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Date Printed: December 18, 2017: 11:27 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-E0000-48

Original Effective Date: 02/15/04

Reviewed: 01/28/10

Revised: 11/01/15

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

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates

DESCRIPTION:

End diastolic pneumatic compression has been investigated as a technique to improve peripheral circulation and thus treat peripheral vascular disease and its complications, including venous stasis ulcers, dermatitis and osteomyelitis, and soft tissue infections. This technique has also been investigated in the treatment of 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 Circulator Boot™ is and example of a device used for end diastolic pneumatic compression.

POSITION STATEMENT:

End diastolic pneumatic compression boots are considered experimental or investigational, as there are insufficient published clinical studies to support effects on health outcomes as a treatment of peripheral vascular disease or lymphedema and their associated complications, and specifically for the following indications:

BILLING/CODING INFORMATION:

There is no specific CPT or HCPCS code describing end diastolic pneumatic compression boots.

HCPCS Coding

NOTE: In 2000, HCPCS code G0166 (external counterpulsation, per treatment session) was introduced to describe external counterpulsation as a treatment of chronic refractory angina. Since the FDA classifies the Circulator Boot™ as an external counterpulsation device, this HCPCS code might possibly be used inappropriately by some providers to report the boot therapy.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Pneumatic Compression Devices (280.6) located at cms.gov.

The following Durable Medical Equipment Regional Carrier (DMERC) Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Pneumatic Compression Devices (L5017) located at cgsmedicare.com.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

DEFINITIONS:

Cellulitis: inflammation of subcutaneous, loose connective issue.

Claudication: usually referring to intermittent restriction in blood flow associated with pain.

Ischemic (ischemia): obstruction of blood supply.

Lymphedema: swelling in the subcutaneous tissues, as a result of obstruction of lymphatic vessels or lymph nodes in the affected region.

Necrotizing (necrosis): pathologic death of tissue or organ.

Stasis: stagnation of blood or other fluids.

Thrombophlebitis: venous inflammation with blood clot formation.

RELATED GUIDELINES:

External Counterpulsation (ECP), 01-93000-26
Lymphedema Pumps and Devices, 09-E0000-31

OTHER:

Indexing terms:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of
one product over another, and is not intended to represent a complete listing of all products available.

The Circulator Boot™
External Counterpulsation for peripheral artery disease
Multicrus Circulator Boot System

REFERENCES:

  1. Blue Cross Blue Shield Association Medical Policy Reference 2.02.17i, End Diastolic Pneumatic Compression Boot as a Treatment of Periopheral Vascular Disease or Lymphedema (08/02/07).
  2. Centers for Medicare and Medicaid Services (CMS), National Coverage Determination (NCD) for Pneumatic Compression Devices, Publication 100-3, section 280.6, 01/14/02 (last modified 04/23/09).
  3. Centers for Medicare and Medicaid Services (CMS), Region C DMERC Local Coverage Determination #L5017 for Pneumatic Compression Devices (010109).
  4. Circulator Boot Corporation website, accessed 12/10/09.
  5. Hayes Brief, Pneumatic Compression Devices for Treatment of Peripheral Lymphedema, 06/06/05.
  6. Kolbach DN, et al. “Compression therapy for treating stage I and II (Widmer) post-thrombotic syndrome”; Cochrane Database of Systematic Reviews 2006 Issue 4, updated 08/19/03.
  7. Mani R, et al. “Intermittent pneumatic compression for treating venous leg ulcers”; Cochrane Database of Systematic Reviews (2006), Issue 4, updated 07/01/01.
  8. National Guideline Clearinghouse. Agency for Healthcare Research and Quality (AHRQ). Summary algorithm for venous ulcer care with annotations of available evidence. Developed by the Association for the Advancement of Wound Care (AAWC). Last modified 11/03/08.
  9. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification (K971026, K833627/A, K792354), The Circulator Boot (12/06/07).
  10. U.S. Food and Drug Administration (FDA). 510(k) Premarket Notification (K082134). The Multicrus Circulator Boot System (05/07/09).

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 01/28/10.

GUIDELINE UPDATE INFORMATION:

02/15/04

New Medical Coverage Guideline.

02/15/06

Scheduled review with revisions consisting of removing E0675, adding cross-reference to the Lymphedema Pump MCG, and updating the references.

02/15/07

Scheduled review; no change in coverage statement.

06/15/07

Reformatted guideline.

02/15/08

Scheduled review; no change in position statement; references updated.

02/15/09

Scheduled review; position statement unchanged.

02/15/10

Scheduled review; position statement unchanged; references updated.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: December 18, 2017: 11:27 AM