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Thursday, February 21, 2002 &
Friday, February 22, 2002



Friday, February 22, 2002 - Afternoon Session
  • Meeting Contents and Participants (10K bytes)
  • Thursday, February 21, 2002 - Morning Session (180K bytes)
  • Thursday, February 21, 2002 - Afternoon Session (251K bytes)
  • Friday, February 22, 2002 - Morning Session (304K bytes)
  • Friday, February 22, 2002 - Afternoon Session (277K bytes)


    Page 1

    A F T E R N O O N   S E S S I O N

    [Reconvened at 1:42 p.m.]

    Access and Delivery of CAM

    DR. GORDON: We are now up to the Access and Delivery Section. Linnea.

    MS. LARSON: We, on the Access and Delivery team, have been working on what the recommendations would address. How we looked at it was from a definition of, how do we define "access" for the purposes of this report, and how do we define "delivery" for the purposes of this report. Two criteria under access were, what CAM is available and what is affordable, and what are the models of delivery. Under "available and affordable," we recognized that we needed to address the issue of legal authority. Then we came up with a schema about readiness for licensure, emerging profession, and finally licensure issues.

    I think that was the schema. Out of that, then came these recommendations. Is that the logic of it? What is available and what is affordable.

    DR. GORDON: Tieraona, are you okay?

    DR. LOW DOG: I just wasn't sure why we were going through all that. We hadn't really done that for the other ones.

    DR. GORDON: The format for this section is going to be a little bit different. That is, that what is going to happen is Linnea presented, just in a few sentences, a brief schema. I don't know if there is anything more you want to say. Then we are going to go through the recommendations as we have for the other sections. The difference in this section is that the text is not as ready for prime time as in the other sections. So rather than a line-by-line critique of the text after we have gone through the recommendations, what I am going to be asking is general considerations, what should be included to ground and back up the recommendations that we are making; what others issues should be raised in the text; what issues have you seen in the previous text you don't think should be there.

    Everybody with me on this? So we are not at the same level of specificity with this section as we are with others, for a variety of reason.

    Page 2


    So what we will focus on, as we do in the other sections, is the recommendations. The text that will bolster the recommendations will be then written out of a variety of previous drafts that have been composed before, as well as about some new work.

    In the new work that is going to happen, both Maureen and Max Heirich, who is consulting with us, are going to work on developing that new text, and then they will get it to us as quickly as possible so we can all see it.

    Everybody with me on this? So the format is slightly different, but not that different for this section.

    So let's turn, first, to Recommendation No. 1 on page 5. It reads: "Access to qualified and competent practitioners, and to safe, effective, affordable CAM services and beneficial CAM products, should be improved for all Americans."

    Do you think it would be helpful if I read both Nos. 1 and 2 here, Joe and Linnea, or should we just start with No. 1?

    DR. PIZZORNO: I think, No. 1.

    DR. GORDON: Just No. 1, okay. So let's begin with No. 1, then. Under Nos. 1 and 2, the action items are really under No. 2 rather than under No. 1, Joe? Or, would you say they are under both Nos. 1 and 2?

    DR. LOW DOG: So, what does that mean exactly, that first recommendation?

    MS. LARSON: I am going to tell you a little history. This was written this way, I believe, to make room for an overall plan for legal authority. I think that is why it was written that way. What I see this actually saying, Tieraona, is let's redo the whole Commission report. I mean, it could be a little bit tighter.

    DR. GORDON: I would like to make a suggestion, that we read Recommendations 1 and 2, and the action items that follow, to give us a context, and then we can go back and reshape according to that, because then that gives much more latitude, rather than focusing just on this recommendation. Joe.

    Page 3


    DR. FINS: I think this is a leftover from the discussion about setting up the need for access. People said, oh, there are all these people that need access. I don't think this says anything that we haven't said 100 times, much better, elsewhere. I would just suggest that we go to Recommendation No. 2. I would just suggest, also, the framework that I think the text will have, once it gets done, of a micro-to-macro sort of perspective, that access is predicated on the ability to deliver services, and that there are three tiers: there is the practitioner level; there is the hospital, the community health center level; and then the health care system level, and that we are going to address regulatory issues that impact on the ability to provide access for those three tiers. So, with that in mind, I think I agree with Jim. Maybe if we went to the second recommendation, which really focuses at the first step on that ladder of the practitioner. Let me read it, and then let me say what I think we really meant to say.

    DR. GORDON: Let me read it, and then you can say what we really meant to say: No. 2, and this is page 9. I do think, Joe, I would like people to at least look at the action statements that follow, so they have a context. Julia?

    MS. SCOTT: I'm trying to say this coherently, but I will just say it. When I read this section, it looks to me as if Recommendation No. 1, the Action Items 6, 7 and 8 fall under No. 1, and Actions 1 through 5 seem to fall under Recommendation No. 2, which deals with practitioners.

    DR. GORDON: Yes, it does look that way.

    MS. SCOTT: I think that separation might make it a little easier to look at both these recommendations. Just a thought.

    DR. ORNISH: I have a somewhat radical proposal, which is that we just delete this chapter and be done with it.

    [Laughter.]

    DR. ORNISH: I'm serious about that. The reason is that, first of all, I think we are making so many recommendations anyway, that making fewer recommendations has value, but the major problem that I have with this chapter goes back to what we were talking about this morning. I mean, the first recommendation about having access available presumes that there is enough data that we should be advocating that. Issues of licensure and credentialing, and so on, are already covered in other chapters.

    MS. LARSON: No, they aren't.

    Page 4


    DR. FINS: That's just education.

    MS. LARSON: That's education.

    DR. ORNISH: Well, if we could maybe just take that part of it and put it into that chapter, and then just leave the rest of the chapter behind, it might be worth considering.

    DR. GORDON: There is a suggestion on the floor. Are there responses, at this point.

    MS. SCOTT: I guess I would just like to go on record saying I am on this task force, but this is so foreign to me, what is here, when I remember all of the things that we recommended, demonstration projects and community health centers for low income people, and whatever. So I am almost on a wavelength with you, Dean, but I don't, I really don't feel that access has been dealt with in the other sections.

    DR. ORNISH: What about incorporating it into those sections?

    DR. GORDON: Maybe if you could clarify a bit for people.

    DR. GROFT: I think what was attempted here was to take this section and put it into the format of the rest of the report. Due to a series of circumstances, it did not come off well, obviously. So I think the approach that we were trying to take today is, let's go and look at all the recommendations and actions, see if there are areas of agreement that we can reach, then build from there.

    We feel that there is probably sufficient information on previous versions of the document that we can then bring them in, get it out to you, and then have a telephone conference where we can discuss this, probably over a two-hour session. I am asking a lot here, because this is so convoluted from where we were at the December meeting.

    Again, attempts were made -- it was so long and the recommendations were all at the end -- trying to bring the recommendations and the action items back up into the report, closer to where the subject material was actually discussed, again, to try to bring some consistency, and we obviously failed. I think, now, trying to salvage it in a way that it will make sense and still get the points across that we would like to make, or you would like to make, I think we should make an attempt at it.

    DR. GORDON: Tieraona.

    Page 5


    DR. LOW DOG: I think that, again, this was one of our executive charges or whatever. We were supposed to deal with this, so we have to deal with it. I think a lot of us are sort of shell-shocked because the text is really problematic. The point is what we have come back to again and again and again, before you can assure access, depending upon what you mean for access -- people accessing versus reimbursement and what you're paying for -- you have to have some sort of evaluation of what people should have access to. So we have sort of skipped through a lot of that. Like the first recommendation, if we are talking about that one, even with or without the second one, we are talking about improving that for everyone. I don't even know what that means. I just think that we need to step back again, and we need to have recommendations that talk about evaluation and who is going to do the evaluation, get back to the demonstration projects that were originally in there, et cetera.

    DR. GORDON: Dean.

    DR. ORNISH: I completely agree with what Tieraona is saying. Steve, while I think that if we had more time, your idea makes perfect sense, we don't. The idea that in a two-hour conference call, we are somehow be able to fix this, even talking about it today, I think is overly optimistic, particularly since we are going to be getting the entire report fairly soon that we are going to have to go through, and a lot of us are doing a lot of other stuff, too. So if we could just take one or two key issues here and somehow combine it into another chapter, I just think that is a much more practical goal.

    DR. GORDON: Joe, go ahead.

    DR. PIZZORNO: As Tieraona said, No. 4 in the directions we received from the President was quite clear that we are supposed to be determining how to improve access to safe and effective alternative and complementary health care. Clearly, a majority of this health care is being provided by CAM practitioners. Our job is to make sure that health care that is being provided is as high quality as we can. We have, right now, in the country, a situation where we have licensing and registration of CAM providers, and we have already received data that shows when they are licensed and registered as appropriate, we have a safer practice. We have a lot of people out there who are claiming to be CAM practitioners who do not have credentialing and for which we already have data that they are not safe and they do public harm. We must provide guidance to Congress and to the states to differentiate between these two groups of practitioners; utterly critical.

    DR. GROFT: And to mention, too, I think, as you can see from the table, Max Heirich is here, who we have brought on board as a consultant to the group to help us. Maureen and Gerri, Corinne and Joe, we have all agreed that whatever needs to be done, we will do to bring to you the best possible section of this document.

    Page 6


    DR. GORDON: George.

    MR. DeVRIES: Well, first of all, I think a lot of good work has been done here, and I really appreciate the work of the committee. It shows a lot of effort, and there is information here that I think is important to make sure that is in the Final Report. I think maybe the comment that I would make that I think a couple of others have made -- and I really don't think it is going to take that much time, and we have an external consultant now to help us -- but we need to go back and we need to look at it, and perhaps put it into a format that more reflects the format that we have seen in the other chapters, so far, of the report, and that seems to be working pretty well for us. There is a lot of good material here. Some reformatting and some editing would probably help in getting it more like the other chapters, but it is important to have its own separate chapter. Again, the Executive Order. I don't need to repeat it, but I think it is important that it be in its own chapter.

    DR. GORDON: Joe, and then Tieraona, and Julia, and Joe.

    DR. PIZZORNO: I wonder if it would improve things if we simply eliminated Recommendation No. 1 and just go to Recommendation No. 2, because I think Recommendation No. 1 is pretty vague, and it could be interpreted a lot of ways, some which we may not want. Whereas, Recommendation No. 2 gets to the whole issue of safety and access.

    DR. LOW DOG: Well, I would be open to the dropping of Recommendation No. 1, sort of keeping that as an option thing there. I was just going to talk about a process issue so we can keep moving, that perhaps we should just dive in here and just start looking at this recommendations and seeing what we think.

    DR. GORDON: I would like to hear just a couple more opinions around the table, and make sure they get out, and then we will move in. Julia.

    MS. SCOTT: I am just very uncomfortable with this section because of what I see as an over-balance of recommendations having to do with the credentialing of practitioners. I am uncomfortable with that, and I think it probably should have been dealt more with Education and Training, but I want to see a balance in this section that not only deals with the practitioners being credentialed with access/delivery issues involving consumers, and the protection of consumers. There is not a lot to work with with what is here.

    DR. GORDON: Conchita, you had your hand up. I'm sorry.

    MR. PAZ: I was very much concerned about the access -- or, actually, the delivery part as well, because I didn't think that part was developed very much.

    Page 7


    DR. GORDON: Joe, and then Effie.

    DR. FINS: I think that the one thing here that is most valuable, and would be valuable to the states -- and one of the reasons recommendations were not as readily makeable in this situation, was a lot of the regulatory questions related to practitioners devolved to the prerogative of the state. So I think what we see on pages 7 and 8, sort of the taxonomy, is a guide, really, for states to take under consideration. One action item or recommendation that I think follows from that, and we heard this from Max and other folks, is to maybe look at his study, what the experiences have been, based on the different models that have been adopted in various states, and how it relates to consumer protection. I would add consumer protection is covered in the Information Section under DSHEA and labeling, and so it is elsewhere as well. I also think it is important to state, and Joe Pizzorno and I were talking about this, that it is necessary, that one of the linchpins in our analysis -- and I must say that this document doesn't reflect where we were, I thought, after our December meeting -- was the issue that the ability to practice has a real impact on access. So that, the focus on practitioners was because we had a lot of testimony and saw a lot of data saying that if you don't have the ability to practice in a jurisdiction, then all the people don't have access to your services. So that's why that relationship is there. Maybe it needs to be expressed more clearly, but that's why the focus was on the practitioner side.

    The eventual idea was really to go up and deal with hospital and clinic/community health center issues and demonstration projects there, and then up to health care delivery systems and how managed care systems integrate, and all that. I would recommend the staff go back and look at the December draft, because I think a lot of that was in there and it has gotten cut out as this gets reworked.

    DR. GORDON: Effie.

    DR. CHOW: I appreciate what Joe just explained, but I just wanted to say that I feel very strongly, too, that this is heavily overloaded with licensure and registration. That part is important, but the accessibility by locale, and by availability and dollars, and all that, accounts for people being able to use the facilities.

    DR. GORDON: Any other general comments? I want to try to summarize what we have heard so far. Wayne, did you want to say something?

    Page 8


    DR. JONAS: I just want to point out that, at least to the degree that licensing and credentialing is concerned, it is really only indirectly related to research. Most of it is about competencies, professional standards, and that type of thing. I am talking about conventional medicine. So those things have to be addressed, but to put it in a framework of, access is dependent upon established safety and efficacy to practitioners is a confusion of categories.

    DR. GORDON: Let me say a couple things that I am hearing, and let's see if we are all hearing the same thing. One is that the chapter is not in anywhere near the shape that we would hope it would be in, No. 1. No. 2 is, there is a lot of information from previous drafts that could make it much stronger and much more coherent. No. 3, that there is a sizeable concern of people who feel that there is an overemphasis on regulation and licensure, and not nearly enough discussion about access from the consumer side.

    So here are some issues. Max, as the consultant, and admittedly as one who hasn't had a lot of time, I'm wondering if you have any kind of general schema that you think might help to resolve some of these issues, both the concern about what has been left out, the improper development of the argumentation for regulation that just has not been in this draft, and the concerns about consumers.

    Is there a way that we can put it together? I have a fundamental question, should we look at this now, or should we take another kind of leap and allow a group of people to work on this and then give it back to us in a slightly different form in a couple of days.

    I am not crazy about that option, but I don't want us, also, to make ourselves miserable by going through something and just feeling incredibly frustrated with it. Anyway, Max, please go ahead.

    DR. HEIRICH: Well, I am going to be answering off the top of my head because I just took on this assignment about 15 minutes ago. It seems to me that the format for the chapter, it would be very important in the text to lay out clearly the range of issues that need addressing, the incomplete state of evidence for resolving them and the need for a strategy to move forward. One could then, as was just suggested, say that there are several levels which are important to consider. We need to look at the level of access to individual services, the access at hospital/clinical/community center concerns, access for the system as a whole. After we set that kind of framework of what needs to be done -- and I haven't seen the earlier draft, so I don't know what is useable within them -- we could then discuss the recommendations within that kind of framework.

    Page 9


    DR. GORDON: The question I want to raise is -- and Joe, you in particular, and Linnea -- should we do our best to address the recommendations now?

    DR. FINS: I think if we can salvage some of them, that the text then could be built around those recommendations, but I think we should go through this and not be wedded to the recommendations, because they, too, have more. No one, I think, is really necessarily wedded to the way they are written right now.

    DR. HEIRICH: I would like to suggest that there may be additional recommendations that will emerge from this discussion.

    DR. GORDON: Let me make a suggestion based on the comments that have been made, that we read Recommendations 1 and 2, and Action Items 1 through 8, and then we go back and begin to address, because that way we will cover a fair amount of the territory. Maureen?

    MS. MILLER: I just wanted to comment, I think that would be a useful way to spend some time, as long as everybody understands that once we work on this and absorb this, that the recommendations might be slightly different. I'm hoping Max will agree with this, I think that it would be helpful to have a sense of the Commission before we leave and do this work.

    DR. HEIRICH: Absolutely.

    MR. PAZ: The only thing is, once some of the text comes out from earlier stuff, that this may not be all the recommendations.

    MS. MILLER: Exactly.

    DR. LOW DOG: I just have a process issue, since this is going to be done by a conference call, because everybody has committed to be here during this time, and I know a lot of us have travel and stuff, that I would certainly hope that there is going to be real accommodation made, because this is one of the toughest sections that I personally had the most problems with. I am not going to be very happy, after making the time to be here, if now, days later, I am not available for the conference call.

    DR. ORNISH: Yes. I feel the same way. I agree. If we're going to do it, we might as well do it. I just cancelled my flight, too, and I would feel really dumb if we just postponed the whole thing. So, why don't we get as far as we can with the current recommendations. If there are more recommendations later, we will deal with them at that time, but at least we can deal with what is in front of us.

    DR. GORDON: Steve.

    Page 10


    DR. GROFT: We will try to get a time in which all of you are available. I can't make a guarantee that 19 Commission members are going to be available at one time, but I think we have to get as close as what we can on the recommendations. We have spent a half hour here. It is important to do this, so I think if we can get moving on them now, do the best we can, and even if it's a weekend where people seem to be a little bit more available, or an evening, that we can get people, that's what we will attempt to do. Hopefully, by Thursday we will have something ready for you to look at, Wednesday or Thursday.

    DR. GORDON: What I would also like to say is, to get a commitment that we will work on this now, and if need be, we will spend time on it after Public Comment as well. So we can do as much as possible while we are together, and then, I think, go to Reimbursement, which I think we would generally agree is a section in much better shape. Can I have that commitment? Good. I think that the best way to get a view of the territory in the beginning here is to read both recommendations and read all the action items. Everybody take a little time. Recommendation No. 1 is on page 5, and Recommendation No. 2 on page 9.

    [Pause.]

    DR. GORDON: Let's begin. Joe, did you want to begin?

    DR. FINS: Just big picture structure. I think Julia's idea is something that we really should just adopt as a placeholder here, that the Action Item 6, No. 6 certainly, and No. 8, are ones that look like, what is the demography of the need and what is the need for the workforce out there as the first thing. I think, on Recommendation No. 1 --

    DR. GORDON: I'm sorry, you didn't finish your sentence, that those two go with Recommendation No. 1.

    DR. FINS: I think, in the beginning. They don't necessarily go with Recommendation No. 1, but the issue to know what the workforce is. How does the workforce relate to access, is the first question. Then the question is, what is the workforce, and where are they, and how are they distributed. Those are questions that Action Item 6 would answer, and would be a predecessor to intelligent policymaking downstream. So that would be, I think, a good place to start, sort of diagnostics versus therapeutics; let's diagnose the state of the problem.

    Page 11


    Recommendation No. 1, in my view, is overly broad, vague. We are talking about practitioners and services and products. I have said this before, this is about practitioners here. We deal with services. We deal with products elsewhere. Services are often related to the practitioner. It is really about, here, the licensing of individual practitioner types, at least in this section. So I think products is something that shouldn't be here, because we deal with it in other places. Or, if we are going to deal with it, we should deal with it as a separate recommendation because there are enough specific issues about that.

    DR. GORDON: Yes, Tom. Tom, Dean, George, Conchita, so far.

    MR. CHAPPELL: I agree with Joe. We are dealing with the product issues significantly elsewhere, and it does confuse things to have it here.

    DR. ORNISH: I also agree with Joe, and I would take it even further and say, look, what question are we trying to answer. To me, the question is, how can I know that the CAM practitioner is qualified and competent. I mean, that is, to me, the most basic question. Then the next question is, how can I get access to people who are competent and qualified. But the first question is, how do I know that someone I am going to has any kind of licensure, training, qualifications, credentials, and what are they. Of course, then the question is, what should those credentials be for somebody. I think that's the first tier. The second tier, then, is, how can people get greater access to whomever those people are. So I would like to focus just on narrowing this down to how can people in the general public know if somebody is qualified, what are the standards, and what should they be.

    DR. GORDON: George.

    MR. DeVRIES: I think, on Recommendation No. 1, there has been a tendency to want to underplay the recommendation concerns of states rights, because that is ultimately what this comes down to. I am going to suggest that we reword Recommendation No. 1, and that we go consistent with other recommendations we have in the report. It might be something to the effect of: The Commission recommends that states provide adequate licensure, registration, certification or nonregulation of providers, consistent with their scope of practice and education, something like that, which I think goes right to the heart of the matter of what is in Recommendation No. 1, which is really talking about making sure providers are appropriately licensed, certified, credentialed, consistent with scope of practice and education.

    DR. FINS: Jim, may I answer?

    DR. GORDON: No. Let's let everybody talk, and then we can come back to you, Joe. Conchita.

    Page 12


    MR. PAZ: I agree with that. I think we need to separate out the providers, or the practitioners, and we need to separate out the products. Even though we have talked about products, we haven't talked about access to the products.

    DR. GORDON: So you're saying products ought to be a separate section within this.

    MR. PAZ: Yes.

    DR. GORDON: Okay. Effie.

    DR. CHOW: I think Recommendation No. 1 is a broad, general statement. Action Item 6, 7, 8 goes more with Recommendation No. 1, and I would move that to the beginning. I am a little bit confused that we have both recommendations and then the actions after the two recommendations. So that is what I would recommend. I do agree that services and products should be separated and dealt with accordingly.

    DR. GORDON: Any other comments? Don.

    DR. WARREN: Didn't we hear about the House of Lords report that said that licensure did not guarantee competent treatment? Isn't that right? I am wondering why we are worried about licensure at all. I think we ought to be licensed in our respective professional fields as dentists, chiropractors, NDs, DDSs, the whole gamut -- excuse me, DOs, and then have registration as the alternative. Licensure of a CAM practitioner is not going to guarantee competent care. It is not going to guarantee access.

    MS. SCOTT: Again, I hear the focus going on the practitioner, and if we are dealing with the practitioner first and then going to get to access to the consumer, and delivery to the consumer, I am fine with that, but just licensing or credentialing or registering the practitioner does not ensure that the consumer is going to have access and delivery. I want us to keep that in mind as we are looking at this chapter.

    DR. LOW DOG: Don, what in Recommendation No. 2 doesn't address your comments? Because this says accountability to the public, and contains provisions for registration, licensure, and exemptions, so that there is room for all of it.

    DR. WARREN: Well, when they put "licensure," in there, next to it I put "no," the entire recommendation. I just don't believe licensure should be part of it.

    DR. LOW DOG: But there are CAM practitioners that are licensed, so shouldn't there be --

    Page 13


    DR. WARREN: Are they licensed as CAM practitioners? "Naturopaths," they are licensed in how many states? But they are not licensed in Arkansas. So a CAM practitioner or a naturopath in Arkansas is practicing unlicensed. Patients still have access to them.

    MR. DeVRIES: They don't.

    DR. WARREN: Oh, yes, they do.

    DR. LOW DOG: They still can go.

    DR. WARREN: They can still go. That is access, isn't it? They just don't get it paid for, except out of pocket.

    DR. GORDON: Let me just say that what we are doing here is very important, and what I want is to make sure that everybody's general concerns get heard, and that will enable us to focus more on the specifics. So Don has expressed his concern. He has pointed out that at least in his state licensure is not what is happening for some of these CAM professions. So we will keep going around. Joe, and Dean, and Tom.

    DR. PIZZORNO: Don, I think it is true that there is some access to some aspects of CAM services in states with no licensing, but it is a significant problem. One is, they can't practice their full scope of practice. Second is, they can't differentiate themselves from other health care professionals. Third, they can't diagnose and prescribe. I can go on. Of course, there is the whole issue of reimbursement. So what happens is, in those states you might get one or two who show up who have proper credentials, but those with credentials will go to states with licensing because that is where they can actually do their scope of practice and have a defined practice right for their patients. It does not work.

