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President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry

Bethesda, Maryland
Final Meeting
Thursday, March 12, 1998

Transcription of Meeting

Agenda

Chapters for Discussion during the Final Meeting
[The following chapters do not represent final versions of the Commission's work]


Transcription of Meeting

The Commission met in Room E2 of the National Institutes of Health's William Natcher Conference Center, at 10:05 a.m., the Honorable Donna Shalala, Secretary of Health and Human Services, and the Honorable Alexis Herman, Secretary of Labor, Co-Chairs, presiding.

Co-Chairs Present:

    Donna Shalala
    Alexis Herman

Commissioners Present:

    Betty Bednarczyk
    Donald Berwick
    James Chao
    Robert Georgine
    Val Halamandaris
    Sandra Hernandez
    Nan Hunter
    Sylvia Drew Ivie
    Risa J. Lavizzo-Mourey
    Sheila Leatherman
    J. Randall MacDonald
    Beverly Malone
    Gerald McEntee
    Paul Montrone
    Phillip Nudelman
    Herbert Pardes
    Ron Pollack
    Marta Prado
    Christopher Queram
    Robert Ray
    Thomas Reardon
    Kathleen Sebelius
    Steven S. Sharfstein
    Peter Thomas
    Mary Wakefield
    Gail Warden
    Alan Weil
    Sheldon Weinhaus

Staff Present:

    Janet Corrigan, Executive Director
    Richard Sorian, Deputy Director
    Ann Page


Agenda

Introduction

Report from the Executive Director

Discussion: Draft Chapter Ten: "Reducing the Impact of Errors"

Consideration of the Commission's Final Report to the President

Final Consideration of the Executive Summary and Chapter Ten


Introduction

(10:05 a.m.)

Secretary Shalala: Welcome to the tenth and final meeting of the President's Advisory Commission on Consumer Protection and Quality in the Health Care Industry. It's a pleasure to see all of the commissioners and members of our fan club here today. Let me say a couple of things.

First, it really is an exciting day, not only because we're going to finish, but because there's been an extraordinary year of very hard work. I've chaired a lot of commissions, I've worked with a lot of commissions, I don't think I've ever worked with a commission in which the members have worked harder or been more enthusiastic. I think the quality of the report that we're going to present to the President and to the Vice President is a reflection of that hard work and thoughtfulness.

I want to obviously thank Janet and the staff, and I'll have some things at the end of our meeting to say about the quality and the kind of vision and leadership that Janet and her colleagues have brought to this enterprise, and I'm sure all of you will. I'm going to leave time at the end of the meeting for all of us to make our final comments, and it will be a final going around the room so everyone can make final comments on the work of the commission.

Let me also thank the audience. I actually have recognized people. Many of you have in may ways been to as many meetings as the members of the commission have on assignment for your various organizations. And I think the fact that we have had so many observers here on a regular basis has actually made a difference in terms of the continuity of the kinds of advice that so many of the organizations have given us and individuals have given us on the commission's work.

Let me say that we're going to do a couple of things today. First, a final reading of the last chapter, which has been a chapter difficult to pull together.

Secretary Herman.

Secretary Herman: Good morning.

Secretary Shalala: But as a professor of public policy and since all of you are pros you know that each issue has its own timing. What we've been able to do, I think, is a giant step in moving the agenda on quality and consumer rights literally a giant step. Some of the issues we're ready to move right into legislation. Clearly the patient's rights, we're prepared, some of it, to move into legislation, some of it to move in regulation. It certainly lit a fire under the government's own programs.

On other issues we were able to provide detailed guidance to public policy makers, and in particular to the private sector in terms of the kinds of institutions that ought to be standing at the end of the day to provide leadership.

On some issues we were only able to outline what the terms of the debate ought to be, or even just raise the issue, and there should be no apologies for that. It's not unusual in public policy when you take on a major set of issues for some of them to be ready to move where there is consensus and even when it's hard consensus that we were able to put on. And others where we can simply raise the issues and wait for another day, although hopefully not too far along, where others can, and many people in this room will participate in those broader debates, can reach a consensus. So the fact that the final report has major issues at different stages of development is what I would describe as normal.

The important thing, as the true historians of these issues like Don Berwick will tell you, is we actually are moving a major area of public policy forward dramatically. We have gotten the attention of the policy makers, we have gotten the attention of the private sector, which is struggling to deal with many of these issues along with those of us that work on the government programs.

This is the first time we have convened all of the stakeholders in a civilized debate to see how far we can move the agenda together. And we have been sensitive to the needs of people in the health care system, some of whom have not been served well by the health care system, although not necessarily by any particular form of organization of the health care system.

As all of you know, I have been as hard-nosed about fee for service as I have been about closed end HMOs, and I think we all should continue to do that because we must hold the entire health care system to a very, very high standard. I believe this is a remarkable report put together by the most thoughtful group of individuals that I've ever worked with in health care, and I look forward to both finishing the chapter and as well as getting a chance to hear what all of you might say about both what we've done and what we need to do in the future.

Secretary Herman, would you like --

Secretary Herman: No. I will only just echo what you've just said, Secretary Shalala, to say that this is a very historic day, and I look forward to the completion of our work today. And I want again to thank all of the commission members in advance for their contributions to what is an extraordinary product.

You know, down home in Alabama we'd say this is a glory hallelujah day, and that's really how I feel about where we are at this point in time. So I am looking forward to the completion of our work and especially now getting on with the concluding business in chapter ten.

Secretary Shalala: Thank you very much.

Let me say that we've also done all of this in the sunshine. Whoever thought that you couldn't follow the FACA rules and actually produce genuine substance ought to come and look at this commission as a model. And the leadership of Janet Corrigan and her colleagues has been critical in that.

And, Janet, why don't I turn the meeting over to you. Just by noting again what I said at the beginning and that is I was very reluctant when the President made the appointment with the idea of Cabinet officers chairing a private commission. I didn't know how it would work. In some ways we're worse than politicians, getting us to spend more than 15 minutes sitting still on a subject is extremely difficult. Let me say that my long-time friendship with Secretary Herman has made this much easier and frankly it's been good for me, so to dig deeply into an issue with a lot of very good coaches.

Janet?

Report from the Executive Director

Executive Director Corrigan: Thank you, Madam Secretary, and thank you for your kind comments.

I'd like to just take one minute to acknowledge my staff and the contributions that they've made. Richard Sorian, Ann Page, Beth Docteur, John Dicken, Peter Nixon, Marilyn Park, Karen Titlow, Chip Malin, and Mary Gerald, if you'd all please stand up.

There's always a sense at the end of this process and a bit of regret that you couldn't do more, but when you take a look at the report I really think, I'm just real pleased that the staff has done so much, and I can't tell you how hard they've worked, they really have.

A little bit of housekeeping. There will be an event at the White House tomorrow to present the final report to the President and the Vice President, and that scheduled for 2:40. And I know that's a little bit difficult for some of you, but that is the plan at this time to have that at 2:40. We'll give you more details about that a little bit later.

Today we have just two items, just two items, on the agenda, and the first is to move through chapter ten which has been revised a couple of times since the last time you saw it, and it's back again before you. And then we want any last minute comments that you might have on all of the other chapters of the report which were forwarded to you both redlined version as well as clean copies. And for all of the other chapters, as you know, all of the substantive issues on those chapters were raised prior to this and we pretty much brought them to a close at the last meeting, so we're really asking you to do a quick check and make sure that we've made all the changes that you asked us to make at the last meeting. Thank you.

Secretary Shalala: Thank you.

Mr. Pollack?

Commissioner Pollack: Yes. I just wanted to ask a question of staff or the secretaries. I heard last night from a normally reliable person in the media that the CBO actually had scored our proposed bill of rights, and what I was told, and I don't know if this is accurate and that's why I'm making this inquiry, that CBO scored this as adding 0.3 percent on to premiums, which would be an extraordinary statement if true. Does anybody know whether this in fact is true?

Secretary Shalala: The answer is that CBO has made no announcement and therefore we can't comment on that. Can't ask a government official that question. I'm not allowed to comment on CBO's.

Secretary Herman: I think it's fair to say that CBO is working on the issue, but we don't have an official report from the Congressional Budget Office.

Secretary Shalala: Does this suggest that you might want to add some, if it's actually that low?

Commissioner Pollack: No, I thought that Secretary Herman when she talked about this being what's a growing hallelujah day --

Secretary Herman: A glory hallelujah.

Commissioner Pollack: -- a glory hallelujah day, even better, that we were going to add to that.

Discussion
Draft Chapter Ten:
"Reducing the Impact of Errors"

Secretary Shalala: Let's move on to the next, let's move on to the next, the last chapter. And I'd like to ask Sandra Hernandez and Gail Warden to begin the discussion, and I think Sandra is going to begin it. The chapter is called "Moving Towards Error Free Health Care."

Commissioner Hernandez: Thank you, Madam Secretary.

Since the commissioners last saw this chapter there has been obviously significant re-revisions of it. The subcommittee had two conference calls since our last meeting which the majority of the subcommittee participated on, as well as a number of other commissioners who have sat with us during sort of our extended subcommittee meetings looking at the specific issues both related to reducing errors and trying to create an environment where errors are more readily identified and therefore potentially corrected from a systematic point of view and then on the more difficult issue of remedies and compensation.

What you see before you today I would characterize as the very small piece of common ground that we could achieve given strongly divergent opinions about this issue that were represented on the commission.

I think it is important, as you mentioned Secretary Shalala, that this commission has worked on 12 full chapters of I think a phenomenal analysis and policy, recommendations that are highly relevant and in may ways readily applicable. And the work of the commission overall has been to find that common ground.

Despite that, I think that the question about whether there is an evenness or inequitability in remedies is one for which we have again very strongly divergent opinions on this commission. And I think that what this chapter tries to do is not to detract from the considerable work of the rest of the report, but to really to try to identify that area that constitutes that small piece of common ground that we could agree to.

I don't believe, contrary to some of our discussion at the last meeting, that more conference calls, more testimony from experts, or more committee meetings would have identified a broader common ground on this issue for better or for worse. Likewise, I don't think any commissioner believes that this issue is resolved outside of this room. And I think what we need to try to do today obviously is resolve it inside the room as a full commission as best we can. But ultimately I think consumers and stakeholders and ultimately legislators will have to take this debate the next step forward.

I do think that it is important for all of us who play whatever role it is we do in the health care industry, whether that's as providers or policy advisors, as advocates, or as consumers, to recognize that we do share some responsibility in what is the least common denominator for those unfortunate individuals which we've sometimes characterized as anecdotal cases for whom injuries, sometimes serious, sometimes not, but do occur that are potentially preventable. And I think from a quality perspective, which has been the orientation of our work, that we all need to sort of look at those unfortunate cases, not so much as anecdotes for which more or less analysis might ought to be needed, that those individuals really reaped the most unfortunate aspects of our health care system and that ultimately we share some responsibility in helping the policy move forward around some better resolve for that.

The chapter's recommendations, the two recommendations that are identified on page one in the revised version, which everybody should have a copy of, I think there was little disagreement about at our last meeting. There was discussion on the conference call about the extent to which we would want to discuss in any way, shape or form, an ongoing dialogue which was in our third recommendation about the questions of remedies. In some ways that's a moot point because that ongoing dialogue is going to occur with us or without us, and with the recommendation, without the recommendation.

Nonetheless I would sort of put the chapter in the hands of the committee at this point and simply say it does represent the least common denominator of common ground that we could identify, given the very strongly differing opinions.

Secretary Shalala: Gail, do you have anything to add?

Commissioner Warden: Not a lot. I think Sandra has articulated it very well.

I guess I would only remind the commission that there has been a tremendous amount of effort put into trying to forge a document in this chapter that on the one hand identifies the issues, but at the same time is sensitive to the arguments on both sides. And we've tried through testimony with five different panels in which we heard a lot of conflicting opinions among the people on those panels. We've tried to back up and articulate some principles that we thought might be a way of addressing this issue going forward. And we've also tried to use language in the chapter that tries to be steer away from being judgmental about the issues on either side of the arguments.

And I think that, as Sandra said, this is probably the closest we can come to what we think are a chapter that on the one hand isn't silent, but on the other hand identifies the terms of the debate, as the Secretary said, and with the hope that it will raise the issues that then will be addressed in time.

Secretary Shalala: Good.

Steve, and then Bob Georgine.

Commissioner Sharfstein: Yes, I'm a member of the subcommittee. And I think Sandra put it very well that this the small common ground and least common denominator on this very contentious subject. One concern is that by reading this one may assume that there is possibly a consensus that everything is okay when it comes to remedies available under ERISA, and there was no consensus on that. Everything is not okay, and there are strongly held feelings on the other side of that.

But we could not, despite a tremendous amount of effort, and very long telephone subcommittee meetings, and I was on a car phone and ended up in a parking lot on the car phone, and I must have looked like I was quite crazy talking for that long in the parking lot, but there was no consensus on what could or should be done given the cost and benefits of potential change. So that's why we are where we are.

Secretary Shalala: Bob?

Commissioner Georgine: Unfortunately I wasn't able to participate in the conference calls, and I think Sandra pretty much touched what I was going to ask in her opening remarks. But the third recommendation where we agreed that we should engage in a national dialogue regarding the form of compensation methods for individuals who are injured in a wrongful care decision, I'm assuming by what Sandra said that we're going to have dialogue on that anyway. And is that why it was left out?

Secretary Shalala: I think that they couldn't get consensus on the third recommendation either. So I think that just by raising the issues in some ways the commission starts the dialogue, and that others including the people around this table will have to continue that dialogue. This is clearly an issue in which we're taking a smaller step forward than we are in some of the other issues.

And I made the point that some issues are ready for big steps where you could build the consensus, and some issues clearly aren't. And I know people are disappointed, but if you look at the overall document, look at it in the context of that. So I think these are the -- what you see here is what the subcommittee could agree on, and in a sense that we could not get wider consensus on the commission. So I think that's the answer to the question.

Kathleen?

Commissioner Sebelius: Thank you, Madam Secretary.

I also am a member of the subcommittee and I think that Bob's question is important for the group to understand. If you recall at the end of the last meeting we left and the staff left with the direction that the chapter would be reformatted around the three recommendations which were in the original chapter ten which you all saw at our February meeting.

We reached a fundamental roadblock at the first conference call where it was very clear that there was no consensus on the third recommendation, which if you'll recall talked about moving the dialogue toward a standard where remedies would be equitable, fair, exact, and that became a key point. So if you start with no consensus on that point and back out of that, you arrive where we are today.

I think that is sort of a different sense than a lot of the commission members had as we left the last meeting, but it becomes very clear after I would say an hour into our first conference call that there really wasn't consensus about that third recommendation, that we could not move forward assuming that that was the goal that we were all trying to reach, and so anything that referred to that goal or led us toward that goal has now been removed from this chapter.

Secretary Shalala: Betty?

Commissioner Bednarczyk: I just want to say that this is such an important issue, and while I appreciate the diversity of the views and the extent of the severity of the problem, to not call for some type of action even in the form of a national dialogue to figure out the solution I believe would be a serious omission to our work.

Secretary Shalala: Do you want to recommend that to see if we can get consensus on the national dialogue, the call for a national dialogue?

Commissioner Bednarczyk: Yes.

Secretary Shalala: Okay. I'll take comments on that as well as on anything else you want to have come in.

Does anyone else have any additional comments?

Ron?

Commissioner Weil: Madam Chairman, I have a couple of specific on the text, but I guess maybe it would be better to do --

Secretary Shalala: No, no, this is specifics.

Commissioner Weil: Go, okay. Well, sorry.

Secretary Shalala: Give me the language on the national dialogue too so I can read it.

Commissioner Weil: Let me start with a couple of specific comments on the text, and I am not working -- sorry, I marked up a document called "Draft chapter ten revised 3/10/98 not to be confused with draft chapter ten revised 3/10/98" which --

Secretary Shalala: Do you have the redlined version?

Commissioner Weil: No, I have a clean version, but not the one that was on our desk this morning. It was the one that came to us yesterday or the day before.

Secretary Shalala: I'm sorry for the confusion. We should change the date on it. There is one that's in front of you today that has some very minor changes on it. I mean you can take a look at it. They are redlined, so they're easy to spot. Redlined means blacklined. The blacklined here. You'll see it right away because there is a sentence added right at the beginning under "Evidence of errors."

No sooner did we send out the 3/10 draft, the day before yesterday and we did get some comments both from Ben Lytle and from Randy MacDonald, and we've incorporated to the extent that we could those suggestions that we thought made the document stronger and were consistent with the discussions thus far on the subcommittee. There is one issue that I'll raise in a couple of minutes that was in a letter from Ben Lytle that we did get some information from the general counsel on to clarify the legal issues. But you should be looking at the one in front of you, and there are just minor changes I believe, and you will see them redlined.

Commissioner Weil: Okay, so if I work from the blacklined copy that was on our desks today, on page two after the four bullets is a sentence that says "Much less is known about the incidents of injuries." It seems to me that after that sentence we need to say "One reason we know so little is that there is no systematic mechanism for gathering information about such injuries." This is not just sort of --

Secretary Shalala: That's fine.

Commissioner Weil: -- magical, there is a reason we don't know.

Secretary Shalala: That's fine.

Commissioner Weil: At the end of that second page, the first sentence says "Although the efforts of plans to reduce over utilization have likely had a positive overall impact on cost and quality." I don't know that we got evidence of that, and I would feel more comfortable if we said "Efforts by health plans to reduce over utilization when based on evidence showing that certain procedures or services are unnecessary may have a positive impact on cost and quality." That's consistent with our view of the definition of quality as opposed to just utilization.

Secretary Shalala: That's fine.

Commissioner Weil: In two places, one in the sentence that follows the one I was just referring to --

Secretary Shalala: Are you still on page two?

Commissioner Warden: -- it's now the sentence that carries from page two to page -- I'm sorry, yes, the very last line of page two.

Secretary Shalala: That starts "An inappropriate" --

Commissioner Weil: "An inappropriate," yes, "an inappropriate decision."

Secretary Shalala -- "An inappropriate decision," okay.

