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Copyright 1999 Federal News Service, Inc.  
Federal News Service



LENGTH: 20000 words

9:30 AM.

SEN. JAMES JEFFORDS (R-VT): The Senate Health Committee will come to order. Today's hearing on medical necessity from the theory to practice will provide committee members with an opportunity to hear testimony about the issue of medical necessity. An issue that lies in the heart of the debate on health care quality and consumer protection. In this hearing we will explore issues surrounding determinations of medical necessity and practice, in plan contracts and policy, and in proposed legislation. In particularly we will be faced with a question of whether congress should enact a statutory definition of medical necessity and there by legislate a standard for medical decision making. And that is the purpose of the hearing this morning.
At this hearing we will explore some difficult questions. Should a treating physician's decision ever be challenged? Do health care plans place to much emphasis on cost criteria when making decisions? What is the best way to insure that patients, physicians, and plans make decisions based on the most up to date research and evidence? What evidence is available to guide decision making? When and how should the evidence be applied to decisions about medical care? The committee will need to focus on how the answers to these questions impact the quality of care that patients receive.
Fortunately, we have before us today an outstanding panel consisting of national experts, most of whom are physicians, who will help us explore these complex and sometimes emotional questions. These experts will describe the state medical decision making as it exists today and make suggestions on how it can be improved. They will also talk about the use of medical necessity criteria and how it is used or not used in plan contract, in the claims and appeals process and at the bedside. In addition they will suggest for us the most appropriate role for the government in the matters of medical necessity decisions.
On our first panel, what I'm going to do is ask all of the witnesses to testify before we have questions. We have a vote a 10:30. That way we will make sure that we get to hear, everyone that can attend here will get to hear all the evidence. And then we will have questions following that.
So our first panel we will hear from Dr. Jack Wennberg from Dartmouth Medical School, who is renown for his research on clinical practice variations. If the doctor will come forward. Mr. Wennberg will testify about variation in clinical decision making and the impact of this variation on the quality of care that patients receive. Dr. Wennberg will examine in his testimony the principles evidence based medical practice and generally accepted medical practices to help us understand how these concepts may impact patients.
Our second panel we have 3 of the nation's leading experts on the issue of medical necessity. These experts will explore their findings on the use of medical necessity criteria and definitions in private contract. They will describe how definitions of medical necessity and proposed legislation would impact the quality of care and to the extent which would generally excepted medical practices may affect the emergence of best practices. And they will also tell us what role Congress should play in ensuring that the best possible medical decisions are made for patients.
In our third panel we will hear the prospective of health plans, business purchases of health care, and practicing physicians.
These representatives will discuss how medical decisions should be made, and who is the best person or persons to make these decisions. They will discuss how individual physician opinion, medical science in evidence, and generally accepted practices impact on the quality of care. They will also comment on the proposed legislation and tell us how it may impact health care costs, plan designs and contracts, and the benefits offered by employees.
So with that I'll ask Senator Kennedy.
SEN. EDWARD M. KENNEDY, (D-MA): Thank you very much, Mr. Chairman.
I want to commend our Chairman, Senator Jeffords, for holding today's hearing on the improving of the quality of health care and protecting the rights of patients in HMO's, and other health plans. The legislation to end the abuses by these plans failed in the last Congress, but its needed more than ever today. And I'm optimistic that it will be enacted as one of the highest priorities this year.
Too many HMO's and insurance plans are denying patients the care they deserve, too many medical decisions are being made by insurance company executives, and not doctors. Too many patients are suffering because managed care plans are putting profits ahead of health.
Our patients Bill of Rights will grant needed protections to all patients with private health insurance and one of its most important provisions is its definition of medical necessity, the subject of the hearing today. If a service is covered by a health plan, a patient is entitled to receive it, if it is deemed necessary by a medical professional. Not by an insurance company executive, not by an lawyer, not by an employer, not by a physician or other qualified, but by a physician or other qualified medical expert.
Without this protection, all the other safeguards, of the patients Bill of Rights are worthless, because HMO's can rewrite their contracts to continue to give them the final say on medical decisions, even if there's independent third party review. That is why the insurance industry opposes this provision so vehemently.
Without a definition of medical necessity, any bill to protect patients is a sham. A reckless misinformation campaign is being waged by HMO's against this provision. The claim made by those who profit from the status quo is that our provision would allow any physicians to order any care they choose, whether or not the care is appropriate for the patient. Our proposal does nothing of the kind.
Our legislation uses a professional standard based on case law and standards historically used by insurance companies. Our definition of medical necessity is reasonable for both the plan and the patient. It is based on evidence in the particular case in general clinical standards. Definitions like these have evolved, based on medical practice of the past 200 years. The Hippocratic oath taken by physicians says, do no harm to patients. What is it that plans fear about codifying a principle that has served us so well for 200 years?
We cannot stand by and see that ancient ethical principle of medicine transferred into a practice that says, do no harm to profits. The easiest way for an HMO to protect profits is to deny care, even when the care is covered under the policy and recommended by the doctor. Too often, HMO's and other insurance companies deny services that ought to be covered by saying that the services are not medically necessary. But who decides whether particular services are medically necessary or appropriate for a patient. Unfortunately in too many cases it's not the doctors and the best medical experts, but the HMO.
The specific provisions in the patients Bill of Rights that has generated today's conversation are found in Section 151. Two elements are critical. We prohibit plans from arbitrarily interfering with the decisions on the matter or setting in which care is delivered, if that care is medically necessary or appropriate.
We then define medical necessity as care consistent with generally accepted standards of professional medical practice. These provisions have the support of the American Medical Association, and nearly 200 additional leading organization that represent doctors, nurses, patients, and working families and others.
Our legislation does not mean anything goes. Clearly there are limits on care and the doctor's recommendation can be challenged. Generally accepted principles include the best medical evidence, and the opinions of the best qualified doctors. The fundamental point is that not all patients fit neatly into the boxes developed by business consultants and administrated by accountants. Objective standards should determine what is medically necessary care. Without such a standard, a patient's Bill of Rights is nothing more than a patient's bill of goods.
External review is meaningless unless the independent reviewers have the ability to objectively determine whether the care and dispute is medically necessary. The bottom line is that individual medical decisions should be made primarily by doctors, and patients. If health plan executives are making medical decisions they should have to justify those decisions in the same way that a physician does and they should be accountable for those decisions.

The issue of how particular services are determined to be medically necessary is fundamental to enactment of a genuine patient protection legislation. Patients deserve the piece of mind that comes with knowing that their medical needs come first, when a dispute arises between the insurance company and their doctor.
I look forward to working with my colleagues on the committee and the Senate to pass legislation to grab these needed protections and assure all American families that the health insurance they pay for will be there when they need it.
I thank the Chairman. SEN. JEFFORDS: Our first witness this morning is Dr. John E. Wennberg, who is the District Director of the center for Evaluative Clinical Sciences at Dartmouth Medical School, Hanover, New Hampshire.
Since 1980, he's been a professor in the Department of Community and Family Medicine, and since 1989 in the Department of Medicine. In addition to an M.D. from Magill Medical School, Dr. Wennberg holds a Masters in Public Health from the John Hopkins University.
Among other professional achievements, Dr. Wennberg, participated in the development of a strategy for studying the population based rates of health resource allocation and utilization revealing large variations in the rates among local and regional health care markets apparently often related to the distribution of resources and to differences in local medical opinion. I also understand you got your start in my hometown at the (Rothman ?) Hospital, so it's special greeting from me and a pleasure to have you here and please proceed.
DR. WENNBERG: Thank you, sir. Thank you for the opportunity to testify. I have 3 concerns with the proposed definition of medical necessity in S 6. My first is that medical science plays only a limited role in establishing the principles of professional practice. Far more often than we would like medicine is not evidence based, that is to say that it is not based on demonstrative relationship between health care inputs and health care outcome.
There simply is no national consistency about the best way to practice medicine based on knowledge of the outcomes of the care or the preference of the patients. My second concern is that when medical science is weak, when the best course of action is uncertain or simply unknown medical necessity is a matter or provider opinion. Medical necessity in one community is unnecessary care in another. The varying local definitions in medical necessity are dramatically seen in the various ways end of life care is provided.
In our studies we been looking at end of life care across the United States. In Miami many care enrollees visits physicians an average of 48 times per person in the last six months of life. In Rochester Minnesota, home of the Mayo Clinic the average is only 14 visits. In Sun City California, 48 percent of Medicare enrollees are admitted to an ICU at least once in the last six months of life. In Sun City Arizona, a second retirement community, the proportion is less than 14 percent. In other words, about three and four fold differences. In Manhattan many care enrollees spend an average of 22 days in hospital during the last six months of their lives. And in Portland Oregon the average is four point five days.
In debating medical necessity it is important for the committee to keep in mind that generally accepted principles of professional practice have at best, a weak constraining influence on the health care economy on a price and illness adjusted basis. In 1996 Medicare spending in Miami was two point one times greater than in Minneapolis.
My third, concern is that the proposed S 6 definition does not included the patient as a partner in determining medical necessity. What is medically desirable care for one patient is unnecessary or unwanted care for another. The choice of treatment for breast cancer is a cogent example. Most women who are diagnosed with breast cancer have a choice between two treatments, breast sparing surgery or total mastectomy. Both treatments are equally affective in reducing mortality, based on good scientific evidence.
But the other outcomes in the treatment are very different. A woman who has a lumpectomy avoids the loss of her breast, but faces radiation treatment and a threat that her cancer may recur locally. A woman who chooses mastectomy avoids radiation and local recurrence, but forfeits her breast. These are very personal choices and they clearly belong to the patient. But in the real world, who is now deciding? Physicians have a strong and substantially different opinion about the appropriate way to treat breast cancer.
In 1992 and '93 in some parts of the country fewer than 2 percent of Medicare women had breast sparing surgery, in other parts of the country the proportion of women having breast sparing surgery approached 50 percent. Who should decide? When individual patient preferences differ, the patient must decide. Typically, shared decision making is the right course of action. As I indicated in my written testimony, economic concerns point in the same direction.
Senator Jeffords, you ask that I offer my recommendations about appropriate government role in approving clinical decision making, I have 3 suggestions. First, expand the definition of medical necessity to include a focus on patients. The debate over the rights of patients to choice in health care is focused almost exclusively on the choice of health plan. If we are serious about patient's rights, then we must pay attention to the importance of patient participation, and the choice among valid treatment. If the committee agrees to include a definition of medical necessity in S 6, I hope it will expand its definition to include the patients. And I've offered some language in my written testimony.
Second, seek to assure that Medicare and Medicaid patients have access to understandable evidence based information concerning their treatment options. In order to participate, patients must have full information about the risks and benefits of their options. The principle payer for Medicare and Medicaid programs, the Federal Government has a special obligation to assure that its beneficiaries are well informed about treatment options.
