Latest Review Date: March 2024

Category: Durable Medical Equipment (DME)                                                                    

POLICY:

Active (circulating) and passive (noncirculating) cooling devices used in the home setting are considered not medically necessary.

Active (circulating) and passive (noncirculating) heating devices (including but not limited to: heating pads, moist electric heating pad or water circulating heat pad with pump,) are not medically necessary and are considered a convenience item.

Active (circulating) or passive (noncirculating) devices that combine cooling and heating are not medically necessary.

Intermittent compression devices which incorporate cold or heat therapy (cryopneumatic) such as the Game Ready® device, are considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

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 are manually filled with iced water, to motorized units that both cool and circulate the 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.

Non-circulating Cooling Devices

The CryoCuff® and the Polar Care Cub devices are examples of passive cooling devices. The CryoCuff device consists of an insulated container filled with iced 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 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 cooling devices, a motorized pump circulates chilled water and may also provide pneumatic compression. For example, the AutoChill® device, 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 need for manual water recycling. The Hot/Ice Thermal Blanket is another example of an active cooling device. It consists of 2 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 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 (11o C) and continuous temperature.

KEY POINTS:

This evidence has been updated with a literature review using the PubMed database. The most recent literature update was performed through January 15, 2024.

Summary of Evidence

For individuals who have pain and/or swelling after knee surgery who receive a cooling device, the evidence includes systematic reviews, several RCTs, and a case-control study. Relevant outcomes are symptoms, functional outcomes, medication use, and resource utilization. Studies that used either a no-icing control or infrequent ice applications do not provide sufficient evidence of comparative efficacy. Other studies have 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 2 RCTs. Relevant outcomes include symptoms, functional outcomes, medication use, and resource utilization. Evidence found that use of compressive cryotherapy produced no significant reduction in pain or medication use compared with the standard ice wrap. 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 motility, diplopia, mandible 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.

Practice Guidelines and Position Statements:

American Academy of Orthopaedic Surgeons

In 2022, the American Academy of Orthopaedic Surgeons updated the 2016 guidelines on the surgical management of osteoarthritis of the knee after knee arthroplasty. The 2016 guideline statement, “Moderate evidence supports that cryotherapy devices after knee arthroscopy (KA) do not improve outcomes” was not modified in the 2022 update. Did not revisit several prior recommendations including cryotherapy devices.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

AutoChill®, Cooling Devices, CryoCuff®, Hot/Ice Thermal Blanket, Polar Care Cub, VitalWrap™, heating pads, circulating water heating pads, moist electric pad, Vascutherm Compression Therapy, Hilotherm® cooling face mask, ThermaZone®, CTM™ 5000 , cTreatment, Game Ready®, Game Ready GRPro 2.1, Polar Care Wave, Ice Compression First, Duo, Moove Systems, Armory Motion, Cryo-Thermo Compression Device, Cold/Hot Compression

APPROVED BY GOVERNING BODIES:

A large number of circulating and non-circulating cooling and heating devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process since 1976.

Table 1. Cooling Devices Cleared by the US Food and Drug Administration

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

CPT                           

HCPCS         

REFERENCES:

1. 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).
2. Gatewood CT, Tran AA, Dragoo JL. The efficacy of post-operative devices following knee arthroscopic surgery: a systematic review. Knee Surg Sports Traumatol Arthrosc. Feb 2017;25(2):501-516
3. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
4. 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):854-859.
5. McGrory BJ, Weber KL, Jevsevar DS, et al. Surgical Management of Osteoarthritis of the Knee: Evidence-based Guideline. J Am AcadOrthop Surg. Aug 2016; 24(8): e87-93.
6. 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.
7. Murgier J, Cailliez J, Wargny M, et al. Cryotherapy with dynamic intermittent compression improves recovery from revision total knee arthroplasty. J Arthroplasty. Sep 2017; 32(9):2788-2791.
8. Noyes MP, Denard PJ. Continuous Cryotherapy vs Ice Following Total Shoulder Arthroplasty: A Randomized Control Trial. Am J Orthop (Belle Mead NJ). 2018 Jun;47(6). doi: 10.12788/ajo.2018.0045.
9. 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):690-696.
10. 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 2013; 41(1):e17-23.
11. 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.
12. 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):1405-1410.
13. Ruffilli A, Castagnini F, Traina 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.
14. 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.
15. Su EP, Perna M, Boettner F, et al. A prospective, multi-center, randomised 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):153-156.
16. Thienpont E. Does advanced cryotherapy reduce pain and narcotic consumption after knee arthroplasty? Clin Orthop Relat Res. Nov 2014; 472(11):3417-3423.
17. Waterman B WJ, Swaims C, et al. The efficacy of combined cryotherapy and compression compared with cryotherapy alone following anterior cruciate ligament reconstruction. J Knee Surg. 2012; 25(2):155-160.
18. Weber KL, Jevsevar DS, McGrory BJ. AAOS Clinical Practice Guideline: Surgical Management of Osteoarthritis of the Knee: Evidence-based Guideline. J Am Acad Orthop Surg. 2016 Aug; 24 (8)

POLICY HISTORY:

Medical Policy Group, July 2009 (3)

Medical Policy Administration Committee, August 2009

Available for comment August 10-September 3, 2009

Medical Policy Group, September 2009 (1)

Medical Policy Administration Committee, September 2009

Available for comment September 4-October 19, 2009

Medical Policy Group, December 2010

Medical Policy Group, March 2011

Medical Policy Group, February 2012

Medical Policy Group. April 2013 (4): 2013 updates to Key Points and References. Reference to policy 123 was added for cyropneumatic devices, no policy changes made.

Medical Policy Panel April 2104

Medical Policy Group April 2014 (4); Update to Description, Key Points, Key Words, Approved Governing Bodies, and References.  No changes were made to the policy statement at this time.

Medical Policy Panel, April 2015

Medical Policy Group, April 2015 (6): Update to Description, Key Points, Key Words and References cooling devices; no change to policy statement.

Medical Policy Panel, October 2016

Medical Policy Group, October 2016 (6): Update to Description, Key Points, Governing Bodies, Key Words and References. No change to policy statement.

Medical Policy Group, January 2017 (6): Removed literature regarding Game Ready® device moved to medical policy #123, Lymphedema Pumps; removed Game Ready® from Key Words.

Medical Policy Panel, October 2017

Medical Policy Group, October 2017 (6): Updates to Description, Policy statement, Key Points, Key words, Coding, Governing Bodies and References; added Game Ready device from medical policy #123.

Medical Policy Panel, March 2018

Medical Policy Group, March 2018 (6): Updates to Description and Key Points.

Medical Policy Panel, March 2019

Medical Policy Group, April 2019 (6):  Update to Description and Key Points; no changes to policy statement.

Medical Policy Panel, March 2020

Medical Policy Group, March 2020 (6): Updates to Key Points, Practice Guidelines, Governing Bodies, Key Words (Game Ready GRPro 2.1, Polar Care Wave) and References.

Medical Policy Group, December 2020 (6): Removed coding A4265, 97018.

Medical Policy Panel, March 2021

Medical Policy Group, March 2021 (6): Updates to Key Points. Clarified Policy statement to include "circulating" and "noncirculating".

Medical Policy Panel, March 2022

Medical Policy Group, March 2022 (6): Updates to Description, Key Points, Key Words, Governing Bodies and References.

Medical Policy Panel, March 2023

Medical Policy Group, April 2023 (6): Updates to Key Points, Governing Bodies, Benefit Application, Key Words and References.

Medical Policy Group, September 2023 (6) Updates to Current Coding to include A9273.

Medical Policy Panel, March 2024

Medical Policy Group, March 2024 (6): Updates to Key Points; Practice Guidelines and Position Statements, Key Words, Approved by Governing Bodies, and References. No change to Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.