[Congressional Record Volume 155, Number 89 (Monday, June 15, 2009)]
[Senate]
[Pages S6582-S6585]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KYL (for himself, Mr. McConnell, Mr. Roberts, and Mr. 
        Crapo):
  S. 1259. A bill to protect all patients by prohibiting the use of 
data obtained from comparative effectiveness research to deny coverage 
of items or services under Federal health care programs and to ensure 
that comparative effectiveness research accounts for advancements in 
personalized medicine and differences in patient treatment response; to 
the Committee on Health, Education, Labor, and Pensions.
  Mr. KYL. Mr. President, I wish to talk about a bill Senator McConnell 
and I introduced today. I think a companion bill will also be 
introduced by some of the leadership in the House of Representatives. 
The number of the bill is S. 1259, and this bill is called the PATIENTS 
Act--``patient'' as in doctor-patient. The idea is to focus on health 
care as it relates to patients.
  Health care reform should be patient centered. Nothing should come 
between the physician and the patient. We are concerned there is 
something being done that we need to stop because it could, in fact, 
insert government bureaucracies between the patient and the physician. 
What has happened is that in the stimulus bill, the Congress 
appropriated $1.1 billion for something called comparative 
effectiveness research. Comparative effectiveness research has been 
used for years by physicians and hospitals. Medical schools do 
research, and they determine what kinds of treatments are best. For 
example, if you have two different drugs for the same condition, they 
will do testing to see which one seems to work the best. It is called 
clinical trials. They do clinical research, and physicians and 
hospitals frequently use that research as recommended for the best way 
to treat a particular condition. It is not mandatory. Obviously, what 
is good for most patients may not be good for all patients. So it is 
not something that is obviously forced upon people, but it provides 
good information. The problem is that too many people now who are 
proposing health care reform want to use comparative effectiveness 
research to end up rationing care, to have a Federal entity or even a 
State entity, or I should say a private entity, use that research in 
ways that would end up rationing care, to say some care is just too 
expensive for you to have, and since the government is paying for it, 
the government is not going to give it to you.
  What our bill would do is make it clear that comparative 
effectiveness research cannot be used to deny coverage of either a 
health care service or treatment by the Secretary of HHS. And we say 
the Secretary of Health and Human Services because all of the various 
entities that might do that in the Federal Government are part of HHS. 
So we simply prohibit the Secretary of HHS from using this comparative 
effectiveness research to deny

[[Page S6583]]

