[Joint House and Senate Hearing, 109 Congress] [From the U.S. Government Publishing Office] S. Hrg. 109-53 MEDICAL LIABILITY REFORM ======================================================================= HEARING BEFORE THE JOINT ECONOMIC COMMITTEE CONGRESS OF THE UNITED STATES ONE HUNDRED NINTH CONGRESS FIRST SESSION __________ APRIL 28, 2005 __________ Printed for the use of the Joint Economic Committee U.S. GOVERNMENT PRINTING OFFICE 21-772 WASHINGTON : 2005 _____________________________________________________________________________ For Sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512�091800 Fax: (202) 512�092250 Mail: Stop SSOP, Washington, DC 20402�090001 JOINT ECONOMIC COMMITTEE [Created pursuant to Sec. 5(a) of Public Law 304, 79th Congress] HOUSE OF REPRESENTATIVES SENATE Jim Saxton, New Jersey, Chairman Robert F. Bennett, Utah, Vice Paul Ryan, Wisconsin Chairman Phil English, Pennsylvania Sam Brownback, Kansas Ron Paul, Texas John E. Sununu, New Hampshire Kevin Brady, Texas Jim DeMint, South Carolina Thaddeus G. McCotter, Michigan Jeff Sessions, Alabama Carolyn B. Maloney, New York John Cornyn, Texas Maurice D. Hinchey, New York Jack Reed, Rhode Island Loretta Sanchez, California Edward M. Kennedy, Massachusetts Elijah E. Cummings, Maryland Paul S. Sarbanes, Maryland Jeff Bingaman, New Mexico Christopher J. Frenze, Executive Director Chad Stone, Minority Staff Director C O N T E N T S ---------- Opening Statements of Members Representative Jim Saxton, Chairman, a Representative in Congress from New Jersey................................................ 1 Senator Jack Reed, Ranking Minority Member, a U.S. Senator from Rhode Island................................................... 3 Representative Maurice D. Hinchey, a Representative in Congress from New York.................................................. 18 Witnesses Statement of Mark McClellan, M.D., Ph.D., Administrator, Centers for Medicare and Medicaid Services................................. 5 Submissions for the Record Prepared statement of Representative Jim Saxton, Chairman........ 29 Prepared statement of Senator Jack Reed, Ranking Minority Member. 35 Prepared statement of Mark McClellan, M.D., Ph.D., Administrator, Centers for Medicare and Medicaid Services..................... 36 Information provided to Mr. Hinchey from Dr. McClellan, from the Office of the Actuary, U.S. Department of Health and Human Services....................................................... 44 U.S. Department of Health and Human Services Report entitled ``Securing the Benefits of Medical Innovation for Seniors: The Role of Prescription Drugs and Drug Coverage,'' provided to Mr. Hinchey........................................................ 46 MEDICAL LIABILITY REFORM ---------- THURSDAY, APRIL 28, 2005 United States Congress, Joint Economic Committee, Washington, DC. The Committee met, pursuant to notice, at 10:05 a.m., in room 2226, Rayburn House Office Building, the Honorable Jim Saxton, Chairman of the Committee, presiding. Present: Representatives Saxton, Hinchey, and Cummings. Senator Reed. Staff present: Chris Frenze, Dan Miller, Brian Higginbotham, Colleen Healy, John Kachtik, Tom Miller, Chad Stone, John McInerney, Daphne Clones Federing, and Nan Gibson. OPENING STATEMENT OF REPRESENTATIVE JIM SAXTON, CHAIRMAN Representative Saxton. Good morning, Dr. McClellan. Welcome. Dr. McClellan. Good morning. Thank you, Mr. Chairman. Representative Saxton. We will begin the hearing. I would like to make a short statement which emphasizes what I think is the tremendous importance of the subject that we are here to discuss today. In doing so, it is a pleasure to welcome Dr. Mark McClellan to the Joint Economic Committee. Dr. McClellan brings a wealth of experience and knowledge to bear on the subject of medical liability insurance, tort medical liability reform. Currently, Dr. McClellan serves as Administrator of the Centers for Medicare and Medicaid Services, overseeing approximately one- third of the health care spending of the U.S. In addition to being a board-certified physician of internal medicine, Dr. McClellan is a Ph.D. economist. He has previously served as the Commissioner of the Food and Drug Administration and as a member of President Bush's Council of Economic Advisers. There is little doubt that our Nation's medical liability laws need reform. Over the past few years, premiums have skyrocketed. In just the last 5 years, total medical liability costs jumped 47 percent to a record high of $27 billion. I would just like to refer everybody to this chart. Maybe you could turn it so that we can see it here and they can see it in the audience perhaps a little bit better than that. In looking at this chart this morning, I was absolutely amazed. I knew that medical liability malpractice costs had gone up, but when I looked at this and saw that kind of in the middle, among the middle bars there, there is a $9.2 billion mark; that was 1990. Today, medical malpractice costs are almost $27 billion. So since 1990, medical malpractice costs have actually tripled in just those few years. This is indeed an issue that bears close examination. One of the central cost drivers is rising claims costs. According to the legal research firm Jury Verdict Research, the median trial award for medical liability claims stands at an incredible $1.2 million, and a recent Department of Justice study reported that nearly two-thirds of medical liability trial awards exceed $250,000. Here is another chart that shows growth in median liability claims. As recently as 1997, the median liability claim, as represented by the shortest bar to the left of the chart, was $500,000. Today, as I mentioned a minute ago, the median trial award for medical liability claims stands at an incredible $1.2 million. Once again, just since 1997, these claims have more than doubled. This rise in costs has reached the point where the quality and availability of health care suffer. Faced with premiums increasing 20 to 30 percent a year, many doctors are cutting back on the scope and availability of their services. Nowhere is this trend more apparent than in obstetrics, where numerous OB/GYNs have decided it is just easier to drop OB altogether. Some doctors have elected early retirement or have relocated away from high litigation areas. Emergency rooms and trauma centers have also been hurt by the current crisis. The threat of lawsuits has made the practice of defensive medicine commonplace, and as a result, patients are subjected to more tests and procedures than may be warranted by clinical factors alone. Despite the rise in costs, the system is not better at compensating the negligently injured. The typical time that elapses between the date of injury and a verdict is close to 5 years. And, of course, legal fees go on during that period of time. Moreover, it is widely recognized--and this is an unbelievable fact that we came across in studying this subject a year or so ago--it is widely recognized that only a small fraction of negligently injured patients even file a claim. At the same time, a large majority, around 80 percent, of medical liability claims do not even involve negligent injuries. One study even found that more than half of all medical liability claims do not involve an injury at all. The shortcomings in the current tort system are such that The Washington Post has noted that, and I quote: ``The staggering costs of America's civil justice system are unacceptable. The tort system is something of a casino, offering windfall judgments to a small number of claimants and nothing to others--with the merits of cases seeming almost irrelevant to their valuation.'' Although each State faces its own set of challenges and problems, the medical liability crisis has nonetheless reached national proportions. I wonder if we could put the chart up of the map of the U.S. so that I can just point out that some States have taken steps to mitigate the problem. The States in red are represented--this is an American medical liability cost and national view put out by the American Medical Association, just so that everyone knows its source. But those States that are depicted in red are States that are actually in crisis. I am from New Jersey; it is red. The States that are showing the probability of moving toward crisis are in yellow and States that have stepped up to the bar and have done something about it are actually in white. I might note that in California--if we can look at the next chart, California is one of the States that did something about this problem. The red line indicates the national statistics and how this problem has exacerbated itself. We see that the increases that start during the 1970s were gradual at first, but as we move forward, the premium growth during the 1990s and now in the 2000s is just shooting upward. Contrast that with what happened in California, which is shown by the blue line. In the 1970s and 1980s, the costs of premiums for medical liability insurance began to increase. But in 1975, California enacted a cap. We can see that the premium growth stabilized right after that reform occurred, and we have not seen the kind of growth in California that we have seen nationally. So there are solutions apparently to this problem. [The prepared statement and charts submitted by Representative Saxton appear in the Submissions for the Record on page 29.] Thus, we want to thank Dr. McClellan for being here today to provide some insight into the problem and the direction of reform. Before we go to Dr. McClellan, we will turn to my friend, Senator Reed---- Senator Reed. Thank you very much. Representative Saxton [continuing]. ----Whom I might publicly congratulate. He got married last weekend, a great wedding at West Point, I hear. Senator Reed. For the first time. OPENING STATEMENT OF SENATOR JACK REED, RANKING MINORITY MEMBER Senator Reed. Thank you very much, Mr. Chairman, and thank you, Dr. McClellan. Welcome. On the campaign trail last year, President Bush repeatedly criticized trial lawyers for filing junk lawsuits that he said were responsible for rising health care costs. The centerpiece of the Administration's medical liability reform would cap non- economic damages at $250,000 and institute a 3-year statute of limitations on most lawsuits. The 2004 Economic Report of the President stated that the President's reform plan would lower the cost of providing health care. However, there is little, if any, evidence to support that claim. Hopefully, Dr. McClellan, you can shed some light on that. While it is certainly troubling that medical malpractice premiums for doctors have been rising rapidly in recent years and many physicians in my State have informed me of the cost burden and potential impact on access to care for patients, it is far from clear that jury awards are the sole driving force as the President suggests. In 2003, the Government Accountability Office studied States with and without caps on non-economic damages and found that the States with caps had lower premium increases than those without caps. However, GAO did not have enough data to show a direct link between malpractice award caps and premiums. Similarly, the Congressional Budget Office has found that there are potential savings for malpractice premiums by limiting the amount of malpractice awards, but they are skeptical that a cap would provide relief for health care costs in general. Malpractice costs were $24 billion in 2002, less than 2 percent of total national health care spending of $1.4 trillion, according to CBO. Reducing malpractice awards by 30 percent would only lower health care costs by approximately 0.5 percent, or about $7 billion. Granted, any lowering of health care costs would be an encouraging sign. CBO also finds that limiting physicians' malpractice liability would not have much impact on ``defensive medicine,'' such as providing unnecessary tests or procedures to avoid a lawsuit because physicians do so more often out of concern for patients or to generate additional income than because they fear liability. Dr. McClellan, I know you have studied the issue of defensive medicine and malpractice, so I will be particularly interested in your opinions about the amount of health cost savings caps on non-economic damages would produce. I believe, however, that there are some other reasons for the latest increases in medical malpractice insurance premiums that would not be addressed by the kinds of reforms the President is advocating. The GAO, for example, points to slower growth in insurance company investment income and reduced competition in the liability insurance market as other potential drivers behind rising malpractice premiums. We also should not lose sight of the fact that this issue must be considered in the context of medical errors and the quality of patient care, which are inextricably linked to physician accountability. A study by the Institute of Medicine reported in 2000 that between 44,000 and 98,000 people die every year because of preventable medical errors. These statistics point to a need to link any discussion of tort reform to the issues of medical errors, public safety and physician accountability. In the last Congress, the Republican leadership sent narrow medical liability legislation for OB/GYNs directly to the floor, thereby sidestepping serious committee deliberation and inquiry into the nature of and possible solutions for rising insurance premiums. While it is hard to see how the President's proposal for medical liability reform will make more than a dent in spiraling health care costs, this is an important issue that lawmakers must be allowed to investigate thoroughly. Again, your presence here today, Dr. McClellan, as the Chairman said, is an important step in this inquiry. I appreciate your willingness to testify. I hope you will also be open to questions regarding your oversight of CMS, which raises questions now and again. I have a number of questions regarding the $500 billion of Federal spending that you administer at CMS that undoubtedly has a bigger impact on physician behavior and overall health spending than medical malpractice costs. I look forward to your testimony. Thank you, Mr. Chairman. [The prepared statement of Senator Reed appears in the Submissions for the Record on page 35.] Representative Saxton. Dr. McClellan, welcome once again. I understand that your statement may take more than 5 minutes. That is fine. We have all morning. We are anxious to get started. You may begin, sir. The floor is yours. STATEMENT OF MARK McCLELLAN, M.D., Ph.D., ADMINISTRATOR, CENTERS FOR MEDICARE AND MEDICAID SERVICES Dr. McClellan. Mr. Chairman, thank you for this opportunity. Mr. Chairman, Senator Reed, Representative Hinchey, distinguished Members of the Committee, thank you for inviting me here today to discuss medical liability reform and, Senator Reed, congratulations, and I hope this isn't part of your honeymoon. As President Bush and many in Congress and across the country recognize, our current liability system does not serve the needs of patients and needs reform. It is not simply an issue of reducing health care costs by lowering the costs of medical liability. More importantly, it is about improving patient safety and quality of care. The Medicare and Medicaid programs are not immune from the costs created by our liability system. The Congressional Budget Office has estimated that if legislation the House has considered, and that you just mentioned, Senator Reed, were signed into law, it would result in savings to the Federal Government alone of more than $11 billion for the 2004 to 2013 period. But this figure only considers premium reductions. It doesn't take into account the far greater savings possible as a result of reducing defensive medicine. Peer-reviewed research that I conducted with Professor Dan Kessler at Stanford University found that capping non-economic damages and revising joint and several liability rules could reduce the practice of defensive medicine so that overall hospital expenditures would drop by between 5 and 9 percent. During fiscal year 2004, we spent more than $133 billion on hospital care in our fee-for-service Medicare program, and so that would translate to annual savings of between $6 and $11 billion. Other peer-reviewed studies have reinforced the importance of liability pressures driving broader cost increases in our health care system. Right now, Medicare faces a real challenge with physician payments. Spending on physician services during 2004 rose by approximately 15 percent from the previous year. As we work on solutions to the physician payment problem, we can no longer afford to pass by opportunities where there is overwhelming evidence of billions of dollars in cost savings without compromising patient health. For example, a significant driver of the past year's increase is the fact that more patients are receiving more complex and more frequent diagnostic imaging services. This is exactly the kind of medical practice that is aggravated by liability concerns. Doctors understandably worry about being sued for bad outcomes rather than bad care, since that is mainly what happens in our current system. Doctors worry about being sued even when they follow state-of-the-art medical practice because that is what happens. In fact, physicians get a double whammy. These liability pressures drive up costs without increasing quality, and because of the way our physician payment systems work in Medicare, when that happens, physicians get hit with reductions in payments on top of it. That can worsen the problem of access. We just can't afford to do this anymore. The problem is seriously aggravated by the disturbing recent trends in liability settlements and awards. Mr. Chairman, you put up some of the figures showing up through 2003, which were very concerning, but on top of that, the Physician Insurance Association of America, a main insurer of physicians for liability costs, has recently noted that the average jury award increased by 46 percent between 2003 and 2004, to over $439,000, and that includes an increase in the very large awards that you mentioned. So on top of the big increases in settlements and awards in the preceding years, I fear the quality and cost problems caused by our liability system will continue to worsen. With the new Medicare law and our proposals for Medicaid reform, we are taking many steps to support prevention-oriented care and promote better quality and safety, but it is hard to do that in an environment where legitimate worries about liability stand in the way of quality and safety improvement. That is the main reason we need liability reform through such proven measures as caps on non-economic damages. Liability reform will improve health care quality and access and costs, leading to better health for Americans. In saying that our liability system needs reform now, I want to be very clear that I fully support the goals of liability law. These are the right goals. Patients who are injured deserve to be compensated when they are treated negligently, and we need to provide strong measures to assure that physicians and other health professionals provide high-quality care and face consequences when they are negligent. But the fact is our liability system is failing miserably at both goals. For example, one of the most definitive studies, the Harvard Medical Practice Study, reported that, on average, it takes more than 5 years for an insurer to pay a malpractice claim after the date of the incident, and when an injured patient does finally successfully settle or win the case, the patient doesn't get most of the money. Even worse, only a tiny fraction of those who are injured due to negligent care get even this delayed and incomplete compensation, as you noted, Mr. Chairman. So in the system we have now, most of the money that is finally awarded goes to lawyers and to patients who were not injured negligently. These are the features of a long, slow and costly lottery. The liability system is not achieving its goals. Because doctors know they can and will be sued even when, in fact, mostly when they don't do anything wrong, it is no surprise that the result is higher health care costs and quality and access problems. The defensive medicine resulting from our liability system includes the costs and risks of unnecessary procedures, and it includes problems in access to care. In emergency care, in obstetrics, in neurosurgery and in other specialties in many areas of the country, as your chart showed, the result of high liability premiums and frustration over lawsuits is simply less access to physicians. And even if you can get access to care, it means higher costs. Our legal system simply does not serve the needs of patients and it does not encourage physicians to practice science-based, quality medicine. The evidence is clear that Congress could reduce health care costs and improve quality by passing legislation that puts in place reasonable caps on non- economic damages and revises the joint and several liability rules that encourage lawyers to collect several times over for the same damages. Such reforms would still allow patients to get very large recoveries for their injuries, including full compensation even for services like child care that do not come with a paying job. There are other steps that can be taken, as well, that would also help our liability system do what it is failing to do today, without adding unnecessary costs or compromising quality of care like the current system does. For example, in late 2004, the Department of Health and Human Services announced a voluntary early offers program. Under this program when someone files a claim against the department, for example, for care in a community health center or through the Indian Health Service, HHS will evaluate the claim and then send that person a notice telling them about the option of using an early offer. Then both sides have 90 days to submit a confidential settlement offer to an independent third party. If the offers match or they overlap, the case is settled and HHS immediately pays the amount requested with much more of the money going much faster to the injured patient. If there is no match, the case can proceed as usual. The goal of this program is to do what our liability system is failing to do, provide prompt and predictable settlements for injured patients without the delays and the uncertainty of trying to go to court. And these patients will not have to turn over a large part of their settlement to their lawyers. We need to support more steps like this. Some time ago, Johns Hopkins Hospital began requiring non- emergency patients who came to them for elective procedures to sign an agreement to take any malpractice claims to mediation prior to going to court. In 2003, 24 cases went to mediation and 21 of them were resolved promptly. As a result, the experience for Hopkins Hospital in 2003 claims decreased in expense by almost 30 percent. Mediation is typically much faster than a court case and involves far lower attorneys' fees. In short, patients who are injured get compensated at a higher level and in a shorter amount of time. Costs are lower and more predictable, improving the delivery of care. We are looking at ways to encourage such steps toward better compensation and lower costs to the liability system in the Medicare program. For the sake of our patients and for quality of care, we can't afford to pass up these opportunities anymore. Another promising idea is the establishment of special health boards or courts devoted to hearing cases involving claims of medical malpractice. These specialized courts would employ specially trained judges with health care expertise and background and would deal only with liability cases. Judges could be selected through a non-partisan process. Their expertise and impartiality would provide the predictability, the timeliness and the fair compensation that simply don't exist in our current system. Besides looking at opportunities to provide a better compensation system for injured patients, we are also taking many steps at CMS to help patients actually get better care. This includes new systems for reporting information on the quality and safety of care in hospitals, in nursing homes, in home health agencies and, soon, in ambulatory care as well. It includes quality improvement initiatives and more coordinated work with State oversight agencies. These are effective ways to increase provider accountability. I am also pleased about the bipartisan congressional interest in patient safety legislation that includes a mechanism for allowing anonymous reporting of errors and risky situations, and anonymous systems to help prevent those errors in the future. It protects these badly needed data from discovery. We don't have as much of this preventive information as we should because health professionals rightly fear that it would be used not to improve quality, but as the target of a fishing expedition for lawyers. The same concerns are slowing the adoption of electronic health information systems that can improve quality and safety. As the Institute of Medicine has noted, if we don't take these steps, we will keep missing opportunities to improve patient safety and quality. Mr. Chairman, we are increasingly using performance standards in our health care system. We need to subject our liability system to this same kind of performance review. Its very low levels of performance in terms of compensating injured patients and encouraging quality care mean that it is blocking progress toward better care. The current medical liability system is not meeting the needs of patients and it is costing those patients and the Federal Government and other payers billions of dollars because it causes unnecessary care and problems in access to care, and it is providing no reliable compensation to patients who are injured. We know how to do a lot better and we are looking forward to working with you toward liability reforms that improve quality and access to care and reduce health care costs. I would be pleased to take any questions that you all may have. [The prepared statement of Dr. McClellan appears in the Submissions for the Record on page 36.] Representative Saxton. Dr. McClellan, thank you very much for an excellent statement. Let me begin by referring to something that you alluded to and that I mentioned in my opening statement. It is quite surprising to me to find that a large majority, according to some studies, of doctors who have been subject to lawsuits--that something in the neighborhood of 80 percent of the medical liability claims don't involve negligent injuries. This has been something that I have found hard to understand. In fact, as I pointed out in my opening statement, one study found that more than half of medical liability claims don't involve any injury at all. Can you talk a little bit about this and explain how this can be and what kind of a problem? It is obviously a big problem. Dr. McClellan. Mr. Chairman, your figures are right. They are drawn from studies like that Harvard Medical Practice Study that took a systematic look at the cases that were coming to court. They reviewed all of the cases over a certain time period in some specific States or a large sample of cases, including cases in New York, and they found the kind of results that you are talking about. And other follow-up studies have yielded similar results, that very often cases are brought when there are bad outcomes, even if there was no medical negligence involved, and very often there may not even be actual harm demonstrated. It may be a claim that the patient was perhaps someday at risk of harm even when, again, the physician has followed appropriate medical practices. The system that we have now does not screen out these kinds of cases. It doesn't encourage us to focus, most importantly, on cases where there has been true negligence and, as a result, doctors should be held accountable. If we did a better job of that, we could compensate the patients who are truly injured negligently much more effectively, and we could provide more predictability to the doctors. They wouldn't have to worry that when they are providing care that is up to standards and doing what they think is right from the standpoint of their medical expertise, they will be able to practice appropriately. They won't be hauled into court for it. Representative Saxton. How did these studies arrive at the conclusion that all of these cases did not involve any negligent behavior? Dr. McClellan. They involved a kind of medical review that ought to be a more systematic part of our approach to medical liability and medical negligence. They had independent expert reviewers, multiple reviewers, look at all of these cases, look at all the documentation and reach conclusions about whether appropriate medical practice was followed or not and whether the alleged injury was, in fact, from a medical standpoint, related to the actions of the doctor. It is that kind of expert involvement that we don't have in our liability system today. Representative Saxton. Of this large percentage of cases that don't involve negligent injuries, do many of them result in awards to the claimant? Dr. McClellan. Yes. Most of the awards that do occur are for cases where there was no negligence by the physicians. A lot of these cases end up being dropped or end up being settled for little or no money; but many of them do end up in large settlements, and even in the cases that don't end up giving money to the plaintiff, they do end up taking a lot of time and effort on the part of the doctor and the doctor's medical staff, and they do end up with a lot of the money going to the lawyers that are involved. Representative Saxton. On the other side of this coin, I am told it is widely recognized that only a small fraction of negligently injured patients file a claim. How can this be so backwards? Dr. McClellan. Well, it is a very difficult system to navigate because the costs are so high, and it takes so long, and there is so much burden. There is a burden on the doctors. There are also burdens on the patients for going through this long process. A lot of them don't bother with the effort. That is why I think that some of the steps that I outlined in my written and my oral statements are so important. If we can take steps to take these out of the court system, that is a 5-year-long process that has a lot of burdens along the way, and have a quicker approach, like this Early Offers system that I mentioned or approaches that rely on mediation, I think more patients who are truly injured negligently could get compensated, and more of the money would actually go to them. It wouldn't go to the costs of administering this very long and complicated system. It wouldn't go so much to the lawyers involved. Representative Saxton. So to conclude this point, I guess, there are a large number of people who receive, for lack of a better term, negligent treatment who are not compensated, and there are a large number of people who receive very adequate, non-negligent treatment who get compensated. Dr. McClellan. And then a lot of money goes to the lawyers in the process, at least 30 to 40 percent of any settlements that occur. And then there are other administrative costs for the lawyers on the other side, the courts and so forth. Most of the money in the system doesn't end up going to patients, and you are right that only a very small fraction of it actually goes to patients who are injured negligently. Representative Saxton. Now, of course, I am not a doctor; but I am a human being, and if I were a doctor, it would seem to me that I would go to my practice each day with a list of things that I needed to do, and perhaps one of the most important--maybe the most important--is to protect myself from potential claims. And if I were a doctor, not being one, how would I do that? Dr. McClellan. Well, there are steps that you could take to protect yourself from claims. I think people who have studied this issue talk about positive and negative defensive medicine. ``Negative defensive medicine'' is that you just stop taking the cases. If there are high-risk procedures, cases where there is some real chance of a bad outcome, like in neurosurgery or in obstetrics or in some types of emergency care, there are many doctors who are just leaving those practices. I have talked to physicians in different parts of the country, the Mississippi Delta, the Las Vegas area, parts of Ohio, Pennsylvania, other parts of the country where there are now real access problems, particularly for certain kinds of specialties and certain kinds of procedures from doctors just staying away from them. It is not worth the risk. They can't afford the insurance. They don't want to go through the hassle when they are practicing good care. On the other side, so-called ``positive defensive medicine'' costs, or extra tests and extra procedures that might be ordered not because that is what