Infrared Therapy (Clinical Policy Bulletin)
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This Aetna Clinical Policy Bulletin governs medical necessity and investigational determinations for infrared therapy modalities (including infrared coagulation and low-level infrared/MIRE/Anodyne systems) and indicates covered indications and those considered experimental/investigational for Aetna members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Infrared Therapies
Medical Necessity - Infrared coagulation
Covered when ALL of the following are met
See Appendix for hemorrhoid grading.
Evidence summaries by indication
Evidence summaries and coverage-relevant conclusions by indication
Safety similar between groups; mortality and SAE rates not significantly different.
CMS (2006) concluded infrared devices are not reasonable and necessary for peripheral sensory neuropathy, wounds and ulcers, and related conditions.
Choice guided by hemorrhoid grade; IRC typically requires about 2 sessions.
Protocols and durability of effect not established.
Not recommended for routine use at this time.
Patient preferences should guide preventive treatment decisions given limited evidence.
Heterogeneity in PBM parameters and study quality limits conclusions; more robust RCTs needed.
Potential risks and heterogeneity of devices/parameters warrant further study.
Evidence-based summary (no explicit coverage rules in this segment)
No explicit coverage decision stated in this extract.
Evidence summaries by indication
Summary of clinical evidence for PBM/IRC by indication:
More robust RCTs with standardized dosimetry and exercise prescriptions needed.
Studies limited by lesion selection, follow-up, and generalizability.
Standardized intervention protocols needed.
Evidence primarily from animal models.
Preliminary and heterogenous clinical data.
Device FDA-cleared for hemorrhoids; choice vs RBL guided by grade and symptomatology.
The policy lists the infrared glove (e.g., Prolotex Therapy Glove) among interventions considered experimental/investigational. This designation reflects that evidence is insufficient to establish effectiveness of the glove for Raynaud's syndrome or any other indications; therefore use of the glove for these conditions is categorized as investigational and not supported as medically necessary under this CPB.
A 2006 CMS decision memorandum concluded that the use of infrared devices is not reasonable and necessary for treatment of diabetic and non-diabetic peripheral sensory neuropathy, wounds and ulcers, and related conditions. In practice, this means claims for infrared modalities billed for peripheral neuropathy or similar wound indications are at risk for noncoverage and should be considered unsupported by the available Medicare-level determination.
Major clinical syntheses in UpToDate do not list infrared therapies as options for migraine management. The absence of infrared in authoritative reviews of acute and preventive migraine care implies that infrared modalities are not established or standard therapies for chronic migraine and should be considered unsupported by current clinical guidance.
Infrared coagulation (IRC) devices are FDA-cleared for treatment of hemorrhoids and anal warts, but are not FDA-approved specifically for anal squamous intraepithelial lesions (SIL). This regulatory status is noted as relevant when assessing coverage because available IRC studies for anal HSIL are promising but the device’s label does not explicitly include anal SIL.
Randomized, double-blind trials of low-level infrared therapy (Anodyne MIRE) for diabetic peripheral neuropathy have not shown benefit over sham. For example, a 90-day home-use randomized trial (Lavery et al., 2008) found no significant differences between active and sham groups on measures of sensation, nerve conduction, pain, or quality of life. In addition, the CMS determination (2006) concluded infrared devices are not reasonable and necessary for peripheral sensory neuropathy, supporting the view that MIRE lacks demonstrated clinical benefit for diabetic neuropathy.
Monochromatic infrared energy (MIRE) and similar low-level infrared devices have not demonstrated superiority to sham control in randomized trials. Several double-blind, sham-controlled studies (including Lavery et al. 2008 and Franzen‑Korzendorfer et al. 2008) reported no significant differences between active and sham treatment for sensation, transcutaneous oxygen, pain, or related outcomes, indicating lack of consistent efficacy versus placebo.
For indications supported only by small, low-quality trials or heterogeneous early studies (for example, preventive light therapy for seasonal affective disorder and PBM for tendinopathy), the available evidence is insufficient to establish effectiveness. Systematic reviews identify high risk of bias, very small sample sizes, and imprecision in effect estimates, so these indications lack robust data to support coverage as medically necessary.
Coding and Billing Guidance
| 46930 | Destruction of internal hemorrhoid(s), by thermal energy (eg, infrared coagulation, cautery, radiofrequency). |
| 97026 | Application of a modality to one or more areas; infrared. |
| K62.82 | Dysplasia of anus. |
| K64.0 | First degree hemorrhoids. |
| K64.1 | Second degree hemorrhoids. |
| B35.1 | Tinea unguium [onychomycosis]. |
| I73.00 | Raynaud's syndrome. |
| G43.001 | Migraine codes (example range referenced). |
| E08.00 | Diabetes mellitus (example range referenced). |
Provider Actions, Prior Authorization & Documentation
Prior Authorization / Code–Coverage Linking
Prior authorization may be required and coverage depends on matching billed codes to the policy indications. CPT 46930 (Destruction of internal hemorrhoid(s) by thermal energy, e.g., infrared coagulation) is covered when the selection criteria for anal dysplasia (biopsy-proven HSIL) or Grade I–II internal hemorrhoids are met. Low-level infrared therapy codes (e.g., 97026, Anodyne/MIRE descriptors, and related HCPCS such as E0221, A4639) are not covered for indications listed as investigational or non-covered in this policy.
CMS Noncoverage Finding (2006)
A 2006 CMS decision memorandum concluded there is sufficient evidence that infrared devices are not reasonable and necessary for treatment of diabetic and non‑diabetic peripheral sensory neuropathy, wounds and ulcers, and similar related conditions (including associated pain). Plans and prior‑authorization processes should reflect this CMS noncoverage finding when adjudicating claims for these indications.
