mp-060
print Print

Hyperbaric Oxygen Therapy

Policy Number: MP-060

Latest Review Date: January 2020

Category: Medical                                                                 

Policy Grade: A

POLICY:

TOPICAL hyperbaric oxygen is considered not medically necessary and investigational.

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

  • Air or gas embolism

No more than 10 sessions should be needed to treat.

  • Carbon monoxide poisoning

Actual treatment pressure and time will vary, but compressions should be between 2.4 and 3.0 atm abs. 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.

  • Clostridial myositis and Myonecrosis (Gas Gangrene)

The recommended treatment profile consists of 100% oxygen at 3.0 atm abs pressure for 90 minutes, 3 times in the first 24 hours and then twice per day for the next 4-5 days. 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, and then BID for 2 days.

  • 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

Actual treatment pressure and time will vary, but compressions should be between 2.4 and 3.0 atm abs. 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 HBO2 treatments are performed at 2.0-2.5 atm abs for 90-120 minutes of oxygen breathing. 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. HBO2 can be administered safely at pressures up to 3 atm abs for 2 to 4 hour periods three or four times daily. 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).

  • Intracranial abscess

HBO2 treatment is administered at a pressure of 2.0 to 2.5 atm abs, with oxygen administration 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)

HBO2 treatments are given at a pressure of 2.0-2.5 atm abs and range from 90 to 120 minutes.  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

Refractory osteomyelitis is chronic osteomyelitis, which has persisted or recurred after appropriate interventions have been performed or where acute osteomyelitis has not responded to accepted management techniques.  The initial treatment depends on the severity of the patient’s clinical disease.  The HBO2 treatments are at a pressure of 2.0-2.5 atm abs and 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. HBO2 treatments are at a pressure of 2.0-2.5 atm abs.  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 given at 2.0-2.5 atm abs of pressure and range 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.  Careful attention to fluid management is mandatory.  Initial requirements may be several liters per hour, and pumps capable of this delivery at pressure must be utilized in the hyperbaric chamber.  Patients can be maintained on ventilator support during HBO2.  Maintenance of a comfortable, ambient temperature must be accomplished.  Treatment within two hours of dressing changes is not recommended, as temperature control may be difficult.  Febrile patients must be closely monitored, as they are more prone to oxygen toxicity.  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.

Studies indicate prophylactic hyperbaric oxygen treatments are beneficial in the prevention of osteoradionecrosis.  No more than 30 treatments prior to extraction and no more than 10 treatments after extraction.

Hyperbaric oxygen therapy is considered not medically necessary and 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
  • 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 (atm). Hyperbaric oxygen therapy is generally applied systemically with the patient inside a hyperbaric chamber. It can also be applied topically; that is, the body part to be treated is isolated (e.g., 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 the tissues.

HBOT is a technique of delivering higher pressures of oxygen to the tissues. Two methods of administration are available.

Systematic 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.

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.

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 November 11, 2019.

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 one randomized controlled trial (RCT). Relevant outcomes are overall survival, symptoms, change in disease status, and functional outcomes. The systematic review identified three 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 single small RCT (N=28) was not included in the review and the uncontrolled studies do not provide sufficient data that topical HBOT is efficacious. The evidence is insufficient to determine the effects of the technology on health outcomes.

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. One of the two 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 a meaningful 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 overall survival 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 the effects of the technology on health outcomes.  However, clinical input obtained in 2010 and guidelines from the Undersea and Hyperbaric Medical Society and the 10th European Consensus Conference on Hyperbaric Medicine support HBOT for the treatment of carbon monoxide poisoning.  Thus, based on clinical input and guideline support, this indication may be considered as meeting medical criteria for coverage.

For individuals who have 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 is a Cochrane review of RCTs found evidence that HBOT improved radionecrosis and osteoradionecrosis outcomes and resulted in better outcomes prior to tooth extraction in an irradiated jaw. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have 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 the effects of the technology on health outcomes. However, clinical input obtained in 2010 and Undersea and Hyperbaric Medical Society guidelines support HBOT for the treatment of chronic refractory osteomyelitis.  Thus, based on clinical input and guideline support, the indication may be considered to meet medical criteria for coverage.

For individuals who have acute thermal burns who receive systemic HBOT, the evidence includes a systematic review of two RCTs. Relevant outcomes are overall survival, symptoms, and change in disease status. Only two RCTs were identified and both were judged to have poor methodologic quality. Evidence from well-conducted controlled trials is needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have acute surgical and traumatic wounds who receive systemic HBOT, the evidence includes RCTs, controlled nonrandomized studies, and systematic reviews. Relevant outcomes are overall survival, symptoms, change in disease status, and functional outcomes. Four RCTs were identified. There was considerable heterogeneity across trials (e.g., patient population, comparison group, treatment regimen, outcomes). This heterogeneity prevented pooling of study findings and limits the ability to draw conclusions about the impact of HBOT on health outcomes for patients with acute surgical and traumatic wounds. Additional evidence from high-quality RCTs is needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have bisphosphonate-related osteonecrosis of the jaw who receive systemic HBOT, the evidence includes one 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 (six months to two years). The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have necrotizing soft tissue infections who receive systemic HBOT, the evidence includes systematic reviews and a retrospective cohort study. Relevant outcomes are overall survival, symptoms, and change in disease status. A Cochrane review did not identify any RCTs. Another systematic review identified a retrospective cohort study, which did not find better outcomes after HBOT than after standard care without HBOT in patients with necrotizing soft tissue infections.

