Hyperbaric Oxygen Therapy

Transcription

1 MEDICAL POLICY POLICY RELATED POLICIES POLICY GUIDELINES DESCRIPTION SCOPE BENEFIT APPLICATION RATIONALE REFERENCES CODING APPENDIX HISTORY Hyperbaric Oxygen Therapy Number * Effective Date October 13, 2015 Revision Date(s) 10/13/15; 10/13/14; 10/14/13; 10/09/12; 07/12/11; 06/08/10; 08/11/09; 02/12/08; 03/13/07; 03/14/06; 03/08/05; 03/09/04; 07/08/03; 12/10/02; 09/11/01; 01/04/99; 03/03/98; 05/05/97 Replaces Policy Systemic hyperbaric oxygen pressurization may be considered medically necessary in the treatment of the following conditions: Air or gas embolism, acute; Carbon monoxide poisoning, acute (see Policy Guidelines); Gas gangrene (Clostridial myositis and myonecrosis); Crush injury with acute traumatic ischemia; Decompression sickness; Arterial insufficiency: including chronic nonhealing wounds and central retinal artery occlusion; Severe anemia: only when blood transfusion is impossible or must be delayed; Refractory intracranial abscess; Necrotizing soft tissue infections; Osteomyelitis refractory to standard medical and surgical management; Radiation necrosis (osteoradionecrosis and soft tissue radiation necrosis), radiation injury, and in select cases, prophylactic treatment prior to surgery in patients with previously irradiated fields; Thermal burns, acute: medically necessary only for the treatment of second and third degree burns involving 90% and 15% of total body surface, respectively, and initiated within 24 hours of the burn; Compromised skin grafts or flaps; and Diabetic lower extremity wounds, Wagner Grade 3 or 4. For any other conditions, systemic hyperbaric oxygen is considered not medically necessary. Topical hyperbaric oxygen therapy is considered investigational. Related Policies None

2 Policy Guidelines Systemic Hyperbaric Oxygen The Undersea and Hyperbaric Medical Society (UHMS) 2008 Hyperbaric Oxygen Therapy Committee Report suggests utilization of HBO 2 as described below: Carbon monoxide poisoning up to five treatments with suggested indications of: o Transient or persistent loss of consciousness; o Abnormal neuropsychological screening; o Carboxyhemoglobin level > 25%; o Pregnancy and carboxyhemoglobin level > 15% or evidence of fetal distress; o Signs of cardiac ischemia or arrhythmia; or o Symptoms that do not resolve with normobaric oxygen after four-to-six hours. Gas gangrene up to 10 treatments. Crush injury up to eight treatments. Decompression sickness: Treatment times vary, depending upon length of time elapsed between symptoms and initiation of treatment and between residual symptoms after initial treatment. Repetitive treatments up to a total of 10 treatments may be necessary, depending upon the patient s response. Central retinal artery occlusion: The optimum number of treatments will vary depending on the severity and duration of the patient s symptoms and the degree of response to treatment. The majority of patients will stabilize within one week of symptom onset. Utilization review is recommended for patients treated for more than three days after clinical plateau and no further improvement. Severe anemia up to 10 treatments. HBO 2 is indicated when the patient will not accept blood replacement for medical or religious reasons and the following symptoms are present: a) shock, systolic blood pressure below 90 mmhg, or pressure maintained by vasopressors; b) disorientation to coma; c) ischemic changes of the myocardium as demonstrated on the EKG; and d) ischemic gut. HBO 2 therapy is continued repetitively as needed and discontinued when the red blood cells have been replaced in numbers to alleviate the preceding signs and symptoms. Necrotizing soft tissue infections: Treatment in the initial phase is typically delivered twice daily until the patient s clinical condition stabilizes, then once daily until the infection is controlled. It may be necessary in some instances to extend the treatment up to a total of 30 hyperbaric treatments. Refractory osteomyelitis: These are patients with osteomyelitis that have standard treatment with surgical debridement and appropriate antibiotic therapy. Utilization review is recommended after 40 HBO 2 treatments. Radiation necrosis or chronic radiation injury: Utilization review is required after 60 treatments. Treatments are usually given once or twice daily. Compromised skin grafts and flaps: Utilization review is required after 20 treatments when preparing a recipient site for a flap or graft, and following 20 treatments after the graft or flap has been placed into the recipient site. Thermal burns: Treatment is begun as soon as possible and given three times in the first 24 hours and twice daily thereafter for 90 minutes per treatment. In cases where burns cover 40% or more of the body, treatment is rendered for 10 to 14 days. Transporting patients over long distances is not recommended, and patients should not be transported to a hyperbaric chamber that is not within the burn center. Utilization review is recommended after 30 treatments. Diabetic wounds: Utilization review for diabetic wounds is recommended after 30 treatments. The Centers for Medicare & Medicaid Services (CMS) recommends the use of HBO 2 in the treatment of diabetic wounds of the lower extremities when all of the following criteria are met: The patient has type I or type II diabetes and has a lower extremity wound that is due to diabetes; The patient has a wound classified as Wagner grade III or higher; and The patient has failed an adequate course of standard wound therapy. CMS also offers the following utilization guideline for treatment of diabetic wounds :

