Medical Policy: 01.01.18
Original Effective Date: March 2011
Reviewed: October 2015
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. These devices may be passive or active and operate by gravity or the use of mechaical or pneumatic pump. 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.
Passive Cooling Devices
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:
- Cryo/Cuff™ (Aircast®, Summit, NJ): This device has a gravity-controlled system.
- The Polar Care Cub unit (BREG, Inc., McKinney, TX) consists of pads held in place with elastic straps, which may also provide compression. The pads are attached to a built-in hand pump that circulates the water through the pads at the same time as increasing the compression around the joint.
Active Cooling Device
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:
- AutoChill® system (Aircast®, Summit, NJ: This device is an accessory to the CryoCuff® system that utilizes an electronic pump in order to continuously cycle water between cooler and cuff.
- BioCryo Cold Compression System (Bio Compression Systems, Inc., Moonachie, New Jersey): This device includes a gradient, sequential, pneumatic compression pump.
- DeRoyal® Cold Therapy Unit (DeRoyal Industries, Powell, TN): Includes pump motor that circulates water between unit bucket and cooling blanket.
- Game Ready™ Accelerated Recovery System (CoolSystems, Inc., Berkeley, CA): This device contains an electric or battery-run pump.
- Iceman Cold Therapy unit (DJO Incorporated Inc., Vista, CA): This device includes pad and electric pump to circulate the fluid.
- Nanotherm2™ (ThermoTek, Carrollton, TX): This devices includes pneumatic pump and provides heating, cooling and compression therapies.
- Polar Care 500, Polar Care 300 (BREG, Inc., McKinney, TX): This device includes a pad and battery/electric pump that is used to circulate the water.
- VitalWrap System® (VitalWear Inc., South San Francisco, CA): This device provides heating, cooling, and compression therapies. The device includes a control unit, tubing set, and a thermal fabric wrap. The control unit, which includes a fluid reservoir, manages the temperature of water used by the system to supply heat or cold to the fabric wrap that is attached to the body.
- Vascutherm2™ (ThermoTek, Carrollton, TX): Includes pneumatic pump and provides heating, cooling and compression therapies. The device also includes a deep vein thrombosis (DVT) mode–this is a compression (or air)-only mode, that is intended to prevent DVT.
For active cryotherapy/cryopneumatic compression 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 study is 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 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 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.
Practice Guidelines and Position Statements
- No guidelines or statements were identified.
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.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- E0218 Water circulating cold pad with pump
- E0236 Pump for water circulating pad
- Bleakley C, O'Connor S, Tully M et al. The price study (protection rest ice compression elevation): design of a randomised controlled trial comparing standard versus cryokinetic ice applications in the management of acute ankle sprain. BMC Musculoskelet Disord 2007; 19(8):125.
- Woolf SK, Barfield WR, Merrill KD et al. Comparison of continuous temperature-controlled cryotherapy device to a simple icing regimen following outpatient knee arthroscopy. J Knee Surg 2008; 21(1):15-9.
- Adie S, Naylor J, Harris IA. Cryotherapy after total knee arthroplasty: a systematic review and meta-analysis of randomized controlled trials. J Arthroplasty 2010; 25(5):709-15.
- Adie S, Kwan A, Naylor JM, et al. Cryotherapy following total knee replacement. Cochrane Database Syst Rev. 2012 Sep 12;9: CD007911.
- Waterman B, Walker JJ, Swaims C, et al. The efficacy of combined cryothearpy and compression compared with cryotherapy alone following anterior cruciate ligament reconstruction. J Knee Surg. 2012 May;25(2):155-60.
- Holm B, Husted H, Kehlet H, Bandholm T. Effect of knee joint icing on knee extension strength and knee pain early after total knee arthroplasty: a randomized cross-over study. Clin REhabil. 2012 Aug;26(8):716-23.
- Su EP, Perna M, Boettner F et al. A prospective, multi-center, randomiszed trial to evaluate the efficacy of a cryopneumatic device on total knee arthroplasty recovery. J Bone Joint Surg Br 2012; 94(11 Suppl A):153-6.
- Adie S, Naylor JM, Harris IA. Cryotherapy After Total Knee Arthroplasty: A Systemic Review and Meta-Analysis of Randomized Controlled Trails. J Arthroplasty. 2010;25(5):709-715
- Block Jon. Cold and Compression in the Management of Musculoskeletal Injuries and Orthopedic Operative Procedures: A Narrative Review. Open Access Journal of Sports Medicine 2010:1 105-113
- Modabber A, Rana M, Ghassemi A. et. al. Three dimensional Evaluation of Postoperative Swelling in Treatment of Zygomatic Bone Fractures Using Two Different Cooling Therapy Methods: A Randomized, Observer-Blind, Prospective Study. Trials. 2013;14:238
- Rana M, Gellrich NC, Von See C, et. al. 3D Evaluation of Postoperative Swelling in Treatment of Bilateral Mandibular Fractures Using 2 Different Cooling Therapy Methods: A Randomized Observer Blind Prospective Study. J Craniomaxillofac Surg. Jan 2013;41(1);e17-23.
October 2015 - Annual Review, Policy Renewed
November 2014 - Annual Review, Policy Revised
January 2014 - Annual Review, Policy Renewed
February 2013 - Annual Review, Policy Renewed
February 2012 - Annual Review, Policy Renewed
March 2011 - New Topic, New Policy
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.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.