648 Form

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Medical Policy End-Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema Table of Contents
• Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 648 BCBSA Reference Number: 2.02.17A (For Plan internal use only) NCD/LCD: NA Related Policies
• Non-Contact Ultrasound Treatment for Wounds, #657 • Enhanced External Counterpulsation (EECP) for Chronic Stable Angina or Congestive Heart Failure, #649

Policy
Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Members:

End-diastolic pneumatic compression boots are 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.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This is not a covered service. Commercial PPO and Indemnity This is not a covered service. Medicare HMO BlueSM This is not a covered service. Medicare PPO BlueSM This is not a covered service.

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CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The following HCPCS code is considered investigational for Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity:

HCPCS Codes

HCPCS codes: Code Description E0675 Pneumatic compression device, high pressure, rapid inflation/deflation cycle, for arterial insufficiency (unilateral or bilateral system)

Description 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. Venous stasis and lymphedema compress small arterioles and shunt blood from these areas.

End-diastolic pneumatic compression has been investigated in the treatment of peripheral vascular disease, venous stasis, and lymphedema. The end-diastolic pneumatic compression boot includes the following components: a heart monitor to detect the QRS complex of the electrocardiogram (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. Timed, sequential inflation during the end-diastolic portion of the cardiac cycle is applied to the boot and is designed both to allow maximal arterial flow into the leg and to expel venous blood and lymphatic fluid.

Examples of pneumatic compression boots for treatment of leg vascular diseases and congestive heart failure include The Circulator Boot™, The Miniboot and The Multicrus Circulator Boot™ from Circulator Boot Corporation and. All pneumatic compression boots for treatment of peripheral vascular disease and lymphedema are considered investigational regardless of the commercial name, the manufacturer or FDA approval status except when used for the medically necessary indications that are consistent with the policy statement.

Summary The available evidence 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.

Policy History Date Action

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4/2024 Clarified coding information 11/2022 Annual policy review. Policy updated with literature review through October 2022. No references added. Policy statements unchanged. 2/2020 Policy updated with literature review through February 1, 2020, references added. Policy statements unchanged. 12/2013 Removed reference to LCD L11503 as it does not meet the intent of this policy.
11/2013 Clarified coding information 2/2013 Annual policy review. New references added. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. No changes to policy statements.
4/2011 Reviewed - Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements. 4/2010 Reviewed - Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements. 4/2010 Annual policy review. No changes to policy statements. 4/2009 Reviewed - Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements. 1/2009 Annual policy review. No changes to policy statements. 4/2008 Reviewed - Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements. 10/2007 Annual policy review. No changes to policy statements. 4/2007 Reviewed - Medical Policy Group - Cardiology and Pulmonology. No changes to policy statements.

Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

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.