E0561 — Humidifier, non-heated, used with positive airway pressure device
HCPCS/CPT
Prior Authorization
Prior Auth Required
Conditional coverage; review criteria to confirm PA need (medium confidence)
Documentation Required
- A Standard Written Order (SWO) must be communicated to the supplier before claim submission, and a signed Written Order Prior to Delivery (WOPD) must be received before delivery of DMEPOS base items; the SWO/WOPD must list the base item and may list separately billed options/accessories.
- Sleep test documentation must demonstrate compliance with NCD 240.4.1 and applicable A/B MAC LCD/Billing & Coding articles, show FDA approval of the diagnostic device, be ordered by the treating practitioner, and be conducted by a Medicare-qualified and state-compliant provider.
- To justify billing an E0470 for OSA, documentation must show an E0601 was tried and proven ineffective during facility titration or home use despite optimal therapy (proper mask fitting and appropriate pressure settings).
Key Coverage Criteria
- A single-level CPAP device (E0601) is covered for obstructive sleep apnea (OSA) when the beneficiary has an in-person clinical evaluation by the treating practitioner prior to the sleep test.
- An E0601 is covered when a valid sleep test shows AHI or RDI >= 15 events/hour with a minimum total of 30 events.
- An E0601 is covered when a valid sleep test shows AHI or RDI between 5 and 14 events/hour with a minimum total of 10 events and there is documented excessive daytime sleepiness, impaired cognition, mood disorder, insomnia, or cardiovascular comorbidity (hypertension, ischemic heart disease, or history of stroke).
- The beneficiary and/or caregiver must receive instruction from the supplier in proper use and care of the PAP equipment before coverage of the device.
- The diagnosis of OSA for PAP coverage must be based on a Medicare-valid sleep test (Type I/II/III/IV/Other) that is FDA-approved as a diagnostic device, ordered by the treating practitioner, and conducted by a Medicare-qualifying sleep test provider in compliance with state regulations.
- A bi-level respiratory assist device without back-up rate (E0470) is covered for OSA when criteria A–C for E0601 are met and a therapeutic trial of E0601 has been tried and proven ineffective.
5 Active Policies
L33718 — Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea
J19
L33800 — Respiratory Assist Devices
J19
EVICORE-SLEEP-DISORDERED-BREATHING-GUIDELINES — Sleep Management Guidelines
ANTHEM-MED.00002 — MED.00002 Selected Sleep Testing Services
Related Codes
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