Ted Kennedy

Mr. KENNEDY

Mr. KENNEDY. Mr. President, today I have the special privilege of acknowledging forty-seven extraordinary individuals who have received this year's ``Heroes Among Us" Award from the Boston Celtics. This past season was the fourth consecutive season that the Celtics have honored these heroes at home games in recognition of the selfless contributions they have made to their communities. Over the last four years, the Celtics have honored over one hundred and fifty men and women with this prestigious award, which is one of the leading community-outreach programs that the Boston Celtics Charitable Foundation has initiated. The Foundation was established to improve the lives and opportunities of young people in New England through local outreach programs. Members of the Celtics are actively involved in these initiatives and I commend their leadership and dedication to this worthwhile activity. The Celtics deserve great credit for all they have done to promote community service programs which have benefited Boston's public schools, raised funds for local neighborhoods, and have given the area's youth the opportunities they need and deserve in order to become active and responsible members of society. These heroes are men and women who represent the great potential of Massachusetts. Their common tie is the commitment to community service that exemplifies the best of our country. The forty-seven heroes honored by the Celtics this year are role models for all of us, and they are living proof that one person can make a difference in the lives of others. These extraordinary individuals saw the opportunity to improve the lives of their fellow citizens, and their leadership has helped brighten the lives of countless others in our community. I commend the Celtics and all of these ``Heroes Among Us'' for their contributions and achievements. I ask that the names of this year's 47 ``Heroes Among Us'' may be printed in the Congressional Record. The list follows: 1. Michael Obel-Omia. 2. Matthew & Miriam Gannon. 3. Betsy & Danny Nally. 4. Greg Zaff. 5. Dr. Stephan Ross. 6. Jane Alexander. 7. Ira Kittrell. 8. Reverend Ross Lilley. 9. Peter Needham. 10. John Burke. 11. Mark Friedman. 12. Deb Berman. 13. Rick Hobish. 14. Anna Ling Pierce. 15. Matthew Kinel. 16. Officer Bill Baxter. 17. Gene Guinasso. 18. Rocky Nelson. 19. Monsignor Thomas McDonnell. 20. Marianne Moran. 21. Ron Adams. 22. Robin & Caitlin Phelan. 23. Janet Lopez. 24. Sergeant Tavares. 25. George Greenidge, Jr. 26. Maria Contreras. 27. Lieutenant Paul Anastasia. 28. David Waters. 29. Barbara Whelan. 30. Judge Reginald Lindsay. 31. Dennis Fekay. 32. Sarah-Ann Shaw. 33. John Engdahl. 34. Anne Carrabino. 35. Deborah Re. 36. Officer Scott Provost. 37. John Iovieno. 38. Dan Doyle. 39. John Rosenthal. 40. Pam Fernandes. 41. Al Whaley. 42. Matthew Pohl. 43. Anna Faith Jones. 44. Billy Starr. 45. Jetta Bernier. 46. Laura Goldstein. 47. Nikki Flionis.

Mr. KENNEDY

Mr. KENNEDY. The other side has 28 minutes?

Mr. KENNEDY. Madam President, I understand we have 5 minutes left?

Mr. KENNEDY. Madam President, I yield 5 minutes to the Senator from North Carolina.

Mr. KENNEDY. Madam President, I withhold the rest of the time and hope the McCain amendment will be approved. How much time remains on either side, Madam President?

Mr. KENNEDY. Madam President, the sense-of-the-Senate we will vote on soon is a critical one. It puts the Senate on record as supporting patients in two critical areas covered by our bill: Access to clinical trials and access to specialty care. The reason this vote is critical is that adoption of this sense-of- the-Senate language effectively endorses the solid protections contained in the McCain-Edwards-Kennedy bill and rejects the inadequate protections contained in the alternative legislation. Our friends on the other side of the aisle started out rejecting the idea that managed care companies should be required to cover the routine doctor and hospital costs of quality clinical trials. Then they said they would support coverage of clinical trials, but only for cancer. Now they have finally endorsed the idea of covering clinical trials, but they continue to offer the American people coverage that is unconscionably delayed and that bars patients from some of the most crucial clinical trials--studies carried on in the private sector that are not funded by the Government but are approved by the Food and Drug Administration. Of course, this, too, represents a shift in position. Last year they were for coverage of FDA trials, but only for cancer patients. This sense-of-the-Senate makes clear that managed care companies should cover the routine doctor and hospital costs of all clinical trials that offer a meaningful opportunity for cure or improvement. It also makes clear that coverage should be provided without further delays--no ifs, ands, or buts. If someone can benefit from a clinical trial, if their doctor recommends it, and if they want to participate in it, their insurance company should pay the routine doctor and hospital costs associated with the trial. I reviewed the comments my good friend Senator Frist made last night, and the sum and substance of it was that clinical trials are a wonderful thing but it might cost too much if insurance companies have to pay for routine doctor and hospital costs. So he was willing to cover some of the trials but not all of the trials. Now of course this specter he has raised of the vast unknown mass of clinical trials out there ignores some fundamental facts. First, most studies have not found much difference between the cost of clinical trials and the cost of conventional care. Obviously, there are cases where a clinical trial can cost more, but there are also cases where it can cost less. Second, Senator Frist talks as if we are proposing something novel and dangerous. The fact is that CBO found several years ago that insurance companies routinely pay these costs. They pay them 90 percent of the time. But managed care is cutting back on that wise policy and patients are being left to bear the burden. So we are not talking about imposing something new. We are talking about preserving and restoring what is already there. We are simply extending to the private sector a policy that works well under Medicare. One of the most fundamental parts of quality medical care is access to an appropriate, qualified specialist to treat serious complex conditions. This is also one of the areas in which the abuses of managed care have been most serious and widespread. Our legislation provides patients the opportunity to see a specialist outside the managed care network at no additional cost if no one in the network can meet their needs. The competing legislation offered by Senator Frist purports to afford the same rights, but it essentially makes the plan the judge and jury of whether or not a non-network specialist is needed. The plan's judgment is not appealable. Senator McCain's sense-of-the-Senate simply affirms the right to see a specialist outside of the network, if needed. It also affirms the right to appeal to an independent third party if the plan disagrees about the need to go outside the plan. These rights are especially critical to cancer patients. That is why cancer patients are specifically mentioned in the McCain sense-of-the- Senate. It is also why so many organizations representing cancer patients and their families have spoken out so strongly in support of our legislation. The story of the following patient illustrates why these rights are so precious and why the passage of the McCain amendment is so critical. The family of Carly Christie was horrified when their 9-year-old daughter was diagnosed with a Wilms' tumor, a rare and aggressive form of kidney cancer. They were relieved to learn that a facility close to their home in Woodside, CA, the Lucile Packard Children's Hospital at Stanford University, was world renowned for its expertise and success in treating this type of cancer. The Christie family's relief turned to shock when their HMO told them it could not cover Carly's treatment by the children's hospital. Instead, they insisted that the treatment be provided by a doctor in their network, an adult urologist with no expertise in treating this rare and dangerous childhood cancer. The Christies managed to scrape together the $50,000 they needed to pay for the operation themselves. Today, Carly is a cancer-free, healthy, happy teenager. If the Christies had been less tenacious or had been unable to come up with the $50,000, there is a good chance Carly would be dead today. The Christies had faithfully paid their premiums to their HMO, but their HMO was not faithful to them when their daughter's life was in jeopardy. The protections in our legislation would have avoided that situation. No family should have to go through what the Christies did. No child should face a possible death sentence because an HMO thinks profits are more important than patients. The McCain amendment puts the Senate on record as saying that families such as the Christies should have the right to a speedy, fair appeal to an independent review agency to get the care their daughter needed.

Mr. KENNEDY. Yes, from the sponsor's time.

Mr. KENNEDY. I yield myself 7 minutes.

Mr. KENNEDY. Madam President, how much time is remaining now?

