National Center for Health Research Comment on Medicare Coverage for Transcatheter Tricuspid Valve Replacement

January 18, 2025: National Center for Health Research questioned CMS’ proposed Medicare coverage with evidence development (CED coverage) for TTVR because the device isn’t proven to save lives or reduce hospitalization. In our written public comment, we said that patients’ quality of life is also very important, but it should be evaluated in an unbiased way that does not make a device seem more beneficial than it really is.

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NCHR Public Comment Regarding Device Trial Participation Snapshots

January 13, 2025: In response to FDA’s draft of medical device Snapshots, NCHR urged FDA to add more information about risks and benefits in wording that is easy to understand. The information should also quantify the risks and benefits and explain the implications of the strengths and weaknesses of the evidence. The SnapShots should be brief but should include the information that helps patients and physicians make important decisions about whether the device has benefits that outweigh the risks for patients.

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