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Durable Medical Equipment: Respiratory Devices MPM 4.3

Disclaimer Refer to the member’s specific benefit plan and Schedule of

Benefits to determine coverage. This may not be a benefit

on all plans or the plan may have broader or more limited

benefits than those listed in these criteria.

Description Durable Medical Equipment (DME) is equipment which:

• Can withstand repeated use

• Is primarily and customarily used to serve a medical propose

• Generally, is not useful to a person in the absence of illness or injury

• Is appropriate for use in a patient’s home, at school or at work

DME can be rented or purchased, depending on the length of time the member will need the equipment, or if there must be frequent and substantial servicing in order to avoid risk to the patient’s health. The decision whether to rent or purchase DME is made by Presbyterian Health Plan (PHP).

Other related Durable Medical Equipment (DME) medical policies:

• DME for Diabetic Equipment, MPM 4.4

• DME Miscellaneous, MPM 4.5

• DME for Orthotics and Prosthetics, MPM 4.6

• DME for Rehabilitation and Mobility Devices, MPM 4.2

• DME for State Coverage Insurance (SCI), MPM 4.7

This Medical Policy includes the following items:

I - Home Apnea Monitors for Infants

II - Home Oxygen and Oxygen Equipment

III - Oxygen for Cluster Type Migraine Headaches

IV - Portable Oxygen Systems

V - Oximetry Services

VI - Respiratory Assist Devices

VII - Home Ventilator with Noninvasive or Invasive Interfaces:

VIII - Positive Airway Pressure (PAP) Devices for Treatment of

Obstructive Sleep Apnea (OSA)

IX - Concurrent Use of Oxygen with PAP Therapy

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Durable Medical Equipment: Respiratory Devices MPM 4.3

Coverage

Determination

PHP covers Durable Medical Equipment (DME) listed. For ALL

Durable Medical Equipment (DME) listed in this MPM, PHP may or

may not require Prior Authorization. Log on to Pres Online to verify

and/or submit a request: https://ds.phs.org/preslogin/index.jsp

• All item with or without Prior Authorization are subject to retrospective review, and are only covered for the indications listed.

• All Durable Medical Equipment is subject to the limitations and exclusions of the member’s specific benefit plan.

I - Home Apnea Monitors for Infants:

Prior Authorization/Benefit Certification is not required; claims

are subject to retrospective review and are only covered for the

indications listed.

For Commercial members, Presbyterian uses MCG Criteria # A-

0877. Apnea monitors are usually considered medically necessary

until the infant has been episode free for 6 weeks to 3 months; or

when the infant is older than 43 to 44 weeks postmenstrual age

and no events have occurred for several weeks. Due to contractual

restrictions, providers may not access the MCG website but may

obtain a copy of the criteria from the Prior Authorization staff.

For Centennial, PHP follows, NMAC 8.324.5.12.C.(f) for Apnea.

II - Home Oxygen and Oxygen Equipment:

Prior Authorization/Benefit Certification is not required; claims

are subject to retrospective review and are only covered for the

indications listed.

For Medicare and Commercial:

PHP follows LCD L33797 Oxygen and Oxygen Equipment or NCD (240.2) Home Use of Oxygen. Refer also to Policy Article (A52514). Oxygen is covered when medically necessary for use in the home. Coverage of home oxygen therapy requires that the patient be tested in the “chronic stable state” and that all co-existing diseases or conditions that can cause hypoxia must be treated sufficiently. The attending/treating physician has determined that the patient has a severe lung disease or hypoxia-related symptoms that might be expected to improve with oxygen therapy. Refer to the NCD, LCD and LCA policies for additional requirements.

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For Medicaid: PHP follows NMAC Covered Oxygen, DME, NMAC Number 8.324.5 see section 8.324.5.12.C, (8 a-h).

• For Non-covered services, DME, oxygen and medical supplies see: NMAC, 8.324.5.15.C. or 8.301.3.15 NMAC for an overview.

III - Oxygen for Cluster Type Migraine Headaches:

Prior Authorization/Benefit Certification is not required; claims are subject to retrospective review and are only covered for the indications listed.

For Commercial and Centennial members.

PHP follows MCG A-0343 for use of oxygen for treatment of cluster headaches. Individual must be on preventive headache therapy, such as verapamil. Due to contractual restrictions, providers may not access the MCG website but may obtain a copy of the criteria from the Prior Authorization staff.

For Medicare, Commercial and Centennial:

For members enrolled in a clinical trial for cluster headaches, PHP

follows Oxygen and Oxygen Equipment (L33797) for Cluster

Headache. These are for members who are enrolled subjects in

clinical trials approved by CMS and sponsored by the National

Heart, Lung, and Blood Institute (NHLBI Refer also to Policy Article

(A52514).

IV - Portable Oxygen Systems:

Prior Authorization/Benefit Certification is not required; claims are subject to retrospective review and are only covered for the indications listed.

For Medicare, Medicaid and Commercial.

PHP follows LCD (L33797) or NCD (240.2). Refer also to Policy Article (A52514).

A patient meeting the requirements specified below may qualify for coverage of a portable oxygen system either (1) by itself, or, (2) to use in addition to a stationary oxygen system. A portable oxygen system is covered for a particular patient if:

1. mobile within the home, and

2. the qualifying blood gas study was performed only while at rest (awake) or during exercise; but not during sleep.

