BlueCross and BlueShield of Montana Medical Policy/Codes
Hyperbaric Oxygen (HBO2) Pressurization
Chapter: Medicine: Treatments
Current Effective Date: October 25, 2013
Original Effective Date: February 12, 2013
Publish Date: July 25, 2013
Revised Dates: February 12, 2003; September 14, 2005; March 1, 2010; April 19, 2012; October 19, 2012; July 11, 2013
Description

Hyperbaric oxygen (HBO2) pressurization therapy is a technique of delivering higher pressures of oxygen (O2) to the tissues. Two methods of delivery are available, systemic and topical.

In systemic or large chamber HBO2, the patient is entirely enclosed in a pressure chamber and breathes pure 100% O2 at a pressure greater than 1 atmosphere (atm) (the pressure of O2 at sea level). This technique relies on systemic circulation to deliver highly oxygenated blood to the target site, typically a wound. In addition, systemic HBO2 therapy can be used to treat systemic illness such as air or gas embolism, carbon monoxide poisoning, clostridial gas gangrene, etc. Treatment may be carried out either in a monoplace (single patient unit) chamber pressurized with pure O2 or in a larger, multiplace (multiple patient unit) chamber pressurized with compressed air, in which case the patient receives pure O2 by mask, head tent, or endotracheal tube. A cycle of pressurization, with or without air breaks, inside an HBO2 chamber may be called “a dive”, which may last for 90 minutes or more. (NOTE:  Breathing 100% O2 at one atmosphere WITHOUT the use of a pressurized chamber is NOT considered to be HBO2 pressurization.)

Topical HBO2 (THBO2) therapy describes a technique of delivering 100% O2 directly to an open, moist wound at a pressure slightly higher than atmospheric pressure. It is hypothesized that high concentrations of O2 diffused directly into the wound, increases the local cellular O2 tension, which in turn promotes wound healing. THBO2 devices consist of an appliance to enclose the wound area (frequently an extremity) and a source of O2. The appliances may be disposable and have been used without supervision in the home. THBO2 may be performed in the provider office, clinic, or may be self-administered by the patient at home. Typically, the therapy is offered for 90 minutes per day for 4 consecutive days. After a 3-day break, the cycle is repeated. This regimen may last for 8- to 10-weeks. THBO2 therapy has been investigated as a treatment of skin ulcerations due to diabetes, venous stasis, postsurgical infection, gangrene, decubitus, compromised amputations or skin grafts, burns, or frostbite.

Systemic HBO2 is a generally accepted medical treatment. HBO2 services include both consultative and therapeutic services. The HBO2 physician, certified by the American College of Hyperbaric Medicine (ACHM) and American College of Preventive Medicine (ACPM), must be actively present during all treatments.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Therapy with systemic hyperbaric oxygen (HBO2) pressurization may be considered medically necessary for the medical conditions and circumstances listed below. ALL requests and claims must include documentation of medical necessity.

ALL the following documentation requirements for systemic HBO2 pressurization therapy must ACCOMPANY requests and claims for treatment:

  • When services are in excess of 1-month duration, AND/OR when services are in excess of the number of treatments previously listed or listed as individual consideration; AND
  • Documentation must be reviewed for medical necessity; AND
  • Documentation must include at least two of the following:
    1. Photographs, AND/OR
    2. Consultation reports, AND/OR
    3. Operative or treatment reports and/or other applicable hospital records (e.g., pathology report, history and physical), AND/OR
    4. Office records; AND/OR
  • Documentation of wounds should include the following:
    1. Primary diagnosis,
    2. Secondary diagnosis,
    3. Contributing factors to the primary diagnosis,
    4. Co-morbid factors,
    5. Prior therapy,
    6. Wound description (cause, location, measurements [size, depth, undermining, granulation]),
    7. Wagner classification system grade level (see NOTE 1 below in grid), AND
    8. Whether this is initial treatment or extension of treatment.

NOTE:  The prior approval process may be a useful method of establishing medical necessity.

The medical conditions and circumstances that may be considered medical necessary are listed in the grid below. This includes the number of treatments initially allowed for each approved condition. Approval of treatment or services beyond the number initially authorized requires review of pertinent medical record documentation. Additional information about these requirements is contained within the policy document.

IF THE MEDICALLY NECESSARY DIAGNOSIS IS:

THEN REVIEW:

Diabetic wounds, which include foot wounds or marginally perfused wounds, non-healing of the lower extremities in diabetic patients who meet ALL the following three criteria:

  • Patient has type I or type II diabetes and has a lower extremity wound that is due to diabetes, AND
  • Patient has a wound classified as Wagner grade-3 or higher (see NOTE 1), AND
  • Patient has no measurable signs of healing after 30 days of an adequate course of standard wound therapy.

NOTE 1:  The Wagner classification system of wounds is defined as follows:

  • Grade-0 =  no open lesion;
  • Grade-1 = superficial ulcer without penetration to deeper layers;
  • Grade-2 = ulcer penetrates to tendon, bone, or joint;
  • Grade-3 = lesion has penetrated deeper than grade-2 and there is abscess, osteomyelitis, pyarthrosis, plantar space abscess, or infection of the tendon and tendon sheaths;
  • Grade-4 =  wet or dry gangrene in the toes or forefoot; and,
  • Grade-5 =  gangrene involves the whole foot or such a percentage that no local procedures are possible and amputation (at least at the below the knee level) is indicated.

NOTE 2: Treatments are usually given daily for 90- to 120-minutes. The initial treatment depends on severity of disease. More serious may require twice daily treatments; and once stabilized treatments may be done once daily.

After 30 treatments.

 

 

(see NOTE 1 and 2)

 

Chronic refractory osteomyelitis.

After 30 treatments.

Soft-tissue radiation necrosis (i.e., radiation enteritis, cystitis, proctitis) and osteoradionecrosis (ORN).

NOTE 3: For soft-tissue radiation necrosis, review is required after each 20 treatments. Treatments are usually given daily for 90 to 120 minutes. Beyond 60 treatments, individual consideration is applied.

NOTE 4: For ORN, the initial course of treatment for patients with Stage I osteoradionecrosis will include HBO2 followed by débridement. Stage II, if the patients are not responding, more extensive débridement, followed by additional HBO2. For patients presenting at Stage III, HBO2 is started followed by mandibular segmental resection with additional HBO2 therapy. Beyond the initial therapy course, individual consideration is applied.

After 20 treatments.

 

(see NOTE 3 and 4)

 

Crush injury, reperfusion injury, compartment syndrome, and other acute traumatic ischemias.

NOTE 5:  Three treatments per day for 48-hours followed by two treatments per day over the second 48-hours and one treatment per day over the third period of 48-hours. Beyond this time period, individual consideration is applied.

After 12 treatments.

 

(see NOTE 5)

Venous stasis ulcers, only if venous surgery, local wound care, leg elevation, counterpressure support, and skin grafting fails for patients who have a wound classified as Wagner grade-3 or higher (see NOTE 1).

NOTE 1:  The Wagner classification system of wounds is defined as follows:

  • Grade-0 =  no open lesion;
  • Grade-1 = superficial ulcer without penetration to deeper layers;
  • Grade-2 = ulcer penetrates to tendon, bone, or joint;
  • Grade-3 = lesion has penetrated deeper than grade-2 and there is abscess, osteomyelitis, pyarthrosis, plantar space abscess, or infection of the tendon and tendon sheaths;
  • Grade-4 =  wet or dry gangrene in the toes or forefoot; and,
  • Grade-5 =  gangrene involves the whole foot or such a percentage that no local procedures are possible and amputation (at least at the below the knee level) is indicated.

After 12 treatments.

 

(see NOTE 1)

 

 

Compromised skin grafts or flaps, or for enhancement of healing in selected problem wounds.

After 12 treatments. 

Gas gangrene (i.e., clostridial myonecrosis) and includes Meleney's postoperative gangrene ulcer.

NOTE 6: Treatments may be as often as three during the first 24-hours for 90-minutes, then 2-sessions per day for the next 2- to 5-days, depending on the patient’s initial response.

After 10 treatments.

 

(see NOTE 6)

Soft tissue infections due to mixed aerobic and anaerobic organisms with tissue necrosis and refractory bacteroides infections.

After 10 treatments. 

Decompression sickness.

NOTE 7 Treatment times vary; depending on length of time elapsed between symptoms and initiation of treatment and between residual symptoms after initial treatment. The majority of cases respond to a single treatment. Usual time between treatments ranges from 90-minutes to 14-hours. Repetitive treatments may be necessary, depending on the patient’s response.

After 10 treatments.

 

(see NOTE 7)

Acute air or gas embolism.

After 10 treatments.

Brown recluse spider bites.

After 5 treatments.

Acute carbon monoxide poisoning (intoxication) and smoke inhalation (not chronic) and may be complicated by cyanide poisoning.

NOTE 8: Treatments will vary based on persistent neurologic dysfunction after the initial treatment and may be as frequent as once or twice daily, until there is no additional improvement in cognitive function.

After 5 treatments.

 

(see NOTE 8)

Thermal burns, second or third degree burns involving 15% to 90% of total body surface and initiated within 24 hours of the burn injury.

After 5 treatments. 

Idiopathic sudden sensorineural hearing loss (ISSNHL).

After 5 treatments

Acute cyanide poisoning, and may be complicated by carbon monoxide poisoning.

NOTE 8: Treatments will vary based on persistent neurologic dysfunction after the initial treatment and may be as frequent as once or twice daily, until there is no additional improvement in cognitive function.

For individual consideration of number of treatments.

 (see NOTE 8)

Exceptional blood loss anemia (profound/severe), as the result of class IV hemorrhage, HBO2 is indicated when the patient will not accept blood replacement for medical or religious reasons and the following symptoms are present:

  • Shock, systolic blood pressure below 90 mm Hg, or pressure maintained by vasopressors; AND
  • Disorientation to coma; AND
  • Ischemic changes of the myocardium as demonstrated on the electrocardiogram (EKG);  AND
  • Ischemic gut.

NOTE 9:  HBO2 therapy is continued as needed and discontinued when the red blood cells have been replaced in numbers to alleviate the precipitating signs and symptoms.

For individual consideration of number of treatments.

 

(see NOTE 9)

Selected refractory mycoses (mucormycosis, actinomycosis, or canibolis coronato).

For individual consideration of number of treatments.

Intracranial abscess.

For individual consideration of number of treatments.

Acute cerebral edema.

For individual consideration of number of treatments.

Arterial insufficiency ulcer (not acute) which persists after reconstructive surgery has restored large vessel perfusion (includes peripheral vessels).

For individual consideration of number of treatments.

Decubitus ulcers.

For individual consideration of number of treatments.

Pre- and post-treatment for patients undergoing dental surgery (non-implant-related) of an irradiated jaw.

For individual consideration of number of treatments.

Comment: A course of treatment may range from less than one week to several months duration, depending on the severity of the patient's condition and response to therapy. The average length of treatment is two to four weeks.

