumatic compression devices are used in clinics or can be purchased or rented for home use. This document addresses the home use of pneumatic compression devices.

Medically Necessary: 

Single or multi-chamber non-programmable pneumatic compression devices are considered medically necessary when:

• The individual's lymphedema is not improving and the individual has been compliant with conservative therapy (i.e., elevation of the affected limb, exercise, massage, use of an appropriate compression bandage system or compression garment); or
• The individual has generalized refractory edema from venous insufficiency and there are one or more venous stasis ulcers which have failed to heal despite compliancy and conservative therapy for six months.

Single or multi-chamber programmable pneumatic compression devices are considered medically necessary when:

• The individual's condition prevents satisfactory pneumatic compression treatment with a single or multi chamber, non-programmable pneumatic compression device. Such conditions include significant scarring, sensitive skin or contracture. 

Not Medically Necessary:

Single or multi-chamber programmable or non-programmable pneumatic compression devices are considered not medically necessary when the criteria above have not been met.

Two-stage multi-chamber programmable pneumatic compression devices (e.g., Flexitouch^™_, LymphaPress Optimal^™)are considered not medically necessary for all indications.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. 

Lymphedema is characterized by swelling of subcutaneous tissues due to the accumulation of excessive lymph fluid resulting from impairment of the normal clearing function of the lymphatic system and/or from an excessive production of lymph.  Lymphedema is divided into two broad classes according to etiology. Primary lymphedema is a relatively uncommon, chronic condition due to congenital absence of lymph vessels and nodes, and may be due to Milroy's Disease.  Secondary lymphedema, which is much more common, results from the destruction or damage of formerly functioning lymphatic channels.  Examples include radical surgical procedures with removal of regional groups of lymph nodes (e.g., after radical mastectomy), post-radiation fibrosis, and spread of malignant tumors to regional lymph nodes with lymphatic obstruction.  Treatment for lymphedema may include mechanical measures (e.g., compression garments, bandaging, manual massage, pneumatic compression devices), drugs, and in rare cases, surgery.

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 as well as lymphatic circulation.  This compromises the surrounding tissue causing hyperpigmentation, stasis dermatitis, chronic edema, and/or venous ulcers.  The circulation of blood depends on the pumping action of the heart.  The circulation of lymph depends upon skeletal muscle contractions.  Impairment of lymphatic circulation may result in compromised delivery and removal of fluids to tissues, which may result in impaired wound healing and proper functioning of the skin and skeletal muscles.

Pneumatic compression devices are used commonly in the treatment of lymphedema and chronic venous insufficiency. Pneumatic compression devices, also known as lymphedema pumps, are used to simulate muscle action in the extremities and lower body to stimulate lymph and blood circulation with the goal of decreasing edema due to accumulation of lymphatic fluid.  These devices involve the use of sleeve or wrap-like garments which contain one or several inflatable air chambers.  Attached to the garment is a control unit which controls the flow of compressed air into the air chamber.  During treatment the air chambers inflate in a distal to proximal fashion, squeezing the body in such a way as to encourage lymphatic fluid to flow back to the heart.  Some devices come with control units that are programmable, allowing variation in the duration and frequency of the inflation cycles, as well as the degree of compression in individual air chambers in the garment.  The ability to vary different aspects of this type of treatment has been suggested as a method of optimizing the treatment process, but there is no evidence to demonstrate the superiority of programmable devices compared to non-programmable devices.  However, in some situations, scarring, contractures or highly sensitive skin require the use of a programmable device.

Compression pumps are used commonly in the management of lymphedema.  A limited number of small studies have been published.  Szuba and colleagues (2002) reported on two small randomized controlled trials (n=23 and 27 respectively).  The results of these studies showed that during initial treatment, standard therapy plus pneumatic compression for treatment-naive subjects resulted in significant limb volume reduction compared to standard care alone.  However, they found that during the maintenance period, these benefits did not persist in some individuals.  In contrast to these findings, earlier small, randomized controlled studies by Johansson et al (1998), and Dini and colleagues (1998) found no significant difference between pneumatic pump therapy when compared to either no care or standard care groups.

Another type of pneumatic compression device is a two-stage multi-chamber programmable pneumatic compression device (e.g. Flexitouch^™ [Tactile Systems Technology Inc. Minneapolis, MN]; LymphaPress Optimal^™ [Lympha Press USA, Manalapan, NJ],). This type of device operates in two separate phases over the course of a treatment period.  The first phase is referred to as the "preparation phase" and has been proposed to help prepare the treated limb(s) and torso for the "drainage phase".  The preparation phase consists of light variable pressure to gently massage the treated portions of the body as a method of improving lymph drainage.  The drainage phase uses light variable pressure, but in a distal to proximal direction, to move lymphatic fluid back to the heart.  Additionally, some of these devices come with a component that wraps around the torso and delivers compression treatment to this part of the body in addition to the affected limb. The benefits provided by this additional torso component have not been adequately investigated at this time. 

