Appeal type: DME/ Orthotics
Decision: Favorable

We decided that the Plan has to pre-approve implantation of carotid sinus baroreflex activation device.

You asked the Plan to pre-approve implantation of carotid sinus baroreflex activation device; total system (includesgenerator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed) (0266T). You say that this system is medically necessary for this enrollee.The Plan denied your request. The Plan says that there are not enough medical studies to show the device will help with the enrollee's condition/care.

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 implantation or replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed) (0266T). Our reviewer says that the requested items/services are considered medically reasonable and necessary in this case. Our physician reviewer found although based on current available data, the device is not indicated in all Congestive Heart Failure (CHF)situations, given that guideline directed medical therapy for CHF cannot be given to this patient due to hypotension and orthostasis, alternative treatment regimens need to be considered.  Since the patient does not also qualify for a biventricular pacemaker device as well, the requesteddevice implantation is a reasonable alternative in this specific clinical situation. The published data also suggests that patients who do not qualify for biventricular pacing therapy are the ones most likely to benefit most from this device and the device is FDA approved for these specific indications. Therefore,based on the applicable CMS 1862 (a) rule, the requested device used in this specific clinical circumstance would be considered medically reasonable and necessary and therefore meets the applicable CMS criteria for is use and coverage.

We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of implantation or replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed) (0266T) have been met.Therefore, we decided that the Plan has to pre-approve implantation of carotid sinus baroreflex activation device.

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.