August 1, 2023
I’m Dr. Diana Zuckerman, president of the National Center for Health Research and Cancer Prevention and Treatment Fund. Our Center is a public health think tank that focuses on policies and programs that increase the safety and effectiveness of medical products.
We support the goals of the TCET program, but we see an enormous disconnect between the types of evidence that FDA requires for breakthrough devices, especially for 510k devices, and the CED standards that CMS requires for coverage. We hear a lot about flexibility from FDA and industry but not enough about scientific evidence of safety or effectiveness. Innovation should be defined to require that a device is proven to be better, not just newer. We urge CMS to work with industry to make it clear that CMS evidence standards of clinical benefit are very different from the standards required by CDRH. And we urge CMS to urge companies to provide the evidence needed to be worthy of CMS coverage.
Let’s remember that the standards for FDA for devices are not proof of safety or effectiveness, but rather the “reasonable assurance of safety and effectiveness.” And often that “reasonable assurance” is not so reassuring.
I want to reiterate the previous comment that even when the FDA requires clinical data, many types of Medicare beneficiaries are under-represented: older patients, people of color, and women.
I want to thank CMS for this effort to improve access to safe and effective medical products and urge CMS to hold firm to its standard for coverage based on scientific evidence that all medical products are proven to be reasonable and necessary for Medicare patients.