Public Statement: Medical Policy Statement:

Transcription

1 Medical Policy Title: Hyperbaric Oxygen ARBenefits Approval: Therapy Effective Date: Document: ARB0179:01 Revision Date: 02/08/2012 Code(s): Physician attendance and supervision of hyperbaric oxygen therapy, per session A4575 Topical hyperbaric oxygen chamber, disposable Public Statement: Administered by: 1) Hyperbaric oxygen therapy (HBOT) is a systemic treatment in which the entire patient is placed inside a pressurized chamber and breathes 100% oxygen under a pressure greater than one atmosphere. It is used to treat certain diseases and conditions that may improve when increased oxygen is present such as non-healing infected deep ulcerations, acute carbon monoxide poisoning, acute air or gas embolism, or radiation necrosis. 2) Continued treatment with HBOT for wound care is covered when there has been evidence of progressive healing during 30 days of treatment. 3) For certain conditions, HBOT is considered experimental since HBOT has not been shown to be more effective than conventional treatment. Examples: a) acute or chronic cerebrovascular insufficiency (low blood supply to the brain) b) cerebrovascular accident (including thrombotic or embolic stroke) 4) There are also conditions in which HBOT is dangerous and therefore, not a covered service such as: a) Untreated pneumothorax b) Concurrent administration of doxorubicin, cisplatin, or disulfiram c) Premature infants (birth prior to 37 weeks gestation) Medical Policy Statement: In the outpatient setting, full body hyperbaric oxygen therapy (HBOT) is considered medically necessary for the following conditions: 1. Non-healing infected deep ulcerations (reaching tendons or bone) of the lower extremity in diabetic adults unresponsive to at least 1 month of meticulous wound care (including aggressive debridement, maximal Page 1 of 7

2 antibiotic therapy, tight glycemic control, and appropriate treatment of arterial insufficiency, including revascularization if necessary). HBOT is not considered medically necessary for superficial lesions. 2. Acute carbon monoxide poisoning. 3. Decompression illness ( the bends ) the standard treatment is recompression and decompression without increased oxygen concentration in the air. 4. Acute air or gas embolism the standard treatment is recompression and decompression without increased oxygen concentration in the air. 5. Gas gangrene (Clostridial myositis and myonecrosis). 6. Cyanide poisoning (with co-existing carbon monoxide poisoning). 7. Acute traumatic peripheral ischemia (including crush injuries and suturing of severed limbs) when loss of function, limb, or life is threatened and HBOT is used in combination with standard therapy. 8. Acute peripheral arterial insufficiency (e.g., compartment syndrome). 9. Progressive necrotizing soft tissue infections, including mixed aerobic and anaerobic infections (necrotizing fasciitis, Meleney's ulcer). 10. Chronic refractory osteomyelitis, unresponsive to conventional medical and surgical management. 11. Compromised skin grafts and flaps. 12. Radiation necrosis (osteoradionecrosis, myoradionecrosis, and other soft tissue radiation necrosis) as an adjunct to conventional treatment. 13. Soft tissue radionecrosis as an adjunct to conventional wound care. 14. Exceptional blood loss anemia only when there is overwhelming blood loss and transfusion is impossible because there is no suitable blood available, or religion does not permit transfusions. 15. Pneumatosis cystoides intestinalis. 16. Prophylactic pre- and post-treatment for members undergoing dental surgery of a radiated jaw. 17. Acute cerebral edema. 18. Idiopathic sudden deafness, acoustic trauma or noise-induced hearing loss, when HBOT is initiated within 3 months after onset. 19. Necrotizing arachnidism (severe tissue destruction due to venomous spider bites) Limits: 1. HBOT is covered for wound care only when there have been no signs of healing following 30 days of standard wound care. 2. Continued treatment with HBOT for wounds is not covered when there have been no signs of healing after 30 days. 3. The use of HBOT is considered experimental and investigational for the following conditions because there is insufficient evidence in the medical literature establishing that HBOT is more effective than conventional therapies: Page 2 of 7