Mr. KENNEDY. That is fine. I thank the Senator. I think there was the hope and desire--I don't think there was the expectation that we would vote later in the afternoon today, but there was hope that we could perhaps get a time definite for a vote on that Tuesday morning. I will let the leaders work that out with the Senator from Texas later on.

Mr. KENNEDY. How much time would he like on this amendment?

Mr. KENNEDY. Would the Senator give us some idea as to the time the Senator from Texas wants to consider this amendment?

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

Mr. KENNEDY

Mr. KENNEDY. Mr. President, may I proceed for 30 seconds?

Mr. KENNEDY. I thank the Senator.

Mr. KENNEDY. I inquire of the Senators, would they be interested in entering into a time agreement for this amendment?

Mr. KENNEDY. Twelve minutes. I yield 6 minutes to the Senator from California and 6 minutes to the Senator from Florida.

Mr. KENNEDY. Mr. President, I yield myself 10 minutes. I listened with great interest to the points made by my friend from Wyoming, Senator Enzi, on the issues regarding employer responsibility. It was a good discussion. I hope he will have an opportunity to read what the President of the United States urged Members to do: Only employers who retain responsibility for making final medical decisions, should be subject to the suit. I know what he is against; I am not quite sure what he is for. Here is the principle to which we are committed, and to which the President is committed. If he has some problems, or suggestions on how to achieve it, we welcome that. We strongly support what the President has stated is his objective in terms of employer responsibility. We will have more of an opportunity to address that issue. I listened to just about every speaker from that side talk about their concern for the growing number of the uninsured. That is mentioned in every speech. I yield to no one in my strong commitment towards getting coverage for the uninsured. However, I remind them of their own priorities. They believe the best way to extend coverage is to try and provide tax credits and tax incentives. I have a real concern about that because the people who don't have that insurance don't pay the level of taxes to benefit from the credits or the deduction. We can debate that another day. However, 75 to 80 percent of those who do not have insurance will not benefit. It will benefit others who have the insurance, but it will not extend the coverage. Nonetheless, that is a debatable point. The Republicans had provisions in their budget to extend coverage. They dropped them all. They dropped them all in conference with the House of Representatives. They didn't fight for those provisions. They fought for greater tax breaks for the wealthiest individuals in the country, but they cast those provisions aside. I hope they do not continue raising this issue in the Senate. I wish they had fought for this issue in their conference. They let those provisions go. That bill had anywhere from $60 to $70 billion in provisions to extend coverage when it left, and those provisions were wiped out. If they were committed to it, we want to know what they intend to do now. It is a nonissue because, as was pointed out yesterday by the Senator from North Carolina and others, when the States have enacted a strong Patient's Bill of Rights, the actual number of the uninsured has gone down. The total number of insured has gone up. That is true in California, that is true in Georgia, and that is true in Texas. They can use whichever argument they want, but they have to get their facts straight. The facts are, even in the States which passed tough HMO bills, there have not been the increases that some expressed concern about. We have seen that expansion of coverage to the uninsured has not been their priority. These are effectively smokestacks. We want to keep focused on the target. I listened to my good friend, Senator Brownback, talk about the Business Roundtable and their concerns about the legislation. He feels that we ought to heed their concerns. We heard their concerns when we were dealing with the Family and Medical Leave Act. They said it would cost anywhere from $25 to $27 billion; we cannot do it. We will lose; we will have more people laid off; it will be the end of the free enterprise system, they said. Guess what. It is working. We intend to try and expand it. It has made a big difference. It still has not done all the things many who supported the program desired. There are too many workers who will not take the family and medical leave because they lose their pay. They lose pay because they are always caught between the child who is sick, the parent who is desperately ill, and taking the family and medical leave to tend to that. These are hard-working Americans who need that paycheck every week, and many of them cannot take the leave. Most other industrial nations have paid family and medical leave. We don't. The Business Roundtable opposed that legislation, but it is working today. I don't hear a single Republican trying to repeal it. They are not out there trying to repeal it. Then we had the Kassebaum-Kennedy bill to provide portability on health insurance for disabled. We heard premiums would go up from 25 percent to 31 percent, and that this would be the end of the employer-based health insurance program. It has not happened. It has gone up 2.7 percent over a 3-year-period, which was the estimate at the time that was used by those who supported the program. The other estimates were widely off base. Regarding the increase in the minimum wage, the last time we had an increase in the minimum wage they said we would lose 400,000 workers. In the first quarter, we increased employment by 300,000 workers. They were wrong. They said it would add to rates of inflation, and we had the greatest rate of growth in the country. They were wrong. Three for three, they were wrong. Rather than listening to their theories, look at what is happening in the country today. Look at the States where they have a tough, effective, Patients' Bill of Rights and what has been the result of the employer-based system. We find still that the number of insured or uninsured is not related to this issue. The increase in the numbers covered are primarily a result of the expansion of the CHIP program. It has been a modest change. Second, there have not been great abuses of employers' liability. The most recent example is the State of California which passed a very good, effective, tough, HMO bill that has been in effect 9 months. There has not been a single case that has actually gone to trial. There have been over 200 cases that have gone to appeal, and they have been decided 65 percent for the HMO, and the rest for the patient. The HMOs, as well as the consumer groups, are incredibly impressed by the way it is working. That is what we want this bill to do. It is a favored technique around here: If you are opposed, distort it, misrepresent it, exaggerate different provisions on it, draw up all kinds of smokescreens and red herrings. But these distortions won't work because we have practical experiences to draw upon. We can see in the States how this can work, how we can function, and what the impact will be. I will spend a few minutes talking about what this bill is about. There are efforts to bring the Senate off message on this but it is important to remember what the debate is about. It is not about lawyers. It is not about insurance companies. It is about patients. It is about people who are mothers, daughters, fathers and sons, sisters and brothers. It is about families all over the country who will some day face the challenge of serious illness and deserve the best in health care. They deserve the same care that all Members of the Senate would want for themselves and their loved ones. Too many of those families are denied the care they need and deserve because of the abuses of HMOs and the other insurance companies. The legislation we are considering today will end those abuses, and, as we enter this debate, I would like to spend a few moments talking about the importance of three of its provisions--access to needed specialty care, access to clinical trials, and access to needed prescription drugs. In each of these areas, needed care has too often been delayed and denied by insurance companies that are more interested in profits than in patients. In each of these areas, the opponents of our bill want to create loopholes that will make these guarantees only an empty promise. Access to specialty care when serious and complex illnesses strike is a critical element of good health care. Denial of access to needed specialists is also one of the most common abuses in the current system. According to a survey by the University of California School of Public Health, 35,000 patients every day are denied specialty referrals. One of those patients was little Sarah Pederson of San Mateo, California. This is her picture. Sarah was born with a brain tumor. When she was three, it became clear that she needed aggressive treatment to save her life, including brain biopsies and chemotherapy. Her neurosurgeon knew that Sarah needed to be seen by a doctor specializing in brain tumors in children--and there was no qualified doctor in the plan. When Sarah's mother, Brenda, a nurse, asked to go outside the network, her HMO said, ``No.'' The HMO told her, ``We're not giving you second best, we're giving you what's on the list.'' After months of fighting with the HMO, it finally agreed to let Brenda see someone qualified to treat her condition. When Sarah finally got to the right doctor, her chemotherapy began. Everyone knows chemotherapy causes severe nausea and vomiting. The HMO denied Sarah's $54 prescription for antinausea medication, because it was ``too expensive.'' Finally, Sarah's family was able to switch insurance companies and get proper care for their child. So there you have it. Two parents facing one of the worst nightmares a family can have--a child with a cancer--and instead of being able to focus on dealing with the terrible stress and working to give their child all the comfort and assistance they can--they have to spend their energy fighting with an insurance company simply to get the child to an appropriate specialist. Sarah was lucky, in the sense that the HMO's delays did not kill her. But what a burden for her family to face. What a travesty of common decency. Passage of our legislation will assure that every family with a child who has cancer can get the specialty care they need without dangerous delays. Women with cancer face special burdens. They must cope with a dread-- and often deadly--disease. They need prompt specialty care. And often, their best hope for a cure or precious extra months or years of life is participation in a clinical trial. But, too often, both are lacking. In one of the many forums we held on the issue of access to specialists for cancer patients, we heard from Dr. Mirtha Casimir, a distinguished Texas oncologist. Dr. Casimir talked about the heartbreaking stories of cancer patients whose HMOs delay and deny access to specialty care--often until it is too late. She said that when she gets a patient whose cancer has progressed substantially from initial diagnosis to the time they are allowed to seek needed specialty care, she often flips to the front of the chart--and nine times out of ten the insurer is an HMO. Every centimeter a cancer grows can mean the difference between a good chance at life--and the likelihood of death. Every centimeter represents potentially devastating--and avoidable-- pain, suffering, and death for a patient and a family. Dr. Casimir's message was clear: pass the Patients' Bill of Rights so that more cancer patients will not die needlessly. Mr. President, I see my colleagues who wish to speak. I think we have about 15 minutes.

