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DESCRIPTIONLymphedema is an abnormal accumulation of lymph fluid in subcutaneous tissues or body cavities due to obstruction of lymphatic flow. Lymphedema can be subdivided into primary and secondary lymphedema. Primary lymphedema has no recognizable etiology, while secondary lymphedema is related to a variety of causes including surgical removal of lymph nodes, post-radiation fibrosis, scarring of lymphatic channels or congenital anomalies. Treatment options include mechanical measures (compression garments, bandaging, manual massage, pneumatic compression devices (i.e., lymphedema pumps), drugs, or rarely, surgery.
Lymphedema pumps consist of pneumatic cuffs that are connected to a pump. They use compressed air to apply pressure to the affected limb. The intention is to force excess lymph fluid out of the limb and into central body compartments where lymphatic drainage should be preserved. Many different pneumatic compression pumps for treating lymphedema are available, with varying materials, design, degree of pressure and complexity. There are three primary types of pumps as follows:
Recently, a new type of pump has been introduced, a two-stage multi-chamber pump. One device of this type, the Flexitouch™ system, has 27-32 chambers and includes 13 sequential treatment programs for different regions of the body. Treatment sessions consist of 2 phases, meant to simulate manual lymph drainage. The first phase is preparation of the affected area for drainage which uses a proximal-to-distal gradient and the second phase is drainage which uses a distal-to-proximal gradient. The Flexitouch system includes a variety of garment types. For treating an upper extremity, chest and trunk garments are used in addition to the arm garment. When treating a lower extremity, a trunk garment is used with a calf-foot garment. This allows treatment of the truncal area in addition to the affected limb.
Several pneumatic compression pumps indicated for primary or adjunctive treatment of primary or secondary (e.g., post-mastectomy) lymphedema have been cleared for marketing by the FDA through the 510(k) process. Examples of devices with these indications that are intended for home or clinic/hospital use include the Compression pump, Model GS-128 (Medmark Technologies, LLC); the Sequential Circulator (BioCompression Systems, Inc.); and the Lympha-Press (Mego Afek, Israel). Device manufacturers generally have a line of products for different applications and to treat different affected areas of the body. A pump with another variation in pump design, the Flexitouch™ (Tactile Systems Technology, Inc.) was cleared by the FDA in 2006.
Related medical policies include Bioimpedence Devices for Detection of Lymphedema and End Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema.
Lymphedema pumps may be used in lymphedema clinics or purchased or rented for home use. This policy addresses the home use of lymphedema pumps.
POLICYSingle compartment or multi-chamber non-programmable lymphedema pumps applied to the limb may be considered medically necessary for the treatment of lymphedema that has failed to respond to conservative measures such as elevation of the limb and use of compression garments.
Single compartment or multi-chamber programmable lymphedema pumps applied to the limb are considered medically necessary for the treatment of lymphedema when:
Single compartment or multichamber lymphedema pumps applied to the limb are considered investigational in all situations other than those specified above in the first two policy statements.
The use of lymphedema pumps to treat the trunk or chest in patients with lymphedema limited to the upper and/or lower limbs is considered investigational.
The use of lymphedema pumps to treat venous ulcers is considered investigational.
Pneumatic compression devices prescribed for patients undergoing surgery as a means of prophylaxis to prevent Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) should be included in the surgical facility's claim. This does not meet the criteria for Durable Medical Equipment and may not be billed separately. It is not appropriate for providers to bill the patient for this service.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESThis policy is consistent with The Medicare Coverage Issues Manual which states the following : "In general, the nonsegmented (E0650) or segmented (E0651) compression device without manual control of pressure in each chamber is considered the least costly alternative that meets the clinical needs of the individual. Therefore, when a claim for a segmented pneumatic compression device that allows for manual control in each chamber is received, payment must be made for the least expensive medically appropriate device. If a patient medically needs a segmented device but does not need manual controls, payment must be made for E0651. The segmented device with manual control (E0652) is covered only when there are unique characteristics that prevent the individual from receiving satisfactory pneumatic treatment using a less costly device; e.g., significant sensitive skin scars or the presence of contracture or pain caused by a clinical condition that requires the more costly manual control device."
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY12/1992: Approved by Medical Policy Advisory Committee (MPAC) as "Segmental Lymphedema Pump"
8/1997: Revision approved by MPAC; policy renamed
2/19/2002: Managed Care Requirements deleted
5/1/2002: Type of Service and Place of Service deleted
8/19/2002: HCPCS code E0652 description added
9/20/2002: Policy reviewed, Sources updated
8/21/2003: HCPCS E0650-E0651, E0655-E0673 listed separately
10/17/2005: ICD-9 Diagnosis 990 deleted
7/13/2006: Policy updated
1/2/2007: Code reference section updated per the 2007 CPT/HCPCS revisions.
11/20/2008: Policy reviewed by MPAC, no changes
12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions
08/12/2010: Policy title changed from "Lymphedema Pumps" to "Pneumatic Compression Pumps for Treatment of Lymphedema." Policy description revised to add information regarding available pumps. Links added to related medical policies. The first policy statement was revised to add "non-programmable" and the term "elastic" was changed to "compression." Policy statement regarding multi-chamber programmable lymphedema pumps was changed from not medically necessary to medically necessary under certain circumstances; single compartment programmable pumps are addressed in the same policy statement. Added policy statement to indicate that two-phase multi-chamber lymphedema pumps are investigational for treatment of lymphedema. FEP verbiage added to the Policy Exceptions section.
09/09/2010: Policy description updated to add information regarding compression pumps for treating truncal areas. Policy statement unchanged.
09/23/2011: Added the following to the Policy Statement: Single compartment or multichamber lymphedema pumps are considered investigational in all situations other than those specified above in the first two policy statements. Deleted outdated References from the Sources section.
02/17/2012: Add the following to the Policy Statement: Pneumatic compression devices prescribed for patients undergoing surgery as a means of prophylaxis to prevent Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) should be included in the surgical facility's claim. This does not meet the criteria for Durable Medical Equipment and may not be billed separately. It is not appropriate for providers to bill the patient for this service.
01/07/2013: Added "Venous Ulcers" to the policy title. Policy statement revised to add the following investigational statements: 1)The use of lymphedema pumps to treat the trunk or chest in patients with lymphedema limited to the upper and/or lower limbs is considered investigational. 2) The use of lymphedema pumps to treat venous ulcers is considered investigational. Deleted the following policy statement: Two-phase multi-chamber lymphedema pumps are investigational for treatment of lymphedema. Added the following new 2013 CPT code to the Code Reference section: E0670.
03/19/2014: Added "applied to the limb" to the first 3 policy statements for clarification.
SOURCE(S)Blue Cross Blue Shield Association policy # 1.01.18
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.