American Association for Cancer Research Interview with Senator Chuck Grassley
AACR Interviews Members of Congress
Tuesday, February 13, 2018
Can you share with our readers, many of whom are cancer survivors, advocates, and researchers, your personal connection to cancer?
My wife Barbara is a breast cancer survivor. Diagnosed 30 years ago, our family was stopped in its tracks when her primary care doctor discovered a lump in each breast during a wellness exam. Just a few years prior to her cancer diagnosis, Barbara had returned to college and the workplace, after taking a hiatus to be at home to raise our five children. She was starting a new chapter in life, and now life was writing an unexpected plot twist. She handled the news with the courage, grit and no-nonsense manner I have cherished for the past 63 years of marriage. As Barbara says, “When life knocks you down, faith and family keep me marching onward and upward.” An incision biopsy revealed a malignant tumor in her left breast.
In April 1987, Barbara had life-saving surgery. Every year since then, she gets an annual mammogram screening and our family gives thanks every day that this resilient woman is a breast cancer survivor. Barbara credits early detection for saving her life and has made advocacy, education and outreach a personal campaign to help save more lives. That plot twist that made our hearts skip a few beats three decades ago opened another chapter for Barbara and myself. We are committed to help raise awareness regarding early detection, wellness and cancer prevention. Barbara and I have served as honorary co-chairs at the John Stoddard Cancer Center booth at the Iowa State Fair. It’s always good to connect with Iowans who take advantage of free cancer and wellness screenings and to share our advocacy for this important public health issue.
According to the Centers for Disease Control and Prevention, one of every four deaths in the United States is due to cancer. More than 500,000 Americans die from cancer every year, the second leading cause of death in our country. We also have enjoyed meeting Iowans and other survivors who participate in wellness walks and other events, especially during Breast Cancer Awareness Month in October. Barbara also serves on the executive committee of congressional families for cancer prevention.
How has the experience of dealing with cancer in your community, both personally and from stories you’ve heard from your constituents, shape your views as a policymaker and a public official?
From a personal perspective, I am a firm believer that healthy habits – getting enough sleep, regular exercise and good nutrition -- are vital to adding years to life and getting the most life out of our years. Barbara’s cancer diagnosis served as a reality check to both of us. It reinforced how important it is to maintain regular wellness checks with a primary care provider, conduct self-exams and not to ignore aches and pains that may flag symptoms of something more serious.
As an elected representative for Iowans, I have made it a mission to keep in touch with my constituents. In fact, I just launched my 38th consecutive year holding meetings in each of Iowa’s 99 counties. Nothing compares to having face-to-face dialogue with my fellow Iowans, no matter the issue, but especially when these conversations involve issues that impact the quality of life and access to affordable health care for a loved one. From that standpoint, I have championed policy measures to keep the delivery of health services accessible to people living in rural and under-served areas of America.
Access to quality health care should not be determined by your zip code. Keeping rural and community clinics and tele-health services open for business is a lifeline to cancer patients who otherwise might have to travel for hours to see a specialist or get lab work done, for example.
What would you say to your colleagues in the legislative branch about the role of federal investment in medical research and cancer research in our nation?
The federal government serves as a check on quality and patient safety through its regulatory responsibilities authorized by Congress. As keepers of the public purse, lawmakers have the authority to channel federal tax dollars towards national priorities and needs, such as medical research. The $6.3 billion 21st Century Cures Act reflects the high priority elected representatives put towards federal investment in innovation, medical science and research studies to accelerate innovative treatments, therapies and cures for the American people diagnosed with chronic conditions and diseases. Specifically, the law authorized nearly $2 billion to accelerate cancer research and improve prevention, earlier detection, survival and ultimately find cures.
How can groups like the AACR and patient advocates best communicate the importance of medical research to the members of Congress? Do you think we have made progress in terms of raising awareness of the importance of National Institutes of Health (NIH) funding to saving lives and helping the American economy?
Patient advocacy groups very definitely make an impact on developing public policy and that bears out in the overwhelming passage of the 21st Century Cures Act in December 2016. The law arguably reflects the best way to gain traction and accelerate legislation to final passage: build broad coalitions. A diverse array of constituencies turned up the volume, from patients and health care providers, to drug and medical device companies, think tanks, medical societies, universities and more.
A sustained and well-orchestrated messaging campaign successfully captured broad bipartisan support on Capitol Hill. Elected representatives have their ears tuned into grassroots advocacy, from constituents attending meetings in their home states or on Capitol Hill, to constituent mail campaigns and social media outreach, patient advocacy groups absolutely bring a big voice to the table. Personal stories also help bring major policy issues down to a human level so hearing from cancer patients, families, and survivors is vital.
