The use of cooling devices has been utilized for the treatment of pain and swelling after trauma and surgery and for musculoskeletal and other conditions.  Continuous cooling devices can be broadly subdivided into those providing passive cold therapy and those providing active cold therapy using a mechanical device. The document addresses both passive and active cooling devices.

This document also addresses the use of devices that combine the ability to heat and cool the body, with the same goal as stated above, to relieve pain and swelling due to trauma, surgery and other conditions.

Not Medically Necessary:

The use of active or passive cooling devices is considered not medically necessary in the postoperative care of patients undergoing musculoskeletal surgery.

Investigational/Not Medically Necessary:

All other applications of passive cooling devices, including but not limited to their use for nonoperative musculoskeletal injuries, are considered investigational/not medically necessary.

The use of active cooling devices with additional pneumatic compression is considered investigational/not medically necessary, for all indications, including, but not limited to, the post operative care of patients.

The use of active or passive devices that combine cooling and heating is considered investigational/not medically necessary, for all indications, including, but not limited to the use of the VitalWrap^TM system.

The standard postoperative treatment of musculoskeletal surgeries consists of icepacks (cryotherapy) and various types of compressive wraps to control both pain and swelling. To document the effectiveness of various cooling devices in comparison to standard methods of cryotherapy, randomized controlled trials are required. The goal of such studies is to demonstrate a greater likelihood of benefit compared to conventional cryotherapy when used in the outpatient setting. Both conventional cryotherapy and the passive cooling devices are essentially designed to provide cold therapy, with the primary difference being that water recirculation is more convenient with passive cooling devices. To document a medical benefit of passive devices (i.e., beyond patient or medical staff convenience), the trial design must control the number of exchanges of ice bags and episodes of water recirculation. In contrast, active cooling devices are designed to provide a steady low temperature, which might provide a unique benefit compared to the more variable temperature achieved with ice packs or passive cooling devices. Benefit is typically focused on pain control and swelling, and trials investigating these devices need to focus in these aspects of care. The discussion below focuses only on randomized studies.

Passive Cooling Devices

Schroder and Passler compared the CryoCuff® device to traditional ice therapy in 44 inpatients that had undergone repair of the anterior cruciate ligament (ACL) (Schroder, 1994). Those receiving ice therapy received an ice bag three times per day postoperatively, while the CryoCuff group used the device. While those randomized to the CryoCuff group reported significant decreases in pain, swelling and analgesic use, it was not reported how frequently the cold water was recirculated in the device as compared to the three dimes daily ice pack changes. Additionally, the inpatient setting used in this study is not relevant to this policy, particularly since in this German study, patients were hospitalized for 14 days. Whitelaw and colleagues reported on the results of a trial that randomized 102 patients undergoing knee arthroscopy in the outpatient setting to receive either a CryoCuff device or traditional ice therapy (Whitelaw, 1995). The number of exchanges of ice packs and water recirculation was not reported. There was no significant difference in average pain assessment, while those in the CryoCuff group reported decreased pain medication compared to the control group. Healy and colleagues reported that the CryoCuff device provided no benefit to pain control or swelling compared to ice packs in a randomized trial of 76 patients (105 knees) undergoing total knee arthroplasty (Healy, 1994). No data was provided on the number of ice pack exchanges, although the water was recirculated in the CryoCuff device every one to four hours. The duration of therapy, and whether or not it was applied in the inpatient or outpatient setting is not clear from the published article. Edwards and colleagues studied the outcomes of 71 patients undergoing ACL reconstruction who were randomized to receive either CryoCuff therapy with ice water, CryoCuff therapy with room temperature water or no cold therapy (Edwards, 1996). Therefore, this trial did not include the relevant control group of patients treated with conventional ice packs. Nevertheless, there were no significant differences in analgesic use or pain assessment among the three groups, including the group that received no cold therapy. Levy and colleagues also compared the outcomes in a trial randomizing 80 patients (100 knees) undergoing total knee arthroplasty to receive either passive cold therapy with a CryoCuff device or no cold therapy (Levy, 1993). The CryoCuff group reported a significant decrease in blood loss and mild decrease in analgesic requirements. Similar to the Edwards trial, this trial did not include the relevant control group of ice packs. Another randomized trial by Brandsson suffers from the same limitation; in this study of 50 patients undergoing ACL repair, there was no group who received standard therapy with ice packs (Brandsson, 1996).

In summary, the available scientific literature is insufficient to document that the use of passive cooling systems is associated with a greater likelihood of benefit compared to standard ice packs. Many of the published randomized studies failed to include the relevant control group of standard ice packs. Studies that did include a control group of standard ice packs reported inconsistent results (Healy, 1994), and some studies reported no significant benefit of passive cooling devices compared to no cold therapy (Edwards, 1996).

Active Cooling Devices

In contrast, a literature search identified only one randomized study that compared the outcomes of an active cooling device with traditional ice therapy. Konrath and colleagues reported on the results of a trial that randomized 103 patients undergoing ACL reconstruction to one of four different postoperative cold therapy strategies; 1&2) active cooling with a Polar Care™ pad set at a temperature of 40 to 50 degrees or 70 to 80 degrees centrigrade, respectively; 3) ice packs; and 4) no cold therapy (Konrath, 1996). Both the water in the Polar Care pad and the ice packs were changed every 4 hours. The length of hospital stay, range of motion at discharge, use of oral and intramuscular pain medicine and drain output were not significantly different between groups. These results suggest that the active cooling device is similar to ice packs, but there is inadequate evidence to demonstrate that the active cooling device is associated with a greater likelihood of benefit. Several randomized studies compared active cooling devices to no cold therapy, which are not relevant to the documentation of benefit compared to standard therapy with ice packs (Cohn, 1989; Barber, 1998; Dervin, 1998).

