CurrentAetnaPolicy 0540

Heating Devices

Coverage and medical necessity criteria for home-use heating devices (electric heating pads, paraffin baths, water-circulating pads, heat lamps, infrared systems, and related equipment) for Aetna members.

Policy Summary

PayerAetna

PolicyHeating Devices

Policy CodePolicy 0540

Change TypeNo material change

Effective DateJul 3, 2001

Next Review DateJun 13, 2024

Key ActionDocument medical necessity and prior conservative therapy when requesting advanced heating devices or multiple devices; prior authorization may be required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1heating device per medical condition generally allowed

E0210/E0235example covered HCPCS

E0200, E0217...not covered examples

PainShield MDinvestigational device

11/10/2023last review

Coverage and Medical Necessity Criteria

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Medically necessary items

Covered when ALL of the following are met:

Standard electric heating pad: Aetna considers electric heating pads medically necessary DME to relieve certain types of pain, decrease joint and soft tissue stiffness, relax muscles, or reduce inflammation.Limit use to ~20 minutes to reduce burn risk.

Not of proven value for pain due to peripheral neuropathy (including diabetic neuropathy).

Passive hot plus cold therapy is considered medically necessary when used for indications outlined in CPB 0297 - Cryoanalgesia and Therapeutic Cold.

See related policy CPB 0297.

Portable paraffin bath (home-use): Portable paraffin baths are considered medically necessary for members who have undergone a successful trial period of paraffin therapy and whose condition (e.g., severe rheumatoid arthritis of the hands) is expected to be relieved by long-term home use.Typical paraffin immersion 20–30 minutes per session as described for home-use units.

Standard (non-portable) paraffin baths are not appropriate for home use.

Not medically necessary / investigational

The following devices and uses are considered not medically necessary or investigational:

Heat lamps are considered unproven/experimental because safety in the home setting has not been established.

Water-circulating heating pads and pumps: Mechanical heated water-circulating pads and pumps are considered experimental and investigational; not shown to be superior to standard electric heating pads.

Includes replacement pumps and replacement pads for these systems which are not reasonable and necessary.

Infrared heating pad systems are considered experimental and investigational and not medically reasonable and necessary per DME MAC policy; not shown to have demonstrated therapeutic effect compared to electric heating pads or hot packs.

See CPB 0604 - Infrared Therapy.

PainShield MD (low-frequency ultrasonic diathermy) for home use: The PainShield MD SAW/low-frequency ultrasonic diathermy device for home use is considered experimental and investigational because effectiveness has not been established.

Device-specific coverage stance

Coverage stance differs by device type and available evidence:

Infrared heating pads and related accessories are considered not medically reasonable and necessary; DME MAC finds no demonstrated therapeutic indications and they have not been shown to be more effective than electric heating pads or hot packs.

Reference: DME MAC policy.

Surface acoustic wave (SAW) devices (e.g., PainShield MD): Evidence is limited (small studies) showing potential improvements in tissue oxygenation and pain in ischemic feet; the policy does not establish routine coverage—clinical justification and objective baseline measures (e.g., TcPO2, ABI) should support any requested use.

Rosenblum et al. 2014: small study (n=10) showed increases in tissue oxygenation and reduced pain in selected CLI patients.

Excluded or non-covered heating devices and institutional modalities include: hydrocollator units (hot packs), microwave diathermy devices, short-wave diathermy devices, and ultrasound devices — these modalities must be performed by or under supervision of a qualified physical therapist and are not appropriate for unsupervised home use. Also not considered DME because they are not primarily medical in nature are heat and massage foam cushion pads, hot water bottles, and portable room heaters.

Additional non-covered or non‑reasonable items listed in coding and device tables include heat lamps (with or without stand), water‑circulating pad systems and their pumps or replacement pads, and devices or supplies identified as investigational (for example, the PainShield MD low‑frequency ultrasonic diathermy device and related supplies). Standard electric heating pads are the established home DME option; moist electric pads and circulating‑water systems have not been shown to provide superior outcomes compared to standard pads.

Per DME MAC policy and the CPB, infrared heating pads and any related accessories are considered not medically reasonable and necessary for home use; there are no indications for which these devices have been demonstrated to provide therapeutic effect.

