LCD L33800: Respiratory Assist Devices

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

• The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

• The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

• Refer to the Supplier Manual for additional information on documentation requirements.

• Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the “reasonable and necessary” criteria, based on Social Security Act § 1862(a)(1)(A) provisions, are defined by the following coverage indications, limitations and/or medical necessity.

DEFINITIONS

For purposes of this policy the following definitions are used:

- FIO2 is the fractional concentration of oxygen delivered to the beneficiary for inspiration. The beneficiary’s prescribed FIO2 refers to the oxygen concentration the beneficiary normally breathes when not undergoing testing to qualify for coverage of a Respiratory Assist Device (RAD). That is, if the beneficiary does not normally use supplemental oxygen, their prescribed FIO2 is that found in room air.

- FEV1 is the forced expired volume in 1 second.

- FVC is the forced vital capacity.

- Central sleep apnea (CSA) is defined by all of the following:

• An apnea-hypopnea index (AHI) greater than or equal to 5; and

• The sum total of central apneas plus central hypopneas is greater than 50% of the total apneas and hypopneas; and

• A central apnea-central hypopnea index (CAHI) is greater than or equal to 5 per hour; and

• The presence of at least one of the following:

• Sleepiness

• Difficulty initiating or maintaining sleep, frequent awakenings, or non-restorative sleep

• Awakening short of breath

• Snoring

• Witnessed apneas

• There is no evidence of daytime or nocturnal hypoventilation

- Complex sleep apnea (CompSA) is a form of central apnea specifically identified by all of the following:

• With use of a positive airway pressure device without a backup rate (E0601 or E0470), the polysomnogram (PSG) shows a pattern of apneas and hypopneas that demonstrates the persistence or emergence of central apneas or central hypopneas upon exposure to CPAP (E0601) or a bi-level device without backup rate (E0470) device when titrated to the point where obstructive events have been effectively treated (obstructive AHI less than 5 per hour).

• After resolution of the obstructive events, the sum total of central apneas plus central hypopneas is greater than 50% of the total apneas and hypopneas; and

• After resolution of the obstructive events, a central apnea-central hypopnea index (CAHI) greater than or equal to 5 per hour.

- Apnea is defined as the cessation of airflow for at least 10 seconds.

- Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds associated with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% decrease in oxygen saturation.

- The apnea-hypopnea index (AHI) is defined as the average number of episodes of apnea and hypopnea per hour of sleep without the use of a positive airway pressure device.

- For diagnosis of CSA, the central apnea-central hypopnea index (CAHI) is defined as the average number of episodes of central apnea and central hypopnea per hour of sleep without the use of a positive airway pressure device. For CompSA, the CAHI is determined during the use of a positive airway pressure device after obstructive events have disappeared.

- If the AHI or CAHI is calculated based on less than 2 hours of continuous recorded sleep, the total number of recorded events used to calculate the AHI or CAHI must be at least the number of events that would have been required in a 2-hour period (i.e., greater than or equal to 10 events).

- See the Sleep Tests section below for a discussion of (PSG) and portable home sleep testing (HST).

- If there is discontinuation of usage of an E0470 or E0471 device at any time, the supplier is expected to ascertain this, and stop billing for the equipment and related accessories and supplies.

INITIAL COVERAGE CRITERIA FOR E0470 AND E0471 DEVICES:

For an E0470 or an E0471 RAD to be covered, the treating practitioner must fully document in the beneficiary’s medical record symptoms characteristic of sleep-associated hypoventilation, such as daytime hypersomnolence, excessive fatigue, morning headache, cognitive dysfunction, dyspnea.

A RAD (E0470, E0471) is covered for those beneficiaries with one of the following clinical disorders: restrictive thoracic disorders (i.e., neuromuscular diseases or severe thoracic cage abnormalities), CSA or CompSA, hypoventilation syndrome, or chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD), as described in the following section.

Restrictive Thoracic Disorders

An E0470 or E0471 device is covered when criteria A – C are met.

• There is documentation in the beneficiary’s medical record of a neuromuscular disease (for example, amyotrophic lateral sclerosis) or a severe thoracic cage abnormality (for example, post-thoracoplasty for TB).

• One of the following:

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

• 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 beneficiary’s prescribed recommended FIO2, or

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

• Maximal inspiratory pressure is less than 60 cm H20, or

• Forced vital capacity is less than 50% predicted

• Chronic obstructive pulmonary disease does not contribute significantly to the beneficiary’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 practitioner) will be covered for the first three months of therapy.

If all of the above criteria are not met, then E0470 or E0471 and related accessories will be denied as not reasonable and necessary.

See CONTINUED COVERAGE CRITERIA FOR E0470 AND E0471 DEVICES BEYOND THE FIRST THREE MONTHS for information on more than three months use.

Central Sleep Apnea or Complex Sleep Apnea

An 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):

• The diagnosis of CSA or CompSA; and

• 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 beneficiary’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 practitioner) will be covered for beneficiaries with documented CSA or CompSA for the first three months of therapy.

If all of the above criteria are not met, then E0470 or E0471 and related accessories will be denied as not reasonable and necessary.

See CONTINUED COVERAGE CRITERIA FOR E0470 AND E0471 DEVICES BEYOND THE FIRST THREE MONTHS for information on more than three months use.

Hypoventilation Syndrome

An E0470 device is covered if both criteria A and B and either criterion C or D are met.

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

• Spirometry shows an FEV1/FVC greater than or equal to 70%. (Refer to Chronic Respiratory Failure Consequent to COPD for information about device coverage for beneficiaries with FEV1/FVC less than 70%.)

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

• 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 (PAP) Devices for the Treatment of Obstructive Sleep Apnea LCD for information about E0470 coverage for obstructive sleep apnea.)

If the above criteria are not met, E0470 and related accessories will be denied as not reasonable and necessary.

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

• A covered E0470 device is being used.

• Spirometry shows an FEV1/FVC greater than or equal to 70%. (Refer to Chronic Respiratory Failure Consequent to COPD for information about device coverage for beneficiaries with FEV1/FVC less than 70%.)

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

• 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 (PAP) Devices for the Treatment of Obstructive Sleep Apnea LCD for information about E0470 coverage for obstructive sleep apnea.)

If the criteria above are not met, an E0471 device will be denied as not reasonable and necessary.

See CONTINUED COVERAGE CRITERIA FOR E0470 AND E0471 DEVICES BEYOND THE FIRST THREE MONTHS for information on more than three months use.

Chronic Respiratory Failure Consequent to COPD

A respiratory assist device is covered when the beneficiary meets the initial coverage criteria for either an E0470 or E0471 as described in the Medicare National Coverage Determinations (NCD) Manual (CMS Pub. 100-03) Chapter 1, Part 4, Section 240.9 Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure (CRF) Consequent to Chronic Obstructive Pulmonary Disease (COPD).

See CONTINUED COVERAGE CRITERIA FOR E0470 OR E0471 DEVICES BEYOND THE FIRST SIX MONTHS for information on more than six months use.

VENTILATORS

The Medicare National Coverage Determinations (NCD) Manual (CMS Pub. 100-03) Chapter 1, Part 4, Section 240.9 outlines initial and continuing usage criteria for home mechanical ventilators for the treatment of CRF consequent to COPD.

Additionally, the Medicare National Coverage Determinations (NCD) Manual (CMS Pub. 100-03) in Chapter 1, Part 4, Section 280.1 stipulates that ventilators (E0465, E0466, and E0467) are covered for the following conditions:

“[N]euromuscular diseases, thoracic restrictive diseases, and chronic respiratory failure consequent to chronic obstructive pulmonary disease (See §240.9 of this manual).”

Each of these disease categories are comprised of conditions that can vary from severe and life-threatening to less serious forms. These ventilator-related disease groups overlap conditions described in this Respiratory Assist Devices LCD used to determine coverage for bi-level PAP devices. Each of these disease categories are conditions where the specific presentation of the disease can vary from beneficiary to beneficiary. For conditions such as these, the specific treatment plan for any individual beneficiary will vary as well. Choice of an appropriate treatment plan, including the determination to use a ventilator vs. a bi-level PAP device, is made based upon the specifics of each individual beneficiary's medical condition and consideration of coverage criteria outlined in the Respiratory Assist Devices LCD, NCD 280.1, and/or NCD 240.9. In the event of a claim review, there must be sufficient detailed information in the medical record to justify the treatment selected.

Ventilators fall under the Frequent and Substantial Servicing (FSS) payment category, and payment policy requirements preclude FSS payment for devices used to deliver continuous and/or intermittent positive airway pressure, regardless of the illness treated by the device. (Social Security Act 1834(a)(3)(A)) This means that products currently classified as HCPCS code E0465, E0466, or E0467 when used to provide CPAP or bi-level PAP (with or without backup rate) therapy, regardless of the underlying medical condition, shall not be paid in the FSS payment category. A ventilator is not eligible for reimbursement for any of the conditions described in this RAD LCD even though the ventilator equipment may have the capability of operating in a bi-level PAP (E0470, E0471) mode. Claims for ventilators used to provide CPAP or bi-level CPAP therapy for conditions described in this RAD policy will be denied as not reasonable and necessary.

General principles of correct coding require that products assigned to a specific HCPCS code only be billed using the assigned code. Thus, using the HCPCS codes for CPAP (E0601) or bi-level PAP (E0470, E0471) devices for a ventilator (E0465, E0466, or E0467) used to provide CPAP or bi-level PAP therapy is incorrect coding. Claims for ventilators billed using the CPAP or bi-level PAP device HCPCS codes will be denied as incorrect coding.

CONTINUED COVERAGE CRITERIA FOR E0470 AND E0471 DEVICES BEYOND THE FIRST THREE MONTHS OF THERAPY FOR RESTRICTIVE THORACIC DISORDERS, CSA, COMPSA, OR HYPOVENTILATION SYNDROME

Beneficiaries covered for the first three months of an E0470 or an E0471 device for the treatment of restrictive thoracic disorders, CSA, CompSA, or hypoventilation syndrome must be re-evaluated to establish the medical necessity of continued coverage by Medicare beyond the first three months. While the beneficiary may certainly need to be evaluated at earlier intervals after this therapy is initiated, the re-evaluation upon which Medicare will base a decision to continue coverage beyond this time must occur no sooner than 61 days after initiating therapy by the treating practitioner. Medicare 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 beneficiary’s medical record about the progress of relevant symptoms and beneficiary usage of the device up to that time. Failure of the beneficiary 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 Medicare to deny continued coverage as not reasonable and necessary.

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

If the above criteria are not met, continued coverage of an E0470 or an E0471 device and related accessories will be denied as not reasonable and necessary.

CONTINUED COVERAGE CRITERIA FOR E0470 OR E0471 DEVICES BEYOND THE FIRST SIX MONTHS FOR CRF CONSEQUENT TO COPD

For continued coverage of an E0470 or E0471 for the treatment of CRF consequent to COPD beyond the first 6-months of therapy, the beneficiary must meet the continuing usage criteria for a RAD as described in the Medicare National Coverage Determinations (NCD) Manual (CMS Pub. 100-03) Chapter 1, Part 4, Section 240.9 Noninvasive Positive Pressure Ventilation (NIPPV) in the Home for the Treatment of Chronic Respiratory Failure (CRF) Consequent to Chronic Obstructive Pulmonary Disease (COPD).

ACCESSORIES

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