Ted Kennedy

Mr. KENNEDY

Mr. KENNEDY. I move to reconsider the vote.

Mr. KENNEDY. Mr. President, throughout this debate we have heard the same tired old refrain. It is the same refrain we hear whenever we confront a powerful vested interest on behalf of the American people: Costs will go through the roof; people will lose their jobs or their health insurance; gloom and doom will envelop the Nation. We heard it on the minimum wage. We heard it on the family and medical leave bill. We heard it on the Kennedy-Kassebaum insurance reform bill. Every time the special interests launched a massive disinformation campaign, and every time they were wrong. Six hundred organizations of doctors, nurses, patients, from the American Medical Association to the American Nurses Association to the American Cancer Society, support our bill--virtually the entire medical and patient community. Do the opponents really expect the American people to believe that doctors, nurses, and patients would support legislation that would cause people to lose their insurance? Do they? We heard an eloquent statement this morning from Senator Zell Miller. All these claims were made in Georgia and all of them proved to be false. I hope we can move beyond these false charges and get back to the business of protecting patients. On this amendment, I support providing full deductibility for the self-employed. This can pass the Senate any time. It has passed the Senate before. But on this bill, it is a poison pill. It kills the bill. Anyone who votes for this amendment is voting against patient protections. I urge its rejection. During the course of the afternoon, we heard those on the other side talking about the importance of the premium. It was pointed out that the increase over 5 years will be 4.2 percent, a little less than under the bill of the President, which is 2.9, a point difference. Look what the CEO of United Health Group received last year: $54 million in annual compensation and $357 million in stock options. That particular payment amounts to $4.31 a month. Ours is $1.19 a month. If you want to do something, there are 7 million employees here. This one individual raises the cost of the premium by $4.13. Ours, in order to protect and grant greater patient protections, is $1.19. Let's get serious about these facts. Let's get serious about the figures. Let's not just read the HMO script sheets. Let's debate the real issues and protect American patients.

Mr. KENNEDY. If I could have 15 seconds of my own time, that is not what CBO or OMB have said. In fact, in specifically studying the costs of this, they have indicated, where you are going to have these kinds of protections, you might have greater numbers of people covered, rather than less. Now, you may be able to find some economist someplace who can cook some numbers, but according to OMB and CBO--which we use around here-- they do not support the Senator's statement.

Mr. KENNEDY. Not CBO.

Mr. KENNEDY. I yield myself 1\1/2\ minutes. You say with the increased costs there is an increasing number of people who will lose their health insurance. Last year there was a 9-percent increase in premiums. I would like to ask the Senator: Where was the decrease in the number of the uninsured? To the contrary, the figures show there are more people who are uninsured. So I have difficulty in accepting that. This year the HMOs have already said the premiums are going up 10 percent, even without this. So under that assumption, that would mean 5 million more people who will be uninsured. There were 4 million last year; 5 million now. I do not see where the facts are to support your position.

Mr. KENNEDY. I listened to the Senator talk about the increased costs and how that would translate----

Mr. KENNEDY. No, just for a question.

Mr. KENNEDY. Will the Senator yield for a question?

Mr. KENNEDY. Does the Senator not find this somewhat disingenuous that the administration had made the recommendation on the Durbin amendment for the business community, for the self-employed, and these Republicans dropped it, put it aside; they didn't make it a priority for their tax break? The administration came up with $60 billion to try to help the uncovered with insurance, and they dropped that. And now two of the principal reasons they give from this side are that they are not taking care of business and they are not taking care of the uninsured. I mean, if this was such a big priority on their side, why didn't they fight for it when they had the opportunity? Does that not lead one to believe that rather than being serious about getting these achievements and providing some relief, they basically want to sink this bill?

Mr. KENNEDY. How much time does he have left?

Mr. KENNEDY. Will the Senator yield for a question?

Mr. KENNEDY. I yield 10 minutes to the Senator.

Mr. KENNEDY. Yes. While the Senator was asking, we never received the Hutchinson amendment until it was offered either. As we proceed, what we would like to try to do, for the benefit of the Members, is to at least have the two or three amendments on either side so that the Members are familiar with the material and would have knowledge as to what those amendments are. I think that might save a good deal of time in terms of the explanation of the amendments and the disposition of them. We will make every effort to make those available. And we hope-- if I may have the Senator's attention--that that would be reciprocal and we might have the amendment you also intend to offer tomorrow.