Mr. KENNEDY. I yield such time as the Senator desires.

Mr. KENNEDY. I suggest the absence of a quorum.

Mr. KENNEDY. From the Cancer Leadership Council: On behalf of cancer patient advocates, health care professionals and research organizations, the undersigned organizations thank you for your vital leadership in introducing a Patients' Bill of Rights that provides comprehensive coverage for routine patient care costs in clinical trials. Notably, your legislation covers ALL high quality clinical trials, not just those sponsored by government funding agencies. As cancer drug development is increasingly undertaken by the pharmaceutical and biotechnology industries, it is essential that their trials be accessible to cancer patients, and your legislation will achieve this result. In addition, your bill provides a workable definition of ``routine patient care costs'' that will enable implementation to proceed expeditiously. That is what the McCain amendment is all about. The American Cancer Society talks about increased access and about assuring that the cancer patients who need access get access to clinical trials. Access must be available to trials that involve lifesaving treatments provided in both federally and privately funded trials. Approved high-quality peer reviews are an essential component of this process. Clinical trials should have the same coverage for routine patient care costs as patients receiving standard care. This is an enormously important protection for the American people. We should embrace it, endorse it, and ensure this kind of patient protection is included in any successful Patients' Bill of Rights legislation. Exhibit No. 1 American Cancer Society, Washington, DC, June 13, 2001. Hon. Edward M. Kennedy, U.S. Senate, Washington, DC. Dear Senator Kennedy: 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 S. 283/S. 872, 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. Specifically, we advocate patient protection legislation that provides all insured 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 trails 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 medical specialists. Patients facing serious or life threatening illnesses, such as cancer, need continuity of care, the option of designating their specialist as their primary care provider, and the ability to have a standing referral to their specialist for ongoing care. Strong, independent, and timely external grievance and appeals procedures. As of today, the ``Bipartisan Patient Protection Act of 2001'' (S. 283/S. 872) is the only bill under consideration by the Senate that fully meets these criteria. We are particularly pleased that S. 283/S. 872 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. Clinical trials are a critical treatment option for current 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 possibly life- saving treatment. S. 283/S. 872 would remove this financial barrier by requiring health insurance plans to cover the same routine patients care costs that they would cover if the patient were receiving standard therapy. It is important to note that the legislation would not require the health plans to cover new costs--they would not be required to cover research-related costs or even the cost of the actual drug. The Society also strongly supports the clinical trials provision because it offers patients access to a broad range of clinical trials--including new drug trials approved by the Food and Drug Administration (FDA)--helping to ensure that no one is left behind as we march forward in our fight against cancer. The recently FDA-approved oral anti-cancer drug Gleevec is a prime example of the important role privately- funded trials play in our War Against Cancer. This revolutionary new drug, developed by the pharmaceutical industry, has offered hope to many patients suffering from chronic myelogenous leukemia (CML). Just as the Society believes that health insurance plans should cover the same routine patient care costs that they would cover if the patient were receiving standard therapy, we also believe that this requirement should be the same regardless of who is funding the trial. Patients continue to pay premiums for this care and should not be forced to go through burdensome administrative hurdles solely because their best treatment option is being developed by the private instead of the public sector. As a result, the Society feels very strongly that any clinical trials provision adopted by Congress must include the innovative treatments being developed in FDA- approved trials. While we appreciate the efforts of Senators Frist and Breaux to include a clinical trials provision in their alternative bill, S. 889, the provision falls far short of the protections needed by cancer patients. Specifically, the Frist-Breaux proposal would exclude many new drug trials that are approved by the FDA--trials that are essential to providing quality cancer care. S. 889 would also create a negotiated rulemaking procedure to develop a new definition of routine patient care instead of relying on the existing Medicare definition already in use. It is important to note that this definition has already been vetted through a federal rulemaking procedure. Further, managed care plans who participate in MedicareChoice are already following the Medicare definition. Duplicating this effort would be a waste of scarce federal resources and subject patients to a needless waiting game that could be the difference between life and death for some cancer patients. The diagnosis of cancer is devastating--patients must not only confront an array of medical decisions, they must cope with the financial and emotional burdens as well. We strongly believe that cancer patients in managed care plans must be assured of access to clinical trials this year and hope to continue to work with you to achieve our mutual goals. Cancer patients have been waiting for enactment of a strong, comprehensive Patients' Bill of Rights for several years. For many current and future cancer patients, enactment of this legislation is a life-or-death issue. Please do your part and support S. 283/S. 872, the ``Bipartisan Patient Protection Act of 2001.'' If you or your staff have any additional questions, please contact Megan Gordon, Manager of Federal Government Relations (202-661-5716). Sincerely, Daniel E. Smith, National Vice President, Federal and State Government Relations.

Mr. KENNEDY. Mr. President, I too, join my colleagues in commending the Senator from Arizona for bringing this to our attention. It brings focus to two very important protections of this legislation. It is appropriate we bring focus to these two protections. Many of the other protections are essential as well, but I think these two are of special importance and concern because the clinical trials part of this legislation is the key, the basis of translating the breakthrough drugs to American families. If we do not have the clinical trials, that is not going to happen, and we are in the century of life science. Specialty care is of enormous importance. We may have challenges in our health care system, but we have well-trained, highly skilled professionals. Specialization has brought a quality of instruction, comprehension, and experience to so many of our medical professionals that their knowledge in areas of specialization every single day makes extraordinary differences to families. The Senator from Arizona has brought special focus to both of these areas. I want to mention a few points about why I think this amendment is needed and why I support it. I will explain the reason why this amendment is important. Two of the biggest loopholes in the bill sponsored by our opponents are in the sections providing access to clinical trials and specialty care. Under their bill, the patients do not have access to critical FDA-approved clinical trials. Access to trials is potentially delayed for years because of a cumbersome administrative process. Their proposal for access to speciality care is not a right because it lets the HMO decide whether the child needs specialty care, but the decision is not appealable. Do my colleagues understand that? If you have a situation where a child has cancer, as my own son did--we went to our general pediatrician, and he was able to tell us very quickly about the importance of going to a pediatric oncologist. He visited an oncologist and received recommendations and supervision. There are about 2,000 of these cases each year. He was admitted into a clinical trial in which 22 children at that time had actually survived. But that particular clinical trial was breathtaking in its success. There are still a number of fatalities, but it changed from about a 10 or 15 percent chance of survival to only a 10 or 15 percent chance of mortality. I have seen the importance of this in a very important way. A ``yes'' vote on this amendment will effectively take this issue off the table and put the Senate on record as saying that women and children with cancer, and any American with a dreadful disease, should have the opportunity to see a specialist qualified to treat the disease. They should have the opportunity to participate in a potentially lifesaving clinical trial. Earlier today, I was talking about the importance of specialty care when serious and complex illnesses strike. It is critical to get the best specialty care that is needed. Denial of access to needed specialists is also one of the most common abuses in the current system. According to a survey at the University of California School of Public Health, 35,000 patients every day are denied specialty referrals. One of those patients was little Sarah Pedersen of San Mateo, CA. Sarah was born with a brain tumor. When she was 3, it became clear she needed aggressive treatment to save her life, including brain biopsies and chemotherapy. Her neurosurgeon knew that Sarah needed to be seen by a doctor specializing in brain tumors in children, and there was no qualified doctor in her family's health plan. When Sarah's mother, Brenda, a nurse, asked to go outside the network, her HMO said no. The HMO said: We are not giving you second best, we are giving you what is on the list. After months of fighting with the HMO, it finally agreed to let Sarah see someone qualified to treat her condition. Her chemotherapy began. Everyone knows chemotherapy causes severe nausea and vomiting. The HMO denied Sarah's $54 prescription for antinausea medication because it was too expensive. Finally, Sarah's family was able to switch insurance companies and get proper care for their child. There you have it, two parents facing one of the worst nightmares a family can have: a child with cancer. Instead of being able to focus on dealing with that terrible stress and working to give their child the comfort and assistance they can, they have to spend their energy fighting with an insurance company simply to get the child access to an appropriate specialist. Sarah was lucky in the sense that the HMO's delays did not kill her, but what a burden for her family to face and what a travesty of common decency. Passage of our legislation will assure that every family with a child who has cancer can get the specialty care they need without the dangerous delays. Women with cancer face special burdens. They must cope with a dreaded and often deadly disease. They need prompt specialty care. Often their best hope for a cure or precious extra months or years of life is participation in a clinical trial, but too often both are lacking. When a woman with advanced breast or cervical cancer reaches a qualified specialist, the best--and sometimes the only--therapeutic choice is participation in a clinical trial. But too often, women with cancer and their physicians must fight HMOs to take advantage of this opportunity. Diane Bergin, a wife and mother of three children, suffered from ovarian cancer. Participation in clinical trials has prolonged her life, gave her hope, and offered the prospect of better care for future women suffering from this terrible disease. She was allowed to participate in clinical trials--but she had to fight every step of the way--and she knows that other women were not so fortunate. Here is what she said, ``No one facing a serious illness should be denied access to care because that treatment is being provided through a clinical trial. Sometimes, it is the only hope we have. And the benefit to me, whether short or long-term, will surely help those women who come after me seeking a cure, a chance to prolong their life for just a little while, just so that they can attend a graduation, or a wedding, or the birth of a grandchild.'' Traditionally, the insurance companies have paid the routine doctor and hospital costs associated with clinical trials. According to the CBO, 90 percent of the cost of such trials is paid by the insurance companies. But managed care is reversing that policy, with devastating effects on patients and researchers alike. Diane Bergen was a patient at the Lombardi Cancer Center in Washington. Karen Steckley, a nurse, is director of clinical operations at the center. She has eight full-time master level nurses on her staff who spend virtually all of their time, not in patient care, but in arguing with managed care companies. These companies do not want to pay for clinical trials, even when it is clearly the best treatment available for a patient. Often Ms. Steckley's team is able to get patients into trials. But sometimes they fail and patients suffer or die needlessly as a result. Our legislation will end this abuse. That is one reason it has been endorsed by virtually every organization in the country representing cancer patients. We have heard moving testimony on the subject. In one of the many forums we held on access to specialists for cancer patients, we heard from Dr. Mirtha Casimir, a distinguished Texas oncologist. Dr. Casimir talked about the heartbreaking stories of cancer patients whose HMOs delay and deny access to specialty care--often until it is too late. When Dr. Casimir gets a patient whose cancer has progressed substantially from the initial diagnosis to the time they are allowed to seek needed specialty care, she often flips to the front of the chart. Nine times out of ten, the insurer is an HMO. Every centimeter a cancer grows can mean the difference between a good chance at life and the likelihood of death. Every centimeter represents potentially devastating and avoidable pain, suffering, and death for a patient and a family. Dr. Casimir's message was clear: Pass the Patients' Bill of Rights so more cancer patients will not die needlessly. That is exactly what the McCain amendment will accomplish, something which the underlying amendment on clinical trials fails to do. Congress took action last year in the area of the Medicare and Medicare Plus by establishing the protocol for shared costs between the industry and clinical trials. All of that was worked out. The basic agreement is completely consistent with the Institute of Medicine's recommendation. It is working and working well. Yet under their proposal, they have to go through the whole administrative process once again to try to determine the costs. The best estimates would take 5 to 6 years. That kind of delay is not acceptable. The opponent's bill also excludes FDA trials which, as we have mentioned previously, are a source of enormous importance. So many of these trials involve pharmaceutical companies on the cutting edge of breakthrough drugs, drugs that offer enormous opportunities. A patient cannot even gain entrance into the clinical trial unless the doctor makes the determination that there is a reasonable chance of success. Still, under the Frist-Breaux proposal, the clinical trials provision does not give the clear guarantees that are in the McCain amendment. I ask unanimous consent that two letters be printed in the Record at the conclusion of my remarks, one from the American Cancer Society and another from the Cancer Leadership Council.

Mr. KENNEDY. Madam President, I think, under the previous agreement, there is going to be recognition of the Senator from Arizona. We have a very important amendment now that will be offered by the Senator from Arizona. We will only have an hour of debate time in the morning. We will come in at 9:30. There will be a half hour on each side to debate this. But this is very important. I hope our colleagues will pay close attention to the Senator and those who address this issue tonight. We look forward to having a good debate and discussion on this measure.

Mr. KENNEDY

Mr. KENNEDY. I yield myself 5 minutes. Madam President, this is a very important day in the lives of families across this country. Today we are addressing one of the principal concerns of families from Maine to Florida, from the State of Washington to California, and the heart of the Nation. That is, are we going to make sure that medical decisions, decisions being made by doctors, nurses, and families, are going to be the final decisions in terms of treatment and care for those particular patients? That is what the issue is all about. As all of us have seen, we have countless examples where those decisions are being overridden by HMOs and bureaucrats and bean counters. They are making medical judgments, effectively practicing medicine, which they are clearly not qualified to do. As we have seen in the Senate with countless illustrations, that just about every Member has shared, they have caused enormous damage to, and sometimes even cost the lives of, these patients. The protections we stand for are reasonable. They are sensible. They are common sense. When we get to the debate on this issue, we will have a chance to review them. We have waited 5 long years since this legislation was introduced to come to this day. We have not had the opportunity to the present time. We have had 14 days of hearings. We have the support of more than 800 organizations. There are few, if any, medical organizations which represent children, women, parents, the disabled, or any of the other patients organizations, that do not support the proposal which has been introduced by Senators McCain, Edwards, myself, and others. We take heart that we are advocating for the doctors and nurses in America. They have committed themselves to help those in need, and have acquired the skill and training to make a difference in the lives of these patients. The fact is, this should not be a partisan issue. It is not. It is bipartisan in the Senate, and it is bipartisan in the House. We welcome our friends on the other side to join with us. As was mentioned previously, the essential aspect of this legislation has been supported by 63 Republicans in the House of Representatives. There are important leaders in the Republican Party, including Dr. Norwood, who have led this crusade in the House and continue to do so. This bill is bipartisan, and has the virtual unanimity of the medical professions and patient organizations behind it. It comes with a series of recommendations which are common sense in their nature, and effectively holds the HMOs liable if they take action that is going to cause injury. This is an important formula for good quality health care in America. As we have said so often, when we have effective accountability and effective liability, these provisions are rarely used. We have seen this in recent examples from California and Texas. What they do reflect is additional quality protections when they are included in the law. That is what we are interested in. Those of us who are supporting this measure know what it is all about: It is for the care and protection of patients. We have had a chance to examine it. This issue has been studied, restudied, and studied again. I look forward to a strong vote at the appointed hour.

Mr. KENNEDY. Madam President, as I understand, the time between 9:20 and 9:30 is evenly divided.