Included in the original law that established Medicare in 1965 was a short but consequential mandate that the program only pay for items and services that are “reasonable and necessary” for the treatment of illness and injury. Over the decades that followed, this requirement was generally viewed as excluding from coverage those medical services and products that were experimental or investigational, or for which there was still uncertainty about the benefits and harms for Medicare patients.
As a result, many new products, though approved by the FDA, would not meet Medicare’s “reasonable and necessary” standard. In some cases, this led to long delays in Medicare patient access to promising, emerging technologies.