Lymphedema Devices
DESCRIPTION
Lymphedema is an abnormal accumulation of lymphatic fluid in subcutaneous tissue. This might be the result of a congenital anomaly or damage to the lymphatic system (e.g., removal of lymph nodes, blockage of lymphatic channels by a tumor, scarring of lymphatic channels from radiation, or as a result of surgery or trauma). Lymphedema can occur immediately following surgery or years later. Lymphedema is a chronic condition for which there is no cure. If the condition is not treated it can result in skin deterioration, fibrosis, and loss of limb mobility.
Pneumatic compression devices use compressed air to apply pressure to the affected limb. This forces excess lymph fluid out of the limb and into central body compartments, where lymphatic drainage should be preserved. These systems consist of a pneumatic sleeve or boot that is attached to a compression pump via hoses. The appliance is intermittently inflated with air, which provides a squeezing or "milking action" to facilitate the flow of lymph from the affected limb. The appliance then deflates allowing for circulation within the limb. Repeated cycles reduce the lymphedema. Following treatment, a pressure garment is worn on the extremity. There are several types of compression pumps.
Single-chamber nonprogrammable pumps: These are the simplest pumps, consisting of a single chamber that is inflated at one time that applies uniform pressure.
Multichamber nonprogrammable pumps: These pumps have multiple chambers, ranging from 2 to 12 or more. The chambers are inflated sequentially and have a fixed pressure in each compartment. They can either have the same pressure in each compartment or a pressure gradient, but they do not include the ability to manually adjust the pressure in individual compartments.
Single- or multichamber programmable pumps: These are similar to the pumps described above except that it is possible to make manual adjustments in the pressure in the individual compartments and/or the length and frequency of the inflation cycles. In some situations, including in patients with scarring, contractures, or highly sensitive skin, programmable pumps are generally considered to be the preferred option.
A new multi-phased pump has also been investigated for treating lymphedema. The newer devices the Flexitouch™ (Tactile Systems Technology, Inc.) pump and the Lympha Press Optimal® (Mego Afek, Israel) consist of 2 phases and are meant to simulate manual lymph drainage. The first phase, a pretreatment or preparation phase, uses a proximal-to-distal gradient to clear the proximal lymphatics. The second phase, lymph drainage, uses a distal-to-proximal gradient. Garment design and controller programs provide treatment to truncal lymphatics in addition to the affected limb.
POLICY
Lymphedema compression pumps, single compartment or multi-chamber, for the treatment of intractable lymphedema involving one or more limbs, are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Multi-phasic lymphedema pumps (e.g. Flexitouch™, Lymph Press Optimal®) for treatment of lymphedema. are considered investigational.
Lymphedema pumps for the treatment of condition/disease other than lymphedema are considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
See also:
End Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema
MEDICAL APPROPRIATENESS
Lymphedema compression pumps, single or multi-chamber, are considered medically appropriate if ALL of the following criteria are met:
Individual has intractable lymphedema of one or more limbs
Device is prescribed and progress is monitored by a physician
The individual has failed to demonstrate significant improvement of symptoms to ALL the following conservative measures:
Limb elevation
Exercise
Manual lymphedema drainage
Compression therapy
ABSENCE of ALL of the following:
Infection
Venous or arterial occlusive disease
Venous thrombosis
Massive edema secondary to congestive heart failure
Metastatic disease in the involved extremity
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
This policy does not address end-diastolic compression pumps which are a very specialized pneumatic compression pump designed to coordinate the timing of the intermittent boot compression with the QRS complex on the EKG.
There is an absence of adequate peer-reviewed literature demonstrating the effectiveness of multi-phased compression systems and an absence of comparison to currently accepted treatment modalities with well-defined, clinically relevant health outcomes.
SOURCES
Agency for Healthcare Research and Quality. (2010, May). Diagnosis and treatment of secondary lymphedema. Retrieved September 26, 2011from http://www.ahrq.gov.
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2011). Pneumatic compression pumps for the treatment of lymphedema (1.01.18). Retrieved September 23, 2011 from BlueWeb. (9 articles and/or guidelines reviewed)
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, April). Pneumatic compression (NCD 280.6, p. 2-128). The Ingenix Complete Guide to Medicare Coverage Issues.
Mayrovitz, H. N. (2007). Interface pressures produced by two different types of lymphedema therapy devices. Physical Therapy, 87, (10), 1379-1388. (Level 4 Evidence - Industry sponsored)
National Cancer Institute. (2008, September). Lymphedema. Retrieved June 2, 2009 from http://www.cancer.gov/cancertopics/pdq/supportivecare/lymphedema/healthprofessional/allpages.
Ridner, s., Murphy, B., Deng, J., Kidd, N., Galford, E., & Dietrich, M. (2010). Advanced pneumatic therapy in self-care of chronic lymphedema of the trunk. Lymphatic Research and Biology, 8 (4), 209-215. (Level 4 Evidence - Industry supported)
Szuba, A., Achalu, R., & Rockson, S. G. (2002). Decongestive lymphatic therapy for patients with breast carcinoma-associated lymphedema. A randomized, prospective study of a role for adjunctive intermittent pneumatic compression. Cancer, 95 (11). 2260-2267. (Level 3 Evidence - Independent study)
U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. (2005, May). NCD for durable medical equipment reference list (280.1). Retrieved June 2, 2009 from http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=280.1&ncd_version=2&basket=ncd%3A280%2E1%3A2%3ADurable+Medical+Equipment.
U. S. Food and Drug Administration. (2006, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K062818. Retrieved June 2, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf6/K062818.pdf.
U. S. Food and Drug Administration. (2008, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K082149. Retrieved June 2, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K082149.pdf.
Wilburn, O., Wilburn, P., & Rockson, S. G. (2006). A pilot, prospective evaluation of a novel alternative for maintenance therapy of breast cancer-associated lymphedema [ISRCTN76522412]. BMC Cancer, 6 (84). (Level 4 Evidence - Industry sponsored)
ORIGINAL EFFECTIVE DATE: 6/1998
MOST RECENT REVIEW DATE: 2/12/2012
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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