health care service or treatment. You would think that would be 
uncontroversial, and I am hoping at the end of the day that it is not 
controversial. Nobody wants their health care rationed by somebody here 
in Washington, DC.
  It would also require that comparative effectiveness research account 
for differences in the preference of patients and their treatment 
response to personalized medicine on something called genomics.
  Genomics is the breakdown of the genes in the body into all of the 
different elements which make us unique as individuals. What genomics 
research focuses on is, what exactly is it in your gene composition, 
the human genome, that might be different from someone else's that 
means that a personalized treatment would work for you whereas it might 
not work for someone else. They are actually finding that they can 
tailor specific drugs to treat specific genes in such a way that, if 
they know your human composition, they can find a way to treat your 
condition--say, a cancer--potentially slightly differently than they 
would treat someone else's cancer, whether it is in the dosage of the 
medicine or in the specific kind of medicine or however it might be--
the point being that not everyone is the same. In fact, we are all 
different, we are all unique, and one of the things medicine must 
recognize is our uniqueness as individuals and not get into the habit 
of saying that there is a sort of a size that fits all here, and we are 
going to say that if doctors will treat everyone with this particular 
medical device or drug or treatment, then we will pay for it, but we 
are not going to pay for it if they do anything else. That would not be 
good medicine. That inserts the government between the doctor and the 
patient. So we say that can't be done using this comparative 
effectiveness research.
  By the way, the bill also makes clear that nothing prohibits the FDA 
Commissioner from responding to drug safety concerns under his 
authority. Obviously, if a drug is not safe, the FDA needs to say the 
drug is not safe and the Federal Government is not going to pay for it. 
That is obvious.
  But the point is that this comparative effectiveness research should 
not be used by the government to deny or delay or to ration care. The 
reason for it is, obviously, we all want to be in charge of our own 
health care with our doctor. We want the choice. If a doctor says: We 
think you need this kind of treatment and we can get coverage for that 
from our insurance, we want to be able to get that care. If we cannot, 
we want to try to find insurance that will provide that kind of 
coverage for us. At least at a minimum, we want to be able to pay for 
the treatment, if nothing else. What we do not want is for the Federal 
Government to say that it does not matter if you want to pay for it, it 
does not matter if you are covered, you cannot get it because the 
Federal Government says so.
  This is especially important if we have a government-run insurance 
company, which is what many on the other side of the aisle are talking 
about.
  The President has said he wants a so-called public option so there 
will be a government insurance company that will be a place where 
everybody could go for coverage if they don't have it. I happen to 
think there are better ways of getting everybody covered. To the extent 
we have some people who need help in getting coverage, the government 
can provide that help without changing the kind of coverage all the 
rest of us have. Surveys show, by about two to one, Americans believe 
we should help people get insurance who don't have it. But by the same 
rough numbers, everybody says: However, you don't need to affect my 
coverage in order to do that. In other words, I have insurance. I like 
it. I want to keep it. I don't want to change. I don't want to have to 
pay through my insurance or through having care rationed in order to 
make sure somebody else gets care. The bottom line is, we all want that 
sacred doctor-patient relationship maintained.
  One might ask: Why would we be worried that this comparative 
effectiveness research might be used to ration care? Is there anything 
in the legislation that suggests this is going to happen? As it turns 
out, in both the bill that came from the HELP Committee and the 
legislation that will be drafted in the Finance Committee, there are 
organizations that are going to do this research that could, in fact, 
ration care. In the HELP Committee bill, there is a specific provision 
that a government entity is going to be created to conduct this 
research and nothing whatsoever prohibits that entity from denying care 
based upon the application of rationing. The same is true under the 
plan talked about in the Finance Committee. There a private entity is 
organized, but there is nothing that would prevent the Federal 
Government from rationing the care that is researched by the private 
entity.
  The HELP Committee creates what it calls the agency for health care 
research and quality in the Department of Health and Human Services. In 
the Finance Committee, it is a private research entity. But in neither 
case is the Federal Government prohibited from using this comparative 
effectiveness research in rationing care.
  In addition, the HELP Committee bill establishes a medical advisory 
council. The medical advisory council is specifically given very broad 
authority to make recommendations on health benefits coverage; in other 
words, what is covered by the Federal Government. Obviously, when the 
Federal Government sets rules, insurance companies frequently apply 
those same kind of rules. We don't want the government, rather than 
patients and doctors, making decisions about how much health care or 
what health care one would have.
  Another point I have tried to make to colleagues is, if they think 
the Federal Government isn't considering this, think about what some 
people have said in the Federal Government about allocating treatment 
based upon cost. No less than the Acting Director of the National 
Institutes of Health, Raynard Kington, announced that the NIH could use 
this stimulus money, money in the so-called stimulus bill that pays for 
comparative effectiveness research, to ration care just as is done in 
other countries. The NIH released a list of research topics and called 
for the inclusion of rigorous cost effectiveness analysis because 
``cost effectiveness research will provide accurate and objective 
information to guide future policies that support the allocation of 
health resources for the treatment of acute and chronic diseases.'' 
``Allocation of resources'' is a euphemism for rationing of health 
care. Similar statements have been made by Larry Summers. Frankly, the 
President himself has talked about this, not in those specific terms, 
but in a recent interview with the New York Times he said:

       What I think government can do effectively is to be an 
     honest broker in assessing and evaluating treatment options.