Mr. KENNEDY. Mr. President, I ask unanimous consent that the time on the pending amendment prior to a vote in relation to the amendment at 5:30 be divided as follows: Senator Kennedy or his designee to control 30 minutes of debate; Senator Hutchinson or his designee to control the remaining time, including the last 15 minutes prior to the vote; that at 5:30 the Senate vote in relation to the Hutchinson amendment; that upon completion of the vote at 5:30, Senator McCain be recognized to offer a sense-of-the-Senate amendment regarding clinical trials; the amendment be debated this evening; and then when the Senate resumes consideration of the bill tomorrow at 9:30, the time prior to 11 a.m. be divided between Senator McCain and Senator Gregg or their designees; and then a vote in relation to the McCain amendment occur at 11 a.m.; and then following the disposition of the McCain amendment, Senator Gregg or his designee be recognized to offer an amendment; that no second-degree amendments be in order to either the Hutchinson or McCain amendments.

Mr. KENNEDY. Mr. President, in response to the Senator from Oklahoma, we have been assured, from the Budget Committee, the Finance Committee, and the Ways and Means Committee, that there is no blue slip problem. Anyone can raise this and challenge those authorities, and maybe they will. At least we want to give assurances to the membership that we did anticipate this issue. We have received those assurances from the leaders. I believe we received them in a bipartisan way as well.

