MP 2.01.04

Hyperbaric Oxygen Pressurization (HBO2)

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Medical Policy
Section Medicine	Subsection	Last Review Status/Date Reviewed with Literature search/6:2009
Issue 6:2009	Original Policy Date 12/1/95	Return to Medical Policy Index

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Disclaimer

Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.

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Description

Policy

Topical hyperbaric oxygen therapy is considered investigational.

Systemic hyperbaric oxygen pressurization may be considered medically necessary in the treatment of the following conditions:

 

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

Hyperbaric oxygen pressurization is considered  investigational in the treatment of the following conditions:

• compromised skin grafts or flaps;
• chronic refractory osteomyelitis and acute osteomyelitis, refractory to standard medical management;
• necrotizing soft-tissue infections;
• acute thermal burns;
• spinal cord injury;
• traumatic brain injury;
• severe or refractory Crohn’s disease;
• brown recluse spider bites;
• bone grafts;
• carbon tetrachloride poisoning, acute;
• cerebrovascular accident, acute (thrombotic or embolic) or chronic
• fracture healing;
• hydrogen sulfide poisoning;
• intra-abdominal and intracranial abscesses;
• lepromatous leprosy;
• meningitis;
• Pseudomembranous colitis (antimicrobial agent-induced colitis);
• radiation myelitis, cystitis enteritis, or proctitis;
• sickle cell crisis and/or hematuria;
• demyelinating diseases, e.g., multiple sclerosis, amyotrophic lateral sclerosis;
• retinal artery insufficiency, acute;
• retinopathy, adjunct to scleral buckling procedures in patients with sickle cell peripheral retinopathy and retinal detachment;
• pyoderma gangrenosum
• acute arterial peripheral insufficiency
• acute coronary syndromes and as an adjunct to coronary interventions, including but not limited to percutaneous coronary interventions and cardiopulmonary bypass;
• idiopathic sudden sensorineural hearing loss
• refractory mycoses: mucormycosis, actinomycosis, canidiobolus coronato;
• cerebral edema, acute;
• migraine;
• invitro fertilization;
• cerebral palsy.
• tumor sensitization for cancer treatments, including but not limited to, radiotherapy or chemotherapy; and
• delayed onset muscle soreness.

Policy Guidelines

Benefit Application

Rationale

Systemic Hyperbaric Oxygen

The original policy on systemic hyperbaric oxygen was based entirely on the 1996 guidelines published by the Undersea and Hyperbaric Medical Society (1) and was subsequently revised in 1999 with 3 TEC Assessments. (2-4) The 1999 TEC Assessments focused on the following applications of systemic hyperbaric oxygen:

 

In contrast to the Undersea and Hyperbaric Medical Society guidelines, the TEC Assessments concluded that there was inadequate literature to validate the effectiveness of systemic hyperbaric oxygen for the following indications:

• compromised skin grafts
• acute thermal burns
• chronic refractory osteomyelitis
• necrotizing soft tissue infections
• brown recluse spider bites

 

The TEC Assessments also considered the use of HBO for treatment of perineal Crohn’s disease, and spinal cord or brain injury, indications not addressed by the Undersea and Hyperbaric Medical Society Guidelines.

Therefore, in this policy, the 5 indications listed above for systemic hyperbaric oxygen are identified as not medically necessary, while in the prior policy they were identified as medically necessary. (It should also be noted that treatment of thermal burns, compromised skin grafts or flaps, necrotizing soft tissue infections, and chronic refractory osteomyelitis are among the labeled indications listed in the FDA 510(k) summary.)

The 1999 TEC Assessments (2-4) offered the following conclusions:

 

Compromised skin grafts

• Only 1 controlled trial studying the effects of systemic hyperbaric oxygen in the treatment of skin grafts was identified. Although this 1967 randomized study of 48 patients reported increased graft survival in the HBO-treated group, the sample included all patients undergoing skin grafting. Therefore, the success of HBO in treating the most clinically relevant subgroup of those with compromised skin grafts is unknown.
• The Assessment concluded that there was insufficient evidence to permit conclusions.

 

Acute thermal burns

• The largest controlled study of this application was a 1997 study that randomized 125 patients with acute thermal burns to systemic hyperbaric oxygen or a control group. The authors found no difference in the number of necessary surgical procedures between HBO-treated and non-treated patients, and there was no difference in hospital length of stay. (This 1997 study was not reviewed as part of the 1996 Undersea and Hyperbaric Society guidelines.)
• The Assessment concluded that the evidence did not support that HBO is beneficial in the treatment of severe acute thermal burns.

