[Moment of silence observed.]

          DR. GORDON:  Let's begin.  Good morning, everybody.  Congressman Pallone, who was going to be here this morning, will likely be here later on today.

          So we are going to begin.  We will move right into the continuation of the section on Education and Training.  They were scheduled to have, how much time, 15?

          MS. CHANG:  Fifteen minutes.

          DR. GORDON:  So we will give them 30 minutes, and take 15 of my minutes of the summation.  So we will begin with 30 minutes, then we will do a summation of that, and then we will be moving on to Access and Delivery.

          George and Joe, Joe.

          Session IV: Education and Training

       of Health Care Practitioners (continued)

          DR. GORDON:  Are we satisfied that we are okay with the traditional healing, which is where we ended up?  Do you feel you have a good sense, or do we need to go back over any of that before you continue?

          DR. BERNIER:  I think we came to a good closure on it.  It is a very difficult problem, clearly.

          DR. GORDON:  Okay, we will come back to that when I do the summation and see where we are.  Let's move ahead, then.

          DR. PIZZORNO:  What we are going to try to do is to finish the last of the recommendations, and then if we have time, to go back to the other recommendations, because as a result of several conversations, and George and I working together, we believe we can make some comments here that we think we heard from the Commission.  That will give direction to the Education Committee to fine tune these things.  We think we heard several solutions to what was recommended.

          DR. :  Well, let's move through the rest of them, and then we will come back as we go over them, and you can make the comments then.  That is probably easiest.

          DR. PIZZORNO:  That sounds good.

          No. 32, we are recommending that this be different than what you see in the document, because in many ways we felt that this was the center of a lot of the discussion yesterday.  It was more on No. 32.  We have some recommendations about how to do No. 32 somewhat differently.

          I am not going to say specific language, because we haven't worked it out, but what we would like to do is go along a couple of themes.  One is, I think we all agree that students who are enrolled in CAM institutions should be eligible for this same kind of financial support that students in other health care institutions have available to them.  I am assuming that is not controversial, because a lot of that is happening right now.

          There is an area where there are some kinds of loans that are only available to conventional medical students.  I want to clearly differentiate between students currently enrolled, and then after graduation, graduates being eligible for loan forgiveness programs.  Those are two separate issues.  I want to make sure we are not being confused.

          So Issue No. 1 is: The Commission recommends that CAM students should be eligible for state, and where appropriate, national fiscal support -- my mistake.

No. 32 is only about what happens after they graduate, and the language as presented here does not sound like the Commission would accept that.

          We would like to propose a somewhat different recommendation, which has three components to it.  One is that this loan forgiveness only be available to practitioners who have primary care licensing -- I am not saying direct access, I am saying primary care licensing; second, that it be done in the form of demonstration projects; and third, that it be done in communities where there is pairing with a conventionally trained medical doctor.

          DR. GORDON:  What was that again?

          DR. PIZZORNO:  That the idea of there being CAM professionals available in underserved or rural areas makes sense.  However, it only makes sense if they have primary care training, but not necessarily just direct access.

          Primary care training means they can do physical exams, have some emergency care capabilities, be able to do a PAP smear, things of this nature.  Whereas, those that simply have direct access don't have a broad enough range of skills to be appropriate in a primary care setting, in a rural setting, where there is not conventional care available; second, that this be done in the form of demonstration projects.  So rather than just blanket saying, we should we do this, let's get some funding for demonstration projects.

          Then, third, we recommend that they be paired, at least initially, with conventionally trained medical doctors, osteopathic doctors, in the community.

          DR. LOW DOG:  I would just fully support that.  I think that is an excellent approach, and I think that there are certain groups that are really ready to go into that next move looking at demonstration project.  I think that pairing, initially, is a good idea, and may not be necessary in the future.

          But I think for the demonstration project, I think that is just excellent.  Great recommendation.

          DR. PIZZORNO:  Joe?

          DR. FINS:  We had a conversation last night, and I think that this may be the Talmudic compromise, because what it does is, ethically, it does not remove a provider from an underserved area.  It is augmentation, and the hope is that with the demonstration project that one plus one is going to be equal to more than two.

          For anybody who has been on call 24/7 in a rural area, having another medical provider, maybe with a different skill set, who could take first call on an alternate night and have a little bit of cross-training back and forth, might be a tremendous value-added.

          I think we need to, though, demonstrate its efficacy before we make a sweeping comment about any kind of entitlement.  We need to prove that in these times of emerging scarcity -- I think we really have to kind of regroup a little bit and think about the whole project in light of the national emergency we are in, and all the other claims -- everything has to be proven to be valuable.  I think that the demonstration project is a step in that direction.

          DR. PIZZORNO:  Any other questions?

          MS. GUTIERREZ:  Where does that leave the chiropractor, since we don't do pelvic exams?

          DR. PIZZORNO:  Actually, it is excellent you brought that up, Veronica.  The idea is, and a corollary to this would be, in those states where chiropractors have primary care training, they could practice independently in rural areas, or at least with a trained medical doctor.  If they don't have primary care training, this would not apply to them.

          The same would apply for acupuncturists.  Acupuncturists may have direct access, but no primary care training.  That is the compromise we are talking about here.

          MS. GUTIERREZ:  Define "primary care training" for me.

          DR. PIZZORNO:  I will let Tieraona define "primary care," because we have had this conversation several times now.

          DR. LOW DOG:  I think each state is quite different, because different states list acupuncturists as primary care, in New Mexico now.  So different states have different language on that.

          I think that when you are looking at a demonstration project, you want to take the group to begin with that is probably going to have the most chance of success.

          I think if you asked 100 people on the street, what do you expect your primary care provider to be able to do for you, I think you would get a pretty general feeling: They are supposed to be able to take care of my general health; I should be able to get my woman's exams each year from them; I should be able to have a breast exam; I should have a pelvic exam, basic lab tests; that is supposed to be the person that is able to give me my prescription for my high blood pressure medication; they should be able to meet those kinds of basic needs.

          Then I think that there are all kinds of ancillary folks around that, specialists.  I mean, we like the specialists too, but we don't choose them really to out into the rural areas because their skill set is also limited.

          So primary care, being able to take care of the general health of the average person, really from childhood up through elder age, because that is the reality of people out in rural areas, is that you see the whole scope.

          DR. PIZZORNO:  So, as I read this, again the Committee has to work on some languaging, in a state like Oregon, I believe a chiropractor would be included.  In a state like Washington, they would not be included.  That is the way I read how something like this would work.

          MS. GUTIERREZ:  Well, that is an interesting model on primary care, but in fact for purposes of Medicare, chiropractors are considered primary care, and there are a lot of patients that come into our offices who don't think of primary care as pelvic exams and prescriptive drugs, but spinal care, chiropractic care for chronic conditions, for general health and well-being.

          We see a lot of people on a lot of issues.  There is a whole group of people that don't see the allopathic model as their first choice for primary care, so I think this issue needs a lot more work.

          DR. PIZZORNO:  I am going to challenge you here.  Veronica, we need to draw a line.  We are not going to put a massage therapist out in rural Washington and expect them to provide primary care, and frankly, that is probably too much to ask of the average acupuncturist too.  Where do we draw the line?  How do we draw the line?

          So, Veronica, why don't you say something on that?

          MS. GUTIERREZ:  Well, I don't know how many states massage therapists are licensed in or any other provider group.  I know that the naturopaths are not licensed in 50 states, but chiropractors are.  So I think we should promote what is in the best interest of the public as opposed to singular professions.

          DR. PIZZORNO:  Well, I thought that we were trying, as I understood, to avoid the singular profession identification.

          Joe Fins?

          MR. CHAPPELL:  I think that George called on me.

          DR. PIZZORNO:  Oh, I'm sorry.

          MR. CHAPPELL:  I guess my question is why we draw the line?  Why don't we let the community draw the line and make their choice?  Why do we have to define this part?  Isn't a community going to make its own selection, its own choice and decide what it wants?  Why do we have to set up a more restricted set of eligibility requirements for the funding?

          DR. PIZZORNO:  Okay.  Joe?

          DR. FINS:  I think the lessons of the last three or four weeks suggest that there is a role for government in protecting the public safety.  I honestly think that it is up to the government to say, we are not going to spend dollars on providing access for things for people and individuals that don't provide the basic safety net.

          So, I think what we need to do is to say that, yes, we are going to take this incremental step, but we are not going to be expansive, and anybody who calls themself a CAM provider is not going to be eligible, and that the organizing body that controls this demonstration project will set up criteria.

          We don't need to recommend them what they are, but the testimony can be reviewed.  It will be people with doctoral degrees, post-graduate training from an accredited university with cross-training, et cetera, et cetera.

          It just can't be anybody who is out there.  I mean, people can be harmed by not having access to providers who are appropriately trained, and primary care is a comprehensive skill set.  What we are doing here is we are trying to demonstrate the utility.

          The assumption is that we have a hypothesis that perhaps a pairing of naturopathic doctors and family practitioners and internists in a rural community will be value-added.  It is a speculation.  It is a hypothesis.  It has yet to be proven.  That is what this kind of project would seek to demonstrate.

          DR. PIZZORNO:  Thank you, Joe.  Jim and then Linnea.

          DR. GORDON:  I think this is an inspired idea.  I think what it does is it advances something that is sensible and yet very profoundly revolutionary, and it is something that can be done and that will be responsible and that people will respond to.  So, I see it as a great idea.

          I just want to say I really appreciate the work of the dialogue here yesterday, and the work that you and George, and whoever worked with you over the night, did in formulating this.  It just seems like a really good idea, and I think it will work.  It will work on a public level, as well, that we will be able to get public support for it.  So, that is why I want to go with it.

          The other thing I want to say, just, in my other role as chair, is, we have 16 minutes left.  If we need a lot more discussion about this, then what we need to do is to refer it back to you and let you refine it, listening to the concerns the people have had here, and bring it back to us in December.

          If everybody is ready to go, great.  If we are not, let's just let it go, because we have at least four more items we have to get to.

          DR. PIZZORNO:  Thank you, Jim.

          DR. BERNIER:  I think it is clear that we as a subcommittee have to have another meeting.  I think we learned a lot from yesterday's experience and a lot from last night's.

          DR. PIZZORNO:  Okay, we are going to move on.  Thank you for your input.  We will work on the language.

          Oh, I'm sorry.  I said Linnea could talk.  Sorry.

          MS. LARSON:  My only comment was to say to Tom, to clarify what some of the federal programs are and how we were thinking about how to get this done.  It was an issue about marketplace, et cetera, but I think we need a little bit more clarification of your workgroup to do the work on that.

          DR. PIZZORNO:  I think we could put some language in that kind of sets, here is the general standard and let each community, as defined by states, determine how they are going to do it and what is practitioner appropriate, because it is going to be different, state by state, depending upon the licensing, training, and things of this nature.

          So, let's provide environment, let's say here is what we are trying to create, but let each community do it the way they wish.  I think that should work well.

          Okay, let's move on to Issue No. 6, which is basic or core CAM curriculum for conventional health care professionals at professional schools, post-graduate, and continuing education levels.  We have three recommendations here.

          Oh, and a comment I want to make from yesterday's conversation about the February meetings, please realize a lot of the language in here came out of the February meetings.  There was some assumption that we didn't use what was there.  We used the February meetings, July meetings, et cetera.

          So if you look on the three draft recommendations, after what happened yesterday, I don't know if I should say this or not, but I think these are non-controversial.

          Recommendation No. 33 recommends that a basic curriculum which surveys the CAM modalities, and which probably should say CAM systems and modalities, and ensures basic skills in collaborating with or supervising CAM professionals should be developed for conventional health care professionals in professional schools, post-graduate training programs, and continuing education programs to increase knowledge and understanding of CAM in order to enhance and protect public health.

          I am going to read all three of these because they all tie together.  No. 34, the Commission recommends that the curricula in CAM-funded principles should be developing at conventional health care professional schools in conjunction with CAM experts and CAM institutions.

          No. 35, the Commission recommends that conventional health care providers interested in practicing a CAM modality or system of healing should obtain the necessary education in post-graduate or continuing education programs, or at accredited CAM institutions.

          So is there anything in any of these three people can't live with?  Jim, and then Dean.

          DR. GORDON:  The addition I would have, and it is really that there should be more of an emphasis on self-care in these descriptions of CAM, because I think it is too easy, especially in the context of medical education, to see CAM as simply another technique that one uses, like one uses another herb instead of a drug, and I think there needs to be some sense, even in the recommendation, that we are talking about a philosophy and a way of looking at the world, and not just about what are drug or herb interactions, even though that is also important.

          So, that is really what I would include, both in Nos. 33 and in 34, and that there be practical experience of these approaches, that it not simply be something where somebody does a lecture, this is this, this is what Chinese medicine is.  So, that is my addition.

          DR. PIZZORNO:  Thank you.  Dean.

          DR. ORNISH:  Joe and I were just talking that I know Bill Fair, who certainly is an ardent proponent of CAM, has expressed some concerns that there is such limited time in the medical school curriculum that he said, you know, I don't know that urologist necessarily needs to spend a lot of time learning about CAM, any more than a CAM practitioner needs to spend much time learning how to do prostatectomies.  So, I just want to raise this as an issue.

          Certainly it is like anything else, given unlimited funding, given unlimited time, it would be great.  The question is, any time you put something into a medical curriculum, you are taking something out.  If we are, in effect, mandating or strongly recommending that something go in, then even getting in an hour nutrition lecture takes years in the curriculum.

          Then you can say, well, that is part of the problem, but it is a real issue and it is something you can't just take for granted; we will just add that, because it is a zero sum game there.

          DR. PIZZORNO:  Donald?

          DR. WARREN:  In No. 33, I had something quick.  It says, "or supervising CAM professionals should be developed for conventional health care professionals."

          Does that mean that we look at the aspect of solo practice for a CAM practitioner as being pretty much mandated by the conventional health care practitioner?

          DR. PIZZORNO:  I don't think this defines practices or requires management or doesn't require management.  There are just some situations where it is appropriate for a conventional practitioner to be supervising a CAM professional, and in those situations they need to know what they are doing.

          Joe?  I'm sorry, Jim.

          DR. FINS:  Just to address both of those comments from Don and from Dean, I think educational time is scarce, and I think what the group intended here was basically to allow the allopathic practitioner to be able to work with and understand what was going on, not a completely huge world view, but to understand the relationship.

          Really, in the service, the final point here is to enhance and protect the public health.  So, we are not training the allopathic doctor to become a CAM practitioner -- that is not the skill set -- but just enough so they are familiar with it.

          As far as supervision, there may be times where there is a supervisory relationship, but that we are not in any way mandating.  That is why it is collaborating or supervising.  There may be people who are in your office who are in a joint practice, so you need to know a little bit about their work and their activities.

          DR. PIZZORNO:  Jim and Conchita.

          DR. PAZ:  I think it is entirely possible to include some of this into the curriculum.  The students over at University of New Mexico are already starting to experience that within their classes in various aspects.

          So, even though right at this time it is rudimentary probably, but I think in order to develop it further, it can be incorporated at various points in the curriculum, not necessarily a very comprehensive type of approach, but certainly incorporate it.

          DR. PIZZORNO:  Jim.

          DR. GORDON:  I feel very strongly about this.  I think that already medical schools are doing their best with the support of NCCAM to integrate these approaches, these techniques, and this perspective into all aspects of medical education.

          It can be done.  We are doing it at Georgetown, which is one of the more conservative institutions on the planet, and we are integrating it into everything from anatomy and physiology to surgery and OB/GYN, and we are integrating an experience.

          We can't expect physicians to know anything about self-care unless they learn it themselves.  How are they ever going to learn?  We can't expect them to help their patients with nutrition unless they learn something about nutrition.  So, we are saying it has to be part of the curriculum.

          Amazingly, once it is being said, very conservative faculty are going along with it.  They say, of course, students should know something about it.  The whole world is shifting, and for us to go back and say, we really don't need to know much about it.

          Phil's point, incidentally, is that he doesn't expect physicians necessarily to become acupuncturists, not that he doesn't expect them to know and have some basic experience of self-care and self-awareness and nutrition.

          DR. ORNISH:  I just want to clarify, I am not suggesting that this not be part of the curriculum.  I am just saying that we need to be mindful of the obstacles that are there, and I think it is worth distinguishing between having an awareness of what CAM is, which I think is something all physicians should have, versus being trained in CAM modalities as part of the general medical training.

          I am certainly in favor of the former, but I don't think you are in favor of the latter, either.

          DR. GORDON:  There is no time to train people to be acupuncturists, even if we wanted to, I agree; but I think there are certain fundamental principles and practices that should be part of every student's education.

          DR. PIZZORNO:  Conchita, one final point, then we need to move on.  Thank you.

          DR. PAZ:  One of the things to kind of keep in mind is that some of these changes are coming about because the students are requesting them.

          DR. BERNIER:  Most of the change is coming about because students have requested it.

          DR. PIZZORNO:  Okay, George.

          DR. BERNIER:  I come from a school that has never been judged to be too liberal, but we have really made some enormous strides during the last year in terms of exposing our medical students to the CAM philosophy and approach.  Whether any of them will ever end up practicing CAM modalities is hard to say, but I think it is critical that everybody knows that CAM is out there and that it is part of the medical life.

          So, thank you.

          DR. PIZZORNO:  Now we are going to move to the final recommendations under Issue No. 7.  That is George.

          DR. BERNIER:  This deals with the post-graduate and continuing education for CAM practitioners resembling the ability -- what's available for conventional health care providers.  The draft recommendation is that the Commission recommends that opportunities and funding for post-graduate and continuing education resemble that of conventional health care providers should be developed for CAM practitioners providing primary care to enhance the competency and quality of health care.

          Any comment on that?

          SISTER KERR:  My only question there was why did you say for CAM practitioners providing primary care?  Why not just CAM practitioners?  It is a bit back, I guess, to some of the discussion you all had before about who is doing primary care.  Then, states are different, in California acupuncturists are primary care, legally defined.  We aren't.

          DR. BERNIER:  Does anyone have thoughts on that?  Joe?

          DR. FINS:  I think we are talking about GMP funding and tapping into that source.  I think it raises the same set of questions that we raised earlier about loan forgiveness.  I think that, again, given the massive scope of recommendations in the entire report and the fact that we are facing a deficit and all those kinds of things, I think we need to focus in on the thing that will demonstrate the utility first and foremost.

          So, I think that this may be something that we will evolve toward.  Maybe this goes into the background piece, that, should the demonstration project be effective and show utility, these are the kinds of additional resources that might be marshaled prospectively, going forward.  But it should not be a recommendation, I think, at this point because we have not demonstrated the utility of it.

          SISTER KERR:  I disagree, totally.

          DR. GORDON:  I didn't understand.  Are you suggesting there be demonstrations in this area?

          DR. FINS:  No.  I am saying that you are tapping into funds here that are for residency training programs, as I read here.

          Is that right, George, post-graduate?

          DR. BERNIER:  Post-graduate, yes.

          DR. FINS:  It is really funds for residency training.  What we need to show is that people who have that set of training really have a positive impact through the demonstration projects.  If we show that, then this might be a direction that we would move towards.

          DR. LOW DOG:  I think the recommendation is unclear where the funding would come from.  I think that if you want to go to a master's degree or a doctorate degree.  I know this from my own family, from my own kids, there is certainly funding available.  You can apply for loans, and you can get scholarships and things like that.

          To me, the recommendation isn't really spelling out residency, and it is not specifying GMP.  I think that if that is what you are saying, that needs to be more clear.  I think that the opportunities for post-graduate training and continuing education should be for anyone in any profession, but I would argue that there are funds already available for people to go and to get funding.

          If they are being discriminated against for that, then you should be able to get the loans just like you would to go to university and get your master's degree.  I would support that fully, to be eligible for loans, and if that is not the case, then I think a recommendation should be made, that if you are an acupuncturist and you are going to do further training, that you should be able to get a loan for that, just like my son who wants to go get a master's degree, he will have to take a loan out for that.

          If you are saying something separate about residency, I think we just need to clarify that and put that in a second recommendation, if it is coming from GMP.

          DR. BERNIER:  Okay.  How would you phrase that?      DR. LOW DOG:  I am not on your committee.

          [Laughter.]

          DR. LOW DOG:  I have to do my own committee, George.  But what I am saying is, it seems like there are two issues here.  One is, if you are a chiropractor, an acupuncturist, massage, whatever type of practitioner you are, if you want to further your education, I think that you should be eligible for the funds to do that.  I think that there should be funds.

          If we are talking about GMP, and residencies, and all of that kind of stuff, I think that is a little bit of a separate issue, and I think you need to have two recommendations so that everybody is covered by this.

          I would also say that it is difficult when we can't get national education standards, when we can't get people to agree on even what the education is, it is hard then to try to set up residencies, post-graduates, because everybody is different, nobody wants to agree.  This is coming back yesterday, to trying to come to some agreement for national standards.

          DR. BERNIER:  Thanks, Tieraona.  Ming?

