Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Lymphedema
Treatment: Pneumatic Compression Device
The insurer denied the Pneumatic Compression Device
The determination is overturned.

The patient has stage 3 bilateral lower extremity lymphedema. His main symptoms include pain and swelling. He has attempted and failed conservative therapy with graded compression stockings and garments, leg elevation, and exercise. His symptoms affect his activities of daily living and quality of life. At issue is the medical necessity of pump and garment (pneumatic compression device).
The pump and garment (pneumatic compression device) is medically necessary for this patient based on the peer reviewed literature The patient is a good candidate for the requested pneumatic compression device. He has failed conservative and alternative therapies. The peer reviewed literature supports the use of the pneumatic compression pump for this patient. There is sufficient published, peer-reviewed data from well-constructed clinical trials to permit scientific conclusion regarding the lasting benefit to health outcomes from the use of the requested compression pump for treating lymphedema of the extremity and trunk as requested for this patient. There are several high-quality publications supporting the use of lymphedema pumps for refractory lymphedema as demonstrated by this patient.
Fife and colleagues demonstrated superior results with advanced programmable pneumatic compression devices (APCD) compared with standard pneumatic compression devices (SPCD) in their 2012 study. In their outcomes, they demonstrated that the APCD-treated group experienced an average of 29% reduction in edema compared to a 16% increase in the SPCD group. Mean changes in time density curve (TDC) values were a 5.8% reduction for the APCD group and a 1.9% increase for the SPCD group.
Ridner and colleagues also demonstrated excellent results with a programmable, pneumatic compression pump in patients with post-mastectomy lymphedema. The purpose of this study was to conduct a preliminary, post-market, home study of the Flexitouch() system to examine the potential efficacy of the device as a component of self-care in breast cancer survivors with truncal lymphedema. A quasi-experimental, pre-treatment, post-treatment design was used. Twelve participants received a total of ten self-administered, consecutive, one hour per day treatments. Treatments one and two were observed by study staff and the remaining eight were unobserved. Assessments were conducted at baseline, after the first two treatments, mid-way through therapy, and at the end-of-study. Logs revealed 100% compliance with the eight prescribed unobserved home treatments. Symptoms were assessed by self-report symptom surveys. Signs, objectively observed physical phenomenon, were assessed by staff-initiated skin examination and circumferential truncal measurements. Statistically significant improvement in truncal symptoms and sleep were found. Changes in function and girth were not statistically significant in this initial study. Breast cancer survivors with truncal lymphedema may benefit from using an advanced pneumatic compression device with truncal treatment as part of their self-care program. Participants were highly compliant in device use. Further research of this intervention is warranted. To facilitate future research, clinically meaningful reductions in truncal girth should be defined.
Adams and colleagues also showed that pneumatic compression devices stimulate lymphatic function and may be an effective method to manage lymphedema. The study employed an investigational, near-infrared flouresence imaging technique to evaluate lymphatic response to pneumatic compression therapy and demonstrated favorable outcomes.
Fife and Carter reviewed the benefits of lymphedema treatment in the morbidly obese and demonstrated that the condition is a clear risk factor for lymphedema, thus creating a feedback loop in these patients. In their review article, they noted that the presence of lymphedema increases the risk of becoming morbidly obese. They also noted that pneumatic compression pumps can be highly beneficial in obese patients, particularly for decompressing areas which cannot be bandaged appropriately.