3 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. Description Hyperbaric oxygen therapy (HBO 2 ) is a technique of delivering higher pressures of oxygen to the tissues. Two methods of administration are available. In systemic or large chamber hyperbaric oxygen treatment, the patient is entirely enclosed in a pressure chamber and breathes oxygen at a pressure greater than one atmosphere (the pressure at sea level). This technique relies on the systemic circulation to deliver highly oxygenated blood to the target site, commonly a wound. In addition, systemic hyperbaric oxygen therapy can be used to treat systemic illness such as air or gas embolism, carbon monoxide poisoning, clostridial gas gangrene, etc. Treatment may be carried out either in a monoplace chamber pressurized with pure oxygen or in a larger, multiplace chamber pressurized with compressed air, in which case the patient receives pure oxygen by mask, head tent, or endotracheal tube. Topical hyperbaric oxygen therapy describes a technique of delivering 100% oxygen directly to an open, moist wound at a pressure slightly higher than atmospheric pressure. It is hypothesized that the high concentrations of oxygen diffuse directly into the wound to increase the local cellular oxygen tension, which in turn promotes wound healing. Topical hyperbaric oxygen devices consist of an appliance to enclose the wound area (frequently an extremity) and a source of oxygen; conventional oxygen tanks may be used. The appliances may be disposable and may be used without supervision in the home by well-trained patients. Topical hyperbaric oxygen therapy has been investigated as a treatment of skin ulcerations due to diabetes, venous stasis, postsurgical infection, gangrenous lesion, decubitus ulcers, amputations, skin graft, burns, or frostbite. Scope Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations.* Benefit Application N/A Rationale 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. (1) 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 six patients with 27 ulcers compared to no treatment in five patients with 10 ulcers. (2) 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

4 either topical hyperbaric oxygen therapy plus standard wound care or standard wound care alone. (3) Changes in ulcer size and depth did not differ between the two groups. Other studies consist of anecdotal reports or uncontrolled case series. The Undersea and Hyperbaric Medical Society position statement in regards to topical oxygen is stated as follows: 1. Topical oxygen should not be termed hyperbaric oxygen since doing so either intentionally or unintentionally suggests that topical oxygen treatment is equivalent or even identical to hyperbaric oxygen. Published documents reporting experience with topical oxygen should clearly state that topical oxygen not hyperbaric oxygen is being employed. 2. Mechanisms of action or clinical study results for hyperbaric oxygen cannot and should not be co-opted to support topical oxygen since hyperbaric oxygen therapy and topical oxygen have different routes and probably efficiencies of entry into the wound and their physiology and biochemistry are necessarily different. 3. The application of topical oxygen cannot be recommended outside of a clinical trial at this time based on the volume and quality of scientific supporting evidence available, nor does the Society recommend thirdparty payor reimbursement. Before topical oxygen can be recommended as therapy for non-healing wounds, its application should be subjected to the same intense scientific scrutiny to which systemic hyperbaric oxygen has been held Update A search of the literature regarding topical hyperbaric oxygen therapy based on the MEDLINE database was performed for the period of 1999 through November No articles in the published medical literature were identified that addressed the limitations noted above for topical hyperbaric oxygen. Specifically, no controlled studies were identified. Therefore, the policy statement concerning topical hyperbaric oxygen is unchanged. UHMS updated their 2004 guidelines in UHMS s Hyperbaric Oxygen Therapy Committee considered HBO to be appropriate for these conditions: 1. Air or gas embolism, acute; 2. Carbon monoxide poisoning and carbon monoxide complicated by cyanide poisoning; 3. Clostridal myositis and myonecrosis (gas gangrene); 4. Crush injury, compartment syndrome and other acute traumatic ischemias; 5. Decompression sickness; 6. Arterial insufficiencies, 7. Enhancement of healing in selected problem wounds, and 8. Central retinal artery occlusion; 9. Exceptional blood loss (anemia); 10. Intracranial abscess; 11. Necrotizing soft tissue infections; 12. Osteomyelitis (refractory); 13. Delayed radiation injury (soft tissue and bony necrosis); 14. Skin grafts and flaps (compromised); and 15. Thermal burns Update A January 2006 update of PubMed did not identify any new large randomized clinical trials that would lead to a change in the policy statement. Medicare Policy As of April 1, 2003, CMS added Medicare coverage of HBO 2 for diabetic wounds of the lower extremities meeting certain criteria. Medicare coverage is provided for HBO administered in a chamber for: 1. Acute carbon monoxide intoxication (ICD-9-CM diagnosis 986).