 

Chronic refractory osteomyelitis

• Justification for the use of HBO in chronic osteomyelitis has been based primarily on case series and few have instituted sufficient study controls to make that determination. There are few contemporary studies, and the introduction of more effective antibiotic therapies, advances in the method and extent of surgical debridement, more sophisticated wound coverage procedures, and improved microvascular repair in the last decade may limit the application of these earlier results to current therapy.
• The Assessment concluded that there were inadequate data to permit conclusions.

 

Necrotizing soft tissue infections

• Justification for the use of HBO in necrotizing infections has been based largely on animal studies, case reports, and retrospective reviews. Improved patient outcomes have been attributed to the adjunctive use of HBO, although these open series have failed to include a non-HBO-treated control group.
• The Assessment concluded that there were inadequate data to permit conclusions.

 

Traumatic Brain Injury

• Hyperbaric oxygen therapy has been advocated as a method of improving neurologic recovery after ischemia, however, studies in both animals and humans have yielded inconsistent results.
• The TEC Assessment focused on 2 randomized controlled studies, both of which suggested that the functional outcomes of survivors were not improved with the use of HBO.
• The Assessment concluded that there was insufficient evidence to permit conclusions.

 

Spinal Cord Injury

• The use of HBO therapy in patients with spinal cord injury is based in part on the fact that spinal cord impairment is a frequent complication of decompression sickness and that HBO is a definitive treatment of decompression sickness. The TEC Assessment focused on the use of HBO as a treatment of spinal cord injury unrelated to decompression sickness.
• The available evidence was limited to experimental animal models and small uncontrolled human series.
• The Assessment concluded that there was insufficient evidence to permit conclusions.

 

Severe or refractory Crohn’s disease

• Severe or refractory perineal wounds in Crohn’s disease resemble chronic wounds, which are frequently complicated by local tissue hypoxia and anaerobic bacteria. The presence of tissue hypoxia is the basis of HBO therapy
• The available evidence consisted of case reports, small uncontrolled case series, and 1 case-controlled report that observed intermediate outcomes only.
• The Assessment concluded that there was insufficient evidence to permit conclusions.

 

Recluse brown spider bites

• A small percentage of brown recluse spider bites produce large, slow-healing ulcerative lesions. HBO therapy has been suggested as a potential therapy, both to decrease the potency of the brown spider venom and to promote wound healing by increasing tissue oxygen tension.
• The available evidence was limited to experimental animal models and small uncontrolled human series.
• The Assessment concluded that there was insufficient evidence to permit conclusions.

 

Topical Hyperbaric Oxygen

Due to their different methods of delivery, topical and systemic hyperbaric oxygen are distinct technologies such that the outcomes associated with systemic hyperbaric oxygen therapy cannot be extrapolated to topical therapy. (5) However, there is minimal published literature regarding topical hyperbaric oxygen therapy. In 1984, Heng and colleagues published a controlled study of topical hyperbaric oxygen therapy in 6 patients with 27 ulcers compared to no treatment in 5 patients with 10 ulcers. (6) Although a greater improvement was noted in the treated group, the results were calculated according to the number of ulcers rather than based on individual patients. Leslie and colleagues reported on a trial that randomized 18 patients with diabetic foot ulcers to receive either topical hyperbaric oxygen therapy plus standard wound care or standard wound care alone. (7) Changes in ulcer size and depth did not differ between the 2 groups. Other studies consist of anecdotal reports or uncontrolled case series. (8)

Updates

Updated searches of the literature regarding topical and systemic hyperbaric oxygen therapy based on the MEDLINE database identified no articles in the published medical literature that addressed the limitations noted above for topical hyperbaric oxygen. Specifically, no controlled studies were identified. (9, 10) Therefore, the policy statement for topical HBO therapy is unchanged.

For systemic HBO, a literature search from 1995 through May 2005 was performed on MEDLINE. Several clinical trial, review, and meta-analysis publications were identified. The following summarizes the literature search findings and policy statement changes.

Chronic Wounds

A systematic review of HBO treatment for chronic wounds was conducted by Kranke and colleagues. (11,12) The authors reported finding no evidence to demonstrate benefits with use of HBO for arterial, venous, or pressure ulcers or wounds or other pathologies due to limited trial data. However, they concluded HBO did significantly reduce the risk of major amputations from diabetic ulcers based on analysis from 5 trials totaling 118 patients. Based on this information, the policy statement is revised to indicate that only diabetic wounds would be covered rather than chronic wounds. This is consistent with Medicare, which previously did not cover HBO therapy for any wound healing until April 2003 when a coverage decision was made to allow coverage for diabetic wounds of the lower extremities.

Carbon Monoxide Poisoning

Scheinkestel et al conducted a double-blind, randomized controlled trial comparing HBO to normobaric oxygen in patients with carbon monoxide poisoning. (13) The authors reported that HBO did not benefit patient outcomes of neuropsychological performance when HBO therapy was completed and at 1-month follow-up. In addition, a Cochrane review of 7 randomized controlled trials concluded the available evidence is insufficient to determine whether adverse neurologic outcomes are reduced with HBO therapy. (14). However, while evidence for the treatment of acute carbon monoxide poisoning with hyperbaric oxygen pressurization has failed to demonstrate improved health outcomes, this technology has been accepted into medical practice as a standard medical therapy for the treatment of carbon monoxide poisoning.

Radiation Necrosis

The literature review updates on radiation necrosis (osteoradionecrosis and soft tissue radiation necrosis) revealed conflicting evidence from recent clinical trials. (15-17) In a randomized, placebo-controlled, double-blind trial of 68 patients with radionecrosis of the jaw, Annane et al reported no benefit in patients receiving HBO therapy. (15) This study also noted that HBO potentially worsened outcomes, and the study was stopped before completion. Pritchard and colleagues evaluated 34 patients with radiation-induced brachial plexopathy in a double-blind randomized phase II study and reported no clear evidence of improved outcomes in patients receiving HBO therapy. (16) No other randomized clinical trials of HBO therapy for radiation necrosis were found in MEDLINE with an unlimited date search. Therefore, the policy statement is changed to indicate that radiation necrosis (osteoradionecrosis and soft tissue radiation necrosis) is investigational.

Refractory Mycoses

No clinical trials on refractory mycoses (mucormycosis, actinomycosis, canidiobolus coronato) and cerebral edema were found on an unlimited date search of MEDLINE. Therefore, these indications are changed to investigational.

Osteomyelitis

Since the 1999 TEC Assessment, there are no new prospective clinical trials on chronic refractory osteomyelitis nor are there any trials on acute osteomyelitis, refractory to standard medical management on an unlimited date search of MEDLINE. Therefore, chronic refractory osteomyelitis remains not medically necessary and acute osteomyelitis, refractory to standard medical management, is moved from medically necessary to investigational status.

Acute Peripheral Arterial Insufficiency

While Medicare has long listed acute peripheral arterial insufficiency as a medically necessary indication, this application was not addressed by previous versions of this policy. No clinical trial publications were identified that demonstrated benefit in HBO therapy for acute peripheral arterial insufficiency, and thus the evidence basis of the Medicare policy is unclear. (17) Due to the lack of published literature, acute peripheral arterial insufficiency is listed as an additional investigational indication in this policy.

Other Conditions

The literature review also identified publications that examined the role of systemic HBO as a treatment of additional indications not previously listed in the policy, including acute ischemic stroke (18); acute coronary syndromes and as an adjunct to percutaneous coronary interventions (19, 20); idiopathic sudden sensorineural hearing loss (21, 22); migraine (23); amyotrophic lateral sclerosis (24); in vitro fertilization (25); and cerebral palsy (26).

Rusyniak and colleagues reported on the results of a randomized, double-blind sham controlled study of 33 patients presenting with acute ischemic stroke who were randomized to active or sham HBO. (18) No beneficial effect was reported for HBO. Sharifi and colleagues reported on a trial that randomized 69 patients with unstable angina or acute myocardial infarction to receive or not receive HBO after a percutaneous coronary intervention (PCI). (19) The rationale behind this investigation was that HBO therapy might accelerate the healing of the microtrauma associated with a PCI and thus ultimately reduce the restenosis rate. The 24 patients randomized to the HBO group reported only 1 adverse event (death, myocardial infarction, coronary artery bypass, or revascularization of target lesion), compared to 13 in the 37 control patients. However, this study lacks adequate detail to permit scientific conclusions. For example, details of the type of PCI performed, i.e., whether a drug eluting stent was used, were not provided. In addition, a Cochrane review of 4 trials with a total of 462 patients concluded there were no significant benefits for patients with acute coronary syndromes receiving HBO. (20) Topuz and colleagues reported on a trial that randomized 51 patients with sudden idiopathic sensorineural hearing loss to receive conventional therapy (i.e., steroids, plasma expanders) with or without HBO. (21) Audiologic assessment was performed immediately after treatment. While the HBO group reported gains in hearing at some frequencies, this small trial with short follow-up is inadequate to permit scientific conclusions. A Cochrane review of 5 trials with a total of 254 patients also concluded that the data are insufficient to determine the clinical significance of hearing improvement with the use of HBO therapy in patients with idiopathic sudden sensorineural hearing loss. (22)

In a randomized, double-blind, placebo-controlled study of 40 patients, Eftedal and colleagues reported no significant reductions in migraine occurrence with HBO therapy compared to hyperbaric air treatments. (23) Steele et al treated 5 patients with amyotrophic lateral sclerosis with HBO and reported some improvements in fatigue but noted further study is needed and attention to placebo effects must be given. (24) Van Voorhis and colleagues reported HBO was well tolerated in women undergoing ovarian follicular stimulation for in vitro fertilization, however no outcomes were reported, and further study is needed. (25) Collet et al randomized 111 children with cerebral palsy to 40 treatments over a 2-month period of either HBO (n= 57) or slightly pressurized room air (n= 54). (26) The authors found HBO therapy produced similar improvements in outcomes such as gross motor function and activities of daily living in both groups as slightly pressurized air. Based on these findings, migraine, amyotrophic lateral sclerosis, in vitro fertilization, and cerebral palsy are added to the list of investigational indications.

Finally, the literature review identified a retrospective study and a review on HBO for necrotizing soft tissue infections that provide conflicting conclusions. Wilkinson and Doolette reported a reduced incidence of amputation in 44 patients with necrotizing soft tissue infections in a retrospective cohort study. (27) However, in a review of MEDLINE and PubMed literature, Jallali et al concluded that further study is needed since inconsistent results were found from the studies identified on HBO therapy for necrotizing faciitis. (28) Therefore, the policy statement on necrotizing faciitis remains investigational.

The Undersea and Hyperbaric Medical Society (UHMS) published new guidelines in 2003. (29) The UHMS’s Hyperbaric Oxygen Therapy Committee continues to consider HBO to be appropriate for these conditions:

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

 

2006 Update

A literature review update for the period of May 2005 through July 2006 identified no published clinical trials to alter the conclusions reached above. In a randomized controlled trial (RCT) of 32 patients, Heys and colleagues found no increase in 5-year survival in patients treated with HBO prior to chemotherapy for locally advanced breast carcinoma to increase tumor vascularity. (31) This approach is being studied since animal models have suggest that HBO increases tumor vascularity and thus may make chemotherapy more effective. In a Cochrane review, Bennett and colleagues concluded HBO given with radiotherapy may be useful in tumor control; however, the authors expressed caution since significant adverse effects were common with HBO and indicated further study would be useful. (32). Therefore, a policy statement is added to indicate HBO for tumor sensitization for cancer treatments, including but not limited to radiotherapy or chemotherapy, is considered investigational.

In another Cochrane review, Bennett and colleagues concluded available evidence is insufficient to demonstrate beneficial outcomes with HBO for delayed-onset muscle soreness and closed soft tissue injury. (33) It was noted that HBO possibly even increases pain initially and further studies are needed. Therefore, a policy statement is added to indicate HBO for delayed-onset muscle soreness is considered investigational. 

In an RCT of 64 patients, Alex and colleagues concluded both neuropsychometric dysfunction and inflammatory response can be reduced post-cardiopulmonary bypass when HBO pretreatment is given. (34). However, the authors noted additional studies were needed to evaluate HBO for this indication. Therefore, the investigational statement on acute coronary syndromes was modified to specify “as an adjunct to coronary interventions, including but not limited to percutaneous coronary interventions and cardiopulmonary bypass.”

In a systematic review, Carson and colleagues concluded current available evidence does not demonstrate any benefit with the use of HBO therapy for the treatment of stroke. (35) The authors noted it is undetermined whether there are any benefits with HBO therapy that would outweigh potential harms and further study is required. In a non-randomized, controlled trial of 26 patients treated with or without HBO for symptomatic cerebrovascular disease, Vila and colleagues concluded HBO therapy improved neurologic outcomes for up to 6 months. (36) However, the authors noted further study in larger patient groups is needed. 

