Cigna / ASH Medical Coverage Policies

Cigna / ASH Medical Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document may differ significantly from the standard benefit plans upon which these Cigna / ASH Medical Coverage Policies are based. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Cigna / ASH Medical Coverage Policy. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document.

Determinations in each specific instance may require consideration of:

1. the terms of the applicable benefit plan document in effect on the date of service
2. any applicable laws/regulations
3. any relevant collateral source materials including Cigna-ASH Medical Coverage Policies and
4. the specific facts of the particular situation

Cigna / ASH Medical Coverage Policies relate exclusively to the administration of health benefit plans. Cigna / ASH Medical Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. Some information in these Coverage Policies may not apply to all benefit plans administered by Cigna. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make benefit determinations. References to standard benefit plan language and benefit determinations do not apply to those clients.

Coverage for complex lymphedema therapy varies across plans. Refer to the customer’s benefit plan document for coverage details. Coverage for the treatment of lymphedema, including complex lymphedema therapy, may be governed by federal and/or state mandates. Under many benefit plans, complex lymphedema therapy is subject to the terms, conditions and limitations of the applicable benefit plan’s Short-Term Rehabilitative Therapy benefit and schedule of copayments.

If coverage is available for complex lymphedema therapy, the following conditions of coverage apply.

GUIDELINES

Medically Necessary
Complex lymphedema therapy (complete decongestive therapy) is considered medically necessary for the treatment of intractable lymphedema when ALL of the following are met:

• Documented failure of a reasonable course of conservative medical management that includes home exercises, limb elevation, and compression garments.
• The lymphedema is directly responsible for impaired functioning in the affected limb.
• Complex Lymphedema Therapy (Complete Decongestive Therapy) (CPG 157)
• The complex lymphedema therapy is prescribed by or under the supervision of an appropriate healthcare provider.

Not Medically Necessary
Vasopneumatic compression device use as part of complex lymphedema therapy is considered not medically necessary.

DESCRIPTION

Complex lymphedema therapy (CLT) is a non-invasive treatment for lymphedema with the aim to reduce and control the amount of swelling in the affected limb and restore function. Complex lymphedema therapy (CLT) is a noninvasive treatment that is a considered a standard of care for lymphedema. This method has also been referred to as complete decongestive physiotherapy (CDP), and complex decongestive therapy (CDT). The treatment aim is to reduce and control the amount of swelling in the affected limb and restore function. The objective of the technique is to redirect and enhance the flow of lymph through intact cutaneous lymphatics. Programs are generally provided on an outpatient basis in the office setting or in a lymphedema rehabilitation center or clinic (Lasinski and Boris, 2002; MacDonald, et al., 2003).

The typical CLT program consists of two phases of treatment—a treatment phase and a maintenance phase.

Phase I, the treatment phase, usually last two to four weeks. This phase consists of four components (Lawenda, et al., 2009):

• Skin and nail care: The purpose is to inspect skin, provide moisture and prevent infection.
• Manual lymph drainage (MLD): This is a light, massage-like technique that is performed for 30-60 minutes and is used to stimulate residual lymphatic vessels to carry excess fluid from the affected extremity.
• Compression bandaging: This involves wrapping multi-layered bandages around affected limb.
• Therapeutic exercise: This includes movement of the limb through a range of motion with bandaging in place.

Most patients will be able to progress to a home-based, self-managed program after an initial in-office program of 1–2 weeks. Instruction in self-management should begin in the first week of therapy. Both patients and family are taught bandaging and exercise techniques, as well as the essentials of skin and nail care. After the initial one- to two-week program, patients should be re-evaluated to determine whether continued in-office therapy is necessary or if treatment can be provided in the home.

Phase II, the maintenance phase, consists of life-long self-care to maintain the size of the limb. In this phase, the patient maintains and optimizes the results by applying the techniques learned in the treatment phase including: skin and nail care, wearing an elastic sleeve during the day, bandaging the affected limb overnight and exercises (Petrek, 2000).

