Medical Policy: 01.01.17
Original Effective Date: September 2009
Reviewed: September 2020
Revised: September 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Pneumatic compression pumps are proposed as a treatment option for patients with lymphedema who have failed conservative measures. They are also proposed to supplement standard of care for patients with venous ulcers. A variety of pumps are available; they can be single chamber (non-segmented) or multi-chamber (segmented) and have varying design and complexity.
Pneumatic compression devices consist of an inflatable garment for the arm, leg, trunk, or chest 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.
There are 3 primary types of pumps:
In general, a non-segmented or segmented compression device without manual control is considered sufficient to meet the needs of the individual. Typically, the only time a segmented, calibrated gradient pressure device would be indicated is when the individual has contractures or extensive scarring that prevents them from receiving satisfactory treatment from a non-segmented or segmented device without manual control due to safety concerns. This policy addresses various conditions for which pneumatic compression devices have been investigated for use.
There is insufficient evidence in the peer-reviewed literature that segmental compression pumps with calibrated, gradient pressure two-phase lymph preparation and drainage therapy devices provide outcomes equal or superior to standard pneumatic compression devices. One randomized, single-center, crossover study involving 10 patients that compared the efficacy of the Flexitouch™ device to massage for treatment of lymphedema of the arm was found in the literature. The study was limited by small sample size, short duration of treatment and no comparison to standard pneumatic lymphedema pumps or complex lymphedema therapy. Another similar study compared pressure delivered to parts of the arm between a segmental compression pump and the Flexitouch device. Differences in delivered pressures between the two devices was observed, but no conclusion regarding the optimal pressure needed was made.
Lymphedema is caused by an abnormality of the lymphatic system leading to excessive build-up of tissue fluid that forms lymph, known as interstitial fluid. Stagnant lymph fluid contains protein and cell debris that causes swelling of affected tissues. Left untreated, lymphedema leads to chronic inflammation, infection and hardening of the skin that, in turn, results in further lymph vessel damage and distortion of the shape of affected body parts.
Interstitial fluid can build up in any area of the body that has inadequate lymph drainage and cause lymphedema. Lymphedema is a condition that develops slowly and once present is usually progressive.
The gold standard treatment for lymphedema is complex decongestive therapy (CDT). This includes manual lymphatic drainage, compression bandaging, exercise, skin care, and education in self-management techniques.
Lymphedema is divided into two broad classes according to etiology:
Although the impact of arm/extremity lymphedema has been well studied and documented, very little attention has been focused on the impact of trunk (truncal) and chest edema. There is insufficient evidence that treating the truncal/chest area in addition to the limb affected by lymphedema improves the outcomes of pneumatic compression pump therapy more than only treating the limb. Further research is indicated and clinically meaningful reductions in truncal girth should also be defined.
Conservative measures for the treatment of lymphedema include, but are not limited to elevation of the affected limb, exercise, massage, and use of a compression bandage system or compression garment.
The evidence on pneumatic compression pumps applied to the limb for patients with lymphedema includes randomized controlled trials (RCTs) and systemic reviews of RCTs. Relevant outcomes are symptoms, change in disease status, functional outcomes and quality of life. The majority of these RCTs were rated as moderate to high quality by an Agency for Healthcare Research and Quality review, and about half reported significant improvement with pumps compared with conservative care. The evidence is sufficient to determine qualitatively that the technology results in meaningful improvement in the net health outcome.
Based on the peer reviewed medical literature the role of trunk or chest pneumatic compression therapy in the treatment of lymphedema is lacking, the clinical effectiveness of these devices cannot be determined and their role in the management of lymphedema has not been established and further research is indicated.
Two published RCTs have compared pneumatic compression treatment with and without truncal involvement. In 1 RCT, 2 of 4 key outcomes were significantly better with truncal involvement than without. This trial was limited by small sample size, failure to adjust statistically for multiple primary outcomes, and use of intermediate outcomes (eg, amount of fluid removed) rather than health outcomes (eg, functional status, quality of life). The other RCT did not find statistically significant differences between groups for any of the efficacy outcomes. The available evidence does not demonstrate that pumps treating the trunk or chest provide incremental improvement beyond that provided by pumps treating the affected limb only.
