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Transcatheter Cardiac Valve Procedures
MA11.027h

Policy

This policy uses coverage criteria developed solely based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents.​

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. 
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TRANSCATHETER AORTIC VALVE REPLACEMENT

MEDICALLY NECESSARY
Transcatheter aortic valve replacement (TAVR) is considered medically necessary and, therefore, covered for symptomatic severe aortic valve stenosis (or aortic stenosis [AS]) when ALL of the following conditions are met:
  • The procedure is furnished with a complete aortic valve and implantation system that has received US Food and Drug Administration (FDA) premarket approval (PMA) for that system's FDA-approved indication.
  • The individual (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multidisciplinary team of medical professionals with a specialized focus in cardiac care. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal individual-centered care. Heart teams include the following:
    • ​At least one cardiac surgeon and one interventional cardiologist experienced in the care and treatment of aortic valve diseases and each with clinical privileges at the hospital where the TAVR will be furnished; and
    • Advanced practice clinicians, nurses, administrators and, as needed, members from other physician specialties and research personnel.
  • Suitability for surgical aortic valve replacement (SAVR), TAVR, close surveillance, and palliative care must be evaluated based on individual clinical, anatomical, and procedural characteristics, and lifetime management considerations that account for individual life expectancy. These evaluations must be documented and made available to other heart team members, the individual, and other clinicians involved in the individual's care as appropriate, prior to the day of the procedure. Evaluations must include:
    • ​An initial evaluation by the heart team, which could be asynchronous using medical records to identify individual suitability for TAVR or other treatments, and includes input from both cardiac surgery and interventional cardiology; and
    • An in-person evaluation by a heart team TAVR operator. This cannot be satisfied through a virtual encounter.
  • ​The professional and facility providers meet ALL the requirements as stated in the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD 20.32) for TAVR. 
EXPERIMENTAL/INVESTIGATIONAL
In accordance with Medicare, ​all other uses of TAVR are considered experimental/investigational and, therefore, not covered, with the exception of Coverage with Evidence Development (CED)​​ for the treatment of asymptomatic severe AS.

COVERAGE WITH EVIDENCE DEVELOPMENT
TAVR is eligible for coverage consideration for the treatment of ​asymptomatic AS when ALL of the following conditions are met:
  • The procedure is furnished with a complete aortic valve and implantation system that has received FDA PMA for that system's FDA-approved indication.
  • The individual (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi​disciplinary team of medical professionals with a specialized focus in cardiac care. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal individual-centered care. Heart teams include the following:
    • ​​​At least one cardiac surgeon and one interventional cardiologist experienced in the care and treatment of aortic valve diseases and each with clinical privileges at the hospital where the TAVR will be furnished; and
    • Advanced practice clinicians, nurses, administrators and, as needed, members from other physician specialties and research personnel.
  • ​Suitability for surgical aortic valve replacement (SAVR), TAVR, close surveillance, and palliative care must be evaluated based on individual clinical, anatomical, and procedural characteristics, and lifetime management considerations that account for individual life expectancy. These evaluations must be documented and made available to other heart team members, the individual, and other clinicians involved in the individual's care as appropriate, prior to the day of the procedure. Evaluations must include:
    • ​​An initial evaluation by the heart team, which could be asynchronous using medical records to identify individual suitability for TAVR or other treatments, and includes input from both cardiac surgery and interventional cardiology; and
    • An in-person evaluation by a heart team TAVR operator. This cannot be satisfied through a virtual encounter.​
  • ​​The professional and facility providers meet ALL the requirements as stated in the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD 20.32) for TAVR. ​
Claims for TAVR for individuals enrolled in a CED clinical trial should be submitted to the Medicare Advantage plan.

For a clinical trial involving a Category A Investigational Device Exemption (IDE), professional providers are responsible for checking the CMS coverage website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage prior to billing for the routine costs of a clinical trial involving a Category A IDE device. If Original Medicare determined that the device did, in fact, meet the requirements of coverage, and the clinical trial is approved, the Medicare Advantage plan will be responsible for payment of the routine costs associated with the Category A IDE study. The Category A IDE device remains not covered.

For a clinical trial involving a Category B IDE, professional providers are responsible for checking the CMS coverage website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage, prior to billing for the routine costs of a clinical trial and the Category B IDE device. If Original Medicare determined that the device did, in fact, meet the requirements of coverage, and the clinical trial is approved, the Medicare Advantage plan will be responsible for payment of the routine costs associated with a qualifying clinical trial and the category B IDE device.

​TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) FOR MITRAL VALVE REGURGITATION

EXPERIMENTAL/INVESTIGATIONAL
In accordance with Medicare, transcatheter edge-to-edge repair (TEER) for mitral regurgitation (MR) is considered experimental/investigational and, therefore, not covered, with the exception of CED.

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)
FDA-Approved Indications

TEER for MR is eligible for coverage consideration for the treatment of symptomatic moderate-to-severe or severe functional MR in an individual who remains symptomatic despite stable doses of maximally tolerated guideline-directed medical therapy (GDMT) plus cardiac resynchronization therapy, if appropriate, OR for the treatment of significant symptomatic degenerative MR when ALL of the following conditions are met:
  • The procedure is furnished with a mitral valve TEER system that has received FDA PMA for that system's FDA-approved indication.
  • The individual, preoperatively and postoperatively, is under the care of a Heart Team.​​
  • The individual's suitability for surgical mitral valve repair, TEER, or palliative therapy should be evaluated, documented, and made available to other Heart Team members. Additionally, for individuals with functional MR, the Heart Team heart failure cardiologist should document that symptoms persist despite maximally tolerated GDMT and cardiac resynchronization therapy, if appropriate, as described below:
    • ​For individuals with functional MR: the Heart Team interventional cardiologist and Heart Team heart failure cardiologist independently evaluate the individual using information in the medical record and a face-to-face examination. The Heart Team heart failure cardiologist may meet this requirement through a review of the individual's records and images if the individual has an established relationship with a cardiologist experienced in treating advanced heart failure.
    • For individuals with degenerative MR: the Heart Team interventional cardiologist and Heart Team cardiac surgeon should independently evaluate the individual using information in the medical record and a face-to-face examination.​​​​​
  • The Heart Team's interventional cardiologist or cardiac surgeon should perform the mitral valve TEER and the Heart Team's interventional echocardiographer should perform transesophageal echocardiography during the procedure. The interventional echocardiographer may not also furnish anesth​esiology during the same procedure. The interventional cardiologist and cardiac surgeon may jointly participate in the intraoperative technical aspects of TEER as appropriate. All physicians who participate in the procedure should have device-specific training as required by the manufacturer.​​
  • The professional and facility providers meet ALL the requirements as stated in the CMS National Coverage Determination (NCD) TEER for mitral valve regurgitation (NCD 20.33).
Claims for TMVR for individuals enrolled in a CED clinical trial should be submitted to the Medicare Advantage plan.

