Pneumatic Compression Pumps
Lymphedema is an abnormal accumulation of lymphatic fluid in subcutaneous tissue. This could be the result of a congenital anomaly or damage to the lymphatic system (e.g., removal of lymph nodes, blockage of lymphatic channels by a tumor, scarring of lymphatic channels from radiation, or as a result of surgery or trauma). Lymphedema can occur immediately following surgery or years later. Lymphedema is a chronic condition for which there is no cure. If the condition is not treated it can result in skin deterioration, venous ulcers, fibrosis, and loss of limb mobility. Some FDA-cleared devices for lymphedema are Lympha Press Optimal, Flexitouch®, NanoTherm™, Sequential Circulator®, Restep®, Venowave™, and ActiveCare.
Major surgery, especially orthopedic surgery, promotes high risk for venous thromboembolism. Pharmacologic prophylaxis is the mainstay of treatment, but some patients may have contraindications to anticoagulation. For these patients having high-risk surgeries, pneumatic limb compression is a reasonable option if prophylaxis is indicated following hospitalization.
Pneumatic compression pumps are proposed treatment options for lymphedema, venous ulcers, and venous thromboembolism prophylaxis. Limb compression devices are commonly used in the hospital setting as DVT prophylaxis and are proposed in the outpatient setting following hospitalization, with or without pharmacologic prophylaxis. Newer devices are battery powered and recommended to allow freedom of movement to the patient which therefore encourages mobilization.
NOTE: This policy does not address end-diastolic compression pumps which are a very specialized pneumatic compression pump designed to coordinate the timing of the intermittent boot compression with the QRS complex on the EKG.
The use of pneumatic compression pumps in the home setting for the treatment of lymphedema or prophylactic treatment of deep vein thrombosis (DVT) are considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Pneumatic compression pumps for treatment of venous ulcers 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: End Diastolic Pneumatic Compression Boot as a Treatment of Peripheral Vascular Disease or Lymphedema
Pneumatic compression pumps are considered medically appropriate if ANY ONE of the following are met:
DVT prophylaxis for postoperative use in the home setting if ALL of the following are met:
Contraindication to pharmacological agents, i.e., at high risk for bleeding.
Intermittent pneumatic device
No longer than 14 days
Lymphedema if ANY ONE of the following are met:
Nonprogrammable pump, singe or multi-chamber, for intractable lymphedema of one or more limbs documented failure to respond to conservative measures of limb elevation and compression garments
Programmable pump, single or multi-chamber, if there is documented failure to respond to conservative measures of limb elevation and compression garments, and documentation is present that the individual has characteristics that prevent satisfactory pneumatic compression performance from nonprogrammable pneumatic compression, such as significant scarring or contractures.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes 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. These examples are contained in the parenthetical e.g. statement.
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.
An insufficient number of controlled studies were found in the published literature to validate the home application of pneumatic compression pumps for venous ulcers or provide comparisons to standard treatment. Therefore, the use of these devices for this purpose remains investigational at this time.
American Academy of Orthopaedic Surgeons. (2011). Preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. Evidence-based guideline and evidence report. Retrieved March 2, 2016 from http://www.aaos.org.
American College of Chest Physicians. (2012, February). Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. prevention of venous thromboembolism in orthopedic surgery patients. Retrieved February 29, 2016 from http://journal.publications.chestnet.org.
American Venous Forum. (August, 2014). Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. Retrieved March 20, 2017 from the National Guideline Clearinghouse. (NGC: 010764).
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2018). Pneumatic compression pumps for treatment of lymphedema and venous ulcers. (1.01.18). Retrieved March 28, 2018 from BlueWeb. (13 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2018). Postsurgical outpatient use of limb compression devices for venous thromboembolism prophylaxis. (1.01.28). Retrieved March 28, 2018 from BlueWeb. (24 articles and/or guidelines reviewed)
Cahaba Government Services Administrators, LLC. (2017, January) Local Coverage Determination (LCD): pneumatic compression devices (L33829). Retrieved March 28, 2018 from https://www.cms.gov.
Centers for Medicare & Medicaid Services. CMS.gov. (2002) National Coverage Determination (NCD) for pneumatic compression devices (280.6). Retrieved March 17, 2017 from https://www.cms.gov.
Dolibog, P., Franek, A., Taradaj, J., Dolibog, P., Blaszczak, E., Polak, A., et al. (2014). A comparative clinical study on five types of compression therapy in patients with venous leg ulcers. International Journal of Medical Science, 11 (1), 34-43. (Level 4 evidence)
National Institute for Health and Care Excellence. (2014, June). The geko device for reducing the risk of venous thromboembolism. Retrieved March 20, 2017 from www.nice.org .
O’Connell, S., Bashar, K., Broderick, B., Sheehan, J., Quondamatteo, F., Walsh, S., et al. (2016). The use of intermittent pneumatic compression in orthopedic and neurosurgical postoperative patients: A systematic review and meta-analysis. Annals of Surgery, 263 (5), 888-889. Abstract retrieved March 20, 2017 from PubMed database.
Sadaghianloo, N., & Dardik, A. (2016). The efficacy of intermittent pneumatic compression in the prevention of lower extremity deep venous thrombosis. Journal of Vascular Surgery: Venous and Lymphatic Disorders, 4 (2), 248-256. Abstract retrieved March 20, 2017 from PubMed database.
U. S. Food and Drug Administration. (2008, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K082149. Retrieved March 14, 2013 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2011, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K110276. Retrieved March 8, 2013 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2012, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K112441. Retrieved March 8, 2013 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2014, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K140813. Retrieved August 10, 2015 from http://www.accessdata.fda.gov.
Windisch, C., Kolb, W., Kolb, K., Grützner, P., Venbrocks, R., & Anders, J. (2011). Pneumatic compression with foot pumps facilitates early postoperative mobilization in total knee arthroplasty. International Orthopedics, 35 (7), 995-1000. (Level 2 evidence)
Winifred S. Hayes, Inc. Medical Technical Directory. (2013, August; last update search July 2017). Pneumatic compression for prevention of deep vein thrombosis following knee surgery. Retrieved March 28, 2018 from www.Hayesinc.com/subscribers. (55 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technical Directory. (2013, July; last update search June 2017). Intermittent pneumatic compression for peripheral arterial disease. Retrieved March 28, 2018 from www.Hayesinc.com/subscribers. (47 articles and/or guidelines reviewed)
Zaleska, M., Olszewski, W., & Durlik, M. (2014). The effectiveness of intermittent pneumatic compression in long-term therapy of lymphedema of lower limbs. Lymphatic Research and Biology, 12 (2), 103-109. (Level 4 evidence)
ORIGINAL EFFECTIVE DATE: 6/1998
MOST RECENT REVIEW DATE: 5/10/2018
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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