Appeal type: Surgery
Decision: Favorable

We decided that the Plan has to pre-approve the CardioMEMS HF system.
You asked the Plan to pre-approve implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system components (C2624) and Transcatheter implantation of wireless pulmonary artery pressure sensor for long-term hemodynamic monitoring, including deployment and calibration of the sensor, right heart catheterization, selective pulmonary catheterization, radiological supervision and interpretation, and pulmonary artery angiography, when performed (33289). You say that the enrollee would benefit from the system. The Plan denied your request. The Plan says that in order for the CardioMems device to be covered the enrollee would need to be in a Medicare approved study.
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 implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system components (C2624) and Transcatheter implantation of wireless pulmonary artery pressure sensor for long-term hemodynamic monitoring, including deployment and calibration of the sensor, right heart catheterization, selective pulmonary catheterization, radiological supervision and interpretation, and pulmonary artery angiography, when performed (33289). Our reviewer says that the requested items/services are considered medically reasonable and necessary in this case. Our physician reviewer found use of the CardioMEMS device is reasonable and has clinical data, expert opinion, and approved FDA indications to back up its use in selected appropriate clinical situations like this one. It would therefore meet the medical reasonableness and necessity criteria of the applicable CMS Section 1862(a) 1(A) rule. The device would also not be considered investigational and there is no applicable CMS rule requiring participation in a trial necessary for its implantation. We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of implantable wireless pulmonary artery pressure sensor with delivery catheter, including all system components (C2624) and Transcatheter implantation of wireless pulmonary artery pressure sensor for long-term hemodynamic monitoring, including deployment and calibration of the sensor, right heart catheterization, selective pulmonary catheterization, radiological supervision and interpretation, and pulmonary artery angiography, when performed (33289) have been met. Therefore, we decided that the Plan has to pre-approve the CardioMEMS HF system.
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.