Four U.S. Senators have introduced legislation designed to increase patient access to medical devices by giving them the option of self-paying rather than going through the time-consuming Medicare coverage process.

Sens. Michael Bennet (D-Colo.), Martin Heinrich (D-N.M.), Rob Portman (R-Ohio), and John Thune (R-S.D.) are sponsoring the Accelerating Innovation in Medicine (AIM) Act to enable physicians to provide patients with more timely choices when deciding the best approach for their healthcare. 

“The current medical device process is cumbersome and limits access to innovative devices and procedures for seniors who are willing to pay out of pocket,” said Portman, who co-authored the AIM Act with Heinrich. “Our bill simply allows seniors to take government out of the equation by purchasing these devices themselves rather than through Medicare. Ultimately, it will help to ensure patients and physicians have access to the most innovative medical technologies.”

According to the AIM Act Alliance, a coalition of providers, patient advocacy organizations, and medical device manufacturers, Medicare beneficiaries who are interested in self-paying for a new medical device that is not covered by Medicare currently face significant administrative obstacles. The group argues that the AIM Act will make products approved or cleared by the Food and Drug Administration more easily available to physicians and accessible to patients who wish to self-pay.

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“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,” states the AIM Act Alliance.

In addition, they say the legislation 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,” adds the group.

Further, as a condition for the continued inclusion of a device on the “AIM list” for a subsequent three-year listing period, the manufacturer must provide published or publicly available data on clinical studies completed for the device at the end of the previous three-year listing period.

The group makes the case that “having a window of time in which FDA-approved devices are not submitted for Medicare coverage will facilitate the collection of safety, efficacy, and patient outcome data—equating to privately-funded cost effectiveness data.”  

In the end, they say U.S. taxpayers will reap the benefits of cost savings from the AIM Act. According to the AIM Act Alliance, a recent study estimates that the legislation will save $1.5 billion annually by 2024—with $7.5 billion in cumulative savings over the next 10 years.

The full text of the legislation can be found here.

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