Commissioner Weil: Yes, we can fix that. "Not to authorize where it is ultimately determined that the service was medically necessary." I would like us to remove the term "medically necessary and," because I'm not sure that we should be adding force to the use of medical necessity as the standard for coverage in insurance contracts when so many services, particularly for people with chronic needs, are not in the strict definition of medical necessity, but are necessary for functioning. It seems to me we ought to be fitting the contract terms, not relying on medical necessity in our deliberations. I don't know if that makes sense to people.

Secretary Shalala: Randy?

Commissioner MacDonald: I guess I'm having a problem. I'm having a difficult time understanding the differentiation. I mean why would we -- something? We just got done talking about procedures that are not necessary --

(Whereupon, microphone malfunctions.)

Secretary Shalala: Randy, you're going to have to put your microphone on. I'm sorry.

Commissioner MacDonald: There's a conspiracy here. You put me off guard now.

Alan, I mean I guess where I'm having a problem, if we're talking about unnecessary medical procedures, then I think the contrary to that is, is that we're calling for medical necessary procedures, and I think that was our intention about putting it in.

I'm not quite sure where you're going from the contract language standpoint. I don't want to argue it on a legal basis. That's all I'm trying to say.

Commissioner Weil: Let me see if I can clarify. The sentence says "Inappropriate decisions where it's ultimately determined that the service was medically necessary and covered by the plan." If the plan, most plans say it must be medically necessary to be covered, so it's superfluous to say that it has to be medically necessary. Because if the plan says it must be medically necessary and it's not, it's not covered by the plan.

My problem is there is great peril in the term "medical necessity," as the linchpin for coverage decisions, and I don't think we've talked about whether or not that's the appropriate standard. And I don't feel that we should be echoing a standard that we've not discussed with respect to what services should be covered, so I'd rather just rely on the plan.

Secretary Shalala: Alan is taking the more conservative position than you are.

Let's see if anyone else wants to get into this.

Tom, specifically on this issue?

Commissioner Reardon: Yes.

Secretary Shalala: Yes, okay.

Commissioner Reardon: I'm having difficulty agreeing with Alan because I think the issue is where insurance coverage or where the determination was medically necessary and as a covered service and wasn't provided.

I'm not sure I'm understanding, Alan, where you're coming from because medical necessity, not medically necessary is a very commonly used term of why we provide services. I mean would we provide services when it's medically unnecessary?

Commissioner Weil: The issue is not necessity, it's the medical. If you have a benefit for long term care services and those services might improve your functioning or might make you more able to live independently, and you've purchased a contract that's designed to improve your ability to live independently you might have a medical necessity test for certain services. And I think that's a good thing. It's not that I want us to be paying for unnecessary services, it's just that there are contracts that cover things other than medical services. And so to put the word "medical" in our definition of what should and shouldn't be covered seems to me a stretch.

I will gladly drop this, if I am alone, but --

Secretary Shalala: Let me go to Peter, Kathleen and Ron.

Commissioner Thomas: You're not alone. You're talking my language at least.

And this is an issue that comes up time and time again with disability, with services that are provided to people who need ongoing supports, and types of health and health related services that enable them to be functional. This is right down what I have been trying to talk about for months and in fact years.

And I support Alan. It's difficult to raise this issue on the last day in kind of this way, but the fact is, is that he's not alone.

Secretary Shalala: Kathleen?

Commissioner Sebelius: Ditto. And I don't think, Randy, given the fact that, as Alan said, covered by the plan encompasses a determination often of medical necessity because that's often written into the contract language. We're not really changing the import of contracts. But I think the debate that often comes to our office is what does medical necessity mean, how is it determined if it differs between the medical director and the primary care doc who makes that determination.

So this is probably the most contentious term in any insurance contract that I see on an ongoing basis. It often limits benefits to mental health services where somebody has 30 days of outpatient care, but they can't get it because of some kind of gatekeeper.

So I think removing that still says, and covered by the plan which incorporates that kind of decision, but it doesn't give an additional endorsement to the terminology of medical necessity, which we really haven't discussed or examined in any kind of detailed way.

Secretary Shalala: Randy, do you want to respond to that and then I'll keep moving?

Commissioner MacDonald: Yes, it's interesting.

(Whereupon, microphone malfunctions.)

Secretary Shalala: There will be more debate.

Commissioner MacDonald: Thank you for the promise.

I guess where I keep getting hung up is that something can be covered by the plan and a person can ask for it, but if it is not medically necessary, it shouldn't be given. And perhaps all of you are right, that we have not used the term "medically necessary," I mean I don't recall that, and I'll take it for that, for your word, but it is quite common in my mind from a fiduciary standpoint of what I look at in that regard.

And so I guess all I'm worried about is that just because something is covered doesn't necessarily mean, I think to Tom's point, that I have to provide that service. And that's the issue. A person can come in and say I can have this taken care of, but if it is not necessary to do, then why perform it. Because one of the things that we're trying to do is to get waste out of the health care system, we're trying to eliminate that which is unnecessary. And we know there has been evidence that has been provided to us that there are things are done that are inappropriate. And so consequently I think that's why this language has been added.

Secretary Shalala: Yes, I think we may be -- we actually don't have a disagreement on the substance, we're trying to figure out how to say it. And I think some of you are talking about medically appropriate as opposed to coverage.

Let me keep going around the room and then we'll figure out how to resolve this because I don't hear a big disagreement.

Ron?

Commissioner Pollack: I just wanted to reserve my spot on the cue for the discussion of the whole chapter, not on this particular point.

Secretary Shalala: Okay, all right.

Okay, Kathleen, Beverly?

Commissioner Malone: I want to speak in support of Alan's statement. And particularly I think some people may equate prevention with waste.

So, Randy, I'm concerned that those folks who would say that preventive services are not medically necessary so therefore they shouldn't be covered, and as well as the mental health piece. So those kinds of concerns, and I don't think we would be taking away the essence of those things that are medically appropriate within the plan, but we wouldn't be adding that emphasis, those boundaries that would actually limit and give people permission to move away from the kinds of activities that I believe are central, such as prevention.

Secretary Shalala: Let me go to Nan and then to Steve, and then I'm going to let Janet make a recommendation.

Commissioner Hunter: Madam Secretary, I really have a process point, it's not directly on this point, but if you would be so kind perhaps as to call on me when we resolve this particular point of language, I would like to suggest something about process for the discussion.

Let me just say it. My suggestion, it will be so anti-climatic after that.

Secretary Shalala: Go ahead.

Commissioner Hunter: My suggestion is that perhaps on this chapter we, rather than call on individuals for all of their comments, that we proceed perhaps by portions of the chapter that I think that might lead to a more kind of coherent discussion. And so perhaps we could sort of start with any overall comments and then the chair could divide it in so much --

Secretary Shalala: Okay, I actually was going to go back to overall comments and then move through the chapter. So we just got into something specific right away.

Okay, Steve?

Commissioner Sharfstein: One suggestion would be to say that it's ultimately determined that a needed service was covered by the health plan. I mean that would be one way to resolve it. Don't use the word "medically necessary," use the word "needed service" and --

Secretary Shalala: Is everybody okay with that?

Randy?

Commissioner MacDonald: Who determines need?

Commissioner Sharfstein: There was no indication here who would determine what was medically necessary, so I think to say "a needed service," so I think that's -- I mean you leave it, that becomes the discussion.

Secretary Shalala: Janet, do you have --

Executive Director Corrigan: I was just going to say that it seems like the term "medically necessary" is quite loaded. And similar to where Steve was going, what about just saying "Determined that the service was appropriate and covered by the plan" so it's a bit more general, not getting into the details and legal explanations of medically necessary.

Secretary Shalala: Appropriate --

Executive Director Corrigan: But you're still speaking to the fact that it should be an appropriate service.

Secretary Shalala: Sandra and then Tom?

Commissioner Hernandez: Yes, I think, Janet, that's a good suggestion particularly because this chapter goes out of its way to emphasize inappropriate decisions. And we took the liberty in this chapter to try to define what that was. I think in this version to put "appropriate" works with the other language and semantics we've been using in the chapter and is less loaded.

Secretary Shalala: Okay, Tom?

Commissioner Reardon: I think we're going to have to come to a compromise, but I'm still concerned because we've had a system for three or four decades where patients could demand what they wanted and generally receive it whether it was necessary or not because insurance covered it. And that's an argument that we always hear in the exam room, is well why can't I have this, I want it and my insurance covers. And it's becoming more and more clear that the physicians are having to say well I'm worry, I know you want it, but it isn't necessary.

And so to say that just because it's covered you're going to provide it, we're trying to get that out of the system. So there's going to be a compromise, but I think we need to understand that. That, you know, we can provide more care and the patients can demand more care than we can possibly afford, and somewhere along the line we have to make some decisions about what's necessary.

Secretary Shalala: Let me close down this discussion, unless you've got something specific, Steve?

Commissioner Sharfstein: No, just that's why I like the word "needed" because appropriate is very broad. There are a lot of services which could be appropriate, but may not be necessary. So I think that that's why "needed" is important, "needed service," and that's what I would prefer.

Secretary Shalala: Without objection, done.

Okay, what I'd like to do now is to let everybody give us whatever their general comments are in the chapter, then I will move through section by section in the chapter. Make your general comments, but if you have specific recommendations for changes, I will take those as I go around the room on specific areas.

Let's start with Ron.

Commissioner Pollack: Thank you, Madam Secretary. Let me just say before I get into my comments, I want to express thanks to two different sets of people here.

First I want to reiterate the thanks that you expressed, Madam Secretary, to the staff. And I think not just work on the entire commission, but the efforts to try to resolve differences I thought were done in an honest and open and in a way that I deeply respect and appreciate.

And I also want to express my appreciation to the subcommittee, and particularly the co-chairs of the subcommittee, Sandy and Gail. Clearly you had an impossible mission when it comes to dealing with remedies aspects of this chapter, and I very much appreciated the openness with which you've conducted this effort.

The ability to have this discussed and have the hearings that we've had, the last two sessions, I just want to say, as I expressed my disappointment about the chapter, I want to be clear that I very much appreciate the work of the co-chairs and the subcommittee and I don't want that lost in this discussion.

So now let me turn to the merits of chapter ten. And in doing so I think I need to say just a few words about ERISA itself. All of us understand --

Secretary Shalala: Ron, I hope you can keep, everybody can keep their comments brief because we've got a lot more work to do.

Commissioner Pollack: I'm going to try to do that.

You know, as we all understand the ERISA statute not merely preempts states from establishing remedies from health plans, but it actually creates what is purported to be a remedy that from a consumer's standpoint is wholly ineffective. It only entitles one to the service denied even if that service is no longer useful, and really belies the notion of any rights because rights without any real remedies are simply not rights.

Now, one of the things that we've heard from numerous witnesses is that we've heard that there are judges all across the country exasperated by their inability to correct what they believe are clear injustices. When I conclude what I say I am going to ask the staff to circulate just to give you a sense of these are not isolated incidents. I've listed here over 20 relatively recent federal court cases which illustrate this phenomenon.

The only recourse that these judges tell us that's applicable to these injustices is amending the ERISA statute. And so let me just say that for the bad apples among HMOs the ERISA statute is the only thing that makes the National Basketball Association's treatment of Latrell Sprewell seem like harsh punishment. For recalcitrant plans ERISA offers a virtual license to wrongfully deny or delay care. Now, what does that mean in terms of what we have in the chapter that's in front of us?

I don't have any illusions, nor do I think anyone else around this table has any illusions about the commission's ability given the uniminity rule to achieve a consensus recommendation on the matter of ERISA. But after this issue has received more commission time and attention than any three issues combined, after one lengthy hearing in Chicago and two here in Washington, after thorough briefings from experts on all sides of the issue, and after we had clearly promised that we would be addressing this issue in our final report, I find it incomprehensible and inappropriate that we fail to issue a clear presentation about the alternative decisions that can be made together with their strengths and weaknesses from different perspectives.

Those alternatives range from retaining the status quo to the implementation of stringent deterrent measures to more moderate remedies. But I would suggest to you that through our silence about these alternatives, we offer only one alternative and that's the status quo. Without an honest and balanced presentation of the alternatives, including the differing views around this table about those alternatives, I cannot agree with the action we are supposed to take today.

This is, as others have said at previous meetings, a defining issue. Through some process, whether we do it jointly, separately, or through some other mechanism, we should lay out the choices as part of this report and make those choices clearly understandable for future decision makers. There is nothing mysterious about what those choices are. We know what they are. The choices have received considerable expert commentary in our proceedings. It behooves us not to shove this controversy about choices under the rug in our final report.

And let me just conclude that when it comes to these choices, silence is not an option.

Secretary Shalala: Thank you.

Other comments, other general comments on the chapter?

Tom?

Commissioner Reardon: I'll be very brief. I am disappointed that we didn't deal with the ERISA issue more explicitly. I think we do talk about the problems. But more than that, the original chapter had in it some comments about the professional liability issue, and I should say -- and the various ways of resolving that. I had thought that was going to be a consideration, at least that we were going to lay out the problems, not necessary to make recommendations or solutions.

Executive Director Corrigan: The section on page three "Reducing treatment related injuries," it begins the second paragraph, it's the letter, it's the second half of page three. It was just moved up under the whole discussion of errors.

Commissioner Reardon: Well, it was a much more detailed discussion, Janet. I know there was a page and a half in the previous one. That was my concern.

Executive Director Corrigan: Yes.

Commissioner Reardon: It laid out the various alternatives, and then it was cut down. I appreciate the fact that there is some mention.

Secretary Shalala: Okay, additional comments?

Herb?

Commissioner Pardes: Well, extending that a little further, I wonder if it would be possible, since I share Tom's concern about putting one additional thought into that section, and that is that we take note of the fact that a number of states have made some moves which I would construe in a constructive direction. And I would raise the question of our being able to say something like those should be seen as models from which a national discussion might emerge or that might be instructive for other states.

Secretary Shalala: Sandra?

Without objection, we'll have to look at the words.

Kathleen?

Commissioner Sebelius: At least in our discussion we certainly did not discuss endorsing a national no fault model. Nor did we have any testimony on what has happened to the states that have done this, have errors been reduced, or anything else. So I would be very reluctant to transfer what was attempting to be just a capture of what has happened. States have capped malpractice awards, states have capped punitive damages. That's an accurate statement, and make that into any kind of recommendation because that certainly was never discussed. We didn't have any testimony on that, we didn't have any evidence presented. And I for one would be very uncomfortable recommending any national preemption of state law in this arena.

Secretary Shalala: Herb?

Commissioner Pardes: Well, I'm not sure that we couldn't find a bridge between your comment and mine, Kathy. My main point is that one, take note of it, I think you should take note of any adverse as well as positive results of it. My only point is that one just doesn't stop and say it happened.

Secretary Shalala: Okay.

Commissioner Pardes: I'm happy with some statement which says --

Secretary Shalala: You know, let me ask the staff to draft a statement, and when we get to that section we'll take a look at some language on that. But right now I'd like some general comments on the chapter so I can start moving through.

Nan?

Commissioner Hunter: Yes, I want to make a different proposal in terms of how to resolve this issue. I mean I totally agree with what --

Secretary Shalala: Which issue are you talking about?

Commissioner Hunter: -- the issue of how the chapter should address the ERISA problem.

Secretary Shalala: Okay.

Commissioner Hunter: As Sandra said, I think what the chapter now is or could be at least potentially is basically the lowest common denominator of sort of where we all stand. And it seems to me as a process point we really have a fundamental choice. One is to go in that direction, whether it's in the form of questions or whether it's in the form of outlining what the policy possibilities are. I mean we've all spent an enormous amount of time trying to word smith this document in a way that everybody can put one toe on to this smallest piece of common ground.

And I would suggest, and that's ultimately what we're going to end up with, and I think frankly there are too many documents, and especially too many government documents, that end up with that kind of avoidance mechanism, frankly, of what is a central issue I think for most of us. And I would suggest that as an alternative we state not in neutral terms, but state in very strong terms what the positions are. I think there are fundamentally two positions, I could be wrong, but I would suggest that we state in an equal amount of space with no description about how many people agree with what position, what those arguments are. I think that's a clearer thing to do, I think it's more -- I think it's closer to taking responsibility for the kind of policy consideration that we are supposed to be doing.

And I think there are a lot of people here on both sides of this issue who have an enormous amount of expertise. And I think it's kind of sad actually to have this group of people come out with a document on this issue that none of us feels is really a quality statement of what the issues are. So that's my proposal for a way to try and deal with this.

I mean otherwise we're going into a discussion, I mean I can't live with the questions as they are now worded. We will, I'm sure, have a lot of discussion about, you know, shifting and whether this word or that phrase is value laden, and we can engage in that exercise, but I think it's important to realize we do have a choice, we could go a different route.

Secretary Shalala: Other comments?

Alan?

Commissioner Weil: When I think about on the conversations we've had, those who felt that the current system works better than any alternative that was raised, they suggested two things that made it impossible for us to come together, other than actual disagreement which I think is really what prevents us from coming together. And the two things they raised were, we don't have enough information and we don't really know what the choices are.

And this document now I think does a credible job of identifying the areas where we don't have information. It lists a series of questions that are worth examination. And I agree with Nan, I would probably present some of them differently, but at least it does do that.

But what it does nothing to help the debate is take all of the information that we gathered and convey to those who are going to have to take this the next steps, which may include doing nothing, and helping them understand what the options are.

ERISA is so easy to say to say it's so complicated no one can understand, therefore there is nothing we can do. And what I think we heard from a lot of testimony from people with very varied perspectives is that actually the number of alternatives, including doing nothing, is quite limited. And they can be distinguished from each other with some clarity, and then people who have to make decisions can pick from among them.

And it's not just that this is a soup, it's actually a puzzle, but we know what the pieces look like. And I don't see how we can take all of what we learned and not at least lay out the pieces of the puzzle. We can then say that even looking at the pieces of the puzzle there are a lot of questions we need to answer in order to put the puzzle together.

But I would go back to where Ron was and say how can we walk away from all the time we spent on this issue without at least making the questions for policy makers more clear. I don't think that is too much to ask for the process we've gone through.

Secretary Shalala: Don?

Commissioner Berwick: I was listening carefully to Nan and others, and I think I join Nan in her suggestion. I have been quite persuaded that ERISA is very complicated and that this commission hasn't done the work necessary to suggest exactly what needs to change. I have also been persuaded as far as I can be that something is wrong. And the current draft doesn't say something is wrong forcefully enough for me.

People are being denied rights that they should have. I would find those who oppose changes in ERISA more credible right now if they would, and I would urge them to do so, say yes something is wrong, but we need to address the remedies very, very carefully. I think we backed too far up in the current draft. Where possible to put the kind of language Nan has in mind in, I'd be a little more comfortable.

Let me also say I don't wish to jeopardize, nor do I think anybody else in the group does, the entire report based on this issue. I just would rather see my views reflected in that document better.

Secretary Shalala: Other comments, other general comments?

Jerry, then Kathleen?

Commissioner McEntee: Madam Secretary, we were also disappointed over the fact that the chapter really didn't more directly take on the ERISA issue. We realize it's very complicated. We realize with the process that we have adopted here in terms of basically uniminity being defined as consensus, and we all essentially agreed to that, it's very, very difficult to find that middle ground on ERISA. But at least we would like to identify, starting with Ron's position and then moving to Nan's position, and the one that Don endorsed, we would like to see ourselves identified with that, and that something on this issue, whether it's opposing views or whatever it happens to be, we just believe should be covered in this particular chapter.

We, and Bobby Georgine can attest to this, we in the AFL-CIO, all the unions, have had real difficulties, I mean we have had conflicting views on ERISA in this particular area. And I guess over the course of the last month or so we have come together basically on our differences within the federation. That's a rather defining moment for the unions and the federation. But I think if we could find that common ground within the federation, at least in the commission's report we should say more and we should at least very basically define the issues and the alternatives.

Secretary Shalala: Thank you.

Tom and then Kathleen?

Commissioner Reardon: I'm sorry --

Secretary Shalala: Kathleen?

Commissioner Sebelius: Thank you, Madam Secretary. I think again I'd like to sort of weigh in on the notion that we made another attempt to re-craft the chapter. I was struck by Secretary Shalala's description of the various accomplishments of this commission, and her statement that there were some issues contentious enough that what we did was outline the terms of the debate.

And I for one don't feel chapter ten adequately outlines the terms of the debate of what will be on the table for Congress to deal with and ERISA. I don't believe that we will reach consensus on the goal of that debate. And I do believe that there are very strong and compelling arguments that really are premised on the fact that the debate should not begin. And that's, I guess, the frustration that we found in the committee.

The status quo position on ERISA really believes that having any debate in a legislative arena is too dangerous because it will open Pandora's Box and somehow everything will be lost. And so that I think we found ourselves doing as a subcommittee often was not even being able to articulate questions clearly because those questions led to a debate which should not start. And I think unfortunately that is what's reflected in this chapter.

I do think that we were able to put on the table other contentious issues, the issue of how to deal with the uninsured, the issue of lifetime caps. We were able to say at various points in this document, we couldn't reach agreement on this, but this is a serious issue, it needs to be addressed, we can't walk away from the table without recognizing that there are Americans who are uninsured.

We don't do that in ERISA. And I guess having an attempt to say this is an issue we could not reach consensus in our group about, but here are the outlines of the debate, here are the positions in the debate, and then call for a national dialogue I think would be very helpful.

Secretary Shalala: Okay, thank you.

I've asked people to start drafting something that might reflect this debate so that we can at least have an open discussion of something that I think probably would substitute, something a little stronger that would substitute for the section called "Issues for consideration," which is really where people are focused, but that's much too weak of a set of words to really point out both what the points of view are as well as what the issues are for the debate.

And let me have that drafting done, and meanwhile I want to collect any other general comments on the chapter as well as I'm going to move through the chapter and get some specific comments with the exception of that focus.

Randy?

(Whereupon, microphone malfunctions.)

Commissioner MacDonald: This thing is not working today. I remember this feeling, well it was tenth grade English class and Ms. Coocher called on me and I felt like all eyes were focused on me, and I guess that's a little bit of what's happening today because it's real obvious to me that I'm perceived as being on the other side, and that's probably a fair perception.

Secretary Shalala: But no one has ever perceived you as being on the other side of an open debate and laying out the principles that we're doing.

(Whereupon, microphone malfunctions.)

Commissioner MacDonald: I will be just a tad longer than perhaps you want to me to be, and I don't mean to be, but I'll try to speed it up.

But let me tell you one of the things that I have felt that has worked very well in this commission is the sense of candor and honesty. And part of what is driving me to worry about the definitiveness of what we put in this chapter is by some unknown ability to take a position that others may use in a stronger term to push through the political process.

Where I come from is that in my mind what we should be focusing on all the time is the outcomes. That's what this commission was all about, is the outcome of the health care system, and that we should do everything in our power to stay out of the political process. Because we are not serving, if you will, in my mind at least, and maybe I am naive, but we are not serving the political process, we're serving our fellow citizens and we're trying to improve a health care system that by the way is pretty damn good already and we're just trying to make it better.

What I worry about is, is that if we somehow put in a document in a very strong way, and some people have expressed it that way, "in strong terms" was an expression, that we will create a cost or an unattended consequence that none of us understand. Let me give you an example. If we somehow endorse the concept of a remedy, there is a couple of choices that will occur, and I will use my company as one. That cost somewhere along the line has to be passed on. It's passed on in this instance to the employer. I have a couple of ways of looking at it. I can eat that cost, I can pass it on to the employee, I can pass it on to the produce or the service we provide, or I can eliminate coverage. That's the last thing this commission wants to do is to eliminate coverage. And I'm not threatening that, I'm just saying that's a potential alternative, we talk about alternatives.

There is another way, if we pass it on to the employee, the employee then has a decision to make, whether they can afford it. And we know by testimony that some employees who have health care coverage are rejecting health care coverage are rejecting health care coverage because they don't want to pay for it.

So what I'm trying to say to the commissioners here is that let's be very careful. I mean I can sense where everybody is coming from, and I will try to your point, Madam Secretary, to create a dialogue, but the issue of the strong terms and the strong positions I think is very dangerous. If I can paraphrase Ron Pollack when he said a right without a remedy is no right, I would suggest to you that a right without coverage needs no remedy, and that's what I'm really afraid of.

Secretary Shalala: That's a fair enough point. And let's see, I think the point that was being made is that to strengthen this chapter we may have to be clearer about what's in the arena for the broader discussion that needs to take place in this country, and let's see if we can get some language that will accommodate that and let's see if we can work through it.

Don?

Commissioner Berwick: Madam Chair, may I ask Randy a question just in the spirit of dialogue?

Randy, help me out here. I really have heard the level of concern about what might be torn apart by mistake if we get too invasive here. What I haven't heard is a clear statement from those who are most worried about that, about whether there is a problem. I mean it would seem to me at a minimum our report and the commission as a whole ought to be able to say that something really is a problem here. We don't know what to do about it, and we've got to be very, very careful. I don't want to put you too much on the spot, but let me do it. Well, please I respect your point of view completely, Randy, and you have been a great colleague, but don't we have a problem here and shouldn't we as a country really take a look at this and be very cautious and listen carefully to all sides, but can't we at least say something needs to be worked on here other than just putting a bunch of interrogatives out?

Commissioner MacDonald: I keep pressing this. This is broke, whoever is running it.

(Whereupon, microphone malfunctions.)

Secretary Shalala: What control she's got.

Commissioner MacDonald: You know, one of the things that I would try to do, Don, in particular is quite often when I look at, you know, my family and I would say to myself, you know, what would happen if it happened to me because I have to make those decisions day in and day out. I can't, I'm not a naive man, nor am I going to not be very credible and say there is no problem, that would be a lie. I mean we've had testimony that says there's problems. What I'm intellectually trying to understand is, if I solve one problem, am I creating more problems.

And that's really all this is about, is that if I'm in the business of providing health care coverage to a group of employees, whether I'm negotiating it with the unions or I'm just doing it because it's a competitive issue that I do, I want to kind of understand that where does my liability end. I mean, you know, there is a debate going on right now. I mean it sounds warped, but there is a debate going on right now within the halls of many circles that say where -- you know, it's like, if I provide single coverage and I provide family coverage and family coverage costs me $7,000.00 and single coverage costs me $5,000.00, should I really be paying that extra $2,000.00 or should I just be giving everybody $5,000.00. The whole issue comes down to is, where does my liability stop?

And if we start dealing with the issue of remedies in a way that begins to push liability to the employer community, what I'm saying to my fellow commissioners is look out. We may be creating yet -- we may be back here a year from now dealing with a bigger problem. That's all. And I can't predict that, Don. I'm just trying to say to you, yes there's got to be problems. We have (x) millions of Americans, there's going to be statistically problems. I just don't know how big one is to be solved versus the other one that we may create.

Secretary Shalala: Secretary Herman?

Secretary Herman: Picking up on what Don just said, Randy, I just want to push for some additional clarification here. Because as I listen to the discussion what I'm hearing is basically a threshold acknowledgement of the issue as opposed to perhaps, as I've listened to what you're saying and obviously I'm very much aware of the concerns on the employer's side here as well as what the unions have struggled through, you really are further down the road in terms of solutions and issues and what the current debate is around what we ought to be doing.

And I hear the commission asking for threshold acknowledgement as opposed to moving the ball further down the court, if you will, to be much more hands-on in terms of what we do about the problem. So I'm hearing whether we acknowledge as opposed to what we do. That's really the interpretation of what I hear is taking place around the table. And I'm asking basically for clarification from you just in terms of what I'm hearing.

Commissioner MacDonald: I think that's, I think that's a fair characterization. But again I just want to keep nailing the point that we've got to be careful in the use of our English language of how we indict what may be indeed going on. I think that we get too often hung up with focusing on the negative and not having some level of balance about what is also right. And, you know, if you can --

(Whereupon, microphone malfunctioned.)

Secretary Shalala: Apparently we --

Commissioner MacDonald: I'm troubled because it can go beyond that. I mean we're focusing on remedies right now, but ERISA even goes beyond that.

Secretary Herman: Yes, I know.

Commissioner MacDonald: And that's the other concern. Is that I am faced, and I'm not going to get into this debate, but I am faced with issues where right now I am charged with whether it be city, state ordinances which are telling me now how to manage my health care system, and I do say that I am not obligated to follow that because I'm under ERISA.

If I have to pay attention in a major corporation to all of the liabilities that I may ultimately have state by state, I'm out of the business. I am not going to put this corporation or any corporation that I represent into a situation where that the value of the corporation is at risk with the liability that I have going forward, and that's what the issue is here.

And then when you make it from a business case, you then have to step back and say what does it do for the rest of the country, what does it do for the employees including my family because I too have a selfless interest here. And that's the emotion that I'm trying to draw out here. I just want to make sure that we have done a very good job, especially in the Bill of Rights, of trying to find balance, and we had enormous dialogue where we disagreed, but we never made an indicting comment in my mind in the Bill of Rights.

And that's what I'm worried that will come out here with ERISA, is that we overly indict a process that fundamentally has worked, fundamentally is allowed innovation, and we could lose all that in one fell swoop because we don't know what we're saying.

Secretary Shalala: Okay, let me -- I happen to think after listening to all this discussion that we actually can accommodate everybody's views and move to a much stronger statement. So I'm going to call a break for ten minutes because there are a number of people drafting, and have us all come back. When we come back I want final -- we're going to have some language for us to look at, I want final comments on chapter ten.

And if there is anything else on the previous chapters that isn't just an editing correction, would you tell Janet now because I'd like to sort of move through those fairly quickly. If you've got editing comments, I assume you've given them to her already. If there is some substantive thing that they haven't drafted that you thought were going to be in another chapter, tell her now so I can go to specific people.

(Whereupon, at 11:16 a.m., a recess until 11:45 a.m.)

Consideration of the Final Report

Secretary Shalala: If I can, while they're finishing up, let me see if I can gather from the commissioners anything other than editing, anything that wasn't included in some of the other chapters and let me start with chapter one, and see if there are any comment on chapter one that the whole groups needs to hear.

Marta?

Commissioner Prado: I just want to ask you a question. If we just have minor --

Secretary Shalala: Then just give them to Janet.

Commissioner Prado: -- just give them to Janet.

Secretary Shalala: Just give them to the staff. For the most part, and I've given them my minor comments, anything non substantive, if there is something that was left out, actually a whole policy are that you think we've agreed on, do bring it up here, but any comments on chapter one.

Paul?

Commissioner Montrone: Yes. Chapter one, I don't have a lot of comments on most of the chapters, but I do on this one. If you'll see back and look at the chapter as a whole, I question whether we're really talking about the state of health care quality and how good is care.

This is a chapter that is focused on the problems in our health care system by and large. The last time we had a discussion on this subject at the last meeting it was oriented around the executive summary which opened up and there were a number of us that thought it was really not complimentary enough about our health care system and the people working in this health care system and the accomplishments, and there was a request to make it more balanced.

And in the executive summary, in the first four or five paragraphs, it is that balance came into it. I kind of assumed that, since that was a summary of what was going to follow, that that type of balance would show up in this chapter, and it hasn't. I mean going through the first opening statement of this chapter for example, it says "While most Americans receive high quality health care from skilled practitioners, too many patients receive sub standard care." So we are disposing in a clause of the high quality of our health care and we're focused on too many patients received sub standard care.

I don't think short of, you know, a major overhaul, which I'm not suggesting, I'm just wondering whether we should at a minimum change the title of this chapter. It's a title that Morris says that what we're talking about here are the problems of the health care system.

Secretary Shalala: I need Janet to respond to that because they did do a rewrite of this chapter.

And can you respond to that?

Executive Director Corrigan: I'm sorry?

Secretary Shalala: Why don't you repeat your question, Paul. The point was that we had had some discussion at the last meeting, in fact pretty extensive, about chapter one and about making sure that we talked about the positives of the health care system. We did change the executive summary.

But Paul's point is that chapter one doesn't look like it was changed as extensively, and he's asking a question about whether the title is now accurate.

Executive Director Corrigan: Your suggestion is that we change the title --

Commissioner Montrone: Yes, care. If you read through this care is pretty horrible because we've focused on the problems. I'm not suggesting -- and this commission has spent most of the time focusing on the problems. So I'm suggesting maybe we change the title.

Secretary Shalala: Tom?

Commissioner Reardon: Thank you, Paul. I'm the one that brought up the issue on the executive summary last time about the tenor of the language which was changed I think is much more -- you know, it states there are problems, but we have a good system, let's improve it. That's what you're referring to in chapter one.

Secretary Shalala: I actually was opposed to changing the title, my reaction was sort of that we should actually build up the first page so that it is more positive about the context as opposed to changing the title. It seemed to me that we just needed it to be stronger. We sort of did it in a couple of sentences as opposed to a number of paragraphs.

Commissioner Montrone: Yes, I think if somebody could take a look at that and beef it up.

Secretary Shalala: Just take another look at --

Commissioner Montrone: And we have two sentences, if you get out of the Italicized. You know, the first two sentences --

Secretary Shalala: Every day --

Commissioner Montrone: -- say something about it and then we go right into the problem. The third sentence gets into concerns.

Secretary Shalala: All right, let's take that.

Any other comments on chapter one that are not editorial?

If not, we'll move to chapter two and see if there are general comments. I know some of you have given some specific comments on chapter two. Are there any other questions about chapter two, anything that wasn't included in chapter two that you thought that we had discussed?

If not, we'll move to chapter -- go ahead, Paul.

Commissioner Montrone: I do have one item. We do have a discussion in here about cost. We've had ongoing discussion throughout this whole document about the fact that if you bump costs up, you lose people. And I don't know that that is actually in the document anywhere, and I'm just wondering if we should say that somewhere. And if it's going to be said, maybe it belongs right here where it says where we talk about costs on page two. Can somebody --

Secretary Shalala: I think that --

Commissioner Montrone: -- indicate where it is.

Secretary Shalala: -- we've said two things. Number one, sometimes when you bump up costs, you save money. So there are both sides. You may have an increase in costs on one side, we said that in the consumer Bill of Rights, that there are aspects of the patient Bill of Rights where it may increase costs to provide certain kinds of information, but on the other hand you save money on the other side. So I think what you want is a balance statement in here and we should just make sure that in our re-read of this chapter that we have made, or of all the chapters, that we have made balance statements about that.

Anything else, Paul, on chapter --

Commissioner Pollack: Can I just build on what Paul was saying?

Secretary Shalala: Yes, right.

Commissioner Pollack: I too actually had a concern about that particular part of the chapter on page two. Change has been made and there is some improvement. I'm not sure I feel comfortable with how adequately it's improved. In that first -- in the second paragraph, the paragraph that begins both the number and share of those --

Secretary Shalala: Tell us what page you're talking about?

Commissioner Pollack: I'm on page two. Before there was a comment something along the line that people didn't choose to take health insurance, and that's stricken. And I thought we had some agreement, it's certainly been raised a bunch of times, that cost was a serious reason as to why people didn't opt to accept employer-provided coverage. And here we're far more neutral at this point where we say although the reasons for employees declining an offer of insurance are not well established. I'd like to say something a little stronger about cost being a significant factor at a minimum as to why it's not selected.

Secretary Shalala: Well, it certainly is a -- we'll make a note of that, we'll make a note of that. I think the point is -- well, we can figure out how to do that.

Chapter two --

Commissioner Pollack: I did have one more comment, I'm sorry.

Secretary Shalala: Okay.

Commissioner Pollack: And that is that, and I brought this up to Ann, so maybe it's resolved, but this is on the issue of managed care, and we did beef up our discussion of managed care in the chapter. The thing that I don't see anywhere in here, and it came out in the McGlenn report, was, you know, what I would call the hope of managed care. I mean we do have an enormous number of people in managed care. We kind of treat it like it's neutral. And the whole idea that, you know, managed care, if done well, really gives us a lot of optimism about how we can improve our quality. That particular thesis I don't see in here anywhere.

Executive Director Corrigan: Well, I guess only because this is a -- this was intended to be purely a review of the evidence that we have. It wasn't attempting to assert specific positions or --

Secretary Shalala: About any --

Executive Director Corrigan: -- about any aspect of the system --

Secretary Shalala: -- particularly organized system. It was just summing what literature we have at this moment.

Executive Director Corrigan: Well, my recollection of the literature, and there are some specific references here and there where data is presented that managed care data usually is better than the average for all Americans.

Secretary Shalala: The data?

Commissioner Montrone: Yes. You have --

Secretary Shalala: The data or the outcomes?

Commissioner Montrone: The outcomes of -- like you have some statements in here about certain prevention techniques, and you'll say, you know, like certain tests are being done, the average of the nation is 67 percent and under managed care it's 72 percent.

Secretary Shalala: That's actually a more subtle point of recognizing within the literature of where there are differences. And I thought we made reference to that actually.

Executive Director Corrigan: I think we do in the --

Commissioner Montrone: We do, but we never take that together and say look, you know, this gives us a lot of hope about managed care. If it's done well, this really can improve, help improve quality. It seems to me that that's what the data suggests. Maybe there is disagreement on that point, but I didn't see it.

Executive Director Corrigan: Well, the data on quality of care suggests that quality is about equal in various managed care settings to that which is in the traditional indemnity. I mean you are correct that there are some data to indicate that in the area of preventive services managed care appears to be doing a bit better. That's basically what we can say based on the evidence. Okay, we can make that clearer.

Secretary Shalala: This is an evidence-based report, so if we need to make it clearer, just make it clearer.

Herb, we're still on chapter two?

Commissioner Pardes: I just want to make a comment, if one starts toning this the other way, I am not so supportive of that. I'm no so persuaded about the optimism we have as to where we're going with our health system --

Secretary Shalala: I think that that was not the conclusion. The conclusion was to keep to the evidence, and that's all we're doing here.

Any more comments on chapter two?

Commissioner Pollack: Yes.

Secretary Shalala: Yes, Ron.

Commissioner Pollack: I have one more comment, and I raised this comment last time. I thought it was going to get corrected. In the bottom of page two in the section "Continuing concern about the cost of health care," and then continuing on the next page on health insurance premiums, we cite that health care costs have decelerated and premiums have decelerated. But I thought we were going to say something that there is concern that this may not be a long term phenomenon, and indeed we're hearing evidence, Ken Thorpe had presented a lengthy paper on this question and others have as well.

Secretary Shalala: Go ahead.

Executive Director Corrigan: We added on page three the first paragraph on health insurance premiums, we added in the sentence "In 1997 premiums for employers with 200 or more workers increased by 2.1 percent. The third consecutive year that a cost, the cost of employer based health insurance rose, lessening the overall rate of inflation and worker's earnings. However, it was also the first time in eight years that the percentage increase in health plan premiums was not lessened out of the previous year."

Commissioner Pollack: I noted that.

Executive Director Corrigan: We tried to get the most recent data, evidence, as to what was happening. What we have not done in this chapter is to put out people's projections of what's going to happen. We have stuck purely to the evidence. And I realize that there are some that are predicting that they're going back up, but that sort of moves us into an area that we were trying to avoid with this chapter. We tried to get the most recent evidence that we could, but until they actually do go up I think we're sort of crossing a line here if we start taking people's predictions.

Commissioner Pollack: Well, I guess I just want to just express why I raised this issue. Many people have questioned whether some of the savings that have been achieved are one time only savings, and I mean that's common in the literature. And my concern about not recognizing that that may in fact be true, and I'm not saying that it is true, but that it may in fact be true, I think would lead someone to conclude two years from now when the cost increases do occur, people will say ah-hah the reason they occurred is because, you know, some folks established regulations that saddled the industry with higher costs. And I don't believe that that, you know, that would be accurate.

Executive Director Corrigan: If we could just let Ann, she has an important I think. She was the one who reviewed a lot of this.

Commissioner Page: The '97 Peat Marwick data began with a preface from Peat Marwick that in spite of the predictions in 1996 that premium costs were going to rise greatly in '97, but that was not the case. And that predictions of '96 were not borne out by the facts in '97.

We also attempted to be cautious in this whole section because of the comment that was made by many commissioners at the last meeting, that we be careful how we portray trends and that sometimes a one year increase or a one year decrease was not a trend, but a blip, and so we did try to just stick to the evidence in where we are rather than where we might be.

Executive Director Corrigan: And what we had tried to do here, Ron, was to not try to characterize these data or go into extensive discussion about whether it's a one-time phenomenon or it is a trend or whatever, it was purely to try to state in as neutral terms as possible what we know.

Commissioner Pollack: All right. And I thought the way to achieve that is to say some, you know, is that some projections indicate that this may not be a continuing trend and that costs may -- something along that line, that doesn't say anything definitive, but makes clear that a number of researchers have projected that they will increase.

Secretary Shalala: I think that Ron has got a point because almost every analysis says something near that, and that is there is no consensus, but everybody is watching it, and that if you don't put in that extra sentence, it looks flat as if you've just taken a snapshot as opposed to understanding that the system is still shifting under our feet, and I think there is a way of -- let us look at that. And I'll look at it myself, Ron, as we're finalizing it.

Commissioner Pollack: All right, okay.

Secretary Shalala: Anything else on that chapter? Does anyone else have anything on that chapter?

I'd like to move to chapter three for any final comments. If they're just editing comments, please hand them in. I'm most concerned about whether you think the chapter reflects the final reading that we had on it.

Alan?

Executive Director Corrigan: I've got Alan's comments.

Secretary Shalala: Chapter four?

Executive Director Corrigan: On chapter four, page 15 the top paragraph that begins with "Similarly" --

Secretary Shalala: Do you want to put your mic on.

Executive Director Corrigan: Sorry. Page 15 of chapter four, the very first paragraph that begins "Similarly there are limits," Alan --

Commissioner Weil: Janet, just to note, I gave you the blacklined version on people, what they have in their books. It's the top of page 15.

Executive Director Corrigan: Top of page 15?

Commissioner Weil: So they'll know where you're talking about.

Executive Director Corrigan: Okay, great.

This paragraph ends with the sentence "Given that science cannot guarantee that risk adjustment will be perfect decisions about risk adjustment will inevitably engender controversy with legitimate arguments for and against using methods with inevitable shortcomings."

Alan is suggesting the sentence "Despite these limitations the commission recommends that," gee whiz, something or other "testing and implementation of risk adjustment proceed as rapidly as possible."

Secretary Shalala: Alan, please?

Commissioner Weil: Sorry, I thought this fell in the technical category. This is a sentence that we agreed to last meeting that did not appear. On the blacklined version it's on the top of page 15 on what is in your book, it's the last paragraph on 14. And after that paragraph ends we agree to say, this is about risk adjustment, "Despite these limitations the commission recommends that development, testing and implementation of risk adjustment proceed as rapidly as possible." I think we agreed to that and it's just now being --

Secretary Shalala: Without objection.

Anything else on chapter four?

If not, we'll move to chapter five "Creating public/private partnerships."

Yes, Paul?

Commissioner Montrone: On page four we talk about the consumer Bill of Rights and Responsibilities, and we talk about strengthening the capacity of consumers and so forth, but we never talk about their responsibilities in that paragraph.

Secretary Herman: Say that again, Paul?

Commissioner Montrone: We don't talk about the responsibilities of consumers, and that might be a nice place to put it.

Secretary Shalala: Okay. Without objection.

Commissioner Montrone: And also on page seven I have one thing I thought would get dropped out, which it didn't, and we talk about the advisory counsel structure. And on the bottom of page seven we talk about private sector widespread adoption of its products and recommendations, and I didn't know what we meant by its products. It seemed like a strange choice of words, but maybe that's part of the art.

Secretary Shalala: Is he looking at another -- what, page seven, okay, toward the bottom.

Commissioner Montrone: At the bottom of the page.

Secretary Shalala: Okay.

Executive Director Corrigan: Well, one of it's products would be the aims for improvement. That would be a product, and specific goals and objectives.

Secretary Shalala: What's the difference between a product and a recommendation?

Executive Director Corrigan: Well, if you think of something only -- it probably isn't that significant, but if you think of something like the Healthy People 2000 document that, I guess it's a set of recommendations, it's also sort of a product, we can just leave it recommendations rather than --

Secretary Shalala: Yes, the word "product" is unusual in context.

Executive Director Corrigan: -- the word "product," okay.

Secretary Shalala: Okay, anything else on chapter five?

Don?

Commissioner Berwick: Madam Chair, could I just ask for some advice or comment from somebody on the size of the counsel we're proposing. As we've added people it's gotten to 16 to 20, and I just wonder if we have recommended something a bid unwieldy in size.

Executive Director Corrigan: I can tell you where it came from. It wasn't as a result of a detailed analysis. It basically was the size of PPRC and PROPAC in their earlier days. They did grow over time. It's probably a $10-$12 million commission. It was just sort of a rough estimate looking at others, other types of commissions, executive advisory councils of sorts. It was not based on a very detailed analysis of the work, and that would have to be done before it moved forward.

Secretary Shalala: Given the size of this one, it looked like a piece of cake to me.

Commissioner Berwick: Only if you chair it.

Secretary Shalala: Sylvia, we're on chapter five.

Commissioner Drew Ivie: On page ten I would hope that the consumer and patient representation would not be limited exclusively to organizations representing consumers and patients.

Secretary Shalala: Yes, I think we actually had made the point the last time, individuals and organizations, right. You had actually made that point before, so we need to clean that up.

Chapter six. Okay, Chapter six. Comments?

Paul?

Commissioner Montrone: Yes, there was a sentence added to the summary in the front, which is a summary of the text, and when I saw it added, I figured well we added a whole section. That's "Seeking opportunities for consumer involvement in governance and oversight." So we've got something about consumer getting involved in governance and oversight, and then when I flip through the text --

Secretary Shalala: Where, give us a page?

Commissioner Montrone: On the first page, on the summary at the top there, Italicized summary.

Secretary Shalala: Okay.

Commissioner Montrone: Third line from the bottom "Consumers require help in making informed health care decisions, seeking opportunities for consumer involvement in governance and oversight."

Secretary Shalala: I don't know what you're looking at. We're on chapter six.

Commissioner Montrone: Oh, sorry, sorry, sorry. Six, I've finished with six already.

Secretary Shalala: Okay, you finished six, all right. Paul has finished six. Does anyone else comments on chapter six? All right. Chapter six, any other comments on chapter six?

Without objection we'll move to chapter seven.

Commissioner Montrone: All right.

Secretary Shalala: Do we have anything else on six? If not, we'll move to chapter seven.

Paul?

Commissioner Montrone: Okay, I made my statement.

Secretary Shalala: Okay, we're on page one, the Italicized summary at the top.

Janet?

Executive Director Corrigan: The sentence you're talking about is "Consumers" --

Commissioner Montrone: We're strengthening the hand of consumers, okay. We want to strengthen then to "Seek opportunities for consumer involvement in governance and oversight," it was an addition.

By the way I do want to thank the staff for the redlined version of this document. It really made it a lot easier to find these changes.

But there was one. This was an addition from the last time.

Secretary Shalala: "Seeking opportunities for consumer involvement in governance and oversight."

Commissioner Montrone: Yes, there's nothing in the text below that talks about this.

Executive Director Corrigan: It was a recommendation that was agreed to at the last meeting, to mention something about governance and oversight. It was not something that was considered by the subcommittee or reflected in the document, but it was agreed to at the last meeting that there should be some mention of it.

Commissioner Montrone: But this is a summary of the document. If we're going to mention it, then we should explain what we mean by that. And I'd like somebody to please explain what we mean by that?

Secretary Shalala: Peter?

Commissioner Thomas: I think I made the suggestion, well I know I made the suggestion that we include consumer governance and opportunities for consumers to become in the government structures of health plans and advisory boards and the decision makers in health care, and to have consumer involvement. And it struck me that in reading the chapter "Strengthening the hand of consumers" to not mention anything about that issue was a real oversight in my view. So I suggested that we include that at the last meeting.

Now, there was some language in the chapter that talked about that previous to my statement. And yet as I go back and look at it I can't find it. There was a statement or two in the chapter and I can't now find it, but I've been talking with Ann about this.

Secretary Shalala: Well, Paul is actually right. If we refer to it there, we've got to have a couple of sentences. We have to figure out a way to put a couple of non controversial sentences that doesn't lock in the --

Commissioner Thomas: Well --

Secretary Shalala: -- Peter?

Commissioner Thomas: -- I suggested a sentence or two, but Ann was informing me that because the subcommittee had not really looked at the issue at all in depth, that it was kind of difficult to then incorporate it at this time. And I don't want to put Ann on the spot certainly, but I'm hoping if we are going to have it in the summary, I would love to see some language in chapter that elaborates on it.

Secretary Shalala: It seems to me if the full commission agreed to it in the summary, then we can have two or three sentences that explain it in the text. So if the commission agreed to it in the summary, the full commission agreed to it in the summary, then we've got to find two or three sentences that we can incorporate into something else without going beyond what the full commission has agreed to.

Executive Director Corrigan: We can do that, we'll come up with a sentence or two --

Commissioner Thomas: Great.

Executive Director Corrigan: -- and find a place to insert it.

Commissioner Thomas: Thank you.

Secretary Shalala: Paul?

Commissioner Montrone: I think, I don't really recall the debate on that, I'm sure I don't remember a debate. I think Peter probably suggested it and it sounded fairly innocuous. But as I read it, this is not an innocuous statement here, I mean so I think that we should really --

Secretary Shalala: That is correct.

Commissioner Montrone: -- this is a powerful statement, so I think we should really focus on it.

Commissioner Thomas: Where does that leave us, you want to focus on it?

Commissioner Montrone: All right, if somebody wants to include it, they should draft some language.

Secretary Shalala: The sentence doesn't say, the sentence says "Seeking opportunities for consumer involvement," it doesn't say, it doesn't lock it in. It says "Seeking opportunities," which means that --

Commissioner Montrone: Okay, but the commission, this is a commission recommendation we're talking about.

Secretary Shalala: That's correct.

Commissioner Montrone: We're recommending that we "Seek opportunities for consumer involvement in governance and oversight."

Secretary Shalala: That's correct.

Commissioner Montrone: Well, what do we mean by that? Does that mean --

Executive Director Corrigan: It isn't a recommendation actually, it's above the recommendations and maybe that's the problem is that it's in that front end section, maybe it's something that needs to be woven into the text. We didn't mean to elevate it to a level of a recommendation.

Commissioner Montrone: It says "The commission recommends" in the summary, and most people are not going to read the text, they're going to read the summary. "Recommend several steps to strengthen consumer's ability to fulfill their roles and responsibilities. These include," so it is a recommendation.

Executive Director Corrigan: You're correct, and that's an error on our part. It should not be in that sentence because it isn't reflected in the recommendations. So basically I guess the question is whether you want something reflected about the desirability of having consumer involvement in governance and oversight and, if so, where.

Secretary Shalala: Peter?

Commissioner Thomas: I don't consider it an error. When I offered it at the last meeting I meant it to be a recommendation just like the rest of the statements are in that chapter. I think it's a critical piece to strengthening the hand of consumers, and it goes right in line with what the chapter is all about.

And what I'm suggesting is not that you have any kind of a mandate or any kind of directive that consumers be involved on anything, but it is a opportunity to seek inclusion of consumers on advisory boards, on internal review panels, on boards of directors, on policy making bodies, on all different types of decision making bodies that take place in health care. And it's an opportunity for consumers to get real involved in that.

Secretary Shalala: Okay, Tom?

Commissioner Reardon: And I'm not disagreeing with Peter, but what I'm saying if you would move that statement up to the sentence just prior to "The commission recommends," where they say "Stronger consumers also are better able to carry out their dual roles and responsibilities as -- and patient. One way may be as seeking opportunities for consumer involvement," etcetera. That would eliminate having to rewrite the text of the chapter and yet still include that statement.

Secretary Shalala: Peter?

Commissioner Thomas: Yes, it would. The question is whether it should be a recommendation. I'd like to see what other people think about having it included as a recommendation before I suggest that that's fine.

Secretary Shalala: Phil?

Commissioner Nudelman: Well, I also independently wrote some input on this particular topic because coming from an all consumer governed organization, I can't go home unless something is in here like this. I think it should be a recommendation.

Also, there is a comment on page seven in the first paragraph that says "A strong consumer voice also is needed in the government structure" --

Commissioner Pardes: What paragraph?

Commissioner Nudelman: Top, first paragraph. "Needed in the government structure of efforts to collect and disseminate information on quality," which also I think refers back to the individual or the recommendation. But I would love to see an added sentence or two that really talks about the values.

Secretary Shalala: I think that we agreed to this where it is, and that the only addition that's in order is whether we clarify it in the text so that we actually make sure that we refer to it further along in the text. People had plenty of opportunity to -- it was not innocuous in the way that it was raised, and there actually was some discussion on it. So I think that you're just going to have to find places within the text to refer to it. And it is not locking anything else.

Peter was very specific in his discussion. He was talking about seeking opportunities, not mandating on specific governance boards, and that's the way it ought to be treated in the text. It was not a mandate, it was seeking opportunities, and he was very clear when he made the presentation, that it was looking for opportunities to include consumers.

Kathleen?

Commissioner Sebelius: And along those lines one possibility is on page four we talk about, in that first paragraph with reference to the whole Consumer Bill of Rights, the need for consumers to adopt a more active role with respect to their health care and we outline a whole series of ways that that can be done. Adding a sentence or two about the possibilities for inclusion in governance and oversight would be real appropriate I think in that paragraph.

Secretary Shalala: Wherever we put it in, it should not expand what was the intent of the full commission which is seeking opportunities, not are we reopening any major policy debates about what we've included in as recommendations. We're simply clarifying or adding to the language. So the staff is instructed not to go beyond what the commission has agreed to, and that is not a mandate, but seeking opportunities and to add language that is consistent with that.

I'd like to, if there is nothing else on chapter eight, I'd like to move to, or rather chapter seven, I'd like to move to chapter eight. Anything on chapter eight?

If not, we'll move to chapter nine. Again we're looking for things that we've agreed to that have not been included or the kind of thing that we saw before where we would need to add some language that's consistent with what we've agreed to. We're not reopening any policy debates.

Chapter ten, oh forget about chapter ten. We're coming back to chapter ten. Chapter 11.

Commissioner Montrone: Wait a minute, hold everything, hold everything.

Secretary Shalala: Yes, chapter ten, that's --

Commissioner Montrone: I'm still on chapter nine. Can I make a comment on chapter nine?

Secretary Shalala: A quick comment.

Commissioner Montrone: Quick, very quick, very quick.

Secretary Shalala: Okay.

Commissioner Montrone: On page four, this has to do with implementing the Consumer Bill of Rights of all things. We have this statement in the first paragraph after we say we're not taking a position that "It is reasonable to expect that they," meaning the private organizations, etcetera "could develop effective area of accountability," and then in the next paragraph we say "The commission encourages all health plans providers to move rapidly in implementing." Now, those two statements seem inconsistent to me, and I don't know why we kind of whimped out in the first statement, and why didn't we just -- I didn't realize that we didn't agree that there should be voluntary compliance, I thought the debate was over legislation.

Executive Director Corrigan: No.

Commissioner Montrone: Can you explain that then, that inconsistency there?

Executive Director Corrigan: I don't think it is inconsistent. My understanding is that there was an agreement on whether it should be voluntary or legally enforceable standards that's an issue that -- basically the commission's position is that it should be implemented, it can be implemented through a variety of different means, and it should be available and applied to all Americans. But there was not a specific position taken on whether the Bill of Rights should be embodied in legislation or implemented through voluntary means. But an encouragement certainly to move forward with whatever means we have available.

Secretary Shalala: Chapter 11.

Commissioner Montrone: Sorry, sorry. In the first, chapter 11, fourth line, the word "extensive."

Secretary Shalala: Chapter 11, page?

Commissioner Montrone: Page one, I'm sorry, page one in the summary.

Secretary Shalala: Page one, fourth line.

Commissioner Montrone: The word "extensive."

Secretary Shalala: I'd just take it out actually, I'd take it out.

Anything else in chapter 11? Without objection we'll move to chapter 12.

Anything in chapter 12? We do have some editing and some people have caught some typos and stuff, so just assume all that's been done.

Chapter 12?

Chapter 13? Any other comments on chapter 13? Anyone that dares make a comment on chapter 13?

Chapter 14?

Commissioner Montrone: I have a comment on chapter 14. On chapter 14, can I go ahead? Who is chairing this?

Secretary Shalala: Chapter 14?

Commissioner Montrone: Chapter 14, yes. We expanded on this year 2000 problem on page six, and I'm just wondering, and I forget who brought this up, but it was an excellent point that, you know, one of the real exposures, we have a lot of our portions of health care organizations are not really working on this problem. I'm just wondering whether we should bring that up into the summary. The last sentence perhaps --

Secretary Shalala: Say that again, say it again?

Commissioner Montrone: Page six, second paragraph, last sentence which was this whole area has been developed in the last draft "Perhaps even more disturbing however is that many small organizations that have not yet begun year 2000 planning may be unaware of how vulnerable their current systems are."

Secretary Shalala: Yes, that's fine. Can do.

Anything else in chapter 14? Chapter 14, any other questions?

If not, we've finished all the chapters except for chapter ten, and we're going to go to lunch and come back and deal with chapter ten.

Without objection we'll adjourn for an hour?

Secretary Herman: 45 minutes.

Secretary Shalala: 45 minutes actually, and then we're going to come back and we're going to do chapter ten, and we're going to have everyone's final comments.

(Whereupon, at 12:22 p.m, the meeting was adjourned and will reconvene at 1:11 p.m.)

Afternoon Session

(1:11 p.m.)

Final Consideration of the Executive Summary and Chapter Ten

Secretary Shalala: I think what I'll do is move to the Executive Summary to see whether -- it's the one part of the report that we didn't agree on. I also want to point out to you that the Consumer Bill of Rights that we've already approved will be included as part of the printed document.

I think it was the Chair's view that the document ought to be stand alone, and even though it adds a number of pages that we've already put out in an interim report, it seems to me that when people ask about the Commission's report they are going to want the whole thing, not just what we've done today.

So, we will be taking the 70 pages that are in the interim report and printing that with the rest of this document, so that future readers will have a single document to work from.

But, let's look at the Executive Summary and see if anyone has any comments.

Governor Ray, you had a comment on the second paragraph.

Commissioner Ray: Well, I just think that we start now with a statement that makes it appear that the health care system is running along smoothly and everybody is doing the right thing.

I know why we put it in there, and I think it's smart and wise for us to not criticize everybody in the health care business, but it isn't exactly what makes you think we are in a crisis or that we're going to be by reading the first opening paragraph.

I was wondering, since I don't think we are going to change that, in the second paragraph where it says, "While most Americans receive high-quality care, too many patients can receive sub-standard care," I was thinking you could at least delete the word "can," because I think many patients do receive sub-standard care and we prove that point throughout the entire report.

Secretary Shalala: Without objection. Anything on page two? You have a correction?

Executive Director Corrigan: Since the last meeting, we received correspondence from several groups that questioned the data that are extrapolated. If you look at that first bullet on page two, the avoidable errors, the study that was conducted by Lucien Leape and his colleagues was based on a sample of hospitals in a particular part of the U.S. In a subsequent publication, Doctor Leape made an extrapolation from the original data to get to this 180,000 figure for those who died, as well as to get to the estimate of this being equivalent to two major airline crashes.

Well, apparently, several groups, and there was sort of an ongoing debate as to whether that extrapolation was appropriate, and we think it's best that the Commission avoid getting into that debate, that's really not our issue, and there are many studies that support this issue of errors.

So, we are recommending that we replace those two sentences, so let me read you what this would be replaced with. We thought we would cite two different studies, the original Leape study and the actual findings, which were in a peer review journal, and then a second study by another author that support avoidable errors. So, what we would put into this is, many Americans are injured during the course of their treatment and some die prematurely as a result of avoidable errors. For example, a study of injuries to patients treated in hospitals in New York State found that 3.7 percent experienced adverse events of which 13.6 percent led to death and 2.6 percent permanent disability. That's the actual finding from the Leape study, no extrapolation, actual finding.

And then another study, this would say, a recent study found that from 1983 to 1993 deaths due to medication errors rose more than two-fold with 7,391 deaths attributable to medication errors in 1993 alone. That's a study by Phillips Nicholas & McGlenn.

Secretary Shalala: Now, that's a national study as opposed to a New York study?

Executive Director Corrigan: Yes.

Secretary Shalala: We may have to clarify that --

Executive Director Corrigan: It's out of Lancet.

Secretary Shalala: -- because you are following New York data with national data.

Don, how does that --

Commissioner Berwick: That's a Lancet study that just came out, and I have read the abstract but not the study.

Leape's figures are the lowest reported in recent literature, we should know, so we are still on safe ground.

Executive Director Corrigan: Better to have the two.

Secretary Shalala: But, this is a solid way to put it, in your judgment?

Commissioner Berwick: Yes.

Secretary Shalala: Okay.

Any other changes on page two of the Executive Summary?

Commissioner Reardon: May I ask a question?

Secretary Shalala: Yes, Doctor Reardon.

Commissioner Reardon: Thank you.

Don, on the next paragraph are under-utilization they say, "For example, 18,000 people die each year because they are not using beta blockers," is that an assumption that they all would have lived if they'd been on beta blockers? Do we know how many would or would not have died had they been on beta blockers? I mean, we are throwing a figure out there, can we not say that many patients die unnecessarily because of lack of use of beta blockers?

Commissioner Berwick: That figure comes -- it's actually not cited correctly here -- the figure comes from, the Sumerai study showed under use of beta blockers in people over 65 years of age, extreme under use, only 21 percent got the beta blockers. So, Sumerai was able to document under use.

Chassen extrapolated Simerai's figures, combined them with the randomized trials on beta blockers, and said that if the randomized trials could be applied then on a national level it would be 18,000 deaths.

Commissioner Reardon: Here again, we are talking about an extrapolation, which makes me nervous about using absolute figures.

Commissioner Berwick: Yes.

Commissioner Reardon: I agree that the beta blockers are grossly under utilized, and the figure for under use is 21 percent.

Executive Director Corrigan: There actually is a difference here. The groups that we heard from, the Physician Liability Association, have I got that right, at any rate, had tried to identify and figure out how Doctor Leape and his colleagues came to the 180,000 figure, and they were not able to identify how he reached 180,000 from the extrapolation.

So, it wasn't entirely an indictment of extrapolations, it was the particular one that was made and whether there was an error in making the extrapolation.

But, we certainly can, if you think it's better, we can go back and cite the actual beta blocker results, the actual study results, rather than the extrapolated data.

Commissioner Reardon: If I may, I think the point we're trying to make, that there is a problem of under utilization of beta blockers, which would be very beneficial, and I'm wondering about the absolute numbers that we are using as --

Secretary Shalala: Let's get as solid as we possibly can in terms of, so that there's no question about -- if we are making the general point then we don't have to use the exact numbers.

Any other, Don?

Commissioner Berwick: We can do that off line.

Secretary Shalala: Perhaps, you and Tom could just work and make sure we get that accurate, okay, in the most solid way we possibly can.

Anything else on page two of the Executive Summary?

If not, we'll move to page three.

Commissioner Malone: Madam Chair?

Secretary Shalala: Yes.

Commissioner Malone: I thought that last time someone had mentioned using the term "the National Advisory Council for Health Care Quality," and I didn't know whether that had been settled or whether we were -- so, was this an omission that it's not the National Advisory Council or is this something we just didn't really agree on?

Executive Director Corrigan: It was our sense that there wasn't agreement on that. We did, however, talk about it at the staff level, it came up, but it was our sense that there wasn't agreement. That's why we didn't incorporate it.

Secretary Shalala: Other comments on page three?

Page four. Alan?

Commissioner Weil: On page four, the paragraph that begins in bold, "Group purchasers," the very last sentence, I would just request that it say a small but growing group of private employers have been pushing for greater focus on quality, and then say, while public purchasers have also been emphasizing quality, so it's not just the federal, it's public purchasers at multiple levels.

Secretary Shalala: Right.

Anything else on page four?

If not, we'll move to page five. Yes, Mary.

Commissioner Wakefield: I just have an addition on behalf of Randy, who is away from the table for just a second, so I'm carrying his water, Madam Secretary, and it is on the fourth paragraph that begins with, "The Commission is pleased...," at the end of that sentence, after the word "Americans," he would like to see added, an estimated one third of Americans, and employers and health plans have also voluntarily committed to assure these protections to an additional 60 million Americans.

Secretary Shalala: That's fair.

Commissioner Wakefield: Okay.

Secretary Shalala: Absolutely.

Anything else on page five?

If not, we'll move to page six.

We're going to wrap up the Executive Summary. Okay, the Executive Summary is done.

Let me, as we're bringing in the copies to finish up Chapter 10, say a little about follow-up. There will be a number of things that will be available. I will write, Secretary Herman and I will get together and write to you about the follow-up on the Commission's report, including the availability of senior members of the staff to follow up with you and any organizations you may belong to.

I was suggesting to them that we do a video tape presentation, in part because I would like my department around the country to hear a presentation on the report. We will make those available too, there will be a number of different follow-ups.

The staff will disband as of the 1st of May, though I'm trying to encourage at least a couple of people to stay on for the follow-up, so we could make sure there is a follow-up, but we will detail this in a letter from the two of us as to how we will wrap this up, including how we are going to make copies available and other kinds of follow-up, as well as bringing you up to date on where we think the legislative process are, and we'll periodically update you through this congressional session, in particular, I think as to how things are moving along, as well as how some of these are being integrated as we get responses from the private sector in particular as they integrate parts of these recommendations.

And, about the follow-up, particularly on the consuls that we've recommended, both the outside one and the inside one, the inside one will certainly require congressional legislation and will have to be linked, but we will -- you'll get from us a follow-up document and an easy way to get answers to questions inside of our organizations as part of how we are organizing ourselves. I don't know whether you want to say anything more about that, Alexis.

Commissioner Thomas: Madam Secretary?

Secretary Shalala: Why don't we see whether anyone has any questions. We can also do the details of tonight tomorrow.

Commissioner Thomas: Is it confirmed that the Bill of Rights will be printed in the same final report?

Secretary Shalala: Yes.

Commissioner Thomas: Okay.

Secretary Shalala: I've asked that it be done, so I'm assuming that it will be done.

Commissioner Thomas: May I take the liberty of just saying that I'm afraid that I have to leave now for an out-of-town conflict, but I just wanted to say before I leave that this has been the most professionally satisfying experience of my life, and I really have enjoyed my time working with this Commission. Prior to the most contentious issue of the entire Commission's deliberations I plan to exit stage left.

But, please know that I've enjoyed working with each and every one of you and thank you very much, I appreciate it.

Secretary Shalala: Thank you, Peter, for your leadership.

(Applause.)

Commissioner Thomas: No applause line necessary.

Secretary Shalala: Okay, thank you, Peter.

Do you want to -- I've gone through and said we'll communicate with the members of the Commission two weeks from now as to what kinds of follow-up we're going to do and what kind of materials we'll make available, including we actually want to do a video so that we can send it in HHS around the country to inform our employees about what's in the Commission, and we'll pass it out to other people just as well.

But, would you take us through what we are doing tonight and tomorrow, and let's do the mechanics right now, since they are reproducing them. I take it we are few minutes away from actually getting -- I don't want to start the discussion without having the document in front of us, though I'm prepared to take any other comments on Chapter 10, other than the areas we've already discussed, but why don't you go ahead and tell us about the mechanics, where people should be tomorrow.

Executive Director Corrigan: Is this something burning, Herb?

Commissioner Pardes: If I could just make one comment. I would like to just suggest, and I wonder if other Commissioners feel the same, that having been a participant in creating this product, that there are a number of us that want to be helpful in seeing that it sees the light of day and has as much impact as possible.

So, I'll just say for myself, I suspect you'll get virtually similar feelings around the room, that any way we can help we are happy to serve.

Secretary Shalala: And, you'll be the key people on explaining what all of us did.

I just want to make sure we get materials to you in a variety of different ways so that they are useful.

Alexis?

Secretary Herman: But, I think taking what Herb has said a step further, I think it would probably be useful, though, if we could maintain, at least for the next couple of months, that we would have some staff presence of those of you who will be able to speak in public forums, or if you are able to use the materials in some way, that we can have more of a coordinated feedback opportunity through some kind of speaker's kit even, in terms of talking points, what we'd highlight, and maybe target audiences that we'd be talking to.

Commissioner Pardes: That would be very helpful, I suspect. I know I already have included this in some of my presentations, and I imagine other people have as well.

If you can give us whatever you think might be helpful that would be very good.

Secretary Herman: Right.

Executive Director Corrigan: A couple of things. We had hoped to -- we do plan to put together sort of a strategy for how to inform key groups and constituencies, both at the national level and the regional and local levels, of the work that the Commission has done on both consumer protection and quality of care. So, we will put together a speaker's kit for you. We have put together a set of slides, which one Commission member has seen and asked that he might have a copy, and I'll go ahead and send them out to everybody after they are updated after today's meeting to actually reflect all the final findings, as well as other information that I think would be particularly useful to you in hopefully going out and speaking about the Commission's work. And, we'd certainly encourage you to do as much of that as you can.

But, from the staff level, we will put together a list of key associations, as I said, both national and state and local, and then try to identify Commission members that would be able to go out and speak and hopefully spread the word.

Secretary Shalala asked me to go over what you can expect sort of tonight and tomorrow. We are going to be making the final changes to this document, in fact, that's why half of the staff isn't here because they are out making the final changes to various chapters of the document. That is then sent off to the group that's doing the final editing and typesetting, and they put it together overnight. They will be working a good deal of the night to be able to have this ready tomorrow.

This evening, we do have the event that the Secretaries are hosting for you, that is from 6:00 to 8:00, and it's at the Department of Health and Human Services on the sixth floor, and we'll have arrangements for you to get into that building and that will be set up. I have someone checking on transportation as well, so we can make that as easy as possible for you. It's in Secretary Shalala's office.

Tomorrow, the event at the White House is scheduled for 2:40. We don't know exactly where in the White House it's going to be, but you will want to arrive probably right around 2:00, would be most appropriate, and since they haven't notified us as of the exact location in the White House, the last we heard it might be in the Rose Garden, but I think that depends in part on weather.

As soon as they give us a confirmation on that we will tell you what gate to go to, so hopefully we will know that soon. We are trying to get them to nail that down, but one way or another we'll let you know about those arrangements as well.

It will probably be about a week before we actually get the bound copies of this document, maybe even as much as ten days. We are trying to get that done as quickly as possible. As soon as we do get the bound documents, in the meantime we will be able to provide you with a hard copy, it just won't be the pretty copy with the cover and the actual final, but we will be able to provide you with a final copy within the next couple of days. We'll have enough ready for press tomorrow and others that need to get their hands on it quickly, but as soon as we get the bound copies we'll be sending those out to you, and we'll also let you know if you want to order sizeable numbers of them to distribute to groups, we'll be glad to facilitate that process for you as well.

Secretary Shalala: Questions for Janet about the follow-up on the Commission or any ideas people may have?

If not -- yes, go ahead.

Commissioner Malone: Janet, how long do you expect the event with the President to last?

Executive Director Corrigan: About 20 minutes to a half hour. And, we did plan to -- we will have some cabs lined up for you, because I know many of you are going to be trying to get to National or Dulles for 4:00 flights. We don't anticipate you'd have any trouble with a 4:00 flight, it may be a little tight if it's something before that, but 4:00 and later should be okay, and we'll have the transportation ready.

And, I did, by way of update, just before I came back I went and checked with the small group that are working on the statement, and they all nodded affirmatively that things were going well and they thought they were almost there. They are putting the final touches on. We have had it typed up, and they are making their final changes and somebody will be off copying those, so we do expect that they are going to arrive in just a couple of minutes.

Secretary Shalala: Now, assuming that what we are going to see is a proposed recommendation three, and some other paragraphs related to the broader discussion that we had this morning, is there anything else in Chapter 10 that anyone else wants to raise so that we can get those recommendations and have them stand alone? Don?

Commissioner Berwick: Two on what I hope is the non-controversial part of the chapter.

Secretary Shalala: Okay.

Commissioner Berwick: I think the chapter should be titled differently, error free is not technically where we can head. I would suggest something like reducing errors and increasing safety in health care would be technically better.

Commissioner Malone: That's friendlier.

Commissioner Berwick: That's friendlier, too.

