INITIAL COVERAGE:
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.
For more detailed and up to date information, please refer to the CMS.gov website: