[This Transcript is Unedited]

Department of Health and Human Services

National Committee on Vital and Health Statistics

Subcommittee on Standards and Security

January 29, 2003

Hubert Humphrey Building, Room 705A
200 Independence Avenue, S.W.
Washington, DC 20020
Proceedings By:

CASET Associates, Ltd.
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TABLE OF CONTENTS


P R O C E E D I N G S [9:12 a.m.]

Agenda Item: Call to Order and Introductions, Review Agenda - Dr. Cohn

DR. COHN: Good morning. Can we all please be seated and we will get started here? Good morning. I want to call this meeting to order. This is the first day of two days of hearings of the Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics. The Committee is the main public advisory committee to the U.S. Department of Health and Human Services on national health information policy. I'm Simon Cohn, I'm a physician and chairman of the Subcommittee, I'm the national director for health information policy for Kaiser Permanente. I just want to welcome fellow Subcommittee members, our HHS staff, and others here in person. I also want to welcome those who are listening in on the Internet, and obviously as always, I want to remind everyone to speak into the microphone since we are on the Internet, so that people can hear.

Today we are focusing on provider payer and research needs for code sets for complementary and alternative medicine. I want to thank Kepa Zubeldia, Stan Huff, and Richard Nahin for their work putting this hearing together. Tomorrow we will continue our investigation into ways to improve and stabilize the HIPAA process, and we have a couple of sessions tomorrow morning, panels and discussion related to that. For that I obviously want to thank Karen Trudel, Jim Shuping, and Stan Nachimson for their help in terms of putting those panels together.

Finally, at some point, either at the end of the day or tomorrow as time permitting, I want to review the Subcommittee priorities and issues for 2003, and get your sense of how we should prioritize our activities and focuses for this coming year.

With that, let's have introductions around the table and then around the room. For those on the National Committee, I would ask if there are any issues coming before you today for which you need to publicly recuse yourself. With that, Stan do you want to continue with the introductions?

DR. NACHIMSON: My name is Stanley Nachimson, I'm with the Centers for Medicare and Medicaid Services in the Department of Health and Human Services, serving as staff to the Subcommittee.

MR. BLAIR: I'm Jeff Blair, vice president of the Medical Records Institute, I'm vice chair of this Subcommittee, and in turn, there's nothing I need to recuse myself of, but in terms of full disclosure, I'm a member of HL7, ASTM, and HIMSIS.

DR. HUFF: I'm Stan Huff with the University of Utah and Intermountain Health Care in Salt Lake City, and I don't know of any conflict either. I participate in LOINK, and HL7, and a lot of related terminology work.

DR. STEINDEL: I'm Steve Steindel, senior advisor for data standards and vocabularies, Centers for Disease Control and Prevention, liaison to the full Committee and staff to this Subcommittee.

DR. FITZMAURICE: Michael Fitzmaurice, senior science advisor for information technology to the director of the Agency for Healthcare Research and Quality, lead staff to the Secretary's Council on Private Sector Initiatives to Improve Security, Safety and Quality of Health Care, liaison to the National Committee and staff to the Subcommittee on Standards and Security.

DR. FERRER: Jorge Ferrer, medical officer at the Centers for Medicare and Medicaid, and I'm on the staff of the workgroup.

DR. KAIL: I'm Konrad Kail, I'm a naturopathic physician, I represent the American Association of Naturopathic Medical Colleges and the Southwest College of Naturopathic Medicine and Health Sciences.

DR. NAHIN: I'm Richard Nahin, I'm with the National Center for Complementary and Alternative Medicine at the National Institutes of Health.

DR. BICKFORD: Carol Bickford, registered nurse, American Nurses Association.

DR. MILLIMAN: I'm Bruce Milliman, Naturopathic physician, and I represent the American Association of Naturopathic Physicians today.

MS. PICKETT: Donna Pickett, Centers for Disease Control and Prevention, National Center for Health Statistics, and staff to the Subcommittee.

MS. GREENBERG: Marjorie Greenberg, NCHS, CDC, and executive secretary to the Committee.

MS. BEBEE: Suzie Bebee, NCHS, CDC, and staff to the Subcommittee.

DR. ZUBELDIA: Kepa Zubeldia with Claredi Corporation, member of the Committee and Subcommittee.

MS. SQUIRE: Marietta Squire, NCHS, CDC, and staff to the Subcommittee.

DR. SABA: Virginia Saba, developer of the Home Health Care Classification System, which is in the ABC codes.

DR. STEVANS: I'm Joel Stevans, I'm a chiropractor, and I represent Landmark Healthcare.

DR. FAUST: Paul Faust, Naturopathic physician, director of Chesapeake Natural Health Center.

DR. CULLITON: Patricia Culliton, licensed acupuncturist, and director of the Alternative Medicine Division at Hennepin County Medical Center.

MS. WHEELER(?): Gladys Wheeler, Centers for Medicare and Medicaid Services.

MR. MORGAN: John Morgan, Incubation, Inc.

MR. TRIALER(?): I'm -- Trialer, vice president of Professional Governmental Affairs, American Specialty Health, I'm a chiropractor.

MS. WADE: Geraldine Wade from CDC, on detail to HHS to support the NHII activities.

MR. MUSKO(?): Tom Musko, director of research and statistics at the Health Insurance Association of America.

MS. FEINBERG: Laurie Feinberg from CMS.

MS. MOLINA: Synthia Molina, CEO of Alternative Link.

MS. GIANNINI: Melinna Giannini, president, Alternative Link, and board member of the Foundation for Integrative Health Care.

DR. FREIBERG: Richard Freiberg, doctor of acupuncture and oriental medicine, acupuncture physician in Florida, vice president and legislative chair of the Florida chapter of the National Guild of Acupuncture and Oriental Medicine.

MR. DUMOFF: Alan Dumoff, I'm the executive committee of the Integrated Healthcare Policy Consortium.

DR. HARAMATZI(?): Madi Haramatzi, I'm from Georgetown University School of Medicine.

DR. COHN: Well, I want to thank everyone for coming and joining us today. I should also comment myself since we've been doing introductions that as chair, with another hat on I sit on the CPT editorial panel, and therefore I will be publicly recusing myself from any discussion that relates to CPT today.

With that, I've actually asked Kepa Zubeldia, who's been intimately involved in the development of this hearing today, to actually chair the session, and Kepa, would you like to take over and provide us with a couple of introductory comments?

DR. ZUBELDIA: This session today is an attempt by our Subcommittee to explore the issues related to complementary and alternative medicine coding. We're talking to some providers and some payers today. Obviously, it's impossible in one hearing to listen to everybody that is involved in coding complementary and alternative medicine. So we expect to have at least one more hearing and to cover some of the other specialties that we're not hearing about today. We have received correspondence from several other specialties that are not covered here and we feel like we need to hear from them, too.

With that, the expectation for us is more an informational meeting. We would like to know what are the coding issues today, what coding systems are being used, you have received a list of questions, that's essentially what we want to know about. If you feel like there are some additional information that was not covered in the questions we sent you and you want to cover that, just feel free to do that. We also have some news, that Stanley wants to read a letter that impacts the use of some alternative medicine coding under HIPAA.

DR. NACHIMSON: This is a letter in regards to approving a pilot test for a set of codes for complementary and alternative medicine based on an application that the Department received. I'll just read the letter, which went to Alternative Link and the Foundation for Integrative Health Care.

Thank you for your letter requesting an exception from the use of HIPAA code sets to test a proposed modification to those standards. Specifically, you propose to test the use of the ABC code set to describe the products and services delivered by complementary and alternative medicine and nursing practitioners. Your application indicates that the current adopted standard code sets do not contain adequate or specific elements to describe a number of alternative therapies and procedures. Our understanding is that the ABC code set would be used in conjunction with HCPCS codes. I am pleased to approve this request, subject to the conditions set out below. Yours was the first request we received for an exception under section 45 CFR 162.940, and this process is critical in order for the HIPAA standards to improve and evolve over time. Please note that the conditions set out several additional pieces of information that you will need to supply prior to commencing the pilot. In addition, we have enclosed some guidance for your use in establishing an evaluation methodology.

I'm going to read the conditions for approval. Approval covers the use of the ABC code set by HIPAA-covered entities (health care providers, health plans, and health care clearinghouses) to describe products and services in HIPAA transactions. And the use of the codes by non covered entities or for purposes other than conducting HIPAA transactions is not governed by the HIPAA regulations.

The start date of the pilot will be determined by you after consultation with the pilot participants. You may begin at any time prior to October 16, 2003. The duration of the pilot will be two years from the start date. You must notify us of your proposed start date and of the actual start date within 30 days of that date.

Participants must include health care providers and at least one health plan, and electronic transactions must also be included.

You must identify all pilot participants within 60 days of the date of this letter, which is January 16, 2003. Please provide a complete list including name, address and tax ID number. This information is needed in the event that a complaint is submitted against a participant related to the participation in the pilot project. You may not add participants after submitting the list.

The pilot evaluation must be conducted in according with the criteria in 45 CFR 162.940. If the pilot participants include non-covered entities or the code set is used for other purposes than conducting for the transaction, the evaluation must clearly differentiate the costs and benefits from those.

We look forward to seeing the results of this pilot. We encourage you to submit your evaluation methodology for our review prior to starting the pilot, we'd be happy to meet with you to review it. You should submit the additional information requested to Jared Adair, director, Office of HIPAA Standards, and contact here if you have any further questions.

The letter is signed sincerely, Tommy G. Thompson, the Secretary of Health and Human Services.

DR. ZUBELDIA: Thank you, Stanley. I think that's great news, at least for the complementary and alternative medicine that are covered by this code set, at least they can immediately start testing the use of the code set.

But as a general understanding for NCVHS, we still want to hold the hearings and understand better what's the use of the complementary and alternative code sets today. So with that, I would like to start with our panel, and I would ask that the panel members introduce themselves first, and then, the other in which the panel members will speak is Richard Nahin first, then Konrad Kail, Carol Bickford, Bruce Milliman, and the rest are in the second panel. So if you want to introduce yourselves and then, Dr. Nahin.

DR. NAHIN: I'm Richard Nahin with the National Center for Complementary and Alternative Medicine, National Institutes of Health, Department of Health and Human Services. Everyone is going to be introducing themselves now right? That's what he asked.

DR. ZUBELDIA: Yes, just introductions. Please introduce yourselves.

DR. KAIL: I'm Konrad Kail, I'm a naturopathic physician, I represent the American Association of Naturopathic Medical Colleges which is here in Washington, D.C., and the Southwest College of Naturopathic Medicine and Health Sciences in Tempe, Arizona.

DR. BICKFORD: Carol Bickford, American Nurses Association.

DR. MILLIMAN: I'm Bruce Milliman, I'm a naturopathic physician, representing the American Association of Naturopathic Physicians, which is also here in Washington, D.C.

MR. DUMOFF: My name is Alan Dumoff, I'm an attorney who works to represent alternative medicine practitioners and I'm testifying today as executive committee member of the Integrated Healthcare Policy Consortium.

DR. FREIBERG: My name is Richard Freiberg, I'm a doctor of acupuncture and oriental medicine, representing the Oriental Medical Practitioners.

DR. FAUST: Paul Faust, naturopathic physician, and director of the Chesapeake National Health Center.

DR. CULLITON: I'm Patricia Culliton, director of the Alternative Medicine Division at Hennepin County Medical Center.

DR. ZUBELDIA: Ok, we're going to split the testimony into two parts, first will be Dr. Nahin, and then we'll have the rest of the panel, we'll have a break with questions in between the two panels.

Agenda Item: Introduction to the Topic of the Day "Complementary & Alternative Medicine" - Dr. Nahin

DR. NAHIN: I was asked to give an overview of complementary and alternative medicine to set the background for today's panel. Again, I'm with the National Center for Complementary and Alternative Medicine, which is one of the 27 Institutes that makes up the National Institutes of Health, which is of course itself one of the many agencies that makes of the Department of Health and Human Services.

