Hubert H. Humphrey Bldg.
Washington, D.C.
List of Participants:
Kathryn Coltin
Jeffrey Blair
Simon Cohn
Kathleen Frawley
Lisa Iezzoni
George Van Amburg
Bill Braithwaite
Marjorie Greenberg
Robert Moore
James Scanlon
Kathleen Weiss
Michael First
James Cross
Allen Pincus
Betsy Humphrey
Michael Hamm
Diane Dwyer
Deborah Nadzam
James Summe
Jean Harris
Kathy Huntley
Gail Graham
Catharine Burt
Marge Zernott
Donna Pickett
Reginald Harris
Robert Owens
Kent Alan Spackman
Judith Warren
Kathryn Bowles
Virginia Saba
Peter Goltra
Vivian Coates
TABLE OF CONTENTS
Page
Call to Order, Kathryn Coltin, Chair 1
Panel on Providers and Health Plans
Michael First, APA 2
James Cross, United HealthCare and AAHP 8
Panel on Public Health and Research
Michael Hamm, NAPHSIS 55
Diane Dwyer, CSTE 62
Deborah Nadzam, JCAHO 70
Panel on Federal Agency Data Users
James Summe, AHCPR 90
Jean Harris, HCFA 95
Kathy Huntley, FDA 101
Gail Graham, VA 107
Catharine Burt, NCHS 114
Panel on Developers of Coding and Classification Systems
Marge Zernott, ZKC Associates 143
Donna Pickett, NCHS 147
Kathy Huntley, FDA 161
Reginald Harris, AMA 168
Robert Owens, ADA 173
Kent Alan Spackman, CAP 179
Judith Warren, NANDA 187
Kathryn Bowles, OMAHA 198
Virginia Saba, Georgetown 204
Peter Goltra, Medicomp 214
Vivian Coates, ECRI 218
P R O C E E D I N G S [9:10 a.m.]
Call to Order, Kathryn Coltin
MS. COLTIN: Okay, we are going to get started. This is the second day of hearings being held by the Subcommittee on Health Data Needs, Standards and Security, of the National Committee on Vital and Health Statistics. I welcome you. We had a good day yesterday. I suspect we will have another one today.
My name is Kathy Coltin. I am with Harvard Pilgrim Health Care in Boston. I would like to start introductions. First those here at the table and then we will go around the room. Bob?
MR. MOORE: I am Bob Moore from HCFA.
DR. IEZZONI: Lisa Iezzoni from Beth Israel Deaconess Medical Center in Boston.
MR. VAN AMBURG: George Van Amburg, Michigan Department of Community Health.
MS. FRAWLEY: Kathleen Frawley, American Health Information Management Association.
DR. BRAITHWAITE: Bill Braithwaite from ASPE, HHS and staff to the committee.
MS. GREENBERG: I am Marjorie Greenberg of the National Center for Health Statistics and acting executive secretary to the committee.
MR. SCANLON: I am Jim Scanlon from HHS and I am executive staff director of the committee.
MS. WEISS: I am Kathy Weiss from the Agency for Health Care Policy and Research and I am staff to the committee.
DR. CROSS: I am Jim Cross. I am representing the American Association of Health Plans and United HealthCare.
DR. FIRST: Michael First representing the American Psychiatric Association.
[Introductions are made around the room.]
MS. COLTIN: Okay, we have two more committee members.
[Introductions.]
MS. COLTIN: Okay, we are going to get started. Our first panel is on providers and health plans and we will take the speakers in the order they are listed on the agenda. So, Dr. First, you are first.
Dr. Michael First, APA
DR. FIRST: I would like to use the overhead. My name is Michael B. First and I am a research psychiatrist at New York State Psychiatric Institute and the Columbia University Department of Psychiatry and I currently serve as consultant to the American Psychiatric Association's Office of Research which is responsible for DSM-IV and its maintenance and update. I am testifying today on behalf of the American Psychiatric Association which is a medical specialty society representing over 40,000 psychiatrists nation-wide.
The American Psychiatric Association has been committed to the development and dissemination of a standardized classification system for mental disorders since the mid 1950's and actually the process originally started with the 1840 census which was the first time that there was an attempt to determine the rough estimate of the number of people with mental disorders in the United States. The classification system which is known as the Diagnostic and Statistical Manual of Mental Disorders has undergone four extensive revisions, the most recent of which, DSM-IV, was published in 1994. Although it was developed under the auspices of the American Psychiatric Association, DSM-IV has been accepted by all mental health professionals and mental health care organizations as the standard nomenclature for the classification of mental disorders in the United States. It has also received widespread international acceptance having been translated in over 20 languages.
There are several unique features of the DSM system which distinguish it from other classifications of disorders. In order to maximize the reliable assignment of diagnostic terms in the classification to actual clinical cases, the DSM-IV provides specific diagnostic criteria. These standardized definitions incorporate both inclusion criteria that indicate the features required for the diagnosis, as well as exclusion criteria that indicate the boundary with other disorders in the classification.
The provision of diagnostic criteria has also made the DSM classification useful for defining study populations for research in that it allows researchers to define homogeneous populations in order to determine the causes of mental disorders as well as testing the efficacy of treatments.
Virtually all NIH-funded studies of clinical populations with mental disorders use the DSM for definitions and criteria. Furthermore, drug indications for pharmaceutical companies for pharmaceuticals approved by the Food and Drug Administration are also worded according to the DSM terminology.
The provision of standardized definitions which are embraced by both the research and clinical communities have served to facilitate the dissemination of research results into clinical practice.
Another unique feature of DSM-IV is the extensive evidence-based process that underlies its development. The DSM-IV revision process was conducted over a seven-year period and involved the direct participation of over 1,000 clinicians, researchers and administrators, as well as consultations from 40 different professional and scientific organizations. All changes in DSM-IV were empirically determined as a result of a comprehensive review of the published literature and available unpublished data sets. Many of the proposed changes were then tested on over 7,000 patients in field trials which were sponsored by the National Institute for Mental Health, the National Institute for Alcoholism and Alcohol Abuse and the National Institute for Drug Abuse. The empirical review and decision-making process are documented in a four-volume, DSM-IV source book.
The DSM-IV classification is completely code compatible with ICD-9-CM. In fact, here is an example of a little snippet of the DSM-IV classification for anxiety disorders and you can see on the left hand side there is a listing of the anxiety disorders with their corresponding ICD-9-CM codes.
Representatives of the American Psychiatric Association have worked closely with representatives of the National Center for Health Statistics and the American Health Information Management Association in order to ensure that the ICD-9-CM system continues to accommodate the needs of mental health professionals. All DSM terminology has been included in the ICD-10-CM, Volume II index and there have been many modifications made to the tabular over the years to provide needed specificity.
With regard to the future, we are strongly in support of adoption of the ICD-10-CM as the official diagnostic system. During the preparation of DSM-IV in the early 1990's, we were very careful to construct the DSM-IV so as to maximize compatibility with the WHO's ICD-10 which had been published in 1992. In fact, there were a number of consultations with representatives from WHO's Division of Mental Health, the group responsible for the mental disorder section of ICD, in order to reduce the potential for incompatibility and to facilitate international data collection regarding psychiatric diagnosis.
Furthermore, to prepare for the proposed introduction of ICD-10-CM in the United States, we have worked closely with NCHS on drafts of the ICD-10-CM to ensure that the terminology is accurate and that it includes all relevant diagnostic concepts. And going back to this again, to give you the illustration, this is the same list of disorders with the ICD-10-CM codes assigned. And the categories here in the DSM are virtually identical to the corresponding concepts in 10-CM.
We are quite confident that the current draft of the ICD-10-CM will fulfill all our data collection and coding requirements regarding psychiatric morbidity. We feel that the planned ICD-10-CM system was designed with sufficient flexibility with regard to unassigned fourth character codes and the potential for adding fifth and sixth character subcodes so as to accommodate any future needs for new psychiatric disorders or for ongoing specificity for current disorders.
With regard to the ongoing maintenance of a classification system, we strongly support the current system and processes. The ICD Coordination and Maintenance Committee has been very effective in its role in correcting identified problems in the ICD classification system and in keeping the classification abreast of current medical developments. Working with the twin constraints of maintaining compatibility with ICD-9 terms and conventions imposed by WHO, and the limited availability of three-digits for having new codes, we feel the committee has done a commendable job balancing the need for clinical specificity against the some time competing goals of clarity and simplicity.
Given the comparative freedom of the ICD-10-CM system, the committee has been especially receptive to our concerns that ICD-10 terminology reflect current clinical usage in psychiatry as embodied in the universally accepted DSM terminology.
The interplay between DSM-IV and ICD-9-CM/ICD-10- CM can be seen as a prototype of a successful partnership between a professional medical organization and those government agencies responsible for health data collection and reporting. Similarly, the American Medical Association's CPT coding system is an analogously successful interaction between private and public sector needs and concerns. The CPT development and updating process also integrates input from an array of sources resulting in a useful and highly utilized system.
In summery, given the convergence of the DSM-IV and the ICD-10-CM, we see no rationale for the development of an alternative system for classification. The ICD-10-CM system contains all relevant diagnostic terms that might appear in a medical record, electronic or otherwise, and mechanisms are currently in place to ensure that the ICD- 10-CM continues to mirror current and future clinical usage.
In closing, I will be pleased to respond to any questions.
MS. COLTIN: I think we will hold questions until both presenters have finished. Okay, Dr. Cross.
Dr. James Cross, United HealthCare and AAHP
DR. CROSS: Good morning. My name is Dr. Jim Cross. I am vice president and national medical director for Customer Services Administration, a United HealthCare Corporation.
United HealthCare is a national leader in health care management servicing purchasers, consumers, managers and providers of health care since 1974. The company provides a broad continuum of health care programs and services including health maintenance organizations, point of service, preferred provider organizations and managed indemnity programs, as well as managed mental health and substance abuse services, utilization management, workers compensation and disability management services, specialized provider networks, third-party administration services and employee assistance services, Medicare and managed care programs for the aged, managed Medicaid services, health care evaluation services, information systems and administrative services.
We currently provide health care services for 40 million members. Of these, 14 million are enrolled in our core health products. Over 75,000 employers offer our products to their employees. Our networks include 3,000 hospitals, 50,000 pharmacies and 265,000 health care providers.
In my position at United I am responsible for overall claim medical management, including abuse and fraud, provider reimbursement standards and policies and related systems development. I have been involved in reviewing clinical coding and classification issues with United HealthCare for more than eight years and I participated in the ICD-10-PCS advisory panel.
This summary of coding and classification issues is also presented on behalf of the American Association of Health Plans. AAHP represents over 1,000 HMOs, PPOs and similar plans that provide health care for more than 140 million Americans nationwide.
AAHP applauds the administrative simplification requirement of the Health Insurance Portability and Accountability Act of 1996 and believes that a migration toward uniform standards of electronic business and health care transactions would be an efficient and effective way for transmitting financial and administrative data. We do, however, have some concerns with these requirements, primarily related to the proposed implementation date of the year 2000.
Our concerns stem from the tremendous resource commitment that will be required from a systems, training and documentation standpoint for our third-party payers, health care software developers, as well as providers in order to transition to a different coding system. We also feel strongly that a national standard crosswalk must be developed well in advance of any implementation. These concerns are addressed more fully in our response to the questions.
The first question regarding medical codes and classifications for administrative transactions and what do we perceive as the strengths and weaknesses, we currently use ICD-9, CPT-4, HCPCs, revenue codes, DSM-IV, NUC pharmacy codes, as well as DRGs(?) and administrative transactions. And we also use the ASA's units for anesthesia.
The primary strength of these systems is that they are well accepted as the industry standard for claims administration and submission, as well as for reimbursement. The main weakness is the lack of specificity of many of the coding formats. Although the more generic, less detailed methods of coding may increase coding compliance by many physician's offices, they offer a poorer clinical picture of the patient as well as less accurate physician profiling results.
Coding compliances increases when reimbursement is directly linked to the coding used. For encounter claims where a provider is reimbursed at a capitated rate regardless of the services performed, there is little incentive to submit claims, no matter how simple the coding format. In a fee-for-service situation where the provider is reimbursed for each service performed there is an incentive to accurately code for each procedure. However, in most cases reimbursement is still not tied directly to the diagnosis thus a more generic, less clinically correct diagnosis code may be selected. In a facility setting where coding is critical to reimbursement, compliance is much higher.
Determining enrollment in the managed care environment is relatively easy since subscribers, as well as covered dependents, are individually enrolled. The indemnity environment uses a more passive approach in that a member is not counted unless a claim has been received. Additionally, a member may be entered more than once if claims are submitted using different versions of the same name. For example, Hank, Henry, Hank, Jr., may end up as three individuals in the system when, in fact, it is the same one and because it is not positively enrolled as in a managed care environment, you do not know exactly who the member is.
Under question 2, what medical codes and classifications do we recommend and what specific suggestions would we like to see implemented regarding coding and classification, although we support the migration to a more uniform standard, we feel this must be accomplished through a phased-in approach. There are major system implications with changing to any new coding format. For example, data bases will need to be redesigned. Claim payment edits and software will need revisions and electronic claim interphases will need modifications just to name a few.
These changes are not unique to third-party payers. Health care software vendors and provider billing systems will also require changes and enhancements to accommodate the new coding structure. In addition there will be complex training and documentation needs for all involved.
An additional concern is the timing of the proposed changes. Significant resources and expense have already been dedicated to making the necessary changes to move our systems into the year 2000. We have 80 million lines of code that will take the resources of approximately 200 people and $150 million to prepare for the year 2000. The added burden of simultaneous major coding changes may be more than most can realistically accommodate.
We also feel it will be necessary to have a national crosswalk from the current systems to ICD-10. Without a standard crosswalk using historical claim data would be virtually impossible. Additionally, a crosswalk would be required in order to handle the conversion of claims currently in process to the new coding format. Without a national standard crosswalk we would be encouraging the creation of multiple crosswalks, thus increasing inconsistency, defeating one of the main purposes of the original proposal.
Question number 3 has to do with ICD-10 and its use. Again, we are in favor of moving to ICD-10 but we feel an implementation date of the year 2000 is unrealistic and we believe that there needs to be a crosswalk and a phased- in approach.
Recognizing the goals of PL 104-191, as administrative simplification, how would we deal with the current coding environment to improve the situation, reduce administrative burden but also maintain or obtain medically meaningful information? We need to establish incentives for accurate coding as well as claim submission for encounters. Additionally, we need to consistently capture services rendered to our members by other agencies, such as public health.
How should the ongoing maintenance of medical/clinical code sets and the responsibility, intellectual input and funding for maintenance of these be addressed, and the issue of whether it should be public or private. We feel ongoing maintenance should be handled at a national level in the public domain. This would encourage uniform standards for coding with easy access to all. Currently the private competition fosters multiple standards resulting in higher costs due to marketing and redundant efforts. Multiple standards also cause coding fragmentation, misinterpretation and decreased reliability of data as well as being administratively difficult to operationalize.
What would be the resource implications of changing from the current classification systems that we are currently using in administration transactions to other systems? As previously stated, there are major system implications with changing to any new coding format. For example, one difference is that ICD-9 is a five-digit coding scheme. ICD-10-PCS is a seven-digit coding scheme. Data bases will need to be redesigned. Claims payment edits and software will need revisions and electronic claim interfaces will need modifications just to name a few.
These changes are not unique to third-party payers. Providers will also need their changes in their billing systems. Although we recognize the value of a standard coding scheme, the timing of this change, as well as the approach to implementation, is of great concern.
A coding and classification implementation team has been established within the Department of Health and Human Services. Does our organization have any concerns about the process being undertaken by the Department to carry out the requirements of the law? There is concern that we find a balance between the academic needs for data collection and what we are reasonably able to process and store. More data is not necessarily better data. We need to be prudent in determining requirements that meet but do not exceed our current and future needs.
The AAHP endorses the Subcommittee's charter and invites further discussion on any area of concern, and I welcome any questions. Thanks for this opportunity.
MS. COLTIN: Thank you. Okay, does anyone have questions for the panelists? Lisa?
DR. IEZZONI: Dr. First, thank you for your excellent presentation. I am a little bit confused, though, about DSM-IV and its relationship to ICD-9-CM and to ICD-10- CM. Dr. Cross just indicated that United HealthCare uses ICD-9-CM as well as DSM-IV, but you said that ICD-9-CM and DSM-IV codes crosswalk on a one-to-one basis.
We heard yesterday, in our testimony in the afternoon, one of the respondents say that DSM-IV was better for coding mental disorders than ICD-9-CM but, again, I am confused. Can you help kind of shed some light on what is the source of this confusion and --
DR. FIRST: The confusion is quite understandable. The mental health community, because of the advances that I mentioned in my presentation about having criteria in particular, having exact definitions that mental health practitioners can understand and apply as a system, like, for instance, the concept of major depressive disorder is a concept in the system that has specific definitions, and mental health professionals, before they assign that diagnosis on a case they have seen, make sure that the patient or client that they are seeing has a presentation that meets the criteria. So they go open up the DSM and they would assign that term, major depressive disorder.
In order to meet the requirements that clinicians use the ICD-9-CM coding system, we have taken, essentially crosswalked the ICD-9-CM and those codes are the codes that actually appear in the DSM. So what happens is a practitioner using the DSM-IV is, in essence, meeting the requirement that they are using valid ICD-9-CM codes.
The difference is the fact that if you open up the ICD-9-CM tabular the terms are very different. Part of the problem is that those terms are based upon the ICD-9 which was developed in the early 1970's and the first, you know, the DSM has been revised a number of times since then and the terms in the DSM reflect current clinical usage whereas a lot of the terms in the ICD-9-CM are actually fairly anachronistic. So most mental health professionals, if they would actually look at Chapter 5 in 9-CM they would be very mystified about what anything means.
So the DSM sort of connects to the clinical usage but the crosswalk allows the proper, the most appropriate ICD-9-CM codes to actually be applied. So there are two independent systems, but we have worked from the beginning to maintain compatibility so that the proper codes are used. DR. CROSS: And that is why administratively we can handle it and we use the DSM-IV or the ICD-9 in administration because there is the crosswalk that exists. And the clinicians today use DSM-IV so when we work with our providers or write contracts or do clinical interaction with the physicians, it is using DSM-IV terminology. In billing they can use DSM-IV or ICD-9-CM. Because there is a crosswalk, it comes out the same in the data collection.
DR. IEZZONI: Can I just follow-up? One of the attractions, I understood, starting with DSM-III, was a multi-axial system of reporting on patient's presentation. You are not talking about having all the axes within DSM also represented in ICD-9-CM are you?
DR. FIRST: You know, we have never, part of it, again, is that we have seen the multi-axis system as being incredibly useful for clinicians and we see the interface with ICD as a way of taking the information in the DSM-IV and allowing it to be integrated in the data bases that are ICD-9-CM and then ICD-10-CM based. So there has not been, so we have developed a multi-axial system, you know, with as much freedom as possible to make it as useful as possible and not, it is so different than ICD that we have never really attempted -- we are actually looking ahead in ICD-10- CM there has been a major expansion in the Z-code section which includes problems that might impact on the patient. And that actually is very close to our axis-4. So we have actually kept an eye on the Z-code section to make sure that, so ultimately there is the potential to have axis-4 in ICD-10-CM.
The only other axis which is different is axis-5 which is a 100-point scale for functioning. It is hard to imagine how exactly that would fit into 10-CM.
DR. IEZZONI: Because, you know, I think one of the concerns of the committee is that the paradigm under which we are kind of discussing this is billing, you know, to be honest. But we want to move forward and begin to get more clinical so we can use the information for quality assurance purposes and so on and so, you know, I think that it might be something that the committee might be willing to think about, the full kind of complement of axes and coding -- maybe not the functional level because I agree with you that there might be some reliability issues there -- but think about the DSM-IV for its full complement of axes and coding to move us towards a more clinical use of codes. Is that something that the APA has thought about?
DR. FIRST: Well, we would certainly be in favor of --
DR. IEZZONI: Right, I assumed you would.
DR. FIRST: -- the multi-axial type approach being taken because we feel very strongly that it has been incredibly useful for clinicians and I do not believe it is confined to mental health.
The concept that problems impact on the delivery of health care that are not medical problems is something that is, you know, concerns all of medicine. So that approach, I think, the Z-code section of ICD is moving in that direction. I think it could probably, with not a lot of effort, be expanded and made more of an orthogonal axis that could be, you know, emphasizing the two different aspects.
DR. IEZZONI: Thank you.
MS. COLTIN: Kathleen?
MS. FRAWLEY: Dr. First, I just, yesterday afternoon we heard from representatives of the medical speciality groups about the difficulties they have been having in terms of billing, with third-party payers not adhering, you know, to official coding guidelines and coding conventions. And I was just wondering on behalf of your specialists, have there been concerns in terms of that particular issue?
DR. FIRST: In terms of the third-party payers not accepting the diagnostic codes, per se?
MS. FRAWLEY: Right.
DR. FIRST: I think that our experience has been that a lot of the third-party payers have been willing and open to use the DSM partly because the entire mental health community has been using it so it has become in some way, I think, the classification is more part of the practice of the mental health professional then I think, so there is more focus on that. And my sense is that there has not been that much of a significant problem.
Dr. Pincus has a [unintelligible] see if he has any other experience with this.
MS. COLTIN: Could you come to the microphone?
DR. PINCUS: As Michael said, there is fairly universal acceptance of DSM-IV as the system for defining various mental disorders. Sometimes some payers will exclude certain categories of disorder, either because of contractual reasons or because, often for arbitrary and capricious reasons --
[Laughter.]
MS. COLTIN: Thank you. Jim?
MR. SCANLON: Dr. First, does the DSM include the substance abuse treatment area and addictive disorders area as well so it completely covers that?
DR. FIRST: Yes, absolutely. We have always considered that to be part of our purview.
MR. SCANLON: And you mentioned a little bit about the maintenance and updating of the DSM before. Could you say a little bit more, is there a process in which APA basically has an editorial board or some other process whereby you consider codes, you consider additions, and what is that exactly and how does it relate to the ICD-CM(?) maintenance?
DR. FIRST: That is a good question. There are kind of two parallel processes. There is the process of actually revising the DSM system itself and then there is the process of making sure that we stay up with the coding system. So there is almost like two interfaces.
The process of revising the system actually happens in fixed intervals. Our experience is that once, any changes that are made in the system are so disruptive that we have made the decision that rather than every couple of years changing the criteria or adding a new disorder or deleting, that that would be so disruptive that we take intervals of seven to fifteen years, in the past, to actually make, look at the whole system and make sure the entire system is updated as a whole.
So when errors are pointed out to us, like in the text, we have, you know, fixed that, but we have resisted the temptation to every year go through and tinker with it, make it a little bit better because of the, we think from a cost benefit analysis the disruption. We do feel very strongly that periodically that has to be done.
Now, on the other hand, with respect to ICD-9-CM and ICD-10-CM, I have been the APA's liaison with, and sort of in charge of keeping an eye on the coding system and we have, as, we have done in incremental steps is to try to make proposals to try to get more specificity codes assigned or codes changed to keep the ICD system as close to the DSM system as possible. In theory once, we see this as a very important opportunity now with the putting together of ICD- 10-CM. We have been working very, very hard to make sure that the system that comes out is as code friendly and compatible and contains as much specificity with the DSM system as possible.
So we imagine that in the next number of years that the need to ask for newer codes we hope we will not need because if the system is done well in the beginning there may not be a need for new codes until we actually undergo our next revision which is going to be, you know, certainly more than eight or ten years away.
MS. COLTIN: Lisa?
DR. IEZZONI: George, I think had --
MS. COLTIN: Okay, George?
MR. VAN AMBURG: A number of panelists yesterday indicated that a transition to ICD-10 would be good and you have indicated that today, but no one has given us a reasonable time line that they think would be workable. Can you give us an idea of what you think would be a reasonable time line?
DR. CROSS: Well, as I said, I think the year 2000 has really got most of us pretty busy. I think the ICD-10 change is not just an update of ICD-9. I mean, it is a new system and a new methodology that sort of has to be learned. And I think it is an appropriate methodology.
Our experience with, just changing evaluation and management codes within CPT-4 was a significant change that sort of happened, boom, within a few months, was published and then providers and all the rest of us sort of had to scramble to adjust to those evaluation management codes. And I would say that even today not everybody fully understands those codes or is really comfortable with using them.
So, I am not sure that we really did a good job or as good a job as we all could have to education providers and educate ourselves and get used to the new system that was [noise interference] to use with a new coding methodology. So, I would say it has to be, you know, a five-year or so time frame as opposed to two, and I think there has to be a significant amount of effort of communication and training and trying some of this new methodology before we, you know, either legislate it or require it or whatever.
And I think, again, if we switch to it we have to have some semblance of tracking back to the previous data. Otherwise we lose all the historical information that is attached with that particular patient. So, my personal time frame would be no sooner than five years.
I think there is some confusion, too, between a coding system that is a data collection system or an information sharing system which can be very detailed and very specific and very individual in its coding versus a reimbursement methodology which has a tendency to follow CPT-4 kind of logic of global administration.
So, I think where a fair amount of conflict or disagreement or confusion lay, lies, lays, is in the desire to have accurate coding and specificity versus what an individual insurer or a health plan or a benefit design would say reimbursement needs to be based on.
So there is a fair amount of effort to bundle codes back together, substitute codes that we think might be inappropriate and there is a more appropriate code that would describe what it is that really happened. So it is not so much that people, I think, in general, do not want accurate data or information, I think that data collection and information gets mixed up in the reimbursement methodologies. And one of the things that we all struggle with is that there is no standard reimbursement methodology out there. It is a piecemeal process. You take ICD-9 for facility and for professional claims for diagnosis. You take ICD-9 for facility procedures for facilities to submit and revenue codes. And you take CPT-4 for physicians to describe what procedures they are doing. Anesthesiologists have unit times for things that they do for procedures whereas CPT-4 has already got procedure codes that describe those procedures.
We have revenue codes that describe the facility portion of a physician's visit but the RBRBS system and the CPT-4 coding systems says that a physician's evaluation and management code is an entire global code so the two do not match and there is no way to split the global code from the physician with the facility code that the other system splits out.
So, every time there is some gray area or discrepancy or conflict amongst the various coding systems it does not mean that the coding systems themselves are necessarily bad per se. It is that nobody has taken the time or the effort, or each individual insurer or health plan does take the time and effort to try to put it together and crosswalk it and make sense out of it so that they can globally administer their reimbursement policies. So, many times physician's frustrations are based on reimbursement policy. They are not based on codes, per se, or administrating data.
And a lot of the data is based on billing today. It is not based on clinical data. It is very difficult to get at the clinical data based on a bill. I mean, we have now data, for example, that somebody died. They do not submit a claim. There is no code. So, if you want an outcome result, you do not know whether they died or not. I mean, it sounds stupid but when we were doing transplant outcomes we had to literally call people up to find out whether the patient died or not.
When we were doing immunization studies the CPT information in the claims system was not as accurate as it needed to be. It ran about, I do not know, anywhere from 70 to 90 percent. We literally had to go to physicians' offices and do chart review to get the information to do the HEDIS kind of reporting to say this is what really happened in the immunization experience of that particular provider of that population group.
There was a question yesterday about global OB. Well, from a billing point of view and CPT-4 logic point of view, it is a global approach. From a data collection point of view, you want to know about every visit and the post partum visit and all the rest. Well, we just blew all those codes away. We told them to bill globally because that is what the reimbursement is driving.
None of us would necessarily mind getting the data or keeping the data, but so much of what this coding methodology is all about in terms of providing the data or dealing with the data has to do with reimbursement. So, I think one of our challenges is to divide the two, separate them. Talk about data collection and information sharing and leave the reimbursement methodologies to another system. But, then work on trying to make a common, relatively standard, reimbursement methodology that everybody can look to. We sort of look to Medicare, but, you know, all the answers are not with Medicare's methodology either.
MS. COLTIN: Dr. Cross, to follow-up on that, you talked about the fact that under capitation you may have problems with submission of encounter data as well as the accuracy of the coding on those encounters. You said that we need to establish incentives for accurate coding. When you say that and you say, we, do you mean your organization, the industry, do you see a role for government in that or other --
DR. CROSS: I think we left it fairly broad because it is probably all of those things. I mean, when we do contracts [noise interference] we usually have to put some kind of incentive or some kind of expectation on our part that they submit that data for them to remain in the network and for them to be contracted and to be under a capitated environment.
