Medical Policy: 02.01.13 

Original Effective Date: September 1999 

Reviewed: March 2018 

Revised: March 2018 

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Hyperbaric oxygen therapy (HBOT) is a technique of delivering higher pressures of oxygen to the tissues and is used for the management in a variety of medical conditions, such as air embolism, acute traumatic injury, thermal and radiation injuries, infections and complicated wound management. There are two methods of administration available, systemic and topical.

 

Systemic Hyperbaric Oxygen Therapy

Systemic hyperbaric oxygen therapy involves breathing 100% oxygen at an elevated (i.e. greater than sea level) atmosphere absolute (ATA) of at least 1.4, although pressure is typically between 2 and 3 ATA. Individuals typically spend one to two hours in the chamber per session as determined by the professional provider. It is generally applied with the patient inside a hyperbaric chamber, either a monoplace or multiplace chamber. This technique relies on systemic circulation to deliver highly oxygenated blood to the target site, typically a wound. In addition, systemic HBOT can be used to treat various systemic illnesses.

  • Monoplace Chamber: This accommodates a single patient, the entire chamber is pressurized with near 100% oxygen and the patient breathes the ambient chamber oxygen directly.
  • Multiplace Chamber: This holds two or more people (patients, observers, and/or support personnel), the chamber is pressurized with compressed air while the patients breathe near 100% oxygen via masks, head hoods or endotracheal tubes.

 

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

 

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

 

Documentation regarding hyperbaric oxygen therapy should include the hyperbaric procedure logs with ascent time, descent time and pressurization level. In addition, there should be a treatment plan identifying timeline and treatment goals.

 

The evidence for the use of systemic hyperbaric oxygen therapy (HBOT) in individuals with decompression sickness, acute carbon monoxide poisoning, gas gangrene, compromised skin grafts or flaps, prophylactic pre-operative and post-operative treatment for patients undergoing dental surgery (non-implant related) of an irradiated jaw, chronic non-healing wounds, profound/severe anemia with exceptional blood loss, only when blood transfusion is impossible or must be delayed, acute cyanide poisoning, air or gas embolism, progressive necrotizing infections (necrotizing fasciitis), acute peripheral arterial insufficiency, osteomyelitis refractory to conventional medical and surgical management, acute traumatic ischemia (e.g. crush injuries, reperfusion injury, compartment syndrome), actinomycosis only when refractory to antibiotics and surgical treatment, diabetic wounds of the lower extremities with a wound classification as Wagner Grade III or higher that has failed standard wound therapy for at least 30 consecutive days with no measureable signs of healing, idiopathic sudden sensorineural hearing loss, central retinal artery obstruction, delayed radiation injuries (soft tissue and bony necrosis), acute thermal burns, deep partial thickness (second degree) and full thickness burns (third degree), and intracranial abscess includes systematic reviews, randomized controlled trials (RCTs) and case series. The literature also includes society guidelines to include regarding the indications for use of hyperbaric oxygen therapy as an adjunct to medical and surgical management. Relevant outcomes include overall survival, symptoms, changes in disease status, and functional outcomes. Based on the peer reviewed medical literature for all of the above listed indications, the evidence is sufficient to determine that hyperbaric oxygen therapy (HBOT) results in a meaningful improvement in net health outcomes.

 

For all other indications listed below, literature searches did not identify sufficient evidence to support the use of systemic hyperbaric oxygen therapy (HBOT). There is insufficient evidence establishing that systemic HBOT is more effective than conventional therapies. Further randomized controlled trials (RCTs) are needed to include double blind comparisons of HBOT to sham HBOT. The evidence is insufficient in determining the effects of the technology on net health outcomes.

  • Acute carbon tetrachloride poisoning
  • Acute cerebral edema
  • Acute coronary syndromes and as adjunct to coronary artery interventions including but not limited to percutaneous coronary interventions and cardiopulmonary bypass
  • Acute frost bite
  • Acute thermal burns (except as described above)
  • AIDS/HIV
  • Alzheimer’s disease
  • Asthma
  • Autism spectrum disorder (ASD)
  • Bell’s palsy
  • Bone graft
  • Brain injury, acute and traumatic brain injury (TBI)
  • Brown recluse spider bite (necrotizing arachnidism)
  • Cerebral palsy
  • Cerebrovascular disease, acute (thrombotic or embolic) or chronic
  • Chronic arm lymphedema following radiotherapy for cancer
  • Crohn’s disease (includes fistulizing Crohn’s disease)
  • Demyelinating disease including but not limited to multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS)
  • Depression
  • Early treatment (beginning at the completion of radiation therapy) to reduce side effects of radiation therapy
  • Fracture healing
  • Heart disease
  • Hepatitis
  • Hydrogen sulfide poisoning
  • Idiopathic femoral head necrosis
  • Idiopathic sensorineural hearing loss (other than described above)
  • Intra-abdominal abcesses
  • In-vitro fertilization
  • Lepromatous leprosy
  • Meningitis
  • Migraine headaches/headaches
  • Motor dysfunction associated with stroke
  • Neurologic conditions
  • Parkinson’s disease
  • Preconditioning to improve myocardial function and/or reduce postoperative complications in patients undergoing coronary artery bypass grafting (CABG)
  • Pseudomembranous colitis (antimicrobial agent-induced colitis)
  • Pyoderma gangrenosum
  • Radiation induced injury of head and neck
  • Refractory mycoses (other than actinomycosis as described above)
  • Spinal cord injury
  • Sports injury
  • Tumor sensitization for cancer treatments including but not limited to radiotherapy or chemotherapy

 

Topical Hyperbaric Oxygen Therapy

Topical oxygen ation, also referred to as topical hyperbaric oxygen therapy, is a technique of delivering 100% oxygen directly to an open, moist wound at a pressure slightly higher than atmospheric pressure. The theory behind this therapy is that the high concentrations of oxygen diffuse directly into the wound to increase the local cellular tension, which in turn promotes wound healing. Devices consist of an appliance to enclose the wound area (usually an extremity) and a cource of oxygen is delivered under pressure from a source such as a conventional oxygen tank. This therapy has been promoted as a treatment for diabetic and venous stasis ulcers, infected wounds, gangrenous lesion, decubitus ulcers, amputations, skin graft, burns or frostbite. Topical oxygenation may be performed in the home or clinic and office setting. Typically, therapy is offered for 90 minutes per day for four consecutive days. After a three-day break, the cycle may be repeated.

 

In 2017, de Smet et. al. conducted a systematic review of various oxygen therapies: oxygen dressing therapy; topical oxygen therapy, hyperbaric oxygen therapy and supplemental inspired oxygen therapy. Sixty-five articles were identified. Many of the studies showed positive outcomes regarding the use of oxygen treatment in the stimulation of wound healing. However, the lack of clinical studies and vast methodological diversity made it impossible to perform a proper comparison within and between the different therapies. The authors concluded that further randomized clinical studies are warranted to examine the value of these therapies, especially studies that investigate the more patient-friendly oxygen dressings and topical wound oxygen therapies. Also, to achieve more solid and consistent data, studies should use more standardized methods and subjects.

 

Based on review of the peer reviewed medical literature, there is minimal and insufficient data to conclude that the use of topical hyperbaric oxygen therapy results in improved net health outcomes. Further randomized clinical studies are warranted to examine the value of this therapy.

 

Topical Continuous Oxygen Therapy (TCOT)

Topical continuous oxygen therapy (TCOT), also known as transdermal continuous oxygen wound therapy or continuous diffusion oxygen (CDO) therapy is a portable oxygen delivery system that provides a continuous flow of oxygen to a wound. The device combines a specialized process to extract oxygen from the air and delivers it to the wound via a very small cannula (tube). The end of the cannula (tube) is placed onto the wound site and covered with an occlusive dressing or pressure dressing. The oxygen is delivered at a low flow rate so the wound will not dry out. Topical continuous oxygen therapy (TCOT) has been proposed in the treatment of skin ulcerations resulting from diabetes, venous stasis, post-surgical infections, gangrenous lesions, pressure ulcers/decubitus ulcers, infected residual limbs, skin grafts, burns and frostbite.

 

The goal of topical continuous oxygen therapy is to provide an uninterrupted and continuous supply of oxygen to a moist wound. The dressing is designed such that the oxygen is supplied in a manner that most closely approximates the normal diffusion of oxygen in moist tissues, yet a rate sufficient to fuel the increased oxygen demands required in healing tissues. With this therapy the dressing helps provide an environment for optimal wound healing while managing wound exudate levels, protecting against wound dehydration and protecting against external contamination. Contraindications to this wound therapy includes wounds with inadequate perfusion to support healing; ulcers due to acute thromobophlebitis; ulcers due to Raynaud’s disease; necrotic wounds covered with eschar or slough; wounds with fistulae or deep sinus tracts with unknown depth.

