Press Releases

Senator Roberts Applauds Passage of Major Medical Innovation Legislation

Contains numerous provisions championed by Roberts impacting Kansans

Dec 07 2016

WASHINGTON – U.S. Senator Pat Roberts (R-Kan.), a member of the Senate Committee on Health, Education, Labor and Pensions (HELP), today praised Senate passage of the 21st Century Cures Act, bipartisan legislation to spur medical innovation and improve treatments available to patients. The legislation contains several provisions championed by Roberts.

“The Twenty-First Century Cures Act is a true victory for every patient and our health care system,” said Roberts. “This bipartisan legislation includes countless benefits for Kansans, giving healthcare providers new tools and drugs to heal and give hope to individuals – and reduce the time it takes to get treatments from the research bench directly to patients.”

 Roberts spoke on the Senate floor to highlight many of the provisions he fought for including:

  • Increased funding for the National Institutes of Health (NIH)
  • Increased funding for cancer research, which also benefits the University of Kansas’s Cancer Center
  • Increased transparency for the review and approval of medical devices
  • Increased certainty for the review of combination products at FDA – therapies that do not fit neatly into simply a drug or a device
  • Important reforms to our mental health system – which Roberts supported in committee as part of S. 2680
  • A five-year extension of the Rural Community Hospital Demonstration
  • Durable Medical Equipment Competitive Bidding Payment Extension 

To view his remarks, click here.

Roberts continued, “This legislation sets priorities in research – cancer, precision medicine, regenerative medicine and heartbreaking diseases like Alzheimer’s through the BRAIN initiative – we all know someone affected. It also makes some significant changes in how these therapies are evaluated, hopefully approved, and delivered to patients which will improve the lives of all.” 

The bill passed the Senate by a vote of 94-5 and now heads to the president’s desk for signature. 

Below is the full text of Senator Roberts’ remarks as prepared: 

            Today, we have before us a legislative package that reflects two years of work for the Health, Education, Labor, and Pensions Committee. When we first embarked on this process, the goal was to find ways to spur innovation and reduce the time it takes new therapies and treatments to get from the research bench, to the bedside for patients.

 The Twenty-First Century Cures Act includes some true bipartisan victories for patients and our health care system. 

Throughout my time in Congress, I have been a consistent supporter of funding for the National Institutes of Health, NIH, to fulfill our commitment to prioritizing biomedical research and innovation. NIH research returns priceless benefits to Kansans, giving healthcare providers new tools and drugs to heal and give hope to individuals.

Kansans back home have reaped the benefits of this research investment directly. Back in 2012, the University of Kansas Cancer Center received National Cancer Institute – or NCI – designation.  These centers are major players in research and development for cancer treatment and prevention.

The legislation we will be voting on this week commits an additional $1.8 billion for Vice President Biden’s “cancer moonshot”.  This will not only help KU, as they continue their push toward Comprehensive Cancer Center designation, but all Americans who stand to benefit as we work to win this fight against cancer.

In addition to research funding, the bill includes some provisions I championed to improve and increase transparency in the review and approval process for medical devices.  Specifically, the bill:

  • Encourages the FDA to accept international consensus standards to provide more predictability for innovators;
  • It makes improvements to the Advisory Committee selection process in an effort to provide more transparency;
  • And it provides a technical correction to finally establish a process by which FDA may remove certain products from the Class 1 device reserve list if they think premarket review is no longer necessary to prove reasonable assurances of safety and effectiveness.

The bill also seeks to provide more certainty for the review of combination products – therapies that do not fit neatly into simply a drug or a device - at the FDA, something I joined Senators Isakson and Casey on.

The legislation also includes important reforms to our mental health system, based largely on a bill the HELP Committee passed earlier this year. 

Within this section of the bill, we seek to:

  • Clarify and improve our mental health parity laws;

 

  • Reauthorize the substance abuse and mental health block grants;

 

  • Promote evidence-based practices to ensure we are utilizing our scarce resources on programs that work, and not continuing to fund what doesn’t work;

 

  • And reauthorize the Garrett Lee Smith Memorial Act for suicide prevention and intervention and the National Child Traumatic Stress Initiative.

While there is still much more to be done to address the deficiencies in our current system, this bill is a step in the right direction towards improving access to mental health services and eliminating the stigma of seeking treatment.

Finally, the Twenty-First Century Cures Act includes numerous priorities that my colleagues on the Finance Committee have been working on for several years as well.

One provision I was proud to support in Committee extends the Rural Community Hospital Demonstration program for another five years. 

As our rural hospitals continue to try and make ends meets, this program helps “tweener” hospitals – those that don’t qualify as critical access but wouldn’t survive under the current Medicare payment system – stay afloat. It is a critical program that benefits Kansans in Junction City, Ulysses and Fort Scott by keeping their hospital, and access to care, open.

Another provision I have championed along with Senators Thune and Crapo has been to protect rural access to durable medical equipment under the competitive bidding program.  While we would have liked to see a more permanent solution here, this bill delays applying competitively bid prices in rural areas and requires the Department of Health and Human Services take into account stakeholder input as well as average travel distance, volume of items and services furnished and the number of suppliers in these areas when determining adjustments in bid prices. 

There’s no question that we have many challenges ahead to improve our health care system. And while this package may not be a silver bullet to ensure cures for all that ails us, it sets priorities in research – cancer, precision medicine, regenerative medicine and diseases like Alzheimer’s through the BRAIN initiative. It also makes some significant changes in how these therapies are evaluated, hopefully approved, and delivered to patients which will improve the lives of all.

I urge my colleagues to support this bill.

 

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