Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Lymphedema

Treatment: HCPCS code E0652, pneumatic compressor, segmental home model with calibrated gradient pressure.

The insurer denied coverage for HCPCS code E0652, pneumatic compressor, segmental home model with calibrated gradient pressure.

The denial is upheld.

This is a patient who has been diagnosed with lymphedema of legs. The request is for therapy with HCPCS code E0652, pneumatic compressor, segmental home model with calibrated gradient pressure, which is under review.

The plan requires a four-week trial of a similar, non-segments pump, and regular measurement during this trial, which as not documented.

Lymphedema pumps (pneumatic compression devices) are generally considered medically necessary for home use for the treatment of lymphedema if the member has undergone a four-week trial of conservative therapy and the treating doctor 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.

Flexitouch is a specific device. There is insufficient evidence in the peer-reviewed published medical literature that a 2-phase lymph preparation and drainage therapy device (Flexitouch Device, Tactile Systems Technology, Minneapolis, MN) provides superior outcomes to standard segmented pneumatic compression devices.

Per Lerman, M., et al., (2019), "Mechanical pneumatic pumps use electricity to inflate a single-chamber or multi-chamber sleeve that produces external limb compression. A decreased tissue capillary filtration rate facilitates tissue fluid reduction and, consequently, limb volume decrease. Lymph formation decreases, but lymph transport is not improved. Pneumatic pumps can reduce swelling, but concern exists regarding the way in which the rapid displacement of fluid in the other areas of the body. The use of pumps does not eliminate the need for compression garments and may not provide more benefit than garments alone. Using pumps may cause complications, including lymphatic congestion and injury proximal to the pump sleeve, and increased swelling adjacent to the pump cuff in up to 18% of patients."

Per Zaleska, M., Olszewski, W. L., & Durlik, M. (2014), "The very high number of cases, estimated by the World Health Organization (WHO) around 300 million, requires simple, inexpensive, and easily accessible compression devices all over the world. Although manual lymphatic drainage and its various modifications have proved to be successful, the problem of its accessibility for patients cannot be solved due to the insufficient number of therapists for those large cohorts of patients. The only solution is mechanization of the compression method using pneumatic devices. The construction and function of these devices should be based on the physiological parameters of tissue fluid (edema fluid) hydromechanics. We measured the tissue fluid (edema fluid) (TF) pressures and flow using various types of pneumatic compression devices in a group of patients with lower limb lymphedema and estimated the most effective parameters for fluid movement."

Per Wang, D., Lyons, D., & Skoracki, R. (2020), "Compression Decongestive Therapy (CDT) is both time consuming and labor intensive and adds a significant cost beyond that of compression garments alone. Several recent studies, although underpowered, showed no difference between CDT and less intensive methods."           

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for HCPCS code E0652, pneumatic compressor, segmental home model with calibrated gradient pressure is not substantiated.