E0470 Medicare coverage

Local coverage indication

An E0470 device is covered for those beneficiaries with OSA who meet criteria A-C above, in addition to criterion D: An 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 beneficiary with OSA and criteria A-D are not met, it will be denied as not reasonable and necessary.

Excerpt from LCD L33718 version 52, effective 01/01/2024. CMS LCD L33718.

What NCD 240.4 says the item is

A. General Continuous Positive Airway Pressure (CPAP) is a non-invasive technique for providing single levels of air pressure from a flow generator, via a nose mask, through the nares. The purpose is to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep, which occurs in obstructive sleep apnea (OSA). The apnea hypopnea index (AHI) is equal to the average number of episodes of apnea and hypopnea per hour. The respiratory disturbance index (RDI) is equal to the average number of respiratory disturbances per hour. Apnea is defined as a cessation of airflow for at least 10 seconds. Hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds with at least a 30% reduction in thoracoabdominal movement or airflow as compared to baseline, and with at least a 4% oxygen desaturation.

National coverage indication, NCD 240.4

B. Nationally Covered Indications Effective for claims with dates of service on and after March 13, 2008, the Centers for Medicare & Medicaid Services (CMS) determines that CPAP therapy when used in adult patients with OSA is considered reasonable and necessary under the following situations: The use of CPAP is covered under Medicare when used in adult patients with OSA. Coverage of CPAP is initially limited to a 12-week period to identify beneficiaries diagnosed with OSA as subsequently described who benefit from CPAP. CPAP is subsequently covered only for those beneficiaries diagnosed with OSA who benefit from CPAP during this 12-week period. The provider of CPAP must conduct education of the beneficiary prior to the use of the CPAP device to ensure that the beneficiary has been educated in the proper use of the device. A caregiver, for example a family member, may be compensatory, if consistently available in the beneficiary's home and willing and able to safely operate the CPAP device.

Excerpt from NCD 240.4 version 3. CMS NCD 240.4.

Local coverage indication

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.

Excerpt from LCD L33800 version 43, effective 06/09/2025. CMS LCD L33800.

What NCD 240.9 says the item is

A. General Respiratory Assist Devices (RADs) with bi-level capability, with or without a backup rate feature, are devices that use a non-invasive interface (mask) to deliver a higher level of airway pressure when the patient inhales than when the patient exhales. A backup rate feature on certain RADs enables the device to provide a prespecified respiratory rate if the patient’s spontaneous respiratory rate decreases below a set number. Compared with RADs, home mechanical ventilators (HMVs) typically have additional ventilatory modes, monitoring, ventilator control, and safety, alarm, and backup power features (batteries).

National coverage indication, NCD 240.9

B. Nationally Covered Indications I. Respiratory Assist Devices (RADs) (a) Initial Coverage Criteria (i) RAD with Backup Rate Feature The Centers for Medicare & Medicaid Services (CMS) will cover in the home a RAD with backup rate feature to deliver high intensity noninvasive ventilation (NIV) as treatment for patients with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD). A RAD with backup rate feature is covered in the home for an initial 6-month period for patients with COPD when all the following criteria are met: The patient exhibits persistent hypercapnia as demonstrated by PaCO2 ≥ 52 mmHg by arterial blood gas during awake hours while breathing his/her prescribed FiO2; and Sleep apnea is not the predominant cause of the hypercapnia (Formal sleep testing is not required if, per the treating clinician, the patient does not experience sleep apnea as the predominant cause of hypercapnia.

Excerpt from NCD 240.9 version 1. CMS NCD 240.9.

From A52467

In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD. Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below. INITIAL EVALUATION: For the initial in-person evaluation, the report would commonly document pertinent information about the following elements, but may include other details. Each element would not have to be addressed in every evaluation. History Signs and symptoms of sleep disordered breathing including snoring, daytime sleepiness, observed apneas, choking or gasping during sleep, morning headaches Duration of symptoms Validated sleep hygiene inventory such as the Epworth Sleepiness Scale (see

CMS source A52467

From A55426, Standard Documentation Requirements for All Claims Submitted to DME MACs

GENERAL There are numerous CMS manual requirements, reasonable and necessary (R&N) requirements, benefit category, and other statutory and regulatory requirements that must be met in order for payment to be justified. In the event of a claim review, a DMEPOS supplier must provide sufficient information to demonstrate that the applicable criteria have been met thus justifying payment. Before submitting a claim to Medicare, the DMEPOS supplier must have on file an SWO, a WOPD (if applicable), information from the treating practitioner concerning the patient's diagnosis, and any information required for the use of specific

CMS article A55426

From A52517

REPLACEMENT OF ACCESSORIES FOR MEDICARE-PAID, BENEFICIARY-OWNED EQUIPMENT: For claims for replacement accessories (e.g., interfaces, tubing, filters, humidifier chambers), if Medicare paid for the base RAD initially (i.e., for 13 months of continuous use), the medical necessity for the beneficiary-owned base RAD is assumed to have been established. Therefore, to make a payment determination, there must only be documentation that the base DME item continues to meet medical need; and (2) The replacement of specific accessories or furnishing of new accessories remain medically necessary and are essential for the effective use of the base DME. Documentation of continued medical need for the base item must come from the treating practitioner’s records. The supplier's documentation records must support the need to replace the accessory to maintain the equipment's functionality and meet the beneficiary's medical need. This guidance does not apply RADs when Medicare did not originally provide payment for the base item. In cases where Medicare did not originally pay for the DME item, all coverage, coding and documentation requirements in effect for the date of service (DOS) on the claim under review must be met ( see " Coverage Indications, Limitations, and/or Medical Necessity" section of the related LCD).

CMS source A52517

From A55426, Standard Documentation Requirements for All Claims Submitted to DME MACs

GENERAL There are numerous CMS manual requirements, reasonable and necessary (R&N) requirements, benefit category, and other statutory and regulatory requirements that must be met in order for payment to be justified. In the event of a claim review, a DMEPOS supplier must provide sufficient information to demonstrate that the applicable criteria have been met thus justifying payment. Before submitting a claim to Medicare, the DMEPOS supplier must have on file an SWO, a WOPD (if applicable), information from the treating practitioner concerning the patient's diagnosis, and any information required for the use of specific

CMS article A55426