Humana Hyperbaric Oxygen Therapy, Topical Oxygen Therapy Form

DescriptionDuring hyperbaric oxygen therapy (HBOT), an individual is placed in a specially designed chamber that is pressurized to greater than sea level (one atmosphere absolute [1 ATA]) and breathes near 100% oxygen. The result of this direct pressure and hyperoxygenation is an increase in alveolar oxygen and a rise in dissolved plasma oxygen content promoting enhanced tissue oxygen delivery and healing. Other purported benefits of therapy include antimicrobial activity, attenuation of reperfusion injury, neovascularization and vasoconstriction.

Treatment may take place in a monoplace chamber or a multiplace chamber. The monoplace chamber accommodates one individual in the supine position and is pressurized with 100% oxygen, allowing the ambient chamber air to be inhaled directly. A multiplace chamber accommodates two or more individuals where the ambient pressurized atmosphere is normal air. Individual receives 100% oxygen through an endotracheal tube, hood or mask. The advantage of a multiperson chamber is that specially trained personnel may accompany the individual in the chamber and provide necessary treatments and care during the HBOT session. Regardless of which type of chamber is used, the amount of pressure and the length of time under pressure are determined by the condition being treated. Treatment pressures are usually between two to three times ATA and may last from one to two hours at full pressure.

HBOT is used to treat certain conditions or diseases that may respond to increased tissue oxygenation when baseline tissue oxygen levels are too low for spontaneous healing. HBOT is indicated as primary treatment for some conditions; however, it may also serve as adjunctive therapy for other treatment modalities.

Topical oxygen therapy (also known as continuous diffusion of oxygen [CDO] therapy) involves direct application of 100% oxygen to promote wound healing. Examples of topical oxygen therapy systems include, but may not be limited to, the EPIFLO, Hyper-Box, TransCu O2 and VHT-200 system. (Refer to Coverage Limitations section)

Coverage Determination

HBOT treatments are required five times per week to optimize treatment response.

Humana members may be eligible under the plan for HBOT as primary treatment for the following indications:

• Acute carbon monoxide intoxication (poisoning); OR
• Air or gas embolism; OR
• Decompression illness; OR
• Severe anemia due to aplasia, hemolysis or hemorrhage when transfusion is refused or delayed

Hyperbaric Oxygen Therapy, Topical Oxygen Therapy Effective Date: 05/25/2023 Revision Date: 05/25/2023 Review Date: 05/25/2023 Policy Number: HUM-0450-027 Page: 3 of 17

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Humana members may be eligible under the plan for HBOT as adjunctive treatment for the following indications:

• Acute peripheral arterial insufficiency (ALWAYS requires review by a medical director) with documentation of the following:
  • Operative report to confirm lysis/removal of clot/embolus; AND
  • Vascular study that confirms vessel obstruction by clot/embolus and location; OR
• Acute thermal burn injury; OR
• Acute traumatic peripheral ischemia when loss of function, limb or life is threatened; OR
• Central retinal artery occlusion (confirmed by ophthalmologic evaluation) within 24 hours of symptom onset (ALWAYS requires review by a medical director after three HBOT sessions to evaluate treatment response); OR
• Chronic refractory osteomyelitis (CROM) unresponsive to antibiotic therapy and surgical management (ALWAYS requires review by a medical director) with the following documentation:
  • Bone culture or X-ray confirmation of osteomyelitis; AND
  • Completion of parenteral antibiotic course (approximately six weeks); AND
  • Date of acute onset of osteomyelitis; AND
  • Surgical eradication (debridement/removal of small, nonweight bearing bone) or evidence that site is not amenable to surgical intervention; OR
• Clostridial myositis and myonecrosis (gas gangrene); OR
• Compartment syndrome; OR

Hyperbaric Oxygen Therapy, Topical Oxygen Therapy Effective Date: 05/25/2023 Revision Date: 05/25/2023 Review Date: 05/25/2023 Policy Number: HUM-0450-027 Page: 4 of 17

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

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• Crush injuries and reattachment of severed limbs when loss of function, limb or life is threatened; OR
• Cyanide poisoning when primary antidote (or treatment) has failed or is unavailable; OR
• Delayed soft tissue radiation injury (eg, radiation cystitis, radiation proctitis, laryngeal necrosis) (ALWAYS requires review by a medical director) with documentation of diagnosis (eg, endoscopy/cystoscopy report) from a specialist (eg, urologist, gastroenterologist or otolaryngologist); OR
• Diabetic wound(s) of the lower extremities (ALWAYS requires review by a medical director) with the following documentation:
  • Color digital photograph(s) with ruler of wound(s) for initial request and upon request for continuation of coverage for HBOT; AND
  • Failed an adequate course of standard wound therapy (minimum of 30 consecutive days) without measurable signs of healing for a Wagner grade 3 through 5 diabetic wound32; OR
• Idiopathic sudden sensorineural hearing loss as an adjunctive treatment to systemic or intratympanic steroid therapy with documentation of diagnosis from a specialist (eg, otolaryngologist) when the following criteria are met:
  • At least three consecutive frequencies are affected with no identifiable cause2; AND
  • Decrease in hearing of greater than or equal to 30 decibels (dB)2; OR
• Intracranial abscess (ALWAYS requires review by a medical director) with the following documentation:
  • Multiple abscesses are present in a deep or dominant location; AND