Not Expressly Listed as FDA-Approved Indications

TEER for mitral valve regurgitation is eligib​​​le for coverage consideration for uses that are not expressly listed as an FDA-approved indication when performed within an FDA-approved clinical study that fulfills ALL the requirements as stated in the CMS (NCD 20.33) for TEER for mitral valve regurgitation. Within the clinical study, the Heart Team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intraoperative technical aspects of TEER.

For a clinical trial involving a Category A IDE, professional providers are responsible for checking the CMS coverage website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage prior to billing for the routine costs of a clinical trial involving a Category A IDE device. If Original Medicare determined that the device did, in fact, meet the requirements of coverage, and the clinical trial is approved, the Medicare Advantage plan will be responsible for payment of the routine costs associated with the Category A IDE study. The Category A IDE device remains not covered.

For a clinical trial involving a Category B IDE, professional providers are responsible for checking the CMS Coverage Website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage prior to billing for the routine costs of a clinical trial and the Category B IDE device. If Original Medicare determined that the device did, in fact, meet the requirements of coverage, and the clinical trial is approved, the Medicare Advantage plan will be responsible for payment of the routine costs associated with a qualifying clinical trial and the category B IDE device.

TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR)


EXPERIMENTAL/INVESTIGATIONAL

In accordance with Medicare, transcatheter tricuspid valve replacement (TTVR) for the treatment of symptomatic tricuspid regurgitation (TR) is considered experimental/investigational and, therefore, not covered, with the exception of CED.

 

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)

TTVR is eligible for coverage consideration for the treatment of symptomatic TR when ALL of the following conditions are met:

  • The procedure is furnished according to an FDA market-authorized indication
  • The individual has symptomatic TR despite optimal medical therapy
  • TTVR is considered appropriate by a Heart Team
  • The individual, preoperatively and postoperatively, is under the care of the Heart Team, which includes a cardiac surgeon, interventional cardiologist, cardiologist (with training and experience in heart failure management), electrophysiologist, multimodality imaging specialists, and interventional echocardiographer

Claims for TTVR for individuals enrolled in a CED clinical trial should be submitted to the Medicare Advantage plan.

 

For a clinical trial involving a Category A IDE, professional providers are responsible for checking the CMS coverage website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage prior to billing for the routine costs of a clinical trial involving a Category A IDE device. If Original Medicare determined that the device did, in fact, meet the requirements of coverage, and the clinical trial is approved, the Medicare Advantage plan will be responsible for payment of the routine costs associated with the Category A IDE study. The Category A IDE device remains not covered.

For a clinical trial involving a Category B IDE, professional providers are responsible for checking the CMS Coverage Website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage prior to billing for the routine costs of a clinical trial and the Category B IDE device. If Original Medicare determined that the device did, in fact, meet the requirements of coverage, and the clinical trial is approved, the Medicare Advantage plan will be responsible for payment of the routine costs associated with a qualifying clinical trial and the category B IDE device.


TRANSCATHETER EDGE-TO-EDGE REPAIR FOR TRICUSPID VALVE REGURGITATION (T-TEER)


EXPERIMENTAL/INVESTIGATIONAL

In accordance with Medicare, transcatheter edge-to-edge repair of the tricuspid valve (T-TEER) for the treatment of symptomatic tricuspid regurgitation (TR) is considered experimental/investigational and, therefore, not covered, with the exception of CED.

 

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)

T-TEER is eligible for coverage consideration for the treatment of symptomatic TR when ALL of the following conditions are met:

  • The procedure is furnished according to an FDA market-authorized indication
  • The individual has symptomatic TR despite optimal medical therapy
  • T-TEER is considered appropriate by a Heart Team
  • The individual, preoperatively and postoperatively, is under the care of the Heart Team, which includes a cardiac surgeon, interventional cardiologist, cardiologist (with training and experience in heart failure management), and interventional echocardiographer

Claims for T-TEER for individuals enrolled in a CED clinical trial should be submitted to the Medicare Advantage plan.

 

For a clinical trial involving a Category A IDE, professional providers are responsible for checking the CMS coverage website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage prior to billing for the routine costs of a clinical trial involving a Category A IDE device. If Original Medicare determined that the device did, in fact, meet the requirements of coverage, and the clinical trial is approved, the Medicare Advantage plan will be responsible for payment of the routine costs associated with the Category A IDE study. The Category A IDE device remains not covered.

For a clinical trial involving a Category B IDE, professional providers are responsible for checking the CMS coverage website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage prior to billing for the routine costs of a clinical trial and the Category B IDE device. If Original Medicare determined that the device did, in fact, meet the requirements of coverage, and the clinical trial is approved, the Medicare Advantage plan will be responsible for payment of the routine costs associated with a qualifying clinical trial and the category B IDE device.


REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

BILLING REQUIREMENTS

Claims for TAVR, TEER for MR, TTVR, and T-TEER for individuals enrolled in a CED clinical trial should be submitted to the Medicare Advantage plan.​

Providers must report Modifier Q0 with procedure code to represent investigational clinical service provided in a CMS-approved clinical research study.

Guidelines

This policy is consistent with Medicare’s coverag​e determination. The Company’s payment methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, transcatheter aortic valve replacement (TAVR), transcatheter edge-to-edge repair (TEER) for mitral valve regurgitation​ (MR), transcatheter tricuspid valve replacement (TTVR), and transcatheter edge-to-edge repaid for tricuspid valve regurgitation (T-TEER) are covered under the medical benefits of the Company’s Medicare Advantage products when the criteria listed in this medical policy are​ ​met.

However, services that are identified in this policy as experimentMisspelled Wordal/investigational are not eligible for coverage or reimbursement by the Company.

Benefits and coverage for routine costs associated with qualifying clinical trials for individuals enrolled in Medicare Advantage are administered by Original Medicare.

After Original Medicare has paid its share of the cost for these services, the Company will also pay for part of the costs.

COVERAGE WITH EVIDENCE DEVELOPMENT (CED)

A list of approved CEDs for TAVR, TEER for MR, TTVR, ​and T-TEER are listed and maintained on the CMS website at:
https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/

INVESTIGATIONAL DEVICE EXEMPTION (IDE)

A list of IDE studies meeting CMS’ standards for coverage are listed and maintained on the CMS Coverage website at: https://www.cms.gov/Medicare/Coverage/IDE/Approved-IDE-Studies.html.

Description

TRANSCATHETER AORTIC VALVE REPLACEMENT

Surgical aortic valve replacement (AVR) has been the gold standard for treatment of adults with severe symptomatic aortic stenosis (i.e., narrowing of the aortic valve opening). Until recently, surgical AVR has been the only effective treatment. The most common cause of aortic stenosis in adults is calcification of the valve. This calcification progresses from the base of the cusps to the leaflets, and eventually causes a reduction in both leaflet motion and the effective valve area. This calcific disease is similar to atherosclerosis. Rheumatic aortic stenosis disease, related to valvular infection, is less common. In young adults, congenital valve malformations are the more common cause for aortic stenosis.

Technologic advancements have allowed for the delivery of heart valves via catheter as an alternative to open surgical valve replacement. Transcatheter aortic valve replacement (TAVR) treats the stenotic heart valve by displacing and functionally replacing the native aortic valve with a bioprosthetic valve delivered on a catheter via a percutaneous transarterial approach through a peripheral artery (e.g., the femoral artery), a transaortic approach through a limited sternotomy, or a transapical approach through a limited lower thoracotomy. Currently, two transcatheter aortic valves have US Food and Drug Administration (FDA) approval for the treatment of aortic stenosis: the Edwards SAPIEN™ Transcatheter Heart Valve System balloon-expandable valve and the self-expanding Medtronic CoreValve™ Transcatheter Aortic Valve Replacement System (Medtronic Inc. Minneapolis, MN).

On November 2, 2011, the FDA approved the first TAVR device, the Edwards SAPIEN™Transcatheter Heart Valve (THV) system, for marketing in the United States based on the pivotal PARTNER (Placement of AoRtic TraNscathetER Valves) study, which incorporated two parallel prospective, unblinded, randomized, active-treatment controlled, multicenter pivotal trials evaluating the safety and effectiveness of TAVR, via transfemoral or transapical (Cohort A only) delivery, in a stratified population of high-risk (Cohort A) or inoperable (Cohort B) individuals. The Edwards SAPIEN THV was approved for transfemoral delivery in individuals with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open AVR and in whom existing comorbidities would not preclude the expected benefit from correction of the aortic stenosis. The FDA approval includes a statement recommending specific training and experience for professional providers to use the device, as well as continued clinical study and data submission to the Society of Thoracic Surgeons (STS), American College of Cardiology (ACC), and the Transcatheter Valve Therapy (TVT) Registry.

TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) FOR MITRAL VALVE REGURGITATION

Mitral regurgitation (MR) is the second most common valvular heart disease, which can result from a heterogeneous set of disease processes that may affect one or more parts of the mitral valve (MV) complex. MR is a common valvular heart disease that can result from either a primary structural abnormality of the MV complex or a dilated left ventricle due to ischemic or dilated cardiomyopathy, which leads to secondary dilation of an anatomically normal MV.

MR is classified into degenerative and functional MV disease. In degenerative MV regurgitation, disease results from primary structural abnormality of the MV complex. Common causes of degenerative mitral regurgitation (DMR) include MV prolapse syndrome with subsequent myxomatous degeneration, rheumatic heart disease, coronary artery disease, infective endocarditis, and collagen vascular disease. In the functional MR disease, the primary abnormality is dilated ventricle due to ischemic or dilated cardiomyopathy, which leads to secondary dilation of an anatomically normal MV. The severity of MR is classified into mild, moderate, and severe disease on the basis of echocardiographic and/or angiographic findings (1+, 2+ and 3–4+ angiographic grade, respectively).

In individuals with multiple comorbidities, surgical therapy may be underutilized. To address the unmet need for less-invasive MV repair, transcatheter approaches have been presented as a potential alternative to surgical therapy for MR, particularly among individuals who face prohibitively high surgical risks due to their age and comorbidities.

The MitraClip® Delivery System (Abbott Vascular, Menlo Park, CA) consists of implant catheters and the MitraClip device. The device, which is typically percutaneously deployed, is a permanent implant that attaches to the MV leaflets as a treatment for reducing MR with the intended outcomes t​o improve recovery of the heart from overwork, improve function, and potentially halt the progression of heart failure. The procedure is performed under general anesthesia via echocardiographic and fluoroscopic guidance. The heart beats normally during the procedure, and heart-lung bypass support is generally not required. The MitralClip Delivery System received FDA approval through the premarket approval process on October 14, 2013. The device received approval for treatment of significant symptomatic MR (≥3+) due to primary abnormality of the mitral apparatus (DMR) in individuals who have been determined to be at prohibitive risk for MV surgery by a heart team.

