MEDICAL POLICY

POLICY
RELATED POLICIES
POLICY GUIDELINES
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

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

Number 2.02.17

Effective Date March 25, 2014

Revision Date(s) 03/10/14; 03/8/13; 03/13/12; 06/13/11; 06/09/09; 10/9/07; 07/11/06; 02/08/05; 01/13/04

Replaces N/A

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.

Related Policies

1.01.18

Pneumatic Compression Pumps for the Treatment of Lymphedema and Venous Ulcers

1.01.22

Skin Contact Monochromatic Infrared Energy as a Technique to Treat Cutaneous Ulcers, Diabetic Neuropathy, and Miscellaneous Musculoskeletal Conditions

2.01.82

Bioimpedance Devices for Detection and Management of Lymphedema

Policy Guidelines

End-diastolic pneumatic compression boot therapy is typically offered in a series of 40-minute sessions in an office setting.

Coding

There is no specific CPT or HCPCS code describing end diastolic pneumatic compression boots. A series of CPT codes may be used incorrectly 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.

The FDA classifies end diastolic pneumatic compression boots like the Circulator Boot™ as an external counterpulsation device.

CPT

93799

Unlisted cardiovascular service or procedure

HCPCS

G0166

External counterpulsation, per treatment session

Description

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.

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 aloneor in combination with other drug or device therapiesmay 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

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This policy does not apply to Medicare Advantage.

Benefit Application

N/A

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 debridement of necrotic tissue; non-weight bearing, adequate nutrition, and antibiotic therapy, if necessary (see Related Policies).

Literature Review

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 2,177 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 (i.e., 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

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.

References

  1. Dillon RS. Fifteen years of experience in treating 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.

Coding

Codes

Number

Description

CPT

92971

Cardioassist-method of circulatory assist; external

 

99199

Unlisted special procedure or report

ICD-10-CM
(effective 10/01/14)

I70.211-I70.213

Atherosclerosis of native arteries of extremities with intermittent claudication, leg, code range

 

I73.9

Peripheral vascular disease, unspecified

 

I80-00-I80.9

Phlebitis and thrombophlebitis code range

 

I83.10-I83.12

Varicose veins of lower extremities with inflammation code range

 

I83.202-I83.209;
I83.212-I83.219;
I83.222-I83.229

Varicose veins of lower extremities with both ulcer and inflammation code range

 

I89.0

Lymphedema, not elsewhere classified

HCPCS

G0166

External counterpulsation, per treatment session

Type of Service

Medicine

 

Place of Service

Physician Office

 

Appendix

N/A

History

Date

Reason

01/13/04

Add to Medicine section, Cardiology subsection - New policy

02/08005

Replace Policy - Policy updated with literature review; no change in policy statement.

07/11/06

Replace Policy - Policy updated with literature review; no change in policy statement.

10/09/07

Replace Policy - Policy updated with literature review; no change in policy statement.

08/12/08

Cross Reference Update - No other changes.

06/09/09

Replace Policy - Policy updated with literature review; no change in policy statement. Reference added.

11/10/09

Cross Reference Update - No other changes.

06/08/10

Cross Reference Update - No other changes.

06/13/11

Replace Policy - Policy returned to active review and updated with literature search, reference number 6 added, policy statement unchanged. ICD-10 codes added to policy.

03/23/12

Replace policy. Policy updated with literature review through November 2011; policy statement unchanged. Add coded 99199; others removed.

08/24/12

Update Related Policies – Add 1.01.18. Update Coding Section – ICD-10 codes are now effective 10-01-14.

09/13/12

Update Related Policies – Add 2.01.82.

12/19/12

Update Related Policies – Change title for 1.01.18.

03/08/13

Replace policy. A literature review through November 2012 did not prompt any changes to the rationale section. No new references added. Policy statement unchanged. Remove Related Policy 1.01.16 as it was archived.

01/30/14

Update Related Policies. Change title to 2.01.82.

03/25/14

Replace policy. Policy reviewed with literature review through December 20, 2013 that did not prompt any additions to the reference section. Policy statement unchanged.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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