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Unresponsive to intravenous antibiotic therapy AND surgical management (except when surgery is contraindicated or the individual is a poor surgical risk); OR
• Osteoradionecrosis (ORN) for an individual undergoing dental surgery involving a previously irradiated jaw (ALWAYS requires review by a medical director) with the following documentation:
  • Documentation of relationship between extraction site and radiation portal (prior to image-guided or intensity-modulated radiation therapy); AND
  • Planned use of MARX protocol29 for five days per week, as follows:
    • Treatment for prophylaxis of ORN: 20 HBOT sessions preoperatively, followed by 10 sessions immediately postoperatively; OR
    • Treatment for established ORN:
      • Stage I: 30 HBOT sessions prior to bony debridement, followed by 10 sessions immediately postoperatively; OR
      • Stage II (failure of treatment for stage I or newly diagnosed stage II): 30 HBOT sessions prior to radical surgical debridement (maintaining mandibular continuity), followed by 10 sessions immediately postoperative; OR
      • Stage III (failure of treatment for stages I and/or II or newly diagnosed stage III): 30 HBOT sessions prior to mandibular resection, followed by 10 sessions immediately postoperative. May need an additional 10 sessions to support initial tissue metabolic demands if reconstruction of the mandible occurs; OR
• Preparation and preservation of compromised flap (ALWAYS requires review by a medical director) with documentation of operative reports for initial flap procedure AND of surgical exploration that failed to resolve cause of flap failure (e.g., occluded vessel, kinked pedicle); OR
• Preparation and preservation of compromised skin grafts (excluding artificial skin grafts) (ALWAYS requires review by a medical director); OR
• Progressive soft-tissue necrotizing infections (necrotizing fasciitis) unresponsive to intravenous antibiotic therapy and documentation of surgical management/ operative report (ALWAYS requires review by a medical director)

Continuation of Coverage for HBOT

All conditions or wounds must be evaluated by a medical director at least every 30 days during administration of HBOT. Diabetic wound(s) of the lower extremities must have color digital photograph(s) with ruler submitted with requests for continuation of coverage. Continued treatment with HBOT is considered not medically necessary if measurable signs of healing have not been demonstrated within any 30-day period of treatment.

Note: The criteria for HBOT are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website at CMS website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for HBOT for any indications other than those listed above including, but not limited to:

• Actinomycosis; OR
• AIDS/HIV; OR
• Alzheimer disease; OR
• Anorectal conditions (e.g., fissures and fistulas); OR
• Arthritic diseases; OR
• Asthma; OR
• Autism spectrum disorders (ASD); OR
• Avascular necrosis (AVN) (osteonecrosis); OR
• Bell’s palsy; OR
• Brain injury; OR

Hyperbaric Oxygen Therapy, Topical Oxygen Therapy Effective Date: 05/25/2023 Revision Date: 05/25/2023 Review Date: 05/25/2023 Policy Number: HUM-0450-027 Page: 7 of 17

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled.

Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Calciphylaxis (calcific uremic arteriolopathy); OR
• Cancer; OR
• Cerebral palsy; OR
• Cognitive impairment; OR
• Cutaneous nondiabetic ulcers; OR
• Decubitus ulcers, also known as pressure injuries; OR
• Depression; OR
• Heart disease; OR
• Hepatitis; OR
• Inflammatory bowel disease (IBD) (eg, ulcerative colitis); OR
• Lupus vasculitis; OR
• Migraine; OR
• Multiple sclerosis; OR
• Myocardial infarction; OR
• Parkinson’s disease; OR
• Post concussion syndrome; OR
• Pulmonary emphysema; OR
• Sickle cell anemia; OR
• Spinal cord injury; OR
• Sports injury; OR
• Stroke; OR
• Tetanus; OR
• Tinnitus; OR
• Venous stasis (venous insufficiency) ulcers

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for topical oxygen therapy for any indication. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Hyperbaric Oxygen Therapy, Topical Oxygen Therapy Effective Date: 05/25/2023
Revision Date: 05/25/2023
Review Date: 05/25/2023
Policy Number: HUM-0450-027 Page: 8 of 17

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Note:

The criteria for topical oxygen therapy are consistent with the Medicare National Coverage Policy, and therefore apply to Medicare members.

Background

Additional information about cardiovascular disease, decompression illness, infections, poisoning and wounds may be found from the following websites:

• American Association of Poison Control Centers;
• American Diabetes Association;
• American Heart Association;
• Centers for Disease Control and Prevention;
• National Library of Medicine;
• Undersea & Hyperbaric Medical Society

Medical Alternatives

Alternatives to HBOT include, but may not be limited to, the following:

• Assessment of vascular status and correction of vascular problems
• Negative pressure wound therapy (please refer to Negative Pressure Wound Therapy Medical Coverage Policy)
• Prescription drug therapy
• Surgical management

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes when developing a patient treatment plan.