It is very difficult, actually, for physicians to manage themselves in a capitated environment if, in fact, they do not have information at the level of at least claim information. So encounter information, for today, it essentially translates to a claim, whether it is paid or not paid or reimbursed or not reimbursed. That amount of data is sort of the bare minimum for a practice to manage itself and for us to get information to even share with physicians so that they can manage that capitated rate. I mean, if they do not know what they are doing and they just assume that they are doing it right, three years down the line is when reality hits.
So, we can bargain all day on a capitated rate, but if we do not have information, either one or us in a partnership, then we do not know what we are doing and then the risk gets too high and then that is when things fail. So the data is crucial, both to the physicians or hospitals or whoever it is that is trying to manage the care in a capitated environment and it is critical to us to know what they are doing both from a quality point of view and from an information management point of view.
And then I think it has to be shared. But our experience in that, when it is not related to reimbursement, is somewhere in the 60, 70 percent range. When it is related to reimbursement, it is pretty accurate. I mean, it is up in the 99.8 percent range. Most people do not forget to send us information when it is reimbursable.
[Laughter.]
In fact, they usually send it more than once.
[Laughter.]
MS. COLTIN: Others? Jim?
MR. SCANLON: Could I just follow up? Following up specifically, I assume that the hospital care, such information about hospital care is probably a higher percentage and that ambulatory care is probably 60 or lower.
DR. CROSS: Well, it depends on what you want to know about hospital care. You know, UB92s have roughly five dump categories of things to bill and radiology services is, all radiology services are under that code. Lab is, all the lab service is under that code. Room and board is under that code. I mean, if you want to know what happened in an episode of care in a hospital, the electronic information is worthless. You have to ask for the paper, 20-page, detailed bill to know what drugs they gave, what services they performed, how many days they were in the various levels of the hospital and so on.
So, information off the UB92 is, you know, fairly accurate in the sense that it categorizes it correctly. And the diagnosis is fairly correct because it drives a fair amount of reimbursement and some per diems and some DRGs and all the rest. So the diagnosis, I would say, on the facility side is pretty accurate.
When we do DRG review or when we review what codes are submitted for diagnosis, ICD-9s, and look at actual charts it is way less than 2 percent of the time that we have conflict with what the diagnosis is. And because the facility is an environment where a diagnosis is more or less made or confirmed or further along, so to speak, than it is in a physician's office, we get less of a situation where they are more generic, where they are more rule-out or they are more broad in their description. So, a physician's office, I would say, tends to have more broad diagnoses and a facility has the tendency to have more specific diagnoses. The facility information, though, is, to really know what is going on and to manage it and no complications and all the rest, you would not only have to have the detailed bill, you would actually have to start having some clinical records. Right now we have essentially no information from a clinical perspective submitted to us other than if on the bill we cannot figure out what is going on or if it is a 99 CPT-4. If it ends in 99 it is unlisted or something. That is when we end up having to ask for records.
We ask for records probably 7 percent of the time. We pay 300,000 claims a day. So, when we have to manually look at records and have operative reports sent in or emergency room records sent in or narratives sent in then we have to either handle them by paper or scan them and electronically transmit them, but we need more information than what is on the claim to decide what the code means or whether it is appropriate or reimbursable.
So, you know, everybody is in favor, I think, of clinical records and that they should be electronic and so on, but we are in our infancy about dealing with clinical electronic records.
MR. SCANLON: Just a follow-up, so for the purposes of a United HealthCare-like organization, for various purposes of management, utilization review, resource utilization and performance measures, you are more or less dependent less on the claims and pseudo claims data then you are on the actual records or the detailed hospital care and ambulatory care?
DR. CROSS: I am not sure that I got your question correctly because I think we are definitely dependent on claim data. That is the source of our information. In fact, we spend, you know, we spend $10 million a year on various software tools to take the claim data and start to use it for quality, HEDIS reporting, profiling, episode logic, all the things we have to use in back-end data bases that we have to then have software that sort of, either through artificial intelligence or smart software to put the thing back together in a clinical perspective. That is when I had mentioned about software development, is all of that logic that has been built off ICD-9 and CPT-4 coding would have to be rebuilt to be able to deal with all of our quality tools, all of our episode logic, all of our HEDIS reporting. Everything is based on the current coding system. So, all those software vendors have to go back and recreate this logic to be able to put episodes together for us to do profiling.
But it is, the most information we have is from the claim unless we physically go out and get it. And if we want customer reaction or member reaction from a quality point of view then that is another survey or another telephone call or another way to add that kind of feedback into the quality equation. All of that is very resource intensive and, you know, so one of the problems with NCQA and HEDIS and all the rest is the continuing burden to do more and more and more when our environment is that it is not electronic, it is not easy available and it requires a fair amount of resource to get it.
And I do not think anybody is opposed to getting it. It is just a matter of how do we get it, how much do we get, how much do we need, where are we going to focus and how do we get the provider community, the facilities, up to speed electronically and then how do we get up to speed to deal with it?
DR. IEZZONI: Actually, that was the exact question that I wanted to ask you because I heard you say that when you wanted to do the immunization study for HEDIS you had to go out to doctors' offices and comb through records to find out whether they had immunized children.
DR. CROSS: If we wanted to look good in the newspaper, yes.
DR. IEZZONI: But I would suggest that that is another business need that you have now --
DR. CROSS: I am sorry?
DR. IEZZONI: It is another business need that you have now to be able to respond to HEDIS --
DR. CROSS: Oh, clearly.
DR. IEZZONI: -- and so, you know, even though the context in which the data have arrived to you, that you have used prior for HEDIS was billing, now there is an independent business need to have HEDIS-type of information that, you know, to be able to report to get customers.
DR. CROSS: Yes, I think definitely the business need is there, the desire to have quality improvement in medical care and to have the information to share with providers to improve that situation, I mean, I think that definitely the demand and the needs are there. All I am saying is the resources to do that are significant and --
DR. IEZZONI: Well, I wondered if you could put a figure on it for us, on when you went into the field and did the immunization study. Can you give us a sense of how much that cost?
DR. CROSS: Well, typically we would have to hire an extra two people per plan site just to do HEDIS reporting.
DR. IEZZONI: Oh, and how many plan sites?
DR. CROSS: We have 44 major plans in the country.
DR. IEZZONI: Adds up.
DR. CROSS: And that is not speaking anything of the software development or the systems development to get the data. We have a whole team of people that just work on HEDIS reporting. I think there are a dozen people that just have to do HEDIS reports. And then all the time that it takes for the medical directors and the health service directors to look at the data and look at the information, milk it, you know, review it, get it up to snuff and then have it available for us to publish and share with customers and with plans is a fairly significant job.
And I am not saying that we should not do it or that we do not need to do it. We are doing it. Most plans are doing it. You have to do it to be in the marketplace. You have to be NCQA sensitive to be in the marketplace but it is not easy to keep dealing with all of this data, these data requirements, let alone to store the data, historically to store the data. You are talking about storage space that is extremely expensive and it gets more and more expensive as we require more and more history.
We do not share history either across plans or providers or insurers. I mean, you could be with us for one year and you could be with U.S. HealthCare Etna the next year and you could be with somebody else the following year. So, if you want to know about that patient and what their disease management environment is, we have no way to, we have enough trouble sharing eligibility data, just the individual's name and Social Security number, to share that across systems is not a pretty sight sometimes. So, to actually take the data that is the history of that patient, just the claim data, we do not share that with each other at all.
So when you want to take a snapshot of what a patient, what is going on with a patient, I mean, we have the software and the ability to put an episode of care together and we have the ability to go through history and put that together but only as long as they have been with us.
MS. COLTIN: I would like to follow-up on that, too. I think that the report that NCQA just issued around the future of performance measurement raises a number of issues that could fairly dramatically change the picture in terms of whether it is 7 percent of charts that need to be reviewed or whether it is --
DR. CROSS: 70 percent.
MS. COLTIN: -- 70 percent. There are measures being looked at that rely on laboratory result information, all of abnormal tests --
DR. CROSS: Which we do not have.
MS. COLTIN: -- that sort of thing. What do you see as the implications of those kinds of requirements for the data collection stream?
DR. CROSS: Well, currently, we cannot, we on the back end of the data base can put hospital information, physician information -- professional information -- pharmacy information, surveys and put that all in the data base and then pull it out and do reporting. We have no ability to take a clinical record and put it in that data base so we have no way of putting values, lab values. We would know what test was done but we would not know what a value was of the test.
We would know that they did a CAT scan. We would not know the result. We would know they did an LDH liver test but we would not know the result. We would know that they did a genetic lab test but we would not know the result. So, I think that it is crucial that we have the clinical record and we have certain data elements out of that clinical record and that it be coded so that we can transmit it electronically. We need to get there.
I think the requirement to have this kind of information prior to developing some more easily administrative process is an absolute nightmare. You are talking about going back into the, you know, into sort of the dark ages of having to do chart review or record review on essentially every single case.
I mean, we barely do that on hospital cases. We do not go to a hospital and look at every single chart. We might pick some out. We might do certain ones. Or in certain plan sites, if it is a huge hospital and we have a great relationship, you might have a nurse there that does all the charts. But as a general rule, we do not review every chart even in the hospital, let alone reviewing every single chart in a physician's office, if they would let us in.
MS. COLTIN: That is even if you can identify the right charts to review because when you have a measure like follow-up of abnormal tests, if the abnormal rate is in the 5 to 10 percent range you have to review, you know, ten charts for every one where you do not find a normal for the measure.
DR. CROSS: Yes, there is a tremendous need to have a clinical electronic record and I think it is a huge project. I think it has a lot of potential positive things that we can do for improving health care. We are just not there yet. And to require clinical information from a payer or a health plan beyond what is either feasible or focused or whatever, you will bury the industry. We just will not be able to afford it and then ultimately our employers will not be able to afford it and ultimately the patients will not be able to afford it.
MS. COLTIN: Are there other questions? Lisa?
DR. IEZZONI: Jim, was your question on this --
MR. SCANLON: No, this was a separate --
DR. IEZZONI: I actually had a question for Dr. First. You indicated that the APA participates actively with NCHS on updating the ICD-9-CM and ICD-10-CM on diagnostic nomenclature and that you participate with the CPT activities at the AMA. I just wondered whether the APA has also worked with HCFA on their procedure classification that is currently under development? And, if so, what you think of it.
DR. FIRST: Well, actually, probably Jim Cross will have had more involvement with that than any of us. I mean, there has been very limited participation with that group --
[Simultaneous comments.]
PARTICIPANT: We have a specific work group that is, I think you are talking about the 3M program?
DR. IEZZONI: The 3M project, yes.
PARTICIPANT: Just some preliminary involvement with it. I do not think we have come down to any conclusion either way. I think they have identified some problems with the study but I do not have specifically, unless I have given that to you, Michael Harold(?), the specific concerns. I think that there is some question about vagueness about the whole process in terms of identifying codes and procedures. There are some difficulties with that and I do not know what the rest of medicine thinks about it but our involvement has been ongoing but I do not think it has moved very far.
DR. PINCUS: It is also, I mean, there is a qualitative difference between our level of involvement with the 3M effort and the ongoing involvement with CPT. There was one point that actually I wanted to make about the issue of implementation, or raise two points. One is, at least with regard to diagnosis, ICD-10-CM is vastly superior to ICD-9-CM so I think there is an important imperative with that regard.
Number 2 is, whatever the actual implementation date is, that having the final version of ICD-10-CM as early as possible so that it is clear that this is the way it is and here is how to, and whatever the time is to implement it so that we know as early as possible with clarity the way it will appear, it will be extremely helpful.
DR. CROSS: One caution about ICD-10 is that, you know, it is a new system but you have to go all the way to the seventh digit to make the diagnosis decision. You cannot, there is very little of the ICD-9 bucket type of coding. So, where you could just use three digits and it would all go through the system and everything would work, you cannot do(?) that anymore. I mean, you really literally have to go through the various body systems and all the rest and classifications and get to that seventh digit to say what it is that it is. And unless you use that seventh digit --
[Background conversations.]
DR. CROSS: Procedure, I am talking about procedure, I am sorry. You were talking about diagnosis. I was talking about procedure, I am sorry.
DR. PINCUS: Yes, the diagnosis one it is a, I mean, in principle it is quite similar to the ICD-9-CM. It is just much, much better.
DR. IEZZONI: But I would like to hear Dr. Cross's opinion of this.
[Simultaneous comments.]
DR. IEZZONI: -- finish your comment.
DR. CROSS: Well, just that, you know, the reason I mentioned training and education and putting it out in front and getting used to it and everybody working with it a bit is because, I mean, everybody who uses procedure coding today will have to learn a new way to do it and think of it in different terminology. And, in fact, some of the terminology is not the usual terminology that we would commonly use. It is requiring us to do a more scientific way of looking at the terminology.
And the practical part of it that I was trying to get to is that currently if you do not really know down to the seventh digit or you do not really know what it all is you can use three digits in an ICD-9 procedure code or use five codes(?) of a CPT-4 code for a procedure and be, you know, basically in the ball park.
And these codes, you would have to go the seventh digit. It does not work unless you use the seventh digit. Our systems do not even have room for seven digits. We only have room for five because five is what codes that are out there now have. We would have to rebuild all those systems and all the logic to use those other two digits.
I mean that is not, sounds simple but it is a big deal. So, it is going to take time to put this stuff in. Nobody is arguing, well, I do not think people are really arguing that we need a more detailed, more scientific, more logical approach to procedure coding, but we just have to figure out a way to get there and I think again the crosswalk is going to be key. And it is going to be difficult because there are different methodologies so the crosswalk even will not be simple.
DR. PINCUS: Another thing on the diagnosis side, I mean, it is a totally different picture because it is much less complicated doing the transition on the diagnosis side.
DR. CROSS: Right, I agree.
MS. COLTIN: Simon?
DR. COHN: Yes, I guess I would have a question for all of you and first of all, Dr. Cross, thank you very much. I have really appreciated you, I think, reminding us of all the problems that we really do deal with around data, especially in the capitated and managed care environment. You need more but the incentives to create it are obviously vastly different.
I am actually struck and I was wondering the view of the panelists, that one gets a sense that the ICD-10 diagnosis is something that we should be implementing sooner rather than later and yet I think we all have a certain amount of concern around procedure issues just because it is obviously a much, seems to be a much different task. And yet I have tended to think intellectually that if we are going to go to the trouble to implement one we ought to implement both. What are your views on that? Should these be separate implementation processes, separate time lines?
DR. FIRST: We do not, in fact, I think you are making a good case for separate time lines. We see that, I mean, as far as we are concerned, the APA, we are ready for ICD-10-SAM(?) now. We have done a lot of --
DR. COHN: Diagnostic?
DR. FIRST: Yes, the diagnosis, sorry, I keep, I mean the diagnoses system. We, I mean, if it were implemented tomorrow it would be -- obviously we know that that is not going to happen -- but we would be ready for it and we would be thrilled because we see it is such a major improvement over 9-CM and we think the transition to it -- see, part of it is we from, when we were working on the last revision of the DSM we were looking ahead to 10 so we have sort of been ready for five years in a sense.
So, we are probably more ready than most other medical organizations. But we see the, even if we had not done all that preparation, we see the jump from 9 to 10-CM on the classification side as being a much, you know, just the next logical shift and better specificity. And really it is bringing the system up to what is currently being clinically used. I think the clinical community will find 10-CM more comfortable to work with because it reflects current thinking.
Now the procedure code system sounds like a much more radical, it is a bigger difference and I can see that inherently it might require more preparation and we are not, I guess we do not see why they absolutely have to be linked together.
DR. CROSS: Historically the diagnosis system has been the same so when facilities are billing us or whether physicians are billing us they are all using ICD-9. So where you move from ICD-9 to ICD-10 I do not think that that, I would agree that that is not as big a jump. When you have facilities using revenue codes and physicians using CPT-4 and there is HCPC(?) coding out there that describes some things, once you get to the procedures, supplies, DME, home health care, all those kinds of things that we need codes for to figure out what service is being rendered, as opposed to the diagnosis, then that is when the system, I think, has multiple aspects and multiple ways of coding. So that is the one that has to have more work.
DR. COHN: Okay, can I ask one follow-up question? MS. COLTIN: Yes.
DR. COHN: Yes, just to make sure that I understand, Dr. Cross, you were saying, actually, I think, preaching a wait or at least a very cautious motion or integration towards procedure. Would you be more comfortable then with an earlier migration to ICD-10 diagnosis?
DR. CROSS: Other than the year 2000 issue, I mean, that is a significant issue. That takes up a sixth of all of our IS resources. One-sixth of our IS resources are tied up in the year 2000. So, if you want to change the coding system of anything between now and 2000, to get it on the que and to start working on it and to find the resources and the money, it is just not going to be there.
So, if you want to work on a new coding system that we can handle, short of a crosswalk, you could get providers to start using ICD-10. You could get people to start getting familiar with it but we would have to translate it probably in the system beyond the year 2000 and then start to make the system changes and all the software changes and all the vendor companies would have to be working on all their software changes to deal with that new ICD-10 coding system. And they are just as busy as we are with the year 2000 fixes.
So, you know, it is really kind of bad timing even though you would really like to use some of this new coding pretty soon. You know, we are, many, most of us have old main frames out there and they all just have to be fixed and you have to go through every line of code and fix the stupid thing.
DR. COHN: At least that is one problem [unintelligible] really(?) quick(?).
DR. CROSS: That is right, that is right.
[Laughter.]
MR. SCANLON: If we can follow that up, Dr. Cross. Is there a perverse logic here that while you are looking at those 80 million codes, lines of code, at any rate, to fix the date problem that it would be very positive to have the standards at least identified so that at least a thought could be given to what the structures of the files might look like? And I am not speaking only here of the classification and the diagnostic systems but of the enrollment and the claims and other kinds of standards as well, to know what the standard would be well in advance even though the implementation date might be --
DR. CROSS: I think the more information you have up-front and you know what it is going to look like the better you can put it into your plan. Clearly when we do other updates in the next couple years we will try to solve part of the year 2000 issue as we look through the various codes of whatever we are updating or whatever we are doing. But literally the machine will come to a halt if we do not find it in every single line. So, it is sort of a different project. You can work on it a little bit but you cannot like finish the project unless you literally go through every line.
We actually are eliminating one of our major systems so we do not have to pay the expense of fixing it for the year 2000. We are moving one-third of our customers onto another system over the next two years so we do not have to change the system. I mean, that is a significant move and expense and customers to deal with and systems to move and benefits to move. I mean, it is a big deal.
MS. COLTIN: Other questions? Yes, Betsy?
MS. HUMPHREY: Yesterday, I wanted to ask Dr. Cross, yesterday we heard from a lot of people who commented on difficulties, I think you could say it was more from the provider side of different specialties where they were commenting about non uniform implementation of the existing coding systems among payers so that maybe the new things were not implemented every year when there were adds or this, that or the other thing. And there seemed to a universal request for there to be nationwide implementation guidelines that would have to be adhered to without so much payer specific variation as part of this whole standards process.
And I got to thinking about this last night in terms of the whole question of ICD-9-CM versus 10-CM and time frames. And I really would like a, I wanted to ask from the payer's perspective is the implementation or, shall we say, the elimination of this variability -- that is, okay, you cannot do this anymore, the standard is, by X, it is the standard -- is setting something up for even the existing standards that are, I mean, de facto standards or the systems that are currently being used, is that equivalent from the payer's point of view to implementing a new system?
I mean, is it just as bad, quote, from their perspective if we were to announce that, okay, we are not moving to ICD-9-CM on this thing. We are cognizant of the year 2000 problem so we are going to set that up in a slightly longer time frame. But, by god, by the year 2000 there will be, everyone will be adhering to the same coding standards and everyone will have to accept all the codes. I mean, is that, is that a major deal for payers?
DR. CROSS: Well, I listened to the physician presentations yesterday and I really think that there is confusion between whether we use the coding systems and what the reimbursement logic is. I frankly do not know of any payer that does not use CPT-4 codes or any payer that does not use ICD-9. I think the issue comes down to interpreting what CPT-4, for example, is saying in terms of what the reimbursement logic should be.
Typically, CPT-4 allows only certain codes to be in it. And once they decide that they have value or that it is the way they want to approach a particular procedure it gets to have a code. And then it gets a description. And then there is in CPT-4 sort of a logic that overlays the whole thing that talks about a global approach to the coding. It traditionally has not had a lot of unbundling of various codes. Its basic philosophy is to not piecemeal things but if it is a procedure you do not bill for going through the skin and then going through the fascia and then going down in and tying off a bleeder and then coming all the way back out. You just bill for the procedure.
Now there are a lot of things that have codes in CPT-4 that when other professionals look at it they appear incidental to the other code. Those codes are built as if they are done alone. If you only do this procedure this is what it is. It includes all this stuff and that is the code. But many of the procedures are done at the same time. So, if you do three things in one setting, all of which are appropriate codes, because it includes the evaluation and management it includes the post operative care, it includes the hospital visits, it includes everything in a global sense, you do not do that three times. You only do that sort of once, but you did three procedures.
So we have unbundling rules and multiple surgery rules and we have rules about assistant surgeons and what the percentage of reimbursement is for an assistant surgeon. I mean, CPT-4 tells you that you should use this modifier if there is an assistant surgeon. It does not tell you what percentage of the doctor's fee he should get.
My point is that everybody uses CPT-4, but there is a tremendous amount of effort and software development and companies out there that make money evaluating all of these codes, all the logic and then devising a system that says this is how we should deal with these codes for a reimbursement methodology. And that is what varies. That varies from health plan to health plan, from payer to payer and if you want to get really complicated each employer's group, if they are self-administered, can decide how they want to have the reimbursement work. And, in fact, some of it is union bargained.
I had a case the other day where the union bargained how to do multiple surgery logic and it is written in the union contract. You come to me and say, United HealthCare, you do not know what you are doing. You are reimbursing my members over here three different ways. It is not because I want to. They union bargained it and I do what the employer pays me to do. Do I like it? No. I have health plans who want reimbursement 44 different ways because there are 44 of them and each of their provider communities demand that the way they are reimbursed has to be that way in their community.
I do not believe most of it. So, from a payer point of view there is a tremendous amount of efficiency, productivity, consistency and frankly, quality of claim payment if things are more standardized. In fact, I would love for it to be more standardized. I would love for all the plans to do it the same. I would love for all employers to agree that this is the reimbursement standard. I would love for everybody to sit down at a table and say, assistant surgeons should get paid at x percent and we are going to do that across the board and we are going to agree when there should be one. I mean, to me that is something that, you know, a government agency or a private government agency, cooperation with providers and with payers and with the government could be a cooperative effort to try to come to some standardization of this process.
Everybody is frustrated with it. The providers do not like it. The members, the patients out there do not like it. They cannot understand it. They get balance billed if it is not a network environment. I mean, everybody hates this but we have to do it. When the claim comes in we have to do something. We have to decide. And there is nobody to look to to say this is the way you should do it. You have to figure it out yourself and you have to try to be as fair as you can.
And there are multiple coding systems out there. I mean, revenue codes are sort of dump codes for certain things. A 99070 is a CPT-4 code for supplies. Well, what does supplies mean? Anything from A to Z. How do you put a fee in there for supplies? We have terrible coding when it comes to durable medical equipment, supplies, devices. I mean, we do not know what it is.
The drug information, none of the drug information is in our system at all. If it is submitted through the pharmacy and goes to the pharmacy computer system and they use NDC codes so that each drug literally has a number and you know what it is, then you can make decisions about it. We are going to pay it, we are going to not pay it, when it is appropriate, not appropriate, were the outcomes right? You know, you can do some good stuff there.
If you send a pharmacy claim to our normal claim paying system, it gets loaded as RX. How do I manage RX? I do not know. I mean, we could go on and on and on but I really think, though, that CPT-4 has a lot of good in it and I think there are things that HCPCS has that has a lot of good in it, but there is a lot of work to improve the coding system, particularly as it comes to procedures and devices and supplies and things like that.
The problem is not, in my mind, on the diagnosis side. The problem is on the other side and revenue codes do not necessarily match with CPT-4 codes and the reimbursement logic of CPT-4 is not in ICD-10-PCS. ICD-10 is going to give you a coding system to say this is what it is. It is not going to give you a coding system that tells you this is how you reimburse or deal with it. Does it go with this one or does that one include the other one? That is CPT-4 logic. You could implement ICD-10-PCS tomorrow and you still would not know how to put all the codes together or how to reimburse for them. So there is another overlay of logic that CPT-4 brings to the table that ICD-10-PCS is not even addressing. I mean, the intention is not to address it.
MS. COLTIN: Okay. We are scheduled to take a break now unless we have any burning questions.
PARTICIPANT: We certainly want to thank the speakers.
[Brief recess.]
MS. COLTIN: Okay, we are going to get started again. Our next panel is representing the public health and research communities. Would you folks introduce yourselves, please.
MR. HAMM: My name is Michael Hamm, executive director of the National Association of Public Health Statistics and Information Systems.
DR. DWYER: I am Dr. Diane Dwyer. I am the Maryland State Epidemiologist and I am representing the Council of State and Territorial Epidemiologists.
DR. NADZAM: I am Deborah Nadzam. I am the vice president for performance measurement at the Joint Commission on Accreditation of Health Care Organizations.
MS. COLTIN: Okay, again, we are going to take the speakers in the order they are listed on the agenda. So, Mr. Hamm, you would be first.
Michael Hamm, NAPHSIS
MR. HAMM: Thank you for this opportunity to testify on behalf of NAPHSIS. As much as possible my comments are intended to reflect some of the concerns that have been expressed over the years by members of the association. In the absence of literal descriptions of diagnosis and procedures, public health statistics is wholly dependent on the coding and classification systems being used in the health industry. Until just recently, public health statistics focused on inpatient events or ambulatory surgical events and therefore have been wedded to the ICD system. Where the ICD system has been determined to be inadequate to represent clinical evaluations or events, public health registries such as birth and congenital malformation registries have had to rely on proprietary list of conditions.
This has resulted in duplication of efforts by hospital staffs since they are required to code for administrative uses of the record using ICD and recode the same medical record for the needs of the particular registry. Therefore, a coding system that reflects the needs of public health statistics as well as administrative needs will hope promote administrative simplification. The ideal system, and one that government needs to support through funding of development and demonstration projects will emanate from an underlying electronic patient record that describes at the most precise detail the condition of the patient.
From the underlying codes in the patient record crosswalks could exist to aggregate the data for the particular secondary purpose that is required, whether it be administrative or statistical. To support this development attention must be given to the design of the patient record and the way in which clinical conditions are recorded in that format to ensure that the needs of the public health statistics are met.
With the decreasing distinction between inpatient and ambulatory events, a single coding system should be developed that covers the broad range of both diagnosis and procedures from inpatient surgical to simple ambulatory events. The advent of managed care encounter data has pointed to the inadequacy of the coding system's ICD, CPT-4 that we currently live with. Encounter formats, as currently design, require the reporter to indicate which coding system is being used for the particular report along with the codes representing the encounter. Thus the user of the data is faced with a system that has incompatible coding structures contained within a single information system and the value of the data, both for public health and health care utilization studies is severely curtailed.
Because coding systems are key to public health analysis, as well as administrative purposes, it is important that the maintenance of the coding system be moved to a public forum rather than continue to be supported by private concerns. This is particularly important if the industry is to move to a single coding system since a public entity will have a better opportunity to represent the variety of needs that the coding system must meet.
A private entity will not unexpectedly tend to put their efforts into the maintenance of those aspects of the coding structure that are most directly related to their business needs. The same public entity should do whatever is possible to ensure that various health data systems use the same version of the coding structure.
Because public health statistics frequently conduct studies over many years, it is also important to minimize the changes from year to year. Thus the forum and the charge of maintaining the system should ensure continuity of the system as a whole and require that codes not be reused in the chance that they be misinterpreted in a multi-year study.
Now I will respond to some of the specific questions. What are the medical/clinical codes and classifications that we use in administrative transactions now? ICD-9 is used for hospital discharge and ambulatory surgery events. This system is not sufficient for encounter data which requires HCPC and CPT-4 classification systems to represent the encounter event.
What medical/clinical codes and classifications would we recommend? Given the time frames it is unlikely that anything other than ICD and CPT-4 will be available. However, some recognition should be given in the report regarding the need to establish a migration path to a single system.
If some version of ICD is to be used for administrative transactions, do you think it should be ICD- 9-CM or ICD-10-CM? Some experts in the public health statistics field report that ICD-10 is not as good for reporting the conditions required by public health analysis. If ICD-10 is selected there should be a coordinated effort among the industry to ensure that all health systems migrate to the new ICD-10 system in the same time period.
