Millions Await Medicare Ruling on Lifesaving Heart Procedure

By June 15, Medicare is expected to reveal a coverage decision that will significantly impact millions of seniors' access to transcatheter aortic valve replacement (TAVR). This less-invasive procedure offers quicker recovery and lower initial healthcare costs compared to traditional open-heart surgery.

For 14 years, Medicare has enforced Coverage with Evidence Development (CED) for TAVR, restricting coverage to clinical trials and imposing stringent criteria on participating doctors and hospitals. This policy has limited access for millions of beneficiaries, a practice CMS has applied to over 30 treatments across various conditions.

While CMS develops CED policies, professional societies like the Society for Thoracic Surgeons and the American College of Cardiology have notably influenced TAVR's coverage terms. Experts suggest this influence extends beyond clinical expertise, potentially involving financial interests tied to the procedure's ecosystem.

Before TAVR's FDA approval in 2011, open-heart surgery was the only option for aortic stenosis. TAVR, performed via catheter, revolutionized treatment, posing an "existential threat" to some surgical practices. In response, these societies advocated for burdensome requirements, including dual patient appointments, surgeon presence during procedures, mandatory registry enrollment, and hospital procedural volume minimums.

The STS and ACC jointly manage the TVT Registry, charging significant fees for hospital participation, which smaller or rural hospitals may struggle to afford. This creates disparities in TAVR access based on location. Despite data from the registry, which has been collected for over a decade and includes over a million patients, indicating TAVR is routine with narrowed performance gaps across all center volumes, the societies advocate for continued CED.

CMS has no direct data access or enforcement mechanism for its CED research questions, and the last aggregate registry report was published six years ago. This lack of transparency and delayed reporting raises concerns about the evidence development process.

The human cost of delayed TAVR access is substantial, particularly for rural patients. Delayed treatment increases mortality risk by 50% over three years and adds nearly $37,000 in healthcare costs. Onerous CED requirements can add an average of 59 days between diagnosis and treatment.

With over 25 TAVR clinical trials and robust data collected, health policy experts question the continued necessity of CED. Public opinion favors Medicare covering TAVR similarly to open-heart surgery, with 77% agreeing. Policymakers face the question of whether CMS can justify continued evidence development after 14 years, given TAVR's established status as a standard of care.