The big picture is clear: Americans expect the United States to continue its reputation as a world leader in breakthrough medicine that saves lives, finds cures and improves the quality of life for an aging society. Those expectations require a strategic partnership for medical research among industry, academia and the National Institutes of Health.
Can you tell us more about other efforts—legislation and otherwise—that you have worked on or are currently working on in support of better prevention, detection and treatment of cancer?
From my committee chairmanships of the Senate Aging, Finance and Judiciary Committees, I have conducted robust oversight of public health care programs and federal agencies and advanced legislation to improve the delivery of health care in the United States, particularly to expand access to screening and treatment services for lower-income individuals. My work specific to the prevention, detection and treatment of cancer includes:
In 1997, I helped steer the State Children’s Health Insurance Program S-CHIP program to final passage as a senior member of the Senate Finance Committee. Since its enactment, I have led efforts to reauthorize and expand S-Chip as chairman and ranking member of the Senate Finance Committee. This year Congress extended the program, providing nearly $125 billion to provide coverage through the next six years. This federal-state partnership provides access to health care for children whose families earn too much to qualify for Medicaid. It’s estimated that one-third of children with cancer depend on these two programs for treatment.
Also in 1997, I co-sponsored a resolution adopted by the U.S. Senate calling for accurate, scientific data to determine recommendations for breast cancer screenings, such as a mammography and other emerging technologies, specifically for women ages 40-49.
Since its first issue in July 1998, I have supported many times to extend sales of the USPS breast cancer research postage stamp to help fund breast cancer research. As of Dec. 2017, the stamp has raised more than $87 million for breast cancer research. By federal law, the National Institutes of Health receives 70 percent of the net amount raised and 30 percent is directed to the Medical Research Program at the Department of Defense.
In 2000, I co-sponsored the Breast and Cervical Cancer Prevention and Treatment Act enacted into law on October 24, 2000. It allowed states to make breast and cervical cancer-related treatment and services available to low-income individuals.
In 2007, I co-sponsored the Breast Cancer and Environmental Research Act enacted into law on Dec. 21, 2007. It authorized grants for public and nonprofit entities to conduct research on environmental factors that may be related to breast cancer.
In 2015, I sponsored the Accelerating the End of Breast Cancer Act, securing 53 bipartisan co-sponsors. It would have created a commission to accelerate the end of breast cancer with the goal to end breast cancer by Jan. 1, 2020.
Also in 2015, I co-sponsored the Lymphedema Treatment Act that would provide for Medicare coverage of certain lymphedema compression therapies, a progressive condition that can be caused by cancer treatments, putting survivors at risk of infection, disability and other complications.
In this 115th Congress, I am co-sponsoring the following bills:
The Childhood Cancer Suvivorship, Treatment, Access and Research Act of 2017, the STAR Act to accelerate development of promising childhood cancer treatments.
The ACE Kids Act of 2017 to improve Medicaid program to better coordinate care for children with complex medical conditions, including cancer, that require continuum of care across multiple providers and allowing for flexibility for out-of-state services.
The Reducing Drug Waste Act of 2017; the Preserving Acccess to Affordable Generics Act of 2017; and, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017. These efforts aim to increase consumer choice and help reduce the cost of life-saving drugs for patients.
The Cannabidiol Research Expansion Act of 2017 to reduce regulatory barriers and encourage federal research into the potential medical benefits of cannabidiol oil for medical purposes, such as treating side effects of chemotheraphy.
I also serve as a member of the Congressional Caucus on the Deadliest Cancers (103 members), a bipartisan, bicameral coalition to raise awareness about the deadliest forms of cancer, those with a five-year survival rate of below 50 percent.
The AACR is the world’s first and largest organization dedicated to every aspect of high quality cancer research. The AACR has 40,000 members across all states, as well as members in 119 other countries. Do you have anything you would like to say to the AACR and our scientists and physicians who have dedicated their careers to making progress against cancer?
Imagine the possibilities of a world without cancer. I applaud your dedication and commitment. Know that your vocation and your work makes a difference.
Is there anything we didn’t discuss that you would like to add?
I welcome and value the expertise and advocacy that the American Association for Cancer Research brings to the table. Our republic is made stronger with grassroots engagement and civic participation. That’s one reason I support recognizing May as National Cancer Research Month. All Americans will be impacted by cancer in our lifetimes. Working together we can raise awareness and strengthen resources to continue improving earlier detection and survival rates; advance innovative therapies and treatments; and one day fulfill the hopes and prayers of millions of Americans who are coming to grips with a diagnosis or taking care of a loved one battling this disease by finding cures.
Senator Grassley’s wife, Barbara, is a 30 year breast cancer survivor and a member of the Prevent Cancer Foundation’s Congressional Families Cancer Prevention Program.