For individuals who have acute coronary syndrome who receive systemic HBOT, the evidence includes RCTs and a systematic review. Relevant outcomes are overall survival, symptoms, change in disease status, and functional outcomes. A Cochrane review identified six RCTs. There were two pooled analyses, one found significantly lower rates of death with HBOT, the other reported inconsistent results in left ventricular function. Additional RCT data are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have acute ischemic stroke who receive systemic HBOT, the evidence includes RCTs and a systematic review. Relevant outcomes are overall survival, symptoms, change in disease status, and functional outcomes. Cochrane reviewers could only pool data for one outcome (mortality at three-six months) and for that outcome there was no significant difference between active and sham HBOT treatments. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have motor dysfunction associated with stroke who receive systemic HBOT, the evidence includes one RCT. Relevant outcomes are symptoms and functional outcomes. The RCT, which used a crossover design, found better outcomes with HBOT at two months than with delayed treatment. However, the trial had a number of methodologic limitations (e.g., lack of patient blinding, heterogeneous population, high dropout rate) that make it difficult to draw conclusions about the efficacy of HBOT. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have 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 the effects of the technology on health outcomes.

For individuals who have traumatic brain injury who receive systemic HBOT, the evidence includes RCTs and systematic reviews. Relevant outcomes are overall survival, symptoms, change in disease status, and functional outcomes. RCTs were heterogenous in terms of intervention protocols, patient populations, and outcomes reported. Multiple RCTs of US military service members showed no statistical difference in outcomes between HBOT groups and those that received sham treatment. Systematic reviews conducted pooled analyses only on a minority of the published RCTs and these findings were mixed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have inflammatory bowel disease who receive systemic HBOT, the evidence includes RCTs, observational studies and a systematic review. Relevant outcomes are symptoms, change in disease status and functional outcomes. Only one small RCT has been published, and this study did not find a significant improvement in health outcomes when HBOT was added to standard medical therapy. A systematic review of RCTs and observational studies found a high rate of bias in the literature due to attrition and reporting bias. The evidence is insufficient to determine the effects of the technology on health 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. One RCT included in this review included patients with idiopathic sudden sensorineural hearing loss and found no differences in HBOT treatment compared with steroid injections in mean hearing thresholds at 0.25, 0.5, 1, and 4 kHz; however, a significant difference was detected at the 2-kHz level. Nonrandomized studies of HBOT used as adjunctive therapy did not support incremental value, although 1 systematic review evaluated HBOT along with steroid therapy and found benefit specifically for those with severe-to-profound idiopathic sudden sensorineural hearing loss. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have 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 a control condition and no difference in longer term pain or other outcomes (e.g., swelling). The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have autism spectrum disorder who receive systemic HBOT, the evidence includes one RCT and a systematic review. Relevant outcomes are symptoms and functional outcomes. A Cochrane review identified one 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 the effects of the technology on health outcomes.

For individuals who have cerebral palsy who receive systemic HBOT, the evidence includes two 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 HBOT. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have vascular dementia who receive systemic HBOT, the evidence includes one RCT and a systematic review. Relevant outcomes are symptoms and functional outcomes. A Cochrane review identified a single RCT. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have radiotherapy adverse effects who receive systemic HBOT, the evidence includes RCTs, nonrandomized comparator trials, case series, and a systematic review. Relevant outcomes are symptoms and functional outcomes. Two systematic reviews were identified, but pooled analyses were not possible due to heterogeneity in treatment regimens and outcomes measured.  One systematic review concluded that more RCTs are needed. The two RCTs identified had inconsistent findings. One found no short-term benefit with HBOT, but some benefits 12 months after radiotherapy; the other RCT 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.An observational study for dry mouth (xerostomia) caused by radiotherapy found some benefit to HBOT. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have idiopathic femoral neck necrosis who receive systemic HBOT, the evidence includes one RCT. Relevant outcomes are symptoms, change in disease status, and functional outcomes. The RCT had a small sample and only reported short-term (i.e., six-week) outcomes. Larger well-conducted RCTs reporting longer term outcomes are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have 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 one pooled analysis, including three of the 11 trials. Meta-analysis of three RCTs found significantly greater relief of migraine symptoms with HBOT than a comparator intervention within 45 minutes of treatment. Longer term data are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have herpes zoster who receive systemic HBOT, the evidence includes one RCT. Relevant outcomes are symptoms and change in disease status. The RCT was unblinded and only reported short-term (i.e., six-week) outcomes. Additional well-conducted RCTs with longer follow-up are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have fibromyalgia who receive systemic HBOT, the evidence includes RCTs. Relevant outcomes are symptoms, change in disease status and functional outcomes. Only two 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 (e.g., 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 the effects of the technology on health outcomes.

For individuals who have 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 the effects of the technology on health outcomes.

For individuals who have cancer and are undergoing chemotherapy who receive systemic HBOT, the evidence includes one RCT and a systematic review. Relevant outcomes are overall survival 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 (e.g., radiation tissue injury, seizures) were significant. The single RCT did not find a significant difference in survival for cancer patients who received HBOT prior to chemotherapy compared with usual care. The evidence is insufficient to determine the effects of the technology on health outcomes.

PRACTICE GUIDELINES AND POSITION STATEMENTS

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.

Infectious Disease Society of America

In 2012, the Infectious Disease Society of America published guidelines on the diagnosis and treatment of diabetic foot infections. The guidelines stated that “for selected diabetic foot wounds that are slow to heal, clinicians might consider using hyperbaric oxygen therapy (strength of evidence: strong; quality of evidence: mode

rate).”

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

Undersea and Hyperbaric Medical Society (UHMS) published indications considered appropriate for hyperbaric oxygen therapy; the latest update was published in 2014 (13th edition).  These indications are as follows:

  • 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
  • Arterial insufficiencies
    • Central retinal artery occlusion
    • Enhancement of healing in selected problem wounds
  • Severe anemia
  • Intracranial abscess
  • Necrotizing soft tissue infections
  • Osteomyelitis (refractory)
  • Delayed radiation injury (soft tissue and bony necrosis)
  • Skin grafts and flaps (compromised)
  • Acute thermal burn injury
  • Idiopathic sudden sensorineural hearing loss (ISSNHL) (patients with moderate to profound ISSNHL who present within 14 days of symptom onset)

UHMS has also published position statements that concluded there was insufficient evidence to recommend topical HBOT for chronic wounds (2005), multiple sclerosis, and autism spectrum disorder (2009).

American Academy of Otolaryngology-Head and Neck Surgery

In 2018, the American Academy of Otolaryngology-Head and Neck Surgery updated a clinical guideline on treatment of sudden hearing loss. 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.

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. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

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:

  1. Alex J, Laden G, Cale AR et al. Pretreatment with hyperbaric oxygen and its effect on neuropsychometric dysfunction and systemic inflammatory response after cardiopulmonary bypass: a prospective randomized double-blind trial. J Thorac Cardiovasc Surg 2005; 130(6):1623-1630.
  2. Almosnino G, Holm JR, Schwartz SR, et al. The Role of Hyperbaric Oxygen as Salvage Therapy for Sudden Sensorineural Hearing Loss. Ann Otol Rhinol Laryngol. Oct 2018;127(10):672-676. 
  3. American Academy of Otolaryngology-Head and Neck Surgery. Clinical practice guideline: sudden hearing loss. Available online at: www.guideline.gov. Accessed December, 2016.
  4. Bennett M, Best TM, Babul S et al. Hyperbaric oxygen therapy for delayed onset muscle soreness and closed soft tissue injury. Cochrane Database Syst Rev 2005; (4):CD004713.
  5. Bennett M, Feldmeier J, Smee R, et al. Hyperbaric oxygenation for tumour sensitisation to radiotherapy. Cochrane Database Syst Rev. 2005(4):CD005007.
  6. Bennett M, Hart B. UHMS Position Paper: The treatment of autism spectrum disorder with hyperbaric oxygen therapy 2009. Available online at: membership.uhms.org/resource/resmgr/position_papers/autism_position_paper.pdf.
  7. Bennett M, Heard R. Hyperbaric oxygen therapy for multiple sclerosis. Cochrane Database Syst Rev. 2004(1):CD003057.
  8. Bennett M., B. H. UHMS Position Paper: the treatment of autism spectrum disorder with hyperbaric oxygen therapy. North Palm Beach, FL: Undersea & Hyperbaric Medical Society (UHMS); 2009.
  9. Bennett M., Heard R. UHMS Position Paper: the treatment of multiple sclerosis with hyperbaric oxygen therapy. North Palm Beach, FL: Undersea & Hyperbaric Medical Society (UHMS); n.d.
  10. Bennett MH, Feldmeier J, Hampson N et al. Hyperbaric oxygen therapy for late radiation tissue injury. Cochrane Database Syst Rev Apr 28, 2016; 4:CD005005.
  11. Bennett MH, French C, Schnabel A et al. Normobaric and hyperbaric oxygen therapy for migraine and cluster headache. Cochrane Database Syst Rev Dec 28 2015; (12):CD005219.
  12. Bennett MH, Kertesz T, Yeung P. Hyperbaric oxygen for idiopathic sudden sensorineural hearing loss and tinnitus. Cochrane Database Syst Rev 2012; (10):CD004739.
  13. Bennett MH, Lehm JP, Jepson N. Hyperbaric oxygen therapy for acute coronary syndrome. Cochrane Database Syst Rev Jul 23 2015; (7):CD004818.
  14. Bennett MH, Stanford RE, Turner R. Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union. Cochrane Database Syst Rev 2012; 11:CD004712.
  15. Bennett MH, Trytko B, Jonker B. Hyperbaric oxygen therapy for the adjunctive treatment of traumatic brain injury. Cochrane Database Syst Rev 2012; 12:CD004609.
  16. Bennett MH, Weibel S, Wasiak J, et al. Hyperbaric oxygen therapy for acute ischaemic stroke. Cochrane Database Syst Rev. 2014; 11:CD004954.
  17. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Hyperbaric oxygen thearpy for wound healing- part I. TEC Assessments 1999; Volume 14(Tab 13).
  18. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Hyperbaric oxygen therapy for wound healing- Part II. TEC Assessments 1999; Volume 14(Tab 15).
  19. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Hyperbaric oxygen therapy for wound healing- Part III. TEC Assessments 1999; Volume 14(Tab 16).
  20. Borab Z, Mirmanesh MD, Gantz M, et al. Systematic review of hyperbaric oxygen therapy for the treatment of radiation-induced skin necrosis. J Plast Reconstr Aesthet Surg. Apr 2017; 70(4):529-538.
  21. Buckley NA, Juurlink DN, Isbister G et al. Hyperbaric oxygen for carbon monoxide poisoning. Cochrane Database Syst Rev 2011; (4):CD002041.
  22. Camporesi EM, Vezzani G, Bosco G et al. Hyperbaric oxygen therapy in femoral head necrosis. J Arthroplasty 2010; 25(6 Suppl):118-123.
  23. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29). 2006; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?ncdid=12&ver=3. Accessed December 10, 2019.
  24. Chandrasekhar SS, Tsai Do BS, Schwartz SR, et al. Clinical practice guidelines: sudden sensorineural hearing loss (update). Otolayngol Head Neck Surg. 2019 Aug;161(1_suppl):S1-S45.
  25. Chen CE, Ko JY, Fu TH et al. Results of chronic osteomyelitis of the femur treated with hyperbaric oxygen: a preliminary report. Chang Gung Med J 2004; 27(2):91-7.
  26. Chen CE, Shih ST, Fu TH et al. Hyperbaric oxygen therapy in the treatment of chronic refractory osteomyelitis: a preliminary report. Chang Gung Med J 2003; 26(2):114-121.
  27. Chen CY, Lee SS, Chan YS et al. Chronic refractory tibia osteomyelitis treated with adjuvent hyperbaric oxygen: a preliminary report. Changgeng Yi Xue Za Zhi 1998; 21(2):165-171.
  28. Churchill S, Deru K, Weaver LK, et al. Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):331-340.
  29. Cifu DX, Walker WC, West SL, et al. Hyperbaric oxygen for blast-realted postconcussion syndrome: three-month outcomes. Ann Neurol. Feb 2014; 75(2):277-286.
  30. Collet J.P., Vanasse M., et al. Hyperbaric oxygen for children with cerebral palsy: a randomized multicentre trial. HBO-CP research Group, Lancet 2001 Feb 24; 357(9256): 582-586.
  31. Crawford C, Teo L, Yang E, et al. Is hyperbaric oxygen therapy effective for traumatic brain injury? a rapid evidence assessment of the literature and recommendations for the field. J Head Trauma Rehabil. May/Jun 2017;32(3):E27-E37.
  32. Cvorovic L, Jovanovic MB, Milutinovic Z, et al. Randomized prospective trial of hyperbaric oxygen therapy and intratympanic steroid injection as salvage treatment of sudden sensorineural hearing loss. Otol Neurotol. Aug 2013; 34(6):1021-1026.
  33. Dauwe PB, Pulikkottil BJ, Lavery L, et al. Does hyperbaric oxygen therapy in facilitating acute wound healing: a systematic review. Plast Reconstr Surg. Feb 2014; 133(2):208e-215e.
  34. Davis JC, Heckman JD, DeLee JC et al. Chronic non-hematogenous osteomyelitis treated with adjuvant hyperbaric oxygen. J Bone Joint Surg Am 1986; 68(8):1210-1217.
  35. de Smet GHJ, Kroese LF, Menon AG, et al. Oxygen therapies and their effects on wound healing. Wound Repair Regen. Aug 2017; 25(4):591-608.
  36. Dulai PS, Gleeson MW, Taylor D, et al. Systematic review: The safety and efficacy of hyperbaric oxygen therapy for inflammatory bowel disease. Aliment Pharmacol Ther. Jun 2014; 39(11):1266-1275.
  37. Effects of hyperbaric oxygenation therapy on adaptive, aberrant and stereotyped behaviors in children with autism. NCT00404846.  Clinical Trails.gov.
  38. Efrati S, Fishlev G, Bechor Y et al. Hyperbaric oxygen induces late neuroplasticity in post stroke patients--randomized, prospective trial. PLoS One 2013; 8(1):e53716.
  39. Efrati S, Golan H, Bechor Y, et al. Hyperbaric oxygen therapy can diminish fibromyalgia syndrome - prospective clinical trial. PLoS One. 2015; 10(5):e0127012.
  40. Elraiyah T, Tsapas A, Prutsky G, et al. A systematic review and meta-analysis of adjunctive therapies in diabetic foot ulcers. J Vasc Surg. Feb 2016; 63(2 Suppl):46S-58S e41-42.
  41. Eryigit B, Ziylan F, Yax F, Thomeer HGXM. The effectiveness of hyperbaric oxygen in patients with idiopathic sudden sensorineural hearing loss: a systematic review. Eur Arch Otorhinolaryngol. 2018 Dec;275(12):28932904.
  42. Eskes A, Ubbink DT, Lubbers M et al. Hyperbaric oxygen therapy for treating acute surgical and traumatic wounds. Cochrane Database Syst Rev 2010; (10):CD008059.
  43. Eskes A, Vermeulen H, Lucas C, et al. Hyperbaric oxygen therapy for treating acute surgical and traumatic wounds.  Cochrane Database Syst Rev. 2013; 12:CD009059.
  44. Esposito M, Grusovin MG, Patel S et al. Interventions for replacing missing teeth: hyperbaric oxygen therapy for irradiated patients who require dental implants. Cochrane Database Syst Rev 2008; (1):CD003603.
  45. Federal Food and Drug Administration. Hyperbaric Oxygen Therapy: Don’t Be Misled. 2013; www.fda.gov/forconsumers/consumerupdates/ucm364687.htm. Accessed December, 2016.
  46. Feldmeier JJ, Hopf HW, Warriner RA, 3rd, et al. UHMS position statement: topical oxygen for chronic wounds. Undersea Hyperb Med. May-Jun 2005; 32(3):157-168.
  47. Freiberger JJ, Padilla-Burgos R, McGraw T et al. What is the role of hyperbaric oxygen in the management of bisphosphonate-related osteonecrosis of the jaw: a randomized controlled trial of hyperbaric oxygen as an adjunct to surgery and antibiotics. J Oral Maxillofac Surg 2012; 70(7):1573-1583.
  48. Friedman HI, Fitzmaurice M, Lefaivre JF et al. An evidence-based appraisal of the use of hyperbaric oxygen on flaps and grafts. Plast Reconstr Surg 2006; 117(7 Suppl):175S-90S; discussion 91S-92S.
  49. George ME, Rueth NM, Skarda DE et al. Hyperbaric oxygen does not improve outcome in patients with necrotizing soft tissue infection. Surg Infect (Larchmt) 2009; 10(1):21-28.
  50. Gesell LB, ED.  Hyperbaric oxygen therapy indications 12th Edition. Undersea and Hyperbaric Medical Society Hyperbaric Oxygen Therapy Committee Report 2008.
  51. Ghanizadeh A. Hyperbaric oxygen therapy for treatment of children with autism: a systematic review of randomized trials. Med Gas Res 2012; 2:13.
  52. Gothard L, Haviland J, Bryson P et al. Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for cancer. Radiother Oncol 2010; 97(1):101-107.
  53. Hampson N.B., chairman and editor. Hyperbaric oxygen therapy: 1999 committee report, Kensington, MD: Undersea and Hyperbaric Medical Society, 1999.
  54. Hart BB, Weaver LK, Gupta A, et al. Hyperbaric oxygen for mTBI-associated PCS and PTSD: pooled analysis of results from Department of Defense and other published studies. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):353383.
  55. Hart BB, Wilson SH, Churchill S, et al. Extended follow-up in a randomized trial of hyperbaric oxygen for persistent post-concussive symptoms. Undersea Hyperb med. 2019 BIMA Special Edition No. Feb;46(3):313-327.
  56. Heng M.C.Y., Pilgrim J.P., and Beck F.W.J.  A simplified hyperbaric oxygen technique for leg ulcers, Arch Dermatol 1984; 120:640-645.
  57. Heng MCY.  Topical hyperbaric therapy for problem skin wounds.  J Dermatol Surg Oncol 1993; 19:784-793.
  58. Heys SD, Smith IC, Ross JA et al. A pilot study with long term follow up of hyperbaric oxygen pretreatment in patients with locally advanced breast cancer undergoing neo-adjuvant chemotherapy. Undersea Hyperb Med 2006; 33(1):33-43.
  59. Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg. Feb 2016; 63(2 Suppl):3S-21S.
  60. Holland NJ, Bernstein JM, Hamilton JW. Hyperbaric oxygen therapy for Bell's palsy. Cochrane Database Syst Rev 2012; 2:CD007288.
  61. Huang ET, Mansouri J, Murad MH, et al. A clinical practice guideline for the use of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers. Undersea Hyperb Med. May-Jun 2015; 42(3):205-247.
  62. Hyperbaric oxygen therapy (HBO2) for persistent post-concussive symptoms after mild traumatic brain injury (mTBI) (HOPPS). U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01306968. Updated September 2014. Accessed December 5, 2019
  63. Hyperbaric Oxygen Therapy Committee of the Undersea and Hyperbaric Medical Society. Indications for Hyperbaric Oxygen Therapy Available online at: membership.uhms.org/?page=Indications.
  64. Hyperbaric Oxygen Therapy for Adults with Mental Illness: A Review of the Clinical Effectiveness. Ottawa ON: 2014 Canadian Agency for Drugs and Technologies in Health; 2014.
  65. Jallali N, Withey S, Butler PE. Hyperbaric oxygen as adjuvant therapy in the management of necrotizing fasciitis. Am J Surg 2005; 189(4):462-466.
  66. Kalliainen LK, Gordillo GM, et al. Topical oxygen as an adjunct to wound healing: a clinical case series. Pathophysiology 2003; 9: 81-87.
  67. Kranke P, Bennett MH, Martyn-St James M et al. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev Jun 24, 2015(6):CD004123.
  68. Lacey DJ, Stolfi A, Pilati LE. Effects of hyperbaric oxygen on motor function in children with cerebral palsy. Ann Neurol 2012; 72(5):695-703.
  69. Landau Z.  Topical hyperbaric oxygen and low energy laser for the treatment of diabetic foot ulcers, Arch Orthop Trauma Surg 1998; 117:156-158.
  70. Leifer G.  Hyperbaric oxygen therapy: pre-and posttreatment nursing responsibilities every staff nurse needs to know about, AJN 2001; 101(8): 26-34.
  71. Leslie C.A., Sapico F.L., et al.  Randomized controlled trial of topical hyperbaric oxygen for treatment of diabetic foot ulcers, Diabetes Care 1988; 11:111-115.
  72. Levett D, Bennett MH, Millar I. Adjunctive hyperbaric oxygen for necrotizing fasciitis. Cochrane Database Syst Rev. 2015; 1:CD007937.
  73. Lewis JD, Chuai S, Nessel L, et al. Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis. Dec 2008; 14(12):1660-1666.
  74. Lipsky BA, Berendt AR, Cornia PB, et al. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. J Am Podiatr Med Assoc. Jan-Feb 2013; 103(1):2-7.
  75. Logue CJ. An inconvenient truth? Ann Emerg Med 2008; 51(3):339-340; author reply 40-42.
  76. Londahl M, Landin-Olsson M, Katzman P. Hyperbaric oxygen therapy improves health-related quality of life in patients with diabetes and chronic foot ulcer. Diabet Med 2011; 28(2):186-190.
  77. Long Y, Tan J, Nie Y, et al. Hyperbaric oxygen therapy is safe and effective for the treatment of sleep disorders in children with cerebral palsy. Neurol Res. Mar 2017; 39(3):239-247.
  78. Marois P, Mukherjee A, Ballaz L. Hyperbaric Oxygen Treatment for Persistent Postconcussion Symptoms-A Placebo Effect? JAMA Intern Med. Jul 1 2015; 175(7):1239-1240.
  79. Marx, Robert E., Johnson, Robert P., Kline, Stuart N. Prevention of osteoradionecrosis: A randomized prospective clinical trial of hyperbaric oxygen versus penicillin, JADA, July 1985, Vol. 111, pp. 49-54.
