| Clinical UM Guideline |
| Subject: Hyperbaric Oxygen Therapy (Systemic/Topical) | |
| Guideline #: CG-MED-73 | Publish Date: 12/16/2020 |
| Status: Reviewed | Last Review Date: 11/05/2020 |
| Description |
This document addresses the use of hyperbaric oxygen therapy (HBOT), which can be applied systemically, topically, or to one or more limbs alone. HBOT involves the use of pressurized room air, 100% oxygen, or room air enriched with a specific concentration of oxygen. The premise of HBOT is that the increased pressure results in increased oxygen levels in systemic circulation and the body’s tissues with the goal of improving healing of wounds, injuries or to support oxygen transport in acutely anemic or hypoxic individuals.
| Clinical Indications |
Medically Necessary:
Systemic hyperbaric oxygen pressurization is considered medically necessary in the treatment of any of the following conditions when performed in accordance with Undersea and Hyperbaric Medical Society (UHMS) guidelines:
Not Medically Necessary:
If the wound fails to show measurable signs of healing within 30 days of initiating and at each subsequent 30 day interval of systemic hyperbaric oxygen pressurization, continued therapy is considered not medically necessary.
Topical hyperbaric oxygen is considered not medically necessary in all cases.
Limb specific hyperbaric oxygen pressurization is considered not medically necessary in all cases.
Systemic hyperbaric oxygen pressurization is considered not medically necessary for all other conditions not previously listed, including but not limited to the following:
| Coding |
The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.
Systemic HBOT:
When services are Medically Necessary:
| CPT |
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| 99183 | Physician or other qualified health care professional attendance and supervision of hyperbaric oxygen therapy, per session |
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| HCPCS |
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| G0277 | Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval |
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| ICD-10 Procedure |
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| 5A05121 | Extracorporeal hyperbaric oxygenation, intermittent |
| 5A05221 | Extracorporeal hyperbaric oxygenation, continuous |
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| ICD-10 Diagnosis |
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| A42.0-A42.9 | Actinomycosis |
| A48.0 | Gas gangrene |
| B36.0-B36.9 | Other superficial mycoses |
| B37.0-B37.9 | Candidiasis |
| B46.0-B46.9 | Zygomycosis |
| B48.0-B48.8 | Other mycoses, not elsewhere classified |
| B49 | Unspecified mycosis |
| D62 | Acute posthemorrhagic anemia |
| G06.0 | Intracranial abscess and granuloma |
| H34.10-H34.13 | Central retinal artery occlusion |
| H70.201-H70.229 | Petrositis |
| I74.2-I74.9 | Embolism and thrombosis of arteries (upper/lower extremities, iliac artery) |
| I96 | Gangrene, not elsewhere classified |
| I99.9 | Unspecified disorder of circulatory system |
| K62.7 | Radiation proctitis |
| L08.0-L08.9 | Other local infections of skin and subcutaneous tissue |
| L59.8-L59.9 | Other disorders of the skin and subcutaneous tissue related to radiation |
| L88 | Pyoderma gangrenosum |
| M27.2 | Inflammatory conditions of jaws |
| M72.6 | Necrotizing fasciitis |
| M79.9 | Soft tissue disorder, unspecified |
| M79.A11-M79.A9 | Nontraumatic compartment syndrome |
| M86.30-M86.69 | Chronic osteomyelitis |
| M86.8X0-M86.8X9 | Other osteomyelitis |
| M86.9 | Osteomyelitis, unspecified |
| N30.40-N30.41 | Irradiation cystitis |
| S07.0XXA-S07.9XXS | Crushing injury of head |
| S17.0XXA-S17.9XXS | Crushing injury of neck |
| S28.0XXA-S28.0XXS | Crushed chest |
| S38.001A-S38.1XXS | Crushing injury of abdomen, lower back, pelvis and external genitals |
| S45.001A-S45.099S | Injury of axillary artery |
| S45.801A-S45.999S | Unspecified injury of other blood vessels at shoulder and upper arm level |
| S47.1XXA-S47.9XXS | Crushing injury of shoulder and upper arm |
| T20.20XA-T20.29XS | Burn of second degree of head, face, and neck |
| T20.30XA-T20.39XS | Burn of third degree of head, face, and neck |
| T21.20XA-T21.29XS | Burn of second degree of trunk |
| T21.30XA-T21.39XS | Burn of third degree of trunk |
| T22.20XA-T22.299S | Burn of second degree of shoulder and upper limb, except wrist and hand |
