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Hyperbaric Oxygen Therapy

Policy Number: MP-060

Latest Review Date: June 2023

Category: Medical                                                                 

POLICY:

TOPICAL hyperbaric oxygen is considered investigational.

Hyperbaric oxygen therapy may be considered medically necessary when used to treat the following diagnoses:

Diagnosis

Sessions Allowed (120 minutes per session= code billed 4 times per session. )

Air or gas embolism

No more than 10 sessions should be needed to treat.

Carbon monoxide poisoning

In patients with persistent neurologic dysfunction after the initial treatment, subsequent treatments may be performed within 6-8 hours and continued once or twice daily until there is no further improvement in cognitive functioning. No more than 5 sessions should be needed to treat.

Central retinal artery occlusion

HBO must be initiated within 24 hours after initial visual loss. No more than 1 session should be needed to treat.

Clostridial myositis and Myonecrosis (Gas Gangrene)

The decision to terminate treatment depends upon the patient’s response to HBO2 therapy. If the patient remains toxic, the treatment needs to be extended. No more than 10 sessions should be needed to treat.

Crush

Treatment sessions recommended as TID for 2 days, BID for 2 days, and daily for 2 days. No more than 12 sessions should be needed to treat.

Other acute traumatic peripheral ischemias (ATPI)

Treatment same as for crush injuries. No more than 12 sessions should be needed to treat.

Compartment syndromes

No more than 3 sessions should be needed to treat.

Cyanide poisoning, acute

In patients with persistent neurologic dysfunction after the initial treatment, subsequent treatments may be performed within 6-8 hours and continued once or twice daily until there is no further improvement in cognitive functioning. No more than 5 sessions should be needed to treat.

Decompression sickness

The number of treatments required will depend upon (1) the clinical severity of the illness; (2) the clinical response to treatment; and (3) residual symptoms after the initial recompression. Depending on the patient’s initial response, there may be repetitive treatments. Patients should be treated until clinical examination reveals no further improvement in response to the HBO2 treatments. The need for follow up should be supported by documentation of the clinical evaluation before and after each treatment.  No more than 10 sessions should be needed to treat.

Enhancement of healing in problem/refractory wounds; diabetic wounds, venous statis ulcers, decubitus ulcers, and arterial insufficiency ulcers

The initial treatment schedule is dictated by the severity of the disease process. In the presence of limb-threatening infection after debridement or compromised surgical flaps following amputation, the patient should be treated twice daily. When the infection is under control and the soft tissue envelope improves, once daily treatments are adequate. When the suture line of the compromised surgical flap appears stable, daily treatment can be initiated. No more than 30 sessions prior to surgical grafting and not more than 10 sessions post-grafting should be needed to treat.

Exceptional blood loss anemia

HBO2 can be used to treat a patient with severe anemia that cannot receive blood products for medical or religious reasons when the following criteria are met:  (1) mean blood pressure below 60mmHg, or requirement for vasopressors; (2) altered mental status; (3) myocardial ischemia by clinical or electrocardiogram criteria; (4) ischemic bowel; or (5) severe lactic acidosis. The vital capacity should be monitored to assess the extent of pulmonary oxygen toxicity. HBO2 should be discontinued when the red blood cells have been replaced and the signs and symptoms of tissue hypoxia have been alleviated (approximate hemoglobin of 6-8 g/dl). Up to 10 treatments may be recommended. No more than 30 treatments should be needed.

Intracranial abscess

HBO2 treatment is administered from 60 to 90 minutes per treatment. HBO2 treatment may be one or two sessions per day depending on the condition of the individual patient. No more than 20 treatments should be needed to treat.

Necrotizing soft tissue infections (i.e. crepitant anaerobic cellulitis, progressive bacterial gangrene, necrotizing fasciitis, Fournier’s gangrene, non-clostridial myonecrosis synergistic necrotizing cellulitis, brown recluse spider bites)

In the initial phase, they should be given twice daily.  Once the patient’s condition has stabilized, treatments may be given on a daily basis until the infection is controlled.  Because of the nature and general progression of these diseases, and because patient response is often slow, an extended course of HBO2 therapy may be necessary.  No more than 30 treatments should be needed.

Refractory osteomyelitis

The initial treatment depends on the severity of the patient’s clinical disease.  The HBO2 treatments last for 90-120 minutes.  Following major debridement surgery, the patients should be treated daily if possible.  No more than 40 treatments should be needed.

Radiation injury, Delayed (soft tissue and bony necrosis); i.e. mandibular necrosis, laryngeal necrosis and soft tissue necrosis of head and neck, chest wall necrosis, radiation cystitis, radiation proctitis and enteritis, other radiation-induced abdominal and pelvic injuries, radiation injuries of the extremities, radiation injuries of the central nervous system.

No more than 60 treatments should be needed.

Skin grafts and flaps, Compromised

Hyperbaric oxygen therapy is neither necessary nor recommended for the support of normal, uncompromised skin grafts or flaps.  However, in tissue compromised by irradiation or in cases where there is decreased perfusion or hypoxia, HBO2 has been shown to be extremely useful in flap salvage.  HBO2 can help maximize the viability of the compromised tissue, reducing the need for re-grafting or repeat flap procedures.  The treatments are from 90-120 minutes.  Initial treatment should be twice daily.  Once the graft or flap appears more viable and stable, once-a-day treatments may suffice.  No more than 20 treatments pre-graft and additional 20 treatments post-graft should be needed.

