Appeal type: DME/ Orthotics
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve a home ventilator, any type, used with non-invasive 
interface, (e.g., mask, chest shell) (E0466). 
 
You asked the Plan to pre-approve a ventilator. You say that you request reconsideration for therapy as the 
enrollee has multiple underlying chronic conditions which increases risk of readmission. The Plan denied your request. The Plan says the records do not show that the enrollee meets the criteria for the requested breathing 
machine. 
 
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. Claims for ventilators used to provide CPAP or bi-level CPAP therapy will be denied as 
not reasonable and necessary. 
 
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 ventilator. Our reviewer says that the 
requested items/services are not considered medically reasonable and necessary in this case. Our physician 
reviewer found the provided records document that the home ventilator is being requested for use in an average 
volume assured pressure support (AVAPS) mode which is a modality that 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 (LCD) 33800: "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 (Respiratory Assist Device) 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 ventilator have not been met. Therefore, we decided that the Plan does not 
have to pre-approve a home ventilator, any type, used with non-invasive interface, (e.g., mask, chest shell) 
(E0466).