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CurrentBlue Cross Blue Shield - KansasPolicy N/A

Hyperbaric Oxygen Therapy (HBOT)

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This medical policy governs coverage and medical necessity criteria for systemic and topical hyperbaric oxygen therapy for Blue Cross and Blue Shield of Kansas members.

Policy Summary

PayerBlue Cross Blue Shield - Kansas

PolicyHyperbaric Oxygen Therapy (HBOT)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 26, 2019

Last ReviewAug 23, 2022

Next Review DateN/A

Key ActionSubmit a predetermination or contact BCBSKS customer service for coverage questions and prior authorization when HBOT is proposed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Wagner ≥3required wound grade (diabetic)

30 daysminimum wound therapy period

1.5-3.0 atmtherapeutic pressure range

3 RCTsRCTs for topical HBOT

RR=1.3osteoradionecrosis pooled benefit

Coverage Criteria and Evidence-Based Stance

Medically Necessary - Systemic HBOT

Systemic hyperbaric oxygen pressurization may be considered medically necessary for ANY of the following:

Medically necessary indications: 1. Acute traumatic ischemia (e.g., crush injuries, reperfusion injury, compartment syndrome); OR 2. Acute carbon monoxide poisoning; OR 3. Acute cyanide poisoning; OR 4. Non-healing diabetic lower extremity wounds meeting subcriteria (see diabetic wounds criteria block); OR 5. Chronic refractory osteomyelitis; OR 6. Decompression sickness; OR 7. Soft-tissue radiation necrosis and osteoradionecrosis; OR 8. Acute gas embolism; OR 9. Gas gangrene (clostridial myonecrosis); OR 10. Pre- and post-treatment for dental surgery of an irradiated jaw (non-implant related); OR 11. Profound anemia when transfusion is impossible or must be delayed.

See individual policy sections for condition-specific guidance and documentation requirements.

Medically Necessary - Diabetic Lower Extremity Wounds

Covered when ALL of the following are met for diabetic lower extremity wounds:

Diabetic lower extremity wound criteria: a. Patient has type 1 or type 2 diabetes and the lower extremity wound is due to diabetes; b. Wound is classified as Wagner grade 3 or higher; c. There are no measurable signs of healing after at least 30 days of an adequate course of standard wound therapy (eg, offloading, dressings, debridement, antibiotics, glycemic control).

Policy Summary

PayerBlue Cross Blue Shield - Kansas

PolicyHyperbaric Oxygen Therapy (HBOT)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 26, 2019

Last ReviewAug 23, 2022

Next Review DateN/A

Key ActionSubmit a predetermination or contact BCBSKS customer service for coverage questions and prior authorization when HBOT is proposed.

SourceLink

On This Page

Wagner grade >= 3; 30 days of standard wound therapy

Documentation should include diabetes diagnosis, wound attribution to diabetes, Wagner grade, and records showing 30 days of adequate standard wound therapy without measurable healing.

Experimental/Investigational - Systemic HBOT

Systemic HBOT is considered experimental/investigational for the following (not an exhaustive list):

Experimental/Investigational indications: Acute osteomyelitis; acute surgical and traumatic wounds; spinal cord injury; traumatic brain injury; inflammatory bowel disease (Crohn disease or ulcerative colitis); brown recluse spider bites; bone grafts; carbon tetrachloride poisoning; cerebrovascular disease (acute or chronic); fracture healing; hydrogen sulfide poisoning; intra-abdominal and intracranial abscesses; lepromatous leprosy; meningitis; pseudomembranous colitis; radiation myelitis; sickle cell crisis/hematuria; demyelinating diseases (eg, multiple sclerosis, ALS); retinopathy adjuncts in sickle cell; pyoderma gangrenosum; acute coronary syndromes; idiopathic sudden sensorineural hearing loss; refractory mycoses; cerebral edema (acute); migraine; in vitro fertilization; cerebral palsy; tumor sensitization for cancer treatments; delayed-onset muscle soreness; idiopathic femoral neck necrosis; chronic arm lymphedema post-radiotherapy; radiation-induced head and neck injury (except dental surgery of irradiated jaw); early treatment to reduce radiotherapy adverse effects; autism spectrum disorders; bisphosphonate-related osteonecrosis of the jaw; acute ischemic stroke; motor dysfunction after stroke; herpes zoster; vascular dementia; fibromyalgia; compromised skin grafts or flaps; necrotizing soft tissue infections; acute thermal burns; chronic wounds other than specified diabetic wounds; acute arterial peripheral insufficiency; mental illness (PTSD, anxiety, depression); Bell's palsy; retinal artery insufficiency (acute).

Use for these indications is considered experimental/investigational per policy and is generally not covered.

Topical HBOT - Not Covered

Topical hyperbaric oxygen therapy coverage stance

Topical HBOT: Topical hyperbaric oxygen therapy is considered experimental/investigational and is not covered.

Topical HBOT is distinct from topical oxygen wound care and related disposable appliances (eg, HCPCS A4575); the policy explicitly classifies topical HBOT as investigational.