Thermal burns-Burns must be deep second degree or third degree in nature.

Treatment is begun as soon as possible after injury, often during initial resuscitation.  Three treatments should be done within the first 24 hours and twice daily afterwards. In burns of 40% or greater, treatment is rendered for 10-14 days.  Many partial thickness burns will heal without surgery during this time frame and obviate the need for grafting.  Treatment beyond 20-30 sessions is usually utilized to ensure graft take.  While there is no absolute limit to the number of HBO2 treatments, rarely would more than 50 treatments be needed.

Prevention of osteoradionecrosis in patients with head and neck cancer receiving periodontal dental care.

No more than 30 treatments prior to extraction and no more than 10 treatments after extraction.

Hyperbaric oxygen therapy is considered investigational when performed for diagnoses including but not limited to any of the following:

  • Acute arterial peripheral insufficiency
  • Acute cerebral edema
  • Acute coronary syndromes and as an adjunct to coronary interventions, including but not limited to, percutaneous coronary interventions and cardiopulmonary bypass
  • Acute ischemic stroke
  • Acute osteomyelitis
  • Acute surgical and traumatic wounds not meeting criteria specified in the medically necessary statement
  • Amyotrophic lateral sclerosis
  • Anoxic brain injury
  • Autism spectrum disorders
  • Bell’s palsy
  • Bisphosphonate-related osteonecrosis of the jaw
  • Bone grafts
  • Carbon tetrachloride poisoning, acute
  • Cerebral palsy
  • Cerebrovascular disease, acute (thrombotic or embolic) or chronic
  • Chronic arm lymphedema following radiotherapy for cancer
  • Chronic wounds, other than those in patients who meet the criteria specified in the medically necessary statement, including but not limited to pressure ulcers
  • Crohn’s disease
  • Delayed onset muscle soreness
  • Early treatment (beginning at completion of radiation therapy) to reduce side effects of radiation therapy
  • Femoral neck necrosis, idiopathic
  • Fibromyalgia
  • Fracture healing
  • Herpes zoster
  • Hydrogen sulfide poisoning
  • Idiopathic sudden sensorineural hearing loss (ISSNHL)
  • In vitro fertilization
  • Leprosy
  • Meningitis
  • Mental illness (i.e., posttraumatic stress disorder, generalized anxiety disorder or depression)
  • Multiple sclerosis 
  • Migraine headaches 
  • Motor dysfunction associated with stroke
  • Poisoning
  • Pseudomembraneuse colitis
  • Pyoderma gangrenosum
  • Radiation-induced injury in the head and neck
  • Radiation myelitis
  • Refractory mycoses:  mucormycosis, actinomycosis, Conidiobolus coronata
  • Retinal artery insufficiency
  • Retinopathy, adjunct to scleral buckling
  • Sickle cell crisis and/or hematuria
  • Spinal cord injury
  • Traumatic brain injury
  • Tumor sensitization for cancer treatments, including but not limited to, radiotherapy or chemotherapy
  • Ulcerative colitis
  • Vascular dementia

Contraindications to HBO2

Relative Contraindications—these conditions may place patients at higher risk during HBO2 therapy:

Upper respiratory infection

Can preclude clearing of the eustachian tubes and equalizing of internal and external pressure.  Tympanostomy pressure-equalizer (PE) tubes may be inserted or myringotomy performed prior to initiation of HBO2

Otitis Media is a relative contraindication unless PE tubes have been inserted

 

Hypertension

HBO2 therapy causes vasoconstriction and can result in hypertensive crisis unless well controlled by medication

Graves’ disease or any thyroid disorder being treated with thyroid hormone

These disorders increase the metabolic, which in conjunction with HBO2 therapy may cause oxygen toxicity.  An adjustment in the dosage may be necessary

Seizure disorders

HBO2 can disrupt the hemoglobin-oxygen buffering mechanism by which oxidizing free radicals are removed from tissue.  This can result in the oxidation of polyunsaturated fatty acids that are normally present in cells.  Because the central nervous system has high lipid content, it is highly vulnerable.  The resulting CNS oxygen toxicity lowers the seizure threshold in patients with seizure disorders.

Diabetes Mellitus Types 1 and 2

HBO2 has been shown to lower blood glucose levels.

Menstruation

There is a great risk for decompression illness in the early phase of the menstrual cycle.

Eye pathology

Any optic nerve or retinal disorder necessitates an evaluation by an ophthalmologist.

Pregnancy

There is a small risk to the fetus that high oxygen levels will stimulate the muscles around the ductus arteriosus to contract, closing it and causing fetal death.  Treatments should last no longer than 120 minutes.