  80. Mathieu D, Marroni A, Kot J. Tenth European Consensus Conference on Hyperbaric Medicine: recommendations for accepted and non-accepted clinical indications and practice of hyperbaric oxygen treatment. Diving Hyperb Med. Mar 2017; 47(1):24-32.
  81. Maynor ML, Moon RE, Camporesi EM et al. Chronic osteomyelitis of the tibia: treatment with hyperbaric oxygen and autogenous microsurgical muscle transplantation. J South Orthop Assoc 1998; 7(1):43-57.
  82. Mayo Endoscopic Scoring of Ulcerative Colitis. www.sages.co.za/images/MAYO%203.pdf.
  83. Miller RS, Weaver LK, Bahraini N, et al. Effects of hyperbaric oxygen on symptoms and quality of life among service members with persistent postconcussion symptoms: a randomized clinical trial. JAMA Intern Med. Jan 2015; 175(1):43-52.
  84. mTBI mechanisms of action of HBO2 for persistent post-concussive symptoms. U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01611194. Updated November 21, 2018. Accessed December 5, 2019.
  85. Murphy-Lavoie H, Piper S, Moon RE et al. Hyperbaric oxygen therapy for idiopathic sudden sensorineural hearing loss. Undersea Hyperb Med 2012; 39(3):777-792.
  86. O’Reilly D, Pasricha A, Campbell K, et al. Hyperbaric oxygen therapy for diabetic ulcers: systematic review and meta-analysis. Int J Technol Assess Health Care. Jul 2013; 29(3):269-281.
  87. Oscarsson N, Muller B, Rosen A, et al. Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomized, controlled, phase 2-3 trial. Lancet Oncol. 2019 Nov;20(11):1602-1614.
  88. Pagoldh M, Hultgren E, Arnell P, et al. Hyperbaric oxygen therapy does not improve the effects of standardized treatment in a severe attack of ulcerative colitis: a prospective randomized study. Scand J Gastroenterol. Sept 2013; 48(9):1033-1040.
  89. Peng Z, Wang S, Huang X et al. Effect of hyperbaric oxygen therapy on patients with herpes zoster. Undersea Hyperb Med 2012; 39(6):1083-1087.
  90. Ravi P, Vaishnavi D, Gnanam A, et al. The role of hyperbaric oxygen therapy in the prevention and management of radiation-induced complications of the head and neck - a systematic review of literature. J Stomatol Oral Maxillofac Surg. Dec 2017; 118(6):359-362.
  91. Rhee TM, Hwang D, Lee JS, et al. Addition of Hyperbaric Oxygen Therapy vs Medical Therapy Alone for Idiopathic Sudden Sensorineural Hearing Loss: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. Sep 27 2018.
  92. Rizzato A, DAlessandro N, Berenci E, et al. Effect of mild hyperbaric oxygen therapy on children diagnosed with autism. Undersea Hyperb Med. 2018 Nov-Dec;45(6):639-645.
  93. Rossignol DA, Bradstreet JJ, Van Dyke K et al. Hyperbaric oxygen treatment in autism spectrum disorders. Med Gas Res 2012; 2(1):16.
  94. Rossignol DA, Rossignol LW, Smith S et al. Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind controlled trial. BMC Pediatrics 2009; 9:21.
  95. Rusyniak DE, Kirk MA, May JD et al. Hyperbaric oxygen therapy in acute ischemic stroke: results of the Hyperbaric Oxygen in Acute Ischemic Stroke Trial Pilot Study. Stroke 2003; 34(2):571-574.
  96. Sadri RA, Cooper JS. Hyperbaric, complications. NCBI Bookshelf 2017; www.ncbi.nlm.nih.gov/books/NBK459191/. Accessed November 21, 2017.
  97. Sampanthavivat M, Singkhwa W, Chaiyakul T et al. Hyperbaric oxygen in the treatment of childhood autism: a randomised controlled trial. Diving Hyperb Med 2012; 42(3):128-133.
  98. Scheinkestel CD, Bailey M, Myles PS et al. Hyperbaric or normobaric oxygen for acute carbon monoxide poisoning: a randomised controlled clinical trial. Med J Aust 1999; 170(5):203-210.
  99. Sen CK, Khanna S, et al.  Oxidant-induced vascular endothelia growth factor expression in human keratinocytes and cutaneous wound healing.  J of Biolog Chem, 2002; 277(36): 33284-33290.
  100. Shao Y, Lu GL, Shen ZJ. Comparison of intravesical hyaluronic acid instillation and hyperbaric oxygen in the treatment of radiation-induced hemorrhagic cystitis. BJU Int 2012; 109(5):691-694.
  101. Sharifi M, Fares W, Abdel-Karim I et al. Usefulness of hyperbaric oxygen therapy to inhibit restenosis after percutaneous coronary intervention for acute myocardial infarction or unstable angina pectoris. Am J Cardiol 2004; 93(12):1533-1535.
  102. Sherlock S, Way M, Tabah A. Hyperbaric oxygen treatment for the management of radiation-induced xerostomia. J Med Imaging Radiat Oncol. 2018 Dec;62(6):841-846.