3 a. Actinomycosis and other mycoses b. Superficial and/or non-infected diabetic ulcers c. Non-diabetic cutaneous, decubitus, pressure and venous stasis ulcers d. Chronic peripheral vascular insufficiency e. Acute renal arterial insufficiency f. Acute or chronic cerebrovascular insufficiency/accident (including thrombotic or embolic stroke) g. Anaerobic septicemia and infection other than clostridial h. Aerobic septicemia and systemic aerobic infection i. Pyoderma gangrenosum j. Intra-abdominal abscess, pseudomembranous colitis (antibioticinduced colitis) k. Intracranial abscesses l. Skin burns (thermal) m. Acute thermal and chemical pulmonary damage, i.e., smoke inhalation (e.g., carbon tetrachloride, hydrogen sulfide) with pulmonary insufficiency n. Tetanus o. Organ transplantation and storage p. Pulmonary emphysema q. Cognitive impairment (e.g., senility, senile dementia) r. Non-vascular causes of chronic brain syndrome (e.g., Pick's disease, Alzheimer's disease, Korsakoff's disease) s. Multiple sclerosis t. Migraine or cluster headaches u. Meningitis v. Closed head and/or spinal cord injury w. Myocardial infarction x. Cardiogenic shock y. Sickle cell crisis or hematuria z. Radiation-induced cystitis, myelitis, enteritis, proctitis aa. Bone grafts or fracture healing (e.g., nonunion fractures) bb. cc. dd. ee. ff. gg. hh. ii. jj. kk. ll. mm. Arthritic diseases Ophthalmologic diseases (including diabetic retinopathy, retinal detachment, central retinal artery occlusion, radiation injury to the optic nerve, glaucoma, keratoendotheliosis) Hepatic necrosis Lepromatous leprosy Arthritis Avascular necrosis of the femoral head Cystic acne Melasma Actinic skin damage Lyme disease Cerebral palsy Reflex sympathetic dystrophy (complex regional pain syndrome). Page 3 of 7

4 nn. Bell's palsy oo. Legg-Calve Perthes disease pp. Crohn's disease qq. Osteoporosis rr. Cancer ss. HIV infection tt. Facial neuritis uu. Tinnitus vv. Interstitial cystitis. 4. HBOT is not covered for the following conditions as the safety of HBOT for these conditions has not been established. a. Untreated pneumothorax b. Concurrent administration of doxorubicin, cisplatin, or disulfiram c. Premature infants (birth prior to 37 weeks gestation). 5. Topical HBOT administered to the open wound in small limb-encasing devices is considered experimental and investigational because its efficacy has not been established through controlled clinical trials. Background: The literature states that HBOT should not be a replacement for other standard successful therapeutic measures. Depending on the response of the individual patient and the severity of the original problem, treatment may range from less than 1 week to several months' duration, the average being 2 to 4 weeks. HBOT treatment for more than 2 months is usually not necessary. HBOT has been shown to be an effective method for treating diabetic foot wounds in carefully selected cases of lower extremity lesions. Although the results of multiple retrospective studies involving a significant number of patients have consistently indicated a high success rate in patients who had been refractory to other modes of therapy, several recent prospective, randomized studies have only supported the adjunctive role of systemic hyperbaric oxygen therapy in the treatment of non-healing infected deep lower extremity wounds in patients with diabetes. Such evidence is lacking, however, for superficial diabetic wounds and non-diabetic cutaneous, decubitus, and venous stasis ulcers. Absolute contraindications to hyperbaric oxygen therapy include: untreated pneumothorax, concurrent administration of disulfuram (Antabuse); concurrent administration of the antineoplastic agents doxorubicin and cisplatinum; and administration to premature infants (due to risk of retrolental fibroplasia). Relative contraindications to the use of hyperbaric oxygen therapy include prior chest surgery, lung disease, viral infections, recent middle ear surgery, optic neuritis, seizure disorders, high fever, congenital spherocytosis, and claustrophobia. Page 4 of 7

5 Topical HBOT administered to the open wound in small limb-encasing devices is not systemic HBOT and its efficacy has not been established due to the lack of controlled clinical trials. In addition, in vitro evidence suggests that topical HBOT does not increase tissue oxygen tension beyond the superficial dermis. Examples of topical HBOT devices are TOPOX portable hyperbaric oxygen extremity and sacral chambers (Jersey City, NJ), Oxyboot and Oxyhealer from GWR Medical, L.L.P. (Chadds Ford, PA). Application to Products This policy applies to ARBenefits. Consult ARBenefits Summary Plan Description (SPD) for additional information. References 1. Arkansas BlueCross BlueShield, Coverage policy manual; Hyperbaric Oxygen Pressurization at: 2. Centers for Medicare and Medicaid Services, National coverage determinations; hyperbaric oxygen therapy at: all 3. The Undersea and Hyperbaric Medical Society (UHMS), Hyperbaric Oxygen Therapy Committee. Guidelines: Indications for Hyperbaric Oxygen. Kensington, MD: UHMS; Available at; 4. McDonagh M, Carson S, Ash J. Hyperbaric oxygen therapy for brain injury, cerebral palsy, and stroke. Rockville, MD: Agency for Healthcare Research and Quality (AHRQ); Bennett M, Heard R. Hyperbaric oxygen therapy for multiple sclerosis (Cochrane Review). In: The Cochrane Library, Issue 1, Chichester, UK: John Wiley & Sons, Ltd. 6. Juurlink DN, Stanbrook MB, McGuigan MA. Hyperbaric oxygen for carbon monoxide poisoning (Cochrane Review). In: The Cochrane Library, Issue 1, Chichester, UK: John Wiley & Sons, Ltd. 7. Coulthard P, Esposito M, Worthington HV, Jokstad A. Interventions for replacing missing teeth: Hyperbaric oxygen therapy for irradiated patients who require dental implants (Cochrane Review). In: The Cochrane Library, Issue 1, Chichester, UK: John Wiley & Sons, Ltd. 8. Greaves I, Porter K, Smith JE, et al. Consensus statement on the early management of crush injury and prevention of crush syndrome. J R Army Med Corps. 2003;149(4): Patterson J. Hyperbaric oxygen therapy for central retinal artery occlusion. Bazian Ltd., eds. London, UK: Wessex Institute for Health Research and Development, University of Southampton; Page 5 of 7

