[This Transcript is Unedited]
Hubert Humphrey Building, Room 705A
200 Independence Avenue, S.W.
Washington, DC 20020
Proceedings By:
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.
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.
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.
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.
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.
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.
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.
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.
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 not paid for in that context, so ordinarily you would put a GA modifier on the code, and anticipate notice of non-coverage signed by the patient to be able to bill it. We've had situations where the local Medicare carriers did not understand the whole process, kept cycling the bills back through not understanding why it would be a non-covered service. So we negotiated with the carrier and got actual local different code from the carrier to use when we were billing Quation therapy for that purpose, and that's what we had to do to solve the problem.
DR. ZUBELDIA: Part of the other one's coding.
DR. KAIL: This is Konrad Kail. My office is a multidisciplinary office where we have some people that are nationally certified acupuncturists for instance, and other people that are either less well trained medical doctors or naturopathic physicians that, I mean in acupuncture, not less well trained, excuse my remarks there, I notice some chuckles from the panel. But there's two different uses there. Some of these doctors want to use it as an adjunct, like a physical therapy to another treatment. So, for instance, for low back pain they may be getting a prescription for an ensate(?) or something else as well as manipulation skills or physical therapy, a couple of needles put in the low back for 15 minutes. That doctor might code that as, with some electrical stimulation to it, as electrical stimulation, just leave it as a CPT code. Whereas another doctor that's doing some history, some physical, some pulse taking, and basically does a half hour visit around the acupuncture itself, that usually gets billed out as an office visit based on amount of time, because there's a lot of other stuff there and there's no other indicators to show that this was this plus acupuncture. So in some cases physical therapy code is used basically, in other cases it's a code based on time, just a regular office consultation, and it's used that way because of lack of another way to do it. And that's just one specific instance, but there's a host of those that have to do with very specific therapies that one or another physician might use.
DR. BICKFORD: When I was speaking to our nurse practitioners and clinical nurse specialists in private practice, one nurse identified that she cannot bill or cannot record anything for any purposes because the codes aren't imbedded in her software product, and she would value having the ability to record the diagnosis, which may be a non-ICD, but a nursing diagnosis, does not have the capability to code the outcomes and cannot record her interventions unless she looks at some of the nursing languages that have been recognized because they include the whole gambit. The nurse who is in charge of, is engaged in a group practice in a clinic surveying under served population, uninsured, has an access database that she is using to maintain a record of her care delivery through the coding structure using ABC codes to document because there is no way to record it in the automated system that they're using for their reimbursement billing structures.
DR. ZUBELDIA: And you said that you have 13 different terminologies to do this kind of coding?
DR. BICKFORD: American Nurses Association has recognized 13 terminologies that support nursing practice, some of them have duplicates, have been additions of diagnoses, using the NANDA(?) diagnoses, we have initiatives in place to do the mapping, the computer systems are available to support that terminology, mapping and those relationships. That's not the issue for us, the issue is identification of information systems that support the full display of the diagnosis, the intervention and the outcome, because we look at the whole picture. When our patients are referred to our nurses using CAM, they identify their first visit is mutual goal setting, and their evaluation of the therapies are in conjunction with that patient and practitioner identified goal setting, how is that identified in our current structures and our coding systems and how can we measure the outcomes in relation to that. So we don't have support in our information systems for those of us in nursing with an integrated holistic perspective looking at diagnoses, interventions and outcomes.
DR. ZUBELDIA: So you have different terminologies for diagnosis, for intervention, and for outcomes?
DR. BICKFORD: We do but they are all integrated in systems. For example, the home health care system that Dr. Virginia Saba was working with. We have the diagnosis, there are interventions that can be linked, and then there are outcomes associated with it. The Omaha system has diagnosis, interventions and outcomes identified within the whole system. You can't just pull out pieces of it. We also have interventions that are identified in the Nursing Interventions Classification System, and people say well how come you have so many things, it's because we have different people viewing our world with different clinical entities that we're working with. It's a significant issue in our world but the technology and the advancement in the terminology development and language is making it a very doable environment.
DR. ZUBELDIA: Anybody else?
DR. MILLIMAN: I think I already probably clarified it, but if I didn't, from at least in the states where insurance third party billing is used, procedures that are sort of incidental to the basic patient interactions, be it a primary visit or a return visit, typically are not separately billed as a procedure. For example, if somebody came in, and naturopaths do it too, had a couple of skin tags removed. Conventionally in our arena, that would not be, even that would not be identified as a separate procedure.
So if you understand, I can give you the examples of a lot of naturopathic, uniquely naturopathic procedures that are similarly not separately identified as billable procedures, they're rolled into the evaluation and management code as one of the components of complexity. This is where, I'm not totally clear on the ultimate value or ultimate need from our specific profession's perspective of having a unique and separate billing code set, I'm sorry, code set, whether it's used for billing or data gathering or whatever, utilization outcome studies, it doesn't matter. But the thing is is that if we did that then it would seem to me that there would want to be a broader sort of procedural change that took place within CPT that also was able to capture those kinds of interventions that happen in a more conventional way.
I could give you an example, I think Konrad, Dr. Kail could help me if I get an inappropriate example or one that isn't sufficiently explanatory. But for example, naturopathic physicians do a unique procedure utilizing a basically a finger cot that's slid up into the nose and blown up very quickly and then released for people that have certain sinus problems, we call this the endonasal technique. To my knowledge, while this is universally trained in all naturopathic medical schools as an intervention, some people become quite specialized in it and do a lot of it. To my knowledge, for the management of sinus and other oralpherengeal(?) problems that may benefit by getting the bones back in place, they have deviated septum, very simple, very quick, but not separately billed. There's no separate code for that.
It would be useful from a utilization and from an outcome perspective whether people with sinusitis did better who did the endonasal technique versus some sort of surgical procedures, this is cutting or ablation or what have you, rhinoplasty(?), that this could be a very useful thing. But if that's going to be separated out then one also has to deal with a larger issue, it seems to me, revolving around many incidental procedures that take place as part of a basic practitioner/patient interaction that I think many of us consider part of an evaluation and management interaction.
So it seems like at some point, and I think that that's what Alan you tried to address to some significant extent in the testimony from IHPC, that it gets, to me it gets very complex to understand exactly, who was it, I'm sorry it was, I think it was the testimony for the Nursing Association that said the who, what, why, where, when, how, that sort of like why are we doing this, is sort of the question on the table. And it seems that ultimately the reason is that there's an awful lot of valuable services that aren't being useful, potentially efficacious, we don't know, all the studies haven't been done, all that stuff. But potentially efficacious, cost effective interventions that are totally off the radar under current CPT, so that might be one of the why's that we do it.
Then when you get to this degree of, I think the term that I heard Michael Bebee using and also this morning, granularity, when you get down to too fine a level of granularity, then it winds up becoming not only a, reaches a certain level of absurdity, but it also may be discriminatory because that granularity may be required of one practitioner group and not another. And it may be also at a significant burden in terms of time to capture all that information and to actually put it down in a chart, document it and then translate that into whatever the emerging new form that takes the place of the 1500 is going be.
DR. ZUBELDIA: Let me follow up on that for a second. Are those procedures different, I'm not talking about that nasal procedure, but are those procedures different according to who renders the procedure? Is a consultation different according to who renders the procedure and should they be coded different?
DR. KALE: This is Dr. Kale again, I'd like to respond to that because I think it is depending on which practitioner does it. For instance, homeopathic prescription is not something that is isolated to a specific title. A lot of people do homeopathic prescription, some people will do that based on the presenting symptoms in the acute case and just give people a remedy to deal with acute symptoms, other people want to do a constitutionally based homeopathic prescription. The difference is one may take an hour and a half to two hours worth of interview to accomplish whereas the other one kind of comes out in the course of your history, physical and the usual things you would do in an office visit.
So for instance, in treating a cold, I might give them an herbal supplement and a homeopathic to treat the acute onset of the cold, which I would just put in the context of my office visit. However, if I wanted to do a constitutional case to really address this person's core problems with a homeopathic modality, now you're talking about an hour, hour and a half depending on who's doing it to extract the information necessary to make that prescription. That's a coding dilemma that happens because many people are going to use homeopathy, you can't have a homeopathic code, you're going to have to have something that distinguishes a homeopathic interview for constitutional basis as opposed to somebody just giving a remedy for acute care which may take minutes versus an hour.
DR. DUMOFF: This is Alan Dumoff. Another quick example, there's a code for neuromuscular reeducation in the CPT which for a physical therapist means one thing, but if you're a massage therapist trained in a thing called St. John's Neuromuscular Therapy, your work also faces the definition of muscular reeducation but it's a very different technique, it's not properly captured as to who's doing what when they use the same code. For example, not only might the time of service be different, but the length of service that it takes over a period of time to properly put that into effect might be different. So those things won't be captured by using the one code.
DR. ZUBELDIA: Let me ask, knowing that a specific procedure is different based on the specialty of the provider, and that's pretty constant all throughout, can different consultations be crossed, or different procedures be crossed, and have that homeopathic prescription be done by an M.D.? And will it be any different in terms of the amount of work or effort of the procedure itself than if it's done by a naturopath?
DR. KAIL: I think only in the context of what I was saying, some people doing just a key prescription takes a few minutes, others when you do a constitutionally based interview it takes a long time, I don't care who does it. So a M.D. may do a constitutional versus an acute remember, a D.O., anybody with any title can prescribe both ways, but what I'm saying is you're going to need to have at least two codes to discriminate between those.
DR. BICKFORD: This is Carol Bickford from the American Nurses Association. I wanted to make two points, one of which is our increasing reliance on information systems allow us to have more detail to be able to track our professional performance, for peer review or reflection on practice, what have I done, do I have these procedures in place as I continue my certification, my credentialing process, where I've identified my gaps, so that's one utilization of the information system to help us retrieve the more detailed insight into our practice. But secondly, we've been dealing in an environment where the thought has been there's only one problem related to a person presenting for care, but the reality is as we're looking at our increasing aging population with co-morbidity's, we are dealing with the whole person with multiple components of that that cannot be separated into a heart, there are other components. So the complexity is necessary for us to reflect that we are dealing with multiple issues and our 15 minute visit, which is really only five minutes where you walk in and say here's a prescription you're out, doesn't hold water because we know have significant complexity.
And those clinicians who are engaged in some of that whole system approach, whole care, how's your family situation coping with what's going on, those sorts of dialogues have to be appreciated from the standpoint of utilization of my time and my expertise, but also in my record keeping so that the clinician who follows me or is receiving this consultation understands what assessments have been made, where I am with the diagnosis, what problems we're dealing with, what the care plan encompasses.
DR. FREIBERG: Richard Freiberg. The coding reality today for the some 15,000 plus licensed acupuncturists in this country, regardless of what they have been coding, under the CPT and in compliance with HIPAA, there are only two codes, 97780 and 99781, one is acupuncture the other is electro-acupuncture, and they cannot be used together. Therefore the acupuncturist formally only have one code for everything they do.
DR. MILLIMAN: This is Bruce Milliman again. It seems to me that this is really where we have the most mileage for discussion, I personally am not clear, except as it may be defined in regulation or rule for a particular license, which could be a significant problem. But it seems to me that whether a person is licensed or doing a modality therapy like homeopathy or licenses in acupuncturist or whatever, that the basic components of the patient/practitioner interaction take place, there has to be information gathering, there has to be the history, some sort of iteration in the systems that I am familiar with, iervetic medicine, oriental medicine, and naturopathic medicine as well as conventional medicine all have an iteration of taking in certain important basic information that might be called history of presenting illness. And they all, without exception, have some form of physical exam component and so it seems that we're still back to the question of why, I'm not totally, I'm pretty conversed in the HIPAA compliant process and I think I understand that it's a good thing.
It seems pretty overwhelming and I'm not really sure that it wants to become even more overwhelming than it already is by putting in other layer sort of bureaucratization upon the provider rather than looking at it and seeing if it couldn't be, I'm not sure that what we're talking about isn't, couldn't possibly lead to making it even more complex than it already looks like it is and is going to become. Does that make sense? So all of this stuff could be basically considered under a more liberal evaluation and management set of descriptors, which I understand is already taking place, including your concerns.
DR. FREIBERG: Under ABC code yes.
DR. MILLIMAN: No, under CPT, I'm saying --
DR. FREIBERG: That's left to be seen.
DR. MILLIMAN: That's my point, I don't know, I'm saying it could potentially, under ABC yes, I don't mean no, not under ABC, but I mean yes, it could be done there, yes it could be done in the current procedural terminology in the evaluation and management component, not the procedural granularity necessity.
DR. COHN: Could I ask sort of a follow-up? I'm sort of resonating with what you're saying and I guess the issue that I'm sort of struggling with and maybe you can provide some guidance, and maybe Richard can too on this one. We're really talking about levels of granularity, and how specific are we going to get in terms of coding. And on the one hand obviously it's very convenient to code in E & M single code for a visit. On the other hand you lose information. Now in the world of probably payment, there is something to be said for convenience. On the other hand for outcome studies, you obviously do not want to obscure everything that's going on. Now the question of course is can one code set do both without driving everybody nuts? And I don't know the answer to that one, but I guess I'm sort of wondering, I mean it seems to me that there's, that clearly there needs to be outcome studies done to validate a lot of stuff. And then once it's validated there needs to be some ways to conveniently represent it as a service that's provided, and I know Richard, do you have a view on this one? Is there a way to do both or is it really that we're talking about two separate processes and two separate issues here, one which is much more granular than the other? And Bruce you may have some comments, too, on that.
DR. NAHIN: I'm not sure if I can comment on whether there needs to be two systems of coding but from a research perspective, you certainly want to be granular, I mean you want to fully describe the treatment that's being given. If it's acupuncture with cupping or not cupping it's important to know, if it's moxibustin it's important to know. You even want to get more detailed than that, you want to know the length of treatment, the frequency of treatment, how many needles they're using, the place of the needles, it goes on and on and on in a given modality, if you really want to understand from a research perspective, be able to relate a treatment to a specific clinical outcome. Now whether you can do that in an insurance coding system, I don't know.
DR. COHN: Richard, one other question then, which is obviously the outcomes is the other piece here, and how are you going to be coding, how have you been coding the outcomes? Because obviously we're not talking about, I mean diagnosis is not outcomes, procedures are not outcomes, interventions are not outcomes.
DR. NAHIN: Because of the research that we fund, the primary audience is really the conventional medical community, not the alternative medicine community. So it has to have outcome measures that are accepted by the conventional medicine community. So if we're doing a trial looking at acupuncture for depression, which we actually are funding two such trials, the primary outcome in those trials is actually depression as measured with the DMS-4. Now as it happened, both of those trials are also looking at the traditional oriental medicine diagnosis that might underlie some symptoms associated with depression. As the acupuncturists can tell you here, depression isn't really a term in oriental medicine, there's other ways that similar symptoms, the way that people appear might be diagnosed and treated. So in these trials they're looking at acupuncture of depression, they are both diagnosing and documenting outcome using conventional medical terminology and oriental medical terminology.
DR. KAIL: Another issue I'd like to bring forward is the whole issue of pharmacy. Conventional medicine works out of pharmacies or hospitals and you can capture what kind of things are being used very easily from that endpoint because they've got their own coding system and whatever. Whereas alternative medicine, at least the stuff we give to the patient, is often dispensed by the physician, there is no pharmacy. So there's a whole bunch of issues around control of quality and a whole bunch of other things there, but if you're really going to capture what was being given to the patient to make them better, then you're going to have to get pretty distinct about what is the pharmacy code that's being dispensed out of the office, is this a homeopathic remedy that's being given, is it an herbal remedy, is it a nutrient? Usually it's a combination of all of the above in some form or another or in some visit or another. So as far as outcomes and what's really being utilized other than procedural services, I think you're going to have a hard time in looking at specifics of what kind of agents that are being given to people to take home or use at home. It's not covered well by the codes that exist.
DR. BICKFORD: Carol Bickford, American Nurses Association. Our nurses are identifying that increasing numbers of patients or clients are coming to them requesting natural, not pills, I want natural stuff, so there's increasing call for utilization of non-conventional therapies. I don't want to take those pills.
DR. MILLIMAN: This is Bruce Milliman again. I think it's the same issue for me is that I'm still trying to wrap my own mind around what it is that we're, why we're doing what we're doing, and my understanding, and correct me if I'm wrong, but my understanding that the purpose of a provider, from the perspective of the discussion I thought we were having, is to characterize a service, quite separate from the diagnosis, that's another discussion, to characterize a service sufficiently for the purpose of reimbursement. And if those investigations and studies are to go forward, and they certainly are in many settings, there are special arrangements made and special circumstances are devolved to make it possible to track the data that we're talking about, for example if we're talking about a particular agent, this isn't new stuff. What about comparing metholtestosterone(?) to testosterone? Or some other two agents that are approximately comparable? It doesn't show up in current coding and I don't think anything that we make a decision about with respect to the discussion before us would alter that state of affairs. So I'm, it seems to me that why we're what we're doing has to do with characterizing a service sufficiently that a third party payer can make a decision regarding payment. And the necessity and desirability, which unquestionable, to be able to track various kinds of interventions, performed under various obviously kinds of licensed and also non-licensed and even self prescribed arenas is a separate thing, and I don't see that really relates to this HIPAA compliance issue.
DR. ZUBELDIA: Ok, we have a comment from the back of the room. Michael, you go first.
DR. FITZMAURICE: Yes, I have a question for Dr. Paul Faust. You mentioned in your testimony about your inability to be licensed as a physician in Maryland, it means that you can't, I'm wondering, does it mean that you can't monitor the effects of an herb or other substance that you give to a patient in the patient's bloodstream for say toxicity, and for this I think I inferred that you must refer to a licensed physician in Maryland, so that current databases that have codes in them and can be analyzed would contain the physicians lab test and maybe his or her interpretation, but not your recommendation or dispensing of the substance or the herb.