Relocation and Travel:

PHP follows LCA A52514. See the criteria for Months 1 through 36

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or Months 37 through 60 for details applicable to these months when a patient relocates outside service area (either short-term travel, extended temporary relocation, or permanent relocation).

If a member plans to travel and needs oxygen while away from home, PHP will cover the oxygen if it is arranged for and billed by a participating practitioner/provider. The member should check with their DME supplier to see if this service is available. Oxygen provided by a non-participating practitioner/provider is not a covered benefit.

V - Oximetry Services:

Prior Authorization/Benefit Certification is not required; claims

are subject to retrospective review and are only covered for the

indications listed.

An oximeter is a monitor that measures the oxygen saturation using a non-invasive probe of the blood. Intermittent or short-term pulse oximetry is routinely used for people on long-term oxygen therapy.

For Medicaid, PHP will follow NMAC 8.324.5.D.(2.g) for electronic monitoring device; oxygen saturation.

Note: In addition to CMS LCD coverage mentioned below, PHP covers continuous pulse oximeter for the following:

o Patients on mechanical ventilation

o Infants or children with bronchopulmonary dysplasia

o Premature infants being treated for apnea

For Medicare, Medicaid and Commercial.

PHP follows CMS LCD (L35434) and related article (A57205), Oximetry Services, medically necessary reasons for pulse oximetry to include:

1. Member shows signs or symptoms of acute respiratory dysfunction such as:

a. Tachypnea

b. Dyspnea

c. Cyanosis

d. Respiratory distress

e. Confusion

f. Hypoxia

2. Member has chronic lung disease, severe cardiopulmonary disease or neuromuscular disease involving the muscles of

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respiration, and oximetry is needed for at least one of the following reasons:

a. Initial evaluation to determine the severity of respiratory impairment.

b. Evaluation of an acute change in condition.

c. Evaluation of exercise tolerance in a patient with respiratory disease.

d. Evaluation to establish medical necessity of oxygen therapeutic regimen.

e. Member has sustained severe multiple trauma or complains of acute severe chest pain.

f. Is under treatment with a medication with known pulmonary toxicity, and oximetry is medically necessary to monitor for potential adverse effects of therapy.

3. Overnight Oximetry (94762) is considered medically necessary when used for any of the following circumstances:

a. The patient has a condition for which intermittent arterial blood gas sampling is likely to miss important variations.

b. The patient has a condition resulting in hypoxemia and there is a need to assess supplemental oxygen requirements and/or a therapeutic regimen

See the LCD for other general information such as

• Documentation Requirements

• Utilization Guidelines

• Limitations and

• Place of Services, such as services in home or office.

VI - Respiratory Assist Devices (RAD)

Prior Authorization/Benefit Certification is not required; claims are subject to retrospective review and are only covered for the indications listed.

For Medicare, Medicaid and Commercial.

PHP follows Respiratory Assist Devices, LCD L33800 and related

policy article (A52517) for the use of [Bi-Level Positive Airway

Pressure devices (BiPAP) and Continuous Positive Airway Pressure devices (CPAP)]. Access the LCDs for Definitions and Sleep Test section specific to RAD policy.

The outlined (1-4 section) below is only for the initial coverage (first 3 months) of therapy for those member’s with one of the

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following clinical disorders: restrictive thoracic disorders (i.e., neuromuscular diseases or severe thoracic cage abnormalities), severe chronic obstructive pulmonary disease (COPD), CSA or CompSA, or hypoventilation syndrome. Note: The use of ventilators used to provide CPAP or bi-level CPAP therapy for conditions described above is medical inappropriate, even though the ventilators (E0465 or E0466) equipment may have the capability to operate as bi-level PAP (E0470, E0471) mode. (See section VII below for ventilator used at home).

Note: for those beyond initial coverage for each of the clinical disorder (1-4) mentioned below (see the end of this section titled): **CONTINUED COVERAGE CRITERIA FOR E0470 AND E0471 DEVICES BEYOND THE FIRST THREE MONTHS

For the first three months of therapy, coverage for E0470 or E0471 to be covered, the treating practitioner must fully document in the member’s medical record symptoms characteristic of sleep-associated hypoventilation, such as daytime hypersomnolence, excessive fatigue, morning headache, cognitive dysfunction, dyspnea, etc.

A RAD (E0470, E0471) is covered for those member’s with one of the following clinical disorders:

1. Restrictive Thoracic Disorders: (i.e., neuromuscular diseases or severe thoracic cage abnormalities). Criteria A-C must be met

A. There is documentation regarding neuromuscular disease (for example, amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (for example, post-thoracoplasty for TB).

B. Meet one of the following:

a. An arterial blood gas PaCO2, done while awake and breathing the patient’s prescribed FIO2 is greater than or equal to 45 mm Hg,

or

b. Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for greater than or equal to 5 minutes of nocturnal recording time (minimum recording time of 2 hours), done while breathing the member’s prescribed recommended FIO2,

or

c. For a neuromuscular disease (only), either i or ii,

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i. Maximal inspiratory pressure is less than 60 cm H20,

or

ii. Forced vital capacity is less than 50% predicted

C. Chronic obstructive pulmonary disease does not contribute significantly to the member’s pulmonary limitation.

If all of the above criteria are met, either an E0470 or an E0471 device (based upon the judgment of the treating physician) will be covered for the first three months of therapy.