  If the government is going to be a broker in treatment options, that 
also is a euphemism for deciding what it is going to pay for and what 
it will not. In other words, what one can and cannot get.
  When a former Senator and at one point candidate for HHS Secretary 
talked about this, he acknowledged in a book he wrote that doctors and 
patients might resent any encroachment on their ability to use certain 
treatments, but he called for the same kind of body in his book that 
would, in effect, allocate treatments based upon this kind of cost 
research.
  There are many others who have spoken about it as well. We know from 
experience that this hasn't worked out so well in countries that have 
tried it such as Great Britain and Canada. In fact, I will quote one 
other individual who has talked about this, a professor at the Harvard 
Business School. Regina Herzlinger said that the comparative 
effectiveness research in the stimulus bill could easily morph into 
what she called ``an instrument of health care rationing by the federal 
government.''
  There are comparisons to what is being done in Great Britain and 
other European countries and Canada; ironically, at a time when those 
countries are actually turning away from the federal monopoly or the 
national monopoly because of the fact that it has resulted in rationing 
of care that the citizens of those countries don't like.
  A former head of the American Medical Association, which has endorsed 
the legislation Senator McConnell and I are introducing, said in an op-
ed in the Chicago Tribune today, talking about the British agency, for 
which, ironically, the acronym is NICE:

       For example, the agency that makes these decisions in the 
     United Kingdom determined

[[Page S6584]]

     that we are all worth $22,750 or six months of life or $125 a 
     day. I'm sorry. But $125 is the cost of a nice date with my 
     wife, not the value of my life.

  What he is talking about is something called quality adjusted life 
years which is the British definition of the value they are going to 
place on a life for the purpose of comparing the cost done by this cost 
effectiveness research to see whether the cost of the treatment 
outweighs the value of the life. Think about that. Let me quote from 
the NICE Web site. It stands for National Institute for Health and 
Clinical Excellence, NICE. Here is what it says on Great Britain's Web 
site:

       With the rapid advances in modern medicine, most people 
     accept that no publicly funded health care system, including 
     the NHS, can possibly pay for any new medical treatment that 
     becomes available.

  If the Federal Government has a monopoly, it probably doesn't have 
enough money to pay for every treatment that becomes available. It goes 
on to say:

       The enormous costs involved mean that choices have to be 
     made.

  That is why they ration care in Great Britain. It goes on:

       The QALY [quality-adjusted life year] method helps us 
     measure these factors so we can compare different treatments 
     for the same and different conditions.

  It is an idea of how much extra months or years of life of reasonable 
quality a person might gain as a result of the treatment.

       Each drug is considered on a case-by-case basis. Generally, 
     however, if a treatment costs more than 20,000 to 30,000 
     pounds per [quality-adjusted life year], then it would not be 
     considered cost effective.

  And they don't give it to you.
  We have many examples of people in Great Britain who are denied care 
because the government has decided that the cost of the treatment is 
more than the quality-adjusted life year. This is adjusted for age so 
that the older you get, even though the treatment may cost less, you 
are less likely to get it because of your age. Think about that for a 
moment. If something costs $20,000 in the United States and you are 65 
years of age and they decide that they can't afford to pay for it, is 
that what the United States of America is all about? Is that what our 
government should be telling us? Should the government have the right 
to say: Based on this research we have done, you can't have that 
treatment?
  If you believe that can't happen in the United States, I think it 
can. It has happened in Great Britain and Canada. Our legislation says 
it can't. So what is the harm in adopting our legislation? That is the 
question I will be asking of anyone who says is it not necessary.
  I want to put the question: Then what harm does it do to say that 
this research can't be used by the Federal Government to deny or delay 
treatment? I hope my colleagues will appreciate that health care is the 
most important thing to all of us for our families. Whatever else we 
may think needs to be done to reform health care, the one thing we can 
all agree on is, it should not result in rationing of health care for 
Americans. Our legislation is one step in that process. It doesn't 
preclude rationing of health care in other ways. But at least it says 
comparative effectiveness research cannot be used in order to ration 
care. I hope our colleagues will view this legislation as an important 
step we can take.
  Let me give a couple examples I said I would provide. There is a 
fellow by the name of Rocky Fernandez, a kidney cancer patient in 
Britain. He was given 2 months to live when the cancer spread to his 
lungs. His doctor wanted to prescribe a drug called Sutent, a new drug 
for advanced kidney cancer, but the government said no. He and 
thousands of other cancer patients protested the government's decision. 
This is what you would have to do, I gather. The government ultimately 
reversed its decision and, fortunately, he was able to begin taking the 
drug. The British health authorities knew this wasn't the end, that as 
more costly life extending drugs would become available, patients would 
demand access to the drugs and the government would be faced with 
increasingly difficult decisions. So faced with a finite pot of 
resources, the British health authorities decided that expensive drugs 
like Sutent would only be approved under specific conditions: They must 
extend life by 3 months, and they must be used for illnesses that 
affect fewer than 7,000 patients a year.
  Is that what we want in the United States? Before you could get a 
drug that would give you better quality of life or extend your life, 
the government is going to run through tests like this. And if it 
doesn't meet the test, you don't get the drug? This is the danger of a 
government-run system. In effect, bureaucrats in the government become 
health care cops. We don't want that in America.
  In the reform legislation that we end up acting on, I hope we can all 
agree that one of the things we can do to prevent this rationing is to 
at least say we will do no harm. We will not allow this comparative 
effectiveness research to be used by the Federal Government to deny our 
care.
  I ask unanimous consent to print in the Record the op-ed from the 
Chicago Tribune by Dr. Palmisano from which I quoted earlier.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

               [From the Chicago Tribune, June 15, 2009]

           Reform Measures Should Not Weaken Our Health Care

                        (By Donald J. Palmisano)

       Over the past several decades, our nation has built the 
     finest health-care system in the world. From birth to death 
     we value and care for life. Surgeons can perform life-saving 
     heart surgery on a child that is still in utero. Expert 
     trauma doctors can save the life of a mother who was badly 
     hurt in a car crash. And end-of-life specialists can provide 
     compassionate palliative care to seniors to ensure their last 
     days are spent in comfort.
       This didn't all just magically happen. But it could all 
     magically go away.
       Swirling around us is a great debate that will decide the 
     future of medical care in America. There are those who desire 
     a single-payer system, although the ``single payer'' would be 
     the 100 million Americans who pay taxes. It would leave the 
     government in charge of our medical choices. But since 
     single-payer advocates know the majority of Americans oppose 
     such a system, they have decided to advance an alternative--
     known as the public option.
       Either approach would seriously weaken the health-care 
     system we enjoy today. The public option would cost $1.2 
     trillion to $1.8 trillion to set up. Is that something our 
     nation can afford, especially considering the latest 
     estimates that Medicare is going to be bankrupt in 10 years?
       Is it the goal of some individuals to eventually wipe out 
     all private insurance plans and house all health care under 
     the umbrella of the federal government? These types of 
     government-controlled systems already exist in other 
     countries, and all have stories of patients who had to wait 
     months to see specialists. It's common to hear of patients 
     who were not allowed to get the treatment their doctor 
     prescribed because a bureaucratic decision was made on the 
     value of their life. For example, the agency that makes these 
     decisions in the United Kingdom determined that we are all 
     worth $22,750 for six months of life--or $125 a day. I'm 
     sorry, but $125 is the cost of a nice date with my wife, not 
     the value of life.
       The American Medical Association, representing more than 
     250,000 physicians, and an organization I once led, recently 
     came out in opposition to the proposed public plan, saying 
     that it ``threatens to restrict patient choice'' and that it 
     ``would likely lead to an explosion of costs that would need 
     to be absorbed by taxpayers.''
       That position comes from studying government-controlled 
     health care elsewhere. During my year as president of the 
     AMA, I was able to visit and see firsthand the success and 
     failures of other health-care systems. I recall meeting with 
     the chairman of the British Medical Association in June 2003, 
     when he characterized his nation's single-payer health-care 
     system as ``the stifling of innovation by excessive, 
     intrusive audit . . . the shackling of doctors by prescribing 
     guidelines, referral guidelines and protocols . . . the 
     suffocation of professional responsibility by target-setting 
     and production line values that leave little room for the 
     professional judgment of individual doctors or the needs of 
     individual patients.''
       And what else will happen when the government asserts its 
     control over health care? Medical creativity, discovery and 
     innovation--the same creativity and discovery and innovation 
     that we have relied on for generations--will dry up. Today, 
     millions of Americans rely on statins to reduce their risk of 
     heart attack. The new da Vinci surgical system is already 
     revolutionizing the way surgery is performed in operating 
     rooms across the country. And wounded veterans are being 
     fitted with next-generation prosthetic limbs so they can walk 
     again.
       Only in America.
       We must find ways to expand access to affordable health 
     care to the uninsured. America can solve the current problems 
     with a system that expands insurance coverage through tax 
     credits, consumer choice and market enhancements. However, in 
     the process of expanding care, we cannot create a weaker 
     system for the 80 percent of Americans who are happy with 
     their coverage. It

