Medicare is ending the shortcut that has let manufacturers of FDA-designated Breakthrough Devices collect extra hospital payments without first showing their products work better than what is already available. Through the FY 2020 and FY 2021 hospital payment rules, CMS created an alternative pathway. Devices carrying FDA Breakthrough Device designation were deemed not substantially similar to existing technology and were exempted from the clinical improvement test. CMS closed the alternative pathway that let FDA-designated Breakthrough Devices qualify for extra Medicare hospital payments without demonstrating substantial clinical improvement. This is a hospital payment policy.