| T22.30XA-T22.399S | Burn of third degree of shoulder and upper limb, expect wrist and hand |
| T23.201A-T23.299S | Burn of second degree of wrist and hand |
| T23.301A-T23.399S | Burn of third degree of wrist and hand |
| T24.201A-T24.299S | Burn of second degree of lower limb, except ankle and foot |
| T24.301A-T24.399S | Burn of third degree of lower limb, except ankle and foot |
| T25.211A-T25.299S | Burn of second degree of ankle and foot |
| T25.311A-T25.399S | Burn of third degree of ankle and foot |
| T31.0-T31.99 | Burns classified according to extent of body surface involved |
| T57.3X1A-T57.3X4S | Toxic effect of hydrogen cyanide |
| T58.01XA-T58.94XS | Toxic effect of carbon monoxide |
| T65.0X1A-T65.0X4S | Toxic effect of cyanides |
| T66.XXXA-T66.XXXS | Radiation sickness, unspecified |
| T70.3XXA-T70.3XXS | Caisson disease [decompression sickness] |
| T79.0XXA-T79.0XXS | Air embolism (traumatic) |
| T79.A0XA-T79.A0XS | Compartment syndrome, unspecified |
| T79.A11A-T79.A9XS | Traumatic compartment syndrome |
| T86.820-T86.829 | Complications of skin graft (allograft)(autograft) |
When services may be Medically Necessary when criteria are met:
For the procedure codes listed above for the following diagnoses
| ICD-10 Diagnosis |
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| E08.00-E11.9 | Diabetes mellitus |
| E13.00-E13.9 | Other specified diabetes mellitus |
| I73.89 | Other specified peripheral vascular diseases |
| I73.9 | Peripheral vascular disease, unspecified |
| L89.000-L89.95 | Pressure ulcer |
| L97.101-L97.929 | Non-pressure chronic ulcer of lower limb, not elsewhere classified |
| L98.411-L98.499 | Non-pressure chronic ulcer of skin, not elsewhere classified |
| S01.00XS-S01.95XS | Open wound of head [range with 7th character S] |
| S11.011S-S11.95XS | Open wound of neck [range with 7th character S] |
| S21.001S-S21.95XS | Open wound of thorax [range with 7th character S] |
| S31.000S-S31.839S | Open wound of abdomen, lower back, pelvis and external genitals [range with 7th character S] |
| S41.001S-S41.159S | Open wound of shoulder and upper arm [range with 7th character S] |
| S51.001S-S51.859S | Open wound of elbow and forearm [range with 7th character S] |
When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for all other diagnoses not listed, or when the code describes a procedure or situation designated in the Clinical Indications section as not medically necessary.
Topical HBOT:
When services are Not Medically Necessary:
| HCPCS |
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| A4575 | Topical hyperbaric oxygen chamber, disposable |
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| ICD-10 Diagnosis |
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| All diagnoses |
| Discussion/General Information |
Systemic Hyperbaric Oxygen Therapy
Systemic hyperbaric oxygen therapy (HBOT) involves the inhalation of pure oxygen gas while enclosed in a high-pressure chamber (defined as pressure greater than standard atmospheric pressure). The pressures used are usually between 1.4 to 3.0 atmospheres absolute (atm abs or ATA). The therapy works by supersaturating the blood tissues with oxygen via increased atmospheric pressure as well as increased oxygen concentrations. Studies have demonstrated that this therapy increases the available oxygen to the body by 10 to 20 times normal levels. Treatment may be carried out in either a monoplace chamber pressurized with pure oxygen or in a larger, multiplace chamber pressurized with compressed air, in which case the individual receives pure oxygen by mask, head tent, or endotracheal tube. The number and duration of treatment sessions and the atmospheric pressure during treatment varies depending on the specific condition being treated, the severity of the condition, and the procedures developed by individual hospitals and clinics. These individual procedures vary widely and have made the evaluation of the efficacy of hyperbaric oxygen therapy difficult.
The position regarding systemic hyperbaric oxygen is based on guidelines published by the Undersea and Hyperbaric Medical Society (UHMS) (2019). These guidelines provide recommendations for indications where hyperbaric oxygen therapy has been demonstrated to provide clinical benefits. For the majority of these indications, there are adequate data to provide guidance regarding treatment duration, frequency and depth of pressurization. One exception is idiopathic sudden sensorineural hearing loss, which is discussed separately below.
