25 ALAN MUNEY, M.D.; Sworn

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1 DR. ALAN MUNEY, CHIEF MEDICAL OFFICER,

2 OXFORD HEALTH PLANS: Thank you, Assemblyman

3 Gottfried and the panel.

4 First, I'd like to recognize what Ms.

5 O'Connell said, which is we certainly do have a lot

6 to learn about Lyme disease. That having been said,

7 we have a lot to learn about many of the diseases

8 that we deal in day in and day out. And what we base

9 current treatment on is evidence-based medicine. And

10 if you look at just the course of Lyme disease, you

11 know, it's been almost 25 years since the curious

12 illness was noted in Connecticut, and we didn't know

13 anything about it. We now know what causes it. We

14 know how it's transferred. We know what the

15 treatment should be. We know what diagnosis can

16 be -- what tests can be used for diagnoses. And as

17 with everything in medicine, there's going to be some

18 controversy around treatment and even diagnosis.

19 This exists whether it's in illnesses such as cancer,

20 congestive heart failure, and the list goes on and

21 on.

22 But what I'm here to talk about is the

23 principles that have guided me not only in my views

24 as Chief Medical Officer at Oxford, but also in my 18

25 years of practice as a pediatrician and a pediatric

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1 hospitalist, and that is that: As frustrating as it

2 may be at times, we're only as good as the science

3 that we have produced in medicine and the treatments

4 that have come from that science.

5 Without going over a lot of what Dr.

6 Liegner did, we certainly know the organism. You've

7 heard the issues around the diagnoses. And in terms

8 of the tests, what we see at the health plan is that

9 there still is some confusion about the disease. And

10 that confusion may come from -- everything from some

11 doctors not being well-read on the issues to just

12 normal professional disagreements about how to treat

13 an illness. But we do see that practitioners

14 diagnose Lyme disease in cases where they have not

15 included other diagnostic possibilities. There's

16 misinterpretation of marginal false-positive tests.

17 Again, you've heard some of the difficulties with the

18 tests.

19 But to come back to evidence-based

20 medicine and who puts out guidelines, I think we sit

21 here and it's easy to say we have disagreements with

22 certain organizations. But the Centers for Disease

23 Control, the FDA, the American Academy of Family

24 Practice, the American -- rather, the Infectious

25 Disease Society of America - of which I might add

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1 that Patricia Coyle is a member of - all have come

2 out with diagnostic and treatment guidelines based

3 upon the current status of science. So, let me dwell

4 a little bit on that, in terms of the medical

5 protocols that we use at Oxford.

6 We do use the medical protocols that

7 are based on these practice guidelines that are put

8 out after very rigorous scientific research,

9 controlled studies on large number of patients. That

10 is why it's a little bit concerning for me to sit

11 here and listen to a lot of very passionate and,

12 understandably, well-meaning approaches to an illness

13 that are, in the end, somewhat anecdotal and not put

14 to the rigorous tests of scientific evidence like you

15 do find in journals that are peer-reviewed by

16 academicians, such as the New_England_Journal_of_

___ _______ _______ __

17 Medicine. Let me show you the process, though, and

________

18 talk a little bit about what New York State already

19 has in place to deal with controversial areas -- not

20 just in Lyme disease, by the way, but any new

21 technologies that come up that may have guidelines

22 around them that, again, medicine puts into the best

23 of their current knowledge.

24 Since 1999 - and this includes, by the

25 way, New York, Connecticut and New Jersey for us -

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1 we've received almost 500 requests for intravenous

2 antibiotic therapy for late-stage Lyme. Every

3 request is reviewed by board certified

4 rheumatologists, infectious disease specialists, and

5 we approved 73 percent. So, the vast majority go

6 through approved. Of the 57 cases that were denied

7 for various reasons -- and those reasons run the

8 gamut, frankly, from -- anywhere from antibiotics

9 that want to be used that have no proven value to

10 treatment regimens that skip weekends and things like

11 that. Of the 57 cases, we had only 12 percent, or

12 only seven of them were overturned, and this included

13 going to New York State External Review as well as in

14 Connecticut.

15 Now, frankly, given a disease that is

16 obviously very controversial, an uphold rate of 88

17 percent, I think, is rather phenomenal and I think it

18 speaks to the process that is used. And, again, we

19 endorse very highly the treatment guidelines put out

20 by those organizations. We endorse very highly the

21 process of New York State's External Review, because

22 I think it works definitely to the betterment of the

23 citizens of New York State. And in that process the

24 specialists in Lyme disease in those board certified

25 areas are used by the External Review agents that

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1 look at the tests. So, I think overall it's a very

2 good process and that it's working.

3 I would also like to bring up that

4 inappropriate use of antibiotics -- we all have heard

5 the problems. There is either resistance that

6 develops in the germs or that patients develop

7 complications. And I have to tell you, even among

8 the cases that were approved, we still had a ten

9 percent complication rate, in terms of complications

10 from antibiotic use, everywhere from liver problems

11 to low blood counts. And that, again, was in things

12 we had approved. So, I think it behooves us to be

13 very prudent, to limit the risk of long-term, unended

14 antibiotics, particularly when you at least take the

15 possibility into account that you may do more harm

16 than good, ultimately.

17 But, in the end, we're all sitting here

18 because we want all patients to get all the medicine

19 that they need and none that they shouldn't. That is

20 high-quality medicine. That is the tenet of the

21 evidenced-based medicine that, as a doctor -- and

22 that as all of the doctors that belong to all of

23 these professional societies -- who, by the way,

24 write these guidelines based on the evidence, who

25 subscribe to -- we're only as good in medicine as

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1 current thought.

2 Now, that's not to say that physicians

3 can't have important theories about how to treat;

4 that there aren't both physician anecdotes about what

5 happened to their patients, as well as patient

6 anecdotes about what happened to them when they were

7 treated. But, in the end, unless these theories and

8 anecdotes are tested in a controlled, scientifically

9 rigorous fashion, we would not have progressed today

10 to the point we are in medicine, with the wonderful

11 technologies and treatments that they have, because

12 they have to be peer-reviewed and they have to, after

13 peer review in reputable journals, be put into

14 widespread practice. And that is the frustration

15 here, because we have, clearly, persistent symptoms

16 in some people who have been treated with Lyme

17 disease. We have, clearly, doctors that are very

18 passionate about it. But, again, it's not only in

19 Lyme disease. It happens in cancer, it happens in

20 heart disease. But, in the end, we're governed by

21 the science - and reproducible science - that studies

22 lend themselves to be.

23 Now, I do want to bring up the study

24 that was published early, by the way, because it

25 seems so significant, in the New_England_Journal_of_

___ _______ _______ __

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1 Medicine. And this study tried to deal with the

________

2 issues of what happens with the post-Lyme syndrome,

3 or what's also known as chronic Lyme disease, in both

4 patients who have had a positive test and those

5 patients who have been treated with Lyme previously,

6 with a negative test, trying to recognize that there

7 have been difficulties in terms of the testing.

8 And what happened was these patients

9 were given up to 90 days of antibiotics, which is

10 basically twice the guideline, in order to see what

11 happened. And, in fact, the reported symptoms -

12 either better, the same or worse - among these

13 patients were exactly the same when they were treated

14 with more antibiotics or when they were treated with

15 placebo - placebo meaning nothing at all.

16 So, again, this is a peer-review

17 journal. This is the New_England_Journal_of_Medicine

___ _______ _______ __ ________

18 . And very few journals, frankly, have such esteem

19 among doctors that they will cause widespread change

20 of practice. And anecdotal studies, studies that,

21 again, are reported on single cases, need to be put

22 to this rigorous test in terms of large numbers of

23 patients. It is only then that science progresses.