 

The following are topical continuous oxygen therapy (TCOT) devices:

  • EPIFLO® Transdermal Continuous Oxygen Therapy (Ogenix) consists of a small, silent, disposable, oxygen concentrator and a long sterile cannula (tube). It is used with any fully occlusive sterile wound dressing to continuously blanket the wound with near 100% oxygen. The patient is free to ambulate and can continue with normal daily living activities while being treated 24 hours per day. EPIFLO® can be worn near the wound beneath clothing without impairing its operation.
  • EPIFLO® extracts oxygen from the air, concentrates it to near 100%, and “pumps” the oxygen through the cannula to blanket the wound. The wound is covered with a fully occlusive dressing of the doctors choice. The dressing does not inflate and the patient has no sensation of air movement. EPIFLO® provides a silent, continuous, slow flow of oxygen (3 ml/hr for 15 days) that will not dry out the wound. Some clinicians suggest that EPIFLO® mimics the bloodstream in delivering the necessary metabolic energy to oxygen starved cells. EPIFLO® energizes ischemic cells to jump start the natural healing process. Oxygen helps form collagen, granulation tissue, new blood vessels and skin.

  • TransCu 02 Wound Care Device or EO2 System (EO2 Concepts) is a portable oxygen delivery system that provides a continuous flow of oxygen to a wound. Through a dressing attached to the device, oxygen is provided directly to the wound for 24 hours per day, 7 days a week. Oxygen is an important part in the wound healing process.
  • The EO2 System employs a TransCu 02 device which uses fuel cell technology to continuously generate pure humidified oxygen at adjustable flow rates from 3-15 ml/hr and delivers it directly to the wound bed environment within the OxySpur dressing. The OxySpur Oxygen Diffusion Dressing is an all-in-one dressing for medium to high exudating wounds. It’s design ensures even distribution of oxygen over the entire wound.

 

In 2008, Banks et. al. examined the effectiveness of the EpiFLO device as an adjunct treatment modality in chronic wound management. This study included 3 men with spinal cord injury (SCI), who each presented with a stage IV pressure ulcer in the pelvic region. They were treated with the EpiFLO device as an adjunct therapy. In Case 1, the patient was monitored for 9 weeks, whereas in Cases 2 and 3, the patients were monitored for 5 weeks. Healing was determined on a weekly basis by wound dimensions and volume, which were compared before and after the intervention. Comparison of pre- and post-treatment outcome measurements showed significant improvement with EPIFLO in each case. The authors concluded that EPIFLO seems to have had a positive effect on the healing rate of chronic pressure ulcers in individuals with SCI. The findings of this small case-series study need to be validated by well-designed studies.

 

In 2008, Bakri et. al. tested the hypothesis that local transdermal delivery of oxygen improves oxygenation in sternotomy wounds after cardiac surgery; the secondary hypothesis was that supplemental inspired oxygen improves sternal wound PsqO(2). After undergoing cardiopulmonary bypass, a total of 30 patients randomly received EPIFLO oxygen generators that provided oxygen at 6 ml/hr into an occlusive wound dressing, or identical-appearing inactive generators. EPIFLO oxygen generators that provided oxygen at 6 ml/hr into an occlusive wound dressing, or identical-appearing inactive generators. PsqO(2) and temperature were measured in the wound approximately 5-mm below the skin surface. PsqO(2) and arterial oxygen (Pao(2)) were measured 1 hr after intensive care unit admission (Fio(2) = 60 %) and on the 1st and 2nd post-operative mornings at Fio(2) of both 30 % and 50 % in random order. Data from 4 patients were excluded for technical reasons. Patient characteristics were similar in each group, as were type of surgery and peri-operative management. Increasing Fio(2) from 30 % to 50 % improved Pao(2) from 99 [84 to 116] to 149 [128 to 174] mm Hg (p < 0.001, mean [95 % CI]) and sternal wound PsqO(2) from 23 [16 to 33] to 27 [19 to 38] mm Hg (p < 0.001). In contrast, local oxygen delivery did not improve tissue oxygenation: 24 [14 to 41] versus 25 [16 to 41] mm Hg (p = 0.88). The authors concluded that additional inspired oxygen improved Pao(2) and sternal wound PsqO(2) after cardiopulmonary bypass surgery, and may, consequently, reduce infection risk. However, oxygen insufflated locally into an occlusive dressing did not improve wound PsqO(2) and, therefore, does not appear to be useful clinically in cardiac surgery patients to reduce sternal wound infections.

 

In 2009, Gordillo et.al. reviewed the evidence including in vitro, preclinical data and clinical data regarding the use of topical oxygen therapy in the treatment of lower extremity wounds. Randomized controlled trials are not yet reported and clearly necessary. The authors concluded the current body of evidence suggests that topical oxygen therapy may be considered as a second line of therapy for refractory wounds.

 

In 2010, Schreml et. al. noted that oxygen is a pre-requisite for successful wound healing due to the increased demand for reparative processes such as cell proliferation, bacterial defense, angiogenesis and collagen synthesis. The author stated that even though the role of oxygen in wound healing is not yet completely understood, many experimental and clinical observations have shown wound healing to be impaired under hypoxia. However, this review did not provide any clinical data to support the use of TCOT for wound healing.

 

In 2010, Blackman et. al. examined the clinical efficacy of a pressurized topical oxygen therapy (TWO(2)) device in outpatients (n = 28) with severe diabetic foot ulcers (DFU) referred for care to a community wound care clinic; and evaluated ulcer reoccurrence rates after 24 months. examined the clinical efficacy of a pressurized topical oxygen therapy (TWO(2)) device in outpatients (n = 28) with severe diabetic foot ulcers (DFU) referred for care to a community wound care clinic; and evaluated ulcer reoccurrence rates after 24 months. A total of 17 patients received TWO(2) 5 times per week (60-min treatment, pressure cycles between 5 and 50 mb) and 11 selected a silver-containing dressing changed at least twice per week (control). Patient demographics did not differ between treatment groups, but wounds in the treatment group were more severe, perhaps as a result of selection bias. Ulcer duration was longer in the treatment (mean of 6.1 months, SD 5.8) than in the control group (mean of 3.2 months, SD 0.4) and mean baseline wound area was 4.1 cm2 (SD 4.3) in the treatment and 1.4 cm2 (SD 0.6) in the control group (p = 0.02). Fourteen of 17 ulcers (82.4 %) in the treatment group and 5 of 11 ulcers (45.5 %) in the control group healed after a median of 56 and 93 days, respectively (p = 0.04). No adverse events were observed and there was no re-occurrence at the ulcer site after 24 months' follow-up in either group. The authors noted that although the absence of randomization and blinding may have under- or over-estimated the treatment effect of either group, the significant differences in treatment outcomes confirmed the potential benefits of TWO(2) in the management of difficult-to-heal DFUs. Moreover, they stated that clinical efficacy and cost-effectiveness studies as well as studies to elucidate the mechanisms of action of TWO(2) are needed.

 

In 2012, Woo et. al. evaluated the effectiveness of TCOT on chronic wound healing in 9 patients. After 4 weeks of treatment, mean wound surface area and wound infection check-list scores were significantly reduced. Signs of bacterial damage were also reduced. The authors concluded that findings from this study suggested TCOT may be beneficial in promoting chronic wound healing. These preliminary findings from a small pilot study need to be validated by well-designed studies.

 

In 2014 Brannick et. al. evaluated the diagnostic workup and treatment of a patient with a history of venous insufficiency and a large, painful non-healing ulcer and the use of continuous diffusion of oxygen therapy to facilitate healing, this case study involved a 53 year old female. The initial lower extremity physical exam revealed lower extremity hyperpigmentation and hemosiderin deposition in the bilateral gaiter area. Full thickness ulceration to the level of the dermis was present in the medial right ankle at the level of the medial malleolus. The ulcer measured 6.7 cm x 5.3 cm. Hypergranulation tissue was present at the wound base. The wound was well circumscribed and irregularly shaped with erythematous borders. Active serous drainage was present. There was no odor, no purulence and no gross signs of infection. Continuous diffusion of oxygen therapy as a treatment modality was implemented using TransCu O2 (EO2) concepts at 10ml/hr followed by a four layer compression dressing. The patient’s ulcer pain ranged from 3/10 to 8/10 on the VAS throughout the five month duration of the ulcer, requiring the patient to take pain medications when needed. The patient reported a pain level of only 2/10 after 20 days of continuous diffusion oxygen treatment and did not need additional pain medication at that time. At the 20 day mark the continuous diffusion oxygen therapy was temporarily discontinued as the patient was leaving town for a holiday. The patient returned to the clinic six days later (day 26 since beginning continuous therapy) and related 10/10 pain and difficulty sleeping. Continuous diffusion of oxygen treatment was resumed. Three days after restarting the therapy, the patient demonstrated adequate pain control and discontinued taking narcotic pain medications. The wound measurements taken at day 54 of treatment were 3.6 cm x 1.3 cm with mild hypergranulation. Complete wound closure occurred in 79 days with 100% epithelialization over the hypergranulation tissue. The authors concluded the treatment and management of chronic wounds can often be challenging. Oxygen is necessary for both cellular metabolism and host defense. Continuous diffusion of oxygen is a new therapy that is capable of delivering continuous oxygen without pressure and at a low flow rate. The low flow means it is unnecessary to have a humidifying adjunct to prevent desiccation of the wound. In addition, this device does not compromise the normal dressings and patient mobility. This case study demonstrates a successful use of continuous diffusion of oxygen in healing a chronic painful large wound. However, randomized controlled trials are needed to assess the effectiveness of this therapy.

