Bill > HR2597

This bill, the Accelerating Innovation in Medicine Act of 2015 (AIM Act of 2015), amends Medicare law to allow manufacturers of medical devices to voluntarily exclude their products from Medicare coverage. This exclusion creates an "AIM list" of devices for which Medicare will not pay, either directly or through bundled payments, meaning no Medicare claims can be submitted for them. Consequently, if a patient chooses to receive a device on this list, they become responsible for paying for both the device and any related services themselves. The Department of Health and Human Services (HHS) is required to maintain and publicly post this AIM list, updating it regularly. Manufacturers must provide written consent to have their devices added to the list, and the inclusion period is initially three years, with potential for renewal if the manufacturer provides data from clinical studies. This provision aims to encourage innovation by allowing manufacturers to introduce new devices and gather outcome data without immediate Medicare coverage hurdles, while also giving patients the option to self-pay for these technologies.