Cold Therapy Devices/ Heating Devices/ Combined Heat and Cold Therapy Devices Form

Description

Cold therapy devices combine cold temperatures and compression to decrease discomfort and swelling following injury or surgery to an extremity. The theory behind cold therapy is that by decreasing the temperature of the tissue, which produces vasoconstriction, pain is lessened, muscle spasm is decreased and inflammation is reduced.

Active cold therapy devices and combined heat and cold therapy devices utilize pneumatic or mechanical pumps that may be battery or electric powered. The intended function of the pump is to provide cyclical compression and cooling or heating to the affected area. The devices generally consist of two basic parts: a wrap or wrap system and a control unit or pump, which is filled with ice and/or water.

Cold Therapy Devices/Heating Devices/Combined Heat and Cold Therapy Devices

Effective Date: 09/28/2023

Revision Date: 09/28/2023

Review Date: 09/28/2023

Policy Number: HUM-0385-019

The control unit or pump circulates the cooled or heated water through the wrap system to the affected area.

Passive cold therapy devices operate by gravity or a hand pump without the use of a battery or electricity. Generally, they consist of a cuff or wrap and a cooler. Ice water is placed in the reservoir (cooler). The cooler is placed above the affected body area or joint and then utilizes gravity to fill the cuff and compress the joint.

Heating devices are used for a variety of indications including joint pain and muscle spasms. The application of heat may ease pain by dilating the blood vessels and decreasing painful stiffness of soft tissues surrounding the injured area.

Examples of active cooling or heating devices and/or combination compression and cooling devices include, but may not be limited to:

• AirCast Cryo/Cuff IC Cooler System – Therapy system consisting of a cuff, a cooler and a hose. The hose exchanges cooled ice water between the cooler and the cuff which covers the injured area. Unlike the AirCast Cryo/Cuff Gravity Cooler, this system contains a built-in pneumatic pump, and provides cold and compression by either gravity or motorized electrical power.
• BioCryo Cold Compression System – A cold compression system that uses a cold gel pack insert, rather than ice and water. A pneumatic compression pump provides the intermittent compression.
• DonJoy IceMan Clear3 Cold Therapy System and DonJoy Iceman Classic3 Cold Therapy Unit – Utilize a semi-closed loop system with a mechanical pump that allows cooled water to circulate at a constant flow rate, providing consistent cold distribution throughout the pad.
• Game Ready GRPRO 2.1 – System that combines cold and intermittent pneumatic compression therapies. It includes a computer that controls treatment time, level of compression and temperature. The unit continuously cycles liquid through circumferential wraps for consistent, long lasting cold treatment, even over large surface areas.

rubber pads (blankets) that are connected by a hose to a main cooling unit (the JetStream Cold/Hot Therapy Unit). The pads receive fluid that has circulated from the main unit and can be either hot or cold.

The Deroyal CoolJet Cold Therapy Unit is similar to the JetStream; however, it only has the option for cold therapy.

• Polar Care Cube, Polar Care Glacier, and Polar Care Kodiak Cold Therapy Systems – Provide cold therapy via a battery powered pump to a reusable pad, which is applied to the area of the body to be treated. These devices differ on the length of continuous treatment they may provide.
• Polar Care Wave – Combines motorized cold therapy with intermittent active compression.
• ThermoComp Cold Therapy – Provides continuous cold therapy at preprogrammed intervals without the need to add water or ice; power provided by an electric motor. This device does not provide pneumatic compression.
• ThermoComp Compression Therapy, VascuTherm 4 and VPulse – Devices that combine cold therapy with intermittent compression.
• ThermoComp Contrast Therapy – Provides contrast therapy with 20 minutes of cold therapy followed by 10 minutes of heat therapy; power is supplied by an electrical pump.
• VascuTherm 5 – System that combines cold or heat with intermittent pneumatic compression therapy. It may also provide thermal contrast therapy consisting of 20 minutes of cold therapy followed by 10 minutes of heat therapy while also delivering intermittent pneumatic compression.
• VitalWrap System – This system consists of 3 components: a control unit, a tubing set and a thermal fabric wrap. The control unit, which includes a fluid reservoir, manages the temperature of water used by the system to supply heat or cold to the fabric wrap attached to the body. Compression is delivered through the wrap itself.

Examples of passive cold therapy devices include, but may not be limited to:

• AirCast Cryo/Cuff Gravity Cooler – Therapy system consisting of a cuff, a cooler and a hose. The hose exchanges cooled ice water between the cooler and the cuff which covers the injured area. Elevating the cooler fills and pressurizes the cuff. Compression is controlled by gravity and is proportional to the elevation of the cooler.
• Cryo Pneumatic Knee Splint and Cryo Pneumatic Shoulder – This device combines cold therapy with pneumatic compression. The cold therapy is provided by a removable/reusable gel pack, and the compression is controlled by a pump bulb that can be detached once the desired compression is achieved. Similar systems include the Cryo Pneumatic Knee Orthosis w/Hinge and Cryo Pneumatic Knee Orthosis w/ROM Hinge.
• Elasto-Gel Cold/Hot Therapy Wrap – Reusable gel packs, which may be cold or heated, are inserted into a wrap, which may be applied to the extremities, head, neck, low back or sinuses.
• Polar Care (PC) Cub Unit – Cold therapy system which includes a PC Cub cooler, manual pump and wrap on pads. The pads are held in place with elastic straps or an ACE wrap.

The built-in hand pump circulates the cold water through the polar pad, while at the same time increases the compression around the joint.

Examples of passive heating devices include, but may not be limited to:

• Heat Lamp – Lamp that emits infrared light and produces topical heat to the skin.
• Heating Pad – Pad that has an electric or infrared heating element and is used to apply topical heat to the skin.
• Paraffin Bath – A container that holds and heats a mixture of mineral oil and paraffin into which the individual may either continuously immerse the treated body part (such as the hand or foot) for 20-30 minutes or repetitively dip and remove the treated area from the paraffin.

Cold Therapy Devices/Heating Devices/Combined Heat and Cold Therapy Devices

Effective Date: 09/28/2023

Revision Date: 09/28/2023

Review Date: 09/28/2023

Policy Number: HUM-0385-019

Page: 5 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

The VibraCool Cryovibration system, promoted as a treatment for joint or muscle pain, plantar fasciitis or tendonitis, consists of a vibration unit with specially designed ice packs, secured via an adjustable neoprene strap. The high-frequency vibration is purported to massage muscles and improve blood flow while the ice decreases pain, swelling and inflammation.

Scalp hypothermia, via a cooling cap, has been proposed for preventing alopecia (hair loss) for an individual undergoing chemotherapy. This may be accomplished via passive (manual) caps that require chilling/freezing, or via automatic machine-based cooling systems. Examples of cooling caps include, but may not be limited to, the Arctic Cold Cap, Chemo Cold Cap, Penguin Cold Cap Therapy System, Warrior Caps and Wishcap Cold Cap. Examples of machine-based cooling systems include, but may not be limited to, the DigniCap Cooling System and Paxman Scalp Cooling System.

The Ebb CoolDrift Versa (formerly Cereve Sleep System) was granted US Food & Drug Administration (FDA) approval as a purported method for the treatment of insomnia. The system is a cooling device comprised of 3 components: the bedside unit, the forehead pad, and headgear. The device pumps chilled fluid through the forehead pad, at individually selectable temperatures.

The Cooral Oral Cooling System was granted De Novo clearance by the FDA and is proposed for use in an individual with cancer who is undergoing chemotherapy to prevent oral mucositis. It consists of a single-use mouthpiece connected to a portable cryotherapy system that circulates sterile cold water through the oral device.

For information regarding the use of hot or cold packs, diathermy, infrared heat or paraffin baths as a physical therapy modality, please refer to Physical Therapy and Occupational Therapy Medical Coverage Policy.

Coverage Determination

Humana members may NOT be eligible under the Plan for any devices providing the following types of therapy:

• Active cold therapy devices; OR
• Combination cold and heat therapy devices; OR

Cold Therapy Devices/Heating Devices/Combined Heat and Cold Therapy Devices

Effective Date: 09/28/2023

Revision Date: 09/28/2023

Review Date: 09/28/2023

Policy Number: HUM-0385-019

Page: 6 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Combination cold therapy and compression devices; OR
• Heat therapy devices; OR
• Passive cold therapy devices; OR
• Passive heating devices; OR
• VibraCool Cryovibration system

Therapy administered with these devices has not been proven to be any more efficacious than traditional delivery of cold/heat (e.g., ice packs, heating pads) and therefore these devices are considered convenience items. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for Cooral Oral Cooling System for any indication, including prevention of oral mucositis in an individual with cancer who is undergoing chemotherapy. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for the Ebb CoolDrift Versa for the treatment of insomnia. Although they may be prescribed by a health care practitioner, the Ebb CoolDrift Versa is also available without a prescription and may be obtained over-the-counter (OTC) and is therefore generally excluded in the certificate. In the absence of a certificate exclusion for OTC items, the Ebb CoolDrift Versa is considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for scalp hypothermia/cooling caps (mechanical powered or manual [passive]) for preventing hair loss associated with chemotherapy treatment. This is considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Note: The criteria for heat therapy devices and scalp hypothermia are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Cold Therapy Devices/Heating Devices/Combined Heat and Cold Therapy Devices

Effective Date: 09/28/2023

Revision Date: 09/28/2023

Review Date: 09/28/2023

Policy Number: HUM-0385-019

Page: 7 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Background

Additional information about sprains, strains and other musculoskeletal injuries may be found from the following websites:

• American Academy of Orthopaedic Surgeons
• National Institute of Arthritis and Musculoskeletal and Skin Diseases
• National Library of Medicine

Additional information about hair loss associated with chemotherapy may be found from the following websites:

• American Cancer Society
• National Library of Medicine

Additional information about insomnia may be found from the following websites:

• National Center on Sleep Disorders Research
• National Library of Medicine

Medical Alternatives

Alternatives to cold therapy devices/heating devices/combined heat and cold therapy devices include, but may not be limited to, the following:

• Compression (e.g., ACE wrap)
• Elevation
• Heating packs
• Ice packs
• Prescription drug therapy
• Rest

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Cold Therapy Devices/Heating Devices/Combined Heat and Cold Therapy Devices

Effective Date: 09/28/2023

Revision Date: 09/28/2023

Review Date: 09/28/2023

Policy Number: HUM-0385-019

Page: 8 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled.

Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.