Systemic HBO2 pressurization therapy is considered experimental, investigational and unproven, including but not limited to the following indications or clinical conditions and any diagnosis not previously listed as covered:

  • Actinic keratosis (AK) or actinic skin damage,
  • Amyotrophic lateral sclerosis (ALS);
  • Arterial peripheral insufficiency, acute;
  • Autistic spectrum disorders (ASD);
  • Avascular necrosis;
  • Bell’s palsy;
  • Bone grafts;
  • Carbon tetrachloride poisoning, acute;
  • Cerebral palsy (CP);
  • Cerebrovascular accident (CVA), acute thrombotic or embolic, or chronic;
  • Coronary syndromes, acute, and as an  adjunct to coronary interventions, including but not limited to percutaneous coronary interventions (PCI) and cardiopulmonary bypass;
  • Crohn’s disease (CD), severe or refractory;
  • Fracture healing;
  • Head (brain) and spinal cord injury, traumatic;
  • Hydrogen sulfide poisoning;
  • Idiopathic femoral neck necrosis;
  • Ileus, postoperative;
  • Intra-abdominal abscesses;
  • In vitro fertilization (IVF);
  • Ischemic stroke, acute;
  • Lepromatous leprosy;
  • Lyme disease (LD);
  • Lymphedema of arm, chronic, following radiotherapy for cancer;
  • Meningitis;
  • Migraine or cluster headaches;
  • Multiple sclerosis (MS);
  • Muscle soreness, delayed onset;
  • Myocardial infarction (MI), acute;
  • Osteomyelitis, acute;
  • Pancreatitis, acute;
  • Pseudomembranous colitis, antimicrobial agent-induced colitis;
  • Pyoderma gangrenosum;
  • Radiation-induced injury to head, neck, anus, or rectum (except proctitis);
  • Radiation necrosis of non-neurologic tissue;
  • Radiation-myelitis;
  • Radiation therapy, adverse effects, at any point of therapy, including early onset effects and delayed effects (i.e., extremity lymphedema associated with cancer radiation);
  • Retinal artery insufficiency, acute within the first 24 hours of diagnosis;
  • Retinopathy, as an adjunct to scleral buckling procedure in patients with sickle cell peripheral retinopathy and retinal detachment;
  • Sickle cell crisis (SCC) and/or hematuria;
  • Surgical and traumatic wounds, acute;
  • Sudden deafness (unrelated to ISSNHL); AND
  • Tumor sensitization for cancer treatments includes but not limited to, radiotherapy or chemotherapy.

Therapy with topical HBO2 (THBO2) pressurization for any indication or clinical condition is considered experimental, investigational and unproven.

Policy Guidelines

HCPCS code A4575 is used to describe the disposable appliance that is positioned around the wound area for THBO2 therapy.  Conventional O2 tanks, typically gas, are used to supply the O2.

Rationale

The original policy on systemic hyperbaric oxygenation or hyperbaric oxygen (HBO2) pressurization was based upon the 1996 guidelines published by the Undersea and Hyperbaric Medical Society (UHMS).(1) The UHMS published new guidelines in June 2003 in which their Hyperbaric Oxygen Therapy Committee (2) continues to consider HBO2 to be appropriate for these conditions:

  • Air or gas embolism;
  • Carbon monoxide poisoning and carbon monoxide complicated by cyanide poisoning;
  • Clostridal myositis and myonecrosis (gas gangrene);
  • Crush injury, compartment syndrome and other acute traumatic ischemias;
  • Decompression sickness;
  • Enhancement of healing in selected problem wounds;
  • Exceptional blood loss (anemia);
  • Intracranial abscess;
  • Necrotizing soft tissue infections;
  • Osteomyelitis (refractory);
  • Delayed radiation injury (soft tissue and bony necrosis);
  • Skin grafts and flaps (compromised); AND
  • Thermal burns.

As of the January 2007 update, the UHMS has not changed their indications for systemic HBO2 pressurization therapy from those conditions listed above. Literature also states systemic HBO2 should not replace standard, successful therapeutic treatment courses, used to treat conditions that will improve under higher oxygen pressurization to body tissues. (3, 4)

The literature review also examined the role of systemic HBO2 as a treatment modality (3, 4) for indications listed as experimental, investigational and unproven. This includes, but is not limited to, acute ischemic stroke, acute coronary syndromes as an adjunct to percutaneous coronary intervention (PCI), idiopathic sudden sensorineural hearing loss, migraine, amyotrophic lateral sclerosis (ALS), in vitro fertilization (IVF), Crohn’s disease (CD), acute peripheral arterial insufficiency, and cerebral palsy (CP).

Acute Ischemic Stroke

Rusyniak and colleagues reported on the results of a randomized, double-blind sham-controlled study of 33 patients presenting with acute ischemic stroke who were randomized to active or sham HBO2. (5) No beneficial effect was reported for HBO2.

Acute Myocardial Infarction (MI)

Sharifi and colleagues reported on a trial that randomized 69 patients with unstable angina or acute MI to receive or not receive HBO2 after PCI. (6) The rationale behind this investigation was that HBO2 therapy might accelerate the healing of the microtrauma associated with PCI and thus ultimately reduces the restenosis rate. The 24 patients randomized to the HBO2 group reported only one adverse event (death, MI, coronary artery bypass, or revascularization of target lesion), compared to 13 in the 37 control patients. However, this study lacks adequate detail to provide scientific conclusions. For example, details of the type of PCI performed, such as whether a drug eluting stent was used, were not provided. In addition, a Cochrane review of four trials with a total of 462 patients concluded there were no significant benefits for patients with acute coronary syndromes receiving HBO2. (7)

Hearing Loss

Topuz and colleagues reported on a trial that randomized 51 patients with sudden idiopathic sensorineural hearing loss to receive conventional therapy, such as steroids, plasma expanders, with or without HBO2. (8) Audiologic assessments were performed immediately after treatment. While the HBO2 group reported gains in hearing at some frequencies, this small trial with short follow-up is inadequate to permit scientific conclusions. A Cochrane review of five trials with a total 254 patients also concluded that the data are insufficient to determine the clinical significance of hearing improvement with the use of HBO2 therapy in patients with idiopathic sensorineural hearing loss. (9)

Migraines

In a randomized, double-blind, placebo-controlled study of 40 patients, Eftedal and colleagues reported no significant reductions in migraine occurrence with HBO2 therapy compared to hyperbaric air treatments. (10)

Amyotrophic Lateral Sclerosis (ALS)

Steele et al. treated five patients with ALS with HBO2 and reported some improvements in fatigue but noted further study is needed and attention to placebo effects must be given. (11)

InVitro Fertilization (IVF)

Van Voorhis and colleagues reported HBO2 was well tolerated in women undergoing ovarian follicular stimulation for IVF, however, no outcomes were reported, and further study is needed. (12)

Crohn’s Disease (CD)

The 1999 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment reported the available evidence supporting severe or refractory CD consisted of case reports, small uncontrolled case series, and one case-controlled report that observed intermediate outcomes only. (13, 14, 15) The TEC Assessment concluded that there was insufficient evidence to permit conclusions.

Acute Peripheral Arterial Insufficiency

No clinical trial publications were identified that demonstrated benefit in HBO2 therapy for acute peripheral arterial insufficiency, and thus the evidence basis for coverage by Medicare is unclear as Medicare has long listed acute peripheral arterial insufficiency as a medically necessary indication. Due to the lack of published literature, acute peripheral arterial insufficiency is listed as an experimental, investigational and unproven indication.

Cerebral Palsy (CP)

Collet et al randomized 111 children with CP to 40 treatments over a two-month period of either HBO2 or slightly pressurized room air. (16) The authors found HBO2 therapy produced similar improvements in outcomes such as gross motor function and activities of daily living in both groups.

Cancer Treatment

During the 2007 update, the literature review revealed additional indications utilizing HBO2 therapy. In a randomized controlled trial (RCT) of 32 patients, Heys and colleagues found no increase in five-year survival in patients treated with HBO2 prior to chemotherapy for locally advanced breast carcinoma to increase tumor vascularity. (17) This approach is being studied since animal models have suggested that HBO2 increases tumor vascularity and thus may make chemotherapy more effective. In a Cochrane review, Bennett and colleagues concluded HBO2 given with radiotherapy may be useful in tumor control; however, the authors expressed caution since significant adverse effects were common with HBO2 and indicated further study would be useful. (18, 19)

Delayed-Onset Muscle Soreness

In another Cochrane review, Bennett and colleagues concluded available evidence is insufficient to demonstrate beneficial outcomes with HBO2 for delayed-onset muscle soreness and closed soft tissue injury. (20) It was noted HBO2 possibly even increases pain initially and further studies are needed.

Adjunct to Coronary Interventions

In an RCT of 64 patients, Alex and colleagues concluded both neuropsychometric dysfunction and inflammatory response can be reduced post-cardiopulmonary bypass when HBO2 pretreatment is given. (21) However, the authors noted additional studies were needed to evaluate HBO2 for this indication. Therefore the experimental, investigational and unproven statement on acute coronary syndromes was modified to specify “as an adjunct to coronary interventions, including but not limited to percutaneous coronary interventions and cardiopulmonary bypass”.

Stroke and Cerebrovascular Disease

In a systematic review, Carson and colleagues concluded current available evidence does not demonstrate any benefit with the use of HBO2 therapy for the treatment of stroke. (22) The authors noted it is undetermined whether there are any benefits with HBO2 therapy that would outweigh potential harms and further study is required. In a non-randomized, controlled trial of 26 patients treated with or without HBO2 for symptomatic cerebrovascular disease, Vila and colleagues concluded HBO2 therapy improved neurologic outcomes for up to six-months. (23) However, the authors noted further study in larger patient groups is needed.

Radiation Tissue Injury

In another systematic review, Bennett and colleagues concluded that there was “some evidence that HBO2 improves the probability of healing in radiation proctitis and following hemimandibulectomy and reconstruction of the mandible; improves the probability of achieving mucosal coverage and the restoration of bony continuity with ORN (osteoradionecrosis); prevents the development of ORN following tooth extraction from a radiation field; and reduces the risk of wound dehiscence following grafts and flaps in the head and neck”. (24) They concluded that there was no benefit using HBO2 in important clinical outcomes with radiation brachial plexus lesions or cerebral tissue injury. No data was reported from randomized trials for other manifestations of late radiation tissue injury. Given the small size of many of these trials, the extended time periods of reporting, and the poor methodological quality of some studies, no changes were made in the coverage position.

Actinic Skin Damage

One published article discussed use of HBO2 therapy in combination with photosensitization and iron to treat actinic skin damage or AK. Al-Walili and colleagues discuss the advantages photodynamic therapy as the new approach to treatment of malignant tumors in addition to the beneficial effects of HBO2 in various modalities of cancer interventions. No data was reported from randomized trials for treatment of AK. (25) The authors noted the possibility of combining HBO2, iron, light, and local photosensitizers to overcome skin tumors deserve extensive laboratory and clinical research work.

Various Other Indications

The March 2003 Information Paper, produced by Alberta Heritage Foundation for Medical Research (AHFMR), Alberta, Canada government sponsored research programs, reviewed recent findings on evidence for the effectiveness of HBO2 therapy as a Health Technology Assessment. (26) The AHEMR conclusions are as follows.

  • “There is support for use of HBO2 in for the following conditions: Decompression sickness, air and gas embolism, and gas gangrene.”
  • “There is conditional support for use of HBO2 in: Carbon monoxide poisoning, osteoradionecrosis, diabetic wounds, necrotizing soft tissue infections.”
  • “There is no consensus on support for use of HBO2 in: Osteomyelitis, thermal burns, soft tissue radionecrosis, compromised skin grafts and flaps, dental implants following radiotherapy, retinal artery occlusion.”
  • “Use of HBO2 is not supported for: Crush injury, non-diabetic wounds, MS, CP, or for a large number of conditions, including but not limited to:  decubitus ulcers, necrotizing arachnidism, actinomycosis, cardiovascular conditions, Bell’s palsy, cluster or migraine headaches, Legg-Calve-Perthes disease, sudden deafness and acoustic trauma, Crohn’s disease, osteoporosis, cancer cyanide poisoning, head trauma, cerebral edema, acquired brain injury, cognitive impairment, senile dementia, glaucoma, keratoendotheliosis, HIV infection, anemia from exceptional blood loss, insulin-dependent diabetes mellitus, facial neuritis, arthritis, spinal injuries, and non-union of fractures.”

Autism Spectrum Disorders

In some studies, cerebral hypoperfusion has been correlated with repetitive, self-stimulatory, and stereotypical behaviors, and impairments in communication, sensory perception, and social interaction. HBO2 therapy has been used with some clinical success in several cerebral hypoperfusion conditions. Several studies on the use of HBO2 therapy, and HBO2 therapy in combination with chelation, in autistic children are currently underway. (27, 28, 29) In 2007, Rossignol et al. conducted a prospective study of 18 children with autism, ages 3-16 years, who were given 40 HBO2 therapy sessions of 45 minutes each, either at 1.5 atmospheres (atm) and 100% oxygen, or at 1.3 atm and 24% oxygen. (30) Although some of the results did appear to be positive, the authors concluded that, since this was an open-label study, definitive statements regarding the efficacy of HBO2 therapy for the treatment of autism must await results from double-blind, controlled trials.

Therefore, there is a lack of scientific evidence from which conclusions can be made concerning the safety and efficacy of utilizing HBO2 therapy for various other indications mentioned as clinical conditions and not a labeled indication by the FDA nor listed on the guidelines from UHMS, (31) such as:

  • AK; OR
  • Avascular necrosis; OR
  • Arterial peripheral insufficiency, acute; OR
  • ASD; OR
  • Bone grafts; OR
  • Carbon tetrachloride poisoning, acute; OR
  • CVA, acute thrombotic or embolic, acute; OR
  • Fracture healing; OR
  • Head and spinal cord injury, traumatic; OR
  • Hydrogen sulfide poisoning; OR
  • Intra-abdominal abscesses; OR
  • Lepromatous leprosy; OR
  • LD; OR
  • Meningitis; OR
  • MS; OR
  • MI, acute; OR
  • Pseudomembranous colitis, antimicrobial agent-induced colitis; OR
  • Pyoderma gangrenosum; OR
  • Retinal artery insufficiency, acute within the first 24 hours of diagnosis;
  • OR Radiation-myelitis, -cystitis, -enteritis, -proctitis; OR
  • Retinopathy, as an adjunct to scleral buckling procedure in patients with sickle cell peripheral retinopathy and retinal detachment; OR
  • SCC and/or hematuria; OR
  • Sudden deafness.

Further research with randomized, controlled, clinical trials is required to determine achievable outcomes outside the experimental, investigational and unproven setting.

Topical HBO2 (THBO2)

Due to the different methods of delivery, topical and systemic HBO2 are two distinct technologies. Outcomes associated with systemic HBO2 therapy cannot be duplicated by topical therapy. There is minimal published literature regarding THBO2 therapy. In 1984, Heng and colleagues published one controlled study of THBO2 therapy in six patients with 27 ulcers compared to no treatment in five patients with ten ulcers. (32) Although a greater improvement was noted in the treated group, the results were calculated according to the number of ulcers rather than based on individual patients. Leslie and colleagues reported on a trial that randomized 18 patients with diabetic foot ulcers to receive either THBO2 therapy plus standard wound care or standard wound care alone. (33) Changes in ulcer size and depth did not differ between the two groups. Other studies consist of anecdotal reports or uncontrolled case series. (34)       

2009 Update

A search of peer reviewed literature through October 2009 identified no new clinical trial publications or any additional information that would change the coverage position of this medical policy. Reports of uncontrolled studies, some from outside the United States, are reporting preliminary results for use of HBO2 in other conditions such as postoperative ileus and acute pancreatitis. (35, 36)

2013 Update

Since the original release of this policy, it has been updated regularly with peer reviewed literature searches, most recently for the period of July 2011 through February 2013. The following is a summary of the key literature to date.

Chronic Wounds

An updated Cochrane review of RCTs on HBO2 treatment for chronic wounds was published by Kranke and colleagues in 2012. (37) The authors identified 9 RCTs with a total of 471 participants that compared the effect of HBO2 on chronic wound healing compared to an alternative treatment approach that did not use HBO2. Eight of the 9 trials included in the review evaluated HBO2 therapy in patients with diabetes. The remaining trial addressed HBO2 for patients with venous ulcers; that study had only 16 participants and the comparator treatment was not specified. In a pooled analysis of data from 3 trials, a significantly higher proportion of ulcers had healed at the end of the treatment period (6 weeks) in the group receiving HBO2 compared to the group not receiving HBO2 (RR [risk ratio]: 5.20: 95% CI [confidence interval]: 1.25 to 21.7). Pooled analyses, however, did not find significant differences between groups in the proportion of ulcers healed in the HBO2 versus non-HBO2-treated groups at 6 months (2 trials) or 12 months (3 trials). There were insufficient data to conduct pooled analyses of studies evaluating HBO2 for treating patients with chronic wounds who did not have diabetes. The most recently published trial conducted with diabetic patients was double-blind and included 75 diabetic patients with chronic wounds who had failed at least 2 months of treatment at a diabetic foot clinic. (38) After 12 months, the healing rate was 61% in the HBO2 group and 27% in the sham hyperbaric group; this difference was statistically significant, p=0.009.

Based on the above evidence, HBO2 therapy for chronic severe diabetic ulcers remains medically necessary, and HBO2 treatment for other types of chronic wounds is considered experimental, investigational and unproven.

Acute Surgical and Traumatic Wounds

In 2011, a Cochrane review of RCTs on HBO2 therapy for acute wounds (e.g., surgical wounds, lacerations, traumatic wounds, and animal bites) was published by Eskes and colleagues. (39) To be included, studies needed to compare HBO2 with a different intervention or compare 2 HBO2 regimens; in addition, studies needed to objectively measure wound healing. A total of 7 potentially relevant studies were identified; 3 of these met the review’s inclusion criteria. The 3 studies ranged in size from 36 to 135 participants. Due to differences among studies in terms of patient population, comparison intervention, outcome measurement, etc., study results could not be pooled. In addition, investigators identified biases in the studies such as insufficient reporting of randomization procedures and selective reporting of outcome data. Findings of individual studies were mixed. For example, one study found a significantly higher rate of complete wound healing with HBO2 compared to sham HBO2 treatment, and another study did not find a significant difference in complete healing rates between HBO2 therapy and dexamethasone or heparin treatment. The authors concluded that there is insufficient high-quality data on the effect of HBO2 therapy on treatment of acute wounds.

Carbon Monoxide Poisoning

A 2011 Cochrane review of 7 RCTs concluded that the available evidence is insufficient to determine whether adverse neurologic outcomes in patients with carbon monoxide poisoning are reduced with HBO2 therapy. (40) In 2008, the American College of Emergency Physicians published a clinical policy on critical issues in carbon monoxide poisoning. (41) Their literature review indicated there was only Level C evidence (preliminary, inconclusive, or conflicting evidence) for treatment of acute carbon monoxide poisoning. The 2007 Undersea and Hyperbaric Medical Society (UHMS), however, list carbon monoxide poisoning as an indication for HBO therapy. (31)

Two blinded randomized trials were discussed in both the Cochrane and American College of Emergency Physicians reviews. One is a study by Scheinkestel and colleagues, a double-blind, RCT comparing HBO2 to normobaric oxygen in patients with carbon monoxide poisoning. (42) The authors reported that HBO2 therapy did not benefit patient outcomes of neuropsychologic performance when HBO2 therapy was completed and at 1-month follow-up. This study was limited, however, by a high rate (46%) of patients who were lost to follow-up. Moreover, the trial has been criticized for administrating 100% normobaric oxygen for at least 72 hours between treatments, which has been called a toxic dose of oxygen. (43) The critiques also mention that there was an unusually high rate of neurologic sequelae after the treatment period, which could be due in part to the high dose of oxygen and/or the high rate of cognitive dysfunction in the study population (69% were poisoned by carbon monoxide through suicide attempts).

The other blinded trial by Weaver and colleagues also compared HBO2 and normobaric oxygen (O2). (44) Patients received either 3 sessions of HBO2 or 1 session of normobaric O2 plus 2 sessions of exposure to normobaric room air. The primary outcome was the rate of cognitive sequelae at 6 weeks. Cognitive function was assessed by a battery of neuropsychological tests. At the 6-week follow-up, the intention-to-treat analysis found that 19 of 76 (25.0%) in the HBO2 group and 35 of 76 (46.1%) in the control group had cognitive sequelae; the difference was statistically significant, p=0.007. There was a high rate of follow-up at 6 weeks, 147 of 152 (97%) of randomized patients. Enrollment in the study was stopped early because an interim analysis found HBO2 to be effective. A follow-up study, that included 147 patients from the randomized trial and 75 who had been eligible for the trial but had not enrolled, was published in 2007. (45) Of the group treated with HBO2 (n=75), cognitive sequelae were identified in 10 of 58 (17%) at 6 months and 9 of 62 (14%) at 12 months. Of the group not treated with HBO2 (n=163), 44 of 146 (30%) at 6 months and 27 of 149 (18%) at 12 months had cognitive sequelae. (The follow-up rate was higher at 12 months because the investigators received additional funding for data collection). Thus, in light of the clinical studies, including the limitations of trials noted above, the use of HBO2 therapy for acute carbon monoxide poisoning remains medically necessary.

Radionecrosis and Osteoradionecrosis

A 2008 Cochrane review by Esposito et al. reviewed the use of HBO2 therapy in patients requiring dental implants. (46) The authors identified 1 randomized trial involving 26 patients. The authors concluded that despite the limited amount of clinical research available, it appears that HBO2 therapy in irradiated patients requiring dental implants may not offer any appreciable clinical benefits. They indicate that there is a need for more RCTs to ascertain the effectiveness of HBO2 in irradiated patients requiring dental implants.

In 2012, Bennett and colleagues published a Cochrane review on HBO2 therapy for late radiation tissue injury. (47) This was an update to their 2005 review (48). The authors identified 11 RCTs; there was variability among trials and study findings were not pooled for the primary outcomes of survival, complete resolution of necrosis or tissue damage, and improvement in a late effects symptom scale. In a pooled analysis of 3 studies, a significantly higher proportion of patients with osteoradionecrosis achieved complete mucosal cover after HBO2 treatment compared to control (RR: 1.30, 95% CI: 1.09 to 1.55). From their review of the literature, the authors concluded that data from small trials “suggest that for people with LRTI (Late Radiation Tissue Injury) affecting the head, neck, anus, and rectum, [HBO2] is associated with improved outcome. HBO [HBO2] also appears to reduce the chance of ORN [osteoradionecrosis] following tooth extraction in an irradiated field. There was no such evidence of any important clinical effect on neurological tissues. The application of HBOT [HBO2 therapy] to selected patients and tissues may be justified.”

In 2012, Shao and colleagues in China published an RCT including 36 patients who had undergone radiotherapy for pelvic malignancies and had radiation-induced hemorrhagic cystitis. (49) Patients were randomized to treatment with hyaluronic acid (n=16) or HBO2 (n=20). The hyaluronic acid group received weekly injections for the first month and monthly injections for the following 2 months. HBO2 treatment consisted of 30-minute sessions daily for one month. All patients completed the study. There were no statistically significant differences in outcomes e.g., pain or voids per day 6, 12, or 18 months after treatment. For example, at 12 months after treatment, the number of voids per day was 8.9 in the hyaluronic acid group and 9.7 in the HBO2 group, p>0.05. The study may have been underpowered to detect statistically significant differences between groups.

In summary, given the longstanding use of this technology, the existing literature base and the Cochrane reviews noted above, the use of HBO2 therapy for treatment of soft tissue and bone radiation necrosis and for pre- and post-treatment of dental surgery (non-implant-related) in an irradiated jaw remains medically necessary.

Osteomyelitis

No prospective clinical trials on chronic refractory osteomyelitis or acute refractory osteomyelitis were identified in updated searches. The justification for the use of HBO2 in chronic osteomyelitis has been primarily based on case series. Among the larger case series, Maynor and colleagues reviewed the records of all patients with chronic osteomyelitis of the tibia seen at one institution. (50) Follow-up data were available on 34 patients who had received a mean of 35 adjunctive HBO2 treatments (range, 6 to 99). Of the 26 patients with at least 2 years of follow-up after treatment, 21 (81%) remained drainage-free. Twelve of 15 (80%) with follow-up data at 60 months had remained drainage-free. A study by Davis and colleagues reviewed outcomes for 38 patients with chronic refractory osteomyelitis treated at another U.S. institution. (51) Patients received HBO2 treatment until the bone was fully recovered with healthy vascular tissue; this resulted in a mean of 48 daily HBO2 treatments (range, 8 to 103). After a mean post-treatment follow-up of 34 months, 34 of 38 (89%) patients remained clinically free of infection (i.e., drainage-free and no tenderness, pain, or cellulitis). Success rates from several smaller case series, all conducted in Taiwan, are 12 of 13 (92%) patients, 11 of 14 (79%) patients, and 13 of 15 (86%) patients. (52, 53, 54) Given the high percentage of refractory patients in these series who had successful outcomes, the use of HBO2 therapy for chronic refractory osteomyelitis remains medically necessary. HBO2 treatment for acute osteomyelitis refractory to medical treatment is considered experimental, investigational and unproven.

Compromised Skin Grafts and Flaps

In 2006, Friedman and colleagues published a systematic review of literature on use of HBO2 for treating skin flaps and grafts. (55) No RCTs were found. The authors identified 2 retrospective case series on use of HBO2 for clinically compromised skin grafts and flaps. The series had sample sizes of 65 and 26, respectively; both were published in the 1980s based on treatment provided in the 1970s and 1980s. Given the limited published data and lack of recent data, this indication remains experimental, investigational and unproven.

Necrotizing Soft Tissue Infections

A 2005 systematic review by Jallali and colleagues evaluated the literature on HBO2 as adjunctive therapy for necrotizing fasciitis. (56) They did not identify any RCTs. There were only a few retrospective studies with small sample sizes and findings were inconsistent. The authors concluded that more robust evidence is needed before widespread use of HBO2 is recommended. A 2009 retrospective cohort study compared outcomes in 48 patients at 1 center who received adjunctive HBO2 for necrotizing soft issue infections to those in 30 patients at a different center who did not receive HBO2. (57) There was not a significant difference in the mortality rate between the 2 groups; this was 4 of 48 (8%) in the HBO2 group and 4 of 30 (13%) in the non-HBO2 group (p=0.48). The median number of days in the intensive care unit and the median number of days in the hospital also did not differ significantly. There was a higher median number of debridement procedures per person in the HBO2 group, 3.0 compared to 2.0 in the non-HBO group (p=0.03). Despite the available evidence just cited, HBO2 therapy for necrotizing soft tissue infections remains medically necessary as cited earlier from reviews by the AHFMR’s March 2003 Information Paper. (26)

Refractory Mycoses

No additional clinical trials on refractory mycoses (mucormycosis, actinomycosis, conidiobolus coronato) and cerebral edema were found. Therefore, the coverage remains unchanged.

Acute Peripheral Arterial Insufficiency

No additional clinical trials on the treatment of acute peripheral arterial insufficiency with HBO2 were found. Therefore, the coverage remains unchanged.

Acute Coronary Syndromes

A 2012 Cochrane review by Bennett and colleagues identified 6 trials with a total of 665 patients evaluating HBO2 for acute coronary syndrome. (58) All of the studies included patients with acute MI; one study also included individuals presenting with unstable angina. Additionally, all trials used HBO2 as an adjunct to standard care. Control interventions varied; only 1 trial described using a sham therapy to blind participants to treatment group allocation. In a pooled analysis of data from 5 trials, there was a significantly lower rate of death in patients who received HBO2 compared to a control intervention (RR: 0.58: 0.36 to 0.92). Due to variability of outcome reporting in the studies, few other pooled analyses could be conducted. A pooled analysis of data from 3 trials on improvements in left ventricular function did not find a statistically significant benefit of HBO2 treatment (RR: 0.09; 95% CI: 0.01 to 1.4). The authors noted that, although there is some evidence from small trials that HBO2 treatment is associated with a lower risk of death, larger trials with high methodologic quality are needed in order to determine which patients, if any, can be expected to derive benefit from HBO2.

In another RCT of 64 patients, Alex and colleagues concluded both neuropsychometric dysfunction and inflammatory response can be reduced postcardiopulmonary bypass when HBO2 pretreatment is given. (59) Based on the above evidence, the treatment of acute coronary syndromes with HBO2 remains experimental, investigational and unproven.

Stroke

No additional clinical trials on the treatment of acute ischemic stroke with HBO2 were found. Therefore, the coverage remains unchanged.

Bell’s Palsy (BP)

In 2012, Holland and colleagues published a Cochrane review evaluating HBO2 treatment in adults with Bell’s palsy. (60) The authors identified one RCT with 79 participants, and this study did not meet the Cochrane review methodologic standards because the outcome assessor was not blinded to treatment allocation. Due to the publication of the Cochrane review and the finding of insufficient evidence, Bell’s palsy was added to the experimental, investigational and unproven coverage listing.

Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)

In 2011, the UHMS added ISSNHL as an approved indication for HBO2 therapy. (61)

A Cochrane review on HBO2 for ISSNHL and tinnitus identified 7 trials with a total of 392 participants. (62) The literature search by the author was last assessed as up-to-date in July 2009. All trials included patients with ISSNHL with and/or without tinnitus; 2 trials also included patients with tinnitus in the absence of ISSNHL. Randomization procedures were only described in one study, and only one study stated they blinded participants to treatment group assignment using sham therapy. Six of the studies included time-based entry criteria for hearing loss and/or tinnitus; this was 48 hours in 3 studies, 2 weeks in 2 studies (for acute presentation) and 6 months in 1 study. The dose of O2 per treatment session and the treatment protocols varied among studies e.g., the total number of treatment sessions varied from 10 to 25. All trials reported on change in hearing following treatment; but specific outcomes varied. Two trials reported the proportion of participants with greater than 50% return of hearing at the end of therapy. A pooled analysis of these studies did not find a statistically significant difference in outcomes between the HBO2 and control groups (RR: 1.53, 95% CI: 0.86 to 2.78). In contrast, a pooled analysis of 2 trials reporting the proportion of participants with greater than 25% return of hearing at the end of therapy found a significantly higher rate of improvement after HBO2 compared to a control intervention (RR: 1.39: 95% CI: 1.05 to 1.84). Moreover, a pooled analysis of 4 trials found a significantly greater mean improvement in hearing over all frequencies with HBO2 compared to control (mean difference: 15.6 decibels (dB); 95% CI: 1.5 to 29.8). The authors stated that, due to methodologic shortcomings of the trials and the modest number of patients, results of the meta-analysis should be interpreted cautiously; they did not recommend use of HBO2 for treating ISSNHL.

In 2012, Suzuki and colleagues in Japan published findings of a non-RCT in 276 consecutive patients with ISSNHL. (63) All patients had been treated with intravenous hydrocortisone. In addition, 174 patients underwent HBO2 treatment and 102 patients received intratympanic dexamethasone injection. There was no significant difference in most outcomes e.g., cure rate, marked recovery rate and hearing gain (dB) between the groups of patients who received HBO2 treatment compared to dexamethasone injections. However, at the p<0.05 level, the recovery rate (complete, good, or fair recovery) was significantly higher in the dexamethasone injection group than the HBO2 group (79.4% vs. 68%, respectively p=0.048). Limitations of this study were that individuals were not randomized to treatment group, and the authors did not adjust the p value to account for multiple outcome variables.

Based on the UHMS adding ISSNHL as an approved indication and the report within the literature that hearing has improved, and some studies showing a significant greater mean improvement of hearing in all frequencies, HBO2 would be appropriate for the treatment of ISSNHL.

Amyotrophic Lateral Sclerosis (ALS)

In the update searches, no randomized trials were found evaluating HBO2 for treatment of ALS. Thus, coverage for ALS remains unchanged.

In Vitro Fertilization (IVF)

No additional clinical trials were found evaluating HBO2 for treatment of IVF. Thus, coverage for IVF remains unchanged.

Cerebral Palsy (CP)

In the update searches, no clinical trials were found evaluating HBO2 for treatment of CP. Thus, coverage for CP remains unchanged.

Cancer Treatment

No additional clinical trials were found evaluating HBO2 for treatment of locally advanced breast carcinoma. Therefore, coverage for tumor sensitization for cancer treatments, including radiotherapy or chemotherapy, remains unchanged.

Delayed-onset Muscle Soreness

In the update searches, no clinical trials were found evaluating HBO2 for treatment of delayed-onset muscle soreness. Thus, coverage for this indication remains unchanged.

Autism Spectrum Disorders

A 2012 systematic review of evidence on HBO2 therapy for treatment of children with autism identified 2 RCTs with a total of 89 participants. (64) One of the 2 RCTs found better outcomes after HBO2 compared to placebo treatment, and the other did not find significant differences in outcomes. The author concluded that additional sham-controlled trials with rigorous methodology are needed in order to draw conclusions about the efficacy of HBO2 for treating autism. A 2012 review article also concluded that, although studies to date suggest that HBO2 is safe and potentially effective, additional studies are warranted. (65) In particular, it was recommended that future studies use standardized behavioral measurement tools and also assess physiological biomarkers.

One of the RCTs was by Rossignol and colleagues. (66) This double-blind trial included 62 children, ages 2-7 years, who met Diagnostic and Statistical Manual of mental Disorders (DSM)-IV criteria for autistic disorder. The active treatment was hyperbaric treatment at 1.3 atmospheres (atm) and 24% oxygen in a hyperbaric chamber. (This regimen differs from standard HBO2 treatment which uses 100% oxygen and a pressure of at least 1.4 atm.) The other group received a sham treatment consisting of 1.03 atm and ambient air (21% oxygen). Both groups received 40 sessions of active or sham treatment lasting 60 minutes each over a period of 4 weeks. The equipment, procedures, etc. in the 2 groups were as similar as possible to maintain blinding. The investigators, participants, parents, and clinic staff were blinded to treatment group. Only the hyperbaric technician, who had no role in outcome assessment, was aware of group assignment. After completion of the 4-week study, families with children in the control group were offered the active intervention. When asked at the end of the study, there was no significant difference in the ability of parents to correctly guess the group assignment of their child.

The outcomes were change compared to baseline after 4 weeks on the following scales: Aberrant Behavior Checklist (ABC) total score and 5 subscales: Autism Treatment Evaluation Checklist (ATEC) total score and 4 subscales; and Clinical Global Impression-Improvement (CGI) overall functioning score and 18 subscales. P values of <0.05 were considered statistically significant; there was no adjustment for multiple comparisons. The analysis included all children who completed at least one complete session. Of the 33 children assigned to active treatment, 30 were included in the analysis, and 29 completed all 40 treatments. Of the 29 children assigned to the control treatment, 26 completed all 40 sessions and were included in the analysis.

There was no significant between-group improvement on the ABC total score, any of the ABC subscales, or on the ATEC total score. Compared to the control group, the treatment group had a significant improvement in 1 of 4 subscales of the ATEC, the sensory/cognitive awareness subscale. The change from baseline on this subscale was a mean of 16.5 in the treatment group and a mean of 5.4 in the control group, a difference of 11.1 (p=0.037). (Note: due to an administrative error, baseline ATEC was not collected at one site, and thus data were not available for 23 children in the treatment group and 21 children in the control group). On the physician-rated CGI total score, 9/30 (30%) children in the treatment group had a score of 1 (very much improved) or 2 (much improved) compared to 2/26 (8%) in the control group (p=0.047). On the parental-rated CGI total score, 9/30 (30%) children in the treatment group had a score of 1 or 2 compared to 4/26 (15%) in the control group (p=0.22, not statistically significant). (The exact numbers receiving scores of 1 vs. 2 were not reported.) Change in mean CGI scores were also reported, but this may be a less appropriate way to analyze these data. Among the parental-rated CGI subscales, significantly more children were rated as improved in the treatment group compared to control on 2 out of 18 subscales, receptive language (p=0.017) and eye contact (p=0.032).

A key limitation of this study was that the authors reported only outcomes at 4 weeks, directly after completion of the intervention. It is not known whether there are any long-term effects. Additional follow-up data cannot be obtained because members of the control group crossed over to the intervention after 4 weeks. Other limitations include lack of adjustment for multiple comparisons and unclear clinical significance of the statistically significant outcomes. The UHMS issued a position paper after publication of the Rossignol et al. study stating that they still did not recommend routine treatment of autism with HBO2. (67) Based on limitations of the Rossignol and colleagues RCT and the lack of other controlled studies, autism was added to the policy as an experimental, investigational and unproven indication for HBO2.

Radiotherapy Adverse Effects

In 2010, Spiegelberg and colleagues conducted a systematic review of studies on HBO2 therapy to prevent or treat radiotherapy-induced head and neck injuries associated with treatment of malignant tumors. (68) The authors identified 20 studies. Eight of the studies included control groups; their sample sizes ranged from 19 to 78 individuals. Four (50%) of the studies with a control group concluded that HBO2 was effective, and the other 4 did not conclude that the HBO2 was effective. The authors noted a paucity of RCTs but did not state the number of RCTs that they identified in their review.

A study by Teguh and colleagues published in 2009 included 17 patients with oropharyngeal or nasopharyngeal cancer who were treated with radiation therapy; the study was conducted in The Netherlands. (69) HBO2 therapy was used to prevent adverse events following radiotherapy. Eight patients were randomly assigned to receive 30 sessions of HBO2, beginning within 2 days of completing radiation therapy, and 9 patients received no additional treatment. All patients were included in the analysis. Quality-of-life outcomes were assessed, and the primary outcome was specified as xerostomia at 1 year. Quality-of-life measures did not differ significantly between groups in the acute phase (first 3 months). For example, 1 month after treatment, the mean visual analog scale (VAS) score for xerostomia (0-to-10 scale) was 5 in the HBO2 group and 6 in the control group. However, at 1 year, there was a statistically significant difference between groups; the mean VAS score for xerostomia was 4 in the HBO2 group and 7 in the control group (p=0.002). Also at 1 year, the mean quality-of-life score for swallowing (0-to-100 scale) was 7 in the HBO2 group and 40 in the control group (p=0.0001). The study is limited by the small sample size and the wide fluctuation over the follow-up period in quality-of-life ratings.

In 2010, Gothard and colleagues in the U.K. published findings of a RCT using HBO2 therapy to treat arm lymphedema occurring after radiotherapy for cancer. (70) Fifty-eight patients with arm lymphedema (at least 15% increase in arm volume) following cancer treatment were randomized in a 2:1 ratio to receive HBO2 (n=38) or usual care without HBO2 (n=20). Fifty-three patients had baseline assessments and 46/58 (79%) had 12-month assessments. At the 12-month follow-up, there was not a statistically significant difference in the change from baseline in arm volume. The median change from baseline was -2.9% in the treatment group and -0.3% in the control group. The study protocol defined response as at least an 8% reduction in arm volume relative to the contralateral arm. According to this definition, 9 of 30 (30%) of patients in the HBO2 group were considered responders compared with 3 of 16 (19%) in the control group; the difference between groups was not statistically significant. Other outcomes, e.g., quality-of-life scores on the Short-Form (SF)-36, were similar between groups.

Due to the limited data, use of HBO2 to treat arm lymphedema or radiation-induced injury in the head and neck after radiotherapy, as well as early use of HBO2 after radiation therapy to reduce side effects is considered experimental, investigational and unproven.

Idiopathic femoral neck necrosis

A double-blind RCT that evaluated HBO2 therapy to treat femoral head necrosis was published in 2010 by Camporesi and colleagues. (71) The study included 20 adult patients with idiopathic unilateral femoral head necrosis. Patients received 30 treatments over 6 weeks with either HBO2 at 2.5 ATA (n=10) or a sham treatment consisting of hyperbaric air (n=10). The mean severity of pain on a 0-to-10 scale was significantly lower in the HBO2 group than the control group after 30 sessions (p<0.001) but not after 10 or 20 sessions. (The article did not report exact pain scores.) Several range-of-motion outcomes were also reported; degrees were the unit of measurement. At the end of the initial treatment period, extension, abduction and adduction, but not flexion, were significantly greater in the HBO2 group compared to the control group. Longer-term comparative data were not available because the control group was offered HBO2 at the end of the initial 6-week treatment period. This single, small short-term RCT represents insufficient data on which to draw conclusions about the efficacy of HBO2 for treating femoral head necrosis.

Migraine

A Cochrane review by Bennett and colleagues identified RCTs that evaluated the effectiveness of systemic HBO therapy for preventing or treating migraine headache compared to another treatment or a sham control. (72) In their search of the literature through May 2008, 5 trials with a total of 103 patients were identified that addressed treatment of acute migraine with HBO2. A pooled analysis of 3 trials (total of 43 patients) found a statistically significant increase in the proportion of patients with substantial relief of migraine within 45 minutes of HBO2 treatment (RR: 5.97, 95% CI: 1.46-24.38, p=0.001). No other pooled analyses were conducted due to variability in the outcomes reported in the trials. The meta-analysis does not report data on treatment effectiveness beyond the immediate post-treatment period, and the methodologic quality of trials was moderate to low, e.g., randomization was not well-described in any trial. Based on the above limitations of the meta-analysis, the use of HBO2, to treat migraine, remains experimental, investigational and unproven.

Topical HBO2 (THBO2)

In the update searches, no additional peer reviewed literature was found evaluating THBO2 for treatment of covered indications in lieu of systemic HBO2 therapy. Thus, coverage for the use of THBO2 remains unchanged.

Ongoing Clinical Trials

RCTs are underway that are evaluating HBO2 therapy for indications now considered experimental, investigational and unproven include the following:

  • HBOs therapy in distal radius fractures: Can it shorten recovery time and increase fracture healing? (NCT01365780): (73) This non-blinded RCT is comparing HBO2 to usual care given to patients who undergo surgery for distal radius fractures. Outcomes include microcirculation and pain level. The study is sponsored by RWTH Aachen University in Germany. The study is not yet recruiting patents.
  • Two ongoing RCTs were identified that are studying HBO2 for treatment of postconcussive symptoms after mild traumatic brain injury in a military population (NCT01220713 and NCT01306968): (74, 75) Both are comparing treatment with HBO2 to sham treatment, and evaluating change in symptoms. NCT01220713 is sponsored by the U.S. Naval Medical Center and Portsmouth Hunter McGuire Veteran Affairs Medical Center. It includes patients who experienced a blast event during deployment. NCT01306968 is sponsored by the U.S. Army Medical Research and Materiel Command and is including individuals who experienced a wider range of traumatic events during deployment.

Practice Guidelines and Position Statements

Undersea and Hyperbaric Medical Society (UHMS)

In 2008, the UHMS updated their list of indications considered appropriate for HBO2 therapy. (31) 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); OR
  • Acute thermal burn injury.

In October 2011, the UHMS Executive Board approved ISSNH as an additional indication. (76) According to treatment guidelines, patients with moderate to profound ISSNHL who present within 14 days of symptom onset should be considered for HBO2 treatment.

In 2012, the American Academy of Otolaryngology-Head and Neck Surgery (AAOHNS) published a clinical guideline on treatment of sudden hearing loss. (77, 78) The guideline includes a statement that HBO2 may be considered a treatment option for patients who present within 3 months of a diagnosis of ISSNH. The document states, “Although HBOT is not widely available in the United States and is not recognized by many U.S. clinicians as an intervention for ISSNHL, the panel felt that the level of evidence for hearing improvement, albeit modest and imprecise, was sufficient to promote greater awareness of HBOT as an intervention for [this condition]”.

Summary

Based on the available evidence, ISSNH was changed in 2013 to medically necessary indications for HBO2 therapy. However, despite the limited or lack of published evidence HBO2 treatment  Bell’s palsy, idiopathic femoral neck necrosis, lymphedema of the arm, acute osteomyelitis, radiation-induced injury to head and neck, reduction of adverse effects at early treatment of radiation therapy, and acute surgical and traumatic wounds were added to the policy as experimental, investigational and unproven.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

008.49, 030.0, 039, 039.0, 039.1, 039.2, 039.3, 039.4, 039.8, 039.9, 040.0, 088.81, 090.0, 93.95, 93.96, 095.5, 111, 111.0, 111.1, 111.2, 111.3, 111.8, 111.9, 112, 112.0, 112.1, 112.2, 112.3, 117.9, 282.62, 285.1, 299.00, 299.01, 299.10, 299.11, 299.80, 299.81, 299.90, 299.11, 312.00, 312.01, 312.02, 312.03, 312.10, 312.11, 312.12, 312.13, 312.20, 312.21, 312.22, 312.23, 312.30, 312.34, 312.35, 312.4, 312.81, 312.82, 312.89, 312.9, 313.0, 313.1, 313.21, 313.22, 313.23, 313.3, 313.81, 313.82, 313.83, 313.89, 313.9, 315.31, 315.32, 315.39, 315.4, 315.5, 315.8, 315.9, 317, 318.0, 318.1, 318.2, 319, 322.9, 323.9, 324.0, 340, 348.5, 348.8, 351.0, 362.10, 376.03, 388.2, 389.10, 389.11, 389.12, 389.13, 389.14, 389.15, 389.16, 389.17, 389.18, 410.9, 436, 444.9, 447.2, 454.0, 457.0, 457.1, 457.2, 457.8, 457.9, 459.0, 459.9, 526.4, 526.89, 558.1, 560.1, 560.8, 560.9, 564.8, 567.2, 569.49, 577.0, 593.81, 595.82, 674.30, 682, 682.0, 682.1, 682.2, 682.3, 682.4, 682.5, 682.6, 682.7, 682.8, 682.9, 686, 686.0, 686.00, 686.01, 686.09, 686.1, 686.8, 686.9, 707.0, 728.86, 730, 730.0, 730.00, 730.01, 730.02, 730.03, 730.04, 730.05, 730.06, 730.07, 730.08, 730.09, 730.1, 730.10, 730.11, 730.12, 730.13, 730.14, 730.15, 730.16, 730.17, 730.18, 730.19, 730.2, 730.20, 730.21, 730.22, 730.23, 730.24, 730.25, 730.26, 730.27, 730.28, 730.29, 730.8, 730.80, 730.81, 730.82, 730.83, 730.84, 730.85, 730.86, 730.87, 730.88, 730.89, 733.42, 759.83, 767.0, 767.8, 767.9, 783.40, 783.42, 785.4, 803.00, 839.9, 854.00, 876.0, 876.1, 879.8, 878.9, 909.2, 925, 925.1, 925.2, 926, 926.0, 926.1, 926.11, 926.12, 926.19, 926.8, 926.9, 927, 927.0, 927.00, 927.01, 927.02, 927.03, 927.09, 927.1, 927.10, 927.11, 927.2, 927.20, 927.21, 927.3, 927.8, 927.9, 928, 928.0, 928.00, 928.01, 928.1, 928.10, 928.11, 928.2, 928.20, 928.21, 928.3, 928.8, 928.9, 929, 929.0, 929.9, 948, 948.0, 948.1, 948.10, 948.11, 948.2, 948.20, 948.21, 948.3, 948.30, 948.31, 948.32, 948.33, 948.4, 948.40, 948.41, 948.42, 948.43, 948.44, 948.5, 948.50, 948.51, 948.52, 948.53, 948.54, 948.55, 948.6, 948.60, 948.61, 948.62, 948.63, 948.64, 948.65, 948.66, 948.7, 948.70, 948.71, 948.72, 948.73, 948.74, 948.75, 948.76, 948.77, 948.8, 948.80, 948.81, 948.82, 948.83, 948.84, 948.85, 948.86, 948.87, 948.88, 948.9, 948.90, 948.91, 948.92, 948.93, 948.94, 948.95, 948.96, 948.97, 948.98, 948.99, 949.0, 952.9, 958.0, 958.3, 958.8, 958.90, 958.91, 958.92, 958.93, 959.01, 959.09, 986, 986.0, 987.8, 987.9, 989.0, 989.5, 990, 993.3, 996.4, 996.52, 996.55, 996.69, 996.7, 996.78, 996.79, 997.4, 998.30, 998.31, 998.32, 998.33, 998.83, 998.89, V15.3, V18.4, V19.5, V40, V45.89, V54.9

ICD-10 Codes

A04.8, A18.01, A18.03, A30.5, A42.0, A42.1, A42.2, A42.81, A42.82, A42.89, A42.9, A43.0, A43.1, A43.8, A43.9, A48.0, A50.01, A50.02, A50.03, A50.04, A50.05, A50.06, A50.07, A50.08, A50.09, A52.77, A69.20 A69.21, A69.22, A69.23, A69.29, B25.2, B36.0, B36.1, B36.2, B36.3, B36.8, B36.9, B37.0, B37.2, B37.3, B37.41, B37.42, B37.49, B37.83, B46.0, B46.1, B46.2, B46.3, B46.4, B46.5, B47.1, B47.9, B48.3, B48.8, B49, B78.1, D57.00, D57.01, D57.02, D62, E08.52, E09.52, E10.52, E11.52, E11.621, E11.622, E13.52, E13.621, E13.622, E83.2, F40.10, F48.9, F63.81, F63.89, F63.9, F64.9, F69, F70, F71, F72, F73, F78, F79, F80.0, F80.1, F80.2, F80.89, F80.9, F81.9, F82, F84.0, F84.3, F84.5, F84.8, F84.9, F88, F89, F91.0, F91.1, F91.2, F91.3, F91.8, F91.9, F93.8, F93.9, F94.0, F94.1, F94.2, F94.8, F94.9, F98.8, F98.9, G03.9, G04.90, G04.91, G06.0, G35, G37.4, G93.6, H05.021, H05.022, H05.023, H05.029, H34.10, H34.11, H34.12, H34.13, H35.00, H70.201, H70.202, H70.203, H70.209, H70.211, H70.212, H70.213, H70.219, H70.221, H70.222, H70.223, H70.229, H91.20, H91.21, H91.22, H91.23, H93.25, I21.3, I22.9, I67.89, I70.231, I70.232, I70.233, I70.234, I70.235, I70.238, I70.239, I70.241, I70.242, I70.243, I70.244, I70.245, I70.248, I70.249, I70.25, I70.331, I70.332, I70.333, I70.334, I70.335, I70.338, I70.339, I70.341, I70.342, I70.343, I70.344, I70.345, I70.348, I70.349, I70.35, I70.361, I70.362, I70.363, I70.368, I70.369, I70.431, I70.432, I70.433, I70.434, I70.435, I70.438, I70.439, I70.441, I70.442, I70.443, I70.444, I70.445, I70.448, I70.449, I70.45, I70.461, I70.462, I70.463, I70.468, I70.469, I70.531, I70.532, I70.533, I70.534, I70.535, I70.538, I70.539, I70.541, I70.542, I70.543, I70.544, I70.545, I70.548, I70.549, I70.55, I70.561, I70.562, I70.563, I70.568, I70.569, I70.631, I70.632, I70.633, I70.634, I70.635, I70.638, I70.639, I70.641, I70.642, I70.643, I70.644, I70.645, I70.648, I70.649, I70.65, I70.661, I70.662, I70.663, I70.668, I70.669, I70.731, I70.732, I70.733, I70.734, I70.735, I70.738, I70.739, I70.741, I70.742, I70.743, I70.744, I70.745, I70.748, I70.749, I70.75, I70.761, I70.762, I70.763, I70.768, I70.769, I73.01, I73.9, I74.2, I74.3, I74.4, I74.5, I74.9, I77.2, I83.001, I83.002, I83.003, I83.004, I83.005, I83.008, I83.009, I83.011, I83.012, I83.013, I83.014, I83.015, I83.018, I83.019, I83.021, I83.022, I83.023, I83.024, I83.025, I83.028, I83.029, I87.031, I87.032, I87.033, I87.039, I96, I99.9, K12.2, K50.012, K50.112, K50.812, K50.912, K51.012, K51.212, K51.312, K51.412, K51.512, K51.812, K51.912, K52.0, K56.0, K56.5, K56.60, K56.69, K56.7, K59.2, K59.8, K62.7, K62.89, K62.9, K65.0, K65.1, K65.2, K85.0, K85.1, K85.2, K85.3, K85.8, K85.9, K91.3, K91.81, K91.82, K91.83, K91.86, K91.89, L02.01, L02.11, L02.211, L02.212, L02.213, L02.214, L02.215, L02.216, L02.219, L02.31, L02.411, L02.412, L02.413, L02.414, L02.415, L02.416, L02.419, L02.511, L02.512, L02.519, L02.611, L02.612, L02.619, L02.811, L02.818, L02.91, L03.111, L03.112, L03.113, L03.114, L03.115, L03.116, L03.119, L03.121, L03.122, L03.123, L03.124, L03.125, L03.126, L03.129, L03.211, L03.212, L03.221, L03.222, L03.311, L03.312, L03.313, L03.314, L03.315, L03.316, L03.317, L03.319, L03.321, L03.322, L03.323, L03.324, L03.325, L03.326, L03.327, L03.329, L03.811, L03.818, L03.891, L03.898, L03.90, L03.91, L08.0, L08.1, L08.81, L08.82, L08.89, L08.9, L59.9, L88, L89.000, L89.001, L89.002, L89.003, L89.004, L89.009, L89.010, L89.011, L89.012, L89.013, L89.014, L89.019, L89.020, L89.021, L89.022, L89.023, L89.024, L89.029, L89.100, L89.101, L89.102, L89.103, L89.104, L89.109, L89.110, L89.111, L89.112, L89.113, L89.114, L89.119, L89.120, L89.121, L89.122, L89.123, L89.124, L89.129, L89.130, L89.131, L89.132, L89.133, L89.134, L89.139, L89.140, L89.141, L89.142, L89.143, L89.144, L89.149, L89.150, L89.151, L89.152, L89.153, L89.154, L89.159, L89.200, L89.201, L89.202, L89.203, L89.204, L89.209, L89.210, L89.211, L89.212, L89.213, L89.214, L89.219, L89.220, L89.221, L89.222, L89.223, L89.224, L89.229, L89.300, L89.301, L89.302, L89.303, L89.304, L89.309, L89.310, L89.311, L89.312, L89.313, L89.314, L89.319, L89.320, L89.321, L89.322, L89.323, L89.324, L89.329, L89.40, L89.41, L89.42, L89.43, L89.44, L89.45, L89.500, L89.501, L89.502, L89.503, L89.504, L89.509, L89.510, L89.511, L89.512, L89.513, L89.514, L89.519, L89.520, L89.521, L89.522, L89.523, L89.524, L89.529, L89.600, L89.601, L89.602, L89.603, L89.604, L89.609, L89.610, L89.611, L89.612, L89.613, L89.614, L89.619, L89.620, L89.621, L89.622, L89.623, L89.624, L89.629, L89.810, L89.811, L89.812, L89.813, L89.814, L89.819, L89.890, L89.891, L89.892, L89.893, L89.894, L89.899, L89.90, L89.91, L89.92, L89.93, L89.94, L89.95, L92.8, L97.101, L97.102, L97.103, L97.104, L97.109, L97.111, L97.112, L97.113, L97.114, L97.119, L97.121, L97.122, L97.123, L97.124, L97.129, L97.201, L97.202, L97.203, L97.204, L97.209, L97.211, L97.212, L97.213, L97.214, L97.219, L97.221, L97.222, L97.223, L97.224, L97.229, L97.301, L97.302, L97.303, L97.304, L97.309, L97.311, L97.312, L97.313, L97.314, L97.319, L97.321, L97.322, L97.323, L97.324, L97.329, L97.401, L97.402, L97.403, L97.404, L97.409, L97.411, L97.412, L97.413, L97.414, L97.419, L97.421, L97.422, L97.423, L97.424, L97.429, L97.501, L97.502, L97.503, L97.504, L97.509, L97.511, L97.512, L97.513, L97.514, L97.519, L97.521, L97.522, L97.523, L97.524, L97.529, L97.801, L97.802, L97.803, L97.804, L97.809, L97.811, L97.812, L97.813, L97.814, L97.819, L97.821, L97.822, L97.823, L97.824, L97.829, L97.901, L97.902, L97.903, L97.904, L97.909, L97.911, L97.912, L97.913, L97.914, L97.919, L97.921, L97.922, L97.923, L97.924, L97.929, L98.0, L98.3, L98.411, L98.412, L98.413, L98.414, L98.419, L98.421, L98.422, L98.423, L98.424, L98.429, L98.491, L98.492, L98.493, L98.494, L98.499, M27.2, M27.8, M46.20, M46.21, M46.22, M46.23, M46.24, M46.25, M46.26, M46.27, M46.28, M72.6, M79.A11, M79.A12, M79.A19, M79.A21, M79.A22, M79.A29, M79.A3, M79.A9, M86.00, M86.011, M86.012, M86.019, M86.021, M86.022, M86.029, M86.031, M86.032, M86.039, M86.041, M86.042, M86.049, M86.051, M86.052, M86.059, M86.061, M86.062, M86.069, M86.071, M86.072, M86.079, M86.08, M86.09, M86.10, M86.111, M86.112, M86.119, M86.121, M86.122, M86.129, M86.131, M86.132, M86.139, M86.141, M86.142, M86.149, M86.151, M86.152, M86.159, M86.161, M86.162, M86.169, M86.171, M86.172, M86.179, M86.18, M86.19, M86.20, M86.211, M86.212, M86.219, M86.221, M86.222, M86.229, M86.231, M86.232, M86.239, M86.241, M86.242, M86.249, M86.251, M86.252, M86.259, M86.261, M86.262, M86.269, M86.271, M86.272, M86.279, M86.28, M86.29, M86.30, M86.311, M86.312, M86.319, M86.321, M86.322, M86.329, M86.331, M86.332, M86.339, M86.341, M86.342, M86.349, M86.351, M86.352, M86.359, M86.361, M86.362, M86.369, M86.371, M86.372, M86.379, M86.38, M86.39, M86.40, M86.411, M86.412, M86.419, M86.421, M86.422, M86.429, M86.431, M86.432, M86.439, M86.441, M86.442, M86.449, M86.451, M86.452, M86.459, M86.461, M86.462, M86.469, M86.471, M86.472, M86.479, M86.48, M86.49, M86.50, M86.511, M86.512, M86.519, M86.521, M86.522, M86.529, M86.531, M86.532, M86.539, M86.541, M86.542, M86.549, M86.551, M86.552, M86.559, M86.561, M86.562, M86.569, M86.571, M86.572, M86.579, M86.58, M86.59, M86.60, M86.611, M86.612, M86.619, M86.621, M86.622, M86.629, M86.631, M86.632, M86.639, M86.641, M86.642, M86.649, M86.651, M86.652, M86.659, M86.661, M86.662, M86.669, M86.671, M86.672, M86.679, M86.68, M86.69, M86.8X0, M86.8X1, M86.8X2, M86.8X3, M86.8X4, M86.8X5, M86.8X6, M86.8X7, M86.8X8, M86.8X9, M86.9, M90.80, M90.811, M90.812, M90.819, M90.821, M90.822, M90.829, M90.831, M90.832, M90.839, M90.841, M90.842, M90.849, M90.851, M90.852, M90.859, M90.861, M90.862, M90.869, M90.871, M90.872, M90.879, M90.88, M90.89, M96.621, M96.622, M96.629, M96.631, M96.632, M96.639, M96.65, M96.661, M96.662, M96.669, M96.671, M96.672, M96.679, M96.69, N28.0, N30.40, N30.41, No,,, ICD10, P10.0, P10.1, P10.4, P10.8, P10.9, P11.0, P11.1, P11.2, P11.9, P15.0, P15.1, P15.2, P15.3, P15.4, P15.5, P15.6, P15.8, P15.9, P52.4, P52.6, P52.8, P52.9, Q99.2, R58, R62.0, R62.50, R62.59, S02.91XA, S06.1X0A, S06.1X1A, S06.1X2A, S06.1X3A, S06.1X4A, S06.1X5A, S06.1X6A, S06.1X7A, S06.1X8A, S06.1X9A, S06.890A, S07.0XXA, S07.1XXA, S07.8XXA, S07.9XXA, S09.10XA, S09.11XA, S09.19XA, S09.8XXA, S09.90XA, S09.92XA, S09.93XA, S14.109A, S14.119A, S14.129A, S14.139A, S14.149A, S14.159A, S16.8XXA, S16.9XXA, S17.0XXA, S17.8XXA, S17.9XXA, S19.80XA, S19.81XA, S19.82XA, S19.83XA, S19.84XA, S19.85XA, S19.89XA, S19.9XXA, S24.109A, S24.119A, S24.139A, S24.149A, S24.159A, S28.0XXA, S31.000A, S31.010A, S31.030A, S31.050A, S34.109A, S34.139A, S38.001A, S38.002A, S38.01XA, S38.02XA, S38.03XA, S38.1XXA, S38.3XXA, S47.1XXA, S47.2XXA, S47.9XXA, S57.00XA, S57.01XA, S57.02XA, S57.80XA, S57.81XA, S57.82XA, S67.00XA, S67.01XA, S67.02XA, S67.10XA, S67.190A, S67.191A, S67.192A, S67.193A, S67.194A, S67.195A, S67.196A, S67.197A, S67.198A, S67.20XA, S67.21XA, S67.22XA, S67.30XA, S67.31XA, S67.32XA, S67.40XA, S67.41XA, S67.42XA, S67.90XA, S67.91XA, S67.92XA, S77.00XA, S77.01XA, S77.02XA, S77.10XA, S77.11XA, S77.12XA, S77.20XA, S77.21XA, S77.22XA, S87.00XA, S87.01XA, S87.02XA, S87.80XA, S87.81XA, S87.82XA, S97.00XA, S97.01XA, S97.02XA, S97.101A, S97.102A, S97.109A, S97.111A, S97.112A, S97.119A, S97.121A, S97.122A, S97.129A, S97.80XA, S97.81XA, S97.82XA, T07, T14.8, T20.30XA, T20.311A, T20.312A, T20.319A, T20.32XA, T20.33XA, T20.34XA, T20.35XA, T20.36XA, T20.37XA, T20.39XA, T20.70XA, T20.711A, T20.712A, T20.719A, T20.72XA, T20.73XA, T20.74XA, T20.75XA, T20.76XA, T20.77XA, T20.79XA, T26.20XA, T26.21XA, T26.22XA, T26.40XA, T26.41XA, T26.42XA, T30.0, T30.4, T31.11, T31.20, T31.21, T31.22, T31.30, T31.31, T31.32, T31.33, T31.40, T31.41, T31.42, T31.43, T31.44, T31.50, T31.51, T31.52, T31.53, T31.54, T31.55, T31.60, T31.61, T31.62, T31.63, T31.64, T31.65, T31.66, T31.70, T31.71, T31.72, T31.73, T31.74, T31.75, T31.76, T31.77, T31.80, T31.81, T31.82, T31.83, T31.84, T31.85, T31.86, T31.87, T31.88, T31.90, T31.91, T31.92, T31.93, T31.94, T31.95, T31.96, T31.97, T31.98, T31.99, T32.11, T32.20, T32.21, T32.22, T32.30, T32.31, T32.32, T32.33, T32.40, T32.41, T32.42, T32.43, T32.44, T32.50, T32.51, T32.52, T32.53, T32.54, T32.55, T32.60, T32.61, T32.62, T32.63, T32.64, T32.65, T32.66, T32.70, T32.71, T32.72, T32.73, T32.74, T32.75, T32.76, T32.77, T32.80, T32.81, T32.82, T32.83, T32.84, T32.85, T32.86, T32.87, T32.88, T32.90, T32.91, T32.92, T32.93, T32.94, T32.95, T32.96, T32.97, T32.98, T32.99, T57.3X1A, T57.3X2A, T57.3X3A, T57.3X4A, T58.01XA, T58.02XA, T58.03XA, T58.04XA, T58.11XA, T58.12XA, T58.13XA, T58.14XA, T58.2X1A, T58.2X2A, T58.2X3A, T58.2X4A, T58.8X1A, T58.8X2A, T58.8X3A, T58.8X4A, T58.91XA, T58.92XA, T58.93XA, T58.94XA, T59.5X1A, T59.5X2A, T59.5X3A, T59.5X4A, T59.6X1A, T59.6X2A, T59.6X3A, T59.6X4A, T59.7X1A, T59.7X2A, T59.7X3A, T59.7X4A, T59.811A, T59.812A, T59.813A, T59.814A, T59.891A, T59.892A, T59.893A, T59.894A, T59.91XA, T59.92XA, T59.93XA, T59.94XA, T63.331A, T63.332A, T63.333A, T63.334A, T65.0X1A, T65.0X2A, T65.0X3A, T65.0X4A, T66.XXXA, T66.XXXS, T70.3XXA, T79.0XXA, T79.8XXA, T79.9XXA, T79.A0XA, T79.A11A, T79.A12A, T79.A19A, T79.A21A, T79.A22A, T79.A29A, T79.A3XA, T79.A9XA, T80.0XXA, T81.89XA, T84.010A, T84.011A, T84.012A, T84.013A, T84.018A, T84.019A, T84.030A, T84.031A, T84.032A, T84.033A, T84.038A, T84.039A, T84.040A, T84.041A, T84.042A, T84.043A, T84.048A, T84.049A, T84.050A, T84.051A, T84.052A, T84.053A, T84.058A, T84.059A, T84.060A, T84.061A, T84.062A, T84.063A, T84.068A, T84.069A, T84.090A, T84.091A, T84.092A, T84.093A, T84.098A, T84.099A, T84.110A, T84.111A, T84.112A, T84.113A, T84.114A, T84.115A, T84.116A, T84.117A, T84.119A, T84.120A, T84.121A, T84.122A, T84.123A, T84.124A, T84.125A, T84.126A, T84.127A, T84.129A, T84.190A, T84.191A, T84.192A, T84.193A, T84.194A, T84.195A, T84.196A, T84.197A, T84.199A, T84.210A, T84.213A, T84.216A, T84.218A, T84.220A, T84.223A, T84.226A, T84.228A, T84.290A, T84.293A, T84.296A, T84.298A, T84.310A, T84.318A, T84.320A, T84.328A, T84.390A, T84.398A, T84.410A, T84.418A, T84.420A, T84.428A, T84.490A, T84.498A, T84.81XA, T84.82XA, T84.83XA, T84.84XA, T84.85XA, T84.86XA, T84.89XA, T84.9XXA, T85.613A, T85.623A, T85.693A, T85.72XA, T85.79XA, T85.81XA, T85.82XA, T85.83XA, T85.84XA, T85.85XA, T85.86XA, T85.89XA, T86.820, T86.821, T86.822, T86.828, T86.829, T86.842, T86.848, T86.849, Z47.89, Z51.89, Z81.0, Z82.79, Z97.8, Z98.3, Z98.62, Z98.89, 5A05121, 5A05221, 6A150ZZ, 6A151ZZ