Chronic venous insufficiency (CVI) of the lower extremities is a condition caused by abnormalities of the venous wall and valves, leading to obstruction or reflux of blood flow in the veins. Signs of CVI include hyperpigmentation, stasis dermatitis, chronic edema, and venous ulcers.
Compression therapy remains the cornerstone of management for patients with chronic venous insufficiency, particularly those with venous ulceration. The goals of treatment are ulcer healing, reduction of edema, and improvement of pain. Prior to using compression therapy, it is important to confirm that the ulcer is due to chronic venous insufficiency rather than ischemia, or of mixed origin. Compression therapy is contraindicated in patients with peripheral artery disease.
Conservative measures for the treatment of venous stasis ulcers includes a compression bandage system or compression garment, appropriate dressings for the wounds, exercise, and elevation of the affected limb.
While there is limited evidence in the peer-reviewed medical literature supporting the efficacy of pneumatic compression devices for the treatment of patients with refractory edema from chronic venous insufficiency (CVI) with significant ulceration of the lower extremities who have failed standard therapy (i.e., a compression bandage system or garment, dressings for the wounds, exercise, and elevation of the limb), these devices are considered when standard compression bandaging has not been of benefit. There is insufficient evidence in the published, scientific literature to support the safety and/or effectiveness of pneumatic compression devices in the treatment of other conditions (e.g., peripheral artery disease/arterial insufficiency, diabetic neuropathic ulcers of the lower extremities, fracture and soft-tissue healing, restless leg syndrome, rehabilitation for distal radial fracture, management of edema following femero-popliteal bypass surgery, treatment of sensory impairment in upper limb following a stroke and treatment of upper extremity vascular ulcers) and therefore, considered investigational.
This technique is also used to stop blood clots developing after surgery in the home setting. The review of trials found conflicting evidence about whether or not pneumatic compression is equivalent to pharmacological prophylaxis in higher risk patients, and there are no studies that show improved health outcomes for low risk individuals over early ambulation.
A 2013 Consensus statement from the International Union of Phlebology (IUP) stated that primary lymphedema can be managed effectively by a sequenced and targeted management program based on a combination of decongestive lymphatic therapy and compression therapy. Treatment should include: compression garments, self massage, skin care, exercises, and, if desired, pneumatic compression therapy applied in the home.
In 2014 Society of Vascular Surgery issued a clinical practice guideline for the management of venous leg ulcers that states:
Rapid response 2017: The evidence suggested that intermittent pneumatic compression (IPC) may not provide additional benefits when used in combination with routine management of lymphedema. No literature for the comparative clinical effectiveness between single chamber and multi-chamber IPC devices was identified. A 2014 evidence-based guideline recommended the short-term use of IPC in combination with a lymphedema treatment program for reducing breast cancer-related lymphedema. The evidence from the included systematic reviews and randomized controlled trials suggested that IPC may not provide additional benefits when used in combination with the routine management of lymphedema.
Survivors at risk for lymphedema when symptoms exist (e.g. swelling, feelings of heaviness or fullness) should be provided lymphedema education, including self-care management. There should be referral to a lymphedema therapist (if available), for consideration of:
A technology assessment requested by Centers for Medicare and Medicaid Services (CMS) conducted by McMaster University Evidence-based Practice Center for the Agency for Healthcare Research and Quality (AHRQ) diagnosis and treatment of secondary lymphedema. The review included randomized controlled trials or observation studies with comparison groups (e.g., cohort, case control). The assessment included the following:
Regarding the question of whether one type of pneumatic compression device and sleeve (e.g., nonsegmented compression device, sequential segmented compression , or segmented compression with calibrated gradient pressure) is more effective in reducing lymphedema than another for any type of lymphedema along the continuum, or patient characteristics—the review found that there was a lack of evidence from which to determine whether one type of intermittent pneumatic compression device and sleeve were more effective in reducing lymphedema based on specific sets of patient characteristics:
Single compartment or multi-chamber nonprogrammable/non self-calibrated pneumatic compression devices/lymphedema pumps for the treatment of lymphedema may be considered medically necessary when all of the following are met:
Single or multichamber programmable/self-calibrated pneumatic compression devices/lymphedema pumps may be considered medically necessary for the treatment of lymphedema when:
*Lymphostatic fibrosis is present in all stages of lymphedema. The element of scarring and or contracture within the above criteria does not refer to the inherent pathophysiologic lymphostatic staging and progression of the underlying lymphedema disease.