 

In 2015, Couture et. al. conducted an unpublished retrospective study over a period of 16 months at a VA hospital to determine the safety and efficacy of using continuous diffusion of oxygen via the TransCu 02 in the treatment of lower extremity ulcerations that were difficult to heal. The average age of the wound at the start of continuous diffusion of oxygen was almost four months after the wounds were not responsive to other standard therapies. After excluding four patients for significant non-adherence and four patients to follow-up, 25 patients were included in the study. Continuous diffusion of oxygen both as an adjunctive therapy and as a solitary treatment was utilized in an outpatient wound care setting. The majority of the wounds 22 out of 25 were Wagner grade 1 ulcers on the foot, ankle or leg with granular wound bases. Twenty-two of the 25 patients had diabetes. The patients presented on a weekly basis on average for evaluation, offloading, dressing changes and sharp debridement. The research parameters consisted of the duration of treatment, whether the wound healed (full closure), patient adherence, wound size, percent improvement in wound size, age of wound at start of use, hemoglobin A1c level where applicable, other therapies utilized, significant comorbidities and wound locations. Seventeen of 25 patients experienced complete wound healing, a 68% healing rate. The average healing time was 7 weeks with an average wound size of 6.1 cm. Thirteen patients had concomitant advanced tissue application (Neox, Dermagraft, Apligaf and Grafix). The four patients that healed with continuous diffusion of oxygen therapy alone had an average healing time of four weeks. Out of the 25 patients, eight did not heal. Five of these patients had diabetes and the remaining three had ulcers due to PVD rather than diabetes. Three of these patients had no improvement during treatment, three had minimal improvement (5%-30%) and two had moderate improvement (60%-90%). The average wound size 8.5 cm was not dissimilar from those that healed. The average duration of continuous diffusion of oxygen therapy was just over nine weeks and it was determined that failed therapy was a wound that had not decreased in size over the course of at least three weeks. Three patients went to another facility for HBOT as they had already failed multiple wound healing modalities. Two patients had leg amputations due to severe PVD. The authors concluded the results of this retrospective study indicate that continuous diffusion of oxygen therapy, via TransCu 02 Oxygen Delivery System is a viable adjunctive option in the treatment of lower extremity ulcerations. Out study findings suggest this modality may be beneficial as a solitary treatment but further studies are necessary.

 

In 2015, Niederauer et. al. assessed the use of continuous diffusion of oxygen therapy to sham therapy in the treatment of diabetic foot ulcers in a prospective randomized double-blind multicenter study. One hundred subjects were enrolled and randomized with diabetic foot ulcers (DFU), 79% male aged 58.3 +/- 12.1 years to receive either active continuous diffusion of oxygen (CDO) therapy using an active CDO device, or an otherwise fully operational sham device that provided moist wound therapy (MWT) without delivering oxygen. Patients were followed to closure or 12 weeks whichever was sooner. Patients, treating physicians and independent evaluators were blinded to the study arm. All patients received identical offloading, dressings and follow-up. There were no significant differences in assessed descriptive characteristics between the treatment arms (P>0.5 for all). A significantly higher proportion of people healed in the active arm compared to sham (46% vs 22%, P = .02). This relative effect became greater in more chronic wounds (42.5% vs 13.5%, P = .006). Patients randomized to the active device experienced significantly faster rates of closure relative to the sham (P < .001). The authors concluded a significantly greater percentage of and rate of healing in patients receiving CDO therapy compared to a sham device providing standard would therapy. The study revealed that CDO therapy appears to have a similar or greater effect as the wound size increases. Furthermore, the relative effect of CDO therapy on more chronic wounds appears to be more pronounced as the wounds become more chronic. These results appear to indicate that the more a wound needs CDO therapy, the greater the apparent effect. We look forward to further works that may confirm or build on these data.

 

Summary

Based on review of the peer reviewed medical literature the evidence includes a randomized comparative controlled trial and numerous case studies. Although these study results may be promising in regards to topical continuous oxygen therapy (TCOT), also known as transdermal continuous oxygen wound therapy or continuous diffusion oxygen (CDO) therapy as a treatment modality for including but not limited to chronic non-healing wounds, further randomized comparative controlled studies are needed to assess the effectiveness of this therapy. Currently there are no society guidelines that provide recommendations regarding the use of topical continuous oxygen therapy (TCOT). The evidence is insufficient in determining the effects of this technology on net health outcomes.

 

Practice Guidelines and Position Statements

Undersea & Hyperbaric Medical Society (UHMS)

In 2014, the Undersea and Hyperbaric Medical Society (UHMS) issued hyperbaric oxygen therapy indication recommendations:

 

Indications for Hyperbaric Oxygen Therapy:

  • Air or gas embolism
  • Carbon monoxide poisoning and carbon monoxide poisoning complicated by cyanide poisoning
  • Clostridial myositis and myonecrosis (gas gangrene)
  • Crush injury, compartment syndrome and other acute traumatic ischemias
  • Decompression sickness
  • Arterial insufficiencies
    • Cranial 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)
  • Compromised grafts and flaps
  • Acute thermal burn injury
  • Idiopathic sudden sensorineural hearing loss

 

In 2015, the Undersea and Hyperbaric Medical Society (UHMS) issued a clinical practice guideline for the use of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers, that included the following recommendations:

  • In patients with Wagner Grade 2 or lower diabetic foot ulcers, we suggest against using hyperbaric oxygen therapy (very low-level evidence in support of HBO2, conditional recommendation)
  • In patients with Wagner Grade 3 or higher diabetic foot ulcers that have not shown significant improvement after 30 days of treatment, we suggest adding hyperbaric oxygen therapy to the standard of care to reduce the risk of major amputation and incomplete healing (moderate-level evidence, conditional recommendation)
  • In patients with Wagner Grade 3 or higher diabetic foot ulcers who have just had surgical debridement of an infected foot (e.g. partial toe or ray amputation; debridement of ulcer with underlying bursa, cicatrix or bone; foot amputation; incision and drainage of deep space abscess; or necrotizing soft tissue infection), we suggest adding acute post-operative hyperbaric oxygen therapy to the standard of care to reduce the risk of major amputation and incomplete healing (moderate -level of evidence, conditional recommendation)

 

In 2009, the Undersea and Hyperbaric Medical Society (UHMS) issued a position paper on the treatment of autism spectrum disorder (ASD) with hyperbaric oxygen therapy which states: There are few data upon which to base firm conclusions regarding the use of hyperbaric oxygen therapy for the treatment of ASD. “At this time, the UHMS cannot recommend the routine treatment of ASD with hyperbaric oxygen therapy outside appropriate comparative research protocols.”

 

The Undersea and Hyperbaric Medical Society (UHMS) issued a position paper on the treatment of multiple sclerosis with hyperbaric oxygen therapy: The synthesis of data presented suggests there is little evidence for the efficacy of hyperbaric oxygen therapy from trials with a low potential for bias. Most randomized controlled trials have failed to show any clinical benefit, while a minority have suggested some benefit. “At this time, the UHMS cannot recommend the routine treatment of multiple sclerosis with hyperbaric oxygen therapy outside appropriate comparative research protocols.”

 

In 2005, the Undersea and Hyperbaric Medical Society (UHMS) issued a position statement on topical oxygen for chronic wounds which states: Topical oxygen is not hyperbaric oxygen, and it is inaccurate and misleading to conflate the terms. Results of hyperbaric oxygen studies cannot be extrapolated to support topical oxygen treatments. To date, topical oxygen as a therapeutic strategy in wound healing is not adequately supported by scientific data. Those publications supporting its use are few in number and of a low level of scientific evidence. There are also reports, including the only randomized prospective trial, that show no benefit from topical oxygen. One study also documents toxicity to the healing wound with continued application. Before topical oxygen can be recommended as standard therapy for chronic wounds, it should undergo the same intensive review to which hyperbaric oxygen was subjected.

 

American College of Hyperbaric Medicine (ACHM)

In 2015, the following indications are approved by the American College of Hyperbaric Medicine and are reimbursable through CMS:

  • Air or gas embolism
  • Acute carbon monoxide intoxication
  • Clostridial myositis and myonecrosis (gas gangrene)
  • Crush injury, compartment syndrome and acute traumatic ischemias
  • Decompression illness
  • Enhancement of healing in select problem wounds
  • Extreme anemia
  • Intracranial abscess
  • Necrotizing soft tissue infections
  • Osteomyelitis (refractory)
  • Delayed radiation injury (soft tissue and bony necrosis)
  • Skin flaps and grafts (compromised)

 

If sufficient data demonstrates that hyperbaric oxygen therapy is associated with a favorable risk-benefit ratio for an indication, which is not currently on the approved list from the Centers of Medicare and Medicaid, The Undersea and Hyperbaric Medical Society or a Commercial Insurance Carrier, the ACHM will endorse the application of hyperbaric therapy for the supported indication. Indications that meet these criteria and are supported by the ACHM as appropriate for hyperbaric oxygen therapy include:

  • Acute thermal burns
  • Acute central retinal artery occlusion
  • Acute frost bite
  • Actinomycosis (refractory and recalcitrant)
  • Brown recluse spider bites
  • Idiopathic sudden sensorineural hearing loss

 

The ACHM supports the treatment of patients with non-approved indications only in a research setting using a protocol that has been approved by an Institutional Review Board. The ACHM supports the continued performance of well-designed clinical trials in these areas, especially those that are prospective, randomized, controlled trials. The ACHM does not support the treatment of non-approved conditions for financial gain, without investigational treatment protocols. College members who intentionally mislead the patient or family into believing that hyperbaric therapy is an approved indication or is supported by peer reviewed literate will be dismissed from the ACHM.

