Prior authorization request form Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM EFFECTIVE DATE: 04|01|2026 POLICY LAST REVIEWED: 12|17|2025 OVERVIEW Transcatheter tricuspid valve repair or replacement is an emerging alternative to surgical therapy for patients with severe tricuspid regurgitation (TR), particularly those at elevated surgical risk. TR may result from a primary structural abnormality of the tricuspid valve or, more commonly, from secondary annular dilation and leaflet tethering due to right ventricular remodeling associated with left-sided heart failure, pulmonary hypertension, or atrial fibrillation. Surgical intervention for isolated TR is often underutilized due to high perioperative risk and limited referral, highlighting a substantial unmet need for less invasive treatment options.
This policy is applicable for Commercial Products only. For Medicare Advantage Plans, see Related Policies section. This policy addresses the following procedures: • Transcatheter Tricuspid Valve Edge-to-Edge Repair (T-TEER), CPT Code 0569T • Transcatheter Tricuspid Valve Repair (TTVR), CPT Code 0646T MEDICAL CRITERIA Not applicable PRIOR AUTHORIZATION Not applicable
POLICY STATEMENT Commercial Products T-TEER and TTVR are considered not medically necessary as the evidence is insufficient to determine the effects of the technology on health outcomes. For Medicare Advantage Plans, refer to the Related Policies section. COVERAGE Benefits may vary between groups/contracts. Please refer to the Evidence of Coverage or Subscriber Agreement for applicable surgery benefits/coverage. BACKGROUND Tricuspid Regurgitation Tricuspid regurgitation (TR) refers to the backward flow of blood through the tricuspid valve due to inadequate closure of the valve during systole and is the most common indication requiring tricuspid valve repair or replacement. TR may be classified as primary, due to intrinsic abnormalities of the valve apparatus, or more commonly secondary (functional), caused by right ventricular remodeling and annular dilation. Common etiologies include pulmonary hypertension, left heart disease, atrial fibrillation, and the presence of cardiac implantable electronic devices. Clinically significant TR is common in older adults, affecting approximately4% of individuals over age 75 and up to 7% of those over 65, with a higher prevalence in DRAFT Medical Coverage Policy | Transcatheter Tricuspid Valve Repair or Replacement (T-TEER or TTVR)

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

women. TR has been observed to be independently associated with increased mortality, heart failure hospitalizations, and reduced quality of life, even in moderate forms.

Treatment Historically, treatment options for TR were limited to diuretics for symptom relief or surgical intervention in conjunction with other valve procedures. According to the current American College of Cardiology and the American Heart Association guidelines (ACC/AHA), the only Class 1 surgical indication for treating TR is inpatients undergoing left-sided valve surgery; with all isolated surgeries having a class 2 level of evidence. Isolated surgical tricuspid repair or replacement has been associated with high perioperative mortality of up to 10% and is infrequently pursued. Many patients are deemed inoperable due to frailty, comorbidities, or advanced disease. Until recently, there were no approved minimally invasive therapies specifically indicatedfor TR, leaving a large proportion of patients untreated and symptomatic despite maximal medical therapy. The emergence of transcatheter tricuspid valve interventions offers an alternative treatment with two modalities that have gained regulatory approval in the United States: transcatheter edge-to-edge repair (T-TEER) and transcatheter valve replacement (TTVR).

Regulatory Status The EvoqueTM Tricuspid Valve Replacement System (Edwards Lifesciences, Co.) and the TriClipTM G4 System (Abbott Medical) are currently the only FDA-approved devices for tricuspid valve replacement and repair. Several additional devices, the PASCALTM Transcatheter Valve Repair System, a transcatheter edge- to-edge repair device similar to TriClip, and the CardiobandTM Tricuspid Valve Reconstruction system, an annuloplasty device, both by Edwards Lifesciences, have received CE marking but have not yet been FDA approved. The focus of this review will be on devices that have FDA approval.

TriClip G4 System The TriClip G4 System, manufactured by Abbott, was granted FDA Premarket Approval (PMA) on April 1,

2024. The device is indicated for, “improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.” TriClip is derived from the MitraClip system, which served as its predicate device under compassionate use for tricuspid regurgitation. The technology adapts MitraClip’s TEER for use in the tricuspid position, providing a repair-based alternative to valve replacement.

      Post-approval, TriClip is subject to two Post-Approval Studies (PAS). Continued Follow-up of the Premarket Cohort, which monitors Investigational Device Exemption (IDE) and Continued Access Protocol patients through 5 years, tracking clinical outcomes including mortality, TR grade, reintervention, New York HeartAssociation (NYHA) class, 6 minute walk test (6MWT), and quality-of-life metrics (KCCQ, SF-36). And a registry-based study involving 5,000 patients or all treated in the first 2 years, with a detailed subgroup of 1,000 patients tracked for 1-year outcomes. Data from years 2 to 5 will be supplemented via Centers for Medicare & Medicaid Services (CMS) claims, and a minimum enrollment of 100 patients per underrepresented racial/ethnic group is mandated.