          DR. TIAN:  I think it was very important to provide any support for CAM practitioners to learn conventional medicine and to have post-doctorate training, but, again, in this you are talking about providing primary care, you ask CAM practitioners to do that, that seems to be too much, because you have to go back to medical school to do that.

          Also, for instance, as an acupuncturist, that is an expert, a specialist.  The specialist does not want to take the responsibility to do the primary care, because there is too much responsibility.

          So, it is impossible, because the training in this country for acupuncturist is 1,750 hours, something like that, for non-physician training to be a licensed or a registered acupuncturist, compared with the system in China, it is different, the typical government five years formal training would be 5,000 to 6,000 for Chinese medical doctors, and also they have training.

          I don't like interrupting people, but we have already cut down the time for summary to 15 minutes from 30 minutes, and I want to make sure that we are all on the same page.

          The other thing that I want to emphasize is that even though Tieraona is not on this committee, in effect we are all sort of ex-officio potentially on all the committees.  The way we are going to help the committees move ahead is by helping them where we have a strength or an idea or an interpretation, they need our input on this.

          So, let me go through these and see where we are, because I think we are going to be giving you back a few things, as you well recognize.

          No. 26.  Once the last part of that statement was eliminated, the part from "by amending" on, there was general agreement to No. 26.

          If everyone can read the first part: "The Commission recommends that appropriate access to funding and other resources for CAM faculty curriculum program development at CAM and conventional accredited institutions and by licensed professions should be made possible."  There was agreement for that.

          No. 27.  There was this general sense of agreement, but more detail was needed, and the question about the research was how we are going to put this together with research recommendations here.

          If it seems I've left out something, or something seems awry, please just let me know.  I am just going through this.

          DR. GORDON:  Okay.  Thank you, Joe.

          No. 28 --

          DR. KACZMARCZYK:  Jim, excuse me.  Was No. 27 accepted with changes?

          DR. GORDON:  That is what I understood.

          DR. KACZMARCZYK:  Just asking for clarification.  Thank you.

          DR. GORDON:  Just asking for more detail, more sort of about what it might be like.

          No. 28.  There were a lot of questions about this, and the general sense was this needed to be sent back and reworked, and there needed to be a discussion about pilot projects, staging states' rights, et cetera, those were three of the major issues that were raised for No. 28.

          DR. PIZZORNO:  Jim, I think the message that we heard loudly was there should be some kind of an incremental process here.

          DR. GORDON:  Yes.  That is what I meant by staging.

          No. 29.  There was basic agreement, but again a sense of more detail being needed.

          DR. PIZZORNO:  Jim, could I stop you there?  There was a conversation that George and I had on this, and that is -- and this may be something that the Commission needs to discuss in general -- is, we felt to go much further in this, we were starting to become prescriptive, and we thought we were supposed to not be prescriptive.

          So, we are not sure how to do this in a manner that doesn't cross over some kind of a boundary here for what the Commission could be doing.

          DR. GORDON:  Joe?

          DR. FINS:  I think perhaps in the background section you could flesh out the need and maybe give an example, and yet have the recommendation of people being aware of the kinds of issues that you raise, but not initially saying how it occurs but as background to the recommendation.

          MS. CHANG:  I also have a note that this one was suggested to be merged with No. 27.

          DR. GORDON:  No, with No. 30.

          MS. CHANG:  Was it No. 30?

          DR. GORDON:  With No. 30.

          Any other suggestions about this?  It is clear that it needs the merging, Joe's suggestion about background.  Anything else on this?

          [No response.]

          DR. FINS:  Again, in the background piece, I would really very much like something mentioned about the needs of dying patients and how the practitioner needs to be aware, the CAM practitioner, of that vulnerable population.

          I completely agree with Joe's point from yesterday, that that oncologist who is giving a patient who is dying another round of chemotherapy and not making a referral to the hospice, so too, needs to recognize the limits of his or her intervention.

          DR. GORDON:  I will tell you my feeling about that is that there are many, many vulnerable populations for many different reasons, and I don't think it serves us to keep singling out one population.

          I think we can talk about vulnerability, give a number of examples, people with chronic pain are enormously vulnerable.  I mean, it is just the whole variety of different people, kids with Attention Deficit Disorder.  Whenever the problem becomes insistent or terrifying, either one, there is a vulnerability.

          So, I think we can address the issue and address the different populations.

          DR. FINS:  Maybe for Saturday, we might want to have a section in the background piece for Jim, or something in the beginning about populations that use CAM, and vulnerable populations that use CAM, not just by demographics and ethnic groups as we have discussed it, but based on illness situations or disabilities or problems that people have.

          DR. GORDON:  I think that is a good idea, rather than keeping on repeating the same thing over and over again.

          No. 31.  Again, this is my strong feeling -- I just want to check it with everyone else -- that there is a sense that the way the recommendation is worded does not have the appropriate sense of respect for traditional healers, and that it is sort of "allowed to continue to practice."  I think that there needs to be something, a much more positive kind of statement, and a real framing of the role of traditional healers here that just is not done.

          Tieraona?

          DR. LOW DOG:  I just wanted to raise one issue, because I don't think we really addressed it.  We focused on indigenous practitioners of this country, but it is one of those sort of slippery slopes that you could get people claiming to be a traditional healer from anywhere in anything, and I don't think that was adequately addressed in this piece.

          DR. GORDON:  Buford also spoke about the issue of traditional healers coming into the cities and what happens there, and also about issues of training.  So, it is a much more complicated issue than is framed here.

          Dean, go ahead.

          DR. ORNISH:  I was just going to second what you both just said.  It makes me really uncomfortable that it is almost like carte blanche to say if you are a traditional healer there is no licensure, there is no certification, there is no oversight.

          In the past, there has been less need for that because of the nature of traditional healing.  The apprentice, the teacher, the oversight is embedded in that system, but as that system breaks down with the fragmentation of the traditional social supports and networks that used to provide those kinds of checks and balances.  You see that with spiritual teachers too, and a lot of abuses with that.

          So, my own particular bias would be to say, I don't see why traditional healers should be in a separate category.  Rather, I think my recommendation for recommendations would be that traditional healers work together to develop their own formalization and certification, or licensure, or whatever form that takes.

          There is no reason why they need to be in a separate category, any more than any other CAM modality does.  I think it is really necessary to address that.

          DR. GORDON:  What we are looking for now, and this is clearly an issue on which there are a lot of feelings and thoughts, is for information and guidance for the committee to take back.  So, please go ahead with that in mind.

          Joe and then Tom.

          DR. FINS:  I hear Dean's point, and I agree with you, but I am also very sensitive to the fact that this is a kind of religious expression.  I mean, there is a traditional healer, and then there is a traditional healer who is perceived as a religious presence as well, and we would not want to constrain the expression of religious freedom.

          I think that we need to wrap that language in here.  Using traditional methods of healing versus being perceived as a clergy-person, I think, puts you in a different category, and communities recognize their religious leaders.  So that might be a way of parsing that out.

          DR. GORDON:  Tom.

          MR. CHAPPELL:  I would hope that the edits to this would leave to the traditional communities their ways, their standings, and that we don't try to shape any eligibility that they might have for anything.

          So, as I said yesterday, and I concur with Dean, I don't yet see a justification for a creation of this particular recommendation, unless we simply want to affirm that we want traditional healers to be eligible to the same opportunities that anyone interested wants to obtain through education and training.

          DR. GORDON:  I'm sorry, we are going to have to move on.  I just want to say one background piece of information.  At a number of hearings, we had traditional healers come to us and express their deep concern that, as we move into the whole area of CAM, their rights to practice were going to be limited.

          So, I feel we need to make a statement.  I think we heard that over and over again from many different communities.  We very clearly need to make a statement.  It is a complex issue.

          I would ask everyone who is interested to talk with Joe and George, and to participate.

          Real brief, because we have several more issues.

          DR. LOW DOG:  I just think that the other thing you do need to check is that I do believe the issue of Native Americans practicing on the reservation really is not the purview of this Commission or anybody else, because they are sovereign nations, and they can sanction their own laws.  So, you are really talking about traditional healers off the reservation in how you define traditional community.

          DR. GORDON:  Right.  Also traditional healers from other communities besides Native Americans.

          DR. TIAN:  Quick question.

          DR. GORDON:  Very quick, Ming.

          DR. TIAN:  What is the definition of "traditional healer"?

          DR. GORDON:  Good point.  You want them to develop a definition?

          DR. TIAN:  Yes.

          DR. GORDON:  Will you help them?

          DR. PIZZORNO:  I need to ask a question here, and, George, you may also.

          First of all, we do have a definition here.  We need to get a clear sense from the Commission.  We believe there is a fundamental difference here, that there is one group that practices traditions within their community and that community provides oversight.  That group has specific needs, and I have, personally, a high level of comfort with that group.  Once those people leave that community, I have discomfort.

          In addition, there may be traditional healers that may come from other countries and such, but if they are not practicing within a community that provides oversight, and you might say censure where necessary, then we don't have the protection.

          So, I want to get a clear message from the Commission here.  Is there a separate group that we can identify and appropriately support and protect, or not?

          DR. GORDON:  Tieraona, do you want to speak into the mike?

          DR. LOW DOG:  I would just make the language more clear about that, because "community" refers to a group of people versus a geographical location, and how you define "community".  I think it just needs some tightening up, because the one thing you don't want to see is continued abuse, of people that actually do not belong to a community claiming that they do, and then hiding behind that as a way of not having to conform, to belong to a group.

          DR. ORNISH:  I just don't see why traditional healers are in their own category, why it is different than Chinese medicine or naturopathic medicine, or any other kind of medicine.  I mean, these all come out of traditional healing communities.  They all have a basis that goes back, for many of them, thousands of years.

          To identify one particular group of people as somehow being 007, that they don't need to have any kind of oversight or licensure or certification, I am really uncomfortable with that and don't see the need for it.

          I think it, in some ways, detracts from the strength of the other recommendations that you have, and I am not even sure it belongs in Education and Training, anyway.  It seems to me to be more in the Licensure and Certification section.

          I am afraid that you have got an easy target here that might take away some of the credibility of the other recommendations that are so useful.

          DR. GORDON:  This is clearly a rich and complex area.  I think that Dean's point is one we need to consider, and I also feel that those who are traditional healers here, Steve was suggesting that there should be significant input from all of you to the committee on this particular issue.  They may want to schedule a particular call in which all those here who are traditional healers can participate in that call, and address this particular issue.

          We have been asked by Santeria practitioners, Native American practitioners in cities, Curanderos, and others to make a statement.  So, I feel it is our responsibility to do that, whatever the statement may be.  I think it could be in Licensure.  I think that is something that should be discussed, but it does have to do with training, as well.

          Buford talked about this, as well as a number of the healers, talked about the kind of training.  So maybe there can be a discussion, with the people who are doing licensure, about this issue as well.

          So maybe, Linnea, since you are particularly interested in licensure, you can participate in this as well.

          Joe, we have got to move on.  We have one minute left to go through this, and I don't want to take away time.

          No. 32.  This is clearly complex.  We will make sure we set aside time next time, and maybe if you could come up with a couple of options, a couple of ways to consider this, taking into account Dean's thought about licensure.

          No. 32.  There was a revised version, which we are looking forward to seeing in writing and to talk about next time of that, relating to demonstration programs.

          Nos. 33, 34, 35.  There was concern for making this a little more specific, getting a little bit more feeling for it, perhaps providing some of the background for what is already happening at medical schools around the country.

          No. 36.  I think there is still a good deal of unclarity about this whole No. 36 and No. 37 issue.  The way I read this, this does not have to do with the substantive things.  One is with funding of opportunities, and the other is with the possibility of programs, specific kinds of mixed residency programs, for example.  Like, David Eisenberg has a kind of fellowship program up at Harvard, with chiropractors and MDs and acupuncturists in it.

          So my sense from the discussion is that you need to address the two things, one is what kind of loans, ordinary loans, should be available to people as they pursue post-graduate education, and then the other is, are you recommending that there be programs -- hearing some of the difficulties, but perhaps also some of the possibilities -- programs in which people of different professions have post-graduate education together.

          That is the implication of No. 37, which I don't think is spelled out.

          DR. BERNIER:  That is right.  We didn't really get to it, but you are right, Jim.

          DR. GORDON:  We have time for very quick comments, because we are over our time.

          Go ahead, Veronica, and then Joe.

          MS. GUTIERREZ:  I would like to request that the committee define the phrase "primary care" for our next meeting, because I have given a lot of thought, and I can't figure out how a CAM provider would do a pelvic and breast exam differently than a traditional medical doctor.

          DR. FINS:  They are trained to do it.

          DR. GORDON:  In No. 36 and No. 37, primary care is not in those two recommendations.  It is in an earlier recommendation.

          DR. BERNIER:  It is in No. 36.

          DR. GORDON:  Can this input be given to the committee?  Because we really need to move on.  I don't want to shortchange.

          What I would appreciate is if all of you who have something to say could speak with the committee members.  We are going to be shortchanging one group to serve this group.  I would really like for us to stop any further input.  Please give it to Joe and George and Joe K., and they can move ahead with it.

          Thank you very much, both for your presentations and your willingness to really rethink and look at this very important area.

          DR. BERNIER:  We want to thank the Commission for giving us the extra chance.  Thanks.

          [Applause.]

          MS. CHANG:  The facilitators for the next section asked for one minute for a bathroom break, then we are going to move immediately into Access and Delivery.  The facilitators are Dr. Joseph Fins and Linnea Larson, and I was the staff lead.  We will be moving down there in a second.

          [Recess.]

        Session V: Access and Delivery for CAM

          MS. LARSON:  I would like to begin this session, Access -- I was going to say Access and Discovery -- it is Access and Delivery, and we will discover quite a few things, I hope.

          My co-facilitator, Joe Fins, will be here presently.  I want to thank all of the members of the workgroup and name them, Buford Rolin and George DeVries, Conchita Paz, Joe Pizzorno -- let's see, who else -- Julia Scott and, of course, Joe Fins.  Thank you for working quite diligently and answering most of all the conference calls.

          DR. FINS:  We also want to thank Michele for an absolutely superb job with this on short notice and some very complicated issues, and I think we are all indebted to her, on the subcommittee.  So thank you very much for that.

          MS. LARSON:  Our group has Recommendation Nos. 38 through 49.  We have two placeholders, which we do need to do some further discussion on about why we have those placeholders here.  I want to give a small overview about the concept and the process that we came to on access and delivery, and how we framed the issues of access.

          One of the significant things is that access actually refers to who is available and what is affordable, and then the logic of it was, this is basically a regulatory activity and we will be looking at legal authority, which then leads to the issue of licensure.

          That is how we are just cutting straight to the heart of the matter, putting licensure right on the table.  So, if you looked at the reasoning or the development in the first issue, you will see those issues kind of played out.

          I thank Michele for this.  She alerted us to this excellent report done by the Pew Foundation in 1995, that did a pretty thorough job looking at regulation in the health care workforce.  I hope that people had some time to review that document, because it really helps and adds some substance to the recommendations that we have focused on.

          Do you have anything to add to this one?

          MS. CHANG:  I just want to add that that report has been updated.  It is in your briefing books.  It has been updated, and we are in touch with the group that is working with that report.  They have begun to address some issues around what they call emerging professions, so we will continue our research into this background piece and offer that as part of the background for this section.

          MS. LARSON:  I want us to take a look directly at issues on licensure and specifically page 6, so we get come clarity of definitions.  This was material provided by Michael Cohen in his testimony, I believe it was in December -- February.

          Talking a little bit about the process.  It took us a while, as a workgroup, to actually be clear with each other about what licensure meant and what were the different issues around certification versus licensure versus registration, et cetera, and that is one thing the Pew Report actually points out is there is not uniformity in the terms, what defines certification or licensure or registration from state to state, but this is the general model of what constitutes licensure.

          SISTER KERR:  Just a clarifying question, and I will speak to this later, but did you use the guiding principles as sort of a check off for whether or not these recommendations are consistent with the values of the Commission or what we are pursuing, because I know this area is almost in some way a little different, but yet -- so, just if you could answer that?

          MS. LARSON:  I can say, just answering you personally, I am not going to answer for any other member of the workgroup, that I did not directly refer to the guiding principles in my conversations in my conference calls.  I do not believe that I was not mindful of the guiding principles, but if you can point out maybe where I have, then please do.

          DR. FINS:  I think this section is really fleshing out options and ranges of alternatives.  We didn't necessarily come down on what a state should do, because, as we will get to, it is a states' rights issue, and we felt that we could advance the discussion by laying out the range of options that exist, the kinds of possibilities for really the regulation of CAM practice.  In that, I think not explicitly but I think implicitly, we were informed by the need to protect the public health, to promote access, to foster choice, which are three of our important guiding principles.

          Also, we didn't want to have one-size-fits-all.  In other words, we didn't want to say that everybody needed to have mandatory licensure if, for example, they were doing something that could have a lower level of regulation because it would increase choice.  On the other hand, if they were doing something that had a higher public health risk, for example, then they may need a higher level of regulation, so it was kind of balancing access and safety, and that was the pendulum.  We tried to just flesh out the options, so that states, in making their determinations, could find the right balance for themselves.

          Now, there will be variation from state to state, but that is a federalist issue.

          MS. LARSON:  I would like to make this additional comment.  One of the great difficulties is being not only clear but be inclusive, and being quite mindful of what we, as a Commission, can be able to say to people and to states and also the recognition that states do have the power and the right to set their own rules and regulations for licensing, but also clearly stating that we want to get to the point where the emerging professions and the professions that already have formed have the necessary regulatory overview or oversight.

          Actually, I would like to ask any of the workgroup members, anyone else, if they have comments to make on this particular document?

          DR. PIZZORNO:  I just want to say I found the Pew Commission Report extremely helpful and very insightful, because I think it provided a pretty objective and compelling way of looking at this whole area of licensure.

          DR. GORDON:  I just wanted to mention one thing.  There was a follow-up on the Pew Commission Report that I was on on licensure and accreditation, there was a task force on that, and it might be good to get hold of that, because we specifically addressed CAM professions.

          MS. CHANG:  We actually are in touch with them to discuss that.

          DR. GORDON:  Great.  Good.

          MS. LARSON:  Yes, George?

          DR. GORDON:  I just want to say I thought it was a terrific subcommittee and that you did a great job in running it.

          MS. LARSON:  Thank you for your gracious comments.  I will accept them.

          I want to solicit commentary from the workgroup again.

          No more commentary at this time, so let's go directly, I believe, to the recommendations under Access and Delivery, then maybe we will work backwards.

          DR. FINS:  The first is on page 8.  It is Recommendation No. 38, and it needs to be edited just slightly.  The Commission doesn't endorse the Report, but it concurs with the recommendations in finding it especially relevant to the regulation of CAM practices.

          Again, the language that is throughout here is soft language to the states, recognizing our federal constraints.  States are encouraged to use these recommendations as guidance in developing regulations for CAM practitioners.

          Any thoughts or comments?  Yes.

          DR. GORDON:  Joe, a statement like that, I feel you need to give a sense of what that means, even in the piece.  Somehow it is got to be tied in, what is that all about, and in some pithy way, it seems to me, so that the recommendation, standing on its own, will make sense as a recommendation.

          The other thing I would like, as a piece perhaps for background, is who cares about the Pew Commission anyway, because the way it is presented here, it is just like, okay, they said it, so let's do it.

          DR. FINS:  Good point.  I think we need to say who was on it, and what was their charge, and a little bit of background.  If you look on pages 6 and 7, on the Challenges section that leads up to these recommendations that we didn't go through in the interest of time, we are making the argument about why there is a need for this regulatory approach.

          So it is there.  It is set up.  The ambiguity and variance, and the need for legal authority, conflicting practices from state to state, et cetera, et cetera.  So, it is on page 7.

          DR. GORDON:  I think that part was very well done.  I think the issue is why are we quoting another report.

          MS. LARSON:  May I answer this?

          DR. FINS:  Please.

          MS. LARSON:  This is for clarification.  The other day I made a suggestion to Tom Chapel and to Wayne Jonas regarding contextualizing their use of crossing the quality chasm, and the similarity of the guiding principles in that document and our 10 guiding principles, and I requested that they flesh that out in more detail.

          And that is specifically what you are asking.  Thank you.

          DR. FINS:  I think, Jim, there is another value to this, another group that did not necessarily have the perception of ideological baggage that this group has has made recommendations, just like the IOM has a kind of the imprimatur of that great institution.  So, I think that is why we are trying to find linkages, that we didn't just develop this out of the box with a kind of ideological slant.

          DR. GORDON:  Right.  I am in agreement.  I just think it needs to be made clear, and where the authority of the Pew Commission comes from, and how interesting it is that coming from where they are coming from and us coming from where we are coming from, there is so much agreement.

          MS. LARSON:  I totally agree.

          DR. FINS:  Other points on No. 38, with those additions and recommendations?  Effie?

          DR. CHOW:  I really think it is important utilizing the existing concept that has been derived from traditional means.  I think it is also important, then, to delineate what is special with CAM, and not to be seen as, well, there is that, so it is spoken already.

          So, we need to be very clear to delineate what is special about CAM that goes beyond this.

          DR. FINS:  Good point.  That, in fact, is what the subsequent recommendations seek to do.  The Pew Commission Report was not exclusively, in any way, focused on CAM, it was really a generic health care workforce report, so we are adapting that and modifying it for the CAM context.

          Maybe it would be helpful, since No. 38 is sort of a generic statement to go to this specificity that Effie is talking about and go to the next recommendation, which begins to flesh that out.

          No. 39 is that we recommend that CAM practitioners who demonstrate appropriate competency based on established standards, such as education and training, should have the legal authority to practice.

          Now, there is a lot embedded in here, and we may need to flesh it out some more, but basically we are making a quid pro quo argument, if you have education and you have training and you satisfy those recommendations or regulations, based on your state, then you should have the legal authority to practice what you worked so hard to achieve.

          So, it is not that people can just practice, they have to demonstrate the competency and the educational training, and it is a quid pro quo.  It is a relational kind of authority.

          DR. WARREN:  Established standards.  The states aren't going to establish those standards.  It is going to be the professional groups that establish standards, and it is like we have heard, we can't get a solid voice from any of these groups, we have got such fragmentation.

          Another thing I want to ask, this Pew Report is phenomenal, but yet it was done in 1995 and I haven't heard squat about it since then.  What has happened with it?  Has it been swept under the carpet?  If it is, are we going to attach ourselves to a sinking ship?

          MS. CHANG:  Actually, let me address that because, as I mentioned before, they have done an update of this, there are more recent publications that are in progress that we are talking to them about, and, in fact, that may have more relevance to CAM because they are addressing some what they are calling emerging professions.

          DR. WARREN:  We are not going to rewrite the Pew Report, then?

          MS. CHANG:  No.  They are not rewriting it, but we a re in touch with them.  Between October and December, we will do a little bit more background and add more background on what has been done since 1995.

          DR. WARREN:  Okay.

          MS. LARSON:  I think he was asking the question about association with why wasn't this report known widely and an association.

          I actually want to answer.  I actually do not know why, and I don't know to what communities and to whom it was given and who has read it.  On the second issue, too, about association, this is my belief, it is not done by proof, is I think that a body that has been given the task of coming up with those recommendations and the rigor at which it was done, and certainly that document is substantial, I think it would be a pretty positive association.

          DR. GORDON:  Don, I just want to mention the task force, there were task forces that followed the Report.  The one I sat on was one of those task forces, and it was specifically focused on licensure and credentialing, and I think that report may give some specifics here.

          I can't answer for the whole report.  It is a difficult process to get people to pay attention to reports.  With the licensure and credentialing, what we tried to do is just to go to the different state licensing boards, present it to them, have Pew staff talk with them or the task force on the health professions, UCSF health professions divisions, talk with them.  So, it is a complicated process, and I think the illuminating part, of course we are going to have to deal with the same issues, how are we going to get our report -- and this is something we need to be talking about as we move ahead -- how do we get our report, however hopefully brilliant it is, to have that kind of effect where we want it to have an effect.

          DR. WARREN:  It will be hard to buck the good old boy syndrome.  I mean, to try to put something in, to get some board or regulatory body to accept, because it was given by some outside entity, it wasn't one of the good old boys that came up with it.  Does that make sense?  It is Arkansas slang.

          MS. LARSON:  It makes an awful lot of sense.  I would actually like to come back to that with your explanation to me this morning, but Tom does have a comment to make, and so does Ti.  So, in that order.

          Tom, please?

          MR. CHAPPELL:  I am thinking about how we can incorporate the Pew recommendations into our language and our document, and my recommendation of how we do that is to claim each recommendation with citation to the Pew document, but to build on the recommendation with just focused language on the CAM profession.

          I think it is very important to incorporate the recommendations into our document and to cite Pew, and then to direct that recommendation specifically to CAM issues and practices.

          DR. FINS:  I think that is really helpful, and maybe as a generic statement for all of the recommendations.  The way we have basically done it, we have made an argument about the challenges, then we make the recommendation.  It seems to me that what Tom is suggesting is that we have a justification underneath the recommendation, where, in this case, we would cite the Pew Report and that relationship, but in other parts of the Report, we would just argue why this is justified, why a demonstration project would be justified.

          MR. CHAPPELL:  But this way, you own it, and it is your material when you hand it out.  You are citing another report.

          The other thing I want to say is the more we can get foundations to do focused research in any one of the topic areas of our domain would be fantastic.  I mean, just because we have committees and just because we have given some time to it doesn't mean we are the experts on these things.  It really is great that there has been some private foundation money here given to focus on something, and look at the clarity of thought that came out of it.  It is a good model.

          DR. LOW DOG:  I just wanted to go back to Don's original comment, question, statement, which was about based on established standards and the fact that they vary so much, in states that are looking at this, where do they look when there are so many, and is there any way to make this more clear, and does it raise some of the other issues that we have talked about earlier, as well.

          DR. FINS:  We spent a lot of time talking about this mechanism.  I don't think it made it into the Report, but, first of all, we wanted to advance the framework and the options that states would have.  In other words, we think if they read this, they will be a little bit further along in making those determinations, what are the appropriate standards and how do you orchestrate this.

          We talked about the uniform code, and there is a body that is sort of extra-governmental, appointed by governors, that get together, that help states write their laws, drawing upon the collective experience of other states.  So, we can put some of that stuff in as possibly the kinds of fora that would be used to have these discussions.

          But I think Don's point shows the interrelationship between all the things that we are talking about that an emerging profession that is not yet a profession that doesn't have a consensus on what the standards are may not be the kind of entity that would qualify for the highest degree of licensure.  It just may not be there yet.

          So, it all goes back and forth with education and whether or not a practitioner is part of an established profession or not.  I think we can't force things.  Things are going to evolve over time.  I think our job is to help set up mechanisms within government, within the federal and encourage the states, so that when practitioners evolve to the next level, there is a receptive mechanism for them to go to the next step of regulatory oversight.

          MS. LARSON:  I am going to read No. 40:

          "The Commission urges states to include a diversity of qualified CAM practitioners on any workgroup, task force, or regulatory body established to review regulations and clinical practices to make the regulatory process accountable and transparent to the public.

          "The Commission urges states to utilize a broad base of representation, including allopathic clinicians, consumers, and payers of health care, as appropriate."

          DR. GORDON:  I am not sure I understand why you are singling out allopathic clinicians in the second sentence.  I mean, to me it would be CAM.  It has a slight feeling of the allopathic physicians being the supervisors of the process, and I would rather have them as part of the mix.

          MS. LARSON:  I would like to speak to that with a little bit of history, and if memory proves me correct, I believe that that was one piece that, actually, Joe Pizzorno added.

          Can you speak to that?  Is my memory correct?

          DR. PIZZORNO:  I think the intent was probably similar to what Jim was saying, that is, we want conventional practitioners, we want CAM practitioners, and we want the public involved in making these decisions together in regulatory processes, that's all.

          DR. FINS:  The background model for that was basically some of the state medical boards that were persecuting doctors who were using pain medicines appropriately, and the recommendation in many states, including New York, was to have palliative care doctors on those review committees to sort of have expertise.

          So, basically we just want to have those oversight bodies appropriately constituted.

          DR. GORDON:  I think it has got to be worded a little more clearly, because one of the major battles that goes on with licensure is who is going to be in charge of whom when there is a new profession coming in.  So, when the massage therapists in Maryland come in, they don't have their own board.  They are under the chiropractic board, and that has certain strong implications.  In D.C., when the acupuncturists came in, acupuncturists were under the Medical Board, and that had certain implications.

          I don't think we are in disagreement.  I just think we have to be very careful about the way it is worded, so it doesn't look like one group is going to be in charge necessarily of the other.

          DR. FINS:  Jim, are you proposing at this stage that we make a recommendation that a state would be encouraged to have each profession have its own board?  Or, a more incremental approach?

          DR. GORDON:  I think it may be different in different places.  I think the fact that there are two sentences here implies that somehow the second sentence is addressing a different issue from the first sentence.

          In the second sentence -- this is a matter of wording, and I want to make sure it is not a matter of meaning -- in the second sentence, only allopathic clinicians are mentioned; and in the first sentence, allopathic clinicians are not mentioned.  So, instead of having everybody involved in the process, it looks like there are two separate processes.

          DR. LOW DOG:  So, just make maybe one sentence.  The Commission urges states to include a diversity of qualified CAM practitioners, as well as allopathic clinicians, consumers, and payers of health care, as appropriate, so that it all just reads as one.

          DR. FINS:  Okay.

          DR. ORNISH:  It is not entirely clear to me, as the conversation is evolving, what constitutes a profession.  I mean, let's say we have the Jim Gordon method, and Jim Gordon says, I have a new system of healing --

          DR. GORDON:  I am glad you are using that as an example, Dean.  It is an important one.

          [Laughter.]

          DR. ORNISH:  I am trying to curry favor with the Chair, actually.  It is not working, though.

          Seriously, though, say I have got my own profession.  I have this new, wonderful system of healing.  I am going to police myself.  I am going to set up a board of other people that I have trained to monitor and police it.

          I think we need to make it really clear, particularly if we are evolving toward the direction of professions having their own self-regulating boards, who defines what a profession is.

          DR. WARREN:  But your comment, it is pretty much like the medical and dental boards are right now.  A bunch of good old boys get together and they assign their peers, their like minds, to be the regulatory, self-policing.

          DR. ORNISH:  So, does that mean that Jim should be able to set up his own board and do the Jim Gordon method, or the James Gordon method, as the case may be?

          DR. WARREN:  I guess if Jim got enough Jims out there, yes, he could set up his own board.

          DR. FINS:  I can't find my version of this, but it is in Access and Delivery.  We actually have a taxonomy that we spent a lot of time working on, which helps to flesh out that question about whether or not you are a profession, or an emerging profession, or whether you are ever going to be a profession.  It looks like it is pages 2 and 3, under Table 1.

          MS. CHANG:  When you all were sent your separate cover, it had a cover letter, and then at the back of that discussion there was Access and Delivery.  Then there were the background reading materials, the Pew Report, and then the medical school piece.  Then there followed an overview of CAM practitioners.

          DR. ORNISH:  That all assumes that you have already defined what a profession is, though.

          DR. FINS:  Jim, I think it might be worth going through this just briefly.

          DR. GORDON:  Incidentally, I want to just check.  George, you have to decide now whether you are going to need the full two hours.

          MR. DEVRIES:  What are you offering?

          [Laughter.]

          DR. GORDON:  I am not planning to take it away.  Rumor has it that you were saying you might not need it, and if you don't, I would like to know.  We have time now, but we are clearly going to look at some background material.

          MR. DEVRIES:  I understand.

          DR. GORDON:  I want to know if you feel you can give up some of your time?

          MR. DEVRIES:  Why don't we go, say, 90 minutes.  Let's give 30 minutes.  These are obviously important issues, and I think we can do it in 90 minutes.

          DR. GORDON:  That is all you had, anyway.  You had 90 and I had 30, and I was going to give you some of mine.

          MR. DEVRIES:  Okay.

          MS. LARSON:  We don't need to borrow time.  We are fine.

          DR. FINS:  This clarification will help our friends in Coverage and Reimbursement, because it is related.  It is a related kind of issue.

          MR. DEVRIES:  So, why don't we cut ours from two hours to an hour and a half, and then you and I will split the hour and a half.

          DR. GORDON:  All right.  Let's cut it to an hour and 40 for now, and then let's see where we go from there.

          MR. DEVRIES:  Okay.

          DR. FINS:  This is certainly open to your commentary, but let's just go through this.

          Dean, again, we are just trying to draw the boundaries.

          On Table 1, No. 1 is: "The most evolved category of professional status is comprised of providers with an established, well-articulated and cohesive healing philosophy, defined practice standards, and accredited education, state licensing, documented safety, and at least some research substantiation of effective outcomes.

          DR. PIZZORNO:  Joe, could you hold for a second until people can find this document?

          MS. LARSON:  It is the last before Coverage and Reimbursement, the last two pages.

          DR. GORDON:  Is this Table 4?

          DR. FINS:  No, Table 1.

          DR. GORDON:  Table 1.  This is the one that says "Taxonomy of CAM Professional Readiness."

          DR. FINS:  Right.  Maybe before I start there, I will just refer you to the definition of "professional" in the italics above, from the dictionary.  It is defined as "One who adheres to technical and ethical standards of a given profession.  Both imply standards for education and training, as well as a code of ethical practice."

          What we sought to do was to set up four categories.  That first category, I will just continue:  "These holistic MDs may best fit into this category," as an example, "although they may continue to identify themselves primarily as conventionally trained clinicians, practicing 'collaborative' or 'integrative' medicine."

          The second category: "The most dynamic category of professional evolution is comprised of those groups of lay and inconsistently trained practitioners who are working to establish standards.

          "It is important to note that many of the modalities or disciplines included in this category may have rich historical traditions that, in other countries, may be well-established as a healing practice, while, in this country, may still be considered innovative."

          The third group are: "Self-proclaimed" --

          DR. GORDON:  Do you have an example or two of that, Joe, just to illustrate it?

          MS. CHANG:  Joe, lay homeopaths was one example that you had provided, I think, under this second category.

          DR. FINS:  The third group is: "Self-proclaimed or minimally educated healers who practice without apparent standards or community oversight, comprise the currently least dynamic category of professional readiness.  These practitioners may use titles associated with more evolved CAM professions, but do not adhere to educational training or other practice standards established by those professions."

          Then the fourth are: "Two types of practitioners that lie outside of this evolutionary paradigm, and these are, (1) conventionally trained providers who utilize therapies and practices that are highly controversial or excluded from conventional standards of care, and usually do not identify with a specific CAM profession but may ascribe to certain empirical philosophies that tend to characterize CAM rather than allopathic approaches.

          "Most often individual practitioners, they are unlikely to organize as a profession, so they are sort of Lone Rangers, and focus their efforts on the development of their particular and unique technology or approach."

          A related group outside of the evolutionary paradigm are traditional healers who practice within a community that provide centuries-old traditions and oversight, such as Native American healers, shamans, Curanderos.

          They also do not identify with a specific CAM profession, and often relate only to their cultural origins in an organizational sense, with little interest in recognition outside of their own communities.  These practitioners are also unlikely to evolve along organizational lines, which has relevance to what we were just talking about in the last session.

          So, we are saying here this is not a recommendation, this is not necessarily something we have to vote on, but we wanted to try to flesh out a kind of a risk stratification that would be valuable to the states.

          Ti?

          DR. LOW DOG:  I guess my only thing would be on Table 1.  I don't think we should put holistic MDs as our example there.  I think that there are examples of CAM  professions that represent that, that have a cohesive healing philosophy, practice standards, accredited education, state licensing -- I think chiropractors may be a good example of that; registered dieticians are another -- that we continually sort of leave out of this dialogue, but we did include nutritional therapy.

          So I think that there are some that might be better than putting sort of holistic MDs in our CAM document, or put it in addition.

          MS. CHANG:  Actually, we had examples under each of these categories and then decided that trying to be consistent about not identifying a singular profession, we took them out.

          The holistic MD -- and, Joe Pizzorno, jump in any moment here -- we had a real difficulty where to place them, because they are not CAM professionals in that sense, they are truly a mix of the two, but we didn't want to create yet a third outside the paradigm.

          DR. LOW DOG:  I understand what you are saying, but when you read it, it sounds like they are the most evolved, the holistic MD.  It doesn't read quite right to me, though I understand what you are saying.  If you are going to give an example, I think you are going to have to give several.

          MS. CHANG:  And it should be an additional, almost a sub-component to this category, not as an example, classic example.

          DR. FINS:  As a group, do you all think is it better to have examples, or is it going to be more offensive if we have examples?

          Dean.

          DR. ORNISH:  Well, I am just confused.  Putting aside the examples, which, to me, are less relevant right now, how does this taxonomy tie in?  At what level are you suggesting that someone be able to develop their own self-regulating boards, as opposed to coming under the auspices of another existing board?

          MS. LARSON:  I don't think that we are saying that.  I think that we are giving enough room to state, to establish within certain boundaries that really reflect the education in accredited institutions and to then set the standards for what constitutes a profession.

          DR. ORNISH:  I would agree with that approach, but I think it should be stated explicitly.

          MS. LARSON:  You want it tighter, is that what you are asking?

          DR. ORNISH:  Just clearer.  I think you need to say just that.  You say, we think it really belongs to the states to decide what level of evidence or what level of documentation or accreditation constitutes a profession that can be self regulating versus an emerging profession that needs to be, for some period of time or whatever, under existing regulatory bodies.

          I just think if that is what we are doing, then we should just say that.

          DR. FINS:  We actually, in the background section, again, above those four categories, there is some of that language there.  Just trying to talk about the readiness of a profession for independent oversight.

          DR. ORNISH:  But not just in this section, but the one before it.

          DR. FINS:  I understand.  Who is next?

          MS. LARSON:  I believe it was Effie and then Tom and Veronica.

          DR. CHOW:  Thank you. I think this is a great beginning on sort of the definition or defining the criteria, and it sort of matches with the mechanisms for regulation on your page 6, in your outline here.  I think there should be more than holistic medical doctors example.

          But also, do you mean, in No. 1, that it is a well-articulated, cohesive healing philosophy, defined practice standards, does that mean national licensing?

          DR. FINS:  It is not licensing; it is that there is a consensus among the practitioners of that modality that everybody agrees to.

          DR. CHOW:  But you see that everybody doesn't really agree.

          DR. FINS:  The point then, Effie, is, that is not a most of all profession, it may be an emerging profession or it may never be a profession.  In other words, to fit into this --

          DR. CHOW:  I am suggesting there is something in between one and two.  For example, naturopath, there is still not total agreement in the naturopath, acupuncturists, there is not a total agreement.

          DR. FINS:  The point here is that we are saying that if these are points on a continuum, okay, then all of these groups could be plotted on that continuum.  They are either stuck where they are or they could be moving towards a more evolved state.  I think it is probably best we don't try to categorize groups, because there will be different interpretations.

          What this is is a heuristic device to try to get people to understand that this is a moving target and professions are in various states of movement.  That is all we are trying to say here.

          DR. CHOW:  All I am suggesting is that there seems to be another definition needed between one and two, because you are talking about well articulated, cohesive healing philosophy.

          DR. GORDON:  This is a process question.  How much time do you want to spend on this background piece?  I think we really need to move toward the recommendations.

          DR. CHOW:  Okay.

          MS. LARSON:  We have about five more minutes.  If you would like to work on this, Effie, I would really appreciate your writing something.  Tom?

          MR. CHAPPELL:  I think this is a wonderful contribution.  I would like to ask the subcommittee on CAM definition and guiding principles to look at this as a possible inclusion in the definition of CAM.  It is a nice clarifier, because, as you remember, in our description of CAM, we have one chart that just has everything, every profession listed in alphabetical order, and I am worried about the way we presented that in our piece, because the reader might say, well, this is what I have been talking about all along, you know, this is unmanageable, and so on.  This begins to give some manageability to it.  It is very well done.

          MS. LARSON:  Thank you.  Are you suggesting that the two workgroups work together?

          MR. CHAPPELL:  I was only asking permission for our committee to consider including this in the definition of CAM, that's all.

          DR. FINS:  What we were trying to do here is, I think, to Tom's point, is that we say let's regulate CAM or let's reimburse CAM or let's do research on CAM.  There are different elements of this very heterogenous group, and at least in the context of the practitioner moving towards professional, we were trying to just put it into categories.

          MR. CHAPPELL:  Throughout the hearing process, we have been encouraged to do something like this.  People are saying all CAM practitioners are not the same.

          MS. LARSON:  Veronica and then Joe and then Dean.

          MS. GUTIERREZ:  My rubber stamp comment is there are many healing philosophies that are not appropriately classified as medicine.  I would like to see collaborative or integrative care used as the descriptive phrase here, not medicine.

          MS. LARSON:  Joe.

          DR. PIZZORNO:  Two comments.  Thanks, Tieraona, for bringing up that challenge here, because we are trying to figure out which category best fits the holistic MDs, but not to say that MDs are the example.  I think it is important to realize that the purpose of this is to address a challenge that we have been experiencing, not just over the past couple days but in the last year, and that is it is such a heterogenous group.   We have to develop striations to best determine what education, regulatory, practice standards, et cetera, are appropriate for each group.  So this is our effort in doing that.

          I personally like the idea -- and, Tom, I like your bringing this up -- of providing examples for each of these categories, but being really clear that they are not meant to be exclusive or prescriptive, because people need to have some feeling for what belongs.  So, Effie, I think it is important we not expect there to be utter cohesiveness within a particular profession.  I think acupuncture has plenty agreed-upon commonalities that fit well into No. 1.  Of course, there is diversity within the acupuncture profession, but it clearly fits into category No. 1, just like in conventional medicine, you take a given patient --

          DR. FINS:  Joe, in the interest of time, I think this is a very rich discussion, and I think that we can put this in the background section, it was meant to move towards the recommendations, but I want to go to Wayne, and then I want to move on, if possible.