5 2. Decompression illness (ICD-9-CM diagnosis 993.2, 993.3). 3. Gas embolism (ICD-9-CM diagnosis 958.0, 999.1). 4. Gas gangrene (ICD-9-CM diagnosis 040.0). 5. 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 , , 904.0, ). 6. 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 , , , , , , , 928.3, , 929.0, 929.9, ). 7. Progressive necrotizing infections (necrotizing fasciitis) (ICD-9-CM diagnosis ). 8. Acute peripheral arterial insufficiency (ICD-9-CM diagnosis , , 81) 9. Preparation and preservation of compromised skin grafts (not for primary management of wounds) (ICD- 9-CM diagnosis ; excludes artificial skin graft). 10. Chronic refractory osteomyelitis, unresponsive to conventional medical and surgical management (ICD-9- CM diagnosis ). 11. Osteoradionecrosis as an adjunct to conventional treatment (ICD-9-CM diagnosis ). 12. Soft tissue radionecrosis as an adjunct to conventional treatment (ICD-9-CM diagnosis 990). 13. Cyanide poisoning (ICD-9-CM diagnosis 987.7, 989.0). 14. Actinomycosis, only as an adjunct to conventional therapy when the disease process is refractory to antibiotics and surgical treatment (ICD-9-CM diagnosis , 039.8, 039.9). 15. Diabetic wounds of the lower extremities in patients who meet the following three criteria: 16. The patient has type I or type II diabetes and has a lower extremity wound that is due to diabetes; 17. The patient has a wound classified as Wagner grade III or higher; and 18. The patient has failed an adequate course of standard wound therapy. The use of HBO 2 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-leading, 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 2 therapy. Continued treatment with HBO 2 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 2 therapy ineligible for coverage Update 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. 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 60 months. However, the authors noted further study in larger patient groups is needed. In another systemic 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; improve the probability of achieving mucosal coverage and the restoration of bony continuity with ORN (osteoradionecrosis); prevents the development of ORN following tooth extraction from a radiation field; and reduces the risk of wound dehiscence following grafts and flaps in the head and neck. 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. Given the small size of many of these trials, the extended time periods for reporting, and the poor metholodological quality of some studies, no changes were made in the policy statements on the basis of this review.