Several systematic reviews and meta-analyses on HBOT for diabetic-related lower limb ulcers have recently been published (Brouwer, 2019; Golledge, 2019; Lalieu, 2020). Golledge and colleagues (2019) identified 9 randomized controlled trials (RCTs) with a total of 585 participants. Pooled analyses found significantly greater likelihood of ulcer healing with HBOT compared with standard care (relative risk [RR], 1.95; 95% confidence interval [CI], 1.51-2.52; p<0.001). In addition, there was a significantly lower likelihood of major amputation with HBOT (RR, 0.54; 95% CI, 0.36-0.81; p=0.003). Brouwer and colleagues (2019) focused on diabetic foot ulcers with arterial insufficiency. The authors identified 11 relevant studies of which 7 were RCTs. A meta-analysis of 4 studies found a significantly lower rate of major amputation in individuals treated with HBOT versus a control intervention (risk difference [RD]: -0.15; 95% CI, -0.25 to -0.06. There were no significant differences between groups in pooled analysis (3 studies each) of rates of minor amputations, mean healing time or mortality.
Undersea and Hyperbaric Medical Society Guidelines:
The UHMS Hyperbaric Oxygen Therapy Committee (14th edition) recommended indications, along with the recommended treatment dose and number of treatment sessions is as follows:
In 2012, the American Academy of Neurology and the American Headache Society released guidelines regarding the use of complementary treatments for episodic migraine prevention in adults (Holland, 2012). These guidelines concluded that the data are conflicting or inadequate to support or refute hyperbaric oxygen for migraine prevention.
Tinnitus and Idiopathic Sudden Sensorineural Hearing Loss
In October of 2011, the UHMS added ISSHL to their list of indications. The rationale for the UHMS recommendation on ISSHL was based upon the findings of a 2012 Cochrane Review by Bennett and colleagues. The Cochrane review identified seven small RCTs, which were generally considered to be of low quality. Although the Cochrane review stated that, “for people with acute ISSHL, the application of HBOT significantly improved hearing”, as noted by the UHMS, the Cochrane review’s conclusions went on to state that the clinical significance of HBOT for treatment of ISSHL “remains unclear”. The 2019 UHMS guidelines also cited the Cvorovic (2013) RCT in the section on salvage therapy for ISSHL. The Cvorovic (2013) study involved 50 individuals who had failed primary therapy for SSHL. Participants were assigned to either HBOT (n=25) or intratympanic steroid treatment. There were significant differences between hearing thresholds at all frequencies before and after the HBOT. Similarly, there were significant differences between hearing thresholds at most frequencies (except 2 kHz) before and after the treatment in the intratympanic treatment group. There were no significant differences between HBOT and steroid treatment at 4 of the 5 frequencies. At 2 kHz, HBOT was found to be superior to steroid treatment.
The 2012 Cochrane review, discussed above, also addressed HBOT for treatment of tinnitus. Only two trials reported mean improvement in tinnitus or the proportion of individuals with tinnitus and findings were mixed. Data were not suitable for pooling. The review concluded that no beneficial effect of HBOT on tinnitus was found.
In 2019, the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) published an updated clinical practice guideline on sudden hearing loss. The guideline group supported hyperbaric oxygen therapy combined with steroid therapy for treatment of sudden sensorineural hearing loss. For initial treatment, they recommend initiating hyperbaric oxygen therapy within 2 weeks of the condition’s onset and, for salvage therapy, within 1 month of onset. The recommendations differ from those in the 2012 guideline in that HBOT was only considered an option when combined with steroid therapy. The recommendation on hyperbaric oxygen therapy was rated “Grade B, systematic review of RCTs with methodological limitations” and was based primarily on the 2012 Cochrane review by Bennett and colleagues, discussed above.