Just as background, Congress created the National Center for Complementary and Alternative Medicine, which we generally call NNCAM, in 1999. And this language which I have up on the screen here, and I'll read to you, I think very succinctly describes the mission of NNCAM as described by Congress. It says the general purposes of the National Center for Complementary and Alternative Medicine (NCCAM) are the conduct and support of basic and applied research, research training and other programs with respect to identifying, investigating, and validating complementary and alternative treatment, diagnostic, and prevention modalities, disciplines and systems. From this language you can see that NNCAM has been charged by Congress to study all aspects of complementary and alternative medicine across all disease areas, a very wide portfolio.

One of the first things NNCAM did was to decide on a definition of complementary and alternative medicine. If you read the literature or talk to folks, you'll find there are many, many, many different definitions of complementary and alternative medicine, which is generally referred to as CAM. Each of these have their own strengths and weaknesses, however, as a research funding arm of the federal government, we chose to use the following definition. The CAM are those medical and health care practices outside the realm of conventional medicine, which are yet to be validated using scientific methods. And for this definition, complementary treatments we considered are those treatments that are used together with conventional practices, while alternative treatments are those treatments used in place of conventional practices.

Now using this definition you could identify literally hundreds of different treatments, modalities and systems that we would consider complementary and alternative medicine. And on the screen here I've catalogued some of these. What NNCAM has done is to group these very heterogeneous systems of medicines into five broad domains, biological based systems which include diet therapies, herbal products, and other types of dietary supplements; manipulative and body based systems, which include such things as massage and chiropractic; mind-body medicine, which would include yoga, prayer, spirituality, and meditation; whole alternative medical systems, which includes such things as naturopathy and homeopathy, as well as oriental medicine; and energy therapies, which would include such things as reiki, magnet therapy, and qi qong. Now again, there are other ways to divide alternative medicine into other organizations. This particular system allows NNCAM to organize our research portfolio into administratively and scientifically manageable units.

Now another way to think of these very diverse therapies is to picture them lying on a continuum, what I like to call a CAM continuum. And on this continuum those therapies that are on one side of the continuum, in this case the right hand side, are those therapies that are most well studied and most integrated into interdisciplinary health care as we know it today. On the other side of the continuum would be those therapies that are the least integrated into interdisciplinary health care.

Now it's NNCAM's goal to study interventions along this entire continuum, from the least integrated to the most integrated. And through the support of rigorous science we hope to identify those therapies that are safe and effective, and in so doing help move them along the continuum, from the left hand side to the right hand side, until finally we have programs in place to --

MR. BLAIR: Excuse me for just one sec, since I can't see the chart and since there's going to be people on the Internet as well that can't see it, could you just reference where the five different modalities fall on the spectrum?

DR. NAHIN: I'll get to that in a minute. In practice, any given modality can fall anywhere along the continuum, depending on how it's used. And my next slide I'll actually sort of give an example of that. But I just wanted to finish with this slide by saying that we have programs in place to help transition well studied interventions into interdisciplinary health care in standard practice.

Now the next slide, what I've done is I've superimposed on this continuum slide a graph showing the use of Vitamin E at different doses for different conditions. And what I've done is on the most integrated side of the continuum, I have an example of using very low doses of Vitamin E at the RDA level to either prevent or treat Vitamin E deficiencies. And I think most people in this room would agree that this is certainly well integrated into standard care today, the idea of using replacement therapies for vitamin deficiencies.

Then as I move to the less integrated side of the scale, the next example I give is using higher dose of Vitamin E, and there's some evidence suggesting that this higher dose, about 200 mg. per day, might be used to reduce the risk of coronary heart disease. And again, moving down the scale at higher and higher doses, eventually I get to the least integrated side of my example, which would be the use of very high doses Vitamin E, 800 mg. per day or even higher, to increase immune function. And of course most people in this room would consider this to be not well integrated into standard care today.

Now over the last several years NNCAM has used six main criteria to help us evaluate different alternative practices, and help us sort of establish our research agenda. And I'll just read this for those on the Internet. We look at the use of the interventions by the U.S. public, and here we give greatest way to those interventions that are widely used by the U.S. public and less way to those that are used by just a handful of individuals. We look at the public health significance of the disease or condition being treated, giving greatest way to those diseases such as cancer, HIV, or cardiovascular disease that might be associated with high mortality, as well as the diseases associated with chronic disabling morbidity, such as osteoarthritis or depression. We look at whether there's credible preliminary data supporting the intervention, and we look at both the quality and quantity of this data, both from the United States and from other countries. We look at the availability and interest of scientific experts who might be interested in addressing a particular question. We look for at least clinical trials where there are actually individuals who would be willing to be randomized to a conventional or alternative medicine intervention. And finally, of course, we have to look at the cost of a project versus cost of other possible projects we're considering.

Now what I'm going to do for the rest of my time is concentrate on the first of these items, the use by the U.S. public, because I felt that that information would probably be of most value to this panel today as we try to sift through the various types of alternative medicine and whether or not they should be coded under HIPAA.

So NNCAM assesses public use in really five different ways. We look at surveys, both national surveys, regional surveys, as well as surveys at individual clinics or hospitals. We look at marketing and sales data for particular products. We look at the types of queries that come to our own clearinghouse, and we have a very active clearinghouse that's available to the public. We look at information supplied by different alternative medicine association groups, such as the American Chiropractic Association. And finally, we look at information that's provided by health insurers, such as, I have HCFA here, it's now CMS, or Blue Shield and Blue Cross.

On this rather busy slide, what I've done is I've summarized data from six national surveys that have been published in the scientific literature. The first of these surveys was published in 1997, the last was published in 2002. Again, I'll just sort of describe this for those on the Internet. The survey types vary from mail surveys to telephone surveys to actually surveys where the individuals go to households to interview people in the households. The sample size of these surveys varies from 1,000 individuals up to 31,000 individuals. The response rates were all very reasonable, being 60 percent or higher. And then I listed two types of data for these surveys, the percent of the population surveyed using complementary and alternative medicine as a group, under the whole CAM domain, and the percent of the population using CAM providers. And you see that these different surveys asked different questions. Some asked the first question, some asked the second question, very few of them asked both questions.

You can see that in terms of use of CAM by the U.S. public, it varies from about 29 percent in one survey up to a high of 47 percent in another survey, while the use of the population who are using CAM providers is much less, varying from about 8.3 percent in one survey, to up about 19 percent in another survey. And it should be immediately clear from these type of data that the discrepancy between the population using CAM and the population using CAM providers, that most of the people who are using CAM are actually self medicating or some other way not using a learned licensed practitioner, which I think is certainly information this panel has to consider.

In this next slide what I've done is taken data from one survey, by Eisenberg and his colleagues, published in 1998, showing what kind of diseases and conditions alternative medicine is used by the U.S. public. And here what I've listed is the top ten conditions as listed in the Eisenberg survey. The most prevalent condition used was back pain, that's about 11 percent, then neck pain, osteoarthritis, headache, allergies, insomnia, depression, anxiety, GI disorders as a group, and then high blood pressure. High blood pressure was used by about two or three percent of the public.

Now what's interesting about this group of ten is that most of them are chronic debilitating diseases and not acute diseases. And many of them are resistant to conventional treatments. So in effect, people use alternative medicine when they feel that conventional medicine cannot help them. What's also interesting is that the top four conditions, back pain, neck pain, osteoarthritis, and headache, are all involved with chronic pain conditions, so four of the top ten conditions used, reasons the American public uses alternative medicine, is because of chronic pain.

In this next slide, what I've done is I've summarized what types of alternative medicine are used by the U.S. public across these surveys. This is a very busy slide, I'm not going to go through each of these data points. I want to point out some trends to you, though. If you look at the slide you'll see that there's really two, the interventions are really divided into two groups, and again for those on the Internet, I'm listing six interventions, herbal medicine is a group, chiropractic, massage therapy, homeopathy, acupuncture and naturopathy. You'll see that herbal medicine, chiropractic and massage therapy across the surveys is used at a much higher frequency by the U.S. public than homeopathy, acupuncture and naturopathy. Now of course there's some variations across surveys for those who can actually see this slide. For instance, for herbal medicine, the survey's vary from two percent in one survey up to a high of 17 percent in another survey, and a range in between, and for those on the internet, each of these interventions has a similar distribution where some surveys have very different predictions of public use than others. But across the surveys it's clear that certain interventions, such as herbal medicine, are used a lot more than other interventions, such as acupuncture.

There have also been surveys that have looked specifically at the use of dietary supplements and botanicals. And I've listed two of many on this next slide. One survey was published in Journal Herbgram in 2000, another was by Kaufman et al. published in 2002, sample sizes are 2000 and 2600 respectively. And if you look at that slide, and for those who can't see it I'll describe it, what I'm plotting is any use in a given period of time for use of herbal products, as well as the top five products for each of these surveys.

For instance, for Herbgram, they've found that about 24 percent of the U.S. public was using an herbal product within the last year, that was how they asked the question. While for the Kaufman et al. article, they just asked for one week prevalence, they found about 15 percent of the U.S. public had used an herbal product within the last week. In terms of the top five products, they actually had the same top five products, garlic, ginseng, ginkgoboloba(?), St. John's Wort, and Echinacea. But again, there are some variability in the order of these products. For instance in Herbgram, garlic was the most used product while in the Kaufman et al. study ginseng was the most used product. Garlic was used at 15 percent in the Herbgram study, but only about three percent in the Kaufman study, while ginseng was used at about ten percent in the Herbgram study but at about five percent in the Kaufman study.

It's always good when you have divergent sources of data that confirm each other and what I'm showing you in this next slide is sales data that was again, published in Herbgram in 2000. It's showing U.S. sales of herbal products from 1999, and there's 15 products listed on this graph, I'm not going to read them all. But what's interesting is that the top five products in terms of sales, ginkgo, St. John's Wort, ginseng, garlic and Echinacea, were also reported by the U.S. public as being the top five products. In this case the order again is slightly different with ginkgoboloba having, at least in 1999, the higher sales by far at about $150 million dollars in the United States, with Echinacea being the fifth highest, having about $75 million dollars in sales.

Again, another source of data that seems to confirm the use of dietary supplements by the U.S. public is data from our own clearinghouse. What I'm showing here is a listing of the top five requests for information from the clearinghouse for years 2000-2001. The sample size for this was about 3,000 requests total I believe. Unfortunately I don't have the actual numbers or the percentages, I just have the relative ranking. Reading down for those on the Internet, the most requested topic to our clearinghouse was for herbal medicine as a group, followed by diet/nutrition therapies, acupuncture, dietary supplements, MNG-3, which is a supplement used for cancer, gocosman(?) and condriten(?) which are both used for osteoarthritis, PC-SPES which is used for prostate cancer, St. Johns Wort for depression, massage therapy as an intervention, and then soy and soy based products.

And what I've indicated now, just pointing out through asterisks, that of these top ten requests from our clearinghouse, seven of them are actually dietary supplements. So again, it's reinforcing the idea that the public uses dietary supplements, and it seems to me that this is where most of their interest is in terms of alternative medicine as a whole.

What I've put on the screen again, for those on the Internet, is the slide again showing the use of alternative medicine modalities by the U.S. public, and the reason I put it on is because I wanted to emphasize again the variability among modalities. Again, the example being herbal medicine being one of the most highly used types of alternative medicine treatments, and the acupuncture being a less used one. For instance, in one study, of the five studies that looked at the use of acupuncture by the U.S. public, the highest rate of use was only two percent, while the lowest rate of use was .4 percent versus as high as 25 percent we saw in the Herbgram study earlier.

