Medical policy: Cooling Devices Used in the Outpatient Setting

Policy number: MP 6.040

Effective date: 9/1/2026

Policy

Circulating and noncirculating cooling devices are considered investigational.

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

There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Cross-references:

• MP 6.026 Durable Medical Equipment (DME) and Supplies

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO - Refer to FEP Medical Policy Manual.

Description/Background

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 (e.g., 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® Cube 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 Cube 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 (2) 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 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, other cuffs may be attached for uses outside 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).

Regulatory status

A large number of circulating and noncirculating cooling devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process since 1976 and are listed in Table 1.

FDA product code: ILO.

Table 1. Cooling Devices Cleared by the FDA

Rationale

Summary of evidence

For individuals who have pain and/or swelling after knee surgery who receive a cooling device, the evidence includes a systematic review, several randomized controlled trials (RCTs), and a case-control study. Relevant outcomes are symptoms, functional outcomes, medication use, and resource utilization. Studies on manually operated passive noncirculating cooling devices were limited by the control condition used in the trials. Studies that used either a no-icing control or infrequent ice applications did not provide sufficient evidence of comparative efficacy. Other studies provided no information on the frequency of ice changes, limiting interpretation of the results. Several randomized trials have compared active circulating cooling devices with standard intermittent icing or cold packs, and results have demonstrated mixed benefits, with 1 trial (N=100) finding acute pain reduction with a cooling device and 2 of the larger trials finding no significant benefit of the continuous cooling devices. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have pain and/or swelling after shoulder surgery who receive a cooling device, the evidence includes 3 RCTs. Relevant outcomes include symptoms, functional outcomes, medication use, and resource utilization. Evidence from 2 RCTs found that use of compressive cryotherapy produced no significant reduction in pain or medication use compared with standard ice wrap. One RCT found a reduction in opioid use with cryopneumatic therapy compared with standard of care, but there was no difference in pain scores between groups, and diversity in the icing methods in the control group prohibit conclusions regarding the efficacy of cryopneumatic therapy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have pain and/or swelling after facial surgery who receive a cooling device, the evidence includes several small RCTs and a pilot study. Relevant outcomes include symptoms, functional outcomes, medication use, and resource utilization. There have been mixed results regarding the intervention’s efficacy in reducing neurologic problems as well as improving eye mobility, diplopia, mandibular functioning, and mouth opening compared with conventional cooling regimens. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

N/A

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as permitted by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the member’s benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement.

Investigational; therefore, not covered:

*E1399 [when used to bill for a combination active cooling and compression (cryopneumatic) device or when used to bill for a noncirculating cooling device]

References

1. Schröder D, Pässler HH. Combination of cold and compression after knee surgery. A prospective randomized study. Knee Surg Sports Traumatol Arthrosc. 1994; 2(3): 158-65. PMID 7584198
2. 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(1): 28-30; discussion 30-1. PMID 7866800
3. Healy WL, Seidman J, Pfeifer BA, et al. Cold compressive dressing after total knee arthroplasty. Clin Orthop Relat Res. Feb 1994; (299): 143-6. PMID 7907012
4. Liang Z, Ding Z, Wang D, et al. Cryotherapy for Rehabilitation After Total Knee Arthroplasty: A Comprehensive Systematic Review and Meta-Analysis. Orthop Surg. Dec 2024; 16(12): 2897-2915. PMID 39402664
5. Thienpont E. Does advanced cryotherapy reduce pain and narcotic consumption after knee arthroplasty? Clin Orthop Relat Res. Nov 2014; 472(11): 3417-23. PMID 25059851
6. Woolf SK, Barfield WR, Merrill KD, et al. Comparison of a continuous temperature-controlled cryotherapy device to a simple icing regimen following outpatient knee arthroscopy. J Knee Surg. Jan 2008; 21(1): 15-9. PMID 18300666
7. Ruffilli A, Buda R, Castagnini F, et al. Temperature-controlled continuous cold flow device versus traditional icing regimen following anterior cruciate ligament reconstruction: a prospective randomized comparative trial. Arch Orthop Trauma Surg. Oct 2015; 135(10): 1405-10. PMID 26141535
8. Ruffilli A, Castagnini F, Irina F, et al. Temperature-Controlled Continuous Cold Flow Device after Total Knee Arthroplasty: A Randomized Controlled Trial Study. J Knee Surg. Sep 2017; 30(7): 675-681. PMID 27903009
9. Coviello M, Abate A, Ippolito F, et al. Continuous Cold Flow Device Following Total Knee Arthroplasty: Myths and Reality. Medicina (Kaunas). Oct 27 2022; 58(11). PMID 36363493
10. Quesnot A, Mouchel S, Salah SB, et al. Randomized controlled trial of compressive cryotherapy versus standard cryotherapy after total knee arthroplasty: pain, swelling, range of motion and functional recovery. BMC Musculoskelet Disord. Feb 28 2024; 25(1): 182. PMID 38419032
11. Su EP, Penna M, Boettner F, et al. A prospective, multi-center, randomized trial to evaluate the efficacy of a cryopneumatic device on total knee arthroplasty recovery. J Bone Joint Surg Br. Nov 2012; 94(11 Suppl A): 153-6. PMID 23118406
12. Waterman B, Walker JJ, Swaims C, et al. The efficacy of combined cryotherapy and compression compared with cryotherapy alone following anterior cruciate ligament reconstruction. J Knee Surg. May 2012; 25(2): 155-60. PMID 22928433
13. Murgier J, Cailliez J, Wagryn M, et al. Cryotherapy With Dynamic Intermittent Compression Improves Recovery From Revision Total Knee Arthroplasty. J Arthroplasty. Sep 2017; 32(9): 2788-2791. PMID 28465126
14. Kraeutler MJ, Reynolds KA, Long C, et al. Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression. J Shoulder Elbow Surg. Jun 2015; 24(6): 854-9. PMID 25825138
15. Noyes MP, Denard PJ. Continuous Cryotherapy vs Ice Following Total Shoulder Arthroplasty: A Randomized Control Trial. Am J Orthop (Belle Mead NJ). Jun 2018; 47(6). PMID 29979799
16. Khan M, Phillips SA, Mathew P, et al. Cryo-Pneumatic Compression Results in a Significant Decrease in Opioid Consumption After Shoulder Surgery: A Multicenter Randomized Controlled Trial. Am J Sports Med. Sep 2024; 52(11): 2860-2865. PMID 39165152
17. 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. PMID 22626630
18. Rana M, Gellrich NC, Ghassemi A, et al. Three-dimensional evaluation of postoperative swelling after third molar surgery using 2 different cooling therapy methods: a randomized observer-blind prospective study. J Oral Maxillofac Surg. Aug 2011; 69(8): 2092-8. PMID 21496998
19. Rana M, Gellrich NC, Joos U, et al. 3D evaluation of postoperative swelling using two different cooling methods following orthognathic surgery: a randomised observer blind prospective pilot study. Int J Oral Maxillofac Surg. Jul 2011; 40(7): 690-6. PMID 21411291
20. 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. Jul 29 2013; 14: 238. PMID 23895539
21. Srivastava AK, Godin J, Srivastava A, et al. American Academy of Orthopaedic Surgeons Clinical Practice Guideline Summary of Surgical Management of Osteoarthritis of the Knee. J Am Acad Orthop Surg. Dec 15 2023; 31(24): 1211-1220. PMID 37883429
22. McGrory BJ, Weber KL, Jessevar DS, et al. Surgical Management of Osteoarthritis of the Knee: Evidence-based Guideline. J Am Acad Orthop Surg. Aug 2016; 24(8): e87-93. PMID 27355286