          DR. CHOW:  Excuse me, can I just clarify?  I didn't expect a cohesive -- it is just what is stated here.  It is not my expectation.

          DR. JONAS:  Just in terms of including this in definitions, we actually had extensive discussion about this whole item.  I think it would be possible, as long as there were other ways in which complementary medicine is classified according to different perspectives.  This one is very much based on the regulation, and so I think it clearly belongs here.

          There are other ones on research that belong in research, for example.  If we want to summarize those in some way in the overall definitions, so people see the diversity and the range of description, I think that might be useful, as long as they are not eliminated from each of the subsections.

          DR. FINS:  It was really an instrumental categorization.  Jim?

          DR. GORDON:  I think including some of that in the beginning in definition might be very useful for all the sections.

          I want to come back to the question that you raised, though, 39, and Dean's concern about it.  The way I read this is it is saying as opposed to waiting for states to make the determination, I read this as saying to states, get with it, start licensing professions that have developed a body of knowledge, a body of education in schools that are accredited.  So, I need to know what we are talking about here in this, what the effect of this is.  Are we making a recommendation to states?

          DR. ORNISH:  I would say a third alternative, which is the language that is in 39 I can live with, if it is qualified by saying that we defer to the states' determination on which of those are.

          DR. GORDON:  Right.

          DR. ORNISH:  I think it should be the states' determination, just like gambling or anything else.  There are certain things that the states should be able to do.

          I have a bigger question, which is, the Interim Report has gone out, and, presumably, we are going to be getting feedback based on that.  We are making recommendations yesterday and today and tomorrow that, presumably, are going to be our, more or less, final recommendations, yet we are doing so without having had the benefit of the feedback of the people of the people that have read the Interim Report.  I am wondering is there a time that we can modify this or go through this again based on what feedback we are going to be getting?

          DR. GROFT:  I think the idea is that we would provide all the feedback that we receive to the Commission members during the next six weeks, before we come to the finished writing of the draft report, I think before December.  So, the opportunity will be there to take into consideration what is sent back to us and then to modify as the workgroups feel appropriate.  We will maintain the workgroup status, as far as looking at everything.  So, any appropriate comment that would come in, not only will we give it to all the Commission members, but to the appropriate workgroups to consider, as well.

          DR. GORDON:  I think, just to respond, precisely because we didn't make recommendations, even though we gave a sense of what we are hearing, we are unlikely to get the kind of precise and pointed critiques or too many of them that we would if we had made recommendations.  So, we will get feedback, but we may not get as much as we would like.

          DR. ORNISH:  I am hearing that as an implicit criticism, but that is okay.  I do think we are going to be getting a lot more -- at least I hope -- feedback, even without the explicit recommendations, and I think that that feedback is going to be really helpful, and I am sure we will modify, at least to some degree.

          DR. GORDON:  I agree with you on that.

          DR. FINS:  Let's move on, because we want to have more recommendations to share with people to get feedback on.

          DR. GORDON:  Do you want to redevelop this recommendation, or do you want to --

          DR. FINS:  I think we have a sense of what the concerns are, and we will bring it back to committee, and we will work on it.

          Let's move on.  We did, I think, 40, with the changes that Tieraona suggested.  No. 41 is that the Commission recommends that the federal government set up demonstration projects in states to develop and evaluate competency-based regulatory mechanisms and the effects of exclusive scopes of practice on access and delivery of care.  Maybe Joe Pizzorno could just say a little more about that.

          DR. PIZZORNO:  Actually, this was your idea.  I think you should say more about it.

          DR. FINS:  It is basically a way of helping the states resolve some of these kinds of issues and looking at mechanisms in a critical fashion, because we are saying we can do research on regulation and what is the right balance in helping states understand.  This is uncharted territory in a health services kind of context.  Dean?

          DR. ORNISH:  I just think it needs to be clear what the role of the federal government is.  I think licensure traditionally has been left to the states.  I think it should be left to the states.  It is not clear in this recommendation whether you are simply saying that they should make guidelines that might be helpful to states or they should make guidelines that states have to adhere to, and I think there is a big difference.

          DR. FINS:  I would say that the federal government, in the interest of addressing what we say up on No. 5 above, inconsistent licensing across the states, which may present a significant risk for consumers, assist the states in coming together and developing regulatory mechanisms.  This is an area that we do not understand all that well.  Jim?

          DR. GORDON:  Well, the recommendation is kind of cumbersome.  If you could define where it is coming from.  Are you saying, let's look at the Minnesota Model and let's see how it is doing, or are you saying something -- I am not sure what you are saying in the recommendation.

          DR. FINS:  I am saying that states design an outcomes-based, or whoever would want to study this, an outcomes-based approach to this relationship between competency-based regulation, which if you demonstrate the competency and you have the legal authority to practice, what are the implications for the public health, for adverse events, et cetera, et cetera, and get a sense of whether or not the balance between regulation or access is appropriate.

          DR. GORDON:  It sounds so theoretical.

          DR. ORNISH:  I mean, it is unclear to me again whether you are saying that the states should be basically setting national regulations for licensure or just helping the states determine their own, because already there is state-to-state variability.  You said something a moment ago that made it sound like that was a problem, but I think that is part of the strength of it.

          DR. FINS:  It is, but we don't know, I don't think, in a systematic way, what the heterogeneity of regulatory approaches means for the public health.  If it is too big, we can delete it.

          DR. GORDON:  I have a better idea of what you are saying.  Why not say, let's look at what the states have done, let's look at the models that are in place now, and we don't have to set up anything, all we have to do is get the information from those models, perhaps back to CAM central, and let's see what is going on.  I mean, that is kind of my sense of what you are getting at.

          MS. LARSON:  So your request for clarity and a little change of focus for the project.  We will take that back to the committee.

          Michele wanted to do a clarification.

          MS. CHANG:  I am beginning definitely to see the wisdom of Tom's suggestion that we do reference the Pew recommendations when we follow up with these further clarifications or expansions of the recommendations that they made.  Several of the ones we just went through had that difficulty because they directly resulted from recommendations that were made by Pew.  So, that is one thing, I think we can do that and that will help clarify.

          The second is that I think our experience has been that the states are very receptive to guidance from the federal government.  They like to receive guidelines.  They find it difficult to have to try to do that themselves because of the variability issue and other issues, budget issues, et cetera, but this is an appropriate and welcome input from the federal government, and that was a little bit along the lines of what we were going towards.

          So, in answer to Dean's question, yes, we would be asking the federal government to provide clear guidance to states, based on what states are doing themselves that they don't have to do it themselves, and that is actually the intent of most of the recommendations here.

          DR. FINS:  Not to usurp the authority of the state, but to help the federal government catalyze the discussion.

          MS. CHANG:  Right.

          MS. LARSON:  Joe and then George, then we have got to move on.

          DR. PIZZORNO:  Despite the earlier flippant response, I actually think this is an excellent idea, because what we are trying to do is recognize that so  much of the regulatory process right now is politics-based, politically based.  We are trying to make it more evidence-based.  I think the more we can make it evidence-based, the more we are going to be able to contribute to the public health, and this is one way of doing that, by gathering good data and providing that as guidance and assistance to the states.

          MS. LARSON:  George DeVries.

          MR. DEVRIES:  Just as a reminder for those of us on the committee, when we first started talking about this, the concept really was to say that the CAM providers each have a certain scope of practice and education, and that education and scope of practice sometimes, not always but sometimes, allows them to examine, diagnose, treat a condition and, therefore, we believe and we are recommending that the states grant the appropriate legal authority, whether that is licensure, registration, certification, or otherwise, to those practitioners to be able to operate within the scope of their education and their scope of practice.

          So, when it really comes down to it, we have broadened our discussion in terms of how we have defined licensure and have discussed this issue, but ultimately it came back to saying, how was the provider educated, what is their scope of practice, what does that mean they should be able to do, therefore, it is our recommendation to the state to allow them to do that and give them the legal authority to do it.  That really kind of comes down, I think, to the bottom line.

          DR. FINS:  And then this recommendation is to evaluate that change in any state law, to see what its impact is.  It is not theoretical, Jim, because it is really the protect the public safety if you had an adverse event, adverse outcome, or if there is value added.  So it is a demonstration project in either direction, because it does represent a change.

          DR. GORDON:  What I would say is that this is now clear to me, it is a separate recommendation, I think.  There is a whole issue -- and, George, thank you, I really appreciate what you said -- that we have heard over and over again.  I remember hearing it from nurses, well, if I do therapeutic touch, is that part of my nursing scope of practice or is that something different.  I think we need a very specific recommendation, and I would make this recommendation to you, regarding scopes of practice, because this is an issue that came up again and again and again.  Then following up that with some feedback about evaluation of how it works.

          I just see that as different and a more focused recommendation than the way 41 reads right now, because one is talking about state programs in general in dealing with CAM professions, the other has very specifically to do with scopes of practice as an issue that affects many different professions.

          MS. LARSON:  I can assure you that we will discuss it.  I know for myself that I do not have enough information available to me to talk about scopes of practice, but we will bring it back to the workgroup.

          No. 42 and 43 are actually put here, as our excellent staff member has said, as placeholders.  I would actually like her to speak to that issue a little bit, and Joe.

          MS. CHANG:  Yes, we want to be sure to acknowledge that we have heard a lot of testimony and concern from the Commissioners, as well, about the interaction of state medical boards and CAM practitioners.  We will be addressing that in further discussions between now and December.  We will have, hopefully, a couple of recommendations to address those concerns; however, as Gerri referenced in her section, we are still waiting for some critical background information on this issue from the Federation of State Medical Boards.  That is about all I can say about that right now, but I just want to assure the Commission that this issue has not dropped off our radar, but we are not prepared to discuss it at this point.

          MS. LARSON:  Jim.

          DR. GORDON:  Michele, what you are saying is one issue has to do with disciplinary issues, broadly speaking, but it seems like there are other issues, as well, that you are thinking of in here?

          MS. CHANG:  We didn't even want to do a background piece on this, because we did not want to misrepresent the issues, and we felt that the information that was missing was too critical to go forward.  So we made the strategic decision to wait until we have that information.

          DR. GORDON:  But the disciplinary issue is one of them?

          MS. CHANG:  Oh, absolutely.

          DR. GORDON:  Okay, good.

          DR. JONAS:  May I suggest that this general approach, not exactly what you are doing with this waiting, but this interaction with an important body, agency, that is going to deal with one of recommendations here be something that the committee as a whole do in a more systematic way?

          I think there are a number of recommendations in here that have direct implications on a variety of management, regulatory, including federal agency, bodies, and it would be, I think, very nice if we went through those, someone went through those, identified those individuals and then actually approached them about it, and said, here is a draft recommendation we are thinking about in this area, is this something you could give us feedback on, et cetera, which is sort of what is going on here with the State Federation.  I would just like to make that as a general suggestion.

          DR. GORDON:  That seems to me that is a staff function, basically, Michele and Steve and the rest of the staff will look.  That is the plan, isn't it?

          DR. GROFT:  Yes, that has been the idea all along, that after we get recommendations, we would identify who they would be directed to, then we would approach them to have them review and give feedback to us, as far as what they think about it and maybe more appropriate language or language that would be easily implemented a little bit better.  So, our intent is to go back to these various organizations.

          In fact, I mentioned to Jim briefly, we have some correspondence from the National Governors Association that we have to get back with them.  I think we were waiting for the approval of the Interim Progress Report.  Now we can go back to them, and I think we would like to bring all of the various issues that we identify at this meeting to them, and perhaps we can establish a dialogue before we prepare the Final Report.

          DR. JONAS:  I think that is great.

          DR. GORDON:  One thing we can do, Steve, as we come up with those issues, send them out to all the Commissioners, so everybody will have a sense of the directions and the agencies, and so if there is any input from anybody about who we should be talking to regarding those issues, that input can come in.

          MS. CHANG:  Can I just mention that that will happen naturally through the workgroup process as it currently is.

          DR. GROFT:  So that each workgroup will have it.

          MS. CHANG:  Yes, I think that as the contacts are relevant to the workgroups, we will do it probably that way.

          DR. GROFT:  We will do a better job of communicating with the Commission members to identify the correspondence that goes out and it comes back, the meetings that we are planning to hold, the teleconference meetings, so anyone who would like to participate will have access to the times and places.

          DR. FINS:  Let's move on now to page 17, which is the next group of recommendations.  What these sort of cluster around are more not the personnel issues that we have just been talking about, how do you regulate practitioners who are part of a workforce and licensure and certification and those kinds of issues, this is now sort of infrastructure issues and delivery system kinds of concerns.

          With that, I will turn it over to Linnea for the recommendation No. 44.

          MS. LARSON:  Do you want me to read it?

          DR. FINS:  Or I can, whatever.

          MS. LARSON:  I thought we were trying to share the podium.

          "The Commission recommends the Secretary of Health and Human Services expand current models of integrative service networks to incorporate safe and effective CAM services as appropriate." 

          I am going to read the next sentence, and say we still have some questions on the next sentence.  "Special attention should be directed to address the needs of vulnerable or underserved populations."

          Open to commentary, please.  No additions?  Discussion?

          DR. WARREN:  Who determines "as appropriate"?

          DR. FINS:  The Secretary.

          DR. WARREN:  With what background?

          MS. LARSON:  So you are asking for the specific mechanism.

          DR. WARREN:  Yes, I am asking the Secretary is going to --

          DR. FINS:  I think it is related to some of the issues that come up in coverage and reimbursement in the next go-round about mechanisms, about what things would be considered for inclusion in packages.  So, I think we can bracket that issue for maybe a little later on.

          It is sort of the interface between the micro-economic and the macro-economic.

          MS. CHANG:  Additionally, I think that we can add some background information contextually, as well as models of integrated service networks that will give you better example of how it currently works, so that it gives you an example of how these things would be added on to that system, which we didn't do.  We can do that.

          DR. GORDON:  I just have a question.  When you say integrated service network, what are you referring to?

          MS. LARSON:  What are they?

          DR. GORDON:  Yes.

          DR. FINS:  It could be a vertically integrated health care system, you know, from a community center, health center, all the way up to a tertiary care medical center or a quatinary medical center.  It is basically trying to look at the infrastructure that exists and how those entities work well together and create a seamless continuum of care.  Medical care is, though we like to fancy it, is not practiced in an individual office, it is practiced with a whole mix and panel of individuals.  What we are trying to do is understand that better and understand the mechanisms in this section of how to integrate CAM into delivery, into integrated delivery systems.

          DR. GORDON:  Is there more guidance you should be giving?  I am really asking that, it is not a rhetorical question, it is a real question.  Does it serve us to give more guidance, because the Secretary is going to do what, getting this recommendation, is what I would like to know?

          MS. LARSON:  Julia?

          MS. SCOTT:  I own up to the fact that I was on this committee.  It is a very good committee, but I have a certain level of frustration because there was not the time to give to this.  This is a big issue, access and delivery.  In my more than 35 years working in the area of health, and in particular in women's health and African-American and people of colors' health, the issues having to do with special populations, vulnerable and underserved, somehow never get the kind of attention that is needed, especially when you put it in the context of developing policy recommendations.  We somehow get further constrained with trying to be political and trying not to be too radical, and this is one area where I really think we need to try to step out of the box on.

          I've been on too many committees looking at the underserved, and I do think we need to be very prescriptive here and very specific and even a little bold, because our health care system has not addressed this issue well at all.  I think we have an opportunity here, and I would like to specifically ask that our committee, as we go back, really try to be much more specific here on a recommendation that would really and strongly address access to vulnerable and underserved populations.

          MS. LARSON:  I am very grateful that you have said that.  You and I have discussed it earlier.  We will put that on the agenda.  I want to move to Wayne.

          DR. JONAS:  I am going to go a little step further than that, actually.  I think that this section doesn't at all communicate the importance of special populations, underserved populations.  Originally when we proposed this Commission itself, we actually had that as a subsection, one of the tasks.  Now that got subsumed under Access and Delivery.  We have to separate it out from Access and Delivery.

          Rather than focus so much on the Pew Report, which I think is important and we should have in there, we should also connect this to some of the tremendous other things that have been done on health disparities and closing the gap and that type of thing and really put that in here as one of the anchoring areas that we are relating to and our recommendations are relating to, and then have specific recommendations in here that address those.

          MS. LARSON:  Thanks.  Conchita.

          DR. PAZ:  One of the things I think, as far as this No. 44, is to cross out where it says "effective CAM services as appropriate."  I would just cross out "as appropriate," because I think that is too nebulous, and I think we just need to state that it needs to just incorporate it.

          MS. LARSON:  Dean.

          DR. ORNISH:  I think it might actually strengthen the case that you both are making if we can talk about how CAM modalities may be, in many cases, more cost effective, and therefore it increases the access.

          For example, over 90 percent of bypass surgery was done in white, upper-middle class men last year.  They are certainly not the only people who get heart disease.  In fact, it is declining in that group and rising in underserved groups.  Now with the recession coming, more people are going to lose their health insurance because they are going to become unemployed, which means we will have more than 50 million uninsured.

          So, I think that one of the only ways that we can address these issues is to highlight how one of the advantages of CAM is that they can make health, real health care, available to a larger group of people, particularly underserved, that we simply can't afford to do otherwise.

          DR. FINS:  This sort of reminds me of the conversation some of us had with Steve, early on, about whether or not access and delivery, and coverage and reimbursement should be a single group or not, because a lot of the issues about the cost-benefit analysis, and showing that some CAM modalities might actually be more cost effective or value-added is addressed in the next section.

          I think what we were trying to do here, and I agree that maybe we didn't realize its full potential, was to look at and try to understand the infrastructure that would support delivery of those modalities, or the access to those practitioners who we have just dealt with that are going to be regulated in various ways.

          I think what we saw down at Beth Israel Hospital in New York City or at the King County Clinics, and the relationship with Bastyr and the University of Washington, we are trying to capture in this section a mechanism for the federal government to help, perhaps, stimulate and understand the delivery of an integrated model of care, beyond isolated, sporadic practitioners, and how would they all work together.  That is sort of what we are trying to capture here.  So, that was our intent.

          Jim?

          DR. GORDON:  I am really glad to see the recommendations and hear the discussion.  For me, this can be one of the most powerful parts of the Report, and I think the more specificity we have -- I see this at every stage of the life cycle -- that there is enough evidence to recommend that there be doulas in every hospital for childbirth, there is enough evidence to recommend infant massage, there is enough evidence to recommend serious education about nutrition in all pediatric clinics, work with stress management for all chronic illness.

          I think we can really take all the things that we have.  We know the evidence, we have had the evidence presented.  All of these approaches can be integrated at every aspect of health care for the whole population.

          We talked previously about a vision statement.  There was some discussion that I might do a vision piece that I would bring back based on this meeting, and that we would then talk about next time.  That is fine, but I think that much of the vision is embodied in Access and Delivery: what would we like to see for everybody in the United States; what would we like to see available; what do we know based on the evidence that we have had presented to us.

          MS. LARSON:  I want to make a comment.  I do appreciate that, and I would actually couple that with the information that Wayne provided, as using the already-existing material that we do have, and research, and also linking it to what Dean said in cost benefit.  Those are the three things.

          We are quite well aware, I don't think that we have done enough with respect to uninsured populations.  However, I think that our mandate to is to be very specific about the complementary and alterative medicine as it applies to the delivery of service.

          DR. ORNISH:  Just a follow-up.  I think the two other implications of highlighting this, one of which ties into what we were talking about yesterday about defining the terms of the debate in a way that marginalizes opposition.  If you say, we are in favor of helping people who are underserved and who don't have much money, and who need the help, and here is one way that we can do that that is innovative, that forces people to say, well, we are really not in favor of that.

          The other is, that so often CAM is associated with elitist, upper-middle class, wealthy people who pay out of pocket.  The studies that Eisenberg and others have done that show more money is paid out of pocket is because it is mostly people who can afford to pay it out of pocket.

          By putting it in these terms, it gets away from that both preconception and reality, that often CAM modalities are for people only who can afford them.

          DR. FINS:  I was just told we have 15 minutes left.  Any burning comments?

          Again, I think a lot of these issues are going to be brought up in George's group next, about how we allocate those resources.  What I would just like to ask the Commission for is to send Michele any thoughts about infrastructure-building and integrative models of care, because I think that is an area that, as I see it, is what this section is about versus what the next section is about.

          Joe, did you want to say something?

          DR. PIZZORNO:  This is a fascinating conversation.  And, Julia, I particularly appreciated your comments.  I did not understand how that would relate to specific language that we should be including in No. 44.

          Could you give us a couple of sentences that you would like us to think about, as this committee works with this?

          MS. SCOTT:  I really want the committee to discuss this, to have a full discussion on this.  Really, I want to push the committee to be bold in this area.  I am sensitive to something being cost effective and all the policy do's and don't's when you are putting a recommendation together.

          I think there are a couple of places in this document where we have to be bold, and perhaps making a recommendation that may not initially be cost effective but that it is for the good of all of its citizens.

