Prior Authorization Review Panel MCO Policy Submission
A separate copy of this form must accompany each policy submitted for
review. Policies submitted without this form will not be considered for review.
Plan: Aetna Better Health Submission Date: 10/01/2018
Policy Number: 0002 Effective Date: Revision Date:
Policy Name: Oxygen
Type of Submission – Check all that apply: New Policy Revised Policy* Annual Review – No Revisions
*All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy below:
CPB 0002 Oxygen
Clinical content was last revised on 05/03/2016. Additional non-clinical updates were made by Corporate since the last PARP submission, as documented below.
Revision and Update History since last PARP submission: 02/14/2018 - This CPB has been updated with additional background information and references. 01/10/2019 – Next tentative scheduled review date by Corporate .
Name of Authorized Individual (Please type or print):
Dr. Bernard Lewin, M.D.
Signature of Authorized Individual:
www.aetnabetterhealth.com/pennsylvania Updated 02/14/2018
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Oxygen
Number: 0002 *Please see amendment for Pennsylvania Medicaid at the end of this CPB.
Policy
I. Home oxygen therapy is only considered medically
necessary if all of the following conditions are met:
A. The treating physician has determined that
the member has a severe lung disease or hypoxia-
related symptoms that might be expected to
improve with oxygen therapy, and
B. The member's blood gas study meets the criteria
stated below, and
C. The qualifying blood gas study was performed by a
physician or by a qualified provider or supplier of
laboratory services, and
D. The qualifying blood gas study was obtained under
the following conditions:
1. If the qualifying blood gas study is performed
during an inpatient hospital stay, the reported
test must be the one obtained closest to, but no
earlier than 2 days prior to the hospital discharge
date, or
Policy His tory
Last Review
02/14/2018
Effective: 10/06/1995
Next
Review: 01/10/2019
Review History
Definitions
A dditiona l In form at ion
Clinical Policy
Bulletin Notes
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2. If the qualifying blood gas study is not performed
during an inpatient hospital stay and the oxygen
is being prescribed for chronic conditions, the
reported test must be performed while
the member is in a chronic stable state – i.e., not
during a period of acute illness or an
exacerbation of their underlying disease, and
E. Alternative treatment measures have been tried or
considered and deemed clinically ineffective.
In this policy, the term blood gas study refers to
either an oximetry test or an arterial blood gas test.
II. Where the above-listed criteria are met, Aetna considers
oxygen for home use medically necessary durable
medical equipment (DME) in the following
circumstances:
A. Diagnosis of severe lung disease and qualifying lab
values:**
▪ Bronchiectasis
▪ Chronic obstructive pulmonary disease (COPD)
▪ Cystic fibrosis
▪ Diffuse interstitial lung disease
▪ Pediatric broncho-pulmonary dysplasia (BPD)
▪ Widespread pulmonary neoplasm;
B. Diagnosis of other hypoxia-related symptoms or
findings with qualifying lab values:**
▪ Erythrocytosis (hematocrit greater than 55 %)
▪ Pulmonary hypertension
▪ Recurring congestive heart failure due to chronic
cor-pulmonale;
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C. Other diagnoses of hypoxia-related symptoms or
findings with qualifying lab values:** that usually
resolve with limited or short-term oxygen therapy:
▪ Asthma
▪ Bronchitis
▪ Croup
▪ Pneumonia.
Although treatment of these diagnoses (pneumonia, asthma,
croup, bronchitis) may be considered medically necessary for
short-term therapy (generally less than 1 month duration), it
is not considered medically necessary on an ongoing basis
absent special circumstances. Requests for more than
episodic oxygen for these diagnoses are subject to medical
review. For ongoing oxygen treatment, repeat qualifying lab
values are reviewed on a monthly basis.
D. 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:
▪ Cluster headaches that meet the diagnostic
criteria used by the International Headache
Society to form a definitive diagnosis of CH (see
appendix), where the headaches are refractory to
prescription medications.
▪ Hemoglobinopathies. Self-administration of
adjunctive short-term oxygen therapy in the
outpatient setting has been shown to be
beneficial and reduce hospitalizations in
individuals with hemoglobinopathies, such as
hemoglobin sickle cell disease, during vaso-
occlusive crisis exacerbated by hypoxia.
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▪ Infants with BPD may have variable oxygen
needs, thus, consideration on a case-by-case
basis may be required in the absence of
documentation of otherwise qualifying oxygen
saturation values.
Oxygen for home use is considered experimental and
investigational for indications other than those noted above
(e.g., 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:
Continuous Oxygen:
1. Resting (awake) PaO2 less than or equal to 55 mm
Hg or arterial oxygen saturation less than or
equal to 88 %; or
2. 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
▪ Dependent edema suggesting congestive
heart failure
▪ Erythrocythemia (hematocrit greater than 56
%)
▪ Pulmonary hypertension or cor pulmonale,
determined by measurement of pulmonary
artery pressure, gated blood pool scan,
echocardiogram, or "P" pulmonale on the
electrocardiogram (P wave greater than 3 mm
in standard leads II, III, or aVF).
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3. Resting PaO2 greater than 59 mm Hg or oxygen
saturation greater than 89 % only with additional
documentation justifying the oxygen prescription
and a summary of more conservative therapy
that has failed.
Non-continuous Oxygen: (oxygen flow rate and number
of hours per day must be specified)
1. During exercise: PaO2 less than or equal to 55
mm Hg or oxygen saturation less than or equal to
88 % with a low level of exertion. In this case,
provision of oxygen is considered medically
necessary during exercise if it is documented that
the use of oxygen improves the hypoxemia that
was demonstrated during exercise when
the member was breathing room air.
2. During sleep:
a. PaO2 less than or equal to 55 mm Hg or
oxygen saturation less than or equal to 88 %
for at least 5 minutes; or
b. A decrease in PaO2 more than 10 mm Hg, or a
decrease in arterial oxygen saturation more
than 5 percent from baseline saturation, for at
least 5 minutes taken during sleep associated
with symptoms (e.g., impairment of cognitive
processes and [nocturnal restlessness or
insomnia]) or signs (e.g., cor pulmonale, "P"
pulmonale on EKG, documented pulmonary
hypertension and erythrocytosis) reasonably
attributable to hypoxemia.
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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.
III. Oxygen therapy is considered not medically necessary
for all other indications, including the following:
A. 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.
B. Dyspnea without cor pulmonale or evidence of
hypoxemia.
C. 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 PO2
will improve the oxygenation of tissues with
impaired circulation.
D. Terminal illnesses that do not affect the respiratory
system.
IV. 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.
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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”).
▪ Considered medically necessary for members who
occasionally go beyond the limits of a stationary
oxygen delivery system with 50-ft tubing for less
than 2 hours per day for most days of the week
(minimum 2 hours/week).
▪ Preset portable oxygen units are considered not
medically necessary.
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.
▪ Considered medically necessary for members who
regularly go beyond the limits of a stationary oxygen
delivery system with a 50-ft tubing for 2 hours or more
per day and for most days of the week (minimum 6
hours/week).
▪ Prescription based on the activity status of the
member, the appropriate oxygen delivery system will
be delivered.
Portable Oxygen Concentrators: Portable oxygen
concentrators and combination stationary/portable
oxygen systems are considered medically necessary as
an alternative to ambulatory oxygen systems for
members who meet both of the following criteria:
▪ Member meets criteria for ambulatory oxygen
systems (see above); and
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▪ 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.
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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.
V. Reassessment
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.
VI. 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.
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See
CPB 0339 - Pulse Oximetry for Home
Use (../300_399/0339.html)
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,
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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.
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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
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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
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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
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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
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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
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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
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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
they down-graded the quality of evidence to very low. Meta-
analysis of 3 comparable studies showed no differences in
carbon dioxide clearance among those 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
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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.
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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.
Appendix
Documentation Requirements
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
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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:
1. Ipsilateral conjunctival injection and/or lacrimation; or
2. Ipsilateral nasal congestion and/or rhinorrhea; or
3. Ipsilateral eyelid edema; or
4. Ipsilateral forehead and facial sweating; or
5. Ipsilateral miosis and/or ptosis; or
6. A sense of restlessness or agitation
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 "+":
Code Code Description
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:
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Code Code Description
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
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Code Code Description
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
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Code Code Description
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
A4615 Cannula, nasal
A4616 Tubing (oxygen), per foot
A4617 Mouthpiece
A4618 Breathing circuits
A4619 Face tent
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
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Code Code Description
E0455 Oxygen tent, excluding croup or pediatric tents
E0457 Chest shell (cuirass)
E0459 Chest wrap
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
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Code Code Description
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
E1353 Regulator
E1354 Oxygen accessory, wheeled cart for portable
cylinder or portable concentrator, any type,
replacement only, each
E1355 Stand/rack
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):
A22.1 Pulmonary anthrax
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Code Code Description
A37.01,
A37.11,
A37.81,
A37.91
Pneumonia in whooping cough
A48.1 Legionnaires' disease
B25.0 Cytomegaloviral pneumonitis
B44.0 Invasive pulmonary aspergillosis
B77.81 Ascariasis pneumonia
C34.00 - Malignant neoplasm of bronchus and lung
C34.92 C78.00 - Secondary malignant neoplasm of lung
C78.02 C94.00 - Acute erythroid leukemia
C94.02 D02.20 - Carcinoma in situ of bronchus and lung
D02.22 D14.30 - Benign neoplasm of bronchus and lung
D14.32
D45 Polycythemia vera
D56.0 -
D56.9
Thalassemia
D57.00 - Sickle-cell disorders
D57.219
D57.40 -
D57.819
D58.1 -
D58.2
Hereditary elliptocytosis and other
hemoglobinopathies
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Code Code Description
D75.0 -
D75.1
Familial erythrocytosis and secondary
polycythemia
E84.0 -
E84.9
Cystic fibrosis
G44.001 - Cluster headaches
G44.029
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
Pneumonia
J40 - J42 Bronchitis and other chronic obstructive
J44.0 - pulmonary disease
J44.9
J45.20 -
J45.998
Asthma
J47.0 -
J47.9
Bronchiectasis
J84.10 Pulmonary fibrosis, unspecified
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The above policy is based on the following references:
1. Petty TL, O'Donohue WJ Jr. Further recommendations
for prescribing, reimbursement, technology development,
and research in long-term oxygen therapy. Summary of
Code Code Description
P27.0 -
P27.9
Chronic respiratory diseases originating in the
perinatal period
P29.30 - Persistent fetal circulation
P29.38
Q33.4 Congenital bronchiectasis
R00.1 Bradycardia, unspecified
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 - Migraine
G43.919
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]
Dyspnea [without cor pulmonale or evidence of
hypoxemia]
R06.00 -
R06.09
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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan
benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,
general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care
services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors
in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely
responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is
subject to change.
Copyright © 2001-2018 Aetna Inc.
AETNA BETTER HEALTH® OF PENNSYLVANIA
Amendment to Aetna Clinical Policy Bulletin Number:
0002 Oxygen
There are no amendments for Medicaid.
www.aetnabetterhealth.com/pennsylvania Updated 02/14/2018