the medical guidelines say, but just because a doctor wants to be protected in the event of a suit being brought, that is where we see maybe extra cases of imaging procedures being done. I talked about some of the rapid growth we have seen in the past year in the Medicare program, in the use of advanced imaging procedures that are very costly, and in some cases, when a patient comes in with a headache or another problem like that, that just aren't medically warranted. So we would like doctors to come to practice every morning thinking about, ``What are the things that I can do today that are going to do the most for my patients at the lowest cost?'' This system creates some very different kinds of pressures on how they make their decisions. Representative Saxton. Your answer reminded me of an incident that occurred in New Jersey. We have neurological physicians, of course, in New Jersey. At one time we had around 90. Now, I understand we have less than 60. One of the hospitals that lost their neurological surgeon had a need for one. A lady was admitted to the hospital and there was no neurological surgeon to treat her. So they literally had to get a helicopter and fly her across the river to Philadelphia for treatment. It seems to me that that would create a situation where people don't actually have access to proper care. Dr. McClellan. It is. On the one hand, it is higher cost because she had to get all that extra transportation. At the same time, it is worse quality of care. Many neurologic procedures are urgent. The transportation time, the disruptions that can occur in moving a patient can compromise quality of care. And so from both a quality and a cost standpoint, it is a real problem. Representative Saxton. On the positive side, the things that you referred to as positive steps that can be taken, I suspect that very thorough examination and testing would be a way to protect myself if I were a doctor. Dr. McClellan. That is right. And very thorough examination and testing is appropriate in many medical cases. We want doctors doing a thorough job of working up a patient appropriately, according to the latest medical science. But their decisions ought to be determined by the medical science, not the latest court verdicts where doctors are being sued successfully. So often when there hasn't been any actual medical negligence, when they are being sued unsuccessfully in a lot of cases where there is no negligence--but they still have to be dragged into court, it still takes a lot of time and effort, it still adds to their liability cost--you end up with different kinds of pressures on the way the doctors are practicing. And that is what we would really like to avoid. Representative Saxton. It seems to me that one of the downsides of doing too many tests would have to do with expense. That goes without saying. You do tests that are, quote, ``unnecessary'' to protect oneself, the doctor. It is going to cost more. Any other downsides? Dr. McClellan. You can get into a vicious cycle. Very often when these imaging procedures are done, there may be an anomaly on the test. No test is perfect. No test is right 100 percent of the time. If you are doing a diagnostic test on a patient that has got a very low likelihood of actually having a real problem and you see something anomalous, probably in many cases it is just going to be the fact that a test isn't perfect. But if you see that, if you have done the test in part because of liability pressures, you are going to have to do something else about it. So you may end up in a situation where you are going just from ordering an MRI to then having to go on to further workup of a patient, a biopsy procedure, other types of services that carry with them their own risks and potential for harm and additional costs. Representative Saxton. A large percentage of the American population pays for medical care through Medicaid and Medicare. It seems to me that since older folks, in terms of Medicare, receive a very large percentage of medical treatment in this country, for obvious reasons, that there would be a particular concern with regard to the implications for Medicare and Medicaid. Can you speak to that subject? What does it do to the system that you oversee? Dr. McClellan. When you take account of these defensive medical costs, it means higher costs in a couple of ways. One is the higher costs associated with the extra procedures, the extra tests and so forth. Another is the higher costs associated with complications of problems of access to care. If patients can't get access to the neurosurgical services they need, or the emergency services or other problems, that can lead to higher costs as well. It certainly leads to quality problems. Some of the studies that I have been involved with, these peer-reviewed studies published in academic journals, suggest that we could have an impact on Medicare costs of 5 percent or more, at least for hospital costs, by addressing these defensive medicine problems, by reforming our liability system. Even if you are only looking at the direct costs of the higher liability premiums and the costs of the liability system itself, again money that is mainly not going to care for patients and not going to compensate patients who are injured negligently, even there you can save billions of dollars in program reforms as that CBO study that Senator Reed mentioned documented. There are real opportunities for lowering costs, and that is something that we need to be paying a lot of attention to right now when we are struggling to find ways to pay our physicians appropriately, and when we are trying to take steps to make our program as sustainable as possible. Representative Saxton. Tell us about the effect on the Medicare trust fund. Dr. McClellan. The savings that these reforms would engender, the billions of dollars in savings, according to CBO estimates, the even larger savings that could result from really doing something about defensive medicine, would assist the trust funds. That would reduce the pressure that the trust funds are facing. I won't say this is the only step that we need to take to make sure Medicare is sustainable. We also need to bring our benefits up to date and take other steps that promote higher- quality care as I talked about. But we really want to create an environment that encourages high-quality medical practice and that avoids unnecessary costs, and the liability system that we have today is standing right in the way of that goal. Representative Saxton. One of the answers to this problem appears to be something that is referred to as ``caps on non- economic damages.'' These caps have been touted as an important element of effective medical liability reform, and I referred to the one chart. Maybe we could put that chart back up again, the one that is right there in the front. That is good. The national average for premium growth since 1976 up until 2003 is demonstrated here by this chart as a relatively flat line in the case of California, which enacted caps in 1975 and a very steep inclining rate of growth for the national average. I am told that Kenneth Thorpe of Emory University recently--and incidentally a former Clinton Administration health official--came to the conclusion that premiums in States with a cap on awards were significantly lower, as is depicted by this chart, than States without caps. Would you discuss this? Dr. McClellan. It is not just Dr. Thorpe's conclusion. It is also the conclusion of studies that have been done by the policy and evaluation office in the Department of Health and Human Services. It is the result of studies that we have done and that have been published in peer-reviewed academic journals before I came to work in Government. It has been the result of other studies by other distinguished economists and health policy researchers. From these studies, together they show that these kinds of caps on non-economic lead to changes in physician behavior because the physicians feel less pressured to deal with liability and more focused on providing care for their patients. They lead to lower costs of defensive medicine, as we have already talked about a little bit. They lead to lower liability premiums because they reduce the costs of our liability system. And they lead to greater access to care. A recent study by the Agency for Health Care Research and Quality showed that in States that have implemented these liability reforms, they have a significantly larger number of physicians in practice. So you have less situations like the one that you described in New Jersey where a patient can't get access to the care they need. Representative Saxton. If caps were successful in bringing about these changes in medical care and the performance and activities of physicians, would it also be fair to say that it would have the effect of reducing the costs of the actual premiums charged to doctors? Dr. McClellan. It would have a direct effect on reducing the premiums; that is correct. The beneficiaries in the Medicare program pay a quarter of the costs for Medicare Part B, and that is the cost of physician services and all the other outpatient services, including all those imaging procedures and lab tests and so forth. So it would have a direct effect on premiums. Representative Saxton. Would it have an effect on the cost to the consumer? Dr. McClellan. It would also have an effect on the cost to consumers. Not just because of lower premiums, but because if they are undergoing fewer tests, if they are getting medical care that is practiced more efficiently where they can get the relief they need for their health problems at a lower cost-- that is, lower copays, as well, and lower out-of-pocket payments for that reason, too. Representative Saxton. In your opening statement you mentioned--along with caps for medical liability tort reform involving caps on non-economic damages, you also mentioned mediation. Dr. McClellan. Yes. Representative Saxton. Would you explain the effect of how you see mediation working? Dr. McClellan. Mediation is just a better environment for getting to resolution of issues in a way that reflects the medical science. Mediation is led by an independent expert, someone who knows the field of medicine and who is not on one side or the other, who can work to try to bring the different sides together. I mentioned the Johns Hopkins Hospital case where now this is mandatory for patients who are coming in for elective non- urgent procedures. They have time to think about whether they want to get care this way, and mostly, generally, they decide that they want to. The cases--if there is a problem of a bad outcome or other dispute, go to mediation instead of going straight to a court in that long, 5-year-or-longer, lottery to get to resolution. The mediation can take place in a matter of a few months because there is less court time and less lawyer time involved. The money involved in the mediation settlement goes to the patient who is injured, and because you have got an independent expert involved in getting to a conclusion, you are more likely to reflect the actual medical facts and have a decision that is predictable based on what medical science says it should be. Representative Saxton. I apologize to Senator Reed. I have one final question and then we will go to Senator Reed. We know that the medical liability crisis has not hit all specialties in the same way. Obstetricians, orthopedic surgeons, neurosurgeons and radiologists have been hit particularly hard. It would seem that the higher premiums charged to these specialties would have an impact on which areas of the medical profession students choose to enter. So the question is fairly obvious. Looking down the road, do we see any problem in finding specialists in certain areas that are especially hit negatively by this medical malpractice situation? Dr. McClellan. It is certainly a concern. When I talk to my colleagues who are still in academic medical practice, they note that this is having an impact on student decisions. That will have consequences down the road. But I think even more worrisome is, it is having some consequences now. I have talked about some of the evidence on different levels of access to physicians in conjunction with whether or not a State has reformed its liability system; and as you put up on your chart earlier, there are areas of the country where physicians are leaving practice, particularly in these specialties, where they are not taking the more complex cases in these specialties right now. So this isn't a problem that is just down the road, that will be aggravated by the decisions that medical students are making today about specialties to avoid because of liability concerns; it is a problem right now in many areas of the country. Representative Saxton. Thank you very much. Senator Reed. Senator Reed. Well, thank you, Mr. Chairman. I wonder if we could have a second round, and I can limit my questions and allow my colleagues to ask their questions without an extended period. Thank you very much, Dr. McClellan, for your testimony and for your work. In fact, back in 1996, you and Dr. Kessler did a path-breaking study of the effects of defensive medicine. You estimated the costs to be somewhere between 5 and 9 percent. Others have looked at the same issue, CBO for one, and have not found as great an impact. Do you have any insights as to why CBO would find a much less---- Dr. McClellan. Senator Reed, I know you pay a lot of attention to these economic issues, and I appreciate the question. We had a little bit of discussion of this in my written testimony. When CBO looked at the same conditions we did, they found similar results. So looking just at heart disease--these are pretty well defined cases. There is an event that occurred, a patient having a heart attack or other serious heart problem, then we tracked after that. When CBO looked in the same way, they found the same kinds of effects. But the problem with the CBO study is that it also looked at other types of cases, just sort of the overall population of patients; and that is a very heterogeneous set of patients, some of which have certain diseases, others have other diseases. And there are a lot of things that influence costs of care in these patients and their outcomes of care. And so, in economic terms, that means this is a noisier or less precise estimation situation. They also had only a proportion of the cases, not the whole larger sample that we looked at. And so it is probably not surprising that they didn't get to as statistically significant results. The other thing is that in the cases that we were looking at, these were cases where people were already getting care. They had come into the hospital with a very serious medical problem. In the cases that CBO looked at, they would also pick up cases where people may not get treatment. Remember, there are two kinds of defensive medicine. There is defensive medicine that leads to higher costs and perhaps a worse outcome, and there is also defensive medicine where the doctors just don't take the cases, that leads to less access to care. They probably were mixing up some of both. There may well be some, quote-unquote, savings from doctors not seeing patients. But I am not sure that is a good thing. The bottom line, though, is that CBO concluded, as you mentioned earlier, that reforming the liability system would save Medicare billions of dollars. We can argue about what the magnitude of those savings should be, but there is no question, all these studies say ``significant savings,'' and that is something that I think is really important to take advantage of. Senator Reed. But your study was more precisely related to those heart procedures? Dr. McClellan. Those heart conditions, right. Senator Reed. That is where you would see that, based on your---- Dr. McClellan. Potentially in others. I think there have been some other studies done of care for patients with other particular conditions, obstetrical conditions, deliveries, where you see similar kinds of effects. More use of Cesarean sections, for example, in States that haven't reformed their liability systems. When you look at particular types of illnesses where we can really define the cases clearly, there is not this big heterogeneity problem. You tend to see effects. Senator Reed. One of the other measures of whether this works or not is what the actors in the economic system do. Interestingly enough, in Texas, which adopted caps on non- economic damages, GE Medical Protective, a large insurer, made a regulatory filing where they estimated that capping non- economic damages will show loss savings of 1 percent. Again, 1 percent of a big number is real money, but they requested a premium increase of 19 percent 1 year after Texas capped their non-economic damages. One of the assumptions implicit in most of the discussion we had this morning is that if you cap non-economic damages, you will reduce premiums for malpractice insurance. Here is a situation where they are asking--and they are economic actors looking at their costs--for a significant increase and they estimate that there is a saving from the cap, but relatively small. What is going on down there? Dr. McClellan. Well, I think they are looking at the so- called ``direct liability costs'' or this impact on liability premiums, and there are other savings that would come from the impacts on defensive medicine. That is not something that the liability insurer is actually going to see. That is something that our health care system is going to see as a result of differences in medical practice. But as you have said, a percentage point reduction in medical spending, that is still real money, and in a big health care system, that is still billions of dollars. They also are facing price increases in Texas for other reasons. That Texas liability reform didn't do everything that I think the kinds of damage caps that we have talked about would do. But just to put this in perspective, if you look at the 75-year actuarial deficit for the Hospital Insurance trust fund, that is, the Medicare Part A trust fund that people are really concerned about because it is scheduled to become insolvent in 2020, we could get rid of two-thirds of the 75- year deficit by reducing the rate of growth in medical spending by 1 percentage point. So if we change the way medicine is practiced, even if it is incremental, it really adds up to savings over time. Senator Reed. Let me focus on the point that there is an implicit assumption that if you cap medical non-economic awards, you will reduce medical premiums; and here you have a company who is saying, ``You've done that. Terrific. Now give us a 19 percent increase.'' I would also suggest, as many others did, that the California experience was shaped not just by the 1985 law capping damages, but by the 1988 law that actually imposed limits on the increasing size of malpractice premiums. Dr. McClellan. As you saw from the chart, the slowdown in growth started before 1988, and it has continued well after. Senator Reed. But my point with respect to the premiums that physicians are paying is that the result was not simply the adoption of caps on non-economic damages, but also limits on malpractice premiums. Would you support, in conjunction with a proposal for tort reform or insurance reform, putting caps on insurance premiums? Dr. McClellan. I certainly want to see how such a proposal would actually work. If you put caps on premiums, but don't change the liability system, for example, you will end up with insurers not being able to cover the rapidly rising costs of claims that we are seeing. If you look at the claims growth in recent years, including that 40 percent increase that I mentioned between 2003 and 2004, you are going to end up without liability insurance and then you are really going to end up with doctors out of practice. Senator Reed. But the other side of the equation is, if you cap non-economic damages, but don't put any limits on insurance premiums, you could have the situation as there seems to be in Texas with GE Medical where they get the benefit of the law and they still ask for a 19 percent increase. That, I think, would be unfortunate because, again, a lot of this debate is being driven by the implicit and sometimes explicit assumption that if you cap damages, you lower premiums to physicians and hospitals and other health care providers, and they go on their merry way. Which raises the other issue behind why premiums are going up, why medical costs are going up, and that is the technology, allowing increased procedures. It is interesting. You mentioned the diagnostic imaging procedures. I had my radiologists from Rhode Island in. Their major comment--I won't say ``complaint'' because they never complain--their comment was internists, general practitioners are now getting very good, digitized equipment to do radiological procedures. It is not the old bulky kind that required a little more practice and training. It is secondhand equipment, though it is still adequate; and because they are under acute pressure in their offices to generate income, they are doing tests which before they might not do. Because it is so easy to do it, they can step in the next room and now give you a little scan with their radiological equipment. How much of these costs and these increased procedures are being generated by access to technology and the pressure, because of the way we pay people through Medicare, to generate these procedures to get more income? Dr. McClellan. Senator Reed, I think you are right that the way that we pay in Medicare also doesn't necessarily focus on getting the best-quality care at the lowest cost. We are having some discussions right now with the radiologists, with other medical groups, about how we can get to a better system, where our payment rules are focusing more on supporting doctors, delivering high-quality care at a low cost. I would be delighted to continue to work with you on that issue. But I think the fact remains that you are right, that it is easy now for physicians to obtain this imaging equipment and to bill for it. But the liability pressures on top of that are just going to encourage that even more. So I think we should be looking at better ways to formulate Medicare payments, to support and reward doctors that are really trying to do the right thing. But we can also do that by reforming the liability system. If we do both together, we are going to have a much better effect. Senator Reed. Again, I think what your comments suggest and what my instincts are is, this is a multifaceted problem requiring multifaceted approaches. But we seem to hear the Administration use one approach, which is basically, if we just rein in those junk lawsuits, everything is fine, when in fact I think you would concede, we have a complicated medical delivery system that has all sorts of different incentives and disincentives. Dr. McClellan. That is true, but I also think if we rein in the lawsuits, we will get higher-quality care, better access and lower cost. There are other things that we should be doing to achieve that goal as well. I hope we can work together on them, too. Senator Reed. Well, Mr. Chairman, again I think this is very productive. I appreciate Dr. McClellan's presence. But I would--in lieu of a second round, let me just stop and let my colleagues go. Representative Saxton. Mr. Hinchey. Representative Hinchey. Good morning, Dr. McClellan, thank you very much for your testimony. The licensing of professionals, including medical professionals and specialties in medicine, and the regulation of those professions is an activity that is carried out by the various States. And various States, as we have seen in one of the charts, have taken various steps over the years to deal with the problem of medical malpractice, including the regulation of lawsuits, as well as other steps. Why is this a Federal issue? Why should the Federal Government be involved in trying to limit people's access to the courts? Dr. McClellan. Two reasons. One is that the Federal Government is involved in providing access to medical care for these individuals. In our Medicare programs and our Medicaid programs, we are the primary insurer. And how we provide this care, how we provide the support for medical care, makes a big difference. So I care a lot about the quality of care that our beneficiaries are receiving. And I also care a lot about the cost of these programs. I want to make them as sustainable as possible so that Medicare beneficiaries and Medicaid beneficiaries, who really need our help, can get the greatest help possible, can get the best access to up-to-date treatments that are really making a difference in their lives. When I look around the country, in these States that haven't reformed their liability systems, seeing a lot of the money going into areas that are unnecessary procedures and that are problems in access to care, I really think we can do better. Representative Hinchey. I think we can always do better in every field. But I still wonder why the Federal Government should be putting itself into this situation when it is, traditionally, for all the time in our history, that we have left this particular situation to the States to deal with, to regulate, and they have done so in various ways. So I am not convinced that just because we have Medicare, we should be stepping in to try to limit people's access to the courts. But I do agree with you that we ought to be doing everything that we can to try to reduce the cost of our health care services. I am wondering if you could tell me how much money we would save if, say for Medicare particularly, if you were allowed to negotiate with the pharmaceutical companies for the cost of prescription drugs. Dr. McClellan. Well, that is a very good question, one that there has been a lot of interest from Congress and the public in. For that reason, I have been asking my actuaries, our independent actuaries that do these forecasts of Medicare costs, about what the impact would be. And I can send you a copy of the letter that my chief actuary, Rick Foster, sent to me on this very topic back in February. What he concluded was that negotiation by the Federal Government, on top of, or instead of, all of the negotiation that is going on right now as we implement the Medicare drug law to get the lowest possible prices to seniors--that additional negotiation would not lead to significantly lower costs and could potentially cause problems in access to care. So the reason for that conclusion is that people have looked at what happens when the Government does step in and regulate drug prices. In Medicare, what we saw before the Medicare law was passed was prices that were higher, much higher, than can be obtained in a competitive system for the drugs that Medicare covers now under Part B. They have looked at problems that could arise in access to care. The way that the Government could potentially negotiate is by saying, people won't get these drugs unless you give us some kind of lower price. And the result would be problems in access to the drugs. I think it is very important, as we implement the Medicare law, that people have access to the medicines that they need, that they can get the drugs that best meet their needs. So for those kinds of reasons, our independent actuaries concluded that this wouldn't lead to more savings. The independent analysts at CBO have reached a similar conclusion as well. Representative Hinchey. Well, I would like very much to see that letter. Dr. McClellan. I will send it right along. [The information referred to can be found in the Submissions for the Record on page 44.] Representative Hinchey. Sometimes independent actuaries turn out to be not quite so independent as you would like them to be. Dr. McClellan. I think ours have a pretty good tradition of speaking what they think is right. Representative Hinchey. I would like to see the letter to see what the conclusions were that they drew. And particularly in light of the fact that in every situation, in every country where you have a system of health care, national health care, and the price of pharmaceuticals are negotiated by that organization, the prices of drugs are very, very much lower than they are here, every single country. Dr. McClellan. Well, it is true for some new drugs. I don't think it is true across the board. And it is certainly not true for the generic drugs that make up a majority of the medicines that people use in this country. When you put price regulations on generics, you end up with higher prices, so what we see in these other countries that you are mentioning is they may have some lower costs on the new drugs that they have access to, but they do not have access to as many as we do. But they have got higher drug costs and less access to generics, and the result is, they are spending money in a way that does not lead to the best value for their citizens. Representative Hinchey. That is not true in the case of Canada, for example. And the Canadians have access to every single drug that we have access to. Dr. McClellan. We will give you the specifics on that too. But there are a number of drugs that are available in the United States that haven't been available or are available with a significant delay in Canada, and you have to go through a Government system for access to many drugs, including proton pump inhibitors, AIDS drugs. There are some drugs that are non-preferred or off formulary in Canada. There is a study. We will get all of the specifics; I don't have them all at the tip of my tongue. But there is a study done by, again, the Assistant Secretary for Planning and Evaluation that documented all of these back in 2002. But there are AIDS treatments that were available only after substantial delay, compared to the United States, and many of the drugs that are available in Canada you have to go through Government processes in order to get. And the generic drugs in Canada do average about 40 to 50 percent higher in price than the drugs here. And generics account for most prescriptions in the United States. Representative Hinchey. Well, I have never heard that before. That is an interesting point. Dr. McClellan. We would like to follow up with you. [The information referred to can be found in the Submissions for the Record on page 46.] Representative Hinchey. When you look at the overall cost of prescription drugs, not generics specifically, but generics included in the overall cost of prescription drugs, the cost of those drugs is substantially lower. That comes about as a result of the fact that the agency in charge of the health care system there, such as Medicare, has the authority to negotiate with the pharmaceutical companies, and therefore they are able to bring down the cost of those drugs specifically. So you have looked, outside of this letter from the actuaries, at the benefits that might accrue, the financial benefits, if you were able to negotiate? Dr. McClellan. In the process of passing the Medicare law, there were a lot of discussions about this in Congress, as you know. Subsequently, as we have implemented the law, we have asked repeatedly, What is the best way to achieve two goals? One, we want to get prices down for drugs as much as possible for our seniors; and two, we want to make sure that seniors have access to up-to-date medicines. What we have seen too often in Medicare, where we have relied on Government regulation and statutes only, rather than giving people access to choices about how they get their coverage, is, the benefits fall way behind. We have fallen way behind in prevention, we have fallen way behind on assistance for people with chronic illnesses and preventing complications. We have fallen way behind on prescription drugs. So the steps that we are taking, as reflected in that actuarial letter, are the ones that are going to get us the best access to medicines and the best prices on those medicines at the same time. We need to achieve both goals. Representative Hinchey. Well, I look forward to reading that letter. When do you think you can get it to me? Dr. McClellan. Today. Representative Hinchey. There is another aspect to this, too, of course. And the availability of drugs does not mean that they are available to everyone. There are many people who cannot afford drugs that become available. And so the consequence is that they are not able to take them; it is not likely that you are going to have access to those drugs. There is just one other thing that I would like to ask in this particular round, if I may, and that is that many of the studies that I have seen that have been conducted by States indicate that a small portion of the medical profession is responsible for most of the malpractice cases and actions. And some of those doctors, if they are convicted of medical malpractice in one State, move to another State. Do you think it would be an idea that we might pursue to have someone form a Federal oversight of physicians who are