Now what's interesting is the difference in opinion of the public and the medical profession in terms of the use of these products. What I've shown in this next slide is again a compilation of three surveys that queried physicians, M.D.'s in the United States. The surveys queried five different groups of practitioners, medical practitioners, national surveys of pediatricians, national survey of internal medicine doctors, a national survey of family practitioner doctors, a national survey of rheumatologists, and then all physicians who worked at the University of Iowa. And what I've shown here is data for two interventions, acupuncture and herbal medicine, but of course these surveys asked for many more. And what's apparent for those of you who can see the slide, is that physicians seem to think much more highly of acupuncture than they do of herbal medicine. In these slides for those on the Internet, the range of physicians with positive opinions of acupuncture varied from 40 percent up to a high of 60 percent, while for herbal medicine it was in the range of 15 to 25 percent. You can see going back to the other slide, this is exactly reversed of the public's view of alternative medicine, at least for these two interventions.

Now the reason I'm pointing this out is to reinforce to the panel that you're going to get different opinions on coding depending on what group you ask. So I think it's very important that you do reach out to as many communities as you can, because you're going to have to synthesize a lot of different opinions and come up with a final conclusion.

This is data I'm presenting here was a survey from Landmark in 1997, it's actually a survey of HMO's and what kind of services they provide in terms of alternative and complementary medicine. I think the sample size for this was one quarter of all HMO's which were in the United States at that time, I'm not sure what the actual number was, but I think it's about a quarter of them. What you can see from this slide is that it's listing five modalities again, acupuncture, chiropractic, homeopathy, massage, naturopathy. In the slide we're seeing that 30 percent of the HMO's surveyed, and who responded, were supporting some kind of coverage for acupuncture, about 65 percent were supporting some kind of coverage for chiropractic, about four or five percent for homeopathy, about 11 percent for massage therapy, and about two or three percent for naturopathy. So again, this is slightly different than the public's perception of use. And I actually have a question for the providers who are going to be speaking later on. I'm curious to why only two percent of the public at a maximum is using acupuncture, why 30 percent of the HMO's are offering it as a coverage, I just wonder from an economic standpoint the rationale.

This next slide I'm showing is summarizing the licensure of alternative and complementary medicine in the United States. Though just like for conventional medicine, the practice of medicine for alternative medicine is regulated at the state level and not at the federal level. And so what I've done here is I've listed the number of states that currently license or certify the five main types of practitioners for alternative medicine, chiropractic, acupuncture, massage therapy, naturopathy, and homeopathy. It goes from a high of all 50 states licensing chiropractic practitioners, to 42 states licensing acupuncturists, these are non M.D. acupuncturists. 25 states licensing massage therapy or certifying for massage therapy, 11 states and the District of Columbia I believe certifying or licensing naturopaths, but only three states licensing homeopaths. And I believe all three states require that the homeopaths actually be M.D.'s, but I have to check on that.

It's also interesting that a number of states, the Medicare programs for a number of these states actually reimburse to some degree for a number of these different practitioner types. 46 states, the Medicare programs in 46 states currently, at least the last time I looked, were reimbursing for chiropractic care, eight states were reimbursing for acupuncture, one state was reimbursing for homeopathy, and I couldn't find data on massage therapy or naturopathy.

This next slide is summarizing, at least for 1998 data, the numbers of practitioners for these different practitioner groups of alternative medicine providers, as well as estimated dollar amounts that might be associated with these practices. In 1998 this one study estimated that there were about 55,000 licensed chiropractics, with about $8 billion dollars of estimated charges in that year. For massage therapists, there are about a million massage therapists, however, between 150,000 and 200,000 of these are certified, and they had a market of approximately $6 billion dollars. Acupuncturists, these are non-M.D. acupuncturists, in this year there were between 5,000 and 8,000 licensed acupuncturists. In addition in this year there were about 1,000 medical acupuncturists, these are M.D.'s who took usually a course offered by one or two institutions in the United States on how to practice acupuncture. And the cost or the services rendered in that year were between .5 and $1 billion dollars. The study listed that there were about 3,000 practicing homeopaths in the United States, but of these about 500 were M.D.'s, at a total service of about $2 million dollars. And that there were between 1,000 and 3,000 licensed naturopaths, at about $2 million dollars.

Now it's interesting to know that these are not stagnant pools of practitioners and in fact, it appears that the rates of growth to these practices are almost geometric. In this next slide I'm showing, it's from a paper from Cooper et al. 1998 that calculated the present number of acupuncturists, chiropractics, and naturopaths in two years, 1990 and 1995, and then used these data plus some other data that queries to the schools of these three professions, and made projects about numbers of practitioners for the years 2005 and 2015. For instance, for those on the Internet, in 1990 there were approximately, according to this slide, somewhere about 3,000 licensed acupuncturists I would say. But Cooper et al. suggest, project that by 2015 they'll be 40,000 practicing licensed non M.D. acupuncturists. For chiropractics, it went from 1999 a little over 40,000 to a little over 140,000 in the year 2015. And naturopathy, though it's at a much smaller scale because it's licensed in many fewer states, again, the slides shows almost a geometric increase over a 15 year period.

So again, it's clear to me that as the number of practitioners increase in the United States, you'll probably see a trend towards more use of these practitioners, because at least one of the reasons people use something is because they know about it. If you have an acupuncturist down the block you're much more likely to use them than if they're ten miles away.

That's going to close my formal presentation. I intentionally left some time for questions for the panel, and I'd be happy to try to answer anything I can.

DR. ZUBELDIA: Thank you, this has been a fascinating presentation. Thank you very much. I have a question and perhaps some of the other members have questions. Where do the nurse practitioner interventions fit in here? Does the Center study those?

DR. NAHIN: The answer is it depends on what the actual practice is. As you're probably aware, there's a National Institute of Nursing Research at the National Institutes of Health, and so there is some overlap in our portfolios, and we actually do collaborate on some initiatives. Depending on again, on where something would fall on that CAM continuum scale, if it's intervention that's fairly close to becoming part of standard care or perhaps is standard care, then National Institutes of Nursing Research would be much more interested in it. An example of this might be use of biofeedback for individuals who are having urinary incontinence. Biofeedback by itself could be considered an alternative medicine modality defined depending on how it's applied. For that particular condition, because there's actually a vast literature on it, that would fall more under the purview of the National Institute of Nursing Research.

DR. COHN: Richard, first of all, thank you, it's been a wonderful presentation trying to put a lot of information together. I want to make sure, I'm trying to sort of put it all together in my own mind and just want to just check with you if I'm conceptualizing this correctly. It appears that there's, as best I'm looking at your slides, there seem to be sort of two focuses, focuses of activity, one is sort of self medication, and indeed I was thinking about my trip to Costco where I could actually buy gingkoboloba and saw and a variety of other herbal medications in bulk in Costco next to aspirin and other things like that. But then in terms of actual provider services, it really seems to be focused on this issue of pain, either acute or chronic. And once again, is this sort of the correct way to sort of conceptualize?

DR. NAHIN: When you look at it from the national perspective, yes. I mean with big surveys, that's what they find, that people are more interested in looking at chronic disease versus acute disease. If you start looking at specific disease conditions like cancer, or HIV/AIDS, you actually find that people with cancer or HIV/AIDS use alternative medicine at much higher rates than the U.S. public as a whole. I mean some surveys, depending on what survey you look at for HIV/AIDS, 100 percent of the individuals surveyed will say they're using some from of complementary and alternative medicine, but not all that high, maybe between 50 and 100 percent. And cancer is also very high.

So again, when you're getting to conditions such as cancer or HIV/AIDS where standard care may be able to delay the inevitable but they haven't been able to prevent it in many cases, people turn to complementary and alternative medicine at much higher rates.

MR. BLAIR: I really have to ask the question in terms of my own personal experience, and that of my wife. And that is my family has a history of heart disease and I've been trying to do what I can to prevent it, and the thrust of what I'm going to wind up saying is, is as an example, because I'm wondering, I mean I have the perception that I'm not atypical, and that the way I'm using alternative medicine is growing. One of the things that I did when I wound up picking a managed care plan is finding a medical doctor that either also respected or considered alternative medicines, or would work complementary with a practitioner of alternative medicine. And those were the things we found, I seem to know a lot of people that seemed to be doing this same thing, where we're trying to marry the best of both. The types of things that I didn't hear you mention was for example, either people that are trying to control triglycerides, high blood pressure, cholesterol, if they do that with some complementary medicine in addition to traditional medicine, is that an area that is growing? And then another example would be women in middle age with menopause as they're struggling with a lot of those areas where they're beginning to wind up again, using traditional medicine along with complementary medicine to try to manage that transition. And diabetes would be another area. Are these growing areas?

DR. NAHIN: To answer what I think you're asking, in fact the survey data suggest strongly that very few people use only alternative medicine. Most use it in conjunction, -- or who are very sick. You might get chemotherapy, you might also get some herbal supplements and see some naturopath --

MR. BLAIR: Now when you say in conjunction, we are doing it in conjunction where both, we try to do this in conjunction with both practitioners are working in conjunction, is that what you mean by in conjunction or where the practitioners are not working in cooperation?

DR. NAHIN: I know the question you're asking. I don't have the data, I'm not sure if anyone has been tracking that. My impression is that since I've been in this field, over the last seven years, you've been seeing increases in a number of integrative practices, or interdisciplinary practices. While you'll get M.D.'s and different types of alternative medicine providers working together in the same office, I can't give you any numbers, it's just my impression, maybe some of the other panel members will actually have more information on that.

DR. FERRER: Dr. Nahin, that was an excellent presentation. I have a question from sort of a data capture clinical point of view. How many patients are sharing with their sort of conventional clinical physicians the fact that they are using alternative complementary modalities? And how many are not?

DR. NAHIN: Again, if you look at the surveys, it's usually not a whole bunch. One third to one half share is about the average I would think between the surveys. Again, depending on what survey you look at and what particular patient population, you might see a much higher rate. For instance, I believe there was one survey by Berman et al. that were looking at individuals going to pain clinics, specifically individuals going to pain clinics, and there the communication seemed to be much, much higher than the norm. And again, it depends I think for some types of complementary and alternative care, some types of conditions, acupuncture for pain relief for instance, certain groups of M.D.'s, rheumatologists for instance, or people working at pain clinics, seem to have a much more positive attitude and are much more willing to use with alternative practitioners. On the other hand, I think if you were to look at an oncologist, you would find much less communication between an alternative medicine practitioner and the oncologist because there's some views in both communities that the interventions are contrary to each other, that the chemotherapy will actually somehow negate the ability of the herbal medicines or the natural products to work, or that the natural products may somehow interfere with the ability of the chemotherapy to work. And I'm not saying there's evidence one way or another to support either of these views, but within the communities it's been my impression that these are the kind of use you get in terms of cancer, there's much less communication.

DR. FERRER: I just have sort of a follow-up question to that. With regards to if we are sort of parsing out that there's a considerable amount of chronic care, pain management, and alternative medicine practices are offering a therapeutic modality that is well accepted and at least from a volume standpoint people are using, is the Center looking at the use of sort of the pain management, not from a sort of a failed conventional treatment modality, but as an initial treatment modality in a particular sort of caseload?

DR. NAHIN: NNCAM, a large amount of our portfolio is actually looking at the alternative medicine treatments for pain management. Unfortunately, we have to work with an ethical principles for a clinical trial. If there's something that's considered standard care, this judicial review board will usually not allow a study to proceed if you remove this care for any great length of time. For instance, we're doing a large trial now at the University of Maryland looking at the use of acupuncture for treating knee osteoarthritis. But in the study, because NSAD's, Non Steroid Anti-inflammatory Drugs are considered the standard care for osteoarthritis, the patients are allowed to be taking non-steroid anti-inflammatory drugs as part of their treatment, and what is being used as an outcome measure is a reduction in the use of NSAD's. So that if we see in the acupuncture group they're using less conventional medication, that might be considered a positive outcome in the trial.