Procedural Codes: 99183, A4575
References
  1. UHMS.com – Hampton, N.B., chairman, Indications for Hyperbaric Oxygen Pressurization (1998). Undersea and Hyperbaric Medical Society, HBO2 Therapy Committee. Available at http://www.uhms.org (accessed – 1998).
  2. UHMS.com – Indications for Hyperbaric Oxygen Pressurization (2003 June). Undersea and Hyperbaric Medical Society, HBO2 Therapy Committee. Available at http://www.uhms.org (accessed – 2006 November 30).
  3. Scuba-Doc.com – Diving Medicine Online Approved Indications for HBO Therapy  (1996). Prepared by Ernest S. Campbell, M.D., F.A.C.S. Available at http://www.scuba-doc.com (accessed – 1998).
  4. Tibbles, P.M., and J.S. Edelsberg. Medical progress: Hyperbaric-oxygen therapy. The New England Journal of Medicine (1996 June 20) 334(25):1642-8.
  5. Rusyniak, D.E., Kirk, M.A., et al. Hyperbaric oxygen therapy in acute ischemic stroke: results of the Hyperbaric Oxygen in Acute Ischemic Stroke Trial Pilot Study. Stroke (2003 February) 34(2):571-4.
  6. Sharifi, M., Fares, W., et al. Usefulness of hyperbaric oxygen therapy to inhibit restenosis after percutaneous coronary intervention for acute myocardial infarction or unstable angina pectoris. American Journal of Cardiology (2004 June 15) 93(12):1533-5.
  7. Bennett, M., Jepson, N., et al. Hyperbaric oxygen therapy for acute coronary syndrome. Cochrane Database Systematic Review (2005) (2):CD004818.
  8. Topuz, E., Yigit, O., et al. Should hyperbaric oxygen be added to treatment of idiopathic sudden sensorineural hearing loss? European Archives of Oto-Rhino-Laryngology (2004 August) 261(7):393-6.
  9. Bennett, M., Kertesz, T., et al. Hyperbaric oxygen therapy for idiopathic sudden sensorineural hearing loss and tinnitus. Cochrane Database Systematic Review (2005) (1):CD004739.
  10. Eftedal, O.S., Lydersen, S., et al. A randomized, double blind study of the prophylactic effect of hyperbaric oxygen therapy on migraine. Cephalalgia (2004 August) 24(8):639-44.
  11. Steele, J., Matos, L.A., et al. A Phase I safety study of hyperbaric oxygen therapy for amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis and Other Motor Neuron Disorders (2004 December) 5(4):250-4.
  12. Van Voorhis, B.J., Greensmith, J.E., et al. Hyperbaric oxygen and ovarian follicular stimulation for in vitro fertilization: A pilot study. Fertility and Sterility (2005 January) 83(1):226-8.
  13. Hyperbaric Oxygen Therapy for Wound Healing – Part I. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program (1999 August) 14(13):1-55.
  14. Hyperbaric Oxygen Therapy for Wound Healing – Part II. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program (1999 December) 14(15):1-55.
  15. Hyperbaric Oxygen Therapy for Wound Healing – Part III. Chicago, Illinois: Blue Cross Blue Shield Association – Technology Evaluation Center Assessment Program (1999 December) 14(16):1-27.
  16. Collet, J.P., Vanasse, M., et al. Hyperbaric oxygen for children with cerebral palsy: A randomized multicenter trial. HBO-CP Research Group. Lancet (2001 February 24): 357(9256): 582-6.
  17. Heys, S.D., Smith, I.C., 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 and Hyperbaric Medicine (2006 January-February) 33(1):33-43.
  18. Bennett, M., Feldmeier, J., et al. Hyperbaric oxygen therapy for late radiation tissue injury. Cochrane Database Systematic Review (2005) (3): CD005005.
  19. Bennett, M., Feldmeier, J., et al. Hyperbaric oxygenation for tumor sensitization to radiotherapy. Cochrane Database Systematic Review (2005) (4):CD005007.
  20. Bennett, M., Best, T.M., et al. Hyperbaric oxygenation therapy for delayed onset muscle soreness and closed soft tissue injury. Cochrane Database Systematic Review (2005) (4):CD004713.
  21. Alex, J., Laden, G., et al. Pretreatment with hyperbaric oxygen and its effect on neuropsychometric dysfunction and systematic inflammatory response after cardiopulmonary bypass: A prospective randomized double-blind trial. Journal of Thoracic and Cardiovascular Surgery (2005 December) 130(6):1623-30.
  22. Carson, S., McDonagh, M., et al. Hyperbaric oxygen therapy for stroke: A systematic review of the evidence. Clinical Rehabilitation (2005 December) 19(8):819-33.
  23. Vila, J.F., Barcarce, P.E., et al. Improvement in motor and cognitive impairment after hyperbaric oxygen therapy in a selected group of patients with cerebrovascular disease: A prospective single-blind controlled trial. Undersea and Hyperbaric Medicine (2006 September-October) 32(5):341-9.
  24. Bennett, M., Stanford, R., et al. Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union. Cochrane Database Systematic Review (2005) (1):CD004712.
  25. Al-Waili, N.S., and G.J. Butler. Phototherapy and malignancy: Possible enhancement by iron administration and hyperbaric oxygen. Medical Hypotheses (2006) 67(5):1148-58.
  26. Hyperbaric Oxygen Therapy – Recent Findings on Evidence for its Effectiveness. Calgary, Alberta, Canada: Alberta Heritage Foundation for Medical Research – Information Paper, Health Technology Assessment (2003 March) IP 13:1-25.
  27. Rossignol, D.A., and L.W. Rossignol. Hyperbaric oxygen therapy may improve symptoms in autistic children. Medical Hypotheses (2006) 67(2):216-28.
  28. Rossignol, D.A. Hyperbaric oxygen therapy might improve certain pathophysiological findings in autism. Medical Hypotheses (2007) 68(6):1208-27.
  29. Myers, S.M., and C.P. Johnson. Clinical Report: Management of children with autism spectrum disorders. Pediatrics (2007 November) 120(5):1162-82.
  30. Rossignol, D.A., Rossignol, L.W., et al. The effects of hyperbaric oxygen therapy on oxidative stress, inflammation, and symptoms in children with autism: an open-label pilot study. BMC Pediatrics (2007) 7:36.
  31. UHMS.com – Indications for Hyperbaric Oxygen Pressurization (2008). Undersea and Hyperbaric Medical Society, HBO2 Therapy Committee. (accessed – 2009 October 1) <http://www.uhms.org>.
  32. Heng, M.C., Pilgrim, J.P., et al. A simplified hyperbaric oxygen technique for leg ulcers. Archives of Dermatology (1984 May) 120(5):640-5.
  33. Leslie, C.A., Sapico, F.L., et al. Randomized controlled trial of topical hyperbaric oxygen for the treatment of diabetic foot ulcers. Diabetes Care (1988 February) 11(2):111-5.
  34. Edsberg, L.E., Brogan, M.S., et al. Topical hyperbaric oxygen and electrical stimulation: exploring potential synergy. Ostomy Wound Management (2002 November) 48(11):42-50.
  35. Ambiru, S., Furuyama, N., et al. Hyperbaric oxygen therapy for the treatment of postoperative paralytic ileus and adhesive intestinal obstruction associated with abdominal surgery: experience with 626 patients. Hepatogastroenterology (2007 October-November) 54(79):1925-9.
  36. Christophi, C., Millar, I., et al. Hyperbaric oxygen therapy for severe acute pancreatitis. Journal of Gastroenterology and Hepatology (2007 November) 22(11):2042-6.
  37. Kranke P, Bennett MH, Martyn-St James M et al. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev 2012; 4:CD004123.
  38. 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):186-90.
  39. 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.
  40. Buckley NA, Juurlink DN, Isbister G et al. Hyperbaric oxygen for carbon monoxide poisoning. Cochrane Database Syst Rev 2011; (4):CD002041.
  41. 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):138-52.
  42. Scheinkestel CD, Bailey M, Myles PS et al. Hyperbaric or normobaric oxygen for acute carbon monoxide poisoning: a randomized controlled clinical trial. Med J Aust 1999; 170(5):203-10.
  43. Logue CJ. An inconvenient truth? Ann Emerg Med 2008; 51(3):339-40; author reply 40-2.
  44. Weaver LK, Hopkins RO, Chan KJ et al. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl J Med 2002; 347(14):1057-67.
  45. 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.
  46. 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.
  47. Bennett MH, Feldmeier J, Hampson N et al. Hyperbaric oxygen therapy for late radiation tissue injury. Cochrane Database Syst Rev 2012; 5:CD005005.
  48. Bennett MH, Feldmeier J, Hampson N et al. Hyperbaric oxygen therapy for late radiation tissue injury. Cochrane Database Syst Rev 2005; (3):CD005005.
  49. 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):691-4.
  50. 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.
  51. 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):1210-7.
  52. 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.
  53. 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):114-21.
  54. Chen CY, Lee SS, Chan YS et al. Chronic refractory tibia osteomyelitis treated with adjuvant hyperbaric oxygen: a preliminary report. Changgeng Yi Xue Za Zhi 1998; 21(2):165-71.
  55. 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.
  56. Jallali N, Withey S, Butler PE. Hyperbaric oxygen as adjuvant therapy in the management of necrotizing fasciitis. Am J Surg 2005; 189(4):462-6.
  57. 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):21-8.
  58. Bennett MH, Lehm JP, Jepson N. Hyperbaric oxygen therapy for acute coronary syndrome. Cochrane Database Syst Rev 2011; (8):CD004818.
  59. 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):1623-30.
  60. Holland NJ, Bernstein JM, Hamilton JW. Hyperbaric oxygen therapy for Bell's palsy. Cochrane Database Syst Rev 2012; 2:CD007288.
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  62. Bennett MH, Kertesz T, Yeung P. Hyperbaric oxygen for idiopathic sudden sensorineural hearing loss and tinnitus. Cochrane Database Syst Rev 2007; (1):CD004739.
  63. 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):1154-7.
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  68. 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):1732-9.
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History
April 2012 Policy name changed from Hyperbaric Oxygen Therapy to Hyperbaric Oxygen Pressurizztion (HBO); updated with literature review through June 2011; acute surgical and traumatic wounds, idiopathic femoral neck necrosis, chronic arm lymphedema following radiotherapy for cancer, and radiation-induced injury in the head and neck added as investigational. References 9, 10, 46, 48-49, 51-54 added; other references renumbered or removed. Policy statement change from not medically necessary to Investigational.
October 2012 Policy updated with literature review through June 2012. References 8, 18-20, 30, 35-37, 47-48 and 59 added; other references renumbered or removed. Bell’s palsy added as investigational. “Chronic wounds, other than those in patients with diabetes who meet the criteria specified in the medically necessary statement” added to investigational statement. Crush injuries, reperfusion injury, compartment syndrome added as examples in bullet point on acute traumatic ischemia. Policy corrected with acute ischemic stroke added as investigational.
July 2013 Policy formatting and language revised.  Title changed from "Hyperbaric Oxygen Pressurization (HBO)" to "Hyperbaric Oxygen (HBO2) Pressurization".  Policy allows between 5 and 30 sessions depending on indication. 
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Hyperbaric Oxygen (HBO2) Pressurization