Lymphedema Pump and Appliances (E0650-E0655, E0660-E0673)
Pneumatic compression devices are covered for the treatment of lymphedema of the arm or leg or for the treatment of chronic venous insufficiency with venous stasis ulcers.

Segmental Pneumatic Appliance for the Trunk (E0656) or Chest (E0657)
Segmental pneumatic appliances used with a pneumatic compressor for the treatment of lymphedema of the chest or trunk are considered experimental and investigational. Despite the fact that these devices have received FDA approval, there is a lack of long-term studies demonstrating the efficacy of these devices for the treatment of truncal or chest edema. A participating, preferred, or network provider can bill the member for the denied device.

Date Last Reviewed: 01/2011

Pneumatic Compression Devices Used for the Treatment of Arterial Insufficiency (E0675)
Pneumatic compression devices used for the treatment of arterial insufficiency (E0675) are considered experimental/investigational, and are not eligible for reimbursement. Despite the fact that these devices have received FDA approval, there is a lack of long-term studies demonstrating the efficacy of these devices. A participating, preferred, or network provider can bill the member for the denied device.

Date Last Reviewed: 03/2010

Lymphedema
When prescribed by a physician, the rental or purchase of an intermittent compression unit (segmental, non-segmental) for home use is warranted when lymphedema of the arm or leg exists.

Chronic Venous Insufficiency (CVI)
When prescribed by a physician, pneumatic compression devices are covered in the home setting for the treatment of CVI of the lower extremities only if the patient has one or more venous stasis ulcer(s) that have failed to heal after a six-month trial of conservative therapy directed by the treating physician. The trial of conservative therapy must include a compression bandage system or compression garment, appropriate dressings for the wound, exercise, and elevation of the limb.

General Coverage Criteria
Pneumatic intermittent compression units/lymphedema pumps and appliances may be covered as durable medical equipment (DME) only as a prescription item with appropriate physician oversight (i.e., physician evaluation of the patient's condition to determine medical necessity of the device, suitable instruction in the operation of the machine as to the pressure to be used and the frequency and duration of use, and ongoing monitoring of use and response to treatment).

When pneumatic compression devices are provided for conditions other than those listed, they will be denied as not medically necessary.

Syncardon Therapy
Syncardon therapy (97139) has not been proven to be medically efficacious in the treatment of lymphedema of the extremities. Therefore, Syncardon therapy should be denied as not medically necessary. The rental or purchase of a Syncardon unit (E1399) for home use should also be denied in the same manner.

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider's records.

Coverage for outpatient physical medicine and/or durable medical equipment (DME) is determined according to individual or group customer benefits.

NOTE:

Total payments for a rental item may not exceed its allowable purchase price, except for those items identified as life sustaining DME. For information on continuous rental of life sustaining DME, see Medical Policy Bulletin E-38, Continuous Rental of Life Sustaining Durable Medical Equipment (DME).

Description

Lymphedema Pump and Appliances
A pneumatic intermittent compression unit/lymphedema pump, (e.g., Jobst pneumatic compressor) consists of an inflatable garment for the arm or leg and an electrical pneumatic pump that fills the garment with compressed air. The garment is intermittently inflated and deflated with cycle times and pressures that vary between devices.

Lymphedema
Lymphedema is the swelling of subcutaneous tissues due to the accumulation of excessive lymph fluid. The accumulation of lymph fluid results from impairment to 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 which may be due to such causes as Milroy's Disease or congenital anomalies. Secondary lymphedema, which is much more common, results from the destruction of or damage to formerly functioning lymphatic channels, such as radical surgical procedures with removal of regional groups of lymph nodes (for example, after radical mastectomy), post-radiation fibrosis, and spread of malignant tumors to regional lymph nodes with lymphatic obstruction, among other causes.

Chronic Venous Insufficiency (CVI)
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. Signs of CVI include hyperpigmentation, stasis dermatitis, chronic edema, and venous ulcers.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

Guideline for Management of Wounds in Patients with Lower-Extremity Arterial Disease, Wound, Ostomy, and Continence Nurses Society - Professional Assoc., June 2002

Rapid Foot and Calf Compression Increases Walking Distance in Patients with Intermittent Claudication; Results of a Randomized Study, J Vasc Surg, May 1, 2005; 41(5): 794-801

CMS Pub. 100-3, Medicare National Coverage Determinations Manual, Chapter 1, Section 280.6

DME MAC Jurisdiction A L11503

Effect of intermittent pneumatic compression of foot and calf on walking distance, hemodynamics, and quality of life in patients with arterial claudication: a prospective randomized controlled study with 1-year follow-up. Ann Surg. 2005 Mar;241(3):431-441

Morris RJ. Intermittent pneumatic compression - systems and applications. J Med Eng Technol. 2008 May-Jun;32(3):179-88.

Slovut DP, Sullivan TM. Critical limb ischemia: medical and surgical management. Vasc Med. 2008 Aug;13(3):281-91.

Mayrovitz HN. The standard of care for lymphedema: current concepts and physiological considerations. Lymphatic Research And Biology [Lymphat Res Biol]. 2009;7(2):101-108.

Cannon S. Pneumatic compression devices for in-home management of lymphedema: two case reports. Cases Journal [Cases J]. 2009 Mar 23; Vol. 2, pp. 6625.

Lewin JS, Hutcheson KA, Barringer DA, Smith BG. Preliminary experience with head and neck lymphedema and swallowing function in patients treated for head and neck cancer. Perspectives on Swallowing & Swallowing Disorders (Dysphagia). 2010 Jun;19(2):45-52.

Hammond TM, Mayrovitz HN. Programmable intermittent pneumatic compression as a component of therapy for breast cancer treatment-related truncal and arm lymphedema. Home Health Care Management & Practice. 2010 Oct; 22(6):397-402.