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CurrentAetnaPolicy 0363

Cold Laser and High-Power Laser Therapies

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This clinical policy bulletin governs coverage determinations for cold (low‑level) laser therapy and high‑power (class IV) laser therapies, including when LLLT is considered medically necessary (prevention of oral mucositis) and numerous indications deemed experimental/investigational. It applies to Aetna benefit plans and providers submitting claims for these therapies.

Policy Summary

PayerAetna

PolicyCold Laser and High-Power Laser Therapies

Policy CodePolicy 0363

Change TypeNo material change

Effective Date11/09/1999

Last ReviewFeb 15, 2024

Next Review Date04/11/2024

Key ActionVerify that selected CPT/HCPCS/ICD-10 codes meet the policy's selection criteria and submit indication-specific evidence when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Medically necessary indications

50Experimental/Investigational items

MultipleCodes referenced

600–1000 nm; 5–500 mWWavelength/power

Heterogeneous dosimetryCommon limitations noted

Coverage Criteria and Evidence Summary

Medical Necessity — Oral Mucositis Prevention

Covered when ALL of the following are met

Prevention of oral mucositis: Low-level laser therapy is considered medically necessary for prevention of oral mucositis in persons undergoing cancer treatment associated with increased risk of oral mucositis, including chemotherapy and/or radiotherapy, and/or hematopoietic stem cell transplantation.

Experimental and Investigational

Not covered (experimental/investigational) for the following indications

Experimental/Investigational Indications: Cold laser therapy, high-power laser therapy (class IV), and low-level laser therapy using dynamic photonic and dynamic thermokinetic energies are considered experimental and investigational for the following indications due to inadequate evidence of effectiveness:

Individual items enumerated below.

Policy Summary

PayerAetna

PolicyCold Laser and High-Power Laser Therapies

Policy CodePolicy 0363

Change TypeNo material change

Effective Date11/09/1999

Last ReviewFeb 15, 2024

Next Review Date04/11/2024

Key ActionVerify that selected CPT/HCPCS/ICD-10 codes meet the policy's selection criteria and submit indication-specific evidence when requesting prior authorization.

SourceLink

On This Page

Listed indications (enumerated): 1. Achilles tendinopathy; 2. Alzheimer's disease; 3. Bone regeneration/bone healing; 4. Breast implant capsular contracture; 5. Burning mouth syndrome; 6. Cardio-protection following myocardial infarction; 7. Carpal tunnel syndrome; 8. Colorectal cancer; 9. Dementia; 10. Dental pain; 11. Dentin hypersensitivity; 12. Depression; 13. Elbow disorders; 14. Fibromyalgia; 15. Hair loss (including alopecia areata and androgenic alopecia); 16. Head and neck cancer; 17. Heart failure; 18. Herpes labialis; 19. Hypothyroidism induced by autoimmune thyroiditis; 20. Inferior alveolar nerve and lingual nerve injuries; 21. Keratosis pilaris; 22. Knee osteoarthritis; 23. Lymphedema; 24. Melasma; 25. Musculoskeletal dysfunction; 26. Myofascial pain syndrome; 27. Neurological dysfunctions; 28. Neuropathic orofacial pain (eg, burning mouth syndrome, occipital neuralgia, trigeminal neuralgia); 29. Obesity; 30. Oral lichen planus; 31. Oral ulcers in chronic graft-versus-host disease; 32. Pain relief (eg, acute and chronic low back pain/neck pain, orthodontic pain, neuropathic pain, shoulder pain); 33. Parkinson's disease; 34. Patella-femoral pain syndrome; 35. Pemphigus vulgaris; 36. Peri-implant mucositis; 37. Peri-odontitis; 38. Physical therapy including rehabilitation following carpal tunnel release; 39. Plantar fascial fibromatosis; 40. Recurrent aphthous stomatitis/ulcers; 41. Reduction of pain, edema, and trismus after orthognathic surgery; 42. Rheumatoid arthritis; 43. Shoulder impingement syndrome; 44. Skin burn; 45. Stroke; 46. Temporomandibular joint disorders; 47. Tendon repair; 48. Tinnitus; 49. Traumatic brain injury; 50. Wound healing (including diabetic ulcers, following hammertoe surgery, gingival healing, and pressure ulcers).

Enumerated as not covered in the policy text.

Evidence summaries by indication

Evidence summaries by indication (research findings) — useful to derive coverage stance:

Oral mucositis / Maxillofacial surgery: Systematic review evidence indicates LLLT appears effective for prevention/treatment of oral mucositis after head and neck cancer treatment.

Doeuk et al (2015)

Knee osteoarthritis: Meta-analysis of RCTs did not find a significant benefit of LLLT versus sham for pain or WOMAC outcomes in knee osteoarthritis.

Huang et al (2015)

Aphthous stomatitis / Recurrent aphthous ulcers: Systematic review of RCTs reported greater pain reduction and decreased lesion size with laser therapy versus topical medications, but included trials had risk of bias and heterogeneity.

Ahmed et al (2020)

Carpal tunnel syndrome: Meta-analysis found no consistent benefit of LLLT over placebo for primary outcomes (pain, function), though some improvement in grip strength was reported; additional high-quality trials are needed.

Bekhet et al (2017)

Hair loss (MPHL/FPHL): FDA-cleared LLLT devices have RCT evidence supporting safety and effectiveness for male and female pattern hair loss, though number of high-quality trials is limited.

Zarei et al (2016)

Evidence summaries by clinical indication

Evidence summary by indication (not exhaustive):

Diabetic foot ulcers (DFU): Systematic reviews and meta-analyses (multiple RCTs pooled) reported LLLT reduced ulcer area and improved complete healing rates; reported beneficial parameter sets include wavelengths 632.8–685 nm, 50 mW/cm2, 3–6 J/cm2 with irradiation 30–80 seconds, 3x weekly for 1 month; authors call for further high-quality RCTs.parameter examples provided

Li et al (2018); Dos Santos et al (2021)

Oral lichen planus (OLP): Systematic reviews suggest LLLT may reduce symptoms in some trials, but heterogeneity and high risk of bias limit confidence and comparisons versus corticosteroids are inconsistent.

Evidence weak and preliminary.

Recurrent herpes labialis (RHL): Small trials suggest lasers may decrease pain and shorten recurrence interval without reported adverse effects, but studies are heterogeneous and larger double-blind RCTs are needed.

Preliminary trials reported

Low back and neck pain: Clinical guidelines advise against offering LLLT alone for neck pain; systematic reviews found moderate short-term improvements in some trials but no consistent intermediate- or long-term benefit; evidence for low back pain shows low strength for short-term improvements only.

OPTIMa Collaboration; AHRQ systematic review

Breast implant capsular contracture: A phase-II double-blind RCT showed no benefit of LLLT over placebo for most patient- and clinician-reported outcomes, indicating lack of efficacy for this indication.

Azimi et al (2018)

Other indications (eg, obesity, pemphigus, wound healing, peri-implant mucositis, periodontitis, tendon repair, nerve injury, burns, transcranial PBM): Preclinical and small clinical studies report potential biological effects and occasional clinical improvements, but heterogeneity in parameters, small samples, and methodological limitations mean evidence is insufficient for definitive coverage recommendations.

Evidence preliminary or inconclusive.

Evidence summaries and conclusions by clinical indication (background)

Evidence summaries and conclusions by clinical indication (presented as background evidence only):

Tendon repair (preclinical): Preclinical animal studies show LLLT, alone or combined with adipose-derived mesenchymal stem cells, altered remodeling gene expression and improved collagen organization; further mechanistic and translational studies are needed.

Lucke et al (2019)

Brain photobiomodulation / transcranial LLLT (tLLLT): Animal studies demonstrate improved cognition, neurogenesis, and BDNF after tLLLT; small clinical trials exist but broader testing is needed and delivering therapeutic doses to brain tissue is challenging due to attenuation.

Hennessy et al (2017)

Fibromyalgia: Systematic review/meta-analysis of RCTs found LLLT associated with improvements in pain and function versus placebo, but studies had methodological limitations and heterogeneity; additional standardized trials are required.

Summarized trials (9 RCTs)

Tinnitus: Systematic reviews/meta-analyses show inconsistent results across studies and the effect on tinnitus severity remains unclear; no recommendation can be made pending larger, higher-quality trials.

Multiple small studies reviewed

Achilles tendinopathy: Available RCTs provide very low to low certainty evidence and are insufficient to support routine use of laser therapy for Achilles tendinopathy.

Meta-analysis of 4 RCTs (119 subjects)

Burning mouth syndrome (BMS): Systematic review of RCTs found mixed results with diverse parameters; some studies show benefit but standardized protocols and further trials are needed.

Multiple small RCTs summarized

Keratosis pilaris: Case series and small studies suggest lasers may be promising but evidence is limited; UpToDate lists laser as third-line therapy with temporary improvements.

Small observational studies

Melasma: Systematic reviews identify promising evidence for laser/light therapies for vascular components of melasma, but more rigorous trials are needed.

Evidence preliminary

Oral ulcers in chronic GVHD: Retrospective series reported substantial immediate pain reduction after intra-oral photobiomodulation with no adverse effects; randomized placebo-controlled trials are recommended to validate findings.

Retrospective series (11 patients, 56 sessions)

Orthognathic surgery (IAN neurosensory recovery): Systematic reviews report LLLT may improve neurosensory disturbance and some postoperative outcomes after orthognathic surgery, but heterogeneity and limited quality warrant further high-quality trials.

Barbosa et al (2022) - 15 RCTs reviewed

High-power (class IV) lasers - general stance: High-power class IV therapeutic lasers are promoted for multiple musculoskeletal indications but evidence is limited; systematic reviews found little support for routine adjunctive use compared with standard care.

Limited high-quality evidence; further trials needed

Aetna considers cold laser therapy (low‑level laser therapy, LLLT) and high‑power (class IV) laser therapy experimental and investigational for a broad list of clinical indications because of inadequate evidence of effectiveness. The policy enumerates numerous specific conditions under the experimental/investigational heading, including but not limited to Achilles tendinopathy, bone regeneration/bone healing, breast implant capsular contracture, burning mouth syndrome, carpal tunnel syndrome, knee osteoarthritis, lymphedema, oral lichen planus, peri‑implant mucositis, plantar fascial fibromatosis, tinnitus, tendon repair, and wound healing (including diabetic ulcers).

Several specialty reviews and technology assessments cited in the document concluded that LLLT does not meet established evidence or guideline thresholds for certain conditions. Examples include technology evaluation findings and randomized trials that informed the conclusion that LLLT is not recommended as a therapeutic option for carpal tunnel syndrome and that systematic evidence reviews do not support routine use for chronic neck pain or knee osteoarthritis.

Although the source text does not always provide a formal exclusion statement for every indication, the lack of consistent benefit in high‑quality studies informs exclusion implications. For example, a KOA meta‑analysis of randomized trials found no significant difference versus sham for pain or WOMAC outcomes, and CTS meta‑analyses reported inconsistent benefit for pain and function (grip strength improved in some trials but primary outcomes were not consistently better). These negative or heterogeneous findings support treating KOA and primary CTS indications as unsupported by current evidence unless higher‑quality data are provided.

Clinical reviewers and guideline panels have raised oncology safety considerations for photobiomodulation/LLLT. Although some reviews propose potential utility for managing head and neck cancer treatment–related complications, authors caution that the impact of PBM on tumor behavior and tumor response to treatment has been insufficiently studied and that vigilance is warranted. Notably, the NCCN guideline excerpted does not list LLLT as a management option, reflecting an absence of endorsement rather than an explicit policy exclusion.

A phase‑II double‑blind randomized controlled trial evaluated LLLT for breast implant capsular contracture and found no significant benefit of active LLLT over placebo for most patient‑ or clinician‑reported outcomes; the authors concluded LLLT was not effective for this indication.

In reviews addressing plantar fascial fibromatosis (Ledderhose disease), laser therapy is not described as a therapeutic option. The cited literature and an UpToDate summary list conservative care, injections, radiation, ESWT, and surgery as approaches—laser therapy is not mentioned as a standard treatment in these sources.

The document presents evidence summaries by indication rather than explicit blanket coverage exclusions in many sections. These chunks summarize systematic reviews and randomized trials across diverse conditions (e.g., oral mucositis, aphthous stomatitis, carpal tunnel syndrome, and hair loss) and serve as the evidentiary basis for coverage conclusions elsewhere in the policy, but the excerpts themselves primarily report study findings and methodological limitations without always stating formal noncoverage language.

This Clinical Policy Bulletin is intended to assist in the administration of plan benefits; it contains only a partial, general description of plan or program benefits and does not constitute a contract. Participating providers are independent contractors, and the bulletin is not an offer of coverage or medical advice.

Multiple systematic reviews and higher‑quality controlled studies summarized in the document have generally found little or no clinically significant benefit of LLLT for a variety of conditions. The background evidence lists unfavorable or inconclusive results for many musculoskeletal and wound‑healing conditions, supporting the policy’s position that routine use is not supported by robust evidence in those areas.

Systematic reviews and technology assessments referenced in the policy found insufficient evidence to support LLLT for several commonly considered indications. Specifically, evidence syntheses cited concluded that LLLT does not meet criteria for effectiveness in carpal tunnel syndrome, chronic neck pain, and knee osteoarthritis, informing the policy’s not‑medically‑necessary or experimental stance for these conditions.

For knee osteoarthritis and for primary outcomes in carpal tunnel syndrome (pain and functional status), the aggregated trial evidence does not consistently demonstrate benefit. The KOA meta‑analysis reported no significant difference versus sham, and CTS meta‑analyses found improvements in some objective measures (e.g., grip strength) but not in primary pain/function endpoints, supporting that evidence is insufficient to conclude effectiveness for these indications.

Clinical practice guidelines (OPTIMa Collaboration and others) recommend against offering low‑level laser therapy as a standalone treatment for neck pain and associated disorders because evidence does not support its effectiveness, indicating that LLLT should not be used in isolation as a primary therapy for these conditions.

For many musculoskeletal indications promoted for high‑power lasers (class IV), the certainty of evidence is low or very low. Systematic reviews and device background sections note limited scientific support for routine use of high‑power lasers across conditions such as Achilles tendinopathy and various musculoskeletal disorders, and emphasize methodological limitations and heterogeneity in reported protocols.

The provided excerpts primarily summarize trial results and methodological limitations; they do not uniformly contain explicit phrasing that an intervention is ‘not medically necessary.’ Instead, reviewers present evidence strength, heterogeneity, and the need for further well‑designed trials to justify definitive coverage determinations.

Across multiple evidence summaries, the document reports clinical findings and cites references without applying a uniform 'not medically necessary' label within those specific background chunks; formal coverage stances are provided elsewhere in the policy based on the totality of evidence.

Coding and Technical Parameters

Covered CPT CodesCPTCovered

0552T

Low-level laser therapy, dynamic photonic and dynamic thermokinetic energies, provided by a physician or other qualified health care professional.

Not Covered CPT CodesCPTNot Covered

High-power laser therapy (class IV therapeutic laser)

No specific CPT code listed

Related/Neutral CPT Codes (group 1)CPT

97037

Application of a modality to 1 or more areas; low-level laser therapy (ie, nonthermal and non-ablative) for post-operative pain reduction.

Related/Neutral CPT Codes (group 2)CPT

20560	Needle insertion(s) without injection(s); 1 or 2 muscle(s).
20561	Needle insertion(s) without injection(s); 3 or more muscles.

Additional Related CPT Codes (neutral)CPT

No codes listed

Not Covered HCPCS CodesHCPCSNot Covered

S8948

Application of a modality (requiring constant provider attendance) to one or more areas; low-level laser; each 15 minutes.

ICD-10 Codes (mixed coverage status)ICD-10

K12.30-K12.39	Oral mucositis (ulcerative).
B00.9	Herpesviral infection, unspecified.
C18.0-C21.8	Malignant neoplasm of colon, rectum, rectosigmoid junction, anus and anal canal.
E06.3	Autoimmune thyroiditis.
E66.01-E66.9	Overweight and obesity.
G50.0	Trigeminal neuralgia.
G56.00-G56.03	Carpal tunnel syndrome.
H93.11-H93.19	Tinnitus.
I21.01-I23.8	Myocardial infarction.
I50.1-I50.9	Heart failure.

1–10 of 14

1/2

LLLT wavelength and power — technical parameters

Wavelength range600–1000 nm

Power range5–500 mW

Temperature elevationMinimal (≤0.1–0.5°C) due to nonthermal irradiation

Example dosimetry parameters reported in trials

Reported wavelength range in trials632.8–685 nm

Energy density (fluence) reported1.8–3.0 J/cm2

Power reported10–60 mW

Spot/total energy examples0.8–3.0 J per spot; preventive example: 660 nm, 3.8 J/cm2, 15 mW; 0.15 J

Preclinical PBM dosing example (mouse study)

Preclinical modelHigh‑fat diet (HFD) obese mice model

Wavelength and irradiance780 nm, 250 mW/cm2

Fluence and per-site energy10 J/cm2; 0.4 J per site

Treatment frequency/total daily doseOnce daily to 5 locations (40 s each), 5 days/week for 4 weeks; ~2 J total dose per day

Provider Actions, Prior Authorization, and Billing Guidance

Billing Rule

Code-specific coverage guidance (verify selection criteria)

Codes are code-specific: certain CPT/HCPCS/ICD-10 codes are listed as covered only when selection criteria are met and others are listed as not covered for CPB indications. Verify the code-level selection criteria and ensure submitted codes match the indication and documentation.

Covered when selection criteria met: e.g., 0552T (LLLT dynamic photonic/thermokinetic energies) and specified ICD-10 ranges for oral mucositis (K12.30-K12.39).
Not covered examples: S8948 (LLLT each 15 minutes), and listed ICD-10 diagnoses such as B00.9, C18.0-C21.8, E06.3, E66.01-E66.9, etc.

Prior Authorization

Prior authorization likely required where LLLT is considered

Prior authorization is likely required for many indications where LLLT/PBM is considered due to low or inconclusive evidence and to ensure appropriate use and documentation before payment.

Recommend prior authorization for indications with heterogeneous or low-quality trial evidence (e.g., chronic low back pain, neck pain, CTS, KOA).
For oncology-related uses or oral mucositis prevention in HNC, require review of risk/benefit and tumor‑neutrality rationale before approval.

Prior Authorization

Prior authorization required for LLLT: submit indication-specific evidence

When prior authorization is required for LLLT, submit indication-specific evidence including clinical rationale, prior conservative therapies tried, and laser treatment parameters that match supportive studies (wavelength, power, fluence, energy per point, session duration and frequency).

Include documentation of prior conservative therapy and failure or intolerance when applicable (e.g., complex physical therapy, manual lymphatic drainage for lymphedema; guideline-directed therapies for KOA, pattern hair loss).
Provide trial- or device-level evidence showing matching dosimetry (wavelength, irradiance, J/cm2, sessions) to published supportive RCTs/meta-analyses.
Report baseline and planned outcome measures and timepoints (e.g., VAS, WOMAC, wound area reduction, BCTQ, pain scores).

Documentation Required

Evidence insufficient to define prior authorization codes

Evidence is insufficient to map to specific prior authorization billing codes; the source does not define explicit authorization codes. Use existing code guidance but require clinical justification and dosimetry details in authorization requests.

No explicit PA CPT/HCPCS code list is provided in the source — authorization decisions should be based on indication, supporting evidence, and alignment of treatment parameters with published studies.
When codes for high‑power/class IV lasers or LLLT are billed, review submitted clinical rationale rather than relying on a discrete PA code list.

Note

Prior authorization not specified in this section

Portions of the source do not explicitly specify prior authorization requirements. Where PA is not specified, use standard plan processes and consider clinical evidence strength when determining PA need.

Some background sections describe devices and evidence but do not state PA rules; document-level absence of PA language does not preclude plan-level PA policy.
Communicate to providers that absence of PA language in the CPB does not guarantee coverage and requests may still require review.

Note

Prior authorization not specified in this excerpt

Certain excerpts similarly lack explicit prior authorization statements; note these are background and evidence summaries only and do not provide authorization triggers.

Treat background evidence excerpts (e.g., orthognathic surgery recovery, plantar fibromatosis) as informational; require submission of clinical justification for coverage consideration.

Denial Risk

CPT/HCPCS/ICD-10 codes listed as 'not covered' may trigger denial

CPT/HCPCS/ICD-10 codes listed as 'not covered' in the CPB may trigger claim denial when billed for the listed indications. Providers should confirm medical necessity and authorization prior to billing.

Examples of not-covered codes: S8948, and other CPT codes listed as not covered for CPB indications.
If billed for non-covered indications, claims may be denied.

Denial Risk

Lack of evidence of effectiveness for knee osteoarthritis

Lack of evidence of effectiveness for knee osteoarthritis and other conditions is documented and may form the basis for denial of LLLT for those indications.

Meta-analyses for KOA found no significant benefit of LLLT over sham for pain or function (WOMAC, VAS).
For KOA, require failure of guideline-recommended therapies before considering LLLT; absence of supportive evidence may lead to denial.

Denial Risk

Meta-analyses show no significant benefit for some indications (e.g., CTS)

Meta-analyses for carpal tunnel syndrome and some other conditions show no significant benefit over placebo for primary outcomes; use these findings when evaluating authorization and coverage requests.

Bekhet et al (2017) meta-analysis found no significant improvement in pain or functional status for CTS with LLLT compared to placebo.
Cochrane reviews and low-quality heterogeneous trials for post-operative CTS rehabilitation provide limited support for laser modalities.

Documentation Required

Oncology safety vigilance for PBM/LLLT

Oncology applications (e.g., PBM for head and neck cancer or oral mucositis) require vigilance: while some trials show benefit in preventing oral mucositis, tumor‑neutrality is not fully established and careful documentation of intent and safety data is required.

For HNC patients, include tumor‑neutrality discussion and reference trials showing OM prevention (dosimetry ranges reported: ~632–685 nm, varied J/cm2 and power).
Require oncology team concurrence and documentation that PBM will not interfere with tumor control when authorizing use in cancer patients.

Denial Risk

Ineffective therapy evidence may lead to denial

Ineffective therapies identified in RCTs (e.g., breast implant capsular contracture) may result in coverage denial; submit high-quality evidence showing benefit for the specific indication to overcome denial risk.

RCT evidence found LLLT was not effective for breast implant capsular contracture; cite negative RCTs when recommending denial.
Require robust RCT evidence to support coverage for indications with published negative trials.

Note

No explicit authorization or denial triggers stated in these portions

The document contains no explicit authorization or denial triggers in several sections; emphasize that limited scientific support and trial heterogeneity may affect claims and authorization outcomes.

Many trials are small, heterogeneous, or at risk of bias — use caution when extrapolating benefit across populations.
When explicit triggers are absent, rely on plan-level medical necessity criteria and request trial-level justification.

Note

Clinical Policy Bulletins are informational and affect coverage administration

Clinical Policy Bulletins (CPBs) assist in administering plan benefits but are informational and not a contract. Providers remain responsible for clinical decision-making; lack of CPB adherence may affect coverage determinations.

CPBs do not substitute for individualized medical advice or guarantee coverage.
Participating providers are independent contractors; submit complete documentation to support coverage.

Documentation Required

Trials frequently lacked clear randomization/blinding details — include trial-level justification

Trials reviewed were frequently heterogeneous and of low quality (often lacking clear randomization, allocation concealment, blinding, and with small samples). Authorization requests should include trial-level or clinical justification addressing these limitations.

Document how the proposed treatment aligns with higher-quality evidence or explain why lower-quality studies are applicable.
Include details on randomization/blinding or explain mitigation of bias if relying on specific studies.

Documentation Required

Require laser dosimetry and outcome reporting in authorization requests

Authorization requests must include laser dosimetry and outcome reporting: wavelength, power, fluence/J per point, irradiance, spot size, session duration, frequency, and planned outcome measures/timepoints to demonstrate alignment with supportive studies.

Provide device model and parameters (e.g., 632.8–685 nm, 1.8–3.8 J/cm2, 10–60 mW, irradiation time, sessions per week) when applicable.
Report intended clinical outcome metrics (e.g., VAS, wound area reduction, BCTQ) and timeline for assessment.

Documentation Required

Document laser parameters and outcomes

Document laser parameters and outcomes in the medical record and in PA submissions; many trials/meta-analyses specify wavelength, power, fluence, session duration and frequency as critical to interpreting efficacy.

Include pre/post measures (e.g., pain 0–10 scale immediately before/after, WOMAC, ulcer size) and planned follow-up intervals.
If parameters differ materially from those in supportive literature, provide rationale for the alternative protocol.

Documentation Required

Example outcome measurement from retrospective PBMt study

Example outcome measurement from a retrospective PBMt study: pain assessed on a 0–10 scale immediately before and after treatment showed a median 73% reduction in pain with effects lasting an average of ~6.5 days; such measures are useful supporting data but require higher‑level confirmation.

Retrospective cGVHD oral ulcer series (11 patients, 56 sessions) reported pre/post pain scores (mean 5.20 to 1.38) and duration of benefit; report similar measures if available.
Retrospective or case series alone are insufficient for routine coverage decisions — prefer RCTs or robust comparative evidence.

Step Therapy

Require prior conservative therapies before LLLT for applicable indications

More intensive, established conservative therapies should generally be tried and documented before LLLT is considered for conditions where those therapies are standard (e.g., complex physical therapy, manual lymphatic drainage for lymphedema).

Require documentation of prior conservative therapy and inadequate response or intolerance (e.g., complex PT, pneumatic pumps, compression garments for lymphedema).
For KOA, require failure of guideline-recommended therapies before approving LLLT.

Step Therapy

Require failure/intolerance to standard therapies before LLLT for alternative-standard indications

For indications with established standard therapies (e.g., pattern hair loss, knee osteoarthritis), require failure or intolerance to those therapies before approving LLLT as an alternative.

For androgenic alopecia, LLLT devices have FDA clearance and may be considered when patients fail or cannot tolerate topical minoxidil or finasteride; provide prior treatment history.
For KOA and other conditions with guideline treatments, require documented failure/intolerance to standard care.

Step Therapy

Sequencing not specified; follow plan-level protocols

Sequencing and formal step-therapy protocols are not specified in the source. Where the CPB is silent on sequencing, follow plan-level step therapy or utilization management protocols.

The CPB does not define step counts or exact sequencing; authorization should reference plan step-therapy rules if present.
Document prior therapeutic steps attempted even when the CPB does not mandate a specific sequence.

Step Therapy

No step therapy protocols are described in this source

No explicit step therapy protocols are described in the document. Providers should not assume a defined step-therapy pathway from the CPB and must provide clinical history of prior therapies.

Because the CPB lacks step-therapy protocols, utilization review will rely on submitted clinical history and plan-level requirements.
If plan-level step therapy exists, adhere to that protocol when requesting authorization.

Background, Definitions, and Technology Description

Low‑level laser therapy (LLLT), also called photobiomodulation or 'cold' laser, uses nonthermal red or near‑infrared wavelengths, typically in the 600–1000 nm range, with device power outputs commonly between 5 and 500 mW. These parameters are theorized to modulate inflammation, provide analgesia, and stimulate tissue repair without significant thermal tissue damage.

Definition — Low level laser therapy (LLLT / cold laser)

TermLow‑level laser therapy (LLLT) / cold laser

DefinitionUse of red or near‑infrared nonthermal lasers to deliver light (600–1000 nm) at low power (5–500 mW) that penetrates tissue without heating or causing burns

Therapeutic intentProposed to produce analgesia and stimulate healing/biostimulatory effects without thermal tissue damage

Definition — High‑power laser therapy (class IV)

TermHigh‑power laser therapy (class IV)

Power characteristicsClass IV therapeutic lasers with power outputs up to ~7,500 mW

DistinctionDistinct from class III 'cold' lasers; promoted for deeper penetration and larger treatment areas but not to be confused with class IV surgical lasers

Definition — LLLT shorthand entry

ShorthandLLLT (low‑level laser therapy)

Also calledCold laser therapy or class III low‑energy lasers

Key parametersRed/NIR light, nonthermal, low power delivery (600–1000 nm; 5–500 mW)

Definition — LLLT described as phototherapy

Mechanism/intentPhototherapy intended to modulate inflammation, provide analgesia, and stimulate tissue repair (biostimulatory effects)

Nonthermal actionDelivered without heating the tissue (minimal temperature elevation)

Clinical applications investigatedArthritis, tendinopathy, chronic pain, wound healing, oral mucositis and dental/maxillofacial indications

Definition — WALT dosing guidance referenced

Source of dosing guidanceWALT (World Association of Laser Therapy) recommendations referenced in KOA studies

ContextSome KOA trials reported analyses conforming to WALT recommendations; dosimetry heterogeneity remains an issue

Evidence noteTrials conforming to WALT in KOA did not demonstrate clear benefit in pooled analyses

Definition — Photobiomodulation (PBM) / LLLT overview

TermPhotobiomodulation (PBM) / LLLT

DefinitionUse of low‑level lasers or light‑emitting devices to stimulate biological responses (wavelengths and dosimetry vary) applied to tissue healing, pain modulation, and other effects

Evidence caveatDevices, parameters, and protocols are heterogeneous; clinical evidence is inconsistent across indications

Definition — Photobiomodulation / transcranial LLLT (tLLLT)

TermTranscranial photobiomodulation (tLLLT / transcranial PBM)

DefinitionDelivery of red/near‑infrared light to the head to stimulate neuronal mitochondrial activity, neurogenesis, and anti‑inflammatory signaling via photon absorption in mitochondria and ion channels

Research statusPromising preclinical results and small clinical trials; broader clinical testing needed

Definition — Transcranial PBM / tLLLT additional definition content

Additional mechanism detailtLLLT effects include up‑regulation of signaling pathways, increased BDNF, neuro‑progenitor proliferation and synaptogenesis in animal models

LimitationsDose delivery to brain is challenging due to tissue attenuation; clinical translation requires further study

Applications under studyTBI, Alzheimer disease, depression, Parkinson disease, stroke, cognitive enhancement

Definition — High-power (class IV) therapeutic laser technical note

Power capacityUp to approximately 7,500 mW output for class IV therapeutic lasers

Claimed effectsPurported deeper penetration and larger surface treatment areas compared with class III devices

Distinction noteNot to be confused with class IV surgical lasers; evidence supporting routine clinical benefit is limited

Definition — High-power laser surface treatment for dental implants

ApplicationSurface treatment of titanium dental implants with a high‑power laser

Proposed effectAlteration of implant topography to optimize protein uptake and potentially enhance osseointegration

Evidence statusHeterogeneous methodologies and results; systematic review concluded technique is promising but further study needed

Definition — LLLT / photobiomodulation usage summary (indications investigated)

Indications investigatedPain, edema, wound healing, nerve recovery, oral mucositis, dental/maxillofacial conditions, musculoskeletal disorders, hair loss, diabetic foot ulcers

Evidence qualityMany indications studied with heterogeneous dosimetry and mixed-quality trials; some RCTs/meta-analyses show benefit for select conditions (eg, oral mucositis, hair loss, DFU) while others show no benefit

Reporting recommendationStudies frequently emphasize need to standardize and report laser parameters (wavelength, power, fluence, duration, frequency) and outcomes

Definition — Clinical Policy Bulletin definition and disclaimer (Aetna)

Document roleClinical Policy Bulletin developed by Aetna to assist in administering plan benefits

DisclaimerNot an offer of coverage, not medical advice, and does not constitute a contract; participating providers are independent contractors

Update noteBulletin may be updated and is subject to change; treating providers remain responsible for medical advice and treatment

Policy Revision History

2024-02-15policy_reviewLatest

Policy last reviewed on 02/15/2024.

1999-11-09effective_date

Policy originally became effective on 11/09/1999.

2024-04-11next_scheduled_review

Next scheduled policy review on 04/11/2024.

The bulletin and its background sections reference recent systematic reviews and literature through 2022, and include an indexed bibliography (reference chunks). The policy notes its last review date and that it may be periodically updated; users should consult the cited literature (e.g., references listed in chunks 126–129) for the most current trial data and systematic review findings.