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.
Access these Abbott resources to prepare for the expanded coverage of the CardioMEMS HF System for your patients with heart failure.
Stay updated on the latest coverage milestones for the CardioMEMS HF System.
Use this checklist to document patient details for insurance and procedure preparation.
Access reimbursement resources for Coding and Coverage, Prior Authorization Management and Medicare.
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.
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.
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.
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