Description
Lymphatic fluid is a clear fluid that travels throughout the body. Its job is to remove wastes and bacteria from tissue. Lymphedema is swelling when too much lymphatic fluid accumulates in any part of the body. Lymphedema can be a result of certain surgeries or other procedures that remove or affect lymph node drainage. Lymphedema occurs because there are fewer natural channels for the fluid to move through. Typical treatment calls for raising the affected arm, massaging the area, or using pumps that apply light pressure. Certain surgeries are now being studied. These surgeries call for rerouting the flow of lymphatic fluid by connecting lymph vessels to veins, lymph nodes and veins, or lymph vessels to other lymph vessels. Other surgeries try to reduce swelling by moving other tissue into the surgical area or using suction to remove excess fat and proteins. Many of these surgeries are investigational (unproven). More studies are needed to see how well they work over the long term.

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

Policy  
Lipectomy or liposuction for the treatment of lymphedema or lipedema may be considered MEDICALLY NECESSARY when the following criteria are met:

• There is documentation of significant physical functional impairment (e.g., difficulty ambulating or performing activities of daily living).
• The individual has not responded to at least 3 consecutive months of optimal medical management (such as conservative treatment with compression garments and manual lymph drainage).
• The plan of care postoperatively is to continue to wear compression garments as instructed to maintain the benefits of treatment.
• For the diagnosis of lipedema, the individual has all of the following clinical exam findings: (see Table 1)
  • Bilateral symmetric adiposity in the extremities
  • Non-pitting edema
  • Tissue in affected areas is soft to palpation
  • Tissue in affected areas is tender to palpation
• Submission of photographs documents the affected extremities requested for treatment and are consistent with the diagnosis of lipedema or lymphedema.

The following surgical treatments to treat lymphedema (e.g., upper or lower extremities or genitalia) are investigational/unproven and therefore considered NOT MEDICALLY NECESSARY:

• Lymphatic physiologic microsurgery
  • Lymphatico-lymphatic bypass
  • Lymphovenous bypass
  • Lymphaticovenous anastomosis
  • Autologous lymph node transplantation
  • Vascularized lymph node transfer
• Tissue transfer (e.g., omental or mesenteric flap)
• Reductive/ablative techniques
  • Direct excision

Lymphatic physiologic microsurgery performed during nodal dissection or breast reconstruction to prevent lymphedema (including, but not limited to, the Lymphatic Microsurgical Preventing Healing Approach) in individuals who are being treated for breast cancer is investigational/unproven and therefore considered NOT MEDICALLY NECESSARY.

Reverse lymphatic mapping used during lymphatic surgical or liposuction procedures is investigational/unproven and therefore considered NOT MEDICALLY NECESSARY.

The patient’s medical records submitted for review for all conditions should document that MEDICALLY NECESSARY criteria are met. The record should include the following:

• Office visit notes that contain the relevant history and physical (with the specific surgical procedure requested, any physical functional impairment noted, medical management tried, post-op plan of care for use of compression garments)
• If request is for the treatment of lipedema, all of the following clinical exam findings are documented: bilateral symmetric adiposity in the extremities, non-pitting edema, tissue in affected areas is soft to palpation, and tissue in affected areas is tender to palpation
• Photographs document the affected extremities requested for treatment and are consistent with the diagnosis of lipedema or lymphedema

Rationale
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. 

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).

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, computed tomography, ultrasound, or lymphoscintigraphy, may be used to differentiate lymphedema from other causes of edema in diagnostically challenging cases. 

Table 2 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.1 

Table 2. 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 patients 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.² 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.^2,3,4 

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. Patients 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 patients, 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 patients who have difficulty performing self-manual lymphatic drainage. In patients with more advanced lymphedema after fat deposition and tissue fibrosis has occurred, palliative surgery using reductive techniques such as liposuction may be performed. 

Table 3. Physiologic Microsurgical Interventions for Lymphedema 

Reductive (Excisional or Ablative) Surgical Interventions
Reductive techniques remove fibrous, fatty tissue that has developed from sustained lymphatic fluid stasis. Reductive interventions include direct excision and liposuction procedures.

