PATIENTS Act of 2009

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

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

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.

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.

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

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

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.

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.

Mr. President, today I am, along with Senators Voinovich, Leahy, Tester, Baucus, and Carper, introducing the Providing for Additional Security in States' Identification Act of 2009, or the PASS ID Act.

This bill represents a pragmatic approach to resolving many of the most troubling aspects of the REAL ID Act, which has been in place for the past 4 years. REAL ID was intended to implement the 9/11 Commission's recommendation for enhancing the security of drivers' licenses. I support the 9/11 Commission's recommendation, but I have been a long-time opponent of the existing REAL ID Act due to the tremendous financial burden it imposes on States and the serious privacy risks it creates.

Initially, DHS estimated the cost of implementing REAL ID to be $23 billion, of which $14 billion would be borne by the States. In the final regulations, DHS's overall cost estimate decreased to $10 billion, $4 billion of which States would have to pay. Many States are facing serious budget shortfalls and simply cannot afford this cost.

Additionally, REAL ID calls for all States to store copies of individuals' documents such as birth certificates and their photographs in databases and to provide all other State Departments of Motor Vehicles with access to that information. REAL ID does not require any privacy protection of these State databases, which would contain massive amounts of personal information. These databases could provide one-stop shopping for identity thieves and the backbone for a national identification database.

Because of these problems, the Department of Homeland Security has been forced to provide a series of extensions for compliance. All 50 States plus the District of Columbia and the territories were granted extensions until December 31, 2009. DHS may automatically grant States further extensions to May 11, 2011, if they meet certain benchmarks for compliance. Under the final regulations, complete implementation is required by December 1, 2017. Even under this drawn out timeline, it is unclear if many States will comply. Several States, including Hawaii, have passed resolutions expressing their opposition to REAL ID. Eleven States have outright rejected REAL ID, putting millions of Americans at risk of not being able to enter Federal facilities or board commercial airplanes next year if they do not meet DHS benchmarks. Americans' personal information could also be compromised if REAL ID were to fully take effect in its current form. This simply cannot be allowed to happen.

Because of my grave concerns with the REAL ID program, during the last Congress, I along with several of my colleagues introduced the Identity Security Enhancement Act, which would have repealed the REAL ID Act and replaced it with a negotiated rulemaking process that would have enhanced the security of State driver's licenses while also providing for strong privacy protections. Unfortunately, this bill did not advance, and we are now closer than ever to forcing states to ensure compliance with REAL ID.

I along with my colleagues, the Department of Homeland Security, privacy and civil liberties groups, and the National Governors Association and National Council of State Legislators--representing a broad range of views on REAL ID--have been working together to develop a bill that will address the onerous problems with REAL ID in a practical manner that can win bipartisan support. I believe that the bill we are introducing represents a pragmatic alternative to REAL ID, which will save States considerable money and address the most troubling aspects of the REAL ID Act.

The PASS ID Act does exactly what the 9/11 Commission recommended: it sets strong security standards for the issuance of identification cards and driver's licenses. What it does not do is go far beyond that recommendation by requiring the collection of Americans' personal information and storing it in a centralized repository accessible by any State government. This legislation starts with repealing the existing flawed REAL ID Act, and replaces it with a modification of the original act that peels away the most troubling aspects that add high costs without real security benefits, and implements strong new protections to protect the privacy rights of individuals.

Perhaps the most important improvement in the PASS ID Act is the removal of the mandate that States share all of their driver's license data with each of the other States. This provision created a clear risk to the privacy of all Americans' personal information and posed a great risk for identity theft and fraud. Moreover, it was this provision that raised the specter of a national database of all Americans' personal information. The PASS ID Act instead will allow States to continue to maintain their own individual databases with more stringent security requirements.

In addition, the PASS ID Act includes all of the privacy protections called for in my previous bill, the Identity Security Enhancement Act. The bill calls on the States to put procedures in place to protect information that is stored or transmitted in an electronic format. The bill also for the first time protects any machine readable data stored on identification cards and driver's licenses themselves. In particular, Social Security numbers, which are not allowed to be printed on the face of a license, would no longer be allowed to be stored in the machine readable zone, MRZ, of a license either.

Because of the ability of licenses to hold more and more electronic information, it is also important to institute important new protections for the use of the data stored on licenses. A new industry is growing up surrounding the collection and sale of data stored in MRZs for marketing purposes. Often people are not informed that their personal information is being collected and might be tracked with their purchases or sold to third parties. This bill would allow scanning of licenses to support law enforcement purposes but not for other purposes. For example, a store would be able to scan a driver's license to double check that the patron is old enough to buy alcohol, but it would not be allowed to sell the information on the card to marketers. This is an important step forward to ensure that privacy and security protections keep pace with technology, while still ensuring that the MRZ can be used for its intended purposes.

The other change that I want to point out is the clarification of Americans' right to travel on commercial aircraft and to enter Federal buildings. The current law restricts these rights by requiring a REAL ID to board commercial aircraft and to enter Federal buildings. This bill recognizes the importance of secure identification to increase the safety and security of commercial air travel and a narrower range of Federal buildings. Compliant State identification will remain the preferred method to board an aircraft, but the PASS ID Act will clarify that people cannot be denied boarding solely because they lack secure identification. The Transportation Security Administration will resolve any security concerns with people lacking a PASS ID the same way they resolve other security issues--with additional screening or other inquiries as needed. Additionally, PASS ID would narrow the secure identification requirement from all Federal buildings to only Federal facilities containing mission functions critical to homeland security, national security, or defense.

This bill does not address all of my concerns with REAL ID. Some others will be disappointed that it does not address all of their concerns. However, the reality that we face is that in less than a year, States will be required to comply with a law on the books that simply is overly burdensome and unworkable. I believe that the legislation introduced today is the best bill that can garner broad bipartisan support. It represents a strong step toward fixing the most serious shortfalls in the REAL ID Act and would introduce long-overdue, important new protections. We cannot let the perfect be the enemy of the good, especially when we are working to address a seriously flawed law already on the books.

I urge my colleagues to talk to your Governors and other State government officials, your constituents, and to privacy experts to understand just how much this legislation does to improve existing law. By taking the time to work with all stakeholders, I think that we have achieved a solution that leaves us much better off than we are today.

As always, my goal remains to ensure the privacy rights of all Americans, and I will continue to work closely with the Department of Homeland Security to ensure that privacy rights are protected fully during the implementation of PASS ID.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, as the national discussion over health care intensifies, one thing is already clear: Both Republicans and Democrats agree health care is in serious need of reform. The only thing that remains to be seen is what kind of reform we will deliver. Americans are increasingly worried about what they are hearing from Washington.

Americans want lower costs, and they want the freedom to choose their own doctors and their own care. What they do not want is a Washington takeover of health care along the lines of what we have already seen with banks, insurance companies, and the auto industry. Americans don't want a government-run system that puts bureaucrats between patients and doctors. They certainly don't want the kind of government boards that exist in places such as New Zealand and Great Britain that deny, delay, and ration treatments that are currently available to Americans.

Americans want change, but they do not want changes that will make existing programs worse. That is exactly what a government-run system would do.

Unfortunately, the notion of a government-run plan has been gaining steam. Over the past couple weeks, one Democratic leader after another has insisted that it be included as a part of any reform. The reaction to this should tell us something.

Among those who have begun to mobilize in opposition to America's plans are America's doctors who warn it would limit access to care and could lead to nearly 70 percent of Americans being kicked off the health plans they currently have.

The U.S. Chamber of Commerce, which represents about 3 million businesses in this country, has warned that the creation of a government plan would lead to a government-run health care system. The CEO of the renowned Mayo Clinic warned that some of the best providers could go out of business. The National Federation of Independent Businesses, one of the Nation's leading associations of small businesses, has also expressed its concerns about a government-run plan.

Americans don't want the kind of government-run system that some in Washington have proposed. They do not want politicians to use the real problems we have in our health care system as an excuse to tear down the whole thing, take away everything that is good about it, and replace it with something worse. They want practical solutions to specific problems, and that is what the rest of us are proposing.

Here are some commonsense proposals: We all agree health care in this country is too expensive. Americans don't think basic procedures should break the bank, and American families shouldn't have to worry about going bankrupt if a family member becomes ill.

But government-run health care will only make matters worse. If our experience with Medicare shows us anything, it is that the government health plans are not--I repeat are not--cost effective.

Over the weekend, the administration proposed making cuts to Medicare as a way of defraying the cost of a new government plan. That is exactly the wrong approach. America's seniors expect Congress to stabilize Medicare so it continues to serve their needs, not drain its resources to pay for another, even bigger government plan. Changes to Medicare should be used to make Medicare solvent for seniors today and for those who are paying into it and who will rely on the system tomorrow, not to build a brandnew government plan on top of one that is already on an unsustainable course. If we want to cut costs and rein in debt, then extending a Medicare-like system to everyone in America is exactly the wrong prescription. We need to make Medicare itself solvent and find ways to improve the current health care system.

One way to do that is to implement reforms that we know will save money. We could start with illness prevention programs that encourage people to quit smoking and to control their weight. It is no mystery that smoking and obesity are leading causes of the kinds of chronic diseases that are driving up health care costs. And finding ways to reduce these illnesses would also reduce costs. We should allow employers to create incentives for workers to adopt healthier lifestyles.

We should also encourage the same kind of robust competition in the health insurance market that has worked so well in the Medicare prescription drug benefit, Part D. We can enact long-overdue reforms to our Nation's medical liability laws. For too long, the threat of frivolous lawsuits has caused insurance premiums for doctors to skyrocket. Doctors then pass these higher costs on to patients, driving up the cost of care. Well, most people think health care dollars ought to be spent on health care, not insurance premiums. Yet doctors all across America are not only passing along the costs of higher and higher premiums, they are also ordering expensive and unnecessary tests and procedures to protect themselves against lawsuits.

One study suggests that roughly 9 out of 10 U.S. doctors in high-risk specialties practice some form of defensive medicine such as this--and the cost to patients is massive. Some doctors simply shut their practices or discontinue services as a result of these pressures. Patients such as Rashelle Perryman of Crittenden County Hospital are the ones who lose out. Rashelle's first two babies were born in Crittenden County Hospital, about 10 minutes from her home. But her third child had to be delivered about 40 miles away because rising malpractice rates caused doctors at Crittenden County Hospital to stop delivering babies altogether.

This isn't an isolated problem, and it is not just obstetricians. According to a report by the Kentucky Institute of Medicine, Kentucky is nearly 2,300 doctors short of the national average--a shortage that could be reduced, in part, by reforming medical malpractice laws.

Comprehensive health care reforms are long overdue--reforms that lower cost and increase access to care. But a government-run plan isn't the way to do it. There are other solutions that address our problems without undermining our strengths.

Over the past few weeks, I have warned about the dangers of government-run health care by pointing to the problems this kind of government-run system has created in places such as Britain, Canada, and New Zealand. These countries are living proof that when the government is in charge, health care is denied, delayed, and rationed. As I have noted, the main culprits in every case are the government boards that decide what procedures and medicines patients can and cannot have.

I have discussed how Britain's government board has denied care to cancer patients because the treatments were too expensive. In one case, bureaucrats in Britain refused to prescribe cancer drugs that were proven to extend the lives of patients because they cost too much. The government board explained it this way:

Although these treatments are clinically effective,

regrettably the cost . . . is such that they are not a cost

effective use of . . . resources.

I have also discussed how the government-run health care system in Canada

routinely delays care. Today, the average wait for a hip replacement at one hospital in Kingston, Ontario, is about 196 days. Knee replacement surgery at the same hospital takes an average of 340 days. The American people don't want to be told they have to wait 6 months for a hip replacement or a year for a knee replacement, but that is what could very well happen in a government-run health care system.

Finally, I have discussed how New Zealand's government board has rationed care by deciding which new hospital medicines are cost effective. In one case, government bureaucrats in that country denied patients access to a drug that was proven to be effective in fighting breast cancer because they thought it was too expensive. As one cancer doctor in the country put it:

New Zealand is a good tourist destination, but options for

cancer treatment are not so attractive there right now.

