Appeal type: Practitioner Services
Decision: Favorable

We decided that the Plan has to pre-approve a CardioMems device.

You asked the Plan to pre-approve a CardioMems device. You say that the requested device is medically necessary for the enrollee's condition. The Plan denied your request. The Plan says that this device has not been found to have an established clinical benefit or effect on health outcomes.

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 CardioMems device. Our reviewer says that the requested items/services are considered medically reasonable and necessary in this case. Our physician reviewer found that the patient has NYHA Class III heart failure with preserved ejection fraction and is on a high dose oral diuretic regimen also including intermittent outpatient IV diuretics with recent hospitalization for congestive heart failure requiring mechanical ventilation for several days. She has moderately severe pulmonary hypertension and elevated cardiac filling pressures despite medical therapy. Management of her heart failure with standard medical therapy and relying on symptoms, weights and signs has not been effective in keeping her with minimal symptoms and has resulted in acute hospitalizations. CardioMems device monitoring in this situation can provide additional heart filling pressure data to better manage very complex regimens to optimize fluid status. 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 Federal Drug Administration (FDA) approved indications all of which are met in this clinical instance. Given the severe symptoms of recurrent congestive heart failure which appears very sensitive to volume loading conditions, complexity of the medical regimen and the failure to prevent acute congestive heart failure hospitalization in this patient, 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. 

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 CardioMems device have been met. Therefore, we decided that the Plan has to pre-approve a CardioMems 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.