Water‑circulating heating pad systems and moist electric heating pads are not established as reasonable and necessary compared with standard electric heating pads. Medicare DME MAC policy states that circulating‑water systems have not been shown to be superior, and because the system is not medically necessary, replacement pumps or pads are also not considered reasonable and necessary.

The DME MAC position is explicit: infrared heating pad systems and related accessories are not medically reasonable and necessary. The policy further notes that infrared pads have not been shown to be more effective than standard electric heating pads or hot packs despite being more costly; therefore claims for these devices are subject to denial.

Coding — HCPCS / CPT / ICD-10 References

HCPCS / CPT codes referencedmixed

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
A4265	Paraffin, per lb.
E0210	Electric heat pad, standard
E0215	Electric heat pad, moist
E0235	Paraffin bath unit, portable
A9273	Hot water bottle, ice cap or collar, heat and/or cold wrap, any type

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Covered HCPCS codes (when selection criteria are met)mixedCovered

A4265	Paraffin, per lb.
E0210	Electric heat pad, standard
E0215	Electric heat pad, moist
E0235	Paraffin bath unit, portable

HCPCS / CPT codes not covered for indications listed in the CPBmixedNot Covered

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

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Other CPT codes (related)CPT

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

ICD-10 codes referenced (not exhaustive)ICD-10

E08.40-E08.49	Diabetes with neurological manifestations (examples listed)
E08.610	Diabetes with neurological manifestations (example subgroup)
E09.40-E09.49	Diabetes with neurological manifestations (examples listed)
E09.610	Diabetes with neurological manifestations (example subgroup)
E10.40-E10.49	Diabetes with neurological manifestations (examples listed)
E10.610	Diabetes with neurological manifestations (example subgroup)
E11.40-E11.49	Diabetes with neurological manifestations (examples listed)
E11.610	Diabetes with neurological manifestations (example subgroup)
E13.40-E13.49	Diabetes with neurological manifestations (examples listed)
E13.610	Diabetes with neurological manifestations (example subgroup)

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Recommended continuous use time — safety limit

Recommended continuous use timeLimit continuous use of electric heating pads to 20 minutes to avoid risk of burns.

RationaleElectric heating pads do not cool spontaneously; limiting use reduces burn risk.

ApplicabilityApplies to standard electric heating pads; advised as general safety guidance for home use.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization / Medical Review Required

Prior authorization/medical review is required for covered heating devices when requests exceed standard limits or multiple devices are requested for the same condition. Document the clinical indication, prior conservative therapies tried (e.g., rest, NSAIDs, physical therapy, topical analgesics), the specific device requested, and why a standard electric heating pad is insufficient or contraindicated. Requests for experimental/investigational devices (infrared heating pad systems, water-circulating pads with pump, heat lamps, PainShield MD low-frequency ultrasonic diathermy) will be denied as not medically necessary per policy and DME MAC guidance.

Prior authorization required when requesting >1 heating device for the same condition.
Include documentation of prior conservative therapies and duration.
If requesting advanced/alternative devices, justify contraindication or failure of standard electric heating pad.

Denial Risk

Denial Triggers — Watch for These

Denials commonly occur for devices that the policy or DME MAC considers not reasonable and necessary (infrared heating pad systems, water-circulating heating pads with pump, heat lamps, hydrocollator units, PainShield MD and related accessories). Typical denial triggers include: no documentation of prior conservative therapy trial, requests for multiple devices without justification, billing codes for non-covered device types, or lack of objective clinical rationale for SAW/ultrasound patch use.

Common not-covered HCPCS/Codes that trigger denials: E0217, E0221, E0200, E0205, E0236, E0218, E0239, E0249, K1004.
Requests for multiple devices without medical justification.
Use of experimental/investigational codes or devices (see policy exclusions).

Documentation Required

Documentation Requirements and Provider Guidance

Providers must document prior conservative therapies (type, duration, and outcome) or specific contraindications when requesting devices beyond a standard electric heating pad. For requests involving SAW/ultrasound patches (e.g., PainShield studies), include objective measures when available (ABI, TcPO2, wound status) and clear clinical rationale; absence of objective data or failure to document trials of standard therapy increases likelihood of denial.