The evidence for the use of MitraClip in individuals with severe symptomatic DMR who are considered at prohibitive risk for open surgery includes single-arm cohort studies. No randomized controlled trials (RCTs) have been published evaluating MitraClip in prohibitive surgical risk populations. The reported results from the Endovascular Valve Edge-to-Edge Repair Study (EVEREST) II high-risk registry (HRR) and Real World Expanded Multicenter Study of the MitraClip® System (REALISM) registry subset of prohibitive-risk DMR individuals served as a basis for the FDA premarket approval. The EVEREST II studies included individuals from the EVEREST I feasibility study, EVEREST II RCT, the EVEREST II single arm HRR, and the REALISM Continued Access Protocol (CAP) registry that included high-risk and non–high-risk enrollment. From 2003 to 2012, 544 individuals with ≥3+ DMR were prospectively enrolled in EVEREST I, EVEREST II RCT, EVEREST II HRR registry and the REALISM CAP registry. Of these 544 individuals, 141 were chosen. The charts for these 141 individuals were retrospectively reviewed by a multidisciplinary team that included two experienced MV surgeons and one experienced MV cardiologist for what the authors defined as prohibitive risk. The team also included echocardiographers to assess MR severity. From this group of 141 individuals, 127 met the definition of prohibitive risk and had at least 1 year follow-up.

This cohort included 25 individuals from EVEREST II HRR, 98 from the REALISM CAP registry, and four other individuals. The individuals had a mean age of 82 years, 87% New York Heart Association (NYHA) functional class III/IV, with STS score of 13.2% ± 7.3%. Comorbidities included congestive heart failure (125/127), coronary artery disease (95/125), cerebrovascular disease history (24/127), chronic obstructive pulmonary disease (40/127), and diabetes (38/127). Adverse events were adjudicated by an independent Clinical Events Committee.

In individuals who received the device, either one (44.1%) or two (51.2%) clips were implanted. Six individuals did not receive a device, with four of these failures due to technical reasons and the remaining two having complications during the procedure that included tamponade and hemodynamic instability. Despite being determined to be at prohibitive risk for surgery, three individuals did have open surgery, with two of the three alive at 1 year. Adverse events at 1 year included 30 deaths (23.6%) as well as stroke (2.4%), renal failure (3.9%), bleeding complication (15.7%), vascular complication (7.1%), and gastrointestinal complication requiring surgery (2.4%). Most surviving individuals (82.9%) at 1 year had MR ≤2+ and were in NYHA functional class I or II. One-year survival appeared to be better for individuals who had 1+ or 2+ MR at discharge versus those who had 3+ or 4+. Short Form-36 health survey scores improved and the authors reported that hospitalizations were reduced in individuals whose MR was reduced.

The authors stated that the data were limited in that it was not completely from a randomized trial, due to not having a control arm to randomize to (as medical therapy lacks a treatment role in DMR, and surgical options are not standard in prohibitive surgical risk individuals). Because the cohort was retrospectively identified, all analyses were post-hoc.

The authors concluded that MitraClip therapy is safe in individuals with severe, primary DMR for whom a Heart Team has determined that MV surgery is associated with a prohibitive risk/benefit ratio. Transcatheter reduction of DMR in these individuals provides significant benefits including improvements in symptoms and functional status, a decrease in hospitalizations, and favorable left ventricular remodeling at 1 year.

TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR)


​Tricuspid valve repair/replacement surgery is associated with high mortality rates, particularly among those with comorbidities. A transcatheter approach is a minimally invasive technique that may be a potential treatment option for those with tricuspid regurgitation (TR).​


Buğan et al. (2022) performed a systematic review and meta-analysis to assess the feasibility of orthotopic TTVR devices, echocardiographic, functional improvements, and mortality rates following replacement in individuals with significant tricuspid valve regurgitation. The efficacy and safety outcomes for TTVR for significant tricuspid valve regurgitation were the improvements in NYHA functional class, 6-minute walking distance, all-cause death, and periprocedural and long-term complications. In addition, a random-effect meta-analysis was performed comparing outcomes before and after TTVR. Nine studies with 321 individuals were included in this study. The mean age was 75.8 years, and the mean European System for Cardiac Operative Risk Evaluation II score was 8.2% (95% confidence interval [CI]; 6.1–10.3). Severe, massive, and torrential tricuspid valve regurgitation was diagnosed in 95% of individuals (95% CI, 89%–98%), and 83% (95% CI, 73%–90%) of individuals were in NYHA functional class III or IV.  At a weighted mean follow-up of 122 days, NYHA functional class (risk ratio, 0.20; 95% CI, 0.11–0.35; P<0.001) and 6-minute walking distance (mean difference, 91.1 m; 95% CI, 37.3–144.9 m; P<0.001) improved. The prevalence of severe or greater tricuspid valve regurgitation was reduced after TTVR (baseline risk ratio, 0.19; 95% CI, 0.10–0.36; P<0.001). In total, 28 individuals in the trial (10%; 95% CI, 6%–17%) died. 


Pooled analyses demonstrated nonsignificant differences in hospital and 30-day mortality and greater than 30-day mortality than predicted operative mortality (risk ratio, 1.03; 95% CI, 0.41–2.59; P=0.95, risk ratio, 1.39; 95% CI, 0.69–2.81; P=0.35, respectively). The authors concluded that TTVR could be an emerging treatment option for people with severe TR who are not eligible for transcatheter repair or surgical replacement because of high surgical risk. Limitations include a potential for bias as the analysis only included single-arm interventional studies case series, and no RCTs. Moderate heterogeneity was found in the consistency of results. In addition, there are no specific guideline recommendations for inclusion criteria for TTVR; therefore, this meta-analysis is limited by the lack of uniformity in the definition of procedural success. Further research including RCTs with a consistent definition of procedural success are needed to determine the effectiveness of TTVR in individuals with significant tricuspid valve regurgitation.  


