Respiratory Assist Devices

Policy ID: E-34-025

Section: Durable Medical Equipment

Effective Date: July 01, 2018

Revised Date: September 29, 2020

Revision Effective Date: November 02, 2020

Last Reviewed: September 21, 2020

Description

A noninvasive positive pressure respiratory assistance (NPPRA) is the administration of positive air pressure, using a nasal and/or oral mask interface which creates a seal, avoiding the use of more invasive airway access (e.g. tracheostomy).

A respiratory assist device (RAD) without backup rate delivers adjustable, variable levels (within a single respiratory cycle) of positive air pressure by way of tubing and a noninvasive interface (such as a nasal or oral facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs.

A RAD with backup rate delivers adjustable, variable levels (within a single respiratory cycle) of positive air pressure by way of tubing and a noninvasive interface (such as a nasal or oral facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs.

Criteria

A RAD may be considered medically necessary for the first three (3) months of therapy for individuals with Restrictive Thoracic Disorders that meet the following criteria:

Individual has presence of a neuromuscular disease (e.g., amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (e.g., post-thoracoplasty for TB); and
- An arterial blood gas PaCO2, done while awake and breathing the individual's prescribed FIO2, is greater than or equal to 45 mm Hg; or
- Sleep oximetry demonstrates oxygen saturation level is equal to or less than 88% for at least five (5) minutes, done while breathing the individual's prescribed fractional concentration of oxygen delivered for inspiration (FIO2); or
Individual has presence of neuromuscular disease (only):
- Maximal inspiratory pressure is less than 60 cm H2O or forced vital capacity is less than 50% predicted; and
- Chronic obstructive pulmonary disease (COPD) does not contribute significantly to the individual's pulmonary limitation.

Procedure Codes

E0470

E0471

E0472

A RAD may be considered medically necessary for the first three (3) months of therapy for individuals with severe COPD that meet ALL of the following criteria:

An arterial blood gas PaCO2, done while awake and breathing the individual's prescribed FIO2, is equal to or greater than 52 mm Hg; and
Sleep oximetry demonstrates oxygen saturation level equal to or less than 88% for at least five (5) minutes, done while breathing oxygen at two (2) liters per minute (LPM) or the individual's prescribed FIO2, whichever is higher; and
Prior to initiating therapy, obstructive sleep apnea (OSA) and treatment with continuous positive airway pressure (CPAP) has been considered and ruled out.

A RAD with backup rate device will be considered not medically necessary for an individual with COPD during the first two (2) months.

Note: Therapy with a RAD without back-up device with proper adjustments of the settings, and individual accommodation to its use, will usually result in sufficient improvement without need of a back-up rate.

A RAD with back-up device may be considered medically necessary when the following criteria have been met:

The individual has used an RAD without back-up for sixty-one (61) days; and
An arterial blood gas PaCO2 is repeated while the individual is awake and breathing their prescribed FIO2 and the level remains 52 mm Hg; and
A sleep oximetry, while the individual is breathing with the RAD without back-up device demonstrates O2 saturation of less than 88% for at least five (5) continuous minutes, done while breathing oxygen at two (2) LPM or the individual's prescribed FIO2, whichever is higher.

A RAD may be considered medically necessary for the first three (3) months of therapy for those individuals with central sleep apnea (CSA) that have had an attended polysomnogram, performed on stationary equipment and meet ALL of the following criteria:

The diagnosis of CSA; and
The exclusion of obstructive sleep apnea (OSA) as the predominant cause of sleep-associated hypoventilation; and
The ruling out of CPAP as effective therapy if OSA is a component of the sleep-associated hypoventilation; and
Significant improvement of the sleep-associated hypoventilation with the use of either RAD device on the settings that will be prescribed for initial use at home, while breathing the individual's prescribed FIO2.

Procedure Codes

A4604	A7027	A7028	A7029	A7030	A7031	A7032
A7033	A7034	A7035	A7036	A7037	A7038	A7039
A7044	A7045	A7046	E0470	E0471	E0472	S8186

Heated and non-heated humidification may be considered medically necessary when prescribed by the treating physician to meet the needs of the individual and when the RAD meets the above criteria.

Procedure Codes

E0561

E0562

Non-invasive Open Ventilation (NIOV) System

Non-invasive open ventilation (NIOV) system is considered experimental/investigational and therefore non-covered. The safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Procedure Code

E1399

If the above criteria are not met, the device and related accessories (see Table below) are considered not medically necessary.

For coverage beyond the initial three (3) months of therapy, medical necessity of continued coverage of these devices must occur within 61 to 90 days from the date the therapy was initiated.