Document prior conservative measures (rest, NSAIDs, PT, topical therapy) and dates.
For SAW/ultrasound patch requests, provide objective measures such as ABI or TcPO2 and wound assessment.
State why standard electric heating pad use is unsuitable or has failed.

Device Definitions

Standard electric heating pad — definition and features

DefinitionA standard electric heating pad is a flexible device containing electric resistive elements producing heat with a fabric cover, an automatic shut-off timing device, and may include enclosed heat‑retaining material; must be UL certified.

Required featuresFabric cover and timing device for automatic shut‑off; heat‑retaining materials (if present) must be enclosed and not in direct contact with electrical elements.

Billing noteHeating pads that create moisture from ambient humidity do not meet the standard electric heating pad definition for moist pad codes.

Moist electric heating pad — definition and requirements

DefinitionA moist electric heating pad is a flexible device with electric resistive elements, a fabric cover, an automatic shut‑off timing device, and a component that absorbs and retains liquid water; the water must be added and be in direct contact with the skin on application; must be UL certified.

Moisture requirementA cover element that merely uses ambient humidity does NOT meet the moist pad definition; liquid water must be added to the device.

Electrical safetyThe water‑containing element must be protected from contact with electrical components to ensure safety.

Water‑circulating heat pad with pump — components

DefinitionA water‑circulating heat pad with pump is a flexible pad containing a series of channels through which water is circulated by an electrical pump; water is heated in an external reservoir; device must be UL certified.

Included componentsThe code includes the pump, the pad, and all accessories needed for the pad to be functional (reservoir, tubing, etc.).

Replacement padsA pad for a water‑circulating unit (replacement only) is a durable replacement made of rubber, heavy plastic, or durable fabric and designed for long‑term use and cleaning.

Infrared heating pad — definition and policy note

DefinitionAn infrared heating pad system consists of a pad or pads containing mechanisms (for example, luminous gallium aluminum arsenide diodes) that generate infrared or near‑infrared light and a power source.

Clinical stanceDME MAC policy states no demonstrated therapeutic indications; infrared systems have not been shown to be more effective than electric heating pads despite higher cost.

Coverage implicationInfrared heating pads and related accessories are considered not medically reasonable and necessary per DME MAC.

PainShield MD / SAW patch — device description and parameters

Device descriptionPainShield MD is a home‑use ultrasound device that applies continuous surface acoustic waves (~90 kHz) via a reusable transducer incorporated into an adhesive patch covering about 6 cm², with a rechargeable battery‑powered driver unit and connecting cable.

Indications describedDocument describes use for selected conditions such as pain relief, muscle spasm, and joint contractures.

Components includedIncludes transducer/applicator (adhesive patch), rechargeable driver unit, battery, and cable to connect driver to transducer.

Medical Necessity Rules and Device-Specific Requirements

DME medical necessity rules

Device-specific DME medical necessity rules and operational limits:

Standard electric heating pads — preferred: Standard electric heating pads are the established DME option and are considered medically necessary when selection criteria are met.Limit continuous application to approximately 20 minutes to reduce risk of burns.

Moist electric heating pads and circulating-water systems have not been shown to provide superior outcomes compared to standard electric heating pads.

Moist electric heating pads lack evidence of superiority over standard electric heating pads and are not established as medically necessary compared to standard pads.

Medicare DME MAC policy does not establish moist electric pads as reasonable and necessary compared to standard electric heating pads.

Water-circulating pad systems and components: Water-circulating heating pad systems with pump and their replacement components (pumps, pads) are not established as medically necessary compared to standard electric heating pads; replacement pumps or pads are not reasonable and necessary if the system is non-covered.

Paraffin bath (portable) — documentation requirement: Portable paraffin baths may be covered when the member has had a successful trial of paraffin therapy and long-term home use is expected to provide benefit (eg, severe rheumatoid arthritis of the hands).Typical paraffin use 20–30 minutes per session as described for home-use units.

Standard non-portable paraffin baths are not appropriate for home use; requests for multiple heating devices are subject to medical review.