For use of devices beyond the first 3 months, see below.

2. Severe COPD:

Code E0470 device is covered if criteria A-C are met.

A. An arterial blood gas PaCO2, done while awake and breathing the member’s prescribed FIO2, is greater than or equal to 52 mm Hg.

B. Sleep oximetry demonstrates oxygen saturation less than or equal to 88% for greater than or equal to a cumulative 5 minutes of nocturnal recording time (minimum recording time of 2 hours), done while breathing oxygen at 2 LPM or the members’s prescribed FIO2 (whichever is higher).

C. Prior to initiating therapy, sleep apnea and treatment with a continuous positive airway pressure device (CPAP) has been considered and ruled out. (Note: Formal sleep testing is not required if there is sufficient information in the medical record to demonstrate that the member does not suffer from some form of sleep apnea (Obstructive Sleep Apnea (OSA), CSA and/or CompSA) as the predominant cause of awake hypercapnia or nocturnal arterial oxygen desaturation).

If all of the above criteria for beneficiaries with COPD are met, an E0470 device will be covered for the first three months of therapy.

Respiratory assist device, bi-level pressure (E0471) will be covered for the member with COPD in either of the two situations below, depending on the testing performed to demonstrate the need.

Situation 1. For Group II members (COPD) who qualified for an E0470 device, an E0471 started any time after a period of initial use of an E0470 device is covered if both criteria A and B (below) are met.

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A. An arterial blood gas PaCO2, done while awake and breathing the member’s prescribed FIO2, shows that the member’s PaCO2 worsens greater than or equal to 7 mm HG compared to the original result from criterion A, (above).

B. A facility-based PSG demonstrates oxygen saturation less than or equal to 88% for greater than or equal to a cumulative 5 minutes of nocturnal recording time (minimum recording time of 2 hours) while using an E0470 device that is not caused by obstructive upper airway events – i.e., AHI less than 5. (Refer to the Positive Airway Pressure Devices LCD for information about E0470 coverage for obstructive sleep apnea).

Situation 2. For Group II members (COPD) who qualified for an E0470 device, an E0471 device will be covered if, at a time no sooner than 61 days after initial issue of the E0470 device, both of the following criteria A and B (below) are met:

A. An arterial blood gas PaCO2 is done while awake and breathing the member’s prescribed FIO2, still remains greater than or equal to 52 mm Hg.

B. Sleep oximetry while breathing with the E0470 device, demonstrates oxygen saturation less than or equal to 88% for greater than or equal to a cumulative 5 minutes of nocturnal recording time (minimum recording time of 2 hours), done while breathing oxygen at 2 LPM or the member’s prescribed FIO2 [whichever is higher].

For use of devices beyond the first 3 months, see below.

3. Central Sleep Apnea OR Complex Sleep Apnea (CompSA):

Code E0470 or E0471 device is covered when: prior to initiating therapy, a complete facility-based, attended PSG is performed documenting the following (A and B):

A. The diagnosis of CSA or CompSA;

and

B. Significant improvement of the sleep-associated hypoventilation with the use of an E0470 or E0471 device on the settings that will be prescribed for initial use at home, while breathing the member’s prescribed FIO2.

If all of the above criteria are met, either an E0470 or an E0471 device (based upon the judgment of the treating physician) will be covered for beneficiaries with documented CSA or CompSA for the first three months of therapy.

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For use of devices beyond the first 3 months, see below.

4. Hypoventilation Syndrome:

Code E0470 device and related accessories will be covered if both criteria A and B and either criterion C or D are met.

A. An initial arterial blood gas PaCO2, done while awake and breathing the member’s prescribed FIO2, is greater than or equal to 45 mm Hg

B. Spirometry shows an FEV1/FVC greater than or equal to 70%. (Refer to severe COPD (above) for information about device coverage for members with FEV1/FVC less than 70%.)

C. An arterial blood gas PaCO2, done during sleep or immediately upon awakening, and breathing the patient’s prescribed FIO2, shows the member's PaCO2 worsened greater than or equal to 7 mm HG compared to the original result in criterion A (above).

D. A facility-based PSG or HST demonstrates oxygen saturation less than or equal to 88% for greater than or equal to 5 minutes of nocturnal recording time (minimum recording time of 2 hours) that is not caused by obstructive upper airway events – i.e., AHI less than 5. (Refer to the Positive Airway Pressure Devices LCD for information about E0470 coverage for obstructive sleep apnea.)

Code E0471 RAD device is covered for a member with hypoventilation syndrome if both criteria A, B, and either criterion C or D are met:

A. A covered E0470 device is being used.

B. Spirometry shows an FEV1/FVC greater than or equal to 70%. (Refer to SEVERE COPD (above) for information about device coverage for beneficiaries with FEV1/FVC less than 70%).

C. An arterial blood gas PaCO2, done while awake, and breathing the member’s prescribed FIO2, shows that the member’s PaCO2 worsens greater than or equal to 7 mm HG compared to the ABG result performed to qualify the member for the E0470 device (criterion A under E0470).

