DESCRIPTION
Hyperbaric oxygen pressurization therapy (HBO2) is a technique of delivering high pressures of oxygen to tissue. Two methods of administration are available, systemic or topical:
Systemic or large chamber hyperbaric oxygen, the individual is entirely enclosed in a pressure chamber and breathes oxygen at a pressure greater than one atmosphere (the pressure of O2 at sea level). This technique relies on systemic circulation to deliver highly oxygenated blood to the target site, typically a wound. In addition, systemic hyperbaric oxygen therapy can be used to treat illnesses 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. The individual receives pure oxygen by mask, head tent, or endotracheal tube.
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. 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 (e.g., conventional oxygen tanks). The appliances may be disposable and may be used without supervision in the home by well-trained individuals. Topical hyperbaric oxygen therapy has been investigated as a treatment of skin ulcerations due to diabetes, venous stasis, postsurgical infection, gangrenous lesions, decubitus ulcers, amputations, skin grafts, burns, and frostbite.
POLICY
Systemic hyperbaric oxygen pressurization therapy as a primary treatment is considered medically necessary for the following conditions:
Acute carbon monoxide poisoning
Acute traumatic ischemia
Cyanide poisoning, acute
Decompression sickness
Gas embolism, acute
Gas gangrene
Pre- and post-treatment for individuals undergoing dental surgery (non-implant related) of an irradiated jaw
Soft-tissue radiation necrosis (e.g., radiation enteritis, cystitis, proctitis) and osteoradionecrosis
Systemic hyperbaric oxygen pressurization therapy as a primary treatment for profound anemia with exceptional blood loss is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Systemic hyperbaric oxygen pressurization therapy as an adjunctive procedure for the treatment of non-healing diabetic wounds of the lower extremities is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Systemic hyperbaric oxygen pressurization therapy for the treatment of other conditions including, but not limited to, the following is considered investigational:
Acute arterial peripheral insufficiency
Acute cerebral edema
Acute coronary syndromes
Acute radiation necrosis of the brain
Acute thermal burns
Autism spectrum disorders
Bone grafts
Brown recluse spider bites
Carbon tetrachloride poisoning
Cerebral Palsy
Cerebrovascular accident, acute
Chronic refractory osteomyelitis and acute osteomyelitis refractory to standard medical management
Compromised skin grafts or flaps
Delayed onset muscle soreness
Demyelinating diseases, e. g. multiple sclerosis, amyotrophic lateral sclerosis
Early treatment (during treatment and/or beginning at completion of radiation therapy up to one year following completion) to reduce side effects of radiation therapy
Fracture healing
Hydrogen sulfide poisoning
Idiopathic sudden sensorineural hearing loss
In vitro fertilization
Intra-abdominal and intracranial abscesses
Lepromatous leprosy
Meningitis
Migraine
Necrotizing soft tissue infections
Pseudomembranous colitis
Pyoderma gangrenosum
Refractory mycoses, mucormycosis, actinomycosis, canidobolus coronato
Retinal artery insufficiency, acute
Retinopathy
Severe or refractory Crohn's disease
Sickle cell crisis
Spinal cord injury
Traumatic brain injury
Tumor sensitization for cancer treatments
Topical hyperbaric oxygen pressurization therapy is considered investigational.
Transdermal sustained-delivery oxygen therapy is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Systemic hyperbaric oxygen therapy is considered medically appropriate if ANY ONE of the following criteria are met:
As a primary treatment, for profound anemia with exceptional blood loss if the blood transfusion is impossible or must be delayed
As an adjunctive procedure, for the treatment of non-healing diabetic wounds of the lower extremities if ALL of the following criteria are met:
A lower extremity wound that is due to diabetes, either type I or type II diabetes
The wound classified as Wagner grade 3 or higher
There are no measurable signs of healing after 30 days of an adequate course of standard wound therapy; examples include :
Assessment of an individual'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
Hyperbaric oxygen pressurization therapy is used in addition to continued standard wound care if ALL of the following criteria are met:
Individual is adherent to hyperbaric oxygen therapy
Evidence of improvement after 24 treatments
Individual has had fewer than 40 total treatments
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
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 or below the knee level) is indicated
No evidence was found to show clinical support for the use of hyperbaric oxygen pressurization therapy for the treatment of medical conditions or diseases other than those listed above.
No controlled studies were found in the published literature to validate the use of topical hyperbaric oxygen therapy or transdermal sustained-delivery oxygen therapy.
SOURCES
American Cancer Society. (2009, May). Hyperbaric oxygen therapy. Retrieved February 23, 2010 from http://www.cancer.org/docroot/ETO/content/ETO_5_3x_Hyperbaric_oxygen_therapy.asp?sitearea=ETO.
American College of Hyperbaric Medicine. (2009). What are the approved indications for hyperbaric oxygen therapy? Retrieved February 22, 2010 from http://www.achm.org/index.php/Resource-Library/Resource-Library/What-are-the-approved-indications-for-Hyperbaric-Oxygen-Therapy.html.
