EXPERIMENTAL/INVESTIGATIONAL
In accordance with Medicare, implantation of a pulmonary artery pressure sensor (PAPS) for heart failure management (e.g. CardioMEMS Heart Failure System, Cordella™ Pulmonary Artery (PA) Pressure Sensor System) is considered experimental/investigational and, therefore, not covered, with the exception of Coverage with Evidence Development (CED).
COVERAGE WITH EVIDENCE DEVELOPMENT (CED)
Implantation of an PAPS for heart failure management when furnished in accordance with the US Food and Drug Administration (FDA)–labeled indication and intended purpose will be covered under Medicare's Coverage with Evidence Development (CED) when individuals are enrolled in a clinical study that fulfills ALL of the requirements as stated in Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) for Implanted Pulmonary Artery Pressure Sensor for Heart Failure Management (CAG-00466N) and when ALL of the following conditions are met:
- The individual has a diagnosis of chronic heart failure (HF) of at least 3 months duration and in New York Heart Association (NYHA) functional Class II or III within the past 30 days, prior to PAPS implantation, regardless of left ventricular ejection fraction (LVEF).
- The individual has a history of HF hospitalization or urgent HF visit (emergency room or other outpatient visit requiring intravenous diuretic therapy) within the past 12 months, or elevated natriuretic peptides within the past 30 days.
- The individual is on maximally tolerated guideline-directed medical therapy (GDMT) for at least 3 months prior to PAPS implantation.
- The individual is evaluated for, and received if appropriate, an implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT)-Pacemaker (CRT-P), or CRT-Defibrillator (CRT-D). Implantation of the device must occur at least 3 months prior to PAPS implantation.
- The individual has had no major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke) within the last 3 months prior to PAPS implantation.
- The individual has access to reliable connectivity to ensure daily collection and submission of IPAPS data.
- The individual must not have PAPS implantation occur during a hospital admission for an acute HF episode.
- The IPAPS items and services are furnished by practitioners who meet the following criteria, as applicable:
- Physicians referring individuals and managing them post implantation must be cardiologists with experience in advanced HF management.
- Physicians implanting a PAPS must have advanced training and experience in pulmonary arterial catheterization and intervention.
REQUIRED DOCUMENTATION
The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.
The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
BILLING REQUIREMENTS
Claims for implantation of a PAPS for heart failure management for individuals enrolled in a CED clinical study should be submitted to the Medicare Advantage plan.
Providers must report Modifier Q0 with procedure codes 33289, 93264, C2624, G0555 to represent investigational clinical service provided in a Centers for Medicare & Medicaid Services (CMS) approved clinical research study.