Hopefully the field evaluations will point up the weaknesses in the ICD-10 system in relationship to public health data needs and there will be an effort to resolve these problems.
Recognizing the goal of PL 104-191 as administrative simplification, how would you deal with the current coding environment to improve simplification? A single coding system that handles both inpatient and ambulatory events and which also satisfies the requirements of public health information systems would ultimately simplify and streamline the recording as well as the reporting of the data by health care providers.
What are the arguments for having these systems in the public domain versus the private sector, with or without copyright? It is more likely that a public entity maintaining the code set will be able to fairly represent the needs of the multiplicity of data users. Copyright could be maintained and revenue could help support the maintenance and publishing costs.
What would be the resource implications of changing from the coding and classification systems that you are currently using in administrative transactions to other systems? For data providers the initial cost of migrating to a new coding system would be expensive, both in software conversion and training of medical records staff. State public health departments would require similar conversions of software and reporting mechanisms but the long term gains in terms of the reporting simplification and data utility would be tremendous, especially in light of the increasing demand for a utility of linked data systems.
The coding and classification system has been established. Does your organization have any comments regarding the process undertaken? NAPHSIS welcomes the establishment of a government-sponsored initiative seeking solutions for multiple and inadequate coding systems.
Is it administratively simpler to use the same disease classification system for administrative transactions and for statistical reporting? Although it would be simpler, none of the systems as they currently exist are capable of sufficiently satisfying both needs.
What are the impact on and implications for current and emerging medical/clinical classification systems as we migrate toward computer-based patient records? A much richer and more precise classification system will be needed to support the medical/clinical [noise interference] of computer patient records. The current systems need to be revised and consolidated to accommodate the correct crosswalks from the underlying detail that will be present in the CPR. A forum to resolve crosswalk issues from the CPR codes to higher and different levels of aggregation needs to be established.
Another question, is it practical to move to a single procedure classification system on the time table required for initial implementation of administrative standards? Given the complexity and importance of classification systems, the current time table may not allow for immediate adoption of a single coding system. However, the group should not miss the opportunity to establish the policy that the idea of a single classification system is achievable and desirable. The group should establish stage development and implementation dates as well as recommendations for a forum in(?) which the development implementation is to be achieved.
If a medical/clinical code set or classification system is selected as a standard, should providers be able to use all the available codes within the set or system or should those requiring the information be allowed to restrict reporting of certain codes? Because the electronic claim may be used as a source of inpatient and ambulatory surgery health data as it is in New York, it is important not to restrict the codes that are provided. Payers should develop systems that ignore codes that are not meaningful to them and should not be able to reject claims based upon the presence of those codes.
Understandably there is a potential harm in this in that incorrect codes may not be identified by the payer but would be simply ignored. Ultimately provider information systems should be sophisticated enough to generate multiple formats from an underlying CPR record that conform to specific purposes, payer claim, public health report, which would enable payers to screen for incorrect as opposed to supplemental codes.
Thank you for the opportunity to provide these comments. We look forward to working with you on the development of these systems and programs you are investigating.
MS. COLTIN: Thank you. Dr. Dwyer?
Diane Dwyer, CSTE
DR. DWYER: Thank you. I think you have my handout and I will speak from these comments. I think a lot of what I will do is reiterate what Dr. Cross had said but from a slightly different perspective. He was coming from a payer perspective and I think that we in public health are coming from the population perspective where we are trying to actually link the data that he and other payers have into some kind of a meaningful picture of the population.
In Maryland where I am the state epidemiologist, I have been mostly involved with the maternal and child health data sets of how can we link birth, death, immunization and other patient records with public health records? Also the immunization registry that in Maryland as well as in most other states are just becoming, being designed and implemented. Also, I supervise the communicable disease reporting. So, for example, clinicians and laboratories and hospitals that report cases of syphilis or gonorrhea, hepatitis, et cetera, come into our division and are further processed for national reporting.
Additionally I have been involved with the Health Care Access and Cost Commission at(?) Maryland which was a legislated, a law that was passed a few years ago in Maryland that would require each encounter from the entire state population to be reported into a central data base to create basically a client-based, client data base that would have all procedures and diagnoses linked to this as a master data set. It was Maryland's response to health care reform. That has run into problems of confidentiality and is sort of limited right now.
I am here today also to represent the Council of State and Territorial Epidemiologists where I am the chair of the ad hoc committee on electronic laboratory reporting. Where we see laboratory reports as a key way that public health gets information about the population. Because most of the diagnoses that we deal with in public health and communicable disease are diagnoses that are made through laboratories and then could be reported into public health.
So, basically state and local health departments have use for data from a variety of these sources, including the birth, death, hospital discharge, emergency room, provider encounter -- both for the diagnoses and the procedure codes -- laboratory and pharmacy data. And these data can either flow to the health departments directly from the originating source of the data or to the health department through other sources such as the insurers which include managed care organizations, or Medicaid.
Now many of the data are legally mandated to be reported to the health departments, such as communicable disease cases. Most of these at this point in time come on paper, reports, handwritten, or sometimes they are computer printouts from, for example, laboratory computer systems. In terms of cancer registries, the cancer cases from hospitals and pathology labs or lead levels from the laboratories are often reported using standardized electronic reporting. For example cancer programs have some standardized reporting formats and codes and also in terms of the lead reporting, I think New York State was out in the front setting standards. CDC has tried to pull the states together to get a fixed format but I think there is a lot of variability right now.
Other data such as provider encounter billing data or hospital discharge data by diagnosis code or procedure code have utility for public health. And I would give a few examples, some of which have already been given like the immunization data, injury surveillance through E-codes or especially use of these data for other purposes than what they were gathered for. And I think the point was well made by Dr. Cross that these are reimbursement data that we are trying to take and use for other purposes.
One example I would give is what Kentucky did where they tried to find out about antibiotic resistance and overuse of antibiotics and they took Medicaid data and looked at viral, diagnosis of viral infection by the clinician and look at antibiotic prescriptions for viral diagnoses to see the overuse of antibiotics.
We then report from the health department to the CDC but again, there are no standards there. The tuberculosis program versus the STD program and other communicable diseases, as well as public health laboratories, report separately and in different standards of code and format to the Centers for Disease Control.
So we have sought to have some standardization of the format, content and coding. And the Council of State and Territorial Epidemiologists has been working for over the last two years with the Centers for Disease Control and also the Association of State and Territorial Public Health Lab Directors to develop and test transmission standards for submission of electronic lab reports. And I think you have a copy of a handout that basically looks like this. And above the line are basically the things we are trying to standardize. If you think as public health as being below the line, we are not trying to standardize what states do within their own health systems but we are trying to set standards if we are going to approach, if 50 states are going to approach the laboratories and say, how do you report data into public health, then how can we set these different standards?
So overall, the standards would be extremely useful and a lot of times we can use what is out there as we have with the CPT codes and the ICD-9s but it is useful to, we have to specify it.
On the next pages, I will not go into all of the details but I just listed out many of the sources of data in a tabular format and the types of uses in public health. For example, the birth data are not just used for an analysis of the birth data but clearly we are looking to it to populate child health data bases which will be linked then to the death data, adoption data and swing over into independent programs that will capture all of the population of the immunizations.
In terms of lab data, looking at the standards that we have been setting, there are basically the Centers for Disease Control has looked at a specification on Health Level 7, HL7 standard for electronic laboratory reporting that would use the codes of HL7 for this reporting. One of the things that we found is that the codes within HL7 are really inadequate and really do not exist for the laboratory test. And to that end, we have worked with the LOINC Committee which is the Logical Observation, Identifiers, Nomenclature and Codes. And to get for public health purposes the list of diseases that would be reportable for public health and what would those codes be. And that would just be the test, not the result. So then we have to have a code for the result and we have looked to the SNOMED codes for that as the result code.
So I think for provider offices, you know, all of the information that Dr. Cross mentioned about the limitations of encounter-based data, we clearly are looking to have the encounter-based data fill the immunization registry but with all of the caveats that were mentioned.
The HEDIS measures, the doctors would really like to have some standards for HEDIS measures and they have asked us in Maryland to put out software when we put out the immunization, software into the offices to capture the HEDIS measures because their fear is that because HEDIS measures have to be captured that each payer will develop and require the use in the clinician's office of their own software for their patient population which, if there is no standard, will then mean that the provider offices will have to comply with several different standards for their small patient population.
So, our current administrative transactions are limited a lot to the reports that are legally mandated and those, really we have our own coding systems, or the use of data for other purposes. And rather than reiterate a lot of the things that have been said about the questions to be answered, I would only look at the top of the fourth page just to mention a few of the strengths and the weaknesses of the current billing data. Clearly the CPT and ICD codes are critical. The HCFA 1500 as a standard for data transmission format is well used. I think we have looked a lot about HL7 as another possibility, I guess, in the billing arena. It is more X.X12 but I think that we have looked more to HL7.
In terms of the weaknesses, an example of the insufficient detail for CPT codes, we recently had use for a list of providers who see prenatal visits because we are having a syphilis outbreak. So we thought, well, gee, if we could just go the Medicaid data and look for prenatal visit codes and then find the providers we could target them for education. But we found that, in fact, there are not CPT codes for prenatal visits.
The inaccurate coding leads to a lot of problems such as not having the diagnosis at the time of the provider visit. So if we want to run our communicable disease reporting, if we want, say, syphilis reports, gonorrhea reports, hepatitis, a lot of times when the patient is in the provider office the CPT would just say brief office visit, establish patient. Even though the person was jaundiced they have to wait for the lab results to come back to reach a diagnosis to then report which means that they are not that useful for our purposes.
And incomplete coding is clearly a problem. Codes, for example, do not exist for administration of vaccines as an individual vaccine. So there is a CPT code, for example, for MMR, measles, mumps, rubella vaccine. But for administration of Measles, Mumps vaccine there is not one and when vaccines for children program came in, we do not reimburse, we reimburse the cost of vaccine under the CPT code. We have to create our own codes to readminister it to reimburse for the administration of the vaccine which the government gave to the office. So we had to create our own codes for that.
And finally, for immunization data the HCFA 1500 does not have space for the coding for the manufacturer and the lot number for each CPT code for the vaccine administration so we are limited somewhat in running a full registry because we do not have those data. And I provide other comments but I would be happy to answer questions. Thank you.
MS. COLTIN: Okay, Dr. Nadzam?
Deborah Nadzam, JCAHO
DR. NADZAM: Okay. Thank you for having the Joint Commission, accommodating our travel schedule and putting us on this panel this morning.
Our experience with the actual use of coding systems relates primarily to performance measurement activities. We have significant experience in this area in that over the past ten years we have been developing and testing performance measures in hundreds of hospitals across the country and have also implemented our own performance measurement system which includes a patient level data base populated by participating hospitals in the system.
Now this system, the indicator measurement system, and other performance measurement systems now under contract with the Joint Commission to provide data for future accreditation activities, typically use various coding and classification schemes to facilitate performance measurement activities. We know we are not the only ones interested in reliable, valid and comparable data for making decisions about organizations and think that some of our experience then may be of interest to the panel.
Of concern primarily are the differences in coding and classification systems which complicate comparisons of performance across organizations. Although it may be argued that standardization of the performance measures must occur to accomplish these comparisons, the measures often depend on the coding and classification schemes, either to identify the patient population of interest, to identify the event of interest or to risk adjust an organization's rate. So the measures are affected by less than optimal use of even good coding systems as well as by the use of different systems in different organizations in different settings by different performance measurement systems offering the services of the performance measurement.
We would agree that one coding and classification scheme is desirable but it appears that none of the current ones can do everything. Therefore selection of only one of the current systems would probably lead to deficiencies in either particular settings or for different purposes.
If the committee determines that only one system should be used, we believe that a new system or some combination of existing ones would need to be developed which would accommodate the needs of various care settings including diagnoses, procedures and purposes.
The strengths of the current systems do relate to the fact that they are universally accepted and used in the settings for which they are designed. Current weaknesses are probably most related to the timeliness of updates, and it is our impression that this is really a function of the necessary consensus-building activity that must occur for adequate updating.
We believe that the activities and structure of coding and classifications should be government controlled or regulated but perhaps privately managed. In either case the information that described the coding and classification system should definitely be in the public domain for consistent application, including copyright being maintained to prevent haphazard or local level changes.
An additional weakness of the coding systems that we have discovered in our research related to performance measures of course relates to the accuracy of the coding, and we believe that greater emphasis on training and certification of coders and auditing of coding accuracy might alleviate these concerns.
Finally, it has been our experience that the timing of the coding process can also affect the validity of the coding. For example, coding a diagnosis, or in some instances even a procedure, prematurely before the episode of care ends can, in fact, affect the validity. Retrospective coding is looking at all the facts as they have been collected through the, at least, hospital stay.
Changes to current coding classification systems or the introduction of a new one would certainly have significant ramifications for practitioners, providers, information systems, whether they are typical hospital information systems or performance measurement systems. Financial investments are the most obvious but acceptance, training, cultural and trending issues tracking that performance data over time would certainly be affected. We would be affected primarily in the area of performance measurement integration activities recently announced as they relate to our accreditation plans for the future. These plans will have the health care organizations seeking our accreditation selecting a performance measurement system which is contracted with us, having that system then submit to a Joint Commission data base aggregate data for measures that they want us to look at in accreditation activities. These will be quarterly submissions of data, monthly data points, all of which are likely to be affected by data captured in a health care organization.
So this area is of significant interest to us in that it is affecting our future way of accrediting health care organizations. This is not to imply that we do not believe changes are necessary, only to continue to look at the effect on the field as migrating to one system or greater standardization occurs.
Also of significant concern to us is that current systems have not been developed to monitor performance on the quality of care. Ideally a classification system and standardized data set would include necessary information for monitoring the clinical performance of health care providers, both practitioners and organizations. And as more care is provided outside of the acute care hospital, these classifications must accommodate other settings. To that end the ability to follow patients, in quotes, from one setting to another would facilitate performance measurement and the ability to track long term outcomes. Consistent coding methods or and/or the ability to crosswalk between setting specific coding methods and the availability of the unique patient identifier would be necessary to accomplish this level of performance measurement.
In addition, we are concerned that limiting the number of codes captured and utilized would negatively affect performance measurement activities since health care providers would be forced to select those codes for which they would receive payment and perhaps not include diagnoses and procedures the patient experienced that are important to performance measurement activities. The inclusion of E- codes, the greater use of V-codes for obstetrical populations and some attempt to capture co-morbidity versus complication would also assist, particularly as we look at risk adjustment activities.
Finally, the purpose of any acceptable scheme must be clear as previously noted, as I have read through the minutes of various testimony and offered to in the past, the lines between financial, clinical and administrative purposes are becoming less clear. However, current coding and classification systems have been developed with specific, limited purposes in mind. We would really like to see standardization of the data set and coding system with known multiple purposes in mind. Ideally data for performance measurement activities would be a byproduct of data captured for administrative, clinical and billing purposes.
Thank you for this opportunity to provide our comments.
MS. COLTIN: Thank you. Questions? Jim?
MR. SCANLON: I will start off. The, I guess the one implication of the diagnostic coding system that we have not brought up this morning was for mortality classification. In the states the states actually code cause of death, multiple causes and so on. How do you see the suitability of how well the ICD-9, whether classification systems suit those purposes. Birth records as well.
DR. DWYER: I guess I do not feel like I am probably the person to answer that. I know that we use them routinely and they are sort of the norm. I do not have any specific comments on things that they would change. I can provide that later.
MR. VAN AMBURG: Jim, I might try and answer that any way. I think the states are moving towards a more generic process for the coding of the death records in which literal entries are handled and we are letting the software determine the coding structure. And it could be either ICD- 9 or it could be ICD-10. So states are going to be getting out of the business of actually assigning codes and letting software do this. But we are looking forward to ICD-10 being implemented, hopefully concurrently with the CM version as well because states are involved in coding both types and using both types of data.
DR. DWYER: I might make one comment that I know that we have done some audits in Maryland to look at the accuracy of the birth certificate versus the clinical record and found that it is usually an issue of omissions. You know, that there are things that, it is the person who codes the actual record omitting certain birth defects, for example.
MS. COLTIN: Okay, Liza?
DR. IEZZONI: Everybody has been pretty enthusiastic about ICD-10-CM so far in our testimony but, Mr. Hamm, you were not as enthusiastic. You said in your testimony that some experts in public health statistics report that ICD-10 -- I do not whether that also pertains to ICD-10-CM -- is not as good for reporting conditions required for public health purposes. Can you give us a little bit more insight into that comment?
MR. HAMM: Unfortunately, I do not have specific examples but I will get back to you on that one, look into that.
DR. IEZZONI: I think that will be important.
MS. HUMPHREY: Just to follow-up on Lisa's question --
MS. COLTIN: Come down to the microphone.
MS. HUMPHREY: Does your comment refer to 10 out of the box from WHO or does it refer to CM?
MR. HAMM: 10 out of the box.
MS. HUMPHREY: Because I know that there, that just for the information of everyone here, Donna Pickett and Marjorie could do this better than I, but I know that, for example, there was a comparison done and then extensions for CM made because, in fact, ICD-10 as it was out of the box did not cover all of ICD-9-CM because of the delay in implementation so that it might actually be a comment that some of the things that are available in 9-CM, which will be available in 10-CM, are not reflected in 10 out of the box.
DR. IEZZONI: Yes, that is why I would like to have clarification on that, too.
MS. COLTIN: George?
MR. VAN AMBURG: This is a question for Dr. Dwyer. In your testimony you kind of hinted that public health has a lot of specialty coding systems and they operate a lot of registries which use unique coding systems. Cancer registries use ICDO; birth defects registries use their own system; you have the communicable disease reporting which is handled another way in laboratory. How do you see all of these different coding systems being fit into administrative simplification and where public health is going with this?
DR. DWYER: I think one thing that has been talked about is having these various systems at least specify a standard for importing data into them so that, let's just at Maryland that we kept it all in an oracle data base, we could still communicate our TB data to the TB system at the CDC because they would tell us what formate to put our data in to bring it up to import it to theirs, or export it to theirs. The same with STD.
I guess we have just really been trying to figure out, like, for example, for our immunization registry and for our child data base we have been saying, let's pick the birth certificate variables and their coding scheme so that we would then migrate to that in their other data bases that we current have. Because, as you say, hereditary disorders and hearing and vision, those all are just homegrown, their own system. So we have tried to say that at least for the child health data base we go toward the birth certificate date.
Again, I think that we have not really addressed this in public health because each of the states [noise interference] very different.
MS. COLTIN: Follow-up?
PARTICIPANT: It is a different subject.
DR. COHN: I was actually just going to comment on your question, which I thought was an excellent question, I was actually going to remind the group of the panel at our last full committee meeting that talked about the issues around integration of various codes and code sets, and I think what we are seeing is a very vivid example of that, about the fact that, you know, even when we talk about sort of one size fits all or a single unified X or Y, in reality there are different code sets that have different purposes and we need to figure out ways to integrate them all together. It is not likely that we are going to come up with one that is going to solve all the problems. And I think that might, thank you, Dr. Dwyer, because I think you came up with some great examples of that.
DR. DWYER: And, for example, just to integrate our data that we have on communicable diseases in the Epidemiology Office, which is basically cards that get reported from physicians that we stick into a data base at the info, and we get the lab data that is in the Public Health Lab Information System, or PHLIS, we just cannot integrate them. Even those two sort of CDC grown systems, we are having, we have major problems. And so we just reenter the data.
MS. COLTIN: George, did you have another --
MR. VAN AMBURG: Yesterday we had some testimony about some of the problems of the accuracy of data obtained out of the medical records pulling systems which have vital statistics. Many state epidemiologists and state public health statistics people use that data for analyzing health problems in a given geographic area. Can you comment about your feeling about the usefulness of the currently coded data as far as for that purpose?
DR. DWYER: Well, clearly we would like to use it and I think as I mentioned, for example, now when you are talking about the data this would be, say, Medicaid billing data?
MR. VAN AMBURG: Yes.
DR. DWYER: As an example because we have access to that. Again, we would like to use it but it has all of the limitations. For example, in Maryland a lot of our children are capitated and so we do not have encounter-based data. And even if you say that in capitated plans they shall submit an encounter form for each child because we want to capture the immunizations, I would go back to Dr. Cross's comment. If it is not reimbursed then there is not the incentive for really being compulsive. And I think the compulsive person who really tries to code the birth accurately, the death accurately, everything that is done in a clinician's office, even just ICD codes in the clinician's office, you know, it is an established patient, brief office visit, but what did they have? So, they had tendinitis. Well, that is not on the encounter sheet so how does the clinician find what the ICD-9 code for that is? And it is not straightforward and I think that those kind of inaccuracies, I think, limit what we can do. Again, I just reiterate that reimbursement is real separate from the data and we would like to think that we can use them but it is a challenge.
MS. COLTIN: Jim?
MR. SCANLON: I would like to ask about sort of the distinction I think you are making, Dr. Dwyer, between the two types of public health, the way public health could use some of this data. It seems to me there is the communicable disease, more or less, time-limited reporting where the local health department or the state health department would be expected to intervene in some way, hepatitis at a college dorm, or something like that. And there is a very tight time frame there, probably required reporting within a certain amount of time when a provider comes across a case.
The other sort of situation is more where there is less of a time constraint and it is the population at large and what is happening. Do you see this standardization effort where potentially there would be standards for claim data, enrollment data, this sort of thing, and I do not know that it would help the first that much but clearly is there potential for helping the state, for example aggregating some of the population-based data and understanding what is happening in the state that way?
DR. DWYER: Right, the first clearly is why we are focusing on laboratory reporting because that is probably going to be the most timely, that we can have daily transmission. The second clearly is, I think, the standards are terrific. I think that the more data that we can get that way the better and clearly I think that as the clinician sees the data being useful and the MCO sees that the data are useful, for example linking lab test results on diabetics with the diabetic products with the outcomes, then I think that there is the motivation to keep the data more accurate.
I think that sometimes that it has been looked at for rare diseases, though, and the miscodes are greater than the actual number. I think in New York they looked at their system for state employees, their insurance data, and found that they had a huge number of typhoid fever cases and, you know, they had not seen typhoid fever much in New York. And then they looked at the procedures related to typhoid fever and it was like oblation of a benign lesion which did not seem to fit either. And then they figured out that it was that the ICD codes were so close to like a benign skin condition and typhoid fever that just the trans -- you know, that kind of thing, I think that, you know, when we are trying to look. For example, we try to see, do we have all of our pertussis cases? So we try to link, look at the hospital discharge data using the diagnoses of pertussis. But, you know, then we get into other limitations like, well, but the name is not in the hospital discharge so we have to try to pick a combination of unique identifiers or, you know, age and all that, to match it up.
I mean, we really have great hopes and we really want to try to use it. I think clearly one thing that we can do is work with specific MCOs, for example, like maybe Kaiser, who has a model where they have computers in the doctor's exam rooms and they have a better data system to actually look at populations.
MR. SCANLON: Can I follow-up one question? You made reference to a confidentiality issue in Maryland that prevented some sort of a hospital discharge abstract system, I guess. Could you say a little more?
DR. DWYER: Yes, actually, we have had a hospital discharge system in Maryland for a long time and it has gone very well without any challenges to the confidentiality. Essentially we were setting up a system just like that for out patient encounters and the data would have been really captured and captured in about the same way. I think the issue around confidentiality arose with self-pay. So if patients do not get their service billed should they go into the data base? And that became a big issue around psychiatric visits.
So, do we need to have every, because some people self-pay because they do not want their information going to their insurer and so, you know, what would the response of the psychologist and psychiatrist be? Would they not report the data? You know, would they discourage people from using their insurance because they, you know, even to say, you know that if you use your insurance it will all go into this big data base that, you know, we are concerned about.
So, I think that, you know, it was, it got very concerning, both for the self-pay and, so, I think at this point in time there have been changes in the state law to say that you cannot collect the day of birth. It is month and year only. And at this point in time, it is sort of voluntary reporting from payers. And, I think, you know, that leads to all sorts of questions about when you analyze the data and it has been a voluntary and somewhat not universal system, then when you get out rates and costs and things that we have to look at how comprehensive are your underlying data.
DR. IEZZONI: The Joint Commission accredits other health care organizations beyond hospitals. Increasingly you are moving to looking at home health, health plans, nursing home long-term care facilities. We heard yesterday that the standard code sets, the ICDs and the CPTs do not work that well, for specifically yesterday, home care. But we also, I think, will be hearing in our June meeting about long-term care facilities. Can you comment a little bit from your experience about the ICDs and the CPTs and the other standard code sets as they pertain to these other health care settings and how it affects your accreditation activities?
DR. NADZAM: Sure. Actually home care is now our largest accreditation program. We had some performance measures a few years back that we began testing in voluntary home care organizations. They were not based on codes at all. In fact, they typically identified patients with, receiving particular services and the home care agency had to find out how to identify those patients. We have a few performance measurement systems in our initial list of contracted systems that indicate they are being used in those settings and as we move to learn more about the actual measures in those systems, we will learn more about how they are identifying them.
This spring we are conducting some field questionnaire surveys of all of our accredited organizations in those other settings; home care, behavioral health, clinical labs, ambulatory care and long-term care pharmacy, to assess the state of measurement in those areas. So, that is about as much as I can share at this point. It is, certainly the professional registry of record analysts who work for the Joint Commission coders, have informed us that we are embarking on new areas as we try to assess performance in those areas. So, that is all I can share at this point.
MS. COLTIN: Okay, are there any questions from the audience? George, did you have a question?
MR. VAN AMBURG: I have a question for Dr. Nadzam on performance measures. Many performance measures require outcomes and an out-process list(?) and may require, at least at this stage, linkage of [unintelligible] data bases, some in the public sector, some in the private sector. What direction do you see this going in the future for performance measures?
DR. NADZAM: We would like to see the capability of following a patient across settings. Some of the outcomes we have tried to test in the past, and I say try because in some cases we have not even gotten them into testing, others we have tried, require the first health care organization to find that patient later or track them through the health care system and there is no way of doing that.
So, to really get to measuring post discharge outcomes or long-term outcomes, which I think is something we all would like to do, will require that linkage. And if that is not through data base, well, through data bases it will still require that unique identifier that picks up the individual patient.
One other comment, if I may, that we have sensed throughout our years of testing performance measures is that even though there has been an increasing cry for standardization from the provider organizations, whether it is from measures or the data they have to collect that compute the measures, we sense that there is almost a fear of that same standardization. Because once everything is standardized accountability becomes a little tougher.
MS. COLTIN: Okay, any other questions? Betsy?
MS. HUMPHREY: I think I know the answer to the question but I know that in the nursing area there are at least two systems that have been in use for a fair amount of time. The Omaha Visiting Nurses System and the Home Health Care Classification which was developed by Virginia Saba at Georgetown. I think she is here, actually. I saw her earlier. And I just, I know they have been used, to a certain extent, anyway, in terms of home health care delivered by nurses.
And I know that the VA in developing its clinical lexicon, for example, was quite interested including the Omaha Visiting Nursing System because they, I guess, under some circumstances, must have been using it because that was one of the things that they added. So, I just wondered whether you would run across that, either of those systems being used in these home health care settings?
DR. NADZAM: Yes, I think we have seen them used. We have not used the data yet in our accreditation activities --
MS. HUMPHREY: To see how useful it is to you for that purpose?
DR. NADZAM: Correct.
MS. HUMPHREY: So it is not that you do not, you just do not know the answer to that question?
DR. NADZAM: Correct.
MS. COLTIN: Okay, I think we are going to break early. And doing that, I would like to start early as well. So, if we can be back here at 12:45 p.m. and start fifteen minutes early, I would appreciate that.
[Whereupon the meeting recessed for lunch at 11:40 a.m. to reconvene at 12:45 p.m. that same day, April 16, 1997.]
A F T E R N O O N S E S S I O N [12:50 p.m.]
MS. COLTIN: We need to get started. We are already running a little behind. We are some of us invested in trying to end at 5:00 p.m. today so we are going to try to keep on schedule as much as we can and perhaps even shorten the afternoon break a bit to make up some time.
So, I would like to get started. The next panel is the panel on Federal Agency Data Uses and I believe almost everybody is here. But, I guess, -- everyone is here. Oh, you are all set up, great.
Okay, we will, again, take the presenters in the order they are listed. So, feel free to start.
James Summe, AHCPR
MR. SUMME: I am Jim Summe. I am with the Agency for Health Care Policy and Research. Myself and the group that I am representing here today is in the Center for Cost and Financing Center. The group I am with has a fair amount of experience in using claims data, claims data from a variety of sources and we have both, both used it for internal studies and we have been involved in supporting our researchers in using many of these data as well.
I thought it was most germaine for us to basically address questions 1 and questions 4. These are the questions that we felt that our experience was most relevant to.
With respect to the codes, we have seen problems, as other people have recounted here, between the codes used on the inpatient side, the ICD procedure codes, and the codes used on the outpatient side, the CPT-4 codes. Even an expensive and common procedure that receives a lot of scrutiny such as CABGS(?), if you look at the codes, the ICD-9 and compare them with the CPT-4 codes, you see different aspects of the procedures broken out. So these codes do not map well from one set to another.
Some of the administrative codes contain a significant amount of clinical content. Maybe some would debate me over whether the amount is significant or not, but they at least contain some clinical content and I would encourage the people working with the codes and working with the standardization to consider including these administrative codes in their efforts to standardize the process. Hopefully the codes, the administrative codes with clinical content would be consistent with the more detailed clinical codes that were used in these data systems.
Some examples are the revenue centers that are used primarily for reimbursement purposes, as well as another good example is the type of service codes. You see different sets of codes depending upon who the, depending upon the data system that you are working with and it would be helpful to readily be able to map these or to see these as collapsed sets or aggregations of the more detailed codes.
Oh, let me not skip my last point here which is we appreciate that there is a considerable amount of effort going on with respect to developing computerized patient records and would encourage the folks involved in the current standardization process with respect to HIPAA(?) to be as consistent as is possible with the emerging standards with the computerized patient record.
With respect to administrative simplification, let me speak for standardizing the instructions and the codes used on the form as well as the form or the format of the record. The UB82 is perhaps a good example of something that has the appearance of more standardization then is really the case. When you have to pull out a different set of encyclopedias for different payers in order to complete the form then there is certainly significant efforts that could, significant improvements that could be had in terms of further standardizing the information that is being captured in this system.
We would encourage you all to think in terms of minimizing the cost of collecting and providing the data as opposed to minimizing the number of fields on a form. I had, every time I look at a UB82 I have the sneaking suspicion that the OMB requirements were being hung over the people who were putting together and designing the form. SO they seem to want a one-page form and then if you have a field here, well, you use that field for as many things as possible. And so you get a code, a rather deep code set that sometimes, it certainly has provided challenges for us in terms of trying to interpret and understand at times. It also provides challenges in terms of trying to work with these data with modern data base tools and I will talk a little bit about this later.
There are a number of fields on the forms that apparently are never used. I would like to see them used but insofar as they are not used they should be dropped. Ideally we would like to see every field that was in a data system actually be edited but appreciate that we are probably not going to reach that. But what we would encourage instead is that the fields that are not edited as part of the reimbursement process perhaps they could be periodically audited.
One of the things we discovered in our Medicare Accuracy and Completeness Study was that the medical record number field oftentimes contained a room number or a billing number. There were a significant number of instances where we did not see a medical record number in that field.
The cost of collecting data. What we see here is that you need a certain core set of data in order to do the business, complete the business, complete the task of providing the health care service. And so that data should be accessible, should be obtainable without a huge cost. And I think we need to think in terms of the cost of the data as opposed to just thinking in terms of the volume of the data.
And then lastly some perspectives here. It seems to us that an accurate clinical summary is essential for many uses here. It, we would think it would be critical for reimbursement, for accountability, including the fiduciary accountability, that really occurs in providing the service. In other words is the payer paying for something that the patient actually benefited from?
Assessing quality of care as well as research. We do not think that we are ever going to get everything that we need for research or quality assessments out of claims data but the claims data can certainly provide us with an excellent sampling frame. It can help us target groups, subgroups to collect supplemental data on, and it can also be used for general bench marking purposes. Thank you.
MS. COLTIN: Thank you. The next speaker is Jean Harris. Would you introduce yourself and where you are from before you begin?
Jean Harris, HCFA
MS. HARRIS: I am Jean Harris. I am from the Bureau of Policy Development in HCFA. I want to speak about two topics this afternoon. The first one is kind of talk about the first side of data and that is to provide you with a little bit of information about the researchers that are using HCFA data. They are considerable in number. And obviously using data with the existing coding systems.
And then also there have been several references over the course of yesterday afternoon and this morning to the HCFA Common Procedure Coding System, or HCPCS, and I would like to discuss that, especially levels two and three of HCPCS, and describe those for you to fill in a gap in your information base.
Needless to say in the, especially in the Medicaid program, we have quite a wealth of health care data and we realize that that is very valuable to a data intensive industry. We make that data available to outside researchers. We have organized the most popular of our data sets into public use files that we release off the shelf. That is, somebody can purchase a public use file and we simply release it to them. And then, in addition, we respond to requests for customized data sets if the users wants data that is not available in a public use file.
In 1996 we released 1,300 public use files and 3,400 customized data sets. Most of these contained diagnostic and procedure information. They are based on claims data and the most popular of these files are those that include diagnostic and procedure code information organized and summarized in a variety of ways.
These files also are available for a number of years, many of them in series since the 1980's, making longitudinal research possible. Another indicator of the interest in our data is that periodically we hold conferences for users of our data to assist them in understanding the data and in understanding changes that are made over time. One of those conferences is being held this week and is drawing about 400 attendees.
TO move to the Common Procedure Coding System, it consists of three levels. The first level is the AMA's CPT or Physician's Current Procedural Terminology. Level two contains codes for a wide range of services, supplies and equipment and devices which are covered by the Medicare and the Medicaid program and to some extent by other payers. But these are services and supplies and items which are not included in the CPT. The level two of HCPCS is jointly maintained by the Blue Cross Blue Shield Association, the Health Insurance Association of American and HCFA.
And then level three contains a relatively small number of locally developed codes for services that are not included in levels one or two but are needed to meet unique situations.
There is some statutory basis for HCPCS. The Omnibus Budget and Reconciliation Act of 1986 requires the use of HCPCS for services in hospital outpatient departments and then the Omnibus Reconciliation Act of 1989 required the Secretary to designate a common procedure coding system to be used for physician services and HCPCS was designated for that purpose because it was already in wide use and well established.
To give you some idea of the volume of claims that we handle using HCPCS codes, in 1995 they were used for over 700 million claims. You heard earlier today, and I would just reiterate, that a change in coding system when we are using claims in those volumes, would cause quite an impact on us, and also when you are dealing with the dollar volume that we are dealing with, establishing the right price for new codes is certainly a very critical activity.
To provide you with some history of how HCPCS evolved, in the late 1970's, Medicare decided to adopt a uniform coding system for use in the Medicare and Medicaid programs. We adopted CPT for physician services and it is also used for the services of independent laboratories because it was already established and in use and maintained.
And we subsequently started to use CPT in hospital outpatient departments to report radiology services, laboratory and other diagnostic procedures. And then finally it is used by ambulatory surgical centers and hospital outpatient departments to report ambulatory surgeries.
The purpose for using CPT both in the physician arena and in the ambulatory outpatient type arena is to be able to do comparisons and costs in the two arenas and to be able to establish limits in one arena based on what we are paying in another arena.
No comprehensive coding system was available, though, for a variety of other items and services that our programs covered and we concluded that we needed to develop a coding system. So the result was level two of HCPCS which contains over 2,800 codes. The codes cover ambulance and other transportation services, medical and surgical supplies, durable medical equipment, injectable drugs, orthotic and prosthetic devices and eyeglasses. There are also codes for dental services and a few codes for physician services and services of other practitioners.
The level two codes consist of five characters, but to distinguish them from CPT the first character is alphabetic. The primary users of level two of HCPCS are the ambulance services and companies which provide those medical services and supplies that I described earlier. It is also used by physicians to report injectable drugs that they provide in their offices and then some physicians dispense some of the supplies that are also included in level two. Examples are splints and braces.
Hospital outpatient departments make limited use of level two codes, using them primarily to report durable medical equipment, orthotic and prosthetic devices, occupational therapy services and the drugs used in chemotherapy.
In 1995, the total Medicare allowed charges for level two codes was $9.8 billion. Decisions regarding additions, deletions and revisions to level two are made by an alphanumeric editorial panel. The panel meets three times a year and has representation from the Blue Cross and Blue Shield Association, HIAA and HCFA. There are formal mechanisms to coordinate this panel's activities, both with the CPT coding maintenance process and with the ADA coding maintenance process.
HCPCS updates are released annually. Both print and electronic versions are available through the government printing office and a number of other vendors offer them. The print version of 1997 HCPCS from GPO costs $28 plus shipping and handling.
A section of HCPCS is reserved for each of the three payer organizations that maintain HCPCS. The purpose of this is to permit them to establish codes to meet the unique requirements of their respective programs. We in HCFA use this mechanism to establish codes quickly in response to statutory changes, to new technology, or to react to fraud and abuse. Codes that are established for physician services in the section that HCFA maintains, at least, are usually incorporated into a future addition of CPT.
Then a word about level three of HCPCS. It is somewhat similar to what I just described in level two in that it is an opportunity for payers to meet their unique needs at the local level. These local codes may be necessary to reflect variation in local statutes -- for example, mandated benefits at the local level -- variation in scopes of licensure or emerging technology being used in only a few institutions which payers want to pay for or they may want to code so they will be sure that they do not pay for it.
HCFA's regional offices assure coordination of local code assignments among the payers in a state and local codes must be approved by HCFA's central office to assure they do not duplicate national codes that are in either CPT or level two. Yesterday, if you recall, there was a question about the types of things that cause level three codes to be established. As I was preparing to give this presentation I asked for some current examples, and let me give you one current example. The state of Missouri has just passed a statute -- well, I do not know whether it was statutorily or administratively -- but at any rate, they have extended the scope of the podiatry license. Podiatrists can now perform surgery on the ankle as long as they are working under the supervision of a fully licensed physician.
So the payers in the state of Missouri would like to establish a local modifier which podiatrists could then append to their claims when they report that they are doing a surgical procedure on the ankle to indicate that they were indeed supervised by a fully licensed physician, obviously assuming they were, in fact, supervised by a physician. So that is an example of a very specific local need that caused people to request, in this case, a local modifier. Thank you.
Kathy Huntley, FDA
MS. HUNTLEY: Hi, my name is Kathy Huntley and I am here to represent the FDA in some of the work that we are doing and also at this part of the presentation to talk to you a little bit about the data uses and the data standards that we have within the FDA.
One thing I just want to remind everybody, maybe it is political at this point between FDA reform and [unintelligible] negotiation and everything else, the reason that there is actually, currently an FDA is that we are a regulatory body. So the information we collect is not something that we request, it is information that is sent to us to review, to comment on and to either approve or disapprove for a marketed product. But it has to do with everything from foods to devices to the stuff your dog and cat takes, to what your kids, to the vaccines, the whole kit and caboodle.
Anyway, what we also do is we regulate all foreign and domestic products that deal with foods, as I said, devices, human and animal drugs and biologics. We conduct a pre-market review. We monitor the post-market safety. We do the inspections of all facilities. Those are the inspections of the clinical trial facilities, the manufacturing facilities and the toxicology facilities. We regulate $1 trillion worth of products. So twenty-five cents of every consumer dollar has to do with products that we regulate.
The massiveness of what we receive is not in the 700 million type claims that we just heard from HCFA, but, in fact, some of our submissions come in by the truck. They are pallet-size. They come in, and being an ex-reviewer, having 100 to 200 volumes plopped in your office is not the most pleasant understanding.
We also receive, for example, 170,000 adverse event reports just in the Center of Drugs. Now when you talk to our industry, our industry being all the industries that deal with the manufacture, the testing, the electronic submission(?) and the coding of anything to do with a medical device, a biologic, a drug, an animal product or a food -- which is a massive industry -- one example we were given is they pay $250,000 to photocopy the adverse events that they report just to one center annually. And we are one of 41 international regulators they have to submit to. So these are some of the issues and why our industry is trying to push us to work in the way we are. But this is just to give you a flavor of where we are.
Current situation is we are actually working here with multiple terminologies -- just like all of you -- but in the drug development process which is not exclusively different from what you are talking about here. It is, in many cases, the same providers, the same hospitals, and in some cases the same patients. Some of it is a reimbursable, some of it is a clinical trial. But what we are trying to do is to work across the continuum and to make sure that what we do supports it.
Now, people have talked about the terminologies. We as regulators -- and this is regulators internationally, this is not regulators FDA -- FDA currently does not have a required terminology. We have policy but we do not have a requirement. That is not an easy thing for a regulator to do. Anyway, as regulators worldwide some use ICD-9, some use ICD-9-CM, some use ICD-10. We deal with global companies so we cannot set national standards. We must work internationally. Our industry, ICD-9, CM, 10, SNOMED, homegrown, lots of homegrown.
Post-market, the regulators, this is after the product is in we have to collect the adverse event. WHO has the WHO-ART. The Japanese have J-ART which is WHO-ART with about 500 terms to support Eastern medicine not the Western practice of medicine. There is the ADROIT terminology in the UK. We have COSTART at the FDA.
The regulators use the vanilla flavors of those. The industry uses chocolate chip and strawberry because they add the 50 terms that they really kind of needed and they maintain their own. So this is the mess we have in trying to clean up the submissions.
Then we talk to a lot of the groups that are represented here today. The data generators down on the bottom have to create multiple submissions for either multiple drug companies or multiple grant sponsors. And that with a small group at the NCI at NIH they actually had five different terminologies for 16 patients. And they were 85 percent the same terminology but it was that 15 percent that you had to kind of say, well, is this LUCK(?) or is this GlaxoWelcome(?) or is this an NCI sponsored or is this, and it went on and on. So these are the kinds of issues, so we recognize what everyone is talking about.
Then, all that information goes to the data collectors. The contract research organizations are industry. They do a great job in trying to collate it, trying to do a consistent coding. And they send it into the FDA and they say, whoa, we have done all this. We do it again because we are using, everybody is using a little bit different terminology or they did not like the way it was coded so they look at the case report font(?) book. Then we also have blatant examples of seizures being coded as nausea and vomiting and dizziness. So, we can go back and forth on that.
And I am sure, even though Dr. Kessler has left us, I am sure all of you here know about the MEDWATCH Program, the reporting of information. The MEDWATCH Program is not something that we are looking to have pre-coded information sent in. That is our way of getting the professional organizations to send us adverse events. We at the FDA take care of the coding in that.
All of this and all the types of data and the specificity of data that we currently receive and currently request -- and currently is the operative word with FDA reform -- is the reason that industry, our industry has pushed us and pushed very hard that we work internationally. The device companies, the drug companies, the biologic companies, the food companies, the IT companies supporting all those are not national companies. They are international. So we actually are working with and within a group called the International Conference of Harmonization. This is an agreement between the regulators of the European Union, Japan and the United States. We are moving towards a single set of somethings. And I am saying somethings in clinical trial design for the elderly, clinical trial design or the inclusion of pediatrics. One of the areas is in medical terminology which I will tell you later about. Electronic standards for being able to submit the information to the different regions in the same group. The agreement on what data elements are needed for a worldwide safety assessment so Europe does not ask for two different ones than Japan. France does not ask for something that is just one off of England and things such as that. This is what is driving our industry nuts.
So we have done a lot of the scientific work. What we now have moved into is the development of the international medical terminology and the electronic standards for the transfer of that information. The goal is obviously a single transmission that will meet all three regions' regulatory needs.
And that is this handy-dandy chart. So we have the E2B which we now have an international agreement on the data elements for a safety evaluation, both pre and post marketing. We, knock on wood, in July will have our vote on the international terminology which will code those data elements, and we are very close to the agreement on the electronic standard which will then allow that sort of approach.
What I wanted to bring to everybody's attention is we are actually playing with the same set of players but there is an additional level of players that the FDA needs to deal with and that is all the regulated industry that we deal with that depending on your counts can either range in the tens of thousands to the hundreds of thousands, depending on how far and broad that you go. Thank you.
MS. COLTIN: Thank you. The next speaker is Gail Graham.
Gail Graham, VA.
MS. GRAHAM: I am Gail Graham. I am representing the Department of Veterans Affairs and I am from the Amarillo Field Division of the VA.
I am going to proceed to answer the questions as they were presented and will expound on them later. The first question concerning the medical or clinical coding classifications and administrative transactions, we are currently using ICD-9-CM, DSM-4, CPT, HCPCS and we do use the Unified Medical Language System in our problem list which indirectly affects the administrative in the VA transactions.
There are numerous strengths in the current methods for coding and classifications of encounters or enrollment data. One of the most obvious is the historical relationship that we have for data. The biggest weakness that we are experiencing presently is in that of expressing the purpose of visit for non MD practitioners.
The next question is concerning medical or clinical codes and classifications and the recommendations for standards. We would like to see ICD-9-CM and ICD-9-PCS adopted for all clinical activity. In lieu of that if the USA is destined to have two procedural clinic systems it would be of benefit to have a crosswalk between the two systems. We are experiencing, as many others have expressed, difficulties in crosswalking ICD-9 codes to CPT codes in performance measures or our integrated networks, and I do not think we are alone in this difficulty in crosswalking.
Prior to the passing of the HIPAA(?), the National Center for Health Statistics initiated development of clinical modifications for ICD-10. This goes on. Our position with this currently is if the field evaluations are positive we would support the initiation of both of these coding systems. And as an input on here, the Amarillo VA is currently testing ICD-10-PCS and in that we are in the very early, early stages where we are just recoding current records for invasive procedures to the ICD-10-PCS system. What we have found in this preliminary is the specificity that was lacking is present. We are seeing that for our coders that the coders with a higher degree of clinical knowledge are doing better with this system than those with a lower degree. This does rely heavily on very accurate physician documentation to be able to use these PCS codes appropriately. We have not branched into the non invasive procedures in that system as yet so I cannot address that.
Recognizing the goal of PL 104-191 is administrative simplification how from your perspective would you deal with current coding environment to improve simplification? We would recommend the development and implementation of an automated clinical vocabulary which would assign the codes. This would use super coders, the term to be employed to maintain the coding within the vocabulary. An example of this currently being used within the VA is our linkage from the problem list to ICD-9 to [noise interference] CPT utilizing UMLS(?).
How should the ongoing maintenance of medical/clinical codes set(?) and responsibility intellectual input and findings(?) for maintenance be addressed for classification systems in the public domain versus the private sector?
We would encourage to have a system much like, that would avoid any exorbitant licensing fees. The example of this is the LOINC system, the Logical Observation Identifiers, Names and Codes and the VA is currently working with the developers of LOINC to use this in our clinical information resources network to transmit lab data from(?) at the VA networks.
What would the resource implications be from changing from the coding and classification systems you currently use and are using the administrative transactions to other systems?
The biggest priority for us, as with most others, would be the crosswalk development. If this is not developed commercially it would be personnel-intensive to develop this within the VA. And due to our vast research activities in the organization, the transactions, it would be imperative that this crosswalk occur or a great deal of research data would no longer be available.
A coding and classification implementing patient(?) team has been established and we would just like to note that the VA is a member of this team and an active participant.
Can one system serve most if not all of the purposes of critical care surveillance, quality assessment and improvement, research and billing management? A good clinical vocabulary linked, when necessary, to different coding and classification systems can serve most of the purposes addressed in this question.
An example of this is the SNOMED or Systemized Nomenclature of Human and Veterinary Medicine. It could serve some of these functions. However, the many different classifications of SNOMED would really make it extremely difficult to teach in the sectors of those teaching and preparing people for coding positions.
We do feel that this is the building block of this whole transmission of information. That a good clinical vocabulary is the core to the issue.
The next question about should the administration coding be used the same for statistical reporting, and we feel, yes, but it should be more of a case where the clinical information feeds to the billing information and not vice versa as in the case that we really have at this point.
To what extent do you feel that your discipline and practice settings are well represented by current systems for coding health conditions, diagnosis services, et cetera?
Currently the VHA provides many services which are not covered by either ICD-9 or CPT. These are non physician services which are beneficial to a patient's health status. A few examples of these are dental or prosthetics and a wide variety of nursing care that is rendered.
What issues do you encounter linking data coded with different classification systems in trying to crosswalk between armor(?) and classification systems?
The classification systems are too disparate at this point. They focus on different issues. One is narrow. One is broadly focused and vice versa. Thus you end up with a messy crosswalk. And another example of this is again the trying to crosswalk the ICD-9 to CPT for performance measures. Currently we are trying to rate the usage of ambulatory surgery and the degree and the percentage within the medical centers to which this is being utilized. The present crosswalks that we have available to us have not really offered a good relationship between these two fields.
What are the impacts and implications for current and emerging medical/clinical classification systems as we migrate to the CPR?
The different systems in use may lose some of the power as a true clinical vocabulary comes into being. All major classification systems currently in use should be used in any vocabulary for the CPR. Crosswalking relatively easily is a very subjective term however it will be essential to trend data historically.
Is it practical to move to a single procedure classification system on a time table required for initial implementation of the administrative standards?
It is not only practical but it is necessary to measure outcomes and to review information across a continuum. And given that ICD-10-PCS is totally new we would encourage a phased-in approach and beginning with inpatient or the lower volumes and then migrating towards hospital-based ambulatory care and then into the physician or clinician's office.
If a medical/clinical code set or a classification system is selected as a standard, should providers be able to use all the available codes within the set or system or should those requiring the information be allowed to restrict reporting of certain codes?
We would certainly promote and encourage that these codes be open to all types of providers. At this time within the VA we designate the provider type to further delineate that for any outside person looking at the data so that that is apparent to them. But it, codes should not be restricted.
Thank you and I thank you for this opportunity to present our view.
MS. COLTIN: Thank you. Okay, and our last presenter is Dr. Burt.
Cathy Burt, NCHS
DR. BURT: Hi, I am Cathy Burt from the National Center for Health Statistics, part of the Center for Disease Control and Prevention. We have the charge to monitor the nation's health and we do that in many ways through vital statistics, through population-based surveys and examinations and through provider surveys. And I would like to represent the provider end of the Center because we are the only place within NCHS that actually uses medical diagnosis and procedure codes.
Our provider surveys are part of the National Health Care Survey and we measure hospital inpatient, outpatient, physician offices, nursing homes, a broad variety of providers and we collect data on the medical diagnosis provided by the physician and any procedures that are done. We also in some of our surveys collect data on the patient's reason for visit and for that we use reason for visit classification which we have developed and been using for the last 15 or 20 years.
For the medical diagnoses we use the ICD-9-CM. We used ICD-8 before and we will probably use ICD-10 if it goes to that. We try to provide trend data over the last 20 or 30 years which means the data has to be able to be comparable across all those years.
For procedures we use the ICD-9, Volume 3. We tried using CPT-4 but we were prohibited from publishing the data, the name of the code and the code because it was copyright infringement. So we therefore do not present that data. We would have to have recoded everything for presentation which we did not think was worth it.
So that is what we use and how is our data used? We put our data out in public use form in terms of files and publications. We get over, about over 10,000 requests each year in our division for data, medical data in these different kinds of provider settings. And the data is used by many researchers, internationally and here, to examine provider trends in terms of treatment patterns or by epidemiologists in terms of risk of getting diseases, et cetera.
I mostly, instead of answering all these questions, wanted to talk about what is important to us in terms of a classification system. And that is, one of the main things is that it be hierarchical so that it can be either aggregatable or collapsible. I do not know if those are words or not, but you know what I mean. We like to collapse categories because we may not have sufficient examples from a national perspective to produce statistics and maintain the confidentiality of our data. So we need to be able to collapse it.
We need the data to be consistent over time. If a code is added we do not want it to mean the same thing that the code meant two years ago. That is very annoying. It has to be consistent. If you are going to add a code, fine, but do not give it the same number as something else.
It has to be reproducible for publication purposes. We cannot be saying, well, yes, you can collect this all you want but you cannot publish it. That is not good for us.
And finally, it needs to be a complete classification system. In other words, everything that is written down must be able to be put some place. Unfortunately that means we do need to have a not otherwise specified category on almost everything that you can have because the data that we collect does not necessarily have specific, sufficient specific information to apply the correct code.
And finally we would like the data to be linkable to mortality statistics. We would like to be able to say that there were this many deaths for this condition but there were this many illness cases or this many doctor visits for this same thing. So for that we would like the codes to be related.
I think that is about all I want to say unless there are some questions we might have about how we use the data.
MS. COLTIN: Thank you. I think at this point I will open it up for questions to any of our panelists. Lisa?
DR. IEZZONI: I am interested in hearing from Ms. Graham about the VA. The VA has wonderful programs for spinal cord injured veterans and people with other physical disabilities and I wondered, I know ICD-9-CM does not have very many codes that describe functional impairments that reflect useful clinical information about types of disabilities. Have you found that to be true and have you tried any other coding systems to try to code patients in your spinal cord injury units or your other places where you care for people with physical disabilities?
MS. GRAHAM: Right now we are pretty much around the parameters of what is mandated partially because we need to communicate our data with other researchers and people so the VA has really tried to stay away from making internal coding systems that only mean something to the VA.
DR. IEZZONI: Do you use the ICIDH, like the International Classification on Impairments, Handicaps or Disabilities and Handicaps?
MS. GRAHAM: No, it is not one that is in our data base now so we, the problem we are addressing currently is the VA just recently really started to focus on the ambulatory coding part of the house and the spinal cord injury units are one of the units that we are having great difficulty coding the different procedures or reasons for visits. And often these are non MDS that are performing therapeutic procedures. So it has really come to the surface more in this past year.
DR. IEZZONI: Okay. On that same topic, for any of you, on the issue of medical devices and durable medical equipment, we have not really talked about the coding of that very much but a number of the speakers have brought that up, I guess in the VA and in HCFA as well in the HCPCS. And I guess the FDA as well. Obviously you have to think about coding of devices.
Did you look at a variety of different coding systems for coding devices and durable medical equipment, and do you have any comments about how well the system that you did choose works for you?
MS. HUNTLEY: I will start. One of the things that I think Vivian Coates later on this afternoon from ECRI will give you a much broader description of, again the FDA and our Center for Devices and Radiological Health does the regulation of such devices, many of the classification of such devices are actually a part of our regulations. As we are moving forward in the establishment and the reevaluation of the naming of devices, the coding of devices, things such as that, we are also participating in a group called the Global Harmonization Task Force. Again the idea in the fact that it is not just a national issue but our companies, in many cases, are multinational and what is called something in one country it would be very nice if we called it the same here, especially in clinical trials and things such as that.
ECRI has been instrumental in this group also and I know Vivian is going to give you a full explanation of that so I will not take all that part away.
DR. IEZZONI: How does that interface with the HCPCS RDME and device?
MS. HARRIS: There is probably relatively little relationship. One of the things that, I think it is hard because we are looking at things for altogether different purposes and at altogether different points in their cycle. One of the things that we do look at in terms of giving a code to equipment or advices is whether it has FDA approval. But then may look beneath that as an assist to tell us where to put it but that is probably only occasional and so it is really the threshold question of whether there is FDA approval.
You are asking me to go back over 15 years ago when we first were established in HCPCS to kind of recall what we found there and my recollection is that there were no other, well, lots of Medicare carriers and lots of Medicaid state agencies kind of had their own homegrown coding systems, but in terms of was there a coding system that we could adopt, no, there was not.
And then another serious limitation for us, and it was alluded, well, I guess two limitations for us, both that were alluded to earlier this morning, what payers like to do is to group like things together and so we want to find all of the braces, all of the back braces that do the same thing and group them together into a generic terminology for a back brace and then find a group of other back braces that do something else and lump them together into a generic descriptor that describes what those back braces do, which may or may not be consistent with FDA's needs.
And then the other thing is that we are limited to a five-digit coding system. That is what the standard is now for payers, that is what payers can accommodate. There is some discussion of moving to larger coding systems. There is discussion of that for doing coding for injectable drugs, for example. But you are faced with the tradeoff of the expense of moving to a larger, being able to handle a larger number of digits for a relatively few claims that are flowing through that particular claims processing system. You have probably gathered from the discussion here that prescription drug claims tend to move through one claims processing system. Dental claims tend to move through one claims processing system. Hospital claims tend to move through one and then these other ambulatory physician services and supplies tend to move through another.
MS. COLTIN: Jeff?
MR. BLAIR: This question is addressed to Kathy Huntley, wherever you are. Right in the middle? Hi, Kathy. Could you tell us a little bit more about the IMT, but specifically as background just the idea of pulling together an international medical terminology. I am wondering if in the process of doing that you learned anything that would be useful for the committee to know in terms of a way to expedite the development and coordination of clinical terminology?