      EVOQUE Tricuspid Valve Replacement System The Edwards EVOQUE Tricuspid Valve Replacement System received PMA from the FDA on February 1,2024. The approved indication for use is, “the improvement of health status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, for whom tricuspid valve replacement is deemed appropriate by a heart team.” The EVOQUE system is a TTVR device, and, unlike repair devices, it does not rely on annular or leaflet anatomy for efficacy, making it suitable for patients in whom repair is not feasible. The FDA has imposed several post-approval requirements, most notably a registry-based study. This study will enroll at least 5,000 consecutively treated patients (or all patients treated within the first 2 years of approval, whichever is greater) into the Society of Thoracic Surgeons and the American College of Cardiology

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

(STS/ACC) Transcatheter Valve Therapy Registry. Data will be collected for at least five years post- procedure, with one-year outcomes sourced from the registry and longer-term data linked to CMS claims. A focus of the study is on underrepresented populations, requiring at least 100 patients from each racial/ethnic group, including Black, Asian, Native American, Pacific Islander, and Hispanic/Latino patients.

Tricuspid valve repair or replacement via transcatheter approach devices are in early stages of development for the treatment of tricuspid regurgitation. There are small case series as well as ongoing clinical trials for patients with diseased tricuspid valves undergoing transcatheter tricuspid valve replacement. There is currently insufficient published evidence to assess the safety and/or impact on health outcomes of transcatheter tricuspid valve replacement in patients with diseased tricuspid valves.

Most recently, Kodali et al. (2023) published one year outcomes from the TRISCEND study which evaluates the safety and performance of the EVOQUE tricuspid valve (TV) replacement system (Edwards Lifesciences, Irvine, CA) in patients with moderate and greater symptomatic TR despite medical therapy. This global, prospective, single-arm, multicenter TRISCEND study enrolled 176 patients who were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III–IV. Major adverse events, reduction in TR grade and hemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure. The study showed in elderly, highly comorbid population receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. This study has several limitations including being funded by Edwards Lifesciences with a single-arm design and no comparison to standard of care. This is an interim analysis, and not all enrolled patients had yet reached their one-year follow-up. TTVR is an evolving field and standardized criteria for data collection and clinical trial definitions continue to develop. The evidence is insufficient to determine the effects of the technology on health outcomes.

CODING Commercial Products The following CPT code(s) are considered not medically necessary:
0569T Transcatheter tricuspid valve repair, percutaneous approach; initial prosthesis 0570T Transcatheter tricuspid valve repair, percutaneous approach; each additional prosthesis during same session (List separately in addition to code for primary procedure) 0646T Transcatheter tricuspid valve implantation (TTVI)/replacement with prosthetic valve, percutaneous approach, including right heart catheterization, temporary pacemaker insertion, and selective right ventricular or right atrial angiography, when performed

RELATED POLICIES Medicare Advantage Plans National and Local Coverage Determinations

PUBLISHED Provider Update, February 2026

REFERENCES

1. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD), Transcatheter Tricuspid Valve Replacement (TTVR) (20.37).
2. Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD), Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER) (20.38).

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 4 (401) 274-4848 WWW.BCBSRI.COM

3. Alperi AA, et al. Early and mid-term outcomes of transcatheter tricuspid valve repair: systematic review and meta-analysis of observational studies. Rev Esp Cardiol (Engl Ed). 2022 Jun:S1885-5857.
4. Asmarats L, et al. Transcatheter tricuspid valve replacement for treating severe tricuspid regurgitation: initial experience with the NaviGate bioprosthesis. Can J Cardiol. 2018;34(10):1370.e1375-1370.e1377.
5. Blasco-Turrión S, et al. Bicaval TricValve implantation in patients with severe symptomatic tricuspid regurgitation. JACC Cardio Interv. 2024 Jan;17(1):60-72.
6. Curio J et al. Update on the current landscape of transcatheter options for tricuspid regurgitation treatment. Interv Cardiol. 2019 May;14(2): 54–61.
7. Hahn RT, et al. Early single-site experience with transcatheter tricuspid valve replacement. JACC Cardiovasc Imaging. 2019;Mar;12(3):416-429.
8. Kodali S, et al. Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study. Eur Heart J. 2023 Dec;44(46):4862-4873.
9. National Institute for Health and Care Excellence (NICE) [Internet]. Transcatheter tricuspid valve leaflet repair for tricuspid regurgitation, Interventional procedures guidance (IPG731), 2022 July 27 [accessed 2025 Feb 25]. Available from: https://www.nice.org.uk/guidance/ipg731
10. Nickenig G, et al. 6-Month outcomes of tricuspid valve reconstruction for patients with severe tricuspid regurgitation. J Am Coll Cardiol. 2019;73(15):1905.
11. Ranocchi F1, et al. Minimally invasive implantation of a Sapien 3 Ultra Valve in a degenerated tricuspid bioprosthesis. J Card Surg. 2020 Jun;35(6):1371-1374.
12. Ruf TF, et al. Short-term clinical outcomes of transcatheter tricuspid valve repair with the third generation MitraClip XTR System. J Am Coll Cardiol Intv. Jun 2021;14(1):1231-40.

13. Taramasso M, et al. Outcomes after current transcatheter tricuspid valve intervention: mid-term results from the International TriValve Registry. JACC Cardiovasc Interv. 2019;Jan 28;12(2):155-165.

    i ii

    This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association.

    CLICK THE ENVELOPE ICON BELOW TO SUBMIT COMMENTS