A 2018 systematic review and meta-analysis (Rhee 2018) addressed HBOT versus medical therapy alone for treatment of ISSHL. The authors identified 3 RCTs and 16 non-randomized comparative studies, published through February 2018, that compared HBOT plus medical therapy versus medical therapy alone. Fourteen of the 16 non-randomized studies were retrospective. . In a pooled analysis, the rate of complete hearing recovery was 264 of 897 cases (29.4%) in the HBOT plus medical therapy group and 241 of 1167 (20.7%) in the medical therapy alone group. A meta-analysis significantly favored the HBOT plus medical therapy group for this outcome (pooled OR, 1.61; 95% CI: 1.05 to 2.44). The outcome variable assessing any hearing recovery also significantly favored the HBOT plus medical therapy group (pooled OR, 1.43, 95% CI, 1.20 to 1.66). There was significant heterogeneity for both outcomes; thus, a random effects model was used. A limitation of the meta-analysis is that 16 of the 19 studies identified were non-randomized, and 14 were retrospective and these are subject to selection bias and other potential biases.
Several RCTs have compared HBOT and medical therapy, with mixed results. Cho and colleagues (2018) randomized 60 individuals with severe to profound ISSHL to medical therapy alone (oral steroids plus intratympanic steroids) alone and medical therapy plus HBOT. Hearing improvement was assessed 3 months after treatment using the AAO-HNS criteria to determine treatment success. Using these criteria, no significant differences in hearing improvement were found between groups. In addition, there were no significant differences between groups in percent word discrimination score (WDS) gain at 1 month and 2 months, but WDS improvement was significantly higher in the study group at 3 months (p=0.035). Tong and colleagues (2020) randomly assigned 136 individuals with unilateral ISSHL to medical therapy alone (oral prednisone, vitamins and traditional Chinese drugs) or medical therapy plus HBOT. Treatment success was defined as complete recovery, marked improvement or slight improvement in hearing, an improvement of at least 15 dB. Using this definition, the success rate was 60.6% (40 of 66) in the group receiving HBOT and 42.9% (30 of 70) in the group receiving medical treatment only, p<0.05.
Overall, the evidence supporting the use of HBOT for the treatment of tinnitus and ISSHL is currently insufficient to draw reasonable conclusions about the efficacy of this therapy.
Other conditions
The use of HBOT has been proposed for a wide range of conditions in addition to those addressed by the UHMS. Most, including cerebral edema, spinal cord injury, and heat trauma have little clinical data to support HBOT therapy.
There is also insufficient evidence on traumatic brain injury. A 2012 Cochrane review included 7 RCTs evaluating HBOT as an adjunctive treatment of traumatic brain injury. The review concluded that although HBOT may reduce the risk of death and result in statistically significant improvement in scores on the Glasgow Outcome Scale, there is a lack of evidence that the degree of improvement is clinically significant.
Several RCTs on HBOT for post-concussion symptoms due to traumatic brain injury were published after the Cochrane review. Miller and colleagues (2015) randomized 72 . individuals to 40 HBOT sessions at 1.5 ATA, 40 sham treatments with room air at 1.2 ATA, or no supplemental treatments. While a significant difference was reported between both supplemental groups and the no-supplemental group, (p=0.008), no differences were reported between the hyperbaric and the sham treatment groups. A 2020 crossover trial by Harch and colleagues included 63 individuals who received 40 HBOT sessions over 2 months or no treatment, in random order. Eight of 14 outcome variables improved significantly more in the treatment group than the control group. These included depression and post-traumatic anxiety symptoms.
Topical and Limb Specific Hyperbaric Oxygen Therapy
Topical HBOT involves the delivery of pure oxygen directly to an open, moist wound at a pressure slightly higher than atmospheric pressure. Limb-specific HBOT involves the use of a plastic container into which the limb to be treated is inserted and then sealed with pliable gaskets. The limb is then subjected to increased pressure and oxygen concentrations. The rest of the body is not exposed to this treatment. Topical and systemic HBOT are distinct technologies and are applied by different methods. As such, the outcomes associated with systemic HBOT cannot be extrapolated to topical therapy. Topical HBOT has been primarily evaluated as a treatment of chronic wounds, but other conditions have also been proposed as possible indications. There is currently insufficient published data from controlled trials to permit conclusions regarding topical HBOT. Additionally, evidence in the form of data from in vitro studies of limb specific HBOT have failed to demonstrate that this treatment method increases tissue oxygen tension beyond the superficial dermis, a key factor in the efficacy of HBOT.
| Definitions |
Anemia: A reduction in the number of circulating red blood cells or in the total hemoglobin content of the cells.
Atmospheres absolute (ATA): The combination (or the sum) of the atmospheric pressure and the hydrostatic pressure is called atmospheres absolute (ATA). In other words, the ATA or atmospheres absolute is the total weight of the water and air above us.