My third suggestion is that this committee should take a special role in promoting evaluation of untested medical theory and the growth of evidence based medicine. The argument goes as follows. A sound efficient health care economy depends on information. It is a scientific disgrace and a disaster for the health care economy that the research establishment has failed to implement research programs that could assure the systematic and continuous evaluation of common practices of medicine.
Establishing the scientific basis for medical necessity is an enormous and long-term project, which desperately needs the on going attention and understanding of Congress. This committee is well situated to take responsibility. I urge you to take the problem of assuring the orderly development of evidence based medicine high on your agenda.
SEN. JEFFORDS: Thank you Dr. Welcome Senator Frist and Senator Collins. What we're going to do is listen to all the witnesses first, you can stay right there Dr. Wennberg, I'm sorry, I'm going to bring the next panel up and then we'll have a ball, and when we come back we'll ask questions.
I'm happy to introduce our second panel consisting of professionals in health policy and quality research. Professor Sara Rosenbaum is the Herald and Jane Hersch Professor of Health and Law and Policy at George Washington University Medical School, School of Public Health and Health Services here in Washington DC. Professor Rosenbaum also directs the Center for Health Policy Research. She served as a consultant at the White House Democratic -- Domestic, Policy Council and directed the drafting of the Health Security Act for President Clinton. Professor Rosenbaum we've looked forward to your testimony and please proceed.
MS. SARA ROSENBAUM: Thank you, Senator. For purposes of today's hearing, no issue is more important than the structural framework of managed care, which merges healthcare and healthcare quality. The two concepts become completely inseparable in managed care. And for this reason, the quality improvement legislation that you are going to consider this session, has at its heart the question of what the quality of the treatment decision making process will look like. In order to have a treatment decision making process that is of proper quality for Americans, that process has to include as part of the external review and appeals process the same objective professional standard of care that has for more than two centuries governed healthcare, both here and abroad.
The professional standard concept is a legal concept that has its roots in the English Common Law. It was developed by courts in order to articulate a standard of care for measuring the quality of care furnished by physicians it's the proper standard of care for medical practice because we need a standard that is different from the reasonable person. Most of us reasonable people cannot, without professional aid, measure the quality of care. The professional standard is the way of thinking about providers' conduct toward individual patients in light of the current state of knowledge of medical care within the profession. It should be noted as well, and on this point, I disagree with Dr. Wennberg the professional standard is not satisfied without informed consent. That is integral with the professional standard. The professional standard turns not on what a single doctor thinks he or she would like to do, but on the best evidence of what is quality medical practice.
An objective professional standard is, therefore, the best means for measuring quality. In a situation where an insurer is measuring whether or not care will be furnished to an individual patient, the kinds of general quality improvement activities that we've come to expect from the insurance industry and from health professionals generally take a back seat to a very different kind of process. A process where an individual patient's case is in front of an individual group of decision makers and a decision needs to be made in that individual's case regarding what's processed. Most of the time, those decisions will be the normative decisions, if it weren't true there wouldn't be treatment norms that's the way norms work. But there are patients, they are few and far between, and that's probably why we see so few external appeals actually, who need added consideration because their cases don't fall within the norms. They have comorbidity. They have extraordinary levels of need. They are entitled to coverage, but it is a different kind of coverage at the moment of need from what the norm requires.
The professional standard of care considers both their individual needs and those needs against how a professional a prudent professional working in the area would consider treatment for that individual patient.

There are some people who have charged that the professional standard is a static standard. That somehow it is going to retard the development and application of best evidence of evolving medical practice. I am quite frankly puzzled by this because that is precisely the opposite of what the professional standard does. When courts and other decision makers apply the professional standard, they are looking for the highest level of practice that we can expect.
And indeed, there are cases where courts have set aside the industry standard because it did not meet the professional standard. It is not a means rubber stamping the industry standard. Now, most insurers today actually still use the professional standard in their insurance contracts and I have attached to my testimony a number of excerpts from actual insurance contracts. We see these excerpts as part of cases challenging coverage denials. There are a couple of insurers, you will see in the definitions that I have given you, that have moved away from the professional standards, they are using extraordinary standards. They are using standards that no professional would accept that I would guess Dr. Brook and Dr. Wennberg would be horrified to think through, nor could they even design the kinds of studies that you'd want to design to apply to standard.
For example in Doll Elmers (sp) vs. Mutual of Omaha, the standard that is articulated in this contract is that care is appropriate and consistent with the diagnosis is in accord with accepted standards, so far so good, is not considered experimental which is very common. And third, could not have been omitted without adversely affecting the insured persons condition or the quality of the medical care. Now, I seriously ask you how many of you would want yourselves or your children covered by a professional standard where the coverage, or the insurance standard, where the coverage triggers only when not providing the care would adversely affect the quality or the person's health or safety? This is very different from the professional standards of care that are developing from cutting edge projects to improve the overall standard of care.
What the insurer is saying is that it doesn't care what Dr. Brook does or what Dr. Wennberg does when it comes time to make that individual coverage decision. It's going to have the right under its contract to withhold care unless the safety and health of the patient would be compromised. Now, there are those who say that the answer to this is more consumer bargaining. What I have just read for you is not a publicly available document. You wouldn't know as a consumer, that this is the standard that the insurance company is using. Nor would you know as a consumer, that many insurers put limits in their documents regarding what evidence they will allow to be taken into account when they decide a case.
They will exclude, and there is a case cited in the testimony, exclude evidence of that comes from the physician. They will not consider the individual patient's medical records, they will look at their own internal life practice guidelines. And this catches consumers not only in the internal appeals process, but when they attempt to go to court because courts take the view under ERISA that if you didn't develop the evidence in the record of the hearing that you can't usually admit it on appeal. So, essentially consumers are excluded at that point from expanding a record. States have tried to deal with this issue. In the most famous case coming from Texas last year, Texas' law which would have actually allowed much closer scrutiny of coverage decision making was overturned as file would've ERISA. In my opinion, there are really two things you need to do in legislation, one of them is to articulate the professional standards. By articulating the professional standards, you actually deal with the merger of coverage and care, you deal with the question of informed consent because it is simply unacceptable in today's world to practice medicine without obtaining the informed consent in the involvement of the patient. You also need to deal with the issue of evidence, you need to make clear what evidence must be considered in deciding medical necessity it cannot be only the generalized practice guidelines. At some point, the individual's patient record and the opinion of the treating physician at least needs to be considered. And finally you have to be clear that the patient who takes an appeal has access to the evidence that was used against the patient to decide or deny to coverage. Thank you very much.
SEN. JEFFORDS: Thank you, our next panelist is Dr. Linda A. Bergthold, who is the Project Director of Decreasing Variation in Medical Necessity Decision Making at the Center for Health Policy, Stanford University. The project is funded by the California Health Care and Sierra Health Foundation. Dr. Bergthold is also an independent consultant working with public and private sector clients. Bergthold has been published widely on benefit design, technology assessment, and medical necessity. And is the author of Purchasing Power and Health Visits the State and Health Care Politics. Thank you and please proceed.
DR. LINDA BERGTHOLD: Thank you. In my written testimony, I outlined some of the history of the terminology medical necessity particularly as it has become more public since its discussion during national health reform about six or seven years ago. What I'd like to do at this time, however, is talk a little bit more about the findings from the project that we're engaged in right now. Because we, in California at this very moment, are struggling with whether there is professional consensus on how to define medical necessity and how you would actually apply it in managed care plans. I wish our project was finished in a couple of weeks, actually a little over a month we would probably be able to give you some more definitive feedback and we will do that.
When we began our research, we thought the way that medical necessity was defined was the most significant variable. However, as we have gone further into our research we've discovered that in fact, the process by which decisions are made in managed care is far more important to understand and to improve than the terminology that you use to describe those decisions. It's true that neither physicians nor consumers truly understand the process by which these treatment requests are made within their own managed care plans. A treatment request goes out and it's sort of a black box and no one really knows what happens until it comes back as a denial. Who does make the decisions about coverage, about length of stay, about appropriateness?
In studying managed care processes using California, we have found a number of common elements in the process. A lot of things that plans do the same but a great number of variation. Some of the variations are simply organizational anomalies and some of them actually have to do with what we would call best practices. Some of those best practices, I think, can be applied much more consistently as cross-managed care plans. And I'd like to mention a couple of them to you. For example, in California, some of the plans are freely sharing their guidelines, their clinical guidelines, with the physicians, with consumers, and with other constituencies not all but some. Some are gold carding certain providers or procedures by removing barriers to authorization and speeding up the decision making process. Some medical directors regularly call the treating physician before they ever make a denial instead of just sending them a letter. Now this sounds like common sense, doesn't it? But it isn't being applied consistently in the process. And so what we are trying to do is surface some of those good common sense best practices to use the power of the market place to extend those to other plans around the state.
Now along with variations in the process we've found that there is substantial variation in the way that the term is defined and the way it's used. And that's one of the problems that you face today is that there really isn't good professional consensus about what this term means, either in practice or in contract. And while there are legitimate variations, I think, in the definition between say a public plan like Medicare which has different goals perhaps than say a private contract. The types of variations we have found as, and the way they are explained to consumers are really not very helpful either to purchasers or to consumers.
Definitions vary in the same product from plan to plan and I can tell you that the language is neither legally precise or consumer friendly. The variation is of considerable concern to employers, and I assume Dr. Myers will address this issue a little bit later. Because in California, at least, they've indicated to us that they have a strong interest in buying the same product across plans. And they've got this standard medical necessity and it isn't being applied equally so what are they buying for their employees? In looking at a number of different definitions, we have also identified some key components of a definition and we've looked at hundreds of these definitions and they almost all use similar terms. They address purpose of the intervention whether it is to diagnose or treat or maintain or prevent. They deal with scope and they also deal with things like evidence as cost effectiveness, some of them actually deal with cost effectiveness and even the Medicaid plans do have cost effectiveness language in them. And also authority, we call it decision making authority, is it the physician who makes the decision or is it the plan?
Purpose and scope are pretty common and there's a lot of consensus on what they mean. But there is not as much consensus around three elements of the medical necessity definition that you should be aware of. And one is this evidence issue and that is what evidence should be used, should it be what's called the prevailing standard or should it be national expert panels, should it be peer reviewed literature, should it be the treatment physician only, or should it be some combination of those sources of evidence? And then also the second element that's very controversial is cost effectiveness and whether or not plans openly will address cost effectiveness. And we have found that all plans think about cost effectiveness, trading off the effectiveness of one treatment, but whether they actually openly address it is another issue. And then the third is the authority. Who gets to make the decision, when is it the treating physician's authority, when is it the plan's authority, and when did they share that authority? These are the three most controversial elements and they do, and they're controversial because they reflect directly the lack of professional consensus on these issues.
Now the questions that you have before you today are whether medical necessity definitions in law require the consistency in force of med, of federal law. That's the question we are wrestling with now and I wish I could give you a definitive answer about that. I certainly can tell you some areas where I think law does not help and that would be where statute micromanages the clinical relationship where federal statute actually gets between the physician, the patient, and the decision. When statute language is too rigid to reflect what's happening in the market place which is changing a lot and when statute is too far ahead of where the professional consensus lies on any given issue.
I think that federal statutory language sets the tone for practice not just for the courts. And some of the language that we see now in the proposed legislation, frankly I think gives too little credit to the medical profession to make decisions based on the best medical practice.

Generally accepted principles of professional medical practice is pretty vague terminology. And I'm not sure it's an improvement on the status quo which is actually a variety of definitions or no definition at all.
In summary, in regard to the language of medical necessity we hope that you will be somewhat confused as we are right now about how it should be defined. We'd like to leave you with that message and we would recommend that you try implementing something similar to what we're doing in California which is to really go out and pull together all the stakeholders, the consumers, the doctors, the plans, the legal folks around the table which we're going to do next week. And get them to come up with an idea of what a standard should be and then make them come back to you within a date certain with an answer. You can do that, I think. In regards to the language, in regards to the process of decision making, we support your efforts to focus on that frankly. To focus on educating consumers on disclosing basis of evidence on opening up this process to the sunshine. Because in fact there's some very good things going on in decision making in managed care and I think people would be very interested to know more about that. So anyway that you can open up that process make it clear to consumers we think is a good focus for a federal law. Thank you for your attention.
SEN. JEFFORDS: Thank you, Doctor. Our final member of this panel is Dr. Robert H. Brook, who is vice president and director of RAND Health, at RAND in Santa Monica, California. At UCLA Dr. Brook is a director of the Robert Wood Johnson Clinical Scholars Program and is professor of Medicine and Health Services at UCLA Center for Health Sciences. Dr. Brook has authored more than 260 articles in quality of care. His research interests encompass quality assessment and assurance, the development and use of health status membership measurements in health policy, the efficiency and effectiveness in medical care and the variation and the use of selective services by geographical area. Thank you, and please enlighten us.
MR. BROOK: Thanks very much for asking me to testify. I'm just going to talk to you for about five minutes, and try to tell you a little about what I think the problem is in this area. I'm sorry I'm not going to be able to answer your questions, I feel a little bit bad about flying all the way and not being able to answer your questions. What you should do, I think we elected you to do that, and I'm not going to tell you what to do. But I will tell you a little bit about the problem.
I'm one of the few people in this world I think that has spent my life measuring quality of care and necessity of care, developed a lot of the methods to do that clinically. I'm both a practicing physician, I'm on the boards right now at UCLA and flew here to come here taking off from the boards, and I'm a health services researcher measuring quality of care. I think we know what the problem is. The problem is that in studies done over the last 30 years, when you get undressed go see a doctor, that could be me as well, about a third of the things you get probably don't need a definition of being necessary.
You get many things you don't need that are not necessary, and we have methods to measure that. On the other hand about a third of things that you do need, you don't get offered them. You don't even have the right to refuse them, you don't get offered them. And in the written testimony I gave you I have tried to demonstrate that this occurs not only in managed care, it occurs not only in fee for service in the United States, it occurs in the UK, it occurs in Sweden, it occurs in the Netherlands, it occurs around the world, it occurs in the UK. It's a difficult problem that's going to be difficult to fix, and it's been with for at least the last 30 years when people have begun to measure what we call necessity of care.
Now, what is a reasonable definition of necessity of care, what do we mean by that? I think we mean the following things. One, that if I offer you a service, that service has to provide you more benefit than risks. If it clearly has more risks than benefits, that's not necessary. Second, to really be necessary it ought to have substantial benefits. Third, it ought to really be the service that is the best one, there ought not to be any other alternative that we could get away with that would produce a worse outcome, it ought to be the best thing for you. And we like to add another characteristic to that qualitatively, in Southern California we argue it should be something that a physician might want to cry about if he wasn't able to offer a patient that service. And maybe in Massachusetts it would be that it would be unethical to not offer the patient that service.
Now we've used that definition by first taking all the scientific evidence about a procedure or a type of service that we provide a patient and summarizing it, and there's a considerable amount of scientific evidence. Next what we've done is produced multi specialty panels of physicians that have come together to rate scenarios for the use of a procedure. And they may be 2000 different reasons for doing colonoscopy or angioplasty or bypass surgery. And these physicians represent all the different specialties. They've been comfortable with this definition of necessity. They've been able to form consensus opinions about what works and what doesn't. They're not motivated by insurance companies, by managed care, or by money. This is strictly a health benefit and health risk assessment.
And when we put these together, we have produced books for these procedures. And these books contain the science and then the specific indications and what is necessary, what is appropriate, what is equivocal, and what is unnecessary or less than necessary, or inappropriate. And we've ranked all these kinds of things. Now, how are we going to fix this problem that I told you about, that 30 percent or so of the services you get, you shouldn't be getting. And 30 percent of things you need, you don't get.
We've got to reengineer the clinical process. My hope is that what you will do with this legislation is start this clinical reengineering process. If this industry was like any other industry, we would not be in the spot we are in now. I would not have flown from here, from Los Angeles to Washington to come here, if I had to worry about whether the 757 I was on was going to be 30 percent not necessary, or didn't have 30 percent of the parts that it needed, I wouldn't have flown here.
We have an industry that's in a state that needs to have big fixes. I would hope you would begin that clinical reengineering process with this activity. First suggestion, the only one that I really have for you is, you can start with the elective procedures, the elective activities that make up about a half of what we do in medicine. We can go through this process that I described to you, put together the scientific evidence, put together the rating of the scenarios, make them available both to the insurance industry, to people, to the public, and re-change the process by which we deliver care.
Patients ought to have the right to see things. They can understand them. We have given them out to people, and people have written back to us and said, I changed my opinion of what I need after I read this thing. We have given it to doctors, doctors have used them with patients, in terms of doing this. This is a way of reengineering the clinical process to overcome this big problem. I urge you to avoid trying to fix the problem in a short-term way, because you're not going to be able to quickly solve this problem by blaming somebody. I wish it was as simple as the fee for service system is evil, or the insurance companies are evil, or my friends the lawyers are terrible, or even practicing doctors are god awful human beings. I wish there was something that we could blame. It's really not a blaming situation. We have a major problem. We've advanced the science of medical practice to the point where my human mind can't practice good medicine without help.
I need help. I need systems, mechanisms, to help me make better decisions to provide necessary care to my patients. Most doctors feel the same way. We did a survey of doctors in California, and over half of them in managed care said, we desperately need guidelines to help us practice better care. The bottom line is, this ought to be a start in the clinical reengineering process. It will require the investment of federal money to do that. There is nobody else that has the money that is going to do that. The private industry is not going to do this, the pharmaceutical industry is not going to do this, the practicing physicians are not going to come together to do this. But we basically need to start reengineering this process to make it work.
We have a method that you could use and look at and say this ought to be a basis for the beginning and that method can be improved. I wish I could tell you more directly what to do in terms of changing the language of your statute. I would urge that you change this bill into a bill that eventually is going to become the beginning and the basis for reengineering the whole way we practice medicine in the next century. And take advantage of all skills in the clinical science that now are becoming available to complement the basic sciences.
SEN. JEFFORDS: Well thank you for that awesome challenge. I'm not sure I want to call the next panel. If you wouldn't mind, would you just go back and take your seats and we'll have our third panel. And by that time, the vote will have started and we will go and vote and come back and go back to panel by panel for questions.
Our third and final panel of witnesses today consists of representatives of a large managed care plan, a large employer, and the American Medical Association. First I am pleased to introduce Dr. Lee Newcomer, senior vice president, health policy and strategy at UnitedHealth Care, Minntonka, Minnesota. I think I got that right. He is responsible for medical policy for the company and has operating responsibility for Medicare, Medicaid, and small group products. Dr. Newcomer has held a number of positions with UnitedHealth Group. He's been chief medical officer, health care services Department, vice president and health services operation and the national medical director. Before joining UnitedHealth Group, Dr. Newcomer practiced for 10 years in medical oncology.
Dr. Newcomer, pleased to have you here and please proceed.
MR. NEWCOMER: Mr. Chairman, thank you. I appreciate the opportunity to talk about medical necessity. As we do that, we really need to talk about the medical decision making process -- I think you've already heard. Unfortunately the medical decision making process today isn't perfect.
Let me give you a couple examples that help illustrate that. The first one is on the graph that you see right here. In Washington State, 137 physicians were asked to right down their treatment recommendations for a 30-year old woman with an uncomplicated bladder infection. That's the second most common problem seen in offices today. And those 130 physicians in this study came up with 82 different recommendations on how to treat that bladder infection with costs ranging from 3 (dollars) to $4 to as high as more than $250, 137, 82 different recommendations.

A second examples comes from some profiling work that we did this year with 21,000 cardiologists anrnists across the nation using our data bases. We asked a question when our doctors that we contract with saw a patient with a heart-attack, how many times did they give a drug the beta-blocker. Beta-blockers have shown in over two dozen studies to reduce the chance of a second heart-attack by some where between 20 and 40 percent. And unfortunately we found as you just heard from Dr. Brooks that a third of our patients didn't get those beta-blockers.
Dr. Wennberg has recently done a study a couple of weeks ago in the Journal of the American Medical Association for Medicare patients and he discovered that half of them didn't get beta-blocker.
We need to improve our medical decision making process and there are multiple ways to do that. Medical necessity is probably a minor, but important part of that process. Let me tell you just a little bit about how we use that language and what we are trying to do with it. First of all, the criteria that we use in our company are not in a black box. They are open to any physician and we will freely send those out to any doctor that we work with. Secondly, we don't write them. We get our information from the same place that everybody else does; the medical journals. We get them from the agency, from the health care policy and research. We get them from the AMA clearing house for guidelines.
And another important thing to remember here is that we are only dealing with a very marginal amount of the care rendered in the United States. There is a study written by some Harvard researchers, one of whom was Dr. George Lunberg, (sp) the editor and chief of JMA and that study did a careful telephonic interview of doctors saying how many cases do you really have denied? The answer was less than 1 percent. So, only 1percent of care is actually denied and as you've already heard, since about 30 percent is inappropriate, we are only beginning to scratch the surface. We are dealing with the cases that are very far away from medical standards.