Duration and Frequency

A program of complex lymphedema therapy provided 2–5 times per week for two weeks is generally considered medically necessary for the treatment of primary or secondary lymphedema, in the absence of any contraindications. Programs that go beyond a four-week period are generally considered not medically necessary.

Contraindications

Absolute contraindications to lymphedema therapy include:

• acute infections of the affected limb
• venous or arterial obstruction (deep vein thrombosis)
• active malignancy, confirmed or suspected local disease
• unwillingness or inability of the member to participate in the treatment

Relative contraindications to lymphedema therapy include:

• suspicion of deep vein thrombosis prior to starting treatment
• congestive heart failure

Complex Lymphedema Therapy (Complete Decongestive Therapy) (CPG 157)

GENERAL BACKGROUND

Lymphedema is defined as the excessive and persistent accumulation of protein rich fluid that collects in the interstitial spaces, due to an inefficiency of the lymphatic system (Szuba et al., 2002; Leal et al., 2009). Lymphedema occurs primarily as a result of malformation, underdevelopment, or acquired disruption of the lymphatic circulation (Szuba et al., 2002). Primary lymphedema is due to congenital defects of the lymphatic system, which can affect from one to as many as four limbs or other parts of the body and is considered rare (National Lymphedema Network, 2011). Secondary lymphedema is acquired and is due to an obstruction or interruption in the lymphatic circulation. Secondary lymphedema can develop as a result of surgery, radiation, infection or trauma. It is a common treatment-related side effect experienced by cancer patients. Patients that undergo surgery for breast cancer that includes node dissection or axillary radiation therapy are at high risk of developing lymphedema. Historically, lymphedema has been classified into three (3) stages based on its severity and on observation of the patient’s condition.

Stages of Lymphedema

Currently, the International Society of Lymphedema is recognizing a Stage 0 in patients, which refers to a latent or sub-clinical condition where swelling is not evident despite impaired lymph circulation. Patients often report a feeling of heaviness in the limb, however many patients are asymptomatic in the latency stage. Stage 0 may be present for months or years prior to a patient exhibiting signs and symptoms of edema.

Stage I Lymphedema

Stage I lymphedema is referred to as spontaneously reversible lymphedema and typically involves pitting edema, an increase in limb girth (usually upper extremity), and heaviness.

Stage II Lymphedema

Stage II is also known as spontaneously irreversible lymphedema and it is marked by spongy consistency of the tissue and non-pitting edema. Tissue fibrosis marks the beginning of hardening of the limbs and increased girth of extremity and is often found in Stage II.

Stage III Lymphedema

Stage III is the most advanced stage and is often referred to as lymphostatic elephantiasis. During Stage III the swelling is irreversible with tissue being fibrotic and unresponsive including patients who present with very large limb(s) size. It is associated with a significant increase in the severity of the fibrotic response, tissue volume, and other skin changes such as papillomas, cysts, fistulas, and hyperkeratosis.

With regards to Stage 0, the literature is insufficient to conclude that the use of Complex Decongestive Therapy (CDT) is either clinically effective or ineffective in the treatment of subclinical or latent stage of breast cancer related lymphedema.

CDT Treatment and Alternatives

The best practice or gold standard for lymphedema treatment is considered complex decongestive therapy (CDT), also known as complex lymphedema therapy (CLT). CDT is a noninvasive treatment and consists of four basic components as follows: skin and nail care, manual lymph drainage (MLD), followed by bandaging/compression, education, and exercise. The goal of CDT is to reduce and control the amount of swelling in the affected limb and restore function.

A treatment option that may be used to manage secondary lymphedema is intermittent pneumatic compressions (IPC) (vasopneumatic compression) which is added to CDT. However, evidence does not support the addition of IPC to CDT or within any treatment plan.

Low-level laser therapy (LLLT) is another treatment option that has been studied as a treatment when used in conjunction with other standard lymphedema treatments. However, low-level laser is currently considered experimental, investigational and/or unproven.

Exercise demonstrates improvements in function and QoL, but not in limb reduction. The goal of all conservative treatment is to reduce and control the amount of swelling in the affected limb and restore function.