Carbon monoxide poisoning: Toxicity that results from inhalation of small amounts of carbon monoxide (a poisonous gas) over a long period of time or from large amounts inhaled for a short time, which leads to decreased oxygen delivery to the body and cerebral toxicity.
Chronic: Of a long duration; a disease that persists or progresses over time.
Cierny-Mader system for osteomyelitis:
Anatomic type:
Stage 1: medullary osteomyelitis
Stage 2: superficial osteomyelitis
Stage 3: localized osteomyelitis
Stage 4: diffuse osteomyelitis
Physiologic class:
A host: healthy
B host:
Bs: systemic compromise
Bl: local compromise
Bls: local and systemic compromise
C host: treatment worse than the disease
Compartmental syndrome: Any condition in which a structure, such as a nerve or tendon, is being constricted in a space and is no longer able to move freely in the compartment.
Decompression sickness: A condition that develops in divers subjected to rapid reduction of air pressure after coming to the surface following exposure to compressed air.
Gangrene: The death of tissue or bone, usually resulting from a deficient or absent blood supply.
Gas embolism: Obstruction of a blood vessel by a gas bubble.
Ischemia: A local and temporary deficiency of blood supply due to an obstruction of the circulation.
Limb specific hyperbaric oxygen: A therapy that involves sealing an individual’s leg or arm into an airtight container and exposing that limb to pure oxygen greater than one atmosphere of pressure.
Mycosis: Any condition caused by a fungus.
Necrosis: A condition where cells or tissues are dead or dying.
Osteomyelitis: Inflammation of the bone due to infection.
Osteoradionecrosis: Death of bone following irradiation.
Prophylactic: Any agent or treatment that contributes to the prevention of infection or disease.
Pyoderma gangrenosum: A condition of the skin leading to open ulcers.
Systemic hyperbaric oxygen: A therapy that involves sealing an individual inside a room or container, then exposing the individual to pure oxygen at greater than one atmosphere of pressure.
Thermal: Related to heat.
Tinnitus: A condition where an individual has the perception of sound in their head when no outside sound is present. It is typically referred to as “ringing in the ears” or “head noise,” but other forms of sound have been described such as hissing, roaring, pulsing, whooshing, chirping, whistling and clicking.
Topical hyperbaric oxygen: A therapy that involves sealing skin wounds under a plastic cover and then exposing the wound to pure oxygen at greater than one atmosphere of pressure; an alternate form of this therapy involves the application of a mist of water droplets to the wound that are saturated with dissolved oxygen.
| References |
Peer Reviewed Publications:
Government Agency, Medical Society, and Other Authoritative Publications:
| Websites for Additional Information |
| Index |
Air embolism
Extreme chamber therapy
Extremity oxygen therapy
Osteomyelitis, acute and chronic
Osteoradionecrosis
Tinnitus
The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available
| History |
| Status | Date | Action |
| Reviewed | 11/05/2020 | Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Discussion/General Information and References sections. Reformatted Coding section. |
|
| 05/19/2020 | In Discussion section, added note to the section on Undersea and Hyperbaric Medicine society guidelines that Idiopathic Sudden Sensorineural Hearing Loss (ISSHL) is considered ‘not medically necessary’. |
| Reviewed | 11/07/2019 | MPTAC review. Updated Discussion/General Information and References sections. |
| Revised | 01/24/2019 | MPTAC review. Updated Clinical Indications with additional details on treatment of wounds and jaw conditions consistent with Undersea and Hyperbaric Medicine Society recommendations. Parentheses with refractory osteomyelitis removed from chronic refractory osteomyelitis in medically necessary statement. Added to not medically necessary statement: Idiopathic Sudden Sensorineural Hearing Loss (ISSHL), osteonecrosis of the jaw when the cause is not radiation necrosis (osteoradionecrosis), preoperative treatment for jaw osteomyelitis, traumatic brain injury and venous stasis ulcers, pressure ulcers and non-pressure ulcers except in the subset of individuals noted in the medically necessary statement. Discussion/General Information and References updated. |
| New | 07/26/2018 | MPTAC review. Initial document development. Moved content of MED.00005 Hyperbaric Oxygen Therapy (Systemic/Topical) to new clinical utilization management guideline document with the same title. |
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