Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers

POLICY NUMBER

A.1.01.18

DESCRIPTION

Pneumatic compression pumps are proposed as a treatment for patients with lymphedema who have failed conservative measures. They are also proposed to supplement standard care for patients with venous ulcers. A variety of pumps are available; they can be single chamber (nonsegmented) or multichamber (segmented) and have varying designs and complexity.

Lymphedema

Lymphedema is an accumulation of fluiddue to disruption of lymphatic drainage. It is characterized by nonpitting swelling of an extremity or trunk, and is associated with wound healing impairment, recurrent skin infections, pain, and decreased quality of life. Lymphedema can be caused by congenital or inherited abnormalities in the lymphatic system (primary lymphedema) but is most often caused by acquired damage to the lymphatic system (secondary lymphedema). Breast cancer treatment (surgical removal of lymph nodes and radiotherapy) is one of the most common causes of secondary lymphedema. In a systematic review of 72 studies (N=29,612 women), it was reported that nearly 20% of breast cancer survivors will develop arm lymphedema. The risk factors with robust evidence for the development of lymphedema included extensive surgical procedures (such as axillary lymph node dissection, a higher number of lymph nodes removed, and mastectomy) as well as being overweight or obese.

Diagnosis and Staging

A diagnosis of secondary lymphedema is based on history (e.g., cancer treatment, trauma) and physical examination (localized, progressive edema and asymmetric limb measurements) when other causes of edema can be excluded. Imaging, such as MRI, computed tomography, ultrasound, or lymphoscintigraphy, may be used to differentiate lymphedema from other causes of edema in diagnostically challenging cases.

Table 1 lists International Society of Lymphology guidance for staging lymphedema (2023) based on "softness" or "firmness" of the limb and the changes with an elevation of the limb.

Table 1. Recommendations for Staging Lymphedema

Management and Treatment

Lymphedema is treated using elevation, compression, and exercise. Conservative therapy may consist of several features depending on the severity of the lymphedema. Individuals are educated on the importance of self-care including hygiene practices to prevent infection, maintaining ideal body weight through diet and exercise, and limb elevation. Compression therapy consists of repeatedly applying padding and bandages or compression garments. Manual lymphatic drainage is a light pressure massage performed by trained physical therapists or by affected individuals designed to move fluid from obstructed areas into functioning lymph vessels and lymph nodes. Complete decongestive therapy is a multiphase treatment program involving all of the previously mentioned conservative treatment components at different intensities. Pneumatic compression pumps may also be considered as an adjunct to conservative therapy or as an alternative to self-manual lymphatic drainage in individuals who have difficulty performing self-manual lymphatic drainage. In individuals with more advanced lymphedema after fat deposition and tissue fibrosis has occurred, palliative surgery using reductive techniques such as liposuction may be performed.

Venous Ulcers

Venous ulcers, which occur most commonly on the medial distal leg, can develop in patients with chronic venous insufficiency when leg veins become blocked. Standard treatment for venous ulcers includes compression bandages or hosiery supplemented by conservative measures such as leg elevation.

Pneumatic Compression Pumps

Pneumatic compression pumps consist of pneumatic cuffs connected to a pump. These pumps 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 in which lymphatic drainage should be preserved. Many PCPs are available, with varying materials, designs, degrees of pressure, and complexity. There are 3 primary types of pumps.

• Single chamber nonprogrammable pumps: They are the simplest pumps, consisting of a single chamber that is inflated at one time to apply uniform pressure.

• Multi-chamber nonprogrammable pumps: They 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 adjust the pressure manually in individual compartments.

• Single- or multi-chamber programmable pumps: They are similar to the pumps described above except that it is possible to adjust the pressure manually in the individual compartments and/or the length and frequency of the inflation cycles. In some situations, including patients with scarring, contractures, or highly sensitive skin, programmable pumps are generally considered the preferred option. PCPs are also proposed to supplement standard care for patients with venous ulcers.

Several pneumatic compression pumps, indicated for the 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 intended for home or clinic/hospital use include the Compression Pump, Model GS-128 (MedMark Technologies); the Sequential Circulator® (Bio Compression Systems); the Lympha-Press® and Lympha-Press Optimal (Mego Afek), the Flexitouch® and Flexitouch Plus systems (Tactile Medical, formerly Tactile Systems Technology); the PowerPress Unit Sequential Circulator (Neomedic); and the EzLymph and EzLymph M (EEZCare Medical).

Several pneumatic compression devices have been cleared by the FDA for treatment of venous stasis ulcers. Examples include the Model GS-128, Lympha-Press, Flexitouch, Flexitouch Plus, and Powerpress Unit (listed above) as well as NanoTherm™ (ThermoTek), CTU676 devices (Compression Technologies), and Recovery+™ (Pulsar Scientific).

Related medical policies include  Bioimpedance Devices for Detection and Management of Lymphedema  and End Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema . 

Pneumatic compression pumps may be used in lymphedema or wound care clinics, purchased, or rented for home use. This policy addresses the home use of these pumps.

POLICY

Single-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 may be considered medically necessary for the treatment of lymphedema when:

1. The individual is otherwise eligible for non-programmable pumps; and

2. There is documentation that the individual has unique characteristics (eg, significant scarring) that prevent satisfactory pneumatic compression with single-compartment or multi-chamber non-programmable lymphedema pumps.

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 with or without involvement of the upper and/or lower limbs is considered investigational.

The use of lymphedema pumps applied to the head and neck to treat lymphedema is considered investigational.

The use of pneumatic compression 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 EXCEPTIONS

Federal 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 GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

This 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."

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

12/1992: 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 consideredinvestigational 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.

11/07/2014: Policy reviewed; description updated regarding comprehensive decongestive therapy, venous ulcers, and devices. Policy statements unchanged.

08/31/2015: Medical policy revised to add ICD-10 codes. Removed ICD-9 diagnosis codes 997.99 and 998.89 from the Code Reference section.

11/20/2015: Policy description updated. Policy statements unchanged. Policy guidelines section updated to add medically necessary and investigative definitions.

05/31/2016: Policy number A.1.01.18 added.

03/23/2017: Policy description updated regarding conservative therapy. Investigational statement regarding treatment of venous ulcers revised to change "lymphedema" to "pneumatic compression."

03/28/2018: Policy reviewed; no changes.

04/03/2019: Policy reviewed; no changes.

04/14/2020: Policy reviewed; no changes.

05/21/2021: Policy description updated regarding pneumatic compression pumps. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

04/14/2022: Policy description updated regarding devices. Added policy statement that the use of lymphedema pumps applied to the head and neck to treat lymphedema is considered investigational.

04/11/2023: Policy reviewed. Investigational policy statement regarding the use of lymphedema pumps to treat the trunk or chest in patients with lymphedema was revised to clarify that it applies regardless of the involvement of the upper and/or lower limbs.

04/11/2024: Policy reviewed; no changes.

02/25/2025: Policy description updated regarding lymphedema, diagnosis and staging, and management and treatment. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 1.01.18 

CODE REFERENCE

This 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.

Covered Codes

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