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Medical Policy

Policy Num:       02.001.042
Policy Name:    Home Oxygen Therapy
Policy ID:          [02.001.042]  [Ar / L / M+ / P+ ]  [0.00.00]

Last Review:      August 22, 2023
Next Review:      Policy Archived
 

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Related Policies: None

HOME OXYGEN THERAPY

Summary

Home oxygen therapy is used to treat and prevent symptoms and manifestations of hypoxemia.  Home oxygen therapy can be indicated in severe pulmonary diseases like chronic obstructive pulmonary disease (COPD), diffuse interstitial lung disease, cystic fibrosis, bronchiectasis or lung cancer. Oxygen therapy can also be indicated in conditions with hypoxia symptoms like pulmonary hypertension, erythrocytosis, recurring heart failure due to chronic cor pulmonale. Short term therapy can be indicated in pneumonia, asthma, bronchitis or bronchiolitis. Hypoxemia needs to be demonstrated with an arterial blood gas (ABG) test. 

This test should be done at room air unless medically contraindicated. Oxygen therapy frequency, flow and duration needs to be prescribed by a physician when starting therapy. Therapy long term necessity needs to be evaluated with pulse oximetry every three months, each time an increase in oxygen is required or when equipment type change is needed.

Objective

Oxygen and oxygen supplies are considered medically necessary for appropriately selected patients only in cases when oxygen is prescribed by a physician, and the prescription must specify: (1) a diagnosis of the disease requiring use of oxygen; (2) oxygen concentration and flow rate; (3) frequency of use (if an intermittent or leave in oxygen therapy, order must include time limits and specific indications for initiating and terminating therapy); (4) method of delivery; and (5) duration of use (if the oxygen is prescribed on an indefinite basis, care must be periodically reviewed to determine whether a medical need continues to exist).

Policy Statements

Stationary oxygen equipment and home oxygen therapy are covered for payment when the following criteria is met:

·         At least one of the following diagnosis:

o    Chronic obstructive pulmonary disease

o    Cystic Fibrosis

o    Bronchiectasis

o    Lung Cancer

o    Pulmonary hypertension

o    Erythrocytosis

o    Pneumonia

o    Asthma

o    Bronchitis

o    Bronchiolitis

o    Recurring congestive heart failure due to cor pulmonale

·         For cluster headache diagnosis when other therapies have failed.

·         Hypoxemia evidence by any combination of the following clinical findings and oxygenation results (taken at room air unless medically contraindicated):

o    PO₂ ≤ 55 mm Hg or arterial oxygen saturation ≤ 88% at rest.

o    PO₂ ≤ 55 mm Hg or arterial oxygen saturation ≤ 88% for at least 5 minutes taken during sleep for a person with a PO₂ ≥ 56 mm Hg or arterial oxygen saturation ≥ 89% awake.

o    A decrease of more than 10 mm Hg in arterial PO₂, or a reduction in arterial oxygen saturation for more than 5% for at least 5 minutes of sleep

o    Decrease in arterial PO2 of more than 10 mm Hg or a decrease in arterial oxygen saturation more than 5% for at least 5 minutes taken during sleep associated with symptoms or signs attributable to hypoxemia including, but not limited to, cor pulmonale, “P” pulmonale on electrocardiogram [EKG], pulmonary hypertension, and erythrocytosis.

o    Arterial PO₂ ≤ 55-59 mm Hg or or arterial oxygen saturation ≤ 89% at rest, for at least 5 minutes during sleep or during exercise (as described in the first bullet) and one of the following:

§  Dependent edema associated with congestive heart failure

§  Pulmonary hypertension, chronic cor pulmonale or congestive heart failure with hypoxemia

§  Erythrocythemia with a hematocrit greater than 56%

Portable oxygen systems are covered for payment when criteria for stationary oxygen necessity is met and the patient is mobile within the home.

Portable oxygen concentrators and combinations of stationary/portable oxygen systems are covered for payment when the above criteria are met, and the

patient is active and frequently exceeds the time limitations in conventional ambulatory oxygen systems.

Policy Guidelines

Oxygen therapy is considered medically necessary for:

1. Severe lung disease, defined as either: a resting arterial oxygen partial pressure (Pa02) below 55mm Hg; or an O2 saturation less than 90%; or symptoms associated with oxygen deprivation,such as impairment of cognitive processes, restlessness, or insomnia. Examples of severe lungdisease include, but are not limited to:

·         Chronic obstructive pulmonary disease (COPD);

·         Pulmonary fibrosis;

·         Cystic fibrosis;

·         Bronchiectasis;

·         Recurring congestive heart failure due to chronic cor pulmonale;

·         Chronic lung disease complicated by erythrocytosis (hematocrit >56%).

2. Cluster headaches when other treatment fails.

Oxygen therapy is considered not medically necessary for the following conditions:

·         Angina pectoris in the absence of hypoxemia;

·         Breathlessness without evidence of hypoxemia;

·         Severe peripheral vascular disease resulting in clinically evident desaturation in one or more

·         extremities;

·         Terminal illnesses that do not affect the lungs.

Portable oxygen systems are considered medically necessary only if the patient ambulates on a regular

basis.

Benefit Application

BlueCard/National Account Issues

Claims for oxygen therapy are supported by documentation of severe hypoxemia defined as PO2 less than 55 mm Hg or oxygen saturation of less than 85%. Patients receiving long-term oxygen therapy should be periodically re-evaluated to assess whether hypoxemia persists. The following components of oxygen therapy are considered not medically necessary and thus are ineligible for coverage:

• Oxygen and oxygen supplies in facilities that are expected to supply such items;
• Setup or installation of respiratory support systems;
• Preset regulators used with portable oxygen systems;
• Regulators that permit a flow rate greater than 8 liters per minute, as these units are not

• appropriate for home use;
• An excessive number of spare tanks, as they are considered a convenience item only;
• A prescription for oxygen for use as needed (PRN).

The rental of oxygen tanks is eligible for coverage subject to the Durable Medical Equipment Benefit in the contract or certificate of coverage.

“E” tanks normally do not qualify as a portable oxygen system; however, there may be instances when an

“E” tank may be considered medically necessary even though the patient has a stationary tank at bedside. This should be reviewed on an individual basis.

Charges for oxygen carts, racks, or stands are included in the suppliers’ fee for use of the oxygen tank and are not eligible for coverage as a separate service.

If more than one tank is required in a month, the cost of the oxygen contained in two or more tanks will be covered. Rental will be paid for the initial tank only.

Routine oxygen supplies include the following:

• Portable oxygen systems;
• Mask or nasal cannula
• Maxi-mist;
• Nebulizer;
• Oxygen gauge;
• Oxygen humidifier;

Oxygen tubing.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.
 

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.

1.         a target population with OSA,

2.         O2 therapy and/or CPAP as a study intervention,

3.         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.

Acute Myocardial Infarction Fu and colleagues (2017) stated that potential benefits or risks of oxygen inhalation for patients with acute myocardial infarction (MI) are not fully understood. 

In a systematic review and meta-analysis, these researchers evaluated the safety and effectiveness of oxygen therapy for patients with acute MI.  They searched RCTs systematically in PubMed, Embase, Web of Science and Cochrane Library up to June 2016; RCTs that estimated the safety and effectiveness of oxygen therapy for patients with acute MI were identified by 2 independent reviewers.  The primary outcomes were short-term mortality and recurrent rate of MI, and the secondary outcomes were arrhythmia incidence and pain incidence; RRs and 95 % CIs were used to measure the pooled data.  A total of 5 RCTs were in accordance with inclusion criteria and were included in this meta-analysis.  Compared with no oxygen group, the oxygen group did not significantly reduce short-term death (RR: 1.08, 95 % CI: 0.31 to 3.74), and there was moderate heterogeneity (I2 = 50.8 %, p < 0.107) among studies. 

