Appeal type: DME/ Orthotics
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve nine (9) months of continued use of a noninvasive 
ventilator (E0466). 
 
You asked the Plan to pre-approve continued use of a ventilator. You say that you are requesting 
reconsideration due to medical necessity. The Plan denied your request. The Plan says the request for continued 
use of non-invasive ventilator (NIV) is not medically reasonable and necessary. The documentation indicates 
that this device is being used solely for bilevel pressure delivery or BiPAP mode, and thus it is being used 
solely as a respiratory assist device. 
 
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 continued use of a 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 continued use of a ventilator have not been met. Therefore, we decided that the 
Plan does not have to pre-approve nine (9) months of continued use of a noninvasive ventilator (E0466).