24 And in terms of what we do at the

25 health plan, we do try to use evidence-based medicine

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1 and guidelines. And regarding the cost, when new

2 technologies come out, of course they cost more.

3 But, in the end, it's a decision that society is

4 willing to pay for; it is ultimately reflected in the

5 premiums. So, in terms of the long run, we have, you

6 know, no predilection one way or the other to go

7 except with what the evidence says, and the cost is

8 what it is over the long run.

9 So, again, you know, there's got to be

10 sympathy for the chronic symptoms as well as for the

11 doctors who are passionate about treating them. I do

12 think that the process that we have in place, again,

13 in New York State works very well. If something

14 falls out of the guidelines -- and, by the way,

15 guidelines are just that. They're just guide posts

16 along the way. They should not be black and white.

17 And, in fact, every case that doesn't fit the

18 guidelines ends up getting reviewed by experts who

19 look at the individual issues in the case, the

20 difficulties that have happened along the way, and

21 then render an opinion. I don't think, frankly,

22 whether it's in terms of medicine in general with

23 guidelines or whether it's in terms of the external

24 review process that's already in place in New York

25 State, that we can ask any better of the people that

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1 are trying to, as specialists, deal with those

2 issues.

3 So, in the end, we have also had our

4 problems with patients and with doctors. I've heard

5 a lot about the OPMC today. We, frankly, had a

6 patient who complained to us after she had

7 complications from long-term intramuscular injections

8 of penicillin. We actually did, through our quality

9 management committees, which are made up of

10 practicing physicians as well as specialists in the

11 appropriate areas, in this case, Lyme, look at

12 another ten cases and found - and this their words -

13 "gross over-diagnosis, treatment beyond guidelines,"

14 and in their view it was a problem. And I reiterate

15 this only because, again, in medicine, we're only as

16 good as the current evidence and guidelines.

17 Anecdotes, issues that come up need to be put to the

18 test. And, again, the problem with why we're so --

19 we're sitting here today is because there's so much

20 passion around illnesses for which there is no

21 seeming relief of symptoms, even after the best

22 evidence is used.

23 And so where will we be in 25 years

24 from now with Lyme disease? It's hard to say because

25 we've come so far in the first 25 years. In the end,

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1 frankly, any therapeutic -- it still remains in the

2 hands of experienced physicians that evidence-based

3 guidelines and national standards of care. Where

4 there are conflicts between how a physician wants to

5 treat a patient and what the guidelines say, the New

6 York External Review Program already in place should

7 be used as it was intended: To have experts in the

8 field review the cases according to the evidence,

9 according to the guidelines. And until all

10 physicians use evidence to govern how they practice,

11 whether, again, it's in Lyme disease or other

12 diseases, patients will continue to get treatments

13 that they shouldn't and not get the treatment that

14 they should. We want evidence to really govern what

15 appropriate treatment is. Allowing untested theories

16 and individual physician anecdotes to dictate

17 allowable treatment regimens, in general, do a

18 disservice, frankly, to why we're here: Again, to

19 ensure that the high-quality based-medicine be

20 delivered to the patients of this state.

21 Thank you.

22 MR. GOTTFRIED: Thank you. Could you

23 just review for me, or state for me again -- you

24 referred in the New York, New Jersey, Connecticut

25 region --

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1 DR. MUNEY: Yes.

2 MR. GOTTFRIED: -- to 550 requests for

3 treatment, 73 percent of which were approved

4 initially. The treatment involved, again, was --?

5 DR. MUNEY: The treatment involved was

6 requests for long-term antibiotics, which we actually

7 allow even beyond the guidelines, up to six weeks --

8 which happened to coincide with the Connecticut

9 legislation. And that's actually -- what Connecticut

10 has chosen to do was -- and I hope it was clear when

11 Mr. Blumenthal was speaking -- was they were using

12 the available evidence to dictate the treatment.

13 Now, where board certified specialists, again, in

14 those areas that normally deal with Lyme disease have

15 said that you should go beyond that length of

16 treatment, we have used external review to review it.

17 And obviously we abide by the decision.

18 MR. GOTTFRIED: So, Oxford itself,

19 other than going through external review, would not

20 approve some -- would not approve antibiotic

21 treatment longer than six weeks?

22 DR. MUNEY: What Oxford would do is

23 approve antibiotic treatment intravenously; that is,

24 up to six weeks' treatment -- actually, both oral and

25 intravenous combined unless, again, you know,

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1 specialists recommended in specific instances after

2 they reviewed the case.

3 MR. GOTTFRIED: Meaning your

4 specialists or the patient's --?

5 DR. MUNEY: No, these are independent

6 specialists; in other words, the infectious disease

7 specialists. These are not Oxford physicians. In

8 other words, they're independent specialists we send

9 these cases out to.

10 MR. GOTTFRIED: But the company's

11 policy would be that if there was a request from a

12 patient, based on a treatment recommendation by the

13 patient's board certified rheumatologist, what have

14 you, for longer antibiotic treatment than the initial

15 six weeks, Oxford's policy would be to deny that and

16 to provide it only if your judgment were -- the

17 company's judgment were overturned either by internal

18 review or by external review?

19 DR. MUNEY: That is correct, because

20 the current practice guidelines - again, the ones put

21 out, as I said, by the Infectious Disease Society of

22 America, CDC, the American College of Physicians -

23 all state that. So --.

24 MR. GOTTFRIED: Those guidelines state

25 that longer than six weeks is never appropriate?

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1 DR. MUNEY: The current guidelines that

2 are in place will say, for example, for late Lyme

3 disease, that there's -- you get a month's worth of

4 oral therapy or a month's worth of parenteral

5 therapy. If you have a reoccurrence, you actually

6 can get more therapy, another month of either, as

7 well. So, these are the guidelines that are in

8 place.

9 And so I think the point I'm trying to

10 make is that if the -- again, these are written by

11 physicians. We don't -- and if there's any

12 misconception about this -- I think it's very

13 important. Health plans do not write their own

14 guidelines for treatment of illnesses like this. We

15 incorporate the guidelines that are out there, in

16 terms of the evidence-based medicine, and then we

17 look at things to see if they satisfy those

18 guidelines. And, again, this is not different for

19 Lyme disease. It is not being singled out. It's the

20 same thing whether it's a new treatment in another

21 area or whether it's established treatments that need

22 to be reviewed appropriately against guidelines, no

23 matter what the illness.

24 MR. GOTTFRIED: Is it your

25 understanding that -- just to turn to the state of

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1 the peer-reviewed literature and --

2 DR. MUNEY: Uh-huh.

3 MR. GOTTFRIED: -- of course, not all

4 peered-reviewed literature is about double-blinded

5 clinical trials. Is it your understanding that

6 evidence-based medicine would conclude at this stage,

7 that longer term treatment than you would -- that you

8 cover under your guidelines has been demonstrated to

9 be wrong, or is it that it has not been demonstrated

10 to be appropriate? In other words, is it something

11 where we know the answer and the answer is no, or is

12 it something where you believe we don't yet know the

13 answer?

14 DR. MUNEY: Well, the current evidence,

15 again, as in the recently published article in the

16 New England Journal, would state that the current

17 evidence -- now, whether it's right in 25 years or

18 wrong in five years -- again, medicine is dynamic.