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Interpreting the False Claims Act
Prepared Senate Floor Statement by Senator Chuck Grassley of Iowa, Chairman, Senate Judiciary Committee
February 13, 2018
Today I want to talk about some troubling developments in the courts’ interpretation of the False Claims Act. To understand these developments, we need to review a little history.
In 1943, Congress gutted the Lincoln-era law known as the False Claims Act. At the time, the Department of Justice said that it needed no help from whistleblowers to fight fraud. The Department said that if the government already knows about the fraud, no court should even hear a whistleblower’s case. So, Congress amended the False Claims Act to bar any whistleblower from bringing a claim if the government knows about the fraud.
That was a mistake.
The bar led to absurd results that only hurt the taxpayer. It basically meant that all whistleblower cases were blocked, even cases where the government only knew about the fraud because of the whistleblower.
In 1984 the Seventh Circuit barred the State of Wisconsin from a whistleblower action against Medicaid fraud. Wisconsin had already told the federal government about the fraud—because it was required to under federal law. So, because of the so-called “government knowledge bar,” whistleblower cases went nowhere and neither did prosecution of wrongdoers.
In 1986 I worked with my colleagues to make it possible for whistleblowers to be heard again. That included eliminating this so-called “government knowledge” bar. Since then, what the government knows about a fraud has still been used by defendants in False Claims Act cases, as a defense against their own state of mind.
Courts have found that what the government knows about fraud can undercut allegations that defendants knowingly submitted false claims.
The theory goes something like this: If the government knows about the defendant’s bad behavior, and the defendant knows the government knows, then the defendant did not knowingly commit fraud. Once you wrap your head around that logic puzzle, I’ve got another one for you.
In 2016, the question of what the government knows about fraud in False Claims Act cases began to take center stage once again. In Escobar, the Supreme Court rightly affirmed that a contractor can be liable under the “implied false certification” theory. That just means a contractor can be in trouble when it doesn’t make good on its bargain. And it doesn’t matter whether the contractor outright lies. A misleading omission of its failures is enough.
Unfortunately parts of the Court’s ruling are getting some defendants, and judges, tied in knots.
Justice Thomas wrote that the false or misleading aspect of the claim has to be material to the government’s decision whether to pay it. Thomas said that one of several ways you can tell whether something misleading is also material is if the government knows what the contractor is up to and pays the claim anyway.
At first glance, I suppose that makes sense. If someone gives you something substantially different in value or quality than what you asked for, why would you pay for it? But if the difference really isn’t that important, you might still accept it.
Even if that is true, the problem here is that courts are reacting the way they always have. They are trying to outdo each other in applying Thomas’ analysis inappropriately or as strictly as possible – to the point of absurdity. In doing so, they are starting to resurrect elements of that old “government knowledge” bar I worked so hard to get rid of.
This is what the Justice actually wrote:
“[I]f the Government pays a particular claim in full despite its actual knowledge that certain requirements were violated, that is very strong evidence that those requirements are not material. Or, if the Government regularly pays a particular type of claim in full despite actual knowledge that certain requirements were violated, and has signaled no change in position, that is strong evidence that the requirements are not material.”
He did not say that in every case, if the government pays a claim despite the fact that someone, somewhere in the bowels of the bureaucracy might have heard about allegations that the contractor may have done something wrong, the contractor is automatically off the hook.
Think about it. Why should the taxpayer pay the price for bureaucrats who fail to expose fraud against the government?
That’s why the False Claims Act exists, to protect taxpayers by rewarding whistleblowers for exposing fraud.
Justice Thomas said that the government’s actions when it has actual knowledge that certain requirements were violated are evidence of whether those requirements are material—or not.
What does it mean for the government to have actual knowledge? Would it include one bureaucrat who suspected a violation but looked the other way? Would that prove the requirement was material?
Courts need to be careful here.
First, this statement about government knowledge is not the standard for materiality. The standard for materiality is actually the same as it has always been. The Court did not change it in Escobar.
Materiality means “having a natural tendency to influence, or being capable of influencing, the payment or receipt of money or property.”
The question of the government’s behavior in response to fraud is one of multiple factors for courts to weigh in applying the standard.
Second, courts and defendants should be mindful that Justice Thomas limited the relevance here to actual knowledge of things that actually happened. There are all sorts of situations where the government could have doubts—but no actual knowledge of fraud.
Maybe the government has only heard vague allegations, but has no facts. Maybe the rumors are about something that may be happening in an industry, but nothing about particular false claims by a particular defendant. Maybe an agency has started an inquiry, but still has a long way to go before it’s finished. Maybe someone with real agency authority or responsibility hasn’t learned of it yet.
