Latest Review Date:  September 2024

Category:  Surgical      

Note: Coverage may be subject to legislative mandates, including but not limited to the following, which apply prior to the policy statements:

• Federal Women's Health and Cancer Rights Act (WHCRA)

In accordance with the mandate listed above, Lymphatic physiologic microsurgery is covered when used to treat lymphedema resulting from a mastectomy and ordered by the individual’s treating physician.

POLICY:

Lymphatic physiologic microsurgery (including, but not limited to, lymphatico-lymphatic bypass, lymphovenous bypass, lymphaticovenous anastomosis, autologous lymph node transplantation, and vascularized lymph node transfer), is considered investigational for all indications.

DESCRIPTION OF PROCEDURE OR SERVICE:

Surgery and radiotherapy for breast cancer can lead to lymphedema and are some of the most common causes of secondary lymphedema. There is no cure for lymphedema. However, physiologic microsurgical techniques such as lymphaticovenular anastomosis or vascularized lymph node transfer have been developed that may improve lymphatic circulation thereby decreasing symptoms and risk of infection. This review focuses on physiologic microsurgical interventions and will not consider reductive (also known as excisional or ablative) surgical interventions such as liposuction.

Lymphedema

Lymphedema is an accumulation of fluid due to disruption of lymphatic drainage. 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 is one of the most common causes of secondary lymphedema.

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 magnetic resonance imaging (MRI), computed tomography (CT), ultrasound, or lymphoscintigraphy, may be used to differentiate lymphedema from others causes of edema in diagnostically challenging cases.

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

Table 1. Recommendations for Staging Lymphedema

Breast Cancer−Related Lymphedema

Breast cancer treatment is one of the most common causes of secondary lymphedema. Both the surgical removal of lymph nodes and radiotherapy are associated with development of  lymphedema in individuals with breast cancer.

In a systematic review of 72 studies (N=29,612 women), DiSipio et al (2013) reported that approximately 1 in 5 women who survive breast cancer will develop arm lymphedema. Reviewers reported that risk factors for development of lymphedema that had a strong level of evidence were extensive surgery (i.e., axillary-lymph-node dissection, greater number of lymph nodes dissected, mastectomy) and being overweight or obese. The incidence of breast cancer-related lymphedema was found by DiSipio et al as well as other authors to be up to 30% at 3 years after treatment.

Management and Treatment

Early and ongoing treatment of lymphedema is necessary. 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 (MLD) is a light pressure massage performed by trained physical therapists or by 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 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-MLD in individuals who have difficulty performing self-MLD. In individuals with more advanced lymphedema after fat deposition and tissue fibrosis has occurred, palliative surgery using reductive techniques may be performed.

KEY POINTS:

This evidence review was created with a literature search of the PubMed database performed through July 24, 2024.

SUMMARY OF EVIDENCE:

For individuals who have breast cancer-related secondary lymphedema who receive physiologic microsurgery to treat lymphedema along with continued conservative therapy, the evidence includes randomized controlled trials (RCTs),observational studies, and systematic reviews. Relevant outcomes are symptoms, morbid events, functional outcomes, health status measures, quality of life, resource utilization, and treatment-related morbidity. Several physiologic microsurgeries have been developed; examples include lymphaticovenular anastomosis and vascularized lymph node transfer (VLNT). An ongoing RCT of lymphaticovenular anastomosis was identified, but analyses of comparative outcomes between groups are limited at this time. One RCT of VLNT with 36 participants has been conducted. Systematic reviews have indicated that the preponderance of the available evidence comes from single-arm clinical series from individual institutions. Surgical technique, outcomes metrics, and follow-up time have varied across these studies. These types of studies might be used for preliminary estimates of the amount of volume reduction expected from surgery, the durability of the reduction in volume, and the rates of adverse events. However, these studies are not adequate for determining the comparative efficacy of physiologic microsurgery versus conservative treatment or decongestive therapy, or the comparative efficacy of different microsurgery techniques. Randomized controlled trials are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who are undergoing lymphadenectomy for breast cancer who receive physiologic microsurgery to prevent lymphedema, the evidence includes a RCT, an ongoing RCT, observational studies, and systematic reviews. Relevant outcomes are symptoms, change in disease status, morbid events, quality of life, and treatment-related morbidity. Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) is a preventive lymphaticovenular anastomosis performed during nodal dissection. One RCT including 46 women has been conducted. The trial reported that lymphedema developed in 4% of women in the LYMPHA group and 30% in the control group by 18 months of follow-up. However, because the cumulative incidence of lymphedema after breast cancer treatment approximates 30% at 3 years, longer follow-up is needed to assess the durability of the procedure. The trial methods of randomization and allocation concealment were not described and there was no blinding, potentially introducing bias. The remaining evidence consists of uncontrolled studies and systematic reviews of these studies. An ongoing RCT indicated improved lymphedema at 24 months (n=40) with immediate lymphatic reconstruction compared with controls (9.5% vs. 32%; p=.014), but conclusions based on this RCT are pending final analysis. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

