John Edwards

Mr. EDWARDS

Mr. EDWARDS. Would the Senator address two questions, please. First, the fact that the HMOs are denying and not covering patients needing and having access to clinical trials--would he first talk a little about, from his experience and from talking to constituents, what impact that has on the country moving forward in the field of medicine for all of the American people, so we can continue to be the world leader that we have been in the past in advancing medicine in the areas such as Alzheimer's? Second, would the Senator talk briefly about the difference between the McCain-Edwards-Kennedy bill on access to clinical trials and the competing Frist bill?

Mr. EDWARDS. Thank you, Mr. President. Mr. President, I thank the Senator from Tennessee, and the Senators from Louisiana and Vermont for their remarks and for their work on this issue. I did not hear all of the groups that the Senator from Tennessee just read, but the majority of those groups also support our bill. The bottom line is there is a handful of groups that support both bills. Then there are over 600 consumer groups and medical groups, including the American Medical Association, that support our bill. There is a reason for that, which I will discuss in a few minutes. From the start to the finish of these two bills that were analyzed side by side, there are significant differences throughout the bills. In every place there is a difference. In every single place their bill sides with the HMOs and our bill sides with the patient and doctors. That is the reason all of these consumer groups, all of these health care groups, and the AMA support our bill and do not support their bill. It is not an accident. These are people who have been fighting for patient protection and putting health care decisions in the hands of doctors and patients for many years. They believe deeply in this issue. They have looked at these two bills side by side. They understand that there is significant and important differences that aren't abstract. There are differences that affect the lives of thousands and thousands of families and patients all over the country.

Mr. EDWARDS. Yes. I will.

Mr. EDWARDS. I thank the Senator his questions and comments. He is exactly right. There is a difference on the issue of clinical trials in the two bills. I think the Senator from Tennessee suggested the same in his remarks. But there are differences throughout the bill, starting with the issue of coverage and how you determine whether States opt out or do not opt out of the protections in the bill. There is a difference in the access to specialists outside the plan. There are differences between the two bills. There are differences, as the Senator just pointed out, in access to clinical trials, and as the Senator from Tennessee pointed out a few moments ago. There are differences in the independent review process. We specifically say that neither the HMO nor the patient can have any control over the body that picks the reviewing panel or the reviewing panel.

Mr. EDWARDS. I will, yes.

Mr. EDWARDS. Reclaiming my time, the difference is, we have specific language in our bill that says neither the HMO nor the patient can have any relationship or any control over who is the group who picks the reviewing panel, No. 1, or the reviewing panel itself. Their bill is silent on that specific issue.

Mr. EDWARDS. If I could continue, this may be an issue on which, working together, we may be able to resolve our differences. There has been some discussion----

Mr. EDWARDS. If I could finish, then I will be happy to yield. There was a discussion yesterday in this Senate Chamber about the issue of employer liability. The Senator from Tennessee suggested, a few minutes ago, he thought the intent of both bills was to protect employers from liability. I agree with that. I know that is the intent of our bill. And I know, from my discussions with the Senator from Tennessee, that is the intent of his bill. We have gone about it in different ways. We believe our bill in fact protects employers. We believe our bill is totally consistent with the President's principles, to which the Senator from Tennessee made reference earlier. The President, in his principles, specifically said employers should not be subject to lawsuits--I don't have the language in front of me, so I am paraphrasing--unless they actively engage in making medical decisions. That is exactly what we intend our bill to do and we believe our bill does; that employers are protected from lawsuits unless they in fact make medical decisions. Having said that, this is another issue on which I think we should continue our discussion because, particularly given the fact that both sides want to protect employers from liability and want to protect employers from lawsuits, if there is a better and more effective way to do that, which is also fair to patients, we should explore that. I think that is worthy of further discussion as we go forward.

Mr. EDWARDS. Yes, I will yield.

