FAX 866-372-0380 or SECURE EMAIL info@hcshme.com

INITIAL COVERAGE:

In this policy, the term bi-level respiratory assist device without back-up rate (E0470) refers  when it is used in the treatment of obstructive sleep apnea. 

1. An E0470 device is covered for the treatment of obstructive sleep apnea (OSA) if criteria A – D are met:

A. 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.

B. The beneficiary has a sleep test (as defined below) that meets either of the following criteria (1 or 2):

1. 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,

2. 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.

C.  The beneficiary and/or their caregiver has received instruction from the supplier of the device in the proper use and care of the equipment.

D.  An E0601 (CPAP)  been tried and proven ineffective based on a therapeutic trial conducted in either a facility or in a home setting documenting failure to :

• Adequately control the symptoms of OSA; or,
• Improve sleep quality; or, 
• Reduce the AHI/RDI to acceptable levels.

Replacement:

If a E0470 (bi-level respiratory assist device without back-up rate) is replaced following the 5 year RUL, there must be an in-person evaluation by their treating practitioner that documents that the beneficiary continues to use and benefit from the bi-level respiratory assist device without back-up rate device. There is no requirement for a new sleep test or trial period. 

Restart:

Beneficiaries who fail the initial 12 week trial are eligible to re-qualify for a bi-level respiratory assist device without back-up rate device but must have both:

1. In-person clinical re-evaluation by the treating practitioner to determine the etiology of the failure to respond to bi-level respiratory assist device without back-up rate therapy; and,

2. Repeat sleep test in a facility-based setting (Type 1 study). This may be a repeat diagnostic, titration or split-night study.

Link to Medicare Criteria Website