Accelerating Innovation in Medicine (The AIM Act)

Accelerating Innovation in Medicine The AIM Act

Enhancing Access, Research, and Medical Innovation Barriers in the Current Law The newest, 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 are currently significant administrative obstacles:

• Physicians must submit a claim to Medicare, even if the patient wishes to self-pay for the new technology.
• If the patient’s condition and preferred treatment option does not meet Medicare coverage criteria, the physician must provide the patient with an Advanced Beneficiary Notice (ABN) advising of the non-coverage status.
• The patient must then provide written acknowledgement of this notice.
• Even in this case, physicians must still submit a claim to Medicare, noting the non covered status.
• Failure to do so exposes physicians to civil monetary penalties.
• In addition, the CMS coverage determination and coding process is long, complex, and highly dependent on expensive clinical research—with no guarantee that coverage
will be granted.

These barriers have negative consequences for patients and new medical innovation. Bureaucracy, time delays, and uncertainty discourage physicians and patients from considering the newest technologies.

Currently, these obstacles limit manufacturers’ ability to generate robust clinical research data, which is necessary to bring the best innovation to all Medicare beneficiaries.

What the AIM Act Does
The AIM Act creates streamlined access for new, FDA approved or cleared medical devices.
By streamlining access to devices, the AIM Act makes them more easily available to physicians and accessible to patients who wish to self-pay for the new or niche technology
outside the traditional Medicare reimbursement system.

The AIM Act eliminates burdens for patients.
With streamlined access, doctors are able to offer their patients non-covered or self-pay products without administrative burden, penalty, or delay, while continuing to provide covered services to Medicare beneficiaries.

The AIM Act provides certainty to developers
The AIM Act protects innovative medical device developers and investors who are faced with increasing costs and regulatory barriers.

How it Works
The AIM Act creates a new category for FDA-approved or cleared medical devices. When an application is filed or a medical device receives or 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.

The AIM Act makes a simple change to existing law, giving patients and physicians easier access to the most innovative medical technologies approved or cleared by the FDA—and speeding the collection of data that can support a future coverage decision.