PRACTICE GUIDELINES AND POSITION STATEMENTS:

American Association of Plastic Surgeons

The American Association of Plastic Surgeons sponsored a conference to create consensus statements and recommendations for surgical treatment and prevention of upper and lower extremity lymphedema. The recommendations were based on the results of a systematic review and meta-analysis. The relevant recommendations include:

"There is evidence to support that lymphovenous anastomosis can be effective in reducing severity of lymphedema (grade 1C). There is evidence to support that vascular lymph node transplantation can be effective in reducing severity of lymphedema(grade 1B). Currently, there is no consensus on which procedure (lymphovenous bypass versus vascular lymph node transplantation) is more effective (grade 2C). A few studies show that prophylactic lymphovenous bypass in patients undergoing extremity lymphadenectomy may reduce the incidence of lymphedema (grade 1B). More studies with longer follow-up are required to confirm this benefit."

American Society of Breast Surgeons

The American Society of Breast Surgeons published recommendations from an expert panel on preventive and therapeutic options for breast cancer-related lymphedema in 2017. The document stated that "the Panel agrees that LVA [lymphaticovenular anastomosis] and VLNT [vascularized lymph node transfer] may be effective for early secondary breast cancer-related lymphedema."

International Society of Lymphology

International Society of Lymphology published an updated consensus document on the diagnosis and treatment of peripheral lymphedema in 2020.  The document stated the following on lymphaticovenous (or lymphovenous) anastomoses (LVA):

"LVA are currently in use at multiple centers around the world. These procedures have undergone confirmation of long-term patency (in some cases more than 25 years) and some demonstration of improved lymphatic transport (by objective physiologic measurements of long-term efficacy). Multiple lymphatic-venous anastomoses in a single surgical site, with both the superficial and deep lymphatics, allow the creation of a positive pressure gradient (lymphatic-venous) and evade the phenomenon of gravitational reflux without interrupting the distal peripheral superficial lymphatic pathways. Some centers particularly in areas of endemic filariasis also practice lymph nodal-venous shunts as a derivative method. Multiple centers are using LVA (LYMPHA) as a preventative measure in high risk patients."

National Comprehensive Cancer Network

The National Comprehensive Cancer Network (NCCN) published recommendations on management of lymphedema as part of its guideline on survivorship; however, it does not discuss physiologic microsurgical techniques. The guideline states that high-level evidence in support of treatments for lymphedema are lacking. In addition, the NCCN guideline on breast cancer does not give recommendations on use of physiological microsurgical techniques for preventing or treating lymphedema.

National Lymphedema Network

The National Lymphedema Network published a position paper on the diagnosis and treatment of lymphedema in 2011. The paper provided the following statements, although notably, the document has been retracted and the Network is currently in the process of drafting a new position statement:

"Microsurgical and supramicrosurgical (much smaller vessels) techniques have been developed to move lymph vessels to congested areas to try to improve lymphatic drainage. Surgeries involve connecting lymph vessels and veins, lymph nodes and veins, or lymph vessels to lymph vessels. Reductions in limb volume have been reported and a number of preliminary studies have been done, but there are no long-term studies of the effectiveness of these techniques."