There are a lot of situations where the government might not have actual knowledge of the fraud
Third, even if the government does pay a false claim, that is not the end of the matter. Courts have long recognized there are a lot of reasons why the government might not intervene in a whistleblower case.
And, there are a lot of reasons why the government might still pay a false claim. Maybe declining to pay the claim would leave patients without prescriptions or life-saving medical care.
Paying the claims in that case does not mean the fraud is unimportant. It means that, in that moment, the government wants to ensure access to critical care. That payment cannot, and does not, deprive the government of the right to recover the payment obtained through fraud.
Can you imagine if that were the rule, though? Can you imagine if providers could avoid all accountability because the government decided not to let someone suffer? Then fraudsters could hold the government hostage.
They could submit bogus claims all the time with no consequences because they know the government is not going to deny treatment to the sick and vulnerable.
That is just not what the False Claims Act says. Courts should not read such a ridiculous rule into the statute.
Fourth, courts should take care in reading into the Act a requirement for the government to immediately stop paying claims or first pursue some other remedy. There could be many important reasons to pay a claim that have nothing to do with whether the fraud is material.
Further, there is no exhaustion requirement. The False Claims Act does not require the government to jump through administrative hoops or give up its rights. And that would be an unreasonable burden on the government in any event.
We have decades of data showing that the government cannot stop fraud by itself. I also know from many years of oversight that purely administrative remedies are very time consuming and often toothless.
The government should be able to decide how best to protect the taxpayers from fraud. The FCA is the most effective tool the government has.
The government should be able to use it, without the courts piling on bogus restrictions that are just not in the law.
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Minority Leader’s objections to debating immigration
Floor Statement by Senator Chuck Grassley of Iowa, Chairman, Senate Judiciary Committee
February 13, 2018
About 20 minutes ago, our Majority Leader, Senator McConnell tried to move debate along on an immigration bill, and I’m puzzled that the Minority Leader, Senator Schumer, objected. And the reason I’m puzzled is because, for a long period of time, people on both sides of the aisle have been advocating for certainty for the young people brought here by their parents that we call Dreamers or DACA people.
And so the Majority Leader, two weeks ago, promised the Minority an opportunity to have a debate on that issue. The first debate on immigration since 2013, I believe. The Majority Leader today tried to carry out that promise to get this bill moving, and we have this objection. Very puzzling.
I think it’s legitimate to ask the Minority Leader why this objection is coming for the very debate that he and his side of the aisle have been demanding from the Majority for a long, long period of time. Hasn’t the Minority Leader and the entire Democratic Party been asking for this debate on immigration for months? Yes, they have been.
Leader McConnell has honored his commitment and allowed us to have an open, fair immigration debate this week. The key word here is an ‘immigration’ debate. Not a DACA-only debate. Not an amnesty-only debate. An immigration debate.
An immigration debate has to include a discussion about enforcement measures. An immigration debate has to include a discussion about how to remove dangerous criminal aliens from our country. A real immigration debate has to include discussions about how to protect the American people.
The Leader has asked for unanimous consent to allow us to start debating these issues, and the Democrats are refusing.
Puzzling, as I say it is, because they have been the ones to demand to have this debate. Why don’t they want to debate things like sanctuary cities?
Are they unprepared to discuss this vital public safety issue? Or, is it more likely that they are worried that an enforcement bill from this side of the aisle could actually pass? Maybe that’s the case, but it’s no reason to not allow this body to start the debate on that important issue.
The American people deserve a real immigration debate, about the four pillars that we agreed to at the White House, and not just a debate about the Democrat’s preferred policy preferences. Yes, DACA is a part of that discussion, but it’s only one part. If the Democrats are insisting we debate their preferred policies only, well that’s not a real debate at all.
We have filed an amendment that takes into consideration the four pillars that were agreed to at a bicameral, bipartisan meeting at the White House with the President presiding on January 9. Those four pillars include legalization and a path to citizenship, border security, elimination of chain migration and fourthly elimination of the Diversity Visa lottery. Those all fit in, maybe not exactly in detail the way the President might want it, but they fit into the four that he said he would sign on to.
So I suggest to my other 99 colleagues that there is a provision that can pass the United States Senate, can pass the House of Representatives and can be signed by the President because he has said he agrees with those principles. Other people have bills, but not something that can become law based upon what the President will sign or not sign.
So I think that it’s, again, very puzzling why the Democrat leadership will not allow this debate to go forward, something that they’ve been asking for. More importantly, maybe quite to their surprise, the Majority Leader has allowed the debate to move forward. That’s how a consensus was made two weeks ago on the issue of opening up government and having this debate and moving forward to a budget agreement. Those things have been done.
Now the Leader is carrying out his promise, I hope the other side will agree to move ahead.
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