D. A facility-based PSG or HST demonstrates oxygen saturation less than or equal 88% for greater than or equal to 5 minutes of nocturnal recording time (minimum recording time of 2 hours) that is not caused by obstructive upper airway events – i.e., AHI less than 5 while using an E0470 device. (Refer to the Positive Airway Pressure

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Devices LCD for information about E0470 coverage for obstructive sleep apnea.)

For use of devices beyond the first 3 months see below.

**For CONTINUED COVERAGE CRITERIA FOR E0470 AND E0471 BEYOND THE FIRST THREE MONTHS:

Members covered for the first three months of an E0470 or an E0471 device must be re-evaluated to establish the medical necessity of continued coverage beyond the first three months. While the member may certainly need to be evaluated at earlier intervals after this therapy is initiated, the re-evaluation upon which PHP will base a decision to continue coverage beyond this time must occur no sooner than 61 days after initiating therapy by the treating physician. PHP will not continue coverage for the fourth and succeeding months of therapy until this re-evaluation has been completed.

There must be documentation in the member’s medical record about the progress of relevant symptoms and member usage of the device up to that time. Failure of the member to be consistently using the E0470 or E0471 device for an average of 4 hours per 24 hour period by the time of the re-evaluation (on or after 61 days after initiation of therapy) would represent non-compliant utilization for the intended purposes and expectations of benefit of this therapy. This would constitute reason for PHP to deny continued coverage as not reasonable and necessary.

A signed and dated statement completed by the treating physician no sooner than 61 days after initiating use of the device, declaring that the member is compliantly using the device (an average of 4 hours per 24 hour period) and that the member is benefiting from its use must be obtained by the supplier of the device for continued coverage beyond three months.

See Respiratory Assist Devices, LCD (L33800) for:

• Refill Requirements

• Replacement Requirements:

• Sleep Tests

VII - Home Ventilator with Noninvasive or Invasive Interfaces:

Prior Authorization/Benefit Certification is not required; claims are subject to retrospective review and are only covered for the indications listed.

For Medicare, Medicaid and Commercial.

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PHP follows Respiratory Assist Devices LCD L33800 with related article A52517, and NCD 280.1 for Home Ventilators. Codes (E0465, E0466 & E0467) home ventilator either invasive interface (e.g., tracheostomy tube) or non-invasive interface (e.g., mask, chest shell) are covered for treatment of the following conditions: neuromuscular diseases; thoracic restrictive diseases; and chronic respiratory failure consequent to chronic obstructive pulmonary disease. Access LCD L33800 and LCA A52517 for important details to help determine the use of a ventilator versus a bi-level PAP device.

VIII - Positive Airway Pressure (PAP) Devices for Treatment of Obstructive Sleep Apnea (OSA):

Prior Authorization/Benefit Certification is not required; claims are subject to retrospective review and are only covered for the indications listed.

For Medicare, Medicaid and Commercial.

PHP follows CMS LCD L33718 Positive Airway Pressure Devices for the Treatment of Obstructive Sleep Apnea and related policy

article (A52467). LCD L33718 contains criteria for CPAP and

BiPAP coverage, as well as information on the sleep tests required to qualify for a respiratory assist device, requirements for continuing coverage of CPAP/BiPAP and physician qualifications.

Initial Coverage:

In this policy, the term PAP (positive airway pressure) device will refer to both a single-level continuous positive airway pressure device (E0601) and a bi-level respiratory assist device without back-up rate (E0470) when it is used in the treatment of obstructive sleep apnea.

I. An E0601 CPAP device is covered for the treatment of obstructive sleep apnea (OSA) if criteria A–C are met:

A. The member has a face-to-face clinical evaluation by the treating practitioner prior to the sleep test to assess the member for obstructive sleep apnea.

B. The member has a sleep test (as defined below) that meets either of the following criteria (1 or 2):

1. The apnea-hypopnea index (AHI) or Respiratory Disturbance Index (RDI) is greater than or equal to 15 events per hour with a minimum of 30 events; or

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2. The AHI or RDI is greater than or equal to 5 and less than or equal to 14 events per hour with a minimum of 10 events and documentation of:

a. Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or

b. Hypertension, ischemic heart disease, or history of stroke.

C. The member and/or their caregiver has received instruction from the supplier of the device in the proper use and care of the equipment.

II. Code E0470 RAD device is covered for those members with OSA who meet criteria A-C above, in addition to criterion D below:

D. CPAP (E0601) has been tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting.

Ineffective is defined as documented failure to meet therapeutic goals using an E0601 during the titration portion of a facility-based study or during home use despite optimal therapy (i.e., proper mask selection and fitting and appropriate pressure settings).

If E0470 is billed for a member with OSA and criteria A-D are not met, it will be denied as not reasonable and necessary.

If an E0601 device is tried and found ineffective during the initial facility-based titration or home trial, substitution of an E0470 does not require a new initial face-to-face clinical evaluation or a new sleep test.

Exclusion:

A Bi-Level Positive Airway Pressure devices (BiPAP)- A bi-level positive airway pressure device with back-up rate (E0471) is not reasonable and necessary if the primary diagnosis is OSA. If an E0471 is billed with a diagnosis of OSA, it will be denied as not reasonable and necessary

If an E0601 device has been used for more than 3 months and the member is switched to an E0470, a new initial face-to-face clinical evaluation is required, but a new sleep test is not required. A new 3-month trial would begin for use of the E0470.

