Medicare Advantage

Medical Policy

Title:

Bioimpedance for the Detection of Lymphedema

Policy #:

MA07.052

Policy

Although the US Food and Drug Administration (FDA) has approved devices for bioimpedance for the detection of lymphedema, the Company has determined that the effectiveness of this procedure cannot be established by review of the available published peer-reviewed literature. Therefore, bioimpedance for the detection of lymphedema is considered experimental/investigational by the Company and not covered.

Guidelines

There is no Medicare coverage determination addressing this service; therefore, the Company policy is applicable.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, bioimpedance for the detection of lymphedema is not eligible for payment under the medical benefits of the Company's Medicare Advantage products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are excluded for the Company's Medicare Advantage products. Therefore, they are not eligible for reimbursement consideration.

US FOOD AND DRUG ADMINISTRATION (FDA)

There are numerous devices approved by the FDA for bioimpedance for the detection of lymphedema.

Description

Lymphedema is a condition characterized by excess edema and protein in the tissues caused by fluid that is not drained by the lymphatic system. The lymphatic system is part of the body's circulatory system, and its main function is to drain fluid, absorb fats, maintain the body's fluid balance, and help defend the body against disease. The failure of this system can lead to lymphedema and other conditions.

There are two types of lymphedema: primary and secondary. Primary lymphedema is an inherited condition and is determined by genetic factors. Secondary lymphedema is usually caused by trauma, radiation therapy, surgery, or infection that causes a disruption in the lymphatic channels or loss of lymph nodes.

In time, lymphedema can lead to recurring infections, pain, and decreased or loss of function and mobility. Control of the condition usually involves exercise, compression bandaging, and massage. The practice of measuring limb girth with tape measures or the immersion of the limb in water to measure the displacement of the water is considered the gold standard for detection of lymphedema. One of the many problems associated with lymphedema involves early detection; however, detection in the early subclinical phase is difficult. While there is no cure for lymphedema, early detection and treatment are critical in achieving the optimal outcome for the individual.

There are five grades of lymphedema, using the Miller Classification:

Grade 0 (subclinical): Individual has abnormal or non-efficient lymph rerouting but does not have clinical edema.
Grade 1: Normal in appearance, positive for pitting edema, edema resolves or greatly decreases with elevation of the limb.
Grade 2: Skin on affected limb develops yellowish discoloration, there is skin thickening, positive for pitting under moderate pressure, moderate decrease in edema with elevation, loss of limb mobility and function as edema increases, physical therapy is necessary.
Grade 3: Development of vesicles and papules on the affected limb, keratosis of the effective limb, skin thickening with little pitting on pressure, minimal decrease of edema with elevation, decreased function and mobility of affected limb, physical therapy and medical intervention are necessary.
Grade 4: Increased yellowish discoloration, increased pigmentation, weeping vesicles, increased keratotic papules, increased skin thickening, no pitting with pressure, no decrease in edema with elevation, marked loss of limb function and mobility, multimodality therapy is required.

The detection of lymphedema at a subclinical level is a current area of study. The detection of grade 0 lymphedema is problematic and may be present for months or years without physical manifestation. Optimally, the "at risk" limb is tested pre- and post-surgery (eg, mastectomy or lumpectomy with lymph node dissection) using bioimpedance spectroscopy. Bioimpedance spectroscopy (ie, impedance plethysmography) is a measure of the resistance met by a current passed through the skin via electrodes. The difference appreciated between the readings pre- and post-surgery is proposed to determine the presence or lack of lymphedema.

Currently, there is little information regarding the technical and diagnostic performance of bioimpedance testing for the detection of lymphedema. Also, there are no comparative clinical trials that demonstrate the impact of bioimpedance on clinical outcomes. The approach to subclinical lymphedema (diagnosis and treatment) appears to be under active investigation.

References

Barrio AV, Eaton A, Frazier TG. A Prospective Validation Study of Bioimpedance with Volume Displacement in Early-Stage Breast Cancer Patients at Risk for Lymphedema. Ann Surg Oncol. 2015;22 Suppl 3:S370-5.

Blaney JM, McCollum G, Lorimer J, et al. Prospective surveillance of breast cancer-related lymphoedema in the first-year post-surgery: feasibility and comparison of screening measures. Support Care Cancer. 2015;23(6):1549-59.

Boccardo FM, Ansaldi F, Bellini C, et al. Prospective evaluation of a prevention protocol for lymphedema following surgery for breast cancer. Lymphology. 2009;41(1):1-9.

Cornish BH, Chapman M, Hirst C, et al. Early diagnosis of lymphedema using multiple frequency bioimpedance. Lymphology. 2001;34(1):2-11.

