Hyperbaric Oxygen Therapy

POLICY NUMBER

L.2.01.412

DESCRIPTION

Hyperbaric Oxygen Therapy

Hyperbaric oxygen therapy (HBOT) is a technique of delivering higher pressures of oxygen to tissue. Two methods of administration are available: topical and systemic.

Topical Hyperbaric Oxygen TherapyTopical 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. 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 lesions, decubitus ulcers, amputations, skin grafts, burns, or frostbite.

Systemic Hyperbaric Oxygen TherapyIn systemic or large chamber hyperbaric oxygen chambers, the patient is entirely enclosed in a pressure chamber and breathes oxygen at a pressure greater than one atmosphere (the pressure of oxygen at sea level). Thus, this technique relies on the systemic circulation to deliver highly oxygenated blood to the target site, typically a wound. Systemic hyperbaric oxygen therapy can be used to treat systemic illness, such as air or gas embolism, carbon monoxide poisoning, clostridial gas gangrene. 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.

Adverse Events

HBOT is a generally safe therapy, with an estimated adverse side effect rate of 0.4%. Adverse events may occur either from pressure effects or the oxygen. The pressure effect (barotrauma) may affect any closed air-filled cavity such as ears, sinus, teeth, and lungs. Pain and/or swelling may occur at these sites as pressure increases during the procedure and decreases as the procedure is ending. Oxygen toxicity may affect the pulmonary, neurologic, or ophthalmologic systems. Pulmonary symptoms include a mild cough, substernal burning, and dyspnea. Neurologic effects include tunnel vision, tinnitus, nausea, and dizziness. Ophthalmologic effects include retinopathy in neonates, cataract formation, and transient myopic vision changes.

POLICY

I. Topical hyperbaric oxygen therapy is considered investigational.

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

• Non-healing diabetic wounds of the lower extremities in patients who meet all of the following 3 criteria:

• Patient has type 1 or type 2 diabetes and has a lower-extremity wound that is due to diabetes, and

• Patient has a wound classified as Wagner grade 3 or higher*; and

• Patient has no measurable signs of healing after 30 days of an adequate course of standard wound therapy

• Acute traumatic ischemia (e.g., crush injury, reperfusion injury, compartment syndrome)

• Decompression sickness

• Gas embolism, acute

• Cyanide poisoning, acute

• Soft-tissue radiation necrosis (e.g., radiation enteritis, cystitis, proctitis) and osteoradionecrosis

• Pre- and post-treatment for patients undergoing dental surgery (non-implant related) of an irradiated jaw

• Gas gangrene (i.e., clostridial myonecrosis)

• Profound anemia with exceptional blood loss only when blood transfusion is impossible or must be delayed, or when loss can be due to homolysis exsanguination

• Acute carbon monoxide poisoning

• Chronic refractory osteomyelitis

* The Wagner classification system of wounds is defined as follows:

III. Systemic hyperbaric oxygen pressurization is considered investigational in all other situations, including but not limited to, the treatment of the following conditions:

• Compromised skin grafts or flaps

• Acute osteomyelitis

• Necrotizing soft-tissue infections

• Acute thermal burns

• Acute surgical and traumatic wounds

• Chronic wounds, other than those in patients with diabetes who meet the criteria specified in the medically necessary statement

• Spinal cord injury

• Traumatic brain injury

• Inflammatory bowel disease (Crohn disease or ulcerative colitis)

• Brown recluse spider bites

• Bone grafts

• Carbon tetrachloride poisoning, acute

• Cerebrovascular disease, 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

• 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

• In vitro fertilization

• Cerebral palsy

• Tumor sensitization for cancer treatments, including but not limited to, radiotherapy or chemotherapy

• Delayed-onset muscle soreness

• Idiopathic femoral neck necrosis

• Chronic arm lymphedema following radiotherapy for cancer

• Radiation-induced injury in the head and neck, except as noted earlier in the medically necessary statement