DR. FITZMAURICE: I'm interested in the graph on the percentage of the population using CAM for specific conditions. I can imagine that you brought in, if you're surveying the population, that you ask them what are you taking, or are you taking X for a particular condition, do you wish to improve the treatment or the prevention of this particular condition? Is that how you ask the question or how the studies have asked the questions? And secondly, do you find insurance claims data useful in either identifying populations or in getting information about the populations use of CAM? Are there enough physician claims or is the problem that a lot of this isn't paid for, it's paid out of pocket and so you have to find the pockets rather than the insurance claims?

DR. NAHIN: Well that fact is and I think you'll hear it on the panel, there certainly are third party payers that are covering some alternative medicine, I actually saw a slide to that effect. And there are investigators who are looking at claims data, and in fact I think one of the panel members from Minnesota is going to be talking about claims data to some extent, at least for acupuncture I believe. So yes, we find that information to be very valuable, but it's just now getting to be analyzed, and there hasn't been too much published on claims data. But you'll start seeing more I think.

MS. GIANNINI: Melinna Giannini, Alternative Link and the Foundation for Integrative Health Care. What we found when we were looking at this is that there's a lot of coverage on the workers' comp and property and casualty side for acupuncture and massage therapy and much less on the health care side, so I think one of the things that needs to be done when you're looking at the data is to divide up what's a health care claim and what's a workers' comp claim.

DR. ZUBELDIA: Thank you. So we're going to move onto the provider panel, and if you want to take your seats around the table, you probably will have to share microphones. But we'd like to start the panel, you have the order I gave you, Konrad Kail, Carol Bickford, Bruce Milliman, Alan Dumoff, Paul Faust, and Patricia Culliton.

Agenda Item: Panel 1 - Providers - Dr. Kail

DR. KAIL: My name is Konrad Kail, I'm a naturopathic physician, and I'm also a certified physician's assistant, so I'm kind of a naturally integrated person that has done both of those sides of the fence and had quite a bit of experience with coding on again, both sides of the fence.

I would like to thank the chairman and the members of the Subcommittee for the opportunity to bring testimony before you. As I said before, I do represent the American Association of Naturopathic Medical Colleges and the Southwest College of Naturopathic Medicine and Health Sciences, where I'm the director of research. I'm also on the Advisory Council to the National Center for Complementary and Alternative Medicine at the NIH, and I thank Richard for his excellent presentation and all his hard work.

My submission discusses the training, licensure, practice, and insurance reimbursement of naturopathic physicians. Naturopathic physicians provide primary health care services to patients of all ages. We utilize conventional diagnostic techniques including physical examination, laboratory evaluation, diagnostic imaging and pathologic diagnosis. Assessment may include determination of nutritional status and toxic burden. Additionally, the patient's mental, emotional, social and spiritual status is evaluated, as well as more conventional history and physical exam and other laboratory techniques.

Traditional naturopathic therapeutics include lifestyle interventions, the prescription of natural medicines of animal, mineral and plant origin, therapeutic diet, homeopathy, physical modalities and counseling. Naturopathic physicians are also trained to provide in office minor surgical procedures, administer vaccinations and prescribe a range of drugs depending on jurisdiction. We refer for evaluation and management by specialists, using the same criteria as conventional primary care providers. Naturopathic physicians meet public health requirements and in utilizing a primary care model, work with a multi-specialty referral network of other providers. A natural evolution of naturopathic care models has resulted in the emergence of integrated clinics, including the full gamut of licensed provider, ND, MD, DO, DC, massage therapists, physician assistants, nurse practitioners, etc.

Because naturopathic services are health care and maintenance services, it is important that insurance issues be discussed. Insurance issues include those of liability insurance for the practitioner, and consumer access to insured care. Washington State is being watched right now because of its directive from its insurance commissioner to cover every category of licensed providers. The states of Hawaii, Arizona and Connecticut also have insurance parity mandates for naturopathic physicians. In the state of Montana the insurance commissioner's policy is that if coverage for primary care is provided, naturopathic physicians must be covered as the law defines them as practicing a primary care system of medicine.

It is important in this time of great concern over health care to remember that conventional medicine is not a health care system, because it focuses on acute interventions and does not effectively prevent or reverse chronic degenerative disease. It is at best a detection and disease management system. Because of this, our health care costs get higher and yet we as a population get sicker. This is why one out of every three Americans is seeking an alternative approach to medicine. A naturopathic physician is a primary care physician who focuses on wellness and disease prevention, thereby making naturopathic medicine a service which has cost effectiveness; making their patients good insurance risks for coverage, because they are concerned with prevention; making naturopathic physicians good risks for professional liability because we have close relationships with our patients, use safe therapies, and are not performing invasive procedures; and making naturopathic physicians a desired part of any managed care system that seeks to assure quality and services while limiting costs.

The majority of state Medicaid programs provide some coverage of alternative therapies for children in low income families, according to a recent study from the University of Michigan. Medicaid representatives from 46 states were interviewed in the study, which reveals that chiropractic is reimbursed in 74 percent of the states, biofeedback in 22 percent, acupuncture in 15 percent, hypnosis in 13 percent, and naturopathy in 11 percent. These states on the average currently spend less than $500,000 dollars a year on alternative therapies for Medicaid recipients. Seven states plan to expand alternative medicine coverage in the next three years.

Utilization data is somewhat skewered, mostly by the type of practitioners. If you remember the slides Dr. Nahin showed, the most populous practitioners out there are chiropractic physicians, acupuncturists and massage therapists, all of which have somewhat a specialty practice which is focused on pain. So naturally, more utilizations since more patients are out that are being covered by third party payers, so around utilizations are a little bit skewed in that direction by type of provider. If you look at more primary care services I think you'd find a little bit different perspective. Although utilization information is available, mostly it's proprietary, and not easily shared by third party reimbursers. There are very few demonstration projects that are out there. Recently the NIH did have a call for papers regarding looking at utilization and trying to keep that proprietary so third party reimbursers would be able to contribute data in a better venue. So utilization we don't know a lot about at this point.

Evaluation management as well as procedure codes ideally describe the actual service provided by the provider. It is hoped that an understanding of how these naturopathic physician practice will aid in the code development process undertaken by the Committee. Because naturopathic physicians practice primary care medicine, most of the existing codes are entirely appropriate. The preventive medicine codes best describe much of what we do, although usually not reimbursed by third party payers. Although there are some things that need some modification for very specific modality use, the broad amount of coding that is used by naturopathic physicians don't really need to be changed, a few modifications maybe.

The rest of the information I put before the Committee is a long description of training of naturopathic physicians, where there are licensed organizations you can contact for more information, and the type of practice that might be used in the various states that do license. I think that members of the Committee can use that ancillary information, and further discussion on particulars around codes I'm going to defer to my colleague Dr. Milliman a little bit later in the presentations, but I will entertain any questions.

Thank you very much for the opportunity to testify.

Agenda Item: Panel 1 - Providers - Dr. Bickford

DR. BICKFORD: I'm Carol Bickford from the American Nurses Association, I'm a registered nurse, and in my position at the American Nurses Association I'm responsible for addressing informatics and telehealth initiatives in the Department of Nursing Practice and Policy. I've titled my presentation Integrative Healthcare Services to give a better perspective of how we view our world.

There has been discussion that we are involved in an imploding U.S. health care system, where at least half of the personal bankruptcies are a result of the inability to pay health care bills. Hewlett Associates and UCLA surveys project that the 2003 premiums will run at least 20 percent higher across the board for our health care insurers, which means smaller businesses will pay 30 to 70 percent more for their unchanged coverage, or may elect to not provide health care benefits to their employees, and that is becoming a significant issue in Florida where the majority of the businesses are small businesses. This will result in an uninsured population increasing by 50 percent, so we'll have about 60 million people uninsured.

How do we resolve some of those issues surrounding this imploding health care system? I'm referencing Brian Klepper's work from the Center for Practical Health Care Reform at the website www.practicalhealthreform. He identified the common vision for a solution in helping us resolve this issue with immediate actions which include establishing universal coverage of basic care, and basic care has to be defined, and rebalance of the medical liability which we're certainly seeing as an issue as our traditional clinicians are staging walk-outs to demonstrate the significant increase in the malpractice liability. And nurses are similarly affected as we see increasing malpractice liability charges.

In the longer term Brian Klepper suggests that we need to standardize information technologies, this is not knew, and when available adopt evidence-based best practice guidelines. That's not knew either. Probably of most importance is creating accountability. Are we going to be able to do that if we don't have the data?

When we take a look at the latest Institute of Medicine Report just released talking about the priority areas for national action transforming health care quality, it's been identified that we have an inadequate health care delivery system that fails to implement effective treatments, we have outmoded and poorly designed systems, and we need corrective action to resolve our poor quality of care.

The first recommendation talks about establishing priorities for national action that have to represent the U.S. population's health care needs, has to be across the life span, must be involved in multiple health care settings, and should involve many types of health care professionals. Topics we are talking about today, across the life span, across the health care settings, with multiple professionals providing the health care, or even the health care consumer. There needs to be an extension across the full spectrum of health care, not disease. We have to keep people well and maximize the overall health. We need to provide treatment to cure disease and health problems, assist the chronically ill to live longer, more productive and comfortable lives, and provide dignified end of life care respectful of values and preferences of individuals and their families.

Recommendation number two from that same report talks about the need for criteria for evidence-based approach in this initiative. Looking at the impact, what's the extent of the burden on the patients, the families, the communities and societies? How can we improve this? What's the extent of the gap between current practice and evidence-based practice? What about inclusiveness? What's the relevance to the broad range of individuals? The consumers, not the clinicians.

Recommendation number five talks about the importance of data collection in the priority areas. We have to go beyond usual reliance of disease and procedure based information to include data on health and functioning. We need to cover relevant demographic and regional groups to identify disparities in care, those who pay data are reported, if you're going through the insurance plans or Medicare. What about the rest of us who pay out of our pocket? What about those who can't pay? Be consistent within and across categories for accurate assessment and comparison of quality enhancement efforts.

In looking at that recent IOM Report, the priority areas were identified as preventive care, behavioral health, chronic conditions, end of life, children and adolescents, and inpatient/surgical care. These are all consistent with the HealthePeople 2010 requirement to work towards the goal of increasing quality and years of healthy life, and goal number two of eliminating health disparities. When you compare the priority areas in the most recent IOM Report, they're very consistent with the 2010 focus areas.

Well, integrative health care is one of the solutions. When we take a look at our nursing population, we have 2.2 million registered nurses that are considered employed based on a national sample survey of 2000. The average age is 45 years, so we are suffering from the same ailments as our population. The annual salary is listed as $46,782 dollars, but in real dollars that's only $23,000 per year, that's in light of inflation. We haven't earned any more than we did in the late '70's. 59 percent of our registered nurses work in hospital settings. And 157,000 of those nursed are identified as Advanced Practice Registered Nurses. Now I provide that information because the Advanced Practice Registered Nurse is the nurse population who are most usually involved in utilization of CPT and ICD codes in their advanced practice. The 59 percent of nurses working in a hospital are not involved in coding, that's being accomplished through the coding system downstairs, the resident on the admitting diagnosis, the discharge, and whatever procedures the first one or two. And the total care is not reported, there aren't any coding systems to reflect that in the reporting data going out to CMS, to the states, whatever. So that hidden population of our care delivery initiatives is not recorded.

Similar scenario holds true for the Advance Practice Nurse, because those reporting codes may be bundled within the practice, they may not be independent practitioners.

I wanted to provide you with our draft definition of nursing, which is out for public comment at this point in time to give you an understanding of where we are coming from and the importance of integrative health care initiatives in our environment. Nursing is the prevention of illness, the alleviation of suffering, and the protection, promotion and restoration of health in the care of individuals, families, groups, communities and populations. Notice the prevention of illness, alleviation of suffering, protection, promotion, restoration of health. The code sets that exist today don't reflect those concepts.

I provide for you nursing's practice framework. We look at the components of assessment, diagnosis or problem definition, outcomes identification, planning, implementation and evaluation. And the evaluation includes how are we progressing towards obtaining the outcomes. We look at all of these components in our practice. Not all of these are contained in our coding systems that are currently recognized in HIPAA standard sets.

When we talk about implementation in practice, that involves coordination of care, health teaching, health promotion, consultation, and for our Advanced Practice Nurses, prescriptive authority and treatment. How many of our current codes include that information?

Nursing has identified supporting terminologies that reflect the diagnosis, interventions, and outcomes. The existing terminology of ICD-9 and CPT are inadequate because of their disease and pathology model. The American Nurses Association has the recognition program and to date we have 13 recognized terminologies to support nursing practice. Our focus is on planning, care delivery process, outcomes, not reimbursement.

I've provided you with an integrative health care services scenarios from our registered nurses who are in practice. A clinician provides modalities in conjunction with counseling for a client with a DMS-IV diagnosis. That person can only code and bill for the counseling, although they've included integrative therapies in that one hour visit. Clients are referred by another clinician for a prescriptive integrative health care services. The consumer has to pay, the insurance companies and Medicare will not pay. A client receives integrative health care services for self-healing, relaxation, stress management, pain reduction or pain relief, self-pay is the only option. A clinician reduces fees or identifies another strategy for reimbursement, using barter or some other mechanism. Our clinicians are being paid $35 to $50 dollars an hour for their services for integrative therapies, and this is client pay, it's not reimbursed.

When we talk about our health care scenarios using integrative health care, we have a primary care clinic service for under insured and uninsured. There may be a sliding scale integrated, any therapy that might be reimbursed is under the E & M and it's based on time. The third party payers haven't a clue about what's actually occurring. Our patients or clients are seeking services for pain reduction or interventions that will allow them to just keep going.

A client by the name of Roger who had Hodgkin's Disease and was treated with extensive radiation therapy. He is surviving three years after he started his decline because of his integrative health care services. Pain was tremendous, his radiation sequele(?) were awful, but he is able to keep going by paying out of his pocket for his integrative health care services.

Our nurses are using therapeutic touch, reiki, imagery and visualization, aromatherapy, and reflexology. Some are engaged in healing touch, some are doing herbal therapy, some are acupuncturists. And I refer to you the infusion therapy presentation of April, where the infusion services are not adequately supported, that would be for nutrition as well as chemotherapy.

What are the issues? Who's doing it? What are they doing? How are they doing it? Where, when and why? We don't have the answers, we don't have code sets to support that. We're not able to talk about the outcomes. We can't address the best practices, we can't address the costs. And frighteningly, we are now dealing with increasing regulation component. Our nurses who are certified in some of these modalities are shaking because people down the street are opening their shingles, they have no professional preparation, and they are getting clients, they are treating without regulatory control.

I'm going to stop my presentation at this point, addressing the fact that we have no way to code what we are doing in our practice. It's not under E & M, it doesn't cover it.

Agenda Item: Panel 1 - Providers - Dr. Milliman

DR. MILLIMAN: Chairman Cohn, vice chairman Blair, other members of the Subcommittee, thank you for the opportunity to address you this morning on behalf of the American Association of Naturopathic Physicians. As I said, my name is Bruce Milliman, and I'm a naturopathic physician in private practice in Seattle, Washington, where I have practiced for more than the last 20 years, in a multidisciplinary office setting with one of the oldest integrated medical centers in the United States. The office in which I work is comprised of a number of different practitioner types, including licensed acupuncturists, naturopathic and medical physicians, massage practitioners, licensed psychologists and others. The M.D. component for those of you who are particularly interested is currently two family practice doctors and one internist, all of who have conventional type practices. However, we all work together under one roof and do frequently, that means hourly, not once or twice a week or every couple of hours, would find ourselves back and forth across the hall co-managing care when it's to the benefit of the patient. Which I might say is quite frequent, where either I will seek the aid of one of the other practitioner types, not infrequently a medical doctor, or they, that is one of the M.D.'s might seek my advice as to what might be a safe and effective alternative treatment where the conventional treatment either has failed, wasn't tolerated, or it was rejected for religious or philosophical reasons.

I'm also the chair of the Insurance and Reimbursement Committee of the AANP, if I may call it that instead of repeating the words, I'm an associate professor currently on the adjunct faculty at Bastyr University, which I want to speak just a word about. Bastyr University of Natural Health Science located in the great state of Washington, the other Washington, when I joined the college in 1970 something, it had 30 students. It now has over 1500. It was in a room, it is now on a 40 acre campus. And of those 1500 students currently enrolled in Bastyr University, 550 of them are enrolled in the naturopathic medical school. We currently have 600 licensed naturopathic physicians practicing in Washington State.

I wanted to also sidebar in this because Washington State seems to be sort of a pioneer state, the great Northwest, along with Oregon, Alaska, Montana, Utah, Arizona, Hawaii, others, where naturopathic physicians are licensed. My practice is approximately 60 percent managed care, where I as the primary care provider and gatekeeper for the insurer help to as any other primary care provider would, orchestrate appropriate care for patients suffering from acute and chronic conditions. I wanted to clarify this for the benefit of the panels so that you can understand the range of responsibilities that fall under the aegis of a full service physician level provider who doesn't happen to have an M.D. after their name any more than an osteopath does. And in other states where we have not yet enjoyed I would so the very proactive and forward thinking that exists in the state of Washington and has for approximately for the last century, that's how long we've been licensed approximately. That it helps to explain some of the disparities that were pointed out in earlier discussions.

I'm also a member of the Integrated Health Care Policy Consortium Coding Taskforce, which has brought these issues under studies, and about which you will be hearing more in detail from another taskforce member and executive committee member Alan Dumoff shortly.

The American Association of Naturopathic Physicians, along with its sister organization in Canada, the Canadian Naturopathic Association are the only national organizations in North America which exclusively represent licensed naturopathic physicians. Those are doctors who have graduated from a four to five year curriculum at an accredited medical school, naturopathic medical school. And I note that in some of the ancillary materials that you'll read that it's stated that N.D.'s can complete their curriculum at three to four years. I think that that's a bit dated, I know being closely connected with the academic institution in Washington State, no student can complete it in three years, few can complete it in four years because of the growing amount of medical data, both conventional and the emerging fields that were alluded to early, many of the students have to attend for five years. Fortunately they're able to do so on federally funded student loans because they are accredited universities, but you should cognize the depth and breadth of the education that the people who are addressing you and are addressing this issue represent and understand why the profession is growing so rapidly.

We're pleased that the Secretary has authorized a pilot study of Alternative Links' ABC code set. We also applaud the fact that the CPT evaluation and management workgroup, about which I was appraised recently. A sidebar, I've sat for the last five or six years on the Washington State Health Care Authority's Outpatient Prospective Payment System Technical Advisory Group, and we had a very good presentation on the E & M Workgroup's most recent Power Point presentation. We're applauding the fact that they are currently assessing and making recommendations for the physician work components of the E & M codes. These advances are encouraging, and it is hoped that the Subcommittee will work to ensure autonomy for the editorial panel process from undue influence by any single interest group, and that plurality of representation on any code set editorial panel or panels and related advisory groups will be assured.

Naturopathic medical services, as taught in the five accredited naturopathic medical colleges in North America, and as practiced by licensed naturopathic physicians, are generally describable as earlier stated, via current procedural terminology, in terms of both the evaluation and management as well as the procedural code components. Difficulties encountered in CPT coding by N.D.'s are similar to those encountered by M.D.'s. Naturopathic medical services are billed for by utilization by both ICD-9 and CPT on a standard HCFA 1500. Most primary and specialty naturopathic medical services are reimbursed for by third party payers in jurisdictions, such as that of the state of Washington, where N.D.'s are contracted providers. N.D.'s would like to participate in further revision of the E & M codes as already undertaken by the CPT E & M Workgroup. As the body of research mounts in support of nutritional counseling, lifestyle modification and exercise education as appropriate interventions for chronic dysfunction and disease and as alternatives to long-standing drug therapy, many of these interventions, perhaps formerly underutilized, are beginning to look more mainstream now than ever before, and are showing their true value. The public is attuned to this and embraces these therapies that are more safely available under licensed care.

Contemporary medical practices are thus beginning to include more interventions commonly used in naturopathic and other CAM forms of medicine. For example, in light of the recent negative hormone replacement study for post- menopausal women, there is an increase in the recommendation of Black Cohosh, Cimicifuga racemosa, by medical doctors. Only months ago, a recommendation to use an herb for the treatment of menopausal syndrome in a conventional setting would have been strongly resisted, yet these types of interventions have been part of our professional practice for many decades. We'd like to assist in reflecting these and other developments into the descriptors for physician work in E & M. For those of you that are interested, I brought the most recent article of the American Family Physician and also a copy of the American Journal of Obstetrics and Gynecology, August 2001, both of which allude to the Black Cohosh issue, which interestingly has no receptor site affinity that does show quite a lot of efficaciousness for dealing with the symptoms of menopausal syndrome, and no evidentiary base for helping with prevention of osteoporosis.

The existing components in E & M of history of presenting illness, physical exam and complexity may be inadequate to describe the emerging nature of physician work in this era, especially as it relates to the following components, increasingly common in clinical practice, for N.D.'s, M.D.'s, and primary and specialty care, to wit, patient advocacy through shared decision making and condition specific education via interpretation of laboratory and other reports, records and studies. Stress management counseling, exercise and physical education, spiritual and relationship counseling, nutritional evaluation and counseling, and the increasing use of electronic communication as a frequent mechanism of patient follow-up care. The foregoing is illustrative of the importance of the reexamining and possibly redefining the components of E & M in light of the evolving nature of physician work in current clinical practice.

Multiple system disease, chronic pain and fatigue, epidemic obesity and diabetes are but a few of the emerging trends in the health of our citizens. These and other conditions did not have the prevalence and demographic dominance when current CPT descriptors were developed for E & M. The resulting complexity of medical decision making and coordination of care with new and emerging modalities of management are accompanied by new coding challenges. Naturopathic medical education, perhaps more so than any other disciplines, includes familiarization with, training in, and appropriate utilization of all of the specific therapies, modalities, and complete medical systems currently defined as complementary and alternative medicine, a.k.a. CAM.

I'd like to sidebar again here, and point out why I use the term specific therapies modalities and systems. A therapy is a particular item in naturopathic medicine, for example, the herb that I mentioned, Black Cohosh for menopausal syndrome, or hormone replacement therapy. A modality is a collection of therapies gathered together under one similar umbrella, for example botanical medicine or nutritional supplementation. A system of medicine, such as naturopathic medicine, which is eclectic or iervetic(?) medicine, or oriental medicine, are entire comprehensive systems of medicine with their own philosophy and school of thought and sets of practices, whether defined scientifically in modern Western terms or not.

The types of therapies that I'm alluding to include, but aren't limited to, botanical medicine, homeopathy, hydrotherapy, therapeutic nutrition, acupuncture and oriental medicine, manipulation, massage therapy, and natural childbirth. We would like to aid in the development of parameters to help code for the coordination and delivery of care that may utilization these therapies, modalities and systems of health care. The exact definitions of the components of such care must come from the naturopathic profession as well as from each of the other relevant professions that have specific therapy, modality and system training.

The AANP supports the planned pilot study of the Alternative Link's ABC code set as well as the CPT update of the descriptors for documenting physician work and E & M coding. Our profession regards it as critical that autonomy for the editorial process, that is code development, management, evaluation and retirement, be encouraged by the Subcommittee to the greatest extent possible. We believe that it is equally important that the representation on advisory committees and editorial panels become more truly representative of the provider groups affected by the codes, including naturopathic physicians, and needs your fullest attention and action.

Our profession has participated and is participating in numerous studies, by the way, both on outcomes and utilization. Some of these are supported by grants as already stated from the National Institutes of Health, Center for Complementary and Alternative Medicine, and are carried out by naturopathic medical schools. Others have been completed or are underway at conventional medical institutions. Some naturopathic physicians enlist the aid of medical students and recent graduates from naturopathic medical schools because we do get a disproportionately small share of the research budget, even in light of the smaller number of practitioners. So many of us as private practitioners self fund our research, and gather the data for office based research is what I had said, much of which is published in peer review literature.

I'm sorry to have been so long winded, I hope that this information is helpful to the Subcommittee in making its deliberations and recommendations to the Secretary, and we thank you for the invitation to submit testimony. Thank you very much.

Agenda Item: Panel 1 - Providers - Mr. Dumoff

MR. DUMOFF: Chairman Cohn, vice chairman Blair and members of the Subcommittee, good morning. My name is Alan Dumoff, and I should start by being clear that while I'm listed as an N.D. in your materials, and while many of my colleagues think I suffer from a delusion that I'm a naturopathic doctor, I actually am a practicing attorney focusing on complementary issues, including coding issues, with many of my clients. Today I'm speaking as an executive committee member of the Integrated Healthcare Policy Consortium (IHPC), and I thank you all for inviting me to testify today.

The IHPC is a national working group of the Collaboration for Healthcare Renewal Foundation, and is charged with articulating and advocating public policy that will improve access to high quality integrated health care services. This working group was founded early last year on the heels of a groundbreaking summit at Georgetown University that was co-hosted by the American Association for Health Freedom, Georgetown University, and Bastyr University. This summit was convened to identify common ground we believe exists among a wide range of healthcare stakeholders, representing both conventional and CAM services. Representatives of nearly 60 national organizations spent several days exploring what an integrated healthcare system would look like, and how to achieve it through a defined national policy framework. What resulted is remarkable, and expressed in a series of consensus recommendations in a report, the "National Policy Dialogue to Advance Integrated Healthcare: Finding Common Ground". This report is available to you today, it's over on the table, and I've appended to my testimony both the list of IHPC participants and you'll also find on the back page of this report a list of all the organizations that participated in that policy dialogue.

As IHPC's policy agenda was being crafted, we recognized coding as having profound impacts on our constituent organizations. Gaps in CPT code sets for CAM procedures were of significant concern. The comprehensive coverage and precision required for accurate communication of the provider/patient encounter is simply not available under the CPT system. In addition, the lack of representation by licensed CAM professions on CPT panels seems unilaterally biased. The proposed ABC code set developed by Alternative Link, while an important effort to address this identified need, introduced a new set of concerns, including uncertain effects from coding CAM services for a separate code set from CPT biomedical codes. Consequently, IHPC seated a taskforce to explore the inequities in the current system. Members of this task force met with representatives of CPT and AltLink two weeks ago. These were productive sessions, and we are encouraged by the prospects of working with each organization to enhance public health, or overcoming barriers to integrated and CAM services.

We wish to focus today on the following four points. One, there are significant gaps in available code sets that hinder the proper reporting, and indeed practice, of integrative and CAM therapies.

Two, difficulties in coding arise not merely from an absence of codes for many CAM procedures, but from the guidelines, the structure, and the application of codes to health information infrastructure, such as Relative Value Unit scales.

Three, the development of codes that properly describe CAM services therefore requires far greater representation by the professional associations whose members deliver this care.

And fourth, IHPC is in an excellent position and available to further this needed representation.

IHPC is gratified that this Subcommittee has taken note that a large and vital universe of health care services cannot be reported with existing code sets. Numerous widely practiced CAM procedures with demonstrable clinical efficacy offer legitimate cost effective alternatives to mainstream care, yet are represented poorly, if at all. Many procedures simply have no code, including oriental medicine techniques such as cupping, chiropractic therapies such as closed joint adjustments, or bodywork therapies such as Asian Massage. Physicians also face numerous gaps in codes, such as allergen immunotherapies aimed at alleviating non-IgE mediated sensitivities. Coding difficulties faced by CAM practitioners, nurses and integrated physicians are often much more difficult, however, than simple gaps, and arise from uncertainly as to whether a service can be fairly represented by a code written for a biomedical procedure. This can be as simple as whether an acupuncturist is needling what's called an "Ah Shi" point can bill for a trigger point therapy, 20552, or as complex as determining the E & M level that should be billed by practitioners, such as naturopathic or chiropractic physicians, or even medical physician using approaches to care based on different theories of health and healing relationship. These encounters are different in fundamental ways from those upon the biomedical views which E & M guidelines are based.

The Subcommittee's active role in ensuring more inclusive and accurate codes is a welcome one. It is important in this mission to recognize that ensuring accurate descriptors is not merely a matter of filling in the blanks for missing procedures. Editorial development must provide an inclusive and pluralistic approach to writing these guidelines under which codes are used. Decisions about E & M, bundling of procedures, and coding categories affect collection of outcome data and reimbursement. Assessment of RVU's, same day rules, etc., must have full representation of the affected professions.

The ability to submit CPT code requests, which is the current avenue, is a woefully inadequate means of representation, as these guidelines have enormous impact and must be addressed by those delivering care. The determination, for example, that an E & M component is bundled in a chiropractic manipulation, bars chiropractors from correctly representing services within their training and scope. Practitioners conducting a searching inquiry into patient complaints of fatigue spend a considerable time exploring some of the more complex etiologies in medicine but are constrained "under code" due to perceived lack of morbidity. It is not an issue of provincial interest to seek guidelines based upon these broader views of care, as those who pay for these services need to understand the components of these encounters.

The professional groups that are here can best describe the actual gapes. As a collaborative effort assisting professions and furthering support of national policies, IHPC can best comment here on the minimum requirements for effective code development.

As a first critical step, IHPC supports the Secretary's decision to authorize a demonstration project for ABC codes. The work AltLink has done in bringing this issue to the Secretary's attention and in launching an initial set of CAM codes is highly significant. Their process most closely matches the criteria IHPC has identified for representative coding sets and should be tested. Providers and payers share an interest in understanding the benefits these codes may offer and to learn of policy implications or operational problems that may exist. IHPC also supports the Subcommittee's efforts to generate greater responsiveness on the part of the CPT editorial panel. The AMA CPT committee leadership articulated in our meeting their understanding of the need to expand professional policy representation. This process must be reinforced at the federal level. Whether these two code sets remain independent or are merged, concurrent development of CPT and ABC are critical.

In sum, any editorial process that develops codes for CAM services should be representative, transparent, and allow autonomous control by each profession. By representative we mean that the participation should be inclusive, pluralistic, heterogeneous and even-handed. All professions licensed in any state and offering services that can be billed to a third party should have a seat on the process. HIPAA has moved the threshold of participation from the current CPT requirement for Medicare reimbursable services to the more inclusive standard of practitioners who submit claims to any third party. This is a sea change, bringing many more people to the table and we encourage the Subcommittee to ensure the use of this yardstick for participation.

There are a number of complex issues in identifying proper representatives. Deciding whether to include associations representing specialties within medicine, such as the American Academy of Environmental Medicine, and modalities of care offered by a variety of professions, such as nutritional or herbal consultation, requires understanding a tapestry of organizations. Some professions are represented by groups with different views, occasionally giving rise to difficulties with state regulation. Massage and acupuncture, for example, are represented by many association with varying definitions of practice. IHPC members have significant experience in moving CAM constituencies toward consensus, and we offer this expertise to the Subcommittee, to AMA, and to AltLink Foundation.

By transparent we mean that the process must be accountable to each of the professions, and the deliberative process available to all. While the CPT process is not open to the public, Michael Bebee, director of the CPT Editorial Services, has agreed to review and provide IHPC with requested codes for CAM services to determine whether there have been such requests and if so, why they've been rejected. This is an important step in the right direction. Given that the healing arts are much broader than the interest historically represented by AMA's political and professional process, the potential conflicts of interest between AMA as the home of CPT and health professions with alternative approaches must be closely managed. The business pressures applied AltLink's product, and the recognition here of these needs are vital parts of growing a more transparent process.

And by autonomous, we mean that the profession should have reasonable ability to determine descriptors for their own services. Code decisions need to be made with the participation of professions delivering care rather than by allopathic medicine as one profession in a dominant position among many.

In addition to these concerns, IHPC appreciates this opportunity to briefly address some of the issues regarding CAM procedural codes. I will skip in my written testimony some of the examples regarding the lack of granularity in codes and just urge the Committee to look at some of the things we've offered as reasons why we need more specificity regarding CAM.

I do want to note a critical issue impacted by code design is that it's important that determinations of RVU's be equitable. We are concerned that distinct codes for biomedicine and CAM could create separate and inferior pay structures for CAM services. While we commend AltLink for its initial efforts at addressing the issue of equality in reimbursement, we urge the Subcommittee to recommend that regulatory language ensure that studies of time, skill, and practice investments are equivalent and not undervalue CAM services.

Finally, a central issue in this process is the threshold for code adoption. Current CPT policy requires that a suggested code be supported in the literature. The extent to which the CPT process can accurately define minimal levels of evidence for CAM procedures is very questionable. While many CAM procedures have invalidated in peer review literature, outcomes tracking may be more effective in evaluating cost and clinical effectiveness. AltLink takes a different approach seeking a comprehensive listing of procedures to ensure tracking outcomes without an a priori determination of value. This approach may offer an important strategy in learning how CAM can be fully evaluated.

There remains a countervailing concern, however, that a separate code set may negatively impact investments and payments for CAM services. This concern is heightened where codes for CAM services may not have met any initial threshold of evidence. In any event, if these code sets are eventually integrated, the tension between the CPT and the ABC code thresholds will have to be resolved. It is critical that this issue be address head on, as the relegation of ABC codes to Category III status is not an acceptable solution.

These issues have all been part of our continuing dialogue with the CPT staff and AltLink. Our participating organizations offer their expertise to assist in finding solutions to these issues. Our intention is to work with the Subcommittee, as well as CPT and AltLink, by offering a central body with which to work with this diverse community of integrated and CAM practitioners.

I thank you for the opportunity to share our thoughts and to go a few minutes over, I appreciate your attention. Thank you.

Agenda Item: Panel 1 - Providers - Dr. Faust

DR. FAUST: Chairman Cohn, vice chairman Blair, and members of the Subcommittee, thank you for the opportunity to address you this morning. My name is Paul Faust, and I'm a naturopathic physician in private practice in Towson, Maryland. I'm also a vice president of the Maryland Association of Naturopathic Physicians and a member of the American Association of Naturopathic Physicians.

I've presented lectures on the philosophy and practice of naturopathic medicine at Johns Hopkins University and the University of Maryland School of Medicine. This submission discusses coding for naturopathic medical services in Maryland, which is representative of the overwhelming majority of states that do not regulate or license the practice of naturopathic medicine. I plan to cover the following key areas, certification, coding and barriers to its implementation, insurance coverage and reimbursement, and the need for greater parity for greater health care.

Regarding certification. As I said, I'm a licensed naturopathic physician, but only in the state of Washington. I'm not a licensed physician in the state of Maryland, since this state does not currently offer licensure for naturopathic physicians. Therefore, I am unable to contract with insurance carriers in Maryland, or submit for third party payment. My patients are not able to receive insurance reimbursement for my services. In addition, they incur additional health care costs, because I'm not able to order even routine laboratory tests, as I do have the authority in Washington. This results in my patients paying for office visits to conventional providers for this purpose.