These investigators found a significant increase in the rate of recurrent MI (RR: 6.73, 95 % CI: 1.80 to 25.17, I2 = 0.0 %, p = 0.598) in the oxygen group.  The oxygen group did not have a significant reduction in arrhythmia (RR: 1.12, 95 % CI: 0.91 to 1.36; I2 = 46.2 %, p < 0.156) or pain (RR: 0.97, 95 % CI: 0.91 to 1.04; I2 = 7.2 %, p = 0.340).  The authors concluded that oxygen inhalation did not benefit patients with acute MI with normal oxygen saturation; and it may increase the rate of recurrent MI.  They stated that high quality trials with larger sample sizes are needed.

Hofmann and associates (2017) noted that the clinical effect of routine oxygen therapy in patients with suspected acute MI who do not have hypoxemia at baseline is uncertain.  In this registry-based randomized clinical trial, these researchers used nationwide Swedish registries for patient enrollment and data collection.  Patients with suspected MI and an oxygen saturation of 90 % or higher were randomly assigned to receive either supplemental oxygen (6 L/min for 6 to 12 hours, delivered through an open face mask) or ambient air.  A total of 6,629 patients were enrolled.  The median duration of oxygen therapy was 11.6 hours, and the median oxygen saturation at the end of the treatment period was 99 % among patients assigned to oxygen and 97 % among patients assigned to ambient air.  Hypoxemia developed in 62 patients (1.9 %) in the oxygen group, as compared with 254 patients (7.7 %) in the ambient-air group. 

The median of the highest troponin level during hospitalization was 946.5 ng/Lin the oxygen group and 983.0 ng/L in the ambient-air group.  The primary end-point of death from any cause within 1 year after randomization occurred in 5.0 % of patients (166 of 3,311) assigned to oxygen and in 5.1 % of patients (168 of 3,318) assigned to ambient air (hazard ratio [HR], 0.97; 95 % CI: 0.79 to 1.21; p = 0.80).  Re-hospitalization with MI within 1 year occurred in 126 patients (3.8 %) assigned to oxygen and in 111 patients (3.3 %) assigned to ambient air (HR, 1.13; 95 % CI: 0.88 to 1.46; p = 0.33).  The results were consistent across all pre-defined subgroups.  The authors concluded that routine use of supplemental oxygen in patients with suspected MI who did not have hypoxemia was not found to reduce 1-year all-cause mortality.

Acute Respiratory Failure in Immunocompromised Individuals Huang and colleagues (2017) evaluated the effect of high-flow nasal cannula oxygen therapy (HFNC) compared with other oxygen technique for the treatment of acute respiratory failure in immunocompromised individuals.  These investigators searched Cochrane library, Embase, PubMed databases before August 15, 2017 for eligible articles.  A meta-analysis was performed for measuring short-term mortality (defined as intensive care unit [ICU], hospital or 28-days mortality) and intubation rate as the primary outcomes, and length of stay (LOS) in ICU as the secondary outcome.  They included 7 studies involving 667 patients.  Use of HFNC was significantly associated with a reduction in short-term mortality (RR 0.66; 95 % CI: 0.52 to 0.84, p = 0.0007) and intubation rate (RR 0.76, 95 % CI: 0.64 to 0.90; p = 0.002).  In addition, HFNC did not significantly increase LOS in ICU (MD 0.15 days; 95 % CI: -2.08 to 2.39; p = 0.89).  The authors concluded that the findings of the current meta-analysis suggested that the use of HFNC significantly improved outcomes of acute respiratory failure in immunocompromised patients.  However, due to the quality of the included studies, further adequately powered RCTs are needed to confirm these findings.

