On May 1 the Center for Medicare and Medicaid Services (CMS) announced approval of a National Coverage Determination (NCD) of transcatheter aortic valve replacement (TAVR). The announcement follows an analysis based on an NCD request from the American College of Cardiology (ACC) and The Society of Thoracic Surgeons (STS) in late 2011.

The NCD covers TAVR under Coverage with Evidence Development (CED) when performed with a Food and Drug Administration (FDA)-approved device consistent with labeled indications and any other FDA requirements.  As of May 1, 2012, the only approved TAVR indication is for “transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis.”

TAVR is not covered in patients in whom existing co-morbidities would preclude the expected benefit from correction of the aortic stenosis.

The NCD permits Medicare coverage only in facilities meeting certain requirements.

Requirements for hospitals without previous TAVR experience:

• ≥ 50 total AVRs in the previous year prior to TAVR, including ≥ 10 high-risk patients; and
  
• ≥ 2 physicians with cardiac surgery privileges; and
  
• ≥ 1000 catheterizations per year, including ≥ 400 PCIs per year

Requirements for Heart Teams without previous TAVR experience:

Cardiovascular surgeon with:

• ≥ 100 career AVRs, including 10 high-risk patients; or
  
• ≥ 25 AVRs in one year; or
  
• ≥ 50 AVRs in 2 years; and which include at least 20 AVRs in the last year prior to TAVR initiation

Interventional cardiologist with:

• Professional experience with 100 structural heart disease procedures lifetime; or
  
• 30 left-sided structural procedures per year of which 60% should be balloon aortic valvuoplasty (BAV). Atrial septal defect and patent foramen ovale closure are not considered lift-sided procedures; and

Additional members of the heart team such as echocardiographers, imaging specialists, heart failure specialists, cardiac anesthesiologists, invensivists, nurses, and social workers; and

Device-specific training as required by the manufacturer

Requirements for hospitals with previous TAVR experience:

• ≥ 20 AVRs per year or ≥ 40 AVRs every 2 years; and
  
• ≥ 2 physicians with cardiac surgery privileges; and
  
• ≥ 1000 catheterizations per year, including ≥ 400 PCIs per year

Requirements for heart teams with previous TAVR experience:

A cardiovascular surgeon and an interventional cardiologist whose combined experience maintains the following:

• ≥ 20 TAVR procedures in the prior year, or;
  
• ≥ 40 TAVR procedures in the prior 2 years; and

Additional members of the heart team such as echocardiographers, imaging specialists, heart failure specialists, cardiac anesthesiologists, invensivists, nurses, and social workers

Interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intraoperative technical aspects of TAVR.

To satisfy CED, the NCD also requires all patients to be included in a prospective, national, audited registry that meets certain criteria. The ACC/STS TVT Registry complies with these criteria.

Medicare coverage will be available for non-FDA-approved indications when performed in a CMS-approved clinical study.

ACC Analysis

The only bar that needs to be met for coverage is FDA-approved indications, not the PARTNER Trial inclusion/exclusion standards that were much more proscriptive.  For the current indications, the service is covered if the heart team is (1) implanting a Sapien valve (2) transfemorally (3) in the native valve of an otherwise inoperable patient (4) whose comorbidities do not preclude benefit.  If it is the documented consensus of the heart team that comorbidities do not preclude benefit, the procedure should be covered.  Conversely, TAVR is not covered in patients in whom existing co-morbidities would preclude the expected benefit from correction of the aortic stenosis.

The Centers for Medicare and Medicaid Services (CMS) deferred to the four-society consensus document on institutional and operator requirements. ACC participated in the process, but suggested in its comments to CMS that those standards are ideal and are currently too restrictive.  We’ll see in the coming months how many facilities are able to meet those standards. 

ACC commented on other areas as well of the draft coverage that were improved in the final determination:

• Requirements for future studies were modified to include non-inferiority studies


• Quality of life indicators must be tracked for 1 year instead of 5 years


• Incidence of stroke can be tracked broadly, rather than dividing ischemic events into major and minor

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