HCT Medical Policy. Hyperbaric Oxygen Therapy (HBOT) Policy # HCT114 Current Effective Date: 05/24/2016

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1 HCT Medical Policy Hyperbaric Oxygen Therapy (HBOT) Policy # HCT114 Current Effective Date: 05/24/2016 Medical Policies are developed by HealthyCT to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Medical Policy contains only a partial, general description of plan or program benefits and does not constitute a contract. HealthyCT does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of HealthyCT or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Medical Policy may be updated and therefore is subject to change. Policy Statement Hyperbaric oxygen therapy may be considered medically necessary and may be authorized up to 30 days and/or 30 treatments total for the following clinical indications: 1. As a primary treatment for any of the following: Carbon monoxide or cyanide poisoning; and Decompression sickness and air embolism; and Gas gangrene 2. As an adjunctive treatment* Acute traumatic peripheral ischemia when used in combination with accepted standard therapeutic measures when loss of function, limb, or life is threatened; and Progressive necrotizing infections (necrotizing fasciitis); and Crush injuries and suturing of severed limbs when loss of function, limb, or life is threatened; and Osteoradionecrosis; and Page 1 of 10

2 Chronic refractory osteomyelitis, unresponsive to conventional medical and surgical management Soft tissue radionecrosis; and Preparation and preservation of compromised skin grafts, preexisting grafts or flaps that are showing signs of failure or necrosis, (not for primary management of wounds) Diabetic wounds of the lower extremities when all of the following criteria are met: Diagnosis of type I or type II diabetes; and Presence of a wound classified as Wagner grade III or higher; and No response to an adequate course of standard wound therapy including all of the following: 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. *The use of HBO therapy as adjunctive therapy is defined as 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. Failure to respond to standard wound care occurs when there are no measurable signs of healing for at least 30 consecutive days. 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. 4. Topical hyperbaric oxygen therapy is considered experimental and investigational because the clinical efficacy has not been proven for any condition. 5. Hyperbaric oxygen therapy is considered not medically necessary for the following conditions because there is insufficient evidence in the peer reviewed medical literature. These conditions include but are not limited to: Page 2 of 10

3 Actinomycosis Acute coronary syndrome Acute ischemic stroke Acute migraine or cluster headaches Adjunctive treatment of traumatic brain injury Adjuvant treatment for malignant otitis media AIDS/HIV Alzheimer's Disease Ankle sprain or acute knee ligament injury Asthma Autistic disorder Bell's Palsy Brain Injury Cerebral palsy Depression Encephalopathy resulting from a drug overdose Fracture healing or nonunion fracture Heart Disease Hepatitis Idiopathic sudden sensorineual hearing loss and tinnitus Migraine Multiple Sclerosis Parkinson's Disease Spinal Cord Injury Sport's Injury Thermal skin burns Tumor sensitization to radiotherapy Overview According to the Undersea and Hyperbaric Medical Society, Hyperbaric Oxygen Therapy (HBOT) is a treatment in which a patient breathes near 100% oxygen intermittently while inside a treatment chamber at a pressure higher than sea level pressure (i.e., >1 atmosphere absolute; atm abs). Treatment can be carried out in either a mono or multiplace chamber. The former accommodates a single patient; the entire chamber is pressurized with near 100% oxygen, and the patient breathes the ambient chamber oxygen directly. The latter holds two or more people (patients, observers, and/or support personnel); the chamber is pressurized with compressed air while the patients breathe near 100% oxygen via masks, head hoods, or endotracheal tubes. Page 3 of 10

