Heating Devices

Number: 0540

Policy

1. Aetna considers electric heating pads medically necessary durable medical equipment (DME) to relieve certain types of pain, decrease joint and soft tissue stiffness, relax muscles, or reduce inflammation.  A heating pad is not of proven value to treat pain due to peripheral neuropathy, including but not limited to diabetic neuropathy.

2. Aetna considers passive hot plus cold therapy medically necessary for indications outlined in CPB 0297 - Cryoanalgesia and Therapeutic Cold.

3. Aetna considers heat lamps unproven because the safety of heating lamps in the home setting has not been established. 

4. Aetna considers portable paraffin baths medically necessary DME for members who have undergone a successful trial period of paraffin therapy and the member's condition (e.g., severe rheumatoid arthritis of the hands) is expected to be relieved by the long-term use of this modality.  Standard (non-portable) paraffin baths are not considered appropriate for home use.

5. Aetna considers mechanical heated water-circulating pads and pumps experimental and investigational because they have not been proven to produce outcomes superior to standard electric heating pads.

6. Aetna considers infrared heating pad systems experimental and investigational because they have not been proven to have a therapeutic effect on any conditions for which they were developed.  See also CPB 0604 - Infrared Therapy.

7. Aetna considers the PainShield MD low-frequency ultrasonic diathermy device for home use experimental and investigational because its effectiveness has not been established.
   

8. Aetna does not cover any of the following heating devices because they are institutional equipment that is not appropriate for home use:

   1. Hydrocollator units (hot packs); or
   2. Microwave diathermy devices; or
   3. Short-wave diathermy devices; or
   4. Ultrasound devices; or

   These modalities must always be performed by or under the supervision of a qualified physical therapist. 

9. The following heating devices do not meet Aetna's contractual definition of DME because they are not primarily medical in nature and are normally of use in the absence of illness or injury:

   1. Heat and massage foam cushion pads; or
   2. Hot water bottles; or
   3. Portable room heaters.

Note: Usually, no more than 1 heating device is considered medically necessary for each medical condition.  Requests for multiple heating devices are subject to medical review.

Background

Heating devices (fomentation devices) are used for a variety of indications including joint pain and muscle spasms. Application of heat results in the production of hyperemia, induction of reflex vasodilation, and acceleration of metabolic processes. The application of heat may ease pain by dilating the blood vessels and decreasing painful stiffness of soft tissues surrounding the injured area. General indications for therapeutic heat include pain, muscle spasm, contracture, tension myalgia, hematoma resolution, bursitis, tenosynovitis, fibrositis, fibromyalgia, superficial thrombophlebitis, and collagen vascular diseases.  General contraindications and precautions for therapeutic heat include acute inflammation, trauma, or hemorrhage; bleeding disorders; temperature insensitivity; inability to communicate or respond to pain; poor thermal regulation (e.g., from neuroleptics); malignancy; edema; ischemia; atrophic skin; and scar tissue.

Hot Packs

Hot packs, also known as hydrocollator packs, warm tissue by conduction.  They typically consist of canvas bags filled with silicon dioxide that absorbs many times its own weight in water.  Hot packs are immersed in a hot water bath, and are removed from the bath when needed, wrapped in 6 to 8 layers of toweling or an insulating cover, and applied to the patient.  They are used to heat the body part prior to physical therapy.  To avoid scalding, excess water should be drained from the pack and the covering towels or pad should be checked for excessive dampness.  The packs cool slowly and can remain warm for 30 or more mins.  Medicare considers hydrocollator units as non-covered institutional equipment.

Heating Pads

A heating pad is a pad that has an electric or infrared heating element and is used to apply topical heat to the skin.

A standard electric heating pad is a flexible device containing electric resistive elements producing heat. It must have a fabric cover. It must have a timing device for automatic shut-off. It may include heat-retaining material (e.g., gel, fluid, vegetable matter). If so, the heat retaining materials must be contained in an enclosed pouch or bag in or around the heating elements. The heating pad must be certified by Underwriters Laboratories. A heating pad that includes a cover or other element that utilizes water vapor (humidity) drawn from the air to create moisture when heated is billed using this code.

A moist electric heating pad is a flexible device containing electric resistive elements producing heat. It must have a fabric cover. It must have a timing device for automatic shut-off. It must have a component that absorbs and retains liquid water. The water containing element must be protected from contact with the electrical components and the water must be in direct contact with the skin on application. The heating pad must be certified by Underwriters Laboratories. A cover or other element that utilizes water vapor (humidity) drawn from the air to create moisture when heated does not meet the definition of this code. Water must be added to the device to meet the description of this code.

