Brian Maher on May 2, 2012 |
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Topics: Cardiac Cath, Cardiovascular, Service Lines, Cardiac Surgery, Vascular, Technology Assessment, Methodologies, Performance Improvement, Medicare, Reimbursement, Finance, Payer and Regulatory Policy, Market Trends, Strategy, Technology Assessment, Planning
Brian Maher
In breaking news this week, the Centers for Medicare and Medicaid Services (CMS) announced its final national coverage decision policy for transcatheter aortic valve replacement (TAVR) as an alternative to open aortic valve replacement (AVR) for clinically indicated patients. While considered a boon to the future of the innovative procedure, CMS has set strict hospital and operator requirements to qualify as a TAVR-performing site and receive reimbursement. Therefore, the final coverage decision will serve to effectively limit TAVR adoption to the most qualified programs and place the procedure in the hands of the most skilled operators – a policy widely accepted by regulators and professional societies alike.
Requiring significant investment in infrastructure
Per CMS’s national coverage decision for TAVR, the requirements listed below must be satisfied in order to qualify for a reimbursement. At a foundational level, the procedure must be furnished in accordance with an FDA-approved indication and with a TAVR system that has received pre-market approval from the FDA. In addition, the following conditions must be satisfied:
- Must be furnished in accordance with an FDA-approved indication
- Independent, face-to-face patient examinations by two cardiac surgeons to determine the patient’s suitability for open aortic valve replacement; the surgeons must also document their rationale for their clinical judgment and communicate it to the heart team caring for the patient
- Pre-operative and post-operative care for the patient by a heart team, defined as a cohesive, multi-disciplinary team of medical professionals who promote collaboration and a dedication toward optimal patient-centered care
- The hospital must have the appropriate infrastructure including, but not limited to:
- On-site heart valve surgery program
- Cardiac cath lab or hybrid operating/cath lab with a fixed angiography system with flat-panel technology
- Non-invasive imaging, including echocardiography, vascular ultrasound, CT, and MRI
- Sufficient space in a sterile environment to accommodate necessary equipment with and without complications
- Post-procedure intensive care unit with clinicians experienced in caring for patients who have received open-heart valve procedures
- Joint participation by the interventional cardiologist(s) and cardiac surgeon(s) during the procedure
- Institutional participation in a prospective, national, audited registry to analyze utilization and outcomes over time
TAVR may also be covered for reimbursement when performed within the confines of an approved clinical study which serves to better evaluate the outcomes, mortality, and complications for patients receiving TAVR out to at least one year before and after the procedure.
Notably, CMS indicates TAVR is not to be covered for for patients in whom existing co-morbidities would preclude the expected benefit from correction of the aortic stenosis.
Requiring specific volume thresholds for (in)experienced programs, operators
In addition to these clinical, personnel, and infrastructure requirements, the national coverage decision stipulates specific volume thresholds and qualifications for hospitals and operators with or without TAVR experience.
For hospitals without prior TAVR experience
- 50 or more AVRs in the previous year prior to TAVR, including at least 10 high-risk patients; AND
- 2 or more physicians with cardiac surgery privileges; AND
- At least 1000 catheterizations per year, including 400 or more PCIs per year
For heart teams without prior TAVR experience
The heart team must include:
- A cardiovascular surgeon with:
- 100 or more career AVRs, including 10 high-risk patients; OR
- 25 or more AVRs in one year; OR
- 50 or more AVRs in 2 years; and which include at least 20 AVRs in the last year prior to TAVR initiation; AND
- An interventional cardiologist with:
- 100 or more career structural heart disease procedures; OR
- 30 or more left-side structural procedures per year, of which 60% should be balloon aortic valvuloplasty (BAV), noting that atrial septal defect and patent foramen ovale closure are not considered left-side procedures; AND
- Additional members of the heart team, such as echocardiographers, imaging specialists, heart failure specialists, cardiac anesthesiologists, intensivists, nurses, and social workers; AND
- Device-specific training as required by the manufacturer
For hospitals with prior TAVR experience
- 20 or more AVRs per year or at least 40 AVRs every 2 years; AND
- 2 or more physicians with cardiac surgery privileges; AND
- At least 1000 catheterizations per year, including 400 or more PCIs per year
For heart teams with prior TAVR experience
The heart team must include:
- A cardiovascular surgeon and an interventional cardiologist whose combined experience maintains the following:
- 20 or more TAVR procedures in the prior year; OR
- 40 or more TAVR procedures in the prior 2 years; AND
- Additional members of the heart team such as echocardiographers, imaging specialists, heart failure specialists, cardiac anesthesiologists, intensivists, nurses, and social workers.
The “how to’s” of building transcatheter valve programs
As we’ve explored in our recent publication, Heart and Vascular Service Line Integration, and as is evident in numerous other facets of CV services, multidisciplinary care is no longer a “nice to have”. The complexity of procedures such as TAVR is requiring specialists who once competed for volumes to now partner through shared decision-making and management of patients for optimal care delivery. This concept is all the more apparent in the final CMS coverage decision which explicitly requires multidisciplinary decision-making and teamwork among different provider types with specialized expertise to provide appropriate, patient-centric care.
However, and despite the clinical promise of TAVR, it remains a loss-leader with unfavorable economics. Early adopters of TAVR report the inability to recoup the costs of the procedure based upon current inpatient reimbursement levels. Our most recent Spring 2012 Transcatheter Valve Technology Briefing explores the financial impact of TAVR, offering a detailed assessment of costs, reimbursement, and overall program profitability.
That being said, significant interest remains among CV programs nationwide regarding the inclusion of TAVR in their growth strategy. How to identify candidate patients, operate aortic and valve centers, and staff and structure TAVR programs are all top-of-mind questions among organizations pursuing TAVR now or potentially in the future. For the 2012-2013 Cardiovascular Roundtable National Meeting Series, we’ll be exploring this topic in great detail, provides lessons learned among early adopters of TAVR, and further elucidating growth strategies and tactics for the development of disease-focused programs. Register today to hold a seat at one of our Fall sessions!