          So, I think we have to be thoughtful about this, and I think people on the committee all have ideas.  I think it is a larger discussion.  I don't have anything off the top of my head.  I just know that I feel we can do a lot better.

          MS. LARSON:  I think it is really important that we need to do much better.  I would appreciate your pointing out the two specific sections, and then really assisting on crafting recommendations that we, as a group, then can discuss.  Thank you.

          DR. FINS:  Recommendation No. 45.

          DR. GORDON:  I just want to say one follow-up on what Julia said that I think is really important.  It is important to talk about cost benefits.  It is also important to talk about what our vision of a health care system informed by the best of CAM would look like, and then we will deal with the cost benefits also.

          DR. FINS:  The vision of my health care system is that we have universal access, and that, of course, is the largest gap, the greatest vulnerability.  Again, I just want to say, to provide people who don't have access to conventional health care access to a CAM modality that is not proven to be cost effective or value-added, or replace a more expensive modality, is efficaciously troubling.

          DR. GORDON:  I hear your point of view, and this is your committee, but there are also other perspectives that are being articulated strongly.

          DR. FINS:  I hear that.

          Ti, and then we are going to move on.

          DR. LOW DOG:  I am in favor of offering effective treatments, but I just want to come back.  We have got wellness at the end of this whole thing, wellness and self-care.  It is kind of the last afterthought.  Eisenberg says more money is spent out of pocket, and that is because people want to buy pills, and go to the doctor, and go to the acupuncturist, and go to the chiropractor.  Everybody wants to go and have something done to them, when the reality is, in many of the underserved and poor populations what is really needed is better diets, self-care, wellness.

          I think you are going to have to really focus on that, which I think we have come back to, but it is interesting that we shoved it to the end.  After everything else, we have got wellness and self-care.

          I am not sure that just spending more money on other services is really the answer to our health care problems, and I am not sure that we have proven that many of these CAM therapies are really going to be the answer, or that they are effective.

          So, I just want us to be mindful of that when we are making these recommendations.

          DR. FINS:  No. 45, we are going to skip, and cede to the Coverage and Reimbursement group and George.

          No. 46 is that we recommend that there be more detail and epidemiologic information, which I think is hard to disagree with because it will help chart future strategic planning with a special focus on vulnerable populations.

          David?

          DR. BRESLER:  It seems to me that a lot of the issues that we have been discussing are really resolved by good research.  You think of the Barefoot Doctors movement and the large population in China and so forth, and it may well be that CAM offers a lot of benefits to underserved populations.

          I would like to see this one stretched a little bit, maybe in terms of demonstration projects, maybe in terms of more research orientation to really answer these questions that we have just been debating; to what extent would mind-body medicine, for example, help people have better lifestyle issues, and things of that sort, and education in underserved populations be an effective intervention for them.

          A lot of these questions can be answered by good research.  If we want to put some teeth in, let's get some funding to support this type of research for these populations, and let's find out.

          DR. FINS:  Sort of in tandem with the recommendation that Joe Pizzorno made earlier about the partnering between the naturopathic and allopathic doctor, let's see what that kind of investment does for wellness and prevention and cost, as well.  I mean, there are values and there are cost benefit considerations.

          So, is there anything else on No. 46?

          DR. GORDON:  David, I didn't understand.  Is that in addition to No. 46?  Or, are you saying something about No. 46?

          DR. BRESLER:  Well, basically, as I read it, No. 46 is just asking for surveys to be done about patterns of use.  I am saying we need to answer the questions that we have just posed as to the cost effectiveness, the benefits to these populations, access issues to these kinds of modalities, and so forth.  I would like to see this expanded, not just to be a survey on the pattern of use but answer the questions we have just been debating.

          DR. FINS:  For this particular part of the story, I think it is really not particularly studying a modality like acupuncture, but acupuncture, say, in the context of a primary clinic, in the context of a county health care system, what does that do for overall costs.

          So, it is a systems approach.  It is modalities or clusters of modalities within, not a specific study about whether one modality works or not.  It is proven modalities, how do they bring value to structures and systems of care.  That is what we are trying to get at in No. 44, and I think what we will bring back to the group.

          We want to move on to No. 47.  This is concurring with the AAMC report, which suggested strategies to improve medical student education on spirituality, cultural issues, and end-of-life care.  It recommends the federal government establish an institute to address the needs of seriously ill and dying patients, and their families: "The Commission believes that the collaborative integration of many CAM approaches is both appropriate and will add critical value."

          Now, the reason why this is here, other than the fact that I happen to be on this subcommittee and I care a lot about end-of-life care, because it is an experience we are all going to have, right?  As Woody Allen says, "I don't mind dying, as long as I am not there when it happens."

          The reason why this is here is because we think that of all the delivery systems that we have heard about, the place where the diagram really comes together most nicely, where the allopathic and the complementary all come together best is in the context of hospice, the hospice model.

          So, we think there are lessons to be learned.  You can get music therapy, you can get spiritual counseling, you can get visualization, you can get a PCA pump, and you can get radiation therapy, all in hospice.

          So, we think that by a confluence of almost serendipity and a lot of hard work, the people in palliative medicine, that hospice is a model that we need to understand better, and it may be a way of disseminating this integrative approach, which I think we are collectively endorsing.

          Jim?

          DR. GORDON:  I agree that hospice is a very good model.  It is not the only one.  I know it is your passion.  I just realized a couple of days ago that we are all going to die.  I don't have this totally formed, but let me say this.  Sometimes it is a little too easy to focus on hospice.  I think it is sort of like, okay, let's let the chaplains come in at the end of life.  That is sort of the experience.

          Let me just continue.  What about in the middle of life?  What about early in life?  The question is for me, I could say the same thing about care of chronic illness, and I could say the same thing about work I have done with adolescent substance abusers, is that everything comes together in a way that fits.

          I think what we need to do is to use hospice as one model, but essentially to say that there are all these models, all these different stages, all these different times, all these different occasions in which the model comes alive.

          Then the question comes up of what we then recommend.  So that is kind of where I am.  I think we are circling around something, but I don't think it should just be hospice.

          MS. LARSON:  I would like to speak to that.

          DR. FINS:  Please.

          MS. LARSON:  It is a category issue, and it is also an issue about adding on more recommendations that are much more direct for given populations.

          The model of hospice is one model, but the model also is very, very inclusive of every kind of discipline.  There may be mechanisms of delivery that are not as explicit about, we are going to be inclusive of all of these different professions for adolescents, say, or for chronic illness.  There is specificity there.  I just wanted to make that clear.

          Having worked in a hospice and knowing the phenomena of, yes, we are all very nice here; we all do this work; we are dying; et cetera, I know what you are speaking to.  So, you are asking for two things, to expand it, to recognize in background material that this is not simply the only model, and then to say, these kinds of services do apply and have been given to other age groups.

          DR. GORDON:  Thank you, Linnea.  Then there is just one additional thing, and what do we want to have done.  I think that needs to be clear, clearer than it is in Nos. 47 and 48.

          DR. FINS:  The other point that is important, I think, is that most communities have a hospice.  Of all the integrative modalities, it is probably the most utilized, and many families are affected by that.  So, in a way, to understand and to disseminate the integrative approach that is holistic, this is a good place to start.

          DR. JONAS:  I just want to echo, I guess, and agree with Jim's point that we need to expand it beyond that, because when the hospice individuals were here, I think I asked them specifically how many CAM modalities are incorporated into the practice, and what I thought I heard was actually not that many, that the opportunity was there, but they didn't actually use many CAM modalities in an official way.

          So, it was an opportunity, it was a place where it could certainly have a lot of payoff and benefit, but it wasn't any particularly greater percentage in hospice than it was in many other places in regular care.  I think it is useful, but I don't know if it is actually a model that we could point to and say, aha, here is where integrative care is actually going on in the way we would like to see it.

          MS. LARSON:  I am of two minds here, and I do need to speak to that.  It is actually true, having been in a hospice, but the specific requests were to expand the CHMB, to have more particulars in the naming of certain disciplines within that model for CAM practice.

          DR. JONAS:  What I heard was not that they were asking to expand it into CAM practices, they were asking to expand the hospice approach to non end-of-life care.  In other words, to do it earlier and this type of thing.

           So, it wasn't particular to complementary medicine, per se.  That is what I heard about it: start it earlier; this is great care; we really talk about holistic care; we are really trying to nurture and care; we talk about care rather than cure; let's start doing that earlier than by the time people are ready to die.

          That is what I understood they were asking for, primarily.

          DR. GORDON:  We actually can give you some more time.  So, let's take 15 more minutes at this point now, if you would like some more time.  Are we addressing both Nos. 47 and 48?  I feel we are.

          So, please continue for the next 15 minutes, whether you want to talk more about this, or talk about No. 49.  How you would like to use the time?

          DR. FINS:  I think that another way of really addressing this is that people who are at the end of their life, and there is sort of an artificial categorization, there is a six-month Medicare hospice benefit, but people could be dying for longer periods of time if they have, say, a progressive dementia or something of that sort.  People have said that that Medicare hospice benefit -- we heard testimony -- should be changed.

          It is beyond the scope of our work here, but I think this is a vulnerable population that does make use of CAM modalities, has a tremendous amount of hopefulness that may lend itself to utilization of CAM modalities.

          It is an entity that is dispersed throughout the country, and there has been a lot of progress in end-of-life care.  I think that we are talking about collaboration and piggybacking onto reports.  There may be a synergism of piggybacking onto another movement, because I think the ethos of the hospice movement and the palliative care movement is constant with many of the elements of the CAM movement.

          I think that there are real synergisms here, and maybe we need to flesh out, in a more discrete way, how those things could be leveraged together.  We may not have it right in Nos. 47 and 48, but I would like to get a sense of whether or not the group thinks it is a productive vehicle to explore further, perhaps with some editorial, substantive revisions.

          DR. BRESLER:  Again, following up on Wayne's comments, it seems to me that this is another issue that can be resolved by research, and that the Commission could make recommendations of some demonstration-type projects where we do meet their request to bring CAM into the hospice movement, take a real good look at it as a model for integration, and then see what we learn from that and be able to expand it into other models.

          This is something with a little more teeth in it, again, that we can make very specific recommendations to support.

          MS. LARSON:  Thanks.

          DR. JONAS:  I would echo that.  I think that would be a good approach.  I would also say another way to emphasize it would be if we pull out and emphasize the whole area of vulnerable populations.  Then this could be one of a few, not a huge laundry list, but of a few where you say, here are some that we think are especially ripe for looking at integration issues.

          MS. LARSON:  Then have the appropriate background material to substantiate the use of those populations for research.

          DR. JONAS:  Exactly.

          DR. GORDON:  I also think this is one of those places where our 10 basic principles come in.  One of the reasons that we see hospice as a model is because it fulfills many of those principles, but so do other programs.

          I think that this comes back to the point that Charlotte was making earlier, that this is where we have the drama and the power.  I think we need to convey what it is about hospice, what it is about some of these others, whether it is ARRE, which you all heard about, which I work with, where they are really looking at whole people, people are definitely underserved.  They are HIV-positive addicts, most of whom have done time recently, but they are also empowering them, they are giving them choices, they are giving them support, and peer support, and a healing community.

          I think what we need to do is to get, in a sense, more imaginative with our examples and to explain how this relates to the basic principles of CAM, and how each of these different models, of which hospice is one, but for me just one of a number, can really inform all of health care, and how each of them can be a place where CAM comes in and makes a major contribution.

          MS. CHANG:  I just want to add, also, I want to refer folks back to a quick review of the Report, of the Medical School Objectives Projects, because it also identified issues around spirituality and cultural relevance in this model, and I think that that also spoke to us.

          I know that we will be revisiting hospice as a model in the Wellness section, I believe, but we have brought this up a couple of times to more explicitly address issues of spirituality and culture relevance in health care.  I think that was one of the things that really appealed to this workgroup about hospice.

          So, just a note.

          MS. LARSON:  Ti?

          DR. LOW DOG:  It is off the track, but I just wanted to know if somewhere in there under Access, we could talk about access to products, protecting people's rights to have access to products.  We need to remember that half of all the money that is spent on CAM right now is in product, and the fact that on your formulary, you may be able to get Hytrin, but you can't get saw palmetto.

          When we are talking about access and delivery, if you pay $2 for your Hytrin, but you have got to go down to the health food store and pay $30 for a product that also works, it is limiting.

          I just didn't know, since most of this was on service.  This is access.

          MS. LARSON:  Ti, can we put that for Saturday to continue and have that on the table?

          DR. LOW DOG:  Okay.

          DR. GORDON:  Since Ken is going to the board, this must be a new issue, and this is one of the ones that we can come back to a bit on Saturday morning.  It is a huge one.

          I have one more new issue I wanted to bring up.  We are going to go to No. 49 first.  The new issue is something that was mentioned under Education and Training, but I think it fits better here, which is the whole issue of navigators, of educators, of people in the community who help community members find the right path for access, help them make the decisions that they need to make.

          I don't think we heard it here.  Harold Freeman had a very interesting example at Harlem Hospital of navigators to help women with breast cancer to make decisions.  I have done a lot of work in this area.  I just want to put this up as a new area that I think could be important.  I bring it up here under Access because it is designed to help people find better access.  I think it fits here better than under Education and Training.

          MS. LARSON:  Joe.

          DR. PIZZORNO:  I am going to do something I am a little uncomfortable with, but I have to do it because I feel strongly.  At our last meeting, unfortunately, I had to leave an hour early, and I didn't realize there was such a dramatic difference between what I thought was the committee report and what ended up in this folder.  So I am just going to bring it up, because I think important things were left out.

          In our committee report, Nos. 42, 43, 44 and 45 were cut out, and I don't understand why.  No. 42 was the recommendation that we have: "The Commission recommends the Secretary of Health and Human Services fund model community-based initiatives through the appropriate regional offices to integrate CAM and conventional health services, especially in underserved and vulnerable communities.

          "The Commission supports demonstration projects and strategic planning to integrate CAM and conventional health services with emphasis on public and community health," et cetera.

          What happened to the demonstration project?

          MS. CHANG:  I don't know.

          DR. PIZZORNO:  This is the last committee report that I had, and there are four recommendations that are just gone.

          MS. CHANG:  I am trying to remember, and I don't, unfortunately, have that report with me with my notes on it.  We did go through staff and internal review to try to reduce the redundancy in some of the recommendations, and I think that was part of the problem that we had.

          Also, I believe that we thought that the integrated service networks, one was a more useful way to incorporate some of the CAM services into the public health systems, I believe.  I would have to go back and check my notes.

          DR. FINS:  But, Joe, given what we heard about No. 44, and how it was a little too vague, it might be better to go back to what we originally did, which was more specific.

          DR. PIZZORNO:  Okay.

          DR. FINS:  Maybe could we just take a moment to read through them real quickly, so that people could hear about it but not discuss it, and we will get e-mail comments or something.  Is that okay?

          DR. PIZZORNO:  So you want me to just read them.  Is that what you are saying?

          DR. FINS:  Yes.

          DR. GORDON:  Let me just say, we can take a moment, but I think the full discussion is going to have to go back to your committee, because there is just no time to do it justice.

          DR. PIZZORNO:  I think that is a good point, because I think a lot of these things are examples of how to do this, that I think certain people, particularly like Julia that want us to do this, for example, the demonstration in community health centers was something I thought we had really clear.

          DR. FINS:  There was no disagreement on the subcommittee about that.

          DR. PIZZORNO:  I think it got lost somehow.

          DR. FINS:  Yes, it got lost.

          DR. PIZZORNO:  Quickly, the four, I will just summarize them.  The second one was an interdisciplinary workgroup: "The Commission recommends the Secretary of Health and Human Service establish an interdisciplinary workgroup for decisions, assessment, implementation of CAM integration in a manner consistent with and in collaboration with Health People 2010 goals."

          The next one is: "The Commission strongly supports the inclusion of appropriate CAM services in military treatment centers, public health clinics and facilities, and in state and local community health centers."

          The next one is: "The Commission recommends that HCFA examine a proposal to enable services for qualified CAM practitioners in all states to be paid under its programs.  For example, Medicare/Medicaid Wellness Act and the Medicare Medical Nutrition Act provide the sole right to have nutrition services reimbursed by registered dieticians." 

          MS. CHANG:  That is actually in here.  We were referring that one to the next committee.  The first one you read, I believe we took it out because it was redundant of one that appears in Wellness.  When the staff went through the entire thing, we tried to reduce redundancy in recommendations in separate sections.  So I believe that one will appear in Wellness.

          The military institutions, I believe we had an internal staff discussion, which I will refer back to the committee on this issue, but there were some concerns regarding needing to talk to the Department of Defense before we made a recommendation that directed their service delivery.

          DR. PIZZORNO:  Thank you for the explanation.  So I guess the recourse I have is, when we have our committee conference call, if you could tell us how these were dispersed into other areas, I would feel much better about that.

          MS. CHANG:  I think we can.

          DR. FINS:  I think for the future, it would be very helpful just to list them and know that they were referred, so that we know that they are being taken care of.  Ultimately, we don't care where they are, but just so we can keep track of their dispersal.

          MR. CHAPPELL:  Did the committee discuss any way in which this would relate to private enterprises, experiments, entrepreneurial experiences of setting up integrated service networks?

          We have had people present.  Whether it was a region that was doing it, or whether it was a privately funded model, any discussion of whether our policies ought to be making suggestions to lower risk so that people are more willing to try these models?

          MS. LARSON:  We did have discussion around models and using them in the text, such as on a continuum.  So we have well space, we have all of those different service delivery models, but I do not believe that we had major discussion of making a recommendation that would include a private --

          MR. CHAPPELL:  Would you give thought to that for me?  I would appreciate it.  I mean, they are taking the same risk, but they are doing it all on their own.

          MS. LARSON:  I believe that that came, as we did not know how much we could go in making a suggestion to private groups, rather than, maybe, a public/private partnership, and we were basically looking at our recommendations at the federal level.

          We have one left.  I am going to read it quickly.  No. 49: "The Commission recommends that the Secretary of Health and Human Services report within three years on the use of indigenous healing traditions in the United States to identify common use, best practices and challenges, and potential areas for collaborative learning between such traditions and conventional care.

          "The Commission urges the Secretary's report to include recommendations for the future as regards appropriate protection of such traditions, as well as research and development of such practices as part of community-based health care."

          DR. GORDON:  I like it.  It looks like a really good, interesting recommendation.  The only thing is, just that whatever the review is, that it include members of those traditions in the process, which I am sure it would.  I just think we have to make that point strongly.

          DR. FINS:  So, I think we are ready, Jim, for your summary, or not.

          DR. GORDON:  Don.

          DR. WARREN:  Are we trying, in this section, to link licensure, or the potential licensure, with access and delivery.  By saying that licensure would increase access and delivery, which I don't believe it will, what are we trying to do with that?

          MS. LARSON:  I think that in my framing, and this isn't just me, this is what we struggled with, is the notion of regulation, regulation and legal authority, which then leads to licensure.  So that is why I put it front and center for discussion.

          I do not know if licensure necessarily will always create better access, but that is our working hypothesis, and we actually did that to have further exploration within coverage and reimbursement, because we have been told over and over again in testimony we want coverage for these services.  There is increasing coverage and the payers or the companies will not pay, reimburse, unless people have the right credentials and licenses.

          DR. WARREN:  You gave us varying degrees of certification or approvals.

          DR. FINS:  George can speak to this.

          MR. DEVRIES:  May I make a comment, real quickly?  I think there are two issues here regarding licensure.  One is, it is an issue of reimbursement and payer requirements related to licensure, or the appropriate legal authority to practice their profession.  Payers tend to tie reimbursement to licensure, but that should really be uncoupled from the access and delivery issue, the access and delivery issue being a different issue.

          I think that this group has done a nice job.  I think stratifying the different types of practitioners and the potential, shall we say, types of providers, types of regulatory requirements that they may have, or licensure or certification or registration requirements that they might have, in order to be able to practice within their scope of practice, because, again, some scope of practices, whether you are reimbursed or cash pay, if you are examining a patient, if you are making a diagnosis, if you are treating a condition, you are practicing a certain level of health care that does require legal authority to do that.  It doesn't matter whether you are being reimbursed under a third-party system, or if it is self-pay by an individual patient.

          So, there probably are slightly different issues for access and delivery, but it lies around scope of practice, the legal authority to practice their profession and be able to operate within their education and their scope of practice.  Again, there are some provider groups where licensure is not necessary to practice their profession.

          Does that make sense?

          DR. WARREN:  But it is necessary for reimbursement.

          MR. DEVRIES:  Yes.  For the most part, yes.

          DR. WARREN:  So, basically licensure is so that we can have our own little handshakes and our own little language that nobody else can understand.  Therefore, the patient suffers because this group won't refer to the next group because they don't understand what they provide, and that group won't be referred to the next group because of professional prejudices.

          MR. DEVRIES:  Well, I think that that assumes there are barriers that can't be overcome through education of the different provider groups.

          I believe, ultimately, licensure provides credibility to a provider group, and therefore enhances the opportunity for the referral process to work between providers.