In another systematic review, Bennett and colleagues concluded that there was “some evidence that HBO improves the probability of healing in radiation proctitis and following hemimandibulectomy and reconstruction of the mandible; improves the probability of achieving mucosal coverage and the restoration of bony continuity with ORN (osteoradionecrosis); prevents the development of ORN following tooth extraction from a radiation field; and reduces the risk of wound dehiscience following grafts and flaps in the head and neck.” (37) They also concluded that there was no benefit using HBO in important clinical outcomes with radiation brachial plexus lesions or cerebral tissue injury. No data was reported from randomized trials for other manifestations of late radiation tissue injury.

2007 - 2008 Update
Radionecrosis and Osteoradionecrosis
Results for use of HBO therapy (HBOT) for this indication continue to be published. Given the limited number of options available to patients with these late effects of radiation therapy, results of cohort studies as well as randomized trials can be used in evaluating the clinical evidence. Hampson and colleagues reported results on a series of 65 patients with radiation enteritis/proctitis and 94 patients with cystitis at one institution. (38) In this series, response was better in patients receiving 30 or more total treatments as compared with fewer treatments. In a review of management of radiation-induced necrosis, Delanian comments on the role of hyperbaric oxygen therapy as part of the “vascular” treatment of this condition. (39) In the Cochrane review of randomized trials, Bennett concludes that “these small trials suggest that for people with LRTI (Late Radiation Tissue Injury) affecting the head, neck, anus, and rectum, HBOT is associated with improved outcome. HBOT also appears to reduce the chance of osteoradionecrosis following tooth extraction in an irradiated field. There was no such evidence of any important clinical effect on neurological tissues. The application of HBOT to selected patients and tissues may be justified.” (37) The authors of this review also note that intermittent application of HBO is the only intervention that has been shown to increase the number of blood vessels in irradiated tissue; as noted, this work was first reported in the late 1980’s by Marx. In an earlier review of this topic, Feldmeier commented on a review of 74 publications representing results of applying HBO in the treatment or prevention of radiation injuries. (40) The authors appraised studies in an evidence-based fashion. All but 7 of the publications report a positive result when HBO was delivered as treatment for or prevention of delayed radiation injury. The authors also noted that these results were impressive in the context of alternative interventions such as surgery of irradiated tissue. Based on this review, the authors concluded that HBO is recommended for delayed radiation injuries for soft tissue and bony injuries of most sites. They also note an increasing body of evidence for HBO in radiation-induced necrosis of the brain, and comment that for other radiation-induced neurological injuries, additional study is required.

A 2008 Cochrane review by Esposito reviewed the use of HBO in patients requiring dental implants. (41) The authors identified one randomized trial involving 26 patients. The authors concluded that despite the limited amount of clinical research available, it appears that HBO therapy in irradiated patients requiring dental implants may not offer any appreciable clinical benefits. They indicate there is a definite need for more RCTs to ascertain the effectiveness of HBO in irradiated patients requiring dental implants.

In summary, given the long-standing use of this technology, the existing literature base, the Cochrane review noted above, and the ongoing favorable publications, the policy statement is changed to indicate that use of HBO for treatment of soft-tissue and bone radiation necrosis and for pre- and post-treatment of dental surgery (non-implant related) in an irradiated jaw may be considered medically necessary.
Carbon Monoxide (CO) Poisoning

The American College of Emergency Physicians recently published its clinical policy on critical issues in carbon monoxide poisoning. (42) This review indicated there was only Level C evidence (strategies based on preliminary, inconclusive, or conflicting evidence; or in the absence of any published literature, based on panel consensus) for treatment of acute carbon monoxide poisoning. This clinical policy indicated that:

1. HBO is a therapeutic option for CO-poisoned patients; however, its use cannot be mandated; and

2. no clinical variables, including carboxyhemoglobin levels identify a subgroup of CO-poisoned patients for whom HBO is most likely to provide benefit or cause harm.