CONTINUED COVERAGE CRITERIA BEYOND THE FIRST THREE MONTHS for PAP:

Must occur no sooner than the 31st day but no later than the 91st day after initiating therapy, the treating practitioner must

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conduct a clinical re-evaluation and document that the member is benefiting from PAP therapy

Documentation of clinical benefit is demonstrated by:

1. Face-to-face clinical re-evaluation by the treating practitioner with documentation that symptoms of obstructive sleep apnea are improved; and

2. Objective evidence of adherence to use of the PAP device, reviewed by the treating practitioner.

If the practitioner re-evaluation does not occur until after the 91st

day but the evaluation demonstrates that the member is benefiting

from PAP therapy as defined in criteria 1 and 2 above, continued

coverage of the PAP device will commence with the date of that re-

evaluation.

Beneficiaries who fail the initial 12 week trial are eligible to re-

qualify for a PAP device but must have both:

1. Face-to-face clinical re-evaluation by the treating practitioner to determine the etiology of the failure to respond to PAP therapy; and

2. Repeat sleep test in a facility-based setting (Type 1 study). This may be a repeat diagnostic, titration or split-night study.

Ineffective usage following initiation of CPAP (E0601):

If an E0601 device is tried and found ineffective during the initial facility-based titration or home trial, substitution of an E0470 does not change the length of the trial unless there is less than 30 days remaining in the trial period. If more than 30 days remain in the trial period, the clinical re-evaluation would still occur between the 31st and 91st day following the initiation of an E0601 and objective documentation of adherence on the E0470 would need to occur prior to the 91st day following initiation of the E0601. If less than 30 days remain in the trial period, the clinical re-evaluation and objective documentation of adherence must occur before the 120th day following the initiation of the E0601.

If an E0601 device was used for more than 3 months and the member was then switched to an E0470, the clinical re-evaluation must occur between the 31st and 91st day following the initiation of the E0470. There would also need to be documentation of adherence to therapy during the 3-month trial with the E0470.

Please refer to LCD (L33718) for additional requirements on the below topics for RAD:

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• Refill Requirements:

• Replacement Requirements: Information for E0470 or E0471 RAD device is replaced during the 5 year or replaced following the 5 year reasonable useful lifetime (RUL).

• Sleep Test Requirements:

IX - Concurrent Use of Oxygen with PAP Therapy:

Prior Authorization is not required.

Coverage is for Medicare, Centennial and Commercial.

PHP follows Oxygen and Oxygen Equipment, LCD (L33797) refer also to Policy Article (A52514); or Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea, LCD (L33718).

Coverage of home oxygen therapy requires that the member be tested in the “chronic stable state”, and not during a period of acute illness or an exacerbation of their underlying disease. All co-existing diseases or conditions that can cause hypoxia must be treated and the member must be in a chronic stable state before oxygen therapy is considered eligible.

In addition, the beneficiary must have a severe lung disease, such as chronic obstructive pulmonary disease, diffuse interstitial lung disease, cystic fibrosis, bronchiectasis, widespread pulmonary neoplasm, or hypoxia-related symptoms or findings that might be expected to improve with oxygen therapy.

For members with OSA to be considered in the chronic, stable state, OSA must be sufficiently treated such that the underlying severe lung disease is unmasked. This must be demonstrated before oxygen saturation results obtained during polysomnography are considered qualifying for oxygen therapy.

For members with OSA, a qualifying oxygen saturation test may only occur during a titration polysomnographic study (either split night or stand-alone). The titration PSG is one in which all of the following criteria are met:

1. The titration is conducted over a minimum of two (2) hours; and

2. During titration: a. The AHI/RDI is reduced to less than or equal to an

average of ten (10) events per hour; or b. If the initial AHI/RDI was less than an average of ten (10)

events per hour, the titration demonstrates further reduction in the AHI/RDI; and

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3. Nocturnal oximetry conducted for the purpose for oxygen reimbursement qualification may only be performed after optimal PAP settings have been determined and the member is using the PAP device at those settings; and

4. The nocturnal oximetry conducted during the PSG demonstrates an oxygen saturation ≤ 88% for 5 minutes total (which need not be continuous)

Overnight oximetry performed as part of home sleep testing or as part of any other home testing is not considered.

Exclusions 1. Oxygen provided by a non-participating practitioner/provider is not a covered benefit.

2. Unattended home sleep monitoring is not covered for any indication other than obstructive sleep apnea (OSA).

3. Comfort and convenience items generally are not covered and include but are not limited to:

• Vaporizers

• Humidifiers (if not part of respiratory assist devices)

• Items that are precautionary in nature, such as spare tanks of oxygen in addition to portable backup systems.

4. Upgraded or deluxe items, or duplicate items (i.e., for home, office or car).

Definition Durable Medical Equipment (DME): Items that are reusable and provide support for physical limitations and disabilities, can withstand repeated use, and are used for a medical purpose, in the member’s residence (excluding a skilled nursing facility or acute care hospital) under a physician’s supervision.