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2010). Hyperbaric Oxygen Pressurization (HBO2) (2.01.04). Retrieved October 14, 2010 from BlueWeb. (48 articles and/or guidelines reviewed)
Buettner, M. F., & Wolkenhauer, D. (2007). Hyperbaric oxygen therapy in the treatment of open fractures and crush injuries. Emergency Medicine Clinics of North America, 25 (1), 177-188.
Complete Guide to Medicare Coverage Issues [Computer software]. (2010, April). Hyperbaric oxygen (NCD 20.29, p. 2-27, 2-28). Ingenix.
Fife, C. E., Buyukcakir, C., Otto, G., Sheffield, P., Love, T., & Warriner, R. (2007). Factors influencing the outcome of lower-extremity diabetic ulcers treated with hyperbaric oxygen therapy. Wound Repair and Regeneration, 15 (3), 322-331. (Level I Evidence - Independent study)
Hampson, N. B., & Hauff, B. E. (2008). Risk factors for short-term mortality from carbon monoxide poisoning treated with hyperbaric oxygen. Critical Care Medicine, 36 (9), 2523-2527. (Level 1 Evidence - Independent study)
Kaide, C. G., & Khandelwal, S. (2008). Hyperbaric oxygen: Applications in infectious disease. Emergency Medicine Clinics of North America, 26 (2), 571-595.
Latham, E., Hare, M. A., & Neumeister, M. (2008). Hyperbaric oxygen therapy. Retrieved on October 5, 2009 from http://emedicine.medscape.com/article/1464149-print.
LeBas, J. (2009, May). Treating radiation necrosis of the brain. Retrieved February 23, 2010 from http://www2.mdanderson.org/depts/oncolog/articles/pf/09/5-may/5-09-2pf.html.
Melamed, Y., & Bitterman, H. (2009). Non-healing wounds and hyperbaric oxygen: A growing awareness. Israel Medical Association Journal, 11 (8), 498-500.
NHS Quality Improvement Scotland. (2008, July). HTA programme: Systematic review. The clinical and cost effectiveness of hyperbaric oxygen therapy. Retrieved February 22, 2010 from http://www.nhshealthquality.org/nhsqis/files/ClinicalGovernance_ClinicalAndCostEffectivenessOfHBOT_OCT08.pdf.
Rossignol, D. A., Rossignol, L. W., Smith, S., Schneider, C., Logerquist, S., Usman, A., et al. (2009). Hyperbaric treatment for children with autism: A multicenter, randomized, double-blind, controlled trial. BMC Pediatrics, 9 (21). (Level 2 Evidence - Industry sponsored)
Technology Evaluation Center. (1999, August). Hyperbaric oxygen therapy for wound healing - Part l. (Vol. 14, No. 13). Chicago: BlueCross BlueShield Association. (69 articles and/or guidelines)
Technology Evaluation Center. (1999, December). Hyperbaric oxygen therapy for wound healing - Part ll. (Vol. 14, No. 15). Chicago: BlueCross BlueShield Association. (94 articles and/or guidelines)
Technology Evaluation Center. (1999, December). Hyperbaric oxygen therapy for wound healing - Part lll. (Vol. 14, No. 16). Chicago: BlueCross BlueShield Association. (70 articles and/or guidelines)
U. S. Department of Health and Human Services. Office of Inspector General. (2000, October). Hyperbaric oxygen therapy. Its use and appropriateness. Retrieved March 29, 2010 from http://oig.hhs.gov/oei/reports/oei-06-99-00090.pdf.
U. S. Food and Drug Administration. (2006, March). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K053498. Retrieved February 23, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053498.pdf.
U. S. Food and Drug Administration. (2008, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K080966. Retrieved February 23, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K080966.pdf.
U. S. Food and Drug Administration. (2008, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K081506. Retrieved February 23, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081506.pdf.
Undersea & Hyperbaric Medical Society. (2007). Indications for hyperbaric oxygen therapy. Retrieved February 23, 2010 from http://www.uhms.org/Default.aspx?tabid=270.
Winifred S. Hayes, Inc. Medical Technology Directory. (2008, December). Hyperbaric oxygen therapy for carbon monoxide poisoning. Retrieved February 22, 2010 from www.Hayesinc.com/subscribers. (61 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2008, September). Hyperbaric oxygen therapy for burns, infections, and nondiabetic wounds. Retrieved February 22, 2010 from www.Hayesinc.com/subscribers. (54 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2008, September). Hyperbaric oxygen therapy for diabetic foot wounds. Retrieved February 22, 2010 from www.Hayesinc.com/subscribers. (50 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2009, July). Hyperbaric oxygen therapy for autistic disorder. Retrieved February 22, 2010 from www.Hayesinc.com/subscribers. (20 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2009, March). Hyperbaric oxygen therapy for osteoradionecrosis. Retrieved February 22, 2010 from www.Hayesinc.com/subscribers. (40 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2009, March). Hyperbaric oxygen therapy for soft tissue radiation injuries. Retrieved February 22, 2010 from www.Hayesinc.com/subscribers. (53 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 4/1980
MOST RECENT REVIEW DATE: 3/10/2011
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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