ARCHIVED

Medical Policy

Policy Num:      02.002.014
Policy Name:    End-Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema
Policy ID:          [2.002.014][Ac B M P ][2.02.17]

Last Review:     November 28, 2022
Next Review:     Archived Policy
Issue:                 11:2022

ARCHIVED

Related Policies:

01.002.004 Negative Pressure Wound Therapy in the Outpatient Setting

08.001.029 Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers

01.001.014 Monochromatic  Energy Infrared Contact in The Treatment of Skin Ulcers, Diabetic Neuropaty, and Musculoskeletal Conditions

02.001.052 Non-Contact Ultrasound Treatment for Wounds

02.002.012 Enhanced External Counterpulsation

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

Summary

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. The available evidence, which consists of case series, is insufficient to determine if there is a role for enddiastolic pneumatic compression therapy in the treatment of peripheral vascular disease or lymphedema and its associated complications. Randomized controlled trials comparing outcomes with currently available treatments are required. Therefore, the treatment is considered investigational.

Objective

The objective of this review is to compare End-diastolic pneumatic compression boot therapy with standard management of  peripheral vascular disease, venous stasis, and lymphedema

Policy Statements

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 Guidelines

End-diastolic pneumatic compression boot therapy is typically offered in a series of 40-minute sessions in an office setting. 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. See the coding section for further detail. In 2000, HCPCS code G0166 (external counterpulsation, per treatment session) was introduced to describe external counterpulsation as a treatment of chronic refractory angina. However, the U.S. Food and Drug Administration (FDA) classifies the circulator boot as an external counterpulsating device, and thus this HCPCS code might possibly be used by some providers for the boot therapy. The unlisted CPT code 93799 (unlisted cardiovascular service or procedure) might be used for this service.

Benefit Application

BlueCard/National Account Issues

State or federal mandates (eg, FEP) may dictate that all FDA-approved devices may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.  

Background

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 by arteriosclerosis, worsens with age, smoking, high lipid levels, 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.

The end-diastolic pneumatic compression boot includes the following components: a heart monitor to detect the QRS complex of the electrocardiogram 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

Regulatory Status

In January 1980, “The Circulator Boot™” (Circulator Boot Corp., Malvern, PA) was cleared for marketing FDA through the 510(k) process. FDA determined that this device was substantially equivalent to existing devices for treatment of leg vascular diseases and congestive heart failure.

In May 1984, FDA approved a modification to limit the treatment area to the lower leg: The Miniboot. In August 1997, FDA approved a computerized delay timing based on electrocardiogram.

In May 2009, “The Multicrus Circulator Boot™” was cleared for marketing by FDA through the 510(k) process (K082134). This boot is adjustable in all three dimensions of length, height, and width. The clearance notes that 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 postarterial reconstruction to improve runoff Diabetes complicated by the above or other conditions possibly 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 

Rationale

This policy was created in 2003 and updated periodically with searches of the MEDLINE database. The most recent literature update was performed through December 20, 2013.

As noted in other policies focusing on treatment of cutaneous ulcers, randomized controlled trials are particularly important to isolate the contribution of any single therapy to an overall program of wound management, which typically includes sharp débridement of necrotic tissue, non-weight bearing, adequate nutrition, and antibiotic therapy, if necessary (see Policy Nos.1.01.16, 2.01.16).

Searches of the literature identified several published articles on end-diastolic compression boot therapy authored by a single investigator, Richard Dillon, and all of them uncontrolled case series. In the largest case series, Dillon reported on 15 years of experience in treating 2177 episodes of foot and leg lesions (with a variety of etiologies) with the circulator boot.1 While the author reported that there was “deterioration” in a greater proportion of control (ie, initially uninvolved) legs compared to the treated leg, the heterogeneous group of patients and the lack of randomization limit interpretation of these data. Other published studies consist of small case series with the same limitations.2-5

Updated searches of the MEDLINE database identified only 1 report that was authored by Filp and Dillon of a series of 27 patients (41 legs) with cholesterol-embolization syndrome (CES) treated between 1997 and 2005.6 The alternate therapy offered to most patients at the time of referral was limb amputation. After a median interval of 11 months (range, 3-32 months) after initiation of therapy, 33 legs were totally healed, 6 improved, and 2 amputated. One patient died of causes unrelated to CES or use of the circulator boot. Another improved and discontinued treatment before he was totally healed. The authors concluded that the circulator boot seems to be the only effective therapy for CES. No comparison to alternative interventions at the time of treatment is possible, and treatment, particularly for cutaneous ulcers associated with vascular insufficiency, has continued to evolve since the patients in this study were treated. S

Summary of Evidence

End-diastolic pneumatic compression has been investigated in the treatment of peripheral vascular disease, venous stasis, and lymphedema. The available evidence, which consists of case series, is insufficient to determine if there is a role for end-diastolic pneumatic compression therapy in the treatment of peripheral vascular disease or lymphedema and its associated complications. Randomized controlled trials comparing outcomes with currently available treatments are required. Therefore, the treatment is considered investigational.

Population Reference No. 1 Policy Statement

The available evidence, which consists of case series, is insufficient to determine if there is a role for enddiastolic pneumatic compression therapy in the treatment of peripheral vascular disease  and its associated complications

Population Reference No. 2 Policy Statement

The available evidence, which consists of case series, is insufficient to determine if there is a role for enddiastolic pneumatic compression therapy in the treatment of lymphedema and its associated complications .

Supplemental Information

None

Practice Guidelines and Position Statements

No guidelines or statements were identified.

Medicare National Coverage

There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.

References

1. Dillon RS. Fifteen years of experience in treating 2177 episodes of foot and leg lesions with the circulator boot. Angiology. 1997;48(5 pt 2):S17-34.

2. Dillon RS. Improved hemodynamics shown by continuous monitoring of electrical impedance during external counterpulsation with the end-diastolic pneumatic boot and improved ambulatory EKG monitoring after 3 weeks of therapy. Angiology. 1998;49(7):523-535.

3. Dillon RS. Effect of therapy with the pneumatic end-diastolic leg compression boot on peripheral vascular tests and on the clinical course of peripheral vascular disease. Angiology. Sep 1980;31(9):614-638. PMID 7212381

4. Dillon RS. Treatment of resistant venous stasis ulcers and dermatitis with the end diastolic pneumatic compression boot. Angiology. 1986;37(1):47-56.

5. Dillon RS. Successful treatment of osteomyelitis and soft tissue infections in ischemic diabetic legs by local antibiotic injections and the end-diastolic pneumatic compression boot. Ann Surg. Dec 1986;204(6):643-649. PMID 3789836

6. Filp JR, Dillon RS. Treatment of end-stage “trash feet” with the end-diastolic pneumatic boot. Angiology. 2008;59(2):214-219.

Codes

Appplicable Modifiers

Some modifiers

Policy History