Appeal type: Inpatient Hospital
Decision: Favorable

We decided that the Plan has to pre-approve a Zephyr valve procedure (31634, 31647, and 31651) and inpatient hospital stay, as requested.
You asked the Plan to pre-approve a Zephyr valve procedure (31634, 31647, and 31651) and inpatient hospital stay. You say that the requested Zephyr valve procedure and inpatient hospital stay are medically necessary. The Plan denied your request. The Plan says that the requested Zephyr valve procedure and inpatient hospital stay are not medically necessary.
The Plan must follow Medicare rules. Medicare rules say that if there are no specific coverage rules for an item or service, then that item or service will be covered when it is medically 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 Zephyr valve procedure (31634, 31647, and 31651) and inpatient hospital stay. Our reviewer says that the requested Zephyr valve procedure and inpatient hospital stay are medically necessary. Our physician reviewer found the enrollee is with emphysema/chronic obstructive pulmonary disease (COPD). The enrollee's pulmonary function is FEV1 26% predicted. Residual volume (RV) is 242% predicted. Centrilobular emphysema with complete fissures on chest CT. The enrollee is on oxygen, and BiPAP with good compliance. Endobronchial valve (EBV) placement, performed as an inpatient with at least 3 nights hospital stay, is considered reasonable and medically necessary for this enrollee. EBV placement has been evaluated in several well-designed clinical trials that included sham control procedures with randomization and blinding. This includes a very recently published high-quality trial. The procedure confers the same benefits as surgical lung reduction surgery, but without the surgery. There is a high risk of pneumothorax caused by rapid expansion of untreated lobes, especially in the first few days after the procedure. Rapid recognition and treatment of this complication is necessary, and this is the reason for the inpatient hospital stay. Nevertheless, studies show a favorable risk-benefit profile for this procedure. The 2020 GOLD update for chronic obstructive pulmonary disease (COPD) gives this treatment an evidence rating of "A". This enrollee meets the clinical criteria for the procedure. She is on maximum medical therapy, with no other reasonable alternative treatments. 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 Zephyr valve procedure (31634, 31647, and 31651) and inpatient hospital stay have been met. Therefore, we decided that the Plan has to pre-approve a Zephyr valve procedure (31634, 31647, and 31651) and inpatient hospital stay, as requested.
If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will send you a letter.