CardioMEMS HF System Coverage Available for Medicare and Medicare Advantage
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).
The CardioMEMS™ HF System CED study is approved by CMS for the IPAPS NCD. Medicare beneficiaries, including previously denied Medicare Advantage patients, will have access to the CardioMEMS HF System when policy criteria is met.
View Frequently Asked Questions about the NCD & CardioMEMS Reimbursement
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.
Transmittal Support Resource
This resource provides formal guidance from CMS supporting the NCD.
Clinical
Checklist
Use this checklist to document patient details for insurance and procedure preparation.
Sample
Claim Forms
Use these forms to help with billing claims for the CardioMEMS HF System.
Frequently Asked Questions
What is a National Coverage Determination (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.
The CED protocol for the CardioMEMS HF System has been approved by CMS.
What is a National Clinical Trial (NCT) number?
The NCT number is a unique identifier that enables real-world reporting for the CED. For Medicare and Medicare Advantage beneficieries receiving the CardioMEMS HF System, the NCT number is 06779552.
Read more about the CardioMEMS HF System CED study on ClinicalTrials.gov.
Physicians and implanting facilities must include study information, including the NCT number, on all claim forms to reduce risk of denial.
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. When policy criteria is met, CardioMEMS HF System can be performed in the inpatient, outpatient or ambulatory surgery centers (ASC) settings.
What can I do to enroll my patient in the CED study?
Physicians and facilities will be required to add the CED study information to their claim forms. There will be no additional reporting requirements for the CED outside of standard documentation.2
Impact on Practices and Patients
What should practices do about patients who were previously denied?
Practices can review the updated NCD criteria to determine if previously denied patients may now qualify for CardioMEMS under the new coverage criteria.1
What are the key patient selection criteria under the NCD?
Read more about the updated coverage criteria under the implantable pulmonary artery pressure sensor(s) NCD at the official announcement by the CMS .
Will commercial payors follow the NCD criteria?
Many commercial payers tend to follow CMS decisions, and may eventually adopt similar policies, but they take time to do so. Practices will need to check with individual payers for updates.1
References:
1Medicare Coverage Determination Process: Medicare Coverage Determination Process | CMS
2Coverage with Evidence Development: Coverage with Evidence Development | CMS
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.
Determine if your heart failure patient might be indicated for the CardioMEMS HF System with the Patient Indication Quiz.
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