Complex Decongestive Physiotherapy:

Aetna considers a course of complex decongestive physiotherapy (CDP), also called manual lymphoid drainage, medically necessary when both of the following criteria are met:

1. The member has any of the following conditions:

   1. Intractable lymphedema of the extremities, unrelieved by elevation; or
   2. One or more previous admissions to treat complications of intractable lymphedema (i.e., cellulitis, ulceration); or

   3. Evidence of ulceration due to lymphedema; and

2. The member has shown a past record of compliance and the member or his/her caregiver is capable of following the instructions associated with CDP.

Lymphedema Pumps:

Aetna considers lymphedema pumps (pneumatic compression devices) medically necessary durable medical equipment (DME) for home use for the treatment of lymphedema if the member has undergone a four-week trial of conservative therapy and the treating doctor determines that there has been no significant improvement or if significant symptoms remain after the trial. The trial of conservative therapy must include use of an appropriate compression bandage system or compression garment, exercise, and elevation of the limb. The garment may be prefabricated or custom-fabricated but must provide adequate graduated compression.

Note: For members without DME benefits, lymphedema pumps are only covered for members with arm lymphedema due to mastectomy for breast cancer who meet the criteria for a lymphedema pump stated above.*

When medical necessity criteria for a pneumatic compression device are met, a non-segmented device or segmented device without manual control of the pressure in each chamber is generally considered medically necessary to meet the clinical needs of the member.  A segmented device with manual control of the pressure in each chamber is considered medically necessary only if there is clear documentation of medical necessity in the individual case.  A segmented device with manual control of the pressure in each chamber is considered medically necessary only when there is documentation that the individual has unique characteristics that prevent satisfactory pneumatic compression treatment using a non-segmented device with a segmented appliance/sleeve or a segmented device without manual control of the pressure in each chamber.

A 2-phase lymph preparation and drainage therapy device (Flexitouch Device, Tactile Systems Technology, Minneapolis, MN) is considered equally effective to standard segmented pneumatic compression devices.  

For Aetna’s clinical policy on pneumatic compression devices for chronic venous insufficiency, see CPB 500 - Intermittent Pneumatic Compression Devices for the Legs.

Note: Although the literature suggests that the use of lymphedema pumps is commonly initiated in the hospital, there is no medical necessity for this practice unless the member has other complications of lymphedema (i.e., cellulitis) that would require hospitalization. The use of lymphedema pumps can be initiated in the clinic or in the home setting.

Static Compression Sleeves:

Aetna considers static compression sleeves (e.g., the ReidSleeve, ArmAssist) to be medically necessary supplies for members with intractable lymphedema of the arms. Note: For members whose plans exclude coverage of supplies, static compression sleeves are only covered for intractable lymphedema of the arms due to mastectomy for breast cancer.*  See also CPB 482 - Compression Garments for the Legs.

Static Compression Garments for the Trunk:

Aetna considers static compression garments for the trunk experimental and investigational. There is a lack of peer-reviewed published literature evaluating the clinical utility of static compression garments for truncal lymphedema

Microsurgical Lymphaticovenous Anastomosis:

Aetna considers microsurgical lymphaticovenous anastomosis experimental and investigational for the treatment of members with chronic obstructive lymphedema because the long-term effectiveness of this procedure has not been established by the peer-reviewed medical literature.

*Note: HR 4328 (Public Law 105-277) requires individual and employer group health plans (including indemnity, PPO, POS and HMOs), that provide medical and surgical benefits with respect to a mastectomy, to provide coverage for lymphedema treatment in a manner determined in consultation with the attending physician and the member for a participant or beneficiary who is receiving benefits for a mastectomy and who elects breast reconstruction after the mastectomy. Therapy is subject to annual deductibles and co-insurance provisions for physical therapy. Therapy is not subject to visit limitation provisions for physical therapy.