 

The Tenth European Consensus Conference on Hyperbaric Medicine

In 2016, the tenth European Consensus Conference on Hyperbaric Medicine issued recommendations for accepted and non-accepted clinical indications of hyperbaric oxygen treatment that included the following:

 

Level of Evidence: Grade A = High level of evidence; Grade B = Moderate level of evidence; Grade C = Low level of evidence; Grade D = Very low level of evidence.

 

Strength of Recommendation: Level 1 = strong recommendation (we recommend); Level 2 = weak recommendation (we suggest); Level 3 = neutral recommendation (would be reasonable); no recommendation = no agreement was reached by the group of experts.

 

ConditionLevel of EvidenceStrength of Recommendation
Carbon monoxide (CO) poisoning Moderate level of evidence Strong recommendation (we recommend)
Open fractures with crush injury Moderate level of evidence Strong recommendation (we recommend)
Prevention of osteoradionecrosis after dental extraction Moderate level of evidence Strong recommendation (we recommend)
Osteoradionecrosis (mandible) Moderate level of evidence Strong recommendation (we recommend)
Soft tissue radionecrosis (cystitis, proctitis) Moderate level of evidence Strong recommendation (we recommend)
Decompression illness Low level of evidence Strong recommendation (we recommend)
Gas embolism Low level of evidence Strong recommendation (we recommend)
Anerobic or mixed bacterial infections Low level of evidence Strong recommendation (we recommend)
Sudden deafness Moderate level of evidence Strong recommendation (we recommend)
Diabetic foot lesions Moderate level of evidence Weak recommendation (we suggest)
Femoral head necrosis Moderate level of evidence Weak recommendation (we suggest)
Compromised skin grafts and musculocutaneous flaps Low level of evidence Weak recommendation (we suggest)
Central retinal artery occlusion (CRAO) Low level of evidence Weak recommendation (we suggest)
Crush injury without fracture Low level of evidence Weak recommendation (we suggest)
Osteoradionecrosis (bones other than mandible) Low level of evidence Weak recommendation (we suggest)
Radio-induced lesions of soft tissues (other than cystitis and proctitis) Low level of evidence Weak recommendation (we suggest)
Surgery and implant in irradiated tissue (preventative treatment) Low level of evidence Weak recommendation (we suggest)
Ischaemic ulcers Low level of evidence Weak recommendation (we suggest)
Refractory chronic osteomyelitis Low level of evidence Weak recommendation (we suggest)
Burns 2nd degree more than 20% BSA Low level of evidence Weak recommendation (we suggest)
Pneumatosis cystoides intestinalis Low level of evidence Weak recommendation (we suggest)
Neuroblastoma, Stage IV Low level of evidence Weak recommendation (we suggest)
Brain injury (acute and chronic TBI, chronic stroke, post anoxic encephalopathy) in highly selected patients Low level of evidence Neutral recommendation (would be reasonable)
Radio-induced lesions of larynx Low level of evidence Neutral recommendation (would be reasonable)
Radio-induced lesions of the CNS Low level of evidence Neutral recommendation (would be reasonable)
Post-vascular procedure reperfusion syndrome
Limb replantation
Selected non-healing wounds secondary to systemic processes
Sickle cell disease Low level of evidence Neutral recommendation (would be reasonable)
Interstitial cystitis Low level of evidence Neutral recommendation (would be reasonable)

 

American Academy of Otolaryngology-Head and Neck Surgery

In 2012, the American Academy of Otolaryngology – Head and Neck Surgery published a clinical guideline on treatment of sudden hearing loss. The guideline includes a statement that HBOT may be considered a treatment option for patients who present within 3 months of a diagnosis of ISSNHL. 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.”

 

Society for Vascular Surgery in Collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine

In 2016, the Society for Vascular Surgery in Collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine issued a clinical practice guideline for the management of diabetic foot. The guideline includes the following: “For diabetic foot ulcers (DFUs) that fail to demonstrate improvement (>50% wound area reduction) after a minimum of 4 weeks of standard wound therapy, the committee recommends adjunctive wound therapy options. These include negative pressure therapy, biologics (platelet-derived growth factor, living cellular therapy, extracellular matrix products, amniotic membrane products), and hyperbaric oxygen therapy. Choice of adjuvant therapy is based on clinical findings, availability of therapy, and cost-effectiveness; there is no recommendation on ordering of therapy choice. Re-evaluation of vascular status, infection control, and off-loading is recommended to ensure optimization before initiation of adjunctive wound therapy.” (Grade 1B)

 

The guideline also states: “In patients with diabetic foot ulcer (DFU) who have adequate perfusion that fails to respond to 4 to 6 weeks of conservative management, the committee suggests hyperbaric oxygen therapy.” (Grade 2B)

 

Prior Approval:

Not applicable

 

Policy:

Systemic Hyperbaric Oxygen Therapy (HBOT) (99183, G0277)

Systemic hyperbaric oxygen therapy (HBOT) may be considered medically necessary in the treatment of the following conditions:

  • Decompression sickness
  • Acute carbon monoxide poisoning
  • Gas gangrene(i.e., clostridial myositis and myonecrosis)
  • Osteomyelitis, refractory to conventional medical and surgical management
  • Compromised skin grafts or flaps
  • Prophylactic pre-operative and post-operative treatment for patients undergoing dental surgery (non-implant-related) of an irradiated jaw
  • Chronic non-healing wounds
  • Profound/severe anemia with exceptional blood loss: only when blood transfusion is impossible or must be delayed
  • Acute cyanide poisoning
  • Air or gas embolism
  • Progressive necrotizing infections (necrotizing fascitis)
  • Acute peripheral arterial insufficiency
  • Acute traumatic ischemia e.g.crush injuries, reperfusion injury, compartment syndrome
  • Actinomycosis, only when refractory to antibiotics and surgical treatment
  • Diabetic wounds of the lower extremities meeting all of the following criteria:
    • Type I or II diabetes mellitus
    • Wound classification as Wagner grade III or higher
    • History of failed standard wound therapy as defined below
    • Initiation of HBO: Covered as adjunct therapy when at least 30 consecutive days of standard wound therapy alone has produced no measureable signs of healing. HBO therapy must be used in addition to standard diabetic wound care measures such as: assessment of vascular status; correction of vascular problems in the affected limb if possible; optimization of nutritional status; optimization of glucose control; debridement by means to remove devitalized tissue; maintenance of a clean moist bed of granuation tissue with appropriate moist dressings; appropriate off loading; and necessary treatment to resolve any infection that might be present.
    • OR
    • Continued HBO: If measurable signs of wound healing are evident after a 30 day period of treatment with HBO therapy and standard wound therapy. If no measurable signs of wound healing are evidenced after the 30 day period, continued treatment with HBO therapy is considered not medically necessary and, therefore, not covered.
  • Idiopathic sudden sensorineural hearing loss (defined as a hearing loss of at least 30dB occurring within 3 days over at least 3 contiguous frequencies) and when treatment is initiated within 14 days of symptom onset
  • Central retinal artery obstruction when treatment is initiated within 24 hours of vision loss
  • Delayed radiation injuries (soft tissue and bony necrosis) (e.g. induced tissue injury, especially in gynecologic malignancies; cystitis, radiation enteritis, proctitis and osteoradionecrosis)
  • Acute thermal burns, deep second degree or third degree in nature
  • Intracranial abscess (i.e. ceregral abscess, subdural empyma, and epidural empyma)

 

Systemic hyperbaric oxygen therapy (HBOT) is considered investigational for all other indications not listed above, including, but not limited to, the following:

  • Acute carbon tetrachloride poisoning
  • Acute cerebral edema
  • Acute coronary syndromes and as adjunct to coronary artery interventions including but not limited to percutaneous coronary interventions and cardiopulmonary bypass
  • Acute frost bite
  • Acute thermal burns (except as described above)
  • AIDS/HIV
  • Alzheimer’s disease
  • Asthma
  • Autism spectrum disorder (ASD)
  • Bell’s palsy
  • Bone graft
  • Brain injury, acute and traumatic brain injury (TBI)
  • Brown recluse spider bite (necrotizing arachnidism)
  • Cerebral palsy
  • Cerebrovascular disease, acute (thrombotic or embolic) or chronic
  • Chronic arm lymphedema following radiotherapy for cancer
  • Crohn’s disease (includes fistulizing Crohn’s disease)
  • Demyelinating disease including but not limited to multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS)
  • Depression
  • Early treatment (beginning at the completion of radiation therapy) to reduce side effects of radiation therapy
  • Fracture healing
  • Heart disease
  • Hepatitis
  • Hydrogen sulfide poisoning
  • Idiopathic femoral head necrosis
  • Idiopathic sensorineural hearing loss (other than described above)
  • Intra-abdominal abcesses
  • In-vitro fertilization
  • Lepromatous leprosy
  • Meningitis
  • Migraine headaches/headaches
  • Motor dysfunction associated with stroke
  • Neurologic conditions
  • Parkinson’s disease
  • Preconditioning to improve myocardial function and/or reduce postoperative complications in patients undergoing coronary artery bypass grafting (CABG)
  • Pseudomembranous colitis (antimicrobial agent-induced colitis)
  • Pyoderma gangrenosum
  • Radiation induced injury of head and neck
  • Refractory mycoses (other than actinomycosis as described above)
  • Spinal cord injury
  • Sports injury
  • Tumor sensitization for cancer treatments including but not limited to radiotherapy or chemotherapy

 

Based on review of the peer review medical literature, the literature searches did not identify sufficient evidence to support the use of systemic hyperbaric oxygen therapy (HBOT). There is insufficient evidence establishing that systemic HBOT is more effective than conventional therapies. Further randomized controlled trials (RCTs) are needed to include double blind comparisons of HBOT to sham HBOT. The evidence is insufficient in determining the effects of the technology on net health outcomes.