    DR. GORDON: Dean.

    DR. WARREN: Would registration not accomplish this? I still don't like licensing.

    DR. GORDON: This is important. It is important that we have a common understanding of some of the issues. Dean.

    DR. ORNISH: Well, I think it is important. I remember one of the people who testified before the committee, saying that basically anybody should be free to practice any kind of CAM, no matter how they define it, no matter how unproven, no matter how safe, as long as they disclose what they are doing. For myself, at least, I am really uncomfortable with that. It is not just a question of access. I would like to take a stronger statement, in the spirit of the other discussions that we have been having that I think will ultimately give our report a lot more credibility, is if we talk about the need to, not just limit licensure, but even the practice of certain types of modalities or approaches to those that have at least some evidence of safety and efficacy, recognizing that that is going to be a real problem for some people who say, gosh, I have been doing this for a long time; and, why should I have to submit to those kinds of standards. I think if we are talking about protecting the public, we need to perhaps consider a stronger statement about, not just licensure, but even access.

    Page 14


    DR. GORDON: I want to point out something that I think is an important part of the discussion that got left out of this draft, but that has been there previously, that there are experiments underway, including one that we heard a great deal about in Minnesota, where exactly that principle is there. The belief on the part of the state is that registration, with the opportunity to register complaints about registrants, will be effective. What I think is that it is important for us in this report to take account of these natural experiments that are underway, and to think through why we are making the recommendations that we are, and at the same time, to acknowledge and have a respectful attendance to what is happening with these natural experiments. I am not saying where we should ultimately come down, I am saying that we need to look broadly at the terrain and understand that we have observed what is going on. Tom, and then Tieraona, and Joe, and Don.

    MR. CHAPPELL: I think one of the goals of this whole section is to understand how a consumer can translate competency or the standards of the professional. We found, in our work over the last two years, that the professional associations that set standards for themselves, and ongoing training and so forth, was the best source of competency and standards. I recall our feeling that we are powerless over the states' control on these issues, but that we really could draw from the experience that each professional association had gone through over time to raise up the standards of their membership.

    DR. GORDON: Tieraona.

    DR. LOW DOG: I think you raise a good point about the different models, if you will, that are currently underway. I don't think anybody has really evaluated them. I hate to come back to evaluation, but when you are looking very different models, such as Minnesota or what is going on in Washington State, they are very, very different. I think at this point, nobody really knows how it is going to turn out. So perhaps, someplace, in a recommendation, an action item, someplace, maybe it should be, at an appropriate time for the evaluation of these different models, to see what works and what doesn't work, to try to determine what is the best path.

    DR. GORDON: Joe.

    DR. FINS: I agree. I think is in the spirit of the rest of the report that there are questions that we don't have answers to. We have identified a problem. I think that what we have offered here is a framework for states to consider. One of the action items should be to protect the public health, funding should be made available, perhaps, to the states from the federal government through the health care or health professions, or HRSA, or the appropriate agency, AHRQ, to evaluate the various regulatory patterns that exist, from the libertarian Minnesota model to ones that might be more stringent. I know that Minnesota's model would never work in New York. That is because it is different and we're different.

    Page 15


    DR. GORDON: We do know that. Effie.

    DR. CHOW: Starting on page 11, "Delivery Issues Affecting Access to CAM," speaks to some of the concerns that I think we have spoken about and are central to my heart. Some of these are finances, proximity, professional practitioners, quality of the location, the facility, the quality of care, and safety, of course, and the language, and then knowledge by the people, or having knowledge or having access to information that tells them about the program. We don't have a recommendation here that speaks to those points. All of it has been on regulation and licensure.

    DR. GORDON: I'm sorry, can you summarize the points, Effie, that we don't speak to?

    DR. CHOW: Well, there is something here about "cannot afford to pay out of pocket," and so forth. What I am saying is a recommendation doesn't speak to these points that are missing, considering the finances of the individuals, the proximity of the available services, the professional practitioners, having available professional practitioners there, and the quality of care, and safety of care, of course, and then language considerations, and then the information and knowledge that is available for people.

    DR. GORDON: So what you are referring to is a number of specific issues that may affect access of people to services.

    DR. CHOW: These all affect access. Of the people, yes, and there is no recommendation that speaks to that.

    DR. GORDON: And you would suggest that there should be such a recommendation.

    DR. CHOW: Yes. There are some things that are stated here, from page 11 to 13, and so forth.

    DR. GORDON: Any other general statements? Charlotte, Wayne, and Conchita.

    SISTER KERR: I just want to comment on what I think is an emphasis in some of the actions, or maybe the spirit of some of this. I wonder where we individually feel. Before you look at the whole issue of access and delivery, and particularly under Action Item 2, there is this statement that the federal government, and it does say, "In collaboration with states, CAM practitioners will work on a definition of professions and practice." The point I want to make is, it seems to me -- this may not be the best thing -- but self-regulatory and federal government working on defining CAM rules and regulations is an issue. For me, I can't think of any medical school or school of nursing who would go to the federal government to say, help us work out our guidelines for directing our profession. This seems really puzzling to me in here. Thank you.

    Page 16


    DR. GORDON: You are expressing a concern about federal intrusion into regulation of these professions. Wayne.

    DR. JONAS: I think that this is an area where the federal government does not have a lot of direct jurisdiction. They can have indirect jurisdiction by helping to facilitate producing guidelines and things like this that are then used by the states. I think this can be a very helpful win/win situation. I have a question for those who worked on this. The relationship between this and the Access to Medical Treatment Act, which has been evolving and circulating for a number of years now, and has looked at and developed a variety of sets of guidelines in terms of assuring safety, competence of the practice, and freedom to choose. Can someone speak to that? I didn't really see that referenced. I didn't see the same language, and yet that seems to be dealing with a lot of these same issues and is directed towards the consumer, not the practitioner, per se. Can someone comment on that?

    DR. GROFT: It may have come up at one point in time. Because it was proposed legislation, and not enacted legislation, I think the decision was made that we really weren't going to address that specific piece of legislation.

    DR. JONAS: I am not asking that it be addressed specifically, but I mean, here is a whole body of effort that has gone in, several years, trying to do the very same thing. I am just wondering if that was used as a consultant.

    DR. GORDON: Wayne, you are suggesting that we need to include that.

    DR. JONAS: Well, I think that needs to be looked at, because a lot of people have worked on that for a long time in terms of trying to figure out, how do you address access and maintain safety, et cetera, et cetera. I am not saying that that is the way it ought to go, but I am saying that here is a whole thing dealing with access that isn't a licensing issue, per se, that should be evaluated.

    DR. GORDON: What we are doing now, and you are doing it very clearly, and others have done it, is we are raising some of the issues that need to be addressed in this chapter. Conchita, and then Tom. Then I think we need to, pretty soon, as we come to a conclusion with general statements, start focusing on the recommendations and where we want to go with them.

    MR. PAZ: What I wanted to emphasize was, in the spirit of trying to promote the CAM practices in states that have no licensing or registration, it possibly may be antagonistic if the state is having some snags in trying to develop their criteria, or giving some major resistance to it, I think that is where they can enlist the help of the federal government to try and facilitate that type of development. I think No. 2 is pretty succinct in saying that.

    Page 17


    DR. GORDON: Tom.

    MR. CHAPPELL: I don't see what value we will be able to add to the state licensure issue. So that, I feel that our recommendations ought to be where we can add value, make a difference and so forth, as I mentioned earlier in my last comment. I also just wanted to say goodbye. I have to leave now, and I wanted to thank you all.

    DR. GORDON: Thank you, Tom.

    [Applause.]

    DR. GORDON: We will be in touch. So, with all these things in mind, let's begin to see what we can do with the recommendations and the action items, see which ones are appropriate, how they may need to be altered, what might need to be added, and then having heard the shape that the Commission would like the chapter to have, we need to come back to it. So let's, then, move ahead. George.

    MR. DeVRIES: Can I go ahead and just start on Recommendation No. 1?

    DR. GORDON: Yes.

    MR. DeVRIES: First of all, just a couple of quick comments. Tom's comment, just as he left, what value do we add, we add tremendous value. It goes back to the fact that there are 50 state legislatures who are trying to manage and regulate health care, and this is a federal body that can make tremendous recommendations. The second part of this is that, many of you are medical physicians or dentists, and you have your license and you are able to practice, you are able to practice your professions, but there are other professions out there, and the naturopathic is one of them, where they only licensed in 11 states.

    When they are licensed, their scope of practice or education says that they can diagnose a condition, that they can treat a condition. If they don't have a license, if they go to the State of Arkansas and do that on their own, they are basically practicing medicine without a license. So the license really gives them the ability to practice. That is why it is our ability as a White House Commission to make a recommendation to the state. I think this committee has done just a superb job balancing all the issues, from the exemptions, those like the Minnesota law, allowing there to be flexibility in the system, up to saying to states, it is important for a profession like a naturopath or acupuncturist, these people who, their education, their scope of practice is such that they diagnose medical conditions, they treat conditions, they need to be licensed. That protects the member, but it also allows the provider to practice their profession.

    Page 18


    So I want to say that on the front end, that really I believe this is just a critical part of the report to keep in. I still go back to an earlier recommendation I made in terms of Recommendation No. 1, changing the wording, being more direct. I support leaving in what has been done here, and splitting out the products, perhaps, into a second recommendation, and really letting this focus solely on the ability of the provider to be legally empowered to practice their profession. Now, I say that with the caveat, Julia, I support 100 percent that this section needs to be balanced with facilitating patient access to services, too. So this is just a part of this Access Section.

    DR. GORDON: George, do you want to repeat the wording you had for Recommendation No. 1.

    MR. DeVRIES: Sure. Sure.

    DR. PIZZORNO: Could I ask a question first, George? The wording you came up with sounded more like a recommendation for No. 2, rather than for No. 1.

    MR. DeVRIES: Okay.

    DR. PIZZORNO: Because No. 2, I think, is more about the credentialing. I think No. 1 is about the access issues that are independent of credentialing.

    DR. GORDON: Do we want to begin with No. 2, or do we want to begin with No. 1? Wayne?

    DR. JONAS: I'm not going to answer that question. I had a suggestion that is different.

    DR. GORDON: Please, give us your suggestion.

    DR. JONAS: I would like to suggest a modification of these recommendations along these lines, my suggestion is that we start first with, not licensing and credentialing, but we start as our first recommendation with a recommendation that looks at access directly to the consumer. I would suggest that the action items that are at the end, actually, are the ones that address those, more than the ones at the beginning. So those should be moved up front. I don't have a lot of problem with those action items as they are written, but I think they should be framed with an actual recommendation that goes over them that might go something like that, and addresses specifically looking at the barriers to consumer access, again, to safe and effective, and to qualified practitioners.

    DR. GORDON: Is one of the staff taking down this? Yes? Okay, good.

    Page 19


    DR. JONAS: And here is some suggested wording for a recommendation that I would say would be No. 1, and these would follow as action items, and perhaps they could be modified: The federal government should evaluate current barriers to consumer access to safe and effective CAM practices and qualified practitioners, and develop guidelines for removing those barriers and increasing access. So this is a general recommendation. It is directed at the federal government. They are looking at the barriers, focusing on safe and effective practices, and qualified practitioners as the initial focus.

    DR. GORDON: That, then, would be a replacement for the current Recommendation No. 1.

    DR. JONAS: Correct.

    DR. GORDON: Repeat it again, Wayne, so everyone can hear.

    DR. JONAS: The federal government should evaluate the current barriers to consumer access of safe and effective CAM practice, and to qualified practitioners, and develop guidelines to remove those barriers and increase access. Then the action items, Nos. 6 through 8 actually largely address that.

    DR. GORDON: I would like to have discussion on this substitute recommendation that Wayne is making. People's responses to it? Charlotte.

    SISTER KERR: I just want to complement that. I think in the case of the wording of this recommendation, I agree with the role of the federal government to do that.

    DR. GORDON: Julia.

    MS. SCOTT: I like Wayne's. I was trying to get some language together, and I like what he has done with that recommendation. What I would add is that, while Nos. 6, 7, and 8 seem to go under that, perhaps with a little rewording, there are additional action items that need to go there.

    DR. GORDON: Thank you, Julia. Effie.

    DR. CHOW: I just want to thank you, Wayne. That was the recommendation I was saying was needed. Thank you.

    DR. GORDON: Dean.

    DR. ORNISH: Well, I don't want to sound like Eyore, but it just sounds like there is a greater body of evidence that these various practitioners are effective than, I think, exists for most of them, and that we should therefore try to really knock down those barriers and open the floodgates to people, when I am not sure that for many modalities that we are even close to that point.

    Page 20


    DR. JONAS: That's right. I mean, it may turn out that there is only three, but I can tell you that I know I have made many attempts -- and I am licensed -- to get acupuncture available for chemotherapy-associated nausea and vomiting, proven safe and effective, et cetera. Cannot do it. There are barriers to that. We need to examine those. I can tell you there about a half dozen, at least, herbs that have good evidence that they are safe and effective for a particular clinical condition. So I think the issue is that we ought to examine those. That is what this is for. I would suggest that there may not be a whole lot, but there is probably enough to actually address this issue.

    DR. ORNISH: Is there a way to somehow put language in there that is a little more modest in terms of recognizing what you're saying? Tieraona, do you have any thoughts about that? I'm just curious.

    DR. LOW DOG: Well, I think, again, if you're talking about evaluation -- I guess my main concern is evaluation of barriers -- and that is the only thing you're talking about.

    DR. JONAS: So you would add opportunities with barriers and challenges?

    DR. GORDON: Wayne, and then Effie and Joe also have something to say. Do you want to say something at this point?

    DR. JONAS: Well, I was going to suggest that we pair access with accountability in each of those statements that I mentioned, so that they look at barriers, not only to access but barriers to accountability, to assuring accountability.

    DR. GORDON: How would that sound, Wayne?

    DR. JONAS: It would sound cumbersome, but I think it would address the issue that this is not just about, give me more, give me more, but what we are doing is making sure that the practitioners that are delivering this, and the practices, are accountable, that they are addressing safety issues.

    DR. GORDON: I'm sorry, I want to hear from Effie, and from Joe and Buford.

    DR. CHOW: In our discussion it seems like the interpretation of these recommendation are for immediate action, and we are talking about short-term and long-term, because these are recommendation for change into the future, way into the future, and not just these next years. So therefore, it might be just three now, but it lays the groundwork for others as the research is proven and so forth.

    Page 21


    DR. FINS: I think the issue about removing the barrier presupposes that there is efficacy, and all that stuff, but if we look at Action Item No. 6, and we took part of that, I think it gets the spirit of what Wayne has just said, and what Effie just said about current and future, and says, "HHS and other appropriate federal agencies should seek to identify current and future health care needs or access that qualified CAM practitioners may address." Then they should seek to remove barriers that preclude their provision of things that have been deemed to be safe and effective and beneficial, and then we should get data, workforce data, national surveys, et cetera. Then the other action items sort of follow. The point is that you want to try to identify current and future health care needs that this workforce might address.

    DR. GORDON: Buford.

    MR. ROLIN: Thank you. My concern is with Action Item No. 8 here, this whole issue of traditional healing, and the recommendation that the Secretary should identify common uses and practices of indigenous healing in the United States, and on down where we are talking about dealing with the issues of how to protect cultural heritages, and things of this nature. We had some real discussion on that many times, and I don't think that captures the original statement that we had come up with.

    DR. GORDON: Can you redraft it the way you think it should be?

    MR. ROLIN: Well, we had some language there before, and I thought it was acceptable, and this has been tweaked.

    DR. GORDON: And the difference between that language and this language is what?

    MR. ROLIN: Well, the difference is the approach here, I guess, in the matter of saying the Secretary should. I don't know, in the case of American Indians, if we are going to ever get to the point of where we are going to share our cultural heritage and what is happening in that process. That is what I am concerned about.

    DR. GORDON: Maybe if you could take a minute while we are talking about some of the others, or at some point say how you think it should be written, because nobody is wedded to the exact form of any of these recommendations or action items. So if you make a proposal, that would be very helpful.

    DR. LOW DOG: Buford, I think part of the problem here as well is this sort of invasiveness of coming in and expecting people to share rituals, song, practices. Also, the feeling amongst many peoples that they have just about been researched to death, and they are sick of it. I don't think this is what it is getting at at all.

    Page 22


    DR. GORDON: Tieraona, I would like it rewritten in a way that feels appropriate. I think we're ready for that, we're up for that.

    DR. LOW DOG: Where is the language from the last one? Do you have that in your pocket, Julia?

    MS. SCOTT: I do, but it's at home.

    DR. GORDON: I think Wayne's substitute recommendation for No. 1 is very appropriate. If there are three or 30 that are safe and effective, the point of it is it provides an avenue, it provides a rationale that is well within the approach to scientific medicine. So it seems to me a very way to express the issues. The basic issue -- and I just want to repeat what he said -- for patients is, how can I get this thing that is effective, that is safe for me, whether it is through a licensed doctor, through an acupuncturist, whoever it is. Their concern is getting the services, and I think we really need to recognize that. It is fine to say safe and effective, but we need to recognize what everybody on this side of the room has said, which is that there is a real consumer issue here.

    DR. JONAS: Well, just to address the accountability issue, I have a paired recommendation that would then address that together. So we can talk about that when we are finished discussing this.

    DR. GORDON: Tieraona.

    DR. LOW DOG: I am getting ready to leave you all. So I had just a couple of things that I just want to say, for whatever they are worth. When you are talking about access, the ability for somebody to go could be limited by income, but that is true of many things. We have published studies that actually show watching comedic movies are very beneficial to health, but do we pay for people to go to the movies? We have evidence that Resveratrol and red wine is very beneficial for the cardiovascular system. I would love for the government to pay for my chianti, I really would, and would argue for its health benefits. However, I think it is more to me, when you are talking about access, of something just being safe and effective. There are a whole lot of other consideration that has to go into what we are paying for, and what we are not paying for.

    I would like to encourage again that we just keep in mind about evaluation and going back to demonstration projects to begin to explore team approaches, exploring ways to begin to determine who needs what and how it will benefit us, but to be thoughtful in that process. Just because something is safe and effective, it doesn't mean we pay for it. We deal with this with OTCs all the time. Many of these are safe and effective, but you pay for them out of your pocket.

    Page 23


    The last thing, is to keep in mind that I have some personal issues. I want to be very careful about what we are going to recommend is covered when many people don't have access to basic medicine, a prescription.

    As a Navajo gentleman told me recently, "Have you thought that maybe some of us may perceive that you are trying to give us second-class medicine, medicine that has not been proven, medicine that has not been shown to be effective, because you think it's cheaper, and that maybe that is the way you are going to deal with our health problems?" I think that we have to be sensitive to that perception. Thanks a lot.

    DR. GORDON: Before you go, and before we thank you, Tieraona, I would like to ask you if you have any thoughts about how to address that last issue that you just raised.

    DR. LOW DOG: I think part of it is through demonstration projects, evaluation and demonstration projects, which I do believe were in earlier iterations of this draft, which I think, then, address these issues in a way that doesn't let us believe that is what we are actually doing to underserved populations.

    DR. GORDON: Including the issue of people perhaps feeling they are getting second-class health care.

    DR. LOW DOG: Yes. Yes.

    DR. GORDON: So through demonstration projects.

    DR. LOW DOG: And evaluation.

    DR. GORDON: And evaluation.

    DR. LOW DOG: You have got to have the evaluation to determine what you are going to do a demonstration project on.

    DR. GORDON: Good. I just wanted to make sure we had your thoughts on it.

    DR. LOW DOG: Thank you and thank everybody for this process.

    DR. GORDON: Thank you.

    [Applause.]

    MS. SCOTT: I want to support what Ti just said, because the formation of recommendations of action items under this section, I would encourage us to look at what is already being explored for these populations of people in existing work, such as the Medical Practice Act, looking at the Surgeon General's Report. All of these deal with access, so I don't think we have to reinvent the wheel, but I think we need to have a couple of them that are applicable to access to safe and effective CAM services.

    Page 24


    DR. GORDON: Julia, does it make sense to you to come back to the recommendation that Wayne put forward, and for us to discuss that at this point? Or, are you looking for another recommendation on the section?

    MS. SCOTT: No, no, I'm not looking for another recommendation. I am supporting what he put forward. All I am suggesting is there are places we can go to look for action items, other than the ones that are listed here.

    DR. GORDON: I've got that. I hope we all have that understanding, that even if this recommendation comes forward, there are other concerns that you have. Joe.

    DR. FINS: We have sort of come full circle, because we are having conversations that we had on the very first day when we were going around the table and somebody was asking for each of our own world views. I was struck by what Tieraona just said, what that Navajo gentleman was concerned about, and what the gentleman who did the Spanish radio shows -- I think it was in Washington --

    DR. Huerta, I believe his name was.

    I think it is really important that our purview is really not to address access in general. That is not within our mandate. We appreciate that any recommendation that we are making is in the context of access for complementary and alternative medical services, practitioners, or whatever.

    We would say as a guiding principle, and I think we all can agree, that access to CAM is meant to complement, it is meant to augment, it is never meant to substitute for, conventional access to health care. I think that should be stated clearly, so that that Navajo gentleman, who was instructing us from 2,500 miles away, would be reassured, because I think separate is not equal.

    DR. GORDON: Joe, it is important that that be made clear and adumbrated in the text. Yes?

    DR. FINS: Yes.

    DR. GORDON: Are we in agreement about that point, that we are not talking about getting acupuncture instead of antibiotics if what you need is antibiotics?

    DR. WARREN: Separate is not equal, but separate doesn't imply superiority by one or the other.

    Page 25


    DR. FINS: I'm saying, look, people are free to choose what they want. If somebody is sick and they want to go for acupuncture instead of bypass, or they want to do the Ornish diet instead of acupuncture, one of our principles is they have the right to choose. What I am saying is, that as policy we should say that separate is not equal, this is not as a substitute for. The presumption is that all the people who are calling

    DR. Huerta's radio show wanted conventional health care and they were obliged, because of their poverty and their disenfranchisement, to seek this alternative sort of care because they could pay for it, it was accessible.

    DR. GORDON: I think, Joe, without quoting Huerta, your point is well taken. I think the point is basically we are not saying that people should not have access to conventional medicine and instead they should have access to CAM. We are saying that whatever access they may have to CAM, they also should have access to conventional medicine. This is not an either/or.

    DR. FINS: I just want, for the record, to say I don't mean to misquote

    DR. Huerta.

    DR. GORDON: I think we understand the principle here. I want to get head nods to make sure we have this general principle, that we are not saying throw out conventional medicine and give them CAM instead. We are saying that there are many systems. Yes. We've said it.

    DR. WARREN: We are saying free choice by the consumer as to which, as long as they have got equal access to both. They can take free choice, and it is their informed consent that implies that, correct?

    DR. FINS: Choice implies voluntariness, and if one is uninsured, they may not have as much free choice. The goal here is to never have them feel, based on any government policy, that we are giving them a second-tier intervention, because there may be situations where it is as good as or better than. I think I said what I meant to say, and I hope somebody was recording it or whatever. Just as a principle, the Navajo gentleman's concerns are ones we have to resonate with, but also, at the same time say that people are free to make their own choices. Some people are coerced into certain choices because of their poverty.

    DR. GORDON: I think there is general agreement on this principle. Do we have general agreement on this principle? Okay. Yes, Dean.

    Page 26


    DR. ORNISH: I agree with that principle, but a corollary of that principle is that, with access there needs to be information. One of the things that you said earlier which didn't account for that, was that this is only about access. I think a direct function of access is information about efficacy, the kind of things that Tieraona was talking about in terms of demonstration projects, and the kind of things that Wayne is talking about in terms of accountability. It is not only accountability in terms of accountability to standards of your own profession, but information that the consumer can use to make those kinds of decisions.

    DR. GORDON: I think that's a very good point. Now, I would like to get, if we can, a Recommendation No. 1, and then take a break and have public testimony, which we are scheduled to have, and then come back and move through the rest of the recommendations.

    DR. ORNISH: Since some people have to leave, like me, is it possible that the public testimony could be delayed for half an hour so we can continue this, and then continue it? I mean, there are several people that have to leave, but if not, then fine. I just want to put that out there.

    DR. GORDON: Let me ask, how many of the people are here who are going to be giving public testimony?

    [Show of hands.]

    DR. WARREN: I would like for all the commissioners to have a chance to listen to public testimony. We have walked out on them before, and I don't think we ought to do it again.

    DR. GORDON: In fairness to the people who have come here and set aside their time, I think we should have public testimony at the appointed time. We will pick up a half hour later. I would like to come back to Recommendation No. 1, if we could. Wayne, do you want to state it how you have fashioned it?

    DR. JONAS: I think if the first one is accepted to deal directly with the access issue and not the licensing issue, then I think, as we discussed, barriers in access are the appropriate focus, again, focus on safe and effective, identifying those things that are safe and effective. The second recommendation, then, I think, can address the licensing issue, and the primary focus there is accountability. Now, the problem we have discussed with that is, that is not in the federal purview, unlike what could be done initially on the first recommendation. So here, I think the federal government's role could be in facilitating the states in developing their own guidelines. So I would like to propose some wording to help that so that it does give a role for the federal government, but it is not a role in which it is dictating any kind of guidelines to them.

    Page 27


    Again, this can be reworded. What I have done, actually, is, I have taken Action Item No. 2 and reworded this as a potential thing to address this, because I think this got at least as close as possible. To say something like, "The federal government should assist states," and one could say "by" or "in" "developing guidelines for" -- and I scribbled around in this. I've got to make sure I get this right -- "for establishing accountability and competence in CAM delivery, including," and then list: standards of practice; scope of practice; education and training; registration, licensure or exemption; and professional oversight. So in other words, list some of the items that are involved in what those accountability items are, which are already in that paragraph, but we just pushed them down towards the bottom.

    DR. GORDON: So, would that be Recommendation No. 2?

    DR. JONAS: I think that would be Recommendation No. 2.

    DR. GORDON: Then come back to Recommendation No. 1, if you would, and then read Recommendation No. 2 again, so we have them both together.

    DR. JONAS: All right. I should have written out in more detail. Recommendation No. 1 is actually on the board in the back. It is, "The federal government should evaluate current barriers to consumer access to safe and effective CAM practices and qualified practitioners, and develop guidelines to remove those barriers and increase access." So that addresses the direct access issue. Recommendation No. 2 is, "The federal government should assist states by developing," or "in developing guidelines for assuring accountability and competence in CAM delivery, including standards of practice; scope of practice; education and training; registration, licensure or exemption; and professional oversight."

    DR. GORDON: Can we discuss these two recommendations? Thank you, Wayne, very much for the reworking. Joe, do you want to comment on these? Wayne, do you want to read them again?

    Let's read them once more, and if we can discuss them in the next little period of time, great. If not, we will put off the discussion. I would like everybody, though, if people are leaving, to have a chance to address both of them before they go. So read them again, Wayne, please.

    DR. JONAS: No. 1 is about access, and it is that, "The federal government should evaluate current barriers to consumer access for safe and effective CAM practices and qualified practitioners, and develop guidelines to remove those barriers and increase access." That is No. 1. The second one is that, "The federal government should assist states in" or "by" -- I'm not sure -- "developing guidelines of accountability and competence in CAM delivery, including standards of practice; scope of practice; education and training; registration, licensure or exemption; and professional oversight."

    Page 28


    DR. GORDON: Thank you very much. Comments on either No. 1 or 2? Dean and Charlotte first, and then Joe.

    DR. ORNISH: I liked Wayne's recommendations. I just wonder, is there any way within Recommendation No. 1 to put anything about accountability or safety, efficacy, anything beyond just -- pardon me?

    DR. GORDON: Safety and efficacy, I believe, is in there.

    DR. FINS: But I think accountability is a practitioner.

    DR. ORNISH: I missed the safety and efficacy part. Is that part of No. 1?

    DR. JONAS: That is No. 1, actually. That's why I suggested we look at the barriers.

    DR. ORNISH: Fine. I like them. I think they are really good.

    DR. GORDON: Joe just pointed out that accountability is more a practitioners issue than a practice issue.

    DR. ORNISH: I like it.

    DR. GORDON: Other comments about these two? Charlotte.

    SISTER KERR: Wayne, you've done No. 2 and you remembered my concern. I'm not sure if I have copied right: "The federal government should assist states in developing guidelines" -- I need your feedback -- "for establishing accountability and competence in CAM." I mean, it doesn't even say in this case that you are going to collaborate with anybody. Again, I don't have it exactly in front of me. "The federal government is going to assist the states to develop guidelines in these areas."

    DR. JONAS: Well, this is why I said "in" or "by." One could say, assist the states in developing accountability and competence "by" developing guidelines, in which case then the federal government would simply do it. They would say, here are guidelines that we think are appropriate for accountability. These are some things that states can now take and individualize to their particular requirements.

    DR. FINS: Developing and assessing guidelines. In other words -- I'm looking to Don -- because it is the issue of assessing, because there is a heterogeneity, a possibility, developing and assessing. I liked Max's idea, the states are the laboratory of democracy; let's assess it a little bit. That is not exactly what he said, but it's the spirit of what he said.

    Page 29


    DR. HEIRICH: That's a nice sentence.

    DR. FINS: It wasn't mine, it was Jefferson. But assessing.

    SISTER KERR: I think this is real important. I am still not clear -- and I want to see it in front of me -- is the federal government going to offer guidelines to different disciplines as to how they should regulate themselves? If we are saying that, I am not for it.

    DR. GORDON: I am going to suggest that this is going to require more discussion. What I would like to do is take a five-minute break, and then come back for public testimony, and then we will pick up and go into these issues after public testimony. A five-minute break. Could we call the first panel to come forward? We will have public testimony, and then we will come back to this discussion.

    [Break.]




    Public Comment Session

    Joyce Frye, DO, MBA, National Center for Homeopathy

    DR. FRYE: My name is Joyce Frye of the National Center for Homeopathy. A year or so ago, Joe Fins made the astute observation that CAM is a symptom of the diseased health care system. The homeopathic treatment of that disease, according to the law of similars, would be to stimulate CAM until the organism brings itself back into balance. Clearly, that is what the Commission is attempting to do in its recommendations, and with the establishment of CAM Central for implementation. So we congratulate you on your homeopathic perspective in creating this remedy.

    There is considerable overlap between your recommendations and those from the NCH, which you have at place. So, to the extent that they can be carried forward into specific CAM Central activities relative to homeopathy, we will be very happy.

    Speaking for myself, I have one very deep concern. That is, while your remedy is correct, the potency may not be. Specifically, the word "should" is universal in your recommendations. There are no carrots and no sticks, and "shoulds" only go so far in changing behavior. We should exercise and eat right. One hundred years after the Civil War, Rosa Parks should have been able to sit anywhere on the bus, but it took years of mandated integration and affirmative action to gain something approaching equal opportunity.

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    In the last several months, we have provided testimony to the House Committee on Governmental Reform, and to NIAD, and to NCCAM, and to Secretary Thompson about the potential benefits of investigative homeopathic history in treating bioterrorism, and we were politely dismissed. CDC and NIAD should have been beating down our door, trying to figure out how they could use this and investigate it.

    For CAM to move forward, conventional medicine is going to have to share its seat on the bus, and sometimes even sit in the back. It will not do that without a fight. So at the very minimum, your Recommendation No. 1.1 for CAM Central has to include the word "authority" along with "budget" and "staff" in order to carry out these recommendations.

    I would like to suggest that you take an even bigger step and recommend to Congress that they enact legislation mandating affirmative action in the study and implementation of CAM procedures and protocols for a defined period of time until this health care system can come back into balance.

    DR. GORDON: Thank you. Let's wait until all the speakers have spoken, then we can ask questions. Madan Khare. Is that the proper pronunciation?




    DR. KHARE: Good enough.

    DR. GORDON: Okay, thank you. Madan Khare, DVM, MS, PhD, American Complementary and Alternative Veterinary Medicine Association

    DR. KHARE: On behalf of the Complementary and Alternative Veterinary Medical community, I thank you for giving me the opportunity to speak with you today. My name is

    DR. Khare, and I am a microbiologist and a practicing veterinarian. I do not need to emphasize the bond between humans and their family pets. Even the President of the United States, when stepping off the helicopter on the White House lawn, he picks up his dogs, Barney and Spot, instead of his wife and kids. The family pet has proven to be therapeutic and valuable to cancer, psychiatric, and nursing home patient management. More and more, pet owners are demanding CAM health care for their other family members, their pets. Academia and associations are making concentrated efforts to ensure continuous training and education of CAVM practitioners. We need validation and acceptance of their efforts. Recognition of this vital process by this commission will tremendously ensure that the consumer receives high quality CAVM care for their pets.

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    The CAVM academic and individual research communities are engaged in shared research. Through research and quality control, the CAVM industry is engaged in production of quality products. However, we need more support and cooperation from local, state, and federal providers. Recognition of this need by this commission will help increase our resources. CAVM practitioners are active in promoting consumer awareness. However, again, we do need your help in our quest to educate pet owners about CAVM.

    CAVM practitioners are providing efficient and effective modalities to their patients. However -- I am repeating like a broken record -- we do need resources to standardize the implementation of standards. On behalf of the CAVM community, I request that this commission recognize the role and place of CAVM in pet health care. I urge this commission to mention and include in your report the need of a certain level of policy and procedures regarding CAM for the family pet.

    Finally, I thank every member of this commission for giving me the opportunity to express my views.

    DR. GORDON: Thank you very much, and thank you for presenting a viewpoint we have not heard before. So I really appreciate it.

    DR. KHARE: Thank you, sir.

    DR. GORDON: Boyd Landry.




    MR. LANDRY: I follow

    MR. Kriegel.

    DR. GORDON: I don't think

    MR. Kriegel is here. Boyd J. Landry, MPA, The Coalition for Natural Health

    MR. LANDRY: Well,

    MR. Chairman and members of the Commission, my name is Boyd Landry, as you all know, and I am executive director of the Coalition for Natural Health. At the close of today, this part of your journey will be over, and what remains is how your work will be received, reviewed, and acted upon. Further, as commissioners, you should be wary of being labeled as a self-serving body. I say that because at the last two meetings, this issue was brought forth at the beginning of the meeting for you to look at and realize and be cognizant of.

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    Since I do not have a copy of the text of the report, I can only speak to recommendations and action items. Initially, I want to address the usage of the terms "safe and effective." This phrase is used over and over throughout the report, and it creates an interesting dichotomy because consumers have a right and expect all products to be safe. Effectiveness is a relative term, defined by science to some extent, and by consumers of the products themselves.

    You may not realize it, but you only recommend that CAM products be safe. There is no mention of effectiveness. Practices have to be safe and effective, but products need only be safe. Where is the consistency? Where is the difference? Let consumers decide effectiveness, and the let the government attempt to guarantee safety.

    On the issue of elevating CAM providers to primary care physician status, we agree with

    DR. Fins, there are vast differences in the education and training of conventional medical providers and CAM providers. If CAM providers want to be viewed as primary care, they must receive the same level of education and training that conventional medical providers receive, which includes comprehensive residencies and internships.

    By continuing the proverbial carrot of loan forgiveness and tuition reductions by way of scholarships, to recruit providers to underserved areas, is a faulty premise. In a recent AM News article, in the American Medical News, it stated that statistics show that providers are born and raised in underserved areas more so than they are recruited to them. All you have to do is look back to the CBS series "Northern Exposure" for a comical example of that.

    Access and delivery is a major issue for the Coalition. I want to use the majority of time of my last public opportunity to address this issue. I cannot hammer enough the fact that this commission, in its recommendations and action items, has ignored and disrespected the most comprehensive piece of state legislation in this area in the last five years, and that is the Minnesota Health Freedom law.

    The Minnesota law has now formed the basis of legislation that has been introduced in Rhode Island, New York, and California. Rhode Island and California have an excellent chance of passing their versions of the legislation in their respective legislatures this year. The Minnesota law created access to CAM providers for the entire public, and provided public accountability and public redress.

    The Rhode Island State legislature recognized that CAM is a growing industry, and it also recognized that the state cannot afford to license, certify, or register every modality, therapy, or their derivatives. By grouping these practices, modalities, and therapies into one group that is accountable to the public, without overburdening the state and the practitioners with unnecessary regulation, guarantees the widest net of access.

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    MS. AXELROD:

    MR. Landry, your time is up.

    MR. LANDRY: I'm sorry. I have two short paragraphs. With respect to coverage and reimbursement, I caution you against falling into the trap that coverage and reimbursement is the key to greater access. It is our fundamental opinion that issues involving access and delivery must be worked out long before discussions should take place regarding coverage and reimbursement. There is a plethora of issues surrounding coverage and reimbursement.

    Finally, I want to thank you for the multiple opportunities to address the Commission. It is my hope that the many points that I have made, and the points made by the constituency I serve, make their way into the report and the recommendations.

    At this time, the recommendations do not reflect the needs of a large percentage of the CAM community. I cannot comment about the text of the report because I was not given a copy, which you have but we don't. Thank you for your time and attention, and good luck in these final weeks in preparing your Final Report.

    DR. GORDON: Thank you very much. Hiroshi Nakazawa. Hiroshi Nakazawa, MD, American Board of Medical Acupuncture




    DR. NAKAZAWA:

    MR. Chairman and the Commissioners, good afternoon. My name is Hiroshi Nakazawa. I am chairman of the American Board of Medical Acupuncture, ABMA. I was educated in Japan and the United States, and completed my residency in surgery at the St. Agnes Hospital in Baltimore, where I am senior attending physician in the Department of Surgery and Anesthesiology. I have practiced medicine since 1962, and medical acupuncture since 1995. I am a past president of the Baltimore City Medical Society, past executive committee member of the Maryland State Medical Society, and have spoken around the world on the topic of medical acupuncture, which is a combination of ancient Chinese medicine and Western medicine, as practiced by the Western-trained physician.

    I have presented my credentials to underscore the respect I have for education and competence in health care training. Today, I would like to focus on one credential in particular, my certification by the American Board of Acupuncture, the ABMA, because it represents a milestone in the level of expertise which medical acupuncture has achieved in areas of training, education, certification, and accountability.

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    The ABMA was created in April 2000 as a separate entity within the American Academy of Medical Acupuncture, AAMA. It has an independent board of trustees responsible for the direction and operation. The mission of the ABMA is to promote safe, ethical, and effective medical acupuncture to the public by maintaining high standards for the examination and the certification of physicians as medical specialists. As in other medical specialties such as radiology or pediatrics, the ABMA establishes requirements for qualified applicants, conducts the exam, and issues certification to those who successfully complete these criteria. The certification process is intended to provide the public with physicians who have completed an ABMA-approved education program and passed the board examination in medical acupuncture covering a multiplicity of acupuncture paradigms.

    To date, nearly 200 of the Academy's members are certified, up from 83 just six months ago. Enthusiasm for the program is clear.

    Candidates for board certification must have graduated from an accredited allopathic or osteopathic medical school in the U.S. or Canada, or possess a certificate of ECFMG, namely the Educational Council for the Medical Graduate. They also must have a valid medical license and good ethical standing in the community. Applicants must complete a minimum of 300 hours of acupuncture training acceptable to the ABMA, at least 200 of them in a formal course program which meets WFAS standards and includes instruction in auricular, energetics, TCM, neuro-anatomic, and other acupuncture disciplines. Further, at least 100 of these hours must be in an approved clinical setting. Eight schools have been, so far, approved. Those candidates who meet the above eligibility and educational requirements may sit for the certification exam.

    In addition, applicants must certify that they have two years of medical acupuncture experience subsequent to the basic 200 hours training, and a case history of no fewer than 500 medical acupuncture treatments. They must also provide three physician references as to their character, professionalism, and adherence to standard clinical practice.

    In effect, the ABMA has designed a program that brings medical acupuncture into the spectrum of the Western medicine specialties, and by so doing, will raise the awareness and the reputation that complementary medicine in the minds of the American public.

    The requirements and oversight of the certification program will continue to raise the bar for all practitioners of acupuncture. We ask your support in recognizing that medical acupuncture is a practice and approach unto itself whose standards are in keeping with the most advanced health care system in the world, and whose guardians are committed to its success.

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    Thank you very much.

    DR. GORDON: Thank you all very much. Questions from commissioners? Charlotte, you had one earlier?

    SISTER KERR: How much time do we have for questions? All right, I have three questions. Now, this is

    DR. Frye, correct? What was the outcome on the offering to assist in the bioterrorism? Basically, they kept referring you back to NCCAM to get money?

    DR. FRYE: You have the two letters at place, I think, that we received back.

    SISTER KERR: I have, yes.

    DR. FRYE: Basically, they gave us pat information about what was going on, and said thank you very much, we can do this.

    SISTER KERR: And you feel you have something more to offer in that area, specifically?

    DR. FRYE: We think we have a great deal.

    SISTER KERR: You are, at this point, at a dead end, right?

    DR. FRYE: Right.

    SISTER KERR: Thank you. Boyd, thank you for being loyal to your people and all of us. I was concerned, at the end of your report you said that you couldn't review because it is not given to you. I thought everything was on the computer.

    MR. LANDRY: No, that's not true. We are only given the recommendations and the action items.

    SISTER KERR: So you are given the recommendations.

    MR. LANDRY: Right, because what appears to be the case, is the text is somewhat different. Although it is supposed to be in conjunction with the recommendations and action items, we are not able to review that information until its final form.

    SISTER KERR: Thank you.

    DR. Nakazawa, thank you very much for your presentation. I am around the corner from you in Columbia. May I have some clarification? This new board that was formed, it is a separate entity. So you are not in any formal relationship with the American Academy of Medical Acupuncture? If that is so, I am interested in the board certification. Would you be separate or considered to have much higher requirements than being just a member of the American Medical Acupuncture?

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    DR. NAKAZAWA: About two years ago, the ABMA group has been actually established within, as I mentioned, AAMA. So that, at this moment, we are at the beginning stage, we are not completely separated yet. We have, now, at least a separate entity, at least nothing to -- what do you call it -- interfere by the AAMA. However, financially, we are not anything. We just started off. We are still in the embryo stage, I should say, for that matter.

    DR. GORDON: Other questions? Effie.

    DR. CHOW: Thank you all for your input.

    DR. Nakazawa, can you explain why was the ABMA established within the AAMA? What is the purpose of having the two?

    DR. NAKAZAWA: This has been, as you know, 1987 when AAMA was established. The physicians of the group, I understand, they all some day would like to have one separate board for a medical specialty like a board certified surgery and so forth. At that same time, we should have to elevate our standards to certify the physician, certify the acupuncturist. So in a way, they tried to establish a little higher, let's say, level, because if you just become a graduate from a bona fide acupuncture school -- as you know, we have so many in the United States -- as long as you apply to AAMA, you can be a member, but it is not necessary that everybody has upgraded education and that they have to take so many courses and so forth. And so, they decided to have some, perhaps, higher standards which needed some kind of certification. As you know, AAMA has the same thing. Someone can be an internist, graduate from a bona fide training school, but he or she may not be board certified. To have board certification, he or she has to go take an examination, which can be quite difficult. They have to go through so many hours of training, et cetera. So this kind of, a little bit, distinguishes the physician, so to speak.

    DR. CHOW: I guess I am not quite clear. I guess the AAMA and the ABMA, you have the same number of hours of training, and then the ABMA requires continued education, and AAMA does not require continued education? How do you get that extra status?

    DR. NAKAZAWA: Well, we have bylaws which are set by the so-called membership in AAMA, but the highest is a fellow, and the next to the regular members and so forth, we have to have at a minimum, to qualify, 75 hours education in three years to be in a fellowship. ABMA, however, you have to not only finish school, college, you have take an examination, a board certification examination. Once you pass that examination, he or she has to prove that this person has two years in addition to that, has a minimum of medical training in acupuncture, and also, as I said, no fewer than 500 medical treatments. This has to be proven with an affidavit.

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    DR. GORDON: Thank you. Wayne, or Charlotte, or both of you.

    SISTER KERR: Just one quick question.

    DR. Nakazawa, one of the things that I value, both in this work and in my own professional work, is collaboration and partnership. My own experience has been -- and I have such respect, in my own background in teaching nursing, for the medical community -- that we would partner and collaborate in our continuing education. I have often seen many good workshops from the doctors. I am wondering if you have ever considered any leadership in working to bring us all together, the non-physician acupuncturist and the doctors, because the bottom line is we work together; there is so much we share. It seems like we are still having trouble coming together. Would you comment on that?

    DR. NAKAZAWA: I appreciate very much your concern, and I am so glad to inform you that we now, at the AAMA and the ABMA, we have, as you know, an annual symposium. We have about 400 to 500 physicians get together every year. This year, we are open to everybody. So anyone who wants to come -- you mentioned something, licensed practitioners -- anyone who would like to come in, that's fine. As a matter of fact, we are going to have a speaker. It's not necessary to be a physician.

    SISTER KERR: I really commend you on that, and I cannot thank you enough for that offering to the community. Thank you.

    DR. GORDON: Any other questions or comments? Wayne, please.

    DR. JONAS: I want to thank the panel and I want to thank, Jim, for making sure that we did this, and I think some others who suggested that we do this, because we saw this huge list of public testimony over the past two years. Somehow, as we get involved in the discussions, it seems to rapidly fade. I am speaking for myself here, it seems to rapidly fade. So doing this on a regular basis just flips off those neurons again and reminds me that this is in fact a massive effort of individuals calling out and saying, we want something different in health care and we are doing something different in health care; pay attention. I would like to ask

    DR. Frye if she would elaborate a bit on her organizational analogy around homeopathy. If complementary medicine is the disease and we are trying to select a remedy for this, would you suggest that a constitutional approach would be more effective, in which we pick a single remedy infrequently given and focus on a very particular core issue, the essence, if you will: time; compassion; healing interactions; and healing function?

    Page 38


    Or, should we take a more clinical diagnostic, mixed approach in which we make sure we have covered all of the symptoms, a head remedy for CAM Central, an ear remedy for the information, a feet remedy for payment, and give it more frequency at a lower potency?

    And the second question, what is the potency? My understanding is that if you more precisely select the remedy, you can often get a very high potency at a very minimum dose, in which case, are we giving too much too often?

    DR. FRYE: Can you do that again, one at a time?

    DR. JONAS: Yes. What is the approach? Is it constitutional, where we need to prioritize all these massive recommendations we are making in saying, this is the one we need to do now? Or, is a more mixed approach, in which we need to cover all bases and give more?