• Direct excision: There are several direct excision procedures for the treatment of extremity and genital lymphedema. Subcutaneous tissue is excised along with the skin and soft tissues to attempt to reduce the volume of the affected area. The resulting defects are then covered with tissue flaps or skin grafts. Wound healing complications and infections have been reported as side effects of this type of intervention along with sexual dysfunction, decreased sensation and urethral injury when performed on the genitalia.³⁵
• Liposuction: Fibrous, fatty issue is removed through multiple small incisions of the affected extremity via a cannula attached to a powered suction device. Compression garments are worn postoperatively and may be required indefinitely to maintain the adipose tissue volume reduction obtained with this procedure. This technique is intended for patients with end-stage lymphedema who have not responded to conservative treatments. Minor complications such as occasional paresthesias and wound healing are reported with this technique.³⁵ 

Liposuction for the Treatment of Lipedema
Lipedema is a rare disorder in which increased adipose (fat) tissue builds up under the skin causing non-pitting, symmetric, bilateral swelling of the lower extremities; the upper extremities can also be affected. Hands and feet characteristically do not swell. It primarily affects women. The cause of lipedema is unknown and there is currently no curative treatment for this condition. Signs and symptoms typically present at puberty, pregnancy, or menopause. Because of this it is theorized that there is a hormonal influence on the disorder. Hereditary factors are also thought to play a role in its etiology. Lipedema is often painful and may present with bruising along with sensitivity to touch. This condition gradually worsens over time and may progress to a lipo-lymphedema due to the lymphatic load exceeding the lymphatic transport capacity. Lipedema is often misdiagnosed as obesity or lymphedema but does not generally respond to weight loss, exercise, or elevation of the limbs as do those disorders. 

Types of Lipedema 

• Type 1: Pelvis, buttocks and hips (saddle bag phenomenon) 
• Type 2: Buttocks to knees with formation of folds of fat around the inner side of the knee 
• Type 3: Buttocks to ankles 
• Type 4: Arms 
• Type 5: Isolated lower leg 

Stages of Lipedema 

• Stage 1: Even and smooth skin surface with enlarged subcutaneous fat tissue 
• Stage 2: Uneven skin surface with nodular elevations and indentations of subcutaneous fat and lipomas 
• Stage 3: Large deforming growths of nodular fat or hanging flaps of the thighs and around the knees 
• Stage 4: Large overhangs of tissue, dysfunctional lymphatics with lipedema and lipolyphedema 

Treatment is aimed at relieving the symptoms. Conservative care with combined decongestive therapy (manual lymphatic drainage and compression garments) is the mainstay treatment of choice. If there is an inadequate response to conservative or supportive measures, tumescent liposuction has been proposed as the next line of treatment. Tumescent liposuction is a technique whereby local anesthetic, such as diluted lidocaine and epinephrine, is injected into subcutaneous fat and a vibrating cannula associated with power-assisted liposuction removes the fat. Waterjet assisted liposuction is another method of liposuction that may be used to treat lipedema. This method uses a pressurized stream of saline to dislodge the fat and more gently loosen and remove the fat cells. 

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 a randomized controlled trial (RCT), 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. No RCTs of lymphaticovenular anastomosis or similar surgeries involving the venous system were identified. One RCT of vascularized lymph node transfer 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 vs conservative treatment or decongestive therapy, or the comparative efficacy of different microsurgery techniques. RCTs are needed. The evidence is insufficient to determine the effects of the technology on health outcomes. 

For individuals who are undergoing lymphadenectomy for breast cancer who receive physiologic microsurgery to prevent lymphedema, the evidence includes an 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 (LMPHA) is a preventive lymphaticovenular anastomosis performed during nodal dissection. One RCT including 46 patients has been conducted. The trial reported that lymphedema developed in 4% of women in the Lymphatic Microsurgical Preventing Healing Approach 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 sham procedure or blinding, potentially introducing bias. The remaining evidence consists of two controlled observational studies with inadequate description of control selection and uncontrolled studies. The evidence is insufficient to determine the effects of the technology on health outcomes. 

Randomized controlled trials are needed to prove the benefits of pedicled or laparoscopic free omental lymphatic flap for the management of lymphedema. 

Reverse mapping using blue dye as a method for preserving the lymphatic drainage of the arm in breast cancer cases or indo-cyanine green as a technique to identify lymph node drainage patterns to localize lymph nodes in the surgical treatment of lymphedema are being investigated. Further studies are needed to determine the long-term outcomes of these techniques. The evidence is insufficient to determine the effects of the technology on health outcomes. 

Results of the available studies provide limited evidence that suction-assisted protein lipectomy (SAPL) for the treatment of lymphedema that fails to respond to conservative therapy due to overgrowth of adipose tissue is a safe and effective technique. The best available evidence of efficacy was obtained in nonrandomized controlled studies. Liposuction combined with compression therapy reduced lymphedema volume versus compression therapy alone. Additional controlled studies are needed to confirm that liposuction for the treatment of lymphedema is a safe and effective therapy. 

A 2019 Hayes Search and Summary on liposuction for the treatment of lipedema concludes that there is insufficient published evidence to assess the safety and health outcomes of liposuction for the treatment of lipedema. 

Despite the lack of strong evidence, clinical guidelines recommend liposuction in patients with advanced lipedema and for chronic lymphedema, as there is limited treatment available when conservative measures have failed. 

Practice Guidelines and Position Statements
Austrian Academy of Cosmetic Surgery and Aesthetic Medicine and the International Society for Dermatologic Surgery
Austrian Academy of Cosmetic Surgery and Aesthetic Medicine and the International Society for Dermatologic Surgery: Prevention of Progression of Lipedema with Liposuction Using Tumescent Local Anesthesia: Results of an International Consensus Conference. 2020. This consensus statement concludes: “Lymph-sparing liposuction using tumescent local anesthesia is currently the only effective treatment for lipedema.” 

Canadian Agency for Drugs and Technologies in Health (CADTH)
In 2019 CADTH published A Review of Clinical Effectiveness and Guidelines for Liposuction for the Treatment of Lipedema. The guideline recommends that tumescent liposuction be considered the treatment of choice for patients with an inadequate response to conservative measures. 

National Institute for Health and Care Excellence (NICE)
The National Institute for Health and Care Excellence (NICE, 2017) states that "Current evidence on the safety and efficacy of liposuction for chronic lymphoedema is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit." 

“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.”

International Society of Lymphology
The International Society of Lymphology published a consensus document on the diagnosis and treatment of peripheral lymphedema in 2016.¹ 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 20 years) and some demonstration of improved lymphatic transport (by objective physiologic measurements of long-term efficacy).

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 2017.²⁷ The document stated that "the Panel agrees that LVA and VLNT may be effective for early secondary breast cancer-related lymphedema."

U.S. Preventive Services Task Force Recommendations

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

Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this review are listed in Table 4. 

Table 4. Summary of Key Trials 

NCT: national clinical trial. 

Additional Information 
Definition of Terms 
When specific definitions are not present in a member’s plan, the following definitions will be applied.

Physical functional impairment: In this policy, physical functional impairment means either limitation from normal physical functioning or baseline level of functioning that may include, but is not limited to, problems with ambulation, mobilization, communication, respiration, eating, swallowing, vision, facial expression, skin integrity, distortion of nearby body part(s) or obstruction of an orifice. The physical functional impairment can be due to structure, congenital deformity, pain or other causes. Physical functional impairment excludes social, emotional and psychological impairments or potential impairments.

Table 1. Comparison of Findings in Lipedema, Lymphedema and Lifestyle-Induced Obesity 

Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5055019/ Accessed November 24, 2020 

References 

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65. Austrian Academy of Cosmetic Surgery and Aesthetic Medicine (AACMS) and the International Society for Dermatologic Surgery (ISDS): Prevention of Progression of Lipedema with Liposuction Using Tumescent Local Anesthesia: Results of an International Consensus Conference. 2020.
66. ECRI Institute. Hotline Response. Liposuction for Treating Lipedema. Plymouth Meeting, PA. ECRI Institute Published March 12, 2020. https://www.ecri.org/ Accessed November 24, 2020.
67. National Institute for Health and Care Excellence (NICE). Liposuction for chronic lymphoedema. [IPG588]. 2017; https://www.nice.org.uk/guidance/IPG588. Accessed November 24, 2020. 

Coding Section 

Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes, descriptions and materials are copyrighted by Centers for Medicare & Medicaid Services (CMS).

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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