Home oxygen therapy is only considered medically necessary if all of the following conditions are met:
Where the above-listed criteria are met, Aetna considers oxygen for home use medically necessary durable medical equipment (DME) in the following circumstances:
Diagnosis of severe lung disease and qualifying lab values:**
Diagnosis of other hypoxia-related symptoms or findings with qualifying lab values:**
Other diagnoses of hypoxia-related symptoms or findings with qualifying lab values** that usually resolve with limited or short-term oxygen therapy:
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.
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:
Oxygen for home use is considered experimental and investigational for indications other than those noted above (e.g., treatment of migraine headaches, treatment of obstructive sleep apnea) because its effectiveness for indications other than the ones listed above has not been established.
**Qualifying laboratory values:
Resting PaO2 of 56 to 59 mm Hg or arterial oxygen saturation of 89 % at rest (awake), during sleep for at least 5 minutes, or during exercise (as described below) in the presence of any of the following
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)
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.
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.
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”).
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.
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 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 and portable oxygen concentrator; or provision of both an oxygen transfilling systems and a portable oxygen system.
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.
Note: Except as noted in short-term indications, reassessment 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 reassessments may be requested at any time at the discretion of Aetna. Reassessments 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.
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.Background
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.
Mehta et al (2013) stated that hypoxemia is an immediate consequence of obstructive sleep apnea (OSA). Oxygen (O2) administration has been used as an alternative treatment in patients with OSA who do not adhere to continuous positive airway pressure (CPAP) in order to reduce the deleterious effects of intermittent hypoxemia during sleep. These researchers investigated the effects of O2 therapy on patients with OSA. They conducted a systematic search of the databases Medline, Embase, Cochrane Central Register of Controlled Trials (1st Quarter 2011), Cochrane Database of Systematic Reviews (from 1950 to February 2011). The search strategy yielded 4,793 citations. Irrelevant papers were excluded by title and abstract review, leaving 105 manuscripts. These investigators reviewed all prospective studies that included: (i) a target population with OSA, (ii) O2 therapy and/or CPAP as a study intervention, (iii) the effects of O2 on the apnea-hypopnea index (AHI), nocturnal hypoxemia, or apnea duration. These researchers identified 14 studies including a total of 359 patients; 9 studies were of single cohort design, while 5 studies were randomized control trials (RCTs) with 3 groups (CPAP, O2, and placebo/sham CPAP). When CPAP was compared to O2 therapy, all but 1 showed a significant improvement in AHI. Ten studies demonstrated that O2 therapy improved oxygen saturation versus placebo. However, the average duration of apnea and hypopnea episodes were longer in patients receiving O2 therapy than those receiving placebo. The authors concluded that the findings of this review showed that O2 therapy significantly improves oxygen saturation in patients with OSA. However, it may also increase the duration of apnea-hypopnea events.
Gottlieb and colleagues (2014) stated that OSA is associated with hypertension, inflammation, and increased cardiovascular risk. Continuous positive airway pressure reduces blood pressure (BP), but adherence is often suboptimal, and the benefit beyond management of conventional risk factors is uncertain. Since intermittent hypoxemia may underlie cardiovascular sequelae of sleep apnea, these researchers evaluated the effects of nocturnal supplemental O2 and CPAP on markers of cardiovascular risk. They conducted a RCT in which patients with cardiovascular disease or multiple cardiovascular risk factors were recruited from cardiology practices. Patients were screened for OSA with the use of the Berlin questionnaire, and home sleep testing was used to establish the diagnosis. Participants with an AHI of 15 to 50 events per hour were randomly assigned to receive education on sleep hygiene and healthy lifestyle alone (the control group) or, in addition to education, either CPAP or nocturnal supplemental O2. Cardiovascular risk was assessed at baseline and after 12 weeks of the study treatment. The primary outcome was 24-hour mean arterial BP. Of 318 patients who underwent randomization, 281 (88 %) could be evaluated for ambulatory BP at both baseline and follow-up. On average, the 24-hour mean arterial BP at 12 weeks was lower in the group receiving CPAP than in the control group (-2.4 mm Hg; 95 % CI: -4.7 to -0.1; p = 0.04) or the group receiving supplemental O2 (-2.8 mm Hg; 95 % CI: -5.1 to -0.5; p = 0.02). There was no significant difference in the 24-hour mean arterial BP between the control group and the group receiving oxygen. A sensitivity analysis performed with the use of multiple imputation approaches to assess the effect of missing data did not change the results of the primary analysis. The authors concluded that in patients with cardiovascular disease or multiple cardiovascular risk factors, the treatment of OSA with CPAP, but not nocturnal supplemental O2, resulted in a significant reduction in BP.