6 2008 Update Acute cyanide poisoning has been removed from the policy as an indication for HBO. There is now an antidote that is commercially available. The FDA approved the Cyanokit (containing the drug hydroxocobalamin) for the treatment of known or suspected cyanide poisoning in December The Cyanokit became available in the US in March Update Clarke and associates, 2008, performed a randomized, controlled, double-blind crossover trial for hyperbaric oxygen treatment of chronic refractory radiation proctitis. Their results showed hyperbaric oxygen therapy significantly improved the healing responses in patients with refractory radiation proctitis, generating an absolute risk reduction of 32% (number to treat of 3) between the groups after the initial allocation. Other medical management requirements were discontinued, and advanced interventions were largely avoided. Enhanced bowel-specific quality of life resulted. 120 patients were evaluated over five years Update The UHMS guidelines were last updated in 2008 and CMS has not changed its covered conditions. A review of the literature from September 2009 through April 2010 did not reveal any studies which would prompt a change in the policy statement Update A review of the literature from May 2010 through May 2011 did not find any studies which would prompt a change in the policy statements Update Bennet and colleagues published a Cochrane review on hyperbaric oxygen therapy for late radiation tissue injury. (25) [This is an update to their 2005 review (21).] The authors identified 11 RCTs; there was variability among trials and study findings were not pooled for the primary outcomes of survival, complete resolution of necrosis or tissue damage, and improvement in a late effects symptom scale. In a pooled analysis of 3 studies, a significantly higher proportion of patients with osteoradionecrosis achieved complete mucosal cover after hyperbaric oxygen treatment compared to control 9risk ratio [RR]: 1.30, 95% CI: 1.09 to 1.55) From their review of the literature, the authors concluded that data from small trials suggest that for people with LRTI (Late Radiation Tissue Injury) affect8n the head, neck anus, and rectum, [HBO] is associated with improved outcome. HBO also appears to reduce the chance of ORN (osteoradionecrosis) following tooth extraction in an irradiated field. There was no such evidence of any important clinical effect on neurological tissues. The application of HBOT to selected patients and tissues may be justified. In 2012, Shao and colleagues in China published an RCT including 36 patients who had undergone radiotherapy for pelvic malignancies and had radiation-induced hemorrhagic cystitis. (20) Patients were randomized to treatment with hyaluronic acid (n=16) or hyperbaric oxygen (n=20). The hyaluronic acid group received weekly injections for the first month and monthly injections for the following 2 months. HBO treatment consisted of 30- minute sessions daily for one month. All patients completed the study. There were no statistically significant differences in outcomes e.g., pain or voids per day 6, 12, or 18 months after treatment. For example, at 12 months after treatment, the number of voids per day was 8.9 in the hyaluronic acid group and 9.7 in the HBO group, p>0.05. The study may have been underpowered to detect statistically significant differences between groups. An updated Cochrane review of RCTs on HBO treatment for chronic wounds was published by Kranke and colleagues in (8) The authors identified 9 RCTs with a total of 471 participants that compared the effect of HBO on chronic wound healing compared to an alternative treatment approach that did not use HBO. Eight of the 9 trials included in the review evaluated HBO therapy in patients with diabetes. The remaining trial addressed HBO for patients with venous ulcers; that study had only 16 participants and the comparator treatment was not specified. In a pooled analysis of data from 3 trials, a significantly higher proportion of ulcers had healed at the end of the treatment period (6 weeks) in the group receiving HBO compared to the group not receiving HBO (RR: 5.20: 95% CI: 1.25 to 21.7). Pooled analyses, however, did not find significant differences between groups in the

7 proportion of ulcers healed in the HBO versus non-hbo-treated groups at 6 months (2 trials) or 12 months (3 trials). There were insufficient data to conduct pooled analyses of studies evaluating HBO for treating patients with chronic wounds who did not have diabetes Update A review of the literature from October 2012 through September 2013 did not find any new studies which would prompt a change in the policy statements Update A review of the literature from October 2013 through August 2014 did not find any new studies which would prompt a change in the policy statements Update In 2011, UHMS added idiopathic sudden sensorineural hearing loss (ISSNHL) within the past 14 days of symptom onset as an approved indication for HBOT. In 2012, the American Academy of Otolaryngology-Head and Neck Surgery published a clinical guideline on treatment of sudden hearing loss. (74) 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]. However, due to methodologic limitations and variability among published studies, as well as inconsistent findings, the evidence is insufficient to draw conclusions about the effect of HBOT on health outcomes in patients with ISSNHL. A 2012 Cochrane review on HBOT for ISSNHL and tinnitus identified 7 RCTs with a total of 392 participants. (47) All trials included patients with ISSNHL with and/or without tinnitus; 2 trials also included patients with tinnitus in the absence of ISSNHL. Randomization procedures were only described in 1 study, and only 1 study stated they blinded participants to treatment group assignment using sham therapy. Six of the studies included time-based entry criteria for hearing loss and/or tinnitus; this was 48 hours in 3 studies, 2 weeks in 2 studies (for acute presentation), and 6 months in 1 study. The dose of oxygen per treatment session and the treatment protocols varied among studies (e.g., the total number of treatment sessions varied from 10-25). All trials reported on change in hearing following treatment; but specific outcomes varied. Two trials reported the proportion of participants with greater than 50% return of hearing at the end of therapy. A pooled analysis of these studies did not find a statistically significant difference in outcomes between the HBOT and the control groups (RR=1.53; 95% CI: 0.86 to 2.78). In contrast, a pooled analysis of 2 trials reporting the proportion of participants with greater than 25% return of hearing at the end of therapy found a significantly higher rate of improvement after HBOT than a control intervention (RR=1.39; 95% CI: 1.05 to 1.84). Moreover, a pooled analysis of 4 trials found a significantly greater mean improvement in hearing over all frequencies with HBOT compared with control (mean difference, 15.6 db; 95% CI: 1.5 to 29.8). The authors stated that, due to methodologic shortcomings of the trials and the modest number of patients, results of the meta-analysis should be interpreted cautiously; they did not recommend use of HBOT for treating ISSNHL. In 2013, Cvorovic et al. published an RCT that included 50 patients with ISSNHL who had failed primary therapy with intravenous steroids.(48) Patients were randomized to receive HBOT (20 sessions, 5 daily sessions per week) or intratympanic steroid injection (4 injections in 13 days). The HBOT sessions consisted of 10 minutes of compression on air, 60 minutes of 100% oxygen at 2 ata, and 10 minutes of decompression on air. Outcomes were change in the mean hearing thresholds at each of 5 frequencies (0.25, 0.5, 1, 2, and 4 khz). After treatment, there were no statistically significant differences in mean hearing thresholds at 4 of the 5 frequencies. The exception was 2 khz, and at that frequency, the improvement was significantly greater in the HBOT group.

