CMS National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR)

On June 27th, 2018 the Centers for Medicare and Medicaid Services (CMS) announced that they are reconsidering the National Coverage Determination (NCD) for transcatheter aortic valve replacement (TAVR).  A NCD is a nationwide policy on whether Medicare will pay for a particular item or service, and under what circumstances.  The current NCD lays out requirements for TAVR procedures used for the treatment of symptomatic aortic stenosis according to an FDA-approved indication.  Reopening the NCD means that CMS is reexamining how TAVR will be covered and reimbursed moving forward.  The new determination could impact access to TAVR—potentially widening or limiting the ability of patients to get TAVR.

Many organizations and experts in the patient, provider, and heart center communities feel that the current NCD restricts patient access and creates inequalities.  Untreated heart valve disease is fatal and heart valve disease is currently undertreated.  The NCD—especially with the procedural volume requirements—creates barriers to a less-invasive, often patient-preferred treatment that has been proven to be a safe and effective option for treating aortic stenosis in inoperable, high-risk, and intermediate-risk patients.  This restricted access creates inequalities since depending on which hospital a patient visits and which doctor they see, patients can have vastly different experiences.  Many in these communities are concerned that any increase in procedural volume requirements could close TAVR facilities and prevent the opening of new ones—and that the subsequent harm outweighs any potential benefit.

On March 26th, 2019, CMS released its proposed updates to its TAVR coverage and requested feedback from the public, including the patient community, by Thursday, April 25th. The Alliance for Aging Research submitted comments to CMS Administrator Seema Verma and the CMS Coverage Analysis Group which were co-signed by a dozen other patient advocacy organizations, including:

• Alliance for Aging Research
• Alliance for Patient Access
• Association of Black Cardiologists
• Caregiver Action Network
• HealthyWomen
• Heart Valve Voice US
• Mended Hearts
• Men’s Health Network
• National Black Nurses Association
• National Hispanic Medical Association
• National Medical Association
• National Minority Quality Forum
• Partnership to Advance Cardiovascular Health
• RetireSafe

This initiative is part of the Heart Valve Disease Policy Task Force.

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