Medical Necessity of Hyperbaric Oxygen Therapy

The Plan considers Systemic Hyperbaric Oxygen Therapy (HBOT) medically necessary when the criteria below for certain medical conditions are met for a prior authorization review. According to the Undersea and Hyperbaric Medical Society, hyperbaric oxygen therapy applies an increased pressure of ≥1 atmosphere absolute at sea level with ≥95% oxygen to the body leading to augmented oxygen levels in the blood to accelerate improvement of conditions. There has been FDA clearance of approval for specific indications. Most commonly, it is used to treat chronic complex diabetic wounds of the lower limbs. The Plan does not consider medically necessary the topical application of oxygen under any circumstances.

Definitions

• Hyperbaric Oxygen Therapy (HBOT) is a method in which the entire body is exposed to oxygen under increased atmospheric pressure.
• Continuous Topical Oxygen Therapy (CTOT) is a portable unit that can provide continuous flow of atmospheric (normobaric) oxygen to the wound up to 24 hours a day and 7 days a week. This does not require the member to be in-clinic and immobilized for therapy.
• Standard Wound Care in patients with diabetic wounds includes the 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.

Clinical Indications

General Indications

In addition to condition-specific criteria (outlined below), The Plan considers HBOT medically necessary when ALL of the following criteria are met:

1. HBOT must be prescribed and administered by the licensed treating physician; and
2. HBOT must be administered in a chamber (such as the single-patient unit or multiplace unit); and
3. Continued HBOT is limited to 30 day authorization periods unless otherwise noted in the criteria below. Continued HBOT is subject to review for medical necessity and is indicated only when ALL of the following criteria are met:
   1. Adherence to hyperbaric oxygen therapy; and
   2. Evidence of improvement during the authorization period, e.g., reduction in the size of wound and reduction in signs of infection and/or inflammation.

Condition-Specific Indications

The Plan considers HBOT medically necessary when General Indications AND at least one of the following indications are met:

1. Acute air or gas embolism- 1 treatment may be indicated; additional treatments may be indicated only if symptoms persist.
2. Acute carbon monoxide poisoning- 1 to 3 total treatments may be indicated depending on persistence of clinical symptoms.
3. Acute traumatic peripheral ischemia, when there is immediate threat of permanent dysfunction, loss of limb, or death.
4. Anemia, when ALL of the following criteria are met:
   1. Patient unable or unwilling to receive a red blood cell transfusion; and
   2. Emergent treatment, as indicated by 1 or more of the following:
      • Active hemolysis with progressive anemia; or
      • Acute blood loss or active massive hemorrhage; or
      • Hypovolemic shock.
5. Burns (large or severe burns treated at a specialized burn center).
6. Central retinal artery occlusion, when started within 24 hours of symptom onset - Treatment is typically indicated until CRA recanalization has occurred (usually 24-72 hours).
7. Chronic diabetic ulcer, when ALL of the following criteria are met:
   1. Severe wound (Wagner Grade III or higher) based on at least ONE of the following criteria:
      • Deep ulceration to tendon causing tendonitis or non-infected bone; or
      • Deep ulcer with infection (e.g., abscess, osteomyelitis, or joint sepsis); or
      • Localized gangrene (ischemia) of the forefoot or heel.
   2. Prior evaluation and treatment of underlying peripheral vascular and/or neuropathic disease; and
   3. Documented 30-day trial of conventional wound care for diabetes with minimal to no healing and meets ALL of the following:
      • Glycemic optimization; and
      • Wound is not infected or has been treated with antibiotics.
   4. Treatment is indicated daily and meets ALL of the following:
      • Evaluation of the wound occurs at least every 30 days during HBOT and demonstrates measurable signs of healing; and
      • Treatment is ordered for no more than 40 HBOT treatments to allow for review of the evaluation.
8. Compromised skin grafts or flaps, where hypoxia or decreased perfusion has compromised viability acutely when ALL of the following criteria are met:
   1. Correctable causes of the flap failure have been explored and adequately addressed prior to initiation of HBOT.
   2. Treatment is indicated for 2 times per day until the graft or flap appears viable, then 1 time per day until healed.
   3. Efficacy of therapy should be reviewed after 20 treatments and discontinued if no clinical improvement.
9. Crush injuries and compartment syndrome, when there is immediate threat of permanent dysfunction, loss of limb, or death - Treatment is indicated for 7 days or 14 treatment sessions. Treatment typically should occur twice a day for two days, then daily for two days.
10. Carbonmonoxidepoisoning,withorwithoutCyanide poisoning.
11. Decompression illness- Treatment should be rapid and repeated up to 10 times only if symptoms persist.
12. Idiopathic sudden sensorineural hearing loss when ALL of the following_criteria_are_met:
    1. Audiometry showing a 30-dB hearing loss at 3 consecutive frequencies; and
    2. Other underlying potential causes have been ruled out or_aren't_applicable; and
    3. HBOT '}){% endraw %}is given in conjunction with standard of care steroid therapy; and
    4. 15 to 20 total treatments may be indicated once daily only when HBOT is initiated_within_3 months_after_onset.
13. Intracranial abscess when ALL_of_the_following criteria_are_met:
    1. The patient has multiple abscesses, abscesses in_a_deep or_dominate_location,_or_is_immunocompromised ; and
    2. The patient has not responded to or is deteriorating despite standard of care, surgical and/or antibiotic treatment; or is not a candidate for surgery due to high risks or contraindications;
       1. Treatment may be indicated for 1-2 times per day; and
       2. Efficacy of therapy should be reviewed after 20 treatments and discontinued if no clinical improvement.
    3. Necrotizing soft tissue infections and gas gangrene (Clostridial myositis and myonecrosis)
       1. Documentation from a treating physician stating HBOT is used in conjunction with surgical debridement and antibiotics.
       2. Treatment is ordered and indicated for 2 times per day until there is no further extension of necrosis in previously debrided areas.
       3. Efficacy of therapy should be reviewed after 30 treatments and discontinued if no clinical improvement.
    4. Osteomyelitis when ALL of the following criteria are met:
       1. The diagnosis is confirmed by imaging or biopsy; and
       2. Documentation from a treating physician confirms that the patient is unresponsive to conventional medical and surgical management; and the patient has completed at least 6 weeks of appropriate IV antibiotic therapy, and has undergone surgery without resolution or has documented justification for why surgery is not an option.
    5. Radiation injury; up to 40 HBOT treatments are indicated, when ONE of the following criteria are met:
       1. Osteoradionecrosis (e.g., radiation-induced osteonecrosis of the jaw) as an adjunct to conventional treatment; or
       2. Soft tissue radionecrosis as an adjunct to conventional treatment; or
       3. Radiation-induced hemorrhagic cystitis; or
       4. Radiation-induced proctitis; or
       5. Prophylactic prevention of osteonecrosis of the jaw following tooth extraction in an irradiated field:
          • Prior to surgery, treatment is ordered and indicated for 20 HBOT treatments.
          • Immediately after surgery, treatment is ordered and indicated for 10 HBOT treatments.

    Experimental or Investigational / Not Medically Necessary

    Absolute Contraindications for Hyperbaric Oxygen

    • Concurrent administration of the antibiotic cream mafenide (Sulfamylon)
    • Concurrent administration of disulfiram (Antabuse)
    • Concurrent administration of antineoplastic agent doxorubicin
    • Concurrent or past administration of antineoplastic agents bleomycin or cisplatin (Platinol)
    • Premature infants (birth prior to 37 weeks gestation)
    • Untreated pneumothorax

    Experimental or Investigational

    The Plan considers the use of HBOT to be experimental and investigational in the treatment of the following conditions including but not limited to:

    • Actinomycosis
    • Acute cerebral edema
    • Acute coronary syndrome...[and other conditions listed]...
    • Vascular dementia

    Topical Application of Oxygen

    This method of oxygen administration does not meet the definition of HBOT as stated above and there are no high quality evidence-based studies of its use in the literature. In fact, one of the only randomized trials...[remainder of paragraph]...topical oxygen therapy as experimental and investigational. Investigational and experimental treatments are not covered by the Plan. Topical HBOT includes boot or bag systems and single limb or sacral chambers.