19 Studies are done all the time and guidelines changed

20 to be appropriate for the practice. And so at the

21 current time, in the current state of thinking with

22 the current literature that's been published, again,

23 by reputable peer-reviewed journals such as New

24 England Journal -- and they're very -- again, few

25 journals that will change the widespread practice of

95

1 medicine; that's one of them. At this current time,

2 the thinking does not support that.

3 MR. GOTTFRIED: Now, the New England

4 Journal study, if we're talking about the one that

5 came out, I guess, spring of this year --

6 DR. MUNEY: I'm talking about the

7 Klempner study.

8 MR. GOTTFRIED: -- was fairly limited

9 in terms of number of patients and duration. Was

10 Oxford's practice different before that study came

11 out?

12 DR. MUNEY: Well, first of all, let me

13 clarify it. I don't know what you mean by "limited"

14 in terms of duration and the number of patients.

15 What the experts felt, that were looking at the

16 study, was that they thought it was so important that

17 there did not seem to be any significant difference

18 in those two sets of patients that they actually

19 terminated the study early. And at the time they

20 terminated it, it had a hundred some-odd patients in

21 the study. And what they looked at was the

22 guidelines -- they actually doubled the guidelines

23 for the current thinking, which was up to 90 days.

24 So, in terms of what Oxford -- then

25 Oxford was at the current published guidelines --

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1 which, as a result of that study, by the way, people

2 reaffirmed that that's the current state, that's

3 where it should be right now.

4 MR. GOTTFRIED: Meaning the six weeks?

5 DR. MUNEY: Meaning up to six weeks of

6 antibiotics.

7 MR. GOTTFRIED: Okay. Because that's

8 about half of 90 days.

9 DR. MUNEY: That's half of what the

10 study -- that's right, that's half of what the study

11 had looked at. The study actually gave antibiotics

12 for up to 90 days, both, again, in placebo - meaning

13 nothing - oral and IV, and used both patients who

14 didn't have the diagnosis of Lyme - they tested

15 negative but had the persistent symptoms compatible

16 with what we call chronic Lyme disease or post-Lyme

17 syndrome - and compared it to the patients who did

18 have positive. So, it kind of tried to take both of

19 those sets of patients in, and did not show any

20 difference. The same number of people said they got

21 better, stayed the same or got worse.

22 So, it's this type of study that needs

23 to be done, in terms of rounding up other treatment

24 regimens and stop them from being theories and

25 anecdotes, and see if they're actually viable for

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1 practice.

2 MR. GOTTFRIED: Was there an evidence

3 basis before this New England Journal study for the

4 guidelines being used by Oxford and several other

5 companies?

6 DR. MUNEY: Well, the guidelines are

7 always evidenced-based. I can't recount without

8 going back and looking, you know, historically the

9 article that came out. But when guidelines get

10 published, again, by these societies, they do

11 incorporate the length of -- or duration, as it's

12 called -- of the treatment and monitor what happened

13 with those patients. That's how the guidelines come

14 out.

15 MR. GOTTFRIED: Because from what

16 little I know about such things, the -- I mean, my

17 sense of New England Journal study was that it was a

18 relatively small study and only one study. And

19 practice guidelines -- and if you talk about an

20 evidence practice guideline, I would think you would

21 want that to be based on an analysis of considerably

22 more than one study.

23 DR. MUNEY: Well, I think if you look,

24 again, across the spectrum, different illnesses that

25 have guidelines, you will find defining studies that

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1 have a statistically valid number of patients -- and,

2 again, that's what the peer review process looks at.

3 And so it assesses, essentially, or audits the

4 process, how the patients were enrolled, whether it

5 was a statistically valid number of what they were

6 saying happened to be correct in their conclusions

7 compared to the evidence that they documented during

8 the study. So, you'll find varying numbers of

9 patients in different studies that end up being --

10 determined to be evidence of a change in treatment

11 plan that's being called for, for that particular

12 illness, and then ultimately published as a

13 guideline.

14 MR. GOTTFRIED: I would appreciate it

15 if you could assemble what Oxford -- I mean, I assume

16 you can do this -- could assemble such a collection

17 of articles --

18 DR. MUNEY: Yes, we could.

19 MR. GOTTFRIED: -- on this question and

20 either send us the articles or the references?

21 DR. MUNEY: Yes, I would be happy to

22 put together a bibliography for you that kind of

23 traces it over time.

24 MR. GOTTFRIED: Okay. And I guess -- I

25 think my last question would be: What has been

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1 Oxford's experience with the Connecticut law?

2 DR. MUNEY: Our experience with

3 Connecticut law has generally been favorable from the

4 point of view that the Connecticut law is

5 evidence-based. It does allow those specialists who

6 have specific competence in Lyme disease as

7 outlined - as you heard, neurologists, infectious

8 diseases, et cetera - to override, if you will, a

9 guideline based on individual patient need. Now, the

10 same, of course, occurs currently in the New York

11 State External Review Law, in the sense that the

12 specialists who review the case have that latitude to

13 override it. So, from that point of view, the actual

14 way it functions has not been significantly different

15 in our experience.

16 MR. GOTTFRIED: Well, the difference,

17 as I understand it, between the Connecticut law and

18 the New York law is that in the New York system -- I

19 mean, there are -- there can be three or four board

20 certified specialists: One is the patient's treating

21 physician, the other is the company's own reviewer, a

22 third would be the internal review person that the

23 company may turn to, and then the fourth would be the

24 people at the external review stage. They could all

25 be board certified specialists in infectious diseases

100

1 and all four could come to a different conclusion.

2 The significance in the Connecticut law is that it is

3 the first of those that I mentioned, namely, the

4 patient's treating board certified infectious disease

5 specialist, who would be the governing person there.

6 And that's significantly different from the system in

7 New York.

8 DR. MUNEY: Well, the system -- in that

9 case, that would be different in the sense if it was

10 a board certified infectious disease specialist

11 who -- and if I had to choose one problem --

12 theoretic problem, that is -- as I said, I don't

13 think our experience has had any difficulty -- but a

14 theoretic problem could be if, even though the doctor

15 was board certified in those diseases that they --

16 infectious disease, et cetera, that they were not

17 following the current evidence, then theoretically it

18 doesn't -- you know, it matter what their board

19 certification is. I think the intent of the law was

20 to allow those physicians with that

21 subspecialization, who theoretically have that

22 knowledge, are current with the current thinking of

23 how to treat that disease, to have the latitude to do

24 what they would like. So, in general, it works.

25 When the issue would come through

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1 Connecticut, the practice -- in fact, I would have to

2 check, Assemblyman, to see whether or not, actually,

3 it would go to a second board certified infectious

4 disease specialist. I'm not aware that it would at

5 the current time. In New York, the difference would

6 be that if it went to external review - which,

7 frankly, as a second opinion program for patients is

8 not a bad idea - it would definitely have to go to,

9 you know, a specialist within external review. That

10 may be infectious disease, it may be rheumatology,

11 for example.

12 MR. GOTTFRIED: Okay. Thank you.

13 DR. MUNEY: Sure.

14 MR. GOTTFRIED: Other questions?

15 MS. O'CONNELL: Yeah. Thank you,

16 Doctor, for your testimony.

17 I'm just a little fuzzy on some of the

18 information you gave us earlier. You said you had --

19 in terms of approval for antibiotic therapy you had

20 500 requests. And that came from how many patients?

21 Maybe I missed it. I'm sorry.

22 DR. MUNEY: Well, we had 489 --

23 MS. O'CONNELL: Okay.

24 DR. MUNEY: -- requests, right, for IV

25 therapy across the Tri-State. I assume -- I would

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1 have to go -- I assume those are on the same

2 patients, but I would have to go back and look.

