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Date Printed: June 26, 2017: 01:23 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

01-91000-09

Original Effective Date: 06/15/10

Reviewed: 05/22/14

Revised: 01/01/15

Subject: Bioimpedance Devices for Detection and Management of Lymphedema

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates  

DESCRIPTION:

Secondary lymphedema may develop following surgery for breast cancer. Bioelectrical impedance is being studied as a diagnostic test for lymphedema, particularly for subclinical disease.

Secondary lymphedema of the upper extremity may develop following surgical treatment for breast cancer; it has been reported in approximately 25% to 50% of women following mastectomy. This can be a chronic, disfiguring condition. It results from lymphatic dysfunction or disruption and can be difficult to accurately diagnose and manage. One challenge is identifying the presence of clinically significant limb swelling through simple noninvasive methods. Many techniques have been used for documenting lymphedema including measuring differences in limb volume (volume displacement) and limb circumference. A number of newer techniques are being evaluated, including bioimpedance with use of bioimpedance spectroscopy (BIS) analysis, which uses resistance to electrical current in comparing the composition of fluid compartments. BIS is based on the theory that the amount of opposition to 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.

The detection of subclinical lymphedema (i.e., the early detection of lymphedema before clinical symptoms become apparent) is another area of study. Detection of subclinical lymphedema (referred to as Stage 0 lymphedema) is problematic. Subclinical disease may exist for months or years before overt edema is noted. This approach generally involves comparison of preoperative with postoperative measurements, since existing differences between upper extremities (like the effects of a dominant extremity) may obscure early, subtle differences resulting from the initial accumulation of fluid. Bioimpedance has been proposed as one diagnostic test for this condition. Those who support the approach to diagnose subclinical disease believe that early treatment of subclinical lymphedema should result in less severe chronic disease.

POSITION STATEMENT:

Devices using bioimpedance (bioelectrical impedance spectroscopy) for use in the diagnosis, surveillance, or treatment of patients with lymphedema, including use in subclinical secondary lymphedema, is considered experimental or investigational due to insufficient clinical evidence published in the peer-reviewed literature to establish efficacy for lymphedema or any other indications. There is no specific evidence that an approach to diagnosis and management of lymphedema using bioimpedance devices improves health outcomes.

BILLING/CODING INFORMATION:

Some providers may inappropriately report these services using 38792 (Injection procedure; radioactive tracer for identification of sentinel node) and 78195 (Lymphatics and lymph nodes imaging).

CPT Coding:

93702

Bioimpedance spectroscopy (BIS), extracellular fluid analysis for lymphedema assessment(s) (investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Noncovered Services (L29288) located at fcso.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Lymphedema Pumps and Devices, 09-E0000-31

OTHER:

Indexing terms for bioimpedance:

REFERENCES:

  1. Agency for Healthcare Research and Quality (AHRQ) Technology Assessment. Diagnosis and Treatment of Secondary Lymphedema (05/28/10).
  2. Ahmed RL et al. Lymphedema and Quality of Life in Breast Cancer Survivors: The Iowa Women’s Health Study. J Clin Oncol 26:5689-5696 (12/10/08).
  3. American Cancer Society. Lymphedema: What Every Woman with Breast Cancer Should Know (last revised 03/05/09).
  4. Blue Cross and Blue Shield Association Medical Policy Reference Manual. 2.01.82. Bioimpedance Devices for Detection of Lymphedema (11/14/13).
  5. Centers for Medicare and Medicaid Services (CMS). Medicare Coverage Database. MEDCAC Meeting Minutes. Lymphedema (11/18/09).
  6. ClinicalTrials.gov. Accessed 03/24/14.
  1. Czerniec SA, Ward LC, et al. Assessment of Breast Cancer-Related Arm Lymphedema – Comparison of Physical Measurement Methods and Self-Report. Cancer Investigations, 28:54-62, 2010.
  2. First Coast Service Options (Local Medicare) Local Coverage Determination (LCD) Noncovered Services (L29288) (01/29/13).
  3. Hayes SC et al. Lymphedema after Breast Cancer: Incidence, Risk Factors, and Effect on Upper Body Function. J Clin Oncol 26:3536-3542 (07/20/08).
  4. ImpediMed. Lymphedema (accessed 04/03/13).
  5. Kim L, Jeon JY, Sung IY, Jeong SY, Do JW, Kim HJ. Prediction of Treatment Outcome with Bioimpedance Measurements in Breast Cancer Related Lymphedema Patients. Ann Rehabil Med 2011; 35: 687-693.
  6. MayoClinic.com. Lymphedema (accessed 02/26/10).
  7. McLaughlin, SA et al. Prevalence of Lymphedema in Women with Breast Cancer 5 Years after Sentinel Lymph Node Biopsy or Axillary Dissection: Objective Measurements. J Clin Oncol 26:5213 – 5219 (11/10/08).
  8. Moseley et al. Reliability of Bioimpedance Spectroscopy and Tonometry after Breast Conserving Cancer Treatment. Lymphat Res Biol. 2008; 6(2):85-7.
  9. National Cancer Institute. Lymphedema (PDQ®) Health Professional Version (last modified 06/13/11).
  10. National Lymphedema Network (NLN). 18 Steps to Prevention Revised: Lymphedema Risk-Reduction Practices. 2008 (accessed 02/26/10).
  11. National Lymphedema Network (NLN). Lymphedema Insurance & Legislation Update: Jan-March, 2010.
  12. National Lymphedema Network Position Statement. Screening and Measurement for Early Detection of Breast Cancer Related Lymphedema. Updated April 2011
  13. National Lymphedema Network Supplement to NLN Position Breast Cancer Screening. Screening and Early Detection of Breast Cancer-Related Lymphedema: The Imperative. February 2012.
  14. National Lymphedema Network Position Statement. The Diagnosis and Treatment of Lymphedema. Updated February 2011
  15. Rockson et al. Bioimpedance analysis in the assessment of lymphoedema diagnosis and management. J Lymphoedema 2007, VOL 2; NUMB 1, pages 44 – 49.
  16. Shih YT et al. Incidence, Treatment Costs, and Complications of Lymphedema After Breast Cancer Among Women of Working Age: A 2-Year Follow-up Study. J Clin Oncol 27 (03/16/09).
  17. Stout NL, Gergich NL et al. Peroperative Assessment Enables the Early Diagnosis and Successful Treatment of Lymphedema. Cancer 2008; 112:2809-19. Published online 04/21/08 in Wiley InterScience.
  18. U.S. Food and Drug Administration (FDA) 510(k) summary: ImpediMed IMP XCA ExtraCellular Fluid Analysis. Accessed 04/02/13.
  19. U.S. Food and Drug Administration (FDA) 510(k) summary: The L-Dex U400. Accessed 04/15/13.
  20. Ward et al. Operational equivalence of bioimpedance indices and perometry for the assessment of unilateral arm lymphedema. Lymphat Res Biol. 2009; 7(2):81-5.
  21. Ward et al. Quantitative bioimpedance spectroscopy for the assessment of lymphoedema. Breast Cancer Res Treat. 2009 Oct; 117(3):541-7. Epub 2008 Dec 11.
  22. Warren et al. The use of bioimpedance analysis to evaluate lymphedema. Ann Plast Surg. 2007 May; 58(5):541-3.
  23. York et al. Single frequency versus bioimpedance spectroscopy for the assessment of lymphedema. Breast Cancer Res Treat. 2009 Sep; 117(1):177-82. Epub 2008 Jun 18.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 05/22/14.

GUIDELINE UPDATE INFORMATION:

06/15/10

New Medical Coverage Guideline.

01/01/11

Annual HCPCS coding update. Added code 0239T.

01/01/12

Annual HCPCS coding update: notation regarding description of 38792 is revised.

07/15/12

Scheduled review; position statement unchanged, references updated.

06/15/13

Scheduled review; position statement unchanged, Program Exceptions section updated, references updated.

06/15/14

Scheduled review; policy title revised; position statement reformatted; references updated.

01/01/15

Annual coding update: removed 0239T; added 93702.

Date Printed: June 26, 2017: 01:23 AM