Infants

In premature infants, high oxygen levels can be toxic to the eye vasculature and can worsen bronchopulmonary dysplasia.  Retrolental fibroplasia is a prominent risk factor in neonates

 

Absolute Contraindications---these conditions absolutely contraindicate the administration of HBO2:

  • Some types of congenital heart disease.  Any cardiac anomaly that results in restriction of right ventricular outflow to the lungs might require the ductus arteriosus to remain patent for the patients to survive. HBO2 promotes the closure of the ductus arteriosus.
  • Obstructed airway or restrictive airway disease can cause local trapping of air during HBO2 decompression.  The expanding gas can lead to alveolar rupture.  In patients with emphysema with carbon dioxide retention, the retention of CO2 also causes respiratory acidosis and cerebral edema, which can lead to respiratory depression, hypoxia, and death. 
  • Recent thoracic surgery if the patient does not have a chest tube. Air trapped in the thorax can expand during HBO2 and result in pneumothorax.
  • Untreated pneumothorax can become a tension pneumothorax during HBO2.
  • Unstable seizure disorders.  If a patient has a seizure inside a monoplace chamber, immediate care cannot be provided.  Unstable seizure disorder is not an absolute contraindication in a multiplace chamber.
  • Pregnancy.  Treatments of longer than 120 minutes are an absolute contraindication (see above).
  • Infancy.  If the infant has a congenital heart defect dependent on a patent ductus arterious for survival.

DESCRIPTION OF PROCEDURE OR SERVICE:

Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen at pressures between 1.5 and 3.0 atmospheres. It is generally applied systemically with the patient inside a hyperbaric chamber. HBOT can also be applied topically; ie, the body part to be treated is isolated (eg, in an inflatable bag and exposed to pure oxygen). HBOT has been investigated for various conditions that have potential to respond to increased oxygen delivery to tissue.

Hyperbaric oxygen therapy (HBOT is a technique for delivering higher pressures of oxygen to tissue. Two methods of administration are available: topical and systemic.

Topical HBOT

Topical hyperbaric oxygen therapy is a technique of delivering 100% oxygen directly to an open, moist wound at a pressure slightly higher than atmospheric pressure. It is hypothesized that the high concentrations of oxygen diffuse directly into the wound to increase the local cellular oxygen tension, which in turn promotes wound healing. Topical hyperbaric oxygen devices consist of an appliance to enclose the wound area (frequently an extremity) and a source of oxygen; conventional oxygen tanks may be used. The appliances may be disposable and may be used without supervision in the home by well-trained patients. Topical hyperbaric oxygen therapy has been investigated as a treatment of skin ulcerations resulting from diabetes, venous stasis, postsurgical infection, gangrenous lesion, decubitus ulcers, amputations, skin graft, burns, or frostbite.

Systemic HBOT

In systemic or large chamber hyperbaric oxygen, the patient is entirely enclosed in a pressure chamber and breathes oxygen at a pressure greater than one atmosphere (atm, the pressure of oxygen at sea level). Thus, this technique relies on systemic circulation to deliver highly oxygenated blood to the target site, typically a wound. In addition, systemic hyperbaric oxygen therapy can be used to treat systemic illness, such as air or gas embolism, carbon monoxide poisoning, or clostridial gas gangrene. Treatment may be carried out either in a monoplace chamber pressurized with pure oxygen or in a larger, multiplace chamber pressurized with compressed air, in which case the patient receives pure oxygen by mask, head tent, or endotracheal tube.

Adverse Events

HBOT is a generally safe therapy, with an estimated adverse side effect rate of 0.4%. Adverse events may occur either from pressure effects or the oxygen. The pressure effect (barotrauma) may affect any closed air-filled cavity such as ears, sinus, teeth, and lungs. Pain and/or swelling may occur at these sites as pressure increases during the procedure, and decreases as the procedure is ending. Oxygen toxicity may affect the pulmonary, neurologic, or ophthalmologic systems. Pulmonary symptoms include a mild cough, substernal burning, and dyspnea. Neurologic effects include tunnel vision, tinnitus, nausea, and dizziness. Ophthalmologic effects include retinopathy in neonates, cataract formation, and transient myopic vision changes.

Note that this evidence review does not address topical oxygen therapy in the absence of pressurization.

KEY POINTS:

The most recent literature review is through April 28, 2023.