DR. FAUST: That's correct. A lot of times it's not all that difficult to have my lab work incorporated through primary care providers, it's a matter of I make the recommendations, please consult with your primary care provider and request the following tests for these reasons. Most of the time those are done. But the licensed provider often has no idea what bearing it has to my treatments or is able to track outcomes.
DR. FITZMAURICE: A second question for Alan Dumoff. You mentioned in your testimony regulation of ABC codes to category three status for tracking only is not an acceptable solution. So my question is does the CPT editorial board do this, is it to enable research to show the evidence of effects on patient outcomes? And does the CPT editorial board determine the level of evidence required to assign a CPT code and is that same procedure then adopted by the alternative medicine codes?
MR. DUMOFF: My understanding with CPT is that for them to bring a code into acceptance it requires submission of five peer reviewed studies that are supported by the panel as valid studies, so that there is a minimal level of determination of medical acceptability or necessity for that. Whereas with ABC codes, because their interest is in a broader tracking interest, they would not have that standard. So I think that when, in terms of the category three analysis, that right now what AMA is doing is that if they don't have the five studies, if they think it's important to track it but that we don't have sufficient evidence yet, then they make it a category three which means that it's for tracking only and would not be reimbursed. So my concern is just that in effect becomes a ghetto in terms of reimbursement and that while we want to be tracking these things, we want to moving forward for reimbursement policy those things that do have evidence.
DR. FITZMAURICE: But part of this is not just the CPT process, it's also insurance companies saying we'll only pay for CPT codes, we won't pay for the category three or the level three codes. Is that it?
MR. DUMOFF: I think that's accurate although I believe the stated definition of the category three codes by the CPT process is that they're not codes they intend to have reimbursed.
DR. FITZMAURICE: Thank you.
DR. COHN: Can I clarify that? I think that actually it's, that it's not paid if it doesn't get RVRVS(?) units I think, and I think that it's an individual payer provider but clearly it does not have RVU's associated with it, which you're very correct about.
DR. FITZMAURICE: Thanks for the clarification.
DR. KAIL: This is Dr. Kail again. Utilization has something to do with this, whether codes get put in or taken out have to do on how many of the physicians are using the codes, and are these the physicians that we recognize as experts in the field to use the codes. As an example, there's a little test that I do to screen for protein malabsorption called an indiken(?) test, which is well described in all the lab books, and used to have a CPT code. It's a little screening test you can do in the urine, urinary indiken. Used to have a CPT code but they dropped the code because gastroenterologists weren't using it. Well there's a lot more expensive tests you can do to look at protein malabsorption, but a simple ten dollar urine indiken test is a great screening test that does it real safely and effectively and cheaply, that's no longer used so it got deleted. So I was using the code before and now I don't even ask for reimbursement for it because there's no way to get the reimbursement, I just do it for gratis for ten bucks. But the point is is that utilization is a real important part of this, it's going to shape the codes' use, it's going to shape whether it gets added, deleted or further modified by the utilization, and the utilization is the part that we're not being able to capture well because it's proprietary information. So I think until we can get better ideas about who's utilizing what services, we're going to have a hard time designing the codes that are let's just say the be the most efficient at describing the practice in the greater amounts of patients.
DR. ZUBELDIA: Thank you. We have a comment from the back of the room and then we're going to switch into the second panel. Would you introduce yourself please?
DR. SABA: Dr. Virginia Saba, developer of the home health care classification system. I just want the Committee to be aware that care is being moved from the hospital to the community and that home health is a very large segment of where services are being provided, and we're talking about hospital care and office care primarily in this meeting, and the field of home health care is being overlooked completely. There are a large number of nursing providers as well as many other health professionals providing services in that arena, and it really should be addressed.
DR. ZUBELDIA: What coding system do you use?
DR. SABA: I use the home health care classification system, which was developed through a multi, a contract funded by the Health Care Financing Administration. It hasn't been, it hasn't been approved as one of the HIPAA code sets.
MR. BLAIR: Does it accommodate alternative procedures?
DR. SABA: No, it accommodates primarily patient care procedures provided by the nursing and other Medicare provided providers in the home health arena, and there are six other home health care providers. It does cover that so that would get at the home health aid, the physical therapist, the speech therapist, the occupational therapist, and the social worker. It has been integrated into the ABC codes this year, but it is still a very large area that needs to be addressed, tracked, care needs to be identified, and outcomes measured.
DR. BICKFORD: HHC is also registered with HL7, correct?
DR. SABA: Yes, it's registered with HL7, it's been approved by ANSI HIS, it's in the UMLS, it's in SNOMED.
DR. ZUBELDIA: Thank you. Thanks to the entire panel, this has been extremely informative, probably the best panel we've had in complementary and alternative medicine. I want to thank you and we are going to move onto the payer panel, the health plan, sorry, the health plan panel, and if you will introduce yourselves first and then Joel Stevans starts first.
MR. STEVANS: My name's Joel Stevans, I'm the director of product development at Landmark Healthcare.
MR. HEGETSCHWEILER: I'm Kurt Hegetschweiler, vice president of professional and governmental affairs for American Specialty Health.
MR. STEVANS: Again, this is Joel Stevans, director of product development at Landmark Healthcare. I'd like to thank the chairman and the vice chairman and the Subcommittee for the opportunity to testify today on this important subject. What I'd like to do is give the Committee a brief overview of Landmark, talk some about our insured alternative medicine products, talk about our coding preferences, and the mechanisms of reimbursement that we do use. And then finally end with two examples that I think will illustrate some of the challenges that we have with the current code sets.
Landmark Healthcare was founded in 1985 in Sacramento --
DR. ZUBELDIA: Excuse me, let me interrupt you for a second. The members of the other panel, if you want to stay for this afternoon's discussion, you're welcome to stay. Sorry.
MR. STEVANS: That's ok. Landmark Healthcare was founded in Sacramento, California in 1985, we're incorporated as a chiropractic IPA. In 1995, '96, our networks expanded out of California into the Southwest and the Northeast. In 1997 we created a Knox-Keene License Specialty Health Plan for chiropractic benefits. A year later our Specialty Health Plan License was expanded to incorporate coverage for acupuncture and herbal therapies. Also that year we added an insured massage therapy benefit. In '99 we added in addition to the other benefits a nutritional counseling benefit. And as of today we have 2.2 million insured lives, and another nine million members under discount or infinity programs, and we offer insured products in 15 states.
The insured CAM products and services that I'd like to discuss today are chiropractic, acupuncture, massage therapy, and a new prevention and wellness option that we developed in 2002. First however, I'd like to kind of set the framework for the discussion with a discussion of our coding preferences. Wherever possible we choose to use the standardized HIPAA adopted data code sets, and the ones that we use most commonly are the ICD-9, CPT codes, and the HCPCS codes. When those code sets prove to be inadequate, we have some fallback positions that we will go to. First we'll look to some other regulatory body or agency that may have a standardized code set for the products and services that we're looking to offer. For example, when we began to offer an acupuncture benefit, the acupuncture, CPT codes for acupuncture were nonexistent. So what we looked to was the California's Workmen's' Compensation system that already had codes, five digit numeric codes developed to identify the acupuncture services that we were going to provide as a covered benefit. If those code sets aren't available, what we will then do is look to the CPT code book for unlisted or unspecified modality procedures. We choose to do this kind of not as a last resort, but we don't like to do it because it makes tracking very difficult, it increases our administrative burden, we have to manually review all those claims that come in with an unlisted code. And then finally, we will look towards a proprietary code set if either of those two alternative options don't prove beneficial.
Our chiropractic benefit, the conditions we cover are select neuromuscularskeletal and neuromuscular conditions, and those are all identified by standard ICD-9 codes. The reimbursable services include examinations, manipulation, physical medicine modalities and procedures, radiology services, preventive and wellness visits, and DME. Now the way we identify those codes are through either CPT or HCPCS codes. I have attached as an appendices in the back a list of the CPT codes that we typically reimburse for, along with the description. So that is available to the Committee for chiropractic, acupuncture, and for the massage therapy.
Our acupuncture benefit, we cover select neuromuscularskeletal and other NIH validated conditions that are identified, again, by standard ICD-9 codes. So some of the NIH validated conditions that we do cover are acupuncture for nausea due to chemotherapy or pregnancy, allergies, asthma, allergic rhionitis(?), those types of conditions. Our reimbursable services include, and this is an inclusive list, evaluation, acupuncture, electro-acupuncture, acupressure, cupping, moxibustion, herbal remedies, and again, preventive and wellness visits. I would like to just point out a couple issues here.
As far as the conditions that are covered, we do identify them for reimbursement purposes with standard ICD-9 codes. However, our organization relies on prospective and concurrent review for the authorization process. So on the authorization forms, we ask our acupuncturists to provide us with the traditional oriental medicine diagnoses, so the case manager can look at that diagnosis, use it in their evaluation of the case and the authorization. However, for the reimbursement, we will ask that a standardized code be used. Also with the herbal remedies, this is an area that was discussed earlier and this is our only true proprietary code set that we use. We have developed an internal code set that can identify an approved manufacturer and the herbal remedy that is being supplied to the patient.
I have intentionally kind of overlooked the preventative and wellness visits, I would like to use that as an example later on, so I will discuss that in more detail in a few minutes.
Our therapeutic massage benefit, we cover acute musculoskeletal conditions upon medical referral. We do not ask our massage therapists on our Specialty Network to diagnosis the condition, what we ask is that they pass along with the claim the referral form from the physician that does have the ICD-9 coded, so we are able to track it that way. We do reimburse for both deep tissue therapeutic techniques and gentle therapeutic techniques, and what we've done is we've stratified those massage techniques with either a 97124 or a 97140.
Next let me discuss our mechanisms, our reimbursement mechanisms. As a health plan, one of our goals is to streamline administrative procedures as much as possible. All our claims are submitted via the HCVA 1500 form. Paper claims are converted to an electronic format. Our electronic claims are processed through a clearinghouse. The methodology we use for reimbursement is either a CPT line item reimbursement or a per visit reimbursement method. We apply an auto adjudication process, and we also track the utilization. One of the difficulties that we do run into as a health plan that reimburses for alternative medicine services is that using unlisted code sets, or unlisted codes, and proprietary code sets often increase our administrative burden because we are not able to auto adjudicate those, we have to manually review all those claims.
Now I'd like to present two cases. The first, one of the things that we do know is the demand for CAM services has always been driven by the consumer, and the desire for wellness and preventative care is a primary motivation for the use of CAM. Also, in the instance of chiropractors, an estimated 14 to 35 percent of all current visits are routine or wellness visits not related to a specific problem. So this, in response to this demand, we've created a product that will allow an individual access to discretionary visits for wellness or preventive treatment. That is in addition to the other benefit that offers coverage for acute medically necessary services. We needed a way to track the difference and decrement the appropriate benefit. And this is one of the hurdles we run into. So what is the best way to code this particular service? Is it through a diagnostic code? Is it through a procedure code? As we looked towards the CPT book, we looked at the E & M codes, specifically the ones that are available for preventative medicine services. And clearly to us, the services that are being provided in a preventative or wellness visit, at either an acupuncture or a chiropractic office, are more procedural based. There are counseling, there is counseling, there are recommendations for diet and exercise, but primarily the individual is coming in to receive either an acupuncture treatment or spinal manipulation on one of these visits. So we didn't feel that all the key components of that preventative medicine service had been met, so we chose not to use the E & M code. We also looked at the E & M code for counseling, and again, because this was a procedural based visit, we felt that that wasn't appropriate either.
From there we looked at the 9794 codes, which are the spinal manipulation codes. And those do offer pre manipulative assessment and post manipulative assessment, inclusive in the code. So we felt that that probably would be the most appropriate. However, that is the code we use to track our acute care medically necessary benefit. So that wasn't going to work for our purposes either, there was no way we could demarcate the difference between a wellness visit and the other benefit. So from there we looked for a modifier, and again, the CPT code book didn't offer a modifier that would allow us to accurately describe the services that were taking place on this visit.
So finally, coming full circle, we ended up using an ICD-9 code that best fit the intent of that wellness visit in a CAM practitioner's office. And so that's how we have chosen to identify the difference between these two services. Now does that accurately describe the services that are being rendered by these CAM practitioners? No. Will it allow tracking on a global basis for outcome studies? No. But for the purposes of reimbursement, has it allowed us to use a standardized code to identify the difference between the two benefits and reimbursement appropriately? Yes, and so we've chosen to do that.
The next case is something that also has been discussed today, and that is some of the gaps in the acupuncture codes. Currently we reimburse, as I said before, for cupping treatments and moxibustion treatments provided by acupuncturists. These codes are not listed in the CPT manual. So as I mentioned before, what we did we had adopted the California Workman's Compensation schedule, which had assigned the code 97802 for cupping provided by an acupuncturist, and 97803 for moxibustion provided by an acupuncturist. That system was fine, we were familiar with it, we started in California, our providers were familiar with it, we trained new providers as we added networks in other states. However, in 2001, the CPT code set was expanded to include these same codes, 97802 and 97803, and assigned them to medical nutrition therapy. So now we have a conflict there. The nature of our business, we work with large health plans across the country, we must report back. If they are receiving claims with these codes for medical nutrition therapy, and there's also claims going through the system and being reported by moxibustion and cupping, that created a big administrative headache. So what we chose to do then was back up a level to an unlisted code, the 97799, and we used that particular code, we asked our acupuncture panel to use that particular code to identify either cupping or moxibustion. But again, that increases our administrative work as these claims come in. What we have to do then is manually review each claim that has this unlisted code, and we're not able to auto adjudicate that.
So just in summary, what we choose to do is use standardized adopted code sets whenever applicable. The current code sets I think we all agree contain gaps relative to CAM services. A lack of standardized code sets creates an additional administrative burden for a health plan that also complicates utilization tracking and analysis, which has been discussed. And we see the need to expeditiously develop a process to develop codes specific to the CAM industry, but we would like to see those inclusive in the standardized adopted code sets we're already using.
Thank you very much.
MR. HEGETSCHWEILER: I'm Kurt Hegetschweiler, American Specialty Health. Thank you for allowing me to testify on this coding issues from a health plan perspective. Just by way of background, what our company does, American Specialty Health is a California company, San Diego based, it's a full service specialty benefits company for complementary health care. We call it complementary health care rather than CAM care. We administer benefits all direct access, virtually all direct access benefit plan programs for chiropractic, acupuncture, massage therapy, naturopathy, nutrition services in California and nationwide, for health plans, insurance carriers, employer groups and trust funds. Outside California we cover about five million people and in California we are a specialty health, licensed, Knox-Keene licensed, and there we cover another four million people.
We work almost exclusively with health plans, mostly very large health plans, Blue Cross, Cigna, Kaiser, HealthNet, PacifiCare and many others. American Specialty Health services include utilization management, quality management, member/provider services, claims processing and provider credentialing. And American Specialty Health and the Network, it's network affiliates are accredited by the American Accreditation HealthCare Commission, also know as URAC for the quality of its health care operations.
Affiliates of American Specialty Health currently hold individual contracts with over 20,000 providers, 13,000 chiropractors, 2,500 acupuncturists, and regarding previous discussion, in this case, they're all LAC's, licensed acupuncturists, maybe a handful of medical acupuncturists in there who specifically work as anesthesiologists and use acupuncture to alleviate nausea post surgical or post chemotherapy. But all the others are licensed acupuncturists. 4,300 massage therapists, 240 naturopathic physicians and 700 registered dietitians. Our providers are reimbursed on a fee for service basis based on contractually agreed upon fee schedules. Medically necessary services are rendered and our billed through HCVA 1500 forms using the AMA's CPT terminology to describe the services performed. Of course we use ICD-9 and HCPC codes for the other procedures and diagnosis.
All services are coded using CPT, the most common CPT codes currently used by our providers of course are E & M codes and then specialty procedure codes which would be delineated under the medical section or medicine section in the AMA CPT manual such as chiropractic manipulative therapy or treatment, acupuncture codes, physical medicine and rehab codes, radiology codes, pathology and laboratory codes. Providers are required to use the CPT codes available that are most accurately and closely describing the services they provide. For example, our acupuncturists typically use an E & M codes and/or acupuncture codes to describe their services, while doctors of chiropractic are most likely to use E & M codes, CMT codes, physical medicine and rehab codes, radiology codes, and where allowed and by scope of practice, lab and pathology codes.
American Specialty Health requires our CAM providers to use the AMA CPT coding system to describe their services because in our opinion it describes the services provided with uniformity and allows the use of a common language when working with our numerous health plans. We are a delegated entity so it is crucial that the data sets are identical with the large health plan data sets and their IT systems.
ASH has 15 years work of experience in use of CPT codes and we did coding, of course, long before some of the specialty codes were available for special procedures like CMT and the acupuncture codes. At that time, all that was used were basically E & M codes which would today be E & M codes and a few other codes that are nonexistent anymore, so today these are all specialty codes which we welcome for being available as do the professions that are actually using them.
For instance, just to give you a feeling for numbers, in a 12 month period, I gave you a couple numbers here from 07-01-01 to 06-30-02, our CAM providers were reimbursed for 2.86 million CPT code services representing a total of approximately 1.2 million claims.
CAM needs a coding system that is understood by health plan clients and all providers, not just complementary health care providers, I mean regardless of specialty. CPT codes meet this requirement because of their accuracy and longstanding use in the provider and health plan communities. Using CPT allows the rapid processing of large volumes of codes, using a common language understood by all the parties involved in the health care delivery system. In our world, we have very few complaints from our very large number of providers. They appear to be satisfied and certainly do not hear any dissatisfaction. I would like to add a sidebar that the CAM community, the providers are actually quite satisfied and quite happy to be part of the CPT system itself, rather than being, they worked very hard to get those codes and having other codes proposed, there is a worry in the CAM community that that will cause isolation rather than integration, and CPT, the CPT coding system has provided some integration for the CAM providers thanks to the same coding system. The vast majority of them feel that they are able to appropriately code the services provided, and they are also, remember many of them also bill secondary payers at the same time and the billing and claims have to be the same, the same codes when going to secondary payers and they can do this without difficulty.
As stated earlier, American Specialty Health as allianced with many health plans, probably about 60 or 70. Most of these health plans, among other delegated functions, delegate clinical management and claims administration to American Specialty Health. The data interoperability, data uniformity, and data integrity between payers is of paramount importance. And of course today with HIPAA and of course all our systems are HIPAA compliant, it's even more important. Incidentally, the report that this Committee sent to Sectary Donna Shalaha in July 2000, which was the report on uniform data standards for patient medical record information covers these very same attributes that I'm talking about here, data interoperability, data uniformity, and data integrity between payers. And it is a crucial link on the reimbursement side and the coding side itself of procedures.
There are currently CAM specific codes as we've talked about to describe CMT, acupuncture and massage therapy services. All our services are direct access, except for massage services, which are PCT referred.
It is our opinion that the coding needs of insurance are best met through existing AMA CPT coding systems. If deemed necessary, and I do believe that came out today, it is important to understand that there will be additional codes necessary, and there are currently efforts underway on the CPT side, on the AMA side, to add further codes. I happen to know they're working on adding acupuncture codes, and there are various committees working on adding additional codes. And we favor to have these codes added within that system.
It is important that CAM providers do have the ability to participate in the specific committees that AMA has, that they have lots CPT codes like Health Care Professional Advisory Committee, HCVAC(?), also the CAM Advisory Committee that they currently have, a new committee and as mentioned earlier, E & M Workgroups, be represented, representation of CAM provider is somewhat marginal on this committee and should be improved. But that is really an effort that should be done by the associations of these various specialties and they need to force those increased membership.
Adding more codes for procedures used by CAM practitioners to establish scientific route, which is something we favor, we appreciate the scientific rigor and the route that CPT historically has taken in order to add codes. I think just adding codes to describe various currently uncodable procedures is one thing, but it is important not just to add codes, it's important to add codes with some scientific background and viability as Alan Dumoff was rightly saying earlier. Just adding because you want to add it so you can cover certain procedures, I don't think in our health plan world is enough. We need to be able to justify the coverage, scientifically measure it, and have some kind of scientific validity.
One other piece I would like to add that has to do with research and outcomes, some of you mentioned this earlier. It's important to understand that a lot of research needs to be done but a lot of it is being done on the health plan side, mostly as you can imagine has to do with cost outcomes and cost comparisons of course on the health plan side. But that's very important to the health care system, it might just be that alternative or complementary health care might be cheaper for certain diagnoses. Well, the way to compare that is to compare these large data sets that are available in the current health plan system, and we have done some of this research, some of which will be published actually later this year, where we're looking at is a member less expensive, less costly to a health plan if they have complementary health care coverage versus if they don't. Is that changing their behavior, do they save money through the system, and of course money to the consumer eventually in premiums? The only way you can do that if you have comparative systems, and currently we have CPT, an excellent data system, so we compare of course equal codes and equal procedures so we can compare costs. Is there a cost offset or is there a substitution effect and so forth? So very important thing as a sidebar.
So we favor the scientific route that CPT and AMA has always followed, and does a very good job at. And as necessary, there will be codes added, and they're working on that, and this will continue to assist everyone in the effort to bring data uniformity and consistency to the reimbursement of all health care services.
Thanks.
DR. ZUBELDIA: Thank you for bringing us a payer perspective, sorry, a health plan perspective on these codes. I have a question for Kurt. Obviously you're pretty happy with the CPT codes you are using. I'd like to know more about how are you asking the providers to code procedures on interventions for which there is not a CPT code. Are you using the same generic 99 codes? It's for you Kurt.
MR. HEGETSCHWEILER: The answer is yes. We use CPT codes. I can give you a little example of codes just so you get a feel for, there's a couple answers to this. One is the answer is yes, we use completely CPT, we've used E & M codes and we use the acupuncturist needling codes, and so forth.
DR. ZUBELDIA: And for the things for which there is not a specific CPT code you use a generic CPT code?
MR. HEGETSCHWEILER: We use E & M code, that's correct. There's case manager similar to what Joel said here, we have the case manager then determines, if the provider doesn't code it appropriately the case manager will code it appropriately to fit in our system. But I can tell you, our alternative care providers know pretty much what code to use so we have very little problems with that. They, yes, you're smiling because they want to get paid, but they do know what to use. And granted there are differences in what an examination constitutes and the complexities and so forth but to us an E & M code, the choices that E & M codes provide seem to be adequate, to fit in various procedures and processes.
DR. ZUBELDIA: So let me understand, because you both have hard numbers, millions of claims paid. What's the magnitude of this problem? How many miscellaneous codes do you get that require manual intervention before payment? Is it 0.001 percent, is it one percent, ten percent, 50 percent? What's the magnitude of the problem?
MR. STEVANS: This is Joel Stevans with Landmark. Actually our auto adjudication process is running about, 25 percent right now of our claims are auto adjudicated so there's manual review of the other 75 percent.
MR. HEGETSCHWEILER: Very different in our company, virtually all the procedures and services are automated, and most of it is billed electronically. So we have very little manual adjustment, in fact we do a miniscule amount of manual adjustments. The providers simply are taught what to bill by the instructions they get year annually, twice a year actually, and they do it.
DR. ZUBELDIA: Have you checked each other's instructions?
MR. HEGETSCHWEILER: Can I add one other thing if you don't mind? To your question about, the other thing that people do forget, and I can tell you from data that we have, providers use a very, even if they have many choices of coding, of codes, they use a very small amount of codes by their choice. We actually give them much more than they use. If you look at acupuncturists, even though they have an E & M code available and they know they can use it even for sort of a, it's like Konrad said for various things and Konrad knows how that goes very much in the health plan world, they actually don't bill or don't code E & M codes. They have a vast majority just codes, acupuncture codes, very few of the 92,000, for instance of the 92,000 codes that we paid in acupuncture alone in the particular year or 12 months I mentioned, only 12,000 were E & M codes but it wasn't really because it wasn't available. Many of these professions have a long ways to go to understand actually what is necessary to do everything. We actually are, I can tell you a few years ago it would have been 1,000 codes under E & M and the rest would have been just acupuncture codes. They're just now learning how to do examinations and they're, managed care sort of has to make them grow literally. So there's another aspect to that coding. Now the people that are, the professions that are much more advanced in that is the chiropractic profession, chiropractors know very much how to code. The E & M codes fit quite well with chiropractic work and their examinations and the reexaminations and the complexity, so they're pretty much sort of integrated into traditional medical coding system and have been for some time, and of course they have to care about chiropractic medical treatment codes which were maybe started three or four years ago now, and which was really the missing link to actually show the mode of treatments that they do 98 percent of the time. I hope that helps.
DR. COHN: Well first of all I really wanted to thank both of you for coming, recognizing that you're both like me from California, I almost feel like we should have had gone out to visit you for this hearing. I actually sort of, Joel I wanted to follow up with you about your discussion around diagnosis and I am presuming, you mentioned one problem area and I'm presuming you're talking about the use of V codes to sort of solve that problem, and that doesn't allow you to track what's going on?
MR. STEVANS: Yes, it allow us to track what's going on, but it doesn't, that V code doesn't accurately describe the service that's occurring. So from a tracking perspective, yes, that works.
DR. COHN: Because the service is different for an acute problem versus preventative --
MR. STEVANS: Exactly, exactly.
DR. COHN: The other question, I just wanted to follow-up because obviously Kurt says almost everything is auto adjudicated, you said 25 percent of the things are auto adjudicated. Now is that because the codes aren't helpful? Everybody's using unlisted codes in 75 percent of the cases? Or is it more because you're doing prospective payment and you're actually trying to look hard to make sure you are authorizing appropriately?
MR. STEVANS: It's a combination of both factors, yes. We want to stratify the services as much as possible so we can track the utilization. So sometimes that requires the use of unlisted codes so we can get more granular, so that's going to affect things, certainly. But then there's other factors involved in the lack of the auto adjudication process as well.
DR. COHN: Ok, thank you.
DR. FITZMAURICE: Since I have Joel's microphone, I'm going to have to direct my question towards Kurt. I found it interesting that the coding system, that is the push towards E & M codes drives improvement in the health care practices of the people who submit claims to you, but that's not my question, that's just an interesting thought that I had. What I want to ask is if to decide what to cover, and the AMA has to decide what to put codes on, how does the scientific rigor of your coverage decisions compare with the AMA's level of evidence rigor for adding codes for a particular CAM service? Are they about the same? Do you require greater scientific rigor to decide what you're going to cover than the AMA decides what it's going to assign codes to?
MR. HEGETSCHWEILER: It's about the same. We are this far from the few codes that the AMA has done and complementary coverage really, or three disciplines, massage, chiropractic and acupuncture, there was thanks to the NIH as Joel mentioned, thanks to the NIH consensus statements and panels, that helped with those codes and the chiropractic had some research, probably more than most complementary health care. We have actually, we have quite some pressures from the health plans to, if we market a product in complementary health care or a specialty treatment provided by a specialty, the scrutiny from the medical director side from the health plan is actually quite substantial. So I would probably say it might be more than what the AMA requires for the coding.
MR. STEVANS: And if I may just second that. Certainly the medical directors do look at these CAM services very, very closely. And so the procedures that we put in place internally to justify our coverage services are quite rigorous so we can prove to our clients that yes, this is safe, it is efficacious, and it is a benefit that should be offered.
MR. HEGETSCHWEILER: And we are using codes that they understand to code the procedures, very important.
DR. NACHIMSON: This is for Dr. Stevans. You mentioned that basically your process in determining how to code so far has been use the standardized code sets and if there is not an appropriate code in those, look for some other alternatives. Under HIPAA you won't really have the opportunity to look for other alternatives, you'll have to use the standardized code set. You also recommended an expeditious process to develop codes specific to the CAM industry. Have you attempted to date to participate in the coding process with the standard code sets instead of looking for alternatives?
MR. STEVANS: Yes we have, specifically around the acupuncture code sets. And that is something that we're aware of and that we're moving initiatives forward to address certainly.
DR. NACHIMSON: Do you feel that there is at least some sort of an expeditious process right now or do you have some concerns with the way the process is working?
MR. STEVANS: I do, I do have some concerns, and one of the things that was mentioned earlier was the cat three codes, and perhaps even for reimbursement, including those services as a cat three code initially to expedite the process a little bit I think would be beneficial.
DR. ZUBELDIA: I have a question. I was intrigued by your comment that you use the preauthorization process to collect the oriental medicine diagnosis. That's a very creative way of getting what you need before paying. How are you doing to deal with that under HIPAA? Because you will not be able to send those using the HIPAA transactions.
MR. STEVANS: Right now our authorization process is not electronic, it's all paper.
DR. ZUBELDIA: Under HIPAA, if the providers want to do prior authorizations electronically, you'll be required to use the HIPAA 278 transaction. That does not allow for such creativity in collecting the data that you need.
MR. STEVANS: Perhaps you could help me here, but the traditional oriental diagnosis that we do collect is a matter of the history and examination findings as well, so it's included in that. And then also we do have the ICD-9 codes that are coded for that purpose on the authorization form. So that's simply another clinical finding that's passed along to allow for the authorization process.
DR. ZUBELDIA: I gather that you have not looked at the prior authorization transaction under HIPAA to see if it meets your needs yet.
MR. STEVANS: We do have a task force that's looking into HIPAA compliance and moving forward, yes.
DR. ZUBELDIA: You mentioned that you use several levels of coding, CPT if there's one available and then you go to workers' compensation, and finally proprietary codes. Who creates those proprietary codes? Do you use your own?
MR. STEVANS: Yes.
DR. ZUBELDIA: Have you looked at using the ABC codes or using somebody else's codes?
MR. STEVANS: No, we have not.
MS. GIANNINI: This question is for both Joel and Kurt. When you're negotiating a managed care contract with the alternative care practitioners, are you using the same conversion factors for the coding as you use for M.D. services? Or how are you negotiating fees for services?
MR. HEGETSCHWEILER: I actually can't comment on that.
MR. STEVANS: That is outside my realm of expertise as well.
DR. ZUBELDIA: Well, if there are no further questions, I want to thank you again for your participation and invite you to stay for the afternoon discussion. We're going to have a break for one hour for lunch.
[Whereupon, at 1:05 p.m., the meeting was recessed, to reconvene at 2:15 p.m., the same afternoon, January 29, 2003.]
DR. ZUBELDIA: We are going to continue with representations talking about the alternative and complementary medicine coding systems. And this afternoon we have Laurie Feinberg from CMS and Laurie is going to give us a presentation on code overlap and where the codes are that are being proposed.
DR. FEINBERG: My name is Laurie Feinberg and I'm one of the medical officers in a payment group in the Centers for Medicare and Medicaid Services. But I just wanted to make it clear that I was really asked to do this not to give an official CMS opinion of the code set, but to only give you really a technical review. It turns out that I am a physician, I practice physical and rehabilitation, so I am moderately knowledgeable about modalities and things like that, as well as being relatively knowledgeable about code sets. And it seemed like I also don't sit that far from Karen's office, so that explains how I got to do this evaluation versus somebody else. What I'll try to do, when I saw that the real title of code set overlap, I certainly hope that you don't expect me to go through code by code, because I really don't do that. If the Committee wants something like that done for the record I'll be glad to do that, but I think in short order your eyes would be completely glazed over.
The other thing I'm going to make clear as we're talking today about coding, not really about payment or coverage policies, this is about coding. And so that's really what I'm going to lean it to. I would say that a lot of concerns that I heard voiced this morning really do with those other two issues and that's really separate from what I was asked to evaluate.
The third thing is I was really asked to look at the Alternative Link code set and provide an evaluation of that. So I'm really addressing the code set as a whole, not just alternative medicine, and I wanted to make that clear as well, and I'll go on to sort of run through what I think is an evaluation.
The complementary and alternative medicine and nursing coding system is a proprietary code set, and it was developed and copyrighted by Alternative Link, Inc. It comprises of five letter codes, which are designated to report the following types of health care services: acupuncture, iervedic medicine, body work, botanical medicine, chiropractic, clinical nutrition, conventional nursing, holistic medicine, holistic nursing, homeopathic medicine, indigenous medicine, massage therapy, mental health care, midwifery, naturopathic medicine, oriental medicine, osteopathic medicine, physical medicine and semantic reeducation. That's a pretty broad range of things. The version that I reviewed was copyrighted in 2001, and I just want to make that clear because if there was a newer version I just can't comment on it, so I'm sorry about that.
To assess the code set I really used four, I used a set of criteria that had been I believe kind of explained in previous version of the, what the NCVHS would like a code set to do. I'll go over those criteria first, and then I'll do sort of a quick analysis of each of my response to each criteria. The criteria are that there's a hierarchical structure, that the code set be expandable, that it is comprehensive, that it is non-overlapping, it is ease of use, it is setting and provider neutral, it is multi axial and it is limited to classification of procedures. So I'm using what I believe is the Committee's own set of criteria by which to look at the code set.
The hierarchical structure. The layout of this code set really appears to be hierarchical, there are categories within the subdivisions and subdivisions within the categories. The wording is different for each code. The subtle distinctions between the services may be difficult to discern by an observer of the service. And that really is a key phrase. I really think that in terms of codes that are used for reporting, a service should be something that when I watch you do the service I should be able to tell what you're doing. And I think that that's kind of an important point, although it sort of sounds obvious. The code distinction designations, which are five letters, create unique code identifiers. The substance of the codes will be described under the subsequent bullets. So yes, it appears to be hierarchical.
Expandability. There is flexibility to add procedures at the end of each section. Each small section has an unlisted code. In the area of herbal and other products, there is not really the ability to continue the alphabetical ordering, because new products will have to be added at the end of each alphabet, there's a section for each letter of the alphabet, but will not be in alphabetic order. I would add, though, that a lot of coders now use computerized systems to help them do their coding, so it's not clear that that perhaps is as important as it might be to a user of a book. For some of these products they have multiple names and I'm hoping that the people who do the coding would not find this confusing. In addition, there are multiple unlisted codes. There are 25 unlisted codes in section A, 21 in section B, and 26 in section H, just to name a few, and that's because of all the subsections. But it does give you at least if you're doing an unlisted code, I guess it does give you, at least tells you something about the service if not being more specific.
The comprehensiveness. There is an extensive listing of procedures and products. It is not possible to assess whether some are missing. Some procedures are listed in code set may be in fact too granular for payers generally. For example, there are 15 codes dealing with parenting as well as additional codes for child safety teaching. I would note that the HCPCS code set does have actually one code for child safety teaching.
The NCVHS said that a code set should not contain insignificant procedures, although a judgment of the meaning of this statement needs additional clarification. And some of the procedures provide can be performed very quickly and typically accompany other more substantial procedures. In some sense one of the providers this morning gave us the example of the situation where you have the very short term nasal procedure, but other procedures, for example, in E & M coding the giving of an oral medicine would be not reported separately, though the medicine itself would be. So the administration of something like that that is minor would really tend to be bundled in with whatever visit there was. Unless it's the only thing in which case we actually have developed some HCPCS codes for people who just come in for medication administration, which is actually common in out-patient hospital systems.