Now, the proposed language that you have in front of you today doesn't really advance our issues or help talk about how do we get to the next level, the 21st century of medical decision-making? If you look at generally accepted practices, which one of these 82 treatments is the generally accepted practice? Which one of those 82 doctors is the prudent physician? I can't answer that question. I think we need to, instead, think about a process that will get us a little bit further on a science basis. The language proposed today is a little bit like the language I hear every Friday night from my teenagers. It's, dad, everybody else does it, it must be okay.
Instead, let's raise the bar to what's the right thing to do, and how can we get as many patients as possible to the right appropriate indication? What we are doing is trying to prevent those few decisions, and they are few, thank heavens, that are completely contrary to science. We do need to improve the decision-making process, and I think Dr. Bergthold has already given you an excellent suggestion, in that a committee that worked together may be the right process here, because there is a lot of confusion in this topic, there is a lot of discussion that needs to occur amongst medical professionals.
Thank you.
SEN. JEFFORDS: Our next witness is Dr. Woodrow A. Myers, Jr. Director of Health Care Management at the Ford Motor Company in Dearborn, Michigan. In this capacity, he has management responsibility for the Ford health care benefit for active and retired Ford employees, as well as for workplace safety, occupational health, workers compensation, and disability benefits issues. His previous experience includes service as New York City Health Commissioner under former New York Mayor David Dinkins. Preceding his tenure at the New York City Department of Health, Dr. Myers served as Indiana State Health Commission and Secretary to the Indiana State Board of Health.
In addition, he was Associate Director of the Medical Surgical Intensive Care Unit and Chairman of the Quality Assurance Program at San Francisco General Hospital. And an Assistant Professor of Medicine at the University of California, San Francisco.
Dr. Myers.
MR. WOODROW MYERS: Thank you very much, Mr. Chairman.
As you stated, I'm the Director of Health Care Management for Ford Motor Company. In the United States alone, Ford provides quality health care benefit coverage for about 640,000 employees, retirees, and dependants. In 1998, Ford's total cost in the United States was over $2 billion, and is likely to increase in 1999. I appreciate this opportunity to discuss medical necessity in Ford's commitment to quality health care benefits. As you indicated in the biography, I'm a physician. My medical background in internal medicine, with a specialty in critical care.
My public health background was in New York as commissioner, and the state of Indiana. I've had substantial experience as a practicing physician working with very sick, very scared patients on a daily basis. Discussions on medical necessity go to the core of this relationship between physician and patient and have catalyzed the committee's debate over the need to legislate a definition of medical necessity. While I understand that some physicians think hat any challenge to physician authority and decision making is wrong, I believe that some challenges to physician decision making can be justified by concerns for the quality of care of the patient.
First, as the report issued by the President's quality commission indicated, the health care industry is plagued with over-utilization of services, under-utilization of services, and errors in health care practice. Second, this report also indicated these quality problems are not new and not unique to any type of health plan, whether fee- for-service, or managed care. Third, the practice of medicine in always evolving and new treatments are constantly being developed.
It is possible and reasonable for very good physicians to have legitimate disagreements on the best treatment to be used for disease. And each treatment may have validity under special or a specific set of circumstances. This is not a case of good versus evil. This is a case of good versus good. The challenges to strike the right balance between sufficient autonomy to protect patients from cost- driven strategies that inappropriately can strain care, while avoiding the disadvantages of unfettered physician autonomy that can result in arbitrary, non-evidence based, cost-ineffective decisions.
At Ford, we believe that market-based strategies and processes that can respond quickly to health care changes continue to be the best approach, along with accelerated advances in evidence-based medicine. In sum, we fear a congressionally mandated definition of medical necessity, and therefore, do not support it. We are concerned that such a mandate could impede efforts to improve quality through the use of evidence-based medicine, especially, if tied to generally accepted principles of professional medical practice.
The problem is that some will interpret this language as a ceiling, and therefore, will choose to avoid the provision of newer, more effective therapy with potentially better outcomes is either not required or perhaps too expensive. Others will interpret it as a floor that would entitle the patient to any therapy that falls within the bounds of accepted medical practice irrespective of outcomes or cost effectiveness.
Thus, when medical necessity becomes an issue, Ford could lose the opportunity to target only the best medical services available. This is unacceptable because for Ford health care management, health care quality is job one. As a purchaser of health care benefits for our employees, retirees and their dependents, our objective is to provide access to high-quality heath care services regardless of whether the patient is a member of a HMO, PPO, or a traditional plan.
For example, any health plan that wants to contract with Ford Motor Company must be accredited by the National Committee on Quality Assurance, NCQA. Since NCQA ratings cannot be used for traditional fee-for-service plans, we have provided a leadership role with other major employers in the Detroit area in developing a means of comparing hospitals based on cost outcomes and patient reports of care. This effort is expanding this year in collaboration with the American Hospital Association defined by their geographic areas.
Of equal importance to collecting measures to rate quality, we consistently communicate the importance of improving quality of care, both to our plans, and encourage our members to use the quality of information we provide in making enrollment decisions. We have formed an alliance with the health services research divisions of several academic health centers to help us with our health care data analysis, and we call that the Ford Health Care Quality Consortium.
We believe our system works well and permits both our carriers and our medical staff to exercise their best judgement regarding medical necessity, but we're certainly concerned about others who do not enjoy these assets; in particular, the 43 million Americans who have no health insurance.
In conclusion, we believe we need a stronger national commitment to the measurement improvement and maintenance of high-quality care as was recommended by the President's quality commission. The Congress has an important role, not only to protect patients, but also to stimulate research and assist in the dissemination of that information. This committee's wisdom in improving a substantial increase in the funding the Agency for Health Care Policy and Research, AHCPR, last year was a tremendous step forward in this commitment. Consistence with that approach, we believe you should not tie the hands that helped your organizations by legislating a definition of medical necessity that will return to the age of unfettered autonomy.
Thank you, Mr. Chairman.
SEN. JEFFORDS : Thank you, Dr. Myers.
The final witness on our panel is Dr. Richard F. Corlin, Speaker of the American Medical Association House of Delegates. Dr. Corlin is a gastroenterologist --
MR. MYERS : Close enough.
SEN. JEFFORDS : -- good try -- in private practice in Santa Monica, California. Dr. Corlin has been active in the AMA for the past 18 years, including nine years as a member and then chair of the AMA Council of Long-term Planning and Development. He served as chair of the AMA Study Committee on hospital medical staff, among other positions.
Dr. Corlin was invited, by then Secretary of Health and Human Services, Dr. Lewis Sullivan (sp) to serve as a member of the Advisory Committee (who?) director of national institutes health, among his professional affiliations with that of an assistant clinical professor at the University of California, Los Angeles School of Medicine.
Dr. Corlin, it's a pleasure to have you with us and please proceed.
MR. CORLIN : Thank you, senator.
In the current discussion of managed care reform there's no issue more pressing than the question of who determines medical necessity, and how it is determined. In fact, virtually every other patient protection turns on this critical issue. Consider for instance, a couple of the most widely discussed patient protections, those of external appeals and anti-gag practices. The AMA supports grievance systems that have rapid internal and external appeals processes. Regardless of how sound and effective these processes are however, an arbitrary medical necessity standard would render them meaningless, because if the plan can arbitrarily dictate what treatment is considered medically necessary, the patient will never be guaranteed a fair objective evaluation of the appropriate level of covered treatment.
Allowing plans to arbitrarily define medical necessity would also render gag clause prohibitions totally ineffective. Gag clause prohibitions are intended to guarantee open communications between patients and their physicians. How helpful to patients would communication be if the plan, using it's own arbitrary definition of medical necessity could deny the medical treatment. The AMA believes that medical necessity decisions are ultimately medical decisions, and must continue to be treated as such. Indeed, they are defined in many other areas of law as medical decisions and evolve over time.
I do some of the work that I do testifying as an expert witness in professional malpractice litigation. And, one of the things that often happens when a case may hit the courts in 1999, based upon an incident in 1993, is a distinction between what were standards in those two years. And we don't apply standards today to what happened in 1993. So, the statements made that defining medical necessity would some how or other inhibit medical progress is ludicrous, and has no basis whatsoever. Those decisions cannot be made according to financial or cost factors, as health plans are imposing at the present time.
The AMA in December of 1998, articulated it's policy in this regard by describing medical necessity as follows: health care services are products that a prudent physician would provide to a patient for the purpose of preventing, diagnosing, or treating an illness, injury, disease or it's symptoms in a manner that is one, in accordance with generally accepted standards of medical practice, two, clinically appropriate in terms of type, frequency, extent, sight and duration, and three, not primarily for the convenience of the patient, physician or other provider.
There are three essential aspects of this policy that I would like to draw your attention to, the who, the what and the when. The who is the AMA believes that a properly qualified prudent physician, not any physician, not necessarily the patients physician, but a prudent physician must determine medical necessity.
These physicians should be of the same specialty as the treating physician and actively practicing medicine and have significant familiarity with the patient's specific condition. This prudent physician standard both medically and legally is an objective standard and is not subject to the abuses of the plans alleged.
Most importantly, physicians reviewing medical necessity and external appeals must be independent of both the plan and the treating physician. We are not advocating that the treating physician be the ultimate decision maker to write any orders that he or she wishes, rather we're advocating that independent properly qualified and licensed prudent physicians make the final and binding decisions.
The what means that the standard being applied must be clinically appropriate and accordance with generally accepted standards of medical practice. It must use specific medical review criteria and processes that afford clinical peer to peer review. This is how medical necessity is traditionally been determined because it has been correctly considered a medical decision, not a black box decision based upon accounting principles. You know, we're used to the term black box and the airline industry when there's a God-awful tragedy and everybody is killed and people go to open up the black box to find out what happened. We don't want that same process to go on in health care decision making.
The when describes the type of information that may be used to review medical necessity determinations. Only information that was available at the time the treatment or services were provided must be used to review these decisions. Denying treatment coverage based upon information that wasn't available until after the treatment was given is patently unfair and doesn't provide good medical practice.
Like our patients, the AMA is concerned that permitting health plans to define medical necessity will allow them to deny care to which patients are rightfully entitled. Consider the language of some plans already. Medical necessity according to one plan is based on quote, "the least costly alternative of supplies or services available." Here's another one quote, "the shortest, least expensive, least intensive level of treatment and consider the stark implications of this one quote, "the ensurer will have the sole discretion to determine whether health care is medically necessary."
Our patients need your assistance in retaining medical necessities and medical decision. It needs to be decided in accordance with generally accepted standards and medical practice as is clinically appropriate by properly qualified prudent physicians.
Thank you very much, for allowing to make this statement and hopefully during the question and answer session to follow, there are a few points that I think are important to follow. When is a high percentage of negative tests ordered for a certain condition valid? There are certain circumstance and we need to draw, not necessarily the specifics, but the basic principles involved in that.
Medical necessity is not a concrete issue. Medical necessity is stated as well defined in other areas of law. What is the proper role of patient choice in comparison to medical necessity? Medical necessity doesn't change based upon patient choice at all, but the application of medical care is a combination of medical necessity and patient choices. We need to address those.
And finally, as the very excellent point that Dr. Newcomer raised about the variations and treatment of urinary tract infections, we're getting into substantial areas of quality that are best left for education, not legislation, and I would strongly encourage your committee to consider inviting Dr. Brent James (sp), from (Innermountain?) Health Care in Salt Lake City to discuss the method that he has used in a totally non-regulatory, non-punitive means of educating physicians to get this 87 different treatments down to maybe 4 or 5 that are clinically appropriate.
And thank you very much for asking me to appear.
SEN. JEFFORDS: Well, thank you all. I will now recess the committee until 10:50, to give you an exact time. And then we will go back to Dr. Wennberg and start there and proceed on forward.
Thank you, and I'll see you again shortly.
SEN. JEFFORDS: Thank you. The Health Committee is back in order.
Obviously, it's been a more interesting morning than I wanted, with respect to all of your testimony. But I am so pleased that we have such a imminent experts and witnesses to be able to help us through this very difficult task. So, we will now go back to Dr. Jack Wennberg, and you described evidence-based medicine as very different from the term generally accepted principles of professional medical practice. How would a statutory definition of medical necessity based on generally accepted principles of professional medical practice impact quality of care?
MR. WENNBERG: It probably wouldn't affect the quality of care much, because in a sense that it seems to me that what we basically have under that construct is the concept that local determinations of medical necessity are the correct determinations. And that's the way the system works now.
So, if we're looking for a positive impact on the quality of care, we're going to have to move towards more evidence-based medicine and medicine that is more directly based on patient preferences. I keep needing to emphasize the fact that modern medicine provides many options in a clinical situation. These options have different impacts for the patient depending on which choice is made. And those options, generally, go around issues of tradeoffs and the quality of life for the patient. We need to involve the patient in that choice.
So, if we're talking about a reform process that wants to improve the scientific basis, that is to say you learn the relationship between health care inputs and outcomes and improve the role of the patient in medical decision making, leaving the current system in place, basically, will have little impact on the quality.
SEN. JEFFORDS: Today, we are discussing legislative language that sets a standard for medical decision making and defines boundaries for plans and treating physicians in the process. Shouldn't we be thinking about how the patient fits into these decisions? And if so, how can we ensure that a patient is provided with the best information to make the choice that is best for him or her?
MR. WENNBERG: All right, well, quite clearly, the model decision making that has traditionally been used says that the doctor decides for the patient. That's based on, historically, it's based on the assumption that medical information is too complex for patients to understand and that providers, mainly physicians, can make the decision for the patient based on clinical judgement and the individual provider's own insight into what the patient really wants.
Clearly, that no longer works. I cited in my testimony the situation with breast cancer, where medical science makes clear that the main outcome is exactly the same. But the choice of treatment, whether a lumpectomy or a mastectomy has very different other outcomes. And those all impact on the patient's quality of life. And we know from studies that patients evaluate those outcomes differently.

So, what one person wants, another does not want. And we need basically, therefore, to move from a decision-making process that has depended primarily on the physician's judgements about value to one in which the patient is involved as an active participant.
We call this shared decision making and there is a number of examples, both in the medical literature and in progress where we learn clearly that when patients are actively involved in decision making, they choose differently than when physicians prescribe care for them. And it turns out that not often or commonly, the patients are more at risk adverse than physicians, and will choose more conservative treatment. This is not so much in the case of breast cancer, but it's been clearly shown in prostate surgery and by-pass surgery, for example.
SEN. JEFFORDS: I know that you did some of your initial work at the Rutland (sp), Vermont, hospital, on practice variations. What are the quality implications for patients of practice variation?
MR. WENNBERG: Well, it means that what you get depends on where you live more than the disease you have or your own preferences for treatment. So, that seems to me to be a fairly profound significance since the common assumption is that when one seeks medical care, one gets treatment prescriptions that are based on generally accepted scientific principles, and on the concept that this is the only choice I have.
That's what's behind the variations, the failure of that model to work. So the impact is quite significant. If we're looking for a health care market in which patient demand actually drives utilization. As it is now, in many examples, the supply in its sheer quantities, for example, the number of hospital beds, or the difference of opinion about the individual physician concerning what is the preferred practice of medicine. These two factors, practice style and supply, pretty much drive the variations that we see across the United States and indeed throughout the state of Vermont.
Our original studies, incidentally, were for the whole state. We compared Burlington to Montpelier, and so forth. And at that time, for example, we saw tonsillectomy rates in Morrisville (sp) were such that 60 percent of the kids were getting their tonsils out. And then, in Waterbury (sp), where I happen to live, it was like about 20 percent. And in Middlebury, it was 3 percent. And all these differences were traced to difference in local opinion concerning the efficacy of a tonsillectomy.
SEN. JEFFORDS: One of the things we'll be doing with the design of (ACPIR?) on how to figure out how outcomes, research, and all of these things can be utilized in this process. So, how do you envision that as we go to the future and we have much more information on outcomes as to fitting in with these definitions, and how should they be utilized?
MR. WENNBERG: Well, let me say first that, as much as I appreciate the committee's efforts to increase the attention funding levels to ACPIR, the problem we're talking about here, in terms of the large uncertainties in medical science, are a much more significant problem than that agency now has the mandate to deal with. They're off by an order of magnitude, in terms of the funding level.
SEN. JEFFORDS: Right, I understand that. And that's one of the priorities for me personally, and I think this committee, is to get to the funding up so that we can maximize utilization of that information.
MR. WENNBERG: I think that the other point, however, is that the NIH is beginning to understand that part of its responsibilities with scientific basis of medicine includes clinical research on outcomes. And so, I think paying attention to increasing that use of that resource is also, would be very important. As far as the use of information, or the feedback from information, there are many efforts going on right now. Dr. Brook mentioned one strategy for basically trying to come to terms with what's known and not known about the outcomes of different treatments. This is one example of evidence- based strategies.
The more clinical trials we have, the more we move from expert opinion to scientific evidence that's firmly established. And it's important to keep the distinction between expert opinion and evidence that's based on scientific outcomes research clearly in mind. And finally, what one needs to do is to get this information available in understandable ways to the individual patient at the time the decision is being made. In other words, we need to inform patients who are facing a breast cancer decision and objectively what the options are, what the significance for their lives are of the different options. And I know that in our own research, we've been doing this with interactive video presentations, which convey both the scientific information as well as the situation, that the dramatic situation that women face in these situations with women testifying to their own decision as to why they chose lymphadenectomy and another woman, given the same story why she chose mastectomy. And those kinds of empowering scenarios have been very effective in involving patients directly in the choice of their treatment. And we know further that when this happens the choices will more accurately reflect what the patient wants. And remember these are very individualized differences. And in the case, as I mentioned, in the case of some forms of surgery, the decisions that patients make are actually more conservative than those that were being recommended for them by their providers. So, there's this constant relationship between Alkins (sp) research feedback to patients and finally we need to follow up patients according to their choice of treatment to find out what the outcomes are. So, it's an iterative ongoing strategy.
I might mention in the case of prostate cancer where we have no clinical trial information about the outcome and it looks like the preferences of patients and doctors are so strongly felt, it's almost impossible to organize clinical trials in that field right now. The best strategy may well be the judicious and conscientious and complete follow up of cohorts of patients who are actively choosing their treatment between radiation, surgery, and decisions that many men will make, some men will make basically not to have any active treatment because of the side effects.
SEN JEFFORDS: Thank you.
Doctor, uh, Dr. Collins, Senator Collins.
SEN. SUSAN COLLINS (R-ME): I like that promotion.
Thank you, Mr. Chairman and thank you for holding this very important issue on the question on medical necessity. I think that all of us can agree that important medical decisions should not be made by accountants whose sole concern is the bottom line but rather by physicians in consultation with their patients. However, I'm very concerned that a congressional mandate that defines medical necessity could actually undermine our efforts to improve the quality of care through evidence based medicine.
No one wants to minimize the role of the treating physician and indeed the treating physician must play a central role in treatment decisions. However, it's evident from the studies that have been done by Dr. Wennberg and others that patients can go to different positions, be told different things, receive different treatments and receive markedly different care.
Moreover, even if something is consistent with generally accepted principles of professional practice, it may not necessarily be medically appropriate. For instance, the centers for disease control estimated that physicians performed 349 thousand unnecessary cesarean sections in 1991. Similarly, in a more recent study that was published in the Journal of the Medical Association there were noticeable geographic variations in the therapies used as a measure of quality treatment after a heart attack, indicating that key treatments like aspirin and beta-blockers are being underused. As a consequence there may indeed be valid reasons to question the assumption that an individual practitioner's decision is necessarily the right one. Our goal, Mr. Chairman, ought to be to put the patient first, and to have an emphasis on outcomes and the best quality care. And that's why I'm particularly interested in the work that Dr. Wennberg has done. I feel I have two ties to Dr. Wennberg. One is that my uncle, Doug Collins was the first director of the Dartmouth, Maine Family Residency Program in Augusta, Maine. And in addition, I've followed and been very interested in the work done by Dr. Bob Keller of Maine with the Maine Medical Assessment Foundation, which has worked closely with Dr. Wennberg and been inspired by that work. And that's focused me very much on outcome, and on the fact that we still have so much to learn.
You mentioned, Dr., in your testimony your study that found significant variations in the way that patients were cared for at the end of their lives. And the study seemed to conclude that the determination of whether or not an elderly patient died in the hospital probably had more to do with the supply of hospital beds then it did the patient's needs or preferences. Is there any indication that patients are becoming more actively involved in medical decision making particularly with regard to end of life care and does that indeed, the patient being involved, have -- make a difference in where the patient dies?
MR. WENNBERG: Thank you for that question. This is a very important problem, end of life care. As I mentioned we have huge differences in the chances for example of dying in the hospital under active treatment where it'd be upwards as I remember 45 percent of deaths in some communities and as few as 15 (percent) in others. And the problem is indeed capacity related, in a sense that if you have resources available, patients are sick, desperately sick, the more is better philosophy that permeates American medicine dictates the standard of practice is to use available resources.
Unfortunately this is all done outside of the context of whether this actually improves life expectancy. In this particular case, of course, we're not talking about life expectancy. But the intensity of care that I've described for you in the last six months of life occurs across all stages of life in a community. And our studies clearly show that communities that have more intensive strategies for dealing within the life care do not have all other things being equal, do not have better survival. In other words, we're on a very flat piece of the curb and there's no evidence of medical pro-activity across this very wide range of medical activity. I think, I remember in Portland, Oregon where we were spending 4.5 days in the hospital in the last six months of life, the average expenditures under Medicare Part B for that population was only less than $5 thousand per person; in Manhattan it's $16 thousand per person on a price adjusted basis. I mean there's not just differences in cost, that's purely utilization variable.