Summary of Evidence

For individuals with wounds, burns or infections who receive topical  hyperbaric oxygen therapy (HBOT), the evidence includes a systematic review, case series, and a randomized controlled trial (RCT). Relevant outcomes are overall survival (OS), symptoms, change in disease status, and functional outcomes. The systematic review identified 3 RCTs including patients with sacral pressure ulcers, ischial pressure ulcers, and refractory venous ulcers. All trials reported that healing improved significantly after HBOT than after standard of care. Pooling of results was not possible due to heterogeneity in patient populations and treatment regimens. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with chronic diabetic ulcers who receive systemic HBOT, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms and change in disease status. Meta-analyses of RCTs found significantly higher diabetic ulcer healing rates with HBOT than with control conditions. Two of the 3 meta-analyses found that HBOT was associated with a significantly lower rate of major amputation. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with carbon monoxide poisoning who receive systemic HBOT, the evidence includes RCTs and a systematic review. Relevant outcomes are OS and symptoms. A meta-analysis in a Cochrane review of low-quality RCT data did not find HBOT to be associated with a significantly lower risk of neurologic deficits after carbon monoxide poisoning. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with radionecrosis, osteoradionecrosis, or treatment of irradiated jaw who receive systemic HBOT, the evidence includes RCTs and a systematic review. Relevant outcomes are symptoms and change in disease status. A meta-analysis in a Cochrane review of RCTs found evidence that HBOT improved radionecrosis and osteoradionecrosis outcomes and resulted in better outcomes before tooth extraction in an irradiated jaw. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with chronic refractory osteomyelitis who receive systemic HBOT, the evidence includes case series. Relevant outcomes are symptoms and change in disease status. The case series reported high rates of successful outcomes (no drainage, pain, tenderness, or cellulitis) in patients with chronic refractory osteomyelitis treated with HBOT. However, controlled studies are needed to determine conclusively the impact of HBOT on health outcomes compared with other interventions. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with acute thermal burns who receive systemic HBOT, the evidence includes a systematic review of 2 RCTs. Relevant outcomes are OS, symptoms, and change in disease status. Both RCTs were judged to have poor methodologic quality. Evidence from well-conducted controlled trials is needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with acute surgical and traumatic wounds who receive systemic HBOT, the evidence includes RCTs, controlled nonrandomized studies, and systematic reviews. Relevant outcomes are OS, symptoms, change in disease status, and functional outcomes. There was considerable heterogeneity across the 4 RCTs identified (eg, patient population, comparison group, treatment regimen, outcomes). This heterogeneity prevented pooling of trial findings and limits the ability to definitively conclude the impact of HBOT on health outcomes for patients with acute surgical and traumatic wounds. Additional evidence from high-quality RCTs is needed. A systematic review of controlled Chinese studies suggests HBOT may increase the survival rate of compromised skin grafts and flaps when initiated within 72 hours; however, risk of bias in the original Chinese publications cannot be evaluated. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with bisphosphonate-related osteonecrosis of the jaw who receive systemic HBOT, the evidence includes an RCT. Relevant outcomes are symptoms and change in disease status. The RCT was unblinded and reported initial benefits at 3-month follow-up; however, there were no significant benefits of HBOT for most health outcomes compared with standard care in the long-term (6 months to 2 years).The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with necrotizing soft tissue infections who receive systemic HBOT, the evidence includes systematic reviews. Relevant outcomes are OS, symptoms, and change in disease status. A Cochrane review did not identify any RCTs. Another systematic review of retrospective cohort studies with methodological limitations did not find consistent benefit of adjunctive HBOT use. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with acute coronary syndrome who receive systemic HBOT, the evidence includes RCTs and a systematic review. Relevant outcomes are OS, symptoms, change in disease status, and functional outcomes. A Cochrane review identified 6 RCTs. There were 2 pooled analyses, 1 found significantly lower rates of death with HBOT and the other reported inconsistent results in left ventricular function. Additional RCT data are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with acute ischemic stroke who receive systemic HBOT, the evidence includes RCTs and a systematic review. Relevant outcomes are OS, symptoms, change in disease status, and functional outcomes. Cochrane reviewers could only pool data for a single outcome (mortality at 3 to 6 months), and for that outcome, there was no significant difference between active and sham HBOT treatments. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with motor dysfunction associated with stroke who receive systemic HBOT, the evidence includes an RCT. Relevant outcomes are symptoms and functional outcomes. The RCT, which used a crossover design, found better outcomes with HBOT at 2 months than with delayed treatment. However, the trial had a number of methodologic limitations (eg, lack of patient blinding, heterogeneous population, high dropout rate) that make it difficult to evaluate the efficacy of HBOT. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with Bell palsy who receive systemic HBOT, the evidence includes a systematic review. Relevant outcomes are symptoms, change in disease status, and functional outcomes. A Cochrane review did not identify any RCTs meeting selection criteria; the single RCT found did not have a blinded outcome assessment. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with traumatic brain injury who receive systemic HBOT, the evidence includes RCTs and systematic reviews. Relevant outcomes are OS, symptoms, change in disease status, and functional outcomes. RCTs were heterogeneous regarding intervention protocols, patient populations, and outcomes reported. Systematic reviews conducted pooled analyses only on a minority of the published RCTs, and these findings were inconsistent. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with inflammatory bowel disease who receive systemic HBOT, the evidence includes a RCTs, observational studies, and a systematic review. Relevant outcomes are symptoms, change in disease status and functional outcomes. Three RCTs have reported mixed findings in patients with ulcerative colitis, with one study terminated early due to futility. A systematic review including the RCT and observational studies found a high rate of bias in the literature due to attrition and reporting bias. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with idiopathic sudden sensorineural hearing loss who receive systemic HBOT, the evidence includes systematic reviews. Relevant outcomes are symptoms, change in disease status, and functional outcomes. A Cochrane review of RCTs had mixed findings from studies that included individuals with tinnitus. Some outcomes (ie, improvement in hearing of all frequencies, >25% return of hearing) were better with HBOT than with a control intervention, but more than 50% return of hearing did not differ significantly between groups. There was important variability in the patients enrolled in the studies. A subsequent systematic review had similarly limited conclusions due to the inclusion of non-randomized studies. A third review found a higher proportion of patients with hearing recovery with HBOT compared to medical treatment alone, but the analysis was limited to 2 RCTs with methodological limitations. One RCT published subsequent to the systematic reviews found a positive effect of HBOT plus steroid combination therapy on measures of auditory function compared to either HBOT or steroids alone, but other outcomes were not reported and the study had numerous relevance, design, and conduct limitations. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with delayed-onset muscle soreness who receive systemic HBOT, the evidence includes RCTs and a systematic review. Relevant outcomes are symptoms and functional outcomes. A Cochrane review of RCTs found worse short-term pain outcomes with HBOT than with control and no difference in longer-term pain or other outcomes (eg, swelling). The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with autism spectrum disorder who receive systemic HBOT, the evidence includes an RCT and a systematic review. Relevant outcomes are symptoms and functional outcomes. A Cochrane review identified a single RCT on HBOT for autism spectrum disorder and this trial did not find significantly better parental-assessed or clinician-assessed outcomes with HBOT compared with sham. A subsequent controlled trial reached the same conclusion. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with cerebral palsy who receive systemic HBOT, the evidence includes 2 RCTs and an observational study. Relevant outcomes are symptoms and functional outcomes. One RCT was stopped early due to futility, and the other did not find significantly better outcomes with HBOT than with a sham intervention. The observational study focused on sleep disorders in children with cerebral palsy and reported improvements with the HBOT treatment. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with vascular dementia who receive systemic HBOT, the evidence includes an RCT and a systematic review. Relevant outcomes are symptoms and functional outcomes. The Cochrane review identified only a single RCT with methodologic limitations. Well-conducted controlled trials are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with radiotherapy adverse events who receive systemic HBOT, the evidence includes RCTs, nonrandomized comparator trials, case series, and systematic reviews. Relevant outcomes are symptoms and functional outcomes. Two systematic reviews included few RCTs and provide limited evidence on the effect of HBOT. Two RCTs had inconsistent findings. One reported no short-term benefit with HBOT, but some benefits 12 months after radiotherapy; the other did not find a significant benefit of HBOT at 12-month follow-up. Another RCT assessed HBOT for radiation-induced cystitis and found significant benefit by some measures but not others. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with idiopathic femoral neck necrosis who receive systemic HBOT, the evidence includes an RCT. Relevant outcomes are symptoms, change in disease status, and functional outcomes. The RCT, which had a small sample, only reported short-term (ie, 6-week) outcomes. Larger well-conducted RCTs reporting longer-term outcomes are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with a migraine who receive systemic HBOT, the evidence includes RCTs and a systematic review. Relevant outcomes are symptoms, change in disease status, and functional outcomes. The Cochrane review conducted a pooled analysis including 3 of the 11 trials. Meta-analysis of these 3 RCTs found significantly greater relief of migraine symptoms with HBOT than with a comparator intervention within 45 minutes of treatment. Longer-term data are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with herpes zoster who receive systemic HBOT, the evidence includes an RCT. Relevant outcomes are symptoms and change in disease status. The RCT was unblinded and only reported short-term (ie, 6-week) outcomes. Additional well-conducted RCTs with longer follow-up are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with fibromyalgia who receive systemic HBOT, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status, and functional outcomes. Only 2 RCTs were identified, and both reported positive effects of HBOT on tender points and pain. However, the trials had relatively small samples and methodologic limitations (eg, quasi-randomization, no or uncertain sham control for a condition with subjective outcomes susceptible to a placebo effect). Moreover, the HBOT protocols varied. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with multiple sclerosis who receive systemic HBOT, the evidence includes RCTs and a systematic review. Relevant outcomes are symptoms and functional outcomes. A Cochrane review of RCTs did not find a significant difference in Expanded Disability Status Scale scores when patients with multiple sclerosis were treated with HBOT versus a comparator intervention. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with cancer and are undergoing chemotherapy who receive systemic HBOT, the evidence includes an RCT and a systematic review. Relevant outcomes are OS and change in disease status. While the systematic review reported improvements in tumor control in patients with head and neck cancer who received HBOT, the adverse events accompanying the treatment (eg, radiation tissue injury, seizures) were significant. The single RCT did not find a significant difference in survival for cancer patients who received HBOT before chemotherapy compared with usual care. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