This review cited essentially the same studies as the Cochrane review by Juurlink noted above. (14) The randomized trials reported in these have many differences and so combining results is problematic. There are 2 blinded randomized trials for HBO in CO poisoning discussed in both these reviews. The Steinkestel study is discussed above (13); one additional concern with this study was a high rate (46%) of patients who were lost to follow-up. Proponents for use of HBO in this situation frequently cite the other blinded trial by Weaver which showed improvements in a composite cognitive outcome score for those treated with hyperbaric compared to normobaric oxygen. (43) However, the authors note that the T-scores for the neuropsychological tests did not differ significantly between the treatment groups (p=0.31). They also note that T scores showed similar rates of improvement in both treatment groups between the third session and 6-week follow-up, raising questions about the impact of treatment. Thus, in light of the data from randomized trials, questions about the role of HBO in the treatment of CO poisoning persist. Given the prior use of HBO for this indication, it is considered not medically necessary.

Other Uses
Reports of uncontrolled studies, some from outside the United States, are reporting preliminary results for use of hyperbaric oxygen in other conditions such as post-operative ileus (44) and acute pancreatitis (45).

Medicare Policy

As of April 1, 2003, CMS added Medicare coverage of HBO for diabetic wounds of the lower extremities meeting certain criteria. (30) Medicare coverage is provided for HBO administered in a chamber for the following conditions:

• Acute carbon monoxide intoxication (ICD-9-CM diagnosis 986)
• Decompression illness (ICD-9-CM diagnosis 993.2, 993.3)
• Gas embolism (ICD-9-CM diagnosis 958.0, 999.1)
• Gas gangrene (ICD-9-CM diagnosis 0400)
• Acute traumatic peripheral ischemia. HBO therapy is a valuable adjunctive treatment to be used in combination with accepted standard therapeutic measures when loss of function, limb, or life is threatened (ICD-9-CM diagnosis 902.53, 903.01, 903.1, 904.0, 904.41.)
• Crush injuries and suturing of severed limbs. As in the previous conditions, HBO therapy would be an adjunctive treatment when loss of function, limb, or life is threatened (ICD-9-CM diagnosis 927.00-927.03, 927.09-927.11, 927.20-927.21, 927.8-927.9, 928.00-928.01, 928.10-928.11, 928.20-928.21, 928.3, 928.8-928.9, 929.0, 929.9, 996.90- 996.99.)
• Progressive necrotizing infections (necrotizing fasciitis) (ICD-9-CM diagnosis 728.86)
• Acute peripheral arterial insufficiency (ICD-9-CM diagnosis 444.21, 444.22, 81)
• Preparation and preservation of compromised skin grafts (not for primary management of wounds) (ICD-9CM diagnosis 996.52; excludes artificial skin graft)
• Chronic refractory osteomyelitis, unresponsive to conventional medical and surgical management (ICD-9-CM diagnosis 730.10-730.19)
• Osteoradionecrosis as an adjunct to conventional treatment (ICD-9-CM diagnosis 526.89)
• Soft tissue radionecrosis as an adjunct to conventional treatment (ICD-9-CM diagnosis 990)
• Cyanide poisoning (ICD-9-CM diagnosis 987.7, 989.0)
• Actinomycosis, only as an adjunct to conventional therapy when the disease process is refractory to antibiotics and surgical treatment (ICD-9-CM diagnosis 039.0-039.4, 039.8, 039.9)
• Diabetic wounds of the lower extremities in patients who meet the following 3 criteria:
  • Patient has type I or type II diabetes and has a lower extremity wound that is due to diabetes;
  • Patient has a wound classified as Wagner grade III or higher; and
  • Patient has failed an adequate course of standard wound therapy.

   

  The use of HBO therapy is covered as adjunctive therapy only after there are no measurable signs of healing for at least 30 days of treatment with standard wound therapy and must be used in addition to standard wound care. Standard wound care in patients with diabetic wounds includes: assessment of a patient’s vascular status and correction of any vascular problems in the affected limb, if possible, optimization of nutritional status, optimization of glucose control, debridement by any means to remove devitalized tissue, maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings, appropriate off-loading, and necessary treatment to resolve any infection that might be present. Failure to respond to standard wound care occurs when there are no measurable signs of healing for at least 30 consecutive days. Wounds must be evaluated at least every 30 days during administration of HBO therapy. Continued treatment with HBO therapy is not covered if measurable signs of healing have not been demonstrated within any 30-day period of treatment.

Medicare continues to consider topical HBO therapy ineligible for coverage.

Note: Medicare differs from BCBS policy in that it provides coverage for systemic HBO therapy for acute carbon monoxide intoxication, actinomycosis, acute peripheral arterial insufficiency, compromised skin grafts or flaps, chronic refractory osteomyelitis, necrotizing soft-tissue infections, osteoradionecrosis, and soft tissue radiation necrosis. However, as noted here, literature searches did not reveal sufficient evidence to consider these appropriate indications for HBO therapy.

