In a comment letter to the Centers for Medicare and Medicaid Services (CMS), the ACC joined with other CV groups to recommend changes to the Agency's proposed national coverage determination (NCD) for transcatheter edge-to-edge repair (TEER) of the mitral valve. The proposal would provide Medicare coverage for functional mitral regurgitation (FMR) patients based on new trials that expanded FDA indications for the one technology on the market. The proposed NCD would also remove data collection requirements under coverage with evidence development (CED), remove national coverage for degenerative mitral regurgitation (FMR), and include a number of contraindications based on clinical trial exclusion criteria.

The societies strongly encouraged CMS to reinstate CED and national coverage of DMR in the final policy, as they are under the existing policy. CED allows earlier, broader access to therapies to than would otherwise be possible. Clinicians and institutions use the data and reports to develop a real-world evidence base to further optimize patient selection and care pathways. Regulators and sites are able to execute device surveillance. Institutions are able to track performance on key metrics to improve care. Meanwhile, national coverage of all indications would avoid inconsistencies across states or regions and confusion about how to approach patients with mixed disease.

After the comment period closes July 30, CMS will process comments and is scheduled to issue a final policy with any changes by September 28.

Clinical Topics: Valvular Heart Disease, Mitral Regurgitation

Keywords: ACC Advocacy, Mitral Valve Insufficiency, Mitral Valve, Centers for Medicare and Medicaid Services, U.S., Medicaid, Medicare

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