How Heart Specialists Benefit From Medicare’s TAVR Restrictions
Medicare is expected to announce a coverage decision by June 15 that could impact access for millions of seniors to a less-invasive procedure for a common type of heart valve disease. The procedure, known as transcatheter aortic valve replacement (TAVR), is preferred by patients because it avoids open-heart surgery, allows for quicker treatment and recovery, and reduces healthcare costs by about $10,000 per patient for Medicare and taxpayers.
For the past 14 years, patient access to TAVR has been restricted under a Coverage with Evidence Development (CED) requirement by the Centers for Medicare & Medicaid Services (CMS). This requirement denies coverage for newer, FDA-approved treatments unless beneficiaries participate in limited clinical trials or studies. The CED policies also impose strict rules on which doctors and hospitals qualify to participate, further limiting access to care for millions of beneficiaries annually.
The Society for Thoracic Surgeons and American College of Cardiology have played a significant role in influencing the specific conditions of coverage and data collection for TAVR. These professional societies have joined forces to advocate for Medicare coverage determinations for new technologies like TAVR, which has raised questions about their motives beyond clinical concerns.
The FDA approval of TAVR in 2011 revolutionized heart valve treatment by providing a less invasive alternative to open-heart surgery. However, this advancement posed a threat to thoracic surgeons who stood to lose a significant portion of their business to interventional cardiologists. In response, the STS and ACC lobbied for Medicare to impose stringent requirements for TAVR coverage, including mandatory face-to-face appointments, enrollment in clinical studies, and annual procedural volume quotas for hospitals.
Research has shown that the volume requirements advocated by professional societies were not true indicators of quality care, and outcomes have improved across all center volume levels as TAVR has become routine. Despite the wealth of data generated from over 25 TAVR clinical trials and more than 1 million patients captured in registries, the CED requirements for TAVR remain in place, raising concerns about the financial interests at play.
A recent poll commissioned by the Alliance for Aging Research found that the majority of participants support Medicare covering TAVR in the same way as open-heart surgery. The prolonged existence of CED requirements for TAVR has raised questions about the adequacy of evidence and the impact on patient access to this standard of care procedure.
In conclusion, the decision by Medicare on June 15 regarding TAVR coverage will have significant implications for millions of seniors with heart valve disease. Health policy experts are calling for a reevaluation of the CED requirements for TAVR to ensure timely access to this life-saving procedure without unnecessary barriers.
