End Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema

POLICY NUMBER

L.2.02.405

DESCRIPTION

The end-diastolic pneumatic compression boot includes the following components: a heart monitor to detect the QRS complex of the EKG and to appropriately time boot compressions in the end portion of the heart cycle; a rapid action valve assembly capable of both pressurizing and exhausting the boots; rigid, adjustable long boots to enclose the leg from groin to toes; and double-walled plastic bags to enclose the treated portion of the leg and to contain the compressed air.

Poor lower extremity circulation can be associated with compromised arterial flow, impaired venous return or both. When oxygen demand exceeds the supply to the lower extremity, such as during physical activity, claudication pain can result. Small amounts of oxygen deprivation over a chronic period will lead to skin breakdown and poor healing capacity. Peripheral artery disease, typically caused be arteriosclerosis, worsens with age, smoking, high lipids and diabetes. Venous stasis and lymphedema compress small arterioles and shunt blood from these areas.

Therapeutic approaches to peripheral artery disease include risk factor modification, control of diabetes, hypertension and hyperlipidemia, aspirin and other antiplatelet therapies, and progressive exercise. Percutaneous or open surgical procedures can reestablish arterial flow. Approaches to venous stasis include compression and elevation.

End diastolic pneumatic compression has been investigated in the treatment of peripheral vascular disease, venous stasis and lymphedema. Timed, sequential inflation during the end diastolic portion of the cardiac cycle is applied to a boot enclosing the foot or ankle, or extending from the toes to the groin, and is designed both to allow maximal arterial flow into the leg and to expel venous blood and lymphatic fluid.

In January 1980, device “The Circulator Boot™” (Circulator Boot Corporation, Malvern, PA) was cleared for marketing by the FDA through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices for treatment of leg vascular diseases and congestive heart failure. In May 1984, the FDA approved a modification to limit the treatment area to the lower leg: The Miniboot. In August 1997, the FDA approved a computerized delay timing based on electrocardiogram.

In May 2009, “The Circulator Boot™” was cleared for marketing by the FDA through the 510(k) process as follows: “The Circulator Boot System alone - or in combination with other drug or device therapies - may be prescribed by the physician to treat:

Poor arterial flow in extremities associated with:

• Ischemic ulcers

• Rest pain or claudication (pain with walking)

• Threatened gangrene

• Insufficient blood supply at amputation site

• Persisting ischemia after embolectomy or bypass surgery

• Pre- and post-arterial reconstruction to improve runoff

Diabetes complicated by the above or other conditions possible related to arterial insufficiency including:

• Nocturnal leg cramps

• Necrobiosis diabeticorum

Venous disease (once risk of emboli minimized)

• Prophylaxis of deep vein thrombophlebitis

• Edema and induration associated with chronic venous stasis

• Venous stasis ulcers

Athletic injuries: “Charlie horses”, pulled muscles, and edematous muscles

POLICY

End diastolic pneumatic compression boots are considered investigational as a treatment of peripheral vascular disease or lymphedema and its associated complications, including but not limited to ischemic lesions, claudication pain, necrotizing cellulitis, venous stasis ulcers, stasis dermatitis, chronic lymphedema, or thrombophlebitis. 

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

There are no specific CPT codes for this technology, but a series of CPT codes may be used to describe the individual components of the overall therapy, similar to those used for external counterpulsation therapy for chronic refractory angina or congestive heart failure.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/27/2006: Approved by Medical Policy Advisory Committee (MPAC)

08/03/2011: Policy description updated. Policy statement unchanged. FEP verbiage added to the Policy Exception section.

02/24/2012: Policy reviewed; no changes.

04/04/2013: Policy reviewed; no changes.

03/11/2014: Policy reviewed; no changes.

07/20/2015: Code Reference section updated for ICD-10.

06/06/2016: Policy number L.2.02.405 added. Investigative definition updated in Policy Guidelines section.

03/21/2023: Policy reviewed; no changes.

04/29/2024: Policy reviewed; no changes.

03/28/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.02.17

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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