Ensuring the availability of innovative interventions for people is a shared priority for both the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA). CMS and FDA decisions have an outsized impact on the U.S. healthcare system, as well as implications for the rest of the world.
Underpinning both agencies’ work is the unwavering commitment to use reliable data to ensure that effective treatments are made available to patients. The FDA’s decision to approve a new medical product is based on a careful evaluation of the available data and a determination that the medical product is safe and effective for its intended use. In some instances, the FDA has the authority to require additional studies after approval to provide additional information regarding the anticipated clinical benefit for the medical product.
CMS can conduct its own independent review to determine whether an item or service should be covered nationally by Medicare, including examining whether it is reasonable and necessary for use in the Medicare population.
The work of both agencies is critical to ensure that medical products are available to people across the country.
The impact these decisions have on people with serious and life-threatening conditions and their loved ones is readily recognized. There is a common goal of wanting to advance the development and availability of innovative medical products. The agencies remain committed to using a distinct set of authorities to ensure the continued availability of medical products that meet the respective standards to care for people.