6 10. Dent THS. Hyperbaric oxygen therapy for carbon monoxide poisoning. Bazian Ltd., eds. London, UK: Wessex Institute for Health Research and Development, University of Southampton; Ball CM. Hyperbaric oxygen therapy for multiple sclerosis. Bazian Ltd., eds. London, UK: Wessex Institute for Health Research and Development, University of Southampton; Bisset F. Hyperbaric oxygen therapy in people with necrotising fasciitis or Fournier's gangrene. Bazian Ltd., eds. London, UK: Wessex Institute for Health Research and Development, University of Southampton; Kranke P, Bennett M, Roeckl-Wiedmann I, Debus S. Hyperbaric oxygen therapy for chronic wounds (Cochrane Review). In: The Cochrane Library, Issue 3, Chichester, UK: John Wiley & Sons, Ltd. 14. Villanueva E, Bennett MH, Wasiak J, Lehm JP. Hyperbaric oxygen therapy for thermal burns (Cochrane Review). In: The Cochrane Library, Issue 3, Chichester, UK: John Wiley & Sons, Ltd. 15. Lawson R. Hyperbaric oxygen for osteomyelitis. Bazian Ltd., eds. London, UK: Wessex Institute for Health Research and Development, University of Southampton; van Ophoven A, Rossbach G, Oberpenning F, Hertle L. Hyperbaric oxygen for the treatment of interstitial cystitis: Long-term results of a prospective pilot study. Eur Urol. 2004;46(1): Bennett MH, Kertesz T, Yeung P. Hyperbaric oxygen for idiopathic sudden sensorineural hearing loss and tinnitus. Cochrane Database Syst Rev. 2005;(1): CD Phillips JS, Jones SEM. Hyperbaric oxygen as an adjuvant treatment for malignant otitis externa [Protocol for Cochrane Review]. Cochrane Database Syst Rev. 2004;(1): CD Bennett M, Jepson N. Hyperbaric oxygen therapy for acute coronary syndrome [Protocol for Cochrane Review]. Cochrane Database Syst Rev. 2004;(3):CD Bennett MH, Wasiak J, French C, et al. Hyperbaric oxygen therapy for acute ischaemic stroke [Protocol for Cochrane Review]. Cochrane Database Syst Rev. 2004;(2): CD Bennett M, Babul S, Best TM, et al. Hyperbaric oxygen therapy for delayed onset muscle soreness and closed soft tissue injury [Protocol for Cochrane Review]. Cochrane Database Syst Rev. 2004;(2): CD Bennett MH, Feldmeier J, Hampson N, et al. Hyperbaric oxygen therapy for late radiation tissue injury [Protocol for Cochrane Review]. Cochrane Database Syst Rev. 2004;(2):CD Bennett MH, Stanford R, Turner R. Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union. Cochrane Database Syst Rev. 2005;(1): CD Bennett MH, Trytko B, Jonker B. Hyperbaric oxygen therapy for the adjunctive treatment of traumatic brain injury. Cochrane Database Syst Rev. 2004;(4):CD Page 6 of 7

7 25. Bennett M, Feldmeier J, Smee R, Milross C. Hyperbaric oxygenation for tumour sensitisation to radiotherapy [Protocol for Cochrane Review]. Cochrane Database Syst Rev. 2004;(1):CD Lueck C, McIlwaine G. Interventions for idiopathic intracranial hypertension. Cochrane Database Syst Rev. 2002;(3):CD Last Modified by: Date: Page 7 of 7