 

References:

1. Camporesi EM. Hyerbaric oxygen therapy: a committee report. 1996. Undersea and Hyperbaric Medical Society. Kensington, MD.
2. 1999 TEC Assessment; Tab 13
3. 1999 TEC Assessment; Tab 15
4. 1999 TEC Assessment; Tab 16
5. Heng MC. Topical hyperbaric therapy for problem skin wounds. J Dermatol Surg Oncol 1993; 19(8):784-93.
6. Heng MC, Pilgrim JP, Beck FW. A simplified hyperbaric oxygen technique for leg ulcers. Arch Dermatol 1984; 120(5):640-5.
7. Leslie CA, Sapico FL, Ginunas VJ et al. Randomized controlled trial of topical hyperbaric oxygen for treatment of diabetic foot ulcers. Diabetes Care 1988; 11(2):111-5.
8. Landau Z. Topical hyperbaric oxygen and low energy laser for the treatment of diabetic foot ulcers. Arch Orthop Trauma Surg 1998; 117(3):156-8.
9. Landau Z, Schattner A. Topical hyperbaric oxygen and low energy laser therapy for chronic diabetic foot ulcers resistant to conventional treatment. Yale J Biol Med 2001; 74(2):95-100.
10. Edsberg LE, Brogan MS, Jaynes CD et al.Topical hyperbaric oxygen and electrical stimulation: exploring potential synergy. Ostomy Wound Manage 2002; 48(11):42-50.
11. Kranke P, Bennett M, Roeckl-Wiedmann I et al.Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev 2004; (2):CD004123.
12. Roeckl-Wiedmann I, Bennett M, Kranke P. Systematic review of hyperbaric oxygen in the management of chronic wounds. Br J Surg 2005; 92(1):24-32.
13. Scheinkestel CD, Bailey M, Myles PS, et al.Hyperbaric or normobaric oxygen for acute carbon monoxide poisoning: a randomized controlled clinical trial. Med J Aust 1999; 170(5):203-10.
14. Juurlink DN, Buckley NA, Stanbrook MB et al. Hyperbaric oxygen for carbon monoxide poisoning. Cochrane Database Syst Rev 2005; (1): CD002041.
15. Annane D, Depondt J, Aubert P et al. Hyperbaric oxygen therapy for radionecrosis of the jaw: a randomized, placebo-controlled, double-blind trial from the ORN96 study group. J Clin Oncol 2004; 22(24):4893-900.
16. Pritchard J, Anand P, Broome J et al. Double-blind randomized phase II study of hyperbaric oxygen in patients with radiation-induced brachial plexopathy. Radiother Oncol 2001; 58(3):279-86.
17. Verrazzo G, Coppola L, Luongo C et al. Hyperbaric oxygen, oxygen-ozone therapy, and rheologic parameters of blood in patients with peripheral occlusive arterial disease. Undersea Hyperb Med 1995; 22(1):17-22.
18. Rusyniak DE, Kirk MA, May JD et al.Hyperbaric oxygen therapy in acute ischemic stroke: results of the Hyperbaric Oxygen in Acute Ischemic Stroke Trial Pilot Study. Stroke 2003; 34(2):571-4.
19. Sharifi M, Fares W, Abdel-Karim I et al.Usefulness of hyperbaric oxygen therapy to inhibit restenosis after percutaneous coronary intervention for acute myocardial infarction or unstable angina pectoris. Am J Cardiol 2004; 93(12):1533-5.
20. Bennett M, Jepson N, Lehm JP. Hyperbaric oxygen therapy for acute coronary syndrome. Cochrane Database Syst Rev 2005; (2): CD004818.
21. Topuz E, Yigit O, Cinar U et al.Should hyperbaric oxygen be added to treatment in idiopathic sudden sensorineural hearing loss? Eur Arch Otorhinolaryngol 2004; 261(7):393-6.
22. Bennett MH, Kertesz T, Yeung P. Hyperbaric oxygen for idiopathic sudden sensorineural hearing loss and tinnitus. Cochrane Database Syst Rev 2005; (1): CD004739.
23. Eftedal OS, Lydersen S, Helde G et al. A randomized, double blind study of the prophylactic effect of hyperbaric oxygen therapy on migraine. Cephalalgia 2004; 24(8):639-44.
24. Steele J, Matos LA, Lopez EA et al.A Phase I safety study of hyperbaric oxygen therapy for amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord 2004; 5(4):250-4.
25. Van Voorhis BJ, Greensmith JE, Dokras A et al.Hyperbaric oxygen and ovarian follicular stimulation for in vitro fertilization: a pilot study. Fertil Steril 2005; 83(1):226-8.
