The Centers for Medicare and Medicaid Services (CMS) has issued a proposed decision memo suggesting Medicare coverage for transcatheter tricuspid valve replacement devices. This decision, announced on Thursday, could significantly benefit Edwards Lifesciences, particularly its Evoque heart valve, which is currently seeking a national coverage determination.
The proposed coverage targets patients suffering from severe, symptomatic tricuspid regurgitation, a condition characterized by the tricuspid valve's failure to close properly, leading to blood leakage into the heart's left atrium. CMS plans to implement its Coverage with Evidence Development (CED) program, allowing Medicare coverage contingent upon data collection via clinical trials or registries to ascertain the treatment's effectiveness.
Coverage with Evidence Development
The CMS stipulates that studies must evaluate all-cause mortality and hospitalizations for a minimum of 24 months to thoroughly assess the impact of transcatheter tricuspid valve replacement. This requirement ensures a comprehensive understanding of the procedure's long-term benefits and risks.
Edwards Lifesciences' Evoque Valve
Edwards Lifesciences' Evoque device, an artificial valve constructed from cow tissue and affixed to a self-expanding metal frame, gained FDA approval in February. The device is delivered via a catheter, offering a less invasive alternative to traditional open-heart surgery. Following FDA approval, Edwards promptly requested a national coverage determination for Evoque.
In October, Daveen Chopra, head of Edwards’ transcatheter mitral and tricuspid therapies unit, expressed optimism about receiving a draft national coverage determination for Evoque by the end of the year, with a final decision anticipated in the first quarter. Furthermore, Evoque became eligible for Medicare’s new technology add-on payment (NTAP) in October, enabling select hospital centers to receive payments exceeding standard reimbursement for three years, according to CEO Bernard Zovighian.
Financial Implications and Concerns
Chopra emphasized that the national coverage determination will play a crucial role in determining suitable patients and centers for Evoque, as well as ensuring reimbursement. The NTAP is expected to augment payment amounts for each patient undergoing the procedure. However, during the summer, some physicians and the consumer advocacy group Public Citizen urged CMS to convene a Medicare Evidence Development & Coverage Advisory Committee meeting before making a coverage decision. Their concerns centered on the unblinded nature of Edwards’ pivotal Triscend II study and the 27.4% rate of major adverse events observed in the treatment group after 30 days.
Conversely, other physicians who participated in studies of the device advocated for Evoque's coverage. An interventional cardiologist at Piedmont Heart Institute noted the dramatically positive outcomes observed in their patients.
The CMS is soliciting public comments on the proposed decision memo until January 18, 2025.