The Edwards EVOQUE Tricuspid Valve Replacement System received FDA approval through the premarket approval process on February 1, 2024. This device is indicated for the improvement of health status in individuals with symptomatic severe TR despite optimal medical therapy, for whom tricuspid valve replacement is deemed appropriate by a heart team. 


The TRISCEND (Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device) study, which was a single-arm prospective study, underwent an interim analysis of 176 individuals who received the Edwards EVOQUE Tricuspid Valve Replacement system (discussed by Kodali et al., 2023). The inclusion criteria were individuals with greater than or equal to moderate TR despite receiving medical therapy and who were deemed appropriate to receive a TTVR by a Heart Team. The results of the study observed significant improvements in clinical (TR reduction, increased stroke volume and cardiac output), functional (NYHA Class improvement), and quality-of-life outcomes (Kansas City Cardiomyopathy Questionnaire [KCCQ]). The improvements were sustained for 1 year after replacement.


The key limitation of the study is the lack of comparison to a control, which is being completed in the TRISCEND II Pivotal Trial. Investigators also describe the need for a larger, more generalizable cohort as their participant population was highly selected. The investigators also report that there was incomplete echocardiographic data, highlighting the challenges of tricuspid valve imaging. Lastly, this is an interim analysis and the not all participants had reached 1-year follow-up and were not included.

TRISCEND II (NCT04482062) is an ongoing, open label, prospective, multicenter, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE system with optimal medical therapy (OMT) compared to OMT alone in the treatment of individuals with at least severe TR. Subjects will be followed at discharge, 30 days, 3 months, 6 months, and annually through 5 years. An interim analysis was performed to assess safety outcomes using EVOQUE, which was included in the FDA approval. Many of the outstanding questions as result of the limitations from TRISCEND I are being investigated in TRISCEND II Pivotal Trial.


Hahn et al. (2024) published the 1-year results of the open-label TRISCEND II trial. A total of 400 individuals were randomly assigned (267 treatment; 133 control). The primary outcome was a hierarchical composite of death from any cause, implantation of a right ventricular assist device or heart transplantation, post index tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one NYHA functional class, and an improvement of at least 30 minutes on the 6-minute walk distance. This outcome was analyzed by a win ratio. At 1 year, the win ratio (WR) statistically favored the treatment group (WR, 2.02; P<0.001). The authors concluded that the statistical significance was primarily driven by improvements in symptoms and quality of life, although annualized rate of hospitalization, severe bleeding, and new pacemakers were all greater in the treatment group.


In 2025, Arnold et al. analyzed the quality of life metrics of the TRISCEND II beyond that of Hahn et al. KCCQ-OS scores as a whole, and each individual domain, were significantly greater among individuals receiving the treatment compared to controls at 30 days, 6 months, and 1 year. A similar result is reiterated several times with differing statistical tests throughout the analysis. An exploratory analysis of various subgroups revealed that baseline TR severity, 6-minute walk distance, and right ventricular fractional area change had significant interaction with the treatment.


TRANSCATHETER EDGE-TO-EDGE REPAIR FOR TRICUSPID VALVE REGURGITATION (T-TEER)

 

Tricuspid valve repair/replacement surgery is associated with high mortality rates, particularly among those with comorbidities. A transcatheter approach is a minimally invasive technique that may be a potential treatment option for those with TR. T-TEER could be proposed as an effective treatment for high surgical risk individuals who are nonresponsive to optimal medical therapy.


The TriClip G4 System received FDA approval through the premarket approval process on April 1, 2024. This device is indicated for improving quality of life and functional status in individuals with symptomatic severe TR 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 TR severity to moderate or less, as determined by a multidisciplinary heart team. 



In 2023, Sorajja et al. reported results of the TRILUMINATE pivotal trial. TRILUMINATE was a multicenter prospective randomized trial of percutaneous tricuspid transcatheter edge-to-edge repair for severe TR that was conducted in the United States, Canada, and across various European countries using the TriClip device. Individuals with symptomatic severe regurgitation were randomly assigned in a 1:1 ratio to receive either T-TEER or medical therapy (control). The primary endpoint was a hierarchical composite that included death from any cause or tricuspid-valve surgery; hospitalization for heart failure; and an improvement in quality of life as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), with an improvement defined as an increase of at least 15 points in the KCCQ score (range, 0–100, with higher scores indicating better quality of life) at the 1-year follow-up. The severity of TR and safety were also assessed. 


A total of 350 individuals were enrolled; 175 were assigned to each group. The mean age was 78 years, and 54.9% were women. The results for the primary end point favored the T-TEER group (win ratio, 1.48; 95% CI, 1.06–2.13; P=0.02). The incidence of death or tricuspid-valve surgery and the rate of hospitalization for heart failure did not appear to differ between the groups. The KCCQ quality-of-life score changed by a mean (± standard deviation [SD]) of 12.3±1.8 points in the T-TEER group, as compared with 0.6±1.8 points in the control group (P<0.001). At 30 days, 87.0% of the individuals in the T-TEER group and 4.8% of those in the control group had TR of no greater than moderate severity (P<0.001). T-TEER was found to be safe; 98.3% of the individuals who underwent the procedure were free from major adverse events at 30 days. The authors concluded that tricuspid T-TEER was safe for individuals with severe TR, reduced the severity of TR, and was associated with an improvement in quality of life; however, the components of the primary end point showed no significant differences in all-cause mortality, need for tricuspid valve surgery, or hospitalizations for heart failure between the device and control groups. The end point was driven entirely by change in KCCQ score between the two groups. 