MS. HUNTLEY: Actually I would be more than happy to tell you more than you ever asked. The others, I am also going to be, I am part of your data developer group after your break so I can get you now or I can get you later. But one of the main things, and I will tell you the rationale for it and then we can go over the terminology a little later, but the rationale for this whole was the fact that, one the FDA has to meet very, very stringent review practices and review time lines. You can only throw so many bodies at it and still get it done faster. You need to move to some standardization, you need to move to some sort of ability and I think HCFA and most of you have all already moved in that direction faster than we have.
The second is one of the things that we found out -- and I want to agree with Dr. Burt -- is we needed a hierarchy. We needed to be able to do epidemiology but also code separate clinical medical events.
We also needed to have the not otherwise specified. Very important for us. We get, we meaning regulators internationally, get reports that might be patient threw up on my shoe. And then we get very, very specific two paragraphs from a gastroenterologist describing this same event. So we have to be able to capture -- and we will stop there -- we have to be able to capture the level of specificity that can come from a consumer, a non health care professional and a medical professional and a medical specialist. So we needed to be able to capture all of that.
We also needed to be able to make sure that the same term does not mean something different in another country or in another language. An example is collapse. I regularly go home and collapse. But collapse in Germany and in France means full circulatory collapse. So, ambiguous terms such as that we had to remove from the international terminology or we had to specify.
So, some of the things that we have learned is that we have gotten in the United States validation from the medical specialists of each of the sections, got our buy-in and we made sure that they were comfortable to be able to see their type of practice represented properly, not by a group of internists or a dermatologist writing the ophthalmology section or things such as that.
We also needed for industry's purposes to make sure that they could do the epidemiology, the data display, the data collapsing. So we needed to make sure of the middle levels of the hierarchy.
And something that was very important to us is the fact, we have a very, very specific issue we are addressing. It is not 100 percent different from the issues everyone else is addressing but it is very focused. We have a very short time frame upon which to do this. We have multiple international, national and industry pressures to do it.
So we are addressing a need, that has been this international development, and what we are looking at trying to do is, and one of the things I did not address, was the maintenance. We need to make sure this international terminology is as inexpensive but properly maintained on an international basis as possible. We have one and two people, Ma and Pa companies that produce wheel chairs or very specific braces or things such as that. We cannot have a multi thousand dollar subscription fee to this thing.
So our approach on it, and I will explain later, is that this will be maintained, the international terminology will be maintained through a contract process. An international contract will be let. It will be signed and it will be monitored by an organization based out of Switzerland.
So that is how we are handling, so those are some of the lessons learned, we have [unintelligible]. It has to be inexpensive. It has to meet the needs of the users, in our case, and it has to be medically informatics and IT correct. So, you can get doctors to come up with great words but you either cannot do anything with them or you get people that can lump but there are specificities there and the IT cannot implement it. The IT people need to make sure it is medically correct. So that is how we, those are kind of the lessons learned we have done.
MS. COLTIN: Thanks. Other questions from the committee?
MR. SCANLON: Jean, you mentioned the number of coding classifications that HCFA uses. Were they required for use in Medicare and Medicaid or were they largely Medicare?
MS. HARRIS: We require, we have regulations requiring the Medicaid programs to use ICD-9 for diagnosis and CPT for procedures. I must confess I do not remember whether it requires ICD-9 in the inpatient setting or not. Our mechanism for doing that is, as those of you who work in the Department and are familiar with the Medicaid programs know, we provide special federal matching money for the state Medicaid programs to maintain an information system or a claims processing -- and meaning that a very broad system; it is broader than just pushing claims through -- but maintaining a system, a Medicaid Management Information System is the term for it, maintaining a systems that meets federal standards. So we made that a federal standard and in order to get the enhanced match they had to use our ICD-9 and CPT and HCPCS.
Having said that let me say that because of the, some of the unique services that the Medicaid programs cover, again because of the types of people that they are covering and the fact that they are the payer of last resort and so on, they have some very unique needs that other payers do not have. Probably the best known and clearest example is they pay for none emergency, non medical transportation. That translates to taxi cabs and bus fares. So they do have a lot of very unique needs.
MS. COLTIN: Go ahead, Bill.
DR. BRAITHWAITE: We heard yesterday about the use of the NDC codes for drugs which are essentially generated by the manufacturers. And although some investigation is going on about some apparent irregularity in that that we need to hear about, I am wondering if there isn't something similar that is being done for devices and supplies that could supplant the multiple coding systems I hear about here for identifying those things for billing purposes?
MS. HARRIS: Again, I think that is part of what you are going to hear this afternoon. That is part of that global harmonization and the ECRI/FDA work.
DR. BRAITHWAITE: Okay.
MR. PRACEK: I can give you a P.S. on that. I am a co-chair of a NIDR subcommittee, National Institute on Disability and Rehab Research and we had a report two months ago about a classification system for assistive technologies that has been completed as part of a NIDRR contract with an RTI, Research Triangle Institute, contractor. I do not know the number of codes but let's put it at somewhere around 1,000.
So it is a developed classification system for assistive technologies and devices. So, it is there and it is ready for use. I am not sure it has been tested in any empirical way but it is based on an inventory of all of those lists and inventories of devices and then they tried to put it together in a meaningful way. It is not a WHO system and it is not ICD-based.
DR. BRAITHWAITE: It sounds like a super list of classifications. What I was thinking more about is something like the NDC code which is manufacturer-assigned, extremely specific to the individual device or product, like when you, and bar coded like when you go buy something at Safeway. You buy your cough syrup, you run it past a scanner and the scanner knows exactly what that product is and then, of course, the company can decide what to bill for it.
It does not seem to make much sense to me to have the FDA and HCFA and God knows who else, forcing providers to recode that into things so that they can avoid doing the manual classification that we once had to do. Now that that is all done by computers it does not make any sense to me anymore. Any comment from either HCFA or FDA about that?
MS. HARRIS: I do not know enough about the field to be able to answer your question. I have heard other people make essentially that same argument but I just do not know any more factual detail than that to be able to respond to it.
MS. HUNTLEY: I was just going to say I know some of the ongoing work that is going, that is currently occurring. There are people from our Center of Devices that are actually participating and, again, hoping not to have the duplication.
DR. BRAITHWAITE: Yes, the only thing I can imagine the problem with the FDA is that you have to regulate the device before it is assigned that number as a saleable product. But maybe you could work something out so the number is assigned by the manufacturer before it, you know, while it is being reviewed or something and use it throughout the lifetime of the product.
MS. HUNTLEY: At least there is some sort of consistency as it moves forward.
MS. COLTIN: Okay, Lisa?
DR. IEZZONI: Jim, I know that AHCPR did a coding validation study looking at clinical definitions of codes and looking at the accuracy of assignment. And I just wondered whether you could summarize what the results of that were and whether you learned anything from that study that could inform us as we move to ICD-10-CM or think about the diagnostic classification system?
MR. SUMME: I, Kathy is, Kathy Weiss is here. Maybe -- I defer to Kathy.
DR. WEISS: We did notice, we reabstracted 27,124 medical records of Medicare patients that the hospitals voluntarily sent to us. They were very nice to do that. And I am moving 522 boxes of them tomorrow because I was told to move again in our agency. I need a warehouse. But in looking at these in bits and pieces we got, we had a team of coders come in under contract to reabstract as many diagnosis codes and procedure codes. We limited it to invasive diagnostic tests and expensive therapeutic tests -- MRIs and that stuff. We did not include venopunctures and those type CPT codes. And we also linked the Part A bills with the Part B bills and then we had our reabstracted codes.
And we are having a big problem. We took one great big leap step forward to try to do the study and we have been backpedaling since because we have gotten blocks of CPT codes that are blocking up against the ICD-9 procedure codes. And you sit there and try to figure out, you know, the hospital codes it open reduction, internal fixation. The physician's bill came in closed reduction, internal fixation. They send me back in a room and I crawl on the floor, pop up and find a box where a record is that has one of those and pull it out and I am sitting there and reading the whole thing and find out somewhere in the middle of the progress notes -- and the average size of a medical record back in fiscal year 1995 is 120 pages -- and I find out, you know, reading the thing, the physician coded it wrong and the hospital had it coded right.
So then we set out our little mini study to try to figure out how many times that happens. Is this, you know, random error, systematic random error? And half of the time we find the hospital has it coded right and the physician has it coded wrong even though the physician is doing the procedure. And the physician may have it coded right and the hospital has it coded right.
So, in a sense, you know, it is even hard when you are matching up, you know, bills from the provider with the facility bill to get a one-to-one correspondence to figure out what is going on.
We had up to 40 diagnosis codes and up to 40 procedures coded out of each record. On average I believe the number for diagnosis codes was something about 9 and the average number for procedure codes if you coded everything that was worthwhile to be coded on procedures, would be about, I think, 4 or 5, not more codes than that. And I think that that sort of confirms a study they did out in California with their hospital discharge data set.
So, if you have the problem like Jim mentioned of this one-to-one correspondence, you also have the problem of incompleteness of codes. Specifically, our coders coded CABGs. There was no code, and this time there were five diagnosis, three procedure codes to be sent in to HCFA, no CABG code on the HCFA files. And I am sitting there going, oh my god, that is a high paying procedure, what is going on. Did we hire a bunch of bored people to code for us?
So they sent me back off to the records rooms again with the boxes and I am crawling around again with my staff and pulling out all the CABGs we had on site. Because we have 1,800 boxes stuck somewhere else. We only kept a small sample, 522 boxes. So, because of the problem with the fiscal use of the codes the hospital had an incentive to code a valve job. Say it was a mitral valve replacement. DRG104, if you have a cardiac cath; DRG105 without a cardiac cath. A CABG is a DRG106 with a cardiac cath. They had a valve job.
So, you know, the financial inventive was to code that valve job to get your highest paying DRG, qualify it with a cardiac cath, forget about the CABG, you know. And it has taken a lot of time to go back and forth and run in these rooms every time -- because they move our records from building to building at times and I am chasing them -- but to go in and pull the records out and realize, you know, this is why I have information missing.
When you looked at the medical records you could sit there and see a CABG was done and for looking at, use it, trying to look in an efficient way to look at quality of care, admittedly you are not going to be able to do complete outcomes unless you are looking at mortality or something like that, but to identify a sample frame. To try to get an idea of quality of care, access to care, completeness of care. If major procedures were done there ought to be some encouragement to code those regardless of the fiscal payment for that.
So, even for a sampling frame you have a problem. Then what do we do if we wanted to pull out all CABGs, you know? We do not know because you have the problem of the codes mapping to financial payment. That is where it starts. As soon as you hit the highest payment, the game is over, fold up the book, go home.
There is also the problem in smaller hospitals, because we have, you know, very small hospitals in the study, whereas there may be other diagnoses there but naturally they have very little incentive, the smaller hospitals, because they are less automated.
They have two coders at the most time in these small hospitals, 200 beds or less. You have two people in this little sweat shop and a lot of times they are coding out of a hardback book. And, you know, as soon as they get whatever is going to be there that is all you are going to have filled in.
Plus the fact that for continuity of care a lot of these people in the rural areas have the same doctors. You know, their co-morbidities and, you know, their other conditions are kept up in their head. They do not code it every time they go in the hospital.
So to get a complete clinical picture of the patient is 1, very problematic because of the intertwining of clinical coding with payment. And then to get a picture of what happened in the hospital clinically is very difficult because of that intertwining also because you hit the highest paying and then you stop there.
So we have had a lot of problems in trying to move through this study. We actually went back a couple months ago and we had another 400 records recoded altogether so we can have another little sample to compare to see who is right on these.
So, you know, from a research perspective, and I would think from a payer's perspective to know what the heck you are paying for, you have to know what was done to that patient and what was all taken into consideration from a clinical perspective. Not only are you taking care of the patient with CHF but the diabetes may have complicated that. You know, they may have had other clinical problems that clinically you are thinking through when you are taking care of this patient in a hospital but none of that shows up. And that affects how long a patient is in the hospital, you know, where they might have been positioned in the hospital, you know, and things like that. And none of that information is conveyed.
So, you know, I think there is a big problem with using numerous coding systems. We just cannot map them. The ICD-9, CPTs, we are having a big problem and we cannot even figure out why these people were in the hospital.
MS. COLTIN: Okay, Jeff, do you have a follow-up?
MR. BLAIR: Yes, short of the dream we all share for a computer-based patient record, in the nearer term, what suggestions or recommendations do you have that may not be a complete fix but might be a good value proposition to improve things?
DR. WEISS: I know people have proprietary interests in the various coding system they developed, and I fully understand the costs of switching over, you know, from departments to different coding systems. But we are never going to be able to look at what we are spending in health care and whether we are getting value for our money unless we are all analyzing the same information and can compare it. To me somehow that leads us to a single coding system and then teaching people how to use it.
The administrative data, also, as Jim mentioned, is very problematic. In the office, place of service, well, when the bill goes out from the physician the woman in the physician's office or man in the physician's office filling out bills, they are sitting in the office. Where is the service? In the office. The doctor really went to the hospital to do that heart transplant. You are not doing them in your office but you have place of service, physician's office down there.
There needs to be a lot more training so that we get quality data for the data that is coded. We have problems with the data that is even coded for payment purposes. I think a single coding system, and I realize that has a lot of problems --
MR. BLAIR: How do you envision that a single coding system is something we could achieve in a short period of time, in the next year or two or three?
DR. WEISS: I mean, you have an ICD-9 diagnosis code and procedure code. Admittedly the ICD procedure code is more aggregated than the CPT code. You know, I guess for research purposes, Lisa might have her preferences, you might prefer the more disaggregated codes. Somehow you would have the hospital then billing with CPT codes instead of ICD-9 codes so you could get that additional information. You just have to, people are going to be burdened.
You have to pick a system that will provide you the level of information that you need to answer the question you are asking. And if it is looking at something other than payment, which claims are being used for, you need something that conveys a lot more information in the future maybe than the codes we have now. Even looking at a computerized patient medical record -- I just want to make this one last comment -- you can get the clinical value for the lab test or whatever you are looking at, but unless you figure out how to standardize that across hospitals or collect an extra field to indicate whether it is at a normal, abnormal value or put the ranges in there for that hospital, you still have no comparability even though you have collected all that clinical information.
So you have wasted a lot of time and money getting that in because you can only look at it within that one facility because they bench mark their, they test their machines at a different calibration every one. So, you know, a lot of these things need to be thought through.
I do not have answers, but if I had a single coding system whichever it was, even if it wasn't as disaggregated as I would like it as a researcher I could be comparing apples to apples, as we say, and if it was complete I would know everything that was done to a patient so I would at least have a sampling frame.
Right now I would have no idea what is going on in the health care system and what people are getting and really, what it is costing. I do not think you could really figure out what it costs for any of us to be in a hospital.
MS. COLTIN: Other questions? On that discouraging note.
[Laughter.]
DR. WEISS: They only threw me in here to create your [unintelligible].
MR. SCANLON: Just one question, I think, to Kathy. You talked Kathy about these new drug applications that are delivered in trucks. Is, and number 1, the FDA does have an initiative for electronic drug applications, I think, but why are they so voluminous? Are there individual patient, clinical level records that are then rereviewed by FDA reviewers?
MS. HUNTLEY: Well, what it is, I mean, the trucks is not, is really not at all a joke. It is very depressing when they drive down the street.
[Laughter.]
And we all guess who is going to get it.
[Laughter.]
But there are things, for example, I mean in some products you can have 15,000 to 20,000 patients studied for 15 to 30 different indications for an antibiotic. And in many cases we do not have summary data like Europe does. We do get the individual case report forms. So we do review that. In a lot of cases, that is one of the things, for example, in the FDA reform issues, is do we need that? In some cases I think the answer is yes and obviously, in some cases, no. What we are trying to do is look at the happy medium. But they are to document every use of that product from the beginning of the investigation, the phase I, you know, healthy five foot ten, 170 pound people that they found, you know, that lived through it to the phase II and the phase IIIs. And in many cases the phase IVs, also, all international trials. You know, is this product marketed somewhere else? Where is all that marketing data, the safety information?
Now, also in that is not just clinical. It is every, you know, fruit fly through beagle that got this product and what happened to them and the evaluations. God forbid, I would probably get killed if I was at work saying all this.
[Laughter.]
And also all the chemistry, all the manufacturing. So all of those volumes is the complete production, chemical testing, pharmacologic testing and clinical testing of that product from inception to the marketing application. So it is a massive amount of information.
MR. SCANLON: But it is often that the case records rather than the --
MS. HUNTLEY: And three copies of everything. One goes actually in the FDA's archive which is held forever and ever and one is something that is distributed amongst all the different review teams. The chemistry obviously goes through chemists and things such as that. And one is the copy that stays in for the, we call it the document control room, for anybody within the Agency to have access to if we need comparative studies across centers and things such as that. So there are three copies of all of it.
MR. SCANLON: I understand why trucks are needed.
MS. HUNTLEY(?): [Comment is off microphone.]
MR. SCANLON: That is why the Percalon(?) Building was built.
[Laughter.]
MS. COLTIN: We have a question in the audience? Can you come to the microphone, please.
MS. SEARE: Hi, Susan Seare. I am from Medicode(?). To some of Nancy's comments. We collect hundreds of millions of claims data records every year and one of the things that we are finding as we are trying to map the CPT code services, ambulatory to inpatient hospital services, is that just eliminating the administrative errors in the enrollment part of a claim form we have about a 30 percent error rate against the editing systems in CPT coding, slightly less than that in hospital coding. But the aggregate when you try to map it is upwards of 50 percent. And that is data that we have to throw away, that we cannot use in any analysis because we cannot map it.
MS. COLTIN: Just to make it a little more discouraging. Thank you. Lisa?
DR. IEZZONI: Jean, HCFA has a number of other really interesting data sets, such as the Minimum Data Set, which is collected on nursing home patients, and I guess you just had a rule that came out to test a new system for home health care which is called OASIS. Do you have any experience with those data sets in the context of trying to look at patients longitudinally as they move from an inpatient setting where they might have ICD-9-CM codes and then looking at them as they go into a nursing home where what they have is a minimum data set. And if there is any diagnostic coding in nursing homes that allows you to kind of track them or how the MDS fits with the coding that you would see from the hospital?
MS. HARRIS: I do not know the answer to those questions.
DR. IEZZONI: Okay.
MS. GRAHAM: The MDS code includes ICD-9 codes in most cases.
DR. IEZZONI: It does? Okay.
MS. GRAHAM: In addition to codes that describe toileting and ADLs and all of that, it is also --
DR. IEZZONI: But those are not ICD-9-CM codes, the codes that describe toileting and --
MS. GRAHAM: No, those are just fields within the form that indicate the levels of the codes(?).
DR. IEZZONI: So there is no coding of those. They are just data fields on those forms --
MS. GRAHAM: Correct.
MR. MOORE: Along that same line we have an initiative that we are working with HL7 to make sure that that information that is in the Minimum Data Set is also going to be included in the clinical data that they would be working on in any clinical activity for a clinical record. And we are working with X12 in that when that information is moved from the nursing home to the public health where it would be reviewed, we would be using an X12 envelope for that movement. So we are trying to work within the standard development organizations to make sure it is in the record or going to be part of the record as they move in that direction and that it can be transported using something that is going to be used for all the other standards.
DR. IEZZONI: Great.
DR. WEISS: Lisa, if I may, we use the MDS on looking at the cost analysis for one of our clinical guidelines in the Agency. And when you go from the hospital to the nursing home [unintelligible] since basically that is what you are paying for, the same ICD-9 codes that you had inpatient follow you outpatient and they stay there. The Minimum Data Set just adds a lot of information on IADLs, functional status and your general health status which is not coded in any way. They have numbers in fields. You can use the data but your ICD-9, and occasionally there is even procedure codes if they send them back into the hospital.
DR. IEZZONI: And do nursing homes use ICD-9-CM for procedure coding?
DR. WEISS: Yes.
DR. IEZZONI: Okay.
MS. COLTIN: Other questions?
[No response.]
MS. COLTIN: Okay, thank you all very much. We are going to take just a five minute break while they set up the microphones for the next panel. So, five minutes and we will be strict about it.
[Brief recess.]
MS. COLTIN: This is the panel on Developers of Coding and Classification Systems. Because we are running ahead of schedule it may be necessary, occasionally, to take presenters out of order if people are not here yet. But we are going to begin following the order in the agenda. So the first speaker would be Marge Zernott. Okay, and before you begin, each person please introduce yourself and the organization you are affiliated with. Thank you.
Marge Zernott, ZKC Associates.
MS. ZERNOTT: My name is Marjorie Zernott and I do not represent 40,000 psychoanalysts --
[Laughter.]
I do not represent 150,000 medical coders but, and actually most of what I was prepared to say today has already been said. So, since I have lived and worked through three changes in classifications, I thought I might give a little historical perspective on what you have to do to do it.
First of all, there is going to be a lot of weeping and wailing and gnashing of teeth and prophecies of doom but sooner or later everybody is going to sit down and do it. I have very little patient with people who are worried about the year 2000. We knew 100 years ago that we were going --
[Laughter.]
I cannot figure out why all of a sudden it is a big emergency. And, in fact, they even knew 15 years ago that they were going to get a new classification, too. They did not think it would come quite so soon, but it is here.
When we did, when we went from ICD-8 to ICD-9 we did it in two years. We went from hospital to hospital with foot lockers full of coding manuals because none of the hospitals had any so we had to bring our own and went to teach them. And you could never go back to the same place twice because none of the porters would pick up your foot locker for you the second time.
[Laughter.]
But we managed to get it done. It was not easy and a lot of people, a lot of people stayed behind. For instance the whole state of Michigan stayed behind for a year at least, stayed with ICD-8 without going to ICD-9. And I think you are probably going to find that happening again, that some people will be prepared and some people will not.
And a lot of the beginning part is going to be just translations using crosswalks. And I think that is alright. I think that way you get rid of some of the problems that you will inevitably find.
I would like to recommend several things. First of all, the thing that took us the longest when we went to ICD-9 was trying to figure out who was going to do what. And have everybody come to the consensus about who was responsible for what. Who was going to write the educational materials?
The reason I say that everybody has said what I planned to say, I planned to sit here and do some cheerleading for ICD-10-CM but it seems to me that everybody is pretty much on the bandwagon already, and very few dissenters. So I think that now is the time that you have to start thinking about writing educational materials which will be really fairly easy because they just have to be updated from the ICD-9-CM materials.
There are very few major differences. I have been involved in writing the crosswalks and there are very few major differences. There are major differences in the injury chapter because the access(?) of classification has changed but there are really very few major differences and as several people have said, the coordination and maintenance committee has already put into ICD-9 a lot of the things that appear in ICD-10 and vice versa, actually. So that is the first thing that has to be done, is the educational materials have to do it.
Also, I would like this time if somebody would take responsibility for writing software to audit accuracy of coding. There is no reason why that cannot be done. You take patients in groups. You can write software that will say this particular set of data is unusable for any kind of research. And then get back and try to teach, target your teaching.
Also, one thing that we tried to recommend when we introduced ICD-9 was the idea of some kind of a secretariat to be in charge of coding. It seems to me that, for instance, you are interested in more specific coding of congenital anomalies why don't you get together with the M- NACRI(?) and use their congenital anomaly classification? And the reason you do not get together with NACRI and use their congenital anomaly classification is because you do not know about it.
There needs to be some kind of a clearing house that collects data on all of the different classifications that Mom and Pop people are putting together and, if possible, get them not to do it, if it has already been done. That is the little problem, but it could be done.
And also, that is the biggest thing is the accuracy of the data. All of the people that have complained about having inaccurate data, I do not know what the answer is. You can say it is more education but I do not know if that will help. And Kathy Weiss was absolutely on target when she said that as soon as they get the best pay they stop coding. So unless you use the data for other things such as quality assurance and you let the people who are putting the data in know that you are using it for quality assurance.
We used to say years ago when we first had our health, our discharge data abstract system that the first thing that happened when a hospital signed on to PAS was that the data got better because if people are cognizant of the fact that somebody is going to look at it, otherwise you just sat and put codes on 3x5 cards all afternoon and nobody ever looked at it again. And so as soon as you had people looking at reports the data got better. And that, I guess something like that is going to have to be done. Somebody is going to have to take interest in the data for things other than reimbursement before the data gets any better.
MS. COLTIN: Thank you. The next speaker is Donna Pickett.
Donna Pickett, NCHS
MS. PICKETT: Ms. Coltin, members of the subcommittee on Health Data Needs, Standards and Security, my name is Donna Pickett. I am the medical classification administrator at the National Center for Health Statistics. It is my pleasure to appear this afternoon to present our perspectives on medical clinical coding and classification. My statement summarizes NCHS's ongoing activities as they relate to ICD-9-CM, the clinical modification of ICD-10 and to administrative simplification addressed in PL 104-191. NCHS is the WHO collaborating center for the classification of diseases for North America and for the International Classification of Impairments, Disabilities and Handicaps. It is responsible for the coordination of all official disease classification activities in the United States relating to the use of ICD, its interpretation and periodic revision. The ICD is the core of the family of WHO classifications which includes ICIDH, ICDO-2 and various specialty adaptations of ICD.
First I think it would be helpful to understand that ICD was developed for international statistical classification. It was intended for many purposes in many countries at greatly different stages of economic development. The ICD is expected to serve a range of purposes but at the extremes of advance computer users and unsophisticated manual systems it will not meet all of the requirements. It was never intended to describe all medical conditions. The ICD's principle use is as a tool to report and record morbidity and mortality statistics which it does by grouping diseases into categories. Its primary concern is not the name that should be assigned to a disease but the category under which the disease should be recorded.
This purpose contrasts to the needs of a nomenclature such as the International Nomenclature of Diseases which is designed to recommend descriptive name for diseases without attempting to group the conditions for statistical reporting. Since 1979 the U.S. has used the ICD-9-CM which is adapted from ICD-9 through extensive modifications, including the use of fifth digit subclassifications. The structure of the clinical modification revisions permits statistics reported in ICD-9- CM to be collapsed back to ICD-9 for comparability between mortality and morbidity statistics.
ICD-9-CM has been adopted by the Federal Government and the private sector for a number of purposes, including statistical reporting, data collection, quality of care analyses, resource utilization, research and yes, reimbursement. Since 1985 the ICD-9-CM has been updated on an annual basis to accommodate changes in medical technology and the need to provide greater specificity in classifying, diagnoses and external causes of injury. Requests for modification are handled through ICD-9-CM Coordination and Maintenance Committee. This committee co-chaired by the National Center for Health Statistics and the Health Care Financing Administration was formed to provide a public forum to discuss possible updates and revisions to ICD-9-CM. The committee has discussed such topics as the need to update ICD-9-CM due to changes that have occurred in the health care field over the last several years since ICD-9-CM was first implemented. No official changes are made without bring brought before this committee.
Although the committee is a federal committee, suggestions for modification come from both the public and private sectors and interested parties are asked to submit recommendations for modification prior to a scheduled meeting. Modifications are not considered without the expert advice of clinicians, epidemiologists and nosologists, both in the public, and again, in the private sector. The meetings are open to the public, are announced in the Federal Register, and all interested members of the public are invited to attend and submit written comments. Summaries of the meetings are disseminated widely to a mailing list consisting of more than 600 individuals and organizations and are published in several health information management focus journals including the Journal of the American Health Information Management Association.
Coordination and Maintenance Committee process ensures stability of the classification and its comparability with its parent ICD-9. The update and modification process has also been favorably reviewed by the WHO as a mechanism to update ICD-10 between major revisions.
While ICD-9-CM has evolved considerably since 1979, it is now stretched beyond its intended purposes and is nearing the end of its capacity for responding to additional classification specificity, newly identified disease entities and other advances. There are a few spaces left in ICD-9-CM for code expansion to enhance clinical detail.
This is one of the reasons that the National Committee on Vital and Health Statistics in 1993 recommended that the Department immediately commit resources to assess the applicability of ICD-10 for coding morbidity, to identify problem areas and make modifications as necessary and to develop implementation plans. The subcommittee on Medical Classification Systems initiated a letter from NCVHS to the Assistant Secretary for Health and the Administrator of the Health Care Financing Administration recommending that the Department dedicate resources to determine the feasibility of implementing ICD-10 for morbidity applications in the United States.
In September, 1994 NCHS awarded a contract to the Center for Health Policy Studies to evaluate ICD-10 focusing on the suitability of ICD-10 as a statistical classification for morbidity reporting, specifically emphasizing comparisons with ICD-9-CM. The initial purpose of this comprehensive evaluation was to verify whether ICD-10 was a significant enough improvement over ICD-9-CM to warrant its implementation for morbidity reporting in the United States.
Secondly, to develop recommendations to improve ICD-10 and to correct any problems identified during the course of the evaluation. And lastly, develop a revised index and crosswalk.