• Early treatment (beginning at completion of radiotherapy) to reduce adverse effects of radiotherapy

• Autism spectrum disorder

• Acute ischemic stroke

• Bell’s palsy

• Bisphosphonate-related osteonecrosis of the jaw

• Motor dysfunction associated with stroke

• Herpes zoster

• Vascular dementia

• Fibromyalgia; and

• Mental illness (ie, posttraumatic stress disorder, generalized anxiety disorder or depression)

The following criteria taken from The Undersea and Hyperbaric Medical Society’s 1996 Hyperbaric Oxygen Therapy Committee may be used as a guideline for Systemic Hyperbaric Oxygen utilization:

Coverage:

• All medically necessary indications will be allowed for the first 20 treatments

• Coverage for additional benefits beyond this will only be allowed if there is written documentation in the patient's chart of wound healing and improvement (e.g., new tissue growth, shrinkage of ulcer, etc.)

• Reassessments and written documentation of continued wound healing must be done, at a minimum, every two (2) weeks

• Benefits will not be provided beyond a 3 month period

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

As specified in CPT code 99183, physician attendance and supervision of hyperbaric oxygen therapy is required.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

3/1993: Approved by Medical Policy Advisory Committee (MPAC).

2/1997: Revision approved by MPAC. Thermal Burns, necrotic wounds to brown recluse spider bite and multiple sclerosis moved to investigational status. Required documentation after twenty (20) treatment limit and three (3) month maximum added.

5/2000: Revision approved by MPAC; soft tissue infections moved to investigational status and topical HBO2 added to investigational status. Undersea and Hyperbaric Medical Society's HBO therapy utilization guidelines added.

1/29/2001: HCPCS G0167 added covered codes.

1/23/2002: Prior authorization deleted.

2/7/2002: Investigational definition added.

5/1/2002: Type of Service and Place of Service deleted.

5/28/2002: Code Reference section updated, ICD-9 diagnosis code 784.5 should be 785.4, ICD-9 diagnosis code 383.20, 447.8, 454.0, 454.2, 459.89 added covered codes, ICD-9 diagnosis code 707.10, 707.11, 707.12, 707.13, 707.14, 707.15, 707.19, 707.8, 707.9 added non-covered codes, HCPCS A4575, A4619, E1390, E1391, E1399, E1405, E1406 added covered codes.

9/20/2002: Policy reviewed, Hayes report number added.

11/11/2002: HCPCS A4575 moved from covered codes to non-covered codes, Hayes report number deleted.

3/10/2004: Code Reference section updated, invalid ICD-9 diagnosis code 929.99 deleted covered codes, ICD-9 diagnosis code 707.10, 707.11, 707.12, 707.13, 707.14, 707.15, 707.19, 707.8, 707.9 moved from non-covered codes to covered codes.

11/5/2004: Code Reference section updated, ICD-9 procedure code 93.59 added non-covered codes, ICD-9 diagnosis code 006.5, 013.30, 013.31, 013.32, 013.33, 013.34, 013.35, 013.36, 030.0, 282.62, 320.0, 320.1, 320.2, 320.3, 320.7, 320.81, 320.82, 320.89, 320.9, 321.0, 321.1, 321.2, 321.3, 321.4, 321.8, 322.0, 322.1, 322.2, 322.9, 323.9, 324.0, 324.9, 326, 340, 361.00, 361.01, 361.02, 361.03, 361.04, 361.05, 361.06, 361.07, 361.2, 361.81, 361.89, 361.9, 362.60, 362.61, 362.62, 362.63, 362.64, 362.65, 362.66, 435.8, 436, 540.1, 556.2, 558.9, 569.5, 569.61, 572.0, 590.2, 599.7, 686.00, 686.01, 686.09, 776.5, 777.5, 800.00-800.99, 801.00-801.99, 802.0-802.9, 803.00-803.99, 804.00-804.99, 850.0-850.9, 851.00-851.99, 852.00-852.59, 853.00-853.19, 854.00-854.19, 940.0-940.9, 941.00-941.09, 941.10-941.19, 941.20-941.29, 941.30-941.39, 941.40-941.49, 941.50-941.59, 942.00-942.09, 942.10-942.19, 942.20-942.29, 942.30-942.39, 942.40-942.49, 942.50-942.59, 943.00-943.09, 943.10-943.19, 943.20-943.29, 943.30-943.39, 943.40-943.49, 943.50-943.59, 944.00-944.08, 944.10-944.18, 944.20-944.28, 944.30-944.38, 944.40-944.48, 944.50-944.58, 945.00-945.09, 945.10-945.19, 945.20-945.29, 945.30-945.39, 945.40-945.49, 945.50-945.59, 946.0-946.5, 947.0-947.9, 948.00-948.99, 949.0-949.5, 952.00-952.9, 959.01, 982.1, 985.1, 996.4, V12.59 deleted non-covered codes, HCPCS G0167 deletion date of 12/31/2004 added.

