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) and an implantable wireless pulmonary artery 
pressure sensor with delivery catheter, including all system components (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 the CardioMEMS device has been determined to be of uncertain value 
in the most recent 2022 ACC/AHA/HFSA Guidelines and carries a risk of significant complications including 
deather and severe pulmonary artery injury. The CardioMEMS device at this point should only be approved for 
enrollees enrolled in a clinical trial. There is no indication that this enrollee is enrolled in a clinical trial of the 
device. 
 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 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 the enrollee's 
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) and an implantable wireless pulmonary artery 
pressure sensor with delivery catheter, including all system components (C2624).