Medical Policy: 01.01.18
Original Effective Date: March 2011
Reviewed: October 2016
Revised: November 2014
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Cooling devices may also be referred to as cold therapy units, cryounits or cryotherapy machines. Cooling devices use chilled water to decrease the local temperature of tissue. There are a variety of devices available, ranging from gravity-fed devices that are manually filled with iced water, to motorized units that both cool and circulate the chilled water. These devices are typically used when ice packs would normally be applied, e.g., after musculoskeletal or soft tissue injuries and orthopedic surgical procedures to reduce inflammation, pain and swelling.
Cold and/or compression therapy following surgery or musculoskeletal and soft tissue injury has long been accepted in the medical field as an effective tool for reducing inflammation, pain and swelling. Ice packs and various bandages and wraps are commonly used. In addition, a variety of continuous cooling devices are commercially available and can be broadly subdivided into those providing manually operated passive cold therapy and those providing active cold therapy using a mechanical device.
Passive cold therapy devices operate by gravity or a hand pump with no battery or electricity used. Generally they consist of a cuff or wrap and a cooler. When the container is raised, the water fills and pressurizes the cuff and compresses the joint. The amount of pressure is proportional to the height of the container. When body heat warms the water, the cooler is lowered and the water drains out. The cooler is then raised above the affected limb and cold water refills the compressive cuff.
Available passive or gravity controlled cold therapy devices that provide cooling and compression inclue, but are not limited to:
Active cooling devices include pneumatic or mechanical pumps that may be battery or electric operated. The intended function of the pump is to provide cyclical compression and cooling to the affected area. The purpose of the compression is to remove fluid and decrease edema while providing the cooling. The devices generally consist of two basic parts: a wrap or wrap system that is designed to cover specific areas of the body; and a control unit, which is filled with ice and water. The control unit or pump circulates the cooled water through the wraps to the affected area. The devices may also contain a cooler or refrigeration component. Some of these devices are also designed to provide heat therapy.
Available active cold therapy devices that operate by battery or electric powered pump that provide cooling and compression include, but are not limited to:
Based on review of the peer reviewed medical literature most of the published randomized studies of passive cooling devices failed to adequately describe the cooling regimens or include the relevant control groups of standard icepack treatment. When passive cooling devices and ice packs were used with the same regimen, no differences in health outcomes were observed. Currently available evidence is insufficient to determine whether continuous cooling devices result in improved health outcomes when compared with usual ice pack exchange in the home environment.
For combination active cryotherapy/compression (cryopneumatic) devices, two recent studies reported that narcotic use is decreased and that patient satisfaction is higher. However, no other outcome measures were improved, and one of the studies suffered from a low follow-up rate. Additional studies are needed to permit conclusions regarding the effect of this technology with greater certainty.
Although cold therapy has a long history as therapeutic entity in the treatment of soft tissue injury and in postoperative rehabilitation, the literature is conflicting on the efficacy of this treatment. In addition, there is insufficient evidence in the published, peer-reviewed scientific literature to demonstrate that the use of specialized devices that provide cooling or cooling and compression have a clinical benefit over the conventional, intermittent application of ice packs and wraps. Cooling devices, both passive or active pump controlled devices, that provide cooling or cooling and compression have no additional clinical utility or impact on health outcomes than the use of ice or compression wraps. It does appear that such devices may offer ease of application and are more convenient. Overall, the available literature is insufficient to document that the use of passive or active cooling systems is associated with a benefit beyond convenience, these devices are considered not medically necessary.
A large number of active and passive cooling devices have received U.S. Food and Drug Administration (FDA) 510(k) clearance since 1976.
Active and passive cooling devices are considered not medically necessary for all indications.
Combination active cooling and compression devices (cryopneumatic) devices are considered not medically necessary for all indications.
There is insufficient evidence in the peer reviewed literature to demonstrate that the use of specialized devices that provide cooling and compression have a clinical benefit or impact on health outcomes over the conventional, intermittent application of icepacks and wraps. The available literature is insufficient to document that the use of active, passive or combined cooling systems are associated with a benefit beyond convenience and therefore these devices are considered not medically necessary.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
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