Systemic HBOT - Recommended Indications (UHMS)

UHMS 2019 recommended indications (informational):

UHMS indications: Air or gas embolism; Carbon monoxide poisoning (and carbon monoxide complicated by cyanide); Clostridial myositis/myonecrosis (gas gangrene); Crush injury, compartment syndrome, and other acute traumatic ischemias; Decompression sickness; Central retinal artery occlusion; Diabetic foot ulcer; Healing of other problem wounds; Severe anemia; Intracranial abscess; Necrotizing soft tissue infections; Refractory osteomyelitis; Delayed radiation injury (soft tissue and bony necrosis); Compromised grafts and flaps; Acute thermal burn injury; Sudden sensorineural hearing loss.

Listed for informational reference to UHMS 2019 guidance; payer coverage decisions are determined by policy.

Topical HBOT - Evidence Summary

Topical HBOT for wounds, burns, or infections:

Topical HBOT evidence: Systematic reviews identified 3 RCTs of topical oxygen therapies with heterogeneous populations and regimens; small trials reported improved healing in some chronic wound populations, but data are heterogeneous and a small RCT for diabetic foot ulcers showed no differences. Overall evidence is insufficient to conclude a net health benefit for topical HBOT across indications.

Insufficient controlled evidence to support coverage.

Chronic diabetic foot ulcers (evidence synthesis)

Evidence summary-based conclusions for chronic diabetic foot ulcers

Chronic diabetic foot ulcers - evidence summary: Systemic HBOT compared with standard care in randomized trials and meta-analyses showed higher wound healing rates in pooled analyses and, in some reviews, a lower rate of major amputation; trials were heterogeneous and had methodological limitations; longer follow-up (≥1 year) is necessary to confirm durable clinical benefit.evidence: pooled RCTs/meta-analyses; follow-up >=1 year preferred

See systematic reviews by Sharma et al (2021), Kranke et al (2015), and Elraiyah et al (2016).

Carbon monoxide poisoning (evidence synthesis)

Evidence summary-based conclusions for carbon monoxide poisoning

Acute carbon monoxide poisoning - evidence summary: A Cochrane review of 6 RCTs found no significant pooled effect of HBOT on neurologic outcomes and rated the quality of evidence very low; a large retrospective cohort (Nakajima et al 2020) found no difference in in-hospital mortality though some secondary functional outcomes favored HBOT.evidence: pooled RCTs (inconclusive) and large cohort (no mortality benefit)

Evidence does not conclusively demonstrate improved net health outcomes.

Evidence summaries relevant to coverage

Evidence-based findings relevant to HBOT coverage decisions for radionecrosis, osteoradionecrosis, and irradiated jaw:

Radiation injury evidence - RCT findings: Randomized trials (14 RCTs identified for late radiation tissue injury) show pooled benefits for some outcomes: higher rate of complete mucosal cover after HBOT for osteoradionecrosis (RR=1.3) and lower risk of wound dehiscence after mandibular osteoradionecrosis surgery (RR=4.2); single trials also showed higher likelihood of successful healing for tooth extraction in irradiated jaws.

Evidence moderate for select pooled outcomes; trial numbers limited for some endpoints.

Observational evidence: Observational cohorts and case series report improved healing for radiation-induced skin necrosis and xerostomia, but interpretation limited by lack of comparators and high risk of bias.

Controlled data preferred for coverage determinations.

Chronic refractory osteomyelitis: No RCTs identified; evidence is from case series reporting high drainage-free and infection-control rates over long follow-up (eg, 80–89% success in series), but controlled studies are needed to determine comparative benefit.

Evidence base limited to case series.

Evidence summaries by indication

Evidence summaries and implications by indication

Chronic refractory osteomyelitis: Only case series evidence is available; series report high rates of successful outcomes after many HBOT sessions but no prospective comparative trials were identified, limiting conclusions on net health benefit.

Controlled trials needed.

Acute thermal burns: Two small, methodologically poor RCTs were identified and systematic reviews concluded evidence is insufficient to determine if HBOT improves health outcomes in acute thermal burns.

Not supported for routine use based on current evidence.

Acute surgical and traumatic wounds: Systematic reviews identified four RCTs and additional nonrandomized studies with heterogeneous populations and regimens; heterogeneity prevented pooling and limited conclusions about clinical benefit.

Additional high-quality RCTs required.

Evidence summaries by indication

Evidence-based summary for specific indications (coverage depends on strength of evidence and payer adjudication):

Acute surgical and traumatic wounds: Systematic reviews identified RCTs with heterogeneity that prevent pooled conclusions; evidence is insufficient to conclude net health benefit.

See Eskes et al (2013) and Dauwe et al (2014).

Bisphosphonate-related osteonecrosis of the jaw: One unblinded RCT reported short-term improvements at 3 months with HBOT adjunct but no significant long-term benefits (6–18 months); methodological limitations limit conclusions and longer follow-up is desired.>= 1 year follow-up desired

Freiberger et al (2012) showed early benefit but not sustained differences.

Necrotizing soft tissue infections: No RCTs identified; pooled analyses of retrospective cohorts suggest reduced in-hospital mortality (OR ~0.44) but are subject to publication bias and confounding; other outcomes inconsistent.

Observational evidence only; interpret with caution.

Evidence-based stance by indication

Evidence summaries and policy stance are based on systematic reviews of RCTs and observational studies; results are insufficient or inconsistent to confirm net health benefit for several acute indications.

