Appeal type: Medical necessity
Decision: Overturned

Diagnosis: lymphedema
Treatment: Flexitouch lymph drainage system

The Flexitouch lymph drainage system is medically necessary.

The patient is a female. This patient has stage II lymphedema that appears to be hereditary in nature. Her symptoms include swelling, pain, fibrosis, and past cellulitis five years ago. 

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 reviewed. 

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 that 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. 

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 records show that this patient has severe lymphedema that appears to be hereditary in nature. The symptoms have significant adverse impact on her function at home.

The second requirement has been satisfied. The patient has had multiple types of therapy over a period of at least 15 years. The previous therapy has included manual lymphatic drainage (MLD), compression garments, compression wrapping, Biocompression pump, exercise, and elevation. Most recently, starting six months ago, the patient has been in an outpatient lymphedema program. However, none of these treatments have been effective in controlling the patient's symptoms. The Biocompression pump actually made her worse because of increased thigh and groin swelling.

As mentioned above, the records show that the patient tried an E0651 Biocompression pump but that it led to increase swelling and pain. 

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