 

Topical Hyperbaric Oxygen Therapy (A4575)

Topical hyperbaric oxygen therapy is considered investigational for all indications.

 

Based on review of the peer reviewed medical literature, there is minimal and insufficient data to conclude that the use of topical hyperbaric oxygen therapy results in improved net health outcomes. Further randomized clinical studies are warranted to examine the value of this therapy. The evidence is insufficient in determining the effects of the technology on net health outcomes.

 

Topical Continuous Oxygen Therapy (TCOT) (E0446)

Topical continuous oxygen therapy (TCOT), also known as transdermal continuous oxygen wound therapy or continuous diffusion oxygen (CDO) wound therapy, including but not limited to the following is considered investigational for all indications.

  • EPIFLO Transdermal Continuous Oxygen Therapy
  • TransCu 02 Wound Care Device or E02

 

Based on review of the peer reviewed medical literature the evidence includes a randomized comparative controlled trial and numerous case studies. Although these study results may be promising in regards to topical continuous oxygen therapy (TCOT) (also known as transdermal continuous oxygen wound therapy or continuous diffusion oxygen (CDO) therapy) as a treatment modality including but not limited to chronic non-healing wounds, further randomized comparative controlled studies are needed to assess the effectiveness of this therapy. Currently there are no society guidelines that provide recommendations regarding the use of topical continuous oxygen therapy (TCOT). The evidence is insufficient in determining the effects of this technology on net health outcomes.

 

Policy Guidelines

Wagner Grade Wound Classification

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

  • Grade 0 - No open lesion
  • Grade I - Superficial ulcer, not involving subcutaneous tissue
  • Grade II - Deep ulcer with penetration through the subcutaneous tissue potentially exposing tendon, bone, or joint capsule
  • Grade III - Deep ulcer penetrates deeper than Grade II and has evidence of abscess (pus) or osteomyelitis (bone infection)
  • Grade IV - Gangrene present in the toe(s)
  • Grade V - Gangrene of the foot requiring amputation

 

Definitions

Thermal Burn: The depth of the burn injury is related to contact temperature, duration of contact of the external heat source, and the thickness of the skin. Because the thermal conductivity of skin is low, most thermal burns involve the epidermis and part of the dermis. The most common thermal burns are associated with flames, hot liquid, hot solid objects and steam. The depth of the burn largely determines the healing potential and the need for surgical grafting.

 

Classification

The traditional classification of burns as first, second, third degree was replaced by a system reflecting the need for surgical intervention. The term term fourth degree is still used to describe the most severe burns. The current designations of burn depth are classified as the following:

  • Superficial or epidermal (first degree): superficial or epidermal burns involve only the epidermal layer of skin.
  • Partial thickness (second degree): partial thickness burns involve the epidermis and portions of the dermis. They are characterized as either superficial or deep.
    • Superficial: These burns characteristically form blisters within 24 hours between the epidermis and dermis.
    • Deep: These burns extend into the deeper dermis and are characteristically different from superficial partial thickness burns. Deep burns damage hair follicles and glandular tissue.
  • Full thickness (third degree): these burns extend through and destroy all layers of the dermis and often injure the underlying subcutaneous tissues.
  • Fourth degree are deep and potentially life threatening injuries that extend through the skin into underlying tissues such as the fascia, muscle and/or bone.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes. 

  • 99183  Physician or other qualified health care professional, attendance and supervision of hyperbaric oxygen therapy, per session  
  • A4575  Topical hyperbaric oxygen chamber, disposable
  • E0446  Topical oxygen delivery system, NOS, includes all supplies and accessories 
  • G0277  Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval

 

Selected References:

  • Landau  Z. Topical hyperbaric oxygen and low energy laser for the treatment of diabetic foot ulcers. Archives of Orthopaedic and Trauma Surgery 1998;117:156-158
  • Leslie CA,  Sapico FL, Ginunas VJ, Adkins RH.  Randomized controlled trial of topical hyperbaric oxygen for treatment of diabetic foot ulcer. Diabetes Care 1988; 11:111-115. 
  • Colombel JF, Bouault JM, Lesage X, Zavadil P, Quandalle P, Cortot A. Hyperbaric oxygenation in severe perineal Crohn's disease. Diseases of the Colon and Rectum 1995; 38:609-614. 
  • Lambert PM, Intriere N, Eichstaedt R. Management of dental extractions in irradiated jaws: A protocol with hyperbaric oxygen therapy. Journal of Oral and Maxillofacial Surg 1997; 55:268-274. 
  • Sipahi AM, Damiao AOMC, de Sousa MM,  Barbutti RC,  Trivellato S,  Esteves C, D'Agostino M,  Laudanna AA. Hyperbaric Oxygen: A new alternative in the treatment of perianal Crohns disease. Revista do Hospital das Clinicas; Faculdade de Medicina de Universidade de Sao Paulo. 1996; 51(5):189-191.
  • Wilkerson R,  Paull W, Coville FV.  Necrotizing Fasciitis; review of the literature and case report. Clinical Orthopedics and related research March 1987;216: 187-192.
  • Bakker D. Selected Aerobic and Anaerobic Soft Tissue Infections. In E.P. Kindwall and H.T. Whelan ( eds.), Hyperbaric Medicine Practice (pp. 575-597) Flagstaff, AZ: Best Pub. Co.
  • Gordillo GM, Sen CK. Revisiting the essential role of oxygen in wound healing. Am J Surg. 186 (2003) 259-263. 
  • Sheikh AY, Gibson JJ, Rollins MD, Hopf HW, Hussain Z, Hunt TK. Effect of Hyperoxia on Vascular Endothelial Growth Factor Levels in a Wound Model. Arch Surg. 2000;135:1293-1297.
  • ECRI. Hyperbaric Oxygen Therapy for Brain Injury, Stroke, Multiple Sclerosis, Cerebral Palsy, and Autism. Plymouth Meeting (PA): ECRI 2008 January 8. 13p. (ECRI Hotline Response).
  • ECRI. Hyperbaric Oxygen Therapy for Chronic Wound Healing. Plymouth Meeting (PA): ECRI 2007 August 23. 11p. (ECRI Hotline Response).
  • ECRI. Hyperbaric Oxygen Therapy for Soft Tissue Radionecrosis. Plymouth Meeting (PA):ECRI 2008 January 8. 10p. (ECRI Hotline Response).
  • ECRI. Hyperbaric Oxygen Therapy for Hemorrhagic Cystitis. Plymouth Meeting (PA): ECRI 2007 September 20. 7p. (ECRI Hotline Response).
  • Rossignol DA, Rossignol LW, Smith S et al. Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind controlled trial. BMC Pediatrics 2009; 9:21.
  • Bennett M, Hart B. UHMS Position Paper Treatment of children with autism spectrum disorder with hyperbaric oxygen therapy. December 5, 2009.
  • 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 Feb;28(2):186-90. doi: 10.1111/j.1464-5491.2010.03185.x.
  • Londahl M, Katzman P, Hammarlund C et al. Relationship between ulcer healing after hyperbaric oxygen therapy and transcutaneous oximetry, toe blood pressure and ankle-brachial index in patients with diabetes and chronic foot ulcers. Diabetologia. 2001 Jan;54(1):65-8. Epub 2010 Oct 9.
  • Eskes A, Ubbink DT, Lubbers M et al. Hyperbaric oxygen therapy for treating acute surgical and traumatic wounds. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD008059.
  • 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 Aug;68(8):1732-9. Epub 2010 May 20.
  • Gothard L, Haviland J, Bryson P et al. Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphedema after radiotherapy for cancer. Radiother Oncol. 2010 Oct;97(1):101-7. Epub 2010 May 31.
  • Camporesi EM, Vezzani G, Bosco G et al. Hyperbaric oxygen therapy in femoral head necrosis. J Arthroplasty. 2010 Sep;25(6 Suppl):118-23. Epub 2010 Jul 15.
  • Cope A, Eggert JV, O'Brien E. Retinal artery occlusion: visual outcome after treatment with hyperbaric oxygen. Diving Hyperb Med. 2011 Sep; 41(3):135-8.
  • Butler FK Jr, Hagan C, Murphy-Lavoie H. Hyperbaric oxygen therapy and the eye. Undersea Hyperb Med. 2008 Sep-Oct; 35(5):333-87.
  • Menzel-Severing J, Siekmann U, Weinberger A et al. Early hyperbaric oxygen treatment for nonarteritic central retinal artery obstruction. Am J Ophthalmol. 2012 Mar; 153(3):454-59.e2. Epub 2011 Oct 11.
  • Stachler RJ, Chandrasekhar SS, Archer SM et al. Clinical practice guideline: sudden hearing loss. Otolaryngol Head Neck Surg. 2012 Mar; 146(3 Suppl):S1-35.
  • Murphy-Lavoie H, Piper S, Moon RE et al. Hyperbaric oxygen therapy for idiopathic sudden sensorineural hearing loss. Undersea Hyperb Med 2012; 39(3):777-92.
  • Craighead P, Shea-Budgell MA, Nation J et al. Hyperbaric oxygen therapy for late radiation tissue injury in gynecologic malignancies. Curr Oncol. 2011 Oct; 18(5):220-7.
  • Allen S, Kilian C, Phelps J et al. The use of hyperbaric oxygen for treating delayed radiation injuries in gynecologic malignancies: a review of literature and report of radiation injury incidence. Support Care Cancer. 2012 Jan 14. [Epub ahead of print].
  • Bennett MH, Feldmeier J, Smee R et al. Hyperbaric oxygenation for tumor sensitization to radiotherapy. Cochrane Database Syst Rev. 2012 Apr 18; 4: CD005007.
  • Kranke P, Bennett MH, Martyn-St. James M et al. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev. 2012 Apr 18; 4:CD004123.
  • Li Y, Dong H, Chen M et al. Preconditioning with repeated hyperbaric oxygen induces myocardial and cerebral protection in patients undergoing coronary artery bypass graft surgery: a prospective, randomized, controlled clinical trial. J Cardiothorac Vasc Anesth. 2011 Dec; 25(6):908-16. Epub 2011 Aug 25.
  • Jeysen ZY, Gerard L, levant G et al. Research report: the effects of hyperbaric oxygen preconditioning on myocardial biomarkers of cardioprotection in patients having coronary artery bypass graft surgery. Undersea Hyperb Med. 2011 May-Jun; 38(3):175-85.
  • Holland NJ, Bernstein JM, Hamilton JW. Hyperbaric oxygen for Bell's palsy. Cochrane Database Syst Rev 2012; 2:CD007288.
  • Feldmeier JJ, Hopf HW, Warriner III RA et al. UHMS position statement: topical oxygen for chronic wounds. Undersea Hyperb Med. 2005 May-Jun; 32(3): 157-68.
  • Bennett MH, Lehm JP, Jepson N. Hyperbaric oxygen therapy for acute coronary syndrome. Cochrane Database of Syst Rev. 2011; 8:CD004818.
  • Ghanizadeh A. Hyperbaric oxygen therapy for treatment of children with Autism: a systematic review of randomized trials. Med Gas Res 2012; 2:13.
  • Rossignol DA, Bradstreet JJ, Van Dyke K et al. Hyperbaric oxygen treatment in autism spectrum disorders. Med Gas Res 2012; 2(1):16. 
  • ECRI Institute: Windows on Medical Technology Policy Statement, Hyperbaric Oxygen Therapy for Chronic Wound Healing
  • ECRI Institute-Hyperbaric Oxygen Therapy for Chronic Wound Healing, published 04/01/2011
  • ECRI Institute-Topical Oxygen Therapy for Chronic Wound Healing, published 03/29/2011
  • Hypebaric oxygen therapy for Brain Injury, Stroke, Multiple Sclerosis, Cerebral Palsy and Autism, published 03/07/2011
  • Undersea and Hyperbaric Medical Society Hyperbaric Oxygen Therapy Indications.
  • American College of Hyperbaric Medicine FAQ What are the Approved Indications for Hyperbaric Oxygen Therapy.
  • ECRI Institute: Transcutaneous Oxygen Monitoring for Managing Chronic Wounds, Published 02/05/2013
  • FDA Consumer Health Information. Hyperbaric Oxygen Therapy: Don’t be Mislead.
  • Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD) for Hyperbaric Oxygen Therapy (20.29).
  • Agency of Healthcare Research and Quality Evidence Report/Technology Assessment, Number 85, Hyperbaric Oxygen Therapy for Brain Injury, Cerebral Palsy and Stoke. AHRQ Pub. No. 03-E049 September 2003.
  • National Guideline Clearinghouse Clinical Practice Guideline: Sudden Hearing Loss. March 2012.
  • National Guideline Clearinghouse Traumatic Brain Injury Medical Treatment Guidelines. November 2012.
  • National Guideline Clearinghouse Guideline for Primary Care Management of Headache in Adults. July 2012.
  • National Guideline Clearinghouse Crohn’s Disease: Management in Adults, Children and Young People. NICE clinical guideline; no. 152, October 2012.
  • National Guideline Clearinghouse Management of Crohn’s Disease in Adults. Practice Parameters Committee of American College of Gastroenterology, Management of Crohn’s Disease in Adults. Am J Gastroenterol, 2009 Feb; 104(2):465, 484.
  • National Institute for Health and Care Excellence (NICE), Clinical Guideline 170. Autism, The Management and Support of Children and Young People on the Autism Spectrum. Issued August 2013.
  • Undersea and Hyperbaric Medical Society (UHMS) Position Statement: Topical Oxygen for Chronic Wounds. UHM 2005, Vol. 32, No. 3.
  • Transcutaneous Oximetry in Clinical Practice: Consensus Statements from an Expert Panel Based on Evidence. UHM 2009, Vol. 36, No. 1.
  • PubMed Hyperbaric Oxygen Therapy for Multiple Sclerosis
  • American Family Physicians, Evaluation and Treatment of Brown Recluse Spider Bites, Am Fam Physician 2005 Oct 1; 72(7):1372-1376
  • Leslie CA, Sapico FL, Ginunas VJ, et al. Randomized controlled trial of topical hyperbaric oxygen for treatment of diabetic foot ulcers. Diabetes Care. Feb 1988;11(2):111-115. PMID 3289861