Because electric heating pads do not cool spontaneously, use should be limited to 20 mins to avoid the risk of burns.  There is no evidence that the use of circulating-water heating pads or moist electric heating pads provide superior outcomes, in terms of enhancing recovery of function, compared to standard electric heating pads.  According to Medicare DME MAC policy, it has not been established that a moist electric heating pad is reasonable and necessary compared to a standard electric heating pad.

According to Durable Medical Equipment Medicare Administrative Contractor (DME MAC) policy, standard electric heating pads are necessary to relieve certain types of pain, decrease joint and soft tissue stiffness, relax muscles, or reduce inflammation.  DME MAC policy states that a heating pad is not reasonable and necessary to treat pain due to peripheral neuropathy, including but not limited to diabetic neuropathy.

In uncomplicated cases, heat treatments of this type, as well as paraffin baths, may not require the skills of a physical therapist.

Water Circulating Heating Pad with Pump

A water circulating heat pad with pump is a flexible pad containing a series of channels through which water is circulated by means of an electrical pumping mechanism. The water is heated in an external reservoir. The pump, pad, and all accessories needed for the pad to be functional are included in the code. The device must be certified by Underwriters Laboratory.

A pad for water circulating heat unit, for replacement only is a durable replacement pad used with a water circulating heat pump system. It is made of rubber, heavy plastic, or durable fabric. It can be cleaned and is designed for long term use.

According to Medicare DME MAC policy, it has not been established that a water circulating heat pad with pump is reasonable and necessary compared to a standard electric heating pad.  The policy states that, because a water-circulating heating pad system is not medically necessary, a replacement pump or pad is not reasonable and necessary.

Heat Lamps

A heat lamp is a lamp that emits infrared light and produces topical heat to the skin. Heat lamps warm tissues by conversion (i.e., by converting radiant energy to heat).  Heat lamps often use 250-Watt incandescent bulbs and are usually placed about 40 to 50 cm from the patient.  Because ordinary incandescent light bulbs produce large amounts of infrared energy, special infrared sources (e.g., quartz, tungsten) are seldom necessary.  Heating rates and maximum temperatures are controlled by adjusting the distance between the lamp and the patient.  Heat lamps may be preferred over hot packs where the patient is difficult to position or can not tolerate pressure.  Heat lamps may also be easier to use than hot packs.  According to DME MAC policy, the safety and effectivness of using a heat lamp in the home setting is not established.

Paraffin Baths

A paraffin bath is 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.

Paraffin baths are primarily used to treat contractures, particularly for patients with rheumatoid arthritis, hand contractures, or scleroderma.  The typical paraffin bath consists of a container filled with approximately a 1:7 mixture of mineral oil and paraffin maintained at 52^°C to 54^°C.  Although paraffin-oil mixtures can be heated in a double boiler or stove, small commercial units are available for home use, which have the advantages of ease of use and increased safety. The patient may either continuously immerse the treated part for 20 to 30 minutes, or may repetitively dip and remove the treated area from the paraffin.

Ultrasound

Ultrasound is sound above the limits of human hearing.  The therapeutic effects of ultrasound result from the conversion of sound to heat energy.  Ultrasound diathermy typically employs frequencies between 0.8 and 1 MHz.

Ultrasound diathermy is considered a deep heating modality in that most absorption occurs far beneath the skin.  It is most commonly used to treat tendonitis and bursitis, musculoskeletal pain, degenerative arthritis, and contractures.  Maximal heating may be limited by deep tissue factors and not by skin tolerance.  Ultrasound may be applied directly by placing the applicator on the skin, or indirectly by immersing the body part and applicator in a water-filled container.

Because of the importance of appropriate technique and inherent dangers, ultrasound diathermy should be applied by a trained attendant and the devices are not appropriate for unsupervised home use.

Short-Wave Diathermy

Short-wave diathermy uses radio waves to heat tissue conversively; tissue is heated by the actions of a rapidly alternating electrical field.  Because of the inherent risks involved in application of this deep heating modality, short-wave diathermy machines are inappropriate for unsupervised use at home.

Microwave Diathermy

Microwave diathermy involves the use of microwaves for heating tissues, and offers an advantage over short-wave diathermy in treating small areas in that they can be relatively easily focused.  However, microwaves generally do not penetrate tissue as deeply as short-waves.

Microwave diathermy has been used primarily to heat relatively superficial muscles and joints.  Microwave diathermy is used relatively rarely, and indications for which microwaves would be appropriate often are treated with superficial heat, short-wave diathermy, or ultrasound.  Because of the importance of appropriate application technique and the inherent risks of this deep heating modality, microwave diathermy machines are inappropriate for unsupervised home use.

Infrared Heating Pads

An infrared heating pad system consists of a pad or pads containing mechanisms (for example, luminous gallium aluminum arsinide diodes) that generate infrared (or near infrared) light and a power source.  According to DME MAC policy, there are no indications for which these devices have been demonstrated to have any therapeutic effect.  DME MAC policy considers these devices and any related accessories not medically reasonable and necessary.  As a heating device, infrared heating pads have not been shown to be more effective than electric heating pads and hot packs, despite their greater cost. 