So just to give you a sense of what that means, many services definitions are a little difficult to understand without, and also without units describing the extent to the service, and that often comes into play. Some of these services it's better to time, some of the services sort of have a beginning to end and you just count it by the service, some of them you count by the day. And in some of these codes, those kinds of units are indicated, in other ones they are not. But using terms, I would have trouble I think if I was watching a service, deciding whether something was coping enhancement, hope instillment, or mood management. And what actually every payer is worried about is that it might be coded as all three, without clear limits and definitions of the limits of services, and so that's always, I mean to a payer, the way a code set should be is like a set of tiles that completely covers a floor of available services, but none that overlap. That's ideal for us because then you can go to the specific point on a grid in the floor, but you don't find yourself not anywhere else.
And finally a code set should be limited to the services delivered to patients or clients that are billed electronically. Also codes that describe staff training, and there were just a few that I noticed like fiscal management of, it sounded like it was involved in an institutional or staff training, really probably don't need codes for electronic transmission because I think that those things are included in the overhead of an organization, and I'm not sure that those codes really need codes at all, at least from a payer perspective they don't. It is nice if you're doing kind of bookkeeping and you want to know what your staff are doing, but in general, the payers aren't very interested in it. And so that's a difference sometimes between descriptions of services that you might use internally versus ones that you're transmitting to a payer.
And what I would say is that in many cases, I was looking at another one of these services in the book, and this is CBEAI, and CBEAN, both of those, one is called integrative neuromuscular technique and the other one is neuromuscular reeducation. And one of them, these are both in the massage reign, one is capacity neural responses with point pressure friction, position and movement, and the other one is increasing appropriate neural response capacity using point pressure friction, position and movement. And I honestly don't know exactly, I'm not a practitioner in these fields, but I would hope that someone watching them would actually be able to tell the difference. But again, I would like to pay for someone who does massage for a period of time, a session a day, but if I have them telling me all the different, I know a little bit about manual techniques and I've worked with people who knew a lot, and they often call upon various things to get the job done, and to have to code each of them is an issue. As again, my issue is I want to, I would like a code set that allows me to really pay fairly for the service being delivered, but only have it really described in unique ways. And so that was something that I think is at least on a few of the codes is really a concern. But there are other codes clearly like cupping where I think know what cupping is, and there is a code for cupping, I think there were one or two cupping codes that seemed completely clear about what their meaning were.
Non-overlapping. Many of the codes seem to describe overlapping procedures within the code set itself. For example, there is a code for abdominal exercise, and another code for postural exercise. But when I learned my stuff, the abdominal muscles are postural muscles, and how would I know if I'm doing what I'm doing, so that I would have trouble picking the right code if part of, strengthening the abdominal muscles was something I was doing for back pain, am I doing a postural exercise or an abdominal. Also in different sections there are codes for therapeutic exercise strengthening in the BCAAQ, and for therapeutic exercise individually, BCAAT. In addition, many of the codes overlap with codes in CPT and HCPCS level two, and I'll go over some examples, because I actually can do that in the area of the physical medicine codes where I know them the best, and maybe in a few other sets if you're interested.
In addition, some of the codes, and there's also in the F and G section, I was concerned, there's a very long standing and authoritative standard for coding homeopathic products, the Homeopathic Pharmacopoeia of the United States, and it's recognized by the FDA as the standard for these products. And I would want to make sure that, it turns out that they actually also have a code set based on their compendium, and so I think it is, that either making a decision or knowing what's overlapping, I really myself do not know enough about homeopathic formulations to do that, but I think that that's certainly a definitive reference that we shouldn't ignore.
Ease of use. Although the multiple sections contribute to the ease of use, some of the sections occasionally contain a code that don't seem to fit. For example, under test and measurement, I found a service vasineneumatic(?) device, BDAAE, which is a treatment for wound care. I'm not aware of it being used as a measurement. Now that's easily fixed potentially by moving it to a different section. In addition, some of the codes as I sort of described are so granular that it would be difficult for an observer to decide how to code them. For example, as I said there are over 50 massage codes. Many of the codes don't contain units, I think it would be easier for any code set to have, to be perhaps just a little bit more inclusive of a range of services and give you a defined session, the appointment that day, what you treated the patient that day.
Setting and provide neutrality. This is actually an area I think where, I think that they purposely didn't abide by this. I think one of the original goals of this code set was to provide information on the licensing status and the provider status of the person delivering the service. But in some sense that information is available elsewhere on the bill, either through the specific provider ID or there's also a taxonomy code that's quite extensive and allows you to identify the type of provider. So having that information also in the code is something that may lead to additional sort of codes where it would be simpler to have only the information about what is being done and have the practitioners information conveyed in a different place on the bill in the electronic transaction.
Multi axial. These codes are generally not multi axial, each code does not specify body systems affected, technology used, techniques approach, and although not all the axis in fairness apply to alternative medicine procedures, I will add, though, that neither CPT nor HCPCS is multi axial. I think it's quite hard to design a multi axial code set. So I would just say that the fact that they didn't meet that criteria is, they've got lots of company.
Limited to classification of procedures. And clearly, many of the codes contain diagnostic information, so that they're doing a procedure to accomplish a goal, and I think that that is something that the Committee needs to look about.
But the conclusion is is that Alternative Link's code set contains many overlapping attributes with other systems related to services and products, there's overlap also in the lab test areas and in some of the products. We need to examine closely the codes of the Homeopathic Pharmacopoeia of the United States. To some extent, though, the services that are integral, in other words, some of the times they've broken services up into lots of pieces that would be integral to other services and other codes sets, and I think we heard that from the payers who spoke earlier.
At the end, analysis does reveal certainly sets of services that currently are not easily coded in any of the code sets. However, I would say that there is not large blocks of codes that can just be lifted from this code set and put into another code set, such as CPT or HCPCS. The key question is whether health plans, and we heard this, have the need to receive this kind of detail in their electronic transaction for services and products described, and the pilot demonstration, which was approved earlier this month, will give us the tools to evaluate the code set and highlight the issues that need to be addressed in the evaluation. This evaluation of the pilot will begin in about two years after the code set has been used. So if you want I can give you specific examples, or have I said enough to the group, and you're not interested, so I'm sort of responding to your pleasure.
MS. BEBEE: Could you repeat what you just said, the evaluation takes place in two years?
DR. FEINBERG: The pilot use of the code set, and this is something that I'm actually adding from the group and it was what Stanley read this morning, it will take two years, and after that time we'll be able to evaluate it and look at how well it performs and meets the needs of payers and providers.
DR. MILLIMAN: I was just wondering whether you look for overlaps in both, you talked a lot about procedural codes, but did you look for overlaps in evaluation and management as well, and if so what --
DR. FEINBERG: Did I equivalently evaluate CPT, is that what you're asking?
DR. MILLIMAN: No, I was wondering whether the, your sage opinion as to whether the evaluation and management descriptors of codes in the ABC code set are unique and distinct from the ones that are in CPT or whether they're talking about the same thing, I'm not very clear on that, I'm asking you as a coding person.
DR. FEINBERG: Well, I think the, under CPT, evaluation and management is extremely broad, they basically I think currently they have to have two or three elements, there's sort of, you see the patient, that's one of the key ones, you potentially exam them, although it may just be with your eyes. You develop a plan of action, so you evaluate and you manage. The codes, there's a rather wide range of codes, AAA to AZZ, and some are in pairs as we learned today, and will allow people to use CPT instead of them. These were broken down very finely into the type of practitioner who should have used each code range. And I'm wondering whether that's really needed.
There's also, there was a separate section for wellness of visits of different length, and there actually is a wellness code in HCPCS, it's S5190, wellness assessment performed by non-physicians. So there was one code in HCPCS where there was a range, a small range actually, but a range nevertheless, in HCPCS and there are, I don't know how well used they are by non-physician practitioners, but a range in CPT of the prevention codes, preventive care codes which are essentially wellness codes although you don't really, they're more phrased in the medical model and I can see potentially why those might be a little bit more problematic. For example, there are codes ADBAA to ADBAC, there were a bunch of telephone call codes. There were a bunch of codes for writing reports, all those things are already in CPT. Do you want me to go through this, is this instructive?
DR. MILLIMAN: I guess what I was trying to get to was if you're trying to assess the ABC code set it sounds like, and you've done an admirable job of breaking it down into very, that they should have these various characteristics, hierarchical, expandable, etc. Could you refine that to those criteria with respect to E & M, or what are equivalent to E & M codes in ABC code set, and procedural codes that are analogously in ABC, which already did? And it seems like there's a difference, from my perspective as a provider, there's a significant difference in the implications of the two different categories of codes as they relate to an alternative coding mechanism.
DR. FEINBERG: Well, I can also tell you that some payers as a business decision will not allow anyone but physicians to use those codes. I'm not disputing that there are payer decisions there. I'm still not understanding you I can tell.
DR. MILLIMAN: Maybe there really isn't a question here, maybe it's just I'm confused. I'm wondering whether your analysis process revealed to you any substantive difference overlap between the ABC equivalence to evaluation and management codes and the CPT evaluation and management codes. I hear the different distinctions that I think I understood as some of the more procedural things and some of the fine points, but not the basic visit codes, first visit, return visit, that kind of thing.
DR. FEINBERG: Certainly, the first visit, return visit, I actually thought that maybe a single code in each category that was say a 15 minute unit, or a ten minute unit that could be billed in multiple units might be an alternate way to go. Since the use of the E & M codes are really sort of different organizations decide who can use them, I mean I think there's lots of ways to go, I'm not really trying to criticize the code system. I understand why lots of non-physician practitioners want different codes and I think that's being considered, that wasn't really the level at which I was doing the analysis I think.
I can go to, for example, some of my specific, maybe it would be useful for me to go through the codes that I really couldn't, I made a list of codes that I really couldn't code and that might be in some areas sort of a good place to start rather than the overlap although I could do either way. For example, there was a criotherapy(?) chamber, which I believe there's no way to code in CPT or HCPCS. There was a hypothermia lowering something which, there's hypothermia during surgery, but I don't think you want to use that code. And I don't believe that's codable. I don't believe magnet therapy is codable. I don't believe steam cabinet therapy is codable with the current systems. I don't believe that a steam room is codable. I don't believe that a sauna, which has a code, is codable under HCPCS or CPT. I don't believe that steam inhalation is codable. I have sort of lists, just give you a sense of what kinds of services. There's something called constitutional hydrotherapy with sign. I really didn't think that that was something that was codable, as well as constitutional hydrotherapy, I thought that was, although I don't know exactly what it is it sounded different than a hubbard(?) tank, which is codable.
An Epsom salts bath or sitz bath, we actually in, there's actually codes for that equipment, but delivering the service is actually not a codable thing in either HCPCS or CPT, nor is cold laser treatment, mixed wavelength light, although that might be, there are light boxes now, treatment with light boxes, and the light box equipment is codable under HCPCS. There is infrared hemorrhoid cauterization, and I don't believe that's codable. There is infratonic QGM(?) and I'm, in the B series, these are all modalities and I don't believe that that's codable. Tuning fork therapy is not codable. There is an eye therapy, I think its eye exercises that it's not codable. BBAAF, hiatal hernia re-toning exercises are not codable. I would not encourage someone to use the regular 97110 therapeutic exercises because I think that's beyond what physical therapists, I just think that that probably wasn't, I don't know how it's done but I didn't think it was normal therapeutic exercise.
Low impacts aerobics is not codable nor is step aerobics, but there is a HCPCS code for an exercise class. BBAAY, exercise promotion, I don't think that's codable. BBABG, self massage training group in individuals, not codable. I believe that Tai Chi and Yoga as specific entities aren't codable, and Qi Qong individual and group aren't codable, Sut(?) Tai aren't codable. I mean I could go on like this, it's getting, I can imagine that you've had enough now. But if you want I can say that for example, I have lots of paper here but I don't want to bore you.
DR. KAIL: Konrad Kail again. I have a couple questions about this. First of all, in your opinion, I did not review both code sets. In your opinion, having done that, number one, almost all the codes that you have said were uncodable except for maybe one or two I would submit that probably less than one percent of the alternative medical population does. So by that standard I would suggest maybe there shouldn't be a difference. What I'm really concerned about is since most alternative practitioners are not in a reimbursement mechanism, maybe chiropractors aside from that and some acupuncturists, there is absolutely no knowledge out there about codes. What I'm really concerned about is this demonstration project, by the time it gets up to speed in two years, can we adequately educate the people that this is going to be done on, to be able to get good data out? Because I think they're going to have this amount of codes, the ABC codes seemed like they're very, very extensive, and they cover all kinds of alternatives, and I know that the learning curve for that's got to be pretty steep. People are not going to be efficient at using these codes right off the beginning, and by the time you recruit them and train them and then you run enough patients through with a dual coding system to do this, I don't know what the quality of the data is going to be at the end of that. I think the first part of the data collection is going to be a quagmire to tell you the truth, because there's too much minutia.
DR. FEINBERG: I actually am not involved with the demonstration at all, so I may ask somebody else to speak to that.
DR. FREIBERG: Richard Freiberg. I tend to disagree with the last comment. The 15,000 plus acupuncturists in this country would probably code most of those procedures, so that's more than one percent, maybe not one percent of the 700,000 M.D.'s, but certainly in the complementary and alternative medical field.
DR. ZUBELDIA: Laurie, can you talk to us a little bit about the other side, the overlap?
DR. FEINBERG: Sure. Probably the section that was the most consistent overlap was lab testing. I don't know if you want to, I can go through that. That was an area where a very large proportion of the codes overlapped, and I'm now looking at a section that starts with DEAAZ. Certainly if 3T3 is codable by CPT, I started writing down the code numbers and I, enzyme isolation and comprehensive melatonin profile, neither one of those are, but then glucose tolerance test is, glucose assay, liver function panel, GTT, I don't believe there's a caffeine clearance code, glycohemoglobin there is, TT3 is, total RIA, thyroid hormone binding ratio, proinsulin, insulin stimulating hormone, pure thyroxinasade(?), thyroid uptake, T3T4. There is not a code to the best of my knowledge, though I'm not as knowledgeable in the endocrine area of 24 hour thyroid profile, there is an LDL testing code, there is a glucose tolerance test with two hours and additional hours, there is a code for health, there is not codes for betacarotene that I found. There is a calcium code, a chloride code, an iron code, a magnesium code, phosphorous code, this whole page has codes, as does all but one or two codes on the next page. And a couple, and then one code, so there's about a total of seven or eight or nine codes in the whole labs that don't have codes. That's probably the most comprehensive, but there's in the section before that, I was just noting that there's a code for insertion of urinary catheter, we actually separate whether it's a straight catheter or an in dwelling catheter, but there are codes for both of those. I'll keep going on, I've got hours of this stuff. As I said, you couldn't possibly want --
DR. ZUBELDIA: Did you look at overlap with NDC codes?
DR. FEINBERG: I don't know the NDC codes, I'm sorry, those are for the drug products. I would have to ask someone else that question.
MR. BLAIR: Laurie, thank you, this is helping me a lot. And I sort of have a bunch of questions that I'm not even sure you're the right one to answer. You observed that from a billing standpoint, from a reimbursement standpoint there seem to be a lot more detail here than you would perceive necessary. Is someone here from Alternative Link and/or the other payers, well from Alternative Link, maybe you could indicate why you developed the codes in this fashion? Was it for other purposes than billing? And then maybe the other payers could wind up indicating how they were reacting to this, do they also feel the same way that Laurie does if this is beyond what they would be interested in.
MS. GIANNINI: Hi, Jeff, this is Melinna. We totally agree with Laurie by the way that the lab section is very much overlapping and we wouldn't even fight with that one, we would be happy to retire those codes. As far as the massage therapy codes, however, there are so many routes to additional training for massage therapy techniques that are different than 500 hour massage therapist license, that we felt the need for that specific detail so that we could assure training for the different techniques that people were going to be using. And in the case of Rolfing for instance, a Rolfer has an additional 2,500 hours of training above massage therapy 500 hours, so there's a very big difference in the Rolfing codes than there is in just strictly massage timeable event codes. I think that there's very good reasons in that section to keep the specific nature of the codes so that we can get down to the specific training of the techniques that are being used.
MR. BLAIR: Is the need so much for billing or for other reasons?
MS. GIANNINI: If I'm a PPO network developer and somebody wants to build a benefit for Rolfing, I'm required by law to submit information that says that the practitioner that's providing that service is qualified to do so. And so for those specific reasons I think that the detail is incredibly relevant to billing and to provider contracting.
MR. BLAIR: Do we have any of the other payers here, from Landmark?
MR. STEVANS: This is Joel Stevans from Landmark. You know your specific example, I think for reimbursement, that granularity would not be necessary. As far as techniques and provider contracting, we will do that on the front end during our credentialing process. We'll look at the techniques that are used, we'll look at the training of the individual, making sure that they have the appropriate certification, if that is an approved technique. But then on the other end, once the service is performed and just billing for it, we don't need to know necessarily the exact service, the exact type of massage that was rendered on that date of service.
MS. GIANNINI: Joel, one of the things that massage therapists are telling us is that they want a difference in payment between somebody who's only had 500 hours of education versus somebody who's had that plus another 2,500 hours of education. So they need and want that difference to cover their expense of training.
MR. STEVANS: Again, I think that that would be addressed in the provider contracting and the negotiation of fees on the front end as opposed to the reimbursement of the service.
MS. GIANNINI: I think that one of the reasons that we were very detailed about that was in thinking about how to streamline the provider contracting to be able to attach codes to each training standard as well as the billable events that would follow were really important to us. In other words, we wanted you to be able to have a list of codes for each practitioner in each state and the requirements for being able to supply that service.
MS. TRUDEL: I just have a follow-up question for Melinna. You say that a number of these practitioners have very different training requirements, and I'm a little naïve about this particular part of the code set, but it would seem to me that the different training requirements would result in services looking different. I mean if someone is taught to do a particular technique like Rolfing, doesn't it look different than a regular therapeutic massage? I mean, you're distinguishing in terms of the training of the person, but I think what the plan folks are saying is that what they want to distinguish is the service that's provided by the person, not so much how many hours of training it took to get them able to do that.
MS. GIANNINI: There's both. So there's a basic therapeutic massage code and then there's a massage code, there's two Rolfing codes, for the Rolfing services, yes.
MR. HEGETSCHWEILER: I would agree with what Karen just said. We are, and what Laurie said about time. We are interested in the overall category of massage therapists, and then how much time does it take, or how much time was spent for which we have codes in the CPT system. That's what we're interested in. I almost have to agree with Joel, the specific education, and Karen, the specific education that a massage therapist might have, or any other provider for massage therapy, this really is a decision that we make whether to credential a massage therapist or not that has, for example, 2,500 hours in Rolfing, do we want to do that or not, I don't know, but those are the kinds of decisions we make every day in credentialing criteria. And that's really where that part belongs, and when we do a 97140, whatever it might be a massage therapy in the CPT coding, that is generically for billing purposes. For billing purposes the way we would like to have it because if you look and what Laurie was saying, if you look at just the sheer amount of codes available to just one discipline, one single specialty or even a subspecialty thereof, it would be a major challenge to identify each procedure and actually understand each procedure for anyone that has not actually has done that, and we would be very challenged in trying to base reimbursement and coding reimbursement on those kind of codes.
MS. GIANNINI: I disagree with that totally, and the reasons is that I think that they're specialties in the medical arena that are paid according to training and setting and everything else, and that's why there's 8,000 CPT codes, there's over 8,000 CPT codes, and it's so that you can price a service and pay for a service based on training and malpractice insurance rates, and all of the things that go into developing the appropriate RVU for a procedure. So I disagree with you.
DR. ZUBELDIA: Melinna, the procedure code for an initial office visit is the same procedure code for initial office visit for a pediatrician or for a brain surgeon. What they do is very different, but the code for initial office visit is the same. I think that's what we're talking about here, and whether the Rolfing is done by somebody that has extensive training or an untrained person, the code is probably the same.
MS. GIANNINI: What this coding system attempted to do is provide information that was not generally available to the industry and --
DR. ZUBELDIA: But it is now, the HIPAA transactions have something that we all provider taxonomy codes that describe the provider services and their specialty and the type of training they have and so on. It's not in the coding system, it's somewhere else in the transaction.
MS. GIANNINI: When we developed this the provider taxonomy was not there and we could easily map what we have done in the provider modifier area to the provider taxonomy area and still maintain I think information for the industry that they don't have in other ways.
DR. HUFF: I'm going to change the subject a little, so if there are other questions on this that you want to handle first, that's ok.
MR. BLAIR: Actually this was one of the observations that you had at lunch, because I think that what this is getting down to is what is appropriate from a billing standpoint versus what is appropriate for a patient care or outcomes standpoint. And as you know, there's multiple aspects of HIPAA, one of them is the HIPAA financial administration transactions with all of the ICD and the CPT codes and possibly the alternative billing codes, which is being considered. So from that standpoint, I think the folks are looking at it from the standpoint of how does it fit for billing, but the other piece is with respect to the patient medical record information, and we're looking at that separately. And the criteria for that is separate, so I think that there tends to be a little bit of confusion and sometimes Melinna maybe you want to make a comment about that in terms of how you perceive where alternative billing codes fall, do they fall in both areas, do they fall predominantly for billing, how do you want to be perceived?
MS. MOLINA: We've switched speakers on you, it's Synthia Molina now, CEO of Alternative Link. These codes are a little hard to evaluate using strictly, this is just my opinion, using strictly the HIPAA transaction evaluation criteria, and it's for the reason, Jeff, that I think you're bringing up, which is that the codes were developed with three areas of functionality in mind. They were developed as research tools, they were developed as administrative and management tools, and they were developed as commerce tools. And so the level of precision and granularity supports all three of those.
Now in my mind there is no question there are going to be some areas of the codes where the insurance company is going to want to see maybe a fraction of the codes that describe acupuncture, or a fraction of the codes that describe chiropractic. But that in my view is the same prerogative that's been exercised in their evaluation and processing of CPT codes on HIPAA or CMS 1500 forms. So I think they're a couple different ways we could approach this, one of them is to look at the code set strictly as a commerce tool, and I think the code set has full benefits as a commerce tool. It covers areas of integrated health care that are not adequately addressed by the existing coding authorities. The code development process, the code maintenance process and the oversight process are more inclusive in the manner that you heard some of the practitioners speaking about this morning. So just on the basis of commerce alone, I think the code set has significant merit that's worth keeping in mind.
I think the other areas that Jeff is mentioning are sort of extra credit areas, in particular I think we're facing some significant challenges in this country with trying to identify health promoting and cost effective care. The need to shift reimbursement toward health promoting care is an issue that was publicized by Health and Human Services, it was an issue that Secretary Tommy Thompson mentioned, and actually took the insurance industry to task on for not having developed reimbursement mechanisms for wellness or in the approaches to care. And in support of the insurance industry, I think it's been really hard for them to establish transactions, commerce, contracts, in those areas. I think this code set is a way to address the priorities of Health and Human Services and getting a more health promoting approach to care, and meet the claims adjudication and contracting and benefit design and utilization management and clinical practice management and outcomes research and actuarial analysis needs of insurance companies, so it really does both.
There's no question in my mind having reviewed the code set myself and also having outsourced to an independent third party that there are overlaps between this code set and the existing code sets. In our outsourcing our expert found less than a ten percent overlap, and our organization has no interest in duplicating codes that are available in other areas. What we are interested in is providing to those individuals and those covered entities and their business associates in the industry the tools they need to support the health of the public, and to support official business processes, and for plans to free up resources that are currently going to inefficient health care and free those up for more reinvestment in the economy. So those are some of the considerations that I think are important.
This code set meets the guiding principles that are outlined for code sets in the Congressional and regulatory language. Yes there is overlap and we are prepared and actually desire to retire codes where there's overlap. We have an inclusive process, we are eager to cooperate with any code set authorities there are, and it's a book, this is a book now that's two years old as she mentioned. We have a much more sophisticated code set now and we think it has immediate value and we hope you'll consider that. I suppose that answers the question.
DR. HUFF: Kind of a new question. As noted earlier and also in your literature, at least three of the nursing code sets are included. The University of Iowa NIC codes, Karen Martin's Omaha Intervention Codes, and the Home Health Codes that Virginia Saba, and how were those included in this set? Did you make new codes for the exact things? And are the complete code systems for each of those included or is it subsets of those nursing terminologies that are included? How is that done?
MS. GIANNINI: This is Melinna again. When we put the, we've started off with the nursing intervention classification system when they asked us to incorporate it into this code set. The nursing intervention classification system is more designed to talk about what nurses do, less designed to talk about billable events. And so we collaborated with them to design what was a code set that talked about what nurses typically did to patients and how to do all aspects of that procedure, as kind of directions for a procedure. And then we honed it down to what is a billable event and what is not a billable event from that classification system.
The next system that we put into the code set was the home health classification system, and there was overlap that we tried to eliminate between the two code sets. When Virginia was still here she had a way of actually saying that there was four procedures in her set that could look like one procedure in a NIC code, and so we went back and forth discussing that for a long time until we came up with something that looked like billable events, that was kind of our criteria, is this a billable event? When we added the Omaha System which is public health care code set, there was overlap again between the other two code sets and we used Karen as our resource there to talk about any places that we felt like the overlap needed to be eliminated. So we worked extensively with the three code set developers to get their agreement that there was no overlap between the three. I don't know if that answers your question, but that's what we did.
DR. HUFF: Well, it's certainly good information, but specifically then, are there codes in the nursing intervention schemes that correspond one to one to your codes or are their codes more specific that you would say if these things happen then I would code this billing code which is actually an entirely different code than what exists in the nursing schemes?
MS. GIANNINI: I would think that there are very, very close relationships and that code sets were designed to do different jobs is how I would try to qualify that. The words themselves probably have one to one matches on definitions sometimes, but what they're used for are two different things. Did that answer your question?
DR. HUFF: Yes, and then one further clarification. In looking at the overlap that you had the independent expert do, the number that you quote I think is less than ten percent is accurate, or exact matches. But then when you look at the other categories of things where they said it didn't capture exactly the same intent, so it had a distinct meaning but was very close, that number became greater and greater and depending on how you interpreted, in that sense the overlap of those things that are sort of close to each other is actually worse in the situations where it's an exact overlap, because people have a choice between very similar things, which makes it more difficult to be reproducible and assigning those codes.
MS. GIANNINI: We considered retirement of codes if the words were exact matches and the meaning were exact matches we considered that it was an exact match. If the words were not exact matches but the meaning was an exact match we considered that an exact match. As soon as we left that category it was like we felt and so did the, well, the coding person had to feel that there was substantial difference in the action of the procedure and so therefore even though the words were similar it was a different action and therefore it was a different code. So it moved quickly off of the exact matches into the similar but not the same. By the time we got to level three, it was, the only match was on a non-listed procedure in the other code set, and number four was that there was no match anywhere. So we could give you the exact numbers of each category but I think that one of the other things that we can do is say where we agreed with that assessment. We will stick by there's less than a ten percent cross walk.
DR. HUFF: Well, I think that's true, but I think those other categories in fact, based on what your purpose of having the code is, whether those distinctions are important or not. So I'm not questioning that there were distinctions but I think it comes back to some of the earlier discussion, and for the purposes of this discussion and for billing, we could argue whether those other things in fact are overlaps from our perspective, not that there aren't differences in meaning --
MS. GIANNINI: We would love to have any of the Committee members that would like to dive down into the detail, we would like to send the database to you directly so you can look at it, if you'd like. We have an excel spreadsheet with everybody's comments on it and we'd be happy to send that to you.
MS. BEBEE: I just wanted to take Stan's first point a little bit further so that I could clarify and understand that point. From a practical standpoint with the nursing nomenclature as terminology and ABC, so when you work with the different developers from the nursing perspective, and you came to some conclusion. What I'm wondering is if at the end of the road, if vendors are sitting down and putting this into their systems, are their NIC, and whatever the Omaha system I guess is, and home health I guess, specifically those three, are the systems that will be developed putting in the ABC codes which would be different, the original NIC codes, the home health codes, and Omaha system codes?
MS. GIANNINI: I think in clinical terminologies if SNOMED was going to be the terminology that people were using that there'd be a lot over overlap and then Stan's point is very well taken that we'd have to probably eliminate a lot of the ABC codes or map them right directly to the SNOMED codes. We were talking about administration and billing services, we have not found those code sets in other products.
MS. BEBEE: Have you mapped the, I don't know that I'm getting the answer, that I understand. So if I looked at the NIC nursing code set, does it look different than what ABC has it in ABC?
MS. GIANNINI: Yes. And there's also an index in the back that maps each NIC code, HHS code, and Omaha code so that you can cross reference and index it that way.
DR. COHN: This is just some clarification that I need to make sure I was understanding. Synthia had commented when she was speaking just a couple minutes ago about the fact that the version of the code set that we're reviewing is as she described it was old, that you have a new and improved version? So I guess the question is is are we even talking about the right version of the code set either in our evaluation and what version is going to be used for the version? Or am I just confused?
MS. GIANNINI: We provided CMS with the current version in a database, not in a book. The book had not come out yet, so we gave them the database and we gave them the crosswalk work that had been done by our third party person, so they do have that database, they don't have a book.
MS. TRUDEL: I don't have a crosswalk. I have a summary of the crosswalk.
MS. MOLINA: My understanding is that you have the whole database, is that right? 2003, came from Alternative Links.
MS. TRUDEL: I may have that but I don't have the crosswalk.
MS. MOLINA: The crosswalk, the entire crosswalk, my understanding went to Jared Adair.
DR. COHN: Well, thank you for the clarification because we're sort of current.
MS. MOLINA: We actually went to great lengths in our view and kept a very good documentation trail of the number of times we tried to call the attention off of the 2001 version and emphasize that there was a 2003 version that needed to be reviewed.
DR. KAIL: I just was curious. How were the RVS schedules established?
MS. MOLINA: Relative values were outsourced to Relative Value Studies, Inc., which does a number of physician and dental relative value assessments as well.
DR. FEINBERG: Though I would add that really that would have been beyond our review completely, I was looking at the coding set. But I've spoken with Jared and I'm sure she would have given it to me if she knew she had it, I mean I don't think --
MS. MOLINA: So we'll just provide the documentation, it's the easiest way.
DR. ZUBELDIA: Synthia or Melinna, how are you going to handle all these discrepancies with a pilot? Are you going to clean out the pathology section of the codes, are you going to remove the duplicates, what are the plans?
MS. MOLINA: We have specific testing procedure identified in our application to the Secretary which I can read. Our approach is going to be a drill down approach, first we'll be working on the coding participants because we have a very short window of opportunity. We'll identify the participants and their tax identification numbers, we only have 60 days for that. So the initial outreach is going to be about attracting as many individuals as we can that represent the functionality that required to demonstrate cost/benefit of the code set.
From there we will be working with representative organizations in each of the health industry participant groups to have them identify for us what the hypotheses are and what the cost/benefit criteria are. They will work on secondary data collection first to ensure that when we develop primary data collection methodologies that they are appropriate. And so we're going to be using a drill down approach on a current industry participant basis. And that's what we're committed to in our application, is quarterly reports of findings to the Secretary and to major trade journals.
DR. ZUBELDIA: As far as the code set structure --
MS. GIANNINI: We forgot about the crosswalk. I think also in the application we had talked about our role is to retire codes as appropriate and working with the correct authorities to make sure that there are no duplications before we started off on this process. I think that there's going to be probably 150 but there's absolutely no question that we should retire them and then there's going to be another 150 to 200 codes that we're going to have discussions with everybody about and decide if they need to be reworded or the granularity needs to be increased or decreased in order to make them non-duplicative of other code sets. So we think that process is well organized, and if you have any suggestions about what you'd like to see we'd be really happy to hear your ideas.
DR. ZUBELDIA: And you're going to do that before the pilot study?
MS. GIANNINI: Yes, we had planned on doing that. As we said though, we're a little bit constrained with the 60 days. If we could extend that out a little bit more I think we could concurrently do some things such as that and work with the outreach.
MS. PICKETT: Just for clarification, because I don't think I'm quite understanding. Your intention is to retire the codes before you begin the pilot, so does that mean that you would be issuing yet another version of the code set?
MS. GIANNINI: Probably, instead of trying to commit to another version control because it's on an annual basis we would probably just list out the codes, take them out of the database, put them in an active, and then we deal off of electronic databases and then print out information that said please don't use these codes. As you know, building a version control for a year is a real bugger and so we try to just have one version a year and then our update, if we have to have any information go out to the industry in the middle of the year we think we can do that with file updates.
MS. BEBEE: Synthia you referred to the areas that ABC covered for functional use and you mentioned three areas, research, administration and management and commerce. So with this being HIPAA focus, are we narrowing this down to a third of ABC codes? Or I mean, a third, not necessarily a number but the third and so the function?
MS. MOLINA: No, what the Secretary asked us to do and you can see this in the copy of the letter that was handed out today is to separate the cost/benefit analysis that focuses on commerce application and electronic transactions from the cost/benefit analysis in other areas, and that's our intention.
DR. FEINBERG: I have actually one other comment is that there have been as a part of our conversions of Medicaid codes many overlap, especially mental health codes, and I would urge you to make sure that you have a vehicle to look at the 2002 HCPCS and even then look at our quarterly update, which is already posted on the website for April 1 in eliminating the duplicate codes.
MS. MOLINA: We have several government organizations that have already expressed interest in participating in the pilot program and so we will work very closely with government to make sure we're not overlapping there.
DR. FEINBERG: There's quite extensive overlap now in mental health which there may not have been a couple years ago.
DR. ZUBELDIA: What Laurie is talking about is coordinating with the new code sets that have appeared in HCPCS national codes as a result of merging the local codes into national codes, and you see some of those in the 2003 HCPCS, there are some that are coming during 2003 in the quarterly HCPCS updates.
MS. MOLINA: But what would be helpful to us is to identify the HCPCS folks as part of the study.
DR. FEINBERG: We actually posted on our website, we keep an update, for example, our April 1st codes are already posted, so you know about, the world knows about them almost as quickly, and our temporary codes, as we do.
MS. MOLINA: The Secretary has asked us to present, or has suggested that we present our study protocol to the Secretary before we implement, that is our intention. So we'll make sure that the code sets are cleaned up, if there are new code set in HCPCS, either from new applications or retirement of local codes, whatever the origin of new codes, we'll make sure we don't have overlap there as well.
DR. ZUBELDIA: Are you going to track your decision of the codes? One of the points that was discussed here today was that some of those codes may only be used for a small, very small fraction percentage of the routine operation. Are you going to track the decision of each specific code?
MS. MOLINA: We don't know the answer to that yet. What we do know is that we're going to drill down by health industry participant type and having them help us identify what the cost/benefit criteria would be for those segments, and if tracking to an individual code level becomes necessary to demonstrate cost/benefit for a segment then that's what we'll do.
DR. ZUBELDIA: It would be very useful I'm sure for you to know how many times each code is used during the pilot.
DR. FEINBERG: I have one other question. Are you going to separate the evaluation of the code set per se than to the RVU's who prepare only giving them?
MS. MOLINA: Well we're going to be look at cost/benefit sort of in looking at the codes themselves at the state legal guide that accompanies the codes, the provider modifiers that accompany the codes, the RVU values. And again, each group in the industry is going to be helping us to identify the criteria. Am I answering your question?