Mr. EDWARDS. That is a fair question. Let me respond to the Senator's question, and then I want to go back to talking about the bill specifically. What our intention is in our bill is to provide an objective third party who chooses who the group is, who contracts and actually selects the review panel, and then chooses the review panel. The Senator will recall, in previous bills that have been talked about and debated in this Senate Chamber, that has been one of the mechanisms used so that you do not have the HMO actually involved in contracting either with the group that is choosing the review panel--I think it is important to talk about both because they are both involved--or the review panel itself. As a practical matter, the HMO is not likely to be choosing the actual review panel because much more likely, in real life terms, as the Senator knows, they would contract with a group that would choose the review panel. What we want, and is the whole intention of our bill--and we think this is a very significant difference between the bills--is we do not want the HMOs--other than the fact that the HMO, I think in both bills, is responsible for the cost--we do not want the HMOs being able to have control either over the group that chooses the review panel or over the review panel itself. I think that is an important distinction between these two bills because the way this process works, both bills are structured--with the exception of this difference that the Senator from Louisiana and I have just discussed--exactly the same way to avoid cases going to court. There has been a lot of rhetoric on the opposing side that our bill will stimulate and foster frivolous lawsuits. The truth of the matter is, our bill does exactly what their bill does to try to avoid cases going to court. Experience has proven, both in California and in Texas, that when you use that structure, which is that an HMO denies treatment, an HMO denies coverage, the first step is to go to an internal review within the HMO. If that is unsuccessful, the second step is to go to a truly independent third party review. If that is unsuccessful, and if the patient in the interim has been injured as a result of the HMO's behavior, then the case can be taken to court--the two States where that process has been used--and I again will say the structure is the same in both bills, the difference being we prohibit the HMO's involvement in the selection of the independent review process.

Mr. EDWARDS. If I can finish, I will be happy to yield. In the two places where that system has been used before, which is in California and Texas, very few lawsuits have been filed. They are two of the biggest States in the country, some would argue two of the most litigious States in the country. They have a system similar to ours, and actually similar in structure to theirs. In both cases, what has happened is that the vast majority of the hundreds and hundreds of claims that have been filed--an HMO denies a claim, the claim then goes to internal- external review--the vast majority of those cases have been resolved by the appeals process. That is what we mean when we say our bill is structured to avoid cases going to court. In fact, in most cases it is in the best interests of the patient to get the care and to get it as quickly as possible. That is the reason for the internal review process. That is the reason for the external review process. That is the process we used in our bill. It is the process they used in their bill. Unfortunately, in some cases, if an HMO arbitrarily or intentionally denies care to a patient--and we have all heard the stories in this Chamber--when that occurs, in some cases a child or a family or a patient can be injured as a result. If that occurs, then that child or family can take their case to court. That is what has been done in Texas. That is what has been done in California. What we have found is what common sense would tell us, which is that the system works.

Mr. EDWARDS. I will.

Mr. EDWARDS. That is correct.

Mr. EDWARDS. I appreciate the comments of the Senator from Louisiana. First of all, he made reference to a creature selecting who the review panel is going to be. We don't want that creature to be the HMO. Looking specifically at the language of our bill, I am looking at page 54 of the bill, it reads: No such selection process under the procedures implemented by the appropriate Secretary may give either the patient or the plan or issuer any ability to determine or influence the selection of a qualified external review entity. . . . I have a question for the Senator. My question is, This language specifically prohibits anybody involved in the process from determining or influencing the selection of a qualified external review entity; would the Senator agree to this language?

Mr. EDWARDS. Will the Senator agree to this language?

Mr. EDWARDS. I just read the Senator exactly what the language says.

Mr. EDWARDS. My question to the Senator is, If you say you agree with us conceptually about this, and we have specifically said that no such selection process implemented by the appropriate Secretary may give either the patient or the plan or issuer any ability to determine or influence the selection of a qualified external review entity, would you agree to that language?

Mr. EDWARDS. The Secretary sets up a process by which the selection of the independent review panel is done and by which the selection of those people who are eligible for the independent review panel is done. The Secretary is responsible for doing that. My point to the Senator is, his bill doesn't say this. By the way, neither the HMO nor the doctor nor the patient can play any role in that process. If the Senator agrees with us on that concept, would he agree with the language I just read to him?

Mr. EDWARDS. It is actually the Labor Secretary.

Mr. EDWARDS. Reclaiming my time, first of all, I thank the Senator for this discussion. I hope we will be able to continue to talk about this. My concern is that we specifically say and designate that the Secretary of Labor shall set up a process by which these people are identified. That process is required by law to not allow any of the people involved in the process, which is only fair, to have any control or any influence over who ends up on the panel. We don't set up a specific process. We give the Secretary of Labor the responsibility for doing that. My point, in response to the Senator's question--then I will go back to the other issues I need to talk about--is that we deal with this issue. He doesn't. I think it is critically important--I am happy to continue working with the Senator--that when you have an independent review, when you have a second appeal after the HMO internally has denied the claim, that whoever is conducting that review and whoever is on that panel not have any connection with the patient, with the doctor, or, probably most importantly, with the HMO. That is the only way we are going to get a fair and impartial review panel.

Mr. EDWARDS. Yes, I will.

Mr. EDWARDS. Reclaiming my time, responding specifically to the Senator's question, what we actually do--I hate to have to keep repeating this--we deal with this issue. You don't. What we do in this bill is we give the Secretary of Labor responsibility for setting up the process. We don't say to the Secretary of Labor: You identify this group of reviewers or these people who are eligible for the review panel. Instead, what we do is give the Secretary of Labor responsibility for setting up the process. But in setting up the process, the Secretary is required to not allow any of the people involved to be able to influence who is on the panel and who is involved. I appreciate very much the Senator's questions. I hope we can continue to talk about this. It sounds to me as if he is genuinely concerned and interested in trying to resolve the issue. We appreciate that, but at this moment we don't have a specific solution to this issue, and we are happy to continue to talk about it. But we believe very strongly--it is the reason we address it in the bill--that the HMO and the people involved should have no role; instead, we should have an impartial process. Just like you want an impartial jury, you have an impartial review process. Now, Mr. President, if I can go back to the overall issue of the bill, and then I want to talk about a particular patient. First, we do want to make it clear to the American people who are listening to this debate that there is a lot of media coverage that suggests that accountability, or taking HMOs to court, is the only major difference between the bills. There are major differences from start to finish--on coverage, on access to specialists outside the plan, on access to clinical trials, as the Senator from Massachusetts suggested a few minutes ago, and on a truly independent review so the decision of the HMO can be reversed, as the Senator from Louisiana and I discussed. Finally, the issue of accountability. There are two goals in our legislation, and we believe they are met. One is to provide real and meaningful patient protection--to put the law on the side of patients and doctors so that the health care decisions are being made by the families affected by them and by the people who have the training and experience to make them--the health care providers--and not by some bureaucrat sitting behind a desk working for an insurance company. Second is to treat HMOs as everyone else. The problem is that some people would suggest that we should help maintain the existing privileged status of HMOs. HMOs are virtually the only entity in America that cannot be held accountable. Their decisions can't be reversed; they can't be appealed; and they can't be taken to court. When they deny coverage, the families are stuck with what they did. We want to simply treat HMOs as every individual American, every small business, every large business; they should be treated the same. If my colleagues think differently about that, and if they believe HMOs are privileged citizens and they ought to be able to maintain some of the privileged status they have today, they will have to make their case. I believe the American people believe that HMOs should be treated just like the rest of us. I said earlier that these debates are not abstract and academic; they are real. They affect people's lives. I want to tell the story today about a young man named Gary Wemlinger and his wife Jerrie who live in my State, in Kernsville, NC. Gary, unfortunately, was diagnosed with kidney cancer some time ago. Specialists at Duke University Cancer Center have told Gary that surgery, radiation, and chemotherapy will not help him. In other words, his life cannot be saved by those treatments. In this photograph are Gary and his wife and his five beautiful children. What they have told him is the only chance he has for recovery and to be able to spend more time with his family is to have a procedure called a stem cell transplant. Now, what we know medically is that stem cell transplants have saved many lives across this country of patients with cancer. But because this is a fairly new treatment, and particularly for Gary's particular kind of cancer, the insurance company has said that it is experimental and, therefore, they won't pay for it. They have refused specifically to pay for it. As you would expect, the people around Gary--his family, friends, neighbors, people in the community--have pitched in and they are working very hard to try to raise the money for Gary to have this stem cell transplant that he so desperately needs. They are having a very hard time coming up with the amount of money that it would cost. This is a perfect example of the effect that the McCain-Edwards-Kennedy bill can have. Under our bill, when Gary needs this stem cell transplant--and his medical doctors at Duke University Cancer Center believe he does--the insurance company not only would be required to give him more serious consideration initially, but once the decision was made not to pay for the care, he would have the right to go to a truly independent medical review board to get that decision reversed. That medical review board, made up of doctors, would consider, among other things, the recommendations of the cancer specialist at Duke University Medical Center who would tell them that the only way Gary's life would be saved is through this stem cell transplant. Otherwise, these other traditional therapies--radiation, chemotherapy, and other surgeries-- will not save his life. This is a perfect example of a man and his family who would be dramatically affected if the law were on his side, on his family's side, instead of being on the side of the big HMOs. We can talk about this a lot. There was a quote today in one of the newspaper stories--which we will make reference to later as the debate goes on--from the HMO lobbying group saying that they are prepared to spend whatever is necessary to stop the legislation from passing. They have already spent many millions of dollars and they will continue to spend millions of dollars, and they have been doing it for years. They want to keep their privileged status. I will tell you who is not spending millions of dollars in this debate. Gary and his family are not spending millions of dollars. They have only us to count on--the people who are in this body and the people down the street on Pennsylvania Avenue. That is who they are counting on, the people they sent to represent them in Washington, DC. You won't see a television ad about this family. You won't see this family spending millions of dollars. Instead, you will see their friends and neighbors and members of their community trying desperately to raise the money that the HMO won't provide. The point is there are clear lines in this debate. While we want very much to work with our colleagues to find a bill that can pass the Senate, pass the House, and will be signed by the President ultimately, we have to make a decision. We have to make a decision about whether we stand with the big HMOs or whether we stand with patients such as Gary and their families.

Mr. EDWARDS. Thank you, Mr. President.

Mr. EDWARDS. Mr. President, first I say to my friend from Nevada, he is mighty lucky to have a son-in-law from North Carolina.

Mr. EDWARDS. We are glad he has a son-in-law from North Carolina. I say to my friend from Georgia, who, some people may not know, lives 6 or 8 miles from the North Carolina line, so North Carolina had a little good influence on him when he was growing up in Georgia. In fact, when I was in western North Carolina not long ago, in the closest town to the Georgia border, they said they started to believe Senator Miller was their Senator, so I had to make it clear to them, no, it was not true; I represented them, although he does a great job of representing all the people of that area. I thank the Senator for a number of things. No. 1, for the eloquence of his speech, because it was so well thought out, so clearly spoken that anyone listening would have understood it. No. 2, for talking about the actual experience as opposed to some of the rhetoric we hear on both sides of this debate on the issue of what effect this kind of patient protection legislation will have on lawsuits and the potential for lawsuits. Georgia in fact has a real experience. We do not need to guess about what has happened down there. They have legislation very similar to ours. In the State of Georgia, there have not only been few lawsuits, there has been none during the time that law has been in place. I know the Senator played a role in helping, with his friends down there, to make sure that law in fact happened. Next, I thank the Senator for his leadership on this issue. As he said, he is no newcomer to this issue. He has been involved in it for a number of years. His expertise and involvement are critically important. Finally, no one cares more about being certain we are not exposing employers to lawsuits than the Senator from Georgia. He has made very clear from the day he walked in this institution that he is a man of strong character, integrity, and independence. There is no doubt in my mind he means what he says. He would not be in support of this legislation--I might add, nor would I, nor would the Senator from Nevada--none of us would support this legislation if we believed it exposed employers to lawsuits. We all care a great deal about that issue, as we care about protecting patients and providing adequate patient protection against some of the HMO abuses that have occurred. I wanted to stand briefly and thank my friend from Georgia, thank him for his cosponsorship of our legislation and thank him for his very clear thinking on this issue which has now been expressed to the American people. I yield the floor.