Society of Vascular Surgery et al

In 2016, the Society of Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine published guidelines on the management of the diabetic foot. According to the guidelines, for diabetic foot ulcers that fail to demonstrate improvement (>50% wound area reduction) after a minimum of 4 weeks of standard wound therapy, adjunctive therapy such as HBOT is recommended (grade 1B). Also, for diabetic foot ulcers with adequate perfusion that fail to respond to 4 to 6 weeks of conservative management, HBOT is suggested (grade 2B).

Undersea and Hyperbaric Medical Society

In 2015, the Undersea and Hyperbaric Medical Society (UHMS) published a guideline on use of HBOT for treating diabetic foot ulcers.  This guideline is scheduled for a revision in 2018.  Recommendations are:

  • Suggest against using HBOT in patients with “Wagner Grade 2 or lower diabetic foot ulcers….”
  • Suggest adding HBOT in patients with “Wagner Grade 3 or higher diabetic foot ulcers that have now shown significant improvement after 30 days of [standard of care] therapy….”
  • Suggest “adding acute post-operative hyperbaric oxygen therapy to the standard of care” in patients with “Wagner Grade 3 or higher diabetic foot ulcers” who have just had foot surgery related to their diabetic ulcers.

The 2019 UHMS Hyperbaric Oxygen Therapy Indications (14th edition) included the following indications as recommended:

  • Air or gas embolism
  • Carbon monoxide poisoning and carbon monoxide complicated by cyanide poisoning
  • Clostridial myositis and 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
  • Acute thermal burn injury
  • Sudden sensorineural hearing loss

American Academy of Otolaryngology-Head and Neck Surgery

In 2019, the American Academy of Otolaryngology-Head and Neck Surgery updated clinical guidelines on the treatment of sudden sensorineural hearing loss (SSNHL). They give the following options regarding HBOT:

  • “Clinicians may offer, or refer to a physician who can offer, hyperbaric oxygen therapy (HBOT) combined with steroid therapy within 2 weeks of onset of SSNH.”
  • “Clinicians may offer, or refer to a physician who can offer, hyperbaric oxygen therapy (HBOT) combined with steroid therapy as salvage within 1 months of onset of SSNHL.”

The guideline provided a comprehensive list of evidence gaps and future research needs on the use of HBOT for SSNHL. These included, among others, the need for a standardized, evidence-based definition of SSNHL, the assessment of the prevalence of SSNHL, and the need for the development of standardized HBOT treatment protocols and standardized outcome assessments.

U.S. Preventive Services Task Force Recommendations

HBOT is not a preventive service.

KEY WORDS:

Systemic hyperbaric oxygen, topical hyperbaric oxygen, hyperbaric oxygen, HBO, HBO2, THBO

APPROVED BY GOVERNING BODIES:

In 2013, FDA published a statement warning that non-FDA approved uses of HBOT may endanger the health of patients. If patients mistakenly believe that HBOT devices have been proven safe for uses not cleared by FDA, they may delay or forgo proven medical therapies.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts:  Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING:

CPT: 

99183             

Physician or other qualified health care professional attendance and supervision of hyperbaric oxygen therapy, per session

              

HCPCS:

A4575            

Topical hyperbaric oxygen chamber, disposable

E0446            

Topical oxygen delivery system, not otherwise specified, includes all supplies and accessories.

G0277            

Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval

ICD-10-CM:

Air or gas embolism

T79.0XXA                 Air embolism (traumatic), initial encounter

T80.0XXA                 Air embolism following infusion, transfusion & injection

Carbon monoxide poisoning

T58.01XA-T58.94XA

Cyanide poisoning, acute

T65.0X1A-T65.0X4A

Central retinal artery occlusion

H34.10-H34.13

Clostridial myositis and myonecrosis

A48.0                          Gas gangrene

Compartment Syndromes

T79.A0XA-T79.9XXA

Crush injuries

S07.0XXA-S07.9XXA

S17.0XXA-S17.9XXA

S28.0XXA

S38.001A-S38.1XXA

S47.1XXA-S47.9XXA

S57.00XA-S57.82XA

S67.00XA-S67.92XA

S77.00XA-S77.22XA

S87.00XA-S87.82XA

S97.00XA-S97.82XA

Decompression sickness

T70.3XXA

Delayed radiation injury (soft tissue and bony necrosis)

E32.8                          Other specified diseases of thymus gland

G46.3-G46.8               Vascular syndromes of brain in cerebrovascular disease

G95.11-G95.15          Vascular myelopathies

H74.321-H74.329       Partial loss or necrosis of ear ossicles

I67.89                          Other cerebrovascular disease

I68.0                            Cerebral amyloid angiopathy

I68.8                            Other cerebrovascular disorders in diseases classified elsewhere

J34.81                         Nasal mucositis (ulcerative)

J39.3                           Upper respiratory tract hypersensitivity reaction, site unspecified

J98.09                         Other diseases of bronchus

K02.9                          Other Dental Caries

K04.1                          Necrosis of the Pulp

K51.20-K51.219        Ulcerative Proctitis

K52.0                          Gastroenteritis and Colitis Due to Radiation

K55.0                          Acute Vascular disorder of Intestine (deleted 09/30/2016)

K55.011                      Focal (segmental) acute (reversible) ischemia of small intestine (effective 10/1/2016)

K55.012                      Diffuse acute (reversible) ischemia of small intestine (effective 10/1/2016)

K55.019                      Acute (reversible) ischemia of small intestine (effective 10/1/2016)

K55.021                      Focal (segmental) acute infarction of small intestine  (effective 10/1/2016)

K55.022                      Diffuse acute infarction of small intestine (effective 10/1/2016)

K55.029                      Acute infarction of small intestine, extent unspecified (effective 10/1/2016)

K55.031                      Focal (segmental) acute (reversible) ischemia of large intestine (effective 10/1/2016)

K55.032                      Diffuse acute (reversible) ischemia of large intestine (effective 10/1/2016)

K55.039                      Acute (reversible) ischemia of large intestine, extent unspecified (effective 10/1/2016)

K55.041                      Focal (segmental) acute infarction of large intestine (effective 10/1/2016)

K55.042                      Diffuse acute infarction of large intestine (effective 10/1/2016)

K55.049                      Acute infarction of large intestine, extent unspecified (effective 10/1/2016)

