MM14149 - National Coverage Determination 20.37: Transcatheter Tricuspid Valve Replacement

=== Page 1 === m!n MATTERS® KNOWLEDGE • RESOURCES • TRAINING # National Coverage Determination 20.37: Transcatheter Tricuspid Valve Replacement | Related CR Release Date: September 22, 2025 | MLN Matters Number: MM14149 Revised | | --- | --- | | Implementation Date: January 5, 2026 | Related CR Transmittal Numbers: R13343CP, R13343NCD, R13427CP & R13427NCD | What's Changed? We made no substantive changes to the article other than to update the CR release date, transmittal numbers, and transmittal links. # Affected Providers - Physicians - Hospitals # Action Needed Make sure your billing staff knows about national coverage of transcatheter tricuspid valve replacement (TTVR): - Criteria - Coverage with evidence development (CED) study criteria - Claims processing requirements CPT codes, descriptions, and other data only are copyright 2024 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. CPT is a registered trademark of the American Medical Association. CMS CENTER FOR MEDICINE & MEDICINE SURVEYS Medicare Learning Network === Page 2 === MLN Matters: MM14149 # Key Updates ## Nationally Covered Indications TTVR treats tricuspid regurgitation (TR). Effective March 19, 2025, CMS covers TTVR for treating symptomatic TR under CED according to the coverage criteria we outline in the Medicare National Coverage Determination (NCD) Manual, Chapter 1, section 20.37. ## Patient Criteria Patients must have symptomatic TR despite optimal medical therapy, and their heart team must consider tricuspid valve replacement as an appropriate treatment. ## Physician Criteria The patient is under the care of a heart team (preoperatively and postoperatively), which includes, at a minimum: - Cardiac surgeon - Interventional cardiologist - Cardiologist with training and experience in heart failure management - Electrophysiologist - Multi-modality imaging specialist - Interventional echocardiographer All the specialists above must have experience caring for and treating TR. CMS CONSULTING MOBILIMS & MEDICINE SERVICES === Page 3 === MLN Matters: MM14149 # CED Study Criteria The heart team must provide TTVR items and services in the context of a CMS-approved CED study. Study protocols must: - Include only those patients who meet the patient criteria in NCD 20.37 - Provide items and services only through practitioners who meet the physician criteria in NCD 20.37 - Include: - Primary outcomes of all-cause mortality, hospitalizations, or a composite of these through a minimum of 24 months. For composite outcome measures, physiological, patient-reported, and other relevant health outcomes should be co-directional (all outcomes comprising the composite outcome should demonstrate movement in the same direction). A practitioner on the heart team must individually report each component of a composite outcome. - An active comparator. - A care management plan that includes the experience and role of each member of the heart team described in NCD 20.37. - A design sufficient for subgroup analyses by: - Age - Sex - Race and ethnicity - Practitioner- and facility-level variables that predict the primary outcome of the study - Left ventricular ejection fraction (by guideline-defined subgroups) - Previous tricuspid surgery or intervention - Severe aortic or mitral stenosis or regurgitation - Patients with chronic kidney disease - Patients with indwelling cardiac implantable electronic devices Note: Consistent with section 1142 of the Social Security Act, AHRQ supports clinical research studies that we determine meet all the criteria and standards identified. Medicare Learning Network === Page 4 === MLN Matters: MM14149 ## Other Uses of TTVR - We don't cover TTVR for patients outside of a CMS-approved study - Nothing in this NCD would preclude coverage of TTVR through NCD 310.1 (Clinical Trial Policy) or through the investigational device exemption policy ## Claims Processing Requirements Bill the following procedure codes for TTVR: - ICD-10-PCS code X2RJ3RA — Replacement of Tricuspid Valve with Multi-plane Flex Technology Bioprosthetic Valve, Percutaneous Approach, New Technology Group 10 - ICD-10-PCS code 02RJ38Z — Replacement of Tricuspid Valve with Zooplastic Tissue, Percutaneous Approach Submit claims for TTVR with 1 of these ICD-10-CM diagnosis codes as principal diagnosis code—I07.1, I07.2, I08.1, I08.2, I08.3, I36.1, I36.2, or Q22.8—and Z00.6 as other diagnosis code. ## Professional Claims We cover claims for TTVR in a clinical research study when billed with: - Modifier Q0 — Investigational clinical service provided in a clinical research study that's in an approved clinical research study - Appropriate ICD-10-CM principal diagnosis code and ICD-10-CM diagnosis code Z00.6 as other diagnosis code ## Institutional Claims Inpatient hospitals must bill for TTVR on type of bill (TOB) 11X. We cover claims for TTVR when billed with: - ICD-10-PCS code X2RJ3RA or 02RJ38Z - Condition code 30 — Qualified clinical trial - Value code D4 — Clinical trial number (8-digit number) If you provide TTVR to a Medicare Advantage (MA) plan patient, you must also report condition code 04. MA organizations are responsible for payment. CPT only copyright 2024 American Medical Association. All Rights Reserved. CMS COMMUNICATIONS & MEDICINE SERVICES === Page 5 === MLN Matters: MM14149 Your Medicare Administrative Contractor (MAC) will return any TTVR claims you submitted with the wrong TOB, claims without the appropriate condition code or value code, or claims not including the clinical trial number. If you perform other procedures at the same time as TTVR, we'll apply our current payment guidelines to those services. Note: Your MAC won't search their files for TTVR claims processed with dates of service from March 19, 2025 – January 5, 2026; however, they'll adjust any claims that you bring to their attention. ## More Information - R13343CP - R13343NCD - R13427CP adds section 413 to the Medicare Claims Processing Manual, Chapter 32 - R13427NCD adds section 20.37 to the Medicare NCD Manual, Chapter 1, Part 1 For more information, find your MAC's website. ## Document History | Date of Change | Description | | --- | --- | | September 23, 2025 | We made no substantive changes to the article other than to update the CR release date, transmittal numbers, and transmittal links. | | August 1, 2025 | Initial article released. | View the Medicare Learning Network® Content Disclaimer and Department of Health & Human Services Disclosure. The Medicare Learning Network®, MLN Connects®, and MLN Matters® are registered trademarks of the U.S. Department of Health & Human Services (HHS). Medicare Learning Network