          DR. WARREN:  Certification.

          MR. DEVRIES:  Well, certification or registration or licensure, whatever is the appropriate.

          Part of it is competency, but part of it is the legal authority to practice within that state.  There are several overlapping issues here, but the bottom line is legal authority to do what they are doing.

          DR. GORDON:  This is interesting and an important issue, and I think this is revealing something that is still unresolved in terms of this whole area.

          What I would like to do is to go through what we have here, and maybe, Don, this means that you need to interact where licensure is being used as the criteria.  Maybe more discussion needs to go on between you and George, as well as Linnea and Joe, and the other members of the committee, about how this needs to work.  I think we still have not resolved all the issues of certification, licensure, registration, that that is very much in the background here.  The more clarity we can get, the better, I think.

          DR. FINS:  It is in the background.  It is not our decision to come down on one side or the other, really.  One state might decide to be more libertarian than another, and what we just simply tried to do is provide a set of parameters that they would take under consideration, because I don't think we can resolve this question.  It is not our prerogative to resolve it at the federal level.

          DR. GORDON:  No, I understand.  Whether or not we resolve it, there needs to be some statement and clarification of the issues, and what some of the concerns are on all sides.

          Do you understand what I am saying?

          MS. LARSON:  I understand, but I do believe that that was addressed in this actual document.  I will go over it once again, but I do not believe it was the intent to stifle people.

          DR. GORDON:  No, Linnea, that is not what I was saying, and that is not what I feel.  I think there is an issue that people have in terms of understanding certification, licensure, some of the issues that you raised in the taxonomy of the Minnesota Model.

          MS. LARSON:  You are speaking specifically of the taxonomy.

          DR. GORDON:  Yes.

          MS. LARSON:  Yes, we have a taxonomy.  We also do have pretty clear definitions of what is universally understood as licensure, certification, registration.  Those are clearly defined in this particular document.  In terms of conversation, I think that we can enhance our work through more conversation so everybody can understand what we are talking about, but, indeed, in the document it is laid out.

          DR. GORDON:  Let me just go through what I have heard so far here.  Essentially, in Recommendation No. 38, there is an appreciation of the value of the Pew Commission Report and a sense that some of the specifics of that report need to be spelled out.

          When it comes to No. 39, there is a lot of question and discussion about the evolution of practice, and the committee said that they would go over the four stages, or the four aspects, of evolution that they described and would refine that and, instead of giving single examples, give multiple examples and give a feeling for the different categories, a kind of broader feeling for the different categories.

          I think there is still a kind of wrestling with this area that needs to be done, based on the discussion, in terms of recommendations about sort of the steps toward licensure.  I think, incidentally, that this is partly where Don's comment comes in, is licensure the only route, and what about certification may need to be addressed -- I am sort of interpolating this -- may need to be addressed somewhere in the recommendations.  Just a thought.

          No. 40.  The two sentences were put together and there was general agreement that No. 40 made sense and should go forward as restated.

          No. 41.  I think that we teased out the fact that there may well be two related but somewhat separate issues.  One, specifically, is on the issue of scope of practice and some of the concerns that are arising as CAM is integrated, or not integrated, into different scopes of practice.

          The other issue has to do, in general, with whether or not to make suggestions -- and, Joe and Linnea, correct me if I am wrong on this -- should there be some kind of suggestion, some kind of guideline for evaluating the regulatory mechanisms that are in place.

          DR. FINS:  I want to say, again, we are not saying there should be suggestions.  What we are saying is the federal government should help catalyze a discussion, not to impose a direction, but to evaluate the risks and benefits of where you draw the lines, raising Don's question, all the way to a much more regulated stance.  What is the best approach, with outcomes based on demonstration projects and assessment of the data.

          DR. GORDON:  Does that make sense to everybody, as stated by Joe just now?  Okay.

          No. 44.  I think this actually applies from Nos. 44 through 48.  There is more of a sense that the statements need to be stronger.  They need to be broader in terms of looking at different aspects of integrative systems, what the actual implications are, particularly for underserved populations and populations at risk, and that there are a number of examples of service that can be referred to.

          In those examples -- and I think there was a general agreement to this -- that the examples give us an opportunity both to illustrate integrative and comprehensive services, and also to illustrate the principles, the sort of enlivening principles of the Commission, and that we can relate the examples to our principles, as well as to integrative care and to integrative service networks.

          Joe Pizzorno, particularly, requested addressing some of the issues that had been in a previous document.  So I think we need to be clear, have we indeed, in this document, addressed all those issues.  Or, as Michele said, are they adequately addressed elsewhere.  This may have to do, to some degree, with looking at some of the relationships.

          A larger issue that was raised, I think, that goes back to this group, is what about the whole issues of wellness, health promotion, self-care, how much of that needs to come in.  There was a pretty strong feeling that there needs to be, even though that is being treated as a separate area, that needs to be very much integrated into some of the recommendations that are being made here.

          Does that make sense, Joe?  Are you with me on that?

          DR. FINS:  I think there is a micro-economic and a macro-economic distinction that needs to be made and issues of individual wellness, individual navigation, I think it is more an education or empowerment kind of area and not really in the infrastructure.  The infrastructure shouldn't impede it, it should seek to encourage it.

          I think that one of the things that I think we do have to do is to say, if someone is navigating the system that there is a continuum of care that is available to them, the panoply of services are available, and that providers from one domain can access the other.  That, I think, is what this is about.

          DR. GORDON:  I think the other piece that I heard, not just from me but from several other people, is that the whole domain of self-care needs to be part of the integrative care system, that mostly when we refer to integrative care systems, it is what professionals do to or for people.

          I heard from several people, from Julia, and from Joe and others, and from Tieraona, that it also has to do with teaching people basics of self-care, of nutrition, that that is part of what people want access to.

          Is that what everybody else was hearing as part of it?  Yes?  Okay.

          Those really apply to Nos. 44, 46, 47, 48.  No. 45, we are going to discuss and take up when it comes to the issues of cost benefits and payment mechanisms.

          No. 49 is accepted as is, with the understanding that people who represent the indigenous healing traditions will be a part of this evaluation.  Then there were two additional issues, which may or may not fit into access but are being brought up in the context of access, one of which is the one that I was discussing in terms of navigators or educators, which may be part of another area, but I brought it up in this context.

          The other, Tieraona brought up, access to products, as well as access to services.  We have to decide, when we talk about it on Saturday morning, whether that is appropriate here, or whether that is appropriate somewhere else.

          Anything, Linnea or Joe, that I missed -- or anyone else -- that wasn't addressed?

          MS. LARSON:  I don't believe so.  I would actually just like to express my appreciation to all Commission members who have given some thought and some excellent advice, and I would really appreciate having their written suggestions.

          DR. GORDON:  Thank you.  Thank you both.  I want to thank you, particularly for all the effort, and for all the background information and some of the supporting documents.

          Thank you, Michele, too, for helping to shape this.

          [Applause.]

          DR. :  We are going to take a break until 11:30.  Then we will come back and George DeVries will begin with looking at payment mechanisms.

          [Recess.]

          DR. GORDON:  Before George begins, Tom brought up the whole issue of doing studies, and looking at the relationship between private practice and access and delivery.  I just want to say that that is a new issue, and either we will be dealing with it here in this context, or we will come back to it Saturday morning.  So, forgive me for omitting that in the discussion.

          George, please go ahead.

          DR. GORDON:  What I would like to have, I would like if you could end at 12:45.  Or, do you need to go to 1:00?

          MR. DEVRIES:  No, we can end at 12:45.

          DR. GORDON:  Perfect.  That would be great, George.

    Session VI: Coverage and Reimbursement for CAM

          MR. DEVRIES:  I want to thank everybody for the opportunity to discuss coverage and reimbursement, in particular, our workgroup members which included Joe Finns and Linnea Larson, Conchita, Dean and  Ming, as well as staff Maureen Miller, who supported our efforts.

          As we get started, what I would like to do is instead of delving into detail right away, I would like to actually do just the opposite.  I would like to go up to 20,000 feet, kind of talk, on a broad basis, what some of the observations were in terms of this workgroup, related to coverage and reimbursement, and really how we went forward with basically making the recommendations we have made, because I think it is important to understand it on, shall we say, sort of a broader level.  Then we can begin to delve into the context of the details.

          The primary issue, probably, related to coverage and reimbursement for this Commission, based on discussions we have had over the last year to year and a half, has really been mandating coverage versus working with the current health care delivery system, the current payer system, to encourage them to provide coverage.  That has always been, I think, the discussion point that we have had.

          Where we came to as a workgroup was down to one primary premise, with others following from it.  The primary premise being those CAM services that are shown to be clinically safe and effective should be covered.  So, basically the recommendation of the Commission is saying that those services -- and we should say products -- those services and products that are shown to be clinically safe and effective should be covered.

          Now, we recognize the challenges of our current health care delivery system and third-party payer system, that there are barriers out there.  There are barriers for having services and products that are clinically safe and effective, to get coverage for them, as well as services that are provided but do not have the research to support clinical safety and efficacy.

          So, as we began to go through our process of making recommendations to this Commission, it was really along those primary assumptions, and then saying, what are the barriers that we as a country, in fact that the CAM industry, faces, but really, all of health care in terms of obtaining coverage and reimbursement.

          First, there is a variety of assumptions, but I would like to run through several assumptions that, basically, we have made.  The current platform, in terms of providing coverage, whether that be health plans, insured coverage, coverage through federal or state programs, that that is fundamentally the system we are operating in.  That is the first assumption we made, how do we work within that system to obtain coverage and reimbursement for CAM services.

          The second assumption that we basically made was we needed to look at the provision of coverage and reimbursement for CAM in the context of the many, many federal and state laws that exist to regulate the coverage and reimbursement of health care services.  That includes both in state insurance and HMO laws.  That includes even IRS statutes related to what an employer can cover as a benefit, a fringe benefit or employee benefit for their employees, even federal ERISA laws, that there are certain guidelines we are working within.

          I think the third assumption is that, again, it is working within the context of our current platform, that maybe over a period of time, a decade or 20 or 30 years, perhaps how benefits are provided for Americans will change, but that is something in the future, that is different than what we have today, again, going forward on the basis of what we currently have.

          Then really bringing us to a fourth assumption, given the current environment, what are the steps that we can take to increase coverage by health plans and employers.  I think the challenges, some of the barriers we face, really, any change, for example, in benefits offered by HCFA literally require an act of Congress.  Congress has passed a number of initiatives related to new benefits, but it has not provided funding.

          So, there is, in a sense, a backup at HCFA, that really it would be literally where Congress not only approves the addition of a benefit for HCFA but approves the funding, and those both are critically important.  That is a challenge, to obtain, especially in our current environment.

          A second barrier is, health plans are hesitant to add coverage for services, especially those that have not been shown to be clinically safe and effective.  There is a perception that they are trying to mitigate the continuing increase in cost of providing health care coverage, and so they hesitate to add anything to especially the basic coverage, the basic plans that would increase costs and might cause some employers not to purchase coverage.

          There is also a lack of information, both for governmental agencies, employers, health plans, regarding CAM services, clinical safety and effectiveness of CAM services and other areas of CAM.

          Finally, I think there is a lack of collaboration between the health plan and insurance industry and the federal and state agencies that provide benefits and generally in the CAM industry.  Therefore we really came up with a series of recommendations.

          I would like to just summarize quickly, we will read the issues as we go through it and look at the recommendations, but specifically if we look at what the recommendations and we say, how would we categorize the recommendations we are making, the first thing is we are suggesting a dramatic increase in collaboration.

          We are not just making another sort of support for more research, but it is really, yes, there is a need for research but there is the real need for collaboration, that the federal payers, state payers, that the health plans, the insurance companies, the employers be part of the collaborative effort to decide the research that is done, to help to fund that research, so they are a stakeholder in this process, that as the results come forward, that there will be a higher likelihood that coverage will be provided.

          I think the second recommendation is, we are obviously going to be supporting an increase in funding for research, both research related to clinical efficacy and safety, as well as research related to comparative health services research.

          No. 3.  It is basically going to be an encouragement to make sure that there is the appropriate legal authority in all states across the country for CAM providers to fully practice under their education and their scope of practice, i.e., licensure, certification, and registration.  This will allow there to optimize the opportunities for coverage and reimbursement and the provision of benefits for CAM.

          Fourth, is to elevate the billing systems and evidence-based criteria on medical necessity to improve the ability of CAM to participate in third-party reimbursement.  And (5), to increase the availability of information to payers, so they can make decisions to cover CAM.

          So, before we really go into the review of the different issues and talk about the recommendations, I would like to invite my fellow committee members to make additional comments on our work.

          Joe, Linnea, Maureen.

          DR. FINS:  I guess what I want to do is, just as an editorial comment, for the relationship between the two groups, there is really a regulation issue, and then there is access, delivery, and health services.

          I think when we put the final thing together, these two sections may need to be deconstructed and reorganized, because I think that dealing with the issues of individuals, clearly, as you were saying earlier, whether or not someone is licensed has implications for reimbursement.

          But independent of the reimbursement question, there is a regulatory piece, and we might want to have a regulation or regulatory section, and then access and delivery, and financing, and service delivery, just to put that on an organization.  I think there is confusion about what is what, and what is access and delivery, and what is regulation.  They are related but they are different.

          DR. GORDON:  George and Joe, with your permission, can we see if people are feeling that way?  Can we give some input to Joe and Linnea and George about this?  Does that makes sense as a way to proceed?  Effie is nodding yes.

          DR. FINS:  Just to have that in mind for after we go through the section.

          DR. GORDON:  Okay.  It sounds like that is a reasonable way to think about proceeding.

          MR. DEVRIES:  Other comments?

          DR. WARREN:  About anything in this session?

          MR. DEVRIES:  No, I was asking the workgroup committee members for additional comments, just from a broad basis in terms of really looking at coverage and reimbursement.

          MS. LARSON:  My only comment is that I remember that we really did work quite a bit on the wording of specific recommendations, and that we really did want to, what George initially said, say clinically safe and effective, that that was a big threshold question.

          MR. DEVRIES:  Thank you, Linnea.

          Any other comments?

          [No response.]

          MR. DeVRIES:  Let's go ahead and start with Issue No. 1, Medical Effectiveness: Fair and impartial consideration of safe, efficacious CAM therapies.

          Issue No. 1 really was primarily dealing with the issue of the recommendation this Commission makes to mandate CAM benefits for inclusion in third-party reimbursement, whether it be under government payers or private payers.  Really, what the recommendation is saying is that if a CAM therapy is shown to be safe and effective, that it should be covered by the health plan, again, regardless of whether it actually reduces cost.

          I think Dr. Ornish, Dean Ornish, pointed out in our workgroup that that is really the criteria that is held for other services, and his encouragement for our workgroup is that that should certainly be the criteria as we look to the coverage and reimbursement of CAM therapies.

          Comments?

          MR. CHAPPELL:  George, then what do you do about the concern for the increasing cost of health care in general, or for the plan?  If safety and efficacy is established, are you assuming that that will be incremental, a benefit that is incremental?

          MR. DEVRIES:  The question of whether this then be automatic for a plan, this is really stated as encouraging, that could be covered, but ultimately, in our reimbursement system, Congress has the final decision related to HCFA and coverage and funding of benefits.

          On the state level Medicaid programs, the states are going to have final authority.  In terms of the states, there may be individually mandated benefits, or, if not, health plans will have determination over coverage.  Employers that are self-funded, or ERISA employers, are certainly going to have the ability to make determinations.

          So, we are really saying as a guiding principle, this is what we believe to be appropriate, recognizing that the challenge of rising costs of providing health care is a very, very real issue for all payers, and they are making difficult decisions.

          Other comments?  Joe first, and then Don.

          DR. FINS:  I think one of the operating assumptions that was implicit, I guess, in a lot of our discussions was that this was in the context of a global budget, whether it is an individual plan or the government, and that we wanted to have mechanisms to show that a new modality was cost-effective or value-added.     So, it is really looking at the allocation of resources that are already in place and demonstrating additional utility.  That also sidesteps, to some extent, the issue of those people who have no access to any health care, because this is really in the context of people who are already under umbrella programs, as well.

          MR. DEVRIES:  Thank you.  Don.

          DR. WARREN:  I don't know if this is the appropriate place, but in your introduction here in the first paragraph on Issue No. 1, the last sentence of that says: "The Commission supports an approach that does not prejudice one philosophy of health care over another, but treats CAM and conventional medicine the same."

          Well, I don't see that being done completely.  We give it lip service, but chiropractic has been proven to be an effective technique, manipulative osteopathy has been proven to be an effective technique, but yet in modern medical practices, those are like the stepchild, they don't ever get recognized.  They don't get used as much as they need to be used.

          Are we recommending as a Commission, then, that they be viewed equally in the payer's mind?

          MR. DEVRIES:  The bottom line is if it is safe and efficacious, we are saying as a Commission that it should be covered, and that is where the workgroup finally came to that recognition.

          However, it is also recognizing the barriers we face in our country, in our health care system.  So as we look at the recommendations, it will talk about how to, we believe, facilitate the process of recognizing, for example, chiropractic, and basically reimbursing it, covering it as a benefit for the safe and effective services.

          Would there be value moving to the next issue?

          DR. GORDON:  I just wanted to ask Don, in raising the question, what are you thinking?

          DR. WARREN:  Let me think about that some more.  Sometimes I just raise questions.  We will see what happens.

          MR. DEVRIES:  David?

          DR. BRESLER:  So, we are making a recommendation that if it is safe and efficacious, it should be covered, and that is the extent of our recommendation?

          MS. MILLER:  If I might jump in here, I think as George has tried to point out, the initial coverage decisions are made by the purchaser, whether it is a federal agency, DOD, or CMS, a state or an employer.  All we are recommending is that they be given equal consideration.  The same way you consider conventional practice that is proven to be safe and efficacious, then that is the way you should also consider CAM services that have been proven to be safe and efficacious.

          They may not cover everything in conventional medicine, and they may not cover everything in CAM.  I'm sorry Dean is not here.  This is a point, I think, he has argued in several groups, which is the fair treatment.

          MR. DEVRIES:  That makes sense.

          Veronica.

          MS. GUTIERREZ:  I would like to respond with, maybe, one answer to the Chairman's question.  I see some real incongruency here when the Commission is saying here that the Commission supports an approach that does not prejudice one philosophy of health care over another, and yet when we talk about Title VII, we have got flagrant discrimination.  I just want to put that on the table.  These prejudices continue, and I will continually challenge them.  Thank you.

          MR. DEVRIES:  Tieraona.

          DR. LOW DOG:  I think that one of the issues here is also, how are you going to determine, and who is going to determine, what is safe and effective.  It is a big issue.

          In one journal, something will say this worked, then there will be a systematic review.  Everybody will say St. John's wort works for this.  Then somebody will do one study, then all of a sudden it shows it doesn't work.  It is a tricky issue, how you develop that when you are talking to people about making these kinds of decisions.

          That is going to be one of the key questions, how are we going to know what is safe and effective.  Some of these things are not products, or an acupuncture, or a particular technique, but we are talking about systems and we are talking about entire professions and bringing them in.  It is a complicated issue, and I just want to know kind of your thoughts on that, George, since this is what you deal with all the time.

          MR. DEVRIES:  You are absolutely right.  It is complicated.  It is difficult.  I think if we begin to look through the draft recommendations, one of the key issues is collaboration, that, as you look at the design of the research and the methodologies, as you look at the funding of the research, that is really where Nos. 50 and 51 go to, which is saying, we are recommending that it is government working in conjunction with private foundations, private organizations, working with health plans, working with provider associations, to help develop the research methodology, to fund the research, to have, basically, multiple stakeholders in the process, so that when there are results that come out on the other end, that at least some payers will recognize them as credible and move forward with coverage.

          It is also the recognize that, as this research comes forward, what is the point of critical mass.  There are people in this room, I think, who understand that issue far better than I do, in terms of how much research is enough to demonstrate that safety and efficacy have been demonstrated, but it is necessary from the standpoint of, I think, demonstrating to the health plans to encourage their coverage.  It is also important for those, if there is a CAM central someday, here in Washington, and they are lobbying Congress for coverage under HCFA, to have these clinical efficacy and safety studies that they can point to and that, perhaps, where the government has participated at some level as a stakeholder in this, will help increase the visibility of those studies and thereby increase the opportunity to, perhaps, have Congress at some point make decisions that will approve not only providing a benefit, but providing funding for that benefit.

          Effie?

          DR. CHOW:  It was related to safety and efficacy, and does that mean, in your first statement, that undergoing scientific investigation, and it automatically is approved for health plan coverage, what happens to those that have not been researched under scientific rigor and that there has been by collection of results, outcomes, that it is effective?  So I am, I guess, kind of reiterating the importance and the complexity of that.

          MR. DEVRIES:  I think there are levels, that whether it is a government payer, it is a private payer, it is a health plan or insurance company, there is a good, better, and best levels of credible research and reliable information that they can use to make decisions regarding coverage and reimbursement.  The best is certainly having multiple research studies related to safety and efficacy that meet the scientific rigor that anyone in the organization would expect of it, that is certainly optimal.

          There is probably less optimal levels of research that may be available or information on outcomes or information on patient satisfaction, which may not meet the highest levels of rigor, but, depending on the payer or the health plan, may be enough for them to make a decision in that area.  Again, each organization may make a different decision.

          DR. CHOW:  So, in essence, like Indian healers and the other healers who are using traditional systems that haven't gone through anything, is that an impossibility right now to get funding, or energy medicine or spiritual healing, all of that, because we have been talking about the didactics that can be licensed, that can be proven, what about all those?

          MR. DEVRIES:  Generally, I would say that is a very steep mountain to climb at this point, even to the extent of where you could say some of these services quality as wellness benefits, and the IRS Code has very strict statutes on what can be covered under an employee benefits plan.  Basically, unless it is recommended by a physician or really related to a medical condition, generally, coverage for wellness, as provided by a CAM practitioner, is not considered covered as an employee benefit.

          DR. GORDON:  I am wondering if we can move along.  It is clear there needs to be more discussion about this whole issue of safety and efficacy.  I am not sure that we can accomplish that here.  We have 10 recommendations to go through.  I am just wondering, given the time constraints.

          MR. DEVRIES:  Thank you.  I appreciate that.  Can we go on and start with No. 50 and if there are some of the related questions --

          DR. GORDON:  Yes.  Maybe the questions could come up in the context of the recommendations.

          MR. DEVRIES:  That would be great.  Shall we start with No. 50, page 3?

          It primarily is driving off of the collaboration process to have multiple stakeholders involved in developing the methodology and process by which the research will be done related to clinical efficacy and safety.  We are not trying to replicate what the group on research has done, but take kind of a unique perspective on it.

          Comments?  Joe, then Tom.

          DR. PIZZORNO:  I think that is a good recommendation.  In these parentheses where you list different public, private bodies, I think we need to include CAM institutions and CAM professions.

          MR. DEVRIES:  Thank you.  Good recommendation.  Tom.

          MR. CHAPPELL:  I am pleased, too, to have this recommendation.  I am seeking some clarity around what you mean by a research plan.  Are you saying sort of a partnership plan of why you exist and what it will encompass, and it will encompass CAM research, demonstrations?

          I am not sure whether methodologies, data, priorities are as clear for me as I would like when you speak about a research plan.

          MR. DEVRIES:  Maybe we can make that clearer, but I think you are absolutely on the right track, which is, it is creating a plan about what are the areas, the modalities, the providers.  It is the methodology that is going to be used, how the data is going to be collected, how it is going to be calculated, such that all the stakeholders, from the beginning, are saying, this is what we are going to do, this is how we are going to do it, and therefore they have buy-in to the whole process so that when the results come, there is buy-in from the front end.

          MR. CHAPPELL:  Thank you.  So, on the question of the threshold of safety and efficacy, you are making the statement of clinical safety and efficacy?

          MR. DEVRIES:  Yes.

          MR. CHAPPELL:  That was the word you used in your introduction.  In the public/private body plan, would we be looking for a different word than "clinical," like "outcome-based" evidence?

          DR. FINS:  Joe, along those lines, I think, to answer Tom's question, we might look at bed utilization, we might look at pharmaceutical costs, we might look at prevention, wellness, absenteeism.  It kind of goes with No. 51, as well.  If you were to have a system in place, what is the impact of this integrated system on the well-being and the disease status of the population under study.

          It is kind of like the Framingham study for cholesterol and tracking a community, where you could follow out and see whether their disease indicators deviated from national norms because of this kind of investment.

          MR. DEVRIES:  In terms of using phrases like "outcome," I believe certainly those are important measures, but I think it gives us some consistency in terms of tie-back to other areas of our report focusing on clinical efficacy and safety; however, it doesn't preclude the process to say there are other important elements that we want to study at the same time, which include outcomes.  It also could include other benchmarks.

          MR. CHAPPELL:  But by clinical, we still have plenty of latitude of how we would design that clinical study?

          MR. DEVRIES:  Absolutely.

          MR. CHAPPELL:  Yes.  Okay.

          MS. MILLER:  I might just add that on the phrasing about methodologies and data, I think this was an effort to, when this body is convened, that issues unique to health services research and data and what bill and claims data is available for conducting these studies, that those issues can be addressed so all parties are dealing with them at the same time, rather than each research group struggling with that individually, that we put a lot of minds from a lot of different parties together to resolve those particular issues, some of which have come up before this Commission.

          MR. CHAPPELL:  I think it might be helpful if we identify some of the public and private bodies that have come before the hearing process, just so that the recommendation actually identifies potential partners here, because otherwise the recommendation might be a point of departure, but the people would have to start over.  Whereas, there are players that have come here that have said they would like to be involved in such a partnership.

          So, by being impartial, we could list some of the people that have presented here around this.

          MR. DEVRIES:  We would probably need to get their buy-off on that, but you are absolutely right, there have been plenty of organizations that have come forward and said they would like to participate.

          Ming.

          DR. TIAN:  I think the recommendation, it would be very important to mention, you mention on your first page, that some CAM practice should be first considered.  I think we should consider those that are licensed first.  I have a little bit of problem, if it is not licensed, how can we work on the coverage.  It is difficult if the CAM therapy is not licensed.

          If it is licensed, it means it already shows that there is some evidence which it is safe and effective.

          So, page 1 will mention that, where there is such evidence, the evidence has to be more specific, for instance, at what level.  For instance, it is proved by  an NIH conference like acupuncture, or it is licensed in 50 states as a chiropractor.  We have already got the evidence.  You can't say one scientific paper would be the evidence.  Then you need some people to review, to have experts review.

          But, again, I think more specifically, we should mention that.  It is my opinion, at least in all the CAM therapies and the products, some of them already are qualified to be covered, to be reimbursed.  Then we continue to do more, get more evidence, and to show more and more we have got the evidence.  You mention that it is safe, effective, we continue to do that.

          I think we need to mention that, because even Medicare does not cover acupuncture, for instance.  In 1997 it was approved by NIH.  They are still not doing that.  We need to mention that, because that is important.

            Again, we are back to the present order.  We are trying to help people to maximize the benefits.  I don't think that is right, if we already have evidence, you still don't do anything.

          MR. DEVRIES:  That is why, as we talk through this, it is a process to help break down those barriers and to increase coverage.  Hopefully, as we walk through all the recommendations, you will see the recommendations all work together to help cross those barriers as that evidence is already there.

          DR. GORDON:  I wanted to do two things.  One is to encourage us to move along.  The other is not to load too much on this first recommendation.  There are nine or 10 others, and I think this one is very general, and is deliberately, I think, kept general.

          Ming, I think you will see, later on, when the recommendations get more specific.  So, I think we need to keep moving, and some of the other issues that everybody has will come up.

          MR. DEVRIES:  I think Nos. 50 and 51 are generally tied together.  One is about collaboration and creation of the research.  No. 52 is about joint funding and not relying strictly on the government, but trying to encourage collaborative efforts related to funding.

          Any other issues there?  Move on to No. 52?

          DR. GORDON:  You were asking about both Nos. 51 and 52, right?

          MR. DEVRIES:  Actually, Nos. 50 and 51, because they were related, basically.  I was feeling that we could move on.

          DR. GORDON:  I think people need to take a look at 51, because I haven't heard the questions address that yet, so I would like to get a sense if there are any issues first with 51 before you go on to 52.

          MR. DEVRIES:  Okay.  No. 51?

          [No response.]

          DR. GORDON:  Okay.  That is fine.

          MR. DEVRIES:  No. 52.  I think this addresses part of Ming's question, what is the process, if there are studies available that certain CAM modalities or products have been shown to be safe and effective, what is the process.  It is really encouraging purchasers to develop and maintain a process to evaluate coverage for effective and safe CAM services.

          We need to recognize health plans do have a process for evaluating coverage.

          DR. FINS:  One of the areas that might be very helpful for the background section, for two reasons, is the Oregon Plan experience in the early '90s where they got a waiver from Health and Human Services to initiate the Oregon Plan and have a diagnostic treatment pairing for Medicaid beneficiaries.  They had a method of linking cost benefit analysis and public input into creating a categorization of like 600 or so diagnostic treatment pairs.

          So, there is a process that might have utility to draw upon here in just discussing how we might consider what is value-added, what is effective.

          The second point is when they did their first go-round, they had actually left out mental health coverage in the first go-round, and it was just physical medical issues.  People said there should be parity for mental health and that it should be included.  On the second go-round, they included mental health.

          So, I think there is a parallel argument here.  We are saying that if a CAM modality is safe and effective, it should be included in the current structure of what is covered, just as the mental health piece was integrated into the Oregon piece.  So, I think there may be some background there that might be helpful to make the argument.

          The point of this is not that we have to demonstrate scientific or efficacy kinds of considerations.  The fact is we are saying that if that is there, you are making a philosophical statement that there should be coverage if it is safe and effective, as good as, or better than standard of care, it should be included.

          MR. DEVRIES:  We could perhaps get some background on the Oregon Plan, look at that in the workgroup.  Okay.  Thanks, Joe.

          Anything else on No. 52?

          DR. GORDON:  I just have one question there with the word "encourages," which you sometimes use.  It is not as strong a word as "recommend."  Why have you chosen the wording?  I guess I am saying I would be a bit stronger with this.  I would recommend, because encouraging is nice, but --

          MR. DEVRIES:  "Encourage" versus "recommend," I think those words both are workable.  Okay.  Thank you.

          DR. GORDON:  Does that resonate with other people, as well?  Okay, good.

          MR. DEVRIES:  No. 53 is really -- and we can say the Commission recommends, based on the Chairman's recommendation -- but, basically, I think No. 53 is really about encouraging CAM providers and provider associations to, where appropriate and where there are opportunities, to participate in this process of helping to establish coverage and develop benefit programs.

          MS. MILLER:  I might just back George up by saying that I think this gets to some of what Ming was bringing up, and others, that there is there process out here, and what we are talking about is that the people who run the processes should now include CAM, that is what we are recommending, and, likewise, on the other side, the CAM professions should become involved.

          So, it is a balanced approach.  It is really helping the current process work.

          MR. DEVRIES:  Comments?  Yes.

          DR. GORDON:  I think it is very good.  I am just wondering if there can be some more background justification for doing this, because the people who came to talk with us from federal agencies and elsewhere got interested, but in the course of talking with us, if you follow what I am saying.  There has got to be some process that engages them.

          I know you have some of the background information here, but I think the stronger we can be in making the case for why they ought to essentially change the way they are doing business, reach out and say to CAM professionals or CAM researchers, we want you on our advisory committee, we have got to give them a series of good reasons to do that.

          I would like you to formulate what those reasons are, and then present them, not necessarily in the recommendations.  Some of them may actually be part of the recommendations, some of them may just be the background.

          MR. DEVRIES:  Okay.  Any other comments on No. 53?  All right.  We will move on to Issue No. 2, Cost Effectiveness.

          Obviously, we have talked about clinical safety and efficacy as a key determinant in offering coverage for CAM, but if you look at it from the health plan's perspective, the payer's perspective, if you look at, how is Congress going to make a decision for coverage of CAM under Medicare, it is really going to be about, in many cases, here is our budgeted amount for health care benefits, here is what we have got available; what is this going to cost, and what is going to be the impact on the overall cost of our benefits plan.  It becomes part of the decision-making process for payers.

          There is more pressure, shall we say, on that process now than ever because of the rising cost of health care in general, related to pharmaceutical products and technology, as well as with an impending recession, there is more pressure by employers to try to keep those benefit costs down.

          So we identified, as a workgroup, this as a key barrier.  This is a key barrier in the whole process of adding CAM benefits, getting CAM covered and reimbursed.

          This Issue No. 2 really is about making a recommendation related to comparative health services research to demonstrate that if you take two pools of members and one pool of members has a basic medical plan without CAM coverage, the other pool of members has, in a sense, the same medical package, medical benefit plan, plus it has one or more CAM benefits, then looks at those two pools of members over time and compares the overall cost of health care for those two pools, that there can be a demonstration through that research that the pool of members that have CAM benefits, what is the impact of CAM, does it raise costs.

          If it does, is it a little, is it a lot, is there simply cost offset and there is no difference in cost, or is there perhaps cost reduction, where CAM helps to reduce the overall cost of health care.

          This is a critical area of research.  We decided to separate it out, as a workgroup, because it is such a significant barrier, and because, frankly, there is good, solid, clinical efficacy and safety studies related to chiropractic and other areas of complementary health care.  But, frankly, there is not good comparative health services research out there to truly help.

          It is the sense of the workgroup that with this kind of research, and with positive results from this research, it will truly drive coverage and reimbursement for CAM.

          Maybe we will just start with Issue No. 54.  If you have questions, in general, regarding this specific section, but we can start.  Effie, and then David.

          DR. CHOW:  That sounds really good.  Point of clarification.  The ones that offer CAM, can they choose only CAM, or do they have to choose the medical package and then add CAM to the treatment?

          MR. DEVRIES:  That is a good question.  I will share with you, in my business life I work with health plans to provide complementary health care.  My experience has been that regulators require us to only provide coverage for CAM services for members who have a medical plan in place.

          DR. CHOW:  The question is, do they have to have medical treatment, or can they choose just CAM treatment?

          MR. DEVRIES:  In terms of choosing treatment, it is freedom of choice.

          DR. WARREN:  Don't they talk about medical necessity?  You can't get a CAM referral unless you have proof of medical necessity, as a way of not paying.   That limits the selection of the patient, the choice of the patient, in whether they would rather have a CAM therapy or a conventional therapy.

          MR. DEVRIES:  Well, there are really two issues there.  One is in terms of establishing medical necessity.  Most health plans will require medical referral, which, Don, I think you are right, it becomes an access issue.  There also are plans, even under traditional HMO systems, that will allow direct access to CAM providers, such as chiropractors or acupuncturists.

          So, it is important in any type of research like this that those kinds of key factors are indicated.

          David.

          DR. BRESLER:  My question cuts across a bunch of your issues, but I think it needs to be raised.  It has to do with preventive medicine and wellness.  Many years ago, I was doing some research on hypertension, and was shocked to see that compliance of patients given anti-hypertensive medication is about 50 percent.  When these patients don't take their hypertensive medication, they develop heart attack, strokes, kidney failure, all of which are catastrophic in terms of their cost.

          I think the evidence of cost-effectiveness of taking medication or doing these interventions is overwhelming.  And yet, when we tried to approach the plans and say, here is an intervention, here is a CAM-type intervention to increase compliance, they didn't get it at all.  There was no understanding at all.

          I think the evidence for wellness as an intervention to prevent catastrophic costs is very, very strong in a lot of areas.  And yet, again, the medical necessity issue is one.

          Why are the plans not embracing CAM and a lot of these modalities in wellness programs and providing these kinds of benefits in order to reduce their costs?

          MR. DEVRIES:  I think that gets into a level of speculation.  I am not sure that there is a lot of value in getting into that.  I think we all understand that there are significant barriers there, and we are trying to create some concrete methods that will help us get, at least, over some of those barriers.

          DR. GORDON:  David, one thing I would suggest, and I actually heard this in the last three questions, is, if there are recommendations that you have for other kinds of cost benefit studies, that is what George needs to hear.

          In each of the questions, I am hearing some aspect of a recommendation.  I think that is what this committee needs right now, for you to tell him what you think.  Now, we can't go into all the details.  I think our task here is, if there are other issues, like the ones you have been raising, that need to be considered by this committee, you need to tell him what those issues are, and then follow up with him and the other committee members to help define those issues.

          DR. BRESLER:  I am addressing Recommendation No. 55, specifically.

          MR. DEVRIES:  Can we deal with --

          DR. BRESLER:  Well, it cuts across a bunch of them, but the question is, just because cost-effectiveness has been demonstrated doesn't mean anything, it seems to me, in terms of a change in the policies of these plans, in terms of what they are going to cover.  I would like to see us take a stronger stance on it.

          DR. GORDON:  So, the challenge back to you is, okay, what now.  I am not saying you have to answer that question now, but that is what you and George need to have the dialogue about.

          MR. DEVRIES:  Joe.

          DR. FINS:  This points to why we really need health services research and population studies that transcend individual plans.  I think they are getting at that in some of these recommendations.  The problem is with any preventative strategy is if you do the mammogram and you do the polypectomy and prevent the colon cancer, that cost, say for the colon cancer, was 10 years from now in a different plan.  The patient is going to have jumped from three plans from now.

          So, we really need to have long-term longitudinal studies, like the Framingham tracking of a population, to really understand whether this is cost beneficial or not and whether it promotes wellness.

          So, it really has to be a population-based study.  I think that this is totally constant with the kinds of goals from Health People 2010 and it really needs to be enveloped in the United States Public Health Service, the kind of work that they have done so well.

          Now just bringing in additional variables and having population-based tracking, because of the complexity that David is alluding to, you can't do that with a single plan.  We can say a modality works or not and whether people are happy or not, but whether it affects costs and mortality and morbidity and absenteeism and all those big issues, we need a population kind of study.  So, we should make a recommendation.

          MR. DEVRIES:  I think we can maybe add some wording to what we have got, in terms of some of our recommendations, to help there.  Understanding that employers, health plans, government payers have certain options and choices in how they build their benefit plans.  So we are trying to create ways to overcome those barriers.

          Let's look at draft recommendation No. 54.  Are there particular comments related to that draft recommendation?  We are going to add some wording based on Joe Fins' comments.

          SISTER KERR:  I really don't feel a particular expertise in this, but if I can say it, some of what Joe said, the whole idea that a person will have three different funding sources, perhaps by changing jobs, that the incentive is not for the first business to do wellness work, because they are not going to be around anyway, if you have gotten the colon cancer 10 years later, right?  So they don't have an incentive putting all the money in for wellness, correct?

          Now, the federal agencies would, because they are going to take care of people and have their health insurance for life and retirement.

          I am making some intuitive leaps.  Going back to our principles, going back to our world view, if we have a national goal to keep people well for a lot more reasons than to have a healthy country, and principles like we care about one another and we are building community, this is sort of going out of your whole, incredible work to say, how do you make a recommendation, how do you incentivize everybody so that we, in fact, want to keep people well, whether or not they are under this insurance policy now or later, in the same way we have funding to take care of child health.  If you don't do it then, you can't do it in 20 years.

          I know this is probably opening up conversation about national health insurance, but I don't want to go there.  That is almost like still buying into the system, I think, is bankrupt and hierarchical and authoritative, and not in our power, Don.

           How big can we get in thinking about this?  It is definitely out of the box, but I think it is a national goal.

          DR. GORDON:  I appreciate your remarks, Charlotte, because it highlights something for me.  I would say that these statements could be made much more strongly.  This relates to what David was saying earlier, as well as what Charlotte is saying, that it is time to do some significant studies on whether self-care, just as an example of one that is stated, the cost and benefits of self-care and working with people who are particularly vulnerable to chronic illness.

          Some statements that are stronger than we have made them here, I think we are in a position where we should be doing that.  We should be doing it now on a large scale.  It may wind up taking a number of years, but once we get it started, I think we will start seeing the benefits.  That is what I would like to suggest.

          MS. MILLER:  We will add that as a new recommendation.

          DR. LOW DOG:  It goes here, I guess, too, but also under the self-care, where really following through to see how it impacts health.

          I think Charlotte is right, it is a bizarre situation because of all the changing.  My patients, their insurance changes.  Every four and six months, they have got something different.  So it is hard.

          I think that is where the federal government may be able to step in, also, working with Public Health Service, and working with some of these other groups to fund some of these studies to show the impact that this has.

          MR. DEVRIES:  If you look in the context of wellness in terms of self-care related to good nutrition and exercise, and just certain fundamentals, I don't believe it has an impact 10 and 15 years from now.  I believe it has an impact in 90 days to 12 months.  People see positive improvements in their health care that quickly.

          On the one hand, I understand some of the impact is 10 years plus, but I have got to believe the majority of the impact, especially in those kind of areas of self-care, is very short-term.  Therefore, I think it supports what we are saying, which is, there is value to the health plans funding it.

          I think part of it is we are saying, given the system we currently have, how do we demonstrate that through research and other activities, how do we demonstrate that, and how do we basically move the current health care system to not just including coverage for clinical services like chiropractic and acupuncture, but areas of self-care like nutrition and exercise and others.

          SISTER KERR:  In terms of short-term impact and, actually, what do people ask for, Bernadine Healey, as everybody knows as head of Red Cross, was speaking with some members of Congress.  At the Pentagon site -- this is just to go into immediate care, and this is the short version -- as we all know, everybody needed their first aid, whether it was washing out the eyes, and they had everything else there, of course.

          But, do you know what one of the top requests was?  They wanted to talk to somebody, and they wanted spiritual care.  I am telling you, that is what is getting those people through.  It isn't validated in this study, and it is not covered by an HMO.  It is what people need, and are going to need for quite a long while, with immediate results.

          MR. DEVRIES:  Joe.

          DR. FINS:  I was going to say bereavement services is another issue that comes up.

          I think, in a sense, the wellness, I think, is less necessary to prove, because if we were doing Framingham today, we would call it a CAM study.  It is about smoking cessation, it is about exercise, it is about good diet.

          I think what we really need to prove is to prove that interventions and delivery systems, not necessarily wellness, I think we all know wellness makes a difference, but how do integrated service delivery systems impact on morbidity and mortality?

          DR. GORDON:  We have 12 minutes left.  We have about seven more recommendations.  Even if we give you another eight minutes, so I am left with seven minutes at the end, still we have got to move.

          What we are looking for is not the answers to this.  We are looking for direction.  I think we are getting the direction, but let's focus.  We have about seven or eight more recommendations, and George and his group need guidance from us about other issues that should be addressed.

          MR. DEVRIES:  On some of these more complex issues that we have just been talking about, we would welcome you, if you want to put something in writing or join one of our conference calls with our workgroup, please do.

          Back to Recommendation No. 54.  Anything else there?

          DR. GORDON:  No.  Move on No. 57.

          DR. CHOW:  I just wanted to say that that recommendation, the last sentence there covers what we are saying.  I would make that stronger and expand that a bit.

          MR. DEVRIES:  Are recommended?

          DR. CHOW:  Yes, because that takes in what we were discussing.

          MR. DEVRIES:  Thank you.  Joe?

          DR. PIZZORNO:  This actually may be more appropriate to the staff writing this, this particular recommendation, but I am noticing that we are often just saying CAM modalities or CAM therapies.  We need to continue to include CAM systems and CAM practitioners.  I know there is about 100 places where I have noted this in these notes.  So I would just like to request that we are looking at not just modalities, we are looking at systems and practitioners.  We just have to be more careful with that language.

          MR. DEVRIES:  So, No. 54.  How about No. 55?  We have really talked about that.  No. 56.

          DR. FINS:  Just on 55, I think it is very vague.  We are not recommending they cover something.  It is really they cover in the context of what their allocation scheme is, depending on how much money they have.  It may be safe and effective, but they may not be able to afford it, and they may have other priorities.

          So, I don't know what we are really trying to say here.  We want to say they should not be prejudicial against a modality that is safe and effective, right?  But we are not recommending that they actually cover it, it is just that they consider its coverage in a non-prejudicial way.

          MR. DEVRIES:  Right.  That would be a good topic for the workgroup.  Would that be all right?  I think that is an issue we could spend a fair amount of time on, but I understand.

          DR. JONAS:  I actually like the wording in this thing, because it does say consider.  It is not saying fund.  It is saying, we recommend that if something is proven safe and effective, then the various agencies, taking into consideration all the other issues that they have to take into consideration, consider funding them.

          I actually like a lot of that kind of wording, which is spread through many of these applications, which is less confrontational and more integrative in approach.  So, I commend you on that.

          MR. DEVRIES:  Thank you.  Are we ready to go to No. 56?  No. 56 really is about encouraging federal programs to have an ongoing effort to evaluate the benefits, so that there is a process that ultimately gets us there.  Comments there?

          No. 57.

          DR. FINS:  This might be, if we come to a CAM central sort of approach, there needs to be some mechanism to close the loop on what all that data shows, those administrators, where they report and who culls the data and makes sense of it.

          MR. DEVRIES:  Right.  Later there is a recommendation in terms of collecting information to give reports to Congress.  Certainly CAM central would be critical if there was that type of report.

          All right.  No. 57, this really relates to making sure that the CAM professions are evolving their CPT coding to reflect the services, so that they can be appropriately reimbursed in third-party reimbursement systems.  Yes, Joe.

          DR. PIZZORNO:  We had quite a bit of discussion about this, and I think we have to walk carefully.  I am concerned that if we develop CPT codes that are just for CAM therapies, interventions, and practitioners, we run the risk of ghetto-izing those groups and having progressively decreased reimbursement for them.  When we do a primary care intervention, whether a chiropractor, naturopathic doctor, medical doctor, et cetera, we should all be involved in the same CPT code and not have separate CPT codes.  So, I want to be careful with the language that we don't segregate ourselves out.

          MR. DEVRIES:  Thank you, Joe.

          Anything else there?  Ready to move on to Issue No. 3?  Issue No. 3, which is acknowledging that licensure is a minimum issue for most health plans or payers and therefore we had one recommendation, which is No. 58 on page 7, that, basically, to increase access and coverage of CAM therapies is to really encourage state agencies, to make sure that they are appropriately licensing, certifying, registering providers consistent with their education and scope of practice.  This, ultimately, is going to result in more coverage, more reimbursement, better access to these services.

          DR. GORDON:  I think it is a good recommendation.  I think it is one of those that needs to be tied back into the other sections on licensing and credentialing.

          MR. DEVRIES:  Right.

          DR. JONAS:  I find it a bit confusing, because you mention that if there are safe and effective therapies that then it encourages governments to grant authority to practice professions.  Perhaps that needs to be reworded a little bit, because the goal here seems to be when there are safe and effective therapies that there be a method of allowing them to be covered and have access to them.  It just seems to be mixing a couple different things, maybe just rewording that.

          MR. DEVRIES:  I think you are right on that.  I think the workgroup needs to do some work there.

          MR. CHAPPELL:  Again, I am thinking of what might be an operating idea to advance this.  I am thinking about a national meeting of the Association of State Government Health Care Departments to dialogue about various CAM modalities, state to state.

          I think when you get people out of their own state and mingling with other people across the land and they see what other states have done to bring this into coverage, it gives them a little more incentive to do the same in their own state.

          MR. DEVRIES:  Perhaps the federal government can support or facilitate that process of governments sharing information.

          DR. FINS:  This is what we were talking about in our last group, the Uniform Code.  Our last recommendation was to catalyze this very dialogue.  So I think it is there.

          DR. JONAS:  There is a forum already for doing that, too, which is the National State Legislators, which has an annual association and have had forums at those meetings on CAM licensure, practice, and this type of thing.  So, to facilitate that process and stimulate it would be one way to do that.

          DR. GORDON:  I am trying to get clear, we are looking for a way to put this into practice.  Is that right?  And we haven't exactly found the way, but there are a number of suggestions.

          MR. DEVRIES:  Part of the fact, and I believe it goes back to there are ways to do it, and one of the ways to do it is simply making the recommendation in the Final Report, because if the recommendation is put there, I believe it provides clarity as a recommendation to state legislatures.  There are grass roots efforts out there by providers trying to improve the licensure statutes of their state or to create a licensure statute in their state, and the Final Report in references related to this simply provides them with very real, concrete support that they can point the state legislature to.

          So the facilitating process by the federal government is excellent, but don't minimize the value of just having it in the Final Report that it can be something they can reference.

          DR. GORDON:  I would say that we are now splitting it.  There are two recommendations here that you need to go back and think about.  One specifically has to do with saying to the states, you should consider licensing these people.  The other has to do with an action step of bringing responsible people in the states together to look at the issues.  Is that correct?

          DR. FINS:  I would just refer us all back to our recommendations 38, 38, 40, and 41, and the background sections and the taxonomy, because all of these things are related to this charge about establishing legal authority, ultimately to improve access in a safe and secure way.

          MR. CHAPPELL:  But, yes, you are right, Jim.

          DR. GORDON:  Okay.

          MS. MILLER:  We will work with access on that.

          MR. DEVRIES:  Thank you.  Anything else on Issue No. 3, licensure?  This recommendation, we will take it back, we will work on it, we will split it into two recommendations.

          Moving no to Issue No. 4, which was really the issue of the concept of medical necessity, that basically health plans use it as a definition in terms of what to cover, employers use it as a definition of how they would define their benefit plans.  The IRS Tax Code uses it as a stipulation of what can be covered as a fringe benefit, what employers, therefore, can deduct as an employee benefit plan, and what employees can receive, their employees and their dependents can receive as a tax-free event, as a tax-free benefit.  So, it is language and medical necessity requirements are broad based.

          DR. BRESLER:  It seems to me that this IRS statute completely dis-incentivizes insurance plans from providing any wellness benefits.  Again, here seems like an area where we could make a very strong recommendation, not to tell the IRS what to do, but I don't think government should be dis-incentivizing prevention and wellness programs by making them taxable events.

          MR. DEVRIES:  Just to understand the magnitude of it, there is a senate bill that has just been introduced, the Dietary Supplement and Fairness Act, which is all about the Tax Code issues, and it is sponsored by Senator Harkin and Senator Hatch, and basically it is about allowing employers to buy coverage for vitamins and herbal supplements and that it be considered a fringe benefit.

          I am saying that this is an issue out there.

          DR. BRESLER:  Can our Commission make stronger recommendations about not dis-incentivizing wellness and preventive programs in this way?  Isn't this something we could do?

          MR. DEVRIES:  Yes.  We are going to take that back, in terms of making recommendations along those lines, because we have not done that here, and it is something that even just in this meeting we have been talking off-line about the IRS Code statutes and their impact, really, on coverage and reimbursement.

          Effie and then Joe.

          DR. CHOW:  On the issue about incentive for wellness, there is a program -- and this has often been my ideal, and it is going way out there -- but there is a very large organization in Wichita, Kansas, The Improvement of Human Function, Dr. Hugh Reardon, a physician who does workmen's compensation assessment and everything, they offer wellness day instead of sick days.  Is that too far out to pose that type of a query or recommendation?  They get wellness days, they do not get sick days.

          MR. DEVRIES:  I think that might be more under the self-care and the wellness that we will be discussing later.  Thank you.

          Joe, and then I think we are going to move on, try to, if we can, look at the draft recommendations quickly.

          DR. PIZZORNO:  Just a quick question.  Does the proposed legislation include in the IRS deduction prescribed supplements as being included for the deduction?

          MR. DEVRIES:  It is broad based in terms of nutritional supplements.

          DR. PIZZORNO:  You said one is for coverage if it is part of a health care plan, but if it is just prescribed by somebody who is not on a health care plan and they had to buy it themselves, is that included?

          MR. DEVRIES:  No, that is not covered.

          DR. GORDON:  I'm sorry, I have a question.  Aren't we discussing Recommendation Nos. 59 and 60?  Or, are we?

          MR. DEVRIES:  We are.

          DR. GORDON:  I don't know that we have addressed the recommendations yet.  I may have missed something in the discussion.

          MR. DEVRIES:  We have gone a couple different directions.

          DR. GORDON:  Okay.  So, we have eight minutes left.  We need to address these and decide what to do with them.  I am not saying we shouldn't talk about the other issues, that goes back to the committee; but what about these two recommendations, they need our guidance about that.

          SISTER KERR:  I just wanted to clarify, the senate bill was to give a break so that people could pay for the drugs to be a fringe benefit for the employees, correct?

          MR. DEVRIES:  It was to allow employers to buy coverage for nutritional supplements.  I will get you a copy of the bill.

          SISTER KERR:  I will tell you why I am asking.  Was it nutritional supplements?

          MR. DEVRIES:  Yes.

          SISTER KERR:  All right.  I will just let it go.

          MR. DEVRIES:  Shall we go to Recommendation No. 59?  Comments?

          [No response.]

          MR. DEVRIES:  We will change "encourages" in both Nos. 59 and 60 to "recommends."  Anything else?  How about No. 60?

          DR. GORDON:  I think that maybe the previous discussion comes in here, where we talk about bringing wellness in, giving a sense that medical necessity, which always seems to have the feeling of overwhelming response to a life-threatening illness, that we introduce here the concept that is different, a focus on health and wellness is some aspect of medical necessity.

          Maybe that is why there has been so much discussion of those issues in relationship to this group of recommendations, that that is what we are trying to reach for.  I am not sure about that.  That is as much a question as it is a statement, but I feel like that is what is missing here, that we need to expand the definition of "medical necessity."

          MR. DEVRIES:  The challenge is the definition of "medical necessity."  We can make a recommendation related to a "medical necessity" definition, but the "medical necessity" definition that is used by payers is one that, I think, is probably more strict.  I am just saying we can make that recommendation, but recognizing that this is a fairly well-ingrained part of the structuring of employee benefits.

          David, and then Joe.

          DR. BRESLER:  I would suggest that your committee take another look at worker's compensation code, because, as a primary treating physician under Comp, when I say it is medically necessary for wellness interventions in order to maintain a permanent and stationary status of a patient, wellness interventions are accepted under Comp.

          DR. FINS:  Another way to get inclusion, without getting into the thicket of medical necessity, is to encourage plans to have the membership articulate their preferences for what gets covered, what doesn't get covered, a la Puget Sound, which is very well known for its membership inclusion in establishing the benefits.

          If there is money left over, and it is discretionary, how does it get distributed.  There should be a kind of community involvement of shareholders, members of plans, that kind of language.

          DR. GORDON:  My response, that is a great idea, and that is really a whole new recommendation that we haven't included yet.  I think it could be very important and probably in this section.

          MR. DEVRIES:  What I have seen is where employers can choose to purchase benefits that are more restrictive, less restrictive in terms of an application of medical necessity, and they are priced accordingly.  The one perhaps costs more, but is valued and therefore paid for.

          DR. FINS:  It is the marginal cost that is really what is up for grabs, and that might be exorbitant, but people should have the ability, perhaps, to make that marginal choice for a carve out or supplemental or something.

          MR. DEVRIES:  And I think you are seeing some health plans who are moving in that direction within their plans to have more options there.

          Tom, did you have a question?

          MR. CHAPPELL:  I guess I am looking again for sort of some operating idea that would advance this No. 60 into some real face-to-face dialogue among the stakeholders, and whether it is regional gatherings that we are sponsoring, but something that tries to put in the minds of the reader the fact that we want to see the federal arm create the dialogue for more of this opportunity.

          MR. DEVRIES:  You want to facilitate it?

          MR. CHAPPELL:  Yes.

          DR. GORDON:  That sounds great.

          MR. DEVRIES:  Could the workgroup take a stab at that and come back with some language?  That is a good recommendation.  Thank you.

          Any other comments, Issues 59 and 60?  Effie.

          SISTER KERR:  Not Nos. 59 and 60.  I just would like to say this.  Back to the issue of the Senate bill and the dietary supplements, and I am saying this to us as a group.

          David, you have got some really practical, good ideas.  Sometimes I feel like there is collusion to fund the drugs, or dietary supplements that are so-called, maybe an idea being more creative.  But, do you see where we still miss a different model, conceptually?

          Like if we are going to fund a dietary supplement or drugs for anxiety, why aren't we just putting in there qigong, fund that and group therapy or something?  Do you see?

          I think, as a Commission, we need to start thinking that way, what would be a recommendation that is a bit broader than supporting either drug companies or dietary supplements.  It is a modality approach.  It is not either/or, and that is fine.  But we have got to do the either/or sometime in here.

          MR. DEVRIES:  Thank you.

          DR. GORDON:  I would just say, Charlotte, that is exactly the kind of recommendation and specificity, as well as embodying the philosophical approach, that can be included in Nos. 54, 55, 56, 57, some of those recommendations for looking at some of these approaches.  I think it is important.  That will give it a concreteness, as well as embody our whole philosophy.

          MR. DEVRIES:  Moving up to Issue No. 5, last issue, and Recommendations Nos. 61 through 63.  I think the concept of providing information is that employers and health plans need more and better information on research, both clinical efficacy and safety, and comparative health services.  They also need better information and understanding on the licensure of CAM providers and how that protects their patients and provides credible resources for them to work with, the availability of providers.

          Basically, there are three recommendations, Nos. 61, 62, and 63, related to this.  The first one being focused on the information through a federally-sponsored website, perhaps through CAM central that would provide employers and health plans with that type of information.

          No. 62.  Just to say quickly, that is really about where a CAM central or other various particular agencies to periodically report to Congress and the President the status of research, coverage, access, and availability of CAM services.

          Finally, No. 63 is really to encourage the collaboration process that we have been talking about on development of information.

          DR. GORDON:  I have a couple thoughts on these.  I like the recommendations.  I think, on No. 62, that it should include Federal Employee Benefit Plan, and I think that they should be reporting not only to Congress, HHS, and the President, but also to all their members, letting them know what they are doing.

          Do you follow what I am saying?

          So, if you go to the VA, you ought to know, as a soldier, what the VA is doing for you.  I feel that that is a terrific recommendation.

          No. 63.  I think, again, following Tom's lead, I think there should be an action step, and I think there should be money to pay for inclusion.  It is amazing if you give people $25- or $50,000 what you can get into a conference.  A very small amount of money, you can begin.

          I think the terrific example that was given to us was of getting issues of spirituality into medical school curricula, Templeton Foundation giving $10-, $15-, $25,000, and getting it in.

          So, I think if we can look at ways of getting this kind of dialogue going in conferences, small grants -- it could be from NCCAM, it could be from AHCPR, it could be from HRSA, it could be different places -- that could make a huge difference.  I just want to suggest an implementation step here.

          MR. DEVRIES:  Good recommendations.  Thank you.

          Others?

          [No response.]

          MR. DEVRIES:  Okay, I think that finishes up, and I give it back to the Chair.

          [Applause.]

          DR. GORDON:  Thank you very much for a really good job.

          Let me go through this quickly.  We did a lot of this work as we went along.  To begin with, there was considerable interest in seeing more information, seeing the whole debate on safety and efficacy, the whole discussion, fleshed out considerably more and presented and then talked about again at our next meeting, because there was a lot of questions about that.

          In terms of Recommendations Nos. 51 and 51, particularly Recommendation No. 50, again, more specifics.  We are really sending this back to you for more specifics about what the nature of these kind of partnerships would be.

          No. 51, although there were perhaps some of the same issues, essentially we were asking you to look at No. 51 in the same way as No. 50.

          No. 52, we felt there was a stronger statement, rather than encourages.  I think throughout Nos. 52 and 53, there was a sense of the more we can do to advance this agenda, the better, and that the statements have to be stronger.  But I didn't see anything in the content that needed to be changed.  I may have missed something there, but I don't think so.  If I did, please let me know.

          No. 54.  There are questions of how approaches can be integrated, what other approaches need to be added, issues of wellness come in here, issues of specific examples, there was a feeling that the group needs to work on that aspect of these recommendations.

          No. 55.  I think that what we said is that this wording worked, but I am not completely sure of that.

          Am I right about that?  That we decided that consider was the appropriate word there, after some discussion?

          No. 56.  Again, if there could be more action steps within No. 56, that might advance that.  It seemed a little bit vague at this point, and there may be ways in reconsidering it that you can find that.

          No. 57 seemed appropriate and then it looked like, again, I think what we started coming to is the more we can move in the direction of having some action steps for these recommendations that saying looking at, what exactly does that mean, and the more you can come up with in terms of saying what that means, the further along we will be.

          No. 58, which is the "encourage state government to grant legal authority to practice those CAM professions seeking license or equivalent stature."  Part of No. 58 needs to go with the general discussion about licensure, but there is also an interest in some kind of state gathering, perhaps.

          I think trying to put together a few of the recommendations, we can look at what we would suggest for an agenda of state health officers in some kind of meeting.  We might take some of these recommendations that refer to states -- and I am trying to put it together in my own mind now -- and make a more general recommendation for the kinds of things that such a gathering might look at, pulling it out from several of the specific recommendations that were made here.

          No. 59.  It seemed to me that there was a significant discussion about wellness programs, and explaining a little bit more about necessity and appropriateness, and outlining necessity and appropriateness, you raise the issue how necessity and appropriateness might relate to CAM.  I think what you are hearing from us is the more of an answer that you can give, the better it will be.

          No. 60.  There are two sides to it.  We added a second part.  "The Commission encourages insurers and benefit experts, managed care organizations," et cetera, "to work cooperatively with CAM professions to develop criteria for appropriate coverage."

          There is also a second issue, I think Joe raised it, of pushing, as best we can, for those groups, and we might begin -- I am just adding now as a possibility -- with federal agencies where we can have more direct input, finding out what their consumers want. This has been done sometimes.

          Joe's suggestion was this should be a general kind of policy.  It is not enough just to talk about the benefits, but a kind of previous step or an ongoing step is what exactly do consumers, members of these groups want for their health care.

          No. 61.  The website; it seems like we are in agreement.

          Go ahead, Joe.

          DR. FINS:  One last point, it may dovetail with a patients' bill of rights about participation.

          DR. GORDON:  That comes very much back to our 10 principles from the beginning.

          DR. FINS:  Right.

          DR. GORDON:  I think, again, there is a sense, and I heard this particularly from Charlotte, of anchoring recommendations about coverage also in the 10 principles.  So if those references can be there, that will help advance and tie together our recommendations here with our overall perspective.

          No. 62.  I spoke about including the health benefits for federal employees here and also providing information to the patients, to the consumers, to the people, about what benefits are available for them and what benefits are available throughout the government.

          No. 63.  The recommendation was to suggest an action step of providing small supplements for conferences to address some of these issues.

          Are we okay?

          [No response.]

          DR. GORDON:  Great.  It is lunch time.  We will adjourn until 2:00, and then we will come back and we will be addressing wellness.

          [A lunch recess was taken at 1:00 p.m.]

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