So, clearly when patients are faced with their own preferences about end of life care, and we know that patients have strong viewpoints on this and many patients would prefer less intensive care. What we see in fact is that these preferences tend to be overridden by local capacities of the health care system. And this was shown dramatically I believe in studies that JoAnn Lynn (sp) conducted, the so called support studies in which a randomized clinical trial, if you wish, was done to inform patients effectively inform not only to inform the patient but also to try to rearrange the practice patterns by informing the physicians and so forth about the preference of the patient for end of life care. And what the result showed was basically no matter what the preferences were it was the practice style locally that determined whether or not end of life care occurred in intensive care or in the hospital.
And finally, when we reanalyzed the support data, we got measures of local hospital capacity. We could see that the variations between the difference sites in that study were in fact closely predicted by the local hospital capacity. So coming to terms with this role that the overall capacity of the system plays in influencing the thresholds for medical interventions, here we're talking the last six months of life. But this has a lot more to do with that care than just this.
Coming to terms with this threshold affect is extremely important if we're ever going to understand why cost varies so much between communities. And also why it is that so much of medical care escapes medical necessity arguments because we're talking here about the interval, say between revisits to a doctor, how many physicians do you see in the last six months of life, what's the visit rates? In Miami as I said, 48 visits per person in the last six months of life, in Minneapolis, 14, in Miami approximately 35 percent or 34 percent of people see 10 or more physicians. And in Minneapolis it's about 8 or 9 percent.
So these sheer intensity problems are behind the variations. And behind that yet is another question of patient preferences, which tend to get swallowed up in this huge drama that's going on, called health care.
SEN. COLLINS: I'm going to send you some legislation that Senator Jay Rockefeller and I are sponsoring on end of life care, which I'd love to have you take a look at. Let me ask you two other questions that follow from that. One is in the work that's been done in Maine on caesarian rates in different geographic areas where there was a huge variation, the Maine Medial Assessment Foundation found that by going and talking to the physicians who were the outliers that they could change their practice patterns. And thus help women to avoid unnecessary surgery, unnecessary risk, and unnecessary cost. Do you think that utilization reviews, therefore, can help reduce variations in practice patterns and thus lead to an improved medical quality of care? The reason I raise this is utilization reviews are now often seen as just to control cost, when in fact, they can actually improve care, it seems to me, but you are the expert and I am not.
MR. WENNBERG: Well thank you for that question. I have to say that the Maine Medical Assessment Foundation is a wonderful event in my life. Dan Hanley (sp) who I think you also know started this in the mid 70s after publishing papers from our studies showing these variations. And then Bob Keller took over that organization later. And my son David, who is now a physician at the Maine medical center, now works with Bob Keller. So there's a lot of personal connections over there.
What the main medical assessment program shows you is that if you have in place an infrastructure in a region for gaining the respect of the physicians, gaining the respect of the employers and perhaps even the insurers. You can essentially create a strategy for dealing with variations that is focused on outcomes and focused on patient preferences. I must add now that a group is beginning to use strategies for informing patients about elective surgery options, which accomplished my second problem here.
Problem number one is doing something. Does it work? Problem number two is do the patients want what works when more than one thing works? It's really important to get that across.
Yes, definitely, quality of care can be improved this way, independent of the cost issues. And incidentally, the cost implications here have generally been quite positive within a specific example of the procedure, which is being addressed. But from the point of view of the overall cost, the problem is that because there's other things that people can do, physicians can do, the overall cost has not been impacted directly by this. What's been directly is the avoidance of unnecessary care, the kind of care that Dr. Brook would call inappropriate through this strategy.
That's just another statement to say you've got to pay attention to capacity and the overall aggregate quantity of resources that are available in a region to take care of patients if you're going to deal with the overall cost problem.
SEN. COLLINS: My final question concerns an article that appeared in last Sunday's New York Times that was entitled, "Managed Care's Other Problem. It's Not What You Think." It was a very interesting article. It concluded that contrary to popular belief, and I would say the belief of many members of the Senate.
The problem is not too many medical treatments. I'm sorry. The problem is too many medical treatments, not too few and that managed care plans are in actuality denying very little care. In fact, this article raised the issue of whether or not managed care is achieving its goal of having utilization reviews that are effective in stopping unnecessary treatments that could be harmful or risky to the patient. And that there's been a reluctance by managed care plans to review physicians who fail to follow the best medical practices, and the result may be needlessly risky surgery, unnecessary and costly tests. It cited a particular study that showed that surgeons perform mastectomies rather than breast preserving surgery on Medicare patients, 35 times more often in some parts of the country than in others for no apparent medical reasons.
MR. WENNBERG: Right. Of course that's the study I was referring to in my testimony. It may not have been clear, but the variations that we saw in use of breast sparing surgery were that great from one part of the country to the other. The focus, however, of your question was about whether managed care is not doing its part or is afraid to do its part in terms of reducing unnecessary care.
I don't have any direct information that I would like to tell you about with a specific answer to that. However, there is a very specific example of how an HMO constructively was able to determine what was the necessary level of care for prostate surgery.
In my written, I've actually included some information on this, but in the early '90s, the chances that a man would have surgery for benign prostatic hyperplasia, we're not talking about cancer, but this is a benign condition, varied five fold between places. For example in Maine, we knew in some regions that 60 percent of men were having this operation by the age 80 and in others it was like 20 percent, to give you an example.
Well, these two HMOs, Group Health Cooperative in Seattle, and Kaiser-Denver decided that they would implement a strategy for systematically informing their patients about treatment options for this condition. Based on outcome research and the interactive video you mentioned which we'd actually done as a research product.
One thing we found out was that men made much better decisions after this. Previously, men were not getting the stories that treatment of this condition was a tradeoff between, if I may use the expression, "peeing better and sexual activity." In other words, you could get the surgery and you have the best chances of having your urinary tract symptoms relieved, but if you had the surgery, you had a change in sexual function, called retrograde ejaculation, and some men became incontinent, that was not a great story. But the point was, these tradeoffs are real. And they depend on how much your symptoms bothered you and how much you're concerned about it. And it turned out that once information was in the market, people became aware of this, the decisions changed to a (reductionist?) idea of increasing urine flow, which was the general rule at that time of why you were doing it, to a tradeoff between symptom levels, which you could achieve some relief by doing nothing, because it was a very kind of up and down condition, or using drugs, pharmaceuticals.
And the interesting thing was that this, then, in my definition of medical necessity and appropriateness became the right rate, the rate that the informed patient wanted, given the options that are in the benefit package. Interestingly, these two HMOs had rates that were about the 30 percentile in the nation, they were not the lowest. After the decisions were turned over to the patients, the rates dropped 40 percent, to the bottom of the US distribution rates, suggesting that under the informed patient decision-making model, the amount of surgery now provided, at least provided at that time in the United States, for this condition, greatly exceeded the amount that informed patients wanted.
So, here's this distinction between medical appropriateness, in the sense of things that work. Surgery works very well to do one thing, it has a secondary problem, and what the informed patient wants. And so, if I were to go back to your question about health plans are in a good position to implement this strategy, perhaps better so than fee for service medicine. We did not, however, see that, except in research examples.
And that would be one of my reasons for recommending to the committee that if you go into the question of medical necessity, and you define it, that you add to it what's generally accepted medical practice, and what informed patients want, because then you have a standard which actually may begin to influence utilization in ways that otherwise are not possible. The problem of implementing shared decision making, of course, is another whole story. But I don't think this hearing is about that.
SEN. COLLINS: Thank you.
SEN. JEFFORDS: Thank you very much, doctor.
MR. WENNBERG: Thank you, Senator.
SEN. JEFFORDS: Senator Kennedy.
SEN. EDWARD KENNEDY (D-MA): Thank you, doctors. Excellent testimony, and very thoughtful and I would certainly hope that whatever we do, we would include this concept.

And I thank you for the language suggestions, as well.
I just had one question. Would you agree that in the case of a dispute between a health plan and a patient, you know, over whether a recommended procedure is medically necessary, the ultimate judgement should be based on what the best experts in the field and the scientific evidence indicates is appropriate.
MR. WENNBERG: Clearly. In other words, patients should not have care that doesn't work or is harmful.
SEN. KENNEDY: We had, and I'll just wind up, in one of the plans, without naming the company, it says the company will have the sole discretion to determine whether care is medically necessary. If the care has been recommend, provided, prescribed, or approved, a physician or other provider will not establish the care as medically necessary. That's just one plan that, but your sense is the final judgement is what the best experts in the field and the scientific evidence concludes
SEN. KENNEDY: And what the patient wants. I really would add that.
MR. WENNBERG: Yes, absolutely.
SEN. KENNEDY: I think you've made a very persuasive case. I think that that's been very, very helpful.
SEN. JEFFORDS: Thank you very much, doctor.
And all of you will be -- let you know we may be back to you for questions in writing. And now with the second panel, if they would please take their seats.
And my first question is for Sara Rosenbaum.
Do you think that a federally mandated definition of medical necessity would cause plans and insurers to draft their contracts more narrowly with more specific exclusions to avoid increased costs or potential liability?
MS. ROSENBAUM: I think it is certainly to the extent that the federal government were to say that it wants to put a floor of essentially professionalism under whatever is covered in the contract. A plan would have to be clear. Now it happens that last night when I taught health law, I used as an exercise in my class, a page from a contract that had 20 listed exclusions. And one of my students who works for an insurer actually who was in the class, when the students saw this they were just appalled. They said we can't believe there are all these exclusions. And he looked around the room, he said, you have no idea, this is short. We have pages and pages of exclusion.
I don't really think that we could go any further down the exclusionary path than we already do today. And quite frankly, in a contract world, you want that kind of specificity in the draft. And there's a separate problem with access to the language. But if you're worried about encouraging a certain kind of conduct by putting a professional floor under what is covered, I don't think you need to worry about that. It's a practice that's already well underway.
SEN. JEFFORDS: Uh, in your testimony you talked insurance company, quote "self-serving practice guidelines," unquote. Have you conducted a survey of guidelines used by private sector health plan?
MS. ROSENBAUM: Uh, that's actually very difficult to do unless you work for a -- in a profession where you have direct access to the guidelines. It is absolutely true that more and more companies are now giving access to, at least a portion of their guidelines. We have no way of knowing if you can see all of the guidelines. There are certain guidelines that are readily accessible to you or me. And those are guidelines developed by companies that develop guidelines for a living, such as Millimen (sp) and Robertson, for example. And you can buy them, you can look at them and some of the guidelines are good and some of the guidelines may not be good. They are developed off of the norms from actual patient records and other sources.