An update of this position paper is in development as of July 2024.

U.S. Preventive Services Task Force Recommendations

No U.S. Preventive Services Task Force recommendations for prevention of lymphedema have been identified.

KEY WORDS:

Lymphedema, microsurgery, lymphatico-lymphatic bypass, lymphovenous bypass, lymphaticovenous anastomosis, autologous lymph node transplantation, vascularized lymph node transfer, VLNT, LVA, WHCRA, Women's Health and Cancer Rights Act

APPROVED BY GOVERNING BODIES:

Physiologic microsurgery for lymphedema is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. 

CURRENT CODING: 

CPT codes:

REFERENCES:

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2. Armer JM. The problem of post-breast cancer lymphedema: impact and measurement issues. Cancer Invest. Mar 2005; 23(1):76-83.
3. Armer JM, Stewart BR. A comparison of four diagnostic criteria for lymphedema in a post-breast cancer population. Lymphat Res Biol. Dec 2005; 3(4):208-217.
4. Asdourian MS, Skolny MN, Brunelle C, et al. Precautions for breast cancer-related lymphoedema: risk from air travel, ipsilateral arm blood pressure measurements, skin puncture, extreme temperatures, and cellulitis. Lancet Oncol. Sep 2016; 17(9): e392-405.
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6. Carl HM, Walia G, Bello R, et al. Systematic review of the surgical treatment of extremity lymphedema. J Reconstr Microsurg. Jul 2017; 33(6):412-425.
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11. Coriddi M, Dayan J, Sobti N, et al. Systematic Review of Patient-Reported Outcomes following Surgical Treatment of Lymphedema. Cancers (Basel). Feb 29 2020; 12(3).
12. Coriddi M, Dayan J, Bloomfield E, et al. Efficacy of Immediate Lymphatic Reconstruction to Decrease Incidence of Breast Cancer-related Lymphedema: Preliminary Results of Randomized Controlled Trial. Ann Surg. Oct 01 2023; 278(4): 630-637.
13. Cornelissen AJM, Beugels J, Ewalds L, et al. The effect of lymphaticovenous anastomosis in breast cancer-related lymphedema: a review of the literature. Lymphat Res Biol. Jan 22 2018.
14. Dean LT, Kumar A, Kim T, et al. Race or Resource? BMI, Race, and Other Social Factors as Risk Factors for Interlimb Differences among Overweight Breast Cancer Survivors with Lymphedema. J Obes. 2016; 2016: 8241710.
15. Demiri E, Dionyssiou D, Tsimponis A, et al. Donor-site lymphedema following lymph node transfer for breast cancer-related lymphedema: a systematic review of the literature. Lymphat Res Biol. Feb 2018; 16(1):2-8.
16. Dionyssiou D, Demiri E, Tsimponis A, et al. A randomized control study of treating secondary stage II breast cancer-related lymphoedema with free lymph node transfer. Breast Cancer Res Treat. Feb 2016; 156(1):73-79.
17. DiSipio T, Rye S, Newman B, et al. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. May 2013; 14(6):500-515.
18. Drobot A, Bez M, Abu Shakra I, et al. Microsurgery for management of primary and secondary lymphedema: First experience in Israel. J Vasc Surg Venous Lymphat Disord. May 21 2020.
19. Drobot A, Bez M, Abu Shakra I, et al. Microsurgery for management of primary and secondary lymphedema. J Vasc Surg Venous Lymphat Disord. Jan 2021; 9(1): 226-233.e1.
20. Executive Committee of the International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2020 Consensus Document of the International Society of Lymphology. Lymphology. 2020; 53(1): 3-19.
21. Forte AJ, Cinotto G, Boczar D, et al. Omental Lymph Node Transfer for Lymphedema Patients: A Systematic Review. Cureus. Nov 25 2019; 11(11): e6227.
22. Gennaro P, Gabriele G, Salini C, et al. Our supramicrosurgical experience of lymphaticovenular anastomosis in lymphoedema patients to prevent cellulitis. Eur Rev Med Pharmacol Sci. Feb 2017; 21(4):674-679.
23. Gebruers N, Tjalma WA. Clinical feasibility of axillary reverse mapping and its influence on breast cancer related lymphedema: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2016;200:117-122.
24. Hahamoff M, Gupta N, Munoz D, et al. A lymphedema surveillance program for breast cancer patients reveals the promise of surgical prevention. J Surg Res. Feb 1 2018.