Lymphedema refers to edema (i.e. swelling) due to inadequate lymphatic circulation related to either: (i) defective development of the lymphatics (primary lymphedema); or  (ii) destruction or obliteration of the lymphatic system (secondary lymphedema) due to either trauma, wounds, surgery, radiation therapy, or infection with a tropical filarial parasite.  Primary lymphedema typically involves the lower extremities and typically afflicts females.  When it arises at birth it is called lymphedema congenita, before the age of 35 it is called lymphedema praecox, and when arising later in life it is called lymphedema tarda.  Secondary lymphedema occurs most commonly after lymph node dissections.  For example, 10 to 20% of women with breast cancer who have undergone axillary dissection will experience lymphedema.  Leg edema can result after groin dissection, most typically for melanoma.  Lymphedema results in a feeling of heaviness, aching or tightness.  In severe cases, mobility can be impaired.  Development of angiosarcoma, know as the Stewart-Trewes syndrome, is a very rare complication of  long standing severe lymphedema.

The severity of lymphedema can be graded as follows:

Grade I: Mild and intermittent lymphedema which pits easily

Grade II: Moderate and persistent lymphedema, no pitting, unrelieved by elevation

Grade III: Fibrosclerotic lymphedema (elephantiasis)

Conservative treatment of lymphedema focuses on a combination of physical therapies: elevation of the arm or leg, manual physical therapy, wearing of various types of compression stockings/bandages, or pneumatic pumps.  

The use of elastic stockings is considered a valuable component of lymphedema therapy, and appears to be critical to the long term success of treatment.  Compliance with elastic stocking may be problematic since they are frequently hot, uncomfortable, and considered unsightly by some.  Lack of compliance may result in requests for further treatment, such as pneumatic pumps or complex decongestive physiotherapy.  However, elastic garments are a component of all treatments of lymphedema and compliance has a major impact on the success of any treatment of lymphedema.

Pneumatic pumps can consist either of static unicompartmental pumps where an equal amount of pressure is applied throughout the edematous limb, or a sequential pump which essentially attempts to “wring out” the edema by graded compression from distal to proximal.  Due to the short cycles of pressure, higher pressures can be applied compared to the static pumps.  Pressures higher than the systolic blood pressure are avoided; pressures up to 80 to 90 mm Hg are typical.  At this point sequential pumps (such as the Lymphapress or the Wright linear sequential pump) appear to be more commonly used than static pumps. The Lymphapress device is composed of a series of overlapping cells that apply a sequential pattern of compression moving distally to proximally along the affected limb.  Using this strategy, higher levels of pressure can be applied compared to other unicompartmental devices which apply the same degree of pressure along the entire limb. The Lymphapress device seems to be effective in acutely decreasing lymphedema, and many patients have purchased this device for home use.

The Flexitouch Device (Tactile Systems Technology, Minneapolis, MN) is a 2-phase lymph preparation and drainage therapy device. The device consists of an electronic controller unit and garments which are worn on the trunk and upper and lower affected extremities and connected to the controller unit by tubing harnesses. The garment consists of 32 inflatable chambers that sequentially inflate and deflate at 1 to 3 second intervals, according to one of the 13 pre-programmed treatment patterns selected.  Chamber pressure and treatment times can be adjusted.  The manufacturer states that device’s sequential action evacuates lymph from the trunk and extremities and drains it into the venous system.  The garments are made from stretch material and are fitted with Velcro enclosures, so custom fitting of garments is not required.  There are no published studies comparing the effectiveness of this 2-phase lymph preparation and drainage therapy device to standard segmented pneumatic compression devices.

Drug therapy with benzopyrone can also result in slow reduction of lymphedema. This drug is a protoeolytic agent which acts by activating macrophages, which then break down the protein-rich lymphedema fluid, thus decreasing its viscosity and thereby facilitating its flow.

A technique developed in Germany, complex decongestive physiotherapy (CDP), has been introduced in the United States.  CDP is most frequently offered in specialized clinics. Patients attend the clinics for about 4 hours a day for one to 4 weeks.  CDP consists of four basic components as follows:

1. Meticulous skin and nail care. The protein rich lymphedema fluid is highly susceptible to infection which can then further damage the lymphatics resulting in a vicious cycle.  Thus meticulous skin and nail care is required.  Emollients are often used to prevent drying and cracking of the skin and all fungal infections must be treated promptly.
2. Manual lymphatic drainage (MLD). This massage technique seems to be the unique component of this multidisciplinary approach and is based on the concept that the lymphatic system is subdivided into individual lymphotomes which communicate through collateral channels.  The idea behind MLD is to increase the collateral circulation between these lymphotomes, such that the lymphedema fluid can be shunted from an inadequately draining lymphotome into a normal one.  Thus, unlike other massage techniques, MLD begins with massage of the contralateral truncal lymphotome and then progresses toward the edematous extremity.  Theoretically, in this way the collateral circulation is opened and dilated and the lymphatic drainage is “decongested.”  There is no specific description of the technique of MLD, or theories as to how this technique can open and dilate collateral channels.Patients enrolled in the CDP clinic may undergo 1-2 such MLD sessions (about 45 minutes each) each day.
3. Bandaging. After the MLD session, the lymphedematous limb is wrapped with a pure cotton, minimally elastic bandages in order to provide adequate tissue pressure which in turn prevents reaccumulation of lymphedema.
4. Remedial Exercises. These exercises are performed while wearing the bandages, and thus the muscles contract against a firm external force, further stimulating lymph flow.

During the clinical sessions the patients receive additional counseling in various aspects of self management, such as skin care, nutrition, weight control, etc.  Prior to discharge from the clinic, the patient is fitted with an elastic support garment.  It is recommended that this garment be worn as much as possible, and even at night.  Some clinics may recommend wearing the bandages at night, and the compressive garment during the day.  The use of these garments can be gradually reduced as the patient improves, however, typically, the patient will need to continue wearing the compressive garment at least part time. An initial course of CDP may require 30 days, or in the case of lower extremity care, 45 days.

No conservative treatment is entirely curative and all require a committed physical therapy team and a committed and compliant patient.

Surgery has been used in patients with severe lymphedema.  Excisional surgical procedures involve resection of the redundant tissue that may develop in long-standing severe lymphedema and elephantiasis.

Physiologic surgical procedures attempt to provide or enhance lymphatic drainage with either anastomoses between lymphatic systems (i.e. linking subcutaneous tissues with the deep lymphatics), creating lymphovenous anastomoses or creation of artificial lymph channels.  These surgical techniques are controversial and rarely used.

Pneumatic Compression Devices for the Legs

Aetna considers full- or half-leg pneumatic compression devices for home use medically necessary durable medical equipment (DME) for the treatment of chronic venous insufficiency of the legs of members who have venous stasis ulcers that have failed to heal after a 6-month trial of conservative therapy directed by the treating physician. The trial of conservative therapy must include a compression bandage system or compression garment, appropriate dressings for the wound, exercise, and elevation of the limb.

When a pneumatic compression device is determined to be medically necessary, a non-segmented device or segmented device without manual control of the pressure in each chamber is generally considered adequate to meet the clinical needs of the member. A segmented device with manual control of the pressure in each chamber is considered medically necessary only if there is clear documentation of medical necessity in the individual case. A segmented device with manual control of the pressure in each chamber is considered medically necessary only when there is documentation that the individual has unique characteristics that prevent satisfactory pneumatic compression treatment using a non-segmented device with a segmented appliance/sleeve or a segmented device without manual control of the pressure in each chamber.

Aetna considers the use of pneumatic compression devices experimental and investigational for the treatment of peripheral arterial occlusive disease/arterial insufficiency and for all other indications because their effectiveness for these indications has not been established.

Intermittent Pneumatic Compression Boots

Aetna considers intermittent pneumatic compression boots medically necessary DME to stimulate circulation and reduce the chances of deep venous thromboses for members who are unable to walk due to trauma, orthopedic surgery, neurosurgery or other circumstances preventing ambulation.

Aetna considers intermittent pneumatic compression boots experimental and investigational for treatment of chronic venous stasis ulcers, peripheral arterial occlusive disease/arterial insufficiency, and all other indications because there is inadequate evidence of their effectiveness for these indications.

For persons with a medically necessary inflatable compression garment (e.g., Flowtron Compression Garment, Jobst Pneumatic Compressor), a pump needed to inflate the compression garment is considered medically necessary.

See also CPB 069 - Lymphedema Treatments for Aetna's policy on pneumatic compression devices for arm lymphedema and CPB 482 - Compression Garments for the Legs.

Gradient elastic stockings, such as those made by Jobst, Sigvaris, Juzzo, or Medi, are generally viewed as the principle means of preventing complications of chronic venous insufficiency. Intermittent pneumatic compression devices compress the leg and/or foot and ankle and act as a pump to improve circulation in the lower extremities. Pneumatic compression devices consist of an inflatable garment for the leg and an electrical pneumatic pump that fills the garment with compressed air. The garment is intermittently inflated and deflated with cycle times and pressures that vary between devices.

Intermittent pneumatic compression boots are generally accepted as a method for preventing deep venous thromboses (DVT) and complications of venous stasis in persons after trauma, orthopedic surgery, neurosurgery, or who for other reasons are unable to walk.

Use of the intermittent pneumatic compression device has expanded to ambulatory persons who suffer from chronic venous insufficiency (CVI) of the legs and consequent edema, stasis dermatitis, ulcerations, and cellulitis. CVI of the legs is caused by abnormalities of the venous wall and valves, leading to obstruction or reflux of blood flow in the veins.

A systemic review of the literature concluded that the effectiveness of the addition of intermittent pneumatic compression in treatment of venous leg ulcers is unknown. The systemic review identified three small, randomized controlled trials of intermittent pneumatic compression; all of these trials were different in design. Upon pooling of the results, using a random effects model, the reviewers found no difference in healing rates. The review concluded that “[t]hree small [randomized controlled trials] found no evidence of a significant effect on healing with intermittent pneumatic compression in conjunction with compression bandages.”

There is no evidence that intermittent pneumatic compression devices are superior to gradient compression stockings in preventing complications of chronic venous disease. Compliance with gradient compression stockings has been shown to be essential to their effectiveness; the stockings do not work unless they are worn. There are no studies, however, that have demonstrated that compliance with intermittent pneumatic compression devices is significantly greater than compliance with gradient compression stockings.

The A-V Impulse System Foot Pump and the KCI Plexipulse are brands of intermittent pneumatic compression boots on the market; others include those manufactured by Jobst, Chattanooga, Kendal, and Nutech.

The Canadian Coordinating Office of Health Technology Assessment (2004) concluded that “EPC [external pneumatic compression] reduces the risk of DVT for patients who cannot walk due to trauma, joint surgery or neurosurgery. There is still limited evidence, however, supporting the effect of EPC on the healing of venous ulcers and other disorders resulting from chronic VI [venous insufficiency]”.

Current evidence supporting the use of pneumatic compression devices in peripheral arterial disease is limited to small pilot studies with short-term follow up. In a pilot study (n = 30), Ramaswami et al (2005) examined the usefulness of rapid, high-pressure, intermittent pneumatic calf and foot compression (IPCFC) in patients with stable intermittent claudication. These investigators concluded that “IPCFC improves walking distance in patients with stable intermittent claudication. The combination of IPCFC with other treatment such as risk-factor modification and daily exercise may prove useful in patients with peripheral arterial occlusive disease. It may be a useful first line of therapy in patients with disabling claudication who are unfit for major reconstructive surgery. Improved walking on long-term follow-up and experience from different centers may establish a role for this treatment modality in the future”.

Kakkos et al (2005) compared the effect of unsupervised exercise, supervised exercise and intermittent pneumatic foot and calf compression (IPC) on the claudication distance, lower limb arterial hemodynamics and quality of life of patients with intermittent claudication (n = 34). These researchers concluded that IPC achieved improvement in walking distance comparable with supervised exercise. Long-term results in a larger number of patients will provide valuable information on the optimal treatment modality of intermittent claudication.

Note: Aetna's standard HMO-based plans (HMO, QPOS, U.S. Access, Golden Medicare) do not cover graded compression stockings or non-elastic binders because they are considered an outpatient consumable or disposable supply. Please check benefit plan descriptions for details. HMO-based plans cover inflatable compression garments only for selected persons with lymphedema. (See CPB 069 - Lymphedema Treatments)

Inflatable compression garments*, non-elastic binders**, or individually fitted prescription graded compression stockings*** are considered medically necessary for members who have any of the following medical conditions:

1. Treatment of any of the following complications of chronic venous insufficiency:

   1. Varicose veins (except spider veins)
   2. Stasis dermatitis (venous eczema)
   3. Venous ulcers (stasis ulcers)
   4. Venous edema

   5. Lipodermatosclerosis

2. Prevention of thrombosis in immobilized persons (e.g., immobilization due to surgery, trauma, general debilitation, etc.)
3. Post thrombotic syndrome (post phlebitic syndrome)
4. Selected persons with chronic lymphedema (see CPB 069 - Lymphedema Treatments)
5. Edema following surgery, fracture, burns, or other trauma
6. Post sclerotherapy****
7. Postural hypotension
8. Severe edema in pregnancy
9. Edema accompanying paraplegia, quadriplegia, etc.

