Appeal type: DME/ Orthotics
Decision: Favorable

We decided that the Plan has to pre-approve the CardioMEMS system.
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 the current evidence is insufficient to support the use of
ambulatory cardiac hemodynamic monitoring using an implantable pulmonary artery pressure measurement
device in individuals with heart failure in an outpatient setting.
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 NYHA
Class III heart failure with preserved ejection fraction and is on a high dose oral diuretic regimen with recurrent
and recent hospitalization for congestive heart failure (CHF). His edema from his right sided CHF has also
resulted in leg wounds requiring chronic wound management care. Management of his heart failure with
standard medical therapy and relying on symptoms, weights and signs has not been effective in keeping him
with minimal symptoms and has resulted in acute hospitalizations within the past year. 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 in a randomized trial and also in longer term follow-up in post marketing
approval follow-up studies. 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 appear sensitive to volume
loading conditions, the complexity of the medical regimen and the failure 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 back up its use in selected appropriate clinical situations like this one. It would therefore
not be considered investigational for this indication and would meet the medical reasonableness and necessity
criteria. Our physician reviewer found that your condition meets 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 preapprove
the CardioMEMS 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