K55.051                      Focal (segmental) acute (reversible) ischemia of intestine, part unspecified (effective 10/1/2016)

K55.052                      Diffuse acute (reversible) ischemia of intestine, part unspecified (effective 10/1/2016)

K55.059                      Acute (reversible) ischemia of intestine, part and extent unspecified (effective 10/1/2016)

K55.061                      Focal (segmental) acute infarction of intestine, part unspecified (effective 10/1/2016)

K55.062                      Diffuse acute infarction of intestine, part unspecified (effective 10/1/2016)

K55.069                      Acute infarction of intestine, part and extent unspecified (effective 10/1/2016)

K63.4                          Enteroptosis

K63.89                        Other Specified Diseases of Intestines

K65.8                          Other peritonitis

K86.1                          Other chronic pancreatitis

K86.8                          Other Specified Diseases of Pancreas (deleted 09/30/2016)

K868.1                        Exocrine pancreatic insufficiency (effective 10/1/2016)

K868.9                        Other specified diseases of pancreas (effective 10/1/2016)

K87                             Disorders of gallbladder, biliary tract and pancreas

K92.89                        Other specified diseases of the digestive system

L59.9                          Disorder of the skin and subcutaneous tissue related to radiation

M27.2                         Inflammatory Conditions of Jaw

M27.8                         Other Specified Diseases of the Jaws

M86.38                       Chronic multifocal osteomyelitis, other site

M86.48                       Chronic osteomyelitis with draining sinus, other site

M86.58                       Other chronic hematogenous osteomyelitis, other site

M86.68                       Other chronic osteomyelitis, other site

M86.8X8                    Other osteomyelitis, other site

N30.40-N30.41           Irradiation Cystitis

N33                             Bladder disorder in diseases classified elsewhere

N64.1                          Fat Necrosis of Breast

N89.8                          Other Specified Noninflammatory Disorders of Vagina

T66.XXXA                Radiation sickness, unspecified, initial encounter

Enhancement of healing in problem/refractory wounds

E08.51-E08.59           Diabetic wounds

E08.618-E08.638       Diabetic wounds

E08.649-E08.8           Diabetic wounds

E09.51-E09.59           Diabetic wounds

E09.618-E09.638       Diabetic wounds

E09.649-E09.8           Diabetic wounds

E10.51-E10.59           Diabetic wounds

E11.51-E11.59           Diabetic wounds

E13.51-E13.59           Diabetic wounds

E13.618                      Diabetic wounds

E13.628-E13.638       Diabetic wounds

E13.649                      Diabetic wounds

I70.231-I70.25            Atherosclerosis with ulcers

I70.331-I70.35            Atherosclerosis with ulcers

I70.431-I70.45            Atherosclerosis with ulcers

I70.531-I70.55            Atherosclerosis with ulcers

I70.631-I70.65            Atherosclerosis with ulcers

I70.731-I70.75            Atherosclerosis with ulcers

I74.2-I74.4                 Arterial insufficiency ulcers

I77.2                            Rupture of Artery

I83.001-I83.029          Varicose Veins of Lower Extremities / With Ulcer

I83.201-I83.229          Varicose Veins of Lower Ext / With Ulcer & inflammation

L89.000-L89.95         Decubitus Ulcers

L97.101-L97.929       Non-pressure chronic ulcers

L98.411-L98.499       Chronic Ulcer

Exceptional blood loss anemia

D62-D63.8

D64.4-D64.9

Intracranial abscess

G06.0

Necrotizing soft tissue infections

A48.0                          Gas gangrene

E08.52                        Gangrene

E09.52                        Gangrene

E10.52                        Gangrene

E11.52                        Gangrene

E13.52                        Gangrene

I70.361-I70.369          Gangrene

I70.461-I70.469          Gangrene

I70.561-I70.569          Gangrene

I70.661-I70.669          Gangrene

I70.761-I70.769          Gangrene

I73.01                          Gangrene

I96                               Gangrene

J02.0                           Streptococcal pharyngitis

J03.00-J03.01             Streptococcal tonsillitis

L44.8-L45                  Other specified disorders of skin

L92.1                          Necrobiosis lipoidica

L94.2                          Calcinosis cutis

L94.4                          Grottron’s papules

L98.8                          Other specified disorders of skin and subcutaneous tissue

L99                             Other disorder of skin and subcutaneous tissue

M72.6                         Necrotizing fasciitis

Osteoradionecrosis

M27.8                        Other Specified Diseases of the Jaws

Other acute traumatic peripheral ischemias (ATPI)