Items requiring frequent and substantial servicing (rental only): Items for which there must be frequent and substantial servicing in order to avoid risk to the patient’s health. Examples of these items include ventilators, aspirators, IPPB machines, passive motion exercise devices, etc. Items in this category may be rented for as long as the patient’s need continues.

Reasonable Useful Lifetime: In the absence of Medicare Program Instructions, the Reasonable Useful Lifetime can be determined by the member’s individual plan, but in no case can it be less than 5 years. Computation of the useful lifetime is based on when the equipment was delivered to the member, not the age of the equipment. If the equipment remains in good working order and meets the member’s medical needs, it should not be automatically replaced.

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Apnea-Hypopnea Index (AHI): The number of episodes of apnea and hypopnea per hour. If the AHI or RDI is calculated based on less than two hours of continuous recorded sleep, the total number of recorded events to calculate the AHI or RDI during sleep testing is at least the number of events that would have been required in a two hour period.

Respiratory Distress Index (RDI): The average number of respiratory disturbances per hour.

Diagnostic tests for obstructive sleep apnea:

• Type I: attended, in-facility polysomnogram.

• Type II: portable monitor (used in both attended and unattended setting) with a minimum of 7 channels, monitoring EEG, EOG (electro-oculogram), EMG (electromyelogram), EKG-heart rate, airflow, respiratory effort, oxygen saturation. A Type II device monitors sleep staging, so AHI can be calculated.

• Type III: portable monitor (used in both attended and unattended setting) with a minimum of four monitored channels including ventilation or airflow (at least two channels of respiratory movement or respiratory movement and airflow), heart rate or EKG, and oxygen saturation.

• Type IV: portable monitors which measure one, two or three parameters but do not meet all the criteria of a higher level device. Type IV monitors are used in both attended and unattended setting. To meet CMS guidelines, a Type IV portable monitor should measure at least three channels, one of which is airflow.

• Another type of sleep testing device, which does not fit into the classifications, noted above, measures three or more channels that include actigraphy, oximetry and peripheral arterial tone. This test is also covered by CMS for members who have signs and symptoms of obstructive sleep apnea.

Coding The coding listed in this medical policy is for reference

only. Covered and non-covered codes are within this list.

HCPCS for Home Apnea Monitors for Infants

HCPCS Codes DME: Pediatric Home Apnea Monitors description

A4556 Electrodes, per pair

A4557 Lead wires, per pair

E0618 Apnea monitor, without recording feature

Medical Policy Original Effective Date: April 1999

Revised Date: 11-18-2020 Page 17 of 23

Durable Medical Equipment: Respiratory Devices MPM 4.3

HCPCS Codes DME: Pediatric Home Apnea Monitors description

E0619 Apnea monitor, with recording feature

HCPCS for Oxygen Equipment

HCPCS Code Oxygen and Oxygen Equipment/ Accessories for LCD (L33797) & LCA (A52514)

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 contents 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, & tubing

E0440 Stationary liquid oxygen system, purchase; includes use of reservoir, contents indicator, regulator, flowmeter, humidifier, nebulizer, cannula or mask, and tubing

E0441 Stationary oxygen contents, gaseous, 1 month's supply = 1 unit

E0442 Stationary oxygen contents, liquid, 1 month's supply = 1 unit

E0443 Portable oxygen contents, gaseous, 1 month's supply = 1 unit

E0444 Portable oxygen contents, liquid, 1 month's supply = 1 unit

E0445 Oximeter device for measuring blood oxygen levels non-invasively

E0446 Topical oxygen delivery system, not otherwise specified, includes all supplies and accessories

E0447 Portable oxygen contents, liquid, 1 month's supply = 1 unit, prescribed amount at rest or nighttime exceeds 4 liters per minute (lpm)

E0467

Home ventilator, multi-function respiratory device, also performs any or all of the additional functions of oxygen concentration, drug nebulization, aspiration, and cough stimulation, includes all accessories, components and supplies for all functions. (E0447, E1405, and E1406 to HCPCS codes included in E0467)

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,

Medical Policy Original Effective Date: April 1999

Revised Date: 11-18-2020 Page 18 of 23

Durable Medical Equipment: Respiratory Devices MPM 4.3

HCPCS Code Oxygen and Oxygen Equipment/ Accessories for LCD (L33797) & LCA (A52514)

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

K0739 Repair or nonroutine service for durable medical equipment other than oxygen equipment requiring the skill of a technician, labor component, per 15 minutes

A4575 Topical hyperbaric oxygen chamber, disposable

A4606 Oxygen probe for use with oximeter device, replacement

A4608 Transtracheal oxygen catheter, each

A4615 Cannula, nasal

A4616 Tubing (oxygen), per foot

A4617 Mouth piece

A4619 Face tent

A4620 Variable concentration mask

A7525 Tracheostomy mask, each

A9900 Miscellaneous dme supply, accessory, and/or service component of another hcpcs code

E0455 Oxygen tent, excluding croup or pediatric tents

E0555 Humidifier, durable, glass or autoclavable plastic bottle type, for use with regulator or flowmeter

E0580 Nebulizer, durable, glass or autoclavable plastic, bottle type, for use with regulator or flowmeter

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

CPT Codes CPT- for Oximetry Services for LCD (L35434)

94760 Noninvasive ear or pulse oximetry for oxygen saturation; single determination

94761 Noninvasive ear or pulse oximetry for oxygen saturation; multiple determinations

Medical Policy Original Effective Date: April 1999

Revised Date: 11-18-2020 Page 19 of 23

Durable Medical Equipment: Respiratory Devices MPM 4.3

CPT Codes CPT- for Oximetry Services for LCD (L35434)

94762 Noninvasive ear or pulse oximetry for oxygen saturation, by continuous overnight monitoring (separate procedure)

For ICD -10 codes that support medical necessity for Oximetry Services, see related LCA (A57205)

HCPCS Codes Respiratory Assist Devices LCD (L33800) related article (A52517) And Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718), related article (A52467)

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)

E0601 Continuous positive airway pressure (CPAP) device

A4604 Tubing with integrated heating element for use with positive airway pressure device. **1 per 3 months

A7027 Combination oral/nasal mask, used with continuous positive airway pressure device, each. **1 per 3 months

A7028 Oral cushion for combination oral/nasal mask, replacement only, each. **2 per 1 month

A7029 Nasal pillows for combination oral/nasal mask, replacement only, pair. **2 per 1 month

A7030 Full face mask used with positive airway pressure device, each. **1 per 3 months

A7031 Face mask interface, replacement for full face mask, each. **1 per 1 month

A7032 Cushion for use on nasal mask interface, replacement only, each. **2 per 1 month

A7033 Pillow for use on nasal cannula type interface, replacement only, pair. **2 per 1 month

A7034 Nasal interface (mask or cannula type) used with positive airway pressure device, with or without head strap. **1 per 3 months

A7035 Headgear used with positive airway pressure device. **1 per 6 months

A7036 Chinstrap used with positive airway pressure device. **1 per 6 months

A7037 Tubing used with positive airway pressure device. **1 per 3 months

A7038 Filter, disposable, used with positive airway pressure device. **2 per 1 month

A7039 Filter, non disposable, used with positive airway pressure device. **1 per 6 months

A7044 Oral interface used with positive airway pressure device, each

A7045 Exhalation port with or without swivel used with accessories for positive airway devices, replacement only

Medical Policy Original Effective Date: April 1999

Revised Date: 11-18-2020 Page 20 of 23

Durable Medical Equipment: Respiratory Devices MPM 4.3

HCPCS Codes Respiratory Assist Devices LCD (L33800) related article (A52517) And Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718), related article (A52467)

A7046 Water chamber for humidifier, used with positive airway pressure device, replacement, each. **1 per 6 months

E0561 Humidifier, non-heated, used with positive airway pressure device

E0562 Humidifier, heated, used with positive airway pressure device

E0465 Home ventilator, any type, used with invasive interface, (e.g., tracheostomy tube)

E0466 Home ventilator, any type, used with noninvasive interface, (e.g., mask, chest shell)

E0467

Home ventilator, multi-function respiratory device, also performs any or all of the additional functions of oxygen concentration, drug nebulization, aspiration, and cough stimulation, includes all accessories, components and supplies for all functions

For coding instruction for Respiratory Assist Devices, see related policy LCA (A52517). See also Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep

Apnea (A52467).

References

1. Medicare NCD Manual, Chapter 1, Part 4 (Sections 200 – 310.1) Coverage Determination for: 240.2 Home Use of OXYGEN; 240.2.1 Home Use of Oxygen in Approved Clinical Trails; 240.2.2 Home Oxygen Use to Treat Cluster Headache; 240.4 CPAP Therapy for OSA; 240.4.1 Sleep Testing for OSA. Revision #198 on 06/29/2017. Accessed 11-06-2020

a. NCD for Home Oxygen Use to Treat Cluster Headache (240.2.2).

b. NCD for Home Use of Oxygen in Approved Clinical Trials (240.2.1).

2. Medicare Benefit Policy Manual Chapter 15, Covered Medical and Other Health Services, see section 110.1 Definition of Durable Medical Equipment; 110.2 Repairs, Maintenance, Replacement, and Delivery; 110.3 Revision # 259 on 07-12-19. Accessed 11-06-2020.

3. CMS, LCD for OXIMETRY Services (L35434), Revision #5, effective Date: 10/17/2019. Accessed 11-06-2020

4. New Mexico Human Services Department, Medical Assistance Division Program Policy Manual, Durable Medical Equipment, Oxygen and Medical Supplies, Prosthetics and Orthotics, Effective 1-1-14. For New Mexico Covered/Non-Covered Durable Medical Equipment, NMAC Number 8.324.5 see section outlined.

a. 8.324.5.12 Covered Services:

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Durable Medical Equipment: Respiratory Devices MPM 4.3

b. 8.324.5.13 Utilization Review and Prior Authorization: See section D: Prior Authorization for specific services (1-3) for listings. –

c. 8.324.5.15 Non Covered Services

5. New Mexico Human Services Department, Medical Assistance Division Program Policy Manual. General Non-covered Services, NMAC 8.301.3.15., Accessed 11-06-2020

6. Celerian Group Company (CGS), Government Services. Durable Medical Equipment Medicare Administrative Contractor (DME MAC A55426), Standard Documentation Requirements for All Claims Submitted to DME MACs for Jurisdiction C, Updated Date: 06/12/2018. Accessed on the Internet 11-06-2020.

7. CMS, Medicare Benefit Policy Manual, Chapter 15, 110 Durable Medical Equipment – General. Rev. 259, on 07-12-2019. Accessed 11-06-2020.

8. Centers for Medicare and Medicaid Service. Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA), NCD (240.4), Version Number 4, Effective date: 03-13-08. Accessed 11-06-2020.

9. CGS DME MAC J-C, Local Coverage Determination L33718 Positive Airway Pressure Devices for the Treatment of Obstructive Sleep Apnea. Revision History Date 01/01/2020, R7, related article A52467 Accessed 11/05/2020.

10. CGS, DME MAC J-C, Respiratory Assist Devices, LCD L33800, Revision History Date 01-01-2020, Revision Number 7. Related article: A52517, Revision date 04-03-2020, R11. Accessed 11-16-2020

11. CMS, National Coverage Determination Manual, Durable Medical Equipment Reference List, Pub. 100-03 in Chapter 1, Part 4, Section 280.1. Rev. 198, 06/27/2017. [Cited 11-06-2020]

12. MCG, Home Apnea Monitor. ACG: A-0877, Last updated 02/11/2019. [Cited 11-06-2020]

13. MCG, Oxygen Therapy, Continuous and Non-Continuous: Home (DME). ACG: A-0343 (AC), Last Update: 02-09-19. Accessed 11-06-2020.

14. MCG, Apnea, Neonatal (Non-Term Infants), ORG: P-15 (ISC). Last Update: 06-24-2020. Accessed 11-06-2020.

15. CGS Celerian Group Company, DME Oxygen and Oxygen Equipment, LCD (L33797) – Revision Effective Date: 08-02-

Medical Policy Original Effective Date: April 1999

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Durable Medical Equipment: Respiratory Devices MPM 4.3

2020, #R7. For ICD-10 code, refer to Covered ICD-10 codes in the LCD-related Policy Article (A52514). Accessed 11-05-2020

Approval Signatures Clinical Quality & Utilization Mgmt. Committee: Howard Epstein MD

Medical Directory: Norman White MD

Date Approved November 18, 2020

Publications History 06-23-10 Annual Review and Revision

08-24-11 Annual Review and Revision

01-29-14 Annual Review

09-28-16 Annual Review

11-28-18 Annual Review

09-25-19 Annual Review to update HCPCS and diagnosis. Included Home Ventilator with Noninvasive or Invasive Interfaces from LCD L33800; also added Concurrent Use of Oxygen with PAP Therapy using both LCD L33718 and L33797. Updated all hyperlinks to all LCDs.

11-18-20 Annual Review. Reviewed by PHP Medical Policy Committee, review completed on 12/09/2020. The following 9 items were reviewed. All links were updated for each item; and each item were updated for which product lines were covered and all items will continue to not require prior authorization.

Home Apnea Monitors for Infants: No longer required to request a PA if the Apnea monitor is needed for additional 6 months. Commercial continue to follow MCG A-0877 and Centennial continues to follow NMAC 8.324.5.12.C.(f).

Home Oxygen and Oxygen Equipment: PHP continues to follow LCD L33797 and NCD (240.2) for Medicare and Commercial and Medicaid continues to follow NMAC Number 8.324.5

Oxygen for Cluster Type Migraine Headaches: Commercial and Centennial members will now follow MCG A-0343. The old criteria removed and replaced. The use of oxygen for treatment of cluster headache member must be on preventive headache therapy, such as verapamil. Also, participation in the clinical trial for cluster HA will now be for Commercial and Centennial, not just for Medicare members; and will continue to follow LCD (L33797).

Portable Oxygen Systems:

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Durable Medical Equipment: Respiratory Devices MPM 4.3

Continue to follow LCD (L33797) or NCD (240.2) for all LOB. Relocation and Travel will continue to follow LCA A52514. Added two additional codes E0467 and K0739

Oximetry Services: Continue to follow CMS LCD (L35434) and A57205 for all LOBs. Add that electronic monitoring device and oxygen saturation, is for Medicaid only and will follow NMAC 8.324.5.13.D.(2g)

Respiratory Assist Devices: Continue to follow Respiratory Assist Devices LCD L33800 for all LOB.

Home Ventilator with noninvasive or invasive Interfaces: Continue to follow NCD 280.1 and/or LCD L33800 for Ventilators for all LOB. Added home ventilator codes E0465 and E0466.

Positive Airway Pressure (PAP) Devices for Treatment of OSA Continue to follow LCD L33718 for PAP for all LOBs.

Concurrent Use of Oxygen with Pap Therapy: Continue to follow LCD - L33797 or L33718 (which are identical) for all LOB.

This Medical Policy is intended to represent clinical guidelines describing medical appropriateness and is developed to assist Presbyterian Health Plan and Presbyterian Insurance Company, Inc. (Presbyterian) Health Services staff and Presbyterian medical directors in determination of coverage. The Medical Policy is not a treatment guide and should not be used as such.

For those instances where a member does not meet the criteria described in these guidelines, additional information supporting medical necessity is welcome and may be utilized by the medical director in reviewing the case. Please note that all Presbyterian Medical Policies are available online at: Click here for Medical Polices