A technical advisory panel convened under the contract consisted of 20 members representing a broad cross section of the health care and coding community. Federal members included HCFA, various departments within NCHS and the Agency for Health Care Policy and Research, classification experts, hospital representatives and physician representatives. Considerable effort from a diverse group of knowledgeable classification experts was necessary to ensure that the results of the ICD-10 evaluation and the recommendations for clinical modification meet or exceed the high standards of previous revisions and adaptations and modifications.
Completion of the evaluation contract was scheduled for September, 1995 but because of the proposed modifications to the tabular portion were so extensive the contract was extended to allow time to incorporate the changes into the index. The contract also had to be extended due to the federal furloughs.
ICD-10 as published by WHO has greatly expanded since it was first implemented for mortality reporting. ICD-10 as published by WHO contains 2,033 categories, 855 more than were contained in ICD-9, with decimal subdivisions that equal the total code number now being 12,420.
ICD-10 includes significant improvements including primary care encounters, external causes of injury, mental disorders, neoplasms and preventive health. New categories at the end of chapters have been added for post-procedural disorders and there are more codes to describe in detail socioeconomic, family relationships, ambulatory care conditions and problems related to lifestyle.
As of October, 1996, WHO has authorized the publication of ICD-10 in 37 languages with 28 countries having implemented ICD-10 for morbidity and mortality applications. The remainder of the countries are expected to implement ICD-10 on or before the year 2000.
The original development of ICD-10 was an open process in which there was a deliberate effort to involve(?) all organized medical specialty groups. The technical advisory committee convened under the contract and conducting the U.S. evaluation recognized the many advantages of ICD-10 structure over ICD-9-CM but were also cognizant of some deficiencies as a morbidity classification. These deficiencies included the continued use of the dagger(?) asterisk convention. This convention was modified in 9-CM by introducing combination codes and was never introduced in ICD-9-CM.
They also found the need to return to the level of specificity implemented in ICD-9-CM and the need to facilitate alphabetic index use to assign codes. Also there were modifications to titles and language in ICD-10 that were more in keeping with clinical practice in the United States.
The TAC concluded that there were compelling reasons for recommending an improved clinical modification version of ICD-10 which would overcome most of the limitations. Therefore the TAC strongly recommended that NCHS proceed with implementation of the revised version as soon as possible stating that ICD-10-CM represents a significant improvement in the clinical specificity, ease of use and accessibility over the ICD-10 and ICD-9-CM. Hence they made the strongest possible recommendation that the ICD-10-CM tabular list and alphabetic index be adopted and implemented as the standard U.S. classification as soon as possible.
The clinical modification of ICD-10 provides additional classification detail and includes logical restructuring in the relative placement of certain entities. Further ICD-10-CM remedies many cumbersome classification dilemmas that have impaired ICD-9-CM.
Following the receipt of the final report in March, 1996, NCH staff began further evaluation of the draft of 10-CM developed under the contract. This second phase of NCHS review builds upon the completed evaluation study and on the recommendations that were incorporated into the draft of 10-CM.
The focus reviews have concentrated on the following areas: the evaluation of residual categories, other, to determine whether further specificity is needed; further evaluation of ICD-9-CM expansions that may not have achieved the desired effect or may require revision because of new data needs. Specifically diabetes was one of the areas that we are looking at due to a need to possibly split out type II diabetes for insulin-requiring and non insulin.
Review of the previous several years of Coordination and Maintenance Committee recommendations were also compiled to review those recommendations that were made for updates and modifications to 9-CM that could not be accommodated due to space limitations. And lastly, further evaluation of ICD-10 categories that may not have the desired specificity to provide information for ambulatory and managed care encounters and outcomes research.
During this second phase of modifications we have worked closely with specialty societies to ensure clinical utility. We have held discussions and meetings and received comments from a number of medical/clinical specialty groups and organizations. To date we have worked with the American Academy of Pediatrics, the American Academy of Neurology, the American College of Obstetricians and Gynecologists, the American Urological Association, NACRI, The Burn Association, the National Center for Injury Prevention and Control, the Academy of Dermatology, the CDC diabetes program and the VA's national diabetes program to discuss specific concerns or perceived unmet clinical needs encountered with 10-CM.
We have also had preliminary discussions with other users of the classification, specifically nursing, rehab, primary care providers, NCQA, the low-term care, home health care and managed care organizations to solicit their comments about the classification. Once this specialty focus phase has been completed we will work with medical groups and organizations such as the AMA, the American College of Physicians, AHIMA and others, and AHA who have a broader-based constituency. Based on the work to date, we are confident that 10-CM is well positioned to replace 9-CM and will provide the necessary data needed for statistical reporting as well as for administrative transactions and some clinical information as well.
An important thing that has come up during the last two days of testimony is regarding coding guidelines. Coding guidelines should be an inherent part of any standard. Without guidelines the standard is not implementable. Once a standard has been approved there must be a mandate for all users to adhere to the official coding and reporting guidelines. Even though official guidelines currently exist for ICD-9-CM there are still payers who have created their own coding rules, primarily based on coverage and reimbursement decisions which are in direct conflict to official coding guidelines.
Unfortunately, the vagaries of insurance coverage, different payment rules and system edits have led some to feel that any code will do so long as it passes a screen and allows the patient to receive needed care or gets the bill paid in a timely manner. The assignment of codes should be based on the patient's diagnosis and/or reason for encounter and the services provided.
Payers should find alternative mechanisms to make reimbursement decisions, not by developing inappropriate edits that invalidate appropriate codes. The provider should be able to report what has actually occurred and not corrupt their records and data bases based upon what the payer is willing to pay or accept.
Clearly having one standard with one set of official rules would result in less administrative burden in a number of areas including reduction in programming expenses, not to mention the headache factor of trying to remember which rule you are applying for which payer depending on which claim. And to improve comparative data for better medical care, research and quality improvements and reduce errors in code assignment and possible misinterpretation.
Some have expressed a concern that the cost of implementation greatly outweighs the advantages gained from implementing 10-CM including the expense of converting computerized information and reporting systems. The structure and conventions in ICD-10-CM are similar to those found in ICD-9-CM as Marge Zernott just indicated.
Therefore anyone who is familiar with ICD-9-CM will be able to move to 10-CM without a major retraining effort. It is true that the alphanumeric structure of 10 will require modifications, however there is no way to avoid the cost of developing new edits and other support packages. However we feel that the added specificity, the improvements in logical consistency, the enhanced ease of coding should more than offset the conversion costs. Moreover, adoption of ICD-10 will immediately reduce costs incurred in accommodating the large volume of changes currently required for annual updates to ICD-9-CM.
The availability of educational materials, training programs and a 24-month lead time prior to implementation we believe will soften the disruptive impact of implementing ICD-10-CM. Furthermore, when we went from ICDA-8 and HICDA-2 we were all basically working in a totally paper environment. Marge talks about the truckloads of manuals and things that were charted around. In this new age of electronic media I would think that with the help of many groups we would be able to disseminate the information using CD ROM, video teleconferencing and other media that would facilitate the transition to 10-CM and not make it quite as disruptive and quite as labor intensive as it occurred in the transition to 9-CM.
NCHS has plans to make crosswalks available to 9- CM and 10-CM and is being conducted now as we speak under contract. We also have plans to offer ICD-10-CM in electronic formats in addition to the traditional book format.
Although some have stated a preference to continue to update 9-CM and defer implementation of 10-CM for morbidity reporting, such a decision would make national and international comparisons and aggregations difficult, as would the implementation of any other standard. This is particularly true since parts of ICD-10 have already been implemented. You have already heard DSM(?), the Psychiatric Association refer to how they worked with WHO in the mental health chapter and also what work they have done with us in the development of 10-CM. Chapter 2 of ICD-10 is very comparable to ICDO-2 which is currently in use in cancer registry programs, I believe since 1995.
The U.S. implementation of ICD-10 in 1999 for mortality reporting would introduce cumbersome processes for maintaining comparability between mortality and morbidity statistics over time. Therefore, NCHS believes that the continued use of 9-CM for administrative transactions beyond the year 2000 is ill advised. The ability to update 9-CM beyond the year 2000 is extremely limited and may eventually lead to the loss of important information. Further, for federal agencies and other organizations who are already engaged in international collaborative efforts it would also add burden to their programs in trying to meet the needs of two systems.
Many in the U.S. have awaited the implementation of 10-CM and have questioned why our implementation has lagged behind those of other countries. If more granular political vocabularies are recommended for the computer- based patient record there still will be a need to map this system to ICD to allow them to be comparable with national and international morbidity and mortality statistics. It should be noted that in the United Kingdom where READ CODES(?), a system that enables the capture and retrieval of patient information in natural clinical language within computer systems, was developed and widely used the ICD-10 is still used for administrative systems including vital and health statistics, contracting and reimbursement. So, yes, indeed, it can be done.
I would like to thank you for this opportunity to present our perspectives and would welcome any questions.
MS. COLTIN: Okay, thank you. Has Pat Brooks arrived yet?
PARTICIPANT: Pat will not be here today. She is ill.
MS. COLTIN: All right. So we will not be having anyone speaking on ICD-10-PCS?
PARTICIPANT: The one we have had all the questions about.
[Laughter.]
MS. COLTIN: All right. Then we will move to the next presenter. That is Kathy Huntley again.
Kathy Huntley, FDA
MS. HUNTLEY: Since Jeff already asked a question my presentation will be very, very short. Anyway, what I wanted to do is just very briefly talk about some of the activities going on in the FDA in the standards development. One is the National Drug Code which many of you know and love. One is the Medical Device Code which I am going to turn to Vivian Coates of ECRI and she can give you the description of the work going on with ECRI and our Center for Devices. One is COSTART, which many of you may or may not know, and then the International Medical Terminology.
The FDA's National Drug Code which is something that is obviously used by the administrative section, by the reimbursement section -- it is also used by the FDA for our regulatory actions and our recalls -- is actually a ten- digit number in three segments. It has been used since 1973. It is going, it is well received by industry. It is currently almost what I am going to call a maintenance-free type standard in the fact that it is a product identification that is moving along very well. Very well accepted.
One of the issues, again, that is coming to the forefront -- and I hate to keep banging my head against this one -- is the idea of the international application of such a standard. The NDC number is again used in the United States. The same drug company does not always market the same product in the same formulation, in the same size with the same name or even they may have licensed it, the same everything, but licensed it to someone else in another country.
One of the issues that is going to be addressed some time in the future of ICH, going to be addressed, maybe, it has come to the forefront multiple times by multiple parties, is the need for an international drug code enumeration. If someone gets a product from Canada or from Mexico or from Europe we need to be able to speak a common language.
The WHO's drug listing right now is a reactive listing meaning if they have had an adverse event or if there has been an issue they then start the classification and the coding of that information. They do not get regular updates on products that have been newly marketed in the various countries. So that is a reactive code but it is something that is, obviously there is pretty much only two out there in the wind that we need to review.
Now, I have talked real fast about the terminology, the International Medical Terminology. Let me just go real quickly over COSTART which, again, some of you may have heard of. It is the FDA's coding symbols for adverse reaction terminology. It was developed in the late 1950's, early 1960's with the collaboration of WHO. There used to be one terminology. It was called DART. D, A, R, T. What happened then is WHO Drug Monitoring Center moved to Solace, Sweden and then we started the bifurcation. So COSTART kind of went one way. WHOART kind of went the other way and again, we are at that 85 percent, the same 15 percent difference.
The FDA Center for Drug Evaluation and Research currently maintains COSTART. We currently, it is available at a cost, what it costs for(?) replenishing. I think it is $35, things such as that. It is the one that most of our industry uses. It is not a requirement to the FDA to report into it, so even if you do code your adverse events into COSTART we at the FDA recode them.
The reason we recode them, which is a horrible shock to most people, is the fact that the terminology is very, very general. The groupings are very large. What we need is consistency in placing adverse events into a very non granular terminology. It may be right, it may be wrong, but it is consistent.
We use it as an indexer so that we can go back to the reports, review the reports and do the epidemiology. The idea of somebody, you know, one company doing it one way, another company doing it another is not wrong but it is not consistent. So we do recode. That is one of the reasons that we are going to the International Medical Terminology.
There was an open public meeting on March 17 on our new adverse events system. It will be a requirement. It is going into the regulations that there will be pre- coded electronic submissions of post-marketing safety data to the FDA and it will use the International Medical Terminology. It will use the ICH electronic standards. And it will use those data elements that we have agreed internationally are needed for a safety evaluation. So this allows us to get out of the coding.
We are always going to have to code. As I showed you before, Dr. Kessler's MEDWATCH program is for any health professional. That can be faxed in. That can be called in. All of those, we will have to do coding and we know that.
We have also developed an autoencoder to help us, but what we are hoping to do is get out of the business of maintenance. We have not done a good job maintaining COSTART. We do not have dead bodies in the street. People know how to use it. We have gone on. But it is not something that the FDA wants to continue. We want to give that to an organization that does it properly and knows the appropriate way to do it. So, the COSTART will be replaced. We will be using the International Medical Terminology.
These were our guiding principles. You build from something that is there. You focus on international community needs, not just the United States, not just Europe. It has to have worldwide use. WHO has been at the table. I have presented it to WHO meetings regularly. The last one was in Portugal.
It has to have mechanisms for translation. We all do not speak English. This is not just a translation of the words. It has to be a medical translation. So it has to be validated by physicians for their practice of medicine in their country with the representation in their language. And it has to have long-term maintenance. This is something you all know.
As I showed you before, all the terminologies that everybody uses for everything. This is where we are leaning(?). We will use the IMT for pre and post-marketing from regulators and from industry. What we are doing is, and the reason that the ICH is so important, mostly to our regulated industry, is once there is an agreement under ICH the regulators will implement. So once we sign this document and once that it is agreed, the FDA is committed to implement the terminology. That is what drives industry to push and to finance the work under ICH.
What is in and what is out? Disease diagnosis, signs, symptoms, indications, investigations, surgical and medical procedures, medical, social, family history, WHOART, COSTART, ICD-9-CM, HARTS and J-ART(?). There are currently 300 terms in the International Medical Terminology that are in CONGI(?). We will not use them a whole lot. They cannot be translated into English. They have a very specific meaning that is not representable.
What is not in there? There are no drug product names. There are no numerical values for results. There are no severity descriptors. There are no device failure terms. It is literally the health effects that we are hoping to capture.
It is hierarchical. We started with version 1.0. We did a worldwide test of it. We went to version 1.5. We are now going to version 2. We, the United States, have rewritten 9 of these 26 system organ classes. The National Cancer Institute's Clinical Therapy Evaluation program rewrote the oncology section of this. They are also adopting it.
As you can see we spent a lot of time in the two grouping levels to do some of the work that we talked about, the last group, the Federal Data User's Group, and the fact of being able to aggregate and represent data. But we also should be able to represent the information. The preferred term is to represent a single medical concept, the lowest level terms are synonyms, lexical variants, colloquial(?) terms.
There should be no, I am saying should because, again, with terminology this size we are also, and I will say this up-front, we are shooting at the 80/20 rule. There will never be, in my humble opinion, 100 percent terminology. Until a terminology is out there, is used, is abused, is tested, that is why terminologies need to go in a maintenance mode. This is not an academic exercise. It is something we have been working very hard on in all of our regions getting buy-ins. I mean, Europe has all of the countries of the European Union to get buy-ins. The Japanese, God bless them, have been translating this moving target and getting it past their medical specialists. A
In the United States we have taken it out of ICH. We have gone to the device industry, the biologics, the bloods, the biotec, the pharmaceutical. We have gone to universities. We have gone to CDC. For example, they helped us redo the congenital and familial disorders section. We have had reviews by multiple government agencies and by multiple academics.
And, probably the most important is this should be voted on in July in Brussels. The terminology should be available worldwide hopefully by the end of this year, beginning of next. At that time our regulations will go out and we will begin using it internally within the FDA. Thank you.
MS. COLTIN: Okay, thank you. The next speaker is Dr. Harris.
T. Reginald Harris, M.D., AMA.
DR. HARRIS: Yes, Madame Chair and members of the subcommittee, my name is Reggie Harris. I practice internal medicine in Shelby, North Carolina and I am the chair of the America Medical Association's CPT Editorial Panel. I want to thank you for the opportunity to address this subcommittee. I understand you already have our complete written statement that includes answers to the questions you posed, and I know you had a lively and informative exchange yesterday with Dr. Kay Hanley. So in light of those two events I will try not to be repetitive but I do wish to highlight a few critical points for your consideration.
As Dr. Hanley stressed yesterday, it is the position of the AMA that the CPT system be recognized as one of the initial standards for administrative transactions as required by the Health Insurance Portability and Accountability Act of 1996. Such recognition is warranted for several reasons.
First, it is important for this committee to fully appreciate that physician's willingness and even ability to use a coding system, any coding system, is directly related to how meaningful the codes and descriptors are from a clinical standpoint. The words must be familiar. The phrasing of the descriptors must comply with the literature and the way we physicians speak to one another.
Also, as Dr. Cross noted this morning, we cannot escape the observation that a link to payment and medical review actually increases coding accuracy. Additionally the organizational codes must be consistent with the way that physicians are trained to take care of patients. If the coding system is not structured this way physicians simply cannot use it properly. And if they use a clinically inaccurate system because they are forced to do so, they are likely to use it incorrectly.
So, at the CPT Editorial Panel, one of our primary priorities is establishing codes and descriptors that reflect the real life practice circumstances of physicians. And by necessity, these may vary somewhat between different specialty areas. We feel very strongly that this is a significant strength of the system, one that has enabled CPT to be used so effectively in the administration of many public and private programs.
Next, I understand there has been some considerable discussion here about public/private partnerships in coding. Without any doubt CPT is the best working example of a public/private partnership that you can find anywhere. With representatives of the Federal Government, private payers, the hospital industry and now, other health professions, this group works very hard to find coding solutions that meet everyone's need to the greatest degree possible. There is a strong spirit of cooperation and of dedication of these individuals to maintaining a high quality system.
Our panel meets quarterly and works very hard at those meetings because in an average year we consider 250 or more coding proposals, on an annual basis that many proposals, and of that proposals that contains over 2,000 individual issues. So it is a hard working group of people and between the editorial panel and the advisors to the CPT process, this amounts to tens of thousands of hours of physician time that is volunteered for this process.
I believe that every one, all these individuals who participate in CPT believes it is fair and we are very proud of it. We are proud to be a part of that system. We have also worked very hard over the past few years to make greater opportunities for open input. We have direct input to the panel at each meeting and have been successful in bringing in all the specialties and other professions in that process and are actually trying to further expand to get greater public input into our process.
Third, I would like to address the speed at which the system changes. In maintenance of coding systems used for payment and administrative purposes like CPT two general groups can be identified. Some groups seem to want CPT to be updated almost monthly. On the other end of the spectrum are some payers who would like to see CPT updated about every ten years, if that often. And we have tried to strike a balance between some of those people and we update and publish the changes to CPT on an annual basis consistent with the Kassebaum/Kennedy requirements. It is our sense that this meets most people's needs and protects against establishing codes for procedures that have not been fully evaluated for safety and efficacy.
Now having said that, and while there are some down sides to doing so, we are open to developing a system for early release of newly developed CPT codes if all the logistics can be worked out. At the present time it is annually.
Fourth, I would like to make a few comments about the flexibility of CPT and its evolution. I think it is important for this committee to understand that CPT has developed in the way it has because the Editorial Panel is responsive to signals and directions we get from the users of CPT.
For example, on the issue of regularity or specificity, which I know this committee is most concerned about, CPT's current level of granularity exists largely because that is what we have been encouraged to do. The pressures for more specificity or code splitting, as we sometimes call it at the Editorial Panel, are often great. We spend a considerable amount of time in trying to manage the absolute number of codes in the system.
What I want to stress is there is nothing inherent in CPT or in its maintenance system that mandates this approach. We can easily expand greatly the number of codes in CPT, increasing the granularity in a significant way if the consensus of the users is that this is what we should do. Also, CPT can evolve to allow greater use of its codes to implement performance measurements for HEDIS, JCAHO and others who are interested in that area.
As you know, we maintain CPT under an agreement with HHS and we take that responsibility and, in particular, our relationship with HCFA, very seriously. We truly are partners in this process.
Lastly, and tied to my previous point, I want to leave you with a clear understanding that CPT has always evolved to meet the needs of the coding community. We are committed to doing so in the future. Madame Chairman, we are well aware of the criticisms you have heard, but without going into those in detail now, I would like to assure you that we believe they can all be addressed within the current maintenance process.
In conclusion, we do not want to initiate major changes in CPT or its maintenance process until this committee and the Department has completed their work on Kassebaum/Kennedy administrative simplification. We want to be certain that any changes we might consider are consistent with the long-term direction that this committee and HHS identify.
Thank you again for the opportunity to be here and I would be pleased to respond to any questions.
MS. COLTIN: Thank you, Dr. Harris. Okay, our next speaker is Bob Owens.
Robert Owens, ADA
MR. OWENS: Thank you Ms. Coltin and members of the subcommittee. My name is Bob Owens and I am the associate executive director of Information Technology for the American Dental Association, their CIO. Again, it is my pleasure to be up here before you today as a coding developer. We have, basically instead of reading verbatim the testimony again, I would like to just maybe bring out some of the highlights. You all have a copy of our written statement.
In regard to what classification systems or coding systems that we use today for administrative transactions, like we said yesterday we use CDT and HCPCS with the dental community and we use CPT and ICD for our oral surgery or medical claims related to dentistry.
As far encounter enrollment data they are not currently classified under dentistry at this time, and our experience with the transaction standards relative to enrollment does not even have any of these codes that we are talking about as a requirement in that transaction.
In regard to the second question, what do we recommend as the initial standards, here again I think it is important from our point of view that we look at this as really two distinct things that we are trying to implement. The initial implementation is for administrative simplification under K2, so from that standpoint we think for the reimbursement process CDT, CPT, HCPCS and ICD-9 are the codes to be implemented in this mission of regulation.
In regard to the need for clinical reporting, we have several efforts underway but that is separate from what we are looking at through administrative simplification. There are base levels of knowledge that you can gain through the claims process but again, keep in mind, most of the testimony that you have heard through the last two days has been from users of the data and not the paying community that actually needs the data for reimbursement. And when we talk about administrative simplification we are talking about the ability to report accurately the service performed for a patient in order to get reimbursement from a paying entity.
As far as our medical records, we are currently developing a micro glossary under SNOMED and this will serve to maintain patient history, findings, services and outcomes. And we are doing this all so that dentistry as a whole can be represented accurately. We are also developing a comprehensive glossary of dental terms.
That work is being paced at the ADA and all the different ADA agencies involved in that from both the standards point of view for our oral health record as well as our computerized-based patient record as a whole. So, again, when that patient record is developed we will have coding systems that are available to populate that and within the dental community we feel very strongly that we will be in probably one of the better positions of the different segments of the industry to really facilitate true analysis relative to our oral health.
In addition, the ADA would recommend that the adoption of standards for clinical transactions that are coming up in the future, again the patient record being one, in any of the supporting code sets be deferred until the appropriate frameworks, data dictionaries, cross mappings and harmonization of the current and proposed standards can be fully developed.
You know, some of this, again looking at what you have heard over the last couple of days, ICD-10 seems it would take ten plus years to implement. CDT is again every five years and we feel based on our current needs that that has met that.
Is it carved in stone? No, but we let industry need for the process that we are embarked upon drive exactly how we develop systems and assure that consensus is there and that our dentists are the ones that are defining codes appropriately.
Question 3, again looking at the different coding, ICD-9 at this point is certainly the coding system that is used and prevalent for our part of medicine. ICD-10, ICD- 10-PCS, sure, as they become viable. Again, it is just a continuing, evolving process as with any standard, as with any coding system. At the appropriate time when they have been tested and proven it would make sense to migrate towards an upgrade.
Question 4 dealing with the current coding environment and how can we improve that and simplify it? It just goes back to you need to use the existing coding standards, achieve administrative simplification as it was originally intended to be and then rely on your four consulting organizations, the ADA being one of them, to monitor and help you in consulting on future modifications of coding systems used in dentistry. Again realizing that some way you need to come up with a balance as to what data you are collecting for administrative simplification, what you are trying, and the additional pieces of information that you are trying to put into this conduit for other activities. It is key to remain a balance in that particular process.
And again, we feel very strongly that, in this initial stage anyway, that the administrative transactions and administrative needs should be the driver not getting sidetracked in the clinical record at this time.
In question 5 relative to ongoing maintenance of the coding sets, we have, as the AMA, a very proven history relative to including both public and private sectors working together with insurance companies, the government agencies, our membership in making sure that any coding system or any standard that is developed within an ADA secretariat function or an ADA standard is appropriately built on the basis of consensus and goes through an appropriate approval process.
And we talked about whether or not copyrights should be held by the individual organization or public. I think it is important to realize that copyright does not necessarily mean that you are forbidding anyone from using that information. It just simply means it is a way of controlling the input and controlling that due process is, in fact, followed. If you look at the ANSI organizations, almost all of their standards are all copyrighted for that reason.
Whether or not they are available in the public domain, CDT is out there. It is simply a matter of a phone call and a few commitments, again, not to changing the terminology that would allow you to implement that and move forward.
Question 6, the biggest area and implications here is what you have heard before. You have to have training and education. You know, in any coding system that you have you are going to have a lot of hardware and software modifications and you are going to have a loss of data compiled based on the current systems that you will lose if, in fact, you just scrap them and go to a new coding system without any cross mapping or any thought process relative to archive data.
Question 7, you know, again, as we stated yesterday, the ADA believes that the administrative simplification and CPR coding standard should be addressed separately. The Secretary of the Department of Health and Human Services should adopt the existing dental coding standards for administrative processing for all the initial K2 regulations and this will give the health industry as a whole the necessary time to complete the development, testing and implementation plan for a computerized patient record. Any attempt to address a computerized patient record coding issues now may prove to be counterproductive to the intent of the administrative simplification under the law.
Thank you for the invitation to address the committee. I will look forward, again, to answering any questions.
MS. COLTIN: Thank you. The next speaker is Dr. Spackman.
Kent Alan Spackman, CAP
DR. SPACKMAN: Thank you. Good afternoon, I am Kent Spackman, M.D., a practicing pathologist at the Oregon Health Sciences University in Portland. Today I am here representing the College of American Pathologists or CAP. The CAP is a medical specialty society representing more than 15,000 physicians board certified in anatomic and/or clinical pathology. College members practice their specialty in community hospitals, independent clinical laboratories, academic medical centers and federal and state health facilities. Thank you for the opportunity to present the College's views on the administrative simplification provisions of HIPAA.
As you are aware, the requirements of HIPAA for adoption and development of standards to facilitate the transfer of electronic health data information have a potential to drastically reshape the U.S. health care system. In theory following the implementation of the HIPAA standards requirements, the transfer of health information in the U.S. will occur within the confines of a national, uniform accessible and confidential health information system.
The CAP appreciates the opportunity to participate in the Department of Health and Human Services' recommendation process. And while the CAP recognizes the potential benefits of a national health information system, we remain concerned about the standards that will be adopted to accomplish this goal. Adoption and implementation of inappropriate standards have the potential to produce undue burdens on both providers and patients and thereby negate the Congressional intent of HIPAA to improve the efficiency and effectiveness of the health care system.
As the NCVHS considers the medical and clinical coding and classification issues surrounding implementing HIPAA the CAP would offer the following comments. First regarding medical and clinical codes and systems currently used for administrative transactions, the administrative simplification provisions of HIPAA clearly mandate the adoption and implementation of standards for the administrative and financial transfer of health information. And implicit in HIPAA is the creation of a comprehensive health information system expanding beyond the scope of administrative transactions to encompass all of the activities in the clinical environment.
An effective information linkage between the administrative and clinical environments is necessary in order to improve patient care delivery. The CAP urges the NCVHS and the Department to keep first and foremost in its recommendations the synergy between the administrative and clinical environments. The systems widely in use today for administrative transactions are ICD-9-CM and CPT-4. These are designed for coding diseases, diagnoses and reporting medical services and procedures, and while both systems work well for their intended purposes, they lack the detail necessary to assess the quality of patient outcome.
Administrative coding systems are not designed for the clinical environment and do not fit the needs of the clinical environment. Furthermore, ICD-9-CM and CPT-4 are classification systems. In contrast, a comprehensive health information system requires the use of a nomenclature or a terminology. The problem is that the particular terms used for classification systems are not generated as a natural part of routine documentation of the health care process but rather are more general terms that are separately coded or abstracted. They do not have sufficient detail necessary to capture all the processes that occur in the clinical environment.