Czerniec SA, Ward LC, Refshauge KM, et al. Assessment of breast cancer-related arm lymphedema: comparison of physical measurement methods and self-report. Cancer Invest. 2010;28(1):54-62.

Hayes S, Janda M, Cornish B, et al. Lymphedema secondary to breast cancer: how choice of measure influences diagnosis, prevalaence, and identifiable risk factors. Lymphology. 2008;41(1):18-28.

Laidley A, Anglin B. The Impact of L-Dex(®) Measurements in Assessing Breast Cancer-Related Lymphedema as Part of Routine Clinical Practice. Front Oncol. 2016;6:192.

Mehrara, B. Clinical features and diagnosis of peripheral lymphedema. 06/11/2021. Up to Date. [UpToDate Web site]. http://www.uptodate.com/home/index.html. [via subscription only]. Accessed May 18, 2022.

Mehrara, B. Clinical staging and conservative management of peripheral lymphedema. 04/04/2022. Up to Date. [UpToDate Web site]. http://www.uptodate.com/home/index.html. [via subscription only]. Accessed May 18, 2022.

Oremus M, Walker K, Dayes I, et al. Diagnosis and treatment of secondary lymphedema. Agency for Healthcare Research and Quality (AHRQ) [technology assessment]. Available at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id66aTA.pdf. Accessed May 19, 2022.

Ridner SH, Dietrich MS, Cowher MS, et al. A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement for the Prevention of Lymphedema Following Treatment for Breast Cancer: Interim Analysis. Ann Surg Oncol. Oct 2019; 26(10): 3250-3259.

Shah C, Arthur DW, Wazer D, et al. The impact of early detection and intervention of breast cancer-related lymphedema: a systematic review. Cancer Med. 2016;5(6):1154-62.

Smoot BJ, Wong JF, Dodd MJ. Comparison of diagnostic accuracy of clinical measures of breast cancer-related lymphedema: area under the curve. Arch Phys Med Rehabil. 2011; 92(4):603-10.

Soran A, Ozmen T, McGuire KP, et al. The importance of detection of subclinical lymphedema for the prevention of breast cancer-related clinical lymphedema after axillary lymph node dissection; a prospective observational study. Lymphat Res Biol. 2014;12(4):289-94.

Stout Gergich NL, Pfalzer LA, McGarvey C, et al. Pre-operative assessment enables the early diagnosis and successful treatment of lymphedema. Cancer. 2008;112(12):2809-2819.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. IMP XCA with lymphodema analysis PC software. 510(k) summary. [FDA Web site]. 03/30/07. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf5/K050415.pdf. Accessed May 18, 2022.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health.
Impedimed LDex U400. 510(k) summary. [FDA Web site]. 10/03/08. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf8/K080825.pdf. Accessed May 18, 2022.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health.
SOZO. 510(k) summary. [FDA Web site]. 08/11/17. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172122.pdf. Accessed May 18, 2022.

Vicini F, Shah C, Lyden M, et al. Bioelectrical impedance for detecting and monitoring patients for the development of upper limb lymphedema in the clinic. Clin Breast Cancer. 2012; 12(2):133-7.

Ward LC, Dylke E, Czerniec S, et al. Confirmation of the reference impedance ratios used for assessment of breast cancer-related lymphedema by bioelectrical impedance spectroscopy. Lymphat Res Biol. 2011; 9(1):47-51.

Warren AG, Janz BA, Slavin SA, et al. The use of bioimpedance analysis to evaluate lymphedema. Ann Plast Surg. 2007;58(5):541-543.

Coding

CPT Procedure Code Number(s)

TO REPORT BIOIMPEDANCE FOR THE DETECTION OF LYMPHEDEMA, USE THE FOLLOWING CODE:

93702

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

N/A

HCPCS Level II Code Number(s)

N/A

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA07.062:

09/20/2023	This policy has been reissued in accordance with the Company's annual review process.
06/15/2022	This policy has been reissued in accordance with the Company's annual review proces.
06/16/2021	This policy has been reissued in accordance with the Company's annual review process.
03/25/2020	This policy has been reissued in accordance with the Company's annual review process.
12/04/2019	This policy has been reissued in accordance with the Company's annual review process.
06/06/2018	The policy has been reviewed and reissued to communicate the Company’s continuing position on bioimpedance for the detection of Lymphedema.
06/07/2017	This policy has been reissued in accordance with the Company's annual review process.
08/17/2016	The policy has been reviewed and reissued to communicate the Company’s continuing position on Bioimpedance for the Detection of Lymphedema.
04/01/2015	The policy has been reviewed and reissued to communicate the Company’s continuing position on Bioimpedance for the Detection of Lymphedema.
01/01/2015	This is a new policy.

Version Effective Date:

12/28/2014

Version Issued Date: