DESCRIPTION
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.
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 lipids, 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.
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. The FDA determined that this device was substantially equivalent to existing devices for treatment of leg vascular diseases and congestive heart failure.
In May 2009, “The Multicrus Circulator Boot™” was cleared for marketing by the FDA through the 510(k) process (K082134). This boot is adjustable in all three dimensions of length, height, and width.
POLICY
End-diastolic pneumatic compression boots for the treatment of vascular diseases and related conditions, including but not limited to lymphedema, are considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
See also: Lymphedema Devices
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Well-designed studies in peer-reviewed journals, which evaluate the clinical importance of end-diastolic pneumatic compression devices for the treatment of vascular disease and related conditions, are lacking.
SOURCES
Adams, K. E., Rasmussen, J. C., Darne, C., Tan, I. C., Aldrich, M. B., Marshall, M. V., et al. Direct evidence of lymphatic function improvement after advanced pneumatic compression device treatment of lymphedema. Biomedical Optics Express, 1 (1), 114-125. (Level 4 Evidence - Industry sponsored)
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2011). End diastolic pneumatic compression boot as a treatment of peripheral vascular disease or lymphedema (2.02.17). Retrieved April 18, 2011 from BlueWeb. (6 articles and/or guidelines reviewed)
Cannon, S. (2009). Pneumatic compression devices for in-home management of lymphedema: Two case reports. Cases Journal, 2, 6625.
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Pneumatic compression devices (NCD 280.6, p. 2-228). Ingenix.
Geerts, W. H., Berggvist, D., Pineo, G. F., Heit, J. A., Samama, C. M., Lassen, M. R., et al. (2008). Prevention of venous thromboembolism: American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest, 133 (6 Suppl), 381S-453S.
Lettieri, C. J., & Eliasson, A. H. (2009). Pneumatic compression devices are an effective therapy for restless legs syndrome: A prospective, randomized, double-blinded, sham-controlled trial. Chest, 135 (1), 74-80. (Level 2 Evidence - Independent study)
National Guideline Clearinghouse. (2010, August). Venous thromboembolism prophylaxis. Retrieved April 18, 2011 from http://www.guidelines.gov.
Sheth, N. P., Lieberman, J. R., & Della Valle, C. J. (2010). DVT prophylaxis in total joint reconstruction. The Orthopedic Clinics of North America, 41 (2), 273-280.
U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. LCDs for CIGNA Government Services. (2011, February). LCD for pneumatic compression devices (L5017). Retrieved April 18, 2011 from http://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=5017&ContrTypeId=10&ver=32&ContrNum=18003&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Tennessee&KeyWord=pneumatic+compression+devices+&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACAAAAAA&.
U. S. Food and Drug Administration (2009, May). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K082134. Retrieved April 18, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K082134.pdf.
U. S. Food and Drug Administration (2007, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K072666. Retrieved April 18, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/K072666.pdf.
U. S. Food and Drug Administration (2005, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K042217. Retrieved April 18, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf4/K042217.pdf.
ORIGINAL EFFECTIVE DATE: 1/1/2005
MOST RECENT REVIEW DATE: 5/12/2011
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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