*Previous abdominal surgery, perceived risk of truncal edema, or intolerance to 30mmHG do not qualify a patient’s utilization of the more advanced programmable pumps at this time.
The literature has failed to prove that with certainty the non-programmable pumps are inferior to programmable compression, and programmable compression should only be utilized for those physically unable to utilize the non-programmable variety as noted above. There is no consensus in the scientific literature on optimal pump selection and use. The scientific evidence supporting the use of pneumatic pumps as a solitary treatment modality for lymphedema is extremely limited and of poor quality. The evidence to support calibrated over non-calibrated pumps is insufficient in proving otherwise.
Discomfort alone is not a medically necessary indication for programmable/self-calibrating pneumatic compression therapy.
The use of calibrated pumps will be considered not medically necessary in all other clinical situations of lymphedema including but not limited to groin edema involvement. The member may be considered for non-programmable pumps when they fail to meet additional criteria for programmable/self-calibrated pumps (see medical necessity criteria above).
There is not sufficient scientific unbiased evidence that calibrated pumps (E0652) are more effective in treating lymphedema. The level of compression when extremely decreased in the calibrated pumps does not provide a level of compression proven to improve lymphedema. A 2-phase lymph preparation and drainage therapy device (e.g., Flexitouch Device, Tactile Systems Technology, Minneapolis, MN; LymphaPress Optimal, Lympha Press USA, Manalapan, NJ) is considered equally effective to standard segmented pneumatic compression devices with non-calibrated gradient pressure in available literature. The ACTitouch Adaptive Compression Therapy System has been shown to be equally effective to standard segmented pneumatic compression devices without calibrated gradient pressure.
The use of pneumatic compression devices/lymphedema pumps to treat the trunk, chest, head or neck in patients with lymphedema limited to the upper and/or lower limbs including use in patients where edema is anticipated but not currently present is considered not medically necessary.
Based on the peer reviewed medical literature the role of trunk and chest or head and neck pneumatic compression therapy in the treatment of lymphedema is lacking, the clinical effectiveness of these devices cannot be determined and their role in the management of lymphedema has not been established and further research is indicated. There is insufficient evidence that treating the truncal/chest area in addition to the limb affected by lymphedema improves the outcomes of pneumatic compression pump therapy more than only treating the limb.
Based on the peer reviewed medical literature the role head and neck compression therapy in the treatment of lymphedema is lacking, the clinical effectiveness of these devices cannot be determined and their role in the management of lymphedema has not been established. Clinical guidelines fail to include pneumatic compression devices within this management algorithm and further research is indicated. The use is considered investigational.
Pneumatic compression devices (single chamber/nonsegmental) (E0650, E0660, E0666) may be considered medically necessary for the treatment of chronic venous insufficiency of the lower extremities with non-healing venous stasis ulcer(s) after a six month trial of conservative therapy which includes all of the following:
All other uses of pneumatic compression devices including but not limited to the following are considered investigational because the safety and/or effectiveness of these devices cannot be established by review of the available peer reviewed literature:
Single patient use intermittent pneumatic compression device (e.g., the VenaPro Vascular Therapy System) (E0676) is considered investigational.
Documentation should be readily available to support conservative therapy (failure of conservative therapy documenting daily usage and no improvement of limb circumference) and pump selection requirements.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.