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1 Clinical Policy Title: Home, domiciliary and portable oxygen Clinical Policy Number: 07.02.04 Effective Date: October 1, 2014 Initial Review Date: April 19, 2014 Most Recent Review Date: April 10, 2018 Next Review Date: April 2019 Related policies: CP# 07.02.01 Pulmonary rehabilitation CP# 07.01.01 Treatment for obstructive sleep apnea in adults ABOUT THIS POLICY: Prestige Health Choice has developed clinical policies to assist with making coverage determinations. Prestige Health Choice’s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies, along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by Prestige Health Choice when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Prestige Health Choice’s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Prestige Health Choice’s clinical policies are reflective of evidence- based medicine at the time of review. As medical science evolves, Prestige Health Choice will update its clinical policies as necessary. Prestige Health Choice clinical policies are not guarantees of payment. Coverage policy Prestige Health Choice considers the use of home, domiciliary, and portable oxygen to be clinically proven and, therefore, medically necessary for treatment of hypoxemia in members with either severe lung disease or hypoxia-related symptoms or findings that might be expected to improve with oxygen therapy, when any of the following criteria are met: Continuous oxygen therapy (Qaseem, 2011; Raghu, 2011): Arterial partial pressure of oxygen (PaO2) at or below 55 mm Hg, or arterial oxygen saturation (SaO2) at or below 88 percent, taken at rest, breathing room air. PaO2 56 – 59 mm Hg or SaO2 of 89 percent at rest (awake) and evidence of: - Dependent edema suggesting congestive heart failure. Policy contains: Continuous-use oxygen therapy. Intermittent oxygen use. Ambulatory oxygen therapy.
Transcript
Page 1: Home, domiciliary and portable oxygen - Prestige Health Choice · Home, domiciliary and portable oxygen supply systems Medical necessity criteria Oxygen concentrators —stationary

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Clinical Policy Title: Home, domiciliary and portable oxygen

Clinical Policy Number: 07.02.04

Effective Date: October 1, 2014

Initial Review Date: April 19, 2014

Most Recent Review Date: April 10, 2018

Next Review Date: April 2019

Related policies:

CP# 07.02.01 Pulmonary rehabilitation

CP# 07.01.01 Treatment for obstructive sleep apnea in adults

ABOUT THIS POLICY: Prestige Health Choice has developed clinical policies to assist with making coverage determinations. Prestige Health

Choice’s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies, along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of “medically necessary,” and the specific facts of the particular situation are considered by Prestige Health Choice when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Prestige Health Choice’s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Prestige Health Choice’s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Prestige Health Choice will update its clinical policies as necessary. Prestige Health Choice clinical policies are not guarantees of payment.

Coverage policy

Prestige Health Choice considers the use of home, domiciliary, and portable oxygen to be clinically proven

and, therefore, medically necessary for treatment of hypoxemia in members with either severe lung

disease or hypoxia-related symptoms or findings that might be expected to improve with oxygen therapy,

when any of the following criteria are met:

Continuous oxygen therapy (Qaseem, 2011; Raghu, 2011):

Arterial partial pressure of oxygen (PaO2) at or below 55 mm Hg, or arterial oxygen saturation

(SaO2) at or below 88 percent, taken at rest, breathing room air.

PaO2 56 – 59 mm Hg or SaO2 of 89 percent at rest (awake) and evidence of:

- Dependent edema suggesting congestive heart failure.

Policy contains:

Continuous-use oxygen

therapy.

Intermittent oxygen use.

Ambulatory oxygen therapy.

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- Pulmonary hypertension or cor pulmonale, determined by measurement of pulmonary

artery pressure, gated blood pool scan, echocardiogram, or "P" pulmonale on

electrocardiogram.

- Erythrocythemia with a hematocrit greater than 56 percent.

For infants and children, PaO2 at or below 60 mm Hg or SaO2 at or below 92 percent (Balfour-

Lynn, 2009; American Association for Respiratory Care, 2007; Allen, 2003):

During sleep only, when both criteria are met (Balfour-Lynn, 2009; American Association for Respiratory

Care, 2007; Morgenthaler, 2006; American Thoracic Society, 2005; Allen, 2003):

Nocturnal hypoxemia without evidence of daytime hypoxemia defined as either:

- A PaO2 at or below 55 mm Hg, or an SaO2 at or below 88 percent, measured during

sleep for a member who demonstrates a PaO2 at or above 56 mm Hg, or an SaO2 at or

above 89 percent, while awake.

- A greater than normal fall in oxygen level during sleep (a decrease in PaO2 more than

10 mm Hg, or a decrease in SaO2 greater than 5 percent) associated with symptoms

(e.g., impairment of cognitive processes and nocturnal restlessness or insomnia) or

signs (e.g., pulmonary hypertension, cor pulmonale, P pulmonale, or erythrocytosis

with a hematocrit greater than 56 percent) reasonably attributable to hypoxemia.

Other causes of nocturnal hypoxemia (e.g., obstructive sleep apnea, other nocturnal apnea, or

hypoventilation syndromes) have been ruled out or optimally treated according to standard of

care (e.g., continuous positive airway pressure or noninvasive positive pressure ventilation).

