Appeal type: DME/ Orthotics
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve a home ventilator (E0466). 
 
You asked the Plan to pre-approve a home ventilator. You say that the enrollee needs the ventilator to control 
co2 levels. The enrollee was readmitted recently and had to be incubated. The Plan denied your request. The 
Plan says the request for a non-invasive ventilator (NIV) is not medically necessary because the documentation 
does not support that this device meets but does not exceed the enrollee's need. The documentation does not 
support that the use a BiPAP device would not meet the enrollee's medical needs since it was used in the 
hospital with successful discharge. 
 
The Plan must follow Medicare rules. The rules say that ventilators may be covered when they are medically 
necessary for patients who have neuromuscular disease, thoracic restrictive diseases, and chronic respiratory 
failure due to COPD. We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pre-approve a home ventilator. Our reviewer says 
that the service is not medically necessary. Our physician reviewer found the enrollee has a diagnosis of 
chronic respiratory failure consequent to chronic obstructive pulmonary disease. Provided records document 
that the home ventilator is being requested for use in average volume assured pressure support (AVAPS) mode 
with auto-EPAP (AE) which could be provided by a bilevel positive airway pressure (BiPAP) device with 
AVAPS and a back-up rate. Provided records do not document trial and failure of a BiPAP device with 
AVAPS and a back-up rate. As stated in the Local Coverage Determination (L33800): "Ventilators fall under 
the Frequent and Substantial Servicing (FSS) payment category, and payment policy requirements preclude 
FSS payment for devices used to deliver continuous and/or intermittent positive airway pressure, regardless of 
the illness treated by the device. (Social Security Act 1834(a)(3)(A)) This means that products currently 
classified as HCPCS code E0465, E0466, or E0467 when used to provide CPAP or bi-level PAP (with or 
without backup rate) therapy, regardless of the underlying medical condition, shall not be paid in the FSS 
payment category. A ventilator is not eligible for reimbursement for any of the conditions described in this 
RAD LCD even though the ventilator equipment may have the capability of operating in a bi-level PAP 
(E0470, E0471) mode. Claims for ventilators used to provide CPAP or bi-level CPAP therapy for conditions 
described in this RAD policy will be denied as not reasonable and necessary." The LCD requires: "There must 
be enough detailed information in the medical record to justify the treatment selected." Provided records in this 
case do not provide adequate detailed information to meet Medicare criteria for coverage of a ventilator as 
opposed to a BiPAP device with AVAPS and a back-up rate. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of a home ventilator have not been met. Therefore, we decided that the Plan does 
not have to pre-approve a home ventilator (E0466).