9/19/2005: ICD-9 procedure code 93.59 moved from non-covered to covered codes.

5/24/2006: G0167 deleted 12-31-2003. Code removed from the covered table.

9/12/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy.

11/29/2006: The following are now listed as investigational: amyotrophic lateral sclerosis; compromised skin grafts or flaps; chronic refractory osteomyelitis and acute osteomyelitis, refractory to standard medical management; delayed onset muscle soreness; acute cerebral edema; refractory mycoses: mucormycosis, actinomycosis, canidiobolus coronato; radiation necrosis (osteoradionecrosis and soft tissue radiation necrosis); 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 sensorneural hearing loss; migraine; in vitro fertilization; cerebral palsy; tumor sensitization for cancer treatments, including but not limited to, radiotherapy or chemotherapy. Removed "Radiation necrosis - utilization review is required after 60 treatments. Treatments are usually given daily for 90 to 120 minutes" from policy section.

11/30/2006: Code Reference section updated. Deleted the following ICD-9 codes: 039.0-039.9, 090.0, 095.5, 111.0-111.9, 112.0, 112.1, 112.2, 112.3, 117.9, 348.5, 376.03, 383.20, 526.5, 526.89, 682.0-682.9, 686.00-686.09, 686.1, 686.8, 686.9, 730.00-730.29, 730.80-730.89, 767.8, 990, 996.52, and 996.79.

3/19/2008: Soft tissue radiation necrosis and osteoradionecrosis changed from investigational to medically necessary. Added pre- and post treatment for dental surgery of an irradiated jaw may be considered medically necessary. Code reference section updated; ICD-9 codes 526.89, 909.2, and 909 added to covered table.

7/17/2008: Reviewed and approved by MPAC.

9/17/2008: Annual ICD-9 updates effective 10-1-2008 applied.

12/1/2009: Policy Statement Section revised as follows: Hyperbaric oxygen pressurization is now not medically necessary for the treatment of acute carbon monoxide poisoning. Venous stasis ulcers and arterial insufficiency ulcers removed from medically necassary conditions. Additional criteria and Wagner classification system of wounds added to medically necessary criteria for non-healing diabetic wounds. Severe or refactory Crohn's disease added to investigational criteria. The Undersea and Hyperbaric Medical Society guideline updated with radiation necrosis information. Policy Exceptions Section revised to include FEP verbiage. Policy Coding Section revised as follows: ICD9 diagnosis codes 447.8, 454.0, 454.2, 459.89, 707.8, 707.9 removed from Covered Codes Table. ICD9 diagnosis code 986 moved to Non-Covered Codes Table, ICD9 Diagnosis Code 040.42 added to Covered Codes Table. HCPCS codes A4619, A4620, E0455, E1390, E1399, E1405, E1406 removed from Covered Codes Table.

09/09/2010: Policy statement revised to indicate that HBO for acute carbon monoxide poisioning and chronic refractory osteomyelitis may be considered medically necessary. Added ICD-9 codes 730.00-730.19 to the Covered Codes table. Moved ICD-9 code 986 from non-covered to covered.

11/10/2011: Add the following as investigational indications for HBO: acute surgical and traumatic wounds, idiopathic femoral neck necrosis, chronic arm lymphedema following radiotherapy for cancer, radiation-induced injury in the head and neck, early treatment (beginning at completion of radiation therapy) to reduce adverse effects of radiation therapy, and autism spectrum disorders.

09/27/2012: Policy statement revised to add the following indications as investigational: acute ischemic stroke, Bell’s palsy, and chronic wounds, other than those in patients with diabetes who meet the criteria specified in the medically necessary statement. Added reperfusion injury, compartment syndrome as examples of acute traumatic ischemia.

11/15/2013: Policy statement revised to add the following indications as investigational: Bisphosphonate-related osteonecrosis of the jaw, motor dysfunction associated with stroke, herpes zoster, and vascular dementia.

12/31/2014: Added the following new 2015 CPT code(s) to the Code Reference section: G0277.

05/04/2015: Investigational policy statement for hyperbaric oxygen pressurization revised to change "Acute osteomyelitis, refractory to standard medical management" to "Acute osteomyelitis."

08/27/2015: Code Reference section updated to add ICD-10 codes. Changed ICD-9 diagnosis code range 730.00 – 730.19 to 730.10 – 730.19 for chronic osteomyelitis.

09/29/2015: Code Reference section updated to add ICD-9 diagnosis codes 558.1 and 595.82.

11/23/2015: Code Reference section updated to include the "D" suffix codes for subsequent encounters for the applicable code ranges.

04/26/2016: Policy Guidelines updated to add medically necessary and investigative definitions.

06/06/2016: Policy number L.2.01.412 added.

09/29/2017: Code Reference section updated to add new ICD-10 diagnosis codes L97.105, L97.106, L97.108, L97.115, L97.116, L97.118, L97.125, L97.126, L97.128, L97.205, L97.206, L97.208, L97.215, L97.216, L97.218, L97.225, L97.226, L97.228, L97.305, L97.306, L97.308, L97.315, L97.316, L97.318, L97.325,  L97.326, L97.328, L97.405, L97.406, L97.408, L97.415, L97.416, L97.418, L97.425, L97.426, L97.428, L97.505, L97.506, L97.508, L97.515, L97.516, L97.518, L97.525, L97.526, L97.528, L97.806, L97.808, L97.815, L97.816, L97.818, L97.825, L97.826, L97.828, L97.905, L97.906, L97.908, L97.915, L97.916, L97.918, L97.925, L97.926, and L97.928. Effective 10/01/2017.

02/14/2018: Policy title changed from "Hyperbaric Oxygen (HBO) Pressurization" to "Hyperbaric Oxygen Therapy." Policy description updated. Investigational statement regarding hyperbaric oxygen pressurization updated with the following changes: 1) added "including but not limited to" wording; 2) "Severe or refractory Crohn's disease" changed to "Inflammatory bowel disease (Crohn disease or ulcerative colitis);" 3) added clarification for radiation-induced injury in the head and neck; 4) "radiation therapy" changed to "radiotherapy;" and 5) added fibromyalgia and mental illness (ie, posttraumatic stress disorder, generalized anxiety disorder or depression) as investigational.

04/12/2019: Policy reviewed; no changes.

12/20/2019: Code Reference section updated to add ICD-10 diagnosis code M27.2.

04/06/2022: Policy description updated regarding adverse events. Third policy statement updated to add "systemic" to hyperbaric oxygen pressurization. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

12/12/2022: Policy reviewed; no changes.

10/27/2023: Policy reviewed; no changes.

SOURCE(S)

1. Blue Cross Blue Shield Association policy # 2.01.04

2. Hayes Medical Technology Directory

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Investigational Codes 

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.