During exercise only, when both criteria are met (American Association for Respiratory Care, 2007;

American Thoracic Society, 1999):

• A PaO2 at or below 55 mm Hg or an SaO2 at or below 88 percent, for a patient who

demonstrates an PaO2 at or above 56 mm Hg, or an SaO2 at or above 89 percent, during the day

while at rest.

• Documentation shows supplemental oxygen improves the hypoxemia demonstrated during

exercise while breathing room air.

Short-term use (generally less than 1 month) for other hypoxia-related diagnoses, symptoms, or findings

that might be expected to improve with oxygen such as cognitive impairment, nocturnal restlessness,

croup, or pneumonia (Balfour-Lynn, 2009).

Short-term use for conditions unrelated to hypoxemia (Hardinge, 2015; American Association for

Respiratory Care, 2007):

Cluster headache defined as at least five severe to very severe unilateral headache attacks

lasting 15 minutes ‒ 180 minutes when untreated. The degree or intensity of pain is usually

expressed in terms of its functional consequence and scored on a verbal five-point scale.

Hemoglobinopathies.

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Infants with bronchopulmonary dysplasia who may have variable oxygen needs, to be

considered on a case-by-case basis in the absence of documentation of otherwise qualifying

oxygen saturation values.

Prestige Health ChoicePrestige Health Choice

Prestige Health Choice considers the use of the following oxygen supply systems and associated

administration devices to be medically necessary for members with hypoxemia who meet the above criteria

(Qaseem, 2011; American Association for Respiratory Care, 2007; American Thoracic Society, 2005):

Home, domiciliary and portable

oxygen supply systems Medical necessity criteria

Oxygen concentrators —stationary

and/or portable.

Stationary: For members who do not regularly go beyond the limits of a

stationary oxygen delivery system with 50-ft. tubing or those who use

oxygen only during sleep.

Portable: For members who are regularly (at least monthly) away from

home for durations that exceed the capacity of ambulatory oxygen

systems.

Oxygen cylinders — large reservoir

tanks, H or K cylinders; smaller

cylinders D or E for portability; and

liquid oxygen systems.

Stationary: For members who do not regularly go beyond the limits of a

stationary oxygen delivery system with 50-ft. tubing or those who use

oxygen only during sleep. Cast iron and/or aluminum cylinders.

Portable: For members who occasionally go beyond the limits of a

stationary oxygen delivery system with 50-ft. tubing for less than two hours

per day for most days of the week (minimum two hours/week).

Oxygen transfilling systems: when the medical necessity criteria listed

above for portable oxygen systems are met and the individual is mobile

within the home.

Ambulatory systems that weigh less

than 10 lbs. when filled with oxygen

and are designed to be carried by the

member, and will last for four hours at

a flow equivalent to 2 L/min continuous

flow; e.g., liquid refillable units and

aluminum or fiber-wrapped lightweight

cylinders, with or without oxygen

conserving devices.

For members who regularly go beyond the limits of a stationary oxygen

delivery system with 50-ft. tubing for two hours or more per day and for

most days of the week (minimum six hours/week).

Limitations:

Coverage determinations are subject to benefit limitations and exclusions as delineated by the state

Medicaid authority. The Florida Medicaid website may be accessed at

http://ahca.myflorida.com/Medicaid/.

All other uses of home, domiciliary, and portable oxygen are not medically necessary, including the

following conditions:

Angina pectoris in the absence of hypoxemia. This condition is generally not the result of a low

oxygen level in the blood, and there are other preferred treatments.

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Breathlessness without cor pulmonale or evidence of hypoxemia. Although intermittent oxygen

use is sometimes prescribed to relieve this condition, it is potentially harmful and

psychologically addicting.

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

extremities but in the absence of systemic hypoxemia. There is no evidence that increased PaO2

improves the oxygenation of tissues with impaired circulation.

Terminal illnesses that do not affect the lungs.

Primary treatment for obstructive sleep apnea, other nocturnal apnea, or hypoventilation

syndromes (Qaseem, 2013; Morgenthaler, 2006).

A second oxygen tank (spare tank) is not medically necessary, except for members who are dependent on

either continuous oxygen or an oxygen concentrator.

Portable oxygen is not medically necessary when used only during sleep.

The need for ongoing home, domiciliary, or portable oxygen must be demonstrated by blood gas results or

pulse oximetry performed by the individual’s attending physician or an independent respiratory

practitioner, either:

One month after initiation of therapy for conditions that may be expected to be short-term,

such as pneumonia, asthma, bronchitis, or bronchiolitis.

Three months after initiation of therapy for other conditions to determine acute or chronic

need for oxygen.

Rental of airline oxygen tanks is medically necessary when members meet the criteria for oxygen for home

use listed above and are not allowed to use their own portable oxygen tanks on airplanes.

Alternative covered services:

Smoking cessation programs.

Pharmacologic therapy.

Pulmonary rehabilitation, education, and self-management.

End of life and palliative care.

Surgery and endoscopy.

Background

Home oxygen therapy provides supplemental oxygen for short-term, intermittent use, continuous (long-

term) use, and ambulation with the intent of treating or preventing the symptoms and manifestations of

hypoxia (American Thoracic Society, 2005). Most indications for home oxygen therapy are related to

relieving hypoxia, but medical conditions that respond to supplemental oxygen may benefit from home

use.