The available evidence addressing the clinical use of two-stage multi-chamber programmable pneumatic compression devices is limited.  In addition to several case reports published in journals not recognized in the National Library of Medicine's PubMed database (Cannon, 2009; Hammond, 2009a, 2009b), there is one case series study and one randomized controlled trial available.  The Ridner (2008) case series study initially included 286 participants who underwent treatment with the Flexitouch devices for 2 months.  Prior to treatment, and 2 months following the initiation of treatment, the subjects were asked to respond to a survey instrument regarding Quality of Life (QOL) and satisfaction with the device.  While this study is interesting, the findings are not particularly useful in ascertaining the health impact of the device.  In addition to methodological flaws such as the use of self reported data, lack of a control group, no blinding and a significant loss to follow-up (36%), the study does not report health-related outcomes, such as limb volume reduction, skin tension and elasticity, and limb heaviness. The only available randomized controlled cross-over trial currently available included 10 subjects and provided no comparison to conventional pump therapy with a short follow-up period of 4 weeks (Wilburn, 2006). 

Pneumatic compression devices are approved under the U.S. Food and Drug Administration's (FDA's) 510(k) process. They are classified as Class II devices, cardiovascular therapeutic devices, and compressible limb sleeves.

Peer Reviewed Publications: 

1. Berliner E, Ozbilgin B, Zarin, DA. A systematic review of pneumatic compression for treatment of chronic venous insufficiency and venous ulcers. J Vasc Surg. 2003; 37(3):539-544.
2. Cannon S. Pneumatic compression devices for in-home management of lymphedema: two case reports. Cases J. 2009; 2:6625.
3. Dini D, Del Mastro L, Gozz A, et al. The role of pneumatic compression in the treatment of postmastectomy lymphedema. A randomized phase III study. Ann Oncol. 1998; 9(2):187-190.
4. Hammond T. Reduction of complications and costs associated with Flexitouch therapy for lymphedema. Open Rehabil J. 2009; 2:54-57.
5. Hammond T. Can truncal edema be treated with pneumatic compression? LymphLink. 2009; 21(2):12-14.
6. Johansson K, Lie E, Ekdahl C, Lindfeldt J. A randomized study comparing manual lymph drainage with sequential pneumatic compression for treatment of postoperative arm lymphedema. Lymphology. 1998; 31(2):56-64.
7. Macdonald JM, Sims N, Mayrovitz HN. Lymphedema, lipedema and the open wound: the role of compression therapy. Surg Clin North Am. 2003; 83(3):639-658.
8. Pappas CJ, O'Donnell TF Jr. Long-term results of compression treatment for lymphedema. J Vasc Surg. 1992; 16(4):555-562.
9. Ridner SH, McMahon E, Dietrich MS, Hoy S. Home-based lymphedema treatment in patients with cancer-related lymphedema or noncancer-related lymphedema. Oncol Nurs Forum. 2008; 35(4):671-680.
10. Smith PC, Sarin S, Hasty J, Scurr JH. Sequential gradient pneumatic compression enhances venous ulcer healing: a randomized trial. Surgery. 1990; 108(3):871-875.
11. 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):2260-2267.
12. Wilburn O, Wilburn P, Rockson SG. A pilot, prospective evaluation of a novel alternative for maintenance therapy of breast cancer-associated lymphedema. BMC Cancer. 2006; 6:84.
13. Zanolla R, Monzeglio C, Balzarini A, Martino G. Evaluation of the results of three different methods of postmastectomy lymphedema treatment. J Surg Oncol. 1984; 26(3):210-213.

Government Agency, Medical Society, and Other Authoritative Publications: 

1. Centers for Medicare and Medicaid Services. National Coverage Determination: Pneumatic Compression Devices. NCD #280.6. Effective January 14, 2002. Available at: http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on June 15, 2011.
2. International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2009 Consensus Document of the International Society of Lymphology. Lymphology. 2009; 42(2):51-60.
3. Kolbach DN, Sandbrink MWC, Prins MH, Neumann MHAM. Compression therapy for treating stage I and II (Widmer) post-thrombotic syndrome. Cochrane Database of Systematic Reviews 2003, Issue 4. Art. No.: CD004177.

Compression Devices
Flexitouch^™
Lymphedema
Lymphedema Pumps
LymphaPress Optimal^™
NormaTec PCD
Pneumatic
Venous Insufficiency

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.