Washington, D.C. – Congresswoman Elise Stefanik (R-NY-21) has cosponsored H.R. 2597, the Accelerating Innovation in Medicine (AIM) Act of 2015. Currently, the newest and most innovative medical technologies are often subject to limited coverage or inadequate reimbursement under Medicare, especially when these products and procedures warrant greater reimbursement than Medicare will offer. If a Medicare beneficiary is interested in self-paying for a new device or procedure that is not covered by Medicare, there can be significant administrative obstacles.

“The AIM act will help North Country seniors by allowing for easier access to new and innovative medical devices,” said Congresswoman Stefanik. “Furthermore, by increasing access to new medical technologies, we can spur innovation and economic growth in our vibrant medical device industry. This bipartisan, commonsense legislation is good for patients and the medical device industry.”

“The AIM Act goes a long way to helping the US remain the world leader in bringing innovative medical devices to market that give both patients and their physicians greater access and choice to new, safe and effective medical technologies,” said Jessica Crawford, President of MedTech. “This legislation will promote high quality job growth in the medical device sector and provide some regulatory clarity to medical device manufacturers which in turn will drive continued investment in the medical device sector.  We thank Representative Stefanik for her continued leadership on issues important to our industry.”

Legislative Specifics:
The AIM Act creates a new category for FDA-approved or cleared medical devices. When an application is filed or a medical device is exempted from FDA approval or clearance, manufacturers may indicate that they do not wish to seek Medicare coverage for their new technology for a period of at least three years. This means that upon FDA approval or clearance, the device will be immediately available as a treatment option for physicians and for Medicare patients who choose to self-pay—with no red tape, paperwork, administrative costs, or risk of penalty.