In 2025, Kar et al. reported the 2-year outcomes of the TRILUMINATE trial. The prespecified 2-year outcomes were (1) recurrent heart failure hospitalization and (2) freedom from all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention. Individuals were allowed to switch from the control arm to the intervention arm at 1 year. This crossover severely limits interpretation of the results and introduces selection bias. Nevertheless, annualized recurrent heart failure hospitalization was significantly decreased among those who were randomly assigned to the intervention arm compared to those who were randomly assigned to the control arm at 2 years. Additionally, those who were randomly assigned to the intervention arm had greater freedom from the composite all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention compared to those who were randomly assigned to the control arm at 2 years. However, this result is driven primarily through tricuspid valve intervention (i.e., crossover), while all-cause mortality and tricuspid valve surgery were similar between the groups at 2 years.


Also in 2025, Donal et al. published an investigator-initiated randomized trial of TriClip in Belgium and France. The trial enrolled 300 individuals (152 randomly assigned to T-TEER and OMT, 148 randomly assigned to OMT), with very similar inclusion/exclusion criteria as the TRILUMINATE trial. The primary outcome was a composite endpoint comprising NYHA class, patient global assessment (PGA), and occurrence of major cardiovascular events (i.e., cardiovascular heart failure or death) at 1 year. Individuals were considered improved, unchanged, or worse. "Improved" required no major cardiovascular events and a favorable change in NYHA and/or PGA improved to less than 4. "Unchanged" required no major cardiovascular events and no change in NYHA and PGA. "Worse" required a major cardiovascular event, a worsened NYHA, or PGA greater than 4. Rates of improvement were statistically significantly greater among the intervention arm compared to optimal medical therapy (74.1% vs. 40.6%, respectively), primarily driven by NYHA and PGA. There were no differences in hospitalizations or cardiovascular death. Overall, the conclusions of this trial confirm the results found in the TRILUMINATE pivotal trial.


von Bardeleben et al. (2023) reported on the 2-year follow-up results and outcomes of the prospective, multicenter, international European and US single-arm TRILUMINATE trial evaluating the safety and performance of the T-TEER using the TriClip implant. A reduction in heart failure hospitalization and general hospitalization was more pronounced at 2 years than reported previously, with 84% and 49%, respectively. TR reduction at 30 days was unchanged up to 2 years in 50% of subjects and improved in 25%. Although TR grade worsened in 25% of subjects, the majority remained at moderate or less. There was favorable remodeling of RV size and function in the setting of sustained reductions in TR, despite more variable dilatation of the tricuspid annulus and right atrium in the disease process. In this setting, all-cause (and cardiovascular) mortality was low at 30 days, 1 year, and 2 years, respectively, with 0%, 7.3%, and 18.7% (15.3%), respectively. Quality-of-life improvements and 6-minute walk-test improvements of 60 meters were sustained over 24 months. Limitations of this study include its unblinded, nonrandomized, and lack of sham device design. Additionally, this arm of the TRILUMINATE trial had a limited number of participants and the investigators indicate that most of the enrolled individuals had preserved left ventricular function, limiting the generalizability of the results, which may vary among different heart failure cohorts. The authors note that further randomized GDMT-controlled trials to establish the application of this new transcatheter repair in clinical practice are warranted and are ongoing. 


In 2024, Nickenig et al. reported the 3-year outcomes of the single-arm TRILUMINATE study. Of the 98 individuals enrolled in the trial, 48 continued in the trial through 3 years. A reduction to m​oderate or less TR was achieved in 79%, NYHA III/IV was observed in 19% (compared to 76% at baseline), and KCCQ score improved from baseline (though decreased from 1 year). All-cause mortality was 27% through 3 years.


Bocchino et al. (2021) performed a meta-analysis to assess the pooled clinical and echocardiographic outcomes of different isolated TTVR strategies for moderate or greater TR in participants who were ineligible for surgery. Fourteen observational studies (n = 771) were included. At a mean follow-up of 212 days, 209 individuals (35%) were in NYHA functional class III or IV compared with 586 participants (84%) at baseline. Six-minute walking distance significantly improved by a mean 50 meters. A total of 147 participants (24%) showed severe or greater TR after isolated transcatheter tricuspid valve repair compared with 616 (96%) at baseline. The included studies are at a high risk of bias due to several factors: small sample size, single-center focus, retrospective design, and/or lack of controls, randomization, and blinding. Further results from prospective RCTs are needed to confirm these findings.

References

Arnold SV, Hahn RT, Thourani VH, et al. Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial. J Am Coll Cardiol. 2025;85(3):206-216.


Bocchino PP, Angelini F, Vairo A, et al. Clinical Outcomes Following Isolated Transcatheter Tricuspid Valve Repair: A Meta-Analysis and Meta-Regression Study. JACC Cardiovasc Interv. 2021;14(20):2285-2295.


Buğan B, Çekirdekçi Eİ, Onar LÇ, Barçın C. Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation: A Systematic Review and Meta-analysis. Anatol J Cardiol. 2022;26(7):505-519.


Centers for Medicare & Medicaid Services (CMS). Coverage with Evidence Development Studies. [CMS Web site]. 06/05/2018. Available at: https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development/index. Accessed September 14, 2026.​

Centers for Medicare & Medicaid Services (CMS). Medicare Coverage Related to Investigational Device Exemption (IDE) Studies. Approved IDE studies. [CMS Web site]. 09/26/2023. Available at: https://www.cms.gov/Medicare/Coverage/IDE/Approved-IDE- Studies.html. Accessed September 14, 2026.


Centers for Medicare & Medicaid Services (CMS). National Coverage Analysis (NCD). Transcatheter Aortic Valve Replacement (TAVR) CAG-00430R2 [CMS Web site]. 09/10/2026. Available at: NCA - Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430R2) - Decision Memo. Accessed September 14, 2026.​


Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER) 20.38. [CMS Web site]. 01/05/2026. Available at: NCD - Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER) (20.38). Accessed September 14, 2026.


Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Transcatheter Tricuspid Valve Replacement (TTVR) 20.37. [CMS Web site]. 01/05/2026. Available at: NCD - Transcatheter Tricuspid Valve Replacement (TTVR) (20.37)​. Accessed September 14, 2026.


Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Transcatheter Aortic Valve Replacement 20.32. [CMS Web site]. 06/21/2019. Available at: NCD - Transcatheter Aortic Valve Replacement (TAVR) (20.32) (cms.gov). Accessed September 14, 2026.


Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Transcatheter Edge-to-Edge Repair for Mitral Valve Regurgitation. 20.33. [CMS Web site]. 07/31/2023. Available at: NCD - Transcatheter Edge-to-Ed​ge Repair (TEER) for Mitral Valve Regurgitation (20.33) (cms.gov). Accessed September 14, 2026.


Clinical Trials.gov. Edwards cardioband tricuspid valve reconstruction early feasibility study. [Clinical Trials.gov Web site]. 12/27/2017. Available at: https://clinicaltrials.gov/ct2/show/NCT03382457. Accessed September 14, 2026.


Donal E, Dreyfus J, Leurent G, et al. Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial. JAMA. 2025;333(2):124-132.


Hahn RT, Makkar R, Thourani VH, et al. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. N Engl J Med. 2025;392(2):115-126.


Kar S, Makkar R, Whisenant B, et al. Two-year outcomes of transcatheter edge-to-edge repair for severe tricuspid regurgitation: the TRILUMINATE pivotal randomized controlled trial. Circulation. 2025;151(23):1630-1638.


Kodali S, Hahn RT, Makkar R, et al. Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study. Eur Heart J. 2023;44(46):4862-4873.


Nickenig G, Lurz P, Sorajja P, et al. Percutaneous Edge-to-Edge Repair for Tricuspid Regurgitation: 3-Year Outcomes From the TRILUMINATE Study. JACC Cardiovasc Interv. 2024;17(18):2113-2122.​


Sorajja P, Whisenant B, Hamid N, et al. Transcatheter Repair for Patients with Tricuspid Regurgitation. N Engl J Med. 2023;388(20):1833-1842.


US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Abbott TriClip G4 System. Premarket Approval. [FDA Web site]. 04/01/2024. Available at: Premarket Approval (PMA)​. Accessed September 14, 2026.


US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Edwards EVOQUE Tricuspid Valve Replacement System. Premarket Approval. [FDA Web site]. 02/01/2024. Available at: Edwards EVOQUE Tricuspid Valve Replacement System – P​230013 | FDA. Accessed September 14, 2026.


US Food and Drug Administration (FDA). Center for Devices and Radiological Health. Edwards SAPIEN™ Transcatheter Heart valve. 510(k) summary. [FDA Web site]. 11/02/2011. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100041a.pdf. Accessed September 14, 2026.

US Food and Drug Administration. Summary of Safety and Effectiveness for the Edwards SAPIEN™ Transcatheter Heart Valve (PMA P11021). [FDA Web site]. 10/1392012. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf11/P 110021B.pdf. Accessed September 14, 2026.​


von Bardeleben RS, Lurz P, Sorajja P, et al. Two-Year Outcomes for Tricuspid Repair With a Transcatheter​ Edge-to-Edge Valve Repair From the Transatlantic TRILUMINATE Trial. Circ Cardiovasc Interv. 2023;16(8):e012888.

Coding

CPT Procedure Code Number(s)
0345T, ​0569T, 0570T, 0646T, 33361, 33362, 33363, 33364, 33365, 33366, 33367, 33368, 33369, 33418, 33419
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
​TRANSCATHETER AORTIC VALVE REPLACEMENT IS MEDICALLY NECESSARY WHEN REPORTED WITH ANY OF THE FOLLOWING DIAGNOSIS CODES:  

I06.0       Rheumatic aortic stenosis
I06.2       Rheumatic aortic stenosis with insufficiency
I35.0       Nonrheumatic aortic (valve) stenosis
I35.2       Nonrheumatic aortic (valve) stenosis with insufficiency
Q23.0     Congenital stenosis of aortic valve



TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IS ELIGIBLE FOR REIMBURSEMENT UNDER MEDICARE'S COVERAGE WITH EVIDENCE DEVELOPMENT (CED) PROGRAM WHEN REPORTED  WITH THE Q0 MODIFER, AND THE FOLLOWING DIAGNOSIS CODE : 

Z00.6      Encounter for examination for normal comparison and control in clinical research program

AND ANY OF THE DIAGNOSIS CODES LISTED BELOW:

I06.0       Rheumatic aortic stenosis
I06.2       Rheumatic aortic stenosis with insufficiency
I35.0       Nonrheumatic aortic (valve) stenosis
I35.2       Nonrheumatic aortic (valve) stenosis with insufficiency
Q23.0     Congenital stenosis of aortic valve

​

TRANSCATHETER EDGE-TO-EDGE REPAIR (TEER) IS ELIGIBLE FOR REIMBURSEMENT UNDER MEDICARE'S COVERAGE WITH EVIDENCE DEVELOPMENT (CED) PROGRAM WHEN REPORTED  WITH THE Q0 MODIFER AND ANY OF THE FOLLOWING DIAGNOSIS CODE:

Z00.6      Encounter for examination for normal comparison and control in clinical research program

AND ANY OF THE DIAGNOSIS CODES LISTED BELOW:

I34.0       Nonrheumatic mitral (valve) insufficiency 
Q23.3     Congenital mitral insufficiency



TRANSCATHETER EDGE-TO-EDGE REPAIR (T-TEER) AND TRANSCATHETER TRICUSPID VALVE REPLACEMENT (TTVR)IS ELIGIBLE FOR REIMBURSEMENT UNDER MEDICARE'S COVERAGE WITH EVIDENCE DEVELOPMENT (CED) PROGRAM WHEN REPORTED  WITH THE Q0 MODIFER AND ANY OF THE FOLLOWING DIAGNOSIS CODE:

Z00.6      Encounter for examination for normal comparison and control in clinical research program

AND ANY OF THE DIAGNOSIS CODES LISTED BELOW:

I07.1     ​  Rheumatic tricuspid insufficiency
I36.1       Nonrheumatic tricuspid (valve) insufficiency ​​
​Q22.8     Other congenital malformations of tricuspid valve​


HCPCS Level II Code Number(s)
N/A
Revenue Code Number(s)
N/A

Modifiers

THE FOLLOWING MODIFIER MUST BE APPENDED TO 0345T, 0569T, 0570T, 0646T, 33361, 33362, 33363, 33364, 33365, 33366, 33367, 33368, 33369, 33418, 33419 IN ORDER TO BE CONSIDERED FOR REIMBURSEMENT​ WHEN SERVICES ARE PROVIDED IN A CED STUDY:​

Q0 Investigational clinical service provided in a clinical research study that is in an approved clinical research study

Coding and Billing Requirements

Claims for TAVR, TEER for MR​, ​TTVR, ​and T-TEER should be submitted to the Medicare Advantage plan.

Policy History

Revisions From MA11.027h:
09/10/2026
​​This version of the policy will be issued on 10/05/2026 with an effective date of 09/10/2026​.

This policy was updated to communicate revised criteria​ for transcatheter aortic valve replacement in accordance with the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) Transcatheter Aortic Valve Replacement (TAVR).

​​The Company's coverage position of TAVR for the treatment of symptomatic aortic stenosis has changed from experimental/investigational with the exception of coverage with evidence development (CED) to medically necessary and for the treatment of asymptomatic aortic stenosis from experimental/investigational to experimental/investigational with the exception of CED.

Revisions From MA11.027g:
04/01/2026​The policy has been reviewed and reissued to communicate the Company’s continuing position on Transcatheter Cardiac Valve Procedures.
07/02/2025​This version of the policy will be issued on 09/22/2025 with a retroactively effective date of 07/02/2025​.

This policy was updated to communicate revised criteria for transcatheter edge-to-edge repair for tricuspid valve regurgitation in accordance with the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER), providing coverage with evidence development (CED).
​
The following CPT codes have been added to this policy as medically necessary:
0569T, 0570T

Revisions From MA11.027f:
03/19/2025​This version of the policy will be issued on 05/19/2025 with a retroactive effective date of 03/19/2025​.

This policy was updated to communicate revised criteria for transcatheter tricuspid valve replacement in accordance with the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) Transcatheter Tricuspid Valve Replacement (TTVR).
​
The following CPT code has been added to this policy as medically necessary:

0646T

The following ICD-10 codes have been added ​to this policy:

​I07.1 Rheumatic tricuspid insufficiency
I36.1 Nonrheumatic tricuspid (valve) insufficiency​

Revisions From MA11.027e:
​04/02/2025

​This policy has been reissued in accordance with the Company's annual review process.​
09/09/2024​This version of the policy will become effective 09/09/2024.

This policy was updated to communicate revised criteria for transcatheter aortic valve replacement (TAVR) and transcatheter edge-to-edge repair (TEER) for ​mitral valve regurgitation in accordance with the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) Transcatheter Aortic Valve Replacement 20.32 and NCD Transcatheter Edge-to-Edge Repair for Mitral Valve Regurgitation. 20.33.​

Revisions From​ MA11.027d:
​01/01/2024

​Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.​
09/20/2023This policy has been reissued in accordance with the Company's annual review process.
10/01/2022Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.​

This policy has been identified for an ICD-10 code update, effective 10/01/2022.

The following ICD-10 code has been deleted from this policy 
  • ​I34.8 Other nonrheumatic mitral valve​ disorders

The following ICD-10 codes have been added to this policy: 
  • I34.81 Nonrheumatic mitral (valve) annulus calcification
  • I34.89 Other nonrheumatic mitral valve disorders​

Revisions From MA11.027c:
12/18/2019The policy has been reviewed and reissued to communicate the Company’s continuing position on Transcatheter Aortic-Valve Replacement (TAVR) and Transcatheter Mitral Valve Repair (TMVR).
05/09/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on Transcatheter Aortic-Valve Replacement (TAVR) and Transcatheter Mitral Valve Repair (TMVR).
08/30/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on Transcatheter Aortic-Valve Replacement (TAVR) and Transcatheter Mitral Valve Repair (TMVR).
12/23/2016This version of the policy will become effective 12/23/2016.

Policy updated to communicate continued position on Transcatheter Aortic-Valve Replacement (TAVR) and Transcatheter Mitral Valve Repair (TMVR).

Policy criteria revised with removal of inoperable criteria for TAVR in accordance with Medicare

The following CPT code has been added to this policy: 33366 (medically necessary)

The following ICD-10 CM codes have been removed from this policy:

I05.0 Rheumatic mitral stenosis
I05.2 Rheumatic mitral stenosis with insufficiency
I34.2 Nonrheumatic mitral (valve) stenosis

The following ICD-10 CM code has been added to this policy: (medically necessary)

I34.8 Other nonrheumatic mitral valve disorders

The following Modifier has been removed from this policy:
63 Two Surgeons

Revisions From MA11.027b:
02/03/2016Policy updated to communicate continued position on Transcatheter Aortic-Valve Replacement (TAVR) and Transcatheter Mitral Valve Repair (TMVR).
12/23/2015This version of the policy will become effective 02/03/2016.

Policy updated to communicate continued position on Transcatheter Aortic-Valve Replacement (TAVR) and Transcatheter Mitral Valve Repair (TMVR).

Revisions From MA11.027a:
08/12/2015This is a coding update.
This policy has been identified for the CPT code update, effective 07/01/2015.
The following CPT code have been added to this policy: 33418, 33419.

Revisions From MA11.027:
01/01/2015This is a new policy.
9/10/2026
10/5/2026
MA11.027
Medical Policy Bulletin
Medicare Advantage
No
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