    DR. FRYE: Well, I think it is an approach that looks at all of the symptoms and understands that all of those ultimately need to be healed, but there are some priorities about in what order that will happen. I certainly can't tell you what priority that should be. I haven't been sitting here for two years giving thought to that, but I am sure that that could be done. Some of it, again, addressing the issue of mandating this kind of thing is allowing each part of the organism, each structure to figure out for itself what it means to heal, and just simply giving it the mandate that this is what has to be done, and figure out how to do it.

    A similar example might be in the City of Philadelphia, where I am from, there is a mandate that when you erect a new structure of any significant size, it has to have an art component to it. Nobody tells them what that art has to look like. It might be a particular garden or a particular fence, or a particular sculpture, but as long as it is something that is generally considered to be art, they can figure out for themselves how to prioritize that.

    So I think if you tell NIH that a certain percentage of its budget has to go to CAM, you can let them figure out how they want to do that, but that the mandate has to be there across the board.

    DR. JONAS: So it sounds like a constitutional approach to me, then.

    DR. FRYE: I think so.

    DR. JONAS: Okay.

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    DR. GORDON: Thank you all very much. I especially want to thank Boyd Landry for his coming again and again, and presenting his point of view to us.

    [Applause.]

    DR. GORDON: We have one more panel, Riva Touger-Decker and Cassandra Wimbs. Riva, would you like to begin, please. Riva Touger-Decker, PhD, University of Medicine and Dentistry of New Jersey




    DR. TOUGER-DECKER: Good afternoon. I Riva Touger-Decker, and I come as acting director of the Center for the Study of Alternative and Complementary Medicine at the University of Medicine and Dentistry of New Jersey. I don't think anyone can say that 10 times fast. The need for allied health, medical, nursing, and dental education programs to prepare students with the knowledge and skills they need for good patient care is driven, in part, by increases in CAM use by consumers.

    These health providers must be able to understand the spectrum of practices known as CAM, efficiently question their patients, understand and evaluate their individual reasons for use of CAM, be familiar with the potential harm of these therapies, whether they are used independently or in combination with conventional medicine, and the potential benefits, and advise consumers accordingly about the use of such therapies to provide the best possible care.

    They must be able to understand and adapt to changes in health practices, collaborate across disciplines, and develop referral systems among those disciplines. Education of traditionally trained health professionals just has not kept pace with consumer usage patterns of CAM. All health professionals need to be able to provide consumer with scientifically sound, credible guidance about CAM. Although several allied health and medical associations have formed special interest groups, their efforts continue to remain inadequate to meet the needs of students in these disciplines.

    The Society of Teachers of Family Medicine has published guidelines for CAM education of medical students. No such guidelines exist for teaching students in allied health or dentistry. Although U.S. medical schools have formed a consortium of academic health centers for integrative medicine, there is no organized effort to integrate CAM in allied health and dental schools. This past July, our dean, DR. David Gibson, the dean of UMDNJ - School of Health Related Professions, conducted an Email survey I designed to look at allied health profession schools in the U.S. who are members of the Association of Schools of Allied Health Professions. Less than one-third of the schools responding had elective courses, and none of them had required courses on CAM.

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    It is imperative that all health professionals have a detailed understanding of scientifically sound CAM practices. Such professionals must be able to apply rigorous scientific standards when examining CAM modalities to promote comprehensive care, reduce risk of interactions and potential harm, and enhance benefits. The ability to differentiate between practices supported by sound research and those that have no scientific basis is important for public safety.

    The establishment of core competencies and curriculum guidelines for CAM education is critical for integrative and safe patient care. Such guidelines should be available for adoption by educational programs for allied health professional, and all health professionals with direct patient care responsibilities.

    The collaboration of key professional associations in developing these guidelines in competencies would be invaluable to help to establish and broadcast them to their constituents.

    DR. GORDON: Thank you very much.

    Questions from the Commissioners?

    [No response.]

    DR. GORDON: I just want to raise a question, which I don't know if you were for earlier discussion, when Tom Chappell was asking about schools of dentistry, and we have a discussion with some staff input. What do you think the issue is with schools of dentistry? Why is there what seems like a lack of interest in these approaches?

    DR. TOUGER-DECKER: I don't know that it is a lack of interest. As a nutritionist by discipline, with a doctorate in nutrition and oral health -- I work in a school of dentistry, as well as with our allied health school -- I think, in part, part of what has affected medical education is they don't see the direct link. In many ways, dental education, like some others, is almost bulimic in its approach, in that there is so much to absorb, and how much do they have to spit back. It is just a practical example. I sit in the American Association of Dental Research in their Nutrition Section. As a research group, we are trying to approach it. The ADEA, The American Dental Education Association, hasn't embraced it as a competency priority.

    One of our goals at UMDNJ -- and I was here earlier, and pleased that we broadened it to all health professions -- is that we are center that represents our three medical schools: nursing; allied health; dental; and biomedical science schools, but we are housed in an allied health school.

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    Our goal is to come up, unless others come up sooner, with curriculum guidelines and competencies, because there is an interest in some dental schools. Our feeling is if we do take the beginning approach, others will start to adopt and collaborate.

    So I don't think it is a lack of interest, I don't think it has become a priority on their radar screen.

    DR. GORDON: Thank you. Don.

    DR. WARREN: On the dental school front, there is so much information to be taken in just to pass the boards. If we put in a CAM course, I get the indication from Tennessee, possibly, that that might affect their accreditation for the school, because the American Dental Association doesn't really approve of any CAM. Is that a potential possibility?

    DR. TOUGER-DECKER: I don't know that ADA, ADEA, doesn't approve of any CAM, it is not a competency. I am not sure that they need a specific course. In other words, it may need to be that those competencies in CAM are integrated throughout the curriculum in courses like clinical medicine, like preventive care, that it is not a course, that it becomes part of the other competencies that have. That may be a more effective approach, rather than to keep starting new courses.

    DR. WARREN: But to do something like that, you have to have the faculty educated in CAM before you ever start that integration into the courses.

    DR. TOUGER-DECKER: Exactly. It has to be something that the academic deans embrace, and then get their faculty to embrace it. We have taken the approach of trying to embrace faculty, because if we don't, students won't get to implement it or learn it. I agree with you.

    DR. GORDON: Any other questions?

    [No response.]

    DR. GORDON: Thank you very much. I would be curious, Riva, as this develops, if you would at least keep me informed about what is happening with dental schools and allied health professions.

    DR. TOUGER-DECKER: I will. I will be out at their meeting in two weeks, so we will let you know.

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    DR. GORDON: Great. Thank you. Public testimony, the time has concluded, and we are going to return to our deliberations on Access and Delivery. Do you need a two-minute break? Let's have a five-minute break -- do you want 10 minutes? Does everybody want 10 minutes here? Okay, let's take 10 minutes, and then let's come prepared to move through Access and Delivery to the end.

    [Break.]

    DR. GORDON: Let me remind everyone that what we are going to be doing is we are going to moving through Access and Delivery, then we are going to go to Reimbursement, and at the end we are just going to remind everyone who is still standing, or sitting, what the procedures are going to be for the next couple of weeks.

    MR. DeVRIES: In terms of a time check, Chair, what is the time frame, given it is 4:00 now, to get these things completed?

    DR. GORDON: My hope is that within the next hour to hour and 15 minutes, we will be able to finish Access and Delivery. I think Reimbursement is in pretty good shape, is my estimate, and I am hoping we can do that all together in 45 minutes to an hour. So I am hoping we will finish shortly after 6:00, or by 6:00.

    MR. DeVRIES: I need to leave at 6:15. Obviously, if you all want to continue until 9:00 or 10:00 tonight.

    DR. GORDON: You're not staying for the pajama party? My hope is that by 6:15, we will all have completed our work and will happily go home. Charlotte, you raised a question at the end of the discussion that I wanted to come back to. We are currently discussing Recommendation Nos. 1 and 2, and then we are going to move into action items, discussion both of the ones that are present, and also of other ones that commissioners feel are needed.

    We were in the process of discussing the recommendations, and Charlotte had a concern, which I would like to come back to. The recommendations are behind me, Recommendation No. 1, and then for Recommendation No. 2 there are two options for some of the wording that Wayne worked with with Don, I believe. Right?

    So everyone cam look at those to refresh their memories. Can you read them? No? Let me read. Recommendation No. 1: "Federal government should evaluate current barriers to consumer access to safe and effective CAM practices and qualified practitioners, and develop guidelines to remove those barriers and increase access." Then, the notation here is that Action Item Nos. 6, 7, and 8 would change tone, and perhaps additional ones would go under that.

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    Recommendation No. 2: "The federal government should assist states and professional organizations in developing guidelines for practitioner accountability and confidence in CAM delivery, including either standards of practice, scope of practice, education and training, registration, licensure or exemption," which is spelling out the different categories that were present in the action item, "or just regulate the practice," and end there.

    DR. JONAS: There is one item missing, which is professional oversight, which is peer review from the organizations itself. That would have to be in there in any case.

    DR. WARREN: Is that where we were talking about assessments?

    DR. JONAS: Professional oversight.

    DR. GORDON: Where would that go?

    DR. JONAS: It would go in one or the other. My feeling is that that should be in it, regardless of whether we use A or B. "B" was the suggestion to summarize all of A to make it less cumbersome. "A" spells out more specifically some of the items, but in any case, professional oversight should be on there because that is what the professions would be responsible for, and the guidelines should include that. That is different than, simply, regulation. The professional organizations provide that, not the states.

    DR. GORDON: Charlotte, let's come back to your issue, and then we can move ahead.

    SISTER KERR: I want Boyd to listen to this, too. He is not a commissioner, but a brother. Anyway, my concern that I need to talk out is, I tried to image this, and I'm trying to think if I were president of the Maryland Acupuncture Society, for example, and I got a phone call, and we have worked on this for years, and the government wanted to help us develop new guidelines for our practice accountability, I suppose, depending on who I was, I would either say, "Well, that's good and creative," or, depending on how they were going to proceed, maybe I would say, "Well, how come they're coming in now and it's all this work." Now, it could be that the intention of this is that the federal government says, "Look, every discipline has disparity and diversity. We would like to hold a convocation where you bring all your folks together, and we would like to help facilitate a partnership of us, you, and state representatives, if we are all on track, are we serving the people the best we can, and let's talk about it."

    Page 44


    I really need some feedback here, because my sense is, when I read this -- particularly when I read that article that somebody brought on yoga and I was realizing how people are perceiving, maybe, things we are doing -- that I thought, "Gee whiz, everybody is getting scared that we are going to tell the yoga people what to do." I thought, "Oh my gosh." I have felt, actually, pretty comfortable thinking we are not doing any of these things.

    So this sounds a little bit more back to what I have tried to express. This is probably important to me, to feel comfortable about it before we leave.

    DR. GORDON: So, what are asking for?

    SISTER KERR: The concern is, are we saying the federal government is going to call everybody in and say, "Well, how are you all doing," and "What did you all do," write it down, tell us," or are we going to say, "Let's get together and talk about, are we up to speed, can we be of service to you." I mean, say there is a state that has no law. For example, I can't practice in -- or, maybe we just changed the law, but I think South Carolina, even, which is my home state, you can be a dentist, you can work under a doctor. My point is that that state, for example, might benefit from some national regulations, and we are trying to get it together in acupuncture. Maybe the federal government is the person to convene this, I don't know.

    DR. GORDON: Charlotte, you are asking for feedback from other commissioners? Okay. Joe and Joe, to begin, and Linnea.

    DR. PIZZORNO: Well, I think this conversation has been really quite good because it has helped me to understand the multiplicity of factors that seem to be getting a little confused here. It seems like there are three things here. One is the recommendation of licensure, certification or exemption as appropriate to promote public safety and differentiate amongst practitioner types. The second is, the government providing assistance to the states, and to try to figure out how to do it, because this is a huge challenge for the states.

    The third part, which is something that has come up that's new, that Wayne brought up, which I thought was really good was, some kind of evaluative process. Because we do have licensing right now, we do have certification, and we now have this experiment in Minnesota, it would be nice if the federal government could provide some kind of evaluative process as this goes on. So five years from now, we take a look and say, well, what actually happened.

    Page 45


    In at least the limited numbers of states where naturopathic doctors are licensed, we look at malpractice data, and we look at court decisions, and things like that, that the safety is actually pretty good, but that is something that has got to be studied for everything that is going on to see what the situation is.

    So I think, by looking at what Wayne has here, that looks to me more like an action item, because it doesn't embrace all these ideas. So I would like to have one idea which says what we want to accomplish, and then a series of action items.

    DR. GORDON: Joe Fins.

    DR. FINS: I want to respond to Charlotte, and then also to Joe. I think using a phrase like "offer assistance," was never ever meant that we could impose guidelines upon the professional societies. The acupuncturists and the TCM folks didn't agree to get along at public meetings here, they couldn't get it together.

    I think this is one of the functions that the central office might be able to facilitate. So I think offering assistance versus requiring compliance with a federally mandate. So offering assistance.

    The other thing is, I would add I totally agree with Joe said, that when there is a change in the law or a new guideline, there should be an evaluative piece. The professions, HRSA, AHRQ, are all the kinds of agencies that could help with that evaluative process.

    Then the other thing is that the federal central office can help disseminate and share information between states, although there was something in our earlier draft. There is an entity -- I forget the name of it -- where state legislatures communicate with each other. I think that is something that needs to be re-excavated from the December draft as well, as a clearinghouse function.

    DR. GORDON: Joe, how do you respond to Joe P's thoughts about, these should be action items rather than recommendations?

    DR. FINS: I think they are action items. I mean, I think the recommendation is that we should offer assistance, and these specific things could be delineated as action items.

    DR. GORDON: Linnea? No? Anyone else?

    [No response.]

    DR. GORDON: We have two recommendations here. Wayne?

    Page 46


    DR. JONAS: I just liked the idea that Joe suggested about evaluation. If we do anything with that, I would suggest it should be a third thing.

    DR. GORDON: A third recommendation, or an action item?

    DR. JONAS: A third recommendation, yes, because that is a role the federal government could supply, is evaluating what these various types of models of access and integration are.

    DR. GORDON: I think that is a great idea. I would like to get some decision on these two recommendations that are here. So let's talk about Recommendation No. 1. Are we in agreement with Recommendation No. 1? Yes? Can we have heads, hands, hearts?

    [Show of hands.]

    DR. GORDON: Recommendation No. 2, are we in agreement? Are we with this one? Yes? Okay.

    SISTER KERR: No. No.

    DR. GORDON: No. Charlotte, okay. Charlotte is not on for No. 2.

    SISTER KERR: I feel unheard, except for what Joe said, to say that we would offer to assist states and professional organizations.

    DR. GORDON: What would you like to have happen?

    SISTER KERR: Well, I want you all to respond to my concern, do you think anybody might feel like this? I am delighted to think there would be a federal office that would say -- I said it a few minutes ago -- "We would like to offer to help you all organize."

    DR. GORDON: So you would like to hear if other people share your concerns.

    SISTER KERR: Or tell me why I should not be concerned.

    DR. GORDON: Effie.

    DR. CHOW: You know, we have had this discussion many times. Also, many people have testified that they don't want the government coming in and telling them what to do. Joe said it is "offer," but I think we need to be very clear about that, and perhaps No. 2 isn't quite clear about that. I thought that was the decision of the group, too, before, that we would not regulate but we would assist associations, relevant associations and organizations, to help them make their own decisions.

    Page 47


    DR. GORDON: How about "offer assistance to interested state," et cetera, et cetera, as a way of modifying that?

    DR. CHOW: It is still state regulated. If you are offering to states, it has to be the state with the associations, the relevant associations, that are making the decisions.

    DR. FINS: Can I just clarify? There are two things that are conflated here. There are the professional bodies, which is one kind of assistance, and then there are states that are writing laws and regulations. So we might want to write two proposals or recommendations that look identical to each other, and distinguish a state one, and then a professional society one, because it is a little different.

    DR. CHOW: I think a simple way is to have consultants with the relevant profession, because in setting up the California law, we were consultants to Duffey and Musconi, et cetera, to design the laws.

    DR. GORDON: How would you rewrite this recommendation, then, Effie?

    DR. CHOW: I don't know how exactly it is stated, but add in there, "with the states and the pertinent CAM professional associations," or "licensing associations," add it right into there.

    DR. GORDON: I thought it said "offer," but it doesn't say "offer," and I think maybe that is an important item to have in here.

    MS. MILLER: No, that has to be added.

    DR. FINS: It has to be added.

    DR. CHOW: Okay, sorry.

    DR. GORDON: No, I don't see "offer" in Recommendation No. 2.

    DR. FINS: "Should offer assistance to."

    DR. GORDON: That is different from "should assist."

    DR. FINS: Right.

    DR. GORDON: So, could we put that in, please, "offer assistance"? We obviously need some more discussion. Charlotte, you have evoked more discussion. So let's continue with this. Joe.

    DR. PIZZORNO: I would like to make two recommendations. I am kind of splitting what is up there in half. So let say them both, because I think it is addressing the issues.

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    DR. GORDON: Can we respond to Charlotte's concern first. Is this a direct response?

    DR. PIZZORNO: I think I am directly responding to her concerns.

    DR. GORDON: Okay.

    DR. PIZZORNO: So let me read both these recommendations in total before people respond.

    Recommendation No. 2 should be very similar to what is currently in the book, with one major change. That is, "Practitioners who provide CAM services, and products should be regulated by the states using" -- cross out "standard" -- "in an understandable framework that assures accountability to the public, and that contains provisions for regulation, licensure, and exemptions."

    Recommendation No. 3: "The federal government should offer assistance to states and professional organizations in developing guidelines for practitioner accountability and competence in CAM delivery, including periodic review of the impact of these regulations."

    DR. GORDON: Other responses? I just want to make sure we have the responses to Charlotte's concerns. Effie raised one. Other people have any concerns about intrusion?

    SISTER KERR: My own suggestion to myself is, look at No. 2 as it is. Just for the moment, let me just say the "Federal government should assist states and professional organizations," "should assist to evaluate existing guidelines for practitioner accountability." Now, we could include, also, "offered to assist them to evaluate." My concern, which is why I am still interested in input, is, when you put in "offer assistance," which I feel better about, my sense was you all really wanted to say something else, that we fundamentally may disagree. I don't want to remove whatever the concept was. Did you all really feel the federal government should be setting these guidelines?

    DR. FINS: I really feel that was never, ever, ever the intention. I think that the text will reflect this. I think it is simply that there are certain things that the states may not be able to do because they do not have the expertise that resides in the federal government. It is really to offer technical assistance and things like that. With respect to the states, we can't mandate what the states do, because it's a constitutional issue. If the language reflects that, I think we can move on.

    Page 49


    DR. GORDON: Steve has a comment he would like to make on this, too.

    DR. GROFT: Probably about six or eight months ago -- I am not even sure -- we received a letter from the National Association of Governors that said they are looking forward to our recommendations. So they are aware of what is going on. I think it was talking with the various people outside, they are ready. They want to see it. Some states, as Joe mentioned, don't have the capability to work alone. They want to get things together that make sense for all practitioners. I think we identified the problems of going from state to state, and many states want to avoid this complication.

    SISTER KERR: Well, I don't disagree that they aren't ready for our help from their perspective, and that is good to hear. My balancing to that is that we do it in a collaborative way and that we are partnering. So if we offer the assistance, then I think that's great.

    DR. GORDON: Charlotte, does this respond to your concerns, what you've heard, or is there something missing?

    SISTER KERR: Yes, unless, again, we wanted to add in that the federal government should offer assistance to states and professional organizations in evaluating guidelines for practitioners.

    DR. GORDON: How about that, in evaluating and developing? Is that fine? Let's add that, then, okay. Are we okay with this one now?

    SISTER KERR: Wayne had something.

    DR. GORDON: Let's have agreement about this.

    DR. JONAS: I actually --

    SISTER KERR: He disagrees.

    DR. JONAS: I disagree with this direction. If anything, I think maybe the federal government should just go ahead and do it, because guidelines are guidelines, and then those are taken by states and professional societies to develop their actual regulation standards. So, if anything, I would say that the federal government should go ahead and develop their own guidelines, work, of course, with the states and the professional organizations in doing those so that there are some standards. The reasons for that is, I don't think you can have your cake and eat it too. If you are going to say, we need more access; we want to have more practice evaluations, then you also have to have accountability. This is the accountability side of it. The federal government cannot dictate that, but this is not about dictating that.

    Page 50


    DR. GORDON: Wayne, now, is this your second personality? Didn't you put this recommendation up here?

    DR. JONAS: Yes, I did, but now it is being weakened and softened, and my feeling is that the force of it will be undermined, I think, if it becomes, "Well, we would like to try to help the states out. For those that want to, we are going to have a little meeting, and then the states can come and we can talk about this," and this type of thing. I think that, then, becomes very useless.

    DR. GORDON: How would you like to reword it?

    DR. JONAS: Well, I like the wording. I mean, I will accept the wording that is in there, with some of the issues there as it is, but I don't think we should weaken it. In fact, if anything, we should say the government should facilitate the development of guidelines for practitioner accountability and competency with states and professional organizations.

    SISTER KERR: That's not taking over. That's not bad.

    DR. GORDON: Now, Charlotte, does that make you more nervous, or less?

    SISTER KERR: Well, first of all, you still haven't written in what we just said about evaluating, so put that in there. So, just to back up on that, Ken, can you put what we put, and we may take it away, "in developing and evaluating guidelines."

    DR. FISHER: Where?

    SISTER KERR: On No. 2.

    MS. SCOTT: Developing and evaluating guidelines.

    SISTER KERR: Now, I wanted to hear what Wayne has to say, which is why I was saying what I was saying. If we are going to put "should offer assistance," it isn't what Wayne thinks. We may all disagree with Wayne, but what Wayne just said to me sounded more participatory. So if you want to restate that, Brother Wayne.

    DR. JONAS: All right, just to make it clear, it is that, "The federal government should develop," and you can say "evaluate and develop guidelines for practitioner accountability and competence in CAM delivery for use by states and professional organizations in developing their practice regulations."

    DR. GORDON: How does that sound to you?

    SISTER KERR: Well, we still have the issue that they are developing for.

    Page 51


    DR. JONAS: Yes.

    SISTER KERR: I don't get it, Wayne. Why do you think they should develop it?

    DR. CHOW: Wayne, you said it different from this last time. The last time was really perfect, but this time --

    DR. JONAS: Okay. I don't mind the way it's currently written up there, and the evaluation aspect the way it's written up there. I mean, I'm happy with that.

    DR. CHOW: It wasn't the way it was written up there.

    DR. GORDON: I would like to get agreement very quickly on one version or another, and then move on.

    DR. JONAS: I don't mind the way it's up there like that. I think that that is adequate for the way it is, as far as I am concerned.

    DR. GORDON: Could you read it aloud so everyone can hear it, so we know what we are talking about? Because some people can't see it.

    DR. FISHER: Which word there? This, you agreed to.

    DR. JONAS: I would rather put "facilitate." I would say that, "The federal government should facilitate the development of guidelines for practitioner accountability and competence in CAM delivery with states and professional societies."

    DR. CHOW: Yes.

    DR. GORDON: Without those modifiers. You have Column A and Column B, too.

    DR. JONAS: You could add that on top, "including."

    DR. GORDON: Veronica.

    DR. GUTIERREZ: In the text, or maybe in a phrase at the end of that, I would like to see how this affects consumer access. I think we need to wrap that up by saying that somehow, as a result of that, there will be portability, if there is that much federal involvement, to allow providers to move between the states. Otherwise, how can it affect access?

    DR. GORDON: That may be a consequence, but I don't think that can be part of the recommendation.

    Page 52


    DR. GUTIERREZ: Okay. So we will address that separately.

    DR. FINS: We have a whole other section to do. What I would suggest, Veronica, is that for letter D under this evaluation piece, we can look at its impact on consumer access, and leave it at that. The way it was originally written, with "offer assistance," I think we could have a preamble. Maybe we can say, "Recognizing the need for accountability, the federal government should offer assistance to states and organizations."

    DR. GORDON: I don't think it is because of the accountability.

    DR. FINS: I mean, we have recognized the need to some extent, but we are not in a position to impose it. So that's why we are having this rhetorical problem.

    DR. GORDON: I think we are okay with this recommendation, rather than get into a preamble, which is going to confuse things a little more. Are we okay with this one as stated?

    SISTER KERR: If I read it to be "The federal government should facilitate the development" -- Ken, could you help us? -- "and evaluation of guidelines for practitioner accountability and competence in CAM." So we want them to just facilitate the --

    DR. GORDON: You have left out the collaborative piece with states and professional organizations.

    DR. FINS: This is not making sense, just editorially. I don't think this makes sense. I think you are actually arguing against your original point.

    SISTER KERR: I'm just trying to receive what Wayne said first.

    DR. FINS: But the federal government now is actually doing this, and it seems to impose it. Whereas, I think the original "and offer assistance" --

    SISTER KERR: They can offer to assist in the facilitation of the development. Do you all think I'm over-concerned?

    DR. GORDON: I think Joe is right, it is getting more confused. I think the way it was stated earlier was more collaborative and less of an imposition. That seemed to be what the general agreement had come to, and now we are complicating it again.

    DR. CHOW: Wayne, why don't you write what you said, instead of editing all the others.

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    DR. GORDON: Don.

    DR. WARREN: I leave to go to the bathroom, and I come back to this. I think we need to leave "assist" up there, not the other part. We need to have "facilitate the development," yes, and we need "evaluation" in there. I think we need to add B part to it, and forget the rest of it. That simplifies the wording. The states are going to regulate how they darn well want to.I

    DR. PIZZORNO: I think it's fine to put B in there, if we then go back and use a modified version of Recommendation No. 2 as Recommendation No. 3 for what is in the text on page 9.

    DR. GORDON: I think it is a question of whether we need to decide if we still want the Recommendation No. 2 that is in the text. I think we have to establish whether we want this or not.

    DR. PIZZORNO: I think we want both.

    DR. GORDON: Okay, but we are proceeding one at a time here. So I would like to get a decision on this one, and then we can go back and look at the other. Otherwise, we are just jumping around. Would somebody read the final text, somebody whose brain is not overly compounded with extranei? Anybody got it? Wayne, go ahead.

    DR. JONAS: It needs to be rewritten, but I will read it as I think it says: "The federal government should assist states and professional organizations in developing and evaluating guidelines for practitioner accountability and competence in CAM delivery."

    DR. FINS: I think, grammatically it doesn't work.

    DR. JONAS: "In delivery of CAM services."

    DR. FINS: "Guidelines for."

    DR. JONAS: "In guidelines for practitioner accountability."

    DR. FINS: "Guidelines to promote."

    DR. JONAS: "Guidelines for practitioner accountability and competence."

    DR. FINS: Maybe "to promote practitioner accountability." Again,

    SISTER Charlotte's comment about the sensibilities out there, now I want to know if

    SISTER Charlotte with this declarative.

    Page 54


    DR. GORDON: I much prefer "offer assistance." "Assist" is a little too Big Brotherish for me. I think it really will offend people, that people will feel they have to accept it.

    DR. JONAS: Who will it offend?

    DR. GORDON: I think it may offend people who feel the state is going to impinge on them in some way. I think if we are offering assistance, then it has a gentler feel to it.

    DR. JONAS: They will impinge.

    DR. FINS: I mean, if I look at professional societies in conventional medicine, as an evolved profession, they set their own professional guidelines about certification and all those various things. So I think if the American Board of Internal Medicine needed the assistance of ARHC, they would appreciate the assistance, but they would not want the imposition of guidelines or standards. I think "offer assistance" is very collegial and you are more likely to have more progress that way. So I would have a hard time with "should," but rather say "should offer assistance" to promulgate whatever we are talking about.

    DR. GORDON: Can we agree to this, "offer assistance" and the rest of it the way it is? Yes? Yes?

    DR. WARREN: With which modifier?

    DR. GORDON: Are we agreed, then, on this one, with B, the simplified ending? Okay. Have you got that? Maureen, do you have this down? Is it perfectly clear? Let's go on. Joe Pizzorno wanted to discuss the present Recommendation No. 2. It's on page 9.

    DR. PIZZORNO: So on page 9, Recommendation No. 2 would now be Recommendation No. 3, and would be, "Practitioners who provide CAM services and products should be regulated by their states using" -- cross out "standard" -- "in an understandable framework that ensures accountability to the public, and that contains provisions for registration, licensure, and exemptions."

    DR. GORDON: What I would like to hear from you is a little bit about why you feel this is necessary, and then let's have some discussion, and then let's vote up or down.

    DR. PIZZORNO: Because I think we have heard quite a bit of testimony that there are important reasons to differentiate the CAM practitioners out in the field. One of the big challenges, I think, facing the Commission has been that there is a huge variation in who these people are. Those who have proper training, standards, some research, some track record of safety, need to be differentiated from those who don't. Right now, it is, in so many places, a free-for-all. I think it is very clear that to facilitate that public safety, those practitioners with proper credentials need to be recognized so they can practice what they have been trained to practice.

    Page 55


    DR. GORDON: Let me ask you a question. Would the Minnesota law come under this recommendation as an understandable framework, as one of the possible frameworks? It would? Okay.

    DR. FINS: Can I make a modification that avoids that very simply?

    DR. GORDON: Yes.

    DR. FINS: Joe, I agree with you, and I would rewrite this with a very modest change: "Practitioners who provide CAM services and products should be regulated using an understandable framework that ensures accountability to the public and that contains provisions for registration, licensure, and exemptions, as determined by their respective state."

    DR. PIZZORNO: Perfect.

    DR. GORDON: Don.

    DR. WARREN: I personally think we ought to leave off "and that contains provisions for registration, licensure, and exemptions." I think that is redundant because you've already got regulations up there: "using an understandable framework that ensures accountability."

    DR. FINS: What I think we are trying to capture here is range of options that exist that each state will choose from. The state has a range of options for their own point of view, and also relative to each individual practitioner. You might want to have licensure for a naturopathic physician, and you might want to have registration for someone whose scope of practice is less intrusive, less dangerous, whatever. So this is simply to lay out there in the recommendation the possibilities, and then say, "as determined by their respective state," which gives due deference to the constitutional issue that the states regulate health care.

    DR. GORDON: Let's hear some other thoughts about this. Effie, please.

    DR. CHOW: I have a question. We are assuming in this that all CAM services will be regulated and have an understandable framework, not licensing. Is that right?

    DR. GORDON: It says, "licensing, registration, or exemptions." The way I read this, and please interpolate for me if I'm wrong, is that we are asking the state to set some kind of rational framework for dealing with the CAM professions, and that framework is going to vary from state to state. We are presenting licensure, registration, and exemptions as one set of criteria, although not exclusive. Is that correct?

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    DR. FINS: Yes, just a range of options.

    DR. GORDON: Don, you are shaking your head. Do you want to speak?

    DR. WARREN: States have a system to determine that.

    DR. FINS: No, they don't.

    DR. WARREN: They don't have a clue?

    DR. FINS: Sorry?

    DR. WARREN: Are you telling me they don't have a clue?

    DR. FINS: I mean, Joe is saying, and we have heard testimony, that there are some states that don't have any mechanism to provide a practice base for a range of practitioners, which leaves the practitioner unable to practice, and it leaves patients or consumers vulnerable to unregulated practitioners.

    DR. GORDON: I would like to do two things. Don, I would like you to articulate what your concern is, and then George will be next.

    DR. WARREN: I don't feel that licensure ensures public safety. I don't think that licensure ensures consumer protection, and I think we are assuming that it does. If the professions want to be regulated through licensure, they need to get that. They need to lobby their legislature and get it, but I don't think we should tell them that they have to be licensed, or suggest to the state that they just run out and license everybody.

    DR. GORDON: I want to develop the question. Do you think there is anything in this recommendation that makes sense?

    DR. WARREN: Yes.

    DR. GORDON: Do you think there should be regulation?

    DR. WARREN: Yes.

    DR. GORDON: So, what is your concern? Just with the licensure?

    DR. WARREN: If I take it and I say, "Practitioners providing CAM services and products should be regulated using a standard understandable framework that ensures accountability to the public," period, I'll take that.

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    DR. GORDON: That's another possibility. George, did you want to speak to it? Thank you, Don.

    MR. DeVRIES: First of all, the Minnesota Practice Act, I think we need to be really clear, when we were in Minnesota and we had our Town Hall Meeting, the director of the office that oversees the Minnesota Practice Act in Minnesota said that providers operating under that act were not able to diagnose a medical condition, were not able to treat a condition. So we have talked about, previously, one of the action steps, and it may be what Joe has proposed, another form of saying this is, "The Commission recommends the states require the licensure, certification, registration, or exemption consistent with the provider's education and scope of practice."

    If you consider that, if the scope of practice says they don't diagnose and they don't treat, well then, an exemption could potentially be the legislative solution. If they are a naturopathic physician who diagnoses a medial condition and treats a medical condition, they have to be licensed or they practice medicine without a license.

    I think what I am coming back to is, the Minnesota Practice Act is not a cure-all for the provider. It does not help them practice their profession.

    I believe, we need to recommend to the states that they enact the proper licensure, certification, and registration consistent with the provider's scope of practice and education. That, I believe, will address the whole spectrum of issues regarding exemption, all the way up to licensure.

    DR. GORDON: I would like to go back to Joe. Don, do you want to respond directly to that? Please.

    DR. WARREN: I like that, because it ties it to their level of expertise. But to say that the states are going to go in and license every CAM practitioner, I think that is a fallacy, and that is what I read into this.

    DR. GORDON: Joe, but then I want to come back and see which of these makes most sense. Don made an alternative proposition, you just made yet another alternative, Joe made the first one. We have three on the floor. I would like to focus on one, if we could. Joe.

    DR. FINS: I have, maybe, compromise language that accommodates, I think, everything that has been said. The one thing that I am taking out, just at the outset is "standard," because there will be no standard from state to state. That is a separate question, and it is beyond our ken.

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    DR. WARREN: You mean no uniform standard across the board? They vary state to state.

    DR. FINS: That's right. So let me try this here: "Practitioners who provide CAM services and products should be regulated using an understandable framework that ensures accountability to the public, and that contains provisions for registration, licensure, and exemptions as determined by the respective states and consistent with their scope of practice," or "appropriate to their scope of practice." The point here is that every state can say, okay, the scope of practice is A, and A is A in New York or Seattle, but Washington State might just decide to make it a licensure thing, and New York might decide registration. So it is trying to accommodate both of those issues.

    DR. GORDON: Joe, are we addressing Joe's? Okay. Because we have one compromise proposition on the floor. Let's see if we can deal with it.

    DR. PIZZORNO: I accept the friendly amendment from George and Joe to what I originally said. But, Joe, I would like to emphasize one part, which I don't think you said, and that was, I think it should be "education and scope of practice," not just "scope of practice."

    DR. FINS: Okay. I agree with that. How about "education, training, and scope of practice"?

    DR. GORDON: Is that okay, George?

    MR. DeVRIES: My only concern is it is just too long. I mean, I'm okay with it, but I think we could just simplify down to one simple statement: "We recommend the states require licensure, certification, registration, or exemption based on the provider's education, scope of practice and training."

    DR. GORDON: We spoke of regulation first, rather than licensure. We are really addressing regulation, and then we are offering different ways that regulation might take, rather than offering specific forms of regulation. So that's a slight distinction.

    DR. FINS: One way of addressing George's concern about the length of this thing would be to say, "Practitioners who provide CAM services and products should be regulated to ensure accountability to the public" -- I guess it doesn't quite work, and we have to rewrite the whole thing, but the notion of understandable framework was something that was intrinsic. We heard about that in the New York meetings and the Federation of State Medical Boards. So people understood and there was transparency.

    Page 59


    DR. GORDON: I would rather have a long statement that we can agree on right now and be finished with it, then a short statement.

    MR. DeVRIES: Can you reread it, Joe? Can you reread it?

    DR. GORDON: Read it again.

    DR. FINS: Okay, I think I've got what we said: "Practitioners who provide CAM services and products should be regulated using an understandable framework that ensures accountability to the public, and that contains provisions for registration, licensure, and exemptions as determined by their respective states and appropriate to their education, training, and scope of practice."

    DR. GORDON: "Practitioner's education, training, and scope of practice."

    DR. FINS: Right, "to their practitioner's."

    DR. GORDON: Well, it is long.

    DR. FINS: But it captures, I think, everybody's stuff.

    DR. GORDON: Julia.

    MS. SCOTT: It is long, but I thought we were going to try to get as complete as we could in terms of the intent of the commissioners, and then the writers were going to work with it. I think if we try to put every little word in here and every comma, we are going to be here until midnight. So I would just urge us to trust. I think they got it, and if they didn't, they need to tell us.

    DR. GORDON: Don.

    MR. DeVRIES: Joe, I think we're okay with that. So, is everybody okay with that?

    DR. WARREN: Don is okay with it.

    MR. DeVRIES: Don is okay with it?

    DR. GORDON: Great.

    MR. DeVRIES: All right, we're done.

    DR. GORDON: Good. Let's move on to the action items. Thank you. There are a couple of different kinds of concerns here. We can start with any action item that anyone would like. What I would prefer is, we can either relate to the ones we have here, or create new action items that better fulfill our evolving consciousness. Buford, do you want to start with the one that you were focusing on so we can deal with that?

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    MR. ROLIN: I have spoken to Steve, and what we are going to do is we are going to back to the December language, which I think we all accepted, and we will go from there on No. 8.

    DR. GORDON: Is that acceptable to everybody regarding indigenous healing practices and practitioners? I remember we had absolute unanimity in December. Okay, thank you. What else here?

    DR. BERNIER: Jim? Jim? George.

    DR. GORDON: Yes, George.

    DR. BERNIER: We are talking about the five items that are listed?

    DR. GORDON: We are actually talking about all eight of the items.

    DR. BERNIER: All eight.

    DR. GORDON: Yes. Well, let's start with one: "The Secretary of Health and Human Services should convene a National Policy Advisory Committee to address issues related to the regulation of CAM practitioners, provide guidance to the states, and provide a forum for dialogue on other issues related to maximizing access." Joe.

    DR. PIZZORNO: I think it is all consistent, up until that last clause of "maximizing access." I think it should be "maximizing public safety and health." Others on No. 1? My feeling about this is, this is where we have to begin redressing the imbalance between regulation and access, and I feel the most important part of the advisory committee is ensuring something like access to safe and effective practices and qualified practitioners. I would start with that, and then move into the regulatory.

    I really feel we need to indicate clearly that we are concerned about access as well as regulation, but let's have discussion. This is not fiat.

    [No response.]

    DR. GORDON: Is that okay with everyone? Yes.

    DR. PIZZORNO: Jim, I think what is here already written is pretty good. I am willing to live with it. I don't know about anybody else. I mean, I can modify a couple of words here and there, but it looks pretty good.

    DR. GORDON: What is written in what?

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    DR. PIZZORNO: Page 11.

    DR. GORDON: No. 1.

    DR. GORDON: You're feeling all five are okay. If we go to Nos. 6, 7, and 8, and understand the issues related to access have to be dealt with in that second part, and we understand that these are dealing with regulation, and that the order may be different and they may fall under different recommendations. Where is Joe Fins?

    DR. GROFT: He's okay.

    [Laughter.]

    DR. GORDON: He's okay with it, too? Steve is in constant telepathic communication.

    [Laughter.]

    DR. GROFT: I've got his proxy.

    DR. KACZMARCZYK: One Joe is as good as another.

    [Laughter.]

    DR. GORDON: Are we okay, then, with those first five, understanding that those are the ones that refer specifically to regulation, rather than to access and consumers? Okay. Effie has a point, and then Linnea.

    DR. CHOW: I'm okay with them, except in the very first there, "should convene a National Policy Advisory Committee, including CAM professionals," that we have been dealing in other issues, "to address issues related to regulation."

    DR. GORDON: So you would say "CAM and conventional professionals."

    DR. CHOW: Yes.

    DR. GORDON: Health professionals.

    DR. CHOW: Yes.

    DR. GORDON: Is everyone okay with that addition? Yes? Please shake your heads, or any moving part. Good. Thank you. Linnea.

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    MS. LARSON: This is simply a clarification point. About an hour or so ago, Julia suggested that taking those last Nos. 6, 7, 8, and putting them under, I believe it was the No. 1 recommendation, and then adding on one or two more. So that's all I am saying.

    DR. GORDON: We are okay Nos. 1 through 5, understanding that those go with regulation.

    DR. GROFT: Joe does have a few words here underlined, so we may have to wait until he comes back in.

    DR. GORDON: Veronica.

    DR. GUTIERREZ: Where are we going to address the portability?

    DR. GORDON: That is a whole other recommendation, or whole other action step, or it is something for the text. We need to discuss it.

    MR. DeVRIES: Portability, is it in our charge?

    DR. GORDON: If I can interpolate, the way I think we might address portability is to say that one of the reasons that national guidelines might be helpful is to encourage portability. I was on the Pew Commission that talked about this at great length, so I think that that might be a way, in the text.

    So let's come back to, now, the action items relating, more particularly, to access, Nos. 6 and 7. We have already discussed No. 8. Can we have some discussion of these action items and any other action items that need to be put in here under consumer access?

    Who would like to begin?

    [No response.]

    DR. GORDON: Should I read No. 6? "The Department of Health and Human Services and other appropriate federal agencies should use health care workforce data, data from national surveys on CAM, and regional public health reports on CAM activities to identify current and future health care needs that qualified CAM practitioners may help address." How is that one?

    MR. DeVRIES: Good.

    DR. GORDON: Okay?

    MS. MILLER: Excuse me.

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    DR. GORDON: Maureen, please.

    MS. MILLER: Only because of the tone of the report up to now, I am not sure we know what the needs are for these services. So I am just wondering if we need a little rewording here, again, in the spirit of evaluation, et cetera.

    DR. GORDON: How would you reword it, then?

    MS. MILLER: Well, I think, at the current time, until we understand some of this, another thing we could document is the geographic distribution of these practitioners, because I think it will become clear that that is an issue.

    DR. GORDON: That would be included in workforce data, right?

    MS. MILLER: I'll have to look at the text.

    DR. GORDON: The intent is fairly clear: "The current and future health care needs that qualified CAM practitioners may help address." This brings in the evaluation content here, because we are not saying that they are going to address all the health care needs, it is just a question of, is there anywhere they might be helpful. I think that is the intent here. Max, do you want to address that?

    DR. HEIRICH: I am wondering if we simply change the word "may" to "might" it might help.

    DR. GORDON: That's fine. Maureen, are we okay with this, then?

    MS. MILLER: I am just still a little uncomfortable here.

    DR. GORDON: With what? I can't tell.

    MS. MILLER: It is what the health care needs actually are. I am just not sure that the government knows enough about this.

    DR. GORDON: We don't know what their needs. If we knew the needs, we wouldn't have to do the surveys. The surveys are to determine what the needs are.

    MS. MILLER: Well, let me tell you where I come from, in my experience at least, from HCFA, in the context of access, which is, we have actual ratios, numbers of physicians to the population, say, one general practitioner per 2,000 people or something. That is what I am thinking about. When I read this, that is what I think, in the context of some people from my background, would read into this, is, we are making some statement about how many massage therapists or acupuncturists.

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    DR. GORDON: I don't know that we are. Wayne, thank you very much.

    DR. JONAS: Goodbye. I have to leave. I'm sorry.

    MS. MILLER: If that is not what is needed, then --

    DR. GORDON: I don't know that that is what is implied here. I don't read it that way, but maybe there is a way you can word it. I think what we are looking for here is, what is going on, what are the needs, and are there ways in which CAM professionals can help. It is more of an open question then saying there has to be one massage per 5,000 people, or for 50 people. So if it needs a little tinkering. Is that okay with everyone? The intention is not that we are saying there has to be a massage therapist for every 100 people, but simply to find out what the health care needs are, and then to begin to think about ways that CAM practitioners might help. Conchita, and then you, Joe.

    MR. PAZ: Well, one of the things that Tieraona was saying, is to do some of these feasibility studies. I think this would be a really good area that might benefit from some of these studies to see what the needs are.

    DR. GORDON: I thought that is what it said. Joe, go ahead.

    DR. FINS: I think there are two issues here. One is what Conchita just said, what are the health care needs above and beyond the primary care kind of needs that we have been talking about. What I would like to do is have 6(a) Action Item, to simply collate and get a sense of what the CAM health care workforce is, its characteristics, its demography, how many people are pure CAM providers, how many people are cross-trained.

    If indeed the kinds of categories that are listed on pages 2 to 3 or 4 in this report, just to get a sense of who is out there, the distribution. So that's one question.

    The other question, which I think Maureen is absolutely right about, is that we don't have a real way of matching up that data which we don't have to the identified needs yet, because we don't know what the need is for this.

    So I think that is where a demonstration project would really make sense in a small catchment area, to do a survey to get a sense of the utilization of massage and herbal therapy and chiropractic, and get a sense of, what is a small, little area doing. Then to match the workforce to the need.

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    MS. LARSON: I actually do agree with that concept. I think that the use of the term "distribution," which addresses your issue about geographic distribution, too, and distribution of discreet CAM professionals is very important. Then adding on, maybe a feasibility study and a demonstration project. I actually think we do have an opportunity here. There is already a place to do some analysis of data that is in the State of Washington.

    DR. GORDON: My concern is that doing that doesn't tell us what we need to know. What would be interesting is to see what is going on, not just in the State of Washington where it may be much more advanced, but the issue is, are there needs out there that could be met, or that are being met by CAM professionals. What are the health care needs. That is the fundamental question that is embedded here: Are there health care needs -- and I'm not sure how to get at it; I'm not trying to be prescriptive -- are there health care needs that CAM professionals could help to meet.

    DR. FINS: I think that is a really complicated question. I think it would just simpler and it would be really additive to the process if we simply tried to just characterize the CAM workforce as a cornerstone for future policy work. Whether they meet the needs or not, you wouldn't know if you didn't know who they were. So I think we could say in the text, this would be a first step to utilizing this workforce to meet as yet undefinable or undescribed needs. I think it is a more modest proposal at this late hour and it might be a way to go, and I would suggest that for consideration.

    DR. GORDON: What do people think about this? Effie.

    DR. CHOW: Using the data that is existing doesn't necessarily help us identify current and future health care needs, so I wonder if we could insert three ideas there: analysis of the data that is secured from the health care workforce, et cetera, et cetera, and if necessary establish a feasibility study or demonstration project to identify current and future health care needs.

    DR. FINS: It is also kind of vague, in a sense. Health care needs, you would specify for health promotion or rehabilitation or substance abuse. There are so many categories. I just think that we have a whole other section, and we have an hour to do it. Then there are a few other dangling participles that are left that we need to address.

    DR. GORDON: I agree, obviously, that we need to move ahead. Max, do you have a thought?

    DR. HEIRICH: It seems to me that what would be most useful would be, what health care practitioners are prepared to work on particular kinds of health care needs, for example, substance abuse. We name the needs and say, who does that kind of work now.

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    DR. GORDON: That gets closer to bringing the two parts together, the survey of practitioners and the survey of needs. Are we okay with Max fashioning some action statement that will take account of those two? Conchita.

    MR. PAZ: Well, I do want to emphasize what Effie was saying, though, to try and make sure that we have that access to the needs part brought in.

    DR. GORDON: I think it is important in these last recommendations not to lose the access piece, because I feel it tends to get subsumed again under the practitioners, and that is not the only issue here. Joe.

    DR. PIZZORNO: I want to finish this thought, and then I want to go on to a new thought.

    DR. GORDON: You want to finish this thought, okay. Are we finished with this thought? Are we okay with Max fashioning something that will take account of the possible responsiveness of CAM practitioners to a variety of health needs? Yes? Okay. Let's go on to a new thought. Joe.

    DR. PIZZORNO: I am concerned that Julia's concerns are not being adequately met, because we still have the problem of underserved populations who are wanting these services and don't have access to them. I am thinking about the community health centers as a good example. We have not addressed that.

    MS. SCOTT: Well, quite frankly, I don't think my concerns can be addressed at this meeting, unless we are prepared to stay here a lot longer. What I am suggesting is that, as a result of all of this discussion, staff has a sense of what is missing here. Referring back to some of the earlier drafts, there were definitely recommendations in there that addressed consumers.

    MS. LARSON: It was community health centers, we had a demonstration.

    MS. SCOTT: I mean, it wasn't just consumers who were low-income, or minority consumers, but definitely those groups should be included in any recommendations that we come up with. If staff feels like they want us to talk about it a little more, then we can do that, but I think it's there. It was there, and I think it can be resurrected and probably made better.

    DR. GORDON: Joe, do you feel comfortable? Where are you with that?

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    DR. FINS: Yes. It is sort of related to what didn't get in here, the fact that it is practitioner-focused and all that. It is just an editorial point, that a lot of what is on those action items on page 11 that we agreed to, don't necessarily fall in that part of the chapter, that we have things about accreditation of practitioners after we have accreditation of organizations. I think we should have some sort of logical sweep. So on page 11, for Nos. 4 and 5, it sort of relates to JACO-kind of things. I think we should just make sure we have the order correct. I think if we adopt that sort of strategy of micro-to-macro, some of Julia's concerns, which are beyond individual practitioners but relate to community health centers, and then health care systems, will not fail to get dropped out of the picture. It is also good for the logical evolution of the chapter.

    DR. GORDON: Effie.

    DR. CHOW: I know I made the comment before about the special population. In order to meet that, in this No. 6, we can add in there, "activities to identify current and future health care needs of all populations, especially underserved and special populations."

    DR. GORDON: Yes. I think that is what Max was thinking of doing. Are we okay with that?

    The recommendation that I would like to make, or the action step is -- and I don't have to spell it out, but I need to get general agreement on this -- I would like a variety of assessments of potential model programs, not just integration of CAM into conventional medical settings, but in a variety of settings, including pure CAM settings, conventional medical settings, integrative settings, hospices, community-based programs, community health clinics.

    I think this is where we can begin to respond to Julia's concerns, and I think we need to articulate it, we need to state it clearly, that we feel that there are a number of settings where we need to understand how CAM is being used, and that this would be at least preparatory to developing larger-scale demonstration programs, that we need to study what people are actually doing out there. Joe.

    DR. FINS: We were all at the Joint Commission with Michele and Steve. I mean, there is a real crying need to determine best practices. Just think about supplements in a hospital and formulary committees as an example. The Joint Commission is looking for collaboration and guidance, and we need their input, and demonstration projects. Every step above the practitioner, which I think we have done a pretty good job at, we have additional questions. It is in earlier drafts, and we will talk more in the next days about that.

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    DR. GORDON: Linnea.

    MS. LARSON: He just said what I was going to say. We have done this.

    DR. GORDON: I understand it has been in earlier drafts. What I am looking for now is agreement that we are going to be looking at what is actually happening in a number of different kinds of settings, what the benefits are, what the barriers are, what the problems are, with a view toward using this information, potentially, as the basis for developing demonstration programs. George.

    DR. BERNIER: Could we accept Nos. 6 and 7 at this point?

    DR. GORDON: We have accepted No. 6. No. 7, I would like to enlarge to include these other issues. That is, that it won't just be on integrating into conventional settings. I want the information from all of these different projects to be available.

    DR. FINS: I think that is a really important point. I'm looking where Tom used to sit; the ghost of Tom Chappell past. What I want to say here is that, in this section it is about integration because there is a health care delivery system. So there are going to be access issues that are independent. This is the hierarchy again. So you have individual practitioners who may or may not want to affiliate with a hospital or with a health care system, and they are on their own, but as you go further up in levels of complexity, inevitably you are getting into health care systems where inevitably you have to integrate, or you are separate, you are not integrated into that. These are truly issues of safe and effective integration, and you bring in issues of coverage and reimbursement and funding streams and the like.

    DR. GORDON: I would agree with you as long as we have a parallel. You are talking about convening conferences. As long as we have parallel conferences on some of the other models that are also out there.

    DR. FINS: I think that having a conference model is kind of a weak action item, and it doesn't really say much. I think there are real step-by-step operational complexity issues that need to be addressed, as you bring practitioners into hospitals and you bring CAM clinics into health care systems, into managed care plans, and on, and on, and on.

    DR. GORDON: I am saying I agree with you completely as long as we are also paying the same attention to other experiments that are taking place outside of that system.

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    DR. FINS: Right, which would not be integrated.

    DR. GORDON: Okay. Perfect. Anything else on this section? Do you have still another thought, Joe, or are you okay? Julia was your other thought. Okay. Julia.

    MS. SCOTT: And I failed to thank you, Joe. I was so busy into the response, I didn't thank you for bringing it up, and all of you for remembering those issues. Thanks.

    DR. GORDON: Don.

    DR. WARREN: We were talking about Nos. 6 and 7. On No. 7, I would like to change one word. I don't know, maybe you've knocked it out already, but it says, "conventional medical settings." Let's say "health settings" instead of "conventional medical."

    DR. GORDON: Is that okay? "Health care settings," fine. I think that, having given a good deal of work to Max and the staff, and having taken on a lot of responsibility for reviewing this as it comes back to us, we are in agreement on the points we made here. Yes? Thank you all. Max, go ahead.

    DR. HEIRICH: I just want to make one comment. I will do my best, we will do our best, to honor the spirit of what is said here. We are going to do it fast, so know that that may affect the quality of what comes out, but we will try to make it as high as we can.

    DR. GORDON: But, Max, you are also saying that if you are doing fast, you are going to need fast attention from all of us here.

    DR. HEIRICH: Absolutely.

    DR. GORDON: So that's on us. Maureen, do you want to say something?

    MS. MILLER: Yes. Can I have a bathroom break before the next session?

    [Laughter.]

    DR. GORDON: Yes. Why don't you take your break. I think we all need a five-minute break, and then let's come back.

    [Break.]

    DR. GORDON: We want to begin with No. 2 that was left over, related to National Health Service Corps, scholarships, et cetera, that we asked Joe Fins and Joe Pizzorno to work on. Where is Joe K.?

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    MR. DeVRIES: Chair, I am wondering if we should at least get through Coverage and Reimbursement.

    DR. GORDON: This is going to take a few minutes, but since Joe K. is not here, we will move ahead with Coverage and Reimbursement, and then we will come back to this issue at the end. One thing I want to say, Maureen, is, I think this is an indication of the great faith and trust we all have in you to have left the issue, and in what you have done with this section, to have left this issue until the end.




    Coverage and Reimbursement of CAM

    DR. GORDON: Let's take a look at Coverage and Reimbursement. Again, we will go through it, I will read the recommendation, and we will look at the action items, and then we will go back and look at the text. I know it's a lot, but I appreciate everybody hanging in. This is wonderful.

    Recommendation No. 1 is on page 13: "Evidence should be developed and disseminated as to the cost effectiveness of CAM interventions as well as optimum models for complementary and integrated care."

    I would ask everyone to read the eight action items under that, and then we will go through it and discuss.

    [Pause.]

    DR. GORDON: Let's begin with the recommendation: "Evidence should be developed and disseminated as to the cost effectiveness of CAM interventions as well as optimum models for complementary and integrated care." Are we okay with this general recommendation? Joe.

    DR. FINS: I think I would make one little change here. I was really looking to hear the economic dimension, the cost effectiveness dimension. I would just say, "of safe and effective CAM interventions." Again, the distinction I would make is that it is effective for an individual, but there are a lot of things that are effective that may not be cost beneficial. So with that caveat, I am comfortable with it. It would read, "Evidence should be developed and disseminated as to the cost effectiveness of safe and effective CAM interventions," blah-blah-blah.

    DR. GORDON: The assumption being they wouldn't get to this stage unless they were safe and effective. Is that right?

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    DR. FINS: There are also things that are safe and effective, but they may not be cost effective.

    DR. GORDON: No, no, I understand that.

    DR. FINS: Correct.

    DR. GORDON: But the other as well.

    DR. FINS: Yes.

    DR. GORDON: And that's why you're inserting "safe and effective."

    DR. FINS: Yes.

    DR. GORDON: Okay. Everybody with this?

    MS. MILLER: Actually, in some comments we had gotten from Max earlier, there is a difference between the benefit aspect, cost benefit and cost effectiveness.

    DR. GORDON: Why don't you explain the difference between cost effectiveness and cost benefits, and then we can make up our mind which we want to focus on.

    DR. HEIRICH: Businesses usually use cost benefit because they are simpler. That is, for how much you put in terms of specific benefits, how much do you get back; what does it cost you to achieve the benefit. Cost effectiveness, you tend to take into account over many years. For example, the argument about the cost effectiveness of smoking cessation programs is, if people live longer, does it cost more health care coverage in the meantime; have you really saved any money in the long run, and all that sort of thing.

    MS. MILLER: So actually, I think we need both because there is the limited benefit issue, but I think the implication of some of the health services research is that it looks at this more broadly. In fact, on another issue, are these CAM services additive, or do they replace conventional; are we saving money or is this going to end up with higher health care costs. So I think we need both.

    DR. GORDON: You are saying it should be both cost benefits and cost effectiveness. Okay, that's your recommendation. Joe K.

    DR. KACZMARCZYK: There is another usage of cost benefit. Thank you for mentioning health services research, because in that context health benefit means one or another service. It's a choice, it's either/or.

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    DR. GORDON: So, are we comfortable with having both cost benefit and cost effectiveness? Okay. Let's move on. Thank you for that addition. Action Item No. 1: "The Secretary, should convene a joint public and private taskforce to identify and set priorities for studying health services issues related to CAM, and to help purchasers and health plans make prudent decisions regarding coverage of and access to CAM." Joe.

    DR. FINS: I am just wondering if CMS might not be a good place to locate this because the major payer is going to be the government for almost everything.

    DR. GORDON: Maureen, what do you think?

    MS. MILLER: Well, since employers are moving out ahead on this, for Medicare it could be another ASBE or AHRQ or something.

    DR. GORDON: So HHS is better, from your point of view.

    MS. MILLER: Yes.

    DR. GORDON: Are we okay with this, then? Fine. Let's move on. No. 2: "Federal agencies, states, and private organizations should increase funding for health services research, demonstrations, and evaluations related to CAM, including outcomes of CAM; interventions, coverage, and access; effective sequencing and integration with conventional therapies; effective models for service delivery; and the use of CAM in underserved, vulnerable, and special populations." Veronica.

    DR. GUTIERREZ: Only, after "integration" I would add "when appropriate."

    DR. GORDON: Okay, "When appropriate." Any other emendations, questions, reservations?

    DR. FINS: We are studying the integration. We are not saying it is always appropriate. We are saying we are studying integration. So here, "when appropriate" is not the issue.

    DR. GORDON: Because we are saying we are also studying CAM interventions separately, and then we are studying integration as another category. Is that right, Joe?

    DR. FINS: Yes. It doesn't mean that we are integrating all the time, just that when we do integrate, we are studying it.

    DR. GORDON: Do you see that, Veronica? "Including outcomes of CAM interventions."

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    DR. FINS: Which could be in isolation.

    DR. GORDON: Exactly. Could be in isolation, so it doesn't always have to be integration. Thank you, Joe, for clarifying that. Are we okay with that one? Let's move on. No. 1.3: "Federal, state, and private entities should fund health services research on the costs and cost effectiveness of CAM interventions and wellness programs."

    MR. DeVRIES: "Cost benefits and cost effectiveness."

    DR. GORDON: Adding "cost benefits"? Everyone okay with this one? Okay. No. 1.4: "The Secretary should conduct a study to analyze nationally used coding processes, CAM coding systems, and the issues associated with the single-merged versus separate coding systems, and make recommendations. Further, the Secretary should facilitate implementation of the study's recommendations." George.

    MR. DeVRIES: I am not quite comfortable with the last sentence saying, "Further, the Secretary should facilitate implementation." I mean, that is a pretty bold step. I mean, it just seems like, do the study: publish the results. They are available for provider associations, health plans, and others to look at and to evaluate and potentially adopt.

    DR. GORDON: Comments on this? Yes, Don.

    DR. WARREN: Would the insurance industry then take the findings of the survey and then formulate whether they are going to use the single system, or merged system, or two separate systems and use it industry-wide?

    MR. DeVRIES: Well, if the Secretary is required to facilitate the implementation of the study's recommendations, and whatever comes out of the recommendations gets implemented, I think there are various CAM professions that would say, we are satisfied, for example, with the CPT code process and we like billing using CPT codes because it keeps us on an equivalent basis with other types of providers, conventional providers. Whereas, if this study says, gee, there is a lot of value to one-offing and going into this unique system, a CAM profession might say, we respect that recommendation but we would rather stay in the CPT code system because we think it is better for us as a profession. So, making the recommendation that the Secretary has to facilitate implementation is, maybe, a little overly restrictive.

    DR. GORDON: Okay, other comments on this? Joe.

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    DR. FINS: I think we should simply say "Health and Human Services should conduct," not the Secretary. It is not initially at the level of the Secretary, and there may be agencies within that would do the study. I think I would take that last sentence out as well. I think it is presumptuous to implement something when you don't know the results.

    DR. GORDON: Is there agreement to taking out the last sentence and accepting the recommendation of the action step, otherwise?

    DR. FINS: Without saying, "the Secretary should conduct," but "Health and Human Services should conduct."

    DR. GORDON: Saying the Department should conduct?

    DR. FINS: Right, right.

    DR. GORDON: Maureen, do you want to say why it said "Secretary" in here?

    MS. MILLER: Saying "the Department" is fine.

    DR. GORDON: "Department" is fine, okay. Let's move on. We are okay with this?

    MS. AXELROD: Just for clarification, this is a term we have used throughout the whole document, "the Secretary," because the Secretary has the authority to delegate. So, just for clarification of the other sections, do you all want that removed?

    DR. GORDON: I think it is fine to say, "the Secretary." I think this is a term of art in the government.

    MS. MILLER: It is. It is.

    DR. FINS: Then I will retract it. Thank you.

    DR. GORDON: Okay. Good. Thank you, Corrine. No. 1.5: "The National Center for Complementary and Alternative Medicine, through its clearinghouse, should provide information on health services research, demonstrations, and evaluations of CAM services and products." Basically, that is within the congressional mandate for NCCAM. We are just being very specific about it, saying give us some information about health services research. Joe.

    DR. FINS: I think that we heard testimony that people did not know how to do this kind of research, and I would like to add some kind of language, "provide information and technical guidance, including referral to appropriate agencies on health services research."

    Page 75


    DR. GORDON: I would think that would be another action item. I think it gets too confusing. If you want to make that another action item, that is fine. I think putting it in here is confusing and two issues.

    DR. FINS: It would be nice if an investigator called up NCCAM and needed help with the design of a clinical trial, they would also be able to be directed to the evaluative side to do it, if they are doing a population study or something like that.

    DR. GORDON: Actually, NCCAM has an expert in health services research on staff. Maureen.

    MS. MILLER: Well, personally, having spent 20 years at CMS, I would not want to exclude them, and I think AHRQ is also very beneficial. I think what we would want to do, and I think this is an excellent idea to add, is, we really want to increase the health services research capabilities across the board.

    DR. GORDON: I would like to put that as a separate action item. Do you want to state that? So, if we can approve this as the information piece of the action item. Do you want to make a recommendation right now before we lose it, for the other action item?

    DR. FINS: "The National Center for Complementary and Alternative Medicine should" -- you disagree?

    DR. GORDON: Maureen?

    MS. MILLER: I just think it should be "the Department," so it is broader than NCCAM.

    DR. FINS: I guess the issue is, if it is the whole department, people are not going to get referred properly. It could be in the central office.

    DR. GORDON: Do you want to explain how the process works? That may help Joe formulate. Or, how it might work, if we wanted it to work better.

    MS. MILLER: I think if the language included "NCCAM in conjunction with other federal agencies."

    DR. GORDON: So, Maureen, do you want to state it, or do you want to have Joe state it? Either one of you.

    DR. FINS: I mean, you would probably do it better. "The National Center, along with other agencies, should offer technical assistance in health services research to CAM investigators as requested or as necessary."

    Page 76


    DR. GORDON: Maureen, can you work on that a little bit? It is just about there.

    MS. MILLER: Yes.

    DR. GORDON: Do we agree on that one? Let's move on. That will be a new action item. My suggestion would be, we put it as No. 1.5, and then put the information as No. 1.6. That would be more logical. The next one is the current No. 1.6, which would be No. 1.7: "Health professionals, service, insurance, managed care, and other industry associations and organizations should provide their members with information about CAM and incorporate CAM onto the agendas of their professional meetings." Discussion about this.

    DR. FINS: I think it is sort of a silly recommendation. I mean, it doesn't do anything, it is not actionable. It is the private sector is out of our Executive Order. It doesn't help, and it keeps the numbers straight. The next won't be 1.7.

    [Laughter.]

    DR. GORDON: Maureen, do you want to explain why it was in here as an action item?

    MS. MILLER: Well, in this whole area of information and lack of information out there, I think it has been there all along, not as a major action step or recommendations but as a minor wake-up call to the industry to say, hey, come on, guys.

    DR. FINS: How about if we put it in the text? Because it is really not actionable in the context of the Executive Order. We could say, "Along with the recommendations." I mean, this language could just be lifted and put in the text. It would be more appropriate as text versus an action item. I mean, it is not a major point, I really don't care about it.

    DR. GORDON: Any other discussion on this?

    MS. MILLER: I wouldn't fall on my sword, either.

    MR. DeVRIES: I'm not sure how you would get this done either, other than providing encouragement, and most health plans aren't going to provide information about something that maybe they don't have expertise in, or that there is not a reason to provide.

    DR. FINS: No. 1.7, actually, more effectively achieves the goal of 1.6.

    DR. GORDON: Let me get a sense of the Commission. Are we okay with putting this one in the text? Yes? Yes?

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    COMMISSION MEMBERS [En masse]: Yes.

    DR. GORDON: Okay. Then, No. 1.7: "Public agencies and private organizations should support the development of informational programs on CAM targeted to help plan purchasers and sponsors, health insurers, managed care organizations, consumer groups, and others involved in the provision of health care services." So this is something that the government can do to connect with private industry, insurers, et cetera. Are we okay with this one?

    DR. WARREN: So we are not telling them what to do, we are just giving the information and making it available so that they can make their informed decisions?

    DR. GORDON: Yes. Okay? Good. No. 1.8: "Congress should request periodic reports from appropriate federal departments of the status of and impediments to coverage and reimbursement of CAM services and products for federal beneficiaries, federal employees, military personnel, veterans and eligible family members, and retirees." Seems like an action step to me. Are we okay with this?

    DR. FINS: Jim?

    DR. GORDON: Yes.

    DR. FINS: Line 29, "of CAM services and products demonstrated to be safe and effective."

    DR. GORDON: Is that okay with everyone?

    DR. WARREN: Wait a minute, this is just a report, isn't it?

    DR. FINS: Yes, but it is not reimbursement of all CAM services.

    DR. GORDON: Actually, I think I might disagree on this because I think it might be better if we had a report on everything and they explained that we are not covering this because it is not safe and effective, and that would be the reason. So, for example, if somebody says, "Well, are you covering interdimensional pedicures?" They would say, "No, we are not covering it because it is not safe and effective."

    [Laughter.]

    DR. GORDON: You haven't had one of those yet? Do you understand what I am saying? What we are interested in is what they are doing, what they are not doing.

    DR. FINS: Right, but when you say on Line 28, "impediments," you are implying that those things should be covered. It reads like, barriers towards.

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    MR. DeVRIES: Another way to look at this, too, is that this would require reporting on literally hundreds of therapies, and that is a lot to put on them when the reality is, if there was a safe and effective requirement on it, it would probably narrow that down considerably and make it more reasonable, and perhaps enhance possibilities.

    DR. GORDON: I guess I would like them to address the whole area a bit more broadly. I understand your point about "safe and effective" being there, but I would like to ask them where they are more generally than dealing with safe and effective. Maureen, maybe you can clarify how to do that.

    MS. MILLER: Well, we didn't put that in here for a couple reasons. One example is, the Veterans Administration is currently very innovative, and they are providing, on a site-by-site basis, various CAM therapies, probably most of which have not been demonstrated as safe and effective. Likewise, OPM, for the federal employees, basically told all the bidders on the Federal Employee Benefits Program that they could develop whatever packages they wanted, and again, this may include things that haven't been proven.

    DR. GORDON: Joe.

    DR. FINS: I have got, maybe, language that might help here: "Congress should request periodic reports from appropriate federal departments on the status of CAM benefit packages for federal beneficiaries, federal employees, military personnel," et cetera. Basically, what you are doing is you are getting a periodic snapshot of what the benefit package is for analysis.

    MS. MILLER: That is one aspect of this, but the big thing for most of the federal agencies that I think will move coverage and reimbursement forward is understanding what the impediments are, such as CMS will outline their legislative barriers, "The 55 benefit categories do not include CAM services." I mean, these reports don't necessarily have to be huge or long, but they can outline that the current legislative authority for Medicare limits the benefit categories and the types of practitioners who can receive reimbursement under Medicare.

    DR. GORDON: I think unless we do this we are not going to get the information we want. They can simply say, "This is not safe and effective, so we are not covering it." That's fine. Or, they can say, "We are covering it even though it is not safe and effective." We want all those pieces of information, and I don't want to exclude that.

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    DR. FINS: I think there is so much confusion in this one recommendation. I mean, there are lots of different elements. I know what you are intending, I know what I am intending, and I know what Maureen has just said. I agree with the sentiment of what you want to do.

    DR. GORDON: Could we let Maureen look at it a little more?

    DR. FINS: I think that is a good idea.

    DR. GORDON: If we are all agreed with the sentiment. Effie, yes?

    DR. CHOW: Yes. I agree that we should include everything and not limit it to "safe and effective, established," to get the kind of data that we would want.

    DR. GORDON: Because I think this is really important. The VA, as Maureen says, is using many different approaches that are not safe and effective. Why not find out what they are doing? They are already covering them, so we ought to know what is going on with them.

    DR. FINS: Let's move on.

    DR. GORDON: Thank you, Joe. Recommendation No. 2 on page 20: "Purchasers, insurers, and managed care organizations should extend health plan coverage to safe and effective CAM services and products provided by qualified practitioners." Everyone look over the items, please.

    [Pause.]

    DR. GORDON: Let's look at, first of all, the recommendation. How are we with the recommendation?

    DR. FINS: I think it is too prescriptive. We are telling the private sector what to do, and it is really their purview. I just think it is a bit of an overreach. Maureen, I think we had language last time about a mechanism for CMS and for other entities to make a judgement about whether things would be included or not, and if they were safe and effective they should be considered for inclusion, the same process without bias. So, it seems to me that is what this recommendation should convey, to say that they should.

    DR. GORDON: Maureen, do you want to say a few words about this? Then let's hear other comments about this recommendation.

    MS. MILLER: This is the recommendation, not the action steps?

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    DR. GORDON: The recommendation right now.

    MS. MILLER: I'm sorry, I was distracted.

    DR. GORDON: Did you hear Joe's concern?

    MR. DeVRIES: I will offer a comment. Would that be all right?

    DR. GORDON: Go ahead, George.

    MR. DeVRIES: In the subcommittee there was a lot of back and forth, and there was an opinion which said, well, if it is proven safe and effective, then health plans absolutely ought to offer it. I think where Maureen and I came out is, and I don't mean to skip down to the action item, but if you read that carefully, what it says is, really, health plans and insurance companies would basically offer purchasers the opportunity to purchase coverage for safe and effective CAM interventions. It doesn't mean that the health plan would be mandated to automatically provide coverage and benefits for everybody, but that they would basically at least make it available and let purchasers purchase additional coverage for the services. In some cases, some health plans will do it for everybody, and some groups, like Federal Employees, will do it across the board, also. Maureen, is that a fair statement?

    MS. MILLER: That is very true. I might add to what you are saying, for the general consideration here, that we had this exercise in editing for this meeting the whole report, under the direction to take out the word "consider," like "we should consider," and "as appropriate," those kind of things, so that we are more bold. Now, I have to say, in one of the last, final edits, I had left that in this recommendation because I thought we were getting a little too far out ahead. What Max just distracted me on is this issue of, will we be causing inflation in health care by saying, you have to provide all the conventional stuff and now you have to add this. So, I just put that out there for your deliberation.

    MR. DeVRIES: If we look at the recommendation and if we were to say, "Insurers and health plans should offer health plan coverage to safe and effective CAM services and products provided by qualified practitioners to purchasers," period, that basically is saying it is not mandated but the health plans would offer the benefits, and then the purchasers would have the option of purchasing them.

    DR. FINS: I agree with that completely, because this looks like you are requiring them to do that.

    MR. DeVRIES: Yes. The recommendation doesn't match the action item.

    Page 81


    DR. FINS: Right. What you just said, can you just read it? Because I want to add something at the very end of what you said.

    MR. DeVRIES: What's that?

    DR. FINS: Repeat what you just said, George.

    MR. DeVRIES: "Insurers and health plans should offer health plan coverage for safe and effective CAM services and products provided by qualified practitioners to purchasers," or maybe it should say they should "offer health plan coverage to purchasers of safe and effective CAM services."

    DR. FINS: Keep purchasers and say "for their consideration."

    MR. DeVRIES: "For their consideration."

    DR. FINS: Because the real issue here is that if it has been documented to be safe and effective, they should develop benefit packages that could be offered in the panoply of benefit packages that they offer.

    MR. DeVRIES: Exactly. Exactly.

    DR. GORDON: I want to get other reactions to this from anyone else, concerns about this.

    DR. BERNIER: Jim?

    DR. GORDON: Yes, George.

    DR. BERNIER: I guess the one concern is if you took one from Column A, and two from Column B for your coverage, would that be safeguarded in this picture? It is.

    MS. MILLER: If I might, just before we go too far down this road, at one point we had this broken up into two. We had one thing for health plans, for insurers and managed care companies, and one for purchasers, because if this replaces Recommendation No. 2, the problem is, a lot of the government agencies because for their benefit packages they don't go to insurers and managed care companies. They are the purchaser and the insurer. So, we need a second recommendation.

    MR. DeVRIES: Do you need a second recommendation, or can you simply say, "Health plans, insurers, and administrators shall make available to purchasers," whether it is on an insured basis or a fully self-funded basis?

    Page 82


    MS. MILLER: Well, I would have to think about this, but what comes to mind is TriCare for the Defense Department. I don't think they are just an administrator, they actually provide services, too.

    MR. DeVRIES: Right. But ultimately, even if it is a government agency and they are the purchaser, they make the ultimate choice of whether to add coverage for a particular benefit or not.

    MS. MILLER: In some cases they would decide, and in some cases Congress would have to decide.

    MR. DeVRIES: Congress would decide, right.

    DR. GORDON: Maybe other people want to enter the discussion. Effie, you had your hand up. No?

    DR. CHOW: I'm sorry, I have to leave you.

    DR. GORDON: You have to go. Thank you. Bye, Effie.

    [Applause.]

    DR. GORDON: Let me raise one question for consideration. Why wouldn't we want to mandate safe and effective CAM practices the same way we would mandate safe and effective conventional practices, just out of curiosity?

    MR. DeVRIES: There are safe and effective conventional practices that aren't covered under some benefit plans. So it isn't required on the conventional side, necessarily. State by state, there may be, for example, legislative regulation in a particular state regarding a particular type of insurance plan or health plan that will require a minimum set of conventional medical benefits, but that does differ from state to state and it is not always consistent. So you don't have a package of conventional services and products that are mandated or required. If you are going to be consistent with that practice and apply it across to complementary health care, it seems like we would lose credibility saying it is mandated.

    DR. GORDON: I just wanted to clarify that. Thank you.

    MR. DeVRIES: Sure.

    DR. GORDON: So, where are we now? Maureen?

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    MS. MILLER: Well, I think, because of the complexity and trying to distinguish between purchasers and purchasers, employers as purchasers and Medicare as a purchaser, we had come up with this recommendation that was a bold, out-there kind of statement. Is part of what I am hearing, people think it is a little too bold? Because then the action steps went on to clarify specifically what each of those pieces could do.

    DR. GORDON: If George's amendment works for everyone, would the action steps then work as well? Or, could we modify the action steps? Let's talk about your amendment and see if that is appropriate or not, and then we can go on and deal with the action steps.

    MR. DeVRIES: On the recommendation, you could actually say, maybe something like, "Insurance companies, health plans, and government entities should." Maybe we can go with the original and go through the action steps and see. Maybe it will work. I am withdrawing that as I think about it.

    DR. FINS: One of the problems is, what is the basic benefit. I mean, this is a question that has plagued the universal axis question forever, and we are not going there. The issue is, we don't compel insurance companies to offer a coverage for everything on the conventional side, even if those things are safe and effective. Like, bone marrow transplants may not be covered. It was demonstrated in the mid '90s. Before new data came out, breast cancer was thought to be treated, refractory breast cancer, with a bone marrow transplant. We did not compel managed care companies to cover bone marrow transplants. Subsequently, there were some cases and it got compelled, and then it got retracted. So, I think George's point that this is often regulated by the states. I think what we are trying to say here, which is a more generic thing, is if a CAM product or service or intervention has been demonstrated to be safe and effective, the standard by which an insurance company constructs its benefit package should not be unduly prejudicial against the CAM intervention simply because it is a CAM intervention.

    DR. GORDON: Why not say it in a more positive way. I understand exactly what you are saying. I thought George's recommendation was coming in that direction, the way he was amending it was coming in the direction you are talking about, Joe. So, I wonder why you are withdrawing it. I thought you were modifying this and making it more gentle and less compelling.

    MR. DeVRIES: I was, but on the second round of the amendment I was trying to somehow work into it government agencies as well as private insurers and health plans. I think Maureen was indicating earlier, she had tried that earlier and it is hard to blend the two. You have one or you have the other.

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    DR. GORDON: Why not have one recommendation that has to do with government agencies, and one recommendation where we have a different authority, perhaps, and another recommendation that has to do with the private sector where we have less authority.

    MR. DeVRIES: Right.

    DR. GORDON: Does that make sense?

    MS. MILLER: It does. Then these action steps would be under both recommendations?

    DR. FINS: Yes.

    MS. MILLER: The other thing that may happen is, the action steps may go away, because I think we are turning some of the action steps into recommendations, like if you look at No. 2.2.

    MR. DeVRIES: Right.

    SISTER KERR: What I want to say, and this is certainly not my strength or the hour, but just to give the example of what I deal with clinically, Marylanders who have Blue Cross and Blue Shield, certain aspects of the policy, they are covered with acupuncture, but the government employees who work in Maryland, because the policy is from Washington, and Blue Cross and Blue Shield, don't have acupuncture covered. What I am wondering is -- I kind of just lost it. It is like the issue of reciprocity again, and licensure, how can you have the same policy in one state? I am not sure that is accurate, but say they are the same Blue Cross -- you probably would know -- is the exact same policy. One is purchased in Washington and one is in Maryland, and one patient gets payment and the other doesn't.

    MR. DeVRIES: In that particular case, I don't want to generalize, but you have got state insurance laws which may mandate, for example, something like acupuncture. So a local employer in that state who buys coverage from that insurance company would have coverage. Now, if it was a large corporation in that state, or one, perhaps, that was a national company that qualified with self-funded under federal ERISA guidelines, then they are preempted from the state insurance laws and mandated benefit coverage, have more freedom in creating their own benefit programs.

    DR. GORDON: I would like to move through these in some expeditious way.

    MR. DeVRIES: I agree with that.

    DR. GORDON: Joe, yes.

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    DR. FINS: I think that we are confusing two issues here. Charlotte's question is a nice example of it. You are not compelling people to purchase it, you are just requiring that it be offered, and that is really what the recommendation is about. So the problem would be if Blue Cross didn't want to offer it -- but they are obviously offering it because they have two different plans -- but the purchasers have decided in one case to include it, in another case not to include it. So we can't compel the purchasers to purchase, but we want to say that the plan should offer the options, and that is really as simple as it gets.

    DR. GORDON: George, I think your recommendation did that. I would like to come back to that recommendation and see if we can agree with it, and if there are little wrinkles that need to be worked out for some of these specific action steps, I would like to deputize Maureen to work them out.

    SISTER KERR: Can I just say, back to my point on the federal, why Maureen, I think, had singled out before, is it just true we can't say any more? For example, what we want to say is to the government, hey, how do you all get out of this, and the answer you are giving me is, they have a right to not purchase it, right? And that's just the answer? We can't request anything any differently than another purchaser who just decides not to buy something, even though it is unfair, unjust, and un-American?

    [Laughter.]

    MS. MILLER: Especially if it is unjust, unfair, and unAmerican.

    MR. DeVRIES: How do you really feel,

    SISTER Charlotte?

    [Laughter.]

    MS. MILLER: It has been discussed before, the Commission could recommend that all federal programs and federal purchasers, such as Defense and VA, cover safe and effective CAM, you could. It is overly simplistic, and it had been thought of in the past as overreaching. It could change today, but it is overly simplistic because you really, then, have to go to Congress and make a recommendation that Congress change the laws with regard to these federal purchasers. Just as a point of clarification, it is not only optional for purchasers to do these things, and we may say they should do it, but it remains optional that health insurers and HMOs offer this.

    DR. FINS: I think we are making a contribution by simply saying it should be offered for their consideration.

    Page 86


    DR. GORDON: George, let's hear that again, okay?

    MR. DeVRIES: "Insurance companies and health plans should offer health plan coverage to purchasers for their consideration of safe and effective CAM services and products provided by qualified practitioners."

    DR. GORDON: We okay with this?

    DR. FINS: They should offer benefit packages that include.

    MR. DeVRIES: How about if we say, "offer benefit plans"?

    DR. FINS: Sorry?

    MR. DeVRIES: "Offer benefit plans."

    DR. GORDON: "Benefit plans." Okay, are we all right with this? Let's move on, then. Action Item No. 2.1: "Health insurance and managed care companies should modify their benefit design and coverage processes in order to offer purchasers products that include safe and effective CAM interventions." That is an action item. Do you want to address that? Don.

    DR. WARREN: Boyd brought up an interesting thing. If this plan is offered for services and products, does that mean that the beneficiaries could only purchase from practitioners? Say, it is nutrition, could they purchase from a health food store and still be covered?

    MR. DeVRIES: That is really going to depend, I believe, on the health plan and the insurance company. If it is an indemnity product, the member can go anywhere. If it is an HMO, HMOs are going to go out and contract with providers or facilities to render those services or products for them. So, it is really going to depend on the type of health plan, insurance company, the type of coverage that the member is being offered.

    DR. WARREN: Will we then just forget about products, and just say CAM services, and then spell it out?

    DR. GORDON: It says "CAM interventions" right now. "Product" is a confusing word here because it is not a CAM product, it is an insurer's product, right?

    DR. WARREN: What are you saying?

    DR. FINS: Why don't we call it "benefit package."

    DR. GORDON: Yes, call it "benefit package."

    Page 87


    DR. WARREN: A CAM intervention. CAM benefit.

    DR. FINS: No, it is a benefit package that includes CAM stuff.

    DR. WARREN: Okay, but do we have to delineate services and products, then if you say "CAM benefit package."

    DR. FINS: Right.

    DR. GORDON: You're saying, when it comes to the word "intervention," you want to delineate services and products.

    DR. WARREN: Yes.

    DR. GORDON: Why not just leave it as "interventions"?

    DR. WARREN: I am in the recommendation. I am still stuck in the recommendation.

    DR. GORDON: Oh, you are still stuck in the recommendation. I'm sorry.

    DR. WARREN: Yes. I mean, we have got interventions, interventions, interventions. Can we just put "effective CAM interventions" in the recommendation? That way we don't spell it out and somehow possibly preclude somebody from going to a health food store.

    DR. GORDON: Is this all right with everybody? I would like to complete the recommendation. Do we have it complete?

    DR. WARREN: Complete.

    DR. GORDON: Joe, have we got it complete?

    DR. FINS: Yes.

    DR. GORDON: Let's go to No. 2.1. What do we feel about that action item? George.

    MR. DeVRIES: I would change Line 12 to, "offer purchasers benefit plans that include."

    DR. GORDON: "Benefit plans."

    DR. FINS: I just say, "for their consideration," again. It is in no way to be prescriptive or a requirement, "for their consideration."

    Page 88


    MR. DeVRIES: That is good.

    DR. GORDON: Are we all right with this? Let's go on to No. 2.2: "Employers, federal agencies, and other purchasers and sponsors should enhance" -- a word that some people don't like -- "the processes they use to develop health benefits and give consideration to safe and effective CAM interventions."

    MS. MILLER: If I might make a technical point here, given the change in the recommendation where we are now focusing on health insurers and managed care organizations, No. 2.2 doesn't fit here anymore. It almost needs its own recommendation.

    SISTER KERR: Isn't that taken care of under Recommendation No. 2?

    MS. MILLER: Well, again, health insurers and managed care companies are very different from purchasers.

    DR. GORDON: You're saying we have eliminated purchasers from the recommendation. Why did we eliminate purchasers?

    MS. MILLER: You have to ask George.

    MR. DeVRIES: Well, we can put purchasers in there.

    DR. GORDON: I don't see why not.

    MR. DeVRIES: Well, the only thing is, is if we are recommending a different process for government agencies, but it sounds like we are not. At first we were, but it doesn't quite read right to say, "Government agencies should offer health plan coverage to purchasers," because that is the way it would read. It doesn't read quite right.

    DR. FINS: There are two issues. The first, if I may, big issue was that when you construct your benefit packages, options, that you include this stuff. This here is, how do you make the choice about whether or not you are going to purchase this or not, which is a whole different kind of question, as I read it. This is like whether we are going to buy it or not, whether we are going to include it. So there are two steps here. One is, that if you are a company, you are a simple company, and you want to purchase these options, the first set of recommendations was your insurance company include these options in the available products that can be sold to you.

    MR. DeVRIES: I was just going to say, No. 1.7 previously, on page 14, almost seems like what we are trying to accomplish here: "Public agencies and private organizations should support the development of informational programs on CAM targeted to purchasers."

    Page 89


    DR. FINS: "Informational programs" is different from "providing benefits," which is what No. 2.2 does. It is different, providing information is different from providing benefits.

    MR. DeVRIES: Yes.

    DR. FINS: Maureen, even though this is different from the recommendation, why couldn't it stand nevertheless?

    MS. MILLER: It could. It lessens what the Commission is saying to purchasers, but again, if that is your choice, it can stay down here as an action item.

    SISTER KERR: What is the difference here? I mean, why do you say that, Maureen?

    MS. MILLER: Well, the recommendation is a recommendation toward the Aetnas, the Blue Crosses, the Kaisers, insurers and managed care organizations. It is not addressing Ford Motor, Proctor & Gamble, Medicare, Medicaid.

    DR. GORDON: Maureen, what about to, maybe, simplify? I just make this as a suggestion, to have another recommendation that would address the purchasers, have those two up ahead, and then all of these could fit under as action items. Then we wouldn't get so complicated.

    MS. MILLER: Yes, exactly.

    DR. FINS: I think there is a real confusion between the products that are offered, which we have just been discussing, and then how a purchaser decides whether or not to include it or not. So I really think they have to be disaggregated.

    DR. GORDON: George, could you frame a recommendation for purchasers that we might use?

    MR. DeVRIES: Sure.

    DR. GORDON: Can you do it --

    MR. DeVRIES: Right now?

    DR. GORDON: Yes.

    MS. MILLER: I think we could use as a basis No. 2.2, because No. 2.2 is it.

    DR. GORDON: Okay.

    MS. MILLER: You could elevate it to be a recommendation.

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    DR. GORDON: That would be fine.

    SISTER KERR: I just want to further clarify for my own learning. I think I am still confused on purchasers, George and Maureen. Is it true, then, that there are basically these categories, like Maureen just said, the Aetnas, the managed care, and then Ford and the government are just purchasers who have their own policy, their whole own deal?

    MR. DeVRIES: Whether it is Joe's Manufacturing with 50 employees, or a dry cleaning shop with five employees, or Ford, or the federal government, they all purchase health care for their employees.

    SISTER KERR: Okay. The government, then, is in that same relationship with them.

    DR. GORDON: May we fashion No. 2.2 as another recommendation that relates to the purchasers?

    MR. DeVRIES: So, are you saying that, "Purchasers should enhance the processes they use to evaluate and purchase health benefits and give consideration to safe and effective CAM intervention benefit plans"?

    DR. GORDON: That sounds fine to me. I mean, it is a modest recommendation.

    DR. FINS: The No. 1.7 recommendation is actually less global and probably more effective in achieving the consideration.

    MS. MILLER: No. 1.7 is totally different.

    MR. DeVRIES: They really are accomplishing different things. I mean, I thought we were going a different direction when I steered you back to No. 1.7, but hearing where the Commission is at, I think amending No. 2.2 the way we just did will accomplish that.

    DR. GORDON: If we can do that, if we can agree to that, then we can take a look at the rest of the action steps.

    MR. DeVRIES: Sure.

    DR. GORDON: Which I would like to do, if we can. Charlotte.

    SISTER KERR: The only consideration I have is, could we get a more action thing on "should enhance the process." What do we want them to do, revisit the literature, reconsider safe and effective, evaluate, or is that okay?

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    DR. GORDON: I think George had a different wording. Say it again, George, for No. 2.2.

    MS. LARSON: You said, "to evaluate the processes." That is what you said.

    MR. DeVRIES: Yes.

    MS. MILLER: It is stated here very generally because, again, because this is a private system of mainly employer-based, but also, even within the government -- every government agency does this differently -- it is basically, you have a couple thousand different coverage processes.

    MR. DeVRIES: Everybody does it differently.

    MS. MILLER: Everybody does it differently. We have made some general statements in the text to give people a feel for what this is, but there is no standard way of doing this.

    DR. GORDON: How can we word this, then, please?

    MR. DeVRIES: "Purchasers should enhance the processes they use to evaluate their health benefits and give consideration to the addition of safe, effective CAM intervention benefit plans."

    DR. GORDON: Maybe a simpler way would be to say, "Purchasers should evaluate the possibility of giving benefits to safe and effective intervention." I am just thinking of trying to simplify it, because Charlotte's concern is that "enhance the processes" is vague. If we just say, "should evaluate the possibility of developing benefits and evaluate."

    MR. DeVRIES: "Purchasers should evaluate the possibility of offering health benefits for safe and effective CAM interventions."

    DR. GORDON: Yes. Is that okay? There we bring in evaluation, and they are taking a look at it, and that is all we are asking them to do. Charlotte.

    DR. FINS: It dovetails with No. 1.7, and that will help them, informationally, with that delivery of processes.

    SISTER KERR: My comment wants to follow only if we feel that we have come to closure on this, even though it is related. Is that okay?

    DR. GORDON: Have we come to closure on this?

    DR. WARREN: Let's hear it one more time.

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    MR. DeVRIES: I think you are just doing this to see if I keep remembering it.

    MS. MILLER: You are doing good, George.

    MR. DeVRIES: "Purchasers should consider the possibility" --

    MS. LARSON: "Should evaluate the possibility."

    MR. DeVRIES: Thank you. Thank you. "Purchasers should evaluate the possibility of adding" --

    DR. GORDON: "Enlarging health benefits to include safe and effective CAM interventions."

    MR. DeVRIES: Good.

    DR. GORDON: Okay?

    MR. DeVRIES: I hope that is written down.

    MS. LARSON: "Of enlarging health benefits," not "adding"?

    MR. DeVRIES: No, no, "Of adding health benefits."

    DR. GORDON: Fine.

    MR. DeVRIES: "Of including health benefits."

    DR. GORDON: "Of offering health benefits that include safe and effective CAM interventions."

    MR. DeVRIES: Better.

    DR. GORDON: Okay? We are back to the "offering" word. We have the "evaluation" word. We have them all there. Are we okay with this now? Charlotte, you have another issue.

    SISTER KERR: Yes. This is going to be a little bold, so we are either going to up it or out it. I really feel like I have to speak this for the speaking I've heard from people for so many years. I am aware, also, of what we have said, but I am going to say that I would like to know if we want to include an action statement that specifically asks Congress to revisit the benefits of federal employees as regards the inclusion of safe and effective CAM. That may not be the right wording, but it is going beyond what we have just said to say, give them an option, bring it to their consciousness. People ask for this, and I don't know if we want to do it or not.

    DR. GORDON: Specifically, what would you like Congress to do?

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    SISTER KERR: Well, I understand that the federal benefits have to be mandated by Congress, the changes. What we have said so far is that we should treat the government like we have treated other purchasers. So the request is, do we want to say to Congress, hey you all, take a look again, and do we want you to revise what you purchase for federal employees. How come you are waving your head, Boyd?

    DR. GORDON: Julia.

    MS. SCOTT: This is just process. I think we should discuss new things, but I do think we need to get through the ones that are here. George already mentioned some time constraints, and other people. If we could just quickly go through the remaining three and then come back to any additions.

    DR. GORDON: No, we have many more. We've got seven.

    MS. SCOTT: No, we are down to two. Oh, Lord, I didn't even see those.

    DR. GORDON: The only reason to address this one here is that it fits in with No. 2.2. I appreciate and I understand the time constraints. So let's see if we can move extremely fast through the rest of them and come back.

    No. 2.3: "Including CAM practitioners and experts on advisory boards, work groups, et cetera, considering CAM benefits." Yes? Okay?

    No. 4: "CAM practitioners -- no?

    MR. DeVRIES: Let's go back. Let's go back. No. 2.3, we say, "public and private organizations." Do we mean purchasers or do we mean health plans and insurance companies?

