Bill Frist

Mr. FRIST

Mr. FRIST. I thank the Senator from Kentucky. He is exactly right. We have people moving from a yellow State, such as Kentucky, to a white State. The white means States that are currently OK. You see California. I will come back to California and comment on that. We have people from Mississippi, that already has fewer physicians, moving up to Tennessee. And who knows, they may end up moving to Wisconsin or Indiana or out to California for the same reason. What is important, in response to the Senator from Kentucky's question, is that physicians are making decisions not on places they either like to practice to deliver the care they are trained to do, but now they are making decisions because of this exorbitant, runaway train. It is almost like a litigation lottery, malpractice lawsuit premiums that they are having to pay. They tell you that. That is the reason they are moving. So we have the cost issue. We have the specialty issue. We have physicians changing specialties, not because of their individual practice, what kind of care they are giving, but because the premiums are that higher for obstetricians versus gynecologists. Obstetricians deliver the baby; the gynecologists takes care of many other women's issues. Then you have the geographic movement to other States. There is a reason for all of this. It is a litigation problem. We need to fix the problem, and it can be fixed. The numbers are staggering. Between 1995 and the year 2000, the average injury award jumped over a 5-year period more than 70 percent to $3.5 million. That is the average. More than half of all injury awards today top $1 million of all the awards. The payouts aren't the only problem. Simply defending a malpractice claim, whatever the claim is, is more than $20,000, whether or not the doctor is at fault or the hospital is at fault. So there is an incentive through these exorbitant contingency fees where the trial lawyers, the personal injury lawyers, may make 40 percent. If there is a jury award, the trial lawyer, the personal injury lawyer gets 40 percent of the cut. Thus the personal injury lawyer has the incentive, the economic incentive to go out and engage in lawsuits, in frivolous lawsuits. Each one of those which comes forward, no matter what, just to defend costs at least $20,000. In 2001, physicians in many States saw their liability premiums for these frivolous lawsuits, excessive lawsuits that go to the millions and millions of dollars, with the trial lawyers taking off 40 percent--and Senator McConnell's amendment addresses this contingency fee very directly to put some sort of control on the incentive that trial lawyers have to dig up these cases, then the physicians, because of the tremendous cost, whether the case is frivolous or not, they tell their insurance company to settle the case. They don't want to be tied up in a court. They want to deliver care. That is what physicians are trained to do. That is what they are obligated to do. The solution: Intelligent, reasonable tort reform, sensible reform with fair and equitable compensation for those negligently injured. California has addressed this. Hopefully, over the next several days or hours we will address their experience. We have seen California put very reasonable controls and caps and incentives addressing things broadly, and they have been able to control their costs. So we know it can be done. I see my time is about over. I look forward to coming back Monday to talk a little bit more about this issue. The bottom line is, the McConnell amendment will help patients. That is what it is about. Patients are suffering today. We know sensible tort reform works. We have seen it in California, in those States that have been progressive enough to do that. Now we have a duty to make sure these red States become yellow States and eventually become white States where we don't have this crisis today. Sensible tort reform works. Let's act now to protect patients, their accessibility to quality care, the premiums that physicians have to pay which are ultimately translated down to cost to that individual patient. I urge support of the underlying amendment.

Mr. FRIST. Mr. President, how much time is remaining on our side?

Mr. FRIST. And the other side?

Mr. FRIST. I am happy to yield.

Mr. FRIST. Mr. President, I mentioned in comments a few minutes ago the fact that I was in the hospital yesterday and two nights ago with a family member and I will go there in a few minutes. Being there as a patient's family is a different perspective than being there as a physician or Senator. As one walks those halls and sees people working hard, day in and day out, 24 hours a day, as one watches the shift change at 7 or 8 at night, fresh people coming in and starting, and see physicians coming in at 9, 10 at night, starting early in the morning, seeing the emergency room and trauma centers going on around-the-clock, when one sees that and recognizes that we can do something that will make that better when the trends, especially in the last 3 to 4 years, are getting worse, it makes one feel very passionately about that. When I see doctors leaving the practice of medicine for this reason, these exorbitant, skyrocketing, out of control--this runaway train which I mentioned earlier, such good imagery--it makes me want to passionately come to this body and make sure that people understand, make sure that my colleagues understand, that physicians are leaving the practice of medicine because of these exorbitant malpractice suits. A physician who gets up every morning to take care of patients who come through that door is being charged $100,000 not for what they do but to cover the legal system and these out-of-control malpractice suits, which I will say are in many cases driven by the trial lawyers, there is no question in my mind, and if you talk to people broadly they will say lawyers have the incentive. When one sees that happening and sees that patients are going to suffer, they want to act. That is what this McConnell amendment allows us to do, to do something that does not solve the problem; it does not go as far as I want to go. As the Senator from Kentucky said, does not go so far as the American Medical Association, which represents so many tens of thousands of doctors, would go, but it is a first step. It puts the issue back on the table, and we ought to talk about this issue in this body. It has been 7 years since we have actually addressed this issue, an issue that patients are being hurt by, that is driving physicians out of the practice of medicine, that is driving physicians from Kentucky to Indiana, from Mississippi to Tennessee, out of New York City, out of New York, out of Texas, out of Florida, that is driving the price of health care up unnecessarily. It is unnecessary. In fact, it is hurting patients unnecessarily; it is not helping patients. If there is malpractice, there needs to be appropriate punishment. There needs to be appropriate economic compensation. It needs to be fair. It needs to be equitable. But these skyrocketing lawsuits, many of them frivolous, need to be brought under some sort of moderation and some sort of control. I mentioned that Dr. Wasserman, who is chairman of the Department of Medicine at George Washington University, who is in the hospital working right now--we did not even really talk about this specifically in any detail, but in the newsletter that I quoted earlier, which is pretty good reflection of what is going on in every hospital around the country, it is important for my colleagues to know that sentiment. In that same newsletter, I read one sentence earlier saying that what we are facing, in terms of this lack of tort reform, a medical liability crisis being a runaway train, a beautiful analogy. He said, and I quote from the second paragraph of the letter: Malpractice rates are increasing at a rapid rate across this nation. Insurance companies are going out of business, refusing to write new policies, or raising rates 50 to 200 percent. People say, why? Some say it is the bad insurance companies that are making profits and taking advantage of people broadly, and that is where the problem is. Well, I disagree. It may be part of the problem that may need to be addressed, but the fundamental problem is the frivolous lawsuits, with no sort of restraint, with out-of-control incentives for the personal injury lawyers to take a 40 percent cut, to increase the number of cases, to bring these suits, again with no limits, no caps, not a $100,000 cap, a $500,000 cap, a $1 million cap, $5 million cap or $10 million--it does not matter what it is, they take away 40 percent of whatever it is so they are going to drive it high. The McConnell amendment stops short of what I would really like to do, and it does not have any sort of limitation of payments. It looks at limits on attorney's fees, establishes proportional liability, looks at both scopes, such as collateral service reform, which we will be able to talk about, but it is a good first step. Dr. Wasserman, in his newsletter--and this will be the last time I will quote from it, but it captures it--says: Be patient. There is a coming crisis. Already, there is a shortage of physicians in certain medical specialties in certain areas. Do not try to have a baby in Las Vegas. There are no obstetricians. Try to find a rheumatologist in Florida in the winter with less than a 3-month wait. At some point, this will be politically important when more people are denied immediate access to health care, and then maybe change will come. That hurts me in many ways, because it basically says we do not have the guts to face an issue that is not just dollars and cents and profits and all of this class warfare that we hear about, but an issue that is hurting patients, where the patients suffer. The example is right before our eyes, and I do not see how we cannot address it. The example I mentioned earlier in the great State of Nevada, where physicians actually had to close down a trauma center, a level-1 trauma center, which is sophisticated care that can be delivered adequately in no other way, and if you are in that automobile accident, your care is in jeopardy. It does not have to be this way if we can pass this amendment, continue the discussion, again, hopefully improve and strengthen this amendment in the future. This is not going to go away. It is getting worse. It is getting worse before our eyes. We last talked about it on this floor 7 years ago. This is the first time since then. That is inexcusable. I mentioned the level 1 trauma center having to close, leaving patients for that period of time if they were in an accident having to go an additional hour and a half for proper care. Let's look at the obstetricians and gynecologists. Again, as I mentioned earlier, an obstetrician/gynecologist is trained to do gynecology, women's health issues. An obstetrician's practice is to deliver babies. It is a good example because as these doctors' insurance premiums go sky high, and when they go sky high, the obstetricians are saying: I cannot deliver babies anymore. I am going to change to the field of gynecology. Then the mom, who has been going to that obstetrician for 5 years, 10 years or 15 years, goes to see their physician who says: I am not delivering babies anymore, and the reason I am not is because I cannot afford that malpractice insurance. So then all of a sudden there is this problem with access to care affecting the individual. We talked a little bit about costs; we talked about physicians moving. I again ask women all over this country to ask their obstetrician what is happening to obstetrics care today because of malpractice insurance. Nationwide, 1 out of 10 OB/GYNs no longer deliver babies because of this high cost of liability insurance. Obstetricians are not just geographically moving but are leaving the practice altogether. Again, I can say that. I can go to a hospital and say that. I can say that as a Senator and as a physician. The best thing is for people to talk to their obstetricians and ask how this malpractice insurance impacts on them. Earlier today we heard some comments about insurance companies, and I think on Tuesday we will have the opportunity to come back to that as well. Much of my focus is on the individual patient and on the impact on the practice of medicine, which is very real. I do want to at least introduce the fact that these insurance companies, many of which are not-for-profit in the sense that they are mutual funds--and I will use the example of the State Volunteer Mutual Insurance Company in Tennessee. It is owned by the physicians in Tennessee. Again, it is not a red State yet. It is on the verge of being a crisis State. Eighty percent of the physicians in Tennessee come together and have a mutual insurance company because they can have the input and they can try to keep the rates down in the very best way possible. I will read from a letter, and I ask unanimous consent to have this printed in the Record, dated July 25, from the State Volunteer Mutual Insurance Company.

Mr. FRIST. The State Volunteer Mutual Insurance Company is a policyholder owned mutual company with no outside investors. So I think they don't have a huge incentive to go out and gouge the communities or patients. It is mutually owned by physicians throughout the State. In the letter to me, I read further: Senator Frist, doctors and hospitals in Tennessee are dedicated to providing excellent care to our state's population. But at a time when health care reimbursements are shrinking, and professional liability costs are dramatically increasing, doctors in Tennessee believe that Congress should enact some common sense tort reform that will preserve citizens' access to health care and compensate them for their actual economic damages caused by negligence, while modifying the current system of unlimited liability that doctors and other health care professionals and institutions currently face. This letter was written by Steven C. Williams, president and CEO of the insurance company, but also representing 80 percent of the physicians in Tennessee, calling for sensible reform, for moderate reform, reform that does not go overboard. That is what the McConnell medical malpractice amendment indeed does. What is most important is what is happening to patients. Patients are suffering under the current system. It is a runaway train. We all know it is a problem. We have seen it in Las Vegas at the trauma center. We see it in various States. We go in our physician's offices and hear it. The problem is getting worse. It is increasing in its impact and not getting better. That is why we call for action now. The Tennessee Medical Association, in a letter dated July 24, 2002, to me: We have a storm brewing here in Tennessee. While the waves are not yet crashing in on us, as in many states, including our next-door-neighbor, Mississippi, it most certainly is coming. Over the last two years, medical malpractice insurance rates have gone up 32 percent. Of additional concern is that in Tennessee there is a very clear trend of increasing awards in medical malpractice cases. This, we believe, is fueled in large part by a growing public perception and environment that likens the courtroom to a casino where there appears to be no limit. That was Michael A. McAdoo, president, Tennessee Medical Association. The medical liability premiums are skyrocketing. It is because the medical liability claims are exploding. It is because the awards are exploding. The problem is not limited to just the Northeast or the Southeast. But as you can see from this map, the medical liability crisis is all over the United States of America. It has to do with cost and access to care and physicians leaving their profession. The response to what we do means we have to identify the underlying problem and not just worry around the edges or tinker around the edges. I mentioned earlier, an average jury award over a 5-year period jumped more than 70 percent on average. When more than half of all jury awards top $1 million, we have this field of defensive medicine. That means physicians in the emergency room that I was in two nights ago, attending to a patient, are going to err in going a little bit too far in terms of tests. Why? Because if that headache, which to your exam is just a routine frontal headache treatable by a doctor, if you do not get the CAT scan or MRI scan, the risk, although it is beyond the normal bounds of routine accepted medical practice, a physician, a nurse, or a hospital is going to err on getting the expensive tests, although in your clinical judgment and using the practiced guidelines out there today, you do not need the tests. But you will get that series of more expensive tests that unnecessary testing. Again, the American people pay for it. Those costs are unnecessary. They are there because of the fear of skyrocketing lawsuits, numbers of lawsuits, awards themselves. No one wants to be in that category. The best protection is to get the range of tests, although you may think they are unnecessary. What is the effect on the doctor? In 2001, physicians in many States saw their rates rise by 30 percent, and even more. That is just physicians, generally. If you look at the specialists, such as obstetricians or possibly neurosurgeons or neonatal specialists, malpractice insurance is rising by as much as 200 percent, and in some cases 300 percent. In New York and in Florida, obstetricians--the ones who deliver babies--gynecologists, and surgeons pay more than $100,000 for $1 million in coverage. That $100,000 they pay comes out of their pocket initially, but for them to stay in business and continue what they do, they take that $100,000 and pass it on to the people who are listening to me, the people all across America. That is why this issue is so powerful today. People for the first time realize one doctor out there, who took an oath to do no harm, to help patients, who trained 4 years in medical school, a year in internship, 5 years in surgical residency, 2 years in specialty training, and a year of fellowship, just to be able to help people, are having to pay $100,000, not to help people, but to protect themselves. That is absurd. Ultimately, for them to stay in business it gets passed all the way back through the system to that individual patient. It may come in taxes. It may come for those who do not have insurance, and pay retail, who do not have any insurance when the overall prices in health care go up. If you do not have insurance, you are in trouble today because the overall price of health care has skyrocketed. This is an area where through commonsense tort reform we can lower this escalating cost of health care across the board. For annual premiums, some doctors in Florida and New York pay, again, above $100,000. That is one individual doctor. This is not a big corporation that pays this. It is not a big hospital paying it. These are individual doctors paying this money so they can fulfill that Hippocratic oath of doing no harm. In Tennessee, which is not yet in the crisis mode, and is not considered to be in crisis, but it has problem signs today, the premiums rose 17.3 percent last year in 1 year. They will rise anywhere from 15 percent to 17 percent this year. What we need to do is ask why. Is there more malpractice today? Are physicians not as well trained today as they were a year ago, or 5 years ago, or 10 years ago? Are they not using the tests appropriately today in order to take care of patients? If so, we need to debate that issue and look at it and look at the data that is out there. No, I think the dynamics are because of frivolous lawsuits, because the personal injury trial lawyers have a huge incentive, a huge financial incentive for themselves in order to bring cases forward, which puts physicians in a position where it is easier to settle these cases rather than to spend a year or 2 years, if you have the insurance. So there is this huge settlement, even if you don't have malpractice, even if you know that you are absolutely innocent. It is easier to settle for $1 million or $2 million so you can go back to the practice of medicine. The system is broken, and it is getting worse. Can it be fixed? Yes. The McConnell amendment makes a first step there--intelligent, reasonable, balanced tort reform. It will help address it, but it will not solve the entire problem. It is not going to make it go away, but I can tell you, it will help patients because they will not have to be driven to the ranks of the uninsured; because that obstetrician, with whom they have the first baby and second baby, will not have left practice because of that malpractice insurance; because they will be able to see the neurosurgeon for their brain tumor in their region because he or she did not move from Texas to Wisconsin because of these exorbitant malpractice rates. I mentioned earlier that today is different than 6 years ago when we last addressed it. It is in a lot of different ways because the problem is getting worse. Ask the physicians, ask the people in the hospitals who are working there every day. Read the newspaper, and you will see that every newspaper is going to address this in a direct way. I think we need to go back and look at hard data that is out there today, in terms of what certain States have done and been able to accomplish and what other States have tried, and learn from that. In California there is what is called MICRA, which is the Medical Injury and Compensation Reform Act. It became law in the mid-1970s. It is a good example of what works. When you look at States, other big States, you see a lot of them are in trouble. You see New York City is in trouble. If you are in New York City, talk to the physicians, talk to the medical community, ask them what has happened in terms of these tort issues recently. Look at Pennsylvania; it is in trouble. Look at Florida, look at Texas, where there is trouble. This is California in white, meaning they do not have a huge problem there. You do not hear it. I was in California this past weekend and probably talked to six or seven people in the medical profession at academic health care centers, and it is not No. 1 on their list for reform because they say it is not a big issue there. Why? In the 1970s, California passed MICRA--Medical Injury and Compensation Reform Act. California doctors and patients have been spared much of the medical liability crisis that we see across the country today. I think it is a good surrogate measure, that California's premium, the premiums they are paying today, are among the lowest medical malpractice insurance premiums in the country. MICRA is the reason. I have used this example of obstetricians and gynecologists, so I will keep going back to that. It is the reason that the obstetrician, the one who delivers babies in California, may pay about $40,000 for medical liability insurance where, if you took that same obstetrician-- same training, same medical school, had done the same number of procedures, delivered the same number of babies--and you put them in, let's say Florida or let's say New Jersey, or you put them in New York, the premiums--here, say, $40,000 for that insurance--it will be above $100,000, maybe up as high as $150,000. The same person, same training, same number of babies, same Hippocratic Oath--"Do no harm''--here paying around $40,000; in these red States, paying upwards to $150,000. My colleagues have to ask why, but more important, the American people have to ask why. Is there less malpractice in California? I don't think so. Better trained doctors in California? I don't think so. The reason goes back to the tort system, the liability system. In other States it has been allowed to run out of control, and that is why this McConnell amendment comes in. Again, we have not really talked about all the things that are in the amendment. We will have the opportunity to do that. But that is why it is important to go back and look at what is in the amendment. It doesn't go very far. It doesn't go far enough for me or, I think, for most of my colleagues in the medical profession. But why does MICRA work? Why does this doctor with the same training pay so much less than these other States? Let's look at MICRA. What does MICRA do? This is not the McConnell amendment. I don't want to confuse the two, but it shows what commonsense reform in a State that was way ahead of the curve can accomplish. MICRA does limit attorney's contingency fees to a sliding fee scale. This allows the patient, when there is an award, to keep the money. If it is malpractice and you are trying to compensate the patient, to have the lawyer walk away with 40 percent of the money doesn't make sense to me. I don't think it makes sense to the American people once they really understand that. With this limiting of how much the attorney can take out of what is sent home by the jury to the patient, by limiting that in some way, you have some element of control of this runaway train which is hurting patients. It is pretty simple. In my mind it is simple. If you look at how much a lot of these personal injury trial lawyers make today, especially in the environment where we are looking a lot more at the corporate world, the numbers are incredible. Ask, if you take the top 50 personal injury trial lawyers in America, what is their take? What do they make? The incentive is there. If you are in the field of law, you would like to say, I am out just to save the world and do good. But when you take 40 percent of the take after a multimillion malpractice injury--first of all, the patient doesn't get it. That is who it is really about--or that is who it is about in the medical profession. It needs to be about the patient. That is whom you take the oath to serve. It is hard for me to understand how you could have the huge contingency fees today when you hear physicians are leaving, they are not taking care of patients, they are being forced to close down trauma centers. MICRA places a statute of limitations on bringing a suit 1 year from discovery or 3 years. This is the California law. This ensures that a suit would be brought in a reasonable amount of time. It protects evidence, and it also keeps people from sort of searching in the bowels of a hospital or advertising for cases 5 years ago, or 20 years ago, or 30 years ago. Again, malpractice occurs at a certain point in time, and we need to punish it, and punish it hard. But to go out and stir up these cases so you can be paid for it, I think is inappropriate. What MICRA does--and again this is not in the McConnell legislation, and this I hope will come back to the floor again and again and again until we fix it--MICRA, California law, caps future noneconomic damages at $250,000. These are not the economic damages. There is full compensation there. So, under MICRA, patients are fully compensated for their economic loss due to medical malpractice, and they are compensated for lost wages, and they are compensated for the medical care and the future costs of medical care. I use California as an example because we have not talked about it on the floor of the Senate. We haven't talked about it in committee, because this whole issue has not been addressed. The bottom line is you can have reforms--which the majority of States do not have today, and that is the reason there is a role for this body to act--because the problem is well identified, and the problem is getting worse. The problem has not been adequately addressed by States--California and a handful of others have addressed it--so that we have an obligation to the patients. The reforms in California have helped the patients. Injured patients receive a larger share of whatever award. If there is malpractice and there is an award, the patient can walk--hopefully, can walk--home with more of that award. In addition, these reforms have helped slow down the overall rising cost of medicine. There is no question in my mind that physicians are practicing defensive medicine, which the physicians have to practice, and this drives up the overall cost of health care today. We talk a lot about prescription drugs, about the importance of generics, about the importance of coverage within Medicare, and about having a competitive system--all of which we hope will actually slow down the skyrocketing costs of medical care today. Indeed, the cost of health care in California has been slowed by the slowing and the restraining of these out-of-control, skyrocketing, runaway train costs in liability that other States have.

Mr. FRIST. I would be happy to yield.

Mr. FRIST. Probably 5 minutes, and then I would be happy to yield the floor. Madam President, how much time do we have on either side?

Mr. FRIST. Madam President, let me take a couple of minutes, and then I would be happy to sit down and look forward to the opportunity to talk about all of this on Tuesday, which I believe is when we will come back to this. The McConnell medical malpractice amendment does the following: It limits punitive damages. It limits punitive damages to two times the sum of what are called compensatory damages. Again, this gets sort of technical. We talk about economic damages and noneconomic damages. It allows punitive damages in those cases where the award has been proven by clear evidence and by convincing evidence. I mentioned attorney fees. I am critical of that because I don't understand in this day and time why personal injury trial lawyers walk away with so much money that has been awarded to the person who has been injured. But it does limit attorney fees. The McConnell amendment places very modest limits on attorney's contingency fees and medical malpractice cases. Specifically, the amendment allows personal injury lawyers to collect 33 percent, or a third, of a $150,000 award, and about $25 percent of the award on all amounts above $150,000. Again, that is pretty modest from my standpoint. The fact that an award to somebody who has been injured is $150,000, it was malpractice, and the fact that a trial lawyer will take away a third of that for their pocket, again, to me--that is what is in the amendment--that is an improvement over today. But, again, in the future I hope we come back and address that. The statute of limitations--I mentioned California's law--the amendment requires that a medical malpractice complaint must be filed within 2 years of discovering the injury and the cause. Again, that is when it should be filed. The McConnell amendment is modest. It identifies the problem. It gives us the opportunity to talk about the problem on both sides of the aisle. It does not include all of the measures I think are necessary to address this problem eventually. But it is a good first step in the right direction. We have evidence that reasonable tort reform--and we can debate what reasonable tort reform is. I think, again, the McConnell amendment is the first step. It doesn't go quite far enough, but it is a good first step. We know that by addressing this we are going to hold down health care costs which are skyrocketing. The premiums are going up 15 percent, 17 percent, and 20 percent--last year, this year and next year. That translates down to the patient. Those premiums are eventually going to be passed down to the patient. To my mind, there is no question but that we will put them in the ranks of the uninsured. On the access issue, the McConnell amendment is a simple amendment. I am convinced. Ask your physician, if you have the opportunity over the weekend. I am absolutely convinced it will improve access when we know that access overall is deteriorating. We need to look at Las Vegas, and we need to look at the many examples which are in newspapers all across the country of physicians leaving a specialty practice because of malpractice insurance, or leaving a State. We have an opportunity to do something which protects patients and which improves their access and clearly stops the deteriorating access to quality care before this problem gets worse. I urge support of this amendment and look forward to coming back to it over the next several days. I reserve the remainder of my time.

Mr. FRIST. Mr. President, I want to change the topic and focus where I believe the impact is most being felt today. It really has not been discussed on the floor thus far; and that is, at the level of the doctor-patient relationship, at the level where care is actually delivered. We heard a lot about the budget numbers and the insurance companies and the like, but what I would like to do is focus on where the impact actually is. Yesterday, I was at a hospital, not as a physician, but I was there with someone in my family. I was in an emergency room 2 nights ago and then yesterday. Again, I was not there as a doctor or as a U.S. Senator. It was a local hospital, George Washington University Hospital. On a side table, I picked up a newsletter. Again, it was not intended for me. The newsletter is called the ``GW Medicine Notes.'' I have it in my hand. It is written by their medical staff for their medical staff and, I guess, for people in the hospital. The letter is from the chairman, Dr. Alan G. Wasserman. The whole front page really tells the story that much of the debate will be about today and on Tuesday. I will open with just one sentence or two sentences from this letter, again not intended for me, but to really express the sentiment, the impact of what is happening all across America because what we are seeing today is, indeed, a crisis. The words, again, from Dr. Wasserman, in what is called the ``GW Medicine Notes,'' a monthly publication of GW, the George Washington Department of Medicine: What we have is a runaway train that isn't stopping. The malpractice problem is not just a physician problem. It is beginning to affect the ability of patients to get proper care in a timely manner. I may refer back to this letter because I found it fascinating, sitting there yesterday waiting for an MRI scan, just to see the sentiment that patients are actually being hurt. When I saw the words: ``What we have is a runaway train that isn't stopping,'' the imagery, I think, is very appropriate. We cannot do little things. This train is barreling through, and patients are being hurt. Forget all the rhetoric, the dollars and cents, the bad insurance companies and the profits. Patients are being hurt by the current tort system that we have in effect today. The good news is, there is something we can do about it, and it starts right here with the McConnell amendment that is on the floor today. I want my colleagues to listen very carefully. I hope, in the expanded reach, people are listening, because we have an opportunity, in this amendment, to improve patient care, and to reverse this runaway train, which is hurting patients today. How can I say so definitively that patients are being hurt? You can look in the media. You can go into hospitals. I encourage everybody to ask their doctor. The next time you see your doctor or see a nurse or go into a hospital or interact with your health care system, just ask: What are these malpractice premiums doing? We will talk a little bit about why premiums are going up. What is being said around the country? Pick up the newspaper any day all across the country. Allentown, PA; Beckley, WV; New York, NY; Kansas City, KS; Jackson, MS. Jackson, MS, November 23, 2001: Costs Lead Rural Doctors to Drop Obstetrics. That is because of the cost of the malpractice insurance. OB/GYNs are refusing to deliver babies and are dropping obstetrics. Allentown, PA: CARE CRISIS: Malpractice premiums crippling doctors. The emergency has stricken physicians in southeastern Pennsylvania, forcing some to leave their practices and patients behind. Beckley, WV: The situation may be more acute in West Virginia than anyplace else, but doctors across the board and around the country are facing double-digit hikes in malpractice premiums, something many hadn't seen since the 1980s. Kansas City, KA: Insurance rates reach crisis level for doctors. Some physicians have been forced to leave practices. Again, we are talking about access to health care and costs of health care. Dayton, OH: WOMEN'S HEALTH CARE CRISIS LOOMS. . . . Rising malpractice premiums may force some doctors to stop delivering babies. Buffalo, NY: Soaring costs of medical malpractice insurance have caused fears among doctors that they will be forced to either quit their profession or practice in another state. We all recognize this problem. I think both sides are going to state, again and again, that medical liability insurance premiums are skyrocketing. Why? The facts are there. We know it. We see it. Our physicians tell us why. We can look at what our insurance companies are having to charge today. The question is, why? Medical liability claims and damage awards are exploding, and when they explode, that ends up being translated into increased premiums. People think those increased premiums are paid for by the doctor. When the doctor pays $50,000 or $100,000 in malpractice insurance, it is not really paid by the doctor, because the doctor is going to pass that straight back to the patients. When you go to a doctor for a particular procedure part of that procedure is going just to buy the insurance. These costs ultimately increase premiums. First of all, increased jury awards increase premiums. They are eventually passed back to the patient. We saw a chart earlier today. Let me just show it again. It is not just in George Washington Hospital, where I happened to find this newsletter and talked to the doctors and nurses there, and not just at Vanderbilt but all throughout the local and national medical community. The problem is all over the United States of America. This is from the AMA. Basically, it outlines, in red, those States that are in crisis. You can see, it is not just on the east coast, and it is not just in the South, and it is not just in the Northwest. Shown in red are States in crisis: New York, Pennsylvania, Texas, Nevada, and Washington. Shown in yellow, including my home State, are States with problem signs. As these rates increase 15, 16, 17 percent, sometimes 20 percent, sometimes 30 percent, they will force more states into the red, unless we act. The end product of all this, all those articles, the end product of the newsletter--this is what is circulating in hospitals and clinics all over the United States of America--is that patients are suffering. Why do I say that? No. 1, access to care. It is not just a matter of the costs, but it is access to care. If you are in a motor vehicle accident and you need a trauma center, we have seen trauma centers close because of these escalating, out-of-sight, skyrocketing premiums, which no longer can be tolerated. If you are one of those individuals who needs that care, the access is not there, and you are going to be hurt. If you need an obstetrician--in many ways, it is a woman's issue--and your former gynecologist-obstetrician is one who gave up that interest in delivering babies because the malpractice insurance was so high, your access to obstetrics care, the delivery of babies, and the prenatal and perinatal care all of a sudden disappears. Why? Ask your obstetrician. It is because the malpractice insurance has gone sky-high, from $10,000, $20,000, $30,000, $50,000, $100,000 up to $150,000, and it can no longer be sustained over time. So physicians are dropping services. They have no choice. They are moving away from procedures that have a higher challenge rate because of the risk of the procedures. But if you are one who needs that procedure, you suffer from a lack of access to care. Those procedures that are a little bit higher risk, physicians are beginning to leave and not do them. We have had letters read about malpractice insurance. All of us understand that malpractice insurance needs to be addressed. It is the only way to improve the system itself. Malpractice does occur. There is nothing in the McConnell amendment that in any way lowers the standards on malpractice. You will have the other side reading a whole series of letters from people who have been injured. And as the Senator from Kentucky pointed out, there is nothing in his amendment that lowers the standards in any way in addressing true malpractice. My colleagues who are physicians are now demanding action by Congress. Why? Because they took that Hippocratic oath to take care of patients, to do no harm. To illustrate this runaway train concept that Dr. Wasserman mentioned in his newsletter, things are at a crisis, we have level 1 trauma centers closing. Thank goodness they are not closing permanently but closing for this very reason--not for a whole broad range of reasons of cost increases but for this very reason--the high costs of liability insurance. A level 1 trauma center is a big deal. It is not just an emergency room, and emergency rooms are terribly important, but it is not just an emergency room that sutures cuts or takes care of serious headaches. This is where you go if you are in a severe motor vehicle accident, have severe head trauma, multiple injuries, bleeding in the abdomen. This is where you go where you have trained specialists 24 hours a day to save your life. That is what a level 1 trauma center is. The only level 1 trauma center facility at the University of Nevada Medical Center closed on July 3 after 57 orthopedic surgeons basically resigned because medical malpractice insurance rates made it too costly for them to treat high-risk patients. Luckily, fortunately, the trauma center reopened when the surgeons agreed to return for at least 45 days. People can look at that case and say it was for this reason or that. The bottom line is, we have a group of people in a community who took an oath to take care of patients, but basically said this is such a severe, fast-moving, heavy, runaway train that we can't sustain what we do professionally because of this crisis. This particular trauma center is one of the 10 busiest in the country and is the only one in Las Vegas. When it closed, the nearest trauma center was roughly an hour and 20 minutes away. Therefore, when we talk dollars and cents and insurance companies making money, we need to address all of that. But let's recognize that we have to fix the system which has now gotten so bad, so severe that premiums are skyrocketing. That increase is passed on to patients. Patients cannot afford increases in health care costs. We have known that for a long time. Now what is happening, the actual care expected by the American people and that the American people deserve is less available. We call it less access. But whether it is a trauma center closing, whether it is a woman who wants to keep her obstetrician, but the obstetrician says he can't afford to keep delivering babies because of these premiums, because of these excessive lawsuits, these frivolous lawsuits today, he can't afford his old specialty that he was trained to do. Then there is the third component of access. You have physicians leaving parts of the country. Basically, some parts of the country, these red areas where you have this crisis level, malpractice insurance has gotten so high that a physician can either quit--and they are doing that; they have no choice. Ask your physicians.

Mr. FRIST

Mr. FRIST. Mr. President, I spent the first 20 years of my career studying and working in medicine. I graduated from medical school in 1978. After that, I trained as a surgical resident for eight years. I then worked as a heart and lung transplant surgeon until I was elected to the United States Senate in 1994. During that time, HIV/AIDS went from a disease without a name to a global pandemic claiming nearly 20 million people infected. It's hard to imagine an organism that cannot survive outside the human body can take such an immense toll on human life. But HIV/AIDS has done just that--already killing thirteen million people. Today more than 40 million people--including three million children--are infected with HIV/AIDS. HIV/AIDS is a plague of biblical proportions. And it has only begun to wreak its destruction upon humanity. Though one person dies from AIDS every ten seconds, two people are infected with HIV in that same period of time. If we continue to fight HIV/AIDS in the future as we have in the past, it will kill 68 million people in the 45 most affected countries between 2000 and 2020. We are losing the battle against this disease There is neither a cure nor a vaccine for HIV/AIDS. But we do have reliable and inexpensive means to test for it. Also, because we know how the disease is spread, we know how to prevent it from being spread. We even have treatments that can suppress the virus to almost undetectable levels and significantly reduce the risk of mothers infected with HIV/AIDS from passing the disease to their children. We have many tools at our disposal to fight the spread of HIV/AIDS. But are we using those tools as effectively as possible? The gloomy statistics prove overwhelming that we are not. What we must do is focus on what is truly needed and what is proven to work and marshal resources towards those solutions. We have beaten deadly diseases on a global scale before; we can win the battle against HIV/AIDS too. More than 70 percent of people infected with HIV/AIDS worldwide live in Sub-Saharan Africa. But the devastation of the disease--and its potential to devastate in the future--is by no means limited to Africa. HIV/AIDS is global and lapping against the shores of even the most advanced and developed nations in the world. Asia and the Pacific are home to 6.6 million people infected with HIV/AIDS--including 1 million of the five million people infected last year. Infections are rising sharply--especially among the young and injecting drug users--in Russia and other Eastern European countries. And the Americas are not immune. Six percent of adults in Haiti and four percent of adults in the Bahamas are infected with HIV/AIDS. I believe the United States must lead the global community in the battle against HIV/AIDS. As Sir Elton John said in testimony before a committee on which I serve in the United States Senate, ``What America has done for its people has made America strong. What America has done for others has made America great.'' Perhaps in no better way can the United States show its greatness in the 21st century--and show its true selflessness to other nations--than leading a victorious effort to halt the spread of HIV/AIDS. But solving a global problem requires global leadership. International organizations, national governments, faith-based organizations and the private sector must coordinate with each other and work together toward common goals. And, most importantly, we must make communities the focus of our efforts. Though global leadership must come from places like Washington, New York and Brussels, resources must be directed to where they are needed the most--to the men and women in the villages and clinics and schools fighting HIV/AIDS on the front lines. Adequate funding is and will remain crucial to winning the battle against HIV/AIDS. But just as crucial as the amount of funding is how it is spent. Should we spend on programs that prevent or lower the rate of infection? Should we spend on treatments that may prolong the life of those who are already infected? Should we spend on the research and development of a vaccine? The answer is yes . . . to all three questions. We can only win the battle against HIV/AIDS with a balanced approach of prevention, care and treatment, and the research and development of an effective vaccine. HIV/AIDS has already infected tens of millions of people and will infect tens of millions more. We need to support proven strategies that will slow the spread of the virus and offer those already infected with the opportunity to live as normal lives as possible. And if our goal is to eradicate HIV/AIDS--and I believe that is an eminently achievable goal--then we must develop a highly effective vaccine. But even with proven education programs or free access to anti- retroviral drugs or a vaccine that is 80 to 90 percent effective, our ability to slow the spread of HIV/AIDS and treat those already infected would be hampered. The infrastructure to battle HIV/AIDS in the most affected areas is limited at best. We need to train healthcare workers, help build adequate health facilities, and distribute basic lab and computer equipment to make significant and sustainable progress over the long-term. To win the battle against HIV/AIDS, we must not only fight the disease itself, but also underlying conditions that contribute to its spread--poverty, starvation, civil unrest, limited access to healthcare, meager education systems and reemerging infectious diseases. Stronger societies, stronger economies and stronger democracies will facilitate a stronger response to HIV/AIDS and ensure a higher quality of life in the nations most affected by and most vulnerable to the disease and its continued spread. And we can make significant progress without vast sums of money and burgeoning new programs. Take, for example, providing something as basic and essential as access to clean water. 300 million or 45 percent of people in Sub-Saharan Africa don't have access to clean water. And those who are fortunate enough to have access sometimes spend hours walking to and from a well or spring. It costs only $1,000 to build a ``spring box'' that provides access to natural springs and protects against animal waste run-off and other elements that may cause or spread disease. 85 percent of the 10 million people who live in Uganda don't have access to a nearby supply of clean water. It would cost only $25 million to build enough ``spring boxes'' to provide most of the people living in rural Uganda with nearby access to clean water. Providing access to clean water is just one of the many ways in which the global community can empower the people most affected by and most vulnerable to HIV/AIDS. In some cases, such efforts--like supporting democracy and encouraging free markets--may cost little or take a long time, but they will make a significant difference in the battle against HIV/AIDS and the quality of life of billions of people throughout the world. We have defeated infectious diseases before--sometimes on an even larger scale. Smallpox, for example, killed 300 million people in the 20th century. And as late as the 1950's, it afflicted up to 50 million people per year. But by 1979 smallpox was officially eradicated thanks to an aggressive and concerted global effort. What if we had not launched that effort in 1967? What if we had waited another 35 years? Smallpox likely would have infected 350 million and killed 40 million more people. That is a hefty price for inaction--a price that we should be grateful we did not pay then, and we should not want to pay now. Right now we are losing the battle against HIV/AIDS. But that doesn't mean we can't win it in the end. Indeed, I believe we will ultimately eradicate HIV/AIDS. We have the tools to slow the spread of the disease and provide treatment to those already infected. And we have the scientific knowledge to develop an effective vaccine. But we need to focus our resources on what is truly needed and what is proven to work. And we need global leadership to meet a global challenge. In 2020, when it is estimated that more than 85 million people will have died from HIV/AIDS, how will we look back upon this day? Will we have proven the experts right with inaction? Or will we have proven them wrong with initiative? I hope that we will be able to say that in the year 2002 we took our stand against HIV/AIDS and began to turn back what could have been, but never became the most deadly disease in the history of the world.

Mr. FRIST

Mr. FRIST. Madam President, I rise today to discuss a very critical bill--S. 2590, the ``Patient Safety and Quality Improvement Act.'' This bill, which Senators Jeffords, Breaux, Gregg, and I introduced in May, represents our next step in reducing the number of patients harmed each year by medical errors. Although a variety of patient safety initiatives are underway in the private sector as well as within the Department of Health and Human Services, Congress has an important role to play in reinforcing and assisting these efforts. Today, the House Ways and Means Committee is expected to report a bipartisan bill--a bill that is almost identical to its Senate counterpart--that will help improve the safety of our health care system. Additionally, President Bush has highlighted the importance of this issue by formally supporting this crucial legislation. Moreover, this bill is supported by over thirty different health care organizations. Mr. President, I will ask that a list of those supporting organizations be included in the Record. As a physician and a scientist, I know the enormous complexities of medicine today and the intricate system in which providers deliver care. I also recognize the need to examine medical errors closely in order to determine where the system has filed the patient. One method used in hospitals is the Mortality and Morbidity Conferences, in which individuals can openly discuss patients' cases and examine problems in detail. Unfortunately, because those conferences represent a single, internal hospital event, we cannot obtain valuable, systematic information about problems or information that could be shared to allow providers to learn from each other's mishaps. Therefore, there is a need to create a broader, more inclusive learning system that encompasses all components of the health care system. One impediment to that learning system is an inability to more closely examine patient safety events without the threat of increased litigation. The Institute of Medicine's report, To Err is Human, as well as experts who testified for the past few years in a series of Senate and House hearings, strongly recommended that Congress provide legal protections for information gathered to improve health care quality and increase patient safety. Without these protections, patient safety improvements will continue to be hampered by fears of retribution and recrimination. If we are to change the health care culture from ``name, shame, and blame'' to a culture of safety and continuous quality improvement, we must provide these basic protections. However, we must be careful not to provide legal immunity for information that would normally be available for litigation, such as medical records. Rather, we should protect information that would be gleaned from providers' investigations of patient safety events. This information is not currently being reported in a way that would allow us to learn from our errors and improve the safety and quality of care for our patients. Additionally, we must ensure that, in extreme circumstances, such as a criminal or disciplinary proceeding, the patient safety data is not used as a shield. In those circumstances, it is imperative that the information be shared, as disclosing that information is material to the proceeding, within the public interest, and not available for any other source. In this manner, we provide a balancing test--weighing the public good in sharing the information and providing the appropriate legal protections so that the system can be improved with the people good in weeding out the ``bad apples.'' In crafting this legislation with Senators Jeffords, Breaux, and Gregg, we were careful to concentrate on the learning system and provide appropriate legal protections for that system. We view this as an essential first step in the ongoing, dynamic process of improving patient safety. I also want to reassure my colleagues that this approach to improving medical care--providing limited confidentiality protections to ensure that we learn from the system--is not new to health care. Currently, there are at least five health care examples which use Federal confidentiality and peer review protections--the Centers for Disease Control and Prevention's National Nosocomial Infections Surveillance System, NNIS, the Food and Drug Administration's MedWatch, Veterans Health Administration, VHA, and the Centers for Medicare & Medicaid Services Quality Improvement Organizations, QIOs. Each of these confidentiality and peer review protections have improved the delivery of health care. NNIS is a voluntary, hospital-based reporting system established to monitor hospital-acquired infections and guide the prevention efforts through description of the epidemiology of nosocomial infections, antimicrobial resistance trends, and nosocomial infection rates to use for comparison purposes. Since its inception in 1970, there has been a 34 percent reduction in the number of nosocomial infections. This dramatic decrease can be attributed, in part, to the availability of data for analysis and identification of system errors that were contributing to high rates. By law, CDC assures participating hospitals that any information that would permit identification of any individual or institution will be held in strict confidence. This allows hospitals to report accurately without fear of negative repercussions. MedWatch is a voluntary Medical Products Reporting Program for quickly identifying unsafe medical products on the market. Through MedWatch, the Food and Drug Administration officials work to improve the safety of drugs, biologics, medical devices, dietary supplements, medical foods, infant formulas, and other regulated products by encouraging health professionals to report serious adverse events and product defects. Once an adverse event or product problem is identified, FDA can take any of the following actions: labeling changes, boxed warnings, product recalls and withdrawals, and medical and safety alerts. The aggregation of information through MedWatch has lead to drug recalls, such as Felbatol and Omniflox, and to label changes on approximately 30 percent of the New Molecular Entities each year. To address the need for a non-punitive confidential reporting system, the VHA developed and continues to implement an innovative systems approach to prevent harm to patients within Veterans Administration's 163 medical centers. VHA has already implemented nationwide internal and external reporting systems that supplement the current accountability systems. Thus far, efforts have led to the implementation of physician ordering systems and safety bulletins, such as the proper handling of MRI equipment. QIOs monitor and improve the quality of care delivered to Medicare beneficiaries. All information collected by QIOs for quality improvement work is non-discoverable. QIOs work directly and cooperatively with hospitals and medical professionals across the country to implement quality improvement projects that address the root causes of medical errors. QIOs use data to track progress towards eliminating errors and improving treatment processes. For example, the latest available national data, 1996-1998, show QIO projects resulted in 34 percent more patients getting medications to prevent a second heart attack; 23 percent more stroke patients receiving drugs that prevent subsequent strokes; 12 percent more heart failure patients getting treatment needed to extend their active lives; and 20 percent more patients hospitalized with pneumonia receiving rapid antibiotic therapy. I appreciate the efforts made by Senators Jeffords, Breaux, and Gregg thus far and look forward to working with them and others to pass this bipartisan legislation. I also value the leadership of the Bush Administration and my House colleagues on this critical issue. I hope that the Senate can also consider this important issue and come to a resolution in the near future. I ask unanimous consent that the list of supporting organizations be printed in the Record.

Mr. FRIST

Mr. FRIST. Madam President, I rise in support of the Hagel-Ensign bill because it really strikes right at the heart of what seniors expect from our Government as they look at their health care and as they look to their future. When I talk to seniors as I travel around the great State of Tennessee and the country, they tell me a very simple and straightforward message regarding prescription drugs: Please, when you go back to Washington, enact a prescription drug benefit and do it now. Do not do it 3 or 4 years from now--implementing the program in 7 or 8 years. What I want is something now; do it now. The beautiful thing about the Hagel-Ensign bill--and I congratulate the authors and sponsors and cosponsors--is that it is the only bill that has come to the floor of the Senate that enacts a prescription drug benefit now. Our seniors deserve an affordable, immediate prescription drug coverage. That is No. 1: Do it now. This is the only bill we have considered that accomplishes that. No. 2: do it responsibly. That is where the debate has changed a lot compared to 2 years ago or 4 years ago or even prior to the last election a year and a half ago. Our seniors today, individuals with disabilities and the future generation of seniors say: Do it now, but do it responsibly. Responsibly means to have a bill on the table that can be sustained over time, which does not sunset or have a narrow window of applicability. Do it now; do it responsibly. Yesterday, we talked about bills on the floor that cost $800 billion or, over a full 10-year period, $1 trillion, and that did not pass. Additionally, we debated a bill that cost about $370 billion. That bill did not have sufficient votes for the point of order. Today, we are talking about a bill that costs less than $200 billion--well within what we have budgeted. Even more importantly than cost, is that this particular bill captures the power of what is called competition or the marketplace. What that means is what we pass today in terms of benefits, in terms of the prescription drug card, and in terms of the catastrophic coverage will be able to be sustained over time. When you capture the element of competition in the delivery, what you say is that there will be prudent tradeoffs, and decisions made regarding--whether it is inpatient hospital care, acute care, chronic care, preventive care, or prescription drugs. When I say ``tradeoffs,'' I don't mean lessening of the benefits. I mean bringing people to the table so rational decisionmaking can take place, given that the benefits that are promised need to be matched with the resources that are available. The Hagel-Ensign bill is immediate, affordable, and permanent. It is not promised just for a period of time. Finally, it is market based-- capturing the power of competition so that it can continue to deliver the benefits over time. For that reason, I am excited about this bill. I urge my colleagues to support this bill. We will have the opportunity to debate and discuss the details over the next 2 hours. In short, it is a prescription drug card where every senior who participates can get a discount instead of paying retail for drugs. Additionally, there is a cap as to how much they will have to pay out of pocket. This cap provides seniors with security and peace of mind that in the event they are struck by a lymphoma, heart or lung disease and have to buy prescription drugs that they will only have to pay a certain amount. For those reasons, I urge support for this immediate, affordable, permanent, and market-based plan.

Mr. FRIST

Mr. FRIST. I yield myself 3 minutes. Madam President, soon we will vote on one of the most important matters facing the Nation--whether to provide within Medicare a prescription drug benefit. In order to strengthen Medicare, we must include affordable prescription drug coverage as part of the package. Too many seniors today find prescription drugs unaffordable. The high cost of prescription drugs serves as a barrier between seniors and the health care security they deserve--which this body has promised them. There is only one proposal that accomplishes the goal of modernizing Medicare and including a prescription drug benefit within Medicare: that is the tripartisan bill. Senator Snowe, a Republican, Breaux, a Democrat, Jeffords, an Independent, Hatch, a Republican, Grassley, a Republican, Collins, a Republican, and Landrieu, a Democrat, collectively have sponsored this bill which reduces the cost of prescription drugs and provides a stable and sustainable prescription drug benefit. The word ``sustainable'' is critical. The tripartisan bill provides low-income seniors and those with initially high drug costs special additional coverage in order to give them security. It expands and improves Medicare benefits under the traditional Medicare fee-for-service program that seniors and individuals with disabilities are comfortable with and understand today. It begins the critical element of instilling competition as we seek to add a new benefit--which means prudent decisionmaking will be made. The tripartisan bill is designed to be permanent, sustainable, affordable and responsible. Even though the cost--$370 billion--goes beyond what was intended in the initial budget, I believe it is a reasonable first step. In closing, the tripartisan bill is not perfect, but it is clearly more responsible than the alternative bill. Many think $370 billion, the cost of this bill, is high. And it is high, especially since it is not coupled with as much reform as I think will be required to ultimately strengthen Medicare. Additionally, the bill lacks some of the necessary reforms that are needed to make Medicare truly sustainable--considering that the number of seniors will double in the next 30 years. Finally, the bill is not immediate, but neither is the alternative bill. The time to help seniors is now. We must act now, act responsibly, and implement a plan that can be sustained. I will support the tripartisan bill because it provides the best and only real opportunity for progress this year on this important issue. I reserve the remainder of my time.

Mr. FRIST. Madam President, how much time do I have?

Mr. FRIST. And the other side?

Mr. FRIST

Mr. FRIST. I thank the Chair. Madam President, seniors can take this card in and get discounts, resulting in savings to seniors right now. Catastrophic coverage gives security, peace of mind. Using marketplace tools is important as we look ahead because it takes advantage of the marketplace in negotiating discounts that are not available today. Madam President, I close with the statement that I believe the Hagel- Ensign bill brings to a head much of the discussion today in that it reaches out and gives seniors the security they want. It does it now. It does it in a way that is responsible. It is affordable for seniors, affordable for taxpayers, and is permanent. Madam President, I yield the floor.

Mr. FRIST. Madam President, how much time remains on our side?

Mr. FRIST. And the time on the other side?

Mr. FRIST. Madam President, will you notify me when I have 1 minute remaining. I rise in support of the Hagel-Ensign Medicare Prescription Drug Discount and Security Act of 2002. I do so after a long day of debate, discussion, and votes on bills which attempt to reach out with affordable prescription drug coverage for our seniors. Over the course of the day's debate, we have touched upon what matters most to seniors. That is what I want to address in the next 3 or 4 minutes. What do seniors who are listening today--38 million Medicare potential recipients who are seniors today and another 5 or 6 million individuals with disabilities--what do they want regarding prescription drug coverage? I think it is three things. The first issue is that seniors want security. They want peace of mind. When you are 65, 70, 75, 80 years of age, the most frightening thought is that in those final years of your life you develop something--whether it is heart disease, chronic lung disease, emphysema, or lymphoma--and all of a sudden you face high prescription drug costs which are skyrocketing. We know this is an issue--we have been talking about that all week long. In essence, paying for prescription drugs bankrupts you in terms of what you can afford and, even worse than that, what your children may be able to afford. The beauty of this particular bill is that it addresses that peace of mind, that security. The second issue I hear as I talk to seniors as I travel around Tennessee, and it has been discussed a lot on the floor today, is that, with regard to prescription drugs, seniors want help now. They listen to the debate, and both of the bills discussed earlier today have some very good, substantive issues to them, are comprehensive, and each have pluses and minuses. But the defect that both bills have that the Hagel- Ensign bill does not have is this bill takes effect, in essence, right now. That is what seniors want. Seniors who are listening may think: Why talk about a bill taking place in 2006 or 2005? I do not even know if I am going to be around 3 or 2 years from now. What they really want is help now. Those who need it want it now. The message they tell me is to do it now. Again, the Hagel-Ensign bill takes effect next year, not 2 years and not 3 years from now. The third factor this bill does is it addresses prescription drugs in a responsible way. We are not in a world today or in a country today where you can just throw unlimited money and say it will be taken care of by the next generation or by my family 5 years from now. This is especially true when we have a doubling of the number of seniors, the demographic change, the move of the baby boomers coming online in 2008 and 2010. Seniors tell me, whatever you do, do it responsibly. Do it in a way that is just not over a 3-year period, 4-year period and it disappears, you take the benefit away or raise taxes exorbitantly. Do it in a way that can be sustained over time. Do it responsibly. That is what the Hagel-Ensign bill does. One of the most beautiful aspects of this bill is that we can do it now, and we can do it responsibly. We talk big figures. The dollar figure was $160 billion. It is a lot of money, but it is not the $800 billion or the $1 trillion or even the $370 billion of the tripartisan plan. It takes effect now, giving peace of mind in capping how much money a senior is going to have to pay out of pocket if there is a catastrophe or if a senior develops a disease which requires the miracle medications that are out there today, and it does it in a responsible way. How does the bill work? We have been through the details. The first issue I mentioned was peace of mind, security, and savings. Instead of what seniors are doing now--going to a pharmacy, placing a prescription on the table, and paying a retail price that nobody in this body, most employer-sponsored plans do not have to--they will be able to go in to a pharmacy with a card that they put on the table and take advantage of mass negotiations.

Mr. FRIST

Mr. FRIST. Mr. President, I rise today to applaud the passage of the ``Nurse Reinvestment Act''--the culmination of work to directly address the nursing shortage. This bill, which has combined portions of S. 726--the ``Nursing Employment and Education Development, NEED, Act'' and S. 706--the ``Nurse Reinvestment Act'' outlines a comprehensive approach to the nursing shortage by focusing on recruitment, education and retention of nurses. I want to thank Senators Hutchinson, Kerry, Jeffords, and Mikulski for their leadership in this issue. This crucial legislation provides for public service announcements at both the State and Federal level to educate the public about the advantages and rewards of nursing. Additionally, this important legislation assists us with training future nurses and future nursing needs by establishing a focus on geriatric nursing, establishing a faculty loan program, and focusing on nursing mobility through the development of career ladders. Finally, this bill focus as new resources on retaining nurses to the profession by establishing a National Nurse Service Corps and by increasing the emphasis on retention within basic nurse education grants. We are in the midst of a nursing shortage. Not only are fewer people entering and staying in the nursing profession, but we are losing experienced nurses at a time of growing need. Today, nurses are needed in a greater number of settings, such as nursing homes, extended care facilities, community and public health centers, professional education, and ambulatory care centers. Nationwide, health care providers, ranging from hospitals and nursing homes to home health agencies and public health departments, are struggling to find qualified nurses to provide safe, efficient, quality care for their patients. Though we have faced nursing shortages in the past, this looming shortage is particularly troublesome because it reflects two trends that are occurring simultaneously: (1) a shortage of people entering the profession and (2) the retirement of nurses who have been working in the profession for many years. Over the past 5 years, enrollment in entry-level nursing programs has declined by 20 percent, mirroring the declining awareness of the nursing profession among high school graduates. Consequently, nurses under the age of 30 represent only 10% of the current workforce. By 2010, 40 percent of the nursing workforce will be older than 50 and nearing retirement. If these trends are not reversed, we stand to lose vast numbers of nurses at the very time they will be needed to care for the millions of baby boomers reaching retirement age. Therefore, we need to focus on both recruitment to and retention within the nursing profession. Further, greater efforts must be made to recruit more men and minorities to this noble profession. Currently, only 10 percent of the registered nurses in the United States are from racial or ethnic minority backgrounds, even though these individuals comprise 28 percent of the total United States population. In 2000, only 5.9 percent of the registered nurses were men. We must work to promote diversity in the workforce, not only to increase the number of individuals within the profession, but also to promote culturally competent and relevant care. Even if nursing schools could recruit more students to deal with the shortage, many schools could not accommodate higher enrollments because of faculty shortages. There are nearly 400 faculty vacancies at nursing schools in this country. And, an even greater faculty shortage looms in the next 10-15 years as many current nursing faculty approach retirement and fewer nursing students pursue academic careers. Therefore, the faculty develop piece within this legislation is crucial to dealing with this shortage. Further, in examining any nursing shortage, we must recognize the potential effects of this looming shortage on patient outcomes. A recent study by Jack Needleman, Peter Buerhaus, and others, found a direct link between nurse staffing levels and five inpatient outcomes-- urinary tract infections, pneumonia, length of stay, upper gastrointestinal bleeding, and shock. To provide an appropriate emphasis on patient outcomes, we have increased the emphasis on examining patient outcomes within this legislation. Additionally, shortages of nurse aides parallel the trends seen in relationship to nurses. Nurse aides are primarily employed in nursing home settings, and some studies have suggested that the average turnover rate for nurse aides is 100 percent. This high turnover rate directly affects both health care costs and patient care quality. Provider costs related to high turnover include recruitment, selection, and training of new staff; use of temporary staff; overtime for current staff; initial reduction of efficiency of new staff; and decrease in nurse aide moral and group productivity. A recent report from the Centers for Medicare and Medicaid Services found a direct relationship between nurse aid staffing levels and quality of resident care. To ensure the appropriate emphasis on nurse aides, we ensured that, where feasible, these facilities and providers were covered within the bill. It has been an honor and a pleasure to work closely with my distinguished colleagues in both the House and Senate, and I look forward to continuing to working with them as we advocate for funding for these particular provisions and ensure that they are appropriately implemented.

Mr. FRIST

Mr. FRIST. Mr. President, I also ask unanimous consent to have a similar letter from the Massachusetts Biotechnology Council be printed in the Record.

Mr. FRIST. Mr. President, the Biotechnology Organization represents over 1,000 biotechnology companies and their members all over the country and in every State. California, Massachusetts, and Maryland have the highest concentration of biocompanies in the United States. I think what people understand and what my colleagues understand is that the biofield is a fairly new field. When I was in medical school, these biotech companies were not out there. The drugs they are looking at today were nonexistent. For the most part, they are in their infancy today. Fifty years from now and looking back, we will see on the curve an increase that right now we are at the beginning of. Of the 130 biotech drugs approved by the FDA, all were produced by fewer than 100 companies. As I just said, there are over 1,000 biotechnology companies that exist today. What that means is, if you have ten companies working at the early research stage to figure out what drug is going to cure HIV/AIDS, or reverse a certain case of emphysema or reverse that blood clot just about ready to cause a stroke in your brain, one company will ultimately produce an effective product. Many of these companies are small, emerging companies. Look at Senator Kennedy's language on bioequivalence. That is the language that will ultimately go into the bill. These letters make clear the concerns raised by myself in committee and others during the Health, Education and Labor Committee markup. The bioequivalent language in the underlying bill has not been addressed. You heard Senator Hatch's plea. Even if this bill sails through, please listen to us and allow us to participate in changing that language. Let me just say that I also share the concerns of others about the codification in this bill. Let me quote from their letter only three sentences. This is from the biocommunity. . . . section 8 as currently drafted goes well beyond the intended purpose of the provision. In essence, the proposed changes would make it impossible for drug manufacturers, whether pioneer or generic, or members of the public, to challenge improper standards enacted by the agency on key approval criteria, or to challenge improper decisions made under valid authority. Moreover, the current regulations include several provisions in which FDA provides to itself unfettered discretion to create or define at will any standard ``deemed adequate by FDA.'' This makes an otherwise legitimate challenge to an agency decision virtually impossible to sustain. Shielding the agency from actions to challenge its proper authority simply makes no sense, particularly when the consequences involve potential risks to patients and to public health. Bioequivalence--again, that is probably the last time I will be able to address this issue on the floor. It is a plea that we work together and come to an agreement so we do not accomplish a loosening of these standards. The Senator from Utah also mentioned the 30-month stay provisions. Let me just say that this 30-month stay provision has served a very important purpose. If you look back at the legislation, which is consistent with remarks from the Senator from Utah, you will see that the 30-month stay is part of the balancing act between the brand name pharmaceutical companies, which are heavily invested in R&D, and the cost-effective generic companies to achieve that balance, which we have seen is so important. As I have said, it has been the magic over the last 16 to 18 years. We need to be very careful when we start tinkering with that and whether or not that goes too far in upsetting that balance. I know and my colleagues know that there have been huge abuses by some brand name companies versus the generic companies in our discussions. They have filed what are late patents. They file late patents that may not represent significant medical advances. Their purpose is because they saw the law written this way as simply to extend that 30-month stay protection period. And they are protected. When you have that sort of protection, obviously, it affects prices throughout. The legislation before us would treat patents, listed after a new drug application is approved, differently than patents listed when a new drug application is approved. Providing lower protections to patents at any point in time will have real implications in terms of innovation, in terms of incentives to innovate as you develop new formulations and new aspects of drugs. There are a whole slew of examples where these patents that are issued, not early on but later, could involve an important innovation. I will not go through the examples here today, but we have talked about them in our Health, Education, Labor, Pension Committee. So if you have a new drug here, a patent here, and you can improve on that drug later in the life cycle, that improvement needs to be protected in some way. Furthermore, you need to give a pharmaceutical company an incentive, which is what this patent protection is. That is what patents are all about: an incentive to look at a new formulation of that drug that could be important. There was a question, a few minutes ago, about certain populations. For example, this applies very specifically to the pediatric population. If you have a drug that can either be injected or be applied intravenously inside a vein, and you have a patent on that drug, it would be nice to give somebody an incentive to make sure you can use that same drug in a liquid formulation, to give them some incentive to develop that liquid formulation. And it may come later in the cycle of that drug. In fact, two weeks ago Dr. Tony Fauci of NIH was quoted in the New York Times about the importance of developing an oral formulation of a drug that was discovered as an injectable drug to treat HIV/AIDS. Forty million people in the world today with HIV/AIDS are struggling in countries, such as in Africa, where two out of three of these cases are today. Many of my colleagues, on both sides of aisle, are trying to figure out how we can link prevention, care, and treatment. The problem is, treatment today is just so expensive. So we want to incentivize people to take an injectable drug, which is very difficult to administer throughout Africa, and develop an oral formulation of that particular drug. Dr. Tony Fauci talked about the importance of developing and patenting an oral formulation of this drug. Unfortunately, that is the kind of new patent, on a previously discovered drug, that would be afforded less protection under this bill. When you afford something with less protection, it is true that fewer companies, fewer people, are going to be interested in investing and figuring out that new formulation. Again, because the distinguished Senator from Illinois mentioned the pediatric population, it brings to mind the fact that we worked very hard on what is called a pediatric exclusivity bill. We unanimously passed it in the Senate. It provides a market incentive for brand-name drug companies to test certain drugs in the pediatric population. Many of us were cosponsors of that bill, and it unanimously passed in this body. It provides a market incentive for brand-name drug companies to test certain drugs for pediatric use for which the FDA issues a written request. We gave certain protections. Now, all of a sudden, we are saying: Well, maybe or maybe not in the pediatric population. Let's lower the protections that we are giving instead of increasing the protections-- which was the intent of this body--and give less legal protection just because of the timing in which a patent was filed. The issue is complex, as Senator Hatch has said. People say, you are being critical of it. You illustrate the problems. Are there better approaches? The answer is, yes, there are better approaches, to my mind, that I hope we will have the opportunity to debate. One approach would be to not allow brand companies to automatically extend the 30-month stay for patents issued after the filing of what is called an abbreviated new drug application--what is called an ANDA--by a generic company. Another alternative would be to allow an additional 30-month stay only for patents that were filed but not approved by the Patent and Trademark Office at the time of the NDA. The impact of this would be to reduce incentives for brand companies to ``game'' the system, something that all of us want to avoid-- companies coming in and trying to take advantage of whatever structure we set up. The fifth point that I want to bring up, in the hopes that we will be able to come back in some form to be able to address these issues, is the broad bar on patent lawsuits. Senator Hatch also raised this point, for the record. I am troubled by provisions in the bill that cause patent holders to lose their rights to sue for infringement of a patent if the patent holder does not meet certain requirements, including these timing requirements. For example, a patent holder would lose its right to sue for infringement if it does not submit appropriate patent information to FDA within the specified deadline, or if it does not bring an infringement lawsuit within 45 days of receiving notice from the generic applicant that its patents are being challenged. I believe this fundamental change, of which the Senator from Utah spoke, to the Hatch-Waxman law will force companies to bring more litigation, not less litigation. In our hearing, we kept saying that we want to see less litigation. It will force more companies to bring more litigation to avoid the risk that otherwise they will waive their rights for all time. If they do not sue, they are going to waive those rights for the future. That is a concern to me, especially as we are looking to decrease the number of lawsuits and decrease overall cost. In fact, as I understand it, this provision alters basic rights that go with a patent, rights that give brand-name drug companies the incentives, as I mentioned earlier, to improve upon existing products. I have to ask: What happens if a patent owner does not have a good- faith basis to sue at some point in time, but later learns something that would give him reason to sue for infringement? The answer is that that patent holder is simply out of luck. America's research institutions and academic medical centers would clearly suffer under the ``list-it-or-lose it'' or ``sue-or-suffer'' provisions of this bill. Under these provisions, NDA holders are required to file patents that meet listing criteria whether or not they own or have a license under those patents. Under the bill, patent owners will be lose their rights to enforce their patents if the NDA holder fails to list, and the patent owners can do nothing about that (only NDA holders, not patent owners, have the ability to list patents). For example, suppose Harvard University owns a patent on a drug substance discovered by one of its academic researchers. Normally Harvard would license that patent to a brand name pharmaceutical company that would develop the drug and submit an application for approval to the FDA. Under the bill before us, if that brand name company failed to list the patent within the arbitrary 30 day period, Harvard, the patent owner, would irreparably forfeit its ability to enforce its valuable patent rights against any generic drug applicant forever. This is true even if a company completely unrelated to Harvard develops a drug that might potentially be claimed in a Harvard patent. Under this approach, Harvard, which has not control over the timing of the listing, would suffer a complete loss of its patents rights against generics without any recourse or ability to remedy the situation. That is both arbitrary and punitive. While we are acting, in large part, over these next several days out of concerns over health care costs, as I mentioned before, the Senate has no formal cost estimate from the Congressional Budget Office, the Office of Management and Budget, or really any other credible source. I mention that only because the overall assumption--and what we would all like--is that whatever we pass here will ultimately bring costs down. But we do not have any outside independent evaluation of that. While we are acting aggressively to curb past abuses, we do not have the benefit, as you have heard from Senator Hatch and myself today, of the ongoing information that is being compiled by the Federal Trade Commission. The FTC has been specifically charged with the investigation of potential abuses by brands and generics. I believe and I am confident this report will provide crucial additional information. As Senator Hatch has said: We just simply don't have the facts. I look forward to working with my colleagues on these issues. Again, Senator Hatch and I have spent a long time outlining our concerns, in large part, because I do not think we are going to be in the climate--I know we are going to other very important amendments about extending prescription drug coverage to seniors--that each of these very technical issues are going to be able to be adequately debated, but also to write in language that would fulfill the intentions on the floor, and that we are going to reach out and hopefully have that opportunity to work together on these. I will likely end up, for the reasons I have outlined, voting against this underlying base legislation, despite the good work and the incremental advantages that have been added to this bill by Senators Collins--and I mentioned most of them--Edwards, Gregg, Hutchinson, and many of my colleagues. The bottom line is, the balance is critical. Balance has been achieved to a very successful degree, much better than I would think anybody would have anticipated in 1984 from the Hatch-Waxman legislation. It is the magic as to why it has worked. It is why we have seen this proliferation of generic drugs and, at the same time, preserving the innovation and research. What I am afraid is that in the legislation as written, we have gone too far. Going too far could indeed have a detrimental impact on research and innovation and the public good, without providing the cost savings promised by its supporters. Mr. President, I yield the floor.

Mr. FRIST. I am happy to yield for the question.