3 MS. O'CONNELL: You mean 489 different

4 patients or 489 requests?

5 DR. MUNEY: That's 489 requests. It's

6 obviously possible some of them could be on the same

7 patients. I would to have to go back and get that

8 specific data.

9 MS. O'CONNELL: Yeah, that's what I'm

10 interested in.

11 DR. MUNEY: We can get that.

12 MS. O'CONNELL: That would be great.

13 DR. MUNEY: Sure.

14 MS. O'CONNELL: Because I would like to

15 see whether or not the requests you're receiving come

16 from, you know, 25 patients who made 500 requests for

17 antibiotic --

18 DR. MUNEY: Sure.

19 MS. O'CONNELL: -- therapy and over

20 what course -- what period of time these requests

21 were made. Because maybe -- you know, maybe what

22 you're telling us is that we have a small pool of

23 people asking for numerous cycles of antibiotics, or

24 we have -- you know. And you understand my question?

25 DR. MUNEY: Absolutely.

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1 MS. O'CONNELL: I would really love to

2 see that hard data.

3 DR. MUNEY: I can tell you we have a

4 definitely smaller number of physicians that are

5 making the majority of the requests.

6 MS. O'CONNELL: I'm sorry, you have a

7 small --?

8 DR. MUNEY: We have a smaller number of

9 physicians that are making the majority of the

10 requests. But I would have to go back and get you

11 the numbers on both the numbers of physicians and how

12 many they are responsible for each, as well as how

13 many patients --.

14 MS. O'CONNELL: Why do you think you

15 have a smaller -- is that a smaller number of

16 physicians making these requests? That number is

17 diminishing over, say, a period of years; two years,

18 three years? Can you give me some kind of context

19 whether or not --?

20 DR. MUNEY: I couldn't.

21 MS. O'CONNELL: You couldn't. Okay.

22 DR. MUNEY: I couldn't. And, in fact,

23 I would expect it, if anything, to expand, given the

24 fact that, you know, Lyme disease is -- first of all,

25 it's the most reported infectious disease among --

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1 you know, for -- caused by insects, spiders. Because

2 there's over 16,000 -- those are just the reported

3 cases per year. So, you know, we're dealing with,

4 you know, a very large epidemic, as, you know, has

5 been said more eloquently today than I have.

6 MS. O'CONNELL: Because my concern is

7 that I would like to see what Oxford's experience has

8 been regarding the chronic patient who may require

9 multiple courses of treatment over a period of time.

10 You know, I think that might be helpful to us to sort

11 of get an idea of what your experiences are. And

12 that would be helpful in evaluating where we might be

13 going with this --

14 DR. MUNEY: Right.

15 MS. O'CONNELL: -- and that would be

16 very good.

17 I have no other questions right now.

18 Thank you, Doctor.

19 DR. MUNEY: Thank you.

20 DR. MILLER: Thank you.

21 Just let me begin with a comment so we

22 can clarify something, because you kept referring to

23 "experts," and I think it's important that we clarify

24 the definition of "expert" by looking at its root.

25 "Ex" is a former and a "spurt" is a drip under

105

1 pressure. And so we seem to be getting a lot of

2 advice of former drips under pressure, but I'm not

3 sure that that's necessarily scientific either.

4 You talked about evidence-based

5 medicine, and it seems to me that we have two pools

6 of evidence. We have one pool of evidence that, as

7 an example, says that it's very difficult to get,

8 under the current situation, an easy blood test to

9 verify the existence of Lyme disease. That's one set

10 of evidence. And then you have another set of

11 evidence that says that you have to have a bull's-eye

12 rash and you have to have a blood test and -- you

13 know, the CDC says this.

14 Did you ever have a case where your

15 company chose the body of evidence that would cause

16 you to spend more money rather than less money? In

17 other words, did you ever decide that, well, gee,

18 there's evidence A and there's evidence B, let's go

19 with evidence B. It will cost it twice as much, but

20 I like that set of evidence better. Do have any

21 entity that you could refer to where you -- because

22 there evidently is still two pools of evidence here.

23 Do you have any cases like that?

24 DR. MUNEY: Well, with all due respect,

25 Dr. Miller, evidence-based medicine -- and to use the

106

1 experts that you elucidate, the experts -- my

2 definition of "experts" are those that are grounded

3 in scientific principle, what experiments mean, what

4 the evidence within those experiments would allow to

5 become adopted as treatment. They are not flippant.

6 DR. MILLER: Flippant.

7 DR. MUNEY: It is -- and neither are

8 health plans. And, again, with all due respect, I

9 think it's easy to sit up there and have a dialogue

10 in which it's made to look like insurance plans are

11 sitting here and trying to decide on smaller bodies

12 of evidence rather than those that are published by

13 experts, professional societies, and everyone that I

14 name. That's not the case.

15 DR. MILLER: Okay. So, I could take it

16 that the answer is you've never selected a body of

17 evidence where you would have had to pay more? Do

18 you remember the case in California? It had to do

19 with bone marrow transplants, where the insurance

20 company kept insisting that it was so experimental

21 that we shouldn't pay for it. I think it cost them

22 $123 million to make that prudent decision. And,

23 yet, now bone marrow transplants seem to be a

24 relatively --.

25 DR. MUNEY: Well, actually, the case,

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1 Dr. Miller -- if you want to get specific, it was the

2 Nellie Fox case back in the '80s. It was Health Net.

3 They denied a bone marrow transplant based on

4 absolutely the correct evidence according to all the

5 experts that testified at the trial. They were

6 overturned because Nellie Fox happened to not be an

7 employee of Health Net, whereas the last one they

8 approved was an employee of Health Net, that had

9 different medical criteria, different clinical

10 course, and that the experts agreed should not have

11 had it. So, it's a bad example.

12 DR. MILLER: Well, we have our own

13 opinions based on the evidence.

14 DR. MUNEY: And you can look it up.

15 DR. MILLER: Let me ask you this.

16 You're a pediatrician. Do you remember a time in our

17 history when premature babies were treated by being

18 put into oxygen-rich environments?

19 DR. MUNEY: Absolutely.

20 DR. MILLER: And did most of the

21 pediatricians that provided that treatment end up

22 getting sued when these people reached their majority

23 and had lost their vision?

24 DR. MUNEY: The problem with that --

25 again, you choose a case in which neonates received

108

1 high-dose oxygen therapy, trying to save their lives

2 with -- by passionate physicians who knew not else

3 what to do. There was no other treatment at the

4 time. They developed retrolental fibroplasia, which

5 interfered with their vision, and most of them did go

6 blind. And it was out of the passion to try to treat

7 them, which, again, was based at the time on

8 anecdotal evidence -- correct passion, anecdotal

9 evidence, and ended up hurting them. And that's

10 exactly what I'm trying to say we should not allow to

11 happen here.

12 DR. MILLER: So, if you have someone --

13 and we used to hear that, you know, 28 days of

14 antibiotic treatment and you're cured; right? I

15 mean, we had Detweiler out at Stony Brook said 28

16 days of treatment and now you're cured. Well, how do

17 you explain a situation where you've had your 28 days

18 of treatment and now you're cured, and you have no

19 additional invasion by a microorganism and then

20 suddenly you begin to show the symptoms again? So,

21 you haven't been reinfected, but now you're not

22 cured. So, there we had expert opinion. It happened

23 to be what was widely believed at one point not that

24 long ago. And now the person is showing symptoms

25 again - not new infection, the same old infection.

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1 Obviously, it wasn't cured. And this can go on and

2 on.

3 How do you determine the exact length

4 of time when someone is cured based on the

5 evidence-based evidence you like, from the experts

6 that you like, if, in fact, they keep getting sick?

7 And, of course, if you're going to give me the answer

8 that, well, these people don't get any better, and

9 we've proved that with the placebos up in the New_

___

10 England_Journal_of_Medicine -- and I think that the

_______ _______ __ ________

11 people in the audience here would love to have a

12 bottle of those placebos so that they don't have to

13 take the antibiotics anymore, and they'll feel better

14 and cured. But, I mean, how do you have people

15 without additional infection keep coming up with the

16 same types of symptoms and have people -- is it that

17 each week you can change your evidence and say, well,

18 we thought they were cured, now they're not cured, so

19 we're still right. But now they're cured, well, I

20 guess they're not cured, but we're still right

21 because we're using the same group of evidence. I

22 mean, that's what we're seeing here. We have people

23 who, based on the evidence that you're referring to,

24 have been cured -- it's like the person who can stop

25 smoking every night when they go to sleep, they just

110

1 start again every morning when they wake up. I mean,

2 have they really stopped smoking?

3 I mean, how do you explain this

4 continuation if, in fact, we're referring to this

5 body of evidence that you select which says that they

6 keep getting cured, but unfortunately the cure just

7 doesn't last?

8 DR. MUNEY: I just want to reiterate,

9 it is not the body of evidence that I select. It's a

10 body of evidence that very well-educated, academic

11 physicians who have been in the field decide to

12 select because it demonstrates the scientific rigor

13 of experiments and studies that are done on these

14 patients.

15 Now, to the extent that there are cases

16 not explained by what has already gone on within

17 those studies and the evidence presented, again, that

18 is no different in Lyme disease than it is in any

19 other field of medicine. But to take the individual

20 cases -- and, again, we can't sit here without the

21 sympathy for what is driving us to be sitting here.

22 We have a chronic illness for which we have the best

23 evidence that we know at the current time. Like any

24 other illness, it may be completely different

25 evidence in 10 or 15 years, but medicine does the

111

1 best that they can at the current time that we live

2 in. And as a dentist who studied -- that clearly

3 should have been part of your education. Anybody

4 who, frankly, practices outside of the evidence on a

5 chronic basis, I think there's an issue.

6 DR. MILLER: Well, let me ask you this.

7 You keep referring to medicine, but you're really not

8 medicine. You're the insurance company that's

9 paying. So, shouldn't we make a differentiation

10 between what medicine says and what the insurance

11 company is willing to pay for? I mean --.

12 DR. MUNEY: No -- I -- no, I think we

13 should stop right there and try to address that.

14 What any insurance company pays for and

15 the decisions what they pay for is based upon the

16 best evidence that there is. We could pay for

17 everything, you know, from, you know, instilling hot

18 ascorbic acid into, you know, festering wounds, if we

19 would like to, but there is no evidence to say that

20 that's the appropriate treatment. If everyone wants

21 insurance companies to cover that, it can be covered.

22 But the premium resulting over time -- which is a

23 decision that, you know, society decides that they

24 may or may not want to pay for. It's just something

25 we have to deal with.

112

1 DR. MILLER: Let me ask you this, then.

2 Would you say that the State of New York and the

3 State of Connecticut violated all reasonable

4 scientific evidence when they decided that insurance

5 companies were wrong for throwing -- or trying to

6 throw women and their babies out of hospitals within

7 24 hours of birth? Was that something that is so

8 overwhelmingly supported by scientific evidence that

9 you can sit there and say we're wrong and, in fact,

10 women and their infant babies should, in fact, be out

11 of the hospital in less than 24 hours?

12 DR. MUNEY: You know, I don't think

13 we're here to discuss that, but the --.

14 DR. MILLER: But we're talking about an

15 insurance company which keeps saying that they're not

16 making decisions based on money, the fact that every

17 decision is always "let's pay the least we can," but

18 they're saying it's based on the overwhelming

19 scientific evidence. And I'm asking you, since that

20 was a determination made by insurance companies and

21 HMOs, is there, in fact, overwhelming scientific

22 evidence that it makes good sense to ask women and

23 their infant children to leave the hospital within 24

24 hours?

25 DR. MUNEY: If you would like me to get

113

1 the evidence for that one way or the other, I would

2 be happy to, Dr. Miller. In fact, I'd also like to

3 point out that these same insurance companies that

4 you are claiming make the decisions on what to pay or

5 what not to pay based upon the least common

6 denominator are the same insurance companies that

7 when you compare them to fee-for-service, in every

8 single measure that you name and any study that you

9 can name, chronically shows that managed care

10 companies actually have provided a high level of

11 care, paid for more tests for things to prevent

12 illness. We have disease management for many of the

13 illnesses that you named, including Lyme disease.

14 Other insurance companies do not do that. If you

15 want to compare on Medicare, in terms of what health

16 plans pay who do managed Medicare compared to what

17 fee-for-service Medicare pays, there's no disease

18 management, there's no customer service, there are no

19 triage nurses on call on night.

20 So, if you want to be, again, very

21 flippant up there and decide that insurance companies

22 only do the least common denominator, I'm happy to

23 discuss it with you after the testimony.

24 MR. GOTTFRIED: Let me ask you one

25 other question, and this will be the last question.

114

1 How many patients that remained ill would it take to

2 convince the insurance companies that there might be

3 a problem? Is it ten patients, is it 100 patients,

4 or is it the 10,000 patients in New York State alone

5 that seem to continue to have these problems? Is

6 it -- I mean, can we look at a scientific body of

7 evidence and say that these 10,000 people would be

8 just as well off taking placebos, or is it that these

9 10,000 people refuse to conform with what some

10 guidelines are? I mean, we can't ask the people

11 conform to the guidelines rather than have the

12 guidelines conform to people -- although I have to

13 remember that when I was taking anatomy, a professor

14 that I had, who happened to be world renowned -- he

15 was an older, quite elderly gentleman, and he didn't

16 hear very well and he didn't speak very well and he

17 the shakes. And he would constantly say, "It doesn't

18 matter what the book says; the body is always right."

19 But we're going to go by the book and not the body,

20 so I guess he was wrong as well.

21 DR. MUNEY: Well, I'll just state

22 again. We're only good in medicine -- and the

23 insurance companies, the guidelines that are

24 published by the professionals within medicine, and

25 that's what we go by.

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1 MR. GOTTFRIED: Nettie?

2 MS. MAYERSOHN: Just a few questions.

3 I think we can all agree that there is no clear test

4 that will tell you whether you have Lyme or you do

5 not have Lyme; that whole area seems to be in debate

6 and in flux. Do we agree on that?

7 DR. MUNEY: I'm not sure we do agree on

8 that. I think that there are --.

9 MS. MAYERSOHN: What I'm saying is, I

10 have read enough the material to get a sense that you

11 can test positive for Lyme and be negative and you

12 can test negative for Lyme --.

13 DR. MUNEY: That's correct. There are

14 false positives and there are false negatives, but I

15 would like to put that into context.

16 Tests are available for many different

17 illnesses. There are false positives and false

18 negatives for many tests in many other illnesses as

19 well. It's, unfortunately, a fact of life that we

20 have to deal with. Trying to base your judgment on

21 clearly on only what the test says may be a problem

22 in certain patients.

23 MS. MAYERSOHN: Right.

24 MR. MUNEY: I think that's what we can

25 all agree on. But we can also agree that when there

116

1 are differences of opinion among clinicians who --

2 again, I don't know a single doctor that comes to

3 work trying to do a bad job -- there are going to be

4 disagreements on how to treat a patient and what

5 things mean. That's why we have the process, as we

6 said, of having specialty review and external review

7 in the state, and I think it serves the purpose very

8 well.

9 MS. MAYERSOHN: Okay. What percentage

10 in Lyme disease, would you say -- where the tests are

11 erroneous, whether -- is it ten percent? Is it two

12 percent? How does that compare with other diseases?

13 DR. MUNEY: I have to apologize. I'm

14 not an infectious disease specialist. I would have

15 to go and look that up for you. If you're asking is

16 it, you know, inordinately high in Lyme disease

17 compared to some things in other diseases, I would

18 have to look. But from having dealt with some of

19 these cases, it doesn't appear to be the case.

20 MS. MAYERSOHN: Where there is no clear

21 answer to our questions, where we don't know, where

22 we test positive and it could be negative, and vice

23 versa, doesn't it mean we have to go to the

24 clinician, to the doctor who's treating the disease,

25 and get a sense of what he's seeing in his practice?

117

1 Doesn't it make sense to talk to a doctor like Dr.

2 Liegner to find out what is happening in his practice

3 that leads him to go on to further treatments beyond

4 the 60 days or the 30 days?

5 DR. MUNEY: I think it's very

6 appropriate to ask the docs like Dr. Liegner, who are

7 as passionate as they are, what and why -- what it is

8 and why it is that they believe that way. But, in

9 the end, it has to be turned into science; it can't

10 be anecdotal.

11 MS. MAYERSOHN: But we're not at the

12 end. We're not at the end.

13 DR. MUNEY: I understand that, but it's

14 the same issue --.

15 MS. MAYERSOHN: When we have a clear

16 test, we will be at the end. Right now we are

17 not --.

18 DR. MUNEY: But it's not just an issue

19 of the test. It is not just an issue of the test. I

20 have to say that in one of the cases that we had,

21 again, that a member complained, there was no

22 positive test. There was the opinion that,

23 regardless of the fact that there was no positive

24 test, this doctor did not even look at other

25 illnesses that may have been causing the problems.

118

1 They used --

2 MS. MAYERSOHN: Do you know that for a

3 fact?

4 DR. MUNEY: It is in the written

5 descriptions from the medical records that were

6 abstracted. And let me just comment. So, in the

7 opinion of the specialists that reviewed these

8 cases -- and if may have just been a problem with

9 this doctor. I mean, there are -- you know, doctors,

10 you know, are in a Bell-shaped curve as far as good

11 and bad, as we all know. This doctor --.

12 MS. MAYERSOHN: I hate to interrupt,

13 but I don't to lose my train --.

14 DR. MUNEY: Sure.

15 MS. MAYERSOHN: When you say in the

16 view of the specialists --

17 DR. MUNEY: Yes.

18 MS. MAYERSOHN: -- who reviewed the

19 case -- whose specialist? Is he the specialist that

20 was referred by the doctor that originally treated,

21 or is there a panel of so-called specialist experts

22 that's set up by the HMO or whatever?

23 DR. MUNEY: No. Well, actually what

24 these were -- were independent specialists in the

25 area of Lyme disease, both rheumatologists as well as

119

1 infectious disease --.

2 MS. MAYERSOHN: But who's the --

3 listen.

4 DR. MUNEY: Yes.

5 MS. MAYERSOHN: I know about

6 independent people, but who selected them? Who put

7 this list together, this panel together?

8 DR. MUNEY: Well, of course, you know,

9 we chose among specialists that are in the area, of

10 course.

11 MS. MAYERSOHN: And they're -- I assume

12 they're paid?

13 DR. MUNEY: Excuse me?

14 MS. MAYERSOHN: Are they paid by the

15 HMO or --?

16 DR. MUNEY: The doctors who review

17 cases are paid for their time. It's no different

18 than anything else -- including external review, I

19 might add. And I think, though -- and it's important

20 we talk this through. I think the --.

21 DR. MILLER: Let me just correct you on

22 that. In New York State now, external view, the

23 particular HMO doesn't pay the doctor anymore.

24 DR. MUNEY: The HMO pays the external

25 review agency.

120

1 DR. MILLER: They don't pay the -- but

2 the doctors are hired by an external group --

3 DR. MUNEY: That's correct.

4 DR. MILLER: -- and the insurance

5 companies have no choice but to pay on the basis of

6 so many dollars per insured person. So that the

7 doctor is now able to testify against the insurance

8 company because, although they're paid by the

9 insurance company, they're not hired by the insurance

10 company.

11 DR. MUNEY: I understand that, but --

12 again, I think we should give -- Dr. Miller, excuse

13 me. I think we should give doctors that review

14 cases -- and you can say the same thing whether

15 they're reviewing them for automobile accidents all

16 the way through to Lyme disease. Let's give the

17 doctors who are specialists a little bit of credit.

18 They review cases -- when they review cases and give

19 their opinion - excuse me - their medical license and

20 their opinion is on the line if they do go to court,

21 okay, and if somebody does complain against them.

22 So, the fact that somebody pays for their time, it

23 can be insinuated that, of course, yes, they're going

24 to side on the side of the HMO. I have yet to see --

25 MS. MAYERSOHN: But the point is --.

121

1 DR. MUNEY: -- in general practice that

2 happen.

3 MS. MAYERSOHN: The point is there's a

4 debate going on within the medical community, and we

5 want that debate to remain within the medical

6 community and not have government get involved in the

7 debate.

8 DR. MUNEY: Uh-huh.

9 MS. MAYERSOHN: The debate within the

10 medical community has set up sort of two separate

11 camps, from what I understand. And there are the

12 doctors who believe in long-term treatment, if

13 short-term treatment isn't insufficient, and there

14 are doctors who believe in the short-term treatment.

15 And when select your list, I assume you know what

16 camp that doctor is in. And I'm just wondering if

17 there's a bias when you select your doctors to be on

18 the panel?

19 DR. MUNEY: Again, we choose our

20 doctors to review the cases, but ultimately the

21 arbiter is external review. And to Dr. Miller's

22 point, that is HMO-independent in terms of who is

23 paying who and who's deciding what. So, I think the

24 process works -- and I want to come back to that.

25 We're in a very controversial area. There's lots of

122

1 passion, there's a lots of evidence, and there's a

2 lots of people who feel the evidence isn't sufficient

3 with what they see. Ultimately, though, it's an

4 issue across all illnesses.

5 MS. MAYERSOHN: You know --.

6 DR. MUNEY: We have external review to

7 arbitrate that.

8 MS. MAYERSOHN: Okay. Unfortunately,

9 that's part of the problem, that external review

10 appeared to be part of the debate now. You know, you

11 keep using the word "passionate," but I'm not sure

12 I'm comfortable with that word. I think there are

13 doctors who are taking a position because they really

14 believe that they're going to be helping their

15 patient.

16 DR. MUNEY: That's the passion I'm

17 talking about.

18 MS. MAYERSOHN: It's not just based on

19 passion. It's based upon experience, it's based on

20 what they consider good medical practice. So, if --

21 when I think of "passion," I think of --.

22 DR. MUNEY: Assemblyman, I don't

23 disagree with you on that. I think passion is

24 caring, it's concern --.