Furthermore, UpToDate reviews on “Management of obstructive sleep apnea in adults” (Kryger and Malhotra, 2014) and “Overview of obstructive sleep apnea in adults” (Strohl, 2014) do not mention oxygen as a therapeutic option.
Documentation, in the form of a prescription written by the physician, must include an estimate of the frequency, duration of use, duration of need, type of system to be used and oxygen flow rate. A physician's statement of recent hospital test results is also acceptable as well as arterial oxygen saturation obtained by pulse oximetry.
International Headache Society Diagnostic Criteria for Cluster Headache:
Aetna uses diagnostic criteria used by the International Headache Society to form a definitive diagnosis of CH. Therefore, the home use of oxygen to treat CH is considered medically necessary by Aetna only when furnished to members who have had at least five severe to very severe unilateral headache attacks lasting 15-180 minutes when untreated. (Intensity of pain: Degree of pain usually expressed in terms of its functional consequence and scored on a verbal 5-point scale: 0=no pain; 1=mild pain, does not interfere with usual activities; 2=moderate pain, inhibits but does not wholly prevent usual activities; 3=severe pain, prevents all activities; 4=very severe pain. It may also be expressed on a visual analogue scale.)
The headaches must be accompanied by at least one of the following findings:
|CPT Codes / HCPCS Codes / ICD-10 Codes|
|Information in the [brackets] below has been added for clarification purposes.  Codes requiring a 7th character are represented by "+":|
|Other CPT codes related to the CPB:|
|82803 - 82810||Gases, blood, any combination of pH, pCO2, pO2, CO2, HCO3 (including calculated O2 saturation); with O2 saturation, by direct measurement, except pulse oximetry; or gases, blood, O2 saturation only, by direct measurement, except pulse oximetry|
|94010 - 94777||Pulmonary medicine|
|99503||Home visit for respiratory therapy care (e.g., bronchodilator, oxygen therapy, respiratory assessment, apnea evaluation)|
|99504||Home visit for mechanical ventilation care|
|HCPCS codes covered if selection criteria are met:|
|E0424||Stationary compressed gaseous oxygen system, rental; includes container, contents, regulator, flowmeter, humidifier, nebulizer, cannula or mask, and tubing|
|E0425||Stationary compressed gas system, purchase; includes regulator, flowmeter, humidifier, nebulizer, cannula or mask, and tubing|
|E0430||Portable gaseous oxygen system, purchase; includes regulator, flowmeter, humidifier, cannula or mask, and tubing|
|E0431||Portable gaseous oxygen system, rental; includes portable container, regulator, flowmeter, humidifier, cannula or mask, and tubing|
|E0433||Portable liquid oxygen system, rental; home liquefier used to fill portable liquid oxygen containers, includes portable containers,regulator, flowmeter, humidifier, cannula or mask and tubing, with or without supply reservoir and content gauge|
|E0434||Portable liquid oxygen system, rental; includes portable container, supply reservoir, humidifier, flowmeter, refill adaptor, contents gauge, cannula or mask, and tubing|
|E0435||Portable liquid oxygen system purchase; includes portable container, supply reservoir, flowmeter, humidifier, contents gauge, cannula or mask, tubing and refill adaptor|
|E0439||Stationary liquid oxygen system, rental; includes container, contents, regulator, flowmeter, humidifier, nebulizer, cannula or mask, and tubing|
|E0440||Stationary liquid oxygen system, purchase; includes use of reservoir, contents indicator, regulator, flowmeter, humidifier, nebulizer, cannula or mask, and tubing|
|E0441||Oxygen contents, gaseous (for use with owned gaseous stationary systems or when both a stationary and portable gaseous system are owned), 1 month's supply = 1 unit|
|E0442||Oxygen contents, liquid (for use with owned liquid stationary systems or when both a stationary and portable liquid system are owned), 1 month's supply = 1 unit|
|E0443||Portable oxygen contents, gaseous (for use only with portable gaseous systems when no stationary gas or liquid system is used), 1 month's supply = 1 unit|
|E0444||Portable oxygen contents, liquid (for use only with portable liquid systems when no stationary gas or liquid system is used), 1 month's supply = 1 unit|
|E1390||Oxygen concentrator, single delivery port, capable of delivering 85 percent or greater oxygen concentration at the prescribed flow rate|
|E1391||Oxygen concentrator, dual delivery port, capable of delivering 85 percent or greater oxygen concentration at the prescribed flow rate, each|
|E1392||Portable oxygen concentrator, rental|
|E1405||Oxygen and water vapor enriching system with heated delivery|
|E1406||Oxygen and water vapor enriching system without heated delivery|
|K0738||Portable gaseous oxygen system, rental; home compressor used to fill portable oxygen cylinders; includes portable containers, regulator, flowmeter, humidifier, cannula or mask, and tubing|
|S8120||Oxygen contents, gaseous, 1 unit equals 1 cubic foot|
|S8121||Oxygen contents, liquid, 1 unit equals 1 pound|
|Other HCPCS codes related to the CPB:|
|A4611||Battery, heavy-duty; replacement for patient-owned ventilator|
|A4612||Battery cables; replacement for patient-owned ventilator|
|A4613||Battery charger; replacement for patient-owned ventilator|
|A4616||Tubing (oxygen), per foot|
|A4620||Variable concentration mask|
|A7046||Water chamber for humidifier, used with positive airway pressure device, replacement, each|
|E0445||Oximeter device for measuring blood oxygen levels non-invasively|
|E0455||Oxygen tent, excluding croup or pediatric tents|
|E0457||Chest shell (cuirass)|
|E0465||Home ventilator, any type, used with invasive interface, (e.g., tracheostomy tube)|
|E0466||Home ventilator, any type, used with non-invasive interface, (e.g., mask, chest shell)|
|E0470||Respiratory assist device, bi-level pressure capability, without backup rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device)|
|E0471||Respiratory assist device, bi-level pressure capability, with back-up rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device)|
|E0472||Respiratory assist device, bi-level pressure capability, with back-up rate feature, used with invasive interface, e.g., tracheostomy tube (intermittent assist device with continuous positive airway pressure device)|
|E0500||IPPB machine, all types, with built-in nebulization; manual or automatic valves; internal or external power source|
|E0550||Humidifier, durable for extensive supplemental humidification during IPPB treatments or oxygen delivery|
|E0555||Humidifier, durable, glass or autoclavable plastic bottle type, for use with regulator or flowmeter|
|E0560||Humidifier, durable for supplemental humidification during IPPB treatment or oxygen delivery|
|E0561||Humidifier, non-heated, used with positive airway pressure device|
|E0562||Humidifier, heated, used with positive airway pressure device|
|E1352||Oxygen accessory, flow regulator capable of positive inspiratory pressure|
|E1354||Oxygen accessory, wheeled cart for portable cylinder or portable concentrator, any type, replacement only, each|
|E1356||Oxygen accessory, battery pack / cartridge for portable concentrator, any type, replacement only, each|
|E1357||Oxygen accessory, battery charger for portable concentrator, any type, replacement only, each|
|E1358||Oxygen accessory, DC power adapter for portable concentrator, any type, replacement only, each|
|ICD-10 codes covered if selection criteria are met (not all-inclusive):|
|A37.01, A37.11, A37.81, A37.91||Pneumonia in whooping cough|
|B44.0||Invasive pulmonary aspergillosis|
|C34.00 - C34.92||Malignant neoplasm of bronchus and lung|
|C78.00 - C78.02||Secondary malignant neoplasm of lung|
|C94.00 - C94.02||Acute erythroid leukemia|
|D02.20 - D02.22||Carcinoma in situ of bronchus and lung|
|D14.30 - D14.32||Benign neoplasm of bronchus and lung|
|D56.0 - D56.9||Thalassemia|
|D57.00 - D57.219
D57.40 - D57.819
|D58.1 - D58.2||Hereditary elliptocytosis and other hemoglobinopathies|
|D75.0 - D75.1||Familial erythrocytosis and secondary polycythemia|
|E84.0 - E84.9||Cystic fibrosis|
|G44.001 - G44.029||Cluster headaches|
|I26.01 - I26.09||Pulmonary embolism with acute cor pulmonale|
|I27.0 - I27.9||Other pulmonary heart diseases|
|I46.2 - I49.9||Cardiac arrest, paroxysmal tachycardia, atrial fibrillation and flutter and other cardiac arrhythmias|
|I50.20 - I50.9||Congestive heart failure|
|J05.0||Acute obstructive laryngitis [croup]|
|J12.0 - J18.1
J18.8 - J18.9
|J40 - J42
J44.0 - J44.9
|Bronchitis and other chronic obstructive pulmonary disease|
|J45.20 - J45.998||Asthma|
|J47.0 - J47.9||Bronchiectasis|
|J84.10||Pulmonary fibrosis, unspecified|
|P27.0 - P27.9||Chronic respiratory diseases originating in the perinatal period|
|P29.3||Persistent fetal circulation|
|R60.0 - R60.9||Edema, not elsewhere classified|
|Z99.81||Dependence on supplemental oxygen|
|ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):|
|G43.001 - G43.919||Migraine|
|G47.33||Obstructive sleep apnea (adult) (pediatric)|
|I20.0 - I20.9||Angina pectoris [in the absence of hypoxemia]|
|I73.81 - I73.9||Other peripheral vascular diseases [resulting in clinically evident desaturation in one or more extremities but in the absence of systemic hypoxemia]|
|R06.00 - R06.09||Dyspnea [without cor pulmonale or evidence of hypoxemia]|