Neuroscience Building National Institutes of Health Conference Rooms C & D 6001 Executive Boulevard Bethesda, Maryland Friday, December 7th, 2001 - Afternoon Session

Meeting Home Participants Thursday, December 6th, 2001 Contents Morning Session Afternoon Session Friday, December 7th, 2001 Contents Morning Session Afternoon Session

A F T E R N O O N    S E S S I O N

[1:50 p.m.]

DR. GORDON: We are going to begin now with Coverage and Reimbursement.

Let me amend that. We are going to talk first about the dates for the February meeting and then we are going to go into Coverage and Reimbursement.

Incidentally, I just want to say again to the commissioners I really appreciate the speed with which everybody is willing to move from one issue and location to another.


MR. GROFT: Possible dates. We are still looking at Thursday and Friday, and I think the feeling is anything after the 22nd would be too late. That would be the latest possible date. The 14th and the 15th is a possibility. 21, 22.

DR. GORDON: Is everybody on this now? We need to make a decision. Only the 14th and 15th and 21st and 22nd, Steve, at this point?

MR. GROFT: No. The 18th and 19th but I think some people said they could not be here for the 18th and 19th.

DR. GORDON: Is that true?

MR. GROFT: Are there people who can't be here the 18th and 19th? Could you raise your hand, just so we can see?

[Show of hands.]

MR. GROFT: Bill Fair.

DR. GORDON: Okay, good.

MR. GROFT: There is a fair number.

DR. GORDON: Twenty-one, 22. Steve, we don't feel that is too late? That would be okay?

MR. GROFT: No, I think we are prepared to get it completed by the 7th. Some activities, like the preparation of the final report will be done, just to separate out a couple of things.

One is the written document that we normally think of as the report will go forward by the 7th. We will then enter that document in for regular publishing and printing with all the refinements and nice accompaniment that would go with it, any pictures, the graphics, other things that we may want to do, highlighting different parts.

That is a printing issue that will continue after the Commission ends because we are not going to print until we get agreement and acceptance of the report.

DR. GORDON: Agreement and acceptance from?

MR. GROFT: First from here, and then it is cleared and signed off by the Secretary, sending it to the President and to the Congress, because we want to have those letters in as well.

DR. GORDON: Steve, are we going to come back and go through the steps from now until the final report in an hour or two, or do you want to that now?

MR. GROFT: If you have the hour here, I could easily cover them right before we go into the Public Session.


MR. GROFT: Well, do you want to talk about them now? Would that help?

DR. GORDON: Well, I think we need to let people know exactly what we are going to be doing in February, and what we are doing between now and February, and then what happens after February.

Final Report: Process

MR. GROFT: Okay. We are going to take the recommendations back that we heard from here and the work groups that have to revise them will revise them and then contact the other folks who have concerns and issues. With that, the writing of the text --

DR. GORDON: The revision of the recommendations will take place over approximately the next 10 days, okay? Everybody clear, perfectly clear on that?

MR. GROFT: We will take those and then we would like to have everything resolved, if there are any questions whatsoever, resolved by January 8th so that the final writing can be undertaken.

DR. GORDON: Any questions on recommendations?

MR. GROFT: Any questions on recommendations, right. Or if there are any problems with any section of the text that you have seen thus far we would like to ask you to send those comments back to us saying, I have got a problem with the way this was expressed or these words. I think Veronica gave us a couple of word changes today that she just felt needed to be done. So, anything like that that you found offensive or not really representative of what you think needs to be expressed.

DR. GORDON: Or issues with tone.

MR. GROFT: Yes, issues with tone. So there is a lot of writing that has to be done. Jim will be doing some writing and we have someone else to do some copy editing that will be working with us when Jim gets finished or as we are getting along. We need to get the document out to you by February 4th and 5th, at least two weeks before the meeting, at least.

DR. GORDON: And by then the recommendations will be final and the document will then be for discussion.

MR. GROFT: Right.

DR. GORDON: Okay? So there will then be a couple weeks to read the whole document at that point.

MR. GROFT: And the work groups will have read their own, individual sections as we go along between two weeks hence and then before January 8th or so. But the work groups will continue their involvement the whole way through to the end. I think that was the desire of the Commission, that they maintain that responsibility for their section of the document through.

SISTER KERR: Steve, excuse me. I heard a date of January 8th.


SISTER KERR: And I wasn't sure what that was a termination for and if it was, would we be getting whatever we are supposed to comment on at least a few days before Christmas? I mean if you are asking for some other final input by the 8th, what is it we --

MR. GROFT: I think we want to get all the recommendations resolved by the 8th of January. We want to get all of the key words or phrases that people want to have changed, that they have concerns with cleaned out and cleaned up so that as we finish up the writing we don't have to worry about those issues there.

DR. GORDON: And also, Steve, we want to get everybody's concerns about the text by January 8th. Did you follow the reasoning on that? So that if there are concerns about a specific section that that can be worked on. Meanwhile, the work group will be working on those sections of the text, and then if there are things that need to be changed or added to, then Jim or staff will be able to work with those recommendations.

MR. GROFT: Including trying to prioritize the recommendations for each section.

DR. GORDON: Well, that is a whole other issue.

MR. GROFT: That is a whole other issue that we will have to get to. And actually, we will try to do as much as we can before the February meeting, and hopefully we can bring you that final report and it will have the priorities, so we may be doing a lot of e-mailing back and forth to get your views of the priorities.

DR. GORDON: Steve, do you want to discuss the prioritization process now, too, just a little bit and how we may approach that? And then we need to discuss approximately what will happen with the February meeting, too.

MR. GROFT: Yes. We haven't even talked about that as far as trying to develop a prioritization process. I think it is something we are going to have to deal with next week and try to come up with some plans and get them out to everyone to look at.

DR. GORDON: So, a plan for prioritization I will work on with the staff. We will send that out to everybody then within the next couple weeks?

MR. GROFT: Hopefully by the end of next week we can get something out.

SISTER KERR: Where do we build in the time for whatever our role is -- it may be nothing -- for the implementation of this? Do we just, again, deposit it to DHHS, period?

MR. GROFT: That is it.

SISTER KERR: We don't do anything with strategy in Congress? Nothing?


SISTER KERR: Well, why the heck did we have a political consultant?

MR. GROFT: Excuse me?

SISTER KERR: Why did we have somebody I thought was advising us on how to move this in Congress? I thought that is what that guy was doing.


SISTER KERR: All right. Well, that is all right.

The last question I have is in March. Is that actually a day we will have as well soon?

MR. GROFT: March 7th is the end.

SISTER KERR: I mean do we gather on March 7th, then?


SISTER KERR: So, we just end it in February, right?

MR. GROFT: End it in February, yes.

SISTER KERR: We don't have any grieving process time or anything?

MR. GROFT: I don't have details on --

SISTER KERR: No hospice care?

MR. GROFT: No. I am trying to arrange some other events that you would not be involved with as commission members but as former commission members but they have not been finalized. I am working on that now and I really can't address it because we have not come to that conclusion. But if we are able to pull it off, it will be nice. It is going to be an appropriate way to present the final report.

DR. GORDON: And Steve, in February we will be working on the final text and final issues of prioritization?

MR. GROFT: I think we would like to get agreement at the February meeting on the text and the priorities that we have established and how we have presented them at that point.

DR. GORDON: Okay. And then, we will be contacting people for input about ways to educate the public about the report and to move the report forward in a public fashion, so that is something we will be doing over these next weeks, right, Steve?

MR. GROFT: We actually were going to do that at this meeting if we had enough time but we didn't have the time at lunchtime to go over the mechanism. So, again, I will write something up and get it out to everyone so we can discuss it through e-mail messages. And there will be a thread going through.

DR. BERNIER: Steve, I would just like to add that I think at this point if people start sending in comments they need to send them to everyone so we are not doing things in isolation, so that we can respond to other people's comments.

MR. GROFT: I mentioned that, that next week we will get a note out and everybody just hits a "reply to all."


MR. GROFT: So that everyone then gets it. Whatever comes in to me, if it is not forwarded to everyone, if I see the e-mail message, I will forward it to everyone, okay?

DR. GORDON: The other point I want to make again is that when staff is arranging for calls for the specific work groups everyone will get a notice. So those who want to make specific points and want to be particularly involved in a work group, there will be the opportunity for everyone who is interested to be involved in those work groups.

I just want to get one final count on particular people who may want to be involved in this division thing. Just let me see those hands again, okay? Just want to write names down.

[Show of hands.]

DR. GORDON: Okay. I have Tom, Effie, Veronica. Okay. That is fine.

And again, we will talk and whatever we do we will send out to everybody.

DR. LOW DOG: Do we have a date?

MR. GROFT: We are looking at the 21st and 22nd.

DR. FINS: Would it be possible to start on the 22nd and do the 23rd?

DR. GORDON: 20th and 21st?

DR. FINS: The 21st is my problem day.

MR. GROFT: We will try to save your concerns for the 22nd.

DR. GORDON: Joe is concerned about everything.

DR. FINS: Well, I just can't do the 21st. That is the problem.

DR. GORDON: Were there any other days, Steve?

MR. GROFT: The 14th and 15th, but I think that was a problem for many people as well. Valentine's. A lot of heads shaking there.

DR. LOW DOG: Other than Joe, is there anyone else who can't make the 21st and 22nd?

DR. FINS: Is there any way to do the earlier part of that week, the 18th, 19th, or 20th?

MR. GROFT: I think the 18th and 19th was when a number of people were not available.

PARTICIPANT: The 18th is a federal holiday.

MR. GROFT: But that was bad. Several hands, I think, went up on the 18th and 19th. 19th and 20th?

DR. GORDON: Steve, are you asking a question about the 19th and 20th?

MR. GROFT: 19th and 20th. 19th and 20th?

PARTICIPANT: I hate to be a stickler but for those of us that are making a living in practice --

PARTICIPANT: I can't answer that without calling the office.

MR. GROFT: Okay. Let's stick with the 21st and 22nd and try to accommodate Joe the best we can. Whether we can patch him through on a teleconference or something, we are going to try to deal.

DR. GORDON: I will see what I can do as well on my side.

MR. GROFT: The 21st and 22nd. Ink it in. Okay. Best we can do.

I really want to thank you because the attendance has been outstanding at all of the meetings, and we hate to have a meeting of this importance that we don't have people but I think the people who can't make it the 21st can make it on the 22nd. We will try to get those issues resolved at that point that are really major sticking issues for individuals, okay?

DR. GORDON: The 21st and 22nd.

MR. GROFT: Thursday and Friday, okay.

DR. GORDON: We are going to move ahead. We are going to do the two sections. We are going to do without a break. We are going to do Coverage and Reimbursement and then we are going to do CAM Central.

So Maureen is going to cover Coverage.

Are you without benefit of phone?

MS. MILLER: Yes. George may call in while we are doing this, but he is experiencing a delay.

I would like to say I am an extension of George at this point, not a substitute because he certainly is not one that would be easily substituted for.

DR. FINS: A little suggestion.


DR. FINS: Is George expected to call in?

MS. MILLER: He is expected, but we don't know when.

DR. FINS: Why don't we do Don first? Is that possible? Chances are he won't, then?

MS. MILLER: Yes. It is a good possibility he will not be able to call in.

Discussion Session IV: Coverage and Reimbursement of CAM

MS. MILLER: Just a quick overview of what we did since last October, from the October meeting, is that we basically kept our approach of the barriers to coverage and reimbursement, which is an approach that we identified with and people seemed to concur with, or there seemed to be a broad range of agreement on that approach at the last meeting. So we have kept that.

We have broken out one area, which is the overall fair and equitable treatment of CAM. It had been merged into each of the sections but we felt it was a bit awkward and we went ahead and broke it out as a separate section and moved a couple of the recommendations where appropriate into that section.

We generally have the same recommendations. Most of them have been refined or reworded and they will probably, I am sure, go through more of that. But there seemed to be, again, a general consensus with the underlying issues and concepts as the group has been working with them.

So having said that, there is one other change that we made but I don't want to talk about that until we get to it, which is of course the section where we talked about medical necessity and the decision about when to pay or provide a service, but we will get to that.

And lastly, we have to address this one remaining recommendation that George had included in his memo, and it appears to me that it sits most appropriately in this first section on fair and equitable treatment, so that is where I plan to discuss that.

So with that, I think we can move right into the recommendations, which begin on page 7. And in this section there are three recommendations and they address this new, broad area which we feel is the lead area, the overarching area, which is fair and equitable treatment, safe and effective CAM intervention.

The first recommendation is that the purchasers and other health plan sponsors -- generally, that is the category of purchasers. Then the persons who actually carry out the insurance benefits, the insurance companies and managed care organizations, that they offer packages that include CAM benefits, so without reading it word for word that is the intent there.

There are some edits that I would like to make to that personally because I realize we have had this effort internally, as you all know, to try and make the recommendations shorter, clearer, more concise and to the point. And I am realizing sometimes when we do that we occasionally lose a subtle concept, a nuance that is important. And in this context what needs to be differentiated is the role of the purchaser versus the role of the insurance company. I would like to make the recommendation a little clearer that would clarify that we would like the insurance companies to have benefit packages that include this, that they would offer coverage of CAM benefits in either their basic packages that everyone gets or as an optional supplemental where an individual could choose to buy it.

And if we put somewhat strong language out on that and we then follow that up with the concept that we then recommend that purchasers, such as employers, consider offering this because it is really their choice. But the strength here, in George's viewpoint, is getting the insurance companies. And we did hear from the largest insurance company in the United States that isn't doing much in this area. And what we would be saying is that you need to at least be putting the packages out there and then let people decide. Let the employers decide, let the consumers decide if they want to buy it. So that is where we were coming out.

DR. GORDON: Discussion?

DR. TIAN: I noticed the omission of the "safe and effective CAM interventions." Does that mean the licensed?

MS. MILLER: No. This means that services and products that have undergone some research, clinical and probably health services research too, whereby they meet some threshold of safety and efficacy.

DR. TIAN: Well, if it is possible I can make a suggestion, I think all the CAM services -- let's forget about products -- the services, if they are licensed, that means a general understanding they are safe and effective. If they have already proved by a certain level they are safe and effective, they should be covered.

DR. GORDON: I think that is what it says, "Coverage of safe and effective CAM interventions." I think if we start getting into the realm of licensure we are going to start muddying things up. We are just making a general recommendation here, as opposed to coming down on the side that everything has to be licensed, because then we run into naturopathic physicians are not licensed in this state, massage therapists are not licensed in that, acupuncturists are not licensed in the other.

I shouldn't be talking so much for you, I'm sorry.

MS. MILLER: Well, if I can interject here before it goes too far, we do have a recommendation on licensure in No. 8, that we have tried to keep precisely focused to just coverage and reimbursement, and this whole approach of barrier, how is licensure a barrier to coverage and reimbursement. But we don't get there until No. 8.

DR. TIAN: Okay, until later.

MS. MILLER: Wayne?

DR. JONAS: Where is the term so frequently used by third party groups, "appropriateness"? There is another term that is used that is more than "safe and effective," excuse me.

DR. FINS: Medical necessity.

DR. JONAS: "Medical necessity," sorry. Yes.

MS. MILLER: Well, we actually addressed that in Section 4, on when to provide and how to provide services, but if you all want to discuss any of that now, we can.

DR. JONAS: If this is the up front, overarching recommendation, shouldn't that terminology be placed in here? Because that, for most places, has a very specific definition. Like safety and efficacy, it has a particular set of standards that are used for determining medical necessity.

MS. MILLER: Well, usually when an insurance company builds a benefit into a package, whether it is hospice care or whatever, it automatically includes medical necessity and appropriateness, and they work at a more micro-management level of defining what that is.

To me, it opens a broader question, which we tried to deal with in our previous write-up of the problems we confront with establishing medical necessity and appropriateness criteria for CAM.

Go ahead. Joe seems to be biting at the bullet here.

DR. FINS: One of the problems is that for something to be safe and effective, achieving a CAM-like goal, but sometimes "medical necessity" implies that you are improving. So, like hospice care or physical therapy, if it improves rehabilitation it may meet a medical necessity requirement. However, if it just makes you feel better but it doesn't really lead to an improvement, it may not be medically necessary.

So to get entrapped in that in this context, I think, would really put it --

DR. JONAS: Isn't this recommendation saying that their benefit packages should be offered? Shouldn't that follow the current approaches taken by these groups to determine when they offer them, which includes medical necessity?

DR. FINS: Medical necessity, I think, is often a federal phrase. Each private company could set up the terms and conditions. No, the company could opt to say, we think pain relief is an outcome of physical therapy, not necessarily improved mobility, and so therefore, we can establish that as the criteria to offer the service, or to continue to offer the service.

DR. JONAS: I understand what goes into medical necessity. I'm asking why it's not in here if we are recommending that these become part of benefits packages?

MS. MILLER: Let me give you my own opinion, and I don't hold myself out as a CAM expert. I am not a CAM practitioner. However, I think there is this issue that we are then tying CAM strictly to the current conventional way of practicing, that you have to have a disease or injury first before something can be done.

You would have to look at several of our other recommendations, including the tax one, to know that we believe there should be a shift where this concept of health promotion or maintaining a health status should be included in the overall perspective and philosophy.

So, if we put it in here, we are actually narrowing -- well, let me see.

Joe, you want to start off? You are a member of the group, so I imagine you are going to do some prefacing and then come to this side of the table.

DR. JONAS: Well, I don't see where this has been related to wellness in here. I mean, you just brought up wellness. I mean, I am speaking for Dean here. I like the spirit of what you are saying, but as Dean would say, why are we applying different standards for this than we do in conventional medicine?

DR. FINS: I think there are two issues. There are things that are disease-altering interventions, like Dean's protocol could meet a medical necessity expectation in lieu of, say, bypass surgery.

On the other hand, there are some CAM interventions which will not meet the medical necessity expectation because it is not treating a disease condition. It may be just, not just but it may be promoting wellness.

I think what I would suggest is that this issue gets put into the text somewhere and addressed and maybe we should say that they should use criteria such as medical necessity but not limited to medical necessity.

DR. GORDON: Joe, just for my information, how does this work in terms of hospice care?

DR. FINS: There is a Medicare hospice benefit with established interventions, but if people are, say, terminally ill and dying and they have not enrolled into a hospice and they were getting physical therapy, which maybe helped them with some kind of symptom relief but they weren't actually getting better, it might be hard to prove medical necessity and the benefit could cease. So I want to avoid that pitfall.

DR. JONAS: It is also equally hard to prove that it was safe and effective or has not been proven.

MS. MILLER: Okay. Right. Joe, you had your hand up? And then Veronica, and Julia, did you have a comment? Okay.

MR. PIZZORNO: I totally agree with the same standards approach. Unfortunately, the term "medical necessity" has been extremely effectually used by the insurance companies to eliminate reimbursement of CAM not only to CAM professionals but also to holistic M.D.s. It just, unfortunately in this particular example, Wayne, doesn't work.

MS. MILLER: Okay. Veronica?

DR. JONAS: Between that and "safe and effective." I mean you can use the same thing with "safe and effective" as you can with "medical necessity."

DR. FINS: But "medical necessity" implies a kind of a curative model.

MS. MILLER: Yes, Veronica?

MS. GUTIERREZ: I would like to echo what Joe Pizzorno just said. "Medical necessity" has been used more than any other reason I know of to deny chiropractic care. I have no problem with "clinical necessity." In fact, any contract that I sign for delivery of health care, I always amend it. I scratch out "medical necessity" and I put in "clinical."

I talked to the insurance companies about that, and they just use the phrase because it is the most commonly used phrase, no other reason. It would be very easy for us to change that right now, as we are changing the paradigm for health care or wellness.

So I would like to change "medical necessity" terminology to "clinical necessity."

MS. MILLER: Okay. Tom?

MR. CHAPPELL: Yes, I support the point of view that CAM is not as narrow as the term "medical necessity." I would like to, as I did when the Aetna people were here, use the example of dental hygienists in dental insurance plans. That was not originally a benefit, eligible coverage, but it came back. It ultimately got expanded as a product area, not because it was medically necessary but because it was safe and effective, and a good way to prevent long-term reimbursement that they would eventually have through therapeutic. It was preventative.

So I think this language, "safe and effective," is the right language because there are modalities that are clearly safe and effective but are not medical necessities. I do think we need to protect the paradigm that we are trying to build here, and this language, as it is drafted, does that.

MS. MILLER: I will just throw in here, this will tie directly to the changes in the tax laws that we will be discussing in just a few minutes.


DR. LOW DOG: I don't really like "medical necessity" here, but I think there needs to be something. I am not sure if the word is "appropriate" or not. I think that there needs to be a stronger move towards primary, secondary, and tertiary preventive types of strategies, and that would include even the secondary prevention like screening, for Pap smears for older women, expanding this beyond medical necessity.

Tertiary prevention actually includes a lot of things that CAM does because a lot of patients are at a place where they have plateaued, I think, as somebody said the other day, and they are moving past it. You can use "PT" for rehab or chiropractic, et cetera.

So I think maybe "appropriate." I think there needs to be something in there other than "safe and effective," maybe "appropriate" or "preventive."

DR. GORDON: It is time for some wording, and then let's see if we have consensus. We have had a fair amount of discussion.

DR. FINS: The paradox of this recommendation was, I think, when it was written, we wanted the same standard so CAM practitioners and modalities, and all that, were not discriminated against, but it looks like the way it is written, we might have written it into a dead end, if we link it to "medical necessity."

DR. LOW DOG: Yes. I vote not "medical necessity."

DR. FINS: I guess the rationale is, we didn't want them to have a higher standard to adhere to, was what this recommendation was meant to convey, I think.

Right, Maureen?

MS. MILLER: Right, it was. It was fairness. If you are looking at safe and effective conventional treatments to put into your benefit plan, then you should do the same with CAM. That is all this was trying to say.

Actually, we have already gone through the process of prioritization in this section, where we have started out at the broad, and gone down to more specific. The issue of appropriateness and medical necessity is something done down at the health insurance plan by people farther down.

The green-eye-shade medical directors contribute to this, but they get into specific details of how many visits will we get for what reasons. That is a very narrow process, and this is a 30,000-foot level policy recommendation, where we were trying to go.

DR. LOW DOG: So you think it is appropriate to leave it the way it is?

MS. MILLER: Yes. I think these issues that you are raising are good ones, but what I might say is, maybe they are more appropriate to put that kind of language in once we get down to some of the recommendations a little later on. Thank you.

DR. GORDON: Okay. Can we call for a consensus on the recommendation the way it is written now? Do we have consensus on this? Can we live with this one?


DR. GORDON: Great, thank you. Maureen?

MS. MILLER: Okay, the second one is that -- this long list of people here -- that everyone involved, basically, in the coverage process, that they maintain an expertise regarding CAM, and including CAM experts, on appropriate advisory bodies, working groups related to health benefits and health coverage, reimbursement policies, and any relevant or applicable processes, including coding.

So it is, again, forcing all the people who basically control this process, from the government down to an HMO or insurance company, to open their doors to these discussions and to CAM experts.

Yes, Joe?

DR. FINS: I don't like this phrase, "processes to CAM." Maybe just say, "in health care organizations, make use of CAM expertise in crafting health benefit plans, health coverage reimbursement, and applicable coding."


MR. PIZZORNO: How about insert in front of "process," "advisory process"? Because they do have advisory processes. You are just saying, include CAM people in them.

MS. MILLER: Okay. So instead of on the third and fourth lines of the recommendation, that it would basically read, "which influence health policy and interventions, these organizations open their" -- I'm sorry. Not "open." Where was it? Yes, that's not right.

DR. FINS: "Make use of CAM expertise through advisory bodies," or something, "and internal mechanisms as they craft health benefit plans," et cetera, et cetera, and "devise coding."

DR. LOW DOG: "Which influence health policy and interventions, maintain an expertise regarding CAM." Can't you just leave it the way it is, but just taking out, "open their processes to CAM"? Then you just have "health policy and interventions, such as maintaining an expertise."

DR. GORDON: What is the wording then, Tieraona?

DR. LOW DOG: "The Commission recommends that purchasers and other health plans sponsors, insurance companies, managed care organizations, and health care organizations which influence health policy and interventions, maintain an expertise regarding CAM and include CAM experts on appropriate advisory bodies," blah-blah-blah-blah.


DR. LOW DOG: Is that okay?

DR. GORDON: Okay with everyone?

[No response.]

DR. GORDON: Great.

MS. MILLER: All right. No. 3, "The Commission recommends that professionals working in complementary and alternative health care actively seek out opportunities to advise and participate on public and private bodies that address issues related to health services research for CAM and health care generally, CAM-related demonstration projects, coverage and payment for health services and products, and improvements of coverage-related processes, such as coding." This is the flip side.

And this is in there in part because Don White from HCFA testified that they had opened up their technical advisory group and invited and no one came forward.

DR. GORDON: It seems sort of unexceptionable except somehow what is happening doesn't get out to the people. So the connector between 2 and 3 is how the information about those advisory boards gets out to these folks in the field who may want to participate on them. And I feel there needs to be something in there about that.

MS. MILLER: Well, the federal agencies, the federal purchasers here, CMS, OPM for the Federal Employees Program, VA -- well, I am less sure of VA and DOD -- but they actually publish, in the Federal Register, their invitations. The bigger nut to crack is the private insurance companies, and there, you just really have to lobby yourself.

DR. GORDON: But even with publishing in the Federal Register, not everybody gets the Federal Register, and I think there has to be a little bit more outreach so that, for example, if we know a list of major CAM organizations that they are on the mailing list for these federal organizations when they start to promulgate rules or think about research programs.

MS. MILLER: Your point is correct. In the world of conventional health care and these processes, the people who take care of making sure that their doctors or nurses, or whomever, get on these bodies are the associations, so it is incumbent upon the CAM associations to inform their memberships and to help with that process. Actually, they usually should be the ones sending in the applications and the letters, and what not.

DR. GORDON: But we need those words in there for the government to send out the appropriate information to all of those CAM groups.

MS. MILLER: Well, again, the initial action is on the part of the private party. It takes the association contacting like CMS and saying, "I want to be put on your mailing list." HCFA -- and it is hard to go from HCFA to CMS -- is not going to do the outreach here.

DR. GORDON: Even if we asked them? Because NCCAM, for example, has in recent years begun to do more of that outreach. So, for example, when the strategic plan comes out, there are all these people on the mailing list who get copies of the strategic plan.

MS. MILLER: Well, I'm staff here. I will do anything, put in anything you guys want me to put in, but let me just tell you, if you want this to work, that is all I can say, give you my opinion.

I'm not sure I would count on CMS doing outreach to associations. They do a lot of outreach. They have a whole outreach effort, but it is totally targeted at beneficiaries. I'm just being candid and honest.

SISTER KERR: I think Jim's point, though, what you are getting is information.


SISTER KERR: But we can't get any action, given the two realities. The organizations don't know, and the other bodies don't want to tell them.

So what action is needed? Because I haven't seen anything, for example, through the acupuncture groups. I consulted with a couple people. I don't know that it went out, for example, from HCFA.


MR. PIZZORNO: Perhaps we could ask CAM Central, as we now are calling it, to maintain a list of such opportunities and advise the associations of them.

MS. MILLER: There you go, and we can add language to that effect, and deal with it.

I heard Linnea say, off mic, that we could also discuss this more fully in the text, and that certainly can be done.

So what I am hearing here is, we have this general recommendation, but it has to be revised to include the CAM organizations. Likewise, we, either as a separate recommendation or as part of this one, tie in the proposed CAM Central to take on an outreach effort here to connect the two parties.

DR. WARREN: I like the connection part. I have got a question. Can we take No. 2 and No. 3 and combine them into one recommendation instead of having all this verbiage in there?

MS. MILLER: We did that originally, but it ended up being very long. We also felt that it was more powerful to talk to the insurance companies and HMOs directly, specifically let them have their own recommendation.

Often what happens, having worked in those kinds of situations, is the staff get an assignment to take these reports, go through it, and pull out what recommendations apply to them. This will be very clear that this gets on their list. Again, I think it is a strategic decision.

DR. GORDON: So, do we have a consensus, then, on No. 3, with those additions that Maureen has mentioned, dealing with the text and moving the outreach function over to CAM Central?

[No response.]

DR. GORDON: Great.

MS. MILLER: Before we leave this section, if you all could pull out this one-page piece of paper that you got yesterday, the third page of the George DeVries memo.

If you need a copy, Corinne has extra copies. We have a stack of extra copies. If you don't have a copy, raise your hand.

[Show of hands.]

MS. MILLER: This is actually a concept that came up at the October meeting, which was to look at the tax laws, the Internal Revenue code, the policy of which, though, is directed by the Treasury Department, not the IRS, to look into that and consider a recommendation that would address some of the barriers to coverage of CAM that are currently found in our tax code.

Steve and Corinne and I went down and met with Treasury. They were very open to us. We met with a very senior-level official. George participated in that meeting by phone. The major barrier that we found is that in their regulations is a provision that the services be under the direction, or basically, be referred or ordered by a physician.

That was one, and that is a big one. Then, from there, it goes into the issue of medical necessity.

So we felt, in the time given, that we couldn't go into the regulations, that we would probably need a lawyer to help us to identify specific sections of the regulation that needed amending, and instead we are offering a more general regulation here, that this be taken on by Congress and the Executive Branch.

Let me read it, just so we can then begin our discussion. This recommendation currently reads: "The Commission recommends that the Internal Revenue code should be amended to provide equitable tax treatment of health insurance coverage of various CAM health care services and products.

"Specifically, the Commission recommends that congress hold a hearing and consider legislation on equitable tax treatment and the executive branch consider administrative relief for employers who include coverage for dietary supplements and for CAM health care services and products that have been shown to be safe and beneficial."

Okay, Tieraona?

DR. LOW DOG: Just for clarification, "who include coverage for dietary supplements and for other health care services and products." Why have you --

MS. MILLER: I think it was shared with us the last time. There is a bill that has been introduced that specifically addresses equitable tax treatment for dietary supplements and that is already out there. Then we also get into this issue of the sensitivity of using certain terms and we can't use the words "safe and effective" with regard to dietary supplements, so we need to carve them out and handle that separately because if you do then they become drugs. Otherwise, we have to drop the terms "safe," "beneficial," "effective." We have to drop all that.

PARTICIPANT: How about "safe and wonderful"?



DR. GORDON: Okay. Any other issues on this or do we have consensus?


DR. FINS: What kind of tax relief do employers currently get from -- that was the beginning of the question -- for other kinds of insurance products? So, if an insurer has a drug benefit as part of their insurance package, do they get tax relief for providing the drug benefit?

MS. MILLER: Yes. It is tax deductible to them.

DR. FINS: Okay. So, basically we are putting this in the private sector with giving it parity?

MS. MILLER: Correct.

DR. FINS: Only in the private sector?

MS. MILLER: Well, that is where the tax issue applies.

DR. FINS: Right. So, if a company decides to provide this in a package and employees opt for it is what we are talking about, they will get some kind of tax incentive to do so?

MS. MILLER: Yes. That is the way the system works right now.

To be fair and honest, the concern of the Treasury Department with this, they have two concerns, one of which is that they were very open to this as long as there was evidence that the products and services were safe and effective.

It is hard to know when to use those three little words. Dean wants us to use them all the time, but we have found we can't always use them.

That was their first concern. Their second one was the assessment of the impact on the tax revenues on the budget that we need to support all these other roads and schools and education. We are not addressing that here because it is pretty standard operating procedure, when they consider a bill like this for CBO, to do a cost estimate on it. So that will be taken care of, and if Congress sees it costs too much money, they won't do it.


MS. MILLER: But on the other hand, to balance this out, employers, usually they decide how much they are going to spend per person on premiums. So when CBO looks at this -- and they are already pricing out the Dietary Supplement Law -- what they are looking at, from what I am being told, is that they are looking at, basically, fixed premiums. If they are spending $800 per person, then they are likely to be offering the dietary supplement within the $800, and there won't be premium creep. That is an issue.

A hypothesis that they are considering is, will this cost money. There is no evidence that it will save money yet, but will it be done within the context of current premium levels.

DR. FINS: At the risk of sounding politically incorrect and just raising the possibility of any perceived conflict of interest in this recommendation and whether or not it is self-serving to certain industries and whether or not we want to recommend it in this context.

MR. GROFT: Some would say almost everything that we do has some degree of conflict of interest. But it is our recommendations to the administration and to Congress what we think needs to be done. I think that is what we have been asked to do.

MS. MILLER: It has been reported to us that this is a barrier for employers offering coverage is right now there is this incentive. They can deduct the typical conventional packages. If they want to offer a package of three or four CAM services, they are doing it without any ability to deduct that and have any financial relief.

Joe and then Tieraona.

MR. PIZZORNO: I think this is a great idea and I support it strongly. I think the idea of the "safe and beneficial" is an important part of this because, clearly, we don't want to open this up to everything but those things that are safe and beneficial. I can think of all those men with cardiovascular disease, a third of whom who have significant, offering some B6, folic acid, and B12. I can think of all the pregnant women who this might be just be the thing that will get them to take the folic acid and avoid prenatal defects. It makes a lot of sense to me.

DR. GORDON: I just want to interject a process note. It is 20 of 3 already, and I would like to move through as quickly as possible with only comments that bear immediately on the recommendation and then to make a decision on the recommendation as quickly as possible.

DR. FINS: What criteria will Treasury use to determine whether something has crossed a threshold to say that it is safe and effective?

MS. MILLER: Again, I raised that issue in some conversations over the last few days, and what I am told is that Treasury will not do that and that is the way the current policy works for conventional medicine. What will then happen is it gives the insurance companies and the employers the freedom to design those packages and they decide what is safe and efficacious, which is what happens now on the conventional side.

DR. FINS: No way linked to Medicare determinations?


DR. FINS: Okay.

DR. LOW DOG: I just say I support the recommendation and I don't have any further edits or anything.

DR. GORDON: Can we have consensus on this? Yes? Okay.


DR. GORDON: Can you live with it?

PARTICIPANT: I can live with it.


MS. MILLER: Okay. Joe, we can live with it.

DR. GORDON: Let's move on.

MS. MILLER: Okay. The next section was medical effectiveness, and there are two recommendations in this section and they start on page 10. And the first one is that we recommend that the Secretary of HHS convene a public-private task force to develop a multi-year research plan. And the intent of this is to get all parties, all the stakeholders, all the groups together since there are limited resources, limited budgets, identify what needs to be done, what the actual research issues are, how some of these methodologies are the same or different from but certainly of the scientific quality. Basically, what it is that we need to do in health services research for the next five years to give everyone guidance on this.

Yes, Joe?

DR. FINS: I am just wondering. It just is a semantic question about whether or not this should go into the Research section as a recommendation because it is basic clinical epidemiology and public health research methodologies. And it is certainly in the Access and Delivery theme, but the question is there is a whole side of CAM research that is not basic science or clinical but health services. So I am just wondering as an editorial decision where the next couple go.

MS. MILLER: Right. I think we will work with that.

DR. GORDON: You will work that out?

MS. MILLER: We will work that out.

DR. JONAS: If you do bring it into the Medical Research section you will have to cut it markedly down because we don't do anything that we have to take a breath on.


DR. JONAS: And I do want to point out that we spent a lot of time in the Research section cutting out a lot of these wordy extended things which we are now keeping in these, and I think this is an issue that will need to be addressed. If we are going through and wordsmithing things right now and end up deciding, well, gee, we want the more tight, pithy recommendations later, then a lot of this stuff is going to get cut out anyway. Or, perhaps if you don't want to do that, then we need to go back and look at what we cut out in the Research section to make it more flowery.

We do have a section on health services research, by the way.

DR. FINS: It should be basically in one place or the other.

DR. GORDON: Can we defer this to a discussion between the committees as long as we are clear on the recommendation at this point?


DR. GORDON: So we have consensus on this one?

Okay. Let's move on.

MS. MILLER: Okay. No. 5 in this section is that federal agencies, the states, and private organizations then fund this research as well as demonstrations. And in particular we identify the underserved and vulnerable populations with this regard, the various models of integrative and collaborative CAM, providing CAM services that have been mentioned as just some examples of what would be done, which in the pithy note we could take that out.

PARTICIPANT: Move it to Research.

MS. MILLER: I'm sorry?

PARTICIPANT: This one belongs in Research.

MS. MILLER: Okay. Is there general consensus, though?

DR. WARREN: You have got another part to this, don't you? That is the next recommendation. Looks like it could be included into the same one and then passed off to Research.

MS. MILLER: You mean 4 and 5?

DR. WARREN: The cost and cost effectiveness needs to be all in one in this demonstration project. You don't need two different demonstrations.

MS. MILLER: Right. We have kept them separate to now and I mean I think this will ultimately be like Steve's decision when we were looking at how the report pulls together because these were very critical issues to the Coverage and Reimbursement issue. And the kinds of health services research which we will want to explain more fully in the text the next go-round will get at those kinds of issues, not to say that Gerry Pollen and Wayne aren't interested in these issues.

Gerry is saying another possibility is to just reference them and tie them together if we are going to leave them in separate sections.

DR. FINS: I think that all the health services research should be in the same place and we should have some sort of hierarchy. We recommend health services research to do cost benefit analysis, integration, stuff that was in our last session that is in Wayne's area. We should bring it all together.

MS. MILLER: Right.

DR. JONAS: The intent was to go through the recommendations, get agreement on them, and then reconstruct where we are and where are we going.

DR. GORDON: Okay. So, do we have consensus on No. 6? Yes? Everybody? Okay. No. 6. Health services research and demonstrations.

MS. MILLER: Right.

DR. GORDON: We have got 5, we have got 6.

MS. MILLER: Right.

DR. GORDON: Let's go to 7.

MS. MILLER: And then there is 7, which specifically addresses coding. This is a little different. As we discussed last time, this coding is a complicated area. There are a number of competing interests and political issues here that cannot be resolved during the course of this Commission. So what we were suggesting in this recommendation is that it be done within the Department. It would probably be spearheaded by this CAM Central Office, but to basically pull the right parties together, conduct a study, do a report, and make recommendations on taking care of this.

Can people live with this? Okay.

DR. GORDON: Okay. Good.

MS. MILLER: All right. Then the next section is licensure, and I think we mentioned this earlier in Access. We have kept this here and we have kept it on our agenda specifically as a barrier to coverage and reimbursement, and that is the sum total of our interest in this topic. All other aspects, of course, are in Access and were fully discussed at the prior session.

So, specifically in our mind, the barrier here is really action at the state level, whatever they choose to do and whatever advisory groups or whatever happens. We are not speaking to that but what we are asking here is that as states confront this issue of licensure that they build into it the fact that they are blocking access to CAM services if there is no licensure.

DR. GORDON: The question is whether licensure should be specifically mentioned as a barrier because that doesn't appear in here so it is a little hard to know what we are talking about.

MS. MILLER: At the time we drafted this the language of choice was "legal authority to practice" since that is broader and it covers licensure, registration, the various types of regulation.

DR. GORDON: Then maybe it needs to be made clearer in the text what we are talking about and why. It is hanging out there without more justification.

MS. MILLER: So, is there general consensus?


MS. MILLER: Okay. The next section is where we have dealt with medical necessity and appropriateness. I have to say the last time there didn't seem to be a lot of enthusiasm for that discussion. There wasn't any palpable excitement in the room on that subject. And in our work group discussions what we came back to was, okay, well, in dealing with this micro-level process of who determines whether a service gets paid for, it is covered as a benefit. Say again hospice care, as an example, is covered but when will it be medically acceptable for it to be covered because not just anyone who wants hospice will get it.

And when we looked at CAM and how this is currently working in the outside world, what is being effective, what came out of that was the NIH consensus conferences on acupuncture where there is a federal body, either ARC or NIH, that comes out with some statement about CAM that consolidates all the research literature and provides some guidance to when this is a useful, safe, and efficacious procedure or intervention. And so we opted to switch to that tactic to get your reaction rather than to get into the nitty-gritty of insurance companies and their processes. I think there was some sense that that would be faster than trying to deal with the insurance companies.

Yes, Joe?

DR. FINS: I don't understand. There are two parts to 9, it seems to me. And Part 1 is that all those agencies -- and I think I would add ARC to that list since they would probably expect to be on that list -- to identify CAM interventions of importance to patients, health care providers, and the general public, which is one question. And then the second part of it is where there are areas of disagreement you need consensus statements. I think the first half is important. The second half is a different issue. I mean there are things that are important that people will agree on and there could be things that people find important but there is disagreement or a lack of accord on what the appropriate intervention is.

And also, a consensus statement or consensus panel means something very specific. It is usually in the context, how do we treat hyperparathyroidism and how high does the calcium go before we do the operation, you know what I am saying?


MR. GROFT: Well, I think we said "state of the science conferences" rather than "consensus development conferences."

DR. FINS: It is different in health services. One is sort of a public needs assessment of public impressions and the other is where there are controversies in the science, it seems to me. At least that is how it is to me.

DR. GORDON: I don't see necessarily the controversies part. I mean I don't see it. It is not spelled out there.

DR. FINS: If you are talking about reaching a consensus usually you have a disagreement.

MS. MILLER: I did review the consensus guidelines, actually Wednesday before we came here. There was a broad ranging participation and topics discussed on acupuncture and it was different from the sense that they didn't talk about treating one medical condition but they talked instead about all the research where acupuncture has been proven or not proven to be effective and they laid that all out.

And from what we are told, that has actually been the document that has been driving coverage of acupuncture around the country. That is what they used. They set their coverage guidelines around the NIH consensus conference on acupuncture. We may have heard that in May but I know we have heard it subsequent.

DR. FINS: Maybe you simply want to add coverage consensus statements on issues of coverage and reimbursement.

MS. MILLER: And I am not sure NIH would do that.

DR. JONAS: Yes, I think that is the point, actually, is that this is misplaced, I think. Consensus conferences are used for a variety of reasons, not just single reasons, often to address controversy, as you have mentioned, but also sometimes to get the information out about data that does exist. It is something that is safe and effective and it is not being utilized, then they will have a consensus conference and say that. They aren't necessarily focused on payment, and as you have said, I think it is probably unlikely that the NIH would do that. And there is also no statement in here about payment, so I think if that is the goal of this recommendation it is not hitting what you want to have it do and so it needs to be changed.

DR. GORDON: One possibility is that it be part of Information or Research rather than here in Reimbursement, or else that it be justified as part of Reimbursement. Is that what you are saying, Wayne?

DR. JONAS: Yes. I mean in the Research section we actually have a whole section that deals with doing summaries of the current state of the science and evidence, so this is already dealt with in that. It isn't necessarily targeted towards any application of that but it is often used for that. And even though the consensus conference on acupuncture is being used by some groups to make determinations about payment, that is not what its goal was. And if so, it is not very effective for that because there were only two conditions in which it was stated to be effective and those weren't even the ones that acupuncture is usually used to treat.

MS. MILLER: Yes, Tom?

MR. CHAPPELL: I like this recommendation. I think it helps provide evidence ultimately for the different insurers to reimburse because there is a process, there is agreement, and I think in many, many cases they are looking for some general body of agreement on certain things rather than making an arbitrary decision. So I like the opportunity here that could result in greater and broader agreement on reimbursement.

So I would like to see the recommendation passed with the edit to the last phrase where we say, "conduct conferences to produce consensus statements that lead to reimbursement."


MR. CHAPPELL: "That can lead to reimbursement."

DR. FINS: When we tried to reconstruct how we got to this recommendation in the group -- and I might have missed one of the phone calls but -- there were several tracks that were going into whether or not something could be considered for funding, for reimbursement as an entitlement of some sort. One, was it safe and effective? The second was based on public desire and interest, that they really were clamoring for this thing to be covered. And I think what this was meant to do, at least in an earlier iteration, was establish a mechanism to decide whether or not something might be considered for funding for inclusion in a benefit package. And also, I think the consensus phrase was meant to invoke a priority-setting process, to rank order or something like that, to reach a consensus on what the priorities were.

But I think as it stands right now there are a lot of things that are implicit in here.

DR. GORDON: Do you like the edit?

DR. FINS: I like the first half, like what people find important, which might have been addressed elsewhere. I think the state of the art of the science is addressed in the current knowledge things that were in the Research section. And I think that this was really meant to reach a consensus on whether things should be covered or reimbursed.

DR. GORDON: Let me ask in the interest of time that either we come up with wording now or we ask the committee to reconsider this one -- there are a lot of implications -- and then come back with a recommendation, okay?

MS. MILLER: I am seeing heads shaking for the latter, that we go back as a group and work on this.

DR. GORDON: Okay. Great.

DR. JONAS: I would just suggest you take out NIH so that it doesn't get tagged with that process -- but that also broadens what Health and Human Services can do -- and that you tag it to reimbursement if that is what you want.

DR. GORDON: Great. Thank you.

MS. MILLER: Good suggestions. Thank you.

Okay. The last section that addresses a barrier is supporting coverage and reimbursement through information. And I have to admit this is one place where we are saying we want something more than fair and equitable treatment. We think an extra boost is needed here because payers and providers often just don't have the information or know necessarily where to get it, and the growing body of CAM literature is a bit overwhelming at this point. And I do reiterate "at this point."

So we have four suggestions under this area, the first being that rather than having HHS set up a new website, which is the more general language we had the last time, is that the NCCAM through their clearinghouse mandate that they take this on, providing information specifically that has to do with health services research, with costs and cost effectiveness of health care. And I had discussed this with Corinne that we extend or expand what NCCAM is doing to include some of the research and topic areas that people in payment are interested in.

DR. JONAS: Don't they already do this? I mean they have not excluded research on cost and cost effectiveness in their clearinghouse.

DR. GORDON: Is it there? Corinne, do you know? I had a related question.

DR. JONAS: Would you like them to do a summary of that information? Pull it out of PubMed, for example, and do a summary of it? Because you can find it. Just type in "cost effectiveness, CAM." They are tagged that way. You can find that information. You will find about four studies.

MS. MILLER: Yes. That was my next point, which is, I think we raised it because there is not a lot now, but we are pushing this agenda to build this mass of health services research which will be coming out in future years. It is basically to make sure that it has been in an accessible place.

DR. JONAS: I think if you are talking about producing information out of what is out there, then that is different. I mean then you are asking them, all right, we want you to produce a summary, we want you to collect it in one place, do an evaluation of it, and do a summary of it, or something like that. That might be more useful. Again, I am not sure who should do that. They could do that.


DR. FINS: I don't think they should be limited to just the lay public but professionals also need this information. And I think it fits more cogently in the Information section with all the other dissemination products.

MS. MILLER: Right. Again, that was part of the process when we go through the final report.

DR. GORDON: I agree, Joe, that we may want to change the location, but what about the recommendation itself, Wayne's suggestions, any other thoughts about it?

Wayne, do you want to reword it or do you want it the way it is?

DR. JONAS: Well, again, it depends on what the Commission's goal is. If the goal is to summarize the information on cost and cost effectiveness in CAM so that we can have that information to make decisions, then I think we should ask that specifically. We would like NCCAM to do a summary of current information on cost and cost effectiveness pulled from various resources, not just their information, and make that information available through their clearinghouse. We can say that.

DR. GORDON: I would add to that that they do it on an ongoing basis, that it not just be one summary.

DR. JONAS: Okay. Ongoing summary, updates.

DR. FINS: Is the staffing at NCCAM constituted to be involved in a health services research arena or is it more like clinical science and basic science?

DR. JONAS: They actually have a mandate to do health services research in their appropriations language.

MS. MILLER: Yes. I thought I heard at one time that they really weren't quite up to full readiness on doing health services research, but we can build that up in the text, too, and talk about how to handle this.

So, my sense is there is general consensus but we need some rewording that targets more clearly a specific goal for this information.

DR. GORDON: And I think the question that Joe raised, too, that you are addressing now, Maureen, is, is it appropriate to ask NCCAM to do it or should we ask that it be done? And maybe you can talk with NCCAM and see if they are appropriate.

But would you agree, Wayne, the important thing is for it to be done? Or do you think it is important that it be at NCCAM?

DR. JONAS: I agree. I don't think the particular location matters. I mean a variety of other agencies could also do this.


DR. FINS: And since this is really on the health services research front, I would delete the "safe and effective CAM services and products," which is addressed in other parts of the dissemination model.


DR. GORDON: I'm sorry. I didn't understand that, Joe.

DR. FINS: This is an Access and Delivery information piece, which is not about safe and effective services and products but really health services research and demonstration projects and cost models and cost effectiveness. It is this category of information we are talking about, not whether or not something works, which is covered in other areas of the report.

MS. MILLER: They should include things that have been proven not to work.

Okay. Let's move on to No. 11, that "The Commission recommends that appropriate federal departments report to the President and Congress" -- we should add "periodically" or "every two years," something, "on the status of coverage and reimbursement and impediments to coverage and reimbursement within their respective programs."

This would be CMS for Medicare and Medicaid, the Defense Department, the VA, as well as OPM for the federal employees. And this is in here because having these large agencies on the line to report on this is a way of keeping them moving in this area. They don't like it.

DR. WARREN: Part of this report would be like a trans-departmental force, or what would it be to get this report out every two years?

MS. MILLER: Well, we discussed having one report for everybody but that would be administratively impossible in the federal government so each agency would do their own. And we can make that more clear, Don.


MS. MILLER: General consensus? Sounds like there is. Okay.

12. This is a general recommendation, again to the private sector, that the movers and shakers of health policy as they are sometimes referred to, primarily the various associations and provider organizations out there for the insurance industry, for HMOs, for hospitals, professional groups, practitioner groups, that they basically start talking about CAM at their various annual meetings and policy meetings that they have every year.


DR. FINS: It is not like something we can really effectuate. I think that goes in the text. And I think it goes in the Education section better as part of what professionals need to know or executives need to know.

MS. MILLER: I think it was felt by some of the other work group members of using the Commission as a bully pulpit on this.

DR. GORDON: The question I have here is whether there is anything we want to ask the government to do to help to make this happen.

MS. MILLER: Jim, it is in there. Just wait. The last one is you.

DR. GORDON: Okay. That is good but I want to know if we want to do more than just provide information.

MS. MILLER: Oh, it was meant to be funding to help develop informational programs. I think that is what you had asked for the last time. I'm sorry.


MS. MILLER: If this is a new idea --

DR. GORDON: No, no. That's fine. I did ask for that, and maybe that's enough to do it. The question is, what we can recommend to the government to make sure or to encourage Recommendation 12 to be enacted by the private sector.

MS. MILLER: I can't think of anything myself.

DR. FINS: Can anybody think of anything?

DR. WARREN: It still should be there.

DR. GORDON: What Maureen was saying is that in No. 13 we provide a bit of a carrot in terms of providing money for information. I am asking if there is anything that the government might do to encourage insurance or managed care associations, aside from -- which is kind of dropped out until the end -- the whole issue of Medicare in particular but also Medicaid because one of the issues with Medicare is that if Medicare provides coverage that certainly pushes along the whole process for covered benefits generally.

MS. MILLER: That is true. We have made no recommendation here that Medicare cover anything specifically, and I think it is felt that in this instance it is actually going to be easier and quicker for employers to do stuff than the federal government, particularly with the prescription drug benefit on the line. They are not even acting on that this year.

So oftentimes CMS does serve as the 800-pound gorilla in leading people in coverage, particularly like transplants, but in this case employers are leading the coverage in this field and I think from the experts we have talked to that is likely to continue.

I have gone to some of these annual meetings of the managed care industry and the insurance industry and they have annual policy meetings, they have wide-ranging topics. I am on their mailing list. Never have I seen any of these CAM topics addressed by these industries. I mean, it is just intricate, those chains.

DR. JONAS: You haven't been to the summit meeting that John Weeks puts together?

MS. MILLER: No. You can invite me.

DR. JONAS: Okay.

DR. GORDON: Okay. So then maybe what I am looking for, and I think I talked with you about this specifically, is to specifically mention federal agencies and not just put them in the implementation responsibility, perhaps back under No. 1. I just think we have to somehow even though it is implied to make it clear that we want federal agencies to be covering safe and effective CAM approaches.

DR. JONAS: I agree, and I think if you wanted one recommendation to get the federal government to at least examine which areas might have the potential for reimbursement or coverage under CAM, that you would specifically ask Medicare and Medicaid to do that, because then they would do it using the processes that they normally apply and get it on the radar screen.

DR. GORDON: Would that be another recommendation?

DR. JONAS: I would think that is a separate recommendation.



DR. JONAS: I agree with you that it may be difficult to get them to do it. It won't go as fast as industry. That doesn't necessarily mean it shouldn't be done.

MS. MILLER: The reason why it is more complicated for Medicare to do this than an employer is because they have to change the statute in 1861 about who can provide services. At this point acupuncturists are not listed, massage therapists.

So it is not just a matter of coverage for them, it is a matter of also then going through this separate process within this big federal agency of deciding who can provide the services.

DR. GORDON: Understanding the complexity, I think there is still a desire to make that recommendation.

MS. MILLER: Okay, you all want that. Can you give me the language, then?

DR. JONAS: At least catch them up with the Flexnor report.

MS. MILLER: Can we have some language here?

Ming, then Linnea.

DR. TIAN: Well, first, I second with Wayne. I think it is very important that we recommend, and Medicare and Medicaid, also the ground policy, to consider to cover CAM services provided by licensed practitioners, both physicians and non-physicians.

I think this point has repeated in the past one year and a lot of the non-physicians of acupuncturists and the other CAM practitioners mention this, that we are not included yet.

DR. GORDON: I think that point is covered now under No. 1. Wayne's is in addition.

I think you were saying something in addition, Wayne. Do you want to repeat it?

DR. JONAS: Well, I think we should recommend that Medicare and Medicaid specifically evaluate what CAM therapies look like they may have potential for reimbursement and we might throw in there identifying what issues need to be addressed in order to move that forward.

DR. TIAN: Medicare and Medicaid should be another issue, just one recommendation separate to government policy, if I may suggest.

DR. GORDON: We have two things on the floor. We have Recommendation No. 12, then we have a new recommendation. Maybe we should address Recommendation 12 and 13 and then go to the new recommendation.

Is that okay, Wayne?

DR. JONAS: That is fine. I had just one other item about Recommendation 12. Joe mentioned that under Recommendation 10 we should take out "safe and effective" because we want them to address all the CAM, not just those.

I think the same thing would apply for No. 12, "insurance, managed care integrate information regarding CAM interventions," not just about safe and effective but also ineffective ones.


DR. GORDON: We are on No. 12. Anything else on No. 12?

DR. JONAS: As Dean on No. 12, I have to say I disagree with removing "safe and effective."


MS. MILLER: If you didn't do that, I was going to do it for you. You have to talk to Dean on that one.

Okay, Joe?

DR. FINS: We have had this conversation in the past, and I think what we decided, and I think, which is partly why Recommendation No. 1 read the way it did, was that whatever standards were in existence to make something eligible for Medicare coverage should also exist for CAM. It shouldn't be a higher standard or a lower standard.

It was in the context of that deliberative process. If it was safe and effective, it should be funded, not because it was CAM, because there was something that was effective and safe, or not. I don't want us to get into the position where we are funding CAM preferentially over other things.

I think it is especially important to be wary about, say, funding a supplement before you have a Medicare drug benefit. I think that is illogical.

DR. GORDON: Yes. I think that is understood for No. 1. I think the issue for No. 12 is somewhat different, and I tend to agree with Wayne more than with Dean, because --


DR. GORDON: The issue here is, people should have information about things if they don't work as well as if they do work.

DR. FINS: Right. Absolutely.

MS. MILLER: Right.

DR. GORDON: And so, if we just have "safe and effective," then we are limiting the range of information and we are not performing this as we should.

DR. FINS: Right.

DR. JONAS: But that doesn't apply to No. 13, however. "Safe and effective" should remain in No. 13.

DR. GORDON: Do we have a consensus on No. 12 if we strike "safe and effective"?



MS. MILLER: Okay. And then 13 is basically asking the Secretary of HHS to support the development of information programs on safe and effective CAM treatments, or interventions which can then be targeted to purchasers.

I assume this would -- I am not assuming, I am stating this would include CMS for Medicare and Medicaid, as well as insurers and managed care organizations, a wide range group, professionals, providers, the whole gamut.

DR. FINS: But Nos. 12 and 13, I am just wondering. I agree with Wayne's point, and this side of the table, about taking out "safe and effective," but does that convey that we also want adverse event information to be conveyed?

DR. GORDON: I think the same should be there in 13.

DR. FINS: Right.

DR. GORDON: Because the issue is just giving them information.

DR. FINS: Maybe in the Information section -- is Corinne still here? Corinne, yes. Do they have any journalists-in-residence program from the trade publications? Do they have programs like that where they have visiting journalists at any of the institutes?

I am wondering if that could be something that would help get the word out into the various trade publications, and we could have journalists in NCCAM just to help with information flow as a fellowship, or something like that.

Is this an idea that you have kicked around?


DR. GORDON: Do we have a consensus on No. 13, then, as amended? Wayne, do you want to state the other recommendation, so we can have discussion on it?

DR. JONAS: I didn't write it out. Just give me a minute.

DR. GORDON: Maureen, anything else we need to go back on? We are okay at this point?

MS. MILLER: Yes. While Wayne is thinking, the intention was that all federal programs were included because they are purchasers in No. 1. We can either take an approach that splits them out separately and gives them a special charge, and then have another recommendation that targets everyone else. But the intent was to not let anybody out.

DR. GORDON: Yes. I would single them out. Again, I think it is an area where we should make a specific statement because we are representing the people, who are, in turn, speaking to their government.

DR. TIAN: I agree with that. I support James's idea.

DR. JONAS: I think the wording is fine in No. 1 but, again, I think it should be split out and specified, requested that they do this.

MS. MILLER: So, am I hearing that instead of putting Wayne on notice here on draft language, that the group will take this back and split this No. 1 into two, 1(a) and 1(b), one that specifically targets federal programs?

DR. GORDON: Yes. Wayne, do you have the recommendation?

MS. MILLER: Oh, I think I was letting him off the hook.

DR. JONAS: Yes, she let me off the hook.

DR. GORDON: All right. We are going to make it sounded like a different kind of recommendation. No. 1 really relates to safe and effective. You were making a recommendation that Medicare and Medicaid should evaluate CAM to see whether -- I was thinking you were extending the reach of that.

DR. JONAS: Well, you could do it either way. I mean you could say, are there established CAM therapies that now meet our current standards for reimbursement? Let's look at the entire field and make a decision on that.

One could add to that, or request in a report like that, that we also make explicit what criteria are needed in complementary medicine. If we assume that they are going to use the same standards that they use for conventional, then that may end up being redundant, but if we think there are some unique characteristics and would like them to look at that, then that could be added to it.

DR. GORDON: That is still slightly different from No. 1.


DR. GORDON: Therefore, it constitutes another recommendation, if you are going to make it.

DR. JONAS: Yes, if you were to extend it and also ask for an examination of the criteria for reimbursement in the area of complementary and alternative medicine, then that would be an additional item.

DR. GORDON: Part of what we were, I think, talking about was that we needed to demonstrate for demonstration projects the safety and efficacy of various things. We should not be here thinking about creating a whole new entitlement class, but we want the process to be evaluated and the evidence to be generated. Then it will go into the same mix.

I mean, the private sector can do whatever they want, they can establish a benefit package that includes this or not, but a federal entitlement would be under the rubric of Medicare or Medicaid, and that has profound implications.

DR. GORDON: This is a somewhat different point that Wayne's recommendation is making. It is talking about a process of evaluation, which is somewhat different than covering safe and effective, to the effect that the evaluation presumably has already been done.

DR. JONAS: I mean, it is essentially like what we have asked in the research field, that methodologies be explored. We begin to look at research methodologies separate from just looking at particular topics, using standard methodologies.

It is essentially saying, please look at your methodologies in relationship to some of the unique characteristics, or special characteristics, of complementary and alternative medicine, and provide guidelines in terms of what is needed in order to provide benefits in these areas.

MS. MILLER: Included in the text will be a description of the current Medicare process and some discussion about how that might be fairly and equitably extended to safe and effective CAM services. If that tracks with what you are thinking about, Wayne.

DR. JONAS: Well, I assume that if they look at the area of complementary and alternative medicine, they will use the process that they have established. So that is for looking at things now.

I think what Jim is highlighting is that, if we want them to look at the methodology in relationship to some of the unique characteristics of CAM, that we could ask them to do that also. Those are separate items, although they could be bundled. I mean, you could request them separately. They could be done together. I think probably there is not a whole lot of information about cost and effectiveness, and reimbursement issues and CAM.

DR. GORDON: So I would like to get a fix on where we are. Do we want to make a recommendation at this point, or do we want to send it back to the group to generate the appropriate wording?

Where are you with this, Wayne? Or Joe?

DR. JONAS: I think Maureen has the spirit of what we are talking about.

MS. LARSON: I would like to recommend that we put it back to the group and put it inside the text, that specific information that you were just talking about with respect to the procedures and protocols for Medicare. Then the group can consider the wording of a recommendation for looking at the methods, the text.

DR. JONAS: I mean, one of the issues that keeps coming up in this is, how do you get things that are valued, that deal with wellness, for example, and health promotion that are very difficult to research, identify, et cetera, et cetera, but we still want them in some way, what process should be done to address, to enhance those, to bring them more up front.

So, if that is what we would like, then we could particularly ask them to do that. Let's look at your process in relationship to these kinds of aspects of CAM, and say, is what we are doing adequate for that. If not, what suggestions or modifications are there?

DR. GORDON: It sounds like what we have agreed to do is to refer this back to the group, as Linnea was suggesting, to address the issue that Wayne is raising, rather than try to come to consensus on wording right now. Is that correct?

So, can we do that, and then include others in that discussion who are interested in the topic? Great.

Thank you very much, Maureen. It was great.


DR. GORDON: So the next section will be on the proposal for a central office for CAM Central, and Don Warren will take us.

Discussion Session VIII: Coordinating

and Centralizing Federal CAM

DR. WARREN: Thanks for warming up that seat for me, Maureen. We are adjourned.


DR. WARREN: I want to say that last time, that was the first time we had ever reached a consensus vote of 100 percent, and what we were in consensus about was a draft recommendation to create an office at the highest level, a CAM office.

Let me read it: "The Commission recommends that the president, Secretary of the Department of Health and Human Services, or Congress, should create an office at the highest possible and most appropriate level, with sufficient staff and budget to perform the functions that include but are not limited to coordination of federal CAM activities, federal CAM policy liaison with conventional health care and CAM professional organizations and institutions in commercial ventures, planning and convening conferences, workshops, necessary advisor groups, centralized CAM media point of contact, and facilitation of implementation" -- that is what happens when a Southerner tries to talk fast -- "of the White House Commission on recommendations."

The reason you got all the background information when you came, is because, basically, the duties of this office, the fleshing out of the duties of this office, depends on what each one of your committees came up with, and it is still in the making. It is not completed yet.

So all the things that we agreed on in this meeting the last two days, that have the possibility of being included in CAM Central, for lack of a better word, they will be included in it.

At the last meeting, we were asked to develop functions for the office. I believe that each one of your committees has developed those functions for the office. We have five overlying proposed responsibility areas that each one of these recommendations that you come up with will be utilized into. Let me just go through those, right quick.

No. 1 was the "coordination of federal CAM activities." And what we are looking at is establishing a trans-departmental committee of all the federal agencies that are interested or have any play in CAM and getting their input. If we can't get the input of all these federal agencies, then they are going to fight us tooth and nail, so we are looking to incorporate their activities into this.

"Conduct a baseline survey," and how many times this week have we talked about surveys? Survey of this, survey of that. Conduct a baseline survey of CAM activities in the federal sector and report it. How many times were we given a time frame to make a report? I like that.

"Provide expert advice and consultation to the Secretary on CAM." We would expect that the Secretary of DHHS would call in the head of this CAM office and consult with them.

No. 2: "Federal CAM policy liaison with conventional health care and CAM professional organizations, educational institutions, and commercial ventures. Planning and convening workshops and conferences." We had many recommendations about that. Being a federal media point of contact. That is that 800 number that Corinne was talking about. They call in, it is not a give-all-the-information thing, it directs callers exactly where to go.

"Facilitation and implementation of the recommendations," and I think this is by far the most important part of the whole operation right here is if we can't get our recommendations implemented they are fodder for the trash can.

Anybody have any comments? Fire away.

SISTER KERR: I just want to clarify that -- Charlotte -- from what you said, is it true that all the recommendations that would come out of this Commission would fall under this to be implemented? And it is not just certain ones that, well, obviously, were inappropriate for this oversight?

DR. WARREN: Let me make sure I understand you. You are saying that all of the recommendations that come out of our commission fall into this office responsibility of implementing them?


DR. WARREN: No, no.


DR. WARREN: All they are trying to do is work it through the system, facilitate it, get it moving, and have somebody there to prod the system.

SISTER KERR: To facilitate the recommendations?

DR. WARREN: Facilitate the recommendations.

SISTER KERR: That is what I meant. I'm sorry.

DR. WARREN: Not actually implement them.

SISTER KERR: Right. Sorry.

DR. WARREN: Just to make all the different systems work.

SISTER KERR: Thank you.

DR. WARREN: Linnea?

MS. LARSON: Just going through all the recommendations, this office is not charged with the implementation of all the recommendations. And usually, if you look at the recommendations it indicates who and what is the activity.

DR. WARREN: That is right.


DR. FINS: Related to that question, though, how do we ensure that this person in this office, which is in HHS, has any kind of -- I am going to propose a suggestion, that maybe having interdepartmental personnel on loan. So in other words, if the FTC was doing something, there was a way of borrowing people. So, when we talk about the staffing we also talk about sufficient interdepartmental or whatever, different cabinet departments so they could be shared, which would give you a real person on the ground in the other department to help coordinate things. So, it could be outside of HHS but they would be answering to this director or whatever this person is going to be called.

DR. WARREN: It depends on where the office is located as to whether or not you can borrow staff from other agencies. If this is an office that oversees all the various departments of government that are related to CAM, then I think you could borrow.

DR. FINS: It leads to the issue of the president implicitly, and that is what I was getting at. So I think we could perhaps say that it would have the opportunity to have interdepartmental borrowing as it were without actually saying that it should be at that level. But it would say that if that is the functionality that is where it had to go.

DR. WARREN: Good idea.


SISTER KERR: This is like looking for nitty-bitty -- it is not really nitty-bitty if it really became a problem, but say, for example, the recommendation that I was focused on yesterday about the demo project at the VA? Now, say the VA read that recommendation, this report comes out and it is accepted, and they pick it right up and say, right, we are doing it. Now, and then we have a centralized office whose job is to facilitate that recommendation. Is there a potential conflict there of, like, they have got to then go back to this CAM Central and talk to them or can they just go ahead with the recommendation?

DR. WARREN: I think when you start implementing the recommendation then all CAM Central does is just keep an eye on things. I don't think they have to go back and particularly party with you, do they?

DR. GORDON: Charlotte, maybe part of what you are talking about needs to be addressed a little bit more in the text as we describe the texture of the office and of how it might interact.

DR. WARREN: That is my intention. The text of our committee is really probably going to be close to the last thing being written because of all the various committees that are having to put their stuff together. Then we have to take that as a compilation, come up with a written text, you all will get a copy of that, and that way for CAM Central it will be more of an overview of our recommendations.


MR. PIZZORNO: Two things. First off, it appears that the advisory board has been left off of this. I still think we need to have the advisory board and specify that it include CAM, conventional, public health, and public representation.

DR. KACZMARCZYK: Joe, I beg to differ with you because in No. 3 where it says, "planning and convening conferences, workshops, and necessary advisory groups." It is on page 2, Line No. 30." When Donald was racing through he did not mention "necessary advisory groups."

MR. PIZZORNO: I saw that, but this is an advisory board for this office specifically.

DR. KACZMARCZYK: And it is the broad categories.

DR. WARREN: On No. 3.

DR. GORDON: I think the issue that Joe P. is referring to is that originally when we formulated this CAM Central Office, the overall advisory board was a very central aspect of that formulation.

DR. KACZMARCZYK: That is in the text and that text is in limbo as Don described because if you look at the process that we have discussed, it is going to be one of the last documents written. It is going to be probably be right there when the executive summary is being written.

DR. GORDON: Joe just wants to make sure it hasn't disappeared.

MR. PIZZORNO: I just wanted to make sure it hasn't disappeared, that is all.

DR. KACZMARCZYK: It will be there in some form in the text when it is written at a much later stage.

DR. WARREN: And I think what you are describing is the public advisory group we were talking about being in actual control.

MR. PIZZORNO: I am not sure about control or what, but it is an important part of it.

DR. WARREN: But it has a large overview of the situation.

DR. GORDON: So, I think what Joe is looking for confirmation of is that essentially as that was formulated by this group that is continuing, Don?

DR. WARREN: It is going to be continued.

MR. PIZZORNO: Now, the second thing is, and I think this is just restating what you just said, when we look at the proposed activities all these have to be changed since we just changed all of it in the process.

DR. WARREN: Effie?

DR. CHOW: No. 3, page 2, "planning and convening conferences, workshops," we should be facilitating planning as well, not we just do the planning and encourage others to encourage and facilitate other associations.

And the other thing is that we are going to implement our recommendations here. What about futuristic kind of thing? And if this is an ongoing central coordinating office, then I would think there would be some updating or projection of future activities. Do you understand what I am talking about?

DR. WARREN: I am trying to follow that. Are you talking about --

DR. CHOW: This advisory group is --

DR. WARREN: The futuristic part of it, are you looking at what the advisory groups would do?

DR. CHOW: Well, rather than just implementing our recommendations, five years from now where is it going to be? Is it going to be reviewing the present status of situations and making further recommendations?

DR. WARREN: Effie, I believe we are going to be covering that in the text of the document where we explain what happens in successive years. We hope that this is a permanent program. We will try.

DR. GORDON: I think, though, that Effie is asking that -- and I think this is the same question as that came up with Joe -- that as that text gets worked out it needs to come back to the group as a whole.

DR. WARREN: Absolutely.

DR. GORDON: I think that what Effie is talking about is the proactive functions of that office, as well, and that it is not just reviewing what is going on but that it takes certain stands. So, that is the information that we will be looking for.

DR. WARREN: Right.

MR. CHAPPELL: And I think some of the ongoing visioning will come out in the visioning section because I see there is an opportunity there to talk about some futuristic mechanisms.


MR. PIZZORNO: Also, as we develop the language for this office further, the issue of budgetary authority I think needs to be addressed, too. I am concerned about their ability to not only facilitate this, but maybe there would be some situation where they need to do some funding of some activities, also.

DR. GORDON: Joe, I'm sorry. Just to clarify, you are suggesting what, a specific amount of budget, or what are you suggesting?

MR. PIZZORNO: I don't understand how these things work. But I do know that if you don't have a budgetary authority it really limits what you can do. So let's make sure we in our thinking process ensure that that is covered.

MR. GROFT: Yes, Joe. They all will be incorporated into this, and your activities are dictated by your responsibilities that you identify when you write up the responsibilities of the office. It just carries forward.

I think you have your outside advisory group, you have your trans-agency advisory group, the activities flow. I think what has been given here is certainly enough to last another four to five years, at least.

DR. WARREN: What about the budget, how does that work?

MR. GROFT: The budget, that is another process. It is totally independent. That comes through, that an office works up and you get an idea. Here is how much we think we need, here are the responsibilities of the office, what it normally costs. For example, most new offices, they talk about five people staffing an office, a million dollars a year, or two million dollars a year for responsibilities, and then you have to justify how you spent your money and what you are going to spend it on. Then it is up to you and your supporters to gather additional support for an increase of budget to justify other activities.

So it is a growth area. It is what has happened with Office of Alternative Medicine, and perhaps is what is happening currently with the Office of Cancer Complementary and Alternative Medicine. It depends on the activities and the desire to see an office grow.


SISTER KERR: I think I needed to hear the rationale again as to why we have not made a statement of opinion of where it should be under DHHS. Why didn't we say and what is the probability of it -- not that we are suggesting that would happen -- but that it would end up in some obscure place and not perhaps have the teeth we need?

DR. WARREN: What we are really looking at is getting the office established by the President first -- that would be our first line -- Secretary of Health and Human Services, or then, Congress. Any of those offices can establish this. Preferably, the fastest way you are going to be able to do it is with the Office of the President, and that would be wonderful.

There are a variety of mechanisms for doing this through the Office of the President. One is, he just creates an office, just like he created this Commission.

Another is, he could do what is called OPIC, where you have half-governmental, half-public representation on a governing board. That is another way of doing it. Then it goes down to Department of DHHS.

There are a lot of ways of getting it done, but that seemed to be the best way, is to put it in and say, we are going to get this handled at the highest possible level we can.


DR. FINS: I have two points, and I want to resurrect Joe Pizzorno's comment about the advisory body. As I read this, it looks like advisory groups, it is like having a conference or workshop. It is not as central to the constitution of the office, and so I really think we are establishing an office with the appropriate staff with an advisory body to do the various things. I think it was part of the conception and I think it will help balance it.

The other thing is that I really would like a little clarification on your thinking about the relationship of this office to NCCAM. And one is a research entity, but I think it is important that we spend a little time thinking about that relationship: Is it hierarchal; is it on parallel tracks; et cetera.

Have you guys thought about that?

DR. WARREN: NCCAM is basically associated with research. That is their basic premise. There is a huge pie out there called CAM, and research makes up a nice percentage of it, but it is by no means all of it. I think that this office will take up a lot of the slack that NCCAM can't fulfill at this point.

The NCCAM has a clearinghouse. They will still have their clearinghouse. People will call into CAM Central, and we may be referred to the clearinghouse.

DR. FINS: I would just want to maintain the independent scientific peer review dimension about funding. I mean, this office might determine, to some extent, what kind of funding in the aggregate goes to NCCAM, but I wouldn't want this office to make decisions about what kind of research gets funded, other than establishing the appropriation, perhaps, to NCCAM. I think it has to be based on merit and scientific, the normal NIH review process.

DR. WARREN: I understand that.


DR. JONAS: It doesn't look like there is any danger of that since the entire Research section was left out of it.


DR. JONAS: So, I am wondering, was that an oversight?

DR. KACZMARCZYK: It was quite intentional, Wayne.

DR. JONAS: By design? Well, maybe we should discuss that element.


DR. JONAS: And can you explain that?

DR. KACZMARCZYK: It was omitted by design because this would focus on non-research aspects of CAM.

DR. JONAS: Okay. I think that we have got a problem there because the Commission has explicitly addressed research and has a number of recommendations about research and we have discussed the relationship between the Commission's recommendations, the various other agencies that are non-NIH-based that need facilitation and need to have research done, and the collaboration and cooperation with NCCAM and OCAM and the other institutes about that that still require some kind of HHS coordination and oversight.

DR. FINS: This is where the director of NCCAM would be logically one of the folks who would sit on the advisory body. But I think that if we don't spell out our conception of the relationship, it could be perceived as threatening. I mean there should be a tremendously good alliance between those two entities. But I think we need to prevent confusion by being more explicit about that relationship.

DR. JONAS: I also think that we can put in recommendations but we need to word them properly so that it is clear that the goal of CAM Central is to work collaboratively with other entities to facilitate and coordinate the research process. I think it is very easy to do that. I think leaving them out, like you said, makes it even more complicated.

DR. GORDON: But what I am hearing you say, there are two pieces here. One is that the research piece needs to be back in, number one. Number two, more generally, this has been coming up. What we need is -- and I think it is time to do it now -- is to do the description of the function and the structure of this office. We made virtually all the recommendations that we are going to make. And I think what I am hearing from a number of people from a number of different perspectives is we want all of that fleshed out. We want the advisory committee back, we want the sense of how the office is going to relate, and that the next step would be for us to look at that and then have a dialogue with you about that.

DR. WARREN: I believe the "fleshing out" as we call it will occur now as soon as this 10-day period is up where get the recommendations out. And once we get them back, then we can flesh this thing out completely.

DR. FINS: We know the categories of recommendations. We know what the kind of functionalities will be that will be required to do that. I think it is probably reasonable to get a sense of what the structure of that office is going to be in the same time frame as the 10 days.

DR. KACZMARCZYK: That structure, Joe, so depends upon where it is located.

DR. FINS: For us to decide where it goes? Or is that presumptuous?

DR. KACZMARCZYK: I think it is rather presumptuous.

DR. GORDON: I think that there are certain elements that we made clear and we may or may not make a recommendation about where it should be located. But it has been pretty clear from the discussion that there are certain functions and certain kinds of relationships and certain kinds of structures, for example, the advisory committee that we want the office to have.

DR. KACZMARCZYK: That is in the briefing book for the October 4th through 6th.

DR. GORDON: I understand. I am saying what people are looking for is to see that again and to see how it all connects up.

DR. KACZMARCZYK: And because it was presented previously, we did not reprise it for this meeting.

DR. GORDON: Understood.

DR. KACZMARCZYK: Steve has a point.

MR. GROFT: Yes. It is time to construct this section as a section, no longer just as a group of recommendations but it is to give everyone an idea of the responsibilities, functions, activities. I think that is something we can start and have done.

DR. GORDON: What do you see as, then, the time frame?

MR. GROFT: I think the same time frame, yes.

DR. GORDON: Okay. The same time frame meaning 10 days?



MR. GROFT: I don't view it as a long section.

DR. GORDON: I think the issue that is still out there which several people mentioned is do we want to leave it at the highest level or do we want to make a specific recommendation? It sounds like some people are maybe wanting to revisit that question, Don. I don't know.

DR. WARREN: Well, I thought about that and wondered if you wanted to put all your eggs in one basket and shoot for one level. You could do that, but by leaving the proposal the way it is with the president, Secretary of DHHS, and Congress, and you pretty well leave the door open for any of those three to pick up the ball and run with it.

SISTER KERR: Doesn't the office of the president -- wouldn't it potentially go after the administration changes?

DR. WARREN: That is always a possibility.

SISTER KERR: And Congress is only going to appropriate monies and make offices.

MR. GROFT: I think after a determination has been made how you create the office, whether it is created administratively or legislatively, and that is why of everything you like a legislative mandate because then to undo it you need another legislative mandate to undo it. It is not our decision. And I think we are just saying one of the three groups can create this and whoever will do it and whoever would make that decision.

DR. WARREN: We covered all this in October and we came up with a consensus, and I think we did it and I am so proud of this group for doing it.

Yes, Tom?

MR. CHAPPELL: But information. Is there an equivalent to this with conventional medicine in the government?

DR. WARREN: I don't know that answer.

MR. GROFT: I would say the Office of Research on Minority Health or the Office of Women's Health and the Office of Minority Health, both down at the department level. And there are probably one or two others at the White House. AIDS Policy. So you have a thread then working the whole way down through the other departments and agencies throughout, even like the Office of Surgeon General, another possible location.


DR. WARREN: Effie?

DR. CHOW: We were appointed or our commission was set up by executive order by the president and it was one of the few commissions that are actually appointed by the president, I understand. It would behoove us to keep it at the highest level and not delegate it down to low levels.

MR. GROFT: But see, that is not our decision, though.

DR. CHOW: No, I know.

MR. GROFT: All we can do is state where we think it could go and someone else has to make the decision.

DR. CHOW: But Steve, I am not disagreeing. I am saying I agree with this comment here. I just want to point out that we were appointed at the highest level and we should strive to maintain at the highest level.

DR. WARREN: Effie, if you go back to October, that information is in our handouts then about where the possibilities of the thing being placed, and that clarifies it.

DR. FINS: I think the way to make that argument is to talk about all the various functionalities, personnel needs, and interrelationships and then to meet those objectives. It will be pretty clear at what level, whether through a congressional or an executive directive or whatever, we will have to go.

DR. WARREN: I believe that we are going to be able to flesh this thing out completely. If you get your questions to you and back to the committee before the eight-day mark, then we can have two days to put it together before the 10-day mark.

DR. GORDON: Don, I didn't understand the last thing you said. What are you looking for? I think a lot of the questions have come today. What else are you looking for?

DR. WARREN: Well, there are going to be some modifications, and once the modifications are in then we will finish fleshing out. We are going to do a lot of work on it between now and then and we will get it to you. But the final details will only occur after all the changes have occurred or been brought in.

DR. GORDON: Okay. Anything else, or are we coming to a close? Let me summarize and then we are going to come to a closing.

Session VIII Summary

What I am hearing, strongly, is, yes, we continue to have a consensus for CAM Central; yes, the five general areas that have been described, the areas and what the commissioners are looking for, is a more detailed description, a good deal of which was there in the October briefing book, but a detailed description of the advisory council, of the functions of this office, of the relationships to other offices within the government; and that we have a recommendation that it be at the highest level; that if we want to make it more specific, which it sounds like we don't -- we have not decided to make it more specific -- if we did, it would come out of that entire description of the office.

So we could conceivably revisit the question if it became -- Joe, are you with me on this? I want to make sure you are here -- if it became obvious that all the functions that you just described dictated a particular level, we might suggest that as a preferred level.

So that is where we are, but at this point, what we are suggesting is simply that it be at the highest level.

Wayne, go ahead.

DR. JONAS: And that the research recommendations be also --

DR. GORDON: Thank you. Thank you. And that the research recommendations be folded back in, and that all the specific recommendations be made in accord with the wording that has come out of this meeting. Okay?

DR. WARREN: Thank you.

DR. GORDON: Okay. Thank you all very much.

Let's take a five-minute break. I want to say to our guests here, some of you who weren't here early this morning, that Don Warren will be chairing the last part of the session, that because of security considerations and plane rescheduling, I have to leave and go to the West Coast, but I will make a commitment to reading all of the material that has been submitted.

So take a five-minute break. We will come back at 4:00 with the first panel of public presentations.

I want to thank everybody. Really, we have done a great job. It has been terrific.


DR. GORDON: And I want to thank everybody for really moving to the highest level in dealing with these recommendations.


Public Comment Session

MS. CHANG: Would the following five people please come up to the speakers' table: Boyd Landry; Candace Campbell; Fabrizio Mancini; Jerry Hardee; Matthew Irwin.

Just as a reminder, you will each have three minutes to make your oral statement, and then after you all five are done speaking, we will go to a quick Q&A. Thank you.

DR. WARREN: I would like to apologize to our panelists. A lot of our commissioners had flights they had to catch. Because of security reasons they are gone a little early, but we have to be out of here by 5:00. They close the room.

Mr. Landry. Boyd Landry is here, and he is with the Coalition for Natural Health.

Would you like to start off, please?

MR. LANDRY: Well, I have got a plane to catch, too, but I am still here.

Anyway, thanks for allowing me to speak again. This has been the sixth or seventh time that I have been fortunate enough to be allowed to speak.

I want to start with a overreaching theme, I guess to borrow a term that has sort of surfaced here in this meeting. Instead of creating mechanisms and systems which would allow CAM to grow, you have recommended mechanisms and systems that place CAM in the same failing health care system that we have today. A lot of the recommendations that have come forth over these last two days place CAM into this failing health care system that we have today.

In addition, it doesn't -- this microphone is not very good. In addition, the recommendations do not clearly balance the needs of practitioners who want to be protected but not regulated with the false notion that access is predicated by regulation. If regulation was the key to access this phenomenon would have never occurred.

With respect to Education, usage of terms and phrases like "accredited" and "appropriately trained" designate Big Brother as the determinant of how these terms are met.

With respect to Access and Delivery, these recommendations are more concerned with delivery rather than access. In addition, there is a lack of respect for the Minnesota Law that is working effectively to date. Furthermore, the most important recommendation in this section should be the epidemiological surveys to determine use and patterns of uses as well as which certain practices should be regulated.

On to Coverage and Reimbursement. One of the principal tenets of holistic care is for the patient to have complete and full responsibility for their own health care decisions. As long as there are insurance companies paying and controlling services patients do not have complete and full responsibility. When people dig out of their own pockets cash, the responsibility is greater. Finally, when you get out into the real world at the state level, consumers are not beating down doors to get certain types of practitioners regulated or licensed. Additionally, there isn't a significant number of cases of verifiable harm to warrant state intervention, which is what states look at first before they ever talk about regulation of professions and businesses and occupations, excuse me.

And finally, I want to leave you with one final thought, and this was a quote in 1977 in the "UCLA Law Review." You might see how it pertains today.

"By creating a professional monopoly, licensing contributes to both the doctor shortage and the resulting inflated prices. A leading economist argues" -- this is very short -- "that medical licensing has in addition diminished the quality of medical practice by reducing the number of physicians, the number of hours physicians can devote to their important tasks, the incentive for research and development, and the ability of individuals to collect from physicians for malpractice. Analysis by this expert and others suggests that any savings resulting from the inhibition of quackery by licensing are often offset by costs created by the licensing itself." Thank you.

DR. WARREN: Thank you very much.

Candace Campbell, Association for Health Freedom.

MS. CAMPBELL: I am here today on behalf of the Integrated Health care Consortium, which is a multi-stakeholder group that was formed for one purpose, and that was to organize the national policy dialogue to advance integrated health care.

This was a summit-style working meeting held in the fall of this year, and the goal of the meeting was to identify common ground among diverse groups of health care stakeholders who are already involved at some level in providing, creating, or funding integrated health care.

Nearly 60 individuals participated by invitation, each one representing a segment of integrated health care and each one a leader in their respective fields. Together we represented providers, educators, researchers, payers, and consumers who have a commitment to safely and effectively advance integrated health care. We believe it was a landmark event representing the first time that such a diverse section of the industry met to discuss public policy and identify common ground.

I am happy to report that the meeting was a tremendous success. Not only did it offer people an invaluable opportunity to meet players they wouldn't ordinarily meet, it gave us all a chance to discover that the others didn't have horns. Despite some negative past experiences, distrust, concern about coaptation, and a host of other potential roadblocks to productive dialogue, we were delighted to find a high degree of common ground, and I think we managed to get way past the baggage that has prevented us from working together in the past. In fact, numerous new relationships were established and ad hoc groups were formed to undertake several of the key tasks identified in the process.

I would like to call your attention to just several of those goals that kept coming up in our discussions because they represent areas of consensus that you may want to factor into your decision-making. We have prepared a preliminary report detailing these goals and others, and we expect to have a final report ready in January, which we would be happy to share with all of you.

One idea that really caught fire was the creation of a federal office that would be responsible for coordinating the switch to an integrated health care system. It would also help realign the focus of health care from disease treatment to health promotion and disease prevention. Support for this idea cut across all practitioner types and ideologies and we believe represents a strong desire to move public policy towards prevention.

This idea has been floated in several iterations over the past few years. We want to stress that the version of a federal office we support focuses on the creation of an integrated system, not on promoting CAM. The term "CAM" is, we hope, a short-lived one that will eventually be outmoded by integration.

As an aside, I should mention that to us integration does not mean sublimation but rather working together so that each modality retains and contributes to health care its own genius.

A second recommendation generated through our work was the creation of an agency that would act a clearinghouse for defining the qualifications and scope of practice for all health care providers.

Is that my three minutes? Okay.

I will just tell you quickly the third recommendation was that Congress and federal agencies responsible for health care research should significantly increase their allocations for health promotion and disease prevention, examining the role of CAM and integrated approach in these areas. Thank you.

DR. WARREN: Thank you, Ms. Campbell.

Dr. Fabrizio Mancini, President of Parker Chiropractic College.

DR. MANCINI: Thank you so much for this opportunity, and I want to commend you on all your efforts of this Commission.

I am here primarily to talk about two points, and the first one is the idea of the chiropractors being primary care providers. I would like to start by referring to the ACC paradigm, the Association of Chiropractic Colleges, which is a document that you have already been exposed to but a document that also has been embraced by all the leadership in chiropractic, which states that the purpose of chiropractic is to optimize health. The principle is that the body's innate recuperative powers are affected by and integrated through the nervous system and then the practice which is to establish a diagnosis, facilitate neurological and biomechanical integrity through appropriate chiropractic case management, and to promote health.

I entered the chiropractic field primarily because of this premise, of a premise that believes that the body is a self-regulating and self-healing mechanism. I believe most of us in this room will agree with that, and it is the one thing that I believe was causing all of us to look for a better health care system for our people in the United States.

I have also included in the packet a catalogue and a video because I believe that we need to recognize how high of a caliber the chiropractic occupation has evolved over the last 106 years. And through the catalogue you will be able to recognize specifically our course curriculum and how diverse our curriculum is in order to support the position of primary care provider for chiropractors. Right now, the CCE, one of our accrediting bodies, has raised the minimum requirements for entering chiropractic to 90 hours, which means that we are attracting a much higher level of academic prospective student.

Also, I would like to mention just a point on Title No. 7 under Student Loan Forgiveness for MUAs and to support that effort. And just to give you an example, in our school we have over 700 students. And I sent an e-mail and just asked the students randomly, and I said, "How many of you will be interested in supporting an underserved area if the government is able to help you and forgive some of your loans?" And within 24 hours we received over 50 e-mails saying that they would like to, and I have submitted that to the Commission. That also states all the areas that they have been willing to serve.

My point in this is to be able to just mention to you that right now other portal-of-entry professions such as medicine and osteopathy are part of that system, and I believe chiropractors should be part of that, too.

And in closing, I have also enclosed just a brief summary of some of the research to support the position of primary care provider and also the joint research that we are doing also with the medical community in order to continue to advance chiropractic research and the efficacy that we have through chiropractic care. Thank you so much for your time.

DR. WARREN: Thank you.

Dr. Jerry Hardee, Sherman College of Straight Chiropractic.

DR. HARDEE: Commissioners, thank you so much for allowing this dialogue regarding loan forgiveness for chiropractic students. Much of what I have to say will echo most of a remark by Dr. Mancini.

The chiropractic profession is based on the premise that it exists to nurture and advance a simple and powerful idea. We recognize that the body possesses the inborn capacity and striving to maintain itself in a state of optimum health. All of our activities concentrate on exploring, evaluating, and advancing the concept that the body is a self-regulating system that continuously adapts to its ever-changing internal and external environments to ensure its survival and health.

The nervous system is the communication network that directs this self-healing and self-maintaining capacity and is the focus of the straight chiropractic profession.

Sherman College educates its students and the community that the human body is an intelligent, functioning system that interacts dynamically with its environment by constantly adapting to internal and external changes. We understand that the body is best able to carry out that adaptation when there is no interference to the channels of communication that share information between the brain and all the organs and systems of the body. The dedicated men and women who choose to serve humanity as doctors of chiropractic have been educated at world-class levels to take this message to communities where they will establish their practices and improve the quality of the lives of the people they serve.

Today we ask that you honor their commitment and celebrate their outstanding achievements and anticipated contributions to our society by offering them the opportunity to enter the profession knowing that they will have a chance to serve their communities in lieu of full loan repayment. In other words, loan forgiveness. With the 16 chiropractic colleges across the country graduating several thousand doctors of chiropractic each year whose educational debt load is substantial, we would very much appreciate your intentional effort to allow them to begin the professional phase of their lives less burdened by loan repayment in return for their professional services.

I submit to you today a petition from Sherman College with over 100 names of students who have agreed that if given the opportunity in some form of loan forgiveness they would be willing to serve in MUA areas.

I ask that you today consider the heavy load that they have when they graduate, knowing full well that for up to 10 years many of them will be repaying loans. Thank you for joining with our academic community in recognizing a need for these students to have this opportunity.

And I have saved a few minutes just to say that with what I have gone through to get here today since 4 a.m. this morning, I plead with you to take this opportunity to discern seriously the burden that these students face when they graduate. They deserve the opportunity to have some form of loan forgiveness. Thank you.

DR. WARREN: Thank you very much, Dr. Hardee.

Dr. Matthew Irwin, Group for Scientific Reappraisal of HIV/AIDS.

DR. IRWIN: Thanks. Before I start in on my topic, just listening to these people it has made me think about things and what you guys are trying to do, which is to integrate holistic, alternative medicine into the framework that we have. And it reminds me that the framework that we have relies on having a lot of sick people. It is sort of antithetical to the idea of health promotion.

I have an uncle who was a CEO of a large hospital in Los Angeles for about 30 years and he, knowing my interest in holistic medicine, one time said to me, the main agenda on my table every day was empty hospital beds that had to be filled.

I don't know how that integration would work, but it is food for thought that somehow people are successful with health promotion and how do they do that within this system which really rewards you for having as many sick people around as possible. At least rewards you financially.

My topic that I came to talk about is HIV and AIDS. I have actually come to see that as the defining issue that pits the host versus the germ theory, going back, Pasteur and the debates that he had with people. Because AIDS came along as that you might have a healthy host but it really doesn't matter because HIV is so powerful and so strong and so devastating. And I have actually come to see that personally I don't believe that that is true.

I have known people who have been HIV-positive and healthy for 16, 17, 18 years, and I encouraged one of them to get retested because I don't trust the test very much. He tested negative. Another friend of mine has tested positive and then negative and now positive again. She tends to test positive when she is pregnant.

And I think what it comes to is I am not really asking to do anything except to consider that you might actually look into some of these things. I have a friend who is HIV-positive who asked me to come here today because he has read some of my articles. That is really the only reason I am here. It happens that he is the son of a nationally known chiropractor who is, I think, the head of a large national chiropractic organization.

But I also brought a little article which represents what I think could happen and would be a fertile area for research. It is from the "Times of India" about a small town in India, or maybe it is a city. I don't really know. I haven't researched this to see how accurate it is. Basically, it is a group of counsellors which counsel HIV-positive people in India in Mumbai, which is, quote, the AIDS capital of India.

There are two groups that they interviewed for this article, Salvation Army and Counselling and Allied Services. They basically say that according to their 10 years of experience there is strong evidence to show that the damage caused to the immune system can be reversed. This happens when people change their habits of substance abuse, eat nutritious food, involve themselves in community service, practice discipline and hygiene, receive counseling, family, and social support. Such persons emerge stronger and healthy.

They go on to say that in the 10 years of their program, they have taken care of and attended to over 900 patients, only 15 of whom have died, and they died of malnutrition and tuberculosis.

So what I say to you is, when you hear things about people who are saying crazy things about HIV -- Peter Duesberg is the famous dissident -- I actually think it is worth reading what he has written, but he is only one of several hundred M.D.s and/or Ph.D.s who have signed statements calling for reappraisal of this issue. I see it as a central battleground between the host-versus-the-germ issue.

DR. WARREN: Thank you very much.

Do the commissioners have any questions for our panel? Joe?

MR. PIZZORNO: This is to the chiropractic doctors here. One of the key challenges we have been having is how to go about doing loan forgiveness programs that include CAM practitioners. And one of the key elements has been the ability to provide care in collaboration with the conventional medical doctor versus ability to provide care independently without a medical doctor being there.

If we are looking at an underserved area where there is no medical doctor available, at what level are your graduates able to provide services?

DR. HARDEE: I think there are two or three ways. The first, and I think the most important, is to help people prepare themselves to maintain good health. In other words, to me one of the greatest ways to help people health-wise is to help them eat better, show them how to prepare themselves better such that they can prevent many of the things that simply would not happen if they take better care of themselves.

We are doing a lot of it now. Our students are doing quite a bit of that now, going into communities and talking to people about how they ought to make sure that they are free of subluxations, make sure that they have good diets, make sure that they do the things that they ought to do in order to not have those physical problems that get to the point that they are not able to help them with.

DR. MANCINI: I think that you will find today in chiropractic that there are many practitioners right now, chiropractors working alongside with medical doctors in integrated practices. That has become a very popular way of practicing.

We have in our school -- in fact, this incoming class -- four medical doctors registered, and two Ph.D.s. And they all are amazed at the preparation of the chiropractic education, and that is what I find that you will find in our curriculum, the basis of chiropractic education that gives them a very strong support in providing the adequate care whenever there is not a medical practitioner around.

At the same time, the chiropractors are very much aware of the limitations as far as their scope of practices, and as you look within the states, it varies. We have a few states that are very limited in their scope, and you have some states that are very broad in their scope. I think that as long as our students and our graduates understand the primary purpose of the chiropractor is the overall well-being of the patient and the preparation that we are giving them as a foundation, that they are very well prepared to handle that.


MR. CHAPPELL: Thank you all for being here today. I wanted to ask Ms. Campbell --

DR. WARREN: Speak into your mic, Tom.

MR. CHAPPELL: I wanted to ask Ms. Campbell about the consortium and whether or not there is a sense that you may evolve into a trade association. Have you had any such discussions or visions?

MS. CAMPBELL: No. When we organized this, we said specifically our goal was not to become another organization. We have started an umbrella group that is a national policy working group, and that is what we are looking at as a vehicle to implement the recommendations that come out of our meeting. So that, everybody maintains their own autonomy. We don't have to compete for funding, but it is a way to coordinate the activities.

DR. WARREN: Effie?

DR. CHOW: Yes. Also, thank you very much, all, and nice to see you.

Ms. Campbell, I have read your partial document, the reports, and I am interested in your future Fuller document on that. You know that one of our recommendations is to establish a CAM Central Coordinating Center. Do you see your group working closely at hand, should that office be instituted?

MS. CAMPBELL: Absolutely.

DR. CHOW: And how?

MS. CAMPBELL: I think of all the things that we discussed. That was probably the first and foremost, to get consensus. Everyone agreed that that was necessary, to have some kind of coordination at the federal level.

Our conversation did evolve, however, from a CAM office, which is where we started the conversation, into something that was more about promoting an integrated health care system because we were a little afraid of institutionalizing CAM, which means we maintain an allopathic existing system and just keep adding CAM. It is always other than, and we didn't want to promote that. I think if you call it a CAM Office, you institutionalize it, and forever, then, you are stuck with that model.

DR. CHOW: Thanks for that input.

DR. WARREN: Boyd Landry, I appreciate your observations and your being here through all this time. Sometimes your head-nodding kind of gets to me, but that's okay.

Ms. Campbell, I want to thank you for providing all the information from your meeting to us that supports us. We really appreciate that.

Dr. Mancini, I am going to see him again next week. My son graduates from Parker Chiropractic next week. I also know how the financial aspect of getting out of chiropractic school because I have got that burden at this point. My third son is now accepted into your school, so it looks like I have double the burden.

Good luck with getting reimbursement for an underprivileged area, because when I got out of dental school, that is the way I paid off my loans, moving to an underprivileged area.

Dr. Hardee, thank you for your comments.

Dr. Irwin, I too have seen HIV-positive tests turn to HIV-negative tests through complementary alternatives. Thank you for your input.

Any questions, other than that?

[No response.]

DR. WARREN: Thank you all very much.


MS. CHANG: Thank you. If the following five speakers would come up to the table: Dr. Ginette Hemley; Mr. Ian Cyrus; Dr. William Rutenberg; Dr. Remy Coeytaux -- I apologize if I mispronounced that name -- and finally, Mr. John Borneman.

Again, to remind you, you have three minutes to make an oral statement. After you all have finished speaking we will ask a few questions. Thank you.

DR. WARREN: I would like to start with Ginette Hemley, Ph.D., of World Wildlife Fund.

Yes, ma'am?

DR. HEMLEY: Thank you. It is a pleasure to have this opportunity to address the Commission, and to offer an environmental perspective on complementary and alternative medicine policy, perhaps a slightly different slant from the issues you have been dealing with today.

World Wildlife Fund is actively involved in conserving threatened and endangered wildlife and wildlife habitats around the world with programs in over 100 countries. Our interest in CAM, and in particular, in traditional Chinese medicine, stems from the use of animal and plant derivatives in the manufacture of these medicines, some of which are from species that are increasingly scarce in the wild.

The perceived medicinal benefit of tiger bone, rhino horn, deer musk, bear gall bladder, and other derivatives of endangered and protected species, continues to drive a demand that generally exceeds supply, despite being prohibited or regulated in most countries.

We actively support efforts around the world to curtail poaching and illegal trade of wildlife through a number of ways. We have spearheaded efforts in both North America and East Asia, particularly in China, to build alliances with traditional Chinese medicine specialists and practitioners, with the aim of developing and promoting alternatives to endangered species products through close collaboration with institutions such as the American College of Traditional Chinese Medicine in San Francisco, and with China's State Administration for Traditional Chinese Medicine. We have undertaken a variety of educational efforts to raise awareness about these problems.

Conservation policy is turning, increasingly, to market-based incentives, and this approach is particularly promising, we believe, for the traditional medicine industry in China and other countries, including the United States.

It is our hope that manufacturers and traders will recognize the potential for greater market penetration and profit if they offer products that meet basic content standards, and certify that they are free from adulterants and derivatives of endangered animals and plants.

We believe there are several areas of potential common interest between the Commission and the World Wildlife Fund, and in fact, the conservation community as a whole.

Your concern that biological and botanical derivatives of CAM be clearly labeled matches our concern that packages certify the absence of derivatives from endangered species.

Your focus on research to ensure the safety and efficacy of alternative medicine complements our interest in developing alternatives to medicines that rely on endangered animals or plants.

Finally, your interest in the quality of licensure of practitioners mirrors our concern that licensing requirements include training in the use of alternatives to medicinal derivatives of endangered species.

We would welcome your consideration of the following three recommendations for possible inclusion in the Commission report.

First, we recommend that standards be established and certification procedures developed to assure consumers that medicines do not contain heavy metals or other adulterants, or any endangered animals or plants. This recommendation could be integrated with the Commission's recommendation that biological and botanical derivatives be clearly labeled to enable consumers to determine the contents of medicinal products.

Second, we recommend that research include exploration of natural alternatives to traditional medicines that currently rely on derivatives from endangered species. And we support the Commission recommendation that research be expanded to assure the efficacy and safety of CAM and believe that our recommendation could be incorporated here.

Then finally, we recommend that licensing procedures for CAM practitioners include a requirement that licensees demonstrate an understanding of alternatives to medicinal products that are derived from species that are endangered or protected by certain international treaties or laws, and believe that this recommendation could be incorporated into that, related to credentials.

Just to conclude, we believe that these recommendations could enhance the level of public acceptance of CAM and would also at the same time contribute to national and international conservation goals and interests. Thank you very much.

DR. WARREN: Thank you, Ms. Hemley.

Ian Anthony Cyrus, M.S., American Association of Oriental Medicine.

MR. CYRUS: Thank you, Commissioners, for allowing me to address the Commission.

My name is Ian Cyrus. I am a professional practitioner of acupuncture and oriental medicine, and the newly elected president of the American Association of Oriental Medicine.

Oriental medicine evolved into a systematic approach of triage and treatment through thousands of years of practice in both urban and rural settings throughout Southeast Asia. Through this evolution, oriental medicine developed into an ideal entry point for the provision of general health care services.

OM practitioners can provide basic assessment and diagnostic services, acupuncture, herbal medicine, and manual therapy treatments, as well as make appropriate referrals and promote the continuity of care for each patient.

Our profession is recommending that the Commission encourage policies that will promote continued growth and development of OM in this country. Specifically, we support high entry level standards of training, such as the four-year, full-time professional doctorate program currently under development with strong core components in the biomedical clinical sciences.

We support health care policies that will allow direct access to OM professionals in private clinics, hospitals, and integrated settings. In particular, we strongly support a change in federal policies to allow Medicare and federal employees' insurance to provide reimbursement for OM services provided by OM practitioners.

We support the adoption of new treatment codes that will allow for proper tracking and reimbursement of OM services that are currently lumped under two codes.

Further, we support the use of OM professionals to oversee and conduct research into the best OM practices.

On a personal note, I find myself in a unique practice setting, which, I believe the Commission would find interesting. I practice alongside four very fine physicians at Thomas Jefferson University Hospital Center for Integrative Medicine, Philadelphia, Pennsylvania.

My clinic epitomizes an emerging model of medical practice in which allopathic, homeopathic, and holistic medicine seamlessly complement one another to fulfill the changing needs and expectations of the health-conscious American public. In this setting, I am allowed to practice the full scope of OM without fear of criticism or being relegated to an inferior position in the clinical setting.

Currently, I participate as an equal partner in the clinical setting, research projects, and peer-related education of other health care professionals within the hospital community. Our hospital would welcome a visit by the commissioners, if you are interested.

We would like to be assured that oriental medicine is formally recognized and addressed as a whole medicine by the Commission, and not simply divided arbitrarily into its modalities of delivery. We argued this point among ourselves years ago and we determined that the best moniker for a complete medicine is the use of the term "oriental medicine."

While based in traditional Chinese medicine, it has become a broad and diverse practice throughout Southeast Asia, and the term "oriental medicine" is pervasive in our field. It does not refer to ethnicity, but rather to a unique culture, history, and philosophy.

Finally, the Commission is encouraged to view OM as an effective system of medicine that can potentially lower the cost of basic health care and allow our thinly stretched health care system to serve more Americans, and to serve them better. Thank you.

DR. WARREN: Thank you very much, Mr. Cyrus.

Dr. Rutenberg, American Academy of Medical Acupuncture.

DR. RUTENBERG: The American Academy of Medical Acupuncture is committed to making medical acupuncture safe, effective, and accessible to an informed public. Medical acupuncture is an important complement to traditional physician practice. Precedents have been established that --

DR. WARREN: Turn off one mic on the table, please. There you go.

DR. RUTENBERG: It is in the purview of the Medical Specialty Society to determine the course of study and clinical expertise for its members to achieve proficiency. Credence for this is found in hospitals privileging physicians to practice acupuncture and in state laws granting physicians the right to practice acupuncture under the scope of their license.

The AAMA's 2000 members residing in all 50 states are dedicated to creating a uniform voice among acupuncture providers immune to interprofessional politics and special interest groups. Our goals include education of physicians, peers, and the general public.

To this end, we publish the Journal of Medical Acupuncture and the Acu-Briefs website, respond to local meetings in a national annual symposium, but more importantly, as people trust their physician to be the primary source for health care information, Western physicians will open the door to CAM therapies for most of America. Physician practice of medical acupuncture will increase access to holistic coordinated medical care.

The health and safety of the public must be ensured. Recently published outcome measures document that only 43 adverse events in over 34,000 acupuncture treatments by physicians, and none were considered serious.

Congruent with health and safety is appropriate training. Based on the 1999 World Health Organization Guidelines on Basic Training and Safety in Acupuncture, one criterion for full membership in the AAMA is the completion of a minimum of 220 hours of formal medical acupuncture training in a program that meets AAMA standards. These guidelines are endorsed by the World Federation of Acupuncture and Moxibustion Societies, and have become the international standard.

Last year, the British Medical Association Board of Science and Education published its recommendations calling for a core curriculum for practitioners, including aspects of anatomy and physiology, research methodology, acupuncture techniques, fundamentals of orthodox diagnosis, and ethics.

Graduates of American colleges of medicine and osteopathic medicine whose training in acupuncture meets the AAMA standard have more than satisfied this core curriculum.

Furthermore, every three years members must complete 50 hours of approved continuing education. Diplomats of the American Board of Medical Acupuncture must have an additional 100 hours of formal training, a minimum of 500 patient treatments, and pass the ABAMA examination.

The BMA/BSE stated there are a variety of ways in which acupuncture can be taught and practiced. A certain amount of diversity is healthy. The Information Age has created new models of remote education applicable to selected aspects of medical acupuncture training. The demand and need for evidence-based medicine is inescapable.

Physicians trained in medical acupuncture presenting and publishing research based on sound scientific principles and national medical meetings and in peer review journals are making believers of Western-trained physicians.

It is my hope that the Commission will adopt a philosophy that neither rejects conventional medicine nor accepts alternative medicine uncritically and recognizes that good medicine should be based in good science, inquiry-driven, and open to new paradigms.

Endorsement of medical acupuncture by this Commission will create a cadre of physicians who will bring acupuncture, and by association CAM, into our medical centers, into our medical school curricula, and to our patients. Thank you very much.

DR. WARREN: Thank you very much, Dr. Rutenberg.

Dr. Coeytaux, How do you pronounce your name?

DR. COEYTAUX: "Remy Co-ee-toe."

DR. WARREN: "Co-ee-toe"?

DR. COEYTAUX: Michele got it just right.

DR. WARREN: Medical Acupuncture Research Foundation.

DR. COEYTAUX: Thank you.

Hello. I represent the Medical Acupuncture Research Foundation, and my goal today is simply to highlight the potential role that non-profit organizations may play to help the Commission achieve its objections.

I have read most of the transcripts of your previous meetings and I was particularly interested in the statements from Drs. Leon Rosenberg and Steven Strauss regarding what the NIH can and cannot do to promote and support CAM research.

I believe that professional organizations and foundations can supplement the efforts of federal agencies by fostering innovation at the grassroots level. Successful foundations usually know the needs of their people that they serve, they can respond quickly to new challenges, they can identify the right people to address those challenges, and they can provide appropriate albeit limited resources.

In the case of research, foundations can help investigators develop research ideas and gather preliminary data to help them obtain funding from, say, the NIH. I have submitted to the Commission a one-page document. It describes some initiatives that may be used as examples of contributions that can be made by the not-for-profit sector.

I would like to highlight the Acu-Briefs project, which is sponsored both by the American Academy of Medical Acupuncture and our foundation, currently. We are actually affiliated with the AAMA. This Acu-Briefs project is a website that features an extensive bibliography of acupuncture research. This project could be replicated for other healing modalities.

You may also be interested in a symposium that we are organizing in collaboration with the Society for Acupuncture Research to bring together CAM and Western medical leaders.

In sum, I support the Commission's fourth and fifth recommendations that were stated in the November 16th draft that recommend collaborative support by non-profit sectors and encourages the creation of novel funding partnerships to augment federal agencies.

I encourage you to place a high priority on these recommendations. If followed and supported with sufficient resources, they will help the Commission achieve its objectives not only related to CAM research but also to many of the major issue areas that the Commission is addressing.

I would like to add that, although my perspective on this matter is influenced by my role as a board member for a CAM-related foundation, I also speak as a CAM researcher. I am a family physician, and I will soon complete my dissertation in epidemiology based on my research on clinical trials of acupuncture and the control groups that can be used in those trials. I am also the principal investigator of two research grants that are currently under review at NCCAM.

I am sincerely grateful to those of you in this room who have made it possible for young researchers like myself to choose and to forge an academic career like the one that I am pursuing. I would like to thank you very much.

DR. WARREN: Thank you.

John Borneman, National Center for Homeopathy.

MR. BORNEMAN: Good afternoon. The National Center for Homeopathy would like to thank you all very much for allowing us to speak this afternoon.

I think there might be some notoriety in going last. I don't know that.

As the Commission nears the end of its work, the National Center for Homeopathy would like to take the opportunity to offer some perspectives on the role that homeopathic medicines may play in the future of American public health.

As you are aware from previous presentations, homeopathy is a system of medicine that has been actively practiced for nearly 200 years and in the United States, whose medicines are regulated by the Food and Drug Administration. Homeopathic medicines have been used to successfully treat both acute and chronic illness, including both epidemic and infectious disease for decades.

A growing consumer demand for homeopathic medicines has made their availability nearly universal in the United States, and yet there has been little done to create an effective partnership with the government to improve the state of homeopathic research, disseminate technically correct information about homeopathic medicines to medical professionals and consumers, to promote education in medical institutions, and to integrate the useful aspects of homeopathic medicine into the American public health model.

For these reasons the National Center for Homeopathy recommends to the Commission the following steps: improve communication between government and the existing institutions in the homeopathic community, including the American Institute of Homeopathy and the Homeopathic Pharmacopedic Convention of the United States.

Second, create partnerships between government and homeopathic researchers interested in mechanism of action, basic science, and most importantly, infectious disease research. These partnerships could be as simple as adding homeopathic arms to protocols under existing study.

Third, facilitate the integration of existing homeopathic interest infrastructure including the American Institute of Homeopathy and the National Center for Homeopathy in the health care delivery system in order that homeopathy's useful elements can be employed to the country's benefit in time of national crises. These benefits may include the use of homeopathic care in trauma, post-traumatic stress disorder, and infectious disease.

And finally, increase the public awareness of homeopathy, including what it can and it cannot do.

While these recommendations may seem simple, it is the view of the National Center for Homeopathy that homeopathy is an underutilized resource in American health care. It is our opinion that with proper partnerships with government, potentially with a higher level office, aspects of homeopathy can be used more efficiently to substantively benefit the American public health.

For the Commission's benefit, appended to my written comments are a 1907 report discussing the successful use of homeopathic treatment for a smallpox outbreak in Iowa, and additionally, comments made before Representative Burton's Committee on Government Reform, on November the 14th of this year. Thank you.

DR. WARREN: Thank you very much.

Commission members, do you have any questions for our panel?

[No response.]

DR. WARREN: Well, I have got some. Might as well. I am the chair now, right? Okay.

Dr. Hemley, I appreciate your concerns for the species. I am a hunter and I use everything that I harvest. I was in Africa this year. The black rhino is a beautiful animal. For $30,000 trophy fee you can dart a black rhino, get your picture made with it, and let it go. I think that is absurd because there is always a danger of losing one of those beautiful animals and there are not very many of them in the world. I appreciate them.

I don't know. I was editorializing? Okay.

For our acupuncturists on the panel, we have heard a lot of testimony from different groups of acupuncture, and it just baffles me. When are we going to hear one voice from all the acupuncture positions so that we can then include it into funding? It seems like we have five separate voices that need five separate insurance codings to get five different types of payments for the same procedure. When are you going to sit down at the same table and communicate with each other? This is getting a little bit absurd.


MR. CYRUS: I agree with you. We are in agreement on that fact. As a matter of fact, October of this year the five organizations that you mentioned met and decided to form a steering committee to investigate the feasibility of creating a structure to provide that united voice.

DR. WARREN: You just made my day.

MR. CYRUS: You have made mine, too.

DR. RUTENBERG: Could I add to that?


DR. RUTENBERG: The American Academy of Medical Acupuncture, despite the fact that David Maloney testified here that they were going to have an open-door policy, was not invited to attend and join in that coalition to form a steering committee, and we were disheartened by that and would be more than excited to be invited to join the next meeting.

DR. WARREN: Go ahead.

DR. COEYTAUX: A challenge.

DR. WARREN: I love it.

DR. COEYTAUX: Lay down the gloves.

DR. WARREN: I love it.

DR. COEYTAUX: On another front, I will give an example of what I see happening more and more often in the research world. Those studies that I mentioned that are under review right now at the NCCAM both involve -- I myself was trained through Joe Helm's course, a medical acupuncturist.

All the actual acupuncture treatments will be designed and performed by licensed acupuncturists, so the treatments themselves are more traditional Chinese medicine and yet it shows an example of collaboration in the research world, all of which occurs at the University of North Carolina with very good collaboration. This is not one, but there are many other examples of this type of collaboration.

DR. WARREN: I am so pleased to hear this. I have worried about this since I first heard the five groups talk together, and it has really bothered me -- the same with the chiropractic world -- why we couldn't get all the organizations to come together and bury the hatchet and come up with one voice so we can get this thing moving. I love it.

Dr. Borneman. One more, Effie, and I will quit.

Is there a homeopathic substitute for vaccinations available at this time or will there ever be, do you think?

MR. BORNEMAN: We will deal with at this time right now. The answer is no. There is no evidence in the literature that homeopathic medicines can be used in lieu of vaccination. That doesn't mean that people haven't tried it, but there is nothing in the literature that indicates that.

Further, the Food and Drug Administration has a specific policy that discusses the use of homeopathic medicines for vaccination and in fact proscribes that. There has been significant dialogue between the Homeopathic Pharmacopedic Convention and the Food and Drug Administration on the issue, and there is general agreement in the community that homeopathic medicines cannot be used for vaccination purposes.

If you think about what homeopathy is, it is treatment of symptoms. So the reality is that homeopathy would be best implemented after an outbreak, for example, of an infectious disease to treat those infectious diseases.

What is in the literature is tantalizing. I can't recommend that it be used right now, but the research needs to be done and the research probably would be inexpensive if added to other arms of studies.

DR. WARREN: Thank you.

Effie, do you have something?

DR. CHOW: Thank you all for being here. I appreciated hearing from Dr. Hemley about the wildlife, because we haven't had that subject up, and at the last meeting. This is our last meeting. I am glad this was part of it because I think that is a very important area.

I certainly am glad to hear what you folks said about the acupuncturists coming together, and we do, we look at the person from a holistic standpoint so we must practice holistically.

So, on a personal level and as a commissioner, we have had the concerns and so if we can help in any way, please feel that we are right there for you.

Congratulations on your new position.

MR. CYRUS: Thank you.

DR. CHOW: And thank you very much.

DR. WARREN: Any other commissioners?

[No response.]

DR. WARREN: Thank you all very much. I enjoyed these panels today. Thank you.


DR. WARREN: Ladies and gentlemen, we stand adjourned. See you in February.

[Whereupon, at 4:52 p.m., the meeting was adjourned.]

+ + +

This is to certify that the attached proceedings
BEFORE: White House Commission on Complementary and Alternative Medicine
HELD: December 6-7, 2001
were held as herein appears and that this is the official
transcript thereof for the file of the Department or Commission.

SONIA GONZALEZ, Court Reporter

Meeting Home Participants Thursday, December 6th, 2001 Contents Morning Session Afternoon Session Friday, December 7th, 2001 Contents Morning Session Afternoon Session