I87.001-I87.9              Other disorders of vein

I99.8-I99.9                  Other or unspecified disorder of circulatory system

R58                             Hemorrhage, Unspecified

Refractory osteomyelitis

A02.24                        Salmonella Osteomyelitis

A18.01                        Tuberculosis of spine

A18.03                        Tuberculosis other specified bone

A50.01-A50.09           Early Congenital Syphilis, Symptomatic

A52.77                        Syphilis of Bone

E08.51-E08.59           Diabetes mellitus with circulatory/skin disorder

E08.618-E08.638       Diabetes mellitus with circulatory/skin disorder

E08.649-E08.8           Diabetes mellitus with circulatory/skin disorder

E09.51-E09.59           Diabetes mellitus with circulatory/skin disorder

E09.618-E09.638       Diabetes mellitus with circulatory/skin disorder

E09.649-E09.8           Diabetes mellitus with circulatory/skin disorder

E10.618-E10.638       Diabetes mellitus with circulatory/skin disorder

E10.649-E10.69         Diabetes mellitus with circulatory/skin disorder

E11.618-E11.638       Diabetes mellitus with circulatory/skin disorder

E11.649-E11.69         Diabetes mellitus with circulatory/skin disorder

E13.51-E13.59           Diabetes mellitus with circulatory/skin disorder

E13.618-E13.638       Diabetes mellitus with circulatory/skin disorder

E13.649-E13.69         Diabetes mellitus with circulatory/skin disorder

H05.021-H05.029       Osteomyelitis

H70.201-H70.209       Petrositis

M27.2                         Inflammatory condition

M46.20-M46.39         Osteomyelitis

M86.30-M86.9           Chronic Osteomyelitis

M89.60-M89.69         Osteopathy after poliomyelitis

M90.80-M90.89         Osteopathy

Thermal Burns

T20.30XA-T20.39XA

T20.70XA-T20.79XA

T21.30XA-T21.39XA

T21.70XA-T21.79XA

T22.30XA-T22.399A

T22.70XA-T22.799A

T23.301A-T23.399A

T23.701A-T23.799A

T24.301A-T24.399A

T24.701A-T24.799A

T25.311A-T25.399A

T25.711A-T25.799A

T26.20XA-T26.22XA

T26.40XA-T26.42XA

T27.0XXA-T28.99XA

T30.0-T32.99

REFERENCES:

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POLICY HISTORY:

Medical Policy Group, December 1994

TEC Assessment, 1999

Medical Policy Group, December 1999

Medical Policy Group, December 2000

Medical Policy Group, September 2001

Medical Policy Review Committee (Topical Hyperbaric Oxygen), June 2002 (2)

Available for comment, August 12-September 27, 2002

Medical Policy Group, October 2003 (2)

Medical Policy Administration Committee, October 2003

Available for comment October 20-December 3, 2003

Medical Policy Group, November 2005 (1)

Medical Policy Group, March 2006 (2)

Medical Policy Administration Committee, March 2006

Available for comments March 14-April 27, 2006

Medical Policy Group, February 2007 (2)

Medical Policy Administration Committee, March 2007

Medical Policy Group, September 2007 (2)

Medical Policy Administration Committee, September 2007

Medical Policy Panel, February 2010

Medical Policy Group, March 2010 (2)

Medical Policy Administration Committee, April 2010

Available for comment April 7-May 21, 2010

Medical Policy Group, December 2010:  2011 Code update

Medical Policy Group, December 2012 (3):  2013 Code updates: Verbiage change to Code 99183.

Medical Policy Panel, August 2013

Medical Policy Group, June 2014 (3):  Updates to Key Points & References; added multiple conditions to investigational listing in Policy section; removed ICD-9 coding from conditions listed throughout Policy section conditions and updated information related to initiation of HBO for retinal artery occlusion within 24 hours  under Policy section

Medical Policy Administration Committee, June 2014

Available for comment June 18 through August 3, 2014

Medical Policy Group, August 2014 (5):  Added ICD-9 and ICD-10-CM diagnosis under Coding; no change to policy statement.

Medical Policy Panel, August 2014

Medical Policy Group, September 2014 (3):  2014 Updates to Key Points, Governing Bodies & References; added ulcerative colitis to investigational list in policy section

Medical Policy Group, November 2014: 2015 Annual Coding update; added G0277 to current coding for HCPCS.

Medical Policy Panel, August 2015

Medical Policy Panel, January 2017

Medical Policy Group, July 2017 (3): 2017 Updates to Description, Key Points, Governing Bodies, & References; removed Previous Coding section for code deleted in 2002; added diagnoses to list considered investigational in Policy section; no change in list considered as meeting medical criteria for coverage

Medical Policy Group, July 2017 (3): ICD10-CM coding section update effective 10/1/16

Medical Policy Panel, January 2018

Medical Policy Group, February 2018 (3): 2018 Updates to Description, Key Points & References; removed policy statements prior to 06/01/14 for central retinal artery occlusion; no changes in current policy statements

Medical Policy Panel, January 2019

Medical Policy Group, March 2019 (7): Updates to Key Points & References; removed ICD-9 coding from Coding Section. No change in Policy Statement.

Medical Policy Panel, January 2020

Medical Policy Group, January 2020 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, January 2021

Medical Policy Group, January 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Group, April 2021 (5): Policy section reformatted and updated to remove “not medically necessary” statements. No change in policy intent.

Medical Policy Group, June 2021 (5): Updates to Policy Statement to clarify definition of sessions allowed per diagnosis. Policy Statement updated to removed “not medically necessary,” no change to policy intent.

Medical Policy Panel, January 2022

Medical Policy Group, January 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, January 2023

Medical Policy Group, January 2023 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, June 2023

Medical Policy Group, June 2023 (5): Updates to Description, Key Points, Benefit Application, and References. Policy Statement updated to clarify the following for investigational use: Acute surgical and traumatic wounds not meeting criteria specified in the medically. No change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.