CMS Releases Proposed NCD For TMVR

The Centers for Medicare and Medicaid Services (CMS) has released the long-awaited draft national coverage decision (NCD) for transcatheter mitral valve repair (TMVR). Notably, CMS has replaced the TMVR term with transcatheter edge-to-edge repair (TEER) in an effort to "more precisely define the treatment addressed" and avoid confusion with other therapies to repair or replace the mitral valve.

As expected, the proposed NCD includes a revision of covered indications to add secondary/functional mitral regurgitation (FMR). It also incorporates an emphasis on care by a comprehensive heart team and includes facility and operator infrastructure and volume requirements (see table comparing the proposed NCD with the 2019 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document for TMVR).

Of note, CMS does not propose a coverage with evidence development policy requiring participation in a registry, noting that the evidence for an FMR indication is strong enough to meet the threshold of reasonable and necessary coverage. In adding FMR coverage, CMS declined to continue the NCD for degenerative mitral regurgitation (DMR), proposing instead to leave DMR coverage decisions to local contractors given the relatively low incidence of clip intervention needed in this case.

CMS began the process of reconsidering its TMVR NCD  last year as a direct result of advocacy efforts requesting reconsideration from the ACC and others, including the Society of Thoracic Surgeons, the Society for Cardiovascular Angiography, and the American Association for Thoracic Surgery. The College is currently reviewing the proposed NCD in greater detail and working with these societies to provide comments by the July 30 comment deadline. Read the full CMS memo.

New Sites (NCD) New Sites (Expert Consensus)   Existing Sites (NCD) Existing Sites (Expert Consensus)
Operator w/ ≥ 100 career structural heart disease procedures; or ≥ 30 left-sided structural procedures per year Operator with 50 lifetime structural heart procedures      
Operator w/ ≥ 20 career trans-septal interventions including 10 as primary or co-primary operator Operator with 20 trans-septal interventions   Site volume of ≥ 20 transcatheter mitral valve interventions per year or ≥ 40 interventions every two years Site volume of 20 interventions per year or 40 in prior 2 years
Surgeon w/ ≥ 20 mitral valve surgeries in the previous year or ≥ 40 in the 2 years prior to program initiation, 50% of which are mitral valve repairs Surgeon w/ 20 MV surgeries in prior year, or 40 in 2 prior years      
≥ 40 mitral valve surgeries in the previous year prior to program initiation, at least 20 of which are mitral valve repairs Site volume of 40 MV cases prior year or 80 in 2 prior years   Site volume ≥ 20 mitral valve surgeries per year or ≥ 40 every two years Site volume of 20 MV surgeries per year or 40 in prior 2 years
  STS Star rating ≥2 for MVR     STS Star rating ≥2 for MVR
        TVT 30-day all-cause mortality above lowest decile
      Facility w/ ≥ 300 percutaneous coronary interventions (PCI) per year Facility w/ ≥300 PCIs annually
Echocardiographer w/ ≥ 10 trans-septal guidance procedures and ≥ 30 structural heart procedures        

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Angiography, Nuclear Imaging, Mitral Regurgitation

Keywords: ACC Advocacy, Mitral Valve Insufficiency, Mitral Valve, Thoracic Surgery, Percutaneous Coronary Intervention, Medicaid, Centers for Medicare and Medicaid Services (U.S.), Medicare, Cardiac Surgical Procedures, Angiography

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