Medically necessary for patients with symptomatic severe tricuspid regurgitation who are not suitable candidates for surgical intervention. Coverage for transcatheter tricuspid valve replacement (TTVR) is established. Criteria must be met for coverage with evidence development (CED) studies. TTVR is covered for treating symptomatic tricuspid regurgitation (TR) when patients have TR despite optimal medical therapy. TTVR items and services are covered in the context of a CMS-approved CED study. Patient criteria must meet the specifications outlined in NCD 20.37. Services must be provided by practitioners who satisfy NCD 20.37 physician criteria. Left ventricular ejection fraction is assessed by guideline-defined subgroups. Indications include previous tricuspid surgery or intervention. Severe aortic or mitral stenosis or regurgitation is included as a covered indication. Patients with chronic kidney disease are eligible. Patients with indwelling cardiac implantable electronic devices may also qualify. CMS-approved CED studies must adhere to the scientific standards identified by the AHRQ. TTVR is covered when it is performed as part of a CMS-approved study. Coverage is allowed for TTVR through NCD 310.1 (Clinical Trial Policy) or through the investigational device exemption policy. TTVR is covered with principal diagnosis codes I07.1, I07.2, I08.1, I08.2, I08.3, I36.1, I36.2, or Q22.8, and Z00.6 as other diagnosis code. Claims for TTVR in clinical research studies are covered with specific HCPCS codes and modifiers. TTVR is covered when provided to Medicare Advantage plan patients.

Not covered for patients with active infection or significant co-morbid conditions that may affect surgical outcomes. Coverage is limited to facilities participating in approved clinical trials. Outcomes must include all-cause mortality, hospitalizations, or a composite thereof for a minimum of 24 months. Study design must allow for subgroup analyses by age, sex, race and ethnicity, and practitioner- and facility-level variables. TTVR is not covered for patients outside of a CMS-approved study. Institutional claims for TTVR must be billed on type of bill (TOB) 11X. Claims will not be covered if not billed with appropriate diagnosis codes and clinical trial identifiers. Payment responsibility falls on MA organizations. Claims submitted with the wrong type of bill (TOB) will be returned. Claims without the appropriate condition or value code will not be processed. Claims not including the clinical trial number will not be paid.

Clinical documentation must include evidence of symptoms related to tricuspid regurgitation and rationale for the use of transcatheter valve replacement. Prior authorization is required along with imaging studies confirming diagnosis. Claims processing requirements must be followed. Billing staff must be trained on the coverage criteria. The patient must be under the care of a heart team which includes a cardiac surgeon, interventional cardiologist, cardiologist specializing in heart failure, electrophysiologist, multi-modality imaging specialist, and interventional echocardiographer. Study protocols must be adhered to for coverage eligibility. Care management plan detailing the experience and role of each heart team member. Each component of composite outcomes must be individually reported by a heart team practitioner. Clinical trial identifier number must accompany claims. ICD-10-CM diagnosis codes must be documented accurately. Condition code 04 must be reported when TTVR is provided.