SAW device (PainShield MD) medical necessity

For SAW devices (PainShield MD) the following documentation and justification are required to support medical necessity review:

Documented diagnosis: Provide a documented diagnosis appropriate for the device (for example, critical limb ischemia or another specified painful condition).

Objective baseline measures: Provide objective baseline measures such as transcutaneous oxygen pressure (TcPO2) and ankle–brachial index (ABI) to demonstrate ischemia or impaired tissue oxygenation.

Rosenblum et al. used TcPO2 and ABI; TcPO2 < 30 mm Hg at the toe is associated with tissue hypoxia.

Clinical rationale and expected benefit: Provide a clinical rationale that the SAW device is expected to improve tissue oxygenation or symptoms for the individual member, and reference available clinical evidence where applicable.

Evidence is limited (small studies); policy considers PainShield MD experimental/investigational.

Rental, Purchase, and Component Coverage Rules

Item	Coverage stance	Notes / rationale
Water-circulating heat pad with pump (E0217)	Not covered / Not reasonable and necessary	Medicare DME MAC policy: not established as reasonable and necessary compared to standard electric heating pads; includes pump and accessories; replacement pumps or pads also not reasonable and necessary.
Pad for water circulating heat unit — replacement only (E0249)	Not covered / Not reasonable and necessary	Replacement pads for non‑covered water‑circulating systems are also not reasonable and necessary per DME MAC policy.
Pump for water circulating pad (E0236)	Not covered / Not reasonable and necessary	Replacement or separate pumps for water‑circulating systems are not reasonable and necessary because the underlying system is not covered.

Feature	Standard electric heating pad (preferred) — E0210	Moist electric / Water-circulating systems — E0215, E0217, E0236, E0249
Definition	Flexible device with electric resistive elements, fabric cover, automatic shut‑off; UL certified.	Moist: similar to standard but contains water‑retaining component; Water‑circulating: flexible pad with channels circulating heated water from external reservoir via pump; UL certified.
Coverage preference	Considered medically necessary DME when selection criteria are met; preferred first‑line option.	Considered not established as reasonable and necessary compared to standard electric heating pads; water‑circulating systems and replacement components are not covered.
Evidence / rationale	Established DME option; used to relieve pain, decrease stiffness, relax muscles, reduce inflammation.	No evidence of superior outcomes over standard electric pads; Medicare DME MAC states moist and water‑circulating pads are not established as reasonable and necessary.
Usage safety guidance	Limit continuous use to ~20 minutes to avoid burn risk.	Same safety concerns apply; because not demonstrated superior, not covered for home use.
Billing implications / codes	Covered if selection criteria met: E0210 (electric heat pad, standard).	HCPCS not covered for indications listed: E0215 (moist electric pad), E0217 (water circulating pad with pump), E0236 (pump), E0249 (replacement pad).

Documentation Requirements for Medical Review

Documentation Required

Evidence of prior trial and clinical rationale for portable paraffin baths

For portable paraffin baths, include documentation of a prior successful trial of paraffin therapy and a clinical rationale that long‑term home use is expected to relieve the member's condition (for example, severe rheumatoid arthritis of the hands).

Describe the prior trial (duration, response) and anticipated benefit from home use.
Note that standard (non‑portable) paraffin baths are not appropriate for home use; coverage applies to portable units (E0235) after successful trial.

Documentation Required

Required objective measures and indication documentation

When documenting indications for higher-risk or investigational heating therapies, include objective measures and prior treatments: TcPO2 and ABI values, specific indication (e.g., ischemic foot, pain), prior conservative treatments, and expected clinical benefit.

Objective tests: transcutaneous oxygen pressure (TcPO2) and ankle‑brachial index (ABI) when relevant to ischemic conditions.
Document prior therapies tried (topical heat, medications, wound care) and the anticipated improvement from the requested device.

OpenPayer

Heating Devices

Coverage and Medical Necessity Criteria

Coding — HCPCS / CPT / ICD-10 References

Provider Actions, Prior Authorization, and Documentation

Background and Clinical Context

Device Definitions

Medical Necessity Rules and Device-Specific Requirements

Rental, Purchase, and Component Coverage Rules

Documentation Requirements for Medical Review

Items and Devices Not Covered