    MS. MILLER: All of the above.

    MR. DeVRIES: Because Joe's Manufacturing Company isn't going to develop a committee with a CAM practitioner to decide on a benefit plan. So I am just saying maybe we can encourage health plans and insurance companies to do it, but to say to a purchaser that they are going to go through this process for benefit development for the vast majority of employers, they won't go through this.

    DR. GORDON: So, George, what would you like to say?

    MS. MILLER: If I might, it is not intended that they have to do it. This is just, if these things exist, where these things exist, they should have a CAM expert on it. It is primarily Medicare working groups, DOD, and the large insurers, but it could be Robert Wood Johnson or somebody discussing hospice benefits or something.

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    MR. DeVRIES: Could we say something more like, if public and private organizations have advisory bodies, work groups, and committees for considering health benefits and coverage, that if they look at CAM benefits they should also include CAM practitioners in those committees? Could we say it something to that effect? Because the way it reads is, you need to have these committees.

    DR. TIAN: I think we should have these committees. We should put a little bit of pressure to the organizations; not too polite.

    DR. GORDON: I don't see that it says they should, because it is only when they have the advisory bodies, work groups, et cetera. We are not saying they should have these things. We are saying essentially the same thing you said.

    MR. DeVRIES: Does everybody pretty much see it as existing bodies and committees?

    COMMISSION MEMBERS [En masse]: Yes.

    MR. DeVRIES: All right. I will defer.

    DR. GORDON: Let's move on to No. 2.4: "CAM practitioners," et cetera, "identifying opportunities and actively seeking to participate on public and private advisory bodies, especially in areas of health services research on CAM and coverage of CAM interventions." Maureen, do you want to say a word about why this is here? Or, Julia, what do you want to say?

    MS. SCOTT: My feeling about it is the same as No. 1.6, that it is a nice thought but what can you do?

    MS. MILLER: This was put there in response to some earlier Commission discussions, that these advisory boards can create the opportunities but unless the CAM community goes out and seeks them, it is not going to happen. John White from CMS specifically addressed that. He said they put out these invitations all the time and they have never had a CAM practitioner apply.

    DR. GORDON: We need to move through these. We need a little bit of time at the end for the Joes' agreement to be presented to us, which is an important item that was left hanging. So we need to move through these in five minutes, one minute each, in order to do that. If we need to come back, let's come back afterwards. I am willing to sit and do this, but you need to go anyway, soon. Everybody needs to go very soon. So let's move fast.

    MR. DeVRIES: No. 2.4 is approved.

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    MS. SCOTT: It is approved?

    DR. GORDON: No. 2.5: "List of opportunities for CAM experts to participate." I think this is perfectly reasonable. We are moving in that direction.

    MS. SCOTT: Well, I just would like to be on record to say that I don't believe No. 2.4 should be there. I think it is something that is nice, we would like it to happen, but you can't make it happen. There is no body that is going to make it happen.

    DR. GORDON: You would like to strike it, Julia?

    MS. SCOTT: I would like to put it in the text because I think it certainly should be mentioned.

    DR. GORDON: Okay. Put it in the text, fine.

    MS. SCOTT: It is important but I don't see how we --

    DR. GORDON: Thank you, Julia. Got that, Maureen? Okay. So No. 2.5, we are okay.

    No. 2.6: "Amending the tax code to include CAM in the favorable tax treatment of health benefits."

    DR. FINS: I would recommend that we use the language to evaluate, exactly what we did in the Wellness section, and just adopt that language here.

    MR. DeVRIES: That's fine.

    DR. GORDON: Fine? Okay, got it. No. 2.7: "The Secretary should direct the agencies to convene workgroups and conferences to assess the state of the science of CAM services and products, and develop consensus and other guidance on their use." This is a recommendation, I assume, that is a function of CAM Central, if it exists. Is that right, Maureen?

    MS. MILLER: Correct.

    DR. GORDON: So, are we okay with this, then?

    MR. DeVRIES: Yes.

    DR. FINS: I think we might want to say in parentheses, "through the central office," or something, "the proposed office."

    DR. GORDON: This is in case the office doesn't exist.

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    MS. MILLER: Actually, I retract my agreement. These kinds of groups are convened primarily in NIH, but AHRQ does it and CMS does it, so it really would be the operating component.

    DR. GORDON: Thank you. No. 2.8: "Health insurers, managed care, CAM," et cetera, et cetera, "develop medical criteria, and federal agencies should support cooperative efforts to develop criteria and guidelines for the use of CAM services and products." Maureen, do you want to explain this one?

    MS. MILLER: This goes back to the medical necessity discussion that is written up in the text. It basically promotes the concept that these organizations be more proactive in developing the kind of criteria that health insurance companies need, to say, okay, we have an acupuncture benefit but that doesn't mean everybody who gets acupuncture is going to get it paid for. They do a case-by-case review for medical necessity, and those criteria are often not there.

    DR. GORDON: Are we okay with this, then, with that understanding? David, are you okay?

    DR. BRESLER: Yes.

    DR. GORDON: Joe, you okay?

    DR. FINS: Yes.

    DR. GORDON: Veronica.

    DR. GUTIERREZ: This looks like an ideal spot to insert "clinical necessity" instead of "medical criteria." Or, it could read, "to develop medical criteria and federal agencies should support cooperative efforts to develop appropriate clinical criteria and guidelines for the use of CAM."

    DR. GORDON: Is that fine for everyone, "appropriate clinical criteria"?

    PARTICIPANT: Yes.

    DR. GORDON: Thank you.

    MR. DeVRIES: Excuse me.

    DR. GORDON: Yes?

    MR. DeVRIES: No. 2.8, I mean, saying "should support" sounds like they must, and I am wondering if there is a way to make it more voluntary. No. 2.8, line 12, "should support" sounds like it is required.

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    DR. FINS: "Should foster"?

    MR. DeVRIES: "Are encouraged to support"? I realize that weakens it a little bit.

    DR. GORDON: Are we okay with that?

    MS. MILLER: As long as no one later tells me we are not allowed to use the word "encourage."

    DR. GORDON: One time is okay.

    [Laughter.]

    DR. GORDON: No. 2.9, "State governments should address barriers to third-party coverage of safe and beneficial CAM interventions that stem from the practitioner's need for legal authority to provide those interventions." Do you want to explain this, George?

    MR. DeVRIES: This is the whole issue of licensure. This is the whole issue of making sure that a barrier to third-party coverage of naturopathic services is if naturopathic physicians are not licensed to provide their services and therefore it is practicing medicine without a license. It won't be reimbursed, and it won't be covered.

    DR. FINS: What used to be that morass that was on the back wall here, from the last section, right here, where we were talking about the evaluation of the guidelines and the various implications, I think that this really follows, related to the licensure and regulation issues, whether or not it impedes or enhances access. So I would move to put that in that section because this is really an access question, not a coverage and reimbursement issue.

    MR. DeVRIES: I would actually argue back that this is such an important issue, that it is both.

    DR. FINS: Okay, you win.

    MR. DeVRIES: I don't mind taking your language, the language you proposed and we all agreed upon in Access, and incorporating it here. Maybe, Maureen, if you want to change it to fit the issues of third-party reimbursements ever so slightly. But I think it is such a broad issue, the legal regulatory ability of a provider, that it really covers both ends.

    DR. GORDON: Don, please.

    DR. WARREN: I don't understand. I see this, and I don't understand. If you are not licensed, they are not going to pay. So why do we have to put it in there at all?

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    MR. DeVRIES: Well, the issue is naturopathic services in California are not paid by any health plans.

    DR. WARREN: Are they licensed in California?

    MR. DeVRIES: No, they are not, but if they were licensed in California, I believe there are health plans that would say, okay, we will cover services provided by naturopathic physicians. So the lack of license is a barrier for third-party reimbursement for those services. Again, it kind of goes back, Don, to the whole issue of having the appropriate regulatory approval to be able to operate within your scope of practice, your training, and your education. So that is really it.

    DR. GORDON: So if this is comprehensible, there still is the question, and there is a difference on the floor, between George who feels that should be included here as well as in Access, and Joe who feels it should just be in Access.

    DR. FINS: I don't care.

    DR. GORDON: You don't care.

    DR. FINS: NO, I think it is fine.

    DR. GORDON: It's okay. All right. Are we okay with it here? Fine.

    MR. DeVRIES: So Maureen will put it in?

    DR. GORDON: In the same language as in Access. Charlotte, you raised one more that we need to address here, and then we do need to address the Joes' issue, and then I need a couple of other pieces of information from the Commission at this point. I would like a couple of other pieces.

    DR. WARREN: I go back. I vote no on that last item.

    DR. GORDON: Which last item, Charlotte's?

    DR. WARREN: No. 2.9. I vote no.

    DR. GORDON: You vote no on No. 2.9.

    DR. WARREN: Yes. I don't think it is necessary. I think it ought to be stricken.

    DR. GORDON: I'm sorry, Don?

    DR. WARREN: I think it ought to be stricken.

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    DR. GORDON: Because?

    DR. WARREN: It doesn't make sense. They are either licensed or they are not licensed. If they are licensed, they get coverage; if they are not licensed, they don't get coverage.

    DR. GORDON: I think what No. 2.9 is saying is that licensure ought to be facilitated.

    DR. FINS: I think what it is saying is that without licensure there is no hope for those individuals to be funded, and without funding, you don't have people coming to your state, so therefore you have decreased access. So it is not that we are saying they should be licensed or not. That is a different question. We have addressed that. We are simply saying that the lack of legal authority for individuals to practice has economic implications, and that is what is being raised here for questioning.

    MR. DeVRIES: This section is about third-party reimbursement and facilitating third-party reimbursement, how to facilitate third-party reimbursement. This is not about providers who choose to be exempted and to practice in a different way and do cash-only business. This is about facilitating third-party reimbursement. If you start from that premise, then it is understanding that they have to have the legal authority to practice in order to be reimbursed under third-party reimbursement, and that is what this is trying to address.

    DR. WARREN: They still have the option of doing cash-only.

    MR. DeVRIES: Of course, absolutely. We will use the same exact language we agreed upon before.

    DR. GORDON: Are you okay with that, then, Don?

    DR. WARREN: It's just like dentistry.

    DR. GORDON: What is that?

    DR. WARREN: It's just like dentistry, then. You've got the possibility of being reimbursed if are you are licensed. If you aren't licensed, you won't get paid for it, and if you want to be cash-only, you can be cash-only.

    DR. GORDON: It would be like if they refused to license dentists in Florida.

    DR. WARREN: Thank you for saying that.

    DR. GORDON: You think that should happen there?

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    [Laughter.]

    DR. GORDON: Is that right, that is sort of equivalent?

    MR. DeVRIES: Yes.

    DR. GORDON: If there is a direct obstacle to licensure for people who want licensure. Just because you have licensure doesn't mean you are going to be covered, but licensure is a prerequisite for coverage. So, is it okay here?

    DR. WARREN: Well, since it's explained in those terms, it makes more sense.

    DR. GORDON: I'm sorry?

    DR. WARREN: Since it is explained in those terms, it makes more sense.

    [Laughter.]

    MR. DeVRIES: Thank you, Don.

    DR. GORDON: For a minute, let's come back to Charlotte's.

    SISTER KERR: I have a clear position on this. I have a feeling that either it has already happened in press requests or it will be asked of the Commission. Did you all recommend to include CAM in Medicare, Medicaid in federal employee benefits? If we say no, that is an answer. If we say yes, and we say something like, "We ask Congress to revisit," which is what I stated before.

    DR. GORDON: So, what would your recommendation be?

    SISTER KERR: I am not making a recommendation. I am asking the Committee because it is very controversial. Is the answer that we have decided to include the federal government as any other purchaser, so that we have asked all purchasers to re-look at their benefits, and we are leaving it like that? This question is going to be asked.

    DR. GORDON: Charlotte, let me say where I stand on this. I don't think it is so controversial. I think it is fine. I think it is fine for us to say that Congress should consider, evaluate and reconsider whether or not safe and effective CAM benefits should be covered for federal employees. It doesn't seem to me any different in principle. We are not going any further than we are for anything else. It is the same as we are suggesting to any purchaser.

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    MR. DeVRIES: Could we suggest, maybe, creating one more action step where we would specifically say, "Congress should consider the coverage of safe and effective CAM interventions as benefit plans"?

    DR. GORDON: I would say, "Congress should evaluate the available evidence and consider the possibility of including safe and effective CAM benefits."

    MR. DeVRIES: Joe, that is not recommending. Congress is going to go through their entire financial --

    DR. FINS: I know, but I have to go in two minutes. This is a huge decision, and this can't be decided now. We have brushed up against this issue. We have decided not to go there, and at the eleventh hour it is very hard to make that decision. I mean, a third of the people aren't here. It is troubling. I think this is a big, big issue because now it opens up the issue of other things that aren't covered that Congress should consider, and the priority-setting issue. I said this at the first meeting and I will say it again now, I have a hard time endorsing things that are yet to be proven to be safe and effective against the Medicare drug benefit.

    DR. GORDON: Joe, that was not the intention of the recommendation, but I appreciate your saying it is a big issue.

    SISTER KERR: Do you agree, though, that the press and the country is going to ask us this question?

    MR. DeVRIES: Well, the reality is, in a sense we have already answered that question in the way we have worded the action steps because we have said that purchasers should consider coverage, and that includes federal government, that includes Medicare, that includes Medicaid, or the state Medicaid programs. It really does include all government programs as well as private entities.

    DR. GORDON: Conchita and Ming, we need to move ahead. We have an issue that we have got to decide while these folks are here. I don't quite know how to deal with the congressional issue. We have a difference. I see we have already said it, we just haven't said it at the level of Congress. We have said it at the level of agencies already. So I don't know that we ever considered in detail the recommendation to Congress before. I appreciate your concern at the same time, and I don't want to try to push it through.

    DR. FINS: Charlotte, the answer is, in my view, that there is no such thing as CAM coverage. It is a case-by-case intervention, and we have made recommendations whereby purchasers and funders can begin to evaluate the relative merits of individual safe and effective modalities.

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    DR. GORDON: That is right. All this recommendation would be saying is we are making the same recommendation to Congress with the same steps. So that's what I'm saying.

    MR. DeVRIES: Charlotte and Joe, we have kind of addressed both sides, haven't we?

    SISTER KERR: I think it is highlighting it by pulling it out. The other thing, and this is just clarifying, I imagine if you work for Ford or you buy into Kaiser, you feel like you participate, perhaps, in the choice of benefits. It may be the same thing with the government where, if a person asks, to say what you have to do is keep writing your members of Congress.

    DR. GORDON: What I would like to do, because of concern about this and because of its high profile, we can talk about it on the conference call when the conference call comes. I would like to address a couple of the other issues. I think Joe's point is well taken, that there may be all kinds of concerns, and I don't want to push this at the last moment.

    SISTER KERR:

    MR. Chairman, I would like to request that you hold this for us. It is not a particular recommendation that I want included, it is a particular consideration I want us to discuss. So I want to give the ownership of the responsibility to you.

    DR. GORDON: I will accept it. Ming.

    DR. TIAN: I think this is a very important issue. I do not quite understand why we cannot suggest to Congress to evaluate it. Why not? I do not want to use Congress as a purchaser.

    DR. GORDON: I agree with you completely, but let me just say that because of the consideration that Joe raised, because this is high profile, because it may make people uneasy for whatever reason, that we ought to wait until we have the whole Commission and slightly longer time, which we will have on a conference call. Then, I will bring it up on the conference call. Maureen, do you want to add anything?

    DR. TIAN: I also want to say that so many government employees, the patients ask us, many, many times, from the very beginning, at least two years. I strongly insist on my point. I think we should clearly tell Congress it should consider it.

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    DR. GORDON: Yes. In my role as the chair, I feel that without the other members of the Commission here, bringing up a new item that is at this level of profile, I think we need them here, and they need to have the opportunity to have input. Steve, maybe we can mention that this is something that has been discussed and ask people to think about it, but I don't want to push it on them because these things are so delicate that I would rather discuss it when everybody has had a chance to evaluate it. Is that okay with people? Are you with me on this? Yes, Conchita.

    DR. PAZ: We have kind of touched on it here and there, nothing directly, but here and there. I mean, we came across it with the Access and some of the studies that we talked about doing. I think those are places that incorporate Medicaid-type services. We have never really addressed it directly, but I think that will be part of what has touched it.

    DR. FINS: I disagree, I think we have discussed it. I think the issue was safe and effective mechanisms, that there is no such thing as a CAM benefit, and that is going to be particular, and there is specificity and there is a process. I think we have discussed this a lot.

    DR. GORDON: The process is the same for Medicaid and Medicare as it is in the other situations.

    DR. FINS: Right. That CMS would make this decision, if it is safe and effective.

    DR. GORDON: We need to discuss the issue that was raised before about National Health Service Corps, and we need the three Joes to do this. So, could we take a minute to do this?

    DR. FINS: This was the loan issue for the National Health Service Corps, Education 1.6. Basically, Joe Pizzorno and I have agreed on this, and it is a step-wise approach to this issue: "Health and Human Services should conduct a feasibility study to determine whether appropriately educated and trained CAM practitioners enhance and/or expand health care provided by primary care teams which include family practice, internists, pediatricians, OB/GYNs, as well as PAs, nurse practitioners, nurse midwives, dentists, and mental health professionals. "This feasibility study could lead to demonstration projects to identify, (1) the type of CAM practitioner; (2) the necessary education and training for practitioners; (3) the practice setting; and (4) the health outcomes associated with the addition of these practitioners and services to comprehensive care."

    The point here is, we are not addressing the loan issue and loan forgiveness and whether or not these people are primary care providers or not, because it is premature to do that, and that we need to demonstrate the feasibility, we have to have demonstration projects and see whether or not it is value-added. If it is value-added, at some future time the federal government might consider some additional support for the education of these individuals.

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    DR. GUTIERREZ: Did you include chiropractic in that?

    DR. FINS: Sorry?

    DR. GORDON: Thank you for your hard work.

    DR. GUTIERREZ: Did you include chiropractic in that?

    DR. FINS: Chiropractic is not defined as a primary care provider, and Congress recently decided to reaffirm --

    DR. GORDON: We have not tackled the issue here -- Joe, correct me if I'm wrong -- of who is and who is not a primary care provider.

    DR. FINS: This is not how we are going to resolve this. I mean, half the people have left and half the people are leaving.

    DR. WARREN: This is such a long statement. I would like to get a document so that I can look it over.

    DR. FINS: Okay, why don't do that.

    DR. GORDON: Let's get this in writing. This will be another item for discussion on the conference call.

    DR. FINS: I want to say one other thing.

    DR. GORDON: Yes, go ahead, please.

    DR. FINS: I want to say that all of us reaffirm our rights about our endorsement, or not, about the report based on how the written report comes to us. The second point is that we have not discussed the vision statement.

    DR. GORDON: That's right.

    DR. FINS: I think that the vision statement will make some of us have double vision, and I think we have to be very careful about that. We haven't done it, and I think that is an area that, without discussion, could really lead to an unbalancing of any kind of consensus that is evolving.

    DR. GORDON: Let me say, since I am going to be the author of the vision statement that I did not want to write the vision statement until I had heard the vision of the Commission. So it has been deliberately put off until this time so I can listen and attend to these two days of discussion. The vision statement will be sent to everybody, and there will be time to look at it and comment on it, to say what one wants to say about it. Then you can get in touch with me individually, and then I can make revisions, and then it will be back in a second iteration. So the vision statement I would have written before is not the same as the vision statement I will write now.

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    DR. FINS: I just think the report should speak for itself. The vision is in all the text that we have crafted and all the discussions we have had. To have another document with the time frame of two weeks --

    DR. GORDON: The document will be about two or three pages.

    DR. FINS: I know, but some of us had urged not to have that at all. I understand and I appreciate the fact that it wasn't written before we had this meeting because it wouldn't reflect the vision. I also want to just emphasize that, at this late hour, to introduce a new text that could not necessarily capture the sentiments around the table is something that could upset the work.

    DR. GORDON: If indeed the statement does not capture the sentiments around the table accurately, it won't be included. That is the whole point of the vision statement, is that it will capture the statements.

    DR. FINS: Okay.

    DR. GORDON: So I hope you will extend the same courtesy of evaluating it.

    DR. FINS: Absolutely. I really look forward to it, and I wish you well in doing that, but I just think that of all the elements in the report that could drift into an advocacy mode or revert back to old text. There is a risk.

    DR. GORDON: I hear your concerns, and I hope you will evaluate it with the same thoughtfulness you have extended for the whole report.

    DR. FINS: Thank you. I appreciate that.

    SISTER KERR: Jim, are you foreseeing this as just a general three-page thing, or five, or one?

    DR. GORDON: Yes. We have two other documents that none of us have seen. We have an executive summary and we have a vision statement that have not been issued. Those will be sent out to all the commission members over the next few days, as we pull together all the information from these meetings. There are a couple of other issues that are still pending which we haven't decided. One has to do with the order of the sections, and what I would like to suggest is that staff will posit a tentative order for the sections that will be submitted along with the sections.

    Does that seem right?

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    Secondly, there is an issue that Don raised that we still have not addressed -- and I don't know, we may not want to address it, but I am remembering it -- that has to do with practitioners' vulnerability to prosecution. I am just saying that this is one issue that, clearly in my mind, has been left out.

    We have it there in terms of research, but I know that you wanted to have it addressed in Access and Delivery. We didn't have a chance to talk about it. So that is something for the staff and for Max to be considering.

    DR. WARREN: One more point. At numerous times today Joe has brought up that Congress has said that the chiropractors were not considered primary care. When did that happen, how did it happen, and in what bill?

    DR. FINS: I don't have that information.

    DR. WARREN: How long ago did it happen?

    DR. FINS: Within the last couple of months.

    DR. WARREN: Last couple of months.

    DR. FINS: You should ask staff for that information. They will provide it to you.

    DR. GORDON: So, Steve, do you want to say in a few words what the process is going to be now?

    DR. GROFT: Real briefly, we are going to take what we gained from this meeting, collapse it, and try and get, hopefully, a very thoughtful document out to everyone. It will be coming out in pieces. It will not come out as one document. I think each section has a different level of revision, and we are not going to hold them all up. So please keep an eye on your Emails and get back to us as soon as possible. I will try to put a time frame on it, something like 48 hours or something, to get your comments back.

    Then, the Access and Delivery piece, which is going to be a major rewrite, we are starting Sunday to work on that, and we hope by Wednesday, perhaps Wednesday night, that we will have a draft ready to go out to you.

    DR. GORDON: I also just want to thank all of you for staying so long. Joe Fins, I want to thank you and others, who had doubts to begin with, for your commendable willingness to participate totally in the process and to be available. I have really appreciated this on all sides, all the people who sent Emails, who had concerns, have been able to come together and really work together wonderfully. So thank you all for this and for all the time that you have been here.

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    DR. TIAN: Thank you for your leadership, Jim and Steve.

    [Applause.]

    MS. SCOTT: And thank all the staff for their tireless work.

    [Applause.]

    [Whereupon, at 7:00 p.m., the meeting was adjourned.]


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    CERTIFICATION This is to certify that the attached proceedings
    BEFORE:  White House Commission on Complementary
    and Alternative Medicine Policy HELD:  February 21-22, 2002
    
    were held as herein appears and that this is the official transcript
    thereof for the file of the Department or Commission.
    
    DEBORAH TALLMAN, Court Reporter