Americans want health care reform, but they don't want the kind of reform that denies, delays, and rations care, such as the government- run systems in New Zealand, Britain, and Canada. They don't want to be forced into a government plan that replaces the freedoms and choices they now enjoy with bureaucratic hassles, hours spent on hold, and politicians in Washington telling them how much care and what kind of care they can have. They want health care decisions left to doctors and patients, not remote bureaucrats. But if some in Washington get their way and enact a government takeover of health care, that is exactly what Americans can expect.

I suggest the absence of a quorum.

Mr. President, I rise today to introduce the Medical Efficiency and Delivery Improvement of Care Act, MEDIC, a bill which provides common-sense solutions to many of the most critical problems besetting our health care system. As we embark on reforming health care in America, we are faced with restructuring a system as complex as it is important--a system which includes not only doctors and patients but medical schools, nursing homes, hospitals and community health centers. While every piece of the health care puzzle requires individual attention, one common thread connects them all: the need for improved efficiency among providers though increased access to primary care physicians. They are the ones who can provide coordinated care for patients, leading to better quality and a more efficient system. That is why I am introducing this bill as a vehicle for proposals which increase the efficiency and coordination across the health care spectrum to improve health and save money.

In my State of Washington doctors and hospitals provide some of the a highest quality and most cost-efficient care in the nation. However, instead of rewarding our State for reining in unnecessary costs and improving the health of patients, the current system actually penalizes them. Under the current fee-for-service structure we have today, health care providers are rewarded for maximizing the number of services they provide rather than focusing primarily on health outcomes. This provides a financial disincentive to efficient care because such efficiencies actually result in decreased payments. My bill addresses this issue by linking physician payments to the quality of care they provide, not the amount of services they perform. At the same time, the bill recognizes the need to allow for the differences in the cost of doing business across different regions. The resulting policy creates a fair payment system that increases the overall quality of care while resulting in a savings of $55 billion a year off the Medicare rolls.

The backbone of our health care system is comprised of the men and women who devote their lives to the practice of medicine. While our nation's physician workforce is the best in the world, current policies have left our primary care network woefully lacking, leaving many families--especially those in rural areas--without access to basic care. As few as 2 percent of medical students opt for careers in family medicine and general surgery primarily due to the low pay associated with such specialties. Therefore, a fundamental goal of reform must be expanding the primary care workforce. My legislation includes provisions which provide financial incentives for medical students and teaching hospitals--such as interest-free loans and scholarships for students going into primary care, and increased funding for small and rural hospitals to improve their primary care residency programs. The bill also calls for increasing payments to primary care physicians currently in practice. These policies will result in an improved primary care infrastructure throughout the nation, providing for quality primary care today and well into the future.

Finally, we cannot address health care reform without addressing the needs the individuals who require it the most: those in long-term care. For many older Americans and people with disabilities, long-term care is not a luxury but a necessity, a required service needed to maintain their overall quality of life. Traditionally this care has been provided in institutions such as nursing homes, which can cost upwards of $70,000 a year. While some people require the around-the-clock care provided in nursing homes, many of those in need of long-term care would be better off remaining in their homes where they can continue to be active members of the community. Home- and community-based services provide people the care they need in non-institutional settings, which, in addition to saving a significant amount of money, allows for the freedom and independence to which people are accustomed. This legislation contains several provisions which provide States with the resources they need to move away from institutional long-term care and towards home- and community-based

services, such as increasing Federal Medicaid dollars to transition to home- and community-based services, and providing incentives to create consolidated information centers so consumers and their families can make well-informed decisions about long-term care options. If we gave just 5 percent of those who go into nursing homes the ability to receive care in their own homes and communities, the Federal Government would see a net savings of more than $10 billion over 5 years. This significant savings can be achieved while simultaneously providing better care; a truly win-win situation.

In introducing this bill I am reminding my colleagues that reforming health care need not be a zero-sum game. We can achieve our goals of improving the health care workforce, stabilizing the physician payment structure, improving access to needed care and decreasing the financial and emotional burdens associated with long-term care while simultaneously providing significant savings throughout the health care system. I look forward to working with my colleagues in the Senate to ensure these crtical reforms are enacted.

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.