Mr. KENNEDY

Mr. KENNEDY. Mr. President, a number of our colleagues want to address the Senate. So I will speak briefly this afternoon. I want to come back to one of the provisions I believe is so important in our legislation. I don't think there really should be any doubt about our strong commitment in the Senate to protecting American patients on the issue of clinical trials. As I mentioned earlier when I had a brief exchange with my friend and colleague from North Carolina, I think any Patients' Bill of Rights that is going to be worthy of its name is going to provide good protection for clinical trials. As I have mentioned on other occasions, we have seen a vast expansion of basic research and commitment by this body. We have doubled the NIH budget in recent times. Recently we have witnessed the mapping of the human genome and the sequencing of genes. Rarely does a day go by when we don't hear on radio, see on television, or read in the newspapers about some new kind of medical breakthrough. These breakthroughs can make a very important difference in the quality of health and life for American patients. Our whole biotech industry has been increasingly effective at making progress in areas which we could not have possibly have imagined. It is true with the orphan drug program, which we intend to reauthorize this year. On just about every front, we have seen the most remarkable progress. But in order for that progress to take life, we have to see the progress made in the laboratory get to the patient. The key aspect of this transition is clinical trials. We believe clinical trials offer enormous hope for thousands of our fellow citizens. What we have seen in recent times is that one of the most serious abuses by HMOs is the denial to participate in clinical trials. Had these patients been involved in clinical trials, in many instances their lives would have been saved. This has been commented on by our colleagues. Their lives would have been greatly enhanced if they had been able to participate in these clinical trials. I still remember very clearly the testimony we had before our HELP Committee on this issue a number of months ago. We had the director of the Lombardi Center, named after the great football coach, here in Washington. We asked him about what their principal challenges were as a research center. He said they had hired a number of people, and the people they hired were professionals. However, what they were hiring them for was to wrestle with the insurance companies to permit those individuals who ought to be included in the clinical trials to be so included. They had seen a significant expansion of that--far too many. He said they could have used those resources for additional kinds of trials and benefits for consumers. But he gave so many different examples of people whose lives were basically diminished and, in many instances, lost because of the failure of inclusion. In the provisions of the McCain-Edwards bill, there are protections which are routine in terms of clinical trials that must be followed. In order to participate, there has to be the prospect that the individual can make progress, and the patient also has to meet other kinds of basic requirements. The last time we debated this issue on a Patients' Bill of Rights, the Senate finally accepted a study on whether clinical trials were really useful, productive, or helpful for American patients. It is difficult for me to believe that was the final resolution for this body, but it was. What concerns me greatly is the issue of how we are going to eventually resolve this issue. Recently, the Medicare Program has expanded their clinical trials program. They had to deal with a number of issues. They had to deal with unanticipated patient care costs as a result of participation in the clinical trials. They had to deal with a number of these matters. It is interesting to note that the alternative proposal from Senator Frist and Senator Breaux has a clinical trial provision, but their provision will substantially delay implementation. A fair review of their provision reveals the clinical trials would not go into place for probably 4 or 5 years and also their bill excludes unanticipated patient care costs as a result of participation in clinical trials. The reason they delay implementation is they want a further study on the allocation of costs between the clinical trials and the insurance companies. The fact is, that study has already been done. That review has already been made. The facts are in and they have been examined, reexamined, and examined again. They are being implemented at the present time and are virtually unchallenged. We have to ask ourselves why we should have a whole other additional process that is going to delay clinical trials under the proposal of our colleagues. I have not heard the justification or the rationale for that. Also, the alternative to the McCain-Edwards proposal excludes the FDA clinical trials. That, I understand, is directly as a result of the request of the insurance industry. That does raise important questions because the FDA reviews are some of the most advanced reviews, some of the most important reviews, and some of the trials are at the edge of potential benefit to consumers. Yet they are completely excluded. They are included in our proposal because we value those important clinical trials. This