Appeal type: Surgery
Decision: Favorable

We decided that the Plan has to pre-approve the Watchman left atrial appendage closure implant procedure.
You asked the Plan to pre-approve the Watchman atrial appendage closure device: Echocardiography, transesophageal, real-time with image documentation (2D) (with or without M-mode recording); including probe placement, image acquisition, interpretation and report (93312) and Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation (33340). You say that long term anticoagulation is not advisable. The Plan denied your request. The Plan says that there is no evidence the enrollee is unable to take long-term oral anticoagulation.
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 the Watchman atrial appendage closure device: Echocardiography, transesophageal, real-time with image documentation (2D) (with or without M-mode recording); including probe placement, image acquisition, interpretation and report (93312) and Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation (33340). Our reviewer says that the requested items/services are considered medically reasonable and necessary in this case. Our physician reviewer found the enrollee meets the CMS NCD criteria for her embolic risk by CHA2DS2VASc score and her increased risk of bleeding (CLL, elevated HASBLED score). An additional complicating factor, which is also clinically relevant but not included in the formal decision model in this instance, is the recurrent need to discontinue anti-coagulation for more prolonged periods when getting spinal nerve injections for her chronic back pain. The
repeated starting and stopping of anticoagulation would add additionally to her baseline elevated embolic risk as well. As she meets CMS NCD criteria for the Watchman device as noted above, and she has an added clinical risk of regularly discontinuing anticoagulation for the back procedures, the use of the Watchman device in lieu of anticoagulation for this clinical situation is reasonable, medically necessary, and also meets the applicable CMS criteria for its use. We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of the Watchman atrial appendage closure device: Echocardiography, transesophageal, real-time with image documentation (2D) (with or without M-mode recording); including probe placement, image acquisition, interpretation and report (93312) and Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation (33340) have been met. Therefore, we decided that the Plan has to pre-approve the Watchman left atrial appendage closure implant procedure.
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.