E0601 Medicare coverage

Local coverage indication

An E0601 device is covered for the treatment of obstructive sleep apnea (OSA) if criteria A – C are met: The beneficiary has an in-person clinical evaluation by the treating practitioner prior to the sleep test to assess the beneficiary for obstructive sleep apnea. The beneficiary has a sleep test (as defined below) that meets either of the following criteria (1 or 2): 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, 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: Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia; or, Hypertension, ischemic heart disease, or history of stroke. The beneficiary and/or their caregiver has received instruction from the supplier of the device in the proper use and care of the equipment. If a claim for an E0601 is submitted and all of the criteria above have not been 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.

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