These compression garments for the legs are considered experimental and investigational for all other indications.

* The above reference to inflatable compression garments (e.g., Flowtron Compression Garment, Jobst Pneumatic Compressor) also includes the pump needed to inflate the compression garment. For Aetna's clinical policy on intermittent and sequential compression pumps for lymphedema, see CPB 069 - Lymphedema Treatments, and CPB 500 - Intermittent Pneumatic Compression Devices for the Legs.

**Aetna considers non-elastic leg binders (e.g., LegAssist, CircAid, Reid Sleeve) medically necessary for members who meet the selection criteria for pressure gradient support stockings listed above. Non-elastic leg binders are similar to graded compression stockings in that they provide static compression of the leg, but unlike graded compression stockings, they do not use elastic, but use adjustable Velcro or buckle straps.

***Applies only to pre-made or custom-made pressure gradient support stockings (e.g., Jobst, SigVarus, Venes, Juzo, etc.) that have a pressure of 18 mm Hg or more, that require a physician's prescription, and that require measurements for fitting.

****Only pressure gradient support stockings are considered medically necessary for this indication; inflatable compression garments have no proven value for this indication.

Stockings purchased over the counter without a prescription which have a pressure of less than 20 mm Hg (e.g., elastic stockings, surgical leggings, anti-embolism stockings (Ted hose) or pressure leotards) are considered experimental and investigational because these supplies have not been proven effective in preventing thromboembolism. Note: These OTC stockings are also not covered because they are not primarily medical in nature.

Replacements:

Replacements are considered medically necessary when the compression garment cannot be repaired or when required due to a change in the member's physical condition. For pressure gradient support stockings, no more than four replacements per year are considered medically necessary for wear.

Two pairs of compression stockings are considered medically necessary in the initial purchase (the 2nd pair is for use while the 1st pair is in the laundry).

Contraindications:

Compression garments are considered experimental and investigational for members with severe peripheral arterial disease or septic phlebitis because they are contraindicated in these conditions.

CPT^{®* Codes}

Description

97001

Physical therapy evaluation

97002

Physical therapy re-evaluation

97003

Occupational therapy evaluation

97004

Occupational therapy re-evaluation

97140

Manual therapy techniques(e.g., mobilization/manipulation, manual lymphatic drainage, manual traction)one or more regions,15 minutes

97530

Therapeutic activities, direct (one on one) patient contact by the provider (use of functional activities to improve functional performance),each 15 minutes

97535

Self-care/home management training (e.g., activities of daily living(ADL) and compensatory training, meal preparation, safety procedures, and instructions in use of assistive technology devices/adaptive equipment) direct (one on one) contact by provider, each 15 minutes

HCPCS Codes

Description

E0650

Pneumatic compressor; non-segmental home model

E0651

Pneumatic compressor; segmental home model without calibrated gradient

pressure

E0652

Pneumatic compressor; segmental home model with calibrated gradient pressure

E0655

Non-segmental pneumatic appliance for use with pneumatic compressor; half arm

E0660

Non-segmental pneumatic appliance for use with pneumatic compressor; full leg

E0665

Non-segmental pneumatic appliance for use with pneumatic compressor; full arm

E0666

Non-segmental pneumatic appliance for use with pneumatic compressor; half leg

E0667

Segmental pneumatic appliance for use with pneumatic compressor; full leg

E0668

Segmental pneumatic appliance for use with pneumatic compressor; full arm

E0669

Segmental pneumatic appliance for use with pneumatic compressor; half leg

E0671

Segmental gradient pressure pneumatic appliance; full leg

E0672

Segmental gradient pressure pneumatic appliance; full arm

E0673

Segmental gradient pressure pneumatic appliance; half leg

S8950

Complex lymphedema therapy, each 15 minutes

ICD-9-CM Diagnosis Codes

Description

125.9

Unspecified filariasis

257.0

Lymphedema

457.0

Post mastectomy elephantiasis

457.1

Elephantiasis

757.0

Milroy’s disease/hereditary lymphedema of the legs

990

Effects of radiation, unspecified

997.99

Post surgical elephantiasis

998.8

Complications of surgical lymph node removal