4 No standard protocol has been identified for HBO therapy sessions. Regardless of the type of chamber used, the interval between sessions and the total number of treatments varies according to the severity of the condition and physician preference. Treatment may begin with 1 to 3 treatments per day for up to 1 week and may continue daily for several days to several months. For each treatment, the pressure in the chamber is increased slowly and then held constant for 30 minutes to several hours. Topical oxygen therapy involves the application of gaseous oxygen to a cutaneous wound and can be administered on an outpatient basis in a clinic or medical office setting. To treat an affected hand or foot, a mitten or boot-shaped plastic bag with a gas inlet is attached to the arm or leg with adhesive tape, and the bag is then pumped full of pure oxygen. Cutaneous lesions that are not located on hands or feet can be treated with a plastic sheet that is sealed around the edges and then filled with oxygen. Regardless of the location of the lesion, oxygen is pumped into the bag or plastic sheet until the pressure reaches to 1.04 atmospheres, since the elevated pressure is believed to facilitate diffusion of oxygen into the wound. A pressurized bag sealed around an extremity can exert a tourniquet-like effect; during treatment, some practitioners continuously cycle bag pressure from full pressure to no pressure and back to full every 40 seconds to limit this effect. Treatment protocols vary somewhat but wounds are typically exposed to gaseous oxygen for 16 to 21 hours spread over 4 to 14 treatment sessions per week for 2 to 4 weeks. The FDA regulates hyperbaric oxygen (HBO) chambers as Class II medical devices, and there are a number of different chambers (both monoplace and multiplace chambers) that have been cleared for marketing via the 510(k) process (Product Code CBF, hyperbaric chamber). Devices that are not implantable and pose no risk of fatal outcome to the consumer should they malfunction are assigned Class II status and must meet FDA performance standards. Topical oxygen therapy devices are regulated by the FDA as Class II devices, and several devices have been approved via the FDA 510(k) process. Scientific Rationale Evidence in the published peer-reviewed literature and professional society guidelines support the safety and effectiveness of HBOT as a treatment for the following conditions: decompression illness, arterial or air gas embolism, cyanide and carbon monoxide poisoning, gas gangrene, necrotizing infections, soft tissue radionecrosis and osteoradionecrosis, non- Page 4 of 10

5 healing wounds in diabetes mellitus, skin grafts and flaps, acute traumatic ischemia or crush injuries and osteomyelitis. There is insufficient evidence in the published, peer-reviewed scientific literature to support systemic HBOT for any other indication. The published literature is from low quality studies and is generally in the form of case series and retrospective reviews with small heterogeneous patient populations, and short-term follow-ups that have reported conflicting and various outcome data. There is also insufficient evidence in the peer reviewed medical literature for any condition treated with topical oxygen therapy. Additionally, professional society guidelines do not support the safety and effectiveness of topical oxygen therapy. Professional society guidelines: The Undersea and Hyperbaric Medical Society recommends the following indications for systemic HBOT: 2 air or gas embolism carbon monoxide poisoning carbon monoxide poisoning complicated by cyanide poisoning central retinal artery occlusion clostridial myositis and myonecrosis (gas gangrene) crush injury, compartment syndrome, and other acute traumatic ischemia s decompression sickness enhancement of healing in select problem wounds exceptional blood loss (severe anemia) intracranial abscess necrotizing soft tissue infections osteomyelitis (refractory) delayed radiation injury (soft tissue and bony necrosis) skin grafts and flaps (compromised) thermal burns (acute) idiopathic sudden sensorineural hearing loss The American College of Hyperbaric Medicine recommends the following indications for systemic HBOT: 1 Air or Gas Embolism Page 5 of 10

6 Carbon Monoxide Poisoning Clostridial Myositis and Myonecrosis (Gas Gangrene) Crush Injury, Compartment Syndrome or other Acute Traumatic Ischemias Decompression Sickness Enhancement of Healing in Select Problem Wounds Extreme Anemia Intracranial Abscess Necrotizing Soft Tissue Infections Osteomyelitis (Refractory) Delayed Radiation Injury (Soft Tissue and Bony Necrosis) Skin Flaps & Grafts (Compromised) If sufficient data demonstrates that HBO therapy is associated with a favorable risk-benefit ratio for an indication, which is not currently on the approved list from the Centers for Medicare & Medicaid, the Undersea and Hyperbaric Medical Society or a Commercial Insurance Carrier, the ACHM will endorse the application of hyperbaric therapy for the supported indication. Indications that meet these criteria and are supported by the ACHM as appropriate for hyperbaric oxygen therapy include: 1 Acute Thermal Burns Acute Central Retinal Artery Occlusion Acute Frost Bite Actinomycosis (refractory and recalcitrant) Brown Recluse Spider Bite Idiopathic Sudden Sensorineural Hearing Loss Related Codes CPT Description Physician attendance and supervision of hyperbaric oxygen therapy, per session HCPCS A4575 G0277 E0446 Description Topical hyperbaric oxygen chamber, disposable Hyperbaric oxygen under pressure, full body chamber, per 30 minute interval Topical oxygen delivery system, not otherwise specified, includes all supplies and accessories Page 6 of 10

7 References 1. American College of Hyperbaric Medicine. Approved indications for hyperbaric oxygen Accessed at: 2. Undersea and Hyperbaric Medical Society. Indications for Hyperbaric Oxygen Therapy. UHMS; Accessed at: 3. Undersea and Hyperbaric Medical Society s (UHMS) Best Practice Guidelines, Hyperbaric Oxygen Committee. April, Accessed at: Committee/dcsandage_prevandmgt_uhms-fi.pdf 4. United States Navy Dive Manual, Revision 6. Treatment table 6. Page Accessed at: 5. U.S. Food and Drug Administration. 510K Summary of Safety and Effectiveness. Hyperbaric Oxygen Chamber. October, Accessed at: 6. U.S. Food and Drug Administration. Consumer Update. Hyperbaric Oxygen Therapy: Don't Be Misled. Aug, Accessed at: 7. McDonagh MS, Carson S, Ash JS. Et al. Hyperbaric oxygen therapy for brain injury, cerebral palsy, and stroke. Agency for Healthcare Research and Quality. September Number Raman G, Kupelnick B, Chew P, Lau J. A Horizon scan: Uses of hyperbaric oxygen. Technology Assessment Report. Agency for Healthcare Quality and Research. October, Accessed July 2012 at: 9. Bennett M, Jepson N, Lehm JP. Hyperbaric oxygen therapy for acute coronary syndrome. Cochrane database of Systematic Reviews 2009, Issue 4. Art No.:CD DOI: / CD pub Bennett M; Feldmeier J; Hampson N; Smee R; Milross C. Hyperbaric oxygen therapy for late radiation tissue injury. Cochrane Database Syst Rev 2009 ;(4):CD Bennett MH, Best TM, Babul-Wellar S, Taunton JE. Hyperbaric oxygen therapy for delayed onset muscle soreness and closed soft tissue injury. Cochrane Database of Systematic Reviews Updated, 2009, Issue 4. Art. No.: CD DOI: / CD pub Bennett MH, Feldmeier J, Smee R, Milross C. Hyperbaric oxygenation for tumor sensitization to radiotherapy. Cochrane Database of Systematic Reviews Updated September, 2008, Issue 4. Art.No.: CD DOI: / CD pub Bennett MH, French C, Schnabel A, Wasiak J, Kranke P. Normobaric and hyperbaric oxygen therapy for migraine and cluster headache. Cochrane Database of Systematic Reviews October 2009, Issue 3. Art. No.: CD DOI: / CD pub Bennett MH, Kertesz T, Yeung P. Hyperbaric oxygen for idiopathic sudden sensorineural hearing loss and tinnitus. Cochrane Database of Systematic Reviews Update 2009, Issue 1. Art.No.: CD DOI: / CD pub3. Page 7 of 10

8 15. Bennett MH, Lehm JP, Jepson N. Hyperbaric oxygen therapy for acute coronary syndrome. Cochrane Database of Systematic Reviews Updated July, 2007, Issue 2. Art. No.: CD DOI: / CD pub Bennett MH, Lehm JP, Mitchell SJ, Wasiak J. Recompression and adjunctive therapy for decompression illness. Cochrane Database of Systematic Reviews 2007, Issue 2. Art No. CDOO5277. DOI: / CD pub2 17. Bennett MH, Stanford R, Turner R. Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union. Cochrane Database of Systematic Reviews 2009, Issue 4 Art No: CD DOI: / CD pub2 18. Bennett MH, Stanford RE, Turner R. Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union. Cochrane Database of Systematic Reviews Updated July, 2008, Issue 1. Art. No.: CD DOI: / CD pub Bennett MH, Trytko B, Jonker B. Hyperbaric oxygen therapy for the adjunctive treatment of traumatic brain injury. Cochrane Database of Systematic Reviews January, 2009 Update, Issue 4. Art.No.: CD DOI: / CD pub Bennett MH, Wasiak J, Schnabel A, Kranke P, French C. Hyperbaric oxygen therapy for acute ischemic stroke. Cochrane Database of Systematic Reviews 2009, Issue 4. Art No.: CD004954, DOI: / CD pub Bennett MH, Wasiak J, Schnabel A, Kranke P, FrenchC. Hyperbaric oxygen therapy for acute ischemic stroke. Cochrane Database of Systematic Reviews 2005, December, 2008 Update. Issue 3. Art. No.: CD DOI: / CD pub Buckley NA, Juurlink DN et al. Hyperbaric Oxygen for carbon monoxide poisoning. Cochrane Database Syst Rev Apr 13;(4):CD Eskes A, Ubbink DT et al. Hyperbaric oxygen therapy for treating acute surgical and traumatic wounds. Cochrane Database Syst Rev Oct 6;(10):CD Juurlink DN, Buckley NA, Stanbrook MB et al. Hyperbaric oxygen for carbon monoxide poisoning. The Cochrane Database of Systematic Reviews, 2009, Issue 4. Art No. CD DOI: / CD pub2 25. Kranke P, Bennett MH et al. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev Apr 18;4:CD Philips JS, Jones S. Hyperbaric oxygen as an adjuvant treatment for malignant otitis externa. Cochrane Database of Systematic ReviewsOctober, 2008 Issue 4. Art. No.: CD DOI: / CD pub2 27. Phillips JS, Jones SEM. Hyperbaric oxygen as an adjuvant treatment for malignant otitis externa. Cochrane Database of Systematic Reviews 2005, Updated October 2008 Issue 2. Art. No.: CD DOI: / CD pub Villanueva E, Bennett M, Wasiak J, Lehm J. Hyperbaric oxygen therapy for thermal burns. Cochrane Database Systematic Review 2004;3:CD Clarke RE, 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 Radiat Oncol Biol Phys. 2008;72(1): 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): Page 8 of 10