Necrotizing soft tissue infections: No randomized controlled trials; retrospective cohort data with methodological limitations suggest possible reduced in-hospital mortality but are susceptible to bias and confounding.

Evidence inconclusive.

Acute coronary syndrome: Cochrane review of small RCTs (N~665) found some pooled mortality benefit in limited analyses but overall evidence insufficient and inconsistent; larger, higher-quality trials needed.

Trials used HBOT 2–3 ATA for 30–120 minutes.

Acute ischemic stroke: Cochrane pooled analyses of RCTs found no mortality benefit at 3–6 months; heterogeneity and limited data prevent firm conclusions that HBOT improves survival or functional outcomes.follow-up 3-6 months

Additional RCT evidence required.

Evidence-based coverage summaries for neurologic indications

Summary coverage-relevant conclusions drawn from available evidence for each neurologic indication:

Acute ischemic stroke: Pooled RCT analyses found no significant mortality difference at 3–6 months between HBOT and control; evidence insufficient to support routine coverage for mortality benefit.follow-up 3-6 months

See Bennett et al (2014).

Motor dysfunction associated with stroke: One small crossover RCT (Efrati et al 2013) reported improved NIH Stroke Scale and ADL measures at 2 months with HBOT versus delayed treatment, but methodological limitations (small size, not double-blind, short follow-up) limit conclusions; larger blinded trials with longer follow-up are needed.follow-up >=3 months recommended

Evidence insufficient for routine coverage.

Bell palsy: A Cochrane review identified no eligible blinded RCTs; existing trials lacked blinded outcome assessment—evidence insufficient to support HBOT for Bell palsy.

Well-conducted RCTs needed.

Traumatic brain injury (TBI): Systematic reviews show mixed results: some pooled analyses suggest improved GCS change or reduced mortality, but functional outcomes are not consistently improved; trials vary in quality and many lack sham controls. Longer follow-up (>=1 year) and higher-quality RCTs are required to establish benefit.>= 1 year follow-up recommended

Evidence inconsistent and at risk of bias.

Bell Palsy — Insufficient Evidence

Bell Palsy — evidence summary

Bell palsy evidence: There is a lack of reliable evidence to support HBOT for Bell palsy; systematic review(s) found no eligible high-quality RCTs (the single RCT identified had unblinded outcome assessment), and well-conducted randomized trials are needed.

Not supported by current evidence.

Traumatic Brain Injury — Mixed/Insufficient Consistent Evidence

Traumatic Brain Injury — evidence summary

TBI evidence and follow-up: Systemic HBOT evidence for TBI is inconsistent: some pooled analyses report improved GCS change and reduced mortality, but functional outcomes often do not improve; trials vary in quality, many lack sham controls or blinding, and longer follow-up (>=1 year) is considered necessary to assess functional outcomes.>= 1 year follow-up recommended

Current evidence does not establish consistent clinical benefit.

Military mTBI trials: Several randomized trials in U.S. service members for mild TBI found no significant differences between HBOT and low-pressure sham in many outcomes; pooled analyses of DoD data show inconsistent domain-specific improvements.

Blinding and sham controls influenced trial findings.

Inflammatory Bowel Disease — Evidence Question Framed

Inflammatory Bowel Disease — context

IBD evidence context: HBOT has been evaluated as an adjunct to standard medical and surgical therapies for IBD; only one small open-label RCT (N=18) was identified and found no significant improvement in Mayo score or secondary outcomes; systematic reviews note high risk of bias and heterogeneity in protocols.

Evidence insufficient to support routine coverage.

Systemic HBOT for Inflammatory Bowel Disease

Evidence-based considerations from systematic reviews and RCTs

IBD (ulcerative colitis/Crohn disease): Only one small RCT (open-label, N=18) compared HBOT plus medical therapy to medical therapy alone and found no significant improvement in Mayo score or secondary outcomes; systematic reviews identified heterogeneous protocols and high risk of bias; longer-term follow-up (>=1 year) is necessary to demonstrate efficacy.RCT N=18; follow-up >=1 year suggested

Current evidence does not support routine use.

Systemic HBOT for Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)

Evidence for HBOT as adjunct to medical therapy in ISSNHL

ISSNHL response: Systematic reviews and meta-analyses report mixed results: some pooled analyses found improved rates of hearing recovery when HBOT is added to medical therapy (steroids), particularly in severe/profound hearing loss, while other reviews cautioned about small trials, heterogeneity, and risk of bias; benefit appears greater in severe/profound cases and definitions of recovery varied across studies.varied by study (eg, >=10-point audiometric gain; >25% or >50% recovery)

Coverage considerations should account for severity, prior therapy, and documentation of expected benefit.

Idiopathic Sudden Sensorineural Hearing Loss

Summary findings for ISSNHL

ISSNHL evidence summary: Patients with severe or profound hearing loss who received steroids plus HBOT in several studies often had statistically significant improvements in hearing recovery; patients with lesser degrees of hearing loss did not consistently benefit.severity of hearing loss (severe/profound)

Evidence quality limitations warrant cautious, case-by-case coverage consideration.

Delayed-Onset Muscle Soreness

Top-line findings for delayed-onset muscle soreness (DOMS):

DOMS evidence summary: Cochrane review pooled RCTs and found significantly higher short-term pain at 48 and 72 hours with HBOT versus control and no long-term benefit; overall, HBOT does not demonstrate clinical benefit for DOMS.short-term pain worse with HBOT; follow-up >=1 month recommended

Not supported for DOMS.