In a Cochrane review, Corley and associates (2017) the safety and effectiveness of HFNC compared with comparator interventions in terms of treatment failure, mortality, adverse events (AEs), duration of respiratory support, hospital and ICU-LOS, respiratory effects, patient-reported outcomes, and costs of treatment.  These investigators searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 3), Medline, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Embase, Web of Science, proceedings from four conferences, and clinical trials registries; and they hand-searched reference lists of relevant studies.  They conducted searches from January 2000 to March 2016 and re-ran the searches in December 2016.  They added 4 new studies of potential interest to a list of “Studies awaiting classification” and incorporated them into formal review findings during the review update.  These researchers included randomized controlled studies with a parallel or cross-over design comparing HFNC use in adult ICU patients versus other forms of non-invasive respiratory support (low-flow oxygen via nasal cannulae or mask, CPAP, and bi-level positive airway pressure (BiPAP)).  Two review authors independently assessed studies for inclusion, extracted data, and assessed risk of bias.  They included 11 studies with 1,972 participants.  Participants in 6 studies had respiratory failure, and in 5 studies required oxygen therapy after extubation; 10 studies compared HFNC versus low-flow oxygen devices; 1 of these also compared HFNC versus CPAP, and another compared HFNC versus BiPAP alone.  Most studies reported randomization and allocation concealment inadequately and provided inconsistent details of outcome assessor blinding.  These researchers did not combine data for CPAP and BiPAP comparisons with data for low-flow oxygen devices; study data were insufficient for separate analysis of CPAP and BiPAP for most outcomes.  For the primary outcomes of treatment failure (1,066 participants; 6 studies) and mortality (755 participants; 3 studies), investigators found no differences between HFNC and low-flow oxygen therapies (RR, Mantel-Haenszel (MH), random-effects 0.79, 95 % CI: 0.49 to 1.27; and RR, MH, random-effects 0.63, 95 % CI: 0.38 to 1.06, respectively).  These investigators used the GRADE approach to downgrade the certainty of this evidence to low because of study risks of bias and different participant indications.  Reported AEs included nosocomial pneumonia, oxygen desaturation, visits to general practitioner for respiratory complications, pneumothorax, acute pseudo-obstruction, cardiac dysrhythmia, septic shock, and cardiorespiratory arrest.  However, single studies reported AEs, and the authors could not combine these findings; 1 study reported fewer episodes of oxygen desaturation with HFNC but no differences in all other reported AEs. 

These researchers down-graded the certainty of evidence for AEs to low because of limited data.  Researchers noted no differences in ICU-LOS(mean difference (MD), inverse variance (IV), random-effects 0.15, 95 % CI: -0.03 to 0.34; 4 studies; 770 participants), and they down-graded quality to low because of study risks of bias and different participant indications.  They found no differences in oxygenation variables: partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) (MD, IV, random-effects 7.31, 95 % CI: -23.69 to 41.31; 4 studies; 510 participants); PaO2 (MD, IV, random-effects 2.79, 95 % CI: -5.47 to 11.05; 3 studies; 355 participants); and oxygen saturation (SpO2) up to 24 hours (MD, IV, random-effects 0.72, 95 % CI: -0.73 to 2.17; 4 studies; 512 participants).  Data from 2 studies showed that oxygen saturation measured after 24 hours was improved among those treated with HFNC (MD, IV, random-effects 1.28, 95 % CI: 0.02 to 2.55; 445 participants), but this difference was small and was not clinically significant.  Along with concern about risks of bias and differences in participant indications, review authors noted a high level of unexplained statistical heterogeneity in oxygenation effect estimates, and treated with HFNC (MD, IV, random-effects -0.75, 95 % CI: -2.04 to 0.55; 3 studies; 590 participants); 2 studies reported no differences in atelectasis; the authors did not combine these findings.  Data from 6 studies (867 participants) comparing HFNC versus low-flow oxygen showed no differences in respiratory rates up to 24 hours according to type of oxygen delivery device (MD, IV, random-effects -1.51, 95 % CI: -3.36 to 0.35), and no difference after 24 hours (MD, IV, random-effects -2.71, 95 % CI: -7.12 to 1.70; 2 studies; 445 participants).  Improvement in respiratory rates when HFNC was compared with CPAP or BiPAP was not clinically important (MD, IV, random-effects -0.89, 95 % CI: -1.74 to -0.05; 2 studies; 834 participants).  Results showed no differences in patient-reported measures of comfort according to oxygen delivery devices in the short-term (MD, IV, random-effects 0.14, 95 % CI: -0.65 to 0.93; 3 studies; 462 participants) and in the long-term (MD, IV, random-effects -0.36, 95 % CI: -3.70 to 2.98; 2 studies; 445 participants); these researchers down-graded the certainty of this evidence to low; 6 studies measured dyspnea on incomparable scales, yielding inconsistent study data.  No study in this review provided data on positive end-expiratory pressure (PEEP) measured at the pharyngeal level, work of breathing, or cost comparisons of treatment.  The authors were unable to demonstrate whether HFNC was a more safe or effective oxygen delivery device compared with other oxygenation devices in adult ICU patients.  Meta-analysis could be performed for few studies for each outcome, and data for comparisons with CPAP or BiPAP were very limited.  In addition, they identified some risks of bias among included studies, differences in patient groups, and high levels of statistical heterogeneity for some outcomes, leading to uncertainty regarding the results of this analysis.  Thus, they stated that evidence is insufficient to show whether HFNC provided safe and effective respiratory support for adult ICU patients.