guilty of malpractice and who seek to escape that by moving to other States? Dr. McClellan. I think having better information available on the quality of providers, including physicians, is really important. And we are taking a lot of steps to make that happen right now. We started reporting information, for example, on the quality of care on just about every hospital in the country. We started that a month ago. We are going to expand that. We are going to make this work for ambulatory care, as well. So I think steps in the direction of providing better information so we can identify potentially problematic providers is very important. But in terms of the cases that are actually brought, while only a relatively small share of doctors are sued frequently, in the specialties that we have talked about before, in OB, neurosurgery, most doctors have been sued at least once, if not more often. And that gets back to this lottery problem that I talked about. Sure it would be nice to find a system, better ideas for targeting those really problematic physicians that are a small part of the total. But most doctors are being sued. Our current system is not doing a good job of targeting in on truly bad physicians. Representative Hinchey. True. Representative Saxton. If I may, if we can go to Mr. Cummings, inasmuch as we are going to have a vote. Representative Cummings. Thank you very much, Mr. Chairman. Doctor, I want to pick up where you just left off. You say that most physicians are sued. And I am just wondering, there have been a number of proposals that there be more of a screening process early on to eliminate the so-called frivolous cases. Do you think that would help? Dr. McClellan. I think it could help. And as I mentioned earlier and was talked about in my written testimony, right in Baltimore at Johns Hopkins Hospital, they have this automatic, or this required, process to go to mediation first for elective cases, you know, where the patient has a chance to think about it and signs a form before they get care at Hopkins, saying that they are going to mediation first. And that works. The vast majority of complaints that are brought, get settled quickly and effectively through mediation. They never have to go to court. Mr. Cummings. And as one who--I support Johns Hopkins, of course, I have a lot of constituents that work there. But Johns Hopkins has had its share of suits, too, sadly--I mean, that have been--I mean, with substantial awards; and in some instances, they basically just about admitted liability from the very beginning. I can think of two right off the top of my head, and cases of death. And that is not knocking Johns Hopkins, because it is a great institution. But even in a great institution like Hopkins, things do happen. I guess, as I sit here and I listen to my colleagues and I listen to you, I cannot help but think about something that my good friend, Senator Obama, talks about; and he talks about an empathy deficit in our country, an empathy deficit. You have got the California law that puts a $250,000 cap on economic, non-economic loss. That was enacted, when, in 1975? Dr. McClellan. Right. Mr. Cummings. Do you consider this the gold standard for what the country should be doing? Dr. McClellan. I think it is one important step the country can take to get better quality care, better access and lower cost. There are other things that we can do as well. Mr. Cummings. Let's talk about the victim for a moment. I do not what kind of house you live in. But if you bought a house 30 years ago for $50,000, I would hate to think that now, today, 30 years later, it is still valued at $50,000, you could just sell it for $50,000. And I was just wondering, do you think that that figure is a little low, considering it is 30 years old, the $250,000? Dr. McClellan. We can talk about what the figure is. When I think about these cases of damages, what I look at is the overall compensation that the victim receives. And the costs for raising a child, the cost for losses on the job, the cost for other services performed around the home, even for someone who is not working, all of those costs are fully compensated in this kind of system. And those numbers have been going up and up and up, along with the economic costs, along with it. And if the costs of a house--those are determined by economics. The costs of wages, the costs of providing for your child, the costs of caring for your child, those have real economic implications; and those can all go up over time. Representative Cummings. My point is, so you would expect-- we can be 100 years from now and we are still at--in other words, at the time that they passed the law, they must have felt comfortable about $250,000 and what its value was at that moment. I understand they haven't changed it. But my point still remains, I just used the house as an example that things do go up, we consider it. There is nobody sitting in this room that would accept the same salary they received 30 years ago, today; they would not do it. Nobody. And I know that salary, given inflation and other things going up, people expect it to increase. And I am just curious, considering that, does it make sense to leave the non-economic damages cap there, considering what I just said? Dr. McClellan. Well, again for salaries and other things like that, those go up with the costs going up in the economy. That is not subject to the cap. Representative Cummings. You are still missing my point. My point is, do you leave it at $250,000 thirty years later. Dr. McClellan. Again, if you are looking at a system that can lead to lower costs without causing problems with access to care, this is definitely something that can do it. If I can say just one thing, and I have heard Senator Obama talk about the empathy deficit too, and I think the real concern here is that patients who are injured negligently just have no chance really in the court system. Only a very small fraction of them are actually able to bring cases all of the way through this very long and complicated and costly process. Those that do make it through, most of the money goes to lawyers, they don't get any compensation until years after the event has happened. We ought to be able to do much better than that. The system is failing in compensating people who do deserve compensation for their negligent care. Representative Cummings. Well, Mr. Chairman, I know we have got a vote. I will follow up with some written questions. Representative Saxton. We do have a vote on a rule for consideration of the budget report. So we are going to recess for a few minutes. We will recess for about 15 minutes. [Recess taken.] Representative Saxton. Dr. McClellan, first of all, I apologize. Nothing I can do about it, obviously, when we have votes. But I apologize to Senator Reed, too. I think that Senator Reed may have a couple of more questions. So let us go to Senator Reed. Senator Reed. Thank you, Mr. Chairman. Dr. McClellan, just a couple of follow-up questions. One is a point that Mr. Hinchey made. One would like to think that every physician in the United States is excellently prepared, trained, unburdened by the woes of the world, et cetera, but that is not the case. In fact, you can probably posit there is a normal distribution of skills and of temperamental characteristics. It is not surprising, then, that there is a portion on one side of the curve that seems to be involved in lots of issues of medical malpractice. Has anyone done an estimate, since we are talking about what we can do to bring down the price of health care, that would show the savings through malpractice premiums and systemic savings by more thoroughly regulating and identifying and either retraining or redeploying these individuals? Dr. McClellan. I haven't seen any specific savings estimates on that. I can tell you that as long as most of the lawsuits that are brought, most of the claims that are brought, are not related to negligent care, you know, there is only so much that you can do to focus in on providing better oversight for those really problematic physicians. I think, as part of liability reform, if we were able to take a lot of these inappropriate lawsuits off the table, then we could really concentrate our efforts on those problem physicians. Senator Reed. I do not want to be unnecessarily argumentative, but based upon observation and not analysis, most people understand in the profession, other doctors, who is competent, who is attentive. Complaints are made to medical societies. This is a mostly secret process at the local level by medical societies, and there are reasons for that, obviously. But it seems to me that you are kind of, you know, missing the point if you are suggesting we have to reform the tort system before we can focus on what may be another cause of medical malpractice, costs, and basic quality of care. Now that gets us into a whole set of issues, local licensure versus a Federal role, et cetera; but again I think, if we do not look at that, then we are not being---- Dr. McClellan. I think that is a legitimate point. I am saying that the tort system as it is now is drawing in a lot of physicians who are practicing perfectly good, if not stellar, care into lawsuits and into all of those additional pressures and costs associated with the liability. There is a foundation to build on now. There is now a national practitioner database that the Agency for Health Care Research and Quality maintains. And that is intended to be a repository of information on claims that may be brought in different States and so forth. And it can be used by hospitals, by other health care organizations, and by States in accreditation issues for doctors. Senator Reed. My final point, I think it would be extremely useful in this overall debate to try to quantify what is going on here with respect to the quality issues and the capability issues of physicians. Because if there were--I do not know, but if there were equal savings in that arena, or even greater savings vis-a-vis capping damages, certainly that is something that we would want to know about. Let me shift gears to something else under your jurisdiction, the Part D drug benefit. You are implementing it now. Many States, like my own, Rhode Island, have their own local programs. We have something called RIPAE, the Rhode Island State Pharmacy Assistance Program. There is some confusion about benefits. There is confusion about who is qualified for what. We have more robust benefits at the State level in certain circumstances, the Federal program has other benefits. Bottom-line question: What are you doing to try to address this issue, not just for Rhode Island, but particularly for Rhode Island? Dr. McClellan. Senator, we are doing a lot. And I hope, if you have been talking to any Rhode Island State officials who do not feel completely plugged into CMS right now on how to make these programs continue to work and actually improve with the implementation of the drug benefit, you will get them in touch with me and our agency right away. I just got back from a conference sponsored by the National Governors Association in Chicago, where representatives of almost every State government that have been working with us on implementing the new drug benefit, came together to take stock of where we are and what the further problems are that we need to address. We had some excellent discussions about the materials that we have already prepared for transitioning dual-eligibles, to steps that we are taking to make sure that every State saves money under the law as intended. And I feel very good about the track that we are on. In the case of programs that provided prescription drug assistance, like the Rhode Island program, the intent of the law is to build on that. So instead of the State having to pick up all of the costs on their own, the Federal Government is going to provide some comprehensive help for low-income beneficiaries. The State will have to pay virtually nothing, and more than $1,000 worth of help for higher-income beneficiaries, so the State can add to that. We have guidance and work groups that are working right now to make sure that that gets implemented smoothly. So if there are any concerns there, they need to come to us. We have got processes in place. Senator Reed. Thank you. Representative Saxton. Thank you. Sorry to have held you up, Jack. Dr. McClellan, a good doctor-patient relationship has always been considered to be a crucial element of a medical care program--caring doctors and trusting patients, I would characterize it. In a recent survey of Pennsylvania doctors, they found that 75 percent of specialists agreed with the following statement, quote, ``Because of concerns about malpractice, I view every patient as a potential malpractice lawsuit,'' end quote. Seventy-five percent of the doctors agreed with that statement. I am wondering, given that, what is the current nature of the doctor-patient relationship generally with specialists, and are you concerned about it? Dr. McClellan. I am very concerned about it. That gets back to what you brought up before, Mr. Chairman, about the fact that since most of the claims and suits that are actually brought do not involve negligent care, doctors have to view this sort of system as a lottery, as just a random risk of lots of time in court, lots of opportunities for lawyers to rake their reputations over the coals unfairly; and that clearly is going to have an impact on their relationship with patients, on how they practice. It can have an impact on how they practice medicine. It may have an impact on whether they stay in the profession. Pennsylvania is one of the States that is in red because of some documented problems in access to care, resulting from the rising pressures of medical liability. As I said at the outset, I worry that is getting worse. We are seeing big increases-- according to the Physician Insurance Association of America and other groups, big increases in the liability pressures that doctors are facing, most of it completely unrelated to negligent care. That is not a good situation when we are trying to really focus on delivering high-quality care at a low cost and focusing on fostering that doctor-patient relationship. Representative Saxton. Do you have any information relating to--obviously, the rising cost of malpractice insurance itself is an issue to doctors, and a health care cost driver. But there is another set of activities that you have referred to today as practice of defensive medicine. What percentage of the rise in health costs would you attribute--or do you have a way to do this--would you attribute to practice of the defensive medicine in conjunction with the actual cost of increases in medical malpractice? Dr. McClellan. The best estimates from our peer reviewed, published studies are that that can be 5 to 9 percent of hospital costs for serious medical conditions. Our studies looked at heart disease, which is the single most prevalent type of illness in the country. Other studies have looked at obstetrical care. They find increases as well. While the exact number may be hard to pin down, it is significant, it is much larger than the costs of the liability premiums alone. Representative Saxton. Let me turn over to the insurer side. One of the issues that occurs, which creates a problem and a medical liability crisis, is that insurers actually withdraw from the market. Obviously, insurance companies have to make a profit or they cannot stay in business. Rising claims costs may simply make this line of insurance unprofitable. Dr. McClellan. That is correct, and we have seen insurance companies pull out of this business. There are, in many States, maybe one option available, if that, for getting liability insurance. That is not a good recipe for getting liability insurance costs down. If we had a more predictable liability system, where insurers could manage and anticipate the risk more effectively, we would see lower liability insurance premiums from more competition and a healthier insurance market. But the liability insurance market is struggling in many States, and that is another aggravation, another consequence of the problems that we have with our liability system today. Insurers are there to deal with risk, But insurers like predictable risk. If you have got a lottery system where in 1 year costs can increase 40 percent for reasons that have nothing to do with things that you can easily predict, like the quality of medical practice, then it is a much tougher line of business. And we are seeing the consequences of that with insurers pulling out, and with some of the premium increases that have been mentioned. Representative Saxton. Back to the doctors. Most malpractice claims are dismissed or dropped before ever reaching trial. And among those that do reach trial, most end in a verdict for the defense. However, even if doctors are exonerated by trial, they still suffer significant costs in terms of legal fees, stress, time away from their practice, and out-of-pocket expenses. Can you discuss, if you would, the impact on doctors of being sued, even if the claims are ultimately dismissed? Dr. McClellan. There is a lot of good direct evidence on that. There have been surveys done nationally. And you can use that survey information to compare a doctor's outlook on their practice, the way that they practice in States that have implemented liability reforms to those that haven't. What you see is, in States without reforms, the doctors feel the consequences of this pressure more. They feel like they have got to do more tests, they feel more frustrated with their practice of medicine. They actually spend more time away from their patients dealing with the consequences of the lawsuits. All of these things add to health care costs, without improving the quality of medical care, and compromise the ability of doctors to deliver high-quality care to all of their patients. Representative Saxton. There are--as Mr. Reed or Mr. Hinchey pointed out, there are a lot of other factors that go into what we have seen in the spike in the cost of medical care: new kinds of treatment, inflationary pressures of various kinds, labor rates, and so on. Do you have any information that would help us understand how serious the malpractice component is in the overall costs, increasing costs of medical care? Dr. McClellan. Well, from the previous studies, again 5 to 9 percent cost differences in hospital spending that can be saved by implementing liability reforms. That adds up over time to some big savings. As I said before, if we can bring down the rate of growth in our hospital costs by 1 percentage point, that is two-thirds of the 75-year deficit for Part A, the Hospital Insurance trust fund. That is a huge impact on medical costs in this country. And some of these increases in costs are clearly worth it. Many new technologies bring new cures to patients, bring better quality of life. But as we spend more on some of these valuable new technologies to come along, to keep health care affordable, we have got to pay even more attention to getting rid of unnecessary costs in the system. That is why I think it is even more urgent; especially with the recent increases in liability costs that I documented in 2004, it is even more urgent to take action on liability reform. Representative Saxton. Thank you very much, Dr. McClellan. I don't believe that I have any further questions at this point. I would just say that we have been dealing with this subject on this committee because we think it is extremely important, and we thank you for being here today and for your input. I also suspect that the House will pass a reform measure this year. I wish I could suspect that the Senate would do the same, but we will see. So we thank you for being here today to discuss these important matters with us. And we look forward to working with you as we go forward. [Whereupon, at 11:50 a.m., the hearing was adjourned.] Submissions for the Record ======================================================================= Prepared Statement of Representative Jim Saxton, Chairman It is a pleasure to welcome Dr. Mark McClellan before the Committee this morning to address medical liability reform. Dr. McClellan brings a wealth of experience and knowledge to bear on this subject. Currently, Dr. McClellan serves as the Administrator of the Centers for Medicare and Medicaid Services, overseeing approximately one-third of health care spending in the U.S. In addition to being a board-certified physician in Internal Medicine, Dr. McClellan is also a Ph.D. economist. He has previously served as the Commissioner of the Food and Drug Administration and as a member of President Bush's Council of Economic Advisers. There is little doubt that our nation's medical liability laws need reform. Over the past few years, premiums have skyrocketed. In just the last five years, total medical liability costs jumped 47%, to a record high of nearly $27 billion. One of the central cost drivers is rising claims costs. According to the legal research firm Jury Verdict Research, the median trial award for medical liability claims stands at an incredible $1.2 million, and a recent Department of Justice study reported that nearly two-thirds of medical liability trial awards exceed $250,000. This rise in costs has reached the point where the quality and availability of health care suffer. Faced with premiums increasing 20%, 30%, or more per year, many doctors are cutting back on the scope and availability of their services. Nowhere is this trend more apparent than in obstetrics, where numerous OB/GYNs have decided it is just easier to drop the OB part altogether. Some doctors have elected early retirement or have relocated away from high litigation areas. Emergency rooms and trauma centers have also been hurt by the current crisis. The threat of lawsuits has made the practice of defensive medicine commonplace, and as a result, patients are subjected to more tests and procedures than may be warranted by clinical factors alone. Despite the rise in costs, the system is not better at compensating the negligently injured. The typical time that elapses between the date of injury and a jury verdict is close to 5 years. Moreover, it is widely recognized that only a small fraction of negligently-injured patients even file a claim. At the same time, a large majority--around 80%--of medical liability claims do not even involve negligent injuries. One study even found that more than half of all medical liability claims do not involve an injury at all. The shortcomings in the current tort system are such that even The Washington Post has noted that ``the staggering costs and irrationality of America's civil justice system are unacceptable. The tort system is something of a casino, offering windfall judgments to a small number of claimants and nothing to others--with the merits of cases seeming almost irrelevant to their valuation.'' Although each state faces its own set of challenges and problems, the medical liability crisis has nonetheless reached national proportions. Thus, we are grateful to have Dr. McClellan here to provide some insight into the problem and direction for reform. [GRAPHIC] [TIFF OMITTED] T1772.001 [GRAPHIC] [TIFF OMITTED] T1772.002 [GRAPHIC] [TIFF OMITTED] T1772.003 [GRAPHIC] [TIFF OMITTED] T1772.004 [GRAPHIC] [TIFF OMITTED] T1772.005 Prepared Statement of Senator Jack Reed, Ranking Minority Member Thank you, Chairman Saxton, for holding this hearing on an issue that has received a great deal of attention recently. l welcome Dr. McClellan and thank you for testifying today. On the campaign trail last year, President Bush repeatedly criticized trial lawyers for filing ``junk lawsuits'' that he said were responsible for rising health ease costs. The centerpiece of the Administration's medical liability reform would cap non-economic damages at $250,000 and institute a three year statute of limitations on most lawsuits. The 2004 Economic Report of the President stated that the President's reform plan would ``lower the cost of providing health care.'' However, there's little, if any, evidence to support this claim. While it is certainly troubling that medical malpractice premiums for doctors have been rising rapidly in recent years, and many physicians in my state have informed me of the cost burden and the potential impact on access to care for patients, it is far from clear that jury awards are the sole driving force as the President suggests. In 2003, the Government Accounting Office (GAO) studied states with and without caps on non-economic damages and found that the states with caps had lower premium increases than those without caps. However, GAO did not have enough data to show a direct link between malpractice award caps and premiums. Similarly, the Congressional Budget Office (CBO) has found that there are potential savings for malpractice premiums by limiting the amount of malpractice awards, but they are skeptical that a cap would provide relief for health care costs in general. Malpractice costs were $24 billion in 2002, less than two percent of total national health care spending of $1.4 trillion, according to CBO. Reducing malpractice awards by 30 percent would only lower health care costs by approximately 0.5 percent or about $7 billion. CBO also finds that limiting physicians' malpractice liability would have much impact on ``defensive medicine'' practices, such as providing unnecessary tests or procedures to avoid a lawsuit, because physicians do so more often out of concern for patients or to generate additional income than because they fear liability. Dr. McClellan, I know you have studied the issue of defensive medicine and malpractice, so I will be particularly interested in your opinions about the amount of health cost savings non-economic caps on damages would produce. I believe, however, that there are some other reasons for the latest increases in medical malpractice insurance premiums that would not be addressed by the kinds of reforms the President and his supporters are advocating. The GAO, for example, points to slower growth in insurance company investment income and reduced competition in the liability insurance market as other potential drivers behind rising malpractice premiums. We also should not lose sight of the fact that this issue must be considered in the context of medical errors and the quality of patient care, which are inextricably linked to physician accountability. A study by the Institute of Medicine reported in 2000 that between 44,000 and 98,000 people die every year because of preventable medical errors. These statistics point to a need to link any discussion of tort reform to the issues of medical errors, public safety, and, physician accountability. In the last Congress, the Republican leadership sent narrow medical liability legislation for OB/GYNs directly to the floor, thereby sidestepping serious Committee deliberation and inquiry into the nature of and possible solutions for rising insurance premiums. While it's hard to see how the President's proposal for medical liability reform will make more than a dent in spiraling health care costs; this is an important issue that lawmakers must be allowed to investigate thoroughly. I appreciate Dr. McClellan's willingness to testify on this issue, but I also hope you will be open to questions regarding your oversight of the Centers for Medicare and Medicaid Services (CMS). I have a number of questions regarding the $500 billion of Federal spending that you administer at CMS that undoubtedly has a bigger impact on physician behavior and overall health spending than medical malpractice costs. I look forward to Dr. McClellan's testimony. Prepared Statement of Mark McClellan, M.D., Ph.D., Administrator, Centers for Medicare and Medicaid Services Chairman Saxton, Senator Bennett, distinguished members of the Committee, I thank you for inviting me here this morning to discuss the important topic of medical malpractice liability reform. It is a subject to which I have devoted considerable attention, both in my capacity as a civil servant and previously as an academic researcher and an internist. As President Bush and many in the Congress and across the country have recognized, our current malpractice liability system does not serve the needs of patients and is in need of reform. It is not simply an issue of lowering insurance premiums for physicians. It is particularly about patient safety and quality of care, as well as reducing unnecessary health care spending. According to the CBO, modification to malpractice laws will result in substantial savings to the Federal Government as a result of reduced malpractice premiums. My own research shows that resulting reductions in defensive medicine may also produce savings in both the public and private health care sector of up to several billion dollars per year. All insurance programs are potentially subject to costs created by the liability environment. For example, a recent CMS letter to the Medicare Payment Advisory Commission (MedPAC) indicated that spending on physician services during 2004 rose by approximately 15 percent. A significant driver of this increase is the fact that more patients are receiving more complex and more frequent imaging services, such as magnetic resonance imaging and computer tomography scans. For several years now, in fact, spending for these diagnostic services has been rising at a more rapid rate than overall physician expenditures. Based on my own research and the research of many academic experts, my interactions with other physicians, and my experience as a clinician, it is clear to me that the practice of defensive medicine is contributing to these cost increases. The evidence suggests that reforms to the malpractice system, including caps on non-economic damages and revision of the joint and several liability rules can reduce defensive medicine, which can reduce unnecessary health care expenditures. The CBO scoring of legislation in 2003 estimated that Federal expenditures would drop by nearly $15 billion over ten years. Those savings depend only on reduced premiums. My own research concluded a reduction in defensive medicine could lower overall hospital expenditures by between five and nine percent. During FY 2004, the Medicare program spent more than $133 billion on hospital fee-for- service. That would mean potential annual savings of between $6.65 and $11.97 billion dollars, just for that program, not to mention the private sector. Even more importantly, liability reforms will improve quality and access to health care, leading to better health for Americans. I would urge the Congress to work with the Administration to formulate a plan to address the problems with our current liability system and to promote a culture of patient safety and quality within the healthcare arena. The changes in liability law have the potential not only to produce significant savings, but also to simultaneously improve patient safety and the quality of care. This morning I would like to review some of the systemic problems in medical malpractice liability and some innovative alternatives for addressing the needs of those who have been medically injured. Specifically, I would like to highlight the Department's ``Early Offers'' program as one possible way to speed resolution of malpractice claims so that patients' needs are satisfied in an effective, efficient manner. THE CURRENT SYSTEM DOES NOT WORK Malpractice liability laws seek to address two primary goals: first, to adequately compensate and care for the needs of patients who have been injured due to negligence, incompetence, or other improper conduct by a provider; and second, to motivate providers to engage in high quality, professional care. The existing system falls far short on both of these goals. The current judicial process for addressing malpractice needs to be reformed not simply to save money, but also because individuals who have just cause to make a claim are not receiving the help they need and deserve. It is well known that the vast majority of individuals injured by a caregiver do not file suit. The 1990 Harvard Medical Practice study reported that only 2 percent of individuals experiencing an adverse event due to medical negligence filed suit and, of more concern, only 1 in 14 individuals seriously injured by such an event received any sort of compensation. More recent work by some of the same researchers confirms these findings.