With regards to coding and the barriers to its implementation. I do not provide any ICD-9 or CPT codes for my naturopathic services, since these collectively might imply providing a medical diagnosis, providing and practicing medicine, and I'm unsure whether I risk state censure by utilizing these codes. In contrast, the use of CPT codes in Washington and other licensed states is necessary. This confusion and potential legal risk due to providing naturopathic services in a state which has not defined a license for naturopathic physicians causes me great distress and uncertainty due to the potential for liability.

I do carry professional liability insurance for my services, and limit my practice to the scope of my education, training, and Washington State license. In addition, I voluntarily restrict the scope of my practice even further, to exclude the following services, which I am authorized to provide in the state of Washington. For example, physical exams such as breast, pelvic and rectal; prescriptions for barrier contraceptive devices; intramuscular nutrient administration; ordering and interpreting diagnostic procedures, such as clinical lab tests, ultrasound, x-ray, and electrocardiogram; minor surgery and pharmaceutical drug prescription, as per our granted drug formulary. These restrictions to my scope of practice degrade the quality of naturopathic care available, and increase the overall health care costs to the average consumer. Authority to practice has real impact on access to, and delivery of, naturopathic medical services. My patients want to be able to choose from both conventional and naturopathic medical services, and they want assurances that practitioners are qualified.

With regard to insurance coverage and reimbursement. For billing purposes, I provide an invoice for naturopathic consultations, simply based on the length of time of the appointment. My fees for services are paid out of pocket by the consumer, even though most of my patients have insurance for conventional health care. Coverage of and reimbursement for most health care services are linked to a provider's ability to furnish services legally within a scope of the practice. This legal authority to practice is given by the state in which services are provided. Even if insurers are interested in covering safe, cost effective, naturopathic interventions, it cannot do so unless there are properly licensed practitioners in a state. State laws that establish professional standing protect the public by ensuring that covered health benefits are provided by qualified practitioners, whose services should meet recognized standards of care. In the absence of such laws, health insurers would be at increased risk of liability if an adverse event occurred.

Naturopathic physicians qualified to furnish safe, beneficial services for which insurance companies are willing to pay, should have the ability to practice legally in their state, just as conventional practitioners do today. Today's health care system should not be prejudiced toward any philosophy of health care, but give equitable consideration to safe and efficacious interventions for both conventional health care and naturopathic medical services.

I'm very interested in the collaboration and integration of naturopathic medical services with conventional health care providers. I frequently co-manage care with other licensed health care providers, including medical doctors, osteopathic doctors, chiropractors, acupuncturists, and counselors when it's to the benefit of the patient. However, this does present some challenges, since licensed providers may not make official referrals within the current Maryland health care systems. I receive many unofficial referrals from conventional physicians, and even have many physicians and their families as patients.

I also regularly train conventional physicians in the philosophy and practice of naturopathic medicine, by having them observe and participate in the services provided in my practice. In addition, I provide preceptorships for naturopathic medical students from the four accredited naturopathic schools in the United States, and I also provide elective training in CAM practices for fourth year medical students from the University of Maryland School of Medicine. I've tried several times to establish an integrative health center in Maryland with conventional doctors, however, the professional license for medical doctors in Maryland prohibits them from sharing patients with an unlicensed provider. I've also been invited by the director of the Complementary Center for Healing at the University of Maryland School of Medicine to join their clinical faculty at Kernan Hospital. Unfortunately, we've not been able to proceed, since we're unsure how to code or bill for my services within existing conventional system.

In the health care industry, partnerships are becoming increasingly more common and essential for delivering integrative health care for today's consumer. Good health care requires teamwork among patients, health care practitioners, regulatory bodies, and health insurance providers. The absence of licensing for naturopathic physicians in all states is an obstacle to inclusion in the mainstream health care system, and prohibits the integration of naturopathic medical services into conventional health care.

Currently, there are less than ten naturopathic physicians in the state of Maryland who are members of the American Association of Naturopathic Physicians, graduates of a naturopathic medical college accredited by the CNME, and have passed the naturopathic physicians licensing examination. I'm aware of several other individuals who use the title N.D., naturopathic doctor, naturopathic physician, who have not met these requirements, and may have simply purchased a degree or certificate from an organization with no requirements that students must meet professional educational standards and have supervised clinical training. These two categories represent significant differences in the level and types of training, yet most consumers in the state of Maryland are unaware of these differences. Establishing legal authority for naturopathic physicians to practice in unlicensed states such as Maryland through mandatory licensure, which prohibits the practice of a profession without a license, ultimately protects the public from the inappropriate practice of health care. Licensure also provides opportunities for appropriately trained and qualified health practitioners to offer the full ranges of services from which they are educated, trained, and certified by recognized standard body.

In addition, there are many other significant barriers to public access to naturopathic medical services in Maryland, such as the distribution and availability of local naturopaths.

Regulation and credentialing policies concerning coverage and reimbursement, and the disparity in existing health care delivery system. Quality is important. Since naturopathic medical practices and products are not covered by health insurance programs in unlicensed states, is that access often has been limited to those with higher discretionary income.

In closing, we need to have uniform licensure and regulation of naturopathic physicians for the public's safety and to ensure equal access to health care. Every person has the right to choose freely among safe and effective care or approaches as well as among qualified practitioners who are accountable for their claims and actions and responsive to the persons need.

I hope this information is helpful to the Subcommittee in its deliberations and recommendations to the Secretary. I thank you for the invitation to submit testimony.

Agenda Item: Panel 1 - Providers - Dr. Culliton

DR. CULLITON: Hello. Chairman Cohn, vice chairman Blair, and the rest of the Committee. I appreciate this opportunity. My name is Patricia Culliton, I'm from Minneapolis, Minnesota, and I'm the director of the Alternative Medicine Division at Hennepin Faculty Associates and Hennepin County Medical Center. Additionally, I'm the founder and co-president of the Society for Acupuncture Research, the founder of the National Acupuncture Detoxification Association, and I'm on faculty at the University of Minnesota Academic Health Center, where I teach two courses, an overview course on complementary medical practices and one on mind body techniques.

I've been doing acupuncture research since the early 1980's within the Hennepin system. And in 1987 I was actually hired full time at Hennepin County Medical Center as an acupuncturist to develop research and some clinical protocols. Over the years, the alternative medicine division was established in 1993, and I have a little bit of a different take on what I'm going to talk about because I was called in by the administrator of the hospital, the president of HFA, and said we're going to let you to develop a division, an alternative medicine division within the Department of Medicine and within our multi specialty clinic systems, but we're not going to give you a penny and you have to figure out a way to keep yourself alive through either self pay or reimbursements. So I present a little bit of a different situation in that our division was developed fully knowing that we had to offer services that had CPT codes available to us. So I'll go on from there.

In 1993 we did establish the Alternative Medicine Division and in 1997 and again in 2000 we were accredited through the Joint Commission on Accreditation of Health Care Organizations. We were told at that time we were the first integrative or alternative medicine clinic in the United States to achieve that status. We provide service, education, we have medical students and residents and allied health professionals that come through our clinic, and we've done extensive research for almost 20 years, some chiropractic, mostly involved with oriental medicine, both acupuncture and herbal medicine research.

We've developed a database of health status information, demographic and utilization data. Initially when we first, when we first opened we were told we had to develop a database because the concern was about safety of the procedures we were going to offer, and with efficacy probably as a secondary issue. Over the years we have developed that database also to include patterns of utilization, including modalities used, conditions treated, payment sources, and numerous other variables. Since 1997 the ambulatory care clinic of the Alternative Medicine Division has provided 52,477 visits to 4,623 individuals, all of which have been documented with CPT codes and ICD-9 codes. However, during that same time we've provided more than 150,000 patients visits in our off-site public health program initiatives, none of which have been coded or individually billed, but they are paid actually through contractual agreements with various public health facilities.

I wanted to just address some of the other things that have come up. 86.3 percent of those 52,477 visits that we did were related to a pain complaint. 76 percent of them of the musculoskeletal, the remaining being more function or headache disorders. So pain is certainly the most common reason that people come to our clinic, and if I could just address Dr. Nahin's question earlier about why are 30 percent of it third party payers reimbursing for acupuncture and only two percent of American's are using it, for the most part, those 30 percent of reimbursers are paying that 1,000 M.D.'s that are doing acupuncture. And so it's kind of slowly becoming a reimbursement issue for insurance companies, but the reality is the confines of who they will pay for is so limited that it's still a very under reimbursed process.

I listed some of the codes that we use. We have three job categories within our system that provide direct service, chiropractors, acupuncturists and massage therapists. We've developed competencies, job descriptions and scopes of practices, credentialing, privileging, etc., for all of these positions.

Now that first list, Chairman do you want me to read out the names of these codes?

DR. ZUBELDIA: No, you don't need to.

DR. CULLITON: So, initially, I just listed what --

DR. ZUBELDIA: I'm sorry, the only thing I want to point out is that the nature of the codes, you call them CPT codes.

DR. CULLITON: Yes.

DR. ZUBELDIA: It seems to me like CPT codes are five digits.

DR. CULLITON: Some of them have modifiers.

DR. ZUBELDIA: Made up modifiers?

DR. CULLITON: Used within the systems within the state of Minnesota. So these are, the initial ones are basic chiropractic CPT codes and then following that I have the therapy codes that we use for chiropractic therapies as well as acupuncture and massage. Minnesota is one of the states that reimburses, Medicaid reimburses for acupuncture and so for instance, the 97780 is the CPT code, and the WW following that is the modifier to know that this is a Medicaid reimbursement issue.

Complementary and alternative medicine services provided at our clinic and not coded include multiple things, reflexology, reiki, many energy treatments, numerous things relative to acupuncture such as acupuncture moxibustion, acupuncture with electrical stimulation, acupuncture with cupping, magnet therapy, aromatherapy, and many other self care and relaxation techniques. We offer these services specifically as a self pay situation, knowing full well we don't even attempt to try to code or bill insurance companies for those things.

We're part of a large health care organization and our appointment and billing services are used system wide. One of the things that we find very important is that we have integrated charts, we use the same medical chart system wide so physicians in our system know who is being treated and what we are doing and vice versa. Encounter form sheets are generated electronically as each patient presents for care and then are entered as arrived in the system. At the end of each visit the provider completes the encounter form with a listing of the CPT code and the ICD-9 code for each individual. The medical reception staff enter that information on their desktop computers and the information is electronically sent to our billing department.

We received reimbursements from numerous payers including various HMO's, commercial companies, auto insurance, workman's' compensation, and state of Minnesota Medicaid. All three of the job positions we have, acupuncture, chiropractic and massage receive at least some reimbursement for their therapies from various payers. Again, that's to some degree why we have chosen those job classifications. We have had for a while homeopaths, naturopaths, and aromatherapists on staff, and economically we're not able to keep offering those services and offer a reasonable rate of pay for those positions, so we do not at this point offer those services.

The level of reimbursement that we get ranges from zero to 100 percent, but our aggregate rate of reimbursement for 2001 was 57.31 percent and in the first six months of 2002 has been 54.23 percent. I do not really think that our aggregate rate is decreasing, I think that's just a process of the time that it takes to get the reimbursement. I would assume that we would do at least as well as in 2001 if not actually improve our reimbursement rate.

The majority of services we offer are billable under existing CPT codes. As I said this was an intentional planning. Those that do not have CPT codes are billed to the patient directly and noted within our system as self pay. By the way, even though we do have CPT codes for herbal consultations and smoking cessation, to date no carrier has ever reimbursed for those so we bill those as self pay as well.

We are informed of new CPT codes as they become available through our billing department, in fact in 1997, up until 1997 we used to bill acupuncture as using an X code, and then in 1997 a CPT code was assigned to acupuncture.

