Medicare Coverage Updates
For Tricuspid Transcatheter-Edge-to-Edge Repair (T-TEER)
CMS Releases Final Decision Memo for Tricuspid Transcatheter-Edge-to-Edge Repair (T-TEER)
The TriClip™ System is now covered under a National Coverage Determination (NCD).
On July 2, 2025, the Centers for Medicare and Medicaid Services (CMS) issued a National Coverage Determination to cover tricuspid transcatheter edge-to-edge repair (T-TEER) under Coverage with Evidence Development (CED).
The TriClip System CED Real World Evidence Study (TRICARE) is now approved by CMS for the T-TEER NCD. This means all Medicare beneficiaries, including Medicare Advantage patients previously denied prior authorization may have access to the TriClip System if they meet NCD and CED criteria.
This policy is effective immediately for all dates of service from July 8, 2025 onward.
What You Need to Know
Below are highlights from the final T-TEER NCD:
- T-TEER therapy is covered when furnished according to a Food and Drug Administration (FDA) market-authorized indication: Despite optimal medical therapy (OMT), patients must have symptomatic severe tricuspid regurgitation with tricuspid valve repair being considered as appropriate by a heart team.
- The patient (preoperatively and postoperatively) is under the care of a heart team with experience in the care and treatment of tricuspid regurgitation.
a) Cardiac Surgeon;
b) Interventional Cardiologist;
c) Cardiologist with Training and Experience in Heart Failure Management; and
d) Interventional Echocardiographer.
For Medicare and Medicare Advantage patients receiving the TriClip System, it is important to include the Clinical Trial Number 06920745 and clinical trial coding requirements on all claims.
The final NCD on the CMS website provides all the criteria related to coverage. Additionally, you can visit our reimbursement website for resources such as guides, checklists, reimbursement webinars, and prior authorization resources.
Next Steps for Healthcare Providers
Access these resources provided by Abbott to prepare for the expanded coverage of the TriClip System
for your patients with heart failure.
Sample Claim
Forms
Use these forms to help with billing
claims for the TriClip System.
Questions About the NCD? Contact the Reimbursement Team at Abbott
- Reimbursement Hotline: (855) 569-6430
Contact the Field Reimbursement Team by email
Access reimbursement resources for Coding and Coverage, Prior Authorization and Medicare
- 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 tricuspid transcatheter edge-to-edge repair (T-TEER) when all NCD and Coverage with Evidence Development (CED) criteria are met.
The TriClip 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.
TriClip CED Real World Evidence Study (TRICARE) protocol has been approved by CMS. TRICARE involves CMS claims or clinical data that are collected in the context of healthcare delivery, and the data collection involves no direct patient contact and will not influence the care a patient receives during routine interactions with the healthcare system. Therefore, IRB approvals are unlikely to be required by the hospital. Abbott, being the main entity in the TRICARE study, has requested and been granted a waiver of informed consent and a HIPAA waiver from Western IRB.
- 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 beneficiaries receiving the TriClip System, the NCT number is 06920745.
Read more about the TriClip 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 TriClip™ therapy for more tricuspid regurgitation patients. This means all Medicare beneficiaries, including Medicare Advantage patients previously denied prior authorization may have access to this technology if they meet NCD and CED criteria.
To stay updated on CMS policy and other TriClip TEER updates, please fill out the form below
Reimbursement Contact Information
Reimbursement Hotline
Field Reimbursement Team
MAT-2407762 v3.0 | Item approved for U.S. use only.