DR. FEINBERG: What I really wanted to know was whether you were going to have people use the codes separate from the RVU's you've developed because it really in some sense the, the RVU's in some sense are not a code set developer prerogative but the business decision of the organization who's paying the bills.
MS. MOLINA: Well we are committed to testing both the code set and the RVU's in practice, and the Secretary has simply asked that we separate in our cost/benefit analysis the costs and benefits associated with things other than the transaction itself in those.
DR. FEINBERG: Although I would say to you that even though you test the RVU's, you may convince the payers who you've gotten your demo to use them but they won't be, that's no, it's no guarantee that any payer will adopt them.
MS. MOLINA: I think I'm missing your point.
DR. FEINBERG: In some sense I think that a code set and payments for the codes really should be completely separate issues --
MS. MOLINA: I agree with that, and our challenge is that we're being asked to use them in electronic transactions, and without RVU's it's going to be very hard to have the codes have any value.
DR. FITZMAURICE: Laurie, could I try to interpret? Are you saying that you can test the code set and people may use it and it may be great, but they may not like the RVRVU's and the health plans will decide their own payment rates and may not use your RVRVU's, so you will say well, it's a failure, they didn't use our RVRVU's but they really like the code set, and you want to separate those two things out, is that it?
DR. FEINBERG: Yes, I think that's right. That in some sense I'm surprised you got organizations because what you're basically doing is you're setting a fee schedule for everybody who participates, I'm really, I guess they can use their own conversion factor.
MS. MOLINA: Yes, and they're not all our RVU's, they're developed by Relative Value Studies, Inc.
DR. FEINBERG: That's fine, thank you.
DR. ZUBELDIA: We'll take a last comment and then we'll break.
DR. BICKFORD: Carol Bickford from the American Nurses Association. I wanted to address how this is going to be funded. It's my understanding that this is an unfunded requirement, that individuals are paying out of pocket to make this all fly, that Alternative Link doesn't necessarily have any grant money to make this a demonstration project, so there may be constraints. I'm just identifying as possibly an issue and for the success of this project.
MS. TRUDEL: The regulations that, I believe it's 160.940, permit people to request a pilot, so this is not a requirement. No one has to request a pilot, no one has to participate in a pilot. And yes, it is unfunded in that we are not doing this as a demonstration project. There is nothing in the HIPAA statute or the regulation that would support the Department providing that kind of funding. I think the expectation is that if this is something that does have promise then people will want to participate.
MS. MOLINA: I just wanted to make one last clarification and that was in our testing, I think I mentioned this before and I'm just mentioning it again because I think it's important. We were granted a two year study, our commitment to the Secretary was to report results in three month increments, so we will be providing updates every three months on what's happening with the test, and we also committed that the test would end upon the occurrence of one of three things. First was proof of a widespread and favorable or unfavorable cost/benefit ratio ABC codes. The second was HHS naming or rejecting of ABC codes as a HIPAA standard. And the third was the end date of the test. So I heard before a comment that the test wouldn't be over for two years and I think that's not, that's not representative of the application or our understanding of what was approved. What we understand was approved was that we had two years to demonstrate the case, that we would be providing data every three months for evaluation and a possible determination at an early date.
MS. TRUDEL: The approval was for a two year period. There's a question as to the extent to which the interim reports would lend themselves towards a firm conclusion.
DR. ZUBELDIA: Let's take a break. We'll reconvene at 3:45 and we'll continue with the Subcommittee discussion.
[Brief break.]
DR. ZUBELDIA: Let's get started with the meeting again. We need to take a look at the next steps, there probably needs to be some, at least another hearing to discuss the issues of some of the specialties that we're not addressing here today. And to hear more about the pilot that Alternative Link is doing and I'd like to have like an outstanding thing to track that pilot. What we need to do now is talk about the issues that we have for discussion. Between now and the end of the year for 2003.
DR. COHN: I guess I was, what are we doing about this particular interest in now, before we transition to that?
DR. ZUBELDIA: Well I think we need to see where it will fit. I'd like to have this other hearing soon, but we have a plate that is overflowing, especially with the HIPAA implementation and PMRI and ICD-9 and it's just overflowing with issues. And we need to schedule perhaps another entire day, but one or two panels to see the rest of complementary and alternative medicine picture between now and the end of the year sometime. But I think that there's other things that have pretty high priority. So Simon, you want to take us through this list?
DR. COHN: Sure. I guess before I do that, and actually I wanted to thank for this set of hearings obviously Suzie Bebee who did a tremendous amount, Gladys Wheeler, Marietta Squire and obviously Laurie who I think has already left to go back to CMS to get some work done, obviously Richard Nahin who looks like also went off to get some work done.
Before we move on to the sort of list of issues is there anything we should just, any final thoughts from the Subcommittee about the hearings or do we just sort of, maybe we should just sort of reflect on them as we try to do planning for the remainder of the year. Thoughts, questions, comments?
MR. BLAIR: I just thought that today was very helpful to me to understand a great deal of things and I guess my understanding is that with the demonstration project that's about to proceed that that's going to address a lot of, that should surface a lot of issues with respect to implementability and so my thought was that maybe from a timing standpoint since we don't have to wait for two years, maybe something in the December timeframe might be a timely follow-up for feedback from Alternative Link on how the demonstration project is going.
DR. ZUBELDIA: Jeff, picking up on that point, there are some technical issues with the Alternative Link demonstration that will have to be addressed probably by the DSMO's on the technical side because they're going to be introducing new code set for which there is not a qualifier in the existing transactions. So they're going to have to modify or have an Alternative Link version of the implementation guides that accommodate that qualifier. So this is something that at some point Alternative Link is going to have to address with the DSMO's or with X-12 or both to have the technical infrastructure that will be necessary to run the pilot.
DR. COHN: Kepa, I think I agree with what you're saying. I don't think that that's an issue necessarily for the full Committee do you?
DR. ZUBELDIA: No, it's not.
DR. COHN: But obviously it's something that they need to be aware of. Obviously we will continue along with the discussions and let's sort of take a look at what we've got going for this year and just reflect on, it's January still, barely. It's time to sort of look at once again the issues for the Subcommittee and I tried to sort of put together an updated list of issues as well as questions and recognizing that we're already beginning to need to put together the, we are putting together hearing agendas for the remainder of this first six months. And we'll soon believe it or not going to need to start querying everybody for hearing dates for the last half of the year. I know it seems like we just started the year but I think we're going to need to get some dates ironed out.
Now I have here basically nine issues, and I just sort of want to read through them, Jeff I will obviously read them and I think we'll just sort of talk about them one by one, sort of see, with the question is being what do we need to do this year about it?
One, of course, is tracking the implementation of HIPAA administrative and financial rules, as well as of course issues around security and identifiers. And then really the question first of all is what do we need to do in 2003 to help assure successful implementation of the administrational and financial transactions final rule, knowing that that's coming up relatively quickly here in October. Questions, comments from the Subcommittee or our staff?
DR. ZUBELDIA: Are you going to read all the issues or are we going to go one by one?
DR. COHN: Why don't I read all the issues and then we'll go back, I think that they may make sense. That's the first issue, and then what do we need to do. The second piece of this is what do we need to do related to security and other HIPAA issues, which is probably a secondary issue at this point.
Item two is obviously the changes/updates to current standards and new standards, which have included the well known yearly report from the DSMO's as well as other requests for changes and modifications to the HIPAA standards. And that's become sort of a yearly discussion with the DSMO's.
Item three is electronic signature and the question here is really what, if anything, do we need to do in 2003 around electronic signature. If you'll remember about a year ago we had a number of discussions about that. I was reflecting that I hadn't heard anything in the last 12 months.
DR. ZUBELDIA: We had an interesting report yesterday during one of the PMI panels on authentication.
DR. COHN: On authentication?
DR. ZUBELDIA: On authentication and I can talk about it later.
DR. COHN: Ok, fine. Item four is PMRI and of course our terminology standards work, and then the other piece here is working with the combined health care initiative, which will clearly be an ongoing thing this year.
Item five is ASCA and the Administrative Simplification Compliance Act requirements. We have two bullets there that are still pending, which one is of course the analysis of a sample of compliance plans and the other is publishing reports on effective solutions to compliance plans identified, and we will observe that the person who was working with us around the analysis has since left the Subcommittee, so we need to obviously put some more focus on that.
Item six is a pretty big area that we've been working on this year. The first piece is, I mean code set issues, the first code piece is ICD-10 and we're going to be overseeing the cost benefit study this year. There's ongoing, not going, but residual issues from DSM and I know I just recently saw an email that was sort of like a question as in well what's going on with clarifications about DSM four. We've just talked today about complementary and alternative medicine. There is still an issue I think that we had from early in the year around HCPCS and the relationship between the HCPCS National Panel and CPT around coordination, and assuring that there is good coordination between the two bodies. And then finally it's the local code set issues, which we were being reminded of today as we saw some of the testimony.
Item seven, I guess there really are only eight issues here since I jumped a number, is letters for the full committee on NPRM's, sorry about that everyone. And of course that's contingent upon that we'll actually have some NPRM's this year to comment on, but those are one of our responsibilities.
And then something we'll be hearing about tomorrow is the issue of improving the HIPAA process.
Now we all know that we have upcoming meetings, we have a March 26th meeting, which will be a breakout from the full Committee, which will be a couple of hours long, and I'm actually sort of positing that maybe by that time we'll be able to talk about the ICD study update plus whatever else needs to happen. We have a full set of hearings March 25th and 26th, which will be diverted to PMRI work plus hopefully some time for some other discussions around other things that we feel are important.
We have a May 21 and 22 meeting where at least I guess we've held time for potentially a report on ICD and it is in terms of that study, and then a determination of what we need to recommend to the full Committee. And hopefully they'll be time for other PMRI work as well as if we've got additional time the issues of the administrative and financial transactions implementation.
Anyway, should I start at the top? Anybody feel overwhelmed enough? Oh, we forgot one. Karen, please. Oh, enforcement and compliance. I had taken that off. Should we put it back on? Enforcement and compliance. Or is there going to be an NPRM on enforcement? Ok, we'll add that as one of the NPRM's.
PARTICIPANT: For number six, you also need to add dental codes.
DR. COHN: Thank you. So CDT. Ok. Now is there anything else we've missed?
MS. PICKETT: One other thing and I guess I should direct this to Karen, Karen was there any other issues related to vision that may be coming back to the Committee, or coming to the Committee?
MS. TRUDEL: Not that I know of.
DR. COHN: I think we're asking about vision codes or bring the microphone close.
DR. ZUBELDIA: At some point I think that the vision industry needs to, they've been making some noises like they need to get a standard code set for vision to compare sooner or later.
MR. BLAIR: When you say vision you're really referring to optometry codes, not ophthalmology codes.
DR. ZUBELDIA: That is correct.
DR. COHN: Actually I thought we were talking about optician codes.
MR. BLAIR: Optician, it's optometry.
DR. COHN: Well, no, optometry I think is handled I think. I think we're talking about eye glass prescriptions and --
DR. ZUBELDIA: Eye glasses, contact lenses prescriptions.
DR. COHN: So I think we're talking about the optician codes. Ok, anything else before we start at the top again? And Stan we really want to thank you for joining the Subcommittee, hopefully after this meeting you'll still want to stay a member of it.
Anyway, I think that, we'll start number and I think it's rightfully number one, which is really what do we need to do in 2003 to assure successful implementation of the administrative and financial transaction rules. And obviously I think that has got to be our main responsibility this year, obviously balancing with everything else, and the question is, is what do we need to do, and what do we see as the issues. And we'll obviously be hearing some more tomorrow, but I want some input from the Subcommittee in terms of their thoughts on this.
DR. ZUBELDIA: Being an advisory committee I don't know there's much that we can do.
DR. FITZMAURICE: Well, there may be some things. I know that there are things hanging in the fire. We've had reports to NCVHS that we expect the standards out at some time. We've had publications of December 27th. Maybe we need to ask for information about are there some issues that the industry didn't see fit to cover that, or forgot to cover that NCVHS didn't hear about in the hearings that are important for making decisions that we could provide some assistance with. Maybe having a mini hearing or something to settle some issues that may have come up that we don't know about.
DR. COHN: Ok. Marjorie?
MS. GREENBERG: This seems to relate very much to number five because under ASCA, the Committee is supposed to, or oversee if not directly themselves, publish reports on effective solutions for compliance problems identified. So that seems to me the main the thing, a major thing the Committee is expected to do to help assure successful implementation.
DR. COHN: You know, Marjorie, you're right. I guess, and truly you see them separated here and they shouldn't be. I think the frustration that I have is, is that unless there's really something different that comes out of the data from ASCA, I think the issue of the compliance problems identified, the ASCA database may not be the source of really identifying compliance problems. To me that's really sort of the issue, is that if we identify the compliance problems then we can sort of figure out what maybe needs to happen. But I don't know the ASCA database is really going to be helpful for us.
MS. GREENBERG: It's not going to identify compliance problems.
DR. COHN: Well, that's the question I have. We obviously haven't done the analysis but when I looked at the nature of the questions being asked, or even our introductory conversation at our last meeting, it didn't appear that we were really being led down a really useful path. Karen, do you want to, do you have any comments about that? No. I think you're sort of agreeing with me on that one, that this is unfortunately I think the reality of that particular database. That we can divide and slice it in many ways and we do need to, but I don't know that it's really going to give us the burning issues.
MS. GREENBERG: So in that sense, is the Committee, I think the Committee has to make some kind of statement on this, so are you suggesting that maybe the Committee will say we did it, we looked at a sample of the plans or we looked at an analysis of the plans but they really didn't tell us anything.
DR. ZUBELDIA: Well, there are some things that the database has told us already. The fact that a lot of the providers are waiting for their vendors to give them a system that will help them become compliant, or the transactions. The amount of money that they're spending, at least some general idea of how much or how little they're spending. But I think there's very few things like that that the database has given us, not enough to really help the industry with some recommendations.
DR. COHN: And admittedly we haven't completed the analysis, at least to my understanding, which is obviously, I'm writing that down as something we should be expecting probably in February because we do not to make sure that there isn't anything more there than I think that there is.
MS. GREENBERG: I think we're going to have some representatives of WEDI here tomorrow, we can engage them on, I think we always talked about working through WEDI, to maybe disseminate best practices or whatever. It just seems that we can't completely ignore the request that the Committee do this.
DR. COHN: Oh, I agree.
MS. GREENBERG: But the good news about the extension request was that it was easy to fill out. The bad news was it didn't really say much. Didn't require much information.
DR. COHN: Steve?
DR. STEINDEL: Simon I'm probably going to have to turn in my resignation after I make this comment but I don't think there's much we can say about the implementation of HIPAA until the final rules come out.
DR. COHN: Or the modification?
DR. STEINDEL: The modifications and the final security rule. And it's difficult to talk about what constitutes successful implementation, I think that was shown in the ASCA database to a certain extent because we were looking at a cart and a horse situation. The plans, the providers were waiting on their vendors, the vendors were waiting on the final codification of the regulations before they made the changes in their system, it can it to the people to use, and that's what I'm concerned about. And there's really nothing we can do about that part of the process, we've done all that we can.
DR. COHN: Well, I agree with you about the administrative and financial, you mention security in the same breath.
DR. STEINDEL: Security, too, is sitting in the same, what do we need to do related to security and other HIPAA rules. Security is sitting in the same position as those rules, it's been awaiting final approval any day now, for how many days?
DR. ZUBELDIA: Years.
DR. FITZMAURICE: Well, I do suggest that we ask and see if there are any issues that we could show some light on. It might be a brief flutter from the chairman saying we offer you the opportunity at our February meeting to have us address any issues you think that will come up since we last referred it to you on the HIPAA transactions and the HIPAA security.
DR. ZUBELDIA: Well, we're going to have that opportunity tomorrow, to have an information discussion with WEDI and other industry leaders. There are some issues that I know will come out tomorrow.
DR. COHN: Maybe from just being reminded that we do need to finish up the analysis, but clearly we do need to talk to WEDI people and other industry representatives, because I think that, as Karen and I were talking, obviously I think one of the big issues, we're not in a position now to sort of fix problems, I think the time has passed where we could go through are reasonable rulemaking process for identifying, for solving problems identified, but it's really more if there are major issues that are occurring out there in the industry we sort of need to alert people about them.
DR. ZUBELDIA: I think that we need to listen to the industry very carefully with what are the issues that they're encountering. I know that there are issues that have been brought up in the Internet discussion meeting lists, and there are some issues that keep coming up periodically in those lists, and this I'm sure will come up tomorrow. That is probably going to give us as much or more information than what we can get from the ASCA database. Once we find out what the issues are, what can we do about it? That's a different story. I can rattle a few issues right now that I don't think we can do anything about. The fact that the implementation guides, even with the addenda, still have errors in them. And probably they will never be perfect, but who's going to resolve those discrepancies, who's going to resolve those interpretations of the implementation guide? Certainly not NCVHS. So that's why I'm saying that perhaps there's nothing we can do about it other than maybe recommend a resolution process or things like that.
DR. STEINDEL: With regard to what Kepa was just saying, from what I understand the DSMO process was instituted in part to look at some of these issues and I think we should look at how to improve that process, so that some of the issues can be resolved at that level efficiently, and a resolution mechanism would probably be a very good idea in that area.
DR. ZUBELDIA: There's has been an X-12 group working on a resolution process, not necessarily in resolving the issues but defining the process by which the issues will be resolved. And that got started in October. There's still no process and by the time the resolution process is defined and the issues started to be resolved, it's October.
DR. STEINDEL: Maybe we can help influence the process to create the process.
DR. ZUBELDIA: They already hate us as a result of the fast track of the addenda, if we try to impose another fast track on anybody, they'll just set this house on fire.