  103. Spiegelberg L, Djasim UM, van Neck HW et al. Hyperbaric oxygen therapy in the management of radiation-induced injury in the head and neck region: a review of the literature. J Oral Maxillofac Surg 2010; 68(8):1732-1739.
  104. Steele J, Matos LA, Lopez EA et al. A Phase I safety study of hyperbaric oxygen therapy for amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord 2004; 5(4):250-254.
  105. Sultan A, Hanna GJ, Margalit DN, et al. The use of hyperbaric oxygen for the prevention and management of osteoradionecrosis of the jaw: a Dana-Farber/Brigham and Women's Cancer Center Multidisciplinary Guideline. Oncologist. Mar 2017; 22(3):343-350.
  106. Sun H, Qiu X, Hu J, et al. Comparison of intratympanic dexamethasone therapy and hyperbaric oxygen therapy for the salvage treatment of refractory high-frequency sudden sensorineural hearing loss. Am J Otolaryngol. Sep - Oct 2018;39(5):531-535. 
  107. Suzuki H, Hashida K, Nguyen KH et al. Efficacy of intratympanic steroid administration on idiopathic sudden sensorineural hearing loss in comparison with hyperbaric oxygen therapy. Laryngoscope 2012; 122(5):1154-1157.
  108. Teguh DN, Levendag PC, Noever I et al. Early hyperbaric oxygen therapy for reducing radiotherapy side effects: early results of a randomized trial in oropharyngeal and nasopharyngeal cancer. Int J Radiation Oncol Biol Phys 2009; 75(3):711-716.
  109. Topuz E, Yigit O, Cinar U et al. Should hyperbaric oxygen be added to treatment in idiopathic sudden sensorineural hearing loss? Eur Arch Otorhinolaryngol 2004; 261(7):393-396.
  110. Van Voorhis BJ, Greensmith JE, Dokras A et al. Hyperbaric oxygen and ovarian follicular stimulation for in vitro fertilization: a pilot study. Fertil Steril 2005; 83(1):226-228.
  111. Verrazzo G, Coppola L, Luongo C et al. Hyperbaric oxygen, oxygen-ozone therapy, and rheologic parameters of blood in patients with peripheral occlusive arterial disease. Undersea Hyperb Med 1995; 22(1):17-22.
  112. Villanueva E, Bennett MH, Wasiak J, et al. Hyperbaric oxygen therapy for thermal burns. Cochrane Database Syst Rev. 2004(3):CD004727.
  113. Wang F, Wang Y, Sun T, et al. Hyperbaric oxygen therapy for the treatment of traumatic brain injury: a meta-analysis. Neurol Sci. May 2016; 37(5):693-701.
  114. Weaver LK, Churchill S, Wilson SH, et al. A composite outcome for mild traumatic brain injury in trials of hyperbaric oxygen. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):341-352.
  115. Weaver LK, editor. Hyperbaric Oxygen Therapy Indications. 13th ed. North Palm Beach, FL: Undersea and Hyperbaric Medical Society; 2014.
  116. Weaver LK, Hopkins RO, Chan KJ et al. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl J Med 2002; 347(14):1057-1067.
  117. Weaver LK, Valentine KJ, Hopkins RO. Carbon monoxide poisoning: risk factors for cognitive sequelae and the role of hyperbaric oxygen. Am J Respir Crit Care Med 2007; 176(5):491-7.
  118. Weil M H, Becker L, Budinger T. et al. Workshop executive summary report: post-resuscitative and initial utility in life saving efforts (PULSE). Circulation. 2001; 103: 1182–1184.
  119. Wolf G, Cifu D, Baugh L et al. The effect of hyperbaric oxygen on symptoms after mild traumatic brain injury. J Neurotrauma 2012; 29(17):2606-2612.
  120. Wolf SJ, Lavonas EJ, Sloan EP et al. Clinical policy: Critical issues in the management of adult patients presenting to the emergency department with acute carbon monoxide poisoning. Ann Emerg Med 2008; 51(2):138-152.
  121. Xiao Y, Wang J, Jiang S et al. Hyperbaric oxygen therapy for vascular dementia. Cochrane Database Syst Rev 2012; 7:CD009425.
  122. Xie S, Qiang Q, Mei L, et al. Multivariate analysis of prognostic factors for idiopathic sudden sensorineural hearing loss treated with adjuvant hyperbaric oxygen therapy. Eur Arch Otorhinolaryngol. Jan 2018;275(1):47-51. 
  123. Xiong T, Chen H, Luo R, et al. Hyperbaric oxygen therapy for people with autism spectrum disorder (ASD). Cochrane Database Syst Rev. Oct 13 2016; 10:CD010922.
  124. Yildiz S, Kiralp MZ, Akin A, et al. A new treatment modality for fibromyalgia syndrome: hyperbaric oxygen therapy. J Int Med Res. May-Jun 2004; 32(3):263-267.
  125. Zandbergen E G, de Haan R J, Koelman J H. et al. Prediction of poor outcome in anoxic-ischemic coma. J Clin Neurophysol. 2000; 17(5): 498–501.
  126. Zandbergen E G, de Haan R J, Stoutenbeek C P. et al. Systematic review of early prediction of poor outcome in anoxic-ischaemic coma. Lancet. 1998; 352(9143): 1808-1812.

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.

 

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.