Bill > S1757

This bill, the Accelerating Innovation in Medicine Act of 2015 (AIM Act), amends Medicare law to allow manufacturers of medical devices to voluntarily opt out of Medicare coverage for their products. This means that if a manufacturer chooses to place a device on the "AIM list," Medicare will not pay for it, nor will any related items or services. Consequently, patients who receive these devices must consent to pay for them themselves, and providers cannot submit claims to Medicare for them. The Department of Health and Human Services (HHS) will maintain and publicly post this AIM list, which will be updated regularly. Manufacturers must provide written consent for their devices to be added, and the inclusion is initially for three years, with potential for renewal if the manufacturer provides data from clinical studies. This provision aims to encourage innovation by allowing new medical technologies to reach patients sooner, even before they are fully evaluated for Medicare coverage, and to provide a pathway for manufacturers to gather more data on their devices.