Autism Spectrum Disorder

Summary findings for autism spectrum disorder

Autism evidence summary: A single small low-quality RCT and a subsequent controlled trial did not find significant improvements with HBOT versus sham; available randomized evidence does not support HBOT for autism spectrum disorder.no statistically significant benefit observed; follow-up >=6 months considered where applicable

Not supported for routine coverage.

Autism Spectrum Disorder

Evidence summary and coverage implication

Autism spectrum disorder evidence: Systematic review identified a single small low-quality RCT and another controlled trial; neither demonstrated benefit of HBOT versus sham, and results do not support HBOT for autism spectrum disorder.

Insufficient evidence for coverage.

Cerebral Palsy

Covered when evidence demonstrates clinical benefit — summary of trials for cerebral palsy:

Cerebral palsy evidence summary: Two randomized trials and observational data exist: one double-blind RCT was stopped early for futility and another RCT found similar improvements in HBOT and sham groups; overall randomized evidence does not demonstrate superiority of HBOT for CP. At least 1 year of follow-up is considered necessary to demonstrate efficacy in CP trials.>= 1 year follow-up considered necessary

Current evidence does not support routine coverage for CP.

Vascular Dementia

Evidence summary and coverage implication for vascular dementia:

Vascular dementia evidence summary: A single small RCT (China, N=64) reported improved cognitive scores at 12 weeks with HBOT plus donepezil versus donepezil alone, but the trial was judged poor quality (not blinded; randomization methods unclear) and follow-up was short; evidence insufficient to support coverage without higher-quality longer-term data.>= 1 year follow-up preferred

Insufficient high-quality evidence for routine coverage.

Radiotherapy Adverse Events

Evidence selection framework for radiotherapy adverse events

Radiotherapy adverse events evidence: Comparative trials and observational studies were sought; RCTs and prospective comparative data are preferred for efficacy assessment. Evidence in this area includes RCTs with mixed results and observational cohorts showing symptomatic improvement for some endpoints.

Coverage decisions should consider RCT results where available and require documentation of prior therapies and follow-up.

Coverage considerations based on available evidence

Evidence summary and implications for coverage decisions

Radiotherapy adverse events: Systemic HBOT is considered a treatment option for radiotherapy adverse events; evidence is mixed—some RCTs and observational studies show benefit for specific outcomes (eg, cystitis, improved mucosal cover, reduced wound dehiscence), whereas other outcomes and indications have limited or inconsistent data.evidence mixed; follow-up >=1 year often needed

Documentation should include indication details and planned follow-up.

Idiopathic femoral neck necrosis: One small RCT (n=20) reported mixed short-term improvements in pain and range of motion after 30 sessions, but the trial is insufficient to draw definitive conclusions; at least 1 year of follow-up is considered necessary to demonstrate efficacy.>= 1 year follow-up

Evidence inadequate for routine coverage.

Indication-specific evidence summaries

Evidence summaries and implied coverage considerations by indication

Idiopathic femoral neck necrosis: One small RCT (n=20) with short-term mixed results; improvements in some measures after 30 sessions reported but insufficient evidence and follow-up to support routine coverage.>= 1 year follow-up preferred

Insufficient data for firm coverage decisions.

Migraine headache: Cochrane review of 11 RCTs found immediate symptom relief within 45 minutes in pooled analysis of 3 trials, but trials were heterogeneous and generally low quality; longer-term benefit not demonstrated (>=1 month follow-up recommended for efficacy assessment).>= 1 month follow-up

Not established for routine coverage.

Herpes zoster: One RCT (n=68) reported improved short-term outcomes (therapeutic efficacy, days to blister resolution, scar formation, pain) with HBOT plus medication versus medication alone, but the trial lacked blinding and long-term follow-up; at least 1 year follow-up is preferred to establish sustained benefit.>= 1 year follow-up preferred

Promising short-term signals but insufficient for routine coverage without further evidence.

Evidence summaries by condition

Evidence summaries and findings by condition

Herpes zoster evidence: One RCT (68 patients) showed significantly better short-term outcomes for HBOT plus medication versus medication alone, but limitations include lack of blinding and absence of long-term follow-up.short-term outcomes only

Longer follow-up and higher-quality trials needed.

Fibromyalgia evidence: Two small trials reported improvements in tender points, pain threshold, and quality of life with HBOT, but methodological limitations (quasi-randomization, uncertain sham control) and variable protocols limit confidence; evidence insufficient to conclude net health benefit.insufficient evidence

Sham-controlled trials needed.

Multiple sclerosis evidence: PICO and study selection criteria described but no trial results presented in these excerpts; evidence for MS is not reported here.no evidence reported in this extract

Further data required.

Topical hyperbaric oxygen therapy (topical HBOT) is explicitly designated by this policy as experimental/investigational and is not a covered therapy. Requests for coverage of topical HBOT should be treated as noncovered unless and until supportive, high-quality evidence and a change in policy position are documented.

The policy states that topical hyperbaric oxygen therapy is considered experimental/investigational. As such, topical HBOT is not established as medically necessary and routine coverage is not provided under the terms of this medical policy.