DR. COHN: I guess I'm beginning to be persuaded that we need to listen very carefully tomorrow, and sort of see what sort of issues are beginning to come up. Is it reasonable that we make sure at all of our sessions, once again we'll know a little better after tomorrow, but I'm sort of thinking that we need to reserve some time, probably at every one of our meetings between now and the implementation to at least sort of have people come in and talk to us, if there are any sort of major issues that we need to be aware of, be alerting the Secretary, too. Obviously Karen is sitting here, alerting Karen to and the CMS office or otherwise. And is that a reasonable sort of plan with the idea? I guess what I'm wondering is we spend a fair amount of time in the privacy subcommittee, this last year really going out into the field and sort of seeing what the issues are. Now I don't know that I feel that we necessarily need to do that, but it really does give one some thought about whether or not there needs to be some sort of a major effort, but it may be at this point a little premature to start making something like that happen.
I don't see anybody raising their hand going off to local environments. Yes?
DR. FITZMAURICE: It also strikes me, we're having WEDI coming in partly as industry representatives but within the government we have the largest health plan in the world, we might want to also invite CMS to address, to tell us what implementation plans or difficulties that they're having to match the industry. And if they all have the same issues maybe there's a way of either resolving them or dealing with them. You mention the implementation guide, that's something that's got to affect everybody.
DR. ZUBELDIA: I agree with that, I think that we need to listen very carefully to CMS as to what issues they have, and to Medicaid's, different state Medicaid's have very serious issues, too. I'm aware of some slightly out of line implementations of HIPAA that need to be addressed, because if they have issues of that magnitude we need to make sure that we do whatever we can to help the industry address the problem. And we need to talk to assisting vendors, that at the end are programming these transactions into their system and what issues they're finding.
DR. STEINDEL: I agree fully with Kepa. I'm looking at the schedule and saying when are we going to fit this in before implementation.
DR. ZUBELDIA: The timeframe for implementation has been reduced to six months, because without the addenda, which are necessary for implementation, people are just waiting, and they're going to have to do the entire implementation in six months, and that's very, very compressed timeframe. And that's an issue for everybody.
DR. FITZMAURICE: It is difficult. They're supposed to be testing their systems by April the 15th as I remember it and they have to know against what to test it. That is a big loggerhead right there.
DR. ZUBELDIA: Well, they have to know what to implement first before they start any testing. But we have some addenda to the implementation guides that were published because they correct changes that are necessary for implementation and the final rule and the addenda hasn't been published yet. And they're not like starting from scratch, if you've already implemented the May 2000 version, and then you implemented the addenda, and it's an incremental step. But if they need to take that incremental step, deploy it to the covered entities which are the providers, so the providers can start testing something by April 16, to put it in perspective there is one of the largest practice management vendors that took three years to deploy their Y2K batches, or their Y2K changes, because they have so many installed sites. And that didn't require testing with any trading partners, it was just a self contained Y2K upgrade. It took three years to deploy. They're going to have to do something for HIPAA in six months.
DR. COHN: I'm just sort of making a note here, and I'm, obviously I think we're all hopeful that by the time the full Committee meets in February that we'll be seeing the modifications to the final rule and hopefully security, but at least the modifications to the final rule. I guess one of the things that I'm just sort of noting is that I think we need, even though I'm sort of getting a little tired of sending letters to the Secretary saying this process isn't delivering rules on a reasonable schedule, we may need to keep in the back of our minds if for some reasons it hasn't been released by that time, probably there needs to be something sent in writing to the Secretary sort of alerting them of the danger of the implementation. But as I said hopefully, I don't expect that that will be an issue, but just in case.
DR. ZUBELDIA: My red flags are all up because in order to have the 180 days before October 16, the final rule for the addenda has to be effective by April 16, and if Congress is going to take 60 days to review that, then it needs to be published in the Federal Register by February 16, which is in the next two weeks. And if it doesn't get published in the next two weeks and Congress does in fact take 60 days then the industry won't make it on time and the 180 days will push the compliance date for the addenda past the October 16, and therefore the industry would have to technically to comply with the law implement the May 2000 version for however many weeks it takes to get to the addenda time.
If it's not published in the Federal Register in the next two weeks, and Congress does take 60 days, which they could take 30 days, I don't know what it will be.
MR. BLAIR: Maybe a telephone call is more appropriate.
DR. COHN: I guess the question is on this one just, Karen I think appropriately and I think we're sort of saying yes, we obviously know the timeframe. Is there anything that we should be doing right now? My thought was to, as we think about a letter that may be come out of tomorrow, do we as this as a stern issue if we need to put it in or not, or, the other option is that we prepare a letter, have the Executive Committee review it on an emergent basis and try to get it out in the next week or so, which is obviously another way of doing all of this stuff. I guess, Karen, I apologize, I don't have a clue about whether, what is our expectations of when these things will be out, or do we even, do you have any sense of that?
MS. TRUDEL: We've been in touch with the Office of Management and Budget on an almost daily basis talking through their comments, so I'm very hopeful that we'll have both of those regulations published really soon. But I guess my point about assessing this list of issues is that there are reasons why the Subcommittee wants to address things. They want to address things because they think there's a need to provide the Secretary with information, or provide the Secretary with recommendations, or there's a need for the Subcommittee itself to keep on top of something because of the requirement to do the yearly report, or just the need to make sure that we're constantly measuring, keeping a finger on the pulse of how things are going. And I guess my question about each of these nine items then is for which of those three reasons is there a need to look at things? Electronic signature there may be a need during the year to provide additional recommendations to the Secretary. In terms of tracking, is the intent to track possibly with the idea of sending recommendations to the Secretary or are we in a time loop where that's almost too late and that the Subcommittee is doing it to keep a finger on the pulse. I think that's an important thing to think about.
DR. ZUBELDIA: Karen, my impression, and I may be totally out of line here, but my impression is that if the addenda/final rule doesn't come out in the next two weeks, whether we like it or not we're going to have to recommend to the Secretary to postpone the October 16 date, because if the addenda doesn't come out on time for the industry to comply, to force the industry to go through two versions within a period of months will be extremely disruptive.
MS. TRUDEL: But I believe the addenda will come out on time.
DR. ZUBELDIA: That's what I'm saying when we're tracking implementation. Having that as a front of our eyes to make sure that if it doesn't come out for whatever reason that we react very, very quickly because it will be a very drastic measure and we'll have to react quickly to it.
DR. COHN: I think I'm actually hearing out of this conversation that it isn't so much that we need to send something to the Secretary saying hey, it needs to come out in the next two weeks, it's more if it isn't out by our next full Committee meeting we need to send out something very strongly to the Secretary saying you need to slow down the implementation.
DR. ZUBELDIA: It needs to be to Congress.
MR. BLAIR: Simon, my inclination is that we limit our letters to the Secretary to things that can make a difference, and I think to send a letter saying oh by the way the date is getting close, I just don't think it's worth our time, and I particularly don't think it's also the kind of precedent we want to send.
DR. COHN: I think we've sort of talked through this a little bit plus I think, as Karen commented, I think we're trying to keep our pulse on what's going on to identify any major show stoppers, any major issues, which are really to sort of try to alert the Secretary and the government about issues that they maybe deemed to ward off. As I remember in HIPAA, there's actually some emergency authority that the Secretary has and if there were something quite on that level we would obviously need to notify or advise.
Now a question is, is there anything else on the other rules that we need to be dealing with, thinking about, obviously we know that they're all sort of in process in the government at this point, either as final rules or as NPRM's. Michael?
DR. FITZMAURICE: I think on the attachments, we heard earlier this week at the NHII testimony, we were urged to adopt an electronic signature as a requirement for one of the attachments so as to drive the electronic signature field. I'm not sure that that is a high level reason, the reason you'd want it there is because you need a signature and electronics makes it easier and cheaper to do. But that may be something we may want to look at and reaffirm or change our decision in a recommendation that we still see no standard out there for the electronic signature or we do see one. So that's a decision we may want to advise on in the coming year when the attachments either are about to come out or after they come and we want to make a comment on them.
MR. BLAIR: Glenn Marshall testified, was it yesterday or the day before?
DR. ZUBELDIA: Yesterday.
MR. BLAIR: Things blur. He went through the status of the efforts of that group that we had encouraged to work together under ANSI HIS with ISO standards and ASTM standards and working with HL7, NCPDP, to all see if they could agree on a common electronic signature. And essentially he indicated the status of that was lack of funding, the fact that they hadn't gotten to the point where they could really implement many of those to wind up finding out if they work and lack of a sense of urgency from the vendor community, the user community. Did I misspeak, did I leave something out?
DR. ZUBELDIA: I would add something. That he essentially said that the vendor community is not ready to take the leadership on this and he wanted the government to adopt something that will be taken by the industry and run with it.
MR. BLAIR: And I sort of feel like it's almost like pushing a wet noodle, because if those are the groups that are finding that they can't push it forward, if they don't see an urgency to do that, I frankly don't feel as if we're going to be very effective in pushing them, even if we may want it to go forward. I do think that this is an important topic, Simon, that we have on the agenda, and my frustration is he gave us some recommendations, now that was in the framework of the National Health Information Infrastructure as opposed to our Subcommittee, but nevertheless, I don't think his recommendations would change that much if he was speaking to us directly. And I just don't know how much of his recommendations are actionable at this time. So I'm not sure what to do.
DR. COHN: Well certainly last year we haven't done anything, so that's one answer always. I think that on this, and I'm just sort of looking back and forth at you having not been at the hearings yesterday, but if it shows up in a claims attachment piece, then I think we better take a really hard look at it pretty fast. But if it doesn't, then not hearing that the industry has a business case on it, given that our plate is full, given everything else going on, I think we probably just ought to take if off the platter for this year.
DR. ZUBELDIA: Essentially what he wants us to do is push it forward, and even if it doesn't come out in a claims attachment, to recommend that as a security measure all attachments should be signed, even though that signature may not necessarily mean a signature as an acknowledgement. It may just be a security measure, but he said that if the mechanism is in place to have all the attachments signed, then the signature will be used for all things.
MR. BLAIR: My thinking is that until we have an NPRM on claims attachment, there's not much for us to hook it to. Once that NPRM does come out, I think we could raise this issue, ask for action plans, ask for people to report back, do things to facilitate and encourage, that it be done. I think we'll have some leverage once that claims attachment NPRM comes out but before then I don't know what leverage we have.
DR. COHN: Michael and then we move onto the next issue.
DR. FITZMAURICE: I've got to agree with you Simon, and it doesn't even pay me to do that. That if the business case has not been made, if the people in testimony about implementation issues, and even if they talked to us about attachments, don't say we really need an electronic signature then it's probably not the time to put it forth. If it comes forth in an attachment, then that will be a trigger to ask for responses to the testimony, but I don't see anything for us to initiate at this point. And I think I see Jeff's nodding his head, I think that that reflects what Jeff said as well.
DR. COHN: I think we're going to hold on that one and we'll take a look once we see the claims attachment, and if indeed there's something about it, we could actually even run a letter back to the Secretary maybe make a note about it or whatever.
Ok, PMRI, Jeff, obviously we've got the terminology standards work going on. Remind me again very briefly what the hearings schedule is between now and, how much of all the hearings are you taking between now and June?
MR. BLAIR: One full month. Simon and I and Steve and Suzie have kind of discussed some of these things, a little bit more than I have directly with the rest of you all, although we do have a work plan that you might have seen, but I'm not sure. So I'd like to kind of review some of the generalities of the work plan, and I'm not proposing that we change it, but I want you to know its limits, because you may wind up saying gee, that's a concern, we need to think about that. And there's one area that Simon and I have talked about which might become a concern in the March or May timeframe. And at this point we're waiting to see whether it does become a concern before we specifically address it. But let me run it by this way.
I think everyone knows that our vehicle to gather information from the terminology developers, the PMRI terminology developers, was sent out on the 6th, which gives the terminology developers just short of six weeks to respond to it. That's a much more aggressive timeframe that we had for the PMRI message format standard questionnaire. And that's only going to leave, by the way the due date on that is February 14, Friday, February 14, the last day of HIMS, or the day after HIMS. And that leaves Walter Sajansky, our consultant, only five weeks to compile and analyze and come up with recommendations for us for the March 25th, 26th Subcommittee meeting. Tight schedule, and that's one of the reasons that we don't have anything on PMRI in this Subcommittee meeting or in the full Committee meeting, it's because it's sort of falling between those activities.
Now the information that we hope to get from vendors we would get in the form of testimony on that May 21st, 22nd meeting. And we don't actually have another meeting for June, July, except that I think we're going to maybe have possibly a meeting in July to review the first draft of recommendations. The June timeframe in the contract that we have with Dr. Sajansky does allow him time, if we need it, to seek additional input from industry experts if at the end of the May timeframe we need additional input, but it doesn't call for a Subcommittee meeting for testimony.
Let me mention the areas of concern that I have. And I hope that they are manageable within our current construct. We don't know how many terminology developers will give us responses by the 14th, we have over 56 names that we sent out, I think over 30 developers, and we think we have pretty good coverage and Suzie and I and Steve also has made efforts to verify that people received the questionnaire and that they understand that it's going to take a bit of time to fill it out. So that work has been done.
There was one terminology developer that seemed to have the expectation, that may have gone away now, that they would have the opportunity to testify to explain to us the value of their terminology. I think that's gone away. Now please understand that we have not scheduled time for terminology developers to separately testify on behalf of their terminologies. This is consistent with our practice with the message format standards. We did ask for input before we created the message format questionnaire, we asked for critiques on the questionnaire, and the same thing with our terminology questionnaire, we sought input before that questionnaire was developed in August, and the thinking that I least I have, so I'll just speak for myself right now, is that the questionnaire is comprehensive, and I think it's going to be a very good vehicle for us to be able to analyze the capabilities of the terminologies. My feeling is that additional testimony from terminology developers is not likely to help us a great deal.
However, if on the 14th or that subsequent Monday we hear from one or more terminology developers that they are concerned that the questionnaire does not allow them to fairly, to get a fair hearing or get a fair consideration, then I think we're going to come to a decision point. If two or three, one or two or three terminology developers ask for this, I think it would be unfair to have only them testify without having all testify. I'm not sure, and that would virtually be at least a full day, people, but that's only about 30 developers. That would be a full day. And my hope is that they do not request that, ok? So far, we don't have a request. But one of the things that are options for us, if that does happen, is that on the 25th, 26th, we might expand the day of the 26th maybe to a full day to get some extra time for testimony if that's going to be needed. Or that we tack it onto the May timeframe. I hope this is not necessary but I'm mentioning it as a possibility if the issue arises.
Right now it is my assumption that Walter is going to have quite a lengthy presentation for us on March 25th, and it's going to take us a while to digest it, we're going to have a lot of questions to ask, and we may have questions where he may need to go back to some of the terminology developers in the April timeframe for additional information to clarify certain things, and report back to us in May.
The last thing that I might mention in terms of this work plan, is that the work plan now calls for three drafts of the final recommendations. The first one in July, the second in August, and the third in September. That's targeted for us to give our final recommendations and get it approved by the full Committee in September. So that is our target.
So now that I've reviewed this, does anybody have questions or concerns?
DR. COHN: Anybody have any concerns?
DR. ZUBELDIA: If they do want to testify, it's going to take at least two full days.
MR. BLAIR: I don't think it's going to be two full days, it also depends on --
DR. ZUBELDIA: How many can you pile into a panel?
DR. FITZMAURICE: We may want to schedule something in the summer.
DR. ZUBELDIA: In Hawaii?
MR. BLAIR: We'll also have to see what the nature of it is. So we just, I don't think it's going to take two full days anyway because we may only have 20, 25 terminology developers that have submitted stuff. And that can be done in a day, we'll just have to see.
DR. STEINDEL: Jeff, I think if we do get any questions coming from the terminology developers after they return the questionnaire, I think what they should do is discuss their concerns and expand with Walter. And have Walter bring that to us with his report in I guess it's March, and I think we should discourage at every possible way any formal testimony from the terminology developers. And I think one thing that we should set here and now is if there is a hue and cry for testimony, that we are going to have a five minute time limit.
MR. BLAIR: Well, Steve, I'd probably maybe pick slightly different words, but the result is somewhat the same, is we haven't invited people to testify and I've left it open. If somebody does ask to testify, I think Walter and I will wind up trying to understand what it is they feel they need to communicate where they'd need to testify, see if it could be done in some other way. If it can't, then we deal with it. But essentially I'm agreeing with you.
MS. TRUDEL: I think just historically remembering past hearings that we've sent up, I think 20 minutes is, 20 testifiers is about the most we've ever been able to pack into a day, and at the end of the day what we usually get in terms of feedback from the Subcommittee members is something along the lines of I feel like I've been drinking out of a fire hose. I think Steve kind of has a point and that is that if the people who are completing the written documentation know that they need to put their case in there, because there's not going to be another opportunity, I think will foster people being careful and making sure that they take the opportunity to craft the document, the survey, in such a way that they say everything that they need to say.
MR. BLAIR: And I think we gave them opportunities with the questions in the questionnaire, that they really have the opportunity to do that. I frankly don't think this is going to come up, I wanted to mention it so that everyone was aware of it. I also wanted to mention it just in case there's somebody on the Subcommittee or staff that disagreed with the intent, the way we're doing it.
DR. COHN: Steve, you had a comment, and then Suzie.
DR. STEINDEL: I think Karen pretty much addressed what I was going to say.