Secretary Shalala: Friendlier, yes, exactly.

Commissioner Berwick: Because technically you mitigate the effect of error, instead of going to zero.

Second, I've received a number of phone calls from the community that's expert in this, cautioning us to be careful not yet to recommend a national error reporting system. It's not a political issue, it's a technical one, which is what level of aggregation is really helpful or not.

So, I'd like to suggest we just take a look at the language. Error reporting systems are essential, but a comprehensive national one may not quite be where we'd turn out to need to go.

Secretary Shalala: Okay.

Paul?

Commissioner Montrone: On page seven there's a -- the last paragraph before "variation in current remedies," there's a statement, I'll read that, "Implementation in independent external review by public and private, et cetera, is an essential element in reducing the number of Americans injured by inappropriate coverage denials." It's the word "essential" that I'm focused on.

Secretary Shalala: What page, Paul?

Commissioner Montrone: Page seven. It seems to me, I interpret that as saying that without this we cannot reduce the number of these individuals, and I don't think it's essential in that sense. I'm just wondering if we could have a better word.

Executive Director Corrigan: I'm sorry, Paul, I got waylaid, can you try it one more time?

Secretary Herman: Say it again, Paul.

Commissioner Montrone: That's fine, page seven, the paragraph before the subcaption "variation in current remedies," the word "essential," I'm reading the word "essential" as meaning without it we are not going to be able to reduce the number of these Americans, and I don't that that's quite the case.

Executive Director Corrigan: An important element?

Commissioner Montrone: Yes, important element or something.

Secretary Herman: So, you want to drop that word, Paul?

Commissioner Weil: I knew we'd have a chance to disagree before the day was over.

This was in our Bill of Rights, as part of what we felt people should have access to, and I understand the sentiment, but I think important moves us further away from where we were when we said everyone should have it.

Commissioner Montrone: Well, what do we suggest?

Commissioner Weil: I was so happy with essential I didn't give it any thought until a moment ago, but I can react to important and say I don't think that's where I feel like we were when we put it in the Bill of Rights.

Commissioner Montrone: Well, you do agree that we could find other ways, additional ways, perhaps, of reducing the number of such injured Americans, right? So, if we didn't do this we could still reduce it, right? So, you are good at words, Alan.

Secretary Herman: So, Paul, is your objection to the word "essential"?

Commissioner Montrone: That's my objection, I'd like to see the word changed to something important but not essential.

Secretary Herman: Significant?

Secretary Shalala: Tom, let's see if Tom can give it.

Commissioner Reardon: Paul, I'm going to disagree also. I don't think essential means it's the only way, but that it's a very important way, and the way we've felt, I think, we should go.

I'm not taking essential as being the only way.

Commissioner Montrone: No, but essential means without it you are not going to get it, it's essential, you have to have it.

Commissioner Reardon: And, I think it's what we found was the best way, and the way we wanted to go, and having external review.

Secretary Shalala: Critical?

Commissioner Montrone: Critical? We could say critical, if you want to say that we recommend it as the best way, that's fine. Do you like that better?

Commissioner Reardon: This wordsmithing, I think we are getting -- I don't think it's the best way and essential are any different. Who has their Webster's?

Secretary Shalala: It doesn't sound to me like we have any agreement on changing what we've got. Good try.

Do you have another one you want to try?

We are -- let me tell you where our little group is. They are coming in to lay out some language for us. They had a problem in the software they are using, they are typing up now and they are going to reproduce it and bring it right in to us. So, it's not a debate that's going on in there, it's the mechanics of the production process. They had a compatibility problem with the software, apparently, held up by technology.

Kathleen?

Commissioner Sebelius: Madam Chair, again on page four, I continue to be a bit troubled by the fact, and this is not at all a criticism of the Department of Labor. In fact, I think the Secretary has agreed with us before that in order to expedite grievances you need a grievance mechanism in place that really isn't there now, and the Department of Labor has never been given the resources or the mandate to do that.

We've talked about that on several occasions, but it never has actually appeared in the text. We continue to focus on expediting the process as opposed to actually having a system that can be expedited.

And, I remember Secretary Herman at the last meeting also echoing the fact she thought I was actually making a budget endorsement, and I probably am, but I think when we discuss internal appeals, and the Department of Labor looking at expediting, we also need to recognize that they may need resources to put in place a mechanism throughout the country to respond to complaints, whether it's 180 days, or 20 days, or two days, it doesn't exist now. So, expediting is a piece of the puzzle, but having the resources to do that is the other piece.

Secretary Shalala: Do you have a sentence suggestion, Kathleen?

Executive Director Corrigan: We are at the bottom of the page, the paragraph that begins, "On February 20..." --

Commissioner Sebelius: Right, yes, something that just talks about, yes, the resources needed to respond to consumer complaints.

I'm sorry, we are talking about the internal appeals system and the Department of --

Secretary Shalala: Page six, paragraph --

Commissioner Sebelius: -- two paragraphs.

Secretary Shalala: Two paragraphs. It starts, the paragraph starts -- read the beginning of the paragraph.

Commissioner Sebelius: Well, paragraphs four and five on page six talk about the Department of Labor looking at revising regulations and expediting appeals. I think we need a sentence to recognize that they may need additional resources to respond to the complaints as they come in. That's my concern, not that anything that's here be changed, but in addition to expediting we need the mechanism to respond, and the resources to respond, because they are not there.

Secretary Shalala: So, you just want to add a resource sentence. We can do that in the editing of it.

Mary and Steve.

Kathleen, did you have something else?

Commissioner Sebelius: No, I'm just wondering, I don't think it changes the substance.

Secretary Shalala: No, it doesn't.

Commissioner Sebelius: And, in fact, I think it's been agreed to several times, we just need to capture it.

Secretary Shalala: Mary?

Commissioner Wakefield: Again, I'm asking this question on behalf of Randy. I think I'm being asked to ask these questions by virtue of where I'm seated. But, this is a question, since he's not here, that he'd like to have raised, and that is on that very same paragraph beginning, "On February 20th...," his question is, is the 15 days on the third line, is that correct or should it read 15 -- or, is 15 days a typographical error? So, is it 15 days, or is that a typographical error?

And, related to that, he's also saying, can it be done in 15 days, is it necessary for it to be done in 15 days? And then, his last question is, should it be the same as Medicare, i.e., 60 days?

So, those are the questions he wanted to have raised.

Secretary Herman: It is 15 days, Mary, and there is a provision that provides for longer time for claims that are not complete.

Commissioner Wakefield: And then, is there any view on whether or not there should be some consistency between that number and Medicare's? The question was fully explored?

Shock to you, but I'm carrying your water for you.

Secretary Shalala: The idea that Medicare could make a decision in 15 days is overwhelming to me.

Commissioner Weil: Isn't the right answer that if he'll agree to consistent remedies we'll agree to consistent time lines?

Commissioner Wakefield: I'm sure --

Secretary Shalala: We'll leave that one out.

No, no, we are talking about non-urgent care decisions. What's the answer to this question for the staff?

Executive Director Corrigan: It stands as is, that's what the Department of Labor's position is.

Secretary Shalala: Yes, that's our position, based on the public comment period.

Executive Director Corrigan: We are just reiterating what their position is.

Secretary Shalala: Okay. So, we are just repeating what that position -- that it is really 15 days. Okay?

Any other questions about Chapter 10? We are going to get into the changes.

Yes, Beverly?

Commissioner Malone: I just want to mention, on page four, the first paragraph that begins under, "Identifying and reporting errors, Efforts by the medical profession...," and I'd like that changed to efforts by the health professions.

Secretary Shalala: Okay, but, well, we might say medical and other health professionals. Did someone get that change. Okay.

Go ahead.

Secretary Herman: Are we ready?

Secretary Shalala: Yes, Val?

Commissioner Halamandaris: Madam Secretary, it's a small point in the context of Chapter 10, and I'm making reference to the chart on page eight, which refers to the fact that there are 124 million people in ERISA covered points. Nothing is more maddening than inconsistent data in statistics.

In Chapter two, we use a different number, we use 122 or 123 million. May I make a plea to have a final read and make sure that we are consistent --

Secretary Shalala: Yes.

Commissioner Halamandaris: -- with the use of numbers?

Secretary Shalala: Yes, did someone get that?

All right, let's go.

Yes, we'll make it consistent.

Any other changes to Chapter 10?

I'm going to move to Sandra for presentation. We have the pieces, have we got it?

Sandra, why don't you talk.

Commissioner Hernandez: Yes, what is coming around to the Commissioners will be two documents. One of them is the proposed recommendation number three, which I'd like to go through first. This really picks up on the point, Betty, I think you made earlier this morning, and is one that I think, I hope, we can agree to.

On the one that's being handed out, if you would make -- I want to read it as it would be amended, there's two words that have been added to the copy going around now. Does everybody have one? Copies? Would you raise your hand if you don't have a copy? It's a very short one. That's it. "Proposed Recommendation Number Three," is what it says at the top of the page. "Policymakers should engage in a national dialogue regarding the current state of existing remedies for individuals in public or private plans who are injured as a result of inappropriate health care decisions. They should carefully consider the cost, intended and unintended consequences of both the status quo, as well as any revisions to existing policy."

Secretary Shalala: Read it again.

Commissioner Hernandez: "Policymakers should engage in a national dialogue regarding the current state of existing remedies for individuals in public or private plans who are injured as a result of inappropriate health care decisions. They should carefully consider the cost, intended and unintended consequences of both the status quo, as well as any revisions to existing policy."

There's two words that --

Secretary Shalala: She's adding two words, that's why I had Sandra read it twice to you.

Commissioner Hernandez: For grammar, it was important that we were looking at consequences intended and unintended of both the status quo as well as to revisions. That's the emphasis added in both.

The intent here really was in trying to reflect this morning's discussion and previous discussions, and the reality is that there is ongoing national dialogue about this. We think that this recommendation, we hope this recommendation serves to clarify what the later document, as we're going to propose to be amended, would reflect in terms of, in essence, a do nothing status quo scenario and what the consequences are or not of that, as well as consequences intended and otherwise, as we've heard articulated I think fairly clearly from Randy and others on the conference call about consequences potentially of revising existing policy.

So, I think that says, let's keep talking and keep trying to move this ball a little further down the court, and does add a recommendation to that.

Secretary Shalala: So, this recommendation also refers to the text change that you are recommending.

Commissioner Hernandez: That's correct.

Secretary Shalala: Would you please go to the text change, and we are going to take it all up at once.

And, would someone retype the proposed recommendation and bring it back in, so we have it in final.

Commissioner Hernandez: The proposed additional page that was handed out would, in effect, if you'd turn to page nine of the chapter as it was introduced today --

Secretary Shalala: We're talking about Chapter 10, the red line version.

Commissioner Hernandez: Chapter 10, page nine, where it says, "Issues for Consideration." What we would propose is starting that section with the recommendation I just read, and then following with the handout.

Secretary Shalala: Let me clarify that. The recommendation is going under the recommendation section --

Commissioner Hernandez: It's going on page one.

Secretary Shalala: -- on page one.

Commissioner Hernandez: And, it is also going --

Secretary Shalala: And, it would go here under "Issues for Consideration."

Commissioner Hernandez: -- as the beginning of that section.

Secretary Shalala: Okay.

Commissioner Hernandez: It would then follow, Secretary Herman and Commissioners, with the following three paragraphs, and let me just give some context to the paragraphs.

What we were trying to do here is summarize the varied expert testimony heard by this Commission on the issue of remedies, but does not draw a conclusion, it simply is meant to try to define, as we heard varied expert testimony on this issue. It does not attempt to say which is the right or wrong read on the situation, or to draw any significant conclusions, but we think it better articulates the positions that expert testimony gave to this Commission over the course of five or so panels that we heard from.

So, it does not lead us to any change in the conclusion whatsoever, it's added text that we think better captures the positions that we heard from expert testimony.

Secretary Shalala: Let me remind everybody where it goes. We are talking about page nine, the bold head is, "Issues for Consideration," the recommendation goes first and then the three paragraphs that describe, essentially, the testimony that the Commission has heard and does not come to any conclusions, but describes that testimony as a way of describing the issues in this debate.

Go ahead.

Commissioner Hernandez: Many Commissioners asked us to recognize in the text that there are multiple options, and the first paragraph, basically, sets forward that notion, that we've heard a lot of testimony, that there are different ramifications to individuals in public and private plans, and that multiple options should be carefully considered. It then lays out, fairly cleaning, I hope, the two relative positions about how aggressive to be in pursuing reform, or what the potential position would be on a status quo situation.

Secretary Shalala: Let me remind you again that the entire section, "Issues for Consideration," that you now see would go out, and what would be substituted is the recommendation and these three paragraphs. And, I want to give everybody an opportunity to read through this before I take comments on it.

Commissioner Sebelius: Madam Chair, I have just one question.

Secretary Shalala: Yes.

Commissioner Sebelius: In addition to the recommendation appearing as cited on page nine, would it also --

Secretary Shalala: Yes.

Commissioner Sebelius: -- appear on page one?

Secretary Shalala: It would appear on page one, too. So, the recommendation number three appears on page one, it appears again after "Issues for Consideration," we would strike what currently is in the section on "Issues and Consideration," and substitute the recommendation plus these three paragraphs.

I will now take comments on the proposal.

Tom?

Commissioner Reardon: I, Madam Secretary, would just like to compliment the group that worked on this. This is a contentious issue, it's had a lot of debate. It's very difficult for certain people at the table, I know, including Randy and others, and I want to compliment them. I think this is a good addition.

Secretary Shalala: Additional comments?

Alan?

Commissioner Weil: I just have a question. I completely agree with Tom, this is very nicely done.

On the recommendation language, it says, in the third line, it says, "inappropriate health care decisions," that could mean both plan denials and medical decision and, therefore, would get into the whole malpractice issue, and I just want to be clear that the intention is to raise this issue with respect to both of those subjects. Otherwise, I think we should be more precise.

Secretary Shalala: Sandra?

Commissioner Hernandez: I think we've heard from this Commission a sense that we need, in fact, to look at both. This is worded such that you can, in fact, do that, and it was quite intended.

It also reflects language in the text where we specifically talk about what we mean by inappropriate.

Secretary Shalala: Beverly?

Commissioner Malone: I think that the subgroup did an outstanding job. My question has to do with how many times "heard testimony from witnesses" is used throughout the statement. For example, in the third paragraph, in the first sentence, "The Commission also heard testimony," in the second sentence, and it's sort of very thoroughly repeated, repeated again and again. It would seem that if at the start you could say you heard testimony, that then you could say and the summary of that is as follows. It's as if we want to put it at such a great distance from ourselves that we don't want to be associated with it.

And, I understand that a little bit, but I would think that --

Secretary Shalala: Why don't we let Sandra respond to that. It's an editing point, I think, and a substantive point.

Commissioner Hernandez: It is both. I think the editing point is extremely well taken. What we were trying to exercise extreme caution about was not to be divisive by representing positions of specific Commissioners, although clearly some Commissioners would choose one set of expert opinions versus another.

Secretary Shalala: Yes.

Randy?

Commissioner MacDonald: Because I have been self-nominated on the grammar of this, I understand really very clearly the repetitious, but it is, in my mind, clearly by intention.

Secretary Shalala: Fine.

Marta?

Commissioner Prado: I was just going to ask Sandra, on the fact that we're going to put the third recommendation under that heading, none of the other recommendations are repeated as a recommendation throughout the document. And, I just think for uniformity, if we are going to put just that one recommendation, either we put all the other ones, or we don't put just one by itself.

Secretary Shalala: I think I -- Sandra, I think that's an editing point, but not necessarily a substantive point that Marta is making.

Commissioner Hernandez: It isn't, and if we are going to be consistent then what I'd ask is, is that we repeat the recommendations of the other two in the document, because it is a good preamble for this section.

Secretary Shalala: We'll figure out how to do that.

Other comments? I want to go around the room on other comments, specifically, on this recommendation from the group.

Gail?

Commissioner Warden: I'm fine with that.

Secretary Shalala: Okay.

Bob?

Steve?

Marta, you are fine?

Sandra? Okay.

Val, Don, Sheldon, Gerry, Governor Ray?

Commissioner Ray: Well, just not a very substantive matter, but the sixth line down in the second paragraph, "... to the extent necessary to allow damages," it seems to me like it ought to be for recovery of damages or restitution, or something.

Secretary Shalala: We'll figure that out.

Chris?

Sylvia?

Commissioner Ivie: Does the -- in proposed recommendation three, do we have to limit it just to policymakers? Is there any broader category of people that we might mention?

One of the great strengths of our debate has been that the public has had an opportunity, through our conversations and the various testimonies, to learn about this topic, and I would like them to continue to learn about it.

Commissioner Hernandez: I think that's a valid point. We could certainly say policymakers and other stakeholders.

Secretary Shalala: Okay.

Alan?

Commissioner Weil: How about, policymakers should lead a national dialogue, because we do need them in it, but then, they are bringing others in.

Secretary Shalala: But, the problem with the word "policymakers," it suggests that it's politicians as opposed to the private sector, too, and I think that we want to be careful about that.

But, Sylvia, I think your point is well taken and we'll figure out a way to broaden it. I think other stakeholders may do it.

Commissioner Montrone: I'll comment here. In the last paragraph, it seems to me that the thrust of paragraph two is we need better remedies. Then we go next into watch out for these remedies, and buried down there near the end, where we say "finally," that sentence there, "The Commission heard testimony that the current system has provided a framework...," et cetera, it seems to me that that should be the lead in to that last paragraph.

Secretary Shalala: Randy?

Commissioner MacDonald: Just move it up, reorganization.

Secretary Shalala: Just move it up, okay.

Randy, any additional comments?

Commissioner MacDonald: None.

Secretary Shalala: Mary?

Kathleen?

Commissioner Sebelius: Good job.

Secretary Shalala: Alan?

Richard, you are out of it.

All right. Done.

(Applause.)

Secretary Shalala: Let me congratulate Sandra for a masterful job, and thank Randy for his leadership.

(Applause.)

Secretary Shalala: And, everybody else.

And, let me turn over the Chair to -- Nan, you were great, and Ron and Alan, whoever, everybody that was in the pot, everybody who was in the pot -- let me turn the Chair over to Secretary Herman.