25 MS. MAYERSOHN: But it's other things,

123

1 too. It's hard medical experience, good physician

2 practicing medicine, and it's not driven by this, you

3 know, emotion that I get a sense of when talk about

4 passion.

5 DR. MUNEY: That's correct. And the

6 emotion part, what -- the scientific studies that are

7 done to try to produce the evidence by which

8 treatment and practice can be implemented for disease

9 is, in a sense, dispassionate in that it removes the

10 emotion from it. And I think that's what we have to

11 keep going back to in medicine. As frustrating at

12 times as it can be, we're only as good as the

13 evidence that exists.

14 MS. MAYERSOHN: Okay. Just one more

15 question.

16 There have been a number of complaints

17 against doctors by the OPMC, and you spoke about one

18 patient complained that was referred to OPMC --.

19 DR. MUNEY: No. Actually, we -- the

20 patient -- the one I'm talking about, the patient

21 herself --

22 MS. MAYERSOHN: Right.

23 DR. MUNEY: -- I guess another

24 physician -- I'm not sure how it happened, but

25 somebody told her to review -- to complain about her

124

1 doctor to OPMC. And, in fact, the specialist that

2 reviewed the cases for us -- we didn't make any final

3 determination because we found out that OPMC was

4 looking at it, because they subpoenaed all the

5 records that the specialist had done. So, we kind of

6 just have it hanging.

7 MS. MAYERSOHN: Can you tell me if it's

8 kind of -- is it practice for insurance companies to

9 refer what they see as inappropriate medical care by

10 Lyme doctors -- is it a practice that they refer

11 these complaints to the OPMC? We're trying to find

12 out how many complaints are patient-initiated and how

13 many complaints have been initiated by the insurance

14 companies or the HMOs or whatever.

15 DR. MUNEY: Yeah, I can tell you a

16 little bit about --.

17 MR. GOTTFRIED: Keep the interruptions

18 down.

19 DR. MUNEY: I'm sorry. I can tell you

20 just a little bit about the process. If a patient

21 such as this one complained to us, we try to get as

22 much of the medical record, send it out for

23 independent reviewers to look at. And then if, in

24 the opinion of the independent reviewers, they noted

25 that there is a significant - in their opinion -

125

1 quality problem, we refer it to our regional quality

2 management committee, which are made up of practicing

3 physicians, not Oxford medical directors, who look at

4 what the issues were. And then they can decide that,

5 well, this physician should be sent a letter

6 outlining -- maybe they -- everything from you need

7 more continuing medical education to it's such a

8 serious offense that we want to go ahead and

9 terminate them from the network. That, of course,

10 happens rarely. There's also a due process part,

11 legally, that we do within the health plan if it

12 comes to that.

13 We will refer something to OPMC if we

14 have terminated a doctor from the network. It is

15 more common occurrence, because of all the dealings

16 OPMC has, that they put out a notice on the doctors

17 that they have suspended privileges on or that they

18 want to revoke the license on. If they revoke the

19 license, obviously we have to eliminate that doctor

20 from the network. If they suspend the license, same

21 thing. If they put the doctor on a focused review,

22 we can choose to do the same, or we can just let the

23 doctor practice, which is what we usually do, and

24 just defer to what the OPMC decides to do.

25 MS. MAYERSOHN: Okay. Could you give

126

1 us a list or the number -- or a list of cases where

2 the complaint was initiated by the HMO or the

3 insurance company?

4 DR. MUNEY: Oxford's experience?

5 Oxford's experience in the past year, I can tell you

6 we have only that one case that -- to our knowledge,

7 anyway, that we were informed of, that the patient

8 made a referral to OPMC. And, again, the only away

9 we know that is because they subpoenaed our records.

10 If members complain about --.

11 MS. MAYERSOHN: Do you have any

12 knowledge of the insurance company complaining?

13 DR. MUNEY: I would only have knowledge

14 of Oxford's. Again, the only way that we would find

15 out -- we could have a dozen patients that are

16 complaining to the OPMC. We don't know unless --

17 because the OPMC keeps that confidential while their

18 doing their review.

19 MS. MAYERSOHN: Thank you.

20 DR. MUNEY: Thank you.

21 MR. COHEN: Good afternoon, Doctor. I

22 say this sincerely, I thank you for coming. As the

23 Chairman pointed out, the State Department of Health

24 has declined to come. And I've looked at the witness

25 list, and you're the only insurance company that has

127

1 appeared. And I admire your political courage in

2 appearing here this afternoon. I'm sure you didn't

3 anticipate a pleasant experience -- no, I say that

4 sincerely.

5 DR. MUNEY: Thank you. It's

6 appreciated.

7 MR. COHEN: I'm sure you have heard,

8 possibly suspect, that the residents of New York

9 State believe that medical insurance companies deny

10 claims for services and procedures in an arbitrary

11 manner. You referred to the external appeals review

12 process. I'm sorry, I don't have the publication

13 with me. I believe it was produced by the State

14 Insurance Department. And it was a recapitulation

15 statistically --

16 DR. MUNEY: Yes.

17 MR. COHEN: -- of the years 1999 and

18 the years 2000 - perhaps you're familiar with what

19 I'm referring to - of external appeals cases. And

20 industry-wide, I believe the reversal rate in 1999

21 was 52 percent, and I think in 2000 it was 47

22 percent. And, please, I'm not saying this to be

23 mean, but my true recollection was that the Oxford

24 reversal rate was 80.

25 DR. MUNEY: No. Actually, our --

128

1 Oxford's reversal rate was the best, if you will,

2 among all health plans, meaning --

3 MR. COHEN: It was?

4 DR. MUNEY: -- our -- I can tell you

5 our uphold rate was, I believe, 63, 64 percent, which

6 is substantially higher than other health plans.

7 Said the other way, our, you know, overturn rate was

8 in the 30s.

9 MR. COHEN: All right. So --.

10 DR. MUNEY: I, again, can get you the

11 exact -- they're actually better.

12 MR. COHEN: For purposes of this

13 discussion, we'll accept the one-third reversal rate.

14 DR. MUNEY: Right.

15 MR. COHEN: If Oxford is basing its

16 decisions on evidence-based medicine, then what are

17 the people on the external appeal review panel doing?

18 Because, obviously, they're not basing it on

19 evidence-based medicine. What are they basing their

20 decisions on?

21 DR. MUNEY: Yeah. No, I think it's an

22 excellent question, and I think the answer is exactly

23 the part and parcel of why we are sitting here today.

24 Because when -- no matter what illness you get that

25 you're reviewing ultimately, when it gets to that

129

1 level you are dealing in shades gray. I think Dr.

2 Liegner said, you know, everyone loves to see, you

3 know, black and white, but it just -- with certain

4 patients, with certain illnesses, it is just not that

5 way. So, I think what your you're seeing is very

6 bona fide differences of opinion.

7 Now, we have very detailed analysis -

8 which I can get for you - on what our overturns were

9 for in external review. And, frankly, there are some

10 that clearly don't fit the guidelines at all, that we

11 have written to -- not just Lyme, but -- and,

12 frankly, not so much Lyme, but other areas -- that we

13 have written to the Department of Health and Dr.

14 Gesten about what is the quality control that even is

15 going on external review if these things clearly

16 don't fit the guidelines. And we attached the

17 guidelines, et cetera. But at the end of the day, I

18 think it is acceptable, honest disagreement about

19 what the appropriate clinical course should be for a

20 particular illness. That's just inherent in the fact

21 that, you know, medicine has a lot of variables.

