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 (ECG) 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 Corporation, Malvern, PA) was cleared for marketing by the U.S. Food and Drug Administration (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

• Nocturnal leg cramps
• Necrobiosis diabeticorum

• Prophylaxis of deep vein thrombophlebitis
• Edema and induration associated with chronic venous stasis
• Venous stasis ulcers

• “Charlie horses,” pulled muscles, and edematous muscles

• Negative-Pressure Wound Therapy (Policy #013 in the Treatment Section)
• Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers (Policy #013 in the DME Section)
• Skin Contact Monochromatic Infrared Energy as a Technique to Treat Cutaneous Ulcers, Diabetic Neuropathy, and Miscellaneous Musculoskeletal Conditions (Policy #068 in the Treatment Section)
• Non-Contact Ultrasound Treatment for Wounds (Policy #122 in the Treatment Section)
• Enhanced External Counterpulsation (EECP) (Policy #014 in the Treatment Section)

FIDE-SNP Coverage:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

Billing
End-diastolic pneumatic compression therapy should be reported with CPT code 99199 with End-diastolic pneumatic compression therapy noted in the narrative portion of the claim.


[RATIONALE: This policy was created in 2004 and updated periodically with searches of the MEDLINE database. The most recent literature update was performed through February 2020.

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 . 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.

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.

SUPPLEMENTAL INFORMATION

Practice Guidelines and Position Statements
No guidelines or statements were identified.

U.S. Preventive Services Task Force Recommendations
Not applicable.]
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
End Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema
Circulator Boot
External Counterpulsation Therapy, Peripheral Vascular Disease or Lymphedema

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):523-35.

3. Dillon RS. Effect of therapy with the pneumatic end-diastolic leg compression boot on peripheral vascular test and on the clinical course of peripheral vascular disease. Angiology 1980; 31(9):614-38.

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 1986; 204(6):643-9.

6. Filp JR, Dillon RS. Treatment of end-stage “trash feet” with the end-diastolic pneumatic boot. Angiology 2008; 59(2):214-9.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

99199