Secretary Herman: Thank you very much, Secretary Shalala, and let me again thank the leadership of Chapter 10 for getting us to this point.

And, what I'd like to do now in bringing the meeting to a close, is to take a few moments to go around the room and to literally give each of you the opportunity, or to go on the record with your fellow Commissioners, in terms of any final comments that you would like to make regarding the work, the report.

Obviously, we are not back to any substantive issues on the report, particularly, having just concluded the infamous Chapter 10, but certainly, I think it is an appropriate time for each of us to add our own expressions of commendation or any comments that you would feel appropriate at this time.

And so, I'm going to begin to my left, and to ask Alan if you would like to make any concluding comments for the record, Alan?

Commissioner Weil: Well, I have found this a very rewarding experience as well, without belaboring the points. I particularly want to thank the Co-Chairs for the incredible investment of time and leadership on this issue. I think this would not have happened without the personal involvement of the two of you, and I have enjoyed working with all of you.

I have in my back pocket a resolution to extend the life of this Commission for an additional year, and I would like to put that on the tape.

Secretary Herman: We'll rule you out of order on that last comment, Alan. Thank you for the other comments.

Kathleen?

Commissioner Sebelius: Well, I, too, have found this kind of a remarkable process. I must confess to being frustrated at times, but I think because of the importance of the work that we attempted to tackle here, the frustration is a natural outcome of arriving at some consensus.

I continue to be amazed that two Cabinet Secretaries have been with us on the kind of constant basis that both of you have. I expected, when I saw the names listed as Chairs, that there would be a brief cameo maybe at the front end, a couple photo ups, and, you know, some kind of signed picture, and I have been extraordinarily impressed with, not only the time and dedication given your schedules, but awed by the expertise that both of you brought to the table in the discussion. I don't have any doubt that the dialogue would have been far poorer had you not been here.

I know that I've learned far more than I have contributed to this process, and whatever happens with this on a national, local level, I certainly have picked up lots of resources to use in my job on an ongoing basis. So, it has been extraordinarily rewarding.

I'm sorry I cannot join you tonight or tomorrow. I regret that, because it would be nice to be there for the finale, but it's been a wonderful opportunity.

Secretary Herman: Thank you, Kathleen.

Ron?

Commissioner Pollack: I feel like I'm going to be an echo. I very much appreciate the work of so many people seated around this table, and I, too, would want to start with the two Secretaries.

As I said to Secretary Shalala, for the brief moment I was in the lunchroom, that I thought she, and I say now to you, Secretary Herman, the two of you are extraordinary leaders, you are extraordinary in handling a group dynamic that is very difficult. I think I learned a great deal watching the two of you. The two of you have very complimentary skills and served us very well.

I also want to say it was a good experience to work with various colleagues seated around the table, those who I agreed with, and those who I occasionally disagreed with. I found that the spirit of those discussions I thought was positive, and I hope that a lot of other difficult decision-making can be done with the same spirit that each of you brought to this table.

Lastly, I want to say, once again, this staff is extraordinary. This staff has performed so incredibly admirably. When I looked at other commissions that I've been interested in, though, not been a party to, I think one of the real differences is the quality of the staff work that has been consistent throughout this process. It's been done with cheer, under the most difficult circumstances, and when arms had to be twisted they were twisted with dignity, and I very much treasured having that opportunity to work with the staff.

Lastly, I want to say, as much as I felt I learned from the process, I hope all of us feel good that we've made a contribution to the American public. And, I think we have, and I hope that we see our words put into action.

Thank you.

Commissioner Wakefield: Well, I guess I'll just echo the echo.

I, too, want to say that it's been a real privilege to serve under the leadership of both Secretaries and the tremendous job that they have done. It's also been a privilege to serve as a subcommittee chair.

I would like to commend both of the Chairs and the staff as well, and to say that I found what I think were one of the strengths of this Commission to be its incredible openness to opinion, views that were expressed by people who were not Commissioners. So, for example, the fact that a web site was set up in order to better disseminate information, the fact that every time someone picked up the phone to call me and express a concern about some focus of our work, that when I referred them to the Commission staff, any one individual staffer, there wasn't one of those individuals from outside of this Commission who came back to me and said, my views weren't adequately addressed. So, the openness on the part of the staff I think was just commendable.

And also, the willingness to entertain and the encouragement to entertain views from members who testified before this Commission, so that there was always an opportunity for individuals to come before the Commission and have their views heard. I just really want to say that I think the openness with which this Commission was run is absolutely commendable, and it should serve as a role model.

The last thing that I guess I would say is that, well, two last points, one, I frequently thought about, in the course of our dialogue, about a quote that kept coming back to me, that was attributed to a journalist who was from Europe, and this was many years ago, he was commenting on the formation of the European Union, and this is what he said about the different countries as they struggled with that formation, he said: "We all share the same sky, we just have different horizons." And, I think all of us brought very different horizons to this discussion, but without a doubt in my mind every single person here at this table was concerned first and foremost, I think, about consumers. So, we all shared a same concern, we just brought different horizons. I think it was very applicable to the work of the Commission.

And finally, I guess my final point is just this, thank you to the staffperson who sat me between these two wonderful, bright, articulate individuals on this closing Commission meeting. I can't think of two individuals for whom I'd have greater respect about how well they articulate their views, even though I might not have always agreed with them, it has truly been a delight to work with both of them and the rest of the Commission.

Thank you.

Secretary Herman: Thank you.

Randy?

Commissioner MacDonald: Well, it's somewhat scary, Mary, because as Ron spoke I looked down at the notes that I had written, and what's scary, Ron, is that I was going to say the exact same thing. We have finally found common ground.

I actually think that we have found common ground many times. There's three components here, when you think about it. It's the staff, it's your leadership, the Secretaries, and it's us, the Commissioners. And, if you looked at what made this work in my mind was that there were four attributes. We had the chemistry, we had the candor, we had the maturity and we had the professionalism. And, I think when all is said and done, I'm not sure exactly what history will say, I was always fascinated by people talking about historians, but if there's one thing I would hope for it is that the historians would recognize those attributes as qualities that we should find in all of our government.

In addition to that, I would suggest that I hope that our efforts ultimately end up as the benefit for all of our fellow citizens.

Thank you.

Commissioner Montrone: Well, a lot of this is echoes. I can't help but agree with my colleagues.

I would just frame it like, what is the most impressive, what was I most impressed with, and I guess, number one, in addition to the leadership, especially the element of the leadership that decided this should be a consensus group, I think that was a brilliant, brilliant move, and I think that that set an atmosphere for a high level of civilized debate and respect for the views of others.

And, I think what Mary said about us coming from our different vantage points, I think the learning process that we all went through, having come from one specific aspect as a health care industry, and the respect that we gave each and every one of our other Commissioners, I think was a very impressive point to make.

The second one, again Mary brought up, which I think this looks like a Commission of 34 members, but really incorporated the thoughts and ideas of a much broader, broader region to the industry, and I think that our work will go on a lot stronger because of that.

I think that we -- I didn't expect this, but I think we are producing a report, but I think it's really we became a focal point for the debate, and I'm impressed by the fact that the debate that we've encompassed in this report is something that people can start with. We've martialed the debate, we've martialed the evidence, and people can begin, once again, to go from there.

I think, as I go back and look at high points, I certainly think that the high point, I tend to look at the entertaining side of things, will certainly remain Sheldon's retrying of that case against AT&T that he won five or ten years ago, right here in front of the Commission. All you members weren't present for that. And, there are other great high points, but that was the one, Sheldon.

So, I'm honored and very grateful for having the opportunity to participate with all of you on this project.

Commissioner Pardes: Well, I feel I'm speaking as a representative of the city, which is the national capital of civility, and I first want to indicate to Randy that I'm going to, as an ambassador from Ed Giuliani, I'm going to bring back that term of dignified arm twisting, because I think it can facilitate our campaign dramatically in New York.

Second, I think everybody in the room, I resonate to the comments regarding the extraordinary talent in the staff, the wonderful Commissioners that were put together, and the phenomenal leadership of Secretary Shalala and Secretary Herman, who, not only put an enormous amount of time and led the way, but also conducted this, I must say, in an atmosphere which made us feel as friends and really people trying to work out something together.

I think that for me we've accomplished a lot. However, I wouldn't be fully expressing my opinion if I didn't say that I think we are a work in progress, and that, perhaps, many of us in different ways have goals that we'd like to see for the ideal health system you never quite reach, and I think we made a number of steps in that direction, but I think there are going to have to be a number of subsequent efforts.

For me, it's intolerable that a number of people in this country don't have health insurance and that it's not for everybody, and I suspect there are others who feel that way around the room. And, on the other hand, we respect the many colleagues who also tell us about that very other critical side, which is the financial.

So, I'm delighted and will be a proud booster and advocate in our alumni association, which we are forming right as this closes, because we will probably meet on regular events, and do fundraising, and banner wagging, and I just want to thank you all for the experience, my experience, of being able to work with and learn from so many good new friends.

Secretary Herman: Betty?

Commissioner Bednarczyk: Well, so much has been said already, but I do want to add my thanks to the Co-Chairs who have shown such wonderful leadership, and to a fabulous staff who has worked with us all this time, and I can truly say they have worked.

But, I do want to say how impressed I have truly been with this whole Commission, with the openness, the honesty and the respect that has been shown for other people's views. It has truly been a privilege for me to have worked with all of -- everyone on this Commission and to have gotten to know them, and it has truly been a wonderful experience.

Commissioner Nudelman: I, too, want to echo all the kudos to the staff, which was truly outstanding, and to Co-Chairs.

The mutual respect that developed with the Commissioners I think is outstanding. I think those who have observed the openness of the meeting are not aware of the amount of tremendous contact that went on between individuals outside of the meetings, just one on one to share opinions and views.

My only regret in the whole thing is that we spent a lot of time and effort up in the northwest keeping the rain in California so you could come to Seattle, but you never really made it and we'd like to invite you all to come at any time.

Commissioner Ivie: My concern with the Commission, which I have greatly enjoyed and learned from, has been involved principally with the status of poor people, women and minorities in this country, and how they are faring in all of the changes that are going on in this country.

I was very gratified at the meeting at the White House yesterday to hear from a variety of women's leaders about how extremely impressed they are with what we have been able to accomplish for women in this country, who are facing all these changes. I think we need to take this as a first very important step in terms of amassing just a great deal of current important information to get it to poor people, poor people's representatives, minorities, minority representatives, so that the learning that has gone on at this table can also reach those constituencies.

And, I'm hopeful that the video that's being developed, and that talking points, and that the work of each Commissioner will bear the need of those constituencies to participate in what we've been doing here, because this is information that those constituencies desperately need, and we've put together something that I think, even now with our Chapter 10, those constituencies can understand and can move on in their own interests to get reform that is needed in all these different areas.

So, I'm very grateful for the opportunity to have learned and to bring this information back to those communities, and I share everyone's statements, it's been extraordinary.

Commissioner Queram: This has been a richly rewarding experience for me, and it has, indeed, been a privilege to serve on the Commission, and I agree with everything that's been said about the caliber of the staff, and the leadership from the Co-Chairs, and the participation of all of the Commissioners.

One of the observations that I'd make is, being involved in something like this provides you with an unexpected but very real bully pulpit to take the work of the Commission back into the communities or the organizations in which we serve or reside. And, I've been, at times, a bit dismayed, frankly, at the tendency of people who are considerably far removed from the work of a group like this, to dismiss it as somewhat immaterial, or insignificant, or in some cases to perceive it as a stalking horse for something that might be more insidious or harmful to a particular organization's interests.

And, I think one of those strengths of consensus process, and I choose to view it as that, as a consensus process, is it provides all of us, I think, with the ability to leverage our agreement on difficult issues to stand up for what we believe in as opposed to what we oppose.

And, I would just echo, I think, a comment made from both of the Co-Chairs to exhort all of us to provide leadership within our organizations and within our communities to ensure that all of the time, and the energy, and the effort that we've put into our recommendations on both consumer protections and quality does not end up simply on a bookshelf in various offices.

So, through all available means I think we have the ability intellectually and emotionally around the table to see that our work leads to significant improvements for all.

So, it's been a privilege and I appreciate it very much.

Secretary Herman: Thank you.

Commissioner Ray: First, I want to ask some forgiveness of Sheldon, because what I want to say is that I've listened to all of my fellow colleagues here speak so eloquently, and they had something to say, and they said it in brief, which means they are not lawyers.

I want to add my sincere thanks to you who are the leaders of this Commission. Janet, you've done an outstanding job, and when it comes to the staff I think the applause that you heard this morning speaks a lot louder than words for the significant contribution that you all made and the appreciation of this Commission. And, the two Secretaries, I don't know where there could be better leadership than what you have given this Commission. And, you know, what's interesting about it is, I'm a devout Republican, and it makes me feel kind of good to say that about Democrats.

This report is the result of a lot of good effort from a lot of people who are very intelligent, very knowledgeable, and brought a lot to the table. I think it's amazing the debate that was so civil, and yet, accomplished so much, the Bill of Rights being a beautiful example of how something was forged by a number of people with varying opinions, and yet, it is significant. And so, I would hope that all of us will not only speak favorably about that Bill of Rights, but will promote it, because it will help health care, and the delivery of health care, and the health of the people of this country.

I just would say thank you for giving me the opportunity to serve with this group of people and to observe the leadership of you people.

Secretary Herman: Thank you very much, Governor.

Gerry, I'm going to ask if we could take a break and go to Gail --

Commissioner McEntee: Sure.

Secretary Herman: -- who I've just been informed has a plane to catch. So, we are going to go out of order to you, Gail, so that you can catch your plane.

Commissioner Warden: I apologize for going out of order, but Kathleen and I are on kind of a tight time frame.

As a Commissioner, I would echo what's been said about the quality of the staff, and the collegiality of this Commission.

I guess my comments would be very brief about a couple things. Number one, I am very pleased with the products that have come out of this Commission, the Bill of Rights, the fact that we finally are putting on the table some national aims for the health system, and the fact that we, on the one hand, are admitting that there is room for improvement, but we also are proposing a way that this Commission can be followed through on through the public/private partnership.

One of the great concerns of our subcommittee was that the report would end up on someone's shelf and that there wouldn't be a way to implement it. And, I think the public/private partnership should allow us to do that.

And, the final thing I would say is that, when I was asked to co-chair the fourth subcommittee with Sandra, who I did not know before, I was willing to do it but I didn't realize what an opportunity it was to get to know her and what a great person she was going to be to work with. And, Sandra, I want to thank you for all you've done, too.

Thank you.

Secretary Herman: Thank you, Gail.

Gerald?

Commissioner McEntee: Sitting next to the Governor, and he said he's a devout Republican, I must preface my remarks that I'm a devout Democrat.

I would have to say that I think it's a remarkable document that has been produced on an extremely difficult subject.

When the Commission began, really with this kind of Commission that represented such diverging points of view on this subject, and probably on a lot of other subjects, to bring it all together in a document that has been accepted by all, and through a process that we don't, in the labor movement, use very often, I mean, you refer to it as consensus, but to a large degree it was unanimity. And, that's truly, I guess, one of the secrets of this Commission and the document that it produced.

I remember the first time I talked to Janet, and we had an argument about the formulation of the subcommittees, but I mean that the staff, and the leadership, and the Commission members that have all worked extremely hard to put it together, I think have done an absolutely remarkable job.

And, I think that it's a Commission and its work, somebody said earlier work in progress, and I think it will be a work in progress. It's important to note that it's already generated discussions in a lot of other places on the subject of health care consumers and on the basic subject of health care. I said earlier this morning that we've been talking in the AFL-CIO about diverging points of view, in terms of ERISA and coming together on an important issue, and I think that this Commission generated that kind of discussion, that kind of hallmark.

And, I think that the document will produce a lot of things in this country and across the country, and I would just applaud, as I said, the staff and the leadership, both Secretaries, and I guess I would ask Secretary Shalala, as I watched how she runs these meetings, and we in the labor movement have an awful lot of meetings, that besides receiving a document I'd like to take your gavel with me when I leave, Secretary Shalala, but it's been a pleasure and a remarkable experience, and I thank everybody that participated.

Secretary Herman: Thank you, Gerry.

Sheldon?

Commissioner Weinhaus: Yes. I'd like to say I am truly highly privileged, and have always felt that way, to be named to this Commission, having no constituency and simply working in the hustings.

And, I appreciate the work of the Chairpersons, and from my viewpoint of operating in a very contentious atmosphere most of my life, to really meet people who all were of good will and tried to reach agreement. It's refreshing for me.

From my own point of view, it was always a difficult problem because so many people, or so few people can really afford attorneys, or find attorneys in this case, and the fact that we might win some cases and alleviate these problems does not really address the question of what do we do for people. There is more people out there than attorneys can really afford to help or have the time to help, even if they wanted to.

And, we feel that while we are attempting to make law, unless we get a case in the Supreme Court where we do help to establish law, we do nothing. So, I feel particularly honorable to know that we have set a course here that, while we talk about sometimes litigation and other things, in fact, in my view, it will reduce litigation because it will help people to be able to speak for themselves and to take care of their own problems on their own basis.

Thank you.

Commissioner Berwick: I also feel privileged having been part of this really honored -- and I've never seen better Chairs, and I've never seen better staff, and I don't think I ever will. I'm very grateful to you all, and to my fellow Commissioners.

I want to say a word on the document. I think it's superb, the focus on improvement, the focus on the real issues we were asked to deal with, the level of documentation, the detail, this is an archival piece of work that will stand the industry in good stead for quite a while.

It doesn't say everything I wish it did, and I think everybody in the group feels that, but every time I felt that I took a step back and reminded myself, this is a trillion dollar industry in a 20-year transition, really. For the first time that I know there exists a document now to guide further direction and work toward real improvement and real change in the industry. That's a landmark, it's a threshold piece of work, and I expect it is important.

It will be important only to the extent, though, that people take action on it, and I do hope we all find ways to move this on to the next step, and speaking as Herb Pardes did earlier, as a Commissioner I look forward to any way I can help to move this into action. It ought to be a call to arms.

But, I thank everybody that's contributed to it, and I'll miss you all, although I won't miss Flight 1603 at 6:00 in the morning from Boston.

