Appeal type: Medical necessity
Decision: Overturned

Diagnosis:  Lymphedema.
Treatment:  Lymphedema Pump (3-month rental and purchase of 2 E0667NU sleeves for use with the pump).

The insurer denied the Lymphedema Pump (3-month rental and purchase of 2 E0667NU sleeves for use with the pump).  The denial is overturned. 

The patient is a female.  The patient presents with lymphedema/lipedema of the trunk and leg, along with a component of venous insufficiency, as well.  The provider has recommended Flexitouch pump therapy.

Yes, the Lymphedema Pump is medically necessary.

Definitions:
E0650 - nonsegmented pump.
E0651 - segmented pump with differential timing or pressure for the segments (but not programmable).
E0652 - segmented and programmable pump (each segment's pressure can be separately controlled).
Flexitouch - E0652 pump with the addition of a truncal component.  Also uses lower pressures to mimic manual lymphatic drainage (Generally billed as an E0652 pump).

In order to evaluate the medical necessity of Flexitouch in this case, the relevant peer-reviewed literature on the matter of pneumatic pumps for leg swelling due to lymphedema and/or venous insufficiency will first be evaluated. 

There is a scarcity of data about the use of compression pumps for lymphedema and/or severe venous insufficiency.  However, Flexitouch has been studied in more detail than almost any other pump.  The available data include case reports [1-2] and a small, randomized study comparing the Flexitouch device to a Biocontrol E0651 pump [4].  A larger, single-arm study demonstrates significant limb volume reduction and quality-of-life improvement with Flexitouch [5].  The case reports demonstrate, in a preliminary manner, the efficacy of E0650 linear pumps.  The randomized study [4] examined 36 patients with post-mastectomy lymphedema.  For these patients, limb volume reduction was superior for Flexitouch compared to the Biocontrol E0651 pump.  A recent study [5] demonstrated limb volume reduction of 9% in patients treated with Flexitouch, and this reduction was associated with improved quality of life.  There are also some studies, which have examined the role of compression pumps for venous insufficiency, a condition having some similar features to lymphedema [summarized in reference 3].  Some of these studies have demonstrated a useful role for compression pumps for venous insufficiency. 

Based on the above literature summary and current consensus among experts who treat lymphedema, E0652 pumps (e.g. Flexitouch) should be considered medically necessary when the following conditions are met:  1)  The patient has documented severe lymphedema with adverse impact on normal function; 2) A good quality conservative therapy trial has failed; and 3) An E0650 and/or E0651 pump is not effective or useable.

The first requirement has been satisfied.  The submitted medical records show that the patient has severe lymphedema/lipedema and that the symptoms significantly affect her normal function.

The second requirement has been satisfied.  The patient has undergone therapy in a lymphedema clinic.  Records show serial measurements of her legs at multiple levels.  The data demonstrate only slight improvement in limb size despite standard conservative therapy.

The third requirement has been met.  The records show that the patient has significant truncal swelling, a finding which is widely accepted as a contraindication to use a pump lacking a truncal component.

Based on the above discussion, it is concluded that Flexitouch is medically necessary for this patient.

The previous denial was based on the conclusion that the patient failed to meet any the criteria specified in the medical policy for lymphedema.  However, the patient actually meets one of the specified criteria, specifically "detailed measurements over time confirming the persistence of the lymphedema with a history evidencing a likely etiology."  As shown on the "Occupational Therapy Lower Extremity Lymphedema Measurements" form that was submitted with the records, the patient has undergone serial limb measurements demonstrating persistent lymphedema.  The submitted records also show that the etiology of her condition is primary lymphedema, as well as lipedema, with a component as well of venous insufficiency.