Medical_Policy

Mountain State Medical Policy Bulletin

Section:	Durable Medical Equipment
Number:	E-34
Topic:	Respiratory Assist Devices
Effective Date:	August 1, 2005
Issued Date:	August 1, 2005
Date Last Reviewed:	07/2005

General Policy Guidelines

Indications and Limitations of Coverage

Noninvasive positive pressure respiratory assistance (NPPRA) therapy is covered for those patients with clinical disorder groups characterized as (I) restrictive thoracic disorders (i.e., progressive neuromuscular diseases or severe thoracic cage abnormalities), (II) severe chronic obstructive pulmonary disease (COPD), (III) central sleep apnea (CSA), or (IV) obstructive sleep apnea (OSA) (E0470 only). See the attachment for specific criteria for these conditions.

The following accessories are reimbursable as follows when used with E0470 or E0471:

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 1 month
A7038 - 2 per 1 month
A7039 - 1 per 6 months

Requests for more than the usual replacement amount are not medically necessary. On an individual consideration basis, consideration can be given to larger quantities when documentation is received which justifies the larger quantity.

Heated and non-heated humidification is eligible for use with a covered respiratory assist device when prescribed by the treating physician to meet the needs of the individual patient.

All equipment and accessories are covered as durable medical equipment and must be prescribed by a physician.

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.

Polysomnographic studies must be performed on stationary equipment.

Coverage for DME is determined according to individual or group customer benefits.

NOTE:: Total payments for a rental item may not exceed its allowable purchase price, except for those items identified as life sustaining DME. For information on continuous rental of life sustaining DME, see Medical Policy Bulletin E-38, Continuous Rental of Life Sustaining Durable Medical Equipment (DME).

Description

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). It may sometimes be applied to assist insufficient respiratory efforts in the treatment of conditions that may involve sleep-associated hypoventilation. It is to be distinguished from the invasive ventilation administered via a securely intubated airway, in a patient for whom interruption or failure of ventilatory support would lead to imminent demise of the patient.

A respiratory assist device (RAD) without backup rate (E0470) 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 (i.e., NPPRA).

A respiratory assist device (RAD) with backup rate (E0471) 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 (i.e., NPPRA). In addition, it has a timed backup feature to deliver this air pressure whenever sufficient spontaneous inspiratory efforts fail to occur.

Accessories that are used to deliver air pressure to the patient's nose and/or mouth, and which do not involve an invasive delivery technique such as tracheostomy, are represented by codes A7030, A7031, A7032, A7033, A7034, A7035, A7036, A7037, A7038, A7039, A7044, E0561, and E0562. While these codes have represented accessories used with continuous positive airway pressure devices (CPAP), the same accessories are also used in the application of other forms of NPPRA therapy.

Polysomnography is the continuous and simultaneous monitoring and recording of various physiological and pathophysiological parameters of sleep for 6 or more hours with physician review, interpretation, and report. It must include sleep staging which is defined to include a 1-4 lead electroencephalogram (EEG), and electro-oculogram (EOG), and a submental electromyogram (EMG). It must also include at least the following additional parameters of sleep: airflow, respiratory effort, and oxygen saturation by oximetry.

FIO2 is the fractional concentration of oxygen delivered to the patient for inspiration. For the purpose of this policy, the patient's usual FIO2 refers to the oxygen concentration the patient normally breathes when not undergoing testing to qualify for coverage of NPPRA therapy. That is, if the patient does not normally use supplemental oxygen, their usual FIO2 is that found in room air.

NOTE:: This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Procedure Codes

A7030	A7031	A7032	A7033	A7034	A7035
A7036	A7037	A7038	A7039	A7044	E0470
E0471	E0561	E0562	S8186

Traditional Guidelines

Refer to General Policy Guidelines

FEP Guidelines

Refer to General Policy Guidelines

PPO Guidelines

Refer to General Policy Guidelines

Managed Care POS Guidelines

Refer to General Policy Guidelines

Publications

References

Region A DMERC 14.30

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Table Attachment

Text Attachment

Criteria for Respiratory Assist Devices

Restrictive Thoracic Disorders (Group I)	3 months	E0470 E0471	If all the following criteria are not met, the device and related accessories will be denied as not medically necessary. Presence of a progressive neuromuscular disease, e.g., amyotrophic lateral sclerosis, or a severe thoracic cage abnormality and An arterial blood gas PaC02, done while the patient is awake and breathing their usual FI02, is greater than or equal to 45 mm Hg, or, Sleep oximetry demonstrates oxygen saturation level is less than 88% for at least five continuous minutes, done while the patient is breathing their usual FI02, or, For a progressive neuromuscular disease (only), maximal inspiratory pressure is less than 60 cm H20 or forced vital capacity is less than 50% predicted, and Chronic obstructive pulmonary disease does not contribute significantly to the patient's pulmonary limitation.
Severe COPD (Group II)	3 months	E0470	If all the following criteria are not met, the device and related accessories will be denied as not medically necessary. If E0471 is billed, but the criteria for a E0470 device are met, payment will be based on the allowance for the least costly medically appropriate alternative, E0470. An arterial blood gas PaCO2, done while awake and breathing the patient's usual FI02, is greater than 52 mm Hg, and Sleep oximetry demonstrates oxygen saturation level of less than 88% for at least five continuous minutes, done while breathing oxygen at two LPM or the patient's usual FI02 (whichever is higher) and Prior to initiating therapy, OSA (and treatment with CPAP) has been considered and ruled out.
	2 months	E0471	E0471 device will not be covered for a patient with COPD during the first two months, as therapy with a E0470 device with proper adjustments of the settings and patient accommodation to its use will usually result in sufficient improvement without need of a back-up rate. Following 61 days of use of E0470, the following criteria should be applied when establishing the need for E0471. An arterial blood gas PaCO2 is repeated while the patient is awake and breathing their usual FIO2 and the level remains 52 mm HG and, A sleep oximetry, while the patient is breathing with the E0470 device demonstrates O2 saturation of less than 88% for at least five continuous minutes, done while breathing oxygen at two LPM or the patient's usual FIO2, whichever is higher.
Central Sleep Apnea (Group III)	3 months	E0470 E0471	If all the following criteria are not met, the device and related accessories will be denied as not medically necessary. Prior to initiating therapy, an attended polysomnogram, performed on stationary equipment, must be performed documenting the following: The diagnosis of central sleep apnea (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 Oxygen saturation level of less than 88% for at least five continuous minutes, done while breathing the patient's usual FI02,and Significant improvement of the sleep-associated hypoventilation with the use of a E0470 or E0471 device on the settings that will be prescribed for initial use at home, while breathing the patient's usual FI02.
Obstructive Sleep Apnea (Group IV)	3 months	E0470	An attended polysomnogram, performed on stationary equipment, has established the diagnosis of obstructive sleep apnea, and A single level device (E0601, Continuous Positive Airway Pressure Device) (CPAP) has been tried and proven ineffective. If E0470 is billed and these criteria are not met but the coverage criteria for Continuous Positive Airway Pressure System (CPAP) are met, payment may be made and based on the allowance for the least costly medically appropriate alternative, E0601. See Medical Policy E-20 for guidelines on CPAP.
	3 months	E0471	NOTE: A E0471 device is not medically necessary if the primary diagnosis is OSA. However, payment can be made for E0470 or E0601 as a least costly medically appropriate alternative.

Continued Coverage Beyond the Initial Three Months of Therapy

Re-evaluation to establish the medical necessity of continued coverage of these devices must occur within 61 to 90 days from the date the therapy was initiated. Documentation from this evaluation should become part of the patient's medical record and include information on the progress of relevant symptoms and patient usage of the device up to that time.

Procedure Code Attachment

Glossary

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Mountain State Blue Cross Blue Shield plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Mountain State Blue Cross Blue Shield (MSBCBS) retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of MSBCBS. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.