SILVER SPRING, MD., April 8, 2022 /PRNewswire/ — Ensuring the availability of innovative interventions for people is a shared priority for the Centers for Medicaid & Medicare Services (CMS) and the US Food and Drug Administration (FDA). We recognize the important and related – yet different – roles of our respective agencies and know that decisions by CMS and the FDA have an outsized impact on the US healthcare system, as well as implications for the rest of the world.
Underpinning the work of both our agencies is an unwavering commitment to using reliable data to ensure that effective treatments are available to patients. The FDA’s decision to approve a new medical product is based on a careful evaluation of available data and a determination that the medical product is safe and effective for its intended use. In some cases, the FDA has the authority to require additional studies after approval to provide additional information regarding the expected clinical benefit for the medical product.
CMS may conduct its own independent review to determine whether an item or service should be covered nationwide by Medicare, including considering whether it is reasonable and necessary for use in the Medicare population.
The work of our two agencies is essential to ensure that medical products are available to people across the country.
We recognize the impact of these decisions on people with serious and life-threatening illnesses and their loved ones. We share a common goal of wanting to advance the development and availability of innovative medical products. Our agencies remain committed to using our distinct set of authorities to ensure the continued availability of medical products that meet our respective standards to care for the people we serve.
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Media Contact: FDA Office of Media Affairs, 301-796-4540
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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.
SOURCE US Food and Drug Administration