Other Cooling Devices and Indications

A literature search did not identify any published articles focusing on the use of active or passive cooling devices equipped with pneumatic compression. Similarly there were no published articles focusing on the role of cooling devices in nonsurgical settings, i.e., for the treatment of sprains or strains, or chiropractic treatments.

Combined Cooling/Heating Devices

The available literature regarding either active or passive devices that combine the ability to provide cold and heat therapy is currently insufficient to allow conclusions regarding their effectiveness. At this time only one such device is available, the VitalWrap system.  There is no available data in the published peer-reviewed literature regarding this active cooling/warming device in comparison to other methods of cooling or heating.  Data addressing any incremental benefit over standard therapy modalities from the use of these types of devices is required to assess their efficacy in treating any type of condition.

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. Continuous cooling devices can be broadly subdivided into those providing passive cold therapy, and those providing active cold therapy using a mechanical device. For example, the CryoCuff device (Aircast, Inc., Boca Raton Florida) and the Polar Care Cub™ devices ( Breg, Inc., Vista CA.) are examples of passive cooling devices. The CryoCuff device consists of an insulated container filled with cold water that is attached to a compressive cuff. When the 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 the water drains out. 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 over the injury with elastic straps, which may also provide tension. The pads are attached to a built in hand pump which circulates the water through the pads at the same time as increasing the compression around the joint. In active (mechanical) devices, a motorized pump both circulates cold water and may also provide pneumatic compression. For example, the AutoChill® device(Aircast, Inc., Boca Raton Florida)  , which may be used in conjunction with a CryoCuff, consists of a pump that automatically exchanges water from the cuff to the cooler, eliminating the needs for manual water recycling. The Hot/Ice Thermal Blanket™ (Thermo Temp Inc., Tampa, Florida) is another example of an active cooling device, which consists of two rubber pads connected by a rubber hose to the main cooling unit. Fluid is then 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 (Game Ready Inc., Berkeley, CA) is an example of an active cooling device combined with a pneumatic component. The system consists of various soft wraps and a computer controlled control unit to circulate the water through the wraps.

The VitalWrap™ (VitalWear Inc. South San Francisco, CA) is an active heating/cooling device that allows the user to circulate either hot or cold fluid through the system.  The VitalWrap system consists of a bladder filled body wrap/pad, tubing, and a reservoir/pump device.  Cooled or heated water may be added to the pump reservoir and then circulated through the tubing to the body wrap/pad and then back to the reservoir.  The benefits of this type of device above other cooling or heating methods have not been established at this time.

Active Cooling or Heating Device: a device that provides cooling or heating with the use of mechanical circulation of the thermal medium from a reservoir that may cool or heat the medium before returning it to the site of injury

Passive Cooling or Heating Device: a device that provides cooling or heating without the benefit of mechanical circulation of the thermal medium

The following codes for treatments and procedures applicable to this policy are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Not Medically Necessary:

HCPCS

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary:

For the procedure codes listed above for all other diagnoses not listed; or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

When services are also Investigational/Not Medically Necessary:

HCPCS

ICD-9 Diagnosis

1. Barber FA, McGuire DA, Click S.  Continuous-flow cold therapy for outpatient anterior cruciate ligament reconstruction.  J Arthroscopy Rel Surg. 1998; 14:130-135.
2. Brandsson S, Rydgren B, Hedner T, et al.  Postoperative analgesic effects of an external cooling system and intra-articular bupivacaine/morphine after arthroscopic cruciate ligament surgery.  Knee Surg Sports Traumatol Arthroscopy. 1996; 4:200-205.
3. Cohn BT, Draeger RI, Jackson DW.  The effects of cold therapy in the postoperative management of pain in patients undergoing anterior cruciate ligament reconstruction.  Am J Sports Med. 1989; 17:344-349.
4. Dervin GF, Taylor DE, Keene GCR. Effects of cold and compression dressings on early postoperative outcomes for the arthroscopic anterior cruciate ligament reconstruction patient.  J Orthop Sports Phys Ther. 1998; 27:403-406.
5. Healy WL, Seidman J, Pfeifer BA, Brown DG.  Cold compressive dressing after total knee arthroplasty.  Clin Orthop. 1994; 299:143-149.
6. Edwards DJ, Rimmer M, Keene, GCR. The use of cold therapy in the postoperative management of patients undergoing arthroscopic anterior cruciate ligament reconstruction.  Am J Sports Med. 1996; 24:193-195.
7. Konrath GA, Lock T, Goitz HT, Scheidler J. The use of cold therapy after anterior cruciate ligament reconstruction.  Am J Sports Med. 1996; 24:629-633.
8. Levy AS, Marmar E.  The role of cold compression dressings in the postoperative treatment of total knee arthroplasty.  Clin Orthop Rel Res. 1993; 297:174-178.
9. Schroder D, Passler HH.  Combination of cold and compression after knee surgery.  A prospective randomized trial.  Knee Surg Sports Traumatol Arthrosc. 1994; 2:158-165.
10. Whitelaw GP, DeMuth KA.  Demos HA, et al.  The use of the Cryo/cuff versus ice and elastic wrap in the postoperative care of knee arthroscopy patients.  Am J Knee Surg. 1995; 8:28-31.

Aircast Cryo/Strap®
AutoChill® Device
Cooling Devices
Cryocuff®
Game Ready^TM  Accelerated Recovery System
Hot/Ice Thermal Blanket^TM
Polar Care Cub^TM
Polar Pack®
VitalWrap™

The use of specific product names is illustrative 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.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by an means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

©CPT Only - American Medical Association