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Heart Valve Patients Await Medicare Coverage Decision

A pioneering surgery marks a breakthrough for people with a neglected heart valve condition. Will the Medicare system cover it?

People living with what’s known as tricuspid regurgitation are waiting and hoping.

A Less Invasive Surgical Option

People with the underdiagnosed condition have a tricuspid heart valve that doesn’t close completely, allowing blood to leak backward. As a result, patients may develop enlarged organs and breathing difficulty. Fluid can accumulate in their abdomen and legs.

Three years ago, cardiologists in Houston performed a first-in-the-nation valve repair using a new medical device technology called the TriClip™ G4. The EVOQUE Tricuspid Valve Replacement System, another treatment for tricuspid regurgitation, was also approved by the FDA this year. For the 1.6 million patients with tricuspid regurgitation, these technologies could mean actual treatment instead of just palliative care, leading to an improved quality of life.

The Importance of Timely Access

Earlier this year, the FDA reviewed and approved both the TriClip G4 and the EVOQUE Tricuspid Valve Replacement System. Now, the Centers for Medicare and Medicaid Services must make a coverage determination.

Experts worry that delays could keep patients from accessing much-needed treatments.

That could be painful for patients but also for physicians, who historically have had few options to offer their patients with tricuspid regurgitation.

“You’re always optimistic for new technology to come along. And when it finally does, you breathe a huge sigh of relief,” said Stephen Little, MD, one of the physicians who performed the breakthrough surgery in Houston three years ago.

Patient advocates agree.

As with other serious medical conditions, racial disparities exist. White patients with tricuspid regurgitation are more likely to receive a diagnosis and appropriate care.

Improving access, including coverage for treatments like Tri Clip G4 and EVOQUE, could help lessen these disparities for underserved communities.

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