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Full-Body Monoplace or Multiplace Chamber Hyperbaric Oxygen Therapy
07.00.03q

Policy

MEDICALLY NECESSARY

Full-body hyperbaric oxygen (HBO) therapy is considered medically necessary and, therefore, covered when both the medical requirements and the technical requirements, as listed below, are met.

MEDICAL REQUIREMENTS
Full-body HBO therapy is considered medically necessary and, therefore, covered for the following indications:
  • Actinomycosis, only as an adjunct to conventional therapy when the disease process is refractory to antibiotics and surgical treatment  ​
  • Acute carbon monoxide intoxication 
  • Acute traumatic peripheral ischemia in combination with accepted standard therapeutic measures when loss of function, limb, or life is threatened 
  • Acute peripheral arterial insufficiency 
  • Air or gas embolism
  • Central retinal artery occlusion
  • Chronic refractory osteomyelitis that is unresponsive to conventional medical and surgical treatment
  • Compartment syndrome following the documented restoration of blood flow in combination with accepted standard therapeutic measures for decompression or removal of the flow-limiting condition of the limb when loss of function, limb, or life is threatened ​
  • Crushing injuries and suturing of severed limbs following the restoration of blood flow in combination with accepted standard therapeutic measures when loss of function, limb, or life is threatened 
  • Cyanide poisoning
  • Decompression illness​
  • Exceptional blood loss (anemia) when blood transfusion is impossible or must be delayed  
  • Gas gangrene (clostridial myositis or clostridial myonecrosis)
  • Intracranial abscess  
  • Idiopathic sudden sensorineural hearing loss (ISSNHL) of at least 30 decibels or more of pure-tone thresholds across three contiguous frequencies on audiogram when used in combination with steroid therapy within 2 weeks of symptom onset OR ​​​when combined with steroid therapy as salvage treatment within 1 month of symptom onset. 
  • Preparation and preservation of compromised skin grafts and flaps (not for primary management of wounds)  
  • Progressive necrotizing infections (i.e., necrotizing fasciitis) as an adjunct to surgical debridement and systemic antibiotics in settings where mortality and morbidity are expected to be high​
  • Prophylactic pre- and posttreatment for individuals who are undergoing non-implant–related dental surgery of a radiated jaw when the radiation therapy has been done at least 6 months prior
  • Delayed soft tissue radionecrosis (e.g., radiation enteritis, cystitis, proctitis) ​and other soft tissue radionecrosis​​​​ (e.g., breast, chest wall, pelvic organs [e.g., bladder, rectum]) as an adjunct to conventional treatment
  • Bony radionecrosis (osteoradionecrosis including the jaw) as an adjunct to conventional treatment​
  • Acute thermal skin burns ​​​​​
  • Diabetic wounds of the lower extremities, when all of the following criteria are met:
    • The individual has type 1 or type 2 diabetes and a lower extremity wound that is caused by diabetes
    • The wound is classified as Wagner Grade III or higher
    • The wound has not responded to an adequate course of standard wound therapy
    • The individual meets the criteria for initiation or continuation of full-body HBO:
    • Initiation of full-body HBO therapy to treat diabetic wounds of the lower extremities is considered medically necessary and, therefore, covered as adjunctive therapy when at least 30 consecutive days of standard wound therapy alone has produced no measurable signs of healing. Full-body HBO therapy must be used in addition to standard diabetic wound care measures such as: assessment of vascular status; correction of vascular problems in the affected limb if possible; optimization of nutritional status; optimization of glucose control; debridement by any means to remove devitalized tissue; maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings; appropriate off-loading; and necessary treatment to resolve any infection that might be present; OR
      • ​​​​Continued treatment of diabetic wounds with full-body HBO therapy is considered medically necessary and, therefore, covered if measurable signs of wound healing are evident after a 30-day period of treatment with both full-body HBO therapy and standard wound therapy. Wounds must be evaluated at least every 30 days during administration of HBO therapy. If no measurable signs of wound healing (defined as specific, documented, clinical signs of healing) are evident after any 30-day period, continued treatment with full-body HBO therapy is considered not medically necessary and, therefore, not covered.
TECHNICAL REQUIREMENTS
Full-body HBO therapy for the treatment of the conditions listed above is considered medically necessary and, therefore, covered when it is administered in a chamber (including the one-man unit) and the entire body is exposed to oxygen under increased atmospheric pressure​.

TRAINING AND CERTIFICATION REQUIREMENTS
HBO therapy will be covered in the non-hospital-affiliated setting when the facility demonstrates that all of the following criteria are met:
  1. Direct supervision is provided by a professional provider certified in Hyperbaric Medicine by the American Board of Emergency Medicine (ABEM), the American Board of Preventive Medicine (ABPM), or the American Osteopathic Conjoint Committee of Undersea and Hyperbaric Medicine (AOCUHM) or other entity adopting UHMS training protocol by completion of a minimum 40-hour training experience in a program approved by the American College of Hyperbaric Medicine or the Undersea and Hyperbaric Medical Society.
  2. The facility is accredited as a hyperbaric facility by an independent organization recognized by the Company.
EXPERIMENTAL/INVESTIGATIONAL

When full-body HBO therapy does not meet both the Medical Requirements and the Technical Requirements listed above, it is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Full-body HBO is considered experimental/investigational and, therefore, not covered for all other indications, including but not limited to the following because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature:
  • 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
  • Autism spectrum disorder
  • Bell palsy
  • Bisphosphonate-related osteonecrosis of the jaw
  • Bone grafts
  • Brown recluse spider bites
  • Carbon tetrachloride poisoning, acute
  • Cerebral edema, acute
  • Cerebral palsy
  • Cerebrovascular disease, acute (thrombotic or embolic) or chronic
  • Chronic arm lymphedema following radiotherapy for cancer
  • Chronic wounds, other than those in individuals​​​​​ with diabetes who meet the criteria specified in the medically necessary statement
  • Delayed-onset muscle soreness
  • Demyelinating diseases (e.g., multiple sclerosis, amyotrophic lateral sclerosis)
  • Early treatment (beginning at completion of radiotherapy) to reduce adverse events of radiotherapy
  • Fibromyalgia; and
  • Fracture healing
  • Herpes zoster
  • Hydrogen sulfide poisoning
  • Idiopathic femoral neck necrosis
  • In vitro fertilization
  • Inflammatory bowel disease (Crohn disease or ulcerative colitis)
  • Intra-abdominal abscesses
  • Lepromatous leprosy
  • Meningitis
  • Mental illness (i.e., posttraumatic stress disorder, generalized anxiety disorder or depression).
  • Migraine
  • Motor dysfunction associated with stroke
  • Pseudomembranous colitis (antimicrobial agent-induced colitis)​​​
  • Pyoderma gangrenosum
  • Radiation myelitis
  • Refractory mycoses: mucormycosis, conidiobolus​ coronatus
  • Retinal artery insufficiency, acute ​(other than central retinal artery occlusion)​
  • Retinopathy, adjunct to scleral buckling procedures in individuals​ with sickle cell peripheral retinopathy and retinal detachment
  • 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
  • Vascular dementia
BILLING REQUIREMENTS

Physician or other qualified health care professional attendance and supervision of HBO therapy, per session, as represented by Current Procedural Terminology (CPT) code 99183 is eligible to be reported when both the Medical Requirements and the Technical Requirements of full-body HBO therapy, as listed in this policy, are met.

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

Documentation includes the hyperbaric procedure (logs) with ascent time, descent time, and pressurization level. In addition, there should be a treatment plan identifying timeline and treatment goals.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

The Company reserves the right to review HBO services in consideration with the utilization guidelines listed in Attachment A.

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, full-body hyperbaric oxygen (HBO) therapy is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

However, services that are identified in this policy as not medically necessary are not eligible for coverage or reimbursement by the Company.

BILLING GUIDELINES

Physician or other health care professional attendance and supervision of HBO therapy may be billed using CPT code: 99183, when performed by a professional provider who is on-site.

Inclusion of a code in this policy does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The number of units reported for G0277 is based upon the time that the patient receives treatment with hyperbaric oxygen. The time spent by the patient under 100% oxygen, descent, air breaks, and ascent are included in calculating the total number of 30-minute intervals to be reported.

An additional unit of service may be reported if the patient is in the chamber receiving hyperbaric oxygen treatment for at least 16 minutes beyond the previous 30-minute period. The following guidelines instruct appropriate reporting of G0277:
  • The first unit reported must be at least 16 minutes in length.
  • The second unit is reported if the session is at least 46 minutes long (first unit = 30 minutes + 16 additional minutes).
  • The third unit is reported if the session is at least 76 minutes long (first and second units = 60 minutes + 16 additional minutes).
  • The fourth unit is reported if the session is at least 106 minutes long (first, second, and third units = 90 minutes + 16 additional minutes).
US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Several full-body monoplace and multiplace HBO chambers have received FDA approval.

WAGNER GRADE WOUND CLASSIFICATION

The Wagner classification system is used to assess wound parameters in individuals with diabetes, including the depth of penetration, the presence of osteomyelitis or gangrene, and the extent of tissue necrosis. The wound grades are defined as follows:

Grade 0 - No open lesion
Grade I - Superficial ulcer
Grade II - Ulcer penetrates to tendon, bone, or joint
Grade III - Ulcer penetrates deeper than Grade II and has evidence of abscess or osteomyelitis
Grade IV - Gangrene present in the toes or forefoot
Grade V - Gangrene present in the whole foot

Description

HYPERBARIC OXYGEN THERAPY

Originally developed for the treatment of decompression illness, hyperbaric oxygen (HBO) therapy is now used for the on-label and off-label management of a variety of medical conditions, such as air embolism, acute traumatic, thermal and radiation injuries, infections, and complicated wound management. HBO therapy involves the inhalation of 100 percent oxygen at an elevated (i.e., greater than sea-level) atmospheric absolute (ATA) of at least 1.4, although the pressure is typically between 2 and 3 ATA. The delivery system for HBO uses either a full-body monoplace (single person) chamber or a full-body multiplace (multiple person) chamber. In monoplace chambers, the entire chamber is pressurized with 100 percent oxygen to the desired ATA. Multiplace chambers, which can accommodate between two and 12 individuals, are pressurized using compressed air; the individual breathes 100 percent oxygen via mask, head tent, or endotracheal tube. In any of these settings, the arterial partial pressure of oxygen will approach 1500 mmHg. Individuals typically spend 1 to 2 hours in the chamber per session as determined by the professional provider.

Hyperbaric chambers are considered Class II devices by the US Food and Drug Administration (FDA). The indications for HBO therapy that are published by the Undersea and Hyperbaric Medical Society (UHMS) are also cited by the manufacturers of hyperbaric chambers to support the FDA labeling requirements for intended use. 

MECHANISM OF ACTION
HBO is used in the treatment of acute and chronic diseases and conditions in which oxygen delivery to tissue has been compromised by traumatic injury, infection, inflammation, or edema (swelling). The delivery of oxygen to the body under hyperbaric conditions, therefore, raises tissue oxygen levels and promotes recovery. The mechanisms of action for HBO therapy include displacing gas, decreasing edema, aiding the growth of new blood vessels (angiogenesis) and/or connective tissue (fibroblast proliferation), and killing bacteria.

COMPLICATIONS
Potential risks for individuals undergoing HBO therapy include pressure-related traumas (e.g., barotraumatic otitis, pneumothorax, middle ear effusion, and tympanic membrane rupture) and adverse effects (e.g., myopia, seizures) due to oxygen toxicity. Refraction changes are common but usually resolve once treatment is concluded. Hypoglycemia may be induced in diabetic individuals undergoing HBO therapy. Rapid ascent from pressure may cause decompression illness or "the bends." Some individuals may experience claustrophobia due to the confined chamber space.

PEER-REVIEWED LITERATURE​
Acute Coronary Syndrome

A Cochrane review by Bennett et al. (2015) identified six trials (N=665) evaluating HBOT for acute coronary syndrome. Included studies were published between 1973 and 2007. All studies included individuals with acute myocardial infarction; a study also included individuals with unstable angina. Additionally, all trials used HBOT, administered between 2 and 3 ATA, for 30- to 120-minute sessions, as an adjunct to standard care. Control interventions varied; only a trial described using a sham therapy to blind participants to treatment group allocation. In a pooled analysis of data from five trials, there was a significantly lower risk of mortality in individuals who received HBOT compared with a control intervention. Because of the variability of outcome reporting across studies, few other pooled analyses could be conducted. Three trials reported outcomes related to left ventricular function. One did not find a statistically significant improvement in contraction with HBOT, while two trials showed that left ventricular ejection fraction improved significantly with HBOT. Reviewers noted that although some evidence from small trials correlated HBOT with a lower risk of death, larger trials with high-quality methods were needed to determine which individuals, if any, could be expected to derive benefit from HBOT.

Acute Ischemic Stroke

​In a Cochrane systematic review of randomized controlled trials (RCTs), Bennett et al. (2014) evaluated HBOT for acute ischemic stroke. Reviewers identified 11 RCTs (N=705) that compared HBOT with sham HBOT or no treatment. Reviewers could pool study findings for only one outcome (mortality at 3 to 6 months), and no difference was detected between the treatment groups for that outcome. There was heterogeneity in the participants enrolled and in the clinical and functional outcomes measured across the studies. Additional RCT data are needed to permit conclusions on the impact of HBOT on the health outcome in individuals with acute ischemic stroke.

Autism Spectrum Disorder


A Cochrane review by Xiong et al. (2016) identified one RCT evaluating systemic HBOT for people with autism spectrum disorder that met eligibility criteria. Criteria included a hyperbaric oxygen intervention using 100% oxygen at more than 1 atm. The trial, published by Sampanthavivat et al. (2012), was considered low-quality evidence as assessed by the GRADE approach. The trial randomly assigned children with autism to receive 20 1-hour sessions with HBOT or sham air (n=30 per group). The primary outcome measures were change in Autism Treatment Evaluation Checklist and Clinical Global Impression scores, evaluated separately by clinicians and parents. There were no statistically significant differences between groups for either primary outcome. Posttreatment clinician-assessed mean scores on Autism Treatment Evaluation Checklist were 52.4 in the HBOT group and 52.9 in the sham air group.


Bell Palsy

Holland et al. (2012) published a Cochrane review evaluating HBOT in adults with moderate-to-severe Bell palsy. The literature search, conducted through January 2012, identified one RCT with 79 participants, but this trial did not meet reviewers’ prespecified selection standards because the outcome assessor was not blinded to treatment allocation. The trial was therefore excluded with no further analysis. There is a lack of evidence on use of HBOT for Bell palsy. Well-conducted RCTs are needed.

Bisphosphonate-Related Osteonecrosis of the Jaw

An unblinded RCT by Freiberger et al. (2012) evaluated the use of HBOT as an adjunct therapy for individuals with bisphosphonate-related osteonecrosis of the jaw.​ The investigators did a per-protocol analysis (actual treatment received) due to crossovers between the treatment groups. Participants were evaluated at 3, 6, 12, and 18 months. At 3 months, significantly more participants receiving HBOT as an adjunct to standard care experienced improvements in lesion size and number compared with individuals receiving only standard care. When the change from baseline to 6, 12, or 18 months was examined, there were no statistically significant differences between groups in the proportion of individuals with improvement or in the proportion of those who healed completely at any time point. This trial had a number of methodologic limitations (e.g., unblinded, crossover, per-protocol analysis rather than intention-to-treat). A disadvantage of the per-protocol analysis is that randomization is not preserved, and the two groups may differ on characteristics that affect outcomes. Additional evidence from RCTs is needed to permit conclusions on the impact of HBOT on health outcomes in individuals with bisphosphonate-related osteonecrosis of the jaw.

Cerebral Palsy


Two published RCTs were identified on the use of HBOT for cerebral palsy (CP). Lacey et al. (2012) published a double-blind RCT that included 49 children ages 3 to 8 years with spastic CP. Participants were randomly assigned to 40 treatments with HBOT or hyperbaric air to simulate 21% oxygen at room air. The primary efficacy outcome was change in the Gross Motor Function Measure global score. The trial was stopped early due to futility when an interim analysis indicated that there was less than a 2% likelihood that a statistically significant difference between groups would be found.


Collet et al. (2001) randomly assigned 111 children with CP to 40 treatments over a 2-month period of HBOT or slightly pressurized room air. Investigators found similar improvements in outcomes such as gross motor function and activities of daily living in both treatment groups.


An observational study by Long et al. (2017) evaluated the effects of HBOT as a treatment for sleep disorders in children with CP (N=71). Children between ages 2 and 6 years underwent 60-minute sessions of 100% oxygen, at 1.6 ATA, for 15 to 20 sessions total. Results showed improvements in average time to fall asleep, average hours of sleep duration, and an average number of night awakenings after 10 HBOT sessions compared with pretreatment.


Delayed-Onset Muscle Soreness

​​In a Cochrane review, Bennett et al. (2005; updated 2010) identified nine small RCTs on HBOT for delayed-onset muscle soreness and closed soft tissue injury. Included trials were published between 1996 and 2003. Methodologic quality was assessed as fair to high. Pooled analysis showed significantly higher pain in the group receiving HBOT compared with control. There were no between-group differences in long-term pain outcomes or other measures (e.g., swelling, muscle strength).


Fibromyalgia

​One delayed treatment RCT and a quasi-randomized trial on HBOT for fibromyalgia were identified.

Efrati et al. (2015) published an RCT that included 60 symptomatic women who had fibromyalgia for at least 2 years. Individuals were randomly assigned to an immediate 2-month course of HBOT or delayed HBOT after 2 months. Forty-eight (80%) of 60 individuals completed the trial. After the initial 2 months, outcomes including a number of tender points, pain threshold, and quality of life (QOL) (SF-36) were significantly improved in the immediate treatment group than in the delayed treatment group. After the delayed treatment group had undergone HBOT, outcomes were significantly improved compared with scores in the 2 months before HBOT treatment. These findings are not only consistent with the clinical benefit of HBOT but also with a placebo effect. A sham control trial is needed to confirm the efficacy of HBOT in the treatment of fibromyalgia and other conditions where primary endpoints are pain and other subjective outcomes.


Yildiz et al. (2004) assessed 50 individuals with fibromyalgia. On an alternating basis, individuals were assigned to HBOT or a control group. After HBOT treatment, the mean standard deviation, number of tender points, and mean visual analog scale scores were improved in individuals receiving HBOT compared with controls. It is unclear whether the control group received a sham intervention that would minimize any placebo effect (i.e., whether the control intervention was delivered in a hyperbaric chamber). The authors stated that the trial was double-blind, but did not provide details of patient blinding.


​Two RCTs assessing HBOT for fibromyalgia were identified. Both had relatively small sample sizes 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. Thus, the evidence is insufficient to permit conclusions on the impact of HBOT on health outcome​s for individuals with fibromyalgia.


Herpes Zoster 


Peng et al. (2012) in China published an RCT evaluating HBOT for herpes zoster. Sixty-eight individuals with herpes zoster were randomly assigned to HBOT with medication or medication treatment alone. The following outcomes were measured after 3 weeks of treatment: therapeutic efficacy, days to blister resolution, days to scar formation, and pain. Individuals receiving HBOT experienced significantly improved outcomes compared with individuals receiving medication alone. Limitations of the trial included a lack of blinding and long-term follow-up.

Idiopathic Femoral Neck Necrosis

A Cochrane review by Bennett et al. (2015) identified 11 RCTs (N=209) comparing the effectiveness of systemic HBOT for preventing or treating migraine headache or cluster headaches with another treatment or a sham control​. A pooled analysis of three trials focusing on migraine headaches (n=58) found a statistically significant increase in the proportion of individuals with substantial relief of migraine within 45 minutes of HBOT. No other pooled analyses were conducted due to variability in outcomes reported across trials. The meta-analysis did not report data on treatment effectiveness beyond the immediate posttreatment period, and the methodologic quality of selected trials was moderate to low (e.g., randomization was not well described in any trial).

Individuals with Cancer who are Undergoing Radiotherapy or Chemotherapy

​In a Cochrane review (2005), which was updated in 2012, Bennett et al. (2012) identified 19 randomized and quasirandomized trials (N=2286) comparing outcomes following radiotherapy with and without HBOT in individuals with solid tumors. The latest trial identified in the Cochrane search was published in 1999. Reviewers did not find any ongoing RCTs in this area. Results from the review reported that HBOT given with radiotherapy might be useful in tumor control in head and neck cancer. However, reviewers expressed caution because significant adverse events, such as severe radiation tissue injury (relative risk, 2.3; P<0.001) and seizures (relative risk, 6.8; P=0.03) occurred more frequently in individual​s treated with HBOT. The RCT did not find a significant difference in survival in individuals with cancer who received HBOT before chemotherapy.​​
​

Irritable Bowel Disease


A systematic review by McCurdy et al. (2022) examined the evidence on HBOT for a range of IBD phenotypes (Crohn disease, ulcerative colitis). The review was not limited by study design, and it included three small RCTs ( N=40) and 16 case series. All three of the RCTs were conducted in individuals with ulcerative colitis. The included case series generally enrolled less than 30 participants each, with the exception of one study, conducted in Russia, that enrolled 519 individual​​​s. Overall, a total sample size for the systematic review across phenotypes was 844.​​ Results from the individual RCTs were mixed. Two RCTs found a benefit for HBOT compared with standard medical care, but they were small studies (n=10 and 20) and were likely underpowered to detect between-group differences. In addition, one of the trials only included prior HBOT responders and one was stopped early due to enrollment difficulties. The third RCT found no benefit of HBOT compared with standard care and was also stopped early due to futility. Quality assessment of the included studies judged two of the three included RCTs to be at high risk of bias. The study authors concluded that although HBOT was associated with high response rates across phenotypes, high-quality evidence was very limited, and well-designed RCTs are needed to confirm the effect of HBOT in individuals with IBD.


Migraine Headache

A Cochrane review by Bennett et al. (2015) identified 11 RCTs (N=209) comparing the effectiveness of systemic HBOT for preventing or treating migraine headache or cluster headaches with another treatment or a sham control​​​​​​​​. A pooled analysis of three trials focusing on migraine headaches (n=58) found a statistically significant increase in the proportion of individuals with substantial relief of migraine within 45 minutes of HBOT. No other pooled analyses were conducted due to variability in outcomes reported across trials. The meta-analysis did not report data on treatment effectiveness beyond the immediate posttreatment period, and the methodologic quality of selected trials was moderate to low (e.g., randomization was not well described in any trial).​

​Motor Dysfunction Associated with Stroke

Efrati et al. (2013) published an RCT evaluating HBOT for the treatment of neurologic deficiencies associated with a history of stroke. Individuals in the treatment group were evaluated at baseline and 2 months. For individuals in the delayed treatment control group, outcomes were evaluated at 4 months after crossing over and receiving HBOT. Outcome measures included the National Institutes of Health Stroke Scale, which was measured by physicians blinded to the treatment group, and several patient-reported QOL and functional status measures. At the 2-month follow-up, there was a statistically significant improvement in function in the HBOT group compared with the control group, as measured by the National Institutes of Health Stroke Scale, QOL scales, and the ability to perform activities of daily living. These differences in outcome measures were accompanied by improvements in single-photon emission computed tomography imaging in the regions affected by stroke. For the delayed treatment control group, there was a statistically significant improvement in function after HBOT compared with before HBOT. This RCT raises the possibility that HBOT may induce improvements in function and QOL for poststroke individuals with motor deficits. However, the results are not definitive, as the RCT was small and enrolled a heterogeneous group of poststroke individuals. The trial was not double-blind and most outcome measures, except for National Institutes of Health Stroke Scale, were patient-reported and prone to the placebo effect. Also, there was a high total dropout rate (20%) at the 2-month follow-up. Larger, double-blind studies with longer follow-up are needed to corroborate these results.

Multiple Sclerosis

Bennett et al. (2010) published a systematic review on the use of HBOT for treatment of MS. Nine RCTs (N=504) were identified that compared the effects of HBOT with placebo or no treatment. All trials used an initial course of 20 sessions over 4 weeks, although dosages among studies varied from 1.75 ATA for 90 minutes to 2.5 ATA for 90 minutes. The primary outcome of the review was the Expanded Disability Status Scale score. A pooled analysis of data from five trials (n=271) did not find a significant difference in mean Expanded Disability Status Scale score change after 20 HBOT treatments versus control or after 6 months of follow-up.​

Traumatic Brain Injury

​A meta-analysis by Wang et al. (2016) assessed HBOT for traumatic brain injury (TBI). ​​E​ight studies (N=519) met the eligibility criteria. HBOT protocols varied across studies in the levels of oxygen and the length and frequency of treatments. The primary outcome was change in the Glasgow Coma Scale score. A pooled analysis of two studies found a significantly greater improvement in the mean Glasgow Coma Scale score in the HBOT group compared with control groups. Mortality (a secondary outcome) was reported in three of the eight studies. Pooled analysis of these three studies found a significantly lower overall mortality rate in the HBOT group than in the control group.

Another systematic review by Crawford et al. (2016) did not conduct pooled analyses. Reviewers identified 12 RCTs evaluating HBOT for individuals with TBI. Using the Scottish Intercollegiate Guidelines Network (SIGN) 50 criteria, eight trials were rated acceptable and four were rated low. Four trials, all rated as having acceptable quality, addressed individuals with mild TBI and compared HBOT with sham. None found statistically significant differences between groups on outcomes (i.e., postconcussive symptom severity, psychological outcomes). Seven trials evaluated HBOT for the acute treatment of individuals with moderate-to-severe TBI. Four were rated as acceptable quality and three as low quality. Study protocols and outcomes varied and none used a sham control. Three acceptable quality studies with standard care controls reported the Glasgow Outcome Scale score and mortality rate. In two of them, outcomes were better with HBOT than with standard care; in the third study, outcomes did not differ significantly.


A Cochrane review by Bennett et al. (2012) evaluated HBOT as adjunctive therapy for acute TBI​. Reviewers identified seven RCTs comparing a standard intensive treatment regimen with the same treatment regimen plus HBOT. Reviewers did not include studies with interventions in specialized acute care settings. The HBOT regimens varied among studies; e.g., the total number of individual sessions varied from three to 40. None of the trials used sham treatment or blinded staff treating participants, and only one had blinding of outcome assessment. Allocation concealment was inadequate in all studies. The primary outcomes of the review were mortality and functional outcomes. A pooled analysis of data from four trials showed that adding HBOT to standard care decreased mortality, but did not improve functional outcome at final follow-up. The unfavorable functional outcome was commonly defined as a Glasgow Outcome Scale score of 1, 2, or 3, which are described as “dead,” “vegetative state,” or “severely disabled,” respectively. Studies were generally small and judged to have a substantial risk of bias.


The systematic review and pooled analysis by Hart et al. (2019) evaluated HBOT for mild traumatic brain injury (mTBI)-associated postconcussive symptoms (PCS) and posttraumatic stress disorder (PTSD). Data were aggregated from four Department of Defense (DoD) studies that included participant-level data on 254 individuals assigned to either HBOT or sham intervention. An additional three studies with summary-level participant data were summarized (n=135). The authors assessed changes from baseline to postintervention on PCS, PTSD, and neuropsychological measures​. The DoD data analyses indicated improvements with HBOT for PCS, measured by the Rivermead Total Score. Statistically significant improvements were seen for PTSD based on the PTSD Checklist Total Score, as well as for verbal memory based on the California Verbal Learning Test (CVLT)-II Trial 1-5 Free Recall.


The DoD-sponsored RCT, titled Brain Injury and Mechanisms of Action in Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury (mTBI) (BIMA), completed in 2016, was the first to include post​intervention follow-up beyond 3 to 6 months. Hart et al. (2019) described BIMA, which assessed HBOT for US service members with mTBI. BIMA was initially planned for a 12-month follow-up, but was amended to include PCS and PTSD, QOL, pain, depression, anxiety, and alcohol use assessments at 24 and 36 months. Investigators saw no significant differences at 24 or 36 months between the HBOT and sham groups, and group mean scores had returned to near pre-intervention values. Churchill et al. (2019) reported on the chamber- and protocol-related adverse events (AEs) in the trial titled A Pilot Phase II Study of Hyperbaric Oxygen for Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury (HOPPS) and BIMA trial. In addition to AEs, they assessed the success of maintaining the blind with a low-pressure sham control group. Of the total 4245 chamber sessions, AEs were rare, at 1.1% in the HOPPS study and 2.2% in BIMA. Most AEs were minor, nonlimiting barotrauma, and headaches. Results of a questionnaire that followed the intervention showed that the sham group blind was adequately maintained in both trials.


Weaver et al. (2019) evaluated BIMA and a second RCT of U.S. service members for the efficacy of HBOT in treating persistent PCS after mTBI. The second study, HOPPS, was completed in 2012. The three outcomes assessed in the pooled analyses of the two studies were symptoms, cognitive impairment, and functional impairment; they were weighted and grouped into different domains to calculate the composite outcome score. A total of 143 service members were randomly assigned to receive either HBOT (1.5 ATA, >99% oxygen) or sham therapy (1.2 ATA, room air). In HOPPS, composite total scores improved from baseline for HBOT (mean, −2.9 ± 9.0) and sham treatment (−2.9 ± 6.6), but the groups did not differ significantly from each other (P=0.33). The BIMA trial results showed a greater improvement from baseline in the HBOT group (−3.6 ± 6.4) versus sham (−0.3 ± 5.2; p=.02). The authors concluded that composite total scores in HOPPS and BIMA were consistent with primary study results.​


Several RCTs and systematic reviews have been published. Pooled analyses were only conducted on a minority of the published RCTs, and these analyses had inconsistent findings. Additionally, there was overlap in RCTs included in the reviews. There is a lack of consistent evidence from well-conducted trials that HBOT improves the health outcome for individuals with TBI. 


Vascular Dementia


​A Cochrane review (2012) identified a small RCT evaluating HBOT for vascular dementia. This 2009 RCT, conducted in China, compared HBOT (30-day cycles of 1 hour/day for 24 days and 6 days of rest) plus donepezil to donepezil-only in 64 individuals. The HBOT-plus-donepezil group had significantly improved cognitive function after 12 weeks of treatment, although the confidence intervals were wide due to the small sample size. Reviewers judged the trial to be of poor quality because it was not blinded and the methods of randomization and allocation concealment were not discussed. This trial provided insufficient evidence to permit conclusions on the impact of HBOT on health outcomes in individuals with vascular dementia.


Other Indications


For the indications listed below, literature searches did not identify sufficient evidence to support the use of HBOT, such as systematic reviews and/or multiple well-conducted RCTs directly relevant to U.S. settings, assessing:

  • ​Bone grafts

  • Carbon tetrachloride poisoning, acute

  • Cerebrovascular disease, acute (thrombotic or embolic) or chronic

  • Fracture healing;

  • Hydrogen sulfide poisoning

  • Intra-abdominal abscesses

  • Lepromatous leprosy

  • Meningitis

  • Pseudomembranous colitis (antimicrobial agent-induced colitis)

  • Sickle cell crisis and/or hematuria

  • Amyotrophic lateral sclerosis

  • Retinal artery insufficiency, acute (other than central retinal artery occlusion)​

  • Retinopathy, adjunct to scleral buckling procedures in individuals with sickle cell peripheral retinopathy and retinal detachment

  • Pyoderma gangrenosum

  • Brown recluse spider bites

  • Spinal cord injury

  • Refractory mycoses

  • Acute peripheral arterial insufficiency

  • In vitro fertilization

  • Mental illness​

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US Food and Drug Administration (FDA). Center for Devices and Radiologic Health. HyperOx 101 Multiplace Hyperbaric Oxygen Treatment Chamber. 510(k) summary. [FDA Web site]. 03/15/2006. Available at: http://www.accessdata.fda.gov/c​drh_docs/pdf5/K053498.pdf. Accessed January 23, 2025. 

US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Sigma Elite XX Monoplace Hyperbaric Chamber. 510(k) summary. [FDA Web site]. 07/11/2008. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/K072427.pdf. Accessed January 23, 2025. 

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.

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.​​​

Villeirs L, Tailly T, Ost P, et al. Hyperbaric oxygen therapy for radiation cystitis after pelvic radiotherapy: Systematic review of the recent literature. Int J Urol. 2020;27(2):98-107. ​

Virginia Commonwealth University. Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI) (NCT01220713). [Clinical Trials Web site]. 08/27/2013. Available at: https://clinicaltrials.gov/ct2/show/NCT01220713?term=NCT01220713&rank=1. Accessed January 23, 2025. ​

Wang F, Wang Y, Sun T, et al. Hyperbaric oxygen therapy for the treatment of traumatic brain injury: a meta-analysis. Neurol Sci. 2016;37(5):693-701.

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;46(3):341-352. ​

Weaver LK, Hopkins RO, Chan KJ, et al. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl J Med. 2002;347(14):1057-1067.

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):491-497.

Weber PC. Sudden sensorineural hearing loss in adults: evaluation and management. Up to Date. [UpToDate Web site]. 10/02/2024. Available at: http://www.uptodate.com/home/index.html [via subscription only]. Accessed January 23, 2025. ​​

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.

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.

Xiao Y, Wang J, Jiang S, et al. Hyperbaric oxygen therapy for vascular dementia. Cochrane Database Syst Rev. 2012;7:CD009425.​
​​
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. 2018;275(1):47-51. 

Xiong T, Chen H, Luo R, et al. Hyperbaric oxygen therapy for people with autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2016;10:CD010922. 
Yildiz S, Kiralp MZ, Akin A, et al. A new treatment modality for fibromyalgia syndrome: hyperbaric oxygen therapy. J Int Med Res. 2004;32(3):263-267.

Coding

CPT Procedure Code Number(s)
99183
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.
HCPCS Level II Code Number(s)
G0277 Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval​
Revenue Code Number(s)

0413 Hyperbaric oxygen therapy​



Coding and Billing Requirements

Policy History

Revisions From 07.00.03q:
04/21/2025
This version of the policy will become effective 04/21/2025. 

The intent of this policy remains unchanged; however, medically necessary criteria were added for central retinal artery occlusion. 

In addition, the policy criteria section has been revised to include idiopathic sudden sensorineural hearing loss (ISSNHL)​ when used in combination with steroid therapy within 2 weeks of symptom onset OR when combined with steroid therapy as salvage treatment within 1 month of symptom onset. 

Attachment A Utilization Guidelines were revised to Recommended Treatment Dose and Typical Number of Treatment Sessions (per the Undersea and Hyperbaric Medical Society (UHMS) Hyperbaric Medicine Indications Manual [15th edition, 2023]).

Revisions From 07.00.03p:
​06/26/2024
​This policy has been reissued in accordance with the Company's annual review process.​
11/15/2023
This version of the policy will become effective 11/15/2023. 

The intent of this policy remains unchanged, however, the policy criteria section has been revised to include Idiopathic sudden sensorineural hearing loss (ISSHL) as medically necessary with criteria. ​

In addition, the Company’s coverage position has changed from Not Medically Necessary to Experimental/Investigational when the Medical Requirements and Technical Requirements of this policy are not met and/or for all other uses for Hyperbaric Oxygen not listed in the medically necessary section of the policy. 

An Experimental/Investigational section with examples was added to the policy. ​​

Revisions From 07.00.03o:
09/07/2022

This policy has been reissued in accordance with the Company's annual review process.

​01/31/2022
​This version of the policy will become effective 01/31/2022.
The intent of this policy remains unchanged, however, the policy section of the document has been revised with conditional criteria for specific indications. 

​Revisions From 07.00.030n:
11/18/2020

The policy has been reviewed and reissued to communicate the Company’s continuing position on Full-Body Monoplace or Multiplace Chamber Hyperbaric Oxygen Therapy​.
​12/18/2019

​This policy has been reissued in accordance with the Company's annual review process.
​03/28/2018
​The policy has been reviewed and reissued to communicate the Company’s continuing position on hyperbaric oxygen therapy.

Effective 10/05/2017 this policy has been updated to the new policy template format.
4/21/2025
4/21/2025
07.00.03
Medical Policy Bulletin
Commercial
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No
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Independence Blue Cross is a subsidiary of Independence Health Group, Inc. — independent licensees of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.