Commissioner Halamandaris: Madam Secretary, I, too, want to add my thanks to my fellow Commission members for allowing us to be together to discuss these issues.

I'd particularly like to thank the President of the United States. I don't believe anybody has mentioned him to this point, but last I heard there were about a 1/4 million people who put their names in who wanted to be on this Commission, and he selected the 34 of us, and I think that's damn good work on his part. So, we certainly want to give him credit, and, hopefully, we've vindicated the wisdom of his selection. I think that's to be proven yet, but for the most part we can say, each and every one of us, that we did our best.

I would like to echo the comments about the leadership provided by the two Secretaries, Secretary Shalala, Secretary Herman. I thought it was extraordinary. I think all of us learned a great deal from watching you, having the privilege of being in the same room with you for this period of time, it was a high privilege for us. I want to say that and put it on the record.

I want to thank the individuals who sacrificed most, and that is Janet's children, but for their forbearance and allowing us to share, share you with us, we could not have achieved everything we've achieved. And, I've said it before, I've seen a lot of Commissions, but I've never seen such an extraordinary staff. So, I commend you, too.

I think on the part of my Commissioners, we did something I hope we would do, which was people were able to take off their hats, whatever was the self-interest, I did not hear one person stand up here and say, in my industry, or this or that, I think everybody took off their self-interest and was considering the broader view of what is good for the American public, and I do think that is an extraordinary achievement.

So, I want to thank everybody. It's been a pleasure and a privilege to be here.

Secretary Herman: Thank you, Val.

Sandra?

Commissioner Hernandez: Thank you, Madam Secretary.

I, too, want to just express the privilege that I felt to be able to work with both of the Secretaries. It's always wonderful to watch other people try to chair consensus and diverging opinions, and it has been a very educational process for me. And, as Kathleen said, I think when you think about trying to come to a table and make a difference, you hope that you give at least as much as you are able to take away, and I took away a tremendous amount. I learned a lot from fellow Commissioners.

I want to give a very personal thank you to Ann Page, who I don't think as a subcommittee we've had the opportunity to do, but she really represents the entire caliber of your staff, Janet, but was really exceptional, not just in professionalism as has been expressed, but also in patience, tolerance and wisdom, which is a conglomeration of attributes for staff that I think is really quite accurate.

And lastly, let me just say that I hope we've changed the leftist image of San Francisco, so that we can sort of think of the bridge role of San Francisco, and now, Phil, I know who to blame for all the rain that we've had there.

It's been a real pleasure to serve. I am very proud of the document that we put together as a group and with staff. I do think that in two years, and in four years, we need to pick it up and sort of say, did we move it? And, if we have at all we've made a significant improvement towards quality in the industry, and that's something that I think we can all be proud of.

Commissioner Prado: It's so hard to find some words that sound a little bit more unique than have been said before, but I also wanted to thank the President, who appointed two great Co-Chairs, who hired wonderful staff, who led us in an incredible lesson in government into sunshine, as it should be, because I don't think that there was any issues that were not able to be discussed.

I want to thank Ms. Coochak for having kept us on our toes, and I want to thank the Commissioners, for me it has also been an honor and a privilege, and I'm very proud of the document, but I think that we would be remiss as a Commission if we did not take the step further about an issue that we have discussed, and while it was not the privy of the Commission that we don't stop looking on the issue of uninsured and that we don't forget about the many Americans in this country who do not have access to health care, and the universal access to health care would essentially limit the debate of quality in health care to a great deal.

I want to make sure that we all do our part to make sure that that is not forgotten after we walk away from this table.

Thank you.

Commissioner Chao: I would like to thank the Co-Chairs, as well as Commission staff, and I hope in the years to come the Americans will enjoy the benefit of the Commission work.

Thank you.

Commissioner Hunter: I would echo all the appreciation of the Co-Chairs and the staff. It feels like one of those rare occasions in one's life to see people perform in just such a stunning, stellar way that it makes you feel good, or makes me feel good, to see the quality of work that has been done for this Commission. It's really incredibly impressive.

I think that we collectively had an opportunity to assess and try and identify issues facing the health care system as the health care system itself was at this point of transformation. And so, it seems to me like we've all participated in a very remarkable and singular kind of process.

I think the thing that I feel best about is that, given the limitations within which we worked, which were very real, I nonetheless feel that we collectively stepped up to the plate and did our best to really assess what could be done to protect consumers and enhance quality as the American health care system goes forward. And, I just hope that we can see as our legacy that this document becomes a reality for all Americans.

Commissioner Reardon: Thank you.

I, too, want to say what a privilege and pleasure it's been for me to work with the Commission, have the opportunity to work with the Chairs, who through their leadership I think, we've forged two very important documents.

Also, it was a time to again renew an acquaintance to Janet Corrigan, who I had the opportunity to work with several years ago and her very capable leadership, but also I want to thank Beth Docteur for her tolerance and understanding as we worked through our subcommittee discussions, which at times I think we needed some real direction, and she was able to help us with that.

I think the most impressive thing to me with this Commission is the diversity of the Commission as we came together, we were able to work through that, we were able to bond together and the collegiality developed, and forging two documents which will be one. One is the Bill of Rights and, of course, the second is the Quality Improvement, but it's truly impressive to me that the diversity of the group was such that we had a common goal, and that was to improve the health care system and work together, and I thank you for that opportunity.

Commissioner Sharfstein: I'm quite proud to have participated in this sub-process with you all, everybody in the room. It's been a fabulous experience.

I think that the shift of the debate from cost to quality is a very important shift. We've been so obsessed in the medical marketplace with the issue of cost, that there's been too little concentration on quality, and I think the Consumer Bill of Rights and this report on quality will really help make that change.

I had the opportunity in the '70s to actually work as a staff to a presidential commission, it was the Commission on Mental Health, so I have a great appreciation for the kind of staff work that's taken place, and this has been, I think, without question, some of the finest staff work that I've ever seen, and Janet and your entire group has just been absolutely wonderful.

I learned a lot from the two Secretaries, in terms of how to chair a meeting, and I will certainly take that away. That's been very important.

I will not be there tonight because my board, it's a Quaker board, is meeting in Baltimore, so I will be dealing with a different kind of consensus tonight. I'm familiar with the culture, but I will be there tomorrow and hope that we can figure out some kind of reunion at some point, when we can bring the Commission back together and assess the impact of this work.

Thank you.

Commissioner Georgine: Secretaries Shalala and Herman, we've worked together for a lot of years, and I've always admired both of you, and you certainly have proven that you really can do a job and do it well.

I chair a lot of meetings in the labor movement, and I couldn't -- I can't even match you, I tell you, you were really fantastic, how you get things done.

We tried for consensus, but we have really long meetings. But, I also want to say that Janet and Ann were just fantastic, Sandy and Gail, my two co-chairs on our committee, were really wonderful and patient, and we had some sticky issues.

When you talk about consensus, and when you talk about the accomplishments of this committee, a lot of people suspect consensus, but when you see what happened late this morning, early this afternoon, where we came to consensus on the ERISA issue, it just shows how people working together, who want to get the job done, and want to do the best they can, can really put strong emotional feelings in their pocket and do what's in the best interest of the people that we're trying to help.

And so, this has been a great experience for me, it really has, and I really can't -- I can't go beyond what everybody else has said, except to say that this job was necessary. I think that, like everyone else has said, that we've really done a great job. It's really going to be a good thing. I think that we have to get people, we have to work at it, and we have to get organizations and people to adopt the Bill of Rights, and we have to continue to keep doing the kinds of things that we talked about here today. It's not easy task.

I worked with the First Lady on her health care program, and I know what disappointment is, and this is from disappointment, this is real joy, and I want to tell everyone here that, as a little body in the labor movement, I think that you all have really been super great. I've learned from all of you, and I'm going to really treasure these two days out of every month that you took out of my lifetime.

But, thank you very much for having me.

Commissioner Malone: I'm privileged to even speak. I'm delighted to be here, and I want to thank, of course, our outstanding Co-Chairs. I think that if you feel elevated it's just because you really do outstanding work with us, we know that.

I believe that the work that we've done in this Commission has been centered around the consumer, and I think because we lined it up with the consumer I think there was plenty good room for everyone to be here.

I think, sometimes it's very hard to find space in a group especially of 32 people, 34 at times, and I think that because it was about patient care, because it was about consumers, that that created the space, and it created enough safety for people to be candid, and for them to be -- for me to be as straightforward and caring as we possibly could be.

I want to thank my subcommittee chair, Sheila Leatherman, who is not here today, and I have to tell you that I did not like the idea of being put on a subcommittee. I love to hear everything at the same time, and so I like large groups, and so, the idea of breaking down into smaller groups was not something that I just would move to with affection. But, I found that the subcommittees was really the place of stability, was really the place where I started to get to know the people that I worked with, and provided a foundation for how then to work with the rest of the Commission.

So, I believe that the subcommittee work was just so essential to what -- essential, Paul -- to what we are doing now, and to get to know that I can always depend on Alan to do just this superior intellectual stuff that also makes good sense and that, you know, I don't have to carry the piece about minorities and poverty because I know that, I'm carrying it anyway just because I live it, but I know that Sylvia is going to come through and be there for me on that. So, knowing that different folks are carrying different pieces meant that I had the privilege of looking at a certain piece, and so I want to send a special note of thank you to all my physician colleagues around the table who continually heard me say, "change that phrase from medical to provider," and the willingness, and the openness, to allow that to happen.

A big thank you for all the encouragement that was received and given in this meeting, but also outside. The Commissioners were very encouraging of each other, so just a big, big thank you and a real privilege to be here and serve.

Secretary Herman: Janet?

Executive Director Corrigan: Well, I can't say how nice it has been to hear all of the comments around the table, and I really feel like it's been my honor to have been able to work with each and every one of you. This has been a very enriching experience and a very satisfying one that I just can't imagine how I'm ever going to top. It doesn't get much better than this, it's been a terrific year.

I would like to thank both Secretary Shalala and Secretary Herman for providing the leadership that they did, and I have learned so much under them, working with them, and also, in particular, Secretary Shalala for talking me into taking this job.

There were a few moments when I did question that decision after that early conversation with Gerry, but we got over it, and we found the middle ground, and we found a consensus and moved forward, and I think that's really what this whole process was all about.

I also want to thank my husband, who has been taking care of the kids, and reminded me this morning that as of Saturday morning he's going fishing for an extended period of time, and Richard, in particular, who has just been a wonderful colleague throughout this process, and was always there on those nights at 5:00 when I said I have to get out of here at 5:00 because preschool shuts down at 6:00, and he would stay into the evening and we just couldn't have done it without him, and he's really just been terrific, as well as all of the rest of the staff, truly have been just wonderful.

The other group that I think hasn't been thanked here, other individuals that I just want to mention, and it's really as a result of this open process, you've probably now all noticed that there really is quite a following that this Commission has. There are individuals from every major association in town, as well as quite a few who come from out of town, and they have had a lot of input into this process. We've received written comments, we received phone calls, and extremely helpful input that I believe has made this document much stronger as a result of their input, and not only those who come from associations, but individual consumers who have written to us and provided their comments and direction, I think, to the process has really been very, very helpful.

Now, I need to turn for just a second, I know it seems a little bit odd, but to some of the housekeeping issues before I turn it over to Secretary Shalala.

We'd also like to thank our faithful transcriber, Corbett Riner.

(Applause.)

Executive Director Corrigan: He's been with us since the first meeting.

Special thanks also go to Terry Porterfield-Fisher, the Director of Conference Operations at Natcher Center. She and her staff have been crucial to the smooth running of the three meetings, and a couple of other issues.

The event tomorrow at the White House will begin at 2:40 in the afternoon. If the Commissioners would please arrive at the northwest gate, which is on Pennsylvania Avenue, and you should arrive by 2:00 p.m. Weather permitting, the event will be in the Rose Garden.

Secretary Herman: Bring your coats.

Executive Director Corrigan: Bring your coats.

And, for the dinner tonight, which is in Secretary Shalala's offices at the Department of Health and Human Services, that's 200 Independence Avenue, S.W., if you would please take cabs that's probably the easiest way to get there.

And, just after we finish the closing comments, we do plan to -- the photographer is going to be taking a picture, so if all of the Commission members would please come forward we'll be taking a picture up here at the end. That would be just at the end.

Secretary Shalala: I think, Corbett, if you can get away from work and you'd like to join us at the White House, we'd be delighted to have you.

(Applause.)

Secretary Shalala: This has been a remarkable process. Over the course of the last 12 months, this Commission has shaped a national agenda. I think that I said 12 months ago that we were going to have to be nimble to be relevant to the national debate. We have done exactly that, and do not underestimate, not simply the patient consumer Bill of Rights piece, but the impact the rest of the Commission document will have.

The process that we set up, the new organizations, will be just as important, because all of us were anxious, not just to take a snapshot of the health care system, but actually to be able to get out ahead of it and to anticipate some of the changes that need to take place.

I want to thank Janet, Richard and Ann. They have been absolutely first rate. This as good as it gets, in terms of quality staff work. I'm delighted that after I interviewed everybody I went back to Janet and said, tell me what it will take to get you to do this job, and then I convinced Richard this was the right career move for him at the same time.

We have far exceeded my expectations, and I want to thank every member of the Commission. Just to get me to sit still this long is an accomplishment, but it's been very good for me, and I'm sure it's been just as good for Alexis, to sit through these sessions and to actually consume new substantive information and to hear the debate in terms of the impact it will have on our leadership of our departments in the years ahead.

And, since within this Administration we control about a third of all the health care expenditures in this country, the fact that we can translate, particularly, the quality agenda, we've already moved on the Consumer Bill of Rights, into what we do every day, I believe that this Commission will have had a remarkable impact.

I want to thank all of the Commissioners. It has been just a terrific group of people. I knew about half of you before we got started, and it has been a wonderful opportunity for all of us.

Also, I have been conscious, not only of the decision-makers who we obviously speak to in our fundamental responsibility to the American people to take steps that will improve the quality of their health care, given the substantial resources that all of us devote to health care in this country, but I also want to say something about the people who work in the health care business in this country, people that get up every day and they work in Sylvia's clinic, they are nurses, and they are doctors, they are health care workers, they work in home care that Val knows very well, they work in skilled nursing facilities, they work in nursing homes, and they have been made by the changes that are going on in the health care system more insecure because they don't see where their futures are going to be in the business. And, there have been layoffs in different institutions, their roles have changed within health care, and I hope they'll see in this document a vision that will provide for those who choose health care as a profession, whether they are at the entry level, or whether they end up working at the highest levels of policymaking, opportunity for quality jobs and to be part of this quality movement.

I have been very conscious of them as we've been working through this document, and I hope they see hope in this document, as much hope as the American people do in what the outcomes are.

And, finally, let me say to my colleague, Secretary Herman, Alexis Herman and I have been friends for 25 years. We've worked on and off together, but never in a sustained way. It has been a pleasure and an honor.

As I've said to everybody, I thought the idea of two Cabinet officers devoting this amount of time was just not possible, but I think we both made it possible.

Our personal staffs at the Departments have been very much an integral part of these responsibilities to produce us and quality documents and to make sure we were very much engaged in this process.

So, Alexis, to you, it's been a wonderful partnership, and let's not volunteer again for the next couple of years, but we have a lot of follow-up that I think we're committed to together, and, again, I think the word quality applies to the Commission and to the staff, and to the President and the Vice President's clear idea that this could be done, that it was possible to push the field to make improvements for the American people.

Secretary Herman: Well, thank you very, very much, Donna, for your kind words, and thank you for your leadership. It certainly has been my distinct pleasure to have served with you through this great work on this Commission.

When you said 25 years, you know, I'm always reminding Secretary Shalala, we no longer talk about old friends anymore, we talk about friends now of long standing. So, she's been my good friend of long standing, and when she first talked about it we thought of this idea of a consensus model, we both looked at one another and said, you know, this is a real risk that we're taking, but given the caliber of the individuals that the President has asked to serve on this Commission it's a risk that is well worth taking.

And so, I thank you for, not only your courage and your leadership, but for investing the time in what has truly been a remarkable experience and a remarkable process.

I want to congratulate and thank also each of my fellow Commissioners. I've learned from each of you, you brought your own unique style and wisdom to this table, including your tenth grade teachers, and we thank you for that, Randy. And, Val, as you talked about the President's decision to appoint this distinguished group of national leaders, I could not help but travel back to my own days in the White House when the President was making that decision. And, you are right, there was literally a line around the White House for all of the individuals that potentially would have served on this Commission.

But, I don't believe that even the President in his wisdom could have anticipated the candor, the professionalism, the real quality of work that has emerged from the group of individuals that have served around this table.

It's fair to say that we've had constructive comments, we've had constructive criticism, but the real proof now, I think, is to make sure that we have real constructive action to follow, and we've laid out, I think, in this document a real blueprint for that to happen.

I especially want to thank you for living up to the spirit of this Commission in the final hours, in the final minutes. I said I was, perhaps, a bit premature in talking to both the New York Times and to the Washington Post at the break, when they asked the question of whether or not we do anything more with Chapter 10, and I said that, "Perhaps, I shouldn't say this, but I can't believe in the spirit of this Commission that we won't rise to this last challenge," and we did, and I thank you for doing that, each of you.

I also want to thank you as your Labor Secretary for the extraordinary work that was done, especially on the whole question today of health care workers that is so eloquently laid out in this document. It is a real contribution to the overall discussion of quality health care in our Nation today.

And finally, I want to say that as we conclude this final meeting, that I hope that you will see this as a very important and historical beginning, and not the end, because you have truly opened a new door for all of us into the 21st Century to make sure that we leave here, I believe, united in a belief that while we have a great health care system in this country, through this work of this Commission you have proved that we can make it even greater.

I thank you for that and now I want to invite each of you to come forward, not only for the concluding picture, but to participate in the transmittal letter that the Secretary and I will sign now to the President and to the Vice President of the United States.

There's one thing I didn't say, and that's to you, Janet, to you, Richard, and to this entire staff, you've heard it going around this table, but I want to say it also for the record from me, you've been extraordinary. You've been essential, you've been critical, and for the chairs of this Commission you have been medically necessary.

(Applause.)

(Whereupon, the meeting was concluded at 2:55 p.m.)

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