The question I think you're getting to is whether -- what should be good evidence, all right. The real problem that we find ourselves facing at this juncture is that the work to develop guidelines, really good guidelines. The kind of work that Dr. Brook has talked about, the kind of work that Dr. Wennberg has talked about, is a separate issue from the inappropriate use of internally developed practice guidelines. If I needed to make a decision about coverage and I were operating under the professional standard and this where I think all morning, we've been talking past each other. The processional standard is what Dr. Brook does. And if I were a judge in a case, I would be taking Dr. Brook's guidelines. I would be taking the medical records. I would be taking the opinion of the treating physician. I would be taking published reports and studies. The professional standard is not the local practice standard. It has nothing to do with the phenomenon of local practice variation that Dr. Wennberg has documented.
In fact, the locality role was discredited about 30 years ago. What the professional standard is all about is a search using the best evidence available to find the appropriate and specific physician in a specific patient's case. And so in fact, if guidelines used by a company were flawed, were not developed impartially, then in fact those guidelines would not be amicable in court. They wouldn't have the standing of expert evidence -- And that in and of itself, I wouldn't have to worry about keeping them out or not, actually a court would keep them out for that reason
SEN. JEFFORDS: Question for you, Ms. Bergthold, given our current understanding of the issues, should medical necessity be defined by Congress, or would you recommend that we authorize this project similar to California's, quote, "decreasing variation and medical decision making?"
MS. BERGTHOLD: Well, I think we've heard a lot of different opinions today about what should be in the standard but I've watched this debate now develop since about 1993 over what is medical necessity and watched sort of Congress come up to defining it and back off and then come up to defining it and back off. And, it was really for the reason that we put our project together out in California, because the legislature in California -- does that mean I have to stop talking --
SEN. JEFFORDS : You just keep right on -- that's just telling me that, you know, to be fair you'd better let Ted ask a question once in a while.
SEN. KENNEDY: No, go ahead, please.
MS. BERGTHOLD : I mean the light wasn't even on and then suddenly it came on.
MS. BERGTHOLD : Our California legislature was thinking about defining it, and agreed to, impartially agreed any way, to put that off and we could come up with some consensus around our table out there about what we should be in statute. And, I really would recommend to you that you try doing something similar to that here and pull in the experts, give them a chance to talk, give them a chance to look at what's being used, the models that out there and there are plenty of proposed models out there to look at. I would suggest that.
SEN. JEFFRODS : Senator Kennedy.
SEN. EDWARD M. KENNEDY (D-MA) : Thank you very much.
Dr. Rosenbaum, let me ask you, just to follow up on what Senator Jeffords was talking about, what the generally accepted standards of professional medical practice mean. Does it mean what a doctor does or what most doctors do? MS. ROSENBAUM : The generally accepted standard of practice is, it is a legal term of ours. In the context in which it's been discussed this morning, it doesn't have the meaning that's been described to us, it is not simply what doctors do, it is a special process that fact and law finders go through and it has the name, the professional standard. And it has to do with finding what a good practitioner should do, not what any doctor does, which means that as you use the words, generally accepted principles of professional practice, to me, as a lawyer actually it means something entirely different. And you can change the words around and there are four or five or six or 12 different ways the courts have come up with to express the professional standard. Your bill happens to have one of them, but it is not to be read literally, it's like any term of art in the law.
I should note that if you don't come up with a term of art for this, if you simply have no term of art at all and say that the process of reviewing a plans treatment decision shall have an impartial decision-maker and she'll take in evidence and make a decision. You in the end have left people in the position where a health plan could write a contract that says, we cover only those things that our practice guidelines cover. Without any reference whatsoever to the guidelines, how they were developed, whether they're Dr. Brook's guidelines or guidelines developed by company actuaries. And in fact the external review would mean nothing, because you have put no floor on the minimum level of coverage and you end up with a situation that verges on the fraudulent. Somebody buys the contract of insurance thinking that they've bought coverage for something called medically necessary care, and it turns out that medically necessary care is in the eyes of Alice in Wonderland whenever I say, the care is. And that's precisely the problem here, the problem is not retarding advances in the profession, the problem is allowing the substitution of poorly developed practice guidelines contractually for what has been two centuries of thinking about what a floor in health care ought to be when we had indemnity health care insurance it didn't matter. I mean it mattered because you were out a lot of money if the company won't pay. But, you got your care. Today it really has become an health care access issue and my great concern is that the work of people like Dr. Robert Brook's will not be realized by most of us, because our coverage will be whatever the company's guidelines say, which may or may not be what Dr. Robert Brook's has done.
SEN. KENNEDY : So that makes the obvious case that there has be the inclusion of these standards or these -- I mean, the words are important, what they mean, but you know we're obviously flexible. I was listening to Dr. Brook talking about -- the various criteria he was using.

And the question is, is whether you'd include some of those criteria or how we address it, but I understand your position that you have to at least have the basic standard, the floor, otherwise we open up the possibility for irresponsible. I mean, we've got some very good HMOs in my state of Massachusetts, some of the best in the country. But, the point about it is, what we're talking about that there would be at least the opportunity for those that are not responsible to be able to circumvent the most important possibilities that might be available to a patient, in terms of the expertise that could be brought to bare in a particular illness or sickness?
MS. ROSENBAUM : Yes, that is correct.
SEN. KENNEDY : Let me just ask you, how do you respond to the -- I thought the very interesting points that Dr. Wennberg mentioned about whether generally accepted standards of professional practice mean the local standards?
MS. ROSENBAUM : Well, that was where I was quite frankly lost, because the local practice phenomenon, which Dr. Wennberg has documented in the literature, and which I have to say we talk about it and I teach about it extensively, it's one of the major break points in how we understood the American health care system. Has nothing to do with the locality rule. The locality rule is the rule that used to govern courts application of the professional standard. If a doctor was accused of malpractice in the old days in fact, a court or a jury would look to what happened in Rutland, Vermont to decide whether or not the doctor committed malpractice.
Today, the local practice variation may in fact go to the issue of whether there's a national standard. But, the doctor is governed by a national standard of practice and in fact a court and a jury may look to local communities to see whether a physician has access to certain kind of resources. A doctor in rural Mississippi who simply cannot get access to certain things for his or her patient may be held to a ultimately different standard of care. But the issue of the what standard you begin that consideration against is not the locality rule, it is a national rule.
SEN. KENNEDY : Could I mention, I thought I saw Dr. Wennberg nod his head that he at least agreed with that interpretation, was I correct or -- MR. WENNBERG : I think the basic point is that I was agreeing with the fact that the national standard may be meaningless, because they apply, because they don't exist.
My argument here has not been legal definition of whatever this is all about --
MR. WENNBERG : But rather that science doesn't govern the general practices of medical. And in the lieu of that what we have basically, is willful variation of interpretation if you (wish?) Although that's not quite what's going on, you know. National standards basically provide little constraints on what's happening in local market. Therefore, we need to be worried about a little of different problems and that's partially why we're talking, maybe slightly around each other here --
MS. ROSENBAUM : Umm-hmm. (Acknowledge.)
MR. WENNBERG : Coming from a legal prospective, is one thing, coming from a medical prospective it's quite something different. And when we say generally accepted principles, generally that's what the professor of medicine says it should be when we go around. Bob Brook's work is beginning to provide some bases for moving to a national prospective on this.
What I've recommended to you, in terms of providing more and more resources for improving science is so that it is not just based on national experts, who after all then tells me not have the access they need. They're constraining the choice, but they're not certified, unless there's been some very specific --
SEN. KENNEDY : Well, just tell me, the light is on -- what is the point of agreement that you have, what the best experts, with the best science. I mean, can you agree on that that ought to be the kind of treatment that the patient ought to receive?
MR. WENNBERG : You already asked me that question, I think --
SEN. KENNEDY : Well, I know it, but I just want to make sure that this last answer doesn't undermine that.
MR. WENNBERG : Well, I just love to know what you think there's too much science around.
SEN. JEFFORDS : That is definitely a problem.
Dr. Brook, you state in your testimony that doctors need help in clinical decision making and that a recent survey of physicians in California revealed that the majority want guidelines to help them to make better decisions.
How would a statutory definition of medical necessity, based on generally accepted principles of professional medical practice affect the use of guidelines?
MR. BROOK : I'm going to back off for one second. I think the risk on both sides of this statutory to base is as follows: you product a statutory to base a medical necessity that labels virtually everything that the average doctor does is medically necessary, you're going to have an affect of increasing the price of health and care in this country remarkably, you're going to wind up throwing more people off of having health insurance because there's no commitment to have any sort of a health insurance bill in this country and you're going to wind up harming more people because we've established out of research that basically if you lose your health insurance you have a higher probability of dying.
So, if we make the definition of medical necessity that any doctor can do anything to anybody, for any reason, as long as they talk to them, we can radically increase the number of people who have no insurance in this country and kill a hell of a lot of Americans. Now the other side of the coin is, you want to make sure that managed care companies or doctors or anybody else the few of them or maybe the many of them that are going to do something that we don't want them to do, don't deny people things that have necessary care.
There is a method to begin and we don't have to wait 20 years for outcome studies, there's a to begin. We have republic money, with federal money, produce a method to measure the necessity of medical care, we've done it for a multiple number of elected procedures that's the place to start. That's where the most money is right now. You don't start from the very complicated patients in the hospital where it's very, very difficult to deal with that problem. You deal with a lot of it, elected sorts of both diagnostic and surgical procedures.
You review the best science, you get a multi-disciplinary team of physicians to fill in the holes of the science, because we don't have it now, you produce detailed scenarios about what's going, you start with that document at the basis for both the patient and the doctor in the public domain beginning to negotiate care.
Now, there always will be a need that's not a cookbook. There always will be a need for something beyond that. And that need is that there ought to be a right of the doctor and patients, after they start there, to say I have a different clinical reason for wanting to do this. And I need an independent review of that, quickly, not in 20 years, but in one day, of, here is the guidelines, here is where we are. Is this a justification based on a different clinical method? Now, that's a process to get us off the dime.
Just putting something in the legislation, ain't going to do much, as far as I can tell without going sort of beginning a process to do that. That process has to be maintained in the public domain. Otherwise, the companies that are developing the guidelines, whether they're the best managed care company in the world, can't maintain this kind of scientific basis. To produce one of these kinds of guidelines for one procedure is about a half-a-million dollar activity. There is no plan that's going to invest that kind of money, for a 100 or 200 guidelines, and keep them up to date and current, because they can't afford it.