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Home oxygen systems are either stationary or ambulatory (American Association for Respiratory Care,

2007). Stationary oxygen systems are delivered by a concentrator, compressed gas, or liquid. The major

disadvantages of liquid oxygen are frequent refilling due to oxygen evaporation, even if not used, and

variable supply of liquid-oxygen systems. Oxygen concentrators are currently the most convenient and

economical method of providing domiciliary long-term oxygen therapy. The choice of system will depend

upon availability, cost, and patient suitability.

Ambulatory oxygen therapy provides oxygen during exercise and for activities of daily living to patients on

long-term oxygen therapy who are mobile and need to, or can, leave the home on a regular basis.

Ambulatory oxygen systems should weigh less than 10 lbs. and provide oxygen at least 2 L/minute for at

least four hours. The patient must be able to carry the device during activities of daily living. The choice of

portable device depends on the patient's mobility and includes continuous oxygen delivery systems, high-

flow nasal cannula, portable oxygen tanks, and oxygen conserving devices (American Thoracic Society,

2005).

Searches

Prestige Health Choice searched PubMed and the databases of:

UK National Health Services Centre for Reviews and Dissemination.

Agency for Healthcare Research and Quality’s Guideline Clearinghouse and evidence-based

practice centers.

The Centers for Medicare & Medicaid Services (CMS).

We conducted searches on March 1, 2018. Search terms were: “Oxygen Inhalation Therapy/therapeutic

use” (MeSH), “Oxygen Inhalation Therapy/therapy” (MeSH), “Home Care Services” (MeSH), “Home Care

Services, Hospital-Based” (MeSH), and the free text terms “continuous oxygen” and “home oxygen.”

We included:

Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and

greater precision of effect estimation than in smaller primary studies. Systematic reviews use

predetermined transparent methods to minimize bias, effectively treating the review as a

scientific endeavor, and are thus rated highest in evidence-grading hierarchies.

Guidelines based on systematic reviews.

Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple

cost studies), reporting both costs and outcomes — sometimes referred to as efficiency studies

— which also rank near the top of evidence hierarchies.

Findings

The evidence for prescribing long-term oxygen therapy is based on results from two randomized controlled

trials showing a beneficial effect on survival, dyspnea, and functional status in patients with chronic

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obstructive pulmonary disease, few comorbidities, and severe hypoxemia (Medical Research Council, 1981;

Nocturnal Oxygen Therapy Trial, 1980). The rationale for its use in patients with other severe hypoxemic

conditions rests on extrapolation of data from patients with chronic obstructive pulmonary disease. Limited

evidence supports intermittent home oxygen therapy to treat persons with cluster headaches,

hemoglobinopathies, and signs of tissue hypoxia (e.g., pulmonary hypertension, cor pulmonale,

erythrocytosis, or impaired mental status).

There is less certainty regarding the value of home oxygen therapy for patients with mild to moderate

hypoxemia, only arterial desaturation at night, or temporary hypoxemia due to a clinically unstable

condition. Ambulatory oxygen from a liquid source or lightweight cylinders modestly improves disease-

specific quality of life in selected patients who participate in regular outdoor activity. Desaturation only

during exercise or sleep suggests consideration of oxygen therapy specifically under those conditions.

Likewise, patients with adequate PaO2 who have severe dyspnea relieved by low-flow oxygen or patients

who are limited in their exertional capacity but improve their exercise performance with supplemental

oxygen warrant consideration of oxygen therapy.

Palliative oxygen is frequently prescribed to manage dyspnea in people with advanced life-limiting illness,

despite a lack of evidence and clinical practice guidelines supporting its use for patients with PaO2 greater

than 55 mm Hg (American Association for Respiratory Care, 2007). Prescribing tends to be based on

symptoms or patient request irrespective of PaO2 or oximetry. The uncertainty of the benefit of palliative

oxygen has led to inconsistent access and variable utilization. Quality care for people with life-limiting

illness and refractory symptoms requires the judicious use of oxygen through careful monitoring of

symptoms using basic standardized scales, guided by patient preference.

Initiation of oxygen therapy requires direct measurement of arterial blood gas tensions off and on oxygen

therapy for 30 minutes to determine the presence of hypercapnia or respiratory acidosis. Indirect

measurement of oxygen saturation using pulse oximetry is not adequate for initiating long-term oxygen

therapy, but it may be used for titrating oxygen flow over time (American Association for Respiratory Care,

2007; American Thoracic Society, 2005). However, pulse oximetry is an acceptable alternative for infants

and children (Balfour-Lynn, 2009).

The therapeutic goal is to maintain SaO2 greater than 90 percent during rest, sleep, and exertion.

Physiological indications for long-term oxygen therapy include (Qaseem, 2011):

PaO2 less than 55 mm Hg corresponding to an SaO2 at or below 88 percent.

PaO2 of 55 - 59 mm Hg corresponding to an SaO2 of 89 percent and exhibiting signs of tissue

hypoxia, such as pulmonary hypertension, cor pulmonale, erythrocytosis, edema from right

heart failure, or impaired mental status.

PaO2 at or above 60 mm Hg corresponding to an SaO2 at or above 90 percent in persons who

experience desaturation only during exercise or sleep, or with lung disease with severe dyspnea

that responds to oxygen therapy.

