Bill Frist

Mr. FRIST

Mr. FRIST. Mr. President, I will be happy to yield to my distinguished colleague.

Mr. FRIST. Mr. President, if I could just briefly respond, and that is where this Medicare+Choice is really the HMO model, although not for everybody.

Mr. FRIST. We have learned a lot from it since 1974. The point is Medicare has not changed.

Mr. FRIST. We can preserve the good of that model but, based on what we know in 2003, add state-of-the-art, quality, partnering-type, coordinated, integrated delivery of health care. That is a great example of traditional Medicare in 1965. We opened up the Medicare+Choice and 5 million people went with it. That is one type of plan. It is not for everybody now because, to be honest, a lot of patients want more choice, and therefore we give them a system that has more choice. That is really what this legislation is all about.

Mr. FRIST. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. FRIST. Mr. President, while we have been in the quorum call, there are a lot of negotiations underway in terms of various amendments being brought to the floor and the ones that are currently here. While I have an opportunity, I want to spend a few moments on a couple of charts I know have helped me and I believe will help my colleagues and others who are paying attention to the debate as to why we are looking at real changes in Medicare and why such changes will result in strengthening and improving Medicare in a way that we just did not do 5, 10, or 15 years ago and why the time is now for us to act. Yesterday, I talked a little bit about the history and the advances that have taken place since 1965, when Medicare was enacted. The advances have been huge. The point I had begun to make was that the advances in health care, health care delivery, medical technology, and science have been huge and dramatic, but at the same time the structure, the system, has been almost frozen in a 1965 model. I will use three consecutive charts. The X axis here will be time, 1965, when Medicare was first enacted, and the present date here, 2003 or 2005. Then on this vertical axis--this is subjective--is change. It is modernization. It is advances. It is differences from 1965 to where we are today. With the third chart, I will put this together. Referring to the first chart--this is change; this is time--Medicare was enacted in 1965. Things didn't change very much in the system until 1972, when coverage was expanded for individuals with disabilities and for a subpopulation that had been missed but was growing, and that is people with kidney failure, called ESRD, end stage renal disease. That was a pretty dramatic change in the system because we changed the entitlement nature and we expanded coverage. We are doing a little bit of that on the floor this week and next week. I will come back to that. It was a reasonable change. In terms of overall change, it wasn't a big change. Then things went for another 13 years, to 1985, until we had the next big structural change in the way health care is delivered to our seniors. That change--we ratchet it up a little bit here in 1985--we had what is called prospective payment for hospitals, inpatient hospitalization. So if you had a patient in a hospital, instead of just reimbursing whatever cost went through, we sat back and said: What should a patient with a certain diagnosis--say, heart disease, or it could be ischemic heart disease--if you took all the patients coming through, what is a reasonable price, looking at everything we knew at that point in time, to reimburse the hospital. That is called the prospective payment system, PPS, for inpatient hospitals. That was an innovative change that was important to overall health care delivery in the system. Then we had several references to what happened in 1988 and 1989. In fact, a lot of people have said to me: We will have to be very careful with what we do; otherwise, we will repeat what happened in 1988 and 1989. Here we had enactment. We passed a bill and then repealed catastrophic coverage, meaning high out-of-pocket expenditures if there was a tragic, unexpected event or an automobile accident where health care costs were just huge, that there would be some limit there. It was nobody's fault. You would have some insurance there to cap how much you take out of your pocket to pay for that catastrophic event in one's life. Here I have a line coming up. And since we repealed it, I have a line going back down. So we attempted a pretty big change at the time, but for all sorts of reasons the system was not quite ready for it and, therefore, it was enacted and then shortly thereafter, in 1989, repealed. Then things didn't change very much until the late 1980s and we had added a prospective payment system for physicians. I mentioned that we did it for hospitals in 1985. So again, we ratcheted up, and the system changed. It was modernized; it was improved in the late 1980s. Since then, we had some other types of changes that didn't dramatically change the system in terms of the way health care is delivered to our seniors but did affect it dramatically. We had the Balanced Budget Act of 1997. We had what is called Medicare+Choice which is predominantly an HMO. What we are talking about in the bill on the floor is not health maintenance organizations. We are talking about a newer, more up-to-date way than HMOs of delivering care called PPOs, which is a preferred provider way of delivering care. It is very different. This is Medicare+Choice, HMO delivery, in 1997. Today, there are about 5 million people in HMOs and Medicare, and although those numbers are falling over time, it is because there are fewer HMOs offering it because of the regulations, the way we reimburse. But the people who are in the HMOs, those 5 million seniors, are very pleased with those plans in the aggregate. We did some other prospective payment changes here but not much change. The point of this graph is that since 1965, the Medicare system, a great system that has served people very well, has not changed very much at a time--and this is what is on the next chart--when technology, medical science, medical advances have all been really quite dramatic over this same period. Indeed, if you look, again, from 1965 to 2003, you see there has been huge growth in health care advances, both science and technology, what we know, the human genome project, delivery of care directly. For example, in 1967, there was the first successful heart transplant and the first liver transplant. I put that on there because that is what I did before coming to the Senate. In 1969, we developed a genetically engineered vaccine. We are trying to go back and pass new legislation called BioShield. As soon as we get finished with Medicare, we have to come back to that legislation because it looks at the importance of vaccines to fight bioterrorism, SARS, and other illnesses. In 1974, this body passed the HMO Act, a new type of delivery system. It hasn't worked out quite as well as anybody would have liked, but it was important to try to deliver health care more efficiently. In 1977, coronary angioplasty developed, where you put these stints in the heart. Before then, it had never been done. In 1984, we talked about HIV/AIDS on the floor. I was a resident at that time, working up in Boston, MA. We didn't even know what that virus was, HIV/AIDS. Since 1981, 23 million people have died from this virus we identified not that long ago. We responded on this floor in a very admirable, bipartisan way, following the leadership of the President. We passed a public health bill that targets this HIV/AIDS virus throughout the world. The first successful single lung transplant was in 1983. In 1985 came preferred provider organizations, a new type of health care delivery system. Over a million people were enrolled. I will jump up to 1998. Now 90 million people are enrolled in this entity that was invented in 1985. Remember, Medicare hadn't changed at all. Medicare doesn't have PPOs in it today, except in a few demonstration projects. Prozac, in 1988, had a revolutionary effect on people when appropriately prescribed for certain disorders. In 1987, there was the first cloned adult animal, Dolly. We remember that. It brings up all sorts of issues we will be coming back to eventually here, including the appropriate role of the cloning, stem cells, and all of the issues that are before us. In 1997, 85 percent were enrolled in managed care. It did not exist in 1965 or 1970. Yet there was 85 percent enrollment in 1997. The human genome project--the Senator from New Mexico just walked in and he is, in my mind, the father of this project. It finished 2 years ahead of schedule, under budget. It really started as an idea here, or was captured as an idea on the floor of the Senate by the distinguished Senator from New Mexico and others as well. Since that point in time, over a 10-year period, there are 3 billion bits of information we now know that we didn't know 10 years ago. There have been tremendous advances, and it opens up a whole new spectrum of innovation, creativity, and technology to benefit untreatable diseases today. This human genome project is exciting. The challenge we have today is to have a Medicare system that can capture that innovation, that technology, and what we learned in better health care delivery, and right now Medicare doesn't do that. Medicare is not designed to do that. Thus, as we look ahead, we need to strengthen and improve Medicare. Now we have the opportunity. If you put these two charts together, it explains why we are on this bill and why we are working hard to negotiate this bill in a way that is bipartisan and looks at health care security for seniors. That is what we want on both sides of the aisle. Shown in red on this chart, Medicare has not changed very much over the last 35 years. Yet we have health care delivery, and science and technology, pharmaceutical research, and heart surgery, lung surgery, and coronary artery bypass surgery wasn't done in 1965, period. Medicare has not changed at all. Health care advances have changed dramatically and will change even more, and it is this gap--for our seniors we are talking about--that we are addressing. How can we sufficiently change Medicare so the line will come up and we can be more in sync with health care advances and health delivery advances with a system that is flexible enough to capture them--whether it is treatment for mental illnesses or whether it is preventive care. There is no preventive care in Medicare today. There is no protection for catastrophic coverage. There is no chronic disease management. Yet our health care delivery system knows that is the most effective way to treat seniors and, indeed, everybody in terms of health care. So what is the response? The gap is what conceptually has changed. I don't have numbers over on this side of the chart because it is concepts. But at least what we are trying to do is bring that forward. What are we going to do? I will go through this quickly. We have seniors today--this is Medicare today--who have two choices. There is traditional Medicare, with 35 million in the program. These are seniors and individuals with disabilities, those two groups. Five million people are in Medicare+Choice. We brought that forward about 5 years ago. Those 5 million are pretty satisfied. They are mainly HMOs, that 5 million. So 35 million are in traditional Medicare, what we call fee for service. It is this traditional Medicare that really has not changed much since 1965. There have been some changes but not many. The next question is, if this legislation is passed, after we amend it and pull things together, what are we going to have in 8 months or a year from now? That will be this chart. It is going to be the same format for the next two charts. We will have, again, traditional Medicare, with 35 million people, and 5 million people in Medicare+Choice. This will alter a little bit. The addition to this will be the prescription drug card. Maybe 6 to 9 months from the time the bill is signed, every senior will have access to a prescription drug card that will allow that senior to go into a pharmacy, a retail outlet, or a mail order house and, with that card being used, will be given a discount of maybe 10, 15, 20 percent. That will be within--I don't know--6 to 8 months when that will take place, while the rest of the system is being modernized. That is in 2004. People need help now. We can give them help now. I mentioned some figures earlier. If you are low income, this prescription drug card can be used just straight right off the top as a benefit. Then the last chart----

Mr. FRIST. Mr. President, in response, I believe it is. Some people would say, no, we can make everything work and improve on everything. In terms of the demographic shift, the fact is, we have doubled the number of seniors. It is unprecedented. It never has happened in the history of this country, or indeed in the world, where a country has doubled the number of seniors over a 30-year period, going from 40 million seniors to approximately 78--really about 37 million to 77 million. At the same time, we have not half but a diminishing number of workers paying into the system. I argue that this is done on quality of care. I just know if one gets into a system where they have a doctor talking to a nurse, a doctor talking to a specialist, that they have preventive care, they have a nurse who specializes in chronic disease management--which is the whole purpose of this coordinated care, that they are getting a higher quality of care. In addition to that, it is a more efficient system. Choice is going to allow people to go to the systems that give the best care, and with that it is sustainable over time because it allows an element of the marketplace to work. The marketplace is nothing more than rational people making rational decisions, and it might be to stay in traditional Medicare. But the argument would be if someone is getting better care over here and better value over time, the PPO model will attract people. The other point I should at least mention, and the reason why I know it can work, is that people who are near seniors say they are 64 years of age and they become 65 years of age about 80 percent of them have similar type plans, although not exactly. They have employer-sponsored plans. So when they get to be 65--not the Senator from New Mexico because he is in the Federal Government and he is already in a plan like this. We have that advantage. We want to give it to our seniors. But for the person who is 64, soon to be 65, when they make it to 65 they give up their employer-sponsored plan and have to take this traditional Medicare. So what we are going to say is when someone hits 65----

Mr. FRIST. They can keep that sort of plan. That is why I am so confident that over the next 30 years this will work because that is what the Senator has, and what I have, and what most employer-sponsored plans are. But that is what we are denying seniors and those with disabilities. That is why underneath I am so confident this can work. We have to make this work. We have to improve it and that is what we can do over the next 8, 9, 10 days.

Mr. FRIST. I was probably in the operating room.

Mr. FRIST. Yes.

Mr. FRIST. I take 1 minute. I know we have other Senators on the floor and we will turn to those Senators. The human genome project which I mentioned a few minutes ago really happened. Completion really took 10 years. There are great advances that will come out of this mapping of the human genome. It is like a phone book we did not used to have, but now we have all that information. There will be tremendous advances out of that. The problem with the Medicare system, which has not changed very much, is those new advances and what we learned cannot be rapidly incorporated into Medicare. I talked earlier about heart disease. Most people know cholesterol is important to heart disease. The cholesterol screening test is not covered by traditional Medicare today. Before seniors could benefit from heart transplants, the private sector was doing heart transplants. It took 6 years before seniors had access to that lifesaving operation. The micromanagement out of Washington, DC, means new technology is slow to come into the system because it is so rigid. If we are going to capture the great advances, we need a system that is receptive, that is flexible. That is what the PPO model does. The demographic shift is critical. The Senator from New Mexico is the expert in this body, having chaired the Budget Committee in such an admirable way, a distinguished way for so many years. Whatever we do on this floor, we have to look 10 years out, 20 years out, 30 years out because of the demographic shift. This plan does that. In terms of the delivery program, it can be sustained over time. Traditional Medicare right now, because of its rigidity, means a doubling in the taxes. Maybe we can do that as we go forward. By giving traditional Medicare improving benefits, and allowing prescription drugs, allowing flexibility, allowing choice to be part of that, it can be sustained long term. I appreciate the comments of my distinguished colleague from New Mexico. I appreciate the patience of the other Senators on the floor. This is an important issue. Every now and then it pays to walk back and look from 30,000 feet at what is going on below. What goes on below determines ultimately what goes on at 30,000 feet. I have enjoyed the opportunity to do that.

Mr. FRIST. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. FRIST. Mr. President, I know we are about to vote in a couple of minutes. I look forward to voting for this very important amendment. I commend the Senator from New Hampshire and the Senator from New York for their tireless work to bring this amendment to the floor in a way that it will receive broad support. It will achieve the objective of lowering the cost of prescription drugs, I believe, by bringing generic drugs to market faster. It will do so in a balanced, responsible way. I also want to take a second to applaud the Senator from Utah, Mr. Hatch, who really showed remarkable foresight in the original Hatch- Waxman bill that has done so much to maintain balance between fostering research and innovation of new drugs on the one hand and expanding accessibility of more affordable generic drugs on the other. The success of that particular bill has been remarkable. I do have several concerns about the amendment. I will be voting proudly for this amendment, but I will state the few concerns I have that I hope we can address over the coming days. The intent of the amendment is clear: To improve competition, to bring high-quality, cost-efficient, and generic alternatives to the market sooner; and this amendment does just that. Mr. President, I want to address the amendment before us offered by Senator Gregg and to commend him for his tireless work to lower the cost of prescription drugs by bringing generic drugs to market faster. Last year, the Senate considered, and I voted against, a proposal to disrupt a system that has worked relatively well for almost 20 years-- the landmark Hatch-Waxman law. And I want to express my respect and admiration for the tremendous commitment and foresight shown by Senator Hatch in sponsoring and authoring--along with other colleagues in this body--the original Hatch-Waxman bill that has done so much to maintain a balance between fostering research and innovation of new drugs on the one hand and expanding the accessibility of more affordable generic drug copies of existing medicines on the other. Under Hatch-Waxman, generic competition has flourished. In 1984, when the law was passed, generics represented less than 20 percent of the market. Today, generic drugs represent nearly 50 percent of the entire market. Yet because of some abuses of the law, S. 812 last year proposed to address the conditions under which generic drugs come to market. Although the bill was intended to speed this process and bring cheaper drugs to the American consumer, I voted against this proposal for a number of reasons, including concerns about the impact the bill would have on public health as well as its possible effect on the development of new, innovative drugs. I shared the concern about abuses to Hatch- Waxman and agreed with issues related to rising drug costs, but the proposal last year simply went too far, way beyond the recommendations contained in the Federal Trade Commission's 2-year study. Therefore, I commend Senator Gregg for the good work he has done on today's amendment. This represents significant improvement from last year's bill in an attempt to address ongoing concerns with last year's proposal. Currently, we are working to provide Medicare recipients access to prescription drugs, and that debate will continue into next week. During this discussion, we must address the cost issue, what current changes we must invoke to maintain the long-term sustainability of this added benefit by ensuring that the cost of drugs are appropriate, reasonable, and not beyond the reach of Americans. The Hatch-Waxman law has almost 20 years of balance, and now is the time to go back and readjust and make sure that balance is well situated going forward. As we look at the overall skyrocketing cost of health care, the cost of prescription drugs is dramatically increasing. But in the name of cost savings, never should we threaten public health. 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 development, which eventually will deliver a cure for diseases that are not curable today. Let me make clear that today's amendment is much improved over last year's proposal, which took a heavyhanded approach to this very real problem and would have dealt a serious blow to pharmaceutical research and innovation. My colleagues, Senators Gregg, Schumer, McCain, and Kennedy, should be commended for their progress. Nevertheless, the amendment still has some significant flaws. Let me briefly outline several of my concerns. Even though these concerns will not prevent me from voting for this amendment, I believe that we must address these issues and I hope my colleagues will work with me in this regard. First, I am concerned by questions that have been raised regarding the constitutionality of a key provision allowing generic drug makers to seek declaratory judgment that the brand's patent is not valid or is not infringed. At the least, it seems likely that this question will generate significant litigation; at the worst, it raises the prospect that all of the work put in on this point may ultimately be for naught if the courts decide that it is unconstitutional. Next, under current law, if the court finds that a person has willfully infringed a patent, then the court awards treble damages. The amendment states that the court need not award treble damages in some circumstances--an alteration of patent rights that would apply only to drug patents and that removes the disincentive for generic companies to willfully infringe patents. While this amendment seeks to codify the recently finalized FDA rule limiting innovators to one 30 month stay, I am concerned that it fails to include a clarification of the Food and Drug Administration's, FDA, current policy that an amendment or supplement to an abbreviated new drug application, ANDA, cannot cover a drug other than the original drug indicated in the ANDA. Without closing this obvious loophole, we are only creating additional problems with the appropriate administration of the 30-month stay and leaving in place a possible manner by which to game the system. The intent of the amendment is clear, to improve competition and bring high-quality, cost-efficient generic alternatives to market sooner. If improving competition is achieved, I believe costs will decrease. However, I believe changes could be made to better improve competition, for example, by allowing a generic firm that may not have been the first to file but is the first to have an approved drug ready for market to obtain the 180-day marketing exclusivity. This would be more proconsumer because it would reward the generic company that actually gets their drug to market fastest, rather than the one that simply was first in line. However, I do comment Senator Gregg for including a ``use it or lose it'' provision to discourage anticompetitive behavior. This is a significant advancement from last year's ``rolling exclusivity'' provision, and will protect consumers from anticompetitive behavior on the part of both brand drug companies and generics. I will support this amendment. However, I believe we must continue to work to ensure the workability of the amendment, to provide that this does not inadvertently increase the health and safety risks to patients, and to avoid setting precedents that could lead to greater confusion and litigation in this area. I thank Chairman Gregg for his work on this issue and look forward to continuing to work with him on this as we move forward. Again, I commend the Senator from New Hampshire for his tremendous support in authoring, sponsoring, and amending this amendment. I yield the floor.

Mr. FRIST

Mr. FRIST. Mr. President, the Senate will resume consideration of S. 1, the prescription drug benefits bill first thing this morning. There are two amendments currently pending to the bill: an Enzi amendment relating to pharmacies and mail-order prescriptions, and a Bingaman amendment regarding asset tests. These amendments are being reviewed, and we will have one of those votes some time early today. The other we will be voting on over the course of today. In addition, of course, we will be considering other amendments both today and tomorrow. The chairman and ranking member will continue to work together to try to get Senators to come forth and offer their amendments, or to let them know what those amendments will be so we can establish a queue for those amendments to be considered today, tomorrow, and, indeed, into next week. I do encourage, as I did yesterday morning, all Members to come forward and let the managers know what amendments they are considering offering. It is important to do so. For example, today we are waiting on one of the amendments to get an official scoring back from the Congressional Budget Office, so even after we hear about the amendments, it takes some time to process them. So it is absolutely critical that we hear from our colleagues in terms of what amendments they intend to offer. We will have rollcall votes throughout today's session. We will be voting tomorrow as well. (Ms. MURKOWSKI assumed the Chair.)

Mr. FRIST

Mr. FRIST. Madam President, I will comment very briefly on two issues, the first is on the Juneteenth observance. Madam President, Juneteenth, which is also known as Freedom Day, is the date on which 250,000 slaves living in Texas finally learned of their emancipation. And that occurred nearly 3 years after President Lincoln's historic Emancipation Proclamation. It was in 1865, on June 19, that Union General Gordon Granger led 2,000 troops into Galveston, TX, with news that the war had ended and that slavery had been abolished. He told the people of Texas: [T]hat in accordance with a Proclamation from the Executive of the United States, all slaves are free. This involves an absolute equality of rights and rights of property between former masters and slaves, and the connection heretofore existing between them becomes that between employer and free laborer. The celebrations that followed began a 140-year tradition. Today, all across the country, Americans of all races will celebrate with prayer, and picnics, food, family, and friends. We join them, here on the Senate floor, to celebrate the struggle for freedom and to honor the profound contributions of African Americans to our Nation's culture and history.

Mr. FRIST

Mr. FRIST. Madam President, one last issue I wish to speak about now is one we will be talking about today and tomorrow on the floor of this Senate, and that is this whole issue of strengthening and improving Medicare. Over the last several days, we have used terms such as ``actuarial value,'' and ``asset tests.'' We hear those terms again and again. We use acronyms so often. We talk about PPOs and HMOs and waiting on CBO for scoring. All these are important issues and vital issues, technical issues that are critical to our decisions that must be made, that we are obligated to make and should make to serve seniors in a better way with regard to their health care. But I do want to step back, just for a second, to set the stage for today's debate, to talk to seniors who might be either watching on C- SPAN or listening on the radio, and try to describe what, from a big picture, from sort of 30,000 feet, what this bill is all about. When I am back in Tennessee, traveling through the State talking to seniors, the questions that I receive are not about reform or private competition or a market-based approach, and how all that is going to work in the bill. It is not how many stand-alone drug provider plans will be on the table. It is not what we have to think about here, what the 10-year cost is, or even the 20-year cost of the benefits we are discussing. Those are critical issues, issues that we must address as we address this historic legislation at this very important time, given the demographics, given the fact that we are talking about a health care system that has not kept up with the great advances in the delivery system and the technology and the medical science that have occurred over the last 30 years. What they ask in these town meetings or in drugstores or when I am walking along on a sidewalk is: How is this going to affect me? I am a senior. I am concerned about my future. I am concerned about if I get sick. I am concerned about the fact that if I have an illness now, how is it going to affect me? Very quickly, the first thing that will happen is in about 6 months, maybe 7 months after the President signs this legislation and makes it law of the land, every senior and individual with a disability on Medicare--every senior--will have the opportunity to get a little card, a Medicare prescription drug card. Every senior will be able to benefit from this little Medicare prescription drug card. When I am talking to a senior, I tell them: You will be able to use this card similar to the way you might have a card for discounts at the grocery store, which is becoming increasingly popular today. We estimate that by using that little card--a card you do not have today; you cannot have today because the law does not allow it, but in 6 or 7 months after this bill is signed into law, you will have a card that will give you a discount of somewhere between 10 and 20 percent, by using that card, compared to the way you are getting your drugs today. That is important to the senior because the senior knows that, yes, this will benefit me. Yes, Government, in a bipartisan way, has addressed the fact that the burden before me is huge. Why can we do that? Because by using the combined purchasing power of up to 40 million people--instead of an individual senior going into a retail store and paying retail dollars for that--all of a sudden that senior, by having that card, becomes part of a huge purchasing group of as many as 40 million people. If you are living alone and your income is less than $12,000 or if you are married and you and your spouse bring in less than $16,000, on that little card will be $600 of value you can use each year right off the top. In other words, you not only get a drug discount, but you will get an additional subsidy to help offset the cost of those medicines. A senior asks me, How am I going to benefit? You take care of the details up in Washington, and do it right. But how is it going to benefit me? Second, beginning in the year 2006, all seniors and individuals with disabilities covered by Medicare will be offered comprehensive prescription drug coverage. They will have access to a plan that offers more comprehensive coverage, when they ask how it is going to benefit them in the future. Third--and this is what I am most excited about in the entire bill-- we have also taken steps to offer seniors and that next generation of seniors a strengthened and improved overall Medicare Program. Seniors will have new choices they don't have now to get better coverage that meets their individual needs. They will be able to choose the type of coverage that best suits their needs. They get immediate help, and we do it in a way with a benefit they don't have access to today, and, in addition to that, we expand choice. They will have an opportunity to choose a plan that better meets their needs. This is an exciting improvement in the Medicare Program which really brings it up to a modern type of health care delivery similar to--not exactly but similar to--the options we have as Federal employees and that I have as a Member of the Congress. It used to be ``Mediscare.'' The last time we tried, 2 or 3 years ago, it was ``Mediscare.'' They said, ``Don't change.'' People will try to force you into HMOs. Do not trust Government. They are going to strip things away from you. Actually the President mentioned this in a bipartisan meeting with Senators yesterday. It is no longer ``Mediscare,'' thank goodness. It is Medicare. That is really what we are trying to do in a bipartisan way. People say, You want to have your choice of doctors and not be forced into HMOs. That is simply not true. In this bill, if you want to--for seniors listening to me--you can keep exactly what you have today in terms of your traditional Medicare coverage. You don't have to do anything to take advantage of the best choices. You can keep exactly what you have today. If you stick with what you have, you can get the prescription drug benefit along with everybody else, if you want to. In other words, keep what you have but take advantage of only prescription drugs. But if you are dissatisfied with your coverage today--and you realize that Medicare really doesn't cover preventive care, it covers very little in the way of chronic disease and management, it does not today, except Medicare+Choice, an organized, coordinated way of getting your health care--you don't have to, but you will be able to choose the expanded, the more flexible, and the more coordinated kind of coverage that today we clearly have as Federal employees and which also most working people have today, that sort of coordinated care plan. But in Medicare today, you don't have that option. You will have the option to get things that are not currently covered by Medicare, such as preventive care. I mentioned the programs of chronic disease management. There are also programs that promote wellness. Annual physical exams we know are so important. Again, whether it is annual or every 18 months, it probably doesn't matter that much. But right now, it is not covered under Medicare. That would be covered in the new program. You will be able to have a nurse call you or stay in touch with chronic disease management to remind you in case you have forgotten about who it is taking your weight or checking your blood pressure or looking for fluid retention and blood pressure, all of which are important. If you pick those up early, it keeps you from being hospitalized or getting sick. That heart is beating. If fluid is building up in your lungs, the heart beats harder and harder. You will have to be admitted to the hospital, and you will be trying to catch up. If they pick it up earlier and you stay healthy through appropriate management, you will not have to be hospitalized. These are the kinds of coordinated benefits most working people have today and, as I mentioned, which Federal employees have today. It is the sort of benefit we want to make available--not forcing people but making it available to seniors as well. Our goal in this bill is to allow you to have options so you can choose the kind of coverage and the kinds of doctors and hospitals that are most consistent with your needs. That is our goal, to make sure those choices are available for you. In the days to come, we will have a lot of discussion and amendments as to how this plan will evolve. That is the whole purpose of having the debate and amendments. As all of us know, the House of Representatives is going full steam ahead doing exactly the same thing we are doing and developing a plan, after which we will go to conference. This bill represents the largest expansion of the Medicare Program in its history. We are going to be spending an additional $400 billion, which is a hefty sum, in providing this new benefit and strengthening the Medicare Program, and $400 billion is a lot. But the fact is that seniors over the next 10 years are going to be spending about $2 trillion on medicines and prescription drugs. We are trying to target the resources of $400 billion in a way that makes the most sense so we can have appropriate benefits for seniors who are less well off and seniors who have very high drug costs so they get the most help. I am looking forward to the debate. I want America's seniors to be able to come back to this picture I have just painted, and I want them to understand really these three things. No. 1, if you want to, you can stick with what you have. No. 2, you can, if you want to, stick with what you have but also get help with your prescription drugs. And, No. 3, you will have for the first time in our Medicare Program the option, the opportunity of choosing a comprehensive, coordinated health care plan that keeps up with medical advances, with advances in technology and with advances in health care delivery systems. When we finish this bill, and when we are successful, you will have a plan that offers real health security. Madam President, I yield the floor.

Mr. FRIST

Mr. FRIST. Mr. President, the amendment I send to the desk is sent on behalf of Senators Cochran and Breaux. It addresses an issue that we have addressed on the Senate floor this evening. It has to do with the safety aspects of the underlying Dorgan amendment. As everyone in the Chamber knows, we have spent the last several days addressing the important issue of adding prescription drugs as a benefit to our Medicare Program today and at the same time strengthening and improving Medicare. Just a few minutes ago, the Senate passed legislation that will speed access of generics to the market, really making drugs overall, I believe, more affordable and more accessible to all Americans. This merely builds on the rule announced last week by the administration that will enhance the overall process with generic drugs by limiting brand drug manufacturers to only one 30-month stay. But in the midst of the overall bipartisan progress to enhance access to and improve the affordability of prescription drugs, once again this proposal or proposals to look at importation of drugs from Canada have resurfaced. Very briefly, the Senate has debated this issue several times before. The legislation itself is already on the books. Congress passed, this body passed, indeed President Clinton signed into law the Medicine Equity and Drug Safety Act of 2000, which allows for the importation of pharmaceuticals into the United States. However, the law provided that the Secretary of Health and Human Services had to demonstrate that its implementation, No. 1, would impose no risk to the public's health and safety; No. 2, would result in significant reduction in the cost of covered products to the American consumer. Since that time, two Health and Human Services Secretaries, one a Democrat and one a Republican, could not demonstrate safety or cost savings from importation. I reiterate, the law on the books is such that safety concerns have been expressed and, indeed, two HHS Secretaries could not demonstrate safety or cost savings from importation; therefore, the law has not been implemented. In addition, the FDA, two separate Secretaries of Health and Human Services, the U.S. Customs Service, the Drug Enforcement Administration, and almost every former FDA Commissioner have consistently and repeatedly opposed these proposals and told us they cannot ensure that importing drugs is safe. I ask unanimous consent to have printed in the Record a letter dated June 19 to Senator Cochran from Mark B. McClellan, Commissioner of Food and Drugs.

Mr. FRIST. I will read two sentences from the letter, the entire text of which will be in the Record. It says in the first paragraph: The FDA has serious concerns about proposals that would open America's borders to a stream of imported prescription drugs for which FDA cannot assure safety, effectiveness or quality. In the last paragraph, one other sentence: I remain concerned that provisions to legalize importation of prescription drug products would greatly erode the ability of the FDA to ensure the safety and efficacy of the drug supply. One final point: Canadian health officials just very recently made it clear that they cannot, and they indeed will not, vouch for the safety of prescription drugs imported from Canada to the United States. Thus, I would argue that there is no need for Congress to pass yet another piece of legislation when a law is already on the books, and doing so only further threatens the safety of the American public, particularly in this time of sensitivity to the dangers of possible biological, chemical, or other terrorist attacks. Relying on medicines that have been imported from other countries, if that were the case, I believe would lead to seniors and individuals with disabilities opening themselves to unnecessary threats in particular, especially in light of the current bill, where we are giving them access to prescription drugs they simply did not have before. Obtaining drugs from other countries has a certain appeal to seniors who simply have no access to any prescription drugs at all, but the underlying premise of the bill on the Senate floor is that we are going to improve that access to each and every senior, in terms of having better access to those prescription drugs. I yield the floor.

Mr. FRIST. I ask unanimous consent the reading of the amendment be dispensed with.

Mr. FRIST

Mr. FRIST. Again, all of this demonstrates that everybody is working as hard as they can to address this situation in a reasonable, step-by- step fashion. So I am very pleased with where we are today. Both sides are very anxious to begin the amendment process, which is very good because all too often people push their amendments off until the last minute and we have many amendments flowing. In this particular case, we have encouraged people to come forward and let the managers know what amendments they plan to offer and then talk about the amendments so they can adequately plan. Indeed, that is under way. I yield the floor.

Mr. FRIST. Mr. President, that is generally my understanding. Again, for our colleagues, in order for the process to start and to allow us to really begin the amendment process, we have to have what is called a scoring from CBO. We were in touch with them at 8:30 and 9 this morning. It is my understanding we will have that scoring, but before I can say anything further with absolute certainty, we will know something in the next 30 minutes or so. Once we get that scoring that is both in the aggregate but also line by line--and we did not have a line by line at 7 this morning, and people are working around the clock on it, but once we have that line by line, we will be able to go directly to the managers' package and then also directly to the amendments. I am very hopeful that at 10 this morning that process will start.

Mr. FRIST

Mr. FRIST. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. FRIST. Mr. President, I wish to take a few minutes to address the Prescription Drug and Medicare Improvement Act of 2003 in a very basic way, and that is to answer some of the questions I have received over the last several days since we have captured much of the attention both of the media as well as constituents around the country who realize we really are going to pass very significant, very important legislation that will affect their lives, that will affect the lives of seniors, individuals with disabilities, and that will affect the lives of future generations. And this will happen in the next 12 to 13 days. It goes back to the question of, Do we really need to change? Are things really that different that they demand the sort of response we are putting forward where we talk about strengthening and improving the Medicare Program overall and at the same time providing prescription drug coverage for seniors and individuals with disabilities that is not being provided today, and do it in a way that can be sustained over time, recognizing that we will have a huge demographic shift of seniors over the next 30 years as a product of the baby boom following World War II. That fertility curve, that baby boom moving through the system begins to hit about 2007, 2008. That is when the curve moves through. For the next 25 years after that, we will see this huge explosive growth in the number of seniors with fewer and fewer workers actually paying into the system. We have now been on the bill Monday, Tuesday, and Wednesday, after having over 30 hearings on Medicare over the last several years and several hearings this year specifically on prescription drugs and Medicare modernization in the Finance Committee. We have done it in a very systematic way, in a bipartisan way that I think captures the very best of what this institution is all about, recognizing that we do not know all of the answers, we cannot cure all of the problems. We have to be very careful not to overpromise because everybody wants as much health care resources as possible, so we cannot overpromise. As I say, we need to reform the system in a way that does not just respond to the needs of today but responds to the next year, 5 years from now and 10 years from now. Since we cannot do it perfectly now, we have to do it in a way so that the system is flexible and allows us to adapt appropriately. Working on a bipartisan basis, the goal is to deliver a secure Medicare Program that is comprehensive and, at the same time, offers maximum choice with that increased flexibility and that much-needed prescription drug coverage which seniors do not have today through the Medicare Program. I look forward to the continued debate over the next 10, 11 days on how we collectively determine how best to accomplish those goals. I am confident we will be able to cull the very best ideas from both sides of the aisle to pass a responsible and effective plan. As I mentioned, I want to limit my comments today to about how medicine, science, and health care delivery has evolved and, indeed, how that evolution, which has been very rapid in terms of breakthroughs in science, which I have been privileged to watch and participate in as I was in the field of medicine for 20 years before coming to the Senate--it has been miraculous in so many ways. When I close my eyes, I see my patients with artificial hearts I had the privilege of implanting, and with the heart transplants I was blessed to do on a weekly basis or even more often. I was involved in not the whole period since 1965 when Medicare began, but shortly thereafter, I was in the active practice of clinical medicine over that period of time. If we just look at the last 10 years, life expectancy has increased by around 2 to 3 years, and if we look at the last 40 years, going back to about 1960, life expectancy increased 10 years in that period of time since Medicare was begun. Death rates from heart disease have been cut in about half over the period since Medicare began. Heart disease happens to be the field in which I specialized. If we look at the field of cancer, whether it is prostate cancer, breast cancer, or colon cancer, because of new treatments, new medicines, and new diagnostic tools, we have seen markedly increased patient survival rates. At the same time, we have seen these great medical breakthroughs in the health care delivery system, the private health care delivery system--not Medicare--but the private health care delivery system has evolved and has responded. The problem is that the underlying Medicare system itself has not evolved. In fact, there has been very little change in the Medicare system since 1965. So we have all these great medical advances and advances in health care delivery over time which has skyrocketed, with improved advances throughout, but we have a Medicare system that has changed very little. It is this gap, this difference between the great breakthroughs in medicine, science, and health care delivery and the pretty much nonchanging Medicare system. That gap is what we are attempting to fill, to respond to as we go forward. Medicare was designed to respond to an acute illness. Let's say you are healthy and all of a sudden you have a heart attack and you have a good response to that heart attack in hospital treatment, and it worked pretty well as long as that was what health care delivery was. Today, the situation has changed markedly. Preventive medicine today is exponentially more important than in 1965. Why? Because we understand how to prevent disease, how to maintain health. In 1965, we did not fully understand the nature of the science of preventive medicine. It simply was not developed in 1965 to the degree it is today. Yet we have a Medicare system which has--I came close to saying almost no preventive care is provided in Medicare today. That is a little bit of an overexaggeration because we have to legislate that, yes, Medicare does cover mammography. Almost every one of these procedures has to be legislated, and with so many advances coming through quickly, we cannot keep up. There is very little preventive care in Medicare today. Yet we all know how important it is if we look at managing one's health today, maximizing one's health. In the 1970s, health care responded to acute episodic illnesses. Today it is preventive health care, maintaining wellness, management of chronic disease on an outpatient basis, using medicines, but Medicare has not changed very much. I will give a couple of examples. Again, the goal is health care security for seniors. If you see a senior, you want to be able to say: The Government is helping you with health care security, and health care security means we have to include prescription drugs. I mentioned Medicare lacks good preventive coverage. It also lacks the wellness care in chronic disease management. For example, Medicare does not cover cholesterol screening. If we look at heart disease, cholesterol is important. Yet Medicare does not cover cholesterol screening. Medicare does not cover an annual physical examination today. I do not know if it has to be every year or every 18 months, but the point is, systematic regular examinations, if you are going to pick up that cancer when it is small or that heart disease before it becomes a massive heart attack, you can do it through annual physical exams, but they are not covered under Medicare. Medicare does not protect at the extreme end, what we call catastrophic. That means if you are sick enough, if you have a lot of out-of-pocket expenditures, Medicare has no limit to that. Today if you have a catastrophic illness, there is no upper limit. A lot of people do not realize that. The one issue we talk a lot about, because it is probably most dramatic, is that Medicare does not at all cover outpatient prescription drugs. Thus, we have gaps in coverage for seniors. We are promising them health care security which they deserve, and yet we have these huge gaps in coverage which have been created since 1965. It is our obligation, our responsibility to respond, and, thus, over the next 12 days we will be putting together a bipartisan plan--though we do not know all the answers--we will be putting together