Cooling Devices Used in the Outpatient Setting

POLICY NUMBER

A.1.01.26

DESCRIPTION

Cooling devices use chilled water to decrease the local temperature of tissue. There are a variety of cooling devices available, ranging from gravity-fed devices that manually fill with iced water, to motorized units that both cool and circulate chilled water. These devices are typically used when ice packs would normally be applied (eg, after orthopedic surgical procedures).

Cold and Compression Therapy

Use of ice packs and various bandages and wraps following surgery or musculoskeletal and soft tissue injury is common. A variety of manually operated and mechanical continuous cooling devices are commercially available.

The standard postoperative treatment for musculoskeletal surgeries consists of cryotherapy (cold therapy) and various types of compressive wraps. Both ice packs (with or without additives to maintain temperature) and cooling devices can provide cryotherapy. Circulating cooling devices are designed to provide a constant low temperature, which might provide additional benefit compared with the more variable temperature achieved with the intermittent replacement of ice packs. Noncirculating cooling devices might also allow less variable cooling due to the larger volume of ice stored in the insulated tank and the use of circulated ice water.

Noncirculating Cooling Devices

The CryoCuff® and Polar Care Cub devices are examples of passive, noncirculating cooling devices. The CryoCuff device consists of an insulated container filled with iced water that is attached to a compressive cuff. When the CryoCuff container is raised, the water fills and pressurizes the cuff. The amount of pressure is proportional to the height of the container. When body heat warms the water, the cooler is lowered and water drained. The cooler is then raised above the affected limb, and cold water refills the compressive cuff. The Polar Care Cub unit 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.

Circulating Cooling Devices

In active, circulating cooling devices, a motorized pump circulates chilled water and may also provide pneumatic compression. For example, the AutoChill® device, which may be used with a CryoCuff, consists of a pump that automatically exchanges water from the cuff to the cooler, eliminating the need for manual water recycling. The Hot/Ice Thermal Blanket is another circulating cooling device. It consists of two rubber pads connected by a rubber hose to the main cooling unit. Fluid is circulated via the hose through the thermal blankets. The temperature of the fluid is controlled by the main unit and can be either hot or cold. The Game Ready™ Accelerated Recovery System is a circulating cooling device combined with a pneumatic component. The system consists of various soft wraps and a computer-control unit to circulate the water through the wraps and to provide intermittent pneumatic compression. The Hilotherm® Clinic circulates cooled water through preshaped thermoplastic polyurethane facial masks for use after different types of facial surgery. ThermaZone® provides thermal therapy with pads specific to various joints, as well as different areas of the head (front, sides, back, eyes). CTM™ 5000 and cTreatment are computer-controlled devices that provide cooling at a specific (11°C) and continuous temperature.

A large number of circulating and noncirculating cooling devices have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process since 1976 and are listed in the table below.

Cooling Devices Cleared by the U.S. Food and Drug Administration

POLICY

Circulating and noncirculating cooling devices are considered investigational.

Combination circulating cooling and compression (cryopneumatic) devices are considered investigational.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

2/2001: Approved by Medical Policy Advisory Committee (MPAC), Code Reference section completed, HCPCS E0218 added.

5/2/2002: Type of Service and Place of Service deleted.

8/16/2005: Policy title "Polar Care" renamed "Cooling Devices," Description and Policy sections revised to be consistent with BCBSA policy # 1.01.26, Code Reference section updated, HCPCS E0236 added.

4/25/2008: Policy reviewed, no changes.

12/10/2009: Policy Exclusions revised to include FEP verbiage, HCPCS code E1399 added to Non-Covered Codes Table.

05/17/2011: Policy reviewed; no changes to policy statement. Removed outdated references from the Sources section.

03/02/2012: Policy reviewed. "Used in the Outpatient Setting" added to the policy title.

05/08/2013: Policy description updated. Added the following policy statement: Combination active cooling and compression (cryopneumatic) devices are considered investigational. Deleted the Federal Employee Program (FEP) policy exception as this device is also considered not medically necessary for FEP members.

06/05/2014: Policy reviewed; description updated. Policy statement unchanged.

07/13/2015: Code Reference section updated for ICD-10.

09/10/2015: Policy description updated regarding devices. Policy statements unchanged. Policy guidelines section updated to add investigative definition.

05/31/2016: Policy number A.1.01.26 added.

11/04/2016: Policy reviewed; no changes.

10/25/2017: Policy description updated regarding noncirculating and circulating devices. Policy section updated to change "active" to "circulating" and "passive" to "noncirculating."

04/06/2018: Policy description updated regarding cold and compression therapy. Policy statements unchanged.

12/27/2018: Code Reference section updated to revise code description for HCPCS code E0218, effective 01/01/2019.

04/03/2019: Policy description updated regarding devices. Policy statements unchanged.

04/14/2020: Policy description updated regarding devices. Policy statements unchanged.

05/21/2021: Policy reviewed; no changes.

04/26/2022: Policy description updated regarding devices. Policy statements unchanged.

04/11/2023: Policy description updated regarding devices. Policy statement updated to change "not medically necessary" to "investigational."

04/11/2024: Policy description updated regarding devices. Policy statements unchanged.

04/24/2025: Policy description updated regarding devices. Policy statements unchanged.

01/01/2026: Code Reference section updated to add new HCPCS codes C9810 and C9817.

SOURCE(S)

Blue Cross Blue Shield Association policy # 1.01.26

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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