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Standards for continuing oxygen therapy depend on whether it is prescribed for the first time during an

acute exacerbation, or at a time when the patient is relatively stable and receiving optimal therapy.

Patients should be evaluated one month after initiation of therapy for conditions that may be expected to

be short-term (e.g., pneumonia, asthma, bronchitis, or bronchiolitis), and after three months to identify

initially eligible patients who may have acute or chronic need and to ensure adherence to the hypoxemia

criteria (American Association for Respiratory Care, 2007). Following a three-month initial evaluation, pulse

oximetry or arterial blood gas results should be reported within 12 months of the initiation of oxygen and

whenever there is an increase in the amount of oxygen or change in the type of oxygen equipment being

requested.

Policy updates:

The long-awaited Long-term Oxygen Treatment Trial (ClinicalTrials.gov number NCT00692198) published

findings for persons with chronic obstructive pulmonary disease who would not meet current criteria for

long-term oxygen therapy (Albert, 2016). Using pulse oximetry, the investigators defined moderate oxygen

desaturation at rest as 89 percent to 93 percent, and during exercise as at least 80 percent for at least five

minutes and less than 90 percent for at least 10 seconds on the six-minute walk test. Long-term oxygen

therapy failed to show significant improvement in time to death or first hospitalization or provide sustained

benefit in health status, lung function, or the six-minute walk test in persons with stable chronic obstructive

pulmonary disease and either moderate resting or exercise-induced oxygen desaturation.

An updated Cochrane review found insufficient evidence to support long-term oxygen therapy in persons

with stable chronic obstructive pulmonary disease and mild or no hypoxemia, again representing persons

who would not meet current criteria for long-term oxygen therapy (Ekstrom, 2016). Another Cochrane

review found insufficient evidence to support using ambulatory and short-burst oxygen for persons with

interstitial lung disease (Sharp, 2016).

Recommendations from the Global Initiative for Chronic Obstructive Lung Disease (2017, updated 2018)

support long-term oxygen therapy in persons with severe resting chronic hypoxemia. They do not

recommend routinely prescribing long-term oxygen therapy for stable patients with chronic obstructive

pulmonary disease and resting or exercise-induced hypoxemia. Rather, prescription for long-term oxygen

therapy should be based on individual assessment of symptoms and future risk of exacerbations. These

results are consistent with previous findings and warrant no changes to the policy at this time.

In 2018, we added several seminal guidelines that have provided the basis for the current standards of care

for prescribing home oxygen therapy for several years (Qaseem, 2011; Raghu, 2011; Balfour-Lynn, 2009;

American Association for Respiratory Care, 2007; Morgenthaler, 2006; Allen, 2003). We clarified the criteria

for medical necessity for supplemental oxygen during sleep. Current guidelines do not recommend

supplemental oxygen as a primary treatment for oxygen desaturation associated with sleep disorders. In

addition to the existing laboratory criteria, we added a statement requiring that other causes of nocturnal

hypoxemia (e.g., obstructive sleep apnea, other nocturnal apnea, or hypoventilation syndromes) be ruled

out or optimally treated according to standard of care (e.g., continuous positive airway pressure or

noninvasive positive pressure ventilation) before oxygen is prescribed for this condition.

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Summary of clinical evidence:

Citation Content, Methods, Recommendations

Global Initiative for

Chronic Obstructive

Lung Disease (2018)

Guideline for chronic

obstructive pulmonary

disease

Key points:

In patients with severe resting chronic hypoxemia, long-term oxygen therapy improves

survival.

For stable patients with chronic obstructive pulmonary disease and mild-to-moderate

resting or exercise-induced hypoxemia, long-term oxygen therapy should not be

prescribed routinely. However, individual patient factors should be considered when

evaluating the need for oxygen (e.g., reduction of symptoms and future risk of

exacerbations).

Recommendation based on results of the Long-term Oxygen Therapy Trial.

Albert (2016)

Long-term Oxygen

Therapy Trial

Key points:

A randomized controlled trial of 738 patients with stable chronic obstructive pulmonary

disease with moderate oxygen desaturation at rest (pulse oximetry [SpO2] 89% to 93%)

or during exercise (SpO2 at or above 80% for at least 5 minutes and less than 90% for

at or above 10 seconds on six-minute walk test) who received long-term oxygen

therapy or no oxygen and were followed for one to six years. In the supplemental-

oxygen group, patients with resting desaturation were prescribed 24-hour oxygen, and

those with desaturation only during exercise were prescribed oxygen during exercise

and sleep.

Long-term oxygen therapy did not improve patient outcomes (time to death or first

hospitalization composite outcome) in the rates of all hospitalizations, exacerbations, or

hospitalizations related to chronic obstructive pulmonary disease, or in measures of

quality of life, lung function, or the six-minute walk test.

Ekstrom (2016)

Cochrane review

Oxygen for

breathlessness in

patients with chronic

obstructive pulmonary

disease who do not

qualify for home oxygen

therapy

Key points:

Systematic review of 28 studies (702 participants); meta-analysis included 18

randomized controlled trials (431 participants).

Overall quality: low. Significant heterogeneity across studies.

Oxygen can relieve dyspnea in mildly hypoxemic and non-hypoxemic patients with

chronic obstructive pulmonary disease who would not otherwise meet criteria for home

oxygen therapy.

Insufficient evidence to support routine home oxygen therapy.

2016 update: added 14 new randomized controlled trials (493 participants). Low-quality

evidence suggests supplemental oxygen can reduce dyspnea during exercise, but not

in the daily life setting or health-related quality of life.

Sharp (2016)

Cochrane review

Ambulatory and short-

burst oxygen for

interstitial lung disease

Key points:

Systematic review of three studies (98 total participants in hospital respiratory

physiology laboratories).

Overall quality: low.

Conflicting results of any beneficial effect of supplemental oxygen on exercise capacity

or exertional dyspnea. No studies examined health-related quality of life, survival,

costs, time-to-exacerbation or -hospitalization, or reported adverse events.

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Citation Content, Methods, Recommendations

Ameer (2014)

Cochrane review

Ambulatory oxygen

therapy in patients with

chronic obstructive

pulmonary disease who

do not meet criteria for

long-term oxygen

therapy

Key points:

Systematic review of four randomized controlled trials (331 participants).

Overall quality: low to moderate. Underpowered, moderate risk of bias based on study

designs.

For patients with chronic obstructive pulmonary disease and moderate hypoxemia,

ambulatory oxygen therapy improves dyspnea after exercise and in the dyspnea and

fatigue domain of quality of life, but inconclusive for improving mortality and exercise

capacity.

Methodologically rigorous randomized controlled trials with sufficient power are

needed.

Petersen (2014)

Oxygen therapy for

cluster headache

Key points:

Systematic review of five small randomized controlled trials and one observational

study.

Efficacy of low-flow oxygen (6 – 7 L/m) ranged 56 percent to 82 percent in three

studies. High-flow oxygen (12 L/min) was effective in 78 percent of attacks in one

study.

Limited evidence that oxygen treatment is effective and safe. However, logistic and

financial concerns restrict access to oxygen in this population.

Elphick (2013)

Cochrane review

Oxygen therapy in

cystic fibrosis

Key points:

Systematic review of 11 randomized controlled trials or quasi-randomized controlled

trials (172 participants): one studied long-term oxygen therapy (28 participants), four

studied oxygen supplementation during sleep by polysomnography, and six studied

oxygen supplementation during exercise.

Short-term oxygen therapy during sleep and exercise improves oxygenation but is

associated with modest and probably clinically inconsequential hypercapnia. There are

improvements in exercise duration, time to fall asleep, and regular attendance at school

or work.

Qaseem (2011, based

on 2007 guideline) for

the American Thoracic

Society

Guideline: diagnosis

and management of

stable chronic

obstructive pulmonary

disease

Key points:

Supplemental oxygen used at or above15 hours daily to maintain a PaO2 greater than

60 mm Hg reduced mortality in patients with severe resting hypoxemia (mean resting

PaO2 at or less than 55 mm Hg).

Supplemental oxygen (9 to 13 hours daily) showed no effect on relative risk for

mortality with use of supplemental oxygen during the day or at night in patients with

similar severity of airflow obstruction but daytime PaO2 greater than 60 mm Hg.

Ambulatory oxygen has no effect on respiratory health-related quality of life measures.

Physiologic indications include cor pulmonale or polycythemia with PaO2 between 55

and 59 mm Hg.

Raghu (2011) for the

American Thoracic

Society

Guideline: idiopathic

pulmonary fibrosis

Key points:

Strong recommendation for long-term oxygen therapy in patients with interstitial

pulmonary fibrosis and clinically significant resting hypoxemia (SpO2 less than 88%); a

PaO2 cutoff could not be determined.

Recommendation based on indirect evidence from studies of chronic obstructive

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Citation Content, Methods, Recommendations

pulmonary disease and very low-quality evidence of improvement in exercise capacity

in patients with resting hypoxemia using oxygen.

Balfour-Lynn (2009) for

the British Thoracic

Society

Guidelines for home

oxygen in children

Key points:

Pulse oximetry should be used to assess hypoxemia and need for oxygen.

Target levels vary with lung condition and age, but in general oxygen therapy should be

given to maintain a SpO2 greater than 93% for children with chronic neonatal lung

disease, although greater than 94% may be appropriate for sickle cell disease and

greater than 90% for cystic fibrosis.

Continuous oxygen therapy may be indicated for a variety of chronic lung conditions or

congenital conditions associated with hypoxemia.

American Association

for Respiratory Care

(2007)

Guideline: oxygen

therapy in the home or

alternate site health

care facility

Key points:

Indicated for hypoxemia in adults, children, and infants older than 28 days as

evidenced by:

- PaO2 at or less than 55 mm Hg or SaO2 at or less than 88% on room air.

- PaO2 of 56-59 mm Hg or SaO2 or pulse oximetry at or less than 89% in

association with specific clinical conditions (e.g., cor pulmonale, congestive

heart failure, or erythrocythemia with hematocrit greater than 56).

- During ambulation, sleep, or exercise, oxygen therapy when SaO2 at or less

than 88%.

- Dyspnea with hypoxemia at end-of-life.

Indicated for other conditions where strong evidence may be lacking (e.g., cluster

headaches) on the order and discretion of the attending physician.

Morgenthaler (2006) for

the American Academy

of Sleep Medicine

Practice parameters for

the medical therapy of

obstructive sleep apnea

Key points:

Oxygen supplementation is not recommended as a primary treatment.

Available studies showed favorable effects on oxygenation, but the effect of oxygen

therapy on apneas, hypopneas, and subjective sleepiness was inconsistent.

Allen (2003) for the

American Thoracic

Society

Statement on the care

of the child with chronic

lung disease of infancy

and childhood

Key points:

Bronchopulmonary dysplasia refers to chronic lung disease subsequent to oxygen

and/or ventilator therapy for respiratory distress syndrome in preterm newborns, or in

full-term newborns subsequent to mechanical ventilation for other neonatal respiratory

conditions.

Chronic lung disease of prematurity refers to other chronic lung diseases of the preterm

infant that can arise after an initial period without an oxygen or ventilatory requirement.

Home oxygen may be indicated for young patients with chronic lung disease of infancy

who experience oxygen desaturation on room air, with target SaO2 levels generally 90-

95% depending on gestational age at birth.

Pulse oximetry is an acceptable oxygen saturation measurement, even in the presence of carbon dioxide retention.

References

Professional society guidelines/other:

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AARC clinical practice guideline. Oxygen therapy in the home or alternate site health care facility--2007

revision & update. Respir Care. 2007; 52(8): 1063 – 1068. Available at:

http://rc.rcjournal.com/content/respcare/52/8/1063.full.pdf. Accessed March 1, 2018.

Allen J, Zwerdling R, Ehrenkranz R, et al. Statement on the care of the child with chronic lung disease of

infancy and childhood. Am J Respir Crit Care Med. 2003; 168(3): 356 – 396. DOI: 10.1164/rccm.168.3.356.

American Thoracic Society. Dyspnea. Mechanisms, assessment, and management: a consensus statement.

Am J Respir Crit Care Med. 1999; 159(1): 321-340. DOI: 10.1164/ajrccm.159.1.ats898.

American Thoracic Society. Statement on home care for patients with respiratory disorders. Am J Respir Crit

Care Med. 2005; 171(12): 1443 – 1464. DOI: 10.1164/rccm.2504001.

Balfour-Lynn IM, Field DJ, Gringras P, et al. BTS guidelines for home oxygen in children. Thorax. 2009; 64

Suppl 2: ii1 – 26. DOI: 10.1136/thx.2009.116020.

From the Global Strategy for the Diagnosis, Management and Prevention of chronic obstructive pulmonary

disease, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2018. GOLD website.

http://goldcopd.org/wp-content/uploads/2017/11/GOLD-2018-v6.0-FINAL-revised-20-Nov_WMS.pdf.

Accessed March 1, 2018.

Hardinge M, Annandale J, Bourne S, et al. British Thoracic Society guidelines for home oxygen use in adults.

Thorax. 2015; 70 Suppl 1: i1 – 43. DOI: 10.1136/thoraxjnl-2015-206865.

Qaseem A, Holty JE, Owens DK, et al. Management of Obstructive Sleep Apnea in Adults: A Clinical Practice

Guideline From the American College of Physicians. Ann Intern Med. 2013; 159(7): 471-483. DOI:

10.7326/0003-4819-159-7-201310010-00704.

Qaseem A, Wilt TJ, Weinberger SE, et al. Diagnosis and management of stable chronic obstructive

pulmonary disease: a clinical practice guideline update from the American College of Physicians, American

College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med.

2011; 155(3): 179 – 191. DOI: 10.7326/0003-4819-155-3-201108020-00008.

Raghu G, Collard HR, Egan JJ, et al. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis:

evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011; 183(6): 788 –

824. DOI: 10.1164/rccm.2009-040GL.

National Institute for Clinical Excellence (NICE). CG101. Chronic obstructive pulmonary disease in over 16s:

diagnosis and management. June, 2010. NICE website.

http://guidance.nice.org.uk/CG101/Guidance/pdf/English. Accessed March 2, 2018.

Peer-reviewed references:

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Albert RK, Au DH, Blackford AL, et al. A Randomized Trial of Long-Term Oxygen for COPD with Moderate

Desaturation. N Engl J Med. 2016; 375(17): 1617 – 1627. DOI: 10.1056/NEJMoa1604344.

Ameer F, Carson KV, Usmani ZA, Smith BJ. Ambulatory oxygen for people with chronic obstructive

pulmonary disease who are not hypoxaemic at rest. Cochrane Database Syst Rev. 2014; 6: Cd000238. DOI:

10.1002/14651858.CD000238.pub2.

Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial.

Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980; 93(3): 391 – 398. DOI: 10.7326/0003-4819-

93-3-391.

Ekstrom M, Ahmadi Z, Bornefalk-Hermansson A, Abernethy A, Currow D. Oxygen for breathlessness in

patients with chronic obstructive pulmonary disease who do not qualify for home oxygen therapy.

Cochrane Database Syst Rev. 2016; 11: Cd006429. DOI: 10.1002/14651858.CD006429.pub3.

Elphick HE, Mallory G. Oxygen therapy for cystic fibrosis. Cochrane Database Syst Rev. 2013; 7: Cd003884.

DOI: 10.1002/14651858.CD003884.pub4.

Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and

emphysema. Report of the Medical Research Council Working Party. Lancet. 1981; 1(8222): 681 – 686. DOI:

10.1016/S0140-6736(81)91970-X.

Petersen AS, Barloese MC, Jensen RH. Oxygen treatment of cluster headache: a review. Cephalalgia. 2014;

34(13): 1079 – 1087. DOI: 10.1177/0333102414529672.

Sharp C, Adamali H, Millar AB. Ambulatory and short-burst oxygen for interstitial lung disease. Cochrane

Database Syst Rev. 2016; 7: Cd011716. DOI: 10.1002/14651858.CD011716.pub2.

CMS National Coverage Determinations:

240.2.2 Home Oxygen Use to Treat Cluster Headache (CH). CMS website. http://www.cms.gov/medicare-

coverage-database/details/ncd-details.aspx?NCDId=343&ver=1. Accessed March 2, 2018.

240.2 Home Use of Oxygen. CMS website. http://www.cms.gov/medicare-coverage-database/details/ncd-

details.aspx?NCDId=169&ver=1. Accessed March 2, 2018.

240.2.1 Home Use of Oxygen in Approved Clinical Trials. CMS website. https://www.cms.gov/medicare-

coverage-database/details/ncd-details.aspx?NCDId=312&ver=1. Accessed March 2, 2018.

Local Coverage Determinations:

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A52514 Oxygen and Oxygen Equipment - Policy Article. CMS website. https://www.cms.gov/medicare-

coverage-database/details/article-details.aspx?articleId=52514&ver=9 . Accessed March 2, 2018.

L33797 Oxygen and Oxygen Equipment. CMS website. https://www.cms.gov/medicare-coverage-

database/details/lcd-details.aspx?LCDId=33797&ver=10. Accessed March 2, 2018.

Commonly submitted codes

Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not

an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill

accordingly.

CPT Code Description Comment

N/A

ICD-10 Code Description Comment

A22.1 Pulmonary anthrax

A37.01 Whooping cough due to Bordetella pertussis with pneumonia

A37.11 Whooping cough due to Bordetella parapertussis with pneumonia

A37.81 Whooping cough due to other Bordetella species with pneumonia

A37.91 Whooping cough, unspecified species with pneumonia

A48.1 Legionnaires' disease

B25.0 Cytomegaloviral pneumonitis

B44.0 Invasive pulmonary aspergillosis

B77.81 Ascariasis pneumonia

C34.00 Malignant neoplasm of unspecified main bronchus

C34.01 Malignant neoplasm of right main bronchus

C34.02 Malignant neoplasm of left main bronchus

C34.10 Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11 Malignant neoplasm of upper lobe, right bronchus or lung

C34.12 Malignant neoplasm of upper lobe, left bronchus or lung

C34.2 Malignant neoplasm of middle lobe, bronchus or lung

C34.30 Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31 Malignant neoplasm of lower lobe, right bronchus or lung

C34.32 Malignant neoplasm of lower lobe, left bronchus or lung

C34.80 Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82 Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90 Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91 Malignant neoplasm of unspecified part of right bronchus or lung

C34.92 Malignant neoplasm of unspecified part of left bronchus or lung

C78.00 Secondary malignant

C78.01 Secondary malignant neoplasm of right lung

C78.02 Secondary malignant neoplasm of left lung

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ICD-10 Code Description Comment

D02.20 Carcinoma in situ of unspecified bronchus and lung

D02.21 Carcinoma in situ of right bronchus and lung

D02.22 Carcinoma in situ of left bronchus and lung

D14.30 Benign neoplasm of unspecified bronchus and lung

D14.31 Benign neoplasm of right bronchus and lung

D14.32 Benign neoplasm of left bronchus and lung

D56.4 Hereditary persistence of fetal hemoglobin [HPFH]

D56.8 Other thalassemias

D57.1 Sickle-cell disease without crisis

D57.20 Sickle-cell/Hb-C disease without crisis

D57.20 Sickle-cell/Hb-C disease without crisis

D57.211 Sickle-cell/Hb-C disease with acute chest syndrome

D57.212 Sickle-cell/Hb-C disease with splenic sequestration

D57.219 Sickle-cell/Hb-C disease with crisis, unspecified

D57.40 Sickle-cell thalassemia without crisis

D57.411 Sickle-cell thalassemia with acute chest syndrome

D57.412 Sickle-cell thalassemia with splenic sequestration

D57.419 Sickle-cell thalassemia with crisis, unspecified

D57.80 Other sickle-cell disorders without crisis

D57.811 Other sickle-cell disorders with acute chest syndrome

D57.812 Other sickle-cell disorders with splenic sequestration

D57.819 Other sickle-cell disorders with crisis, unspecified

D58.1 Hereditary elliptocytosis

D58.2 Other hemoglobinopathies

D75.0 Familial erythrocytosis

D75.1 Secondary polycythemia

E84.0 Cystic fibrosis with pulmonary manifestations

E84.8 Cystic fibrosis with other manifestations

E84.9 Cystic fibrosis, unspecified

G44.001 Cluster headache syndrome, unspecified, intractable

G44.009 Cluster headache syndrome, unspecified, not intractable

G44.011 Episodic cluster headache, intractable

G44.019 Episodic cluster headache, not intractable

G44.021 Chronic cluster headache, intractable

G44.029 Chronic cluster headache, not intractable

I26.01 Septic pulmonary embolism with acute cor pulmonale

I26.02 Saddle embolus of pulmonary artery with acute cor pulmonale

I26.09 Other pulmonary embolism with acute cor pulmonale

I27.0 Primary pulmonary hypertension

I27.1 Kyphoscoliotic heart disease

I27.2 Other secondary pulmonary hypertension

I27.82 Chronic pulmonary embolism

I27.89 Other specified pulmonary heart diseases

I50.20 Unspecified systolic (congestive) heart failure

I50.21 Acute systolic (congestive) heart failure

I50.22 Chronic systolic (congestive) heart failure

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ICD-10 Code Description Comment

I50.23 Acute on chronic systolic (congestive) heart failure

I50.30 Unspecified diastolic (congestive) heart failure

I50.31 Acute diastolic (congestive) heart failure

I50.32 Chronic diastolic (congestive) heart failure

I50.33 Acute on chronic diastolic (congestive) heart failure

I50.40

Unspecified combined systolic (congestive) and diastolic (congestive) heart

failure

I50.41 Acute combined systolic (congestive) and diastolic (congestive) heart failure

I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure

I50.43

Acute on chronic combined systolic (congestive) and diastolic (congestive)

heart failure

I50.9 Heart failure, unspecified

J05.0 Acute obstructive laryngitis [croup]

J12.0 Adenoviral pneumonia

J12.1 Respiratory syncytial virus pneumonia

J12.2 Parainfluenza virus pneumonia

J12.3 Human metapneumovirus pneumonia

J12.81 Pneumonia due to SARS-associated coronavirus

J12.89 Other viral pneumonia

J12.9 Viral pneumonia, unspecified

J13 Pneumonia due to Streptococcus pneumonia

J14 Pneumonia due to Hemophilus influenza

J15.0 Pneumonia due to Klebsiella pneumonia

J15.1 Pneumonia due to Pseudomonas

J15.20 Pneumonia due to staphylococcus, unspecified

J15.211 Pneumonia due to Methicillin susceptible Staphylococcus aureus

J15.212 Pneumonia due to Methicillin resistant Staphylococcus aureus

J15.29 Pneumonia due to other staphylococcus

J15.3 Pneumonia due to streptococcus, group B

J15.4 Pneumonia due to other streptococci

J15.5 Pneumonia due to Escherichia coli

J15.6 Pneumonia due to other aerobic Gram-negative bacteria

J15.7 Pneumonia due to Mycoplasma pneumoniae

J15.8 Pneumonia due to other specified bacteria

J15.9 Unspecified bacterial pneumonia

J16.0 Chlamydial pneumonia

J16.8 Pneumonia due to other specified infectious organisms

J17 Pneumonia in diseases classified elsewhere

J18.0 Bronchopneumonia, unspecified organism

J18.1 Lobar pneumonia, unspecified organism

J18.8 Other pneumonia, unspecified organism

J18.9 Pneumonia, unspecified organism

J40 Bronchitis, not specified as acute or chronic

J41.0 Simple chronic bronchitis

J41.1 Mucopurulent chronic bronchitis

J41.8 Mixed simple and mucopurulent chronic bronchitis

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ICD-10 Code Description Comment

J42 Unspecified chronic bronchiti

J44.0 Chronic obstructive pulmonary disease with acute lower respiratory infection

J44.1 Chronic obstructive pulmonary disease with (acute) exacerbation

J44.9 Chronic obstructive pulmonary disease, unspecified

J45.20 Mild intermittent asthma, uncomplicated

J45.21 Mild intermittent asthma with (acute) exacerbation

J45.22 Mild intermittent asthma with status asthmaticus

J45.30 Mild persistent asthma, uncomplicated

J45.31 Mild persistent asthma with (acute) exacerbation

J45.32 Mild persistent asthma with status asthmaticus

J45.40 Moderate persistent asthma, uncomplicated

J45.41 Moderate persistent asthma with (acute) exacerbation

J45.42 Moderate persistent asthma with status asthmaticus

J45.50 Severe persistent asthma, uncomplicated

J45.51 Severe persistent asthma with (acute) exacerbation

J45.52 Severe persistent asthma with status asthmaticus

J45.901 Unspecified asthma with (acute) exacerbation

J45.902 Unspecified asthma with status asthmaticus

J45.909 Unspecified asthma, uncomplicated

J45.990 Exercise induced bronchospasm

J45.991 Cough variant asthma

J45.998 Other asthma

J47.0 Bronchiectasis with acute lower respiratory infection

J47.1 Bronchiectasis with (acute) exacerbation

J47.9 Bronchiectasis, uncomplicated

J84.10 Pulmonary fibrosis, unspecified

J84.17

Other interstitial pulmonary diseases with fibrosis in diseases classified

elsewhere

J84.89 Other specified interstitial pulmonary diseases

P27.0 Wilson-Mikity syndrome

P27.1 Bronchopulmonary dysplasia originating in the perinatal period

P27.8 Other chronic respiratory diseases originating in the perinatal period

P27.9 Unspecified chronic respiratory disease originating in the perinatal period

P29.3 Persistent fetal circulation

Q33.4 Congenital bronchiectasis

Z99.81 Dependence on supplemental oxygen

HCPCS

Level II Code Description Comment

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.

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HCPCS

Level II Code Description Comment

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.

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.


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