25. Han JW, Seo YJ, Choi JE, et al. The efficacy of arm node preserving surgery using axillary reverse mapping for preventing lymphedema in patients with breast cancer. J Breast Cancer. Mar 2012; 15(1): 91-7.
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29. Jonis YMJ, Wolfs JAGN, Hummelink S, et al. The 6 month interim analysis of a randomized controlled trial assessing the quality of life in patients with breast cancer related lymphedema undergoing lymphaticovenous anastomosis vs. conservative therapy. Sci Rep. Jan 26 2024; 14(1): 2238.
30. Jorgensen MG, Toyserkani NM, Sorensen JA. The effect of prophylactic lymphovenous anastomosis and shunts for preventing cancer-related lymphedema: a systematic review and meta-analysis. Microsurgery. Mar 28 2017.
31. Leung N, Furniss D, Giele H. Modern surgical management of breast cancer therapy related upper limb and breast lymphoedema. Maturitas. Apr 2015; 80(4):384-390.
32.  Li Y, Dong R, Li Z, et al. Intra-abdominal vascularized lymph node transfer for treatment of lymphedema: A systematic literature review and meta-analysis. Microsurgery. Nov 2021; 41(8): 802-815.
33. Ma X, Wen S, Liu B, et al. Relationship between Upper Extremity Lymphatic Drainage and Sentinel Lymph Nodes in Patients with Breast Cancer. J Oncol. 2019; 2019: 8637895.
34. McLaughlin SA, DeSnyder SM, Klimberg S, et al. Considerations for Clinicians in the Diagnosis, Prevention, and Treatment of Breast Cancer-Related Lymphedema, Recommendations from an Expert Panel: Part 2: Preventive and Therapeutic Options. Ann Surg Oncol. Oct 2017; 24(10): 2827-2835.
35. McLaughlin SA, Stout NL, Schaverien MV. Avoiding the Swell: Advances in Lymphedema Prevention, Detection, and Management. Am Soc Clin Oncol Educ Book. Mar 2020; 40: 1-10.
36. Naoum GE, Roberts S, Brunelle CL, et al. Quantifying the Impact of Axillary Surgery and Nodal Irradiation on Breast Cancer-Related Lymphedema and Local Tumor Control: Long-Term Results From a Prospective Screening Trial. J Clin Oncol. Oct 102020; 38(29): 3430-3438.
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43. Nguyen AT, Suami H, Hanasono MM, et al. Long-term outcomes of the minimally invasive free vascularized omental lymphatic flap for the treatment of lymphedema. J Surg Oncol. Jan 2017; 115(1):84-89.
44. Noguchi M, Yokoi M, Nakano Y. Axillary reverse mapping with indocyanine fluorescence imaging in patients with breast cancer.J Surg Oncol. Mar 01 2010; 101(3): 217-21.
45. Ozturk CN, Ozturk C, Glasgow M, et al. Free vascularized lymph node transfer for treatment of lymphedema: A systematic evidence based review. J Plast Reconstr Aesthet Surg. Sep 2016; 69(9):1234-1247.
46. Parks RM, Cheung KL. Axillary reverse mapping in N0 patients requiring sentinel lymph node biopsy - A systematic review of the literature and necessity of a randomised study. Breast. Jun 2017; 33: 57-70.
47. Petrek JA, Senie RT, Peters M, et al. Lymphedema in a cohort of breast carcinoma survivors 20 years after diagnosis. Cancer. Sep 15 2001; 92(6):1368-1377.
48. Pusic AL, Cemal Y, Albornoz C, et al. Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcome instruments and outcomes. J Cancer Surviv. Mar 2013; 7(1):83-92.
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50. Salgarello M, Mangialardi ML, Pino V, et al. A prospective evaluation of health-related quality of life following lymphaticovenular anastomosis for upper and lower extremities lymphedema. J Reconstr Microsurg. Apr 24 2018.
51. Scaglioni MF, Arvanitakis M, Chen YC, et al. Comprehensive review of vascularized lymph node transfers for lymphedema: Outcomes and complications. Microsurgery. Feb 2018; 38(2):222-229.
52. Scaglioni MF, Fontein DBY, Arvanitakis M, et al. Systematic review of lymphovenous anastomosis (LVA) for the treatment of lymphedema. Microsurgery. Nov 2017; 37(8):947-953.
53. Yue T, Zhuang D, Zhou P, et al. A prospective study to assess the feasibility of axillary reverse mapping and evaluate its effect on preventing lymphedema in breast cancer patients. Clin Breast Cancer. 2015;15(4):301-306.
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POLICY HISTORY:

Medical Policy Panel, July 2018

Medical Policy Group, September 2018

Medical Policy Administration Committee, September 2018

Available for comment September 5 through October 19, 2018

Medical Policy Panel, February 2019

Medical Policy Group, March 2019 (6): Updates to Key Points.

Medical Policy Panel, July 2019

Medical Policy Group, July 2019 (6): Updates to Key Points and Practice Guidelines.

Medical Policy Group, November 2019 (6): Updates to Title, Description, Key Points, and References. Policy Statement updated- added investigational statement, “Liposuction (lipectomy) for the treatment of lipedema is considered not medically necessary and investigational.” Added Keywords: “lipedema, lipectomy, liposuction”. Available for comment from November 15, 2019 to December 30, 2019.

Medical Policy Group, April 2020 (6): Updated coding to include 15878, 15879.

Medical Policy Panel, September 2020

Medical Policy Group, September 2020 (6): Updates to Description, Key Points, Practice Guidelines and References.

Medical Policy Group, November 2020 (6): Updates to Coding, added 15876-15877.

Medical Policy Group, January 2021 (6): Clarified Policy verbiage. No change to policy intent. 

Medical Policy Panel, September 2021

Medical Policy Group, September 2021 (6): Updates to Key Points, Practice Guidelines and References.

Medical Policy Group, October 2021 (6): All information regarding liposuction and lipedema/lymphedema removed and transferred to MP 713 Liposuction for Lipedema and Lymphedema.

Medical Policy Group, February 2022 (6): Updates to Policy statement to include non-coverage of Reverse Lymphatic Mapping. Updates to Description, Key Points, Practice Guidelines, Key Words and References. On Draft through March 18, 2022.

Medical Policy Panel, September 2022

Medical Policy Group, September 2022 (6): Updates to Description, Key Points, Practice Guidelines and References.

Medical Policy Group, November 2022 (6): Updates to Policy statement to include coverage may be subject to legislative mandates: Federal Women's Health and Cancer Rights Act (WHCRA).

Medical Policy Panel, November 2022

Medical Policy Group, November 2022 (6): Updates to Description, Key Points, Practice Guidelines, Governing Bodies, Current Coding and References to include information regarding Axillary Reverse Mapping.

Medical Policy Group, December 2022 (6): Added Key Words: WHCRA, Women's Health and Cancer Rights Act

Medical Policy Panel, September 2023

Medical Policy Group, September 2023 (6): Updates to Key Points, Practice Guidelines and Benefit Application.

Medical Policy Panel, November 2023

Medical Policy Group, December 2023 (6): Updates completed for axillary mapping to Description.

Medical Policy Group, December 2023 (6): Information regarding Axillary reverse mapping transferred to new MP 757 Axillary Mapping for Prevention of Lymphedema.

Medical Policy Panel, September 2024

Medical Policy Group, September 2024 (6): Updates to Description, Key Points, Practice Guidelines and References.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.