9 31. Rossignol DA, Rossignol LW, Smith S, et al. Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial. BMC Pediatrics. 2009;9: Roeckl-Wiedmann I, Bennett M, Kranke P. Systematic review of hyperbaric oxygen in the management of chronic wounds. Br J Surg. 2005;92(1): Weaver LK, Hopkins RO, Chan, KJ, et al. Hyperbaric oxygen for acute carbon monoxide poisoning. New Engl J Med. 2002;347(14): Guo S, Counte MA, Romeis JC. Hyperbaric oxygen technology: an overview of its applications, efficacy, and cost-effectiveness. Int J Technol Assess Health Care. 2003;19(2): Wang C, Schwaitzberg S, Berliner E, et al. Hyperbaric oxygen for treating wounds: a systematic review of the literature. Arch Surg. 2003;138(3): Chau JK, Lin JR, Atashband S, Irvine RA, Westerberg BD. Systematic review of the evidence for the etiology of adult sudden sensorineural hearing loss. Laryngoscope. 2010;120: Annane D, Chadda K, Gajdos P, Jars-Guincestre MC, Chevret S, Raphael JC. Hyperbaric oxygen therapy for acute domestic carbon monoxide poisoning: two randomized controlled trials. Intensive Care Med Mar;37(3): Esposito M, Worthington HV. Interventions for replacing missing teeth: hyperbaric oxygen therapy for irradiated patients who require dental implants. Cochrane Database of Systematic Reviews 2013, Issue 9. Art. No.: CD DOI: / CD pub3 39. Xiao Y, Wang J, Jiang S, Luo H. Hyperbaric oxygen therapy for vascular dementia. Cochrane Database of Systematic Reviews 2012, Issue 7. Art. No.: CD DOI: / CD pub2 40. Holland NJ, Bernstein JM, Hamilton JW. Hyperbaric oxygen therapy for Bell's palsy. Cochrane Database of Systematic Reviews 2012, Issue 2. Art. No.: CD DOI: / CD pub2 41. Bennett M, et al. Hyperbaric oxygen for acute coronary syndrome. Cochrane Database Syst Rev 2015, Issue 7. Art. No CD Bennett MH, et al. Hyperbaric oxygen therapy for acute ischaemic stroke. Cochrane Database Syst Rev 2014 Nov 12;11:CD Bennett M, et al. Hyperbaric oxygen therapy for the adjunctive treatment of traumatic brain injury. Cochrane Database Syst Rev 2012 Dec 12;(12):CD Bennett MH, et al. Normobaric and hyperbaric oxygen therapy for migraine and cluster headache. Cochrane Database of Systematic Reviews 2015, Issue 12. Art. No.: CD Liu R, et al. Systematic review of the effectiveness of hyperbaric oxygenation therapy in the management of chronic diabetic foot ulcers. Mayo Clin Proc 2013 Feb;88(2): Document History Date Action 12/9/2014 Original Version 9/14/2015 Replaced C1300 with G0277 Page 9 of 10

10 Annual Review. Additional scientific rationale added; last paragraph. References 04/15/2016 #41-45 added 05/24/16 Updates reviewed and approved at UMC Page 10 of 10