The policy enumerates a broad list of conditions for which systemic HBOT is considered experimental/investigational and therefore not supported for routine coverage. Examples included in the list are: pseudomembranous colitis, radiation myelitis, sickle cell crisis/hematuria, demyelinating diseases (eg, multiple sclerosis, ALS), pyoderma gangrenosum, idiopathic femoral neck necrosis, chronic arm lymphedema post-radiotherapy, radiation-induced head and neck injury (except specified dental surgery of an irradiated jaw), early radiotherapy adjuncts, autism spectrum disorders, bisphosphonate-related osteonecrosis of the jaw, acute ischemic stroke, motor dysfunction after stroke, herpes zoster, vascular dementia, fibromyalgia, compromised skin grafts or flaps, necrotizing soft tissue infections, acute thermal burns, and chronic wounds other than specified diabetic wounds. This list is presented in the policy as indications that are considered experimental/investigational.

Coding, Classification, and Key Clinical Thresholds

Topical HBOT HCPCSHCPCS

A4575

Disposable topical hyperbaric oxygen appliance

Wagner wound grade

Wagner grade requiredWagner grade 3 or higher

Standard wound therapy duration

Standard wound therapy prerequisiteNo measurable signs of healing after 30 days of an adequate course of standard wound therapy

Utilization review triggers

Utilization review — problem woundsUtilization review required after the initial 30 days of treatment for enhancement of healing in problem wounds

Utilization review — decompression/gas embolismUtilization review recommended after 10 treatments for decompression sickness or persistent gas embolism cases

Utilization review — radiation injuryUtilization review recommended after 60 treatments for soft-tissue radiation necrosis and osteoradionecrosis (typical course 30–60 treatments)

Required follow-up duration to demonstrate efficacy

Minimum follow-up to demonstrate efficacy (general)At least 1 year of follow-up is considered necessary to demonstrate efficacy for many indications

Follow-up — radionecrosis/irradiated jawAt least 1 year of follow-up is considered necessary to demonstrate efficacy for radionecrosis, osteoradionecrosis, and treatment of irradiated jaw

Follow-up — chronic diabetic ulcersLonger follow-up (≥1 year) preferred; trials often report varying follow-up up to 22 months

Minimum follow-up for efficacy assessment

Radiation-related injuries≥1 year follow-up recommended for radiation-related injuries

Chronic refractory osteomyelitisFollow-up reported in case series ranged from 34 to 84 months; up to 3–5+ years suggested to assess durability

Case-series follow-upCase series of chronic refractory osteomyelitis reported mean 35–48 treatments with follow-up up to 84 months

Minimum follow-up duration

General minimum follow-up>= 1 year follow-up considered necessary to demonstrate efficacy for multiple indications (e.g., bisphosphonate-related osteonecrosis, acute coronary syndrome, TBI)

Acute ischemic stroke6 months to 1 year or more of follow-up considered necessary to demonstrate efficacy

Traumatic brain injuryAt least 1 year of follow-up is considered necessary to demonstrate efficacy for TBI outcomes

Minimum follow-up duration

Policy minimum follow-up>= 1 year follow-up is considered necessary to demonstrate efficacy in trials for many indications

Bisphosphonate-related osteonecrosisAt least 1 year of follow-up recommended to assess long-term outcomes (RCTs reported to 18 months)

Necrotizing soft tissue infectionsAt least 1 year of follow-up considered necessary given severity of condition

Minimum follow-up recommendations by indication

Follow-up range by indicationAt least 6 months to 1 year of follow-up is considered necessary depending on indication

Acute coronary syndrome preference1 year preferred follow-up for acute coronary syndrome outcomes

Migraine follow-upAt least 1 month of follow-up is considered necessary to demonstrate efficacy for migraine outcomes

Minimum follow-up duration (summary)

Minimum follow-up — policy standard>= 1 year follow-up considered necessary to demonstrate efficacy for radiotherapy adverse events and several other conditions

Femoral neck necrosisAt least 1 year of follow-up is considered necessary to demonstrate efficacy for idiopathic femoral neck necrosis

Herpes zosterAt least 1 year of follow-up is considered necessary to demonstrate efficacy for herpes zoster (only short-term RCT data available)

Mayo score threshold

Mayo score threshold>= 6 indicates moderate-to-severe active ulcerative colitis (Mayo score range 0–12)

Context — IBD RCTOne small open-label RCT (N=18) used Mayo score as primary outcome; no significant difference detected

Use in selectionMayo score ≥6 used to classify moderate-to-severe active disease in trials

Hearing recovery thresholds

Audiometric gain threshold>=10-point audiometric gain used in pooled ISSNHL analyses

Percent recovery thresholds>25% and >50% return of hearing were reported in trials and pooled analyses

Outcome variabilityDefinitions of hearing recovery varied across trials (≥10-point gain, >25% or >50% return); interpret per trial definitions

Minimum follow-up durations

DOMS follow-up requirementAt least 1 month of follow-up is considered necessary to demonstrate efficacy for delayed-onset muscle soreness (DOMS)

Autism follow-up requirementAt least 6 months of follow-up is considered necessary to demonstrate efficacy for autism spectrum disorder outcomes

