The use of cold therapy, active or passive, continuous or intermittent, with or without pneumatic compression, using, but not limited to, described devices, offers no substantive benefit over conventional management and is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

 

For contracts without primary coverage criteria, the use of cold therapy, active or passive, continuous or intermittent, with or without pneumatic compression, using, but not limited to, described devices is considered not medically necessary.

The standard postoperative treatment of musculoskeletal surgeries consists of ice packs and various types of compressive wraps. Both ice packs 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. Therefore, to document a benefit beyond 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. The discussion below focuses only on randomized studies.

 

Schroder compared the CryoCuff device to traditional ice therapy in 44 patients who had undergone repair of the anterior cruciate ligament (ACL). Those receiving ice therapy received an ice bag three times per day postoperatively. 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. Additionally, the inpatient setting 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.  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. 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.  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. 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. 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.  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. 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.  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.

 

In summary, the available scientific literature is insufficient to document that the use of passive cooling systems is associated with a benefit beyond convenience, and thus these devices are considered not medically necessary. 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, and some studies reported no significant benefit of passive cooling devices compared to no cold therapy.

 

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 centigrade, respectively; 3.) ice packs; and 4.) no cold therapy.  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 compared to ice packs, there is a benefit beyond convenience. 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.

 

A literature search did not identify any published articles focusing on the use of active 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.

 

While there is no national coverage decision for Medicare, cooling devices are addressed in DMERC policy. Last reviewed in 7/04, the DMERC policy reads as follows:

 

"A device in which ice water is put in a reservoir and then circulated through a pad by means of gravity is not considered durable medical equipment (DME). Other devices (not all-inclusive which are also not considered to be DME are: single use packs which generate cold temperature by a chemical reaction; packs which contain gel or other material which can be repeatedly frozen; simple containers into which ice water can be placed. All of these types of devices must be coded A9270 if claims are submitted to the DMERC."

 

"Code E0218 describes a device which has an electric pump that circulates cold water through a pad ...A water circulating cold pad with pump (E0218) will be denied as not medically necessary."

 

 

 

 

 

 

 

 

 

 

 

 

 

 

One study assessing the use of the Game Ready device was identified. Kraeutler et al compared the Game Ready shoulder wrap to standard icing in an RCT of 46 patients who had undergone rotator cuff repair or subacromial decompression (Kraeutler, 2015). Patients were instructed to apply the cryotherapy every other hour for the first 3 days and 2 to 3 times a day until the follow-up visit at 7 to 10 days. Analysis of patient diaries showed no significant differences in average pain, worst pain, and morphine equivalent dosage between the 2 groups on any day during the week after surgery. Post hoc power analysis showed that 13 patients per group would provide sufficient power to detect a 25 mm (out of 100) difference in VAS scores between the 2 groups.