Appeal type: Surgery
Decision: Favorable

We decided that the Plan has to pre-approve a CardioMEMS system for the enrollee.
You asked the Plan to pre-approve these services. You say that these services are medically necessary. The Plan denied your request. The Plan says that that coverage cannot be approved for a CardioMEMS system because there is not enough medical proof to show the safety and/or success for heart failure monitoring.
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 these services. Our reviewer says that the requested services are considered medically reasonable and necessary in this case. The patient has severe heart failure and was recently hospitalized for decompensated congestive heart failure (CHF). Management of his heart failure with standard medical therapy and relying on symptoms and signs has not been effective in keeping him with minimal symptoms and has resulted in acute hospitalization and has been complicated by baseline hypotension making medical management of symptoms difficult. Cardiomems device monitoring in this situation can provide additional heart filling pressure data to better manage complex diuretic and vasodilator regimens with ongoing NYHA Class III symptoms. Data from the Champions trial along with longer term follow-ups studies have shown a significant decrease in hospitalizations and improvement in heart failure symptoms and NYHA Class with the use of this device. There is also published expert opinion in the cardiology literature as to its appropriate use, as well as reasonable patient selection criteria, and FDA approved indications, all of which are met in this clinical instance. Given the severe symptoms of recurrent CHF which appears very sensitive to volume loading conditions, the chronic hypotension limiting medical therapy and making meticulous volume management critical, and the failure of conventional management strategies to prevent acute CHF hospitalization in this patient, use of the Cardiomems device is reasonable and has clinical data, expert opinion, and approved FDA indications to recommend its use in selected appropriate clinical situations like this one. Our physician reviewer found that the enrollee's condition meets Medicare criteria for these services. We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that Medicare rules for coverage of these services have been met. Therefore, we decided that the Plan has to pre-approve a CardioMEMS system for the enrollee.
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.