provision of clinical trials may not seem as important, but if one asks the breast cancer coalition in this country about what is extremely important in the protections of women and the treatment of women, they will mention clinical trials. If one talks about other dangers of cancer, by and large, the issue of clinical trials will be at the top of their list, a top priority, a top patient protection, and we believe in that. We share that view. This is something that is absolutely essential if we are going to move ahead with the protections of patients. We have done that previously. We have seen how there had been an allocation of resources historically between the insurance companies when they covered patients and the trial itself as a general understanding, as I mentioned, under Medicare, about those allocations of resources, what should be allocated for the clinical trial and expenses associated with that, and also what would be allocated by the continuation of care which the HMO would be otherwise required to pay. One of the loopholes that has been added to this is the issue about some reaction to the clinical trial that may be related to the illness or not, say, someone going in under a cancer protocol and then having some kind of adverse reaction as to make their situation more complicated. Yes, that may happen in certain circumstances, but it does seem to me we ought to address that. We have done that in the past. There is no reason we should not. That has not presented itself as an impediment to moving ahead on this issue. We ought to be able to get that behind us. I am strongly committed to ensuring that whatever comes out of this body in terms of the Patients' Bill of Rights has these protections. I might mention a note from the Cancer Society: On behalf of the American Cancer Society and its 28 million supporters, I am writing to respectfully request that you allow debate on the Patients' Bill of Rights to move forward and that you support the ``Bipartisan Patient Protection Act of 2001.'' As the largest voluntary health organization dedicated to improving cancer care, the Society has set the enactment of a patients' bill of rights that provides strong, comprehensive protections to all patients in managed care plans as one of its top legislative priorities for this session of Congress. While the Society does not have a position on health plan liability, we have identified several other provisions that are critical to cancer patients. This is what it is, Mr. President. We are concerned about what is critical to cancer patients in this country. It is spelled out here. I will take a few moments to mention them. Specifically, we advocate the patient protection legislation that provides all insurance patients with: Increased access to clinical trials--assuring that cancer patients who need access to the often life-saving treatments provided in both federally and privately-funded or approved high-quality, peer-reviewed clinical trials have the same coverage for routine patient care costs (e.g., physician visits, blood work, etc.) as patients receiving standard care. Prompt and direct access to the medical specialists. Patients facing serious or life threatening illnesses, such as cancer, need continuity of care-- This legislation provides it-- the option of designating their specialist as their primary care provider-- This legislation provides it-- and the ability to have a standing referral to their specialist for ongoing care. Our legislation provides it. Strong, independent, and timely external grievance and appeals procedures. Our legislation provides it. Mr. President, the letter continues: We are particularly pleased that-- McCain-Edwards-- includes a strong clinical trials provision that provides access for cancer patients and others with serious and life threatening diseases to both federally and privately- sponsored high-quality, peer-reviewed trials. The FDA trials as well as other trials. Clinical trials are a critical treatment option for cancer patients and are also essential in our nation's efforts to win the War Against Cancer. Without clinical trials, new or improved treatments would languish in the laboratory, never reaching the patients who need them. Unfortunately, only three percent of cancer patients currently enroll in clinical trials. Part of the problem is that many health insurers refuse coverage for a patient's routine care costs if the patient enrolls in a clinical trial--effectively denying access to life-saving treatment. We are interested in dealing with the challenges of cancer in our society, which is the top killer and the one that is most dreaded. I remember a great leader in the Senate, Warren Magnuson. He was instrumental in setting up the National Institutes of Health, and strongly supported the Cancer Institute. He said his dream of a newspaper headline was ``Cancer Conquered.'' That is something most Americans agree would be the best possible headline. Clinical trials are indispensable. Nineteen percent of the children who have cancers are involved in clinical trials. We have had the greatest progress and breakthroughs in the area of children's cancers. Researchers say a very significant reason for that is because of their involvement in clinical trials. We have made slower progress dealing with other cancers, and we have reduced numbers of people included in those trials.