MS. BEBEE: I wanted to share some of the feedback that I'm getting so far which might address some of this. I think first of all we were very proactive when we started this. I talked to most everybody that Jeff sent the questionnaire to, and the response has been nothing but positive. People were ready, willing and able to fill this out. And not just one person, but talking to several people to work as a collaboration to fill out the questionnaire. Some questions I've been getting is how many people can help fill it out, how many questionnaires can I fill out. For instance, home health and nursing wanted to fill out two questionnaires. Can I comment in free text? I want additional comments and they're not necessarily covered by the questionnaires. And some of the things that have come up, one thing that has been an issue that I felt it was a policy issue, my terminology won't work unless it's with that terminology, so let's stop this process and let's set up a conference call and let's talk about it before I fill out the questionnaire. And that was fielded and stopped. So the issue of filling out the questionnaire and then adding the free text component seemed to solve that problem. So I haven't been getting any negatives, nothing but positives.
DR. COHN: That sounds good, I mean the next obvious issue is the CHI. I mean we're ok with the PMRI for the moment? Obviously the CHI group, which obviously is moving pretty rapidly at this point, we'll obviously have a presentation from the full Committee in February, but we're going to want to keep close connections. I presume that they're going to want to participate with us during the testimony and hearings in March and all of that.
DR. STEINDEL: We're here.
DR. COHN: Now, next item is the ASCA piece, and I guess I'm, based on our earlier conversations I think we need to figure out some way and I'm not sure, actually we'll look to Karen or look towards NCHS staff, but I think we need to complete the analysis of the ASCA database and have that ready to somehow present, and I don't know, I'm a little concerned I think that CMS, Karen and others are I think overwhelmed at this point. So the question is is do we need additional, someone else to take a look at this --
MS. TRUDEL: It's my understanding that we've just within the last few days gotten the completed and unduplicated database back to work with. If someone else is available to do SAS runs or something like against it I would be more than happy to turn that over and I actually think Steve at one point you volunteered to do that.
DR. STEINDEL: I'm not here. Yes, I'd be happy to, Karen.
DR. COHN: So Steve we can put you on the line for a sort of evaluation and report. Mike, are you going to say something, too? No.
DR. ZUBELDIA: Do we have to draw conclusions from the ASCA database or can we merge the conclusions with what we will hear tomorrow for instance?
DR. COHN: I'm hoping that we can merge them, I think we'll find some things from the ASCA database we need to do it, but I think we're going to be getting a lot tomorrow, I hope.
MS. BEBEE: Are we going to share this with anyone other than this Committee, Subcommittee? In other words, some conversations, not many, that I've had the industry has expressed an interest in knowing what the results of these are. So I hadn't thought of that and I wondered if, from my question, whether or not we had thought about sharing it outside of this room.
DR. COHN: Well, this is a public forum, so this is certainly not a private discussion we're having. Karen were you going to say something?
MS. TRUDEL: A number of people have asked for aggregated numbers, I know the American Hospital Association is interested in knowing how the hospitals are coming out. And we certainly could post some of those statistics either on our website or on the NCVHS website. And we had talked about when we get to a point where we identify best practices the idea of publicizing or publishing them, which is what was in ASCA, that we could meet that requirement by putting some links on the NCVHS website.
DR. COHN: And obviously we'll see what happens out of tomorrow and the analysis, there may be something that comes out of that, but we'll just have to see.
Now, obviously the publishing reports on effective solutions is going to obviously be contingent on identifying problems, so let's sort of see what problems we come up to and we can sort of go from there.
DR. ZUBELDIA: WEDI SNIP has identified a lot of problems and they have prepared a lot of reports on different aspects of implementation, things from translators and the role of translators and the role of clearinghouses and issues with code sets and so on. Are we going to somehow incorporate those reports or those findings or potential solutions into our solutions or how are we going to address that?
DR. COHN: I think my hope is that we'll be able to either, as we identify the problems we can sort of say look here, look there, either with a link or just with something that sort of says go to that website and look there for some further suggestions around this. Obviously we have to get permission of WEDI SNIP before we do that, but I think that was sort of I think our thought at least for some well known resources. Are you comfortable with that?
DR. ZUBELDIA: Yes.
DR. COHN: Now, let's talk about code set issues, I'm sort of hoping that we're going to rev up here a little bit. ICD-10, my understanding is we're getting close to the initiation of that of that project, and hopefully in February we'll be able to during our breakout we'll be able to at least get an update on where we are with all of that as well as issues and all of that. Are we still working towards May as a conclusion to that project?
MS. AULD: We have a date.
DR. COHN: The date's for, I'm just concerned because obviously we're almost into February now.
MS. GREENBERG: This has been, the scope of work basically the whole thing was kind of a done deal right after the first of the year but then we are in a bureaucracy.
DR. COHN: I know. Ok, as long as we're ok with the end dates, that's fine. DSM, Donna is there anything to report on that one?
MS. PICKETT: Well, we know that legal is looking at the issue, it has been looked at by at least one of the offices and has been referred on for additional opinion, so hopefully by the next meeting we should have some information, if not sooner.
DR. COHN: The other obviously complementary and alternative medicine we've just spent much of the day talking about, and I think we're looking towards an update probably sometime late in the year. HCPCS panel and the issue of coordination with CPT and all of that, we're really actually looking for a report back from the HCPCS panel, and I don't know, not close, ok. So we'll just sort of keep that as sort of a pending when they're ready.
And then local code set issues which sort of are along the lines of tracking implementation. I don't know if the Medicaid issue is really much different than the local code issue. No comment, ok.
No, obviously improving the HIPAA process, dental codes, I'm sorry, I wrote it down and then didn't comment. Dental codes, what are the pending issues on dental codes?
MS. AULD: I was asking if there are any outstanding issues and whether it needs to be addressed here or not.
DR. COHN: It's been quiet there recently, I think we're going to be seeing Frank Pocornie(?) tomorrow for other issues and we can certainly ask him what the status is at that point. But we can also, we'll also put that onto something just to inquire about. Vision codes, obviously we're sort of saying maybe there's going to be something there. When last we looked they hadn't quite, they were working together.
DR. ZUBELDIA: There's a lot of proprietary codes and apparently not even one standard code set that could be adopted for vision codes.
DR. COHN: Ok, obviously the next item is the whole issue of NPRM's, which we'll respond to, I'm sorry, Steve.
DR. STEINDEL: I have a question on the code sets, what we just heard about today we had a mention that we would need another follow-up hearing, are we thinking about that the first half of the year or the second?
DR. COHN: No, the second half of the year, probably late in the year.
DR. STEINDEL: Then I have no question.
DR. COHN: You don't have any question, ok, I just don't think there's time in the first half of the year, and I'm not sure that they'll be a whole lot more information either. Basically our letters, we'll respond as proposed rules come out. Finally improving the HIPAA process is an issue from, that we'll be talking about tomorrow. I guess my hope is is that we'll have something that we want to share as that session finishes. Suzie?
MS. BEBEE: Back to number seven about the NPRM's, there's an activity going on within, something that we will want to look at that's happening within HL7 right now in the attachments, the workgroup is currently looking at a possibility of changing the structure of the attachment, so that it would be XML, and so they're exploring that with the possibility of commenting during the comment period. There's a couple of avenues that they're exploring but that certainly is a big change that we'll probably want to follow to see if things develop.
DR. ZUBELDIA: Are they looking at having both in the comment period?
MS. BEBEE: You mean both versions?
DR. ZUBELDIA: Both versions, an XML version and a 2/3 version?
MS. BEBEE: Yes, they're looking at that as being a possibility. In other words, they're looking at recommending that that be a possibility.
DR. ZUBELDIA: Did you look at number two?
DR. COHN: Did we look at number two? No, I actually didn't comment on it only because it's usually a year end activity. What is your --
DR. ZUBELDIA: The new standards, there is a draft for comment on the X-12 version 4050 and it's not just the standards that are currently adopted by the Secretary, there is additional standards that have been published by X-12 for comment. They are currently not HIPAA standards, new transactions, new transactions for things like coordination of benefits between two payers, or acknowledgement response to a transaction with better reporting, transactions that are important. NCPDP also has the NCPDP script that at some point we'll need to look at.
DR. COHN: We'll we've already recommended the script for --
DR. ZUBELDIA: We looked at it for PMRI, but some of these other X-12 transactions, not the script but the X-12 transactions are purely administrative transactions, they're not PMRI transactions. And at some point we need to consider them to see if we're going to recommend to the Secretary those transactions for adoption or not.
DR. COHN: Well, let me ask you a question, I agree with you that these are important issues, the question is is timing. And I guess I'd be concerned if we start holding hearings on those particular issues before the effective date of the final rule, we're going to confuse everybody. Now maybe I'm alone in that, I can imagine holding a hearing on changes to the X-12 version would be very confusing because there's no additional functionality, maybe I'm wrong about that one.
DR. ZUBELDIA: This is not changes to the X-12 version, this is new transactions for new functionality that has not been adopted by the Secretary.
DR. STEINDEL: I would like to hear a sense as to whether or not they should be recommended to the Secretary for adoption, I think there's a different word we might want to use, instead of putting it, adoption implies to me that it's going to fall into the regulatory process again, and I don't know if that's what we want to happen.
DR. ZUBELDIA: And perhaps instead of recommending to the Secretary we ought to have a recommendation to the industry to adopt the transactions without a regulatory mandate.
DR. STEINDEL: I'm looking for some type of approach like that.
DR. FITZMAURICE: Or perhaps we recommend to the Secretary that he endorse, rather than adopt.
MR. BLAIR: Well, I think what you're heading towards is very similar wording to what we put in our PMRI recommendation where we asked them to recognize the current standards for industry adoption in reflection to the industry investment in current standards, and if we want something to be improved, then we recommend the HHS incentives to accelerate the development of a terminology. It sounds to me like you're going back to that wording.
DR. ZUBELDIA: That could be a possibility. For instance the transaction that acts as an acknowledgement to other transactions, it's a generic transaction, if a payer receives an enrollment transaction, and 834 enrollment transaction today, the payer has no way of identifying errors and reporting them back to the submitter. If a provider receives an ineligibility response that has errors, coming from the payer, the provider has no way of reporting that back to the payer and saying this response was invalid. So this is an administrative transaction that can act as a control transaction and a lot of entities and industries are looking at that specific transaction, it's called 824, for adoption, even if it's not mandated by HIPAA.
MR. BLAIR: Again, you're going back to words that, when you say adoption I think that implies to a lot of people mandate.
DR. ZUBELDIA: No, for implementation without being mandated by HIPAA, and simply for the coordination of benefits, something that will benefit the payers to do by themselves without being mandated by HIPAA. And some payers are already saying that they're going to implement that transaction even if it's not a HIPAA mandate, because they find no other way to do coordination of benefits properly. So at some point perhaps we need to look at not recommending to the Secretary to adopt this as HIPAA transactions but perhaps recommend that the industry should implement them voluntarily and if the industry doesn't implement voluntarily then there may needs to be a regulatory mandate to implement.
DR. COHN: The question is this something we should ask some of the groups that are coming in tomorrow? This I think falls into that issue of how in the heck do we improve the process, and maybe it's a different view to improving the process, but some of it has to do with how we make progress in all of this stuff, and this maybe one thing we ought to see what the people think about.
DR. ZUBELDIA: And there is a related issue with the NCPDP transactions, where the NCPDP implementation guide adopted by the Secretary has a lot of optional fields, and there's a segment of the pharmaceutical industry that are saying they don't want any optional fields, they want situational fields, so they have come up with a new implementation guide that has situational fields and are trying to get it through the DSMO process and see how that's going to work. And that may be something that the industry does voluntarily, or we need to keep an eye on that because they may need some sort of regulatory requirement to go a transaction with situational fields instead of optional fields. There are some things that are on a lot of people's radar screen right now and I think they ought to be somewhat in the NCVHS radar screen.
DR. COHN: I guess we can talk about it tomorrow, it's hard for me to imagine that a new implementation of a HIPAA standard becomes a voluntary action. I think that that's something where if you suddenly start changing how you're handling the fields and the versioning and all this, it's a little more than that. That's just my initial sense, I may be persuaded otherwise, but I could image half the industry going to one way of doing it and the other half not, and that may not be a successful outcome.
DR. ZUBELDIA: That's why I'm bringing this up. On the NCPDP side, the NCPDP transaction has a lot of fields that are optional, they're either mandatory or optional. And there's a segment in the industry that are saying we are going to implement the optional fields this way, and another segment of the industry that says no, we're going to implement the optional fields a different way. And since there is at least two different ways of implementing the optional fields expressed by two different implementation guides, it will get to a point where perhaps one of them should be adopted as a standard.
MS. BEBEE: Isn't that going through the DSMO process now? So that should be resolved.
DR. STEINDEL: I think that's one of the issue that Kepa is alluding to about developing a process for reconciliation process, because it looks like that DSMO's conclusively resolve this issue and it may have to go to a reconciliation process.
MS. BEBEE: You mean an appeal process? That's part of the process.
MS. TRUDEL: It is, it is part of the process, and we have standards developing organizations with their own protocols, and we have the DSMO process which we've set up, and I think we owe it to those processes to play through. As far as making recommendations to industry to voluntarily adopt things, I know we've done that on the PMRI side, we've done it for really particular reasons. I think we need to keep in mind what the charter of the Committee is, which is to make recommendations to the Secretary, not to make recommendations to industry, so that's something, that's a distinction that's really important. And if the Committee wants to make recommendations to the Secretary and have him suggest to industry that standards be voluntarily adopted, I guess that's doable.
MR. BLAIR: That is what we did with the PMRI standards and I think the wording that we had was that HHS would provide guidance to the industry regarding PMRI standards.
MS. GREENBERG: Technically I certainly agree with Karen, but I would say through it's 50 some year history the Committee has made recommendations to industry, to the health data care field, and when it makes recommendations, it more than ever I'd say they health industry takes note but I think the real issue is the Committee's sense of, which is going to be discussed tomorrow, of the process and whether, and of course we won't know until implementation is, until we've had implementation of the standards. But whether in fact doing these types of standards, which are quite different I think than the electronic medical records standards on a voluntary basis is something that's like to be successful. I mean that maybe having gotten the jump start with all the required ones, maybe it would be. But I think the whole reason that HIPAA was passed was the administrative simplification provision was because doing it on a voluntary basis wasn't working. So I think that the Committee does need to think that through and have testimony or discuss with the industry and then make recommendations to the Secretary. That's basically a departmental decision if they want to go through rulemaking or not. But I also, if you really want everyone to use the same standard voluntary probably doesn't work. If you really want real standardization, and so although I said the Committee has been making recommendations to the industry more broadly, over 50 some year period I don't think it's resulted in everyone using the same standard exactly the same way.
DR. COHN: I think the reality is just looking at what we've got coming up over the next number of months. Obviously my concern was let's not confuse the industry by beginning to go off and sort of next step things before we got the foundation handled. And yet as I look at the agenda at what we're doing for the year, I don't think I have much worry of that actually, just in the sense that I think it looks to me like we're pretty well booked through September anyway. So it might be very appropriate for us to, we obviously need to hear from people tomorrow, begin to think about how best to ensure that standards get uniformly adopted with a minimum of hassle, which I think has been a big issue for the last seven years. But also it may be as the year goes on it may be very appropriate for us to look at what sort of new standards are appropriate and as I said, once again, once the dust settles a little bit I think people will be certainly interested in that. So let's sort of figure out how all that fits in.
Now I think we've actually gone through the items believe it or not. Maybe I'll feel better tomorrow about how to put all these things together into this year without trying to kill everybody with hearings, but we'll do our best to try to keep things reasonable. Certainly if any of you think about additional items that need to be somehow brought up or dealt with over the year, the issues, pages, always open for additions and deletions. But I think any final comments from anybody? Suzie?
MS. BEBEE: Just our collaboration with the other Subcommittee's. Just my thought of how we're collaborating with all this on our plate with the other Subcommittee's, how will that work this year?
DR. COHN: I thought you were going to provide us with some suggestions as opposed to bringing up a question. Marjorie do you have?
MS. GREENBERG: Actually, it could make things worse but I know that the Populations Subcommittee, that isn't on the list, identified some what they consider Standards issues that, and HIPAA related standards issues that they would have asked the Subcommittee to look at and I think that's going to be discussed again in the February meeting. So you can add that to the list.
DR. ZUBELDIA: I would like to coordinate things so we don't have very many weeks like this one.
DR. COHN: I will sort of comment that we were here first, if you think about it, and the other ones sort of tagged on.
DR. STEINDEL: Marjorie's going to make us T-shirts. We survived.
DR. COHN: I agree and maybe that's something we should talk about in February at the full Committee about rules about whether or not we start trying to put two hearings together and whether that's really convenient or not.
MS. GREENBERG: There are some members who like it and others who don't. Maybe they like it in anticipation, it's the same people that like it in anticipation that don't like it after it happens.
DR. COHN: The other issue which is this issue of how we work together with the Populations Subcommittee, which quite frankly I'm been sort of blanking on, did not immediately come to mind. But we might want to consider potentially utilizing some of the actual full Committee time, since the combination of both Subcommittee's makes up about 80 percent of the full Committee, that if there are really focused issues that we, there's nothing against getting some people in and actually holding some, doing some focused work on areas where there's sort of commonality of interest. And it might be a way to sort of save everybody's time and a lot of people that use time efficiently. So that may be a suggestion that we bring up for February.
MS. GREENBERG: That's a good one because even if they want to pass something over to you, you kind of need them there.
DR. COHN: I guess I'm less excited about the idea of passing, throwing things over the wall to other Committees. If they think it's an issue that's worthy of investigation but they don't feel they have the expertise to do it along, let's do it together. Anyway that's sort of my going in assumption. I see others nodding their heads yes that that makes sense.
Ok, listen it is now 5:07, I want to thank you all, we will adjourn and we will reconvene at 9:00 tomorrow morning.
[Whereupon, the meeting was recessed at 5:07 p.m., to reconvene the following day, Thursday, January 30, 2003, at 9:00 a.m.]