Implantable Pulmonary Artery Pressure Sensors for Heart Failure Management

CMS covers implantable pulmonary artery pressure sensors for heart failure management only within CMS‑approved Coverage with Evidence Development (CED) studies and only when the patient meets defined clinical criteria (chronic HF ≥3 months, NYHA II–III within 30 days, recent HF hospitalization or elevated natriuretic peptides, GDMT ≥3 months, appropriate ICD/CRT evaluation/implantation, no major CV event in prior 3 months, reliable connectivity, and not implanted during an acute HF admission). Practitioners must meet specified training requirements and CED protocols must include defined primary outcomes with ≥24 months follow-up, an active comparator, care management plans, measures of clinical utility, subgroup analyses, and adherence to AHRQ/CMS scientific standards; IPAPS is not covered outside these parameters except via alternative regulatory pathways (NCD 310.1 or IDE).

"Implantable pulmonary artery pressure sensors (IPAPS) are covered when furnished according to an FDA market-authorized indication and all CMS-specified conditions are met."