Mr. KENNEDY. Madam President, I just want to say at the outset of this debate that this is not a new legislative proposal. We have had very extensive debates on the provisions which are included in the Patients' Bill of Rights. We have had good debates on the provisions when we passed the Frist bill about 2 years ago. And we had additional kinds of debates when we took up the Norwood-Dingell bill a little over a year ago. These matters have been before the Senate. They are matters that have been discussed repeatedly in this Chamber by a number of us over a very considerable period of time. We want to point out at the outset of this debate, that the kinds of alterations, adjustments and changes that were made over the weekend were basically technical in nature. I went through those yesterday with the Senator from North Carolina. Maybe later in the day, if it is necessary, I might go through them again. But again, they were basically clarifications in response to questions that were raised about different language interpretations of the bill. These were issues that have been raised by the White House, and those who were opposed to the legislation. I think the most recent changes help clarify the language in our bill. As we have said all along, we are always interested in hearing ideas, suggestions and recommendations, as long as they are consistent with the fundamental purpose of the legislation. Our purpose is protecting patients, and also assuring accountability by HMOs and insurance companies that are making medical decisions and, too often, overruling doctors, nurses, and trained personnel. So I know there are some concerns. But the way to deal with those kinds of concerns is to engage in debate on these issues. I think if you look at the Frist bill, you will find that it tracks, at least in titles, the Norwood-Dingell and the McCain-Edwards legislation. However, the Frist bill creates numerous loopholes, which I think fails to respond either to the President's desire to make sure that all Americans are covered. We will have a chance during the day to point out some of those differences between their bill and ours. We are facing a situation where there are many of us, a majority in the Senate, who are in strong support of the McCain-Edwards legislation. On the other side there are those who don't want any legislation and a small group who prefer the Frist-Jeffords-Breaux provision. We will work our way through it. That is the way the Senate functions. We welcome the opportunity. I note the presence of my friend and colleague, Senator Edwards. He and I plan to be here the whole day. We are in the Chamber ready to deal with either amendments or to try to clarify provisions for those Members who fail to understand them. We are also here to point out, in the case of Breaux-Frist, how we think the McCain-Edwards bill provides better protections for American families. We are glad to do that as well. That is the framework. We are starting out on day 2. We are glad this bill is before the Senate, even though we will wait until tomorrow for the first amendments. I am heartened by the strong resolution of our leader, Senator Daschle, in committing us to the conclusion of this legislation prior to the Fourth of July recess. Americans have waited too long. They have waited over 5 years for a strong, enforceable Patients' Bill of Rights. This issue has been studied and studied to death. It is time for action. The Senate's failure to take action results in too many of our citizens--too many children, too many women, too many seniors, too many families--being harmed today and experiencing additional kinds of pain and suffering. It is within that framework that we will hopefully move ahead today. It is time to pass the Patient Protection Act. Every doctor knows it. Every nurse knows it. Every patient knows it. The American people know it. And in their heart, every Senator knows it, too. Often today managed care is mismanaged care. It is long past time for Congress to act to end the abuses by the HMOs. Too often insurance company accountants are making the medical decisions instead of doctors and patients. It is long past time for Congress to assure that the medical care is based on a patient's vital signs, not an insurance company's bottom line. The first proposal to do so was introduced in early 1997. We are now in the fifth year of consideration of this essential reform. Patients are still suffering, even dying, because of our inaction. Every day the Congress fails to act, an intolerable additional cost is imposed on patients and their families. A survey by the School of Public Health at the University of California found that each and every day, 50,000 patients go through added pain and suffering because of the actions of their health plan, 35,000 patients have needed care that is delayed or denied, 35,000 patients have a referral delayed or denied, 31,000 patients are forced to change doctors, and 18,000 patients are forced to change medications. A survey of physicians by the Kaiser Family Foundation and the Harvard School of Public Health found similar results. Every day, tens of thousands of patients suffer serious declines in their health as a result of the action or inaction of their health plan. Whether the issue is diagnostic tests, specialty care, emergency room care, access to clinical trials, availability of needed drugs, protection of doctors who give patients their best advice, or women's ability to obtain gynecological services, too often HMOs and managed care plans put profits ahead of patients. The issue is clear: Does the Senate stand with powerful HMOs or with American families? Do we stand for protecting patients and their doctors or protecting insurance company profits? There is only one reason this legislation did not pass years ago. It is because of the tens of millions of dollars the insurance companies and their allies have lavished on lobbying, campaign contributions, and misleading advertising. Now is the time to say that the health of every American family is a public trust, not a commodity for sale to the highest bidder. The need for prompt action on patient protections is great because the dishonor roll of those victimized by HMO abuses is so long and growing. A baby loses his hands and feet after a medical emergency because his parents believe they have to take him to a distant hospital emergency room covered by their HMO rather than the hospital closest to their home. A Senate aide suffers a devastating stroke which might have been far milder if her HMO had not refused to send her to an emergency room. Even now, the HMO refuses to pay for her wheelchair. A woman is forced to undergo a mastectomy as an outpatient instead of with a hospital stay as her doctor recommended. She is sent home in pain with tubes still dangling from her body. A doctor is denied future referrals of patients by an HMO under a managed care plan because he has told a patient about an expensive treatment that could save her life. The parents of a child suffering from cancer are told that lifesaving surgery should be performed by an unqualified doctor who happens to be on the plan's list, rather than by a specialist at the local cancer center equipped to perform the operation. A woman with advanced cervical cancer is denied the opportunity to participate in a clinical trial that could save or prolong her life. A child with cystic fibrosis is denied the opportunity for treatment at a center with the expertise to treat the disease. A teenager with a seriously injured hand is told by his insurance company that they will pay for an amputation, but not the more expensive reconstructive surgery that could provide a normal life. A woman with a relatively minor leg injury ends up losing her leg because her insurance company persistently delays and denies adequate care. Our legislation corrects all of these problems and many more. It takes HMOs and insurance company accountants out of the practice of medicine and returns decision making to patients and doctors where it belongs. Our proposal guarantees patients the rights that every honorable insurance company already grants, and it provides an effective and timely means to enforce these rights. These protections are basic aspects of good health care that every family believes they were promised when they purchased health insurance and paid their premiums. Virtually all of the patient protections in this legislation are already available under Medicare. They have been recommended by the National Association of Insurance Commissioners and the President's Advisory Commission. They have also been proposed as voluntary standards by the managed care industry itself through its trade association. In fact, most of them are features of the patient protection legislation enacted under Governor George Bush in Texas. Patients should have the right to see a specialist, if they have a condition serious enough to require specialty care. No parent should be told that their child with cancer has to be treated by an HMO physician who lacks the expertise needed to treat the child effectively. Patients should have the right to the prescription medicine their doctor says they need. They should not be told that they have to settle for the second best medication for their condition or suffer unnecessary side effects or pay more because the most up-to-date drug is not accepted by the HMO. Patients should have the right to go to the nearest hospital when they have symptoms of serious illness. They should have the right to continuing emergency care after their condition is initially stabilized. Medicare patients have these rights, and other Americans should have them, too. Patients should have the right to participate in a clinical trial if it offers the best hope for a cure or improvement of a serious or fatal illness.

Mr. KENNEDY. I am glad to yield for a question.

Mr. KENNEDY. The Senator is quite right about the fact that every day we delay this legislation, thousands of Americans suffer. The California study says that 50,000 Americans a day are suffering as a result of delay or treatment. They would not be suffering if this legislation were passed. And 35,000 families are being turned down by HMOs today for specialty care that they otherwise would have for their children, their parents or another loved one. Close to 20,000 are taking alternative medicines and not taking the prescription drugs that their doctor says are needed but are not on the formulary of the HMO. The HMO only allows patients to take these alternative drugs. In many instances, patients take their alternative drugs and have two or three adverse reactions before they will come back to the drug that is actually prescribed by the doctors. So every day that goes on, American families are suffering. I might mention to the Senator the point made on this chart. This is from the Kaiser Family Foundation and the School of Public Health up at Harvard, July 1999. Doctors know that congressional delays mean patient suffering. This chart indicates the number of doctors each day seeing patients with a serious decline in health from plan abuse. These 14,000 cases represent the number of doctors who every day see denied coverage of recommended prescription drugs. So 14,000 doctors have said they prescribed prescription drugs and they were denied, 10,000 doctors were denied the diagnostic tests that they believe were necessary in order to make an effective evaluation, 7,000 doctors claim they were denied the opportunity for specialty care, and 6,000 were denied overnight hospital stays. And 6,000 were denied referrals for mental health or substance abuse. The list goes on. Those are two very important studies that make a very powerful case regarding how American patients are suffering. An additional study from the doctor's point of view came to a virtually identical conclusion-- that patients are suffering every day as a result of HMO abuses.

Mr. KENNEDY. The Senator is absolutely correct. That is what is happening regarding prescription drugs, and that includes the tests that are necessary and the specialists that are necessary. The point I want to mention here, as the Senator was inquiring, is the importance of patients' rights to participate in a clinical trial. I think this is one of the most important guarantees that should be a part of this legislation. Unfortunately, we had a full debate on this 2 years ago in the Senate, and the Senate rejected ensuring patients access to clinical trials. What we agreed to was a 2-year study of whether clinical trials are effective. That was under the Frist bill that eventually passed this body. I am wondering whether the Senator would agree with me that we are in the time of doubling appropriations for the NIH budget. We are in the century of the life sciences. We can't pick up a newspaper any single day and not see medical breakthroughs. It is one of the most exciting times in medical history, with the progress that has been made on the human genome, the sequencing of genes and the explosion of different knowledge that is out there. We are going to see the development of all of this knowledge now in the laboratories. I ask whether the Senator would not agree with me that in order to get it from the laboratories to the bedside, it has to be tested. It has to have clinical trials. This is a time of enormous potential for reducing the kinds of pain and anxiety that disease and illness bring. We can even reduce the demand on resources over a period of time. We know, for example, that if we were to develop some kind of cure for Alzheimer's, half the nursing home beds in Massachusetts would be empty this afternoon. Half of them would be empty. And there is important progress. But it isn't going to get out there unless we have the clinical trials. Finally, as the Senator understands, insurance companies have over a period of time continued--when a patient needed the clinical trial--the ordinary expenses that were attendant to it. The clinical trial would pick up the additional kinds of expenses. They didn't go to great additional expenses. But even that kind of responsibility is being rejected now by the HMOs. The number of clinical trials is going down and threatening not only the well-being and security of the people who are in those HMOs, but the well-being of the rest of the people in our society.

Mr. KENNEDY. Well, I will. This is enormously important. Let's look at what clinical trials have meant in recent times. We have made the greatest progress in addressing the challenges that children face with cancer. Listen to this. We have 70 percent of children with cancer treated through clinical trials. This is the area where we have seen dramatic progress made. In the last 10 years, it has been miraculous. There is still a long way to go, but regarding children's cancer, we have made progress. Yet less than 3 percent of adults with cancer are enrolled in clinical trials. We have made some progress in the area of the adult cancers, but that number is in danger of decline. Until recently, the health insurance companies routinely paid for the doctor and hospital costs associated with a clinical trial. In 1998, the CBO found that approximately 90 percent of health insurance companies reimbursed for their patient costs, but HMOs are quickly reversing that lifesaving policy. Many of the HMOs are refusing to allow their patients to participate, leaving them with few alternatives. I want to give the Senator from North Carolina, Mr. Edwards, a quick anecdote. One of the important cancer centers is the Lombardi Center, named after one of the great football coaches, Vince Lombardi. Most people in the Washington area are familiar with that center. Our committee had a hearing at which the director of that center was present. He told us they had to hire more and more people to deal with the insurance companies to persuade the insurance companies to let women who had breast cancer and other cancers participate in these lifesaving trials. That was their big new expense; not trying to treat more people, not expanding the facility, not bringing the benefits of their research and breakthroughs to other people, but to hire more people to tangle with the insurance companies. They had to do this because, for the most part, women were being turned down, even though the possibilities for their recovery were significant. As the Senator knows, under his bill, the McCain-Edwards bill, they still have to meet certain requirements. There has to be the likelihood of progress within the clinical trials. There are protocols that have been established by the FDA and NIH. They have to qualify in these areas. There are requirements that have to be met. We must protect vulnerable populations with these diseases, people who have the hope of being freed of the shackles of sickness. These protections are included in the Edwards-McCain bill. The Frist bill leaves the door ajar but not very much ajar. It allows HMOs to continue to resist applications for clinical trials, resistance that can last as long as 7 or 8 years. As all of us understand, these are timely occasions. Individuals have to be enrolled in these clinical trials in a timely way to benefit. When laying these two proposals side by side, one would have to say that under our proposal the guarantee is there, as it has been historically. And on the other side one would say that there are significant roadblocks and hazards that are being placed in the way of qualified patients to participate in the trials. Madam President, I believe I have consumed most of my time.

Mr. KENNEDY. Madam President, I look forward to continuing this discussion during the course of the day. It is important during this day to point out exactly what is before the Senate. There are those who favor no HMO bill, and there are those who favor an alternative. It is important Members understand exactly the protections that are in the Edwards and McCain legislation, which I think are the types of protections that are in the best interest of the patient and are the result of a great deal of review. These protections have the very strong support of the medical profession. We will have that opportunity later in the day. I yield the floor.

Mr. KENNEDY. Will the Senator yield?

Mr. KENNEDY. Mr. President, will the Senator yield on that point?

Mr. KENNEDY. Mr. President, we were just talking about one such protection that I think is of concern to families all over this country; that is, the clinical trials. As I understand it, just to repeat, our bill has the right to participate in clinical trials without discrimination. The patient may not be denied the right to participate in an approved clinical trial if they or their physician can show that they can be appropriate participants in that trial. We have the right to coverage for routine costs associated with clinical trials, and we have the right to participate in all federally funded or federally approved clinical trials. The other side delays the immediate coverage for routine costs with clinical trials, and the bill has a lengthy negotiated rulemaking process to establish standards for the routine costs that may be covered--a process that may well result in an effective date for insurers as late as January 2007, which adds a 6-year delay. The current Medicare benefit was carefully crafted and fully vetted through the Federal rulemaking. In addition, the Institute of Medicine has also released a comprehensive study by experts in the field recommending Medicare coverage for routine costs. Furthermore, managed care plans that offer the Medicare+Choice option are already required to adhere to the current definition of routine costs. Effectively, we have the clinical trial and the patients protected. In theirs, they don't even follow the Medicare system, which in terms of cost as a result clinical trials, would be very much deferred. As I understand, theirs does not cover the FDA-approved clinical trials. I do not understand that either because it is in the FDA where the pharmaceutical companies are working through these breakthrough drugs which offer enormous kinds of promise. So, as the Senator knows, it is important to look at the fine print on these issues in terms of the protections. I just think we have worked with our good friends--and they are good friends, Senator Frist and Senator Breaux and Senator Jeffords--and we want to try to find common ground to work on this because the differences between us are small compared to those who do not want any bill at all. We want to try to reduce those differences. It is important to note that it isn't just on the issues of liability, of which the Senator from North Carolina spoke, but that he has concern, as do I, about the protections--whether they provide the range of protections he thinks the patients need.