1. Aetna considers oxygen for home use medically necessary durable medical equipment (DME) in the following circumstances:

   1. Diagnosis of severe lung disease and qualifying lab values:**

      • Bronchiectasis
      • Chronic obstructive pulmonary disease (COPD)
      • Cystic fibrosis
      • Diffuse interstitial lung disease
      • Pediatric broncho-pulmonary dysplasia (BPD)
      • Widespread pulmonary neoplasm;
         

   2. Diagnosis of other hypoxia-related symptoms or findings with qualifying lab values:**

      1. Erythrocytosis (hematocrit greater than 55 %)
      2. Pulmonary hypertension
      3. Recurring congestive heart failure due to chronic cor-pulmonale;
          

   3. Other diagnoses of hypoxia-related symptoms or findings with qualifying lab values** that usually resolve with limited or short-term oxygen therapy:

      1. Asthma
      2. Bronchitis
      3. Croup
      4. Pneumonia.

      Although treatment of these diagnoses (pneumonia, asthma, croup, bronchitis) may be considered medically necessary for short-term therapy (generally less than 1 month duration), it is not considered medically necessary on an ongoing basis absent special circumstances.  Requests for more than episodic oxygen for these diagnoses are subject to medical review.  For ongoing oxygen treatment, repeat qualifying lab values are reviewed on a monthly basis.

   4. Other diagnoses for which short-term use of oxygen has been shown to be beneficial (unrelated to hypoxia), e.g., cluster headaches may be certified as medically necessary on an individual case basis upon medical review:

      1. Cluster headaches
      2. Hemoglobinopathies.  Self-administration of adjunctive short-term oxygen therapy in the outpatient setting has been shown to be beneficial and reduce hospitalizations in individuals with hemoglobinopathies, such as hemoglobin sickle cell disease, during vaso-occlusive crisis exacerbated by hypoxia
      3. Infants with BPD may have variable oxygen needs, thus, consideration on a case-by-case basis may be required in the absence of documentation of otherwise qualifying oxygen saturation values. 

      Oxygen for home use is considered experimental and investigational for indications other than those noted above (e.g., migraine headaches) because its effectiveness for indications other than the ones listed above has not been established.

      **Qualifying laboratory values:

      Continuous Oxygen:

      1. Resting PaO₂ less than or equal to 55 mm Hg or oxygen saturation less than or equal to 88 %

      2. Resting PaO₂ of 56 to 59 mm Hg or oxygen saturation of 89 % in the presence of any of the following

         1. Dependent edema suggesting congestive heart failure
         2. Erythrocythemia (hematocrit greater than 56 %)
         3. P pulmonale on the electrocardiogram (P wave greater than 3 mm in standard leads II, III, or aVF)
             

      3. Resting PaO₂ greater than 59 mm Hg or oxygen saturation greater than 89 % only with additional documentation justifying the oxygen prescription and a summary of more conservative therapy that has failed.

      Non-continuous Oxygen: (oxygen flow rate and number of hours per day must be specified)

      1. During exercise: PaO₂ less than or equal to 55 mm Hg or oxygen saturation less than or equal to 88 % with a low level of exertion

      2. During sleep: PaO₂ less than or equal to 55 mm Hg or oxygen saturation less than or equal to 88 % with associated complications, such as pulmonary hypertension, daytime somnolence, and cardiac arrhythmias.

   Note: All qualification studies must be done while on room air unless medically contraindicated.  Documentation of blood gas values can come from the doctor's office, hospital or from an outpatient laboratory.

2. Oxygen Delivery Systems

   The following delivery systems may be considered medically necessary:

   Stationary: Oxygen concentrators, liquid reservoirs, or large cylinders (usually K or H size) that are designed for stationary use.

   1. Considered medically necessary for members who do not regularly go beyond the limits of a stationary oxygen delivery system with a 50-ft tubing or those who use oxygen only during sleep.

   Portable: Systems that weigh 10 lbs or more and are designed to be transported but not easily carried by the member, e.g., a steel cylinder attached to wheels (“stroller”).

   1. Considered medically necessary for members who occasionally go beyond the limits of a stationary oxygen delivery system with 50-ft tubing for less than 2  hours per day for most days of the week (minimum 2 hours/week).

   Ambulatory: Systems that weigh less than 10 lbs when filled with oxygen, are designed to be carried by the member, and will last for 4 hours at a flow equivalent to 2 L/min continuous flow; e.g., liquid refillable units and aluminum or fiber wrapped light-weight cylinders, with or without oxygen conserving devices.

   1. Considered medically necessary for members who regularly go beyond the limits of a stationary oxygen delivery system with a 50-ft tubing for 2 hours or more per day and for most days of the week (minimum 6 hours/week).

   2. Prescription based on the activity status of the member, the appropriate oxygen delivery system will be delivered.

   Portable Oxygen Concentrators: Portable oxygen concentrators and combination stationary/portable oxygen systems are considered medically necessary as an alternative to ambulatory oxygen systems for members who meet both of the following criteria:

   • Member meets criteria for ambulatory oxygen systems (see above); and

   • Member is regularly (at least monthly) away from home for durations that exceed the capacity of ambulatory oxygen systems.

   A second oxygen tank (spare tank) is considered not medically necessary, except in instances where the member is dependent on continuous oxygen.  A single oxygen tank may be considered medically necessary for a person who is dependent on an oxygen concentrator.
   
   Emergency or standby oxygen systems are considered not medically necessary.

   Duplicate oxygen systems are considered convenience items and not medically necessary, including but not limited to: provision of both a stationary (E1390) and portable (E1392) oxygen concentrator; or provision of both an oxygen transfilling systems and a portable oxygen system (e.g., E0433 with E0434; and, K0738 with E0431).
   
   Notes: Electrical generators do not meet Aetna's definition of DME because they are not primarily medical in nature. 
   
   Humidifiers (e.g., Vapotherm) for oxygen nasal cannula are not separately reimbursable.
   
   Rental versus purchase: Aetna considers the rental or, if less costly, purchase of oxygen equipment medically necessary when selection criteria are met.
   
   The reasonable useful lifetime for oxygen equipment is 5 years. The RUL is not based on the chronological age of the equipment. It starts on the initial date of service and runs for 5 years from that date.

   Ambulatory oxygen systems and portable oxygen concentrators are considered not medically necessary for members who qualify for oxygen solely based on blood gas studies obtained during sleep.

3. Re-assessment

   Note: Except as noted in short-term cases (see 1C above), re-assessment of oxygen needs through pulse oximetry or arterial blood gas is required and must be performed by an independent respiratory provider at 12 months after the initiation of therapy for persons who qualify for oxygen based upon an arterial PO2 at or below 55 mm Hg or an arterial oxygen saturation at or below 88 %, or at 3 months after initiation for persons who qualify for oxygen based upon an arterial PO2 between 56 to 59 mm Hg or an arterial oxygen saturation of 89 % with dependent edema, P pulmonale, or erythrocythemia.  Additional re-assessments may be requested at any time at the discretion of Aetna.  Re-assessments must be done by an Aetna participating oxygen-qualifying company that is in no way connected to the company supplying the oxygen therapy (as per Medicare guidelines).  The member's primary care and/or treating doctor must be notified for authorization of all testing and treatment changes, including the discontinuation of coverage for oxygen therapy.

4. Aetna considers rental of airline oxygen tank medically necessary when members meet the criteria for oxygen for home use listed above and they are not allowed to use their own portable oxygen tank on the plane.

Note: This policy applies to all products with coverage for DME.  Under plans that do not cover DME, domiciliary oxygen may be covered on a case-by-case basis subject to medical review to avert hospital confinement.

See CPB 0339 - Pulse Oximetry for Home Use for the use of pulse oximetry in periodically re-assessing the need for long-term oxygen in the home.

This policy is supported by criteria from the Centers for Medicare & Medicaid Services (CMS).

In a Cochrane review, Bennett et al (2008) evaluated the safety and effectiveness of hyperbaric oxygen therapy (HBOT) and normobaric oxygen therapy (NBOT) for treating and preventing migraine and cluster headaches.  These investigators searched the following in May 2008: CENTRAL, MEDLINE, EMBASE, CINAHL, DORCTIHM and reference lists from relevant articles.  Relevant journals were hand-searched and researchers contacted.  Randomized trials comparing HBOT or NBOT with one another, other active therapies, placebo (sham) interventions or no treatment in patients with migraine or cluster headache were selected for analysis.  Three reviewers independently evaluated study quality and extracted data.  A total of 9 small trials involving 201 participants were included; 5 trials compared HBOT versus sham therapy for acute migraine, 2 compared HBOT to sham therapy for cluster headache and 2 evaluated NBOT for cluster headache.  Pooling of data from 3 trials suggested that HBOT was effective in relieving migraine headaches compared to sham therapy (relative risk (RR) 5.97, 95 % confidence interval (CI): 1.46 to 24.38, p = 0.01).  There was no evidence that HBOT could prevent migraine episodes, reduce the incidence of nausea and vomiting or reduce the requirement for rescue medication.  There was a trend to better outcome in a single trial evaluating HBOT for the termination of cluster headache (RR 11.38, 95 % CI: 0.77 to 167.85, p = 0.08), but this trial had low power.  NBOT was effective in terminating cluster headache compared to sham in a single small study (RR 7.88, 95 % CI: 1.13 to 54.66, p = 0.04), but not superior to ergotamine administration in another small trial (RR 1.17, 95 % CI: 0.94 to 1.46, p = 0.16).  Seventy-six per cent of patients responded to NBOT in these 2 trials.  No serious adverse effects of HBOT or NBOT were reported.  The authors concluded that there was some evidence that HBOT was effective for the termination of acute migraine in an unselected population, and weak evidence that NBOT was similarly effective in cluster headache.  Given the cost and poor availability of HBOT, more research should be done on patients unresponsive to standard therapy.  NBOT is cheap, safe and easy to apply, so will probably continue to be used despite the limited evidence in this review.

The National Institute for Health and Clinical Excellence (NICE)’s guideline on “Diagnosis and management of headaches in young people and adults” (2012) recommended oxygen therapy for cluster headaches; but did not mention its use for migraines.

Jurgens et al (2013) noted that while inhalation of high-flow 100 % oxygen is highly effective in cluster headache, studies on its efficacy in migraine are sparse and controversial.  These researchers reported the case of a 22-year old patient with an 8-year history of strictly unilateral migraine without aura but cranial autonomic symptoms.  She repeatedly responded completely to inhalation of high-flow pure oxygen within 15 mins but suffered from recurrence of attacks within 30 mins after discontinuation.  The authors concluded that in line with experimental animal studies, this case suggested a clinically relevant efficacy of inhaled oxygen in patients with migraine with accompanying cranial autonomic symptoms.

Furthermore, UpToDate reviews on “Acute treatment of migraine in adults” (Bajwa and Sabahat, 2013a) and “Preventive treatment of migraine in adults” (Bajwa and Sabahat, 2013b) do not mention the use of oxygen as a management tool.