[[Page S6585]]

     would be a serious mistake to have a government-controlled 
     micromanaged medical system that would result in diminished 
     quality of care, long waiting lines for doctors' visits and 
     surgical care, a lack of access to emerging technologies and 
     the virtual end to new and hopeful medical discovery. Health 
     care shouldn't be dictated to us by a faceless bureaucrat in 
     Washington.
       A lot is at stake as the nation engages in the health-care 
     debate. Will we have a system that puts the patient in 
     control with the doctor as trusted adviser, or a government-
     run system that ultimately rations care and stifles 
     innovation and self-determination? I hope it's the former.

  Mr. KYL. We have actually seen the danger in using this kind of 
research for rationing of care in another context. When we created 
Medicare Part D, which provides drugs to seniors, we saw the danger of 
rationing of drugs, and so we specifically provided, in the Medicare 
Modernization Act, an explicit provision that says you can't use cost-
effective analysis to allocate the drugs. It is prohibited there. What 
we should do is take that same policy and apply it to the rest of our 
health care, to seniors who are on Medicare and to the rest of the 
population, to the extent the Federal Government will be able to 
dictate its care. We have not provided that same protection for any 
other care, and that is what our legislation, the PATIENTS Act, would 
do.
  The final thing I wish to discuss is the notion that we can have a 
government-run insurance plan and that somehow that will be healthy for 
Americans. Stop and think, a government-run option or government option 
would be the Federal Government making decisions about care. So while 
you may decide it is a lot cheaper because the Federal Government can 
subsidize the insurance plan, the government will actually be deciding 
what kind of coverage you get. This is one of the areas we are 
concerned about in using this comparative effectiveness research. 
Because clearly the so-called public option, in order to keep costs 
down, could end up rationing care. That is OK if it is merely an option 
and people figured out, wait a minute, even though it is cheaper, I 
don't want this. But what Lewin and Associates, a health care 
consulting group, says is that unfortunately, because private employers 
are likely to dump their employees into the government-run system, 
about two-thirds of the people who have insurance today, 119 million 
people, would end up with the government-run plan rather than the 
private insurance they have today. When the President says, if you like 
your insurance coverage, you get to keep it, I hope what he means is 
that we won't do anything in our legislation to make that more 
difficult.
  But if, in fact, the predictions of consulting groups such as Lewin 
come true, what will happen is, employers, faced with the situation 
where it is much cheaper for them to insure their employees through 
this government-run plan, will take 119 million people and transfer 
them from private insurance to government insurance. At that point, you 
do not have any option. So the government-run plan is not like it is an 
option for you, unless you want to change jobs to an employer that is 
willing to maintain the coverage. And those are going to be few and far 
between. The same thing is true with the individual health care market.
  The bottom line is, when people say to you: Well, if you like your 
coverage, you are going to be able to keep it, that is not true. 
Incidentally, under the bill that is being written by the Finance 
Committee, that is explicitly not true either. That is why we are 
concerned about this. Because even though you may like the insurance 
you have today and say: The Federal Government can't tell me what care 
I can get, it will not be too much longer before that may not be true. 
You will have the government insurance, and it will tell you what care 
it can give you.
  When we talk about the fact that we are eager for health reform, what 
we are talking about is allowing people to keep their current coverage; 
allowing them to take their coverage with them; that is to say, it is 
portable when you leave one job and you go to another job, to make sure 
you cannot be denied care because you have a preexisting condition; and 