Quantities of supplies greater than those identified, as the usual maximum amounts are considered not medically necessary.

A physician must prescribe ALL equipment and accessory durable medical equipment.

See below for accessory quantity level limits.

Accessory	Usual Maximum Replacement
A4604**	1 per 3 months
A7027**	1 per 3 months
A7028**	2 per 1 month
A7029**	2 per 1 month
A7030**	1 per 3 months
A7031**	1 per 1 month
A7032**	2 per 1 month
A7033**	2 per 1 month
A7034**	1 per 3 months
A7035*	1 per 6 months
A7036*	1 per 6 months
A7037**	1 per 3 months
A7038**	2 per 1 month
A7039*	1 per 6 months
A7044*	1 per 3 months
A7045*	1 per 3 months
A7046*	1 per 6 months

* Allows for a 10 day delivery before run-out

** Allowing for a 3 month supply

For the purpose of this policy, arterial blood gas, sleep oximetry, and polysomnographic studies may not be performed by a DME supplier. A DME supplier is not considered a qualified provider or supplier of these tests for purposes of this policy's coverage and payment guidelines. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

Refer to Medical Policy Devices Used for the Treatment of Sleep Apnea in Adults for additional information.

Diagnosis Codes

Covered Diagnosis Codes for Procedure codes: E0470, E0471, E0472

E66.2	G12.0	G12.1	G12.20	G12.21	G12.22	G12.29
G12.8	G12.9	G35	G47.31	G47.32	G47.34	G47.35
G47.36	G47.37	G61.0	M41.00	M41.02	M41.03	M41.04
M41.05	M41.06	M41.07	M41.08	M41.112	M41.113	M41.114
M41.115	M41.116	M41.117	M41.119	M41.122	M41.123	M41.124
M41.125	M41.126	M41.127	M41.20	M41.22	M41.23	M41.24
M41.25	M41.26	M41.27	M41.30	M41.34	M41.35	M41.40
M41.41	M41.42	M41.43	M41.44	M41.45	M41.46	M41.47
Q31.0	Q31.1	Q31.2	Q31.5	Q31.8	Q31.9	Q32.0
Q32.1	Q32.2	Q32.3	Q32.4

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 9-21-2020 Coding update-Adding Procedure code E0472

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.

Section: Durable Medical Equipment

Effective Date: July 01, 2018

Revised Date: June 04, 2019

Last Reviewed: June 04, 2019

Archived Date: September 30, 2020

Description

A non-invasive positive pressure respiratory assistance (NPPRA) is the administration of positive air pressure, using a nasal and/or oral mask interface which creates a seal, avoiding the use of more invasive airway access (e.g., tracheostomy).

A respiratory assist device (RAD) without backup rate delivers adjustable, variable levels (within a single respiratory cycle) of positive air pressure by way of tubing and a non-invasive interface (such as a nasal or oral facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs.

A RAD with backup rate delivers adjustable, variable levels (within a single respiratory cycle) of positive air pressure by way of tubing and a non-invasive interface (such as a nasal or oral facial mask) to assist spontaneous respiratory efforts and supplement the volume of inspired air into the lungs.

Criteria

A RAD may be considered medically necessary for the first three (3) months of therapy for individuals with Restrictive Thoracic Disorders that meet the following criteria:

Individual has presence of a neuromuscular disease (e.g., amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (e.g., post-thoracoplasty for TB); and
- 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
- Sleep oximetry demonstrates oxygen saturation level is equal to or less than 88% for at least five (5) minutes, done while breathing the patient’s prescribed fractional concentration of oxygen delivered for inspiration (FIO2); or
Individual has presence of neuromuscular disease (only):
- Maximal inspiratory pressure is less than 60 cm H2O or forced vital capacity is less than 50% predicted; and
- Chronic obstructive pulmonary disease (COPD) does not contribute significantly to the patient’s pulmonary limitation.

Procedure Codes

E0470

E0471

A RAD may be considered medically necessary for the first three (3) months of therapy for individuals with severe COPD that meet ALL of the following criteria:

An arterial blood gas PaCO2, done while awake and breathing the individual’s prescribed FIO2, is equal to or greater than 52 mm Hg; and
Sleep oximetry demonstrates oxygen saturation level equal to or less than 88% for at least five (5) minutes, done while breathing oxygen at two (2) liters per minute (LPM) or the patient’s prescribed FIO2, whichever is higher; and
Prior to initiating therapy, obstructive sleep apnea (OSA) and treatment with continuous positive airway pressure (CPAP) has been considered and ruled out.

If a RAD with backup rate is billed, but the criteria for a RAD without backup rate device are met, payment will be based on the RAD without backup rate.

A RAD with backup rate device will be considered not medically necessary for an individual with COPD during the first two (2) months.

Note: Therapy with a RAD without back-up device with proper adjustments of the settings, and individual accommodation to its use, will usually result in sufficient improvement without need of a back-up rate.

A RAD with back-up device may be considered medically necessary when the following criteria have been met:

The individual has used an RAD without back-up for sixty-one (61) days; and
An arterial blood gas PaCO2 is repeated while the individual is awake and breathing their prescribed FIO2 and the level remains 52 mm Hg; and
A sleep oximetry, while the individual is breathing with the RAD without back-up device demonstrates O2 saturation of less than 88% for at least five (5) continuous minutes, done while breathing oxygen at two (2) LPM or the individual’s prescribed FIO2, whichever is higher.

Procedure Codes

A4604	A7027	A7028	A7029	A7030	A7031	A7032
A7033	A7034	A7035	A7036	A7037	A7038	A7039
A7046	A7044	S8186	A7045	E0470	E0471

The diagnosis of CSA; and
The exclusion of obstructive sleep apnea (OSA) as the predominant cause of sleep-associated hypoventilation; and
The ruling out of CPAP as effective therapy if OSA is a component of the sleep-associated hypoventilation; and
Significant improvement of the sleep-associated hypoventilation with the use of either RAD device on the settings that will be prescribed for initial use at home, while breathing the patient’s prescribed FIO2.

Procedure Codes

A4604	A7027	A7028	A7029	A7030	A7031	A7032
A7033	A7034	A7035	A7036	A7037	A7038	A7039
A7046	A7044	S8186	A7045	E0470	E0471

Heated and non-heated humidification may be considered medically necessary when prescribed by the treating physician to meet the needs of the individual and when the RAD meets the above criteria.

Procedure Codes

E0561

E0562

Non-invasive Open Ventilation (NIOV) System

Procedure Code

E1399

If the above criteria are not met, the device and related accessories (see Table below) are considered not medically necessary.

For coverage beyond the initial three (3) months of therapy, medical necessity of continued coverage of these devices must occur within 61 to 90 days from the date the therapy was initiated.

Quantities of supplies greater than those identified, as the usual maximum amounts are considered not medically necessary.

A physician must prescribe ALL equipment and accessory durable medical equipment.

See below for accessory quantity level limits.

Accessory	Usual Maximum Replacement
A4604**	1 per 3 months
A7027**	1 per 3 months
A7028**	2 per 1 month
A7029**	2 per 1 month
A7030**	1 per 3 months
A7031**	1 per 1 month
A7032**	2 per 1 month
A7033**	2 per 1 month
A7034**	1 per 3 months
A7035*	1 per 6 months
A7036*	1 per 6 months
A7037**	1 per 3 months
A7038**	2 per 1 month
A7039*	1 per 6 months
A7044*	1 per 3 months
A7045*	1 per 3 months
A7046*	1 per 6 months

* Allows for a 10 day delivery before run-out

** Allowing for a 3 month supply

Total payments for a rental items may not exceed its allowable purchase price, except for those items identified as life-sustaining DME.

For the purpose of this policy, arterial blood gas, sleep oximetry, and polysomnographic studies may not be performed by a DME supplier. A DME supplier is not considered a qualified provider or supplier of these tests for purposes of this policy’s coverage and payment guidelines. This prohibition does not extend to the results of studies conducted by hospitals certified to do such tests.

Refer to Medical Policy Devices Used for the Treatment of Sleep Apnea in Adults for additional information.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes E0470 and E0471

E66.2	G12.0	G12.1	G12.20	G12.21	G12.22	G12.29
G12.8	G12.9	G35	G47.31	G47.32	G47.34	G47.35
G47.36	G47.37	G61.0	M41.00	M41.02	M41.03	M41.04
M41.05	M41.06	M41.07	M41.08	M41.112	M41.113	M41.114
M41.115	M41.116	M41.117	M41.119	M41.122	M41.123	M41.124
M41.125	M41.126	M41.127	M41.20	M41.22	M41.23	M41.24
M41.25	M41.26	M41.27	M41.30	M41.34	M41.35	M41.40
M41.41	M41.42	M41.43	M41.44	M41.45	M41.46	M41.47
Q31.0	Q31.1	Q31.2	Q31.5	Q31.8	Q31.9	Q32.0
Q32.1	Q32.2	Q32.3	Q32.4

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