So, there has to be a public/private partnership in trying to get from here to there. There's a method for doing it. I'm not advocating waiting 20 years, because as I showed you with the data, we have a system that needs changed now not in 20 years. There is a mechanism for doing it, and I think it's about time that we begin to implement it. I am scared to death that we implement over this craziness about; yes there are these horror stories. We'll implement a solution to this problem, which will drive up the cost of care to Americans so much, that small business will stop even thinking about having health insurance. People want be able to pay 20 percent of their premiums and will hurt even more people than we currently do now, in the fact that we don't have health insurance for everybody. That's the dilemma you're at. If you came to me and said, I've got health insurance for every American right now, there would be a whole different discussion of medical necessity.
Sorry about that response.
SEN. JEFFORDS: Uh, that's all right, it's helpful and we've asked CBO to help us with this question also. We're going to run out of time, at least out of my schedule, so; this panel is excused, unless you have another question.
SEN. JEFFORDS: Doctor Newcomer, can you give some examples of where generally accepted principles of professional medical practice are different from what the medical evidence indicates?
MR. NEWCOMER: I think we just saw a recent case with the Humana Court Case. And by the way, I need to start by saying, that most of the discussion that we've had about this language, resolves the issues in the court. And I would tell you that, the people, physicians who work for me as medical directors, are have two dozen, three dozen discussions with doctors everyday trying to solve problems about conflicts. And, we don't have time to wait three months to file a complaint, two years to get into court, another year to find a decision. We need to find language and solutions that get us answers on a day-by-day basis, because people don't want to wait the three to four years it would take to go through the judicial system.

So, as we think about this language, I would hope that we could do something that would help with day-to-day operations and use terms that doctors talking to talking doctors can understand. Otherwise, I fear we're gonna both are going to have to have a lawyer by our side as we have the daily discussion in order to interpret some of the standards and the long legacy of history in the legal system. There are standards that simply don't match good science today. One of them I showed you already, was the beta-blocker example. Half the doctors in the United States today, still don't give that drug. It has been a standard of the American College of Cardiology for almost eight years. There are 24 studies that show that it works, dating back almost 20 years, and doesn't happen.
Another good example is giving cortisone to a young mother who is in premature labor. Unfortunately there's not much that you can do to stop a women in premature labor, but if you give her a whole $6 worth of cortisone, her baby has a 50 percent lower chance of needing a ventilator or breathing machine. Her baby will have a 50 percent lower chance of having a stroke. Her baby has a 40 percent better chance of living. And yet we found that it was -- we did surveys, in our health plans only about 16 percent of doctors were giving that drug to women in premature labor. The National Institute of health found the same thing. And we've jointly been working together on a project with several physicians and the agency of Health Care Policy and Research, to raise that.
In that particular case, after we informed our obstetricians about, this is the way -- this is the best standard of care, we said to them, lets give you six months to improve this. And at the end of six months, we will impose our medical necessity clause saying; you doctor, are not going to be paid. They're not allowing our contracts to bill the member. You aren't going to be paid if you don't do what is really a good standard of care. We never had to hold payment on a single physician. We had to, instead, get the education process there, with a strong incentive on the other end, to make them move. And there's a couple of examples of that how commonly practiced standards in the community today, don't match what's really best for the patient. It takes too long for physicians, including me, by the way, when I was in practice, to pick up those standards and to make them part of their common everyday practice. SEN. JEFFORDS: Dr. Meyers, how would a statutory definition of medical necessity based on generally accepted principles of professional medical practice impact the design of Fords medical benefit option?
MR. MEYERS: It probably wouldn't, at least initially impact the design of what we provide. We are very comfortable with our approach. We worry about what would happen to others. But, we're certainly -- we have to be responsive to the specifics, of what would be written. But, we feel, in general, that we are doing the right thing, that we would continue to do the right thing. We work in conjunction with our major union in the United States, United Auto Workers, to understand what they're preferences are, what the company's preferences are and we -- and I guess I mentioned UAW in the -- (laughter) -- and the amplification goes up. I would suggest that we'd have to pay very close attention to the specifics, but I wouldn't see any immediate or significant change in what we do today.
SEN. JEFFORDS: Dr. Corlin, you state in your testimony that health plans that quote, "Determine medical necessity primarily in terms of financial considerations", end quote. In situations where the physician accepts the financial risk for the patient's care, he or she may have a similar incentive to determine medical necessity in terms of financial consideration. Do you have a comment?
MR. CORLIN: I think you're absolutely correct. And what we rely upon is several things. One is the sense of professionalism; to see to it that we always keep what is in the patient's best interest first. I can talk about this, Senator, from my own personal experience. I practice in a group of gastroenterologists. The largest single contract we have is a capitated (?) contract, where by we get some many dollars, per patient, per month, regardless of what services we provide under that contract. That one single contract represents about a quarter of all of the annual income to our office. So, it's a very substantial contract in its size.
And our request that was put into the contract, was the fact that if the unit service delivered on a number of procedures, per thousand patients, per month, varies by more than 20 percent up or down, from what it did previously when we were under fee for service. That triggers an automatic review. And that's our design to see to it that our concerns about finances don't impact on the patient's quality. What our concerns are, is not to say insurance companies are always bad physicians or always good. Our concerns are to see to it that quality concerns are put in, that patient needs are kept first, and that appropriate both, triggers for review; and we need to get out of the mentality of a review implies something bad, it's just a review for whatever reason. Both a trigger for review, and guarantee language is put in to see to it that what the patients needs are -- very tremendous -- which varies tremendously, can be kept foremost.
And this goes across what a lot of us have been saying, what Dr. Wennberg commented on earlier, about involving the patient in medical necessity. One of the things I treat is patient's with bleeding ulcers. Somebody is hemorrhaging out massively from a bleeding ulcer; the medical necessity is transfusions, among other things. If that patient is a seventh day Adventist, I need to take into account, that patient's wants and demands in tempering how I'm going to apply the medical necessity. That doesn't change the medical necessity, but it clearly may change what I do to the patient.
SEN. JEFFORDS: Senator Kennedy?
SEN. KENNEDY: Let me ask Dr. Newcomer or Dr. Meyers. If we said best medical practice instead of generally accepted principles of medical practice, would you still oppose it?
MR. NEWCOMER: Senator, I think the term is still vague enough, and I would be happy to volunteer some time with your staff to try and work out the right terminology, but I think we need to set a very objective standard. Standards that say there's lots of good evidence here. And the problem that we have with ambiguous terms is that in the rare instances when we do have to go to court, the judge is as confused as we are in trying to interpret that language. So, I do not have precise language today, but would be happy to volunteer.
SEN. KENNEDY: Dr. Meyers?
MR. MEYERS: The best medical practice is what we are shooting for today, what we strive for. And the issue is how the interpretation will occur at various different levels, what the employer will interpret, what the lawyers will interpret, what the patient will interpret. And for that reason, we're not certain, putting it in statute, is going to solve the real underlying problem.
SEN. KENNEDY: What you need, as we've heard here, you need the criteria out there. I mean, what we're talking about -- I mean, we have, you know, in most of our supreme -- Bill of Rights, are in generalities, and they are enforced in terms of what the particular facts are. You know, reasonableness in terms of it. We're talking about, in this situation, is very, very clear what we're looking for, the best practices and the best science. Now, maybe there's ways of defining that without indicating that, or incorporating, the best science and the best research and the best judgement of the doctor after the careful information of the patient. Now, if there's a way of expressing that, then we ought to get the wordsmiths in here to do it, because that's what we want to do. That's what we understand is the position that is by doctors and professionals, the way that they've been attempting to practice over a period of time.
If we haven't got the right words, we need to get those. We need to get those. We need people, if they agree. Now, if they don't agree with that, then that's another matter. That's another matter. But, if they -- people, if that's what we agree with on that, if you agree, Newcomer agrees, Dr. Corlin agrees then we ought to -- then we're well down the road in terms of trying to get resolving this -- that kind of issue.
MR. MEYERS: Well, Senator, I'm not going to disagree with your assessment of the need. I will simply respond by saying, as I testified earlier. I don't think there's a definition that you'll right that will change what we want to do, and will change the intent of what we're doing, and will change the ultimate decisions that my physicians, and I make on a daily basis. We are, today, looking to perform the best as we can for our patients and we will continue to do so.
SEN. KENNEDY: Yeah, well, that's what -- we're hopeful that we can use that as the criteria. That every insurance policy will give you the opportunity to do that. That's what we want to try and do, just what you stated. Say, that's the way it ought to be, and that the decisions ought to be done the way you've described it using your best training, your professionalism and the best information that you've got. It may not be the -- you know, there may be somebody else that got something else or another way. But that's about as good as we can do, I think, I expect. I mean, that's the way it's been. That's the way it's going to be. But that's a lot different than opening a door where the insurance companies can draft what they are going to use as the measurement in terms of the range of services that are going to be provided on it. And that's the dilemma. It seems to me that we ought to be able to get language.
Do you have problems with that, Dr. Newcomer?
MR. NEWCOMER: No, I think that language can be destructed that will get there. But, it would take a good lengthy debate to do it.
SEN. KENNEDY: Well, obviously if you get to the language -- if you can agree with us that we want to get, you know, the best judgement of the physicians that have gone through professional training and past their boards, continuing, they're going to have different kinds of assessment. But, in terms of that individual, it's going to have an informed consent, and they're going to use the best information, the best science and make the medical judgement on this. That's what we're interested in. And that ought to be the criteria. That ought to be the criteria. We don't have a problem with that, do we?
SEN. KENNEDY: And what we're trying to do is get the language that reflects that. And if this language isn't right, then we ought to try and see, if we all agree -- if we agree with that assumption, to see what can be done to try and sort of get it. And we've asked you, if you do have changes, or alterations, we'd hope that we'd be able to get those from you. MR. MEYERS: I would hope that, senators, that that language would go beyond what we talked about earlier with that patient preference issue with Dr. Wennberg. I think the real tragedy here is that there are 44 million patients that don't yet have the opportunity to participate in this debate.
SEN. KENNEDY: You and I can sit down and talk about that anther time. (Laughing) -- You know, I'm all for it.
MR. MEYERS: The two of you and the both of us -- the private sector in the best position to work together on that question and I think that's where we really need to focus our efforts.
SEN. JEFFORDS: Well, I want to thank you all. All the witnesses we've had have been extremely interesting. Whether we've solved all the problems, I doubt. But certainly we know a lot more and we'll have to grapple with the drafting. And I appreciate your willingness, as I assure that is, if we have further questions of you we can give you a call on the phone or write them in writing to you, and you will, I'm sure, try to and help us.
Thank you very, very much.
PANELISTS: Thank you.

LOAD-DATE: March 4, 1999

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