PainShield MD Low-Frequency Ultrasonic Diathermy Device for Home Use

The PainShield MD is an ultrasound (US) device used to apply heat to the tissues in the body with a transducer/applicator that is incorporated into a patch that adheres to the skin, as does a bandage.  It is used to generate continuous surface acoustic waves US at 90 KHz, through a reusable applicator/transducer that covers an area of about 6 cm2.  The small applicator allows treatment of less accessible body parts such as the heel and wrist.  The device include a transducer/applicator, rechargeable battery powered driver unit and a cable that connects the driver to the transducer.  The PainShield MD is indicated for the treatment of selected medical conditions such as pain relief, muscle spasm and joint contractures.

Rosenblum and colleagues (2014) noted that transcutaneous oxygen pressure (TcPO2) less than 30 mm Hg at the toe leads to local tissue hypoxia and non-healing wounds.  Studies regularly illustrated that TcPO2 values are strong predictors of healing and can accurately demonstrate altered levels when extremities have restricted blood flow.  These researchers examined the effectiveness of surface acoustic wave (SAW) in ischemic feet on local tissue oxygenation.  A total of 10 patients, ranging from 40 to 75 years of age and suffering from critical limb ischemia (CLI) were selected from a vascular surgery clinic to undergo evaluation with a PainShield SAW Patch device (NanoVibronix Inc, Melville, NY).  Patients were treated once with 96 KHz of SAW for 30 mins.  All patients had an ankle brachial index (ABI) of less than 0.4 mm Hg.  Two patients (patients 1 and 8) had necrosis of at least 2 toes on the affected limb and were given the device for nightly use for 1 month.  Through usage of SAW there was a significant increase in all patients' saturation values.  The recorded baseline in both patients with necrotic toes almost doubled and during usage there was still a measurable increase in oxygen saturation.  In both of these patients the subjective pain measures dropped significantly.  Pain, as assessed by the visual analog scale (VAS), dropped from 9 to 2 for patient 1 and from 8 to 3 for patient 8.  Patient 1 went from 5 methadone treatments per day to only 1 per day starting in week 3.  Patient 8 did not change their pain medication regimen.  The authors concluded that surface acoustic waves as delivered in this study had a positive effect on tissue oxygenation and saturation in ischemic feet.  In lower extremities that were not surgical candidates or were either in the pre- or post-surgical environment, an SAW patch device was a good therapy in elevating the extremities' O2 saturation.

Appendix

General indications for therapeutic heat include pain, muscle spasm, contracture, tension myalgia, hematoma resolution, bursitis, tenosynovitis, fibrositis, fibromyalgia, superficial thrombophlebitis, and collagen vascular diseases.

General contraindications and precautions for therapeutic heat include acute inflammation, trauma, or hemorrhage; bleeding disorders; temperature insensitivity; inability to communicate or respond to pain; poor thermal regulation (e.g., from neuroleptics); malignancy; edema; ischemia; atrophic skin; and scar tissue.

Table: CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":
Other CPT codes related to the CPB:
97010	Application of a modality to one or more areas; hot or cold packs
97018	paraffin bath
97024	diathermy (eg, microwave)
97026	infrared
97035	ultrasound, each 15 minutes
HCPCS codes covered if selection criteria are met:
A4265	Paraffin, per lb.
E0210	Electric heat pad, standard
E0215	Electric heat pad, moist
E0235	Paraffin bath unit, portable
HCPCS codes not covered for indications listed in the CPB:
A9273	Hot water bottle, ice cap or collar, heat and/or cold wrap, any type
E0200	Heat lamp, without stand (table model), includes bulb, or infrared element
E0205	Heat lamp, with stand, includes bulb, or infrared element
E0217	Water circulating heat pad with pump
E0218	Water circulating cold pad with pump
E0221	Infrared heating pad system
E0225	Hydrocollator unit, includes pads
E0236	Pump for water circulating pad
E0239	Hydrocollator unit, portable
E0249	Pad for water circulating heat unit; for replacement only
K1004	Low frequency ultrasonic diathermy treatment device for home use, includes all components and accessories [PainShield MD]
ICD-10 codes covered if selection criteria are met (too many to list):
ICD-10 codes not covered for indications listed in the CPB:
E08.40 - E08.49 E08.610, E09.40 - E09.49 E09.610, E10.40 - E10.49 E10.610, E11.40 - E11.49 E11.610, E13.40 - E13.49 E13.610	Diabetes with neurological manifestations
G90.01 - G90.9	Disorders of autonomic nervous system
G99.0	Autonomic neuropathy in diseases classified elsewhere

The above policy is based on the following references: