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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.
No material clinical or coverage changes in this revision.
Coverage Criteria and Evidence Summary
Medical Necessity — Oral Mucositis Prevention
Covered when ALL of the following are met
Experimental and Investigational
Not covered (experimental/investigational) for the following indications
Individual items enumerated below.
Enumerated as not covered in the policy text.
Evidence summaries by indication
Evidence summaries by indication (research findings) — useful to derive coverage stance:
Doeuk et al (2015)
Huang et al (2015)
Ahmed et al (2020)
Bekhet et al (2017)
Zarei et al (2016)
Evidence summaries by clinical indication
Evidence summary by indication (not exhaustive):
Li et al (2018); Dos Santos et al (2021)
Evidence weak and preliminary.
Preliminary trials reported
OPTIMa Collaboration; AHRQ systematic review
Azimi et al (2018)
Evidence preliminary or inconclusive.
Evidence summaries and conclusions by clinical indication (background)
Evidence summaries and conclusions by clinical indication (presented as background evidence only):
Lucke et al (2019)
Hennessy et al (2017)
Summarized trials (9 RCTs)
Multiple small studies reviewed
Meta-analysis of 4 RCTs (119 subjects)
Multiple small RCTs summarized
Small observational studies
Evidence preliminary
Retrospective series (11 patients, 56 sessions)
Barbosa et al (2022) - 15 RCTs reviewed
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
| 0552T | Low-level laser therapy, dynamic photonic and dynamic thermokinetic energies, provided by a physician or other qualified health care professional. |
| High-power laser therapy (class IV therapeutic laser) | No specific CPT code listed |
| 97037 | Application of a modality to 1 or more areas; low-level laser therapy (ie, nonthermal and non-ablative) for post-operative pain reduction. |
| No codes listed |
| S8948 | Application of a modality (requiring constant provider attendance) to one or more areas; low-level laser; each 15 minutes. |
| 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. |
Provider Actions, Prior Authorization, and Billing Guidance
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.
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 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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Policy Revision History
Policy last reviewed on 02/15/2024.
Policy originally became effective on 11/09/1999.
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.
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