Appeal type: Practitioner Services
Decision: Unfavorable

 
We decided that the Plan does not have to pre-approve a 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, C2624). 
 
You asked the Plan to pre-approve a CardioMEMS device. You say that the device is medically necessary. The 
Plan denied your request. The Plan says due to the lack of literature to support the use of a CardioMEMS 
device and no supporting medical literature that this type of therapy is supported for continued use and benefit 
for the enrollee, this is therefore considered investigational and cannot be approved. 
 
The Plan must follow Medicare rules. Medicare rules say that items and services that are not medically 
necessary are not covered.  
 
 
 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 not considered medically reasonable and necessary in this case. Our 
physician reviewer found at issue is the medical appropriateness and necessity of implantation of the wireless 
pulmonary artery pressure monitoring system (CardioMEMS) for management of CHF in this enrollee. The 
CardioMEMS device was approved by the FDA in 2014 and consists of a sensor device placed in the 
pulmonary artery to allow measurement of pulmonary artery pressure in the management of enrollees with 
CHF. The clinical study on which FDA approval was based showed improved clinical outcomes and decreased 
hospitalizations in enrollees in whom the CardioMEMS system was implanted, reflecting an enrollee 
population with preserved ejection fraction and was somewhat limited in scope. Subsequent follow-up studies 
remain encouraging and suggest an improvement in heart failure symptoms with the use of the device. In 
addition, published expert opinion in the cardiology literature is supportive of the clinical usefulness of 
CardioMEMS. Nonetheless, there remains a dearth of randomized, blinded clinical studies examining long-
term clinical outcomes establishing the value of CardioMEMS in enrollee management. As a result, at this time 
the CardioMEMS system would not be considered medically appropriate and necessary in this enrollees 
clinical management. 
 
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 not been met. Therefore, we decided that the Plan 
does not have to pre-approve a 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, C2624).