if you need financial help in getting insurance, to find a way to 
provide that financial help.
  We believe those are better solutions to making sure everyone is 
insured than providing a public option. It is a little like the 
government taking over General Motors. The only difference is, it is 
one thing if the people who are now running General Motors make a 
mistake. It is usually not going to be a life-or-death situation. But 
it is a whole new ball game if the government is deciding you cannot 
get a particular drug or a particular kind of surgery that your doctor 
says you need.
  The bottom line is, Washington-run health care has significant 
dangers in it--more than if you are going to run the insurance 
companies or the car companies or the banks. When you have a Medical 
Advisory Council, as the HELP Committee legislation provides, or a 
National Institute for Health and Clinical Excellence--NICE--as in 
Great Britain, it is anything but nice when your health care is denied 
to you.
  What we are trying to prevent by this legislation, for the final 
time, is a situation where the government is in a position to tell you 
that you cannot have a certain drug or treatment or device your doctor 
has said you need because they use this comparative effectiveness 
research to say: Well, in your case, you are not going to live much 
longer anyway. It is not cost effective for us to buy that for you.
  That is not the American way. As I said, it is ironic countries such 
as Canada and Great Britain are actually beginning to now provide 
private alternatives because they know they cannot take care of all 
their citizens, and they know there is a revolt going on in their 
countries about people who are not getting the care they need. So the 
safety valve for that is to provide an option for the private sector to 
actually provide for this coverage.
  Why would we want to replicate their basic mistake in so-called 
health care reform? There are easier, less costly, and less harmful 
ways to do that than the legislation that is being proposed that would 
allow comparative effectiveness research to ration your care.
  I hope my colleagues will take a look at our legislation, S. 1259. If 
they would like to cosponsor it, we would love to have support because 
when this issue gets to the floor, we will want our colleagues to weigh 
in and send a very strong message that comparative effectiveness 
research is great but it is not good if it is used to deny care or to 
ration care to the American people. That we have to put an absolute 
stop to right now, and our legislation would do that.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 1259

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Preserving Access to 
     Targeted, Individualized, and Effective New Treatments and 
     Services (PATIENTS) Act of 2009'' or the ``PATIENTS Act of 
     2009''.

     SEC. 2. PROHIBITION ON CERTAIN USES OF DATA OBTAINED FROM 
                   COMPARATIVE EFFECTIVENESS RESEARCH; ACCOUNTING 
                   FOR PERSONALIZED MEDICINE AND DIFFERENCES IN 
                   PATIENT TREATMENT RESPONSE.

       (a) In General.--Notwithstanding any other provision of 
     law, the Secretary of Health and Human Services--
       (1) shall not use data obtained from the conduct of 
     comparative effectiveness research, including such research 
     that is conducted or supported using funds appropriated under 
     the American Recovery and Reinvestment Act of 2009 (Public 
     Law 111-5), to deny coverage of an item or service under a 
     Federal health care program (as defined in section 1128B(f) 
     of the Social Security Act (42 U.S.C. 1320a-7b(f))); and
       (2) shall ensure that comparative effectiveness research 
     conducted or supported by the Federal Government accounts for 
     factors contributing to differences in the treatment response 
     and treatment preferences of patients, including patient-
     reported outcomes, genomics and personalized medicine, the 
     unique needs of health disparity populations, and indirect 
     patient benefits.
       (b) Rule of Construction.--Nothing in this section shall be 
     construed as affecting the authority of the Commissioner of 
     Food and Drugs under the Federal Food, Drug, and Cosmetic Act 
     or the Public Health Service Act.
                                 ______