Acute Stroke

In a single-blind, randomized clinical trial, Roffe and colleagues (2017) examined if routine prophylactic low-dose oxygen therapy was more effective than control oxygen administration in reducing death and disability at 90 days, and if so, whether oxygen given at night only, when hypoxia is most frequent, and oxygen administration is least likely to interfere with rehabilitation, was more effective than continuous supplementation.  A total of 8,003 adults with acute stroke were enrolled from 136 participating centers in the United Kingdom within 24 hours of hospital admission if they had no clear indications for or contraindications to oxygen treatment (1st patient enrolled April 24, 2008; last follow-up January 27, 2015).  Participants were randomized 1:1:1 to continuous oxygen for 72 hours (n = 2,668), nocturnal oxygen (21:00 to 07:00 hours) for 3 nights (n = 2,667), or control (oxygen only if clinically indicated; n = 2,668). 

Oxygen was given via nasal tubes at 3 L/min if baseline oxygen saturation was 93 % or less and at 2 L/min if oxygen saturation was greater than 93 %.  The primary outcome was reported using the modified Rankin Scale (mRS) score (disability range, 0 [no symptoms] to 6 [death]; minimum clinically important difference, 1 point), assessed at 90 days by postal questionnaire (participant aware, assessor blinded).  The mRS score was analyzed by ordinal logistic regression, which yielded a common odds ratio (OR) for a change from 1 disability level to the next better (lower) level; or greater than 1.00 indicates improvement.  A total of 8,003 patients (4,398 (55 %) men; mean [SD] age of 72 [13] years; median National Institutes of Health Stroke Scale (NIHSS) score of 5; mean baseline oxygen saturation, 96.6 %) were enrolled.  The primary outcome was available for 7,677 (96 %) participants.  The unadjusted OR for a better outcome (calculated via ordinal logistic regression) was 0.97 (95 % CI: 0.89 to 1.05; p = 0.47) for oxygen versus control, and the OR was 1.03 (95 % CI: 0.93 to 1.13; p = 0.61) for continuous versus nocturnal oxygen.  No subgroup could be identified that benefited from oxygen.  At least 1 serious adverse event (AE) occurred in 348 (13.0 %) participants in the continuous oxygen group, 294 (11.0 %) in the nocturnal group, and 322 (12.1 %) in the control group.  No significant harms were identified.  The authors concluded that among non-hypoxic patients with acute stroke, the prophylactic use of low-dose oxygen supplementation did not reduce death or disability at 3 months.  They stated that these findings did not support low-dose oxygen in this setting.

Reduction of Transfusion-Related Adverse Events in Pregnant Women with Sickle Cell Disease Ribeil and colleagues (2018) noted that sickle cell disease (SCD) in pregnancy can be associated with adverse maternal and perinatal outcomes.  Furthermore, complications of SCD can be aggravated by pregnancy.  Optimal prenatal care aims to decrease the occurrence of maternal and fetal complications.  In a retrospective, French, 2-center study, these investigators compared 2 care strategies for pregnant women with SCD over 2 time-periods.  In the 1st study period (2005 to 2010), women were systematically offered prophylactic transfusions.  In the 2nd study period (2011 to 2014), a targeted transfusion strategy was applied whenever possible, and home-based prophylactic nocturnal oxygen therapy was offered to all the pregnant women.  The 2 periods did not differ significantly in terms of the incidence of vaso-occlusive events.  Maternal mortality, perinatal mortality, and obstetric complication rates were also similar in the 2 periods, as was the incidence of post-transfusion complications (6.1 % in 2005 to 2010 and 1.3 % in 2011 to 2014, p = 0.15), although no de-novo allo-immunizations or delayed hemolysis transfusion reactions were observed in the 2nd period.  The authors concluded that the findings of this preliminary, retrospective study indicated that targeted transfusion plus home-based prophylactic nocturnal oxygen therapy was safe and may decrease transfusion requirements and transfusion-associated complications.  They stated that the use of prophylactic home oxygen therapy in SCD appeared promising as their patients currently request this new therapeutic option (despite its constraints); the preliminary results in previous studies have been positive; and a pilot study of morbidity prevention in SCD by overnight supplementary oxygen has recently been initiated.  These researchers stated that their forthcoming prospective multi-center RCT should enable them to establish a severity score and therefore adapt the therapeutic strategy according to a patient's risk factors.