26. Collet JP, Vanasse M, Marois P et al.Hyperbaric oxygen for children with cerebral palsy: a randomised multicentre trial. HBO-CP Research Group. Lancet 2001; 357(9256):582-6.
27. Wilkinson D, Doolette D. Hyperbaric oxygen treatment and survival from necrotizing soft tissue infection. Arch Surg 2004; 139(12):1339-45.
28. Jallali N, Withey S, Butler PE. Hyperbaric oxygen as adjuvant therapy in the management of necrotizing fasciitis. Am J Surg 2005; 189(4):462-6.
29. Undersea and Hyperbaric Medical Society. Hyperbaric Oxygen Therapy Committee Report 2003. http://www.uhms.org/Indications/indications.htm.
30. Medicare Coverage Issues Manual. http://www.cms.hhs.gov/manuals/pm_trans/R164CIM.pdf.
31. Heys SD, Smith IC, Ross JA et al.A pilot study with long term follow up of hyperbaric oxygen pretreatment in patients with locally advanced breast cancer undergoing neo-adjuvant chemotherapy. Undersea Hyperb Med 2006; 33(1):33-43.
32. Bennett M, Feldmeier J, Smee R et al. Hyperbaric oxygenation for tumour sensitisation to radiotherapy. Cochrane Database Syst Rev 2005; (4):CD005007.
33. 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.
34. Alex J, Laden G, Cale AR et al. Pretreatment with hyperbaric oxygen and its effect on neuropsychometric dysfunction and systemic inflammatory response after cardiopulmonary bypass: a prospective randomized double-blind trial. J Thorac Cardiovasc Surg 2005; 130(6):1623-30.
35. Carson S, McDonagh M, Russman B et al. Hyperbaric oxygen therapy for stroke: a systematic review of the evidence. Clin Rehabil 2005; 19(8):819-33.
36. VilaJF, Balcarce PE, Abiusi GR et al. Improvement in motor and cognitive impairment after hyperbaric oxygen therapy in a selected group of patients with cerebrovascular disease: a prospective single-blind controlled trial. Undersea Hyperb Med 2005; 32(5):341-9.
37. Bennett MH, Feldmeier J, Hampson N et al. Hyperbaric oxygen therapy for late radiation tissue injury. Cochrane Database Syst Rev 2005; (3):CD005005.
38. Hampson NB, Corman JM. Rate of delivery of hyperbaric oxygen treatments does not affect response in soft tissue radionecrosis. Undersea Hyperb Med 2007; 34(5):329-34.
39. Delanian S, Lefaix JL. Current management for late normal tissue injury: radiation-induced fibrosis and necrosis. Semin Radiat Oncol 2007; 17(2):99-107
40. Feldmeier JJ, Hampson NB. A systematic review of the literature reporting the application of hyperbaric oxygen prevention and treatment of delayed radiation injuries: an evidence based approach. Undersea Hyperb Med 2002; 29(1):4-30.
41. Esposito M, Grusovin M, 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
42. American College of Emergency Physicians Clinical Policies Subcommittee (Writing Committee) on Critical Issues in the Management of Adult Patients Presenting to the Emergency Department with Carbon Monoxide Poisoning; Wolf SJ, Lavonas EJ, Sloan EP et al. Clinical policy: Critical issues in the management of adult patients presenting to the emergency department with acute carbon monoxide poisoning. Ann Emerg Med 2008; 51(2):138-52.
43. Weaver LK, Hopkins RO, Chan KJ et al. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl J Med 2002; 347(14):1057-67.
44. Ambiru S, Furuyama N, Aono M et al. Hyperbaric oxygen therapy for the treatment of postoperative paralytic ileus and adhesive intestinal obstruction associated with abdominal surgery: experience with 626 patients. Hepatogastroenterology 2007; 54(79):1925-9.
45. Christophi C, Millar I, Nikfarjam M et al. Hyperbaric oxygen therapy for severe acute pancreatitis. J Gastroenterol Hepatol 2007; 22(11):2042-6.

Index

Policy History