For examples, guidelines are extremely specific regarding the extent of coronary artery disease for which CABG surgery, coronary angioplasty or a medical management would be appropriate. The detail contained in a classification system is not sufficiently specific to make the necessary distinctions. Classification systems are used for billing and global reporting whereas a nomenclature or terminology has the detail necessary to perform studies and assess patient outcomes.
The second reason that I am here, obviously, is because CAP is a developer of SNOMED. With respect to SNOMED the CAP recognizes that no system captures all clinical concepts. However, independent studies have demonstrated the systematized nomenclature of human and veterinary medicine or SNOMED, to be pragmatically one of the most complete systems in use today for the clinical environment. SNOMED, copyrighted and published by the CAP, is a comprehensive nomenclature system designed to encompass all of the terms used in medicine including procedures and diagnoses but going far beyond these.
SNOMED is cross-referenced to ICD-9-CM and can readily be cross-referenced or crosswalked to other classification systems. Therefore SNOMED and classification systems are synergetic systems.
SNOMED provides a mechanism to capture the detail needed to support classification systems and much more. SNOMED can codify all the activities within the patient medical record, including diagnosis and procedure codes and also nursing diagnoses and procedures, patient signs and symptoms, occupational history, the many causes and etiologies of diseases including such things as infectious conditions, genetic and congenital conditions, physical causes of injury and so forth. And in contrast, classification systems such as ICD represent only pieces of the medical record.
The CAP has over 30 years of experience with SNOMED. The precursor to SNOMED, the systemized nomenclature of pathology, was conceived in the late 1950's by the CAP Committee on Nomenclature and Classification of Disease and was first published in 1965. The first major evolution to SNOMED occurred in 1975 when a field trial edition of nomenclature that extended to all medicine was published and distributed for evaluation and testing to 250 test groups representing various health care settings.
Today SNOMED International, the third edition of SNOMED, has gained wide acceptance internationally and is used by both the private and public sectors, including the Centers for Disease Control and Prevention, the Department of Veterans Affairs.
One of the advantages of SNOMED is its ability to adapt to multipurpose coding. For example, SNOMED has been selected by the digital image communication standard, DICOM, for representing anatomical and other concepts in the reports that accompany images in electronic messages. In cooperation with the American Dental Association SNOMED incorporates the ADA's nomenclature, integrating it with SNOMED structure and ensuring lack of overlap while permitting the ADA wide latitude in determining the content of dental diagnoses contained in SNOMED.
Similarly, working with NANDA, nursing vocabulary has been integrated into SNOMED. And we are also working closely with LOINC, the Logical Observations, Identifiers, Names and Codes Committee, to integrate its clinical and laboratory codes into the structure and content of SNOMED.
There are several other professional specialty organizations in addition to this with which SNOMED is working to improve the detail and clinical content and coverage of SNOMED. And the CAP is committed to continuing these many efforts to meet the needs of the users of clinical vocabulary.
And now just with respect to the question about the maintenance of medical and clinical codes and systems, it is important to define the concept in the public domain. If the concept refers to public access of a single, official version of clinical codes and systems, controlled through a public entity, the CAP could possibly support code sets and systems being within the public domain. However, this raises the issue of how the ongoing maintenance of the code sets would be financed. If public domain also is intended to mean free of charge this would imply that the government would have to take responsibility for the costs of maintenance and updates.
In any scenario, whether publicly financed or based on charges to the users, the CAP strongly recommends that health care professionals remain in control of and responsible for the content and structure of clinical terminology.
Recommendations on how to proceed with implementing HIPAA standards. In order to move towards a comprehensive, uniform health information system it is inevitable that costs will be incurred, including costs associated with implementation of electronic information systems, education of health care professionals, health information management professionals and the public about the new system. It will be important to minimize these costs to make the transition as efficient and as effective as possible.
Given the impending implementation date the CAP recommends that the administrative transactions currently in use be allowed to continue, CPT-4 and ICD-9-CM. These systems are well accepted and understood and there is significant investment in the abilities of organizations and individuals to encode clinical information in these existing systems.
Regarding the possible transition to ICD-10-CM and ICD-10-PCS, the CAP believes that further studies and trials should be conducted to establish the relative costs and benefits of these systems. It is not a foregone conclusion that these systems should be implemented.
Simultaneously the CAP recommends that this committee take steps to establish a standard, clinical nomenclature system that can be used to perform utilization review, risk management, quality assessment and other administrative functions. Ultimately a convergence should occur between the administrative transaction systems and a nomenclature system that will accurately reflect the entire patient health care process.
With respect to the CCIT Committee, the CAP would like more detailed information about the process to be used by the CCIT in selecting and recommending the set of health vocabularies needed for full coverage of concepts in computer-based patient records and other types of health data. We recommend that this process be clearly described and open and that there be ample opportunity for input from organizations such as the CAP.
In closing, the CAP urges the NCVHS and the Department to focus on the entire clinical environment as recommendations are developed to implement the administrative simplification provisions of HIPAA. Administrative transaction systems alone do not have the detail necessary to capture the processes that occur in the clinical environment, nor are they designed for this purpose. A nomenclature system is necessary for patient quality assessments and other purposes. The CAP recommends that efforts are made to move toward developing a comprehensive health information system that links the activities of the administrative environment and the clinical environment.
Thank you and I will be happy to answer questions.
MS. COLTIN: Thank you. Dr. Warren?
Judith Warren, NANDA
DR. WARREN: First I would like to thank you for inviting NANDA to give testimony at this conference and just to give you a little bit of background about NANDA. And then I also have organized my comments not only to the first set of questions you sent but also to the additional questions that were mailed out. And what I would like to do then is just highlight some of the things that we thought were critical.
Just to give you some background, NANDA started 24 years ago. The reason we started was to create a vocabulary or a classification system that would capture nursing's contribution within a multidisciplinary environment. In other words, what do nurses contribute that nobody else on the team contributes to that care? And also to develop a system that would be coded to facilitate computerization. So our whole history has been tied up with that process.
Throughout that time we have had some very valuable lessons. We started out as a fully consensus adoption process which led us then to some very interesting kinds of things in our early years where diagnoses were added at one conference by a vote, deleted at the next conference and added back in at a third conference. And so we had a very rich learning curve.
Currently our process for adoption has been based on the American Psychiatric Association's process for adding terms to the DSM. We have had two years experience with that and it is superior to any other process that we have tried. Our diagnoses now can be submitted by any nurse, whether they are a member or not, to the Association. They can be submitted at any level of work-up or development. The process we have is a staged process so even if we are just sent a label without any idea of what its definition is or anything else, that is accepted and it is put through our review process. Before it is actually added to the NANDA list, though, it must be completely worked up through research and evidenced-based processes with(?) a refinement of the label itself, a definition that is operational so that we eliminate a lot of confusion, signs and symptoms or defining characteristics, as we call them, and suggested etiologies of those problems. And at that point, then, they are moved forward for classification into our system.
We also have the distinction of being the first nursing nomenclature to be recognized by the American Nurses Association which came about through a collaborative process that ANA and NANDA put together. One of the outcomes of that was the development of the ANA's steering committee on data bases supporting clinical nursing practice. And when that committee first started NANDA had a seat on that. Since then we have moved that committee totally within the ANA development and NANDA supports the work that is there and periodically reports its progress into that committee. But we are leaving it to them to provide linkages and crosswalks.
Since then three other nomenclatures have been recognized. Two of them are here today and will be reporting right after me and so I will let them talk about their own processes.
When I tried to answer the questions it became obvious to me that many of the questions did not work for nursing and did not work for nursing nomenclatures. So in some of the answers I have kind of stretched a point and I made my own assumption of the intent or the meaning of the question.
So, as far as clinical codes for administrative transactions, nursing has never had a code for administrative transactions except in things like home health care which you have heard that that is kind of a loose association. If we look at the Minimum Data Set for Long-term Care Facilities, there have been several research studies, that cannot link nursing care to care delivered in a nursing home of which physicians visit their patients maybe once a month, or whatever the requirements are, so that the patient outcomes there really are due to nursing care. But you cannot tie those outcomes to that particular provider. So some deficiencies in that.
Within the inpatient facility, and I have said this in the humor that I have always, or I left out some of the humor I have always used, that nursing care has always been embedded with the room charge. My own humor is it is right up there with lights and sewage which is also embedded in the room charge.
Other ways that nursing care is accounted for is to be captured underneath a physician's fee for service. When it is the nurse that actually does the procedure, it is the physician that orders that done, et cetera. A good example of that, in our own facility, I am a practicing nurse researcher and informaticist at the University of Nebraska. We do tremendous numbers of transplants. Within our bone marrow transplant program it is the nurses who actually transplant the cells for that process.
Recently advance practice nurses, and those are ones with master's degree, who provide care have achieved the ability to charge for services. That is a state-by- state decision as we currently speak. ANA has been very supportive and has lobbied with the AMA to have nurses join their CPT panels and that has been done with a lot of collaboration. However this still does not capture what 80 to 90 percent of the nurses in this country do. It only captures those things that you can get by fee for service.
And yet, again, we have numerous research that if you account for nursing care you have a significantly better prediction of allocation of resources and, in fact, if you can account for nursing care we have the Apache studies that show us that we can reduce mortality. If you do not account for it then mortality rates are higher. So we fully believe that somewhere we need to start looking at clinical and administrative codes.
As far as the classifications that we recommend, we fully realize that NANDA is a niche classification and, in fact, we participated in the first study by CPRI and I was absolutely thrilled when I found out that NANDA captured an extremely minuscule -- I forget what was the sum -- .2 percent of the concepts were captured. For me it was one of the best classification validation studies because the only things they captured were nursing things. They did not capture medicine. They did not capture anybody else.
The classification that did come out in that study, and the second one that I participated in, was SNOMED. And one of the reasons that SNOMED performed in a superior fashion was the fact that NANDA had been at that time integrated into the classification and they also had started working on their own system of nursing procedures which addressed primarily inpatient kind of nursing procedures.
So when we recommend, we obviously think that SNOMED is there, as we looked at ICD-9 with CPT-4, that does not capture things that we feel are important for capture in a nursing practice. Also, since nurses traditionally do not participate in formal coding efforts, we were not able to make any recommendations for implications. However, since NANDA is in every major nursing textbook, is taught in all schools of nursing and is throughout our state board exams, every nurse I know of can take a look at a code list and accurately classify and code the nursing diagnoses that are there. So that, for us, I do not think would be a problem since the update right now is every two years and most of these schools and the exams are in sync with that, as well as the textbook publishers.
I have to admit we release our codes every two years mainly as a request from publishers because even with every two year cycles they are going crazy trying to issue new editions to account for new phenomena within that text.
When you asked us what version of ICD should be used, we have looked at ICD-10 and prefer that particular ICD version over ICD-9. One of the concerns we have in talking about ICD-10 is later you have a question about should we leave the world, the international medical classification effort within this? We have had a very interesting history with the ICD-10 in that very early on as it was being developed we were trying to submit NANDA's terms into the ICD-10 process. We learned that first you had to go through World Health Organization and the only nursing organization they would listen to is the International Council of Nursing which is within the WHO structure.
When you look at the International Council of Nursing, the United States has one vote out of 130 some odd other votes. The ugly Americans were not appreciated as coming in and in a last minute effort trying to dictate what would go in. We also found out at that point that NANDA could not submit terms to the ICN; only ANA could. And that was what started us working very collaboratively with ANA.
As a result of that, we have found out within the last couple of years that ICN now is developing their own international classification of nursing practice and that the leadership for that effort is with the European countries. ANA and NANDA both though have, in a collaborative way, offered to become reviewers for that system, to provide any kind of consultation that they choose to request. And so we are at that point of working with that particular classification.
I think the other point that comes up loud and clear has been the issue of copyright. NANDA for a long time stayed within the public domain. Part of the problem we had with that was textbooks and other materials being developed were misusing the classification but still calling it NANDA. So we were getting a lot of bad press for some sloppy work.
In 1992 we copyrighted NANDA. The copyright is mainly our traditional method of quality control and version control when we release our new terms. If you are a clinician and want to use it in your hospital, all we request is that you call the NANDA office and request permission to use it and that is all it takes. If, however, you are going to take NANDA and develop a product that you intend to make profit off of, then we require a royalty fee. So we are collecting royalties from publishers, from software vendors and from several companies who make it their job to do major workshop delivery where they [unintelligible] in publishing their own documents with NANDA in it.
You also asked whether or not we had any concerns about the process that the Department was using to do this work. Actually, we are absolutely delighted with the process so far. I have to say this is the first time we have ever been involved or asked by the government to be involved. We will do almost anything within our power to continue that collaborative process and to assist and help in whatever ways that we can.
You further asked us about if we went to one classification system what would be the budgetary constraints for us. Right now NANDA is involved in several collaborative projects. We are obviously working with the International Council of Nursing. We are working with SNOMED. We have worked with the National Library of Medicine in order to embed SNOMED into, -- embed NANDA into -- the UMLS.
We also have relationships with three research teams at the University of Iowa. One of those is a research team that is extending and doing more work on the development of diagnoses. The other two teams, though, are working on classifications for interventions and outcomes. What we are trying to do is make sure that as those other two niche classifications evolve, that all three of them will work together and you can follow the links, you know, across all three systems. Trying to have one organization do the work of all three of those has been far too expensive for any one organization to adopt so we have chosen this particular format.
One of the concerns that I had about implementation of ICD-10 is if that is going to be the system that we are going to migrate to, that needs to be announced pretty quickly with forcefulness or else people will continue to not think it will ever happen and you will always have a last minute implementation, gnashing of teeth and wrenching of hand. So, I agree with Marge when she talks about that.
To end the particular concern I have is it is becoming very obvious through my own clinical agency that we are doing a lot more collaborative work with families to care for the chronically ill and, in specifics, transplant patients. If these families are going to be contributing to the patient record, just to make things muddier and worse, they will also need a language to document the care they deliver and those patient responses, a language that is meaningful to them.
We are going to have the same problems with them(?) that we currently have between the various disciplines. We have talked to you about the language of medicine, the language of dentistry and the language of nursing, not mention the language of psychiatry, et cetera. And all those languages have cultural influences that are going to contribute to the meaningfulness of that data and the accuracy of it. And so those things need to be addressed and probably can be addressed within definitions and standards of coding.
With that, I think those are probably the high points that we have, other than we are also very concerned about the degradation of data integrity as it is abstracted, summarized and coded upwards. Especially the fact that our country uses this very messy data in order to set policy on what we think is the health of the country but probably is very different for it odds(?) with the codes that are migrated up. Thank you very much.
MS. COLTIN: Thank you. The next speaker is Dr. Bowles.
Kathryn Bowles, OMAHA
DR. BOWLES: Good afternoon. I am yet another Kathy. If we were going to classify or code the names in this room today I think we could all agree that Kathy would be the most popular name.
[Laughter.]
I am Kathy Bowles and I am from the University of Pennsylvania. I am a nurse researcher there. And, I am happy to be here, thank the committee for inviting me to represent the developers and the users of the OMAHA system.
The OMAHA system was developed through four federally-funded studies that started in 1975 and so it has been in use for over 20 years. It was derived from actual documentation across clinical records so from the home care records it was derived. So it is in terms that are familar with all nurses.
It is available in the public domain and as Judy has said, it has been recognized by the AMA, the ICN and the National Library of Medicine. The OMAHA system's features are that is an inclusive system that can link patient problems with the nursing interventions and the outcomes of care. So in that way it is an all-inclusive system.
It lists patient problems into 40 categories under four major domains. It has an intervention scheme of four categories with targets that further describe the detail that we have heard today that is needed to describe the nursing care. And it has a problem rating scale. It is a lycra(?) type scale that ranks the patient's progress in relation to a problem. So it relates back to the problem, the original problem the patient had, and allows you to rank their progress from admission to discharge.
As we have heard, some of the weaknesses or concerns that we have about our present methods of data management are that at the moment nursing is in a handwritten format in most places and therefore it is unretrievable. It is in handwritten records that hardly anyone looks at and can get information back out of. Those records are also redundant and inefficient when you are charting several things, the same thing in several different places. It is inaccessible with too many people needing the record at one time and waiting for each other. There are inaccuracies and it is incomplete.
Also, without the ability to code and retrieve nursing information we are providing our researchers and policy makers with an incomplete health care data base. So we are missing the nursing care that the patient received.
Some of the strengths of the OMAHA systems are that, like I said, it has elements of the Nursing Minimum Data Set in it. It can classify problems, interventions and outcomes. It gives you the ability to describe and quantify practice so as you are coding the problems that patients had you can go back and say what types of medical diagnosis corresponded to what types of nursing problems and what did the nurses do about those? It also enables us then to link those things to the outcomes of patients.
When used in an information system, as it has been in many places, we are able to use it simultaneously as a care planning guide, a system of documentation and a system of information management. It has been used by clinicians, administrators, faculty, researchers and students. And one of the recent HCFA-funded demonstration projects, the Community Nursing Organizations has chosen the OMAHA system for their documentation system to provide the quality feedback that HCFA has mandated for that program.
It has a flexible architecture which allows you to add terms that you are not finding within the categories and revisions. And, we heard that before with other systems, that there is a need for an other category to capture terms that are going to come up in day to day practice.
Users have reported that the use of the OMAHA system as their documentation system helps them to reduce this redundancy in the clinical record. It improves efficiency. Home care agencies that have used it have been able to report an increased number of home visits being able to be made per day by computerizing the documentation. And it increases compliance with your federal regulations, so your JCAHO standards or your other agency outcomes that are searched for in the clinical record.
It also within the information system can prompt practice. Where we would have signs and symptoms, the nurses choosing, and it helps you to come to what is the problem the patient has and may lead to planning the interventions. And so the quality care would improve. It also provides aggregate outcome data to help you evaluate quality, as I have said.
Being that it is over 20 years old it has been used, as last surveyed which was in 1992, in over 250 sites by approximately 4,000 users and this has grown substantially since this last survey. There is increasing interest in expanded use across integrated care settings. The system was originally designed from community health records and used most frequently in community health settings. But it has started to creep into the acute care settings in hopes of being able to bridge the gap between the hospital patient going home to home care and having a common language of being able to describe the needs of those patients as they traverse our integrated health systems.
There are at least seven companies that have integrated the OMAHA system into their software and it can be used as a stand-alone clinical information system or as a module within a medical information system. It is used in a variety of settings, as I said. It has been used internationally and it has been translated into five different languages.
Users have reported improved job satisfaction and productivity from the nurses who are using it. The VNA of Chicago has reported great success with use of the OMAHA system in complying to regulatory standards and for tracking data for costs and benefits of home care.
Research on the OMAHA system has reported that it enables us to code what exactly were the patient problems, how many times did the nurse visit that patient, how long did they stay, what were the types of problems that they had and what were the interventions that were done for those problems? So we can take a look at resource consumption and intensity and severity rating of the types of clients that we treat and come up with some variables for case mix and resource consumption.
Studies have shown that when looking at what problems patients have that nurses handled, some of the variance of length of stay in the hospital has been described, as much as 45 percent of it, based on nursing care. And in home care the studies range from 17 percent to 74 percent of the length of stay in home care and numbers of visits being explained more fully by the nursing data. So it is really providing us with some useful information as far as costs and utilization. And as has been said by Judy and myself so far, it does help us to provide a full description of care.
If I would have a wish list of future improvements that we need to think about for these systems, we want the ability in the future to link them with expert systems. As we learn more about the care we provide, as we are able to aggregate data and look at types of patients and interventions that we do for particular subgroups, that we can develop expert systems to help guide care to improve quality and decision support.
That we be able to crosswalk all the systems so that the strengths of NANDA and the home health care classification and any others that come up can be used by a variety of people and be crosswalked so that you may choose the system that you feel most strongly meets your needs depending on your practice setting.
I would also hope that our systems would include practice guidelines and clinical pathways that would help to guide the care and guide the quality of care. And that all systems would have a method of being updated and revised.
And finally, essential features would be interest in determining the point of care data entry. This is very important for user friendliness and to get people to do the coding, that it is done on the spot. And someone else mentioned this, that it is a part of the day to day documentation system and not something that has to be done on top of all the other work, that it is integrated into the daily documentation.
That it does include all the elements of the Nursing Minimum Data Set. There are 16 elements that nursing has identified as essential for our records and so I would hope that any system would include all those elements. And that it enables linked clinical data for multiple uses so we are an integrated health care system with multidisciplinary teams caring for these patients and that we can recognize the terms that are used by each other and pull up screens that have common information for each other to work collaboratively. Thank you very much.
MS. COLTIN: Thank you. The next speaker is Dr. Saba.
Virginia Saba, Georgetown
DR. SABA: Thank you. Good afternoon. Well, we are here and that is the most exciting thing of all. Nursing has finally arrived at the table. I have been coming to these meetings for I cannot tell you how many years, and now that we are here, I am very pleased --
[Microphone adjustment.]
I did not have it right. I do this every time I teach distance learning. I start talking into the wrong piece of technology. Thank you very much.
Well, I will start over again saying we are glad to be here. Three of us, four of us have been presenting these past two days and finally we feel that we can offer you some systems, some vocabularies, some classification schemes that can be used to enhance the patient record.
The home health care classification system was developed at Georgetown University School of Nursing in the late 1980's and early 1990's. As you can see from our presentations we are all overlapping our research. We have all sort of enhanced, expanded and worked with each other and yet tried to develop a new piece of information to advance the practice of nursing. And that is the reason that the home health care classification of nursing diagnoses and nursing intervention does have a place in today and hopefully in the electronic patient record.
We all know that home health care goes on in the community and traditionally it was called care of the sick at home. We believe that care of the sick at home, which was started in Henry Street in New York City, frontier nursing in Kentucky, continues today but what we have today in the home are sicker and quicker patients that have been discharged and need care.
As a result the nursing model that was started in the early 1900's has been converted into a medical model for reimbursement purposes. So what we have is nursing carrying on with the tradition, however the reimbursement, the proprietary agencies have taken over and have now, are in control of the care that we can provide because that is what is allowed by HCFA and that is what is paid for by the third-party payer and/or the insurance companies.
During this period between 1966 and 1996, when Medicare first came into being there were 1,175 home health agencies that were certified when Medicare first came in. As of 1996 there are now over 9,000 certified home health agencies, which I believe you heard about yesterday, and some 20,000 total providers dealing in the field of home health care. We now have a big, booming business and we are still providing care in the home the way we did in the early 1900's and we are still providing what we say, care of the sick at home. But may I repeat, care is sicker and the patients require more care.
The early systems that were developed were the billing systems primarily for financial purposes and those are the ones that still exist today. These 28 vendors, I understand, are decreasing in numbers. They are buying each other out and they are consolidating their efforts to take over the market.
But in any case, the computer systems that do exist today in the field of home health care are primarily for reimbursement, for financial management and, as my colleague said, the documentation of patient care is still done manually because we have requirements according to our professional standards to document what we call the care process. The billing system is the insurance provider activity and it is not documenting the care process which is a professional requirement.
With that in mind, I would like to proceed to a description of the home health care classification of nursing diagnoses and nursing interventions. We have at this time 145 nursing diagnoses with three modifiers and 160 nursing interventions with four modifiers that are structured according to 20 care components. These are the chapters in our book. Instead of using body systems our chapters in our book are based on these 20 care components that are categorized as the components that we in the profession look at when we provide care to clients, whether it is in the home or, we think, in the ambulatory care setting as well.
These 20 care components are defined and are listed in my testimony which has been distributed. They have been organized and are used to code both the home health care classification of nursing diagnoses and the home health care classification of interventions.
What does this mean? This means we can link the two together. This means we can track the care process from admission until discharge. This means we can enter the codes which are current according to ICD-10 into our computer system very easily, retrieve the data, view the data elements, with minimum amount of computer effort.
Here is an example of a coding strategy that has been developed for the nursing diagnosis. We use the ICD- 10, a five-digit code with an alphabetic first level for the care components; a two-digit major level for the major care diagnostic category or label and then a third digit for the subcategory which is the classification. You have to remember this classification was developed from empirical data and is valid and reliable.
Here is the second one which is the home health care classification of nursing intervention. Again you can see that it has a five-digit code but the modifier instead of being a three is four. And this is very critical to the classification. If you look at ICD-CM, the structure of the new coding strategy, they have different cells for different areas of the structure. The four here refer to the assessment of the care, the performing of the care, the teaching of the care and the managing of the care. So therefore, in essence, we have 640 nursing interventions at this point in time that are coded, that are reliable, that are valid and that are very user friendly.
Now, how did we get here? The Home Health Care Classification came from the Home Care Project which was federally-funded by HCFA in 1988 and which was ended in 1991. The purpose of that project was to develop and predict home health care requirements. We did do a study, a national study of some 646 agencies and collected -- and I wanted to tell Ms. Weiss -- we collected data from records retrospectively from the entire episode of care. And we had similar problems that she had with the medical records, we had with the nursing records. But because we had a data collection tool we were able then to code and classify and come up with the largest data base on home health care that was ever compiled in the country and which is now residing at HCFA.
As a byproduct of the study we did collect 40,000 statements about diagnostic categories, about patient problems that were handwritten in on these 10,000 cases and we collected some 70,000 services, treatments, actions that were also provided. This was a way of the industry telling us we want a coding system, we want a classification system and we need it for the sicker patients in the area of care in the home.
Here is an example of the one code that was put into the UMLS, where the scheme now resides, abuse control. As you can see, it tells you, and I believe Betsy gave a description of the UMLS yesterday or today, but it does describe the term, where it is located, how it is defined. And all the codes for the Home Health Care Classification, along with the other three schemes that have been submitted by the American Nursing Association, are now a part of UMLS.
By the way, if you do a draw-up of the nursing terms you come up with 6,000 links, if they link to the other terms that are also in that data set. This is an exciting time for us. Lots of research is going on. A lot of doctoral students are working with these data sets, all of them, and they are trying to come up and hopefully down the way we might be able to come up with some commonalities which we feel is apparent.
So, why do we want the Home Health Care Classification system in your electronic patient record? We want it because it has a coding strategy that complies with ICD-10-CM which I understand from today will be in place, hopefully by the year 2000. The scheme is coded according to atomic level data which means that every data element is defined, is unique and can be retrieved separately from the modifiers and the qualifiers that I mentioned before.
Here is an example of the five-digit code for, and it has the complementary code for the interventions.
This is hard to see but it is a way of instructing the nurses on how to actually code either a diagnostic problem or a procedure and then how the two are linked together.
So the Home Health Care Classification is categorized by these 20 care components. For your information we are using this framework of 20 care components to teach our nursing students at Georgetown University School of Nursing. Each faculty member takes the components that are indicative of the topic they are teaching or the course they are teaching and this is how we teach the students nursing. We use this in collaboration with the nursing framework which is the American Nurses' Association nursing process which is basically our standards of care.
We feel, it is being implemented in several laptop systems whereby you can go into the home and collect your data at the point of care. Several critical care pathway systems are being developed using the vocabulary.
I have been called by just about every hospital and home health care vendor in the country saying can we include your vocabulary or the home health care vocabulary into our data dictionaries so they can map or be offered to our customers and our clients, and since it is a public domain package classification they have complete freedom to do so. It is on the Internet from our Georgetown Medical Center Library address.
This is the conceptual framework that it follows. As you can see there are six steps. In the computer systems where they are being developed they are all behind the scenes. We have been working with one firm whereby you enter your three or four key assessment variables and out comes the whole care plan; the expected outcomes, the interventions that are to be performed, which you validate and/or delete when you make your first visit in the home. The nurses love this because they can document care within a matter of five to ten minutes instead of the one to two hours that it took to admit a patient prior to the development or the use of any computer-based patient record.
What can I say? It is being used in the care process. In my short day here it seems that the care the patients get is the missing link to all the coding strategies that have been presented. Nursing care, patient care, interdisciplinary care has to be addressed. It is the critical piece and the missing link that we need in all of these systems.
As Judy pointed out, we tried for a chapter in ICD-10. It did not make it. So now we are looking to WHO for our own book and it will be made in three parts; diagnoses, interventions and outcomes, and have our own chapters. And they might be these 20 care components. They are playing with them in Copenhagen. They are testing them at the University of Virginia. And we are still adapting, expanding and enhancing the scheme with the research that goes on at my university.
I have to show this quote. We show it everywhere we go and we believe that this is the only way we are going to get and keep our professionalism accepted by all the members of the health care team. And that is, we want to name it and we want to control it so we can get paid for it and put it into public policy, which is what we are hoping that we can do today.
So that my goal, hopefully, at least we are going to be in the publication that will be presented because that will be a part of the electronic patient record, the Home Health Care Classification will be there and it will be just one of the four nursing schemes that are in that report, but down the way with a lot of work from this committee, and with all the schemes you have to address, that maybe some piece of it will get into the final product and be in that classification that gets funded and approved for this legislation that we are all working for. Thank you.
MS. COLTIN: Thank you. Our next speaker is Peter Goltra.
Peter Goltra, Medicomp
MR. GOLTRA: Thank you Madame Chairman. I am Peter Goltra, president and founder of Medicomp Systems, a Virginia company incorporated in 1978. My presentation will be very short. We have been here for two long days and I will try not to add to that.
I am presenting MEDSON(?) a nomenclature for a new approach to billing and I do so with the realization that you have a stated goal to achieve, that is, administrative simplification, and that substitution of a complicated, computerized billing structure for a complicated manual one would not meet that goal.
We are proposing that the committee recommend the recently published MEDSON nomenclature as a way of making the goal achievable. And I will explain exactly how we suggest that.
I believe that the committee has all received a copy of the nomenclature. The MEDSON nomenclature was created in the process of trying to describe medical diagnoses. This included for diagnostic purposes description of the clinical presentation and appropriate tests together with possible results. It also included the appropriate therapy, including procedures, for intervention and management purposes. We called that resulting file MEDSON Expert and I will talk just a little bit more about that.
Why MEDSON is important to the committee? They have vital interest because in our EMR system we use MEDSON Expert to analyze the patient's chart in a few seconds and prompt, amongst other things, appropriate diagnoses and procedures for the physician's selection. This allows, with the entry of only a few findings, a list for the physician to pick from, an expert system-driven list, to header those diagnoses and procedures which can then pass through the coding system. This feature was recently reviewed by Kunutes(?) and Associates, KEI(?) of Rockville, Maryland for Dr. Harvey Schwartz of the Center for Information Technology of the AHCPR.
With expert system prompting of appropriate diagnoses and procedures, no further entry or coding is necessary for billing. Manual coding errors and costs are eliminated. This capability is currently operational in MEDSON Expert for over 3,000 diagnoses. And I mention again this has been under development since 1978.
Nomenclatures which require combining terms to make phrases are intellectually appealing because of their flexibility. However, the flexibility includes the ability to say the same thing using different terms and codes. This unpredictable redundancy makes them unusable for billing, for outcome studies or for expert systems. MEDSON has a fixed phrasing which prevents redundancy.
Our proposal. We propose that the existing ICD-9- CM, the CPT-4 and the HCPCS structures be left in place and that MEDSON be used as the underlying nomenclature to provide the detailed for detailed, accurate outcome studies. Since there are existing mapping files from MEDSON to ICD, CPT, HCPCS and other coding schemes, a recipient can accept and the sender can forward either MEDSON codes or the ICD, CPT, HCPCS codes or both.
Very briefly, because there is a long, I believe you all have the, yes, there is more detail on MEDSON so I will not take up your time now describing it, but some important MEDSON features, no knowledge content in the codes. The codes are permanent, not changed, never deleted. Structure is hierarchical with cross-hierarchy referencing files. No redundancy. Content granularity in history and physical as well as diagnoses and procedures.
As I said, the goal is administrative simplification. This can be done without changing the coding structures or rewriting software which would entail, obviously, huge costs.
The recommendation of MEDSON as an underlying nomenclature supplies the detail missing from ICD-9 and CPT- 4 without replacing them. It enables detailed and accurate outcome studies. EMR systems using MEDSON Expert files enable the physician to enter appropriate diagnoses and procedures quickly and accurately. No further entry or coding is necessary, as I said before. MEDSON Codes and MEDSON Expert can be used for automated, on-site review of the chart before submission of diagnoses and procedures for payment. Submission can be in MEDSON codes, in ICD, CPT, HCPCS codes or both.
I mention the license fees only because it answers one of the questions in the submission. The MEDSON nomenclature license is available for any size site for an unlimited number of users for a nominal $25 a year. This is strictly, as mentioned earlier, in order to control the nomenclature.
Our model for the business is in MEDSON Expert. That is available for $15 per year per user. And these prices have been published as valid for ten years starting this February 15.
To conclude the written presentation. I would just like to make a couple comments after this. The members of the committee are invited to review and to evaluate MEDSON and MEDSON Expert at our Chantilly, Virginia headquarters. We would be happy to demonstrate it here in Washington for the committee at your convenience.
Some thoughts on the overall procedure. Dr. Harris of the AMA mentioned appropriately that codes are not added to the CPT-4 until the efficacy of the procedure has been established. Similarly, they withdraw codes when the procedure is no longer used. An underlying nomenclature provides continuity so that as those codes necessarily change the record is maintained intact and various studies, outcome studies and research can continue. Similarly, drugs are removed from the market and yet there is a need to record that those drugs were given. You need to record that the procedures were done in the past even though they no longer have current codes.
So, what I am saying is that if you leave the situation as it is, but allow for the marketplace to supply nomenclatures which underlie these structures, then it is my belief that the marketplace will solve the problem, not only for the issue you are addressing today but also for the issue you will be addressing in the next couple of years, namely a nomenclature for electronic medical records. Thank you very much.
MS. COLTIN: And our last presenter is Vivian Coates.
Vivian Coates, ECRI
MS. COATES: Good afternoon. I will try not to put you to sleep. I am Vivian Coates, vice president at ECRI for Information Services and Technology Assessment. I would like to thank the subcommittee for allowing me to present ECRI's comments in this arena on coding and classification issues in connection with the requirements of the Health Insurance Act.
Today I will be speaking to you not about procedural and disease coding systems but about another health data element important to patient care, medical devices.
By way of background about my organization, we are a non profit, non governmental, health services research agency and World Health Organization collaborating center for information transfer on medical devices. For more than 25 years we have developed, maintained and continuously updated a standard controlled vocabulary and coding system for medical device classification.
This nomenclature, the Universal Medical Device Nomenclature System, covers all medical devices, equipment, supplies, disposables, clinical laboratory instrumentation, reagents, test kits, surgical and dental instruments, et cetera. In other words, medical devices thus broadly defined can include almost any non drug item used for patient care.
ECRI recommends that our device nomenclature be considered as a standard for administrative transactions to encode patient record information related to the use of medical technology. I will now present our rationale for this recommendation.
Our device nomenclature is currently in use in thousands of institutions worldwide, including regulatory agencies, other agencies within national ministries of health, hospitals and health systems. It has been translated into ten languages including Spanish, French and German. It is used to index and structure a wide range of clinical and technical information.
Applications utilizing it range from regulatory data bases on medical device incidents to software for medical device inventory control in hospitals to bibliographic data bases such as our own and also the National Library of Medicine's HEALTHSTAR.
Under a memorandum of understanding that we signed with SEM(?) the official standards body of the European Union, the nomenclature has been adopted as the interim device standard for electronic communication among regulatory agencies of EU member nations. This nomenclature will also serve as the basis for the final standard in Europe and for the international standard currently in development under ISO technical committee 210.
Under a partnership agreement that we signed with the U.S. Food and Drug Administration we are assisting FDA to harmonize its present device nomenclature system with ours to support use by the global community including health authorities, medical device manufacturers and health care payers and providers. The Center for Devices has been very open about recognizing the limitations in its device coding system and they intend eventually to using the new standard in support of global harmonization requirements.
The concepts in our device nomenclature have also been incorporated into National Library of Medicine's UMLS. For the past five years NLM has contracted with ECRI to map and link medical device concepts to other controlled medical nomenclatures in UMLS. And currently, device concepts and terms are already linked to ICD, CPT, SNOMED and other source vocabularies in UMLS providing a practical tool for crosswalk among these systems.
ECRI licenses our nomenclature. We copyright it to ensure system integrity. But we provide it free of charge to health care facilities, government agencies and others. Related data applications that we develop, however, such as publication software, CD ROMs, et cetera, are available for a fee.
Coding systems such as CPT and HCPCS, in our view, do not, in most cases, explicitly identify devices used in procedures. A procedure may be heavily device-dependent but this may not be apparent from the CPT or HCPCS code. This has long been a problem and it is a growing problem as the number of devices continues to increase.
The problem is compounded because many of the institutional controls that exist for inpatient care, such as standards and protocols for technology use, may not exist in outpatient settings where increasing amounts of care are delivered. Hospital admissions in a cost containment and managed care environment are often intended to provide patients with access to a specific technology or medical device. Without device-type specific coding it is difficult to track the diffusion of devices throughout the health care system and ensure payment for their appropriate use or monitor resource consumption in this area. This was clearly seen in a pilot study that we did for HCFA in 1994.
We feel that the need to track the use of specific medical devices also has implications for the computer-based patient record. Data from the computer-based record should be retrievable to support analysis for many purposes.
For coding encounters involving medical devices one could theoretically choose from three possible levels of classification. The first or lowest level comprises makes or models applying to only one particular product from a single manufacturer and described by a unique designation supplied by the manufacturer.
In response to a comment from Dr. Braithwaite earlier today, there are more than 1 million possible products that can be identified at this lowest level and it is very difficult, if not impossible, to develop a controlled vocabulary for this level. And I am not suggesting that this be done.
The second possible level is at the medical device product grouping level for sets of devices with similar properties and uses. This level is the level which is most useful for coding and controlled vocabularies. And the ECRI device nomenclature currently includes approximately 6,000 preferred terms and codes at this middle level.
A third possible level which would be broader could comprise medical device categories such as all electrical medical devices or critical care devices. We believe that coding at this level of classification is actually too broad to capture enough detail about the specific types of devices used in patient care.
While it is important for some applications, such as procurement or inventory control, to retain information at the level of individual manufacturers products, without a standard nomenclature at the device grouping level it is impossible to build information systems that will support a broad range of needs. Data retrieval for health services research, coding for reimbursement, outcome studies, technology assessment, post-market surveillance or any evaluative purpose where it is necessary to look at administrative data concerning the use of similar products really requires this second level approach.
In addition, published reports in the clinical literature data bases such as MEDLINE and HEALTHSTAR rarely provide information at the specific product level. However, emerging applications for data base searching based on UMLS and utilizing the ECRI device nomenclature for device- related concepts will offer relevant information retrieval from clinical literature and other types of data bases.
To support the wide range of analyses using patient outcome information it also is critical that the standard nomenclature for devices for the computer-based patient record be dynamically linked to other medical concepts, including those for reimbursement procedures and diseases. As I said previously, this mapping and linking or crosswalking, at least the framework for it, is already in place for the device nomenclature in the context of NLM's unified medical language system.
In summary, we believe that ECRI's device nomenclature would be a valuable standard both for electronic transactions under the Health Insurance Act and as a core data element for the computer-based patient record. It does not substitute for catalogue number or bar code product-specific designations, although it is possible to make product-specific designations a subset of this broader nomenclature.
Thank you for your attention and the opportunity of giving you this perspective.
MS. COLTIN: Thank you. I would like to thank all of the speakers. This was very informative. We are going to take a very brief break, just to let people stretch. This has been a long stretch of presentations. And I would like to resume promptly at twenty minutes of. Thank you.
[Brief recess.]
MS. COLTIN: We are reconvened. I would like to entertain questions for the panelists. Anybody here on the committee have questions?
DR. IEZZONI: I have been told that I am not supposed to ask questions --
[Laughter.]
-- but I cannot resist, Dr. Harris, I have to ask you a question.
Over the last day we have been hearing a lot about ICD-10-PCS, the new procedure classification system that HCFA has contracted to have designed. And a lot of people have urged caution before implementing that. And apparently their field trials, I guess the person from the VA mentioned that her setting was having a field trial of the ICD-10-PCS. And I just wondered if we on the committee decide to go to - - if, underlined 13 times -- if we decide to recommend a single procedure classification system and we chose CPT-4, has it been widely tested in hospital settings? I mean, I know that it has been used in doctor's offices, obviously, for years, but has it been tested in a hospital setting? And, if not, what might be some of the issues that you might see around its application for hospital procedure coding?
DR. HARRIS: I am afraid you have probably asked the wrong person. My expertise, if any, is not in ICD-10, it is more in CPT.
DR. IEZZONI: No, I asked about CPT. Has it been tested in a hospital setting?
DR. HARRIS: Oh, yes. CPT? Oh, yes, CPT is used by every hospital in the country. It is used for all of the outpatient work.
DR. IEZZONI: Okay, so do you anticipate any, if we asked hospitals to code for their inpatient work using CPT-4 what might you anticipate might be some of the issues, and has it been tested for that?
DR. HARRIS: I think everybody does not want to change. Anytime you use a system you do not want to change but I do not think there should be a lot of resistance. Two reasons; they are already using CPT so that it is not a new system. They can just use one system instead of two systems. I really do not see anything inherently wrong with just using the CPT system for inpatients.
Another thing that I am not sure has been expressed is the fact that we are moving out of hospitals, inpatient care, more and more and more. I do more coding in my office in one day than the hospital does for procedures in a day. And as we move to ambulatory care and outpatient surgery and care in the non hospital setting, actually inpatient procedure coding is decreasing rather than increasing. If you take the number -- and I do not have that kind of data -- but the number of codes or procedures that are reported for payment, I am sure the outpatient and doctor's office and the ambulatory settings must be many, many times those of inpatients.
It seems to me, without any known study, that it would be more economical, well received, to move to CPT for both systems, both inpatient and outpatient, as far as procedures are concerned.
MS. COLTIN: Other questions? Marjorie?
MS. GREENBERG: I am not sure you were here yet when we had the panel of agents, of federal agency data users, but several people mentioned the need, one, the need for a hierarchical data system for statistical reporting and for producing data from statistical surveys. Also, the representative from the National Center for Health Statistics, although the NCHS has a long standing hospital discharge survey and it codes data in the ICD-9-CM, Volume 3, as is currently the practice in the community, however, NCHS also has several ambulatory care surgeries including a national survey of ambulatory surgery, outpatient emergency department, et cetera, and in the community those are all coded in CPT-4.
And yet, it has not been possible for NCHS to use CPT-4 and I think this is a real disconnect between statistics and the administrative. And I just wondered if there was any, I mean, I believe that this could be worked out, but do you see a problem of a procedure classification system that cannot be used in the survey work of the Federal Government.
DR. HARRIS: Well, I think, hierarchical in nature is one of your concerns, is that --
MS. GREENBERG: That is one of them and then the, -- be able to use it.
DR. HARRIS: We already have an exploratory committee within the CPT process looking at that very issue. We have heard that statement, that people want more hierarchy in the system. We are already making moves to do that and we plan to do that.
The one thing we would like to do is not throw away all this knowledge that it has taken us years to get coders and physicians to do, but to be able to take the present system, add to it, make it more hierarchical and yet preserve all this knowledge base.
It has taken us many years to get physicians to learn to code, and the truth is, a lot of people say, well, you have some clerk in your office coding. In my office, and I think in many offices of people who do primary care, the physician has to code. Nobody else knows what he does. So that to be able to continue a system that serves us well, we certainly will change the system, make it more hierarchical and try to meet those other needs that various people have expressed and we do have plans to do that and are actually working on improving the CPT in that sense. Now there is no official name to it, but if that happens that would be CPT-5 and presumably would still come out annually. So there are efforts there. We hear you and we are willing to do what the community as a whole wants us to do to help make it more useful.
MS. GREENBERG: The other issue that was mentioned was the inability to publish codes with code descriptions in reports. And I do not know, again, without that ability it is not possible to use a classification in a federal survey.
DR. HARRIS: I am not sure I understand --
MS. GREENBERG: I think that also needs some exploration.
DR. HARRIS: -- what that is. [Unintelligible] you had a comment(?), let me ask staff about that. I am not sure about that. I did not even understand the question.
PARTICIPANT: I really had not heard that comment before and I was not here when the other panel was, but the fact of the matter is we provide CPT to federal agencies across the board free of charge to use in a whole variety of surveys, not only HCFA but Department of Labor, Department of Defense, CHAMPUS, VA, they all use CPT and they all use it for research purposes. So I would, you know, certainly like to follow-up --
MS. GREENBERG: I think this needs to be revisited. I just did not want to leave it unmentioned since you were not here --
DR. HARRIS: Well, thank you --
MS. GREENBERG: I am hopeful a solution can be found.
DR. HARRIS: We will be happy to look into it. I just was not aware of that.
MS. GREENBERG: Okay, thank you.
MS. FRAWLEY: Kathy, I have a question. Donna, I would just like to follow-up a little bit on some of your comments. I know you are talking about right now some of the work that is still going on with ICD-10-CM in terms of some of the input that you are getting from a variety of groups, and then your planned discussions with the AMA, AHA, HIMA in terms of some of the review process.
Can you give us a little bit more idea in terms of time line, in terms of when it would be, you know, available for testing and, you know, really educational efforts in terms of what you envision a realistic time line is from your perspective?
MS. PICKETT: We have had to reexamine our time lines. As you could tell by my report, most of our work began prior to the authorization of the Kennedy/Kassebaum legislation so we had some time frames that were set not based on that. So we have now had to go back and take a look at what those time frames will be.
Assuming that we can move toward a year 2000 implementation, we will have to reassess and then look at other ways to speed up the process. We do not want to, however, exclude anyone from the comment period while we are working on this phase of our draft. But when we do send out the materials for review -- right now we are working on the tabular changes and until we finalize the tabular changes we will not be working on the alphabetic index -- but for those who do a full review, as HCFA would have to do for any DRG assessment, an impact analysis, they would require an alphabetic index.
MS. FRAWLEY: Just a follow-up, too, on that particular point in terms of perspective payment. I mean, we have always been under the assumption for many years that we would be rolling out ICD-10-PCS prior, you know, to the enactment of HIPAA and we know that the PPS system right now is based on ICD-9-CM for diagnosis and procedure. What do you think the impact would be, would you be able to move 10 out, CM, realistically, without HCFA moving forward with PCS?
MS. PICKETT: I think we would have to hear from the industry what the impact would be. The original plans, again, which were prior to the Kennedy/Kassebaum, were that we would roll it out together to try to minimize the impact on the industry. However, if one system is ready before the other, I am not sure how the industry would feel about that, I mean, they, not even hearing about it at this point.
I mean, that was something that was discussed in one of the previous presentations about the possibility of doing that. I think we would have to hear some more about that and I know the coding and classification implementation team would also have to incorporate those types of issues into their overall processes for looking at what we are going to do in phase I for the team charge, as well as looking at implications for phase II which would be focusing on the computer-based patient record.
DR. IEZZONI: And kind of another follow-up, Donna, is the version of ICD-10-CM that you are working on right now available for just regular folks to look at?
MS. PICKETT: At this point we have not done that because we knew that there were particular problems within either certain sections of certain chapters or with certain chapters. So what we have tried to do was start with the focused review to kind of get the added specificity or correct any problems that may have been encountered with lack of particular codes for certain entities, to try to clean those up first before we did a full scale review. Which is why I had indicated that once the specialty focus work is complete that we would then go out and meet with the broader-based constituency groups because we would have worked out any concerns in the specialty chapters prior to someone seeing the full chapters.
But at the point that we do have the full chapters ready, certainly we will be making that available and we will be providing information through the Coordination and Maintenance Committee process on where we stand with ICD-10- CM. And I am sure that people will obviously want to help us at that point and give additional recommendations.
MS. COLTIN: Other questions?
[No response.]
Well, I have a question for Dr. Harris. We have heard that there are certainly processes of care that are delivered by non physicians, who I understand are now represented on the CPT committee, but when we hear about the numbers, the numbers of additional interventions, whether it is nursing interventions or others that might need to be accommodated in an expanded CPT system, I was curious how many open slots you have in CPT and what type of modification, if you do not think you can accommodate it with the current structure, what kind of structural modifications you might need to make?
DR. HARRIS: Well, I think we could accommodate it. Let me briefly tell you. We have a CPT Editorial Panel that is 16 people and that is who actually do the summation of the work and the final, they are in charge of the book, if you will. That is just a small portion of the work. We have our advisory committee, formally organized, that has over 100 societies and organizations represented, specialty societies, non physicians, so that that is expandable to any size that, people who want to participate in it. So there is not any limit to the number of people we can include in that process. We have annual meetings with all those people. They all represent their organizations. So that it is, I think, infinite as far as the number of organizations.
We have ten or twelve non physician categories there. As far as the actual panel itself that prepares the book, there is one non physician on that, one non M.D. on that. And we have Blue Cross/Blue Shield, HIAA, HCFA and American Hospital Association and the other people tend to be a variety of people with special interests. If you see one coding issue is going to be a problem you like to have somebody that is particular in that.
Now the panel itself rotates. They are four-year terms, two four-year terms. So that there is, for the majority of members there is at least that much turnover.
MS. COLTIN: I think I might not have been clear about my question. I was not concerned about the number of people, I was concerned about the availability of unused codes in your system. You have a five-digit coding system. I do not know how many additional codes you are able to incorporate to represent the activities of different provider groups.
DR. HARRIS: Well, I am sorry I misunderstood your question. Yes, obviously, there is a limit if you have five numbers. We are doing now, we have lots more codes so we do not think we are going to run out, but one thing that we are using within, and still call it a five-digit system, are modifiers. And we do have 20 or 25 modifiers that are used very usefully because that modifier can be used with perhaps 100 or 200 codes so that you do not have to have a book 20 times bigger just so you list each item separately. So with the use of modifiers with the five-digit system, we have been able to facilitate keeping the size of the book small enough to where physicians can pick it up. So we do not have a problem at this point with running out of codes. I think it depends on where you went in the future. If you took all the nursing profession with all their kind of codes that we heard some about today, you would have to look at that situation. I do not see that we have a problem running out of codes with the kinds of things that we are doing now and what our plans are. And we so far have been able to accommodate any group that has come to us and wants to participate in the process and would look forward to doing that in the future.
MS. COLTIN: Other questions?
DR. IEZZONI: I would like to ask the three nursing classification developers, there has been over the last day a strong sense from a number of the panelists that they wanted single diagnostic coding system, a single procedure classification system, but yet, the three of you, talking about nursing systems and the presentations were appropriately, and unfortunately, brief, and so I did not really have a sense of whether the three of you are overlapping. Whether if we drew a Venn diagram of nursing classification whether you would be all on top of each other or whether you would be spread out and how much the overlap would be.
And if we said, well, we want a single nursing classification system, what would be the implications of that kind of statement for you. I think maybe each of your should answer that.
DR. WARREN: I think when you talk about a Venn diagram, that is probably one of the best things, there would be a core that would be the same across all the nursing diagnoses. And right now there are only three classifications that have nursing diagnosis information in them.
There are three classifications that have intervention. One of them is not here. And you would probably see a core that is shared there.
I think when you look at the history of our work, NANDA certainly started out first because of lots of organizational and financial needs in order to pursue that stuff. The OMAHA system probably got to press sooner because the OMAHA VNA underwrote that system. And so when you go back and look, I mean, they made a major distinction. They wanted to get something out to be the foundation of their documentation system and so because only one organization developed it all by themselves and did not have to work through consensus, that is where they came through.
We published our first document in 1974 which was prior to when Virginia started to work on her system. She started work on her system because the primary people that initially were involved in the development of NANDA were all from hospitals. And so some of the needs for data capture, especially in home health, were not being addressed within the NANDA system.
And so that is why you will see some of those kinds of relationships. I will let the others speak to add, [unintelligible] really talked about a unified kind of approach.
DR. BOWLES: When you speak of back to your Venn diagram, I would see that as the Nursing Minimum Data Set and the need to capture 16 critical items which nursing has identified as necessary to describe patient care. And, any of these systems, some of them, as Judy said, only focus on the nursing problems or diagnoses and others are full complementary systems that contain all the components of nursing care; the diagnosis, the interventions and outcomes pieces.
The way I have seen nursing move in this direction is, much like the Unified Medical Language System we have looked toward the Unified Nursing Language System where you have a medithesaurus type structure that could crosswalk these systems. And if in clinical use a home care classification system worked better in a home care setting than one that was created from acute care documentation, the person, the agency, nurse, whoever, could choose which system they wanted to use and behind the scenes would be this ability to crosswalk for aggregate data to adopt the terms.
DR. SABA: We are, we are trying to examine these problems. We are having a meeting with the American Medical Informatics Association next month where all the developers of nursing systems are coming together to see if we could share or not share, see what is going on. As you can see, individual research was done by individual universities, you know, organizations and now that we have our schemes accepted, validated and in the UMLS, we now have to move probably to a next level. They have been also all included in the International Classification of Clinical Nursing Practice, so, again, the nurses around the world are rallying forth to get their vocabulary heard, their vocabulary established and coded for a computer-based patient record.
So we feel it is critical and that is the push behind all of us. It is all individual efforts but they are all going at different pieces of the pie right now.
DR. BOWLES: Work has begun also to look at comparisons of the systems. I was involved in a project at the University of Pennsylvania where we took seven different nursing classification systems and used them all in the same data set, pulling out the terms from the record and coding them using those systems to begin work looking at a comparison of how do these terms crosswalk with each other. So it is beginning.
DR. WARREN: In response to your second question about would we ever go to a uniform, within the ANA they have taken, the current stance -- that does not mean that it might not change in the future -- but currently because of the different environments that nursing is practicing and because of the different ways that we develop our systems, either through research funding, which, by the way, has dried up, so, I mean, we are kind of out of the ball park in that, that ANA supports what we are calling the Unified Nursing Language System and that is being developed through our collaboration and with the National Library of Medicine. And that our intent is as the systems are put in, I think at this point, I think, Betsy, all of them have been --
MS. HUMPHREY: The four that you mentioned, except we do not have the NIC(?) activities levels. We are trying to see if we can work that in --
DR. WARREN: All those have been put into the medithesaurus and it is our intent, then, to explore that set and the linkages to also try to do this, as well as to encourage the research that Kathy is talking about. I think there are a lot of us that have been pulling out our own data sets from our places of work, and by data sets, I mean actual charts, patient records, and then testing a variety of nomenclatures on them.
But at this point I do not see us going to a uniform, a one nursing classification. The professional organization has not chosen to endorse that yet.
DR. SABA: We have chosen to stay independent and let each one do their own research and expand in their own focus. ICD took 100 years to get to where it is right now. We have only been working on this for less than, some 20 but most of us less than 10 years. We have a long way to go. We have a lot of growing to do before we can all merge into one when many of the other disciplines cannot merge into one right now either.
MS. COLTIN: Okay, Jeff had a question.
MR. BLAIR: You were saying that this next month you are going to be all meeting together in an AMIA(?) --
DR. SABA: Yes, one day, a pre-conference --
MR. BLAIR: If there is anything that comes out of that that might be useful to the committee in terms of clarifying the different roles or market segments you are addressing, maybe you could get that back to us?
DR. WARREN: Our intent is to develop a monograph and/or series of publications that will appear in JAMIA(?). The reason we have pulled everybody together, and it is an invitation-only conference that is bringing together developers of the nomenclatures, researchers and vendors so that we are getting, you know, the right players at the table -- at least we hope we have done that -- together to really create a position paper of kind of the state of the art of where we are and make some recommendations of where to go next.
So as soon as we have that put together, definitely we will forward it to this committee.
DR. SABA: This is a publication that just came out. It is dated March/April, Computers in Nursing, and it has a series of articles in here on the computerized patient record. It was a national work group for the Minimum Data Set held in Dayton, Ohio, June, 1996. And all the papers are compiled in here and there is a series of articles on all the vocabularies that you heard today that are also in this document. So this was the first publication of putting them all together.
MS. COLTIN: Thank you. I think we will take one last question. Dr. [unintelligible]?
PARTICIPANT: Actually, it is a partial answer.
MS. COLTIN: Okay, good.
[Laughter.]
PARTICIPANT: I finally heard a question for which I could supply a partial answer. The question was how many codes would there be room for in CPT? Now, if it went to alphanumeric, as does ICD-10-PCS, which uses a base of 34 alphanumeric characters, five to the 34th is exactly how many codes would be possible in CPT. And the reason it is a partial answer is the limit on Lynette's calculator --
[Laughter.]
-- was five to the 13th which was 1.2 billion and a few odd hundred million.
PARTICIPANT: Not nearly enough.
[Laughter.]
MS. COLTIN: Well, on that note unless there are any burning questions that we have not addressed, I would like to adjourn the meeting. Does anyone have anything they absolutely feel they need to ask the panelists?
MR. MOORE: We are going to be finished by next February.
[Laughter.]
MS. COLTIN: All right, then we are adjourned. Thank you all very much.
[Whereupon the meeting was adjourned at 5:10 p.m., April 16, 1997.]