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 enrollee with chronic ACC/AHA 
stage D heart failure with severely reduced LV systolic function requiring inotropic support with milrinone 0.5 
mcg/kg/min as a bridge to a scheduled Heartmate 3 LVAD implant on March 3, 2023. Surgical and medical 
recommendations to proceed with LVAD implant is a right heart catheterization the day prior to LVAD 
implant to evaluate hemodynamics and allow time for optimization prior to surgery if warranted. 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 guidelines and carries a risk of significant complications including death 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 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 on 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 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).