\1\ The Physicians Insurance Association of America reports that, on average, it takes more than 5 years for an insurer to pay a malpractice claim after the date of the incident-- mostly due to delays in reporting (22 months) and delays in the tort system (43 months). When an injured patient does finally successfully settle or win a case, lawyers typically take anywhere from 30-40 percent of those funds as compensation. In short, many of those who are injured due to negligent care are simply not receiving justice because the system does not work for them. --------------------------------------------------------------------------- \1\ Studdert et al., Negligent Care and Malpractice Claiming Behavior in Utah and Colorado, Medical Care Vol. 38 No. 3 (2000), pp. 250-60. --------------------------------------------------------------------------- On the other side of the coin, the current system does not do much in terms of screening out cases with no medical merit, or in differentiating between adverse events due to negligence and unavoidable adverse events. A study published in the New England Journal of Medicine found ``no association between the occurrence of an adverse event due to negligence or an adverse event of any type and payment . . . among the malpractice claims we studied, the severity of the patient's disability, not the occurrence of an adverse event or an adverse event due to negligence, was predictive of payment to the plaintiff.\2\ --------------------------------------------------------------------------- \2\ Troyen A. Brennan, M.D., J.D., M.P.H., Colin M. Sox, B.A., and Helen R. Burstin, M.D., M.P.H., ``Relation between Negligent Adverse Events and the Outcomes of Medical Malpractice Litigation,'' The New England Journal of Medicine, Volume 335: 1963-1967, December 26, 1996, Number 26. --------------------------------------------------------------------------- The same study reported that 10 of 24 cases involving no adverse event whatsoever were settled with a mean payment of nearly $29,000. Six of 13 cases involving an adverse event not due to negligence were settled with a mean payment of more than $98,000. More broadly, of claims filed during 2003, only about a third resulted in some payment to the plaintiff, and of the small percentage that go to trial, more than three in four resulted in a finding for the defendant, immediately leading one to question the validity of the bulk of claims.\3\ --------------------------------------------------------------------------- \3\ Physician Insurers Association of America, ``PIAA Claim Trend Analysis'' 2003 ed. (2004). --------------------------------------------------------------------------- Rapidly rising premium rates can have a real impact on patient access to care. A study by the Agency for Healthcare Research and Quality examined how the supply of physicians varied across states between 1970 and the present. The study concluded that states adopting caps on non-economic damages experienced about 12 percent more growth in physicians per capita than States without caps. Notably, the study also found that States with relatively high caps were less likely to experience an increase in physician supply than States with lower caps.\4\ This sort of disparity can translate into very real access challenges. It means that it is more difficult for patients to find the types of specialists they need, that they must go further out of their way, and take more time from their own lives to access the care they require. In some cases, the limitations on access result in negative health outcomes as well. --------------------------------------------------------------------------- \4\ Hellinger, Fred J., Ph.D., and William E. Encinosa, Ph.D., ``Impact of State Laws Limiting Malpractice Awards on Geographic Distribution of Physicians,'' Agency for Healthcare Research and Quality, July 3, 2003. --------------------------------------------------------------------------- Just to illustrate, a 2004 survey of Ob/Gyns in Illinois found that in the previous two years, 11 percent had stopped practicing obstetrics as a result of medical liability concerns. Based on how many office visits physicians report in an average month (N=250), that means 46,250 office visits for Ob/Gyn services were lost across the state during those two years. The malpractice system has important adverse effects on quality as well. In a widely read 1999 report, ``To Err is Human,'' the Institute of Medicine (IOM) noted that: [R]eporting systems are an important part of improving patient safety and should be encouraged. These voluntary reporting systems [should] periodically assess whether additional efforts are needed to address gaps in information to improve patient safety and to encourage health care organizations to participate in. . .reporting, and track the development of new reporting systems as they form.\5\ --------------------------------------------------------------------------- \5\ Committee for Quality Health Care in America/Institute of Medicine, ``To Err is Human: Building a Safer Health System,'' 2000. --------------------------------------------------------------------------- The IOM emphasized that fear of lawsuits deters doctors and hospitals from making reports, even when they are not negligent, because in many states such reports can be used against them in court. This very understandable concern impedes quality improvement efforts. If our liability laws do not encourage error reporting and analysis, they serve only to perpetuate the very problems that they ostensibly exist to address. The truth is that common human decency and professional ethics are sufficient motive for the vast majority of physicians to provide the best care possible. Most medical errors today are not the result of bad doctors or nurses, but rather the result of complex or difficult systems in which they work. You would think that we would do everything in our power to encourage the kind of self-analysis and systems evaluation necessary to identifying and addressing systemic errors. Instead, our current tort system sets up roadblocks that discourage this very important activity. This roadblock needs to be removed. Congress should pass patient safety legislation that includes a mechanism for allowing anonymous reporting of errors and that protects databases of such information from discovery. If we don't collect this data, we'll never see the patterns that will allow us to make changes to improve patient safety and will never realize the concurrent savings resulting from reduced errors. THE COSTS OF OUR CURRENT SYSTEM As an acadmic, I conducted my own research on this subject that focused on whether, and to what extent, physicians engage in defensive medicine as a result of their concerns over being sued. In 1996, Stanford University Professor Daniel Kessler and I conducted a study on the extent to which physicians engage in defensive medicine.\6\ We examined national data on Medicare beneficiaries experiencing a new primary diagnosis of serious cardiac illness in 1984, 1987, and 1990. We also compiled a comprehensive database of reforms to state liability laws and malpractice control policies from 1969 to 1992. Each of the observations in the Medicare data set was matched with a set of two tort law variables that indicated the presence or absence of direct or indirect malpractice reforms at the time of their initial hospitalization. Dr. Kessler and I found that direct liability reforms, such as caps on damage awards; abolition of punitive damages; and mandatory prejudgment interest and collateral-source rule reforms reduce hospital expenditures by 5 to 9 percent within 3 to 5 years of adoption. The drop in expenditures resulted from a change in physician practice patterns that we attributed to a moderation in defensive medicine. It is important to note that this shift had no consequence in terms of patient mortality or other serious adverse health events--that is, reforms made it possible to lower medical costs significantly without compromising quality of care. This particular study was peer reviewed and published in The Quarterly Journal of Economics. In 1997, the International Health Economics Association, a well-known global professional association of health economists, presented us with the Kenneth J. Arrow Award for this article. --------------------------------------------------------------------------- \6\ Kessler, Daniel P. and Mark B. McClellan, ``Do Doctors Practice Defensive Medicine?'' The Quarterly Journal of Economics, vol. 111, no. 2, May 1996. --------------------------------------------------------------------------- The article's findings on the impacts of liability reforms on cost and quality are supported by a substantial body of other work. In an earlier study published in the Journal of the American Medical Association, researchers found a positive relationship between malpractice claims risk and rates of cesarean sections.\7\ In a 2002 paper also published in a peer-reviewed economics journal, Dr. Kessler and I further explored the role of malpractice reforms in reducing defensive practices. Dr. Kessler and I found that malpractice reforms affect physician behavior by changing both financial measures of ``malpractice pressure'' (such as malpractice claims rates and malpractice insurance premiums) and non-financial measures (such as the time and hassle spent in defending against a claim). \8\ --------------------------------------------------------------------------- \7\ Localio, Russell et al., Relationship Between Malpractice Claims in Cesarean Delivery, JAMA Vol. 269, January 20, 1993, p. 366. \8\ Kessler, Daniel P. and Mark B. McClellan, ``How Liability Law Affects Medical Productivity,'' Journal of Health Economics, vol 21 (2002) pp. 931-55. --------------------------------------------------------------------------- Based on the work we did, Dr. Kessler and I concluded that if direct liability reforms had been adopted nationwide between 1984 and 1990, it would have resulted in annual savings of $450 million for each of the first two years and close to $600 million for each of the succeeding years for just the two conditions we studied.\9\ As I mentioned earlier, our study concluded that these reforms could potentially reduce overall hospital expenditures by five to nine percent. Those kinds of savings, if realized, could have a significant impact on the fiscal health of the Medicare and Medicaid programs. Furthermore, as stated above, these savings would come without any drop in the quality of care and outcomes experienced by patients. --------------------------------------------------------------------------- \9\ Kessler, Daniel P. and Mark B. McClellan, ``Do Doctors Practice Defensive Medicine?'' The Quarterly Journal of Economics, vol. 111, no. 2, May 1996. --------------------------------------------------------------------------- CBO has taken issue with the estimates from the paper written by Dr. Kessler and me, contending that tort reform will not reduce defensive medicine. CBO used our work as a model, but their efforts are hampered by two critical methodological limitations. First, when CBO sought to replicate our study on a more recent sample of patients with the conditions we examined, it obtained similar results to ours. The finding of insignificant effects arose only when CBO sought to re- estimate our models on a set of patients with very broadly defined illnesses. Because hospital expenditures on patients with a broad range of illness are likely to be heterogeneous and hard to predict, the unexplained variance in hospital expenditures for these patients is likely to be large--larger than the unexplained variance in hospital expenditures for patients with clearly defined illnesses we studied. Since the standard errors of the estimates of the effects of limits on liability are proportional to the unexplained variance in expenditures, the statistical significance of estimates from models with broadly defined illnesses would be less than the significance of estimates from models with narrowly defined illnesses. Second, we used more comprehensive data, while CBO used data from a 20 percent random sample of beneficiaries for most (1991-1996) of their study period. Third, there was very little variation in states' tort laws during the CBO's entire study period (1991-1999)--according to CBO staff, only 6 states changed one or the other of the two liability system variables under analysis. In the period that we studied (1984- 1994), 33 states changed one or the other of the liability system variables under analysis. These two differences--the less comprehensive data and the smaller number of ``experiments'' in the CBO analysis-- would also lead the statistical significance of estimates reported in their brief to be lower than the significance of our estimates. It is important to put the differences between myself and Dr. Kessler, and the CBO, in the context of what we focused on. CBO has not made estimates of savings from reductions in defensive medicine. They have, however, concluded that reduced premiums would save the Federal Government billions of dollars. My own research shows the potential for billions more in savings as a result of reduce defensive medicine. What we both end up saying--along with numerous other researchers--is that reforms will lead to billions of dollars in savings each year. LIABILITY CONCERNS REDUCE PHYSICIAN PRODUCTIVITY Every time our malpractice system ties up a physician in judicial or administrative matters, then their clinical skills are temporarily removed from the productive pool. Even small drops in the average amount of time spent on malpractice claims will have the beneficial result of making physicians more productive in terms of patient care, which is ultimately where we want them to spend their time. The 2002 paper with Dr. Kessler that I mentioned, documented how this works: reform-induced decreases in the time and hassle spent defending against malpractice claims leads to lower health care costs, but not worse health outcomes. The perceptions of practitioners themselves back up these statistical results. A 2002 poll by Harris Interactive found that the fear of litigation impacts healthcare administrative issues. Well over three-fourths of all physicians and nurses (84% and 81%, respectively) reported that they spend more time on paper work, such as medical record documentation, because of malpractice concerns than they would based solely on the patient's clinical needs. Additionally, nearly all physicians (94%) believe that written descriptions of cases are very often or sometimes influenced by the fear of litigation.\10\ --------------------------------------------------------------------------- \10\ Taylor, Humphrey, et. al., ``Common Good Fear of Litigation Study: The Impact on Medicine,'' Harris Interactive, April 11, 2002. --------------------------------------------------------------------------- In a 1997 paper, Dr. Kessler and I investigated how the intrusiveness of the liability system affected physician perceptions of medical care. We estimated the impact of liability reforms on objective measures of malpractice pressure--such as claims rates--and on perceptions of the effects of malpractice pressure on practice patterns. The study found that malpractice pressure affects physician perceptions of two important dimensions of medical practice: propensity to make referrals, and the ability to spend time with patients.\11\ --------------------------------------------------------------------------- \11\ Kessler, Daniel and Mark McClellan, The Effects of Malpractice Pressure and Liability Reforms on Physicians Perceptions of Medical Care, Law and Contemporary Problems Vol. 60 (1997) pp. 81-106. --------------------------------------------------------------------------- More generally, the legalistic atmosphere in which physicians practice warps the physician-patient relationship. Hauser et al. give a good example of how fear of litigation can reduce the trust in the physician-patient relationship and actually become a barrier to clear and effective communication. A woman went to a gynecologist for a problem and a minor surgical procedure was recommended. At the beginning of the discussion of this procedure, the physician commented, ``The law requires me to inform you of certain facts about this operation.'' And then, in a perceptible alteration of his normal patterns of speech, the gynecologist began to chant a litany of side effects, risks, morbidity, mortality, percentages, probabilities, etc. The patient later reported that after about ten seconds of listening to this, her mind shut down entirely. ``This appears to be some sort of arcane ritual! The communication was not directed to me for any benefit of mine whatsoever.\12\ --------------------------------------------------------------------------- \12\ Hauser MJ, Commons ML, Bursztajn HJ, Gutheil TG. ``Fear of Malpractice Liability and its Role in Clinical Decision Making,'' in Gutheil TG, Bursztajn HJ, Brodsky A, Alexander, v. Decision Making in Psychiatry and the Law. Baltimore: Williams & Wilkins, 1991. --------------------------------------------------------------------------- High-quality medicine requires effective communication with patients. The various tests and procedures available to us provide a tremendous amount of useful information, but often, a diagnosis, or the type of test to utilize, is prompted by something the patient shares with the physician in conversation. If, because of liability concerns, physicians are unable to discuss the inherent ambiguities and complexities of medical practice, and the variety of potential outcomes to a given procedure or service, in a manner to which the patient can personally relate, then the patient's ability to make informed decisions is compromised. Our current system, because it recasts this relationship in legalistic terms does not promote mutually beneficial exchanges of information. INNOVATIVE PRIVATE SECTOR APPROACHES Although those in the private sector cannot modify tort law, a number of organizations and providers have begun experimenting with mediation, with some success. Some time ago, Johns Hopkins Hospital began requiring non-emergency patients who came to them for elective procedures (individuals who had the option of going elsewhere if they so chose) to sign an agreement to take any malpractice claims to mediation prior to going to court. In 2003, Hopkins mediated 24 cases and resolved 21 of them. As a result, Hopkins 2003 claims expenses decreased almost 30 percent. Mediation is typically much faster than a court case and involves far lower attorney's fees. In short, patients who are injured get compensated at a higher level and in a shorter amount of time. Furthermore, this reform has helped the hospital communicate more freely with the patients, and probably with the professional staff, in order to be sure the mediation is successful and the highest possible quality of care is achieved. TORT REFORM AND LIABILITY INSURANCE PREMIUMS As you are well aware, a fairly fierce debate over how the medical malpractice system should be reformed has been going on for some time now. While more research evidence would help in making the path forward obvious to all, there is no question that liability reform has the potential to produce significant healthcare savings, as well as reduce problems of access and quality care. The time to act on this issue is now--from the standpoint of health care quality and cost, we can't afford to wait. A number of possibilities exist for improving our medical liability system. Tort reforms include actions such as capping awards for pain and suffering, so called non-economic damages, as well as capping punitive damages. In addition, suggestions have been made to reframe rules for joint and several liability, such that each actor involved in a given episode of care, including the physician, hospital, and payer, all bear a level of blame proportional to their share of fault or responsibility. Liability for damages would not be joint. As another option, attorneys' fees could also be capped, so that more of the dollars won by a plaintiff with a meritorious case actually go to that individual to address their health needs, and large awards could be paid as an annuity, or over a number of years, instead of as a lump sum, so that the money is available in the future when the individual needs it to pay for care. Collateral source rules, taking into account funds coming from health, automotive, or workers' compensation insurers, could also be modified to allow reductions in settlements or jury awards commensurate with insurers' payments. Alternatively, mandatory pre-trial screening by an independent medical expert to weed out baseless claims could reduce the number of baseless suits faced by physicians. President Bush supports securing the ability of injured patients to get fast, unlimited compensation for their economic losses, including the loss of ability to provide unpaid services like care for children or parents, but has urged the Congress to support a cap of $250,000 on non-economic damages, limit punitive damages, eliminate joint and severable liability, create a uniform statute of limitations, and provide for the structured payment of future damages. According to the GAO, the greatest driver of increases in physician liability premium rates is losses suffered as a result of malpractice claims.\13\ They also concluded that states with tort reforms that include certain damage caps had lower growth in liability premiums than did those without such caps. Another study by Stephen Zuckerman et al. concluded that capping medical liability awards reduced premiums for general surgeons by 13 percent in the year following enactment of that reform and by 34 percent over the long term. The reforms resulted in similarly lower premiums for general practitioners and Ob/Gyns.\14\ A 2002 HHS study found that during 2001, states with meaningful caps on non-economic damages saw average premium increases of 15 percent, while states without such caps saw increases of 44 percent.\15\ --------------------------------------------------------------------------- \13\ Hillman, p. 1. \14\ Stephen Zuckerman, Randall R. Bovbjerg & Frank Sloan, ``Effects of Tort Reforms and Other Factors on Medical Malpractice Insurance Premiums,'' 27 INQUIRY 167-182 (19.90). \15\ ``Confronting the New Health Care Crisis: Improving Health Care Quality and Lowering Costs by Fixing our Medical Liability System,'' HHS Office of Assistant Secretary for Planning and Evaluation, July 24, 2002. --------------------------------------------------------------------------- Like many academic studies, my own research has demonstrated that direct tort reform, including capping damages, abolition of mandatory prejudgment interest, and collateral source rule reforms reduce premium expenditures significantly. The 1997 paper with Dr. Kessler I mentioned above showed that in states adopting such reforms, within three years physicians saw substantially and statistically significant lower trend growth in their real malpractice insurance premiums of approximately 8.4 percent.\16\ --------------------------------------------------------------------------- \16\ Kessler, Daniel P. and Mark B. McClellan, ``The Effects of Malpractice Pressure and Liability Reforms on Physicians' Perceptions of Medical Care.'' --------------------------------------------------------------------------- Amounts paid on malpractice claims, either in settlement or because of a jury award, have been growing substantially in the past few years. The Physician Insurers Association of America (PIAA) reports that the median jury award in medical liability cases nearly doubled from 1997 to 2003, increasing from $157,000 to $300,000. The PIAA's as yet unpublished report on 2004 indicates that the median jury award during that year was $439,400; a one-year increase of more than 46 percent. It is notable that PIAA found a 2004 mean payment on a jury verdict of $606,907. Such a large difference between the median and the mean indicates the existence of a significant number of large awards. The size of settlements has similarly increased. Median settlements increased from $100,000 to $200,000 between 1997 and 2003. As previously noted, these increasing losses drive increases in premiums. However, physicians must also pay legal fees. Physicians who win at trial have average defense costs of $87,720 per claim and in cases where the claim was dropped or dismissed, their costs averaged $17,408.\17\ --------------------------------------------------------------------------- \17\ ``Physician Insurers Association of America, ``PIAA Claim Trend Analysis: 2003 ed. (2004). --------------------------------------------------------------------------- There is substantial evidence on the positive effects of tort reform to provide a basis for congressional action at this time. Not only will tort reform result in lower premiums, but, much more importantly, it will help foster an environment in which physicians do not feel the need to engage in defensive medicine and we will see our costs drop as a result. Tort reform will increase access to healthcare and it will result in improved quality as providers feel the freedom to openly discuss systemic improvements that will lead to a higher degree of patient safety. I would urge the Congress to take this issue up and act on it. THE IMPACT OF MARKET FORCES There is no significant controversy about whether the number of claims made against physicians and ballooning settlements and judgments has contributed to rising premiums. However, there are others who contend that the tort system itself is not the only reason for premiums to increase; they argue that the insurance market also contributes to the rise in premium rates. Insurers typically invest the bulk of their revenues into bonds. Some people argue that during the stock market rise of the 1990s, insurers realized profits from their investments that allowed them to reduce premium rates. They contend that as the stock market has suffered declines, insurers have raised their premiums to make up for investment losses. In addition, many insurers purchase reinsurance from larger entities. Some say that such reinsurance has become increasingly expensive in the past few years, particularly after the tragedy on September 11, 2001, and that it is also common for insurers entering a new market to provide lower introductory rates in order to obtain market share, and then raise the rates once they have an established client base. In addition to business cycle factors, the St. Paul Company, one of the larger physician insurers in the country, decided to cease providing malpractice coverage at the end of 2002. This action reduced competition among insurers and allowed them to, at least temporarily, increase their premium rates. Critics of tort reform efforts point to all of these factors as relevant to the malpractice debate. They argue that we should not engage in tort reform if it is not the only driver increasing premiums and expenditures. The GAO concluded that although none of the companies it examined experienced a loss on their investments, a 1.6 percent decline in investment return from 2000 to 2002 would have resulted in premium increases of 7.2 percent over the same period.\18\ Such a decline would not have been outside the realm of possibility given market movement during that period. Studies like these lend credence to the argument that a component of liability premium increases may result from factors other than rising settlements and jury awards. --------------------------------------------------------------------------- \18\ Hillman, p. 8. --------------------------------------------------------------------------- That said, the present problem in many States is not the result of the so-called ``insurance cycle,'' or reckless investments by insurance companies. Although we have been on an ``up'' part of the cycle, that does not explain extremely high premium increases in the last few years in some States that have not reformed their liability system, compared to much smaller increases in most of the States that have implemented significant reforms. The insurance cycle is not a phenomenon that occurs in some States but not others. But the growth in liability premiums and even the availability of liability insurance has clearly varied substantially across states, in association with differences in liability laws. Consequently, reforms in insurance would not address the underlying causes of the problems of unnecessary costs, lower quality, and less access to care that result from our current liability system. Insurance market reforms will not change physicians' perception of the liability environment in which they work and market reforms will not reduce the level of defensive medicine. Furthermore, market based reforms will not produce swifter settlement of claims, or improve the equity of injured patients' compensation. ADDITIONAL STEPS TO IMPROVE OUR LIABILITY SYSTEM In late September of last year, then-Secretary Thompson announced an HHS initiative to deal with claims made against providers who are employees of the Department, including those practicing at community health centers or through Indian Health Service programs. To reduce the amount of time it takes a patient to receive compensation, HHS designed the Early Offers program to encourage rapid settlement of cases, provide quick payment in deserving cases, and avoid the delay, cost, and emotional distress of litigation. When a patient who has been served at a federally-funded health center or Indian Health Center facility files a medical malpractice liability claim against HHS, we send a standard notice explaining our early offers program. Both sides have 90 days to submit a confidential offer to a neutral third party who will compare the offers and notify both sides only if a match is made. Not only are offers voluntary, their amount and existence remain confidential forever if no match is made. So neither side tips its hand or loses leverage if the case goes to court. The program is up and running at HHS and we're hopeful that it will show promising results in the months to come. In the meantime, any doctor or hospital can set up an early offers program. Because an early settlement only occurs when both parties agree, you're not losing any options by setting up a program, and no government action is required. Evidence on how we can improve quality of care for patients should drive our reform efforts. We should be sure that if doctors take steps to encourage quality, for example, installing and using electronic medical records so that they can more easily track adverse events and thereby prevent them, that these physicians are not then punished by our legal system. If a physician who is considering such a system has in the back of his/her mind the fact that some day an attorney might use his data to bring suit, that physician may abandon the idea altogether. We should be looking to create systems that support quality care, that provide the data that are needed for good decision making. To illustrate what can happen when physicians are able to be more open with their patients about medical errors, I would point you to the experience of the Lexington, Kentucky Veterans Affairs medical center. In 1987, after losing two malpractice cases with judgment totaling more than $1.5 million, this facility adopted a policy of radical honesty. They began to openly and immediately discuss with patients and/or their families any errors that occurred during treatment, including giving the patient information about their right to file a claim or an application for compensation. Furthermore, the facility disclosed medical errors when the patient or family had no reason to know one had occurred. A 1999 study of the Lexington facility's claims experience during the years 1990 to 1996 concluded that the facility did not pay any more in malpractice claims than comparable VA facilities, and had concurrently avoided significant legal expenditures.\19\ Partially due to the success of the Lexington policy, the VA adopted this practice system-wide in 1995. --------------------------------------------------------------------------- \19\ Kraman, Steve S. and Ginny Hamm, ``Risk Management: Extreme Honesty May be the Best Policy,'' in Annals of Internal Medicine, vol. 131, issue 12, 21 December 1999, pp. 963-67. --------------------------------------------------------------------------- The VA is not entirely analogous to the private market, but I bring up this example because it demonstrates how the real needs of patients who have been injured can be addressed more adequately when systems are in place to encourage patient-physician communication. CONCLUSION We are considering a variety of administrative ways to test innovative ideas that would lead to a solution to the malpractice problem. Mr. Chairman, the current medical liability system simply does not address the needs of patients, and it's costing those patients, the Federal Government, and other payers billions of dollars every year because it adds to costs and encourages care that does not improve health. More importantly, our liability system reduces access and reduces quality of care. I would encourage the Congress to take action on this issue and would be happy to work with you as you move forward. I would be pleased to take any questions at this time. 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