The authors stated that no definitive conclusion could be drawn from this retrospective study of 2 concomitant changes in their treatment strategy (i.e., targeted transfusion and prophylactic oxygen therapy).  The methodological drawback of retrospective studies was highlighted in a recent meta‐analysis by Malinowski et al.  Considering this limitation, these researchers have set up a prospective, multi-center RCT of prophylactic oxygen therapy during SCD pregnancies.  In fact, these investigators hypothesize that prophylactic oxygen therapy relieves the symptoms of SCD (particularly during pregnancy).  Accordingly, they intend to examine if an independent effect on treatment outcomes exists in this high‐risk medical setting.  The study will investigate whether prophylactic oxygen therapy will decrease the transfusion requirement and the incidence of severe post‐transfusion complications without increasing the incidence of vaso‐occlusive crises or obstetric complications.  If this end-point is met, prophylactic oxygen therapy may be of major value, especially in regions with sub‐optimal transfusion safety.  All the pregnant women with SCD in this ongoing RCT will undergo oximetry measurements for 2 consecutive nights so that these researchers can establish whether the results are significant in a hypoxic subgroup only.

Treatment of Pediatric Seizures There are a lack of published clinical studies of the effectiveness of home oxygen as a treatment for epilepsy in children. UpToDate reviews on “Seizures and epilepsy in children: Initial treatment and monitoring” (Wilfong, 2018a) and “Seizures and epilepsy in children: Refractory seizures and prognosis” (Wilfong, 2018b) do not mention oxygen as a therapeutic option.

Regulatory Status

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=9750&p_table=STANDARDS

Rationale

A search of literature was completed through the MEDLINE database from January 1990 through September 1996. The search strategy focused on references containing the following Medical Subject

Heading:

– Oxygen

Research was limited to English-language journals on humans.

See also:

Medicare Guidelines on Oxygen

Population Reference No. 1 

Individuals with COPD, Bronchiectasis, emphysema etc. Interventions of interest home oxygen therapy. Comparators of interest are no home oxygen therapy. Relevant outcomes include overall survival, symptoms and functional outcomes.

Population Reference No. 2 

Individuals with recurring congestive heart failure due to cor pulmonal. Interventions of interest home oxygen therapy. Comparators of interest are no home oxygen therapy. Relevant outcomes include overall survival, symptoms and functional outcomes.

Population Reference No. 3

Individuals with chronic lung disease (diffuse interstitial lung disease, pulmonary or cystic fibrosis lung cancer) and hypoxia symptoms, e.g. erythrocytosis, pulmonary hypertension. Interventions of interest home oxygen therapy. Comparators of interest are no home oxygen therapy. Relevant outcomes include overall survival, symptoms and functional outcomes.

Population Reference No. 4 

Individuals with short term need of O2, e.g. pneumonia, asthma, bronchitis, bronchiolitis. Interventions of interest home oxygen therapy. Comparators of interest are no home oxygen therapy. Relevant outcomes include overall survival, symptoms and functional outcomes

Population Reference No. 5 

Individuals with Cluster headaches when other treatment fails. Interventions of interest home oxygen therapy. Comparators of interest are no home oxygen therapy. Relevant outcomes include overall survival, symptoms and functional outcomes

Supplemental Information

Coverage Criteria Medicare coverage of home oxygen and oxygen equipment under the durable medical equipment (DME) benefit is considered reasonable and necessary only for patients with significant hypoxemia who meet the Medicare coverage criteria. For coverage criteria, see the NCD for Home Use of Oxygen (240.2). Also see the DME MAC LCD for Oxygen and Oxygen Equipment (L33797). (Accessed January 17, 2019) For other oxygen related equipment and supplies, see the Coverage Summary of Durable Medical Equipment (DME), Prosthetics, Corrective Appliances/Orthotics (Non-Foot Orthotics) and Medical Supplies Grid

Practice Guidelines and Position Statements

N/A

Medicare National Coverage

N/A

References

1.     American Association for Respiratory Care (AARC) Clinical Practice Guideline. Pulmonary Rehabilitation. Respir Care 2002; 47(5):617-625. Accessed at: http://www.rcjournal.com/online_resources/cpgs/prcpg.html  

2.     American Association for Respiratory Care (AARC) Clinical Practice Guideline. Discharge Planning for the Respiratory Care Patient. Respir Care 1995;40(12):1308-1312. Accessed at: http://www.rcjournal.com/online_resources/cpgs/dprpcpg.html

3.     Centers for Medicare and Medicaid Services. NCD for home Use of Oxygen (240.2). October 1993. Available at: http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=240.2&ncd_version=1&basket=ncd%3A240%2E2%3A1%3AHome+Use+of+Oxygen

4.     Centers for Medicare and Medicaid Services. LCD for Oxygen and Oxygen Equipment (L11457). Effective, Oct. 1993, revised Jan 2010. Available at: http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=11457&lcd_version=51&show=all

5.     Strickland SL, Hogan TM, Hogan RG, et al. A randomized multi-arm repeated-measures prospective study of several modalities of portable oxygen delivery during assessment of functional exercise capacity. Respir Care. 2009 Mar;54(3):344-9.

6.     American Association for Respiratory Care (AARC). AARC clinical practice guideline. Oxygen therapy in the home or alternate site health care facility--2007 revision & update. Respir Care. 2007 Aug;52(8):1063-8.

7.     American Association for Respiratory Care (AARC) Clinical Practice Guideline. Selection of an oxygen delivery device for neonatal and pediatric patients: 2002 revision and update. Respir Care. 2002;47 (6):707-716.

8.     American Thoracic Society. Management of stable COPD: long-term oxygen therapy. 2004. Accessed September 6, 2011. Available at URL address: http://www.thoracic.org/clinical/copd-guidelines/for-health-professionals/index.php

9.     Cranston JM, Crockett A, Currow D. Oxygen therapy for dyspnoea in adults. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD004769.

10.  Crockett AJ, Cranston JM, Antic N. Domiciliary oxygen for interstitial lung disease. In: The Cochrane Library, Volume 4, 2001. ©The Cochrane Collaboration; 2001.

11.  NCD for Home use Oxygen (240.2) Publication Number 100-3

12.  Cigna: Oxygen for Home Use; Policy Number 0207 (10:2010)

13.  National Heritage Insurance Company (LCD) L11468; Oxygen and Oxygen Equipment.

14.  Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med 1980; 93:391.

15.  Zieliński J. Long-term oxygen therapy in conditions other than chronic obstructive pulmonary disease. Respir Care 2000; 45:172.

16.  Petty TL, O'Donohue WJ Jr. Further recommendations for prescribing, reimbursement, technology development, and research in long-term oxygen therapy. Summary of the Fourth Oxygen Consensus Conference, Washington, D.C., October 15-16, 1993. Am J Respir Crit Care Med 1994; 150:875.

17.  Fletcher EC, Miller J, Divine GW, et al. Nocturnal oxyhemoglobin desaturation in COPD patients with arterial oxygen tensions above 60 mm Hg. Chest 1987; 92:604.

Fletcher EC, Luckett RA, Goodnight-White S, et al. A double-blind trial of nocturnal supplemental oxygen for sleep desaturation in patients with chronic obstructive pulmonary disease and a daytime PaO2 above 60 mm Hg. Am Rev Respir Dis 1992; 145:1070.

Codes

Applicable Modifiers

N/A

Policy History