the very best of what we do know to respond to these needs. Today, on average--and a lot of people do not understand, or they were not aware of this, so it is important for us to keep saying it-- Medicare covers right at about half of what a senior's medical care expenses are. Most think it covers 80 or 90 percent. If one is not yet a senior, it is important for them to know what their Government is doing for them now is to cover only about half of the expenses. Again, most people are not aware of that. The response to that is that seniors and individuals with disabilities try to fill those gaps on their own, sometimes successfully, and many times not. They try to do it through Medicaid. They try to do it through private supplemental insurance programs, only to find that they are hit with these skyrocketing premiums that are growing 10, 15, 20 percent a year at this point. Or they find that their employer on whom they were depending is scaling back on the benefits that they once had when they were working full time. I say all of this because it is important for people to understand why we are aggressively moving ahead in the way we are to develop a strengthened and improved Medicare plan. I mentioned the lack of prescription drugs. If we look at aging, our population over the age of 65, we know prescription drugs become even more important than they are under 65 years of age or under 50 years of age or under 45 years of age, and that is new. It is really within the last 30 years that these medicines have become so important. Thus, it is our obligation to strengthen and improve access to prescription drugs. I have had the privilege to observe a lot of this as a physician, and I will give a couple of examples. Over the past 3 decades--remember, Medicare started in 1965--the death rate from hardening of the arteries, or atherosclerosis, the underlying pathology within the heart, has declined by 74 percent. Deaths from ischemic heart disease-- ischemic is low blood flow where the heart is not getting enough oxygen and blood, and that is what causes a heart attack, hardening of the arteries, myocardial infarction, heart attack--death rates have fallen over the last 30 years by 60 percent. People ask why. There are lots of reasons, but I would say one of the major reasons is medicines today, that we are treating high blood pressure earlier; we are treating congestive heart failure earlier before these deaths from ischemic and other heart disease occur. Medicines that were not around 30 years ago are the beta blockers. It actually makes the heart so it does not beat so hard. If it is not beating so hard, it does not consume as much energy and does not need as much oxygen. Therefore, low blood flow to the heart does okay. Other drugs called ACE, A-C-E, inhibitors, the medicines, in large part, have explained this increasing survival fall in mortality. Over the last 30 years since Medicare began, death rates from emphysema, or lung disease--a type of lung disease called chronic obstructive pulmonary disease, emphysema, is one of those two types-- have fallen by 60 percent in large part because of the use of anti- inflammatory medications--they decrease the inflammation in the lungs-- and also a group of drugs call bronchodilators, which dilate those little bronchial air waves in the lung. The point is, it is these medicines that in large part explain this improved health and the improved treatment of emphysema. I have a couple of books with which I wanted to illustrate my point. Nearly 400 lifesaving drugs have been produced in the last 10 years. Meanwhile, there are over 600 medicines under development right now by the Nation's pharmaceutical research companies to treat diabetes, heart disease, cancer, stroke, and peripheral vascular disease. I mentioned these books. This is called the PDR, the Physicians' Desk Reference, for pharmaceutical specialities and biologicals for the physician's desk. Every physician in the country uses this on a regular basis because it allows them to look up individual medicines. It gives the descriptions, the side effects, and the contraindications. No matter how smart one is or how much time one spends with it, there is no way to remember all of these drugs or everything in the book, although some people may be able to. The point is, this book was printed in 1965. This is the year Medicare was actually passed and then implemented. That was over 30 years ago. Again, this book has 1,060 pages in it. The type is pretty small. It is just medicine after medicine. When I see this, I am kind of glad I do not have to know all of that right now because there is so much in it. This PDR is the 57th edition, and this one is from 2003. It is pretty interesting to me because this first book is when Medicare started, and this other book is where we are today. Today's book is a little bigger but is a lot thicker, and instead of having 1,060 pages in it--these are not all lifesaving drugs but all drugs which have a real importance in terms of treating and quality of life--this book has 3,500 pages in it. I wish I could show this to the Chair, but the type in this new book is about half the size of the type in the old book. So the truth is, it is about 6,000 pages. The point is, medicines make a difference. They made a difference in 1965. They really make a difference today. Seniors do not have access to these through our Medicare system in either case. Great advances, and our Medicare system has not changed. It does not recognize that as we go forward. That is why we are here. I want to make this case of why we are here and why this is so important today that the health care system, the delivery system, has markedly improved with great scientific advances, and Medicare is not capturing it today. Our seniors deserve for those to be captured. Next month does mark the 38th anniversary of the launch of Medicare. On July 30, 1965, President Johnson traveled to Independence, MO, to sign the bill into law. President Truman, who had initiated the drive for health care security for seniors about 20 years earlier, was on hand to receive that first Medicare card. President Johnson, upon signing that historic legislation, told the assembled lawmakers in 1965: The benefits under the law are as varied and broad as the marvelous modern medicine itself. No longer will older Americans be denied the healing miracle of modern medicine. No longer will illness crush and destroy the savings that they have so carefully put away over a lifetime so that they might enjoy dignity in their later years. No longer will young families see their own incomes, and their own hopes, eaten away simply because they are carrying out their deep moral obligations to their parents . . . Nearly 40 years later, we have an opportunity to realize this noble vision. Before the end of next week, the Senate will have the opportunity to pass legislation that does provide prescription drug coverage for our seniors, that does protect seniors and gives them health care security by giving them greater choices so that they can choose the health care coverage that best meets their individual needs. I believe future generations will judge us by the choices we make over the next several days and at the end of next week, whether we chose to act responsibly, recognizing our obligations to strengthen and improve the system, or whether we chose just to talk about it, the same rhetoric, something that we should do. My position is clear; now is the time to act. I am delighted we are acting in a bipartisan way. Now is the time not just to tinker and play around the edges, but it is time to truly transform the system. We have a responsibility to provide our seniors with a system that works, that indeed gives them health care security, and now is our opportunity to deliver it. It will require us to focus on the big picture. It will require us to focus on the future. It will require us to focus on our fellow citizens, whom we are so privileged to represent.

Mr. FRIST

Mr. FRIST. Reserving the right to object, my understanding is it would be for debate only until the managers come back to the Chamber. May we have a general understanding that this is for debate only until the managers come?

Mr. FRIST. Mr. President, reserving the right to object.