Pneumatic Compression Pumps
DESCRIPTION
Pneumatic compression pumps (PCPs), also known as limb compression devices, are a proposed treatment option for lymphedema, venous ulcers, and deep venous thromboembolism (DVT) prophylaxis. A variety of pumps are available, including single chamber (nonsegmented) and multi-chamber (segmented), with varying designs and complexity. Newer devices are battery powered to allow freedom of movement which encourages mobilization.
Lymphedema is an abnormal accumulation of lymphatic fluid in subcutaneous tissue. Conservative therapy includes limb elevation and exercise as well as the use of compression garments and bandaging. Another conservative treatment is manual lymphatic drainage, a massage-like technique used to move edema fluid from distal to proximal areas. For individuals who have failed conservative therapy, pneumatic compression pumps applied to the limb may be a treatment option. Examples of FDA-cleared devices include: the Compression Pump, Model GS-128, the Sequential Circulator®, the Lympha-Press® and Lympha-Press Optimal, the Flexitouch™ and the Powerpress Unit Sequential Circulator. PCPs that include the trunk, chest, head and neck (e.g., FlexiTouch® System) have also been proposed as advanced lymphedema therapy.
Venous ulcers, which occur most commonly on the medial distal leg, can develop in individuals with chronic venous insufficiency. Standard treatment includes compression bandages or hosiery supplemented by conservative measures such as leg elevation and exercise. Pneumatic compression pumps (e.g., Model GS-128, Lympha-Press®, Powerpress Unit Sequential Lymphedema Systems) have been proposed as a treatment for venous ulcers.
Pneumatic compression pumps are also proposed for use as prophylactic treatment of deep vein thrombosis following major surgery in individuals with contraindications to anticoagulation.
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 EKG.
POLICY
The use of pneumatic compression pumps in the home setting is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
The use of chest, trunk, head, or neck pneumatic compression pumps in the home setting for the treatment of lymphedema with or without involvement of the upper and/or lower limbs is considered investigational.
Pneumatic compression pumps for the treatment of other conditions/diseases, including, but not limited to venous ulcers is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Pneumatic compression pumps are considered medically appropriate if ANY ONE of the following are met:
Deep venous thromboembolism (DVT) prophylaxis for postoperative use in the home setting following major surgery (e.g., total hip arthroplasty, total knee arthroplasty, hip fracture surgery, open abdominal, or open-pelvic procedures) if ALL of the following are met:
Intermittent pneumatic device
No longer than 14 days
Documented contraindication to pharmacological agents (e.g., previous major bleeding [and previous bleeding risk similar to current risk], severe renal failure, concomitant antiplatelet agent, or surgical factors: history of or difficult-to-control surgical bleeding during the current operative procedure, extensive surgical dissection, and revision surgery)
As a treatment for lymphedema of one or more limbs if ANY ONE of the following are met:
Nonprogrammable pump, single or multi-chamber, for intractable lymphedema of one or more limbs for documented failure to respond to conservative measures such as limb elevation and use of compression garments
Programmable pump, single or multi-chamber if ALL of the following:
There is documented failure to respond to conservative measures such as limb elevation and use of compression garments
Documentation is present that the individual has characteristics that prevent satisfactory pneumatic compression performance from nonprogrammable pneumatic compression, such as significant scarring or contractures
IMPORTANT REMINDERS
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Insufficient quality and quantity of studies were found in the published literature to support the use of home pneumatic compression pumps in the head, neck, chest and trunk areas for treatment of lymphedema, and for treatment of venous ulcers.
SOURCES
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 VTE in orthopedic surgery patients. Retrieved January 10, 2019 from http://journal.publications.chestnet.org.
American College of Chest Physicians. (2022, November). Perioperative management of antithrombic therapy; an American College of Chest Physicians clinical practice guideline. Retrieved November 29, 2022 from http://www.chestnet.org.
American Venous Forum. (2022). The American Venous Forum, American Vein and Lymphatic Society for Vascular Medicine expert opinion consensus on lymphedema diagnosis and treatment. Retrieved November 29, 2022 from http://www.venousforum.org/resources/guidelines.
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 January 7, 2019 from https://www.veinforum.org/medical-allied-health-professionals/guidelines/.
BlueCross BlueShield Association. Evidence Positioning System. (4:2023). Pneumatic compression pumps for treatment of lymphedema and venous ulcers. (1.01.18). Retrieved December 14, 2023 from www.bcbsaoca.com/eps/. (19 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (4:2023). Postsurgical home use of limb compression devices for venous thromboembolism prophylaxis. (1.01.28). Retrieved December 14, 2023 from www.bcbsaoca.com/eps/. (22 articles and/or guidelines reviewed)
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 2 evidence)
Haykal, T., Zayed, Y., Dhillon, H., Miran, M. S., Kerbage, J., Bala, A., et al. (2022). Meta-Analysis of the role of intermittent pneumatic compression of the lower limbs to prevent venous thromboembolism in critically ill patients. The International Journal of Lower Extremity Wounds, 21 (1), 31–40, doi: 10.1177/1534734620925391. Abstract retrieved December 1, 2022 from PubMed database.
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.
Pavon, J.M., Adam, S.S., Razouki, Z.A., McDuffie, J.R., Lachiewicz, P.F., Kosinski, A.S., et al. (2016). Effectiveness of intermittent pneumatic compression devices for venous thromboembolism prophylaxis in high-risk surgical patients: a systematic review. Journal of Arthroplasty, 31 (2), 524-532. Abstract retrieved February 18, 2020 from PubMed database.
Ridner, S., Murphy, B., Deng, J., Kidd, N., Galford, E., Bonner, C., et al. (2012). A randomized clinical trial comparing advanced pneumatic truncal, chest, and arm treatment to arm treatment only in self-care of arm lymphedema. Breast Cancer Research & Treatment, 131 (1), 147-158. Abstract retrieved February 18, 2019 from PubMed database.
U. S. Food and Drug Administration. (2006, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K062818 (FlexiTouch®). Retrieved February 18, 2019 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Medical Technical Directory. (2018, November; last reviewed January 2023). Pneumatic compression for prevention of deep vein thrombosis following total knee arthroplasty. Retrieved December 14, 2023 from www.Hayesinc.com/subscribers. (63 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 6/1998
MOST RECENT REVIEW DATE: 2/8/2024
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