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 (33289). 
 
You asked the Plan to pre-approve a CardioMEMS HF System. You say that the device is medically necessary. 
The CardioMEMS HF System is FDA approved for wirelessly measuring and monitoring pulmonary artery 
pressure in New York Heart Association (NYHA) Class II & III HF patients with a prior HF hospitalization in 
the past year or an elevated BNP /pro-NT BNP.1. The Plan denied your request. The Plan says the enrollee has 
demonstrated problems with medication noncompliance. His recurrent heart failure admissions may not be 
reduced by the CardioMEMS device. Therefore, it is not at all clear that a CardioMEMS is medically necessary 
for the enrollee. 
 
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 HF System. 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 a patient 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 patient management. 
As a result, at this time the CardioMEMS system would not be considered medically appropriate and necessary 
in the 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 HF System 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 (33289).