21st Century Cures Act

Floor Speech

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Mrs. BLACKBURN. Mr. Chair, America has been at her best when facing great challenges.

Some of our greatest challenges today are in the area of healthcare.
With over 10,000 known diseases, only 500 have cures.

We need to embrace a national vision of improving lives, and of course, saving money, through a Cures Strategy.

Sepsis is one condition that will benefit from this legislation.

Sepsis is the body's response to an overwhelming infection.

Approximately 250,000 people die from sepsis every year in the U.S. and yet most people have never heard of it.

Sepsis is the #1 most expensive condition treated in U.S. hospitals and in FY11 the aggregate hospital cost for sepsis was more than $20 billion.

This legislation comes too late for Katie McQuestion and Rory Staunton, both who succumbed to sepsis as vibrant, health young people.

But through the work that the CURES legislation will support, we can find ways to identify sepsis earlier and even find ways to prevent sepsis.

The 21st Century Cures legislation includes language that I have authored with my friend from Texas, Rep. Gene Green--the SOFTWARE act.

Getting bureaucracy out of the way and allowing innovation is the goal of SOFTWARE.

SOFTWARE will codify the manner in which FDA approaches health IT--including the wonderful apps that we all use to keep us healthy.

FDA is the agency charged with assuring the safety and efficacy of drugs and medical devices.

But data is not a drug or device and it makes no sense to regulate it as such.

However obvious that is, it hasn't stopped FDA from trying to make medical device law fit health IT.

We need to modernize the FDA authorities to reflect the new technology that is health IT.

SOFTWARE, as included in 21st Century Cures is an important first step in our efforts to modernize the FDA.

It is common sense legislation to provide opportunity for health IT to deliver on the promise of better health for all Americans.

I look forward to working with my colleagues in the Senate to bolster these efforts as SOFTWARE moves through the Senate.

For all the reasons I've outlined, the 21st Century Cures legislation is an important bill. But we must ensure that the new treatments, devices and drugs that will be created as a result of this legislation get to the people that need it the most. And some of the most needy are our nations seniors who get health care through Medicare.

Today, Medicare struggles with the adaption of new technology. Many seniors go years without access to the latest treatment options. We must change that. Congress receives great support from the Medicare Payment Advisory Commission (MedPAC) who offers recommendations and policy support to Congress to improve Medicare.

But as we are on the cusp of changing how health care is delivered, MedPAC could use additional policy support including Commissioners that have real-world expertise in this area, and who understand the changes that need to be made in both Medicare payment and regulatory policies to make that happen. I've been pleased to support such candidates in the past, and will continue to do so in the future.

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