Bioimpedance Devices for Detection and Management of Lymphedema

POLICY NUMBER

A.2.01.82

DESCRIPTION

Secondary lymphedema may develop following treatment for breast cancer. Bioimpedance, which uses resistance to electrical current to compare the composition of fluid compartments, could be used as a tool to diagnose lymphedema.

Lymphedema

Lymphedema is an accumulation of fluid due 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, 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 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.

Bioimpedance Spectroscopy

Bioimpedance spectroscopy is based on the theory that the level of opposition to the flow of electric current (impedance) through the body is inversely proportional to the volume of fluid in the tissue. In lymphedema, with the accumulation of excess interstitial fluid, tissue impedance decreases.

Bioimpedance has been proposed as a diagnostic test for this condition. In usual care, lymphedema is recognized clinically or via limb measurements. However, management via bioelectrical impedance spectroscopy has been proposed as a way to implement early treatment of subclinical lymphedema to potentially reduce its severity.

A selection of devices that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process to aid in the assessment of lymphedema are summarized in the table below. Among the FDA-approved bioimpedance devices are SOZO (ImpediMed), MoistureMeterD (Delfin Technologies), and the L-Dex U400 (ImpediMed). The L-Dex U400 was discontinued by its manufacturer in November 2018.

Table 2. FDA Cleared Bioimpedance Spectroscopy Devices for Lymphedema

Related medical policies are  Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers and End Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema .

POLICY

Bioimpedance spectroscopy may be considered medically necessary to confirm a diagnosis of lymphedema in the following clinical scenario:

1. The individual is asymptomatic with history of surgery, radiotherapy, or trauma impacting the lymphatic system, and testing would guide decisions regarding early intervention (eg, physical therapy, complete decongestive therapy).

Bioimpedance spectroscopy may be considered medically necessary for surveillance of lymphedema in the following clinical scenarios:

1. The individual is asymptomatic with history of surgery, radiotherapy, or trauma impacting the lymphatic system, and testing would guide decisions regarding early intervention (eg, physical therapy, complete decongestive therapy); OR

2. The individual remains symptomatic following a course of conservative therapy for lymphedema, and testing would guide decisions regarding escalation of therapy (eg, liposuction, surgery) (see Policy Guidelines).

Bioimpedance spectroscopy is considered investigational outside of the aforementioned clinical scenarios.

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.

Medically necessary positions are based on clinical input. For individuals with clinically diagnosed and/or symptomatic lymphedema, bioimpedance spectroscopy provides limited incremental utility for the optimization of decongestive therapy - but may confirm maximal expected benefit from conservative therapies and thus inform decisions concerning treatment escalation.

An optimal surveillance frequency in individuals at high-risk for the development of secondary lymphedema has not been established. Lymphedema experts generally recommend assessments every 3-6 months for a minimum of 3 years after cancer treatment on the basis of the PREVENT RCT.

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

07/22/2010: Approved by Medical Policy Advisory Committee

01/18/2012: Policy reviewed; no changes.

03/13/2013: Policy reviewed; no changes to policy statement. Added CPT code 0239T to the Code Reference section.

03/26/2014: Policy title changed from "Bioimpedance Devices for Detection of Lymphedema" to "Bioimpedance Devices for Detection and Management of Lymphedema." Policy statement unchanged.

12/31/2014: Added the following new 2015 CPT code to the Code Reference section: 93702.

01/07/2015: Policy reviewed; description updated. Policy statement unchanged.

07/08/2015: Code Reference section updated for ICD-10.

03/08/2016: Policy description updated. Policy statement unchanged. Investigative definition updated in policy guidelines section. Code Reference section updated to remove deleted CPT code 0239T.

06/01/2016: Policy number A.2.01.82 added.

07/17/2017: Policy description updated regarding devices. Policy statement unchanged.

01/31/2018: Policy description updated regarding lymphedema. Policy statement unchanged.

02/15/2019: Policy description updated regarding devices. Policy statement unchanged.

02/07/2020: Policy description revised regarding lymphedema, diagnosis and staging, management and treatment, and devices. Policy statement unchanged.

02/10/2021: Policy reviewed; no changes.

02/08/2022: Policy description updated. Policy statement unchanged.

02/14/2023: Policy description and policy statement updated to change "patients" to "individuals."

02/28/2024: Policy description updated regarding recommendations for staging lymphedema. Policy statement unchanged.

03/05/2025: Policy description updated regarding lymphedema indications, recommendations for staging lymphedema, and devices. Policy statement unchanged.

10/01/2025: Policy reviewed. Policy statement changed from investigational to medically necessary. Added policy statements that bioimpedance spectroscopy may be considered medically necessary to confirm a diagnosis or for surveillance of lymphedema based on the clinical scenarios listed. Bioimpedance spectroscopy is considered investigational outside of the aforementioned clinical scenarios. Policy Guidelines updated regarding clinical input and to define medically necessary. Code Reference section updated to change the listed codes from investigational to medically necessary. Removed CPT code 38999 and added ICD-10 diagnosis codes I97.2 and Z90.10 - Z90.13.

SOURCE(S)

Blue Cross Blue Shield Association Policy # 2.01.82

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.

Medically Necessary Codes

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