8 References 1. Weaver LK, Hopkins RO, Chan KJ et al. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl J Med 2002; 347(14): Heng MC. Topical hyperbaric therapy for problem skin wounds. J Dermatol Surg Oncol 1993; 19(18): Landau Z. Topical hyperbaric oxygen and low energy laser for the treatment of diabetic foot ulcers resistant to conventional treatment. Yale J Biol Med 2001; 74(2): Heng, MC et al. Enhanced healing and cost-effectiveness of low pressure oxygen therapy I healing necrotic wounds: a feasibility study of technology transfer. Ostomy/Wound Management 2000; 46(3):52-60, Kalani, M. Hyperbaric oxygen (HBO) therapy in treatment of diabetic foot ulcers. Long-term follow-up. J Diabetes 2002; 16(2): Abidia A, Kuhan G, Laden G et al. Hyperbaric oxygen therapy for diabetic leg ulcers a double blind randomized controlled trial. Undersea Hyperbaric Medicine 2001; 28(Suppl): Zamboni W, Wong H, Stephenson L et al. Evaluation of hyperbaric oxygen for diabetic wounds: a prospective study. Undersea Hyperbaric Medicine 1997; 24(3): Doctor N, Pandya S, Supe A. Hyperbaric oxygen therapy in diabetic foot. Journal of Postgraduate Medicine 1992; 38(3): Faglia E, Favales F, Aldeghi A et al. Adjunctive systemic hyperbaric oxygen therapy in treatment of severe prevalently ischemic diabetic foot ulcer: a randomized study. Diabetes Care 1996; 19(12): Oriani G, Michael M, Meazza D et al. Diabetic foot and hyperbaric oxygen therapy: a ten-year experience. Journal of Hyperbaric Medicine 1992; 7(4): Stone J, Scott R, Brill L et al. The role of hyperbaric oxygen in the treatment of diabetic foot wounds. Diabetes Care 1995; 44(Suppl):71A. 12. Rusyniak DE, Kirk MA, May JD et al. Hyperbaric oxygen therapy in acute ischemic stroke. Stroke 2003; 34: 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: 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: Undersea and Hyperbaric Medical Society. Hyperbaric Oxygen Therapy Committee Report. Indications for Hyperbaric Oxygen Therapy. Last accessed September 25, Centers for Medicare & Medicaid Services (CMS). National Coverage Decision (NCD) for Hyperbaric Oxygen Therapy (20.29). Effective June 19, Last accessed September 3, Agency for Healthcare Research and Quality (AHRQ). Hyperbaric Oxygen Therapy for Brain Injury, Cerebral Palsy, and Stroke. Summary, Evidence Report/Technology Assessment: Number 85. AHRQ Publication Number 03-E049, September Last accessed September 3, Feldmeier JJ, Hopf HW, Warriner RA 3rd et al. UHMS position statement: topical oxygen for chronic wounds. Undersea Hyperb Med May-June; 32(3): Carson S, McDonagh M, Russman B et al. Hyperbaric oxygen therapy for stroke: a systematic review of the evidence. Clin Rehabil 2005;19(8): Vila JF, 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): Bennett MH, Feldmeier J, Hampson N et al. Hyperbaric oxygen therapy for late radiation tissue injury. Cochrane Database Syst Rev 2005;(3):CD Weaver LK, Valentine KJ, Hopkins RO. Carbon monoxide poisoning: Risk factors for cognitive sequelae and the role of hyperbaric oxygen. Am J Resp Crit Care Med 2007; 176(5): Clarke RE, Catalina Tenorio LM, Hussey JR et al. Hyperbaric Oxygen Treatment of Chronic Refractory Radiation Proctitis: A Randomized and Controlled Double-Blind Crossover Trial With Long-Term Follow- Up. Int J Rad Onc Biol Phys 2008; Sept 1;72(1): Policy was reviewed by a board certified physician in the specialty of Undersea and Hyperbaric Medicine: 2009; 2010.

