Over the past decade, there have been major improvements in treatments for severe, symptomatic aortic and mitral heart valve disease.
Previously, the standard treatment has been highly invasive surgical intervention with long recovery periods, with many patients ineligible for surgery due to advanced age or co-morbidities. Fortunately, advancements in medical technology now provide far-less invasive options known as transcatheter aortic valve replacement and transcatheter mitral valve repair.
Patients who undergo these procedures spend less time in the hospital, experience faster recoveries and often have improved quality of life than patients undergoing traditional open-heart surgery, particularly in the immediate post-procedure period. These treatments have also been literally lifesaving for high-risk (often elderly) patients ineligible for surgery. Not surprisingly, the volume of these less-invasive procedures has grown rapidly and may eclipse open-heart surgery as the first-choice standard of care in the coming years.
In addition to benefiting heart valve disease patients, this evolution in treatment also impacts the ecosystem of hospitals and specialty physicians who make a living treating these conditions. Thoracic surgeons have been saving heart valve disease patients for decades through open-heart surgery; however, interventional cardiologists perform the majority of transcatheter procedures.
In response to these shifting tides, thoracic surgery and cardiology societies have joined forces in recommending Medicare coverage/reimbursement policies for these new technologies. These societies have united to approach the Centers for Medicare and Medicaid Services with recommendations regarding the clinical management pathways for heart valve disease. While those recommendations include laudable guidance regarding professional training and data collection, there is significant risk that some recommendations may restrict patient access.
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The latest example of this is CMS’ coverage determination for treatment of mitral valve disease using transcatheter techniques, for which a proposed decision is due from the agency on Feb. 14. In December, the societies published a joint consensus statement that proposes new annual mitral valve surgical procedural volume requirements for all surgeons and hospitals starting transcatheter programs. This is deeply troubling since there is no established connection between a hospital’s or surgeon’s mitral valve surgical procedure volumes and TMVR outcomes, and no references are included to support this recommendation.
Of note, the Medicare National Coverage Determination on transcatheter mitral valve repair was reopened to evaluate coverage for patients with secondary mitral valve disease. Such patients have advanced heart failure, leading to the need for mitral valve repair.
The standard of care for such patients is guideline-directed medical therapy, not surgery. In addition to these patients frequently being too sick to tolerate surgery, open valve surgery has not demonstrated a clinical benefit in such patients, making medical therapy alone (until the recent introduction of TMVR) these patients’ only option.
The joint consensus statement also recommends separating new and established program requirements, which will create new, unnecessary hurdles for smaller and rural hospitals and exacerbate current access issues and disparities for minority and rural populations.
There is no doubt that thoracic surgeons and cardiovascular interventionalists save thousands of heart valve disease patients with their teamwork, commitment to research and immense training and skill; however, patients are stuck in the midst of a professional sea change in heart valve disease treatment involving the specialist clinician, as well as between major medical centers and smaller, community-based and rural hospitals. We urge CMS and policymakers to adopt a coverage decision that will most benefit the older adults, racial and ethnic minorities, women and rural beneficiaries that the Medicare program is charged to serve.
Susan Peschin, MHS, serves as president and CEO of the Alliance for Aging Research in Washington, D.C. (The alliance receives some financial support from Abbott and Edwards Lifesciences for heart valve disease advocacy work. Learn more about how the alliance is funded here.)
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