Implantable Pulmonary Artery Pressure Sensors for Heart Failure Management

On January 13, 2025, CMS issued an NCD that covers FDA approved Implantable Pulmonary Artery Pressure Sensors (IPAPS) for Heart Failure (HF) Management under Coverage with Evidence Development (CED), when furnished in accordance with the coverage criteria specified in the NCD. The complete NCD decision memorandum is available on our website (see link below).

https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=313&doctype=all&timeframe=30&sortBy=updated&bc=21

Below is a list of studies that have been determined to meet the requirements for coverage under CED.

Study Title: CED CardioMEMS HF System Coverage with Evidence Development Study
Sponsor: Abbott 
Clinicaltrials.gov number: NCT06779552
CMS Approval Date: 02/07/2025

Study Title: The ReaL-WOrld Effectiveness of The COrdella Pulmonary Artery (PA) Sensor System in Patients With Chronic HEart FailuRe: A ComParative Analysis to Standard of Care Pharmacologic Therapy (LOWER-PAP)
Sponsor: Edwards Lifesciences
Clinicaltrials.gov number: NCT06783335
CMS Approval Date: 2/7/2025