  • Kranke P, Bennett MH, Martyn-St James M, et al. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev. 2012;4:CD004123. PMID 22513920
  • O'Reilly D, Pasricha A, Campbell K, et al. Hyperbaric oxygen therapy for diabetic ulcers: systematic review and meta-analysis. Int J Technol Assess Health Care. Jul 2013;29(3):269-281. PMID 23863187
  • Eskes A, Vermeulen H, Lucas C, et al. Hyperbaric oxygen therapy for treating acute surgical and traumatic wounds. Cochrane Database Syst Rev. 2013;12:CD008059. PMID 24343585
  • Dauwe PB, Pulikkottil BJ, Lavery L, et al. Does hyperbaric oxygen therapy work in facilitating acute wound healing: a systematic review. Plast Reconstr Surg. Feb 2014;133(2):208e-215e. PMID 24469192
  • Buckley NA, Juurlink DN, Isbister G, et al. Hyperbaric oxygen for carbon monoxide poisoning. Cochrane Database Syst Rev. 2011(4):CD002041. PMID 21491385
  • 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. PMID 18254025
  • Bennett MH, Feldmeier J, Hampson N, et al. Hyperbaric oxygen therapy for late radiation tissue injury. Cochrane Database Syst Rev. 2012;5:CD005005. PMID 22592699
  • Freiberger JJ, Padilla-Burgos R, McGraw T, et al. What is the role of hyperbaric oxygen in the management of bisphosphonate-related osteonecrosis of the jaw: a randomized controlled trial of hyperbaric oxygen as an adjunct to surgery and antibiotics. J Oral Maxillofac Surg. Jul 2012;70(7):1573-1583. PMID 22698292  
  • 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. Feb 2004;27(2):91-97. PMID 15095953
  • 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. Feb 2003;26(2):114-121. PMID 12718388
  • Bennett MH, Stanford RE, Turner R. Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union. Cochrane Database Syst Rev. 2012;11:CD004712. PMID 23152225
  • 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. Jun 2006;117(7 Suppl):175S-190S; discussion 191S-192S. PMID 16799386
  • Levett D, Bennett MH, Millar I. Adjunctive hyperbaric oxygen for necrotizing fasciitis. Cochrane Database Syst Rev. 2015;1:CD007937. PMID 25879088
  • Jallali N, Withey S, Butler PE. Hyperbaric oxygen as adjuvant therapy in the management of necrotizing fasciitis. Am J Surg. Apr 2005;189(4):462-466. PMID 15820462
  • George ME, Rueth NM, Skarda DE, et al. Hyperbaric oxygen does not improve outcome in patients with necrotizing soft tissue infection. Surg Infect (Larchmt). Feb 2009;10(1):21-28. PMID 18991520
  • Bennett MH, Lehm JP, Jepson N. Hyperbaric oxygen therapy for acute coronary syndrome. Cochrane Database Syst Rev. 2011(8):CD004818. PMID 21833950
  • Bennett MH, Weibel S, Wasiak J, et al. Hyperbaric oxygen therapy for acute ischaemic stroke. Cochrane Database Syst Rev. 2014;11:CD004954. PMID 25387992
  • Efrati S, Fishlev G, Bechor Y, et al. Hyperbaric oxygen induces late neuroplasticity in post stroke patients--randomized, prospective trial. PLoS One. 2013;8(1):e53716. PMID 23335971
  • Holland NJ, Bernstein JM, Hamilton JW. Hyperbaric oxygen therapy for Bell's palsy. Cochrane Database Syst Rev. 2012;2:CD007288. PMID 22336830
  • Bennett MH, Trytko B, Jonker B. Hyperbaric oxygen therapy for the adjunctive treatment of traumatic brain injury. Cochrane Database Syst Rev. 2012;12:CD004609. PMID 23235612
  • Wolf G, Cifu D, Baugh L, et al. The effect of hyperbaric oxygen on symptoms after mild traumatic brain injury. J Neurotrauma. Nov 20 2012;29(17):2606-2612. PMID 23031217
  • Cifu DX, Walker WC, West SL, et al. Hyperbaric oxygen for blast-related postconcussion syndrome: three-month outcomes. Ann Neurol. Feb 2014;75(2):277-286. PMID 24255008
  • Miller RS, Weaver LK, Bahraini N, et al. Effects of hyperbaric oxygen on symptoms and quality of life among service members with persistent postconcussion symptoms: a randomized clinical trial. JAMA Intern Med. Jan 2015;175(1):43-52. PMID 25401463
  • Marois P, Mukherjee A, Ballaz L. Hyperbaric Oxygen Treatment for Persistent Postconcussion Symptoms-A Placebo Effect? JAMA Intern Med. Jul 1 2015;175(7):1239-1240. PMID 26146912
  • Dulai PS, Gleeson MW, Taylor D, et al. Systematic review: The safety and efficacy of hyperbaric oxygen therapy for inflammatory bowel disease. Aliment Pharmacol Ther. Jun 2014;39(11):1266-1275. PMID 24738651
  • Pagoldh M, Hultgren E, Arnell P, et al. Hyperbaric oxygen therapy does not improve the effects of standardized treatment in a severe attack of ulcerative colitis: a prospective randomized study. Scand J Gastroenterol. Sep 2013;48(9):1033-1040. PMID 23879825
  • Murphy-Lavoie H, Piper S, Moon RE, et al. Hyperbaric oxygen therapy for idiopathic sudden sensorineural hearing loss. Undersea Hyperb Med. May-Jun 2012;39(3):777-792. PMID 22670557
  • Bennett MH, Kertesz T, Perleth M, et al. Hyperbaric oxygen for idiopathic sudden sensorineural hearing loss and tinnitus. Cochrane Database Syst Rev. 2012;10: CD004739. PMID 23076907
  • Cvorovic L, Jovanovic MB, Milutinovic Z, et al. Randomized prospective trial of hyperbaric oxygen therapy and intratympanic steroid injection as salvage treatment of sudden sensorineural hearing loss. Otol Neurotol. Aug 2013;34(6):1021-1026. PMID 23820795
  • Bennett M, Feldmeier J, Smee R, et al. Hyperbaric oxygenation for tumour sensitisation to radiotherapy. Cochrane Database Syst Rev. 2005(4):CD005007. PMID 16235387
  • Van Voorhis BJ, Greensmith JE, Dokras A, et al. Hyperbaric oxygen and ovarian follicular stimulation for in vitro fertilization: a pilot study. Fertil Steril. Jan 2005;83(1):226-228. PMID 15652917
  • Bennett M, Best TM, Babul S, et al. Hyperbaric oxygen therapy for delayed onset muscle soreness and closed soft tissue injury. Cochrane Database Syst Rev. 2005(4):CD004713. PMID 16235376
  • Ghanizadeh A. Hyperbaric oxygen therapy for treatment of children with autism: a systematic review of randomized trials. Med Gas Res. 2012;2:13. PMID 22577817
  • Rossignol DA, Rossignol LW, Smith S, et al. Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial. BMC Pediatr. 2009;9:21. PMID 19284641
  • Sampanthavivat M, Singkhwa W, Chaiyakul T, et al. Hyperbaric oxygen in the treatment of childhood autism: a randomised controlled trial. Diving Hyperb Med. Sep 2012;42(3):128-133. PMID 22987458
  • Steele J, Matos LA, Lopez EA, et al. A Phase I safety study of hyperbaric oxygen therapy for amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. Dec 2004;5(4):250-254. PMID 15799556
  • Lacey DJ, Stolfi A, Pilati LE. Effects of hyperbaric oxygen on motor function in children with cerebral palsy. Ann Neurol. Nov 2012;72(5):695-703. PMID 23071074
  • Collet JP, Vanasse M, Marois P, et al. Hyperbaric oxygen for children with cerebral palsy: a randomized multicentre trial. HBO-CP Research Group. Lancet. Feb 24 2001;357(9256):582-586. PMID 11558483
  • Xiao Y, Wang J, Jiang S, et al. Hyperbaric oxygen therapy for vascular dementia. Cochrane Database Syst Rev.2012;7:CD009425. PMID 22786527
  • Spiegelberg L, Djasim UM, van Neck HW, et al. Hyperbaric oxygen therapy in the management of radiationinduced injury in the head and neck region: a review of the literature. J Oral Maxillofac Surg. Aug 2010;68(8):1732-1739. PMID 20493616
  • Camporesi EM, Vezzani G, Bosco G, et al. Hyperbaric oxygen therapy in femoral head necrosis. J Arthroplasty. Sep 2010;25(6 Suppl):118-123. PMID 20637561
  • Bennett MH, French C, Schnabel A, et al. Normobaric and hyperbaric oxygen therapy for migraine and cluster headache. Cochrane Database Syst Rev. 2008(3):CD005219. PMID 18646121
  • Peng Z, Wang S, Huang X, et al. Effect of hyperbaric oxygen therapy on patients with herpes zoster. Undersea Hyperb Med. Nov-Dec 2012;39(6):1083-1087. PMID 23342765
  • Yildiz S, Kiralp MZ, Akin A, et al. A new treatment modality for fibromyalgia syndrome: hyperbaric oxygen therapy. J Int Med Res. May-Jun 2004;32(3):263-267. PMID 15174219
  • Efrati S, Golan H, Bechor Y, et al. Hyperbaric oxygen therapy can diminish fibromyalgia syndrome – prospective clinical trial. PLoS One. 2015;10(5):e0127012. PMID 26010952
  • Hyperbaric Oxygen Therapy for Adults with Mental Illness: A Review of the Clinical Effectiveness. Ottawa ON: 2014 Canadian Agency for Drugs and Technologies in Health; 2014.
  • Bennett M, Heard R. Hyperbaric oxygen therapy for multiple sclerosis. Cochrane Database Syst Rev.2004(1):CD003057. PMID 14974004
  • Huang ET et al. A Clinical Practive Guideline for the Use of Hyperbaric Oxygen Therapy in the Treatment of Diabetic Foot Ulcers 2015; . Accessed July 1, 2015.
  • American Academy of Otolaryngology-Head and Neck Surgery Clinical practice guideline: sudden hearing loss. 2012; Accessed June 8, 2015.
  • UpToDate Hyperbaric Oxygen Therapy. C Crawford Mechem M.D., FACEP, Scott Manaker M.D., PhD. Topic last updated August 27, 2014.
  • UpToDate Smoke Inhalation. Jess Mandel M.D. Topic last updated December 8, 2014.
  • UpToDate. Carbon Monoxide Poisoning. Peter F Clardy M. D., Scott Manaker M.D., PhD, Holly Perry, M.D. Topic last updated August 18, 2015.
  • UpToDate Complications of SCUBA Diving. Dipak Chandy M.D., Gerald L Weinhouse M.D., Topic last updated November 10, 2014.
  • UpToDate Basic Principles of Wound Management. David G Armstrong DPM, M.D., PhD, Andrew J Meyr DPM. Topic last updated May 11, 2015.
  • UpToDate Necrotizing Soft Tissue Infections. Dennis L Stevens M.D. PhD, Larry M Baddour M.D., FIDSA. Topic last updated December 11, 2014.
  • Bennett MH, Stanford RE, Turner R. Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union. Cochrane Database Syst Rev 2012 Nov 14:11 CD004712. PMID 23152225
  • Buckley NA, Juurlink DN, Isbister G, et. al. Hyperbaric oxygen for carbon monoxide poisoning. Cochrane Database Syst Rev 2011 Apr 13:(4): CD002041. PMID 21491385
  • Eskes A, Vermeulen H, Lucas C. et. al. Hyperbaric oxygen therapy for treating acute surgical and traumatic wounds. Cochrane Database Syst Rev 2013 Dec 16:12: CD08059. PMID 24343585
  • Holland NJ, Bernstein JM, Hamilton JW. Hyperbaric oxygen therapy for Bell’s plasy. Cochrane Database Syst Rev. 2012 Feb 15:2: CD007288. PMID 22336830
  • Levett D, Bennett MH, Millar I. Adjunctive hyperbaric oxygen for necrotizing fasciitis. Cochrane Database Syst Rev. 2015 Jan 15:1 CD007937. PMID 25879088
  • Winfeld B. Topical oxygen and hyperbaric oxygen therapy use and healing rates in diabetic foot ulcers. Wounds 2014;26(5):E39-E47
  • Hingorani A, LaMuraglia GM, Henke P, et. la. The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society of Vascular Medicine. J Vasc Surg 2016 Feb;63(2 Suppl):3S-21S. PMID 26804367
  • UpToDate. Investigational Therapies for Treatment Symptoms of Lower Extremity Peripheral Artery Disease. Emile R. Mohler III M.D. Topic last updated July 6, 2016.
  • UpToDate. Air Embolism. Liz C. O-Dowd M.D., Mark A. Kelly M.D., MACP. Topic last updated July 26, 2016.
  • UpToDate. Management of Late Complications of Head and Neck Cancer and its Treatment. Thomas Galloway M.D., Robert J. Amdur M.D. Topic last updated September 30, 2016.
  • UpToDate. Management of Diabetic Foot Ulcers. David G. Armstrong DPM, M.D., PhD, Richard J de Asla M.D., David K. McCulloch M.D. Topic last updated January 27, 2017.
  • Kranke P, Bennett MH, Martyn-St James M, et. al. Hyperbaric Oxygen Therapy for Chronic Wounds. Cochrane Database Syst Rev 2015 Jun 24;(6):CD004123. PMID 26106870
  • Elraiyah T. Tsapas A, Prutsky G, et. al. A systematic review and meta-analysis of adjunctive therapies in diabetic foot ulcers. J Vasc Surg 2016 Feb;63(2 Suppl):46S-58S. PMID 26804368
  • Bennett MH, Feldmeier J, Hampson NB, et. al. Hyperbaric Oxygen Therapy for Late Radiation Tissue Injury. Cochrane Database Syst Rev 2016 Apr 28:4:CD005005. PMID 2713955
  • Wang F, Wang Y, Sun T, Yu HL. Hyperbaric oxygen therapy for the treatment of traumatic brain injury: a meta-analysis. Neurol Sci 2016 May;37(5):693-701. PMID 26746238
  • Crawford C, Teo L, Yang E. et. al. Is hyperbaric oxygen therapy effective for traumatic brain injury? A rapid evidence assessment of the literature and recommendations for the field. J Head Trauma Rehabil 2016 Sep 6. PMID 27603765
  • Xiong T, Chen H, Luo R, et. al. Hyperbaric oxygen therapy for people with autism spectrum disorder (ASD). Cochran Database Syst Rev. 2016 Oct 13. CD010922. PMID 27737490
  • Bennett MH, French C, Schnable A. et. al. Nomobaric and hyperbaric oxygen therapy for the treatment and prevention of migraine and cluster headache. Cochrane Database Syst Rev 2015 Dec 28;(12): CD005219. PMID 26709672
  • Huang ET, Feldmeier J, LeDex K, et. al. A clinical practice guideline for the use of hyperbaric oxygen therapy in the treatment of diabetic foot ulcers. Undersea Hyperb Med 2015 May-Jun;42(3):205-47
  • Mathieu D. Marroni A, Kot J. Tenth European Censensus  Conference on Hyperbaric Medicine: Recommendations for Accepted and Non-Accepted Clinical Indications and Practice of Hyperbaric Oxygen Treatment. Diving and Hyperbaric Medicine Volume 47 No. 1 March 2017
  • Sadri RA, Cooper JS, Hyperbaric, Complications. NCBI Bookshelf 2017.
  • de Smet GHJ, Kroese LF, Menon AG, et.al. Oxygen therapies and their effects on wound healing. Wound Repair Regen. Aug 2017;25(4):591-608. PMID 28783878
  • Borab Z, Mirmanesh MD, Gantz M, et al. Systematic review of hyperbaric oxygen therapy for the treatment of radiation-induced skin necrosis. J Plast Reconstr Aesthet Surg. Apr 2017;70(4):529-538. PMID 28081957
  • Ravi P, Vaishnavi D, Gnanam A, et al. The role of hyperbaric oxygen therapy in the prevention and management of radiation-induced complications of the head and neck - a systematic review of literature. J Stomatol Oral Maxillofac Surg. Dec 2017;118(6):359-362. PMID 28838774
  • Bennett MH, Lehm JP, Jepson N. Hyperbaric oxygen therapy for acute coronary syndrome. Cochrane Database Syst Rev. Jul 23 2015(7):CD004818. PMID 26202854
  • Sultan A, Hanna GJ, Margalit DN, et. al. The use of hyperbaric oxygen for the prevention and management of osteoradionecrosis of the jaw: a Dana-Farber/Brigham and Women’s Cancer Center Multidisciplinary Guideline. Oncologist Mar 2017;22(3):343-350. PMID 28209748
  • UpToDate. Basic Principles of Wound Management. David G. Armstrong DPM, MD, PhD, Adrew J Meyer DPM. Topic last updated December 4, 2017.
  • UpToDate. Clinical Staging and Management of Pressure Induced Skin and Tissue Injury. Dan Berlowitz MD, MPH. Topic last updated April 17, 2017.
  • Banks PG, Ho CH. A novel topical oxygen treatment for chronic and difficult to heal wounds: case studies. J Spinal Cord Med 2008;31(3):297-301. PMID 18795480
  • Bakri MH, Nagem H, Sessler DI, et. al. Transdermal oxygen does not improve sternal wound oxygenation in patients recovering from cardiac surgery. Anesth Analg 2008 June;106(6):1619-26. PMID 18499588
  • Schreml S, Szeimies RM, Prantl L, et. al. Oxygen in acute and chronic wound healing. Br J Dermatol 2010 Aug;163(2):257-68. PMID 20394633
  • Blackman E, Moore C, Hyatt J, et. al. Topical wound oxygen therapy in the treatment of severe diabetic foot ulcers: a prospective controlled trial. Ostomy Wound Manage 2010 Jun;56(6):24-31. PMID 20567051
  • Woo K, Coutts P, Sibbald G, et. al. Continuous topical oxygen for the treatment of chronic wounds: A pilot study. Advances in Skin and Wound Care December 2012 Volume 25 Issue 12 p 543-547
  • Hirsh F, Berlin SJ, Holtz A. Transdermal oxygen delivery to diabetic wounds: a report of 6 cases. Adv Skin Wound Care 2009 Jan;22(1):20-4. PMID 19096280
  • Gordillo GM, Sen CK. Evidence based recommendations for the use of topical oxygen therapy in the treatment of lower extremity wounds. Int J Low Extrem Wounds 2009 Jun:8(2):105-11. PMID 19443899
  • Sen CK. Wound healing essentials: let there be oxygen. Wound Repair Regen 2009 Jan-Feb;17(1):1-18. PMID 19152646
  • Howard MA, Asmis R, Evans KK, et. al. Oxygen and wound care: a review of current therapeutic modalities and future direction. Wound Repair Regen 2013 Jul-Aug;21(4):503-11. PMID 2376299
  • Driver VR, Yao M, Kantarci A, et. al. A prospective randomized clinical study evaluating the effect of transdermal oxygen therapy on biological processes and foot ulcer healing in persons with diabetes mellitus. Ostomy Wound Manage 2013 Nov;59(11):1-26. PMID 24201169
  • Yu J, Lu S, McLaren AM, et. al. Topical oxygen therapy results in complete wound healing in diabetic foot ulcers. Wound Repari Regen 2016 Nov2496);1066-1072. PMID 27733020
  • Brannick B, Engelthaler M, Jadzak J, et. al. A closer look at continuous diffusion of oxygen therapy for a chronic, painful venous leg ulcer. Podiatry Today Volume 27 Issue 11 November 2014
  • Couture M. Does continuous diffusion of oxygen have potential in chronic diabetic foot ulcers? Podiatry Today Vol. 28 Issue 12 December 2015
  • Niederauer M, Michalek J, Armstrong D. A prospective, randomized, double-blind multicenter study comparing continuous diffusion of oxygen therapy to sham therapy in the treatment of diabetic foot ulcers. Wound Med 2015;8:19-23
  • Sarangapani S, Mayer PV, Hoffman D. Transdermal Continuous Oxygen Therapy (TCOT) using EIPFLO. A new tool for wound healing. Journal of Wound Technology No 9 July 2010]
  • Lowell D, Nicklas B, Weily W, et. al. Transdermal continuous oxygen therapy as an adjunct for treatment of recalcitrant and painful wounds. The Foot and Ankle Journal 2(9): 4 2009
  • EPIFLO.
  • TransCu 02 Wound Care Device.

 

Policy History:

  • March 2018 - Annual Review, Policy Revised
  • March 2017 - Annual Review, Policy Revised
  • March 2016 - Annual Review, Policy Revised
  • April 2015 - Annual Review, Policy Revised
  • May 2014 - Annual Review, Policy Revised
  • July 2013 - Annual Review, Policy Revised
  • August 2012 - Annual Review, Policy Revised
  • August 2011 - Annual Review, Policy Revised

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

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