We have developed a database for tracking utilization, outcomes, referral patterns and safety issues. And each new patient fills out an extensive baseline information that includes the MOS short form 36, a visual analog scale to establish the level of severity of a primary, secondary and tertiary complaint. Every visit an individual has at our clinic is entered in our database with the CPT code or an identifier for non-CPT code modalities, and the ICD-9 codes for that particular service. Periodically, we engage a research assistant to contact a cohort of patients and conduct follow-up interviews, and we have published two outcomes articles, have a third in process right now. Initially when people present they are all asked to sign a consent to research form so we can gather this data, and our outcomes process has been approved through our institutional review board.

Pricing historically has been set through standards of the community. As I noted initially, I'm part of the Hennepin County Medical Center, and one part of our mission statement is to serve the under served, so we actually offer our pricing services for self pay on the low end of the standard of community trying to have as much barrier free access to our services as possible.

Thank you.

Agenda Item: Panel 1 - Providers - Dr. Freiberg

DR. FREIBERG: My name is Richard Freiberg, I'm a licensed doctor of acupuncture and a licensed acupuncture physician in Florida. I'm also vice president and legislative chair of the Florida chapter of the National Guild for Acupuncture and Oriental Medicine. I'd like to thank the chairman and Committee for this opportunity to provide information.

I would refer this Committee to the recently submitted written testimony by three distinguished individuals, namely Dr. Richard Flamont(?), M.D., who serves on the National Institutes of Health Consensus on Alternative Medicine Panel, doctor/professor -- Ping(?), an M.D., Ph.D. from China, world famous Chinese herbalist, specifically treating diseases such as HIV/AIDS, Hepatitis and other auto-immune disease. And Thomas Gustafson, Jr., current Florida attorney and past speaker of the Florida House of Representatives. Subject written testimony is available through the committee staff and there's no need for me to read that into the record.

To address Dr. Nahin's charts on page six, the one on use of individual CAM modalities by survey, additional comparative analysis on quantifying and qualifying services of each provided needs to be accomplished. This would further clarify this chart in a more explanatory perspective. Since 80 percent of the licensed acupuncturists in the United States today are primary care providers, with a wide scope of practice, it includes herbal medicine, massage therapy, homeopathy, needle and non-needle therapies, that this chart doesn't include. That does not exclude other types of practitioners that might also service those modalities.

The chart on page nine regarding HMO's covering specific CAM intervention, the reason why there's an apparent incongruity there is that HMO's cover acupuncture but only include a very small network of minimally trained practitioners who use acupuncture needles adjunctively. Subject networks do not include any licensed acupuncturists. This study should be expanded both by reimbursement and openly by using ABC codes, which would further delineate the practitioners type.

To answer the Committee's questions on reimbursement, Florida licensed acupuncturists, also titled acupuncture physicians, as primary health care providers under the Florida statutes, FS457, provide a full scope of health care services including office visits, lab and imaging tests, acupuncture needle and non-needle therapies, electro-stimulation therapies, heat and cold therapies, various oriental body work therapies, some of which are quite different than massage therapy, internal and external application of Chinese materia medica(?), homeopathy, homeotoxicology, diet and nutrition therapies, exercise therapies, lifestyle counseling, and acupoint injection therapies. Within the AMA's CPT code system, it took from the '70's all the way up to 1998 to finally issue two acupuncture codes, with as I may mention, no relative value units assigned. Without being able to apply a dollar cost factor to a missing RVU, these codes are virtually worthless.

Within Alternative Link's ABC code system, all of Florida acupuncture physicians full scope of practice have been assigned codes with RVU's, thereby allowing the production of worthwhile data collection, with real dollar costs, directly associated with those services. Many practitioners who continue to build CAM services under the acupuncture license using codes that are not specifically assigned, such as CPT codes, thereby are potentially exposing themselves to fraud charges. The practitioners using CPT codes are receiving denials for reimbursement with their explanation of benefits stating and I quote "the insurance policy does not cover these services when provided by this type of provider" meaning that the acupuncturist was not using a code belonging to a code set within CPT.

Other ways payers deny reimbursement, even for the use of acupuncture needles is and I quote "this policy will only cover acupuncture when performed by an M.D., D.O. or P.T." HMO's pretty much totally block the inclusion of well trained licensed acupuncturists even when they include it as a covered benefit. For those practitioners already using ABC codes, we are beginning to see some denials such as "you did not use CPT codes therefore we're denying this payment." CAM services are being increasingly denied, and now we're beginning to see CAM as an exclusion in some of the new Blue Cross/Blue Shield policies, actually being written out of the policy. So licensed acupuncturists in Florida more and more are being denied.

Some PPO's and self-insured will pay only for acupuncture needle usage, but very minor dollar amounts, such as eight dollars or $18 dollars, in part because there are no RVU's, and therefore the payers are able to arbitrarily assign any figure they want and call it usual and customary.

As for the balance of coding and scope of practice therapies, these same payers totally deny reimbursements to licensed acupuncturists in Florida. The same PPO's and self-insureds will reimburse M.D.'s and D.O.'s for the majority of those identical procedures, which are denied for licensed acupuncturists. In coding using ABC codes, we have received several denials from auto PIP carriers, claiming that we didn't use CPT codes. When referred for legal collection, and accusations of restraint of trade, they paid very quickly.

Licensed acupuncturists are usually sole practitioners with no office staff help, and therefore the majority of their claims wind up being dropped or not followed up, they simply give up by the slow reimbursement system. Those of us who have learned the system go through a reasonable appeal process and then refer it for legal collection. With the ABC code system becoming a permanent national standard, number one, all payers will be less inclined to deny reimbursement, and number two, even if there is no reimbursement or small reimbursement, there will be cost data and outcome data collected. These are major considerations.

Last week the World Health Organization held its International Health Care Symposium in Latvia. Once again, the U.S. came in at number 37 out of 140 countries in quality of health care, while it came in as the most expensive in the world, with $5,185 dollars per capita per year, whereas other countries, spending least amount of dollars, came in at 39, very close to the U.S.

Acupuncture and oriental medicine has been embraced world wide as a key international standard of health care. The permanent approval of ABC codes as a national standard would go a long way towards reducing the United States high cost of health care.

I just wanted to also address something that Dr. Milliman was discussing about oriental medicine as being a system of medicine, acupuncture as being both a nomenclature that's used for as the NIH commented in 1997, a family of procedures involving the stimulation of anatomic locations on the skin by a variety of techniques. And at the same time, acupuncture also means the use of acupuncture needles. There is a misnomer there, it's almost like aspirin and aspirin and Kleenex and Kleenex, one designates the family of therapies and the other designates a particular therapy within the group.

The acupuncture community thanks this Committee for allowing us to express these concerns.

DR. ZUBELDIA: Thank you to all the panel for your testimonies. We're running a little bit late. What I would like to do is have a very short break, and then go on to the questions, before we go onto the next panel. So let's have a ten-minute break.

[Brief break.]

DR. COHN: If you could get seated we're going to get started with our second session.

DR. ZUBELDIA: To try to see if we can focus the questions and the comments on the topic that we have which is the coding of complementary and alternative medicine. And I would like to stay away from the topic of who gets paid, how much, and for what. Because those are two different topics and I think that we need to focus on one.

I'm going to ask the first question, two questions. First of all, in Minnesota you said you were using CPT codes, and obviously you're using CPT codes with some exceptional modifiers that are not CPT or HCPCS modifiers, they're Minnesota specific modifiers. And that seems to be working for you. I would like to hear what are your plans and how to call this interventions once HIPAA goes into effect, because you will not be able to use your made up modifiers anymore. And I would like to then hear from the rest of the panel as to what codes you are using today to code your interventions for reimbursement, if you are coding them for reimbursement.

DR. CULLITON: For the most part, we will obviously just have to use the CPT codes that will have approval under, I want to say under acupuncture we have the herbal consultation, that is the made up qualifier as I mentioned earlier, we've never gotten reimbursed for that anyway, so it's not going to hurt us that much to not bill it in that form anymore. And that's actually true with those listed under the massage package, it's extremely rare that anyone would reimburse for those, so we use them as part of our tracking system as to what we're seeing. So we will have to adapt that very soon, adapt some changes.

DR. ZUBELDIA: Do you know how?

DR. CULLITON: Actually, that's, no, I cannot honestly say that, that will be through our billing department.

DR. FEINBERG: I'm Laurie Feinberg, and there was a question about that WW code which is actually a local modifier, and I think the Medicaid people have been working with the HCPCS Committee to get all those local codes converted, so I just wanted to say that although you don't know, there are other people worrying about it.

DR. ZUBELDIA: And those will appear as national NCPCS codes?

DR. FEINBERG: Yes, they will.

MR. BLAIR: When you say converted, are you saying converted --

DR. FEINBERG: To national codes.

MR. BLAIR: Yes, I understand that, but does that mean that if the current HCPCS codes does not identify procedures within alternative medicine, that they will collapse to existing CPT codes or that you're going to be adding new codes to add additional definition specificity to the procedures to accommodate?

DR. FEINBERG: Well, this is really much broader than alternative medicine, what we're doing, so I'm going to speak in a much broader arena, and in fact, the area where we've added the most codes is in behavioral health, and we are adding both codes and in your case the WW was a local modifier. So we've presumably done that, and if you want to make sure, have your folks call your Minnesota Medicaid people and have them check with our folks because it's coming through the Medicaid offices.

DR. ZUBELDIA: You'll be covering that this afternoon?

DR. FEINBERG: If you want me to. It wasn't what I planned to but clearly you can ask me whatever questions you need to.

DR. COHN: Laurie, just to make sure we all have it right here, obviously what I think we're talking about is the fact that 97780 is actually currently a legitimate code, and then the question gets to be is Medicare need something else in the way of a modifier to help them. Is that what you're dealing with?

DR. FEINBERG: No, I believe the people who want to modify are in this case is Medicaid, because unfortunately it's not a Medicare covered benefit, so that when that code comes into Medicare, it just doesn't fit into the benefit structure and is not paid.

DR. COHN: I see, excuse me, this is a Medicaid specific issue then.

DR. FEINBERG: Yes, that's why I asked her to contact Medicaid because Medicaid has been working very closely with the HCPCS National Committee.

MR. BLAIR: The only thing I'm concerned about in what you were just telling us Laurie is that my understanding is that there is an important need for these codes other than just reimbursement through Medicare and Medicaid, like for the ability to facilitate outcomes research and the ability to be able to properly license and reimburse folks outside of the Medicare/Medicaid system. So that's why I was trying to understand whether this was precluding a coding system or whether you were just winding up saying ok, here's how Medicare and Medicaid is going to handle it, but not make it more difficult for coding systems to mature to meet current needs.

DR. FEINBERG: Actually, though, we're trying to become HIPAA compliant, and HIPAA is about the electronic transaction between a provider and their payer, and there may be lots of other systems that are used for outcome research, but these are the sets of codes that have to be HIPAA compliant for transmission to the payer, and so that's really the venue that we're working in now to make everybody HIPAA compliant by the deadline. And actually if you, I'll tell you that there are several people nodding around the room agreeing with what I'm saying, so it's not just my opinion.

MR. BLAIR: No, I wasn't challenging the validity of what you were saying.

DR. ZUBELDIA: Jeff, some of the codes that Minnesota is using, for instance 99201 and 99212 are standard CPT consultation codes, and by putting a modifier made up in Minnesota, modifier 05 or modifier 06, they make them herbal consultations, so it's a, I'm not surprised that nobody will pay on 99201 or 99202, or 212, with the made up modifier because they have no way of knowing what it means. DR. DUMOFF: This is Alan Dumoff. I just wanted to offer a quick example of how else this comes up in terms of local coding. IEDTA Quation(?) therapy is an IV drip that's used that is approved for heavy metal detoxification, but is used quite widely among CAM physicians for treating coronary artery disease. It's