Expanded Access for the CardioMEMS HF System

CMS National Coverage Determination Covers Implantable Pulmonary Artery Pressure Sensors for Heart Failure Management Under Coverage with Evidence Development

Expanded Access for the CardioMEMS HF System

The CardioMEMS HF System is now covered under a National Coverage Determination (NCD)

On January 13, 2025, the Centers for Medicare and Medicaid Services (CMS) issued a National Coverage Determination to cover implantable pulmonary artery pressure sensors (IPAPS) for heart failure management under Coverage with Evidence Development (CED). An NCD with CED indicates that Medicare wants to collect data on the technology. Once CMS approves the CED study, all Medicare beneficiaries, including previously denied Medicare Advantage patients, may have access to the CardioMEMS™ HF System.

View more details about the NCD here.  

Next Steps for Healthcare Providers

Access these Abbott resources to prepare for the expanded coverage of the CardioMEMS HF System for your patients with heart failure.

NCD updates

Stay updated on the latest coverage milestones for the CardioMEMS HF System.

Get notified

Clinical Checklist

Use this checklist to document patient details for insurance and procedure preparation.

CardioMEMS checklist

Questions About the NCD? Contact the Abbott Reimbursement Team

  • Reimbursement Hotline: (855) 569-6430
  • Contact the Field Reimbursement Team by email

Access reimbursement resources for Coding and Coverage, Prior Authorization Management and Medicare.

Reimbursement information

What is a National Coverage Determination (NCD)?

A National Coverage Determination (NCD) is a Medicare policy that covers a specific medical item or service nationally. CMS now covers implantable pulmonary artery pressure sensors for heart failure management when all NCD and Coverage with Evidence Development (CED) criteria are met.

The CardioMEMS HF System will now have expanded coverage through this NCD.

What is Coverage with Evidence Development (CED)?

Coverage with Evidence Development (CED) is a clinical study requirement to provide coverage. CED helps gather data to fill evidence gaps for certain medical items and services.​

Abbott has submitted a CED study protocol to CMS for the CardioMEMS HF System. Once approved, a National Clinical Trial number (NCT) will be used to track participation in the CED.

What is a National Clinical Trial (NCT) number?

The NCT number is a unique identifier that enables real-world reporting for the CED. Physicians and implanting facilities must include study information, including the NCT number, on all claim forms to reduce risk of denial. Once assigned, the NCT number is available on the ClinicalTrials.gov website.

What will an NCD mean in real-world practice?

The NCD expands access to the CardioMEMS HF System for more heart failure patients. This means all Medicare beneficiaries, including previously denied Medicare Advantage patients, may have access to this technology if they meet NCD and CED criteria. Coverage under the new NCD is effective immediately after the CED study protocol is approved by the CMS for the CardioMEMS HF System.

Resources for Cardiologist and Implanting Facilities

reimbursement hotline
Reimbursement
Hotline
Call for Patient Therapy Access
Patient Therapy Access for CardioMEMS
Email us
Field Reimbursement Team

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