9 25. Bennett MH, Feldmeier J, Hampson N et al. Hyperbaric oxygen therapy for late radiation tissue injury. Cochrane Database Syst Rev 2012; 5:CD Shao Y, Lu GL, Shen ZJ. Comparison of intravesical hyaluronic acid instillation and hyperbaric oxygen in the treatment of radiation-induced hemorrhagic cystitis. BJU Int 2012; 109(5): Kranke P, Bennett MH, Martyn-St James M et al. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev 2012; 4:CD American Academy of Otolaryngology-Head and Neck Surgery. Clinical practice guideline: sudden hearing loss. 2012; Last accessed September 25, Bennett MH, Kertesz T, Perleth M, et al. Hyperbaric oxygen for idiopathic sudden sensorineural hearing loss and tinnitus. Cochrane Database Syst Rev. 2012;10:CD 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): Coding Codes Number Description CPT Physician attendance and supervision of hyperbaric oxygen therapy, per session HCPCS G0277 Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval Type of Medical Service Place of Service Inpatient/Out patient Appendix N/A History Date Reason 05/05/97 Add to Medicine Section - New Policy. 03/03/98 Replace Policy - Reviewed with changes; new indications. 01/04/99 Replace Policy - Policy reviewed; now includes topical hyperbaric oxygen. 09/11/01 Replace Policy - Scheduled update. 12/10/02 Replace Policy - Policy updated; only topical hyperbaric oxygen reviewed; policy statement unchanged. 07/08/03 Replace Policy - Scheduled review, policy statement unchanged. 03/09/04 Replace Policy - Policy reviewed and updated. Medicare policy and Undersea and Hyperbaric Medical Society guidelines added. 09/01/04 Replace Policy - Policy renumbered from PR No date changes. 03/08/05 Replace Policy - Scheduled review. Policy statement deleted cerebral edema and refractory mycosis as no longer medically necessary. Policy Guidelines and References updated. 03/14/06 Replace Policy - Scheduled review. Codes updated; no change to policy statement. 06/26/06 Update Scope and Disclaimer - No other changes 03/13/07 Replace Policy - Policy updated with literature review; reference updated. No change in policy statement.

10 02/12/08 Replace Policy - Policy updated with literature search. Policy statement updated to delete Cyanide Poisoning as a medically necessary indication. Policy Guidelines and References updated. 08/11/09 Replace Policy - Policy updated with literature search. Policy statement updated to add medically necessary indication arterial insufficiency: including chronic nonhealing wounds and central retinal artery occlusion. Reference added. 09/15/09 Minor Updates - Outpatient added to Place of Service. 06/08/10 Replace Policy - Policy updated with literature search. No change to the policy statement. Guidelines contain new recommendation of UR for diabetic wounds after 30 treatments. Reference added. Policy title changed from Hyperbaric Oxygen Pressurization to Hyperbaric Oxygen Therapy. On hold for 90 days, release to publish in November /01/10 Publish Policy - Subsequent to 90-day hold for notification. 07/12/11 Replace Policy - Policy updated with literature review; no change in policy statement. 10/26/12 Replace policy. Added references 25, 26, 27. Policy statement unchanged. 10/14/13 Replace policy. Policy updated with literature review; no change in policy statement. 12/03/13 Coding Update. Add ICD-10 codes. 03/11/14 Coding Update. Code was removed per ICD-10 mapping project; this code is not utilized for adjudication of policy. 11/20/14 Annual Review. No change to policy statements. ICD-9 and ICD-10 diagnosis codes removed; these are not utilized in policy adjudication. 01/05/15 Coding update. New HCPCS code G0277, effective 1/1/15, added to the policy. 10/13/15 Annual Review. Policy updated with literature review; no change to policy statement. Information regarding sudden sensorineural hearing loss added to Rationale. References added. Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA) Premera All Rights Reserved.