22 MR. COHEN: You know, once again, the

23 public's negative attitude towards medical insurance

24 companies -- some of it's shared by myself. There's

25 the following thought processes: That the decisions

130

1 to deny services -- many of them, if not all of

2 them -- I'm sorry, many of them are arbitrary, the

3 logic being as follows: If you're reversed, you're

4 going to pay for the service. And if a person is

5 denied and does not file an appeal, and perhaps if

6 they did file an appeal, there would have been a

7 reversal. Well, this is money that's being saved by

8 the medical insurance company.

9 DR. MUNEY: Uh-huh.

10 MR. COHEN: That's the thinking of many

11 people. I would just like to finally --.

12 DR. MUNEY: Would you like me to

13 respond to that briefly?

14 MR. COHEN: If you --.

15 DR. MUNEY: Yeah. I mean, just very,

16 you know, briefly.

17 I can speak for Oxford, and I can speak

18 for the fact that we have a very rigorous medical

19 director consistency program in place that literally

20 examines the doctors on their decisions compared to

21 what the guidelines are that are published by

22 professional societies. And people that make wrong

23 decisions need to correct that, and we actually have

24 a second tier review in our process that examines

25 against guidelines to make sure that we didn't make a

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1 mistake. So, for Oxford, I can sit here and tell you

2 we pay a lot of attention to trying to get it right.

3 MR. COHEN: Finally, what -- I think

4 that I'm getting eventually to a possible, well,

5 progressive step -- not only in Lyme disease, in all

6 medical claims and services. Dr. Liegner referred to

7 a seven-year-old patient that was receiving

8 intravenous antibiotic for a period of, I believe,

9 six months, and there was a physician reviewer for

10 the corporation, which denied further intravenous

11 antibiotic treatment. And Dr. Liegner wrote a letter

12 to this physician -- and if I could read just a few

13 sentences.

14 (Reading) "Mr. and Mrs. X" -- meaning

15 the parents of the seven-year-old child. "Mr. and

16 Mr. X cannot afford to pay for X's for the treatment

17 unless they are reimbursed by their insurance

18 coverage. To suspend treatment when this child is

19 showing progress in terms of diminished seizure

20 frequency, resumption of ability to take sustenance

21 by mouth, and ability to walk is both cruel and

22 lacking in compassion. But more than this, it is my

23 considered opinion that for a physician to fail to

24 treat this patient intensively at this point, or to

25 prevent such treatment by one's actions as a

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1 third-party administrator review physician, would

2 constitute criminal medical negligence."

3 Now, Mr. Liegner -- Dr. Liegner was

4 incorrect, because in this the state an insurance

5 gatekeeper is not subject to criminal or civil

6 medical malpractice suit. I'm going to assume that

7 Oxford is opposed to changing the law so that

8 insurance gatekeepers would become subject to such

9 lawsuits, both civilly and criminally. I can imagine

10 what your opinion would be, but do you understand

11 from my point of view and the public's point of view

12 why we feel that if insurance companies were subject

13 to medical malpractice, that would remove the climate

14 or the assumption that insurance companies are

15 denying claims in an arbitrary manner. Because if

16 they were subject to medical mal., they -- it would

17 be just too costly and expensive for them to continue

18 to engage in acting in such a manner.

19 DR. MUNEY: Well, in the case you just

20 cited, I'm going to assume that Dr. Liegner, as well

21 as the patient's next step -- if it hadn't been, it

22 should have been to external review. And the fact

23 that based upon what external review decides is what

24 the insurance company does. And, again, these are

25 honest disagreements among clinicians.

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1 To the question as to whether that

2 substantiates the need for having HMOs open to

3 litigation --

4 MR. COHEN: If I could --?

5 DR. MUNEY: -- I think that's not the

6 case if external review is doing its job. And I

7 think the track record in New York is that it is.

8 Otherwise, what's going to happen is if malpractice

9 suits are filed right and left, then all you're going

10 to do is drive up the cost in general of health care

11 when, again, we have a perfectly appropriate system

12 already in place, which is external review.

13 MR. COHEN: I mean, just as an

14 addendum, Doctor, with respect to this seven-year-old

15 patient, antibiotic therapy was stopped on 12/3/96,

16 the patient died on 1/30/97. This was before

17 external review. There was no external review in

18 this --.

19 DR. MUNEY: Again, I can't comment on

20 the facts of the case, whether the diagnosis was

21 correct, whether there were second opinions. But,

22 again, we're in the here and now, and the here and

23 now -- I think we're all confident that external

24 review would help that case.

25 MR. COHEN: Thank you.

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1 DR. MUNEY: Thank you.

2 DR. MILLER: If I could just make a

3 comment, though. If an insurance company says no,

4 and then it takes someone else to say no, the

5 insurance company is wrong, the answer should have

6 been yes, that doesn't exonerate the insurance

7 company. Under the law, you're absolutely right.

8 But for the insurance company to say, "Ah, see, we

9 were perfectly fine," because there's someone else to

10 step in and say yes is not the answer. The question

11 is, why should the insurance company have said no in

12 the first place, and how often -- I mean, it's a

13 strange circumstance that we have.

14 MR. GOTTFRIED: We're getting a little

15 far afield from the specific question of the hearing.

16 DR. MILLER: But, Richard, this is what

17 goes on all the time. If the insurance companies had

18 said yes to all of these patients --.

19 DR. MUNEY: Dr. Miller, you're assuming

20 the insurance companies are saying no capriciously

21 and not according to guidelines.

22 DR. MILLER: You caught me.

23 DR. MUNEY: Well, I would --.

24 MR. GOTTFRIED: Let me interrupt.

25 DR. MUNEY: Dr. Miller, I would advise

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1 you to look at our medical director consistency

2 process as I outlined.

3 MR. GOTTFRIED: The Assembly has a bill

4 on legal liability of health plans. We've passed

5 that bill several times -- I think, unanimously.

6 That legislation - which I'm the author of, so I like

7 it a lot - is not the focus of this hearing. The

8 purpose of this hearing is to focus on whether

9 chronic Lyme and long-term antibiotic treatment are

10 where those items are on the spectrum of reasonable

11 medical practice. If we have further questions on

12 that point for Dr. Muney, we should pursue them, but

13 I think we have probably pretty much exhausted him

14 and the questions.

15 MS. MAYERSOHN: Richard, I just have --

16 and it's not really a question, but I was just

17 wondering. If -- since you appear to be comfortable

18 with the Connecticut law, could we count on working

19 together to achieve something similar in New York?

20 DR. MUNEY: I want to clarify that.

21 I'm comfortable with most aspects of the Connecticut

22 law. I think that the principle of the Connecticut

23 law, again, is evidence-based medicine guidelines.

24 And to the extent that that principle can be

25 incorporated in anything that New York State does, I

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1 think that would be okay. But I want to hasten to

2 add that, again, we have a perfectly good mechanism

3 in place right now, which is external review, and

4 presumably the impartial experts that are reviewing

5 these cases are doing it according to evidence.

6 MR. GOTTFRIED: And let me just note

7 that Dr. Muney is Oxford's medical director. They

8 also have a government relations director. But I

9 think it is a safe bet that we will be having further

10 discussions about the Connecticut legislation.

11 With that, I'm want to thank Dr. Muney

12 for his testimony and being here today. I appreciate

13 your being here.

14 DR. MUNEY: Thank you for the

15 opportunity.

16 MR. GOTTFRIED: Okay. We are now going

17 to take what will be advertised as a five-minute

18 break, as they say in the long-term care field, for

19 ambulation and toileting, and we will then be back.