Trial follow-up variabilityExisting autism trials had short follow-up (e.g., 10 weeks); longer follow-up may show differences

Minimum follow-up to demonstrate efficacy

Follow-up to demonstrate efficacy (general)At least 1 year of follow-up is considered necessary to demonstrate efficacy for multiple indications

Bisphosphonate-related osteonecrosisTrials evaluated outcomes to 12–18 months; policy prefers ≥1 year follow-up for efficacy assessment

Necrotizing infections and radiotherapy injuriesAt least 1 year follow-up considered necessary to assess outcomes

Follow-up duration by indication

Femoral neck necrosis follow-up>= 1 year follow-up considered necessary to demonstrate efficacy (Camporesi RCT reported only 6-week outcomes)

Herpes zoster follow-up>= 1 year follow-up preferred; existing RCT (n=68) reported only short-term outcomes

Migraine follow-upAt least 1 month of follow-up considered necessary for migraine outcome assessment

Minimum follow-up to demonstrate efficacy (fibromyalgia)

Fibromyalgia follow-upAt least 1 year of follow-up is considered necessary to demonstrate efficacy for fibromyalgia

Trial limitationsExisting RCTs were small and had methodological limitations (quasi-randomization or uncertain sham control)

Evidence contextObserved short-term improvements may reflect placebo; longer sham-controlled trials needed

Prior Authorization, Documentation, and Utilization Management

Prior Authorization

Obtain preauthorization/predetermination for systemic HBOT

Systemic HBOT is medically necessary only for the listed covered indications; providers should obtain preauthorization or submit a predetermination request to verify member benefits before initiating therapy.

Policy lists specific covered indications (see policy A.1–11) and states topical HBOT is investigational (policy guideline).
HCBSKS recommends contacting customer service or submitting a predetermination request for coverage questions.

Prior Authorization

Expect utilization review at treatment milestones

Utilization review is required at defined treatment milestones: after the initial 30 days for enhancement-of-healing problem wounds, after 10 treatments for some acute conditions (eg, decompression/gas embolism, gas gangrene), and after 60 treatments for radiation injury.

Utilization review is required after the initial 30 days of treatment and at least once every additional 30 days for enhancement-of-healing problem wounds.
Utilization review is recommended after 10 treatments for decompression/gas embolism and after 60 treatments for soft-tissue radiation necrosis/osteoradionecrosis.

Prior Authorization

Document adjunctive intent and follow-up in prior authorization

When requesting prior authorization for systemic HBOT as adjunctive therapy for wounds, document that HBOT is being used adjunctive to standard or advanced wound care and include the expected follow-up plan (efficacy often requires ≥1 year of follow-up).

Document prior/concurrent standard wound care (offloading, dressings, debridement, antibiotics, glucose control) and planned objective outcome assessment.
Include the HBOT regimen and anticipated follow‑up since trials indicate at least 1 year of follow-up is necessary to demonstrate efficacy.

Prior Authorization

Contact BCBSKS or submit predetermination for coverage questions

Submit a predetermination request or contact Blue Cross and Blue Shield of Kansas customer service for coverage questions or uncertainty about member benefits prior to providing HBOT.

The policy repeatedly directs providers to contact BCBSKS customer service or submit a predetermination request when questions about coverage arise.
No routine review/update is scheduled; predetermination helps resolve case‑specific coverage uncertainty.

Prior Authorization

Seek predetermination for indications with limited evidence

Predetermination or prior authorization is suggested when HBOT is proposed for indications with limited or low‑quality evidence (eg, chronic refractory osteomyelitis, acute thermal burns, acute surgical/traumatic wounds).

Chronic refractory osteomyelitis has no RCTs and evidence is based on case series; predetermination is advised.
Cochrane reviews for thermal burns and acute surgical/traumatic wounds found limited or heterogeneous trials; contact payer for coverage determination.

Note

Use predetermination/contact customer service for coverage inquiries

For coverage questions or predetermination, providers should contact Blue Cross and Blue Shield of Kansas customer service or submit a predetermination request per the policy guidance.

Policy language instructs providers to contact BCBSKS customer service or professional/institutional relations representative for coverage inquiries.
Predetermination is the recommended process when coverage is uncertain.

Note

Predetermination/contact BCBSKS when policy status uncertain

Submit a predetermination request or contact BCBSKS customer service for coverage questions about HBOT; the policy notes no scheduled review and case‑by‑case coverage may apply.

Policy repeatedly advises predetermination/contact for coverage since coverage may be situation‑dependent and no review/update is scheduled.
Providers should verify member contract benefits at time of service.

Prior Authorization

Include indication, prior therapies, and follow‑up plan in authorization

Prior authorization requests should document the indication, prior and concurrent standard treatments tried, and the planned follow‑up and objective outcome measures because trials are small and have limited follow‑up.

Provide diagnosis, prior/concomitant standard therapies (eg, debridement, antibiotics, physical therapy), planned number of HBOT sessions, and objective baseline and follow‑up measures.
Explain planned duration of follow‑up (often ≥1 year) to align with evidence expectations.

Note

Contact payer or institutional relations for coverage decisions

Contact Blue Cross and Blue Shield of Kansas customer service or submit a predetermination request for coverage decisions; providers and institutional reps may be consulted per policy.

Policy directs providers to contact BCBSKS customer service or professional/institutional relations representative when coverage questions arise.
Absence of high‑quality evidence for many indications means payer contact is advisable.

Note

Submit predetermination when coverage questions exist

When coverage is uncertain, predetermination (prior authorization) is recommended; contact BCBSKS customer service or submit a predetermination request to determine coverage.

Policy suggests predetermination where coverage questions exist and lists examples of indications requiring case‑by‑case adjudication.
Document submission supports consistent coverage determinations.

Note

Submit predetermination or call customer service for coverage clarification

Submit a predetermination request or contact customer service prior to treatment when coverage questions arise; the policy repeatedly recommends this step.

Policy guidance: submit predetermination request or contact BCBSKS customer service for coverage inquiries.
Predetermination helps clarify member benefits and reduce denial risk.

Note

Contact BCBSKS or submit predetermination for coverage determination

Contact BCBS of Kansas customer service, your professional/institutional relations representative, or submit a predetermination request when requesting coverage for systemic HBOT.

Policy explicitly directs contacting BCBSKS or submitting predetermination for coverage determination.
Do not proceed without verifying benefits when indications fall outside clearly covered list.

Prior Authorization

Provide long‑term follow‑up evidence for radiation injuries and femoral necrosis

For radiotherapy adverse events or idiopathic femoral neck necrosis, providers should expect that demonstrating medical necessity will require detailed condition documentation and long‑term follow‑up (at least 1 year) in authorization materials.

Documentation should include condition details and outcomes with at least 1 year of follow‑up to support efficacy claims for radiation injuries and femoral neck necrosis.
Policy notes longer follow‑up (34–60 months) may be needed for chronic osteomyelitis.

Note

Recommend predetermination for evidence‑limited indications

When coverage questions exist, contact Blue Cross and Blue Shield of Kansas customer service or submit a predetermination request; predetermination is recommended given evidence limitations.

Policy indicates contacting BCBSKS customer service or submitting predetermination due to evidence limitations for several indications.
Predetermination is recommended to obtain a definitive coverage decision.

Note

Use predetermination to verify HBOT coverage

Submit a predetermination request or contact customer service whenever there are questions about coverage of HBOT services to verify benefits before treatment.

Policy repeatedly advises predetermination or contacting customer service when coverage is uncertain.
Predetermination reduces risk of unexpected claim denials.

Note

Predetermination recommended for non‑routine HBOT use

When coverage questions arise, submit a predetermination request or contact customer service to confirm coverage prior to providing HBOT.

Policy guidance: submit predetermination request or contact BCBSKS customer service for coverage inquiries.
Predetermination recommended for non‑routine indications.

Step Therapy

Document 30‑day standard wound therapy and Wagner grade for diabetic foot ulcers

For diabetic lower extremity wounds, providers must document an adequate 30‑day course of standard wound therapy with no measurable signs of healing, presence of diabetes, and a wound classified as Wagner grade 3 or higher before HBOT is considered.

Policy A.4 requires: diabetes diagnosis, wound due to diabetes, Wagner grade ≥3, and no measurable healing after 30 days of adequate standard wound therapy.
Standard wound care includes offloading, dressings, debridement, antibiotics, and glucose control (document prior attempts).

Step Therapy

Expect topical HBOT regimen and coding (A4575)

Topical HBOT regimens are typically daily cycles (eg, ~90 minutes/day for 4 days, 3‑day break, repeat) and trial regimens varied; topical HBOT is distinct from topical oxygen wound care and uses HCPCS A4575 for the disposable appliance.

Policy guideline notes typical topical regimen: 90 minutes/day for 4 consecutive days, 3‑day break, repeated over 8–10 weeks.
HCPCS A4575 describes a disposable topical hyperbaric oxygen appliance; topical HBOT is considered investigational.

Step Therapy

Document HBOT as adjunct to standard wound care

Systemic HBOT is considered an adjunct to standard wound care (eg, debridement, antibiotics, glucose control) or advanced wound therapies; prior/concurrent standard therapies should be documented when seeking coverage.

Comparators include standard wound care and advanced wound therapies; HBOT is adjunctive in many trials.
Document prior/concurrent standard care and rationale for adjunctive HBOT in authorization materials.

Documentation Required

Record prior standard therapies before adjunctive HBOT

Providers should document prior or concurrent use of standard comparators (eg, debridement, dressings, antibiotics, IV antibiotics, corticosteroids) before adjunctive HBOT is authorized.

Policy states providers should document that standard comparators were considered or trialed prior to adjunctive HBOT.
Include specifics of prior therapies and responses in the clinical record and prior‑auth materials.

Documentation Required

Document adjunctive medical and surgical therapies

When HBOT is used adjunctively, documentation should show adjunctive intent and list the medical and surgical therapies used (eg, antibiotics, antifungals, debridement), including planned HBOT sessions and outcome measures.

Document adjunctive medical therapies and surgical procedures and indicate HBOT is intended as adjunctive treatment.
Include planned number of HBOT sessions and objective outcome measures to be used for follow‑up.

Documentation Required

Include protocol‑like HBOT regimen and objective outcome measures in documentation

Document prior or concurrent standard therapies and objective baseline and follow‑up assessments (eg, wound measures, functional scores); provide a protocol‑like description of the HBOT regimen and expected outcomes.

Provide diagnosis, prior/concomitant therapies (physical therapy, medications), objective baseline and follow‑up functional assessments, and planned follow‑up duration.
Submit HBOT regimen details (pressure, session length, number of sessions) and planned outcome measures to support medical necessity.

Documentation Required

Demonstrate trial of standard comparators before HBOT

Providers should document that standard comparators (eg, wound care dressings, debridement, antibiotics) were considered or trialed prior to adjunctive HBOT authorization requests.

Policy explicitly requires documentation that standard comparators were considered or trialed for wound indications.
This supports stepwise care documentation required for prior authorization.

Denial Risk

Expect denial risk for indications with only case‑series evidence

When coverage is requested for indications supported only by limited or observational evidence (eg, chronic refractory osteomyelitis), anticipate denial risk unless detailed documentation and predetermination justify medical necessity.

Chronic refractory osteomyelitis evidence is case‑series only; claims lacking RCT evidence may be at risk for denial.
Predetermination and detailed long‑term follow‑up documentation (often years) can be required to support coverage.

Billing Rule

Code/topical HBOT correctly (A4575) and note investigational stance

Distinguish topical HBOT from topical oxygen wound care and use HCPCS code A4575 for a disposable topical hyperbaric oxygen appliance when billing; topical HBOT is considered experimental/investigational.

Policy guideline: HCPCS A4575 describes a disposable topical hyperbaric oxygen appliance.
Topical hyperbaric oxygen therapy is considered experimental/investigational per the policy.

Denial Risk

Include ≥1 year follow‑up data or plan to reduce denial risk

Lack of at least 1 year of follow‑up data for chronic diabetic ulcer indications may result in insufficient evidence to demonstrate efficacy and increase risk of denial; include long‑term follow‑up in authorization materials.

Policy states at least 1 year of follow‑up is considered necessary to demonstrate efficacy for chronic diabetic ulcers and many other indications.
Absence of ≥1 year follow‑up is flagged as evidence insufficiency that may prompt predetermination or denial.

Note

Use predetermination for coverage questions given evidence uncertainty

Predetermination requests or contacting BCBSKS customer service may be required for coverage questions; the policy advises predetermination when evidence is uncertain.

Policy repeatedly instructs providers to contact BCBSKS customer service or submit a predetermination request for coverage questions.
When evidence is limited or heterogeneous, predetermination is recommended prior to providing HBOT.

Denial Risk

Provide strong justification for indications with limited evidence to avoid denial

Because evidence is limited or absent for some indications (eg, chronic refractory osteomyelitis), claims may be denied unless additional justification and documentation are provided; expect adjunctive documentation and predetermination.

Policy notes claims lacking RCT evidence for chronic refractory osteomyelitis may be at risk for denial.
Provide detailed case history, prior treatments, and long‑term follow‑up to support medical necessity.

Denial Risk

Anticipate extra review for indications with heterogeneous/poor‑quality evidence

Poor‑quality or heterogeneous trial evidence for acute thermal burns and acute surgical/traumatic wounds may trigger additional payer review or predetermination inquiries; document trial results are limited and provide rationale for HBOT use.

Cochrane and systematic reviews identified small, poor‑quality, or heterogeneous RCTs for thermal burns and acute surgical/traumatic wounds.
Because of evidence limitations, expect additional review and document clinical rationale and prior therapies.

Note

Recommend predetermination when evidence is uncertain or no review scheduled

Because no routine review/update is scheduled and evidence is uncertain for many indications, predetermination is recommended to reduce denial risk—contact BCBSKS customer service or submit a predetermination request.

Policy notes no scheduled review/update and repeatedly recommends predetermination for unresolved coverage questions.
Lack of predetermination may increase risk of coverage denial.

Denial Risk

Document required minimum follow‑up to avoid denial

Insufficient follow‑up (less than the policy's stated minimums, commonly about 1 year) for outcomes may lead to inadequate demonstration of efficacy and coverage denial; include follow‑up plan and outcomes monitoring in requests.

Policy identifies minimum follow‑up requirements (eg, ≥1 year for many indications) and flags insufficient follow‑up as a risk for denial.
Ensure documentation of planned and actual follow‑up to meet payer expectations.

Denial Risk

Expect predetermination or denial when evidence is low‑quality or limited

When evidence is limited (small trials, short follow‑up, methodological limitations), BCBSKS may request predetermination or deny coverage; seek predetermination and submit comprehensive documentation in such cases.

Policy states insufficient or low‑quality evidence may lead to non‑coverage or predetermination requests.
Comprehensive submission should include study‑like protocol, prior therapies, and objective outcome measures.

Note

Background and Definitions

Hyperbaric oxygen therapy (HBOT) delivers 100% oxygen at pressures above atmospheric pressure. It can be administered systemically (the patient is enclosed in a pressure chamber and breathes oxygen at pressures greater than 1 atmosphere, with circulation delivering oxygen systemically) or delivered topically to a localized wound area (topical HBOT applies 100% oxygen directly to an open, moist wound at slight positive pressure via an appliance). Systemic HBOT relies on increased ambient pressure to raise dissolved oxygen in blood for delivery to target tissues, whereas topical HBOT increases local tissue oxygen tension directly at the wound site.