Mr. FRIST. Mr. President, I rise to extend in many ways the comments made by the Senator from Utah. At the outset, I not only express my respect and admiration for his eloquent remarks, but also for the tremendous commitment he has shown on this particular issue over the last 20 years, especially with the Hatch-Waxman law which for the last 18 years has achieved so much for the benefit of the American people. The Senator from Utah has shown a commitment and has shown real foresight, in sponsoring and authoring--along with other colleagues in this body--the original Hatch-Waxman bill in his eloquent analysis of the legislation before us, as has been modified and improved markedly in the Health, Education, Labor, and Pensions Committee. He has also provided an excellent analysis of the underlying McCain-Schumer bill and some of the deficiencies he sees within this legislation. After listening to his remarks, I think the underlying message was the real beauty in this legislation and in the original Hatch-Waxman legislation in achieving a sense of balance between the brand pharmaceutical companies and what they achieve through research and development, creativity and innovation, that balance with the growth and the appropriate incentives given to the generic community, where we know that cost-effectiveness has been demonstrated and needs to continue to be demonstrated as we move forward. We need to keep this in mind especially in this world with skyrocketing drug costs, which are putting the cost of pharmaceuticals out of the reach of seniors, of everyday Americans, and of individuals with disabilities. Much of the discussion over the last 3 days has been on how best to provide seniors and individuals with disabilities in Medicare access to prescription drugs, and that debate will continue into next week. Throughout this entire discussion is the whole issue of cost--what we need to do responsibly that can be sustained long term in terms of cost to make sure the cost of drugs are appropriate, reasonable, and not beyond the reach of Americans. The Hatch-Waxman law has had 18 years of balance, and now is the time to go back and readjust and make sure that balance is well situated for the next 5, 10, 15, or 20 years. I heard the distinguished Senator from Utah say the legislation, as currently written--and recall he commended the various amendment processes in the HELP Committee to improve the bill--goes too far in correcting what is out of kilter today. That balance needs to be readjusted. The underlying legislation has many deficiencies that he believes, and I agree, should be addressed. I will walk through several of those from the perspective of having served on the Health, Education, Labor, and Pensions Committee. The issue of cost is one that disturbs everyone. It is at the heart of the discussion on health care and on extending prescription drugs in an affordable way, in a bipartisan way, to seniors and individuals with disabilities. The cost is not just in the public sector but the private sector as well. The skyrocketing cost is driving people to the ranks of the uninsured. As we look at the overall skyrocketing cost of health care, the cost of prescription drugs is increasing in a way that cannot be sustained over time. In the name of cost savings and in the name of reaching out and rallying support for particular pieces of legislation or amendments focusing on cost savings, never should we threaten public health, which we talked about yesterday. Furthermore, never should we threaten the research and innovation that has made us the envy of the world in terms of health care--the great breakthrough drugs, the investment in research and delivery, which eventually will deliver a cure for things which are not curable today, such as HIV/AIDS. That virus will kill somewhere around 60 million people over the next 20 years. We do not currently have a cure, however, I am confident a cure will be found by research and development from our pharmaceutical companies. The Hatch-Waxman Act has served us very well. As the distinguished Senator from Utah said, generic drugs represented only about 20 percent of the market in 1984. Yet today, half of all drugs in this country are generic which, again, is a huge advance. At the same time, we have been able to see this rise in the generic industry, which I advocate because of the cost-effectiveness that is demonstrated there because of the balance we have. The brand name pharmaceutical companies have continued to invest in research and development. Over that same period of time since 1984, that research and development by the brand name pharmaceutical companies have increased not twofold, threefold or fivefold but have increased ninefold since 1984. We have seen dramatic breakthroughs in pharmaceutical treatments for such areas as mental health, cancer, and heart disease. Costs have put drugs out of reach for too many Americans today, and we must address that. Over time, both the generic industry and the brand name pharmaceutical companies have, unfortunately, circumvented the intentions of Hatch-Waxman. That circumvention is clearly an abuse because it ultimately drives up the cost of health care, and it must be addressed. Adjustments are in order. What concerns me and what clearly concerns the original author of the Hatch-Waxman legislation, the Senator from Utah, is that this underlying legislation goes too far. I will comment on several of the areas. First, I restate the legislation in the Senate today is currently much improved over the original Schumer-McCain legislation introduced last May. The original version of S. 812 took a heavy-handed approach to this very real problem. It would have dealt a serious blow to pharmaceutical research and innovation, which we all depend on as we look for potential cures and potential therapies in the future. My colleagues, Senators Edwards, Collins, Gregg, Hutchinson and others should be commended for working with the chairman of the Health, Education, Labor, and Pensions Committee. Senators McCain and Schumer also worked to approve the legislation. Nevertheless, the bill before us has significant flaws. Let me briefly outline several of my concerns. First, we are focused most importantly on cost savings, the driving force. Everyone knows the costs are too high. It is important for our colleagues to understand there has been no demonstration that the underlying legislation will actually save money, lower the overall burden of prescription drugs and generic drugs in the aggregate to either consumers or in the aggregate in terms of the overall health care dollar. The intent of the authors has been clear--the goal of the legislation is to improve competition. If improving competition is achieved, and I have real questions about whether competition will be improved as written, I believe costs will decrease. It will speed cheaper generic drugs to the market, which is the intent of the authors of this legislation. Part of the legislation discussed today is clearly being promoted because of the intent, or what the proponents say it would do, and that is to lower costs. The real question is, Does it? Is there any evidence that it will do so? The Congressional Budget Office, to the best of my knowledge, has not scored this piece of legislation. By score, I mean it has not estimated the cost of this legislation. Neither this legislation nor the original bill introduced by Senators Schumer and McCain has been analyzed by the CBO. As you listened to Senator Hatch's eloquent comments earlier and you listened to the complexities of this bill, I ask, Does this increased complexity and new cause of action actually contribute to increasing costs? Lastly, I am not aware of any other estimates of potential savings by independent, nonpartisan experts that members of the Senate will have a chance to review before we go forward. My second point refers to how best to curb abuses. The whole idea of curbing abuses is a common goal that we share in the underlying legislation, in the amendment process, and in the H.E.L.P. Committee. As Senator Hatch again spelled out in his comments, the Federal Trade Commission is currently conducting an extensive study of potential abuses in this area. As we discussed in the hearing several days ago and as Senator Hatch requested, the FTC is preparing a report regarding this area. It would be nice to have an objective body like the Federal Trade Commission present its data before we potentially complicate legislation over the next several days and weeks. Unfortunately, we are not going to have that opportunity. It is too bad because as I understand it, the real problem is being made in terms of the Federal Trade Commission's ongoing study. Current law, as we look at the 180-day exclusivity provision, provides an incentive for the first generic that challenges an innovator's original patent. It awards that generic company 180 days, or about 6 months, during which other generics may not be approved. The bill before the Senate, which is quite different than the original legislation, provides that if one generic loses that 180 days of exclusive rights, it can pass on to the next generic. I am told the 180-day exclusivity rule has been the most frequently litigated area of the Hatch-Waxman legislation over the last several years. I am concerned and again this understates the concern of Senator Hatch. The provisions in the proposed bill are overly complex and they might actually encourage even more litigation and promote even greater confusion in this area. As Senator Hatch mentioned, during the Health, Education, Labor, and Pensions Committee's evaluation, we reached out to understand the language in this particular bill. I have to admit that the new bill's language was confusing to me, but at the end of our discussion, my interpretation as we listened to the proponents of the bill is that the 180-day exclusivity period would allow, theoretically, a rollover indefinitely. If that is a correct interpretation, it could actually take longer for cheaper generic drugs to get to the market. While a generic drug would be cheaper during this 180-day period than a brand name drug, it certainly would be more inexpensive during the 60-day or 180-day exclusivity period, where it had absolutely no generic competition. Last May, Senator Hatch and others were highly critical of a concept of rolling exclusivity when they testified before the Health, Education, Labor, and Pensions Committee. In fact, Senator Hatch testified and quoted former Acting Director of FDA's Office of Generic Drugs, Gary Buehler, as follows: We believe that rolling exclusivity would actually be an impediment to generic competition. Senator Hatch further stated: If our goal is to maximize consumer savings . . . it is difficult to see how rolling exclusivity achieves this goal. In fact, many experts believe and have expressed that the 180-day exclusivity period is no longer necessary today, and that if it were abolished, even more significant cost-savings could be achieved. Moreover, eliminating the 180-day provision altogether, in my opinion, could be the best way to curb abuses currently being investigated by the FTC--where brand companies and generic companies have allegedly entered into collusive and potentially anti-competitive agreements to prevent cheaper generic drugs from coming to market and benefitting consumers. My main point is if we are going to act in the absence of the FTC report, which examines this very issue and their findings, we clearly should not add confusion to this area. We should not add provisions which would increase litigation or increase costs, and we should not add provisions that could exacerbate incentives for anti-competitive behavior by both generic and brand name drug companies. This is the area we need to fix. If we are not ready to eliminate this 180-day rule or wait for the FTC report to help guide us on how we can make that ultimate decision and act responsibly, I believe what is called a ``use it or lose it'' policy would better discourage anti-competitive behavior. This so- called ``use it or lose it'' policy would take away incentives for generic companies to make their own potentially anti-competitive arrangements. Senator Gregg initially proposed this ``use it or lose it'' policy during the Health, Education, Labor, and Pensions Committee consideration of this legislation. I believe this policy would clearly benefit consumers more than any form of ``rolling'' exclusivity. If we are going to act in the absence of the full report of the FTC, we ought to at least to do so in a straightforward way that promotes competition and that clearly helps consumers. The third issue I would like to raise is the issue of bioequivalence. This is a particular issue that I introduced in the Health, Education, Labor, and Pensions Committee and spoke a little about on the floor two days ago. Again, it is an issue I want to put out to my colleagues for their consideration. The unintended consequence, in the way this legislation is written, is potentially harmful in a way that I will delineate. The Hatch-Waxman law allows generic companies to market off-patent drugs if they are able to demonstrate this so-called bioequivalence. Bioequivalence simply means the active ingredient in a generic pharmaceutical or a generic drug is absorbed at the same rate and to the same extent as the brand drug. The bill before us--and this is the key point--could significantly weaken this important patient protection by giving the Food and Drug Administration broad authority to significantly relax, to loosen, the statutory Hatch-Waxman bioequivalency standard. My concern is this potential loosening of the standards. We all have agreed--at least in the Health, Education, Labor and Pension Committee discussions, including the proponents of the legislation--that the FDA has broad authority with regard to bioequivalence and that there has not been a successful challenge to the FDA bioequivalence standards as they exist today. Based on existing statutory language the FDA has developed through the process of notice and comment--rulemaking specific bioequivalence test methods to address a range of products have been established over time. They have not been successfully challenged. As we discussed this in committee, the FDA has been uniformly successful in defending its bioequivalence methodology and its findings. In fact, we agreed in committee that the FDA's authority in this area has been repeatedly upheld. There has not been a reported case challenging the FDA's bioequivalence standards since the case was decided in FDA's favor back in 1997, five years ago. Therefore, as we look at bioequivalence, I think it is unnecessary, imprudent, and unwise to include any bioequivalence language in this legislation. Nonetheless, the bill before us would deem FDA's regulations to be authorized under relevant provisions of the Food, Drug, and Cosmetic Act. Again, my concern is that it could insulate the FDA from any potential challenge in this area. The reason I keep bringing it to the floor and talking to my colleagues about this issue is because I hear a lot about it from the medical community, the scientific community, and the biological research and development community. Given the importance of the bioequivalence requirement in assuring the safety of generic drugs, I believe any loosening of standards is in the disinterest of the American people. Why? Because, once again, it goes back to safety and public health. Instead of moving forward, it is moving backwards. There are many examples, but a typical example would be taking a blood thinner such as Coumadin. Coumadin is used all over the country. It is a tremendous drug and a very powerful drug. It is well known that one generic of Coumadin versus another versus yet another behaves in a different way, even if you prescribe the same dose in milligrams. The bioequivalence can be variable and might be tiny, 3 percent, 5 percent, 8 percent. But when the goal is thinning of the blood so you do not have another stroke or heart attack, when you go from one drug to another drug for whatever reason--it might be the pharmacy telling you to do it, it might be your health plan, it might be you who has chosen to do it--your blood might be thin one day and not thin the other, and you think you are taking the same drug. That is what bioequivalency is--where there might be loosening of the current standard. The reason I say there might be loosening is because people who are a lot smarter than I who study the language tell me the language as written looks to be loosening.