- CMS (2006): infrared devices not reasonable/necessary for peripheral neuropathy, wounds, ulcers and similar conditions
Prior Authorization Recommended for Experimental IR / PBM Applications
Prior authorization is recommended for experimental or investigational applications of infrared radiation (IR) or photobiomodulation (PBM), such as transcranial pulsed PBM (tPBM) for traumatic brain injury or other neurologic indications, until larger controlled studies demonstrate safety and effectiveness.
- Experimental/Investigational examples: transcranial pulsed PBM (tPBMT) for TBI, Anodyne/MIRE for neuropathy, other off‑label PBM uses
Prior Authorization Considerations for IRC (Anal Dysplasia / HSIL)
For infrared coagulation (IRC) for anal HSIL, prior authorization/medical necessity review should expect documentation that supports the indication and procedure: biopsy‑proven anal HSIL (HGAIN/AIN II/III), high‑resolution anoscopy (HRA) findings, description of the index lesion(s), treatment plan, and scheduled follow‑up (e.g., HRA at regular intervals).
- Required documentation: biopsy-proven HSIL (index lesion[s])
- Procedural documentation: HRA findings, location/size/number of lesions, IRC treatment details
- Follow-up: planned surveillance and biopsy strategy (e.g., HRA and biopsies per guideline or study protocol)
Documentation for Covered Coagulation (Hemorrhoids / Anal Dysplasia)
When IRC is billed for coagulation of hemorrhoids using CPT 46930, retain documentation demonstrating the covered diagnosis (e.g., K62.82 for anal dysplasia or K64.0–K64.1 for 1st–2nd degree hemorrhoids), treatment rationale, and that alternative, established non-surgical therapies were considered where appropriate (for hemorrhoids — e.g., rubber band ligation).
- Diagnostic ICD-10s supporting coverage: K62.82 (dysplasia of anus); K64.0–K64.1 (first and second degree hemorrhoids)
- Sequencing note: consider/summarize prior non-surgical treatments (rubber band ligation, topical measures) when applicable
Recommended Outcome Measures to Document
Trials and studies vary in reported outcome measures; when submitting clinical evidence or prior‑authorization materials, include relevant objective outcome measures where available: vibration perception thresholds (VPT), Semmes‑Weinstein monofilament testing, nerve conduction studies, standardized neurologic/functional scales (e.g., NIHSS, mRS) or lesion‑clearance endpoints for IRC (complete index HSIL clearance at specified follow‑up).
- Peripheral neuropathy outcomes: VPT, SWM (monofilaments), nerve conduction studies
- Stroke/TBI/neurologic studies: NIHSS, mRS, functional scales, SPECT measures (when applicable)
- IRC for HSIL: index lesion clearance at defined time points (e.g., 12 months)
Device and Measurement Documentation
Device and measurement details affect interpretation of results and are expected in records supporting medical necessity. Document device make/model, settings (power, wavelength, pulse parameters), treatment duration, distance/spot size, and test conditions (e.g., instrument model for thermometry, tester identity) that could influence outcome measures.
- Record device specifics: manufacturer/model, wavelength, power density, pulse frequency, duration/number of treatments
- Measurement context: instrument model, distance-to-spot, emissivity, tester ID for temperature/neurologic measures
Studies Report Requirement for Biopsy-Proven HSIL and Structured Follow-up
Studies of IRC for anal HSIL typically require biopsy‑proven HSIL for enrollment and report structured follow‑up with HRA and biopsy to document index lesion clearance or recurrence. Prior‑authorization and medical records should mirror these evidentiary expectations when asserting medical necessity for IRC.
- Evidence expectation: biopsy-proven HSIL (index lesion[s]) prior to IRC
- Follow-up evidence: HRA and biopsies per protocol to demonstrate clearance or recurrence
Retain Documentation per Aetna Clinical Policy Bulletin Guidance
Providers should retain complete clinical documentation to support medical necessity determinations in accordance with Aetna Clinical Policy Bulletin guidance. The CPB provides the policy framework; however, plan‑specific provisions (benefits, prior‑authorization processes, and coverage exceptions) govern payment decisions.
- Retain all records supporting indication, procedure, device details, outcomes, and prior treatments
- Note: CPB guides benefit administration but payer plan provisions ultimately determine coverage
Consider Established Alternatives and Note Guideline Variability
When IR is considered for prevention or non‑treatment indications (e.g., prevention of seasonal affective disorder or neuropathy), prefer established preventive or therapeutic alternatives with stronger evidence. Guideline recommendations vary and multiple treatment modalities exist for conditions such as SAD and anal HSIL; document rationale when selecting IR over other options.
- Clinical preference: use established preventive/therapeutic options before experimental IR uses
- Guideline variability: note that recommendations differ across societies for anal HSIL management; provide justification when deviating
Background and Evidence Context
Low-level infrared therapy (MIRE) delivers single-wavelength infrared energy via flexible pads containing multiple infrared-emitting diodes (commonly 60 diodes per pad). The modality is proposed to increase nitric oxide release from hemoglobin, with the intended downstream effects of vasodilation, reduced swelling and improved microcirculation; the Anodyne Therapy System is an example of such a device.
Key points about MIRE / low-level infrared therapy: it is a low-energy infrared modality delivered by diode-containing pads applied to the skin, often promoted for wound healing and peripheral neuropathy. The mechanisms cited include purported nitric-oxide–mediated increases in circulation. Meta-analyses and randomized trials have not demonstrated consistent benefit for chronic non-healing wounds or neuropathy, and overall evidence is limited.
Key Definitions and Hemorrhoid Grading
Revision History
Policy last reviewed on 09/08/2023.
Policy effective date established as 03/19/2002.
Next scheduled policy review set for 06/27/2024.
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