TriClip™ Transcatheter Edge-to-Edge Repair (TEER) System
Medicare Coverage with Evidence Development Study Information: Professional
This document summarizes the Centers for Medicare & Medicaid Services (CMS) billing requirements for traditional Medicare and Medicare Advantage patients for the TriClip™ TEER System. The system is covered by a National Coverage Determination (NCD) under Coverage with Evidence Development (CED). Physicians are responsible for determining appropriate coding for each patient and procedure, ensuring claims are coded correctly and supported by adequate medical record documentation.
Coding and Reimbursement Information
| CODES/MODIFIERS/OTHERS | CMS REQUIREMENT |
|---|---|
| DIAGNOSIS CODES | |
| Applicable primary diagnosis codes | Yes, in all cases |
| Z00.6*: Encounter for examination for normal comparison and control in clinical research program | Yes, in all cases |
| Applicable secondary diagnosis codes | If applicable |
| CPT CODES | |
| 0569T: Transcatheter tricuspid valve repair percutaneous approach | Yes, in all cases |
| +0570T: Transcatheter tricuspid valve repair percutaneous approach. Additional prosthesis during same session (List separately in addition to code for primary procedure). (Use +0570T in conjunction with 0569T) | If applicable |
| CPT MODIFIERS | |
| -Q0: Investigational/Routine clinical service provided in a clinical research study that is in an approved clinical research study. | Yes, in all cases |
| -62: Use for physician claims for cases where two surgeons/co-surgeons perform TEER. Note that in scenarios where co-surgeon participation is medically necessary, the submission of supporting documentation is required. | If applicable |
| -80/-82: Use for assistant surgeon claims for TEER. Append modifier to assistant surgeon claims; do not append modifier to primary surgeon claims. Use -80 when TEER is performed at non-teaching community hospitals without surgery residents. Use -82 for when TEER is performed at teaching hospitals with surgery residents; -82 indicates qualified surgery resident unavailable. Documentation regarding medical necessity required. | If applicable |
| NCT NUMBER | |
| 06920745* | Yes, in all cases |
*These are requirements because of the CED.
Sample Professional Claim Form Information
The document includes an example of a CMS-1500 Professional Claim Form for illustrative purposes. Key information highlighted includes:
- Item 19 (Additional Claim Information): Used for reporting additional claim information or Prior Authorization numbers. For example, it shows how to report CPT code 0569T as a crosswalk to CPT code 33418, and CPT code 0570T as a crosswalk to CPT code 33419. The NCT number (e.g., CT06920745) is reported here, with a specific format for paper versus electronic claims.
- Item 24 (Procedures, Services, or Supplies): Details the service lines, including CPT/HCPCS codes (0569T, 0570T), modifiers (Q0), dates of service, and charges.
- Item 25 (Physician or Supplier Information): Includes signature and date.
- Item 28 (Total Charge): The total charges for the services.
- Item 29 (Amount Paid): Not explicitly shown but implied for payment tracking.
- Item 31 (Billing Provider Info & PH): Placeholder for billing provider details.
The example emphasizes that charges for the TriClip procedure codes should be comparable to the charges for the selected crosswalk CPT codes.
Important Safety Information: TriClip™ G5 System
Brief Summary: Users should review the Instructions for Use (IFU) for comprehensive details on indications, contraindications, warnings, precautions, potential adverse events, and directions for use.
Rx Only: This device is intended for use by or under the direction of a physician.
Indications and Usage: The TriClip™ G5 System is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation who are at intermediate or greater risk for surgery, and for whom transcatheter edge-to-edge valve repair is clinically appropriate. The goal is to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.
Contraindications: The system is contraindicated for patients with:
- Intolerance, including allergy or untreatable hypersensitivity, to procedural anticoagulation.
- Untreatable hypersensitivity to implant components (nickel-titanium alloy, cobalt-chromium alloy).
- Active endocarditis or other active infection of the tricuspid valve.
Potential Adverse Events: Possible complications include, but are not limited to:
- Allergic reactions or hypersensitivity (latex, contrast agent, anesthesia, device materials, drugs).
- Additional treatment or surgery for device-related complications.
- Bleeding disorders (e.g., coagulopathy, hemolysis, Heparin Induced Thrombocytopenia).
- Cardiac arrhythmias.
- Cardiac ischemic conditions (e.g., myocardial infarction, ischemia, unstable angina).
- Cardiac perforation or tamponade.
- Chest pain, Death, Dyspnea, Edema.
- Embolization (device or components).
- Endocarditis, Fever or hyperthermia.
- Fluoroscopy and TEE-related complications (skin injury, esophageal irritation/perforation, GI bleeding).
- Hypotension/hypertension, Infection (e.g., septicemia).
- Nausea or vomiting, Pain.
- Pericardial effusion, Stroke/CVA, Transient ischemic attack (TIA).
- System organ failure (cardio-respiratory arrest, worsening heart failure, pulmonary congestion, respiratory dysfunction/failure, renal insufficiency/failure, shock).
- Thrombosis.
- Tricuspid valve complications (e.g., chordal entanglement/rupture, single leaflet device attachment, dislodgement, tissue damage, stenosis, worsening regurgitation).
- Vascular access complications (e.g., wound dehiscence, bleeding, fistula, pseudoaneurysm, aneurysm, dissection, perforation, occlusion, embolism, peripheral nerve injury).
- Venous thrombosis (including DVT) and thromboembolism (including pulmonary embolism).
References
- National Coverage Determination TriClip: NCA - Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER) (CAG-00468N) - Decision Memo: CMS Coverage with Evidence Development
- 2025 ICD-10-PCS: CMS ICD-10-PCS Coding Guidelines
- 2025 ICD-10-CM: CMS ICD-10-CM Coding Guidelines
- Coverage with Evidence Development: CMS Coverage with Evidence Development
- CMS MLN Matters MM8401 Mandatory Reporting of 8-Digit Clinical Trial Number on Claims: CMS MLN Matters MM8401
- CPT Copyright 2025 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association: AMA CPT Information
- Physician Prospective Payment Final rule with comment period and final CY2025 Payment Rates. CMS-1807-F: CMS Physician Payment Rule
- National Correct Coding Initiative Edits: CMS NCCI Edits
- Medicare Claims Processing Manual Chapter 32: Medicare Claims Processing Manual
- CMS UB-04 Form: CMS UB-04 Form Information
- CMS-1500 Paper Form: CMS-1500 Paper Form Information
- D4 Value Code for Institutional Claim Form UB-04: CMS Value Code Information
Important Information and Disclaimer
CAUTION: Product(s) intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use (IFU) for detailed information on Indications, Contraindications, Warnings, Precautions, and Adverse Events.
Disclaimer: This material is for general information purposes only and does not constitute legal, reimbursement, business, clinical, or other advice. Abbott does not guarantee reimbursement, payment, or charge receipt, nor does it warrant the completeness or accuracy of the codes and narratives provided. The ultimate responsibility for coding, claims submission, and reimbursement lies with the customer. Customers should consult with local carriers, intermediaries, legal counsel, or financial/coding specialists regarding any questions, as laws, regulations, and policies are subject to frequent updates.
Information is for DISTRIBUTION in the U.S. ONLY.
