Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management

Heart failure (HF) is a chronic syndrome that impairs the ability of the ventricle to fill with or eject blood. Symptoms, including fatigue and shortness of breath, limit an individual’s ability to engage in everyday activities such as walking or climbing stairs. Chronic stable HF can worsen and progress into acutely decompensated HF (ADHF), a condition characterized by congestion, fluid retention, and sometimes as inadequate cardiac output. The standard of care for monitoring fluid status in chronic HF in the outpatient setting involves monitoring changes in HF signs and symptoms, including changes in body weight and blood pressure. Pulmonary artery (PA) pressure measurements can provide information regarding fluid status. The type of device examined in this NCA measures PA pressure using a combination of an implantable PA pressure sensor and a remote hemodynamic monitoring system that is accessible by physicians.

CMS received a complete, formal request to provide coverage for the CardioMEMS HF System.

This NCA will focus on the clinical indications for use of implantable PA pressure sensors for HF management among Medicare beneficiaries. This NCA will analyze clinical evidence for characteristics or comorbidities that make patients more or less likely to benefit from the device as well as whether there are specific treatment conditions necessary to achieve the outcomes demonstrated in clinical studies. Other outcomes of interest may include decreased mortality, decreased frequency of exacerbations requiring emergency room or hospital admission, increased time to hospital re-admission for HF complications, improved function, and quality of life. The scope of this NCA is limited to implantable PA pressure sensors for HF management.

CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence, specifically any peer-reviewed literature, that describes the role of implantable PA pressure sensors for HF management. We are also interested in aspects of health disparities and health equity that should be considered in the review.

April 30, 2024